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1
A 59-year-old female enrollee has requested reimbursement for the single photon emission computed tomography (SPECT) scan performed on 2/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees rigidity, lack of response to Sinemet trial, with suspected Parkinsons disease.
Overturned
Experimental
Summary Reviewer 3 A 59-year-old female enrollee has requested reimbursement for the single photon emission computed tomography (SPECT) scan performed on 2/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees rigidity, lack of response to Sinemet trial, with suspected Parkinsons disease. The physician reviewer found that in the current medical literature, DAT SPECT imaging of the brain has been shown to be helpful in the diagnosis of suspected Parkinsons disease. The agent used is a specific isotope which localizes areas of differential function (Djang, et al). In this patients case, the use of the DAT SPECT scan assisted in the diagnosis of Parkinsons disease, which in turn prompted treatment. All told, the peer-reviewed medical literature supports the clinical utility of the SPECT scan at issue as useful and likely to be more beneficial in evaluating and treating this patient than any available modality. Based upon the information set forth above, I have determined 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 60-year-old female enrollee has requested reimbursement for genomic analysis performed on 6/15/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ovarian cancer.
Overturned
Experimental
Summary Reviewer 1 A 60-year-old female enrollee has requested reimbursement for genomic analysis performed on 6/15/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ovarian cancer. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. In order to demonstrate the clinical utility of panel testing for somatic genomic alterations, prospective randomized clinical trials are needed that compare the strategy of targeted treatment based on panel results with the standard of care. The available literature on clinical utility consists of a small number of uncontrolled studies and nonrandomized controlled trials that use imperfect comparators. This evidence is not sufficient to make conclusions on clinical utility. In addition, there is potential for harm if ineffective therapy is given based on test results. Therefore, genomic analysis performed on 6/15/17 was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
0
The parent of a 13-year-old male enrollee has requested authorization and coverage for Privigen. 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 a history of PANS and current documented autoimmune encephalitis. He has been under the care of numerous specialists, with multiple hospitalizations, psychiatric admissions, and almost two months at a long-term care facility. Despite treatments with steroid burst, psychotherapy, and numerous psychoactive medications, he continued to have severe symptoms, including oppressive suicidal ideation. Only after beginning treatment with
Overturned
Experimental
Summary Reviewer 1 The parent of a 13-year-old male enrollee has requested authorization and coverage for Privigen. 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 a history of PANS and current documented autoimmune encephalitis. He has been under the care of numerous specialists, with multiple hospitalizations, psychiatric admissions, and almost two months at a long-term care facility. Despite treatments with steroid burst, psychotherapy, and numerous psychoactive medications, he continued to have severe symptoms, including oppressive suicidal ideation. Only after beginning treatment with appropriately dosed IVIG have the neuropsychiatric symptoms started to recede. Therefore, Privigen is likely to be more beneficial than other available treatment options.
1
A 32-year-old male enrollee has requested reimbursement for partial hospitalization services from 1/20/17 through 2/10/17. 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 had no withdrawal symptoms. He showed no evidence of being a danger to self or others. He was cognitively intact and there were no . He was medically and psychiatrically stable. The patient noted that he had not attempted treatment at lower levels of care. . This patient was motivated and engaged in the recovery process. He had support systems in place. He could have received treatment at a lower level of care.
Upheld
Medical Necessity
Summary Reviewer A 32-year-old male enrollee has requested reimbursement for partial hospitalization services from 1/20/17 through 2/10/17. 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 the documentation provided does not support the medical necessity for the services at issue in this clinical setting. The patient had no withdrawal symptoms. He showed no evidence of being a danger to self or others. He was cognitively intact and there were no emotional, behavioral, cognitive, or impulsive symptoms that would warrant this level of care. He was medically and psychiatrically stable. The patient noted that he had not attempted treatment at lower levels of care. There was no evidence that treatment at a lower level of care would cause relapse or decompensation. This patient was motivated and engaged in the recovery process. He had support systems in place. He could have received treatment at a lower level of care. As such, the PHP services for substance use disorders from 1/20/17 through 2/10/17 were not medically necessary for treatment of this patient. Therefore, for the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
1
The parent of a six-year-old male enrollee has requested authorization and coverage for Saizen 8.8 mg click easy cartridge. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition . This patient was born small for gestational age with lack of catch-up growth, growth hormone abnormalities (indicative of deficiency without stimulation testing), and small pituitary gland on MRI. He was treated successfully in the past, with significant improvement in growth velocity, but the medication was discontinued prematurely and his height is
Overturned
Experimental
Summary Reviewer 1 The parent of a six-year-old male enrollee has requested authorization and coverage for Saizen 8.8 mg click easy cartridge. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition The physician reviewer found there is sufficient support for the requested medication in this clinical setting. This patient was born small for gestational age with lack of catch-up growth, growth hormone abnormalities (indicative of deficiency without stimulation testing), and small pituitary gland on MRI. He was treated successfully in the past, with significant improvement in growth velocity, but the medication was discontinued prematurely and his height is now more than two standard deviations below the mean. There are two ways to determine duration of therapy: administration of growth hormone when near adult height is achieved, or discontinuation of therapy when the height is in the normal adult range, less than two standard deviations from the mean. Either course of action is appropriate. All told, Saizen 8.8 mg click easy cartridge is likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 38-year-old male enrollee has requested reimbursement for genetic testing performed on 5/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. This patients initial biopsy was suspicious for follicular neoplasm.
Overturned
Experimental
Summary Reviewer 3 A 38-year-old male enrollee has requested reimbursement for genetic testing performed on 5/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. This patients initial biopsy was suspicious for follicular neoplasm. Genetic testing could obviate the need for a surgical procedure. Genetic testing on thyroid nodules is generally considered standard protocol on all fine needle aspirations done on thyroid nodules. The literature indicates that this testing can be performed to avoid unnecessary surgeries. The results from this testing may influence patient management. Thus, genetic testing performed on 5/31/18 was likely to have been more beneficial than other methods of evaluating this patient.
1
A 34-year-old female enrollee has requested reimbursement for genetic testing for birth defects performed on 3/28/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 2 A 34-year-old female enrollee has requested reimbursement for genetic testing for birth defects performed on 3/28/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the American College of Obstetricians and Gynecologists recommends cell free fetal DNA to be utilized as a primary screening test in women at increased risk of aneuploidy. This includes women aged 35 years or older, women with a positive first-trimester or second-trimester screening test result, fetuses with ultrasonographic findings that indicate an increased risk of aneuploidy, women with a history of a child affected with a trisomy, or a parent carrying a balanced Robertsonian translocation with increased risk of trisomy 13 or trisomy 21. In this case, the patient does not meet any of these criteria, thus the testing was not indicated. Therefore, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
0
A 25-year-old female enrollee has requested authorization and coverage for surgery to remove the uterus (laparoscopic or laparoscopic assisted vaginal hysterectomy). 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 has undergone a thorough evaluation, with no distinct etiology found. In this case, the patient has failed medical management options, including oral contraceptive pills and a short trial of Mirena intrauterine device, which she was unable to tolerate. She is not a candidate for tranexamic acid, given her prolonged bleeding pattern (greater than five days per month) and is of failure. The patient desires definitive management hysterectomy. Given that she has completed childbearing status-post bilateral salp
Overturned
Medical Necessity
Summary Reviewer A 25-year-old female enrollee has requested authorization and coverage for surgery to remove the uterus (laparoscopic or laparoscopic assisted vaginal hysterectomy). 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 abnormal uterine bleeding is a common gynecologic problem. Prolonged uterine bleeding can result in anemia and interfere with daily activities, as in this case. Abnormal uterine bleeding encompasses a heterogeneous group of conditions with diverse etiologies. Diagnosing the etiology of the abnormal uterine bleeding involves a thorough history, physical examination, imaging, and endometrial sampling. This patient has undergone a thorough evaluation, with no distinct etiology found. Initial management usually consists of progestin-based treatments, including combination oral contraceptive pills, the 52 mg levonorgestrel-releasing intrauterine device, and tranexamic acid. Surgical treatment options include endometrial ablation for patients who desire uterine sparing or definitive treatment with hysterectomy for patient who have completed childbearing. In this case, the patient has failed medical management options, including oral contraceptive pills and a short trial of Mirena intrauterine device, which she was unable to tolerate. She is not a candidate for tranexamic acid, given her prolonged bleeding pattern (greater than five days per month) and is not a candidate for endometrial ablation given her age and high risk of failure. The patient desires definitive management hysterectomy. Given that she has completed childbearing status-post bilateral salpingectomy, a hysterectomy is appropriate for this patient. Therefore, surgery to remove the uterus (laparoscopic or laparoscopic assisted vaginal hysterectomy) is medically necessary for the treatment of this patient.
1
patient is a 66-year-old male with a history of chronic neck pain associated with severe central spinal stenosis at C5-6 and moderately severe spinal stenosis at C6-7, cord compression, and myelopathy. The the MRI findings with severe pain, disability, and spinal cord compression at C5-6.
Overturned
Medical Necessity
Summary Reviewer The patient is a 66-year-old male with a history of chronic neck pain associated with severe central spinal stenosis at C5-6 and moderately severe spinal stenosis at C6-7, cord compression, and myelopathy. The clinical examination corroborates the MRI findings with severe pain, disability, and spinal cord compression at C5-6. The physician reviewer found that based upon the clinical findings corroborating the imaging findings and severe two-level degenerative disc disease with myelopathy, there is a need for urgent decompression. Per the current medical literature, a two-level total disc replacement at C5-6 and C6-7 is indicated. In the study referenced here, 599 patients were followed for seven years. At seven years, the two-level total disc replacement was found to be superior to anterior cervical discectomy and fusion. There were lower rates of revision surgery and lower rates of adjacent level disc disease. The surgery was very effective in relieving pain. Complication rate was very low. Overall, greater than 95% of patients were AaAvery satisfiedAaA at seven years. There is sufficient support for the requested services in this clinical setting. Therefore, the requested cervical disc arthroplasty is medically necessary for the treatment of this patient.
1
A 27-year-old female enrollee has requested reimbursement for CPT code 63659 (percutaneous implantation of neurostimulator electrode array, epidural) provided on 11/25/19. The Health Insurer has denied this request and reported that the device at issue was not medically necessary for the treatment of the enrollees medical condition. opioid consumption. In this case, the patient had chronic abdominal pain believed to be due to Sphincter of Oddi dysfunction. She had exhausted many of the standard therapeutic options, including nerve blocks, ERCP, stenting, as well as cognitive behavioral therapy and acupuncture, all with little benefit. She underwent a spinal cord stimulator trial and prior psychological screening and received significant improvement in her pain and a reduction in her opioid consumption.
Overturned
Medical Necessity
Summary Reviewer A 27-year-old female enrollee has requested reimbursement for CPT code 63659 (percutaneous implantation of neurostimulator electrode array, epidural) provided on 11/25/19. The Health Insurer has denied this request and reported that the device at issue was not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. A case report by Lee and colleagues demonstrated efficacy for the use of spinal cord stimulation for Sphincter of Oddi dysfunction. The researchers noted a reduction in visual analog pain scores as well as a reduction in opioid consumption. In this case, the patient had chronic abdominal pain believed to be due to Sphincter of Oddi dysfunction. She had exhausted many of the standard therapeutic options, including nerve blocks, ERCP, stenting, as well as cognitive behavioral therapy and acupuncture, all with little benefit. She underwent a spinal cord stimulator trial and prior psychological screening and received significant improvement in her pain and a reduction in her opioid consumption. The medical literature has shown efficacy of spinal cord stimulation for this indication. This patient validated the efficacy of this treatment for her condition by performing a stimulator trial. Therefore, CPT code 63650 (percutaneous implantation of neurostimulator electrode array, epidural) provided on 11/25/19 was medically necessary for the treatment of this patient.
1
patient is a 26-year-old female with a history of major depressive disorder. The patient has requested authorization and coverage for six additional sessions of adult mental health transcranial magnetic stimulation. . This patient qualifies for the diagnosis of treatment refractory depression given that she has failed more than three antidepressant trials in addition to psychotherapy. Additionally, she was evaluated by a psychiatrist who recommended TMS. The patient made significant gains with the beginning of TMS treatment, and
Overturned
Medical Necessity
Summary Reviewer The patient is a 26-year-old female with a history of major depressive disorder. The patient has requested authorization and coverage for six additional sessions of adult mental health transcranial magnetic stimulation. The physician reviewer found that per the literature, TMS is indicated for severe, recurrent major depressive disorder that has not responded to traditional medication and psychotherapy treatment. This patient qualifies for the diagnosis of treatment refractory depression given that she has failed more than three antidepressant trials in addition to psychotherapy. Additionally, she was evaluated by a psychiatrist who recommended TMS. The patient made significant gains with the beginning of TMS treatment, and it would be ill advised to discontinue this treatment before she has completed a full treatment cycle, as defined by the TMS psychiatrist. The medical evidence supports the use of TMS at this point in the decision- making algorithm for treatment-refractory depression. TMS is the appropriate next step in the treatment of this patient and should be completed until the patient has achieved maximal effect from this treatment. Therefore, six additional sessions of adult mental health transcranial magnetic stimulation are medically necessary for the treatment of this patient.
1
The parent of an 11-year-old male enrollee has requested authorization and coverage for child mental health outpatient services with Robert Colegrove, EdD. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who has a history of inattentive behavior, anxiety, avoidance behaviors, and difficulty with impulse control.
Upheld
Medical Necessity
Summary Reviewer The parent of an 11-year-old male enrollee has requested authorization and coverage for child mental health outpatient services with Robert Colegrove, EdD. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who has a history of inattentive behavior, anxiety, avoidance behaviors, and difficulty with impulse control. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested services. Per the records, psychological testing was requested to aid with determining the patients diagnosis and clarifying a written diagnosis of attention deficit/hyperactivity disorder. Psychological and neuropsychological tests are not mandatory for the diagnosis of attention deficit/hyperactivity disorder. The current standard of care for the diagnosis of attention deficit/hyperactivity disorder is through full clinical evaluation. In this case, the documentation suggests a diagnosis of attention deficit/hyperactivity disorder. Based on the current evidence, attention deficit/hyperactivity disorder is a clinical diagnosis, and testing is not needed to establish this diagnosis. Thus, the requested child mental health outpatient services with Robert Colegrove, EdD are not medically necessary for the treatment of this patient. Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
1
A 46-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 1/21/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer. In this case, the patients routine imaging studies as well as the sonogram was negative. Her breasts were described as having scattered fibroglandular elements, and were not dense. In addition, her studies were
Upheld
Experimental
Summary Reviewer 3 A 46-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 1/21/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found the breast tomosynthesis performed on 1/21/15 was not likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. The study by Howard and colleagues states Initial imaging for women with breast pain increased the odds of subsequent clinical utilization and did not increase reassurance in ruling out malignancy. In this case, the patients routine imaging studies as well as the sonogram was negative. Her breasts were described as having scattered fibroglandular elements, and were not dense. In addition, her studies were unchanged when compared to prior mammograms. In addition, breast pain is rarely associated with breast cancer, especially without a recognizable mass. If there had been a recognizable mass seen on the mammogram or sonogram, there may have been an indication for tomosynthesis. For the reasons provided, in this clinical setting the breast tomosynthesis was not likely to be more beneficial for evaluation of the patients medical condition than available standard modalities.Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 61-year-old male enrollee has requested reimbursement for genetic testing (81201, 81210, 81211, 81235, 81292, 81295, 81298 and 81321) performed on 2/13/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees metastatic colon cancer to the lung.
