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

Summary Reviewer 3

A 54-year-old male enrollee has requested authorization and coverage for Gilotrif (afatinib dimaleate tablet 40 mg).  The Health Insurer indicates that the requested medication is investigational for the treatment of the enrollees medical condition. Therefore, the Health Insurer has denied coverage for the requested medication.
At issue is whether the requested medication is likely to be more beneficial for treatment of the enrollees condition than any available standard therapy. The physician reviewer found that Afatinib is an inhibitor of EGFR. This medication is of benefit in non-small cell lung cancers, particularly adenocarcinoma, wherein there exist certain mutations of the EGFR gene. Although such mutations are rare in squamous carcinoma, they do exist, and there has been some responsiveness in squamous cell cancer with specific mutations. However, there is no real data showing reliable benefit with afatinib in patients with the very rare mutations documented in this patient. Therefore, Gilotrif (afatinib dimaleate tablet 40 mg) is not likely to be more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 53-year-old male enrollee has requested authorization and coverage for Inspire upper airway stimulation system.  The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition. The physician reviewer found obstructive sleep apnea is an increasingly prevalent clinical problem with significant effects on both personal and public health.  CPAP has demonstrated excellent efficacy and low morbidity.  Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology.  There is sufficient support for the requested device in this clinical setting.  In this patient who is status post multiple procedures for sleep apnea, and who cannot tolerate CPAP or an oral appliance, implantation with a hypoglossal nerve stimulator is appropriate.  All told, the requested Inspire upper airway stimulation system is likely to be more effective than other treatment options.  Based upon the information set forth above, the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 27-year-old female with a history of vitiligo affecting the facial skin. The patient has been treated with Xtrac (excimer) laser therapy. The patient has requested reimbursement for dermatology services provided from 6/10/15 through 7/29/15. The Health Insurer has denied this request as not medically necessary.  Review of the submitted documentation and relevant literature demonstrates the medical necessity for the services at issue. According to the documentation submitted for review, the patient has been treated with Xtrac laser therapy for treatment of vitiligo affecting the facial skin. Vitiligo is an autoimmune disorder resulting in destruction of melanocytes, the pigment generating cells, in the skin. Use of the Xtrac (excimer) laser is a U.S. Food and Drug Administration (FDA) approved therapy for the treatment of vitiligo. In addition, treatment of vitiligo is not considered cosmetic, as therapy is aimed at encouraging repigmentation in areas where melanocytes have been destroyed by the autoimmune process. Therefore, dermatology services provided from 6/10/15 through 7/29/15 were medically indicated for this patient.

For the reasons provided, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 49-year-old female enrollee has requested reimbursement for Tempus xT gene panel performed on 3/16/20.  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 Tempus is one of a number of multigene and molecular features assay of an individuals cancer cells. The hope is that it will indicate a specific drug that can target a mutation or molecular target. However, thus far, there is no clear data to indicate that using the assay in that way can reliably yield a treatment with significant clinical benefit. A randomized study by Le Tourneau and colleagues did not find that picking a treatment based on such an assay is superior to that using the oncologists judgment. Several reports indicate that the benefit from using such an assay is rare and unlikely. Therefore, the Tempus xT gene panel performed on 3/16/20 was not likely to have been more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 58-year-old male enrollee has requested reimbursement for test for allergy or toxicity (immunoglobulin G (IgG) food sensitivity testing) performed on 3/14/18. 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 there is a lack of high-quality clinical literature supporting the use of IgG food allergy testing for the investigation of gastrointestinal symptoms or irritable bowel syndrome. Notably, a number of national and international medical societies have expressed recommendations against the use of this testing and concern about its ongoing use for this indication. The American Academy of Allergy, Asthma and Immunology and American College of Allergy, Asthma and Immunology practice guidelines state that IgG and IgG subclass antibody tests for food allergy do not have clinical relevance, are not validated, lack sufficient quality control, and should not be performed. The American Academy of Allergy, Asthma and Immunology guideline for management of adverse reactions to foods states that measurement of specific IgG antibodies to foods is unproven as a diagnostic tool. Thus, IgG food sensitivity testing performed on 3/14/18 was not likely to be 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.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 




