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

Diagnosis: Acute Kidney Injury

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission

The denial is upheld

This case involves an adult patient who presented to the Emergency Department with complaints of worsening right flank pain and nausea. The patient reported being able to urinate with blood in the urine. The patient stated to have been seen the day prior for kidney stones. The patient reported taking Percocet with little relief. Computed Tomography (CT) scan noted mild right hydronephrosis and moderate perinephric stranding. The patient was recommended for admission. History and physical reported the patient was admitted having acute kidney injury and possible urinary tract infection. Treatment plan was for consultations and labs. Urology consultation reported the patient was clear for discharge with oral antibiotics. Nephrology consultation recommended follow-up with primary nephrologist in 1 week. The patient was discharged the day after admission. The appeal letter reported the prior hospitalization was denied. The facility was requesting an appeal as the admission was clinically and medically necessary. The patient was admitted with a diagnosis of acute kidney injury. It was noted that the CT findings had increased since prior exam and treatment included IV medications as well as urology and nephrology consult. The Final Determination Letter reported the prior denial of hospitalization was upheld. It was noted that the patient was not unstable in the hospital stay and was approved at an observation level of care.

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

Milliman Care Guidelines (MCG) recommends inpatient admission for kidney stones when a patient has hemodynamic instability, acute kidney injury (stage 2), acute renal failure (stage 3 acute kidney injury), bilateral obstruction, obstruction with single functioning kidney, transplanted kidney with obstruction, severe pain requiring acute inpatient management, vomiting that is severe or persistent, urinary tract infection, need for IV hydration support despite observation care, and/or stone removal procedure needed requiring inpatient admission. In this case, the patient had a known kidney stone with complaints of right flank pain. The patient could have been treated at an observational level of care. There was no instability or severe condition to warrant inpatient admission. As such, the inpatient admission is not considered medically necessary for this patient.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for the inpatient admission is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal pain, nausea, vomiting
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is upheld

This patient is an adult female. She presented to the ED (emergency department) with the complaint of abdominal pain and vomiting of one-day duration. The patient's examination revealed epigastric tenderness. Vital signs identified a normal temperature and normal vital signs at the time of presentation. The WBC (white blood cell) count was elevated at 12 K (thousand). Surgical consultation was obtained with tenderness noted in the right lower quadrant. CT (computed tomography) scan was completed showing findings of a 9-mm (millimeter) appendix without surrounding peri appendiceal fat stranding.
The patient was admitted to the hospital and started on IV (intravenous) antibiotics. The next day the patient underwent laparoscopic appendectomy. She was monitored following surgery and remained stable. She was discharged from the instructions for surgical follow-up. The health plan's rationale for denial of coverage of the inpatient admission is that there is no documentation of need for an inpatient level of care and the care rendered could have been provided without admission to the hospital. The hospital appeal letter references MCG (Milliman Care Guidelines) 26th General Admission Criteria.

Inpatient care was not medically necessary. 

This patient presented to the ED (emergency department) and was evaluated with physical exam, labs and imaging that supported the diagnosis of acute appendicitis. She was treated initially with NPO (nothing by mouth) status, IV (intravenous) fluid and IV (intravenous) antibiotics. The patient underwent laparoscopic appendectomy. Her clinical course was without adverse incident. The patient responded favorably to this treatment and the hospitalization was uncomplicated. The patient had no comorbid health conditions that mandated an inpatient level of care, and the vital signs were consistently normal. The medical records document clinical stability without complication during this period of monitoring.
The submitted clinical documentation does not support the need for inpatient admission for this patient. A lower level of care would have satisfactorily provided for the care provided and would have been consistent with the accepted standard of medical care.
Generally accepted medical standards indicate that in the absence of hemodynamic instability, sepsis or toxicity, significant electrolyte imbalance, bleeding, GI (gastrointestinal) obstruction or surgical complications, treatment as provided in this case could be provided without an inpatient level of care. In this case, the patient tolerated oral hydration following surgery. A lower 
level of care would have appropriately provided for treatment and overnight monitoring. Inpatient care was not required or medically necessary in this case per generally accepted medical standards.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hypoglycemia
Treatment: Gvoke HypoPen
The insurer denied coverage for Gvoke HypoPen
The denial is upheld

The patient is an adult with history of Gastric Bypass. The patient is doing better; she is working with an endocrinologist. The patient is currently on continuous glucose monitor. She was started on Acarbose, and blood glucose readings remained in the 70's. The patient is having frequent small meals. The provider prescribed the patient Gvoke hypopen 2-pack 1 mg (milligrams) /0.2 ml (milliliter) Auto Injection 2.8 for 30 days.

