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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. | Upheld | Experimental | Summary Reviewer 3
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 Epstein-Barr virus is the main etiology of infectious mononucleosis (IM) syndrome that is characterized by fever, sore throat, and lymph adenopathy. Since this virus could be associated with a number of malignancies, some hematologic disorders, and chronic fatigue syndrome, identification of IM is of importance. The majority of the human adult population is infected with EBV. Usually the infection is well tolerated without any further symptoms after primary infection. In some patients with infectious mononucleosis, or in some who had an infection in their past, it may be important to diagnose symptomatic disease or differentiate infectious mononucleosis from other conditions. In these cases, serological methods, i.e., immunofluorescence, ELISA, or Western blot, are the methods of choice to come to an unequivocal diagnostic conclusion, while the detection and quantification of viral DNA through PCR plays a minor role. ELISA could be applied as a first and preliminary diagnostic test for IM. In addition, this test could be applied in various phases of the disease with a higher sensitivity comparing to PCR. In individuals where EBV infection is associated or causally linked with autoimmune or malignant disease or in patients who have been bone marrow or solid organ transplanted, or in patients with severe immune-suppression, prolonged EBV primary infection or EBV reactivation from latency may be a serious and life-threatening complication. As such, determining the serostatus correctly is important for these patients. However, in this patients case, there was no documentation that this patient had immunosuppression or that she was a transplant patient. In sum, for this patient who presented with lymphadenopathy of unknown origin, PCR testing provided on 5/30/17, was not likely to have been superior over other standard methods of evaluating her medical condition. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 40-year-old female enrollee has requested reimbursement for fetal sex chromosome analysis, circulating cell-free fetal DMA in the maternal blood provided on 6/13/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 40-year-old female enrollee has requested reimbursement for fetal sex chromosome analysis, circulating cell-free fetal DMA in the maternal blood provided on 6/13/19. 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 screening for the most common sex chromosome aneuploidies is controversial because these individuals have fewer serious physical abnormalities than those with trisomy 21, 18, or 13, and the phenotypic features are much more variable. The American College of Medical Genetics and Genomics (ACMGG) does not recommend use of cell-free DNA to screen for autosomal aneuploidies other than those involving chromosomes 13, 18, and 21. The Harmony Noninvasive Prenatal Testing offers screening for traditional aneuploidies (13, 18 and 21), which is evidence-based and standard of care. However, the test also offers screening for common sex chromosome aneuploidies, which is not recommended by the ACMGG and does not reflect standard of care. Therefore, fetal sex chromosome analysis (CPT 81599) performed on 6/13/19 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 36-year-old female enrollee has requested reimbursement for gene testing (MaterniT21 Plus) performed on 2/03/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pregnancy. | Upheld | Experimental | Summary Reviewer 1
A 36-year-old female enrollee has requested reimbursement for gene testing (MaterniT21 Plus) performed on 2/03/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pregnancy. The physician reviewer found the current standard of care recommends offering prenatal cell free fetal DNA testing to patients at increased risk. This population is defined as women 35 years or older, fetuses with ultrasonographic findings indicative of an increased risk of aneuploidy, women with a history of trisomy-affected offspring, a parent carrying a balanced Robertsonian translocation with an increased risk of trisomy 13 or trisomy 21, and women with positive first-trimester or second-trimester screening test results. Earlier testing increases the chance of a false-negative test due to inadequate amounts of genetic material at earlier gestational ages. However, cell free testing has not been approved for use in multiple gestations due to limitations on accuracy. Additionally, this patient underwent cell free fetal DNA testing when she was only seven weeks gestation, which is earlier than recommended. All told, the superior efficacy of gene testing performed on 2/03/15 has not been established. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 42-year-old female enrollee has requested reimbursement for mental health inpatient services provided from 5/11/15 through 5/14/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees bipolar disorder type 1.
The records indicate that this patient was plagued with the most serious of affective disorders.
During the course of the admission, the patient was hostile, unpredictable and agitated. She had difficulty self-regulating her behaviors and poor insight to her illness. She had refused mood stabilizing medication. On 5/6/15, she was administered psychotropic medication via injection due to her agitation. On 5/11/15, the patient was assessed to lack medical decision making capacity. Thereafter, she was adherent with pharmacotherapy. On 5/12/15, the patients hostility had tempered to irritability while she remained circumstantial, paranoid and grandiose. However, the patient evidenced a positive response to pharmacologic intervention. She was guarded, but better organized and able to participate in discharge planning. Although not suicidal, the patients condition was consistent with grave disability. | Overturned | Medical Necessity | Summary Reviewer
A 42-year-old female enrollee has requested reimbursement for mental health inpatient services provided from 5/11/15 through 5/14/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees bipolar disorder type 1. The physician reviewer found that modern psychiatric practice aims to place patients in the least restrictive treatment setting. Although community intervention settings optimize treatment gains, episodic placement in more restrictive settings is often clinically appropriate for those with serious mental illness. The records indicate that this patient was plagued with the most serious of affective disorders. Bipolar disorder with psychotic features is commonly associated with poor clinical outcomes. When considering the formidable symptom complex, multiple recent hospitalizations, available support system and functional impairment across multiple domains, a conservative inpatient hospitalization was to be expected. During the course of the admission, the patient was hostile, unpredictable and agitated. She had difficulty self-regulating her behaviors and poor insight to her illness. She had refused mood stabilizing medication. On 5/6/15, she was administered psychotropic medication via injection due to her agitation. On 5/11/15, the patient was assessed to lack medical decision making capacity. Thereafter, she was adherent with pharmacotherapy. On 5/12/15, the patients hostility had tempered to irritability while she remained circumstantial, paranoid and grandiose. However, the patient evidenced a positive response to pharmacologic intervention. She was guarded, but better organized and able to participate in discharge planning. Although not suicidal, the patients condition was consistent with grave disability. Based on her illness burden and history of multiple psychiatric admissions in less than one year, the mental health inpatient services provided from 5/11/15 through 5/14/15 were reasonably expected to improve her condition and prevent a more serious episode of illness and thus were medically necessary. Based on the foregoing discussion, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 36-year-old male enrollee has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request indicating that the device at issue was considered investigational for evaluation of the enrollee, who reported palpitations. The physician reviewer found that the patient is a 36-year-old male with a history of hypertension and diabetes. He reported palpitations. Per the records, the patient underwent a 30-day external event monitor which revealed a symptomatic, but single episode, of atrial fibrillation lasting approximately 30 seconds. He was referred for implantable loop recorder to further assess atrial arrhythmic burden. The patient has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request and reported that the device at issue was investigational for the evaluation of this patient. The patient has symptoms of palpitations and would be at
he had a significant burden atrial fibrillation associated with these episodes. He would
lifelong anticoagulation. He was first assessed appropriately with an external 30-day event monitor which revealed one episode of symptomatic, although short-lived, atrial fibrillation. | Upheld | Experimental | Summary Reviewer 1
A 36-year-old male enrollee has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request indicating that the device at issue was considered investigational for evaluation of the enrollee, who reported palpitations. The physician reviewer found that the patient is a 36-year-old male with a history of hypertension and diabetes. He reported palpitations. Per the records, the patient underwent a 30-day external event monitor which revealed a symptomatic, but single episode, of atrial fibrillation lasting approximately 30 seconds. He was referred for implantable loop recorder to further assess atrial arrhythmic burden. The patient has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request and reported that the device at issue was investigational for the evaluation of this patient. The patient has symptoms of palpitations and would be at higher risk for embolic stroke if he had a significant burden atrial fibrillation associated with these episodes. He would then likely require lifelong anticoagulation. He was first assessed appropriately with an external 30-day event monitor which revealed one episode of symptomatic, although short-lived, atrial fibrillation. A single 30-second episode of atrial fibrillation may not be a definite indication to commit this patient to lifelong anticoagulation, but more sustained or frequent episodes may be an indication for lifelong anticoagulation. In this setting, an implantable recording device is a reasonable next step to assess the full burden of atrial fibrillation prior to starting anticoagulation. Therefore, implantable ambulatory event monitor provided on 12/28/17 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the device at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 12/16/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
, it appears the patient was tested for trichomonas (not by polymerase chain reaction testing, but via RNA testing), and was not tested for chlamydia or gonorrhea. | Upheld | Experimental | Summary Reviewer 1
A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 12/16/18. 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 Polymerase chain reaction testing is appropriate and medically indicated when done to test for chlamydia, gonorrhea, and trichomonas. In this case, it appears the patient was tested for trichomonas (not by polymerase chain reaction testing, but via RNA testing), and was not tested for chlamydia or gonorrhea. Instead, multiple polymerase chain reaction tests were done for various other vaginal organisms, some of which do not even cause infection, including candida species, lactobacillus species, Atopobium vaginae, Megasphaera species, and Gardnerella vaginalis quantification. Polymerase chain reaction testing for these organisms is not standard of care. The standard testing for evaluation of a vaginal discharge includes assessing the symptoms, the appearance of the discharge, pH testing of the vaginal fluid, examination of the discharge under the microscope, and sometimes DNA probes or cultures. Therefore, polymerase chain reaction testing performed on 12/16/18 was not likely to have been superior over other methods of evaluating this patient.
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A 57-year-old female enrollee has requested reimbursement for the hysterectomy performed on 1/16/17. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees post-menopausal bleeding.
this patient presented with a history of post-menopausal bleeding that interfered with her activities of daily living and did not responded to medical management.
This patient was treated with conservative management, which was hormonal therapy appropriate for her age. | Overturned | Medical Necessity | Summary Reviewer
A 57-year-old female enrollee has requested reimbursement for the hysterectomy performed on 1/16/17. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees post-menopausal bleeding. The physician reviewer found that the records provided for review document that this patient presented with a history of post-menopausal bleeding that interfered with her activities of daily living and did not responded to medical management. Per the American College of Obstetricians and Gynecologists (ACOG), late peri-menopausal patients may be treated with cyclic progestin therapy, low-dose oral contraceptive pills, the levonorgestrel intrauterine device (IUD), or cyclic hormone therapy. The ACOG further noted that women who have completed childbearing, in whom medical therapy has failed, or who have contraindications to medical therapy are candidates for hysterectomy without cervical preservation. Appropriate treatment includes an endometrial ablation or hysterectomy. Endometrial ablation is not definitive therapy and is generally considered for premenopausal women. This patient was treated with conservative management, which was hormonal therapy appropriate for her age. Given the ACOG recommendations for patients who have failed conservative therapy in this clinical setting, the hysterectomy performed on 1/16/17 was medically necessary for treatment of this patients post-menopausal bleeding. Based on the foregoing discussion, the surgery at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 56-year-old male enrollee has requested reimbursement for a polysomnography performed on 4/27/15. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary for evaluation of the enrollees snoring.
, the patient presented with multiple symptoms strongly suggestive of obstructive sleep apnea, both on the basis of his reported symptoms and his medical history. | Upheld | Medical Necessity | Summary Reviewer
A 56-year-old male enrollee has requested reimbursement for a polysomnography performed on 4/27/15. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary for evaluation of the enrollees snoring. The physician reviewer found that in this case, the patient presented with multiple symptoms strongly suggestive of obstructive sleep apnea, both on the basis of his reported symptoms and his medical history. While polysomnography has traditionally been used to evaluate patients with obstructive sleep apnea, there has been a paradigm shift towards testing for obstructive sleep apnea in the home environment. As a result, it has become more common to test patients with suspected obstructive sleep apnea with unattended sleep testing. Such testing has been shown to be equally beneficial in terms of the establishment of obstructive sleep apnea as lab testing in a less intense environment. In this case, there is a lack of documentation of any contraindications to unattended testing. Given that there has been a change in this diagnostic paradigm towards ambulatory testing, the services that were performed exceeded the patients clinical needs. Thus, the polysomnography performed on 4/27/15 was not medically necessary for evaluation of this patients medical condition. Based on the foregoing discussion, the diagnostic procedure at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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A 37-year-old female enrollee has requested reimbursement for Butrans received on 10/3/15. The Health Insurer has denied this request indicating that the medication at issue was medically necessary for treatment of the enrollees medical condition. The physician reviewer found the patient presented with a history of chronic pain. | Upheld | Medical Necessity | Summary Reviewer
A 37-year-old female enrollee has requested reimbursement for Butrans received on 10/3/15. The Health Insurer has denied this request indicating that the medication at issue was medically necessary for treatment of the enrollees medical condition. The physician reviewer found the patient presented with a history of chronic pain. The step wise WHO ladder for pain relief is considered the reasonable approach to pain control in the palliative setting. (Raffa et al). In this patients case it does not appear all non-opioid treatment options had been utilized. Further, there was no plan in place to monitor this patients medications either historically and currently (Jamison et al). Moreover, it is unclear as to whether the diagnosis of chronic regional pain syndrome (CRPS) was supported. Based upon the information provided, the patient only appears to have met one of the criteria for such diagnosis and as noted in the medical records the patient has chronic pain syndrome and possibly fibromyalgia (Wurtman). Finally, multiple minimal requirements for opioid prescribing were not documented and the need to use Butrans to taper the patients opioid use is not supported. Pain specialists generally use taper medications that are not long-acting. Rather than using Butrans, buprenorphine oral form or methadone would be used for tapering purposes to get off another opioid. Moreover, there is no need to actually change opioids to taper; the physician can simply start decreasing the already prescribed opioids. As such, the medical necessity of the Butrans obtained on 10/3/15 has not been established. For the reasons set forth above, the medication at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 3
A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines indicate 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. The results of the services at issue were not likely to have altered treatment and surveillance recommendations. Thus, DecisionDx-Melanoma assay provided on 3/21/18 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.
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The patient is a 41-year-old male with a history of chronic left knee pain and swelling on both the medial and lateral aspects. The patient has requested reimbursement for synovectomy performed on 6/19/20 (CPT 29876). The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
, 61 patients with chronic mono-articular synovitis of the knee were followed for two years and underwent x-rays, MRI scans, and arthroscopic synovectomy with histopathological examination. The histopathological examination showed chronic nonspecific inflammation in 28 patients (46%).
ovium. The patient presented with chronic pain and swelling of one knee for a year. There was a loose body on the MRI that turned out to be hypertrophied synovium with calcification. The joint effusion and restricted range of motion (0-90) was associated with chronic syno | Overturned | Medical Necessity | Summary Reviewer
The patient is a 41-year-old male with a history of chronic left knee pain and swelling on both the medial and lateral aspects. The patient has requested reimbursement for synovectomy performed on 6/19/20 (CPT 29876). The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found the article by Goyal and colleagues pertains to chronic synovitis involving a single large joint. In this study, 61 patients with chronic mono-articular synovitis of the knee were followed for two years and underwent x-rays, MRI scans, and arthroscopic synovectomy with histopathological examination. The histopathological examination showed chronic nonspecific inflammation in 28 patients (46%). Felson and colleagues discussed the relationship of untreated chronic synovitis to osteoarthritis, indicating the medical necessity of such treatment. In this patients case, the synovectomy was medically necessary for establishing a diagnosis as well as symptomatic relief by resecting hypertrophic synovium. The patient presented with chronic pain and swelling of one knee for a year. There was a loose body on the MRI that turned out to be hypertrophied synovium with calcification. The joint effusion and restricted range of motion (0-90) was associated with chronic synovitis that warranted arthroscopic synovectomy for a definitive diagnosis as well as treatment. The diagnosis was chronic non-specific synovitis, which was treated appropriately. Therefore, synovectomy performed on 6/19/20 (CPT 29876) was medically necessary for the treatment of this patient.
