Persius/hicric huggingface dataset:
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Urinary Retention 
 Treatment: Inpatient Admission 

The insurer denied the inpatient admission. The denial was reversed. 

This is a male patient with a medical history of hypertension, vitamin D deficiency, and osteoarthritis. He presented to the hospital for a total arthroplasty of his left knee. Post-operative the patient developed urinary retention requiring straight catheterization. Three trial void tests were performed in 24 hours; the patient failed all three. Urology consulted on the patient. A bladder scan was performed that revealed 526 milliliters. A Foley catheter was placed releasing 500 milliliters of urine. He was started on Flomax. It was recommended the patient be discharged with the indwelling Foley catheter in place for three to four days. He was discharged with the foley with outpatient instruction to follow up with the urologist. 

Based on the review of the medical records, this patient was experiencing post-surgical complication, specifically urinary retention, which required ongoing management. This patient's urinary retention was unforeseen and did not improve with standard treatment that could be provided at observational level of care. This patient failed on multiple void trials, required straight catheterization and ultimately a Foley placement that was to be continued for additional days after discharge. The patient's acute urinary retention was new to the patient, and required Urology consult and evaluation. The patient was prescribed several medications, and needed additional testing, such as bladder scans. This patient's condition required several days to treat, monitor, and to improve. 

This patient's hospital care was medically necessary based on the MCG Health 24th Edition guidelines on urinary complications, especially for postoperative patient. The patient had postoperative urinary retention that required drainage. And consistent with MCG guidelines on hospital care, this patient received straight in-out catheterization, and also a catheter placement due to this patient's significant urinary retention noted on the bladder scan. This patient's acute and persistent urinary retention after his surgery was complex and required the level of care at the inpatient status. 

The health care plan did not act reasonably with sound medical judgment and in the best interest of the patient. 

The carrier's denial of coverage for the acute inpatient hospital admission is reversed.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Syncope
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The denial is overturned. 

The patient is a male with a past medical history significant for HTN (hypertension), diabetes mellitus, prostate cancer, s/p RT (status post radiation therapy), who presented to the ER after a postprandial syncope episode, with loss of consciousness and was observed slumped over in a chair for several minutes, with loss of urine prior to returning to baseline. There was also a report of palpitations the night prior, which had resolved. The patient was hypertensive on arrival, with BP (blood pressure) in 170-190 systolic range. He complained of headache, and was noted to have episodes of confusion. ECG revealed normal sinus rhythm at 89 with prolonged QT, non-specific T-wave changes. He was diagnosed with hypertensive emergency and admitted for further management. CT of the brain revealed no acute bleeding or CVA (cerebrovascular accident). Cardiac enzymes were negative. 

The patient was seen in consultation by neurology and cardiology. He was given IV hydralazine and his PO (by mouth) medications were continued with increase in losartan dose and addition of amlodipine and metoprolol. Echocardiogram was obtained and was unremarkable. His BP improved with medical therapy and he was discharged home with a plan for outpatient follow-up.

Yes, the Inpatient Admission is "medically necessary".

The patient presented with syncope episodes and on admission was found to have severe hypertension, with headache and confusion and ECG abnormalities, consistent with hypertensive emergency. Given the presentation, uncontrolled hypertension, as well as clinical suspicion for an acute cardiac or neurological cause of syncope, it would be consistent with the current standard of care that this patient be managed in an inpatient setting, and therefore the requested inpatient admission was medically appropriate in this clinical setting.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic inflammatory demyelinating polyneuropathy (CIDP) and immunoglobulin A (IgA) kappa associated neuropathy.  
Treatment: J9312 - Injection, rituximab, 10mg
The insurer denied the J9312 - Injection, rituximab, 10mg. 
The denial is upheld. 

The patient is a male with chronic inflammatory demyelinating polyneuropathy (CIDP) and immunoglobulin A (IgA) kappa associated neuropathy. He has been treated with intravenous immunoglobulin (IVIG) and plasma exchange without improvement. 

No, the proposed treatment with rituximab was not medically necessary. 

There are no high-quality clinical trials or standard of care guidelines to support the use of Rituximab for the treatment of CIDP. All studies to date are retrospective or case series. The efficacy of Rituximab for CIDP remains undetermined. Similarly, there are no high-quality clinical trials or standard of care guidelines to support the use of rituximab for the treatment of IgA kappa associated neuropathy.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal Pain.

Treatment: Inpatient admission.

The insurer denied the inpatient admission.

The denial was upheld. 

