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A 24-year-old female enrollee has requested reimbursement for 83993 (fecal calprotectin) provided on 1/30/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of diarrhea.
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Upheld
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Experimental
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Summary Reviewer 3
A 24-year-old female enrollee has requested reimbursement for 83993 (fecal calprotectin) provided on 1/30/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of diarrhea. The physician reviewer found that Fecal calprotectin is often ordered to determine whether inflammation (disease activity), such as inflammatory bowel disease, is present as a cause for gastrointestinal symptoms such as diarrhea. A meta-analysis by Van Rheenen and colleagues found that up to 11% of adults with inflammatory bowel disease may be misclassified as having noninflammatory disease, such as irritable bowel syndrome. As a rule-out test, this is not sufficient. The use of calprotectin to diagnose change in bowel habits has not been subsequently accepted. The impact of this testing on management and its appropriateness in guiding therapy decisions in patients with unexplained diarrhea has not been demonstrated. The findings can be redundant with standard methods of diagnosis, such as colonoscopy or sigmoidoscopy, or other serum markers of inflammation. Guidelines on the diagnosis and management of diarrhea do not recommend calprotectin as part of the investigation. Furthermore, clinical studies do not support a standardized action, such as empiric use of antibiotics or empiric therapy for inflammatory bowel disease, for a positive result. For these reasons, 83993 (fecal calprotectin) provided on 1/30/18 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 64-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 2/1/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 64-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 2/1/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the American College of Radiology (ACR) has urged tomosynthesis be removed from the investigational category due to the advantages it brings to radiologists interpreting mammograms especially in patients with extremely or heterogeneously dense tissue such as the patient in this case. Tomosynthesis allows radiologists to separate dense glandular elements from underlying mass and architectural distortion resulting in a decrease in callbacks and increase in detection of small cancers. Thus, the addition of tomosynthesis to the usual two-dimensional imaging protocol was likely of greater benefit to this patient than had her exam been done with two-dimensional imaging alone. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 61-year-old female enrollee has requested authorization and coverage for Forteo pen injector 20 mcg per dose 600 mcg/2.4 mL. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees osteoporosis.
has sustained repeated fractures while on bisphosphonate therapy,
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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 Forteo pen injector 20 mcg per dose 600 mcg/2.4 mL. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees osteoporosis. The physician reviewer found that Osteoporosis is an increasingly widespread condition, affecting more than one half of patients ages 50 and older. Of these, approximately 80% are women. Fractures are the most dangerous aspect of osteoporosis (Old and Calvert). Until recently, pharmacological options for the treatment of osteoporosis have been limited to antiresorptive agents, including the oral bisphosphonates. Newer treatment agents have become available over the past few years, including Forteo, which was initially approved for treatment of osteoporosis in 2002. Forteo is a recombinant form of the biologically active component of parathyroid hormone which has been shown to increase bone mass and prevent fractures in osteoporotic bone (Drake, et al). Recent data has demonstrated that Forteo may aid in the healing of fractures and non-unions in osteoporotic patients (Babu, et al). Forteo is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Since this patient has sustained repeated fractures while on bisphosphonate therapy, the requested Forteo pen injector 20 mcg per dose 600 mcg/2.4 mL is medically necessary for treatment of her osteoporosis. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 37-year-old male enrollee has requested reimbursement for laboratory testing performed on
6/05/20. The Health Insurer has denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 37-year-old male enrollee has requested reimbursement for laboratory testing performed on
6/05/20. The Health Insurer has denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition. The physician reviewer
found that according to National Comprehensive Cancer Network (NCCN) guidelines, assessment
of peripheral blood involvement optimally by flow cytometry is important for staging and is also
useful to differentiate cutaneous T-cell lymphoma with peripheral blood involvement from other
forms of leukemic T-cell lymphomas. Flow cytometry allows for the assessment of a population
of expanded CD4+ cells with abnormal immunophenotype. Since this is a rare disease,
investigation into the tissue and blood needs to be performed to be able to direct optimal
treatment. If there is clonality in the peripheral smear, then the treatment will be directed
systemically, not just to the skin. There is no other test that will be more beneficial at the current
time to help stage the systemic component of mycosis fungoides. Therefore, laboratory testing
performed on 6/05/20 was likely to have been more beneficial than any available standard
therapy.
| 0 |
A 45-year-old male enrollee has requested authorization and coverage for powered upper extremity range of motion assist device, elbow, wrist, hand and finger. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 45-year-old male enrollee has requested authorization and coverage for powered upper extremity range of motion assist device, elbow, wrist, hand and finger. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that current quality evidence shows that the use of the myoelectric elbow-wrist-hand orthosis increases gross manual dexterity, increases the quality of task performance and enables subjects to grasp objects like a cup significantly faster. Myoelectric elbow-wrist-hand orthosis facilitates clinically meaningful increases in functional task performance. Moderately impaired stroke survivors exhibit severely diminished ability to incorporate their affected upper extremities into daily activities and subsequently have limited treatment options. This limitation often necessitates prescription of compensatory strategies and/or assistive devices to facilitate independence, with limited involvement from the paretic upper extremity, making many activities extremely difficult. In contrast, current evidence supports that paretic arm disability may be significantly reduced while wearing a myoelectric elbow-wrist-hand orthosis, allowing for immediate use of the paretic arm and hand with little device training. Therefore, the requested powered upper extremity range of motion assist device, elbow, wrist, hand and finger is likely to be more beneficial than other methods of evaluating this patient.
| 1 |
A 66-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 8/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung adenocarcinoma.
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Overturned
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Experimental
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Summary Reviewer 1
A 66-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 8/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung adenocarcinoma. The physician reviewer found that Adenocarcinoma of the lung should be tested for certain molecular abnormalities, including ALK, EGFR and ROS-1. Each of these has a therapeutic implication. In this case, EGFR and ALK testing were done on the initial tissue biopsy, so it is not necessary to check these on Guardant360 assay. The other use of Guardant360 assay is to look for a target at which therapy can be directed. Thus far, such use has not been shown to be clinically beneficial for the vast majority of patients. A randomized study by Le Tourneau and colleagues failed to demonstrate that choosing therapy based on molecular profiling was superior to choosing therapy based on conventional judgment. Therefore, Guardant360 testing was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 34-year-old female enrollee has requested reimbursement for homocysteine testing performed on 6/10/20 and 9/23/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue.
this case, the patient has a history of Hashimotos thyroid disease. In October 2019, she had comprehensive testing showing normal B12, folate and homocysteine levels.
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Upheld
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Experimental
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Summary Reviewer 1
A 34-year-old female enrollee has requested reimbursement for homocysteine testing performed on 6/10/20 and 9/23/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. At issue is whether the services at issue were likely to have been more beneficial for evaluation of the enrollees condition than any available standard therapy. The physician reviewer found that Hyperhomocysteinemia has been associated with vascular disease, venous thromboembolism, obstetric complications, osteoporosis, dementia and cognitive impairment in Parkinsons disease. Homocysteine levels are generally measured if an individual is suspected of having homocystinuria. Lowering homocysteine levels has not been shown to prevent cardiovascular events, prevent dementia or decrease thrombotic events. Some individuals with Hashimotos thyroid disease have an undiagnosed mutation in the MTHFR gene, causing high homocysteine levels. However, routine testing of homocysteine levels is not recommended, as treatment of this disorder has not shown to decrease the incidence of thrombosis or cardiovascular events. In this case, the patient has a history of Hashimotos thyroid disease. In October 2019, she had comprehensive testing showing normal B12, folate and homocysteine levels. There is a lack of support for repeat homocysteine testing in this setting. Therefore, homocysteine testing performed on 6/10/20 and 9/23/20 was not likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
A 53-year-old female enrollee has requested authorization and coverage for Nerlynx 40 mg. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 53-year-old female enrollee has requested authorization and coverage for Nerlynx 40 mg. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that Neratinib (Nerlynx) is U.S. Food and Drug Administration (FDA) approved for extended adjuvant treatment (as a single agent) of early-stage HER2 positive breast cancer (following adjuvant trastuzumab-based therapy). Neratinib has demonstrated improvements in recurrence rates when used in the adjuvant setting following treatment with single-agent trastuzumab, particularly in patients with HER2 positive tumors that are larger and estrogen receptor positive. There is a lack of data on the safety or efficacy of neratinib in patients whose adjuvant therapy included pertuzumab (Perjeta). The use of neratinib following adjuvant trastuzumab is usually limited to higher-risk (by stage), HER2 positive breast cancers. There is a lack of data for the benefit of neratinib in women who have received pertuzumab or T-DM1 as part of their neoadjuvant treatments. Use of neratinib in this setting is not supported by the National Comprehensive Cancer Network and is not considered a standard of care. This patient received pertuzumab in both the neoadjuvant and adjuvant setting. Therefore, Nerlynx 40 mg is not medically necessary for the treatment of this patient.
| 1 |
A 58-year-old male enrollee has requested authorization and coverage for proton beam radiation
therapy (PBT). The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees locally advanced esophagus cancer.
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Overturned
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Experimental
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Summary Reviewer 1
A 58-year-old male enrollee has requested authorization and coverage for proton beam radiation
therapy (PBT). The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees locally advanced esophagus cancer. The physician
reviewer found that PBT is likely to be more beneficial for treatment of the patients condition than any
available standard therapy.
| 1 |
patient is a 45-year-old male who presented with a seizure in 2022. The patient has
requested authorization and coverage for proton beam therapy.
In this case, the patients brain tumor invades into the brain stem and hippocampus.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 45-year-old male who presented with a seizure in 2022. The patient has
requested authorization and coverage for proton beam therapy. The physician reviewer found
that guidelines do not endorse the routine use of proton therapy in the treatment of brain
tumors. In this case, the patients brain tumor invades into the brain stem and hippocampus.
Proton therapy is absent of the low dose bath associated with conventional treatment using
photon techniques and is able to limit the integral radiation dose compared to treatment with
photons. The comparative planning submitted shows a significant reduction in the dose the brain
stem and hippocampus using proton therapy. Treatment with protons would be expected to be
associated with less neurocognitive toxicities compared to standard treatment with photons.
Therefore, the requested proton beam therapy is medically necessary for the treatment of this
patient.
| 1 |
A 55-year-old male has requested reimbursement for high-intensity focused ultrasound performed on 8/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees prostate cancer.
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Upheld
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Experimental
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Summary Reviewer 3
A 55-year-old male has requested reimbursement for high-intensity focused ultrasound performed on 8/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that high-intensity focused ultrasound therapy for prostate cancer is a relatively new procedure. The U.S. Food and Drug Administration (FDA) has approved this procedure to be safe for the treatment of prostate ablation. However, there is no specific indication for the treatment of prostate cancer. The safety and efficacy of this treatment is currently being evaluated. The medical evidence has not demonstrated that this form of treatment is superior to conventional treatment options. Thus, high-intensity focused ultrasound performed on 8/14/17 was not likely to have been of greater benefit than other treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 60-year-old female enrollee has requested authorization and coverage for 22870 and 22869 (insertion of stabilization device without compression). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
the records document lumbar spinal stenosis with moderate to severe leg, buttock, groin, and back pain, sensory and motor dysfunction, and evidence of neurogenic claudication. She has tried and failed over six months of conservative treatment. The provider has advised a minimally invasive surgery consisting of insertion of a Superion interspinous process stabilization spacer,
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Upheld
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Experimental
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Summary Reviewer 3
A 60-year-old female enrollee has requested authorization and coverage for 22870 and 22869 (insertion of stabilization device without compression). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the records document lumbar spinal stenosis with moderate to severe leg, buttock, groin, and back pain, sensory and motor dysfunction, and evidence of neurogenic claudication. She has tried and failed over six months of conservative treatment. The provider has advised a minimally invasive surgery consisting of insertion of a Superion interspinous process stabilization spacer, which is a less invasive indirect decompression procedure for patients who fail conservative treatment before undergoing a laminectomy and fusion. The patient is an appropriate candidate for this minimally invasive surgery. There are several treatment options for patients with lumbar spinal stenosis. These include the traditional invasive lumbar decompression and fusion and continued conservative care. When conservative care is not effective, the interspinous spacer decompression using the Superion device offers a minimally invasive procedure with documented good results for patients who fail conservative treatment. The Superion interspinous lumbar decompression is a minimally invasive, low-risk procedure for the treatment of lumbar spinal stenosis, which is safe and effective by maintaining sagittal alignment of the vertebrae at that level. This limits the possibility of device dislodgment or migration, and preserves the mobility and structural integrity of the spine. Thus, the requested CPT codes 22869 and 22870 (insertion of stabilization device without decompression) are likely to be more beneficial for treatment of the patients medical condition than any standard therapy.
| 1 |
The patient is a 57-year-old male with a history of recurrent palpitations over approximately an eight year period. The episodes are infrequent but typically are relieved with a Valsalva maneuver. He has had approximately four or five episodes over the previous year when he was seen in April 2017. Per the medical record provided, the patient had ambulatory electrocardiogram (ECG) monitoring, which was unsuccessful in diagnosing the clinical arrhythmia. An echocardiogram performed on 4/14/17 demonstrated normal left ventricular function, no gross valvular abnormalities and mild mitral regurgitation by Doppler. On 9/20/17, a comprehensive electrophysiological study was performed, which demonstrated a dual abnormal atrioventricular (AV) node physiology, induction of non-s
. An implantable loop monitor was inserted following the electrophysiology study. The patient has requested reimbursement for implantable event recorder inserted on 9/20/17. The Health Insurer has denied this request for reimbursement. Per the Health Insurer, the procedure at issue was investigational for treating this patients medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
The patient is a 57-year-old male with a history of recurrent palpitations over approximately an eight year period. The episodes are infrequent but typically are relieved with a Valsalva maneuver. He has had approximately four or five episodes over the previous year when he was seen in April 2017. Per the medical record provided, the patient had ambulatory electrocardiogram (ECG) monitoring, which was unsuccessful in diagnosing the clinical arrhythmia. An echocardiogram performed on 4/14/17 demonstrated normal left ventricular function, no gross valvular abnormalities and mild mitral regurgitation by Doppler. On 9/20/17, a comprehensive electrophysiological study was performed, which demonstrated a dual abnormal atrioventricular (AV) node physiology, induction of non-sustained AV node reentrant tachycardia, inducible non-sustained atrial tachycardia and no inducible ventricular tachyarrhythmias. However, the patients clinical arrhythmia could not be induced. An implantable loop monitor was inserted following the electrophysiology study. The patient has requested reimbursement for implantable event recorder inserted on 9/20/17. The Health Insurer has denied this request for reimbursement. Per the Health Insurer, the procedure at issue was investigational for treating this patients medical condition. In the study by Giada and colleagues, patients with symptoms of palpitations and without severe structural heart disease, a diagnosis of the clinical arrhythmia was significantly more likely with the use of an implantable loop monitor than with a conventional strategy. The patient has had recurrent significant palpitations suggestive of a supraventricular tachycardia with associated lightheadedness over several years. Conventional ambulatory monitoring did not yield a diagnosis. The treatment strategy in this case involved identifying the specific arrhythmia followed by treatment with radiofrequency ablation. In this patients case, the use of an implantable loop monitor allowed the best opportunity for a definitive diagnosis. As such, the implantable event recorder inserted on 9/20/17 was likely to have been more effective than the conventional diagnostic strategy for the evaluation of this patients medical condition. Based upon the information set forth above, the procedure at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 12-year-old male who presented for a sleep study on 3/29/21. The patients parent
has requested authorization and coverage for Inspire Hypoglossal Nerve Stimulator. The Health
Insurer has denied this request and reported that the requested services are not medically necessary
for the treatment of this patient.
The patient has a history of trisomy 21 and severe obstructive
sleep apnea in the setting of post-adenotonsillectomy. His apnea-hypopnea index (AHI) score was
17. The patients primary issue is the large tongue base, and he is reportedly non-compliant with
CPAP secondary to sensory issues related to Down syndrome. According
spire Upper Airway Stimulation device was given a premarket
approval, dated April 14, 2020,
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 12-year-old male who presented for a sleep study on 3/29/21. The patients parent
has requested authorization and coverage for Inspire Hypoglossal Nerve Stimulator. The Health
Insurer has denied this request and reported that the requested services are not medically necessary
for the treatment of this patient. This denial is the subject of this appeal and determination. The
physician reviewer found that the submitted documentation fails to demonstrate the medical
necessity of the requested services. The patient has a history of trisomy 21 and severe obstructive
sleep apnea in the setting of post-adenotonsillectomy. His apnea-hypopnea index (AHI) score was
17. The patients primary issue is the large tongue base, and he is reportedly non-compliant with
CPAP secondary to sensory issues related to Down syndrome. According to the U.S. Food and
Drug Administration (FDA), the Inspire Upper Airway Stimulation device was given a premarket
approval, dated April 14, 2020, expanding the indications for this device to adolescents aged 18 to
21. Inspire UAS is indicated for use in patients between the ages of 18 and 21 with moderate to
severe OSA who: do not have complete concentric collapse at the soft palate level; are
contraindicated for, or not effectively treated by, adenotonsillectomy; have been confirmed to fail,
or cannot tolerate, positive airway pressure (PAP) therapy despite attempts to improve compliance;
and have followed standard of care in considering all other alternative/adjunct therapies.