Overturned
Medical Necessity
Summary Reviewer A 61-year-old male enrollee has requested reimbursement for genetic testing (81201, 81210, 81211, 81235, 81292, 81295, 81298 and 81321) performed on 2/13/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees metastatic colon cancer to the lung. The physician reviewer found that the submitted documentation supports the medical necessity of a portion of the services at issue. It has not been established if molecular markers are useful in treatment determination (predictive markers) and prognosis other than for KRAS, NRAS, and BRAF mutation testing, microsatellite instability, and mismatch repair testing. Multiple clinical trials that are attempting to validate this personalized or precision medicine approach are in various stages of development and execution. Although preliminary data from some of these efforts have fueled excitement about the utility of these studies, their execution has also provoked many questions about the best way to approach complicating factors, such as tumor heterogeneity and the choice of which genetic mutations to target. Currently, it is unclear if molecular profiling is beneficial in identifying potential targets for treatment. Additionally, if targets are identified, it is unclear if targeted treatment is beneficial. In this patients case, the current evidence supports a portion of the services at issue. Specifically, 81210 (BRAF), 81235 (EGFR gene analysis, common variants), 81292 (MLH1 gene full sequence), 81295 (MSH2 gene full sequence) and 81298 (MSH6 gene full sequence) were medically necessary for the evaluation of this patient. However, the medical necessity of the remaining tests performed has not been established. Therefore, a portion of the services at issue was medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be partially overturned.
1
The parent of a 15-year-old male enrollee has requested reimbursement for quantification of therapeutic drug, not elsewhere specified and immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not specified, performed on 12/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. In this patientas case, he was symptomatic the day prior to the infusion. There was evidence of poor bone health, suggesting possible active disease.
Overturned
Experimental
Summary Reviewer 2 The parent of a 15-year-old male enrollee has requested reimbursement for quantification of therapeutic drug, not elsewhere specified and immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified, performed on 12/10/19. 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 therapeutic infliximab drug levels and antibodies are now considered as standard of care for management of patients on Remicade. Sufficient drug levels and negative antibody levels are important to maintain long-term efficacy of the drug. Modification of drug dose based on symptoms and/or levels and antibodies may help sustain continued remission. In this patientas case, he was symptomatic the day prior to the infusion. There was evidence of poor bone health, suggesting possible active disease. The medical evidence supports the services at issue in this clinical setting. All told, quantification of therapeutic drug, not elsewhere specified and immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified, performed on 12/10/19 was likely to have been more beneficial than other methods of evaluating this patient.
1
The patient is a 46-year-old female with a history of anxiety and depression and eating disorder. The patient has been prescribed bupropion (Wellbutrin) since at least 1997. She has been doing well with brand name Wellbutrin. A trial of generic bupropion reportedly lacked efficacy and tolerability, and required treatment with diphenhydramine for a possible allergic reaction. The patient has been treated with other psychotropic medications including venlafaxine, fluoxetine, trazodone, aripiprazole and buspirone without substantial improvement. The provider has ordered continuing therapy with brand name Wellbutrin XL. The patient has requested reimbursement and prospective authorization and coverage for brand name Wellbutrin XL from 3/9/17 forward. The Health Insurer has denied this request indicating that the medication at issue was not and is not medically necessary. Bupropi The patient previously failed treatment with various medications as well
Overturned
Medical Necessity
Summary Reviewer The patient is a 46-year-old female with a history of anxiety and depression and eating disorder. The patient has been prescribed bupropion (Wellbutrin) since at least 1997. She has been doing well with brand name Wellbutrin. A trial of generic bupropion reportedly lacked efficacy and tolerability, and required treatment with diphenhydramine for a possible allergic reaction. The patient has been treated with other psychotropic medications including venlafaxine, fluoxetine, trazodone, aripiprazole and buspirone without substantial improvement. The provider has ordered continuing therapy with brand name Wellbutrin XL. The patient has requested reimbursement and prospective authorization and coverage for brand name Wellbutrin XL from 3/9/17 forward. The Health Insurer has denied this request indicating that the medication at issue was not and is not medically necessary. Bupropion is a dual-acting medication that enhances both noradrenergic and dopaminergic tone in the central nervous system that was approved by the U.S. Food and Drug Administration (FDA) for treatment of depression in 1989. An extended release (XL) formulation was approved in 2003. In the medical literature, Sadock and colleagues noted that the possibility exists that differences in potency may underlie adverse changes in clinical status, when a brand name medicine is substituted with a generic, or even if there is a switch between specific generic manufacturers. This patient has been clinically stable on an evidence based antidepressant medication endorsed by current practice guidelines and community standards. The patient previously failed treatment with various medications as well as a trial of generic bupropion. All told, the brand name Wellbutrin XL provided from 3/9/17 forward, was and is medically necessary as it is reasonably expected to maintain the patients clinical stability and prevent an exacerbation of illness. Based on the available documentation, the medication at issue was and is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
A 52-year-old female enrollee has requested reimbursement for BCR-ABL gene rearrangement quantitative polymerase chain reaction (PCR) testing, BCR-ABL fluorescent in situ hybridization (FISH) performed on 11/21/22.
Upheld
Experimental
Summary Reviewer 2 A 52-year-old female enrollee has requested reimbursement for BCR-ABL gene rearrangement quantitative polymerase chain reaction (PCR) testing, BCR-ABL fluorescent in situ hybridization (FISH) performed on 11/21/22. The physician reviewer found that evaluation of a blood count with review of peripheral smear may warrant further testing with BCR-ABL. However, this patients records do not include clinical documentation to support an indication for BCR-ABL PCR or FISH testing. Elevated peripheral blood cell counts, such as leukocytosis, thrombocytosis, and polycythemia, are often the presenting symptom in a patient with a myeloproliferative neoplasm (MPN). Since cythemias are nonspecific and may reflect either a reactive or neoplastic process, diagnostic work-up requires integration of numerous diagnostic modalities. Wong and Pozdnyakova noted that, Although certain mutations are preferentially enriched in specific MPN types, none of these mutations are disease defining; therefore, a thorough work-up should always include a bone marrow biopsy for morphologic evaluation and diagnosis. Moreover, patients with rheumatoid arthritis can present with elevated white blood counts for a variety of reasons and does not merit the BCR-ABL PCR and FISH testing performed in this patients evaluation in lieu of standard testing. Therefore, the BCR-ABL gene rearrangement quantitative PCR testing, BCR-ABL FISH performed on 11/21/22 was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
1
A 39-year-old male enrollee has requested reimbursement for the inpatient hospital stay services provided from 9/21/15 through 9/27/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees degenerative disc disease (DDD) with herniations.
Upheld
Medical Necessity
Summary Reviewer A 39-year-old male enrollee has requested reimbursement for the inpatient hospital stay services provided from 9/21/15 through 9/27/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees degenerative disc disease (DDD) with herniations. The physician reviewer found the current medical literature with regard to two level total disc replacement in the lumbar spine includes varying outcomes. In a recent article published by Trincat and colleagues, the authors noted that two level lumbar disc replacement can improve spinal function while preserving its mobility but the procedure is fraught with risks and complications. Thus, longer follow-up is needed to evaluate the sustainability of the results and to detect any adjacent segment disease. A high-quality meta-analysis and health technology assessment concluded that there is insufficient evidence to draw extensive efficacy conclusions comparing artificial disc replacement with a broad range of recommended treatment options in the lumbar spine (Park, et al). All told, the efficacy remains uncertain and inadequate evidence exists to establish long-term benefits or harms. For these reasons, the inpatient hospital stay services provided from 9/21/15 through 9/27/15 were not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
0
patient is a 58-year-old female who fell from a horse while in Mexico on 7/27/22. The patient sustained bilateral rib fractures and bilateral pneumothoraces. The patient was transferred by air ambulance from Mexico to a facility in San Francisco, California. The Health Insurer has denied the air ambulance services as not medically necessary for treatment of the patients medical condition. In this case, the patient had been admitted in the initial hospital in Mexico for seven days. The records do not document that the patient had a flail chest or required emergent rib fixation. The initial hospital had already managed the left pigtail catheter for seven days, and the patients pain was controlled.
Upheld
Medical Necessity
Summary The patient is a 58-year-old female who fell from a horse while in Mexico on 7/27/22. The patient sustained bilateral rib fractures and bilateral pneumothoraces. The patient was transferred by air ambulance from Mexico to a facility in San Francisco, California. The Health Insurer has denied the air ambulance services as not medically necessary for treatment of the patients medical condition. This denial is the subject of this appeal and determination. The physician reviewer found that the air medical transport is considered medically necessary when the patients condition is life- threatening such that any form of transportation other than ambulance would be medically contraindicated, the time needed to transport by ground poses a threat to the patients survival, and the patient is transported to the nearest hospital with appropriate facilities for treatment. When transporting from one hospital to another, the air medical transport criteria must be met, and the initial hospital must not have the required services and facilities available to treat the patient. In this case, the patient had been admitted in the initial hospital in Mexico for seven days. The records do not document that the patient had a flail chest or required emergent rib fixation. The initial hospital had already managed the left pigtail catheter for seven days, and the patients pain was controlled. For these reasons, the air ambulance services were not medically necessary for treatment of this patient.
1
A 60-year-old male enrollee has requested reimbursement for Oncotype testing performed on 4/25/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
Overturned
Experimental
Summary Reviewer 1 A 60-year-old male enrollee has requested reimbursement for Oncotype testing performed on 4/25/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there currently are three major approaches to the management of localized prostate cancer. These are surgical prostatectomy, forms of radiation therapies, and active surveillance, with no specific anti-cancer treatment given. The treatment recommendation is based on risk stratification, which is a methodology combining pathologic and clinical features. In this case, the patient would be classified as being in the favorable intermediate risk category, for which it is not entirely clear what recommendation should be made. The National Comprehensive Cancer Network suggests using genomic assays as an adjunct to treatment decisions in this risk category. Oncotype DX assay is a 17-gene assay that is capable of assessing risk of recurrent disease. In this patients case, adding Oncotype assay to his evaluation was likely to have been beneficial. Therefore, Oncotype DX testing performed on 4/25/19 was likely to have been of greater benefit than other methods of evaluating this patient.
0
A 62-year-old male enrollee has requested reimbursement for the IgG food sensitivity testing provided on 2/10/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees abdominal discomfort.
Upheld
Experimental
Summary Reviewer 2 A 62-year-old male enrollee has requested reimbursement for the IgG food sensitivity testing provided on 2/10/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees abdominal discomfort. The physician reviewer found based on the current literature and guidelines that address IgG diagnostic testing, IgG food sensitivity testing is not considered a clinically useful, relevant, or valid method for evaluation of abdominal discomfort, or for identifying food allergy or food intolerance that may be contributing to abdominal discomfort or other gastrointestinal symptoms. IgG and IgG subclass antibody tests for food allergy related conditions do not have clinical relevance and lack sufficient quality control, and should not be performed (Boyce, et al). All told, the IgG food sensitivity testing performed on 2/10/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
0
The patient is a 20-year-old male with significant daytime frequency every hour and nocturia every four to six hours. The patient reportedly also has insomnia. The patient has tried pelvic floor muscle rehabilitation as well as multiple medications including oxybutynin, Vesicare, and Myrbetriq. The patient experienced side effects and no substantial improvement in his symptoms with these therapies. The patient is currently on desmopressin with some improvement. The patient has requested reimbursement for percutaneous tibial nerve stimulation (PTNS) provided on 10/16/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational. It was suggested that this patient undergo treatment with PTNS therapy for significant urinary frequency. The records document treatment failure with multimodal primary and secondary treatments for his condition. He does not wish to proceed with sacral neuromodulation or Botox injections.
Upheld
Experimental
Summary Reviewer 3 The patient is a 20-year-old male with significant daytime frequency every hour and nocturia every four to six hours. The patient reportedly also has insomnia. The patient has tried pelvic floor muscle rehabilitation as well as multiple medications including oxybutynin, Vesicare, and Myrbetriq. The patient experienced side effects and no substantial improvement in his symptoms with these therapies. The patient is currently on desmopressin with some improvement. The patient has requested reimbursement for percutaneous tibial nerve stimulation (PTNS) provided on 10/16/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational. It was suggested that this patient undergo treatment with PTNS therapy for significant urinary frequency. The records document treatment failure with multimodal primary and secondary treatments for his condition. He does not wish to proceed with sacral neuromodulation or Botox injections. As noted in the medical literature, PTNS is performed as a salvage procedure. For these reasons, the PTNS provided on 10/16/17 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 68-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with endocardial implant (Watchman device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees atrial fibrillation.
Overturned
Experimental
Summary Reviewer 3 A 68-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with endocardial implant (Watchman device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees atrial fibrillation. The physician reviewer found that the Watchman device is an effective and relatively safe option for patients with atrial fibrillation who require but cannot take long-term anticoagulation. However, this patient underwent successful atrial fibrillation ablation with no documented recurrence of atrial fibrillation when the device had been regularly interrogated. Therefore, long-term anticoagulation would not be indicated to justify the need for a Watchman device. Thus, the superior efficacy of the requested percutaneous transcatheter closure of the left atrial appendage with endocardial implant (Watchman device) has not been demonstrated. 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
The parent of a 13-year-old male enrollee has requested authorization and coverage for Privigen. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition.
Overturned
Experimental
Summary Reviewer 3 The parent of a 13-year-old male enrollee has requested authorization and coverage for Privigen. 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 while PANDAS is not a diagnosis that has held up to careful scrutiny, autoimmune encephalitis with a vast range of neuropsychiatric symptomatology has. Additionally, the diagnosis of methylene tetrahydrofolate reductase (MTHFR) deficiency may manifest as isolated neuropsychiatric disease. Given that this patient has been closely followed for MTHFR and will continued to be monitored for homocysteinemia and treated appropriately with B9, B12 and betaine if this becomes problematic, his clinical response to Privigen (IVIG) has been sufficient to justify its continued use for his recurrent neuropsychiatric symptomatology that is presumably due to his autoimmune encephalitis. There is support for the requested medication in this clinical setting. Thus, Privigen is likely to be more beneficial than other available treatment options.
0
A 51-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma assay performed on 10/16/18. 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.
Upheld
Medical Necessity
Summary Reviewer A 51-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma assay performed on 10/16/18. 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 this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy. The current medical evidence does not support the services at issue in this clinical setting. Therefore, DecisionDx-Melanoma assay performed on 10/16/18 was not medically necessary for the evaluation of this patient.
0
The patient is a 67-year-old male who was diagnosed with melanoma. The patient has requested reimbursement for DecisionDx-Melanoma testing performed on 1/01/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.
Upheld
Medical Necessity
Summary Reviewer The patient is a 67-year-old male who was diagnosed with melanoma. The patient has requested reimbursement for DecisionDx-Melanoma testing performed on 1/01/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that this patient has an early stage melanoma. Gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Newer prognostic molecular techniques should not replace standard staging procedures. There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. Therefore, DecisionDx-Melanoma testing performed on 1/01/20 was not medically necessary for the evaluation of this patient.
1
A 57-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 12/17/15 and 1/12/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk for breast cancer.
Overturned
Experimental
Summary Reviewer 1 A 57-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 12/17/15 and 1/12/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that in the peer-reviewed medical literature, Skaane and colleagues found that the addition of three dimensional digital breast tomosynthesis to two dimensional full field digital mammography resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Thus, although additional studies are needed to confirm these findings, there is adequate data to support the utility of three dimensional digital breast tomosynthesis in this clinical setting. For these reasons, the breast tomosynthesis studies performed on 12/17/15 and 1/12/16 were likely to be more beneficial for evaluation of this 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 65-year-old male enrollee has requested authorization and coverage for PET (CPT code 78813) scan. The Health Insurer has denied this request indicating that the requested testing considered investigational for evaluation of the enrollees prostate cancer.
