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The patient is a 38-year-old transgender male. In a letter dated 8/23/22, the provider reported that
the patient had a diagnosis of gender dysphoria and recommended masculinizing body contouring
procedures. The patient has requested authorization and coverage for 15839-22 excision, excessive
skin and subcutaneous tissue (includes lipectomy), other area, and 15877 x 12 suction assisted
lipectomy, trunk. The Health Insurer has denied this request and reported that the requested service
is not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 38-year-old transgender male. In a letter dated 8/23/22, the provider reported that
the patient had a diagnosis of gender dysphoria and recommended masculinizing body contouring
procedures. The patient has requested authorization and coverage for 15839-22 excision, excessive
skin and subcutaneous tissue (includes lipectomy), other area, and 15877 x 12 suction assisted
lipectomy, trunk. The Health Insurer has denied this request and reported that the requested service
is not medically necessary for the treatment of this patient. This denial is the subject of this appeal
and determination. The physician reviewer found that the submitted documentation supports the
medical necessity of the requested services. The World Professional Association for Transgender
Health (WPATH) notes that medically necessary gender-affirming include but are not limited to
hysterectomy with or without bilateral salpingo-oophorectomy; bilateral mastectomy, chest
reconstruction or feminizing mammoplasty, nipple resizing or placement of breast prostheses;
genital reconstruction, for example, phalloplasty and metoidioplasty, scrotoplasty, and penile and
testicular prostheses, penectomy, orchiectomy, vaginoplasty, and vulvoplasty; hair removal from
the face, body, and genital areas for gender affirmation or as part of a preoperative preparation
process; and gender-affirming facial surgery and body contouring. The WPATH further notes that
non-genital procedures are routinely performed for the treatment of gender dysphoria and that
these surgical interventions are often of greater practical significance in the patients life than
reconstruction of the genitals. Given that current medical literature supports the use of body
contouring, lipectomy, and skin removal as treatments for gender dysphoria, the requested services
are medically indicated. Therefore, 15839-22 excision, excessive skin and subcutaneous tissue
(includes lipectomy), other area, and 15877 x 12 suction assisted lipectomy, trunk are medically
necessary for the treatment of this patient.
| 1 |
A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 4/29/15. 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 3
A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 4/29/15. 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 there is a lack of support for the services at issue in this clinical setting. Some evidence exists that low serum levels of infliximab and/or the presence of antibodies to infliximab may play a role in primary or secondary response failures. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, there are few well-controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement. It has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. Thus, the superior efficacy of Prometheus Anser IFX testing performed on 4/29/15 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.
| 0 |
The parent of a four-year-old male enrollee has requested reimbursement and prospective authorization and coverage for occupational therapy services provided on 11/19/16 through 12/21/16, and 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 feeding and eating difficulties.
This patient has made progress and continues to make progress with his current occupational therapy services.
he has made further progress and the provider finds that he is at his maximum potential. | Overturned | Medical Necessity | Summary Reviewer
The parent of a four-year-old male enrollee has requested reimbursement and prospective authorization and coverage for occupational therapy services provided on 11/19/16 through 12/21/16, and 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 feeding and eating difficulties. The physician reviewer found that as noted by Manikam and Perman, the consequences of feeding disorders can be severe and treatment can include treatment of the medical condition, behavioral modification to alter the childs inappropriate learned feeding patterns, and parent education and training in appropriate parenting and feeding skills. This patient has made progress and continues to make progress with his current occupational therapy services. The patient should be able to continue occupational therapy until he has made further progress and the provider finds that he is at his maximum potential. Accordingly, the occupational therapy services provided on 11/19/16 through 12/7/16, and forward were and are medically necessary for treatment of this patients medical condition. 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.
| 1 |
A 50-year-old male enrollee has requested reimbursement for Decision-Dx Melanoma testing performed on 11/14/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 50-year-old male enrollee has requested reimbursement for Decision-Dx Melanoma testing performed on 11/14/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the National Comprehensive Cancer Network guidelines state that while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to help differentiate benign from malignant neoplasms, or to help distinguish melanomas at low-risk versus high-risk for metastasis, routine genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. This patient has an early stage melanoma. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma. This test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. Therefore, DecisionDx-Melanoma testing provided on 11/14/19 was not medically necessary for the evaluation of this patient. | 0 |
A 68-year-old female enrollee has requested reimbursement for DecisionDX Melanoma Assay provided on 2/05/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees malignant melanoma. | Upheld | Medical Necessity | Summary Reviewer
A 68-year-old female enrollee has requested reimbursement for DecisionDX Melanoma Assay provided on 2/05/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees malignant melanoma. The physician reviewer found that the staging and prognosis of cutaneous malignant melanoma is classically determined by the system spelled out by Balch. There may be some further value in adding the mitotic rate to this system. As per this system, this patient would have been staged as a T1a melanoma, with an expected 10-year survival of at least 88%. There is no information in the records submitted as to whether she had sentinel node done, nor any clinical follow-up since her diagnosis in 2011. It is also not clear why this assay was ordered in February 2016 when her initial diagnosis was in 2011. DecisionDX Melanoma Assay is a study of 31 genes in melanoma cells. It then classifies that particular melanoma as either class 1 (with a 97% disease-free rate at five years) or class 2 (with a 31% disease free-rate at five years). It is not as yet clear how DecisionDX data compares to the ten-year data of the Balch determinations, and whether it can be used to make clinical practice decisions. This is particularly in question in this patients case given her pathologic findings and excellent prognosis. All told, DecisionDX Melanoma Assay provided on 2/05/16 was not medically indicated for the treatment 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 |
patient is a 28-year-old female with a medical history including fibromyalgia, migraines and
chronic fatigue. She is requesting naltrexone HCl for the treatment of fibromyalgia and migraine
pain. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 28-year-old female with a medical history including fibromyalgia, migraines and
chronic fatigue. She is requesting naltrexone HCl for the treatment of fibromyalgia and migraine
pain. The physician reviewer found that Fibromyalgia is a chronic pain disorder with treatment
directed at reducing the major symptoms including pain, fatigue, insomnia and cognitive
dysfunction. Treatment is approached in a stepwise pattern, starting with education and
treatment of any mood or sleep disturbances. Initiation of low-dose tricyclic antidepressants or
selected antidepressants or anticonvulsants are tried when individuals do not respond to
education alone. Key aspects of treatment include an exercise program, physical therapy,
psychological interventions and multidisciplinary programs. Combination therapy is also
recommended. During flares of pain, acetaminophen, tramadol and nonsteroidal anti-
inflammatory drugs are recommended. There is limited data to support the use of naltrexone in
the treatment of fibromyalgia. Low-dose naltrexone has been associated with improved general
satisfaction with life and with improved mood but not associated with improved fatigue or
sleep. In this case, the documentation does not support that the patient has tried and failed all
recommended treatment for fibromyalgia with associated chronic fatigue. There is limited data
to support the use of low-dose naltrexone for the treatment of fibromyalgia. The data that is
available does not show an improvement in chronic fatigue, which is one of the patients
prominent symptoms. Therefore, naltrexone HCL 50 mg used to compound to the final
outcome strength of 4.5 mg provided from 6/07/21 to October 2021 was not medically
necessary for the treatment of this patient. | 1 |
A 60-year-old male enrollee has requested reimbursement for platelet-rich plasma injections performed on 3/11/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees plantar fasciitis. | Upheld | Experimental | Summary Reviewer 2
A 60-year-old male enrollee has requested reimbursement for platelet-rich plasma injections performed on 3/11/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees plantar fasciitis. The physician reviewer found that the medical evidence has not established the superior efficacy of services at issue. Most of the studies on the use of platelet-rich plasma therapy for plantar fasciitis advise of some efficacy. However, the reviewers often note that further investigation is necessary to fully understand this treatment and its full potential. There is a lack of large, double blind, placebo-controlled studies for this treatment modality. Currently, the minimally invasive endoscopic plantar fasciotomy demonstrates a 90% cure rate. Physical therapy including ultrasound, stretching of plantar fascia, off-loading of pressure to the plantar fascia with casting, local steroid injections to the origin of the plantar fascia, and orthotics all demonstrate a high cure rate for plantar fasciitis. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 57-year-old female enrollee has requested authorization and coverage for duloxetine 60 mg, #60 per 30 days. The Health Insurer has denied this request indicating that the requested medication quantity is not medically necessary for treatment of the enrollees fibromyalgia. | Upheld | Medical Necessity | Summary Reviewer
A 57-year-old female enrollee has requested authorization and coverage for duloxetine 60 mg, #60 per 30 days. The Health Insurer has denied this request indicating that the requested medication quantity is not medically necessary for treatment of the enrollees fibromyalgia. The physician reviewer found that a review of the literature reveals that there is a lack of evidence that doses greater than 60 mg per day of duloxetine confer additional benefit for fibromyalgia patients, even in patients who do not respond to a 60 mg dose. In addition, higher duloxetine doses are associated with a higher rate of adverse reactions. Further, the documentation does not reveal that the patients history, symptoms, and examination findings are consistent with a diagnosis of fibromyalgia. Moreover, the documentation does not reveal that the patient has had significant objective functional improvement or a significant objective improvement in pain on duloxetine. For these reasons the documentation does not support the medical necessity of duloxetine 60 mg, #60 per 30 days for treatment of this patients medical condition. Based on the foregoing discussion, the requested medication quantity 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 reimbursement for laboratory testing (CPT code 84999) provided on 9/4/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis.
the records indicate that this patient has ulcerative colitis that has remained severe despite treatment with azathioprine and Humira. An Ans
as the disease is advanced and the patient had already failed several regimens. | Upheld | Experimental | Summary Reviewer 3
A 66-year-old female enrollee has requested reimbursement for laboratory testing (CPT code 84999) provided on 9/4/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found that the records indicate that this patient has ulcerative colitis that has remained severe despite treatment with azathioprine and Humira. An Anser ADA test was performed to help determine the patients course of treatment. Determining a patients Humira levels has become important when a patient loses response to Humira, which may require increasing the dose. In this case, there is concern as the disease is advanced and the patient had already failed several regimens. Determining whether the patient has therapeutic levels and antibodies may point the treating provider toward a different drug or another etiology. Moreover, it has been shown that checking for these antibodies helps optimize clinical response by helping achieve a more optimal drug concentration (Baert, et al; Vande Casteele, et al). 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 51-year-old female enrollee has requested reimbursement for mental health residential treatment from 5/13/15 through 6/07/15. The Health Plan has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees alcohol use disorder.
In this case, the patients alcohol use disorder was complicated by co-occurring mood and anxiety disorders. He alcohol use dominated her daily routine and generated distress. Further, her drinking | Overturned | Medical Necessity | Summary Reviewer
A 51-year-old female enrollee has requested reimbursement for mental health residential treatment from 5/13/15 through 6/07/15. The Health Plan has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees alcohol use disorder. The physician reviewer found the submitted documentation supports the medical necessity of the services at issue. In this case, the patients alcohol use disorder was complicated by co-occurring mood and anxiety disorders. He alcohol use dominated her daily routine and generated distress. Further, her drinking negatively impacted her health, strained meaningful relationships, and caused significant impairment across multiple domains of functionality. Additionally, her motivation and social supports were limited. In this patients case, the residential treatment provided was safe, appropriate and consistent with good practice. Additionally, the services provided during the disputed timeframe were for active treatment, and reasonably expected to improve her condition and prevent a more serious episode of illness. Further, the duration of the disputed treatment course was within community practice standards. All told, mental health residential treatment provided from 5/13/15 through 6/07/15 was medically indicated for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 46-year-old male enrollee has requested authorization and coverage for Repatha. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hyperlipidemia.
The records note a history of hyperlipidemia, intolerance to statin medications and Zetia, but no documented cardiovascular disease. | Upheld | Medical Necessity | Summary Reviewer
A 46-year-old male enrollee has requested authorization and coverage for Repatha. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hyperlipidemia. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. The records note a history of hyperlipidemia, intolerance to statin medications and Zetia, but no documented cardiovascular disease. Repatha (evolocumab) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor studied only in patients with heterozygous familial hypercholesterolemia or for patients with documented atherosclerotic heart disease who require additional lowering of LDL cholesterol. This patient does not fit either of those categories. There is no documentation to support a history of homozygous familial hypercholesterolemia or heterozygous hypercholesterolemia. These diagnoses require not only elevated LDL levels that significantly exceed 180 mg/dL, but also a combination of physical examination findings (arcus cornealis below the age of 45, tendon xanthomata), a strong family history of coronary disease (younger than 50 years in second-degree relative or younger than 55 years in first-degree relatives) and documented genetic defects related to cholesterol metabolism. PCSK9 inhibitors have not been studied in other patient populations, such as this patient. Current guidelines that are endorsed by several national organizations do not recommend the use of PCSK9 inhibitors in this primary prevention setting. Thus, Repatha is not medically necessary for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
An 18-year-old male enrollee has requested reimbursement for residential treatment services from 8/04/15 through 12/10/15. The Health Insurer has denied this request indicating that the not medically necessary for treatment of the enrollees behavioral health conditions.
