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

Diagnosis:  Pulmonary Embolism
Treatment: Inpatient Hospital Stay
The insurer denied the Inpatient Hospital Stay.
The determination is upheld.

The patient presented to the emergency department with right flank pain worse with deep breathing. On presentation, she was afebrile with a heart rate of 71, blood pressure 113/66, respiratory rate 18, and an oxygen saturation of 98% on room air. Labs resulted with a white blood cell count (WBC) of 6.89, Hemoglobin (HGB) 12.6, platelets 170, sodium 136, potassium 4.4, blood urea nitrogen (BUN) 24, creatinine 0.6, and troponin undetectable. A computed tomography (CT) angiogram of the chest revealed acute segmental and subsegmental pulmonary emboli with infarction and pleural effusion with no evidence of right heart strain. An electrocardiogram (EKG) showed no evidence of acute ischemia, arrhythmia or heart strain. The patient was subsequently brought into the hospital with concerns for a pulmonary embolism and plans for Lovenox, obtaining a duplex lower extremity ultrasound to rule out deep vein thrombosis, and performing a hypercoagulability work-up in 4-5 weeks.
She was hemodynamically stable without a fever, hypotension, tachycardia, or hypoxia. The plan was to switch to Lovenox, and a follow up doppler ultrasound and echocardiogram. The echocardiogram showed no evidence of right heart strain. The patient was discharged. The issue for review is whether care at the inpatient level of care was medically necessary.

The inpatient stay was not medically necessary. This is a young patient on oral contraceptives without medical problems who presented with right flank pain and was diagnosed with a pulmonary embolism with pulmonary infarction. She was hemodynamically stable on presentation without tachycardia, hypotension, or hypoxia, and did not have evidence of cardiac arrhythmia or heart strain based on cardiac markers, electrocardiogram (EKG), and imaging, and did not have pain requiring frequent doses of intravenous (IV) pain medications. She also did not have a history of bleeding or renal failure complicating her ability to be on anticoagulation. Given this, and that pulmonary embolism being a diagnosis can frequently being treated in the outpatient setting, it is unclear why she was unsafe to treat at a lower level of care. 
In the absence of hemodynamic instability, hypoxia, right heart strain, need for thrombolysis, history of bleeding or renal failure precluding easy initiation of oral anticoagulation or lovenox, or pain requiring frequent repeated doses of IV pain medications, inpatient care was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Orthopedic / Musculoskeletal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied: Prolia. 
The denial was upheld in whole. 

The patient is a female with past medical history of Crohn's disease with chronic steroid use, chronic pain and osteoporosis. The patient had a dual-energy X-ray absorptiometry (DEXA) scan showing T-score of -3.1 at the spine and lowest reading at the hip of -2.6. The patient's primary care physician (PCP) prescribed Prolia injection for treatment of osteoporosis. The subject under review is the medical necessity for Prolia.

The health plan's determination is upheld in whole. 

No, Prolia injection is not medically necessary. The patient has not had a trial, failure or contraindication to injectable bisphosphonate. The patient's provider cited concern over gastrointestinal (GI) side effects with bisphosphonate therapy as the reason to prescribe Prolia. The patient is at high risk for GI intolerance to oral bisphosphonate due to Crohn's disease and therefore contraindicated, however the patient is a candidate for injectable bisphosphonate therapy. Although an oral bisphosphonate could cause GI side effects an injectable bisphosphonate is not likely to. If GI intolerance of oral bisphosphonate trial, failure or contraindication to injectable bisphosphonate will be required in order to cover Prolia injection. There is no documentation of a trial, failure or contraindication to injectable bisphosphonate. Prolia is not medically necessary unless the patient tries or fails injectable bisphosphonate.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Atopic dermatitis 
Treatment: Formulary exception for Dupixent 

The insurer denied the Formulary exception for Dupixent. The denial is overturned. 

Yes, the health plan should cover the formulary exception for Dupixent. 

