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

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

The patient is a man with a history of hypertension, dyslipidemia, and carotid endarterectomy who presented to the hospital. He presented with a chief complaint of hypertension. He reported that he had seen his primary care physician three weeks prior to presentation. At that time, his blood pressure was reportedly normal. He was seeing his vascular surgeon for a left leg angiogram for work up of claudication, and he was found to have a systolic blood pressure of 260. He did report headache but denied blurry vision or weakness. Vital signs showed blood pressure 223/76, Temperature 97.6 Fahrenheit, respiratory rate 16, and heart rate 47. On physical exam, heart was regular, breath sounds were normal, and the abdomen was soft and nontender. There was no cranial nerve deficit and the optic disc could not be evaluated bilaterally due to cataracts. An electrocardiogram (EKG) showed sinus bradycardia with no evidence of ischemia. Head computed tomography (CT) was negative for acute stroke. Labs showed white blood cell (WBC) 6.9, hemoglobin 12.7, creatinine 1.1, sodium 138, and troponin negative. A CT angiography of the neck demonstrated stenosis greater than 50% at the origin of the vertebral arteries. Chest x-ray was negative for pneumonia. The patient was admitted with hypertensive urgency. The plan of care included monitor blood pressure, resume amlodipine, hydralazine as needed, neurology consult, restart Plavix and aspirin, echocardiogram, brain magnetic resonance imaging (MRI), and hold home beta blocker. 

The inpatient stay was not medically necessary. Because of the absence of hypertensive emergency, hemodynamic instability, acute stroke, or subarachnoid hemorrhage, the patient could have been managed at a lower level of care. Hypertensive urgency is normally managed at a lower level of care, and, while this patient did need further evaluation due to his extensive history of peripheral vascular disease and the renal artery stenosis that was identified on imaging, this evaluation does not need to happen at the inpatient level of care because it is primarily diagnostic.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Sickle cell anemia, multifocal pain
Treatment: Inpatient admission
The insurer denied the inpatient admission. 
The denial is upheld. 

The patient in this case is a female who has a history of sickle cell anemia.  She presented to the emergency department with multifocal pain.  The pain involved her back, left wrist and right wrist and other joints.  She had a known history of rheumatoid arthritis along with sickle cell disease.  She noted that pain had been gradually worsening.  No other symptoms were noted.  She had been found to have anemia with a hemoglobin of 5.6 grams per deciliter (g/dl) prior to presentation and also had been taking oral hydromorphone without any significant improvement in her pain.  

Vital signs on admission were unremarkable.  The patient was diagnosed with sickle cell pain crisis and also with rheumatoid arthritis flare.  She was seen by rheumatology and was noted to have elevated inflammatory markers and also to have synovitis on exam.  She was treated with blood transfusion and intravenous Dilaudid.  She was also started on prednisone.  Hemoglobin rose to the 7-8 grams per deciliter (g/dl) and remained stable.  There was mild elevation in creatinine at the time of admission, which improved.  Pain improved during the course of her admission after she started prednisone.

No, the proposed inpatient admission was not medically necessary.

This patient has both sickle cell disease and rheumatoid arthritis.  She had active rheumatoid arthritis and was noted after admission to have elevated inflammatory markers and and synovitis on examination.  She improved promptly after starting prednisone.  She did not clearly have a sickle cell crisis as this would not have caused her multifocal joint pain, elevated inflammatory markers and synovitis.  Given that she only required treatment with oral prednisone and pain improved promptly after starting that treatment, she did not require acute care hospitalization for this issue.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Stelara. 
The denial is overturned.

The patient is a male with Crohn's Disease. He was diagnosed with ileitis. He has a history of perianal fistulous disease. He had an ileal stricture and underwent ileocolonic resection. Subsequently he had an anastomotic stricture dilated. The patient has already tried and failed multiple therapies including infliximab. He was previously on Entyvio but developed recurrent symptoms of abdominal pain. Due to obstructive symptoms, the patient was placed on prednisone. The patient's provider had recommended Stelara for further management. This request was denied by the plan - the preferred plan alternative is Humira. The subject under review is the medical necessity for Stelara in this case.

The health plan's determination of medical necessity is overturned.

Yes, Stelara is medically necessary for this patient. While it is not made clear why he failed infliximab previously (e.g., did he develop antibodies? Was it a mechanistic failure?), the guidelines are fairly consistent - when a patient fails one anti-tumor necrosis factor (TNF) agent there is often little value to trialing another medication in the same class. It usually turns out to be a class failure. [1] New information is demonstrating that certain human leukocyte antigen (HLA) haplotypes may be at the origin of this class failure. The patient is potentially heading toward another operation. The only reasonable choice in this specific case is ustekinumab (Stelara) as he recently failed vedolizumab.
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. 

