Persius/hicric huggingface dataset:
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Diabetes. 
Treatment: Bydureon Bcise (exenatide extended release). 

The insurer denied coverage for Bydureon Bcise (exenatide extended release). 

The denial is upheld. 

According to the documentation submitted, this is a female patient with a history of diabetes, hypertension, hyperlipidemia, and chronic obstructive pulmonary disease (COPD). She presented to her physician's office for a follow up visit. The patient has had trouble keeping her glycated hemoglobin (HbA1c) level down. The physician recommended continuing Bydureon to treat diabetes. 

The plan has denied coverage for Bydureon BCise (exenatide extended release). The plan approved criteria covers this drug when the patient has tried and had an inadequate treatment response or intolerance to the required number of formulary alternatives or there is a documented reason such as an expected adverse reaction or contraindication preventing the patient from trying formulary alternatives. Formulary alternatives are Ozempic, Rybelsus, Trulicity, and Victoza. The requirement is trial and failure of all the formulary alternatives, but not more than three. 

The formulary drugs are not likely to cause the patient adverse reaction.  All Glucagon-like peptide (GLP)-1 analogs have the same side effects of Nausea and gastro-intestinal reactions. 

According to the documents provided the claimant has tried and failed Victoza but the reaction was not specified.  There is no documentation that the claimant has tried and failed Ozempic, Rybelsus and Trulicity which are the formulary drugs aside from Victoza. 

There is no evidence that Bydureon would be more effective than the formulary drugs such as Ozempic and Trulicity and in fact there is literature evidence that Ozempic and Trulicity are superior to Bydureon in terms of A1c lowering. 

"Background: Several pharmacological treatment options are available for type 2 diabetes; however, many patients do not achieve optimum glycaemic control and therefore new therapies are necessary. We assessed the efficacy and safety of semaglutide, a glucagon-like peptide-1 (GLP-1) analogue in clinical development, compared with insulin glargine in patients with type 2 diabetes who were inadequately controlled with metformin (with or without sulfonylureas)...Interpretation: Compared with insulin glargine, semaglutide resulted in greater reductions in HbA1c and weight, with fewer hypoglycaemic episodes, and was well tolerated, with a safety profile similar to that of other GLP-1 receptor agonists." (Aroda, V.R., et al. 2017). 
  
The insurer's denial of coverage for Formulary Exception for Bydureon BCise (exenatide extended release) is upheld.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Cardiac/Circulatory Problems. 
Treatment: Pharmacy/Prescription Drugs. 

The insurer denied Edarbi. 

The insurer's denial is upheld. 

The patient is a male with diagnosis of essential hypertension who has been treated with Edarbi 80 milligrams (mg) daily for several years. Coverage for Edarbi 80 mg daily was denied by insurer stating patient needed to have a trial and failure of all formulary alternatives, but not more than 3. The patient's medical provider noted the patient had tried losartan and olmesartan and these did not control blood pressure. 

The health plan's determination is upheld. 

There is documentation that losartan and olmesartan have not been effective at treating patient's blood pressure. There would not be a specific clinical reason candesartan, irbesartan, telmisartan, or valsartan would be less effective or have adverse side effects when compared to non-formulary drug, Edarbi. The patient must try and fail all formulary alternatives, but not more than three. At this time, the patient has tried and failed two formulary alternatives. There is no reason the other mentioned formulary drugs cannot be attempted.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Type 2 Diabetes Mellitis.
Treatment: Formulary exception for Metformin ER (generic Fortamet).
The insurer denied the Formulary exception for Metformin ER (generic Fortamet).
The denial is overturned.

The patient is a female with type 2 diabetes. The request for metformin ER (extended release) (generic Fortamet) is under review. She has tried and failed metformin and metformin extended release due to gas, bloating, and loose stools.