The patient has severe atopic dermatitis affecting multiple areas of the body. He is a candidate for systemic therapy as the BSA is too large for reasonable control with topical medications. Topical calcineurin inhibitors (tacrolimus) are not appropriate therapy for severe, widespread atopic dermatitis, affecting sensitive areas, which should be treated with systemic therapy. 

Dupilumab is a monoclonal antibody that inhibits IL-4 and IL-13 signaling by blocking the shared IL-4Ra and originally demonstrated efficacy in phase II clinical trials. In 03/2017, it was approved by the US Food and Drug Administration (FDA) for adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It is a subcutaneous injection administered initially at a dose of 600 milligrams (MG) and then every two weeks thereafter. 

Given its unprecedented efficacy, dupilumab is emerging as a first-line therapeutic for moderate-to-severe AD. The patient has failed topical steroids, calcineurin inhibitors, and systemic steroids. Additionally, topical calcineurin inhibitors are not indicated for severe disease.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest Pain 
Treatment: Inpatient Hospital Stay 

The insurer denied the inpatient hospital stay. The determination is upheld. 

This patient with a history of coronary artery disease, myocardial infarction, hypertension and chronic obstructive pulmonary disease (COPD) presented to the emergency department via ambulance complaining of left-sided chest pain that was relieved by nitroglycerin and aspirin. His blood pressure was 106/68 millimeters of mercury (mmHg) with a heart rate of 65 beats/minute. His respiratory rate was 18/minute with a room air oxygen saturation of 98%. His cardiac exam was unremarkable. An electrocardiogram showed sinus bradycardia without ischemic changes. A chest x-ray showed no acute pathology. The patient's serum troponin and brain (or B-type) natriuretic peptide (BNP) levels were normal. He was admitted to the hospital to rule out acute coronary syndrome. An echocardiogram showed mild apical hypokinesis. Myocardial perfusion imaging showed no evidence of ischemia. The patient was discharged. At issue is the medical necessity of an inpatient. 

An inpatient level of care was not medically necessary. 

This patient, with known coronary artery disease, presented with symptoms that were thought to be suspicious for acute coronary syndrome (ACS). He was hemodynamically stable, with normal cardiac biomarkers, and no ischemic electrocardiographic changes. He did not require intensive monitoring or infusion of intravenous cardioactive medications. 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 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.
Appeal type: Medical necessity
Decision: Upheld

Substance Abuse/Addiction
Substance Abuse: Inpatient

Diagnosis: Substance Abuse
Treatment: Inpatient Rehabilitation Services 
The insurer denied Inpatient Rehabilitation Services. The health plan's determination is upheld. 

The patient is a male who transferred for inpatient rehabilitation substance use disorder treatment to address substance use disorder with stimulants (cocaine); alcohol; and opioids (heroin). The patient had no history of withdrawal seizures, delirium tremens or other episodes of severe withdrawal symptoms. He had a history of substance use disorder with multiple prior treatments with relapses including use of substances while receiving medication assisted treatment with Suboxone. He was using cocaine in large quantity with three grams per day; and, daily use of alcohol with up to three 40-ounce beers and three pints of vodka; and, opioids with up to 20 bags of heroin with intranasal (snorting) or intravenous (IV) administration. 

