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

Diagnosis: Crohn's Disease.
Treatment: Budesonide ER (extended release) 9mg (milligrams).

The insurer denied: Budesonide ER 9mg.  The denial is upheld.

The patient is an adolescent female with weight loss, diarrhea, abdominal pain, and fatigue. She has terminal ileitis secondary to Crohn's disease. The request is for Budesonide.

The health plan denied coverage of the request, noting "State law requires us to approve Budesonide ER 9mg when the clinical information received is consistent with the approved U.S. Food and Drug Administration (FDA) or supported in at least one of the official compendia. We have communicated with your provider. At this time, the information that we have received from your provider does not show that the drug is supported as medically necessary to treat your specific health condition, and so we are unable to approve your request." The denial is being appealed.

The requested Budesonide is not medically necessary.

The request is for Budesonide ER (extended release) 9 mg (milligrams), which is more appropriate for use in ulcerative colitis or Crohn's colitis. This patient has terminal ileitis secondary to Crohn's disease. A more appropriate medication would be Budesonide EC (enteric coated) (or brand Entocort EC [enteric coated]), which is FDA (United States Food and Drug Administration) approved for Crohn's disease and is released in the terminal ileum.

Therefore, given the above, the requested Budesonide is not medically necessary.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Atopic Dermatitis.
Treatment: Formulary exception for Adbry 150mg/ml (milligrams per milliliter) Syringe.
The insurer denied: Formulary exception for Adbry 150mg/ml (milligrams per milliliter) Syringe.
The denial is overturned.

The patient is an adult male with atopic dermatitis for whom Adbry 150mg/ml (milligrams per milliliter) Syringe is requested. He has tried and failed Dupixent injections (flared with injections), prednisone, Eucrisa, various topical steroids, and tacrolimus. The affected BSA (body surface area) is 75% (percent). He has started treatment with Adbry through the bridge program and is improving.

The health plan should cover the Formulary exception for Adbry.

Even though Rinvoq is on the formulary, the side effect profile greatly favors Adbry as the next step in the management of this patient's disease. Additionally, the FDA (United States Food and Drug Administration) recommends Rinvoq to be used when all other therapy options are exhausted, including biologics, or when the use of certain therapies is inadvisable, thus placing them behind Dupixent (dupilumab) and Adbry (tralokinumab).

Adbry (tralokinumab-ldrm) injection is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry can be used with or without topical corticosteroids. The most common adverse reactions (incidence 1%) are upper respiratory infections, conjunctivitis, injection site reactions, and eosinophilia.

Rinvoq is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. The most common adverse reactions in Rinvoq clinical trials were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, headache, increased blood creatine phosphokinase, hypersensitivity, folliculitis, abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like illness, elevated liver enzymes, and rash. They advise informing patients that retinal detachment has been reported in clinical trials with Rinvoq. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving Rinvoq. Rinvoq has caused serious infections, malignancies and death in clinical trials; hence, the black box warning. JAK (janus kinase) inhibitors are known for their fast onset of action but have lately been facing class-wide safety concerns stemming from Pfizer's post-marketing Oral Surveillance study (NCT02092467).

Therefore, given the above, the health plan should cover the Formulary exception for Adbry.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Breast Cancer. 

Treatment: FoundationOne CDx (companion diagnostic) Testing (cpt 0037U). 

The insurer denied the FoundationOne CDx  (companion diagnostic) Testing (cpt 0037U). 

The denial is upheld. 

The patient in this case is a woman diagnosed with breast cancer. Foundation One testing was performed. 

No, the FoundationOne CDx (companion diagnosistic) Testing was not medically necessary. 

Foundation One testing is a next generation sequencing assay that is done to look for genomic alterations in tumor tissue. This test includes over 300 genes. It is done to try to find potentially effective treatment options. There is currently no evidence based on the results of any prospective clinical trial that has shown use of broad molecular profiling can improve overall health outcomes. This test is not recommended as a standard test known to improve overall health outcomes by NCCN (National Comprehensive Cancer Network) guidelines. Given these considerations, this test is not medically necessary. 

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: Rib fractures
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The health plan's determination is upheld.

The patient is a man who presented to the emergency department (ED) following a 15-foot fall from a ladder. Comorbid health conditions included hypertension, hyperlipidemia, and diabetes. He complained of left chest pain at the time of presentation. There was no loss of consciousness. 

