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

Diagnosis: Jaundice
Treatment: Inpatient hospital stay

The health plan denied the inpatient stay as not medically necessary.  The reviewer has upheld in whole the health plan's determination.

The patient was born by vaginal delivery at 39.1 weeks gestation. The infant was seen in the physician's office 7 days later and noted to have increasing jaundice, which was also noted prior to her discharge from the hospital. The infant was reported to be voiding regularly but had not passed a stool since passing meconium. Prior to 48 hours, the jaundice was noted to be in the high intermediate risk zone at 9.8 milligrams per deciliter (mg/dL). The patient had weight loss of 210 grams (6%) below her birthweight noted on Day of Life (DOL) #7. The infant was exclusively breast fed with problems latching and feeding. A bilirubin was 19.1 mg/dL. The parent was contacted and instructed to take the infant to the hospital for admission to the floor.

Per the hospital Discharge Summary, a bilirubin obtained after admission was 14.4 mg/dL. After 12 hours of conventional phototherapy, a bilirubin was 12.6 mg/dL. A repeat rebound bilirubin obtained 7 hours after discontinuation of phototherapy was 12.9 mg/dL. A bilirubin obtained prior to discharge was 9.3 mg/dL. The neonate had two bowel movements prior to discharge.

The requested health service/treatment of Inpatient Stay was not medically necessary for this patient. A lower level of care is appropriate for this neonate with a bilirubin of 19.1 mg/dL at 7 days of life. Per the American Academy of Pediatrics (AAP) guidelines on hyperbilirubinemia, for a low-risk patient whose bilirubin level is below phototherapy level, as in this case, but who is within 2-3 mg/dL of phototherapy level for treatment, it is an option to provide home phototherapy or phototherapy in the hospital setting. Because the same treatment (i.e., conventional phototherapy) can be provided in the home setting, the care in the hospital could be safely provided at a lower level of care.

Per the American Academy of Pediatrics published guidelines, a bilirubin of 21 mg/dL at day of life 7 would meet criteria for conventional phototherapy in a well infant born greater than or equal to (> or =) 38 weeks. The neonate in this case had a bilirubin of 19.1 mg/dL. The AAP guideline does note that it is "an option to provide conventional phototherapy in hospital or at home at levels 2-3 mg/dL below those shown but home phototherapy should not be used in any infant with risk factors." In the case under review, the infant could have received conventional phototherapy in the hospital as was performed because the bilirubin of 19.1 mg/dL was within the 2-3 mg/dL of phototherapy level at 21 mg/dL. However inpatient level of care was not medically necessary. The patient could have been treated at a lower level of care.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Atrial Fibrillation. 
Treatment: Formulary exception for Eliquis. 

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

The patient is a male. The patient has history of atrial fibrillation and requires anti coagulation per guidelines. Eliquis was prescribed, but the health plan's formulary is limited to Xarelto and warfarin. No other clinical information was submitted for review. 

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

Both Xarelto and warfarin have indications for the patient's condition, however recent data suggest that outcomes are improved with Eliquis as compared to the formulary medications. Recent studies also show increased bleeding and increased events in the formulary drugs compared to Eliquis. 

Eliquis was found to be more effective than warfarin in lowering the risk of stroke and systemic embolism. People who took Eliquis also had significantly fewer bleeding episodes than those who took warfarin. 

In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials) 

A review and meta-analysis of Eliquis and Xarelto for acute venous thromboembolism (VTE) concluded that both drugs were similarly effective, but that Eliquis is evidenced to be safer. The patients treated with Xarelto experienced more bleeding, both major and minor. 

A study finds that apixaban (Eliquis) is preferable to rivaroxaban (Xarelto) for stroke prevention, reduced bleeding complications. 

Among Medicare beneficiaries 65 years or older with atrial fibrillation, treatment with rivaroxaban compared with apixaban was associated with a significantly increased risk of major ischemic or hemorrhagic events.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Inpatient Hospital. 
The insurer denied inpatient stay. 
The denial is upheld.

The patient is a female. She has a history of leukemia. She presented to the emergency room for abdominal pain. She was well appearing on presentation and her vital signs were normal. She had a computed topography (CT) scan and laboratory studies done; all were reassuring. She was admitted for further management. The subject under review is the medical necessity for the inpatient stay.

The health plan's determination is upheld.

