Persius/hicric huggingface dataset:
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1 
 
A 68-year-old female insured has requested reimbursement for a Guardant360 CDx test provided 
on 1/19/22. The Health Insurer has denied this request indicating that the services at issue were 
considered investigational for evaluation of the insured's metastatic non-small cell lung cancer. 
The physician reviewer found that this patient was recently diagnosed with advanced non-small 
cell  lung  cancer.  The  mutational  landscape  of  non-small  cell  lung  cancer  has  significantly 
expanded in the past few years to encompass gain of function in multiple oncogenes with major 
prognostic and therapeutic implications (Rolfo, et al.). This patients genetic testing was for 
mutually exclusive somatic driver mutations, which is consistent with the standard of care. 
Typically, KRAS, TP53, and BRAF are included in these panels and have been shown to be 
informative in treatment planning. Primary tumor tissue by next-generation sequencing is the 
preferred method for identifying actionable driver mutations. The patients requisition form stated 
that primary tumor sampling was not feasible. For these reasons, the Guardant360 CDx test 
provided on 1/19/22 was likely to be more beneficial for the evaluation of the patients condition 
than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2 
A 68-year-old female insured has requested reimbursement for a Guardant360 CDx test provided 
on 1/19/22. The Health Insurer has denied this request indicating that the services at issue were 
considered investigational for evaluation of the insured's metastatic non-small cell lung cancer. 
The physician reviewer found that the integration of next-generation sequencing (NGS) testing 
into the routine management of stage IV non-small cell lung cancer demonstrates a marked 
increase  in  the  detection  of  therapeutically  targetable  mutations  and  improved  delivery  of 
molecularly guided therapy. The National Comprehensive Cancer Network (NCCN) guidelines 
recommend liquid or plasma NGS if the patient has insufficient tissue from the tumor, or if 
expedited results are necessary. A repeat biopsy can delay care and lead to unnecessary procedures. 
In this case, the provider noted that the patient had insufficient tissue for full NGS testing. 
Therefore, the Guardant360 CDx test provided on 1/19/22 was likely to be more beneficial for the 
evaluation of the patients condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3 
A 68-year-old female insured has requested reimbursement for a Guardant360 CDx test provided 
on 1/19/22. The Health Insurer has denied this request indicating that the services at issue were 
considered investigational for evaluation of the insured's metastatic non-small cell lung cancer. 
The physician reviewer found that this patient was diagnosed with metastatic non-small cell lung 
cancer. The U.S. Food and Drug Administration (FDA) has approved several targeted therapeutic 
agents and inhibitors to support the role for genetic testing in the evaluation of patients with 
metastatic cancer. Per the NCCN, It is recommended at this time that when feasible, testing be  performed  via  a  broad,  panel-based  approach,  most  typically  performed  by  next-generation 
sequencing. Specifically, select tropomyosin receptor kinase (TRK) inhibitors have been FDA-
approved for patients with neurotrophic tyrosine receptor kinase (NTRK) gene fusion-positive 
solid tumors. Moreover, several agents have been FDA-approved for EGFR, ALK, ROS1, BRAF, 
and MET gene mutations or alterations. Next-generation sequencing-based testing including 
Guardant360 CDx has been reported to potentially identify targetable gene mutations or alterations 
with actionable treatment options. Furthermore, the NCCN endorses next-generation sequencing-
based testing such as Guardant360 CDx in the setting of patients with metastatic non-small cell 
lung cancer. As such, the Guardant360 CDx test provided on 1/19/22 was likely to be more 
beneficial for the evaluation of the patients condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1 
 
 
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 patient has ulcerative colitis and was treated with 
Humira (adalimumab). The patient remained symptomatic with abdominal pain, bloody diarrhea, 
and weight loss. The provider sought to potentially switch the patient to a different therapeutic 
agent. The patient underwent bloodwork, including the testing for the presence of antibodies for 
adalimumab. There is a lack of data in well-designed, randomized controlled trials in current peer-
reviewed medical literature that supports this testing as safe and effective. The service at issue was 
not likely to have been superior to standard methods in the evaluation and management of 
ulcerative colitis including up-titrating the patients dose of Humira or switching to an alternative 
agent if there was concern regarding the efficacy of the medication. Therefore, immunoassay for 
analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise 
specified and adalimumab on 8/6/21 was not likely to have been more beneficial for treatment of 
the patient's condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2 
 