Overturned
Experimental
Summary Reviewer 1 A 65-year-old male enrollee has requested authorization and coverage for PET (CPT code 78813) scan. The Health Insurer has denied this request indicating that the requested testing considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found that overall, the use of fluciclovine PET is likely to be more beneficial in the management of the above patient when compared to standard techniques of evaluating this patients medical condition. 18F-fluciclovine was U.S. Food and Drug Administration approved in 2016 for the patients specific clinical scenario of suspected recurrent prostate cancer in patients with elevated PSA after prior therapy (Zanoni et al). The most recent National Comprehensive Cancer Network (NCCN) guidelines support its use in this setting (recurrent or persistent disease after initial treatment), specifically stating that F-18 fluciclovine PET/CT may be used to detect small volume disease in soft tissue. Performance is generally poor when PSA < 2.0ng/mL. Of note, the PSA for the above patient is 2.5 ng/mL. The studies have shown that fluciclovine PET is more sensitive to detecting residual prostate cancer than bone scan or conventional computed tomography (CT) (Schuster, et al). Akin-Akintayo and colleagues specifically evaluated the use of fluciclovine PET/CT and its influence on postoperative radiotherapy treatment fields in patients with recurrent prostate cancer. They found that the results of a fluciclovine PET changed the radiation fields in 40.5% of the evaluated patients. Additionally, 4.8% of patients had radiotherapy withheld after the discovery of extra pelvic disease. There is a significant chance that fluciclovine PET will influence the patients salvage radiotherapy. All told, PET (CPT code 78813) scan is likely to be more effective for the evaluation of this patient as compared to conventional techniques. Therefore, for the reasons stated 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.
1
The patient is a 20-year-old male who was admitted to a residential treatment center (RTC) on 8/18/22 and presented for a psychiatric evaluation on 8/19/22. The records noted that the patient had previously been treated at the facilitys partial hospitalization program (PHP) but that the patient had been unable to maintain sobriety while in the program and after discharge. has a moderate risk of harm, due to extreme distress and a history of suicidal behaviors including a previous overdose, and self-harm by hitting himself, without active s in physical functioning, including disrupted sleep with nearly nightly nightmares and fatigue,
Overturned
Medical Necessity
Summary Reviewer The patient is a 20-year-old male who was admitted to a residential treatment center (RTC) on 8/18/22 and presented for a psychiatric evaluation on 8/19/22. The records noted that the patient had previously been treated at the facilitys partial hospitalization program (PHP) but that the patient had been unable to maintain sobriety while in the program and after discharge. The physician reviewer found that the issue is whether residential behavioral health from 9/7/22 through discharge was and is medically necessary for the treatment of this patient. The American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) provides a reliable framework for determining the appropriate level of care for adults needing mental health treatment. Using LOCUS, 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) medical, addictive and psychiatric comorbidity; (4) recovery environment (a. stressors and b. supports); (5) treatment and recovery history; and (6) engagement. The composite score is then used to determine the level of care needed. With regard to risk of harm, the records support a score of 3. The patient has a moderate risk of harm, due to extreme distress and a history of suicidal behaviors including a previous overdose, and self-harm by hitting himself, without active suicidal or homicidal ideation. In terms of functional status, the records support a score of 4. The documentation noted serious functional impairment due to serious disturbances in physical functioning, including disrupted sleep with nearly nightly nightmares and fatigue, that threaten his physical wellbeing. With regard to comorbidity, the records support a score of 4. The patient has major comorbidity due to the presence of multiple serious psychiatric symptoms, including insomnia, severe anxiety, obsessive thoughts, and depressive symptoms, which are clearly disabling and which interact with and seriously impair the patients ability to recover from his co-occurring alcohol and cannabis use disorders. In terms of level of stress of the recovery environment, the records support a score of 3. The patient has a moderately stressful environment due to ongoing significant discord and difficulties in his family, specifically major conflict in the relationship with his mother. With regard to level of support of the recovery environment, the records support a score of 3 as the patient has a few supportive resources in the current environment that may be capable of providing some help if needed including his brother and father. In terms of resiliency and treatment history, the records support a score of 4. The patient has poor response to treatment and recovery management, as prior and current treatment have not achieved complete remission of symptoms or optimal control of symptoms even with intensive and repeated exposure. The patient remains severely anxious, with ongoing cravings for alcohol and cannabis. The patient has undergone a previous course of PHP at the same facility, without adequate control of his symptoms. With regard to treatment acceptance and engagement, the records support a score of 3. The patient has some variability, hesitation, or uncertainty in acceptance or understanding of his illness and disability. He has limited desire or lacks confidence to change despite intentions to do so, particularly with respect to his substance use disorder. Thus, the patient has a total score of 24. The records support a 4 in terms of functional status and comorbidity. In this case, the recommended level of care is medically monitored residence-based services. With the functional impairment and comorbidity noted, the patient meets LOCUS 5b extended stay criteria. Therefore, residential behavioral health from 9/7/22 through discharge was and is medically necessary for the treatment of this patient.
1
patient is a 16-year-old male with diagnoses of other specified anxiety disorder, cannabis use disorder, severe, and parent-child relational problem. He started using marijuana in eighth grade, and was using daily by the end of eighth grade. patient had a significant risk of harm, due to binge or excessive use of alcohol or other drugs, resulting moderate functional impairment, due to conflict with parents, recent sobriety and
Upheld
Medical Necessity
Summary Reviewer The patient is a 16-year-old male with diagnoses of other specified anxiety disorder, cannabis use disorder, severe, and parent-child relational problem. He started using marijuana in eighth grade, and was using daily by the end of eighth grade. The physician reviewer found that the Child and Adolescent Level of Care Utilization System (CALOCUS) provides a framework for determining the clinically appropriate level of care for a child or adolescent in mental health treatment. With regard to risk of harm, the records support a score of 3. The patient had a significant risk of harm, due to binge or excessive use of alcohol or other drugs, resulting in potentially harmful behaviors. In terms of functional status, the records support a score of 3. The documentation indicated moderate functional impairment, due to conflict with parents, recent sobriety and stabilization of mood achieved in a structured and protected setting (wilderness treatment program). With regard to comorbidity, the records support a score of 3. The documentation indicated significant comorbidity due to significant anxiety symptoms contributing to substance use. In terms of level of stress of the recovery environment, the records support a score of 1. The patient had a minimally stressful environment, due to the absence of difficulties in his life circumstances. With regard to environmental support, the records support a score of 2 due to his parents active participation in treatment and ability to meet patients material needs. In terms of resiliency and treatment history, the records support a score of 3 due to maintenance of abstinence and mood stability in the structured environment of the wilderness program, with no prior attempts at outpatient treatment. With regard to the patients acceptance and engagement, the records support a score of 2 due to his active participation in treatment at the wilderness program. Thus, the patient has a composite score of 17. This is consistent with an intensive outpatient or partial hospital program. There is no evidence that this level of care had been tried for this patient. Therefore, mental health residential treatment provided from 5/06/19 through 12/31/19 was not medically necessary for the treatment of this patient.
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.
Upheld
Experimental
Summary Reviewer 2 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 this patient has an early stage melanoma. Commercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and SLNB status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Newer prognostic molecular techniques should not replace standard staging procedures. There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. All told, DecisionDx-Melanoma testing performed on 4/15/19 was not likely to have been more beneficial than other methods of evaluating this patient.
1
A 45-year-old female enrollee has requested reimbursement for the Decision Dx melanoma test performed on 4/4/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma. The physician reviewer found the patient was diagnosed with a nevoid melanoma measuring 0.42 mm Breslow depth on the right cheek. She underwent Decision Dx Melanoma gene testing to assess the risk of metastatic disease.
Upheld
Experimental
Summary Reviewer 3 A 45-year-old female enrollee has requested reimbursement for the Decision Dx melanoma test performed on 4/4/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma. The physician reviewer found the patient was diagnosed with a nevoid melanoma measuring 0.42 mm Breslow depth on the right cheek. She underwent Decision Dx Melanoma gene testing to assess the risk of metastatic disease. The use of Decision Dx Melanoma gene testing is not recommended outside of clinical trials according to the National Comprehensive Cancer Network guidelines. In addition, the testing at issue is not the standard of care in melanoma treatment or work-up. For the reasons provided, the Decision Dx melanoma test performed on 4/4/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 45-year-old female enrollee has requested authorization and coverage for L-methylfolate. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee, who is homozygous for methylene tetrahydrofolate reductase (MTHFR) enzyme deficiency. The patient has trialed many standard therapies for major depressive disorder, . The patient has a genetic test that demonstrates a defective MTHFR gene which suggests L-methylfolate deficiency. Finally, the patient is reportedly in remission on the combination of bupropion and L-methylfolate.
Overturned
Medical Necessity
Summary Reviewer A 45-year-old female enrollee has requested authorization and coverage for L-methylfolate. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee, who is homozygous for methylene tetrahydrofolate reductase (MTHFR) enzyme deficiency. The physician reviewer found there is sufficient support for the requested medication in this clinical setting. Folic acid is vitamin B9. It is converted to L-methylfolate, the active form of the vitamin in the body, by an enzyme, MTHFR. If individuals lack the ability to convert folic acid, they may be prescribed synthetic L-methylfolate. It is hypothesized that L-methylfolate may help the body create neurotransmitters such as serotonin, dopamine and norepinephrine, and thus may augment antidepressant medications for those struggling with treatment-resistant depression. Despite the rather limited data, L-methylfolate is safe and reasonably expected to improve the patients condition in this case. The patient has trialed many standard therapies for major depressive disorder, to no avail. Thus, the affective illness can be characterized as treatment-resistant depression. The patient has a genetic test that demonstrates a defective MTHFR gene which suggests L-methylfolate deficiency. There are several well-designed studies that demonstrate the benefit of L-methylfolate augmentation. Further, when considering the favorable safety profile, the potential benefits appear to outweigh the risks of treatment. Finally, the patient is reportedly in remission on the combination of bupropion and L-methylfolate. Thus, L-methylfolate is medically indicated for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
A 28-year-old female enrollee has requested reimbursement for the treatment of dry eye performed on 6/02/15 (codes 68761, 83861 and 92285). The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees dry eyes. Her provider previously recommended use of artificial tears, omega-3 fatty acid supplements, lid hygiene twice daily and sleeping with a humidifier.
Overturned
Medical Necessity
Summary Reviewer A 28-year-old female enrollee has requested reimbursement for the treatment of dry eye performed on 6/02/15 (codes 68761, 83861 and 92285). The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees dry eyes. The physician reviewer found there is sufficient support for the services at issue in this patients case. The patients dry eye syndrome has not responded to the usual medical therapies, including Restasis drops. Her provider previously recommended use of artificial tears, omega-3 fatty acid supplements, lid hygiene twice daily and sleeping with a humidifier. The use of punctum plugs is the next logical therapeutic regimen. All told, treatment of dry eye performed on 6/02/15 was medically indicated 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
patient is a 21-year-old female who sustained a traumatic nasal injury playing soccer on 10/02/17 when she was hit in the nose by a studentas hand. The school nurse reported a nosebleed with the nose slightly swollen. a Physical examination 7/17/20 reported, aThe nasal dorsum continues to be crooked with the tip of the nose pointing to the left sideaWe appears that the dorsum pointing to the left is pulling the anterior portion of the nasal septum to the left as well, creating a rightward deviation of the nasal septum interfering with the nasal airway.a A photograph dated 10/11/17, nine days after injury, shows right-sided deviation of the nose and nasal bones. An undated photograph shows a reverse C-deformity of the nose with a deviation of the nasal bones to the left, and a compensatory deviation of the nasal tip to the right. The patient underwent authorized septoplasty for relief of breathing obstruction. Photographs were received for review documenting that the nasal deviation was functionally significant.
Overturned
Medical Necessity
Summary Reviewer The patient is a 21-year-old female who sustained a traumatic nasal injury playing soccer on 10/02/17 when she was hit in the nose by a studentas hand. The school nurse reported a nosebleed with the nose slightly swollen. The physician reviewer found that Friedman and colleagues stated, aUnderstanding nasal anatomy and physiology are the most important points for successful functional rhinoplasty. Anatomic structures playing major roles in nasal breathing functions include the septum, and internal and external nasal valves, so physical examination of these regions is essential. Planning for functional rhinoplasty involves the identification of the sites of nasal airway obstruction or old trauma and addressing those regions during the operation with a number of different techniques that have been described.a Physical examination 7/17/20 reported, aThe nasal dorsum continues to be crooked with the tip of the nose pointing to the left sideaWe would recommend a septoplasty as well as consideration for an open reduction of her nasal fracture since the way the fracture has healed, it appears that the dorsum pointing to the left is pulling the anterior portion of the nasal septum to the left as well, creating a rightward deviation of the nasal septum interfering with the nasal airway.a A photograph dated 10/11/17, nine days after injury, shows right-sided deviation of the nose and nasal bones. An undated photograph shows a reverse C-deformity of the nose with a deviation of the nasal bones to the left, and a compensatory deviation of the nasal tip to the right. The patient underwent authorized septoplasty for relief of breathing obstruction. Photographs were received for review documenting that the nasal deviation was functionally significant. Narrowing of the nasal valve is evident on the left side. The medical history received for review documents the medical necessity of the rhinoplasty in addition to the authorized septoplasty. Based on the medical history received for review, rhinoplasty was medically necessary. Therefore, CPT 30400 performed on 9/16/20 was medically necessary for the treatment of this patient. The California reconstructive surgery statute requires health insurers to cover reconstructive surgeries, defined as surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) to improve function or (2) to create a normal appearance, to the extent possible. Per the submitted documentation, the patientas condition constituted an abnormal structure of the body. This abnormal structure of the body was caused by trauma. The surgery was performed to improve function. Therefore, the California reconstructive surgery statute does apply to the patient. Thus, CPT 30400 performed on 9/16/20 was reconstructive in nature.
1
A 68-year-old male requested authorization and coverage for UroLift procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees benign prostatic hyperplasia (BPH).
Overturned
Experimental
Summary Reviewer 1 A 68-year-old male requested authorization and coverage for UroLift procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees benign prostatic hyperplasia (BPH). The physician reviewer found that the requested procedure (UroLift system) is a minimally invasive approach to treating BPH that lifts or holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. Recent clinical trials, including prospective, sham controlled, randomized studies, have shown that this procedure is safe and effective in relieving lower urinary tract symptoms due to BPH without significantly compromising sexual function. Compared with transurethral resection of the prostate and photoselective laser vaporization of the prostate, UroLift is a minimally invasive procedure without a requirement of general anesthesia and with a potentially shorter operative time. As such UroLift procedure is likely to be more effective than other options for the treatment of this patient Therefore, for the reasons stated 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
patient is a 50-year-old male with a history of bipolar I disorder, current or most recent episode manic with psychotic features, and alcohol use disorder, severe, in early remission. The patient was admitted to the residential treatment center (RTC) on 12/13/22. The patient has requested reimbursement for adult mental health RTC services provided from 12/20/22 through 1/3/23. The Health Insurer has denied the services at issue as not medically necessary for the treatment of the patients medical condition.
Upheld
Medical Necessity
Summary The patient is a 50-year-old male with a history of bipolar I disorder, current or most recent episode manic with psychotic features, and alcohol use disorder, severe, in early remission. The patient was admitted to the residential treatment center (RTC) on 12/13/22. The patient has requested reimbursement for adult mental health RTC services provided from 12/20/22 through 1/3/23. The Health Insurer has denied the services at issue as not medically necessary for the treatment of the patients medical condition. This denial is the subject of this appeal and determination. The physician reviewer found that the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) provides a reliable framework for determining the appropriate level of care for adults needing mental health treatment. Using LOCUS, 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) medical, addictive and psychiatric comorbidity; (4) recovery environment (a. stressors and b. supports); (5) treatment and recovery history; and (6) engagement. The composite score is then used to determine the level of care needed. Applying the LOCUS framework, this patient did not meet the criteria for RTC services provided from 12/20/22 through 1/3/23. For dimension 1, the patient was at low risk of harm (score 2) due to no active suicidal ideation but extreme distress and/or a history of suicidal behavior exists. Per the history, the patient experienced an exacerbation of mood and psychotic symptoms after abruptly discontinuing Lamictal, gabapentin, and Antabuse. However, the patients objective mental status examination was not consistent with the history of the present illness. The patient denied suicidal and homicidal ideation, and there was no obvious overt sign of psychosis during the interview. For dimension 2, the patient demonstrated mild functional impairment (score 2) given his recent experience of some minor disruptions in aspects of self-care or usual activities. There was a lack of evidence that the patient was gravely disabled without supervision 24 hours per day to develop skills necessary for daily living. The group notes describe the patient as well-groomed, performing activities of daily living, and sleeping well. For dimension 3, the patient has significant comorbidities (score 3). The records document recent substance use which has had clearly detrimental effects on the presenting disorder but which has been temporarily arrested through the use of a highly structured or protected setting or through other external means. The patient has a history of ADHD, bipolar disorder, and alcohol abuse. (e) For dimension 4A, the patients recovery environment was mildly stressful (score 2) considering the patients potential for exposure to alcohol and or drug use existed. The records indicate that the patient has a place to stay and was previously sober in that living environment. For dimension 4B, the patients recovery environment provided limited support (score 3). The records document that a few supportive resources existed in the current environment and may have been capable of providing some help if needed. The patient has a place to stay, has been sober before in that living environment, and had minimal social stressors to increase his relapse risk. For dimension 5, the patient has exhibited a significant response to treatment and recovery management (score 2). The provider noted that recovery has been managed for moderate periods of time with limited support or structure. Previous outpatient treatment has been successful for the patient, he has maintained periods of sobriety in the past, and this relapse could have been managed in an outpatient setting. For dimension 6, the patient has shown positive engagement and recovery (score 2) since he demonstrated significant understanding and acceptance of his illness and its effect on his function. The patient was engaged in treatment at the facility and shared insight into his alcohol use. The provider noted that the patient participated in all therapy sessions and was motivated to make changes to become abstinent. The patient has been sober in treatment at a lower level of care in the past. These findings give the patient a composite score of 16, which is consistent with Level 2 low-intensity community-based services. Therefore, the adult mental health RTC services provided from 12/20/22 through 1/3/23 were not medically necessary for the treatment of the patients condition.
