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

Diagnosis:  IBD
Issue under review:  Entyvio

Determination:  
The Entyvio is not medically necessary.

The patient is a young male child.  He was recently diagnosed with very early onset IBD (inflammatory bowel disease) (Crohn's disease) or VEO-IBD (Very Early Onset Inflammatory Bowel Disease).  He was started on Entyvio induction.  His physician requested to continue Entyvio.

This patient has been diagnosed with VEO-IBD (Crohn's disease).  His physician requested vedolizumab as the first choice of treatment.

The FDA approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn's disease.  Entyvio is approved to treat those conditions when one or more standard therapies (corticosteroids, immunomodulators, or tumor necrosis factor blocker medications) have not resulted in an adequate response. 

A multicenter retrospective study at three tertiary IBD centers showed that vedolizumab is efficacious and safe in pediatric patients with Crohn's disease (Singh et al 2016).  Another multicenter retrospective study in Europe also showed that Vedolizumab was safe and effective in this cohort of pediatric refractory IBD including Crohn's disease (Ledder 2017).  In this study, Entyvio was used in children as young as two years old who failed conventional therapy and at least one of the anti-TNF (tumor necrosis factor) agents.

However, there has been no published large study to demonstrate the effectiveness and safety of vedolizumab as the first choice treatment in children with VEO-IBD.  There has been no large study to show that TNF blockers are contraindicated and that vedolizumab is more effective than TNF blockers.  There has been no treatment guideline or consensus to recommend Entyvio as the first choice of treatment in children with VEO-IBD.  Therefore, Entyvio (vedolizumab) should be considered unproven and not medically necessary for the patient at this time.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Cancer 
Treatment:  Radiation Therapy 

This is a patient with a history of prostate carcinoma treated with radiation therapy.  He also has stage IV non-small cell lung carcinoma.  He has a left lower lung primary site of disease and multiple bone metastases.  He had a thoracic (T) 11 vertebral body pathologic fracture post decompression and stereotactic body radiation therapy (SBRT) to T11.  He has been on systemic therapy and now has oligoprogressive disease based on a positron emission tomography (PET) scan showing growth of the left lower lung lesion and no other sites of progression.  Radiation therapy is recommended to this lesion and SBRT with five fractions is requested.  At issue is the medical necessity of the SBRT.  The health plan's determination is overturned. 

The requested treatment of SBRT is considered medically necessary for this patient, as this is the only site of progressing disease in the oligometastatic setting or oligoprogressing disease.  There are excellent data published in peer reviewed journals showing up to a 90% control rate with SBRT to these sites of disease with minimal risk of side effects.  This treatment is also supported by National Comprehensive Cancer Network (NCCN) Guidelines as category 2A support.
Appeal type: Formulary Exception
Decision: Overturned

The patient is a female with a diagnosis of overactive bladder.  Associated symptoms include urinary frequency, urgency and nocturia.  Prior failed therapy includes oxybutynin.  The subject under review is whether the non-formulary drug being requested (Myrbetriq) is likely to be more effective than the formulary drugs for this patient.  

The health plan's determination is overturned.

Yes, all formulary drugs will be ineffective.  All formulary drugs are anticholinergics. The patient has overactive bladder.  The second line therapy includes anticholinergic medications and beta 3 agonists.  The patient is refractory to one anticholinergic medication.
Myrbetriq is a beta 3 agonist which relaxes the bladder by a mechanism which is different than anticholinergic medication.
American Urological Association (AUA) Guidelines for overactive bladder, 2014 states the following, "Clinicians should offer oral anti-muscarinics or oral 3-adrenoceptor agonists as second-line therapy.  If a patient experiences inadequate symptom control and/or unacceptable adverse drug events with one antimuscarinic medication, then a dose modification or a different anti-muscarinic medication or a 3-adrenoceptor agonist may be tried."
European Association of Urology (EAU) guidelines for management of non-neurogenic male lower urinary tract symptoms (LUTS), 2016 states, "beta-3 agonists may be used in men with moderate-to-severe luts who have predominantly bladder storage symptoms."  This drug is Food and Drug Administration (FDA) approved and appropriate for females as well.
As such, use of Myrbetriq would be considered clinically appropriate and generally accepted standard in this patient.
Appeal type: Medical necessity
Decision: Overturned

