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

Diagnosis: Ulcerative Colitis. 
Treatment: Mesalamine DR 800MG DR TAB. 

The insurer denied the Mesalamine DR 800MG DR TAB. 
The denial is overturned. 

The patient is a male with ulcerative colitis.  The patient started mesalamine and noticed a small amount of blood in the stools.  He started balsalazide and had blood stools.  The patient had an allergic reaction to sulfasalazine. 

Yes, the requested Mesalamine is medically necessary. 

The 5-aminosalicylic acid (5-ASA) derivatives available in oral formulations include balsalazide, mesalamine, olsalazine and sulfasalazine. 

Asacol, Asacol HD (delayed release) and Delzicol tablets contain a pH-sensitive film that dissolves at a higher pH, thereby delivering mesalamine to the terminal ileum and proximal colon. Lialda and Apriso are formulated in a matrix that delays mesalamine release until it reaches the distal ileum and colon. Balsalazide, olsalazine and sulfasalazine are prodrugs that are cleaved in the colon following bacterial reduction to form mesalamine.  Pentasa is formed by packaging mesalamine in permeable microgranules. Permeable microgranules allow for mesalamine release throughout the intestinal tract.  Pentasa is more appropriate for Crohn's Disease because of its diffuse intestinal tract distribution. 

For ulcerative colitis, a Cochrane review showed no significant differences in the efficacy and safety of different formulations of Oral 5-ASA (5-aminosalicylic acid) used for induction and maintenance of UC (ulcerative colitis). 

As the patient had failed or had allergic reactions to formulary alternatives to all of the formulary alternatives (generic Apriso, balsalazide, and sulfasalazine), the requested Mesalamine is medically necessary. 

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient. 

As the patient had failed or had allergic reactions to formulary alternatives to all of the formulary alternatives (generic Apriso, balsalazide, and sulfasalazine), the requested Mesalamine is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Disturbances of Salivary Secretion. 
Treatment: CUVPOSA (glycopyrrolate) 1MG/ 5ML SOL. 

The insurer denied the CUVPOSA (glycopyrrolate) 1MG/ 5ML SOL. 
The denial is overturned. 

The patient is a female infant born at term via emergent cesarean section secondary to anhydramnios and fetal distress with severe hypoxic ischemic encephalopathy and neurologic impairment, seizures, and spasticity. She was treated with therapeutic hypothermia, anticonvulsant medications, antibiotics, and required non-invasive ventilation. She was reported to have weak suck, no gag, unable to fully protect her own airway, now status post gastrostomy tube placement and dependence. She is treated with routine Valium and gabapentin for spasticity. The current request is for glycopyrrolate to help control oral secretions. 

Yes, the CUVPOSA (glycopyrrolate) is medically necessary. 

This child was born in extremis via emergent cesarean section with no amniotic fluid, coated in meconium and purulent material. She suffered severe hypoxic ischemic injury with subsequent demonstration of the damage done on a variety of imaging studies. She has seizures as well as spasticity as a result, also known as "cerebral palsy." She has poor suck and no gag, indicative of an inability to protect her airway from secretions both from above and from reflux material. She is fully gastrostomy dependent. 

Glycopyrrolate is an anti-cholinergic agent that is used in multiple settings, including for management of secretions in patients with copious secretions and in those unable to protect their own airways from secretions. While it is approved for children older than three years of age, in the real setting, it is frequently used as standard of care in younger patients that lack airway protective abilities to help with secretion management. It is particularly useful in patients without tracheostomy because it is difficult to adequately suction away excessive secretions. Without some form of secretion management, these young patients are prone to aspiration events with subsequent pneumonia. Glycopyrrolate has been studied in children younger than three years of age and it has been demonstrated to be safe and effective in secretion management. Based on the current standard of care and this infant's clinical situation as documented in the medical record, use of glycopyrrolate (Cuvposa) is medically necessary and appropriate. 

