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

Diagnosis: Abdominal Pain
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission.
The denial is upheld.

The patient presented with Right Upper Quadrant (RUQ) abdominal pain. The patient had a history of gallbladder disease and had a recent Endoscopic Retrograde Cholangiopancreatography (ERCP) and planned to have an elective cholecystectomy. The patient was afebrile, and the vital signs were stable. There were no peritoneal signs. There was no leukocytosis. An abdominal ultrasound showed cholelithiasis. There was elevation of the liver enzymes. The patient underwent a laparoscopic cholecystectomy. No complications were reported. 

Clinical indications for admission for Gallbladder or Bile Duct Inflammation or Obstruction (Milliman Care Guidelines (MCG) M-555) include having acute cholangitis or acute cholecystitis. These conditions need to be manifested by having systemic signs of inflammation in addition to gallbladder or bile duct disease. For acute cholecystitis, a cholecystectomy should not be anticipated during the current hospital stay. In this case, the patient did not have fever or leukocytosis. Other indications for admission include hemodynamic instability, severe vomiting, severe dehydration, severe pain, and bacteremia. The patient did not have these conditions. 

This patient had gallbladder disease but was not having systemic signs of inflammation. The patient required a laparoscopic cholecystectomy, but this could have been done as an ambulatory surgery. The patient did not meet MCG criteria for admission for Gallbladder or Bile Duct Inflammation or Obstruction. The health care plan acted reasonably and with sound medical judgment. An inpatient hospitalization was not medically necessary. The denial is upheld.

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: Overturned

Diagnosis:  Ankylosing spondylitis (AS).
Treatment:  Humira 40mg (milligrams) weekly.

The insurer denied coverage for Humira 40mg weekly.  The denial is overturned.

This case involves an adult patient diagnosed with ankylosing spondylitis, who is being recommended for the continued use of Humira.  The patient received a notice of adverse determination regarding Humira, stating that based on the information provided, the request is not approved.  The indication was that the patient tried and failed Humira given every other week and needed to increase the frequency to weekly.  The criteria for medical necessity were not met because the records submitted do not show that the patient meets criteria to include the Humira treatment is within the quantity of 2 syringes per 28 days (every other week).  An appeal was submitted stating that the patient has been treated for severe ankylosing spondylitis on biweekly Humira for several years.  He recently presented with mild pain and increasing hand stiffness with reports of diminished efficacy 7 days after his dose.  Symptoms would resolve after the injection, but at the current frequency of treatment, Humira was not working well enough to control severe symptoms.  The patient tried and failed ibuprofen, and it was considered imperative to allow the patient to continue treatment, which has been proven safe and efficacious for him over the years.  His QuantiFERON TB Gold plus was negative.  This review pertains to the denial of coverage for Humira 40 mg.

The Food and Drug Administration (FDA) states that Humira is indicated for multiple conditions to include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.  Patients are recommended to take 40 mg every other week or 80 mg every other week.  Literature has noted that for some patients with these conditions may require a dose escalation when they are no longer responding favorably to every other week dosing.  The records provided for the review noted that the patient had used Humira for years, and the medication was effective for the first week after administration. The patient was having diminished efficacy thereafter, and the Humira was failing to control the severe symptoms.  Dose escalation of Humira has been found to be safe and efficacious for the conditions listed within the Food and Drug Administration guidelines and given the patient's long-term use of the medication without adverse reaction, it would be appropriate to increase the dose to 40 mg every week to control his symptoms more effectively.  As such, the request for Humira 40 mg every week is considered medically necessary for this patient.

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 Humira 40mg weekly is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Migraine Headaches. 
Treatment: Botox. 
The health plan denied the requested prescription medication Botox, as not medically necessary. 
The health plan's determination is upheld. 

The patient is a man with chronic intractable migraine headaches. For his chronic migraine headaches, he is currently being treated with Emgality. However, despite treatment with Emgality, he continues to have frequent migraine headaches, which are occurring on an almost daily basis. In an attempt to improve the patient's headaches, his pediatric neurologist has prescribed Botox to be administered in addition to the Emgality. 
At issue is the medical necessity for the requested health service/treatment of Botox. 

The health plan's determination should be upheld, in whole. 

There is currently no strong published evidence demonstrating that the combination of Emgality and Botox is safe and effective for the treatment of patients with chronic migraine headache. Therefore, in the absence of this evidence, Botox for this patient cannot be considered medically necessary. 

