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

Diagnosis: Central Nervous System/Neuromuscular Disorder.  
Treatment: Cancer Treatment. 

The insurer denied an electric tumor treatment field (TTF). 
The denial is upheld. 

The patient was or is enrolled in a clinical trial. As part of a clinical trial, a treatment is experimental and investigational and under further study to determine safety and efficacy. As such, these services cannot be medically necessary during the clinical trial. If the patient did not have progression of disease as part of the clinical trial, the on-going treatment is generally provided as part of the clinical trial. 
Approval in the United States, Europe, and elsewhere was based on results of a clinical trial that randomly assigned 237 patients with recurrent glioblastoma to TTFields or clinician's choice chemotherapy. The majority of patients were enrolled at the time of second or greater recurrence and approximately 20 percent had received prior bevacizumab. Median progression-free and overall survival were similar in those treated with TTF versus chemotherapy (2.2 versus 2.1 months and 6.6 versus 6 months, respectively). The objective response rate was nonsignificantly higher in patients treated with TTF compared with chemotherapy (14 versus 10 percent). Quality-of-life data available in only 27 percent of patients were similar between groups. Mild to moderate scalp dermatitis related to transducer arrays was the most common device-related side effect (16 percent). Hematologic and gastrointestinal adverse events, primarily mild or moderate, occurred in 20 percent of those treated with chemotherapy and less than 3 percent of device-treated patients. 
A subsequent open-label randomized trial in patients with newly diagnosed glioblastoma showed prolonged progression-free and overall survival in the group assigned to TTF when used in combination with post radiation temozolomide.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriasis. 
Treatment: Stelara. 

The insurer denied Stelara. The health plan's determination is upheld. 

The patient is a male with psoriasis throughout his body (at least 20% body surface area involvement, and including the groin and scalp), as well as psoriatic arthritis of the hands and wrists. The patient has tried and failed high-potency topical steroids and calcipotriene, ultraviolet B (UVB) light therapy and Otezla. The patient has responded well to Stelara, and health plan coverage of Stelara therapy is under review. 

Stelara is not medically necessary for this patient. 

The patient has no documented treatment failure with, or true medical contraindication to standard, first-line systemic therapies such as either Methotrexate (the standard first-line therapy for both moderate-severe psoriasis and for psoriatic arthritis), Acitretin (beneficial for the skin but not for the joints), and/or Phototherapy (helpful for psoriasis to non-sensitive areas, but not for the joints). Particularly for a patient with a limited history of systemic psoriasis and psoriatic arthritis therapy previously utilized, these preferred agents are appropriate for this patient's clinical scenario. Therefore, the requested Stelara is not medically necessary.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Embolism and Thrombosis
Treatment: Formulary exception for Eliquis
The insurer denied the Formulary exception for Eliquis
The denial is overturned

The patient is a female with diagnosis of "embolism and thrombosis of unknown artery." The patient had been on anticoagulant for approximately 10 years including warfarin, Xarelto, and most recently Eliquis. Clinical reasons for switch of medications was not defined, but the patient has tolerated Eliquis for the last several years.

Yes, the health plan should cover the Formulary exception for Eliquis.
Recent data and guidelines reflect the increased safety profile of Eliquis as compared to both warfarin and Xarelto.

Patients treated with rivaroxaban (Xarelto, Janssen) demonstrated a 40% higher overall risk for GI (gastrointestinal) bleeding and a 50% higher risk for major GI (gastrointestinal) bleeding than those treated with apixaban.

In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. In routine practice, apixaban is more effective and safer than rivaroxaban with a lower rate of strokes, systemic embolism, and major bleeding. Apixaban is safer than rivaroxaban, with significantly less major bleeding, any bleeding or gastro-intestinal bleeding. Apixaban is evidenced to likely be the safest DOAC (directly acting oral anticoagulants) of the four available.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Stelara.
The denial is overturned. 

The patient is a female with Ulcerative Colitis (pancolitis). She has failed oral and rectal mesalamine, prednisone, budesonide, azathioprine, adalimumab, and vedolizumab. She started Stelara with good response. She has had increased symptoms of active disease (cramping abdominal pain and bloody diarrhea), elevated fecal calprotectin at 1,379 micrograms (mcg)/gram (g), and elevated serologic inflammatory markers (C-reactive protein and erythrocyte sedimentation rate). Testing showed a Stelara level of 19 microgram (ug)/milliliter (mL) and lack of anti-Stelara antibodies. The patient is recommended for Stelara 90 milligrams (mg) every 6 weeks for the treatment of Ulcerative Colitis.
At issue is the medical necessity of Stelara subcutaneous (SQ) 90mg.

The health plan's determination of medical necessity is overturned in whole.