The inpatient rehabilitation admission services are not medically necessary for this patient.
The proposed inpatient treatment and other inpatient medical services noted in the clinical summary could have been safely and effectively provided at a lower level of care. The clinical features and indicated treatment dimensions of this patient's alcohol, stimulant and opioid use disorders, and co-occurring depressive disorder with insomnia, did not require or warrant the structure of an inpatient setting or 24-hour monitoring. The patient displayed no serious disturbance of mental status despite having a history of ongoing substance use disorder with multiple substances of abuse and ongoing outpatient treatment that included past treatment for an unspecified depressive disorder. Moreover, the patient had been evaluated and cleared with regard to safety concerns, and did not show evidence for suicidal or aggressive behavior or risk, or severe cognitive impairment or psychosis, or perceptual disturbance, or general medical complications that would have warranted an inpatient level admission and treatment. The patient was engaged in treatment and motivated to participate in treatment, especially in view of the psychosocial stressors present in this case.
Thus, the requested inpatient level services were not medically necessary in this case scenario. And, any indicated treatment for substance use disorder in this case could have been effectively provided with lower level care in a less restrictive treatment setting in keeping with American Society of Addiction Medicine (ASAM) Criteria and the NY State Office of Alcoholism and Substance Abuse Services (OASAS) LOCATDR (The Level of Care for Alcohol and Drug Treatment Referral) 3.0 Guidelines applicable in this case.
Appeal type: Medical necessity
Decision: Upheld

Cardiac
Inpatient hospital

Diagnosis: Chest pain
Treatment: Inpatient stay
The insurer denied the inpatient stay. The health plan's determination is upheld. 

The patient is a woman with morbid obesity, diabetes, gastroesophageal reflux disease (GERD) and recent onset of atrial fibrillation who presented to the emergency room (ER) with complaints of chest discomfort. She was admitted and ruled out for myocardial infarction, with serial negative troponins. Her chest symptoms seemed most consistent with GERD, as they occurred after eating or lying down. She was placed on high dose proton pump inhibitor (PPI), H2 blocker and Maalox. Symptoms improved. An abdominal ultrasound showed no cholelithiasis or biliary duct dilation. She was discharged.
Under review is the inpatient stay.

The inpatient hospitalization is not medically necessary. The patient presented with chest pain but was hemodynamically stable. She had no evidence for myocardial ischemia and had a recent negative cardiac catheterization. She was felt to have esophageal disease causing her symptoms. However, she does not meet criteria for inpatient admission for esophageal disease based on Milliman Criteria, as she did not have: hemodynamic instability, suspected esophageal perforation or fistula, esophageal obstruction, esophagitis with secondary mediastinitis, persistent vomiting, dehydration, severe electrolyte abnormalities, caustic ingestion-related esophageal injury, severe pain requiring acute inpatient management, inability to maintain oral hydration that persists after observation care treatment or need for inpatient surgery. A lower level of care would have been appropriate.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal 
Treatment: Surgical Services 

The insurer denied the TIF with EsophyX. The denial is upheld in whole. 

The patient is a male with gastroesophageal reflux disease (GERD) symptoms for 30 years. He has been on Dexilant and Carafate, with Pepcid at night; proton pump inhibitor therapy was only partially effective. He has had dysphagia requiring empiric esophageal dilation. Esophagogastroduodenoscopy showed mildly erythematous mucosa in the lower esophagus, non-erosive gastritis, and normal duodenum. Bravo pH study reported elevated DeMeester score consistent with reflux and 99.3% symptom correlation. Esophagogram showed no hiatal hernia, gastroesophageal reflux, or ulcer; there was spasm in the gastric antrum and proximal duodenal loop without ulceration. Esophageal manometry showed increased lower esophageal sphincter resting pressure but normal relaxation, normal esophageal peristalsis, and normal liquid and viscous transit. The subject under review is whether the transoral incisionless fundoplication with the EsophyX device is likely to be more beneficial for this patient. 

The health plan's determination is upheld in whole. 