This is a woman who was referred to the emergency department by her cardiologist for evaluation of chest pain and exertional dyspnea. She had just been discharged from a different hospital one or two days prior after admission for the same symptoms. An echocardiogram showed a normal left ventricular ejection fraction. Due to persistent symptoms she was advised to go to the emergency department (ED). Her past medical history was remarkable for diabetes, hypertension and hyperlipidemia. In the emergency department (ED) she was not having chest pain. Her blood pressure was 190/61 mmHg with a heart rate of 92 beats/minute. Her room air oxygen saturation was 100%. Her physical exam was unremarkable. An electrocardiogram showed sinus rhythm with nonspecific T wave abnormalities. Her serum troponin level was normal. The patient was admitted to the hospital for evaluation for possible acute coronary syndrome. 

The Inpatient Hospital Admission was not medically necessary for this patient. 
This woman, with multiple cardiac risk factors, presented with atypical symptoms that were thought to possibly represent acute coronary syndrome (ACS). She was pain-free at the time of presentation. She was hemodynamically stable, with normal cardiac biomarkers, and no ischemic electrocardiographic changes. She 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 under "ambulatory" or "observation" status. This approach has been shown to be both safe and effective and is in accordance with the 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

Diagnosis: Digestive System/Gastrointestinal.
Treatment: Inpatient Hospital. 
The insurer denied inpatient hospital admission for medical necessity. 
The denial was upheld.

The patient is a previously healthy female who presented to the hospital emergency department (ED) with right upper abdominal pain, nausea and vomiting. She had a past medical history of a recent pregnancy during which the pain episodes began. She was tender in the right upper abdomen. At the time of presentation, the patient was without fever and her vital signs were normal. The white blood cell (WBC) count was normal at 5.8 K. The complete metabolic panel identified elevated transaminases and bilirubin. A computed tomography (CT) scan and abdominal ultrasound confirmed the diagnosis of cholelithiasis. A magnetic resonance cholangiopancreatography (MRCP)  showed a mildly dilated common bile duct (CBD) of 7.5 millimeter (mm), but no common bile duct stones.
She was initially treated with intravenous (IV) fluid and IV antibiotics. The patient was reported to be comfortable and had normal vital signs. Her liver enzymes were improved. The patient underwent an endoscopic ultrasound (EUS). This study did not identify CBD stones. She was started on a diet following the procedure. The patient was considered to be stable for discharge home with arrangements for outpatient surgical follow up.
At issue is the medical necessity of the inpatient level of care stay.
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.
This patient is a female who presented to the hospital with cholelithiasis/biliary colic and elevated liver enzymes and bilirubin. Imaging with ultrasound, CT scan, MRCP and laboratory data established the indication for cholecystectomy. The patient underwent an endoscopic ultrasound. Her post-procedure course was uncomplicated. Her diet was advanced, and her vital signs remained normal. Her pain was well controlled. The patient was given post discharge instructions for surgical follow up. In this case, the submitted documentation does not support that there was severe systemic infection, a need to care for active comorbidities, or complications of the procedure to warrant an inpatient level of care.
Therefore, the inpatient level of care was not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest pressure.
Treatment: Inpatient admission.
The insurer denied the inpatient admission.
The denial is upheld. 

The patient is a male. He was admitted for an elective catheterization and PCI (percutaneous coronary intervention).

The patient had symptoms of atypical chest pressure and dyspnea on exertion, and a positive stress test. Uncomplicated right radial procedure revealed a 90% circumflex lesion. He underwent successful uncomplicated PCI with stenting. He was hemodynamically stable. He had no post-catheterization issues. He was discharged on optimal medical therapy.

No, the Inpatient admission was not medically necessary.

This was an elective, uncomplicated catheterization and PCI that was scheduled. The patient was always hemodynamically stable with normal vital signs, normal EKG (electrocardiogram), normal LV (left ventricle) function, and no ectopy. The only care that was given after the uncomplicated radial catheterization was monitoring, IVF (intravenous fluids), and routine medications. This meets definition of outpatient care without any indication for a higher level of care.

Many institutions' protocols include a same day discharge. CMS (Centers for Medicare and Medicaid Services), RAC (recovery audit contractor) surveys, the proposed 2-midnight rule, and all guidelines specify this as an outpatient procedure for an uncomplicated PCI.

Radial catheterization was developed with one of its advantages being the safety in early ambulation and discharge. The overnight stay for observation and telemetry does not change that determination. While possible, bleeding post radial artery intervention is rarely seen, and it does not require extended monitoring.