The Inpatient hospital admission was not medically necessary in this case. The care and treatment provided could have been rendered at a lower level of care. This patient presented to the ED following a fall from a ladder in which he sustained left sided rib fractures 9-12. He was clinically stable at the time of presentation with normal heart rate, oxygen saturation, and labs. He was able to ambulate and was able to tolerate a diet. He was provided pain medications and was able to participate with physical therapy. He remained clinically stable throughout the period of monitoring. A lower level of care would have provided for the care and treatment necessary for this patient.
Inpatient admission may be indicated in the setting of rib fractures for hemodynamic instability, 3 or more rib fractures, flail chest, acute respiratory failure, pain management, associated injury, infection, hypoxemia, tachypnea, immediate surgery needed or other condition. This patient did have left rib fractures 9-12. However, he was clinically stable with normal vital signs and normal oxygen saturation. Pain management was with a combination of oral and topical medications. He was stable for discharge within one day of presentation. The care provided in this case could have reasonably and appropriately been rendered at a lower level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Uterine Fibroids
Treatment: Procedure to treat fibroid tumors in uterus
The insurer denied the procedure to treat fibroid tumors in uterus.
The health plan's determination is upheld. 

The patient is a female with heavy menses and uterine fibroids. She describes symptoms including dysmenorrhea, painful intercourse, pelvic pressure and multiple other symptoms for at least 4 years. Pelvic ultrasound showed a 6 centimeter (cm) myoma. 

Radiofrequency Ablation Procedure is not medically necessary for this patient.
Bradley and co-workers (2019) carried out a systematic review of prospective studies for treatment of uterine fibroids with radiofrequency ablation (RFA). At 12 months follow-up, fibroid volume decreased by 66 %. The authors concluded that RFA of uterine fibroids significantly reduced fibroid volume, provided significant durable improvements in fibroid-related quality of life (QOL), and was associated with favorable re-intervention rates.
The authors stated that there were several drawbacks pertaining to the quality of the included studies that may influence conclusions. First, there was less precision in the RFA results following 12 months of follow-up since fewer studies reported longer term data. Second, the number of included studies was insufficient to perform statistical comparisons among RFA delivery approaches for several outcomes. Third, it was not possible to determine from this analysis whether RFA efficacy was influenced by fibroid type or volume due to concerns of aggregation bias whereby real associations observed at the patient level. Finally, these researchers planned to report the frequency of complications in this meta-analysis; however, complication reporting was highly inconsistent and inadequate such that any attempts at reporting these data would have led to inaccurate and misleading results.
Therefore while a promising modality for the treatment of uterine fibroids, there does not exist any long-term studies that show a significant improvement over standard therapies. In addition, the gold standard of myomectomy or hysterectomy would still be superior to RFA and this time. Further research needs to be completed before the treatment can be considered standard of care and medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dry Eye Disease (DED).
Treatment: Xiidra.

The insurer denied Xiidra.  The denial is overturned.

The patient is a female who presented with severe dry eye disease (DED). She has a history of laser-assisted in situ keratomileusis (LASIK) and cataract surgical procedures. The patient has severe symptoms that accompany her dry eye disease. This patient has not had any success with over the counter treatment for symptoms of DED. Clinical findings included abnormal tear osmolarity and a decreased tear break up time. The patient has previously used punctal plugs and a multitude of dry eye medications that have not limited or improved her symptoms. Xiidra was given in sample form, and the patient responded saying that it was "life changing" in regard to improving the symptoms of dry eye syndrome. The subject under review is the medical necessity for the Xiidra.

The health plan's determination is overturned.

Xiidra 5% ophthalmic solution (OP SOLN) is medically necessary for this patient. It is quite common for patients status post LASIK to have severe dry eye syndrome. Xiidra has been proven to create symptom relief in dry eye disease (DED) in 14 days as opposed to the 3 - 6 months before other medications may even start to work. DED has an inflammatory etiology. Artificial tears do nothing more than "soothe" the symptoms of dry eye temporarily. They do not work to alleviate the inflammatory nature of DED disease as Xiidra does. The time frame of symptom relief is so far superior with Xiidra, it is clearly the proper treatment choice. In addition, the prolonged symptoms of this patient were immediately improved with use of Xiidra. Previous treatment methods were attempted with no success.

Xiidra is a preservative-free solution of lifitegrast 5% ophthalmic solution. It is Food and Drug Administration (FDA) approved to treat dry eye disease (DED). The drug went through four separate multicenter, prospective, placebo-controlled, randomized, double-masked FDA clinical trials. Given the rapid onset of effect (14 days is more rapid than any other drug studied to date for DED), and it has good safety profile. In this case it will allow the patient to return to comfortable contact lens wear, adequate visual acuity and a resolution of DED symptoms.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental Disorder. 
Treatment: Braces and monthly visits. 