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A 54-year-old female has requested reimbursement for chemotherapy treatment provided from 10/06/17 through 12/13/17. The Health Insurer has denied this request indicating that the medication regimen at issue was considered investigational for treatment of the enrollees gallbladder cancer. | Upheld | Experimental | Summary Reviewer 2
A 54-year-old female has requested reimbursement for chemotherapy treatment provided from 10/06/17 through 12/13/17. The Health Insurer has denied this request indicating that the medication regimen at issue was considered investigational for treatment of the enrollees gallbladder cancer. The physician reviewer found that although there is no standard second-line therapy for patients, most experts would recommend a fluorouracil based regimen after progression on gemcitabine and oxaliplatin. There are phase II trials that support the following combinations: gemcitabine/oxaliplatin, gemcitabine/capecitabine, capecitabine/cisplatin, capecitabine/oxaliplatin, 5-fluorouracil/oxaliplatin, 5-fluorouracil/cisplatin, and the single agents gemcitabine, capecitabine, and 5-fluorouracil in the unresectable or metastatic setting. There is a lack of literature to support the combination of FOLFIRI plus bevacizumab (Avastin) for second-line metastatic gallbladder cancer. In sum, chemotherapy treatment provided from 10/06/17 through 12/13/17 was not likely to have been more effective than other methods of treating this patient. Based upon the information set forth above, the medication regimen at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 53-year-old male enrollee has requested reimbursement for the bronchial thermoplasty provided from 1/21/15 through 4/8/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees persistent asthma.
smooth muscle of the airway. The tissue is heated to 65 degrees Centigrade. There are three bronchoscopic procedures. The first procedure treats the right lower lobe, the second focused on the left lower lobe, and the third procedure is for both upper lobes. The procedures are scheduled three weeks apart. | Overturned | Experimental | Summary Reviewer 3
A 53-year-old male enrollee has requested reimbursement for the bronchial thermoplasty provided from 1/21/15 through 4/8/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees persistent asthma. The physician reviewer found that bronchial thermoplasty is a procedure that uses a bronchoscope probe/catheter to provide thermal energy to the smooth muscle of the airway. The tissue is heated to 65 degrees Centigrade. There are three bronchoscopic procedures. The first procedure treats the right lower lobe, the second focused on the left lower lobe, and the third procedure is for both upper lobes. The procedures are scheduled three weeks apart. The provider states that bronchial thermoplasty has been U.S. Food and Drug Administration (FDA) approved for the treatment of patients with asthma. However, bronchial thermoplasty has not been FDA approved for use in this clinical setting. Further, there is a paucity of data from well designed, randomized, controlled clinical trials demonstrating the long-term safety and efficacy of the device for use as a generally accepted, standard of care for the treatment of asthma. The provider states the patient has a progressive decrease in the quality of life but there is no documentation that the use bronchial thermoplasty would improve the long-term functional outcome of the patients condition. For these reasons, the bronchial thermoplasty services provided from 1/21/15 through 4/8/15 were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 54-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Perjeta and Herceptin combination from 9/08/15 forward. The Health Insurer has denied this request indicating that the medications at issue were not and are not medically indicated for treatment of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 54-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Perjeta and Herceptin combination from 9/08/15 forward. The Health Insurer has denied this request indicating that the medications at issue were not and are not medically indicated for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested medication combination. Perjeta is a monoclonal antibody which targets the HER2 positive breast cancer cells, similar to, but not exactly in the same way, as Herceptin. In metastatic breast cancer, when used in combination with Herceptin and Taxotere, Perjeta yields superior progression-free survival compared to treatment with Taxotere and Herceptin without Perjeta. Combining Perjeta with Herceptin and chemotherapy also appears superior in the neoadjuvant setting. However, there is a lack of data supporting the use of combined Herceptin and Perjeta in the adjuvant setting. At this time, the current medical evidence has not established the medical necessity of the requested medication combination in this clinical setting. All told, Perjeta and Herceptin combination from 9/08/15 forward were not and are not medically indicated for the treatment of this patient. Therefore, the medications at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 71-year-old male enrollee has requested reimbursement ablation of the prostate, transrectal high intensity focused ultrasound (HIFU) including imaging guidance performed on 12/20/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee who has a history of prostate cancer. The physician reviewer found that the patient is a 71-year-old male who was found to have elevated prostate specific antigen (PSA) in 2011. The patient underwent transrectal ultrasound and guided biopsy of his prostate at that time. He was found to have moderate risk prostate cancer with clinical stage T2c. He was consulted regarding treatment options. The patient elected high intensity focused ultrasound ablation of his prostate (HIFU) in 2011. Initially he did well; however, he had progressive elevation of his PSA. It was assumed that the patient had a recurrence. He again underwent ablation of the prostate using transrectal HIFU including imaging guidance performed on 12/20/17. The patient has requested reimbursement for the services at issue. The Health Insurer has denied this request for reimbursement and noted that the ablation of the prostate using transrectal HIFU including imaging guidance performed on 12/20/17 was | Upheld | Experimental | Summary Reviewer 3
A 71-year-old male enrollee has requested reimbursement ablation of the prostate, transrectal high intensity focused ultrasound (HIFU) including imaging guidance performed on 12/20/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee who has a history of prostate cancer. The physician reviewer found that the patient is a 71-year-old male who was found to have elevated prostate specific antigen (PSA) in 2011. The patient underwent transrectal ultrasound and guided biopsy of his prostate at that time. He was found to have moderate risk prostate cancer with clinical stage T2c. He was consulted regarding treatment options. The patient elected high intensity focused ultrasound ablation of his prostate (HIFU) in 2011. Initially he did well; however, he had progressive elevation of his PSA. It was assumed that the patient had a recurrence. He again underwent ablation of the prostate using transrectal HIFU including imaging guidance performed on 12/20/17. The patient has requested reimbursement for the services at issue. The Health Insurer has denied this request for reimbursement and noted that the ablation of the prostate using transrectal HIFU including imaging guidance performed on 12/20/17 was investigational for the treatment of this patients medical condition.High-intensity focused ultrasound therapy for prostate cancer is a relatively new procedure. The U.S. Food and Drug administration has approved this procedure to be safe for treatment of prostate ablation. However, there is no specific indication for treatment for prostate cancer and there is no significant information regarding salvage therapy following HIFU. At this time, HIFU therapy for recurrent prostate cancer following initial treatment is not considered a standard of care in this clinical setting. Accordingly, transrectal HIFU including imaging guidance performed on 12/20/17 was not likely to have been more effective when compared to other treatment modalities for the treatment of this patients medical condition. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 17-year-old male enrollee has requested reimbursement for mental health residential treatment services provided from 4/9/14 through 10/19/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse and parent-child relational problem. | Upheld | Medical Necessity | Summary Reviewer
The parent of a 17-year-old male enrollee has requested reimbursement for mental health residential treatment services provided from 4/9/14 through 10/19/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse and parent-child relational problem. The physician reviewer found that the additional data confirms the history of antisocial behavior and running away. However, there is a lack of evidence that placement in this facility addressed the patients issues of poor motivation. The additional records did not document any further indication of risk to self or others, significant medical comorbidity, risk of withdrawal or other symptoms which required containment on a 24-hour basis. As noted in the previous review, the American Psychiatric Association (APA) practice guidelines indicate that patients should be managed in the least restrictive setting which is likely to be safe and effective. The additional records do not include any indication that the patient could not have been safely managed on an ambulatory basis during the time period in question and the records from the facility fail to indicate that the patient could not have been effectively managed on an outpatient basis. Further, the records provide no evidence of withdrawal symptoms and no clinical evidence that treatment at a lower level of care was not feasible, available or appropriate for the patients condition, as recommended in the Milliman Care Guidelines. Overall, the records do not support the medical necessity of mental health residential treatment services from 4/9/14 through 10/19/14 as treatment for this patients medical condition. Accordingly, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 53-year-old female enrollee has requested reimbursement for gene testing performed on 7/5/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees bilateral thyroid nodules.
This patients biopsy was suspicious for follicular lesion of undetermined significance. | Overturned | Experimental | Summary Reviewer 2
A 53-year-old female enrollee has requested reimbursement for gene testing performed on 7/5/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees bilateral thyroid nodules. The physician reviewer found that there is sufficient support for the Afirma gene test performed on 7/5/16 in this clinical setting. This patients biopsy was suspicious for follicular lesion of undetermined significance. The Afirma testing was suspicious, and a determining factor in delineating the further course of action to assess whether a surgical procedure was warranted. Afirma testing is considered standard protocol on fine needle aspirations performed on thyroid nodules. In sum, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 50-year-old male has requested reimbursement for Anser IFX testing performed on 4/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 50-year-old male has requested reimbursement for Anser IFX testing performed on 4/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence has not established the superior efficacy of the services at issue. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, there are few well-controlled clinical trials to confirm that use of the Anser IFX testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement. It has not been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. As such, Anser IFX testing performed on 4/15/16 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a one-year-old male enrollee has requested authorization and coverage for Olumiant
1 mg tablet. The Health Insurer has denied this request and reported that the requested medication
is investigational for the treatment of the enrolleeas medical condition.
calcification, chronic cerebrospinal fluid (CSF) lymphocytosis, | Overturned | Experimental | Summary Reviewer 2
The parent of a one-year-old male enrollee has requested authorization and coverage for Olumiant
1 mg tablet. The Health Insurer has denied this request and reported that the requested medication
is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that AGS is a rare monogenic interferonopathy characterized by variable neurologic dysfunction,
ranging from mild spastic paraparesis to quadriparesis and severe cognitive disability. Mutations
on one of six genes involved in nucleic acid repair have been implicated in the majority of cases,
with additional rare ade novoa autosomal dominant cases. Excessive interferon production results
in systemic inflammation and extensive end organ injury. Patients typically present with altered
mental status, including lethargy and irritability, feeding intolerance, and neurologic
abnormalities, such as loss of gross motor skills, seizures, or spasticity. Some patients may also
exhibit signs of systemic autoinflammation, such as fevers and skin involvement. There is evidence
of basal ganglia calcification, chronic cerebrospinal fluid (CSF) lymphocytosis, and elevated CSF
interferon type I. There are similarities and symptom overlap with systemic lupus erythematosus.
Overall, there is currently significant morbidity and high rate of mortality associated with this
syndrome. As a disorder of inappropriate immune activation, AGS has prompted interest in
immune-mediation therapies, including Janus kinase (JAK) inhibitors, reverse transcriptase
inhibitors, anti-IFN-alpha antibodies, anti-interleukin antibodies, antimalarial drugs, and other
cGAS inhibitors. Olumiant (baricitinib) is an oral JAK1/2 inhibitor that has been approved for
treatment of rheumatoid arthritis and has been used in case studies on patients with AGS.
Individual patients with AGS experienced decreased skin manifestations as well as improved
neurologic function following treatment with baricitinib.
This medication has not been approved by the U.S. Food and Drug Administration (FDA) in this
population, and the majority of articles cite the need for ongoing clinical studies, which are
particularly challenging given the heterogeneous nature of this disease. However, the FDA has
listed AGS as one of the conditions for which baricitinib can be used on a compassionate basis.
This medication is the only treatment available and is more likely to be beneficial than standard
therapy (symptomatic treatment only). Therefore, Olumiant 1 mg tablet is likely to be more
beneficial than other available standard therapy.
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A 69-year-old female enrollee has requested reimbursement for air ambulance services provided on 6/18/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
. On 6/15/18, a request for urgent pre-authorization for medically configured fixed-wing air transport was sent to the Health Insurer. On 6/18/18, the patient was transferred by medically configured fixed-wing aircraft to the receiving inpatient rehabilitation center. On 6/19/18, four days after the request for urgent pre-authorization, the Health Insurer authored a denial letter for the services in question. As detailed in the air ambulance records, the patient at the time of transport was described as alert but nonverbal, and she did not follow commands. The records noted left-sided weakness. She was not a candidate for commercial air travel. | Overturned | Medical Necessity | Summary Reviewer
A 69-year-old female enrollee has requested reimbursement for air ambulance services provided on 6/18/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that Shirley Ryan Ability Lab is a state of the art inpatient rehabilitation campus determined to be the best option for this patient. On 6/15/18, a request for urgent pre-authorization for medically configured fixed-wing air transport was sent to the Health Insurer. On 6/18/18, the patient was transferred by medically configured fixed-wing aircraft to the receiving inpatient rehabilitation center. On 6/19/18, four days after the request for urgent pre-authorization, the Health Insurer authored a denial letter for the services in question. As detailed in the air ambulance records, the patient at the time of transport was described as alert but nonverbal, and she did not follow commands. The records noted left-sided weakness. She was not a candidate for commercial air travel. The receiving facility was greater than 303 miles away with a reported five-hour ground transport time; well outside generally accepted time limits for this type of patient. In sum, the Shirley Ryan Ability Lab was determined to be the best option for this patient, and she was not a candidate for ground transport or commercial air travel. Therefore, air ambulance services provided on 6/18/18 were medically necessary for the treatment of this patient. | 1 |
The patient is a 45-year-old female with chronic low back pain, hip/buttock and tailbone pain and numbness and tingling above the knee. The onset of pain was atraumatic and began in November 2013. On 6/07/18, her pain was rated at 7 to 9/10 and was getting worse. She is status post L3-4 lumbar fusion and right sacroiliac arthrodesis. The patient has requested coverage for left sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient. | Upheld | Experimental | Summary Reviewer 2
The patient is a 45-year-old female with chronic low back pain, hip/buttock and tailbone pain and numbness and tingling above the knee. The onset of pain was atraumatic and began in November 2013. On 6/07/18, her pain was rated at 7 to 9/10 and was getting worse. She is status post L3-4 lumbar fusion and right sacroiliac arthrodesis. The patient has requested coverage for left sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient. The available medical literature states that sacroiliac fusion may be recommended on a case-by-case basis as a last line of therapy (including either open or minimally invasive procedures) as treatment for sacroiliac joint infection, tumor involving the sacrum, disabling pain due to sacroiliitis due to spondyloarthropathy, or sacroiliac pain due to severe traumatic injury. The procedure may be required for multisegmental spinal constructs (i.e., scoliosis or kyphosis surgery). However, it is not recommended for mechanical low back pain, non-specific low back pain, sacroiliac joint disruption (in the absence of major pelvic fracture), degenerative sacroiliitis, or sacroiliac joint osteoarthritis. In this case, the submitted records do not indicate the patient has been diagnosed with the conditions which have quality evidence to support benefit from sacroiliac fusion. Thus, the superior efficacy of left sacroiliac joint fusion has not been established. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 26-year-old female who presented for an admission assessment at a residential
treatment center (RTC) on 12/31/22. The patient has requested reimbursement for residential
substance abuse treatment at Harmony Place from 1/25/22 through 2/9/22.
For dimension 1, the patient underwent withdrawal management for opioid and alcohol withdrawal
earlier in her treatment stay. The patients withdrawal needs were safely managed in a Level 3.5
setting.
For dimension 2, the patient has fibromyalgia, lupus, and chronic pain. The patients biomedical
problems were stable and did not require 24-hour medical or nurse monitoring.
For dimension 3, the patient was diagnosed with PTSD, depression, and anxiety. She reported
anxiety, intrusive memories of past trauma, and was noted by staff on multiple occasions to have
difficulty with emotional dysregulation. The records noted that the patient had been using
substances to manage difficult emotions since adolescence, drinking since age 15, escalating to
Xanax by age 17 to escape painful thoughts, and further escalating to methamphetamine and heroin
use. The records noted a history of blackouts and of being victimized during a blackout. The
patients mental status was stable enough to permit participation. She demonstrated a repeated
inability to control her impulses to use substances and was in imminent danger of relapse with
attendant likelihood of harm to self, with a resulting level of dysfunction so severe that it precluded
the patient's participation in a less structured treatment environment.
For dimension 4, the patient was admitted voluntarily for treatment after relapsing | Overturned | Medical Necessity | Summary Reviewer
The patient is a 26-year-old female who presented for an admission assessment at a residential
treatment center (RTC) on 12/31/22. The patient has requested reimbursement for residential
substance abuse treatment at Harmony Place from 1/25/22 through 2/9/22. The physician reviewer
found that per American Society of Addiction Medicine (ASAM) criteria, this patient met Level
3.5 criteria for RTC services from 1/25/22 through 2/9/22. ASAM criteria focuses on six
dimensions to determine the appropriate level of care, which includes: (1) intoxication and
withdrawal potential; (2) biomedical conditions; (3) emotional, behavioral and cognitive
conditions; (4) readiness to change; (5) relapse, continued use, or continued problem potential; and
(6) recovery environment.
