Persius/hicric huggingface dataset:
Appeal type: Step Therapy
Decision: Upheld

Diagnosis: Ulcerative Colitis
Issue under review: Entyvio

Determination:
The Entyvio is not medically necessary.

The patient has moderate to severe ulcerative colitis and has failed conventional therapy. She is in need of biologic agent. The plan-preferred agent is Humira. Both anti-TNFs (tumor necrosis factor) and Entyvio are recommended in moderate to severe ulcerative colitis patients who are biologic naive. The health plan-preferred agent is Humira, and as there is no medical literature that conclusively reports an improvement in health outcomes in such patients who are treated with Entyvio as compared to Humira. The proposed Entyvio is not medically necessary, provided that the patient is treated with the preferred agent. The health plan acted reasonably, with sound medical judgment and in the best interest of the patient by denying it.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Asthma
Treatment: Inpatient admission

The inpatient admission was medically necessary.

The patient is a male child with medical history significant for mild persistent asthma, allergy to eggs, attention deficit hyperactivity disorder (ADHD), speech delay, and learning disabilities that was taken to the emergency department (ED) from school via EMS because of cough and wheezing. He had two-day history of cough and wheezing, and had been seen in the ED that morning for shortness of breath. He was treated with enteral steroids, three albuterol nebs, and a dose of Benadryl with significant improvement. He insisted on going to school, not receiving any medications there despite the recommendation to use albuterol every four hours. He began coughing and wheezing so EMS was contacted and he was taken to the ED. En route to the hospital he received one albuterol and supplemental oxygen. 

The patient's vital signs included temperature 37, heart rate 129, respiratory rate 30 with oxygen saturation 97%, and blood pressure 112/77. Examination was significant for mild respiratory distress, moist mucous membranes, bilateral expiratory wheezing, mild suprasternal retractions, able to speak in four to five word sentences, and non-focal neurologic exam. Laboratory evaluation revealed negative influenza. Chest x-ray revealed mild peribronchial thickening consistent with upper respiratory infection. He was treated with three back-to-back DuoNebs spaced to albuterol every two hours, as well as supplemental oxygen at 1.5 liters (L) per minute. He remained tachypneic with intercostal and suprasternal retractions, so he was admitted for ongoing management of asthma exacerbation secondary to upper respiratory infection. Historically, the patient had two pediatric intensive care unit (PICU) admissions with no intubations. Admission orders included nebulized albuterol every two hours, prednisolone daily for total five days, oxygen as needed to maintain saturations greater than 92%, continue home medications (montelukast), regular diet, and anti-pyretics as needed. He tolerated albuterol wean to every three hours following admission. Low dose inhaled corticosteroid was added as part of step-up therapy and asthma education was done. The patient continued to improve, and was tolerating albuterol every four hours. He was deemed stable for discharge with close outpatient follow-up.

This male child presented to the ED for the second time in one day with wheezing, tachypnea, and retractions. He remained symptomatic following treatment in the ED, so was admitted on albuterol every two hours and supplemental oxygen. He had failed outpatient management twice, and was not appropriate for continued outpatient care. His inpatient admission and hospital stay were medically necessary, consistent with the current standard of care.
Appeal type: Medical necessity
Decision: Upheld

The patient is a female with a history of gastroesophageal reflux disease (GERD), hypertension (HTN), hyperlipidemia, congestive heart failure (CHF), chronic kidney disease (CKD), diabetes mellitus (DM) type II, and membranous glomerulonephritis who presented to the hospital with dyspnea on exertion and bilateral lower extremity edema.  She went to her primary care physician (PCP) the day of presentation and was found to have an elevated blood pressure, so she was referred to the emergency room. She was diagnosed with membranous glomerulonephritis in 2017, and the lower extremity swelling has been problematic ever since.  She is short of breath after walking two blocks and also states she needs 2 pillows to sleep, being unable to sleep lying flat.  She denies fevers or chills but does have a chronic dry cough.  Her vital signs showed that she was afebrile with a blood pressure of 179/82, a pulse of 64, a respiratory rate of 16, and a room air pulse oximetry of 100%.  Her exam showed that she was in no acute distress with clear lung fields and 2+ bilateral lower extremity edema.  Her labs showed a white blood cell (WBC) count of 7.9, a hemoglobin of 10.3, a creatinine of 3.25, a blood urea nitrogen (BUN) of 34, a potassium of 4.2, and a brain natriuretic peptide (BNP) of 5097.  A chest x-ray showed no airspace disease or pleural effusions.  She was admitted for treatment of her lower extremity edema and started on intravenous (IV) Lasix therapy.  Cardiology and nephrology were consulted during this admission.  The patient was felt to be stable enough for discharge.

