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

Summary Reviewer 1 
 
A 61-year-old female enrollee has requested reimbursement for laboratory testing performed 
on 11/29/19. The Health Insurer has denied this request and reported that the services at issue 
were investigational for the evaluation of the enrollees medical condition. The physician 
reviewer found that if there is insufficient tissue to allow testing for all of EGFR, KRAS, ALK, 
ROS1, BRAF, NTRK1/2/3, MET, and RET, repeat biopsy and/or plasma testing should be done. If 
these are not feasible, treatment is guided by available results and, if unknown, these patients 
are treated as though they do not have driver oncogenes. Cell-free/circulating tumor DNA 
testing should not be used in lieu of a histologic tissue diagnosis. Some laboratories offer 
testing for molecular alterations examining nucleic acids in peripheral circulation, most 
commonly in processed plasma. Studies have demonstrated cell-free tumor DNA testing to 
generally have very high specificity, but significantly compromised sensitivity, with up to 30% 
false-negative rate. Standards for analytical performance characteristics of cell-free tumor DNA 
have not been established, and in contrast to tissue-based testing, no guidelines exist regarding 
the recommended performance characteristics of this type of testing. Cell-free tumor DNA 
testing can identify alterations that are unrelated to a lesion of interest, for example, clonal 
hematopoiesis of indeterminate potential (CHIP). The use of cell-free/circulating tumor DNA 
testing can be considered in specific clinical circumstances; most notably, if a patient is 
medically unfit for invasive tissue sampling, in the initial diagnostic setting, or if following 
pathologic confirmation of a non-small cell lung cancer diagnosis there is insufficient material 
for molecular analysis. Cell-free/circulating tumor DNA should be used only if follow-up tissue-
based analysis is planned for all patients in which an oncogenic driver is not identified. This 
patient appears to have had sufficient tissue for more broad testing if needed, and guidelines 
were similar at the time of testing. Therefore, laboratory testing performed on 11/29/19 was 
not likely to have been more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2 
 
A 61-year-old female enrollee has requested reimbursement for laboratory testing performed on 
11/29/19. The Health Insurer has denied this request and reported that the services at issue were 
investigational for the evaluation of the enrollees medical condition. The physician reviewer 
found that this patient was recently diagnosed with advanced non-small cell lung cancer. Even if 
stage IV or advanced disease is present in non-small lung cancer, therapy targeted to EGFR 
mutations  with  erlotinib  results  in  prolonged  survival  when  compared  with  standard 
chemotherapy regimens.  The mutational landscape of non-small cell lung cancer has significantly 
expanded in the past two to three years to encompass gain of function in multiple oncogenes 
with major prognostic and therapeutic consequences. It is generally accepted that the panel of  mutations that was analyzed in the patient using the Guardant 360 test is for mutually exclusive 
somatic driver mutations. Generally, KRAS, TP53, and BRAF are also included in these panels and 
are informative. The NCCN does not promote brand name products such as Guardant 360 and so 
the specific test is not mentioned but comprehensive mutational testing is mentioned and 
recommended. Therefore, laboratory testing performed on 11/29/19 was likely to have been 
more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3 
 
A 61-year-old female enrollee has requested reimbursement for laboratory testing performed on 
11/29/19. The Health Insurer has denied this request and reported that the services at issue were 
investigational for the evaluation of the enrollees medical condition. The physician reviewer 
found that molecular testing has become a vital part of testing in non-small cell lung cancer and 
can help direct treatment decisions. The most extensive data on molecular testing is on tissue 
samples from either a primary lung tumor or metastatic tumor. Both National Comprehensive 
Cancer Network and American Society of Clinical Oncology guidelines do not recommend the 
regular use of cell-free DNA tests, such as Guardant 360, in lieu of a tissue diagnosis. False 
negative rates can be significant, and there is a lack of published guidelines on the standards for 
analytical performance. In the setting where insufficient tissue can be obtained, circulating tumor 
DNA testing can be considered. However, in this case, tissue was obtained and molecular testing 
was able to be performed.  Therefore, laboratory testing performed on 11/29/19 was not likely 
to have been more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1 
 
A 62-year-old male enrollee has requested authorization and coverage for proton beam therapy. 
