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

Diagnosis: rheumatoid arthritis (RA)
treatment: Simponi
The insurer denied Simponi. 
The health plan's determination is overturned.

The patient is a woman with rheumatoid arthritis (RA). Prior tx (treatment) included: Plaquenil, Cimzia, Prednisone, Enbrel, Humira and methotrexate (MTX). The issue in this case is subcutaneous (SQ) Simponi is being denied. The reason for the denial is SQ Simponi is a non-formulary medication and the per the health plan's policy, the member must have serious side effects or drug failure with all formulary medications (both brand and generic), including MTX, Imuran, SSz (Sulfasalazine), Plaquenil, Actemra, Enbrel, Humira, Xeljanz, Rinvoq, Orencia and Cimzia. The records reviewed state that the patient is of child bearing age and planning to conceive, which is why SQ Simponi is being prescribed as opposed to the formulary.

The formulary drugs would have potential adverse effects on the fetus as the patient is of child bearing age and plans on conceiving. These drugs are not approved to be taken when pregnant as there is a lack of data studying them. However, Anti-TNF (tumor necrosis factor) agents are approved for pregnancy and can be safely taken in the first two trimesters and may be considered in the third trimester as well on a case by case basis. The formulary drugs Actemra And Orencia would be effective in the treatment of RA but it's recommended they are stopped when pregnancy is confirmed. Likewise, Rinvoq and Xeljanz would be effective in the treatment of RA, but these drugs should be avoided in pregnant women.
The formulary medications are incompatible with pregnancy and should be avoided in a woman who is of child bearing age and plans on conceiving in the immediate future. For example, a study in in Drug Saf in 2016 concluded that 'the pregnancy outcomes reported in this small number of RA/psoriasis patients appear similar to those observed in the general population and in patients treated with biologic therapies for inflammatory diseases. However, definitive conclusions cannot be drawn, and pregnancy outcomes in patients receiving tofacitinib will continue to be monitored.' As stated in UpToDate, 'abatacept is not teratogenic in animals, but there are no adequate studies of its effects on human pregnancy to allow an assessment of its risk'.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Headache
Treatment: Inpatient admission
The insurer denied: Inpatient admission
The denial is upheld

The patient is an adult female. She presented to the emergency ward with the complaint of acute onset of headache seven days prior. The headache resolved, and she had subsequent difficulty producing speech, dropping items from her right arm and unsteady gait for three to four days.
The patient's neurological examination at presentation showed 4/5 right upper extremity strength and "mild" expressive aphasia. CT (computed tomography) of the brain was normal. She was admitted to the acute inpatient service for possible stroke.

The Inpatient admission was not medically necessary.
The patient has a one-week history of headache, and a four-day history of subtle neurological complaints and examination findings. Initial CT (computed tomography) imaging was negative. Her presentation did not support that she had an acute stroke, as her symptoms had been present for one week to four days. Her presentation did not support that she had a large stroke, as her examination findings were minimal. Her presentation did not support that she had any complications from possible stroke (Mendelson SJ, Prabhakaran, 2021) or that she was a candidate for acute intervention (Powers et al., 2018). The diagnostic studies, monitoring and treatment could have been safely and effectively provided at a lower level of care.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Asthma
Treatment: Alvesco (ciclesonide)
The health plan denied the treatment of Alvesco (ciclesonide) as non-formulary.
The denial is overturned.

The patient is a female with moderate persistent asthma, allergic rhinitis, and chronic sinusitis. She has been using a non-formulary drug, Alvesco, for control of her asthma. At issue is whether the formulary drugs, Annuity Ellipta, Flovent Diskus, Flovent Hydrofluoroalkane (HFA), Pulmicort Flexhaler, and Qvar Redihaler would cause adverse effects, or not be as effective as the non-formulary drug, Alvesco.

The health plan's determination is overturned in whole.

According to the documentation, the patient has tried multiple inhalers in the past for her asthma, including Flovent, Pulmicort, Advair, and Asmanex. The notes also state that she has had side effects with other inhalers, though these are not specified. The pharmacokinetics of ciclesonide are slightly different from other inhaled steroids because it is delivered to the airways as an inactive compound that is subsequently converted to the active metabolite. It also has a low oral bioavailability and a high clearance rate, potentially decreasing systemic side effects, though this has not been conclusively proven yet in large studies. In this patient who has had side effects from several other steroid inhalers, there is a reasonable chance that other formulary inhaled steroids will also cause side effects; therefore, she should continue using Alvesco, which has been working well for her and presumably has not caused the same side effects.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Blood Clot in the Leg
Treatment: Inpatient admission
The insurer denied: Inpatient admission
The denial is upheld

The patient in this case is an adult male with anti-phospholipid syndrome. He also was noted to have a history of prior venous thrombosis and was being treated with anticoagulation. He presented to the emergency department with right leg pain. Of note, he had been diagnosed with acute right lower extremity DVT (deep venous thrombosis) five days earlier and was treated with Lovenox at that time. He was not fully compliant with Lovenox and presented back to the emergency department with worsening right lower extremity pain. He was felt to not have treatment failure, but to have pain due to inadequate treatment related to non-compliance. Treatment with warfarin was recommended, and he refused that. He was treated with pain medication and discharged on Lovenox.