The patient has a past medical history of stroke, hypertension, vasovagal syncope, moderate to severe dementia (felt likely related to Lewy body disease), chronic back pain and urinary incontinence who had personal care aide services. The patient had 2 assessments. The second assessment did not show any changes in her levels of assistance. The assessments noted the patient was independent with walking and locomotion. It also noted limited assistance with toilet transfer, toilet use, bathing, hygiene, dressing of upper and lower extremity. The patient was noted to be minimally cognitively impaired on assessments. The patient required extensive assistance for medication management and meal preparation. The patient was approved for personal care aide services 4 hours per day/5 days per week to total 20 hours per week. The patient's medical providers requested increased hours of personal care aide services. The patient's neurologist indicates that the patient required at least 8 hours of PCA services to help with ADL's including medication reminders and meal preparation due to progression of known dementia. The patient's primary care provider, supports an increase in PCA services due to the patient's medical condition. The patient had been losing weight due to not eating regularly. The patient was at high risk for falling and the patient had not been taking medications properly. The patient's daughter indicates the patient was having difficulty managing medications often forgetting to take or taking medication too frequently with concern for severe consequences. The patient was not feeding herself, would forget to eat, forget there was food in the home and had been losing weight. The patient needed assistance with dressing, could not manage to put on or take off a sweater. The patient wore undergarments and would place dirty undergarments in hamper on occasions. The patient was having difficulty with personal hygiene as the dementia caused the patient to forget how to do even simple tasks (i.e. putting lipstick on eyebrows). 

Overturn in whole the health plan's determination of medical necessity. Per the patient's providers and patient's daughter, the second assessment done had significant changes in ability to prepare meals and eat, manage medications, manage incontinence cares, bathing, personal hygiene and dressing of upper and lower extremity which would necessitate increased hours of personal care aide services in order to remain independent in the home. The patient needed reminders for medications and meal preparation and eating due to medical condition. The provider specifically requested 8 hours per day. The patient's last assessment indicated the patient was minimally cognitively impaired but the provider and daughter note the patient  has been diagnosed with moderate to severe dementia. The patient's primary care provider supports an increase in PCA services due to the patient's medical condition.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Finger laceration 
Treatment: Inpatient admission 

The insurer denied the inpatient admission. The denial is upheld. 

No, the acute inpatient hospitalization was not medically necessary or indicated, given the clinical information provided. 

The patient is a female. She presented with a ring finger laceration. The patient's parents state that the child was walking with a glass bowl and then fell with it in her hand. The patient was taken to the emergency department where the laceration was evaluated and she was found to have difficulty flexing her ring finger. 

A plastic surgery consultation was requested, and an evaluation was performed in the emergency department. Due to the complex nature of the penetrating injury, the patient was taken to the operating room. She underwent an exploration of the left ring finger laceration with repair of the FDP (flexor digitorum profundus) tendon, radial digital artery and radial digital nerve to the left ring finger. 

The procedure was performed without any complications, and the postoperative period was uncomplicated. The patient was then subsequently discharged. 

The documentation states that the patient suffered from a laceration to the finger, which was seen, evaluated and then treated with surgery. There are no unusual complications in her circumstance that warranted an acute inpatient hospitalization overnight, including but not limited to pain control, which was satisfactory with analgesia. Therefore, there is no medically necessary indication for the hospitalization.  The treatment, including the surgical intervention performed, could have been accomplished on an outpatient basis and follow up on an outpatient basis without any threat to health or function for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Status post cardiac catherization monitoring 
Treatment: Inpatient hospital admission 

The insurer is denied coverage for inpatient hospital admission. The denial is upheld. 

The patient was a male with a history of end stage renal disease (ESRD) on hemodialysis, coronary artery disease status post 3 vessel coronary artery bypass graft (CABG), status post multiple stents and brachytherapy, atrial fibrillation/flutter, status post ablation, diabetes mellitus, hyperlipidemia and cerebra vascular accident. The patient presented needs a cardiac catheterization. The patient had been experiencing exertional dyspnea and angina for the past month. The patient's recent stress test showed reversible ischemia. The patient underwent coronary angiography with radiation oncology assisted brachytherapy to the ramus intermedius coronary artery. There were no procedural complications. The patient was admitted for post-procedure monitoring and was cleared for discharge home. 

Inpatient admission status is not medically necessary for this patient. Per MCG Angioplasty, Percutaneous Coronary Intervention ORG: M-52 (ISC), this procedure is an outpatient procedure. This patient's clinical presentation and peri-procedural course were unremarkable and uneventful, and acute inpatient level monitoring was not medically necessary. There were no extenuating circumstances in this case that warranted inpatient admission status post-procedural of the elective cardiac catheterization and attempted angioplasty. 