For dimension 1, the patient underwent withdrawal management for opioid and alcohol withdrawal
earlier in her treatment stay. The patients withdrawal needs were safely managed in a Level 3.5
setting.
For dimension 2, the patient has fibromyalgia, lupus, and chronic pain. The patients biomedical
problems were stable and did not require 24-hour medical or nurse monitoring.
For dimension 3, the patient was diagnosed with PTSD, depression, and anxiety. She reported
anxiety, intrusive memories of past trauma, and was noted by staff on multiple occasions to have
difficulty with emotional dysregulation. The records noted that the patient had been using
substances to manage difficult emotions since adolescence, drinking since age 15, escalating to
Xanax by age 17 to escape painful thoughts, and further escalating to methamphetamine and heroin
use. The records noted a history of blackouts and of being victimized during a blackout. The
patients mental status was stable enough to permit participation. She demonstrated a repeated
inability to control her impulses to use substances and was in imminent danger of relapse with
attendant likelihood of harm to self, with a resulting level of dysfunction so severe that it precluded
the patient's participation in a less structured treatment environment.
For dimension 4, the patient was admitted voluntarily for treatment after relapsing following
discharge from another treatment program. Although she requested treatment, she was often
noncompliant with medication recommendations and was often late to groups. The records noted
a review by administration due to the degree of the patients noncompliance with the program. She
was assessed as having limited recognition of the severity of her addiction and not fully ready to
give up her previous lifestyle. The records noted consistent substance use since age 15, which had
affected the patients cognitive ability to regulate her emotions and tolerate distress. Due to the
intensity and chronicity of the addictive disorder, the patient had limited insight and little
awareness of the need for continuing care or the existence of her substance use and need for
treatment, and thus had limited readiness to change.
For dimension 5, this was the patients fourth attempt at treatment. She reported using heroin and
methamphetamine intravenously daily. She had relapsed immediately after discharge from a
program in December, using substances until she was admitted to the RTC. She was unemployed
due to her substance use. She had a troubled relationship with her family due to her substance use,
had been kicked out of the home, and was living in her car. She was in an abusive relationship
with the individual who introduced her to substances, remaining in contract with and failing to
recognize this individual as a trigger for relapse. The patient did not recognize relapse triggers and
had little awareness of the need for continuing care and was therefore not committed to treatment.
Her continued substance use posed an imminent danger of harm to self or others in the absence of
24-hour monitoring and structured support. For dimension 6, the patient was homeless and living in her car after being kicked out of the family
home. She was unemployed due to her substance use. She did not have a sober support system and
had relapsed immediately after discharge from a prior program. She had an abusive ex-partner who
used drugs that she remained in contact with. The patient was unable to cope, for even limited
periods of time, outside of 24-hour care. She needed staff monitoring to learn to cope with
problems before being transferred safely to a less intensive setting.
Given these findings, the patient met the six ASAM criteria for RTC services provided from
1/25/22 through 2/9/22. Accordingly, residential substance abuse treatment at Harmony Place from
1/25/22 through 2/9/22 were medically necessary for treatment of this patient. | 1 |
A 24-year-old female enrollee has requested reimbursement for 83993 (fecal calprotectin) provided on 1/30/18. 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 diarrhea. | Upheld | Experimental | Summary Reviewer 1
A 24-year-old female enrollee has requested reimbursement for 83993 (fecal calprotectin) provided on 1/30/18. 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 diarrhea. The physician reviewer found that Calprotectin is a zinc and calcium binding protein that is derived mostly from neutrophils and monocytes. It can be detected in stool, making it a valuable marker of neutrophil activity. Fecal calprotectin levels are increased in intestinal inflammation and may be useful for distinguishing inflammatory from noninflammatory causes of chronic diarrhea. Fecal calprotectin can be considered as an adjunctive test in diagnostic evaluation of patients with chronic diarrhea. Therefore, for 83993 (fecal calprotectin) provided on 1/30/18 was likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 57-year-old male enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees severe, persistent asthma. | Upheld | Experimental | Summary Reviewer 1
A 57-year-old male enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees severe, persistent asthma. The physician reviewer found that in the peer-reviewed medical literature, Torrego and colleagues found that bronchial thermoplasty for patients with moderate to severe asthma provides a modest clinical benefit in quality of life and lower rates of asthma exacerbation, but no significant difference in asthma control scores. Weschler and colleagues noted that the long-term safety and effectiveness in patients with severe persistent asthma showed at five years durability of benefits of bronchial thermoplasty in regards to asthma control and safety persisted. However, in this case, the record fails to demonstrate any recent severe exacerbations or emergency department visits. The most recent notes state that the patients disease is stable. All told, the requested bronchial thermoplasty 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.
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A 52-year-old female enrollee has requested reimbursement for gene testing (unlisted multianalyte assay with algorithmic analysis) performed on 12/21/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 52-year-old female enrollee has requested reimbursement for gene testing (unlisted multianalyte assay with algorithmic analysis) performed on 12/21/18. 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 Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, gene testing (unlisted multianalyte assay with algorithmic analysis) performed on 12/21/18 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 49-year-old female enrollee has requested authorization and coverage for the Flexitouch pneumatic compression pump. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees lymphedema swelling status post mastectomy. | Upheld | Medical Necessity | Summary Reviewer
A 49-year-old female enrollee has requested authorization and coverage for the Flexitouch pneumatic compression pump. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees lymphedema swelling status post mastectomy. The physician reviewer found that the Flexitouch pneumatic compression system is not medically necessary for diagnosis and treatment of this patients medical condition. A review of the literature reveals that there is insufficient evidence to recommend the Flexitouch pneumatic compression system over conventional lymphedema pumps. Wilburn and colleagues compared the Flexitouch with conventional maintenance therapy and revealed that further investigation was needed. Ridner and colleagues reported that the positive results suggest that further investigation will be useful. Fife and colleagues compared treatment with the Flexitouch system with the Biocompression Systems Sequential Circulator. The authors reported statistically significant between-group differences in two of these both favoring treatment with the Flexitouch system. However, the study by Fife and colleagues was limited by its small sample size, missing data on the local tissue water outcome, and unclear blinding of outcome assessment. Additionally, the outcomes reported were primarily volume of fluid removed, which is an intermediate outcome. Pilch and colleagues compared lymphedema pumps in terms of number of chambers and cycle times and noted that overall there was not a significant difference among groups. Without sufficient evidence in the literature for the requested device and without evidence of failed conservative management, the requested Flexitouch pneumatic compression pump is not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested device is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 66-year-old female enrollee has requested authorization and coverage for Embeda. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees neuropathic pain.
Nucynta has a drug interaction with Cymbalta which can cause serotonin syndrome. She has tried morphine and oxycodone previously, without benefit. | Overturned | Medical Necessity | Summary Reviewer
A 66-year-old female enrollee has requested authorization and coverage for Embeda. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees neuropathic pain. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. Nucynta has a drug interaction with Cymbalta which can cause serotonin syndrome. She has tried morphine and oxycodone previously, without benefit. It is not medically reasonable to try a medication that she has previously failed. Since she is stable on Embeda, it is medically appropriate to continue on this medication. The use of strong opioids for neuropathic pain is supported by clinical practice guidelines. Thus, Embeda 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 33-year-old female enrollee has requested reimbursement for homocysteine testing, Factor V Leiden genetic testing and methylenetetrahydrofolate reductase (MTHFR) performed on 8/7/15. The Health Insurer has denied this request indicating that the services at were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 33-year-old female enrollee has requested reimbursement for homocysteine testing, Factor V Leiden genetic testing and methylenetetrahydrofolate reductase (MTHFR) performed on 8/7/15. The Health Insurer has denied this request indicating that the services at were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that The American College of Obstetricians and Gynecologists (ACOG) practice bulletin for inherited thrombophilias in pregnancy indicate that testing for inherited thrombophilias in women who have experienced recurrent fetal loss or placental abruption is not recommended because it is unclear if anticoagulation therapy reduces recurrence. Although there may be an association in these cases, there is insufficient clinical evidence that antepartum prophylaxis with unfractionated heparin or low molecular weight heparin (LMWH) prevents recurrence in these patients. In addition, there is insufficient evidence of an association and, therefore, insufficient evidence to either screen for or treat women with inherited thrombophilias and obstetric histories that include complications such as fetal growth restriction or preeclampsia. Moreover, there is a lack of medical literature supporting an association between the Factor V Leiden mutation and heritable thrombophilias and either pregnancy loss or obstetric complications characterized by placental insufficiency. Therefore, homocysteine testing, Factor V Leiden genetic testing and MTHFR performed on 8/7/15 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 services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 58-year-old female enrollee has requested reimbursement and prospective authorization and coverage for percutaneous tibial nerve stimulation (PTNS) provided from 1/22/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees overactive bladder. The physician reviewer found the records document that this patient has a diagnosis of refractory overactive bladder. She has failed multiple second- and third-line therapies and is not a candidate for certain therapies including sacral neuromodulation as noted by the provider. She has responded to PTNS. | Overturned | Medical Necessity | Summary Reviewer
A 58-year-old female enrollee has requested reimbursement and prospective authorization and coverage for percutaneous tibial nerve stimulation (PTNS) provided from 1/22/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees overactive bladder. The physician reviewer found the records document that this patient has a diagnosis of refractory overactive bladder. She has failed multiple second- and third-line therapies and is not a candidate for certain therapies including sacral neuromodulation as noted by the provider. She has responded to PTNS. Continued treatment with PTNS is medically necessary, and a nationally accepted standard of care for this patient. The procedure for PTNS consists of the insertion of a needle above the medial malleolus into the posterior tibial nerve followed by the application of low-voltage electrical stimulation that produces sensory and motor responses. The recommended course of treatment is an initial series of 12 weekly office-based treatments followed by an individualized maintenance treatment schedule. Evidence from multiple randomized placebo-controlled trials supports the safety and clinical efficacy of PTNS. The available 12- to 36-month evidence appears consistent with maintained efficacy in relieving symptoms of overactive bladder (OAB) and urinary voiding dysfunction. The American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU) guidelines support use of PTNS as third-line treatment in a carefully selected patient population with overactive bladder. Given that this patient has been treated with multiple second- and third-line therapies and is not a candidate for sacral neuromodulation, the PTNS provided from 1/22/16 forward was and is medically necessary for treatment of this patients refractory overactive bladder. Based on the foregoing discussion, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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The patient is an 11-year-old female with short stature. The patientas parent has requested authorization and coverage for Nutropin AQ Nuspin. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.
This patient was growing along the 5th percentile from age 4 years and was subsequently started on growth hormone therapy. She has a good IGF-1 generation on growth hormone treatment. This patient exhibited signs of growth failure before the growth hormone treatment was started. Per the
documentation, she had a good response to growth hormone therapy in terms of growth | Overturned | Medical Necessity | Summary Reviewer
The patient is an 11-year-old female with short stature. The patientas parent has requested authorization and coverage for Nutropin AQ Nuspin. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. The physician reviewer found that there is sufficient support for the requested medication in this clinical setting. This patient was growing along the 5th percentile from age 4 years and was subsequently started on growth hormone therapy. She has a good IGF-1 generation on growth hormone treatment. This patient exhibited signs of growth failure before the growth hormone treatment was started. Per the submitted documentation, she had a good response to growth hormone therapy in terms of growth velocity. Continuation of growth hormone therapy is medically appropriate in this case. Therefore, Nutropin AQ Nuspin is medically necessary for the treatment of this patient. | 1 |
A 26-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees alopecia areata. | Overturned | Experimental | Summary Reviewer 1
A 26-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees alopecia areata. The physician reviewer found that Alopecia areata is a chronic immunological disorder characterized by round or oval patches of non-scarring hair loss. Other autoimmune diseases are also linked with alopecia areata. Treatment is challenging and aims at the regrowth (reconstruction) of hair. Alopecia areata causes dramatic and devastating emotions in patients, which can negatively impact their self-esteem, body image, and self-confidence. Xeljanz (tofacitinib citrate) has been approved for the treatment of moderate to severe rheumatoid arthritis. It has been also studied for treatment of psoriasis, inflammatory bowel disease, and other immunological diseases. Several recent reports in the literature provide evidence for the effectiveness of this medication in the treatment of alopecia areata. Therefore, Xeljanz 5 mg is likely to be superior over 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.
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A 64-year-old female enrollee has requested reimbursement for collagen crosslinks testing performed on 11/18/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis. | Overturned | Experimental | Summary Reviewer 2
A 64-year-old female enrollee has requested reimbursement for collagen crosslinks testing performed on 11/18/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the services at issue. This patient has been taking Tymlos. In this clinical setting, a dual-energy x-ray absorptiometry (DEXA) is appropriate at the end of the two-year treatment to assess the patients response to therapy. The value of monitoring therapy with the use of biochemical markers of bone turnover to aid in clinical decision making is controversial. The test performed can be variable and subject to timing, dietary intake as well as lack of assay standardization. In sum, collagen crosslinks testing performed on 11/18/17 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 67-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees bilateral sacroiliac joint pain status post revision lumbar surgery. | Upheld | Experimental | Summary Reviewer 1
A 67-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees bilateral sacroiliac joint pain status post revision lumbar surgery. The physician reviewer found that according to the coverage criteria by the International Society for the Advancement of Spine Surgery (ISASS), the criteria for sacroiliac joint fusion have not been met in this patients case. The patients records do not include documentation of failure to respond to at least six months of non-surgical treatment consisting of non-steroidal anti-inflammatory drugs and/or opioids and one or more of the following: rest; physical therapy; or sacroiliac joint steroid injection must be reported. Moreover, there must be evidence that additional or alternative diagnoses that could be responsible for the patients ongoing pain or disability have been ruled out. Thus, although the patient has demonstrated continued pain that interferes with activities of daily living and results in functional disability, the patient has not adequately satisfied all of the ISASS criteria. All told, the requested sacroiliac joint fusion is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested service is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 42-year-old male enrollee has requested authorization and coverage for the prescription medication Skyrizi 150 mg syringe. 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. | Overturned | Medical Necessity | Summary Reviewer
A 42-year-old male enrollee has requested authorization and coverage for the prescription medication Skyrizi 150 mg syringe. 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 according to the American Academy of Dermatology and the National Psoriasis Foundation, two leading authorities on psoriasis treatment, Skyrizi is a safe, effective and well-tolerated treatment of chronic plaque psoriasis. It is an immunoglobulin G (IgG) monoclonal antibody that neutralizes IL-17 and as such does not seem to have a significant effect on the pathogenesis of coronavirus infections. It is recommended as monotherapy for treatment of psoriasis. Methotrexate is an antimetabolite which can also work in treating psoriasis, but the efficacy and onset of action are not as good as compare with biologics. Cyclosporine is only a short-term treatment for a chronic disease and would not be appropriate. Acitretin has inferior efficacy and risk profile to some of the biologic treatments. There is sufficient support for the requested medication in this clinical setting. Therefore, the prescription medication Skyrizi 150 mg syringe is medically necessary for the treatment of this patient. | 1 |
The patient is a 49-year-old male with a history of chronic low back pain. On 7/30/20, the records noted that the patient has a displaced lumbar disc and left lumbar radiculitis.