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 current medical literature suggests that if there is 
evidence of ongoing inflammation or active disease while on biologic therapy, testing of drug 
antibodies and levels are useful in determining whether or not to make a drug change. In a 
randomized controlled trial, Peyrin-Biroulet and colleagues report that Entyvio is more effective 
than adalimumab in controlling severe ulcerative colitis. In this case, immunoassay or antibody 
testing, not infectious agent otherwise specified, is more beneficial than the standard testing 
including testing for C-reactive protein, or fecal calprotectin, or an elevated platelets count. The 
results may inform the changing of a biologic medication from an anti-tumor necrosis factor (TNF) 
agent, such as Humira, to a different class of biologic medication, such as Entyvio, an alpha-4 
integrin receptor blocker that has been shown to be beneficial in this clinical setting. Therefore, 
immunoassay  for  analyte  other  than  infectious  agent  antibody  or  infectious  agent  antigen; 
quantitative, not otherwise specified was likely to have been more beneficial for treatment of the 
patient's condition than any available standard therapy. However, adalimumab on 8/6/21 was not 
likely to have been more beneficial for treatment of the patient's condition than any available 
standard therapy.
Appeal type: Experimental
Decision: Insurer Denial 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.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary  
The patient is a 64-year-old female with a history of uterine serous carcinoma. The records reflect 
that the patient experienced abnormal vaginal bleeding in April 2022. The patient underwent a 
total  laparoscopic  hysterectomy,  bilateral  salpingo-oophorectomy,  bilateral  pelvic  sentinel 
lymphadenectomy, bilateral common iliac and para-aortic lymph node sampling and cystoscopy. 
The Health Insurer has denied the inpatient services from 8/11/22 through 8/12/22 as not medically 
necessary for the treatment of the patients medical condition. This denial is the subject of this 
appeal and determination. The physician reviewer found that this patient underwent a minimally 
invasive surgical procedure for the treatment of  uterine cancer.  According to  the medical 
documentation, the surgical procedure was uncomplicated and performed without difficulty. There 
is an abundance of evidence in the medical literature that supports the feasibility and safety of 
same-day discharge in patients receiving minimally invasive hysterectomy for both benign and 
cancer  diagnoses.  Therefore,  the  inpatient  services  from  8/11/22  through  8/12/22  were  not 
medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer  
 
The patient is a 53-year-old female with a history of primary open-angle glaucoma. The provider 
states that Vyzulta is the only medication taken by the patient that has been efficacious. 
Therefore, the provider has recommended treatment with Vyzulta 0.024% drops. The Health 
Insurer has denied the requested treatment as not medically necessary for the treatment of the 
patients medical condition. The physician reviewer found that according to the American 
Academy of Ophthalmology (AAO) guidelines, a prostaglandin such as latanoprost, bimatoprost, 
or travoprost is the recommended initial treatment option to lower IOP for patients with primary 
open-angle glaucoma. The AAO guidelines state that, If target IOP is not achieved by one 
medication, then either switching or adding medications should be considered depending on 
whether the individual patient has responded to the first medication. The current medical 
literature has compared the efficacy of available prostaglandin analogue eye drops for the 
treatment  of  patients  with  glaucoma.  A  study  by  Cai  and  colleagues  demonstrated  that 
bimatoprost was more effective in reducing IOP than latanoprost in patients with open-angle 
glaucoma. The authors also concluded that there was no clinically significant difference in the 
IOP-reducing efficacy of travoprost, latanoprost, and tafluprost. In this case, the patient has a 
history of primary open-angle glaucoma. The records provided for review do not demonstrate 
that the patient has tried and failed treatment with bimatoprost. In addition, there is a lack of 
documentation that the patient has a contraindication to treatment with bimatoprost. Overall, 
the medical literature supports that bimatoprost is more efficacious in lowering IOP in patients 
with primary open-angle glaucoma than the requested Vyzulta. Therefore, the requested Vyzulta 
0.024% drops are not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer  
 
The patient is a 64-year-old male with a history of high-risk prostate cancer. The patient was 
evaluated by a radiation oncologist who recommended a course of proton beam therapy. The 
Health Insurer has denied the requested services as not medically necessary for treatment of the 
patients 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.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1 
 
A 51-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing 
performed on 1/18/21. 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  prognostic  gene  expression  profiling  (GEP)  testing  to  differentiate 
melanomas  at  low  versus  high  risk  for  metastasis  should  not  replace  pathologic  staging 
procedures. Moreover, since there is a low probability of metastasis in stage I melanoma and a 
higher proportion of false-positive result, GEP testing should not guide clinical decision making 
in this group. Commercially available GEPs, such as DecisionDx-Melanoma testing, are marketed 
as  being  able  to  classify  cutaneous  melanoma  into  separate  categories  based  on  risk  of 
metastasis.  However,  it  remains  unclear  whether  these  GEP  platforms  provide  clinically 
actionable prognostic information when used in addition to or in comparison with known 
clinicopathologic factors or multivariate nomograms that incorporate patient sex, age, tumor 
location and thickness, ulceration, mitotic rate, lymphovascular invasion, and sentinel lymph 
node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up 
schedules has not been established. Various (mostly retrospective) studies of prognostic GEP 
testing suggest its role as an independent predictor of worse outcome, although not superior to 
Breslow thickness or sentinel lymph node status. It remains unclear whether this GEP profile is 
reliably predictive of outcome across the risk spectrum of melanoma. Prospective validation 
studies are required to more accurately define the clinical utility of molecular testing prior to 
widespread  implementation  of  GEP  for  prognostication  of  cutaneous  melanoma,  and  in 
particular to determine its role in guiding surveillance imaging, sentinel lymph node biopsy, and 
adjuvant treatment decisions. Therefore, DecisionDx-Melanoma testing performed on 1/18/21 
was not likely to have been more beneficial than other available methods of evaluating this 
patient.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2 
 
