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

Diagnosis: Peyronie's disease
Treatment: Collagenase clostridium injections (Xiaflex)
The insurer denied coverage for collagenase clostridium injections (Xiaflex)
The denial is overturned

This case involves an adult under review for Xiaflex.  Progress note reported the patient was being seen for Peyronie's and erectile dysfunction.  Examination noted approximately 3 centimeter (cm) palpable area of plaque on each side of the penis.  The patient was given Xiaflex injection on the right.  The patient followed up and received Xiaflex injection on the left.  Clinical note reported the patient felt an improvement in the bend to the left and indention.  It was noted the patient continued to have greater than 30%(percent)-degree curve to the left.  The patient was given repeat Xiaflex injections. Follow-up reported the patient felt improvement. Determination letter reported the injections were not medically necessary.  It was noted that the provider indicated that symptoms were present for a few months and the patient had reports of painful intercourse.  However, given the lack of penile ultrasound, the procedure was not medically necessary.

Xiaflex is a combination of bacterial collagenases Food and Drug Administration (FDA) approved for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. In this case, the patient was noted to have Peyronie's disease with a curvature deformity of at least 30 degrees at the start of therapy. It was noted that the patient's condition was present for several months and there was evidence of functional deficit to include pain with intercourse.  Therefore, the injections performed were medically necessary in this case.

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 collagenase clostridium injections (Xiaflex) is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Crohn's disease

Treatment: Zeposia 7- day starter pack str pack cap

The insurer denied coverage for Zeposia 7- day starter pack str pack cap

The denial is upheld

 
The patient has Crohn's ileitis. She has previously failed Stelara and Humira. Her physician is requesting treatment with Zeposia. The physician maintains that she will likely not respond well to vedolizumab or Entyvio. She enrolled in a multicenter trial of Ozanimod but did not meet eligibility for the trial. 

The New England Journal of Medicine 2021; 385:1280-1291 has an article titled "Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis." The article reports that Ozanimod was more effective than placebo in induction and maintenance of patients with moderate to severe ulcerative colitis. Crohn's patients were not studied in this trial. 

Contemporary Clinical Trials 2022 Nov; 122:106958 has an article titled 
"Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The Yellowstone clinical trial program." This study will provide information on whether Ozanimod will be useful for Crohn's patients. However, at this time, there are no results in this study for either induction or maintenance therapy for Crohn's disease. 

This patient has Crohn's disease and has failed biologic therapies. There are other biologic agents that are recommended by the American College of Gastroenterology for moderate to severe Crohn's disease. At this time, there is no randomized trial that has been completed that has shown that Ozanimod is effective for Crohn's disease. 

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 Zeposia 7- day starter pack str pack cap is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dysmenorrhea
Treatment: Lo Loestrin Fe
The insurer denied Lo Loestrin Fe.
The determination is upheld.

This is a female patient with dysmenorrhea. There is a note that she has tried Tri-Femynor and Depo Provera and stopped secondary to symptoms of nausea and vomiting. The patient would like to take Lo Loestrin Fe for her diagnosis. At issue is the medical necessity of the requested medication.

The requested Lo Loestrin Fe is not medically necessary for this patient.

The patient is utilizing a combined oral contraceptive for primary dysmenorrhea and has tried one oral contraceptive and one progesterone injectable in the past with symptoms; however, there is no indication that the patient has tried any other formulary combined oral contraceptive for contraception nor any analgesics like ibuprofen, Naproxen, or celecoxib for dysmenorrhea. Lo Loestrin is a combined oral contraceptive with alternatives. The health plan has formulary alternatives for dysmenorrhea to include ibuprofen, Naproxen, and celecoxib. There is no documentation that these medications have been attempted or are ineffective in controlling her symptoms. In addition, there are no current American College of Obstetricians and Gynecologists (ACOG) guidelines that list one medication as superior to another when treating dysmenorrhea. Therefore, the requested medication is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Dermatitis.
Treatment: Dupixent 300mg (milligrams)/2mL (milliliter) SC (subcutaneous) pen injector SC (subcutaneous) Sig: Inject 1 pen (300 milligrams) SC (subcutaneous) every week; Quantity: 6 Milliliter with refills:11.
The insurer denied: Dupixent 300mg (milligrams)/2mL (milliliter) SC (subcutaneous) pen injector SC (subcutaneous) Sig: Inject 1 pen (300 milligrams) SC (subcutaneous) every week; Quantity: 6 Milliliter with refills:11.
The denial is upheld.

