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

Diagnosis: Rheumatoid arthritis
Treatment: Orencia SQ (subcutaneous) 125 mg (milligrams)  
The insurer denied coverage for Orencia SQ 125 mg
The denial is overturned
 
According to the medical records, the patient is an adult with a history of rheumatoid arthritis and buccal parotid mass. The patient failed Enbrel and Humira. The provider prescribed Orencia which is the topic of this review.

The formulary drugs are likely to cause the patient an adverse reaction. Rinvoq and Xeljanz have a black box warning for increased malignancy. The patient already has a mass so jakinibs (JAK)-inhibitors are not a good option for the patient.

The formulary drugs have been ineffective based on the patient's clinical history. The patient failed Enbrel and Humira and already has a mass, so jak-inhibitors are not a good option for the patient.

"Conclusions: In this population-based study of rheumatoid arthritis (RA), Disease-modifying antirheumatic drugs (DMARD) naive patients and male patients were more likely to remain on abatacept (Orencia) with a major clinical response." (Cagnotto, G. et al. 2020).

According to Orencia Package Insert, "Indications and usage: Orencia is a selective T cell co stimulation modulator indicated for: Adult Rheumatoid Arthritis (RA) moderately to severely active RA in adults. Orencia may be used as monotherapy or concomitantly with DMARDs other than tumor necrosis factor (TNF) antagonists."

Per Benjamin, O. et al. (2021), "Disease-modifying antirheumatic drugs (DMARDs) are a class of drugs indicated for the treatment of several inflammatory arthritides, including rheumatoid arthritis (RA), as well as for the management of other connective tissue diseases and some cancers. DMARDs are immunosuppressive and immunomodulatory agents and are classified as either conventional DMARDs or biologic DMARDs. Commonly used conventional DMARDs include methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine. Biologic DMARDs were introduced in the early 1990s and are usually prescribed after the failure of conventional DMARD therapy (ongoing disease activity or clinical or radiographic disease progression). Some biologic agents include infliximab, adalimumab, etanercept, rituximab, abatacept, rituximab, tocilizumab, tofacitinib, among others. Biologic DMARDs are highly specific and target a specific pathway of the immune system. Some of these drugs are monoclonal, chimeric humanized fusions antibodies, while others are receptors that have been fused to a part of the human immunoglobulin or small molecules such as Janus kinase (JAK) inhibitors."     

Orencia would be more appropriate because of the mass and the risk for malignancy. 

The formulary drugs are expected to cause adverse effects. 

The formulary drugs were tried, and the patient did have an adverse reaction or contraindication.

The formulary drug is expected to be ineffective.

The non-formulary drug is expected to be more effective that the formulary alternatives.

The carrier's denial of Request for Formulary Exception for Orencia SQ 125 mg is overturned.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriasis
Treatment: Stelara 90 milligrams (mg)
The insurer denied: Stelara 90 milligrams (mg)
The denial is upheld

The patient is an adult male with psoriasis, treated with topical medications and Stelara 90 mg (milligrams) since last summer with good control. The Provider is requesting continuation of 90 mg (milligrams). The patient's weight is not included. The health plan has denied the 90 mg (milligrams) dose due to lack of trial of 45 mg (milligrams) dose. 

The proposed treatment is not "medically necessary. 

The health plan has denied the 90 mg (milligrams) dose due to lack of trial of 45 mg (milligrams) dose. A trial of 45 mg (milligrams) Stelara would be reasonable, or justification of 90 mg (milligrams) with an accurate patient weight.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Ischemic stroke.
Treatment:  Advanced lipoprotein testing.
 
The insurer denied advanced lipoprotein testing. The health plan's determination is overturned. 

The patient is a young female with an Ischemic stroke leading to hemiparesis without any known etiology. The patient was found to have right-sided left weakness during soccer. She was brought to the emergency department (ED) and after having found to have a thrombosis, required tissue plasminogen activator (TPA) and thrombectomy during which they only found inflamed vessels. Currently, the patient is undergoing thrombophilia work up. Lipoprotein A testing is under review.

Advanced Lipoprotein Testing is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Without any inciting event, a stroke of this nature is not normal in a patient of this age and can have life-threatening and devastating consequences. Elevated Lp(a) (lipoprotein A) levels have been linked to an increased risk of ischemic stroke and peripheral venous thrombosis in childhood. This risk is very well established in adults, and there is reasonable literature to support same in pediatrics, although guidelines do not incorporate it yet for children with no previous symptoms which it does in adults. However, this child has already had a stroke.

Elevated Lp(a) is one of the most common genetic dyslipidemias, affecting nearly 1 in 5 individuals in the US (United States). Levels of Lp(a) are determined by an autosomal co-dominant inheritance. Although acute inflammation may cause temporary interference with measurement, levels remain constant throughout the lifespan of the individual. Adult levels of Lp(a) are achieved by 2 years of age.

