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The parent of a 12-year-old male enrollee has requested reimbursement and prospective authorization and coverage for intravenous immune globulin therapy. The Health Insurer has denied this request indicating that the services at issue were and are investigational for the treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a 12-year-old male enrollee has requested reimbursement and prospective authorization and coverage for intravenous immune globulin therapy. The Health Insurer has denied this request indicating that the services at issue were and are investigational for the treatment of the enrollees medical condition. The physician reviewer found IVIG treatment is clinically supported in this patients case. In the treatment of autoimmune encephalitis, studies support steroids, IVIG and plasma exchange as first-line treatment and second-line treatment with rituximab and cyclophosphamide. In many cases, this is followed by steroid-sparing agents in the long-term. Autoimmune encephalitis is a rare condition and randomized controlled therapeutic trial data are limited for autoimmune encephalopathy, due to its low prevalence and due to the heterogeneous group of disorders that fall under this heading, which require very different therapeutic approaches. Fortunately, autoimmune encephalopathy typically responds quickly and completely to steroid therapy alone; however, this patient has a steroid allergy. For patients who are intolerant of steroids, weekly IVIG is found to be effective. For these reasons, the services at issue were and are likely to be more beneficial for treatment of the patients medical condition than any standard therapy.Based upon the information set forth above, the services at issue were and 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.
| 0 |
A 31-year-old female enrollee has requested authorization and coverage for Avastin. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 31-year-old female enrollee has requested authorization and coverage for Avastin. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found central nervous system tumors are classified by the WHO based on their proliferative potential, morphology, and molecular genetics and are conferred grades I-IV. Glioblastoma multiforme are high grade tumors that are best treated with resection, radiation therapy, and chemotherapy. Most GBM tumors recur and then the treatment options are limited. In this case, the patient has had a recurrence. Avastin is medically necessary and approved by the U.S. Food and Drug Administration (FDA) for recurrent GBM (Cohen, et al). Its use in this clinical setting is consistent with FDA approval and strongly supported by medical evidence. Therefore, Avastin is medically necessary for treatment of the patients medical condition. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 52-year-old male enrollee has requested reimbursement for substance abuse subacute residential treatment center services provided from 10/27/13 through 12/01/13. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
. Upon admission, the patient had a normal mental status examination. He was motivated to make total lifestyle changes and stay sober. He had maintained 101 days of sobriety earlier in the calendar year. He had supportive friends and family, and safe housing. Although the patient had met with a psychiatrist, and also had therapy focusing on self-esteem and occupationally-based leadership struggles, there was
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Upheld
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Medical Necessity
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Summary Reviewer
A 52-year-old male enrollee has requested reimbursement for substance abuse subacute residential treatment center services provided from 10/27/13 through 12/01/13. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. Upon admission, the patient had a normal mental status examination. He was motivated to make total lifestyle changes and stay sober. He had maintained 101 days of sobriety earlier in the calendar year. He had supportive friends and family, and safe housing. Although the patient had met with a psychiatrist, and also had therapy focusing on self-esteem and occupationally-based leadership struggles, there was no evidence in the record that the patient had engaged chemical dependency treatment services during the episode of illness, such as substance use counseling, anti-craving medication, sober living environments, intensive outpatient programming or partial hospitalization. This is significant because modern psychiatric practice favors treatment in the community as outcome measures and therapeutic gains are optimized in this environment. In sum, the record does not reflect that comprehensive, evidence-based services provided in a less restrictive setting would have been inadequate at the time. All told, substance abuse subacute residential treatment center services provided from 10/27/13 through 12/01/13 were not medically indicated for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 64-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees prostate cancer.
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Upheld
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Experimental
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Summary Reviewer 2
A 64-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that the most National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer acknowledge ongoing studies but caution that there is no clear evidence supporting a benefit or decrement to proton therapy over [intensity modulated radiation therapy] IMRT for either treatment efficacy or long-term toxicity. To date, there is a paucity of compelling data to suggest that proton therapy is superior to or more beneficial than IMRT. The current standard of care for prostate cancer is to offer proton beam therapy only as a part of a clinical trial and not as a substitute for IMRT. Thus, the requested proton beam radiation therapy is not supported 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 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 47-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).T
In this case, the patient presents with documented GERD based on having developed Barretts esophagus. However, the records show that the patient has benefited to a significant degree from
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Upheld
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Experimental
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Summary Reviewer 3
A 47-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).The physician reviewer found that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In this case, the patient presents with documented GERD based on having developed Barretts esophagus. However, the records show that the patient has benefited to a significant degree from Dexilant treatment, and as such cannot be considered medically refractory to acid blocker drugs. Also, implantation of LINX in the clinical setting of Barretts esophagus must be approached with caution since LINX has not been adequately studied in patients with Barretts. Therefore, it cannot be concluded that LINX is likely to be more beneficial for treatment of the patients GERD than any standard therapy. All told, the request for the LINX procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 65-year-old male with a history of history of acute respiratory failure, tracheostomy, ventilator dependent, dysphagia, seizure disorder, encephalopathy, hyperthyroidism, hyperglycemia, hyperlipidemia, polyneuropathy, and chronic obstructive pulmonary disease (COPD). The records indicate the patient was ventilator dependent with a tracheostomy and feeding tube secondary to a chronic seizure disorder status post brain surgery in March 2015. He was hospitalized in long-term care from 3/9/15 until 1/11/17. The patients provider and representatives report that the patient required skilled nursing care during this period. The patients representative has requested reimbursement for the inpatient services provided at Goldstar and Beachwood Rehabilitations Centers provided from 10/30/15 through 1/10/16 and from 4/22/16 through 1/11/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary.
This patient had a very complex, evolving combination of medical issues that required ongoing evaluation and skilled
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 65-year-old male with a history of history of acute respiratory failure, tracheostomy, ventilator dependent, dysphagia, seizure disorder, encephalopathy, hyperthyroidism, hyperglycemia, hyperlipidemia, polyneuropathy, and chronic obstructive pulmonary disease (COPD). The records indicate the patient was ventilator dependent with a tracheostomy and feeding tube secondary to a chronic seizure disorder status post brain surgery in March 2015. He was hospitalized in long-term care from 3/9/15 until 1/11/17. The patients provider and representatives report that the patient required skilled nursing care during this period. The patients representative has requested reimbursement for the inpatient services provided at Goldstar and Beachwood Rehabilitations Centers provided from 10/30/15 through 1/10/16 and from 4/22/16 through 1/11/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary. According to the Centers for Medicare and Medicaid Services (CMS) guidelines, the medical records provided for review demonstrate that the level of care the patient received from 10/30/15 through 1/10/16 and from 4/22/16 through 1/11/17 were of a higher level than standard custodial care and were medically necessary. Throughout the records, there are numerous instances of documented skilled care and physicians orders for wound care, physical therapy as well as medical specialty consultations, laboratory and radiographic testing. This patient had a very complex, evolving combination of medical issues that required ongoing evaluation and skilled medical care. Review of the medical records indicates that the care he received during the disputed date ranges does not fit the definition of custodial care. The patient received skilled care that was medically necessary to treat his frail, evolving condition. Thus, the inpatient services provided at Goldstar and Beachwood Rehabilitations Centers provided from 10/30/15 through 1/10/16 and from 4/22/16 through 1/11/17 were medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
patient is a 47-year-old female who presented to her provider on 11/29/22. The records noted
a diagnosis of Susac syndrome, currently treated with intravenous immunoglobulin (IVIG) and
rituximab. The patient has requested authorization and coverage for Panzyga SOL 5 gm/50 mL.
The Health Insurer has denied this request and reported that the requested medication is not
medically necessary for the treatment of this patient.
. In this case, the patient has a diagnosis of
Susac syndrome and has demonstrated symptom improvement with IVIG treatments. The records
indicate that the patient has tried and failed treatment with Cellcept and has derived minimal
benefit with corticosteroid infusion and rituximab.
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Overturned
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Medical Necessity
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Summary
The patient is a 47-year-old female who presented to her provider on 11/29/22. The records noted
a diagnosis of Susac syndrome, currently treated with intravenous immunoglobulin (IVIG) and
rituximab. The patient has requested authorization and coverage for Panzyga SOL 5 gm/50 mL.
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. Marrodan and colleagues describe Susac syndrome
as an autoimmune disease affecting the endothelial cells, leading to symptoms of encephalopathy,
visual disturbances, and sensorineural hearing impairment. Susac syndrome is commonly treated
with immunosuppressive therapies such as corticosteroids, IVIG, Cellcept, rituximab, and/or
cyclophosphamide. As patients treated with corticosteroids alone may initially respond well but
later relapse spontaneously or following a decrease in corticosteroids, IVIG therapy is
recommended for all patients with Susac syndrome. In this case, the patient has a diagnosis of
Susac syndrome and has demonstrated symptom improvement with IVIG treatments. The records
indicate that the patient has tried and failed treatment with Cellcept and has derived minimal
benefit with corticosteroid infusion and rituximab. Given that current medical literature supports
the use of IVIG in the treatment of Susac syndrome, the requested medication is medically
indicated. Therefore, Panzyga SOL 5 gm/50 mL is medically necessary for the treatment of this
patient.
| 1 |
A 57-year-old female enrollee has requested reimbursement for Afirma Thyroid FNA Analysis performed on 12/4/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
, the patient underwent an Afirma gene classifier analysis which was suggestive of a benign nodule, and she was able to avoid an
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Overturned
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Experimental
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Summary Reviewer 1
A 57-year-old female enrollee has requested reimbursement for Afirma Thyroid FNA Analysis performed on 12/4/14. 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 that although FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was thyroid cancer was via surgical excision (Miller, et al). The Afirma Thyroid FNA Analysis utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is suggestive of a benign nodule and can preclude such surgical procedures (Duick et al). In this case, the patient underwent an Afirma gene classifier analysis which was suggestive of a benign nodule, and she was able to avoid an unnecessary surgery. For the reasons provided above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were 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 42-year-old male enrollee has requested authorization and coverage for Tremfya. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 42-year-old male enrollee has requested authorization and coverage for Tremfya. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that Psoriasis is a chronic inflammatory skin disease. Patients typically present with sharply demarcated, inflammatory, erythematous plaques with characteristic silver-white scaling due to epidermal hyperproliferation and parakeratosis secondary to the inflammation. Psoriasis has a high negative impact on the quality of life, especially in patients moderately or severely affected by the disease. 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 (anti-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. The best-documented association is non-melanoma skin cancer with psoralen plus ultraviolet A therapy and cyclosporine. In addition, patients treated with anti-TNF drugs may develop adverse events, such as infections, acute infusion and injection reactions, autoimmunity and cardiovascular effects. Anti-TNF biologic therapies of psoriasis patients increase the risk for malignancy and infection, mandating prior testing for tuberculosis. Tremfya has been recently approved by U.S. Food and Drug Administration for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya represents a promising therapy, providing an alternative mechanism of action with high efficacy and safety profiles, sustained total skin clearance, and rapid onset of effect in psoriasis patients. Therefore, Tremfya is likely to be superior over other available treatment options.
| 1 |
A 40-year-old female enrollee has requested reimbursement for testing for inherited thrombophilic disorders performed on 10/19/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
this patient has a history of recurrent pregnancy loss and has tested positive for MTHFR mutation.
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Upheld
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Experimental
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Summary Reviewer 1
A 40-year-old female enrollee has requested reimbursement for testing for inherited thrombophilic disorders performed on 10/19/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient has a history of recurrent pregnancy loss and has tested positive for MTHFR mutation. Although this is cited by her provider as a risk factor for pregnancy loss, based on the current literature, it is unclear if MTHFR polymorphisms independently increase the risk of pregnancy loss. Diagnostic testing, including an immunology and thrombophilia work-up, is recommended for recurrent pregnancy loss. However, the minimum immunology work-up for women with recurrent pregnancy loss is measurement of anticardiolipin antibody (IgG and IgM) and lupus anticoagulant. Specifically in regards to thrombophilia testing, there is contradictory literature on the association between maternal inherited thrombophilia and recurrent spontaneous abortion occurring in the first trimester. Evaluation for an inherited thrombophilia can be considered in rare cases of recurrent, unexplained late fetal loss (after nine weeks of gestation) associated with evidence of placental ischemia and infarction and maternal vessel thrombosis. Based on the above information, there is a lack of clinical data to support the above work-up in this patient. Therefore, testing for inherited thrombophilic disorders performed on 10/19/19 was not likely to have been more beneficial than other available methods of evaluating this patient.
| 1 |
A 31-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/11/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 31-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/11/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma class, in patients who had undergone sentinel node biopsy. However, it is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear if the assay can be used prospectively to make clinical decisions. National Comprehensive Cancer Network guidelines do not recommend the services at issue in this clinical setting. Therefore, DecisionDx-Melanoma testing performed on 12/11/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 43-year-old female enrollee has requested authorization and coverage for immune globulin injection 500 mg (Gamunex-C). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
to treat her recurrent pregnancy loss thought to be of autoimmune nature with intravenous immune globuli
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Upheld
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Experimental
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Summary Reviewer 2
A 43-year-old female enrollee has requested authorization and coverage for immune globulin injection 500 mg (Gamunex-C). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is limited high-quality data on the management of recurrent pregnancy loss. Currently, therapeutic recommendations are largely based upon clinical experience and data from observational studies. This patients provider seeks to treat her recurrent pregnancy loss thought to be of autoimmune nature with intravenous immune globulin (IVIG). The studies cited by the provider are observational and pre-date current systematic reviews. Systematic reviews have consistently found no beneficial effect of immunotherapy for treatment of recurrent pregnancy loss. Wong and colleagues performed a systematic review of 20 trials of high-quality. The authors noted that immunotherapy did not result in a statistically significant improvement in live births compared to untreated controls. Treatment with intravenous immune globulin was included in this study. In sum, immune globulin injection (Gamunex-C), 500 mg is not likely to be superior over other available treatment options.
| 1 |
A 26-year-old female enrollee has requested reimbursement for laboratory services (CPT code 83993) performed on 10/5/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees structuring ileocolic Crohns disease.
