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

Diagnosis: Autism Spectrum Disorder, Intellectual Disability
Treatment: 13 hours of applied behavioral analysis a week
The insurer denied: 13 hours of applied behavioral analysis a week
The denial is: Upheld

The patient is a male. According to a letter by a clinical psychologist the patient has autism spectrum disorder and profound intellectual disability.  On the Vineland Adaptive Behavior Scales 3rd Edition his adaptive skills fell below the 1st centile, with an overall Adaptive Behavior Composite of 40. The letter stated that the gold standard approach for children with the patient's profile of autism and profound intellectual disability is 25-40 hours of applied behavioral analysis (ABA)-based therapy per week.

A letter by the patient's mother describes that he has improved in some areas with ABA, while other areas remain significantly delayed. He has had episodes of regression when there has been a lapse in ABA therapy, including when the patient's therapist was away for a month, reducing his therapy to 4 hours per week. He had a return of episodes of bowel incontinence, and disruptive behavior, particularly at school.

At issue in this review is the medical necessity for additional 13 hours of ABA therapy per week.

The requested additional 13 hours a week of direct ABA therapy is not medically necessary for this patient. The patient has received quite intensive ABA therapy for 7 years. He has made minimal progress, meeting 12 out of 42 goals. It appears unlikely that the provision of an additional 13 hours per week of ABA will result in significant improvement. While there is reasonable data supporting the use of ABA to improve development and behavior in younger children [1], there are fewer published reports supporting efficacy with increased hours in older children.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alcohol withdrawal, liver disease
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The determination is overturned.

The patient has with a past medical history (PMH) of severe alcohol abuse, hypertension, hypertension (HTN), and pre-diabetes who was admitted with complaints of (c/o) alcohol withdrawal. The vital signs were unremarkable. The physical exam was notable for no apparent distress (NAD), no focal neurologic deficits. Lab work notable for ethanol of 268, aspartate aminotransferase (AST) / alanine aminotransferase (ALT) 3057/1817. The patient was diagnosed with alcohol withdrawal and alcoholic hepatitis and treated with intravenous (IV) benzodiazepines (BZDS) and clinical monitoring. The patient was discharged against medical advice (AMA). At issue is the medical necessity of an inpatient level of care.

The hospital stay was medically necessary at an acute inpatient level of care. The patient had a medical history and physical exam clinically concerning for acute alcohol intoxication in the setting of alcohol hepatitis. This presentation was further compounded by the patient's symptoms requiring chemical sedation, a total of 16 milligrams (mg) in 24 hours, and these types of patients are not appropriate for a lower level of care due to the close clinical monitoring that is required to ensure no respiratory depression and adverse events, especially in the setting of clinical concern for delirium tremens. Due to the patient's medical history, he required close clinical monitoring for evidence of respiratory depression and complications of alcoholic hepatitis, including hepatic encephalopathy, renal failure or hepatorenal syndrome, ascites due to portal hypertension and bleeding tendencies due to coagulopathy and/or thrombocytopenia, and could not have been safely provided at a lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic sinusitis  with nasal polyps 
Treatment: Dupixent Syn 300
The health plan denied the requested medication, Dupixent Syn 300 as not medically necessary. 
The health plan's determination is overturned.

The patient is a female with chronic rhinosinusitis with nasal polyps (CRSwNP) status post several sinus surgeries. She has tried several biologics with partial response. She previously had been on Dupilumab with a reportedly good response, but this was stopped. Her physician wants to restart. She is also taking intravenous immunoglobulin (IVIG) for common variable immunodeficiency (CVID). The request was denied.
At issue is the medical necessity of the requested treatment of Dupixent Syn 300.

I overturn, in whole, the health plan's determination of medical necessity.

Yes, the requested treatment of Dupixent Syn 300 is medically necessary for this patient. Dupilumab has been shown to be the most effective treatment for nasal polyps among all of the biologics approved according to the recent CRSwNP guidelines. It has been shown to reduce sinus surgery, reduce polyp size and improve smell.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Breast Cancer
Treatment: Agendia Breast cancer test suite: MammaPrint and BluePrint genetic testing.
The insurer denied the Agendia Breast cancer test suite: MammaPrint and BluePrint genetic testing.
The determination is upheld.