Based upon the records, this patient was able to engage in therapy. The patient was able to confront various issues with his family and had the ability to express emotion with less depression. The patient did not appear to be a safety risk according to the records and was not showing any impairment of reality, including command hallucinations, agitation | Upheld | Medical Necessity | Summary Reviewer
An 18-year-old male enrollee has requested reimbursement for residential treatment services from 8/04/15 through 12/10/15. The Health Insurer has denied this request indicating that the not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. Based upon the records, this patient was able to engage in therapy. The patient was able to confront various issues with his family and had the ability to express emotion with less depression. The patient did not appear to be a safety risk according to the records and was not showing any impairment of reality, including command hallucinations, agitation or aggression or withdrawal. The medical evidence does not support continued treatment at the residential treatment facility in this clinical setting. Per the records, the patient could have been safely and effectively treated in a less restrictive setting. In sum, residential treatment services from 8/04/15 through 12/10/15 were not medically indicated for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 41-year-old male enrollee has requested authorization and coverage for CPT 43284 (laparoscopy, surgical, esophageal sphincter augmentation procedure). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
This patient has gastroesophageal reflux as based on pH recording. However, it appears he has benefited substantially from pantoprazole, and symptoms of gastroesophageal reflux disease recur when he discontinues this drug. | Upheld | Experimental | Summary Reviewer 1
A 41-year-old male enrollee has requested authorization and coverage for CPT 43284 (laparoscopy, surgical, esophageal sphincter augmentation procedure). 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 submitted documentation fails to demonstrate the superior efficacy of the requested services. The U.S. Food and Drug Administration has approved the LINX device for patients with diagnosed gastroesophageal reflux disease as defined by abnormal pH testing, and who continue to have chronic gastroesophageal reflux disease symptoms despite maximal medical therapy for the treatment of reflux. This patient has gastroesophageal reflux as based on pH recording. However, it appears he has benefited substantially from pantoprazole, and symptoms of gastroesophageal reflux disease recur when he discontinues this drug. As such, he cannot be considered refractory to medical management. Given this patients excellent response and tolerance to conventional acid suppression medication and the attendant surgical risks of LINX implantation, the requested CPT 43284 (laparoscopy, surgical, esophageal sphincter augmentation procedure) is not likely to be more beneficial than other available treatment options.
| 1 |
A 63-year-old female enrollee has requested reimbursement for Guardant360 testing
performed on 2/04/21. The Health Insurer has denied this request and reported that the
services at issue were investigational for the evaluation of the enrollees medical condition.
that this patient had lymphadenopathy that was suspicious for breast
cancer recurrence.
Instead, the patient had a peripheral blood analysis of oncogenic
mutations. | Upheld | Experimental | Summary Reviewer 2
A 63-year-old female enrollee has requested reimbursement for Guardant360 testing
performed on 2/04/21. The Health Insurer has denied this request and reported that the
services at issue were investigational for the evaluation of the enrollees medical condition. The
physician reviewer found that this patient had lymphadenopathy that was suspicious for breast
cancer recurrence. The priority should have been resection or biopsy of the lymph node
followed by mutation analysis. Instead, the patient had a peripheral blood analysis of oncogenic
mutations. Guardant360 testing cannot be used to diagnose metastatic disease. The
Guardant360 test is a liquid biopsy that analyzes patient plasma for mutations in a panel of 70
genes. Von Hoff and colleagues performed a clinical study directly compared the use of
targeted agents with conventional chemotherapy approaches. The study involved 86 patients,
and the progression-free survival on regimen selected by molecular profiling was compared to
the progression-free survival on the last chemotherapy regimen. The regimen selected by
molecular profiling offered a 27% survival advantage. This trial has very significant results for
patients with stage IV tumors. Under normal circumstances with the diagnosis of metastatic
disease, a comprehensive mutational analysis is indicated to better hone therapeutic options.
However, in this case, the test was being used for diagnostic purposes, to diagnose the
presence of stage four disease. There is a lack of support for the services at issue in this setting.
Therefore, Guardant360 testing performed on 2/04/21 was not likely to have been more
beneficial than any available standard therapy.
| 1 |
The patient is a 62-year-old male who presented to his provider on 4/16/21. The records noted recurrent and progressive low back pain, bilateral hip pain and leg pain associated with spinal stenosis. The patient has requested reimbursement for epidural injections performed on 5/05/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 62-year-old male who presented to his provider on 4/16/21. The records noted recurrent and progressive low back pain, bilateral hip pain and leg pain associated with spinal stenosis. The patient has requested reimbursement for epidural injections performed on 5/05/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that with regard to the request for lumbar epidural steroid injections, there is medical evidence supporting this treatment modality in specific patients. Hooten and Cohen noted, aIn patients with radicular pain, transforaminal epidural steroid injections may provide short-term pain relief.a Benyamin and colleagues concluded, aThe evidence based on this systematic review is good for lumbar epidural injections under fluoroscopy for radiculitis secondary to disc herniation with local anesthetic and steroids, fair with local anesthetic only; whereas it is fair for radiculitis secondary to spinal stenosis with local anesthetic and steroids, and fair for axial pain without disc herniation with local anesthetic with or without steroids.a In terms of treatment algorithms, Diwan and colleagues noted, aThe traditional treatment algorithm for lumbar spinal stenosis (LSS) consists of conservative management (physical therapy, medication, education, exercise), often followed by epidural steroid injections (ESIs), and when nonsurgical treatment has failed, open decompression surgery with or without fusion is considered.a Regarding repeat epidural steroid injections, Murthy and colleagues stated, aRepeat transforaminal epidural steroid injection (TFESI) may be performed for recurrence of radicular pain with the expectation of recovery of most or all previously achieved benefit; acute pain patients will likely recover all prior benefit. Repeat TFESIs within three months of the index injection can provide cumulative benefit.a In this case, the patient was undergoing treatment for chronic low back pain, hip pain, and leg pain and was diagnosed with lumbosacral radiculitis and spinal stenosis of the lumbar region. There is documentation that the patient previously tried physical therapy which adid provide some improvementa and the patient continued performing the exercises, but it was not sufficient to control the pain. The patient subsequently underwent epidural steroid injections performed in January 2018 and October 2019, which provided significant relief (100% pain relief, which lasted about a year each) but the pain returned. Therefore, the patient underwent a repeat epidural steroid injection on 5/05/21. The medical literature supports treatment with an epidural steroid injection after failure of conservative treatment, which includes physical therapy, medication, education, and exercise. Furthermore, repeat epidural injections are supported when there is recurrence of radicular pain. However, in this patientas case, there is a lack of documentation of recent failure of conservative treatment prior to the lumbar epidural steroid injection performed on 5/05/21. There is a lack of support for the services at issue in this setting. Therefore, epidural injections performed on 5/05/21 were not medically necessary for the treatment of this patient.
| 1 |
The parent of a 17-year-old transgender female enrollee has requested reimbursement for gender reaffirming surgery performed on 7/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gender dysphoria.
The records document a history of gender dysphoria. The Health Insurer denied reimbursement for gender affirming surgery performed on 7/26/18. The Health Insurer noted that coverage is provided for this
for patients who are 18 years of age or older, and this patient was 17 years of age at the time of surgery.
. This patient has a long history of stable transgender identity, and the experts caring for her felt that she had the maturity to make the decision to have vaginoplasty, | Overturned | Medical Necessity | Summary Reviewer
The parent of a 17-year-old transgender female enrollee has requested reimbursement for gender reaffirming surgery performed on 7/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gender dysphoria. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The records document a history of gender dysphoria. The Health Insurer denied reimbursement for gender affirming surgery performed on 7/26/18. The Health Insurer noted that coverage is provided for this procedure for patients who are 18 years of age or older, and this patient was 17 years of age at the time of surgery. World Professional Association for Transgender Health (WPATH) recommendations are flexible, taking into account the best interests of the patient. There has been considerable experience with transgender youth having vaginoplasties under age 18. In fact, it is often a better time, while the child is still living with parents, who can care for her in the perioperative period. This patient has a long history of stable transgender identity, and the experts caring for her felt that she had the maturity to make the decision to have vaginoplasty, and that it was in her best interests to have the surgery at age 17 rather than waiting until 18. Thus, gender reaffirming surgery performed on 7/26/18 was medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
The patient is a 52-year-old female who presented to her provider on 3/17/22. The patient reported
pain in her left knee that she rated at an eight out of a scale of ten. The patient has requested
reimbursement for Synvisc from 6/15/22 through 6/29/22. The Health Insurer has denied this
request and reported that the services at issue were not medically necessary.
In this case, the
patient reported pain at a level of eight out of ten that did not respond to a corticosteroid injection
on 3/17/22. The patient had tried and failed other conservative treatments. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 52-year-old female who presented to her provider on 3/17/22. The patient reported
pain in her left knee that she rated at an eight out of a scale of ten. The patient has requested
reimbursement for Synvisc from 6/15/22 through 6/29/22. The Health Insurer has denied this
request and reported that the services at issue were not medically necessary. This denial is the
subject of this appeal and determination. The physician reviewer found that the submitted
documentation supports the medical necessity of the services at issue. Per the medical literature,
although viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is
not known as to which individuals will benefit. The current evidence is limited, and guidelines
from organizations such as the American Academy of Orthopedic Surgeons indicate that the
evidence is not conclusive. In light of the foregoing, viscosupplementation can only be
recommended in individuals with a history of lasting benefit from prior injections, and in carefully
selected cases where everything else has been tried, and the options are limited. In this case, the
patient reported pain at a level of eight out of ten that did not respond to a corticosteroid injection
on 3/17/22. The patient had tried and failed other conservative treatments. Given the patients
limited options and based on the current medical literature, the services at issue were medically
indicated. Therefore, Synvisc from 6/15/22 through 6/29/22 was medically necessary for the
treatment of this patient.
| 1 |
A 50-year-old male enrollee has requested authorization and coverage for Prevymis (letermovir). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee, who is status post heart transplant.
This patient underwent a recent heart transplantation and has mild leukopenia. | Upheld | Medical Necessity | Summary Reviewer
A 50-year-old male enrollee has requested authorization and coverage for Prevymis (letermovir). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee, who is status post heart transplant. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient underwent a recent heart transplantation and has mild leukopenia. Although valganciclovir is known to be associated with leukopenia, other medications that the patient has been prescribed are also associated with leukopenia, such as Bactrim. The leukopenia present is not clearly due to valganciclovir. In addition, letermovir is approved for patients with hematopoietic stem cell transplant patients and has not been sufficiently evaluated in solid organ transplantation. Finally, bone marrow suppression also occurs using letermovir in the form of thrombocytopenia in up to 27% of patients. For these reasons, letermovir is not recommended prophylaxis for the management of cytomegalovirus in solid organ transplant recipients. Thus, Prevymis (letermovir) is not medically necessary for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 52-year-old female enrollee has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 52-year-old female enrollee has requested authorization and coverage for proton beam therapy. 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 proton therapy is well-established in dosimetric superiority and precision over photon therapy due to its Bragg peak. However, this dosimetric benefit does not always translate into a clinical benefit. An example of this lack of benefit is with prostate cancer, where proton therapy has the same rate of side effect as photon therapy. This is because the local organs at risk (bladder and rectum) have a high dose tolerance to radiation. This is not true for esophageal cancer, where the lung is very sensitive to radiotherapy. The decision on the benefit of proton radiotherapy for esophageal cancer should be made on a case-by-case basis. In this patients case, the treating provider submitted a comparison plan between photon radiotherapy and proton radiotherapy. Specifically, it was demonstrated that there was a V5 of 100% in the photon plan compared to less than 20% with the proton plan. The study by Allen and colleagues indicated that a V5 of greater than 90% is associated with a 46% rate of fatal radiation pneumonitis. Thus, proton beam therapy is likely to be more beneficial than other available treatment options.
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A 41-year-old male enrollee has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition.
In this case, the patient presents with GERD based on pH recording. His GERD has proven refractory to medical management, and thus he is expected to benefit from anti-reflux | Overturned | Experimental | Summary Reviewer 2
A 41-year-old male enrollee has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found according to Lipham and colleagues, Sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation. The LINX device is U.S. Food and Drug Administration (FDA) approved for patients diagnosed with GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximal medical therapy for the treatment of reflux. In this case, the patient presents with GERD based on pH recording. His GERD has proven refractory to medical management, and thus he is expected to benefit from anti-reflux procedures, specifically the LINX device. In addition, the patient does not have any contraindications such as large hiatal hernia, esophageal dysmotility, Barrett's esophagus or cancer. Therefore, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is a 42-year-old female who presented with a history of blood in her stool for at least six months. The patients medical history also includes nephrolithiasis. The colonoscopy note dated 10/13/17 reports finding of a 15 mm rectal polyp removed with snare cautery polypectomy, a 5 mm rectal polyp removed with a cold forceps, many small-mouthed diverticula in the sigmoid, transverse, and ascending colon, and a non-thrombosed external hemorrhoid on perianal examination. Per the patients letter, she has a family history of colon polyps. She reported that she underwent a colonoscopy and polypectomy on 10/13/17, and on 10/17/17, she had a large amount of bleeding 15-20 times, including near-syncope at 3:30 in the morning on 10/18/17. She presented to the hospital on 10/18/17. Per the emergency department note, the patients initial vital signs were normal. Per the hospital stay records, her initial hemoglobin was 11.2 g/dL, which decreased to 10.5 g/dL a few hours later. She was treated with one liter of intravenous fluids and she was discharged on 10/18/17. Per the gastroenterology consultation note dated 10/20/17, she had post-polypectomy bleeding, but did not require transfusions or sigmoidectomy. The patient has requested reimbursement for the one day acute inpatient stay provided on 10/18/17. The Health Insurer has denied this request indicating that the services at issue were | Overturned | Medical Necessity | Summary Reviewer
The patient is a 42-year-old female who presented with a history of blood in her stool for at least six months. The patients medical history also includes nephrolithiasis. The colonoscopy note dated 10/13/17 reports finding of a 15 mm rectal polyp removed with snare cautery polypectomy, a 5 mm rectal polyp removed with a cold forceps, many small-mouthed diverticula in the sigmoid, transverse, and ascending colon, and a non-thrombosed external hemorrhoid on perianal examination. Per the patients letter, she has a family history of colon polyps. She reported that she underwent a colonoscopy and polypectomy on 10/13/17, and on 10/17/17, she had a large amount of bleeding 15-20 times, including near-syncope at 3:30 in the morning on 10/18/17. She presented to the hospital on 10/18/17. Per the emergency department note, the patients initial vital signs were normal. Per the hospital stay records, her initial hemoglobin was 11.2 g/dL, which decreased to 10.5 g/dL a few hours later. She was treated with one liter of intravenous fluids and she was discharged on 10/18/17. Per the gastroenterology consultation note dated 10/20/17, she had post-polypectomy bleeding, but did not require transfusions or sigmoidectomy. The patient has requested reimbursement for the one day acute inpatient stay provided on 10/18/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary. In this case, the patient presented with a significant amount of bleeding following colonoscopy and polypectomy and marked anemia. Bleeding after snare cautery polypectomy can be severe, and therefore requires close monitoring. This condition may also require urgent intervention, including surgical or angiographic intervention when severe (Pasha, et al; Kim, et al; Jang, et al). Although the intensive care unit level of care was not needed given the patients normal vital signs, the inpatient level of care was appropriate given the rapidity of the bleeding and decline in hemoglobin. For these reasons, the one day acute inpatient stay provided on 10/18/17 was medically necessary for the treatment of this patients hematochezia. 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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The parent of a 14-year-old male enrollee has requested authorization and coverage for Nutropin AQ Nuspin 10 mg/2mL (5 mg/mL) subcutaneous pen injector. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
This patient has had a gradual decline in his growth velocity, as shown on the growth chart. His current height is -2.98 standard deviations below the mean for age and sex.
