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

Diagnosis: Irritable Bowel Syndrome with Diarrhea	

Treatment: Xifaxan tab 550 milligrams (mg)

The insurer denied coverage for Xifaxan tab 550 milligrams (mg)

The denial is overturned

According to the documentation submitted, this is an adult with a history of irritable bowel syndrome (IBS). The physician requested coverage for Xifaxan tab 550 milligrams (mg).

The insurer has denied coverage for Xifaxan tab 550 milligrams (mg), as not medically necessary. In a Final Adverse Determination letter, they stated that in order to approve coverage for this medication there must be documentation that the patient tried and failed Viberzi, unless there is a history of substance abuse disorder. The requested medication is denied based on Prior Authorization Guideline Name Xifaxan (rifaximin) - PA/Med Nec Formulary UnitedHealthcare Employer & Individual (Fresh Start). 

The patient is appealing. In an appeal letter the patient's Gastroenterologist stated that Viberzi is not a reasonable alternative, and the patient would benefit from Xifaxan. 

The patient has been complaining of bloating and rectal urgency. The patient's bowels have been loose. The patient has undergone a workup including endoscopy, stool testing, calprotectin, and an abdominal ultrasound. The patient has been diagnosed with irritable bowel syndrome with diarrhea (IBS-D). The patient's physician has advised treatment with Xifaxan. 

UpToDate has an article titled "Treatment of irritable bowel syndrome in adults." The article discussed pharmacological treatment of irritable bowel syndrome (IBS) with diarrhea. It addresses the use of eluxadoline. The recommendation is that eluxadoline should only be used in selected patients with severe IBS-D that is refractory to all other agents as it is associated with a high incidence of severe acute pancreatitis. Antibiotics are recommended in patients with moderate to severe IBS without constipation, particularly those with bloating who have failed to respond to other treatments such as dietary modifications. A two-week trial of rifaximin is recommended and if symptoms recur the course of rifaximin can be repeated. In two large, randomized trials rifaximin treated patients experienced improvement in symptoms as compared to placebo. 

This patient has IBS-D. Xifaxan is a Food and Drug Administration (FDA) approved treatment for this condition and has been shown to improve symptoms. It is a safer option as compared to Viberzi. The UpToDate article supports the use of Xifaxan for IBS-D. The health care plan did not act reasonably or with sound medical judgment. Xifaxan is medically necessary for this patient. The denial is reversed.

Based on the above, the insurer's denial must be reversed. 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 Xifaxan tab 550 milligrams (mg) is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obesity.

Treatment: Wegovy 0.25 milligram (mg) / 0.5 milliliter (ml) pen injector.

The insurer denied coverage for Wegovy 0.25 milligram (mg) / 0.5 milliliter (ml) pen injector.

The denial is overturned.

 
The patient has obesity and has completed a 3-month program for weight loss with Weight Watchers. She reports that she follows a healthy diet. She has been started on an exercise regimen. She has previously failed treatment with phentermine. Her Body Mass Index (BMI) is 40.8. Her physician has advised treatment with Wegovy. 

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. 

An article in JAMA 2021;325(14):1414-1425 is titled "Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults with Overweight or Obesity." 803 participants in this study were randomized to either continue Semaglutide or to take a placebo after 20 weeks of semaglutide treatment. Those who continued the treatment with semaglutide had ongoing weight loss, a better lipid profile, improved glucose metabolism, better blood pressure control, and physical functioning scores. The group who took the placebo regained their weight. The article states that the result of this study emphasizes the chronicity of obesity and the need for treatments that can maintain and maximize weight loss. 

This patient has a BMI over 40. Wegovy is an FDA approved treatment for obesity in patients with a BMI over 30. The medical literature supports the beneficial effects of semaglutide in achieving weight loss in obese patients. 

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 Wegovy 0.25 milligram (mg) / 0.5 milliliter (ml) pen injector is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: spondylolysis
Treatment: Lab Work/blood tests
The insurer denied Vitamin D Testing. The Vitamin Testing is not medically necessary. 

The patient is a boy who presented with back pain associated with L (lumbar) 4 vertebral spondylolysis and a partially-sacralized L5 vertebral body. The orthopaedic surgeon recommended brace treatment with a thoracic lumbar sacral orthosis (TLSO) in hopes of healing the spondylolysis and improving the back pain. He also recommended physical therapy and limitation of his activities. He ordered a blood test for Vitamin D level; it was said to be low and treatment with a Vitamin D supplement was begun.