Otherwise, this device is only FDA-approved in adults. A number of recent small case studies, and
one small trial, have shown that the treatment of OSA with hypoglossal nerve stimulation in Down
syndrome patients does have promise and is generally tolerated. However, Amaddeo and
colleagues noted that although this treatment has been shown to be effective in adults with OSA
and no obesity or circumferential velopharynx collapse, information on long-term follow-up is
lacking for the adolescent Down syndrome population for which this treatment is proposed.
Likewise, a very recent systematic review by Gounden and Chawla, reviewing the management of
OSA in Down syndrome post-adenotonsillectomy, found, The most optimal treatment for the
management of residual obstructive sleep apnea remains uncertain. There are various treatment
options described in the literature, however, they have not been thoroughly studied, with only eight
relevant articles found. Studies comparing outcomes following different treatment interventions
and using consistent parameters are required to gain further understanding of the most optimal
treatment for residual obstructive sleep apnea in this population. While this patient does meet
most of the FDA indications for this device, he does not meet the age requirement. This device is
approved only for those aged 18 and older. In addition, the recent systematic review by Gounden
and Chawla emphasized that the optimal treatment for OSA, including hypoglossal nerve
stimulation, in this Down syndrome pediatric population is unknown. Both the lack of FDA
approval in this age category and the lack of large-scale trials supporting this treatment in this
population remain relevant in the determination of this case. As such, the requested Inspire
Hypoglossal Nerve Stimulator is not medically necessary for the treatment of this patient.
| 1 |
A 61-year-old female enrollee has requested reimbursement for the in-office surgical injections performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees lumbar spondylosis with arthropathy.
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Upheld
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Experimental
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Summary Reviewer 3
A 61-year-old female enrollee has requested reimbursement for the in-office surgical injections performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees lumbar spondylosis with arthropathy. The physician reviewer found that in the documentation available for review, there is a lack of radiographic evidence of facet arthropathy at the L5-S1 location. In addition, it is unclear why the procedure was performed with steroids. The current peer-reviewed medical literature requires medial branch blocks to be performed using either solely lidocaine or bupivacaine and require a pain diary for the day to verify when the local anesthetic wore off for medial branch blocks (Manchikanti, et al). Further, these injections are not to be performed when patients have significant radicular pain. Finally, there is a lack of documentation of a home exercise program, physical therapy or other conservative, non-invasive and non-pharmacological, treatment options. Thus, the in-office surgical injections provided on 8/4/15 were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 62-year-old male enrollee has requested has requested authorization and coverage for Sovaldi. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus.
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Overturned
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Medical Necessity
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Summary Reviewer
A 62-year-old male enrollee has requested has requested authorization and coverage for Sovaldi. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found that according to the joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. Re-treatment is supported by the presence of diabetes mellitus, which is associated with rapid progression of fibrosis per the guidelines. In patients who have failed an NS5A inhibitor such as Harvoni, testing for NS3 and NS5A resistance-associated variants is recommended. In patients with both NS3 and NS5A resistance-associated variants, retreatment is recommended with Sovaldi, Zepatier, and ribavirin for 12 weeks, based on a 100% cure rate in the C-SWIFT study using this regimen (Lawitz, et al). The guidelines cite data showing decreased survival with delay in therapy (Jezequel, et al). For these reasons, the requested treatment with Sovaldi, to be used with Zepatier and ribavirin for 12 weeks is 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.
| 1 |
patient is a 15-year-old male who has been diagnosed with growth hormone deficiency.
The patients parent has requested authorization and coverage for Norditropin Flexpro 15
mg/1.5 ml pen injector.
. On 5/26/21, this patient met the auxologic criterion for
growth hormone deficiency of one-year height
.
On 7/07/21, he met the diagnostic criteria for growth hormone deficiency by failing two
standard growth hormone provocative tests with L-arginine and clonidine.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 15-year-old male who has been diagnosed with growth hormone deficiency.
The patients parent has requested authorization and coverage for Norditropin Flexpro 15
mg/1.5 ml pen injector. The physician reviewer found that Somatotropin therapy, such as
Norditropin Flexpro 15 mg/1.5 ml pen injector, is medically necessary for the treatment of
growth hormone deficiency in children. On 5/26/21, this patient met the auxologic criterion for
growth hormone deficiency of one-year height velocity Z-score below -2 for chronological age.
On 7/07/21, he met the diagnostic criteria for growth hormone deficiency by failing two
standard growth hormone provocative tests with L-arginine and clonidine. Standard of care for
evaluation of pediatric short stature includes direct measurements of parental heights.
Nevertheless, his predicted adult height by the Bayley-Pinneau method based on the height
observed on 5/26/21 was significantly lower than (more than one standard deviation below)
the mid-parental target height. Therefore, Norditropin Flexpro 15 mg/1.5 ml pen injector is
medically necessary for the treatment of this patient.
| 1 |
A 31-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/18/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 31-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/18/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient has an early stage melanoma. Commercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. Therefore, DecisionDx-Melanoma testing performed on 12/18/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 57-year-old male enrollee has requested reimbursement for Oncotype DX testing Prostate Cancer Assay provided on 9/15/15. The Health Plan has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees elevated prostate specific antigen (PSA).
, the patient has low-risk localized prostate cancer and the testing at issue was indicated to
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Overturned
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Experimental
|
Summary Reviewer 1
A 57-year-old male enrollee has requested reimbursement for Oncotype DX testing Prostate Cancer Assay provided on 9/15/15. The Health Plan has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees elevated prostate specific antigen (PSA). The physician reviewer found THE testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. There is sufficient support in the peer-reviewed literature for the testing at issue in this clinical setting. Several tissue-based molecular assays have been developed in an effort to improve decision-making in newly diagnosed patients considering active surveillance and in treated men considering adjuvant therapy or treatment for recurrence. Patients with clinically localized disease may consider the use of tumor-based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of National Comprehensive Cancer Network (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. In this case, the patient has low-risk localized prostate cancer and the testing at issue was indicated to assist with improve decision-making. All told, the Oncotype DX testing provided on 9/15/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 53-year-old female has requested reimbursement for advanced lipoprotein testing. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
In this patients case, she was already on statin therapy for elevated cholesterol.
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Upheld
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Experimental
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Summary Reviewer 3
A 53-year-old female has requested reimbursement for advanced lipoprotein testing. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current guidelines do not recommend routine use of advanced lipoprotein tests, mainly because it is unclear how much incremental prognostic information is provided by these tests beyond that available from a standard lipid panel. To date, the most useful measures obtained from lipoprotein tests relate to atherogenic particle number. However, at this time, non-high-density lipoprotein (HDL) cholesterol or the total/HDL cholesterol ratio is of comparable predictive strength. Low-density lipoprotein (LDL) sub-fractions measurement may provide some information regarding risk, but whether this is incremental beyond the current standard of care is unclear. In this patients case, she was already on statin therapy for elevated cholesterol. As such, and given the other known baseline coronary risk factors (hypertension, hyperlipidemia, prediabetes), there is no additional diagnostic or prognostic information to be gleaned by the testing at issue. Thus, advanced lipoprotein testing performed on 3/15/16 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 60-year-old male enrollee has requested reimbursement for chiropractic services including CPT codes 97110, 97032, 97140 and 99214 provided on 6/1/17, 6/8/17, 6/15/17, 8/14/17, and 9/7/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees spondylosis without myelopathy/radiculopathy of the cervical region.
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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 reimbursement for chiropractic services including CPT codes 97110, 97032, 97140 and 99214 provided on 6/1/17, 6/8/17, 6/15/17, 8/14/17, and 9/7/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees spondylosis without myelopathy/radiculopathy of the cervical region. The physician reviewer found that the provided documentation does not establish the medical necessity of the chiropractic services provided from 6/1/17 through 9/7/17. Specifically, the records do not objectively verify functional improvements with prior chiropractic therapy over eight weeks of care. As noted in the current medical literature and guidelines, the documentation should report objective functional improvement with chiropractic treatment to support an indication for future services. Accordingly, the chiropractic services including CPT codes 97110, 97032, 97140 and 99214 provided on 6/1/17, 6/8/17, 6/15/17, 8/14/17, and 9/7/17 were not medically necessary for treatment of this patients neck pain and low back pain. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 36-year-old female with abnormal uterine bleeding. She reported heavy menstrual cycles with cramping affecting her quality of life. She tried hormonal options for medical management with birth control pills in November 2016, but experienced headaches. A pelvic ultrasound was performed showing no intracavitary abnormalities. On 12/30/16, endometrial ablation was performed. The Health Insurer has denied reimbursement for the services at issue. Per the Health Insurer, endometrial ablation was investigational for the treatment of this patient.
the duration of her symptoms. The patient no longer desired fertility. She trialed a course of hormonal management with oral contraceptives
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Upheld
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Experimental
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Summary Reviewer 3
The patient is a 36-year-old female with abnormal uterine bleeding. She reported heavy menstrual cycles with cramping affecting her quality of life. She tried hormonal options for medical management with birth control pills in November 2016, but experienced headaches. A pelvic ultrasound was performed showing no intracavitary abnormalities. On 12/30/16, endometrial ablation was performed. The Health Insurer has denied reimbursement for the services at issue. Per the Health Insurer, endometrial ablation was investigational for the treatment of this patient. The medical evidence does not support the services at issue in this clinical setting. An endometrial ablation is a minimally invasive technique used to destroy the uterine lining for the treatment of chronic menorrhagia/abnormal uterine bleeding. This technique is supported by peer-reviewed current medical literature in patients who no longer desire fertility and in whom a thorough work-up has been performed to rule out other causes of abnormal uterine bleeding. This evaluation includes performing a pelvic ultrasound and an endometrial biopsy or dilation and curettage (D&C). Furthermore, the patient should have tried and failed medical management options over a reasonable period of time. Alternative treatment options, including hormones (pills, intrauterine device) and surgery, should be discussed and documented in the medical records. In this patients case, there was a lack of clinical documentation regarding the duration of her symptoms. The patient no longer desired fertility. She trialed a course of hormonal management with oral contraceptives, although, the overall duration of this treatment and failure is not clearly documented. Additionally, there is no documentation to support an evaluation of her endometrial lining to rule out endometrial hyperplasia or malignancy by biopsy or D&C. Finally, there is no clinical documentation to support a discussion of all her options prior to proceeding with endometrial ablation. Thus, endometrial ablation performed on 12/30/16 was not likely to have been more efficacious than other available treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 23-year-old male enrollee has requested authorization and coverage for powered robotic lower body exoskeleton system. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 23-year-old male enrollee has requested authorization and coverage for powered robotic lower body exoskeleton system. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of the enrolleeas medical condition. The physician reviewer found that the published evidence indicates that the powered exoskeletal ambulatory assistance devices that are currently commercially available are not an efficient, reliable or practical means of mobility for persons with paraplegia and other neurological disorders who seek upright ambulation. This type of device is associated with high feasibility challenges and has not met usersa high expectations of benefits. Therapist or caregiver/companion supervision and assistance are almost always required for safety and sometimes for physical assistance. Environmental barriers, such as curbs/stairs/steps, and differing surfaces remain challenges. In fact, walking in any pattern outside of a straight line on a flat and level surface can be challenging. The devices, overall, fail to promote a general increase in user independence in everyday life contexts, and in fact can be more disabling than enabling. There are, more importantly, multiple risks associated with use of this device as a mobility device outside of very controlled environments such as a physical therapy gym, including but not limited to, the risk of falls and the risk of becoming stranded (due to mechanical failure, loss of power, etc.). The risk of accidents while using these types of devices in highly dynamic environments cohabitated by other humans and machines remains particularly understudied. Current screening protocols for fracture risk, such as tolerance for standing on a passive stander or DEXA bone densitometry testing, appear to remain inadequate to screen out individuals who develop fragility fractures due to use of these types of devices. There is no proven health benefit of standing and intermittent passive walking using an externally powered exoskeleton to passively move the lower limbs to favorably balance out the risks of using these types of devices. Standard of care for achieving appropriate levels of cardiovascular and musculoskeletal exercise in the setting of this patientas condition would be performing regular physical activity using volitionally active musculature, including, but not limited to, propulsion of a manual wheelchair, wheelchair sports and other adaptive sports/exercise activities. There is no expected health benefit of standing and ambulation using an externally powered exoskeletal device over natural, self-powered activity and exercise. The reported health benefits discussed in papers published with industry support are subjective in nature and have not been demonstrated in a scientifically rigorous manner. On balance, the increased exposure to potential adverse sequelae with use of the device under review is unnecessary given the lack of proven benefits and given that a much more established, reliable, efficient, useful and safe means of mobility and tool for active exercise is readily available, i.e., a wheelchair, which would represent readily available standard therapy for this patientas condition. The requested device is not likely to be more beneficial for treatment of the patientas health than standard treatment, which would include a properly fitted manual wheelchair and active cardiovascular and musculoskeletal exercises using volitionally intact motor function. Therefore, the requested powered robotic lower body exoskeleton system is not likely to be more beneficial than other available standard therapy.
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A 48-year-old female enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 4/28/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer.
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Overturned
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Experimental
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Summary Reviewer 3
A 48-year-old female enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 4/28/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found the medical evidence shows that adjuvant chemotherapy confers a survival advantage for patients with stage III colorectal cancer, but not for those with stage II disease. Meta-analyses have not shown any survival advantage for 5-FU/leucovorin treatment in stage II patients. The reasons for this conclusion are complex. Stage II patients do well after surgery alone, so that the magnitude of the survival benefit conferred by adjuvant chemotherapy is small. Additionally, randomized clinical trials to date have had too few stage II patients to discern a statistically significant advantage. In contrast, the benefit for stage III patients is quite significant, and it is likely that stage II patients benefit as well. Therefore, subset analyses to identify those patients with prognostic features that may predict for chemotherapy benefit have been analyzed. For example, oncologists consider adjuvant treatment for those stage II patients with T4 disease, obstructing lesions, and other biomarkers. The Oncotype DX Colon Cancer Assay uses a reverse transcriptase-polymerase chain reaction assay for 12 genes in an algorithm that can be used to predict recurrence. The medical evidence for the test is sufficient to allow its use to estimate the risk of recurrence for stage II patients when incorporated with other tests, such as standard pathology and microsatellite instability testing. Thus, Oncotype DX Colon Cancer Assay performed on 4/28/16 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 54-year-old female enrollee has requested authorization and coverage for spine surgeries. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the treatment of the enrollees medical condition.
This patient presents with severe neck pain radiating into the right upper extremity with numbness, tingling and weakness. Functional limitations are documented in activities of daily living. Clinical examination findings have evidenced positive Spurlings test, motor and sensory deficits, and reflex changes consistent with imaging evidence of central canal stenosis at C5-6 (6.1 mm) and C6-7 (7.3 mm), with reported cord compression at C5-6 and C6 nerve root compromise. There was radiographic evidence of disc space narrowing at C5-6 and C6-7 with anterior spurring at C5-6 and C6-7.
. She currently presents with progressive neurologic complaints, including right hand numbness, positive Hoffmans examination, upgoing toes, broad-based gait, and hyperreflexia of the bilateral lower extremities,
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Overturned
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Medical Necessity
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SummaryA 54-year-old female enrollee has requested authorization and coverage for spine surgeries. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. This patient presents with severe neck pain radiating into the right upper extremity with numbness, tingling and weakness. Functional limitations are documented in activities of daily living. Clinical examination findings have evidenced positive Spurlings test, motor and sensory deficits, and reflex changes consistent with imaging evidence of central canal stenosis at C5-6 (6.1 mm) and C6-7 (7.3 mm), with reported cord compression at C5-6 and C6 nerve root compromise. There was radiographic evidence of disc space narrowing at C5-6 and C6-7 with anterior spurring at C5-6 and C6-7. Evidence of a recent nonoperative treatment protocol trial and failure has been submitted. She currently presents with progressive neurologic complaints, including right hand numbness, positive Hoffmans examination, upgoing toes, broad-based gait, and hyperreflexia of the bilateral lower extremities, right greater than left. Under consideration is a request for anterior cervical discectomy and fusion at C5-6 and C6-7. Based on clinical and imaging findings, there is likely contribution to the symptomatic condition from both levels requested. There is sufficient support for the requested services in this clinical setting. Therefore, the requested spine surgeries are medically necessary for the treatment of this patient.