this case, the patient has a confirmed diagnosis of generalized anxiety disorder for which he is receiving medical treatment. The provider notes stated that the patient would undergo a lumbar epidural steroid injection but
that the patient suffered a severe case of vasovagal response during a lumbar medial branch block that was completed under local anesthetic only. He | Overturned | Medical Necessity | Summary Reviewer
The patient is a 49-year-old male with a history of chronic low back pain. On 7/30/20, the records noted that the patient has a displaced lumbar disc and left lumbar radiculitis. The physician reviewer found that the 2019 American Society of Interventional Pain Physicians (ASIPP) guidelines for use of sedation during routine pain management injections states, aGiven that patients undergoing pain procedures typically are anxious and in pain, mild to moderate sedation is acceptable for many patients.a The guidelines further state, aDeeper sedation should only be undertaken in the presence of anesthesia providers and for patients who have high anxiety, complex pharmacotherapy, or a low pain threshold when undergoing more painful interventional pain procedures. In special cases, the risk of patient movement during a procedure resulting in potential inadvertent injury may justify a deeper anesthetic state.a
The American Society of Anesthesiologists also published a statement regarding the use of sedation for pain management injections and concluded, aSignificant anxiety may be an indication for moderate (conscious) sedation or anesthesia services. In addition, procedures that require the patient to remain motionless for a prolonged period of time and/or remain in a painful position may require sedation or anesthesia services.a
In this case, the patient has a confirmed diagnosis of generalized anxiety disorder for which he is receiving medical treatment. The provider notes stated that the patient would undergo a lumbar epidural steroid injection but would require sedation because of a fear of needles. There is documentation from 2/16/18 showing that the patient suffered a severe case of vasovagal response during a lumbar medial branch block that was completed under local anesthetic only. He has a confirmed diagnosis of anxiety and known needle phobia which would make it difficult for him to undergo the epidural injection while remaining motionless. He also has a history of vasovagal response to previous injections done under local anesthetic only. Based on the medical records for review and current national guidelines, the request for monitored anesthesia care for the lumbar epidural steroid injection was medically indicated. Therefore, anesthesia for diagnostic or therapeutic nerve blocks and injections provided on 7/30/20 was medically necessary for the treatment of this patient. | 1 |
The patient is a 61-year-old male who underwent a colonoscopy for the indication of colorectal cancer screening on 3/22/21, with monitored anesthesia care. The patient has requested reimbursement for monitored anesthesia care provided on 3/22/21. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 61-year-old male who underwent a colonoscopy for the indication of colorectal cancer screening on 3/22/21, with monitored anesthesia care. The patient has requested reimbursement for monitored anesthesia care provided on 3/22/21. The physician reviewer found according to the ASA guidelines for anesthesia care during endoscopic procedures, monitored anesthesia care is warranted in prolonged or painful procedures, such as complex polyp resections, endoscopic retrograde cholangiopancreatography or other biliary procedures, endoscopic dilation, or endoscopic resection. Additionally, the guidelines state that monitored anesthesia care is more likely necessary in patients with a failed history of moderate sedation for the procedure or psychological impediments to cooperation. The provided records do not support any of these criteria, or other criteria in the literature, such as difficult intubation, airway obstruction, allergies to sedation medications, chronic alcohol or illicit drug use resulting in increased tolerance to sedation medications, age greater than 70, pregnancy, increased aspiration risk, ASA class III or higher, or morbid obesity. According to the most recent guidelines from the American Society for Gastrointestinal Endoscopy, during endoscopic procedures (unlike surgery) consciousness during the procedure is acceptable and is the goal during most procedures (which are performed with amoderate sedationa), and monitored anesthesia care is recommended for prolonged procedures requiring deep sedation, previously anticipated intolerance to standard sedatives, ASA class IV or V, or risk for airway obstruction due to anatomic variant. For these reasons, the submitted records do not support the medical necessity of monitored anesthesia care over conscious sedation in this case. Therefore, monitored anesthesia care provided on 3/22/21 was not medically necessary for the treatment of this patient. | 1 |
A 21-year-old female has requested reimbursement for Anser IFX testing performed on 8/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. | Upheld | Experimental | Summary Reviewer 1
A 21-year-old female has requested reimbursement for Anser IFX testing performed on 8/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found there is a lack of support for the services at issue in this clinical setting. There is a lack of prospective controlled data to support random measurement of Remicade/Remicade antibody levels. The concept of targeted drug level monitoring is supported for several classes of drugs. However, evidence is lacking for biologic agents in the treatment of this patients condition. There are multiple variables which drug level monitoring does not consider, thus making this line of testing suboptimal. For example, the optimal trough level of Remicade remains unknown and likely varies from individual to individual based on unique pharmacokinetics. Additionally, tissue levels of drug also play an important role. Therefore, Anser IFX testing performed on 8/17/15 was not likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 60-year-old male enrollee has requested reimbursement for Oncotype DX prostate cancer assay (CPT code 84999) testing provided on 4/11/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees elevated prostate-specific antigen (PSA). | Overturned | Experimental | Summary Reviewer 1
A 60-year-old male enrollee has requested reimbursement for Oncotype DX prostate cancer assay (CPT code 84999) testing provided on 4/11/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees elevated prostate-specific antigen (PSA). The physician reviewer found that Oncotype DX prostate cancer testing provides valuable information to help the patient and provider to make a decision whether to provide watchful waiting or proceed with surgery or radiation therapy. The Oncotype DX is clinically indicated to guide management of the patients prostate cancer and is the standard of care in this patient population. All told, the Oncotype DX prostate cancer assay (CPT 84999) testing performed on 4/11/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 32-year-old female enrollee has requested authorization and coverage for Gamunex-C. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition.
with seronegative polyarthritis presented with a six-year history of erythromelalgia with recurrent bouts of painful erythema and triggered by minor trauma.
, the patient has debilitating small fiber polyneuropathy with laboratory evidence of autoimmunity as well as clinical symptoms | Overturned | Experimental | Summary Reviewer 1
A 32-year-old female enrollee has requested authorization and coverage for Gamunex-C. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the standard treatment of small fiber neuropathy is dependent on the underlying etiology as well as treatment of associated neuropathic pain, which can include several different classes of
medications. In small fiber neuropathy, current neuropathic pain treatment options are generally insufficient to relieve the pain substantially. Small fiber polyneuropathy has various underlying causes, including associations with systemic autoimmune conditions. Intravenous immunoglobulin (IVIG) is a first-line treatment for immune-mediated neuropathies, such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy.
Erythromelalgia is a rare disorder that is characterized by erythematous, warm, painful extremities, which is often precipitated by cold conditions. The pathophysiology of erythromelalgia is incompletely understood. In a case study by Moody and colleagues, a patient with seronegative polyarthritis presented with a six-year history of erythromelalgia with recurrent bouts of painful erythema and triggered by minor trauma. Several medical therapies provided limited and inconsistent relief of her symptoms over many years. Treatment with intravenous immunoglobulin significantly decreased the frequency and severity of her symptoms. In this case, the patient has debilitating small fiber polyneuropathy with laboratory evidence of autoimmunity as well as clinical symptoms consistent with erythromelalgia. She has tried and failed conventional medical therapy. Based on the current medical evidence, patients with autoimmune small fiber neuropathy and erythromelalgia may improve clinically with intravenous immunoglobulin. Therefore, Gamunex-C is likely to be more beneficial than other available treatment options.
| 1 |
A 53-year-old female enrollee has requested authorization and coverage for a powered upper extremity range of motion assist device, elbow, wrist, hand, finger, single or double upright(s), including microprocessor, sensors, all components and accessories, custom fabricated. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 3
A 53-year-old female enrollee has requested authorization and coverage for a powered upper extremity range of motion assist device, elbow, wrist, hand, finger, single or double upright(s), including microprocessor, sensors, all components and accessories, custom fabricated. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that a review of the literature reveals that there are few studies on the myoelectric elbow-wrist-hand orthosis, and the outcomes of the studies are inconsistent. The literature reveals that further studies with larger numbers of participants are needed that show consistent improvements in relevant outcome measures. Additionally, the studies performed were inconsistent with variations between the trials in the intensity, duration, and amount of training; type of treatment; participant characteristics; and measurements used. A literature review by Carey evaluating the differences in myoelectric and body-powered upper limb prostheses revealed conflicting evidence in terms of the relative functional performance of body-powered and myoelectric prostheses. The authors noted, aBody-powered prostheses have been shown to have advantages in durability, training time, frequency of adjustment, maintenance, and feedback; however, they could still benefit from improvements of control. Myoelectric prostheses have been shown to improve cosmesis and phantom-limb pain and are more accepted for light intensity work.a The authors reported that the current evidence is insufficient to conclude that either system provides a significant general advantage. Additionally, this study indicates that there is a lack of empirical evidence regarding functional differences in upper-limb prostheses. McCabe and colleagues indicated that a small retrospective chronic stroke study did reveal gains made on a measure of upper limb motor control. This study was limited by inconsistent timing of testing and variability in treatment dose. The authors noted that additional measurements across multiple domains are necessary to further elucidate how the device impacts patient care and functional performance. All told, the requested powered upper extremity range of motion assist device, elbow, wrist, hand, finger, single or double upright(s), including microprocessor, sensors, all components and accessories, custom fabricated is not likely to be more beneficial than any available standard therapy.
| 1 |
The patient is a 59-year-old male with a history of obstructive sleep apnea (OSA). A home sleep study on 9/29/16 revealed an obstructive apnea index of 1.5 and a hypopnea index of 1.5 with a total apnea/hypopnea index (AHI) score of 2.9, and a supine AHI score of 0.0. A dental device did
the patients sleep apnea or snoring. A second home sleep study on 4/10/17 demonstrated a rise in both an obstructive apnea index of 2.9 and a hypopnea index of 10.2 with a total AHI score of 13.1. The results revealed a supine AHI of 24.6. The patient was provided with an oral appliance. The patient has requested reimbursement for an oral appliance provided on 12/6/16. The Health Insurer has denied this request indicating that the device at issue was not medically necessary.
. The patients polysomnogram on 4/12/17 revealed findings consistent with moderate-to-severe OSA syndrome. Moreover, the results revealed a supine AHI of 24.6. As the patient was found to have moderate-to-severe supine and positional OSA syndrome, | Overturned | Medical Necessity | Summary Reviewer
The patient is a 59-year-old male with a history of obstructive sleep apnea (OSA). A home sleep study on 9/29/16 revealed an obstructive apnea index of 1.5 and a hypopnea index of 1.5 with a total apnea/hypopnea index (AHI) score of 2.9, and a supine AHI score of 0.0. A dental device did not alleviate the patients sleep apnea or snoring. A second home sleep study on 4/10/17 demonstrated a rise in both an obstructive apnea index of 2.9 and a hypopnea index of 10.2 with a total AHI score of 13.1. The results revealed a supine AHI of 24.6. The patient was provided with an oral appliance. The patient has requested reimbursement for an oral appliance provided on 12/6/16. The Health Insurer has denied this request indicating that the device at issue was not medically necessary. Consistent with the recommendations from the American Academy of Sleep Medicine (AASM) and American Academy of Dental Sleep Medicine (AADSM), the oral appliance provided to this patient with OSA was medically necessary. The patients polysomnogram on 4/12/17 revealed findings consistent with moderate-to-severe OSA syndrome. Moreover, the results revealed a supine AHI of 24.6. As the patient was found to have moderate-to-severe supine and positional OSA syndrome, the oral appliance provided on 12/6/16 was medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the device at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The patient is a 45-year-old female who had been trying to conceive for greater than six months, without success. Her work-up was suggestive of diminished ovarian reserve. The patient has requested reimbursement for infertility services provided from 2/08/19 through 2/11/19. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 45-year-old female who had been trying to conceive for greater than six months, without success. Her work-up was suggestive of diminished ovarian reserve. The patient has requested reimbursement for infertility services provided from 2/08/19 through 2/11/19. The physician reviewer found that infertility is defined as a condition in an individual who is unable to conceive or produce conception during a period of six months in a female over the age of 35 years. In this case, in vitro fertilization would not be considered medically necessary due to its low likelihood to achieve pregnancy in a then 44-year-old patient. Increasing maternal age negatively impacts the live birth rate after embryo transfer when the patients own eggs are used. This effect is particularly pronounced for women age 40 and greater. After age 43, the Centers for Disease Control and Prevention indicates that the probability of live birth is 5.7 percent. Thus, many clinics will not provide in vitro fertilization to women using autologous oocytes after the 44th birthday when the live birth rate declines further to 4.6 percent. Thus, infertility services provided from 2/08/19 through 2/11/19 were not medically necessary for the treatment of this patient. | 1 |
A 31-year-old male enrollee has requested reimbursement for mental health outpatient services provided at a frequency of one time per week from 12/20/18 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions.
The medical records indicate that the patient has been receiving therapy on outpatient basis. The progress notes do not describe suicidal or homicidal ideation. He continues to have anxiety as well as functional impairment due to his generalized anxiety disorder.
. The patient has anxiety symptoms that have continued over several months, and the progress notes indicate episodes of increased anxiety. He has been receiving therapy, but his symptoms have shown only mild improvement as evidenced by continued anxious affect and symptom report. | Overturned | Medical Necessity | Summary Reviewer
A 31-year-old male enrollee has requested reimbursement for mental health outpatient services provided at a frequency of one time per week from 12/20/18 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The medical records indicate that the patient has been receiving therapy on outpatient basis. The progress notes do not describe suicidal or homicidal ideation. He continues to have anxiety as well as functional impairment due to his generalized anxiety disorder. Functional impairment must be present in order for a set of symptoms to classify as a mental illness. The patient has anxiety symptoms that have continued over several months, and the progress notes indicate episodes of increased anxiety. He has been receiving therapy, but his symptoms have shown only mild improvement as evidenced by continued anxious affect and symptom report. The medical evidence supports the services at issue in this clinical setting. Therefore, mental health outpatient services provided from 12/20/18 forward were and are medically necessary for the treatment of this patient. | 1 |
A 57-year-old female requested reimbursement for magnetic resonance imaging (MRI) provided on 9/2/16.The Health Insurer has denied this request and reported that the service at issue was considered investigational for evaluation of the enrollee who has a history of breast cysts. | Upheld | Experimental | Summary Reviewer 2
A 57-year-old female requested reimbursement for magnetic resonance imaging (MRI) provided on 9/2/16.The Health Insurer has denied this request and reported that the service at issue was considered investigational for evaluation of the enrollee who has a history of breast cysts. The physician reviewer found that according to the American College of Radiology appropriateness criteria for breast MRI, there is no data to support the use of breast MRI in the evaluation of breast pain as it does not meet the risk/benefit criteria. Cyclical pain is almost always due to hormonal fluctuation. The appropriate imaging examination for breast pain is mammography with possible ultrasound. Regarding the use of screening MRI for high risk patients, it is recommended for those patients with BRCA genetic mutations and their untested first degree relatives, women with additional genetic syndromes which increase the risk of breast cancer, women with a lifetime risk of greater than 20% and women who have received radiation therapy to the chest between the ages of 10 and 30. According to these criteria, this patient does not qualify for high risk MRI screening, as her lifetime risk is less than 20%. The patient has documented breast cysts on ultrasound. As such, MRI is not indicated for further evaluation of cysts. Diagnostic mammography with ultrasound is the appropriate imaging test for further evaluation of breast lumps/cysts. Therefore, in this patients case, MRI performed on 9/2/16 was not likely to have been more beneficial for the evaluation of this patients condition than the available standard imaging.Based upon the information set forth above, the service at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 57-year-old female enrollee has requested reimbursement for comprehensive cancer genomic panel provided on 5/9/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectal carcinoma. | Overturned | Experimental | Summary Reviewer 3
A 57-year-old female enrollee has requested reimbursement for comprehensive cancer genomic panel provided on 5/9/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectal carcinoma. The physician reviewer found that to demonstrate clinical utility of panel testing for somatic genomic alterations, such as FoundationOne, 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 insufficient to make conclusions on clinical utility. All told, the comprehensive cancer genomic panel provided on 5/9/17 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 male enrollee has requested reimbursement for laboratory testing on 12/2/22. The Health
Insurer has denied this request and reported that services at issue were investigational for the
evaluation of the enrollees premature coronary artery disease and hyperlipidemia. | Overturned | Experimental | Summary Reviewer 2
A 48-year-old male enrollee has requested reimbursement for laboratory testing on 12/2/22. The Health
Insurer has denied this request and reported that services at issue were investigational for the
evaluation of the enrollees premature coronary artery disease and hyperlipidemia. The physician
reviewer found that in this clinical setting, lipoprotein(a) testing was likely to have been more beneficial
for the assessment and management of dyslipidemia compared to standard lipid panel testing alone.
