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

Diagnosis: Esosinophilic esophagitis
Treatment: Dupxient
The insurer denied Dupxient.
The determination is overturned.

This is a male patient with a history of eosinophilic esophagitis (EoE). He tried and failed swallowed corticosteroids. The requested service is Dupixent. At issue is whether the Dupixent is medically necessary.

Eosinophilic esophagitis (EoE) is a chronic inflammatory condition that affects the esophagus and causes feeding difficulties, dysphagia, vomiting and growth delay. If untreated, it can progress to esophageal strictures. Treating this condition is very challenging in pediatric patients.
Dupixent is Food and Drug Administration (FDA) approved for treating EoE for ages 12 and older. Currently, there are no FDA approved treatments for EoE in children younger than 12. The available therapies include elimination of allergens via strict diet or exclusive elemental formula, or long term swallowed corticosteroids (such as budesonide). However, many patients have refractory disease and do not respond adequately to the available conventional therapies.
The use of Dupixent for treating refractory eosinophilic esophagitis is appropriate and supported by adequate peer reviewed literature.
According to Dellon, Evan, et al: "Weekly dupilumab improved disease-specific health related quality of life (HRQoL) and reduced symptom burden in adolescent/adult EoE patients."
According to Hirano, Ikuo, et al: "In a phase 2 trial of patients with active EoE, dupilumab reduced dysphagia, histologic features of disease (including eosinophilic infiltration and a marker of type 2 inflammation), and abnormal endoscopic features compared with placebo. Dupilumab increased esophageal distensibility and was generally well tolerated."
Finally, Sanofi announced in a press release recently that a Dupixent (dupilumab) Phase 3 trial showed positive results in children 1 to 11 years of age with eosinophilic esophagitis.
The patient has already tried and failed the available alternatives. Therefore, the intended off-label use of Dupixent is medically appropriate and necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic dermatitis

Treatment: Dupixent 300 milligrams per 2 milliliters (300MG/2ML) subcutaneous pen injector

The insurer denied coverage for Dupixent 300 milligrams per 2 milliliters (300MG/2ML) subcutaneous pen injector.  The denial is overturned.

The patient is an adult with a diagnosis of severe atopic dermatitis (AD). The patient has failed topical steroid therapy as well as oral prednisone and cyclosporin. The patient has > (greater than) 75% (percent) Total Body Surface Area (TBSA) involvement. The patient has been on Dupixent for 1 year with clinical clearance and no adverse side effects. The requested medication is Dupixent.  

The patient has severe atopic dermatitis that involves a large surface area. The patient requires systemic therapy given the extent of involvement and the use of Dupixent would appear to be reasonable given that it is Food and Drug Administration (FDA) approved for the treatment of atopic dermatitis. The patient has been successfully treated with Dupixent for 1 year and has previously failed systemic therapy with prednisone and cyclosporin. The request for Dupixent is supported by the medical literature and specialty society guidelines. Dupixent is the first systemic therapy approved by the FDA for the management of atopic dermatitis. In early 2017, the FDA approved Dupixent for adults with moderate-to-severe atopic dermatitis who are inadequately controlled with topical treatments. According to consensus guidelines, Dupilumab has shown strong efficacy and safety for treatment of moderate-to-severe Atopic Dermatitis. Considering the safety profiles of conventional systemic therapies, which are not FDA-approved for AD treatment, it is recommended that dupilumab be used as a first-line systemic treatment in patients with moderate-to-severe AD who are uncontrolled with topical therapies". The decision is overturned, and Dupixent is approved at the medical discretion of the physician, based on the standard of care and the provided medical documentation.   

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 Dupixent 300 milligrams per 2 milliliters (300MG/2ML) subcutaneous pen injector is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Asthma
Treatment: Inpatient Hospital Stay
The insurer denied Inpatient Hospital Stay.
The determination is upheld.

This patient has a past medical history (PMH) of asthma, diabetes mellitus type 2 (DM2) and hypertension (HTN) who was admitted to the hospital with complaints of (c/o) shortness of breath (SOB) and coughing. The vital signs were notable for tachycardia. The physical exam was notable for frequent coughing, expiratory wheezes, with peripheral capillary oxygen saturation (SpO2) decreases during coughing. While coughing the patient's peripheral capillary oxygen saturation (SpO2) dropped to 88% and resolved when the patient was no longer coughing.

