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

Diagnosis: Acute Migraines

Treatment: Ubrelvy

The insurer denied coverage for Ubrelvy.	

The denial is upheld.

This case involves a female patient who has been recommended to utilize Ubrelvy due to ongoing headaches. The documentation indicated she was complaining of headaches. The documentation indicated she will typically get migraine around the time of her menstruation. She sometimes can have them other times as well. She states she typically has 2-6 headaches a month. They may be associated with nausea, occasional vomiting, photo and phonophobia. She has presented to the Emergency Department 3 times for her headaches. The documentation detailed her migraines began after she was diagnosed with Cushing's disorder and a pituitary tumor resection. The physical examination revealed no acute distress. There was a negative bilateral Spurling's. Examination did not reveal any significant findings. The physician indicated she should undergo a magnetic resonance imaging (MRI) scan and utilize medications. It was recommended she begin prophylactic treatment with riboflavin twice a day. Given she has high blood pressure the physician detailed he would avoid caffeine-containing agents such as Fioricet or triptan's. Ubrelvy was recommended. 

The patient was seen by Neurology for a follow-up. Since her last visit she stated she only had 4 migraines over 2 months. She stated that prior to her headaches the use of Ubrelvy helped. There were no other complaints. The examination did not reveal any significant abnormalities and it was recommended she continue with medication use. 

A letter of medical necessity indicates the requested medication has been utilized for acute migraines. The physician detailed the patient is unable to utilize triptan medications due to high blood pressure.

The submitted documentation does indicate the patient was recommended to utilize the requested Ubrelvy due to the inability to utilize triptans or other medications such as Fioricet. However, there is no documentation indicating she cannot trial Nurtec. As noted by Up to Date both are calcitonin gene-related peptide (CGRP) antagonists and "there are positive randomized controlled trials for rimegepant (Nurtec) and ubrogepant (Ubrelvy) in acute migraine." Therefore, at this time the prior determination remains upheld.

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

The insurer's denial of coverage for Ubrelvy is upheld. Medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis

Treatment: medication Dupixent (Dupilumab) 300 milligrams per 2 milliliters, subcutaneous in a pre-filled syringe

The insurer denied coverage for medication Dupixent (Dupilumab) 300 milligrams per 2 milliliters, subcutaneous in a pre-filled syringe.

The denial is overturned.

The patient is an infant weighing 15.5 kilograms with a diagnosis of atopic dermatitis affecting 40% (percent) of the total body surface area (TBSA).  The patient has failed therapy with topical steroids and phototherapy.  The requested medication is dupixent.  

Dupixent is medically necessary for the treatment of the patient's diagnosis, atopic dermatitis.  The patient is a child with limited treatment options given her age.  The patient has failed topical therapy with steroids as well as light therapy.   The extent of disease involvement, affecting 40% TBSA, requires systemic therapy.  Case reports exist for the safe and effective use of Dupixent in children under the age of 6.  Dupixent is approved for use in the treatment of the patient's atopic dermatitis under close medical supervision and at an appropriate dosing schedule at the discretion of the treating physician.  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 the medication Dupixent (Dupilumab) 300 milligrams per 2 milliliters, subcutaneous in a pre-filled syringe is reversed. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: disseminated brain and spine cord astrocytoma with a BRAF duplication.

Treatment: coverage of Koselugo 10 milligrams (mg) capsule

The insurer is denied coverage for coverage of Koselugo 10 milligrams (mg) capsule.

The denial is overturned. 

This male patient has a history of diffuse leptomeningeal glioneuronal tumor.

Data from a phase 3 trial has passed all regulatory hurdles based on the perceived equipoise between standard Vincristine + Carboplatin compared to Selumetinib. The fact that this phase 3 study has been approved by the Children's Oncology Group, Cancer Therapy Evaluation Program (CTEP) and other regulatory hurdles supports the notion that Selumetinib is accepted as efficacious in pediatric low-grade glioma (LGG). As highlighted in the study justification, "data show that MEK-1/2 inhibition (mitogen-activated protein kinase kinase) is an efficacious strategy in patients with recurrent and progressive pilocytic astrocytoma (PA) with the two most common BRAF (v-raf murine sarcoma viral oncogene homolog B1) aberrations and may also be efficacious in LGG patients without these BRAF alterations, suggesting that this agent may be targeting less common or well understood mitogen activated protein kinase (MAPK) pathway alterations." Selumetinib is currently considered within standard of care for previously treated recurrent/progressive low-grade glioma as noted in the body of a currently open Children's Oncology Group clinical trial for NEWLY diagnosed patients with low grade glioma. (1) 

References included in the providers appeal letter also support the choice of selumetinib. (see Ref 2, 3)