The Vitamin D testing is not medically necessary.
The question is whether the presence of L4 spondylolysis in a young adolescent should be considered an indication for vitamin D testing. While there are published articles identifying vitamin D deficiency in similar patients, and in patients with many other orthopaedic conditions such as fractures and scoliosis, there are also many articles establishing that vitamin D deficiency is very common in the general population of children and adolescents based on current definitions of deficiency.
One article states that "Unreliability of commonly used vitamin D assays and lack of agreement regarding the definition of a 'normal' population has led to some difficulty in the establishment of reference ranges for serum Vitamin D concentrations." It is unclear whether children with moderate deficiency suffer any ill effects from it, and whether treatment is clinically beneficial. It is also acceptable to recommend a vitamin D supplement without preliminary testing. This patient did not have a condition in which clinically significant vitamin D deficiency could be reasonably suspected as being causal, and therefore, the vitamin D testing is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Eosinophilic esophagitis
Treatment: Dupixent
The insurer denied: Dupixent
The denial is overturned.

The patient is a teenage male. He has a diagnosis of eosinophilic esophagitis (EoE). The health plan denied coverage of the requested Dupixent, noting that there is no history of an average of at least two episodes of dysphagia. The denial is being appealed.

Te requested Dupixent is medically necessary.

Dupixent is FDA (United States Food and Drug Administration)-approved to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms (which is about 88 pounds). The efficacy and safety of Dupixent in EoE (eosinophilic esophagitis) was studied in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial (not yet published), that included two 24-week treatment periods (Part A and Part B) that were conducted independently in separate groups of patients. In Part A of the trial, 60% of the 42 patients who received Dupixent achieved the pre-determined level of reduced eosinophils in the esophagus compared to 5% (percent) of the 39 patients who received a placebo. In Part A of the trial, 60% of the 42 patients who received Dupixent achieved the pre-determined level of reduced eosinophils in the 
esophagus compared to 5% of the 39 patients who received a placebo. In Part B, 59% of the 80 patients who received Dupixent achieved the pre-determined level of reduced eosinophils in the 
esophagus compared to 6% of the 79 patients who received a placebo. The patient's weight is 40.82 kilograms. The patient has had difficulty swallowing at least twice a week. The patient has tried several therapies including fluticasone, Nexium, Pulmicort, and methylprednisolone. Budesonide was working for the patient but is no longer covered by insurance. The patient had a biopsy that showed a maximum of 16 eosinophils per high power field. The patient meets the FDA (United States Food and Drug Administration)-approved indication for the use of Dupixent for EoE (eosinophilic esophagitis). The denial reason has also been addressed by the provider. The patient has had difficulty swallowing at least twice a week.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Aortic stenosis. 
Treatment: Transcatheter Aortic Valve Replacement (TAVR) and Inpatient Hospital Stay.  
The insurer denied Transcatheter Aortic Valve Replacement (TAVR) and Inpatient Hospital Stay. 
The health plan's determination is overturned. 

The patient is a male who developed symptomatic severe aortic stenosis. There was no coronary disease. His PFTs (pulmonary function tests) were normal. There was also a history of diabetes and hypertension. The left ventricular ejection fraction (LVEF) was normal. 

Transcatheter Aortic Valve Replacement (TAVR) and Inpatient Hospital Stay is medically necessary for this patient. 
TAVR is a nonsurgical percutaneous procedure for an aortic valve replacement for individuals with symptomatic severe aortic stenosis (AS) at prohibitive surgical risk. There are some established risk assessment guides to determine those eligible for the procedure. They are based primarily on clinical factors such as, for example, severe pulmonary disease, severe renal disease, extent of coronary artery disease (CAD), cardiac function, immunosuppressive therapy, and other valvular disease. There are also technical factors related to sternotomy contraindications that are considered, such as a previous sternotomy, porcelain aorta, and past chest radiation. These technical factors are not necessarily part of clinical risk assessment criteria but are important considerations. 
In this case, the patient was not a high risk for surgery. However, there is recent evidence (Popma, et al.) that TAVR, compared to surgical aortic valve replacement, in those at low surgical risk is associated with a lower rate of a composite endpoint of mortality, stroke, and recurrent hospitalizations. It is therefore considered medically necessary in this case. As the procedure is necessary so too is the requirement for an inpatient hospitalization.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Breast cancer

Treatment: Proton beam radiation therapy

The insurer denied coverage for proton beam radiation therapy

The denial is upheld.

