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

Diagnosis: pilocytic astrocytoma.
Treatment: Mekinist 0.5 milligrams (mg) TAB.
The insurer is denied coverage for Mekinist 0.5 milligrams (mg) TAB.
The denial is overturned. 

This male patient has a history of pilocytic astrocytoma and worsening pseudomeningocele papilledema and hydrocephalus

Selumetinib, another mitogen-activated protein kinase enzymes (MEK) inhibitor, 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 (ACNS1833, Ref. 1).  This 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 support the notion that Selumetinib is accepted as efficacious in pediatric low-grade glioma.  As highlighted in the study justification, "...data show that MEK-1/2 inhibition is an efficacious strategy in patients with recurrent and progressive PA with the two most common BRAF aberrations and may also be efficacious in LGG [low-grade glioma] patients without these BRAF (gene) alterations, suggesting that this agent may be targeting less common or well understood MAPK [mitogen-activated protein kinase] pathway alterations." 
The use of non-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..."  (Ref 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 in the treatment of this patient. As noted in Kondyli et al (ref 7), "...data shows promising effects with the use of trametinib similar to seumetinib in pilocytic astrocytoma with a molecular alteration of the MAPK pathway."  The choice of trametinib for residual BRAF fusion pilocytic astrocytoma is within standard of care and the literature supports efficacy and tolerability of this agent (ref, 8,9).

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 Mekinist 0.5 milligrams (mg) TAB is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Pyelonephritis

Treatment: Inpatient admission 

The insurer denied coverage for inpatient admission.

The denial is upheld.

This patient with a past medical history of anxiety/ depression, elbow fracture, environmental allergies, narcolepsy presented to emergency department for evaluation of fever, body aches, pain. The patient reported that she was recently diagnosed with a urinary tract infection and was started on Bactrim but was switched to Macrobid. On the day of emergency department presentation, the patient woke up with right flank pain, abdominal pain and fever. Temperature was 101.9 Fahrenheit in emergency department started on intravenous Rocephin. The patient admitted and treated for pyelonephritis. She improved rapidly and was discharged home with outpatient family medicine follow up. 

Per Milliman Care Guidelines (MCG) Urinary Tract Infection (UTI), the patient fails to meet clinical indications for admission to inpatient care. The patient had right flank pain, low grade fever. Urinalysis of kidneys was negative hydronephrosis or obstruction calculi.

The health care plan acted reasonably and with sound medical judgement and in the best interest of the patient. The inpatient admission is not considered medically necessary for this patient.

The insurer's denial of coverage for the inpatient admission is upheld. Medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Recurrent Left Groin Abscess

Treatment: Inpatient hospital admission

The insurer denied coverage for inpatient hospital admission.

The denial is upheld.

This is a patient with past medical history significant for diabetes mellitus, atrial fibrillation, morbid obesity, congestive heart failure (CHF), asthma, recurrent abscesses and obstructive sleep apnea who presented to the emergency department with complaints of worsening left groin pain and swelling. The patient returned after signing out medical advice the day prior. Vitals on presentation included: Temperature 99.1 Fahrenheit, Blood Pressure 135/93, Pulse 91, Respiratory Rate 20, oxygen (O2) saturation 95% (percent) on Room Air. Laboratory results included the following: white blood cell count (WBC)10.2, hemoglobin (HGB)-14.3, hematocrit (HCT)-44.4, creatinine-1.04, glucose-181. The patient was admitted and started on antibiotics for possible recurrent left groin abscess. Previous cultures grew Actinomyces. Infectious Diseases consulted and adjusted antibiotic coverage. Wound care with dressing changes were performed. The patient remained afebrile, hemodynamically stable, and was discharged on oral antibiotics (Augmentin) to continue management as an outpatient.

According to documentation, the patient returned to emergency department after signing out against medical advice because he was "homesick." Otherwise, the patient was afebrile, hemodynamically stable with unremarkable laboratory results including a normal WBC. The patient did not have any evidence for a disseminated infection and further surgical intervention was required. Based on these findings, patient met criteria for observation level of care.   

Prior determination of denial of acute inpatient admission is upheld. 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: Experimental/Investigational
Decision: Upheld

Diagnosis: Astrocytoma
Treatment: Optune Electrical Stimulation Device
The insurer denied the Optune Electrical Stimulation Device. The health plan's determination is upheld.