Durable stable disease during treatment of a recently progressive tumor is considered a treatment response in pediatric low-grade glioma. The use of non- Food and Drug Administration (FDA)-approved drugs for a specific condition is unfortunately common and standard of care in pediatric oncology. As detailed in the citations below, and stated most clearly in Hirschfeld et al, "More than 100 drugs have been approved by the Division of Oncology Drug Products of the FDA for the treatment of malignancies. Only 15 have pediatric use information in their labeling, which is less than 50% of the drugs commonly used in the treatment of pediatric malignancies..." (4-6)

As such, it is common for Pediatric Oncologists to use a drug of a certain class for a pediatric and young adult tumor for which there is no FDA-approval as long as there is rationale based on preclinical and clinical trial data. Such rationale exists in this case. Given the life-threatening condition and lack of any FDA-approved therapy, it was appropriate and within standard of care for the treating physician to use a commercially available MEK inhibitor, selumetinib, in the treatment of 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 the inpatient hospital admission is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriatic Arthritis.
Treatment: Otezla.
The insurer denied the Otezla.
The denial is overturned. 

The patient is a female with history of psoriatic arthritis and psoriasis.  The patient was started on monotherapy biologic disease modifying antirheumatic drug (DMARD) Enbrel approximately two years prior. Otezla was added to her regimen recenty after she was flaring post COVID-19 infection.  Since starting Otezla, she has clinically been doing well.

Yes, the treatment with Otezla is medically necessary.
The patient has a history of psoriasis and psoriatic arthritis.  The patient was doing well prior on monotherapy Enbrel.  Post COVID-19 infection, the patient had flaring of her disease, and then Otezla was added and now overall, the patient is clinically stable.  While Otezla is not currently approved by the Food and Drug Administration (FDA) to be used in combination with a biologic DMARD (disease-modifying antirheumatic drug), there are many studies evidencing that Otezla can be safely and effectively combined with a biologic DMARD (disease-modifying antirheumatic drug) such as Enbrel with good safety and efficacy.  This patient has proven good efficacy in treatment of her disease for the last year without any safety concerns.  Therefore, the treatment with Otezla would be medically necessary for continuation of care.

The patient has been utilizing Otezla with Enbrel for the last year with good clinical results.  There have been no safety concerns that have arisen with this patient with the combination of Otezla and Enbrel.  The patient has demonstrated clinical remission with the use of combination therapy, and clinical studies do show safety and efficacy with combination therapy.   Therefore, at this time the treatment with Otezla is medically necessary. Therefore, the health plan did not act reasonably with sound medical judgment and the best interest of the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hypogonadism.
Treatment: Testosterone Topical Solution, Pre-service.
The insurer denied the Testosterone Topical Solution, Pre-service.
The denial is upheld. 

This is a male with hypogonadism. He has tried and failed testosterone transdermal gel 50 milligrams per five gram packets (1%). He has a fear of needles. He has been doing well on testosterone topical solution 30 milligrams per actuation for approximately over a year. The patient's testosterone level was 311 five months ago. The patient has been taking anastrozole. 

The request for testosterone topical solution is under review. The prior request for testosterone topical solution was denied as the patient was taking an aromatase inhibitor.

No, the proposed testosterone topical solution is not medically necessary.
The Endocrine Society guidelines on the management of male hypogonadism do not support the use of anastrozole in conjunction with testosterone supplementation for the treatment of male hypogonadism. The safety and efficacy of anastrozole along with testosterone topical solution supplementation is unknown, and it may cause hyperandrogenism, which can result in decreased high density lipoprotein (HDL) cholesterol and increased hemoglobin levels. Therefore, the proposed testosterone topical solution, in conjunction with anastrozole, is not medically necessary.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Osteoarthritis.
Treatment: Formulary exception for Pennsaid, Pre-service.
The insurer denied the Formulary exception for Pennsaid, Pre-service.
The denial is overturned.

The patient is a female with osteoarthritis/back pain. She has been prescribed PennSaid (Diclofenac Na [sodium] solution).  The request denied as the formulary alternatives have not been tried and failed.  Per the attached formulary requirements, three or more alternatives must be tried and failed.

