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

Diagnosis: Class II occlusion 
Treatment: Braces/monthly visits
The insurer denied braces/monthly visits.
The health plan's determination is upheld. 

The patient in question is a female with a Class II occlusion with 4 millimeter (mm) overjet and 6 mm overbite. The maxillary and mandibular arches have moderate crowding. She is treatment planned for orthodontics (braces/monthly visits) to correct her malocclusion. 

Braces and monthly visits are not medically necessary.
The patient has moderate crowding. Her bite is deep but there is no indication of damage to the incisors or the palate in the photographs, and her cephalometric radiograph show the lower incisors are contacting the maxillary teeth in occlusion, not the palate. There is no indication from the photographs provided there is severe soft tissue damage (or any soft tissue damage) on this patient.
There is no medical reason to correct her malocclusion with braces. The patient has a deep bite, however, that alone is not a medical necessity to treat. There are functional problems that can 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. The photographs do not illustrate any damage to the teeth or soft tissue damage from their current position. The patient has a 4 mm overjet but this amount of overjet does not affect oral health related quality of life. If her teeth were aligned it would provide a minor esthetic improvement but it would not create a medically significant improvement to the patient's health.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Asthma
Treatment: Inpatient Hospital Stay
The insurer denied the inpatient hospital stay. 
The determination is upheld. 

This is a female child with a medical history significant for moderate persistent asthma, eosinophilic esophagitis, food allergies, allergic rhinitis, and eczema who presented to the emergency department (ED) with a one-day history of increased work of breathing. She had been seen in the ED earlier that day, treated with DuoNebs and steroids for an asthma exacerbation, and discharged home. She returned to the ED for persistent wheezing unresponsive to nebulized albuterol at home. 
The examination was significant for non-toxic appearance, moist mucous membranes, tachycardia, decreased air movement, wheezing, and tachypnea. She was able to speak in full sentences, with non-focal neurologic exam. 
She was treated with magnesium, two DuoNebs, and a normal saline bolus. She was subsequently admitted because she remained symptomatic. Admission orders included continuous cardiopulmonary monitoring, regular diet, maintenance intravenous (IV) fluids, albuterol 2.5 milligrams (mg) every three hours, continued home medications (cetirizine, Singular), continued oral steroids. 
She remained hemodynamically stable throughout the hospital stay with no need for supplemental oxygen. Albuterol was gradually weaned to every four hours. She tolerated her other medications as well as her diet.  She was deemed stable for discharge to pursue allergy testing. At issue is the medical necessity of an inpatient stay. 

The inpatient stay was not medically necessary. 

Asthma is an inflammatory process characterized by airway obstruction due to airway hyper-responsiveness, bronchospasm, airway inflammation, and mucus production. Gas exchange abnormalities are due to ventilation/perfusion mismatch, as a result of atelectasis and airway over-distention. Status asthmaticus is said to occur when the patient fails to respond initially to bronchodilators and other medications administered in an emergency department (ED) setting. Asthma can still be a fatal illness if treatment is not initiated quickly or aggressively enough. 
In the ED, primary management strategies include correction of hypoxia, rapid improvement of airflow obstruction, and prevention of progression. This is achieved with supplemental oxygen, bronchodilators, and steroids. Fluid hydration may also be necessary. For patients with moderate to severe exacerbations that do not respond to such intensive therapy in the ED, admission is necessary. 
This female child with a complex and significant history including moderate persistent asthma presented to the ED for the second time in one day. She remained symptomatic despite aggressive care in the ED and was admitted for ongoing treatment. While it was reasonable and appropriate to monitor this patient in the hospital to provide ongoing care, she was overall hemodynamically stable with no need for supplemental oxygen and no evidence of impending respiratory failure. She did not require acute inpatient admission and could have been safely managed at lower level of care.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease. 
Treatment: Rinvoq. 

The insurer denied the Rinvoq. 
The determination is overturned. 

The patient is a female with a history of refractory Crohn's disease. She has tried and failed numerous therapies. 

At issue is whether the proposed health service or treatment Rinvoq 45 milligrams (mg) tablet (tab) extended release (er) 24 hours (h) 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 or treatment Rinvoq 45 mg tab er 24h likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. Rinvoq is a selective Janus Kinase (JAK) inhibitor that is being used in several immune-mediated inflammatory diseases. Rinvoq is Food and Drug Administration (FDA) approved for the treatment of ulcerative colitis in adults. The safety and efficacy of Rinvoq are well established. 