This is a male patient who presented to the Emergency Room with complaints of sudden onset abdominal/chest pain. The patient was afebrile and was hemodynamically stable. At the time of admission, the patient had mild tenderness with no abdominal rebound or guarding. There was no leukocytosis. The patient's computed tomography angiography (CTA) scan showed a soft tissue density adjacent to the mid superior mesenteric artery (SMA) but was negative for aortic disease. The patient's duplex study did not show abnormalities.  Rheumatology, Vascular Surgery, and Gastroenterology were consulted. It was suggested that the patient did not have a vasculitis and surgical intervention was not recommended. The gastroenterologist advised treatment with Pepcid. The patient was discharged with outpatient follow up. 

According to MCG guidelines for undiagnosed abdominal pain (M-05), clinical indications for admission include hemodynamic instability, peritoneal signs, or the need for a procedure that cannot be performed on an ambulatory basis. In this case, the patient did not have these clinical conditions. The patient did not have an aortic dissection, bowel perforation, bowel ischemia, or intestinal obstruction that warranted inpatient admission. The patient was able to tolerate a liquid diet. Though this patient required a workup for abdominal pain, the vascular surgeon, rheumatologist, and gastroenterologist did not recommend acute interventions. The patient's computed tomography angiography (CTA) and duplex could have been done in the emergency room with observation status. The patient was stable for an outpatient workup. Thus, inpatient admission was not medically necessary. The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for the inpatient admission is not substantiated.  The insurer's denial should be upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Pneumonia

Treatment: Inpatient admission

The insurer denied the inpatient admission.

The denial was overturned.

This is a female patient with a history of beta-thalasemia minor who had been sick with fever, diarrhea and vomiting for several days. She presented to the Emergency Room (ER) after being evaluated by her pediatrician for dehydration and failure to thrive. It was reported that she had a cough, dizziness, weakness and a decrease in oral fluid intake. A chest x-ray was performed with normal results and a strep culture was done which was negative. In the ER the patient was noted to have tachycardia and a temperature of 100.6. The patient's pulse oximeter was normal and the patient did not have any clinical signs of respiratory distress. A lung examination was performed; crackles were noted. The patient's blood testing was significant for an elevated ESR.  A chest x-ray was done that revealed a left lower lobe subsegmental infiltrate. The patient received intravenous (IV) bolus of normal saline fluid and IV antibiotics. A urinalysis was done with normal results. The patient was admitted to the hospital with a diagnosis of pneumonia. After a period of medical stability the patient was discharged home. 

Based on the review of the medical record, this patient was treated appropriately in the Emergency Room (ER) and was diagnosed with right lower lobe pneumonia. The patient had a history of abdominal pain with nausea and vomiting at home and was not tolerating oral fluids. The decision to admit to the hospital for continued oxygen therapy, antibiotics and nebulized albuterol was appropriate and consistent with the standard of care for treating this pediatric patient with pneumonia and an inability to tolerate oral antibiotics. The patient was recently diagnosed with influenza and she was not able to tolerate antiviral medication at home.  The patient's inability to tolerate oral medication, the evidence of pneumonia on her chest x-ray and her recent influenza illness put this patient at risk for bacterial sepsis and dehydration. Thus, admission to the hospital was appropriate and consistent with the standard of care, and medically necessary for this patient.

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for the acute inpatient admission from is substantiated.  The insurer's denial should be overturned.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cardiac circulatory problems/Coronary artery disease   
Treatment: Inpatient hospital 
The insurer denied the inpatient hospital stay. 
The denial is overturned in whole. 

The patient is a male with a history of hypertension, diabetes type 2, hyperlipidemia, gastroesophageal reflux disease, transient ischemic attack and coronary artery disease with a non-ST elevation myocardial infarction (NSTEMI) and a left heart catheterization. The left heart catheterization showed left main stenosis and 3 vessel disease.
The requested health service treatment (inpatient stay and Coronary Artery Bypass Grafting) was medically necessary for this patient with three vessel coronary artery disease (CAD) and high-risk findings including diabetes and a recent NSTEMI, renal insufficiency, new diagnosis of meningioma, and ongoing anticoagulation at presentation. Due to the high-risk features of his coronary artery disease, discontinuing antiplatelet and anticoagulation therapy was warranted in the inpatient setting with reversible and or parental agents substituted in their place. Further, the coronary artery bypass graft (CABG) timing was appropriate given studies that risk-stratified patients have consistently found that in patients with NSTEMI, revascularization is appropriate at this interval.