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease. 
Treatment: Stelara 90 mg every 4 weeks. 
 
The insurer denied Stelara 90 mg every 4 weeks. 
The determination is overturned. 

The patient has anatomically extensive Crohn's disease. She failed Remicade (with an undetectable Remicade level, and anti-Remicade antibodies), and high-dose (weekly) Humira. She started on Stelara and was on Stelara 90 milligrams (mg) every 8 weeks. A colonoscopy showed active disease. She was increased to Stelara 90 mg every 4 weeks in and has been in remission since (confirmed on colonoscopy). At issue is the medical necessity of Stelara 90 mg every 4 weeks for the treatment of Crohn's disease. 
The requested Stelara 90 mg every 4 weeks is medically necessary in this case. 
Stelara is Food and Drug Administration (FDA)-approved for the treatment of Crohn's disease, and a large randomized controlled trial demonstrated safety and efficacy of Stelara for induction and maintenance of remission in patients with moderate-severe Crohn's disease [1-3]. Guidelines for the treatment of Crohn's disease recommend the use of Stelara [4]. In this case, the patient had initial improvement, followed by symptoms and objective evidence of active disease on colonoscopy. A study showed dosing intensification (90 mg every 4 weeks) was used frequently to address loss of response, and a large proportion of patients were able to maintain response [5-7]. One study showed that dose escalation was required and approximately half of patients, and successful in 61.1% of dose escalation attempts [5]. Another study showed efficacy of dose escalation to recover lost response in 73% of patients in whom it was attempted [7]. Additionally, American College of Gastroenterology guidelines for the treatment of Crohn's disease state that "Those with continued symptoms should...have their medication dose adjusted in order to attempt to optimize therapy" [4]. In this case, the patient has failed Stelara every 8 weeks, with active disease symptoms; dosing every 8 weeks or discontinuation of Stelara (even if an alternative therapy is attempted immediately) may result in complications such as fistula, stricture, bowel obstruction, flare, hospitalization, need for surgery, or other complications in this enrollee with moderate to severe (anatomically extensive) disease. The use of Stelara 90 mg every 4 weeks is supported as medically necessary for the treatment of Crohn's disease in this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Genitourinary/Kidney Disorder/Chronic Kidney Failure/ESRD. 
Treatment: Inpatient Hospital. 

The health plan denied the requested inpatient hospital stay as not medically necessary. 
The health plan's determination is upheld. 

The patient is a female with a history of end stage renal disease (ESRD) on hemodialysis, systemic lupus erythematosus (SLE) , deep vein thrombosis (DVT), chronic ascites, hypertension (HTN), sickle cell trait, and osteonecrosis of her bilateral hips who presents with nausea, vomiting, and abdominal pain for two days and a cough for two weeks. She denied headaches, chest pain, shortness of breath, constipation, or dysuria. She missed her last dialysis session due to not feeling well. Vitals showed that she was afebrile with a blood pressure (BP) of 191/121 millimeters of mercury (mmHg), a respiratory rate of 22/minute, a room air pulse oximetry of 100% and a pulse of 124 beats per minute (bpm). Her blood pressure improved in the emergency department (ED) to 127/88 mmHg with initiation of her home BP meds, in addition to intravenous (IV) Hydralazine and Labetalol. On exam, she was not in any acute distress, her abdomen was diffusely tender to palpation and distended. Her labs showed a white blood cell count (WBC) of 13.6, a hemoglobin of 9.2, a creatinine of 10.78, a blood urea nitrogen (BUN) of 77, a bicarbonate (HCO3) of 16 with an anion gap of 30, and a phosphatase of 10.1. A chest x-ray was unremarkable. An electrocardiogram (EKG) showed sinus tachycardia. She was admitted for further management. Nephrology was consulted for hemodialysis; interventional radiology was consulted for a paracentesis. She underwent hemodialysis. A chest computed tomography (CT) was also ordered to evaluate her cough and elevated WBC. The patient left against medical advice (AMA). 
At issue is the medical necessity of the inpatient hospital admission. 