The patient is a male with history of grade III astrocytoma of the left thalamic location and spinal cord, IDH (Isocitrate dehydrogenase) wild type and MGMT (methylguanine-DNA-transferase) wild type (unmethylated) disease. The patient is currently undergoing adjuvant therapy with radiation and now receiving chemotherapy with Temozolamide. The Optune Electrical Stimulation Device was recommended and is under review. 

The Optune electrical stimulation device has shown to improve survival in patient with glioblastoma in conjunction with adjuvant radiation therapy and chemotherapy. IDH-wild-type anaplastic (grade III) astrocytomas with molecular features of glioblastoma are prognostically similar to IDH-wild-type (grade IV) glioblastoma and have significantly worse outcomes compared with IDH-mutant anaplastic astrocytomas. Optimal management is unclear. Given the similarity to glioblastoma, many experts in the field recommend therapy similar to glioblastoma.
Consensus-based guidelines published by the National Comprehensive Cancer Network (NCCN) include alternating electric field therapy as a treatment option for patients with glioblastoma multiforme (GBM) based on the trial data reviewed above as well as post marketing analysis of >450 patients treated commercially in the United States.
A recent report of post marketing analysis of 11000 patients showed that 6% of patients with high grade astrocytoma were included. This retrospective, global, TTFields (tumor treating fields) safety surveillance analysis revealed no new safety signals, with favorable safety and tolerability comparable to published TTFields/GBM trials.
However, there is no prospective or retrospective case study (pubmed search) to show benefit of TTfields in grade III astrocytoma patients. TTfields remains experimental for patients with astrocytoma. No clinical trials available for this diagnosis using TTfields; and FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma (FORWARD) study was terminated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Astrocytoma
Treatment: Optune Electrical Stimulation Device
The insurer denied the Optune Electrical Stimulation Device. The health plan's determination is upheld.

The patient is a man who was diagnosed with Grade III anaplastic astrocytoma. He was given chemotherapy with radiation. The Optune Electrical Stimulation Device was ordered and is under review.

The proposed Optune electrical stimulation device is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
According to National Comprehensive Cancer Network (NCCN) guidelines, the proposed treatment, Optune electrical stimulation device is only indicated as a category 2B recommendation for patients who have progressed or developed recurrent disease with histology of glioblastoma multiforme, and this patient does not have that pathological diagnosis.
At this time, there are no data that support the use of this treatment for patients with anaplastic astrocytoma, grade III. Therefore, the proposed treatment is not likely to be more beneficial than standard treatment in this case.
Appeal type: Experimental/Investigational
Decision: Upheld

Cancer
Radiation Therapy

Diagnosis: Astrocytoma
Treatment: Optune Electrical Stimulation Device
The insurer denied the Optune Electrical Stimulation Device. The health plan's determination is upheld.

This is a male with and IDH (Isocitrate dehydrogenase) wild-type astrocytoma, World Health Organization (WHO) grade 3, 1p/19q codeletion negative, IDH-. The patient has received temozolamide and radiotherapy. His disease is stable. He has tolerated systemic therapy to date. The Optune Electrical Stimulation Device has been recommended and is under review.

The Optune Electrical Stimulation Device [E0766RR] is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The use of tumor treatment fields (TTF) has not been demonstrated to be of benefit in this clinical scenario. Optune has been demonstrated to be of benefit in grade 4 astrocytoma, but its benefit in this clinical scenario remains unknown and its use is not recommended by the National Comprehensive Cancer Network (NCCN), by the authors of UpToDate, nor by the peer-reviewed literature.
The use of Optune in this scenario remains the subject of ongoing investigation in this scenario in NCT04757662. This patient has not failed his current line of therapy and lacking a benefit to this approach, it is not likely to be more beneficial than standard treatment.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: detoxification

Treatment: hospital admission

The insurer is denied coverage for hospital admission

The denial is overturned. 

