Persius/hicric huggingface dataset:
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Endocrine/metabolic/nutritional/Diabetes.
Treatment:Pharmacy/Prescrition drugs.
The insurer denied Lantus solostar.
The denial is upheld in whole.

The patient with a  history of type 2 diabetes mellitus.
The coverage request is for Lantus Solostar 100/ml (3) Insulin Pen. The medication was previously denied, the formulary preferred agent is Levemir or Tresiba.
The formulary drugs Levemir and Tresiba would be as effective as Lantus.
The American Diabetes Association (ADA) 2020 standards of care and the 2019 American Association of Clinical  Endocrinologists (AACE) type 2 diabetes management guidelines do not differentiate in terms of effectiveness of basal insulins in type 1 or type 2 diabetes. Additionally, in studies regarding this topic (in type 2 patients), there did not seemed to be a significant clinical difference between basal insulins (degludec, glargine, NPH) in terms of their efficacy (Madenidou et al. 2018, Monami et al. 2008)
Additionally, Tresiba and Levemir would not have more adverse side effects. All basal insulins are associated with risk of hypoglycemia and injection site reaction. Tresiba may be associated with less hypoglycemic risk than some other basal insulins, however with appropriate technique and dosing this risk can be mitigated, and additionally hypoglycemia is not the main clinical issue of concern in this patient.
The patient has tried and failed Basaglar in the past - however similar side effects to Basaglar (diarrhea, vomiting) are not necessarily expected for Tresiba or Levemir. The coverage decision for Lantus is upheld in this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cancer /Breast cancer.
Treatment: radiation therapy.
The insurer denied Proton beam therapy with image-guided radiation therapy. 
The denial is upheld in whole. 

This patient with a history of a right breast carcinoma, post mastectomy and reconstruction followed by chemotherapy in 2012. the patient  had a recurrence in the right breast in 2019 where the patient  had resection with positive margins followed by a re-excision. Radiation therapy was recommended to the right chest to decrease her risk of recurrence. Proton beam radiation was recommended.
No, the requested treatment of proton beam therapy with image guided radiation therapy is not considered medically necessary for this patient.
The recommended proton beam radiation therapy for this patient is not considered medically necessary. This treatment is not considered a standard treatment for this diagnosis recognized by the oncologic medical community and is under clinical trials to determine the efficacy and safety as compared to standard treatments. There is currently a lack of significant studies published in peer reviewed medical literature supporting the use of proton beam radiation therapy in this clinical setting.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Endocrine/Metabolic/Nutritional.
Treatment: Pharmacy/Prescription Drugs.
The insurer denied Leuprolide. The denial is overturned.

The patient is a young female diagnosed with rapid progressing puberty. This request is for Lupron. As reported, she is a very immature child with psychiatric issues; she is taking medication for behavioral issues and cannot handle the onset of menstruation. She had a telemedicine visit due to COVID; and recently she was a tanner 3 for breasts and pubic hair tanner 2. Her bone age was advanced. Her first visit was for abnormal thyroid functions and therefore no notation was made for visual signs of central precocious puberty (CPP); she was at tanner 3 for breasts and tanner 2 for pubic hair. She is on Synthroid. The health plan denied Leuprolide as not medically necessary. 

The health plan's determination is overturned. 

The definition of precocious puberty is children who have the onset of secondary sexual characteristics younger than age 8 in girls and younger than age 9.5 in boys [1-3]. Central precocious puberty (CPP) is diagnosed using a basal LH of >0.3 or stimulation testing with a GnRH analog such as luprolide showing a pubertal response defined as an LH >5 and estradiol greater than 40 [4]. CPP is treated with GnRH agonists [5-10] such as lupron[11] and supprelin [12]. The FDA indication for GnRH agonists is for use in central precocious puberty (CPP). In addition, when used for CPP the FDA recommends discontinuation of GnRH agonists before age 11 for females and before age 12 for males [11]. 

The patient has a diagnosis of central precocious puberty. Onset of secondary sexual characteristics is not known. However, the patient had Tanner stage III for breasts at and an advanced bone age at 12 years suggesting that onset was before age 8. The patient had a pubertal LH and estradiol. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary. Given the fact that the patient also has immaturity and psychiatric issues, the requested medication should be covered.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Leg paralysis / Partial trunk paralysis.
Treatment: RT-300 Functional Electric Stimulator. 
The insurer denied the RT-300 Functional Electric Stimulator.
The denial is upheld. 

No, RT-300 Functional Electric Stimulator is not medically necessary.