The patient is an adult male with atopic dermatitis, greater than 5% body surface area to the trunk and lower extremities, treated with topical steroids, topical calcineurin inhibitors and Dupixent every 14 days. The provider is requesting Dupixent weekly. The patient has been limiting use of topical steroids due to striae.

The proposed treatment is not medically necessary.

Randomized controlled trials for dupilumab did not find a significant difference in response to weekly dosing compared with that to every other week (EOW) dosing. There is an article by Gao et al who performed a cohort study to examine the real-world experience for recurrence of atopic dermatitis (AD) prior to the next dose of dupilumab and how patients on weekly dosed dupilumab did in the cohort, all of whom were inadequately controlled on the approved dosing. This was a small study with only 23 patients. The 23 patients who had tried weekly dupilumab were called, with 17 patients completing the survey. It was observed that 12/17 patients (71%) reported recurrence prior to their next dupilumab dose, and all of them (100%) claimed that increasing every other week dosing of dupilumab to every week dosing helped control their symptoms, this benefit was worth the effort of injecting oneself twice as often, and they planned to remain on weekly dosing. From this study, weekly dosing of dupilumab may be beneficial to some patients with atopic dermatitis (AD), particularly those experiencing a recurrence of atopic dermatitis symptoms on the standard dosing. However, the study only had 23 patients; larger studies are needed.
The randomized, double-blind, phase III clinical trial (Worm et al) showed that continued response over time was most consistently maintained with dupilumab administered weekly or every two weeks. Longer dosage intervals and placebo resulted in a diminution of response for both continuous and categorical end points. No new safety signals were observed. The approved 
regimen of 300 milligrams (mg) of dupilumab every two weeks is recommended for long-term treatment. The trial did not note a significant difference between weekly and every other week dosing. 
Therefore, given that only one small study showed a benefit in patients receiving weekly dosing, the request cannot be considered within standard of care at this time, and is therefore not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Coronary artery disease, hypertension and arthritis
Treatment: Personal care worker (PCW) service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week
The insurer denied coverage for PCW service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week
The denial is reversed.

This is an elderly adult with chronic medical problems including coronary artery disease, hypertension, and arthritis. She lives alone in a 2-bedroom apartment. The insurer approved PCW services 13 hours/ day, live in/7 days a week, totaling 91 hours/week. The patient is requesting PCW service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week.

The recent Uniform Assessment System (UAS) report was reviewed. The patient's cognitive skills are described as modified independent. She is fully oriented and can activate her personal emergency response system (PERS) in an emergency. She requires maximal assistance for bathing, lower body dressing and toilet transfer. She is totally dependent for toilet use and frequently bowel/bladder incontinent. 

The patient's clinical condition and functional ability has significantly declined, according to the clinical records (subsequent to the August Uniform Assessment System (UAS). The patient was recently hospitalized and underwent cervical spine surgery. A letter from her treating physician also notes her recent cervical spine surgery. The patient's limited functional mobility, falls risk, need for frequent repositioning in bed were also discussed. The patient's medical condition requires the requested PCW service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week. 

The healthcare plan did not act reasonably, with sound medical judgment or in the best interest of the patient. PCW service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week is medically necessary.

Based on the above, the insurer's denial must be reversed. 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 personal care worker (PCW) service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week services is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Coronary artery disease, hypertension and arthritis
Treatment: Personal care worker (PCW) service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week
The insurer denied coverage for PCW service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week.
The denial is upheld.

This is an elderly adult with chronic medical problems including coronary artery disease, hypertension and arthritis. She lives alone in a 2-bedroom apartment. The insurer approved PCW services 13 hours/ day, live in/7 days a week, totaling 91 hours/week. The patient is requesting PCW service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week.