The  Health  Insurer  has  denied  this  request  and  reported  that  the  requested  service  is 
investigational for the treatment of the enrollees prostate cancer. The physician reviewer found 
that most current medical literature regarding the treatment of localized prostate cancer is on 
the use of photon-based radiation treatment. The benefits of proton therapy in prostate cancer 
treatment are still controversial due to a lack of high-level evidence showing its relative benefits 
in improving patient quality of life, reducing treatment toxicity, and improving outcomes. Proton 
therapy may potentially reduce the radiation dose to organs at risk and improve radiation dose 
homogeneity. The risk of secondary malignancy is likely lower in patients with prostate cancer 
treated with proton therapy compared to those treated with photon therapy. On the other hand, 
disadvantages  in  using  proton  therapy  include  dose  distribution  and  conformality  and 
uncertainties in the radiobiologic effectiveness in treating patients with prostate cancer. While 
there are no randomized phase III trials comparing the toxicity profile and effectiveness of proton 
therapy versus photon therapy in the treatment of prostate cancer, there are several published 
prospective and retrospective studies with long-term follow-up data showing the safety and 
efficacy of proton therapy in prostate cancer. In this clinical setting though, a combined modality 
using brachytherapy and external beam radiation therapy (EBRT) is likely to provide the patient 
with superior outcomes in terms of biochemical progression-free survival. Therefore, proton 
beam therapy is not likely to be more beneficial for treatment of the patients condition than any 
available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2 
 
A 62-year-old male enrollee has requested authorization and coverage for proton beam therapy. 
The  Health  Insurer  has  denied  this  request  and  reported  that  the  requested  service  is 
investigational for the treatment of the enrollees prostate cancer. The physician reviewer found 
that there is a lack of evidence in current medical literature to suggest that treatment with proton 
therapy is associated with a clinical benefit when compared to standard treatment. There are no 
comparative randomized studies validating the efficacy of proton therapy as compared to 
standard treatment with photons. There is insufficient clinical data to discern whether treatment 
with proton beam radiation offers a clinical benefit compared to conventional radiation therapy 
techniques in the treatment of prostate cancer. In a multi-institutional analysis of 1,850 patients 
with low or intermediate risk prostate cancer that compared groups receiving hypofractionated 
radiation  proton  therapy  and  intensity  modulated  radiation  therapy  (IMRT)  with  photons, 
Vapiwala and colleagues  found no significant difference in gastrointestinal or genitourinary 
toxicities between the two treatments. Further, the authors found no difference in disease 
control between the two modalities. The American Society of Radiation Oncology (ASTRO) states,  Proton beam therapy for primary treatment of prostate cancer should only be performed within 
the context of a prospective clinical trial or registry. ASTRO further notes that the comparative 
efficacy evidence of proton beam therapy with other prostate cancer treatments is still being 
developed, and thus the role of proton beam therapy for localized prostate cancer within the 
current availability of treatment options remains unclear. The National Comprehensive Cancer 
Network (NCCN) guidelines for the treatment of prostate cancer note no clear benefit of proton 
therapy over standard treatment with photons and IMRT. Therefore, proton beam therapy is not 
likely to be more beneficial for treatment of the patients condition than any available standard 
therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3 
 
A 62-year-old male enrollee has requested authorization and coverage for proton beam therapy. 
The  Health  Insurer  has  denied  this  request  and  reported  that  the  requested  service  is 
investigational for the treatment of the enrollees prostate cancer. The physician reviewer found 
that in this clinical setting, the only justified use for proton therapy would be in a clinical trial. 