I uphold in full, the health plan's determination of medical necessity. 

The inpatient admission was not medically necessary based on the documentation provided. The patient presented with nausea, abdominal pain, and a cough. She was hypertensive on arrival and her blood pressure responded appropriately to measures in the emergency room. The patient was not hypoxic or in respiratory distress; she did not have cardiac arrhythmias of clinical concern. She did not have uremic pericarditis, uremic encephalopathy, or uremic bleeding. The patient did not have severe metabolic or electrolyte abnormalities. She did have an elevated anion gap but there was not documentation of severe acidemia. The patient did not have a documented infection that required inpatient management. The patient did not have severe or persistent nausea, vomiting or changes in mental status. There was no other documented clinical indication that required inpatient management or monitoring. The patient could have been safely and effectively managed at a lower level of care such as an observation level of care with subsequent transition to outpatient follow up.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Testicular Hypofunction. 
Treatment: Pregnyl 1000UNIT IM SOLR. 

The insurer denied the Pregnyl 1000 UNIT IM SOLR. 
The denial is upheld. 

This male patient with hypogonadism has requested continued use of testosterone cypionate injections with Pregnyl injections.  He desires to maintain his fertility potential.  The testosterone level was 206 nanograms per deciliter (ng/dL).  The follicular stimulating hormone (FSH) was 1.6 and the luteinizing hormone (LH) was 5.56.  Endocrinology has recommended cessation of testosterone therapy. 

The Plan's reason for denial was " You must try the required number of preferred formulary alternatives (generic Delatestryl [prior authorization required]) and Testosterone gel 1.62% which requires Prior Authorization) on your formulary first. These drugs did not work for you or you cannot take them." 

No, the proposed Pregnyl is not medically necessary. 

The Plan requires use of preferred formulary alternatives (generic Delatestryl [prior authorization required], and testosterone gel 1.62% [prior authorization required]).  The patient has not tried either specific formulation of testosterone.  Delastestryl is testosterone enanthate. 

Yes, the health plan did act reasonably, with sound medical judgment and in the best interest of the patient. 

While limited data suggests that testosterone exogenously applied with Pregnyl can preserve spermatogenesis, the Prescribing Information for testosterone products warns about their adverse effect on spermatogenesis.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Vitiligo

Treatment: Topical 2% (percent) tofacitinib cream

The insurer denied coverage for topical 2% tofacitinib cream

The denial is overturned

The patient is a child with a diagnosis of vitiligo.  The patient has failed therapy with tacrolimus, Clobetasol, as well as UVB [ultraviolet-B] light therapy.  The requested medication is topical compounded tofacitinib 2% cream.  

Based on the submitted documentation, topical tofacitinib cream is medically necessary for the treatment of the patient's condition.  The patient has failed UVB light therapy as well as standard topical therapies, which would include topical steroids as well as non-steroidal option-tacrolimus ointment.  Vitiligo is an autoimmune disease and requires appropriate therapy.  The use of topical anti-inflammatory agents is within the standard of care prior to proceeding to systemic therapies with associated increased risks.  The use of topical tofacitinib under the supervision of the dermatologist is 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 compound topical 2% tofacitinib cream is overturned. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic obesity

Treatment: Saxenda 3 milligrams /0.5 milliliters (3 mg/0.5 ml)

The insurer denied coverage for Saxenda 3 milligrams /0.5 milliliters (3 mg/0.5 ml)

The denial is overturned

The patient has chronic obesity. She previously had done well on Saxenda. Her body mass index (BMI) is reported to be 38.3. Her other medical problems include attention deficit disorder, depression, and polycystic ovary syndrome.