According to Sandborn, William J., et al: "8 weeks of treatment with Upadacitinib was more effective than placebo for inducing remission in patients with moderately to severely active ulcerative colitis (UC)." 

None of the JAK inhibitors is currently FDA approved for pediatric patients with ulcerative colitis or Crohn's disease. However, Rinvoq safety in children is supported by the FDA for approval of Rinvoq in treating atopic dermatitis. 

The off-label use of this class of medications in refractory cases of inflammatory bowel disease in children is reasonable. 

According to Legeret, Corinne et al: "Currently, there are a wide range of different subtype-selective JAK inhibitors under development, not only for the treatment of inflammatory bowel disease (IBD), but also for other inflammatory conditions. In the randomized, double-blinded study with Upadacitinib in patients with moderate to severe active Crohn's disease and refractory/intolerant to immunosuppressants or tumor necrosis factor antagonists (CELEST) trial, for example, in adult CD patients receiving Upadacitinib (selective to JAK1), clinical remission was achieved in 21 percent (%). So far, only very small observational cohort studies in children with IBD receiving Tofacitinib are available: of 21 patients (UC and inflammatory bowel disease unclassified (IBD-U)), 43% showed a good clinical response at the end of the 12 weeks induction, and at 52 weeks, 33% were still on Tofacitinib and steroid-free, whereas the others showed a refractory disease". 

The patient has a severe and refractory case of inflammatory bowel disease and is at risk of bowel resection. She has already tried and failed every possible therapy. The off-label use of Rinvoq in this case is reasonable and can be lifesaving. There are no reasonable alternatives in this case.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease. 
Treatment: Rinvoq. 

The insurer denied the Rinvoq. 
The determination is overturned. 

The patient is a female with refractory colonic Crohn's disease, complicated by iron-deficiency anemia, arthralgias and recurrent Clostridioides difficile infection. She has failed corticosteroids, Methotrexate, 6-Mercaptopurine, Infliximab, Adalimumab, Vedolizumab, and high-dose Ustekinumab. She has had diarrhea, hematochezia, (a few times weekly) and anemia requiring intravenous Iron. She had a colonoscopy that showed persistent moderate to severe inflammation in the colon. Surgical therapy and total parenteral nutrition are being considered. 

At issue is whether the proposed health service or treatment Rinvoq 45 milligrams (mg) tablet (tab) extended release (er) 24 hour (h) likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 

Yes, the proposed health service or treatment Rinvoq 45 mg tab er 24h likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. Rinvoq has demonstrated both safety and efficacy for the treatment of Crohn's disease in a randomized clinical trial in a study of 220 patients, which demonstrated significant increase in efficacy of all doses tested (from 3 mg daily to 24 mg twice daily) compared with placebo; efficacy was maintained at 52 weeks for most endpoints. Other long-term studies have shown the safety and efficacy of Rinvoq for the treatment of Crohn's disease. Rinvoq was approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis after demonstrating its safety in trials including several thousand patients. It has also been approved for the treatment of Ulcerative Colitis. A recent Phase 2b and Phase 3 study of high dose (45 mg) Rinvoq in Ulcerative Colitis demonstrated safety findings consistent with previous studies across indications, with no new safety risks observed. Additionally other medications with the same mechanism (Janus kinase inhibition) have demonstrated safety and efficacy for the treatment of Crohn's disease and Rinvoq has demonstrated safety and efficacy for the treatment of Crohn's disease in practice. The patient has longstanding Crohn's disease, has already failed all guideline recommended biologic therapy classes for the treatment of Crohn's disease and is at risk for complications of uncontrolled disease including stricture, fistula and the need for surgery or hospitalization. Rinvoq has a different mechanism of action than all of the medications which the patient has failed. For these reasons, Rinvoq is supported as likely to be more beneficial than any other available standard therapy for the patient's Crohn's disease in this case.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease. 
Treatment: Rinvoq. 

The insurer denied the Rinvoq. 
The determination is overturned. 

The patient is a female who has been diagnosed with Very Early Onset Inflammatory Bowel Disease (VEOIBD). She has primarily colonic involvement with a Crohn's disease phenotype. She has been treated unsuccessfully with all available therapies. These include steroids, antibiotics, 6-Mercaptopurine, Infliximab, Adalimumab, Vedolizumab and Ustekinumab. She has significant intestinal inflammation as well as extra intestinal manifestations such as joint pains. 

