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

Diagnosis: Noninfective Gastroenteritis and Colitis.
Treatment: Inpatient admission.
The insurer denied the inpatient admission.
The denial is overturned.

The patient is a male. He was transferred from another acute care facility with complaint of lethargy, diarrhea, headache, nausea, and mild congestion.

The health plan denied coverage of the inpatient admission, because they considered the admission not medically necessary.

Yes, the Inpatient admission was medically necessary.
The patient is a male who was transferred from another acute care facility with complaint of lethargy, diarrhea, headache, nausea, and mild congestion. The patient was in the ED (emergency department) earlier on the same date and had three episodes of brown-green diarrhea in the ED (emergency department). Labs done at the transferring ED (emergency department) was notable for leukocytosis with neutrophilia, hyponatremia, low CO2 (carbon dioxide) and borderline glucose level (67). Imaging and culture were done. The patient was given IV (intravenous) fluids, IV (intravenous) antibiotics, and transferred for further evaluation and treatment of lethargy and leukocytosis of unknown etiology. Upon hospitalization, the patient was given IV (intravenous) fluids and placed on a clear liquid diet. Subsequently, leukocytosis resolved and workup including respiratory viral panel was negative. The patient was afebrile, hemodynamically stable, and able to tolerate a regular diet, and therefore was discharged the following day. As the patient needed IV (intravenous) fluids as well as monitoring for dehydration, lethargy, hyponatremia, and leukocytosis of unknown etiology, the inpatient admission was medically necessary and appropriate for this pediatric patient.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Overturned

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

The patient is a female whose inpatient hospital admission is under review. The patient presented to the hospital with three days of symptoms, including facial pain and swelling, fever, and chills. The patient was seen at urgent care and placed on topical and oral antibiotics but noted no improvement. 

In the emergency room, the patient's vital signs were as follows - temperature (T): 96.3, pulse (P): 119, blood pressure (BP): 143/75, and respiratory rate (RR): 20. General assessment revealed the following - head, ears, eyes, nose, and throat examination (HEENT): left maxillary and mandibular swelling with tenderness over paranasal and infraorbital region, with swelling, no erythema; neck assessment: tender anterior cervical lymphadenopathy (LAD); chest examination: normal; cardiovascular system (CVS): tachycardia; and abdomen examination: normal.  The patient's laboratory values revealed: white blood cell (WBC): 9.2; hemoglobin (Hg): 15.3; hematocrit (Hct): 43.8; platelets (Plt): 169; sodium (Na): 140; potassium (K): 4.0; chloride (Cl): 107; carbon dioxide (CO2): 29; blood urea nitrogen (BUN): 12, and creatinine (Cr): 0.56.  

In the emergency room, the patient was thought to have facial cellulitis that had failed outpatient management, as well as sepsis that required inpatient admission and intravenous (IV) treatment with cefazolin. After several days, the patient improved and was sent home on oral (PO) antibiotics.

Yes, the proposed inpatient hospital admission was medically necessary.
The patient met inpatient admission and intravenous (IV) treatment of cellulitis according to guidelines from the Infectious Diseases Society of America (IDSA).  The patient had failed outpatient management.  In addition, she had systemic signs of infection (tachycardia) (1).

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

This admission was warranted, supported by Infectious Diseases Society of America (IDSA) guidelines. Failure to admit such as a patient can lead to loss of function, septic shock, or death.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Astrocytoma
Treatment: Mekinist
The insurer denied Mekinist.
The health plan's determination is overturned. 

The patient under review is a girl who was diagnosed with a suprasellar grade II pilomyxoid astrocytoma with leptomeningeal metastases to the spine. Her diagnosis was further complicated by associated diencephalic syndrome resulting in severe failure to thrive. She underwent tumor biopsy and ventriculoperitoneal (VP) shunt placement. She was treated as per the Bably POG (Personalized OncoGenomics Program) protocol with 5 cycles of chemotherapy including cytoxan, vincristine, cisplatin, and etoposide. She had a prolonged hospitalization for management of her diencephalic syndrome and electrolyte disturbances related to cerebral salt wasting and chemotherapy toxicity, necessitating placement of a G (gastrostomy)-tube. Surveillance magnetic resonance imaging (MRI) showed progression of disease. She was then treated with low dose cisplatin resulting in toxicity without disease response.