The efficacy of transoral incisionless fundoplication (TIF) using the EsophyX device has been studied in randomized controlled trials (Sami, et al). However, the conclusions are contradictory: one large randomized trial including 60 patients found no improvement in esophageal acid exposure compared with baseline at 12 months; normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of proton pump inhibitors (PPIs) in 61% (Witteman, et al). The study concluded that no long-term objective reflux control was achieved. The 2013 American College of Gastroenterology guidelines for treatment of GERD report that "the usage of current endoscopic therapy or TIF cannot be recommended as an alternative to medical or traditional surgical therapy (moderate level of evidence)" (Katz, et al). A recent systematic review and meta-analysis concluded that "future controlled trials are needed to directly compare efficacy, long-term durability, and safety between TIF and Nissen fundoplication" (McCarty, et al). In 2013 the Society of American Gastrointestinal and Endoscopic Surgeons reported that numerous published series have reported significant adverse events and that there is a lack of sham-controlled trials comparing TIF with anti-reflux surgery; Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) concluded that "further studies are required to define optimal techniques and most appropriate patient selection criteria, and to further evaluate device and technique safety (Auyang, et al). These conclusions are bolstered by recent reports of severe adverse events during the procedure and the need for surgery to revise ineffective TIF (Ashfaq, et al; Bell, et al; Edress, et al). Therefore, the procedure is not likely to be more beneficial for this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal 
Treatment: Surgical Services 

The insurer denied the TIF with EsophyX. The denial is upheld in whole. 

The patient is a male under evaluation and management for gastroesophageal reflux disease (GERD). The patient has heartburn, regurgitation, and frequent belching. He has previously been treated with proton pump inhibitor (PPI) therapy and Carafate. The patient has had symptoms for 30 years. He has high resting tone of the lower esophageal sphincter (LES) and periodic dysphagia requiring occasional empiric dilations. No hiatal hernia. No Barrett's on esophagogastroduodenoscopy (EGD). A Bravo pH study confirmed frequent symptomatic reflux episodes. 

The patient's provider has recommended the transoral incisionless fundoplication (TIF) procedure. The subject under review is whether the procedure is likely to be more beneficial for the patient than standard treatment. 

The health plan's determination is upheld in whole. 

No, the TIF procedure is not likely to be more beneficial for this patient. TIF can be performed in patients with typical GERD symptoms, and no or only low-grade erosive esophagitis, and no or only small hiatal hernia ( less than or equal to [<=] 2 centimeter [cm]). This specific patient meets those criteria. TIF is contraindicated in patients with high-grade erosive esophagitis, Barrett's esophagus, atypical and extraesophageal symptoms of GERD, scleroderma, or other esophageal pathology or surgery which this patient does not have [1].

TIF has been compared with PPI therapy in several randomized trials [2]. In the latest trial (TEMPO), 63 patients with GERD refractory to PPI received TIF versus maximum standard dose PPI therapy [3]. At 6 months, both regurgitation and extraesophageal symptoms were eliminated in more TIF than PPI patients (62 versus 5%); 90 percent of TIF patients were off PPIs. After six months, all patients in the PPI group elected to cross over to TIF. At 3 years, 90 and 88% of patients reported elimination of troublesome regurgitation and all atypical symptoms, respectively [4]. At five years, troublesome regurgitation was eliminated in 80%, however 34% were back on a daily PPI. 

Although TIF is associated with fewer postoperative adverse effects such as gas bloating and dysphagia compared with surgical fundoplication [5], the durability of TIF is far less certain than that of surgery. In a meta-analysis of five randomized trials and 13 prospective studies, PPI use after TIF increased over time and the satisfaction rate was 69% at six months [6]. This reviewer agrees that TIF remains experimental/investigational at this time.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Diabetes Mellitus

Treatment: Inpatient admission

The insurer denied the inpatient admission.

The denial was overturned.

This is a male patient with a history of obesity and asthma who presented to the Emergency Room (ER) for concerns of new onset diabetes. The patient's hemoglobin A1c was found to be 11.5%, and the patient's bicarbonate and glucose were 22 and 282. The patient had symptoms of polyuria, polydipsia, and nocturia. The patient also experienced weight loss. In the ER, the patient's glucose was 466. He also had glucose and ketones in his urinalysis. Endocrinology was consulted. The patient received normal saline and was started on insulin using Lantus and short-acting insulin. The patient was admitted for new onset diabetes education, and as inpatient, the patient received all components of education.

