Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned

Primary Diagnosis:  Cancer / Neuroendocrine. 
Primary Treatment:  Pharmacy / Prescription Drugs. 
The insurer denied the Lorbrena.  The denial should be overturned.

The patient  diagnosed with high risk neuroblastoma with central nervous system (CNS) recurrence.  He was diagnosed  after presenting with a 3-week history of abdominal pain and fever.  Medical imaging revealed a large retroperitoneal mass.  The patient  was enrolled on Children's Oncology Group (COG) clinical trial ANBL00B1.  The pathology confirmed neuroblastoma of unfavorable histology metastatic to the bone marrow, MYCN non-amplified and no ALG aberrations.  The patient was enrolled and treated on ANBL1531 and was randomized to arm C including 131-I-MIBG therapy plus a single hematopoietic stem cell transplantation (HSCT) using Bu/Mel for consolidation.  The health plan's determination is overturned in whole.  Lorbrena is likely to be more beneficial than standard treatment.

The National Cancer Institute (NCI) sponsored Molecular Analysis for Therapy Choice (MATCH) trial as well as other national trials are identifying targetable alterations present in childhood cancer tumor samples.  The goal is to identify alterations, which present pathologic targets for which there is a known or identifiable drug that can be administered to the patient.  ALK-mutations have been identified in a number of tumors.  Crizotinib is a drug that has been used in ALK-positive Non-small-cell lung carcinoma (NSCLC) with remarkable efficacy.  This drug does not cross the blood brain barrier, so is not indicated nor beneficial for central nervous system (CNS) metastases.  Clinical studies in neuroblastoma show that Crizotinib is not effective as the activating mutations in the ALK kinase domain are refractory to this treatment.  More potent inhibitors are required to achieve clinical efficacy.  The NANT consortium currently maintains Lorlatinib penetrates the blood-brain barrier and distributes throughout the CNS, so it is ideal for CNS metastases.

National Comprehensive Cancer Network (NCCN) guidelines are predominately and almost exclusively for adult cancers.  Neuroblastoma is a childhood cancer that is very rarely present in adults.  Food and Drug Administration (FDA) approval for medications in pediatrics lags behind adult approvals and is challenging for medications for childhood cancers that do not occur or are rare in adults.

The NANT clinical trial has very encouraging early response data for this drug.  It penetrates the CNS, which strongly supports its use in neuroblastoma of the CNS.  Based upon preclinical data and the ongoing clinical trials with encouraging results and the strong genetic analysis identifying the ALK mutation, the use of this drug is warranted and supported.  This drug offers a potentially effective treatment to improve the long-term outcome and quality of life of this child.
Appeal type: Experimental/Investigational
Decision: Overturned

Primary Diagnosis:  Cancer / Neuroendocrine. 
Primary Treatment:  Pharmacy / Prescription Drugs. 
The insurer denied the Loratinib.  The denial should be upheld.

The patient with high risk neuroblastoma (based on unfavorable histology, bone marrow disease).  The patient  was treated with standard of care therapy following diagnosis. The  end of therapy restaging studies revealed a new metastatic central nervous system (CNS) lesion in the  left frontal lobe.  The patient underwent complete resection of this lesion followed by gamma knife stereotactic radiation.  The health plan's determination is upheld in whole. 

There is currently no standard of care for relapsed neuroblastoma with CNS metastases.  There are clinical trials available for relapsed neuroblastoma; however, this patient has no measurable disease; thus, is it unlikely he will be eligible for any trials at this time.  Unfortunately, it is only a matter of time until he will develop disease in another site.

Loratinib is currently in a phase I trial through the New Approaches to Neuroblastoma Therapy (NANT) consortium for pediatric patients.  Pre-clinical evidence of it being efficacious in patients with ALK activating mutations is encouraging.  However, there is insufficient clinical data to support that it is beneficial over other therapies available for recurrence.
Appeal type: Experimental/Investigational
Decision: Overturned

Primary Diagnosis:  Cancer /Neuroendocrine. 
Primary Treatment:  Pharmacy /Prescription Drugs. 
The insurer denied the Loratinib.  The denial should be overturned.