The patient is a female. The patient has a history of T5 level complete paraplegia due to a recurrent dermoid cyst.  She also has a history of anxiety, hypothyroidism and breast cancer (status post bilateral mastectomy).  She has undergone therapy that has included a standing frame and a successful trial with functional electrical stimulation cycle ergometry.  Her course has been complicated by a right rotator cuff tear (which was surgically repaired) and left shoulder pain.  She uses a manual wheelchair for mobility.

A functional electrical stimulation cycle ergometer was prescribed for a primary ICD10 diagnosis of G82.21 (complete paraplegia), with neurogenic bladder, neurogenic bowels, muscle atrophy, muscle spasms and chronic pain.

The health plan patient has a history of chronic paraplegia due to a recurrent tumor.  A device to passively move her lower limbs using surface electrical stimulation to drive a stationary cycle has been prescribed.

Some preliminary literature has been published that suggests that some health benefits may potentially be attained through this type of device.  The available data, however, are inconclusive whether this type of device improves health outcomes in a clinically significant manner.  While the device appears to provide cardiovascular exercise, there are no clear indications that this passive exercise improves any clinically significant measures of health with respect to the cardiovascular, pulmonary or musculoskeletal systems.  The device, in addition, has not been proven to promote neurological recovery.  The purported benefits have largely been subjective in nature.  

There are, moreover, multiple ongoing studies in process that underscore the unproven nature of this device, including the following trials: "Functional Electrical Stimulation Cycling in Acute Spinal Cord Injury; a Feasibility Study" (NIH Clinical Trials identifier: NCT04064385); "Functional Electrical Stimulation Cycling for Managing Mobility Disability in People With Multiple Sclerosis" (NIH Clinical Trials identifier: NCT03949387); "Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking and Quality of Life in MS" (NIH Clinical Trials identifier: NCT02606604); and "Spinal Cord Injury Exercise and Nutrition Conceptual Engagement" (NIH Clinical Trials identifier: NCT03495986).

Overall, the device in question is not proven to improve health or function.  While it is approved for sale to the public by the FDA for use in this patient's condition on an empiric basis, it is not a proven treatment and, therefore, not medically necessary for the patient's condition.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Respiratory system /Asthma. 
Treatment:  Inpatient hospital. 

The insurer denied the entire hospital stay.  The denial is upheld in whole.

The patient who presented to the emergency department (ED) with complaints of shortness of breath and chest tightness for at least one day.  The patient was having complaints runny nose, body aches and a non-productive cough.  The patient  has a medical history of asthma, bipolar disorder, post-traumatic stress disorder (PTSD) and human immunodeficiency virus (HIV), as well as polysubstance abuse.

No, the requested health service/treatment of the inpatient hospital stay is not necessary at an acute inpatient level of care.

This represents a  patient with a history of asthma who has complaints of shortness of breath. The patient  has a history of asthma and was found to have some concerns for pneumonia on admission.  The  admission was complicated by the presence of substance abuse that included cocaine.  The patient is also HIV positive and is poorly compliant with  HAART therapy.  However, upon admission there was no evidence of hemodynamic compromise, hypoxemia, hypoxic respiratory failure, 'silent chest', intractable nausea or vomiting, PORT Score IV or greater, or any comorbidity that would have required an acute inpatient level of care.

Therefore, in this particular case the inpatient hospital stay is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal
Treatment: Inpatient Hospital
The insurer denied: Inpatient Stay
The denial is: Upheld in whole

The patient is a female who tripped down the stairs and sustained a fall onto her right shoulder. This resulted in a displaced rights clavicle fracture. She was admitted to the hospital, then underwent surgical fixation of the right clavicle fracture the next day. There were no complications during the procedure. Following the procedure, the patient had stable vital signs and pain was controlled. She was discharged home the following day. The subject under review is the medical necessity for the inpatient stay.

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

The inpatient hospital stay was not medically necessary for this patient. 
The rationale for this determination is based upon the provided medial records which document that this healthy female patient sustained a displaced clavicle fracture and had surgery for open reduction and internal fixation. The records show that there were no operative complications and the patient had an uneventful recovery. The inpatient hospital stay is not supported as medically necessary by the medical records.
This treatment received was consistent with the recommendations of the current, peer-reviewed orthopedic literature as documented by Ahrens and colleagues in the Journal of Bone and Joint Surgery in 2017. The provided medical records, however, do not support the medical necessity of the inpatient stay in this case. There is no documentation to explain why this episode of care could not have been completed at a lower level of care status.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chron's disease
Issue under review: Stelara (Ustekinumab) dosed every four weeks
The insurer denied the Stelara (Ustekinumab) dosed every four weeks. 
The denial is overturned. 

