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

Diagnosis: Oral Ulcer
Treatment: Hospital Admission
The insurer denied coverage for hospital admission
The denial is upheld

This patient, previously healthy, with complaints of a history of COVID-19 (2019 Novel Coronavirus) the previous month, and now a 2-week history of painful ulcers in the mouth and decreased oral intake. On examination, vital signs were within normal limits, and she had mild tachycardia (105 per minute). The Peds (Pediatric) H&P (History & Physical) physical exam documents a 0.5 centimeter aphthous ulcer on the left side of her lower gum, and no other lesions. 

On laboratory studies, she had borderline hyponatremia (sodium 134 mmol/L [millimoles per liter]) and mild metabolic acidosis (bicarbonate 17 mEq/L [milliequivalents per liter]). While she did have acute dehydration, the degree of dehydration was likely mild. The urine specific gravity was in the mid-range at 1014.  She had mild metabolic acidosis, with pH (potential of hydrogen) 7.24.  There was no documentation found regarding "intractable pain" mentioned in the hospital's appeal, nor was her clinical presentation consistent with Bechet's disease or systemic lupus. The aphthous ulcers were most likely associated with an acute viral illness. Medical decision-making mentions tired appearing with a nontender abdomen, and no adequate justification for the need for inpatient level of care. Further intravenous fluid hydration could have been administered in the emergency department, with monitoring of her electrolytes and labs within a few hours before a decision to admit could be made.

Per a widely used clinical pathway for management of dehydration from CHOP (Children's Hospital of Philadelphia), considerations for admission include failure of a trial of oral rehydration, hypoglycemia and/or significant electrolyte abnormalities, or a medical condition requiring inpatient care. Similar criteria are discussed by Flores et al in their 2020 review.

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

The insurer's denial of coverage for the hospital admission is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Central Nervous System/Neuromuscular Disorder - Dementia. 
Treatment: Home Health Care. 
The insurer denied 24 hours per day, 7 days per week (split shift) for a total of 168 hours per week Personal Care Services, Level 2.
The insurer's decision is upheld.

The patient is a male with past medical history of hypertension, diabetes, stroke, dementia and dysphagia. The patient underwent an assessment assessing the patient with modified independence with no memory problems. No hearing and no vision difficulties. The patient was assessed to require total dependence with task of meal preparation and housework, and extensive assistance with medications. The patient was assessed at extensive assistance with task of bathing, limited assistance with personal hygiene, limited assistance for dressing upper body and extensive assistance for dressing lower body, limited assistance with walking and extensive assistance for toilet transfers, independent with bed mobility and limited assistance with eating. Patient is frequently bladder incontinent and bowel continent. Patient was assessed to require 26 hours of assistance weekly. The subject under review is the medical necessity for 24 hours per day, 7 days per week (split shift) for a total of 168 hours per week Personal Care Services, Level 2.

The health plan's determination is upheld.

The requested health service/treatment of 24 hours per day, 7 days per week (split shift). Total 168 hours per week Personal Care Services, Level 2 is not necessary for this patient.
There has been a mild change in the patient's functional status based on the assessment completed. The patient is requiring more hands-on assistance and requiring some minimal assistance with bed mobility and was previously independent with this task. There are concerns for worsening cognition requiring cuing given progressive dementia, however, based on assessments, there is no documented need for assistance with activities of daily living (ADLs) and instrumental activities of daily living (IADLs). During nocturnal hours to require an increase in hours and based on the assessments, the patient requires 33 hours of services and currently has 56 hours approved. There were no new reports regarding recommendations for additional aide services which would be medically necessary for the patient above and beyond those documented with the previous nursing assessments thus the requested hours are not medically necessary per the documentation provided.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cancer - Prostate Cancer. 
Treatment: Radiation Therapy. 

The insurer denied proton beam radiation therapy. The denial is upheld. 

The patient is a male with history of clinically localized high risk adenocarcinoma of his prostate gland. Request is for definitive proton beam radiation therapy to treat the patient. The subject under review is the medical necessity for the requested proton beam therapy for this patient's condition. 

The health plan's determination is upheld. 