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Overturned
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Experimental
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Summary Reviewer 1
A 26-year-old female enrollee has requested reimbursement for laboratory services (CPT code 83993) performed on 10/5/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees structuring ileocolic Crohns disease. The physician reviewer found that various studies have found that fecal calprotectin correlates with endoscopic finding of inflammation and serum markers of inflammation in Crohns disease (Mao, et al; Kopylov, et al). Further studies have found that fecal calprotectin is useful to assess disease activity in Crohns disease (Walsham, et al). The test allows non-invasive assessment of Crohns disease. The American Gastroenterological Association (AGA) guidelines for the management of Crohns disease recommend fecal calprotectin to assess disease activity in patients with Crohns disease. For these reasons, the laboratory services (CPT code 83993) performed on 10/5/17 was likely to be more beneficial for evaluation of this patients Crohns disease 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.
| 0 |
A 60-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/15/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas melanoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 60-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/15/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas melanoma. 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 a bit to these statistics. DecisionDx-Melanoma testing is a 31-gene assay of molecular pathology in an individualas melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification, in patients undergoing sentinel node biopsy. It is not clear how the five-year DecisionDx Melanoma data compares to the ten-year Balch data. Most importantly, it is unknown if it can be used to make clinical therapeutic decisions. This would be particularly true in this patient with an excellent prognosis. Therefore, DecisionDx-Melanoma testing performed on 4/15/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
The parent of a 16-year-old female enrollee has requested reimbursement for intra-operative
electromyography (EMG) monitoring and neuromuscular junction testing during spinal surgery
including anterior cervical procedures on 2/14/22. The Health Insurer has denied this request
indicating that the services at issue were investigational for the treatment of the enrollee.T
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Overturned
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Experimental
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Summary Reviewer 3 The parent of a 16-year-old female enrollee has requested reimbursement for intra-operative
electromyography (EMG) monitoring and neuromuscular junction testing during spinal surgery
including anterior cervical procedures on 2/14/22. The Health Insurer has denied this request
indicating that the services at issue were investigational for the treatment of the enrollee.The
physician reviewer found that while there may be limitations with respect to the degree of
impairment measured during intraoperative monitoring, particularly with less invasive
methodologies, the aggregate evidence in current medical literature uniformly supports this
adjunctive approach to measuring spinal cord integrity and the potential for spinal cord injury. As
operator skill and experience may vary widely during this type of surgery, and the potential for
negative outcomes can be devastating in terms of postoperative morbidity, the service at issue was
in keeping with best medical practice in the clinical setting of surgical repair of this patients
scoliosis. Therefore, intra-operative EMG monitoring and neuromuscular junction testing during
spinal surgery including anterior cervical procedures on 2/14/22 was likely to have been more
beneficial for treatment of the patients condition than any available standard therapy.
| 1 |
A 62-year-old male enrollee has requested authorization and coverage for positron emission tomography (PET) scan. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 62-year-old male enrollee has requested authorization and coverage for positron emission tomography (PET) scan. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the requested services in this clinical setting. Nanni and colleagues noted that evaluation of multiple myeloma bone disease at diagnosis should include both magnetic resonance imaging (MRI) of the spine and (18)F-FDG positron emission tomography/computed tomography (PET/CT). Zamagni and colleagues noted that PET/CT may provide additional and valuable information for the assessment of myeloma bone disease in areas not covered by MRI. Therefore, the requested PET scan is likely to be of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the requested services are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 46-year-old female enrollee has requested authorization and coverage for bone marrow
aspiration (38220). The Health Insurer has denied this request and reported that the requested
services are investigational for the treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 46-year-old female enrollee has requested authorization and coverage for bone marrow
aspiration (38220). 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 tibial fracture and nonunion is a known complication of tibial tubercle
osteotomy surgery. Achieving healing of established long bone nonunions is difficult, and standard
treatment includes both internal fixation and grafting. Grafting with the patients own bone has
long been considered the most effective way of achieving healing. Konda and colleagues noted,
Given the high union rate, autogenous iliac crest bone grafting for tibial nonunion remains the
gold standard for this difficult condition. However, surgically removing bone from the iliac crest
carries its own complications, and more recently multiple peer-reviewed scientific studies have
compared bone marrow aspirate and concentration as a way of transplanting live bone cells to
stimulate fracture nonunion healing without surgical removal of bone. Multiple studies in various
clinical settings, including treatment of long bone nonunions, hindfoot fusions and spinal fusions,
have found bone marrow aspirate to be equally effective to surgical harvest of bone with the
advantage of less patient pain and risks of complications related to harvest of bone. In this case,
the provider has recommended bone marrow aspirate as an alternative to harvest of bone graft for
the treatment of the patients established tibial nonunion. Bone grafting for established nonunion
is a component of standard treatment of tibial nonunion. Thus, the bone marrow aspirate is
medically appropriate. The proposed bone marrow aspirate is not in addition to standard treatment,
rather it is an alternative to more traditional surgical harvest of bone with the advantage of being
more minimally invasive and carrying less risk of complications. Iliac bone marrow aspirate is
likely to be more beneficial than treatment of the patients tibial nonunion without autogenous
bone grafting. Therefore, the requested bone marrow aspiration (38220) is likely to be more
beneficial than any available standard therapy.
| 0 |
A 28-year-old male enrollee has requested reimbursement for residential rehabilitation level of care services provided from 8/4/16 through 8/19/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse.
the patient did not present with any significant post-acute withdrawal symptoms.
. He was medically and psychiatrically stable. He was motivated, insightful, and appeared to be working the program. He reported having had a multitude of prior treatments, with the ability to maintain abstinence for a prolonged period of time.
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Upheld
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Medical Necessity
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Summary Reviewer
A 28-year-old male enrollee has requested reimbursement for residential rehabilitation level of care services provided from 8/4/16 through 8/19/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse. The physician reviewer found that this patients records did not include any psychiatric or medical admitting evaluations. In addition, the patient did not present with any significant post-acute withdrawal symptoms. The patient was not a danger to himself or to others. There were no emotional, behavioral, cognitive, or impulsive symptoms that would warrant RTC level of care. He was medically and psychiatrically stable. He was motivated, insightful, and appeared to be working the program. He reported having had a multitude of prior treatments, with the ability to maintain abstinence for a prolonged period of time. Relapse risk is inherent among this population but is not alone an adequate reason to keep a patient at a higher level of care in the absence of unstable psychiatric illness or the potential for harm to self or others. Given the recidivistic nature of his illness with multiple relapses and subsequent treatments, he had the groundwork of relapse prevention education. His difficulties with abuse and relapse were chronic in nature and did not require 24-hour monitoring at the RTC level of care in the absence of unstable medical or psychiatric conditions. He could have safely been treated in a less restrictive level of care. Thus, the RTC rehabilitation level of care services provided from 8/4/16 through 8/19/16 were not medically necessary for treatment of this patients polysubstance abuse. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 26-year-old male enrollee has requested authorization and coverage for the LINX reflux management system. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).
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Upheld
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Experimental
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Summary Reviewer 3
A 26-year-old male enrollee has requested authorization and coverage for the LINX reflux management system. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found in this clinical setting, the requested procedure is likely to be more beneficial for treatment of this patients GERD than any available standard therapy. LINX is a minimally invasive anti-reflux procedure that has been approved by the Food and Drug Administration. In addition, medical studies indicate that LINX has been shown to be as effective and non-inferior to surgery. A systematic review of more than 6,318 abstracts, 53 cohorts and 10 controlled studies has shown that it remains unclear which patient characteristics influence postoperative success following fundoplication for GERD. All told, LINX is at least equally efficacious as fundoplication and is less invasive (Ip et al). Further, the LINX procedure is potentially reversible, while surgery is not, and is less likely to have adverse effects. For all these reasons, LINX is likely to be more beneficial for treatment of this patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure 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 57-year-old female enrollee has requested reimbursement for tumor necrosis factor antagonist testing performed on 4/04/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 57-year-old female enrollee has requested reimbursement for tumor necrosis factor antagonist testing performed on 4/04/15. 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 submitted records fail to demonstrate the superior efficacy of the services at issue. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of infliximab or adalimumab or the presence of infliximab or adalimumab antibodies have an adverse effect on the clinical outcome of a patients response to treatment. While there have been testimonials, there are few well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement. It has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. Thus, tumor necrosis factor antagonist testing performed on 4/04/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 25-year-old enrollee has requested reimbursement for bilateral nipple/areola reconstruction associated with gender reassignment surgery performed on 10/30/18. 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.
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Overturned
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Medical Necessity
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Summary Reviewer
A 25-year-old enrollee has requested reimbursement for bilateral nipple/areola reconstruction associated with gender reassignment surgery performed on 10/30/18. 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 medical necessity of the services at issue. The Health Insurer is incorrect in its understanding of the nature of the most common chest surgery for transmasculine patients. As noted by Schechter and Schechter, patients with small non-ptotic breasts can often be treated with periareolar incisions but most patients require double incision surgery with free nipple grafts, as sought by this patient. The authors noted generally, free nipple-areola grafts, as opposed to maintenance of the nipple-areola complex on the dermoglandular pedicle are the preferred techniques for nipple transposition. Olson-Kennedy and colleagues demonstrated that for transmasculine individuals, this surgical intervention positively affected both minors and young adults. In sum, bilateral nipple/areola reconstruction associated with gender reassignment surgery provided on 10/30/18 was medically necessary for the treatment of this patient.
| 1 |
A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/01/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.
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Overturned
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Experimental
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Summary Reviewer 1
A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/01/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that there is sufficient support for the service at issue in this clinical setting. Breast tomosynthesis provides advantages to radiologists interpreting mammograms, especially in women with dense tissue. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks and increase in overall diagnostic accuracy and detection of small cancers compared to two-dimensional imaging alone. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to the patient than had her examination been done with 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.
| 1 |
The patient is a 47-year-old female who presented to her primary care provider on 7/25/19 for establishment of care. The patient has requested reimbursement for vitamin D testing performed on 7/30/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 47-year-old female who presented to her primary care provider on 7/25/19 for establishment of care. The patient has requested reimbursement for vitamin D testing performed on 7/30/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that the 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 or those 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 patient does not have any chronic medical conditions that would cause vitamin D deficiency. She did not have any signs or symptoms of vitamin D toxicity or severe deficiency. Therefore, vitamin D testing performed on 7/30/19 was not medically necessary for the evaluation of this patient.
| 1 |
A 38-year-old male enrollee has requested authorization and coverage for neck surgery. The Health Insurer has denied this request indicating that the requested services are investigational for treatment of the enrollees medical condition.
. Based on the documentation submitted for review, the patient has left C6 radiculopathy with matching motor and sensory symptoms and findings. Thus, there is disc herniation at C5-6.
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Upheld
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Experimental
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Summary Reviewer 1
A 38-year-old male enrollee has requested authorization and coverage for neck surgery. The Health Insurer has denied this request indicating that the requested services are investigational for treatment of the enrollees medical condition. The physician reviewer found that the requested services are not likely to be more effective for this patient than other available options. Based on the documentation submitted for review, the patient has left C6 radiculopathy with matching motor and sensory symptoms and findings. Thus, there is disc herniation at C5-6. However, the use of Mobi-C remains controversial. There is a lack of studies demonstrating the long term safety and effectiveness of this device. There are is a lack of controlled, prospective studies that have reported the long term safety and effectiveness of this device. According to Zechmeister and colleagues
cervical total disc replacement (CTDR) is not recommended for routine use. The authors further state that Future research needs to address the relative effectiveness between CTDR and conservative treatment. All told, the requested neck surgery 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 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 42-year-old female enrollee has requested reimbursement for substance abuse partial hospitalization services provided from 8/16/14 through 9/01/14. 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.
patients opioid use disorder and concomitant abuse of benzodiazepines
. Her addiction dominated her daily routine and generated distress. Additionally, her opioid use strained meaningful relationships and caused
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Overturned
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Medical Necessity
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Summary Reviewer
A 42-year-old female enrollee has requested reimbursement for substance abuse partial hospitalization services provided from 8/16/14 through 9/01/14. 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 the submitted documentation supports the medical necessity of the services at issue. This patients opioid use disorder and concomitant abuse of benzodiazepines further exacerbated the risk for an unfavorable outcome. Her addiction dominated her daily routine and generated distress. Additionally, her opioid use strained meaningful relationships and caused significant impairment across multiple domains of functionality. In this patients case, the treatment provided was safe, appropriate and consistent with good practice. The services were reasonably expected to improve her condition and prevent a more serious episode of illness. Further, the duration of the disputed treatment was within community practice standards. All told, substance abuse partial hospitalization services provided from 8/16/14 through 9/01/14 were medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 35-year-old male enrollee has requested authorization and coverage for Actemra 400 mg/ 20 ml vial. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees anti-neutrophil cytoplasmic autoantibodies (ANCA) associated crescenti
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Upheld
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Experimental
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Summary Reviewer 2
A 35-year-old male enrollee has requested authorization and coverage for Actemra 400 mg/ 20 ml vial. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees anti-neutrophil cytoplasmic autoantibodies (ANCA) associated crescentic and immune complex glomerulonephritis. The physician reviewer found according to the Clinical Practice Guidelines for Glomerulonephritis, crescentic glomerulonephritis with ANCA is usually treated with a set of three pulsed doses of methylprednisolone, prednisone 60 gm/day followed by a taper; and cyclophosphamide for six months followed by azathioprine for 18 months. Plasmapheresis is added if there is alveolar hemorrhage and/or dialysis requirement. Recurrences are treated with rituximab. Rituximab may also be a substitute for cyclophosphamide for initial therapy. Recurrences are retreated with the same agents. However, there is a lack of medical literature supporting tocilizumab for the treatment of ANCA. All told, the request for Actemra is not likely to be more beneficial for treatment of the patients medical condition than other modalities. Based upon the information set forth above, the requested medication 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 |
patient is a 16-year-old male who underwent surgery on 7/02/19 for management of recurrent dislocation of patella with medial patellofemoral ligament tear, and associated chondromalacia and loose bodies. The procedures included left knee arthroscopy with patellofemoral chondroplasty, excision of loose bodies, tibial osteotomy and patellofemoral ligament reconstruction with allograft.
, the patient was not able to ambulate for almost nine weeks, and there was a
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 16-year-old male who underwent surgery on 7/02/19 for management of recurrent dislocation of patella with medial patellofemoral ligament tear, and associated chondromalacia and loose bodies. The procedures included left knee arthroscopy with patellofemoral chondroplasty, excision of loose bodies, tibial osteotomy and patellofemoral ligament reconstruction with allograft. The physician reviewer found that intermittent pneumatic compression is now a widely used therapy for the prophylaxis of deep vein thrombosis and pulmonary embolism, particularly after major surgical procedures on the lower extremities with prolonged immobilization. In general, the device sequence is composed of sequential compression and deflation. Typically, veins are considered to be emptied during the compression phase and refilled during the deflation phase. The device may be supplemented with pharmacotherapy for optimum deep vein thrombosis prophylaxis. In this case, the patient was not able to ambulate for almost nine weeks, and there was a clear need for deep vein thrombosis prophylaxis. As such, the intermittent limb compression device was medically appropriate. Therefore, the intermittent limb compression device provided on 7/02/19 was medically necessary for the treatment of this patient.
| 1 |
A 26-year-old male enrollee has requested reimbursement for substance use partial hospitalization services provided from 9/14/18 through 10/04/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
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Upheld
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Medical Necessity
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Summary Reviewer
A 26-year-old male enrollee has requested reimbursement for substance use partial hospitalization services provided from 9/14/18 through 10/04/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that in cases such as this, an evidence-based, objective, instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) is indispensable in determining necessary and appropriate level of care for adults. In terms of risk of harm, the records support a score of 1 due to a lack of current suicidal ideation and no self-harming behaviors. With regards to functional status, the records support a score of 2 due to an overall good functional level with appropriate activities of daily living. In terms of medical, addictive and psychiatric comorbidity, the records support a score of 2 due to overall medical stability and controlled depression and anxiety symptoms. With regards to level of stress of the recovery environment, the records support a score of 3 due to no mention of a stressful recovery environment. In terms of level of support of the recovery environment, the records support a score of 2 due to family support and availability of treatment resources. With regards to treatment and recovery history, the records support a score of 3 due to success in the partial hospitalization program with a good level of cooperation and maintenance of sobriety. In terms of engagement and recovery status, the records support a score of 2 due to cooperation in treatment and insight into his need for treatment. Thus, the patient has a composite score of 15. This score is consistent with a community-based outpatient clinic setting. Therefore, substance use partial hospitalization services from 9/14/18 through 10/04/18 were not medically necessary for the treatment of this patient.
| 0 |
The representative of a 63-year-old male enrollee has requested reimbursement for mental health inpatient treatment from 5/23/16 through 6/23/16. 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 patient was admitted on an alcohol detoxification protocol and was engaged in active treatment. He completed a benzodiazepine taper on 5/26/17. The following day he was pleasant with no signs of alcohol withdrawal. The patient had his antidepressant medication, escitalopram, increased by 50% on 5/26/17 and then again to the maximum dose on 5/30/17. He was sleeping well on a conservative dose of trazodone at nighttime. He was adherent with his medications and had no side effects. On 5/31/17, the patient was less tense, less confused and more relaxed. He was eating 75 to 100% of his meals. Although, he was isolative and labile at times, he was not disruptive on the unit. He had no suicidality, homicidal ideation, agitated behavior or psychosis. On 6/1/17, the patient was stable for discharge, which was planned for the next day. However, an issue related to the power of attorney derailed the discharge.