The inpatient admission was not medically necessary.
This patient presented with increased pain related to non-compliance with Lovenox. There was no documentation of acute limb ischemia or any other significant acute medical condition. The only treatments given were pain medication and instructions regarding adherence to necessary Lovenox treatment. He had no acute medical condition, no significant worsening of his right lower extremity DVT (deep venous thrombosis), and no active bleeding. Given these considerations, he did not require acute care inpatient admission.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Acute Kidney Injury (AKI). 
Treatment: Inpatient Admission. 

The insurer denied coverage for an inpatient admission.  The denial is upheld. 

This patient has a history of squamous cell carcinoma (SCC) and recently received cisplatin chemotherapy. He presented to the emergency room (ER) with complaints of weakness. The patient's chest X-ray (CXR) was within normal limits and temperature was 99.6 degrees F (Fahrenheit). The patient was given a 2.4-liter intravenous (IV) fluid bolus, Tylenol, Zofran, IV Vancomycin, and IV Cefepime. He was diagnosed with Acute Kidney Injury (AKI) likely in the setting of recent chemotherapy initiation. His IV fluids were continued, and creatinine remained stable. 

Acute Renal Failure is a known complication of cisplatin. He had an Estimated Glomerular Filtration Rate (eGFR) of 100 with creatinine 0.88. He was not neutropenic. The note says that he was well developed, well nourished, and in no acute distress, and reports a creatinine of 1.56. The creatinine level increased after admission. 

The inpatient admission is not considered medically necessary for this patient. While Acute Renal Failure supervened during the admission, it was not a problem on the day of admission. It is also possible that the administration of vancomycin, a nephrotoxic drug, in the emergency department (ED) could have contributed to the Acute Renal Failure. With the information presented, the inpatient admission was not medically necessary. 

"Vancomycin use is often associated with nephrotoxicity. It remains uncertain, however, to what extent vancomycin is directly responsible, as numerous potential risk factors for acute kidney injury frequently coexist. Herein, we critically examine available data in adult patients pertinent to this question. We review the pharmacokinetics/pharmacodynamics of vancomycin metabolism. Efficacy and safety data are discussed. The pathophysiology of vancomycin nephrotoxicity is considered. Risk factors for nephrotoxicity are enumerated, including the potential synergistic nephrotoxicity of vancomycin and piperacillin-tazobactam. Suggestions for clinical practice and future research are given." (Filippone et al., 2017). 

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

Diagnosis: Crohn's Disease
Treatment: Stelara
The insurer denied Stelara.
The denial is overturned.

The patient is a male with Crohn's disease and extensive family history of malignancy including non-melanoma skin cancer. He has attempted treatment with mesalamine and corticosteroids (including budesonide). He has required hospitalization for fistulizing Crohn's disease. Computed tomography enterography showed progressive fistulizing Crohn's disease, including ileal inflammation, ileocolic fistula, and a new perianal fistula. The coverage is requested for Stelara 90 milligrams (mg) for the treatment of Crohn's disease. The request was not approved because he has not attempted infliximab, adalimumab, or vedolizumab.

The health plan's determination is overturnred.

Stelara is supported over the use of Entyvio and anti-tumor necrosis factor medications for the treatment of Crohn's disease in this case. Stelara and Entyvio are recommended by American College of Gastroenterology guidelines for the treatment of Crohn's disease. [1] American Gastroenterological Association (AGA) guidelines for the treatment of Crohn's disease specifically do support the use of Entyvio in patients with Crohn's disease. [2] However, the guidelines recommend Stelara (and only suggest Entyvio) in Crohn's disease patients who are naive to biologic medications, stating "In adult outpatients with moderate to severe Crohn's disease who are naive to biologic drugs, the AGA recommends the use of infliximab, adalimumab, or ustekinumab over certolizumab pegol for the induction of remission and suggests the use of vedolizumab over certolizumab pegol for the induction of remission." [2] A recent study demonstrated that a significant majority of patients who have failed an anti-tumor necrosis factor medication achieve and maintain response with Stelara. [3] Stelara induces response more rapidly for the treatment of Crohn's disease than Entyvio. [4] Two studies showed that Stelara appears more effective than Entyvio in the treatment of Crohn's disease, with one finding odds ratio of remission of 2.01 and the other 2.58. [5,6] The patient has a family history of non-melanoma skin cancer, which is a risk factor for skin cancer; the use of anti-tumor necrosis factor medications such as infliximab and adalimumab can be associated with a higher risk of non-melanoma skin cancer. [7,8] For these reasons, the request is supported as medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obesity
Treatment: Saxenda
The insurer denied Saxenda.
The denial is overturned.

