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

Diagnosis: Infectious disease /Hepatitis 
Treatment: Pharmacy prescription drugs 
The insurer denied Vemlidy 25MG OR TABS
The denial is upheld in whole

The patient  with chronic hepatitis B virus (HBV) infection which has resulted in cirrhosis, portal hypertension, and esophageal varices.

Tenofovir alafenamide (TAF) (trade name -Vemlidy) has recently been FDA-approved for chronic HBV infection. TAF is a drug modified from an existing FDA-approved drug for chronic HBV infection, tenofovir disoproxil fumarate (TDF). TAF is more stable in the plasma and can provide similar efficacy with lower circulating drug concentration in patients with HBV infection. TDF has been linked to kidney and bone toxicity in some patients. In phase 3 registration trials, TAF was not inferior to TDF in antiviral efficacy for both HBeAg-positive and HBeAg-negative patients, while associated with less reduction in the estimated glomerular filtration rate and bone mineral density. Current HBV treatment guidelines and existing data supports the use of TAF as one of the first-line antiviral agents for patients with chronic HBV infection without hepatic decompensation. However, more real-world data with long-term observation are needed to better define the role of TAF compared to other oral anti-HBV regimens. Additional studies are also needed to evaluate the efficacy and safety of TAF in special populations such as those with impaired hepatic function, existing impaired renal and/or bone function, and in pregnant women.

Based on the materials provided and the current medical literature, TAF (Vemlidy) is an appropriate agent for this patient but alternative agents, including TDF, could also be appropriate and efficacious. There are multiple FDA-approved agents to treat chronic HBV infection but there is no current data which would suggest TAF (Vemelidy) is more efficacious than other FDA-approved agents. It is not medically necessary for TAF Vemelidy to be the preferred agent for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Stage IV breast cancer with brain metastasis.
Treatment: IGRT (Image-Guided Radiation Therapy).
The insurer denied the IGRT (Image-Guided Radiation Therapy). 
The denial is overturned. 

The patient is a female with stage IV breast cancer with brain metastasis.  Palliative whole brain radiation therapy with three-dimensional (3D) conformal radiation therapy was recommended and image-guided radiation therapy (IGRT) was requested for approval.  The health plan approved the radiation therapy but has denied the IGRT.

Yes, the proposed IGRT is medically necessary.

Image guided radiotherapy (IGRT) is a method of tumor localization during the delivery of radiation therapy.  This procedure is performed during the actual radiation therapy delivery session.  It is a technique used to compensate for the movement of the tumor and/or patient during radiation therapy.  It provides accurate and objective monitoring of the patient's alignment and motion as well as the tumor's position.  The information from IGRT is used to adjust the patient's position for optimal radiation dosing to the target area while sparing adjacent healthy tissue or organs.  IGRT is typically used in patients with tumors located near or within critical structures and/or in tissues with setup variations.  IGRT is an FDA approved procedure and it is not subject to institutional review board (IRB) review.

Palliative whole brain radiation therapy with 3D conformal radiation therapy was recommended and IGRT was requested for approval.  Typically, palliative whole brain radiation requires conventional conformal radiation therapy; routine port films are also needed for target localization and quality assurance.  In this case, per the provider, "given her history of brain metastases and a difficult social situation patient is unwilling to drive to any other facilities for treatment.  My facility is the closest to her house As such, she does not have the option or capability to receive treatment at a facility that does not use a TomoTherapy machine."  The facility only has a TomoTherapy unit, which does not have the capability of taking port films.  For target localization and verification, the TomoTherapy unit uses image-guided radiation therapy (IGRT) with megavoltage computed tomography (CT) imaging.  Since target localization and verification is a crucial procedure for radiation therapy, and that IGRT is the only way for the TomoTherapy unit can perform this task, IGRT is medically necessary for this patient at this time.
Appeal type: Medical necessity
Decision: Overturned

Respiratory System
Inpatient Hospital

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

This is a male with no significant past medical history who presented to the emergency department (ED) with persistent fever and cough for the past 2 days. He was well until 2 days prior when he started to develop fever of 101-102 and persistent productive cough. The fever has been treated with Tylenol and Motrin but have not helped. The patient produced sputum that was described as yellowish clump. In addition, the patient reported night sweats that started 2 nights prior. He reports 2 days of decreased by mouth (PO) intake. In the ED, the patient was noted to be febrile to 102.7 with blood pressure (BP) 106/50, heart rate (HR) 132, respiratory rate (RR) 26, and O2 sat 95%. The patient met sepsis criteria per ED notes. 

