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

Diagnosis: rheumatoid arthritis

Treatment: Kevzara 200 milligrams (mg)/1.14 pen injector

The insurer is denied coverage for Kevzara 200 milligrams (mg)/1.14 pen injector.

The denial is overturned. 

This female patient has a history of rheumatoid arthritis (RA) and hypothyroidism.

The patient has active RA with a history of multiple drug failures. One of the two suggested formulary drugs is an anti-TNF [tumor   medication (Cimzia). She has already failed two (Enbrel, Humira). As noted in UpToDate, "Treatment of rheumatoid arthritis in adults resistant to initial biologic DMARD [disease modifying antirheumatic drug] therapy" there is no value in trying a 3rd anti-TNF if two fail. 

The other is a JAK [Janus kinase] inhibitor. She has already failed one, and this increases the odds that another will fail as well.

The patient had success in the past with Actemra, an anti-IL-6 medication. It was stopped due to pregnancy and did not work when re-introduced. Kevzara is another anti-IL6 medication. Given that there were no side-effects from Actemra, the same should be expected for Kevzara. The chances it will work are lessened by the eventual past failure of Actemra. But the Kevzara could get around the blocking mechanism and work as the Actemra did. It is more likely to work than Rinvoq, which had failed from the start.

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

The carrier's denial of coverage for the Kevzara 200 milligrams (mg)/1.14 pen injector is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Congestive heart failure, dementia and hip
fracture
Treatment: Increase Home Care/Personal Care HHC to 24 Hours Per Day (Live-In)
The insurer denied the Increase Home Care/Personal Care HHC to 24 Hours Per Day (Live-In)
The denial is overturned.

The patient is a female with a history of congestive heart failure, dementia and hip fracture status post open reduction internal fixation (ORIF). Due to impairments related to these conditions, she requires assistance for completion of the majority of her activities of daily living (ADLs). Appeal review requested for potential approval of an increase in home care/personal care HHC to 24 hours per day (live-in) to offer increased activities of daily living (ADLs) support.

Yes, the proposed treatment of 24 hours per day (live-in) personal assistance services is deemed medically necessary.
This is a female with a history of congestive heart failure, dementia and hip fracture status post open reduction internal fixation (ORIF). Due to impairments related to these conditions, she requires assistance for completion of the majority of her activities of daily living (ADLs).  Although an assessment of the patient's functionality and ability to perform activities of daily living (ADLs) was completed and revealed that the currently approved plan of 70 hours per week personal assistance services is sufficient to meet the patient's current needs; the patient's medical provider, relates this reduced schedule leaves the patient home alone, completely unassisted for numerous hours a day. This is problematic as she requires assistance with bed repositioning every two hours, transfers, ambulance, toileting, dressing, meal preparation, medication management, grocery shopping and housework. 

Hence, provision of 24 hours per day (live-in) personal assistance services can reasonably be expected to be beneficial for the patient and withholding these services, in whole or in part, can reasonably be expected to affect the patient's health adversely. For these reasons, the proposed treatment of 24 hours per day (live-in) personal assistance services is deemed medically necessary.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Migraines.
Treatment: Formulary exception for Ubrelvy, Pre-service.
The insurer denied the Formulary exception for Ubrelvy, Pre-service.
The denial is overturned.

The patient is a female with migraine headache disorder. She has tried and failed sumatriptan, rizatriptan and eletriptan for abortive therapy. The provider is requesting Ubrelvy. The requested medication was denied coverage stating that the patient has not tried and failed three preferred agents for her condition.

Yes, the health plan should cover the proposed treatment.
This patient has tried and failed at least three triptans as required by the Plan. Given that three different triptans have been ineffective, it is unlikely that additional trials of triptans, with the same mechanism of action, will be effective (Thorlund et al.). This includes the formulary alternatives.  Ubrogepant is Food and Drug Administration (FDA) approved for this patient's condition and works via a unique mechanism of action (Dodick et al.). It would be standard of care to utilize Ubrogepant after a trial of three triptans, as is the case here.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dementia

Treatment: Continued long-term custodial care services

The insurer is denied coverage for continued long-term custodial care services.

The denial is overturned. 

This male patient has a history of hypertension, dementia, ulcerative (chronic) pancolitis with other complication, unspecified atrial fibrillation, and ST-Segment Elevation Myocardial Infarction (STEMI).

Data from the American Society of Colon and Rectal Surgery Clinical Practice Guidelines for Ostomy Surgery suggest that even patients with long-term ostomies have significant ostomy-related technical problems and require care. Non-specialized healthcare providers are not comfortable managing ostomy problems. Specialized ostomy nurses provide essential service to patients with ostomies beyond the perioperative period. Late complications (greater than [>] 3 months) of ostomy include parastomal hernia, stomal prolapse, stomal stenosis, wound infection, delayed healing and hernia formation. 