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A 56-year-old male enrollee has requested reimbursement for genetic testing performed on 2/28/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 56-year-old male enrollee has requested reimbursement for genetic testing performed on 2/28/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that as a standard of care, metastatic colon cancers should be tested for KRAS, NRAS, BRAF, HER2, and microsatellite instability or mismatch repair (MMR) testing. Per the National Comprehensive Cancer Network (NCCN) guidelines, these can be done individually or as part of next-generation sequencing. Next-generation sequencing panels have the ability to pick up rare and actionable mutations and fusions. Universal genetic testing is recommended on all colon cancer tumors, and next-generation sequencing allows for initial screening with microsatellite instability testing. Next-generation sequencing offers the advantage of identifying markers known to have targeted therapy as well as potential clinical trials. FoundationOne is one available test that offers this. The medical evidence supports the services at issue in this clinical setting. Therefore, genetic testing performed on 2/28/18 was medically necessary for the evaluation of this patient.
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The patient is a 43-year-old female with a history of major depressive disorder, chronic pain and insomnia. The patient has failed multiple medications for the treatment of her depression. The patient has also failed transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). The patient had a suicide attempt in 2016 after an overdose on her narcotics. This caused a hypoxic brain injury. The patient has requested authorization and coverage for CPT 64568 (implantation of vagus nerve neurostimulator electrode). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient. This patient has had an extensive treatment history for her depression, including medications, TMS and ECT. However, there was no mention of her psychotherapy history to address her childhood trauma.
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Upheld
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Experimental
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Summary Reviewer 1
The patient is a 43-year-old female with a history of major depressive disorder, chronic pain and insomnia. The patient has failed multiple medications for the treatment of her depression. The patient has also failed transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). The patient had a suicide attempt in 2016 after an overdose on her narcotics. This caused a hypoxic brain injury. The patient has requested authorization and coverage for CPT 64568 (implantation of vagus nerve neurostimulator electrode). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient. This patient has had an extensive treatment history for her depression, including medications, TMS and ECT. However, there was no mention of her psychotherapy history to address her childhood trauma. There was no mention of psychotherapy to help manage her chronic pain. The medical literature has mixed results about the efficacy of the effectiveness of vagus nerve stimulation for treatment-resistant depression. Evidenced-based therapy such as cognitive processing therapy, prolonged exposure therapy, and intensive psychodynamic therapy along with pain management therapy could be utilized to help with the treatment of this patient. Therefore, the requested CPT 64568 (implantation of vagus nerve neurostimulator electrode) is not likely to be of greater benefit than 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.
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A 33-year-old male enrollee has requested authorization and coverage for CPT code 27299 (unlisted procedure, pelvis/hip joint). The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees hip pain.
This patient has extensive labral tearing and degeneration including posterior which
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Overturned
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Medical Necessity
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Summary Reviewer
A 33-year-old male enrollee has requested authorization and coverage for CPT code 27299 (unlisted procedure, pelvis/hip joint). The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees hip pain. The physician reviewer found that surgical hip dislocation is an established technique for addressing both articular and periarticular pathology associated with painful femoral acetabular impingement. This patient has extensive labral tearing and degeneration including posterior which would be difficult or impossible to treat arthroscopically. Periacetabular osteotomy and labral repair cannot be performed open without dislocating the hip. Thus, dislocation of the femoral head is necessary to access and treat the acetabular sided pathology. Given these findings, the requested CPT code 27299 (unlisted procedure, pelvis/hip joint) is supported as medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested procedure is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 55-year-old female enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees severe persistent asthma.
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Upheld
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Medical Necessity
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Summary Reviewer
A 55-year-old female enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees severe persistent asthma. The physician reviewer found that currently, the three initial trials of bronchial thermoplasty have demonstrated improved symptom control in well selected patients after the procedure was completed. Cox and colleagues reported on 112 patients with moderate to severe asthma and demonstrated improved control over the course of the one-year follow-up. Similarly, Pavord and colleagues found short-term worsening in symptoms, but evidence of improved long-term control of asthma. Castro and colleagues compared thermoplasty with a sham procedure and followed the patients for 12 months. The authors found that the thermoplasty group had fewer exacerbations and improved quality of life when compared to the sham group. However, this patients records do not indicate that she is likely to benefit from bronchial thermoplasty. The providers notes allude to a diagnosis of severe persistent asthma and normal pulmonary function testing (PFT). While PFT results may be unremarkable in patients with asthma, once the disease is persistent, the PFT results are often abnormal. Further, this patient is on medications for several illnesses which may mimic asthma, specifically reflux and sinus disease. Lastly, given the normal PFT findings, lack of clear asthma triggers along with persistent symptoms and chronic steroids, vocal cord dysfunction has not been ruled out, which is often confused for asthma and does not respond to bronchodilators, steroids or bronchial thermoplasty. All told, the requested bronchial thermoplasty is not supported as medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested procedure is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 54-year-old female enrollee has requested reimbursement for the shingles vaccine performed on 2/06/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of rheumatoid arthritis.
In this case, the patient has multiple skin conditions including lichen planus, herpes simplex virus, and atopy, and she has been diagnosed with rheumatoid arthritis.
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Upheld
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Experimental
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Summary Reviewer 2
A 54-year-old female enrollee has requested reimbursement for the shingles vaccine performed on 2/06/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of rheumatoid arthritis. The physician reviewer found the varicella-zoster virus causes two clinically distinct forms of infection. Herpes zoster is related to reactivation of varicella-zoster virus infection and is characterized by a painful, unilateral vesicular eruption in a dermatomal distribution. The herpes zoster vaccination can decrease the risk of developing herpes zoster and post-herpetic neuralgia associated with infection. The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of all patients 60 years of age or older, including patients who report a previous episode of zoster and patients with chronic medical conditions (such as chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease), unless those conditions are contraindications. In clinical practice, the vaccine is recommended for patients between 50 and 59 who are receiving low-level immunosuppressive therapy or are expected to receive high-level immunosuppressive therapy or for patients that would have difficulty tolerating a zoster infection. In this case, the patient has multiple skin conditions including lichen planus, herpes simplex virus, and atopy, and she has been diagnosed with rheumatoid arthritis. Rheumatoid arthritis is treated with immunosuppressive medications that would leave the patient vulnerable to infections. Given this patients rheumatoid arthritis and skin conditions, it was appropriate to vaccinate this patient. Therefore, the shingles vaccine performed on 2/06/17 was likely to have been of greater benefit than other treatment options. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is a 63-year-old male with a history of high-risk prostate cancer. A hydrogel spacer
was recommended as well. The Health Insurer has denied the requested services as not medically
necessary for treatment of the insureds medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 63-year-old male with a history of high-risk prostate cancer. A hydrogel spacer
was recommended as well. The Health Insurer has denied the requested services as not medically
necessary for treatment of the insureds medical condition. The physician reviewer found that,
overall, the utilization of proton beam therapy is not recommended for routine use in the
treatment of patients with prostate cancer. Proton beam therapy has unique properties
compared to standard photon beam therapy in its ability to deposit radiation dose and can
potentially result in fewer areas of low scattered radiation dose. Proton beam therapy is currently
utilized and most strongly indicated in settings where severe toxicities would result if normal
tissue constraints cannot be met by photon beam. However, in the treatment of patients with
prostate cancer, studies have failed to show that the use of proton beam therapy results in a
demonstrable, clinically significant difference in overall survival, quality of life, or reduction of
high-grade toxicities over photon beam therapy (Royce and Efstathiou). Proton beam therapy
may be efficacious in the treatment of patients with prostate cancer in cases of unusual anatomy
or in cases of re-irradiation of adjacent tissues. Volumetric modulated arc therapy (VMAT) is a
standard photon therapy radiation technique that is frequently utilized to achieve clinically
equivalent normal organ dose constraints as proton beam therapy (Schroeck, et al.; Nogueira, et
al.). Excellent dose toxicity outcomes have been demonstrated for standard VMAT in locally
advanced prostate cancer. In this case, the records provided for review indicate that this patient
has high-risk prostate cancer, but there is a lack of documentation indicating that the patient had
unusual anatomy or re-irradiation of adjacent tissues. Therefore, the requested proton beam
therapy is not medically necessary for treatment of this patient.
| 1 |
A 62-year-old female enrollee has requested reimbursement for ChemoFX assay performed on 5/08/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 62-year-old female enrollee has requested reimbursement for ChemoFX assay performed on 5/08/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found Chemosensitivity testing, such as ChemoFx, is not considered a standard of care and is not recommended by current guidelines. In vitro assays of chemosensitivity or resistance, such as the ChemoFx assay, have been developed as a method to select the optimal chemotherapy regimen or identify those agents least likely to be effective. However, the utility of these assays have not been prospectively validated. Therefore, ChemoFx assay performed on 5/08/15 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 38-year-old female enrollee has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation from 1/06/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions.
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Upheld
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Medical Necessity
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Summary Reviewer
A 38-year-old female enrollee has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation from 1/06/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the American Psychiatric Association has endorsed transcranial magnetic stimulation for the acute phase treatment of major depressive disorder. Although some preliminary positivism regarding the application of transcranial magnetic stimulation therapy for the bipolar population can be found in the medical literature or in reports from clinical practices in the community, there is an absence of well-controlled and adequately powered exploratory and confirmatory studies regarding this intervention for the treatment of bipolarity at this time. Further, it does not appear that the patient has failed other treatments commonly relied upon to treat bipolar disorder. Additionally, it does not appear that the patient had an informational consultative appointment with an electroconvulsive therapy specialist to learn more about the treatment, as the intervention remains a trusted, rapid and effective treatment for both mania and bipolar depression. Finally, there was a dearth of information regarding the status of supportive relationships and community functioning, or outcomes of non-pharmacological interventions. Although the patient reportedly had tried multiple courses of past psychotherapies, there was no reported outcome of cognitive behavioral therapy and it does not appear that she had trialed other evidence-based therapies for bipolar illness, such as family therapy or interpersonal/social rhythm therapy. All told, transcranial magnetic stimulation from 1/06/16 forward was not and is not medically indicated for the treatment of this patient. Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 39-year-old male enrollee has requested reimbursement for lumbar spine surgery performed in Germany. The Health Insurer has denied this request indicating that the services at issue were not emergent or urgent and were not medically necessary for treatment of the enrollees advanced degenerative disc disease.
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Upheld
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Medical Necessity
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Summary Reviewer
A 39-year-old male enrollee has requested reimbursement for lumbar spine surgery performed in Germany. The Health Insurer has denied this request indicating that the services at issue were not emergent or urgent and were not medically necessary for treatment of the enrollees advanced degenerative disc disease. The physician reviewer found that per the submitted documentation, the surgical intervention performed in Germany was not emergent or urgent. A program of conservative care allowing for return to the United States and resumption of follow-up with treating surgeons in the United States was possible, and there is no documentation of accepted indications for emergent surgery such as acute cauda equina syndrome with abrupt bowel and bladder change. Additionally, the current medical evidence fails to support the medical necessity of the services at issue. In the context of the need for treatment of postoperative infection or mechanical failure of the total disc arthroplasty device, there is a unique and high risk of vascular injury or injury to the ureters in management of these complications. The studies do not adequately reflect likely long-term complications of implantation of metal and metal methyl methacrylate devices in the spine. After implantation of metal and metal methyl methacrylate devices in the knee and hip, it has been demonstrated that the patients are exposed to particulate debris. This particulate debris consisting of abrasive wear and adhesive contact wear between the components of the device elicit a chronic inflammatory reaction including a giant cell tissue response. The effect of this exposure may vary from patient to patient, but all patients will be exposed to the consequences of wear. In total joint arthroplasty at the hip and the knee, problems of subsidence and loosening are known to be associated in some patients with this phenomenon. It is unlikely that the long-term effects of total disc arthroplasty will be any different than metal to plastic arthroplasty in other locations in the body. Van Den Eerenbeemt and colleagues performed a systematic review of the literature of total disc replacement. The authors reviewed three randomized controlled trials and 16 prospective cohort studies comparing total disc replacement with lumbar fusion. The authors concluded that high-quality randomized controlled trials with relevant control groups and long-term follow-up is needed to evaluate the effectiveness and safety of total disc replacement. In summary, the patients experience of pain while in Germany did not provide an indication for emergent or urgent surgery, and a delay with pain management techniques would have allowed additional patient education and the possibility of a positive symptomatic response to conservative care. The lumbar spine surgery performed in Germany was not medically indicated for the treatment of this patient. Therefore, the services at issue were not emergent or urgent and were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The parent of a five-year-old female enrollee has requested authorization and coverage for Tobii Dynavox T10 device and accessories. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollee, who has been diagnosed with cerebral palsy and receptive expressive language disorder.
the parent of a five-year-old female enrollee has requested authorization and coverage for Tobii Dynavox T10 device and accessories. The Health Insurer has denied this request indicating that the
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a five-year-old female enrollee has requested authorization and coverage for Tobii Dynavox T10 device and accessories. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollee, who has been diagnosed with cerebral palsy and receptive expressive language disorder. The physician reviewer found that the parent of a five-year-old female enrollee has requested authorization and coverage for Tobii Dynavox T10 device and accessories. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollee, who has been diagnosed with cerebral palsy and receptive expressive language disorder.
| 1 |
The patient is a 22-year-old male who presented at age 19 with chest pain. The patient has requested reimbursement for the PET scan performed on 4/21/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 22-year-old male who presented at age 19 with chest pain. The patient has requested reimbursement for the PET scan performed on 4/21/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that sarcomas of the heart are exceedingly rare tumors. Most cardiac tumors are benign, and of those that are malignant, the most common are angiomyosarcomas and rhabdomyosarcomas. Of the very rare cardiac sarcomas, synovial sarcomas account for only a tiny percentage. Hence, there is a lack of literature that has evaluated the efficacy of follow-up PET/CT scanning. In this patientas case, considering the high-grade nature of the tumor, as well as the size and presence of necrosis when the tumor was first discovered, there is a high likelihood of recurrence. Information was not submitted concerning whether the initial tumor resection had clean margins. The patient has continued on chemotherapy in spite of no evidence of metastasis or residual tumor. It is unclear what markers are being followed, other than a prophylactic suspicion of recurrence. Sarcomas most commonly recur locally, although they can metastasize (most commonly) to the lungs. One prognostic sign of a likely spread of tumor is tumor necrosis, as was noted in this patient. In order to effectively screen this high risk (and young) patient with CT scanning, one would have to do multiple scans to cover the entire body. Considering the lack of pertinent research and considering the highly aggressive tumor and the fact that the patient continues on chemotherapy, it is medically appropriate to continue the current regimen with regular MRI studies and PET/CT scans. This is especially valuable considering that the patient has a good set of baseline studies. There is sufficient support for the services at issue in this clinical setting. Therefore, the PET scan performed on 4/21/20 was medically necessary for the evaluation of this patient.
| 1 |
A 61-year-old male enrollee has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees prostate cancer.
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Upheld
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Medical Necessity
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Summary Reviewer
A 61-year-old male enrollee has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees prostate cancer. The physician reviewer found that currently, there is insufficient clinical data to discern whether treatment with proton beam radiation offers a clinical benefit compared to conventional radiation therapy techniques in the treatment of prostate cancer. Sheets and colleagues evaluated the comparative effectiveness of intensity modulated radiation therapy (IMRT), proton beam therapy, and conformal radiation therapy for prostate cancer. In the comparison between IMRT and proton therapy, IMRT patients had a lower rate of gastrointestinal morbidity. There were no other significant differences regarding toxicities between IMRT and proton therapy. Yu and colleagues performed an analysis of early toxicity and compared 421 patients treated for prostate cancer with proton therapy and 842 matched case controls treated with IMRT. There was a statistically significant decrease in genitourinary toxicity at six months with proton therapy; however, this difference disappeared by one year. There were no other significant differences in toxicity between the two techniques. A position statement released by American Society of Radiation Oncology (ASTRO) in 2013 stated, At the present time, ASTRO believes the comparative efficacy evidence of proton beam therapy with other prostate cancer treatments is still being developed, and thus the role of proton beam therapy for localized prostate cancer within the current availability of treatment options remains unclear. Therefore, proton beam therapy is not medically necessary for the treatment of this patient.
| 1 |
A 57-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus.