The patient presented to the emergency room with a clinical history of worsening symptoms and documentation of three vessel coronary artery disease, diabetes and other high-risk factors favoring revascularization. In addition to the  coronary artery disease, the patient had a non-diagnosed meningioma which required definition prior to operative intervention. Neurological clearance was obtained prior to surgery. The patient additionally was on anticoagulation which needed to be stopped in the hospital setting and bridged with short-acting or reversible anticoagulation in a supervised setting with telemetry given the coronary anatomy (left main coronary artery and three vessel diffuse CAD with total occlusion of the right coronary artery and recent history of NSTEMI).  The patient's coronary artery disease was most appropriately treated with Coronary Artery Bypass Grafting and optimum medical management as was performed in his case.
   
Therefore, the inpatient hospital stay was medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic hypomagnesaemia

Treatment: Acute inpatient stay

The insurer denied coverage for acute inpatient stay. The denial is upheld.

This patient is a female with chronic hypomagnesaemia presented to the Emergency Department (ED) with clinical symptoms consistent with her recurrent low magnesium likely related to the side-effect of one of her medication, proton-pump inhibitor for the treatment of her gastroesophageal reflux disease (GERD). Other than this patient's electrolyte abnormality, the patient was hemodynamically stable with no cardiac arrhythmias. The patient's vitals were: blood pressure 176/88, pulse 89, respirations 18, temperature 98.5F, and blood oxygen level 100% on room air. The patient's electrocardiogram (EKG) showed normal sinus rhythm with no ST-T wave changes.

The patient had no altered mental status or persistent nausea and/or vomiting with dehydration. The patient did not have refractory pain or inability to tolerate oral intake. The patient did not require parenteral nutrition. The patient's hypomagnesaemia responded within 24 hours with intravenous magnesium supplementation. The patient was clinically stable and could have safely received this treatment in a less intensive setting, such as the observation level of care. The literature supports that this patient's condition could have been safely treated under lower level of care, and thus, inpatient admission was not medically necessary.

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for the acute inpatient stay is not substantiated.  The insurer's denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Stage III Carcinosarcoma
Treatment: Genetic Testing
The insurer is denied coverage for genetic testing. 
The denial is upheld. 

Reviewer#3:	

The patient was then a female with a history of stage IIIc carcinosarcoma of the fallopian tube status post neoadjuvant chemotherapy completed on followed by surgical debulking. The patient was planned for adjuvant chemotherapy on the progress note.  A FoundationOne assay with a date of service is under review.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes with FoundationOne assay. 

Ross et al. (2013) performed genomic profiling in relapsed ovarian epithelial carcinoma, which showed that 69% of ovarian cancer patients harbored at least 1 mutation that could be targeted for treatment. Wheler et al. (2016) performed a prospective, nonrandomized, non-blinded study using the genomic profiling from FoundationOne in a wide variety of cancers of which ovarian cancer was highly represented, and noted that patients who were prescribed treatments that matched their genomic profiling results had longer time to failure, higher rates of stable disease but no association with overall survival. At the moment, there are no rigorous randomized studies using the FoundationOne next generation testing that shows improvement in health outcomes in ovarian cancer. Thus, the National Comprehensive Cancer Network (NCCN) guidelines on ovarian cancer (2020), indicate that molecular testing can be considered for ovarian or fallopian tube cancer and the testing should include BRCA1/2, microsatellite instability or DNA mismatch repair and homologous recombination deficiency. However, they do not specifically recommend this testing to be done as part of the FoundationOne assay. Previs et al. (2016) indicates that "genomic profiling has yet to identify any approved molecular targets for ovarian cancer patients with the exception of germline and likely somatic BRCA1 and BRCA2 mutations" and "it is important to note that the only randomized phase 2 trial to date, SHIVA, failed to demonstrate a benefit for targeted therapy." 

Based on the review of the literature, the patient was not a good candidate for genetic testing, (0037U x 1; FoundationOne Dx for cancer of the fallopian tube) performed in 2019. This test assay has not been shown to improve health outcomes. Therefore, there is no population of patient which is considered a good candidate for this genetic testing. Thus, the genetic testing 0037U FoundationOne assay performed in 2019 is not the best available treatment for this patient at this time. Rather, the limited molecular testing, such as with BRCA testing, is the best available procedure to determine which FDA approved medications should be used to treat this patient's fallopian tube cancer. 

Therefore, Foundation One testing is not likely to be more beneficial than any of the standard treatments/procedures for this patient.      

The carrier's denial of coverage for the Genetic Testing (0037U x 1; FoundationOne Dx for cancer of the fallopian tube) performed should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer#2: 

Diagnosis: Stage III Carcinosarcoma
Treatment: Genetic Testing
The insurer is denied coverage for genetic testing. 
The denial is reversed. 


This was then a female patient with the diagnosis of stage IIIC fallopian tube carcinosarcoma. The treating provider ordered next generation sequencing, FoundationOne CDx looking for actionable mutations.