Botulinum toxin (Botox) is a molecule produced by the bacterium Clostridium botulinum.  When injected into patients with chronic migraine headaches, it can reduce the frequency and severity of the migraine headaches. Emgality is a monoclonal antibody directed against calcitonin gene-related peptide (CGRP), which is a molecule that plays an important role in the generation of migraine headaches. By binding to CGRP, Emgality blocks the ability of CGRP to bind to its receptor and, thus, can prevent migraine headaches. Some patients continue to get migraine headaches, despite treatment with Botox or Emgality. Several studies have been published suggesting that the combination of Emgality and Botox might be superior to treatment with either medication alone for some patients. However, these studies have not been large-scale double-blind, placebo-controlled studies. Instead, these studies have consisted of small numbers of patients and have been case series and retrospective chart reviews. Thus, these limited publications cannot be considered strong evidence that the combination of Emgality and Botox is safe and effective for the treatment of patients with chronic migraine headache.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Flank Pain, hematuria
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The determination is overturned.

This is a male patient with a past medical history (PMH) of asthma and bilateral lung apical blebs status/post (s/p) left thoracostomy who was admitted with complaints of (c/o) a three-day history of bilateral flank pain associated with hematuria. The vital signs were unremarkable. The physical exam was notable for moderate discomfort, positive costovertebral angle (CVA) tenderness. Lab work was notable for creatinine 1.67-1.74, leukocytosis, urinalysis (UA) with (w/) positive (+) leukocyte esterase (LE). Imaging studies included a computed tomography (CT) scan of the abdomen/pelvis (A/P) which showed mild right hydronephrosis with perinephric stranding and possible ureteral stone, a chest x-ray (CXR) which showed no acute cardiopulmonary disease, computed tomography (CT) urogram that showed delayed right nephrogram and delayed excretion by right kidney with a 3 millimeter (mm) right obstructive ureteral stone. The patient was diagnosed with a urinary tract infection (UTI)/pyelonephritis and obstructive ureteral stone and treated with intravenous fluids (IVF), pain control, Flomax, and antibiotics. The patient experienced scant hematochezia during the hospital stay and was recommended for an outpatient gastroenterology (GI) evaluation. Urology evaluated the patient and recommended no acute surgical intervention. The patient was discharged in stable condition. At issue is the medical necessity of an inpatient level of care.

The hospital stay was medically necessary at an inpatient level of care.

This patient presented to the emergency department (ED) with leukocytosis, urinary symptoms, and evidence of a urinary tract infection. He was provided with intravenous antibiotics and hydration, to which the patient responded well. He had leukocytosis, clinical evidence of pyelonephritis, and moderate distress/significant pain, increasing the clinical risk of monitoring this patient at a lower level of care than inpatient, especially given the presence of an obstructive stone, acute kidney injury, and concomitant hydronephrosis. He required close monitoring, aggressive intravenous (IV) hydration, intravenous antibiotics, and cultures to ensure that his sepsis was adequately controlled, his creatinine was improving, and that he did not become more hemodynamically unstable. Overall, this patient required an inpatient level of care.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Irritable Bowel Syndrome with diarrhea
Treatment: Viberzi 75mg (milligram) Tablet
The insurer denied: Viberzi 75mg (milligram) Tablet
The denial is overturned

The patient is an adult male with IBS-D (Irritable Bowel Syndrome with Diarrhea). He has failed loperamide and Xifaxan. His treating provider is requesting treatment with Viberzi. Viberzi was denied, as the patient has not failed lotronex. 

The health plan should cover Viberzi. 

As the patient has failed the only two plan preferred agents, loperamide and Xifaxan, that are FDA (Food Drug Administration) approved for use in men with IBS-D (Irritable Bowel Syndrome with Diarrhea), there are no other preferred formulary agents that have been shown to be as effective as Viberzi in men. Lotronex is not FDA (Food Drug Administration) approved or supported by compendia or medical literature in men with IBS-D (Irritable Bowel Syndrome with Diarrhea). Therefore, the health plan should cover the requested Viberzi.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Systemic lupus erythematosus (SLE).
Treatment: Sotyktu 6 mg (milligram) tablet.
The insurer denied: Sotyktu 6 mg (milligram) tablet.
The denial is upheld.

The patient is an adult female with systemic lupus erythematosus, treated with systemic and topical corticosteroids, and antihistamines. The clinical documentation also indicates she has folliculitis. The provider is requesting Sotyktu. The health plan denied the request as this is not a Food and Drug Administration (FDA) or compendia supported indication.

The proposed treatment is not medically necessary.