The recent Uniform Assessment System (UAS) report was reviewed. The patient's cognitive skills are described as modified independent. She is fully oriented and can activate her personal emergency response system (PERS) in an emergency. She requires maximal assistance for bathing, lower body dressing and toilet transfer. She is totally dependent for toilet use and frequently bowel/bladder incontinent. The patient's medical condition and functional needs are not at a level or unpredictable as to require the requested PCW service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week. Due to safety concerns the patient may actually require additional monitoring. However, safety monitoring under personal care services does not include monitoring an individual when no other Level I or Level II personal care services task is being provided. The approved live-in PCW should be able to obtain uninterrupted 5 hours of sleep over the course of the 24-hour work cycle. Based on the enclosed documents reviewed, the patient's health and safety can be appropriately provided and maintained at home with the approved PCW services 13 hours/ day, live in/7 days a week, totaling 91 hours/week.

From a physical medicine and rehabilitation perspective, PCW service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week is 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 PCW service 12 hours/day x 7 day/week x 2 split shift/ 7 days a week, totaling 168 hours a week services is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: respiratory distress
Treatment: inpatient stay
The insurer denied the inpatient stay. 
The health plan's determination is overturned.

The patient is a boy who presented to the emergency department with respiratory distress. He was well until the day of presentation when he awoke with fever, coughing, and shortness of breath. He was given acetaminophen and his temperature came down, but he continued to be short of breath and therefore was brought to the emergency department for care.

In the emergency department, he was found to be tachypneic and in acute distress with decreased air movement and rhonchi. He was given 3 albuterol/Atrovent nebulized treatments as well as Decadron. Laboratory values and a chest x-ray were obtained. Upon re-evaluation, he continued to be tachypneic with rhonchi noted in the lower lung fields. After treatment his oxygen saturation went down to 90-91% with a heart rate of 171 and subcostal retractions. He therefore also given magnesium sulfate and supplemental oxygen by nasal cannula. He was subsequently admitted to the hospital for further care.

Inpatient Hospital Admission was medically necessary for this patient.
This is a young boy who presented with new-onset respiratory distress. He continued to have tachypnea and retractions despite appropriate and intensive treatments in the emergency department, including 3 albuterol/atrovent treatments, intravenous corticosteroid, and magnesium, and he had an episode of hypoxemia with oxygen saturations as low as 90%. He therefore required hospital admission for continued intensive treatments, initially with bronchodilators every 3 hours, as well as intravenous solumedrol and continuous monitoring. He improved the next day but continued to have tachypnea and wheeze and was still felt to require intravenous solumedrol and monitoring.
The decision making at the time of admission for this patient was consistent with his young age, the presence of respiratory distress and hypoxemia with persistent symptoms after appropriate emergency treatment, and the need for ongoing management with initial frequent bronchodilators, parenteral therapies, and close monitoring for potential deterioration of clinical status.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Congestive heart failure
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission
The denial is upheld 
 
The patient has a history of mitral valve regurgitation and congestive heart failure. She presented shortly after midnight with shortness of breath, orthopnea, and dizziness. She had tachypnea and crackles on lung examination. She was admitted and treated with furosemide. Later that day her blood pressure (BP) was 92/51. It was repeated a few minutes later and was 88/45. At 6 PM (evening) it was 93/49. At 8 PM it was 105/52. At 4 AM (morning) the following day it was 110/63 and remained stable. There was no sign of acute ischemic disease. Other vital signs were normal.

The patient was stable within 48 hours of arrival and could have been discharged after an observation stay.      

Treatment included an angiotensin receptor blockers (ARB) medication. There was no sign of acute ischemic disease. Other vital signs were normal. The patient was stable within 48 hours of arrival and could have been discharged after an observation stay.

As noted by King, et al (2022), "For select patients with acute decompensated heart failure, it may be possible to treat them at home depending on the severity of symptoms."  

As noted by Yancy, et al (2017), "The use of ARBs might be considered to decrease hospitalizations for patients with preserved ejection fraction"                                                         

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 hospital admission is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Bronchiolitis
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission
The denial is overturned

This is an infant with a history of wheezing in the past, who was sick for 6 days with a cough and chest congestion. On the day of admission, he began to have difficulty breathing which did not improve with treatment at home with albuterol. His mother noted that he had a decrease in oral intake and a decrease in urine output. She also indicated that he was crying inconsolably so she brought him to the emergency room (ER) for treatment.

