Persius/imr-appeals huggingface dataset:
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 70-year-old male enrollee has requested authorization and coverage for DecisionDx-Melanoma testing performed on 10/28/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that there is a lack of support in the medical literature for the services at issue in this patients case. DecisionDx-Melanoma assay claims to determine risk of recurrence for early melanoma as in this patient. However, there is a lack of data to support using adjuvant therapy in similar patients based on risk of recurrence. Adjuvant therapy is based on stage and not on the risk of recurrence as determined by this test. Moreover, the literature does not support a therapeutic advantage of this test over the standard options since this test is not designed to change or alter therapy nor alter surveillance regardless of risk. Furthermore, prospective randomized data for determination of recurrence is lacking in this test. All told, DecisionDx-Melanoma gene expression test performed on 10/28/16 was not likely to have been superior over other methods of evaluating this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2


A 40-year-old female enrollee has requested reimbursement for the Decision Dx test and specimen handling provided on 11/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that 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 suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha (Balch, et al). There is a paucity of data on the Decision Dx test to be incorporated into the treatment algorithm beyond standard staging techniques. Accordingly, the Decision Dx test and specimen handling provided on 11/23/15 were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 33-year-old female enrollee has requested reimbursement for the unlisted chemistry procedure (Decision Dx testing) provided on 10/30/15. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees cutaneous melanoma. The physician reviewer found the unlisted chemistry procedure (Decision Dx testing) provided on 10/30/15 was not medically necessary for evaluation of the patients medical condition. Decision Dx testing was developed from ocular melanoma samples and it has not been established in the peer-reviewed literature that this data applies to cutaneous melanoma as well. Use of this testing is not considered the standard of care. The National Comprehensive Cancer Network (NCCN) guidelines recommend that Decision Dx testing should not be performed outside of a clinical trial setting. Based on the lack of support in the peer-reviewed literature and national guidelines, the testing at issue has not been established as medically necessary for evaluation of the patients melanoma. Therefore, the testing at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 38-year-old female enrollee has requested reimbursement and prospective authorization and coverage for substance use residential rehabilitation from 11/14/16 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 submitted documentation fails to demonstrate the medical necessity of the services at issue.  This patient had a low risk of harm, as she denied any suicidal thoughts or plans, but occasionally had transient suicidal thoughts.  She had no prior suicide attempts.  Per the records, the patient had some moderate impairment in her functional status.  The documentation noted ongoing substance use despite negative consequences.  She also has comorbid general anxiety disorder.  The clinical notes indicates limited support.  The patient has maintained partial recovery for moderate periods of time, but only with strong professional and peer support.  Based upon the provided documentation, the patient appears to have had difficulties engaging in treatments at times.  However, recently she appears to be more motivated for treatment as her family and job are in jeopardy due to the patients current substance use.  Based on the American Association of Community Psychiatrists Level of Care Utilization System, the patient meets criteria for partial hospitalization program level of care.  In sum, substance use residential rehabilitation from 11/14/16 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.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

The patient is a 47-year-old male with a medical history including obesity and hypertension. Per the records, he has been treated with Saxenda since March 2020. The physician reviewer found that according to the U.S. Food and Drug Administration (FDA), Saxenda is approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, dyslipidemia). The initial management of individuals who would benefit from weight loss is a comprehensive lifestyle intervention: a combination of diet, exercise, and behavioral modification. All patients who would benefit from weight loss should receive counseling on diet, exercise, and goals for weight loss. When a patient with a BMI greater than 30kg/m2 or a BMI of 27-29.9 kg/m2 with comorbidities, such as hypertension or diabetes Mellitus, has failed to achieve weight loss goals through diet and exercise alone, a pharmacologic therapy
is suggested. In this case, the documentation does not support that the patient has failed treatment with counseling, calorie restriction and increased physical activity to achieve weight loss goals. Therefore, Saxenda pen injector 6 mg/mL is not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 53-year-old female enrollee has requested reimbursement for the Foundation One genetic testing performed on 1/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees serous papillary carcinoma. The physician reviewer found that serous papillary carcinoma is a malignant histologic sub-type uterine carcinoma that have a propensity to spread within the peritoneum or by lymphovascular invasion. Standard practice is to initiate systemic therapy with adjuvant intent if all macroscopic disease is removed or systemic with palliative intent if the provider is unable to remove all disease. Current guidelines suggest that there are a number of systemic therapy and hormone therapy options that can be considered. There is limited data regarding the benefit of subsequent treatment for patients who progress despite two prior regimens. Thus, tumor molecular assessment is the only effective means to assess the patients therapeutic options. For these reasons, the Foundation One genetic testing performed on 1/25/17 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1 
 