The laboratory evaluation was notable for positive influenza. A chest x-ray (CXR) showed no acute disease. An electrocardiogram (EKG) showed no acute ischemic changes. The patient was diagnosed with asthma exacerbation and treated with intravenous (IV) steroids, Tamiflu, and pulmonary treatments. The patient was discharged in stable condition. At issue is the medical necessity of the inpatient stay.

The health plan, in its determination of medical necessity, acted reasonably, with sound medical judgment and in the best interest of the patient.

No, the requested health service/treatment of inpatient admission was not medically necessary for this patient. There was no requirement for intubation, no evidence of carbon dioxide (CO2) narcosis with oxygen saturation less than (&lt;) 90%, severe acidosis, concomitant cardiac disease, acute coronary syndrome, new arrhythmia, congestive heart failure exacerbation, pulmonary embolism, pneumonia, lobar collapse, cyanosis, depressed mental status or altered level of consciousness (LOC), impending respiratory failure, or new ischemic electrocardiogram (ECG) changes.

The patient did have intermittent hypoxia, but this resolved with the cessation of coughing. This patient was treated with intravenous (IV) steroids, pulmonary nebulizer treatments, and antibiotics.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Ehlers-Danlos syndrome.
Treatment:  Ultralight Wheelchair.

The insurer denied the Ultralight Wheelchair.  The denial is upheld.

The patient is an adult female with a history of chronic weakness and gait abnormality secondary to Ehlers-Danlos syndrome.  She has difficulty with mobility secondary to weakness. She is currently ambulating with a rollator.  She uses a transport wheelchair for community distances but is dependent for propulsion.  The request is for an ultralight wheelchair.  This was initially denied and is being reviewed upon appeal.

The proposed treatment is not medically necessary.

The patient has a diagnosis of weakness and Ehlers-Danlos syndrome. She is ambulatory short distances with a rollator.  She is dependent for propulsion in a transport chair.  The patient's needs can be met with a less intensive device than the requested custom ultralight wheelchair.  Based on the documentation, the patient is not able to reach independence even with an ultralight wheelchair.  The patient's mobility needs can be met with a rollator or less intensive wheelchair for household mobility.  The requested ultralight wheelchair is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Family history of Factor V Leiden mutation
Treatment: Gene Test
The insurer denied: Gene Test
The denial is upheld

The patient in this case is an adult female. She has a family history of Factor V Leiden mutation. Records note that she has two maternal aunts with a history of thrombotic disease. One had a stroke and the other had lower extremity venous thrombosis. She has no personal history of thrombosis. Factor V Leiden testing was done.

The requested health service is not medically necessary.

There is no evidence showing that testing unaffected patients who have a family history of Factor V Leiden mutation can improve health outcomes. No treatment is given based on the presence or absence of this mutation in an unaffected individual. At the present time, testing unaffected individuals based on family history is not considered standard of care. Given these considerations, the Factor V Leiden mutation test done for the unaffected patient in this case was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Gastroenteritis

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission

The denial is upheld
 

The patient had a history of Crohn's disease, pancreatic insufficiency, and diverticulosis and presented with abdominal pain, vomiting, and diarrhea. A colonoscopy was noted to be unremarkable. In the emergency room (ER) he had a tachycardia which resolved by the time of admission. He was afebrile with a normal blood pressure. There were no peritoneal signs. The white blood cell (WBC) count was 28.6. The abdominal computed tomography (CT) scan showed mild scattered fluid filled loops in the small intestine suspicious for either an ileus or mild enterocolitis. The lactic acid was 2.2. He was treated for colitis with Zosyn. Intravenous (IV) fluids were given for a creatinine of 1.6. The kidney injury and leukocytosis resolved. An endoscopy was performed, and gastritis was found as well as several gastric polyps which were removed. His symptoms improved and he was able to tolerate a diet. 

Medical necessity was determined based on Milliman Care Guidelines (MCG) guideline M-170 for Gastroenteritis. Clinical indications for admission include having a suspected severe infection such as bloody diarrhea, peritoneal signs, hemodynamic instability, acute renal failure with a rise in creatinine of 2 times the baseline and worsening clinical status, severe electrolyte abnormalities, and an inability to maintain oral hydration after observation care. The patient did not have these conditions. 

This patient had gastroenteritis and a rise in the creatinine level to 1.6. Intravenous (IV) hydration and antibiotics were required. However, he could have received this treatment with observation status. He responded well to the treatment and the leukocytosis and kidney injury resolved. He could then have been discharged on an oral antibiotic. He did not meet MCG criteria for admission for Gastroenteritis. 