Inpatient level was care was not medically necessary. The patient had abdominal pain but no emesis, dehydration, or changes in mental status. She had normal vital signs of presentation and was well appearing. She did not have severe electrolytes abnormalities and her imaging was not concerning for a surgical etiology. No evidence of bowel obstruction, ileus or intra-abdominal abscess.
Her care was not complex and did not require surgical procedures or advanced intravenous therapies. She did not require supplemental oxygen or total parenteral nutrition. Her care could have been provided at a lower level of care safely and effectively.
Therefore, the admission to inpatient acute level of care was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest pain; shoulder pain
Treatment: Inpatient admission
The insurer denied the inpatient admission
The denial is upheld.

The patient is a female for which an inpatient hospitalization is under review. She presented with two days of chest, arm, and shoulder pain worse laying down and better with movement. Vital signs and the ECG (electrocardiogram) were essentially normal.  One of three troponins was slightly above normal range. She was in no distress. She remained stable. A MPI (myocardial perfusion imaging) stress test was normal. She was discharged.

No, the Inpatient admission was not medically necessary.
This patient presented with atypical chest pain and remained stable. There was no CHF (congestive heart failure), respiratory distress, ongoing symptoms suggestive of treatment refractory angina or angina equivalent, severe arrhythmia, hemodynamic instability, another serious cause for chest pain, such as a PE (pulmonary embolism) or aortic dissection, need for prolonged IV (intravenous) medications or oxygen support, introduction of high risk medications requiring ongoing in-hospital monitoring, or definitive supporting evidence for an acute coronary syndrome such as elevated cardiac biomarkers or an abnormal ECG (electrocardiogram). In the setting of this case, an acute inpatient level hospitalization, compared to observation, has not been established as standard of care towards improved cardiac outcomes. It is therefore considered not medically necessary in this case.

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Substance Abuse
Treatment: Inpatient Detoxification Services 
The insurer denied the Inpatient Detoxification Services 
The denial is upheld.

The patient is a male. He was admitted to inpatient detox level of care. The patient left against medical advice. The patient was admitted for treatment of problems with alcohol and crack cocaine. The patient admitted to alcohol use for the past several decades at 3+ (plus) cans of beer per day. His last use was the day before admission. The patient had also been smoking crack cocaine daily, about $ (dollars) 50-$100 worth. CIWA (clinical institute withdrawal assessment) or COWS (clinical opiate withdrawal scale) scores are not noted in the records.

The patient's vital signs were stable on admission. The patient denied any history of tremors or blackouts. He denied any mental health, medical or legal issues. His mental status exam was normal. He had no suicidal or homicidal ideation. He did not have a history of multiple past treatment attempts with at least five admissions for detox. His urine drug screen was positive for cocaine.

The health plan denied coverage of the inpatient admission as not medically necessary. This denial is being appealed and is the subject of this review.

No, the Inpatient Detoxification Service was not medically necessary.
Medical records did not show the patient was at high risk for severe or complicated withdrawals from alcohol. Medical records did not document patient has a history of severe withdrawal, delirium tremens, or withdrawal seizures. Medical records did not document a history of severe medical problems in the past when withdrawing from alcohol or cocaine. Medical record also did not document active withdrawal symptoms. CIWA (clinical institute withdrawal assessment) and COWS (clinical opiate withdrawal scale) scores were not noted in the records. The patient's vital signs were stable. The patient could have been treated at a lower level of care without compromising the patient's care or safety.

In addition, treating the patient at a lower level of care would have been consistent with New York State LOCADTR (Level of Care for Alcohol and Drug Treatment Referral) guidelines.

Yes, the health plan acted reasonably with sound medical judgment and in the best interest of the patient.
Health plan followed the criteria recommended by the American society of addiction medicine for alcohol abuse treatment, inpatient detoxification level. In addition, treating the patient at a lower level of care would have been consistent with New York State LOCADTR (Level of Care for Alcohol and Drug Treatment Referral) guidelines.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Acute Diverticulitis.

Treatment inpatient hospital admission.

The insurer denied coverage for inpatient hospital admission.

The denial is upheld.

The patient presented with lower abdominal pain. He had nausea but it had improved by the time of admission. He had a low-grade fever. The emergency room (ER) note states that there was no abdominal rebound or guarding. The initial white blood cell (WBC) count was 13.4 but on repeat was 11.0. An abdominal computed tomography (CT) scan was read as acute sigmoid diverticulitis without a fluid collection or free air. He was treated with antibiotics with a plan for an outpatient colonoscopy.

