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

Diagnosis: Atopic dermatitis

Treatment: Dupixent Syn 300

The insurer denied coverage for Dupixent Syn 300

The denial is overturned

Reviewer Findings:	

The patient has a history of atopic dermatitis. The patient was successfully treated with Dupixent previously for several years. The patient has noted flares of atopic dermatitis without Dupixent therapy. The request is for re-initiation of Dupixent.

The patient has atopic dermatitis (AD) that involve a large surface area and has been previously successfully treated with Dupixent for several years.  The patient requires systemic therapy and has failed topical therapies while off of Dupixent. The request for Dupixent is supported by the medical literature and specialty society guidelines.  Dupixent is the only systemic therapy approved by the Food and Drug Administration (FDA) for the management of atopic dermatitis.  In early 2017, the FDA approved Dupixent for adults with moderate-to-severe AD who are inadequately controlled with topical treatments (1-3).  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 ... with moderate-to-severe AD who are uncontrolled with topical therapies".  As such, the decision is overturned and 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 Syn 300 is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ileocolonic Chronic Disease 
Treatment: Stelara
The insurer denied: Stelara
The denial is: Upheld
 
The patient is a female with ileocolonic Crohn's disease. She has reportedly failed Remicade after use over 18 months; as of, she had increasing symptoms prior to infusions every 8 weeks, and infusions every 6 weeks were not covered. The coverage is requested for Stelara. The request was not approved as Humira and Entyvio have not been attempted. The subject under review is whether Stelara is medically necessary for this patient.

The request for Stelara is not medically necessary for this patient.

The request for Stelara is supported over the use of Entyvio but not over the use of Humira for the treatment of Crohn's disease based on the information submitted in this case. Stelara, Entyvio, Humira are recommended by American College of Gastroenterology guidelines for the treatment of Crohn's disease [1]. American Gastroenterological Association (AGA) guidelines for the treatment of Crohn's disease specifically do support the use of Entyvio in patients with Crohn's disease [2]. The guidelines recommend Stelara over Entyvio (but not Humira) in Crohn's disease patients who have secondary non-response to an anti-tumor necrosis factor (such as Remicade, attempted by the enrollee), stating "In adult outpatients with moderate to severe Crohn's disease who previously responded to infliximab (secondary nonresponse), the AGA recommends the use of adalimumab or ustekinumab and suggests the use of vedolizumab over no treatment for the induction of remission" [2].  Two studies showed that Stelara appears more effective than Entyvio in the treatment of Crohn's disease, with one finding odds ratio of remission of 2.01 and the other 2.58 [3,4]. 

However, the use of Stelara is not necessarily supported over the use of Humira. The patient has failed Remicade, which is in the same class as Humira (anti-tumor necrosis factor medications), and guidelines recommend switching to a different class if the enrollee has tested negative for anti-infliximab antibodies and has a therapeutic infliximab concentration, with inflammation present on testing; that has not been documented in this case [5].  Additionally, multiple studies show the superiority or non-inferiority of Humira to Stelara in the treatment of Crohn's disease [6-11]. No contraindication to Humira therapy is documented in this case.
For these reasons, the request for Stelara is not supported over the formulary alternative Humira based on the submitted documentation.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Human Immunodeficiency Virus. 
Treatment: Long Term Custodial Care. 

The insurer denied long term custodial care. The health plan's determination is upheld. 

This is a male with a medical history of human immunodeficiency virus (HIV), hypertension, hyperlipidemia, glaucoma, insomnia, type 2 diabetes mellitus and cerebrovascular accident (CVA) with residual right sided motor deficit who was initially admitted to the hospital for weakness and non-compliance with medications. 

Long term custodial care is not medically necessary for this patient. This patient with a medical history of HIV, hypertension, hyperlipidemia, glaucoma, insomnia, type 2 diabetes mellitus and cerebrovascular accident (CVA) with residual right sided motor deficit was initially admitted to the hospital for weakness and non-compliance with medications. The patient no longer requires physical, occupational or speech therapy, he only requires minimal assistance with activities of daily living and can ambulate 100 feet with a rolling walker. In addition, the patient is taking his medications and his co-morbidities are appropriately controlled with therapy. His medical condition is in a stable state, he only requires minimal assistance with daily activities and has been deemed to be able to be left alone for 6 - 8 hours at a time. His care can be met at a lower level of care. There is no indication from the clinical notes that the patient requires ongoing long term custodial care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Alopecia Areata.
Treatment: Olumiant.
The insurer denied: Olumiant.
The denial is: Upheld.