The parent of a 10-year-old male enrollee has requested reimbursement for neuropsychological testing provided on 9/6/16, 9/8/16, 9/16/16, and 9/29/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees cognitive abilities The physician reviewer found that there is a lack of support in the medical literature for the services at issue in this clinical setting. The American Academy of Pediatrics (AAP) recommend obtaining information from the teachers and parents of the student as part of the evaluation for ADHD.  The evaluation should also include the Diagnostic and Statistical Manual of Mental Disorders criteria for ADHD. The documentation provided does not indicate that these recommended assessments were performed in this case. Assessment systems such as the Vanderbilt, Connors or the Behavior Assessment System for Children (BASC), are also recommended evaluation tests for ADHD. There is a lack of medical evidence to support neuropsychological testing in this clinical setting. The primary concern, in this patients case was academic functioning and possible ADHD. As such, the services at issue are not supported by the medical literature. Therefore, the neuropsychological testing provided on 9/6/16, 9/8/16, 9/16/16, and 9/29/16 were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 62-year-old male enrollee has requested reimbursement for laboratory testing (Fibrotest-Actitest) performed on 8/14/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting.  Fibrotest and Actitest permit the noninvasive evaluation of patients with hepatitis C or hepatitis B for the presence of liver fibrosis and liver inflammation, respectively.  Fibrotest and Actitest scores, on a scale of 0.0 to 1.0, are assigned a Metavir scale indicating the level of fibrosis or inflammation present.  Several prospective studies have confirmed the overall accuracy of the Fibrotest in discriminating advanced from non-advanced fibrosis.  All told, laboratory testing performed on 8/14/15 was likely to have been superior over 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 29-year-old female enrollee has requested reimbursement for the Anser ADA test provided on 10/13/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis.  The physician reviewer found that monitoring patients on adalimumab with measurement of adalimumab levels and antibodies continues to be an area of intense investigation. In general, adalimumab levels correlate inversely with disease activity. However, the target level of adalimumab necessary to achieve clinical benefit remains unknown. There is a lack of controlled data which have identified the optimal drug level and the issue remains speculative. Although appealing this algorithmic approach has not been validated using prospectively controlled data. Consistent with these findings, the Anser ADA test provided on 10/13/14 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined 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: Overturned

Summary Reviewer 


A 47-year-old female enrollee has requested authorization and coverage for Lyrica. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees peripheral neuropathy. The physician reviewer found the submitted documentation establishes the medical necessity of the requested medication. This patient presents with neuropathy with neuropathic pain. It is well-established that diabetic neuropathy is a model for many types of neuropathy. Nearly half of all neuropathies have no clear cause, but for the most part, the pain noted with neuropathy has a final common pathway, and similar response to treatment. There are a number of studies in the medical literature showing Lyrica is effective in a variety of neuropathic pain. Furthermore, Lyrica is widely prescribed by providers for neuropathic pain outside of diabetic peripheral neuropathy. In this case, the patient has tried and failed standard therapies including gabapentin and amitriptyline and has found Lyrica to be the most effective without side effects. As such, Lyrica is medically necessary for treatment of this patients painful peripheral neuropathy. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 51-year-old female enrollee has requested reimbursement for Avastin provided on 12/16/14, 1/6/15, 1/27/15, 2/17/15, and 3/10/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees recurrent metastatic breast cancer.  The physician reviewer found the patient was diagnosed with metastatic triple negative breast cancer in September 2014. The patient started treatment with Avastin, carboplatin, and Taxol. A scan done in December 2014 and compared to September 2014 revealed a marked response to therapy. The patient had significant side effects with the cytotoxic components of this regimen, which prompted discussion to proceed with single agent Avastin. There are adequate studies demonstrating the clinical efficacy of Avastin in this clinical setting. Further, this patients aggressive form of breast cancer demonstrated a very good response to therapy. All told, the Avastin provided on 12/16/14, 1/6/15, 1/27/15, 2/17/15, and 3/10/15 was medically necessary for treatment of this patients medical condition.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 54-year-old female enrollee has requested authorization and coverage for surgery to treat her heart rhythm. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee, who has a history of paroxysmal (AF) atrial fibrillation. The physician reviewer found that the patient has a history of persistent AF and has required cardioversions. She is now on antiarrhythmic drug therapy with dronedarone.  According to the guidelines endorsed by the American College of Cardiology, American Heart Association and the Heart Rhythm Society, catheter ablation of atrial fibrillation in this patient would be recommended, AF catheter ablation is useful for symptomatic paroxysmal AF refractory or intolerant to at least one class I or III antiarrhythmic medication when a rhythm-control strategy is desired. In this patients case, the provider reported that the patient has symptomatic paroxysmal AF despite antiarrhythmic drug therapy. Thus, catheter ablation of atrial fibrillation was offered. In sum, the requested surgery to treat her heart rhythm is likely to be more effective than the standard options available for the treatment of this patients medical condition. Therefore, for the reasons stated above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3
The parent of a 17-year-old male enrollee has requested reimbursement for wilderness therapy program provided from 7/11/16 through 9/21/16 and from 11/3/16 through 12/27/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees behavioral health condition. The physician reviewer found that the documentation provided does not support the superior efficacy of the wilderness therapy program over the available standard forms of treatment in this clinical setting. There is a lack of robust, evidence based studies to support wilderness therapy programs are superior over the standard, evidence based treatment options to address this patients diagnoses. The progress notes do not indicate that the patient was treated on any regular intervals by a psychiatrist during his stay at the wilderness program.  Key treatment goals described by the treatment program appeared vague in nature.  Treatment interventions were listed as individual and group therapy as well as various mindfulness activities and clinical evaluation. There were no treatment goals for interventions that could not have occurred in a community based treatment setting. As such, the wilderness therapy program provided from 7/11/16 through 9/21/16 and from 11/3/16 through 12/27/16 was not likely to have been superior over the standard treatment options available for treating this patient. 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: Overturned