The requested treatment with Proton beam therapy is not medically necessary. Proton radiation is not proven to yield superior clinical outcomes as compared to standard treatment options (e.g., photon-based intensity modulated radiation therapy (IMRT) with the use of SpaceOAR hydrogel), and it is significantly more costly. The role of proton radiation therapy in the patient's setting remains controversial as some reports indicate that proton radiation may be associated with an increased risk for gastrointestinal toxicity. The patient has not previously received radiation to his pelvic region, nor does he have a genetic/comorbid condition that increases his risk for normal tissue toxicity. A high quality review (see Kamran et al.) concluded that "much-awaited contemporary studies comparing photon with proton-based treatments, with primary endpoints of patient-reported quality-of-life, will help us understand the differences between proton and photon-based treatments for prostate cancer in the modern era."
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Blood Disorder - myelodysplasia. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Venclexta. 
The denial is overturned.

The patient is a male with myelodysplasia with a complex karyotype. The blast count is 6%, giving him a diagnosis of refractory anemia with excess blasts (RAEB-1). He has been treated with azacitidine. The patient is not responding to therapy. Venclexta has been recommended as a component of therapy; this is under review for medical necessity.

The health plan's determination is overturned.

Based on DiNardo, et al's report of the benefit of venetoclax (Venclexta) in the treatment of patients with acute leukemia, there is an expanding body of literature supporting the use of this agent in high risk myelodysplastic syndrome (MDS). Data from Garcia, et al, demonstrated efficacy and safety. Its use in this case is supported by the National Comprehensive Cancer Network (NCCN) Guidelines. The only treatment recommended more highly recommended in this case by the NCCN is treatment on a clinical trial. The authors of UpToDate echo this as treatment with 14 days of venetoclax on a 28 day cycle has resulted in a response rate of 77% and an overall survival of 17.5 months with expected toxicities. This patient has failed therapy with a single agent hypomethylating agents (HMA) and for these reasons, the use of venetoclax is medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal Pain. 
Treatment: Inpatient Hospital Stay. 

The insurer denied the Inpatient Hospital Stay. 
The determination is upheld. 

The patient presented to the emergency department (ED) with right sided abdominal pain, nausea and vomiting of 3-days duration. She had a history of biliary pancreatitis for which she had recently been hospitalized (but subsequently left against medical advice). At the time of presentation, the patient was without fever and the heart rate was 113 beats /minute. She had a tender abdomen per the examination. The white blood cell count (WBC) count was elevated at 15.5 thousand (K). The complete metabolic panel showed normal bilirubin and transaminases. The lipase was elevated at 118 (it had been greater than (>) 6000 at the prior admission 3 days earlier). An abdominal ultrasound showed gallstones.
The patient underwent a laparoscopic cholecystectomy with cholangiogram. She remained clinically stable and was discharged from the inpatient setting with instructions for outpatient follow up. At issue is the medical necessity of an inpatient stay.

An inpatient level of care was not medically necessary in this case. 

This patient presented to the hospital with known cholelithiasis. The records and the diagnostic work up supported the diagnosis of cholelithiasis/cholecystitis with normalization of the lipase value that had been elevated. There is no documentation of hemodynamic, pulmonary, neurological, or metabolic reason for an acute inpatient level of care. Additionally, there is no documentation of failure to achieve discharge criteria, care for comorbidities, procedural complications, or any other condition requiring inpatient admission. Acute inpatient care was not medically necessary for this patient as the care and treatment provided could have been rendered with a lower level of care. A lower level of care would have provided for emergency department (ED) assessment, surgical consultation, monitoring, overnight care, and cholecystectomy. 

There were no hospital complications or other clinical issues that mandated an inpatient stay. She remained stable and was discharged from the hospital following surgery.
Inpatient stay may be needed for failure to achieve discharge status criteria, conversion to open surgery, systemic infection, care for active comorbidities, complications of procedure. In this case none of these conditions existed to warrant an inpatient level of care. Inpatient admission may be indicated for acute cholangitis, common bile duct obstruction, vomiting that is severe or persistent, dehydration that is severe or persistent, hemodynamic instability, severe pain requiring acute inpatient management, signs of intestinal obstruction, bacteremia, need for percutaneous or open procedures, or other condition that requires inpatient admission. In this case, none of these indications existed to justify an inpatient level of care.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Central Nervous System/Neuromuscular Disorder/General idiopathic epilepsy
Treatment:  Keppra XR 500 milligrams (mg) Tablet
The health plan denied the requested medication Keppra XR 500 milligrams (mg) Tablet as not medically necessary. 
The health plan's determination is upheld.

The patient is a man with Juvenile Myoclonic Epilepsy. The patient was initially treated with Depakote/Valproic Acid and was later switched to Keppra XR.
At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.