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Overturned
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Medical Necessity
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Summary Reviewer
A 57-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) 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. Evidence clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions. In addition, guidelines state that a High Priority for Treatment Owing to High Risk for Complications include patients with fibrosis of Metavir F2. In this case, the patient has a Metavir score of F2; hence, treatment is indicated. Therefore, Harvoni is medically necessary based on national guidelines. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 48-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 10/15/20. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
At the time that this patient had Guardant360 testing, computed tomography (CT) scan was read as showing
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Upheld
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Experimental
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Summary Reviewer 2
A 48-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 10/15/20. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that liquid biopsies are tests conducted on blood samples that examine biomarkers shed by tumors, such as cancer cells or pieces of tumor DNA. It is used at the time of diagnosis or with tumor recurrence, as cells shed from tumor can be detected in lieu of additional biopsy. At the time that this patient had Guardant360 testing, computed tomography (CT) scan was read as showing no evidence of metastatic disease. Continued surveillance with liquid biopsy performed at the time of documented recurrence would be more likely to yield accurate results. Therefore, Guardant360 testing performed on 10/15/20 was not likely to have been more beneficial than other available standard therapy.
| 1 |
A 21-year-old male enrollee has requested reimbursement for a PET scan performed on 7/23/19. 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 2
A 21-year-old male enrollee has requested reimbursement for a PET scan performed on 7/23/19. 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 the current guidelines generally recommend surveillance scans using computed tomography (CT) or magnetic resonance imaging (MRI) every three to six months based on risk of recurrence, and more frequently within the first two years when risk of recurrence is highest (around 80%). As asymptomatic lung metastases can be resected for curative intent, surveillance imaging is recommended. Synovial tumors, such as in this patient, can recur as late as 10 years. Positron emission tomography (PET) scans have been useful in prognosis if done after neoadjuvant chemotherapy, but there is a lack of support for the use of PET scans for surveillance. PET scan for surveillance is unlikely to be more beneficial than standard imaging in patients with soft tissue sarcoma. In sum, PET scan performed on 7/23/19 was not likely to have been more beneficial than other methods of evaluating this patient.
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The patient is a 36-year-old female who presented to her provider on 9/15/22. The patient has
requested authorization and coverage for Acthar 80 unit/milliliter (mL) injection gel. The Health
Plan has denied this request and reported that the requested medication is not medically
necessary for the treatment of this patient.
a study of eight patients
with refractory rheumatoid arthritis who were given repository corticotropin injections, Gillis and
colleagues
including nine patients with refractory rheumatoid arthritis who had previously been on at least
three biologic disease-modifying antirheumatic
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 36-year-old female who presented to her provider on 9/15/22. The patient has
requested authorization and coverage for Acthar 80 unit/milliliter (mL) injection gel. The Health
Plan has denied this request and reported that the requested medication is not medically
necessary for the treatment of this patient. The physician reviewer found that the submitted
documentation does not support the medical necessity of the requested medication. There are
only limited studies on the use of Acthar gel for rheumatoid arthritis. In a study of eight patients
with refractory rheumatoid arthritis who were given repository corticotropin injections, Gillis and
colleagues noted improvement of tender and joint swelling counts, in disease activity scores for
rheumatoid arthritis (DAS28), and in patient global visual analog scale (VAS) scores. In a study
including nine patients with refractory rheumatoid arthritis who had previously been on at least
three biologic disease-modifying antirheumatic drugs (DMARDs) and did not respond to previous
treatment, Fischer and colleagues found an improvement of DAS28 scores and in quality of life
measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). However, both
of these studies were limited by small sample sizes, were not placebo-controlled, and were not
double blinded. The studies both looked at patients who had failed multiple biologics and had
active rheumatoid arthritis with joint swelling. In this case, the records do not document that the
patient has been on more than one biologic, or that the patient has tried and failed therapies for
rheumatoid arthritis including DMARDs such as methotrexate, sulfasalazine, or leflunomide,
tumor necrosis factor (TNF) inhibitors, abatacept, rituximab, tocilizumab, sarilumab, tofacitinib,
and baricitinib. The clinical records submitted for review did not document joint swelling or
uveitis. Given the lack of data in current medical evidence regarding Acthar as a treatment option
for rheumatoid arthritis, the requested medication is not medically indicated. Therefore, Acthar
80 unit/mL injection gel is not medically necessary for the treatment of this patient.
| 1 |
patient is a 36-year-old female who has a history of a right breast cancer. The patient has requested authorization and coverage for Verzenio 150 mg tablets. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the patient.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 36-year-old female who has a history of a right breast cancer. The patient has requested authorization and coverage for Verzenio 150 mg tablets. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the patient. This denial is the subject of this appeal and determination. The physician reviewer found that there is a lack of support for the requested medication in this clinical setting. In the trial by Johnston and colleagues, over 5,600 patients (just under one-half of whom were premenopausal women) with hormone receptor-positive, HER2-negative, high-risk early breast cancer who had completed surgery were randomly assigned to abemaciclib (Verbenio) with endocrine therapy or endocrine therapy alone. Although the studies preliminary results showed statistically significant improvement in invasive disease-free survival relative to the endocrine therapy alone group, there are no data yet available for overall survival. To date, the addition of abemaciclib to endocrine therapy in high-risk premenopausal women is not considered a standard of care. Therefore, Verzenio 150 mg tablets are not medically necessary for the treatment of this patient.
| 1 |
A 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis.T
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Upheld
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Experimental
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Summary Reviewer 2
A 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis.The physician reviewer found there is a lack of support for the services at issue in this clinical setting. Some evidence exists that low serum levels of adalimumab and/or the presence of antibodies to adalimumab may play a role in primary or secondary response failures. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of adalimumab or the presence of adalimumab antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, while there have been testimonials, there are few well-controlled clinical trials to confirm that use of the Anser ADA testing leads to improved patient outcomes or quality of life as compared to the standard method of treatment. The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement. It has not yet been established whether the use of threshold levels aids in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. Therefore, Anser ADA testing performed on 4/25/16 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 59-year-old male has requested authorization and coverage for CPT 43210 (transoral incisionless fundoplication procedure utilizing the EsoPhyx device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease.
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Upheld
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Experimental
|
Summary Reviewer 1
A 59-year-old male has requested authorization and coverage for CPT 43210 (transoral incisionless fundoplication procedure utilizing the EsoPhyx device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease. The physician reviewer found that there is a lack of support for the requested services in this clinical setting. This patient has pathologic acid reflux. With regards to the requested procedure, there is a lack of long-term studies with a substantial number of patients beyond one year. In addition, many patients who undergo transoral incisionless fundoplication are subsequently on proton pump inhibitor therapy for rescue therapy six months later. There is a paucity of long-term studies comparing transoral incisionless fundoplication to surgical fundoplication. Therefore, CPT 43210 (transoral incisionless fundoplication procedure utilizing the EsoPhyx device) is not likely to be more effective than 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 |
The parent of a 16-year-old transgender male enrollee has requested reimbursement for mental health residential treatment services provided from 9/15/14 through 10/10/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees depression, anxiety and gender dysphoria.
this patient has required various inpatient and residential treatment placements but continued to deteriorate once he was transitioned to a lower level of care. It appears that he had experienced such deterioration prior to the RTC admission at issue. The patient was dealing with complicated issues that included disclosing to his family that he was transgendered and then developing coping strategies to address his gender dysphoria.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 16-year-old transgender male enrollee has requested reimbursement for mental health residential treatment services provided from 9/15/14 through 10/10/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees depression, anxiety and gender dysphoria. The physician reviewer found that this patient has required various inpatient and residential treatment placements but continued to deteriorate once he was transitioned to a lower level of care. It appears that he had experienced such deterioration prior to the RTC admission at issue. The patient was dealing with complicated issues that included disclosing to his family that he was transgendered and then developing coping strategies to address his gender dysphoria. To appropriately address this patients issues and prevent relapse, continued treatment through discharge on 10/10/14 was indicated. Overall, the summary of treatment provided by the attending physician and therapist indicate that the patient was receiving appropriate medical and psychiatric treatment, and that he was benefiting from this treatment and improving. For these reasons, the mental health RTC services provided from 9/15/14 through 10/10/14 were medically necessary for treatment of this patients medical condition. In summary, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 42-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 8/29/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees melanoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 42-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 8/29/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either class 1 or 2, with class 2 melanomas having a significantly higher rate of recurrence than class 1. Gerami reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification, in patients undergoing sentinel node biopsy. Berger and colleagues reported on 156 cases, but there was insufficient follow-up to determine the real value of the assay. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear if the DecisionDx-Melanoma testing assay results can be used to make clinical decision, above and beyond the pathologic details. Therefore, DecisionDx-Melanoma testing performed on 8/29/18 was not likely to have been more effective than other methods of evaluating this patient.
| 0 |
A 62-year-old male enrollee has requested reimbursement for the Life Vest provided from 6/10/15 through 7/10/15. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees dilated cardiomyopathy.
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Upheld
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Experimental
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Summary Reviewer 3
A 62-year-old male enrollee has requested reimbursement for the Life Vest provided from 6/10/15 through 7/10/15. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees dilated cardiomyopathy. The physician reviewer found that review of the current peer-reviewed medical literature does not support wearable cardioverter defibrillators as being proven to demonstrate survival benefit above and beyond medical therapy. Adler and colleagues noted that when the prescription of a wearable defibrillator is being considered, it should be kept in mind that there are no randomized controlled studies showing that provides survival benefit. Further, wearable cardioverter defibrillators are currently indicated for patients who are candidates for an implantable cardioverter defibrillator and are awaiting cardiac transplantation, patients who are candidates for an implantable cardioverter defibrillator and have a temporary contraindication to implantable cardioverter defibrillator implant, and patients who have had an implantable cardioverter defibrillator explanted due to infection and are awaiting re-implantation. As this patient does not meet these criteria, the Life Vest provided from 6/10/15 through 7/10/15 was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the device at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 48-year-old female has requested reimbursement for genotyping for CYP2D6 polymorphism performed on 7/10/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 48-year-old female has requested reimbursement for genotyping for CYP2D6 polymorphism performed on 7/10/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found since tamoxifen must be metabolized to a metabolite to be active, there has been an interest in evaluating the impact of the enzymes that affect this metabolism to an active state. CYP2D6 is involved in the conversion of tamoxifen to endoxifen, its most active metabolite. There have been multiple studies attempting to correlate CYP2D6 genotype to the efficacy of tamoxifen. The overall conclusion is that there is no clear-cut benefit to the use of this genotyping in determining whether tamoxifen should be given to an individual patient. There is insufficient data in either premenopausal or postmenopausal women to establish that CYP2D6 genotyping would be beneficial. Therefore, genotyping for CYP2D6 polymorphism performed on 7/10/14 was not likely to have been of greater benefit than other methods of evaluation. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 46-year-old female enrollee has requested reimbursement for Afirma Gene Expression Classifier testing performed on 9/6/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees thyroid nodule.
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Overturned
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Experimental
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Summary Reviewer 2
A 46-year-old female enrollee has requested reimbursement for Afirma Gene Expression Classifier testing performed on 9/6/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees thyroid nodule. The physician reviewer found that according to Alexander and colleagues Patients with cytologically indeterminate nodules are often referred for diagnostic surgery, though most of these nodules prove to be benign. Gene expression classifiers better distinguish benign from malignant thyroid nodules. In this case, the patients initial cytology was indeterminate for surgery and the Afirma genetic test is a useful tool when cytology is indeterminate. Accordingly, the specimen sent for Afirma gene expression classifier performed on 9/6/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The parent of a 16-year-old transgender male enrollee has requested reimbursement for bilateral mastectomy performed on 6/20/18. The Health Insurer has denied this request indicating that the procedure at issue was not medically necessary for treatment of the enrollees gender dysphoria.
This patient had a mental health assessment from a qualified mental health provider. He
Per the records, this patient had met these suggestions for hormone treatment and social transition.
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Overturned
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Medical Necessity
|
Summary Reviewer
The parent of a 16-year-old transgender male enrollee has requested reimbursement for bilateral mastectomy performed on 6/20/18. The Health Insurer has denied this request indicating that the procedure at issue was not medically necessary for treatment of the enrollees gender dysphoria. The physician reviewer found that the submitted documentation supports the medical necessity of the procedure at issue. This patient had a mental health assessment from a qualified mental health provider. He meets World Professional Association for Transgender Health (WPATH) criteria for chest surgery as a medically necessary treatment for gender dysphoria. The patients age being under 18 does not affect the medical necessity of the procedure. WPATH states that chest surgery for transgender male adolescents may be done under 18. One year of hormone treatment and social transition is suggested, but not required. Per the records, this patient had met these suggestions for hormone treatment and social transition. The current medical evidence supports the procedure at issue in this clinical setting. Thus, bilateral mastectomy performed on 6/20/18 was medically necessary for the treatment of this patient. Therefore, the procedure at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The parent of a 15-year-old female enrollee has requested reimbursement for Prometheus Anser ADA testing performed on 10/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.
During the several months prior to the testing, the patient experienced nausea, low energy and feeling of being unwell with normal gastrointestinal symptoms.
In this case, the patient was having symptoms which were suggestive of relapse.
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a 15-year-old female enrollee has requested reimbursement for Prometheus Anser ADA testing performed on 10/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. During the several months prior to the testing, the patient experienced nausea, low energy and feeling of being unwell with normal gastrointestinal symptoms. Scientific studies have suggested that drug levels and antibody testing for adalimumab is now a standard method to determine disease response to treatment. The studies also suggest that higher levels of adalimumab are associated with better therapeutic outcomes and biologic remission. In this case, the patient was having symptoms which were suggestive of relapse. Thus, it was appropriate for adalimumab levels and antibodies to be measured to determine the next steps in the management of the patients symptoms. 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 53-year-old female has requested reimbursement for advanced lipoprotein testing. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 53-year-old female has requested reimbursement for advanced lipoprotein testing. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the medical records fail to establish the superior efficacy of the services at issue. There is a lack of accepted studies which demonstrate that strategies to correct the residual risk potentially identified by novel lipoprotein will further reduce cardiovascular risk. It is not clear that advanced lipoprotein testing adds significant information to what is already known from a fasting lipid panel. There is insufficient evidence to support the use of advanced lipoprotein analysis in clinical practice. In sum, advanced lipoprotein testing performed on 3/15/16 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
The patient is a 20-year-old female who has been diagnosed with a maxillofacial skeletal deformity. The patient has requested authorization and coverage for reconstruction midface, LeFort 1; three or more pieces, segment movement in any direction, without bone graft (21143) and reconstruction of mandibular rami, horizontal, vertical, C or L osteotomy, with bone graft (includes obtaining graft) (21194). The Health Insurer has denied this request and reported that the requested services are 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 20-year-old female who has been diagnosed with a maxillofacial skeletal deformity. The patient has requested authorization and coverage for reconstruction midface, LeFort 1; three or more pieces, segment movement in any direction, without bone graft (21143) and reconstruction of mandibular rami, horizontal, vertical, C or L osteotomy, with bone graft (includes obtaining graft) (21194). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. The patient has a maxillofacial skeletal deformity that cannot be corrected with orthodontics alone. The requested surgery will result in improved musculoskeletal and dento-osseous relationships and improvement in mastication and associated temporomandibular joint and associated muscular disorders. The requested procedure is medically appropriate for the treatment of this patientas condition and is within generally accepted standards of medical care. Therefore, reconstruction midface, LeFort 1; three or more pieces, segment movement in any direction, without bone graft (21143) and reconstruction of mandibular rami, horizontal, vertical, C or L osteotomy, with bone graft (includes obtaining graft) (21194) are medically necessary for the treatment of this patient.
| 1 |
A 23-year-old female enrollee has requested reimbursement for continued stay at partial hospital substance use disorders treatment provided from 9/27/17 through 10/01/17. 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 progress notes indicated that the patient was cooperative in treatment. The progress notes for the disputed timeframe indicate that the patient was attentive during group discussions and was engaged in therapy discussions. Per the records, this patient could have received effective treatment on an intensive outpatient basis or outpatient basis. She was motivated for treatment with mention of insight into her illness as well as documentation of her knowledge of skills to maintain sobriety. The supplied documentation does not indicate that she was having severe mood swings or other severe psychiatric symptoms.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 23-year-old female enrollee has requested reimbursement for continued stay at partial hospital substance use disorders treatment provided from 9/27/17 through 10/01/17. 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 the submitted documentation fails to demonstrate the medical necessity of the services at issue. The progress notes indicated that the patient was cooperative in treatment. The progress notes for the disputed timeframe indicate that the patient was attentive during group discussions and was engaged in therapy discussions. Per the records, this patient could have received effective treatment on an intensive outpatient basis or outpatient basis. She was motivated for treatment with mention of insight into her illness as well as documentation of her knowledge of skills to maintain sobriety. The supplied documentation does not indicate that she was having severe mood swings or other severe psychiatric symptoms. In cases such as this, an evidence-based, objective, instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) is indispensable in determining necessary and appropriate level of care for adults. With regards to risk of harm, the records support a score of 1 due to a lack of current suicidal ideation and no self-harming behaviors. In terms of functional status, the records support a score of 2 or 3 due to the loss of her job prior to treatment and continued substance use. With regards to medical, addictive and psychiatric comorbidity, the records support a score of 2 due to overall medical stability. In terms of level of stress of the recovery environment, the records support a score of 3. There was mention of being homeless on admission due to substance use. With regards to level of support of the recovery environment, the records support a score of 2 due to family support and availability of treatment resources. In terms of treatment and recovery history, the records support a score of 3. The treatment progress notes indicate that she had good progress and participation in her partial hospitalization program treatment. With regards to engagement and recovery status, the records support a score of 2 due to cooperation in treatment and insight into her need for treatment. Thus, the patient has a composite score of 15 or 16. This score correlates with the community-based outpatient clinic setting. In sum, the patient could have been treated in a less restrictive setting. All told, continued stay at partial hospital substance use disorders treatment provided from 9/27/17 through 10/01/17 was not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 28-year-old male enrollee has requested reimbursement for cyanocobalamin (vitamin B-12) testing performed on 7/24/19. 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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Upheld
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Medical Necessity
|
Summary Reviewer
A 28-year-old male enrollee has requested reimbursement for cyanocobalamin (vitamin B-12) testing performed on 7/24/19. 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 Vitamin B12 deficiency is considered as a possible problem for patients who have associated anemia, gastrointestinal issues (which may lead to poor absorption) or neuropsychiatric problems, including irritability or cognitive decline with nerve problems. Typically, the evaluation includes a history and physical examination with abnormal dermatologic, neurologic or gastrointestinal problems. The laboratory evaluation includes B12, folate levels and a complete blood count. In this case, the documentation does not support that the patient had medical conditions or symptoms that would be consistent with vitamin B12 deficiency. Furthermore, there was no laboratory testing to include a folate level or complete blood count. Therefore, cyanocobalamin (vitamin B-12) testing performed on 7/24/19 was not medically necessary for the evaluation of this patient.
| 0 |
A 72-year-old male enrollee has requested reimbursement for Oncotype DX Prostate Cancer Assay performed on 4/21/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for evaluation of the enrollees prostate cancer.