1
A 60-year-old male enrollee has requested reimbursement for the subtalar arthrodesis provided on 11/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees hallux valgus.
Upheld
Experimental
Summary Reviewer 3 A 60-year-old male enrollee has requested reimbursement for the subtalar arthrodesis provided on 11/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees hallux valgus. The physician reviewer found that the enclosed information and available literature on subtalar arthroereisis for the treatment of adult flexible flat foot do not demonstrate that the subtalar arthrodesis provided on 11/23/15 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. According to the medical literature, subtalar arthroereisis demonstrates good efficacy in re-aligning the subtalar joint, and reducing overpronation. However, there is a lack of large population studies to examine the efficacy of this procedure in reducing foot pain. Further studies are also needed to evaluate the long-term efficacy of this implant as it sits in the subtalar joint for many years. Long range analysis of side effects must be studied as well. Currently orthotics, Ritchie braces, and Arizona braces are standard of care for pathologic subtalar joint overpronation and its associated pain. 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.
1
A 45-year-old male enrollee has requested reimbursement for gene analysis performed on 8/14/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
Overturned
Medical Necessity
Summary Reviewer A 45-year-old male enrollee has requested reimbursement for gene analysis performed on 8/14/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that per the National Comprehensive Cancer Network (NCCN) guidelines, Extraocular recurrence or metastasis of ocular/uveal melanoma should be confirmed histologically whenever possible or if clinically indicated. The NCCN guidelines recommend that providers, Obtain tissue for genetic analysis (screening for mutations that may be potential targets for treatment or determine eligibility for a clinical trial) from either biopsy of the metastasis (preferred) or archival material if the patient is being considered for targeted therapy. Per NCCN guidelines, providers should consider broader genomic profiling if the test results might guide future decisions or eligibility for participation in a clinical trial. For patients with metastatic uveal melanoma, enrollment in a clinical trial is often recommended. The literature is not directive regarding the specific systemic agent(s) offering superior outcomes, but does provide evidence that uveal melanoma is sensitive to some of the same systemic therapies used to treat cutaneous melanoma. The medical evidence supports the services at issue in this clinical setting. Therefore, gene analysis performed on 8/14/19 was medically necessary for the evaluation of this patient.
0
A 55-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 1/24/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
Overturned
Experimental
Summary Reviewer 1 A 55-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 1/24/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there currently are three major therapeutic approaches to the management of localized prostate cancer. These include prostatectomy, forms of radiation therapy, and active surveillance, with no specific anti-cancer treatment. Recommendations are made as to these options based on risk stratification, which involves calculating an estimate of the risk for the future development of recurrence. The patients cancer is evaluated using the pathology, prostate-specific antigen (PSA) level and clinical stage. By such a method, patients can essentially be placed into one of four major risk categories, ranging from very low, to low, to intermediate, to high risk. By such categorization, this patient would be placed in the low risk category. A further refinement of risk analysis can be performed with gene panels such as Oncotype DX Prostate testing. This is a 17-gene panel that may assist in predicting recurrence of the cancer after treatment. Increasingly, it is being used in prostate cancer. The National Comprehensive Cancer Network suggests considering such a panel for low to intermediate risk prostate cancer. Therefore, Oncotype DX Prostate testing performed on 1/24/19 was likely to have been more beneficial than any available standard therapy.
1
A 51-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 9/29/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
Upheld
Experimental
Summary Reviewer 2 A 51-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 9/29/20. 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 Guardant360 is a multigene and mutational assay done on the DNA found in the blood, presumably shed by metastatic cancer cells. This testing can be used instead of a tissue assay when it is not possible or safe to do a biopsy. There are certain situations where such mutational assay has been useful in selecting therapy, e.g., in non-small cell lung cancer. However, its overall use in predicting which agent might be useful has not been convincingly shown. A randomized study by Le Tourneau and colleagues did not demonstrate advantage to selecting treatment based on an assay versus the oncologistas judgment. As noted by Marquart and colleagues, the percentage of patients who benefit from such an approach appears to be low. In this particular case, a genomic assay had previously been done on the metastatic disease (Foundation One assay). It appears the oncologist ordered Guardant360 as a re-check on the Foundation One findings. There is a lack of real data indicating that the Guardant assay can reliably be used for that purpose. Overall, there is a lack of data to suggest that the Guardant assay is likely to be of clinical benefit in this setting. Therefore, Guardant360 testing performed on 9/29/20 was not likely to have been more beneficial than other available standard therapy.
0
A 33-year-old female enrollee has requested reimbursement for fecal lactoferrin testing performed on 12/06/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeAaas medical condition.
Upheld
Experimental
Summary Reviewer 3 A 33-year-old female enrollee has requested reimbursement for fecal lactoferrin testing performed on 12/06/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeAaas medical condition. The physician reviewer found that the documentation does not reveal that the provider seeks to differentiate between inflammatory bowel disease (CrohnAaas disease and ulcerative colitis) and irritable bowel syndrome. The medical records does not identify features to support one diagnosis over the other. A gastroenterologist uses the clinical history along with laboratory studies including surrogate studies to obtain clues to ongoing inflammation related to the suspecting an underlying disorder of inflammatory bowel disease. In addition, radiographic studies and endoscopic evaluation are tools that can be used but carry their own potential risks. The patient underwent fecal lactoferrin to assess the level of inflammation. An elevated fecal lactoferrin is not specific for inflammatory bowel disease. Any inflammatory process within the gastrointestinal tract will result in the activation of the innate immune response and release of calprotectin. Fecal calprotectin concentration has been shown in studies to be elevated in many conditions, including rheumatologic conditions. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to cause significant increases in fecal lactoferrin levels. Proton pump inhibitors (PPIs) have been associated with significantly elevated fecal lactoferrin levels, regardless of reason for PPI. There is a lack of support for the services at issue in this clinical setting. Therefore, fecal lactoferrin testing performed on 12/06/19 was
0
An 18-year-old female enrollee has requested reimbursement for residential mental health treatment for children and adolescents from 8/13/15 through 12/31/16. 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. attending to activities of daily living. During the admission at the residential facility, the patient was documented as having an anxious and low mood at times. However, she was more frequently documented as having an appropriate mood and attitude with cooperative behavior. Individual progress notes indicated that the patient had no suicide or self-harm risk. She was noted to be engaged and participated in group. Per the psychiatric progress note dated 10/19/15, the patient record noted depression and an episode of self-harm. Subsequent psychiatric progress notes documented the patient as having a good/appropriate mood, no suicidal ideation, and no reports of self-harm.
Upheld
Medical Necessity
Summary Reviewer An 18-year-old female enrollee has requested reimbursement for residential mental health treatment for children and adolescents from 8/13/15 through 12/31/16. 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 the submitted documentation does not support the services at issue in this clinical setting. Upon admission to the residential facility, the record did not contain notations as to frequent suicidal or homicidal ideation, aggression, self-injurious behavior, abnormal vital signs, documentation of withdrawal from substances, urges to use substances, non-response or adverse response to medications, frequent medication changes, or difficulty with attending to activities of daily living. During the admission at the residential facility, the patient was documented as having an anxious and low mood at times. However, she was more frequently documented as having an appropriate mood and attitude with cooperative behavior. Individual progress notes indicated that the patient had no suicide or self-harm risk. She was noted to be engaged and participated in group. Per the psychiatric progress note dated 10/19/15, the patient record noted depression and an episode of self-harm. Subsequent psychiatric progress notes documented the patient as having a good/appropriate mood, no suicidal ideation, and no reports of self-harm. There was a lack of documentation to indicate significant adverse effects to the medications and there were few documented medication changes. The American Academy of Child and Adolescent Psychiatrys (AACAP) Child and Adolescent Service Intensity Instrument (CASII) was developed to help determine the appropriate level of service intensity for behavioral health treatment for youth (AACAP, 2014). The CASII utilizes dimensions that are relevant to the youths clinical status when determining appropriate level of service intensity. These dimensions include risk of harm, functional status, co-occurrence, environmental stress, environmental support, resiliency and/or response to services, child/adolescent involvement in services, and parent involvement in services. According to the patients clinical history and documentation as outlined above, at the time of admission to the residential facility, the patient met CASII criteria for intensive outpatient services and not residential level of care treatment services. As such, residential mental health treatment from 8/13/15 through 12/31/16 was not medically necessary for treatment of this patients medical condition. (Marshall, et al; AACAP; Mee-Lee and Shulman).
1
A 46-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 1/21/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer.
Upheld
Experimental
Summary Reviewer 2 A 46-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 1/21/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found there is a lack of evidence in the peer-reviewed literature that supports the use of breast tomosynthesis compared to currently available techniques. Although digital breast tomosynthesis is a promising technology, there is a lack of peer-reviewed literature supporting its use in this clinical setting. Therefore, the breast tomosynthesis performed on 1/21/15 was not likely to be more beneficial than standard modalities. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 34-year-old female enrollee has requested authorization and coverage for ivabradine (Corlanor) 7.5 mg tablet. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees dysautonomia with postural orthostatic tachycardia syndrome (POTS). The physician that the patient has documented dysautonomia with POTS, with inappropriate and symptomatic sinus tachycardia on cardiac monitors which has been severely symptomatic and life-limiting over an extended period. In addition to Florinef and Northera to treat POTS, she has been tried on the standard first-line standard therapies including beta blockers, which were ineffective, and midodrine which caused side effects. She was recently started on Corlanor which has markedly improved her symptomatology and tachycardia.
Overturned
Medical Necessity
Summary Reviewer A 34-year-old female enrollee has requested authorization and coverage for ivabradine (Corlanor) 7.5 mg tablet. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees dysautonomia with postural orthostatic tachycardia syndrome (POTS). The physician reviewer found that the patient has documented dysautonomia with POTS, with inappropriate and symptomatic sinus tachycardia on cardiac monitors which has been severely symptomatic and life-limiting over an extended period. In addition to Florinef and Northera to treat POTS, she has been tried on the standard first-line standard therapies including beta blockers, which were ineffective, and midodrine which caused side effects. She was recently started on Corlanor which has markedly improved her symptomatology and tachycardia. Although primarily used for congestive heart failure (CHF), Corlanor has been used for POTS and inappropriate sinus tachycardia. Although not a first-line indication for POTS, there is significant published data, including a randomized trial on the positive effects of Corlanor in POTS and inappropriate tachycardia syndrome (Page, et al; McDonald, et al; Sheldon, et al). As standard first- and second-line medications have already been tried and the patient continued to have life limiting symptoms or side effects, treatment with Corlanor was reasonable and showed significant clinical improvement. Based on the published data, the failure of other first- and second-line medications, and the excellent clinical response, Corlanor 7.5 mg tablet is medically necessary long-term therapy for this patient and this particular clinical indication. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
A 60-year-old female enrollee has requested reimbursement for air ambulance services provided on 1/13/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.
Overturned
Medical Necessity
Summary Reviewer A 60-year-old female enrollee has requested reimbursement for air ambulance services provided on 1/13/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the air ambulance services provided on 1/13/15 were medically necessary for treatment of the patients medical condition. The patients symptoms represent a neurological emergency that warrants treatment at a hospital with expertise in treating stroke and subarachnoid hemorrhage (SAH). In both conditions, delay in treatment leads to a worse outcome. To expeditiously transfer the patient via air ambulance was a medically reasonable and appropriate action. In the case of a SAH, a quick work-up including potentially an angiogram, magnetic resonance imaging, and access to a neurosurgeon is critical and potentially lifesaving. In the case of an ischemic stroke, a delay of 40 minutes would have reduced the potential effectiveness of tissue plasminogen activator (TPA). The original treating facilities did not feel equipped to manage the case; thus a transfer was medically necessary. Transfer by ambulance would have delayed care and potentially placed the patient at risk of death or longstanding functional disability. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
0
The patient is a 20-year-old male with a diagnosis of overactive bladder, insomnia, and anxiety. The patients associated symptoms include urinary frequency and nocturia. Prior treatment has included overactive bladder anticholinergics and Myrbetriq. The patient has requested reimbursement for percutaneous tibial nerve stimulation (PTNS) provided on 10/16/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational.
Upheld
Experimental
Summary Reviewer 1 The patient is a 20-year-old male with a diagnosis of overactive bladder, insomnia, and anxiety. The patients associated symptoms include urinary frequency and nocturia. Prior treatment has included overactive bladder anticholinergics and Myrbetriq. The patient has requested reimbursement for percutaneous tibial nerve stimulation (PTNS) provided on 10/16/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational. As noted in the medical literature, treatment in this clinical setting should including behavioral therapies with bladder training, bladder control strategies, pelvic floor muscle training, and fluid management as first-line therapy. Behavioral therapies may be combined with pharmacologic management. Overall, the guidelines suggest that PTNS is not recommended as a first- or second-line therapy and PTNS has not been proven to be superior to other alternatives. Thus, the PTNS provided on 10/16/17 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 service at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 22-year-old female enrollee has requested authorization and coverage for spine nerve treatment, procedure codes 64634 and 64633. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. . Per the provider notes the patient has had significant relief with prior radiofrequency of the thoracic facet.
Overturned
Experimental
Summary Reviewer 3 A 22-year-old female enrollee has requested authorization and coverage for spine nerve treatment, procedure codes 64634 and 64633. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that spine nerve treatment, procedure codes 64634 and 64633 are likely to be more beneficial for treatment of the enrollees medical condition. The majority of peer-reviewed literature supports the efficacy of radiofrequency neurolysis in the treatment of chronic spinal pain due to facet pathology as long as the patients are appropriately selected. Tzaan and colleagues performed a retrospective study to assess the value of percutaneous radiofrequency facet rhizotomy. The authors concluded that the procedure is simple and safe in patients with disabling spinal pain that fail to respond to conservative treatment. In this case, the physical exam and MRI is significant for multi-level spondylosis and facet mediated pain. Per the provider notes the patient has had significant relief with prior radiofrequency of the thoracic facet. Therefore, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 54-year-old male enrollee has requested authorization and coverage for Repatha. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee who has been assessed with cardiovascular disease. The patient has been diagnosed with hyperlipidemia with no documented clinical cardiovascular events or significant carotid stenosis. The records do document intolerance to one statin medication (simvastatin).