This male patient has a history of alcohol abuse

According to the Level of Care for Alcohol and Drug Treatment Referral (LOCADTR) he did require 24-hour treatment as he could not safely and effectively be treated for detoxification in a less restrictive setting as he continued to use large amounts of alcohol, required and received detoxification medication, Ativan, and received Ativan 2 mg once orally [PO] and Ativan 1 mg 7 times p.o. in addition to the Ativan 1 mg IV once in the ER to modify withdrawal from alcohol. He needed 24-hour hospital treatment then as he was at risk for worsened withdrawal symptoms if not in this 24-hour setting then including possible life-threatening withdrawal such as delirium tremens. He continued to drink despite past inpatient alcohol rehabilitation treatment, and he reportedly had multiple episodes of alcohol withdrawal.  It was considered unsafe for him to be treated for alcohol detoxification treatment in a less restrictive level of care.

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 hospital admission is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: COVID-19 pneumonia

Treatment: hospital admission

The insurer is denied coverage for hospital admission

The denial is upheld. 

This male patient has a history of COVID-19 pneumonia.

The patient was seen by infectious diseases (ID) and pulmonary service. As per ID, there was low likelihood of bacterial infection or tuberculosis (TB). It was likely post Covid fibrosis related.
No antibiotics were recommended. Pulmonary initially was recommending fibreoptic bronchoscopy (FOB) but as the patient was already scheduled for outpatient FOB, it was planned to be done in the outpatient setting. No antibiotics were recommended by them also, as low likelihood of infection.

The patient remained stable after admission. He remained afebrile and hemodynamically stable. No hypoxia was noted. There was no significant hemoptysis. The patient was discharged the next day with recommendations to follow up in the outpatient

This patient did not need acute inpatient hospitalization. He could have been placed in observation status (which could be for up to 48 hours) while diagnostic testing and treatment could have been initiated. The patient had low volume non-life-threatening hemoptysis with no significant progression. He was discharged the next day with recommendations to follow up in the outpatient setting. Nothing other than observation was done for this patient.

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 hospital admission is upheld.  The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Iron Deficiency Anemia

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission.

The denial is upheld.

The patient is a female with a history of heavy menses leading to iron deficiency anemia requiring transfusions, who presented to the emergency department (ED) for a very low blood hemoglobin level of 6.5. She noted feeling weak and fatigued. The patient reported taking iron supplements in the past, but discontinued use for the past year due to abdominal discomfort and constipation. In the ED, she received a blood transfusion without incident. The patient was admitted for monitoring during an additional blood transfusion and 2 doses of IV (intravenous) iron therapy. Her post-transfusion hemoglobin level increased to 8.1; she reported less fatigue and weakness. The patient was medically cleared for discharge. All instructions and follow up appointments were explained and provided to the patient.

This patient was symptomatic. In addition, she fulfills the transfusion guidelines for use of blood components: her hemoglobin was less than 8g/dl (grams per deciliter). Thus, transfusion was necessary. In this day and age, transfusions are done routinely in outpatient settings (oncology clinics, infusion centers, even at home). Therefore, the need for transfusion is not a reason for admission.

The transfusion could have been completed in the ED without the need for admission. Following transfusion and IV iron infusion, the patient could have been monitored for a few hours in the ED, her complete blood count (CBC) repeated and then discharged home with a follow up within 24 hours with her primary physician or gynecologist.

Nothing was done in the hospital that could not be done as an outpatient. Milliman Care Guidelines list the clinical indication for inpatient care for patients with anemia. These include active massive hemorrhage, active hemolysis, cognitive impairment, tachycardia, orthostatic changes, heart failure, chest pain, syncope. The patient was stable and did not have any of the above indications for admission.

Based on all of the above, admission was not medically necessary. The health care plan acted reasonably, with sound medical judgment, and in the best interest of the patient.

The insurer's denial of coverage for the inpatient admission is upheld. Medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Nausea, Vomiting
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The denial is upheld. 

The patient is a female with type 1 diabetes. She presented with nausea and vomiting. She had a five day history of feeling unwell.

In the emergency department, the patient had blood pressure of 105/73 mmHg (millimeters of mercury), heart rate of 84 beats per minute, respiratory rate of 18 breaths per minute, temperature of 98.7 degrees Fahrenheit, oxygen saturation of 99% (percent). Point of care glucose was over 500 mg/dL (milligrams per deciliter). She was alert and oriented. Laboratory results showed blood glucose of 516, bicarbonate level of 13, anion gap of 27, beta-hydroxybutyrate of 8.32 mmol/L (millimoles per liter), and pH (potential of hydrogen) of 7.32 on venous blood gas. She was treated with intravenous insulin and fluids and then transitioned to subcutaneous Lantus and lispro insulin. Inpatient stay is under review.