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Upheld
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Medical Necessity
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Summary Reviewer
A 72-year-old male enrollee has requested reimbursement for Oncotype DX Prostate Cancer Assay performed on 4/21/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for evaluation of the enrollees prostate cancer. The physician reviewer found there currently are three major approaches to the management of localized prostate cancer. These include surgical prostatectomy, radiation therapy, and active surveillance. Recommendations are made as to these options based on risk stratification, which estimates the risk for the future development of progressive cancer. The patients cancer is evaluated with a combination of clinical features, prostate-specific antigen, and pathologic details, particularly Gleason cancer grade. By such a method, patients can be placed into four general categories: very low risk, low risk, intermediate risk, and high risk. Therapeutic recommendations will then depend on this risk classification. By this methodology, this patient would be classified as very low risk, for whom surveillance only would be the recommendation. A further refinement of prognostication is the use of gene panels, such as Oncotype DX Prostate Cancer Assay. This is a panel of 17 genes that may assist in predicting recurrence after treatment for prostate cancer. It is being used to some degree in localized cancer as a possible aid in decision making. However, in this setting of a very low risk patient, it has not been clinically validated as ultimately clinically beneficial. In this patients case, the services at issue were not medically indicated given his very low risk cancer. Thus, Oncotype DX Prostate Cancer Assay performed on 4/21/17 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 60-year-old female enrollee has requested reimbursement for gene tests performed on 6/09/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees non-small cell lung cancer.
In this patients case, apparently her liver biopsy was positive for an epidermal growth factor receptor (EGFR) exon 19 mutation.
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Overturned
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Experimental
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Summary Reviewer 1
A 60-year-old female enrollee has requested reimbursement for gene tests performed on 6/09/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees non-small cell lung cancer. The physician reviewer found that for patients with adenocarcinoma, there is clinical value in testing the tissue for certain mutations. In this patients case, apparently her liver biopsy was positive for an epidermal growth factor receptor (EGFR) exon 19 mutation. Therefore, this indicated that Tarceva might be useful. When patients on Tarceva progress, it is valuable to test for a further EGFR mutation (T790M) by a blood test, such as Guardant. If this new mutation is present, there is a treatment directed at that (Tagrisso). However, testing for a wide variety of other mutations is currently not clinically beneficial, as it has not been demonstrated that giving a treatment directed at a target found in that way is an improvement over giving a treatment based on the clinicians judgment. Finding a mutation does not guarantee that a drug directed at that target will be efficacious. All told, testing for T790M alone was likely to have been more efficacious than other methods of evaluating this patient. However, the superior efficacy of the remaining of the services at issue has not been established. Based upon the information set forth above, a portion of the services 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 partially overturned.
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A 59-year-old female enrollee has requested reimbursement for CPT codes 81201-90, 81210-90, 81211-90, 81282-90, 81295-90 and 81298-90 provided on 2/19/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 59-year-old female enrollee has requested reimbursement for CPT codes 81201-90, 81210-90, 81211-90, 81282-90, 81295-90 and 81298-90 provided on 2/19/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that understanding the molecular drivers of cancer progression and metastases is an area of ongoing and active research, predominantly driven by the goal of identifying specific genomic aberrations that may ultimately result in individualized cancer treatment. In addition to likely providing prognostic information, the value of next generation sequencing to predict candidates for specific mutation-driven treatment holds promise but is not yet ready for routine clinical use. Although the ability to decipher genomic aberrations in individual breast cancers to the single nucleotide resolution is now possible, there is a lack of data to show that this information can guide treatment decisions for patients with metastatic breast cancer. The use of next generation sequencing, such as with FoundationOne testing, continues to be the subject of ongoing clinical trials. Therefore, CPT codes 81201 and 81210 provided on 2/19/18 were not medically necessary for the evaluation of this patient.
| 0 |
A 22-year-old male enrollee has requested reimbursement for partial hospitalization from 8/31/15 through 10/22/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
. The patient has a history of suicide attempts. He attempted to hang himself and overdose on medications. He also had homicidal thoughts of going to his school and harm to others. He denied any suicidal ideation or homicidal ideation on 8/31/15. The patients functional status is scored a 3, moderate impairment. The patient has a history of serious impairment through his substance use. He dropped out of college and lost his job. He ended up in jail for 30 days after verbally threatening to stab a man. However, the patient had eight months of sobriety and has made progress. He continued to have symptoms of depression, anxiety, and paranoia and had interpersonal problems with his parents.
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Upheld
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Medical Necessity
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Summary Reviewer
A 22-year-old male enrollee has requested reimbursement for partial hospitalization from 8/31/15 through 10/22/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue in this clinical setting. To objectively determine if the patient meets criteria for length of stay, the Level of Care Utilization System (LOCUS) criteria is utilized. This is an accepted, national standard for determining the appropriate level of care for adults. According to the LOCUS criteria, on 8/31/15, the patients risk of harm was scored a 3 which correlates to a moderate risk of harm. The patient has a history of suicide attempts. He attempted to hang himself and overdose on medications. He also had homicidal thoughts of going to his school and harm to others. He denied any suicidal ideation or homicidal ideation on 8/31/15. The patients functional status is scored a 3, moderate impairment. The patient has a history of serious impairment through his substance use. He dropped out of college and lost his job. He ended up in jail for 30 days after verbally threatening to stab a man. However, the patient had eight months of sobriety and has made progress. He continued to have symptoms of depression, anxiety, and paranoia and had interpersonal problems with his parents. As for his medical, addictive, and psychiatric comorbidity, his score is a 3, which correlates to significant comorbidity. The patient had a comorbidity of bipolar disorder and polysubstance abuse. The patient did not have any serious medical problems. His recovery environment is scored a 2, mildly stressful environment. It appears that the patient had left a sober home environment and was living alone. The patients level of support is scored a 2, which correlates to a supportive environment. The patients parents are supportive of the patient. His treatment history is scored a 2, significant response to treatment. The patient has been attending Alcoholics Anonymous and participating with a sponsor. He had eight months of sobriety. He continued to have some symptoms of depression, anxiety, and paranoia. The patients engagement and recovery status is scored a 2, which correlates to positive engagement and recovery. The patient has a strong desire to remain sober. He participated in groups and treatment. According to the LOCUS criteria, the patients total composite score is 17 and would have met criteria for an intensive outpatient program. The patient continued to require treatment for his bipolar disorder, anxiety, depression, emotional dysregulation, and polysubstance abuse. However, this could have been performed in a less restrictive environment. In sum, partial hospitalization level of care from 8/31/15 through 10/22/15 was not medically necessary for the treatment of this patients medical condition.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 30-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg tablet.
The Health Insurer has denied this request and reported that the requested medication is
investigational for the treatment of the enrollees medical condition.
This patients
provider is requesting another JAK inhibitor, tofacitinib. In addition, per clinical notes from the
patients dermatologist, the patient has tried and failed other treatments, including topical
steroids and oral minoxidil. Notably, the patient has done well on Xeljanz since March 2021, with
near total regrowth of hair.
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Overturned
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Experimental
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Summary Reviewer 2
A 30-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg tablet.
The Health Insurer has denied this request and reported that the requested medication is
investigational for the treatment of the enrollees medical condition. The physician reviewer
found that there is no currently FDA approved treatment for alopecia areata, totalis, and similar
alopecias. Thus, there is no standard approved treatment. Baricitinib (Janus kinase (JAK)
inhibitor) has done well in phase 2 clinical trials and may be soon approved. This patients
provider is requesting another JAK inhibitor, tofacitinib. In addition, per clinical notes from the
patients dermatologist, the patient has tried and failed other treatments, including topical
steroids and oral minoxidil. Notably, the patient has done well on Xeljanz since March 2021, with
near total regrowth of hair. There are several large case series reports in the literature of
improvement of alopecia with tofacitinib. Thus, there is a large body of growing evidence that
JAK inhibitors, in particular tofacitinib, is efficacious for alopecia areata/totalis. Therefore, Xeljanz
5 mg tablet is likely to be more beneficial than any available standard therapy.
| 1 |
A year-old female enrollee has requested reimbursement for collagen crosslink testing provided on 4/17/19. 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 1
A year-old female enrollee has requested reimbursement for collagen crosslink testing provided on 4/17/19. 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 Osteoporosis is a condition of thinning of the bones that leads to an 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 (DEXA). Bone mineral density assessment via DEXA is still the criterion standard for evaluation and diagnosis of osteoporosis. However, because changes in bone mass and density in response to antiresorptive therapy account for only a small portion of the predicted fracture risk reduction, markers of bone turnover may be a useful adjunct in monitoring of osteoporotic patients treated with antiresorptive agents. Medical 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. There is sufficient support for the services at issue in this clinical setting. Therefore, collagen crosslink testing provided on 4/17/19 was likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 53-year-old female enrollee has requested reimbursement for PathFinder TG testing (84999) performed on 7/30/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 53-year-old female enrollee has requested reimbursement for PathFinder TG testing (84999) performed on 7/30/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found current Guidelines from the American Gastroenterological Association Institute do not mention the use of molecular markers for the management of suspicious pancreatic cysts. A recently published technical review by the American Gastroenterological Association of the diagnosis of pancreatic cysts states that routine use cannot be supported at this time. At this time, although molecular testing is encouraging, further validation is needed. All told, PathFinder TG testing (84999) performed on 7/30/14 was not likely to have been of greater benefit than other modalities. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 36-year-old female who was admitted to a residential treatment center (RTC) on
8/21/22. The patient has requested reimbursement for substance abuse inpatient treatment
from 8/26/22 through 9/14/22.
For dimension 1, the patient was assessed for alcohol withdrawal earlier in her
treatment stay and managed with phenobarbital. She reported mild symptoms of PAWS. The
patients withdrawal needs were safely managed in
For dimension 3, the patient had diagnoses of major depressive disorder and anxiety.
She endorsed suicidal ideation on 8/16/22 due to her fiance breaking up with her but denied
suicidal ideation as of 8/21/22.
. She participated in group sessions. The patients mental
status was stable enough to permit participation, but the records did not indicate that she was
unable to control her use of alcohol or was in
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 36-year-old female who was admitted to a residential treatment center (RTC) on
8/21/22. The patient has requested reimbursement for substance abuse inpatient treatment
from 8/26/22 through 9/14/22. The physician reviewer found that per American Society of
Addiction Medicine (ASAM) criteria, this patient did not meet Level 3.5 criteria for RTC services
from 8/26/22 through 9/14/22. ASAM criteria focuses on six dimensions to determine the
appropriate level of care, which includes: (1) intoxication and withdrawal potential; (2)
biomedical conditions; (3) emotional, behavioral and cognitive conditions; (4) readiness to
change; (5) relapse, continued use, or continued problem potential; and (6) recovery
environment. For dimension 1, the patient was assessed for alcohol withdrawal earlier in her
treatment stay and managed with phenobarbital. She reported mild symptoms of PAWS. The
patients withdrawal needs were safely managed in a Level 3.5 setting. This criterion was met.
For dimension 2, the patient did not have significant medical problems. The patients biomedical
problems were stable and did not require 24-hour medical or nurse monitoring. This criterion
was met. For dimension 3, the patient had diagnoses of major depressive disorder and anxiety.
She endorsed suicidal ideation on 8/16/22 due to her fiance breaking up with her but denied
suicidal ideation as of 8/21/22. The records did not note a history of overdose, suicide attempts,
or aggressive behaviors toward others. She participated in group sessions. The patients mental
status was stable enough to permit participation, but the records did not indicate that she was
unable to control her use of alcohol or was in imminent danger of relapse, with attendant
likelihood of harm to self, others, or property, demonstrated antisocial behavior patterns, had
significant functional deficits of a pervasive nature requiring treatment that is primarily
habilitative in focus that were likely to respond to staff interventions, or concomitant personality
disorders of such severity that the accompanying dysfunctional behaviors provided opportunities
to promote continuous boundary setting interventions. This criterion was not met. For dimension
4, the patient admitted herself for treatment voluntarily. She was able to admit that she had an
alcohol use disorder, participated in her treatment, and expressed interest in changing. The
records did not indicate that the patient had limited insight and little awareness of the need for
continuing care, marked difficulty in understanding the relationship between substance use,
mental health, or life problems and her impaired coping skills and level of functioning,
demonstrated passive or active opposition to addressing the severity of her addiction problem,
or required structured therapy and a 24 hour programmatic milieu because motivational
interventions had not succeeded at less intensive levels of care. The patient did not have a
perspective that impaired her ability to make behavior changes without repeated, structured
motivational interventions, express little to no interest in changing, or attribute her alcohol, drug
or mental health problem to other persons or external events. This criterion was not met. For
dimension 5, the patient reported drinking at least eight ounces of liquor daily. She recognized
the need for treatment and continuing care. The patient did not have a history of suicidal or
homicidal ideation, suicide attempts or aggression. She did not endorse cravings. The records did not indicate that the patient lacked insight into benefits of continuing care and was therefore not
committed to treatment, was unable to control use of alcohol or experiencing cravings with the
situation posing an imminent danger of harm to self or others in the absence of close 24-hour
monitoring and structured support, was in imminent danger of relapse with dangerous
emotional, behavioral, or cognitive consequences as a result of a crisis situation, continued to
use alcohol despite recent active participation in treatment at a less intensive level of care, or
demonstrated a lifetime history of repeated incarceration. This criterion was not met. For
dimension 6, the patient lived with her father, who did not drink, and her ex-fiance, who moved
out of the residence during the patients treatment stay. She appeared to be somewhat socially
isolated and to lack sober supports other than her father. The patient's social network was
characterized by significant social isolation or withdrawal such that recovery goals were assessed
as unachievable at a less intensive level of care. This criterion was met. Given these findings, the
patient did not meet the six ASAM criteria for RTC services provided from 8/26/22 through
9/14/22. Accordingly, substance abuse inpatient treatment from 8/26/22 through 9/14/22 was
not medically necessary for treatment of this patient.
| 1 |
A 40-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/08/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.
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Overturned
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Experimental
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Summary Reviewer 2
A 40-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/08/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found there is sufficient support for the service at issue in this patients case. 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 noted integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. In sum, digital breast tomosynthesis performed on 9/08/16 was likely to have been more effective than other modalities for evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 26-year-old female enrollee has requested reimbursement for myPath Melanoma test performed
on 12/30/21. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insureds melanoma. The physician reviewer found
that the records document that this patient has a history of right lateral posterior shoulder
melanoma. The patient underwent the myPath Melanoma test for further evaluation of her lesion.
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Upheld
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Experimental
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Summary Reviewer 2
A 26-year-old female enrollee has requested reimbursement for myPath Melanoma test performed
on 12/30/21. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insureds melanoma. The physician reviewer found
that the records document that this patient has a history of right lateral posterior shoulder
melanoma. The patient underwent the myPath Melanoma test for further evaluation of her lesion.