Mekinist (Trametinib) is likely to be more beneficial than any other treatment for this child's life threatening disease. This patient has been treated with multiple lines of conventional cytotoxic chemotherapy complicated by serious toxicities and side effects, but unfortunately continues to experience refractory disease. While she has shown some response in the spinal leptomeningeal disease, her primary tumor continues to progress. Her tumor has clearly demonstrated that it is non-responsive to conventional chemotherapy and radiation at her very young age would result in serious unacceptable long-term cognitive dysfunction. Therefore, a targeted therapeutic approach with Trametinib is an appropriate option for this baby and may offer her only chance for survival. Trametinib has the potential to control this child's disease by inhibiting further growth and even leading to a partial or complete response, granting her the best chance of survival with limited toxicity and optimal quality of life.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Astrocytoma
Treatment: Mekinist
The insurer denied Mekinist.
The health plan's determination is overturned. 

The patient is a female who presented with a grade II suprasellar pilomyxoid astrocytoma with leptomeningeal involvement. She had failure to thrive, excessive vomiting, and imaging confirmed the tumor. Biopsy was performed with ventriculoperitoneal (VP) shunt placement for obstructive hydrocephalus. She had a prolonged hospitalization for treatment of her failure to thrive and diencephalic syndrome. She was treated with 2 cycles of chemotherapy (cyclophosphamide and vincristine) per a modified Baby POG (Personalized OncoGenomics Program) therapy and had stable disease. 

Mekinist 0.5 mg tab is likely to be more beneficial than any standard treatment for the patient's life-threatening disease.

This patient has a history of a progressive, recurrent pilocytic astrocytoma for which Mekinist is being recommended as a targeted therapy based on genetic changes noted within the patient's specific tumor. The use of Mekinist is clinically appropriate based on the current peer-reviewed medical literature. As a young child with a progressive pilocytic astrocytoma, treatment options are limited and the patient has already failed the more standard forms of chemotherapy. There have ben several reports of the response of Mekinist in the treatment of low grade gliomas. As per Miller et al, two patients with inoperable chemotherapy-resistant optic pathway tumors showed a response to Mekinist. Mekinist has been found to have benefit in the treatment of BRAF mutated gliomas, such as the one that this patient has. This patient has limited treatment options at this time. She is not a candidate for further surgery, has failed chemotherapy and is not a candidate for radiation therapy at this time. Mekinist has a strong possibility to be effective in preventing further tumor growth in this patient and potentially prolonging her life.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Astrocytoma
Treatment: Mekinist
The insurer denied Mekinist.
The health plan's determination is overturned. 

The patient is a young female who was diagnosed with a grade II suprasellar pilomyxoid astrocytoma with leptomeningeal involvement. She had a biopsy and placement of a ventriculoperitoneal (VP) shunt to relive obstructive hydrocephalus. She was treated with 2 cycles of chemotherapy consisting of Cytoxan and vincristine per the modified baby POG (Personalized OncoGenomics Program) protocol. She was then treated with cycle 3 cisplatin and etoposide. Cycle 4 chemo of Cytoxan and vincristine was given. An magnetic resonance imaging (MRI) of the brain and spine showed progressive disease with enlargement of the primary tumor.

MEKINIST 0.5MG (milligrams) TAB is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. A phase 2 clinical trial has shown significant response to (MEKINIST) trametinib for pediatric low grade gliomas. Clinical trials and publications support the use of trametinib for de novo and progressive low grade gliomas.

There is ample clinical trial data and results as well as multiple peer reviewed publications supporting the use of trametinib in de novo or progressive pediatric low grade gliomas.

This patient with progressive low grade pilomyxoid astrocytoma should be treated with trametinib.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Breast Cancer
Treatment: Genetic Testing (Foundation One CDX) 
The insurer denied the Genetic Testing (Foundation One CDX). 
The denial is upheld.

The patient is a female with triple-negative breast cancer. A mastectomy was performed and the pathology is that of a metastatic spindle cell cancer. Foundation One is being done to help define the primary.

No, the health plan should not cover the requested genetic testing.

This use of Foundation One is experimental/investigational.

No, the requested genetic testing is not more beneficial.

Cancer of unknown primary (CUP), by definition, is a metastatic disease with an unidentifiable primary tumor. Patients with CUP are generally treated with empiric chemotherapies, such as taxanes and platinum-containing regimens; however, clinical outcomes remain poor. The use of Foundation One to determine a primary is not a validated use of this test.

Per Inserro, in discussing a study by Hayashi, et al, "The study describes how RNA [ribonucleic acid] sequencing and DNA [deoxyribonucleic acid] sequencing for selected genes were performed simultaneously to evaluate gene expression and alterations in order to predict tumor origin.

Unless patients with cancer of unknown primary site (CUP) have other factors working for them, many have poor survival time using platinum-taxane chemotherapeutics, with a median overall survival (OS) of just 6 to 12 months.