 
This is the case of an adult female patient with recurrent left breast cancer. Patient underwent lumpectomy and plan is to consider adjuvant radiation therapy (RT) using proton beam therapy (PBT) with a dose of 35 Gray in 10 treatments.

The radiation oncologist has provided dose volume histogram (DVH) comparison of PBT and Intensity-modulated radiation therapy (IMRT). Maximum Heart dose from photon (IMRT) is 464 centigray (cgy) compared to 0.3 cgy from proton beam therapy. Maximum left lung dose from photon is 1966 cgy compared to  302 cgy  from proton.

Thus, proton delivers significantly lower dose ,however, dose delivered through photon IMRT are within acceptable limit . Thus, PBT is not medically necessary.

The information provided does not justify PBT. National Comprehensive Cancer Network (NCCN) guidelines do not suggest PBT for breast cancer. Proton beam therapy (PBT) is being evaluated under National Cancer Institute (NCI) sponsored trials. 


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 proton beam radiation therapy (PBT) services is not substantiated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Hypothyroidism
Treatment: Formulary exception for Synthroid 125mcg (micrograms) Tablet
The insurer denied: Formulary exception for Synthroid 125mcg (micrograms) Tablet
The denial is upheld.

The patient is an adult female diagnosed with Hypothyroidism. This request is for Synthroid 125 microgram Tablet. As per the provided letter, the patient has a history of hypothyroidism controlled on brand Synthroid. She has been on generic levothyroxine a few times in the past, which caused repeated fluctuations in her TSH (thyroid stimulating hormone), both below and above therapeutic range.

The health plan should not cover the Formulary exception for Synthroid.

The health plan's formulary requires the trial and failure of the preferred formulary alternatives, including Euthyrox, levothyroxine, Levoxyl and Unithroid. The patient is reported to have failed only levothyroxine. The remaining formulary alternatives would reasonably be expected to be as effective and as safe as the requested non-formulary drug. The health plan should not cover the Formulary exception for Synthroid, as the patient can try the remaining formulary alternatives.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dementia

Treatment: Consumer Directed Personal Assistance Services (CDPAS); 84 hours per week

The insurer denied coverage for Consumer Directed Personal Assistance Services (CDPAS); 84 hours per week

The denial is overturned

This is a patient with chronic medical problems including hypertension, heart disease and dementia. The patient lives alone in a private residence. The patient's family is supportive and involved in their care. The patient's nephew is the Consumer Directed Personal Assistance Services (CDPAS) designated representative. The insurer increased the patient's CDPAS from 25 to 49 hours/week and the request is for an increase of CDPAS 84 hours/week, leading to an external review.

According to the Uniform Assessment System (UAS) report, the patient's cognition is described as moderately impaired. The patient has a history of wandering in their apartment and outside (elopement risk). A Ring camera and alarm have been installed in the home due to elopement risk. The patient is reportedly total dependent for performing much of their Instrumental Activities of Daily Living (lADL) tasks including meal preparation, ordinary housework and shopping. The patient reportedly requires extensive assistance for bathing, lower body dressing and toilet use. Limited assistance is reportedly needed for personal hygiene, upper body dressing, eating, bed mobility, locomotion, toilet transfer and ambulation. However, the patient is able to ambulate using a cane and has been found outside of their home. The patient is reportedly frequently incontinent bladder and occasionally incontinent of bowel. There have been no reported falls over the prior 90 days.

The patient's clinical condition and functional deficits are at a level and unpredictable as to require increasing CDPAS 84 hours/week. The patient has dementia, dependent for most IADLS and activities of daily living (ADLs), is ambulatory using assistive device which in their case results in wandering with resultant significant risks. The combination of needs for ADLs and IADLs along with her safety needs supports increasing her CDPAS to 84 hours/week. 

The healthcare plan did not act reasonably, with sound medical judgment and 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, an increase in Consumer Directed Personal Care Services (CDPAS) 84 hours/week is medically necessary.