The patient is a female with alopecia areata, treated with topical steroids. The treating provider is requesting Olumiant. The health plan requires documentation of the patient's Severity of Alopecia Tool (SALT) score. The clinical notes indicate she has widespread loss on her frontal and occipital scalp. The subject under review is the medical necessity of Olumiant for this patient.

The health plan's determination is upheld in whole.

The requested treatment with Olumiant is not medically necessary for this patient. The SALT score should be provided. The patient has tried topicals. Consistent with the standard of care, intralesional steroids can also be provided. Therefore, Olumiant is not medically necessary at this time.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Autoimmune basal ganglia encephalopathy 
Treatment: Gammagard J1569
The insurer denied Gammagard J1569.
The health plan's determination is upheld.

The patient is a female diagnosed with an autoimmune basal ganglia encephalopathy following streptococcal infection, or a pediatric autoimmune neuropsychiatric disorder associated with streptococcal infections (PANDAS). The patient has neuropsychiatric symptoms including obsessive compulsive disorder, anxiety, and tics. Treatment with intravenous immunoglobulin is the subject of this review. 

Gammagard is not medically necessary for this patient.
The use of immunomodulatory therapy for treatment of autoimmune basal ganglia encephalopathy or autoimmune neuropsychiatric disorders related to streptococcal infections remains controversial. In one study, the potential benefits of treatment with plasma exchange or intravenous immunoglobulin (IVIG) compared with placebo were evaluated in a randomized controlled trial in 29 children who met PANDAS criteria and were severely affected. Symptom severity was rated at baseline and at 1 and 12 months after treatment. Substantial improvement in symptoms from baseline was noted in the treatment groups at one month; improvements were maintained at one year, although psychotropic medications were decreased or discontinued in only 7 of 13 patients who required them at baseline. This study was confounded by a lack of control group for the plasma exchange and lack of correlation between therapeutic response and rate of antibody removal.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Parkinson's Disease..
Treatment: Consumer directed personal assistance program (CDPAP) services 12 hours per day - 7 day(s) per week; 12 hours per day - 7 day(s) per week (split-shift) - a total of 168 hours per week .
The insurer denied: Consumer directed personal assistance program (CDPAP) services 12 hours per day - 7 day(s) per week; 12 hours per day - 7 day(s) per week (split-shift) - a total of 168 hours per week. 
The denial is: Upheld.

The patient is a female with medical history notable for Parkinson's disease. The patient is approved for 12 hour per day, 7 days per week (84 hours per week) of consumer directed personal assistance program (CDPAP). The patient and her care team requested an increase to 24 hour per day (2-12 hour split shift) CDPAP. This request was denied by the health plan, and this denial is the subject under review.
A letter of support for this appeal was provided by the patient's treating physician assistant. The letter states that she "now requires 24 hour home health aide due to Parkinson's disease, impairment of balance and macular degeneration. She requires assistance in all areas of activities of daily living (ADL)." There were no further details provided.
A letter of support for this appeal was provided by the patient's orthopedist. The letter states that she has severe spinal stenosis which is affecting her gain and balance. "She is a high risk for falls, therefore extended home care is medically necessary for this patient." No details on unmet personal care needs were provided.

The health plan's determination is upheld.

The requested health increase in consumer directed personal assistance program (CDPAP) services 12 hours per day - 7 day(s) per week; 12 hours per day - 7 day(s) per week (split-shift) - a total of 168 hours per week has not been demonstrated to be medically necessary for this patient.
The patient requires assistance with all ADL's and Instrumental activities of daily living (IADLs). Her UAS did not demonstrate that this was a significant decline from last year. She has intact cognition and can direct her care. Her personal care hours are consumer directed and provided by multiple family members. She should be able to assign her consumer directed hours for various periods throughout the day and night to address her functional needs. It has not been demonstrated that she would require 24 hour continuous care, as there is no recommendation for personal care needs that must occur on a continual basis. The request from her physician stated the hours were to prevent falls, but safety monitoring outside of personal care tasks is not a stand-alone personal care function.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Gastroesophageal reflux disease (GERD).
Treatment:  Formulary Exception for Lansoprazole Orally Disintegrating Tablets (ODT). 

