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

Summary Reviewer 

The parent of a 10-year-old male has requested authorization and coverage for Nutropin AQ Nuspin 20. 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 short stature is a known feature of children with congenital adrenal hyperplasia. The short stature is due to advanced bone age due to androgens from under treatment and can also be due to overtreatment from glucocorticoids. Therefore, a right balance of glucocorticoids is recommended to achieve optimal adult height. This patient had advanced bone age that has been stable after initiation of treatment with Cortef. His estimated adult height is 174 cm, based on a height of 152.2 cm on 2/08/19 and advanced bone age of 13 years six months. This is a normal adult height prediction and does not justify treatment with growth hormone therapy. This patient has good linear growth as indicated on his growth chart. Neither the patients current height nor the estimated adult height is 2.25 standard deviations below the mean, and this patient does not have idiopathic short stature. The current medical evidence does not support the requested medication in this clinical setting. Therefore, Nutropin AQ Nuspin 20 is not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1 
 
A 49-year-old female enrollee has requested reimbursement for laboratory services performed 
at Diagnostic Solutions Laboratory on 3/29/22. The Health Insurer has denied this request and 
reported that the services at issue were investigational for the evaluation of the enrollee. The 
physician reviewer found that there is a lack of evidence-based guidelines and well-constructed 
randomized  clinical  studies  to  support  the  use  of  a  gastrointestinal  map  panel.  Mao  and 
colleagues report that fecal calprotectin (FC) is a relatively new marker of intestinal inflammation. 
Fecal calprotectin correlates to some degree with endoscopic findings and serum markers of 
inflammation  in  inflammatory  bowel  disease.  Kopylov  and  colleagues  note  that  fecal 
inflammatory biomarkers such as calprotectin and lactoferrin are direct products of bowel 
inflammation and provide an accurate and noninvasive diagnostic and monitoring modality for 
Crohn's disease and ulcerative colitis.  However, the appropriateness of this test in the diagnosis 
and  management  of  patients  without  known  inflammatory  bowel  disease  has  not  been 
demonstrated. In this case, polymerase chain reaction testing for stool pathogens showed 
Clostridioides difficile toxin. The records did not document chronic or persistent diarrhea prior to 
the performance of the services at issue. Guidelines for the management of Clostridioides difficile 
do not recommend a full panel of gastrointestinal pathogen testing with polymerase chain 
reaction for evaluation of the documented symptoms and the service at issue was not consistent 
with initial recommended workups for abdominal pain, constipation, or bloating. The service at 
issue has not been shown to be superior to the use of evidence-based guidelines for diagnosis 
and clinical management of irritable bowel syndrome. Therefore, laboratory services performed 
at Diagnostic Solutions Laboratory on 3/29/22 were not likely to have been more beneficial for 
evaluation of the patients condition than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 56-year-old male enrollee has requested authorization and coverage for proton treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees tumor of the hypopharynx. The physician reviewer found that there is limited, evidence based, peer reviewed literature on the effectiveness of proton therapy over other forms of treatment in this clinical setting.  A 2014 review article by Holliday and Frank cited only one study (of 29 patients) of proton therapy for oropharyngeal cancer, and none are cited for hypopharyngeal cancers. Data on proton therapy for hypopharyngeal cancers are scant.  Likewise, there is scant data which compares outcomes with proton therapy versus intensity modulated radiation therapy (IMRT). While preliminary dosimetric data suggests that proton therapy may be better at sparing pharyngeal constrictor muscles spinal cord, parotid glands, larynx, and brainstem whether dose reduction to any of these structures (beyond what IMRT can achieve) results in any benefit in clinical outcome is unknown. There is not enough studies that definitively show that proton therapy (in general) affords benefit over conventional radiation therapy.  The most recent National Comprehensive Cancer Network guidelines (v2.2016) do not address proton therapy for pharyngeal cancers and explicitly state that the role of proton therapy is being investigated for ethmoid and maxillary sinus cancers. At this time, further clinical data through prospective clinical trials are needed regarding cases in which the target is the primary volume located near critical structures. For this patient, there is no documentation that IMRT would result in an unacceptable plan. Currently, there are insufficient data to recommend proton treatment for routine head and neck radiation therapy outside of clinical trials. In summary, proton treatment is not likely to be superior to IMRT. Therefore, 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.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 56-year-old male enrollee has requested reimbursement for service code 84999, OncotypeDX prostate cancer assay completed on 6/6/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer.The physician reviewer found that the medical evidence supports that the OncotypeDX assay can be used to better stratify such patients with localized disease. Once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features such as the grade of tumor and prostate-specific antigen level. This helps guide the most appropriate therapy for patients taking into account their age and comorbidities because many patients will not require therapy (i.e., surgery or radiation) and may be followed closely instead. Current biomarkers are inadequate for risk stratification and better prognostic biomarkers are needed. The Prostate OncotypeDX is a gene expression analysis that targets genes in the biopsy specimen that generates a genomic prostate score (GPS). A validation study was presented at the American Urological Association meeting in 2013 involving 395 patients (Cooperberg, et al). The GPS identified patients that had very low risk disease that could be followed rather than referred for surgery. The current prognostic features are inadequate to make firm recommendations regarding active surveillance to patients. The National Comprehensive Cancer Network (NCCN) guidelines also suggest the OncotypeDX test to better stratify such patients with localized disease. In sum, service code 84999, OncotypeDX prostate cancer assay completed on 6/6/16 was likely to have been more efficacious than the other treatment options for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for the 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 