. Per the records, his estimated adult height prediction gradually deteriorated over time on serial bone age studies, which indicates abnormal growth. The patient is
. His estimated adult height is significantly below his mid-parental target height. His height deteriorated despite improvement of his weight, | Overturned | Medical Necessity | Summary Reviewer
The parent of a 14-year-old male enrollee has requested authorization and coverage for Nutropin AQ Nuspin 10 mg/2mL (5 mg/mL) subcutaneous pen injector. 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 thaat the submitted documentation supports the medical necessity of the requested medication. This patient has had a gradual decline in his growth velocity, as shown on the growth chart. His current height is -2.98 standard deviations below the mean for age and sex. This is severe short stature. The Pediatric Endocrine Society supports the use of growth hormone for the treatment of short stature that is below -2.25 standard deviations. Thus, this patient has severe short stature that meets this criterion for treatment. Per the records, his estimated adult height prediction gradually deteriorated over time on serial bone age studies, which indicates abnormal growth. The patient is not likely to meet his genetic potential with such a poor growth velocity. His estimated adult height is significantly below his mid-parental target height. His height deteriorated despite improvement of his weight, which indicates abnormal growth beyond what can be explained by poor nutrition. Therefore, Nutropin AQ Nuspin 10 mg/2mL (5 mg/mL) subcutaneous pen injector is medically necessary for the treatment of this patient. | 1 |
A 52-year-old male enrollee has requested authorization and coverage for Entyvio (J3490). 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 52-year-old male enrollee has requested authorization and coverage for Entyvio (J3490). 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 Entyvio (vedolizumab) is a humanized monoclonal antibody that targets a protein called alpha-4-beta-7, an integrin on inflammatory cells that causes these cells to adhere to the gastrointestinal tract. Entyvio is specifically indicated for adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroid. Entyvio is indicated to induce and maintain clinical response/clinical remission, achieve corticosteroid-free remission and improve the endoscopic appearance of the mucosa (UC). In a meta-analysis of biologic agents, which included vedolizumab and the TNF-inhibitors infliximab, adalimumab, and golimumab, there was no conclusive evidence that any one was more effective than any other in maintaining clinical remission in patients with moderate to severe ulcerative colitis (Danese, et al). In this case, the clinical records neither evidence a severely active flare of ulcerative colitis, nor treatment failure to conventional agents, for which vedolizumab is U.S. Food and Drug Administration (FDA) indicated. In this clinical setting, based on provided documentation Entyvio is not medically necessary for treatment of the patients medical condition. Based upon the information set forth above, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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patient is a 40-year-old female with a history of breast cancer. On 7/01/19, she underwent a bilateral mastectomy with bilateral deep inferior epigastric perforator (DIEP) flap reconstruction. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 40-year-old female with a history of breast cancer. On 7/01/19, she underwent a bilateral mastectomy with bilateral deep inferior epigastric perforator (DIEP) flap reconstruction. The physician reviewer found that the DIEP flap was for breast reconstruction and was medically necessary. However, the service in dispute in this case is code 15734. Code 15734 describes muscle, myocutaneous, or fasciocutaneous flap, trunk. This code is used in the setting of ventral hernia repair or for repair of wide diastasis recti. The medical records do not support this code in this patientas case. Based on the submitted medical records, there was no ventral hernia repair or repair of wide diastasis recti reported. Per the submitted records, no abdominal weakness or hernia was reported as being present to require a separation of parts repair. Therefore, 15734-59-62 and 15734-62 performed on 7/01/19 were not medically necessary for the treatment of this patient.
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A 59-year-old female enrollee has requested reimbursement for A0431 ambulance service - conventional air services - transport one way provided on 12/1/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees sore throat and fever.
. In this case, the patient presented with pneumonia status post lung transplant requiring anti-rejection immunosuppressive medications. The patient was at elevated risk for developing a rejection of her transplanted lungs and it was critical that she be treated in a facility capable of managing such complications.
patient, who was tachypneic, had a central venous access and required supplemental oxygen. | Overturned | Medical Necessity | Summary Reviewer
A 59-year-old female enrollee has requested reimbursement for A0431 ambulance service - conventional air services - transport one way provided on 12/1/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees sore throat and fever. The physician reviewer found that air ambulance services are supported as medically necessary when a patient meets specific criteria. These circumstances include when the point of pickup is inaccessible by land or there is a great distance or obstacle involved in land transport. Another circumstance is when the time needed to transport the patient by land poses a threat to a patients survival or the proper equipment needed for the patient is not available on a land ambulance. A patient might also require air ambulance services in order to be transferred from one facility to another in order to receive specialized services. In such a case, the patient must be transferred to the closest facility capable of providing the specialty services. In this case, the patient presented with pneumonia status post lung transplant requiring anti-rejection immunosuppressive medications. The patient was at elevated risk for developing a rejection of her transplanted lungs and it was critical that she be treated in a facility capable of managing such complications. CMC did not have the specialty services to provide inpatient care for this patient and the documentation suggests that CUH was the closest facility capable of providing the appropriate level of care. The time necessary to transport the patient by ground ambulance would have been at least six hours, which would have posed a danger to this patient, who was tachypneic, had a central venous access and required supplemental oxygen. Given these findings, the A0431 ambulance service - conventional air services - transport one way provided on 12/1/17 were medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
The patient is a 48-year-old female who presented for a colonoscopy on 12/29/21. The patient
has requested reimbursement for monitored anesthesia care provided during colonoscopy on
12/29/21. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 48-year-old female who presented for a colonoscopy on 12/29/21. The patient
has requested reimbursement for monitored anesthesia care provided during colonoscopy on
12/29/21. The physician reviewer found that according to the American Society of
Anesthesiologists guideline 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 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 moderate sedation), 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. None of these conditions are documented. The submitted documentation fails to
demonstrate the medical necessity of the services at issue. Therefore, monitored anesthesia care
provided during colonoscopy on 12/29/21 was not medically necessary for the treatment of this
patient. | 1 |
A 21-year-old female enrollee has requested reimbursement and prospective authorization and coverage for partial hospitalization level of care provided from 9/29/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. | Upheld | Medical Necessity | Summary Reviewer
A 21-year-old female enrollee has requested reimbursement and prospective authorization and coverage for partial hospitalization level of care provided from 9/29/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the episodic placement at higher levels of care is often necessary, modern psychiatric practice aims to place patients in the least restrictive treatment setting to optimize treatment gains and foster autonomous resilience. Although the patient has likely benefitted from the disputed service, the record does not support the medical necessity of partial hospitalization programming at this time. Upon presentation, the patient was at a healthy weight. Her body mass index was within normal limits. Her electrocardiogram was normal sinus rhythm. Her blood pressure was normal as was her heart rate, except upon measurement in the supine position which routinely thereafter returned mildly bradycardic in the mid-50s. The patient did have a normal glucose initially followed by hypoglycemic readings in late September. It does not appear that the blood sugar was re-tested until early November at which time it was within normal limits. According to the psychosocial assessment, the patient was described as eloquent, intelligent, motivated with a supportive family. On 9/10/15, the patient was started on a serotonergic enhancing medication for her mood and anxiety. On 9/23/15, the patient had a normal bone scan. On 9/24/15, the patients weight was stable. She completed 100% of her meals and snacks. She reported single episodes of purging on 9/22/15 and 9/23/15. During her therapy session that day, she named her eating disorder and expressed re-invigorated motivation to get back on track. The therapist noted that the patient was becoming more insightful regarding her eating disorder. On 9/26/15, the patient was calm, social and comfortable at meal time. She ate 100% of her meals at a steady pace with minimal supervision. On 9/27/15, the patient had a successful dinner with her parents. On 9/28/15, the patient was active in programming and demonstrated no eating disordered behavior. The record did not describe any medical issues or psychiatric distress.
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The patient is a 64-year-old female. Notes dated 9/12/22 reported that the patient had eosinophilic
esophagitis, complicated by stricture, status post dilation, resulting in esophageal perforation
requiring esophagectomy. The patient has requested authorization and coverage for a Botox
(onabotulinum toxin A) injection. The Health Insurer has denied this request and reported that the
requested services is not medically necessary for the treatment of this patient.
In this case, the patient had an esophageal resection and subsequent development of
pyloric stenosis. The records noted past successful improvement with an EGD with Botox. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 64-year-old female. Notes dated 9/12/22 reported that the patient had eosinophilic
esophagitis, complicated by stricture, status post dilation, resulting in esophageal perforation
requiring esophagectomy. The patient has requested authorization and coverage for a Botox
(onabotulinum toxin A) injection. The Health Insurer has denied this request and reported that the
requested services is not medically necessary for the treatment of this patient. This denial is the
subject of this appeal and determination. The physician reviewer found that the submitted
documentation supports the medical necessity of the requested service. Fuchs and colleagues
report that intraoperative endoscopic injection of botulinum toxin into the pylorus during robotic-
assisted transhiatal esophagectomy is feasible, safe, and effective and can prevent the need for
pyloromyotomy. Bagheri and colleagues note that given the need to use less-aggressive techniques
and facilitate greater use of endoscopic methods, botulinum toxin injection may be used instead of
pyloroplasty as a simple, effective, and complication-free method to prevent delayed gastric
emptying. In this case, the patient had an esophageal resection and subsequent development of
pyloric stenosis. The records noted past successful improvement with an EGD with Botox. Given
that current medical literature supports the use of chemical pyloromyotomy with Botox as safe and
effective, the requested service is medically indicated. Therefore, a Botox (onabotulinum toxin A)
injection is medically necessary for the treatment of this patient.
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A 43-year-old male enrollee has requested authorization and coverage for thermal destruction
of intraosseous basivertebral nerve first two bodies, lumbar or sacral. The Health Insurer has
denied this request and reported that the requested services are investigational for the
treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 43-year-old male enrollee has requested authorization and coverage for thermal destruction
of intraosseous basivertebral nerve first two bodies, lumbar or sacral. 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 current medical
literature supports the use of the requested procedure in leading to statistically significant
improvement over continuation of standard treatment. Fischgrund and colleagues report that
patients treated with radiofrequency ablation of the basivertebral nerve for the treatment of
chronic back pain maintained benefits at two years following treatment in both Oswestry
Disability Index (ODI) and Visual Analog Scale (VAS). The requested procedure is more effective
than continued conservative care particularly in the setting of Modic endplate changes as seen
on this patients MRI. Therefore, thermal destruction of intraosseous basivertebral nerve first
two bodies, lumbar or sacral is likely to be more beneficial for treatment of the patients
condition than any available standard therapy.
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The patient is a 59-year-old male who sustained left ear trauma while riding his bicycle. The patient has requested reimbursement for otoplasty performed on 10/14/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
photographs document left facial trauma. Post-acute photographs show a missing left earlobe, and photographs post repair show a natural looking earlobe on the left side. No other ear deformity is seen. Per the records, the patient underwent reconstruction of a partially avulsed left earlobe with release of the left ear scar contracture, adjacent tissue transfer, and full thickness skin graft. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 59-year-old male who sustained left ear trauma while riding his bicycle. The patient has requested reimbursement for otoplasty performed on 10/14/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that the submitted photographs document left facial trauma. Post-acute photographs show a missing left earlobe, and photographs post repair show a natural looking earlobe on the left side. No other ear deformity is seen. Per the records, the patient underwent reconstruction of a partially avulsed left earlobe with release of the left ear scar contracture, adjacent tissue transfer, and full thickness skin graft. Hendricks and colleagues stated, aProminent ears are by far the most common congenital ear deformity. Many techniques have been described using one or a combination of three basic methods: cartilage cutting, cartilage weakening and pure cartilage shaping techniques. The ideal otoplasty technique should yield a natural correction of the deformity, with low recurrence rates and with little risk of complications.a Otoplasty is considered in the medical literature to refer to correction of a variety of causes of prominent ears. In this patientas case, there was no report of prominent pinna or corrected deformity of the pinna in the medical information received for review. Therefore, the otoplasty performed on 10/14/19 was not medically necessary for the treatment of this patient.