Standard radiation therapy for prostate cancer is with x-ray IMRT radiation therapy, which has 
been shown to carry no long-term significant side effects. There is a lack of evidence in current 
medical literature showing improvement in terms of local control of the prostate cancer or for a 
survival benefit with the use of proton therapy. The NCCN guidelines note that photon or proton 
EBRT are both effective at achieving highly conformal radiotherapy with acceptable and similar 
biochemical control and long-term side effect profiles. Takeda and colleagues reported a very 
low  rate  of  grade  3  urine  toxicity,  which  is  not  life-threatening  and  does  not  require 
hospitalization, in patients with prostate cancer treated with IMRT and no in stances of grade 4 
toxicity. In a study regarding 15-year outcomes data for 301 patients with prostate cancer treated 
with x-ray IMRT, Weg and colleagues observed grade 3 gastrointestinal toxicity in three patients 
and no instances of grade 4 toxicity. The Radiation Therapy Oncology Group (RTOG) protocol 
notes that the small bowel can tolerate a maximum dose of 50 Gy, which is more than the typical 
dosage of 45 Gy in 2 gray equivalent dosage for EBRT treatment of elective lymph nodes for 
prostate cancer. In this case, the patient reported concern regarding the potential impact of ADT 
due to his history of hypogonadism. In this clinical setting, the NCCN recommends brachytherapy 
and EBRT, noting that ADT is only optional in this setting. Therefore, proton beam therapy is not 
likely to be more beneficial for treatment of the patients condition than any available standard 
therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1 
 
A 30-year-old female enrollee has requested reimbursement for genetic testing on 4/14/22. The 
Health Insurer has denied this request and reported that the service at issue was investigational for 
the evaluation of cystic fibrosis of the enrollees fetus. The physician reviewer found that while the 
Society for Maternal-Fetal Medicine (SMFM) notes that an ultrasound finding of echogenic bowel 
increases the risk of cystic fibrosis in the fetus to by two to three percent, the full gene sequencing 
at issue in this case was not likely to have been more beneficial than standard screening with either 
limited cystic fibrosis variant panels, consisting of 25 to 150 variants, or expanded mutation panels. 
The  American  College  of  Obstetrics  and  Gynecologists  (ACOG)  reports  regarding  carrier 
screening for genetic conditions that analysis of the cystic fibrosis transmembrane conductance 
regulator (CFTR) gene by deoxyribonucleic acid (DNA) sequencing is not appropriate for routine 
carrier screening. The ACOG further notes that this type of testing generally is reserved for patients 
with cystic fibrosis, patients with negative carrier screening results but a family history of cystic 
fibrosis, especially if family test results are not available, males with congenital bilateral absence 
of the vas deferens, or newborns with a positive newborn screening result when mutation testing 
using the standard 23-mutation panel has a negative result. Therefore, genetic testing on 4/14/22 
was not likely to have been more beneficial for evaluation of the patients condition than any 
available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2 
A 30-year-old female enrollee has requested reimbursement for genetic testing on 4/14/22. The 
Health Insurer has denied this request and reported that the service at issue was investigational for 
the evaluation of cystic fibrosis of the enrollees fetus. The physician reviewer found that Hurt and 
colleagues report that isolated echogenic bowel was associated with an increased risk of congenital 
anomalies. Echogenic bowel is diagnosed in 0.2% to 1.4% of second trimester ultrasonographic 
examinations and occurs as a normal variant in the second trimester but has also been associated 
with several pathologic conditions that include cystic fibrosis, chromosomal abnormalities, and in 
utero infection with cytomegalovirus and toxoplasmosis. The diagnosis of fetal echogenic bowel 
in the second trimester has significant implications for prenatal management. The SMFM notes, 
For fetuses with isolated echogenic bowel, we recommend an evaluation for cystic fibrosis and 
fetal cytomegalovirus infection and a third-trimester ultrasound examination for reassessment and 
evaluation of growth. The risk for cystic fibrosis ranges from zero to 13% in the presence of 
isolated echogenic bowel. The finding of dilated loops of bowel in addition to echogenic bowel 
may increase this risk to as high as 17%. Parental cystic fibrosis carrier status should be determined 
if not previously assessed in the current or a previous pregnancy. If both parents are carriers, 
genetic counseling should be undertaken to discuss the risks and benefits of invasive testing for 
fetal genotyping. Racial and ethnic limitations of current cystic fibrosis screening panels should 
be considered when interpreting test results. While the American College of Medical Genetics 
