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The parent of a 14-year-old male enrollee has requested reimbursement for wilderness treatment therapy provided from 7/16/18 through 8/30/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
The parent of a 14-year-old male enrollee has requested reimbursement for wilderness treatment therapy provided from 7/16/18 through 8/30/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that the records do not document other levels of care such as inpatient psychiatric hospitalization, partial hospital treatment, residential treatment, or use of psychopharmacotherapy to address the patients condition. While the review of the literature indicates some effect with wilderness therapy, there is a lack of comparison studies of standard residential treatment to wilderness therapy. A review of the literature indicates that the most effective treatment of attention deficit/hyperactivity disorder (ADHD) is stimulant medication with or without behavioral therapy. Several studies show effectiveness for psychotherapies for disruptive mood dysregulation disorder (DMDD), but further study is needed. All told, wilderness treatment therapy provided from 7/16/18 through 8/30/18 was not likely to have been more beneficial than other treatment options.
| 0 |
The patient is a 59-year-old male who presented to his provider on 9/15/21. The patient has
requested authorization and coverage for liver cancer radiation therapy using two treatments of
selective internal radiation therapy (SIRT). The Health Insurer has denied this request and
reported that the requested service is not medically necessary for the treatment of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 59-year-old male who presented to his provider on 9/15/21. The patient has
requested authorization and coverage for liver cancer radiation therapy using two treatments of
selective internal radiation therapy (SIRT). The Health Insurer has denied this request and
reported that the requested service is not medically necessary for the treatment of this patient.
The physician reviewer found that the submitted documentation supports the medical necessity
of the requested service. Y90 radioembolization has been shown to be an effective targeted
treatment for tumors of the liver. In this case, an applicator is used to directly infuse
microspheres of Y90 into the tumors. These microspheres are delivered through arteries that
feed directly into the tumor and emit a radionuclide which kills cancer cells. This allows for a very
targeted dose to be delivered. Liver tissue is highly radiosensitive so targeted therapies are
critical to ensure lower liver toxicity. At present, Y90 therapy has demonstrated a favorable
therapeutic ratio with improved overall survival outcomes and low toxicity rates. While there is
a lack of prospective, randomized trials directly comparing Y90 and other similar targeted liver
therapies, Y90 has continued to demonstrate a good safety profile. Tsang and colleagues report
that Y90 was well-tolerated in patients with metastatic liver-dominant neuroendocrine tumors.
In phase 3 data combining Y90 therapy with systemic therapy in the setting liver metastases,
Chauhan and colleagues reported that the addition of the Y90 therapy showed significantly
longer progression-free survival and hepatic progression-free survival when combined with
chemotherapy or immunotherapy. Current medical literature corroborates the low toxicity and
improved overall survival data with Y90 therapy. In this case, there are a few key factors to take
into account. Firstly, the liver is a very radiosensitive organ, making targeted treatment delivery
critical. Y90 can deliver the radiation dose through the artery in a manner that touches only the
tumor. This cannot be achieved by external radiation methods such as stereotactic radiation
therapy (SBRT). Secondly, this patients liver metastases are very large with some of the lesions
measuring over 17 cm. Neither surgical resection nor external radiation treatment can safely
treat liver lesions that are this large. Only a directed trans-arterial method can safely deliver a
targeted treatment in this setting. Overall, Y90 has a track record of improving overall survival in
the setting of liver metastases with a fairly low toxicity profile. Given the disease burden seen
within this patients liver, directed Y90 radioembolization with targeting of the liver metastases
is medically indicated. Therefore, liver cancer radiation therapy using two treatments of SIRT is
medically necessary for the treatment of this patient.
| 1 |
The patient is a two-year-old male who presented for his two-year checkup on 7/11/22. The
patients parent has requested authorization and coverage for Synagis 100 mg/mL every 28 days
x five months. The Health Insurer has denied this request and reported that the requested
medication is not medically necessary for the treatment of this patient.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a two-year-old male who presented for his two-year checkup on 7/11/22. The
patients parent has requested authorization and coverage for Synagis 100 mg/mL every 28 days
x five months. The Health Insurer has denied this request and reported that the requested
medication is not medically necessary for the treatment of this patient. This denial is the subject
of this appeal and determination. The physician reviewer found that the submitted documentation
does not support the medical necessity of the requested medication. The Committee on Infectious
Disease and American Academy of Pediatrics recommend the use of palivizumab for the
administration of prophylaxis for the following groups of patients: preterm infants with chronic
lung disease (CLD) born at less than 32 weeks of gestation requiring supplemental oxygen for at
least the first 28 days of life, with consideration for a second year of prophylaxis if ongoing medical
support is required for CLD; children with hemodynamically significant congenital heart disease
(CHD) in their first respiratory syncytial virus (RSV) season, including those with acyanotic heart
disease receiving medication to control congestive heart failure and who will require surgical
intervention and those with moderate to severe pulmonary hypertension; infants with cyanotic
heart disease in their first RSV season in consultation with their cardiologist; infants with CHD
that receive RSV prophylaxis following surgical procedures requiring cardiopulmonary bypass,
due to a decrease in palivizumab serum concentration; children less than two years of age that
undergo cardiac transplantation during an RSV season; preterm infants born before 29 weeks of
gestation; infants with neuromuscular disease or congenital anomaly that impairs airway clearance;
children younger than 24 months that will be profoundly immunocompromised during the relevant
RSV season; and infants with cystic fibrosis complicated by CLD and/or nutritional compromise
for their first RSV season, and for a second season in the presence of severe lung disease.
Palivizumab prophylaxis is not recommended for any children over the age of 24 months. There
is lack of medical literature supporting its use or efficacy in this population. Luna and colleagues
report that expert consensus on palivizumab use for RSV recommends palivizumab for preterm
infants, former preterm children aged at or less than 24 months with CLD/bronchopulmonary
dysplasia, children aged at or less than 24 months with significant CHD, and other high-risk
populations, such as children aged at or less than 24 months with Down syndrome,
pulmonary/neuromuscular disorders, immunocompromised, and cystic fibrosis. Given that
palivizumab prophylaxis is not recommended in children over the age of 24 months, the requested
medication is not medically indicated. Therefore, Synagis 100 mg/mL every 28 days x five months
is not medically necessary for the treatment of this patient.
| 1 |
A 59-year-old female enrollee has requested reimbursement for HCMNext Reflex-Ambry genetic test performed on 10/2/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollee, who has a history of hypertrophic cardiomyopathy.
this patient has clinical features suggesting hypertrophic cardiomyopathy,
cardiac death. She had left ventricular septal hypertrophy by echocardiogram and a family history of sudden cardiac death.
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Overturned
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Experimental
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Summary Reviewer 3
A 59-year-old female enrollee has requested reimbursement for HCMNext Reflex-Ambry genetic test performed on 10/2/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollee, who has a history of hypertrophic cardiomyopathy. The physician reviewer found that this patient has clinical features suggesting hypertrophic cardiomyopathy, a genetic disease that may lead to heart failure or sudden cardiac death. She had left ventricular septal hypertrophy by echocardiogram and a family history of sudden cardiac death. Based on current Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA) guidelines, genetic testing is recommended ( a class I indication) for any patient in whom a cardiologist has established a clinical diagnosis of hypertrophic cardiomyopathy based on the patients clinical history, family history and EKG/ECHO phenotype. This patient meets these guideline criteria. Genetic testing was medically indicated and confirmed the diagnosis. As such, the genetic testing at issue was within standard of care. Therefore, HCMNext Reflex-Ambry genetic test performed on 10/2/17 was likely to have been more efficacious than the available modalities for evaluating this patients medical condition.
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 41-year-old male enrollee has requested reimbursement for transcranial magnetic stimulation (TMS) provided from 10/02/20 through 11/20/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition.
patient has failed multiple medication trials and continues to have depressive symptoms. He had experienced a positive response to TMS in the past, with an over 50% reduction in symptoms during that time.
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Overturned
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Experimental
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Summary Reviewer 2
A 41-year-old male enrollee has requested reimbursement for transcranial magnetic stimulation (TMS) provided from 10/02/20 through 11/20/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient has failed multiple medication trials and continues to have depressive symptoms. He had experienced a positive response to TMS in the past, with an over 50% reduction in symptoms during that time. TMS is currently approved for treating patients who are suffering from the acute phase of major depressive disorder. Given that this patient was still experiencing an acute episode, the medical evidence supports continued treatment. Therefore, TMS provided from 10/02/20 through 11/20/20 was likely to have been more beneficial than other available standard therapy.
| 1 |
A 25-year-old female enrollee has requested authorization and coverage for breast reduction surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition.
this patient has evidence of significant symptomatic macromastia. This is noted to affect her activities of daily living with exercise. Her stated symptoms include neck, back and shoulder pain, shoulder grooving and scarring from periodic ulcerations. Her photographs are supportive that her clinical condition and functional deficits are likely directly related to her macromastia.
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Overturned
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Medical Necessity
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Summary Reviewer
A 25-year-old female enrollee has requested authorization and coverage for breast reduction surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that this patient has evidence of significant symptomatic macromastia. This is noted to affect her activities of daily living with exercise. Her stated symptoms include neck, back and shoulder pain, shoulder grooving and scarring from periodic ulcerations. Her photographs are supportive that her clinical condition and functional deficits are likely directly related to her macromastia. There is sufficient support for the requested services in this patients case. Specifically, a 400 gram reduction is considered a significant reduction for a patient who is this size. In addition, she has failed conservative management. Breast reduction is a well-known procedure that directly addresses this functional deficit. In this patients case, breast reduction is standard of care. In sum, the requested breast reduction surgery is medically indicated for the treatment of this patient. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 51-year-old female enrollee has requested authorization and coverage for 64628 thermal
destruction of intraosseous basivertebral nerve. The Health Insurer has denied this request and
reported that the requested service is investigational for the treatment of the enrollees low back
pain.
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Overturned
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Experimental
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Summary Reviewer 3
A 51-year-old female enrollee has requested authorization and coverage for 64628 thermal
destruction of intraosseous basivertebral nerve. The Health Insurer has denied this request and
reported that the requested service is investigational for the treatment of the enrollees low back
pain. At issue is whether 64628 thermal destruction of intraosseous basivertebral nerve is likely
to be more beneficial for treatment of the enrollee's condition than any available standard therapy.
The physician reviewer found that chronic low back pain is a debilitating condition. When Modic
changes are present in the disc spaces, a vertebrogenic cause of back pain is considered an etiology
of chronic back pain. The main source of innervation for the vertebral body are the basivertebral
nerves. Ablation of the basivertebral nerve is a safe and effective procedure that is evidence based
for appropriately selected candidates. Sayed and colleagues report, The United States
Preventative Task Force (USPSTF) criteria for grading evidence gives basivertebral nerve ablation
Level A grade evidence with high certainty that the net benefit is substantial in appropriately
selected individuals. In a prospective, randomized, multicenter study, Khalil report that
basivertebral nerve ablation led to significant improvement of pain and function at three-months
in patients with chronic vertebrogenic related low back pain. Fischgrund and colleagues
demonstrated that patients treated with basivertebral nerve ablation patients sustained clinical
improvements in pain and improvement in function at a mean of 6.4 years following treatment. In
this case, the requested service is likely to be more beneficial than standard therapies such as
conservative care with physical therapy, medications, and procedural interventions such as lumbar
medial branch radiofrequency ablation. Therefore, 64628 thermal destruction of intraosseous
basivertebral nerve is likely to be more beneficial for treatment of the patients condition than any
available standard therapy.
| 1 |
A 42-year-old female enrollee has requested authorization and coverage for bilateral reduction mammoplasty. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees symptomatic bilateral macromastia.
In this case, the patient has severe symptomatic macromastia that has failed reasonable conservative measures. Her physical examination was consistent with significant macromastia that was supported by photographs showing significant shoulder grooving as well. The patient has documented back and shoulder pain, as well as shoulder grooving from bra straps. In addition, she has documented recurrent rashes that have failed conservative measures. Given the
review, the patient has a functional deficit directly related to macromastia that has failed
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Overturned
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Medical Necessity
|
Summary Reviewer
A 42-year-old female enrollee has requested authorization and coverage for bilateral reduction mammoplasty. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees symptomatic bilateral macromastia. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity for the requested services. According to American Society of Plastic Surgeons (ASPS) Symptomatic breast hypertrophy is defined as a syndrome of persistent neck and shoulder pain, painful shoulder grooving from brassiere straps, chronic intertriginous rash of the inframammary fold, and frequent episodes of headache, backache, and neuropathies caused by heavy breasts caused by an increase in the volume and weight of breast tissue beyond normal proportions. ASPS further state that based on the results of Level I and II Evidence, reduction mammaplasty has been proven effective at reducing macromastia related symptoms and improving postoperative quality of life. In this case, the patient has severe symptomatic macromastia that has failed reasonable conservative measures. Her physical examination was consistent with significant macromastia that was supported by photographs showing significant shoulder grooving as well. The patient has documented back and shoulder pain, as well as shoulder grooving from bra straps. In addition, she has documented recurrent rashes that have failed conservative measures. Given the documentation submitted for review, the patient has a functional deficit directly related to macromastia that has failed conservative management and would likely improve with surgical correction. Therefore, bilateral reduction mammoplasty is medically necessary in this clinical setting. For the reasons provided, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 48-year-old male enrollee has requested reimbursement for laboratory testing on 12/2/22. The Health
Insurer has denied this request and reported that services at issue were investigational for the
evaluation of the enrollees premature coronary artery disease and hyperlipidemia.
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Overturned
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Experimental
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Summary Reviewer 1
A 48-year-old male enrollee has requested reimbursement for laboratory testing on 12/2/22. The Health
Insurer has denied this request and reported that services at issue were investigational for the
evaluation of the enrollees premature coronary artery disease and hyperlipidemia. The physician
reviewer found that the current guidelines for the management of cardiac risk and dyslipidemia do not
recommend the routine performance of specialized tests, including screening lipoprotein(a) levels, in
the context of assessing coronary risk. Treatment changes or additions based on the results of
lipoprotein testing has not been shown to improve cardiac outcomes over those achievable through
treatment based on standard risk factor profiling and a basic lipid analysis. In this patients case, a high
dose-statin medication is recommended regardless of lipid levels or of lipoprotein(a) levels based on the
patients known coronary disease. There is a lack of evidence from clinical trials testing the hypothesis
that lipoprotein(a) reduction reduces the incidence of future cardiovascular events over those
achievable with standard therapy. Therefore, laboratory testing on 12/2/22 was not likely to have been
more beneficial for evaluation of the patients condition than any available standard therapy.
| 1 |
A 20-year-old male enrollee has requested authorization and coverage for residential substance use disorder treatment from 2/9/16 through 3/10/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
The patient presented with a CIWA score of 1 which is consistent with having mild withdrawals. By 2/9/16, he was not a danger to himself or others. He was medically and psychiatrically stable. He did not require a detoxification protocol.
. The psychiatric evaluation indicated that his impulse control appeared to be good. He was motivated and appeared to be working the program. Given his recent residential experience in August 2015, he had an educational exposure to relapse prevention, coping skills, and the 12 step program. His family was supportive in his efforts. He did
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Upheld
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Medical Necessity
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Summary Reviewer
A 20-year-old male enrollee has requested authorization and coverage for residential substance use disorder treatment from 2/9/16 through 3/10/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. The patient presented with a CIWA score of 1 which is consistent with having mild withdrawals. By 2/9/16, he was not a danger to himself or others. He was medically and psychiatrically stable. He did not require a detoxification protocol. There were no emotional, behavioral, cognitive, or impulsive symptoms that would warrant a residential treatment services level of care. The psychiatric evaluation indicated that his impulse control appeared to be good. He was motivated and appeared to be working the program. Given his recent residential experience in August 2015, he had an educational exposure to relapse prevention, coping skills, and the 12 step program. His family was supportive in his efforts. He did not require the 24 hour structure of residential and could have safely been treated at an ambulatory level of care such as an intensive outpatient program. As such, the residential substance use disorder treatment from 2/9/16 through 3/10/16 were not medically necessary. Therefore, for the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 52-year-old female enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 7/7/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees colonic Crohns disease.
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Overturned
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Experimental
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Summary Reviewer 2
A 52-year-old female enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 7/7/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees colonic Crohns disease. The physician reviewer found the Prometheus Anser IFX diagnostic testing performed on 7/7/14 was not likely to be more effective for this patient than other available treatment options. Menting and colleagues noted that patients with no [antidrug antibody] ADA formation in the first 24 weeks of treatment have little chance of it in the following 24 weeks. The presence of ADA is strongly correlated with adalimumab concentration. In this case, there is documentation of benefit from her use of adalimumab. In such a scenario, the clinical utility is unclear for testing of adalimumab levels. As such, it cannot be concluded that the Prometheus Anser IFX testing was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy such as adjusting therapy based on available clinical data and observation. Based upon the information set forth above, the testing 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 19-year-old male enrollee has requested reimbursement for behavioral health services from 3/01/17 through 3/10/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
The patient had an unclear risk of withdrawal. There were no medical conditions/complications reported. His emotional/behavioral/cognitive conditions/complications included comorbid anxiety and attention deficit/hyperactivity disorder. Per the records, he was only in the contemplation phase, thus requiring a structured program. The patient had a high likelihood of relapse, given his admission to his parents that he desired to continue substance use as well as his failed urine drug test in March 2018. The patient was unable to engage with his parents in a way that would allow his environment to be supportive.