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A 43-year-old male enrollee has requested reimbursement for the left eye corneal collagen cross-linking provided on 7/21/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees progressive keratoconus. | Overturned | Experimental | Summary Reviewer 2
A 43-year-old male enrollee has requested reimbursement for the left eye corneal collagen cross-linking provided on 7/21/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees progressive keratoconus. The physician reviewer found that treatment for this patients left eye with corneal collagen cross-linking provided on 7/21/16 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based on the patients vision loss and stage of keratoconus, the cross-linking was the most appropriate and effective treatment available. Overall, collagen cross-linking has been shown to be a safe and effective procedure for stabilizing corneal ectasia and potentially delaying or preventing the need for full-thickness corneal transplant. For these reasons, the left eye corneal collagen cross-linking provided on 7/21/16 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of an eight-year-old male enrollee has requested authorization and coverage for Omnitrope (somatropin) 100 mg cartridge, 0.8 mg per day. 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
The parent of an eight-year-old male enrollee has requested authorization and coverage for Omnitrope (somatropin) 100 mg cartridge, 0.8 mg per day. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested medication in this clinical setting. This patient does not have a known hypothalamic-pituitary defect or a known deficiency of at least one pituitary hormone (other than growth hormone), which would allow the diagnosis of growth hormone deficiency without growth hormone stimulation testing. In addition, this patient does not have a medical condition for which growth hormone is strongly recommended, such as chronic renal insufficiency, IGF-1 deficiency or Prader-Willi syndrome. Although increasing numbers of patients with Noonan syndrome are receiving growth hormone therapy, this patient does not meet the diagnostic criteria for Noonan syndrome and has not seen a geneticist to confirm the diagnosis. Based on this patients normal laboratory results and delayed bone age, the most likely diagnoses are idiopathic short stature, constitutional delay and familial short stature (or a combination of these). The 2008 consensus guidelines on idiopathic short stature are most relevant and includes no clear biochemical criteria for initiating growth hormone therapy and no requirement for growth hormone stimulation testing. This patients consistently low height standard deviation and predicted final adult height support the use of recombinant growth hormone therapy in this case. Therefore, Omnitrope (somatropin) 100 mg cartridge, 0.8 mg per day is medically necessary for the treatment of this patient. | 1 |
A 30-year-old female enrollee has requested reimbursement for air ambulance transportation provided on 12/20/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who has a history of spinal muscular atrophy.
that this patient has a diagnosis of spinal muscular atrophy. She had acute respiratory failure on 11/16/17, necessitating admission to Cottage Health Hospital. During the course of her admission, the patients family made inquiries regarding transferring the patient to a facility with more expertise in treating patients with spinal muscular atrophy. By 12/19/17, the patient had been weaned from a ventilator to a tracheostomy collar. The patients family requested the patient be transferred to Rutgers University Hospital to the care of a specialist in spinal muscular atrophy where studies had been conducted to determine appropriate respiratory protocol and management strategies. However, the records
this patient required emergent air ambulance transportation. The patient was hemodynamically stable. She had already been weaned to a tracheostomy collar. Although the provider at Rutgers University Hospital had conducted research with spinal muscular atrophy | Upheld | Medical Necessity | Summary Reviewer
A 30-year-old female enrollee has requested reimbursement for air ambulance transportation provided on 12/20/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who has a history of spinal muscular atrophy. The physician reviewer found that this patient has a diagnosis of spinal muscular atrophy. She had acute respiratory failure on 11/16/17, necessitating admission to Cottage Health Hospital. During the course of her admission, the patients family made inquiries regarding transferring the patient to a facility with more expertise in treating patients with spinal muscular atrophy. By 12/19/17, the patient had been weaned from a ventilator to a tracheostomy collar. The patients family requested the patient be transferred to Rutgers University Hospital to the care of a specialist in spinal muscular atrophy where studies had been conducted to determine appropriate respiratory protocol and management strategies. However, the records do not demonstrate that this patient required emergent air ambulance transportation. The patient was hemodynamically stable. She had already been weaned to a tracheostomy collar. Although the provider at Rutgers University Hospital had conducted research with spinal muscular atrophy patients, there is a lack of evidence to support that this patient required a higher level of care at the time of her transfer. It appears the transfer was initiated at the request of the patients family. The documentation submitted does not support that this patient required emergent air ambulance transportation to receive medically necessary higher level of care at the closest hospital capable of providing such services. Thus, air ambulance transportation provided on 12/20/17 was not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 63-year-old female enrollee has requested authorization and coverage for Forteo. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees osteoporosis.
this patient has severe osteoporosis and multiple gastrointestinal issues.
dental issues or plans for major dental work. She is reported to have small bowel dysmotility, celiac disease, and colonic inertia and unable to take oral bisphosphonates. | Upheld | Medical Necessity | Summary Reviewer
A 63-year-old female enrollee has requested authorization and coverage for Forteo. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees osteoporosis. The physician reviewer found that this patient has severe osteoporosis and multiple gastrointestinal issues. However, the medical records fail to demonstrate evidence of kidney disease or any pending dental issues or plans for major dental work. She is reported to have small bowel dysmotility, celiac disease, and colonic inertia and unable to take oral bisphosphonates. There is no history of contraindication to bisphosphonates or chronic kidney disease. Given her history, the current guidelines would recommend intravenous bisphosphonates (zoledronic acid) as the preferred agent for this patient. Reclast or zoledronic acid is preferred if oral bisphosphonates cannot be tolerated. Prolia is a recommended alternative in this patients case. Reclast would be would be an option in this case given her normal renal function, Candidates for teriparatide include those with severe osteoporosis and are at high risk for fracture (T-score of -3.5 or below without fractures; T-score of -2.5 or below plus a fragility fracture), those who cannot tolerate bisphosphonates or who have relative contraindications to oral bisphosphonates (achalasia, scleroderma esophagus, esophageal strictures) and those who have failed other osteoporosis therapies. In this patients case, she does have evidence of severe osteoporosis and has reported that she cannot take oral bisphosphonates. However, the records do not show that she has tried other therapies like Reclast or Prolia. As such, Forteo is not medically necessary for treatment of this patient. The Health Insurers denial should be upheld. Therefore, for the reasons stated above, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 57-year-old male enrollee has requested reimbursement for electromagnetic navigational bronchoscopy performed on 9/29/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung nodule. | Overturned | Experimental | Summary Reviewer 2
A 57-year-old male enrollee has requested reimbursement for electromagnetic navigational bronchoscopy performed on 9/29/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung nodule. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. Electromagnetic navigational bronchoscopy is a unique tool that allows the provider to accurately guide bronchoscopic tools to predetermined points within the tracheobronchial tree. With this system, the provider can accurately guide the steerable extended working channel to a suspicious peripheral lesion for diagnostic testing. The alternatives to electromagnetic navigational bronchoscopy biopsy include standard/blind bronchoscopy or computed tomography (CT) guided biopsies. While CT guided biopsies have a superior diagnostic yield of 90%, they are limited by complications, both pneumothoraces and hemoptysis. Electromagnetic navigational bronchoscopy has a track record of excellent diagnostic yields, low complication rates and acceptance within the medical community as a useful test of the diagnosis of a peripheral lesion. Based on the medical records, this patient was a candidate for electromagnetic navigational bronchoscopy based on the lesion size, location and shape, especially in light of his smoking history. In sum, electromagnetic navigational bronchoscopy performed on 9/29/15 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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A 59-year-old female insured has requested authorization and coverage for Rinvoq 45 mg tablets
(30 tablets every 30 days). The Health Insurer has denied this request indicating that the requested
medication is considered investigational for the treatment of the insured's Chron's disease.
The records reflect that this patient presents with a long history of Chrons disease. While the patient is medically
stable, she is | Overturned | Experimental | Summary Reviewer 3
A 59-year-old female insured has requested authorization and coverage for Rinvoq 45 mg tablets
(30 tablets every 30 days). The Health Insurer has denied this request indicating that the requested
medication is considered investigational for the treatment of the insured's Chron's disease.
The physician reviewer found that comparing Rinvoq 45 mg with placebo for patients with
moderate-to-severe Chrons disease, Rinvoq resulted in higher clinical remission rates at 12 weeks
(Loftus, et al.). Moreover, Rinvoq is FDA-approved for patients with moderate-to-severe Chrons
disease who have not responded to anti-tumor necrosis factor (TNF) therapy. The records reflect that this patient presents with a long history of Chrons disease. While the patient is medically
stable, she is not optimally treated on her current regimen, which has significantly affected her
quality-of-life. Rinvoq is FDA-approved and supported by the medical literature for the treatment
of patients with Crohn's disease. For these reasons, the requested Rinvoq 45 mg tablets (30 tablets
every 30 days) are likely to be more beneficial for the treatment of the patients condition than any
available standard therapy.
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patient is a 52-year-old male with asthma. The patient has requested authorization and coverage for Nucala auto injector pen. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 52-year-old male with asthma. The patient has requested authorization and coverage for Nucala auto injector pen. The physician reviewer found that Nucala is U.S. Food and Drug Administration (FDA) approved and supported by the medical evidence for the management of severe asthma in adults with an eosinophilic phenotype of asthma. Based on the available information, it is fair to characterize the phenotype of the patientas asthma as eosinophilic, based on an elevated peripheral eosinophil count of 180. It is important to note that peripheral eosinophils were elevated while the patient was taking systemic steroids, which is quite remarkable, as steroids typically drive down eosinophils. This information demonstrates that an eosinophilic process was at play. There is sufficient support for the requested medication in this clinical setting. Therefore, Nucala auto injector pen is medically necessary for the treatment of this patient. | 1 |
A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
percutaneously in the interspinous space with minimal disruption of the spinal anatomy.
. This patient is being treated for lumbar spinal stenosis with neurogenic claudication. | Upheld | Experimental | Summary Reviewer 2
A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that interspinous spacers were developed to avoid the risks of a traditional laminectomy via a less invasive technique that is reversible. The device is placed percutaneously in the interspinous space with minimal disruption of the spinal anatomy. The goal is to limit extension of the spine, minimizing the effects of spinal degeneration and enlarging the spinal canal and neural foramina area. This patient is being treated for lumbar spinal stenosis with neurogenic claudication. While there are many interspinous devices on the market, none have high quality research to demonstrate superiority over the current standard of care, simple decompression. The use of an interspinous spacer for spinal stenosis as a minimally invasive, stand-alone procedure has shown high failure and complication rates. Until data exists that demonstrate noninferiority of these devices to the current gold standard treatment, simple decompression, the use of the requested device as a standalone procedure should be considered investigational for the treatment of the patients condition. In sum, the requested surgical insertion of an interspinous process spacer is not likely to be more beneficial than other available standard therapy.
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A 50-year-old female enrollee has requested authorization and coverage for Balversa 4 mg
tablets (two tablets per day). The Health Insurer has denied this request indicating that the
requested medication is considered investigational for treatment of the insureds urothelial
carcinoma.
This patient has been treated with multiple lines of therapies including
EGFR targeted agents and chemotherapy. She has also been treated with liver directed therapies.
The patient was recently started on combination therapy with Tagrisso and Balversa. The
provider noted that the patient has responded well to this combination treatment reflected with
a decreasing tumor marker (CEA). | Overturned | Experimental | Summary Reviewer 2
A 50-year-old female enrollee has requested authorization and coverage for Balversa 4 mg
tablets (two tablets per day). The Health Insurer has denied this request indicating that the
requested medication is considered investigational for treatment of the insureds urothelial
carcinoma. The physician reviewer found that the use of next-generation sequencing (NGS) panel
testing as a means to select anticancer therapies in the treatment of patients with advanced
cancer has been advancing over the past few years. Once identified, a specific therapy can be
given to the patient directly treating their tumor. In this patient, NGS based molecular testing
demonstrated EGFR exon 19 mutation and FGFR2 amplification. The U.S. Food and Drug
Administration (FDA) approved Balversa for use in the setting of FGFR2/3 alteration metastatic
bladder/urothelial cancer. This patient has been treated with multiple lines of therapies including
EGFR targeted agents and chemotherapy. She has also been treated with liver directed therapies.
The patient was recently started on combination therapy with Tagrisso and Balversa. The
provider noted that the patient has responded well to this combination treatment reflected with
a decreasing tumor marker (CEA). A phase II clinical study also demonstrated the benefits of
Balversa in the treatment of patients with metastatic solid tumors with EGFR 2/3 alterations
(Loriot, et al.). As such, the requested Balversa 4 mg tablets (two tablets per day) is not likely to
be more beneficial for treatment of the patients medical condition than any available standard
therapy.
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A 52-year-old male enrollee has requested reimbursement for a wearable cardioverter defibrillator provided on 1/24/19. The Health Insurer has denied this request indicating that the device at issue was investigational for the treatment of the enrollees medical condition.
that this patient had a recent myocardial infarction and underwent acute revascularization with coronary stenting. His subsequent ejection fraction was below 35%, and his medical management was being optimized.
he was at increased risk for sudden death during this period. | Overturned | Experimental | Summary Reviewer 1
A 52-year-old male enrollee has requested reimbursement for a wearable cardioverter defibrillator provided on 1/24/19. The Health Insurer has denied this request indicating that the device at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient had a recent myocardial infarction and underwent acute revascularization with coronary stenting. His subsequent ejection fraction was below 35%, and his medical management was being optimized. In this situation, a permanent automatic implantable cardioverter-defibrillator is not indicated until three months have passed after revascularization if the ejection fraction remains less than 35%. However, he was at increased risk for sudden death during this period. Medical therapy was also being optimized to improve left ventricular function during this period. A wearable cardioverter defibrillator can provide temporary protection from early sudden death due to arrhythmia in this patient population during this interim period. The medical evidence supports the device at issue in this clinical setting. Therefore, the wearable cardioverter defibrillator provided on 1/24/19 was likely to have been more effective than other treatment options.