Yes, the health plan should cover the Formulary exception for Metformin ER (generic Fortamet).
This request is for generic Fortamet for the treatment of type 2 diabetes. The formulary alternatives are metformin and metformin extended release. This patient has tried the formulary alternatives, which resulted in adverse effects. Specifically gas, bloating, and loose stools. Without generic Fortamet, this patient will be at increased risk of uncontrolled hyperglycemia, which can cause retinopathy, neuropathy, and nephropathy. Therefore, yes, the health plan should cover the formulary exception for generic Fortamet.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Endocrine/Metabolic/Nutritional. 
Treatment: Pharmacy/Prescription Drugs/ Apidra, Humalog. 
The insurer denied Apidra, Humalog. 
The denial is upheld. 

The patient is a male with type 2 diabetes, hypertension, and hyperlipidemia, who presented for diabetes care. He was currently being treated with insulin via the Omnipod insulin pump. As per notes, the patient has a history of erratic blood sugar control with Novolog insulin. He uses the Dexcom clarity app to check and monitor his blood sugars. His last glycated hemoglobin test (HbA1c) was 7.6%. The patient has a history of coronary artery disease with 2 stents placed. He is being treated with Repatha for hyperlipidemia. For insulin therapy, he has tried Novolog twice, Apidra and Admelog with abnormal glucose control.
At issue is whether the formulary drugs, Fiasp, Novolog, will be or have been ineffective, would not be as effective as the non-formulary drug, Apidra, Humalog.

The health plan's determination is upheld in whole. 

There is no evidence that the formulary drugs faster-acting insulin aspart (Fiasp) and insulin aspart (Novolog) are less effective that the non-formulary drugs insulin glulisine (Apidra) and insulin lispro (Humalog).
Looking at the pharmacokinetics and pharmacodynamic profiles of each insulin, they are very similar. The molecular structures of insulin lispro, aspart and glulisine (Apidra) are very similar to regular human insulin, with only one amino acid change for insulin aspart and two amino acid changes for insulin lispro and insulin glulisine. Because of the similarities of their profiles, the directions for administering the rapid-acting analogues are almost identical. Clinical laboratory studies have shown that the profiles are very similar to the physiological effect of endogenous insulin. Of five studies that compared insulin lispro and insulin aspart, only two detected a significant difference. The ultra-rapid acting insulins (Fiasp and Apidra) are non-inferior to rapid-acting insulin and may even show better post-prandial glucose control. However, there are no studies that consistently document that one is superior over another. There was no supporting documentation that the patient had an inadequate treatment response or contraindication to the formulary insulins. There is no evidence that the patient cannot be switched to the formulary drug.
Therefore, the formulary drugs faster-acting insulin aspart (Fiasp) and insulin aspart (Novolog) are not less effective that the non-formulary drugs insulin glulisine (Apidra) and insulin lispro (Humalog).
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Unspecified lack of coordination.
Treatment: One unit of each neuromuscular reeducation (97112) and therapeutic exercise (97110).

The insurer denied coverage for one unit of each neuromuscular reeducation (97112) and therapeutic exercise (97110).
The denial is upheld.

This is a child with reported history of unspecified lack of coordination.  Treatment included but not limited to occupational therapy.  Currently under review is the medical necessity of 1 unit of each neuromuscular reeducation (97112) and therapeutic exercise (97110).

The occupational therapy (OT) treatment notes provide insufficient objective clinical information to support the medical necessity for the services under review.  The treatment notes for each visit usually consist of 2-3 sentences documenting general areas of concentration, which are non-specific and woefully inadequate.   There are no quantitative or verifiable measures of improvement.  There is no evidence the treatment is expected to result in significant therapeutic improvement over a clearly defined period of time. The treatment plan is not individualized or appropriately correlated with any specific physical examination findings.  In addition, there are no documented treatment goals that are functionally oriented, measurable, and evidenced based.  

The health plan acted reasonably, with sound medical judgment and in the best interest of the patient.  Including but not limited to, the clinical standards of the plan, the 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 societies boards and associations were taken into consideration.

From a physical medicine and rehabilitation perspective, as well as within a reasonable degree of medical certainty, based on the treatment records, the 1 unit of each neuromuscular reeducation (97112) and therapeutic exercise (97110) for each were not medically necessary.