Sotyktu is not Food and Drug Administration approved folliculitis. In addition, while Sotyktu has been investigated in a randomized controlled trial for lupus, it is not currently Food and Drug
Administration (FDA) approved for this diagnosis and the patient has not tried other standard, approved treatments for her condition. Standard treatments include Plaquenil, chloroquine and methotrexate. Systemic lupus erythematosus (SLE) is generally managed by Rheumatologists. 
In the trial by Morand et al, adults with active systemic lupus erythematosus were enrolled from 162 sites in 17 countries. Patients (n = 363) were randomized 1:1:1:1 to receive deucravacitinib 3 milligrams (mg) twice daily, 6 milligrams twice daily, 12 milligrams once daily, or placebo. At week 32, the percentage of patients achieving Systemic Lupus Erythematosus Responder Index (SRI-4) response was 34% with placebo compared to 58% with deucravacitinib 3 milligrams twice daily, 50% with 6 milligrams twice daily, and 45% with 12 milligrams once daily.
Therefore, given that Sotyktu is not Food and Drug Administration approved for folliculitis or systemic lupus erythematosus, it is not medically necessary.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Elevated BMI (body mass index), hyperlipidemia
Treatment: Formulary exception for Wegovy
The insurer denied: Formulary exception for Wegovy
The denial is upheld

The patient is an adult female with obesity and hyperlipidemia. The request for Wegovy is under review. The prior request was denied coverage by the health plan, because Wegovy is a non-formulary drug. Per the health plan's denial, "You must have tried and failed two of our formulary alternatives or your prescriber must send us a statement explaining why you cannot take the alternative drugs on our formulary. Formulary alternatives include phentermine, benzphetamine, diethylpropion, phendimetrazine." The denial is being appealed. The patient's body mass index is 36.7. The patient has tried a sample for one month, resulting in a 2-pound weight loss.

The health plan should not cover the formulary exception for Wegovy.

This request is for Wegovy for the treatment of obesity. This patient has an elevated body mass index of 36.7 and hyperlipidemia. The formulary alternatives include phentermine, which is safe and effective for the treatment of obesity. No medical reason was provided to use Wegovy over phentermine, such as a diagnosis of type 2 diabetes or prediabetes. The patient does not have a documented trial of the formulary alternatives or a documented contraindication to the formulary alternatives. Therefore, no, the health plan should not cover the formulary exception for Wegovy.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Functional Deficits
Treatment: Reallocation of Personal Care Aide (PCA) services Level 2: from 5 hours per day 7 days per week to 7 hours per day - 5 day(s) per week - for a total of 35 hours per week 
The insurer denied: Reallocation of Personal Care Aide (PCA) services Level 2: from 5 hours per day 7 days per week to 7 hours per day - 5 day(s) per week - for a total of 35 hours per week 
The denial is: Overturned

The patient is a female with medical history notable for functional deficits. The patient is currently approved for 5 hours per day, 7 days per week (35 hours per week) of personal care services. The patient and her care team requested a change to 7 hours per day, 5 days per week (35 hours per week) and this request was denied by the health plan. This denial is the subject under review.

The patient's daughter provided a letter of support for this appeal. The letter states that although the health plan claims that a family member is always with the patient, this is not true; the patient's daughter works from 9-5 during the week and cannot be present to assist. She has a history of 3 falls in the last year (with injuries including lacerations and fractures of her hip and femur) when attempting to perform functional activities on her own.
The patient's physician provided a letter of support for this appeal. The letter states that the patient is unable to care for herself and needs additional hours to cover her needs. No further details are provided.
A Uniform Assessment System (UAS) was completed and was available for review. The assessment was conducted in person with the patient's daughter present. The patient's cognition is independent and she was oriented times three. Recall was 1/3 after five minutes. For her Instrumental activities of daily living (IADLs), she requires total dependence for meal preparation, housework, finances, and transportation. She requires maximal assistance for shopping. For her activities of daily living (ADLs), she requires extensive assistance for dressing lower body, walking, locomotion, toilet transfer, and toilet use. She is frequently incontinent of urine and uses 4 pull-ups per day. A task tool recommended 35 hours per week to address her personal care needs.

The health plan's determination is overturned.

The requested health service of Personal Care Aide (PCA) services Level 2: from 5 hours per day 7 days per week to 7 hours per day - 5 day(s) per week - for a total of 35 hours per week is medically necessary for this patient.
The patient has requirement of extensive assistance for transfers and toileting. She has a great amount of informal support from family, but they are not able to care for her during the workday. Her prior falls with resulting injuries when attempting to perform personal care tasks alone are evidence of unmet personal care needs. If the family cannot be there during the workday, then it is medically necessary for her to have a personal care aide to meet her unmet and unscheduled personal care needs.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Immune-mediated necrotizing myopathy. 
Treatment: Inpatient acute rehabilitation. 