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A 26-year-old female enrollee has requested reimbursement for bilateral breast implant removal performed on 5/7/15. The Health Insurer has denied this request indicating that the procedure at issue was not medically necessary for treatment of the enrollees capsular contracture of breast implant. | Upheld | Medical Necessity | Summary Reviewer
A 26-year-old female enrollee has requested reimbursement for bilateral breast implant removal performed on 5/7/15. The Health Insurer has denied this request indicating that the procedure at issue was not medically necessary for treatment of the enrollees capsular contracture of breast implant. The physician reviewer found the review of the submitted documentation and relevant literature fails to demonstrate the medical necessity for the procedure at issue. According to Handel and colleagues It has become increasingly apparent in recent years that breast implant recipients experience a significant incidence of complications and a relatively high rate of reoperation. In large-scale follow-up studies conducted by manufacturers, it was reported that by the end of 5 years, women undergoing augmentation with saline-filled implants had a 10 percent rate of significant (Baker grade 3 or 4) contracture. In this case, the patient underwent SERI implant removal. However, the documentation submitted for review fails to demonstrate the patient had a current infection, seroma or other functional problem that would necessitate implant removal. In addition, the patient stated that she had severe pain, but this is not supported in the medical documentation provided for review. As such, based on the documentation submitted for review, the SERI scaffold removal was not medically necessary in this clinical setting. For the reasons provided, the bilateral breast implant removal performed on 5/7/15 was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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patient is a 42-year-old female who is requesting reimbursement for fetal chromosomal analysis via cell-free DNA. The records document advanced maternal age and history of prior miscarriages. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 42-year-old female who is requesting reimbursement for fetal chromosomal analysis via cell-free DNA. The records document advanced maternal age and history of prior miscarriages. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. Noninvasive prenatal screening by cell-free DNA is increasingly becoming accepted as an appropriate method for first trimester aneuploidy screening. Noninvasive prenatal screening is a sensitive screen for aneuploidy, is more sensitive than sequential screening, but does not require the invasive procedure of chorionic villus sampling or amniocentesis. This is the case for both younger women and for women of advanced maternal age. This test is less invasive, with less risk to the pregnancy. Therefore, fetal chromosomal microdeletions genomic sequence analysis (81422) performed on 7/09/19 was medically necessary for the evaluation of this patient. | 1 |
A 33-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) testing provided on 5/30/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of enlarged lymph nodes. | Upheld | Experimental | Summary Reviewer 1
A 33-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) testing provided on 5/30/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of enlarged lymph nodes. The physician reviewer found there is a lack of support in the medical literature for the services at issue in this clinical setting. The medical literature indicates that Epstein-Barr virus (EBV) is the main etiology of infectious mononucleosis syndrome associated with lymphadenopathy. The main methods of evaluation include PCR testing and testing by ELISA for the viral capsid antigen. Quantitative PCR testing may be indicated for the following EBV evaluations: EBV viral load, to monitor for EBV viral replication in hematopoietic stem cell and solid organ transplant recipients. More frequent testing is worth considering if the EBV load is rising. However, for standard risk individuals, as this patient, testing should be done only when they are suspected to have EBV infection. The submitted documentation does not support that this patient had a medical indication to have warranted the PCR testing. Accordingly, PCR testing provided on 5/30/17 was not likely to have been of greater benefit than the standard therapy available for evaluating this patients 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 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 2
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 there is evidence in the peer-reviewed literature from randomized trials and prospective observational trials supporting the clinical utility and impact on patient management of percutaneous tibial nerve stimulation in patients with urinary urgency and frequency. However, most trials have a small number of patients with short-term follow-up. American Urological Association (AUA) guidelines recommend that clinicians should offer behavioral therapies, such as bladder training, bladder control strategies, pelvic floor muscle training and fluid management, as first-line therapy to all patients with overactive bladder. Behavioral therapies may be combined with pharmacologic management. Clinicians should offer oral antimuscarinics or oral 3-adrenoceptor agonists as second-line therapy. If a patient experiences inadequate symptom control and/or unacceptable adverse drug events with one anti-muscarinic medication, then a dose modification or a different anti-muscarinic medication or a 3-adrenoceptor agonist may be tried. Patients who are refractory to behavioral and pharmacologic therapy should be evaluated by an appropriate specialist if they desire additional therapy. The guidelines rate percutaneous tibial nerve stimulation as a third-line therapy. Botox injection is a standard third-line therapy which is graded better. The use of percutaneous tibial nerve stimulation has not been proven to be superior to other alternatives. In this case, the records do not document that the patient had a complete trial and failure of first-line and second-line therapy. The documentation does not support prior failure of behavior modification. She was prescribed low dose Toviaz, the response to which is unknown. The first intervention would be dose escalation if she had no response to low dose Toviaz. In sum, percutaneous tibial nerve stimulation performed from 5/08/18 through 8/02/18 was not likely to have been superior over other 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 26-year-old male enrollee has requested reimbursement for cervical discography injection provided on 6/25/20. The Health Insurer indicates that the services at issue were investigational for the treatment of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue.
In this case, the patient has been treated for cervical pain. There is a history of cervical spine fusion in March 2019. The patient developed worsening neck pain for which he has undergone extensive conservative pain management, with no clinical response. He demonstrated high cervical mechanical pain characteristics unassociated with any significant referral or radiation. Examination revealed no high cervical | Upheld | Experimental | Summary Reviewer 1
A 26-year-old male enrollee has requested reimbursement for cervical discography injection provided on 6/25/20. The Health Insurer indicates that the services at issue were investigational for the treatment of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. Additional records were reviewed, and these records fail to demonstrate the superior efficacy of the services at issue. Manchikanti and colleagues concluded that lumbar provocation discography performed according to the International Association for the Study of Pain (IASP) criteria may be a useful tool for evaluating chronic lumbar discogenic pain. The evidence is weaker for cervical and nonexistent for thoracic discography. In this case, the patient has been treated for cervical pain. There is a history of cervical spine fusion in March 2019. The patient developed worsening neck pain for which he has undergone extensive conservative pain management, with no clinical response. He demonstrated high cervical mechanical pain characteristics unassociated with any significant referral or radiation. Examination revealed no high cervical facet clinical provocation by deep palpation. He is neurologically intact. However, there are limited large-scale, long-term references showing the safety and efficacy of this modality. There were no extenuating circumstances in this patients clinical data to support otherwise. Therefore, cervical discography injection provided on 6/25/20 was not likely to have been more beneficial than other available standard therapy.
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A 55-year-old female enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the cervical spine. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees neck pain.
This patient has had symptoms for a prolonged period of time, with no apparent relief, and now has been referred for additional cross-sectional imaging as well as to an orthopedist for consultation.
In this case, the patient has numbness and tingling extending to her fourth and fifth fingers. Her symptoms are more than just neck pain.
. This patient has already had a trial of anti-inflammatory medications. | Overturned | Medical Necessity | Summary Reviewer
A 55-year-old female enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the cervical spine. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees neck pain. The physician reviewer found the submitted records support the medical necessity of the requested services. This patient has had symptoms for a prolonged period of time, with no apparent relief, and now has been referred for additional cross-sectional imaging as well as to an orthopedist for consultation. For the first study for patients with chronic neck pain with or without a history of previous trauma, the American College of Radiology does not recommend computed tomography (CT) and states that an MRI is usually not appropriate. However, the American College of Radiology considers MRI to be the appropriate next imaging modality for patients with radiographs which show degenerative changes when neurologic signs or symptoms present. In this case, the patient has numbness and tingling extending to her fourth and fifth fingers. Her symptoms are more than just neck pain. The localization of symptoms to her fourth and fifth fingers are typical for a C8 dermatome. In this setting, MRI of the cervical spine is considered the most appropriate next imaging modality. This patient has already had a trial of anti-inflammatory medications. All told, the requested MRI of the cervical spine is medically necessary for the evaluation of this patient. Therefore, the requested services are medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 52-year-old male enrollee has requested authorization and coverage for implant stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees complex regional pain syndrome to his right foot.
The patient has severe CRPS of the right foot and has been non-responsive to a variety of interventional options including intrathecal pump and traditional spinal cord stimulation stimulator. The patients pain pattern | Upheld | Experimental | Summary Reviewer 2
A 52-year-old male enrollee has requested authorization and coverage for implant stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees complex regional pain syndrome to his right foot. The physician reviewer found that there is some support for the requested services in this patients case. The patient has severe CRPS of the right foot and has been non-responsive to a variety of interventional options including intrathecal pump and traditional spinal cord stimulation stimulator. The patients pain pattern is amenable to DRG stimulation along the lower lumbar nerve roots. DRG stimulation is proven to have long-term benefit for CRPS when other modalities have failed and is likely to be more effective than any other available standard therapy for the treatment of this patients medical condition. Therefore, for the reasons stated above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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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 3
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 there is support for the medication regimen at issue in this clinical setting. In this case, the tumor was advanced at stage IVA. Most clinical phase II clinical trials of chemotherapy regimens in cholangiocarcinoma are small since the disease is rare. There is good evidence for the initial regimen utilized here, gemcitabine/oxaliplatin, but with progression and an Eastern Cooperative Oncology Group (ECOG) performance status of 1, a second-line regimen was appropriate. FOLFIRI is a common chemotherapy regimen effectively applied in colorectal cancer but has been extended to pancreatic and gallbladder patients. FOLFIRI/bevacizumab has been examined as second-line treatment in metastatic cholangiocarcinoma patients. The addition of bevacizumab is supported by additional independent clinical data. The FOLFIRI/bevacizumab combination is safe and effective and was medically appropriate in this patient with limited treatment options. Thus, chemotherapy treatment provided from 10/06/17 through 12/13/17 was likely to have been of greater benefit than other available treatment options. Based upon the information set forth above, the medication regimen at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/31/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
This patient is a 62-year-old female who had a bilateral screening mammogram with tomosynthesis on 3/31/16. The patient reported a positive family history of breast cancer in her maternal grandmother, and in her maternal and paternal aunts. The patient presented for a breast screening examination on 3/31/16. The patients breast was noted with scattered fibroglandular densities in the right breast. The ultrasound showed small cysts. The Health Insurer has denied the tomosynthesis portion of the exam. The patient has appealed the denial and this denial is the subject of this appeal and determination.
| Overturned | Experimental | Summary Reviewer 2
A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/31/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found This patient is a 62-year-old female who had a bilateral screening mammogram with tomosynthesis on 3/31/16. The patient reported a positive family history of breast cancer in her maternal grandmother, and in her maternal and paternal aunts. The patient presented for a breast screening examination on 3/31/16. The patients breast was noted with scattered fibroglandular densities in the right breast. The ultrasound showed small cysts. The Health Insurer has denied the tomosynthesis portion of the exam. The patient has appealed the denial and this denial is the subject of this appeal and determination.
The medical literature supports breast tomosynthesis in this clinical setting. Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues state that integrated two dimensional and three dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. Thus the literature supports the use of digital breast tomosynthesis over conventional mammogram due to improved cancer detection rate. In sum, digital breast tomosynthesis performed on 3/31/16 was likely to have been superior to other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 42-year-old male enrollee has requested authorization and coverage for Tremfya. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition.
methotrexate and ustekinumab. In this case, the patient has failed prior therapy with topical medications, narrowband ultraviolet B therapy, methotrexate, Cosentyx, Taltz, Stelara, and Enbrel. He was unable to tolerate Remicade. In a letter dated 1/14/19, the provider stated that the patient requires dual therapy with Otezla and Tremfya to achieve satisfactory control of his psoriasis. | Overturned | Experimental | Summary Reviewer 2
A 42-year-old male enrollee has requested authorization and coverage for Tremfya. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the American Academy of Dermatology guidelines for the management of psoriasis recommend topical therapy as first-line treatment. If ultraviolet therapy is not available, other first-line treatments include: acitretin, adalimumab, cyclosporine, etanercept, infliximab, methotrexate and ustekinumab. In this case, the patient has failed prior therapy with topical medications, narrowband ultraviolet B therapy, methotrexate, Cosentyx, Taltz, Stelara, and Enbrel. He was unable to tolerate Remicade. In a letter dated 1/14/19, the provider stated that the patient requires dual therapy with Otezla and Tremfya to achieve satisfactory control of his psoriasis. However, the combination of Otezla and Tremfya has not been widely accepted as the standard of care in the management of refractory psoriasis. It is not yet known if the combination of Otezla and Tremfya would be safe for long-term use. In sum, Tremfya is not likely to be of greater benefit than other treatment options.
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A 27-year-old male enrollee has requested reimbursement for vitamin D testing performed on 1/15/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 27-year-old male enrollee has requested reimbursement for vitamin D testing performed on 1/15/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the clinical manifestations of vitamin D deficiency depend upon the severity and duration of the deficiency. The majority of patients with moderate to mild vitamin D deficiency are asymptomatic. With severe vitamin D deficiency, there can be hypocalcemia, which leads to bone disorders. Patient groups who are at risk for vitamin D insufficiency includes patients who are obese, those taking medications that accelerate the metabolism of vitamin D, hospitalized or institutionalized patients or individuals who have limited effective sun exposure. Other people at high risk include those with osteoporosis or malabsorption, including inflammatory bowel disease and celiac disease. Screening of the general population is not recommended. Normal-risk adults do not need assessment. In this case, the patient did not have any chronic medical conditions that would cause vitamin D deficiency. Therefore, vitamin D testing performed on 1/15/20 was not medically necessary for the evaluation of this patient. | 0 |
A 65-year-old female enrollee has requested reimbursement for collagen crosslink testing and homocysteine testing provided on 12/03/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 65-year-old female enrollee has requested reimbursement for collagen crosslink testing and homocysteine testing provided on 12/03/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. If the patient has received therapy, it would be appropriate to have a dual-energy x-ray absorptiometry (DEXA) at the end of the two-year treatment to assess the response to therapy. The value of monitoring therapy with the use of biochemical markers of bone turnover to aid in clinical decision is controversial. It is a test that can be variable and subject to timing, dietary intake as well as lack of assay standardization. Thus, collagen crosslink testing and homocysteine testing provided on 12/03/18 were not likely to have been more beneficial than other available methods of evaluating this patient.