The requested health service/treatment of Stelara SQ 90mg is medically necessary for this patient.
The request for Stelara 90mg every 6 weeks is supported as medically necessary. The patient has failed multiple conventional and biologic therapies; she then had improvement on Stelara. [1-3] Stelara has shown efficacy for the treatment of Ulcerative Colitis in a Phase III trial, UNIFI. [1,4] This trial demonstrated that a single intravenous dose of Stelara induced clinical remission in a significantly greater proportion of patients than placebo did, as measured by both clinical response and endoscopic response; this result was attained in a patient population which was 50% biologic-refractory. Recent studies have demonstrated that Stelara 90mg every 4 weeks is safe and well-tolerated for the treatment of inflammatory bowel disease, with recovery of effectiveness in patients with active disease. [5-7] A recent study showed that 43% of Ulcerative Colitis patients on Stelara required dose escalation, and over 50% of those with dose escalation achieved corticosteroid-free remission, and long-term improvement in endoscopic inflammation. [8]
In this case, the patient has Ulcerative Colitis, and has failed multiple guideline-recommended alternatives, with active disease symptoms and objective markers of active disease after initial response to Stelara. As the patient had initial improvement on Stelara with subsequent loss of response, dose increase to Stelara 90mg every 6 weeks is supported. Continuation of the current dose of 90mg every 8 weeks or a discontinuation of Stelara (even if an alternative is immediately attempted) may result in ongoing symptoms and complications such as toxic megacolon, dysplasia leading to colorectal cancer, hospitalization, or need for surgery. For all of these reasons, the request for Stelara 90mg every 6 weeks is supported as medically necessary and appropriate for the treatment of this patient's Ulcerative Colitis.
Therefore, the requested health service/treatment of Stelara SQ 90mg is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cancer. 
Treatment: Radiation Therapy. 

The insurer denied Proton Beam Therapy. 
The denial is upheld. 

This patient is a male, who presented with locally advanced Prostate cancer. He is being evaluated by his provider, with curative intent radiation using Proton beam. 
At issue is the medical necessity of Proton Beam Therapy. 

The health plan's determination of medical necessity is upheld in whole. 

The requested health service/treatment of Proton Beam Therapy is not medically necessary for this patient. 

The treatment of prostate cancer in the United State which is in accordance with generally accepted standards of medical practice in the United States is intensity modulated radiation therapy (IMRT). Proton beam treatment is being evaluated under National Cancer Institute (NCI) sponsored trials. 

The use of Proton Beam radiation therapy as definitive treatment for prostate cancer has medical literature with relatively short follow up with proton beam therapy as monotherapy for prostate malignancies. These studies show equivalent control rates to other types of radiation therapy for the shorter follow up periods. There are also retrospective studies with large numbers of patients that have shown worse gastrointestinal (GI) side effects as compared to photon beam radiation therapy with IMRT. There is a lack of randomized studies regarding proton beam radiation therapy alone as treatment for prostate cancer that show equivalent outcome or any improvement over other forms of radiation therapy such as photon IMRT. Until the current randomized trials ongoing are published in peer reviewed medical literature, this treatment for prostate cancer is considered investigational and not medically necessary. 

Therefore, the requested health service/treatment of Proton Beam Therapy is not medically necessary.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: atopic dermatitis (AD).
Treatment: Adbry.
The insurer denied Adbry. 
The health plan's determination is upheld.

The patient is a female with atopic dermatitis (AD). Body surface area affected is 30%. She has tried and failed methotrexate, prednisone, Protopic, Elidel, and Eucrisa per the appeal letter. She has tried and failed Dupixent and triamcinolone. However, no medical record documentation has been provided to substantiate these failures. 

A formulary exception is not indicated. There is no documentation provided that the patient has tried and failed, has a contraindication to, or intolerance to the preferred therapy Rinvoq.
A study of Rinvoq for the treatment of moderate to severe atopic dermatitis showed that Rinvoq is efficacious in the treatment of atopic dermatitis.  Beck et al writes "Upadacitinib treatment for 16 weeks resulted in significant improvements in pruritus as early as day 2. The positive benefit/risk profile of upadacitinib supports proceeding to phase-3 trials in AD."  Simpson et al writes in "Efficacy and Safety of Upadacitinib in Patients With Moderate to Severe Atopic Dermatitis Analysis of Follow-up Data From the Measure Up 1 and Measure Up 2 Randomized Clinical Trials" that "In this analysis of follow-up data from 2 randomized clinical trials, longer-term treatment of adolescents and adults with moderate to severe atopic dermatitis with upadacitinib demonstrated a favorable benefit-risk profile, with sustained efficacy responses through 52 weeks". Silverberg et al writes "Results through 52 weeks demonstrate long-term maintenance of efficacy and a favorable safety profile of upadacitinib + TCS (topical corticosteroid) in patients with moderate-to-severe AD".
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hypertension, hypothyroidism, congestive heart failure, dementia, anemia, depression, sarcoidosis, osteoporosis, osteoarthritis. 

