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

Diagnosis: Atopic dermatitis

Treatment: Dupixent 300 mg/2mL SC SOSY

The insurer denied the medication Dupixent 300 mg/2mL SC SOSY.

The denial was reversed.   

This is an adolescent male patient diagnosed with atopic dermatitis. He has 70 percent body surface area (BSA) affected and requesting Dupixent (generic name dupilumab). He has failed multiple topical agents and methotrexate.  A recent expert review noted that "Dupilumab has shown strong efficacy and safety for treatment of moderate-to-severe AD in adults. 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 in adults with moderate-to-severe AD who are uncontrolled with topical therapies."  With regard to dupilumab in children/adolescents they noted that a study in "pediatric patients (age 6 to <18 years) was recently completed; however, results are not yet available. Recommendations for the use of dupilumab in pediatric patients will depend on the safety and efficacy results in this population in phase 3 studies."  Subsequent to that review, the results of the study were published and the authors concluded "In this study, dupilumab significantly improved AD signs, symptoms, and quality of life in adolescents with moderate to severe AD, with an acceptable safety profile."

According to Up to Date, "For children older than six years with refractory AD for whom phototherapy is not accessible or impractical, we suggest dupilumab therapy rather than other immunosuppressive therapy."  Of note, with regard to cyclosporine, they state "For children and adolescents with refractory AD for whom phototherapy or dupilumab are inaccessible, undesirable, or ineffective, cyclosporine is our first-choice immunosuppressive agent."  

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.  Dupixent 300 mg/2mL SC SOSY is t considered medically necessary for this patient.

The carrier's denial of coverage for Dupixent 300 mg/2mL SC SOSY is reversed.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Type 2 Diabetes Mellitus
Treatment: External transmitter for a continuous glucose monitor (CGM)
The insurer denied the external transmitter for a continuous glucose monitor (CGM).
The denial was overturned.   

This is a male patient with history of uncontrolled Type 2 Diabetes Mellitus treated with Basal and Bolus insulin, Basaglar and Admelog regimen; with blood sugars fluctuating from hypoglycemia of 40 mg/dL up to hyperglycemia 315 mg/dL.  The patient's endocrinologist documented that the patient is doing 1 HGM 3-4 times daily, and had ordered Free Style Libre 14 reader and sensor for the patient.  

Based on data published in Annals of Internal Medicine, Beck et al (2017), the DIAMOND study found that the use of continuous glucose monitor (CGM) in Type 2 Diabetes on insulin, improves glycemic control without increasing risk of hypoglycemia. Arguello et al (2017) also indicated that the use of CGM lowers risk of hypoglycemia.  

The patient has had multiple episodes of symptomatic hypoglycemia on his insulin regimen, and had been difficult to control. As per the patient's recent fasting C-peptide level, the patient's provider indicated that this patient had very little insulin production and his condition has progressed to similarly mimic the clinical presentation of type 1 diabetes. Due to this patient's fluctuating blood sugars, ranging from high to low, this patient's hemoglobin A1c may be in good range and misleading in assessing this patient's diabetic control. Literature review supports that continuous glucose monitor (CGM) would be beneficial for this patient's diabetes management. Thus, CGM is considered medically necessary for this patient.

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

The carrier's denial of coverage for external transmitter for a continuous glucose monitor (CGM) should be overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis
Treatment: Dupixent
The insurer denied the Dupixent.
The denial is overturned. 

The patient is a woman with atopic dermatitis for whom Dupixent is requested. She has severe atopic dermatitis affecting greater than (>) 50% body surface area (BSA), and including sensitive areas. She has tried and failed multiple topical steroids in the past.

Yes, the treatment with Dupixent is medically necessary.

The patient has severe atopic dermatitis affecting multiple and sensitive areas of the body and a BSA affected over 50%. She is a candidate for systemic therapy, as the BSA is too large for reasonable control with topical medications. Topical steroids or calcineurin inhibitors are not appropriate therapy for severe, widespread atopic dermatitis, affecting sensitive areas, which should be treated with systemic therapy. 

Dupilumab is a monoclonal antibody that inhibits IL-4 and IL-13 signaling by blocking the shared IL-4Ra and originally demonstrated efficacy in phase 2 clinical trials. In March 2017, it was approved by the US Food and Drug Administration (FDA) for adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It is a subcutaneous injection administered initially at a dose of 600 mg and then every two weeks thereafter.

Approval of dupilumab was based on clinical trials investigating dupilumab as monotherapy (SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS). Results from the SOLO 1 (n=671) and SOLO 2 (n=708) trials showed 36-38% of patients who received dupilumab had scores of 0 or 1 (clear or almost clear) on the Investigator's Global Assessment scale compared with placebo (8-10%) (P< .001). Additionally, improvement from baseline to week 16 of at least 75% on the Eczema Area and Severity Index (EASI) was reported in significantly more patients who received each regimen of dupilumab than in patients who received placebo (P < .001).