Despite the proven clinical utility of standard lipid testing for risk management, there remains a
significant risk of atherosclerotic cardiovascular disease (ASCVD) events. In a meta-analysis of statin
trials examining major cardiovascular disease (CVD) events during five years of follow-up, Nacimento
Harada and colleagues report that this residual risk is noted to be as high as 21.7% in secondary
prevention patients and 9.5% in primary prevention patients. Advanced lipoprotein assays have been
proposed for improving the assessment of cardiovascular risk and guiding lipid-modifying therapy.
Wilson and colleagues explain that lipoprotein(a) is a form of low-density lipoprotein (LDL) associated
with apolipoprotein(a), a unique protein attached to the apolipoprotein B segment of LDL. The authors
further noted, Numerous studies provide strong evidence of a causal link between elevated
lipoprotein(a) and myocardial infarction, ischemic stroke, valvular aortic stenosis (VAS), coronary artery
stenosis, carotid stenosis, femoral artery stenosis, heart failure, cardiovascular mortality, and all-cause
mortality. The relationships are independent of LDL cholesterol (LDL-C) or other lipid concentrations.
The American Heart Association (AHA) and American College of Cardiology (ACC) guidelines on the
management of blood cholesterol state that measuring lipoprotein(a) is reasonable in patients with a
family history of premature ASCVD or personal history of ASCVD not explained by major risk factors, as it
can provide more detailed risk assessment. The ACC/AHA guidelines on the primary prevention of
cardiovascular disease note that lipoprotein(a) increases ASCVD risk, especially at higher levels. Thus, in
patients with a lipoprotein(a) equal to or greater than 50 mg/dL or 125 nmol/L, lipoprotein(a) may be
considered a risk-enhancing factor. The importance of clinical risk enhancers lies in their potential
influence on the threshold for pharmacologic therapy initiation or intensification. Mach and colleagues note that while there are currently no targeted treatments to lower lipoprotein(a) that have
demonstrated impact on CVD outcomes or disease progression, there are phase II trials that have shown
that treatment with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor therapy may lead to
a lipoprotein(a) reduction of about 30% to 40%. Therefore, patients on statin therapy who have elevated
lipoprotein(a) are the most likely to receive benefit from more aggressive LDL-C lowering therapy,
including ezetimibe or PCSK9 inhibitors. In these select groups, lipoprotein(a) levels may be useful in
reclassifying ASCVD risk and in aiding in decisions regarding pharmacotherapy. Overall, there is sufficient
support in peer-reviewed literature for the use of advanced lipoprotein testing with lipoprotein(a) in
certain patients in whom the results may refine risk assessment. The additional insights provided by the
measurement of lipoprotein(a) have the potential to further clarify estimations of ASCVD risk and alter
medical management in this select group of patients. As such, the service at issue was likely to have
been more beneficial for the enhanced risk stratification and aid in therapeutic decision-making than
standard lipid panel testing alone in this patient with SLE, hyperlipidemia, and severe premature
coronary artery disease status post coronary artery bypass grafting, on high-intensity statin therapy.
Therefore, laboratory testing on 12/2/22 was likely to have been more beneficial for the evaluation of
the patients condition than any available standard therapy.
| 1 |
A 61-year-old male enrollee has requested reimbursement for gene expression profiling performed on 5/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 61-year-old male enrollee has requested reimbursement for gene expression profiling performed on 5/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. The patients risk for bladder cancer and prior history are unknown. The test is designed to detect bladder cancer and is a surveillance test that is proposed to be an adjunct to cystoscopy to rule out bladder cancer in patients with increased risk. In this patients case, the stage is unknown. At this time, the CxBladder gene expression test does not appear to be a standard of medical care. Medical evidence does not support its routine use. Thus, gene expression profiling performed on 5/10/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 31-year-old female has requested reimbursement for lab tests that measure the levels of
medication, adalimumab (ADA) performed on 8/1/22. The Health Insurer has denied this request
indicating that the testing at issue was considered investigational for evaluation of the insureds
ulcerative colitis. | Overturned | Experimental | Summary Reviewer 3
A 31-year-old female has requested reimbursement for lab tests that measure the levels of
medication, adalimumab (ADA) performed on 8/1/22. The Health Insurer has denied this request
indicating that the testing at issue was considered investigational for evaluation of the insureds
ulcerative colitis. The physician reviewer found that on review of the current peer-reviewed
medical literature, the drug assay testing for ADA performed on 8/1/22 was likely to be more
beneficial for the evaluation of this patient than any available standard therapy. The drug testing
performed was reactive drug monitoring since the test was recommended in response to the
patients symptoms of ulcerative colitis. The most recent national guideline from the AGA
specifically endorses reactive drug monitoring in this clinical setting when the patient has
symptoms while on anti-TNF agents such as ADA (Feuerstein, et al.). The AGA guidelines cite
data that has shown that reactive drug monitoring is more beneficial than standard therapy
including change of drug therapy without the drug assay and is supported with consensus
agreement among experts (Feuerstein, et al.; Papamichael, et al.). Thus, the lab tests that measure
the levels of adalimumab performed on 8/1/22 was likely more beneficial for evaluation of the
patient than any available standard therapy.
| 1 |
The parent of a 16-year-old male enrollee has requested reimbursement for immunoassay for
analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise
specified and adalimumab on 8/6/21. The Health Insurer has denied this request indicating that the
service and medication at issue were investigational for the treatment of the enrollees ulcerative
colitis. | Overturned | Experimental | Summary Reviewer 2
The parent of a 16-year-old male enrollee has requested reimbursement for immunoassay for
analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise
specified and adalimumab on 8/6/21. The Health Insurer has denied this request indicating that the
service and medication at issue were investigational for the treatment of the enrollees ulcerative
colitis. The physician reviewer found that the current medical literature suggests that if there is
evidence of ongoing inflammation or active disease while on biologic therapy, testing of drug
antibodies and levels are useful in determining whether or not to make a drug change. In a
randomized controlled trial, Peyrin-Biroulet and colleagues report that Entyvio is more effective
than adalimumab in controlling severe ulcerative colitis. In this case, immunoassay or antibody
testing, not infectious agent otherwise specified, is more beneficial than the standard testing
including testing for C-reactive protein, or fecal calprotectin, or an elevated platelets count. The
results may inform the changing of a biologic medication from an anti-tumor necrosis factor (TNF)
agent, such as Humira, to a different class of biologic medication, such as Entyvio, an alpha-4
integrin receptor blocker that has been shown to be beneficial in this clinical setting. Therefore,
immunoassay for analyte other than infectious agent antibody or infectious agent antigen;
quantitative, not otherwise specified was likely to have been more beneficial for treatment of the
patient's condition than any available standard therapy. However, adalimumab on 8/6/21 was not
likely to have been more beneficial for treatment of the patient's condition than any available
standard therapy.
| 1 |
A 44-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with
dilation of eustachian tube (i.e. balloon dilation); bilateral on 7/6/21. The Health Insurer has denied
this request and reported that the service at issue was investigational for the treatment of the
enrollees bilateral chronic eustachian tube dysfunction. | Overturned | Experimental | Summary Reviewer 3
A 44-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with
dilation of eustachian tube (i.e. balloon dilation); bilateral on 7/6/21. The Health Insurer has denied
this request and reported that the service at issue was investigational for the treatment of the
enrollees bilateral chronic eustachian tube dysfunction. The physician reviewer found that the current
medical literature supports the use of eustachian tube balloon dilation in the setting of chronic
otitis media and eustachian tube dysfunction. The symptoms of obstructive eustachian tube
dysfunction include aural fullness, pressure, hearing loss, and otalgia. Eustachian tube dysfunction
is typically transient. For persistent eustachian tube dysfunction, nonsurgical medical management
consisting of nasal steroid spray or oral steroid, nasal sprays, or pressure equalization maneuvers
may suffice. Surgical management may consist of the placement of ear tubes in select cases, along
with eustachian tube dilation when needed. Once extrinsic causes of eustachian tube dysfunction
have been ruled out, and other common causes such as allergies, sinusitis, and laryngopharyngeal
reflux have been managed, eustachian tube dilation may be of significant benefit. In a systematic
review of eustachian tube balloon dilation for the treatment of eustachian tube dysfunction,
Froehlich and colleagues reported clinically significant improvement in both subjective and
objective criteria. In a study to assess balloon dilation of the eustachian tube with eustachian tube
balloon catheter in conjunction with medical management, Poe and colleagues concluded that the
study demonstrated the superiority of balloon dilation of the eustachian tube with balloon catheter
in addition to medical management over medical management alone with nasal and oral steroids
in the treatment of eustachian tube dilatory dysfunction in adults. Wang and colleagues report that
balloon dilation results in significant improvement of eustachian tube dysfunction over newer
techniques such as laser tuboplasty. In this case, notes dated 9/11/20 reported that the patient
underwent medical management with a nasal steroid spray and an oral antihistamine. When
medical management failed, the patient underwent the more conservative procedure of placement
of ear tubes. However, the patient continued to have symptoms and underwent eustachian tube
dilation. In this clinical setting, the service at issue was likely to have been more beneficial than
standard medical management, ear tube placements, and laser tuboplasty. Therefore,
nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e. balloon dilation); bilateral on
7/6/21 was likely to have been more beneficial for treatment of the patients condition than any
available standard therapy.
| 1 |
A 63-year-old female enrollee has requested authorization and coverage for acute rehabilitation admission. 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 been diagnosed with a stroke secondary to a subarachnoid hemorrhage affecting the left frontoparietal and temporal region, resulting in aphasia and right-sided paresis. The patient is right-sided dominant and is therefore limited from performing activities of daily living. | Overturned | Medical Necessity | Summary Reviewer
A 63-year-old female enrollee has requested authorization and coverage for acute rehabilitation admission. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested services in this clinical setting. This patient has been diagnosed with a stroke secondary to a subarachnoid hemorrhage affecting the left frontoparietal and temporal region, resulting in aphasia and right-sided paresis. The patient is right-sided dominant and is therefore limited from performing activities of daily living. She is likely to benefit from speech therapy as well as occupational and physical therapy services that would be provided in a rehabilitation facility. It has become the standard of care to refer patients who experience a stroke to a rehabilitation facility. Therefore, the requested acute rehabilitation admission is medically necessary for the treatment of this patient. | 1 |
A 60-year-old female enrollee has requested authorization and coverage for Xifaxan 500 mg. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician
that the patient had small intestinal bacterial overgrowth. | Overturned | Medical Necessity | Summary Reviewer
A 60-year-old female enrollee has requested authorization and coverage for Xifaxan 500 mg. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the patient had small intestinal bacterial overgrowth. Xifaxan has proven highly effective in small intestinal bacterial overgrowth for eradication of bacteria and symptom relief. The medication has been shown to have greater effectiveness with fewer side effects than antibiotic alternatives such as metronidazole, neomycin, and fluoroquinolones. Results are sustained for several weeks after treatment. Moraru and colleagues performed a prospective trial of patients with irritable bowel syndrome and small intestinal bacterial overgrowth. The authors found that 86% responded to Xifaxan, and symptoms were reduced as well. Xifaxan is effective for the treatment of constipation-predominant irritable bowel syndrome. In this case, while antispasmodic medications may address irritable bowel syndrome, they would not be expected to improve small intestinal bacterial overgrowth. Anti-diarrheal medications would not be appropriate in the use of constipation. Therefore, the use of Xifaxan 550 mg three times daily for 14 days is supported as medically necessary for the treatment of this patients small intestinal bacterial overgrowth in the setting of irritable bowel syndrome. | 1 |
A 59-year-old female enrollee has requested reimbursement for Avastin provided from 5/27/15 through 8/4/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees metastatic colorectal carcinoma. | Overturned | Medical Necessity | Summary Reviewer
A 59-year-old female enrollee has requested reimbursement for Avastin provided from 5/27/15 through 8/4/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees metastatic colorectal carcinoma. The physician reviewer found that in this case, chemotherapy is being used in the neoadjuvant setting. There is limited data on neoadjuvant chemotherapy since most patients in this clinical setting typically present with inoperable advanced disease. Neoadjuvant treatment is a medically reasonable approach in a patient with limited stage disease that is potentially operable (Assifi, et al; Andriulli, et al). The best chemotherapy options include gemcitabine or oxaliplatin or cisplatin combined with fluoropyrimidines, gemcitabine with Abraxane, gemcitabine with erlotinib, and gemcitabine with docetaxel and capecitabine (Ghosn, et al). In addition, Avastin did improve progression-free survival when combined with erlotinib and gemcitabine (Van Cutsem, et al). All told, there is adequate data supporting the medical necessity of the Avastin provided to this patient from 5/27/15 through 8/4/15.
Consistent with these findings, the medication at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The patient is a 13-year-old male who has been evaluated by a pediatric endocrinologist since 2014. In 2014, he displayed normal growth velocity and delayed bone age. The patients parent has requested authorization and coverage for Humatrope injection 24 mg. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.
His growth velocity and provoked growth hormone release are normal. His growth pattern and predicted adult height are consistent with his familial pattern. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 13-year-old male who has been evaluated by a pediatric endocrinologist since 2014. In 2014, he displayed normal growth velocity and delayed bone age. The patients parent has requested authorization and coverage for Humatrope injection 24 mg. 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 U.S. Food and Drug Administration (FDA) defines idiopathic short statute as height z-score below 2.25 standard deviations without apparent etiology after thorough professional evaluation. This patient does not meet these criteria. His growth velocity and provoked growth hormone release are normal. His growth pattern and predicted adult height are consistent with his familial pattern. His predicted adult height of 66.5-67 is within the normal range for adult men in North America. This patient not meet clinical criteria for an FDA-approved indication for somatotropin. Familial short stature with constitutional delay of growth and development is the most appropriate diagnosis as documented by the treating pediatric endocrinologist. Therefore, Humatrope injection 24 mg is not medically necessary for the treatment of this patient. | 1 |
The parent of a 17-year-old male enrollee has requested reimbursement for residential treatment center (RTC) services provided from 4/4/15 through 6/10/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees major depressive disorder, recurrent.