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Overturned
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Medical Necessity
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Summary Reviewer
The representative of a 63-year-old male enrollee has requested reimbursement for mental health inpatient treatment from 5/23/16 through 6/23/16. 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 support for a portion of the services at issue in this clinical setting. Considering the patients clinical condition and relevant history, and the potential for a complicated alcohol withdrawal syndrome, acute hospitalization represented a safe and appropriate intervention at the time of presentation. However, the record does not support the medical necessity of the setting as of 6/2/16. The patient was admitted on an alcohol detoxification protocol and was engaged in active treatment. He completed a benzodiazepine taper on 5/26/17. The following day he was pleasant with no signs of alcohol withdrawal. The patient had his antidepressant medication, escitalopram, increased by 50% on 5/26/17 and then again to the maximum dose on 5/30/17. He was sleeping well on a conservative dose of trazodone at nighttime. He was adherent with his medications and had no side effects. On 5/31/17, the patient was less tense, less confused and more relaxed. He was eating 75 to 100% of his meals. Although, he was isolative and labile at times, he was not disruptive on the unit. He had no suicidality, homicidal ideation, agitated behavior or psychosis. On 6/1/17, the patient was stable for discharge, which was planned for the next day. However, an issue related to the power of attorney derailed the discharge. In sum, the admission improved the patients clinical condition and more than likely prevented a more serious episode of illness. During the course of the hospitalization, although mildly depressed in context of chronic cognitive decline, the patients acute syndrome resolved. He was not psychotic. He was not aggressive. He was neither suicidal nor homicidal. He was responding well to psychotropic medication. He successfully completed supervised alcohol detoxification. Continued specialty care remained indicated to capitalize on the therapeutic momentum, but there was no indication that service delivery in a less restrictive setting would have been unsafe or inadequate from 6/1/16 forward. Thus, a portion of the services at issue were medically necessary. Specifically, the mental health inpatient treatment from 5/23/16 through 6/1/16 were medically necessary, but not thereafter. Therefore, for the reasons stated above, a portion of the services at issue was medically necessary for treatment of the patients medical condition. Therefore, the Health Insurers denial should be partially overturned.
| 1 |
The patient is a 24-year-old female with symptoms of plantar hyperhidrosis. Her past medical history is significant for bilateral thorascopic sympathectomy for severe palmar hyperhidrosis in 2013. The patient has attempted medical management of her condition with over the counter therapy agents such as Drysol and Robinul Forte. She reported that this condition limits her ability to function and interferes with her social life. The patient has requested reimbursement and prospective authorization and coverage for sympathectomy performed by an out-of-network provider from 2/09/17 through 5/10/17. The Health Insurer has denied this request and reported that the services at issue were and are investigational for the treatment of this patient.
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Overturned
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Experimental
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Summary Reviewer 3
The patient is a 24-year-old female with symptoms of plantar hyperhidrosis. Her past medical history is significant for bilateral thorascopic sympathectomy for severe palmar hyperhidrosis in 2013. The patient has attempted medical management of her condition with over the counter therapy agents such as Drysol and Robinul Forte. She reported that this condition limits her ability to function and interferes with her social life. The patient has requested reimbursement and prospective authorization and coverage for sympathectomy performed by an out-of-network provider from 2/09/17 through 5/10/17. The Health Insurer has denied this request and reported that the services at issue were and are investigational for the treatment of this patient. In recent years, lumbar sympathectomy has been proposed for treatment of patients with intractable palmoplantar hyperhidrosis. To date, the amount of long term, prospective evidence addressing the use of lumbar sympathectomy for the treatment of plantar hyperhidrosis is limited. Questions about efficacy, side effects and long-term outcomes have yet to be answered. Since a formal protocol/technique does not yet exist for this novel technique, the level at which surgeons perform their lumbar sympathectomy is controversial and may vary among institutions. For this reason, higher rates of complications are associated with lumbar sympathectomy than alternative treatments for hyperhidrosis. The evidence addressing the use of lumbar sympathectomy is insufficient, to date, to allow an adequate evaluation of safety and efficacy. Thus, the superior efficacy of sympathectomy performed by an out-of-network provider from 2/09/17 through 5/10/17 has not been established. Based upon the information set forth above, the services at issue were not and are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
patient is a 72-year-old male with a history of oligometastatic adenocarcinoma of his prostate gland, with disease recurrence in his left internal iliac nodal chain. The patient has requested authorization and coverage for robotic stereotactic body radiation therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
This patient has locoregionally-confined disease, which is technically curable.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 72-year-old male with a history of oligometastatic adenocarcinoma of his prostate gland, with disease recurrence in his left internal iliac nodal chain. The patient has requested authorization and coverage for robotic stereotactic body radiation therapy. 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 submitted documentation supports the medical necessity of the requested services in this clinical setting. Aggressive local treatment of oligometastatic disease has been associated with improvement in survival. This patient has locoregionally-confined disease, which is technically curable. He would not be a great candidate for salvage surgery, given the prior operation and likely presence of extensive adhesions. Furthermore, systemic therapy would not be a curable treatment option. External beam radiotherapy (in the form of intensity modulated radiation therapy or stereotactic body radiation therapy) represents his best chance for cure. In this setting, stereotactic body radiation therapy is supported by the National Comprehensive Cancer Network (NCCN) guidelines as well as the American Society for Radiation Oncology (ASTRO) Model Policy. Therefore, robotic stereotactic body radiation therapy is medically necessary for the treatment of this patient.
| 1 |
The patient is a 21-year-old male, who is under evaluation and management for gastroesophageal reflux disease (GERD). The patient has been treated with lansoprazole and pantoprazole. A recent upper endoscopy was normal, except for an irregular Z-line. The patient underwent a 96-hour esophageal power of hydrogen study and had a low prevalence of acidic reflux on each of the days. There are no episodes of long reflux. An esophagram confirmed the absence of a hiatal hernia. The patient has requested authorization and coverage for the esophageal sphincter augmentation device (CPT code 43284). The Health Insurer has denied this request as investigational.
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Upheld
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Experimental
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Summary Reviewer 1
The patient is a 21-year-old male, who is under evaluation and management for gastroesophageal reflux disease (GERD). The patient has been treated with lansoprazole and pantoprazole. A recent upper endoscopy was normal, except for an irregular Z-line. The patient underwent a 96-hour esophageal power of hydrogen study and had a low prevalence of acidic reflux on each of the days. There are no episodes of long reflux. An esophagram confirmed the absence of a hiatal hernia. The patient has requested authorization and coverage for the esophageal sphincter augmentation device (CPT code 43284). The Health Insurer has denied this request as investigational. According to the documentation submitted for review, there is a lack of evidence demonstrating the patient has a very low percentage acid exposure time (AET) of the esophagus, with very brief reflux episodes. In addition, in a young male patient, especially with refractory GERD symptoms, biopsies of the proximal and distal esophagus should be done to rule out eosinophilic esophagitis. The records do not indicate that these biopsies have been completed. Therefore, based on the clinical record, the request for esophageal sphincter augmentation device (CPT code 43284) is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. I have determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Insurers denial should be upheld.
| 1 |
A 46-year-old female enrollee has requested authorization and coverage for ketamine infusion and one day inpatient stay. The Health Insurer has denied this request indicating that the requested services are considered experimental/investigational for treatment of the enrollees peripheral neuropathy status post chemotherapy treatment.
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Upheld
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Experimental
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Summary Reviewer 1
A 46-year-old female enrollee has requested authorization and coverage for ketamine infusion and one day inpatient stay. The Health Insurer has denied this request indicating that the requested services are considered experimental/investigational for treatment of the enrollees peripheral neuropathy status post chemotherapy treatment. The physician reviewer found the requested services are not likely to be more effective for this patient than other available treatment options. There is insufficient evidence in the peer-reviewed literature to support the use of ketamine for the treatment of neuropathic pain conditions. Moreover, the safety of long-term use of ketamine has also not been established. Therefore, ketamine infusion is not likely to be more beneficial for treatment of the patients neuropathic pain than other available standard treatments. 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 43-year-old enrollee has requested reimbursement and prospective authorization and coverage for tobramycin/betamethasone/itraconazole compound from 7/25/16 and 8/3/16 and forward. The Health Insurer has denied this request indicating that the compounded medications were and are considered investigational for treatment of the enrollees chronic sinusitis.
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Upheld
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Experimental
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Summary Reviewer 1
A 43-year-old enrollee has requested reimbursement and prospective authorization and coverage for tobramycin/betamethasone/itraconazole compound from 7/25/16 and 8/3/16 and forward. The Health Insurer has denied this request indicating that the compounded medications were and are considered investigational for treatment of the enrollees chronic sinusitis. The physician reviewer found that there is a lack of evidence in the medical literature to support the superior efficacy of the compounded medications at issue in this clinical setting. While the use of budesonide in a nebulized form in treatment of chronic otherwise refractory rhinosinusitis has gained some acceptance, its use, as well as the use of steroids compounded with antibiotics and/or antifungal medication is off label and unproven in efficacy. There is very limited clinical data to support its superiority over standard forms of therapy. All told, in light of the limited clinical evidence in the literature, tobramycin/betamethasone/itraconazole compound administered on 7/25/16 and 8/3/16, forward was not, and is not likely to be more effective than the standard therapies available for treatment of this patients medical condition. Therefore, for the reasons stated above, the compounded medications were not and are not likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 50-year-old male has requested authorization and coverage for code 43210 and one inpatient bed day. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.
This patient does not have pathologic acid reflux by testing, and the records do not
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Upheld
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Experimental
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Summary Reviewer 2
A 50-year-old male has requested authorization and coverage for code 43210 and one inpatient bed day. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the requested services. This patient does not have pathologic acid reflux by testing, and the records do not support a reflux operation or procedure. Transoral incisionless fundoplication (TIF) is an endoscopic procedure performed under general anesthesia. TIF can be performed in patients with typical gastroesophageal reflux disease symptoms, no or only low-grade erosive esophagitis (grades A and B), and no or only small hiatal hernia (less than or equal to 2 cm). Although TIF is associated with fewer postoperative adverse effects, such as gas, bloating and dysphagia, compared with surgery fundoplication, the durability of TIF is less than that of surgery. Huang and colleagues performed a meta-analysis of five randomized trials and 13 prospective studies. The authors noted that proton pump inhibitor use after TIF increased over time, and the satisfaction rate was only 69.15% at six months. In sum, code 43210 and one inpatient bed day are not likely to be more beneficial than other available treatment options.
| 1 |
The parent of a 12-year-old male enrollee has requested authorization and coverage for growth hormone therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 12-year-old male enrollee has requested authorization and coverage for growth hormone therapy. 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 fails to establish the medical necessity of the requested services. According to the documentation submitted for review, the patients height is not more than 2 standard deviations below normal for age and gender, his growth velocity is within normal limits, IGF-1 is normal, and peak GH response to provocative testing is normal. Thus, the patient does not have auxological or biochemical criteria for GH deficiency. The delayed bone age and small anterior pituitary gland without evidence of midline defects or other pituitary deficiencies is most consistent with a diagnosis of constitutional delay rather than GH deficiency. The adult predicted height based on a bone age of 10 years and height measurement of 133.4 cm in 9/8/14 is 64.7 inches, not short enough to warrant a trial of GH therapy for idiopathic short stature based on U.S. Food and Drug Administration criteria. Based on the medical literature cited above and the documentation submitted for review, the requested services are not medically necessary for treatment of the patients medical condition.Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
A 64-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 8/14/19. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 64-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 8/14/19. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition. The physician
reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous
melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for
those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be
amenable to excision but this suggests a high risk for the development of metastatic disease in
the future. Such patients may be observed or treated with interferon-alpha. The data on
DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node
biopsy. There has also been some lack of consistency between various genes being used as
biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the
treatment algorithm beyond standard staging techniques. Therefore, DecisionDx-Melanoma
testing performed on 8/14/19 was not likely to have been more beneficial than any available
standard therapy.
| 0 |
The patient is a 45-year-old male with a diagnosis of amyotrophic lateral sclerosis (ALS). The patient initially presented in 2013 with right hand cramps and weakness. Nerve conduction studies showed denervation and chronic lower motor neuron changes in the left cervical, left lumbosacral, trapezius and thoracic paraspinal muscles. The patient has requested authorization and coverage for edaravone (Radicava). The Health Insurer has denied this request as investigational.
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Overturned
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Experimental
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Summary Reviewer 1
The patient is a 45-year-old male with a diagnosis of amyotrophic lateral sclerosis (ALS). The patient initially presented in 2013 with right hand cramps and weakness. Nerve conduction studies showed denervation and chronic lower motor neuron changes in the left cervical, left lumbosacral, trapezius and thoracic paraspinal muscles. The patient has requested authorization and coverage for edaravone (Radicava). The Health Insurer has denied this request as investigational. Radicava is a free radical scavenger that slows the functional deterioration in some patients with ALS. Radicava is U.S. Food and Drug Administration (FDA) approved for patients ALS without any restriction to the variant or severity of ALS. There is evidence for the benefit of Radicava in patients with early ALS which suggests Radicava would also benefit the greater ALS population. Therefore, the request for Radicava is 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 49-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 3/15/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who underwent a breast screening evaluation.
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Overturned
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Experimental
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Summary Reviewer 3
A 49-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 3/15/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who underwent a breast screening evaluation. The physician reviewer found that 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 very recent years, there have been several studies that have supported the use of breast tomosynthesis as a more accurate study than routine screening mammography. As noted by 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. Friedewald and colleagues noted the addition of tomosynthesis to digital mammography was associated with a decrease in recall rate and an increase in cancer detection rate. In this case, this patients breasts have been described as heterogeneously dense. It is specifically those patients who have 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. Thus, breast tomosynthesis performed on 3/15/17 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 55-year-old female enrollee has requested authorization and coverage for corticotropin (Acthar Gel). The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition.
this patient has been diagnosed with rheumatoid arthritis and has been treated with multiple medications, including anti-inflammatory drugs (NSAIDs), high-dose intravenous corticosteroids, methotrexate, Arava, Xeljanz, Actemra, and Orencia. Per the treating provider, she has developed either side effects to the tried medications or has not responded sufficiently in terms of disease activity to the medications.