Understanding the molecular drivers of cancer progression and metastases is an area of ongoing and active research, predominantly driven by the goal of identifying specific genomic aberrations that may ultimately result in individualized cancer treatment. While there is no clear data to support targeted therapies, the standard in the community is to obtain next generation sequencing (NGS) testing to determine whether there are actionable mutations. In clinical practice, it is appropriate to send the broader panel rather than trying to pick a handful of genes at a time. Therefore, the FoundationOne Dx is supported by current literature.

According to Kurian, Kingham & Ford (2015), "Next-generation sequencing panels of 6-112 cancer-associated genes are increasingly used in patient care. Studies report a 4-16% prevalence of mutations other than BRCA1/2 among patients who meet evidence-based practice guidelines for BRCA1/2 testing, with a high rate (15-88%) of uninterpretable variants of uncertain significance. Despite uncertainty about results interpretation and communication, there is early evidence of a benefit from multiple-gene sequencing panels for appropriately selected patients... Multiple-gene sequencing panels appear highly promising for the assessment of breast and gynecologic cancer risk, and they may usefully be administered in the context of cancer genetics expertise and/or clinical research protocols." As per Dearfield, et al. (2017), "The recent advances in assaying for and understanding genomic damage, including eventually epigenetic alterations, obviously add a greater wealth of information for determining potential risk to humans. Regulatory bodies need to embrace this paradigm shift from hazard identification to quantitative analysis and to incorporate the wider range of genomic damage in their assessments of risk to humans."

The Genetic Testing (0037U x 1; FoundationOne Dx for cancer of the fallopian tube) performed is Food and Drug Administration (FDA) approved, and more genes are tested in this test compared to the limited testing, and tests for potentially more targets. While there is no clear data to support targeted therapies, the standard in the community is to obtain next generation sequencing (NGS) testing to determine whether there are actionable mutations. In clinical practice it is appropriate to send the broader panel rather than trying to pick a handful of genes at a time.     

Therefore, Foundation One testing is likely to be more beneficial than any of the standard treatments/procedures for this patient.      

The carrier's denial of coverage for the Genetic Testing (0037U x 1; FoundationOne Dx for cancer of the fallopian tube) performed on should be reversed.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Stage III Carcinosarcoma
Treatment: Genetic Testing
The insurer is denied coverage for genetic testing.
The denial is upheld. 

Reviewer #1:

This was then a female who has been diagnosed with a stage III carcinosarcoma of the fallopian tube. The patient was treated with neoadjuvant carboplatin/taxol followed by debulking surgery. Due to grade 2 neuropathy, the patient's adjuvant chemotherapy was switched to carboplatin/taxotere for 3-5 more cycles. After completion of her chemotherapy, the patient was recommended maintenance therapy with Olaparib if she was BRCA 1/2 positive by BRCA 1/2 testing. FoundationOne testing was requested.

According to Montemorano et al. (2019), "PARP inhibitors have shown significant promise in the treatment of ovarian cancer. Olaparib is a PARP inhibitor that has been approved for maintenance for BRCA-mutated ovarian cancer in the recurrent and front-line setting as well as for treatment of BRCA-mutated ovarian cancer in patients who have received multiple prior lines of chemotherapy." As per Moore, K, et al. (2018), "The use of maintenance therapy with olaparib provided a substantial benefit with regard to progression-free survival among women with newly diagnosed advanced ovarian cancer and a BRCA1/2 mutation, with a 70% lower risk of disease progression or death with olaparib than with placebo."      

According to the National Comprehensive Cancer Network (NCCN) (2020) guidelines, those with BRCA mutations will benefit from adjuvant Olaparib or Niraparib. This is an NCCN (2020) category 1 recommendation. The NCCN (2020) guidelines indicate BRCA1/2, microsatellite instability or DNA mismatch repair and homologous recombination deficiency are the appropriate testing in this patient's clinical scenario. The NCCN (2020) guidelines do not specifically recommend the FoundationOne assay.    

In this case, this patient was diagnosed with stage III fallopian tube carcinosarcoma, and had been treated with chemotherapy and surgical debulking. The patient had a very good response to chemotherapy. As such, it must be determined if this patient was BRCA 1/2 positive to determine if she is a good candidate for Olaparib maintenance therapy as per NCCN (2020) guidelines. This can be done by limited molecular testing. The use of FoundationOne Dx is not superior to limited molecular testing. The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome with the use of FoundationOne Dx compared to the limited molecular testing. 

Therefore, Foundation One testing is not likely to be more beneficial than any of the standard treatments/procedures for this patient.      

The carrier's denial of coverage for the Genetic Testing (0037U x 1; FoundationOne Dx for cancer of the fallopian tube) performed should be upheld.