Per the American Society of Dermatopathology, appropriate use criteria for evaluation of
melanocytic lesions is of uncertain appropriateness for the vast majority of clinical scenarios
(Fung, et al.). On review of the available documentation, this patients lesion did not require
assessment with the myPath Melanoma test. In the clinical setting with findings that could be
interpreted as ambiguous, the standard of care is to consult with another pathologist before
reaching the conclusion that the histomorphologic findings are truly ambiguous and warrant an
ancillary gene expression profiling test that is largely of uncertain clinical benefit. Therefore, the
myPath Melanoma test performed on 12/30/21 was not likely to be more beneficial for evaluation
of the patients medical condition than any available standard therapy.
| 1 |
patient is a 52-year-old female with a past history of long-term eating disorder, laxative abuse, chronic hyponatremia, hypercoagulable state treated with Pradaxa, and deep vein thrombosis who presented to the hospital in hypovolemic shock secondary to upper gastrointestinal bleed. She was hypotensive, with systolic blood pressure in the 60s and tachycardia.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 52-year-old female with a past history of long-term eating disorder, laxative abuse, chronic hyponatremia, hypercoagulable state treated with Pradaxa, and deep vein thrombosis who presented to the hospital in hypovolemic shock secondary to upper gastrointestinal bleed. She was hypotensive, with systolic blood pressure in the 60s and tachycardia. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The patient was able to ambulate to the stretcher. There is no documentation of frequent turning of the patient or hourly fingerstick blood glucose levels. There is no documentation of the necessity for intravenous fluids or the necessity for intravenous medication. Furthermore, there is documentation that the patient has had treatment multiple treatments at this facility in addition to other facilities, but this is a facility that she was agreeable to. There is no documentation of exceptional factors supporting medical necessity for this facility rather than alternative facilities with closer geographic proximity. Therefore, A0426, A0430, A0435, A0434 for date of service 6/22/19 were not medically necessary for the treatment of this patient.
| 1 |
The patient is a 24-year-old male with schizophrenia, anxiety disorder, and severe cannabis use
disorder. The patient has requested reimbursement and prospective authorization and coverage
for adult mental health residential treatment center services from 5/07/22 forward.
The patient was admitted for
residential treatment with command auditory hallucinations telling him to kill himself along with
sense of worthlessness and hopelessness. As patient has slowly improved during residential
treatment stay, he has denied any suicidal ideation in the period in question, although he has
continued to be paranoid and with questionable continued psychotic
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 24-year-old male with schizophrenia, anxiety disorder, and severe cannabis use
disorder. The patient has requested reimbursement and prospective authorization and coverage
for adult mental health residential treatment center services from 5/07/22 forward. The
physician reviewer found that the American Association of Community Psychiatrists Level of Care
Utilization System (LOCUS) provides a reliable framework for determining the appropriate level
of care for adults needing mental health treatment. Using LOCUS, providers score patients on a
scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions include: (1) risk
of harm; (2) functional status; (3) medical, addictive and psychiatric comorbidity; (4) recovery
environment (a. stressors and b. supports); (5) treatment and recovery history; and (6)
engagement. The composite score is then used to determine the level of care needed. Applying
the LOCUS framework, the patient met the criteria for residential treatment center services
provided 5/07/22 forward. For dimension 1, risk of harm, the records support a score of 4. This
dimension assesses the potential for harm to self or others. The patient was admitted for
residential treatment with command auditory hallucinations telling him to kill himself along with
sense of worthlessness and hopelessness. As patient has slowly improved during residential
treatment stay, he has denied any suicidal ideation in the period in question, although he has
continued to be paranoid and with questionable continued psychotic symptoms, which would
continue to put him at harm if they continue to be command in nature. For dimension 2, function,
the records support a score of 4. This dimension assesses the degree to which a patient is able to
fulfill social responsibilities and maintain physical functioning and capacity for self-care. This
patient has great difficulty functioning normally, is significantly withdrawn, and avoids social
interactions. He is unable to work or go to school and has difficulties with his grooming and taking
care of his needs. For dimension 3, comorbidity, the records support a score of 3. This dimension
assesses potential complications in the course of treatment due to acuity or disability related to
co-occurring medical illness, substance use disorder, or psychiatric disorder. The patient has
continued to use cannabis prior to admission to the residential treatment center despite
heightened depression, anxiety, and psychotic symptoms and is not motivated to stop using
cannabis although use has been temporarily arrested through the structured treatment setting.
For dimension 4A, level of stress of the recovery environment, the records support a score of 3.
This dimension assesses the stressors in the environment, social circumstances, and
interpersonal relationships. The patient has been isolated from others, unable to work due to his
symptoms, and is financially dependent on his mother. Additionally, the patient has difficulty
avoiding exposure to substances outside of treatment. For dimension 4B, level of support of the
recovery environment, the records support a score of 3. This dimension assesses the presence
of family and social support to augment the recovery environment. The patient depends heavily
on his mother, although he has withdrawn due to significant anxiety and psychotic symptoms.
For dimension 5, treatment and recovery history, the records support a score of 4. This dimension
assesses how past experiences with treatment and recovery might indicate how the patient
might respond in the future. The patients previous treatment has not achieved complete
remission of symptoms as he continues to have significant anxiety and psychotic symptoms and
inability to pursue school or maintain a job because of these symptoms. He has engaged in
intensive outpatient program (IOP) and several episodes of inpatient level of care without sustained remission of symptoms. For dimension 6, engagement, the records support a score of
4. This dimension assesses a patients understanding of his illness and treatment, and ability and
willingness to engage in the treatment process. The patient has significant anxiety and psychotic
symptoms and avoids contact with and use of treatment resources if left to his own devices.
These findings give the patient a composite score of 25, which is consistent with medically
monitored residence-based services or residential treatment. Additionally, scores of 4 in risk of
harm and level of functioning necessitate treatment at his higher level of care. For these reasons,
the adult mental health residential treatment center services provided from 5/7/22 forward were
and are medically necessary for treatment of this patient.
| 1 |
A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 6/01/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.T
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Overturned
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Experimental
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Summary Reviewer 3
A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 6/01/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.The physician reviewer found Tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. However, in this patients case, there were no problems to be solved. The patient did not have dense breasts, a mass, palpable lumps, or suspicious calcifications. There is a lack of support for the services at issue in this setting. Thus, digital breast tomosynthesis performed on 6/01/15 was not likely to have been of greater benefit than other options for evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 27-year-old female enrollee has requested reimbursement and prospective authorization and coverage for acute inpatient psychiatric rehabilitation services provided from 9/3/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees schizoaffective disorder.
the patient is gravely disabled by her mental illness and has required multiple psychiatric hospitalizations. She had florid psychosis and planned to kill a family member.
. The patient had been described as labile, uncooperative, irritable, agitated, delusional, disorganized and homicidal. Convincing her to take medication was an arduous process. On 8/29/15, she was agitated, illogical and needed intramuscular administration of an antipsychotic medicine to address her psychosis. On 8/30/15, she was fixated on needing a vaporizer to deliver marijuana to temper her homicidality. On 8/31/15, she was refusing medication, hostile, aggressive and threatening.
. The patients energy improved while her sedation waned. The patient consistently denied any suicidality, homicidal ideat
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Overturned
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Medical Necessity
|
Summary Reviewer
A 27-year-old female enrollee has requested reimbursement and prospective authorization and coverage for acute inpatient psychiatric rehabilitation services provided from 9/3/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees schizoaffective disorder. The physician reviewer found the patient is gravely disabled by her mental illness and has required multiple psychiatric hospitalizations. She had florid psychosis and planned to kill a family member. As such, a conservative hospitalization to improve her condition and prevent a more serious episode of illness was to be expected. Discharge prior to 9/28/15 would have been premature and more than likely would have resulted in undue morbidity, unnecessary risk to the community and prompt readmission as the illness burden that prompted the admission had not yet resolved. The patient had been described as labile, uncooperative, irritable, agitated, delusional, disorganized and homicidal. Convincing her to take medication was an arduous process. On 8/29/15, she was agitated, illogical and needed intramuscular administration of an antipsychotic medicine to address her psychosis. On 8/30/15, she was fixated on needing a vaporizer to deliver marijuana to temper her homicidality. On 8/31/15, she was refusing medication, hostile, aggressive and threatening. However, the psychiatric progress notes did reflect the emergence of durable improvement and by 9/28/15 there was no mention of medication changes, tolerability issues or non-adherence. The patients energy improved while her sedation waned. The patient consistently denied any suicidality, homicidal ideation or hallucinations. In addition, there was no report of disruptiveness on the unit. In the absence of any clinical documentation after 9/28/15, the patient had achieved a level of stability that would be conducive for ongoing specialty care in a less restrictive setting. All told, the acute inpatient psychiatric rehabilitation services provided from 9/3/15 through 9/28/15 were medically necessary for treatment of this patients medical condition, while services from 9/29/15 forward were not and are not medically necessary. In conclusion, a portion of the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
| 1 |
A 46-year-old female enrollee has requested authorization and coverage for bone marrow
aspiration (38220). The Health Insurer has denied this request and reported that the requested
services are investigational for the treatment of the enrollees medical condition.
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Upheld
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Experimental
|
Summary Reviewer 2
A 46-year-old female enrollee has requested authorization and coverage for bone marrow
aspiration (38220). The Health Insurer has denied this request and reported that the requested
services are investigational for the treatment of the enrollees medical condition. The physician
reviewer found that Lin and colleagues performed a study comparing bone marrow aspirate
concentrate with cancellous allograft to iliac crest bone graft in the treatment of long bone
nonunions. The authors concluded, We found no significant difference in union rate for long
bone nonunions treated with iliac crest bone graft or bone marrow aspirate concentrate with
allograft. Bone marrow aspirate concentrate and allograft led to 75% successful healing in this
series. Given the heterogeneity of the control group and loss to follow-up, further prospective
investigation should be conducted to more rigorously compare bone marrow aspirate concentrate
to iliac crest bone graft for nonunion treatment. Blanton and colleagues noted, The stem cells
collected are multipotent and regenerative in nature. In addition to stem cells, other biological components collected augment the mitogen of local cells, proliferation, and angiogenesis, and
inhibit proinflammatory cytokine and bacteria to optimize an environment to heal. The most
common site for harvest is the iliac crest. Techniques for harvesting bone marrow aspirate are
simple to perform, financially modest, and associated with low morbidity. Additional research is
needed to evolve and standardize the technology; however, bone marrow aspirate is proven to be
advantageous for tissue repair. Modest and colleagues noted, Femoral neck nonunion in young
patients is a challenging problem with treatment strategies aimed at improving the biological and
biomechanical fracture environment. While the use of both vascularized and nonvascularized
bone grafting has shown promising results, they have high complication rates and substantial
donor site morbidity. Bone marrow aspirate concentrate has demonstrated multiple uses
throughout orthopedic surgery and may result in an improved fracture healing environment with
minimal patient morbidity. Schottel and colleagues noted, Bone marrow aspirate grafting
entails mesenchymal stem cell-containing bone marrow harvesting and injection into a fracture
site to promote bone formation. Although the use of bone marrow aspirate in orthopedic trauma
is not widespread, an increasing number of studies are reporting clinical success. Advantages of
using bone marrow aspirate are that it is readily obtainable, has low harvest morbidity, and can
be easily and quickly injected. However, no universally accepted role for its use exists. Future
studies directly comparing bone marrow aspirate with conventional techniques are needed to
define its role in the treatment of orthopedic trauma patients. This patient was being treated for
a proximal tibial fracture. She presented status post a left knee tibial tubercle osteotomy
performed in April 2021. She had a complication from the procedure, namely a tibial shaft
fracture. She was not immobilized during this time. It is unclear whether the fracture appeared in
the summer of last year or later. The lack of immobilization has resulted
| 0 |
A 59-year-old male enrollee has requested reimbursement for Guardant 360 testing performed
on 3/31/21. The Health Insurer has denied this request and reported that the services at issue
were investigational for the evaluation of the enrollees medical condition.
|
Overturned
|
Experimental
|
Summary Reviewer 3
A 59-year-old male enrollee has requested reimbursement for Guardant 360 testing performed
on 3/31/21. 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 The National Comprehensive Cancer Network guidelines state, The use of
cell-free/circulating tumor DNA testing can be considered in specific clinical circumstances, most
notably: in the initial diagnostic setting, if following pathologic confirmation of a non-small cell
lung cancer diagnosis there is insufficient material for molecular analysis, cell-free or circulating
tumor DNA should be used only if follow-up tissue-based analysis is planned for patients in which
an oncogenic driver is not identified. In this case, the patient did not have sufficient material on
the biopsy to evaluate for driver mutations. The medical evidence supports the services at issue
in this clinical setting. For patients with advanced non-small cell lung cancer, liquid biopsy-based
test is reliable as standard of care tissue testing. Therefore, Guardant 360 testing performed on
3/31/21 was likely to have been more beneficial than any available standard therapy.
| 0 |
A 52-year-old female enrollee has requested authorization and coverage for sclerotherapy. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition.
|
Upheld
|
Experimental
|
Summary Reviewer 3
A 52-year-old female enrollee has requested authorization and coverage for sclerotherapy. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that in this case, the ultrasound report does not indicate the extent of involvement of the great saphenous vein (or the sizes) and also does not indicate if the saphenofemoral or saphenopopliteal junctions are involved. There is also no indication of the size of the veins. The short saphenous vein in particular is described as only having reflux in its cranial extension. Despite the above, sclerotherapy is clinically indicated in this clinical setting given the lack of other treatment options available. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 59-year-old female enrollee has requested reimbursement for arthroscopy, knee, surgical, abrasion arthroplasty (includes chondroplasty when necessary) or multiple drilling of microfractures performed on 8/16/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition.
|
Upheld
|
Experimental
|
Summary Reviewer 2
A 59-year-old female enrollee has requested reimbursement for arthroscopy, knee, surgical, abrasion arthroplasty (includes chondroplasty when necessary) or multiple drilling of microfractures performed on 8/16/19. 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 the role of arthroscopic debridement in the painful degenerative knee is controversial. Studies have shown that arthroscopic surgery for knee osteoarthritis provides no additional benefit to optimized physical and medical therapy. However, there are some exceptions to this rule. Patients with symptomatic meniscal tears and degenerative changes in the knee can benefit from arthroscopic meniscectomy, particularly if they are having mechanical symptoms such as locking. Similarly, a large loose body causing mechanical symptoms should be removed, even in the presence of osteoarthritis. Loose body removal has been proven to be more effective than conservative treatment for knee osteoarthritis. Therefore, the partial medial meniscectomy and loose body removal were medically necessary. The third procedure is abrasion chondroplasty, which has been denied. The role of arthroscopic debridement in the painful degenerative knee is controversial. Abrasion chondroplasty consists of shaving of fibrillated loose articular cartilage with a mechanical shaver. Studies have shown that such arthroscopic debridement for knee osteoarthritis provides no additional benefit to optimized physical and medical therapy. As such, arthroscopy, knee, surgical, abrasion arthroplasty (includes chondroplasty when necessary) or multiple drilling of microfractures performed on 8/16/19 was not likely to have been more beneficial for treatment of the patientas medical condition than any available standard therapy.
| 1 |
A 68-year-old male enrollee has requested reimbursement for the positron emission tomography (PET) scan performed on 2/3/15. The Health Insurer has denied this request indicating that the diagnostic procedure at issue is considered investigational for evaluation of the enrollees cognitive impairments, neuropsychiatric symptoms and parkinsonian features.
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Overturned
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Experimental
|
Summary Reviewer 2
A 68-year-old male enrollee has requested reimbursement for the positron emission tomography (PET) scan performed on 2/3/15. The Health Insurer has denied this request indicating that the diagnostic procedure at issue is considered investigational for evaluation of the enrollees cognitive impairments, neuropsychiatric symptoms and parkinsonian features. The physician reviewer found that in patients who have rapid cognitive decline or have symptoms that may mimic other neurodegenerative processes, PET scan is indicated to help differentiate between the conditions that are on the differential diagnosis. Molecular imaging with PET offers a broad variety of tools supporting the diagnosis of movement disorders. The more widely applied PET imaging techniques have focused on the assessment of neurotransmitter systems, predominantly the pre- and post-synaptic dopaminergic system. Additionally, PET imaging with fluorodeoxyglucose (18F) has been extensively utilized to assess local synaptic activity in the resting state and to highlight local changes in brain metabolism accompanying changes in neural activity in movement disorders. Given that the clinical documentation submitted for review, the PET scan performed on 2/3/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 47-year-old male enrollee has requested reimbursement for substance use residential treatment provided from 4/02/16 through 4/27/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
toxification. Upon admission, the patient had a normal mental status examination. He was well-groomed and cooperative. His thought process was coherent. His mood was normal while his affect was mood-congruent and appropriate. He denied any psychiatric history, aside from anxiety and poor sleep. He denied suicidal ideation and expressed motivation for recovery.
|
Upheld
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Medical Necessity
|
Summary Reviewer
A 47-year-old male enrollee has requested reimbursement for substance use residential treatment provided from 4/02/16 through 4/27/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found there is a lack of support for the services at issue in this clinical setting. Although chemical dependency specialty services were indicated, the medical records do not demonstrate the necessity of the residential level of care following detoxification. Upon admission, the patient had a normal mental status examination. He was well-groomed and cooperative. His thought process was coherent. His mood was normal while his affect was mood-congruent and appropriate. He denied any psychiatric history, aside from anxiety and poor sleep. He denied suicidal ideation and expressed motivation for recovery. The records do not demonstrate that the patient had engaged chemical dependency treatment services during the episode of illness, such as substance use counseling, anti-craving medication, sober living environments, community sponsorship, intensive outpatient programming or partial hospitalization. This is significant because modern psychiatric practice favors treatment in the community as outcome measures and therapeutic gains are optimized in this environment. In sum, the record does not reflect that comprehensive, evidence-based services provided in a less restrictive setting would have been inadequate at the time. Thus, substance use residential treatment provided from 4/02/16 through 4/27/16 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 70-year-old female enrollee has requested reimbursement for radiofrequency ablation of the right side performed on 5/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees varicose veins.
|
Overturned
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Experimental
|
Summary Reviewer 1
A 70-year-old female enrollee has requested reimbursement for radiofrequency ablation of the right side performed on 5/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees varicose veins. The physician reviewer found the submitted documentation fails to demonstrate the superior efficacy of the services at issue. There is a lack of documentation of a concerted effort to treat conservatively. It is noted that the anatomy of the accessory vein was likely not amenable to endovenous ablation. There is no evidence the patient was having activity limiting symptoms despite the use of compression stockings. In sum, radiofrequency ablation of the right side performed on 5/25/16 was not likely to be more efficacious than other treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
patient is a 43-year-old male with ongoing neck pain. The patient has requested
authorization and coverage for artificial disc arthroplasty.