A 51-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing 
performed on 1/18/21. 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 staging and prognosis of cutaneous melanoma is classically 
determined by applying the system spelled out by Balch. Mitotic index may add to these 
statistics. DecisionDx-Melanoma testing is an assay of 31 genes in an individuals melanoma 
cells. It then places that melanoma into either Class 1 or Class 2. It is not clear how the five-year 
DecisionDx-Melanoma data compares to the ten-year Balch data. Particularly in this case, it is 
not clear how the DecisionDx-Melanoma classification would have added clinical information to  guide further surveillance and treatment. There is a lack of data indicating whether the 
DecisionDx-Melanoma data can be used to make clinical decisions. Therefore, DecisionDx-
Melanoma testing performed on 1/18/21 was not likely to have been more beneficial than 
other available methods of evaluating this patient.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3 
 
A 51-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing 
performed on 1/18/21. The Health Insurer has denied this request and reported that the services 
at issue were investigational for the evaluation of the enrollees medical condition. The physician 
reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous 
melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for 
those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be 
amenable to excision but this suggests a high risk for the development of metastatic disease in 
the future. Such patients may be observed or treated with interferon-alpha. The data on 
DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node 
biopsy. There has also been some lack of consistency between various genes being used as 
biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the 
treatment algorithm beyond standard staging techniques. Therefore, DecisionDx-Melanoma 
testing performed on 1/18/21 was not likely to have been more beneficial than other available 
methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary  
The  patient  is  a  36-year-old  female  with  a  history  of  oromandibular  dystonia,  bilateral 
temporomandibular joint (TMJ) pain, and migraine without aura or without status migranosus, not 
intractable. The provider has recommended botulinum toxin (Botox) injections for oral mandibular 
dystonia to include the temporalis muscle, masseter muscle, and cervical paraspinals. The Health 
Insurer has denied the requested medication as not medically necessary. This denial is the subject 
of this appeal and determination. The physician reviewer found that on review of the available 
records,  this  patient  presents  with  a  history  of  oromandibular  dystonia.  The  provider  has 
recommended injecting Botox into the muscles that are contributing to the patients dystonia. 
Based on the current peer-reviewed medical literature, Botox is considered a first-line treatment 
for the management of patients with oromandibular dystonia. As noted by Deik and colleagues, 
oromandibular dystonia is characterized by involuntary movements involving masticatory, lingual, 
and  pharyngeal  muscles.  Oromandibular  dystonia  can  manifest  as  tongue  protrusion,  jaw 
clenching, jaw opening, and/or jaw deviation. In addition, oromandibular dystonia is oftentimes 
found in combination with dystonia of adjacent body regions, including blepharospasm, cervical 
dystonia, TMJ pain (Hassell and Charles). Botox has been demonstrated to be a safe and effective 
first-line therapy for the treatment of many dystonic syndromes. A number of large safety studies 
have reported data demonstrating the efficacy of Botox without significant long-term side effects. 
Given this support, the requested Botox 200 unit vial is medically necessary for treatment of this 
patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer  
 
The patient is an 11-year-old male with a history of central precocious puberty (CPP). The 
provider has recommended treatment with Lupron Depot-PEDS 30 mg injection. The Health 
Insurer has denied the requested treatment as not medically necessary for treatment of the 
patients medical condition. The physician reviewer found that Gonadotropin-releasing hormone 
(GnRH) agonists such as Lupron Depot-PEDS are used primarily in the treatment of patients with 
CPP. The goals of GnRH therapy for patients with CPP are to halt pubertal progression and 
progressive physical development, including height for age and differences from age- and sex-
matched peers, and to preserve or reclaim adult height potential (Bangalore, et al.). In this case, 
the clinical presentation and course of this patient are consistent with a diagnosis of CPP. The 
patients abnormally advanced bone age predicted adult height of 177.5 cm is significantly below 
the patients MPTH of approximately 187 cm. Therefore, the requested Lupron Depot-PEDS 30 
mg injection is medically necessary for treatment of this patient.