The health plan's determination is upheld.

The inpatient stay is not medically necessary for this patient.
The patient presented with lower extremity edema which appeared chronic in nature per the documents provided. She was hypertensive on presentation but did not meet criteria for inpatient management of her hypertension such as acute cardiac or cerebrovascular ischemia, ruptured abdominal or thoracic aneurysm, acute kidney injury, malignant retinopathy, severe and persistent altered mental status, acute respiratory distress from congestive heart failure or other signs of imminent end organ damage. She was otherwise hemodynamically stable; she had no evidence of respiratory distress, nor was she hypoxic.  There was no documentation that the patient had failed outpatient management of edema of her lower extremity with oral diuretics.  There was no documentation for any other medical indication for an inpatient admission.  The patient could have been safely and effectively managed at a lower level of care status.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Out-of-position canines
Treatment: Braces and monthly visit

The braces and monthly visit are medically necessary. 

The patient's upper canines are not in their proper position. Canines are very important teeth in that they help guide the teeth to mesh properly during the chewing cycle. Without these teeth in their proper position, other teeth will bang into each other too hard, and over time, fractures and/or other trauma will occur. Also, over time, there is an increased chance of TMJ (temporomandibular joint) problems due to the bite causing increased pressure in the joints. Orthodontic treatment will correct these problems. This case has a medical necessity for orthodontic treatment.

In addition, monthly visit is needed to change/reconfigure the orthodontic wires and to monitor the changes in tooth positions.
Appeal type: Medical necessity
Decision: Upheld

This is a patient  with a history of hypertension, diabetes, dyslipidemia, seizures, cerebrovascular accident (CVA), and schizophrenia who presented to the hospital with a chief complaint of syncope. He reported that he fell asleep suddenly while at a program for training. He was told that he was difficult to awake after the episode but he denied nausea, lightheadedness, and headaches.  After waking he had no recollection of what happened.  The patient was admitted for syncope and acute kidney injury. The health plan's determination is upheld. The plan of care for the patient included cardiac enzymes, telemetry, echocardiogram, ultrasound of the carotid arteries, neurology consult, cardiology consult, intravenous (IV) fluids, and monitoring kidney function. Home medications were also continued. The echocardiogram demonstrated normal left ventricular ejection function and grade one diastolic dysfunction.  A head computed tomography (CT) scan showed an old stroke but no acute stroke.  A carotid Doppler ultrasound did not show critical stenosis. He was also continued on Keppra for seizures but had no acute seizures during the hospitalization.  The patient had a non-acute presentation of uncomplicated syncope.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Rule out acute coronary syndrome

Treatment: Inpatient stay

The insurer denied coverage for inpatient stay. The denial was upheld.

This patient is a man with a past medical history notable for coronary artery disease, myocardial infarction, prior stenting, cardiomyopathy, and chronic tobacco use.  He presented to the ER with complaints of persistent chest pain. He had been seen in the ER a few days prior for cough and signed out against medical advice. He had a known cardiomyopathy with ejection fraction 25-30%, and an AICD was previously recommended. Vital signs, physical examination and cardiac troponins were negative. He was admitted to rule out acute coronary syndrome. Urine toxicology was positive for opiates and cocaine. He was counseled on the need for a lower extremity angiogram and AICD however the patient signed out against medical advice.

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

The patient presented with chest pain, however the initial evaluation in the ER was unremarkable, including a nondiagnostic EKG. Inpatient admission was not medically necessary for this patient. The patient's care could have been provided in the observational setting, allowing for additional cardiac testing. Further evaluation was warranted, however inpatient admission criteria was not met.  The patient's symptoms were chronic and longstanding, not suggestive of myocardial ischemia, and medical criteria were not met for any other additional extenuating circumstances. Although he was counseled about the need for a lower extremity angiogram and AICD, there was no indication these procedures were emergent and needing to be performed while inpatient. 

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

Diagnosis: Near syncope
 
Treatment: Inpatient admission, monitoring

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

The patient was a woman with a history of hypertension, gastrointestinal reflux disorder (GERD), and asthma.  She was seen in the ER for lightheadedness with near syncope, palpitations, leg weakness, and cramping. She'd been treated with pseudoephedrine 2 weeks prior. She attributed her symptoms to decreased oral intake in an attempt at losing weight. There was no vertigo or orthostasis on examination. Her vital signs and physical examination were unremarkable. She was ruled out for myocardial infarction. The echocardiography showed ejection fraction 50-55%. The electrocardiogram (EKG) showed normal sinus rhythm. She clinically improved and was discharged home. 