Diabetes education consists of several components, nutritional counseling, self-monitoring of blood glucose and treatment of hyper and hypoglycemia. The standard of care is that all patients with diabetes should receive all these components  [1, [2]. Practice patterns differ depending on the availability of educators etc. Whether a patient gets hospitalized for intensive insulin therapy initiation depends on the available program where the patient is seen.

The majority (75%) of medical centers in the US [3] that treat new onset type 1 diabetes admit their patients. According to the ADA statement on treatment of type 1 diabetes [4], hospitalization is necessary regardless of severity if, "the center is not experienced in the outpatient management of newly diagnosed children with diabetes or is not adequately staffed to provide outpatient care because regional health care reimbursement is inadequate for initial outpatient care and education."    In type 1 diabetes, the initial hospitalization is to educate the patient and the family in self-injection, drawing up and mixing of insulins, checking blood sugar, recognizing and responding to hyper and hypoglycemia, and evaluating ketosis, as well as nutrition education on carbohydrate counting because there is only one treatment option (insulin). Learning these skills is an overwhelming task for most patients and families and is the reason that this is done with a several day admission to the hospital [5, [6, [7, [8]. 

In this case, the patient is a pediatric age with new onset diabetes requiring insulin initiation and complete diabetes education. The requested hospitalization for new onset diabetes education is consistent with generally accepted standards of medical practice and is therefore, 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 inpatient admission is substantiated.  The insurer's denial is overturned.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic migraines
Treatment: Ajovy 225MG/1.5ML
The insurer denied the Ajovy 225MG/1.5ML.
The denial is upheld. 

The member is a female with migraine headache disorder.  She has been treated with verapamil for preventive therapy.

No. The requested Ajovy is not medically necessary. 

There is no documentation to support the patient has tried and failed three first line oral migraine preventive agents. Moreover, the documentation provided in the form of a headache diary does not support the use of preventive agents, such as Ajovy, as the frequency of headache is about one per month. Finally, there is no documented trial of any oral abortive agent migraine. The diary documented sleep and ice and the acute treatment modalities. There is no reason, given the frequency of her headaches, that she cannot be treated with standard of care abortive agents rather than Ajovy.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Status post thyroidectomy with left TE groove dissection

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission. The denial is overturned.

This patient is a male with a diagnosis of papillary thyroid cancer.  The documentation did indicate the patient began having issues a couple of years ago with ongoing difficulty swallowing and singing.  The documentation indicated the patient was admitted for a total thyroidectomy with left TE groove dissection.  The documentation detailed the patient did not have any significant complication during surgical intervention.  The patient was noted to be frequently drowsy however, he was arousable to stimuli.  The documentation indicated the following day the patient was evaluated, and he felt food/thickened liquids were pooling.  His voice was mildly weak with a moderately strong cough.  Treatment options were discussed, and it was recommended the patient would benefit from a temporary injection augmentation.  The patient would likely need a permanent medialization laryngoplasty.  It was recommended to continue with thick liquids under observation due to the risk of aspiration.  He can progress to thick liquids and normal solids as tolerated.

On a specified date the patient was evaluated where it was noted the pain was controlled.  The patient was tolerating a regular diet and thin liquids.  The physical examination did not reveal any significant abnormalities.  There was dysphonia with one drain present.  The recommendation was made to continue with a regular diet.  The speech evaluation and teaching was pending. The patient was discharged as he continued to improve.  The patient was doing well, and an oral trial of thin liquids was observed.  There was reduced but adequate laryngeal elevation.  The patient was discharged with recommendation to follow-up.

It was medically necessary for this patient to be admitted post-operatively for several reasons: pain control after major head and neck surgery, observation for aspiration after sacrifice of the left recurrent laryngeal nerve, and for management of the patient's dysphasia and dysphonia.  For these reasons, the patient needed to be managed in the hospital setting during the initial post-operative period for his own safety and comfort.  
The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The carrier's denial of coverage for inpatient admission is overturned.  The medical necessity is substantiated.