Yes, the health plan should cover the Formulary exception for Pennsaid.
The patient is a female with osteoarthritis/back pain, who has been prescribed PennSaid (Dicolfenac Na [sodium] solution).  The request denied as the formulary alternatives have not been tried and failed.  The patient has failed Voltaren gel and over the counter creams. Per the attached formulary requirements, three or more alternatives must be tried and failed.  Attached documentation shows that the patient has failed 3 or more formulary alternatives, which include diclofenac gel, Diclofenac sodium 1.5%, oral NSAIDS including Mobic, Naproxyn and Diclofenac.  Given the above, the formulary criteria has been met, and all reasonable alternatives have been tried.  All alternatives have been ineffective. Therefore, it cannot be determined if the requested medication would be ineffective for the patient, or effective or more effective than the formulary alternatives, as its base compound is the same.  However, the formulary alternatives have been failed, and given that Voltaren gel has been tolerated, it is unlikely the patient would have adverse effects from the formulary preferred medication.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chest Pain
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The denial is overturned. 

The patient is a male with a past medical history significant for HTN (hypertension), dyslipidemia, diabetes mellitus type 2, end-stage renal disease on dialysis, and CAD (coronary artery disease) with a prior stent placement in LAD (left anterior descending) artery. He presented with complaints of chest pain and left arm pain that started during hemodialysis.

The patient was hypertensive in the ER (emergency room). His troponin was elevated at 0.2, consistent with myocardial damage. Given the elevated cardiomarkers, the patient was admitted to telemetry for suspected ACS (acute coronary syndrome). He was seen in consultation by cardiology with a plan for possible catheterization, should his troponins continue to rise. The next day, his troponin level trended down, and he was discharged home on medical therapy for CAD (coronary artery disease) with a plan for outpatient follow-up.

Yes, the inpatient admission was medically necessary.

The patient presented with new onset chest pain, suspicious for unstable angina. The patient had multiple risk factors for CAD (coronary artery disease), including diabetes, as well as a known history of coronary artery disease, requiring percutaneous revascularization. His cardiac enzymes were elevated, consistent with non-ST (interval between ventricular depolarization and ventricular repolarization in an electrocardiogram) elevation MI (myocardial infarction), and he was admitted for suspected ACS (acute coronary syndrome), with a plan for possible catheterization. Given this presentation, suspicion for an acute coronary syndrome, as well as risk factors and known CAD (coronary artery disease), it would be consistent with the current standard of care that this patient be managed in an inpatient setting. Therefore, the requested inpatient admission was medically necessary in this clinical setting.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Acute cholecystitis. 
Treatment: Inpatient hospital admission. 

The insurer denied coverage for inpatient hospital admission. 

The denial is upheld. 

This is an adolescent with no significant past medical history. She presented to the emergency room (ER) with complaints of right upper quadrant (RUQ) abdominal pain. Heart rate and blood pressure were low. An abdominal ultrasound (US) revealed cholelithiasis. Liver enzymes were elevated. The impression was biliary colic versus acute cholecystitis. 

Acute cholecystitis and biliary complaints are a common inpatient diagnosis. Acute cholecystitis is also estimated to attribute to millions of ambulatory visits each year, and is a leading cause of hospital admissions [1]. Studies have shown that ambulatory laparoscopic cholecystectomy is safe and avoids an overnight hospital stay [2, 4, 5]. Factors that contribute to admission after laparoscopic cholecystectomy include drain placement, conversion to open surgery, persistent abdominal pain, nausea, and vomiting [3]. In patients without abnormalities of the bile duct or abnormal liver function tests, ambulatory laparoscopic cholecystectomy is safe and feasible [5]. 

Per the clinical documentation, this patient presented to the emergency department (ED) with a one-week history of epigastric abdominal pain. There was no associated nausea and vomiting. Vital signs in the ED were within normal limits. An ultrasound indicated cholelithiasis with no evidence of wall-thickening. A hepatobiliary iminodiacetic acid (HIDA) scan demonstrated biliary dyskinesia. The total bilirubin was within normal limits, but the alanine transaminase and aspartate aminotransferase were elevated at 402 and 206, respectively. White blood cell count was slightly elevated at 14.03. An magnetic resonance cholangiopancreatography (MRCP) was performed and demonstrated "no evidence of biliary ductal dilatation or choledocholithias." The patient was taken to the operating room for a laparoscopic cholecystectomy. There were no reported complications. The patient was discharged. There were no reported postoperative complications. The patient was discharged within 24 hours after the procedure. There were no reported complications or indications for a delay in surgical intervention after all imaging studies were completed. Peer-reviewed literature indicates that laparoscopic cholecystectomy can successfully be performed with a period of observation. Per provided clinical documentation, inpatient admission was not medically necessary. 

The health plan acted reasonably with sound medical judgment 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.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: left hand cellulitis
Treatment: inpatient hospital admission
The insurer is denied coverage for inpatient hospital admission.
The denial is upheld. 

This male patient has no significant past medical history.