Ileostomy patients are at risk for dehydration and this is the most common cause of hospital readmission after ileostomy surgery. Patients with ileostomy have to increase their daily fluid intake beyond the recommended average intake for the general population by at least 500 to 750 ml (milliliters), and to drink even more during periods of high volume output or heavy sweating. This patient will not have the ability to monitor his fluid intake due to his psychological impairments of delusions and poor insight and judgment. 

The patient also has other medical conditions that require compliance with medication intake to avoid serious long-term consequences. His medications include hydrocortisone to avoid exacerbation of ulcerative colitis. He is on anticoagulation due to atrial fibrillation and coronary artery disease. Failure to take this medication will lead to increased risk for cerebrovascular accident. Due to the patient's complex medical condition, he will require skilled nursing level of care.

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

The carrier's denial of coverage for the continued long-term custodial care services is overturned. The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: colitis.
Treatment: inpatient hospital admission.
The insurer is denied coverage for inpatient hospital admission.
The denial is overturned. 

This female patient has a history of marijuana abuse.

This patient presented to the ER(emergency room) with abdominal pain and examination showed tenderness. She had leukocytosis on presentation and the CT(Computed tomography)showed colitis of the transverse colon. At this point the potential diagnosis is wide, including infectious colitis, clostridium (C) difficile, inflammatory bowel disease, etc. The outcome is difficult to predict at the early stage and an inpatient admission to evaluate and treat is appropriate.

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

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

Diagnosis: Crossbite
Treatment: Braces, Pre-service
The insurer denied the Braces, Pre-service
The denial is upheld.

The patient is a female.  The request is for dental benefits for orthodontic treatment (braces), pre-service.  

Orthodontic records have been made - x-rays, photos, etc.  The health plan denied the claim stating the requested procedure was not medically necessary.  The provider appealed stating the patient has an anterior crossbite - #6/27.

No, the proposed treatment of orthodontic therapy is not medically necessary.
The records submitted do not support evidence of a crossbite with gingival attachment loss as indicated in the Handicapping Labio-Lingual Deviation (HLD) index.

A cross bite is when an upper tooth lies inside the corresponding lower tooth when the mouth is closed.  This is not evident on the photos submitted. The normal position is for the upper tooth to be just slightly in front of the lower tooth when the mouth is closed.

Orthodontic treatment is an invasive and complex treatment designed to shift teeth within the bone.  If the teeth do not exhibit malocclusion, then orthodontic treatment is not warranted.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Binge Eating Disorder

Treatment Vyvanse 40 milligram (mg) OR (oral) CAPS (capsule)

The insurer denied coverage for Vyvanse 40 milligram (mg) OR CAPS

The denial is overturned

The patient is a female that has binge eating symptoms including episodes 1-2 times per week of binging, then feeling remorseful, and then reporting worsened mood and feeling out of control regarding her binge eating. She had a diagnosis of binge eating disorder, premenstrual dysphoric disorder and bipolar disorder. She reportedly was taking Vyvanse 40 mg per day to target binge eating as well as Latuda and Propranolol.

The insurer denied coverage for Vyvanse 40 mg per day. They stated that she should consider a preferred drug on the formulary list such as Sertraline, Fluoxetine, Escitalopram, Citalopram, or Topiramate.

Vyvanse is a Food and Drug Administration (FDA)-approved medication for binge eating disorder and this patient has a diagnosis of binge eating disorder. The American Psychiatric Association News stated that Vyvanse was FDA-approved for the treatment of binge eating disorder. Also, according to a physician "Efficacy and Safety of Lisdexamfetamine for Treatment of Adults with Moderate to Severe Binge Eating Disorders," because of the limited options available to treat binge eating, the FDA approved lisdexamfetamine (Vyvanse) for the treatment of binge eating disorder. It was reported that there were two 12-week studies and lisdexamfetamine was effective in reducing binge days and in decreasing obsessive compulsive thoughts and behaviors about binge eating. It is the first and only FDA-approved treatment for binge eating disorder. Vyvanse also has a unique mechanism of action as it is an inactive prodrug in which d [dextro]-amphetamine is pharmacologically activated after oral ingestion. As a result, she was considered a candidate for this treatment. 

Although, the insurer stated that the patient did not try selective serotonin reuptake inhibitors (SSRI's) such as Citalopram, Escitalopram, Fluoxetine, or Sertraline, these are not FDA-approved for binge eating disorder. They are FDA-approved for major depressive disorder and anxiety disorders, but this patient used Vyvanse for binge eating disorder. Even though Topiramate, which is an anti-seizure medication that can have decreased appetite as a possible side effect, it is not FDA-approved for binge eating disorder and has a different mechanism of action. 