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Upheld
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Experimental
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Summary Reviewer 3
A 55-year-old female enrollee has requested authorization and coverage for corticotropin (Acthar Gel). The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has been diagnosed with rheumatoid arthritis and has been treated with multiple medications, including anti-inflammatory drugs (NSAIDs), high-dose intravenous corticosteroids, methotrexate, Arava, Xeljanz, Actemra, and Orencia. Per the treating provider, she has developed either side effects to the tried medications or has not responded sufficiently in terms of disease activity to the medications. Acthar Gel is not a recommended treatment for rheumatoid arthritis. Furthermore, there is a paucity of objective data to support that the patient has had an inadequate response to other evidenced-based medications that have been tried previously. Per the last included treatment note from September 2019, objective findings included synovitis at one joint that was chronic, and no significant deformities of any joint. The submitted documentation fails to support the requested medication in this clinical setting. Thus, corticotropin (Acthar Gel) is not likely to be more beneficial than other treatment options.
| 1 |
A 42-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 1/19/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 42-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 1/19/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the breast tomosynthesis performed on 1/19/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. 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 due to the advantages it brings radiologists interpreting mammograms especially in women with dense breast tissue such as in this case. This tomographic method often allows the reader to separate dense glandular elements from underlying mass and architectural distortion resulting in a decrease in biopsies and callbacks and increase in diagnostic accuracy and detection of small cancers compared to two-dimensional (2D) imaging alone. Thus, the addition of tomosynthesis was likely of greater benefit to the patient than had her exam been done with 2D imaging only. 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.
| 0 |
A 32-year-old female enrollee has requested authorization and coverage for Gamunex-C. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 32-year-old female enrollee has requested authorization and coverage for Gamunex-C. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the medical evidence supports the requested medication in this clinical setting. Schofield and Chemali noted, Immunoglobulin therapy has been used increasingly with significant efficacy in the treatment of patients with disabling autoimmune forms of dysautonomia, which are most often small fiber (autonomic and/or sensory) polyneuropathies. De Greef and colleagues noted that, Small fiber neuropathy is the most common cause of neuropathic pain in peripheral neuropathies. Patients experience excruciating pain, and currently available anti-neuropathic and other pain drugs do not relieve the pain substantially. Several open-label studies have suggested an immunological basis in small fiber neuropathy and have reported efficacy of treatment with intravenous immunoglobulin. Gamunex-C is an appropriate treatment in this patients case. All told, Gamunex-C is likely to be more beneficial than other available treatment options.
| 0 |
A 58-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/10/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 58-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/10/15. 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 clinical setting. Breast tomosynthesis allows providers to differentiate dense glandular elements from underlying architectural distortion which in turn has been associated with a decrease in callbacks and increase in detection of small cancers. The medical literature supports the breast tomosynthesis in this patients case. Thus, the addition of tomosynthesis to the usual two-dimensional imaging protocol was likely of more benefit for the patient than had the examination been done with the two-dimensional technique alone. 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 22-year-old male has requested reimbursement for Prometheus Anser IFX testing performed on 8/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 22-year-old male has requested reimbursement for Prometheus Anser IFX testing performed on 8/30/15. 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 submitted records fail to demonstrate the superior effectiveness of the services at issue. Some evidence exists that low serum levels of infliximab and/or the presence of antibodies to infliximab may play a role in primary or secondary response failures. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, there are few well-controlled clinical trials to confirm that use of the Anser IFX testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement. It has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. Therefore, Prometheus Anser IFX testing performed on 8/30/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 61-year-old female enrollee has requested reimbursement for laboratory testing performed on
11/29/19. The Health Insurer has denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition.
this patient was recently diagnosed with advanced non-small cell lung cancer.
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Upheld
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Experimental
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Summary Reviewer 2
A 61-year-old female enrollee has requested reimbursement for laboratory testing performed on
11/29/19. 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 this patient was recently diagnosed with advanced non-small cell lung cancer. Even if
stage IV or advanced disease is present in non-small lung cancer, therapy targeted to EGFR
mutations with erlotinib results in prolonged survival when compared with standard
chemotherapy regimens. The mutational landscape of non-small cell lung cancer has significantly
expanded in the past two to three years to encompass gain of function in multiple oncogenes
with major prognostic and therapeutic consequences. It is generally accepted that the panel of mutations that was analyzed in the patient using the Guardant 360 test is for mutually exclusive
somatic driver mutations. Generally, KRAS, TP53, and BRAF are also included in these panels and
are informative. The NCCN does not promote brand name products such as Guardant 360 and so
the specific test is not mentioned but comprehensive mutational testing is mentioned and
recommended. Therefore, laboratory testing performed on 11/29/19 was likely to have been
more beneficial than any available standard therapy.
| 1 |
A 45-year-old female enrollee has requested reimbursement for FoundationOne gene testing performed on 3/26/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees adenosarcoma of the cervix.
patient has a rare form of cancer and she has exhausted conventional therapies for treatment.
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Overturned
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Experimental
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Summary Reviewer 3
A 45-year-old female enrollee has requested reimbursement for FoundationOne gene testing performed on 3/26/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees adenosarcoma of the cervix. The physician reviewer found this patient has a rare uterine sarcoma that has not been extensively studied. A study of 86 patients where the progression-free survival on regimen selected by molecular profiling was compared to progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage (Von Hoff, et al). This trial has very significant results for patients with stage IV tumors. The results from molecular profiling offer a rational selection of the next regimen. This patient has a rare form of cancer and she has exhausted conventional therapies for treatment. Thus, the submission of her tissue for analysis to FoundationOne, in an effort to guide next steps in her treatment, was likely more beneficial than conventional therapies. 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 47-year-old male enrollee has requested reimbursement for the Oncotype Dx Colon Cancer Assay provided on 2/14/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectosigmoid cancer.
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Upheld
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Experimental
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Summary Reviewer 2
A 47-year-old male enrollee has requested reimbursement for the Oncotype Dx Colon Cancer Assay provided on 2/14/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectosigmoid cancer. The physician reviewer found that the Oncotype DX test uses a reverse transcriptase polymerase chain reaction assay for 12 genes in an algorithm that can be used to help predict recurrence (OConnell, et al; Gray, et al). Despite this support, it has not been established whether adjuvant chemotherapy can obviate recurrence risk. Overall, the current data does not support use of the Oncotype DX as a predictive marker for response to adjuvant treatment (Benson and Hamilton; Gray, et al). As such, the National Comprehensive Cancer Network (NCCN) guidelines state that there are insufficient data to recommend use of multi-gene assay panels to determine adjuvant therapy. All told, the Oncotype DX Colon Cancer Assay provided on 2/14/18 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 16-year-old non-binary individual with a history of attention-deficit/hyperactivity
disorder (ADHD), autism spectrum disorder, major depressive disorder with psychotic features,
generalized anxiety disorder, obsessive-compulsive disorder, suicidal ideation, and self-harm
behaviors. The Health Insurer has denied the patients residential treatment level of care
provided from 9/3/21 through 9/8/22 as not medically necessary for the
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 16-year-old non-binary individual with a history of attention-deficit/hyperactivity
disorder (ADHD), autism spectrum disorder, major depressive disorder with psychotic features,
generalized anxiety disorder, obsessive-compulsive disorder, suicidal ideation, and self-harm
behaviors. The Health Insurer has denied the patients residential treatment level of care
provided from 9/3/21 through 9/8/22 as not medically necessary for the treatment of the
patients medical condition. The physician reviewer found that (CASII) into a single instrument,
the Child and Adolescent Level of Care/Service Intensity Utilization System (CALOCUS-CASII). This
instrument is a standardized tool used to determine the intensity of services needed for children
and adolescents, 6-18 years of age, presenting with psychiatric, substance use, medical and/or
developmental concerns. Using CALOCUS-CASII, providers score patients on a scale of 1-5 using
a six-pronged Dimensional Rating System. The six dimensions include: (1) risk of harm; (2)
functional status; (3) co-occurrence of developmental, medical, substance use and psychiatric
conditions; (4) recovery environment (a. stressors and b. supports); (5) resiliency and response
to services; and (6) engagement. The composite score is then used to determine the level of care
needed. Applying the CALOCUS-CASII framework, the patient did not meet the criteria for the
residential treatment level of care provided from 9/3/21 through 9/8/22. For dimension 1, the
patient was at some risk of harm (score 2), as the patient had mild suicidal ideation with no intent
or conscious plan and with no past history. The records provided for review reflect that the
patient presented with a history of self-harm and suicidal ideation but no suicide attempts. The
records reflect that during their stay at RTC, the patient endorsed suicidal ideation but had no
plan or desire to act on those thoughts. There is also no indication that the patient self-harmed
during their stay at RTC. For dimension 2, the patient demonstrated moderate functional
impairment (score 3). The records reflect that during the patients stay at RTC, there were no
issues with the patients eating, sleep, or hygiene. The patient was compliant in the classroom
and participated appropriately in the program. Overall, recent gains and/or stabilization were
achieved while participating in treatment in a structured, protected, and/or enriched service. For
dimension 3, the patient had significant co-occurrences (score 3). The patient presented with
neurodevelopmental disorders, including autism and ADHD, in addition to their psychiatric
disorders. Overall, a developmental disability was present that adversely affected the presenting
condition and required significant augmentation or alteration of treatment for the presenting
condition or co-morbid condition. For dimension 4A, the patients recovery environment was
moderately stressful (score 3). The patient experienced a disruption of family and social milieu
as their parents divorced when the patient was two years of age. The patient reportedly struggled
in their relationship with their father, as he was more authoritarian and had difficulty accepting
the patients gender identity. The patient struggled with peer relationships but was increasingly
able to navigate social situations with support. In addition, the records reflect that the patients
role expectations exceeded their capacity given their age, status, and developmental level. For
dimension 4B, the patients recovery environment was supportive (score 2). The patients parents
were supportive of the patients treatment as evidenced by their participation in treatment and
receptiveness to therapist feedback. Overall, the patients family was willing and able to
participate in treatment if requested to do so and had the capacity to effect needed changes. For dimension 5, the patient showed poor resiliency and response to services (score 4), as previous
treatment did not achieve complete remission of symptoms or optimal control of symptoms even
with intensive and/or repeated exposure to interventions. The records reflect that the patients
prior treatment included outpatient psychotherapy, psychiatric treatment including multiple
psychotropic medications, a partial hospital program, and inpatient psychiatric hospitalization,
all without significant benefit. For dimension 6, the patient exhibited adequate engagement in
services (score 2), as the patient passively cooperated in treatment planning and services. The
records reflect that the patient acknowledged the need for treatment, engaged in treatment, and
was compliant with medications. These findings give the patient a composite score of 19, which
is consistent with Level 4 High Intensity Community-Based Services. Therefore, the residential
treatment level of care provided from 9/3/21 through 9/8/22 was not medically necessary for
the treatment of this patient.
| 1 |
A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx TM
comprehensive genomic profiling test performed on 1/26/21. The Health Insurer has denied
this request and reported that the services at issue were investigational for the evaluation of
the enrollees medical condition.
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Overturned
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Experimental
|
Summary Reviewer 2
A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx TM
comprehensive genomic profiling test performed on 1/26/21. 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 sufficient support
for the services at issue in this setting. Many patients with metastatic breast cancer encounter
off-label therapies that may be supported by medical evidence. Von Hoff and colleagues
performed a study of 86 patients. The progression-free survival on regimen selected by
molecular profiling was compared to progression-free survival on the last chemotherapy
regimen. The authors noted that the regimen selected by molecular profiling offered a 27%
survival advantage. This trial has very significant results for patients with stage IV tumors. This
patient may be offered something off-label or a phase I/II clinical trial. The results from
molecular profiling offer a rational selection of the next regimen. More recent data on breast
cancer also supports the use of FoundationOne testing. The National Comprehensive Cancer
Network guidelines also support a role for mutational analysis. Therefore, FoundationOne CDx
TM comprehensive genomic profiling test performed on 1/26/21 was likely to have been more
beneficial than any available standard therapy.
| 0 |
A 20-year-old female enrollee has requested reimbursement for Anser IFX diagnostic test performed on 2/8/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees chronic ulcerative pancolitis.
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Upheld
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Experimental
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Summary Reviewer 1
A 20-year-old female enrollee has requested reimbursement for Anser IFX diagnostic test performed on 2/8/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees chronic ulcerative pancolitis. The physician reviewer found that there is a lack of properly conducted, prospective, controlled trials showing a benefit of the services at issue over routine tests. Monitoring patients on infliximab with measurement of infliximab levels and antibodies to infliximab continues to be an area of intense investigation. The Anser IFX test categorizes drug levels as high or low and antibody levels as high or low. However, this algorithmic approach has not been validated using prospectively controlled data. Their value as a random test to assess levels in a clinically stable patient on maintenance therapy, such as in this patients case, has yet to be established in prospective controlled trials. Therefore, the Anser IFX diagnostic test administered on 2/8/16 was not likely to have been more beneficial than any available standard therapy for the evaluation of this patients medical condition. Based upon the information set forth above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 58-year-old male. He presented to the emergency department on 8/18/20 with lower abdominal pain, nausea, and chills for two days, as well as constipation with no bowel movement for days. The patient has requested reimbursement for inpatient hospital level of care provided from 8/18/20 through 8/21/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
this case, there was a locule of free air, which suggested microperforation, leukocytosis on presentation, and distended abdomen with ileus and ongoing lack of bowel movements on the day after
. The patient improved on intravenous antibiotics and was appropriately discharged on oral antibiotics. His diet was gradually advanced as he started having bowel movements on the night after presentation.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 58-year-old male. He presented to the emergency department on 8/18/20 with lower abdominal pain, nausea, and chills for two days, as well as constipation with no bowel movement for days. The patient has requested reimbursement for inpatient hospital level of care provided from 8/18/20 through 8/21/20. 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 the submitted documentation fails to demonstrate the medical necessity of the services at issue. In patients with uncomplicated diverticulitis, outpatient management or observation is the standard of care. The safety and efficacy of outpatient management of acute uncomplicated diverticulitis has been demonstrated. A systematic review of the literature underscored this [4]. The observation level of care can be appropriate over outpatient care when there is a possible microperforation. In this case, there was a locule of free air, which suggested microperforation, leukocytosis on presentation, and distended abdomen with ileus and ongoing lack of bowel movements on the day after presentation. However, there was no protracted fever or hypotension to suggest that antibiotics were ineffective. The patient improved on intravenous antibiotics and was appropriately discharged on oral antibiotics. His diet was gradually advanced as he started having bowel movements on the night after presentation. No other cause for the inpatient level of care, such as peritonitis, toxic megacolon, bowel obstruction, sepsis, abscess, fistula, or other complication, was documented. Therefore, inpatient hospital level of care provided from 8/18/20 through 8/21/20 was not medically necessary for the treatment of this patient.
| 1 |
A 24-year-old female enrollee has requested authorization and coverage for intensity modulated radiation therapy (IMRT). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 24-year-old female enrollee has requested authorization and coverage for intensity modulated radiation therapy (IMRT). 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 goal for the treatment of Hodgkins disease in young adults is to eradicate the disease to minimize the risks of late effects secondary to therapy. The late effects of treatment have become more apparent with increased survival of Hodgkins patients. IMRT is superior to three-dimensional conformal radiation therapy (3D-CRT) for patients with bulky mediastinal disease. This is because IMRT allows a more conformal dose of radiation to mediastinal disease while at the same time delivering a lower dose to adjacent sensitive organs such as heart and lungs. The National Comprehensive Cancer Network (NCCN) Hodgkins lymphoma guidelines state Advanced radiation therapy (RT) technologies such as IMRT, breath hold or respiratory gating, image guided RT or proton therapy may offer significant and clinically relevant advantages in specific instances to spare important [organs at risk] OAR such as the heart (including coronary arteries, valves and left ventricles), and decrease the risk for late normal tissue damage while still achieving the primary goal of local tumor control. In this case, IMRT will be more beneficial treatment to avoid long-term complications in this young patient who has a very high chance of cure. 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.
| 0 |
A 50-year-old female enrollee has requested reimbursement for breast tomosynthesis imaging performed on 2/10/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented for her annual breast examination.