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Overturned
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Medical Necessity
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Summary Reviewer
A 19-year-old male enrollee has requested reimbursement for behavioral health services from 3/01/17 through 3/10/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the American Psychiatric Association treatment guidelines for substance use disorders note that intensive outpatient program level of care can be used as step-down programs for individuals leaving hospital or residential settings who are at a high risk of relapsingto stabilize patients by retaining them in treatment and providing more extended intensive outpatient monitoring of relapse potential and co-occurring disorders. In this patients case, the six dimensions for American Society of Addiction Medicine Level 2.1 (intensive outpatient program) are met. The patient had an unclear risk of withdrawal. There were no medical conditions/complications reported. His emotional/behavioral/cognitive conditions/complications included comorbid anxiety and attention deficit/hyperactivity disorder. Per the records, he was only in the contemplation phase, thus requiring a structured program. The patient had a high likelihood of relapse, given his admission to his parents that he desired to continue substance use as well as his failed urine drug test in March 2018. The patient was unable to engage with his parents in a way that would allow his environment to be supportive. Intensive outpatient program level of care was in accordance with generally accepted standards of medical practice. Therefore, behavioral health intensive outpatient services from 3/01/17 through 3/10/18 were medically necessary for the treatment of this patient.
| 1 |
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.
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Overturned
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Experimental
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Summary Reviewer 1
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 the U.S. Food
and Drug Administration (FDA) approves the use of the Intracept Intraosseous Nerve Ablation
System in conjunction with radiofrequency generators for the ablation of basivertebral nerves of
the L3 through S1 vertebrae for the relief of chronic low back pain that has not responded to at
least six months of conservative care, and is also accompanied by features consistent with Type
1 or Type 2 Modic changes on magnetic resonance imaging (MRI), such as inflammation, edema,
vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues
within the adjacent marrow, hypointensive signals, and changes to the vertebral body marrow
including replacement of normal bone marrow by fat, and hyperintensive signals. Conger and
colleagues report, There is moderate-quality evidence that suggests this procedure is effective
in reducing pain and disability in patients with chronic low back pain who are selected based on
type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published
literature to date. Success of the procedure appears to be dependent on effective targeting of
the basivertebral nerve ablation. Non-industry funded high-quality, large prospective studies are
needed to confirm these findings. DeVivo and colleagues conclude, Percutaneous computed
tomography (CT)-guided intraosseous basivertebral nerve ablation seems to be a safe, fast, and
powerful technique for pain relief in patients with vertebrogenic chronic lower back pain, when
the selection of patients is based on a multidisciplinary approach including both conventional
diagnostic radiology and nuclear medicine imaging. Fischgrund and colleagues noted, Patients
treated with radiofrequency ablation of the basivertebral nerve ablation for chronic low back
pain exhibited significantly greater improvement in Oswestry Disability Index at three months
and a higher responder rate than sham treated controls. Basivertebral nerve ablation represents
a potential minimally invasive treatment for the relief of chronic low back pain. Michalik and
colleagues report, Basivertebral nerve radiofrequency ablation appears to be an effective
treatment for a subset of patients with chronic low back pain and evidence of Modic change
types 1 and 2 in the L3 to S1 vertebral body endplates who have failed to respond to conservative
treatment. However, all studies performed to date have been industry sponsored, and future
non-industry-funded trials will be needed to confirm these results. Tieppo Francio and Sayed
noted, Finding the source of chronic axial low back pain is clinically challenging, and often 80%
of diagnoses are described as non-specific low back pain, and in only 20% of cases, an anatomical
source can be attributed. Perhaps it is due to this variability and uncertainty that many
interventions for the treatment of chronic axial low back pain directly targeting anatomical
structures, such as intervertebral discs, muscles, facet joints, and ligaments, have limited success
rates and variable outcomes in the general population. Several studies have reported a high
incidence of vertebral endplate damage in up to 43% of subjects suffering from chronic axial low
back pain symptoms. These tend to manifest differently than when the etiology is from other
structures. Often, vertebral endplate pain patients tend to present with significant functional impairment and debilitating pain while seated, standing, or during spinal flexion (in contrast to
extension), with the pain reported as a burning, deep and achy, located in the midline region of
the lumbar spine without radicular symptoms, and without motor weakness, numbness or
tingling. In fact, vertebral pain from damaged endplates tends to present clinically different than
non-specific etiologies with reported greater frequency and longer duration of painful episodes
and worse outcomes with conservative treatment and surgery. In this case, the patient
presented to his provider on 1/26/22 with low back pain for over five years that had been
progressively worsening. The patient rated his pain at a current average of six out of ten, with
daily pain flares up rated at ten out of ten, particularly when getting out of bed. Pain is entirely
within his back without radiculopathy. The records noted that magnetic resonance imaging (MRI)
on 4/19/21 showed marked L3-L4 disc degeneration and endplate edema, Modic type I change,
and mild right L5 inferior endplate edema. However, the records did not include detailed
documentation regarding any objective examination findings to corroborate the pathology.
While the patient noted pain in the entirety of his back without radiculopathy, the absence of an
objective examination does not corroborate this, and there are multiple plausible pathologic
sources of significant pain generation. Overall, documentation is lacking regarding reasonably
detailed and/or evidenced findings supportive of the spinal vertebral bodies as being the
overwhelming primary generators of this patients chronic persistent pain. Therefore, thermal
destruction of intraosseous basivertebral nerve first two bodies, lumbar or sacral is not likely to
be more beneficial for treatment of the patients condition than any available standard therapy.
| 1 |
The patient is a 72-year-old male with a medical history of heart and kidney transplant. He presented to the emergency department with complaints of worsening cough for three weeks with shortness of breath and headache. He was admitted on 1/26/17 to an acute inpatient level of care. He was treated for acute on chronic diastolic dysfunction and chronic eosinophilic pneumonia with empiric antibiotics. His symptoms improved, and he remained stable. He developed headache with associated scalp pain. The etiology of the pain was unclear, as the patient had a complex wound on the scalp associated with squamous cell cancer. Eventually, he developed an associated rash and was treated effectively for a Zoster infection with intravenous acyclovir from 2/02/17 through 2/06/17. On 2/06/17, the documentation notes that the lesions were crusted, intravenous (IV) acyclovir was discontinued, and the patient was started on oral Valtrex for seven additional days. On 2/07/17, the patient was discharged in stable condition to a skilled nursing facility for further care. The Health Insurer has denied reimbursement for inpatient hospital services provided from dates of services 2/05/17 through 2/07/17. Per the Health Insurer, the services at issue were not medically
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 72-year-old male with a medical history of heart and kidney transplant. He presented to the emergency department with complaints of worsening cough for three weeks with shortness of breath and headache. He was admitted on 1/26/17 to an acute inpatient level of care. He was treated for acute on chronic diastolic dysfunction and chronic eosinophilic pneumonia with empiric antibiotics. His symptoms improved, and he remained stable. He developed headache with associated scalp pain. The etiology of the pain was unclear, as the patient had a complex wound on the scalp associated with squamous cell cancer. Eventually, he developed an associated rash and was treated effectively for a Zoster infection with intravenous acyclovir from 2/02/17 through 2/06/17. On 2/06/17, the documentation notes that the lesions were crusted, intravenous (IV) acyclovir was discontinued, and the patient was started on oral Valtrex for seven additional days. On 2/07/17, the patient was discharged in stable condition to a skilled nursing facility for further care. The Health Insurer has denied reimbursement for inpatient hospital services provided from dates of services 2/05/17 through 2/07/17. Per the Health Insurer, the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. Antiviral therapy has been shown to decrease progression and dissemination of acute herpes zoster in immunocompromised patients. Intravenous acyclovir remains the drug of choice for patients with evidence of disseminated disease or visceral organ involvement, ophthalmic involvement, advanced human immunodeficiency virus/acquired immune deficiency syndrome, and transplant recipients who have recently undergone transplantation or are being treated for rejection. This patient was admitted to the hospital from 1/26/17 through 2/07/17. He is considered immunocompromised due to taking medications for a heart transplant that are immunosuppressive. He was admitted due to a cough with chest pain and headache. He was started on IV acyclovir for a Zoster infection. He was tolerating this medication well, with slow improvement in pain and the rash. By 2/05/17, the patients pain was controlled with oral medication. There is no documentation that the patient had a fever or any intolerance to the medication. On 2/06/17, he continued to improve, the lesions were noted as being crusted over, and the treatment was changed to oral antiviral medications. In this case, the documentation does not support the continued need for acute inpatient hospitalization from 2/05/17 through 2/07/17. The patients pain was controlled. The eye specialist had determined that the infection did not involve the eye. The rash was improving, and there was no documentation demonstrating why he could not be transitioned to oral antiviral medication on 2/05/17 and discharged to a lower level of care. All told, inpatient hospital services provided from dates of services 2/05/17 through 2/07/17 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 61-year-old female diagnosed with ovarian cancer in 2008. She tested negative for BRCA mutations. She has been treated with surgery, Cisplatin, Taxol, Carboplatin, Avastin, Doxil, Gemzar, Topotecan and with olaparib and mTorC 1 and mTorC 2 inhibitor and participation in a clinical trial. A tissue sample from a chest wall metastasis was submitted for FoundationOne testing on 3/21/17. The results showed genomic alterations of PIK3CA, and TP53.
response to everolimus or temsirolimus. The patient has requested reimbursement for blood testing performed on 3/16/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational.
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Overturned
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Experimental
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Summary Reviewer 2
The patient is a 61-year-old female diagnosed with ovarian cancer in 2008. She tested negative for BRCA mutations. She has been treated with surgery, Cisplatin, Taxol, Carboplatin, Avastin, Doxil, Gemzar, Topotecan and with olaparib and mTorC 1 and mTorC 2 inhibitor and participation in a clinical trial. A tissue sample from a chest wall metastasis was submitted for FoundationOne testing on 3/21/17. The results showed genomic alterations of PIK3CA, and TP53. Neither of these suggests response to an approved treatment but the PIK3CA suggested possible response to everolimus or temsirolimus. The patient has requested reimbursement for blood testing performed on 3/16/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. FoundationOne tumor testing analyzes a tumor sample for genetic mutations that can help guide treatment options. The standard of care options for ovarian cancer include BRCA1 and BRCA2 testing. The National Comprehensive Cancer Network (NCCN) guidelines state that tumor molecular testing should be done. The recommended testing includes at least BRCA1 and BRCA2, homologous recombination pathway genes, and microsatellite instability (MSI) or DNA mismatch repair (MMR). Testing for BRCA 1 and BRCA 2 has been completed in 2015. Thus, testing for MSI or MMR and testing for homologous recombination pathway genes and for MSI or MMR was medically reasonable and more beneficial than other available standard testing. Given this support, the blood testing performed on 3/16/17 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old male enrollee has requested authorization and coverage for nerve stimulator implant. 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 an apnea-hypopnea index of 47. He is unable to tolerate continuous positive airway pressure (CPAP) therapy.
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Overturned
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Experimental
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Summary Reviewer 3
A 60-year-old male enrollee has requested authorization and coverage for nerve stimulator implant. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the medical evidence supports the requested services in this case. This patient has an apnea-hypopnea index of 47. He is unable to tolerate continuous positive airway pressure (CPAP) therapy. Clinical studies of the use of hypoglossal nerve stimulation suggest that patients with a body mass index less than 35 benefit from this device. Huntley and colleagues noted that the device may be used successfully in patients with body mass index greater than 32. Upper airway stimulation is a safe and effective therapy for patients with obstructive sleep apnea and represents a powerful option for its surgical treatment. Thus, the requested nerve stimulator implant is likely to be superior over other treatment options.
| 1 |
A 63-year-old female enrollee has requested reimbursement for intravitreal Eylea injections provided on 7/26/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 63-year-old female enrollee has requested reimbursement for intravitreal Eylea injections provided on 7/26/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that Choroidal neovascularization (CNV) is a common cause of vision loss in patients with pathologic myopia. It is thought to arise from thinning of the retina and choroid from axial elongation, leading to ischemia and expression of vascular endothelial growth factor (VEGF). Since the arrival of anti-VEGF agents, the standard of care for treatment of CNV has shifted from laser to these medications. The most commonly used anti-VEGF agents in the eye are bevacizumab, ranibizumab, and aflibercept. Both aflibercept and ranibizumab have been studied and shown to be effective in the treatment of myopic CNVM. The current medical evidence supports the services at issue in this clinical setting. Therefore, Eylea injections provided on 7/26/18 were medically necessary for the treatment of this patient.
| 0 |
The parent of an 11-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavioral analysis therapy from 7/18/18 forward (H0031, one hour per month, H0032, four hours per month, H2012, four hours per week school, H2012, two hours per week home, H2012, two hours per week parent training, H2019, four hours per week school board certified assistant behavior analyst (BCaBA), H2019, four hours per week home/community BCaBA, H2019, 12 hours per week school, and H2019, 20 hours per week home/community). The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism.
ABA provider has indicated that the patients problem behavior (i.e., aggression, tantrums) is reportedly
, two hours per week home, H2012, two hours per week parent training,
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of an 11-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavioral analysis therapy from 7/18/18 forward (H0031, one hour per month, H0032, four hours per month, H2012, four hours per week school, H2012, two hours per week home, H2012, two hours per week parent training, H2019, four hours per week school board certified assistant behavior analyst (BCaBA), H2019, four hours per week home/community BCaBA, H2019, 12 hours per week school, and H2019, 20 hours per week home/community). The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism. The physician reviewer found that the submitted documentation supports the medical necessity of a portion of the services at issue. The ABA provider has indicated that the patients problem behavior (i.e., aggression, tantrums) is reportedly occurring at home, in the community, and at school. However, there is a lack of data on the severity of problem behavior at school, just anecdotal reports. Before approval of the codes H2019 and H2012 in school, it is important to first evaluate the need for these services. The BACB Autism Practice Guidelines indicate that treatment should be dictated by assessment which, in turn, informs treatment intensity. Per the medical evidence, ABA is the most evidence based treatment for children on the autism spectrum. Based on the records, H0031, one hour per month, H0032, four hours per month, H2012, two hours per week home, H2012, two hours per week parent training, H2019, four hours per week home/community BCaBA and H2019, 20 hours per week home/community are medically necessary for the treatment of this patient. However, the submitted documentation fails to demonstrate the medical necessity of H2012, four hours per week school, H2019, four hours per week school BCaBA, and H2019, 12 hours per week school. Therefore, a portion of the services at issue was and is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
| 1 |
A 31-year-old female enrollee has requested reimbursement for evaluation of arterial inflow and
venous outflow of abdomen, retroperitoneum, scrotal contents and/or pelvic organs and
detailed fetal ultrasound, fetal doppler echocardiography and umbilical artery doppler
velocimetry on 3/11/22 and 5/10/22. The Health Insurer has denied this request and reported
that the services at issue were investigational for the evaluation of the enrollees high risk
pregnancy.
and at 21.2 weeks of gestation. The
patient had chronic hypertension that was well-controlled and gestational diabetes.
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Upheld
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Experimental
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Summary Reviewer 1
A 31-year-old female enrollee has requested reimbursement for evaluation of arterial inflow and
venous outflow of abdomen, retroperitoneum, scrotal contents and/or pelvic organs and
detailed fetal ultrasound, fetal doppler echocardiography and umbilical artery doppler
velocimetry on 3/11/22 and 5/10/22. The Health Insurer has denied this request and reported
that the services at issue were investigational for the evaluation of the enrollees high risk
pregnancy. The physician reviewer found that Doppler ultrasonography is a noninvasive
technique used to assess the hemodynamic components of vascular resistance in pregnancies
complicated by fetal growth restriction. There is currently a lack of evidence that umbilical artery
Doppler velocimetry provides information about fetal well-being in fetuses with normal growth.
In this case, the records did not demonstrate that the patients pregnancy was complicated by
fetal growth restriction. Both theoretic models and large clinical studies suggest that initiating
antepartum fetal testing at 32 weeks of gestation or later is appropriate for most at-risk patients.
In this case, the dates of service at issue were at 12.5 weeks and at 21.2 weeks of gestation. The
patient had chronic hypertension that was well-controlled and gestational diabetes. For patients
with hypertension that is well-controlled on medication, as in this case, standard therapy based
on American College of Obstetricians and Gynecologists (ACOG) guidelines is weekly testing
beginning at 32 weeks gestation with nonstress tests and a biophysical profile. For patients with
gestational diabetes, a single third-trimester ultrasound examination at 36 to 39 weeks to
estimate fetal weight, regardless of degree of metabolic control or requirement for insulin or oral
antihyperglycemic medications, is recommended. While a Doppler ultrasound may be indicated
in the case of intrauterine growth restriction (IUGR), the records did not document that this was
the case in this patient. Therefore, evaluation of arterial inflow and venous outflow of abdomen,
retroperitoneum, scrotal contents and/or pelvic organs and detailed fetal ultrasound, fetal
doppler echocardiography and umbilical artery doppler velocimetry on 3/11/22 and 5/10/22 was
not likely to have been more beneficial for evaluation of the patients condition than any available
standard therapy.
| 1 |
A 34-year-old female enrollee has requested reimbursement for partial hospitalization program level of care provided on 1/08/16, 11/11/16, 1/12/16, 1/15/16, 1/18/16, 1/19/16, 1/20/16, 1/21/16, 1/22/16, 1/25/16, 1/26/16, 1/27/16, 1/28/16, 1/29/16, 2/01/16, 2/02/16, 2/03/16, 2/04/16, 2/05/16, 2/08/16, 2/10/16, 2/11/16, 2/12/16, 2/15/16, 2/16/16, 2/17/16, 2/18/16, 2/19/16 and
on 2/24/16, 2/26/16, 2/29/16, 3/01/16, 3/02/16, 3/03/16, 3/04/16, 3/07/16, 3/08/16, 3/09/16, 3/10/16, 3/11/16, 3/17/16, 3/18/16, 3/21/16, 3/24/16, 3/25/16, 3/28/16, 3/29/16, 3/30/16 and 3/31/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
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Overturned
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Medical Necessity
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Summary Reviewer
A 34-year-old female enrollee has requested reimbursement for partial hospitalization program level of care provided on 1/08/16, 11/11/16, 1/12/16, 1/15/16, 1/18/16, 1/19/16, 1/20/16, 1/21/16, 1/22/16, 1/25/16, 1/26/16, 1/27/16, 1/28/16, 1/29/16, 2/01/16, 2/02/16, 2/03/16, 2/04/16, 2/05/16, 2/08/16, 2/10/16, 2/11/16, 2/12/16, 2/15/16, 2/16/16, 2/17/16, 2/18/16, 2/19/16 and inpatient outpatient treatment provided on 2/24/16, 2/26/16, 2/29/16, 3/01/16, 3/02/16, 3/03/16, 3/04/16, 3/07/16, 3/08/16, 3/09/16, 3/10/16, 3/11/16, 3/17/16, 3/18/16, 3/21/16, 3/24/16, 3/25/16, 3/28/16, 3/29/16, 3/30/16 and 3/31/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that patients require safe and stable living environments in order to develop their recovery skills. The submitted records support the services at issue in this patients case. The six ASAM dimensions for partial hospitalization program level of care were met. There was a minimal risk of severe withdrawal, although she had to have detoxification prior to the disputed timeframe. She had no medical conditions/complications. Her emotional/behavioral/cognitive conditions/complications included a moderately severe mixed manic-depressive state. The patient was somewhat motivated to change, although she required structure of a day program at least to engage and get her on track. She had a high likelihood of relapse without close monitoring and support, given her relapse during the program. The records documented a minimally supportive environment. Given the severity of the patients illness, partial hospitalization program level of care and stepdown to intensive outpatient program treatment were in accordance with generally accepted standards of medical practice. Therefore, partial hospitalization program level of care provided on 1/08/16, 11/11/16, 1/12/16, 1/15/16, 1/18/16, 1/19/16, 1/20/16, 1/21/16, 1/22/16, 1/25/16, 1/26/16, 1/27/16, 1/28/16, 1/29/16, 2/01/16, 2/02/16, 2/03/16, 2/04/16, 2/05/16, 2/08/16, 2/10/16, 2/11/16, 2/12/16, 2/15/16, 2/16/16, 2/17/16, 2/18/16 and 2/19/16 and intensive outpatient treatment provided on 2/24/16, 2/26/16, 2/29/16, 3/01/16, 3/02/16, 3/03/16, 3/04/16, 3/07/16, 3/08/16, 3/09/16, 3/10/16, 3/11/16, 3/17/16, 3/18/16, 3/21/16, 3/24/16, 3/25/16, 3/28/16, 3/29/16, 3/30/16 and 3/31/16 were medically necessary for the treatment of this patient.
| 1 |
patient is 63-year-old male who presented to the emergency room on 7/22/22. The patient
reported a posterior headache associated with dizziness and lightheadedness. The patient has
requested reimbursement for an emergency room claim for 7/22/22 through 7/23/22. The Health
Insurer has denied this request and reported that the services at issue were not medically necessary
for the treatment of this patient.