Upheld
Medical Necessity
Summary Reviewer A 54-year-old male enrollee has requested authorization and coverage for Repatha. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee who has been assessed with cardiovascular disease. The physician reviewer found that the documentation provided does not support the requested medication in this clinical setting. The patient has been diagnosed with hyperlipidemia with no documented clinical cardiovascular events or significant carotid stenosis. The records do document intolerance to one statin medication (simvastatin). Repatha (evolocumab) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor studied in and approved only for patients with heterozygous familial hypercholesterolemia or for patients with documented clinical atherosclerotic heart disease who require additional lowering of LDL-cholesterol (Sabatine, et al; Robinson, et al). The records submitted do not support the criteria as outlined by the literature. Studies are lacking to support the use of PCSK9 inhibitors in other patient populations such as this patient. In addition, current guidelines that are endorsed by several national organizations do not recommend the use of PCSK9 inhibitors in this primary prevention setting (Stone, et al). All told, Repatha is not medically necessary for the treatment of this patient. Therefore, based on the above, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
1
A 43-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/8/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts. that this patient is a 43-year-old female who had a bilateral screening mammogram with tomosynthesis on 8/8/16. There were scattered fibroglandular elements in both breasts. The impression was negative. The patient requested reimbursement for the breast tomosynthesis performed on 8/8/16. The Health Insurer denied the request for reimbursement. Per the Health Insurer, the service at issue was investigational for the evaluation of this patient.
Overturned
Experimental
Summary Reviewer 1 A 43-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/8/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts. The physician reviewer found that this patient is a 43-year-old female who had a bilateral screening mammogram with tomosynthesis on 8/8/16. There were scattered fibroglandular elements in both breasts. The impression was negative. The patient requested reimbursement for the breast tomosynthesis performed on 8/8/16. The Health Insurer denied the request for reimbursement. Per the Health Insurer, the service at issue was investigational for the evaluation of this patient. The medical literature supports breast tomosynthesis in this clinical setting. Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues state that integrated two dimensional and three dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. Thus the literature supports the use of digital breast tomosynthesis over conventional mammogram due to improved cancer detection rate. In sum, digital breast tomosynthesis performed on 8/8/16 was likely to have been superior to other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 49-year-old male enrollee has requested authorization and coverage for Simponi injections 50 mg/0.5 mL. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees rheumatoid arthritis.
Overturned
Medical Necessity
Summary Reviewer A 49-year-old male enrollee has requested authorization and coverage for Simponi injections 50 mg/0.5 mL. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees rheumatoid arthritis. The physician reviewer found that there is sufficient support for the requested medication in this clinical setting. Simponi has been recommended along with the other anti-tumor necrosis factor agents by the American College of Rheumatology for the treatment of rheumatoid arthritis. Based on a double-blind, randomized, placebo-controlled study by Bingham and colleagues, golimumab-treated patients had significantly greater improvements in the signs and symptoms of rheumatoid arthritis through week 24 when compared with placebo, with some patients experiencing a rapid onset of response as early as two weeks after initiating golimumab therapy, and efficacy was maintained through one year. Current peer-reviewed medical studies have established the safety and efficacy of Simponi for the management of rheumatoid arthritis symptoms. As such, Simponi injections 50 mg/0.5 mL is medically necessary for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
The patient is a 52-year-old male who has been diagnosed with spondylosis without myelopathy or radiculopathy, lumbar region; other intervertebral disc degeneration, lumbar; and low back pain. The patient has requested authorization and coverage for the Intracept procedure. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
Upheld
Medical Necessity
Summary Reviewer The patient is a 52-year-old male who has been diagnosed with spondylosis without myelopathy or radiculopathy, lumbar region; other intervertebral disc degeneration, lumbar; and low back pain. The patient has requested authorization and coverage for the Intracept procedure. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that according to the U.S. Food and Drug Administration (FDA) Indications for Use, The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). There is a lack of support for the requested services in this patients case. FDA criteria would only have been plausibly met if the patient had chronic low back pain generators that had been clearly delineated as being linked to the spinal vertebral body(s) in origin. In this case, there were/are multiple plausible pathologic sources of significant pain generation. These included the documented tender trigger points (clinically associated with a peri-spinal soft tissue origin) and the tender facet joints (the portion of the spinal vertebrae dorsal to the vertebral bodies themselves). The non-radiating midline back pain, the noted pain-aggravating and pain-relieving factors, along with the diminished and painful spinal motion (in all directions) and intact neurologic examination were/are all non-specific to any pathologic entities. Overall, documentation is lacking regarding reasonably detailed and/or evidenced findings supportive of the spinal vertebral bodies as being the overwhelming primary generators of the patients chronic persistent pain. The records do not support actual formal surgical ablation of pre-designated basivertebral nerves as being medically necessary and/or reasonable at this time. Therefore, the requested Intracept procedure is not medically necessary for the treatment of this patient.
1
A 60-year-old female enrollee has requested authorization and coverage for 22870 and 22869 (insertion of stabilization device without compression). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. In this case, the patient is being treated for chronic low back pain with radiation to bilateral lower extremities.
Upheld
Experimental
Summary Reviewer 2 A 60-year-old female enrollee has requested authorization and coverage for 22870 and 22869 (insertion of stabilization device without compression). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the interspinous process decompression offers an intermediate step in the continuum of care for patients with neurogenic intermittent claudication associated with lumbar spinal stenosis. There are many interspinous devices on the market; however, the devices lack high-quality research to demonstrate safety that is better than the current standard of care, simple decompression. Coupling surgical decompression techniques with the use of interspinous devices has added confusion to the contribution of interspinous devices in pain/symptom relief. In this case, the patient is being treated for chronic low back pain with radiation to bilateral lower extremities. There is insufficient evidence to support the use of interspinous devices for the treatment of spinal stenosis with neurogenic claudication versus decompression alone. All told, the requested CPT codes 22869 and 22870 (insertion of stabilization device without decompression) are not likely to be more beneficial for treatment of the patients medical condition than any standard therapy.
1
The parent of a 15-year-old male enrollee has requested reimbursement for procalcitonin testing. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. this patients case, there was a readily accessible infection at the extensor surface of the elbow accessible to palpation and with white blood cell count monitoring and C-reactive protein monitoring.
Upheld
Experimental
Summary Reviewer 3 The parent of a 15-year-old male enrollee has requested reimbursement for procalcitonin testing. 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 level of procalcitonin in the blood rises in response to a pro-inflammatory stimulus, especially of bacterial origin. It does not respond significantly to viral or non-infectious inflammations. Measurement of procalcitonin can be used as a marker of severe sepsis, with a level of sensitivity of 85% and specificity of 91% in differentiating systemic inflammatory response syndrome from sepsis. However, there is a lack of support for the services at issue in this clinical setting. In this patients case, there was a readily accessible infection at the extensor surface of the elbow accessible to palpation and with white blood cell count monitoring and C-reactive protein monitoring. The presence of bacterial infection and the need for incision and drainage is a decision which may be made without obtaining this additional biometric. Thus, procalcitonin level was not likely to have been of greater benefit than other modalities. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 64-year-old female enrollee has requested reimbursement for the Decision DX Melanoma assay performed on 6/16/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 2 A 64-year-old female enrollee has requested reimbursement for the Decision DX Melanoma assay performed on 6/16/15. 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 the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The patient presents with Stage I melanoma, with no adverse prognostic features. In this clinical setting, adjuvant therapy is only indicated for patients with node positive disease. Further studies are needed to assess Decision DX Melanoma assay and how the results will be incorporated into staging and ultimately treatment. The standard therapy for a Stage I melanoma is wide excision. In addition, the American Joint Committee on Cancer (AJCC) does not recommend Decision DX Melanoma assay in this clinical setting. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
0
A 57-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 12/17/15 and 1/12/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk for breast cancer.
Overturned
Experimental
Summary Reviewer 2 A 57-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 12/17/15 and 1/12/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that tomosynthesis was approved for clinical use by the U.S. Food and Drug Administration (FDA) in 2011. Despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of screening mammography the American College of Radiology (ACR) supports the utility of tomosynthesis, especially in patients with extremely or heterogeneously dense tissue such as the patient under this review. This technique often allows the reader to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in biopsies, decrease in callbacks and increase in detection of small cancers. Thus, on the screening exam of 12/17/15, the addition of tomosynthesis to the usual two dimensional views was likely of more benefit to the patient than had the exam been done with two dimensional technique alone. However, the follow-up left diagnostic mammogram on 1/12/16 was for the purpose of characterization of the detected left breast calcifications. These calcifications required magnification spot views in 90 degree orthogonal planes and not a repeat tomosynthesis. It is unlikely that such a repeat tomosynthesis view added anything in addition to the information available on the magnification views. Accordingly, the breast tomosynthesis provided on 12/17/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy while the study performed on and 1/12/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, a portion of 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 partially overturned.
1
A 49-year-old transgender female enrollee has requested reimbursement for facial feminization procedure provided on 3/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gender dysphoria. . This patient has been diagnosed with gender dysphoria, and the records noted social anxiety and depression. The records documented distress related to masculine facial features as well as distress regarding being perceived as male by others.
Overturned
Medical Necessity
Summary Reviewer A 49-year-old transgender female enrollee has requested reimbursement for facial feminization procedure provided on 3/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gender dysphoria. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. This patient has been diagnosed with gender dysphoria, and the records noted social anxiety and depression. The records documented distress related to masculine facial features as well as distress regarding being perceived as male by others. For patients with gender dysphoria, facial feminization surgery is medically necessary in the setting of clinically significant distress or functional impairment. World Professional Association for Transgender Health (WPATH) criteria for surgery state that surgical procedures for patients with gender dysphoria may include augmentation mammoplasty, genital surgery and other interventions, such as facial feminization surgery, liposuction, lipofilling and thyroid cartilage reduction. Thus, the current medical evidence supports the services at issue in this clinical setting. In sum, facial feminization procedure provided on 3/26/18 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.
1
A 45-year-old female enrollee has requested reimbursement for inpatient mental health treatment from 2/08/16 through 2/11/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. In this case, the patient was suffering from an extraordinarily severe mental illness. The treating psychiatrist determined that the patients symptom complex could not be managed at a lower level of care. She had a prominent illness burden and abysmal insight. She had limited social support. She required long-term specialty care and there was
Overturned
Medical Necessity
Summary Reviewer A 45-year-old female enrollee has requested reimbursement for inpatient mental health treatment from 2/08/16 through 2/11/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found modern psychiatric practice aims to place patients in the least restrictive treatment setting. In general, community intervention settings optimize treatment gains. However, episodic placement in more restrictive settings is often clinically appropriate for those with serious mental illness. In this case, the patient was suffering from an extraordinarily severe mental illness. The treating psychiatrist determined that the patients symptom complex could not be managed at a lower level of care. She had a prominent illness burden and abysmal insight. She had limited social support. She required long-term specialty care and there was reasonable concern that discharge to home would have terminated rather than interrupted the episode of care. The treatment was safe, appropriate and reasonably expected to prevent a worsening of illness. All told, inpatient mental health treatment from 2/08/16 through 2/11/16 was medically indicated 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 61-year-old female 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 lung cancer.
Overturned
Experimental
Summary Reviewer 2 A 61-year-old female 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 lung cancer. The physician reviewer found that The National Comprehensive Cancer Network (NCCN) has established guidelines for the initial work-up and then treatment and surveillance for small cell lung carcinoma. The initial work-up will often include, among other modalities, a PET/CT scan. When there is evidence of a new nodule or mass, the NCCN recommends that the patient be re-evaluated as if the new mass could be a new primary tumor. This initial evaluation would likely include a PET/CT scan. In this patients case, PET scan is likely to alter management. If the PET scan were to show metabolic activity, it is likely that the patient will undergo another round of chemotherapy. A strikingly high standardized uptake value (SUV) will indicate tumor. All told, the requested PET scan is likely to be superior over 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.
1
A 29-year-old female enrollee has requested reimbursement for the inpatient admission services provided from 4/27/17 through 4/28/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees lymphadenopathy.
Upheld
Medical Necessity
Summary Reviewer A 29-year-old female enrollee has requested reimbursement for the inpatient admission services provided from 4/27/17 through 4/28/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees lymphadenopathy. The physician reviewer found that this patients records did not document emergency or life threatening signs or symptoms that necessitated a hospital admission. The patients history, physical examination, laboratory or radiographic evaluation did not indicate the patient was in imminent danger, acutely ill, or medically unstable. For this reason, the work-up could have been performed on an outpatient basis. Accordingly, the inpatient admission services provided from 4/27/17 through 4/28/17 were not medically necessary for treatment of the patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
0
A 43-year-old transgender female enrollee has requested authorization and coverage for electrolysis epilation, each 30 minutes. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees gender dysphoria. , the patient is well-documented to have gender dysphoria; thus, her She has transitioned into living as a female since she began hormone therapy in 2013.
Overturned
Medical Necessity
Summary Reviewer A 43-year-old transgender female enrollee has requested authorization and coverage for electrolysis epilation, each 30 minutes. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees gender dysphoria. The physician reviewer found the requested services are within accepted standard of practice and clinically appropriate for treatment of this patients gender dysphoria. In this case, the patient is well-documented to have gender dysphoria; thus, her external anatomy should be more consistent with a female than a male. She has transitioned into living as a female since she began hormone therapy in 2013. The requested epilation hair removal can provide substantial improvement in the appearance of terminal hair and create as normal an appearance as possible. Moreover, the requested treatment may improve emotional function in this patient. It would create a more feminine genital or extremity appearance. The medical literature support the services at issue for treatment of gender dysphoria. Therefore, for the reasons stated above, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
The patient is a 55-year-old male who was hospitalized from 6/08/20 through 6/11/20. The patient has requested reimbursement for air ambulance services provided on 6/11/20.
Overturned
Medical Necessity
Summary Reviewer The patient is a 55-year-old male who was hospitalized from 6/08/20 through 6/11/20. The patient has requested reimbursement for air ambulance services provided on 6/11/20. The physician reviewer found that in order for air medical transport to be medically necessary, all medical necessity criteria must be met. These criteria include: the individualas condition must be such that any form of transportation other than ambulance would be medically contraindicated; the individualas condition is such that time needed to transport by ground poses a threat to the patientas survival; the individual is transported to the nearest hospital with appropriate facilities for treatment; and there is a medical condition that is life-threatening. When transporting from one facility to another, the above criteria must be met, and the first hospital does not have the required services and facilities to treat the patient. The patientas provider noted that El Centro Regional Medical Center does not have an intensivist available to help manage an intubated patient and that was the reason for transfer to Cedar Sinai. It appears from this provideras note that Cedar Sinai was the closest available facility with an intensive care unit (ICU) available capable of accepting the patient. Therefore, air ambulance services provided on 6/11/20 were medically necessary for the treatment of this patient.
1
A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/15/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees breast examination.
Overturned
Experimental
Summary Reviewer 3 A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/15/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees breast examination. The physician reviewer found in recent years, several studies support the use of breast tomosynthesis as a more accurate study than routine screening mammography. Medical literature supports the use of breast tomosynthesis over conventional mammogram due to improved cancer detection rate. As noted in a paper by Helvie and colleagues, this technology has the potential to change conventional mammographic screening and diagnostic imaging with possible improvements in cancer detection, decreased callbacks, and fewer false positive biopsies. In this particular patient, as discussed by Kopans and colleagues, tomosynthesis is valuable in the evaluation and optimizing visualization of suspicious breast calcifications. Thus, the submitted documentation supports the service at issue in this clinical setting as tomosynthesis was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 66-year-old male enrollee has requested authorization and coverage for Repatha Sureclick. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. patient presents with some coronary risk, including hyperlipidemia, but no documented clinical cardiovascular disease.
Upheld
Medical Necessity
Summary Reviewer A 66-year-old male enrollee has requested authorization and coverage for Repatha Sureclick. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient presents with some coronary risk, including hyperlipidemia, but no documented clinical cardiovascular disease. Coronary calcification does not equal coronary stenosis. Repatha (evolocumab) is a proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitor studied in and approved for patients with heterozygous familial hypercholesterolemia or for patients with documented clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol. This patient does not fit either of those criteria. There is no documentation to support a history of homozygous familial hypercholesterolemia or heterozygous hypercholesterolemia. These diagnoses require not only elevated LDL levels that significantly exceed 180 mg/dl but also a combination of physical examination findings (arcus cornealis below the age of 45, tendon xanthomata), a strong family history of coronary disease (younger than 50 years in second-degree relative or aged younger than 55 years in first-degree relatives) and documented genetic defects related to cholesterol metabolism according to published criteria. There is a lack of documentation to confirm the presence of obstructive coronary or vascular disease. Repatha has not been adequately studied in the setting of primary prevention in patients with increased coronary risk but no evidence of clinical obstructive cardiovascular disease, such as this patient. Current guidelines that are endorsed by several national organizations also do not recommend the use of PCSK9 inhibitors in this primary prevention setting. Therefore, Repatha SureClick is not medically necessary for the treatment of this patient.