Given its unprecedented efficacy, dupilumab is emerging as a first-line therapeutic for moderate-to-severe Atopic Dermatitis (AD). The patient has failed topical steroids, calcineurin inhibitors, and systemic steroids. Additionally, topical calcineurin inhibitors are not indicated for severe disease. Therefore, the treatment with Dupixent is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Osteomyelitis

Treatment: Skilled Nursing Facility admission

The insurer denied coverage for Skilled Nursing Facility admission.

The denial is overturned.

This is male patient has a medical history of coronary artery disease, chronic systolic heart failure, chronic kidney disease (stage 3), diabetes mellitus (on insulin), hypertension, peripheral vascular disease, myocardial infarction (status post stent), toe amputation, thymectomy, myasthenia gravis, Guillian Barre syndrome and chronic right foot wound.  He was admitted to the hospital and per podiatry notes he has a history of right foot partial 1st ray amputation and was seen for right foot wound/ulcer and osteomyelitis of the right heel. He underwent right heel spur resection. The surgical pathology report was negative for inflation of the right calcaneal bone. The wound culture was positive for Klebsiella oxytoca, Corynebacterium Pseudodiptheriticum, and Stapylococcus epidermis. He was treated with intravenous (IV) antibiotics. Per physician progress notes, the plan was for the patient to be discharged with oral antibiotics for 2 weeks. He is also restricted from weight-bearing on the right lower limb for 6 weeks. It had been deemed in the best interest of the patient by both skilled therapy and physician that the client be discharged to a skilled nursing facility (SNF) for further therapy and medical management of wound infection.

The physical therapy (PT) progress notes recommend continued physical therapy in SNF 3-5 times per week due to functional mobility impairment (right lower limb non-weight bearing restriction, inability to negotiate stairs, inability to walk). Activities of daily living (ADL) mobility training indicated that he requires maximum assistance for transfers, bed to commode, and sit to stand. Cited environmental barriers at home include stairs and bathroom on second floor. Documentation indicates that he is non-weight bearing on the right lower limb for 6 weeks and requires wound VAC therapy.

Skilled nursing facility (SNF) admission is considered medically necessary for this patient. The patient has both complex medical, nursing care, and rehabilitation service needs. The need for oral antibiotic therapy for treatment of the multi-organism wound infection in this immunocompromised (secondary to type II diabetes) individual is a complex medical need. He requires close medical monitoring of response to treatment. He requires optimization of treatment of insulin dependent type II diabetes to facilitate wound healing. He is high risk for developing wound contamination without daily skilled nursing for wound inspection and care. He needs skilled PT to maximize functional independence for balance, transfers, stair use, and ambulation while maintaining the non-weight bearing restriction on the right lower limb. 

The carrier's denial of coverage for skilled nursing facility (SNF) admission is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Digestive System/Gastrointestinal
Inpatient hospital

Diagnosis: abdominal pain
Treatment: Inpatient stay
The insurer denied the inpatient stay. The health plan's determination is overturned. 

The patient is a female admitted to the hospital. The patient has a remote history of (H/O) a cholecystectomy. The patient was admitted with 1 day of abdominal and back pain associated with nausea and vomiting. No associated fever or chills were noted. The patient underwent an ultrasound which demonstrated a dilated common bile duct (CBD) with a CBD stone. Labs showed no elevated white blood cell count (WBC) but there was a bump in her liver function test (LFT). Lipase was normal. The patient underwent an endoscopic retrograde cholangiopancreatography (ERCP). 

The inpatient stay is medically necessary. The patient had a very symptomatic CBD stone which required an invasive procedure for resolution. The patient presented with recurrent vomiting and was not able to take by mouth (PO). Therefore, the procedure could not be scheduled electively after discharge from the emergency room. Moreover, a day is needed after the procedure to observe the patient and assure that symptoms are resolving and there were no complications. This case could not have been handled safely any other way than by an inpatient hospital stay.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: Parosteal osteosarcoma
Inpatient Hospital Stay
The insurer denied the Inpatient Hospital Stay
The determination is overturned in part.