Treatment: Personal Care Aide (PCA) Services Level 2: 12 hours per day, 7 days per week; 12 hours per day, 7 days per week (split shift) for a total of 168 hours per week. 

The insurer denied coverage for Personal Care Aide (PCA) Services Level 2: 12 hours per day, 7 days per week; 12 hours per day, 7 days per week (split shift) for a total of 168 hours per week. 

The denial is overturned. 

It was noted the patient lives alone in a three-bedroom house with six steps to enter, and she has a history of wandering in the house at night. The patient was also admitted due to a urinary tract infection and COVID-19 (2019 Coronavirus). She was transferred to a skilled nursing facility for therapy services. She is totally dependent for meal preparation, ordinary housework, managing finances, managing medications, managing stairs, shopping, transportation, dressing her lower body, locomotion and toilet use. The patient is incontinent of bladder and occasionally incontinent of bowel. She uses incontinence supplies. A physician letter supports the above and notes in addition she already has a pressure ulcer. The dementia prevents her from using the commode. The patient uses an assistive device for locomotion.  A separate medical assessment notes moderate to severe dementia as well as paranoid delusions. The patient needs maximum assistance with phone use, bathing, personal hygiene, dressing her upper body, walking and toilet transfer. A note clearly states that she needs to get up multiple times at night or be changed. This is confirmed by night time logs. 

An increase to personal care aide (PCA) services Level 2: 12 hours per day, 7 days per week; 12 hours per day, 7 days per week (split shift) for a total of 168 hours per week
is supported. 

Based on the professional findings and recommendations, the medical necessity for the requested 168 PCA hours is supported. 

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

The insurer's denial of coverage for Personal Care Aide (PCA) Services Level 2: 12 hours per day, 7 days per week; 12 hours per day, 7 days per week (split shift) for a total of 168 hours per week is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriatic Arthritis.
Treatment   Rasuvo 12.5 milligrams (mg)/0.25 milliliter (ml) sub cutaneous solution auto- injector (SC SOAJ)
The insurer denied coverage for Rasuvo 12.5 mg/0.25 ml sub cutaneous solution auto- injector (SC SOAJ)

The denial is overturned.

This case involves a female patient diagnosed with psoriatic arthritis, gastroesophageal reflux disease (GERD), carpal tunnel syndrome, right transcarpal ligament release, diabetes, hypertension, and degenerative disc disease.

The patient was seen regarding a history of psoriatic arthritis, with pain in the hands, knees, and ankles.  The elbows were overall less active and morning stiffness was noted.  Stiffness lasted 20 to 30 minutes.  On examination, there was tenderness and edema present.  Tenderness was present in the right wrist.  There was tenderness in the lumbar and right hip.  Range of motion of the lumbar spine and right hip are decreased.  

The patient was recommended Rasuvo 12.5 mg/0.25 ml sub cutaneous solution auto-injector (SC SOAJ) for the treatment of psoriasis and psoriatic arthritis.  The patient had been using methotrexate (MTX)intramuscular (IM) injection.  Arthritis in the hands made it difficult for her to use the vial and syringe necessitating a switch to an autoinjector.  Prior medication history included use of disease-modifying anti-rheumatic drugs (DMARD) sulfasalazine which caused intolerable diarrhea.  There were also reports of acid reflux, gastroesophageal reflux disease and abdominal pain which did not allow her to use oral DMARDs like methotrexate, leflunomide or cyclosporine.  The patient had been doing well on injectable methotrexate and was to continue the usage.

According to the current reviewed literature, Methotrexate is known to be safe and efficacious in the management of rheumatoid arthritis and psoriasis and thus has been used for the management of psoriatic arthritis despite a lack of evidence to support efficacy in psoriatic arthritis from randomized controlled trials.  The patient was recommended the medication for psoriasis and psoriatic arthritis and had utilized the intramuscular (IM) injection of methotrexate.  Prior medication history included use of DMARD sulfasalazine which caused intolerable diarrhea.  There were also reports of acid reflux, gastroesophageal reflux disease and abdominal pain which did not allow her to use oral disease modifying anti-rheumatic drugs (DMARD) like methotrexate, leflunomide or cyclosporine. 

The patient has improved with MTX. It is illogical to consider stopping it in this patient's situation. 

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

The insurer's denial of coverage for Rasuvo 12.5 mg/0.25 ml SC SOAJ is reversed. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Immunologic Disorders. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Descovy. 
The health plan's denial is overturned.