(ACMG) recommends testing for the 23 most common mutations, current medical literature notes 
that there is a lack of coverage for diverse populations by the 23 variants recommended by the 
ACMG. Beauchamp and colleagues report, Modern next generation sequencing (NGS) and 
variant  interpretation  enable  accurate  sequencing-based  cystic  fibrosis  screening.  Limiting  screening to 23 variants does not improve analytical validity, clinical validity, or clinical utility, 
but does fail to detect approximately 30% of at-risk couples. In this clinical setting, the service at 
issue  was  likely  to  have  been  more  beneficial  than  the  standard  screening  of  23  variants 
recommended by the ACMG, which may result in missed cases of cystic fibrosis. Therefore, 
genetic testing on 4/14/22 was likely to have been more beneficial for evaluation of the patients 
condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3 
A 30-year-old female enrollee has requested reimbursement for genetic testing on 4/14/22. The 
Health Insurer has denied this request and reported that the service at issue was investigational for 
the evaluation of cystic fibrosis of the enrollees fetus. The physician reviewer found that the ACOG 
recommends screening for cystic fibrosis carrier states in the general pregnancy population. While 
ACOG does not recommend complete analysis of the CFTR gene in routine screening, it should 
be noted this case does not represent a routine screening event. In this case, the patient had specific 
findings of echogenic bowel that required extended testing for less common variants of cystic 
fibrosis mutation. In this clinical setting, this testing is standard, the most accurate screening tool 
available, and allows for appropriate counseling and medical planning for the pregnancy for the 
best possible outcome. Therefore, genetic testing on 4/14/22 was likely to have been more 
beneficial for evaluation of the patients condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary  
The  patient  is  a  50-year-old  female  who  presented  to  her  provider  on  11/1/22  with  an 
exacerbation of chronic pain in the left shoulder. The patient has requested authorization and 
coverage for prescription tramadol HCL tablet 50 mg. The physician reviewer found that at issue 
is whether prescription tramadol HCL tablet 50 mg is medically necessary for the treatment of 
this patient. The submitted documentation supports the medical necessity of a portion of the 
requested medication. In this case, the patient has chronic pain in her shoulder due to a rotator 
cuff tear. Her previous medications include the antidepressant trazadone and buspirone for the 
treatment  of  anxiety  disorder.  She  has  also  been  on  long-term  treatment  with  high-dose 
ibuprofen, which may be associated with significant gastrointestinal complications including 
ulcers and bleeding. The Centers for Disease Control and Prevention (CDC) guideline on chronic 
pain includes the recommendation to limit opioids for acute pain in most cases to three to seven 
days based on evidence showing an association between use of opioids for acute pain and long-
term use. In this case, given that the patient has tried nonsteroidal anti-inflammatory drugs 
(NSAIDs), antidepressants, anticonvulsants, and acetaminophen, a prescription for seven days of 
tramadol  HCL  tablet  50  mg,  dosed  every  six  hours,  is  medically  indicated.  Therefore,  a 
prescription for seven days of tramadol HCL tablet 50 mg, 30 pills, is medically necessary for the 
treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary  
The patient is a 14-year-old female who presented to her provider on 3/2/23. The records noted a 
diagnosis of absence epilepsy and intractable epilepsy. The physician reviewer found that at issue is 
whether the requested rufinamide 400 mg tablet #180/30 days is medically necessary for the treatment 
of this patient. The submitted documentation supports the medical necessity of the requested 
medication. In this case, the patient has a history of absence epilepsy that has proven to be refractory to 
conventional first-line therapies. The records note that Depakote therapy was associated with 
pancreatitis, which precludes a retrial.  As newer anti-epileptic drugs have emerged, with different 
mechanisms of action, epileptologists are faced with balancing best practices based on available drug 
trials and emerging clinical experience with side effects. Besag and colleagues note that evidence from 
randomized, double-blind, placebo-controlled trials supports the use of rufinamide as adjunct treatment 
for drop seizures for patients with Lennox-Gastaut syndrome (LGS). While the patient in this case does 
not have a diagnosis of LGS, the records document an associated epilepsy which has left her with a poor 
quality of life and limited choices. Panebianco and colleagues report that for people with drug-resistant 
focal epilepsy, rufinamide when used as an add-on treatment is effective in reducing seizure frequency. 
