Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD (gastroesophageal reflux disease).
Treatment: Surgery (laparoscopic anti-reflux surgery utilizing LINX system(43284).
The insurer denied the Surgery (laparoscopic anti-reflux surgery utilizing LINX system(43284).
The denial is overturned.

The patient is a female with chronic GERD (gastroesophageal reflux disease) that is causing severe reflux. It is causing moderate dysphagia that at times per her letter, makes her choke on food. She is otherwise healthy. She is currently on maximal medical therapy. Manometry showed a large number of ineffective swallows. Upper GI (gastrointestinal series) showed severe reflux. Her Demeester score was 17.2. Her EGD (esophagogastroduodenoscopy) did not show any masses or Barrett's. Patient was denied authorization from insurance plan due to the LINX procedure being classified as experimental and off label.

Yes, the health plan should cover the LINX procedure.
Magnetic sphincter augmentation has been shown in recent studies to be equally effective for treating moderate to severe GERD (gastroesophageal reflux disease). The patient meets all criteria for surgical intervention regarding her GERD (gastroesophageal reflux disease), as she is now choking on food. This puts her at risk for aspiration and sudden death, not to mention all clinical and diagnostic criteria for surgical intervention of GERD (gastroesophageal reflux disease). LINX has been shown in multiple papers to have good clinical response of patients with GERD (gastroesophageal reflux disease), but also increasing their quality of life. This should be deemed medically appropriate.

Yes, the LINX procedure is more beneficial.
With the literature provided in the document, LINX has been shown not be associated with excessive nausea and gas bloat syndrome (Patients cannot belch) rather than patients who undergo standard laparoscopic Nissen Fundoplication. This provides a better functional outcome and increases quality of life for the patient.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Stelara 90mg every 6 weeks. 
The denial is overturned.

The patient is a female with Crohn's disease. She failed mesalamine and budesonide. She started Stelara in with improvement in symptoms. A colonoscopy showed some improvement but persistent mild inflammation in the distal transverse colon to descending colon, with biopsies showing mild active chronic colitis. She had recurrent symptoms including bloody diarrhea and left lower quadrant abdominal pain, as well as fecal calprotectin greater than (>) 3000 micrograms (mcg) /grams (g); she has required corticosteroids. Stelara level was low at 3.5. Her provider is recommending Stelara 90milligrams (mg) every 6 weeks for the treatment of Crohn's disease.
At issue is whether Stelara 90mg every 6 weeks is likely to be more beneficial than any standard treatment.

The health plan's determination regarding the proposed health service or treatment is overturned in whole.

The proposed health service or treatment Stelara 90mg every 6 weeks is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Stelara 90mg every 6 weeks is likely to be more beneficial than any standard treatment for the treatment of the patient's Crohn's disease. Stelara is United States 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] One study showed that dose escalation was required in approximately half of patients, and successful in 61.1% of dose escalation attempts. [5]
Additionally, American College of Gastroenterology (ACG) 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 had initial improvement, followed by symptoms and objective evidence of active disease on Stelara every 8 weeks; additionally, her Stelara level was low. Continuation of 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 patient with moderate to severe disease. For all of these reasons, the use of Stelara 90mg every 6 weeks is supported as medically necessary for the treatment of Crohn's disease in this case.
Therefore, the proposed health service or treatment Stelara 90mg every 6 weeks is likely to be more beneficial than any standard treatment or treatments.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Gliobastoma multiforme
Treatment: Xpovio
The insurer denied Xpovio.
The determination is upheld.

This is a patient with glioblastoma multiforme. The patient has previously failed treatment with radiotherapy plus (+) temozolamide and with bevacizumab. Selinexor (Xpovio) has been recommended and is under review.

The Xpovio is not medically necessary. This is a patient with glioblastoma multiforme. The approach proposed for treatment of this patient remains the subject of ongoing investigation in at least two clinical trials - National Clinical Trial (NCT) 04421378 and National Clinical Trial (NCT) 02323880. Neither the National Comprehensive Cancer Network (NCCN) nor the authors of UpToDate nor the peer-reviewed literature recommend the use of this agent in this clinical scenario due to the paucity of data indicating an improvement in outcomes. For this reason, medical necessity cannot be established.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Coronary artery disease, neuropathy and incontinence

Treatment Personal Care Services (PCS) at a frequency of 24 hours per day, 7 days per week (split-shift)

The insurer denied coverage for Personal Care Services (PCS) at a frequency of 24 hours per day, 7 days per week (split-shift)

The denial is overturned 

This is a patient with chronic medical problems including coronary artery disease, neuropathy and incontinence.  She lives with her son, who reportedly can no longer care for her at night due to work responsibilities.  She receives PCS at a frequency of 12 hours/day, 7 days/week.  She is requesting Personal Care Services (PCS) at a frequency of 24 hours/day, 7 days/week (split-shift).