The insurer denied Braces and monthly visits. 
The determination is overturned. 

This patient has a Class I malocclusion with protrusive maxillary incisors. She has a 7-millimeter (mm) overjet and a 4 mm deep bite. She has minor maxillary and severe mandibular crowding. She is treatment planned for 30-36 months of orthodontics with extraction of the four first premolars to correct this malocclusion. At issue is the medical necessity of braces and monthly visits. 

Teeth number (#) 8 and #9 are protruding forward within the dental arch. This makes them more prone to trauma. There is strong medical evidence that that early correction of patients with prominent maxillary front teeth can reduce the risk of incisal trauma. (1) Evidence shows orthodontic treatment will reduce the chances of damage to the maxillary incisors and the associated morbidity of repairing these teeth. Additionally, this patient's overjet is greater than 6 mm. Overjets of this magnitude are shown to negatively affect the oral health quality of life. (2) 

For these reasons, the treatment is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obesity

Treatment: Wegovy

The insurer denied coverage for Wegovy

The denial is overturned.

The patient has been followed by a physician for weight management. She had been treated with Ozempic and had the dose increased but the drug supply was no longer available. She has a body mass index over 60. She has been on a low glycemic diet and has been encouraged to increase her physical activity. She was referred to a dietician. Her physician is now recommending Wegovy. The current body mass index (BMI) is listed as 64.57. Records show she was started on .25 mg (milligrams) Ozempic and due to lack of weight loss progressively increased to 1.0. The current prescription is for 2.4 mg which is not available as Ozempic but is available as Wegovy. Note that both name brands are in fact semaglutide. Ozempic is only available up to 1mg. 

UpToDate has an article titled "Obesity in Adults: Drug Therapy." The article states that a number of medications are approved by the Food and Drug Administration (FDA) for the treatment of obesity in conjunction with healthy eating, physical activity, and behavior modification. Candidates for drug therapy include those with a BMI over 30 or a BMI over 27 with related comorbidities. Semaglutide is a Glucagon-like Peptide-1 (GLP-1) agonist that is approved for the treatment of obesity. It has demonstrated efficacy in weight reduction, as well as improvement in glycemia and lipids. It has also demonstrated cardiovascular benefits.

This patient has massive obesity and has been advised by her physician to be on a diet and exercise program. In view of the massive obesity, giving semaglutide is appropriate. Wegovy is approved by the FDA for the long-term treatment of obesity. It can be used as long as it remains beneficial for the patient in maintaining weight loss and is not causing intolerable side effects. 

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

The insurer's denial of coverage for Wegovy is overturned. The medical necessity for Wegovy services is substantiated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Esophagitis
Treatment: Omeprazole-Sodium Bicarbonate Powder
The insurer denied coverage for Omeprazole-Sodium Bicarbonate Powder.
The denial is upheld.

The patient has cerebral palsy with mental retardation (CPMR) and is dependent on a percutaneous endoscopic gastrostomy (PEG). An endoscopy revealed Grade B esophagitis. He has been treated with Omeprazole-Sodium Bicarbonate. The chart also states that he has been on esomeprazole. A medical progress note that was submitted indicates that metoclopramide was added to his regimen.  

The American College of Gastroenterology has published Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease. (1) The guideline states that proton pump inhibitor (PPI) therapy has been associated with superior healing rates and decreased relapse rates compared to Histamine (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 PPIs. It is noted that Omeprazole-sodium bicarbonate is more effective in the first 4 hours of sleep. However, it has not been shown that this leads to any superior clinical outcomes.

This patient has esophagitis and requires PPI therapy. The insurance company is offering multiple choices of PPI therapy including generic dexilant, esomeprazole, lansoprazole, omeprazole, and pantoprazole. The submitted medical record does not document that the patient has failed these agents. The formulary drugs are not likely to cause an adverse reaction. It has not been shown that giving Omeprazole-Sodium Bicarbonate will produce better clinical outcomes as compared to the formulary PPIs that have been offered. 

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 non-formulary drug is not expected to be more effective that the formulary alternatives.

The carrier's denial of request for Formulary Exception for Omeprazole-Sodium Bicarbonate Powder is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: High blood pressure.
Treatment: Inpatient admission.
The health plan denied the inpatient hospital stay.
The health plan's determination is upheld.