In this case, the patient has
nerve root compression from degenerative disc disease.
|
Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 43-year-old male with ongoing neck pain. The patient has requested
authorization and coverage for artificial disc arthroplasty. The physician reviewer found that the
current medical evidence supports the medical necessity of the requested services in this clinical
setting. Kim and colleagues performed a prospective study of patients treated with cervical disc
arthroplasty for one-level and two-level pathology. The authors noted that the Results through
10 years were comparable to seven-year outcomes, demonstrating that cervical disc arthroplasty
with Mobi-C continues to be a safe and effective surgical treatment for patients with one- or two-
level cervical degenerative disc disease. The article by Gornet and colleagues supports the 10-
year efficacy of cervical disc arthroplasty compared to fusion surgery. In this case, the patient has
nerve root compression from degenerative disc disease. There is sufficient support for the
requested services in this setting. Therefore, the requested artificial disc arthroplasty is medically
necessary for the treatment of this patient.
| 1 |
A 21-year-old female enrollee has requested reimbursement for substance abuse residential services provided from 5/15/19 through 5/16/19. 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.
|
Overturned
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Medical Necessity
|
Summary Reviewer
A 21-year-old female enrollee has requested reimbursement for substance abuse residential services provided from 5/15/19 through 5/16/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the American Society of Addiction Medicine (ASAM) criteria for level of placement can be applied to the patients presentation to help determine whether the patient met criteria for residential care. With regards to dimension 1, acute intoxication and/ or withdrawal potential, the patient met this criteria due to withdrawal symptoms. In terms of dimension 2, biomedical condition and complications, the patient met this criteria due to active medical issues. With regards to dimension 3, emotional/behavioral or cognitive conditions and complications, the patient met this criteria due to anxiety and suicidal ideation. In terms of dimension 4, readiness to change, the patient met this criteria. With regards to dimension 5, relapse, continued use, or continued problem potential, the patient met this criteria based on the records. In terms of dimension 6, recovery/living environment, the patient also met this criteria per the clinical notes. Therefore, ASAM criteria were met for residential care. Thus, substance abuse residential services provided from 5/15/19 through 5/16/19 were medically necessary for the treatment of this patient.
| 0 |
The patient is a 64-year-old male with a diagnosis of hypogonadism since 2011. In a letter dated 1/21/16, the provider notes the patients symptoms include decreased libido, decreased energy, mood swings, fat accumulation, sleepiness, and reduced muscle mass. The patient has been treated with Testopel since August 2015. On 3/16/16, his testosterone level was 187. The patient is requesting reimbursement for Testopel implants provided on 1/21/16 and 5/26/16. The Health Insurer has denied this request as investigational. The Testopel impl
|
Overturned
|
Experimental
|
Summary Reviewer 3
The patient is a 64-year-old male with a diagnosis of hypogonadism since 2011. In a letter dated 1/21/16, the provider notes the patients symptoms include decreased libido, decreased energy, mood swings, fat accumulation, sleepiness, and reduced muscle mass. The patient has been treated with Testopel since August 2015. On 3/16/16, his testosterone level was 187. The patient is requesting reimbursement for Testopel implants provided on 1/21/16 and 5/26/16. The Health Insurer has denied this request as investigational. The Testopel implants provided on 1/21/16 and 5/26/16 were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Testosterone replacement therapy (TRT) is recommended for older men with either low serum testosterone or low testosterone plus accompanying symptoms of hypogonadism. Serum testosterone levels of less than 300 is considered to be low, and testosterone levels of less than 250 is considered to be frank hypogonadism. Most experts support TRT for older men with frank hypogonadism and symptoms. TRT produces a number of established benefits in hypogonadal men, including increased muscle mass and strength, decreased fat mass, increased bone mineral density, and improved sexual function. In this case, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 61-year-old female has requested authorization and coverage for 64568, 0466T and 95970. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea.
this patient has severe obstructive sleep apnea and has not been able to tolerate the CPAP device. She has septal deviation. She had a sleep endoscopy which showed anteroposterior collapse and minimal lateral collapse. The Inspire device has been
However, the patient has septal deviation which has not been treated surgically, and
|
Upheld
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Experimental
|
Summary Reviewer 2
A 61-year-old female has requested authorization and coverage for 64568, 0466T and 95970. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that this patient has severe obstructive sleep apnea and has not been able to tolerate the CPAP device. She has septal deviation. She had a sleep endoscopy which showed anteroposterior collapse and minimal lateral collapse. The Inspire device has been approved by the U.S. Food and Drug Administration for the treatment of obstructive sleep apnea. However, the patient has septal deviation which has not been treated surgically, and this can improve her ability to tolerate the CPAP device. At this point, she is not a candidate for the Inspire device. There is a lack of support for the requested services in this clinical setting. Thus, the requested services (64568, 0466T and 95970) are not likely to be of greater benefit than 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 43-year-old female enrollee has requested reimbursement for residential treatment center services provided from 5/27/17 through 6/26/17. The Health Plan has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
. The patient does not have any prior history of suicide attempts. On admission, the patient did not have any suicidal ideation. The patient was able to care for herself. The patient did not have any legal problems. The patients functional status score is three (3), moderate impairment. The patients substance use led her to lose her job. She was unable to fulfill responsibilities and obligations in her job.
. The patient has a significant co-morbidity of alcohol use disorder, depression, migraine headaches, and hypertension.
, mildly stressful environment. The patient is single and has two children, ages 10 and 13. Potential for alcohol exposure exists at her home.
. The patients parents are supportive of the patient. The patient also has community support in Alcoholics Anonymous. The patients treatment history score is three (3), moderate response to treatment and recovery. The patients prior treatments have been modestly successful. She had obtained five months of sobriety prior to the
|
Upheld
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Medical Necessity
|
Summary Reviewer
A 43-year-old female enrollee has requested reimbursement for residential treatment center services provided from 5/27/17 through 6/26/17. The Health Plan has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that based on the Level of Care Utilization System (LOCUS) criteria, as of 5/27/17, the patient met criteria for treatment in a less restrictive environment. The patients risk of harm score is two (2), low risk of harm. The patient does not have any prior history of suicide attempts. On admission, the patient did not have any suicidal ideation. The patient was able to care for herself. The patient did not have any legal problems. The patients functional status score is three (3), moderate impairment. The patients substance use led her to lose her job. She was unable to fulfill responsibilities and obligations in her job. The patients medical, addictive and psychiatric co-morbidity score is three (3), significant co-morbidity. The patient has a significant co-morbidity of alcohol use disorder, depression, migraine headaches, and hypertension. The patients recovery environment score is two (2), mildly stressful environment. The patient is single and has two children, ages 10 and 13. Potential for alcohol exposure exists at her home. The patients level of support score is two (2), supportive environment. The patients parents are supportive of the patient. The patient also has community support in Alcoholics Anonymous. The patients treatment history score is three (3), moderate response to treatment and recovery. The patients prior treatments have been modestly successful. She had obtained five months of sobriety prior to the residential treatment center admission. The patient also had 70 days of sobriety while receiving treatment as an outpatient. The patients engagement and recovery status score is two (2), positive engagement and recovery. The patient was motivated for recovery and cooperative with staff. She would accept and participate in treatment. Based on these criteria, the patient had a total score of 17 and met criteria for an intensive outpatient program (IOP). Therefore, the residential treatment center services provided from 5/27/17 through 6/26/17 were not medically necessary for treatment of the patients medical condition. 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 78-year-old female enrollee has requested authorization and coverage for positron emission tomography (PET) imaging and magnetic resonance imaging (MRI) of the bilateral breasts. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition.
|
Overturned
|
Medical Necessity
|
Summary Reviewer
A 78-year-old female enrollee has requested authorization and coverage for positron emission tomography (PET) imaging and magnetic resonance imaging (MRI) of the bilateral breasts. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested MRI of the bilateral breasts. The literature does not recommend the use of breast MRI as a replacement for routine breast mammography and ultrasound. MRI studies of the breast are highly sensitive, but have a relatively low level of specificity. In this particular patient, the medical evidence does not support MRI of the bilateral breasts. The only indicator in this patient that something might be amiss is the elevated tumor marker. While breast MRI is becoming increasingly commonplace, there is insufficient data available to support its use as a routine screening study in patients with a relatively average risk of developing breast cancer. However, there is sufficient support for the requested PET imaging in this clinical setting. In this case, since the elevated tumor marker was identified, and the referring provider believed it was necessary to explore the possibility of recurrence, simple imaging was performed. The CT scan and the bone scan were inconclusive. Advanced imaging such as PET scanning may be warranted for patients in which conventional imaging is inconclusive. If further investigation of the elevated tumor marker is felt to be clinically indicated, PET scan is appropriate. Although the small lesions seen in the lung bases are likely too small to be metabolically active, there is some value in searching for other sites of occult tumor such as the bones. In sum, the requested PET imaging is medically necessary. However, the requested MRI of the bilateral breasts is not medically indicated for the evaluation of this patient. Therefore, a portion of the requested services is medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be partially overturned.
| 0 |
A 62-year-old male enrollee has requested authorization and coverage for patent foramen ovale (PFO) closure. 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 had a recent transient ischemic attack while flying on an airplane. He was evaluated and has no other reason for transient ischemic attack other than the patent foramen ovale.
|
Upheld
|
Experimental
|
Summary Reviewer 1
A 62-year-old male enrollee has requested authorization and coverage for patent foramen ovale (PFO) closure. 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 this patient had a recent transient ischemic attack while flying on an airplane. He was evaluated and has no other reason for transient ischemic attack other than the patent foramen ovale. In addition, the development of the transient ischemic attack symptoms while flying a high altitude makes the patent foramen ovale an even more likely etiology of the symptoms as right heart pressures increase at high altitudes, and the risk of transient deep vein thrombosis is higher as well. This combination (occult deep vein thrombosis with elevated right heart pressures because of lower air pressures) makes the likelihood of paradoxical embolism from increased right to left shunting significantly higher in the setting of a large patent foramen ovale. This adds further credence to the clinical suspicion of the patent foramen ovale being the culprit pathology of the transient ischemic attack in this case. Recent data and meta-analyses suggest that patent foramen ovale closure prevents recurrent crytogenic stroke better than medical therapy alone in patients with no other suspected cause of the stroke and likely transient ischemic attacks as well. Therefore, patent foramen ovale closure is likely to be more beneficial than any available standard therapy.
| 1 |
A 28-year-old female enrollee has requested reimbursement and prospective authorization and
coverage for ketamine infusions from 9/07/21 forward. The Health Insurer has denied this
request and reported that the services at issue were and are investigational for the treatment of
the enrollees medical condition.
ychotherapies, and transcranial
magnetic stimulation. The patient needed a residential level of care prior to ketamine infusion.
After ketamine treatment, she was able to be discharged to the outpatient level of care and has
had symptomatic and functional improvement.
|
Overturned
|
Experimental
|
Summary Reviewer 3
A 28-year-old female enrollee has requested reimbursement and prospective authorization and
coverage for ketamine infusions from 9/07/21 forward. The Health Insurer has denied this
request and reported that the services at issue were and are investigational for the treatment of
the enrollees medical condition. The physician reviewer found that the records note multiple
failed trials of antidepressants, augmentation agents, psychotherapies, and transcranial
magnetic stimulation. The patient needed a residential level of care prior to ketamine infusion.
After ketamine treatment, she was able to be discharged to the outpatient level of care and has
had symptomatic and functional improvement. For patients with severe, treatment-resistant,
unipolar, major depression without psychotic features who decline electroconvulsive therapy,
ketamine is a reasonable alternative to antidepressants. Ketamine may be particularly helpful for
patients with refractory, active suicidal ideation. Evidence supporting short-term use of ketamine
for severe, treatment-resistant, unipolar, major depression without psychotic features includes
multiple analyses of randomized trials that consistently demonstrate ketamine can rapidly
improve depression for a relatively short period of time, and that the drug is relatively well-
tolerated. Thase and Connolly noted, Randomized trials have demonstrated that intravenous
ketamine and intranasal esketamine can each rapidly improve treatment-resistant depression,
including symptoms of suicidal ideation. Per the authors, For unipolar major depression, the
efficacy of esketamine and ketamine appear to be comparable. However, no head-to-head trials
comparing the two drugs have been published. Given that this patient has responded to her
current treatment regimen of ketamine, it is appropriate to continue with this treatment rather
than subjecting her to a trial of esketamine as an alternative. The medical evidence supports the
services at issue in this clinical setting. Therefore, ketamine infusions from 9/07/21 forward were
and are likely to be more beneficial than any available standard therapy.
| 1 |
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.
|
Upheld
|
Experimental
|
Summary Reviewer 2
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 the DecisionDx-Melanoma test is a clinically validated prognostic tool for patients with stage 1A disease, who are not recommended for sentinel node biopsy. Traditional clinical pathologic assessment for determination of prognosis based on tumor size, and histopathologic features as described in this patients biopsy report, underreport a significant percentage of stage 1 and 2 patients who subsequently present with recurrent disease and metastases with incurable melanoma. The DecisionDx-Melanoma test has been used as a standard method for prognosis assessment, based on multiple publications detailing the test utility in melanoma patients. The DecisionDx-Melanoma test is an independent predictor of risk. In sum, testing (DecisionDx-Melanoma Gene Assay) performed on 7/31/18 was likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
The patient is a 29-year-old female who presented to the emergency department on 6/6/22 with clinical
and radiographic appendicitis. An operative report dated 6/7/22 reported a diagnosis of acute
appendicitis.
In
this case, the patient had clinical and radiographic appendicitis, and an appendectomy, the
|
Overturned
|
Medical Necessity
|
Summary Reviewer
The patient is a 29-year-old female who presented to the emergency department on 6/6/22 with clinical
and radiographic appendicitis. An operative report dated 6/7/22 reported a diagnosis of acute
appendicitis. The physician reviewer found that at issue is whether inpatient hospital charges from
6/6/22 through 6/7/22 were medically necessary for the treatment of this patient. The submitted
documentation supports the medical necessity of the services at issue. Moris and colleagues note that
the clinical diagnosis of acute appendicitis is based on history and physical, laboratory evaluation, and
imaging, and that appendectomy remains first-line therapy for acute appendicitis, but treatment with
antibiotics rather than surgery is appropriate in selected patients with uncomplicated appendicitis. In
this case, the patient had clinical and radiographic appendicitis, and an appendectomy, the preferred
treatment, was appropriately recommended and performed. A pathology report confirmed appendicitis.