The patient was admitted to the hospital with a possible left hand cellulitis and was started on intravenous antibiotics (Unasyn). He received tetanus, diphtheria, and pertussis (Tdap) vaccine. X-ray of the left hand showed no fracture or dislocation. Orthopedics consulted. The patient remained afebrile, and hemodynamically stable. He signed out of the hospital against medical advice (AMA).

According to documentation, the patient was admitted with a left hand cellulitis. Otherwise, he was afebrile, hemodynamically stable with unremarkable laboratory findings except for a mildly elevated WBC. There was no evidence of a disseminated infection, no surgical intervention was required, and patient had no co-morbid conditions. Based on these findings, patient met criteria for observation level of care. He did not fulfill criteria for acute care hospitalization.

The health plan did act reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for the inpatient hospital admission is upheld.  The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: psoriasis.

Treatment: Cimzia.

The insurer is denied coverage for Cimzia.

The denial is overturned. 

This patient has a history of psoriasis.

The patient has failed topical therapy as well as numerous biologics, including Enbrel, Humira, Stelara, and Ilumya.  The patient has been successfully treated with Cimzia with a decrease in body surface area (BSA) from 10% to <1% while on Cimzia.  Although, other preferred drug alternatives exist which may be equally or more efficacious, the patient has failed treatment with four prior biologic medications.  The documentation does not provide any evidence of adverse reaction to Cimzia and notes clearing of her signs and symptoms of disease in contrast to prior alternatives.  

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 the Cimzia is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Breast Cancer
Treatment: breast surgery: removal of intact breast implant and revision of reconstructed breast 
The insurer denied breast surgery: removal of intact breast implant and revision of reconstructed breast.
The determination is upheld.

The patient has a history of breast cancer and underwent bilateral breast reconstruction with silicone implants. Her surgeon recommended replacement of the implants, fat grafting and breast scar revision. At issue is the medical necessity of the requested procedures.

The records do not document any health issues related to the patient's breast implants and scars. The provider's note indicates that overall the patient is happy with the reconstruction and would like a higher profile and larger new implants. She also is requesting breast scar revision. The records do not document a medical indication for implant exchange. She is not documented to have severe capsular contracture, infection or implant rupture. According to the American Society of Plastic Surgeons Position Paper titled "Reoperation on Women with Breast Implants", breast implant replacement is medically necessary for any of the following indications if the original implants were placed for reconstructive indications, as was the case for this patient:

1) Broken or failed implant

2) Infection

3) Implant extrusion

4) Siliconoma or granuloma

5) Interference with diagnosis or treatment of breast cancer

6) Breast pain

7) Painful capsular contracture

8) Implant malposition

This patient does not have any of these conditions. The records do not include photos that show severe scarring. Her scars would not be expected to undergo changes or become symptomatic many years after surgery.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic back pain. 

Treatment: Physical therapy, 2 visits. 

The insurer denied coverage for physical therapy, 2 visits. 

The denial is upheld. 

This is a male patient who has chronic back pain.  Treatment included 17 physical therapy sessions.  Currently under review is the medical necessity of 2 additional physical therapy visits.

The physical therapy notes do not document evidence of significant improvement for strength, range of motion or pain ratings.  After more than 3 months of therapy and 17 physical therapy sessions, the patient should be independently and routinely performing a home exercise program.  Given the lack of clinical support, the requested additional physical therapy treatments are considered maintenance treatment and not medically necessary.  

The healthcare plan acted reasonably, with sound medical judgment and in the best interest of the patient.  

The insurer's denial of coverage for physical therapy, 2 visits is upheld. Medical Necessity is not substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Type 2 Diabetes Without Complications
Treatment: Formulary exception for Metformin Hydrochloride ER 1000mg F Tab
The insurer denied the Formulary exception for Metformin Hydrochloride ER 1000mg F Tab
The denial is overturned.

The patient is a male diagnosed with T2DM (type 2 diabetes mellitus). This request is for Metformin Hydrochloride ER (extended release) 1000mg (milligrams) Tab. As reported, he has been on Metformin Hydrochloride ER (extended release) 1000mg (milligrams) Tab for approximately four years and has been well-controlled. The prior authorization form reports that the patient has tried formulary alternatives and had gastrointestinal upset.

Yes, the health plan should cover the Formulary exception for Metformin Hydrochloride ER (extended release) 1000mg (milligrams).
Metformin is still the best first-line medication for treating type 2 diabetes [1].  There are fewer adverse events and better compliance with extended release metformin [2, 3, 4, 5, 6, 7]. The request is for metformin ER (extended release). The patient is reported to have tried formulary alternatives and had an adverse reaction in the form of gastrointestinal upset. Given the fact that the patient had adverse events with the formulary alternatives, the health plan should cover the Formulary exception for Metformin Hydrochloride ER (extended release) 1000mg (milligrams).