1
A 41-year-old male enrollee has requested authorization and coverage for myoelectric, upper extremity orthosis. The Health Insurer has denied this request indicating that the requested equipment is considered investigational for treatment of the enrollee who had sustained an injury to his upper right arm. The physician that the patient is a 41-year-old male who sustained a right brachial plexus injury in December 2014. He underwent nerve and tendon grafting in July 2015 and February 2016 with less than expected recovery. He has a three out of five strength to his right hand and two out of five strength in his right shoulder and elbow. A Wilmer carrying orthosis has been utilized for static splinting but affords no functional benefit. Prior to the accident this patient was independent with all activities but he currently requires assistance with activities of daily living (ADL). The patient requested authorization and coverage for myoelectric, upper extremity orthosis. The Health Insurer denied the requested equipment as investigational for treatment of the patients medical condition. has exhausted several conservative options including splinting, orthoses, therapy, and surgical nerve and tendon transfer.
Overturned
Experimental
Summary Reviewer 1 A 41-year-old male enrollee has requested authorization and coverage for myoelectric, upper extremity orthosis. The Health Insurer has denied this request indicating that the requested equipment is considered investigational for treatment of the enrollee who had sustained an injury to his upper right arm. The physician reviewer found that the patient is a 41-year-old male who sustained a right brachial plexus injury in December 2014. He underwent nerve and tendon grafting in July 2015 and February 2016 with less than expected recovery. He has a three out of five strength to his right hand and two out of five strength in his right shoulder and elbow. A Wilmer carrying orthosis has been utilized for static splinting but affords no functional benefit. Prior to the accident this patient was independent with all activities but he currently requires assistance with activities of daily living (ADL). The patient requested authorization and coverage for myoelectric, upper extremity orthosis. The Health Insurer denied the requested equipment as investigational for treatment of the patients medical condition. The medical literature supports the superior efficacy of the requested equipment, in this clinical setting. The custom myoelectric elbow wrist orthosis will allow greater benefit than the standard static orthosis that this patient is currently utilizing. There are multiple studies proving the benefit of myoelectric orthoses for a plegic upper extremity. In a study by Ogce and Ozyalcin, they document the benefits of a myoelectrically controlled shoulder-elbow orthosis for brachial plexus injury. In this patients case, he has exhausted several conservative options including splinting, orthoses, therapy, and surgical nerve and tendon transfer. The myoelectric orthosis has been shown to improve function in a plegic extremity. The equipment would allow elbow flexion and extension with an articulated wrist. Moreover, this equipment would facilitate independence with ADL, in this case. Currently, the patient requires assistance with his ADL. As such, the requested myoelectric, upper extremity orthosis, is likely to be more effective than the standard options available for treatment of this patient. Based upon the information set forth above, the requested equipment 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
patient is a 53-year-old female. In a letter dated 12/13/22, the provider reported that the patient was diagnosed in April 2022 with primary melanoma of the cervix with an erythroblastic oncogene B (ERBB)2 V777L mutation.). The patient has requested authorization and coverage for Tukysa (tucatinib) 150 mg #120/30 days. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.
Upheld
Medical Necessity
Summary The patient is a 53-year-old female. In a letter dated 12/13/22, the provider reported that the patient was diagnosed in April 2022 with primary melanoma of the cervix with an erythroblastic oncogene B (ERBB)2 V777L mutation.). The patient has requested authorization and coverage for Tukysa (tucatinib) 150 mg #120/30 days. 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 does not support the medical necessity of the requested medication. The use of Tukysa (generic name tucatinib) is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of melanoma, nor is it supported by the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of cutaneous melanoma or major drug compendia. While Gottesdiener and colleagues note that there is some limited data to support the use of other HER2 treatment such as trastuzumab ematansine, given that current medical literature does not support the use of Tukysa for ERBB2 related melanoma, the requested medication is not medically indicated. Therefore, Tukysa (tucatinib) 150 mg #120/30 days is not medically necessary for the treatment of this patient.
1
A 66-year-old female enrollee has requested authorization and coverage for ablation of varicose veins, right and left accessory ablation. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. in this case, the patient has already undergone great saphenous vein removal. The reflux from the incompetent saphenofemoral junctions is now going down the accessory saphenous veins. These veins are very large, and have free reflux. They are essentially acting as refluxing greater saphenous veins.
Overturned
Experimental
Summary Reviewer 1 A 66-year-old female enrollee has requested authorization and coverage for ablation of varicose veins, right and left accessory ablation. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that in this case, the patient has already undergone great saphenous vein removal. The reflux from the incompetent saphenofemoral junctions is now going down the accessory saphenous veins. These veins are very large, and have free reflux. They are essentially acting as refluxing greater saphenous veins. In the situation where these veins can be ablated, this treatment is standard of care. All told, the requested ablation of varicose veins, right and left accessory ablation is likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 37-year-old female enrollee has requested reimbursement for gene testing provided on 9/16/15. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees breast cancer.
Upheld
Experimental
Summary Reviewer 1 A 37-year-old female enrollee has requested reimbursement for gene testing provided on 9/16/15. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees breast cancer. The physician reviewer found that Foundation One testing offers a comprehensive panel of molecular genetic markers on an individuals tumor with the hopes of identifying markers than can help guide therapy decision making. The National Comprehensive Cancer Network (NCCN) guidelines have not been determined if molecular markers are useful in treatment determination and prognosis other than those established markers for breast cancer such as ER, PR and HER2. There is currently a phase II clinical trial underway that is evaluating the efficacy of genetic molecular testing to guide individual therapy. Given the lack of definitive support in the peer-reviewed literature, the gene testing provided on 9/16/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 48-year-old female has requested reimbursement for Anser IFX testing performed on 9/04/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns colitis.
Upheld
Experimental
Summary Reviewer 3 A 48-year-old female has requested reimbursement for Anser IFX testing performed on 9/04/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns colitis. The physician reviewer found the use of Anser IFX to direct management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials of patients with Crohns disease. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have clear Remicade levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. Although loss of response to infliximab is common, there were a lack of standard guidelines defining a therapeutic strategy at the time of testing. Based on the medical literature, Anser IFX testing performed on 9/04/15 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.
1
A 24-year-old male enrollee has requested reimbursement for office visits, acupuncture and physical therapy provided from 11/05/18 through 2/01/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. than a back sprain/strain injury with persistent mechanical low back pain,
Upheld
Medical Necessity
Summary Reviewer A 24-year-old male enrollee has requested reimbursement for office visits, acupuncture and physical therapy provided from 11/05/18 through 2/01/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the records do not indicate that the patient had a condition other than a back sprain/strain injury with persistent mechanical low back pain, with possible radiculitis. These are conditions that heal spontaneously, and symptoms generally improve over time with relative rest and palliative measures, as needed. Palliative measures can form a mainstay of treatment for those with significant persistent symptoms, but no marginal objective benefit in course or outcomes would be expected with formal interventions (including acupuncture, infrared therapy and manual therapy) over independently applied measures, such as topical heat, foam rolling, over the counter analgesics, education and reassurance. Secondary preventive measures, such as education with regards to exercise and lifting technique, can be employed by understanding the specific details regarding how the patient may have sustained the original back injury and, thereby, implementing appropriate measures to mitigate risk of re-injury. In this case, there was insufficient documented history with regards to the specifics of his exercise program. Only exercise time exposure characteristics for his type of exercise (weightlifting) are described. Otherwise, generalized measures, such as strengthening the core and staying active with exercise, could have been pursued. The medical evidence does not support the services at issue in this clinical setting. Therefore, office visits, acupuncture and physical therapy provided from 11/05/18 through 2/01/19 were not medically necessary for the treatment of this patient.
1
A 58-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus.
Overturned
Medical Necessity
Summary Reviewer A 58-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per guidelines, Harvoni is first-line therapy for treatment-naive genotype 1 patients. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). AASLD guidelines also cite data showing increased survival with earlier treatment (Jezequel, et al). For these reasons, Harvoni should be approved as medically necessary based on national guidelines. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
The patient is a 57-year-old female with a history of left knee pain. The patient has requested authorization and coverage for left knee arthroscopy with partial meniscectomy and chondroplasty. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. In this case, the patient has documented degenerative changes in the medial articular surface of the patella and trochlea. The two reported tears are small and involve the inferior aspect of the medial meniscus in the posterior horn and the body.
Upheld
Medical Necessity
Summary Reviewer The patient is a 57-year-old female with a history of left knee pain. The patient has requested authorization and coverage for left knee arthroscopy with partial meniscectomy and chondroplasty. 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 recent studies have conclusively shown that outcomes after an arthroscopic partial meniscectomy are no better than the outcomes after a sham/placebo surgery. Meniscal repair is now being touted as a viable and effective alternative. However, meniscal repairs depend upon the location of tear in the peripheral red zone of the meniscus. Meniscal repairs have been proven to be a much more efficient alternative to partial meniscectomy. It is now increasingly recommended to attempt meniscal repair in all repairable tears, especially in young and physically active patients. Partial meniscal implants have also shown excellent outcomes in long-term studies, but its efficacy in acute settings still requires further research. Research in regenerative medicine also looks promising for the meniscal tissue. In this case, the patient has documented degenerative changes in the medial articular surface of the patella and trochlea. The two reported tears are small and involve the inferior aspect of the medial meniscus in the posterior horn and the body. These are likely degenerative in nature. There are no mechanical symptoms documented, and the tears are stable. Focal cartilage lesions seen on MRI, such as fissuring in this case, warrant a trial of conservative treatment, such as physical therapy, home exercise program, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections or viscosupplementation, which has not been documented. Furthermore, the location of pain has not been documented to be anterior, and so it is not known if patellar chondromalacia is the pain generator. Chondroplasty has short-term efficacy for pain relief and may be done as a part of the arthroscopic procedure of partial meniscectomy, which is not indicated for the aforementioned reasons. Therefore, the requested left knee arthroscopy with partial meniscectomy and chondroplasty is not medically necessary for the treatment of this patient.
1
A 58-year-old female enrollee has requested authorization and coverage for a left total knee arthroplasty. 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. records document chronic left knee pain due to severe osteoarthritis. The arthritis is tricompartmental, with the medial compartment being bone-on-bone. She has severe pain with ambulation and also complains of nocturnal pain interfering with sleep. The provider has documented trial/failure of conservative treatment for several years. On examination, there is a varus deformity. The provider has opined that the patient is a good candidate for outpatient total knee arthroplasty.
Overturned
Medical Necessity
Summary Reviewer A 58-year-old female enrollee has requested authorization and coverage for a left total knee arthroplasty. 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 records document chronic left knee pain due to severe osteoarthritis. The arthritis is tricompartmental, with the medial compartment being bone-on-bone. She has severe pain with ambulation and also complains of nocturnal pain interfering with sleep. The provider has documented trial/failure of conservative treatment for several years. On examination, there is a varus deformity. The provider has opined that the patient is a good candidate for outpatient total knee arthroplasty. In reviewing the medical records, the patient does meet the criteria for a successful outpatient total knee arthroplasty. Her age, activity status, degree of pain, nocturnal symptoms, failure of conservative treatment, and radiographic criteria of severe osteoarthritis of the medial compartment and lesser degree of osteoarthritis in the remaining compartments, all meet the guidelines for a successful total knee arthroplasty. The providers request for an outpatient total knee arthroplasty is supported by the medical literature. Therefore, the requested left total knee arthroplasty is medically necessary for the treatment of this patient.
1
A 57-year-old male enrollee has requested authorization and coverage for Euflexxa injections. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees osteoarthritis of the bilateral knees. the patient has osteoarthritis of the bilateral knees. The patient has been treated with Euflexxa injections and reported relief from 2011 until 2014.
Overturned
Medical Necessity
Summary Reviewer A 57-year-old male enrollee has requested authorization and coverage for Euflexxa injections. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees osteoarthritis of the bilateral knees. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity of the requested services. Axe and colleagues report that intra-articular (IA) viscosupplementation using hyaluronic acid (HA) demonstrates anti-inflammatory, anabolic, and analgesic effects. The authors state Use of IA HA has also shown to delay total knee arthroplasty. Moreover, the literature review by Cheng and colleagues state We conclude that strong evidence supports the use of intra-articular knee injection as a valuable intervention in the continuum of management of arthritis between conservative treatment and knee surgeries. In this case, the clinical documentation submitted for review indicates the patient has osteoarthritis of the bilateral knees. The patient has been treated with Euflexxa injections and reported relief from 2011 until 2014. As such, additional injections would be medically necessary in this clinical setting. Based on the medical records submitted and the peer-reviewed literature, the request for Euflexxa injections are medically necessary for the treatment of the patients medical condition. For the reasons provided, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
A 38-year-old male enrollee has requested authorization and coverage for a cardioverter defibrillator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollee, who has cardiac sarcoidosis.
Overturned
Experimental
Summary Reviewer 1 A 38-year-old male enrollee has requested authorization and coverage for a cardioverter defibrillator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollee, who has cardiac sarcoidosis. The physician reviewer found that Cardioverter defibrillator implantation is a Class IIa recommendation in patients with cardiac sarcoid, independent of ventricular function, if there is an indication for permanent pacemaker implantation. In this patients case, given the symptomatic bradycardia due to intermittent second degree heart block, a permanent pacemaker is indicated. Therefore, an implantable cardioverter defibrillator is indicated. This is due to the increased risk for sudden cardiac death with this type of cardiomyopathy. Therefore, the requested cardioverter defibrillator is likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 19-year-old male enrollee has requested authorization and coverage for lumbar disc arthroplasty and two inpatient days. 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 a large disc protrusion causing severe central canal and right lateral recess stenosis, with no prior surgeries.
Upheld
Experimental
Summary Reviewer 2 A 19-year-old male enrollee has requested authorization and coverage for lumbar disc arthroplasty and two inpatient days. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the medical evidence does not support the requested services in this clinical setting. This patient has a large disc protrusion causing severe central canal and right lateral recess stenosis, with no prior surgeries. The most straightforward and lowest risk operation indicated is for a posterior decompression procedure (lumbar laminotomy versus laminectomy and a microdiscectomy). A lumbar arthroplasty is not indicated as the initial operation for a disc herniation causing central and lateral recess stenosis. Central stenosis and lateral recess stenosis, resulting in single nerve root compression, are listed as contraindications to lumbar disc arthroplasty in the published literature according to the referenced U.S. Food and Drug Administration (FDA) ProDisc patient insert. Therefore, the requested lumbar disc arthroplasty and two inpatient days are not likely to be more beneficial than any available standard therapy.
1
SERT FIRST TWO SENTENCES FROM SUMMARY REVIEW DETERMINATION]
Overturned
Experimental
Summary Reviewer 3 [INSERT FIRST TWO SENTENCES FROM SUMMARY REVIEW DETERMINATION] The physician reviewer found that Ttansanal hemorrhoidal dearterialization is an option for the treatment of grade II and III internal hemorrhoids in patients that have failed non operative treatment. However, randomized trials have failed to consistently demonstrate significant benefits of this therapy alternative surgical procedures. Although there is data to show that transanal hemorrhoidal dearterialization is a safe and effective method of surgically treating hemorrhoids, there is a lack of clinical trials reporting benefits of transanal hemorrhoidal dearterialization over standard treatment options. Thus, the Doppler guided transanal hemorrhoidal dearterialization provided on 11/20/17 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.
1
An 18-year-old male enrollee has requested reimbursement for mental health intensive outpatient program (IOP) services provided from 12/16/15 through 1/18/16. 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. . In this case, the patient has a history of depression, OCD with prior suicide attempts one of which was serious as the only reason for its failing was the failure of the apparatus. Per the individual session note dated 1/8/16 the patient reported to being very depressed and feeling alone. During the dates in dispute the patient required continued supportive services with individual, family and group therapies prior to discharge into the community.