Per appeal information, the patient requires more than two doses/30 days for intermittent hypoglycemia. The patient cannot take oral glucose due to a history of gastric bypass and onset of action not fast enough.

No additional kits of Gvoke HypoPen are medically necessary. Per provider notes the claimant uses on average two shots per week of the glucagon (Gvoke) pen. The requested 14 pens greatly exceed the clinical data provided. In addition, the pen is mostly used for emergencies and not routine usage.

As described in Up to Date, there are other approaches to management of this complication of bariatric surgery. 

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 additional kits (doses) of Gvoke HypoPen monthly; quantity limit exception is not substantiated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Osteoporosis
Treatment: Forteo
The insurer denied coverage for Forteo
The denial is upheld

According to the records, the patient is an adult with osteoporosis who has severe spinal disease and history of prior fracture. Her Endocrinologist recommends either Forteo or Tymlos to help increase her bone density.  

According to the insurer, an alternative on the formulary list is Tymlos. The patient must try one alternative if there is only one covered alternative. The requested medication is denied based on the plan approved criteria Forteo, Teriparatide, Bonsity Marketplace.

The formulary drug is not likely to cause the patient an adverse reaction. The patient can use Tymlos.

The formulary drug has not been ineffective based on the patient's clinical history. 

The requested drug is not more effective than the formulary drug. 

According to the Tymlos Prescribing Information, "TYMLOS is a human parathyroid hormone related peptide analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture."

According to the Medical Letter (2017), "The Food and Drug Administration (FDA) has approved abaloparatide (Tymlos Radius Health), a synthetic analog of human parathyroid hormone related peptide, for treatment of postmenopausal women with osteoporosis who are at high risk for fracture. Abaloparatide is the second parathyroid hormone receptor agonist to be approved for this indication; teriparatide (Forteo Lilly), a recombinant parathyroid hormone analog, was the first. They are the only drugs approved for treatment of osteoporosis that stimulate bone formation. Other drugs used for this indication inhibit bone resorption".

Lastly, Shirley et al (2017) states, "Abaloparatide (Tymlos) is a synthetic peptide analogue of human parathyroid hormone-related protein that was developed by Radius Health as an osteoanabolic agent for the treatment of postmenopausal osteoporosis. Abaloparatide acts through selective activation of the parathyroid hormone type 1 receptor signaling pathway. In April 2017, subcutaneous abaloparatide received its first global approval, in the USA (United States of America), for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy."

The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.
The formulary drug is not expected to be ineffective.

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

The carrier's denial of Request for Formulary Exception for Forteo to treat osteoporosis is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Wound infection
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The determination is upheld.

This is a female patient with a past medical history (PMH) of substance abuse, generalized anxiety disorder (GAD), major depressive disorder (MDD), and self-mutilation who was admitted with complaints of (c/o) back and shoulder pain secondary to a wound infection. The physical exam was notable for a large erythematous/pink ulcerated wound on the left upper back. Lab work was notable for urine drug screening (UDS) with (w/) amphetamine and benzodiazepines (BZDs). The patient was diagnosed with cellulitis and treated with intravenous (IV) antibiotics, intravenous fluids (IVF), and pain control. Surgery was consulted and recommended not picking the wounds and applying calcium alginate. The patient was discharged in stable condition. At issue is the medical necessity of an inpatient level of care.

The hospital stay was not medically necessary at an acute inpatient level of care. The patient presented to the emergency department (ED) with complaints of (c/o) back and shoulder pain secondary to a wound infection. The patient was afebrile, did not appear toxic, had no unstable comorbidities, did not have a limb-threatening infection, there was no septicemia, life-threatening infection, necrotizing fasciitis, leukocytosis, features of systemic inflammatory response syndrome (SIRS), animal or human bite with extensive damage, high risk location (face, neck, hand, genitals), pain out of proportion to clinical findings, crepitus, neutropenia, immune-suppression, marked systemic toxicity or worsening symptoms, or inability to take oral medications. This patient was treated with IV antibiotics and quickly switched to oral antibiotics, and there was no required surgical intervention, and these interventions could have been safely provided at an observation level of care. Observation is ideal for the management of mild cellulitis infections because it allows frequent reevaluation to assess response to therapy while avoiding inpatient admission. Overall, this patient could have been safely treated at a lower level of care.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Ulcerative Colitis. 
Treatment: Avsola. 
The insurer denied Avsola. 
The health plan's determination is upheld. 