A 54-year-old female enrollee has requested authorization and coverage for cingulotomy. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollee, who has been diagnosed with metastatic renal cell carcinoma. The physician reviewer found that the submitted records fail to demonstrate the superior efficacy of the requested services. The patient has widespread metastatic renal cell carcinoma. Her prior treatment has included surgery, radiation therapy and chemotherapy. She has pain for which she is using large doses of MS Contin and oxycodone. The records noted widespread, non-localizing pain. The clinical notes do not document if she is a candidate for a spinal cord stimulator to treat her pain. There is a lack of large, randomized, prospective, controlled studies demonstrating the long-term efficacy and safety of cingulotomy and laser interstitial thermal therapy for chronic diffuse pain. At this time, further studies are warranted to establish the efficacy of the requested services in this clinical setting. Therefore, the requested cingulotomy is not likely to be superior over other available treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

I have determined that the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Insurers denial should be upheld. The physician reviewer found that the patient is a 53-year-old male who presented for a course of treatment on 4/25/18 for the diagnosis of lumbosacral intervertebral disc displacement. It was noted that the patients lower back pain began in 2012 after a hot yoga class.  Prior treatment reportedly included facet joint injections. On 4/26/18, the patient began a course of mechanized spinal distraction therapy. He has requested reimbursement for mechanized spinal distraction therapy for low back pain provided on 4/26/18, 4/30/18, 5/01/18, 5/02/18, 5/03/18, 5/07/18, 5/08/18, 5/09/18, 5/10/18, 5/14/18, 5/15/18, 5/16/18, 5/17/18, 5/21/18, 5/22/18, 5/23/18, 5/24/18, 5/29/18, 5/30/18 and 6/04/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of this patient.

There is a lack of support for the services at issue in this clinical setting. The records document a history of low back pain. The patients prior treatment included facet joint injections. Additionally, he has tried acupuncture and physical therapy. The medical literature has not demonstrated that mechanized spinal distraction therapy is superior over standard modalities for the treatment of this patient. Thus, mechanized spinal distraction therapy for low back pain provided on 4/26/18, 4/30/18, 5/01/18, 5/02/18, 5/03/18, 5/07/18, 5/08/18, 5/09/18, 5/10/18, 5/14/18, 5/15/18, 5/16/18, 5/17/18, 5/21/18, 5/22/18, 5/23/18, 5/24/18, 5/29/18, 5/30/18 and 6/04/18 was not likely to have been more effective 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.
Appeal type: Medical Necessity
Decision: Upheld

Summary  
The patient is a 34-year-old female who presented to the emergency department from urgent care 
via ambulance with complaints of right lower back pain radiating to the left lower back with 
headache,  dizziness,  vomiting,  and  fever.  The  patient  has  requested  reimbursement  for  the 
inpatient hospital stay from 6/26/22 through 6/29/22. The Health Insurer has denied the services 
at issue as not medically necessary. This denial is the subject of this appeal and determination. The 
physician reviewer found that inpatient care is indicated when a patients signs, symptoms, and 
general medical condition can only be managed safely in an acute inpatient setting, when the 
patient requires diagnostic studies in an inpatient setting, or if there is another clinical indication, 
such as sepsis, for the patient to remain in the acute inpatient setting.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2
A 61-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/19/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented for a breast examination.  The physician reviewer found that the medical literature supports breast tomosynthesis in this clinical setting.  Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues state that integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. Thus, the literature supports the use of digital breast tomosynthesis over conventional mammogram due to improved cancer detection rate.  In sum, digital breast tomosynthesis performed on 7/19/16 was likely to have been superior to other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to 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: Upheld