This is a patient with a history of a left femur parosteal osteosarcoma who previously underwent prior wide resection of this tumor and distal femoral replacement. The patient developed painful patello-femoral arthritis that required patello-femoral arthroplasty and revision of some of the distal femoral replacement components. The surgery was successful and there were no documented complications from the surgery or the hospital stay. The patient was admitted after surgery and was subsequently discharged home. At issue in this case is the medical necessity of the inpatient hospital stay.
The inpatient hospital stay was medically necessary in part for the patient to receive postoperative antibiotics and pain medication. The records also document that a drain was in place and its output was sufficiently diminished to allow removal. Lastly, the patient did require post-operative physical therapy following the operation. Appropriate progress with post-operative physical therapy was documented to safely allow discharge of this patient to home. At that time, further inpatient stay was not medically necessary for this patient. The rationale for this determination is based upon the provided medical records. The progress note for this patient documented that the patient had her pain well controlled and she participated in supervised physical therapy. The note also documented the the patient was voiding freely and tolerating a regular diet. In addition, the drain output was documented as only 5/10 cubic centimeter (ccs) in the past 24 hours. Physical therapy documented that the patient ascended 10 stairs, performed a safe bathroom transfer, and was able to complete gait training with axillary crutches and no pain. Based upon this documentation, the patient was stable for discharge to home.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental Disorder 
Treatment: Tooth colored cap (crown) for tooth #30 

The insurer denied the Tooth colored cap (crown) for tooth #30. The determination is overturned. 

The patient presented for evaluation and treatment of tooth number (#) 30. Provided for review are previous letters of appeal and denial, full mouth radiographic images, one page of American Dental Association (ADA) claim forms, health history forms, and clinical notes. Previous denials have been on the basis that the patient must have fewer than eight posterior teeth that are in occlusion or eight posterior teeth that are false teeth in order for a crown to be a covered benefit and that the patient does have eight or more posterior teeth in occlusion. At issue is the medical necessity of the planned treatment of a tooth colored cap (crown) for tooth #30. 

Yes, the service/treatment of tooth colored cap/crown for tooth #30 is medically necessary. There has never been any published data that contends that teeth should not be restored if there are eight teeth in the posterior of the mouth that are in occlusion. Based on the radiographic evidence and the notes, tooth #30 has suffered a loss of tooth structure over time and involving the cusps of the tooth, with evidence of a developing fracture. As such, the appropriate treatment is to protect the tooth from further fracture and loss and restore the cusps in order to maintain the tooth in function and retain the tooth in general. Hence, the treatment of the requested tooth colored cap (crown), crown for tooth #30 is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Central Nervous System/Neuromuscular disorder, other 
Treatment: Home Heath Care  

The insurer denied Personal Care Assistance, Level II, 40 hours per week over a period of 7 days. The denial is overturned. 

The patient with past medical history of benign prostatic hyperplasia (BPH), chronic pain, chronic lightheadedness and imbalance, hypertension, gastroesophageal reflux disease (GERD), unsteady gait with history of falls and depression who had been assigned Personal Care Aid (PCA) services hours 4 hours/day, 3 days/week to total 12 hours/week based on assessment tool. 

Yes, the requested health service treatment of Personal care Assistance, 40 hours per week is medically necessary for this patient. The patient had previous help 7 days per week when his spouse was alive (due to her PCA service hours). The patient needs assistance with tasks of meal preparation, ordinary housework, stairs, shopping and transportation and his PCP indicated the patient would benefit from more help with walking, locomotion and managing medication. The patient also had a fall with resultant decline in health. 

The request for increase in PCA hours was not solely for safety and companionship but to assist the patient with Instrumental Activities of Daily Living IADL's and ADL's to remain independent in the home.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Diabetes
Treatment: Formulary exception for Invokana
The insurer denied the Formulary exception for Invokana.
The denial is upheld.

The patient is a male. He has tried and failed metformin, Actos, and Farxiga. He has been on Invokana. The request for Invokana is under review. 

No, the health plan should not cover the Formulary exception for Invokana.

This patient has not tried and failed Jardiance. Jardiance is expected to be at least as equally safe and effective as Invokana for the treatment of type 2 diabetes. The American Diabetes Association clinical guidelines do not recommend the use of Invokana over the use of Jardiance for the treatment of type 2 diabetes. Therefore, no, the health plan should not cover the proposed Invokana.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Type 1 Diabetes Mellitus.
Treatment: Humalog Kwikpen.
The insurer denied the Humalog Kwikpen.
The determination is upheld.

The patient was diagnosed with type 1 diabetes mellitus (T1DM) with hyperglycemia. This request is for Humalog. As reported, he is on very high doses of insulin; he needs the concentrated form for absorption reasons. He is not at goal taking Novolog. He is on a Tandem T-slim Pump and Dexcom continuous glucose monitor (CGM). He is on Trulicity 1.45 milligrams (mg) weekly and Novolog. He is not using Control IQ technology. His A1C was 6.8 %.
The note from 5/11/20 indicates that he was on NovoLog. The hemoglobin A1c at this time was 6.8%. He was switched to U200 Humalog so that he can take advantage of control IQ. His body mass index (BMI) is 37.9. The note reports that he is taking more than 100 units per day. At issue is whether the formulary drug will be or has been ineffective, would not be as effective, or would have adverse effects.
This is a patient with type 1 diabetes mellitus (T1DM) with hyperglycemia. There are no studies demonstrating superiority of one rapid acting insulin analog over another(1-4). The patient is on an insulin pump. The Food and Drug Administration (FDA) label for Humalog U-200 explicitly prohibits use of this insulin in an insulin pump. The formulary alternatives Fiasp and NovoLog have not been ineffective and would not be expected to be ineffective or have worse adverse side effects than the requested medication.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Vision/glaucoma
Treatment: Pharmacy/prescription drugs
Issue: Formulary exception
The health plan's determination is upheld in whole. The formulary drug dorzolamide-timolol (the generic form of Cosopt) would be considered as effective as the non-formulary drug Cosopt PF. 