The Inpatient Hospital Admission was medically necessary for this patient. This patient presented with history of fever and cough and was confirmed to be Influenza A positive. He was found to have hypotension and tachycardia in the ED. His tachycardia may have been a result of his febrile state, but his wide pulse pressure and episodic hypotension were concerning. He was treated with multiple normal saline boluses totaling 4 L over the course of 5 hours and his symptoms persisted. Although the list of differential diagnoses for wide pulse pressure is long, of greatest concern is impending sepsis with hyperdynamic circulation and severe vasodilation. Associated with his aberrant blood pressure readings he also complained of dizziness and lightheadedness. Given his diagnosis of Influenza A, there is also risk of secondary bacterial infection, possible toxic shock from such infection as well as central nervous system (CNS) complications including aseptic meningitis, acute cerebellar ataxia, Guillain-Barre or transverse myelitis. Admission to inpatient level of care for cardiac monitoring, cardiac consult and IV antibiotics with close monitoring pending cultures would be prudent and in the best interest of this patient. Although he responded well to treatment and was discharged within 48 hours, at the time of admission, the ED physician would not be able to determine such an outcome based on his findings in the ED. He was treated in the ED and given adequate time as well as proper interventions without recovery. For these reasons, the inpatient level of care was medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Digestive System/ Gastrointestinal.
Denial: Inpatient stay.
The health plan's determination is upheld in whole.

The patient has a medical history of spinal stenosis, chronic constipation, hypothyroidism, and open umbilical hernia repair with mesh who presented to the emergency department  with abdominal pain for several months and nausea. Patient reported two days of severe periumbilical stabbing abdominal pain, loss of appetite, chills, anorexia, diarrhea, nausea, vomiting, and a gait problem. Vital signs were notable for tachycardia with pulse rate of 101/minute. Examination was notable for an ill appearance, periumbilical abdominal tenderness, and abnormal gait. Labs showed elevated blood urea nitrogen of 22 mg/dL. Computed tomography scan of the abdomen and pelvis showed partial/low-grade small bowel obstruction, small bowel wall thickening involving the dilated segments representing inflammation/enteritis, and less likely ischemia. patient  was made nil per os and was treated with intravenous fluids and morphine. Surgery consultation noted that there was likely enteritis, lack of obstruction, and no indication for surgical admission or intervention. Gastrointestinal pathogen panel was negative. Patient  felt better, with improving abdominal pain and lack of nausea and vomiting;  was tolerating clear liquids. Labs showed low hemoglobin of 11.1 g/dL. On day of discharge abdominal pain had resolved, patient  had one bowel movement;  denied nausea and vomiting, and was asking to advance the 
diet. 

The inpatient level of care is not supported in this case. The patient presented with abdominal pain, nausea, and vomiting consistent with gastroenteritis or bowel obstruction, and imaging consistent with partial small bowel obstruction. The standard of care for uncomplicated partial small bowel obstruction, including intravenous fluids, serial abdominal exams, nil per os status with gradual advancement of diet, and monitoring of labs was performed, and all could have been performed without the inpatient level of care [1-3]. The standard of care for the treatment of gastroenteritis was also appropriately performed, including intravenous fluids and supportive care, and symptoms improved [4-6]. There was no protracted fever or hypotension to suggest uncontrolled infection. No other cause for the inpatient level of care, such as peritonitis, abscess, perforation, fistula, toxic megacolon, sepsis, or other complication was documented. Observation, monitoring, labs, and specialist consultation could have been performed without the inpatient level of care, at a lower level of care. For these reasons, the inpatient level of care is not supported in this case.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Chron's disease.
Treatment: Formulary exception request for Pentasa 500mg.
The insurer denied the Formulary exception request for Pentasa 500mg. 
The denial is overturned. 

The patient is a female with small bowel Crohn's. She has failed treatment with Apriso, Lialda, Sulfasalazine and Balsalazide. The attending physician (AP) is requesting treatment with Pentasa.

The patient has small bowel Crohn's and has failed Apriso and Lialda (mesalamine 1200). Medical literature supports that Pentasa is pH dependent and is therefore released more in the small bowel than mesalamine 400 or mesalamine 800, the two preferred formulary agents that the patient has not tried.   As Pentasa is more effective than those agents for the treatment of small bowel Crohn's disease, this patient's condition, the health plan should cover the proposed treatment with Pentasa.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cancer/pancreas cancer
Treatment: Radiation therapy
The insurer denied the Image guided radiation therapy(IGRT), Intensity-Modulated Radiation Therapy treatment procedure 
The denial is overturned 