According to the Uniform Assessment System (UAS) report, the patient requires maximal assistance to total dependence for meal preparation, housework and shopping.  She requires extensive to maximal assistance for personal hygiene, bathing, dressing, toilet use, transfers and walking.  She is also bladder incontinent.  She is wheelchair dependent for mobility.  The clinical records and assessments support the patient having functional deficits supporting the medical necessity of the requested Personal Care Services (PCS) at a frequency of 24 hours/day, 7 days/week (split-shift); allowing her to continue living safely at home.    

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

From a physical medicine and rehabilitation perspective, the requested Personal Care Services (PCS) at a frequency of 24 hours per day, 7 days per week (split-shift) is medically necessary.  

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 Personal Care Services (PCS) at a frequency of 24 hours per day, 7 days per week (split-shift) is reversed. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Class I Occlusion
Treatment: Braces

The insurer denied braces. 
The health plan's determination is upheld. 

The patient in question is a male with a Class I occlusion with 5 millimeter (mm) overbite and 3mm overjet. He has moderate maxillary and mandibular crowing. He is treatment planned for orthodontics (braces) to correct his malocclusion. 

There is no medical reason to correct this patient's malocclusion with braces. While the patient has crowding, there is no anterior or posterior crossbite. There is no evidence of wear or periodontal recession. There are functional problems that may occur in the dentition that become more difficult, if not impossible, to correct if not addressed in adolescence. This patient presents with none of those conditions. Aligning his teeth will likely not increase chewing efficiency since masticatory efficiency is already highest in patients with a Class I occlusion. The patient's overjet is slightly more than ideal but his overjet would not affect oral health related quality of life unless it was greater than 6 mm. If his teeth were aligned it would provide an esthetic improvement but it would not create a medically significant improvement to the patient's health. Braces are not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's disease
Treatment: Remicade
The insurer denied Remicade 15 mg/kg every 4 weeks. The health plan's determination is overturned.

The patient is a male with Crohn's disease diagnosed at childhood. He has failed methotrexate, Entyvio, and Stelara in the past. He has been on Remicade 1000 milligrams (mg) every 6 weeks for years, with trough levels over 30. He had disease flares with significant postprandial diarrhea up to 10 times per day, intermittent bleeding, and abdominal pain. He had improvement with Remicade. Testing showed Remicade level of 8.0 and lack of anti-Remicade antibodies.

Remicade (infliximab) 15 mg/kg (kilograms) every 4 weeks is medically necessary. Dose intensification is commonly required during therapy with infliximab and can be performed with dose increase and/or frequency increase. In this case, the patient has moderate to severe Crohn's disease, with diagnosis before age 30, and has attempted multiple alternative therapeutic classes for the treatment of Ulcerative Colitis. Given ongoing disease signs and symptoms after initial improvement on Remicade, the request for Remicade 15 mg/kg every 4 weeks is supported to avoid risk for Crohn's disease complications such as fistula, stricture, hospitalization, and need for surgery.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Acute kidney injury on chronic kidney disease
Treatment: Inpatient admission

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

This is the case of a female patient admitted for dehydration and found to have abnormal kidney function secondary to acute kidney injury on chronic kidney disease. Computed tomography of the head was negative for acute intracranial process. She was also found to have hypoglycemia and was treated with intravenous (IV) dextrose. Creatinine improved from 2.1 on admission to 1.7 the following day and hypoglycemia resolved. She was discharged in stable condition the next day.

A randomized study of 13,347 non-critically ill adults requiring IV fluid treatment in the emergency department randomized to treatment with isotonic crystalloid or normal saline found no difference in hospital-free days but found that patients treated with the isotonic crystalloids had a lower composite outcome of death, need for renal-replacement therapy, or persistent renal dysfunction than the saline-treated group.

There is no evidence-based literature showing that inpatient level of care was medically necessary and her condition could be treated safely under lower level of care.

During this admission, the member was hemodynamically stable, with normal oxygenation and negative cultures, did not have significant electrolyte disturbance or irreversible kidney failure. She did not have cardiac arrhythmias, no altered mental status or persistent nausea and vomiting. No documentation of refractory pain and she was able to tolerate oral diet and did not need total parenteral nutrition and her condition responded to IV fluids.

A lower level of care is appropriate when oral replacement therapy is feasible for individuals with mild or moderate dehydration who can drink and have no significant dehydration-related cognitive or physical compromise.