Considering the above, Advanced Lipoprotein Testing is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Ischemic stroke.
Treatment:  Advanced lipoprotein testing.
 
The insurer denied advanced lipoprotein testing. The health plan's determination is overturned. 

The patient is a young female, who underwent an evaluation for her history of Ischemic Stroke causing Hemiparesis. Thrombophilia workup included Advanced Lipoprotein Testing. This is under review. 

Advanced Lipoprotein Testing (ALT) is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The Etiology of the patient's ischemic stroke has not been established. Based on her clinical phenotype, a broad coagulation workup is indicated and ALT is an important part of it. Finding a possible coagulopathy would be crucial for the patient's management and prognosis to avert stroke in the future.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Ischemic stroke.
Treatment:  Advanced lipoprotein testing.
 
The insurer denied advanced lipoprotein testing. The health plan's determination is overturned. 

The patient is a female, who presented for evaluation of ischemic stroke. She initially presented with an ischemic stroke that caused hemiparesis. As part of her evaluation, the physician ordered lipoprotein a testing. 

The proposed advanced lipoprotein testing was likely to be more beneficial than any standard treatment or treatments for this insured life-threatening condition. The lipoprotein A testing is considered standard of care.

This young child presented with concerns of an ischemic stroke. Lipoprotein A testing was sent as part of her evaluation as an outpatient. In general, while stroke is rare in pediatric patients, there is certain tests that should be performed in the evaluation of these individuals. Imaging is a key in the evaluation, focusing on intracranial and extracranial cerebral arteries, assessment of the heart structure and function, and hypercoagulability testing should also be performed. When recent case control study noted that hemostatic abnormalities were present in approximately 11% (percent) of cases of pediatric patients who suffered stroke.

As per recent guidelines from the American Heart Association and the American Stroke Association, related to the management of childhood acute ischemic stroke, again, thrombophilia must be considered in those with possible rare underlying conditions, and testing should include factor VIII levels, lipoprotein a, methylenetetrahydrofolate reductase (MTHFR) mutation, and homocysteine level. Inherited conditions that are statistically associated with the first incident acute ischemic stroke in pediatric patients include increased levels of proteins such as lipoprotein a, decreased levels of inhibitors of coagulation, or gene mutations. Specifically for lipoprotein A, this has been noted to independently increase the risk of acute ischemic stroke in pediatric patients. Increased lipoprotein a levels have also been associated with vascular disease.
Therefore, lipoprotein A testing was indicated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atrial fibrillation
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission
The denial is upheld
 
This adult patient presented to the hospital complaining of palpitations. He had a past medical history of multiple cardioversions for atrial fibrillation, hypertension, left bundle branch block, obstructive sleep apnea and heart failure with preserved ejection fraction. Upon arrival, the patient was tachycardic with a pulse of 154 and hypertensive with a blood pressure 183/108. No abnormal findings were recorded on physical examination except for an irregular pulse. A 12-lead electrocardiogram demonstrated atrial fibrillation and left bundle branch block. Serum blood testing demonstrated no elevation in serum troponin.  Previously performed echocardiogram demonstrated an ejection fraction of 45-50%(percent). The patient was treated with intravenous diltiazem and admitted to the telemetry ward. He spontaneously converted to sinus rhythm overnight and was discharged on medical therapy the next day. 

This patient presented with symptomatic atrial fibrillation and was effectively treated with atrial - ventricular (AV) nodal blocking agents. Following evaluation and additional testing, the patient reverted to normal sinus rhythm and was released from the hospital. Bellew studied patients presenting to the hospital with rapidly conducted atrial fibrillation and compared outcomes between those admitted to the in-patient service and those that were observed in the emergency department. In this study of almost 600 patients, there was no difference in outcome. American Heart Association (AHA) guidelines note that admission to the hospital for management of atrial fibrillation in patients that achieve rate control do not require hospital admission. This patient reverted to normal sinus rhythm several hours after presentation and had an extensive previous work up for paroxysmal atrial fibrillation. In conclusion, inpatient admission was not medically necessary. 

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

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

This adult patient presented to the hospital complaining of palpitations. He had a past medical history of multiple cardioversions for atrial fibrillation, hypertension, left bundle branch block, obstructive sleep apnea and heart failure with preserved ejection fraction. Upon arrival, the patient was tachycardic with a pulse of 154 and hypertensive with a blood pressure 183/108. No abnormal findings were recorded on physical examination except for an irregular pulse. A 12-lead electrocardiogram demonstrated atrial fibrillation and left bundle branch block. Serum blood testing demonstrated no elevation in serum troponin.  Previously performed echocardiogram demonstrated an ejection fraction of 45-50%. The patient was treated with intravenous diltiazem and admitted to the telemetry ward. He spontaneously converted to sinus rhythm overnight and was discharged on medical therapy the next day. 