Summary Reviewer 1

A 24-year-old male enrollee has requested reimbursement for services provided from 5/10/15 through 8/05/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the superior efficacy of the services at issue.  There is a lack of convincing evidence of superior treatment of wilderness therapy to standard accepted therapies.  Bettmann and colleagues reported that wilderness therapy research is significantly lacking in controlled studies. Widmer and colleagues reported that although some studies report benefits of wilderness therapy, caution should be exercised in the interpretation of these results.  There is a lack of studies proving that wilderness therapy is more beneficial for treatment of social pragmatic communication disorder and unspecified neurodevelopmental disorder. Therefore, the services provided from 5/10/15 through 8/05/15 were 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.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 51-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 9/29/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the Guardant360 test is a liquid biopsy that analyzes patient plasma for mutations in a panel of 70 genes. In most instances of visceral disease or lymph node involvement, testing can be performed on the excised tissue, but in certain cases, this tumor tissue is inaccessible. For example, for bone metastases, the decalcification process makes the material unsuitable for gene sequencing. Thus, liquid biopsy is specifically mentioned in the National Comprehensive Cancer Network (NCCN) guidelines in these instances. Mutational testing by this method or by direct tumor sequencing offers a rational selection of the next regimen. When Guardant360 testing was ordered, the patient had a mixed response to fulvestrant and alpelisib. Whereas most tumor lesions were stable, one liver lesion had increased in size. The oncologist requested a Guardant360 serum analysis of mutations. This was an effort to verify the HER2-point mutation that was found previously by Foundation One analysis of the liver specimen and to use HER2-directed therapy. Finding this mutation in the plasma just indicates that one of the metastatic sites has the mutation. The test does not verify whether the liver lesion is the source of the mutation. Since this liver lesion in segment 2 of the liver was the area of progression, one would need mutational testing done on it to help direct therapy. Therefore, Guardant360 testing performed on 9/29/20 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 56-year-old male enrollee has requested reimbursement for positron emission tomography (PET) scan performed on 1/19/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found following the diagnosis and initial treatment for prostate cancer, it is conventional to obtain sequential prostate-specific antigen levels every six to twelve months for five years.  With a failure of the prostate-specific antigen levels to fall to undetectable levels, or with progressive increases in prostate-specific antigen levels, imaging or biopsies may be indicated.  These additional studies will generally dictate future treatment options.  However, routine technetium bone scans will occasionally not be diagnostic and scanning with PET scans has been developed as a second line scanning technique.  In this patients case, the routine bone scan was not diagnostic.  The results of the PET scan performed on 1/19/16 were likely to have a major impact on the choice of treatment.  Thus, the PET scan performed on 1/19/16 was likely to have been of greater benefit than other methods of evaluation.  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.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 39-year-old female enrollee has requested reimbursement for Prometheus Anser ADA testing performed on 1/27/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. In this case, the Anser ADA testing was ordered to determine the etiology for possible loss of response to Humira and to direct the management of the patients Crohns disease. The test revealed antibodies and that the drug was present. However, the use of Anser ADA has not been clinically proven to improve patient clinical outcomes, and has not definitively demonstrated clinical utility. The effectiveness of Anser ADA compared with conventional courses of action remains unproven. Patients being treated with adalimumab may experience loss of response. However, the appropriate method for determination of the cause for loss of response is not clear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature (Karmiris, et al; Imaeda, et al; Lichtenstein, et al). These small studies at best demonstrated correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect. The study by Karmiris and colleagues found no direct relationship between trough serum adalimumab concentration or anti-adalimumab antibody and short-term treatment efficacy. Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. Clinical guidelines for management of inflammatory bowel disease do not recommend testing for anti-drug antibody during clinical management (Lichtenstein, et al). A review article by Yanai and Hanauer reported that prospective controlled trials are direly needed to investigate the optimal tailored management in individual patients who lose response. In sum, there is a lack of sufficient evidence in the peer-reviewed literature to establish the testing at issue as likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

An 80-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire airway stimulation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. This patient has already failed CPAP therapy and is not an optimal candidate for oral appliance therapy due to the severity of his obstructive sleep apnea. Multiple studies have demonstrated that hypoglossal nerve stimulation or Inspire airway stimulation improves health for people with obstructive sleep apnea with clinically significant decreases in observed mean apnea-hypopnea index and improvements in quality of life. The American Academy of Otolaryngology-Head and Neck Surgery considers aupper airway stimulation via the hypoglossal nerve for the treatment of adult obstructive sleep apnea syndrome to be a safe and effective second-line treatment of moderate to severe obstructive sleep apnea in patients who are intolerant or unable to achieve benefit with positive pressure therapy.a All told, hypoglossal nerve stimulation or Inspire airway stimulation is likely to be more beneficial than any available standard therapy.