A 49-year-old female insured has requested authorization and coverage for thermal destruction of 
intraosseous basivertebral nerve including all imaging guidance; first two vertebral bodies, lumbar 
(CPT 64628). The insureds symptoms are having a significant impact on activities of daily living 
such as household chores, leisure activities, sleeping, and work. Medications have included 
acetaminophen,  Celebrex,  meloxicam,  naproxen,  and  muscle  relaxants.  The  Health  Insurer 
indicates the requested services are considered investigational for the treatment of the insureds 
medical condition. Therefore, the Health Plan has denied coverage for the requested treatment. 
This denial is the subject of this appeal and determination. The physician reviewer found that a 
randomized controlled trial evaluating the effectiveness of intraosseous radiofrequency ablation of 
the basivertebral nerve to standard care for the treatment of chronic low back pain in a specific 
subgroup of patients suspected to have vertebrogenic-related symptomatology was conducted 
(Khalil, et al.). The authors noted that there was a clear statistical superiority for all primary and 
secondary patient-reported outcome measures in the radiofrequency ablation patients outcomes 
compared with the standard of care. Moreover, Fischgrund and colleagues concluded that patients 
with  chronic  low  back  pain  who  underwent  treatment  with  radiofrequency  ablation  of  the 
basivertebral nerve reported clinically meaningful improvements in both Oswestry Disability 
Index (ODI) and Visual Analog Scale (VAS) scores at two-year follow-up. The International 
Society for the Advancement of Spine Surgery noted that basivertebral nerve ablation can be 
beneficial for patients with chronic low back pain that has not improved despite at least six months 
of non-surgical management and with Modic changes on at least one endplate on MRI (Lorio, et 
al.). In this case, the patient has had a history of chronic low back pain that has persisted for several 
years and has been refractory to multiple modes of standard care including physical therapy, 
exercise, anti-inflammatory medications, and spine injections. Multiple randomized controlled 
trials comparing basivertebral nerve ablation to the current standard of care support the procedure 
as superior in improving pain scores and disability scores. For these reasons, the requested thermal 
destruction of intraosseous basivertebral nerve including all imaging guidance; first two vertebral 
bodies, lumbar (CPT 64628) is likely to be more beneficial for the treatment of the patients 
medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 31-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/11/19. 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 had 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.  There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. All told, DecisionDx-Melanoma testing performed on 12/11/19 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 35-year-old male enrollee has requested reimbursement for the osteogenesis stimulator provided on 11/30/16. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees right ankle pain. The physician reviewer found that as noted in the medical literature, an accessory navicular is the most common extra ossicle of the foot. In cases of failed nonsurgical treatment, excision of the ossicle has been demonstrated to be effective (Jegal, et al; Rietveld and Diemer). Similarly, Marcus and Kopp found that when conservative measures fail to relieve the symptoms of a painful accessory navicular, simple excision of the accessory navicular and anatomic repair of the posterior tibialis tendon is a successful intervention. In addition, there is a lack of scientific evidence supporting the efficacy of ultrasound stimulation for treatment of foot and ankle pain in this clinical setting. All told, the osteogenesis stimulatory provided on 11/30/16 was not medically necessary for treatment of this patients foot pain. Based on the foregoing discussion, the device at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 56-year-old male enrollee has requested reimbursement for the Cologuard test provided on 12/1/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found that the Cologuard test provided on 12/1/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Colorectal neoplasms shed DNA in the stool from which the DNA can be isolated and tested for the presence of mutations and epigenetic changes acquired during carcinogenesis. Cologuard, which is a second generation stool DNA test combines stool DNA testing using a gene amplification technique to allow detection of low frequency mutations with increased sensitivity for advanced adenomas, for patterns of DNA methylation with testing for hemoglobin (Ahlquist, et al). Imperiale and colleagues compared stool DNA test with a fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. The authors found that the sensitivity for colorectal cancer of the stool DNA and FIT tests were 92.3% and 73.8% respectively. Given the support in the peer-reviewed literature, the testing at issue has been established as likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 59-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/30/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who presented for a breast examination.  The physician reviewer found that there is evidence based support for the service at issue in this clinical setting. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in callbacks and biopsies and an increase in detection of small cancers when compared to two dimensional imaging alone. Breast tomosynthesis provides advantages to radiologists interpreting mammograms. Therefore, the addition of digital breast tomosynthesis, to the usual two dimensional protocol was likely to be more effective than had her examination been performed using two dimensional imaging alone. Based upon the information set forth above, the service at issue was likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1 
 