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Overturned
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Experimental
|
Summary Reviewer 2
A 50-year-old female enrollee has requested reimbursement for breast tomosynthesis imaging performed on 2/10/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented for her annual breast examination. The physician reviewer found that the digital mammography screening has been proven to decrease mortality related to breast cancer. Standard or two dimensional (2-D) mammography has significant limitations, namely obscuration of cancers within areas of overlapping or dense tissue, as well as false positive recalls due to overlapping breast tissue, which must be confirmed with additional imaging. Digital breast tomosynthesis addresses both of these issues as it increases the cancer detection rate. It does this by allowing the radiologist to scan through slices of breast tissue rather than seeing the breast tissue superimposed on itself. This technology is especially beneficial in patients with dense breast tissue, where the mammogram is already limited in the detection of cancer. According to the American College of Radiology position statement on breast tomosynthesis, it specifically states: To be clear: tomosynthesis is no longer investigational. Tomosynthesis has been shown to improve key screening parameters compared to digital mammography. As digital breast tomosynthesis has been proven to increase cancer detection in the screening setting, as well as decrease false positive recall rates, this patient would benefit from breast cancer screening utilizing tomosynthesis. As such, current medical literature supports that this modality is superior to standard 2-D mammography. Therefore, in this case, breast tomosynthesis imaging performed on 2/10/17 was likely to have been more beneficial for the evaluation of the patients condition than the available standard imaging. Based upon the information set forth above, the service at issue was likely to be more beneficial for the evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 32-year-old female enrollee has requested reimbursement for the gene testing performed on 8/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees behavioral health condition.
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Upheld
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Experimental
|
Summary Reviewer 3
A 32-year-old female enrollee has requested reimbursement for the gene testing performed on 8/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees behavioral health condition. The physician reviewer found that despite its promise, pharmacogenetics is not yet ready for mainstream clinical application. The American Psychiatric Association (APA) does not endorse such testing in its current clinical practice guidelines. In this case, the documentation submitted for review failed to show the patients longitudinal illness burden and extent of impairment at the time of testing, including family history, psychosocial stressors, substance use disorders and medical comorbidities. In addition, there was no mention of prior interventions used to treat panic, depression and excessive worry. Without the review of the specific type, setting and duration of psychotherapies, or, the selection, dosing and length of previous psychotropic medication trials, it cannot be inferred that the patient had exhausted standard treatments available to treat her condition. In sum, considering the relevant peer-reviewed literature and current practice standards, it is not possible to assert with any degree of confidence that the disputed gene test yielded information that significantly influenced treatment decisions, improved the patients condition, prevented a more serious episode of illness or reduced morbidity. Thus, the gene testing performed on 8/11/16 was not likely to be more beneficial for treatment of the enrollees 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.
| 0 |
The patient is a 55-year-old female who had a slip and fall injury in June 2015 followed by right knee meniscus surgery on 9/01/15. On 11/14/16, right knee magnetic resonance imaging (MRI) documented mild diminutive changes of the mid-zone and posterior horn of the medial meniscus with blunting of the free edge, mild subluxation of the weight bearing articular surface, and increased signal likely related to prior partial meniscectomy and fibrovascular scarring tissue. There was mild tricompartmental marginal osteophytosis with near full thickness hyaline cartilage loss of the medial knee compartment. There was small joint effusion without loose body. On 11/14/16, the records noted right knee pain. Conservative treatment had included corticosteroid injection in June 2016 with no relief, and hyaluronic acid injection in June 2016 with 50% relief for two to three months. She reported a significant flare-up of symptoms with hiking and walking stairs while traveling in September 2016. She had been diagnosed with osteoarthritis, and a total knee replacement had been recommended. She was being seen for a second opinion. Right knee examination documented active range of motion -2 to 125 degrees, medial joint line pain, and significant limp. X-rays of the knee demonstrated severe medial joint space narrowing. MRI was reviewed and showed medial osteoarthrosis, loss of the medial meniscus, and chondral loss. The diagnosis was right medial knee osteoarthrosis. The treatment plan recommended right medial unicondylar knee replacement. On 1/10/17, the patient underwent medial compartment partial knee replacement using the MAKO procedure. The Health Insurer has denied reimbursement
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 55-year-old female who had a slip and fall injury in June 2015 followed by right knee meniscus surgery on 9/01/15. On 11/14/16, right knee magnetic resonance imaging (MRI) documented mild diminutive changes of the mid-zone and posterior horn of the medial meniscus with blunting of the free edge, mild subluxation of the weight bearing articular surface, and increased signal likely related to prior partial meniscectomy and fibrovascular scarring tissue. There was mild tricompartmental marginal osteophytosis with near full thickness hyaline cartilage loss of the medial knee compartment. There was small joint effusion without loose body. On 11/14/16, the records noted right knee pain. Conservative treatment had included corticosteroid injection in June 2016 with no relief, and hyaluronic acid injection in June 2016 with 50% relief for two to three months. She reported a significant flare-up of symptoms with hiking and walking stairs while traveling in September 2016. She had been diagnosed with osteoarthritis, and a total knee replacement had been recommended. She was being seen for a second opinion. Right knee examination documented active range of motion -2 to 125 degrees, medial joint line pain, and significant limp. X-rays of the knee demonstrated severe medial joint space narrowing. MRI was reviewed and showed medial osteoarthrosis, loss of the medial meniscus, and chondral loss. The diagnosis was right medial knee osteoarthrosis. The treatment plan recommended right medial unicondylar knee replacement. On 1/10/17, the patient underwent medial compartment partial knee replacement using the MAKO procedure. The Health Insurer has denied reimbursement for medial compartment partial knee replacement performed on 1/10/17. Per the Health Insurer, the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. Nationally recognized evidence based medical guidelines state that knee joint replacement is well-accepted as a reliable and suitable surgical procedure to return highly symptomatic patients to better function. If only one knee compartment is affected, a unicompartmental or partial replacement may be considered. Indications for surgery include failure of conservative treatment, including exercise therapy and medications, subjective findings of stiffness, nighttime joint pain, minimal pain relief with conservative care, current significant functional limitations, age over 50 years, body mass index less than 40, and x-ray findings of significant osteoarthritis. Current peer-reviewed literature supports unicompartmental knee replacement as an effective treatment for end-stage, symptomatic unicompartmental osteoarthritis of the knee, particularly in patients younger than 65 years. This patient presented with persistent right knee pain, mild at rest and moderately severe with activity. She was status post prior medial meniscectomy in 9/01/15 with multiple flare-ups noted in the postoperative period. Functional limitations were noted in activities of daily living due to pain. Clinical examination findings were consistent with reported x-ray evidence of severe medial joint space narrowing. Reasonable and/or comprehensive conservative treatment had been tried, with inadequate relief of pain. Given the patients age, severity of medial compartment osteoarthritis, and limitations in her daily activities, the medial compartment partial knee replacement performed on 1/10/17 was consistent with evidence-based medical guidelines and peer-reviewed literature. Therefore, medial compartment partial knee replacement performed on 1/10/17 was medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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The parent of a four-year-old female enrollee has requested reimbursement for chromosomal microarray (CMA) genetic testing performed on 9/16/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation the enrollees developmental delays.
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a four-year-old female enrollee has requested reimbursement for chromosomal microarray (CMA) genetic testing performed on 9/16/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation the enrollees developmental delays. The physician reviewer found that CMA is recommended by the American College of Medical Genetics (ACMG) as a first-tier test for patients with developmental delay, intellectual disability, and/or multiple congenital anomalies (Manning, et al). Increasing numbers of patients have been found to have underlying copy number variations. As such, copy number variations on CMA may inform about possible other complications and medical risks, some of which can be screened for and treated. WS is caused by microdeletion of chromosome 7q11.23. Features of WS include cardiovascular disease, most commonly peripheral pulmonary stenosis or supravalvular aortic stenosis, distinctive facies, joint laxity, intellectual disability with specific cognitive profile and unique personality characteristics, slow growth abnormalities, and calcium abnormalities including hypercalcemia and hypercalciuria. This is an important diagnosis to make as cardiac, renal, and endocrine evaluation and ongoing care are necessary. Accordingly, the CMA genetic testing performed on 9/16/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 55-year-old female enrollee has requested reimbursement for DecisionDX-melanoma laboratory testing performed on 5/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees malignant melanoma.
this patient was staged as T1a, melanoma, with no mitoses seen.
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Upheld
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Experimental
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Summary Reviewer A 55-year-old female enrollee has requested reimbursement for DecisionDX-melanoma laboratory testing performed on 5/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees malignant melanoma. The physician reviewer found that the staging and prognosis of cutaneous malignant melanoma is classically determined by the system spelled out by Balch and colleagues. There may be some further value in adding the mitotic rate to this system. As per this system, this patient was staged as T1a, melanoma, with no mitoses seen. This would have an expected ten year survival of at least 88%. There is no information in the records submitted as to whether she had sentinel node performed. DecisionDX, melanoma assay is a study of 31 genes in melanoma cells. It then classifies that particular melanoma as either class 1 (with a 97% disease-free rate at five years) or class 2 (with a 31% disease free-rate at five years). It is not clear how DecisionDX data compares to the ten year data of the Balch determinations, and whether it can be used to make clinical practice decisions. This is particularly in question in this patients case given her pathologic findings and excellent prognosis. All told, DecisionDX-melanoma laboratory testing performed on 5/13/16 was not likely to have been more effective than other modalities for evaluating this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 13-year-old female enrollee has requested reimbursement for homocysteine testing performed on 12/31/15. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees behavioral health condition.
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Upheld
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Experimental
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Summary Reviewer 1
The parent of a 13-year-old female enrollee has requested reimbursement for homocysteine testing performed on 12/31/15. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees behavioral health condition. The physician reviewer found the testing at issue was not likely to be more beneficial than any standard therapy available. There has been some research in non-traditional treatment of ADHD utilizing standard randomized double-blinded studies; however, research studies that have correlated the role of homocysteine levels to the diagnosis and treatment of ADHD or treatment of anger issues are lacking. A study by Kim and Lee looked at whether homocysteine has been associated with cognitive impairment and various psychiatric symptoms; however, the authors, did not discuss homocysteine testing and its benefit in managing either ADHD or anger. All told, the homocysteine test was not likely to be more beneficial for evaluating the patients ADHD or anger issues 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 44-year-old female enrollee has requested reimbursement for the single photon emission computed tomography (SPECT) scan of parathyroid gland provided on 7/19/16. The Health Plan has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees hyperparathyroidism.T
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Overturned
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Experimental
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Summary Reviewer 3
A 44-year-old female enrollee has requested reimbursement for the single photon emission computed tomography (SPECT) scan of parathyroid gland provided on 7/19/16. The Health Plan has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees hyperparathyroidism.The physician reviewer found the SPECT scan of parathyroid gland provided on 7/19/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. There is also ample literature to support its use in the surgical localization of parathyroid disease. The SPECT scan helps locate the anatomical abnormality and can enhance surgical precision, leading to better clinical outcomes for the patient, as well as help to shorten operative times. In conclusion, the diagnostic procedure at issue 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 60-year-old female enrollee has requested reimbursement for collagen crosslinks laboratory tests performed on 1/2/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis.
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Overturned
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Experimental
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Summary Reviewer 2
A 60-year-old female enrollee has requested reimbursement for collagen crosslinks laboratory tests performed on 1/2/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis. The physician reviewer found that biochemical markers of bone remodeling or serum or urinary collagen crosslinks tests are useful in certain situations to monitor efficacy and compliance with therapies for osteoporosis. However, this is not yet standard of care in the medical community, though they have a role in certain clinical situations. In this patients case, the submitted records do not indicate that these tests at issue were superior to available standard therapies for evaluation and treatment of the patients osteoporosis. 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.
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The patient is a 22-year old female who has been diagnosed with bipolar I disorder, posttraumatic stress disorder, unspecified eating disorder, gender dysphoria and rule out borderline personality disorder. The patient has history of four psychiatric hospitalizations and pharmacotherapy. As part of a comprehensive evaluation, the patient completed genetic testing on 11/10/15. The patient is requesting reimbursement for the services at issue. The Health Insurer denied reimbursement for the genetic testing performed on 11/10/15 on the basis that the services at issue were investigational for the evaluation of this patients medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
The patient is a 22-year old female who has been diagnosed with bipolar I disorder, posttraumatic stress disorder, unspecified eating disorder, gender dysphoria and rule out borderline personality disorder. The patient has history of four psychiatric hospitalizations and pharmacotherapy. As part of a comprehensive evaluation, the patient completed genetic testing on 11/10/15. The patient is requesting reimbursement for the services at issue. The Health Insurer denied reimbursement for the genetic testing performed on 11/10/15 on the basis that the services at issue were investigational for the evaluation of this patients medical condition. In general, the practice of pharmacogenetics, or the tailoring of a medication regimen based on an individuals genetic organization, may well become a valuable tool in the treatment armamentarium for those plagued with psychiatric illness. However, despite its promise, pharmacogenetics is not yet ready for mainstream clinical application. Additionally, a publication from the Patel research group represents one of many promising findings, but the recommendation for future hypothesis driven confirmatory genetic studies in independent cohorts as well as testing for mechanistic interactions relevant of bipolar disorder pathophysiology, illustrates the lack of clinical reasonableness for testing at this point. In this patients case, standard pharmacotherapeutic strategies for bipolar disorder had yet to be optimized at the time of the genetic testing. In general, the use of antidepressants in bipolar illness is at the very least controversial and may in fact exacerbate the affective impairment stemming from bipolarity. This patient had multiple antidepressant trials which may have been counterproductive. Further, the records do not show that this patient had been treated with other mood stabilizing medications, most notably lithium which remains a first line option for all domains of bipolar disorder. Finally, there was no mention of electroconvulsive therapy which represents another highly effective treatment for bipolar disorder. Additionally, regarding this particular clinical scenario, there was no case specific information detailing the longitudinal history, functional impairment or contemporaneous psychosocial stressors. Lastly, the specific type, setting and outcome of evidence based psychotherapies and social cultural spiritual community activities were not presented. As such, considering the relevant peer reviewed literature and current practice standards, it is impossible to assert with any degree of confidence that the disputed gene test yielded information that significantly influenced treatment decisions, improved the patients condition, prevented a more serious episode of illness or reduced morbidity. Thus, the genotype testing performed on 11/10/15 was not likely to have been more effective than the alternative methods for the evaluation of this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 65-year-old male who underwent laboratory testing on 8/11/20. The patient has requested reimbursement for magnetic resonance elastography performed on 10/07/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.
this patient has had elevated liver enzymes and imaging showing hepatomegaly with fatty infiltration, consistent with liver
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 65-year-old male who underwent laboratory testing on 8/11/20. The patient has requested reimbursement for magnetic resonance elastography performed on 10/07/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. This denial is the subject of the appeal and determination. The physician reviewer found that this patient has had elevated liver enzymes and imaging showing hepatomegaly with fatty infiltration, consistent with liver diseases including non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, and autoimmune hepatitis. The American Association for the Study of Liver Disease (AASLD) guidelines for non-alcoholic fatty liver disease recommend assessment for liver disease, including fibrosis and cirrhosis. Magnetic resonance elastography is one method for the assessment of liver disease; it has a higher technical success rate than ultrasound elastography, superior accuracy to serum liver function testing for the detection of significant liver fibrosis, and the ability to reliably differentiate between early and late stages of hepatic fibrosis. American Gastroenterological Association (AGA) Institute guidelines for the role of elastography in chronic liver disease state that magnetic resonance elastography has considerably higher diagnostic accuracy in ruling out cirrhosis in patients who do not have cirrhosis than ultrasound elastography, and AGA Institute guidelines for the role of elastography in the evaluation of liver fibrosis recommend using magnetic resonance elastography rather than ultrasound elastography for detection of cirrhosis in patients with a risk for non-alcoholic fatty liver disease and a higher risk of cirrhosis. Given that liver disease (including non-alcoholic fatty liver disease) was suspected in this patient with elevated liver enzymes and hepatic steatosis on imaging, and guidelines recommend assessment for liver disease in such cases with modalities including magnetic resonance elastography, magnetic resonance elastography was medically indicated for the evaluation of this patients elevated liver enzymes and hepatic steatosis. Therefore, magnetic resonance elastography performed on 10/07/20 was medically necessary for the evaluation of this patient.