The patient is a female diagnosed with obesity. This request is for Saxenda. As reported; she has generalized anxiety disorder. She began taking a 15 milligrams (mg) dose of phentermine to address her metabolism and weight; but phentermine severely negatively impacted her mental health as her anxiety worsened. She struggled to fall asleep at night and noted feeling more low energy and feeling depressed. She lost only 2 pounds (lbs.) on phentermine. Her body mass index (BMI) was 32.87, weight was 82.8 kilograms (kg). The subject under review is the medical necessity for Saxenda.

The health plan's determination is overturned.

Saxenda is medically necessary. Saxenda is a glucagon like peptide 1 (GLP1) agonist that is used in the treatment of obesity[1-7]. The standard of care is to use the medication most compatible with the patient's condition and other medications. The standard of care requires that the patient be participating in lifestyle modification. It also requires that the patient has a BMI of 30 or greater or a BMI of 27 or greater with comorbidities such as hypertension, hyperlipidemia. The patient has an obese BMI and per medical records, the patient is participating in lifestyle modifications. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Obsessive-compulsive disorder (OCD) and generalized anxiety disorder (GAD). 
Treatment: Fluoxetine 60MG (milligrams). 

The insurer denied: Fluoxetine 60MG (milligrams). 
The denial is upheld. 

The case involves an adult female diagnosed with obsessive-compulsive disorder (OCD) and generalized anxiety disorder (GAD). The patient's physician has prescribed fluoxetine 60 milligrams and medical records indicate that the patient has been taking this medication at a dose of 40 milligrams for several years; the patient has shown a satisfactory clinical response with tolerability and is reported to be stable.  There are no reported symptoms of mania, formal thought disorder, psychosis, or severe cognitive impairment. Mental status findings include a cooperative female with normal speech and organized thought processing that his linear. Mood is okay. The patient has anxiety together with ruminations, obsessive anxiety, compulsive behaviors and excessive worry. The patient has general medical comorbidity with history of anemia, asthma, gastroesophageal reflux disease (GERD), and irritable bowel syndrome (IBS).
The health plan has denied coverage for the requested fluoxetine 60 milligrams (generic formulation for Sarafem) indicating that plan policy/guidelines for a coverage exception requires a trial and treatment failure with at least three formulary alternatives (step therapy) before a coverage exception would be considered. Preferred drugs and formulary alternatives include fluoxetine except the 60 milligrams tab, paroxetine, citalopram, escitalopram, Trintellix and Viibrid. 

The appeal is on the basis of submitted clinical information. 

The issue under review is a request for fluoxetine 60 milligrams (generic for Sarafem). 

The health plan should not cover the proposed treatment. 
In this case, the health plan formulary drug, fluoxetine other than the 60 milligrams formulation (generic for Sarafem), would be as effective as the requested non-formulary drug.  In addition, the formulary alternative with fluoxetine other than the 60 milligrams tab, would not be expected to pose any greater risk for adverse effects. Thus, the health plan's denial of coverage is reasonable and reflects sound medical judgment in keeping with the guidelines and scientific literature referenced below, as well as prevailing standards of medical practice and New York State instruction for this review. 

Standard practice would simply be to add a 20 milligram dose to the already prescribed 40 milligram dose in order to achieve the total daily dose of 60 milligrams. This strategy with two caps or tabs totaling 60 milligrams is standard practice.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Multiple Sclerosis.
Treatment: Vumerity 231/MG CPDR (delayed-release capsules). 
The insurer denied: Vumerity 231/MG CPDR (delayed-release capsules).
The denial is overturned.

The patient is an adult female with multiple sclerosis. Her provider wishes to start her on Vumerity. The request was denied coverage by the health plan, as the patient had not tried dimethyl fumarate or the other formulary alternatives. Her provider notes GI (gastrointestinal) intolerance to multiple medications.