A recent endoscopy showed persistent moderate to severe colonic inflammation. Her treating physician, in consultation with the VEOIBD program at the Children's Hospital prescribed Upadacitinib (Rinvoq). This is a newer class of medication with a different mode of action than those previously prescribed. It is Janus Kinase Inhibitor and it has been Food and Drug Administration (FDA) approved for treatment of ulcerative colitis in adults who have failed anti-tumor necrosis factor (TNF) therapies. There is published data regarding its efficacy in treating Crohn's disease. However, the FDA has not approved pediatric use. 

All presently available pediatric therapies have been prescribed and failed. It is reasonable to try a different class of drug with a different mechanism of action. The only other alternative is surgery, which likely would require a total colectomy with an ileostomy. VEOIBD is often associated with immunologic abnormalities. 

The adult data in both ulcerative colitis and Crohn's disease is promising. There are no more "standard" treatments to be offered. Crohn's disease is often debilitating and fraught with complications such as anemia, arthritis, chronic diarrhea with subsequent electrolyte abnormalities, weight loss, growth failure, delayed onset of puberty and osteopenia. There are also significant psychologic complications as well as interfering with normal academic pursuits. 

There is a reasonable hope that Upadacitinib will decrease disease activity and improve quality of life.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Back pain
Treatment: Nerve treatment in spine (Intracept procedure)
The insurer denied the nerve treatment in spine (Intracept procedure).
The denial is upheld.

The patient is a male with complaints of mid and lower back pain. The pain has been present for several years and progressing. The pain radiates down into bilateral legs and is exacerbated with activity and improved with rest. The patient has had multiple lumbar injections. Current medications include tizanidine. Physical exam demonstrated lumbar spine decreased range of motion, pain with flexion. Magnetic resonance imaging (MRI) of the lumbar spine demonstrated multilevel degenerative changes. Diagnoses include lumbar spondylosis, vertebrogenic low back pain. The subject under review is the medical necessity for the Intracept procedure.

The health plan's determination is upheld.

The requested Intracept procedure is not medically necessary. There is a request for intraosseous basivertebral nerve ablation. This procedure is not recommended. Despite promising early reports, further trials with longer-term outcomes and less risk of bias are required. A Food and Drug Administration (FDA) investigational device exemption trial examined 225 chronic low back pain patients with type I or II Modic changes who were randomized to the requested procedure or sham treatment, resulting in decreased Oswestry disability index (ODI) of 20.5 and 15.2 points, respectively. The authors noted that these marginally clinically meaningful improvements suggested some potential as a minimally invasive treatment; however, there is lack of data to recommend this procedure as treatment modality. In general, there is lack of substantial support for this procedure, and it is currently not considered standard of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Volume depletion 
Treatment: Inpatient hospital admission
The insurer denied coverage for the inpatient hospital admission.
The denial is overturned.

This is an adult that presented to the hospital complaining of dizziness and lightheadedness as if she were going to pass out. Past medical history was significant for coronary artery disease and six stents, hypertension, and chronic obstructive pulmonary disease (COPD). Upon arrival to the hospital vital signs were stable with blood pressure (BP) 104/48 and pulse 69 beats per minute. She was subsequently noted to have a BP of 95/54. Physical exam revealed no abnormalities. Serum blood tests revealed an elevated blood urea nitrogen/ creatinine (BUN/CR) ratio (33/1.1). She was treated with 2 liters of intravenous (IV) normal saline and admitted to the hospital. She was subsequently noted to be hypertensive with systolic BP of 160 and antihypertensive medications were restarted. She was diagnosed with volume depletion and diuretic therapy was discontinued. 

This patient presented with lightheadedness and near syncope. Given her history of coronary artery disease and hypertension, cardiac syncope was a concern. The patient was treated with multiple hypertensive agents including a diuretic and BUN/CR ratio was consistent with volume depletion. Despite IV fluids, the patient continued to have symptoms. Cessation of all anti-hypertensive agents resulted in poorly controlled hypertension and medications were restarted. This patient falls into a moderate risk group for syncope.  