The patient is a male with a history of hypertension (stopping medications three years ago). He presented to the emergency room with swelling of the ankles, headache, abdominal pain and trouble urinating. His vital signs were remarkable for an initial blood pressure of 206/102. He was in no acute distress and was not appearing toxic. The physical exam revealed suprapubic tenderness and bilateral lower extremity edema. The patient's labs revealed a hemoglobin of 10.5 grams per deciliter (g/dL), a very slightly elevated creatinine of 1.26 milligrams per deciliter (mg/dL), a minimally elevated troponin, and a very elevated brain (or B-type) natriuretic peptide (BNP) at 3570 picograms per milliliter (pg/mL). His chest x-ray showed cardiomegaly but no consolidation or effusions. The renal ultrasound was non-contributory. The electrocardiogram (EKG) showed sinus rhythm with premature atrial contraction (PACs) and left ventricular hypertrophy with repolarization abnormalities. A Foley catheter was placed and intravenous and oral blood pressure medications were administered. One dose of intravenous furosemide was also prescribed. Four hours later his blood pressure was down to 187/95, and 10 hours later it was down to 166/73. The patient was admitted for further treatment and evaluation. 

Upon admission to a monitored bed, the patient was treated with oral medications and the continuation of the Foley catheter. The next day the cardiologist evaluated the patient and recommended continuation of oral medications, an echocardiogram and eventually a stress test. Additional diuretics were not recommended. Also, an echocardiogram showed left atrial enlargement and minimal left ventricular diastolic dysfunction. The remainder of the stay was clinically uneventful and the patient was discharged. 

The patient was hemodynamically stable, had no mental status changes and no severe metabolic disarray. The abnormal renal function was minimal and the urinary retention did not require acute inpatient care. Therefore, based on the standard of care, as well as the peer reviewed literature the acute inpatient level of care was not medically necessary and the patient could have been managed at a lower level of care. 

Upon presentation, there was no objective evidence on physical exam, labs, imaging, or EKG of an imminently life-threatening cause of the patient's complaints that required acute inpatient admission. His blood pressure responded to straightforward treatment within several hours. Other than some leg edema there was no other symptoms consistent with heart failure, and there was little evidence of an acute coronary syndrome. 

Based on a thorough review of the information provided, the requested acute inpatient stay was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriasis
Treatment: Tremfya
The insurer denied Tremfya.
The health plan's determination is upheld.

The patient is a male with moderate to severe psoriasis (25% [percent] body surface area involvement) of the trunk and extremities. The patient has previously tried and failed topical steroids such as clobetasol and halobetasol creams. The patient's past medical history includes arthropathy of the knees, essential hypertension, mixed hyperlipidemia, and syncope. The patient takes celecoxib and lisinopril for these conditions. 

Tremfya is not medically necessary for this patient.

The patient has no documented treatment failure with, or true medical contraindication to, standard, first-line systemic therapies such as either Methotrexate, Acitretin, and/or Phototherapy. Particularly for a patient with a limited history of systemic psoriasis therapy previously utilized, these preferred agents are appropriate for the treatment of this patient's clinical scenario. Therefore, Tremfya is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Class I occlusion with a slightly deep overbite and appropriate overjet
Treatment: Braces
The health plan denied coverage for braces.
The health plan's determination is upheld.

The patient is a female with a Class I occlusion with a slightly deep overbite and appropriate overjet. She has minor maxillary and mandibular spacing. Tooth number 4 is in crossbite. She has a treatment planned for 24 to 30 months of orthodontics to correct her malocclusion but her insurance company rejected the claim on the basis that treatment is not medically necessary.

The health plan its determination of medical necessity, acted reasonably, with sound medical judgment and in the best interest of the patient. The patient has very minor crowding. Her overbite is slightly deep but there is no indication of damage to the incisors in the photographs. Her cephalometric radiograph shows the lower incisors are contacting the maxillary teeth in occlusion, not the palate. There is no indication from the photographs that there is severe soft tissue damage (or any soft tissue damage) on this patient.

There is no medical reason to correct her malocclusion with braces. While the patient has minor spacing, there is no anterior crossbite. There is no evidence of wear or periodontal recession. There are functional problems that may occur in the dentition that become more difficult, if not impossible, to correct if not addressed in adolescence. This patient presents with none of those conditions. Aligning her teeth will likely not increase chewing efficiency since masticatory efficiency is already highest in patients with a Class I occlusion. If her teeth were aligned it would provide a minor esthetic improvement but it would not create a medically significant improvement to the patient's health. For these reasons treatment is not medically necessary.