Clinical indications for admission for Acute Diverticulitis (MCG M-150) include hemodynamic instability, peritoneal signs, persistent gross bleeding, and a significant abnormality seen on imaging studies. This abnormality can be a fistula, obstruction, or free perforation. The patient did not have these conditions or require a drainage procedure. He also did not have bacteremia, severe vomiting, severe dehydration, or an inability to maintain oral hydration after observation care.

This patient had acute diverticulitis that was not complicated by a fluid collection or perforation. It could have been treated with a course of oral antibiotics. He did not meet MCG (Milliman Care Guidelines) criteria for admission for Acute Diverticulitis. 

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

The insurer's denial of coverage for the inpatient hospital admission is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's disease
Treatment: Entyvio
The insurer denied Entyvio.
The determination is overturned.

The patient has Crohn's disease. He was diagnosed with indeterminate colitis, but has had a recent finding of active inflammation with rectal sparing concerning for Crohn's disease. He has had intermittent abdominal pain and diarrhea. A colonoscopy showed erythematous, ulcerated mucosa in the cecum, ascending colon, and transverse colon and normal mucosa in the descending colon, sigmoid colon, and rectum. He has failed prednisone, budesonide, and mesalamine. At issue is the medical necessity for Entyvio for the treatment of Crohn's disease.

Yes the request for Entyvio is medically necessary. The patient has indeterminate colitis with a concern for Crohn's disease given the distribution of inflammation on recent colonoscopy. Per the American College of Gastroenterology guidelines for primary therapy, immunosuppressants such as azathioprine, 6-mercaptopurine, and methotrexate are given a weak recommendation (level 2 evidence), and tumor necrosis factor (TNF) inhibitors such as Infliximab are strongly recommended (level 1 evidence) [1]. These recommendations are corroborated by the American Gastroenterological Association (AGA) Guidelines for Initial Medical Treatment in Crohn's Disease [2,3]. For patients with moderate-severe Crohn's Disease, these guidelines recommend biologic therapy over thiopurine monotherapy [1,3]. No other alternatives are recommended-immunosuppressants (such as azathioprine, 6-mercaptopurine, methotrexate) may take up to 17 weeks to be effective, and aminosalicylates, corticosteroids, and antibiotics are not recommended as long-term primary therapy as they are unlikely to prevent complications. Recent American College of Gastroenterology and AGA guidelines do not recommend thiopurines for the initial treatment of Crohn's disease either [4,5]. For these reasons, the patient is unlikely to respond to conventional alternatives for induction of remission [1-4].
Entyvio has shown efficacy for the treatment of Crohn's disease, and is recommended as a first-line treatment for both induction and maintenance of remission [4,5]. In patients with Crohn's disease and inadequate response to one or more standard therapies. In the GEMINI II trial, It proved efficacy for induction of remission in a randomized controlled trial of 368 patients, as well as a large cohort of 747 patients; it has also proven effective for maintenance of remission, achieving a 39% remission rate in patients who had failed prior therapies [6-8]. For these reasons, the medical necessity of Entyvio is supported in this case.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: atopic dermatitis
Treatment: Dupixent
The insurer denied Dupixent. The health plan's determination is overturned. 

The patient is a female with atopic dermatitis, treated with topical steroids, prednisone, wet wraps, and bleach baths. The patient also has a history of Langherhans cell histiocytosis (LCH) and received chemotherapy. The Provider is requesting Dupixent. The patient has begun treatment and is responding well. 

Dupixent is medically necessary for this patient.
This patient has severe disease and has required systemic steroids and antibiotics. She has a history of LCH and has required chemo making immunosuppressants less favorable.
There are ongoing trials looking at the use of Dupilumab in children as young as six months old. A phase 3 clinical trial by Regeneron began enrolling patients in 2015 and is looking at children between ages 6 months to 18 years and is assessing the long term safety and efficacy of dupilumab for atopic dermatitis. In another 2-part study that started in 2017, the safety, pharmacokinetics and efficacy of Dupilumb in patients 6 months to less than 6 years of age is being evaluated.
In May 2020, the Food and Drug Administration (FDA) also approved dupilumab for the treatment of patients aged 6 years and older with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. This approval followed a phase 3, randomized, double blinded placebo controlled trial that enrolled 367 patients to evaluate the safety and efficacy of dupilumab in children (ages 6-11 years) for treatment of atopic dermatitis. Significantly and clinically meaningful improvements in patients signs and symptoms of atopic dermatitis as well as quality of life were reported.
As seen in adults, treatment in pediatric population was reportedly well tolerated with the most commonly reported side effects including injection site reactions and conjunctivitis. The use of Dupixent in this case is indicated.
Appeal type: Medical necessity
Decision: Overturned