According to the European Society of Cardiology, patients presenting with syncope must be risk stratified for future morbidity and mortality in order to determine the need for hospital admission. (Reference 1) In a study of individuals presenting to the emergency room, patients that were moderate or high risk for cardiac events had a poor prognosis and required admission to the hospital for additional testing and treatment. (Reference 2) In this case, the patient was hypotensive even following fluid resuscitation. It is likely that the etiology of syncope was volume depletion or polypharmacy as the patient was on losartan, metoprolol, and hydrochlorothiazide medications. Admission to the hospital for treatment and risk stratification was medically necessary in this case in order to monitor blood pressure while resuming antihypertensive medications. 

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 an inpatient admission is substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous Nerve Ablation System (64628)
The insurer denied the Intraosseous Nerve Ablation System (64628)
The denial is upheld

The patient is a male with neck and back pain for several years. He had a medial branch block at L3-5 (third lumbar spine vertebra-fifth lumbar spine vertebra) with a 50% pain reduction. Physical therapy was helpful for neck but not back pain. Pain medications include cyclobenzaprine. Physical exam is positive for lumbar facet loading. MRI (magnetic resonance imaging) of the lumbar spine shows spondylosis and facet arthrosis as well as disc protrusions larger compared to previous imaging at left L4-5 (fourth lumbar spine vertebra-fifth lumbar spine vertebra) compressing the thecal sac and left L5 (fifth lumbar spine vertebra) nerve root as well a central/left disc protrusion with left and some right S1 (first sacral vertebra) nerve root compression. Request for Intracept procedure at L5 (fifth lumbar spine vertebra) and S1 (first sacral vertebra) was denied as experimental/investigational.

No, the health plan should not cover the Intraosseous Nerve Ablation System (64628).

No, the requested Intraosseous Nerve Ablation System (64628) is not more beneficial than any standard treatment for the insured condition or disease.
Review of literature shows moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic back pain who are selected based on type 1 or type 2 Modic changes as well as other inclusion and exclusion criteria used in published literature to date.  However, non-industry funded high-quality, large prospective studies are needed to confirm these findings. The requested health service or treatment is not more beneficial than any standard treatment for the patient's condition or disease.

At this time there is not enough valid scientific evidence to show that the expected health benefits from the procedure, supply, equipment, or service are clinically significant and will have a greater chance of benefit, without a disproportionately greater risk of harm or complications, than other possible treatments; and that generally approved forms of treatment that are less invasive have been tried and did not work or are otherwise unsuitable. There is a lack of sufficient (enough) peer-reviewed literature and data regarding the long-term outcomes of the procedure.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hydrocephalus affecting balance, osteoarthritis, and myelodysplastic syndrome
Treatment: Increase in Consumer Direct Personal Assistance Program (CDPAP) Services for a total of 84 hours/week
The insurer denied the increase in CDPAP services for a total of 84 hours/week.
The denial is overturned.

This female patient has conditions including hydrocephalus affecting balance, osteoarthritis, and myelodysplastic syndrome. She is appealing denial of increase in consumer direct personal assistance program (CDPAP) services for a total of 84 hours/week. The health plan approved 45.5 hours/week.  

Uniform Assessment System (UAS) evaluation completed shows the patient has modified independent cognition and functional status: total dependence with housework; maximal assistance with meal preparation, managing medication, shopping, bathing, lower body dressing, walking, locomotion, and toileting; extensive assistance with transportation, upper body dressing, and bed mobility; limited assistance with personal hygiene; and independent with phone use and eating. She has frequent bladder incontinence.  Compared to UAS evaluation completed previously, there has been a decline in all areas of physical functioning.  

The appeal letters indicate the patient needs one-to-one contact every day due to recurrent falls and assistance with activities of daily living (ADLs).

Yes, the proposed treatment is medically necessary.

Personal assistance services provide hands-on assistance to individuals to include: assistance with ADLs, health maintenance activities, and routine support services. This patient has chronic medical conditions. She is appealing the denial of an increase in CDPAP services for a total of 84 hours/week. The health plan approved 45.5 hours/week.  

The patient's UAS evaluation completed shows the patient requires assistance with all ADLs, except phone use and eating. She has frequent bladder incontinence. Compared to UAS evaluation completed previously, there has been a decline in all areas of physical functioning. Appeal statements indicate the patient needs assistance due to poor balance and recurrent falls. This patient has significant physical impairments that have progressed between UAS evaluations. The approved CDPAP services 45.5 hours/week are inadequate to meet the member's needs for assistance with ADLs/IADLs (instrumental activities of daily living). The proposed increase in CDPAP services to a total 84 hours/week is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient.

The proposed treatment is medically necessary.