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A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 1/03/17 and transfer of the laboratory specimen. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 1
A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 1/03/17 and transfer of the laboratory specimen. 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 DecisionDx-Melanoma testing is a 31-gene expression profile used to determine the risk of recurrence of melanomas. Per the National Comprehensive Cancer Network guidelines, routine (baseline) prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. At this time, the medical evidence has not established that the results of such genetic profiles has an independent prognostic value. The standard of care for the patient would have been wide excision and consideration of sentinel lymph node sampling, and additional follow-up could be determined by those results. All told, DecisionDx-Melanoma testing performed on 1/03/17 and transfer of the laboratory specimen was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16. 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 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16. 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 the concept of therapeutic drug monitoring of biologics in this clinical setting is not evidence-based. There is no target drug level threshold which has been established. Often, patients with a low or undetectable trough drug level are in clinical remission. Additionally, although antibodies are associated with lower drug levels and drug failure, in many patients, antibodies are transient and not of clinical significance. In sum, Anser ADA testing performed on 4/25/16 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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The patient is a 43-year-old female with right sided low back and sacroiliac pain that has failed conservative treatment. The provider has recommended a minimally invasive sacroiliac fusion using the I-Fuse implant. A review of her medical record indicates a history of chronic right sided low back and buttock pain that does not radiate down the leg. She received excellent relief from the first right sacroiliac joint injection. The magnetic resonance imaging (MRI) scan does show degenerative disc disease at L5-S1 but there is no neuro-compressive lesion. There is no clinical evidence of radiculopathy. The provider has documented failed conservative treatment including physical therapy and medications. The patient has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request on the basis that the requested services are investigational for the treatment of this patient. | Overturned | Experimental | Summary Reviewer 3
The patient is a 43-year-old female with right sided low back and sacroiliac pain that has failed conservative treatment. The provider has recommended a minimally invasive sacroiliac fusion using the I-Fuse implant. A review of her medical record indicates a history of chronic right sided low back and buttock pain that does not radiate down the leg. She received excellent relief from the first right sacroiliac joint injection. The magnetic resonance imaging (MRI) scan does show degenerative disc disease at L5-S1 but there is no neuro-compressive lesion. There is no clinical evidence of radiculopathy. The provider has documented failed conservative treatment including physical therapy and medications. The patient has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request on the basis that the requested services are investigational for the treatment of this patient. The medical evidence show that sacroiliac joint degeneration is a common cause of chronic low back pain, which is under diagnosed. Minimally invasive fusion procedures have demonstrated successful pain relief. Among these implants, the triangular titanium implants such as I-fuse have been used. Recent medical literature has documented two year follow up of these procedures demonstrating meaningful clinical improvement and maintained pain relief as well as evidence of a solid fusion on imaging studies. Cross and colleagues performed a study of patients with sacroiliac joint dysfunction who were treated with minimally invasive sacroiliac joint fusion using triangular titanium implants. The results from their study showed marked improvements in pain, disability and quality of life at two years. Imaging showed that bone apposition to implants was common but radiographic evidence of intraarticular fusion within the joint may take more than one year in many patients. This case illustrates the difficulty encountered in making an accurate diagnosis of chronic low back pain that does not respond to conservative measures. In the absence of evidence of neural compression on the MRI scan and in the presence of clinical findings of sacroiliac pain, which is relieved by injecting the sacroiliac joint, the requested procedure using the minimally invasive technique is likely to be successful in this individual. Accordingly, the request for a sacroiliac joint fusion is likely to be more effective in treating this patients low back pain than the available standard techniques. Therefore, based upon the information set forth above, the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 50-year-old female enrollee has requested reimbursement for breast tomosynthesis imaging performed on 2/10/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented for her annual breast examination. | Overturned | Experimental | Summary Reviewer 1
A 50-year-old female enrollee has requested reimbursement for breast tomosynthesis imaging performed on 2/10/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented for her annual breast examination. The physician reviewer found that there is evidence-based support for the service at issue in this clinical setting. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in callbacks and biopsies and an increase in detection of small cancers when compared to two dimensional imaging alone. Breast tomosynthesis provides advantages to radiologists interpreting mammograms. Therefore, the addition of digital breast tomosynthesis to the usual two dimensional protocol on 2/10/17 was likely to have been more effective than had her examination been performed using two dimensional imaging alone. Based upon the information set forth above, the service at issue was likely to be more beneficial for the evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 63-year-old female enrollee has requested reimbursement for an Anser ADA test performed on 5/12/15. The Health Insurer has denied this request indicating that the procedure at issue was considered investigational for evaluation of the enrollees Crohns disease with ileostomy.
. The patient had been on Humira after she had failed multiple prior regimens. | Upheld | Experimental | Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement for an Anser ADA test performed on 5/12/15. The Health Insurer has denied this request indicating that the procedure at issue was considered investigational for evaluation of the enrollees Crohns disease with ileostomy. The physician reviewer found that for this clinical setting, the Anser ADA test was likely to be more beneficial than any available standard therapy in management and treatment of the patients medical condition. The patient had been on Humira after she had failed multiple prior regimens. There could have been multiple reasons for this, each of which has a different path of management. The Anser ADA test measures the Humira blood level and detects antibodies to Humira. Patients with detectable levels and no antibodies will have to have a change in treatment management in order to control their disease, as the test implies an escape phenomenon to Humira. Patients with undetectable levels and antibodies are under-dosed and a higher dose will be needed to achieve remission and control of disease. Patients with a low level and detectable antibodies have a low drug level due to the development of antibodies. Hence, due to the multitude of management options, once a patient loses response to the biologic or has unexplained episodic symptoms that could be attributed to disease flares (such as this patient), the Anser ADA test is an effective tool for the treating provider in the management of their patients medical condition. For these reasons, the Anser ADA test performed on 5/12/15 was like to be more beneficial for evaluation of this patients medical condition than any available standard modality. In sum, the procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 20-year-old female enrollee has requested reimbursement for Anser IFX diagnostic test performed on 2/8/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees chronic ulcerative pancolitis. | Upheld | Experimental | Summary Reviewer 2
A 20-year-old female enrollee has requested reimbursement for Anser IFX diagnostic test performed on 2/8/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees chronic ulcerative pancolitis. The physician reviewer found that the use of Anser IFX test to direct management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials of patients with inflammatory bowel disease. The Prometheus Anser IFX test is a quantitative measurement of serum infliximab (IFX) and anti-IFX antibodies. Some evidence exists that low serum levels of infliximab and/or the presence of antibodies to infliximab may play a role in primary or secondary response failures. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of infliximab or the presence of IFX 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 Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. As such, 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 the study does not compare these management changes to those made in the absence of anti-drug antibody measurement (Yanai, et al). Moreover, the medical literature 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. This appears to be the case with this patient, since available records do not support a clinical presentation that raised concern for loss of drug response or for the development of drug antibodies at the time of her test. For these reasons, the Anser IFX diagnostic test administered on 2/8/16 was not likely to have been superior to the other standard therapies available for the evaluation of this patient. Based upon the information set forth above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 39-year-old male enrollee has requested reimbursement for Anser IFX testing provided on 4/23/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 39-year-old male enrollee has requested reimbursement for Anser IFX testing provided on 4/23/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the superior efficacy of the services at issue. The medical evidence has not established whether therapy guided by following trough drug levels and drug antibodies is superior to routine good clinical care. The data available are uncontrolled and come from retrospective analyses. In general, for a patient failing therapy, there is a trend toward lower trough drug levels with or without the presence of antibody. However, many patients fail therapy with a normal drug level for a variety of reasons. All told, Anser IFX testing performed on 4/23/14 was not likely to have been more effective than other methods of evaluation. 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 16-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health residential treatment from 12/07/17 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions.
. The patient had one prior suicide attempt on 4/03/17. On 12/08/17, the patient did not have any suicidal ideation. There is a concern that the patients substance use could result in an accidental overdose. With regards to functional status, the records support a score of 3. The patient had moderate functional impairment. She has conflicted relationships with her parents and peers. The patient has a history of running away from school and home. She has made modest behavioral improvements during her residential treatment center stay.
3. The patient has comorbidities of major depressive disorder, attention deficit/hyperactivity disorder, cannabis use disorder, and alcohol use disorder. The patient does not have any major medical problems which would require 24-hour monitoring. In terms of environmental stress, the records
The patients father would like to be involved in the patients care, but he lives in Canada. Her mother is supportive, but the patient does not live with her.
resiliency, the records support a score of 3. The patient has had equivocal resiliency and response to treatment. Her previous treatment has not managed her substance use and depression. With regards to
and engagement, the records support a score of 3. The patient has trouble with authoritarian figures. She has difficulty committing to a treatment plan and has difficulty committing to future sobriety. She can be redirected and will engage at times and will | Upheld | Medical Necessity | Summary Reviewer
The parent of a 16-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health residential treatment from 12/07/17 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that the Child and Adolescent Level of Care Utilization System (CALOCUS) is an accepted, national standard for determining the appropriate level of care for children and adolescents. In terms of risk of harm, the records support a score of 3. The patient had one prior suicide attempt on 4/03/17. On 12/08/17, the patient did not have any suicidal ideation. There is a concern that the patients substance use could result in an accidental overdose. With regards to functional status, the records support a score of 3. The patient had moderate functional impairment. She has conflicted relationships with her parents and peers. The patient has a history of running away from school and home. She has made modest behavioral improvements during her residential treatment center stay. In terms of comorbidity, the records support a score of 3. The patient has comorbidities of major depressive disorder, attention deficit/hyperactivity disorder, cannabis use disorder, and alcohol use disorder. The patient does not have any major medical problems which would require 24-hour monitoring. In terms of environmental stress, the records support a score of 3. The patients family situation is disrupted. With regards to environmental supports, the records support a score of 3. There is limited support in her environment. The patients father would like to be involved in the patients care, but he lives in Canada. Her mother is supportive, but the patient does not live with her. In terms of resiliency, the records support a score of 3. The patient has had equivocal resiliency and response to treatment. Her previous treatment has not managed her substance use and depression. With regards to acceptance and engagement, the records support a score of 3. The patient has trouble with authoritarian figures. She has difficulty committing to a treatment plan and has difficulty committing to future sobriety. She can be redirected and will engage at times and will apologize for previous behavior during times of increased insight. Thus, the patient has a composite score of 21. Based on these criteria, the patient meets criteria for a partial hospitalization program (PHP) and could be treated in a less restrictive environment. The patient continued to need treatment for her major depressive disorder, attention deficit/hyperactivity disorder, cannabis use disorder, and alcohol use disorder, but this could have been done in a less restrictive environment. Thus, mental health residential treatment from 12/07/17 forward was not and is not medically necessary for the treatment of this patient. Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 55-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 5/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 2
A 55-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 5/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient has an early stage melanoma. Commercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. All told, DecisionDx-Melanoma testing provided on 5/29/19 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 39-year-old male enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees gastroesophageal reflux disease (GERD).
In this case, the patient has undergone only some of this pre-operative assessment. Moreover, this patient presents with GERD with finding of short-segment | Upheld | Experimental | Summary Reviewer 2
A 39-year-old male enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found the appropriate patient selection is crucial before anti-reflux procedures. In prelude to surgical intervention for GERD, it is critical to document the presence of abnormal distal esophageal acid exposure, especially when anti-reflux surgery is considered, and reflux-related symptoms should be severe enough to outweigh the potential side effects of fundoplication. Each testing modality has a specific role in the diagnosis and workup of GERD, and no single test alone can provide the entire clinical picture. Results of testing are combined to document the presence and extent of the disease and assist in planning the operative approach. Currently, upper endoscopy, barium esophagram, pH testing, and manometry are required for preoperative workup for anti-reflux surgery (Jobe, et al). In this case, the patient has undergone only some of this pre-operative assessment. Moreover, this patient presents with GERD with finding of short-segment Barretts esophagus and implantation of LINX has not been studied in patients with Barrett's esophagus (USC Keck School of Medicine). Therefore, the LINX procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested 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 parent of a 16-year-old female enrollee has requested reimbursement for mental health residential level of care provided from 7/17/19 through 9/17/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
. The medical records indicate that the patient was not actively suicidal, but she did have a history of speaking of suicide and some mention of thoughts without plan during treatment. Further, there is history of a previous suicide attempt in the past.
The patient demonstrated significant improvement in function following a period of deterioration. She had good grades in school prior to admission.
that the patient had not engaged in significant treatment prior to residential treatment admission. Per the records, her only treatment was weekly | Upheld | Medical Necessity | Summary Reviewer
The parent of a 16-year-old female enrollee has requested reimbursement for mental health residential level of care provided from 7/17/19 through 9/17/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) provides a reliable framework for determining the appropriate level of care for adolescents needing mental health treatment. In terms of risk of harm, the records support a score of 3. The medical records indicate that the patient was not actively suicidal, but she did have a history of speaking of suicide and some mention of thoughts without plan during treatment. Further, there is history of a previous suicide attempt in the past. With regards to functional status, the records support a score of 2. The patient demonstrated significant improvement in function following a period of deterioration. She had good grades in school prior to admission. In terms of comorbidity, the records support a score of 1. The patient did not have active medical problems or active substance use issues. With regards to level of stress of the recovery environment, the records support a score of 2. There was no indication of an unsafe home environment. In terms of level of support of the recovery environment, the records support a score of 2. The patients family was actively involved in treatment on a regular basis. With regards to resiliency and treatment history, the records support a score of 3. It appears that the patient had not engaged in significant treatment prior to residential treatment admission. Per the records, her only treatment was weekly therapy, which did not appear adequate for her symptoms. It would not be expected that symptoms would resolve with this minimal outpatient treatment and no psychiatric management. In terms of acceptance and engagement of the patient, the records support a score of 2. The patient was cooperative in treatment. With regards to acceptance and engagement of the parent, the records support a score of 2. The parents worked actively and constructively with clinicians on a regular basis. Thus, the patient has a composite score of 17. This score correlates with intensive outpatient services. Therefore, mental health residential level of care provided from 7/17/19 through 9/17/19 was not medically necessary for the treatment of this patient. | 1 |
A 39-year-old female enrollee has requested reimbursement for Prometheus Anser ADA testing performed on 1/27/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 39-year-old female enrollee has requested reimbursement for Prometheus Anser ADA testing performed on 1/27/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the testing at issue was not likely to be more effective for this patient than other available options. Prometheus Anser ADA 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. There are few well controlled clinical trials to confirm that use of the Prometheus Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. Generally, except on a rare case-by-case basis, diminished or suboptimal response to infliximab or adalimumab can be managed in several ways such as shortening the interval between doses, increasing the dose, switching to a different anti-tumor necrosis factor (TNF) agent (in patients who continue to have loss of response after receiving the increased dose), or switching to a non-anti-TNF agent based on clinical observation in lieu of Prometheus Anser ADA testing. In this case, the Anser testing was of questionable clinical significance. Moreover, the Prometheus Anser ADA results did not immediately alter the patients treatment course or result in a net positive clinical outcome. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 58-year-old male with a left-sided clinical stage IV invasive breast cancer that is estrogen receptor (ER) positive, progesterone receptor (PR) positive, Her2 negative, and grade 3. He has a single bone metastasis in the right acetabulum. He was treated with neoadjuvant chemotherapy followed by mastectomy with sentinel lymph node biopsy. Pathology showed a good response to chemotherapy with negative margins. Repeat positron emission/computed tomography (PET/CT) showed uptake limited to the right acetabulum. The patient has requested authorization and coverage for stereotactic body radiotherapy (SBRT). The Health Insurer has denied this request indicating that the requested services are considered investigational. | Overturned | Experimental | Summary Reviewer 2
The patient is a 58-year-old male with a left-sided clinical stage IV invasive breast cancer that is estrogen receptor (ER) positive, progesterone receptor (PR) positive, Her2 negative, and grade 3. He has a single bone metastasis in the right acetabulum. He was treated with neoadjuvant chemotherapy followed by mastectomy with sentinel lymph node biopsy. Pathology showed a good response to chemotherapy with negative margins. Repeat positron emission/computed tomography (PET/CT) showed uptake limited to the right acetabulum. The patient has requested authorization and coverage for stereotactic body radiotherapy (SBRT). The Health Insurer has denied this request indicating that the requested services are considered investigational. After review of available studies, the requested SBRT is likely to be more beneficial for the patients solitary bone metastasis secondary to breast cancer than conventional treatment consisting of conventionally fractionated radiotherapy. The current data demonstrates superior and more durable local control with SBRT for oligo-bone metastases with low toxicity. Chow and colleagues performed a systematic review of several different regimens of conventionally fractionated radiotherapy and demonstrated an overall response rate of approximately 60% with SBRT. Owen and colleagues reported on 74 patients with oligometastatic non-spine bony metastases of varying histologies that were treated with SBRT resulted in a one year local control rate of 91%. In this clinical scenario, it would be advantageous to provide a treatment for this patients bone metastasis with an expected response rate greater than 60%. Thus, the requested SBRT is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 49-year-old male enrollee has requested reimbursement for the platelet rich plasma injection performed on 1/4/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees left foot pain.
