Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Pyoderma gangrenosum and pemphigus
Treatment: Intravenous Immune Globulin (J1561)
The insurer denied the Intravenous Immune Globulin (J1561).
The denial is overturned.

This patient is an adult male with history of pyoderma gangrenosum (PG) and pemphigus vulgaris. Due to the patient's disease, he has already had a leg amputation. The
patient has previously tried and failed prednisone and cyclosporine. The patient was started on intravenous immune globulin (IVIG) last year and responded well to therapy. He has not developed any new lesions since treatment with IVIG. The request for IVIG was initially denied due to being investigational in the treatment of PG.

The health plan should cover the proposed treatment.

The requested health service or treatment is more beneficial than any standard treatment for the insured's condition or disease. The request for IVIG was initially denied due to the use of IVIG for the treatment of PG not being supported by DrugDex as recommendation level IIa or higher or literature not showing at least one published article with a sufficient number of subjects showing that the use of the drug is generally safe and effective.

Documentation does support a diagnosis of severe PG. There is no proper documentation supporting pemphigus. The patient's PG is severe and the patient has had a below the knee amputation due to severity of disease. IVIG and the alkylating agents of cyclophosphamide and chlorambucil are options for patients with severe PG that is refractory to first- and second-line agents. The patient has tried and failed cyclosporine which is first line therapy. Documentation does not indicate that the patient has tried and failed second line therapy such as biologics such as tumor necrosis factor inhibitors, however, these can be higher risk for infection in a patient who is already at high risk of infection due to underlying diabetes. IVIG is typically given in divided doses over the course of two to five days, repeated monthly. Efficacy data for IVIG for PG is limited. A systematic review of cases and case series documenting treatment of refractory PG with IVIG (often in conjunction with systemic glucocorticoids) found complete responses in 26 of 49 patients (53 percent) and complete or partial responses in 43 of 49 patients (88 percent). The mean time to initial response was 3.5 weeks, and patients were treated for an average of 5.9 months. This patient has already been started on IVIG and has responded well and therefore it would be in the patient's best interest to continue on IVIG at this time. Therefore, the requested health service or treatment is more beneficial than any standard treatment for the patient's condition or disease.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Pyoderma gangrenosum and pemphigus
Treatment: Intravenous Immune Globulin (J1561)
The insurer denied the Intravenous Immune Globulin (J1561).
The denial is overturned.

The patient is an adult male diagnosed with pyoderma gangrenosum (PG) and bullous pemphigoid (BP), with multiple co-morbidities including diabetes, hypertension and gout. He has tried and failed cyclosporine, prednisone and antibiotic therapy; he underwent amputation due to severe disease. The patient had a positive response to intravenous immune globulin (IVIG) in the past which controlled the disease but is now experiencing a flare. The treating provider is requesting treatment with IVIG but the health plan denied the request, so the provider is appealing the denial. The provider feels that treatment is essential to reduce risk of another amputation. 

The health plan should cover the proposed treatment.

The patient has severe disease and has experienced serious complications including amputation. The patient has had successful results with IVIG in the past and requires continued care to control disease activity.

Per Li, N, et al (2018), "IVIG is an effective therapy for BP through multiple mechanisms."
Hoffman, JHO, et al (2019), writes "The immunomodulatory potential and low incidence of severe side effects of high-dose IVIG treatment led to its successful application in a variety of dermatological autoimmune diseases over the last two decades. IVIG is usually administered at a dose of 2 grams per kilogram body weight distributed over 2-5 days every 4 weeks. They are most commonly used as a second- or third-line treatment in dermatological autoimmune disease (pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, epidermolysis bullosa acquisita, dermatomyositis, systemic vasculitis, and systemic lupus erythematosus). However, first-line treatment may be warranted in special circumstances like concomitant malignancy, a foudroyant clinical course, and contraindications against alternative treatments."

The requested health service or treatment is more beneficial than any standard treatment for the insured's condition or disease. The use of IVIG was denied because the health plan does not allow treatment with IVIG for the patient's condition. However, the patient has severe disease and has benefitted from IVIG in the past. Due to complications, the patient underwent amputation. Because the patient has had previous complications, being required to try multiple medications places the patient at risk for future limb amputations. Current medical literature shows that use of IVIG is beneficial in treating the patient's disease activity. It is medically more beneficial to use a medication that has demonstrated positive results with than to experiment with other medications that may or may not work. Strong traditional medications have not been successful in treating the patient's conditions.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental issues
treatment: Implant placement tooth 20
The insurer denied implant placement tooth 20. The health plan's determination is overturned.