This is a patient with newly diagnosed left breast cancer. Imaging studies and a core needle biopsy showed infiltrating ductal carcinoma Grade 2, estrogen receptor (ER)positive, progesterone receptor (PR) negative, human epidermal growth factor receptor 2 (HER2) negative, 2.3 centimeters (cm) in size on magnetic resonance imaging (MRI). An axillary lymph node biopsy was positive for metastatic disease.

She has a family history of a maternal grandmother with breast cancer and maternal aunt with either ovarian or vaginal carcinoma. Genomic testing was performed on the core needle sample with MammaPrint and BluePrint. These showed a luminal type breast cancer with a high risk of recurrence.

Genomic testing was performed to determine if neoadjuvant chemotherapy would be appropriate or if upfront surgery would be more appropriate. At issue is the medical necessity of the Agendia breast cancer test suite: MammaPrint and BluePrint genetic testing.

Genomic testing can be very useful in determining the value of chemotherapy. In this case, however, the request for testing was on a core needle sample. It was not possible based on this information to determine how many axillary lymph nodes are positive in this patient. Studies for genomic testing have shown validity for those with 1-3 nodes positive.

In this case without knowing the true positive node number, the test should have been deferred until postoperative (postop). There is not sufficient evidence to offer genomic testing when complete nodal status is not known.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Stereotypies. 
Treatment: Ingrezza. 

The insurer denied Ingrezza. 
The denial is upheld. 

The patient is female with cerebral palsy and intrusive stereotypies who is requesting treatment with Ingrezza. The drug was denied because the indication is off label. The provider appealed the determination. 

The subject under review is the medical necessity for Ingrezza for this patient. 

The requested treatment with Ingrezza is not medically necessary for this patient. The indication of stereotypies is not Food and Drug Administration (FDA) approved or compendia supported. The indication is not recognized by the manufacturer. The physician included literature on the use of vesicular monoamine transporter-2 (VMAT2) inhibitors for the treatment of hyperkinetic movement disorders. The patient specifically has stereotypies. In a review article on the use of VMAT2 inhibitors for treatment of hyperkinetic movement disorders, the article indicates that valbenazine (Ingrezza) has been examined for treatment of tardive dyskinesia and Tourette syndrome. The study does not address the use of valbenazine in patients with cerebral palsy and/or stereotypies. (1) In the other study submitted for review, 135 patients with hyperkinetic movement disorders were examined. The study only including 3 patients with stereotypies, and it is unknown if any of those were treated with valbenazine; out of 135 patients 29 were treated with valbenazine for all indications. (2)
While the literature may support the use of VMAT2 inhibitors in general for treatment of stereotypies, there is a specific lack of evidence showing that valbenazine is safe or effective for treatment of stereotypies. There is no evidence from controlled trials. There is no evidence of a large cohort study on stereotypies. As such, given a lack of specific evidence for the use of this drug for this condition, it is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Status Post Heart Transplant
Treatment: Prevymis (Letermovir)
The insurer denied: Prevymis (Letermovir)
The denial is: Overturned

The patient is a male status post heart transplantation. He is reported as cytomegalovirus (CMV) -(negative)/+(positive), Epstein-Barr virus (EBV) +, toxoplasmosis -/+, hepatitis C virus (HCV) nucleic acid test (Nat) + status post Simulect x 1.
His posttransplant course was noted for acute kidney injury with a lowered Tacrolimus dosing. He is maintained on hepatitis-C treatment. His medications include Zarxio, Keppra, Tacrolimus, CellCept, Valcyte (prior) and Prednisone (wean), and Mepron.
His white blood cell count is 1.7. He has received Neupogen for neutropenia. According to the encounter note, the patient is maintained on Valcyte until he can start Letermovir. He is reported to have had an episode of CMV viremia which is not further detailed in the records. He is being prescribed a Letermovir for CMV prophylaxis given a history of neutropenia, Acute Kidney Injury and concomitant medications which could exacerbate this and other side effects of Valcyte.

The issue under review is the medical necessity for Letermovir for prophylaxis in this patient.

The health plan's determination is overturned.

The Prevymis (Letermovir) is medically necessary for this patient.  This patient has several high-risk features for CMV infection and requires prophylaxis. He is not tolerating Valcyte due to neutropenia. Continuing treatment with Valcyte places him at risk for other infections in order to continue prophylaxis.

Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality in the heart transplant community. Nearly all transplant centers practice some form of prophylaxis (whether universal or preemptive), though duration of prophylaxis can vary. The patient has leukopenia from Valcyte use in addition to other medications. To continue this medication places, him at risk for serious opportunistic infections. Substitution with Letermovir is reasonable, effective and used in multiple studies. Alternatives include Quantiferon-CMV for CMV-specific immune monitoring which the records do not indicate was performed. Under more personalized approaches to CMV titers and detecting CMV deoxyribonucleic acid (DNA) are plausible but not widely accepted and should not be used in the setting of prior CMV infection. Lastly, newer medications with less data in thoracic transplant are available but without indications. It is clear that this patient has failed Valcyte with complications of neutropenia in the setting of basiliximab and renal insufficiency. The use of CMV prophylaxis in the setting is not controversial and the agent best suited for this task in this patient is Letermovir.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Trauma, fall from bunk bed
Treatment: Inpatient hospital admission
The insurer denied coverage for inpatient hospital admission
The denial is upheld.

This is a young child who presented to the emergency department after falling from a bunk bed.  Records indicated that there was a small abrasion to the posterior scalp.  Immediately after the fall, the mother rushed to see her child on the floor crying and reported no loss of consciousness. The history and physical report noted a small approximately 1 cm (centimeter) abrasion to the posterior scalp with no active bleeding. The patient was neurologically intact and had a c (cervical)-collar in place.  Vital signs were stable with a report indicating that the patient denied nausea, vomiting, chills, fever, or blurry vision. The radiology report was negative for intracranial injury

Based upon the Milliman Care Guidelines, the patient did not require acute care. While the child sustained a fall and had an abrasion to the scalp, there were no neurological symptoms and was hemodynamically stable with no intracranial abnormalities on imaging. The claim that further work-up could not be conducted on an outpatient basis was incorrect as this required no more than observation care given the presenting symptoms and findings on clinical assessment.  

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

Diagnosis: Sleep Apnea
Treatment: Sleep Study (continuous positive airway pressure [CPAP] titration)
The insurer denied: Sleep Study (continuous positive airway pressure [CPAP] titration)
The denial is: Upheld.

The patient is a male who was referred to the sleep lab for the treatment of sleep apnea. The patient history of morbid obesity with body mass index (BMI) of 39.2 and hypertension. The patient had a home sleep study that showed mild sleep apnea with an apnea hypopnea index (AHI) of 6.6. The treating provider is requesting the coverage of an in lab continuous positive airway pressure (CPAP) titration to treat the patient mild sleep apnea. The patient has history of gastroesophageal reflux disease (GERD).

The health plan's determination is upheld.

The requested health service/treatment of sleep study (CPAP titration) is not medically necessary for this patient. Patil et al. did a systematic review to provide supporting evidence for the clinical practice guideline for the treatment of obstructive sleep apnea (OSA) in adults using positive airway pressure (PAP). The meta-analysis include 336 studies that met inclusion criteria. The data demonstrated the initiation of CPAP in the home (in form of auto CPAP) demonstrated equivalent effects on patient outcomes when compared to an in-laboratory titration approach. The data also demonstrated that the use of auto-adjusting or bilevel positive airway pressure (PAP) did not result in clinically significant differences in patient outcomes compared with standard continuous PAP.

This patient suffers from mild sleep apnea. The patient has history of hypertension. There is no evidence that the patient failed or has contraindication to home auto CPAP. The patient does not have any medical (i.e., chronic obstructive pulmonary disease   [COPD] or congestive heart failure [CHF], neuromuscular disorder..) or sleep (i.e., narcolepsy, central apnea, ..) comorbidities that would degrade the accuracy of an auto- CPAP. There is no evidence that the patient failed auto CPAP. The latter is as adequate as an in lab sleep study titration study for treatment of sleep apnea. Therefore, the in lab CPAP titration study is not medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Hematuria
Treatment: CxBladder Detect test
The insurer denied the CxBladder Detect test.
The health plan's determination is upheld.

The patient is a female with diagnosis of microscopic hematuria. A CxBladder test was performed to evaluate the diagnosis. This is under review.

The CxBladder Detect test is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

CxBladder is a novel multiplex mRNA (messenger ribonucleic acid) assay(uRNA) for the diagnosis and stratification of urothelial cancer. It uses polymerase chain reaction amplification to quantify 4 mRNAs from unfractionated urine. Only one study has evaluated the efficacy of this test in patients with gross hematuria. The study was done in Australasia and was funded by the manufacturer of the test. Until larger randomized studies are published, CxBladder is not indicated for diagnosis or management of bladder cancer.