The Food and Drug Administration (FDA) has listed indications for Saxenda. It is used as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with a BMI of 30 or greater. The contraindications include a family history of Multiple Endocrine Neoplasia syndrome type 2, hypersensitivity to the drug, and pregnancy.

The New England Journal of Medicine 2015: 373:11-22 article titled "A Randomized, Controlled Trial of 3.0 milligrams (mg) of Liraglutide in Weight Management" study involved a 56-week, double blind trial involving 3731 patients who had a BMI of at least 30, or a BMI of at least 27 for patients with dyslipidemia or hypertension. The conclusion was that liraglutide 3.0 mg as an adjunct to diet and exercise was associated with reduced body weight and improved metabolic control.

This patient has a BMI of 38. This meets the FDA indication of a BMI over 30 for giving Saxenda. It is supported by the results of a large double blinded trial of Saxenda. The health care plan did not act reasonably or with sound medical judgement. Saxenda 3.0 mg is medically necessary for this patient.

The insurer's denial of coverage for Saxenda 3 milligrams /0.5 milliliters (3 mg/0.5 ml) is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cystitis. 
Treatment: Inpatient Hospital Admission. 

The insurer denied coverage for inpatient hospital admission. 

The denial is overturned. 

The patient has a past medical history significant for growth delay who presented to the emergency department for complaints of right lower quadrant abdominal pain. Vitals on presentation included: Temperature max-98.6, blood pressure (BP)-107/59, pulse (P)-132, respiratory rate (RR)-22, oxygen saturation (O2 sat)-99% (percent). Laboratory results included the following: white blood count (WBC)-34.8, hemoglobin (Hgb)-13.7, hematocrit (Hct)-40.7, creatinine-0.4, glucose-93, urinalysis showed large leukocyte esterase and positive nitrites. The patient was started on intravenous fluids and empiric antibiotics (ceftriaxone). Computed tomography (CT) scan showed urinary bladder thickening suggestive of cystitis. Urine culture grew E. coli. (Escherichia Coli) WBC normalized. She remained afebrile, hemodynamically stable, and clinically stable. She was discharged on oral antibiotics (cephalexin) to follow-up as an outpatient. 

According to documentation, the patient presented with low-grade fever (100 Fahrenheit), tachycardia (132), and laboratory results were notable for leukocytosis (WBC-34.8), urine culture was positive for E coli. The patient was described as "ill-appearing and in pain." Based on the above findings, hospital admission was medically necessary for intravenous antibiotics and other diagnostic evaluation.  Prior determination of denial of acute level of care is overturned. 

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

The insurer's denial of coverage for the inpatient hospital admission is overturned. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Genitourinary/Kidney Disorder. 
Treatment: Inpatient Hospital. 

The insurer denied inpatient stay. 
The denial is overturned. 

The patient is a male who presented for pyeloplasty for right hydronephrosis with ureteropelvic junction (UPJ) obstruction. He was initially admitted for severe right lower back pain and multiple episodes of emesis. The pain occurred intermittently for two months with progressively increased intensity. His pain was up to 10 out of 10 in intensity. He had a computed tomography (CT) scan which showed a rental artery compression of the proximal ureter on the right side, with hydronephrosis. He also had a history of bradycardia which was evaluated and cleared by cardiology. 

His physical examination was significant for swelling of the right side of the back with mild tenderness with palpation of the lower lumbar region. An x-ray of the lumbar spine was obtained. He was treated with intravenous fluids as well as ceftriaxone and ketorolac for pain. He was not allowed to eat or drink and was scheduled for surgery. 
He underwent robotic pyeloplasty and tolerated the procedure well; a foley catheter and ureteral stent were placed. The foley catheter was removed, he was able to urinate without difficulty, and he was felt to be stable for discharge to home on oral antibiotics and with follow up as an outpatient. The subject under review is the medical necessity for the inpatient stay. 

The health plan's determination is overturned. 