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The parent of a 15-year-old female enrollee has requested reimbursement for Prometheus Anser ADA testing performed on 10/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.
At that point, the patient was feeling better and did not have clinical signs or symptoms to indicate non-response to her higher adalimumab dosing.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a 15-year-old female enrollee has requested reimbursement for Prometheus Anser ADA testing performed on 10/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that measurement of adalimumab trough levels and antibodies is not investigational in the setting of inadequate response or loss of response to medical treatment. This approach is supported by the medical literature. However, in this case, the records indicate that testing was performed in October 2017, as a follow-up to dose intensification. At that point, the patient was feeling better and did not have clinical signs or symptoms to indicate non-response to her higher adalimumab dosing. The medical evidence does not support the services at issue in this clinical setting. Therefore, Prometheus Anser ADA testing performed on 10/10/17 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 60-year-old male enrollee has requested reimbursement for St. Jude Nanostim Leadless Pacemaker implant provided on 6/24/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.
, implantation of a permanent pacemaker was indicated given the patients history of syncope as well as documentation of a four second period of asystole. The implanting provider opined that given the patients active lifestyle he would be better served by a
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Upheld
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Experimental
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Summary Reviewer 2
A 60-year-old male enrollee has requested reimbursement for St. Jude Nanostim Leadless Pacemaker implant provided on 6/24/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found in this case, implantation of a permanent pacemaker was indicated given the patients history of syncope as well as documentation of a four second period of asystole. The implanting provider opined that given the patients active lifestyle he would be better served by a device that did not involve the implantation of transvenous leads. However, the St. Jude Nanostim Leadless Pacemaker is not U.S. Food and Drug Administration (FDA) approved. In addition, the current literature does not support a definitive long term benefit to health outcomes with the St. Jude Nanostim Leadless Pacemaker, and the long term safety and efficacy have not as yet been proven. All told, the St. Jude Nanostim Leadless Pacemaker implant provided on 6/24/15 was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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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A 50-year-old female enrollee has requested reimbursement for Afirma gene testing performed on 7/22/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition.
In this case the patient had a cytopathology result consistent with atypia of undetermined significance (AUS).
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Overturned
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Experimental
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Summary Reviewer 2
A 50-year-old female enrollee has requested reimbursement for Afirma gene testing performed on 7/22/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that The American Thyroid Association (ATA) guidelines state For nodules with [atypia of undetermined significance/follicular lesion of undetermined significance] AUS/FLUS cytology, after consideration of worrisome clinical and sonographic features, investigations such as repeat [fine needle aspiration] FNA or molecular testing may be used to supplement malignancy risk assessment in lieu of proceeding directly with a strategy of either surveillance or diagnostic surgery. Informed patient preference and feasibility should be considered in clinical decision-making. In this case the patient had a cytopathology result consistent with atypia of undetermined significance (AUS). Without this test, the patient would have required a second biopsy or surgery to clarify the diagnosis. Therefore the submission of the specimen to Afirma gene expression classifier was appropriate. The result was noted as suspicious which indicated a risk of malignancy of 40% in that nodule (Alexander, et al). The increased risk of malignancy justifies the decision to perform a thyroidectomy. With the size of the nodule the extension of the surgery can also be determined from the result. A benign result would have prevented an unnecessary surgery and its potential comorbidities. All told, the Afirma gene testing performed on 7/22/14 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 58-year-old female enrollee has requested reimbursement and prospective authorization and coverage for physical therapy services provided from 1/22/16 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 thoracic degenerative disc disease and facet dysfunction, lumbar foraminal and central stenosis.
patient has had extensive prior physical therapy and should be well versed in a home exercise program.
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Upheld
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Medical Necessity
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Summary Reviewer
A 58-year-old female enrollee has requested reimbursement and prospective authorization and coverage for physical therapy services provided from 1/22/16 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 thoracic degenerative disc disease and facet dysfunction, lumbar foraminal and central stenosis. The physician reviewer found that although a multidisciplinary approach to spine pain including physical therapy may be beneficial, the goal of therapy is to transition to an independent home exercise program without continued dependence on supervised therapy. Based on the available records, the additional requested physical therapy is not supported as a specific and effective treatment for this patients medical condition. The documentation does not indicate that prior extensive physical therapy has resulted in significant objective increase in overall function. Moreover, the services provided from 1/22/16 forward do not need to be only under the supervision of a therapist. The patient has had extensive prior physical therapy and should be well versed in a home exercise program. The patients expected rehabilitation potential is not significant in relation to the extent and duration of the physical therapy services. The specialized skill of a qualified therapist is not required to establish, design and/or deliver a maintenance program to maintain the patients current condition or to prevent or slow further deterioration. All told, the physical therapy services provided from 1/22/16 forward were not and are not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, 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 26-year-old male enrollee has requested reimbursement for inpatient hospital services provided from 4/12/18 through 4/17/18. 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.
features of a headache, including altered mental status, new neurologic deficit or associated seizures. He did not complain of a sudden-onset headache, and he had already been evaluated with multiple computed tomography (CT) scans of the head.
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Upheld
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Medical Necessity
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Summary Reviewer
A 26-year-old male enrollee has requested reimbursement for inpatient hospital services provided from 4/12/18 through 4/17/18. 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 in this case, the patient did not have high-risk features of a headache, including altered mental status, new neurologic deficit or associated seizures. He did not complain of a sudden-onset headache, and he had already been evaluated with multiple computed tomography (CT) scans of the head. The inpatient admission was not medically necessary. Inpatient care is necessary when the patients signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting, when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Therefore, inpatient hospital services provided from 4/12/18 through 4/17/18 were not medically necessary for the treatment of this patient.
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A 58-year-old female enrollee has requested reimbursement for autonomic nerve testing performed on 9/03/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 58-year-old female enrollee has requested reimbursement for autonomic nerve testing performed on 9/03/15. 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 that there is a lack of support for the services at issue in this clinical setting. Limb pain is a symptom, not a diagnosis. In this case, the medical records do not detail history or examination features that would suggest autonomic dysfunction. Details of electrodiagnostic tests are not available for review. Autonomic nerve testing has been determined to be useful in evaluation of syncope and of small fiber neuropathy. The medical literature in these circumstances is mixed at best, with a lack of high quality, randomized studies. In this patients case, there is not documentation in the submitted records which suggest need for autonomic testing. All told, autonomic nerve testing performed on 9/03/15 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.
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A 50-year-old female enrollee has requested authorization and coverage for minimally invasive sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.
In this case, the patient has been diagnosed with left sacroiliac joint dysfunction. She does have some physical examination findings that localize her symptoms to the left sacroiliac joint.
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Upheld
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Experimental
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Summary Reviewer 2
A 50-year-old female enrollee has requested authorization and coverage for minimally invasive sacroiliac joint fusion. 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 the submitted documentation fails to demonstrate the superior effectiveness of the requested services. While there is more convincing evidence to support arthrodesis for primary sacroiliac conditions with identified on imaging or with rheumatologic pathology such as trauma, tumor, spondyloarthropathy or infection, the evidence is much less clear when there is confounding degenerative pathology in the lumbar spine. In addition, the criteria for diagnosis of sacroiliac joint mediated pain remains unclear, and pain relief with injection is not recognized universally as the gold standard. In this case, the patient has been diagnosed with left sacroiliac joint dysfunction. She does have some physical examination findings that localize her symptoms to the left sacroiliac joint. However, there are no objective imaging or laboratory findings to indicate the presence of sacroiliac joint infection, tumor, sacroiliitis due to spondyloarthropathy or post-traumatic arthritis. The imaging studies do not demonstrate objective evidence of left-sided sacroiliac joint pathology but do demonstrate confounding multilevel lumbar degenerative changes. There is a lack of support for the requested services in this clinical setting. Therefore, the requested minimally invasive sacroiliac joint fusion is not likely to be more beneficial than any available standard therapy.
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A 63-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 6/11/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer 1
A 63-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 6/11/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the review of the submitted documentation and relevant literature supports the services at issue in this clinical setting. While there is a lack of long-term studies proving increased survival rates when tomosynthesis is used as a mammographic tool the addition of the technique to both screening and diagnostic mammography has gained worldwide popularity among providers due to the advantage the technique offers by eliminating overlapping dense glandular tissue from being confused with mass or architectural distortion which in turn could indicate neoplasm. The addition of the technique has reduced callbacks and increased detection of small cancers. Thus, the use of tomosynthesis in this case helped eliminate the concern of underlying malignancy. Therefore, the digital breast tomosynthesis performed on 6/11/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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 50-year-old female enrollee has requested reimbursement for breast tomosynthesis imaging performed on 2/10/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented for her annual breast examination.
In this particular patient, she has breasts that have been described as extremely dense.
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Overturned
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Experimental
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Summary Reviewer 3
A 50-year-old female enrollee has requested reimbursement for breast tomosynthesis imaging performed on 2/10/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented for her annual breast examination. 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 CT scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. In recent years, there have been several studies that have supported the use of breast tomosynthesis as a more accurate study than routine screening mammography. As Skaane concludes, in a study including 12,631 examinations, 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. In this particular patient, she has breasts that have been described as extremely dense. It is specifically those patients who have dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures better enables the possibility of demonstrating an otherwise occult tumor. In sum, breast tomosynthesis imaging performed on 2/10/17 was likely to have been more effective than the other methods for the evaluation of this patients medical condition. Based upon the information set forth above, the service at issue was likely to be more beneficial for the 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 polysomnography, sleep monitoring of a patient six years or older in a sleep laboratory with breathing equipment. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees chronic fatigue and sleep-related complaints.
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Upheld
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Medical Necessity
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Summary Reviewer
A 40-year-old female enrollee has requested authorization and coverage for polysomnography, sleep monitoring of a patient six years or older in a sleep laboratory with breathing equipment. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees chronic fatigue and sleep-related complaints. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested services. This patients clinical presentation is potentially suggestive of a sleep-related breathing disorder, specifically obstructive sleep apnea. Testing would be indicated to formally evaluate for obstructive sleep apnea. The clinical presentation was not otherwise suggestive of any other form of sleep disorder that is normally assessed via polysomnography. Based on the records, an attended sleep test is not the most appropriate supply or level of service which can be safely provided to the patient. The utility and validity of home sleep testing for the diagnosis of obstructive sleep apnea has been well-documented in the literature. Clinical guidelines, technology assessments, and review articles state that portable or home polysomnography may be used as an alternative to sleep-center polysomnography for the diagnosis of obstructive sleep apnea in patients with no contraindications, such as comorbid sleep disorders or major comorbid medical disorders. In this case, a home/unattended sleep test is the appropriate initial approach to evaluation of the patients complaints. If the home study is non-diagnostic for obstructive sleep apnea, then referral for attended testing could be considered. Thus, the requested polysomnography, sleep monitoring of a patient six years or older in a sleep laboratory with breathing equipment is not medically necessary for the evaluation for the evaluation of this patient. Therefore, the requested services are not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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The patient is a 63-year-old male with a history of metastatic urothelial cancer. The patient has been treated with surgery and cisplatin and gemcitabine and most recently on clinical trial with immunotherapy. The patient is requesting reimbursement for the FoundationOne gene testing performed on 5/4/16. The Health Insurer has denied this request as investigational. In this case, the patient has already progressed after first-line therapy.
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Overturned
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Experimental
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Summary Reviewer 2
The patient is a 63-year-old male with a history of metastatic urothelial cancer. The patient has been treated with surgery and cisplatin and gemcitabine and most recently on clinical trial with immunotherapy. The patient is requesting reimbursement for the FoundationOne gene testing performed on 5/4/16. The Health Insurer has denied this request as investigational. In this case, the patient has already progressed after first-line therapy. Molecular analysis of urothelial cancers has shown that 60% have alterations that can be targeted by drugs already approved for use in other indications or in clinical trials. Single patient benefit has been reported. Clinical trials are recommended by National Comprehensive Cancer Network (NCCN) guidelines. Testing with FoundationOne can help identify available clinical trials or drugs approved for other indications that may be available for compassionate use. For the reasons provided, FoundationOne gene testing performed on 5/4/16 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 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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An 80-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire airway stimulation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.
, he meets FDA criteria for the device. He has tried and failed CPAP treatment.
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Overturned
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Experimental
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Summary Reviewer 3
An 80-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire airway stimulation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the hypoglossal nerve stimulator is the most appropriate procedure and implant for the patient, considering potential benefits and harms. It is known to be effective based on scientific evidence in improving health outcomes. There are several studies that have looked at hypoglossal nerve stimulation as a way to improve upper airway stimulation and thereby treat obstructive sleep apnea. Strollo and colleagues published a study evaluating a multicenter, prospective, single-group cohort who had the device implanted. The authors concluded that aupper airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea.a There is long-term data that shows a reduction in the severity of obstructive sleep, good patient compliance, a reduction in sleepiness, and improvement in quality of life. In this patientas case, he meets FDA criteria for the device. He has tried and failed CPAP treatment. His sleep study does not show evidence of central sleep apnea. In addition, he does not have complete concentric collapse of the upper airway. Finally, his apnea-hypopnea index is within the appropriate range. Thus, hypoglossal nerve stimulation or Inspire airway stimulation is likely to be more beneficial than any available standard therapy.
| 1 |
A 47-year-old male enrollee has requested reimbursement for the magnetic resonance imaging (MRI) of the pelvis provided on 5/19/17. The Health Insurer has denied this request indicating that the service at issue was not medically necessary for evaluation of the enrollees prostate cancer.
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Overturned
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Medical Necessity
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Summary Reviewer
A 47-year-old male enrollee has requested reimbursement for the magnetic resonance imaging (MRI) of the pelvis provided on 5/19/17. The Health Insurer has denied this request indicating that the service at issue was not medically necessary for evaluation of the enrollees prostate cancer. The physician reviewer found that repeat imaging in this clinical setting to evaluate the patient for a change in the size of the tumor focus as well as the capsule and surrounding structures is state of the art medicine. Even though the patients PSA has remained stable the patient has a history of proven malignancy even in the face of a low PSA level. Currently, prostate MRI using a 3 Tesla magnet and restriction spectrum imaging (RSI) or diffusion weighted imaging is the most sensitive way to image the prostate and the surrounding anatomy. Based on the findings on this follow-up MRI, if there had been a change in the size of the tumor or if another focus of restricted diffusion was visualized, then the patient would likely have been referred for surgery. Given this support, an MRI of the prostate was indicated and MRI has been proven to be the most reliable means for further evaluation in this clinical setting. Accordingly, the MRI of the pelvis provided on 5/19/17 was medically necessary. For the reasons discussed, the service at issue was medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 10/29/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for purposes of the enrollees breast cancer screening.