The patient is a male with Crohn's disease (CD). He has tried and failed treatment with Pentasa, Humira, Remicade and Entyvio. He was started on Stelara 90 mg every eight weeks. He had done well, but he lost response, with active disease on colonoscopy, and an elevated fecal calprotectin and elevated CRP (C-reactive protein). His MD is requesting to increase Stelara to 90 mg every four weeks. 

Yes, the treatment with Stelara (Ustekinumab) dosed every four weeks is medically necessary.

The patient has Crohn's disease and has been treated with Stelara 90 mg every eight weeks and has lost response. Medical literature supports dose intensification of biologics in patients who lose response to FDA-approved dosing. Stelara has been found to be safe and effective at doses as high as 90 mg every four weeks. 
Results from a retrospective cohort study of patients with CD reported that among 122 patients on ustekinumab, 21 (17%) patients on every eight week maintenance dosing required dose intensification (frequency increased to every four weeks [n=11], every six weeks [n=5], or a combination of IV booster and frequency increase to every six weeks or every four weeks [n=5]). A total of 11 patients (52%) had clinical response after dose escalation (two [18%] were primary nonresponders to induction while nine [82%] had poor initial clinical response). 

A multicenter, retrospective, open-label cohort study of adults with moderate to severe CD was conducted to evaluate the long-term maintenance efficacy of ustekinumab therapy. During the maintenance therapy, dose escalation was required in 16.3% (17/104) patients and a combination strategy of reinduction and dose escalation was required in 6.7% (7/104) of patients. The most common escalated maintenance dosing was 90 mg SC every four or six weeks. Clinical response was regained in 52.9% (9/17) of patients who had dose escalation, and 57.1% (4/7) of patients who had combined reinduction and dose escalation. Results from a retrospective, multicenter, open-label study of patients with refractory CD receiving ustekinumab, demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 mg SC every eight weeks to every four weeks [n=8], 90 mg SC every eight weeks to every six weeks [n=1]), clinical improvement was seen in 73% (8/11) of patients.

Results from a retrospective, open-label, observational study of ustekinumab for the treatment of anti-tumor necrosis factor (anti-TNF) resistant CD patients, demonstrated that, among patients who achieved clinical response at the last follow up, dose escalation was required in 35% (7/20) 
of patients who received ustekinumab 90 mg SC every eight weeks. 

Therefore, the proposed Stelara 90 mg every four weeks is medically necessary, and the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient by denying it.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Parkinson's disease, dementia, coronary artery disease, congestive heart failure, anxiety disorder and diffuse osteoarthritis. 
Treatment: Personal care aide services seven days/week, two 12-hour split shifts 
The insurer denied the personal care aide services seven days/week, two 12-hour split shifts.
The denial is overturned. 

The patient is a female with a history of Parkinson's disease, dementia, coronary artery disease, congestive heart failure, anxiety disorder and diffuse osteoarthritis. Due to impairments related to her numerous medical conditions, she requires extensive assistance for completion of the majority of her activities of daily living (ADLs). An appeal review was requested for potential approval of an increase in Personal Care Aide Services to seven days/week, two 12-hour split shift to offer increased ADL assistance.

Yes, the proposed treatment of an increase in Personal Care Aide Services to seven days/week, two 12-hour split shift is deemed medically necessary to offer increased ADL assistance.

Due to impairments related to her numerous medical conditions, she requires extensive assistance for completion of the majority of her activities of daily living (ADLs). Recent documentation from the patient's physician indicates that due to the patient's need for assistance with nocturnal toileting and history of urinary tract infections and urosepsis, it is medically inappropriate for her to wear an incontinence diaper overnight and not receive toileting assistance with the help of a personal care aide. For these reasons, the currently approved plan of personal care aide services 7 days/week, 24 hours/day live-in is not sufficient to meet the patient's current needs due to the regulated sleeping requirements for this personal care aide from the overnight period. Hence, the proposed treatment of an increase in Personal Care Aide Services to seven days/week, two 12-hour split shift is deemed medically necessary to offer increased ADL assistance.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic dermatitis
Treatment: Dupixent (dupilumab) Syn 300 
The insurer denied the Dupixent (dupilumab) Syn 300.
The denial is upheld. 

The patient is a female with atopic dermatitis, treated with topical steroids and topical calcineurin inhibitors.  Her provider is requesting Dupixent.  The patient is at 60% BSA (body surface area), and IGA (Investigator's Global Assessment) of four.