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

This is a female patient with chronic migraine who is requesting treatment with Botox for prevention of chronic migraine. The request is for continuation of the drug. The patient has previously tried and failed oral preventative medications prior to use of Botox. The drug was denied by the plan because the member has not tried and failed Aimovig, Ajovy, and Emgality. The provider appealed the determination. At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects. 

The available formulary alternatives of Emgality, Ajovy, and Aimovig are all safe and effective for prevention of episodic and chronic migraine. The drugs have been shown to be safe and effective for prevention of migraine and generally result in a 50 percent (%) decrease based on the results from randomized controlled trials in the peer reviewed literature. While Botox is also Food and Drug Administration (FDA) approved for prevention of chronic migraine, there are no head to head studies to show that Botox is more or less effective than injectable calcitonin gene-related peptide (CGRP) inhibitors. As such, there is no evidence that the formulary alternatives would not be effective or would not be as effective as the requested Botox. The injectable CGRP inhibitors generally do not have a significant side effective profile other than some mild constipation.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Lupus
Treatment: Rasuvo
The insurer denied Rasuvo. 
The health plan's determination is Upheld.

This patient has been diagnosed with Systemic Lupus Erythematosus (SLE) and is experiencing a variety of symptoms, including rising anti-double stranded DNA (anti-dsDNA), new-onset Raynaud's with chilblains, oral ulcers, malar rash, polyarthralgia, and recent pleurisy. Despite being on Plaquenil and Benlysta, the patient has been experiencing persistent mucocutaneous and musculoskeletal flaring. The patient did not tolerate MMF (Mycophenolate mofetil) and had weaned off prednisone. While methotrexate (MTX) had helped with arthritis, it was put on hold due to efforts to become pregnant, which are now indefinitely on hold. 

A formulary exception is not indicated in this patient's case. 
The requested agent (Rasuvo) has similar efficacy and safety profile to the plan's formulary agents There is no contraindication to the use of the plan's preferred formulary agents. This patient can use generic methotrexate and can draw this in a syringe. She does not have significant hand deformities precluding the use of methotrexate. Despite tenderness, there were no hand deformities noted, and the patient's range of motion was normal. Therefore, a formulary exception is not indicated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Lumbar Spondylolisthesis
Treatment: Lumbar spinal fusion
The insurer denied a lumbar spinal fusion. 
The health plan's determination is upheld. 

This is a female with a history of low back and right leg pain and a prior right L (lumbar) 4-5 discectomy as shown on magnetic resonance imaging (MRI). She has had physical therapy, injections and medications without relief. She is a non-smoker. The neurologic exam shows no motor, sensory or reflex abnormalities. The lumbar MRI shows no evidence of spondylolisthesis. There is foraminal stenosis at L5-S (sacral)1. X-rays do not describe spondylolisthesis at L5-S1. The provider has recommended an L5-S1 lumbar fusion. 

The Lumbar Spinal Fusion is not medically necessary. The provider describes several imaging findings not supported on reports, including spondylolisthesis and a foraminal disc herniation at L5-S1 right. The imaging reports shows foraminal narrowing at L5-S1. The literature does not support lumbar fusion for a lumbar decompression without spondylolisthesis or instability. Therefore, the requested procedure is not medically necessary at this time.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Alpha 1 antitrypsin deficiency

Treatment: Injection of Alpha 1 Proteinase Inhibitor (code J0256)

The insurer denied coverage for Injection of Alpha 1 Proteinase Inhibitor (code J0256)

The denial is upheld 

The patient is an adult who has history of dyspnea with cold weather exposure. The patient had Alpha 1 antitrypsin levels sent which were 89 and 86 Milligrams per decilitre (mg/dl) and has MZ phenotype. Pulmonary Function Tests showed a forced vital capacity (FVC) of 2.48 liters, forced expiratory volume (FEV1) of 2.05 liters and a ratio of 83 %. Lung volumes were normal with mild reduction in diffusing capacity for carbon monoxide (DLCO) to 70%. No obstruction.

This patient was recommended Alpha 1 proteinase inhibitor infusion; however, this patient does not meet criteria for Alpha 1 antitrypsin replacement as the levels are greater than 57 mg/dl.
There is no documentation that the alpha antitrypsin level is less than 11 Millimoles per litre (mmol/L) which confirms the diagnosis. The patient does not have a high-risk phenotype such as: alpha-1-antitrypsin deficiency (PiZZ), PiSZ, Protease Inhibitor Z (PiZ) null, Pi null or Pi malton Pi Siyama.