The health plan's determination is upheld, in whole.

Valproate is unquestionably the drug of the first choice in men with Juvenile Myoclonic Epilepsy (JME). In addition, Levetiracetam and Topiramate are effective and can be used in combination or as second line treatment. Some anticonvulsant medications may worsen JME. As such, from the available treatment options offered by the plan, there is no documentation to suggest that the patient has tried, failed, or has a contraindication to the use of Levetiracetam or Topiramate. Additionally, Briviact (which requires prior authorization) may also be effective due to its similarly with Levetiracetam. As such, there is no evidence that these available formulary drugs would not be as effective as the non-formulary drug or would have adverse effects based on the available literature for treatment of JME. Additionally, the provider asserts that the patient has been using Keppra XR, but there is not established by the available pharmacy records that do not show any paid claims for this medication over a 4+ year period. Additionally, there are no medical records provided for review.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Back pain radiating to both legs.
Treatment: Magnetic Resonance Imaging (MRI) of lumbar spine without contrast.
The insurer denied Magnetic Resonance Imaging (MRI) of lumbar spine without contrast.
The denial is overturned.

The patient is a female with a history of chronic low back pain radiating to both legs. Lumbosacral (LS) spine films revealed marked lumbar (L)5-sacral (S)1 disc space narrowing and mild thoracolumbar scoliosis. She was evaluated by the physical therapist and a 12-week program of physical therapy was started. She was seen in an office visit complaining of back and leg pain that had worsened after falling from a bed. The physical exam was notable for positive straight leg testing bilaterally. Pain medication and physical therapy were continued. A magnetic resonance imaging (MRI) was ordered. The repeat LS spine films again showed marked L5-S1 disc space narrowing that was unchanged from the prior films. The subject under review is the medical necessity for an MRI of the lumbar spine without contrast.

The health plan's determination is overturned.

The requested MRI of the lumbar spine without contrast is medically necessary for this patient. Based on a thorough review of the information provided the MRI is medically necessary. The standard of care for ordering an MRI of the lumbar spine is persistent low back and radicular pain despite a 6-8 week course of medication and physical therapy. The records document that the patient has met these criteria. Therefore, based on the standard of care, as well as the peer reviewed literature, the MRI of the lumbar spine is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Severe Refractory Atopic Dermatitis
Treatment: Dupixent 300 milligrams (mg)/2 milliliters (ml) subcutaneous (SC) solution pen injector (SOPN)
The insurer denied coverage for Dupixent 300 mg/2 ml SC SOPN.
The denial is overturned.

The patient is an adult with a past medical history significant for bullous pemphigoid, asthma, and allergic rhinitis with a diagnosis of severe refractory atopic dermatitis (AD) affecting 15% (percent) TBSA (total body surface area). The patient has failed therapy with corticosteroids, Protopic, antihistamines, prednisone, and antibiotics. The requested medication is Dupixent.  

The patient has severe AD that involves a large surface area and numerous diagnoses which would potentially be improved with Dupixent therapy. The patient requires systemic therapy given the extent of involvement and the use of Dupixent would appear to be reasonable given that it is Food and Drug Administration (FDA) approved for the treatment of atopic dermatitis. The request for Dupixent is supported by the medical literature and specialty society guidelines. Dupixent is the only systemic therapy approved by the FDA for the management of AD. The FDA approved Dupixent for adults with moderate-to-severe AD who are inadequately controlled with topical treatments (1-3). According to consensus guidelines "Dupilumab has shown strong efficacy and safety for treatment of moderate-to-severe AD... Considering the safety profiles of conventional systemic therapies, which are not FDA-approved for AD treatment, it is recommended that dupilumab be used as a first-line systemic treatment... with moderate-to-severe AD who are uncontrolled with topical therapies" (1). Furthermore, the use of Dupixent in treating pruritus associated with bullous pemphigoid as well as asthma is well documented. Dupixent is approved based on the standard of care and the provided medical documentation.   

Based on the above, the insurer's denial must be overturned. 

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

The medical necessity for Dupixent 300 milligrams (mg)/2 milliliters (ml) subcutaneous (SC) solution pen injector (SOPN) services is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Familial Mediterranean fever (FMF). 
Treatment: Ilaris. 

The insurer denied coverage for Ilaris. 
The denial is upheld. 