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Overturned
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Experimental
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Summary Reviewer 1
A 60-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 10/29/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for purposes of the enrollees breast cancer screening. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues state that integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. All told, breast tomosynthesis performed on 10/29/15 was likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were 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 39-year-old male enrollee has requested authorization and coverage for Staxyn, eight tablets per month. The Health Insurer has denied this request and reported that the requested medication quantity is not medically necessary for treatment of the enrollees erectile dysfunction. A review of the record indicates that the enrollee has been diagnosed with erectile dysfunction. Per the submitted documentation, the enrollee was prescribed Staxyn for treatment of this condition. The enrollee reported that his provider has recommended eight tablets per month, and the Health Insurer has only covered three tablets per month. The Health Insurer indicated that the requested medication quantity is not medically
for treatment of the enrollees medical condition. Therefore, the Health Insurer has denied coverage for the requested medication quantity.
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Overturned
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Medical Necessity
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Summary Reviewer
A 39-year-old male enrollee has requested authorization and coverage for Staxyn, eight tablets per month. The Health Insurer has denied this request and reported that the requested medication quantity is not medically necessary for treatment of the enrollees erectile dysfunction. A review of the record indicates that the enrollee has been diagnosed with erectile dysfunction. Per the submitted documentation, the enrollee was prescribed Staxyn for treatment of this condition. The enrollee reported that his provider has recommended eight tablets per month, and the Health Insurer has only covered three tablets per month. The Health Insurer indicated that the requested medication quantity is not medically necessary for treatment of the enrollees medical condition. Therefore, the Health Insurer has denied coverage for the requested medication quantity. At issue is whether the requested medication quantity is medically necessary for treatment of the enrollees medical condition.The Health Insurers quantity limit of the requested medication is three tablets per month. I have determined that the requested medication quantity is medically necessary for treatment of the patients medical condition. Therefore, the Health Insurers denial should be overturned
| 1 |
The parent of a 16-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 12/13/13. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees ulcerative colitis.
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a 16-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 12/13/13. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees ulcerative colitis.The physician reviewer found the use of Anser IFX testing was appropriate in this patient case, to determine whether his clinical worsening was due to inadequate infliximab dosing, neutralization of the medication by antibodies, or loss of response to the medication. The use of infliximab levels and antibodies is supported by the medical literature. The studies indicate that measurement of infliximab levels and anti-infliximab (anti-chimeric) antibodies produces actionable data (Afif et al; and Yanai and Hanauer). Change of dose or drug based on these results improves response to treatment, as measured by clinical response. The study by Hoekman and colleagues demonstrates that lower infliximab troughs are associated with elevated markers of mucosal inflammation in children. The studies cited above support the use of infliximab levels and antibody measurements in the setting of inadequate clinical response to treatment, as well as for monitoring effectiveness of dose escalation. The alternative is to sequentially increase dose and decrease dosing frequency of infliximab, then empirically change to another medication, typically adalimumab, if lack of response persists. This clinical approach can be lengthy and can prolong a patients symptoms as well as the likelihood of an intercurrent hospital admission. Therefore, Prometheus Anser IFX diagnostic testing performed on 12/13/13 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 57-year-old male enrollee has requested authorization and coverage for the Inspire hypoglossal nerve stimulation therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea.
this patient has severe sleep apnea with a low oxygen nadir. He has been treated with all available standard therapies including multilevel surgery, CPAP, BiPAP, and oral appliances. Evaluation with a sleep endoscopy showed he has pathology in the area which would
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Overturned
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Experimental
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Summary Reviewer 2
A 57-year-old male enrollee has requested authorization and coverage for the Inspire hypoglossal nerve stimulation therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that this patient has severe sleep apnea with a low oxygen nadir. He has been treated with all available standard therapies including multilevel surgery, CPAP, BiPAP, and oral appliances. Evaluation with a sleep endoscopy showed he has pathology in the area which would most benefit from hypoglossal stimulation. The hypoglossal stimulation device for the treatment of obstructive sleep apnea has been proven to be safe, and effective in clinical studies (Certal, et al; Woodson, et al). This patient is a good candidate for the recommended treatment and he has exhausted all standard alternatives. Thus, the requested Inspire hypoglossal nerve stimulation therapy is likely to be more beneficial for treatment of the patients medical condition than any standard therapy. Based upon the information set forth above, I have determined 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.
| 1 |
patient is a 57-year-old female with a history of chronic neck pain with right-sided radicular manifestations in the hand with intrinsic atrophy. Electromyography and nerve conduction studies
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 57-year-old female with a history of chronic neck pain with right-sided radicular manifestations in the hand with intrinsic atrophy. Electromyography and nerve conduction studies have revealed C7 radiculopathy consistent with the clinical picture. The physician reviewer found that Cervical disc arthroplasty has become an acceptable and better procedure than anterior cervical discectomy and fusion for a significant patient population with cervical radiculopathy secondary to degenerative changes in the cervical spine, as in this case. Two-level total disc replacement with the U.S. Food and Drug Administration (FDA) approved Mobi-C device demonstrated excellent long-term results with lesser incidence of adjacent level disease, less pain, lesser incidence of revision surgery, and better motion compared to anterior cervical discectomy and fusion for treatment of symptomatic cervical two-level degenerative disc disease. Per the literature, this procedure is safe and effective. A hybrid construct is another option with a fusion at C7-T1 and total disc replacement at C6-7. There is sufficient support for the requested services in this clinical setting. Therefore, the requested cervical spine surgery is medically necessary for the treatment of this patient.
| 1 |
A 58-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 2/10/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 58-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 2/10/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the American College of Radiology (ACR) has urged tomosynthesis be removed from the investigational category due to the advantages it brings to radiologists interpreting mammograms especially in patients with heterogeneously dense tissue such as the patient in this case. Tomosynthesis allows radiologists to separate dense glandular elements form underlying mass and architectural distortion resulting in a decrease in callbacks and increase in detection of small cancers. Thus, the addition of tomosynthesis to the usual two-dimensional imaging protocol was likely of greater benefit to this patient than had her exam been done with two-dimensional imaging alone. 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.
| 0 |
The parent of a 17-year-old female enrollee has requested reimbursement for surgery performed on 6/22/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for treatment of the enrollees enlarged labia. A review of the record indicates that the enrollee presented to her provider on 4/27/17. The enrollee reported enlarged labia which caused her to wear panty liners daily so that the bulge would not be noticeable through her underwear. Due to pad usage, she developed chronic irritation with intermittent vaginal discharge. On 6/22/17, bilateral labia minora reduction was performed. The Health Insurer indicates that the services at issue were not medically necessary. Therefore, the Health Insurer has denied reimbursement for the services at issue.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 17-year-old female enrollee has requested reimbursement for surgery performed on 6/22/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for treatment of the enrollees enlarged labia. A review of the record indicates that the enrollee presented to her provider on 4/27/17. The enrollee reported enlarged labia which caused her to wear panty liners daily so that the bulge would not be noticeable through her underwear. Due to pad usage, she developed chronic irritation with intermittent vaginal discharge. On 6/22/17, bilateral labia minora reduction was performed. The Health Insurer indicates that the services at issue were not medically necessary. Therefore, the Health Insurer has denied reimbursement for the services at issue. At issue is whether the services at issue were medically necessary for treatment of the enrollees medical condition. I have determined that the services at issue were not medically necessary for treatment of the patients medical condition. Therefore, the Health Insurers denial should be upheld.
| 1 |
A 33-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation (64568 and 0466T). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
This patient has obstructive sleep apnea, and he is status post septoplasty. Drug-induced sleep endoscopy showed no concentric collapse at velum. The patient has not been able to tolerate continuous positive airway pressure (CPAP) therapy. The Inspi
This patient is a candidate for the Inspire device as he has failed CPAP therapy, and his body mass index and apnea-hypopnea index
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Overturned
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Experimental
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Summary Reviewer 1
A 33-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation (64568 and 0466T). 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. This patient has obstructive sleep apnea, and he is status post septoplasty. Drug-induced sleep endoscopy showed no concentric collapse at velum. The patient has not been able to tolerate continuous positive airway pressure (CPAP) therapy. The Inspire device has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of obstructive sleep apnea. This patient is a candidate for the Inspire device as he has failed CPAP therapy, and his body mass index and apnea-hypopnea index are within the range of pivotal FDA studies. Therefore, the requested hypoglossal nerve stimulation (64568 and 0466T) is likely to be more effective than other treatment options.
| 1 |
A 53-year-old male enrollee has requested authorization and coverage for methadone 10 mg tablets, 566 pills per 30 days. The Health Insurer has denied this request indicating that the requested medication quantity is not medically necessary for treatment of the enrollees pain.
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Upheld
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Medical Necessity
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Summary Reviewer
A 53-year-old male enrollee has requested authorization and coverage for methadone 10 mg tablets, 566 pills per 30 days. The Health Insurer has denied this request indicating that the requested medication quantity is not medically necessary for treatment of the enrollees pain. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication quantity. High-dose methadone is not recommended for chronic non-malignant pain. Clinical practice guidelines specifically identify the markedly increased risk of overdose when morphine equivalent dose exceeds 60 mg per day, as in this patients case. Due to the history of obesity, he is also at increased risk of obstructive sleep apnea, and this risk is amplified by high-dose opiates. The records do not document other approaches to pain management. Documentation of spinal cord stimulator evaluation, weight loss counseling or alternative medication was not provided. Clinical guidelines support tapering the patient and providing alternative pain management methods. Thus, methadone 10 mg tablets, 566 pills per 30 days are not medically necessary for the treatment of this patient. Therefore, the requested medication quantity is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 27-year-old male enrollee has requested authorization and coverage for venlafaxine extended release (ER) 450 mg per day. The Health Insurer has denied this request indicating that the requested dosage is not medically necessary for treatment of the enrollees generalized anxiety disorder.
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Overturned
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Medical Necessity
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Summary Reviewer
A 27-year-old male enrollee has requested authorization and coverage for venlafaxine extended release (ER) 450 mg per day. The Health Insurer has denied this request indicating that the requested dosage is not medically necessary for treatment of the enrollees generalized anxiety disorder. The physician reviewer found that although fairly uncommon, the medical literature supports venlafaxine doses of 450 mg daily. According to the American Psychiatric Association (APA), venlafaxine exhibits linear kinetics over a dosage range of 75-450 mg/day. Further, the APA recognize that a large amount of data from randomized controlled clinical trials suggest that patients who do not respond to lower dosages often benefit from dosage increases. The presence of obsessive compulsive disorder (OCD), which typically necessitates supra-therapeutic dosing of serotonergic enhancing medication in clinical practice, further supports the requested treatment. Indeed, the APA clinical practice guideline referenced a study that demonstrated sustained clinical response for previous non-responders, without tolerability issues, of venlafaxine doses up to 450 mg daily. Considering that this patients medical records demonstrate clinical stability on the current regimen, physician recommendation, endorsement from the APA and the peer-reviewed literature base, high-dose venlafaxine therapy represents a safe, appropriate treatment consistent with good medical practice. Continuation of the therapy would be reasonably expected to maintain the patients wellness and prevent a more serious episode of illness. As such, the requested venlafaxine extended release 450 mg per day is medically necessary for treatment of the patients behavioral health condition. Based on the foregoing, the requested dosage is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The parent of a 16-year-old female enrollee has requested reimbursement for autonomic testing
performed on 8/19/20. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition.
This
patient has experienced repeated episodes of near syncope, some of which are associated with
injury. She describes that the episodes are often positional.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a 16-year-old female enrollee has requested reimbursement for autonomic testing
performed on 8/19/20. 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 sufficient support for the services at issue in this clinical setting. This
patient has experienced repeated episodes of near syncope, some of which are associated with
injury. She describes that the episodes are often positional. Use of autonomic nervous system
testing is appropriate when signs and/or symptoms of autonomic dysfunction are present, a
definitive diagnosis cannot be made from clinical examination and routine laboratory testing
alone, and diagnosis of the suspected autonomic disorder will lead to a change in management
or will eliminate the need for further testing. The American Academy of Neurology Model
Coverage Policy noted, Autonomic testing may not be able to differentiate between similar
disorders that both cause autonomic dysfunction, but can quantify the severity of autonomic
dysfunction, in other cases exclude autonomic dysfunction, and thereby lead to specific
recommendations for treatment. Low and colleagues noted, Modern autonomic function tests
can non-invasively evaluate the severity and distribution of autonomic failure. They have
sufficient sensitivity to detect even subclinical dysautonomia. Standard laboratory testing
evaluates cardiovagal, sudomotor and adrenergic autonomic functions. Cardiovagal function is
typically evaluated by testing heart rate response to deep breathing at a defined rate and to the
Valsalva maneuver. Sudomotor function can be evaluated with the quantitative sudomotor axon
reflex test and the thermoregulatory sweat test. Adrenergic function is evaluated by the blood
pressure and heart rate responses to the Valsalva maneuver and to head-up tilt. Tests are useful
in defining the presence of autonomic failure, their natural history, and response to treatment.
They can also define patterns of dysautonomia that are useful in helping the clinician diagnose
certain autonomic conditions. For example, the tests are useful in the diagnosis of the autonomic
neuropathies and distal small fiber neuropathy. The American Academy of Neurology stresses
the importance of being able to distinguish benign from life-threatening forms of autonomic
nervous system dysfunction by the use of autonomic nervous system testing. Therefore,
autonomic testing performed on 8/19/20 was likely to have been more beneficial than any
available standard therapy.
| 1 |
patient is a 61-year-old male with persistent, symptomatic atrial fibrillation with multiple
hospital visits for chemical cardioversion. The patient has requested authorization and coverage
for hybrid convergent ablation treatment of atrial fibrillation (CPT 33266).
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 61-year-old male with persistent, symptomatic atrial fibrillation with multiple
hospital visits for chemical cardioversion. The patient has requested authorization and coverage
for hybrid convergent ablation treatment of atrial fibrillation (CPT 33266). The physician reviewer
found that the hybrid convergent procedure has superior effectiveness compared with
endocardial-only ablation in patients with advanced atrial fibrillation. This was demonstrated in
the CONVERGE trial, a multicenter, randomized clinical trial which also showed a significantly
higher number of patients in the hybrid convergent arm remaining free from cardioversion at 18
months follow-up. This was also associated with an acceptable safety profile. The cumulative
experience with the convergent procedure is now greater than 10,000 patients to date and has
an established position in managing atrial fibrillation. Therefore, hybrid convergent ablation
treatment of atrial fibrillation (CPT 33266) is medically necessary for treatment of the patients
medical condition.
| 1 |
A 41-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 1/17/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 41-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 1/17/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of
invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is very novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Therefore, DecisionDx-Melanoma testing performed on 1/17/20 was not likely to have been more beneficial than other methods of evaluating this patient.
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The parent of a 16-year-old male enrollee has requested reimbursement for mental health outpatient services provided from 11/25/15 through 5/12/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder (ADHD).