that the patient has failed splinting, oral anti-inflammatory medications, steroid injections, as well as orthotics. | Upheld | Experimental | Summary Reviewer 1
A 49-year-old male enrollee has requested reimbursement for the platelet rich plasma injection performed on 1/4/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees left foot pain. The physician reviewer found the platelet rich plasma injection performed on 1/4/17 was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The documentation submitted for review indicates that the patient has failed splinting, oral anti-inflammatory medications, steroid injections, as well as orthotics. Length of time of each treatment, number of injections, and strength of injections is needed to assess whether patient has undergone proper conservative treatment. Furthermore, it does not appear the patient has undergone the standard of care treatments for posterior tibial tendon dysfunction including immobilization and casting. Furthermore, platelet rich plasma injections have demonstrated only mild efficacy for certain pathologies including plantar fasciitis, as well as tendon dysfunctions. Studies advise that further research is needed to fully understand the efficacy of platelet rich plasma, especially in joint pain and arthritis. For the reasons provided, the service at issue 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.
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The parent of a four-year-old male enrollee has requested reimbursement for comparative genomic hybridization performed on 1/19/15. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
The parent of a four-year-old male enrollee has requested reimbursement for comparative genomic hybridization performed on 1/19/15. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found Array-based comparative genomic hybridization has become standard of care to investigate children with developmental delay, intellectual disability, autism spectrum disorders or congenital anomalies. Until recently, it was a diagnostic test that was employed when the first-line investigation of karyotype returned normal. Over the last eight years, it has emerged as a first-line investigation. This test has become an important and mainstream tool in the practice of clinical genetics. Data have now emerged showing that actionable findings from chromosomal microarray justify its use. All told, comparative genomic hybridization performed on 1/19/15 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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A 50-year-old female enrollee has requested reimbursement for the injection of periurethral bulking agent provided on 12/19/14. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees recurrent stress urinary incontinence and intrinsic urethral sphincter deficiency. | Overturned | Experimental | Summary Reviewer 3
A 50-year-old female enrollee has requested reimbursement for the injection of periurethral bulking agent provided on 12/19/14. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees recurrent stress urinary incontinence and intrinsic urethral sphincter deficiency. The physician reviewer found that endoscopic bulking is an accepted option specifically under this clinical scenario as noted in the American Urological Association (AUA) guidelines on incontinence. There is adequate data that endoscopic bulking is the least invasive among the available treatment options and most likely to improve this patients clinical concern of stress incontinence with intrinsic sphincter deficiency. All told, the injection of periurethral bulking agent provided on 12/19/14 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 22-year-old male enrollee has requested reimbursement for surgical treatment of femoroacetabular impingement syndrome performed on 12/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees hip pain.
This patient with chronic function-limiting right hip pain. Clinical examination findings were consistent with imaging and radiographic evidence of a right hip labral tear and femoroacetabular impingement syndrome. There was no
on clinical examination. He underwent right hip arthroscopic labral repair, acetabular rim trimming, femoral osteochondroplasty, and capsular plication on 12/23/15. | Overturned | Experimental | Summary Reviewer 1
A 22-year-old male enrollee has requested reimbursement for surgical treatment of femoroacetabular impingement syndrome performed on 12/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees hip pain. The physician reviewer found there is limited level 3 and 4 evidence in the current evidence-based medical literature in support of the addition of capsular plication for arthroscopic treatment of femoroacetabular impingement syndrome, with additional longer term outcome studies recommended. This patient with chronic function-limiting right hip pain. Clinical examination findings were consistent with imaging and radiographic evidence of a right hip labral tear and femoroacetabular impingement syndrome. There was no documentation of hip instability on clinical examination. He underwent right hip arthroscopic labral repair, acetabular rim trimming, femoral osteochondroplasty, and capsular plication on 12/23/15. There is a lack of large volume, long-term peer-reviewed outcome studies to support the use of capsular plication for the treatment of femoroacetabular impingement syndrome. Therefore, surgical treatment of femoroacetabular impingement syndrome performed on 12/23/15 was not likely to have been superior over other available treatment alternatives. 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 14-year-old male enrollee has requested reimbursement for residential mental health treatment center services provided from 9/27/16 through 11/22/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
for review, the patient was cooperative with staff and his activities of daily living were intact.
. There were no significant or severe behavioral problems noted during his stay and his mood was noted to be frequently euthymic. The records document that at times he was noted to be depressed and tearful. The patient reported that he was able to use coping skills that he learned in therapy to deal with conflict with peers and emotional struggles. The patient was receiving DBT at the residential treatment center.
the patient could have been treated with DBT therapy on an outpatient basis due to his cooperation level and lack of safety concerns. The patients acute psychiatric symptoms had improved during the first several weeks of his treatment. He was benefiting from individual and group therapy and,
he was not experiencing self-harm behaviors. His functional status was moderate at three (3), as he had some school disruption | Upheld | Medical Necessity | Summary Reviewer
The parent of a 14-year-old male enrollee has requested reimbursement for residential mental health treatment center services provided from 9/27/16 through 11/22/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the RTC services provided from 9/27/16 through 11/22/16 were not medically necessary for treatment of the patients medical condition. According to the documentation submitted for review, the patient was cooperative with staff and his activities of daily living were intact. The medical records do not support active suicidal ideation or psychosis during the disputed period. There were no significant or severe behavioral problems noted during his stay and his mood was noted to be frequently euthymic. The records document that at times he was noted to be depressed and tearful. The patient reported that he was able to use coping skills that he learned in therapy to deal with conflict with peers and emotional struggles. The patient was receiving DBT at the residential treatment center. DBT is routinely provided on an outpatient basis providing that a patient is safe to participate in this type of therapy in that setting. In this case, the patient could have been treated with DBT therapy on an outpatient basis due to his cooperation level and lack of safety concerns. The patients acute psychiatric symptoms had improved during the first several weeks of his treatment. He was benefiting from individual and group therapy and, due to his participation level, insight and lack of dangerous behaviors could then have transitioned to a lower level of care. Based on the Child and Adolescent Level of Care Utilization System (CALOCUS), the patient scored a composite score of 17, which correlates with a treatment intensity level of three (3) which correlates with intensive outpatient services. This score is judged by the acuity of the patients symptoms and environment during the period under dispute at the RTC. The patients risk of harm was at two (2) due to his history of suicidal ideation. However, the medical records indicate the suicidal ideation was more passive in nature and not active ideation. During the disputed period he was not experiencing self-harm behaviors. His functional status was moderate at three (3), as he had some school disruption and is able to complete his activities in daily living in an age appropriate manner. His co-morbidity is one (1), the patient does not have active serious medical problems or any substance use diagnosis. His recovery environment is mild at two (2), the patient has a positive recovery environment and a stable housing situation. His recovery environment level of support is supportive at two (2). His family is actively involved in treatment and attend family therapy sessions on a regular basis, the patient reported that his family visits were positive and he looked forward to them. His resiliency and treatment history scored at three (3) due to positive treatment response in the recent past. His acceptance and engagement, was constructive at two (2), the patient actively participated in therapy and has used coping skills learned in therapy on numerous occasions His parents acceptance and engagement was also at two (2), the parents work actively and constructively with clinicians. According to the CALOCUS the beneficiary would need to have a score of 23-28 in order to require treatment in an RTC. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
The parent of a 17-year-old female enrollee has requested authorization and coverage for transcranial magnetic stimulation device. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of the enrollees behavioral health conditions.
This patient has a history of chronic migraine which evolved into chronic daily headache following three concussions. She has had inadequate symptom relief from both prophylactic and acute abortive medications, together with a variety of non-pharmacologic therapies. She has had an excellent response to transcranial magnetic stimulation, with a decrease in her headache frequency from daily headaches to two to four headaches per month. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 17-year-old female enrollee has requested authorization and coverage for transcranial magnetic stimulation device. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation supports the requested device in this clinical setting. This patient has a history of chronic migraine which evolved into chronic daily headache following three concussions. She has had inadequate symptom relief from both prophylactic and acute abortive medications, together with a variety of non-pharmacologic therapies. She has had an excellent response to transcranial magnetic stimulation, with a decrease in her headache frequency from daily headaches to two to four headaches per month. Irwin and colleagues conducted an open-label prospective pilot feasibility study of single-pulse transcranial magnetic stimulation (sTMS) for migraine prevention in adolescents aged 12-17 years. Participants used sTMS twice daily in a preventative fashion, as well as additional pulses as needed acutely. A four-week baseline run-in period (weeks 1-4) was followed by a 12-week treatment period. The authors concluded that sTMS appears to be a feasible, well-tolerated, and acceptable nonpharmacologic preventive treatment for migraine in adolescents. There is sufficient support for the requested device in this clinical setting. Therefore, the requested transcranial magnetic stimulation device is medically necessary for the treatment of this patient. | 1 |
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.
this patient underwent prenatal testing on 6/13/19. She was pregnant at 11 weeks 2 days gestation at the time of services. This was her second pregnancy, and an earlier pregnancy ended in a spontaneous miscarriage. | Upheld | Experimental | Summary Reviewer 1
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 this patient underwent prenatal testing on 6/13/19. She was pregnant at 11 weeks 2 days gestation at the time of services. This was her second pregnancy, and an earlier pregnancy ended in a spontaneous miscarriage. Noninvasive prenatal screening by cell-free DNA is increasingly becoming accepted as an appropriate method for first trimester aneuploidy screening. Noninvasive prenatal screening is a sensitive screen for aneuploidy. It is more sensitive than sequential screening, but does not require the invasive procedure of chorionic villus sampling or amniocentesis. This is the case for both younger women and for women of advanced maternal age. Offering diagnostic testing via chorionic villus sampling or amniocentesis is considered standard accepted practice in women over 35 years at the time of delivery, and noninvasive prenatal screening by cell-free DNA testing should also be considered standard. Therefore, fetal sex chromosome analysis (CPT 81599) performed on 6/13/19 was likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
The parent of a 13-year-old female enrollee has requested reimbursement for transcutaneous electrical modulation pain processing provided from 12/03/18 through 5/14/19. 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 patient is experiencing exacerbations of pain from complex regional pain syndrome that has been refractory to other treatments, and she has | Overturned | Experimental | Summary Reviewer 1
The parent of a 13-year-old female enrollee has requested reimbursement for transcutaneous electrical modulation pain processing provided from 12/03/18 through 5/14/19. 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 complex regional pain syndrome is a debilitating chronic pain syndrome that poses incredible challenges to the patient. Clear pathophysiology of complex regional pain syndrome is still being understood, and treatment options are primarily based on clinical experience and individual patients response to therapies, as strong evidence-based treatment options are lacking. A recent review by Shim and colleagues highlighted early use of physical/occupational therapy with neuropathic medications. Neuromodulation is also an option with evidence for appropriate candidates.