The patient is a male who has been on human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) with Truvada. Per records provided a request was made to change patient from Truvada to Descovy. He was reported to be experiencing side effects to Truvada, including nausea, vomiting, diarrhea, and night terrors. He was approved to change his PrEP to Descovy at that time.
Records indicate fairly regular follow-up sexually transmitted infection (STI) and HIV testing while on PrEP, as is required to be tested every 3 months. Descovy renewal was denied by the health plan based on not meeting criteria. The initial denial letter states patient's records do not show that patient has met criteria for medical necessity for Descovy are stated as: 1) demonstrated clinical intolerance to Truvada; 2) have documented other reason why you cannot take Truvada; 3) documented to be HIV negative within the last 3 months.
The letter states that the last HIV negative test was from a year ago.
Records reveal that the patient had a negative HIV viral load test (HIV-1 ribonucleic acid [RNA]) dated this month at the sexually transmitted disease (STD) clinic. This reviewer does find a 4th generation HIV test result; however, the negative viral load test should be sufficient evidence that patient remains HIV negative.
The subject under review is the medical necessity for Descovy.

The health plan's determination of medical necessity is overturned.

The requested Descovy is medically necessary for this patient. It is reasonable to require that for this patient to remain on PrEP it is imperative that he continue to be tested for HIV and sexually transmitted infections (STIS) every 3 months.  He does have a recent negative HIV-1 RNA test, which indicates that patient remains HIV negative. If this patient is sexually active with HIV positive (+) partners then this medication is medically necessary, not only to protect this patient's health, but to protect others with whom he might be sexually active. Based on his stated intolerance to Truvada, and the fact that he has been taking Descovy, it is reasonable and medically necessary to continue him on Descovy PrEP regimen.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cellulitis

Treatment: Inpatient hospital stay

The insurer denied coverage for inpatient hospital stay.

The denial is overturned.

This is the case of a male who presented to the hospital with an abscess of the right shoulder. The patient was initially seen at an outside clinic and was prescribed Keflex without improvement. The patient was afebrile. There was noted to be a very large abscess to the entire right shoulder with erythema, fluctuance, and a central eschar. Findings were consistent with cellulitis. White blood cell (WBC) count was 12.41. The patient underwent incision and drainage with debridement at bedside of a 12 x 12 cm (centimeters) abscess. Cultures were obtained. He was started on intravenous (IV) vancomycin and Unasyn. WBC decreased to 9.11. 

Inpatient hospital admission for skin and skin structure infections (SSSI) have continued to increase in the United States. However, hospital length of stay and mortality rate has decreased likely due to improvement in management. [1] SSSI patients with fever, larger lesions, and co-morbidities are more likely to require hospitalization. [2]

Per MCG (Milliman Care Guidelines) criteria, inpatient admission is medically necessary if there is failure of outpatient therapy with progression or no improvement after an adequate trial of antibiotics. [3] The patient had continued enlargement of the right shoulder abscess despite antibiotic therapy. 

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

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

Diagnosis: Hypertensive Emergency

Treatment: Inpatient hospital admission

The insurer denied coverage for inpatient hospital admission.

The denial is upheld.

This is a case of a male with a history of hypertension, chronic obstructive pulmonary disease, and trans-vascular repair of an aortic aneurysm, that presented to the hospital complaining of chest pain. Upon arrival, the patient was hypertensive with blood pressure (BP) 188/123 and pulse was 93. Physical examination was within normal limits. A 12-lead electrocardiogram (EKG) revealed no ischemic abnormalities. Serum blood testing revealed normal serial troponin levels (<0.01 ng/ml [nanograms per milliliter]). Computed tomography (CT) angiogram of the chest demonstrated a stent graft from the aortic arch to the middle of the descending aorta without a dissection. Following treatment with labetalol intravenous (IV) and then by mouth (PO) and BP was well controlled (161/98). The patient was discharged the following day.

Hypertensive emergency is defined as BP>180/120 with target organ damage. (1) In this patient, target organ damage was not noted. Although this patient had a previous history of trans vascular aortic repair, CT imaging revealed no abnormality. Moreover, the patient's blood pressure was rapidly controlled following treatment. This patient also complained of chest pain but had no EKG abnormalities and no elevation in serum troponin. Utilizing the HEART (History, EKG, Age, Risk factors, and troponin) score, he was considered low risk. (2) Utilizing the Thrombolysis in Myocardial Infarction (TIMI) risk score he also had a low risk of developing major adverse cardiac events in the subsequent 30 days. (3) Risk assessment of patients presenting with chest pain and no significant ST (interval on EKG) changes on EKG was reviewed by Hedayati, et al. (3) Using the HEART score risk stratification schema, this patient would have a low risk of major adverse cardiac events [defined as myocardial infarction (MI), need for percutaneous coronary intervention (PCI), need for coronary artery bypass grafting (CABG), or death] in the six weeks following presentation. In conclusion, acute inpatient admission was not medically necessary. 

The health care plan acted reasonably, with sound medical judgement, and in the best interest of the patient. 

The insurer's denial of coverage for the inpatient hospital admission is upheld. Medical necessity is not substantiated.