Summary Reviewer 3

A 60-year-old male enrollee has requested reimbursement for repair of anorectal fistula provided on 10/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees anal fistula.  The physician reviewer found that the American Society of Colon and Rectal Surgeons (ASCRS) has published practice parameters for the management of perianal abscess and fistula-in-ano (Steele, et al). The treatment recommendations for complex fistulas include seton, fistulotomy, fibrin glue, plug, endorectal advancement flap, and ligation of intersphincteric fistula tract. Placement of a seton with or without fistulotomy has a strong recommendation based on moderate evidence. The use of the Gore Bio-A fistula plug has been recently evaluated in recent studies. In the prospective study by Herold and colleagues, 60 patients with transsphincteric fistulas underwent plug placement and the healing rate at one year was 52%. Most importantly, there was no effect on incontinence which can be a side effect of other procedures performed for management of anal fistula such as cutting seton, fistulotomy, or endorectal advancement flap. In the study by Stamos and colleagues, 93 patients with transsphincteric fistulas were treated at 11 colon and rectal centers. The healing rates at six and 12 months were 41% and 49%, respectively. The authors concluded that implantation of a fistula plug is reasonably efficacious treatment for anal fistula, especially given its simplicity and low morbidity. Given that the support in the peer-reviewed literature and ASCRS practice parameters, the anorectal fistula provided on 10/23/15 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. 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.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1 
 
A 65-year-old male enrollee has requested reimbursement for polymerase chain reaction (PCR) 
testing on 8/10/21. The Health Insurer has denied this request and reported that the service at 
issue was investigational for the evaluation of the enrollees severe diarrhea. The physician 
reviewer found that The Infectious Diseases Society of America guidelines for acute diarrhea note 
that  certain  pathogens  that  can  cause  protracted  diarrhea,  and  cannot  be  detected  with 
commonly used tests, may be found with nucleic acid amplification tests (NAATs). The American 
College of Gastroenterology guidelines for the management of acute diarrhea states, Traditional 
methods  of  diagnosis  (bacterial  culture,  microscopy  with  and  without  special  stains  and 
immunofluorescence, and antigen testing) fail to reveal the etiology of the majority of cases of 
acute diarrheal infection. If available, the use of U.S. Food and Drug Administration (FDA) 
approved culture-independent methods of diagnosis can be recommended at least as an adjunct 
to traditional methods. PCR testing may be far more sensitive in clinical testing for the detection 
of certain pathogens due to a high sensitivity. Beal and colleagues note that a gastrointestinal 
PCR  test  may  more  accurately  diagnose  patients  with  diarrhea,  resulting  in  improved 
management. In this case, the patient had persistent diarrhea for weeks. A provider letter dated 
9/20/22 reported that the testing at issue showed enteropathogenic Escherichia coli (E.coli).  In 
this clinical setting, initial gastrointestinal PCR pathogen panel testing was likely to have been 
more beneficial for evaluation of the patients diarrhea than any available standard therapy. 
Therefore, PCR testing on 8/10/21 was likely to have been more beneficial for the evaluation of 
the patients condition than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3 
 
The parent of a 16-year-old male enrollee has requested reimbursement for immunoassay for 
analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise 
specified and adalimumab on 8/6/21. The Health Insurer has denied this request indicating that the 
service and medication at issue were investigational for the treatment of the enrollees ulcerative 
colitis. The physician reviewer found that the use of testing for Humira drug levels and anti-Humira 
antibody levels is supported by guidelines in this clinical setting. In this case, the patient had 
symptoms of active ulcerative colitis despite being on Humira. The American Gastroenterological 
Association (AGA) guideline on therapeutic drug monitoring in inflammatory bowel disease 
suggests reactive therapeutic drug monitoring to guide treatment changes in adults with active 
inflammatory bowel disease treated with anti-TNF agents. The guideline suggests target trough 
concentrations of 7.5 mg/mL for adalimumab. Drug concentration and anti-drug antibody levels 
should be checked if there is a loss of response to an anti-TNF medication such as Humira, 
allowing for a subsequent change in management including a switch within drug classes, assessing 
for inflammation, or increasing the dose. The AGA guidelines for the management of ulcerative 
colitis also recommend drug level testing, noting that the patient with nonresponse or loss of 
response to therapy should be assessed with therapeutic drug monitoring to identify the reason for 
lack of response and whether to optimize the existing therapy or to select an alternate therapy. In 
this case, given that the patients symptoms that were consistent with active or uncontrolled 
ulcerative colitis, he was at risk for complications from ulcerative colitis such as toxic megacolon, 
hospitalization, need for surgery, or colonic dysplasia leading to colorectal cancer. In this clinical 
setting,  testing  for  Humira  drug  level  and  anti-Humira  antibody  level  was  appropriate  per 
guidelines for the assessment of whether the patients Humira dose should be increased or changed 
to an alternative therapy. As the guidelines do not recommend any alternative therapy, the testing 
at issue was likely to have been more beneficial than a standard approach of changing Humira to 
another therapy, which could be ineffective and result in entirely uncontrolled disease and severe 
complications such as hospitalization, surgery, and toxic megacolon. Therefore, immunoassay for 
analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise 
specified, and adalimumab on 8/6/21 was likely to have been more beneficial for treatment of the 
patient's condition than any available standard therapy.