This patient is a female with a history of ulcerative colitis. She previously tried and failed mesalamine and required hospitalization. She was started on infliximab during her recent hospital stay and received one dose. 

Under review is Avsola (infliximab). 

A formulary exception is not indicated in this case. There is no evidence that the formulary alternatives would not be effective in this case or would have increased risk of adverse events. 

The formulary list includes Humira, Stelara, Xeljanz and Rinvoq, which are all Food and Drug Administration (FDA) approved for treating ulcerative colitis in adults and proven to be safe and effective. 

There is no evidence that Avsola is superior to all of the formulary alternatives in terms of safety or efficacy. The records do not clearly indicate that the formulary alternatives would be ineffective or inappropriate in this case. 

Therefore, the patient can be treated with the formulary alternatives safely and effectively.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Ankylosing Spondylitis.
Treatment: Formulary Exception for Simponi 50mg (milligrams) / 0.5ml (milliliter) Syringe.
The insurer denied: Formulary Exception for Simponi 50mg (milligrams) / 0.5ml (milliliter) Syringe.
The denial is overturned.

The patient is an adult male with a diagnosis of ankylosing spondylitis. His rheumatologist wants to start Simponi. Simponi was denied as the patient had not tried and failed or had serious side effects or drug with all of the formulary medications: ibuprofen, naproxen, meloxicam, celecoxib, Nabumetone, Enbrel, Humira, Cosentyx, Cimzia, and Xeljanz. 
The patient's rheumatologist is appealing the denial as the patient has previously tried and failed Ibuprofen, naproxen, diclofenac, sulfasalazine, Humira, Enbrel, Cimzia, infliximab, Cosentyx. Methotrexate and leflunomide are being avoided due to underlying liver disease. Xeljanz is contraindicated as patient has diverticular bowel perforation. Simponi is the only option for 
treatment of patient's ankylosing spondylitis. 

The health plan should cover the proposed treatment. 

The patient has tried all the formulary agents and either had contraindications or were ineffective as per documentation provided. The patient has contraindications to methotrexate and 
leflunomide and has tried all the rest of the formulary, so there is no further choice other than Simponi. 
The remaining formulary drugs will have adverse effects on this patient. Methotrexate and leflunomide can cause liver enzymes elevation and further damage to patients who have already have an underlying liver disease. Xeljanz can cause diverticulitis and bowel perforation. This patient already has history of diverticulitis causing bowel perforation. Hence starting the patient on Xeljanz will increase his chances of for further bowel perforation. 
Therefore, given the resistant disease of ankylosing spondylitis in this patient who has failed almost all the alternative formulary treatments, and has contraindication to others, the next best option would be a trial of Simponi. Recommended duration of approval 12 months.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alzheimer's dementia

Treatment: Personal Care Aide (PCA) services, 12 hours per day, 7 days a week, 12 hours per day, 7 days a week (split shift) for a total amount of 168 hours per week

The insurer denied coverage for Personal Care Aide (PCA) services, 12 hours per day, 7 days a week, 12 hours per day, 7 days a week (split shift) for a total amount of 168 hours per week

The denial is overturned

 
This is an elderly patient with progressive Alzheimer's dementia. The insurer approved personal care aide (PCA) live-in services, 7 days/week and the request is for PCA services 2-12 hour split shift, 7 days a week, which is under review.

The Uniform Assessment System (UAS) report was reviewed. The patient's cognition is "Severely impaired." She is totally dependent for Instrumental Activities of Daily Living (IADL) tasks including meal preparation, ordinary housework and shopping.  She is totally dependent for bathing, personal hygiene, dressing, locomotion and toilet use. Maximal assistance is needed for bed mobility, ambulation and toilet use. Extensive assistance is needed for eating. She is incontinent of bowel and bladder. Her functional capacity has declined compared to the prior UAS report.

The patient's medical condition: essentially total dependence for most of her IADL and ADL (activities of daily living) tasks are at a level or unpredictable as to require the requested PCA services 24 hours/day, 7 days/week (split shift). Based on the records reviewed, the currently approved live-in PCA is unlikely capable of providing for the patient's functional needs while having the ability to consistently obtain uninterrupted 5 hours of sleep. The patient is at particularly high risk for falls, bed sores and joint contractures.  he patient's health and safety are more appropriately provided and maintained at home with the requested PCA services 24 hours/day, 7 days/week split shift.