The patients history explained his lack of cooperation with therapy prior to admission. | Upheld | Medical Necessity | Summary Reviewer
The parent of a 17-year-old male enrollee has requested reimbursement for residential treatment center (RTC) services provided from 4/4/15 through 6/10/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees major depressive disorder, recurrent. The physician reviewer found that the submitted records from 4/4/15 through 6/10/15 fail to support the need for RTC level of care for treatment of this patients medical condition. The notes that were submitted contain little or no information about the patients behaviors or mental status. In addition, there is no documentation of any problem behaviors or medical problems. The patients history explained his lack of cooperation with therapy prior to admission. However, there was no stated reason for continuation of treatment as of 4/4/15. All told, the RTC services provided from 4/4/15 through 6/10/15 were not medically necessary for treatment of this patients behavioral health issues. 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 38-year-old male enrollee has requested authorization and coverage for sirolimus cream. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 2
A 38-year-old male enrollee has requested authorization and coverage for sirolimus cream. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that topical sirolimus offers superior benefit for the control and resolution of angiofibromas in tuberous sclerosis complex. There is robust evidence supporting the efficacy and safety of topical sirolimus, which targets the etiology of this rare genetic disorder. The alternative therapies of hyfrecation, shave removal or laser ablation all carry risks of permanent scarring and are less effective than topical sirolimus. All told, sirolimus cream is likely to be more beneficial than other available standard therapy.
| 1 |
The patient is a 60-year-old female with a history of hypertension, coronary artery disease with angina and anxiety who was admitted to the hospital at an inpatient level of care on 2/15/19 with a diagnosis of intractable left hip pain and left lower extremity pain. The patient has requested reimbursement for inpatient stay at Glendale Memorial Hospital from 2/15/19 through 2/20/19. The Health Plan has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 60-year-old female with a history of hypertension, coronary artery disease with angina and anxiety who was admitted to the hospital at an inpatient level of care on 2/15/19 with a diagnosis of intractable left hip pain and left lower extremity pain. The patient has requested reimbursement for inpatient stay at Glendale Memorial Hospital from 2/15/19 through 2/20/19. The Health Plan has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that most people with acute or subacute musculoskeletal pain will improve over time regardless of treatment. Per Qaseem and colleagues, clinicians and patients should select non-pharmacologic treatment with superficial heat, massage, acupuncture, or spinal manipulation over pharmacologic intervention. The authors noted, aIf pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants.a Patients with chronic pain are recommended to participate in rehabilitation, exercise and other non-pharmacologic modalities. Per the authors, if pharmacologic therapy is indicated, then treatment with nonsteroidal anti-inflammatory drugs are a first-line therapy, or tramadol or duloxetine as a second-line therapy for chronic pain. In this patientas case, the inpatient admission was not medically necessary. Inpatient care is necessary when the patientas signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting, when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. At the time of admission, she was hemodynamically stable without any physical findings or symptoms concerning for a neurologic emergency, such as cauda equina syndrome. She was able to void and ambulate with assistance from her husband. She required pharmacologic treatment of acute pain in the hip and low back, but her pain improved with treatment. Her cardiac status remained stable, without any evidence of acute coronary syndrome. She was discharged home with plans for outpatient physical therapy. Therefore, inpatient stay at Glendale Memorial Hospital from 2/15/19 through 2/20/19 was not medically necessary for the treatment of this patient.
| 1 |
A 57-year-old female enrollee has requested authorization and coverage for (azithromycin) Zithromax. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 57-year-old female enrollee has requested authorization and coverage for (azithromycin) Zithromax. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found Zithromax is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases. The documentation submitted for review does not support these indications for use of Zithromax in this patients case. Moreover, there is a lack of medical literature for the use of Zithromax in gastrointestinal disease. The medical literature available for the use of Zithromax in gastrointestinal disease was for Parkinsons disease associated with gastroparesis and small bowel bacterial overgrowth, neither of which has been documented in the patients clinical documentation. For the reasons provided, the patients request for (azithromycin) Zithromax has not been established as medically necessary. For the reasons provided, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 20-year-old male with a history of urinary frequency, urgency, and nocturia. The patient has been treated with Ditropan, which was discontinued for constipation, and Myrbetriq, which provided minimal symptomatic improvement. The patient underwent the first of 12 scheduled percutaneous tibial nerve stimulation (PTNS) sessions on 10/16/17. The patient has requested reimbursement for 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 2
The patient is a 20-year-old male with a history of urinary frequency, urgency, and nocturia. The patient has been treated with Ditropan, which was discontinued for constipation, and Myrbetriq, which provided minimal symptomatic improvement. The patient underwent the first of 12 scheduled percutaneous tibial nerve stimulation (PTNS) sessions on 10/16/17. The patient has requested reimbursement for PTNS provided on 10/16/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational. PTNS is considered third-line therapy in the current medical literature. The use of physical therapy or physical therapy combined with medication has been demonstrated to be more efficacious in the peer-reviewed medical literature. PTNS may be indicated in lieu of more invasive neuromodulation therapy to avoid implantable sacral nerve modulation in well selected patients. However, there is a lack of support for treatment with PTNS for this patient given the available standard therapies. All told, 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 45-year-old female enrollee has requested reimbursement and prospective authorization and coverage for IVIG (Octagam) from 4/29/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollee, who has symptoms of distal sensory paresthesias, fatigue and weakness in the lower extremities.
In this particular case, the patient carries the diagnosis of CIDP and has had a reported benefit of her clinical symptoms in response to this therapy. | Overturned | Medical Necessity | Summary Reviewer
A 45-year-old female enrollee has requested reimbursement and prospective authorization and coverage for IVIG (Octagam) from 4/29/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollee, who has symptoms of distal sensory paresthesias, fatigue and weakness in the lower extremities. The physician reviewer found that the medical literature support the services at issue in this clinical setting. Although IVIG is not indicated for all cases of neuropathy, it is indicated for patients diagnosed with CIDP and in some cases, those patients with autoimmune disease. In this particular case, the patient carries the diagnosis of CIDP and has had a reported benefit of her clinical symptoms in response to this therapy. The medical literature demonstrates the benefit of IVIG in patients with CIDP. To undertreat an autoimmune neuropathy would place the patient at risk of significant clinical decline and functional impairment. In this patients case, the continued use of IVIG is medically indicated, given her medical history. As such, IVIG (Octagam) from 4/29/16 forward was and is medically necessary. Therefore, for the reasons stated above, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old male enrollee has requested authorization and coverage for 18F-NaF positron emission tomography/computed tomography (PET/CT) scan. The Health Insurer has denied this request indicating that the requested diagnostic procedure is considered investigational for evaluation of the enrollees prostate cancer. | Overturned | Experimental | Summary Reviewer 2
A 60-year-old male enrollee has requested authorization and coverage for 18F-NaF positron emission tomography/computed tomography (PET/CT) scan. The Health Insurer has denied this request indicating that the requested diagnostic procedure is considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found that in the medical literature, Jadvar and colleagues reported that in patients with relapsed prostate cancer, 18F-NaF PET/CT is useful in the detection of occult osseous metastases, whereas the yield of 18F-FDG PET/CT is relatively limited. Poulsen and colleagues found that 18F-NaF PET/CT were superior to whole body scintigraphy with regard to detection of prostate cancer bone metastases within the spine. Thus, the literature does support 18F-NaF PET/CT to be superior to bone scan with regards to detection of prostate cancer bone metastases within the spine. Further, the requested 18F-NaF PET/CT is the most reliable tool when there is high index of suspicion for osseous metastases. Consistent with this support, the requested 18F-NaF PET/CT scan is likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the requested diagnostic procedure is likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old male enrollee has requested reimbursement for the fecal calprotectin testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees Crohns disease. | Overturned | Experimental | Summary Reviewer 3
A 60-year-old male enrollee has requested reimbursement for the fecal calprotectin testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found fecal calprotectin has commonly been used practice given the multiple studies showing its beneficial effect and accuracy. Since the patients calprotectin was low, the provider focused his attention on a different diagnosis than Crohns flare, thus sparing additional, and more invasive testing that would not have been beneficial. Based on clinical utility that has been documented in multiple clinical trials, the fecal calprotectin testing performed on 11/17/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 57-year-old female insured has requested reimbursement for a blood test performed on
3/7/23. The Health Insurer has denied this request indicating that the service at issue was
considered investigational for the evaluation of the insureds rheumatoid arthritis. | Upheld | Experimental | Summary Reviewer 2
A 57-year-old female insured has requested reimbursement for a blood test performed on
3/7/23. The Health Insurer has denied this request indicating that the service at issue was
considered investigational for the evaluation of the insureds rheumatoid arthritis. The physician
reviewer found that there are a lack of established medical trials comparing the use and efficacy
of the Vectra DA blood test with standard clinical disease activity assessments, including the DAS
28-CRP, for patients with rheumatoid arthritis. Further study is required to validate the efficacy
of multi-biomarker blood tests. The National Institute for Health and Care Excellence (NICE)
recommends monthly monitoring of C-reactive protein and disease activity until remission or low
disease activity, measured by DAS 28 scoring. NICE does not mention biomarker tests in its
recommendations. Overall, there is insufficient evidence to support the use of multi-biomarker
blood tests such as the Vectra DA blood test for the evaluation of this patients rheumatoid
arthritis. Given these findings, the blood test performed on 3/7/23 was not likely to have been
more beneficial for the evaluation of the patients condition than any available standard therapy.
| 1 |
The patient is a 51-year-old male who presented to his provider on 5/11/21 for evaluation of chronic low back pain with associated acute bilateral L5-S1 radiculopathy. The patient has requested authorization and coverage for MRI of the lumbar spine. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of this patient.
This patient presented with low back pain with associated radiculopathy symptoms. He | Overturned | Medical Necessity | Summary Reviewer
The patient is a 51-year-old male who presented to his provider on 5/11/21 for evaluation of chronic low back pain with associated acute bilateral L5-S1 radiculopathy. The patient has requested authorization and coverage for MRI of the lumbar spine. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. According to the American College of Radiology, if lower back pain persists after four to six weeks of conservative management, and the patient is a surgical or intervention candidate, then MRI of the lumbar spine is the usually appropriate next exam. This patient presented with low back pain with associated radiculopathy symptoms. He failed conservative management in the past per the patientas provider, including physical therapy. Therefore, MRI of the lumbar spine is an appropriate exam and could change the patientas management, which may include surgical intervention or interventions such as pain management. Therefore, the requested MRI of the lumbar spine is medically necessary for the evaluation of this patient.
| 1 |
A 66-year-old male enrollee has requested authorization and coverage for Viagra 100mg tablets. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees erectile dysfunction | Upheld | Medical Necessity | Summary Reviewer
A 66-year-old male enrollee has requested authorization and coverage for Viagra 100mg tablets. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees erectile dysfunction The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested medication. Both Viagra and Levitra are phosphodiesterase inhibitors which are used to treat erectile dysfunction. Per the medical evidence, both drugs have a similar mechanism of action and pharmacokinetics. The current medical literature does not support significant differences in efficacy between the two medications. In this patients case, treatment with Levitra is medically appropriate. All told, Viagra 100mg tablets are not medically indicated for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be
upheld.
| 1 |
A 28-year-old male enrollee has requested reimbursement for ColonSentry testing (CPT code 81479) performed on 10/23/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 28-year-old male enrollee has requested reimbursement for ColonSentry testing (CPT code 81479) performed on 10/23/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition. The physician reviewer found the review of the submitted documentation and relevant literature fails to support the services at issue in this clinical setting. Serum biomarkers for colon cancer screening are not recommended by the National Comprehensive Cancer Network (NCCN) guidelines for colorectal cancer (CRC) screening (Provenzale, et al). According to Fletcher The New York State Department of Health also approved a seven-gene test (ColonSentry) in February 2012 to be used to identify patients at increased risk of colorectal cancer in order to target such patients for monitoring to assure compliance with regular colonoscopy. However, it has not been shown that the test can detect early-stage cancers, for which screening would be most effective, and test sensitivity (61 to 82 percent) and specificity (64 to 77 percent) were only fair for CRC at any stage when tested in populations that included a substantial proportion of patients with known CRC. Based on the lack of support in the peer-reviewed literature, the ColonSentry testing (CPT code 81479) performed on 10/23/14 was not likely to be more beneficial for evaluation of the patients medical condition than other modalities. 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 55-year-old female enrollee has requested authorization and coverage for corticotropin (Acthar Gel). The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition.
This patient has not exhausted all other possible therapies for rheumatoid arthritis, and the medical records do not
that the patient has failed each therapy reported to have been tried and failed. | Upheld | Experimental | Summary Reviewer 1
A 55-year-old female enrollee has requested authorization and coverage for corticotropin (Acthar Gel). The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested medication in this clinical setting. This patient has not exhausted all other possible therapies for rheumatoid arthritis, and the medical records do not clearly document that the patient has failed each therapy reported to have been tried and failed. Acthar Gel has not been proven to be superior to alternative therapies, such as prednisone or methylprednisolone, in terms of efficacy or safety for the long-term management of rheumatoid arthritis. Since Acthar Gel exerts at least some of its anti-inflammatory effects through corticotrophin receptors, Acthar Gel carries the same potential risks as steroids, including diabetes.
H.P. Acthar has a corticotropin effect and with that, the same potential side effect profile as steroids with respect to osteoporosis, glaucoma, cataracts, weight gain, increased blood pressure, and glucose intolerance. Therefore, corticotropin (Acthar Gel) is not likely to be more beneficial than other treatment options.
| 1 |
A 49-year-old female enrollee has requested reimbursement for a digital breast tomosynthesis that was performed on 3/22/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for the enrollees breast examination | Overturned | Experimental | Summary Reviewer 3
A 49-year-old female enrollee has requested reimbursement for a digital breast tomosynthesis that was performed on 3/22/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for the enrollees breast examination The physician reviewer found Breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. In this particular patient, her breasts have been described as extremely dense. It is specifically those patients who have dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. Therefore, digital breast tomosynthesis performed on 3/22/16 was likely to have been of greater benefit than other modalities for evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned
| 1 |
A 27-year-old female enrollee has requested authorization and coverage for E1399 durable
medical equipment RT300 FES arm therapy system. The Health Insurer has denied this request
and reported that the requested device is investigational for the treatment of the enrollees
medical condition. | Upheld | Experimental | Summary Reviewer 2
A 27-year-old female enrollee has requested authorization and coverage for E1399 durable
medical equipment RT300 FES arm therapy system. The Health Insurer has denied this request
and reported that the requested device is investigational for the treatment of the enrollees
medical condition. The physician reviewer found that the E1399 RT300 FES arm therapy system
is not likely to be more beneficial than other available standard therapy. It is uncertain whether
FES can restore upper-extremity function or improve the quality of life. The evidence is
insufficient to determine the effects of the technology on health outcomes. The evidence for the
effectiveness of the RT300 FES cycling in people with stroke is limited. There is insufficient
evidence in the literature that supports that the use of the RT300 FES will be effective for this
patients hemiplegia from stroke in long-term improvement of muscle strength, vascular blood
flow, bone mineral density, reduction of spasticity and atrophy, facilitation of functional motor
movement or reduction muscle atrophy in the upper and lower extremities. Eraifej and
colleagues performed a meta-analysis of 20 studies on the benefits of FES on activities of daily
living. Only three studies showed a significant benefit of FES on activities of daily living when
initiated within two months post-stroke. In three studies where FES was initiated more than one
year after stroke, no significant activities of daily living improvements were seen. Limitations of
the evaluable studies included, very low quality evidence in all analyses due to heterogeneity, low participant numbers and lack of blinding. The authors concluded that FES is a promising
therapy that could play a part in future stroke rehabilitation. They noted that there is a need for
high quality large-scale randomized controlled trials of upper limb FES after stroke to draw firm
conclusions regarding its efficacy or its optimum therapeutic window. The evidence that FES
cycling can have a long-term effect on bone mineral density is not found in the literature. An
additional study done on the prevention and treatment of osteoporosis by Soleyman-Jahi and
colleagues revealed very low-quality evidence that low-intensity cycling (three days per week)
with FES provided a benefit for reducing bone mineral density loss in individuals with chronic
spinal cord injury or neurologic injury. All told, the current medical evidence has not
demonstrated the superior efficacy of the requested device. Therefore, the requested for E1399
durable medical equipment RT300 FES arm therapy system is not likely to be more beneficial
than any available standard therapy.