This patient presented with symptomatic atrial fibrillation and was effectively treated with atrial - ventricular (AV) nodal blocking agents. Following evaluation and additional testing, the patient reverted to normal sinus rhythm and was released from the hospital. Bellew studied patients presenting to the hospital with rapidly conducted atrial fibrillation and compared outcomes between those admitted to the in-patient service and those that were observed in the emergency department. In this study of almost 600 patients, there was no difference in outcome. American Heart Association (AHA) guidelines note that admission to the hospital for management of atrial fibrillation in patients that achieve rate control do not require hospital admission. This patient reverted to normal sinus rhythm several hours after presentation and had an extensive previous work up for paroxysmal atrial fibrillation. In conclusion, inpatient admission was not medically necessary. 

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: Formulary Exception
Decision: Upheld

Diagnosis: Hypertension
Treatment: Formulary Exception for Edarbi 40 Milligrams (mg) Tablet
The insurer denied the formulary exception for Edarbi 40 mg tablet.
The denial is upheld.

The patient is an adult female for which the request for Edarbi is under review. There was treatment failure or side effects to losartan HCTZ (hydrochlorothiazide), ramapril, Azor, and amlodipine.

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

In this case, the formulary alternatives are multiple ARB (angiotensin II receptor blocker) and ARB combinations for the treatment of HTN (hypertension). However, no single ARB or ARB combination has been definitively proven to be more effective in the treatment of HTN towards overall improved clinical outcomes.

The health plan prefers that the patient try and fail 3 of the following medications: candesartan, candesartan/HCTZ, irbesartan, irbesartan/HCTZ, losartan/HCTZ, telmisartan/HCTZ, valsartan/HCTZ, olmesartan, and olmesartan HCTZ, before Edarbi would be covered. While the patient has tried and failed losartan HCTZ, the other preferred formulary medications are not documented to have been tried and failed or ineffective for the patient, nor would they be expected to be ineffective. They would be reasonably expected to be as effective as the requested non-formulary drug. There were no adverse effects documented for the patient with the formulary alternatives in this case.

Therefore, given the above, the health plan should not cover the formulary exception for Edarbi in this case.
Appeal type: Formulary Exception
Decision: Upheld

Immunologic Disorders/Other/Arthritis/Ankylosing spondylitis of cervical region.
Pharmacy/Prescription Drugs/Rasuvo.
The health plan denied the requested prescription medication, Rasuvo as not medically necessary. 
The health plan's determination is upheld.

The patient is a woman with a history of HLA B27 ankylosing spondylitis (AS). Per a note from the patient's provider, the patient has mostly peripheral involvement of joint pain and also may have irritable bowel syndrome (IBS), thus oral medications should be avoided; however, IBS is not a contraindication to oral medications used to treat AS with peripheral involvement. Per chart review, the patient has tried and failed Humira, had gastrointestinal side effects with Cosentyx and had difficulty with Methotrexate (MTX) injections (subcutaneous (SQ) syringes) attributed to pain in her hands. The issue in this case is Rasuvo (a MTX autoinjector) is being denied by the health plan. The health plan only covers Rasuvo if the patient has one of the following diagnoses: rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA) or psoriasis.

I uphold, in whole, the health plan's determination.

No, the formulary medication will not be ineffective or not be as effective as the on-formulary drug and adverse effects are equal.
There are numerous other drugs beyond Rasuvo used for the treatment of AS. As per UpToDate, 'in patients with symptoms and findings predominantly of peripheral arthritis, we use a conventional disease-modifying antirheumatic drugs (csDMARD) first before switching to a tumor necrosis factor (TNF) inhibitor. Use of sulfasalazine (SSZ) prior to TNF inhibitors is limited to patients with prominent peripheral arthritis.' Moreover, anti-TNF agents as well as interleukin (IL-17) blockers are effective in AS as are Janus Kinase (JAK) inhibitors. As published in Ann Rheum Dis 2015 'compared with placebo, TNF blockers improve disease activity and functional capacity clinically meaningful for both AS and non-radiographic axial spondyloarthritis (nr-axSpA) patients. Moreover, ixekizumab treatment for 16 weeks in patients with active radiographic axial and previous inadequate response to or intolerance of 1 or 2 TNF yields rapid and significant improvements in the signs and symptoms of radiographic axial versus placebo.' (Arthritis Rheumatol 2019)
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dental decay
Treatment: D2750 white glass with high gold content crown, for tooth 18 and 15
The insurer denied coverage for D2750 white glass with high gold content crown, for tooth 18 and 15.
The denial is upheld.