This is a patient who presented after an episode of severe pain and recurrent emesis due to ureteropelvic junction (UPJ) obstruction. He was found to have significant hydronephrosis and warranted prompt surgical intervention to relieve the obstruction. He required preoperative intravenous fluids and monitoring, parenteral antibiotics, as well as appropriate pain management. Children who are symptomatic with UPJ obstruction require prompt operative intervention, particularly if radiographic evaluation reveals hydronephrosis. This patient's history of severe pain and emesis as well as hydronephrosis required prompt intervention with parenteral therapies in an inpatient setting. This would not have been appropriate for the outpatient setting. 
The decision making at the time of admission was consistent with his young age, the presence of UPJ obstruction requiring prompt surgical intervention, and the need for intravenous treatments as well as close monitoring for potential deterioration of clinical status.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Endocrine/Metabolic/Nutritional/Thyroid Problems. 
Treatment: Pharmacy/Prescription Drugs. 

The health plan denied the requested prescription drug Synthroid as not medically necessary. 

The health plan's determination is upheld. 

This is a male diagnosed with hypothyroidism. This request is for Synthroid. He states he was switched to the generic form and experienced pain and pressure on his eyes. He has been on Synthroid for a number of years, and it has worked fine. 
At issue is the medical necessity of the requested prescription drug, Synthroid. 

The health plan's determination of medical necessity is upheld, in whole. 

No. Brand name Synthroid is not medically necessary unless the patient has evidence of failure of generic Levothyroxine due to erratic thyroid hormone/ thyroid stimulating hormone (TSH) levels. The absorption of Levothyroxine can be erratic in a subset of patients [1, 2] but is generally good in the vast majority of patients who take it correctly on an empty stomach without other medications [3-6]. To date, no generic product accepted as equivalent using Food and Drug Administration (FDA) guidelines has been shown to result in a safety and efficacy profile different from its brand counterpart [7]. There is evidence that the patient has failed generic Levothyroxine. However, the patient has not tried brand name Levoxyl which is on the formulary or other formulations that are on the formulary. Brand name Synthroid is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Shortness of Breath. 
Treatment: Inpatient admission. 

The insurer denied the inpatient admission. 
The denial is upheld. 

The patient in this case is a female with history of metastatic non-small cell lung cancer. Her history was notable for prior brain metastases and also for pulmonary embolism and anticoagulation with Lovenox. The patient was seen in the emergency department (ED) with symptoms of shortness of breath and abdominal pain. She had been noted to have hypoxia with oxygen saturation in the 80s on room air. On initial evaluation, saturation was 94% and vital signs were unremarkable. It was noted that she had been on three liters of oxygen at home before this admission though she did note that shortness of breath and saturation worsened despite use of oxygen before the emergency department (ED) presentation. Evaluation also revealed significant elevation in liver enzymes compared to prior values. Computed tomography (CT) was done and revealed portal vein thrombosis. She was admitted and on the following day was discharged home.  It was noted that she was on a prednisone taper for prior immunotherapy related pneumonitis and this was continued.  She was also continued on Lovenox. 

No, the proposed inpatient admission was not medically necessary. 

This patient was admitted with symptoms of shortness of breath and abdominal pain.  She had hypoxia with activity which was felt to be possibly due to tumor progression.  She had a history of pneumonitis due to immunotherapy but computed tomography (CT) did not reveal any worsening of this process. Computed tomography revealed no acute changes in the lungs. The patient was diagnosed with portal vein thrombosis which was the explanation for her elevated liver enzymes. She was on Lovenox prior to admission and this was continued during and after admission. No change was made to management based on her portal vein thrombosis and she was also continued on oxygen after discharge. As the patient had no acute issues requiring hospital admission, and also did not have any interventions undertaken while in the hospital which would have required admission, the acute care inpatient stay in this case was not medically necessary. 

Yes, the health plan acted reasonably, with sound medical judgment and in the best interest of the patient.