| 0 |
The patient is a 57-year-old male with amyloidosis. He was diagnosed with AL amyloidosis caused by a kappa light chain plasma cell neoplasm. His disease manifestations included restrictive cardiomyopathy, syncope, dyspnea, carpal tunnel syndrome, and dysrhythmia. He was treated with bortezomib, cyclophosphamide, and dexamethasone. His free light chains increased after this treatment suggesting progressive disease. The patient has requested authorization and coverage for daratumumab (Darzalex). The Health Insurer has denied this request indicating that the requested medication is considered investigational. Primary amyloidosis | Overturned | Experimental | Summary Reviewer 3
The patient is a 57-year-old male with amyloidosis. He was diagnosed with AL amyloidosis caused by a kappa light chain plasma cell neoplasm. His disease manifestations included restrictive cardiomyopathy, syncope, dyspnea, carpal tunnel syndrome, and dysrhythmia. He was treated with bortezomib, cyclophosphamide, and dexamethasone. His free light chains increased after this treatment suggesting progressive disease. The patient has requested authorization and coverage for daratumumab (Darzalex). The Health Insurer has denied this request indicating that the requested medication is considered investigational. Primary amyloidosis due to immunoglobulin light chains and multiple myeloma are both plasma cell neoplasms. Both diseases are the result of cancerous plasma cells that are secreting paraproteins. In AL amyloidosis, the plasma cells involving the bone marrow are fewer in number than in multiple myeloma and the light chains have the protein characteristic of forming amyloid in tissues. In this case, there is no standard approach. Darzalex is a monoclonal antibody directed against CD38. It was approved by the U.S. Food and Drug Administration (FDA) for treatment of myeloma in patients who have progressed on proteasome inhibitor or immunomodulatory agents. Moreover, Darzalex has been shown to be effective against AL amyloidosis (Kaufman, et al). For these reasons, the requested Darzalex is supported as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
| 1 |
A 56-year-old female enrollee has requested reimbursement for magnetic resonance imaging (MRI) of the lumbar spine provided on 10/27/17. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary for evaluation of the enrollees left-sided back and hip pain. | Upheld | Medical Necessity | Summary Reviewer
A 56-year-old female enrollee has requested reimbursement for magnetic resonance imaging (MRI) of the lumbar spine provided on 10/27/17. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary for evaluation of the enrollees left-sided back and hip pain. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The American College of Radiology (ACR) indicates that MRI is not warranted in the acute setting. However, in the setting of low back pain in which the patient is a candidate for surgery or other intervention, then the ACR considers MRI to be the most appropriate study, with no stipulation about delaying the MRI. In 2007, Chou and colleagues noted that clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain. Per the authors clinicians should evaluate patients with persistent low back pain and signs or symptoms of radiculopathy or spinal stenosis with magnetic resonance imaging (preferred) or computed tomography only if they are potential candidates for surgery or epidural steroid injection (for suspected radiculopathy). In general, plain x-rays are often of very limited value. Plain x-rays serve to evaluate the patient for significant structural abnormalities, such as fractures, malalignments or congenital anomalies. However, plain x-rays are not generally beneficial for evaluating the patient for a cause for radiculopathy. Patients can have significant disc herniations with normal plain x-rays; and conversely, patients with significant degenerative change in the lumbar spine may not have significant disc encroachment. Most importantly, many patients have radiographic and/or MRI evidence of degenerative changes with apparent disc herniations, and are asymptomatic. Thus, radiographic findings do not necessarily correlate with clinical symptoms, and it is imperative that decisions are based on symptoms. There is a lack of support for the diagnostic procedure at issue in this patients case. The only reason to obtain an MRI is in anticipation of some sort of intervention. This could be surgery, but it could also involve facet injections. Prior to an intervention, it is not unreasonable to attempt a trial of conservative treatment, such as physical therapy, a targeted exercise program, or methodical use of anti-inflammatory drugs. In sum, MRI of the lumbar spine provided on 10/27/17 was not medically necessary. Therefore, the diagnostic procedure at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 30-year-old female enrollee has requested reimbursement for extended inpatient stay at Sharp Memorial Hospital provided from 11/04/17 through 11/06/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer
A 30-year-old female enrollee has requested reimbursement for extended inpatient stay at Sharp Memorial Hospital provided from 11/04/17 through 11/06/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that postoperative ileus is a delay in the return of gastrointestinal motility after surgery, and is common after colectomy. It can result in nausea, abdominal pain, absence of flatus, and absence of bowel movements, all of which this patient had. Postoperative ileus is the main determinant of the length of stay after colorectal surgery. Postoperative ileus can justify an extended length of stay after surgery. Additionally, given the risk for post-colectomy complications, a prolonged postoperative ileus raises concerns for complications such as leak or intra-abdominal infection, supporting the inpatient level of care until ileus had resolved in this case. These concerns are heightened in patients with possible Crohns disease, especially those on anti-tumor necrosis factor medications. Therefore, the extended inpatient stay provided from 11/04/17 through 11/06/17 was medically necessary for the treatment of this patient. | 0 |
A 29-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 3
A 29-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the LINX Reflux Management System works by augmenting the lower esophageal sphincter with a ring of magnets. Eligible patients must demonstrate typical gastroesophageal reflux disease symptoms, an abnormal pH study, partial response to daily proton pump inhibitor (PPI) therapy, and absence of a large hiatal hernia or severe esophagitis. This patient meets all of these criteria. In the study by Ganz and colleagues, the long-term safety and efficacy of the LINX prosthesis was evaluated in a prospective single-group trial of 100 patients with longstanding gastroesophageal reflux disease. At five years after LINX, significantly fewer patients reported moderate or severe heartburn (12 versus 89 percent), moderate or severe regurgitation (1 versus 57 percent), bothersome gas-bloat (8 versus 52 percent), and daily PPI use (15 versus 100 percent). No device erosions, migrations, or malfunctions occurred. The ability to belch or vomit, when needed, was preserved in all patients. The medical evidence supports the requested services in this patientas case. Therefore, the requested LINX procedure is likely to be more beneficial than any available standard therapy.
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A 21-year-old male enrollee has requested reimbursement for substance use partial hospitalization provided on 10/12/17 and from 11/17/17 through 12/08/17 and substance use intensive outpatient program services provided from 12/09/17 through 1/11/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. | Upheld | Medical Necessity | Summary Reviewer
A 21-year-old male enrollee has requested reimbursement for substance use partial hospitalization provided on 10/12/17 and from 11/17/17 through 12/08/17 and substance use intensive outpatient program services provided from 12/09/17 through 1/11/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that in cases such as this, an evidence-based, objective, instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) is indispensable in determining necessary and appropriate level of care for adults. With regards to risk of harm, the records support a score of 1 due to a lack of current suicidal ideation and no self-harming behaviors or history of suicide attempts. In terms of functional status, the records support a score of 2 to 3 due to school problems and daily substance use that impacted motivation. With regards to medical, addictive and psychiatric comorbidity, the records support a score of 2 due to overall medical stability. In terms of level of stress of the recovery environment, the records support a score of 3. With regards to level of support of the recovery environment, the records support a score of 2 due to family support and availability of treatment resources. In terms of treatment and recovery history, the records support a score of 3 due to lack of past recent intensive treatment. In terms of engagement and recovery status, the records support a score of 2 due to cooperation in treatment and insight into his need for treatment. Thus, the patient has a composite score of 15 to 16. This score correlates with treatment in a community-based outpatient clinic setting. This patient could have received effective treatment on an outpatient basis, due to his lack of self-harm behaviors, cooperative behaviors, and lack of active suicidal or homicidal ideation. He was motivated for treatment with mention of insight into his illness as well as documentation of his knowledge of skills to maintain sobriety. The submitted documentation does not indicate that he was having severe mood swings or other severe psychiatric symptoms. Thus, substance use partial hospitalization provided on 10/12/17 and from 11/17/17 through 12/08/17 and substance use intensive outpatient program services provided from 12/09/17 through 1/11/18 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 0 |
A 22-year-old male has requested reimbursement for Prometheus Anser IFX testing performed on 8/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.T | Upheld | Experimental | Summary Reviewer 3
A 22-year-old male has requested reimbursement for Prometheus Anser IFX testing performed on 8/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.The physician reviewer found the Prometheus Anser IFX test was ordered to direct the use of Remicade (infliximab) in this patient with Crohns disease. However, the use of the testing at issue to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. Therefore, it is unclear whether dosage should be increased, the medication should be changed, or another course of action should be taken. Although loss of response to infliximab is common, there were no standard guidelines defining a therapeutic strategy at the time of testing. Thus, Prometheus Anser IFX testing performed on 8/30/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 50-year-old male has requested authorization and coverage for the LINX Reflux Management System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease.
troesophageal reflux disease and a hiatal hernia less than 3 cm. | Upheld | Experimental | Summary Reviewer 1
A 50-year-old male has requested authorization and coverage for the LINX Reflux Management System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease. The physician reviewer found the U.S. Food and Drug Administration has approved the LINX Reflux Management System for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate gastroesophageal reflux disease and a hiatal hernia less than 3 cm. This patient meets those specific criteria. The device is a ring made up of a series of magnets that have sufficient attraction to increase the lower esophageal sphincter closure pressure, but allow for food passage with swallowing. Based upon a prospective study by Lipham and colleagues which included 44 patients, the mean total percent time pH less than 4 was reduced from 11.9 percent at baseline to 3.8 percent at three years. A recent study comparing the LINX procedure with laparoscopic fundoplication was performed by Reynolds and colleagues. This was a retrospective study which used propensity matching to compare groups. The authors found that gastroesophageal reflux disease patients had similar control of reflux symptoms after both LINX and fundoplication. The inabilities to belch and vomit were significantly fewer with LINX, along with a significantly lower incidence of severe gas-bloat symptoms. In this patients case, the requested LINX Reflux Management System is likely to be superior over 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.
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A 36-year-old female enrollee has requested authorization and coverage for Qsymia. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees diabetes mellitus, hyperlipidemia. | Overturned | Medical Necessity | Summary Reviewer
A 36-year-old female enrollee has requested authorization and coverage for Qsymia. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees diabetes mellitus, hyperlipidemia. The physician reviewer found that obesity is recognized as a major risk factor for type 1 diabetes. In the peer-reviewed medical literature, data suggests that clinically meaningful weight loss, defined as greater than 5%, can lead to improved glycemic control in patients with type 2 diabetes. Moreover, this weight loss is likely to aid in the management of other comorbid conditions (Rejeski, et al). Qsymia is a medication that promotes weight loss and has been shown to improve other health parameters of obese patients, including type 2 diabetes (Mahgerefteh, et al). Given this support, the requested Qsymia is medically necessary for this patient. 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 55-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 11/2/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 55-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 11/2/15. 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 breast tomosynthesis performed on 11/2/15 was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. Ciatto and colleagues investigated the effect of integrated two dimensional (2D) and three dimensional (3D) mammography in the breast cancer screening population. The authors found that Integrated 2D and 3D mammography improves breast cancer detection and has the potential to reduce false positive recalls. Based on the documentation submitted for review and medical literature, the use of breast 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 services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 40-year-old male enrollee has requested authorization and coverage for Vemlidy. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis B infection. | Overturned | Medical Necessity | Summary Reviewer
A 40-year-old male enrollee has requested authorization and coverage for Vemlidy. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis B infection. The physician reviewer found the guidelines for the treatment of hepatitis B from the American Association for the Study of Liver Diseases (AASLD) recommend entecavir and tenofovir compared with alternatives for the treatment of chronic hepatitis B (Terrault, et al). In comparison with tenofovir disoproxil fumarate (Viread), which the patient is taking, the Vemlidy formulation of tenofovir is effective for hepatitis B, but is associated with lower incidence of side effects such as osteopenia and renal disease (Grant, et al). Although entecavir is also recommended by AASLD guidelines, the patient is stabilized on tenofovir, and a change to entecavir may result in disease reactivation. As such, the request for Vemlidy is demonstrated to be medically necessary for the treatment of this patients chronic hepatitis B. Therefore, for the reasons stated above, Vemlidy is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 65-year-old male has requested reimbursement for gene testing performed on 12/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer. | Overturned | Experimental | Summary Reviewer 1
A 65-year-old male has requested reimbursement for gene testing performed on 12/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. Once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features such as the grade of tumor and prostate specific antigen level. This helps guide the most appropriate therapy for patients taking into account their age and comorbidities because many patients will not require therapy and may be followed closely instead. The important features to recognize are Gleason score and prostate specific antigen levels, but these are imperfect. Thus, current biomarkers are inadequate for risk stratification, and better prognostic biomarkers are needed. The Oncotype DX prostate cancer test is a gene expression analysis of target genes in the biopsy specimen that generates a genomic prostate score (GPS). The medical evidence supports the services at issue in this clinical setting in order to better stratify such patients with localized disease. Therefore, gene testing performed on 12/09/15 was likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of a 14-year-old male enrollee has requested authorization and coverage for surgery for scoliosis. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
In this case, the patient has been diagnosed with idiopathic scoliosis with a 44 degree thoracic curve and 24 degree lumbar curve. | Upheld | Experimental | Summary Reviewer 2
The parent of a 14-year-old male enrollee has requested authorization and coverage for surgery for scoliosis. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that surgery for scoliosis has not been established as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Samdani and colleagues reviewed 32 patients who underwent a fusionless treatment of thoracic vertebral body tethering (VBT) with a minimum one-year follow-up. The authors concluded that that anterior VBT was a safe and potentially effective treatment option for skeletally immature patients with idiopathic scoliosis. However, the authors stated that longer term follow-up of this cohort will reveal the true benefits of this promising technique. In this case, the patient has been diagnosed with idiopathic scoliosis with a 44 degree thoracic curve and 24 degree lumbar curve. There is a lack of documentation of significant pain or current functional or activity limitation. In addition, there is a lack of evidence demonstrating an adequate trial of bracing as recommended by the treating provider has been tried. Finally, there is a lack of large volume, long-term peer-reviewed outcome studies to support the safety and effectiveness of vertebral body tethering at this time. In sum, the requested surgery for scoliosis is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 35-year-old female enrollee has requested authorization and coverage for polysomnography. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition.
patient is at intermediate risk for obstructive sleep apnea, which
her depression and anxiety. Per the records, she has symptoms of sleep apnea. | Overturned | Medical Necessity | Summary Reviewer
A 35-year-old female enrollee has requested authorization and coverage for polysomnography. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the patient is at intermediate risk for obstructive sleep apnea, which could contribute to her depression and anxiety. Per the records, she has symptoms of sleep apnea. The patient is not a good candidate for a home sleep study, given her intermediate risk with a high possibility of a false negative study. The patient will need an in-laboratory diagnostic polysomnography (95810) or split night sleep study (95811) to accurately evaluate and treat her sleep disorder breathing. Therefore, the requested polysomnography is medically necessary for the evaluation of this patient. | 1 |
A 61-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/19/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented for a breast examination. | Overturned | Experimental | Summary Reviewer 3
A 61-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/19/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented for a breast examination. The physician reviewer found that the Breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. However, in this patients case, there were no problems to be resolved. The patient did not have dense breasts, a mass, palpable lumps, or suspicious calcifications. In this clinical setting, a routine mammogram would have been sufficient. Digital breast tomosynthesis has not been shown to provide significant increased value in patients who do not have dense tissue that could obscure an abnormality. Therefore, breast tomosynthesis performed on 7/19/16 was not likely to have been of greater benefit than other modalities for evaluating this patient. Based upon the information set forth above, the service at issue was not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 54-year-old male enrollee has requested authorization and coverage for neurostimulator electrode array and pulse generator. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
that the patient has obstructive sleep apnea and has no nasal obstruction. Drug-induced sleep endoscopy showed no concentric collapse at velum and primarily anterior posterior collapse. The patient has not been able to tolerate the continuous positive airway pressure device. The Inspire | Overturned | Experimental | Summary Reviewer 2
A 54-year-old male enrollee has requested authorization and coverage for neurostimulator electrode array and pulse generator. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the patient has obstructive sleep apnea and has no nasal obstruction. Drug-induced sleep endoscopy showed no concentric collapse at velum and primarily anterior posterior collapse. The patient has not been able to tolerate the continuous positive airway pressure device. The Inspire device has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of obstructive sleep apnea. The patient is a candidate for the Inspire device, given the intolerance to continuous positive airway pressure, anterior posterior collapse, and body mass index and apnea-hypopnea index within FDA criteria. In sum, CPT codes 64568 and 0466T are likely to be more beneficial than other treatment options.