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

The insurer's denial of coverage for one unit of each neuromuscular reeducation (97112) and therapeutic exercise (97110) for each is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Seizure
Treatment: Inpatient Hospital Stay
The insurer denied the Inpatient Hospital Stay.
The determination is upheld.


The patient has no significant past medical history and presented to the hospital after a seizure at home. The seizure lasted 2 minutes and the patient had 5-10 minutes of confusion afterwards. She had no tongue biting. She was brought to the emergency room for evaluation. She was admitted to the hospital. A magnetic resonance imaging (MRI) scan of the brain was performed. It was negative for an acute process. An electroencephalogram (EEG) was not performed and it was deferred to the outpatient setting. An anticonvulsant was not started because it was the patient's first seizure. She was discharged from the hospital.
At issue is the medical necessity of an inpatient stay.

No. The requested health service/treatment of inpatient stay is not medically necessary for this patient.
The patient presented to the emergency room after a seizure at home. This was the patient's first seizure. She did not have multiple seizures. She did not have a prolonged post-ictal state. She did not have any significant laboratory or imaging that required an acute inpatient admission. The patient did not have any significant cardiographic abnormalities that required inpatient admission. She had an MRI of the brain which showed no acute abnormalities. The patient did not have an electroencephalogram. She was not started on a seizure medication.
All of this care could have been performed at a lower level than inpatient. There was no medical condition that required an acute inpatient admission.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: Missing Teeth
Treatment: Endosteal Implant, Teeth #s 2, 3, 5, 6, 7, 13, 14, 15, 18, 19, 20, 21, 30,
and 31

The insurer denied the Endosteal Implant, Teeth #s 2, 3, 5, 6, 7, 13, 14, 15, 18, 19,
20, 21, 30, and 31.
The denial is overturned, in part.

The patient is a female who has multiple missing teeth in the upper and lower jaws. The request is for multiple implants to be placed.

The denial was due to there being no reason(s) given why removable prosthetics
(i.e. full or partial upper denture and a partial lower denture) cannot be used.

Yes, in part; the proposed implants are medically necessary for teeth #s 3, 5, 6, 7,
13, 14, 18, 20, 21, and 30. However, the proposed treatment for teeth #s 2, 15, 19,
and 31 are not medically necessary.
The patient has been stated as being unable to wear dentures. The patient cannot
chew food properly the way the teeth are, with the teeth that are missing. The
provider wants to place implants in the following positions: 2, 3, 5, 6, 7, 13, 14, 15,
18, 19, 20, 21, 30 and 31.

This is far too many implants. Many people chew and survive very well with only
one molar in a quadrant; there is no reason to place implants on the patient's right
side in the areas of teeth 2 (upper right) and 31 (lower right). These would be
second molars, and they are not needed. Not having them would in no way
compromise the patient's eating ability.

Also, there is no need for an implant where tooth #15 is, since there already is a
viable tooth there. On the lower left, there is no need for an implant for tooth #19,
since an implant supported bridge can be placed on the implants #18 and #20.

The fewer implants that need to be placed, the better for this patient. There will be less implants to heal, less complications and the chewing ability without these four implants (#'s 2, 15, 19 and 31) will not be compromised at all.

No, in part; the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient as implants for teeth #s 3, 5, 6, 7, 13, 14, 18, 20, 21, and 30 were medically necessary. However, the health plan did act reasonably, with sound medical judgment and in the best interest of the patient as teeth #s 2, 15, 19, and 31 are not medically necessary.

There is information supporting some of the requested implants; however, some of the requested implants are not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic dermatitis
Treatment: Dupixent
The insurer denied Dupixent.
The health plan's determination is upheld.

The patient is a female with atopic dermatitis. Body surface area affected is greater than 10% (percent). She has tried and failed triamcinolone, prednisone, and cetirizine. 