In the ER he was noted to be in respiratory distress with an increased respiratory rate and abdominal retractions. He was noted to have diffuse wheezing and diminished breath sounds at the lung bases upon examination of the chest. He was treated with an intravenous (IV) bolus of normal saline, oxygen supplementation, prednisone and three back-to-back treatments with albuterol and Atrovent. He continued to have wheezing and increased work of breathing and a pulse oximeter reading of 92 when sleeping. Respiratory syncytial virus (RSV), influenza and Coronavirus disease (COVID) testing was negative. When there was no improvement in his respiratory distress, wheezing and increased work of breathing the decision was made to admit him to the hospital with a diagnosis of bronchiolitis and a plan to continue oxygen and albuterol inhalation treatments every 2 hours.

The infant was treated appropriately in the ER for respiratory distress with tachypnea and hypoxemia, with multiple combination nebulizer treatments, prednisone, IV fluids and oxygen supplementation when his pulse oximeter was 92percent (%) on room air. The infant did not improve with home therapy with albuterol. The decision to admit for continued nebulized albuterol every 2 hours was consistent with the standard of care for a child with a history of previous wheezing and respiratory distress related to a viral illness. 

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

The insurer's denial of coverage for the hospital admission is overturned. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

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

This is a female patient with a past medical history (PMH) of hypertension (HTN), diabetes mellitus type 2 (DM2), sarcoidosis, chronic kidney disease (CKD), and left adrenal mass who was admitted with complaints of (c/o) dizziness with (w/) standing. Her vital signs were unremarkable. The physical exam was unremarkable. Lab work was notable for a creatinine of 2.09, mildly elevated troponin, and leukocytosis. Imaging studies included a computed tomography (CT) scan of the abdomen/ pelvis (A/P) showed multiple opacities in the left lower lobe (LLL), left adrenal mass, colonic thickening consistent with (c/w) colitis. The patient was diagnosed with colitis and dehydration and treated with intravenous fluids (IVF), IV antibiotics, a proton pump inhibitor (PPI), and liquid diet. Cardiology evaluated the patient and cleared the patient for surgery without additional work-up. The patient was discharged in stable condition. At issue is the medical necessity of an inpatient level of care.

The hospital stay was not medically necessary at an acute inpatient level of care. This patient presented to the emergency department (ED) with c/o dizziness w/ standing with some reported diarrhea. The patient did not have associated high-risk features, such as severe acute renal failure, congestive heart failure, or liver failure, nor did the patient have any hemodynamic instability, bowel obstruction, diabetic ketoacidosis, appendicitis, pyelonephritis, ascending infection, toxic appearance, unstable vital signs, or immunosuppression. The patient did have a mildly elevated troponin, but cardiology recommended no additional acute intervention or work-up. The patient presented with colitis with dehydration, was treated and responded to IVF and IV antibiotics, and these interventions could have been safely and appropriately provided at a lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Class II malocclusion. 
Treatment:  Full braces and periodic orthodontic treatment. 
The insurer denied full braces and periodic orthodontic treatment.  
The denial is overturned.

The patient is a female. She has a Class II malocclusion with spacing and severely protrusive maxillary incisors. She has an approximately 9-millimeter (mm) overjet according to her cephalometric radiograph. She is treatment planned for orthodontics to correct the spacing and protrusion, the requested services were denied on the basis that treatment is not medically necessary.

The requested braces and orthodontic treatment are medically necessary for this patient. Teeth #8 and #9 are protruding forward within the dental arch. This makes them more prone to trauma. There is strong medical evidence that that correction of patients with prominent maxillary front teeth can reduce the risk of incisor trauma. (1) Closing the space present will make the teeth significantly less protrusive, reducing the risk of trauma. Evidence shows orthodontic treatment will reduce the chances of damage to the maxillary incisors and the associated costs and morbidity of repairing these teeth. Furthermore, there is scientific evidence that oral health quality of life is reduced in patients with a 6+ mm overjet, which this patient has. (2) For these reasons orthodontic treatment is deemed medically necessary.