The initiation of Vumerity is medically necessary.
It is noted in the appeal documentation that the patient has had GI (gastrointestinal) intolerance to various medication. Given the higher risk of GI (gastrointestinal) intolerance on dimethyl fumarate, it would not be an appropriate medication for the patient. Vumerity has been shown to be superior to Copaxone, and given the injectables and Aubagio tend to have similar efficacy levels, these would not be appropriate. Gilenya, while being a higher-efficacy medication, has more side effects and more monitoring requirements, which would not be appropriate for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic dermatitis.
Treatment: Dupixent 300MG (milligrams)/2mL (milliliter) Injection (Four per 14 Days).
The insurer denied:  Dupixent 300MG (milligrams)/2mL (milliliter) Injection (Four per 14 Days).
The denial is upheld.

The patient is an adult male with atopic dermatitis, treated with topical steroids, topical antibiotics and prednisone. The provider is requesting Dupixent.  The patient has 30% body surface area (BSA).  The health plan requires a trial and failure to both topical steroids and a topical calcineurin inhibitor.

The proposed treatment with Dupixent is not medically necessary.
The health plan denied the request with requirement of a trial and failure to both topical steroids and a topical calcineurin inhibitor.

Standard of care measures for atopic dermatitis include topical calcineurin inhibitors and phototherapy, as well as systemic immunosuppressants.  According to the recommendations provided by Simpson et al (2017), steps taken before commencing systemic therapy include considering alternate or concomitant diagnoses, avoiding trigger factors, optimizing topical therapy, ensuring adequate patient/caregiver education, treating coexistent infection, assessing the impact on quality of life, and considering phototherapy.  

This patient has not demonstrated an adequate trial and failure to all other standard of care measures for atopic dermatitis. Therefore, Dupixent is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: enterocutaneous fistula
treatment: inpatient stay
The insurer denied the inpatient stay. The health plan's determination is upheld. 

The patient is a woman who presented to the emergency department (ED) with complaints of abdominal pain and diarrhea. At the time of presentation, the patient was without fever and the heart rate was elevated at 102/minute. She had been discharged from another health care facility earlier, but was too weak at home and was brought in by Emergency Medical Services (EMS). 

An inpatient level of care was not medically necessary in this case. This patient is a woman with a known enterocutaneous fistula related to prior surgery. Although this patient had significant comorbid health issues, she was clinically stable at the time of ED presentation and remained stable throughout the period of monitoring under consideration. She was able to tolerate a diet and her pain level had improved. There is no documentation of hemodynamic, pulmonary, neurological, or metabolic reason for an acute inpatient level of care. A lower level of care would have provided for ED assessment, surgical consultation, and monitoring, provision of intravenous (IV) fluid, and overnight care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Juvenile Idiopathic Arthritis. 
Treatment: Humira 40mg. 
The insurer denied the Humira 40mg. 
The denial is overturned. 

This case involves a male patient with juvenile idiopathic arthritis, likely enthesitis related arthritis versus psoriatic arthritis.  He is being treated by a board certified pediatric rheumatologist.  He has tried and failed naproxen therapy.  His provider is asking to start Humira (adalimumab) to treat his juvenile idiopathic arthritis (JIA).  His health plan denied the request because the patient has not tried and failed a non-biologic disease modifying anti-rheumatic drug (DMARD) such as methotrexate first.  The patient's provider is appealing this denial. 

Yes, the proposed treatment with Humira is medically necessary. 

The request for Humira was denied as current plan approved criteria only allow coverage of Humira if there is documentation to support that any of the following is met: a) the patient has received a biologic or targeted synthetic disease modifying anti-rheumatic drug (DMARD) for juvenile idiopathic arthritis (JIA), b) the patient has tried methotrexate or a non-biologic disease modifying anti-rheumatic drug and it did not work, or c) the patient has risk factors (positive rheumatoid factor / cyclic citrullinated peptide, pre-existing joint damage).  This patient did not meet those criteria. 

However, this patient has juvenile idiopathic arthritis, likely enthesitis related arthritis.  He has a documented magnetic resonance image (MRI) of the pelvis showing concern for sacroiliitis.  The American College of Rheumatology Treatment Guidelines state that treatment with a tumor necrosis factor (TNF) inhibitor is recommended for juvenile idiopathic arthritis patients with sacroiliitis.  Additionally, there are multiple articles that demonstrate the safety and effectiveness of Humira for juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA). 

No, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient in this case. 

The health plan reviewed this case based on the assumption that this patient has polyarticular juvenile idiopathic arthritis, where non-biologic disease modifying anti-rheumatic drugs (DMARDs) can be effective.  The provider clearly states the patient has juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA) and sacroiliitis. Humira should be approved for this patient for a duration of 12 (twelve) months.