Only Vyvanse has been FDA-approved for binge eating disorder. There was sufficient evidence to support that Vyvanse was considered medically necessary treatment for this patient.

The health care plan did not act reasonably, with sound clinical judgment, or in the best interest of the patient.

The insurer's denial of coverage for Vyvanse 40 mg OR CAPS is overturned. Medical necessity is substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gynecological-uterine myoma. 
Treatment: Surgical Services-Radiofrequency ablation with imaging guidance. 

The health plan denied the treatment as experimental/investigational. The reviewer has upheld the health plans determination. 

The patient has uterine myomas who was recommended treatment with radiofrequency ablation imaging guidance. The health plan's determination is upheld in whole. 
There are no data to show that myomectomy with radiofrequency ablation and image guidance is more likely to be beneficial than standard of care myomectomy, or treatments for the patient's fibroids. There are no data that use of this technology is superior or safer than standard of care myomectomy or other treatment options for fibroids. This treatment is not supported by peer reviewed literature, it is not standard of care, and it is not supported by professional organizations.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Digestive System
Treatment: Pharmacy/prescription drug
The insurer denied Esomeprazole Capsules DR. The health plan's determination is upheld.

The patient is a female with gastroesophageal reflux disease (GERD). She presented with good control of reflux on pantoprazole 20 milligrams (mg) daily. 

Esophagogastroduodenoscopy for the indication of dyspepsia (despite proton pump inhibitor) showed no evidence of reflux, and showed gastric polyps and antral gastritis; biopsies showed mild reflux-associated changes in the esophagus, mild chronic gastric inflammation, and proton pump inhibitor-associated gastric changes.

A second Esophagogastroduodenoscopy for the indication of dyspepsia showed no evidence of uncontrolled reflux disease, and gastric polyps; biopsies showed reflux-associated changes in the esophagus, minimal chronic nonspecific gastritis, and fundic gland polyps.

Under review is the use of Esomeprazole Capsules.

The request for esomeprazole is not supported over the formulary proton pump inhibitors (lansoprazole, omeprazole, Dexilant), as these would not be expected to have lower efficacy or different adverse effects from esomeprazole.

Proton pump inhibitor therapy is recommended by American College of Gastroenterology guidelines for gastroesophageal reflux disease. The patient is documented to have failed pantoprazole. Comparison of multiple proton pump inhibitors (PPIs), including omeprazole, esomeprazole, pantoprazole, lansoprazole, and rabeprazole has found no difference in control and healing of GERD between them, and superiority of Dexilant to esomeprazole. In this case, there is no documented reason to use esomeprazole over the formulary alternatives that have not been attempted. A formulary exception is not indicated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Mixed hyperlipidemia
Treatment: Vascepa (icosapent ethyl)
The insurer denied the Vascepa (icosapent ethyl).
The denial is upheld.

The patient is a male. He has history of CAD (coronary artery disease) and diabetes. It was stated that he is on maximum dose statin, and his TG (triglyceride) is greater than 600. He had documented TG (triglyceride) of 659. LDL (low-density lipoprotein) could not be determined due to high levels of TG (triglycerides). There is no documentation of failure or intolerance to Zetia. The request is to continue Vascepa.

No, unless patient tries and fails Zetia, the treatment with Vascepa is not medically necessary.

Community practice suggests that high-dose statin (which the patient is on), and Zetia (which he is not prescribed) be tried and failed prior to use of Vascepa. There is no documentation that the patient has tried and failed Zetia. There is not documentation that the patient has any contraindications to Zetia.

Therefore, given the above, the treatment with Vascepa is not medically necessary for this patient at this time.

The decision is consistent with guidelines and best practice.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Bipolar 1 Disorder or Schizophrenia

Treatment: Vraylar (cariprazine)

The insurer denied coverage for Vraylar (cariprazine)

The denial is upheld.

This is a patient with a diagnosis of Bipolar Disorder I-Current Episode Depressed-Mild or Moderate. She reportedly had worsened depression and anxiety and wanted to try another medication to target her mood symptoms. She was taking Vryalar (Cariprazine) which is a Food and Drug Administration (FDA) approved medication for the treatment of bipolar 1 disorder or schizophrenia and was taking it 3 weeks with some reported improvement in symptoms. She also was taking Cymbalta 30 mg (milligram) BID [twice daily] as well. She reportedly had past trials of Quetiapine which is a mood stabilizer also, Wellbutrin, Prozac, Paxil, which are antidepressants, and Xanax which is an anti-anxiety medication and reported lack of efficacy or worsened symptoms with them. 

This reviewer agrees with the decision to deny coverage for Vraylar (Cariprazine) for the treatment of bipolar disorder as there was no specific evidence to support that there were contraindications to taking formulary mood stabilizer medications including Aripiprazole, Risperidone, Olanzapine, Ziprasidone or that she tried and failed these formulary FDA approved medications for the treatment of bipolar 1 disorder. 