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

The patient is a male with a history of Crohn's disease. His disease is diffuse and affecting the upper gastrointestinal tract in addition to the colon (pan-enteric). The subject under review is the medical necessity for Humira.

The health plan's determination is overturned.

This patient has a diffuse, pan-enteric Crohn`s disease. Anti-tumor necrosis factor alpha (TNFa) (such as Humira) are the standard of care in managing severe and diffuse Crohn`s disease. The clinical practice guidelines recommend early biologic therapy for selected children with high risk for poor outcome such as patients with severe pan-enteric disease (Ruemmele FM, et al). Conventional therapies, such as immune-modulators, are less likely to be effective in treating severe Crohn`s disease in children. Azathioprine and methotrexate are not Food and Drug Administration (FDA) approved for the treatment of Crohn`s disease. Corticosteroids are not suitable for long term use. Sulfasalazine products have no role in pediatric Crohn`s disease treatment and lack efficacy.
Furthermore, there is growing scientific evidence supporting the early use of biologics in the treatment of pediatric Crohn`s disease. Many peer reviewed literature reports showed superior efficacy and less disease complications when biologics are used early in the disease course. Yun Seok Lee, et al, showed that early anti TNFa use led to decrease relapse rate compared to conventional therapies in pediatric Crohn's disease.
Thomas D. Walters et al, showed improved effectiveness with early use of Anti-Tumor Necrosis Factor-a in pediatric Crohn`s and improved growth parameters. Other studies showed that early use of biologics can delay disease progression to stricturing and/or penetrating disease when compared to conventional therapy (Basavaraj Kerur et al.).
Therefore, the request for Humira is medically necessary and appropriate and supported by the clinical practice guidelines.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: Parkinson's disease, congestive heart failure and chronic kidney disease

Treatment:  7 day x 24 hour split shift (2x12) PCA service (168 hours per week)

The insurer denied coverage for 7 day x 24 hour split shift (2x12) PCA service (168 hours per week)

The denial is modified.

This is a male patient with Parkinson's disease, congestive heart failure and chronic kidney disease.  According to the case notes, the plan approved 7 days x (times) 5 hours of personal care assistant  (PCA) service (35 hours/week).  The plan approved 7 days x 6 hours of PCA service (42 hours/week).  Under review is the medical necessity for requested 7 days x 24-hour split shift (2x12) for PCA service (168 hours/week).

According to the Uniform Assessment System (UAS) report, the patient's cognitive ability is described as "minimally impaired."  He can "verbalize daily care needs and direct his care."  He is also "able to verbalize emergency plan to call 911" and "use programmed phone to call daughter."  The patient requires extensive assistance for lower body dressing; otherwise, he requires only limited assistance for bathing, personal hygiene and toilet use/transfer.  He is occasionally incontinent of bladder and completely continent of bowel.  The patient's cognitive and functional impairments do not support the medical necessity of the requested 7 days x 24-hour split shift (2x12) for PCA service (168 hours/week).  However, increasing PCA service to 7 days x 10 hours (70 hours/week) is clinically appropriate and medically necessary to allow the patient to continue living safely at home.   

The healthcare plan did not act reasonably, with sound medical judgment or in the best interest of the patient.  (Taken into consideration were the clinical standards of the plan, information provided concerning the patient, the attending physician's recommendation and applicable generally accepted practice guidelines developed by the federal government, national or professional medical society, board and associations.  All decisions are evidence-based).  

From a physical medicine and rehabilitation perspective, coverage for 7 days x 24-hour split shift (2x12) for personal care assistance service (168 hours/week) is not medically necessary.  However, increasing PCA services to 7 days x 10 hours (70 hours/week) is clinically appropriate and medically necessary.

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for a 7 day x 24 hour split shift (2x12) for personal care assistance service (168 hours per week) is modified. Medical Necessity is substantiated for PCA service for 7 days x 10 hours (70 hours/week).