In this case, the patient reported dizziness and had
abnormal heel-to-toe tandem walking.
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Upheld
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Medical Necessity
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Summary Reviewer
This patient is 63-year-old male who presented to the emergency room on 7/22/22. The patient
reported a posterior headache associated with dizziness and lightheadedness. The patient has
requested reimbursement for an emergency room claim for 7/22/22 through 7/23/22. The Health
Insurer has denied this request and reported that the services at issue were not medically necessary
for the treatment of this patient. This denial is the subject of this appeal and determination.
The physician reviewer found that the submitted documentation does not support the medical
necessity of the services at issue. Cerebellar, or posterior infarcts, are notoriously difficult to
diagnose without obtaining a brain MRI. In this case, the patient reported dizziness and had
abnormal heel-to-toe tandem walking. As a hemorrhagic stroke was ruled out, a brain MRI was
necessary. Given that a brain MRI could have been obtained from the emergency department or at
a lower level of care, such as observation level of service, the service at issue was not medically
indicated. Therefore, the emergency room claim for 7/22/22 through 7/23/22 was not medically
necessary for the treatment of this patient.
| 1 |
A 45-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Gamunex-C from 7/01/21 forward. The Health Insurer has denied this request and reported that the medication at issue was and is investigational for the treatment of the enrolleeas medical condition.
small fiber polyneuropathy (SFPN) attributed to autoimmunity received IVIG for more than three months.
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Overturned
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Experimental
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Summary Reviewer 1
A 45-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Gamunex-C from 7/01/21 forward. The Health Insurer has denied this request and reported that the medication at issue was and is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that standard treatment of small fiber neuropathy is dependent on the underlying etiology as well as treatment of associated neuropathic pain, which can include several different classes of medications. In small fiber neuropathy, current neuropathic pain treatment options are generally insufficient to relieve the pain substantially. Small fiber polyneuropathy has various underlying causes, including associations with systemic autoimmune conditions. Intravenous immunoglobulin (IVIG) is a first-line treatment for immune-mediated neuropathies such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy.
In a retrospective study by Liu and colleagues, 55 patients with objectively confirmed small fiber polyneuropathy (SFPN) attributed to autoimmunity received IVIG for more than three months. The proportion of autonomic function tests (AFT) interpreted as indicating SFPN dropped from 89% at baseline to 55%. Sweat production normalized, and the other four domains all trended toward improvement. Overall, 74% of patients rated themselves aimproveda, and their neurologists labeled 77% as aIVIG respondersa. The authors concluded that the results provide Class IV evidence suggesting that IVIG is safe and effective for rigorously selected SFPN patients with apparent autoimmune causality.
A review article by Oaklander reviewed various studies regarding immunotherapy for distal SFPN. The authors noted, aThese reports also provide a rationale for treating carefully selected patients with immunomodulatory therapies. Candidates should have symptoms consistent with SFPN, objective confirmation of diagnosis, exclusion of other causes, failure to improve with symptom management, and, ideally, serologic markers of immunity/inflammation.a In this case, the patient has small fiber polyneuropathy and an autoimmune condition. Her clinical symptoms have improved with the use of IVIG. Based on the studies noted above, patients with autoimmune small fiber neuropathy may improve clinically with IVIG. Therefore, Gamunex-C from 7/01/21 forward was and is likely to be more beneficial for the treatment of this patient than any available standard therapy.
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A 46-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee's hepatitis C virus.
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Overturned
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Medical Necessity
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Summary Reviewer
A 46-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee's hepatitis C virus. The physician reviewer found the proposed treatment is medically necessary and is considered the standard of care for the treatment of the patients with hepatitis C virus genotype 1a. Per the American Association for the Study of Liver Diseases/Infectious Disease Society of America (AASLD/IDSA) guidelines, all patients with chronic active HCV are eligible for treatment and should be treated with U.S. Food and Drug Administration (FDA) approved antiviral therapy regardless of fibrosis score. Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. The evidence supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to nonliver-related comorbid conditions. The goal of treatment of HCV-infected persons is to reduce mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma, by the achievement of virologic cure. Any decision to defer or delay treatment runs the risk of allowing a subset of patients to progress to cirrhosis and thereby increase their future risk of hepatic decompensation or hepatocellular carcinoma. As such, the requested Harvoni is medically necessary for treatment of the patients hepatitis C virus. For the reasons stated above, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 42-year-old female enrollee has requested reimbursement for gene test FoundationOne (procedure codes 81201, 81210, 81211, 81235, 81270, 81275, 81292, 81295, 81298 and 81321) on 4/6/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic breast cancer to the liver and bones.
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Upheld
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Experimental
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Summary Reviewer 1
A 42-year-old female enrollee has requested reimbursement for gene test FoundationOne (procedure codes 81201, 81210, 81211, 81235, 81270, 81275, 81292, 81295, 81298 and 81321) on 4/6/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic breast cancer to the liver and bones. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. FoundationOne is a molecular assay that explores the mutations of an individuals cancer cells. The hope is that the assay will identify a specific mutation or target, which could inform the clinician as to which chemotherapeutic drug would be useful. However, there is no convincing evidence that the assay adds to the decision-making ability of the clinician, nor yields a result that is reliably clinically beneficial. There are various non-randomized studies exploring the value of molecular profiling but these studies are not convincing. A recent randomized study by Le Tourneau and colleagues did not demonstrate significant clinical benefit from choosing therapy based on molecular targets. All told, gene test FoundationOne (procedure codes 81201, 81210, 81211, 81235, 81270, 81275, 81292, 81295, 81298 and 81321) performed on 4/6/16 was not likely to have been more efficacious than other methods of evaluating this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 40-year-old female enrollee has requested reimbursement for Anser ADA diagnostic testing performed on 2/18/15. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition.
. In this case, the Anser ADA testing was ordered to determine the etiology for possible loss of response to Humira and to direct the management of the patients Crohns disease. The test revealed a lack of antibodies and that the drug was present.
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Overturned
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Experimental
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Summary Reviewer 2
A 40-year-old female enrollee has requested reimbursement for Anser ADA diagnostic testing performed on 2/18/15. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition. The physician reviewer found that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. In this case, the Anser ADA testing was ordered to determine the etiology for possible loss of response to Humira and to direct the management of the patients Crohns disease. The test revealed a lack of antibodies and that the drug was present. The use of Anser ADA has not been clinically proven to improve patient clinical outcomes, and has not definitively demonstrated clinical utility. Moreover, the effectiveness of Anser ADA compared with conventional courses of action remains unproven. Patients being treated with adalimumab may experience loss of response. However, loss of response can be due to multiple factors, and the appropriate method for determination of the cause for loss of response is not clear. Given the lack of supporting demonstrating definitive utility, the ADA diagnostic testing performed on 2/18/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 28-year-old male who is requesting reimbursement for Level 3.5 substance abuse residential treatment. The records document opioid use disorder complicated by recent arm and leg fractures.
, the patient underwent prior withdrawal management for opioid withdrawal and had Suboxone dosage adjusted throughout his treatment stay.
In terms of dimension 2, biomedical conditions, the patient had recent orthopedic surgeries for multiple fractures.
, the patient has been diagnosed with major depressive disorder and generalized anxiety disorder. He has been using 1 g of fentanyl on a daily basis. He had attempted treatment in various levels of care since April 2021 and either left against medical advice or relapsed during the programs. He ultimately used fentanyl at a facility and then left against medical advice with another resident and fell off a wall, which resulted in significant orthopedic injuries.
participation in treatment in the absence of 24-hour support and structure of a Level 3.5 program.a
In terms of
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 28-year-old male who is requesting reimbursement for Level 3.5 substance abuse residential treatment. The records document opioid use disorder complicated by recent arm and leg fractures. The physician reviewer found that based on the records, this patient met American Society of Addiction Medicine (ASAM) Level 3.5 criteria for RTC services (ASAM 3.5) provided from 8/19/21 through 9/13/21. The ASAM criteria focuses on six dimensions to determine the appropriate level of care.
In terms of dimension 1, acute intoxication or withdrawal potential, the patient underwent prior withdrawal management for opioid withdrawal and had Suboxone dosage adjusted throughout his treatment stay. The patient meets the sub-criteria of awithdrawal needs can be met in Level 3.5 setting.a
In terms of dimension 2, biomedical conditions, the patient had recent orthopedic surgeries for multiple fractures. The patient meets sub-criteria of abiomedical problems, if any, are stable.a
In terms of dimension 3, emotional, behavioral, or cognitive conditions, the patient has been diagnosed with major depressive disorder and generalized anxiety disorder. He has been using 1 g of fentanyl on a daily basis. He had attempted treatment in various levels of care since April 2021 and either left against medical advice or relapsed during the programs. He ultimately used fentanyl at a facility and then left against medical advice with another resident and fell off a wall, which resulted in significant orthopedic injuries. The patient meets sub-criteria of amental status permits participation,a and apatient demonstrated repeated inability to control his impulses to use alcohol and other drugs or to engage in antisocial behavior and is in imminent danger of relapse with attendant likelihood of harm to self. The resulting level of dysfunction is of such severity that it precludes participation in treatment in the absence of 24-hour support and structure of a Level 3.5 program.a
In terms of dimension 4, readiness to change, the patient was admitted voluntarily for treatment after his medical admission for surgery to repair orthopedic injuries sustained while relapsing at a treatment facility and falling off a wall. He has been using opiates problematically for several years. The patient had tried short-term detox with partial hospitalization program and intensive outpatient programs on multiple occasions since April 2021 and relapsed during the programs. The patient meets sub-criteria of arequires structured therapy and a 24-hour programmatic milieu to promote treatment progress and recovery because motivational interventions have not succeeded at less intensive levels of care and such interventions are assessed as not likely to succeed at a less intensive level of care.a
In terms of dimension 5, relapse, continued use, continued problem potential, this patient has a history of multiple relapses with multiple attempts at treatment. He was managed with Suboxone during the residential treatment period. The patient meets sub-criteria of "patient is experiencing addiction symptoms such as drug cravingaThis situation poses an imminent danger of harm to self or others in the absence of 24-hour monitoring and structured support. The introduction of psychopharmacologic support is indicated to decrease addictive symptoms, such as cravings, that will enable the patient to delay immediate gratification and reinforce positive recovery behaviors.a
In terms of dimension 6, recovery environment, he has not been able to cope without using substances outside of facilities since his last relapse, which appears to be at least one year ago. He has been actively participating in treatment program since April 2021 and relapsed either during treatment or left against medical advice. He has been unable to work due to his addiction. He has been in a relapse for months when in the home environment. The patient meets sub-criteria of apatient is unable to cope, for even limited periods of time, outside of 24-hour care. He needs staff monitoring to learn to cope with Dimension 6 problems before being transferred safely to a less intensive setting.a
Therefore, the patient meets ASAM criteria for inpatient residential treatment center services (ASAM 3.5) provided from 8/19/21 through 9/13/21. Therefore, inpatient residential treatment center services (ASAM 3.5) provided from 8/19/21 through 9/13/21 were medically necessary for the treatment of this patient.
| 1 |
The parent of a 13-year-old female enrollee has requested reimbursement for residential mental health treatment provided from 1/31/19 through 3/04/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
. The medical records indicate that the patient was not actively suicidal. She did not engage in self-harm behaviors but did have a reported history of passive suicidal ideation.
The patient has had issues with level of function due to mental illness in the past and relationship problems, but overall showed appropriate daily functioning while in treatment, including intact activities of
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 13-year-old female enrollee has requested reimbursement for residential mental health treatment provided from 1/31/19 through 3/04/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. 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 2. The medical records indicate that the patient was not actively suicidal. She did not engage in self-harm behaviors but did have a reported history of passive suicidal ideation. With regards to functional status, the records support a score of 3. The patient has had issues with level of function due to mental illness in the past and relationship problems, but overall showed appropriate daily functioning while in treatment, including intact activities of daily living. In terms of comorbidity, the records support a score of 1. The patient did not have active medical problems or substance use that affected her primary psychiatric issues. With regards to level of stress of the recovery environment, the records support a score of 2. There is 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 did not attempt any forms of the intensive treatment on an outpatient basis. In terms of acceptance and engagement of the patient, the records support a score of 2 to 3. The patient was hesitant to participate in treatment after admission to the residential treatment program. There was no indication that she was not participating in her outpatient treatment prior to the residential treatment center admission. With regards to acceptance and engagement of the parent, the records support a score of 2. The parent worked actively and constructively with clinicians on a regular basis. Thus, the patient has a composite score of 17 to 18. This score correlates intensive outpatient services. Therefore, residential mental health treatment provided from 1/31/19 through 3/04/19 was not medically necessary for the treatment of this patient.
| 1 |
A 38-year-old male enrollee has requested reimbursement for polymerase chain reaction testing for gastrointestinal pathogen panel performed on 12/16/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 38-year-old male enrollee has requested reimbursement for polymerase chain reaction testing for gastrointestinal pathogen panel performed on 12/16/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the use of the gastrointestinal pathogen panel test is not supported in this case. The test is used to diagnose diarrhea, and there are several pathogens that can cause diarrhea. The American Academy of Family Practice guidelines for evaluation of acute diarrhea do not recommend the use of polymerase chain reaction assays at this time. Guidelines for the evaluation of diarrhea do not recommend nucleic acid panels in most cases either, and Riddle and colleagues stated, aIn addition, the significance of an identified organism may not be clear as these molecular technologies, which involve nucleic acid amplification, are limited to our existing knowledge of a microbesa genome and do not discriminate between viable and non-viable organisms. As a result, they can detect microbes at nonpathogenic levels. Given the high rates of asymptomatic carriage of enteropathogens, this can be a considerable problem. To confound matters, further multiplex techniques are more commonly associated with increased detection of mixed infections and the relative importance of each pathogen may be unclear.a Guidelines from the Infectious Diseases Society of America do not recommend the gastrointestinal pathogen panel in cases of diarrhea without severe diarrhea characterized by complications such as fever or hematochezia. Therefore, polymerase chain reaction testing for gastrointestinal pathogen panel performed on 12/16/19 was not likely to have been more beneficial than other available methods of evaluating this patient.
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An 18-year-old male enrollee has requested reimbursement for substance use residential treatment from 5/16/15 through 6/29/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
Upon admission, the patient was engaging and motivated for treatment with a strong desire to succeed. He reported no history of withdrawal symptoms. He had no acute psychiatric comorbidity or unresolved medical issues.
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Upheld
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Medical Necessity
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Summary Reviewer
An 18-year-old male enrollee has requested reimbursement for substance use residential treatment from 5/16/15 through 6/29/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. The records failed to demonstrate that less restrictive interventions targeting the patients substance use during the episode of illness had either been unsuccessful or would have more than likely been inappropriate. Upon admission, the patient was engaging and motivated for treatment with a strong desire to succeed. He reported no history of withdrawal symptoms. He had no acute psychiatric comorbidity or unresolved medical issues. Although many of his decisions were self-defeating, he did not pose an imminent threat to self or others. Prior to admission, the patient was engaged in neither specialty treatment services nor community programming. He had not pursued trusted treatment interventions for cannabis use disorder that can be safely and effectively delivered in the outpatient setting, such as motivational enhancement therapy, cognitive behavioral therapy, twelve-step facilitation, contingency management or family therapy, which was identified at presentation as an intervention of critical importance in this particular case. In sum, there was no evidence to suggest that comprehensive specialty services provided at a lower level of care, such as partial hospitalization or intensive outpatient programming either at home or in a sober living environment would have been unreasonable or consistent with inadequate care. Thus, substance use residential treatment from 5/16/15 through 6/29/15 was not medically indicted 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 20-year-old male enrollee has requested reimbursement for the Anser IFX testing provided on 10/26/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease status post resection.