Dupixent is not medically necessary for this patient. There are no comparative, controlled studies showing that Dupixent has a superior efficacy or safety profile to the formulary alternatives.

According to the American Academy of Dermatology Atopic Dermatitis Clinical Guidelines and dermatology literature, the health plan's preferred medications are effective treatments for the management of atopic dermatitis. It is noted that the patient has tried and failed topical steroids. However, the patient has no true contraindications to the other preferred, formulary medications which have been shown to be effective for the treatment of atopic dermatitis. The preferred agents are appropriate agents for the treatment of the patient's atopic dermatitis. Therefore, Dupixent is not medically necessary for this patient based on the evidence-based literature.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gout, hydrocephalus, diabetes, bipolar disorder, hyperlipidemia

Treatment personal care assistance (PCA) 24hours per day, 7 days per week split shift.

The insurer denied coverage for personal care assistance (PCA) 24hours per day, 7 days per week split shift.

The denial is overturned

This patient has multiple medical problems including hydrocephalus, diabetes, bipolar disorder and hypertension.  She was hospitalized due to lower extremity weakness and difficulty walking. She was transferred to a skilled nursing facility and would like to return home. She lives alone in a private residence. She was approved for PCA, 56 hours/week. Under review is the request for personal care assistance (PCA) 24hours per day, 7 days per week split shift.

According to the Uniform Assessment System (UAS) report the patient does not have significant cognitive deficits. Cognitive skills are described as "modified independent." However, she requires maximal assistance for activities of daily living tasks that include lower body dressing and toilet transfers/use. She is incontinent of bowel and bladder.  She requires day and nighttime assistance. Extensive assistance is also required for personal hygiene and upper body dressing. The patient's progressive functional decline supports the medical necessity of personal care assistance (PCA) 24hours per day, 7 days per week split shift, to allow her to resume living safely at home.  

The insurer's denial of coverage for personal care assistance (PCA), 24 hours per day, 7 days per week split shift is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic Sinusitis. 
Treatment: Dupixent. 

The insurer denied Dupixent. The health plan's determination is overturned. 

The patient is a male with a history of nasal polyposis, anosmia, chronic sinusitis, allergic rhinitis, and asthma. Past surgical history was significant for septoplasty and endoscopic sinus surgery. Previous allergy testing was performed. He is currently on immunotherapy. 

Past medical treatment was significant for topical budesonide, but the patient continued to have progressive nasal polyp issues. The patient was unable to continue antihistamines, azelastine, and Singulair under the direction of his urologist. He did continue with the Dupixent and a topical steroid (budesonide rinses). 

Dupixent 300mg syringe is medically necessary for the patient. Current community standards for the use in Dupixent in the patient population with chronic sinusitis with nasal polyposis suggest that patients should fail conventional medical therapy prior to the use of monoclonal antibodies. In the case of this patient who has undergone prior surgical therapy in addition to topical steroids (Budesonide) and immunotherapy, Dupixent is medically necessary. There is no consensus in the community otolaryngologists that patients should be on mometasone prior or during Dupixent usage. This patient has responded well to Dupixent with decrease/stability of nasal polyps. Current practice-based evidence suggest that this patient should continue with the Dupixent therapy.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Endocrine/Metabolic/Nutritional.
Treatment: Surgical services.
The health plan denied the endoscopic sleeve gastroplasty as not medically necessary. 
The reviewer has overturned in whole the health plan's determination.

The patient has obesity status post sleeve gastrectomy. She had significant weight loss , and then has regained weight. Her body mass index was 38 kilograms per meters squared (kg/m2). She has attempted exercise and medical and dietary interventions for weight loss, including phentermine. The coverage is requested for endoscopic sleeve gastroplasty for the treatment of Class II.