Overturned
Medical Necessity
Summary Reviewer An 18-year-old male enrollee has requested reimbursement for mental health intensive outpatient program (IOP) services provided from 12/16/15 through 1/18/16. 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 the services at issue were medically necessary for treatment of the patients medical condition. The documentation submitted for review supports placement at the IOP level of care. Tamez and colleagues report on the benefits of treating depression in IOP programs particularly if the patient does not require acute hospitalization, but requires additional supportive services prior to fully reintegrating back into the community. In this case, the patient has a history of depression, OCD with prior suicide attempts one of which was serious as the only reason for its failing was the failure of the apparatus. Per the individual session note dated 1/8/16 the patient reported to being very depressed and feeling alone. During the dates in dispute the patient required continued supportive services with individual, family and group therapies prior to discharge into the community. Accordingly, IOP services provided from 12/16/15 through 1/18/16 were medically necessary for treatment of the patients behavioral health condition. Therefore, for the reasons stated above, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
A 33-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) testing provided on 5/30/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of enlarged lymph nodes. The physician that the patient has had a history of enlarged lymph nodes of unknown etiology. She has had a biopsy and blood tests, which were all negative. She had a PCR test Epstein-Barr virus and other organisms. The test results for this patient were normal but she continued to have large lymph nodes.
Upheld
Experimental
Summary Reviewer 2 A 33-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) testing provided on 5/30/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of enlarged lymph nodes. The physician reviewer found that the patient has had a history of enlarged lymph nodes of unknown etiology. She has had a biopsy and blood tests, which were all negative. She had a PCR test Epstein-Barr virus and other organisms. The common testing performed for lymphadenopathy can generally determine the cause of the lymphadenopathy. The test results for this patient were normal but she continued to have large lymph nodes. A PCR test to detect the cause of the lymphadenopathy is within the standard of care to evaluate uncommon etiologies of large lymph nodes such as in this patients case when all standard first step work up have been negative. As such, PCR testing provided on 5/30/17 was likely to have been more effective than the available standard techniques for the evaluation of this patients medical condition. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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).
Upheld
Experimental
Summary Reviewer 2 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 there is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other surgical anti-reflux procedures. One evidence-based review concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined (Sheu and Rattner). Another best-evidence review concluded that further studies are required to determine its long term outcomes and its relative efficacy as compared to other established treatments (Loh, et al). Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval (Bauer, et al). A peer-reviewed journal published a letter stating that there are 11 reports of endoscopically-confirmed LINX erosion through the esophagus in the FDA database (Bielefeldt, et al). Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia requiring endoscopic intervention, which is a concern in this patient (Sheu, et al). The currently available peer-reviewed literature does not definitively support the conclusion that LINX is likely to be more beneficial in this case than standard treatment, surgical fundoplication (Sheu, et al). American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). Therefore, according to current literature and clinical guidelines, LINX is not likely to be more efficacious for treatment of GERD and should be considered investigational.
1
A 61-year-old female enrollee has requested authorization and coverage for Viekira Pak. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C.
Overturned
Medical Necessity
Summary Reviewer A 61-year-old female enrollee has requested authorization and coverage for Viekira Pak. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C. The physician reviewer found according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C, regardless of fibrosis, should be treated except those with limited life expectancy less than 12 months due to non-liver-related comorbid conditions. It is advantageous to treat patients before they progress to cirrhosis. Based on evidence of safety and efficacy in the published literature, and clinical guidelines, Viekira Pak is medically indicated for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
The patient is a 12-year-old male who has been diagnosed with autoimmune encephalitis/encephalopathy and pediatric autoimmune neuropsychiatric disorder associated with streptococcus (PANDAS) following the acute onset of mental health symptoms in 2020. The patients parent has requested reimbursement for GammaGard (IVIG) provided from 9/05/20 through 12/28/20.
Overturned
Medical Necessity
Summary Reviewer The patient is a 12-year-old male who has been diagnosed with autoimmune encephalitis/encephalopathy and pediatric autoimmune neuropsychiatric disorder associated with streptococcus (PANDAS) following the acute onset of mental health symptoms in 2020. The patients parent has requested reimbursement for GammaGard (IVIG) provided from 9/05/20 through 12/28/20. The physician reviewer found that the treatment of PANDAS involves approaching both the physical and psychiatric symptoms. Treatment must reduce the OCDs, the tics or other behaviors that could interfere with day-to-day living and school. The treatment of the streptococcal infection is performed with antibiotics. The psychiatric symptoms can begin to improve upon the start of the antibiotic treatment. The OCD and other psychiatric symptoms are generally treated with the cognitive behavioral therapy and/or selective serotonin reuptake inhibitors. Some severe cases of PANDAS may not respond to drugs and behavioral therapy. IVIG has been described in multiple case reports and case series. The 2018 study by Pavone and colleagues included a cohort of 34 children diagnosed with severe PANDAS. In this cohort, 29 out of 34 of children treated with IVIG showed a reduction or disappearance of the symptomatology, while in five cases (15%), despite three IVIG courses, there was only temporary improvement of clinical symptoms, with their reappearance within one to six months. Limitations of the study included the absence of case controls and long-term follow-up. The 2020 study by Pavone and colleagues included a cohort of 55 children diagnosed with moderate-to-severe PANDAS who were treated with IVIG. The study found a noticeable improvement in symptoms for at least one year for 47 of the 55 patients (85%). While 12 of the patients (21.8%) went from having extreme symptoms to having no symptoms, 22 of the patients (40%) went from having extreme symptoms to having mild symptoms. In 11 patients (20%), only one treatment of IVIG was required, while 36 patients (65.5%) required a second course of treatment. A multi-site open label study by Melamed and colleagues consisted of 21 subjects (7 per site) with moderate-to-severe PANS. The mean age was 10.86 years. Results demonstrated statistically significant reductions in symptoms from baseline to end of treatment in all six assessments measured. Furthermore, the National Institute of Mental Health NIMH states on their website, Plasma exchange or immunoglobulin (IVIG) may be a consideration for acutely and severely affected children with PANDAS. Research suggests that both active treatments can improve global functioning, depression, emotional ups and downs, and obsessive-compulsive symptoms...the treatments should be reserved for severely ill patients and administered by a qualified team of health care professionals. Additionally, first- line therapeutic agents used to treat autoimmune encephalitis include IVIG. This patient has been diagnosed with PANS/PANDAS and autoimmune encephalitis/encephalopathy and has not responded to other treatments, including psychotropic medications and steroids. Records report that he has had a positive response to IVIG. There is sufficient evidence in the medical literature and in the clinical response of the patient to support the use of IVIG. Therefore, GammaGard (IVIG) provided from 9/05/20 through 12/28/20 was medically necessary for the treatment of this patient.
1
A 43-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/8/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts. that the patient is a 43-year-old asymptomatic female who was evaluated with screening mammogram and digital breast tomosynthesis on 8/8/16. This study revealed no evidence of malignancy. The Health Insurer has denied reimbursement of digital breast tomosynthesis performed on 8/8/16. Per the Health Insurer, the service at issue was investigational for the evaluation of this patient.
Overturned
Experimental
Summary Reviewer 2 A 43-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/8/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts. The physician reviewer found that the patient is a 43-year-old asymptomatic female who was evaluated with screening mammogram and digital breast tomosynthesis on 8/8/16. This study revealed no evidence of malignancy. The Health Insurer has denied reimbursement of digital breast tomosynthesis performed on 8/8/16. Per the Health Insurer, the service at issue was investigational for the evaluation of this patient. There is evidence based support for the service at issue in this clinical setting. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in callbacks and biopsies and an increase in detection of small cancers when compared to two dimensional imaging alone. Breast tomosynthesis provides advantages to radiologists interpreting mammograms. Therefore, the addition of digital breast tomosynthesis, to the usual two dimensional protocol on 8/8/16 was likely to be more effective than had the patients examination been performed using two dimensional imaging alone. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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 medical records provided for review report a condition of chronic pain with diagnosis of small fiber neuropathy (biopsy proven) with a history of chemotherapy for breast cancer.
Upheld
Experimental
Summary Reviewer 2 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. The medical records provided for review report a condition of chronic pain with diagnosis of small fiber neuropathy (biopsy proven) with a history of chemotherapy for breast cancer. The medical records also report complex regional pain syndrome (CRPS), but the documentation submitted for review does not detail specific information in support of this diagnosis. The medical records report failure of interventional, physical and psychological modalities, but the documentation does not detail the particular treatments or duration of those treatments in support that all standard treatments have not helped. Kosharskyy and colleagues note that ketamine infusions may have benefit for CRPS; however there is insufficient evidence in regards to neuropathy related pain. In addition, there is a lack of medical literature of standardized dosing regimen or duration of such therapy in regard to peripheral neuropathy/small fiber neuropathy pain. All told, the peer reviewed literature does not support ketamine infusion as likely to be more beneficial for treatment of the patients medical condition than other modalities for the treatment of peripheral neuropathy related pain. 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
The patient is a 56-year-old male who presented to his provider on 1/6/22. The patient has requested authorization and coverage for aprepitant 80 mg.
Overturned
Medical Necessity
Summary Reviewer The patient is a 56-year-old male who presented to his provider on 1/6/22. The patient has requested authorization and coverage for aprepitant 80 mg. The physician reviewer found that at issue is whether aprepitant 80 mg is medically necessary for the treatment of this patient. The submitted documentation supports the medical necessity of the requested medication. Pruritus occurs in the majority of patients with polycythemia vera and is often exacerbated by bathing, especially with hot water, which results in aquagenic pruritus. Symptom management begins with simple measures such as avoidance of precipitating exposures such as paying attention to the temperature of the environment and the water used for bathing, adding laundry starch to bath water, drying the skin by patting rather than rubbing, and using moisturizing creams and antihistamines. Low-dose aspirin is generally effective for alleviating pruritus and other symptoms associated with polycythemia vera. Among cytoreductive agents, the most effective agent for pruritus associated with polycythemia vera is ruxolitinib, which this patient is already on. He and colleagues report that aprepitant has demonstrated effectiveness in several case series and open label trials in relieving pruritus for patients who are refractory to other treatments. Current medical literature supports the benefits of aprepitant in the setting of pruritus related to hematologic malignancies including T-cell lymphomas, polycythemia vera, and other malignancies. In this clinical setting, given that the patient has tried and failed several measures and medications for the treatment of debilitating aquagenic pruritus, and reports benefits from aprepitant 80 mg, the requested medication is medically indicated. Therefore, aprepitant 80 mg is medically necessary for the treatment of this patient.
1
The patient is a 23-year-old female with major depressive disorder, generalized anxiety disorder, and cannabis use disorder. The patient has requested reimbursement for adult mental health residential treatment center services from 11/06/21 through 11/30/21. The patient was admitted for residential treatment with passive suicidal ideation, frequent self-injurious behavior and poor coping skills and history of self-aborted suicide attempt. . The patient was unable to attend school or work due to severe symptoms. The patient was withdrawn socially from almost all social interactions.
Overturned
Medical Necessity
Summary Reviewer The patient is a 23-year-old female with major depressive disorder, generalized anxiety disorder, and cannabis use disorder. The patient has requested reimbursement for adult mental health residential treatment center services from 11/06/21 through 11/30/21. The physician reviewer found that The American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) provides a reliable framework for determining the appropriate level of care for adults needing mental health treatment. Using LOCUS, 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) medical, addictive and psychiatric comorbidity; (4) recovery environment (a. stressors and b. supports); (5) treatment and recovery history; and (6) engagement. The composite score is then used to determine the level of care needed. Applying the LOCUS framework, the patient met the criteria for residential treatment services provided 11/06/21 through 11/30/21. For dimension 1, risk of harm, the records support a score of 3. This dimension assesses potential for harm to self or others. The patient was admitted for residential treatment with passive suicidal ideation, frequent self-injurious behavior and poor coping skills and history of self-aborted suicide attempt. For dimension 2, functional status, the records support a score of 4. This dimension assesses the degree to which a person is able to fulfill social responsibilities, interacts with, maintain physical functioning and capacity for self-care. The patient was unable to attend school or work due to severe symptoms. The patient was withdrawn socially from almost all social interactions. For dimension 3, comorbidity, the records support a score of 3. This dimension assesses potential complications in the course of treatment due to acuity or disability related to co-occurring medical illness, substance use disorder, or psychiatric disorder. The patient has used cannabis daily prior to admission to the residential treatment center with significant negative impact on her psychiatric symptoms. For dimension 4A, level of stress of the recovery environment, the records support a score of 3. This dimension assesses the stressors in the environment, social circumstances, and interpersonal relationships. The patient had easy access to cannabis at home and had a recent break-up with her boyfriend of three years, causing increased stress. For dimension 4B, level of support of the recovery environment, the records support a score of 4. This dimension assesses the presence of family and social support to augment the recovery environment. The patient was isolated from friends, recently broke up with her boyfriend and isolated herself to her room much of the day, relying fully on her parents for support, although she had difficulty reaching out to even her parents. For dimension 5, treatment and recovery history, the records support a score of 4. This dimension assesses how past experiences with treatment and recovery might indicate how the patient might respond in the future. The patient was in outpatient treatment with inconsistent adherence to medications prior to residential treatment, but without optimal control of symptoms. For dimension 6, engagement, the records support a score of 3. This dimension assesses a patients understanding of her or her illness and treatment, and ability and willingness to engage in the treatment process. The patient appeared motivated in the residential treatment center, but had trouble engaging with some therapists and coped with stress in treatment with self-injury. These findings give the patient a composite score of 24, which is consistent with medically monitored residence-based services or residential treatment. Additionally, the patient scored a 4 in functional status, which supports residential treatment level of care. For these reasons, adult mental health residential treatment center services from 11/06/21 through 11/30/21 were medically necessary for the treatment of this patient.
1
A 55-year-old female enrollee has requested reimbursement for CPT code 95165, professional services for the supervision and provision of antigens for allergen immunotherapy provided from 2/10/15 through 2/13/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 1 A 55-year-old female enrollee has requested reimbursement for CPT code 95165, professional services for the supervision and provision of antigens for allergen immunotherapy provided from 2/10/15 through 2/13/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found the submitted letters from the patient and provider were reviewed. However, there is a lack of additional pertinent medical documentations, such as progress notes from the ordering provider. The progress notes submitted are from a different provider which documented the diagnosis of mast cell disorder, chemical sensitivities and food allergy. The only records from the ordering provider were testing records, which are insufficient to support the services at issue. The submitted records do not support a covered indication for the services at issue. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
0
The parent of a 17-year-old male enrollee has requested authorization and coverage for Dupixent (dupilumab) 300/2 ml injections. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The medical records document longstanding atopic dermatitis which has been recalcitrant to treatment with topical steroids, topical calcineurin inhibitors, prednisone and cyclosporine. patients condition has been poorly controlled with topical and systemic immunosuppressants. He has had side effects from cyclosporine, necessitating discontinuation.
Overturned
Medical Necessity
Summary Reviewer The parent of a 17-year-old male enrollee has requested authorization and coverage for Dupixent (dupilumab) 300/2 ml injections. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested medication in this clinical setting. The medical records document longstanding atopic dermatitis which has been recalcitrant to treatment with topical steroids, topical calcineurin inhibitors, prednisone and cyclosporine. Dupixent has been approved by the U.S. Food and Drug Administration for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older. This patients condition has been poorly controlled with topical and systemic immunosuppressants. He has had side effects from cyclosporine, necessitating discontinuation. Therefore, Dupixent (dupilumab) injections 300/2 ml are medically necessary for the treatment of this patient.
1
A 61-year-old male enrollee has requested reimbursement for surgical services (atrial fibrillation ablation) performed on 7/10/13. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees recurrent symptomatic atrial fibrillation. , the patient presented with symptomatic chronic atrial fibrillation that failed aggressive attempts to manage his condition medically.