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 hospital admission at the acute level of care is not substantiated. The insurer's denial should be upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Periodontal disease 
Treatment: antimicrobial agents on tooth #18 

The insurer is denied coverage for delivery of antimicrobial agents on tooth number 18. The denial is reversed. 

This patient was a male. Based on review of submitted documentation which includes copies of periapical radiographs, as well as comprehensive periodontal chartings, narrative letter from the doctor and insurer correspondence, it appears that this patient exhibited long-standing history of periodontal disease with plaque and calculus accumulation and periodontal pocketing generalized. The recommended treatment was for placement of antimicrobial agent Arestin (minocycline) in the periodontal sulcus in the area of tooth #18. The insurer has denied this service stating that benefits are limited to one tooth in a particular area where the pocket depths of 6-8 mm was present with bleeding on probing. It was their impression that the submitted information did not meet these criteria as the pocket depth for #18 was 9 mm and therefore no benefits can be allowed. The patient is appealing. 

Upon review of the submitted documentation, particularly the periodontal probing and periapical radiograph, there is evidence of periodontal disease affecting #18. Further, alveolar bone loss concomitant with this periodontal disease is noted on the radiograph. The recommended treatment of placement of an antimicrobial, in this case in the form of minocycline is a well-established accepted standard of care in periodontal practice and is a covered service under the patient's insurance contract.  Peer reviewed literature supports this treatment. As the clinical and radiographic information as submitted justify and substantiate this covered service, delivery of antimicrobial agent for tooth #18 is considered medically necessary. 

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 delivery of antimicrobial agents on tooth number 18 rendered is substantiated. The insurer's denial should be reversed.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Bimalleolar Ankle Fracture 
Treatment: Skilled Nursing Facility Admission 

The insurer denied the skilled nursing facility admission. The denial was upheld. 

This is a patient with a history of chronic obstructive pulmonary disease (COPD), hypertension and obstructive sleep apnea. The patient reportedly fell, sustained a right bimalleolar ankle fracture and underwent open reduction internal fixation (ORIF). She was transferred to a skilled nursing facility and was restricted to right lower extremity non-weight bearing status; she received physical therapy. 

The clinical records neither demonstrated a level of functional incapacity, nor was the patient provided the frequency of treatment sufficient to support the medical necessity of inpatient subacute rehabilitation. The patient fell, sustained a right ankle facture that was surgically repaired and was restricted to right lower extremity non-weight bearing status. However, upon admission to the SNF, she was essentially independent with activities of daily living while sedentary and there was no record that occupational therapy was actually provided.  A similar level of functional improvement could have been achieved at a lower level of care (e.g. home physical therapy). Much of the care provided in the SNF was primarily custodial. In addition, there were no complex nursing issues or acute medical problems that required skilled nursing or physician services. 
 
From a physical medicine and rehabilitation/pain management perspective, as well as within a reasonable degree of medical certainty, coverage for the skilled nursing facility (SNF) admission was not medically necessary. 

The healthcare plan acted reasonably and with sound medical judgment and in the best interests of the patient. 

The carrier's denial of coverage for the skilled nursing facility (SNF) admission is upheld.  The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cellulitis of the left foot, Left foot osteomyelitis

Treatment: inpatient admission

The insurer denied coverage for inpatient admission.

The denial is upheld.

This is a male patient with a past medical history significant for diabetes mellitus, hypertension, coronary artery disease, non ST elevation myocardial infarction, benign prostatic hypertrophy, and status post prostatectomy who presented to the emergency department with complaints of left foot pain and discharge. Laboratory results included white blood cells 11.7.

The patient was started empirically on broad-spectrum intravenous antibiotics (vancomycin, Zosyn), for a left foot infection. Magnetic resonance imaging was negative for osteomyelitis, but showed cellulitis and myositis. He underwent a debridement in the operating room. A wound vacuum assisted closure (VAC) device was applied. He required additional revisions and excisional debridement. Infectious Diseases recommended antibiotic adjustments. A peripherally inserted central catheter (PICC) line was inserted for administration of long-term antibiotics for treatment of osteomyelitis. He improved clinically, remained afebrile, hemodynamically stable, and was discharged to continue management in a less acute setting.   