The patient presented with near syncopal events; however, there were no signs or symptoms of hemodynamic instability, myocardial ischemia, arrhythmia, heart failure, cerebrovascular insufficiency or other organ dysfunction requiring inpatient admission status. Her care could have been rendered under observational level of care with up to 23 hours of monitoring, or could have been administered solely in the emergency department. The inpatient level of care was not appropriate.   

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

Diagnosis: Vomiting and abdominal pain
 
Treatment: Inpatient admission, intravenous fluids, monitoring

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

This was a male child with a history of an appendectomy 3 months ago. He presented to the Emergency Department (ED) for evaluation of vomiting x 1 day associated with 4/10 periumbilical discomfort, fever and headache. The patient had 10 vomiting episodes and fever to 101F the day prior to presentation, but was tolerating liquids. The patient's vitals on arrival were: heart rate 112, temperature 98.4 F, respiratory rate 23, and blood pressure 111/73. Exam showed a healthy child in no distress. His lips were dry and skin turgor was normal. His abdomen was soft with mild tenderness to palpation. Bloodwork results included sodium 141, potassium 3.6, Blood urea nitrogen 13, creatinine 0.65, chloride 106, bicarbonate 24, white blood cell count 3.7, hemoglobin 13.1, platelets 334, Aspartate Aminotransferase (AST) 27, Alanine Aminotransferase (ALT) 16, and bilirubin 0.4. Urinalysis showed specific gravity > 1.030 and pH 6. An abdominal x-ray was unremarkable. He was given IV fluids and was admitted because of his surgical history and abdominal pain. 

This patient appears to have a mild viral gastroenteritis and minimal dehydration. The approach to nausea and vomiting in children from UptoDate states reasons to admit would include signs of significant dehydration poorly responsive to intravenous hydration in the Emergency Department, hemodynamic instability, significant electrolyte imbalance, demonstrated oral hydration intolerance to oral challenge, poorly controlled pain with an oral pain medication regimen, concerning physical exam findings for a surgical process or findings consistent with significant blood loss or bowel obstruction. He did not meet any of these criteria. He received < 10cc per kilogram of saline and was observed for less than 2 hours before he was admitted. After limited resuscitation in the ED his vomiting resolved and he tolerated oral hydration. 

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

The patient presented with chief complaints of fever, cough and poor appetite. The patient presented with history of fever up to 102 for the past four days along with cold and cough. Parents were giving Motrin for fever, but it would not go down and continued to return. The patient was taken to an outside emergency room and discharged with diagnosis of viral syndrome. Mother states that no tests were done there. The patient continued to have fever and poor appetite as well as decreased activity so he was brought to accepting hospital where evaluations revealed influenza A and Chest x-ray was questionable for pneumonia as perihilar opacity was present. The patient was admitted to the pediatric floor. The patient was given an intravenous (IV) fluid bolus and started on Tamiflu, IV fluids, and Ceftriaxone. As per the parents, the child was on the fifth day of fever. There was some discharge from the child's right eye with red conjunctiva and puffiness. Lips were erythematous and swollen. The patient had no rash, no hands or feet swelling, no other findings. There was some concern for a Kawasaki disease. The patient is fully vaccinated. The patient was admitted. 

The health plan's determination is upheld. The inpatient stay was not medically necessary. The patient was admitted with influenza A and chest XR with perihilar opacity. The patient was not in respiratory distress, had no documented hypoxia or need for supplemental O2, no tachypnea, no clinical signs of dehydration and his vital signs were stable apart from high fever for the first 6 hours while on the floor. The patient had an uneventful course in which he was administered oral Tamiflu, Oral Zyrtec, IVF, EES eye ointment and IV Ceftriaxone. The patient did not require any intensive monitoring, highly skilled or technical services or high level of care. There was some concern for Kawasaki disease but no work up was ever done and child defervesced very quickly after admission. This child could have safely been discharged with close follow up in 24 hours after a period of observation. For these reasons Inpatient admission was not warranted nor medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest pain
Treatment: Inpatient admission
The inpatient admission was not medically necessary.

This patient presented for evaluation of chest pain. The diagnosis of an acute MI (myocardial infarction) was ruled out by cardiac enzymes, which were negative, and the patient was referred for a stress test. Ischemia was ruled out by stress testing. There was no evidence of acute myocardial infarction, ACS, decompensated CHF (congestive heart failure), malignant arrhythmia or hemodynamic instability. 