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The parent of a 15-year-old male enrollee has requested reimbursement for CPT code 95165, professional services for the suppression and provision of antigens for allergen immunotherapy from 2/10/15 through 2/12/15. The Health Insurer has denied this request indicating that the services at issue were investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
The parent of a 15-year-old male enrollee has requested reimbursement for CPT code 95165, professional services for the suppression and provision of antigens for allergen immunotherapy from 2/10/15 through 2/12/15. The Health Insurer has denied this request indicating that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found there is sufficient evidence in the medical literature to support the use of home allergy immunotherapy. The current medical evidence supports the services at issue in this patients case. Per the medical records, home administration of allergens immunotherapy was medically appropriate. Therefore, CPT code 95165, professional services for the suppression and provision of antigens for allergen immunotherapy from 2/10/15 through 2/12/15 was likely to have been more efficacious than other methods of treating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 66-year-old male enrollee has requested reimbursement for positron emission tomography (PET) scan performed on 9/06/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees tumor of suprahyoid epiglottis.
This patient was diagnosed with squamous cell carcinoma. The PET scan was medically | Overturned | Medical Necessity | Summary Reviewer
A 66-year-old male enrollee has requested reimbursement for positron emission tomography (PET) scan performed on 9/06/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees tumor of suprahyoid epiglottis. The physician reviewer found that the medical evidence supports the services at issue in this clinical setting. PET/CT has an important role in the diagnosis and treatment of head and neck cancer. The technique can aid in the detection of an unknown primary tumor, assist in locoregional staging, evaluate for distant metastases or second primary tumors, and be a component of restaging and tumor surveillance. PET/CT is also used for precise delineation of the tumor volume for radiation therapy planning, and for treatment response monitoring, by detecting residual or recurrent disease. This patient was diagnosed with squamous cell carcinoma. The PET scan was medically necessary for staging and treatment planning. Thus, PET scan performed on 9/06/18 was medically necessary for the evaluation of this patient. Therefore, the services at issue were medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 45-year-old male enrollee has requested authorization and coverage for maxillary and mandibular osteotomies with advancement. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees obstructive sleep apnea (OSA). | Upheld | Medical Necessity | Summary Reviewer
A 45-year-old male enrollee has requested authorization and coverage for maxillary and mandibular osteotomies with advancement. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees obstructive sleep apnea (OSA). The physician reviewer found that Maxillomandibular advancement can be an effective treatment for treatment of sleep disordered breathing based on several case series but more rigorous evaluation of the procedure is lacking (Prinsell). Current practice parameters list this procedure as an option for patients who cannot tolerate or who are unwilling to adhere to positive airway pressure therapy, or in whom oral appliances, which are more often appropriate in mild and moderate OSA patients, have been considered and found ineffective or undesirable (Aurora, et al). Traditionally, mandibular advancement devices have been used for mild to moderate sleep apnea. This patients provider states that a mandibular advancement device is not likely to be effective in treating the patients sleep apnea. However, the most recent guidelines do not exclude the use of maxillomandibular advancement in severe OSA (Ramar, et al). In summary, the patient does have severe OSA and is CPAP intolerant but he has not tried a mandibular advancement device, a treatment which could result in adequate control of his sleep disordered breathing. Since there is another reasonable, non-surgical option available to him, the requested maxillary and mandibular osteotomies with advancement are not medically necessary. Based on the foregoing discussion, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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An 18-year-old male enrollee has requested reimbursement for residential treatment from 7/01/15 through 7/31/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
who evaluated him during this time, the patient was likely to have relapsed into his previous behaviors if discharged to a lower level of care. The records describe the patient as superficial and able to present a false front to his treatment team. Thus, he was not internalizing the changes | Overturned | Medical Necessity | Summary Reviewer
An 18-year-old male enrollee has requested reimbursement for residential treatment from 7/01/15 through 7/31/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation supports the medical necessity of the services at issue. The current medical evidence supports residential treatment in this clinical setting. Per the documentation from his treatment providers, including the psychologist who evaluated him during this time, the patient was likely to have relapsed into his previous behaviors if discharged to a lower level of care. The records describe the patient as superficial and able to present a false front to his treatment team. Thus, he was not internalizing the changes needed to avoid a relapse. All told, residential treatment from 7/01/15 through 7/31/15 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.
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A 69-year-old female enrollee has requested reimbursement for lipoprotein (a) testing performed on 2/09/21. 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 69-year-old female enrollee has requested reimbursement for lipoprotein (a) testing performed on 2/09/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. At issue is whether the services at issue were likely to have been more beneficial for evaluation of the enrolleeas condition than any available standard therapy. The physician reviewer found that guidelines for the management of cardiac risk and dyslipidemia have been established, are periodically updated by expert committees and are endorsed by several national organizations. These guidelines currently do not recommend routine performance of specialized tests in the context of assessing coronary risk, including lipoprotein (a) testing. Treatment change or addition based on the results of screening with these specialized tests has not been shown to improve cardiac outcome incremental to that achievable by treatment based on standard risk factor profiling and basic lipid analysis. Therefore, lipoprotein (a) testing performed on 2/09/21 was not likely to have been more beneficial than other available methods of evaluating this patient.
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A 59-year-old female enrollee has requested reimbursement for Decision DX melanoma assay performed on 5/19/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 3
A 59-year-old female enrollee has requested reimbursement for Decision DX melanoma assay performed on 5/19/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the decision DX melanoma assay has been developed in patients with stage I and II cutaneous melanoma. However, 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 according to published data available. It does not aid in the decision for re-excision. In sum, Decision DX melanoma assay performed on 5/19/16 was not likely to be of greater benefit than available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 64-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/07/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees melanoma. | Upheld | Medical Necessity | Summary Reviewer
A 64-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/07/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees melanoma. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines indicate 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. The results of this testing were unlikely to have altered treatment and surveillance recommendations. Thus, DecisionDx-Melanoma testing performed on 2/07/18 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld. | 0 |
A 56-year-old female has requested reimbursement for percutaneous tibial nerve stimulation performed from 5/08/18 through 8/02/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of urinary frequency and urgency. | Upheld | Experimental | Summary Reviewer 1
A 56-year-old female has requested reimbursement for percutaneous tibial nerve stimulation performed from 5/08/18 through 8/02/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of urinary frequency and urgency. The physician reviewer found that percutaneous tibial nerve stimulation may have a role in reducing uninhibited bladder contractions when first-line behavior modification and second-line medical therapy have failed to resolve symptoms of overactive bladder. In this patients case, there is also the complexity of past interventions, ongoing neuropathic issues, and diabetes increasing the risk of urinary tract infections. It is not standard of care to proceed with percutaneous tibial nerve stimulation prior to exhausting standard first-line behavior modification and second-line medical therapy. Percutaneous tibial nerve stimulation has not be shown to be more effective than these treatment approaches per the current evidence. Therefore, percutaneous tibial nerve stimulation performed from 5/08/18 through 8/02/18 was not likely to have been of greater benefit than other available treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 51-year-old male enrollee has requested authorization and coverage for low back surgery to be done in two stages (stage 1, anterior lumbar fusion with one day stay followed by stage 2, posterior fusion also with one day stay). 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. | Overturned | Medical Necessity | Summary Reviewer
A 51-year-old male enrollee has requested authorization and coverage for low back surgery to be done in two stages (stage 1, anterior lumbar fusion with one day stay followed by stage 2, posterior fusion also with one day stay). 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 there is sufficient support for the requested services in this patients case. A review of the literature indicates moderate evidence of good outcomes from standalone lumbar fusions for chronic pain with or without instability. Degenerative disc and facet joint disease of the lumbar spine is common in individuals in this age group, and is one of the most frequent causes of pain and associated disability. Lumbar spondylosis may result in mechanical back pain, radicular pain, reduced mobility and poor quality of life. Surgical interbody fusion of degenerative levels is an effective treatment option to stabilize the painful motion segment, and may provide indirect decompression of the neural elements, restore lordosis and correct any associated deformity. The provider has suggested the fusion procedure at L4-5 in two stages due to the large size of the patient, which is reasonable, appropriate, and medically necessary in this case. Therefore, low back surgery to be done in two stages (stage 1, anterior lumbar fusion with one day stay, followed by stage 2, posterior fusion also with one day stay) is medically necessary for the treatment of this patient. | 1 |
A 47-year-old female enrollee has requested reimbursement for proton beam therapy provided on 5/20/19 through 7/12/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 47-year-old female enrollee has requested reimbursement for proton beam therapy provided on 5/20/19 through 7/12/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that standard treatment for rectal cancer is with photon techniques. Currently, there is a lack of clinical data in the medical literature to suggest that treatment with protons offers a clinical benefit compared to conventional radiation therapy techniques for tumors of the rectum. Consensus group guidelines do not support the use of proton therapy in this setting. Also, there is a lack of phase 3 studies that demonstrate proton therapy is associated with less side effects compared to standard therapy with photons in patient with pelvic malignancies. The dose comparison was reviewed as well and showed no clinically significant benefit with the use of protons over standard techniques, as all standard dose metrics are being met with the standard plan. Thus, proton beam therapy provided from 5/20/19 through 7/12/19 was not likely to have been more beneficial than other available treatment options.
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A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 2/6/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 2/6/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition. The physician reviewer found that the testing at issue was not likely to be more effective for this patient than other available options. Prometheus Anser IFX Test is a quantitative measurement of serum infliximab (IFX) and anti-IFX antibodies. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions, as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. Some evidence exists that low serum levels of infliximab or adalimumab or the presence of IFX or ADA antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, there are few well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. It has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. In sum, there is a lack of sufficient evidence in the peer-reviewed literature to establish the testing at issue as likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 35 hours per week of direct applied behavioral analysis (ABA) therapy and 3.5 hours per week of oversight provided from 7/1/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 35 hours per week of direct applied behavioral analysis (ABA) therapy and 3.5 hours per week of oversight provided from 7/1/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism. The physician reviewer found that in this clinical setting, ABA therapy is medically necessary for treatment of the patients medical condition. The study by Mohammadzaheri and colleagues found that ABA is effective for treating disruptive behaviors in school aged children with autism. Based on the documentation submitted for review, the patient requires a higher level of ABA therapy due to maladaptive behaviors including aggression, non-compliance, and a high level of self-injury. In addition, the patient has not mastered a majority of the goals included in the most recent progress report. In sum, the medical necessity for 35 hours per week of direct ABA therapy and 3.5 hours per week of oversight provided from 7/1/16 forward has been established as medically necessary for treatment of the patients medical condition. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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The patient is a 17-year-old female. Notes dated 1/24/21 reported that the patient had been home
for three months following discharge from a wilderness program. The patients parent has
requested reimbursement for mental health inpatient services from 1/24/21 through 7/19/21. The
Health Insurer has denied this request and reported that the services at issue were not medically
necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 17-year-old female. Notes dated 1/24/21 reported that the patient had been home
for three months following discharge from a wilderness program. The patients parent has
requested reimbursement for mental health inpatient services from 1/24/21 through 7/19/21. The
Health Insurer has denied this request and reported that the services at issue were not medically
necessary for the treatment of this patient. This denial is the subject of this appeal and
determination. The physician reviewer found that 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. Applying the CALOCUS-CASII framework, this patient met the criteria for mental health
inpatient services. With regard to risk of harm, the records support a score of 5. The patient had
an extreme risk of harm, due to current suicidal ideation with a plan. The patient had a history of
serious past suicide attempts and during the time period at issue relentlessly engaged in acutely
self-endangering behaviors including cutting, picking scabs, and using a plastic spoon to harm
herself, and required restraint from staff not to self-harm. In terms of functional status, the records
support a score of 4. The documentation noted serious functional impairment due to clear, serious
deterioration of interpersonal interactions with peers. She had consistent conflict with others,
including with staff and with her parents, and demonstrated highly impulsive behaviors.
With regard to comorbidity, the records support a score of 4. The patient had major comorbidity,
due to the presence of multiple psychiatric conditions that clearly impaired functioning, persisted
in the absence of stressors, and seriously impaired recovery from the presenting condition. These
included severely depressed mood, chronic suicidal ideation and suicidal behaviors, insomnia,
severe anxiety, and impulsivity secondary to ADHD. In terms of level of stress of the recovery
environment, the records support a score of 4. The patient had a highly stressful environment due
to serious and severe conflict in the home. With regard to level of support of the recovery
environment, the records support a score of 3 due to the patients family having limited ability to
respond appropriately to her developmental needs and/or problems. In terms of resiliency and
treatment history, the records support a score of 5. The patient had negligible resiliency and/or
response to treatment as past response to treatment was quite minimal, even at high levels of care
for extended periods of time. The patient had failed two RTC attempts, PHP, and had also failed
wilderness therapy. With regard to treatment acceptance and engagement, the records support a
score of 4. The patient had a difficult and unproductive relationship with clinicians and other care
providers. The patient did not accept age-appropriate responsibility in her role in the development,
perpetuation, or consequences of the problem, particularly in her suicidal ideation and self-harm behaviors. Thus, the patient has a total score of 29. In this case, the recommended level of care is
medically managed residence-based services. This is consistent with the level of care that the
patient received with mental health inpatient services. Therefore, mental health inpatient services
from 1/24/21 through 7/19/21 were medically necessary for the treatment of this patient.
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A 31-year-old female enrollee has requested authorization and coverage for exome sequence analysis (gene panel testing). The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 31-year-old female enrollee has requested authorization and coverage for exome sequence analysis (gene panel testing). The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that exome genetic sequencing has been shown to be beneficial for the purposes of genetic counseling and potential future disease modification. The medical evidence does not indicate therapies available for the treatment of cerebral palsy that are dependent upon the results of genetic sequencing. The general consensus with regard to genetic sequencing is that although very beneficial academically in terms of disease diagnosis, it has proven beneficial in disease management rarely. Therefore, the requested services are not likely to be of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the requested services are not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 14-year-old female enrollee has requested authorization and coverage for colon motility (manometric) study, minimum six hours continuous recording (including provocation tests, e.g., meal, intracolonic balloon distension, pharmacologic agents, if performed), with interpretation and report, procedure code 91117, and associated one day inpatient admission. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollee, who has a history of bowel incontinence. | Overturned | Experimental | Summary Reviewer 2
The parent of a 14-year-old female enrollee has requested authorization and coverage for colon motility (manometric) study, minimum six hours continuous recording (including provocation tests, e.g., meal, intracolonic balloon distension, pharmacologic agents, if performed), with interpretation and report, procedure code 91117, and associated one day inpatient admission. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollee, who has a history of bowel incontinence. The physician reviewer found that colonic manometry is indicated for the planning of surgical interventions in patients with constipation refractory to medical therapy. These interventions may include, but are not limited to, appendicostomy and cecostomy for antegrade enemas. Appendicostomy has been specifically mentioned as a consideration for this patients care. The utility of colonic manometry for this purpose has been described in the clinical literature. In sum, colon motility (manometric) study, minimum six hours continuous recording (including provocation tests, e.g., meal, intracolonic balloon distension, pharmacologic agents, if performed), with interpretation and report, procedure code 91117, and associated one day inpatient admission are 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 25-year-old female enrollee has requested reimbursement for calprotectin fecal laboratory testing (CPT 83993) performed on 12/24/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. | Overturned | Experimental | Summary Reviewer 3
A 25-year-old female enrollee has requested reimbursement for calprotectin fecal laboratory testing (CPT 83993) performed on 12/24/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. The physician reviewer found thant the submitted records fail to demonstrate the superior efficacy of the services at issue. Providers use the clinical history along with laboratory studies to obtain clues to ongoing inflammation related to the suspecting an underlying disorder of inflammatory bowel disease (IBD). In addition, radiographic studies and endoscopic evaluation are tools that can be used but carry their own potential risks. This patient underwent fecal calprotectin to assess the level of inflammation. An elevated fecal calprotectin is not specific for IBD. 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 calprotectin levels. Proton pump inhibitors (PPIs) have been associated with significantly elevated fecal calprotectin levels, regardless of reason for PPI. Therefore, calprotectin fecal laboratory testing (CPT 83993) performed on 12/24/20 was not likely to have been more beneficial than other available standard therapy.
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