The request of endoscopic sleeve gastroplasty is supported as medically necessary. Endoscopic sleeve gastroplasty can alter gastric anatomy. A study of 91 patients with BMI of 40.7 kg/m2 reported 14.4% (percent), 17.6%, and 20.9% weight loss at 6, 12, and 24 months; at 12 months, glycated hemoglobin test (A1c), waist circumference, alanine aminotransferase, and triglycerides all improved significantly (Sharaiha, et al). A multicenter case series of 248 patients with BMI(body mass index) of 37.8 kg/m2 found 15.2% weight loss at 6 months and 18.6% at 24 months (Lopez-Nava, et al). A study of 1,000 consecutive patients with body mass index of 33.3 kg/m2 reported 13.7%, 15.0%, and 14.8% weight loss at 6, 12, and 18 months; 13 of 17 cases of diabetes mellitus, all 28 cases of hypertension, and 18 of 32 cases of dyslipidemia were in remission by month 3 (Alqahtani, et al). All these studies reported a low rate of serious adverse events. A meta-analysis including 1,772 patients reported 16.5% weight loss at 12 months, and 17.2% weight loss at 18-24 months; the rate of serious adverse events was 2.2% (Hedjoudje, et al). A study of 82 patients showed that the technique is effective to address weight regain after sleeve gastrectomy, with a very low rate of adverse events (Maselli, et al). As the patient has morbid obesity with multiple comorbidities, and failure of pharmacologic therapy, intervention is recommended by guidelines (Wolfe, et al).
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Kidney Stones.
Treatment: Acute inpatient admission.

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

This is a female with history of asthma, leukopenia of unclear etiology, overweight and prior kidney stone and urinary tract infection. The patient presented to the emergency department with nausea, urinary frequency, diarrhea and progressively worsening, severe right lower quadrant (RLQ) abdominal pain radiating to the right flank. Emergency department exam revealed tachycardia, tachypnea, and right costovertebral angle tenderness (CVAT). The patient continued to have symptoms despite emergency department treatment, was admitted for further treatment. The patient ultimately underwent cystography, right retrograde, right URS (ureteroscopy) with lithotripsy, stone removal, stent placement. The patient's symptoms improved post procedure, and she was discharged home with outpatient follow up. 

Per Milliman Care Guidelines (MCG) health (25th): I) Renal Colic + Kidney Stones - patient fails to meet clinical indications for admission to inpatient care. II) Urologic Surgery or Procedure General Recovery Guideline (GRG) - patient is noted to have met the discharge parameters within 24 hours post procedure.

As per the guidelines, this patient's Urologic procedure is usually performed in the ambulatory surgery setting. 

The acute inpatient admission is not considered medical necessary for this patient.

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

The insurer's denial of coverage for an acute inpatient admission is upheld. Medical Necessity is not substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Chronic idiopathic Constipation.
Treatment: Formulary exception for Motegrity.
The insurer denied the Formulary exception for Motegrity.
The denial is overturned.

The patient is a female with Elhers Danlos Syndrome, POTS (postural orthostatic tachycardia syndrome), constipation, gastroparesis, thoracic outlet syndrome, chronic fatigue syndrome.  She has nausea, weight loss, early satiety, anorexia, feeding intolerance, bloating.  She has a nasoduodenal tube.  She has received Botox into the pylorus.  The request is for Motegrity.

Yes, the health plan should cover the Formulary exception for Motegrity.
The formulary drugs would be less effective.  The formulary and non-formulary drugs would have similar adverse effects.

Motegrity is used off-label for gastroparesis. Alternative medications such as Reglan may cause tardive dyskinesia.

Per a study by Carbone F et al, thirty-four patients with gastroparesis were evaluated in a double-blind crossover trial of 4-week treatment periods with placebo or prucalopride 2 mg (milligrams) q.d. (daily), separated by 2 weeks of washout. For the entire patient group, compared with placebo, prucalopride significantly improved the total Gastroparesis Cardinal Symptom Index and the subscales of fullness/satiety, nausea/vomiting, and bloating/distention. Prucalopride significantly improved the overall Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score  and the domains of clothing and diet. The gastric half emptying time was significantly enhanced by prucalopride compared with placebo and baseline respectively).

Therefore, given the above, the health plan should cover the formulary exception for Motegrity.