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 Injection of Alpha 1 Proteinase Inhibitor (code J0256) is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Spinal cord injury
Treatment: Environmental modifications (EMODs) for the bathroom
The insurer denied EMODs for the bathroom.
The health plan's determination is upheld.

This is a case review for a male being prescribed environmental modifications (EMODs) for the bathroom for the diagnosis of functional limitations, spinal cord injury at T (thoracic) 2-T6 level with sequelae, and neurogenic bowel and bladder. The EMODs requested to the bathroom are a tiled roll-in shower and accessible sink/vanity.

The requested EMODs for the bathroom have not been demonstrated to be medically necessary for this patient.

The patient has clearly documented needs for assistance with activities of daily living (ADLs), as documented by his physician and physical therapist. The submitted documentation does not definitively demonstrate that all of the requested modifications are medically necessary for the patient. There is not a clear itemized list of modifications that would benefit the patient and are not for general utility and exceed the necessity of service. There is no clear documentation that the requested modifications could not be met with other less expensive modifications or durable medical equipment.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.
Treatment: Intracept Procedure.
The insurer denied the Intracept Procedure.
The determination is overturned.

This is a male patient with a past medical history (PMH) of lower back pain (LBP) and microdiscectomy who has ongoing primarily axial and radicular pain which limits is function and activities of daily living (ADLs). He has MRI evidence of lumbar (L) 5- sacral (S) 1 degenerative disc disease (DDD) with modic changes. He has trialed physical therapy, transforaminal epidural steroid injection (TFESI) with some short-term benefit, diclofenac, gabapentin (reported a lack of effect and lightheadedness) and ibuprofen. His pain ranges from a 6-8/10. The patient endorses a significant impact of pain on his function and quality of life. At issue is whether the intraosseous basivertebral nerve ablation procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service is likely to be more beneficial than standard treatments. While this procedure is a relatively more recent treatment, there is a body of research, including randomized controlled trials (RCTs) listed below (3) which has demonstrated significant potential benefit in carefully chosen patients with the Intracept procedure. Additionally, this procedure appears to carry a minimal risk profile. This patient demonstrates chronic lower back pain greater than 6 months with functional deficits, minimal response to prior non-surgical management and evidence of Type 1/2 Modic changes isolated to one level on magnetic resonance imaging (MRI) and therefore is likely a reasonable candidate.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Chronic active Epstein-Barr virus (EBV)
Treatment: Jakafi
The insurer denied Jakafi
The determination is overturned.

This is a female patient with a complex medical history including autoimmune dysregulation with vasculitis, involving the coronary artery, cardiac involvement, pulmonary hypertension (HTN), pulmonary arteriovenous malformations (AVMs), immunoglobulin (Ig) a nephropathy with leukopenia, thrombocytopenia, and chronic active Epstein-Barr virus (EBV) infection.
Th patient was referred for treatment of an EBV infection and the current appeal is for approval of Jakafi (ruxolitinib) for treatment. At issue is whether Jakafi is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Systemic chronic active Epstein-Barr virus disease (sCAEBV) is a rare EBV-positive T- or natural killer (NK)-lymphoproliferative disease. Although the only curative treatment for sCAEBV available now is allogeneic hematopoietic stem cell transplantation (allo-HSCT), the presence of disease activity, persistent inflammation, at the time of allo-HSCT is associated with poor outcomes (1). There have been some studies showing the role of STAT3, which is constitutively activated contributing to cytokine production and cell survival of EBV-infected cells in sCAEBV (2). In some of these cases, where standard treatment such as stem cell transplant which would require intensive conditioning with high-dose chemotherapy, may not have great outcomes, as the patient already has persistent inflammation as is obvious by the various systems involved , nephropathy, thrombocytopenia, leucopenia, myocarditis, uveitis, STAT3 inhibition by ruxolitinib, a Janus kinase (JAK) 1/2 inhibitor, has shown to be effective and beneficial.
Although there is limited data for ruxolitinib in cEBV infection, the condition itself is very rare. Phase II Study of a JAK1/2 Inhibitor Ruxolitinib for Systemic Chronic Active Epstein-Barr Virus Disease showed encouraging results with complete response (CR) rate and overall response (OR) rate after eight weeks or at early termination, the primary and the secondary endpoints of 28.6 percent (%) (2/7) and 42.9% (3/7), respectively. If this patient is not treated in a timely manner, the disease can be fatal and can progress quickly.
In this patient, as stated by the treating physician, the standard therapy may not be very well tolerated and can result in significant morbidity and mortality. In this case, giving a trial of ruxolitinib may benefit the patient and would be recommended over the standard therapy.