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

Diagnosis: Asthma
Treatment: Dupixent
The insurer denied the Dupixent
The denial is overturned.

The patient is a female with moderate to severe asthma, nasal polyposis, allergic rhinoconjunctivitis. She is prescribed dupixent. The patient has been on advair, nesonex, certriline, albuterol without adequate control. Patient has tried and failed Xolair.

Coverage for dupixent was denied by the health plan due to lack of medical necessity. This denial is being appealed.

Yes, the requested Dupixent is medically necessary.
Dupilumab has been shown to increase lung function and reduce severe exacerbations in patients with uncontrolled persistent asthma irrespective of baseline eosinophil count. Thus, addition to inhaled corticosteroids plus long-acting 2-agonist therapy could improve the lives of patients with uncontrolled persistent asthma compared with standard therapy alone. To date, there is the strong need to compare the efficacy across the monoclonal antibodies (mAbs) approved to treat severe asthma. All the investigated mAbs were more effective than placebo in reducing the risk of exacerbation and improving lung function. Dupilumab showed a general superiority compared to the other mAbs (monoclonal antibodies), as it significantly reduced the risk of exacerbation vs. omalizumab, and significantly improved FEV1 (forced expiratory volume 1 second) when compared to omalizumab, mepolizumab, and benralizumab. Since the patient's asthma is inadequately controlled with current treatments, the addition of dupixent is medically necessary.

In adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP), dupilumab reduced polyp size, sinus opacification, and severity of symptoms and was well tolerated. These results support the benefits of adding dupilumab to daily standard of care for patients with severe CRSwNP (chronic rhinosinusitis with nasal polyps) who otherwise have few therapeutic options.  Since the patient has both severe persistent asthma and CRSwNP (chronic rhinosinusitis with nasal polyps) and has tried and failed all the available treatments, the addition of dupixent is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cardiac/Circulatory Disorder- heart failure .
Treatment: Inpatient Hospital. 
The insurer denied inpatient stay. 
The denial is overturned.

This male presented to the emergency department (ED) complaining of dyspnea, orthopnea and lower extremity and scrotal edema. His medical history was remarkable for coronary artery disease, coronary artery bypass graft surgery, mitral valve replacement, heart failure with reduced ejection fraction (20-25%), hypertension, hyperlipidemia, pulmonary embolism, schizoaffective disorder, and noncompliance with his prescribed medical regimen. In the ED his blood pressure was 136/78 millimeters of mercury (mmHg) with a heart rate of 108 beats/minute. His respiratory rate was 16/minute with a room air oxygen saturation of 98%. His physical exam was remarkable for morbid obesity and lower extremity edema. An electrocardiogram showed sinus tachycardia and an age-undetermined anteroseptal myocardial infarction. His serum sodium level was 133 millimoles per liter (mmol/L). His N-terminal pro brain natriuretic peptide (BNP) level was 3579 picograms per milliliter (pg/ml). His serum troponin I level was .056 nanograms per milliliter (ng/ml); it was .057 ng/ml when repeated. His hemoglobin level was 10.7 grams per deciliter (gm/dl). The patient was treated with intravenous furosemide and admitted to the hospital for treatment of decompensated heart failure. He had pulmonary rales and persistent lower extremity edema. His troponin I level was .060 ng/ml. He was seen by a cardiologist who recommended restarting his previously prescribed Entresto and twice daily intravenous furosemide. However, the patient removed his intravenous catheter, refused to take his medication, and threw his belongings around his hospital room. Since he refused treatment, he was discharged from the hospital. Medical necessity for an inpatient admission is at issue.

The health plan's determination is overturned.

This patient presented with acute decompensated heart failure (ADHF). He was tachycardic with several other high-risk features, including hyponatremia, serum troponin elevation and anemia. In patients hospitalized with ADHF, hyponatremia is associated with increased in-hospital and post-discharge mortality, prolonged hospital length of stay, and frequent rehospitalization. Likewise, serum troponin elevations in these patients have been shown to be associated with higher odds of in-hospital mortality (odds ratio 2.19), greater length of stay and lower likelihood of discharge to home, independent of other clinical predictors and measured confounders. The patient's anemia also increased his risk for adverse outcomes, including mortality and prolonged hospital stay. Given this patient's multiple high-risk features, careful and continuous monitoring with the ability to intervene emergently, if needed, was medically necessary. This warranted an inpatient level of care.
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 man with hypertension (HTN), paroxysmal atrial fibrillation, congestive heart failure (CHF), status/post (s/p) implantable cardioverter defibrillator (ICD) placement, obstructive sleep apnea (OSA), cocaine and alcohol use who presented to the emergency room (ER) with chest and upper abdominal pressure, dyspnea and dizziness. Vital signs were stable (Blood pressure 104/67 millimeters of mercury (mm HG), pulse 87 beats per minute (bpm), and respiratory rate 17. Oxygen saturation was 98% on room air). Troponin was 0.101. An electrocardiogram (EKG) showed atrial pacing - unchanged from the previous admission. Brain (or B-type) natriuretic peptide (BNP) was 2660. He was admitted and received intravenous Lasix, 40 mg. Symptoms improved over the next 24 hours, and he was discharged.