Scrambler Therapy is an electro-analgesia therapy with the intent to re-organize maladaptive signaling pathways that exist in chronic pain. It is used for the treatment of cancer pain, chronic neuropathic pain and refractory pain conditions. A review by Majithia and colleagues concluded that findings from available studies support Scrambler Therapy as a beneficial treatment option for patients with refractory pain syndromes. An observational study by Ricci and colleagues consisting of 219 patients with chronic pain treated with Scrambler Therapy showed a statistically significant impact of Scrambler Therapy. In this case, the patient is experiencing exacerbations of pain from complex regional pain syndrome that has been refractory to other treatments, and she has benefited from Scrambler Therapy in the past. Therefore, transcutaneous electrical modulation pain processing provided from 12/03/18 through 5/14/19 was likely to have been more beneficial than any available standard therapy.
| 1 |
The patient is a 17-year-old female with a medical history significant for daily migraine headaches refractory to standard outpatient management, periods of nausea and dizziness, and a diagnosis of postural orthostatic tachycardia syndrome (POTS). The records documented concern for an underlying mitochondrial disorder as the unifying diagnosis for her complex symptomatology. Thus, mitochondrial genome sequencing was ordered and performed. The Health Insurer has denied reimbursement for genetic testing (mitochondrial genome sequencing) performed on 12/31/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient. | Overturned | Experimental | Summary Reviewer 2
The patient is a 17-year-old female with a medical history significant for daily migraine headaches refractory to standard outpatient management, periods of nausea and dizziness, and a diagnosis of postural orthostatic tachycardia syndrome (POTS). The records documented concern for an underlying mitochondrial disorder as the unifying diagnosis for her complex symptomatology. Thus, mitochondrial genome sequencing was ordered and performed. The Health Insurer has denied reimbursement for genetic testing (mitochondrial genome sequencing) performed on 12/31/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient. Mitochondria are responsible for cellular energy production in nucleated cells. Dysfunction may occur as a result of defects in either mitochondrial DNA or nuclear mitochondrial genes, and resulting disease may present in either adulthood or childhood. Symptoms may affect one organ or may involve multiple systems. While there is no cure for mitochondrial disease at present, genetic diagnosis is essential for guiding supportive care, as well as providing counselling to families and the patient. Next generation sequencing techniques have been invaluable in diagnosing patients with clinical findings suggestive of mitochondrial disease. In this patients case, she has numerous clinical and biochemical abnormalities that have raised the question of mitochondrial disorder. The information provided by next generation sequencing was important for guiding her future care. In sum, genetic testing (mitochondrial genome sequencing) performed on 12/31/16 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 59-year-old male enrollee has requested reimbursement for the UroLift procedure performed on 4/3/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees elevated prostate specific antigen (PSA) and enlarged prostate with lower urinary tract symptoms. | Overturned | Experimental | Summary Reviewer 3
A 59-year-old male enrollee has requested reimbursement for the UroLift procedure performed on 4/3/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees elevated prostate specific antigen (PSA) and enlarged prostate with lower urinary tract symptoms. The physician reviewer found that in the peer-reviewed medical literature, Roehrborn and colleagues reported five year data on treatment of BPH with prostatic UroLift resulted in decreased risk of incontinence, impotence, and bleeding. The minimally invasive nature of the UroLift also makes it an acceptable alternative to medications with difficult side effects particularly in younger patients. Further, prostatic UroLift data before April 2017 demonstrated that this surgery did not preclude more invasive treatment if warranted. Given this support, the UroLift procedure performed on 4/3/17 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 15-year-old female diagnosed with major depressive disorder, recurrent, severe, alcohol use disorder, severe, and self-harm. The records dated 2/8/17 reveal that she was admitted to intensive outpatient program (IOP) therapy on 2/9/17. During the course of treatment, the patient has described detachment and possible dissociation and is described herself as a mediator between her parents. On 4/10/17, she indicated in group therapy that she does not express her anger in adaptive ways and in the past drank alcohol as a method of coping. She indicated that she wanted to learn more adaptive strategies. Her parent has requested reimbursement and prospective authorization and coverage for mental health IOP services from 4/10/17 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary. By 4/10/17, the patient is noted to have a rather sophisticated understanding of her behavior in response to the dysfunction of her family. She appeared to be prepared to continue individual therapy supported by psychotropic medication. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 15-year-old female diagnosed with major depressive disorder, recurrent, severe, alcohol use disorder, severe, and self-harm. The records dated 2/8/17 reveal that she was admitted to intensive outpatient program (IOP) therapy on 2/9/17. During the course of treatment, the patient has described detachment and possible dissociation and is described herself as a mediator between her parents. On 4/10/17, she indicated in group therapy that she does not express her anger in adaptive ways and in the past drank alcohol as a method of coping. She indicated that she wanted to learn more adaptive strategies. Her parent has requested reimbursement and prospective authorization and coverage for mental health IOP services from 4/10/17 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary. By 4/10/17, the patient is noted to have a rather sophisticated understanding of her behavior in response to the dysfunction of her family. She appeared to be prepared to continue individual therapy supported by psychotropic medication. In addition to her diagnoses of major depression, and substance abuse, consideration might have been given to reactive attachment disorder with focus on treatments such as acceptance and commitment therapy as well as intensive in-home therapy with multiple systems therapy. These considerations are important because of the patients own experience of having to mediate conflict within the family (Cohen, et al). All told, the records provided for review do not support the medical necessity of the IOP services provided to this patient from 4/10/17 forward. Based on the foregoing discussion, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 36-year-old female enrollee has requested reimbursement and prospective authorization and coverage for outpatient mental health services provided from 12/17/14 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition.
the patient presents with major depressive disorder and posttraumatic stress disorder with pathology | Overturned | Medical Necessity | Summary Reviewer
A 36-year-old female enrollee has requested reimbursement and prospective authorization and coverage for outpatient mental health services provided from 12/17/14 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that according to the documentation submitted for review, the patient presents with major depressive disorder and posttraumatic stress disorder with pathology steeped in psychodynamic and characterological theory. Psychodynamic psychotherapy is a trusted intervention in the treatment armamentarium for those afflicted with major depressive disorder. Per the American Psychiatric Association (APA) clinical practice guideline, Psychodynamic psychotherapy may be brief but usually has a longer duration than other psychotherapies, and its aims extend beyond immediate symptom relief. These goals are to modify underlying psychological conflicts and deficits, which increase the patients vulnerability to depressive affect and the development of major depressive disorder. Although not an evidence-based therapy for posttraumatic stress disorder akin to cognitive processing therapy or prolonged exposure, per the VA/DoD clinical practice guideline, psychodynamic psychotherapy is recognized as having some benefit with fair evidence that it can improve health outcomes for those diagnosed with PTSD. Thus, contemporary practice standards and evidence-based treatment guidelines support the appropriateness of the intervention in this particular case. However, in the absence of treatment records such as a psychiatric evaluation, psychological assessment with testing, interpretative summary, progress notes, objective rating scales and treatment plan updates, the reasonableness of the intervention, in particular the duration and frequency of the therapy, cannot be determined. According to APA guidelines It can be useful to establish an expected duration of psychotherapy at the start of treatment. Communicating this expectation may help mobilize the patient and focus treatment goals, yet there are few data available on the optimal duration of specific depression-focused psychotherapies.The optimal frequency of psychotherapy has not been rigorously studied in controlled trials.Regardless of the type of depression-focused psychotherapy that is selected, the clinician should carefully and systematically monitor the patients response to treatment, which can be facilitated by the use of clinician and patient rated scales at regular intervals. If 48 weeks of treatment do not yield at least moderate improvement (=20% diminution in symptoms), the clinician should thoroughly review and reappraise the treatment plan. In this case, the absence of treatment records does not make it possible to assert with any degree of confidence that the disputed therapy is improving the patients condition and/or preventing a more serious episode of illness. In the absence of any additional clinical documentation supporting the treatment plan from 4/15/15, the disputed service cannot be considered medically necessary after an eight-week interval, which correlates with a date of 6/15/15. As such, the outpatient mental health services provided from 12/17/14 through 6/15/15 was medically necessary, but not thereafter. Therefore, a portion of the services at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
| 1 |
A 61-year-old male enrollee has requested reimbursement for the Life Vest provided on 5/23/14. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees congestive heart failure and atrial fibrillation.
, the patient presented with newly recognized severe left ventricular dysfunction in the setting of rapid atrial fibrillation and liver enzyme elevation. | Upheld | Experimental | Summary Reviewer 1
A 61-year-old male enrollee has requested reimbursement for the Life Vest provided on 5/23/14. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees congestive heart failure and atrial fibrillation. The physician reviewer found that based on the records provided, the patient presented with newly recognized severe left ventricular dysfunction in the setting of rapid atrial fibrillation and liver enzyme elevation. In this circumstance, there is potential for recovery of left ventricular function over time with medical therapy. Moreover, there was no indication for immediate placement of a defibrillator such as sustained or inducible ventricular tachycardia, syncope or aborted sudden cardiac arrest. Placement of a prophylactic defibrillator is not recommended until at least 90 days have elapsed when continued left ventricular dysfunction is documented to persist in spite of appropriate treatment (Russo, et al). A prophylactic defibrillator (wearable or implantable) before this time has not been demonstrated to improve outcome. Studies assessing the efficacy of prophylactic defibrillators early after diagnosis of myocardial infarction and reduced ejection fraction of 35% or less before ventricular function has had a chance to recover have not demonstrated improved outcome (Hohnloser, et al). Also, studies evaluating wearable defibrillators during periods of increased risk where criteria for implantable defibrillators have not yet been met are largely comprised of registry data without adequate control groups (Chung, et al). Given these findings, the Life Vest provided to this patient on 5/23/14 was not likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the device at issue was 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 68-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with endocardial implant (Watchman device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees atrial fibrillation.
for anticoagulation therapy, but he had a major gastrointestinal bleed while on anticoagulation therapy. His provider noted that the patient remains at risk for recurrent gastrointestinal bleeding if he remains on the required lifelong anticoagulation. | Overturned | Experimental | Summary Reviewer 1
A 68-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with endocardial implant (Watchman device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees atrial fibrillation. The physician reviewer found that patient has an absolute indication for anticoagulation therapy, but he had a major gastrointestinal bleed while on anticoagulation therapy. His provider noted that the patient remains at risk for recurrent gastrointestinal bleeding if he remains on the required lifelong anticoagulation. The Watchman device can obviate the need for long-term anticoagulation in patients at risk for significant bleeding, as is the case with this patient. The Watchman device is both a safe and effective alternative to prevent recurrent stroke in patients with persistent atrial fibrillation who are at high bleeding risk during long-term anticoagulation therapy. Therefore, the requested percutaneous transcatheter closure of the left atrial appendage with endocardial implant (Watchman device) is likely to be of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 55-year-old male has requested reimbursement for high-intensity focused ultrasound performed on 8/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees prostate cancer. | Upheld | Experimental | Summary Reviewer 1
A 55-year-old male has requested reimbursement for high-intensity focused ultrasound performed on 8/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that high-intensity focused ultrasound has increasingly been used for treatment of localized prostate cancer within the last decade. It has the theoretical potential of decreasing gastrointestinal, genitourinary and sexual toxicity. Potential candidates are patients with low to moderate risk prostate cancer. The available literature mainly consists of prospective case series and retrospective studies showing short to intermediate term outcomes for localized prostate cancer. There is a lack of controlled trials available for analysis, and a lack of long-term survival data is available. There are no validated biochemical and surrogate end-point for cure. The National Comprehensive Cancer Network indicates that further study is warranted. The current evidence has not established the superior efficacy of the services at issue. Therefore, high-intensity focused ultrasound performed on 8/14/17 was not likely to have been of greater benefit than other 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.
| 1 |
A 41-year-old male enrollee has requested reimbursement for elastase pancreatic fecal and fecal calprotectin laboratory testing performed on 8/03/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
The records document chronic diarrhea. This patients symptoms included abdominal bloating, intermittent watery diarrhea and rectal itching. The documentation noted that the patient tested negative for celiac disease in the past. | Upheld | Experimental | Summary Reviewer 3
A 41-year-old male enrollee has requested reimbursement for elastase pancreatic fecal and fecal calprotectin laboratory testing performed on 8/03/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. The records document chronic diarrhea. This patients symptoms included abdominal bloating, intermittent watery diarrhea and rectal itching. The documentation noted that the patient tested negative for celiac disease in the past. Expert guidelines for the evaluation of chronic diarrhea have recommended fecal calprotectin testing in the evaluation of diarrhea, as a surrogate for fecal leukocyte testing. This testing can identify whether an inflammatory cause for diarrhea is present. Thus, fecal calprotectin laboratory testing performed on 8/03/18 was likely to have been more effective than other methods of evaluating this patient.
| 1 |
The patient is a 57-year-old male with a history of AL amyloidosis with cardiac involvement. Computed tomography (CT) imaging of the pelvis with contrast on 12/21/16 for a history of amyloid light chain amyloidosis revealed stable small pericardial effusion and bilateral renal cysts, unchanged from 5/27/16. The provider reports the patient has been treated with Cytoxan, dexamethasone, Velcade, and Kyprolis. The providers treatment plan is to start Darzalex if these medications are not effective. 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. | Overturned | Experimental | Summary Reviewer 1
The patient is a 57-year-old male with a history of AL amyloidosis with cardiac involvement. Computed tomography (CT) imaging of the pelvis with contrast on 12/21/16 for a history of amyloid light chain amyloidosis revealed stable small pericardial effusion and bilateral renal cysts, unchanged from 5/27/16. The provider reports the patient has been treated with Cytoxan, dexamethasone, Velcade, and Kyprolis. The providers treatment plan is to start Darzalex if these medications are not effective. 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. As reported in the peer-reviewed medical literature, Darzalex was tested in previously treated patients with systemic amyloidosis in two phase II studies (Roussel, et al; Sanchorawala, et al). In these studies, hematologic response rates were approximately 60%, with positive organ responses, and reductions in serum free light chain levels. Given this support, the requested Darzalex is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 68-year old male with a history of diabetes, hypertension and hyperlipidemia.
The patient has requested reimbursement for hospital services provided from 11/13/21
through 11/15/21.
records, this patient had
significant cardiac risk. The documentation noted recently diagnosed rapid atrial fibrillation
with persistent symptoms despite initiation on rate control medication (metoprolol) and
anticoagulation (Xarelto) as an outpatient. Moreover, unexplained left ventricular dysfunction
is noted. His troponin was elevated, suggesting possible non ST segment elevation myocardial
infarction. The patients heart rate has not adequately controlled on medical therapy and
congestion had developed on chest x-ray despite outpatient therapy. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 68-year old male with a history of diabetes, hypertension and hyperlipidemia.
The patient has requested reimbursement for hospital services provided from 11/13/21
through 11/15/21. The physician reviewer found that based on the records, this patient had
significant cardiac risk. The documentation noted recently diagnosed rapid atrial fibrillation
with persistent symptoms despite initiation on rate control medication (metoprolol) and
anticoagulation (Xarelto) as an outpatient. Moreover, unexplained left ventricular dysfunction
is noted. His troponin was elevated, suggesting possible non ST segment elevation myocardial
infarction. The patients heart rate has not adequately controlled on medical therapy and
congestion had developed on chest x-ray despite outpatient therapy. In this clinical setting,
inpatient admission is medically indicated to establish better rate control and to evaluate for
acute coronary ischemia. Current guidelines support inpatient admission in this setting.
Therefore, hospital services provided from 11/13/21 through 11/15/21 were medically
necessary for the treatment of this patient. | 1 |
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Health Insurance Appeal Adjudication Benchmark
This data repository houses manually labeled, and pseudo-labeled background spans corresponding to real external appeal adjudications for coverage denials from U.S. health insurance cases. The data is referenced by and described in a more general work documented here: https://github.com/TPAFS/hicric.
Contact
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