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

The insurer's denial of coverage for the inpatient admission is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Congestive Heart Failure

Treatment: Inpatient hospital admission

The insurer denied coverage for the inpatient hospital admission

The denial is overturned

The patient presented to the hospital complaining of shortness of breath and lightheadedness for two days.  Past medical history was significant for hypertension, diabetes mellitus, coronavirus disease (COVID-19) pneumonia, anemia and chronic kidney disease.  Upon arrival to the hospital vital signs were stable; blood pressure (BP) 169/86, pulse 94.  Physical examination revealed diminished breath sounds at the lung bases and pedal edema.  A 12-lead electrocardiogram revealed normal sinus rhythm without wave abnormalities. Serum blood testing demonstrated anemia, an elevated B type natriuretic peptide and a normal troponin level.  Computer tomography (CT) chest scan revealed no evidence of pulmonary embolism.  Lung fields demonstrated small bilateral pulmonary effusions and prominent pulmonary vessels consistent with congestive heart failure. The patient was admitted to the hospital and treated with intravenous diuretic therapy. Serum creatinine increased from 1.8 to 2.4 milligrams per deciliter (mg/dl).  The patient signed out against medical advice prior to echocardiographic evaluation and additional treatment.

The health plan did not act in the best interest of this patient.  This patient presented with dyspnea, severe anemia, renal insufficiency and small bilateral pleural effusions.  Upon presentation physical exam and laboratory testing confirmed fluid overload.  She required treatment with intravenous diuretic therapy.  She ultimately signed out against medical advice before medical therapy could be transitioned to an oral regimen.  Failure to admit and treat this patient would have resulted in excess morbidity or even mortality.  Patients with chronic congestive heart failure (CHF) and renal insufficiency have a high risk of adverse outcomes warranting a higher level of care (Reference 1). 

Moreover, there is a significant increase in mortality when patients with chronic congestive heart failure present with CHF along with elevated serum Troponin and ECG (electrocardiogram) abnormalities (Reference 2). 

In conclusion, management at a high level of care was warranted.  Inpatient hospital admission was medically necessary.

Based on the above, the medical necessity for the inpatient hospital admission is substantiated. The insurer's denial is overturned.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Skin Conditions. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Humira 80mg-40mg(milligram) pen injection kit. 
The denial is overturned. 

The patient is a female with a diagnosis of granuloma annulare (GA). She has tried and failed clindamycin lotion, hydrocortisone lotion, dapsone, and minocycline. She has also failed topical steroids (Lidex cream) and intralesional Kenalog. The subject under review is whether Humira 80mg-40mg pen injection kit is likely to be more beneficial than any standard treatment for this patient.

The proposed health treatment Humira 80mg-40mg pen injection kit is likely to be more beneficial than any standard treatment or treatments for the patient's disease.
The patient has already tried and failed the conventional therapies for granuloma annulare including but not limited to clindamycin lotion, hydrocortisone lotion, dapsone, and minocycline.
There are several observational studies and case reports of Humira leading to improvement for GA. Rosmarin et al. writes " Anti-tumor necrosis factor (TNF)-alpha therapy may be a therapeutic option in patients with disseminated granuloma annulare poorly controlled with conventional medications." (1) Torres et al. writes "Adalimumab may be an additional option in the treatment of recalcitrant forms of granuloma annulare." (2) Min et al. writes in "Treatment of recalcitrant granuloma annulare (GA) with adalimumab: a single-center, observational study" that "Our results suggest that adalimumab could be an effective and well-tolerated treatment for GA. It is a particularly attractive therapy for patients who have generalized or disseminated GA."(3)
Given that the patient has failed all the standard treatments, Humira is warranted in this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Skin Conditions. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Humira 80mg-40mg(milligram) pen injection kit. 
The denial is upheld. 

The patient is a female with granuloma annulare (GA). The patient has had intralesional steroid injections. The patient has failed dapsone. The patient has an allergic reaction to minocycline in the past. The patient has a medical contraindication to hydroxychloroquine. The subject under review is whether Humira is likely to be more beneficial for this patient than other standard treatments.