According to submitted documentation, the patient presented to the hospital with a left foot infection. Based on the information provided, acute inpatient care cannot be deemed medically necessary.   

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

The medical necessity for the inpatient admission is not substantiated. The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Presumed Sepsis

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission.

The denial is upheld.

This is female patient who presented to the Emergency Department (ED) with complaints of bilateral hand numbness and palpitations. She also had complaints of nausea, vomiting, fever, and cough with occasional brownish sputum. Her vital signs in the ED were: temperature (T) 102.5F, heart rate (HR) 126, respiratory rate (RR) 18, blood pressure (BP) 137/86 mm Hg, and oxygen saturation 96% on room air. On exam, the patient was noted to be in some distress; however, there were no abnormal findings noted. She was admitted with a diagnosis of presumed sepsis. 

The patient was treated with intravenous (IV) fluids, Pepcid, Zofran and broad spectrum IV antibiotics, including vancomycin and Zosyn. The patient's electrocardiogram (EKG) showed sinus tachycardia. A computerized tomography (CT) scan of the chest revealed some ground-glass opacity that was suspicious for bronchitis vs. bronchopneumonia. Her physical exam was unremarkable. Blood culture/sensitivity results were negative, and urinalysis (UA) and influenza test were also negative. 

Based on the review of the medical record, this patient did not need acute inpatient hospitalization. She could have been placed on observation status for up to 48 hours if needed. Diagnostic testing and treatment could have been initiated during this phase.  The patient responded to initial antibiotics; her fever and tachycardia improved. She was ambulatory, nontoxic, and on day 2 of admission her oxygen saturation was 100% on room air. Her white blood cell (WBC) count was down-trending. 

The patient's pneumonia, if present, was likely mild. Her pneumonia severity, CURB 65 score was 0. She was afebrile within 24-hours of treatment and was not hypoxic. The patient subjectively felt better. She was tolerating oral intake and could have been switched to oral antibiotics and discharged home with close follow-up in an outpatient setting after a period of observation. Thus, inpatient admission was not medically necessary for this patient.

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

The carrier's denial of coverage for inpatient admission should be upheld. The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

This is a patient with a history of hypertension and diet-controlled diabetes.  She presented to the emergency department complaining of several episodes of nonexertional substernal chest pain that lasted approximately one minute each.  She reported poor oral intake for several days prior to presentation.  Her cardiovascular exam was unremarkable.  Her cardiac biomarkers were normal.  Her electrocardiogram showed T wave inversions in leads V1-V3 without ST segment abnormalities.  Her hematocrit was elevated at 55%.  Her blood urea nitrogen (BUN) was 38 milligrams per deciliter (mg/dl) with a creatinine of 1 mg/dl.  She was treated with intravenous heparin and hydration and admitted to the hospital to rule out acute coronary syndrome.  An echocardiogram showed normal left ventricular systolic function.  Hematology consultation was obtained.  The patient's hematocrit was 49.8% after hydration.  Her blood urea nitrogen (BUN) decreased to 30 mg/dl with a creatinine level of 0.8 mg/dl.  The polycythemia was thought to be due to dehydration versus possible polycythemia vera.  Further laboratory testing was recommended.  A chest, abdominal and pelvic computed tomography (CT) scan showed no evidence of malignancy.  Myocardial perfusion imaging showed no evidence of ischemia.  The health plan's determination is upheld.  

This patient presented with atypical chest pain that was thought to possibly represent acute coronary syndrome (ACS).  Accordingly, observation until acute coronary syndrome (ACS) could be ruled out was a reasonable approach.  However, she was hemodynamically stable, with normal cardiac biomarkers.  While her electrocardiogram was abnormal, the abnormality was not diagnostic for ischemia.  There is no indication in the records provided that other potentially life-threatening causes of her chest pain were thought to be likely.  The care this patient received did not require an inpatient admission and could have been provided at a lower level of care.  This approach has been shown to be safe and and is in accordance with the 2014 American Heart Association (AHA) / American College of Cardiology (ACC) Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes.

Per the Milliman Care Guideline for Chest Pain (ORG: M-89) inpatient admission is indicated for chest pain and 1 or more of the following: 1) Hemodynamic instability. (Not met) 2) Respiratory distress. (Not met) 3) Chest pain indicative of serious diagnosis other than coronary artery disease (eg, aortic dissection). (Not met) 4) Angina or myocardial infarction.  

The patient did not meet accepted clinical criteria for myocardial infarction and her symptoms were atypical for angina.