The inpatient hospital admission was not medically necessary. The patient was hemodynamically stable, with non-diagnostic troponin levels, no diagnostic EKG changes for ischemia or infarction, and atypical chest symptoms. He remained stable and symptoms resolved within 24 hrs.
A lower level of care was appropriate. The patient was hemodynamically stable and with no objective evidence for a serious cardiac or pulmonary diagnosis that would require inpatient admission, such as pulmonary embolus, aortic dissection, or acute myocardial infarction.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Acute Migraine. 
Treatment: Nurtec 75MG orally disintegrating tablet (ODT). 

The insurer denied Nurtec 75MG orally disintegrating tablet (ODT).  The denial is upheld.

The patient is a female with acute migraine.  Treatment with Nurtec orally disintegrating tablet (ODT) is the subject of this review.  The drug was denied because there was not documentation of trial and failure of 3 triptans.  Only documentation of rizatriptan use (with no documentation of failure) was provided.  The provider indicated in a letter of medical necessity that sumatriptan and naratriptan were also used.  The denial of Nurtec ODT was appealed.  The subject under review is the medical necessity for Nurtec.

The requested treatment is not medically necessary. Nurtec ODT is appropriately prescribed for treatment of acute migraine.  The plan's formulary alternatives include sumatriptan, naratriptan, zolmitriptan, frovatriptan, eletriptan, and almotriptan.  The plan asserts that the member has not tried and failed triptans.  There are no outpatient notes indicating that the patient has used 3 triptans.  There are only outpatient notes indicated that the patient has tried Maxalt (rizatriptan) without any documentation of failure.

Based on the outpatient notes, there is insufficient documentation of failure to any triptan.  Maxalt (rizatriptan) is included on the patient's medication list.  However, there is insufficient documentation that the member has failed Maxalt.  That is, there is no documentation that Maxalt is not effective for treatment of the patient's migraines.  Moreover, there are no outpatient notes to show that the member has tried and failed other triptans, notably, sumatriptan and naratriptan.

Triptans are considered first-line treatment for acute migraine.  There is a paucity of evidence to show that Nurtec ODT is superior to triptans.  Failure to respond to one triptan does not predict failure to all other triptans.

Furthermore, the office notes indicate that the member is treated with Aimovig, which is a monoclonal Calcitonin gene-related peptide (CGRP) inhibitor.  Nurtec ODT is a small molecular CGRP inhibitor.  Data are lacking to show that the combination of a monoclonal CGRP inhibitor and a small molecular CGRP inhibitor is a safe or effective approach to treatment of migraine due to similar mechanisms of action.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis.
Treatment: Dupixent.
The insurer denied the Dupixent.
The denial is overturned.

The patient is a female with atopic dermatitis to the face, neck, trunk and extremities, 30% BSA (body surface area). She has been treated with topicals (steroids and calcineurin inhibitors), prednisone, and antibiotics.  Her provider is requesting Dupixent.

Yes, the requested Dupixent is medically necessary.
Dupixent is the only systemic medication with an FDA (United States Food and Drug Administration) approval for this condition. Dupilumab is United States Food and Drug Administration indicated for treatment of recalcitrant atopic dermatitis and can potentially make a significant impact of this patient's life. Dupilumab is a novel interleukin-4 and interleukin-13 blocker, which inhibits the arm of the immune system responsible for atopic dermatitis. In clinical trials, after 12 weeks of monotherapy with dupilumab, 85% of patients had a greater than 50% reduction in eczema severity and pruritus scores decreased by 57.1%. In phase III clinical trials, dupilumab led to a 75% improvement in eczema severity, when compared to placebo, and decreased symptoms of anxiety and depression. It also led to a significantly decreased use of topical corticosteroids.  This patient has severe disease and phototherapy would not be appropriate given the facial involvement.  Systemic immunosuppressants carry greater risk in the current Covid pandemic.  Therefore, Dupixent is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Anterior crossbite with gingival attachment loss. 
Treatment: D8080 braces and D8670 monthly visit (x [times]12). 

The insurer denied coverage for D8080 braces and D8670 monthly visit (x12). 

The denial is upheld. 

