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

Diagnosis: Crohn's Disease
Treatment: Simponi 100 milligrams/milliliter (mg/ml) syringe
The insurer denied Simponi 100 mg/ml syringe.
The denial is overturned.

The patient is a male with Crohn's disease with two small bowel resections and a colon resection and diverting colostomy due to perianal disease. He has failed Stelara, Humira, and budesonide. He started Simponi with good response, but has had breakthrough symptoms including pain. His Simponi level was low at 0.6 micrograms per milliliter (ug/mL) and lack of anti-Simponi antibodies. The requested coverage is for Simponi re-induction (200 milligrams [mg] at week 0, 100 mg at week 2) and then 100 mg subcutaneously every two weeks) for the treatment of Crohn's disease.

The request for Simponi therapy is supported as likely to be more beneficial than any standard treatment or treatments for the patient's Crohn's disease. The patient previously had maintenance of remission on Simponi, and now has loss of remission in the setting of low Simponi level (without anti-Simponi antibodies). American College of Gastroenterology guidelines for the treatment of Crohn's disease state that "Those with continued symptoms should... have their medication dose adjusted in order to attempt to optimize therapy" [1]. An increase in dose can result in regain of remission, as studies have shown that the Simponi level in this case is not sufficient for maintenance of remission [2]. Although not Food and Drug Administration (FDA)-approved for the treatment of Crohn's disease, Simponi is an anti-tumor necrosis factor medication with the same mechanism of action as Remicade, Humira, and Cimzia, which are approved for the treatment of Crohn's disease [1]. Additionally, multiple studies have shown long-term efficacy of Simponi in the treatment of Crohn's disease [3-7]. Given the nearly undetectable Simponi drug level, re-induction is appropriate, as induction is used when initiating therapy; subsequent dose escalation is also appropriate, as use of the prior dose could result in an undetectable drug level again. American Gastroenterological Association guidelines support this course of action, stating that when there is a low or undetectable drug level and lack of anti-drug antibodies (as in this case), the recommendation is to "increase drug dose" rather than switching medications within the drug class or to another drug class [8]. For these reasons, the request for re-induction and dose escalation of Simponi (200 mg at week 0, 100 mg at week 2) and then 100 mg subcutaneously every two weeks is supported as likely to be more beneficial than any standard treatment or treatments for the patient's Crohn's disease.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Crohn's Disease
Treatment: Simponi 100 milligrams/milliliter (mg/ml) syringe
The insurer denied Simponi 100 mg/ml syringe.
The denial is upheld.

The patient is a male with Crohn's Disease. He has had small bowel resection twice. The patient has failed ustekinumab, budesonide and adalimumab in the past. The patient was started on golimumab (Simponi) 13 months ago and the patient initially experienced a good clinical response. Now the patient is having pain and trough levels of the biologic are below target. All of this clinical information is written by the appealing provider.

The patient's provider has recommended use of high dose Simponi for management of Crohn's disease. This request is considered not standard of care for the treatment of Crohn's disease and is only Food and Drug Administration (FDA) approved for moderate-severe ulcerative colitis in addition to rheumatologic indications. Therefore, the request was denied by the plan.

The subject under review is whether Simponi is likely to be more beneficial for this patient than any standard treatment.

The requested Simponi 100 milligrams/milliliter (mg/ml) syringe is not likely to be more beneficial for the patient than standard treatment. Golimumab has only been studied in Crohn's disease in observational or retrospective case series. The largest studies are listed in the references. In each observational study golimumab appears to be beneficial for Crohn's; however, these studies are subject to bias and other methodologic flaws due to their study design. The other scenario where golimumab is being used in patients who have Crohn's has been those with a concomitant rheumatologic disorder with the stated goal to treat both diseases.

In this patient it appears that golimumab is not working. There has already been progression of symptoms through treatment on standard doses. The argument is that levels are low but it plausibly could be due to a lack of drug efficacy/mechanistic failure. An alternative standard approach would be to try infliximab either branded or biosimilar.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic dermatitis
Treatment: Dupixent 300 milligrams per 2 milliliters (mg/mL) Subcutaneous (SC) Solution Pen-Injector (SOPN)
The insurer denied coverage for Dupixent 300 milligrams per 2 milliliters (mg/mL) Subcutaneous (SC) Solution Pen-Injector (SOPN).
The denial is overturned.

The patient is an adult patient with a diagnosis of atopic dermatitis. The condition is extensive, affecting large portions of the body surface area. The patient has failed therapy with tacrolimus ointment and multiple topical steroids. The patient has a history of asthma and scalp pruritus. The requested medication is Dupixent. 