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Upheld
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Experimental
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Summary Reviewer 1
A 20-year-old male enrollee has requested reimbursement for the Anser IFX testing provided on 10/26/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease status post resection. The physician reviewer found that some evidence exists to suggest 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. However, the reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, there are few well controlled clinical trials to confirm that use of the Anser IFX testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment (Steenholdt, et al; Nanda, et al). All told, the Anser IFX testing provided on 10/26/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 52-year-old male enrollee has requested reimbursement and prospective authorization and coverage for elotuzumab (Empliciti) from 1/4/17 through 7/3/17. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees myeloma.
. This patient received Empliciti as part of a clinical trial.
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Overturned
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Experimental
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Summary Reviewer 2
A 52-year-old male enrollee has requested reimbursement and prospective authorization and coverage for elotuzumab (Empliciti) from 1/4/17 through 7/3/17. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees myeloma. The physician reviewer found that Empliciti is a humanized monoclonal antibody against SLAMF7, which is expressed on most myeloma cells. Empliciti was approved by the U.S. Food and Drug Administration (FDA) in 2015 for use in patients with relapsed and refractory myeloma in combination with lenalidomide and dexamethasone. This patient received Empliciti as part of a clinical trial. At the time of this patients enrollment, there was already compelling data on the efficacy of Empliciti in patients with myeloma (Lonial; et al; Zonder, et al). Given this support, the requested treatment with Empliciti from 1/4/17 through 7/3/17 was and 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 medication at issue was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old male enrollee has requested reimbursement for Oncotype DX Genomic Prostate Score performed on 5/16/19. 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.
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Overturned
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Medical Necessity
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Summary Reviewer
A 60-year-old male enrollee has requested reimbursement for Oncotype DX Genomic Prostate Score performed on 5/16/19. 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 (NCCN) recommends that men who are status post biopsy with low or favorable intermediate risk disease may consider the use of the Oncotype DX testing. Retrospective studies have shown that molecular assays performed on prostate biopsy or radical prostatectomy specimens provide prognostic information independent of NCCN risk groups. These include, but are not limited to, likelihood of biochemical progression after radical prostatectomy or external beam therapy, and likelihood of developing metastasis after radical prostatectomy or salvage radiotherapy. Men with clinically localized disease may consider the use of tumor-based molecular assays. It is considered a standard of care in guiding treatment decision making. Therefore, the Oncotype DX Genomic Prostate Score performed on 5/16/19 was medically necessary for the evaluation of this patient.
| 1 |
The parent of a 12-year-old male enrollee has requested reimbursement and prospective authorization and coverage for intravenous immune globulin therapy. The Health Insurer has denied this request indicating that the services at issue were and are investigational for the treatment of the enrollees medical condition.
. The patient has been treated with IVIG with associated improvement in symptoms. A medical review of IVIG and encephalitis revealed use of immunoglobulins and
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a 12-year-old male enrollee has requested reimbursement and prospective authorization and coverage for intravenous immune globulin therapy. The Health Insurer has denied this request indicating that the services at issue were and are investigational for the treatment of the enrollees medical condition. The physician reviewer found in this clinical setting, there is support for IVIG in treatment of this patients medical condition. The patient has been treated with IVIG with associated improvement in symptoms. A medical review of IVIG and encephalitis revealed use of immunoglobulins and plasmapheresis as alternatives to steroids for Hashimotos encephalopathy in a case series (Yu et al). IVIG has seen associated with improvement in children with acute encephalitis syndrome complicated by myocarditis (Bhatt et al). In a recently published review of autoimmune encephalitis, it was stated that the repertoire of autoimmune encephalitis in children is different from that of adults. The younger the child the more difficult it is to recognize specific autoimmune encephalitis syndrome, which suggests that guidelines for pediatric autoimmune encephalitis will be more dependent on antibody and other ancillary tests than the syndrome-based guidelines in this Position Paper (Graus et al). In a study of acute immune-mediated and infectious encephalitis in 28 children, immune-modulating therapies were given to 28 patients. The authors wrote that although evidence is limited to retrospective series and case reports, the best available data suggests that early treatment with intravenous immunoglobulin or plasmapheresis, or both, followed by long-term immunosuppression is associated with better outcomes. A study regarding off-label medication use in 677 children admitted to an academic pediatric critical care unit published that FDA-prescribing guidelines were available in less than 35% of the commonly prescribed medications (Hsu and Brazelton). Given the above-referenced medical literature, IVIG was and is likely to be more efficacious for treatment of the patients autoimmune encephalitis symptoms than any available standard therapy. Therefore, the services at issue were and are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 41-year-old male enrollee has requested reimbursement for transcranial magnetic stimulation (TMS) provided from 10/02/20 through 11/20/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 41-year-old male enrollee has requested reimbursement for transcranial magnetic stimulation (TMS) provided from 10/02/20 through 11/20/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that depression is a common mental disorder and a leading cause of morbidity. Approximately 30% of patients do not respond to standard medication and/or psychotherapy. The evidence on repetitive TMS (rTMS) for depression is adequate, although the clinical response can be variable. The majority of patients who achieve remission following rTMS continue to stay in remission at the end of one year. Perera and colleagues noted, aTMS therapy is recommended for use as a subsequent option in patients who previously benefited from an acute treatment course and are experiencing a recurrence of their illness (continuation or maintenance).a This consensus statement also recommended that aTMS can be reintroduced in patients who are relapsing into depression after initially responding to TMS treatment.a Given that the patientas depressive symptoms improved by over 50% during this course of TMS, the records document that the requested treatment is superior to the standard of care, which the patient has previously tried and not responded to. Therefore, TMS provided from 10/02/20 through 11/20/20 was likely to have been more beneficial than other available standard therapy.
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A 58-year-old female enrollee has requested authorization and coverage for an electric hospital bed (E0265). The Health Insurer has denied this request indicating that the requested equipment is not medically necessary for treatment of the enrollee, who has been diagnosed with muscle weakness and reduced mobility.
that the patient has a history of alcohol abuse and liver cirrhosis, conditions associated with encephalopathy due to multiple mechanisms of action. The patient also had muscle weakness and significant mobility impairments. She was requiring total assistance for transfers by mechanical lift transfer device. She had positioning needs due to her respiratory condition, gastrostomy tube feeds, pressure injury and susceptibility for skin and soft tissue breakdown.
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Upheld
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Medical Necessity
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Summary Reviewer
A 58-year-old female enrollee has requested authorization and coverage for an electric hospital bed (E0265). The Health Insurer has denied this request indicating that the requested equipment is not medically necessary for treatment of the enrollee, who has been diagnosed with muscle weakness and reduced mobility. The physician reviewer found that the patient has a history of alcohol abuse and liver cirrhosis, conditions associated with encephalopathy due to multiple mechanisms of action. The patient also had muscle weakness and significant mobility impairments. She was requiring total assistance for transfers by mechanical lift transfer device. She had positioning needs due to her respiratory condition, gastrostomy tube feeds, pressure injury and susceptibility for skin and soft tissue breakdown. These mobility needs could have been met with a semi-electric hospital bed with an appropriate mattress surface. A total electric hospital bed also includes electric height adjustment, which could be necessary for individuals who require this feature for independent transfers into and out of the bed. In the current case, this feature was obviated by the patients use of a mechanical lift device for dependent transfers. Electric height adjustment on a hospital bed is otherwise considered a convenience feature. Thus, the requested electric hospital bed (E0265) is not medically necessary for the treatment of this patient. Therefore, the requested equipment is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 48-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 11/25/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for purposes of the enrollees breast cancer screening.
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Overturned
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Experimental
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Summary Reviewer 2
A 48-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 11/25/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for purposes of the enrollees breast cancer screening. The physician reviewer found 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. Medical studies and peer reviewed literature support the use of tomosynthesis in this clinical setting. For these reasons, the tomosynthesis used to screen this patient for breast cancer was likely to be more beneficial than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 63-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 3/08/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 63-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 3/08/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is unknown if the DecisionDx-Melanoma assay can be used to make clinical decisions. Thus, DecisionDx-Melanoma testing provided on 3/08/19 was not likely to have been more beneficial than any available standard therapy.
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The parent of a 10-year-old male enrollee has requested reimbursement and prospective authorization and coverage for intensive behavioral therapies (33 hours per week of H2019) provided from 1/03/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees autism.
The VB-MAPP report indicated that the patient was performing at the approximate level of an 18 to 30 month old. The records documented aggressive behavior, elopement, and pica/mouthing.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 10-year-old male enrollee has requested reimbursement and prospective authorization and coverage for intensive behavioral therapies (33 hours per week of H2019) provided from 1/03/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees autism. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The VB-MAPP report indicated that the patient was performing at the approximate level of an 18 to 30 month old. The records documented aggressive behavior, elopement, and pica/mouthing. While aggression is relatively low, elopement and pica/mouthing occurred more frequently and can be dangerous. It is important that the patient continue to receive ABA treatment to decrease the frequency of these behaviors and learn appropriate alternative/replacement behaviors. Further, the listed goals throughout the authorization plan highlight the need for a more intense level of service. In this patients case, the results of the VB-MAPP assessment, frequency of problem behavior, and barriers assessment supported 33 hours of CPT code H2019 per week. ABA therapy is the most evidence-based treatment for individuals on the autism spectrum. The medical evidence supports the services at issue in this clinical setting. Therefore, intensive behavioral therapies (33 hours per week of H2019) provided from 1/03/19 forward were and are medically necessary for the treatment of this patient.
| 1 |
The patient is a 53-year-old female. Magnetic resonance imaging (MRI) of the left shoulder dated
10/18/22 reported the following findings: moderate osteoarthritis changes at the glenohumeral
joint; small shoulder joint effusion; ill-defined intermediate proton density/T2 signal in the axillary
recess of the shoulder joint compatible with intra-articular debris versus synovitis; several sub-
centimeter hypointense loose bodies in the subscapularis recess; mild tendinosis of the
supraspinatus tendon on both superimposed small low-grade interstitial tears in the distal tendon
and bursal surface fraying of the tendon; mild tendinosis of the infraspinatus tendon although the
infraspinatus tendon is intact; degenerative tears in the superior, posterior-superior, anterior-
superior, and anterior-inferior labrum; mild tendinosis of the long head biceps tendon; minimal
degenerative change at the acromioclavicular joint; and mild posterior subluxation of the humeral
head relative to the glenoid, although no bone contusion, fracture, or dislocation was
.
The patient has requested authorization and coverage for arthroplasty, glenohumeral joint; total
shoulder [glenoid and proximal humeral replacement (example: total shoulder)]; left. The Health
Insurer has denied this request and reported that the requested service is not medically necessary
for the treatment of this patient.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 53-year-old female. Magnetic resonance imaging (MRI) of the left shoulder dated
10/18/22 reported the following findings: moderate osteoarthritis changes at the glenohumeral
joint; small shoulder joint effusion; ill-defined intermediate proton density/T2 signal in the axillary
recess of the shoulder joint compatible with intra-articular debris versus synovitis; several sub-
centimeter hypointense loose bodies in the subscapularis recess; mild tendinosis of the
supraspinatus tendon on both superimposed small low-grade interstitial tears in the distal tendon
and bursal surface fraying of the tendon; mild tendinosis of the infraspinatus tendon although the
infraspinatus tendon is intact; degenerative tears in the superior, posterior-superior, anterior-
superior, and anterior-inferior labrum; mild tendinosis of the long head biceps tendon; minimal
degenerative change at the acromioclavicular joint; and mild posterior subluxation of the humeral
head relative to the glenoid, although no bone contusion, fracture, or dislocation was identified.
The patient has requested authorization and coverage for arthroplasty, glenohumeral joint; total
shoulder [glenoid and proximal humeral replacement (example: total shoulder)]; left. 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 service. In a review of shoulder replacement for osteoarthritis, Pandya and colleagues
report, Initial treatment should be non-operative, such as activity modification, oral analgesics
(for example, nonsteroidal anti-inflammatories) and possibly physical therapy or corticosteroid
injections. Patients with ongoing severe pain and functional restriction despite non-operative
treatment would be candidates for surgery, usually a shoulder replacement. The most common
indication for total shoulder arthroplasty is osteoarthritis. In a systematic literature review and
meta-analysis of the impact of total shoulder arthroplasty in generic and shoulder-specific health-
related quality-of-life measures, Carter and colleagues conclude, Total shoulder arthroplasty
leads to significant improvements in scores for function and pain. Shoulder-specific measures of
function consistently showed the greatest degree of improvement, with large effect sizes. Total
shoulder arthroplasty also leads to significant improvements in overall physical well-being, with a
moderate-to-large effect size. In this case, the patient has a history of right total shoulder
arthroplasty and arthritis of the left shoulder. An examination of the left shoulder revealed a range
of motion of 150/85/30/L5, with strength noted as 5/5 with pain. The patient had tried and failed
medications and injections for the left shoulder, including PRP injections. An undated letter from
the patients physical therapist reported that physical therapy is not indicated for the left shoulder
prior to surgery. An MRI dated 10/18/22 showed moderate osteoarthritis changes at the
glenohumeral joint. In this case, given that the records demonstrate subjective and objective
deficits that are corroborated by imaging studies along with the trial and failure of conservative
treatment modalities, and as current medical literature supports the requested service as safe and
effective, the requested service is medically indicated. Therefore, arthroplasty, glenohumeral joint;
total shoulder [glenoid and proximal humeral replacement (example: total shoulder)]; left is
medically necessary for the treatment of this patient.
| 1 |
A 59-year-old male enrollee has requested authorization and coverage for deep brain stimulation.
The Health Insurer has denied this request and reported that the requested service is investigational
for the treatment of the enrollees Parkinsons disease.
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Overturned
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Experimental
|
Summary Reviewer 2
A 59-year-old male enrollee has requested authorization and coverage for deep brain stimulation.
The Health Insurer has denied this request and reported that the requested service is investigational
for the treatment of the enrollees Parkinsons disease. The physician reviewer found that DBS is
indicated in cases of Parkinson's Disease in which motor fluctuations and dyskinesias are present.
DBS is approved by the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson's
Disease. In this case, the patient has motor fluctuations and dyskinesias despite best medical
management, which is standard management for Parkinsons Disease. The patient is now experiencing the known limitations and side effects of standard medication management. In this
clinical setting, the requested service is likely to be more beneficial than standard medical therapy
as DBS reduces motor fluctuations secondary to medications. Therefore, deep brain stimulation is
likely to be more beneficial for treatment of the patients condition than any available standard
therapy.
| 1 |
A 56-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 6/04/21. The Health Insurer has denied this request and reported that the services at
issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 56-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 6/04/21. 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 Melanoma is a cancer that is curable in its earliest stages.
Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph
nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes
may be amenable to excision but this suggests a high-risk for the development of metastatic disease
in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node
biopsy. There has also been some lack of consistency between various genes being used as
biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment
algorithm beyond standard staging techniques. Therefore, DecisionDx-Melanoma testing
performed on 6/04/21 was not likely to have been more beneficial than any available standard
therapy.
| 0 |
The parent of a seven-year-old male enrollee has requested authorization and coverage for Nutropin AQ Nuspin 10. 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 a low body mass index, even for DiGeorge syndrome.
This patient had an actual growth velocity of 4 cm per year in the last year,
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Upheld
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Medical Necessity
|
Summary Reviewer
The parent of a seven-year-old male enrollee has requested authorization and coverage for Nutropin AQ Nuspin 10. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient has a low body mass index, even for DiGeorge syndrome. There is no evidence that the poor weight gain has been addressed properly, as this can lead to growth failure. There is no evidence of what the bone age is on the present notes. This patient had an actual growth velocity of 4 cm per year in the last year, which is reassuring. Patients with DiGeorge syndrome can have hypothyroidism which can also lead to short stature. There is no evidence from the current notes that this has been ruled out. At this time, the medical records do not establish that Nutropin AQ NuSpin 10 is medically indicated. Therefore, Nutropin AQ NuSpin 10 is not medically necessary for the treatment of this patient.
| 1 |
A 47-year-old male enrollee has requested reimbursement for the Oncotype Dx Colon Cancer Assay provided on 2/14/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectosigmoid cancer.
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Upheld
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Experimental
|
Summary Reviewer 3
A 47-year-old male enrollee has requested reimbursement for the Oncotype Dx Colon Cancer Assay provided on 2/14/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectosigmoid cancer. The physician reviewer found that it has not been established in the medical literature whether molecular markers are useful in treatment decisions and prognosis in patients with colon cancer. While an assay may have the ability to help estimate a patients risk of recurrence, whether such increased risk can be overcome by adjuvant chemotherapy remains unclear. In addition, the National Comprehensive Cancer Network (NCCN) guidelines state that there are insufficient data to recommend the use of multi-gene assays, such as the Oncotype DX assay, to determine adjuvant therapy. Thus, the Oncotype DX Colon Cancer Assay provided on 2/14/18 was not likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 20-year-old male enrollee has requested reimbursement for the Anser IFX testing provided on 10/26/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease status post resection.