The insurer denied coverage for Formulary Exception for Lansoprazole ODT.  The denial is upheld.

The patient presented with epigastric discomfort and reflux. Famotidine did not help her symptoms. The patient has not had an esophagogastroduodenoscopy (EGD). She reported that she has trouble swallowing pills. 

The American College of Gastroenterology has published Guidelines for the Diagnosis and Management of GERD. The guideline (1) states that proton pump inhibitor (PPI) therapy has been associated with superior healing rates and decreased relapse rates compared to Histamine H2-receptor antagonists (H2 blockers) and placebo for patients with erosive esophagitis. However, the article also states that meta-analysis has failed to show a significant difference in efficacy for symptom relief between PPI's. 

This patient does not like to swallow pills. However, there is no documentation of her having a swallowing disorder that would prevent her from swallowing a tablet. The submitted physician's office note lists several current oral medications including Alprazolam, Rosuvastatin, and Zoloft. The insurance company has provided several alternative PPI preparations that are on the formulary. She has not tried and failed these preparations. 

The formulary drugs are not likely to cause the patient to have an adverse reaction and have not been shown to be ineffective. Lansoprazole ODT has not been shown to be more effective as compared to other PPI's for GERD. 

The request for a formulary exception for Lansoprazole ODT is denied. The formulary drugs are not expected to cause adverse effects. The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication. The formulary drug is not expected to be ineffective. The not formulary drug is not expected to be more effective that the formulary alternatives.

The carrier's denial of Request for Formulary Exception for Lansoprazole ODT is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Seizures
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission
The denial is upheld 

The patient, a child, was seen in the emergency room with a history of seizures and complaints of continuous seizures after discontinuing antiseizure medications 1 month prior to arrival. The triage notes stated that the patient had positive left eyebrow raising with eye deviation for 15 seconds. She was alert, active, and ambulatory with clear lungs and no active vomiting. The emergency department provider noted the patient was diagnosed with a seizure disorder 4 years prior and presented for increased seizure activity for 1 day. She was typically having 10 seizure episodes per day, and halfway through the day, had already suffered 10 seizures. She was afebrile, with negative upper respiratory infection symptoms or recent illness. She was previously on Keppra and valproic acid. She had no medication and claims that they were not working. Seizures were still occurring despite the use of the medications previously. Exam findings noted blood pressure at 90/69, pulse of 103, temperature 97.1 degrees Fahrenheit and respirations 20. Pulse oximetry was 100 percent (%) on room air. Seizures were not appreciated during examination. The physician recommended admission for electroencephalography (EEG) which was normal. The patient had no history of falls, physical alteration/impairments, and did not report altered equilibrium with use of medications. The patient discharge summary claimed that the patient had a diagnosis of Jevon syndrome, eyelid myoclonia, and asthma. The patient's mother described the patient seizure activities as an upward gaze deviation and eyebrow raising. They lasted for a second with no lethargy or confusion afterwards. The patient's mother reported no tongue biting, confusion, loss of consciousness, urinary incontinence, or weakness. The physician claimed that the patient reportedly had greater than 14 seizures before the encounter. The patient had a family history with an older brother who has similar seizures, although these stopped after undergoing a procedure. The patient also had a first-degree cousin with seizures.  

The records referenced the patient was previously monitored with reports of seizures. However, during her time in the emergency room, the records did not support recurrent seizures from an unknown etiology to justify the inpatient stay. There was no need for an inpatient level of care given the provided documentation of no recurrent seizure activity while in the emergency department or observational care with either an unknown seizure disorder, recurrent seizure of a different seizure type, nor was the patient with baseline infrequent seizures and recurrence not thought to be due to readily modifiable etiology (non-adherence, sub-therapeutic drug level).  

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 admission is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Non-ischemic heart failure with reduced ejection fraction
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission 
The denial is upheld

This is the case of an adult female that presented to the hospital for elective cardiac resynchronization therapy implantable cardiac defibrillator (CRT-ICD) placement. Past medical history was significant for non-ischemic heart failure with reduced ejection fraction. Left ventricular ejection fraction (LVEF) was noted to be 19% and 12 lead electrocardiogram (EKG) revealed a left bundle branch block with a QRS duration of 196 milliseconds. The patient underwent successful placement of a CRT- ICD system with coronary sinus left ventricular lead placement. There were no perioperative complications, and the patient was discharged home the following day.