In this clinical setting, given the patients acute illness with unplanned surgery for acute appendicitis, the
service at issue was medically indicated. Therefore, inpatient hospital charges from 6/6/22 through
6/7/22 were medically necessary for the treatment of this patient.
| 1 |
The parent of a 12-year-old male enrollee has requested authorization and coverage for real-time intra-fraction target tracking for planned proton beam radiotherapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees craniopharyngioma status post resection.
based on the medical records, the tumor was in intimate contact with the optic apparatus. The organ surface is at risk for harboring microscopic disease.
|
Overturned
|
Experimental
|
Summary Reviewer 3
The parent of a 12-year-old male enrollee has requested authorization and coverage for real-time intra-fraction target tracking for planned proton beam radiotherapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees craniopharyngioma status post resection. The physician reviewer found that based on the medical records, the tumor was in intimate contact with the optic apparatus. The organ surface is at risk for harboring microscopic disease. The optic apparatus needs to be radiated in order to maximize the effectiveness of radiation therapy in disease control. However, avoiding the optic apparatus is not needed and the requested real-time intra-fraction target tracking for planned proton beam radiotherapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined 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 60-year-old female enrollee has requested authorization and coverage for percutaneous or
endoscopic spinal surgery. The Health Insurer has denied this request and reported that the
requested services are investigational for the treatment of the enrollees medical condition.
that this patient has been treated for spinal stenosis, lumbar region with
neurogenic claudication; chronic pain syndrome; complex regional pain syndrome I of left lower
limb; and post- laminectomy syndrome. She presented with worsening low back pain.
|
Overturned
|
Experimental
|
Summary Reviewer 1
A 60-year-old female enrollee has requested authorization and coverage for percutaneous or
endoscopic spinal surgery. 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 this patient has been treated for spinal stenosis, lumbar region with
neurogenic claudication; chronic pain syndrome; complex regional pain syndrome I of left lower
limb; and post- laminectomy syndrome. She presented with worsening low back pain. There is
current evidence-based medical literature support for the use of this procedure for the treatment of
spinal stenosis, as compared to lumbar epidural steroid injection. However, in this case, there are
no clinical examination findings documented and no clear discussion to support minimally
invasive surgery over standard lumbar decompression in the setting of thickening of the ligament
flavum, bilateral foraminal protrusions, cross-sectional area of the central canal measuring
approximately 50 square mm, severe canal stenosis and bilateral lateral recess stenosis, which
cannot typically be fully addressed with minimally invasive surgery. Therefore, percutaneous or
endoscopic spinal surgery is not likely to be more beneficial than any available standard therapy.
| 1 |
A 61-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees colorectal cancer with liver metastases.
|
Upheld
|
Experimental
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Summary Reviewer 1
A 61-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees colorectal cancer with liver metastases. The physician reviewer found that the American Society for Radiation Oncology (ASTRO) acknowledges the need for proton therapy when strongly justified by a dosimetric rationale such as specific dose-volume parameters for the target and nearby structures. Pelvic malignancies including gastrointestinal carcinomas are currently being evaluated and comparative efficacy evidence is being developed. In order for toxicity risks to be reduced, there should be a clinically significant reduction in dose to critical structures, with an evidence basis of benefit with dose reduction. However, the case records do not adequately demonstrate the need for proton therapy using dosimetric evidence. This is important in justifying the need for proton therapy in clinical scenarios for which proton therapy is not considered the standard of care. There is no documentation that a conventional three-dimensional (3D) conformal plan or intensity modulated radiation therapy (IMRT) would be unacceptable. All told, the requested proton beam radiation therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 53-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene expression testing performed on 11/01/18. 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 53-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene expression testing performed on 11/01/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma assay 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. The test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, DecisionDx-Melanoma gene expression testing performed on 11/01/18 was not likely to have been more beneficial than any available standard therapy.
| 0 |
A 56-year-old female enrollee has requested reimbursement for the hip surgery (CPT codes 29914 and 29915) provided on 6/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees right hip impingement syndrome.
In this case, the patient is a physical trainer who performed activity modification and independent exercise, underwent chiropractic care, and was treated with nonsteroidal anti-inflammatory medications and opioid pain medications. The 4/23/16 magnetic resonance imaging (MRI) was interpreted as demonstrating moderate
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Overturned
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Experimental
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Summary Reviewer 3
A 56-year-old female enrollee has requested reimbursement for the hip surgery (CPT codes 29914 and 29915) provided on 6/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees right hip impingement syndrome. The physician reviewer found that Femoroacetabular impingement is recognized as a common cause of hip pain resulting from abnormal contact between the proximal femur and acetabular rim. Abnormalities can be identified on either the femoral or acetabular side, but are most commonly seen on both sides. Harris and colleagues demonstrated that surgical treatment is effective and recommended in patients who fail to improve with routine conservative therapy. In this case, the patient is a physical trainer who performed activity modification and independent exercise, underwent chiropractic care, and was treated with nonsteroidal anti-inflammatory medications and opioid pain medications. The 4/23/16 magnetic resonance imaging (MRI) was interpreted as demonstrating moderate to high grade cartilage loss, but that appears to have been an overestimate based on the preoperative x-rays and operative findings documented in the surgical report. The 4/26/16 x-rays did not reveal substantial cartilage space narrowing. All told, the hip surgery (CPT codes 29914 and 29915) provided on 6/17/16 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of a 12-year-old female enrollee has requested authorization and coverage for surgery (ApiFix procedure). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
This patient has been diagnosed with adolescent idiopathic scoliosis. She had presented in consultation for scoliosis. She had not had any scoliosis intervention. She has been wearing her brace. Clinical and radiographic findings evidence a significant
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Overturned
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Experimental
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Summary Reviewer 2
The parent of a 12-year-old female enrollee has requested authorization and coverage for surgery (ApiFix procedure). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. At issue is whether the requested services are likely to be more beneficial for treatment of the enrollees condition than any available standard therapy. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the requested services in this setting. Stadhouder and colleagues noted, The use of the unilateral peri-apical concave self-distracting ratchet rod initially was associated with promising clinical and radiographic results. However, no distraction was observed and the high rate of serious adverse events within 2 years was considered to be unacceptable for further clinical application of this device in our institution, despite recent FDA approval. Cheung and colleagues noted, Various emerging techniques in the surgical treatment of idiopathic scoliosis in children and adolescents have demonstrated promising results in the reported data thus far. However, longer term prospective studies with larger cohorts are necessary to better evaluate their safety and efficacy. This patient has been diagnosed with adolescent idiopathic scoliosis. She had presented in consultation for scoliosis. She had not had any scoliosis intervention. She has been wearing her brace. Clinical and radiographic findings evidence a significant probability of ongoing major spinal curve progression. However, overall published quality, peer-reviewed literature does not support or evidence the request to be an effective and/or safe treatment for adolescent idiopathic scoliosis. Further studies are needed to adequately demonstrate the overall safety and/or efficacy of the requested ApiFix. Therefore, the requested surgery (ApiFix procedure) is not likely to be more beneficial than other available standard therapy.
| 1 |
The patient is a 66-year-old male with a history of lower extremity swelling, hypertension, coronary artery disease, and hyperlipidemia. A lower extremity venous mapping ultrasound on 6/13/17 demonstrated no evidence of deep vein thrombosis (DVT). The bilateral greater saphenous veins were ablated. The right short saphenous vein was 4.2 mm with four seconds of reflux. A right medial distal calf perforator was noted with reflux. The left short saphenous vein was 7.5 mm with three seconds of reflux. There was a left medial distal calf perforator noted with reflux. Based on these results, the plan was for radiofrequency ablation (RFA) of bilateral short saphenous veins with RFA of bilateral medial distal calf perforators and ultrasound-guided sclerotherapy of varicose vein tributaries. The patient was treated with compression stockings. On 8/11/17, the provider noted the patient reports leg pains, achiness in the legs, night cramps, restless legs, leg swelling, and chronic skin color changes. The patients symptoms are interfering with his ability to perform activities of daily living. On physical examination, no clubbing or cyanosis is noted. There is bilateral ankle edema, left greater than right. The patient has requested authorization and coverage for endovenous vein ablation. The Health Insurer has denied this request indicating that the requested services are considered investigational.
patients current symptoms are due to his short saphenous vein reflux. The patient has not been reevaluated since he was treated with compression stockings and there
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Upheld
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Experimental
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Summary Reviewer 1
The patient is a 66-year-old male with a history of lower extremity swelling, hypertension, coronary artery disease, and hyperlipidemia. A lower extremity venous mapping ultrasound on 6/13/17 demonstrated no evidence of deep vein thrombosis (DVT). The bilateral greater saphenous veins were ablated. The right short saphenous vein was 4.2 mm with four seconds of reflux. A right medial distal calf perforator was noted with reflux. The left short saphenous vein was 7.5 mm with three seconds of reflux. There was a left medial distal calf perforator noted with reflux. Based on these results, the plan was for radiofrequency ablation (RFA) of bilateral short saphenous veins with RFA of bilateral medial distal calf perforators and ultrasound-guided sclerotherapy of varicose vein tributaries. The patient was treated with compression stockings. On 8/11/17, the provider noted the patient reports leg pains, achiness in the legs, night cramps, restless legs, leg swelling, and chronic skin color changes. The patients symptoms are interfering with his ability to perform activities of daily living. On physical examination, no clubbing or cyanosis is noted. There is bilateral ankle edema, left greater than right. The patient has requested authorization and coverage for endovenous vein ablation. The Health Insurer has denied this request indicating that the requested services are considered investigational. The documentation does not demonstrate that this patients current symptoms are due to his short saphenous vein reflux. The patient has not been reevaluated since he was treated with compression stockings and there is no documentation that he has been using them regularly. Moreover, there is no documentation of adequate lower extremity arterial perfusion in this patient with a history of coronary artery disease, hyperlipidemia, hypertension, and leg pain. Given these findings, the requested endovenous vein ablation is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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patient is a 51-year-old female who underwent a colonoscopy on 5/10/19 for the indication of colorectal cancer screening. Per the records, this revealed two polyps (which were removed) and internal hemorrhoids.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 51-year-old female who underwent a colonoscopy on 5/10/19 for the indication of colorectal cancer screening. Per the records, this revealed two polyps (which were removed) and internal hemorrhoids. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. According to the American Society of Anesthesiologists guidelines for anesthesia care during endoscopic procedures, monitored anesthesia care is warranted in prolonged or painful procedures, such as complex polyp resections, endoscopic retrograde cholangiopancreatography or other biliary procedures, endoscopic dilation, or endoscopic resection. Additionally, the guidelines state that monitored anesthesia care is more likely necessary in patients with failed history of moderate sedation for the procedure or psychological impediments to cooperation. The provided records do not support any of these criteria, or other criteria in the literature, such as difficult intubation, airway obstruction, allergies to sedation medications, chronic alcohol or illicit drug use resulting in increased tolerance to sedation medications, age greater than 70, pregnancy, increased aspiration risk, American Society of Anesthesiologists (ASA) class III or higher, or morbid obesity. According to the most recent guidelines from the American Society for Gastrointestinal Endoscopy, during endoscopic procedures (unlike surgery), consciousness during the procedure is
acceptable and is the goal during most procedures. Monitored anesthesia care is recommended for prolonged procedures requiring deep sedation, previously anticipated intolerance to standard sedatives, ASA class IV or V, or risk for airway obstruction due to anatomic variant. All told, monitored anesthesia care provided on 5/10/19 was not medically necessary for the treatment of this patient.
| 1 |
A 52-year-old female enrollee has requested authorization and coverage for endovenous ablation. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees varicose veins.
documentation, the patient has symptoms which are impacting her activities of daily living. In a letter dated 4/12/16, the provider noted bilateral leg pain, swelling, numbness, throbbing, and aching when standing.
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Overturned
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Medical Necessity
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Summary Reviewer
A 52-year-old female enrollee has requested authorization and coverage for endovenous ablation. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees varicose veins. The physician reviewer found there is sufficient support for the requested services in this clinical setting. Per the submitted documentation, the patient has symptoms which are impacting her activities of daily living. In a letter dated 4/12/16, the provider noted bilateral leg pain, swelling, numbness, throbbing, and aching when standing. The current medical evidence supports the requested services for the treatment of this patient. All told, the requested endovenous ablation is medically indicated in this patients case. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The patient is a 35-year-old female who is pregnant. The patient has requested authorization and coverage for Makena injection (hydroxyprogesterone caproate 10 mg). 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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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 35-year-old female who is pregnant. The patient has requested authorization and coverage for Makena injection (hydroxyprogesterone caproate 10 mg). The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. The physician reviewer found that the literature supports the use of progesterone treatment to decrease the risk of preterm delivery in a patient who has a history of preterm birth. Research has shown that a prior spontaneous preterm birth is a risk factor for a subsequent spontaneous preterm birth, whether the initial preterm delivery was a singleton or a twin pregnancy. Although no study has specifically evaluated whether progesterone supplementation decreases the risk of a preterm birth of a singleton after a previous spontaneous preterm birth of twins, it is appropriate for providers to recommend this therapy. There is a theoretical benefit given available data. This provider is practicing within current standard of care, and progesterone therapy is appropriate in this clinical setting. Therefore, Makena injection (hydroxyprogesterone caproate 10 mg) is medically necessary for the treatment of this patient.
| 1 |
A 61-year-old enrollee has requested authorization and coverage for clobetasol ointment. 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 been diagnosed with lichen sclerosus et atrophicus involving the genital skin. Lichen sclerosus
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Overturned
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Medical Necessity
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Summary Reviewer
A 61-year-old enrollee has requested authorization and coverage for clobetasol ointment. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested medication in this clinical setting. This patient has been diagnosed with lichen sclerosus et atrophicus involving the genital skin. Lichen sclerosus et atrophicus is a chronic inflammatory condition. If left untreated, this can lead to squamous cell carcinoma. Treatment with ultrapotent topical steroids is recommended to reduce inflammation. Clobetasol ointment is an ultrapotent topical steroid commonly used for the treatment of lichen sclerosus et atrophicus. Therefore, clobetasol ointment is medically necessary for the treatment of this patient.
| 1 |
A 61-year-old female has requested reimbursement for code 73721, magnetic resonance imaging (MRI) lower extremity, any joint, without contrast, performed on 6/12/19. 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.
An MRI was performed on 6/12/19 and showed medial collateral ligament (MCL) and anterior cruciate ligament (ACL) disruption consistent with internal derangement. This patient had clinical findings of knee instability, per the history given to the radiologist.
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Overturned
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Medical Necessity
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Summary Reviewer
A 61-year-old female has requested reimbursement for code 73721, magnetic resonance imaging (MRI) lower extremity, any joint, without contrast, performed on 6/12/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the services at issue in this clinical setting. An MRI was performed on 6/12/19 and showed medial collateral ligament (MCL) and anterior cruciate ligament (ACL) disruption consistent with internal derangement. This patient had clinical findings of knee instability, per the history given to the radiologist. Per the current guidelines, knee instability, decreased range of motion and joint effusion are valid indications for MRI without antecedent six weeks of conservative therapy. There is sufficient support for the services at issue in this clinical setting. Therefore, MRI lower extremity, any joint, without contrast performed on 6/12/19 was medically necessary for the evaluation of this patient.
| 1 |
The parent of a 16-year-old male enrollee has requested authorization and coverage for mastectomy. The Health Insurer has denied this request indicating that the requested surgery is not medically necessary for treatment of the enrollees gender dysphoria.
ysphoria. This patient has well documented gender dysphoria including a letter of support for surgery from his mental health professional and his pediatric endocrinologist who are part of a qualified multid
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 16-year-old male enrollee has requested authorization and coverage for mastectomy. The Health Insurer has denied this request indicating that the requested surgery is not medically necessary for treatment of the enrollees gender dysphoria. The physician reviewer found that the World Professional Association for Transgender Health (WPATH) Standards of Care (SOC) acknowledges that for certain patients, an intervention like a reduction rhinoplasty can have a radical and permanent effect on their quality of life, and therefore is much more medically necessary than for somebody without gender dysphoria. WPATHs SOC further states that while most professionals agree that genital surgery and mastectomy cannot be considered purely cosmetic, opinions diverge as to what degree other surgical procedures (e.g., breast augmentation, facial feminization surgery) can be considered purely reconstructive. Although it may be much easier to see a phalloplasty or a vaginoplasty as an intervention to end lifelong suffering, for certain patients, an intervention like a reduction rhinoplasty can have a radical and permanent effect on their quality of life, and therefore is much more medically necessary than for somebody without gender dysphoria. This patient has well documented gender dysphoria including a letter of support for surgery from his mental health professional and his pediatric endocrinologist who are part of a qualified multidisciplinary team. He currently meets the WPATH SOC criteria as well as the Endocrine Society guideline criteria for breast surgery. The patients parents, medical providers, mental health provider, and surgical providers are supportive. Thus, the requested mastectomy is medically necessary to align his body with his gender identity and help alleviate the distress associated with gender dysphoria. Based on the foregoing discussion, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 58-year-old female enrollee has requested reimbursement for Monovisc knee injections provided on 5/18/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees knee osteoarthritis.
long after the exogenous injection has left the joint. This patient has reported excellent results with prior hyaluronic acid injections.
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Overturned
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Medical Necessity
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Summary Reviewer
A 58-year-old female enrollee has requested reimbursement for Monovisc knee injections provided on 5/18/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees knee osteoarthritis. The physician reviewer found that there is adequate evidence that intraarticular hyaluronic acid injections reduce pain and increase function in knee osteoarthritis. In addition, the benefits of hyaluronic acid are long-lasting as compared with intraarticular corticosteroids. In a systematic review of meta-analyses, Campbell and colleagues compared hyaluronic acid injections with other non-operative treatment modalities for knee osteoarthritis. The authors found that intraarticular hyaluronic acid improves knee pain and function for up to 26 weeks. Moreover, Maheu and colleagues noted that the benefits of intraarticular hyaluronic acid on knee osteoarthritis may include mechanical viscosupplementation of the joint (allowing lubrication and shock absorption) andthe re-establishment of joint homeostasis through induction of endogenous HA [hyaluronic acid] production, which continues long after the exogenous injection has left the joint. This patient has reported excellent results with prior hyaluronic acid injections. All told, the Monovisc knee injections provided on 5/18/18 were medically necessary for treatment of this patients bilateral knee osteoarthritis. Based on the foregoing discussion, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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