The letter of appeal was carefully considered, but it offered no evidence to support a higher level of care. The only care that was provided was telemetry, which is frequently performed in observation and outpatient status. The patient was admitted for monitoring and routine post-catheterization care, neither of which required an inpatient level of care. There was no "complex" care that was required in this patient's care post-catheterization. While there was always a potential for an adverse event, one did not happen, and no actual treatment was needed.

The appeal letter referenced Milliman Care Guidelines. Milliman criteria requirements for ACS (acute coronary syndrome) do not apply, as the patient did not meet criteria to support that diagnosis. It is incorrect to label the presentation of this case as unstable angina, as the patient was pain-free. EKG showed no changes and no acute medical treatment was given for ACS.

All of the testing and therapy that were provided would have been appropriate, safe and guidelines-consistent to be in an outpatient setting. Thus, inpatient level of care was not medically necessary.

The denial was consistent with guidelines and usual community care. Post cardiac care as described is routinely performed at a lower level of care. Included in the references are articles supporting same-day discharge as safe and appropriate.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Epigastric abdominal pain.
Treatment:  Inpatient admission.

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

This patient is a female with a history including alcohol abuse, fibromyalgia and hypertension (HTN) who presented to the emergency department (ED) with epigastric abdominal pain radiating to back.  The patient had begun drinking again.  

In the emergency department, the patient was found to have hypotension, alcohol level 0.21, and creatinine (Cr) 1.4.  The patient was a admitted with suspected gastritis/duodenitis secondary to alcohol use and hypovolemic hypertension.  Plan of care included intravenous fluids (IVF) and proton pump inhibitor (PPI). Vital signs revealed the following:  temperature 98.4, heart rate 87, respiratory rate 18, blood pressure 164/90, and oxygen saturation  95%.  The patient felt better; abdominal pain was improved.  The patient was to continue the proton pump inhibitor (PPI).  Blood pressure was rising now; the patient was to resume antihypertensives.  Acute kidney injury (AKI) resolved.  The patient was on a Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol.  She did not require Ativan.  

The following day, vital signs were stable (VSS).  The patient was tolerating food and requesting to go home.  She was cleared for discharge.

No, the proposed inpatient admission was not medically necessary.

This patient with a history of alcohol abuse was admitted after presenting with abdominal pain and alcohol intoxication.  She was treated with intravenous fluids (IVF) and proton pump inhibitor (PPI).  The patient was hemodynamically stable and pain was resolving.  Hypotension and renal insufficiency had resolved with fluid replacement.  She was tolerating oral (PO) intake.  The patient did not have signs of alcohol withdrawal or altered mental status.  The patient was clinically stable.  She continued to receive proton pump inhibitor (PPI).  She was not receiving care that required an ongoing acute inpatient level of care.  

Medically necessary services are those which are:  1) safe, 2) effective, 3) generally accepted national standard of medical practice, 4) not provided primarily for convenience of the patient or the practitioner, and 5) the least intensive and/or most appropriate alternatives among diagnostic and treatment option.

The requested inpatient admission from was not medically necessary because it was not in accordance with generally accepted national standard of medical practice for this patient's scenario.

The patient could have been safely and effectively treated at a lesser level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Epidermal growth factor receptor mutated non-small cell lung cancer.

Treatment: Genetic Testing Guardant 360.

The insurer denied coverage for Genetic Testing Guardant 360.

The denial is upheld. 

This is a female patient with known epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC), treated initially with Tagrisso. She progressed and attending provider performed Guardant 360 testing.

There is no evidence to support the use of Guardant 360 testing in the evaluation of a patient with known anaplastic lymphoma kinase (ALK) mutated non-small cell lung cancer (NSCLC). While the National Comprehensive Cancer Network (NCCN) supports this testing as part of the initial molecular testing for NSCLC, no such recommendation is made for patients with established ALK mutations who progress on Tyrosine kinase inhibitors (TKIs) therapy.  

According to Le Tourneau, C., et al (2015), "The use of molecularly targeted agents outside their indications does not improve progression-free survival compared with treatment at physician's choice in heavily pretreated patients with cancer. Off-label use of molecularly targeted agents should be discouraged, but enrolment in clinical trials should be encouraged to assess predictive biomarkers of efficacy."