The patient has severe atopic dermatitis that involves a large surface area. The patient requires systemic therapy given the extent of involvement and the use of Dupixent would appear to be reasonable given that it is Food and Drug Administration (FDA) approved for the treatment of atopic dermatitis (AD). The request for Dupixent is supported by the medical literature and specialty society guidelines. Dupixent is the first systemic therapy approved by the FDA for the management of atopic dermatitis. The FDA approved Dupixent for adults with moderate-to-severe AD who are inadequately controlled with topical treatments. According to consensus guidelines "Dupilumab (Dupixent) has shown strong efficacy and safety for treatment of moderate-to-severe AD. Considering the safety profiles of conventional systemic therapies, which are not FDA-approved for AD treatment, it is recommended that dupilumab be used as a first-line systemic treatment for patients with moderate-to-severe AD who are uncontrolled with topical therapies". As such, Dupixent is approved at the medical discretion of the physician based on the standard of care and the provided medical documentation.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Dupixent 300 milligrams per 2 milliliters (mg/mL) Subcutaneous (SC) Solution Pen-Injector (SOPN) is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Maxillary and mandibular crowding and anterior crossbite.
Treatment: D8660 pretreatment visits for braces, D8080 braces
The insurer denied coverage for D8660 pretreatment visits for braces, D8080 braces
The denial is overturned

Upon review of the submitted documentation including lateral cephalometric radiograph, panoramic radiograph, montage of extraoral and intraoral clinical images, dental treatment noted as well as insurer correspondence, it appears that this patient presented for evaluation for orthodontic care. The orthodontist identified maxillary and mandibular crowding and anterior crossbite. The orthodontist has completed the Handicapping Labio-Lingual Deviation (HLD) index as required and has chosen the automatically qualifying condition of cross bite of individual anterior teeth when clinical attachment loss and recession of the gingival margin are present. The insurer has denied coverage for orthodontic treatment as not medically necessary as the clinical circumstance does not meet the requirements of the HLD index attaining 16 points by internal reviewers when 26 points are required for approval. 

Upon review of the submitted documentation (study models were not provided for review) it is evident that the patient exhibits a significant malocclusion. However, to assess for severity of the malocclusion and therefore medical/dental necessity for orthodontic care, New York State requires, the use of an orthodontic Index, the Handicapping Labio-Lingual Deviation Index Report (HLD, New York State Medicaid program) modeled after the Handicapping Labiolingual Deviation Index. This index provides six specific conditions that automatically qualify for orthodontic care. Additional criteria are used utilizing a point system if none of these initial qualifying conditions are met or selected. For these other secondary criteria to qualify for orthodontic care a total score of 26 is necessary.
 
In this case, the treating orthodontist claims an automatic qualifying condition of 
cross bite of individual anterior teeth when clinical attachment loss and recession of the gingival margin are present. This reviewer finds that this automatically qualifying condition criterion is met and does support comprehensive orthodontic care. In this case, the clinical circumstance does meet insurer and plan criteria to justify orthodontic care. 

Regarding the validity of the Handicapping Labiolingual Index, it has been shown through scientific scrutiny in peer reviewed journals that this methodology for assessing orthodontic need is a valid approach. Each of these peer reviewed articles concludes that this index is a valid and reliable determinant of need for orthodontic care. As this is an accepted methodology, this has been determined to represent an appropriate approach for assessing orthodontic need. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for D8660 pretreatment visits for braces, D8080 braces is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Acute Kidney Injury (AKI)
Treatment: Inpatient admission
The insurer denied coverage for an inpatient admission
The denial is overturned

The patient is an adult with a history of immunocompromise and recent thoraco-abdominal aneurysm repair who presented to the hospital with complaints of shortness of breath (SOB) as well as abdominal and back pain. The patient also reported that he had been vomiting.

At presentation vital signs were temperature 36.2 degrees Centigrade, blood pressure 88/62, and a pulse of 115. The patient had some abdominal tenderness to exam. There were no pulses of the surgical bypass leg. Labs were significant for White blood cells (WBC) of 11.3 with a left shift, elevated Lactate of 2.4, Blood urea nitrogen (BUN) 29, Creatinine (Cr) 4.49. Hypercalcemia and Hypomagnesemia were also noted. The patient was admitted for an acute kidney injury (AKI), rule out (R/O) occluded Axilla- Femoral Graft , R/O sepsis.

Imaging studies revealed bilateral multi focal chest infiltrates chronic with superadded infiltrates. A Computed tomography (CT) of the Chest /Abdomen /Pelvis showed basal atelectasis and a lower Thoracic and Upper Abdominal Aortic Aneurysm. A urinalysis was positive for WBC, Red blood cells (RBC) and Casts.

The patient was admitted and treated with intravenous (IV) fluids, broad spectrum antibiotics - Vancomycin and Cefepime for possible sepsis. The patient received IV Zofran and was given IV Toradol for pain.