The patient has a diagnosis of recurrent neuroblastoma.  The patient  initially presented for care of abdominal pain and fever.  Imaging showed a retroperitoneal mass and lymphadenopathy.  The patient  was noted to have metastatic disease (widespread to include the bone marrow) at the time of diagnosis.  With the relapse the patient was found to have a new activating ALK mutation.  The patient  currently has no measurable disease post radiation therapy, so he is not considered eligible for a phase I clinical trial with an ALK inhibitor, such as the NANT protocol 2015-02 with Lorbrena.  The provider is now recommending that the patient receive treatment with Lorbrena off of study.  The health plan determination is overturned in whole.

The use of ALK inhibitors as single agent therapy in neuroblastoma has been reported in the literature.  As per Guan et al., while Crizotinib is not noted to be effective in neuroblastoma, there have been promising results with Lorbrena (PF-06463922) as single agent therapy in this disease.  Infarinato et al. also noted that Lorbrena was successful in overcoming the resistance noted in Crizotinib therapy, recommending that this product be fast tracked in development for treatment of recurrent or refractory neuroblastoma.

Vasseur et al. demonstrated high sensitivity for adult patients with resistant ALK positive neuroblastoma that failed treatment with Crizotinib, and Umapathy et al. noted that this is one of the few agents that can pass the blood brain barrier, overcoming also all known ALK resistance mutations observed with the other similar ALK inhibitor products.  This product was noted to be more potent both in vivo and in vitro and is a potentially highly useful product for those with CNS disease.
Appeal type: Medical necessity
Decision: Upheld

Digestive System / Gastrointestinal
Inpatient Hospital

The patient is a female who presented to the emergency department (ED) with right sided abdominal pain. At the time of presentation, the patient was without fever and vital signs were normal. She was tender in the right upper abdomen. The white blood cell (WBC) count was elevated at 14.2 thousand (K). The complete metabolic panel was normal. Computed tomography (CT) scan showed findings of cholecystitis and biliary ductal dilatation. She was further evaluated with magnetic resonance cholangiopancreatography (MRCP) that showed a normal common bile duct. She was initially treated with intravenous (IV) fluid and IV antibiotics. She was treated with laparoscopic cholecystectomy. The operative dictation and the anesthetic record describe an uncomplicated cholecystectomy procedure. The patient was treated with post-surgical monitoring, IV fluid, IV analgesia, and antiemetics. The immediate post-surgical recovery was uncomplicated. On post-operative day #1 following surgery, the patient had stable vital signs. Pain was controlled. The diet was advanced. The patient remained clinically stable and was discharged from the inpatient setting.

The health plan's determination is upheld in whole.

Based on the submitted clinical documentation, an inpatient level of care was not medically necessary. This patient was admitted to the hospital with the diagnosis of cholelithiasis/cholecystitis. There is no documentation of hemodynamic, pulmonary, neurological, or metabolic reason for an acute inpatient level of care. Additionally, there is no documentation of failure to achieve discharge criteria, conversion to open surgery, care for comorbidities, procedural complications, or any other condition requiring inpatient admission. The patient underwent an uncomplicated laparoscopic cholecystectomy procedure. There were no peri-operative complications or other clinical issues that mandated an inpatient designation. She remained stable and was discharged from the hospital.
Inpatient admission may be indicated for acute cholangitis, common bile duct obstruction, vomiting that is severe or persistent, dehydration that is severe or persistent, hemodynamic instability, severe pain requiring acute inpatient management, signs of intestinal obstruction, bacteremia, need for percutaneous or open procedures, or other condition that requires inpatient admission. In this case, none of these indications existed to justify an inpatient level of care.
The medical record supports that the patient could have been reasonably and appropriately treated with a lower level of care status.
Appeal type: Medical necessity
Decision: Upheld