Upon review of the submitted documentation including lateral cephalometric radiograph, panoramic radiograph, montage of extraoral and intraoral clinical images, treatment records, as well as insurer correspondence, it appears that this patient presented for evaluation for orthodontic care. The orthodontist recommended comprehensive orthodontics due to anterior crossbite with gingival attachment loss (mandibular central incisors), among other clinical findings. The Orthodontist has completed the Handicapping Labio-Lingual Deviation (HLD) index as required and has chosen the automatically qualifying condition of crossbite of individual anterior teeth when clinical attachment loss and recession of the gingival margin are present, to support orthodontic necessity. 

It is evident that the patient exhibits a malocclusion. However, to assess for severity of the malocclusion and therefore medical/dental necessity for orthodontic care, a Handicapping Labiolingual Deviation Index is utilized. This index provides six specific conditions that automatically qualify for orthodontic care. Additional criteria are used utilizing a point system if none of these initial qualifying conditions are met or selected. For these other secondary criteria to qualify for orthodontic care a total score of 26 points is necessary. 

In this case, the treating orthodontist claims an automatic qualifying condition of crossbite of individual anterior teeth when clinical attachment loss and recession of the gingival margin are present. This reviewer finds that this automatically qualifying condition criterion is not met as there is no evidence of gingival attachment loss or gingival recession and therefore does not support comprehensive orthodontic care using this criterion. In this case, the clinical circumstance does not meet insurer and plan criteria to justify orthodontic care. This reviewer concurs with the HLD index of the insurer attaining 18 points (16 anterior open bite, 2 labiolingual spread). 
 
Regarding the validity of the Handicapping Labiolingual Index, it has been shown through scientific scrutiny in peer reviewed journals that this methodology for assessing orthodontic need is a valid approach. 

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

The insurer's denial of coverage for the D8080 braces and D8670 monthly visit (x12) is upheld. Medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned


Diagnosis: Crohn's disease
Treatment: Stelara
The insurer denied Stelara. 
The health plan's determination is overturned. 

This patient is a female with a history of Crohn's disease. She also has arthritis. She has tried and failed Humira and antibiotics. Under review is the medical necessity of Stelara.

Stelara is medically necessary for this patient.
Stelara is approved by the Food and Drug Administration (FDA) for the treatment of Crohn's disease and ulcerative colitis in adults. Despite the lack of FDA approval for pediatric patients, there are many peer reviewed publications supporting the efficacy and safety of Stelara in children with inflammatory bowel disease.
Chavannes M et al, reported a multi-centered cohort study supporting the safety and efficacy of Stelara in pediatric patients with Crohn's disease.
A report by Dayan JR et al, showed that ustekinumab (Stelara) is efficacious and safe in pediatric patients with inflammatory bowel disease.
J Rosh et al, recently published a multi-center, double-blind, induction dose-ranging study in pediatric patients with Crohn's disease. The study supported the safety and efficacy of Stelara in this patient population.
The clinical practice guidelines support the use of Stelara in pediatric Crohn's patients who failed TNF (tumor necrosis factor)-alpha inhibitors. Therefore, Stelara's use in children with Crohn's disease is appropriate and well supported by peer reviewed evidence.
This patient has a history of refractory Crohn's disease which failed anti-tumor necrosis factor alpha (Humira). She is unlikely to respond to infliximab as it has a similar mechanism of action to Humira. Therefore, Stelara is the most appropriate treatment for this child.
Appeal type: Medical necessity
Decision: Overturned


Diagnosis: Alopecia areata universalis.
Treatment: Xeljanz.
The insurer denied Xeljanz. 
The health plan's determination is overturned. 

The patient is a male with severe alopecia areata universalis, from which the patient has lost all of the hair on his body, face, and almost all of the hair on his scalp. The patient has tried and failed topical, intralesional, and oral steroids for his condition. The patient also has severe eye irritation/inflammation from the lack of eyebrows and eyelashes and cannot participate in most activities of daily life as a result. The clinical records support and confirm the ocular lesions of this patient.
Health plan coverage of Xeljanz is under review for medical necessity.

Xeljanz is medically necessary for this patient.
The patient's ocular symptoms from the loss of eyebrows and eyelashes poses the main, if not only, significant functional and medical symptom associated with alopecia areata universalis. The painful and discomfort will force a patient to be indoors and affect any quality of life and daily activities due to the loss of eyelashes and eyebrows, and these structures are meant to protect the eyes. Without them, potential corneal inflammation and impairment of vision throughout the day are likely and frequent. No other treatment save Xeljanz has any significant, safe, and effect medication to reliably and in a time-tested experience over several years treat alopecia areata (despite Xeljanz being off-label for alopecia areata.)
Because of the ocular, vision-impairing, and painful symptoms of this particular patient with alopecia areata universalis that risks long-term corneal inflammation, Xeljanz is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Coronary artery disease, chronic ischemic heart disease, constipation, hypertension, polyneuropathy, osteoarthritis

Treatment: Personal Care Aide (PCA) level 2, 12 hours per day, 7 days per week, total of 84 hours per week

The insurer denied coverage for Personal Care Aide (PCA) level 2, 12 hours per day, 7 days per week, total of 84 hours per week.