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Upheld
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Experimental
|
Summary Reviewer 2
A 20-year-old male enrollee has requested reimbursement for the Anser IFX testing provided on 10/26/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease status post resection. The physician reviewer found that in this case, Anser IFX was ordered to determine the patients infliximab level and whether antibodies to infliximab were present. However, the use of Anser IFX to direct management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials of patients with Crohns disease. The presence of antibodies does not necessarily result in loss of response to infliximab, nor have clear infliximab levels been established (Steenholdt, et al). Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response (Vande Casteele, et al; Nanda, et al). A recent study concluded that prospective evaluation of the value of measuring serum concentrations of infliximab should be performed before these data can be included in patient management strategies (Adedokun, et al). One study, with some patients undergoing dose intensification following initial non-response, showed no difference in serum levels of infliximab between patients who responded to dose intensification versus those who did not (Pariente, et al). Although loss of response to infliximab is common, there were no standard guidelines defining a therapeutic strategy at the time of testing (Vande Casteele, et al). Based on the current clinical literature, the Anser IFX testing provided on 10/26/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
patient is a 56-year-old female with a history of elevated liver enzymes, which she attributes to alcohol intake. Ultrasound of the abdomen on 7/01/19 showed heterogeneously increased liver echogenicity, likely hepatic steatosis, and a 4.0 cm hepatic cyst, which was previously 3.0 cm. Magnetic resonance imaging (MRI) of the abdomen with and without contrast was performed on 9/09/19.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 56-year-old female with a history of elevated liver enzymes, which she attributes to alcohol intake. Ultrasound of the abdomen on 7/01/19 showed heterogeneously increased liver echogenicity, likely hepatic steatosis, and a 4.0 cm hepatic cyst, which was previously 3.0 cm. Magnetic resonance imaging (MRI) of the abdomen with and without contrast was performed on 9/09/19. The physician reviewer found that per the American College of Radiology, the recommended test for liver lesions greater than 1 cm in size found on ultrasound is an MRI with and without contrast. This is supported by guidelines from the American Association for the Study of Liver Disease, which state that MRI can determine whether such lesions are hepatocellular carcinoma. The risk of hepatocellular carcinoma is increased in the setting of hepatic steatosis, even in the absence of cirrhosis, and the large liver lesion seen on ultrasound was concerning for hepatocellular carcinoma. Therefore, MRI of the abdomen, without contrast, performed on 9/09/19 was medically necessary for the evaluation of this patient.
| 1 |
A 60-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 7/01/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
|
Upheld
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Experimental
|
Summary Reviewer 2
A 60-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 7/01/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. Gerami reported on 217 cases, with good correlation between DecisionDx-Melanoma testing class and prognosis in patients undergoing sentinel node biopsy. It is not known how the five-year DecisionDx-Melanoma testing data compares to the ten-year Balch data. It is not known if the DecisionDx-Melanoma testing data can be used to make clinical decisions. The National Comprehensive Cancer Network does not recommend the test to make decisions. Therefore, DecisionDx-Melanoma testing performed on 7/01/20 was not likely to have been more beneficial than other available standard therapy.
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A 32-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 9/24/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 32-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 9/24/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index adds a bit to these statistics. DecisionDx-Melanoma testing is a 31-gene assay of the genomic-molecular abnormalities within an individualas melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not known if the DecisionDx-Melanoma classification can be used to make clinical decisions. The decision about whether or not to do a sentinel node is based on thickness and other pathologic features, not DecisionDx-Melanoma classification. The decision about adjuvant therapy is generally based on the results of the sentinel node biopsy, if performed, and other pathologic features. The National Comprehensive Cancer Network does not recommend the use of the DecisionDx-Melanoma assay to make clinical decisions. Therefore, DecisionDx-Melanoma testing performed on 9/24/19 was not likely to have been more beneficial than other available standard therapy.
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A 33-year-old female enrollee has requested reimbursement for laboratory services (82746, 82607 and 82306) provided on 6/05/19. 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 patient is of South Asian descent and had recently returned to the United States after living there for an extended period. He reported that he had been self-medicating with alcohol. He reported shoulder pain, anxiety, and low mood, and also reported being treated with weekly vitamin D supplements in the past.
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Overturned
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Medical Necessity
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Summary Reviewer
A 33-year-old female enrollee has requested reimbursement for laboratory services (82746, 82607 and 82306) provided on 6/05/19. 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 submitted documentation supports the services at issue in this clinical setting. Kennel and colleagues noted, Even when using a conservative definition of vitamin D deficiency, many patients routinely encountered in clinical practice will be deficient in vitamin D. The authors reported, It has been suggested that clinicians should routinely test for hypovitaminosis D in patients with musculoskeletal symptoms, such as bone pain, myalgias, and generalized weakness, because these symptoms are often associated with hypovitaminosis D and might be misdiagnosed as fibromyalgia, chronic fatigue, age-related weakness, or even depression. Green noted, There are numerous known causes of deficiency of folate or vitamin B-12. In some situations, such as chronic generalized malabsorption or malnutrition, deficiencies of both vitamins may coexist. Hunt and colleagues noted that vitamin B12 deficiency occurs at high rates in South Asia. Also, the risk of vitamin B12 deficiency is higher in individuals who consume alcohol heavily. In this case, the patient is of South Asian descent and had recently returned to the United States after living there for an extended period. He reported that he had been self-medicating with alcohol. He reported shoulder pain, anxiety, and low mood, and also reported being treated with weekly vitamin D supplements in the past. For all of the above reasons, it was medically appropriate for the patients provider to check levels of vitamin D, B12, and folate at the initial visit. Therefore, laboratory services (82746, 82607 and 82306) provided on 6/05/19 were medically necessary for the evaluation of this patient.
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A 32-year-old male enrollee has requested authorization and coverage for Gammagard liquid (immune globulin (human) IV or subcutaneous solution 5 gm/50 ml and Gamunex-C. The Health Insurer has denied this request and reported that the medication at issue is investigational for the treatment of the enrollees medical condition.
There has been a diagnosis of peripheral motor polyneuropathy. Medical records from his neurologist describes muscular atrophy and weakness, diminished distal reflexes, and no upper motor neuron signs. Headaches and autonomic dysfunction are also described. He has had treatment with Radicava, which is indicated for treatment of amyotrophic lateral sclerosis.
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Overturned
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Experimental
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Summary Reviewer 3
A 32-year-old male enrollee has requested authorization and coverage for Gammagard liquid (immune globulin (human) IV or subcutaneous solution 5 gm/50 ml and Gamunex-C. The Health Insurer has denied this request and reported that the medication at issue is 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 medication. There has been a diagnosis of peripheral motor polyneuropathy. Medical records from his neurologist describes muscular atrophy and weakness, diminished distal reflexes, and no upper motor neuron signs. Headaches and autonomic dysfunction are also described. He has had treatment with Radicava, which is indicated for treatment of amyotrophic lateral sclerosis. The notes do not include electromyography/nerve conduction velocity studies or autoimmune studies. Based on the available records, the diagnosis is unclear. While motor neuropathy is commonly treated with intravenous immune globulin, there is a lack of evidence that intravenous immune globulin would be helpful for amyotrophic lateral sclerosis. Without a more distinct diagnosis, it is not possible to state that intravenous immune globulin is likely to be more effective than other therapies. Thus, Gammagard liquid (immune globulin (human) IV or subcutaneous solution 5 gm/50 mL) and Gamunex-C is not likely to be more beneficial than other treatment options.
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A 60-year-old male enrollee has requested reimbursement for repair of anorectal fistula provided on 10/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees anal fistula.
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Overturned
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Experimental
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Summary Reviewer 2
A 60-year-old male enrollee has requested reimbursement for repair of anorectal fistula provided on 10/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees anal fistula. The physician reviewer found that the repair of anorectal fistula provided on 10/23/15 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. There is sufficient support in the peer-reviewed literature for the services at issue. The study by Stamos and colleagues study assessed outcomes after implantation of a synthetic bioabsorbable anal fistula plug. The authors concluded Implantation of a synthetic bioabsorbable fistula plug is a reasonably efficacious treatment for complex transsphincteric anal fistulas, especially given the simplicity and low morbidity of the procedure. The use of AFP is the best option to avoid significant anal sphincter muscle damage, and resultant fecal incontinence in this clinical setting. Therefore, AFP was the superior surgical approach for treatment of the fistula without causing significant anal sphincter damage and fecal incontinence. Accordingly, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 63-year-old male enrollee has requested reimbursement for dopamine transporter imaging with a single proton emission computed tomography (DaT SPECT) scan performed on 8/24/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who presented with persistent hand tremors.
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Overturned
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Experimental
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Summary Reviewer 1
A 63-year-old male enrollee has requested reimbursement for dopamine transporter imaging with a single proton emission computed tomography (DaT SPECT) scan performed on 8/24/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who presented with persistent hand tremors. The physician reviewer found that there is sufficient support in the medical literature for the services at issue. While a DaT SPECT study is not required for the diagnosis of all patients suspected to have Parkinsons disease, it has been shown to be useful in cases where the diagnosis is not definitive on clinical grounds. In this particular case, the patients provider suspected Parkinsons disease, although by the history an essential tremor would have been an alternative diagnosis. It is imperative to provide a definitive diagnosis as treatment for essential tremor and Parkinsons disease are quite different. The treatment options for Parkinsons disease can have significant side effects. This patients diagnosis was determined and verified using this study. As such, an appropriate management approach was initiated. The literature demonstrates the use of this study in differentiating cases of Parkinsons and essential tremor. An improper diagnosis could have led to suboptimal management and potential exposure to unnecessary side effects. Therefore, DaT SPECT scan performed on 8/24/16 was likely to have been superior to other methods of evaluating this patients medical condition. Based upon the information set forth above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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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.
. This patient did not have any urodynamic findings suggestive of overactive bladder. It appears that the patient was started on antimuscarinic therapy simultaneously with percutaneous tibial nerve stimulation.
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Upheld
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Experimental
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Summary Reviewer 3
A 56-year-old female has requested reimbursement for percutaneous tibial nerve stimulation performed from 5/08/18 through 8/02/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of urinary frequency and urgency. The physician reviewer found that percutaneous tibial nerve stimulation is considered to be an appropriate third-line salvage therapy for patient with intractable irritative lower urinary tract symptoms, including frequency and urgency incontinence. This patient did not have any urodynamic findings suggestive of overactive bladder. It appears that the patient was started on antimuscarinic therapy simultaneously with percutaneous tibial nerve stimulation. It would have been prudent for this patient to assess the outcome of antimuscarinic therapy prior to therapy with percutaneous tibial nerve stimulation. Thus, percutaneous tibial nerve stimulation performed from 5/08/18 through 8/02/18 was not likely to have been more effective than other available treatment modalities. 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 54-year-old male has requested reimbursement for Anser VDZ test provided on 7/17/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis.
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Upheld
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Experimental
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Summary Reviewer 1
A 54-year-old male has requested reimbursement for Anser VDZ test provided on 7/17/17. 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 that clinically, there did not appear to be any connection between the medication and the new onset neurologic symptoms. Performing the Anser VDZ testing would not clarify whether there was a relationship, as there is no question that the patient was exposed to the drug for a long period with each infusion. This is not antibody mediated. Therefore, the presence of antibody would also not be helpful to know. Finally, there is a lack of support for the use of Anser VDZ testing to optimize reactive treatment though targeted drug measurement. All told, Anser VDZ test provided on 7/17/17 was not likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 61-year-old female enrollee has requested authorization and coverage for Trilogy 100 noninvasive ventilator. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 61-year-old female enrollee has requested authorization and coverage for Trilogy 100 noninvasive ventilator. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested device in this clinical setting. Amyotrophic lateral sclerosis is a progressive neurodegenerative condition that can affect all muscles of the body, including the diaphragm. This can result in significant difficulty with breathing. The use of non-invasive mechanic ventilation has shown a survival benefit. The use of such device has become the standard of care in the management of the symptoms of amyotrophic lateral sclerosis. Therefore, the requested Trilogy 100 non-invasive ventilator is medically necessary for the treatment of this patient.
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A 21-year-old male enrollee has requested reimbursement for mental health inpatient services provided from 9/13/18 through 9/19/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
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Overturned
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Medical Necessity
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Summary Reviewer
A 21-year-old male enrollee has requested reimbursement for mental health inpatient services provided from 9/13/18 through 9/19/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The American Psychiatric Association (APA) guidelines note that hospitalization is usually indicated for patients who are considered to pose a serious threat of harm to themselves or others or who are so severely disorganized or under the influence of delusions or hallucinations that they are unable to care for themselves and need constant supervision or support. All of which apply to this patient on the dates of service in question. Admission for this patient from 9/13/18 through 9/19/18 was in accordance with generally accepted standards of medical practice and clinically appropriate for the patients illness. The current medical evidence supports the services at issue in this setting. Thus, mental health inpatient services provided from 9/13/18 through 9/19/18 were medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 62-year-old female enrollee has requested reimbursement for genetic testing performed on 7/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 62-year-old female enrollee has requested reimbursement for genetic testing performed on 7/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation for the evaluation of the enrollees medical condition. The physician reviewer found that this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines states that while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. 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. Thus, testing (DecisionDx-Melanoma Gene Assay) performed on 7/31/18 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 60-year-old male enrollee has requested authorization and coverage for verapamil. 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.
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Upheld
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Experimental
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Summary Reviewer 2
A 60-year-old male enrollee has requested authorization and coverage for verapamil. 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 penile traction therapy is a therapeutic option for men with Peyronies disease. Penile traction may help to preserve or increase penile length and reduce penile curvature when used as monotherapy or as adjuvant therapy for surgical and intralesional treatments. There is paucity of clinical justification regarding the efficacy of injection therapy with verapamil. Furthermore, addition of verapamil to oral therapy or other nonsurgical therapies does not appear to provide significant improvement. In sum, verapamil is not likely to be superior over other treatment options.
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A 57-year-old male enrollee has requested authorization and coverage for implanted upper airway stimulation device (Inspire). The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees obstructive sleep apnea (OSA).
In this case, the patient presents with a BMI of 31.2, AHI of 25.8 and nonconcentric airway collapse. He has also failed CPAP therapy.
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Upheld
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Experimental
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Summary Reviewer 1
A 57-year-old male enrollee has requested authorization and coverage for implanted upper airway stimulation device (Inspire). The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees obstructive sleep apnea (OSA). The physician reviewer found that as noted in the current medical literature, OSA is an increasingly prevalent clinical problem with significant effects on both personal and public health. CPAP has demonstrated excellent efficacy and low morbidity. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. The STAR trial demonstrated that hypoglossal nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA (Woodson, et al). The results of the STAR trial demonstrated the hypoglossal nerve stimulator to be safe and effective in a small subset of patients with OSA who have failed CPAP. In this case, the patient presents with a BMI of 31.2, AHI of 25.8 and nonconcentric airway collapse. He has also failed CPAP therapy. In this clinical setting, the request for implanted upper airway stimulation device (Inspire) has been established as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees prostate cancer.
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Upheld
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Medical Necessity
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Summary Reviewer
A 60-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees prostate cancer. The physician reviewer found that upon review of available data, the requested proton therapy is not medically necessary for treatment of this patients prostate adenocarcinoma. The Health Insurer states that the patient can be treated with photon based intensity modulated radiation therapy (IMRT). In the peer-reviewed medical literature, Trofimov and colleagues reported that dosimetric studies have shown a benefit in bladder and rectal exposure with proton therapy. However, this benefit has not been demonstrated to result in fewer clinical side effects or improved health outcomes (Sheets, et al; Coen, et al; Yu, et al; Hoppe, et al). In addition, the largest available retrospective study showed that gastrointestinal toxicity was actually higher with proton therapy when compared to photon therapy (Sheets, et al). Moreover, cancer control rates are reportedly similar with photon and proton beam radiation therapy (Coen, et al). All told, there is a paucity of scientific data demonstrating that proton beam radiation therapy is medically necessary for treatment of this patients prostate cancer. Based on the foregoing discussion, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 35-year-old male enrollee has requested authorization and coverage for spine fusion extra segment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the patient is a 35-year-old male with a history of low back pain. On 2/09/15, the medical records noted pain radiating down right lower extremity of three months duration. The documentation indicated a history of right L5-S1 microdiscectomy in September 2013. The provider noted that magnetic resonance imaging (MRI) of the lumbar spine performed in December 2014 showed recurrent disc herniation at L5-S1 with narrowing of right lateral recess. The patient reported that two epidural steroid injections did not improve his symptoms. He has requested coverage for spine fusion extra segment. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient.
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Upheld
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Experimental
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Summary Reviewer 1
A 35-year-old male enrollee has requested authorization and coverage for spine fusion extra segment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the patient is a 35-year-old male with a history of low back pain. On 2/09/15, the medical records noted pain radiating down right lower extremity of three months duration. The documentation indicated a history of right L5-S1 microdiscectomy in September 2013. The provider noted that magnetic resonance imaging (MRI) of the lumbar spine performed in December 2014 showed recurrent disc herniation at L5-S1 with narrowing of right lateral recess. The patient reported that two epidural steroid injections did not improve his symptoms. He has requested coverage for spine fusion extra segment. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient. The submitted records fail to demonstrate the superior efficacy of the requested services. A multilevel fusion for degenerative disc disease is not likely to be beneficial in this patients case. In the absence of instability, for the management of failed spinal surgery syndrome, the medical evidence supports a combination of physical therapies and cognitive therapies rather than a surgical intervention. All told, the requested spine fusion extra segment is not likely to be superior over other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 49-year-old male enrollee has requested authorization and coverage for intraosseous
basivertebral nerve ablation. The Health Insurer has denied this request and reported that the
requested service is investigational for the treatment of the enrollees chronic low back pain.
In this case, the
patient has exhausted and failed the standard treatments for vertebrogenic low back pain for over
six months.
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Overturned
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Experimental
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Summary Reviewer 2
A 49-year-old male enrollee has requested authorization and coverage for intraosseous
basivertebral nerve ablation. The Health Insurer has denied this request and reported that the
requested service is investigational for the treatment of the enrollees chronic low back pain. At
issue is whether intraosseous basivertebral nerve ablation is likely to be more beneficial for
treatment of the enrollee's condition than any available standard therapy. The physician reviewer
found that Conger and colleagues report regarding the effectiveness of intraosseous basivertebral
nerve radiofrequency when compared with a placebo procedure, There is moderate-quality
evidence that suggests this procedure is effective in reducing pain and disability in patients with
chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. In a prospective randomized
multicenter study for basivertebral nerve ablation for the treatment of chronic low back pain,
Koreckij and colleagues determined that disability and pain were improved at 24 months after the
procedure. Macadaeg and colleagues reported similar results at twelve months of follow-up in a
prospective single arm study of intraosseous basivertebral nerve ablation for chronic low back pain
including participants who had failed six months of non-surgical treatments. In this case, the
patient has exhausted and failed the standard treatments for vertebrogenic low back pain for over
six months. Given that current medical literature indicates that basivertebral nerve ablation
consistently demonstrates good results for pain relief and improved disability, the requested
service is likely to be more beneficial for treatment of the patients medical condition than any
available standard therapy. Therefore, intraosseous basivertebral nerve ablation is likely to be more
beneficial for treatment of the patients condition than any available standard therapy.
| 1 |
patient is a 62-year-old male. Notes dated 9/7/21 reported that the patient presented with
scrotal swelling and pain. The patient has requested reimbursement for an inpatient day from
9/8/21 to 9/9/21. The Health Insurer has denied this request and reported that the services at issue
were not medically necessary for the treatment of this patient.