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 16-year-old male enrollee has requested reimbursement for mental health outpatient services provided from 11/25/15 through 5/12/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder (ADHD). The physician reviewer found that reviewing therapy progress notes including those from 11/25/15, 12/17/15 and 3/17/16 it was consistently noted that the patient had restlessness, depression, but there was no documentation of any evidence that would warrant extended outpatient sessions. There was no indication that the patient was in crisis or decompensating, or that he required specialized services that would require extended sessions. Overall, the records provided for review suggest this patient could have been reasonably and adequately treated with less intrusive, less invasive level of care, such as regular outpatient therapy sessions. Accordingly, the mental health outpatient services provided from 11/25/15 through 5/12/16 were not medically necessary for treatment of this patients medical condition. Based on the records provided, the services at issue were 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 gene testing (breast cancer index test) performed on 7/16/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 63-year-old female enrollee has requested reimbursement for gene testing (breast cancer index test) performed on 7/16/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the BCI is a combination of two profiles, the HOXB13-to-IL17BR expression ratio (H:I ratio) and the Molecular Grade Index (MGI). Compared with clinical prognostic factors, such as age, tumor size, tumor grade, and lymph node status, the H:I ratio was significantly and independently correlated with outcome. Subsequent studies have validated the BCI as an accurate predictor of endocrine responsiveness among patients with estrogen receptor positive breast cancer, with one case-control study suggesting it may identify those who would benefit from extended endocrine therapy. The American Society of Clinical Oncology (ASCO) supports use of the BCI. The National Comprehensive Cancer Network guidelines noted, For patients with T1 and T2 hormone receptor-positive, HER2-negative, and lymph node-negative tumors, a BCI in the low-risk range, regardless of T size, places the tumor into the same prognostic category as T1aT1b, N0, M0. Results of a secondary analysis of the aTTom trial demonstrated that in patients with hormone-receptor positive, node-positive breast cancer, patients with a high BCI (HOXB13/IL17BR) (H/I) derived significant benefit from extending tamoxifen therapy to 10 years versus five years. In contrast, BCI (H/I) low patients derived no benefit from extended adjuvant therapy. This patient fits in the latter category, and the results may allow her to come off of endocrine therapy, for which she experiencing side effects. The medical evidence supports the services at issue in this clinical setting. Therefore, gene testing (BCI test) performed on 7/16/18 was medically necessary for the evaluation of this patient.
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A 48-year-old female enrollee has requested authorization and coverage for implantation of Strattice. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees abdominal hernia.
, the patient has failed standard therapy for correction of her complex abdominal hernia. She has failed primary repair with synthetic mesh, as the mesh had become infected and had to be removed. This patient has evidence of a symptomatic, recurrent, left lower abdominal hernia. She has a history of severe trauma and multiple reconstructive procedures of her abdomen. She has noted to have failed previous mesh placement, as it had become infected and had to be removed. Currently, she is symptomatic from her hernia with chronic pain, treated with an abdominal binder and chronic opioid use.
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Overturned
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Experimental
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Summary Reviewer 1
A 48-year-old female enrollee has requested authorization and coverage for implantation of Strattice. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees abdominal hernia. The physician reviewer found that there is support in the literature for the efficacy of the requested services in this clinical setting. Based on the overall documentation provided for review, the patient has failed standard therapy for correction of her complex abdominal hernia. She has failed primary repair with synthetic mesh, as the mesh had become infected and had to be removed. This patient has evidence of a symptomatic, recurrent, left lower abdominal hernia. She has a history of severe trauma and multiple reconstructive procedures of her abdomen. She has noted to have failed previous mesh placement, as it had become infected and had to be removed. Currently, she is symptomatic from her hernia with chronic pain, treated with an abdominal binder and chronic opioid use. The requested Strattice (porcine biologic mesh) is used to reinforce the abdominal reconstruction provided by autologous tissue. Strattice is a bioprosthetic porcine mesh. The medical literature indicates that bioprosthetic materials are preferred over synthetic materials for use in contaminated fields and should be strongly considered when the defect has bacterial contamination. Patel and colleagues noted, Strattice is an effective adjunct to AWR (abdominal wall reconstruction) when used as reinforcement during CS (component separation) for a wide variety of indications. Complication rates remain low in complex patients. In addition, Strattice appears to add durability to midline reconstructions with no recurrences during the follow-up period. In summary, this patient has exhausted standard therapy and Strattice has been shown to provide benefit in abdominal wall reconstruction. As such, implantation of Strattice is likely to be superior to the standard options available for treatment of this patients medical condition.Therefore for the reasons stated 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.
| 1 |
A 20-year-old female enrollee has requested reimbursement for the wilderness therapy program received from 5/22/15 through 8/3/15. The Health Plan has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 20-year-old female enrollee has requested reimbursement for the wilderness therapy program received from 5/22/15 through 8/3/15. The Health Plan 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 lack of support in the literature for the medical necessity of the services at issue in this clinical setting. In an article by Widmer and colleagues, the authors noted that while some studies report benefits of wilderness therapy, caution should be exercised in the interpretation of these results. In order to establish its efficacy, a multi-centered, highly-powered, randomized controlled trial would need to be performed. Currently, there are not enough studies to indicate that wilderness therapy is effective in the treatment of depression and anxiety over standard therapies. In addition, from the records provided, there was a lack of oversight by a child and adolescent psychiatrist, and there were no nursing staff to properly administer medications and monitor the patients. Accordingly, based on the medical literature, wilderness therapy received from 5/22/15 through 8/3/15 did not meet the standard of care for the treatment of depression, anxiety, and substance use. As such, the wilderness therapy program received from 5/22/15 through 8/3/15 was not medically necessary for treatment of this patients medical condition. Therefore, based on the information noted above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
The patient is a 62-year-old male with a progressive neurodegenerative disease with ataxia, dysarthria, fatigue and cognitive dysfunction. The patient had an abnormal magnetic resonance imaging (MRI) in the past with localized atrophy. His provider suspected the diagnosis of multisystem atrophy versus spinocerebellar atrophy and recommended dopamine transporter single photon emission computed tomography (DaT SPECT). The patient has requested reimbursement for DaT SPECT scan of the brain performed on 9/23/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.
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Upheld
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Experimental
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Summary Reviewer 2
The patient is a 62-year-old male with a progressive neurodegenerative disease with ataxia, dysarthria, fatigue and cognitive dysfunction. The patient had an abnormal magnetic resonance imaging (MRI) in the past with localized atrophy. His provider suspected the diagnosis of multisystem atrophy versus spinocerebellar atrophy and recommended dopamine transporter single photon emission computed tomography (DaT SPECT). The patient has requested reimbursement for DaT SPECT scan of the brain performed on 9/23/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. While a DaT SPECT study is not indicated for all patients with degenerative diseases, it has been shown to be useful in cases where the diagnosis of Parkinsons disease (or a Parkinson plus syndrome such as multisystem atrophy) versus another non-dopaminergic degenerative disorders (such as spinocerebellar atrophy) is being considered. These diseases can be challenging to differentiate based only on clinical grounds. In this particular case, the DaT SPECT scan provided definitive information. It is imperative to provide a definitive diagnosis as treatment for multisystem atrophy, Parkinsons disease, and spinocerebellar atrophy are quite different and a trial of an unnecessary therapy would place the patient at risk of significant side effects. There is some support in the medical literature demonstrating the use of this study in differentiating patients with movement disorders. Thus, DaT SPECT scan of the brain performed on 9/23/16 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 62-year-old female with metastatic urothelial cancer. She presented with right hydronephrosis and an irregular bladder wall. This was bladder cancer at stage T4. She underwent transurethral resection of bladder tumor and was treated with gemcitabine and cisplatin. By June 2017, she had a right inguinal lymph node that had metastatic urothelial cancer. A staging computed tomography (CT) in July 2017 showed extensive abdominal lymphadenopathy with evidence of diffuse metastatic disease. A tumor sample was submitted to FoundationOne for mutational testing. The patient has requested reimbursement for the FoundationOne gene test provided on 8/15/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational.
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Upheld
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Experimental
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Summary Reviewer 3
The patient is a 62-year-old female with metastatic urothelial cancer. She presented with right hydronephrosis and an irregular bladder wall. This was bladder cancer at stage T4. She underwent transurethral resection of bladder tumor and was treated with gemcitabine and cisplatin. By June 2017, she had a right inguinal lymph node that had metastatic urothelial cancer. A staging computed tomography (CT) in July 2017 showed extensive abdominal lymphadenopathy with evidence of diffuse metastatic disease. A tumor sample was submitted to FoundationOne for mutational testing. The patient has requested reimbursement for the FoundationOne gene test provided on 8/15/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. One standard regimen for advanced bladder cancer is methotrexate, vincristine, doxorubicin, and cisplatin (MVAC) (Sternberg, et al). Regimens with fewer drugs have been compared head-to-head with MVAC but have not performed as well in terms of survival advantage but have demonstrated reasonable response rates (Mead, et al; Hillcoat, et al). Von Hoff and colleagues reported on a study of 86 patients where the progression-free survival (PFS) on regimen selected by molecular profiling was compared to PFS on the last chemotherapy regimen. The authors noted that the regimen selected by molecular profiling offered a 27% survival advantage. This trial has very significant results for patients with stage IV tumors. Given this support, the FoundationOne gene test performed on 8/15/16 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 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 38-year-old female enrollee has requested authorization and coverage for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee. The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees osteochondral defect.
. In this case, the patient has undergone multiple surgeries on the cystic osteochondral lesion of the talus with persistent severe pain.
There is imaging evidence of an osteochondral defect of the medial talar dome, measuring 9 x 9 x 8 mm.
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Overturned
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Experimental
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Summary Reviewer 1
A 38-year-old female enrollee has requested authorization and coverage for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee. The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees osteochondral defect. The physician reviewer found the peer-reviewed literature demonstrates that autologous chondrocyte implantation of the talus yields improvement in all parameters tested with enduring long-term results in patients who have failed previous surgery for osteochondral lesions of the talus. In this case, the patient has undergone multiple surgeries on the cystic osteochondral lesion of the talus with persistent severe pain. Significant limitation is documented in activities of daily living, work activities, and recreational pursuits. Detailed evidence of long-term reasonable and/or comprehensive non-operative and operative treatment and failure has been submitted. There is imaging evidence of an osteochondral defect of the medial talar dome, measuring 9 x 9 x 8 mm. Autologous chondrocyte implantation of the talus is supported by a significant volume of literature for patients who have failed previous surgery for osteochondral lesions of the talus. Therefore, the request for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee, is 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.
| 1 |
A 59-year-old female enrollee has requested reimbursement for high dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, for dates of service 2/07/19, 2/09/18, 2/12/19, 2/14/19, 2/19/18, 2/21/18, 2/26/18, 2/28/18 and 3/05/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
. The records document squamous cell carcinoma of the skin.
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Upheld
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Experimental
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Summary Reviewer 1
A 59-year-old female enrollee has requested reimbursement for high dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, for dates of service 2/07/19, 2/09/18, 2/12/19, 2/14/19, 2/19/18, 2/21/18, 2/26/18, 2/28/18 and 3/05/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the services at issue in this patients case. The records document squamous cell carcinoma of the skin. Per the most current American Brachytherapy Society Consensus Statement: At this time, there are growing data with respect to electronic brachytherapy and non-melanomatous skin cancer; however, there is a lack of comparative data to traditional treatments, limited data with long-term follow up, and a need for younger patients in studies before generalizing recommendations. Although data can be extrapolated from orthovoltage experiences with non-melanomatous skin cancer, in light of the large numbers of patients diagnosed with non-melanomatous skin cancer, prospective studies with larger numbers of patients undergoing electronic brachytherapy should be performed. National Comprehensive Cancer Network guidelines support these recommendations. Therefore, the superior efficacy of high dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, for dates of service 2/07/18, 2/09/18, 2/12/18, 2/14/18, 2/19/18, 2/21/18, 2/26/18, 2/28/18 and 3/05/18 has not been established.
| 1 |
A 37-year-old male enrollee has requested reimbursement for an ultrasound provided on 4/05/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 37-year-old male enrollee has requested reimbursement for an ultrasound provided on 4/05/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that liver fibrosis is an important prognostic factor in patients with chronic hepatitis B, and assessment of the stage of liver fibrosis is important in management. Ultrasound with elastography offers a noninvasive alternative to biopsy for the assessment of liver fibrosis, with comparable diagnostic accuracy, but also can identify patients with subclinical cirrhosis who are at increased risk of developing hepatocellular carcinoma, even when cirrhosis is not clinically apparent. Elastography is a noninvasive alternative to liver biopsy for this assessment, and avoids the invasiveness, risk of complications, and sampling error associated with liver biopsy. The American Gastroenterological Association (AGA) Institute guideline for elastography states, In patients with chronic hepatitis B, the AGA suggests vibration-controlled transient elastography rather than other nonproprietary noninvasive serum tests to detect cirrhosis. By avoiding the complications of liver biopsy, and allowing for appropriate management of chronic hepatitis B (which differs depending on whether cirrhosis is present), elastography can result in improved health outcomes. For these reasons, ultrasound with elastography was medically indicated for the management of this patients chronic hepatitis B. Therefore, the ultrasound with elastography performed on 4/05/18 was medically necessary for the evaluation of this patient.
| 0 |
A 49-year-old female enrollee has requested reimbursement for a digital breast tomosynthesis that was performed on 3/22/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for the enrollees breast examination
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Overturned
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Experimental
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Summary Reviewer 2
A 49-year-old female enrollee has requested reimbursement for a digital breast tomosynthesis that was performed on 3/22/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for the enrollees breast examination The physician reviewer found there is evidenced base 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 her 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
| 1 |
A 22-year-old female enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing 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 Crohns disease.
this case, Anser ADA was ordered to determine the etiology for possible loss of response and reaction to Humira, and to direct the management of the patients Crohns disease.
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Upheld
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Experimental
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Summary Reviewer 2
A 22-year-old female enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing 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 Crohns disease. The physician reviewer found the use of Anser ADA has not been clinically proven to improve patient clinical outcomes, and has not definitively demonstrated clinical utility. In this case, Anser ADA was ordered to determine the etiology for possible loss of response and reaction to Humira, and to direct the management of the patients Crohns disease. The effectiveness of Anser ADA compared with conventional courses of action remains unproven. Patients being treated with adalimumab may experience loss of response. However, loss of response can be due to multiple factors, and the appropriate method for determination of the cause for loss of response is not clear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature. These small studies at best demonstrated correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect. Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. Therefore, Anser ADA testing performed on 1/16/15 was not likely to have been superior over other modalities for 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 |
The parent of a five-year-old male enrollee has requested reimbursement for the comparative genomic hybridization (CGH) FirstStep DX Plus testing performed on 10/15/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a five-year-old male enrollee has requested reimbursement for the comparative genomic hybridization (CGH) FirstStep DX Plus testing performed on 10/15/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that according to Slavotinek, Array comparative genomic hybridization (array CGH) has revolutionized the cytogenetic testing available for patients with learning disabilities who have chromosomal phenotypes with dysmorphic features and multiple anomalies. Screening large patient cohorts with mental retardation by array CGH has recently lead to the characterization of many novel microdeletion and microduplication syndromes, initially according to the shared cytogenetic aberrations, with secondary characterization of the corresponding phenotypes. The author further states that, it is clear that array CGH has heralded an unparalleled era of discovery for clinical cytogenetics. Data have now emerged showing that actionable findings from chromosomal microarray justify its use. Given the support in the peer-reviewed literature, the comparative genomic hybridization (CGH) FirstStep DX Plus testing performed on 10/15/15 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 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.
| 0 |
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