Humira is not likely to be more beneficial than any standard available treatment for the patient's condition. Tumor necrosis factor-alpha (TNF-a) inhibitors, such as etanercept, infliximab, and adalimumab, act as anti-inflammatory agents. This group of drugs has been approved for the treatment of rheumatoid arthritis, psoriatic arthritis, moderate to severe plaque psoriasis, ankylosing spondylitis, Crohn disease, and juvenile idiopathic arthritis. As reported by Lebwohl et al. "7 patients with physician-verified GA who were treated with adalimumab. Primary endpoints were improvements in GA Investigator Global Assessment score and body surface area. Secondary end points included erythema and induration improvement. All patients GA Investigator Global Assessment scores improved by 2 or greater. We found significant improvements in body surface area, erythema, and induration (average improvements by 87%, 88%, and 95%, respectively)."
There is insufficient evidence by way of large randomized controlled cohort trials showing the long-term safety and efficacy of TNF drugs such as Humira in treating patients with granuloma annulare. There is a lack of consensus with regards to optimal dosing, frequency of injection and duration of therapy. There are case reports in the medical literature of the paradoxical effect of TNF drugs inducing granuloma annulare. A medical exception for the use of Humira in this patient has not been established.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Skin Conditions. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Humira 80mg-40mg(milligram)pen injection kit. 
The denial is upheld. 

The patient is a female with generalized granuloma annulare, which causes severe psychological distress. The patient has tried and failed oral Dapsone. Hydroxychloroquine is contraindicated because she is taking escitalopram, and the potential of QT prolongation while taking these two medications together is of concern. The patient is allergic to minocycline. Class 1 super high-potency topical steroids and intralesional triamcinolone injections have also been tried and failed.
Humira is under review to determine if it is likely to be more beneficial for this patient's condition.

The treatment with Humira is not likely to be more beneficial than any standard treatment for the patient's granuloma annulare.
Current medical literature [1-4] establishes that there is, unfortunately, no gold standard to the treatment of generalized granuloma annulare. Fortunately, there are very few functional or physical impairments due to this condition, but social/psychological impacts can be profound. Treatments such as with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs) are all appropriate for this patient, and these have not yet been exhausted. Light therapy is another option. Humira is a third- or fourth-line treatment for generalized granuloma annulare, and because other, more commonly utilized treatments have not been tried to date, and because the condition is neither life-threatening nor disabling, the requested Humira is not likely to be more beneficial in treating this patient's skin condition.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Right Leg Pain and Swelling
Treatment: Inpatient admission
The insurer denied the inpatient admission
The denial is upheld. 

The patient in this case is a male. He has a history of recurrent DVT (deep venous thrombosis) and was on treatment with anticoagulation.  He presented to the emergency department with a two day history of pain in the right leg along with pleuritic chest pain for one day.  He had been off anticoagulation for several days because he was out of state and unable to get a new supply of Eliquis.

The patient's CT (computed tomography) chest revealed no pulmonary embolism and ultrasound revealed an acute partially occlusive left leg deep vein thrombosis.  No acute DVT (deep venous thrombosis) was seen in the right leg.  He was admitted to the hospital and treated with IV (intravenous) heparin infusion.  On the following day, he had no pain or swelling in either leg.  Thrombophilia labs were recommended by hematology, and also recommended was resumption of Eliquis.  The labs could not be obtained despite two attempts.  He was discharged the next day.

No, the Inpatient admission was not medically necessary.
This patient had an acute partially occlusive DVT (deep venous thrombosis) in the left leg not associated with symptoms. He had come to the ED (emergency department) with right leg symptoms, which notably had resolved by the time he was admitted.  He had been off Eliquis.  He was hemodynamically stable, and there was no evidence of circulatory compromise in the left leg.  Pulmonary embolism had been ruled out.  He did not require acute care inpatient hospitalization.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: mobility issues.
Treatment: Home health care.
The insurer denied. 
The health plan's determination is upheld. 

The patient is a male child with complex medical history significant for FATCO (fibular aplasia, tibial campomelia, and oligosyndactyly), status post bilateral lower extremity amputations, ASD (atrial septal defect) and ventricular septal defect (VSD) with secondary heart failure status post repair. He has claw hand deformity and is unable to grasp some objects. He also has anxiety since his most recent surgery. He eats well by mouth. He is wheelchair-bound and needs assistance with all activities of daily living. He is no longer incontinent but has occasional accidents.

The requested Consumer Directed Personal Assistance Service (CDPAS) Hours: 42 Hours per Week is medically necessary for this patient.

This child has suffered significant disability as a result of and in addition to his chronic medical condition. While he remains dependent upon caregivers more than would be expected for a typical child his age, he has made significant improvements since his heart surgery. He no longer requires personal assistance 6 hours/day, 7 days/week as was previously necessary. He only requires personal assistance while his mother is at work 4 hours/day, 5 days/week. This is most consistent with his current medical and developmental condition, the literature, and the current standard of care. The hours approved by the health plan as sufficient to meet the patient's needs.