According to Singh, A.P., et al (2020), "While recognizing that a 10% overall rate of management change that is based on CGP [comprehensive genomic profiling] is very modest, its use in certain subsets, such as advanced NSCLC, where the impact currently is most significant appears to be justifiable and it has been found to be cost effective. In addition, we have identified multiple reasons for the relatively smaller clinical impact of CGP in other tumor types, despite a much larger proportion of patients with actionable genomic alterations reported. The impact however is anticipated to be increasing in light of new advances, e.g., recent studies do suggest expanding impact in breast (PI3 kinase inhibitors) and pancreatic malignancies... Although issues, such as optimal timing, access to clinical trials, and consolidating genomic testing need to be addressed at an institutional level, reports from testing platforms need to be carefully interpreted and ideally discussed in molecular tumor boards to provide the best treatment option possible. More prospective trials are needed that would better inform our choices for personalized treatment by providing assessments of overall survival and quality of life with choosing targeted therapies that are based on CGP when compared to conventional therapies."

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

The medical necessity for Genetic Testing Guardant 360 is not substantiated. The insurer's denial is upheld
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis Crohn's Disease
Treatment: Stelara 90 mg/mL Syringe, 90 mg every 6 weeks
The insurer denied the Stelara 90 mg/mL Syringe, 90 mg every 6 weeks.
The determination is overturned.

The patient was diagnosed with Crohn's disease. He failed azathioprine, and then weekly Humira (with a colonoscopy showing severely active ileitis with ulceration). He started Stelara with improvement. He has had loose bowel movements 1-2 weeks prior to Stelara injections. His Stelara level was low at 2.5 micrograms per milliliter (ug/mL). At issue is whether  Stelara 90 milligrams (mg) every 6 weeks for the treatment of Crohn's disease is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease .
The request for dose escalation of Stelara to 90 mg every 6 weeks in this case is supported by current medical literature. Stelara is Food and Drug Administration (FDA) -approved for the treatment of Crohn's disease, and a large randomized controlled trial demonstrated safety and efficacy of Stelara for induction and maintenance of remission in patients with moderate-severe Crohn's Disease that was resistant to anti-tumor necrosis factor (TNF) therapy, as this patient has [1-3]. Guidelines for the treatment of Crohn's disease recommend the use of Stelara [4].
In this case, the patient has moderate to severe disease based on a diagnosis at an age below 30. A recent study demonstrated that a significant majority of patients who have failed an anti-TNF medication achieve and maintain response with Stelara [4]. A study showed dosing intensification (90 mg every 4 weeks) was used frequently to address loss of response, and a large proportion of patients were able to maintain response [5-7]. One study showed that dose escalation was required and approximately half of patients, and successful in 61.1% of dose escalation attempts [5]. Another study showed efficacy of dose escalation to recover lost response in 73% of patients in whom it was attempted [7]. Additionally, the American College of Gastroenterology guidelines for the treatment of Crohn's disease state that "Those with continued symptoms should be treated with an alternative therapy for mild to moderate disease, have their medication dose adjusted in order to attempt to optimize therapy" [4]. In this case, the patient has failed azathioprine, Humira, and now Stelara every 8 weeks; continuation of dosing every 8 weeks may result in complications such as fistula, stricture, bowel obstruction, flare, hospitalization, need for surgery, or other complications in this patient with severe disease proven on colonoscopy and a low Stelara level. For all of these reasons, Stelara 90 mg every 6 weeks is supported as likely to be more beneficial than any standard treatment for the treatment of Crohn's disease in this case.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis Crohn's Disease
Treatment: Stelara 90 mg/mL Syringe, 90 mg every 6 weeks
The insurer denied the Stelara 90 mg/mL Syringe, 90 mg every 6 weeks.
The determination is upheld.

The patient has Crohn's disease. He has primarily ileitis last documented on colonoscopy. He was maintained on Humira for many years. Last year the patient was started on Stelara (ustekinumab). He is also on Lialda. The patient is on an every 8 week regimen, however, he develops breakthrough symptoms after 6-7 weeks. This consists of an increase in his normal bowel movement (BM) frequency of 2-3 per day. A trough ustekinumab level was checked and the patient had a level of only 2.5 without the presence of antibodies which is considered below the optimal level of 4.5 micrograms per milliliter (ug/ml).
The patient's provider has requested Stelara 90 milligrams (mg) every (Q) 6 weeks. This request was denied by the health plan and at issue is whether the Stelara 90 mg/mL Syringe, 90 mg every 6 weeks is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
There currently is inadequate data to determine whether dose escalation of Stelara during the maintenance phase beyond 90 mg Q 8 weeks is beneficial.
The data on dose escalation has thus far been derived from retrospective multicenter data registries.[2,3] Prospective data, whereby dose escalation is performed based on a priori criteria have not been collected to date. Further, there is inadequate data to confirm that the optimum trough level of the drug is 4.5 ug/ml.[1]
It is not clear that dose escalation to 90 mg Q 6 weeks is likely to be more beneficial than continuing on a Q 8 week maintenance schedule.