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Upheld
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Medical Necessity
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Summary
The patient is a 62-year-old male. Notes dated 9/7/21 reported that the patient presented with
scrotal swelling and pain. The patient has requested reimbursement for an inpatient day from
9/8/21 to 9/9/21. The Health Insurer has denied this request and reported that the services at issue
were not medically necessary for the treatment of this patient. This denial is the subject of this
appeal and determination. The physician reviewer found that the submitted documentation does
not support the medical necessity of the service at issue. Generally, a patient with orchitis that does
not have urosepsis or require surgery is treated as an outpatient or, at most, under 24-hour
observation. In this case, however, the records note that as the patient had failed an outpatient
course of oral antibiotics, a brief intravenous course needed to be applied prior to outpatient
continuance of care. Given that 24-hour observation, as opposed to an actual inpatient admission,
was appropriate the records did not document complications or that other special procedures were
needed, the services at issue were not medically indicated. Therefore, inpatient day from 9/8/21 to
9/9/21 was not medically necessary for the treatment of this patient.
| 1 |
A 28-year-old male enrollee has requested reimbursement for substance use inpatient detoxification provided from 7/27/17 through 8/08/17 and residential treatment provided from 8/09/17 through 9/11/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
vital signs were stable. He showed no post-acute withdrawal symptoms on
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Upheld
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Medical Necessity
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Summary Reviewer
A 28-year-old male enrollee has requested reimbursement for substance use inpatient detoxification provided from 7/27/17 through 8/08/17 and residential treatment provided from 8/09/17 through 9/11/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that regarding the request for residential services, on step-down, the patients vital signs were stable. He showed no post-acute withdrawal symptoms on admission to residential treatment. This is inconsistent with staffs report of ongoing post-acute symptoms which one would see in the acute phase of opioid withdrawal. As noted above, there were no emotional, behavioral, cognitive, or impulsive issues requiring a 24/7 structured setting. He was not suicidal or homicidal. There was no evidence of any psychotic thought process, mania, or any other condition which would preclude treatment on an ambulatory basis. Standard of practice in the community is medication assisted treatment, which he had previously received. Thus, substance use inpatient detoxification provided from 7/27/17 through 8/08/17 and residential treatment provided from 8/09/17 through 9/11/17 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The guardian of a 17-year-old male enrollee has requested reimbursement for residential treatment provided from 6/05/14 through 10/11/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
This patient had a history of substance abuse, truancy, running away, defiance, and risky and self-destructive behavior. This patient engaged in the therapeutic environment, albeit he was initially resistant to change. He reportedly showed some progress.
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Overturned
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Medical Necessity
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Summary Reviewer
The guardian of a 17-year-old male enrollee has requested reimbursement for residential treatment provided from 6/05/14 through 10/11/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation supports the medical necessity of the services at issue. This patient had a history of substance abuse, truancy, running away, defiance, and risky and self-destructive behavior. This patient engaged in the therapeutic environment, albeit he was initially resistant to change. He reportedly showed some progress. Given this patients level of his behavioral problems, his familys lack of ability to control him, and his defiance of authority, he was not likely to have been receptive to or cooperative with a lower level of care. Based upon the medical records, this patient could not have effectively been treated at a lower level of care. He needed long-term treatment for both substance abuse and behavioral health conditions in a restricted environment. All told, residential treatment provided from 6/05/14 through 10/11/14 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 21-year-old male enrollee has requested reimbursement for applied behavioral analysis (ABA) therapy provided from 1/13/17 through 7/12/17. The Health Plan has denied this request indicating that the services at issue were not medically necessary for treatment of the autism spectrum disorder.
This patient has a diagnosis of autism and continues to have significant delays. The provider indicates that the patient has highly dangerous behaviors that include running off the sidewalk onto the street, crossing the street without scanning the surroundings, and self-harm behaviors. The patient is a safety risk both at home and in the community due to his behaviors.
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Overturned
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Medical Necessity
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Summary Reviewer
A 21-year-old male enrollee has requested reimbursement for applied behavioral analysis (ABA) therapy provided from 1/13/17 through 7/12/17. The Health Plan has denied this request indicating that the services at issue were not medically necessary for treatment of the autism spectrum disorder. The physician reviewer found the ABA therapy provided from 1/13/17 through 7/12/17 was medically necessary for treatment of the patients medical condition. ABA therapy is an evidence-based treatment that has proven benefit in the behavioral treatment of autism (Smith, et al). This patient has a diagnosis of autism and continues to have significant delays. The provider indicates that the patient has highly dangerous behaviors that include running off the sidewalk onto the street, crossing the street without scanning the surroundings, and self-harm behaviors. The patient is a safety risk both at home and in the community due to his behaviors. In addition, the ABA provider has documented goals, tracking progress, and the extent of parental involvement and training indicated to meet the patients behavioral deficits. For the above reasons, the ABA therapy provided from 1/13/17 through 7/12/17 was medically necessary for treatment of the patients medical condition. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 48-year-old male enrollee has requested reimbursement for laboratory testing on 12/2/22. The Health
Insurer has denied this request and reported that services at issue were investigational for the
evaluation of the enrollees premature coronary artery disease and hyperlipidemia.
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Overturned
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Experimental
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Summary Reviewer 3
A 48-year-old male enrollee has requested reimbursement for laboratory testing on 12/2/22. The Health
Insurer has denied this request and reported that services at issue were investigational for the
evaluation of the enrollees premature coronary artery disease and hyperlipidemia. The physician
reviewer found that the elevated lipoprotein(a) is causally implicated in ASCVD, and testing in specific
patients may help to tailor the appropriate intensity of preventive measures. Khera and colleagues
found that lipoprotein(a) is a strong predictor of risk when it remains high in patients who are already on
statin. Select patients that may benefit from lipoprotein(a) testing after a shared decision-making
discussion include individuals with premature CAD with the absence of traditional risk factors. The
results of testing in these patients may trigger an escalation of therapy. Lipoprotein(a) testing may be
reasonable in patients with recurrent or progressive ASCVD despite adequate control of other risk
factors. Lipoprotein(a) testing may be generally recommended for patients with a personal history of
premature cardiovascular disease, recurrent cardiovascular disease while on statin therapy, and a
greater or equal to 10% ten-year risk of cardiovascular disease. The primary reason for screening
patients for lipoprotein(a) is to help further identify those at high risk for heart disease, especially in the
absence of other major risk factors and to help identify those patients who may require more intensive
lipid therapy. Patients with significantly elevated lipoprotein(a) should generally be treated to a target of
less than 50mg/dl. There is a lack of randomized controlled trials on if targeted lowering of
lipoprotein(a) improves clinical outcomes. Studies on the lipoprotein(a) lowering effect of currently
available therapies are ongoing, and there is currently no targeted treatment to lower lipoprotein(a) as
neither lifestyle therapy nor statin therapy impacts lipoprotein(a) levels. One treatment option is daily
niacin, which may lower lipoprotein(a) by 20% to 30%. However, niacin has not been associated with
improved cardiac outcomes despite its known beneficial effect on all lipid markers as well as
lipoprotein(a). Statins have shown mixed results and, in some cases, have actually been shown to
increase lipoprotein(a). PCSK9 inhibitors lower lipoprotein(a), but the contribution of lipoprotein(a)
reduction to reduced ASCVD risk is undetermined. Lipoprotein apheresis lowers lipoprotein(a) and is selectively used for patients with elevated lipoprotein(a) and recurrent ASCVD events regardless of LDL
levels. Antisense oligonucleotides are undergoing investigation as a novel lipoprotein(a) targeting
treatment. Sabatine and colleagues report that the addition of a PCSK9 inhibitor reduced lipoprotein(a)
levels by 27% and resulted in a reduction in major adverse cardiovascular events (MACE). Schwartz and
colleagues report that a PCSK9 inhibitor had increased MACE reduction in individuals with higher
baseline lipoprotein(a) levels. In this case, given that the lipoprotein(a) testing would have aided in
determining if the patient requires more advanced therapy, such as with PCSK9 inhibitor, the service at
issue was likely to have been more beneficial for the evaluation of the patient than standard laboratory
testing. Therefore, laboratory testing on 12/2/22 was likely to have been more beneficial for the
evaluation of the patients condition than any available standard therapy.
| 1 |
A 60-year-old female enrollee has requested reimbursement for collagen crosslinks laboratory tests performed on 1/2/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis.
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Overturned
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Experimental
|
Summary Reviewer 1
A 60-year-old female enrollee has requested reimbursement for collagen crosslinks laboratory tests performed on 1/2/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis. The physician reviewer found that osteoporosis is a condition of thinning of the bones which leads to increased risk of fracture. It is defined by the World Health Organization (WHO) as a bone mineral density of 2.5 standard deviations or more below the mean peak bone mass (average of young, healthy adults) as measured by dual-energy x-ray absorptiometry. Bone mineral density (BMD) assessment, via a bone density test, is still the criterion standard for evaluation and diagnosis of osteoporosis. However, because changes in bone mass and density in response to anti-resorptive therapy account for only a small portion of the predicted fracture risk reduction, markers of bone turnover (proteins and peptides, referred to as biochemical bone markers, that are released as a consequence of the physiological action of osteoblasts and osteoclasts) may be a useful adjunct in monitoring of osteoporotic patients treated with antiresorptive agents. Evidence suggests that biochemical markers could be useful in making therapeutic decisions because, in general, the higher the bone remodeling and bone loss rates, the greater the concentration of bone biochemical markers in blood or urine. These tests may also assist in identifying individuals with elevated bone resorption, who have osteoporosis in whom response to treatment is being monitored. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 60-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 10/29/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for purposes of the enrollees breast cancer screening.
In this particular patient, she has breasts that have been described as being heterogeneously dense.
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Overturned
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Experimental
|
Summary Reviewer 3
A 60-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 10/29/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for purposes of the enrollees breast cancer screening. The physician reviewer found breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. In this particular patient, she has breasts that have been described as being heterogeneously dense. Even though the patients mammogram has not changed since the last study, it is specifically these patients, who have dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. 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 40-year-old female enrollee has requested reimbursement for the Genecept Assay provided by Genomind, Inc. on 2/24/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder.
|
Upheld
|
Experimental
|
Summary Reviewer 2
A 40-year-old female enrollee has requested reimbursement for the Genecept Assay provided by Genomind, Inc. on 2/24/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. The physician reviewer found that based on the review of the submitted documentation, Genecept Assay provided by Genomind, Inc. on 2/24/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Pharmacogenetic testing in psychiatry is a newly evolving field but large randomized controlled trials are needed to further substantiate the utility of genetic testing in this clinical setting. A review of the available literature regarding pharmacogenetic testing suggests that it has been studied that to the extent that genetic factors are associated with the efficacy, tolerability, and safety of different drugs, pharmacogenetic tests may be used to personalize medication treatments for an individual patient. However, pharmacogenetic tests, such as the Genecept Assay, have a lack of evidence to support their clinical validity or utility. Overall, there is a lack of large randomized controlled trials that conclude the efficacy of pharmacogenetic testing in psychiatry. For these reasons, the Genecept Assay provided by Genomind, Inc. on 2/24/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
An 18-year-old male enrollee has requested reimbursement for outdoor behavioral health
services provided from 11/03/20 through 12/31/20. The Health Insurer has denied this request
and reported that the services at issue were investigational for the treatment of the enrollees
medical condition.
|
Upheld
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Experimental
|
Summary Reviewer 1
An 18-year-old male enrollee has requested reimbursement for outdoor behavioral health
services provided from 11/03/20 through 12/31/20. 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 a number of studies have demonstrated
that outdoor behavioral health (OBH) programs are associated with reduced frequency of
substance use and improved interpersonal relationships. Gass and colleagues compared the
effectiveness of three post-acute adolescent substance use situations: outdoor behavioral health
program (OBH), treatment as usual, and no structured treatment. Results of the study found that
in the OBH group, completion rates were higher, and the treatment outcomes were 424% better
as measured by the Youth Outcome Questionnaire. Despite the reported positive benefits of
OBH, the literature does not support claims that OBH is more effective than other therapies.
There are very few studies which directly compare outcomes of OBH to other therapeutic
interventions. Although OBH can be an effective treatment intervention for adolescent substance
use and mental health disorders, there is no evidence to support the claim that it is superior to
the standard of care. Although the OBH literature contains a number of studies that suggest that
participants show some level of improvement on behavioral health outcomes, there are
considerable limitations in the research methodology used to examine these programs and the
results are not conclusive. Most notably, there is a lack of randomized controlled trials or well-
designed cohort studies that would allow causal conclusions about the impact of OBH to be
drawn. Review of studies did not reveal OBH to be better than standard treatment. Therefore,
outdoor behavioral health services provided from 11/03/20 through 12/31/20 was not likely to
have been more beneficial than any available standard therapy.
| 0 |
The patient is a 56-year-old male with a history of elevated prostate specific antigen (PSA) of 7.4
ng/mL and prostate cancer. The patient was evaluated by a radiation oncologist who
recommended combined short-term androgen deprivation therapy with proton beam radiation
treatment. The Health Insurer has denied this request and reported that the services at issue are
not medically necessary for the treatment of this patient.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
The patient is a 56-year-old male with a history of elevated prostate specific antigen (PSA) of 7.4
ng/mL and prostate cancer. The patient was evaluated by a radiation oncologist who
recommended combined short-term androgen deprivation therapy with proton beam radiation
treatment. The Health Insurer has denied this request and reported that the services at issue are
not medically necessary for the treatment of this patient. The physician reviewer found that the
patients provider recommended a course of radiation therapy for the patients early stage
prostate cancer. Per the National Comprehensive Cancer Network (NCCN) guidelines, the
utilization of proton beam radiation therapy as a treatment modality is not supported for the
routine treatment of patients with prostate cancer. Proton beam radiation therapy has unique
properties compared to standard photon beam radiation therapy or x-ray beam radiation
therapy in its ability to deposit radiation dose. However, there is a lack of data demonstrating
that the use of proton beam radiation therapy will result in any significant improvement in clinical
outcome (Royce and Efstathiou). Thus, proton beam radiation therapy is strongly indicated in
settings where severe toxicities would result if normal tissue constraints cannot be met by
photon beam. Additional studies have not demonstrated clinically significant improvements in
survival or normal tissue toxicities over photon beam when treating prostate cancer (Royce, et
al.). In addition, proton beam radiation therapy may be appropriate in cases of unusual anatomy
or in cases of re-irradiation of adjacent tissues. On review of this patients records, there is a lack
of documentation of unusual anatomy or previous radiation in the target area. Given these
findings, the requested proton beam radiation therapy is not medically necessary for treatment
of this patient.
| 1 |
The parent of a seven-year-old male enrollee has requested authorization and coverage for speech therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees speech misarticulations.
|
Overturned
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Medical Necessity
|
Summary Reviewer
The parent of a seven-year-old male enrollee has requested authorization and coverage for speech therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees speech misarticulations. The physician reviewer found that to the literature, speech and language deficits that persist into the primary school years have long-term effects on literacy, school success, socialization, and behavior. In particular, speech sound disorders not only greatly reduce intelligibility, but have also been associated with later reading disability. Speech sound disorders refer to any combination of difficulties that impact speech intelligibility, including perception, motor production, and phonological representation of speech sounds and segments. Articulation disorders are those that impact the form of speech sounds and are associated with structural and motor-based problems. Phonology disorders impact the way speech sounds function within a language. Treatment approaches have traditionally focused on either articulation or phonology. Articulation approaches are typically selected if the problem is thought to be motor-based, and phonologic approaches tend to target specific sound error patterns. The literature supports speech therapy intervention for young children with speech sound disorders. In this patients case, the records document misarticulations negatively impacting his intelligibility, in addition to oral-lingual structural abnormalities and oral-motor deficiencies, all resulting in a speech sound/production disorder. All told, the requested speech therapy is medically indicated for the treatment of this patient. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 0 |
The parent of a 15-year-old male enrollee has requested reimbursement for quantification of therapeutic drug, not elsewhere specified and immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative,
, performed on 12/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
that this patient demonstrated loss of response with breakthrough symptoms prior to his scheduled medication doses.
|
Overturned
|
Experimental
|
Summary Reviewer 3
The parent of a 15-year-old male enrollee has requested reimbursement for quantification of therapeutic drug, not elsewhere specified and immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified, performed on 12/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient demonstrated loss of response with breakthrough symptoms prior to his scheduled medication doses. Measurement of drug and antibody levels has now been incorporated into professional guidelines, which include recommendations for both proactive and reactive therapeutic drug monitoring. Expert consensus guidelines state that it is appropriate to order drug and antibody concentration testing for all anti-tumor necrosis factor medications, including infliximab, in patients with a confirmed secondary loss of response. Guidelines specifically focusing on the pediatric age range reflect the same conclusion. The studies by Afif and colleagues and Yanai and Hanauer indicate that measurement of infliximab levels and anti-infliximab (anti-chimeric) antibodies produces actionable data. Change of dose or drug based on these results improves response to treatment, as measured by clinical response. In clinical practice, infliximab levels and antibodies allow the provider to adjust or change biologic therapy with some objective determinants. Thus, quantification of therapeutic drug, not elsewhere specified and immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified, performed on 12/10/19 was likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
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 patient is status post anterior cervical discectomy and fusion in 2019, with no relief of symptoms and
|
Upheld
|
Experimental
|
Summary Reviewer 3
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 this case was previously reviewed, and additional records were submitted. These additional records fail to demonstrate the superior efficacy of the services at issue. Cervical discogram or provocative discography in general has been controversial. In this case, it was unlikely that multiple levels were the cause of discogenic neck pain with normal imaging studies and absent any disc herniations. The patient is status post anterior cervical discectomy and fusion in 2019, with no relief of symptoms and significant narcotics use. The level of evidence for provocative discography is low in this setting. Therefore, cervical discography injection provided on 6/25/20 was not likely to have been more beneficial than other available standard therapy.
| 1 |
A 46-year-old male has requested reimbursement for air ambulance transportation provided on 9/04/19. 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.