In this clinical setting, while not without its own host of side effects, given that rufinamide may reduce 
this patients seizure burden and provide her with a reasonable quality of life, the requested medication 
is medically indicated. Therefore, rufinamide 400 mg tablet #180/30 days is medically necessary for the 
treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary  
The patient is a 53-year-old female with a history of primary melanoma of the cervix with an 
erythroblastic oncogene B (ERBB)2 V777L mutation. In a letter dated 12/13/22, the provider 
reported that the patient was diagnosed in April 2022. The records noted that the patient had 
undergone initial treatment with four cycles of ipilimumab with nivolumab. 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 the records document that this patient 
presents with a history of primary melanoma of the cervix with an erythroblastic oncogene B 
(ERBB)2 V777L mutation. The patients provider has recommended treatment with Tukysa. Per 
the  National  Comprehensive  Cancer  Network  (NCCN)  guidelines  for  melanoma,  mucosal 
melanoma should be treated as diseases distinct from cutaneous melanoma, with care tailored to 
the individual patient. The U.S. Food and Drug Administration (FDA) has approved Tukysa for 
the treatment of patients with HER2 positive breast cancer or HER2 positive colon cancer, to be 
taken in combination with other agents. However, there is a lack of FDA approved indication or 
support for use of Tukysa for use as monotherapy in the treatment of this patients cancer. Strickler 
and colleagues reported that studies are ongoing to evaluate the efficacy of Tukysa as monotherapy 
and to validate the reported findings from their trial. Overall, there is a lack of data to suggest that 
Tukysa as single agent therapy is safe and effective in this patients clinical setting. All told, the 
requested Tukysa (tucatinib) 150 mg #120/30 days is not medically necessary for treatment of this 
patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer  
The patient is a 32-year-old male. Per the history and physical note dated 5/31/21, he had recurrent 
small bowel obstruction thought to be due to Crohns disease, and presented with increasing 
abdominal pain and distention since the prior evening. The patient has requested reimbursement 
for inpatient services provided from 5/31/21 through 6/02/21. The Health Insurer has denied this 
request and reported that the services at issue were not medically necessary for the treatment of 
this patient. This denial is the subject of this appeal and determination. The physician reviewer 
found that the submitted documentation fails to demonstrate the medical necessity of the services 
at issue. The inpatient level of care was not supported, and the care provided could have been 
provided at the observation level of care. The patient presented with abdominal pain and imaging 
findings consistent with low-grade or partial small bowel obstruction. He had improvement in 
symptoms with  conservative therapy.  Imaging  did  not  show  bowel  ischemia,  and  no  other 
gastrointestinal cause for the inpatient level of care, such as gastrointestinal bleeding, peritonitis, 
toxic megacolon, sepsis, abscess, or other complication was documented. He regained tolerance 
of oral intake without surgical intervention. All of the measures that were undertaken, including 
monitoring, laboratory testing, specialist consultations, colonoscopy, and advancement of diet, 
could have been performed without the inpatient level of care, at the observation level of care. 
Therefore, inpatient services provided from 5/31/21 through 6/02/21 were not medically necessary 
for the treatment of this patient.