The patient has a history of insulin-dependent diabetes mellitus (IDDM), hypertension (HTN), cerebrovascular accident (CVA) x3, hyperlipidemia (HLD), hypothyroidism, schizophrenia, and chronic kidney disease (CKD) stage 4. The patient presented to the emergency department (ED) with a multitude of symptoms. The patient complained of generalized dizziness, lightheadedness, headache, fatigue, chest pain, palpitations, mild shortness of breath (SOB), blurry vision, high blood pressure (recorded systolic blood pressure (SBP) 198 millimeters of mercury (mmHg) at home). The patient felt that death was imminent. The work up revealed a sodium (Na) of 125, a hemoglobin (Hb) of 8.6 (down from 9.7 in 5/2019), a creatinine of 2.8, a blood urea nitrogen (BUN) of 33 and a glucose of 57. Troponin was negative. The patient did not eat much on the day of admission and took the regular dose of Insulin. The patient also had been drinking an excessive amount of water. Other work up results included an electrocardiogram (EKG), a computed tomography (CT) of the head, and a chest x-ray (CXR) which were unremarkable. The patient was admitted with psychogenic polydipsia and symptomatic hypoglycemia and received intravenous (IV) D50 (dextrose) and SC (subcutaneous) Octreotide. The patient was placed on fluid restriction, and every 2-hour accuchecks. Nephrology and endocrine were consulted. The patient remained stable with controlled blood sugars (BSs) and the Na improved to 129, which is close to baseline. The patient was discharged home with a plan for close follow up. 

The health plan's determination of medical necessity is upheld in whole. 

No. The requested health service/treatment of an inpatient stay was not medically necessary for this patient, who did not have evidence of persistent hypoglycemia, severe electrolyte abnormalities, severe organ failure, or uncontrolled HTN requiring parenteral meds. There was no evidence of cardiac ischemia or cerebral infarction. There were no persistent neurological deficits. The patient responded well to treatment and returned home the next day. 

Upon review of the chart, scientific literature, and standards of practice, the patient could have been safely evaluated and treated at a lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Substance Abuse/Addiction 
Treatment: Substance Abuse: Inpatient 

The patient is a male who was brought to the emergency department by emergency services and admitted following medical screening to acute inpatient level services for monitoring and detoxification and withdrawal management of severe alcohol and opioid use disorders. He had a ten year history of severe substance use. The patient was currently using large amounts of alcohol with up to five pints of vodka per day, and fentanyl and intermittent use of heroin with up to 4 bags with intravenous (IV) administration. The patient had experienced severe alcohol and opioid withdrawal in the past and had mild withdrawal at the time of admission with use the day before or day of his presentation. He had frequent blackouts and history of overdoses with the fentanyl, but denied withdrawal seizures or delirium tremens. He had experienced severe withdrawal symptoms in the past requiring detoxification including detoxification treatment three to four months previously with relapse. Additionally, he had been participating in medication assisted treatment with Suboxone and had stopped this treatment. 

The health plan's determination is overturned. The patient in this case presented with a diagnosis of severe alcohol and opioid use disorders and a drug screen suggesting poly-substance use with other substances including sedative-hypnotic-anxiolytic and stimulant use disorders (benzodiazepines and cocaine) with history of severe alcohol and opioid withdrawal and inadvertent overdoses on fentanyl in the past. The patient also has severe psychosocial stressors with limited supports and functional impairments and homelessness. 

The presenting clinical features and history and risk for withdrawal seizures and other complications of alcohol and opioid use disorders did warrant the admission and continued inpatient level services with medical monitoring in this case scenario. Moreover, the patient had recently stopped medication assisted treatment with Suboxone and the patient's admission and continued inpatient stay with detoxification, withdrawal management, and other medical services through discharge could not have been provided at a lower level of care in this case scenario.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Severe recurrent major depressive disorder
Treatment: Formulary exception for Spravato

The health plan should cover the Formulary exception for Spravato.

The patient is a male. He has a diagnosis of major depressive disorder, recurrent, severe, without psychotic features. His symptoms include disrupted sleep, depressed mood, anxiety, anhedonia, sadness, low energy, low concentration, poor appetite, and intermittent suicidal thoughts. He has not responded to multiple antidepressants, including Lexapro and Wellbutrin, or to transcranial magnetic stimulation (TMS). He was recently prescribed esketamine nasal spray (Spravato). Coverage was denied by his insurer. 