. Martin Andrew Donlan, a physiatrist with the Roger C. Pearce Rehabilitation Hospital in Greenville, South Carolina, was consulted to assess the patient on 8/26/19. The Roger C.
Dr. Donlan recommended that the patient would benefit from an acute, multid
patient rehabilitation program. His consultation note indicated, Discussed
. The decision to transport the patient to University of Pittsburg Medical Center in Pittsburgh, Pennsylvania, was made by the patient and his spouse in order to be closer to home.
. He was medically stable for discharge from the hospital to an inpatient rehabilitation facility.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
A 46-year-old male has requested reimbursement for air ambulance transportation provided on 9/04/19. 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 Dr. Martin Andrew Donlan, a physiatrist with the Roger C. Pearce Rehabilitation Hospital in Greenville, South Carolina, was consulted to assess the patient on 8/26/19. The Roger C. Peace Hospital Rehabilitation Center is a 53-bed unit that specializes in caring for people with traumatic brain injury and other conditions. Dr. Donlan recommended that the patient would benefit from an acute, multidisciplinary inpatient rehabilitation program. His consultation note indicated, Discussed recommendations with patient and spouse and both are in preference of going back to home state of Pennsylvania to complete inpatient rehabilitation stay. The decision to transport the patient to University of Pittsburg Medical Center in Pittsburgh, Pennsylvania, was made by the patient and his spouse in order to be closer to home. University of Pittsburg Medical Center was not the closest facility capable of providing inpatient rehabilitation services. Such services were available at the Roger C. Peace Hospital Rehabilitation Center. Further, at the time of transport, the patients condition was not life-threatening. He was medically stable for discharge from the hospital to an inpatient rehabilitation facility. Criteria for emergent air ambulance transport were not met in this case. Therefore, air ambulance transportation provided on 9/04/19 was not medically necessary for the treatment of this patient.
| 1 |
A 55-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 1/24/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
|
Overturned
|
Experimental
|
Summary Reviewer 2
A 55-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 1/24/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that this patient has a low risk prostate cancer, and molecular profiling was considered for guiding therapy decision making. National Comprehensive Cancer Network guidelines recommend Oncotype DX tumor-based molecular assays post-biopsy for men with low or favorable intermediate risk disease. Retrospective studies have shown that molecular assays performed on prostate biopsy or radical prostatectomy specimens provide prognostic information independent of National Comprehensive Cancer Network risk groups. These include, but are not limited to, likelihood of biochemical progression after radical prostatectomy or external beam therapy and likelihood of developing metastasis after radical prostatectomy or salvage radiotherapy. Men with clinically localized disease may consider the use of tumor-based molecular assays. It is considered a standard of care in guiding treatment decision making. In sum, Oncotype DX Prostate testing performed on 1/24/19 was likely to have been more beneficial than any available standard therapy.
| 1 |
A 58-year-old male enrollee has requested authorization and coverage for Testim. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees low testosterone.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
A 58-year-old male enrollee has requested authorization and coverage for Testim. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees low testosterone. The physician reviewer found that on the presented clinical records submitted for review, Testim is not medically necessary for treatment of the patients medical condition. According to the documentation submitted for review, the patients testosterone levels are normal. There are no laboratory tests showing luteinizing hormone or follicle stimulation hormone levels. Furthermore, there is a lack of documentation demonstrating low bone mineral density, low libido or weight loss. Given the lack of support in the documentation provided, the request for Testim has not been established as medically necessary for treatment of the patients medical condition. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 42-year-old female who presented to her provider on 10/26/22 with a diagnosis
of squamous cell carcinoma in situ. The patient has requested reimbursement for high dose rate
electronic brachytherapy, skin surface application, per fraction, including basic dosimetry, when
performed, from 11/15/22 through 12/13/22. The Health Insurer has denied this request and
reported that the services at issue were not medically necessary for the treatment of this patient.
|
Overturned
|
Medical Necessity
|
Summary Reviewer
The patient is a 42-year-old female who presented to her provider on 10/26/22 with a diagnosis
of squamous cell carcinoma in situ. The patient has requested reimbursement for high dose rate
electronic brachytherapy, skin surface application, per fraction, including basic dosimetry, when
performed, from 11/15/22 through 12/13/22. The Health Insurer has denied this request and
reported that the services at issue were not medically necessary for the treatment of this patient.
The physician reviewer found that the submitted documentation supports the medical necessity
of the services at issue. Squamous cell carcinoma in situ is a precursor to squamous cell carcinoma
that should be treated. There are a variety of modalities for the treatment of basal cell carcinoma
and squamous cell carcinoma including surgery, radiation therapy, and topical agents. Although
surgical excision is the primary treatment approach for curative treatment of non-melanoma skin
cancers, radiation therapy can play an integral role in both the definitive and adjuvant settings.
In patients who cannot undergo or decline surgical resection, definitive radiotherapy is
recommended as a curative treatment modality. Radiation treatment is a non-invasive treatment
with similar cure rates to surgery. Radiation therapy, including external beam and brachytherapy
techniques, has been used as primary and post-surgical adjuvant therapy for non-melanoma skin
cancers. High dose rate brachytherapy (HDR-BT) using skin surface applicators or surface molds
has several advantages over electron beam radiotherapy, particularly for irregular surfaces and
difficult areas such as in and around the nose or earlobe, including: (1) Electron beam
radiotherapy for irregular surfaces and facial areas, such as the nose, may be associated with
setup errors and difficulty in planning, (2) HDR-BT provides a rapid dose fall-off outside the target
volume, (3) HDR-BT provides important potential advantages by reducing the number of
treatments and the duration of the treatment schedule, and (4) in addition to excellent local
control, HDR-BT has an appealing cosmetic outcome, with some series reporting excellent
cosmetic outcomes in 98% of patients treated. In this case, the patient had a very small lesion on
her nose. Given the size and location of the lesion, a very small electron field would have been
required to treat this lesion if electron beam radiotherapy is used. Significant dosimetry
challenges and uncertainties exist when small field electron beam radiotherapy is utilized to treat
skin cancers or superficial lesions. Complex dosimetric measurements would have been required
for accurate treatment planning using small field electron beam radiotherapy due to physical and
dosimetric characteristics of small radiotherapy electron beams. In this clinical setting, HDR
electronic brachytherapy was the preferred radiation treatment option and was medically
indicated. Therefore, high dose rate electronic brachytherapy, skin surface application, per
fraction, including basic dosimetry, when performed, from 11/15/22 through 12/13/22, was
medically necessary for the treatment of this patient.
| 1 |
A 45-year-old male enrollee has requested authorization and coverage for radiofrequency ablation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.
|
Upheld
|
Experimental
|
Summary Reviewer 1
A 45-year-old male enrollee has requested authorization and coverage for radiofrequency ablation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. At issue is whether the requested services are likely to be more beneficial for treatment of the enrollee's condition than any available standard therapy. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the requested services. Yang and colleagues performed a literature search for publications on the effectiveness of sacral lateral branch radiofrequency ablation for sacroiliac joint pain. The authors noted, aOne pragmatic study did not show any difference between radiofrequency ablation and control treatment consisting of a standardized exercise program for sacroiliac joint pain. However, recalculation of success rates according to intention to treat analysis demonstrates a significantly higher success rate associated with sacral lateral branch radiofrequency ablation and exercise compared with exercise alone.a However, the authors also indicated, aHeterogeneity in technology and technique call into question the generalizability of the current literature.a Furthermore, the authors noted, aEstablishing the prevalence of posterior sacroiliac joint pain with pain that is relieved by multisite, multi-depth blocks is essential to furthering our understanding of sacroiliac joint region pain and optimizing treatment. Randomized, placebo-controlled studies using multisite, multi-depth sacral lateral branch (SLB) blocks to enroll patients for sacral lateral branch radiofrequency ablation compared with sham treatments are needed to assess the efficacy of this procedure.a In this case, the patient has a history of positive response to diagnostic procedure with no benefit from definitive procedure in both the lumbar spine for fusion as well as the spinal cord stimulator trial and implantation. The requested treatment is not superior to standard treatments. Therefore, the requested radiofrequency ablation is not likely to be more beneficial for treatment of the patient than any available standard therapy.
| 0 |
A 23-year-old male enrollee has requested reimbursement for physical therapy performed from 7/14/15 through 10/31/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees chronic pelvic pain syndrome.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
A 23-year-old male enrollee has requested reimbursement for physical therapy performed from 7/14/15 through 10/31/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees chronic pelvic pain syndrome. The physician reviewer found the services at issue were not medically necessary for treatment of his medical condition. The standard for outpatient physical therapy in treatment of pelvic pain and urinary or defecatory dysfunction is through the use of various modalities and techniques which are utilized to decrease pain and to rehabilitate the intrinsic pelvic floor musculature and extrinsic musculature of the lumbosacral spine. These various modalities increase the patients awareness and voluntary control of these muscles, while educating the patient on proper bowel/bladder techniques and habits. The standard course of physical therapy would include an initial trial of eight treatments. If there was benefit to the patient, an additional 16 treatments could be considered. After the initial physical therapy, transition to an independent exercise program would be expected with a fading of skilled therapy treatments. If there was a lack of improvement, then a reevaluation in terms of reasonable therapy goals or consideration of further medical workup would be the expected management. In this case, the number of therapies that were provided from 7/14/15 through 10/31/15 exceeded the standard number of treatments. For the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
A 19-year-old female enrollee has requested reimbursement for a Papanicolaou (Pap) smear
performed on 1/03/22. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition.
|
Upheld
|
Experimental
|
Summary Reviewer 1
A 19-year-old female enrollee has requested reimbursement for a Papanicolaou (Pap) smear
performed on 1/03/22. 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 cervical cancer screening with Pap smear testing is a preventative measure
included in a routine well-women examination. Per current medical care and American College
of Obstetricians and Gynecologists (ACOG) guidelines, screening is typically initiated at age 21. In
this clinical scenario, the patient was 19 years old on the date of service in dispute. Per the
standard of care, it would have been appropriate for the provider to defer screening until age 21,
as per the guidelines. Therefore, the Pap smear performed on 1/03/22 was not likely to have
been more beneficial for evaluation of the patient than any available standard therapy.
| 0 |
A 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 7/29/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer.
This particular patient has breasts that have been described as being heterogeneously dense.
|
Overturned
|
Experimental
|
Summary Reviewer 2
A 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 7/29/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that Tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, by separating the various layers of breast tissue, one can better detect abnormalities. This particular patient has breasts that have been described as being heterogeneously dense. It is specifically those patients who have dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 7/29/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 49-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma assay provided on 2/14/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.
|
Upheld
|
Experimental
|
Summary Reviewer 2
A 49-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma assay provided on 2/14/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the National Comprehensive Cancer Network (NCCN) guidelines indicate that genetic testing such as the DecisionDx-Melanoma gene assay should not be used outside of a clinical trial setting. The use of this type of testing is not considered to be standard of care in the evaluation of this patients melanoma. Moreover, the DecisionDx-Melanoma gene assay is not expected to impact the treatment or outcome of this patients melanoma. All told, the DecisionDx-Melanoma assay provided on 2/14/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
An 80-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire airway stimulation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.T
this patient has obstructive sleep apnea and has no significant nasal obstruction. The drug-induced sleep endoscopy showed no concentric collapse at velum and primarily anterior posterior collapse at the oropharynx. The patient has not been able to tolerate the continuous positive airway pressure (CPAP) device.
|
Overturned
|
Experimental
|
Summary Reviewer 1
An 80-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire airway stimulation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.The physician reviewer found that this patient has obstructive sleep apnea and has no significant nasal obstruction. The drug-induced sleep endoscopy showed no concentric collapse at velum and primarily anterior posterior collapse at the oropharynx. The patient has not been able to tolerate the continuous positive airway pressure (CPAP) device. The Inspire device has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of obstructive sleep apnea. At this point, the patient is a candidate for the Inspire device given the intolerance to CPAP, anterior posterior collapse at the oropharynx, and body mass index and apnea-hypopnea index within FDA criteria. Therefore, hypoglossal nerve stimulation or Inspire airway stimulation is likely to be more beneficial than any available standard therapy.
| 1 |
The patient is a 46-year-old female who has been diagnosed with metastatic signet ring cell adenosarcoma. The patient was initially diagnosed in November 2016. She is currently being treated with folinic acid, fluorouracil and oxaliplatin (FOLFOX) chemotherapy. Prior therapies have included bilateral ureteral stenting, folinic acid fluorouracil and irinotecan (FOLFIRI) and paclitaxel with ramucirumab. Based on a molecular profiling performed with FoundationOne testing, the provider recommended treatment with Cabometyx. The Health Insurer denied the request for coverage and authorization on the basis that the requested Ca
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 46-year-old female who has been diagnosed with metastatic signet ring cell adenosarcoma. The patient was initially diagnosed in November 2016. She is currently being treated with folinic acid, fluorouracil and oxaliplatin (FOLFOX) chemotherapy. Prior therapies have included bilateral ureteral stenting, folinic acid fluorouracil and irinotecan (FOLFIRI) and paclitaxel with ramucirumab. Based on a molecular profiling performed with FoundationOne testing, the provider recommended treatment with Cabometyx. The Health Insurer denied the request for coverage and authorization on the basis that the requested Cabometyx 60 mg is not medically necessary for the treatment of this patients medical condition. This denial is the subject of this appeal and determination. There is a lack of support for the requested medication in this clinical setting. Cabometyx (cabozantinib) is not U.S. Food and Drug Administration approved for the treatment of gastric cancer. Off-label use is not supported by major drug compendia or the National Comprehensive Cancer Network guidelines. In addition, the medical literature does not reveal clinical trials that support the use of cabozantinib for patients who are diagnosed with gastric cancer. As such, the efficacy of Cabometyx 60 mg for treatment of this patients medical condition has not been established. Therefore, for the reasons stated above, Cabometyx 60 mg is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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The patient is a 54-year-old female who has been diagnosed with lipedema. The patient has requested reimbursement for suction assisted lipectomy, trunk, suction assisted lipectomy, upper extremity and suction assisted lipectomy, lower extremity performed on 6/11/20, 8/13/20, 10/01/20 and 11/18/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient and were not reconstructive in nature.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 54-year-old female who has been diagnosed with lipedema. The patient has requested reimbursement for suction assisted lipectomy, trunk, suction assisted lipectomy, upper extremity and suction assisted lipectomy, lower extremity performed on 6/11/20, 8/13/20, 10/01/20 and 11/18/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient and were not reconstructive in nature. The physician reviewer found that Peled and Kappos note, aLipedema is an uncommon disorder characterized by localized adiposity of the lower extremities, often occurring in females with a family history of the condition. The adiposity extends from hips to ankles and is typically unresponsive to weight loss. In addition to the aesthetic deformity, women also describe pain in the lower extremities, particularly with pressure, as well as easy bruising. Although the condition is well described, it is relatively rare and often misdiagnosed.a The authors noted, aOne of the major distinguishing features of lipedema is the sparing of the feet, which can create a distinct step-off at the ankleaDistinguishing lipedema from other conditions causing fatty excess in the lower extremities can be difficult. Making the diagnosis relies on some of the hallmark characteristics of lipedema, such as the easy bruising and pain with soft tissue pressure, as well as the step-off at the ankles. Women with generalized obesity typically do not have these history and physical exam characteristics. Additionally, although many patients with lipedema may also be overweight, those who have tried to lose weight through diet and exercise typically find that reducing the size of their legs is very challenging, which is often not the case in women with standard obesity. This distinction is less clear, however, in women who have localized adiposity in the lower extremities that is not due to lipedema. Similar to lipedema, localized adiposity in some areas of the legs, particularly the outer thighs, around the knees, and the lower calves, can be very resistant to diet and exercise in some women. Further, some women with lipedema may also have additional areas of localized adiposity, making the diagnosis even more challenging.a Reich-Schupke and colleagues stated, aThe diagnosis [of lipedema] is established on the basis of medical history and clinical findings. Characteristically, there is a localized, symmetrical increase in subcutaneous adipose tissue in arms and legs that is in marked disproportion to the trunk. Other findings include edema, easy bruising, and increased tenderness. Further diagnostic tests are usually reserved for special cases that require additional workup. Lipedema is a chronic, progressive disorder marked by the individual variability and unpredictability of its clinical course.a The authors noted, aTreatment consists of four therapeutic mainstays that should be combined as necessary and address current clinical symptoms: complex physical therapy (manual lymphatic drainage, compression therapy, exercise therapy, and skin care), liposuction and plastic surgery, diet, and physical activity, as well as psychotherapy, if necessary. Surgical procedures are indicated if - despite thorough conservative treatment - symptoms persist, or if there is progression of clinical findings and/or symptoms. If present, morbid obesity should be therapeutically addressed prior to liposuction.a Herbst and colleagues stated, aRemoval of lipedema fat by liposuction that spares lymphatic vessels (wet, not dry, technique) has been performed primarily in Europe, especially in Germany, since the 1990s. The fat is saturated with Klein solution which includes saline or lactated Ringers solution, an anesthetic such as lidocaine or prilocaine, epinephrine, sodium bicarbonate buffer, usually without steroid. This tumescent technique provides turgor to the tissue allowing blunt microcannula to slide through the fat tissue avoiding creation of shearing forces and tissue damage. When power assisted, tiny, rapid vibrations of the microcannula break up fat which is then suctioned out of the tissue. Water jet assisted liposuction (WAL) uses jets of saline and Klein solution to release fat for suction with minimal damage to cells and vessels without the waiting period required to tumesce the tissue. Laser assisted tumescent liposuction is another technique which some reserve for fibrotic areas such as the posterior thighs.a This patient has morbid obesity. Photographs show generalized weight deposition with significant truncal fat and omental fat. The weight in the limbs is not disproportionate to the weight in the trunk. Discrete ankle cuffing or bracelet effect is not visible in the photographs received for review. Wrist cuffing is not visible on the photographs received for review. There is no history of pain and hypersensitivity to touch, and there is no documentation of easy bruising. She complains of severe difficulty ambulating, but she has symptomatic osteoarthritis of her knees and hips with limitation of range of motion due to joint pain. Based on the medical history and the photographs received for review, the patient does not have documented lipedema. The California reconstructive surgery statute requires health insurers to cover reconstructive surgeries, defined as surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) to improve function or (2) to create a normal appearance, to the extent possible. The patient has morbid obesity without documentation of lipedema. Obesity is an abnormal structure of the body. Obesity is considered an endocrine disorder. It is a structural change that is an accommodative response to fat cell response to endocrine inputs. The appearance of the patient is consistent with the gain of weight. The services at issue are likely to both improve function and create a normal appearance, to the extent possible. The California Reconstructive Surgery Act is applicable to this patient. Therefore, lipectomy, trunk, suction assisted lipectomy, upper extremity and suction assisted lipectomy, lower extremity performed on 6/11/20, 8/13/20, 10/01/20 and 11/18/20 were reconstructive in nature.