Overturned
Experimental
Summary Reviewer 3 A 61-year-old male enrollee has requested reimbursement for surgical services (atrial fibrillation ablation) performed on 7/10/13. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees recurrent symptomatic atrial fibrillation. The physician reviewer found according to the documentation submitted for review, the patient presented with symptomatic chronic atrial fibrillation that failed aggressive attempts to manage his condition medically. The guidelines listed above support the use of catheter-based ablation (radio frequency or cryoablation) for management of patients in this clinical setting. For the reasons provided above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 24-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 7/06/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 2 A 24-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 7/06/21. 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 melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on the DecisionDx-Melanoma 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 7/06/21 was not likely to have been more beneficial than any available standard therapy.
0
A 65-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 6/13/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who has a history of breast cancer.
Overturned
Experimental
Summary Reviewer 1 A 65-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 6/13/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who has a history of breast cancer. The physician reviewer found that breast tomosynthesis was approved for clinical use by the U.S. Food and Drug Administration in 2011. Breast tomosynthesis provides advantages to radiologists interpreting mammograms. The use of this technique often allows the reader to separate dense glandular elements from underlying architectural distortion and mass, which in turn improves diagnostic accuracy, reduces callbacks and reduces negative biopsies. The medical evidence supports the service at issue in this clinical setting. Therefore, breast tomosynthesis performed on 6/13/17 was likely to have been of greater benefit 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 54-year-old female enrollee has requested reimbursement for residential substance use disorder treatment from 7/5/16 through 7/15/16. 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. This patient presented with addictive disorders complicated by an anxiety disorder. This patient presented with a history of alcoholism that began in mid-adolescence. Her drinking dominated multiple functional domains, impaired her sociability, marriage and relationships, and necessitated emergency services. She minimized her consumption and subsequent mood and anxiety issues. She was unemployed. She lived alone and had limited social support. She was unable to sustain sobriety despite an intensive chemical dependency program. She reportedly drank while in treatment. Three weeks
Overturned
Medical Necessity
Summary Reviewer A 54-year-old female enrollee has requested reimbursement for residential substance use disorder treatment from 7/5/16 through 7/15/16. 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 the services at issue in this clinical setting. This patient presented with addictive disorders complicated by an anxiety disorder. The placement determination largely falls upon providers working directly with the patient population. Assisting with this process, the American Psychiatric Association (APA) offers the following guidance on residential placement: Residential treatment is indicated primarily for individuals who do not meet clinical criteria for hospitalization but whose lives and social interactions have come to focus exclusively on substance use and who currently lack sufficient motivation and/or substance-free social supports to remain abstinent in an ambulatory setting. Both the APA Textbook and the American Society of Addiction Medicine echo this sentiment and recommend placement based on a complex, individual assessment. Additionally, the practice guideline jointly authored by the Department of Veterans Affairs and Department of Defense supports more intensive settings for certain cases: There is now a fair amount of research that indicates patients with greater substance use severity and co-occurring problems such as psychiatric disorders and housing problems will do better in more intensive forms of treatment. This patient presented with a history of alcoholism that began in mid-adolescence. Her drinking dominated multiple functional domains, impaired her sociability, marriage and relationships, and necessitated emergency services. She minimized her consumption and subsequent mood and anxiety issues. She was unemployed. She lived alone and had limited social support. She was unable to sustain sobriety despite an intensive chemical dependency program. She reportedly drank while in treatment. Three weeks of residential treatment was an insufficient duration of treatment to address the patients relationship with alcohol and mobilize the meaningful therapeutic momentum needed to foster sustained sobriety. The comprehensive services were delivered in accordance with an individual treatment plan. Further, the services were reasonably expected to improve the patients condition and prevent a more serious episode of illness. The placement facilitated active treatment, including group therapy, cognitive behavioral therapy, relaxation skills training and family counseling, and set the stage for meaningful aftercare. Finally, the duration of services was consistent with community practice standards. Considering the clinical presentation and the peer-reviewed literature, residential placement was a safe, appropriate disposition consistent with good medical practice. Accordingly, the services at issue were medically necessary for treatment of the patients behavioral health condition. Therefore, for the reasons stated above, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
A 28-year-old male enrollee has requested reimbursement for Foundation One gene test performed on 4/7/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with malignant peripheral nerve sheath tumor (MPNST).
Overturned
Experimental
Summary Reviewer 1 A 28-year-old male enrollee has requested reimbursement for Foundation One gene test performed on 4/7/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with malignant peripheral nerve sheath tumor (MPNST). The physician reviewer found that the malignant peripheral nerve sheath tumors (MPNST) are an uncommon but devastating tumor of peripheral nerve. About 22 to 50 percent of MPNSTs occur in patients with neurofibromatosis type 1 (NF1). Having a NF1 mutation adds information for prognosis and aids in follow-up decision making. FoundationOne offers the advantage of testing for NF1 mutations as well as others that may help guide therapeutic decision making should the patient progress. FoundationOne testing is likely to be more beneficial than not testing and not knowing the prognosis of the patient. In sum, FoundationOne testing performed on 4/7/15 was likely to have been more effective over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
The patient is a 51-year-old male with gastroesophageal reflux disease (GERD). Per the providers note dated 4/9/15, the patients symptoms include reflux, heartburn, emesis, and dysphagia. Esophageal manometry showed no classic abnormalities of esophageal motility or bolus transit on 3/9/15. A pH study with impedance showed elevated acid exposure, particularly when recumbent, and significant upright reflux with strong symptom correlation on 3/9/15. Per the provider, proton premalignant condition to esophageal adenocarcinoma. The patient has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational.
Upheld
Experimental
Summary Reviewer 1 The patient is a 51-year-old male with gastroesophageal reflux disease (GERD). Per the providers note dated 4/9/15, the patients symptoms include reflux, heartburn, emesis, and dysphagia. Esophageal manometry showed no classic abnormalities of esophageal motility or bolus transit on 3/9/15. A pH study with impedance showed elevated acid exposure, particularly when recumbent, and significant upright reflux with strong symptom correlation on 3/9/15. Per the provider, proton pump inhibitors have not been effective, and consistent and prolonged exposure to chronic acid due to uncontrolled GERD presents the possibility of progression to Barretts esophagus, which is considered a premalignant condition to esophageal adenocarcinoma. The patient has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational. Overall, there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than standard surgical anti-reflux procedures. One evidence review concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined (Sheu and Rattner). Another best-evidence review concluded that long-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval (Bauer, et al). Additionally, LINX more than surgical fundoplication is associated with severe dysphagia requiring endoscopic intervention (Sheu, et al). The currently available peer-reviewed literature does not support the conclusion that LINX is more likely to be beneficial in this case than standard treatment including surgical fundoplication (Sheu, et al; Ganz). Further, the American College of Gastroenterology (ACG) guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). For these reasons, the requested LINX device 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 14-year-old female who was admitted to a residential treatment center (RTC) on 3/25/22 and presented for an admissions assessment. The patients parent has requested reimbursement and prospective authorization and coverage for residential treatment services from 4/16/22 and onward. The patient has a significant risk of harm, due to a history of suicidal ideation. The patient and her family
Upheld
Medical Necessity
Summary Reviewer The patient is a 14-year-old female who was admitted to a residential treatment center (RTC) on 3/25/22 and presented for an admissions assessment. The patients parent has requested reimbursement and prospective authorization and coverage for residential treatment services from 4/16/22 and onward. The physician reviewer found that at issue is whether residential treatment services from 4/16/22 and onward were and are medically necessary for the treatment of this patient. The American Academy of Child and Adolescent Psychiatry (AACAP) and American Association for Community Psychiatry (AACP) have unified the Child and Adolescent Level of Care Utilization System (CALOCUS) and the Child and Adolescent Service Intensity Instrument (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. With regard to risk of harm, the records support a score of 3. The patient has a significant risk of harm, due to a history of suicidal ideation. The patient and her family are able to carry out a safety plan. In terms of functional status, the records support a score of 3. The documentation noted moderate functional impairment due to chronic and variably severe deficits in interpersonal relationships, but the patient is noted as having the ability to engage in socially constructive activities and maintain responsibilities. With regard to comorbidity, the records support a score of 2. The patient has minor comorbidity, due to the presence of occasional, self-limited episodes of substance use that show no pattern of escalation, without indication of adverse effects on functioning or the patients presenting condition. Specifically, the patient has experimented with using alcohol and cannabis but this use has been sporadic and shows no pattern escalation. In terms of level of stress of the recovery environment, the records support a score of3. The patient has a moderately stressful environment due to an interpersonal or material loss that has significant impact on patient and her family, specifically, the chronic loss of her fathers involvement in her life. With regard to level of support of the recovery environment, the records support a score of 2 due to the patients primary caretaker, her mother, being willing and able to participate in treatment if requested to do so and with the have capacity to effect needed changes. The patients special needs, including for home/remote schooling, are addressed through successful involvement in systems of care. In terms of resiliency and treatment history, the records support a score of 3. The patient has moderate or equivocal response to treatment due to an inconsistent or equivocal capacity to deal with stressors and maintain normal development. With regard to treatment acceptance and engagement, the records support a score of 3. The patient acknowledges the existence of a problem, but resists accepting even limited age-appropriate responsibility for the development, perpetuation, or consequences of the problem. Thus, the patient has a total score of 19. In this case, the recommended level of care is high intensity community-based services. This is inconsistent with the level of care that the patient was and is receiving at the residential treatment center (RTC). Therefore, residential treatment services from 4/16/22 and onward were not and are not medically necessary for the treatment of this patient.
1
A 49-year-old male enrollee has requested reimbursement for the chiropractic services (CPT codes 98941, 98943, 97110, and 97012) provided on 12/14/16, 4/21/17, 5/17/17, 6/9/17, and 7/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees neck and shoulder pain. that the patient has a chronic condition and has received extensive chiropractic care.
Upheld
Medical Necessity
Summary Reviewer A 49-year-old male enrollee has requested reimbursement for the chiropractic services (CPT codes 98941, 98943, 97110, and 97012) provided on 12/14/16, 4/21/17, 5/17/17, 6/9/17, and 7/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees neck and shoulder pain. The physician reviewer found that the patient has a chronic condition and has received extensive chiropractic care. However, there is no clear objective documentation on functional improvement or specific goals with chiropractic treatment. The records suggest that the treatments have been provided as supportive care. Chiropractic maintenance therapy is defined as a treatment plan that seeks to prevent disease, promote health, and prolong or enhance the quality of life, or therapy is that is performed to maintain or prevent deterioration of a chronic condition. As noted by the Centers for Medicare and Medicaid Services (CMS), when further clinical improvement cannot reasonably be expected from continuous ongoing care, the chiropractic treatment becomes supportive rather than corrective in nature, the treatment is considered maintenance therapy and not considered medically necessary. Therefore, the chiropractic treatments with ancillary treatments provided on 12/14/16, 4/21/17, 5/17/17, 6/9/17, and 7/6/17 were not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
1
A 50-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 8/03/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. that the tumor had apparently regressed spontaneously prior to biopsy.
Upheld
Experimental
Summary Reviewer 1 A 50-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 8/03/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add a bit to these statistics. This particular melanoma could not be accurately staged, as the thickness could not be determined due to the fact that the tumor had apparently regressed spontaneously prior to biopsy. The features that could be seen included that there was no ulceration and no mitoses. DecisionDx-Melanoma testing is a study of 31 genes in a particular melanoma. It then classifies that melanoma into either Class 1 or 2, with a significant difference in the risk of recurrence at five years between these two classes. Gerami reported on 217 cases, with good correlation in prognosis between the two DecisionDx-Melanoma testing classes in patients who have undergone sentinel node biopsy. Berger and colleagues reported on 156 patients, but the follow-up was not sufficient to determine the real value of the test. It is not clear how the five-year DecisionDx-Melanoma testing data compares to the ten-year Balch data. Most importantly, it has not been shown that DecisionDx-Melanoma testing can be used to make clinical decisions about treatment. Therefore, DecisionDx-Melanoma testing performed on 8/03/18 was not likely to have been more beneficial than other methods of evaluating this patient.
1
The patient is a 55-year-old female with a history of hyperlipidemia. Per the medical records, she is intolerant to multiple statin medications. The submitted documentation noted coronary artery disease including prior coronary artery revascularization. On 12/14/17, low-density lipoprotein (LDL) level was 182 mg/dL. The patient has requested coverage for Praluent injection 75 mg/ml subcutaneous solution. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. medication. This patient has known obstructive coronary disease and marked hyperlipidemia. She is intolerant of several statin medications. Praluent
Overturned
Medical Necessity
Summary Reviewer The patient is a 55-year-old female with a history of hyperlipidemia. Per the medical records, she is intolerant to multiple statin medications. The submitted documentation noted coronary artery disease including prior coronary artery revascularization. On 12/14/17, low-density lipoprotein (LDL) level was 182 mg/dL. The patient has requested coverage for Praluent injection 75 mg/ml subcutaneous solution. 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 submitted documentation supports the medical necessity of the requested medication. This patient has known obstructive coronary disease and marked hyperlipidemia. She is intolerant of several statin medications. Praluent is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor studied in and approved for patients with heterozygous familial hypercholesterolemia or for patients with documented atherosclerotic heart disease who require additional lowering of LDL cholesterol. This patient fits the latter category. There is documented intolerance to several statin medications, and the use of ezetimibe alone would not be expected to achieve an LDL reduction to less than 70 mg/dL, the current goal in patients with documented obstructive coronary disease, such as this patient. PCSK9 inhibitors such as Praluent have been documented in several randomized controlled trials to be safe and effective at lowering LDL cholesterol and associated with improved outcomes. Thus, Praluent injection 75 mg/ml subcutaneous solution is medically necessary for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
A 24-year-old female enrollee has requested authorization and coverage for lower esophageal myotomy, transoral (peroral endoscopic myotomy) (POEM) and one inpatient day. The Health Plan has denied this request indicating that the requested service is investigational for the treatment of the enrollees medical condition. this patient has a longstanding history of achalasia and has had symptoms of dysphagia, regurgitation and weight loss. She has undergone various tests including, esophageal manometry, and pH testing, which are collectively of a diagnosis of achalasia. Her symptoms have been refractory to therapy with esophageal dilatation. The provider has recommended the POEM procedure.
Overturned
Experimental
Summary Reviewer 3 A 24-year-old female enrollee has requested authorization and coverage for lower esophageal myotomy, transoral (peroral endoscopic myotomy) (POEM) and one inpatient day. The Health Plan has denied this request indicating that the requested service is investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has a longstanding history of achalasia and has had symptoms of dysphagia, regurgitation and weight loss. She has undergone various tests including, esophageal manometry, and pH testing, which are collectively suggestive of a diagnosis of achalasia. Her symptoms have been refractory to therapy with esophageal dilatation. The provider has recommended the POEM procedure. In reviewing the literature, there is a lack of well-designed randomized controlled trials that have proven the safety and efficacy of the requested therapy. Therefore, lower esophageal myotomy, transoral POEM and one inpatient day is not likely to be more beneficial than any available standard therapy.
1
A 58-year-old female enrollee has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD) and esophagitis. This patient has undergone much of this pre-operative assessment. Although this patient has GERD as based on pH recording and Barretts histology,
Upheld
Experimental
Summary Reviewer 2 A 58-year-old female enrollee has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD) and esophagitis. The physician reviewer found that the LINX device received U.S. Food and Drug Administration (FDA) premarketing approval in March 2012. The approved indication was for patients with diagnosed GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximal medical therapy for the treatment of reflux. Currently, upper endoscopy, barium esophagram, pH testing, and manometry are required for preoperative work-up for antireflux surgery (Jobe, et al). This patient has undergone much of this pre-operative assessment. Although this patient has GERD as based on pH recording and Barretts histology, the available records do not demonstrate that she is medically refractory to acid blocker drugs. Also, implantation of LINX in this patients setting must be approached with caution given her documented esophageal dysmotility and functional outlet obstruction and because LINX has not been adequately evaluated in patients with Barretts esophagus. As such, the requested LINX device is not likely to be more beneficial than available standard therapy for treatment of this patients medical condition. 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