Dupilumab is United States Food and Drug Administration (FDA)-indicated for treatment of recalcitrant atopic dermatitis.  Dupilumab is a novel interleukin-four 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.  The safety and efficacy were supported in a recent meta-analysis of all published dupilumab paper.

This patient has not demonstrated an adequate trial and failure to all other standard of care measures for atopic dermatitis including those which are considered first- and second-line therapies for eczema.  Systemics such as cyclosporine can also be used in atopic dermatitis.  Patients of child bearing age can be advised of pregnancy risks and can also use oral contraceptives.  Dupixent is not appropriate or medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Central Nervous System/Neuromuscular
Nursing Services (including Private Duty Nursing)

Diagnosis: age related physical debility
Treatment: Personal Care Aide Services
The insurer denied the Personal Care Aide Services. The health plan's determination is overturned. 

The patient is a female with age related physical debility. She was initially receiving 42 hours a week of personal care services which were decreased to 35 hours a week. This review is for the medical necessity of personal care services 6 hours a day 7 days a week for a total of 42 hours a week.

The Personal Care Aide Services: Requested 42 Hours per Week, 6 Hours per Day/7 Days per Week is medically necessary for this patient.
According to the Uniform Assessment System (UAS) and tasking tool it was noted that the patient required a total of 42 hours a week of services to meet her activities of daily living (ADL) and Instrumental activities of daily living (IADL). 35 hours a week is insufficient to meet her needs.
The patient has age related physical debility. Other medical problems include anxiety, coronary artery disease, dizziness, hypertension, irritable bowel syndrome, urinary incontinence, macular degeneration and cognitive decline. According to the patient's power of attorney, the patient requested additional hours stating that the patient has weeks that she cannot get out of bed due to pain and dizziness.
The patient is able to walk independently with an assistive device. She does require assistance with ADLs and IADLs and is able to self-direct her care. The NFLOC (Nursing Facility Level of Care) decreased since prior assessment suggesting improvement in functional status.
Even though there has been a modest change in her functional status, it appears from the documentation provided that the patient still requires a total of 42 hours a week of services for ADLs and IADLs to maintain her independence. Her change in functional status did not change enough to warrant a decrease in services. Therefore, the 42 hours a week are medically necessary to meet this patient's needs.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Attention Deficit Hyperactivity Disorder-Inattentive Type 
Treatment: Mydayis 37.5MG CPTP 24HR 

The insurer denied coverage for Mydayis 37.5MG CPTP 24HR. The denial is upheld. 

This patient is a male with a diagnosis of Attention Deficit Hyperactivity Disorder-Inattentive Type and the request was for Mydayis 37.5 mg CPTP 24 hour to target Attention Deficit Hyperactivity Disorder (ADHD) symptoms. Mydayis is a mixed salt with a mixture of 3:1 dextro to levo amptheamine. It comes in dosages of 12.5, 25, 37.5, and 50 mg. It is FDA approved for ages 13 and older. It has 3 types of drug releasing beads with one intermediate and 2 different delayed release beads. It reportedly reaches peak plasma levels in 8 hours. It is advantageous for longer duration of time coverage as it is dispensed once per day. 

The medical records provided for review did not provide enough specific evidence to support that he could only take this medication, Mydayis, for the treatment of ADHD. 
The American Academy of Child & Adolescent Psychiatry (AACAP) Practice Parameters for the Assessment and Treatment of Children and Adolescents and Adults with ADHD reports that short term efficacy of psychopharmacological interventions for ADHD were well established. It also reports that stimulants were considered highly efficacious in the treatment of ADHD with up to 75% clinical responders. It states that physicians can chose from 2 stimulant types-methylphenidate or amphetamines because evidence suggests equal efficacy in the treatment of ADHD. In this case this patient reportedly tried Adderal ER and Adderall IR which is dextroamphetamine/amphetamine and he also was taking Vyvanse which is Lisdexamfetamine dimesylate and it is an inactive prodrug in which d-amphetamine is pharmacologically activated after oral ingestion and is FDA approved for ADHD. He reportedly was taking Vyvanse with dextroamphetamine. 

There were no reports that he tried a methylphenidate product, such as Ritalin LA which was reported to be on formulary. There also were no reports that he tried Atomoxetine which is a non-stimulant FDA approved medication for ADHD as it is a norepinephrine reuptake inhibitor. 

It appeared that the health care plan acted reasonably and with sound medical judgment and in the best interests of the patient. 

Based on the above, the medical necessity for Mydayis 37.5MG CPTP 24HR is not substantiated. The insurer's denial is upheld.