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A 41-year-old male enrollee has requested reimbursement for intravenous immunoglobulin provided from 4/24/15 through 5/01/15 and 8/07/15 through 8/14/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.
paraneoplastic neuropathies. This patient has been diagnosed with polyneuropathy.
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Upheld
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Medical Necessity
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Summary Reviewer
A 41-year-old male enrollee has requested reimbursement for intravenous immunoglobulin provided from 4/24/15 through 5/01/15 and 8/07/15 through 8/14/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the efficacy of intravenous immunoglobulin has been proven in Guillain-Barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, multifocal mononeuropathy, acute exacerbations of myasthenia gravis, short-term treatment of severe myasthenia gravis, and some paraneoplastic neuropathies. This patient has been diagnosed with polyneuropathy. Clinical examination does not describe neuropathy features such as distal weakness or reflex loss. Nerve conduction velocities were mildly slowed, consistent with demyelination, but there was no evidence of conduction block reported. There was no distal latency prolongation, increased temporal dispersion, or delayed or absent F waves reported. Per the submitted documentation, this patient does not meet published criteria for CIDP, which indicate that the diagnosis rests upon a combination of clinical, electrodiagnostic and laboratory features with exclusions to eliminate other disorders that may appear as CIDP. There is a lack of support for the services at issue in this clinical setting. All told, intravenous immunoglobulin provided from 4/24/15 through 5/01/15 and 8/07/15 through 8/14/15 was 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 43-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/8/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts. The physician reviewer found that the patient is a 43-year-old female who was asymptomatic with respect to her breasts. Her immediate breast history dates back to 4/3/15 when she had a screening mammogram that demonstrated a suspicious nodule in the right breast. After the 4/3/15 mammogram, she was recalled for additional imaging including compression views on 5/5/15, and the nodule persisted. Following the 5/5/15 study, it was recommended that a sonogram be performed. The results of the sonogram were not submitted. She returned on 8/8/16 for a screening mammogram, and no significant abnormalities were detected. The 8/8/16
. Her breast tissue was described as containing scattered fibroglandular elements. The Health Insurer denied reimbursement noting that the service at issue was investigational for the evaluation of this patient.
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Overturned
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Experimental
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Summary Reviewer 3
A 43-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/8/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts. The physician reviewer found that the patient is a 43-year-old female who was asymptomatic with respect to her breasts. Her immediate breast history dates back to 4/3/15 when she had a screening mammogram that demonstrated a suspicious nodule in the right breast. After the 4/3/15 mammogram, she was recalled for additional imaging including compression views on 5/5/15, and the nodule persisted. Following the 5/5/15 study, it was recommended that a sonogram be performed. The results of the sonogram were not submitted. She returned on 8/8/16 for a screening mammogram, and no significant abnormalities were detected. The 8/8/16 study consisted of a combination two dimensional and three dimensional tomosynthesis study. This study was compared to prior mammograms. There were no masses, areas of suspicious calcifications, or areas of architectural distortion. Her breast tissue was described as containing scattered fibroglandular elements. The Health Insurer denied reimbursement noting that the service at issue was investigational for the evaluation of this patient. Breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. In this particular patient, there was an abnormality on her mammograms in 2015 that warranted further attention. It is unclear what the outcome was after those evaluations, but since no mention was made of a biopsy, it is reasonable to conclude that the sonogram revealed either nothing, or more likely, a cyst. In either of those two settings, it is not unreasonable to perform a tomosynthesis as a follow-up study. As mentioned above, tomosynthesis offers the advantage of separating out overlapping structures and can better delineate the margins of a suspected mass or cyst. As this is the first follow-up after detection of a mass, digital breast tomosynthesis performed on 8/8/16 was more likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 60-year-old male enrollee has requested reimbursement for Oncotype testing performed on 4/25/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 60-year-old male enrollee has requested reimbursement for Oncotype testing performed on 4/25/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features, such as the grade of tumor and prostate-specific antigen level. This helps guide the most appropriate therapy for patients taking into account their age and comorbidities because many patients will not require therapy (i.e. surgery or radiation) and may be followed closely instead. The important features to recognize are Gleason score and prostate-specific antigen, but these are imperfect. At this time, current biomarkers are inadequate for risk stratification, and better prognostic biomarkers are needed. Oncotype DX is a gene expression analysis of target genes in the biopsy specimen that generates a genomic prostate score. This assay may help identify patients with low risk disease that could be followed rather than referred for surgery. Oncotype DX may better stratify such patients with localized disease. Thus, Oncotype DX testing performed on 4/25/19 was likely to have been more beneficial than other methods of evaluating this patient.
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A 45-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 1/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 45-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 1/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that FoundationOne CDx assay is a molecular assay that explores the mutations and other alterations of several hundred genes in an individuals cancer cells. The hope is that the assay will identify a target at which a chemotherapeutic agent could be directed for clinical benefit. Thus far, however, there is a lack of convincing evidence that the assay identifies useful targets often enough to be clinically beneficial. A randomized trial by Le Tourneau and colleagues did not demonstrate that picking a drug using such an assay was superior to picking a drug based on the oncologists judgment. Marquart and colleagues demonstrated that only a small minority of patients might benefit from using the assay to pick their therapy. Therefore, FoundationOne CDx testing performed on 1/29/19 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 51-year-old male has requested reimbursement for gene expression profiling performed on 5/04/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
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Upheld
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Experimental
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Summary Reviewer 2
A 51-year-old male has requested reimbursement for gene expression profiling performed on 5/04/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that there is a lack of support for the services at issue in this patients case. There is a lack of evidence from the literature that tailored follow-up according to these test results has an impact on long-term outcomes. Prospective randomized studies to determine recurrence risk is lacking for this test. The medical evidence has not determined the superior efficacy of the services at issue. Thus, gene expression profiling performed on 5/04/17 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 47-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C.
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Overturned
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Medical Necessity
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Summary Reviewer
A 47-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C. The physician reviewer found according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per the guidelines, treatment-naive genotype 1 patients should be treated with Harvoni for 12 weeks. The current medical evidence supports the requested medication in this clinical setting. All told, Harvoni is medically indicated for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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The parent of a 16-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 12/13/13. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees ulcerative colitis.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a 16-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 12/13/13. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found the Prometheus Anser IFX diagnostic testing performed on 12/13/13 was likely to be more effective for this patient than other available treatment options. Anser IFX testing is commonly used in gastroenterology practices and has been well studied. There is sufficient peer-review literature supporting its usefulness in treating patients with irritable bowel syndrome and guiding therapy. Prometheus Anser IFX testing informs the provider if the serum levels of drug are in the range to be beneficial and effective or if they have antibodies that could potentially lead to a reaction or failure to respond. This helps guide the provider in dosing or may lead to discontinuation of the drug if the patient is not likely to benefit from the medication. All told, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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patient is a 62-year-old female with a medical history including alcoholism, depression and anxiety who presented to the emergency department with an altered mental status after reportedly overdosing on medications. She was brought in by EMS with reports of taking Valium, Codeine and propranolol. At the time of presentation, her blood pressure and respiratory rate were stable.
at the time of admission, the patient was hemodynamically stable, afebrile with normal oxygen saturations on room air. She was diagnosed with an intentional overdose at the time of admission although psychiatry determined that she did not require a hold due to denial of intention to harm herself. She did not have any significant cardiac arrhythmias or electrolyte disturbances. She was stable for discharge within two days of admission.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 62-year-old female with a medical history including alcoholism, depression and anxiety who presented to the emergency department with an altered mental status after reportedly overdosing on medications. She was brought in by EMS with reports of taking Valium, Codeine and propranolol. At the time of presentation, her blood pressure and respiratory rate were stable. The physician reviewer found that at the time of admission, the patient was hemodynamically stable, afebrile with normal oxygen saturations on room air. She was diagnosed with an intentional overdose at the time of admission although psychiatry determined that she did not require a hold due to denial of intention to harm herself. She did not have any significant cardiac arrhythmias or electrolyte disturbances. She was stable for discharge within two days of admission. The inpatient admission was not medically necessary for this patient. Inpatient care is necessary when the patientas signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting, when the
patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Therefore, acute inpatient services provided from 8/24/20 through 8/26/20 were not medically necessary for the treatment of this patient.
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A 19-year-old male enrollee has requested reimbursement for procedure codes 86671 x 2 and 86021 x 3 performed on 2/14/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
that this patient had symptoms concerning for inflammatory bowel disease, and has a diagnosis of ulcerative colitis. He was taking azathioprine, a therapy with significant potential adverse effects, and biologic therapy, which has serious
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Upheld
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Experimental
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Summary Reviewer 3
A 19-year-old male enrollee has requested reimbursement for procedure codes 86671 x 2 and 86021 x 3 performed on 2/14/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient had symptoms concerning for inflammatory bowel disease, and has a diagnosis of ulcerative colitis. He was taking azathioprine, a therapy with significant potential adverse effects, and biologic therapy, which has serious potential adverse effects, was being contemplated. Therefore, definitive diagnosis of inflammatory bowel disease was necessary in this case. However, the American Gastroenterological Association guidelines and the American College of Gastroenterology guidelines for ulcerative colitis do not recommend the use of anti-Saccharomyces cerevisiae antibody (ASCA, CPT 86671) and anti-neutrophil cytoplasmic antibody (ANCA, CPT 86021) testing, or any other antibody testing, for diagnosis or management of ulcerative colitis. The American College of Gastroenterology guidelines specifically state that apooled sensitivity of antibody testing for diagnosis of ulcerative colitis is low, and such markers are not used for establishing or ruling out a diagnosis of ulcerative colitis.a American College of Gastroenterology guidelines for Crohnas disease do not recommend the tests either. Therefore, procedure codes 86671 x 2 and 86021 x 3 performed on 2/14/20 were not likely to have been more beneficial than other available standard therapy.
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A 45-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 45-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. The guidelines recommend that treatment-naive genotype 1a patients should be treated with Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C, genotype 1 regardless of fibrosis stage. For these reasons, the requested treatment with Harvoni for 12 weeks is supported as medically necessary for the treatment of this patients hepatitis C infection. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 64-year-old male insured has requested reimbursement for laboratory testing performed on
5/13/22. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insureds acute deep vein thrombosis (DVT).
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Upheld
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Experimental
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Summary Reviewer 2
A 64-year-old male insured has requested reimbursement for laboratory testing performed on
5/13/22. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insureds acute deep vein thrombosis (DVT). The
physician reviewer found that deep vein thrombosis and pulmonary embolism may be caused by
hereditary thrombophilias. The increased risk is worth knowing especially in situations of
prolonged immobility such as surgery, long car trips, or long airplane flights. These complications
may be prevented by appropriate interventions and the avoidance of certain drugs which are
prothrombic. There are several known genetic factors that can cause thrombophilia. The
G20210A mutation increases risk of deep vein thrombosis about three-fold but nearly 20-fold in
compound heterozygous patients with Factor V Leiden. Similarly, patients with
hyperhomocysteinemia and Factor V Leiden are at increased risk for deep vein thrombosis. In
this case, the patient underwent Factor V Leiden genetic testing, which was likely to be more
beneficial than an activated Protein C resistance assay, which is complicated and can result in
spurious results (Kadauke, et al.; Exner, et al.). Thus, the genetic testing performed in this
patients work-up for hypercoagulable states was appropriate. All told, the laboratory testing
performed on 5/13/22 was likely to be more beneficial for evaluation of the patients medical
condition than any available standard therapy.
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patient is a 53-year-old female with a history of primary melanoma of the cervix with an
erythroblastic oncogene B (ERBB)2 V777L mutation. In a letter dated 12/13/22, the provider
reported that the patient was diagnosed in April 2022. The records noted that the patient had
undergone initial treatment with four cycles of ipilimumab with nivolumab. The Health Insurer
has denied the requested medication as not medically necessary.
that the records document that this patient
presents with a history of primary melanoma of the cervix with an erythroblastic oncogene B
(ERBB)2 V777L mutation. The patients provider has recommended treatment with Tukysa.
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Upheld
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Medical Necessity
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Summary
The patient is a 53-year-old female with a history of primary melanoma of the cervix with an
erythroblastic oncogene B (ERBB)2 V777L mutation. In a letter dated 12/13/22, the provider
reported that the patient was diagnosed in April 2022. The records noted that the patient had
undergone initial treatment with four cycles of ipilimumab with nivolumab. The Health Insurer
has denied the requested medication as not medically necessary. This denial is the subject of this
appeal and determination. The physician reviewer found that the records document that this patient
presents with a history of primary melanoma of the cervix with an erythroblastic oncogene B
(ERBB)2 V777L mutation. The patients provider has recommended treatment with Tukysa. Per
the National Comprehensive Cancer Network (NCCN) guidelines for melanoma, mucosal
melanoma should be treated as diseases distinct from cutaneous melanoma, with care tailored to
the individual patient. The U.S. Food and Drug Administration (FDA) has approved Tukysa for
the treatment of patients with HER2 positive breast cancer or HER2 positive colon cancer, to be
taken in combination with other agents. However, there is a lack of FDA approved indication or
support for use of Tukysa for use as monotherapy in the treatment of this patients cancer. Strickler
and colleagues reported that studies are ongoing to evaluate the efficacy of Tukysa as monotherapy
and to validate the reported findings from their trial. Overall, there is a lack of data to suggest that
Tukysa as single agent therapy is safe and effective in this patients clinical setting. All told, the
requested Tukysa (tucatinib) 150 mg #120/30 days is not medically necessary for treatment of this
patient.
| 1 |
The patient is a 28-year-old female who presented to her provider on 12/27/22. The patient has
requested reimbursement for knee orthosis on 12/27/22. The Health Insurer has denied this
request and reported that the equipment at issue was not medically necessary for the treatment
of this patient.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 28-year-old female who presented to her provider on 12/27/22. The patient has
requested reimbursement for knee orthosis on 12/27/22. The Health Insurer has denied this
request and reported that the equipment at issue was not medically necessary for the treatment
of this patient. The physician reviewer found that the submitted documentation does not support
the medical necessity of the equipment at issue. The use of functional ACL bracing following ACL
reconstruction has been debated over the past several years. In a systematic review of functional
bracing after ACL reconstruction, Lowe and colleagues report, The effectiveness of
postoperative functional bracing following ACL reconstruction remains elusive. Some data
suggest that functional bracing may have some benefit with regard to in vivo knee kinematics
and may offer increased protection of the implanted graft after ACL reconstruction without
sacrificing function, range of motion, or proprioception. However, limited evidence exists
supporting the use of routine functional bracing to decrease the rate of reinjury after ACL
reconstruction. Smith and colleagues conclude, Biomechanical and clinical evidence suggests
current functional bracing technologies do not sufficiently restore normal biomechanics to the
ACL-deficient knee, protect the reconstructed ACL, and improve long-term patient outcomes.
Yang and colleagues note, Knee bracing does not appear to improve the clinical outcomes on
the function and stability for ACL-reconstructed knees. Thus, bracing for patients treated with
ACL reconstruction should not be recommended routinely. Andrade and colleagues report,
Immediate knee mobilisation and strength/neuromuscular training should be used. Continuous
passive motion and functional bracing should be eschewed. Given that current medical
literature does not recommend continued passive motion and post-operative bracing, the
equipment at issue was not medically indicated. Therefore, knee orthosis on 12/27/22 was not
medically necessary for the treatment of this patient.
| 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.
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Overturned
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Experimental
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Summary Reviewer 2
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 in this circumstance, there is potential for recovery of left ventricular function over time with medical therapy. There was no documented indication for immediate placement of a defibrillator, such as sustained or inducible ventricular tachycardia, unexplained syncope or aborted sudden cardiac arrest. Placement of a prophylactic defibrillator is not recommended until a period of time greater than 90 days where continued left ventricular dysfunction is documented to persist despite appropriate treatment. A prophylactic defibrillator (wearable or implantable) before this time has not been demonstrated to improve outcome. Recent retrospective trials in patients with newly diagnosed non-ischemic cardiomyopathy have not demonstrated benefit with prophylactic wearable defibrillators. At this time, prophylactic wearable external defibrillator would be indicated only if accepted criteria for an implantable defibrillator were met and an implantable defibrillator could not be placed, needed to be significantly delayed or required explantation. In sum, the wearable cardioverter defibrillator provided on 1/24/19 was not likely to have been superior over other treatment options.
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