A recently published study describes how RNA [ribonucleic acid] sequencing and DNA [deoxyribonucleic acid] sequencing for selected genes were performed simultaneously to evaluate gene expression and alterations in order to predict tumor origin. Based on the data, the researchers ran an algorithm they developed in an effort to predict the site of the tumor.

Then, per those results, patients received site-specific therapy according to the predicted site and detected gene alterations.

The phase 2 nonrandomized clinical trial was carried out at 19 centers in Japan and enrolled 111 previously untreated patients with CUP [cancer of unknown primary].

The efficacy analysis included 97 patients who had undergone pathological evaluation by immunohistochemistry, CAT [computerized axial tomography] scans from the chest to pelvis, and a positron emission tomography scan."

It concluded that the results show that, "site-specific treatment, including guided targeted therapy based on next-generation sequencing, is a promising strategy for patients with cancer of unknown primary site and warrants further investigation in a randomized clinical trial."

Other studies as well indicated that it is feasible to identify mutations and deliver treatments for them, but it remains unproven that this approach is better than broad-based chemotherapy standard of care.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Breast Cancer
Treatment: Genetic Testing (Foundation One CDX) 
The insurer denied the Genetic Testing (Foundation One CDX). 
The denial is upheld.

The patient in this case is a woman diagnosed with breast cancer. Foundation One testing was ordered. She underwent left total mastectomy with node dissection. She was found to have a metaplastic carcinoma.

No, the health plan should not cover the requested genetic testing.

No, the genetic testing is not more beneficial.

Foundation One testing is a next generation sequencing assay that is done to look for genomic alterations in tumor tissue. This test includes over 300 genes.  It is done to try to find potentially effective treatment options. There is currently no evidence based on the results of any prospective clinical trial that has shown use of broad molecular profiling can improve overall health outcomes. This test is not recommended as a standard test known to improve overall health outcomes by NCCN (National Comprehensive Cancer Network) guidelines. Given these considerations, this test is not more beneficial than any standard intervention.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: foot pain/diabetic neuropathy
Treatment: spinal cord stimulator
The insurer denied Outpatient Procedure: Neurostimulator Insertion. 
The health plan's determination is overturned. 

This is a male with a history of diabetic neuropathy who has bilateral foot pain. His pain is constant, burning, with a pain level 9/10. He had tried Lyrica, Gabapentin, Effexor, Oxycodone and Cymbalta without adequate pain relief. An electromyography (EMG) revealed evidence of prediabetic neuropathy. Spinal cord stimulation (SCS) was recommended to manage his persistent severe pain.

Outpatient Procedure: Neurostimulator Insertion is medically necessary for this patient.
This patient has painful diabetic neuropathy. There are strong clinical evidence to show SCS is effective for painful diabetic neuropathy. This patient has failed conservative treatments. It is medically necessary to consider SCS in this case. This patient has severe pain from diabetic neuropathy. He had failed extensive treatments including Lyrica, Gabapentin, Effexor, Oxycodone and Cymbalta. His pain level is 9/10. Further interventions such as SCS are required to relieve his severe pain.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate Cancer
Treatment: OncotypeDx Genomic Prostate Score Test
The insurer denied the OncotypeDx Genomic Prostate Score Test
The denial is upheld.

This male with prostate cancer had the Oncotype DX Prostate Cancer Assay performed. The original biopsy was positive and demonstrated a Gleason 3+3=6 adenocarcinoma in three of 14 cores. The clinical stage was T1c. The PSA ( prostate-specific antigen) was less than (<) ten.

No, the proposed treatment was not medically necessary.

The following criteria were not met:
Medical Necessity:
1) in accordance with Generally Accepted Standards of Medical Practice
2) clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for your Sickness, Injury, Mental Illness, substance use disorder disease or its symptoms
3) not mainly for your convenience or that of your doctor or other health care provider
4) not more costly than an alternative drug, service(s) or supply that is at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of your Sickness, Injury, disease or symptoms."

Per American Urologic Association (AUA) Guidelines:
 "14. Among most low-risk localized prostate cancer patients, tissue based genomic biomarkers have not shown a clear role in the selection of candidates for active surveillance. (Expert Opinion)"

Guideline Statement 32:

Tissue based genomic biomarkers have not shown a clear role in active surveillance for localized prostate cancer and are not necessary for follow up. (Expert Opinion)

This patient has a low-risk prostate cancer.

The National Comprehensive Cancer Network Guidelines state:
"In summary, although molecular test results can provide additional guidance to patients, only limited data of prostate cancer specific-survival are available, and whether patient outcomes are improved with use of these tests is unclear." 
"[A]ny of these tests may be considered to aid management decisions, but they are not required for standard of care at this time."