This patient had multiple medical issues including AKI, possible sepsis and the possibility of vascular graft occlusions. The patient needed IV hydration, antibiotics, close monitoring of renal function and electrolytes due to presentation with AKI and electrolyte abnormalities       
and possible sepsis.

The patient improved with hydration and IV antibiotics. Lactate trended down and BUN/Cr slowly normalized. Vascular occlusion was ruled out and the patient was discharged home. 

Based on the patient's presentation and need for aggressive monitoring with repeated labs and close monitoring of vital signs due to presentation with hypotension, admission was appropriate. This patient could not have been managed at a lower level of care.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for inpatient hospital admission is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cellulitis

Treatment: Inpatient hospital admission

The insurer denied coverage for inpatient hospital admission

The denial is upheld. 

This is an adult patient with a history of type one diabetes who presented to the emergency department with complaints of a right hallux infection that started off with a callus that the patient was picking off with their fingers. The patient was admitted due to an elevated white blood cell count (WBC) of 12.3. Initial x-rays did not reveal concerns for osteomyelitis and magnetic resonance imaging (MRI) was recommended but not done. The erythrocyte sedimentation rate (ESR) was elevated to 26. On hospital day 2 the patient's WBC decreased to 9.8 after the patient was started on intravenous (IV) antibiotics and the clinical appearance also improved on the right hallux. The patient's hemoglobin A1C (glycated hemoglobin) was found to be slightly elevated to 6.7. 

Diabetic foot infections can be life threatening and patients with these infections consistently suffer from a plethora of underlying conditions that require a multi-specialty approach to treat.  Timing is crucial, which was the case in the presentation of this patient, who had to be admitted and started on IV antibiotics. This is a justified 24-hour observation admission. Furthermore, due to diabetes, patients with an infection may never "mount a robust systemic response." Complicating risk factors again justify the reasoning behind a 24-hour observation admission. Per the notes made available the patient was discharged due to a lack of childcare and as such the patient was started on oral antibiotics and advised to follow up with podiatry as an outpatient. This patient's care could have been managed in an observation setting.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for inpatient hospital admission is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Abdominal Pain and Vomiting.
Treatment:  Inpatient Hospital Admission.

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

This adult male with a history of alcohol abuse and alcohol withdrawal presented complaining of two days of abdominal pain associated with nausea and vomiting. He had stopped drinking two days prior.

Vital Signs: Temperature = (equal to) 35.9. Pulse = 92. Respiratory Rate = 33. Blood Pressure = 117/89.  Oxygenation saturation = 100%.  Exam was remarkable for diffusely tender abdomen and mild tremors.  Labs: White blood cells (WBC) = 17.5. Hemoglobin/Hematocrit (H/H) = 16.7/49.1.  Platelet (Plt) = 255. Sodium (Na) = 134. Potassium (K) = 4.7. CO2 (Carbon Dioxide) = 12.  Blood urea nitrogen/Creatinine (BUN/Cr) = 22.1.17. Glucose = 154. Lipase = 14.  ALT (alanine transaminase) = 39.  Ethanol < 10.  EKG (electrocardiogram)- showed normal sinus rhythm and no acute ischemic changes.

The patient was admitted with alcohol ketoacidosis and withdrawal. Plan of care included IV (intravenous) fluids and CIWA (clinical Institute withdrawal assessment) protocol. On the next day: Temperature = 36.8. Pulse = 73. Respiratory Rate = 22. Blood Pressure = 152/86. Oxygenation saturation = 98%. Recurrent vomiting. CO2 (carbon dioxide) improved to 26. Abdominal/pelvic CT (computed tomography) was unremarkable. PPI (proton pump inhibitors) changed to IV (Intravenous). Continue IV (Intravenous) fluids. Continue clears. Continue inpatient admission until emesis improves. GI (gastrointestinal) consultation notes symptoms related to alcohol withdrawal. Recommended po (oral) PPI (proton pump inhibitor) and advance diet.
On the following day, the patient was cleared for discharge with outpatient work up.

The proposed treatment was not "medically necessary".

This patient with a history of alcohol abuse and withdrawal was admitted after presenting with abdominal pain, nausea, and vomiting. He was not acutely intoxicated. The patient was hemodynamically stable and afebrile. He had tachypnea. He did not have tachycardia or arrhythmia. Labs were consistent with mild dehydration. He was able to tolerate po (oral) intake. Evaluation was unremarkable for findings severe alcohol withdrawal. He did not have active comorbid conditions. He had not failed an observation level of care. His dehydration rapidly responded to IV (intravenous) fluids. He remained stable during hospital stay and did not have findings of acute alcohol withdrawal. The MCG (Milliman Care Guideline) Adult Substance-Related Disorder guideline for inpatient admission is not met. The patient did not have alcohol withdrawal with an elevated risk due to historical or comorbid factors of delirium, seizure, or other significant medical history. In addition, the patient did not have signs of withdrawal that failed a lesser level of care or where a lower level of care was inappropriate.