The patient is a male who presents for the treatment of tooth #20. 

Implant Placement, Tooth 20 is medically necessary for this patient.
Based on the provide documentation, the patient was missing tooth #20, creating the diagnosis of diminished posterior support as well as partial edentulism. With the diagnosis of partial edentulism as well as diminished posterior support the only therapy capable of addressing both diagnosis is that of implant therapy as it is anchored within the bone offering complete support stability and retention for a tooth prosthesis. Fixed partial dentures do not offer additional support and actually depend on the residual dentition to replace the missing tooth simply putting additional load on the residual teeth without replacing the loss. Removable partial dentures are tissue supported prosthesis and do not offer any support to the dentition as they are designed to become passive upon load. After the implants have integrated, they will require restorations in the form of abutments and crowns in order to complete the tooth replacement. This is standard in tooth replacement involving implants. Hence the Implant Placement, Tooth 20 is medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Shortness of breath. 
Treatment: Inpatient admission. 

The insurer denied coverage for inpatient admission.  

The denial is upheld.  

Patient is an adult male with a history of asthma, polysubstance abuse, right upper lobe (RUL) cavitary lesion, anxiety and depression.  The patient presented to emergency department (ED) with complaints of shortness of breath (SOB). He was treated with intravenous (IV) steroids and bronchodilators. 

At presentation his vital signs were within normal limits and his oxygen saturation was 94% on room air.  Lung exam revealed rhonchi.  The patient was alert and oriented to person, place and time with a non-focal neurological exam. White blood cells were 7.1, Hemoglobin 14.2, Venous blood gas 7.37/52/29 and arterial blood gas 7.37/46/168/26, Pulse oximetry on room air was 99 percent.  His Clinical Institute Withdrawal Assessment for Alcohol (CIWA) was zero at admission. 

The patient received Duo Nebulizers and steroids. Due to respiratory distress, he was placed on bi-level positive airway pressure (BIPAP). Oral (PO) Doxycycline was initiated.  Electrocardiogram had no acute ST-T (segment) changes.  Chest X-ray was negative for infiltrates, effusions or pneumonia. He rapidly improved after treatment in the emergency department (ED). 

By the next day his vital signs remained stable, peak expiratory flow was 180 and some rhonchi were heard on lung exam. He was discharged home on oral steroids, antibiotics and bronchodilators. 

This patient did not need acute inpatient hospitalization. He could have been placed in Observation status while diagnostic testing and treatment were initiated.  Observation could be for up to 48 hours. The patient improved rapidly after being placed on BIPAP and treatment in the emergency department (ED) with steroids, bronchodilators, magnesium and antibiotics. 

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 is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Skin Disorders/Psoriasis
Treatment: Pharmacy/Prescription Drugs/Sotyktu
The health plan denied the requested medication, Sotyktu, as not medically necessary. The health plan's determination is upheld.

The patient is a male with moderate to severe plaque psoriasis affecting the scalp who has failed previous therapy with topical and intralesional corticosteroids, Humira, Tremfya, and Cosentyx. Request for coverage of Sotyktu.
At issue is the medical necessity for the requested medication, Sotyktu.

I recommend to uphold, in whole, the health plan's determination of medical necessity.

The requested health service/treatment of Sotyktu is not considered medically necessary for this patient.
The patient has not had a trial of other available preferred plan alternative formularies (Enbrel, Otezla, Stelara, Skyrizi, Infliximab), nor has a contraindication to these other preferred plans alternative formularies. The other available preferred plan alternative formularies are Food and Drug Administration (FDA) approved for moderate-severe plaque psoriasis and have shown good efficacy with acceptable safety profiles when used to treat plaque psoriasis.
Review of phase III clinical trial data shows Sotyktu achieving a psoriasis area severity index (PASI) 75 in psoriasis patients of 58.4% after 16 weeks of therapy. This is inferior to the PASI 75 rates seen in phase III clinical trials with Stelara, Skyrizi, and Infliximab, which show rates of 79%, 91%, and 81% respectively at their primary endpoints. The patient does not have a clinical reason to not use Stelara, Skyrizi, or Infliximab as well. Therefore, Sotyktu has inferior efficacy compared to several treatments that are available for the patient to use instead. For the above reasons, the use of Sotyktu is not considered medically appropriate or necessary at this time.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Body mass index greater than 30.
Treatment: Wegovy.
The insurer denied: Wegovy.
The denial is overturned.

This adult female is appealing denial of Wegovy. Per clinical note from last month, the patient's body mass index is 36.84. The patient has tried and failed six months of lifestyle changes with diet and exercise. Benzphetamine was started. A phone encounter reports adverse effects to Benzphentamine. Phentermine was started. A phone encounter recently reports adverse effects to phentermine.