The patient has a history of pseudoexfoliation glaucoma.  Patient has been on multiple medications as well as having surgery for lowering IOP. The formulary drug dorzolamide-timolol (the generic form of Cosopt) would be considered as effective as Cosopt PF. Cosopt PF is a combination of dorzolamide and timolol. The advantage is that it is preservative free but there is no indication as to why the patient is requiring a preservative free medication. The intraocular pressure was 9 on last exam which would be considered an excellent result or control of IOP for glaucoma.
The patient was on latanoprost in the past but was switched to Lumigan and then to Zioptan for IOP control.  The patient was switched from Combigan to Cosopt PF for IOP control. It is not clear from the physician progress notes submitted for review whether Travatan Z was ever used by the patient.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Type 2 Diabetes without complications 
Treatment: Formulary exception for Kombiglyze XR (saxagliptin-metformin ER) 

The insurer denied the Formulary exception for Kombiglyze XR (saxagliptin-metformin ER). The denial is overturned. 

Yes, the health plan should cover the formulary exception for Kombiglyze XR. 

This is a female with type II diabetes. She has been successful with Kombiglyze in the past. She has tried and failed Jentadueto XR due to severe reflux. She has tried and failed Farxiga due to fatigue. 

This patient has tried and failed Jentadueto XR due to severe reflux. It is not appropriate to try Jentadueto in this clinical situation in this patient who was intolerant to Jentadueto XR. This patient has been successfully treated with Kombiglyze XR, and the use of Kombiglyze XR in this clinical situation is supported by the Kombiglyze XR prescribing information and the American Diabetes Association clinical guidelines. Therefore, yes, the health plan should cover the proposed treatment.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Anterior crossbite. 
Treatment: Braces. 
The insurer denied the braces and associated monthly visits. The health plan's determination is overturned. 

The patient in question is a female with an anterior crossbite on teeth 7 and 10. She presents with a skeletal Class I malocclusion with minor crowding in the maxilla and minor crowding in the mandible. She is treatment planned for 18-24 months of orthodontics to address the crowding and crossbite, but the treatment was denied due to lack of medical necessity. 

The braces and associated monthly visits are medically necessary for this patient. 
This patient presents with an anterior crossbite as well as severe crowding. Side effects of an untreated anterior crossbite include abnormal wear to the affected teeth and labial displacement of the mandibular incisors that can lead to periodontal defects. 
If left untreated, the damage that will likely occur to the patient's teeth will be much more time consuming and difficult to correct than the patient's existing orthodontic problem. For this reason, the requested treatment is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Sleep apnea
Treatment: Continuous POS Airway Pressure Device
(E0601- CPAP) 
The insurer denied the Continuous POS Airway Pressure Device
(E0601- CPAP).
The denial is upheld. 

The patient is a female with a diagnosis of obstructive sleep apnea.  She has been prescribed continuous positive airway pressure (CPAP) and is noncompliant with the treatment.  The request is for authorization for continued use.

No, the proposed continuous POS Airway Pressure Device (E0601) is not medically necessary.

According to the guidelines provided by the health care plan, these guidelines are compatible with the guidelines published by the American Academy of Sleep Medicine.  In order to get optimum health benefit from the treatment of obstructive sleep apnea with the CPAP, the literature and guidelines provided suggest that the person must use a CPAP for more than 70% of the nights for more than four hours.  

In the case under review, the compliance data provided that the patient used the CPAP for more than four hours only on 31.6% of the nights; and out of the 114 nights only 48 days were on the CPAP, 66 days were without the CPAP.  Therefore, the device use is 42.1% out of which 31.6% is used for more than four hours.  The patient's average days used is two hours 12 minutes.  There has been no documentation provided with the patient had face-to-face evaluation after going on the CPAP with the treating physician discussing the response to therapy or problems with the therapy.  Therefore, the patient has failed the compliance and adherence and hence failed the CPAP treatment due to compliance and adherence issues.  Therefore, the patient does not meet the medical necessity guidelines for continuation of therapy.  The guidelines also state that for the first 90 days, the patient should use a CPAP for more than 70% of the nights for more than four hours, after that should have a face-to-face evaluation by the treating physician discussing the response to the therapy.  No such documentation was provided.