Inpatient Hospital Admission was not medically necessary because it was not consistent with generally accepted standards of medical practice for this scenario.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Idiopathic short stature.
Treatment:  Genotropin.

The insurer denied coverage for Genotropin.  The denial is upheld.
 
The patient is an adolescent with a height of 155.3 centimeters (cm) (10th percentile, -1.3 standard deviation scores (SDS)), Weight of 62.9 kilograms (kg) (81st percentile) giving a Body Mass Index (BMI) of 26.04 kg/meter squared (m2) (95th percentile).  Bone age gives a height prediction of 159.9 cm (0.9 percentile).  Midparental target height = 163.8  8.5 cm (centimeters) (3.5 percentile). Growth velocity = 2.5 cm /year (-5.28 SDS). Laboratory data is all within normal limits. The patient's pediatric endocrinologist has prescribed growth hormone therapy based on a diagnosis of idiopathic short stature given the patient's predicted adult height. The insurer has denied growth hormone therapy, stating the patient does not meet criteria for medical necessity.

The diagnosis of idiopathic short stature is based on the definition of short stature as -2.0 SDS.[1].  This patient does not meet criteria for that diagnosis, as current height is at -1.3 SDS.  Though growth hormone (GH) therapy has been Food and Drug Administration (FDA) approved for idiopathic short stature with predicted height less than 63 inches, this patient does not meet criteria for that diagnosis despite his poor predicted height. Furthermore, use of growth hormone and aromatase inhibitors have only been demonstrated to be effective in patients with idiopathic short therapy commencing treatment with a bone age <= 14.5 yrs (years). This patient has a bone age for which no efficacy has been demonstrated.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Genotropin services is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Chest pain.
Treatment:  Inpatient admission.	

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

The patient presented to the hospital with complaints of chest pain, nausea, and shortness of breath. Past medical history was significant for hypertension and chronic lower back pain.  Upon arrival to the emergency department vital signs were stable: blood Pressure was 144/98, and the pulse was 82 beats per minute. Physical examination revealed reproducible pain with palpation of the sternum. A 12-lead electrocardiogram (EKG) revealed sinus rhythm with no evidence of ischemic ST or T wave abnormalities. Serum troponin levels were not elevated (<0.01 nanograms per milliliter (ng/ml)). A review of medical records from the past year revealed non obstructive coronary disease and a calcium score of zero on a computed tomography (CT) of the chest. He was diagnosed with costochondritis and discharged home with a cardiology follow up.

This patient presented with atypical chest pain and a past medical history of hypertension. His pretest probability of coronary artery disease was low. Utilizing the HEART (patient age, medical history, ECG findings, and troponin) score he was considered low risk. Risk assessment of patients presenting with chest pain and no significant ST (intervals on a EKG) changes on the EKG was reviewed by Hedayati et al. Using the HEART score risk stratification schema, this patient would have a low risk of major adverse cardiac events (defined as myocardial infarction (MI), need for percutaneous coronary intervention (PCI), need for coronary artery bypass grafting (CABG), or death) in the six weeks following presentation. In conclusion, admission to the hospital to treat an acute cardiac event was not medically necessary. This patient could have been treated at a lower level of care.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for the inpatient hospital admission is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Heart failure
Treatment: Inpatient hospital admission
The insurer denied coverage for the inpatient hospital admission.
The denial is upheld. 

A gentleman presented to the hospital for elective right and left heart catheterization. He reported progressive shortness of breath and the inability to walk for more than 1-2 blocks without stopping. His past medical history was significant for non-ischemic heart failure with reduced left ventricular ejection fraction of 26-30 percent (%), polycystic kidney disease with serum creatinine of 2.1, and diabetes mellitus. A 12-lead electrocardiogram revealed normal sinus rhythm with left bundle branch block. A right heart catheterization revealed elevated intracardiac pressures with a right atrial pressure of 17 and a pulmonary capillary wedge pressure of 34. A left heart catheterization revealed non-obstructive coronary artery disease. The patient was admitted to the hospital for treatment with intravenous furosemide. The patient was discharged the following day and transitioned to oral, guideline directed, medical therapy. 

This patient presented with a history of worsening dyspnea and was scheduled for elective right and left cardiac catheterization. He was appropriately treated with guideline directed medical therapies. Intracardiac pressures were noted to be elevated and treatment with intravenous diuretics were administered. The patient was discharged the following day on oral agents. Masri, et al compared patient outcomes following treatment of acute congestive heart failure in observation and inpatient settings and demonstrated no difference in mortality between the two groups. In conclusion this patient could have been treated at a lower level of care and did not require an inpatient hospital admission.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably, with sound medical judgment, and in the best interest of the patient. The medical necessity for the inpatient hospital admission is not substantiated.