This is a patient with a stage IIB pancreatic adenocarcinoma status post Whipple resection with positive margins and 12 cycles of adjuvant chemotherapy. Radiation therapy with concurrent chemotherapy is recommended to decrease the risk of local recurrence.
Yes, the requested treatment of Image guided radiation with IMRT treatment procedure is considered medically necessary for this patient.
This patient has a local regional pancreatic adenocarcinoma with no evidence of distant metastases. He has an increased risk of recurrence where radiation therapy with concurrent chemotherapy has been shown to decrease this risk of recurrence significantly. The recommended IMRT with image guidance is considered medically appropriate and necessary. According to the physician documentation, a 3D conformal radiation plan has been produced which was not safe for this patient as the small bowel dosing was unacceptable and too high of risk of side effects. An IMRT plan was also produced for this patient and showed this type of radiation approach can significantly spare the small bowel from receiving high doses of radiation and in turn decrease the risk of side effects for this patient. The recommended IMRT with image guidance is medically necessary for this patient and his clinical scenario.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Multiple Sclerosis.
Treatment: Mavenclad 10mg tablet.
The insurer denied Mavenclad 10mg tablet. 
The health plan's determination is upheld.

The patient is a male diagnosed with multiple sclerosis (MS) five years previously with paresthesias on the left side of the face and head. He was found to have lesions in the medulla, and cervical and thoracic spines. He had a previous history of optic neuritis. He was subsequently diagnosed with multiple sclerosis and was considered for a disease-modifying therapy, but not treated. 

All of the available medications are known to be effective in treating multiple sclerosis. While all medications have adverse effects, there is no evidence that Mavenclad has a superior adverse effect profile than all of the available formulary medications.

Firdapse is not FDA-approved or evidence-based to treat multiple sclerosis. Zinbryta is a multiple sclerosis disease-modifying medication that was removed from the market in 2018 and is not available. However, there is no evidence that all of the other available formulary medications would be ineffective. There is no evidence in the medical literature that Mavenclad is superior in efficacy to all of the available formulary disease-modifying medications as Mavenclad has not been evaluated in randomized trials with all of the available formulary medications.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Congenital Vascular Malformation 
Treatment: Sirolimus Compound 

The insurer denied Sirolimus Compound. The denial was overturned. 

This is a male patient with a rare congenital vascular malformation associated with lymphatic fluid leakage and bleeding. This malformation was recurrent superficially causing an effect on his activities and causing the patient pain. The patient's provider is requesting insurance coverage for Sirolimus Compound for topical treatment for this patient. 

As Garcia-Montero, et al. (2019) in as study with average age 10.5 years, "Treatment with topical rapamycin modifies the clinical appearance and alleviates symptoms of superficial [lymphatic malformations (LM)]." And as per Wataya-Kaneda, et al. (2017), "Topical sirolimus gel is safe and effective for facial angiofibromas in TSC. The optimal concentration of sirolimus was 0.2%." This study involved adults. Up to Date in their discussion of management of microcystic lymphatic malformations note the success with use of sirolimus. 

Based on the review of the medical record and literature, Sirolimus Compound is considered medically necessary for this patient. These rare lymphatic vascular malformations can be debilitating, painful, recurrent and challenging to treat. Treatments include laser therapy, intra-lesional bleomycin, and surgical intervention. Therefore, this topical compound is medically necessary. 

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

Based on the above, the medical necessity for Sirolimus Compound is substantiated.  The insurer's denial should be overturned.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Small Bowel Obstruction.
Treatment: Interfacility Transfer via ambulance service.
The insurer is denied coverage for interfacility transfer via ambulance service.
The denial is upheld. 
This is a female patient with a past medical history of atrial septal defect status-post surgical repair, pulmonary hypertension, gastroesophageal reflux disease, chronic anemia, Ehlers-Danlos syndrome, motility disorder, recurrent small bowel obstruction with intussusception, status post 2 lysis of adhesions, ileus, status post Nissen fundoplication converted to toupee with pyloroplasty and further revision, subsequent gastroparesis and status post gastrostomy (G) tube placement and removal. The patient was transferred to another medical facility for further care. Diagnostic imaging from the prior hospital did not show small bowel obstruction. The patient was medically managed but did not receive a nasogastric tube due to a concern for perforation. 

To render a decision requires knowing the clinical status of the patient at the initial hospital. As noted, no records from the initial hospitalization were provided despite attempts to obtain those records. As per CMS regarding ambulance transfer "Medical necessity is established when the patient's condition is such that use of any other method of transportation is contraindicated. In any case in which some means of transportation other than an ambulance could be used without endangering the individual's health, whether or not such other transportation is actually available, no payment may be made for ambulance services." Thus, since the patient's clinical situation at the time of transfer is unknown, the use of ambulance transfer cannot be supported regardless of the destination.