The rationale for denial of a formulary exception provided by the insurer was, "Standard Spravato policy does not allow coverage of Spravato if the patient has a current or recent history (within the last six months) of a specific disorder." 

This patient's history and symptoms are consistent with a diagnosis of treatment-resistant depression. The requested medication, Spravato, has been shown in well-controlled clinical studies to be effective in patients with treatment resistant depression. It was approved by the FDA for this purpose on a "fast track" basis. The Insurer's basis for denial is vague and clinically irrelevant.
Appeal type: Medical necessity
Decision: Upheld

DX: Digestive System/Gastrointestinal
Tx: Inpatient Hospital
Denied: Inpatient Stay
Denial: Upheld in whole

This case involves a male with a history of focal sclerosing glomerulonephritis who presents to the hospital with complaints of left leg pain, nausea, vomiting, and headache. The patient also has a history of recurrent Clostridium (C.) difficile and has been experiencing worsening diarrhea bowel movements. He is poorly compliant with diuretic therapy and has gained about 15 pounds. He recently started to develop some lightheadedness, and near syncope. He denied chest pain. The patient had been treated in the past for his kidney disease with corticosteroids, cyclosporine, Rituxan, and tacrolimus without improvement.

Vital signs in the emergency department included a normal temperature, heart rate of 90, respiratory rate of 18, and blood pressure of 159/72. He was well-developed in mild distress on physical exam. He was obese. The cardiovascular exam was normal. He did have preserved pedal pulses, and both legs have nonpitting edema with the left slightly greater than the right.

Laboratory studies revealed a normal brain natriuretic peptide (BNP), blood urea nitrogen (BUN) of 22, and a creatinine of 3.1. Potassium was slightly low at 3.1. Albumin was very low, at 1.7. The white blood cell count was also elevated at 16,000, with a hemoglobin of 9.7. A lower extremity duplex of the veins in the emergency department failed to demonstrate deep vein thrombosis.

The patient was admitted to the hospital for edema of the lower extremities and leukocytosis, possible cellulitis, and renal failure. Blood cultures were obtained, and broad-spectrum antibiotics were started for the patient.

The health plan's determination is upheld in whole.

The inpatient stay was not medically necessary. The patient presented to the hospital with lower extremity edema primarily, and some bouts of nausea and vomiting at home with a near syncopal episode. He was hemodynamically stable without evidence of clear orthostasis or profound hypotension. The patient had a known history of focal sclerosing glomerulonephritis with a baseline creatinine of about 3. His creatinine was only slightly elevated above baseline. He responded very well to diuretic therapy. Also, the patient was actively treated on arrival for recurrent C. difficile infection, which caused mild electrolyte derangements. After switching the patient to the standard of care treatment for C. difficile infection, he rapidly improved in both clinical status as well as laboratory findings, including improvement in the leukocytosis. The leg edema appears more consistent with volume overload from nephrotic range proteinuria, which responded to diuretic therapy. There is no clear evidence of cellulitis, and a deep vein thrombosis (DVT) was ruled out in the emergency department. Therefore, there are no significantly decompensated medical conditions to warrant inpatient hospitalization. The above presentation could have been managed under a lower level of care status.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Skin infection
Treatment: Inpatient admission
The insurer denied the inpatient admission. The denial is upheld.  

The proposed inpatient admission was not medically necessary.

Human immunodeficiency virus (HIV)-positive male was admitted through the ER with a scrotal abscess.  He had been called back to the ER from an evaluation for scrotal pain the previous day.  Vitals were 97.7-123/73-16.  Computed tomography (CT) imaging demonstrated a scrotal abscess adjacent to the perineum.  The white blood cell (WBC) count was 10,900.  Intravenous (IV) antibiotics were started and urology was consulted.  On the same day, the patient had an incision and drainage of a perianal abscess under local anesthesia with IV sedation. He was discharged home.

Treatment of an afebrile perianal abscess with IV antibiotics and drainage did not require an acute inpatient level of care.  The patient did not have complicating features such as obstruction, solitary kidney or sepsis.  Care could have been provided at a lower level of care, such as observation.  There were no compelling reasons to support an acute inpatient level of care on admission.    The patient remained hemodynamically stable throughout.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hip pain status post fall
Treatment: Inpatient admission
The insurer denied the inpatient admission. The denial is overturned.