This patient underwent prophylactic ICD implantation without complication. She was discharged the following day. Several studies have demonstrated that following uncomplicated ICD implantation same day discharge is safe and feasible. (Reference 1-3) Inpatient admission was not medically necessary.

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 admission is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Central precocious puberty
Treatment: Fensolvi
The insurer denied coverage for Fensolvi
The denial is overturned

The pediatric patient was diagnosed with central precocious puberty (CPP). This request is for Fensolvi. The patient's luteinizing hormone (LH) was 1.4; follicle-stimulating hormone (FSH) was 3.6; Estradiol was 9. The patient's breasts were at tanner 2 and genitourinary (GU) at tanner 1.

The definition of precocious puberty is children who have the onset of secondary sexual characteristics younger than age 8 in girls and younger than age 9.5 in boys. Central precocious puberty (CPP) is diagnosed using a basal LH of >(greater than) 0.3 or stimulation testing with a Gonadotropin releasing hormone (GnRH) analog such as luprolide showing a pubertal response defined as an LH >10. CPP is treated with GnRH agonists such as lupron, fensolvi and supprelin. The Food and Drug Administration (FDA) indication for GnRH agonists is for use in central precocious puberty (CPP). In addition, when used for CPP the FDA recommends discontinuation of GnRH agonists before age 11 for females and before age 12 for males. This is consistent with accepted recommendations for discontinuation of GnRH agonist therapy at a bone age of 12 in girls and 13 in boys. Per medical records the patient has a basal LH of 1.4 and onset of secondary sexual characteristics at the age of seven. Fensolvi is considered medically necessary for this patient.

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 Fensolvi is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Status asthmaticus and possible pneumonia
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission
The denial is overturned

This is a female child with a history of asthma and a previous admission to the hospital for asthma one year prior to this admission. There were sick contacts in her home, and she had 2 days of coughing and chest congestion. She then developed "heavy breathing" and increased work of breathing which did not respond to albuterol in the home. The parents contacted Emergency Medical Services (EMS) who again administered albuterol during transport to the Emergency Room (ER).

In the ER she was noted to have a pulse oximeter reading of 94%, bilateral wheezing and increased work of breathing. She was treated with 3 doses of inhaled albuterol, atrovent, steroids and intravenous (IV) fluids. A respiratory viral panel was positive for rhino/enterovirus and a chest x-ray showed hyperinflation. Blood testing was normal and there was no evidence of mycoplasma pneumonia. The wheezing improved with treatment in the ER but upon repeat physical examination she continued to have expiratory wheezing and a persistent low oxygen saturation of 93%. Because of the ongoing need for oxygen there was concern for bacterial pneumonia and she was started on IV ceftriaxone. When her hypoxemia did not improve with treatment in the ER the decision was made to admit her with a diagnosis of status asthmaticus and possible pneumonia for ongoing treatment with albuterol every 3 hours, IV ceftriaxone, steroid, oxygen supplementation and IV fluids.  

The insurer has denied the admission as not medically necessary and indicated that there was no documentation in the medical record to support the need for inpatient treatment. 

The patient was treated appropriately in the ER for a cough, wheezing and respiratory distress. She had a history of a previous admission to the hospital in the past for asthma and there was evidence of inadequate response to albuterol in the home during this illness. There was also documentation in the ER record of a strong odor of cannabis noted from both parents which raised concern for the use of marijuana in the home which could have contributed to the child's illness. It was appropriate and consistent with the standard of care to admit her to the hospital for ongoing treatment with albuterol every 3 hours, oxygen supplementation and IV fluids. She had failed outpatient management of her asthma. She continued to have hypoxemia with an oxygen saturation of 93% despite appropriate treatment in the ER and it was consistent with the standard of care to admit the child with a diagnosis of status asthmaticus. The ongoing need for oxygen supplementation and the need for albuterol every 3 hours indicated that she was not stable enough to be discharged safely to the home. 

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 admission is substantiated.