The health plan should cover the proposed treatment.

Wegovy is Food and Drug Administration (FDA) approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 or greater or body mass index of 27 in the presence of at least one weight-related comorbid condition. This patient has a body mass index greater than 30. She is involved in lifestyle modification. She has tried and failed two of three formulary alternatives. Wegovy is medically necessary because it is consistent with generally accepted medical standards for this patient. The health plan should cover the proposed treatment.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Diabetes Mellitus
Treatment: Novolog FlexPen
The insurer denied Novolog FlexPen.
The determination is upheld.

This is a female patient with diabetes mellitus. The request is for Novolog. As reported, the patient has an allergy to insulin Lispro. She has tried several formulation/brands of insulin Lispro and has developed a rash. This has led her to seek emergent services in the past. She has been able to tolerate Novolog. As per a visit note, she presented to the emergency room (ER) with increased thirst, weakness and polyuria, her hemoglobin A1C was 13.5 percent (%). She is on Novolog and Tresiba; Dexcom G6.
Her glutamic acid decarboxylase (GAD) was greater than (>) 250; islet antigen 2 (IA-2) antibody was less than (<) 5.4; islet cell antibody was positive; zinc transporter 8 (ZnT8) was 17; C-peptide was 0.7. Her A1C  was 7.9 % and 13.5 %. At issue is the medical necessity of Novolog FlexPen.

The requested Novolog FlexPen is not medically necessasary.
There are no studies demonstrating superiority of one rapid acting insulin analog over another [1-7]. There is no evidence of a contraindication or previous trial or adverse reaction to the formulary alternative Insulin Aspart which is bioidentical to NovoLog. Based on this, the requested Novolog is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Asthma.
Treatment: Inpatient admission.
The insurer denied coverage for inpatient admission.
The denial is upheld.

 
This patient is a child with respiratory symptoms of cough and fast breathing that presented to the emergency department (ED); the patient was noted to be in no distress. In the ED physician note, it was documented "no distress", no tachypnea, and mild wheeze. The oxygen saturation was > (greater than) 90 % (percent).  No hemodynamic instability. Perfusion was adequate. No labs or chest x-ray was done. The patient was treated with nebulization and steroids. The clinical status improved. The patient was discharged with scheduled nebulization and steroids and close pediatric follow up.

There was no persistent hypoxia and no need for continuous positive airway pressure (CPAP) or high flow nasal canula (HFNC). Only minimal need for nasal canula oxygen. There was no need for pressors or multiple boluses. No labs or arterial blood gas (ABG) was done in the ED as the ED doctor did not deem the clinical status was serious enough to give intravenous (IV) steroids in the ED. The patient was only given Decadron by mouth (PO) in the ED.  Also, there was no severe dehydration on clinical exam. The general exam was documented as "no acute distress", respiratory exam was documented as wheezing. Even though magnesium sulfate was given, no second line treatment such as continuous albuterol or epinephrine or terbutaline was administered. If one were to take the Pediatric Respiratory Assessment Measure (PRAM) score to assess the pediatric asthma, it would be in the category of mild asthma. If one were to take the Pediatric Early Warning Score (PEWS), it would have been desirable also indicating an expectant and stable course in hospital. The patient did not have severe persistent asthma and only had mild intermittent asthma as per underlying asthma diagnosis. The patient was continuing in an expected clinical trajectory while in the hospital. Due to above reasons, this child with mild to moderate asthma exacerbation could have been treated in observational status.

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 is not substantiated.
Appeal type: Medical necessity
Decision: Upheld



Diagnosis: Immunologic Disorder/Other/Nonfamilial Hypogammaglobulinemia; Common Variable Immunodeficiency, unspecified.
Treatment: Pharmacy/Prescription Drugs/Hizentra.
The health plan denied the requested prescription medication, Hizentra.
The health plan's determination is upheld.

This is a male patient who has a diagnosis of Nonfamilial Hypogammaglobulinemia, Common Variable Immunodeficiency, unspecified.
At issue is the medical necessity for the requested health service/treatment of Hizentra.