A 49-year-old male enrollee has requested authorization and coverage for 0424T insertion 
neurostimulator system for central sleep apnea. The Health Insurer has denied this request and 
reported that the requested service is investigational for the treatment of the enrollees central 
sleep apnea. The physician reviewer found that in this case, the patient has severe central sleep 
apnea. Notes dated 6/18/22 reported an apnea-hypopnea index (AHI) of 35 with significant 
daytime  sleepiness.  The  patient  was  noted  as  being  a  highway  maintenance  worker,  an 
occupation posing high risk of injury to himself or others. The 0424T phrenic neurostimulator 
system is an implantable device that stimulates the diaphragm to contract, resulting in patients 
breathing, and is an option in selected patients with symptomatic central sleep apnea intolerant 
of CPAP or other standard therapies. While the device is approved by the U.S. Food and Drug 
Administration, (FDA), there may be a need for additional studies on cardiovascular outcomes 
and long-term safety in relation to other therapies for central sleep apnea. However, in this 
clinical setting, as the records indicate that the patient is unable to tolerate standard therapy 
with CPAP, biPAP, or ASV, the requested service is likely to be more beneficial for the patient 
than any remaining, available therapies. Therefore, 0424T insertion neurostimulator system for 
central sleep apnea is likely to be more beneficial for treatment of the patients condition than 
any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 29-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient has only partially responded to medical therapy with acid suppressive medication. The LINX Reflux Management System has been shown to be superior to twice-daily proton pump inhibitor (PPI) therapy. Bell and colleagues noted that the LINX Reflux Management System normalized the total number of reflux episodes and acid exposure in 91 and 89 percent of patients, compared with 58 and 75 percent of those treated with twice-daily PPIs. The LINX Reflux Management System has been compared with laparoscopic Nissen fundoplication in several meta-analyses. Clinical control of reflux was comparable after the two procedures. In the study by Ganz and colleagues, the long-term safety and efficacy of the LINX prosthesis was evaluated in a prospective single-group trial of 100 patients with long-standing gastroesophageal reflux disease. At five years after LINX implantation, significantly fewer patients reported moderate or severe heartburn (12 versus 89 percent), moderate or severe regurgitation (1 versus 57 percent), bothersome gas-bloat (8 versus 52 percent), and daily PPI use (15 versus 100 percent). GERD-related quality of life was also better. There is sufficient support for the requested services in this clinical setting. Therefore, the requested LINX procedure is likely to be more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 30-year-old female enrollee has requested reimbursement for knee orthosis provided on 1/04/19. The Health Insurer has denied this request and reported that the device at issue was not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the device at issue in this patients case. The current evidence-based literature supports the use of unloader braces for patients with osteoarthritis of the knee to improve pain and physical function. This patient was diagnosed with right knee osteochondral dissecans defect of the medial femoral condyle and underwent cartilage repair surgery on 11/08/18. A postoperative prefabricated medial unloader brace was prescribed to unload the repaired cartilage defect as she resumed maximal functional activity. Evidence-based guidelines support knee bracing in this clinical setting, and the literature supports use for improved pain and physical function generally. Therefore, the knee orthosis provided on 1/04/19 was medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1 
 
The parent of a 16-year-old female enrollee has requested reimbursement for intra-operative 
electromyography (EMG) monitoring and neuromuscular junction testing during spinal surgery 
including anterior cervical procedures on 2/14/22. The Health Insurer has denied this request 
indicating that the services at issue were investigational for the treatment of the enrollee. The 
physician reviewer found that adolescent idiopathic scoliosis is a condition that causes the spine 
to curve in an S or C shape where the etiology is unknown. Symptoms include tilted, uneven 
shoulders, the prominence of the ribs on one side, an uneven waistline, and one hip being higher 
than the other, and may cause back pain and improper growth. In this case, the patient was 
diagnosed with adolescent idiopathic scoliosis and underwent corrective surgery with thorascopic 
anterior spinal tethering. Intraoperative EMG monitoring and neuromuscular junction testing is a 
form of non-invasive intra-operative monitoring (NIOM) that is safe, well-known to improve 
outcomes,  and  standard  clinical  practice  during  spinal  surgery.  Research  demonstrates  that 
intraoperative EMG is necessary to assess the adequacy of nerve root decompression, detect nerve 
root irritation, and improve the reliability of the placement of pedicle screws during spinal surgery. 
Therefore, intra-operative EMG monitoring and neuromuscular junction testing during spinal 
surgery including anterior cervical procedures on 2/14/22 was likely to have been more beneficial 
for treatment of the patients condition than any available standard therapy.