Upon review of the submitted documentation which includes copies of undated full mouth series radiographs and insurer correspondence, it appears that this patient presented to the dentist for evaluation and comprehensive dental treatment. Based on the documentation, crowns were recommended for teeth #15 and #18. The insurer has denied the services stating that these services are not medically necessary treatment as the clinical documentation does not support the requested services. The patient is appealing.

Based on the submitted objective information for review, which consists solely of the radiographic examination, it is difficult to discern any radiographic issues as the quality of the radiographs is poor/inadequate. The radiographs are not of diagnostic quality and cannot be used to assess medical necessity of dental services. As this is the case, and there is no other objective clinical documentation provided for review, the radiographic documentation does not support the dental treatment recommended by the dentist. There are no dental treatment notes, no dental charting, nor periodontal charting provided for review. As the documentation is inadequate to support the treatment, these services are considered not medically necessary.

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 D2750 white glass with high gold content crown, for tooth 18 and 15 is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Other - Syncope.
Treatment: Inpatient Hospital Stay.

The health plan denied the inpatient hospital stay.  The determination is upheld.

The patient is a male with a history of anxiety, depression, gastroesophageal reflux disease (GERD), and costochondritis. He presented to the emergency room with chest pain, shortness of breath, nausea, vomiting, and syncope. The syncopal episode was witnessed by Emergency Medical Services (EMS), who noted that it was preceded by diaphoresis and vomiting. It was associated with urinary incontinence. The vital signs were unremarkable. He appeared ill and lethargic, but in no acute distress. The physical exam was otherwise normal. His labs were notable for a creatine kinase (CK) of 281, a platelet count of 88000, a glucose of 144, an indeterminately elevated Mycoplasma pneumonia immunoglobulin G (IgG), and a urine drug screen positive for cannabinoids and opiates. The portable chest x-ray was negative, and the head computed tomography (CT) scan was unremarkable. The CT scan of the chest showed diffuse ground glass and tree-in-bud opacities throughout the right lung. The electrocardiogram (EKG) was negative for acute ischemia or significant arrhythmia. The patient was admitted for further treatment and evaluation.

Upon admission to a monitored bed, the patient was treated with antibiotics and oral medications. The following day, an echocardiogram was performed and was essentially normal. The next day, the venous doppler studies of the bilateral lower extremities were negative for deep vein thrombosis (DVT). The remainder of the stay was clinically uneventful, and the patient was discharged.

At issue is the medical necessity of the inpatient hospital stay.

The health plan's determination of medical necessity is upheld in whole.

Based on a thorough review of the information provided, the requested acute inpatient stay was not medically necessary. Upon presentation, there was no objective evidence on physical exam, labs, imaging, or EKG of an imminently life-threatening cause of the patient's complaints that required acute inpatient admission. There was no hemodynamic instability, mental status changes, or severe metabolic disarray. The initial elevated potassium was most likely due to hemolysis and quickly corrected. There was no evidence of a significant cardiac or neurologic cause of the syncope. The syncope was almost certainly due to vasovagal phenomenon associated with the nausea, vomiting, and diarrhea. These symptoms were most likely side effects from an herbal supplement the patient was taking to self-medicate for anxiety. The services provided - intravenous fluids, antibiotics, oral medications - were not at the acute inpatient level of intensity. Therefore, based on the standard of care, as well as the peer reviewed literature cited in the references, the acute inpatient level of care was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: chest pain
Treatment: inpatient stay
The insurer denied the inpatient stay. The health plan's determination is upheld. 

The patient is a male who presented to the emergency department (ED) complaining of three months of intermittent chest pain and new onset dyspnea. His medical history was remarkable for hypertension. In the ED (emergency department), his blood pressure was 167/102 with a heart rate of 67 beats/minute. His respiratory rate was 14/minute with a room air oxygen saturation of 99% (percent). An electrocardiogram showed no acute changes. His serum troponin, brain (or B-type) natriuretic peptide (BNP) and D-dimer levels were normal. Head and pelvic computed tomography (CT) scans performed for a complaint of chronic left thigh numbness were unremarkable. The patient was treated with aspirin and was admitted to the hospital to rule out acute coronary syndrome. 

Based on the documentation provided, an inpatient level of care was not medically necessary.
This man presented with symptoms that were thought to be suspicious for acute coronary syndrome (ACS). Accordingly, observation until ACS could be ruled out was a reasonable approach. However, he was hemodynamically stable, with normal cardiac biomarkers, and no ischemic electrocardiographic changes. He did not require intensive monitoring or infusion of intravenous cardioactive medications. The care this patient received did not require an inpatient admission and could have been provided at a lower level of care. This approach has been shown to be both safe and effective and is in accordance with current guidelines.