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

The requested health service/treatment of Hizentra is not medically necessary for this patient. 
The patient has a history of acute renal failure resulting in low immunoglobulin G (IgG), immunoglobulin A (IgA), antibody levels, and low levels of immune cells. IgG levels were low at 362. The IGA level was low at 29. Post-booster pneumococcal titers were 4 out of 23 protective. The treating provider wrote in a letter that the patient has gastrointestinal impairment and hand-wrote that the patient has had recurrent infections. However, according to the clinic note the patient has not had any recurrent Sino pulmonary infections, gastrointestinal infections, or skin abscesses. The patient has had non-specific symptoms of fatigue and decreased exercise endurance. As it is unclear whether the patient has a history of recurrent infections supportive of a humoral immunodeficiency, it cannot be determined that this medication is medically necessary for the patient. The denial reasons are in line with medical literature.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriasis
Treatment: Tremfya
The health plan denied: Tremfya
The determination is upheld.

The patient is a female with moderate to severe psoriasis that includes the scalp, back, and abdomen. The patient has tried and failed topical clobetasol (Olux foam) and also ketoconazole shampoo. The patient also has a history of asthma and allergies. The patient was previously on Otezla but stopped due to diarrhea and a bout of bronchitis. The patient was started on prednisone and antibiotics. Tremfya was started almost three years ago with clearance.

At issue is the medical necessity of the requested health service/treatment of Tremfya.
The health plan's determination of medical necessity is upheld in whole. The requested health service/treatment of Tremfya is not medically necessary for this patient.

Tremfya was and is being prescribed out of convenience instead of true medical necessity. The previous use of prednisone by the patient is noted for triggering and flaring psoriasis when discontinued, and Otezla was (as with Tremfya now) prescribed out of convenience instead of true medical necessity. Only after standard first-line treatment for psoriasis (in particular, methotrexate) has been tried and failed is Tremfya or other second-line therapies truly medically necessary.

Modern dermatology literature [2-5] supports use of the health plan-covered and preferred medications as similarly efficacious to the requested Tremfya, particularly for a patient with a limited history of systemic psoriasis therapy previously utilized, and this literature recommends use of these preferred agents as appropriate for this patient's clinical scenario. Therefore, as per current medical standards of care, Tremfya is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Restless Leg Syndrome.
Treatment: Gabapentin 800mg (milligrams) OR (oral) Tabs.
The insurer denied: Gabapentin 800mg (milligrams) OR (oral) Tabs.
The denial is upheld.

The member is an adult male with restless leg syndrome (RLS). The provider has requested gabapentin 800 mg (milligrams) in the quantity of 5 (five) per day. The requested medication was denied coverage as the quantity exceeds the plan limit.

The proposed treatment is not medically necessary. 

There are no high-quality clinical trials or standard of care guidelines to support that escalating the dose of gabapentin beyond 3600 mg per day is safe or confers additional benefit to persons with any condition, including RLS (restless leg syndrome) Goodman and Brett, 2019.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Acute heavy bleeding
Treatment: Inpatient admission
The insurer denied: Inpatient admission
The denial is upheld

The patient is an adult G2P2 (two pregnancies, two births) female. She presented to the ED (emergency department) with acute heavy bleeding 11 days after a spontaneous vaginal delivery. She has a history of PCOS (polycystic ovarian syndrome) and von Willebrand's type 1. She had a prior hemorrhage after her first delivery, requiring four units of blood. She began with heavy bleeding changing a pad hourly and went to the ED (emergency department). The patient had stable vital signs, blood work, and examination, which revealed some bleeding but not acute. Her hemoglobin was 11. She was given an IV (intravenous) line and fluids. She was admitted for observation. Hematology consult was placed, and they recommended IV (intravenous) tranexamic acid. She received one dose, and the bleeding stopped. She was stable overnight with minimal bleeding.
On day #2 the patient was seen by hematology. She had no further bleeding. She was discharged home with an oral script for tranexamic acid and a follow up visit in 2 weeks. The inpatient stay was denied coverage by the health plan as not medically necessary. This denial is being appealed.

The inpatient admission was not medically necessary.

An outpatient observation bed is an alternate level of healthcare compromising of short stay encounters for patients who require close nursing observation or medical management. It is an area where the patient is observed and assessed to determine a need to be admitted to the hospital as an inpatient. Under the two-midnight rule, established by the Centers for Medicare &amp; Medicaid Services (CMS) in 2013, hospital inpatient admissions are considered reasonable and necessary for patients whose stays cross two midnights. The patient in question was admitted with heavy bleeding. She required observation and nursing care to assist with her medical management of her bleeding. This could have been done in an observation status. It would not have been reasonably expected for the patient's care to span two midnights, nor would the patient's treatment reasonably have been expected to require any other treatment requiring inpatient care, given that her vitals were stable, and the bleeding slowed quickly. The same safety and outcome could have been provided at a lower level of care, such as observation. An inpatient level of care does not follow the accepted standard of medical practice and was not necessary.