The American Psychiatric Association (APA) Practice Guidelines for the Treatment of Patients with Bipolar Disorder reports that standard pharmacotherapy includes Lithium, anticonvulsants such as Depakote and Carbamazepine, and antipsychotic medications and the above-mentioned FDA approved formulary medications were considered standard treatment for bipolar disorder. She did not try and fail formulary medication Aripiprazole which is a dopamine partial agonist and also an antagonist with a unique mechanism of action. The patient did not reportedly try and fail Olanzapine, Risperidone, Paliperidone, or Ziprasidone. 

Each medication has a unique receptor mechanism of action although they are dopamine and serotonin antagonists so there was no specific evidence to support that these medications could not treat her symptoms and diagnosis. Vraylar (cariprazine) is a dopamine partial agonist and partial serotonin 5HT1A (receptor) agonist and antagonist of serotonin 5Ht2A (receptor) and typical starting dosages are 1.5 mg with a maximum dosage of 6 mg per day and is FDA approved for bipolar 1 disorder, but she did not try the other formulary medications. Also, she was taking this only 3 weeks and given samples so she reportedly was not taking this for a long period of time. There were no reported contraindications for use of these formulary FDA approved medications for bipolar disorder. 

Vraylar was not considered medically necessary. There are other FDA approved formulary medications that were not tried such as Olanzapine, Risperidone, or Ziprasidone.  It appeared that the health care plan acted reasonably and with sound medical judgment. 

The insurer's denial of coverage for Vraylar (cariprazine) is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Intractable Vomiting. 

Treatment: Full hospital admission. 

The insurer denied coverage for full hospital admission. 

The denial is overturned. 

The patient has a past medical history of traumatic brain injury (TBI), pelvic fractures, right patellar fracture after being hit by a car, hyperlipidemia, hypertension, urinary tract infections (UTI) and dysphagia with a tracheostomy and percutaneous endoscopic gastrostomy (PEG) tube.  The patient presented to the emergency department with complaints of constipation and vomiting.  Per the husband, the patient had not been able to tolerate anything via the PEG tube.  Everything came back up.  The patient had some confusion, which was baseline per the husband.  The patient had required multiple hospitalizations for urinary tract infections and other issues related to her declining health.  The Computed tomography scan of the head revealed no acute intracranial process.  The CT of the abdomen revealed significant fecal distention of colon from cecum to proximal descending colon.  The gastrostomy tube was in place.  The hemoglobin was 9.4.  The electrocardiogram (ECG) was normal sinus rhythm.  The chest x-ray revealed minimal linear atelectasis/scarring.  The patient problems included intractable vomiting/fecal impaction.  The CT of the abdomen cannot exclude age-indeterminate hematoma of the right gluteus maximus muscle overlying the right greater trochanter.  The husband requested a dysphagia evaluation.  The urinalysis was positive for bacteria.  The patient was to undergo palliative care.  The patient was admitted for intractable vomiting.  The patient underwent consultations and was treated with medications.  The patient was stabilized and discharged. 

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

The full hospital is considered medically necessary for this patient. 

The patient had multiple gastrointestinal issues in addition to multiple comorbidities that needed addressing. She was malnourished and was not able to keep food in the gastrointestinal (GI) tract. PEG feeds were being brought out orally. This is a risk for aspiration and may indicate a bowel obstruction. It is imperative that the feeding issues are addressed. 

The insurer's denial of coverage for the full hospital admission is reversed. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Gastroparesis.
Treatment full hospital admission.
The insurer denied coverage for full hospital admission.
The denial is upheld.

The patient had a history of cyclic vomiting related to cannabinoid hyperemesis. She presented with epigastric pain and vomiting. An endoscopy showed a small hiatal hernia and a gastric emptying scan showed gastroparesis. The patient was hemodynamically stable. There was no abdominal rebound or guarding and her renal function was normal. Intravenous hydration was given and by the time of admission the patient reported feeling better. 

Milliman Care Guidelines (MCG) clinical indications for admission for Vomiting include gastrointestinal obstruction, a severe metabolic derangement, hemodynamic instability, severe electrolyte abnormalities, acute renal failure and an inability to maintain oral hydration after observation care. The patient did not have these conditions.

This patient had vomiting and epigastric pain which improved after treatment in the emergency room. Intravenous hydration, proton pump inhibitor (PPI) therapy and antiemetics could have been given in the emergency room as an outpatient. Based on the review, a full hospital admission was not medically necessary. She could have been managed with observation care. 

The health care plan acted reasonably, with sound medical judgement and in the best interest of the patient. 

The insurer's denial of coverage for the full hospital admission is upheld. Medical necessity is not substantiated.