The standard of care for patients presenting with chest discomfort, and in whom the diagnosis of acute coronary syndrome is unclear, is observation in the ED or chest pain unit with serial cardiomarker measurements to rule out an acute myocardial infarction, followed by a non-invasive ischemic workup (stress test, CT angiogram). This standard of care is in concert with American College of Cardiology (ACC) / American Heart Association (AHA) clinical guidelines. Therefore, the clinical information provided in the record submitted for review does not support medical necessity for this admission, and the care required could have been provided at a lower level of care.
Appeal type: Formulary Exception
Decision: Overturned in Part

Diagnosis: Female infertility
Treatment: Formulary exception for Gonal-F Menopur, Ganirelix, HCG and Leuprolide

The health plan should cover the Formulary Exception for Gonal-F Menopur, Ganirelix, HCG and Leuprolide, in part.

Specifically, the health plan should cover the Formulary exception for Gonal-F, Menopur, HCG, and leuprolide, but not for ganirelix.

The patient is a female undergoing IVF (in vitro fertilization) for oocyte cryopreservation.

In review of the current literature, the use of GnRH (leuprolide) in the setting of IVF is well established for its use of controlled ovarian stimulation and triggering of ovulation.  The use of Gonal-F and Menopur are also well established as stimulants to follicular growth.  HCG is also a known and established ovulation trigger. Therefore these medications are medically necessary as supported by current medical literature, since they are accepted standards of medical practice.  

There is no evidence that Ganirelix, a GnRH antagonist, is needed over the GnRH agonist in the records provided.  Therefore, this is not medically necessary at this time.

The medications except for Ganirelix are well established in the literature as a protocol for in vitro fertilization.

The health plan's denial rationale indicates that they do "not allow coverage of Gonal-F, Menopur, Ganirelix, hCG and leuprolide acetate unless the patient is undergoing ovulation induction."  As this patient is undergoing IVF, the health plan should cover the Formulary exception for Gonal-F, Menopur, HCG, and leuprolide, but not for ganirelix.
Appeal type: Medical necessity
Decision: Upheld

The patient is a female with a concomitant diagnosis of psoriasis and ulcerative colitis. The patient's colitis has been treated with steroids as well as anti-tumor necrosis factor (TNF) drugs. On anti-TNF therapy she developed psoriasis. She was started on Stelara 90 milligrams (mg) every (Q) 8 weeks in 2018 in essence to treat both diseases and has had a significant clinical response in skin and gastrointestinal (GI) symptoms. 

The patient's provider has recommended Stelara 90 mg Q 8 weeks. This request was denied by the plan. The denial is based on the fact that, based on her weight, the appropriate dose is 45 mg Q 12 weeks, this is the psoriasis dosing. It is experimental/investigational for the treatment of ulcerative colitis.

The health plan's determination is upheld.

No, the requested dose of Stelara 90mg every 8 weeks is not medically necessary for this patient. This patient has a concomitant diagnosis of psoriasis and ulcerative colitis. Although she has had a significant clinical response in skin and gastrointestinal (GI) symptoms, the use of Stelara for the treatment of ulcerative colitis is experimental/ investigational, and not the standard of care. It is only approved in Crohn's disease. There is a lack of evidence to support the use of Stelara at the Crohn's dose for the treatment of ulcerative colitis.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Knee pain, chondromalacia
 
Treatment: Synvisc One injections

The insurer denied Synvisc One injections. The denial was upheld.

This is a female with bilateral knee pain. She had received physical therapy (PT) over the years and has taken medications. Imaging reported chondromalacia. She received injections of Synvisc One in the past and is requesting additional injections to both knees. 

A review of the Clinical Practice Guideline by American Academy of Orthopedic Surgeons (AAOS) cites the 2013 Osteoarthritis (OA) knee treatment Clinical Practice Guideline (CPG) that contains one significant recommendation change from the 2008 CPG with regard to the issue of viscosupplementation. The 2008 OA knee CPG included an "inconclusive" recommendation regarding use of intra-articular hyaluronic acid (HA) injections that was largely the motivating factor for the expedited update of the CPG. The second edition CPG recommendation reads "We cannot recommend using hyaluronic acid (HA) for patients with symptomatic OA of the knee," with a "Strong" rating, based on supporting evidence from 3 high-quality and 11 moderate-quality research studies that met the inclusion criteria.

The CPG's best evidence synthesis does not support the efficacy of viscosupplementation. Although statistically significant outcomes were seen in some studies with higher molecular weight HA preparations, these outcomes were not clinically significant, based on a lack of minimum clinically important improvement (MCII). (For more information on MCII, see "The Importance of Clinical Significance in AAOS CPGs," AAOS Now, May 2013.) The Orthopedic group reports "strongly do not recommend use."

Based on the above, the medical necessity for bilateral knee Synvisc One Injections is not substantiated.  The insurer's denial is upheld.