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 Personal Care Aide (PCA) services, 12 hours per day, 7 days a week, 12 hours per day, 7 days a week (split shift) for a total amount of 168 hours per week is substantiated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Type 2 Diabetes
Treatment: Vascepa 1 g (gram) soft gel capsule
The insurer denied coverage for Vascepa 1 g soft gel capsule
The denial is upheld
 
The patient is an adult with medical diagnoses of Type 2 diabetes mellitus, hypertension, and hyperlipidemia. The provider is appealing to obtain coverage for Vascepa 1 gram capsule. 

It was the patient's physician who noted that Vascepa is indicated as an adjunct to maximally tolerated statin therapy to reduce risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adults with elevated Triglyceride levels [150 mg (milligrams)/dL (deciliter)], and Diabetes mellitus and two or more additional risk factors for cardiovascular disease. The alternatives that are required to be tried first do not have the cardiovascular benefit that Vascepa does. This patient is already successfully established on the medication and changing to any alternative medications would not benefit this patient.

The insurer received a formulary exception request for coverage of Vascepa 1g Soft Gel Capsule for use in the treatment of Type 2 diabetes mellitus with hyperglycemia. The request was denied because the policy states that this medication may be approved if the member had an adverse reaction to the generic drug and the adverse reaction was due to an inactive ingredient. Formulary alternative(s) are icosapent ethyl; omega-3-acid ethyl esters capsule. Requirement: 3 in a class with 3 or more alternatives, 2 in a class with 2 alternatives, or 1 in a class with only 1 alternative.

The formulary drug is not likely to cause the patient an adverse reaction. 

Vascepa is the Brand name for icosapent ethyl. As per Lexicomp, a generic version of this medication is available. There is no reason to consider the generic version less effective in providing the benefits seen with Vascepa since the generic version is also Food and Drug Administration (FDA) approved. Note that the insurer formulary lists icosapent ethyl. 

There is no documentation that the claimant has tried and failed the generic version.

The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is not expected to be ineffective.

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

The carrier's denial of Request for Formulary Exception for Vascepa 1 gram (g) soft gel capsule is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Alopecia areata.
Treatment: Xeljanz 5MG (milligrams).
The insurer denied: Xeljanz 5MG (milligrams).
The denial is upheld.

The patient is a school-aged female with alopecia areata, treated with topical anthralin. The provider is requesting Xeljanz. The health plan denied coverage as the medication is not Food and Drug Administration (FDA) approved for this diagnosis.

The proposed treatment is not medically necessary.

The health plan denied coverage as the medication is not Food and Drug Administration approved for this diagnosis. Baricitinib (Olumiant) is now Food and Drug Administration approved for alopecia areata. Xeljanz is not Food and Drug Administration approved for this diagnosis. Barcitinib is approved for use in children (for COVID19), while Xeljanz is approved for ages two and up for arthritis. Ruxolitinib and upadacitnib are only approved for ages 12 and up. Xeljanz is not Food and Drug 
Administration approved for alopecia areata. Therefore, Xeljanz is not considered medically necessary at this time as it is not Food and Drug Administration approved for this patient population.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Facial droop/weakness.
Treatment: Inpatient stay.
The insurer denied the inpatient stay. 
The health plan's determination is upheld. 

The patient is a female with a past medical history significant for asthma, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea on bi-level positive airway pressure (BiPAP), hyperlipidemia, obesity, gastroesophageal reflux disease (GERD), IBS irritable bowel syndrome), diverticulitis, hypothyroidism, fibromyalgia, and chronic fatigue syndrome who presented to the hospital with right-sided neck weakness and right-sided facial droop. The patient reported a history of right-sided neck nerve ablation. The patient also stated that she went to see a chiropractor who was concerned about her right facial droop. She was instructed to come to the emergency department for further evaluation. The review of systems was negative for paresthesias, numbness, fever, or chills. The patient denied chest pain.

No, the acute inpatient level of care was not medically necessary. There was no evidence that the patient's symptoms were related to central nervous system (CNS) infection. The patient's symptoms were not associated with altered mental status. The imaging studies did not demonstrate any significant abnormalities. There were no clear indications that the patient had myasthenia gravis crisis, acute exacerbation of multiple sclerosis, or other demyelinating diseases. There was no mention that the patient had intracranial hypertension, mass, amyotrophic lateral sclerosis (ALS) with acute complications, neurologic trauma, or any other condition that would require admission at the acute inpatient level of care. Taking into consideration all these facts, admission for observation seems to be most reasonable, given the clinical circumstances.