In addition, AUA Guidelines on microhematuria do not recommend use of urine cytology and urine markers as a part of the routine evaluation of patients with asymptomatic microscopic hematuria. The guidelines state, "Clinicians should not use urine cytology or urine-based tumor markers in the initial evaluation of patients with microhematuria.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Hematuria
Treatment: CxBladder Detect test
The insurer denied the CxBladder Detect test.
The health plan's determination is upheld.

This patient is a female with microscopic hematuria. She has not had gross bleeding. She has had more than one cystoscopy with improvement over time. She does not have risk factors for bladder cancer; she is not a smoker. Cxbladder testing was performed and is topic of this review.

The CxBladder Detect test is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Current guidelines of the American Urologic Association (AUA) do not endorse the use of urinary biomarkers in the evaluation of microscopic hematuria. In addition, current literature supports the position of the AUA. The use of the CxBladder test does not improve long term health outcomes. Therefore, it is not indicated in this case.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Hematuria
Treatment: CxBladder Detect test
The insurer denied the CxBladder Detect test.
The health plan's determination is upheld.

This is a non-smoking female with microscopic hematuria. She had a Cxbladder assay performed. This is the subject under review.

The CxBladder Detect test is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

According to the National Comprehensive Cancer Network (NCCN) Guidelines, "Most of these tests have a better sensitivity for detecting bladder cancer than urine cytology, but specificity is lower. However, it remains unclear whether these tests offer additional information which is useful for detection and management of non-muscle invasive bladder tumors."

Chou's meta-analysis concluded that "Urinary biomarkers miss a substantial proportion of patients with bladder cancer and are subject to false-positive results in others. Accuracy is poor for low-stage and low-grade tumors."
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Pain due to sickle cell disease
Treatment: Inpatient Hospital Stay
The insurer denied the Inpatient Hospital Stay.
The determination is upheld.

The patient has a history of sickle cell disease, asthma, recurrent pain crises, 20 plus (+) emergency room (ER) visits, and opiate abuse disorder, who presented to the emergency room (ER) with bilateral knee pain, right hip pain and right shoulder pain. He took 4 tablets of 20 milligram (mg) oxycodone with little relief. He had no shortness of breath (SOB), new cough, fever, chills, nausea, or vomiting. In the emergency room (ER), he was hemodynamically stable. His chest x-ray was clear and his lab results including hemoglobin (Hb) were stable. He had a mildly elevated reticulocyte count. He was admitted and given intravenous (IV) hydration. He was continued on home opiate medications. He was given additional IV Toradol. He also had an episode of slightly low systolic blood pressure (SBP) of 88 that improved with IV hydration. It was thought to be from methadone use. He eventually improved and decided to pursue outpatient management by his hematology team and primary care physician (or provider) (PCP). An inpatient level of care is under review for medical necessity.

The inpatient stay was not medically necessary.
The patient was admitted and was given IV hydration. He was continued on home opiate medications. He was given additional IV Toradol. He also had an episode of slightly low SBP of 88 that improved with IV hydration. It was thought to be from methadone use. He was eventually discharged home where he was to continue to follow up with his PCP and hematology team. He did not meet criteria for inpatient admission as his pain was not far from baseline. He was seeking opiates that were not provided to him considering his history. His pain regimen was not changed. He was only given two doses of IV Toradol that was reasonable within observation level of care. He did not have any complication of sickle cell crisis such as acute chest syndrome, aplastic crisis, splenic sequestration, infection, priapism, hand-food syndrome, encephalopathy, that would make him a candidate for inpatient admission [1,2]. Per the Milliman Care Guidelines (MCG) Health Inpatient & Surgical Care 26th Edition Sickle Cell Disease ORG: M-331 (ISC) he had no seizures, stroke, visual disturbances, chest pain, hypoxemia, cough, pneumonia, acute kidney injury, aplastic crisis, traumatic hyphemia that would make him candidate for inpatient admission [3]. As noted above, his pain was not far from his baseline. He was suitable for a lower level of care with subsequent transition to outpatient care. An inpatient admission was not indicated. He was not far from his baseline. He did not have any signs and symptoms of a vaso-occlusive crisis. His pain was at his baseline, and he was maintained on his pain regimen. The care provided to the patient was appropriate for a lower level of care.