The insurer denied coverage for inpatient acute rehabilitation. 

The denial is upheld. 

This is an adult who presented to the hospital with lower extremity pain and weakness. She was treated with intravenous immunoglobulins (IVIG) for diagnosed immune-mediated necrotizing myopathy. She was subsequently transferred to an acute rehabilitation facility. 

The patient was appropriately admitted for acute rehabilitation. She participated in a multidisciplinary rehabilitation program with documented functional improvement. According to the Team Conference Note, the patient was ambulating more than 100 feet with a rolling walker and minimal assistance. The physical therapy progress note indicates the patient was ambulating with a rolling walker and only contact guard assistance. A similar level of progress was documented by the occupational therapist. The occupational therapy progress note documents the patient at the supervision/modified independent level for grooming, hygiene and transfers. Wound care at the biopsy site was routine by this time. There were no longer acute medical or complicated nursing issues that warranted acute inpatient rehabilitation for eight days. Treatment could have safely been provided at a lower level of care. 

From a physical medicine and rehabilitation perspective the clinical records show that continued admission was not supported. 

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 continued admission is not substantiated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Gastroesophageal reflux disease. 
Treatment: Dexlansoprazole Delayed- Rel (release). 

The insurer denied coverage for Dexlansoprazole Delayed- Rel (release). 

The denial is upheld. 
 
The patient has a diagnosis of esophageal reflux disease and Barrett's esophagus. The diagnosis code that was submitted was for K21.9 which is Gastroesophageal reflux without esophagitis. It is reported that the patient has been on Dexilant (Dexlansoprazole Delayed- Rel (release)) for several years and that previously multiple other medications had failed. The submitted information for review does not specify which medications have been tried and failed. The formulary alternatives include esomeprazole, lansoprazole, pantoprazole, and omeprazole. 

UpToDate has an article titled "Proton pump inhibitors (PPI): Overview of use and adverse effects in the treatment of acid related disorders." The article states that PPls are similar in structure and mechanism of action although there are differences. However, the magnitude of these differences is small, and their clinical relevance has not been established. A systematic review of 12 randomized trials examining the relative effectiveness of different PPI doses found no consistent difference in symptom resolution and esophagitis healing rates. 

This patient has a diagnosis of gastroesophageal reflux disease and giving a PPI is appropriate. However, the information that was submitted for review does not show that the patient has tried and failed the multiple PPI medications that the insurance company has offered. The Up To Date article does not support the assertion that one PPI is superior in esophageal healing as compared to the others. The formulary drugs are not likely to cause an adverse reaction. The medical record does not document which PPls have been tried and failed. It has not been shown that Dexilant is more effective than the other proton pump inhibitors. 

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 carrier's denial of Request for Formulary Exception for Dexlansoprazole Delayed- Rel is upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: ureteropelvic junction (UPJ) stone
Treatment: inpatient admission
The insurer denied: inpatient admission
The denial is: overturned

The patient is a female with a history of chronic left (L) obstructing ureteropelvic junction (UPJ) stone who presented with left sided abdominal and back pain of one day duration. She denied fevers or chills, stated her pain was 7/10 and associated with vomiting. She also reported hematuria but denied dysuria or urinary retention. Vitals signs showed that she was afebrile with a blood pressure of 110/51, a pulse of 86, a respiratory rate of 18 and a pulse oximetry of 98%.
Labs showed a white blood cell (WBC) count of 9 and a creatinine of 0.8. A urinalysis showed large blood, positive (+) urine nitrite, trace leukocyte esterase and many bacteria. Her exam was positive for left costovertebral angle tenderness. A computed tomography (CT) scan showed chronic left UPJ stone with worsening severe left hydronephrosis, perinephric and periureteral stranding. A delayed nephrogram of the left kidney was compatible with delayed renal function. She was given Ofirmev, Toradol and intravenous (IV) fluids. In addition, she was given IV cefepime and IV vancomycin due to concerns of possible infection. Urology was consulted and a decision was made to admit the patient for a possible nephrostomy tube and stent placement. She underwent an interventional radiology (IR) left nephrostomy tube placement. The patient was discharged home in stable condition. The subject under review is the medical necessity for the inpatient admission.

The inpatient admission was medically necessary based on the documentation provided. The patient presented with left sided renal colic in the setting of a known left UPJ kidney stone. Her urinalysis and CT imaging were concerning for concomitant acute pyelonephritis. Pyelonephritis in the setting of a known urologic abnormalities is an indication for inpatient admission. It was reasonable given her presentation, laboratory and imaging findings to admit to an inpatient level of service anticipated that she would likely require inpatient monitoring and treatment of this complex condition.