No, the proposed inpatient stay was not medically necessary.

Patients with diabetic ketoacidosis can be safely managed in observation units unless they present with severe alteration of mental status or with critical illness such as sepsis, which is not documented in this case. This patient presented with hyperglycemia with known type 1 diabetes. She presented with mild diabetic ketoacidosis with an initial pH of 7.32 on venous blood gas. Her hyperglycemia quickly improved with intravenous hydration and insulin therapy. She was hemodynamically stable. This patient did not have alteration in her mental status. Her nausea quickly resolved. She did not have acute renal failure. She did not have evidence of an infection. The documentation does not support an acute medical condition that required an inpatient stay. Therefore, the proposed inpatient admission was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Fetal Anemia

Treatment: Inpatient emergency admission

The insurer denied coverage for inpatient emergency admission.

The denial is upheld.

The patient has a history of a prior c (cesarean)-section who was admitted for a percutaneous umbilical blood sampling (PUBS) for suspected fetal anemia. The patient was started on a magnesium sulfate infusion for prophylaxis; food and oral fluids were restricted after midnight. The sampling procedure and intrauterine fetal blood transfusion was completed without complication. She was briefly monitored post-procedure, then discharged home in stable condition. Instructions were given on post-procedure precautions and to follow up with her obstetrician.

This patient needed fetal blood samples to aid in the diagnostic evaluation of fetal anemia.

Prior to fetal viability, fasting blood sugar (FBS) can be performed in a room used for sonographic examinations or in a labor room. After viability, the procedure should be performed in proximity to an operating room since an emergency cesarean delivery may be required if non-reassuring fetal heart rate patterns develop during or after the procedure. The patient is asked not to eat or drink after midnight, the day before the procedure. PUBS is an ambulatory procedure; the patient presents the day of the procedure.

After the desired samples have been obtained, the fetal heart rate is monitored for one to two hours after the procedure using an external fetal heart rate monitor. It is unclear why the patient was admitted the day prior to the procedure. There is no information of any medical condition that warranted a preoperative hospital admission.

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

The inpatient emergency admission is not considered medically necessary for this patient. 

The insurer's denial of coverage for the inpatient emergency admission l is upheld. Medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Meniscus Tear

Treatment: Arthroscopic knee surgery

The insurer denied coverage for arthroscopic knee surgery.

The denial is upheld.

This is the case of a patient with history of cardiac transplant years ago and longstanding back issues including an extended fusion. The patient still receives treatment at the pain clinic and has had some associated back complaints. He believes that he developed some knee discomfort years following his cardiac transplant. The patient was evaluated previously and told he had a meniscus tear that needed treatment and, on another occasion, was told he was too young and there were some concerns regarding the location of treatment given his cardiac status. His pain has gradually worsened, and he reports the pain is worse over the medial joint line when pivoting, twisting, descending stairs and pushing an object with the inside of his foot. He had some temporary relief in the past with an injection, but his symptoms recur. Various options were discussed, including continued conservative care, pharmacotherapy, and surgical intervention. The patient opted to move forward with an arthroscopy. 

The records show the patient was evaluated for the first time by a specialist. The complaint was right knee pain for a duration of years. His physical examination was significant for a flexion contracture (he was only able to extend to 10 degrees) with imaging studies showing degenerative changes (arthritis). These findings are consistent with progressive osteoarthritis. 

The scientific literature reports people who undergo arthroscopy with underlying arthrosis do not do well. Recommendations are: this surgery should not be performed because there is an increased rate of progression to arthroplasty. Treating meniscal pathology in the presence of joint arthrosis does not address the underlying problem of a degenerative process. 

Conservative course of treatment should be provided prior to surgical intervention. This would consist of a course of physical therapy, non-steroidal anti-inflammatory drugs (NSAIDs), brace and/or injections (cortisone). The records show non-operative treatment was discussed but not provided. Surgery was performed. 

The post-surgical course was significant for ongoing problems with bracing/injections now recommended. 

In conclusion, the operation was not necessary based upon clinical presentation of underlying osteoarthritis and lack of prior conservative management. 

There were no extenuating circumstances to warrant the procedure. The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for the arthroscopic knee surgery provided is not substantiated. The insurer's denial is upheld.