Based on the above, the insurer's denial must be reversed. 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 Consumer Directed Personal Assistance Services (CDPAS); 84 hours per week is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Fever and Cough
Treatment: Inpatient admission
The insurer denied: Inpatient admission
The denial is upheld.

The patient is a school age male child. He has a medical history significant for eczema. He presented to the emergency department with three-day history of cough productive of greenish phlegm, post-tussive emesis, decreased appetite, ear fullness and pain, and fever to 102. The patient's vital signs included temperature 37.4, heart rate 145, respiratory rate 32, and blood pressure 112/70. Examination was significant for bilateral erythematous tympanic membranes, congestion with rhinorrhea, dry mucous membranes, 3+ tonsils, tachycardia, tachypnea with prolonged expiration, rhonchi without wheezing, benign abdomen, and non-focal neurologic deficits. He was diagnosed with moderate dehydration and viral infection (viral syndrome versus pneumonia versus upper respiratory infection with gastroenteritis). The patient's chest X-ray was unremarkable. Labs were significant for white blood cell (WBC) 
count 10.97K (thousand) with 84.6% (percent) neutrophils and C-reactive protein (CRP) 170.7. Respiratory panel returned positive for adenovirus. He was treated with two normal saline boluses, a dose of azithromycin, and a dose of Tylenol prior to admission to the pediatric ward for further management. The patient's admission orders included intravenous fluids, pediatric diet as tolerated, supplemental oxygen, Tylenol as needed, and repeat labs in the morning. He continued to have fevers, with worsening cough, headaches, and copious diarrhea. He was given Pedialyte to replace the fluid losses and remained on intravenous fluids. Nasal spray, nebulized saline treatments, and probiotics were added. Repeat C-reactive protein was slightly better at 103.9. Metabolic panel included sodium 134 and CO2 (carbon dioxide) 23. Repeat chest X-ray remained negative. By day #3, his oral intake had improved significantly, he was afebrile and more active and playful. He was deemed stable for discharge to follow-up with his pediatrician in three days.

The inpatient admission was not medically necessary.

This young male child presented with respiratory symptoms, fever, and later development of diarrhea. He was moderately dehydrated upon presentation requiring intravenous fluids, with 
addition of Pedialyte with onset of diarrhea. While it was reasonable to monitor this child in the hospital to monitor fluid balance and resolution of dehydration, he was overall hemodynamically stable with no evidence of impending hypovolemic shock or significant metabolic derangements. 
He did not require acute inpatient admission and could have been safely managed at lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohns's disease
Treatment: Infliximab (Inflectra) 
The insurer denied Infliximab (Inflectra) 
The determination is overturned.


This is a female patient with a history of Crohn's disease. She was started on infliximab (Inflectra) but continued to have active disease and her drug level was low despite dose escalation to 10 milligrams (mg) per kilogram (kg) every 8 weeks. The requested service is infliximab dose escalation to 12.5 mg per kg every 8 weeks. This is under review for medical necessity.
Infliximab as requested is medically necessary.
The management of inflammatory bowel disease is very complicated, and the available treatments are limited. It is very common for patients with Crohn's disease to lose response to their biologic over time or to require higher than standard dosing.
There are many peer-reviewed literature reports showing that low infliximab levels were associated with poor clinical response. Dose escalation is often required in order to improve the drug levels and maintain remission. The experience with dose escalation of infliximab has been extensive in both adult and pediatric patients. The available scientific evidence strongly supports the safety and efficacy of this approach.
According to the clinical practice guidelines: "Intravenous administration of infliximab (Remicade) is usually at 5 mg/kg with three induction doses over 6 weeks [weeks 0-2-6], followed by maintenance therapy of 5 mg/kg every 8 weeks. However, there is ample evidence that children less than 30 kg, and those with extensive disease and low serum albumin levels, require higher induction doses up to 10 mg/kg, shorter dosing intervals, or both, to reach target trough levels" (6).
Per Hendler, Steven A., et al. doses between 10 and 22.5 mg/kg every 4 to 7 weeks have been used for Crohn's disease.
This patient failed to adequately respond to the lower doses or infliximab and had low drug levels.
Therefore, continuation of infliximab at 12.5 mg per kg every 8 weeks is medically necessary.