The patient is an adult male who has been diagnosed to with familial Mediterranean fever (FMF). In a progress note, the patient is noted to have a single (heterozygous) mutation for the Mediterranean FeVergene (MEFV), and recurrent mouth ulcers. The patient is said to be on colchicine 0.6 mg (milligrams) per day. He denies fever, joint swelling, recurrent rashes. Lab tests showed a c-reactive protein (CRP) of <.05 mg/dL (milligrams per deciliter). There were no significant abnormalities in the complete blood count (CBC). An attestation states that the patient has had "FMF flares" for years characterized by mouth ulcers, joint pain, rashes, high fevers and/or abdominal pain. And that his flares are not controlled on colchicine prophylaxis, which the patient has been taking for many years and that it is a challenge for him to adhere to colchicine in part due to gastrointestinal side effects. The health plan denial is based on the patient not having an elevated CRP. Another attestation which states that an elevated CRP should not be reason for denial as the treatment with colchicine is causing the CRP to be "falsely reassuringly low". 

According to UpToDate (Reference 1), FMF should be diagnosed if 1 major criteria or 2 minor criteria are present. The current documentation is inadequate to confirm the presence of these criteria. The progress note does not note any of the signs/symptoms that were claimed in the attestation dated later, nor are there any prior medical records which noted these. Also, the expert opinion states (reference 1) "The detection of two pathogenic mutations in the MEFV gene in an individual confirms the diagnosis." The patient has only one mutation. Thus, the diagnosis does not meet expert diagnostic criteria. 

CRP elevation is a surrogate marker of systemic inflammation. The proposed medication works by blocking interleukin 1 (IL1), a closely related systemic inflammatory marker. If CRP is not elevated a systemic immunosuppressant which can lead to infections should not be given, especially when colchicine, a very safe drug, seems to be working. 

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 Ilaris services is not substantiated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Postmenopausal Atrophic Vaginitis
Treatment: Estring vaginal ring 2 milligrams (mg) 
The health plan denied:  Estring vaginal ring 2 milligrams (mg) 
The health plan's determination is: Upheld.

This patient is a female who is under consideration for Estring vaginal ring 2 milligrams (mg) for the indication of postmenopausal atrophic vaginitis. She is noted to have been on this medication after undergoing a hysterectomy. She reports itching and burning with Estrace and Premarin cream. She has a remote history of endometriosis that led to a hysterectomy. In this case, there has been no documented trials and failures of any of the preferred formulary alternative agents.

The health plan's determination is upheld. 

Based upon a review of the indication for the use of Estring 2 mg vaginal ring, as postmenopausal atrophic vaginitis, there would be no lack of effectiveness for the use of the formulary drugs of Estradiol patch, Estradiol tablet, Premarin cream, Menast tablet, Premarin tablet or Yuvafem for estrogen replacement in this patient post hysterectomy. 
Each of these formulary agents has the same active ingredient of estrogen for replacement in the case of post hysterectomy estrogen deficiency leading to atrophic vaginitis. In this case, the patient is postmenopausal due to hysterectomy in the setting of endometriosis and has atrophic vaginitis. She is noted to vaginal atrophy resulting in dyspareunia due to her postmenopausal state. Vaginal atrophy is a direct consequence of the hypoestrogenic state associated with menopause resulting in anatomic and physiologic changes in the genitourinary tract. The North American Menopause Society estimates that 10-40% of menopausal women will experience one or more symptoms of vaginal atrophy. Vaginal atrophy causes bothersome vaginal symptoms commonly associated with menopause including, vaginal or vulvar dryness, discharge, itching, and dyspareunia. Estrogen therapy effectively alleviates atrophic vaginal symptoms related to menopause. Local therapy is advised for the treatment of women with only vaginal symptoms. All low-dose systemic estrogen formulations are Food and Drug Administration (FDA) approved for the treatment of atrophic vaginitis. Oral dosages of conjugated Equine Estrogen as low as 0.3 milligrams/deciliter (mg/d) and transdermal Estradiol dosages of 12.5 micrograms/deciliter have demonstrated improvements in vaginal atrophy. Local vaginal estradiol and local conjugated equine estrogen, which can be administered in cream, ring, and tablet formulations, are effective in treating atrophic vaginitis in menopausal women. This application can provide relief from menopausal symptoms of vaginal atrophy and dyspareunia. Each of the formulary drugs is an option for control of these symptoms and would be both effective and not likely to cause side effects/adverse effects. In this case, the formulary drugs have not been proven to have adverse effects in the management of atrophic vaginitis.