Yes, the health plan acted reasonably, with sound medical judgment and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Central Nervous System/Neuromuscular Disorder - Parkinson's Disease.
Treatment: Skilled Nursing Facility.
The insurer denied Altered Level of Care.
The denial is upheld. 

This is a female with Parkinson's disease, chronic obstructive pulmonary disease (COPD) and lupus who was residing at a Skilled Nursing Facility (SNF) facility for skilled care. The facility is appealing the health plan's decision for denial of SNF care.
At issue is the medical necessity of Altered Level of Care.

The health plan's determination of medical necessity is upheld in whole.

No, the requested health service/treatment of Altered Level of Care is not medically necessary for this patient.

This patient has no skilled needs shown in the documentation requiring care. The SNF level of care is therefore not medically necessary. The patient has no wounds and no rehabilitation need that warrants continued SNF level of care. In addition, her medications are stable and do not require skilled nursing care.
Therefore, the requested health service/treatment of Altered Level of Care is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cholecystitis
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission
The denial is overturned

The patient is a pregnant female who presented to the emergency room (ER) with complaints of abdominal pain. An abdominal ultrasound revealed an impacted stone in the neck of the gallbladder. The right upper quadrant (RUQ) was tender to palpation. The patient was admitted with cholelithiasis. She was kept on nothing by mouth (NPO). External fetal monitoring (EFM) and nonstress tests (NST) were done. She was given intravenous (IV) Zosyn, and pain medications as needed (PRN). Her condition did not improve so she underwent a percutaneous cholecystostomy. She was discharged later that day.

The patient was pregnant and was diagnosed with cholecystitis. Cholecystitis should be considered in the evaluation of any pregnant woman with abdominal complaints. Acute cholecystitis can mimic many other intra-abdominal problems, both obstetric and non-obstetric. Most patients respond to conservative management, with minimal increase in maternal or fetal morbidity and mortality. A few will not respond to therapy or will have severe complications requiring more aggressive management, including surgery.

The initial management of pregnant patients with gallstone disease is supportive and includes pain control, intravenous fluid therapy, and, for patients with acute cholecystitis, antibiotic therapy. Additional imaging and repeat laboratory studies are indicated to assess for potential complications if symptoms worsen.

This patient was pregnant and was diagnosed with cholecystitis. Admission for intravenous fluid, antibiotics and pain management and close monitoring for worsening condition that could put the patient and the fetus at risk was medically necessary. In this case, due to non-improvement in the patient's condition, a percutaneous cholecystostomy was medically necessary. Following the procedure, the patient was discharged home with a drain in place.

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 inpatient admission is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: Anemia.
Treatment: Inpatient admission.

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

The patient was referred to the emergency room by her nephrologist for rectal bleeding for 4 weeks with melanotic stools and associated anemia. She had a past medical history significant for iron deficiency anemia, chronic kidney disease, diverticulosis, hypertension, and diabetes mellitus. Upon presentation to the emergency department, the patient was described as short of breath on exertion, she was lightheaded, fatigued, having chills, positive guaiac, with relatively stable vital signs, but she had pale skin and black stool. Significant labs included white blood count (WBC) 11.5, Neutrophils 77.4, Absolute Neutrophil Count (ANC) 8.9, hemoglobin (Hgb) 6.0, hematocrit (Hct) 20.9, glucose 157, blood urea nitrogen (BUN) 65, Creatinine 4.40, potassium (K+) 5.3, Chloride (Cl) 113, carbon dioxide (CO2) 17.2 and estimated glomerulofiltration rate (EGFR) 10. She was subsequently admitted for a transfusion of packed red blood cells with continued monitoring with complete blood count. She underwent a gastrointestinal bleed work-up and management of acute kidney injury. The patient's prior nephrology evaluation noted an acute kidney injury with prerenal azotemia due to severe anemia and gastrointestinal bleeding. She had chronic kidney disease stage (IV) with secondary hyperparathyroidism, hyperuricemia, diabetic neuropathy, type 2 diabetes mellitus, hypertension, hyperlipidemia, and obesity.

The healthcare plan acted reasonably and with some medical judgment and in the best interest of the patient but should have taken into consideration that there were life-threatening issues that needed to be addressed at an inpatient level of care until the patient stabilized.

According to the Milliman Care Guidelines, a clinical indication for admission to inpatient care for a patient with lower gastrointestinal bleeding includes anemia with exertional dyspnea, which was noted at the time of presentation to the emergency department. Given the patient's comorbidities, inpatient care for the first four days was reasonable given that it was determined that the patient was critically ill with a high probability of imminent or life-threatening deterioration.  The patient had stabilized with a hemoglobin level at 8.7 posttransfusion. Therefore, the prior determination is partially overturned.

The insurer's denial of coverage for a full hospital admission is modified.