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

The carrier's denial of coverage for the interfacility transfer via ambulance service for inpatient admission should be upheld.  The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Digestive System/Gastrointestinal.
Inpatient Hospital.
Diagnosis:  Appendicitis.
Treatment Inpatient Hospital Stay.
The insurer denied the Inpatient Hospital Stay.
The determination is upheld.

The patient who presented to the emergency department (ED) on with a history of progressively worsening abdominal pain of 1-day duration. Evaluation included a physical exam, labs, a pelvic and right lower abdominal ultrasound. She was without a fever at the time of presentation. Vital signs were normal. Lab data identified a white blood cell (WBC) count of 11.9 thousand (K). An ultrasound scan yielded the diagnosis of acute appendicitis. Treatment was initiated with intravenous (IV) fluid and antibiotics. A surgical consultation was obtained.
The patient underwent a laparoscopic appendectomy for the diagnosis of acute appendicitis. The clinical notes and the anesthetic record indicate an uncomplicated appendectomy. The operative note describes an acute, non-perforated, appendicitis. She was provided IV fluid and perioperative antibiotics. Vital signs remained normal following ED presentation. She tolerated a diet following surgery and was discharged from the hospital  from the post-anesthesia care unit.
At issue is the medical necessity of an inpatient stay.
The inpatient care was not medically necessary in this case. The records indicate that this patient presented to the ED with acute appendicitis on and underwent an appendectomy.
The pre and post-surgical course was uncomplicated. Her vital signs remained normal. Her diet progression was tolerated following surgery. She was discharged home from the post-anesthesia care unit (PACU) following surgery. The records support that this patient could have reasonably and appropriately been treated at a lower level of care, which would have permitted pre-surgical assessment, operative treatment, post-surgical monitoring, diet progression, overnight care if needed, and provision of perioperative antibiotics.
The records document that this patient was clinically and hemodynamically stable at the time of presentation. Surgery was performed and the perioperative period was uncomplicated. While this patient did need urgent surgery she did not require inpatient admission. Inpatient stay may be needed for failure to achieve discharge status criteria, conversion to open surgery, systemic infection, care for active comorbidities, complications of procedure. In this case none of these conditions existed to warrant an inpatient level of care.
Inpatient care is indicated when there is toxicity, active comorbidities or there is inability to arrange outpatient support. Inpatient admission is also indicated for complicated appendicitis, complications of the procedure, ileus or post-operative bleeding, or other condition that requires inpatient admission. In this case, none of these indications existed to justify an inpatient level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Acute Coronary Syndrome.

Treatment: Inpatient Admission.

The insurer denied the inpatient admission.

The denial was upheld.

This is a female patient with a medical history of hypertension, diabetes, hyperlipidemia, and hypothyroidism. The patient presented to the Emergency Department (ED) with weakness, nausea, and vomiting for several days. She denied any shortness of breath and chest pain but did complain of generalized body aches. In the ED, the patient's vitals were: temperature 98.5, blood pressure 120/60, heart rate 81, respiratory rate 18, and SpO2 100% on 2L/min via nasal cannula. A physical exam was performed with normal findings. The patient's initial lab results showed elevated troponin of 26 and creatinine of 1.80; a repeat troponin level drawn with results of 23. There is a single lab report for TnT of 24 on the 14th. The proBNP was normal. An electrocardiogram (EKG) was done that was interpreted as normal. It was later reported that her EKG had non-specific T changes. A chest x-ray was done and reported as clear. A urinalysis (UA) was obtained that was negative for blood, protein 200, nitrite positive, leukocyte esterase large, WBC >50 and many bacteria. She was admitted to telemetry for acute cystitis and to rule out acute coronary syndrome. The patient's hospital course of treatment and management included intravenous (IV) fluids, IV Ceftriaxone, Meclizine, cardiac monitoring, aspirin, atorvastatin, labetalol, clonidine, hydralazine, and blood sugar monitoring with insulin sliding scale. The patients was medically stabilized and discharged home with follow-up instructions.                 

Based on the review of the medical record, the patient presented with non-cardiac symptoms, either normal or nonspecific T changes on ECG and TnT levels that were not consistent with an ischemic event.  There was no evidence to support ACS.  Inpatient admission was not medically necessary for this patient. The patient's care could have been provided in the observational setting, allowing for additional diagnostic testing. Treatment of cystitis is done as an OP. There was no evidence of either hyperosmolar or diabetic ketoacidosis. 

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

Based on the above, the medical necessity for the inpatient admission is not substantiated.  The insurer's denial is upheld.