The acute inpatient hospitalization was medically necessary.

This is a  female with multiple comorbidities that included coronary artery disease (CAD), chronic alcohol (ETOH) abuse and third toe amputation. She had fallen two days prior to her visit to the emergency department (ED). She had hip pain. Imaging studies did not reveal evidence of pathology (computed tomography [CT] and x-ray). She did not have any other conditions. A ventilation-perfusion (VQ) scan showed no pulmonary embolus (PE). There was no evidence of deep vein thrombosis (DVT).  

*The patient was admitted "out of concern for acute coronary syndrome vs. life threatening arrhythmia and traumatic injuries secondary to fall."

The medical record demonstrates the patient has several comorbidities (IE, status post [s/p] cardiac stents, hypertension, obesity and kidney disease). She recently sustained trauma with vague cardiac symptoms. She would be at extremely high risk for a cardiac event. Her physicians obtained several diagnostic studies including echocardiogram, VQ scan, venous Doppler, and CT of pelvis.  She received consultations from several physicians (Nephrology, Cardiology, Endocrinology, Orthopedics and Physiatry). Her vital signs denoted a systolic blood pressure (BP) of 190. Her blood glucoses were erratic and required administration of D50. Her cardiac enzymes were abnormal.  The patient required ongoing management from her sub specialists.  These findings substantiate the necessity of admission and length of stay.  These services could not have been provided at lower level of care (IE, multiplicity of conditions which were not stable, high risk and need for treatment by many practitioners until stabilized).
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Bronchiolitis
Issue under review: Inpatient admission
The health plan denied Inpatient admission

Determination:
The health plan's denial is overturned.

The patient is a male infant with pectus excavatum that presented to the ED with several day history of cough, nasal congestion, and fever. He was seen by his pediatrician, diagnosed with presumptive RSV (respiratory syncytial virus) infection, and prescribed nebulized saline with minimal relief of congestion. He was taken to the ED via EMS with increased work of breathing and perioral pallor. 

The patient's vital signs included temperature 100.8, heart rate 160, respiratory rate 30, and oxygen saturation 99% in room air. Examination was significant for moist oral mucosa, copious nasal discharge, pectus excavatum with some accessory muscle use, no focal lung findings, cough, normal capillary refill, and non-focal neurologic exam. Laboratory evaluation revealed negative influenza and positive RSV. Blood work and urinalysis were essentially unremarkable. Chest x-ray revealed a patchy opacity in the left lower lobe. 

The patient was treated with a dose of Tylenol and two normal saline boluses followed by maintenance IV fluids. He was placed on non-invasive ventilation with 40% supplemental oxygen, PEEP (positive end expiratory pressure) 6, and pressure over PEEP 10, and admitted to the PICU (pediatric intensive care unit) for further management. Admission orders included ongoing non-invasive ventilation, ceftriaxone to treat secondary pneumonia, nothing by mouth with IV fluids at maintenance, and Zantac for GI (gastrointestinal) prophylaxis. He was gradually weaned to nasal cannula oxygen by hospital day two and his diet was advanced as tolerated. 

The patient was transferred from the PICU to the Pediatric ward that day. He was able to tolerate weaning to room air with no desaturations or increased work of breathing. He remained stable overnight and was deemed stable for discharge home to complete a ten-day antibiotic course with Omnicef.

This young male infant with pectus excavatum had been sick for several days prior to presentation, had been to the pediatrician and presumptively diagnosed with RSV, and was treated with nebulized saline. He developed worsening respiratory distress as well as perioral pallor so was taken to the ED. He was found to have a left lower lobe infiltrate in addition to infection with RSV. He was placed on non-invasive ventilation in the ED with improvement and was transferred to the PICU for further management. He was able to wean overnight from high flow with 40% oxygen to 2 LPM nasal cannula oxygen, with further improvement in symptoms. This level of care is most consistent with acute inpatient management. He had failed outpatient management as well as management in the ED, requiring ICU admission. The full duration of his hospital stay was appropriate at acute inpatient level of care.