The denial is overturned.

The patient has a history of coronary artery disease, chronic ischemic heart disease, constipation, hypertension, polyneuropathy, osteoarthritis and incontinence (bladder and bowel). Per the Uniform Assessment System (UAS), a reassessment was performed due to a significant change in status. Assistance with activities in daily living (ADLs) is needed, including extensive assistance with personal hygiene, bed mobility, toilet use, and maximal assistance for walking, bathing, toilet transfers and meal preparation. She is frequently incontinent of bladder and occasionally of bowel. 

New York Codes Rules and Regulations, Title: Section 505.14 Personal care services; notes:

"(a) Definitions and scope of services.
(1) Personal care services means assistance with nutritional and environmental support functions and personal care functions, as specified in clauses (5)(i)(a) and (5)(ii)(a) of this subdivision. Such services must be essential to the maintenance of the patient's health and safety in his or her own home, as determined by the social services district in accordance with this section; ordered by the attending physician; based on an assessment of the patient's needs and of the appropriateness and cost-effectiveness of services specified in subparagraph (b)(3)(iv) of this section; provided by a qualified person in accordance with a plan of care; and supervised by a registered professional nurse. "

Increased services are not needed for safety and supervision as stand-alone functions. The patient needs extensive-maximal assistance with all functions. The patient recently had a fall due to her trying to transfer and go the bathroom by herself without assistance. Bed mobility is impaired and she cannot clean herself alone when incontinent or using the bathroom. 

The provision of diapers and durable medical equipment (DME) is not by itself adequate for prevention of pressure sores. As noted in "Preventing pressure ulcers" in www.ncbi.nlm.nih.gov/books6430/ changing diapers regularly and positioning are also 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 Aide (PCA) level 2, 12 hours per day, 7 days per week, total of 84 hours per week is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental Disorder
Treatment: Braces and monthly visits times 12.
The insurer denied Braces and monthly visits times 12.
The determination is overturned.


The patient has buccal (reverse) crossbite on teeth number (#) 12 and #13 and a deep bite. Tooth C is overretained. She presents with a skeletal Class I malocclusion with maxillary and mandibular crowding. She is treatment planned for 24-30 months of orthodontics. At issue is the medical necessity of braces and monthly visits times 12.
The services are medically necessary. Because teeth 12 and 13 are in buccal crossbite, they have no antagonists. As a result, it is extremely likely that these teeth will overerupt. Once this overeruption occurs, it is very difficult to treat. (1) Buccal crossbite (also known as scissor-bite in the literature) can also negatively affect mandibular growth and should be treated as early as possible to eliminate the potential growth disturbance. (2)
If left untreated, the damage that will likely occur to the patient's teeth will be much more time consuming to correct than the patient's existing orthodontic problem. For these reasons treatment is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Multiple Sclerosis
Treatment: glatiramer acetate injection 40 mg/mL
The insurer denied glatiramer acetate injection 40 mg/mL.
The determination is upheld.

The patient has multiple sclerosis and has previously tried and failed dimethyl fumarate due to lymphopenia. She has used generic glatiramer acetate but developed welts on the skin and flu-like reactions. The medical necessity of treatment with Copaxone (glatiramer acetate) 40 milligrams per milliliter (mg/mL) is the subject of this review. 

The requested glatiramer acetate injection 40 mg/mL is not medically necessary for this patient. The formulary alternatives include Rebif, Extavia, Avonex, Aubagion, Gilenya, Mazyent, Plegridy, Ocrevus, and Tysabri.
The patient does not have an absolute contraindication to the use of Gilneya or Mayzent. A concern for opportunistic infections is not a absolute contraindication or a reason that establishes medical necessity for glatiramer acetate. The patient does not have an absolute contraindication to the use of interferon based medications such as Avonex, Extavia, Rebif, or Plegridy. The provider notes that the member has anxiety / depression. Neither of these diagnoses are addressed in the medication documentation. The patient is not on any pharmacotherapy (such as a selective serotonin reuptake inhibitor (SSRI)) for treatment of anxiety or depression. As such, this does not establish medical necessity for glatiramer acetate. Compelling or absolute contraindications to Ocrevus or Tysabri are not provided.
All of the plan formulary medications are safe and effective for treatment of relapsing multiple sclerosis. The plan's formulary includes oral, injectable, and infusion drugs and first- and second-line agents. The plan's formulary includes highly effective drugs, if indicated and required. The patient does not have an absolute contraindication to the use of all of the plan's formulary alternatives.