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

Diagnosis: Chronic low back pain

Treatment: intraosseous basivertebral nerve ablation, procedure code 64628

The insurer denied coverage for intraosseous basivertebral nerve ablation, procedure code 64628

The denial is upheld 

Reviewer #2:

In assessing whether intraosseous basivertebral nerve ablation using the Intracept device is considered more beneficial for this patient than standard treatments or procedures, it is important to know that the publications in peer-reviewed literature to date have been mostly company sponsored, have had methodologic flaws, and were at risk for confirmation bias. UpToDate does not support the use of radiofrequency ablation for low back pain. Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria.

For individuals who have vertebrogenic low back pain who receive ablation of basivertebral nerves, the evidence includes two randomized controlled trials (RCTs) (SMART and INTRACEPT trials, both sponsored by device manufacturer Relievant Medsystems, Inc.). Relevant outcomes were symptoms, functional outcomes, quality of life and treatment-related morbidity. In one RCT, at 12 months, 73% of patients crossed over to the active treatment group and therefore long-term comparative data is not available. Limitations to the other RCT include lack of a sham control and short duration of follow-up.

This patient is not a good candidate for intraosseous basivertebral nerve ablation based on clinical evidence of other pain etiology, such as facet arthrosis. Clinic notes state that the patient has posterior column back pain symptoms consistent with facet joint pain that is worse with standing and walking. In addition to Modic changes at L (lumbar) 5, the magnetic resonance imaging (MRI) also states evidence of bilateral facet arthrosis from L1 to S (sacral) 1. 

There are other evidence-based medications and treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. Any invasive procedure has risk of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

In summary, the supporting publications to date have been mostly company sponsored, have had methodologic flaws, and were at risk for confirmation bias. UpToDate does not support the use of radiofrequency ablation for low back pain. Despite FDA approval, Centers for Medicare and Medicaid Services (CMS) guidelines limit the use of basivertebral nerve ablation to a very select group of patients who do not have evidence of other pain etiology such as lumbar facet arthrosis. The Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient. The denial is upheld.

In summary, the denial of intraosseous basivertebral nerve ablation, procedure code 64628 and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain

Treatment: intraosseous basivertebral nerve ablation, procedure code 64628

The insurer denied coverage for intraosseous basivertebral nerve ablation, procedure code 64628

The denial is upheld 

Reviewer #1:

This patient has chronic low back pain (CLBP). The patient has tried acupuncture, massage therapy and physical therapy. The patient's current pain medication is Tramadol. The patient's magnetic resonance imaging (MRI) shows Modic changes at L (lumbar) 5 - S (sacral) 1. It also shows degenerative disc disease with foraminal stenosis. The request is for radiofrequency ablation (RFA) of the basivertebral nerves (BVN) at L5 and S1.	

In 2018, Fischgrund and colleagues (1) published a double-blind, sham-controlled randomized controlled trial (RCT) evaluating the Intracept system and radiofrequency (RF) ablation of the Basivertebral nerve for the treatment of chronic low back pain. A total of 225 participants with chronic (>= 6 months) isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham (n=78) or treatment (n=147) intervention. In the active treatment group, the RF probe was activated and the temperature at the tip was maintained at 85Celsius for 15 minutes. The duration of the session in the sham group was the same but the RF treatment was only simulated. Study participants had a minimum Oswestry disability index (ODI) of 30 points (on 100 point scale) and a minimum visual analog scale (VAS) of 4 centimeters (cm) (10 cm scale). The primary efficacy endpoint was the comparative change in ODI from baseline to 3 months. Both intention-to-treat (ITT) and per protocol (PP) analysis were pre-planned. A total of 19 of 147 (13%) participants in the treatment group were excluded from the PP analysis; 16 for a targeting failure, 1 for procedural failure and 2 for protocol non-compliance. One participant in the sham group was excluded from the PP analysis and this was for protocol non-compliance.

Urits et al (5) also commented on the need for more research on this promising technique:  "reproducible large RCTs are still needed for clinicians to gain full confidence in utilizing this treatment in practice. Additionally, further research is needed on the anatomy of the vertebrae to optimize the method of treatment. These studies can help to elucidate the role of RF ablation in the management of CLBP and improve the quality of life of CLBP patients in the near future."

In sum, this procedure is NOT likely to be more beneficial than the standard of care.

In summary, the denial of intraosseous basivertebral nerve ablation, procedure code 64628 and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Migraines
Treatment: Aimovig 70 mg auto injector, via subcutaneous injection, quantity for 30 days
The insurer denied: Aimovig 70 mg auto injector, via subcutaneous injection, quantity for 30 days
The denial is overturned.

The patient is a teenage male with migraines. His migraines had increased in frequency during a clinic visit on 10 months ago. He had eight bad migraines in three to four weeks. He was taking topiramate at that time. The plan at that visit was to increase topiramate to 50 milligrams (mg) at bedtime. There are instructions, but no clinical notes detailing the updated history, from an office visit dated 3 months ago. The instructions state to continue topiramate at 50 milligrams at bedtime to prevent migraines and to start Aimovig (erenumab-aooe) 70 milligrams monthly for improved migraine prevention. The plan denied the request due to not meeting policy criteria of a minimum of 18 years of age for Aimovig use. This was appealed by the treating physician with a letter stating the patient has tried and failed topiramate and amitriptyline but continues having frequent migraines. The letter states Aimovig and other calcitonin gene-related peptide (CGRP) inhibitors are safe and effective in adolescents. In addition, the published consensus of pediatric migraine specialists is to use calcitonin gene-related peptide inhibitors in patients who failed other preventative medications. 
This review is in regard to Aimovig use.

The requested health service is medically necessary.

The patient has migraines and requires improved prevention of migraine headaches. The patient has tried and failed two first-line migraine preventive treatment options for his age. There is some efficacy and safety data for calcitonin gene-related peptide (CGRP) inhibitors in the patient's age group. There is a retrospective study of calcitonin gene-related peptide inhibitors used for prevention of migraine in adolescent patients that showed an improvement in the number of headache days and functioning compared to their baseline (1). Another retrospective 
study specific to Vyepti (eptinezumab) showed a reduction in headaches and good tolerability in 11 patients (2). Vyepti is analogous to the other calcitonin gene-related peptide monoclonal antibodies medications, including Aimovig, so the results are pertinent. This patient has special circumstances for which calcitonin gene-related peptide inhibitors would be appropriate as the patient is an adolescent who has failed 2 first-line treatments to prevent migraines and continues needing improvement in migraine frequency. The patient should be considered as having special circumstances where calcitonin gene-related peptide inhibitors could be considered (3). Therefore, calcitonin gene-related peptide inhibitor use is supported in this specific case based on current medical literature. Aimovig is medically necessary per current standards of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest pain
Treatment: Inpatient admission
The insurer denied coverage for: Inpatient admission
The denial is: Upheld
This is a case of an adult with a history of hypertension, paroxysmal atrial fibrillation and ischemic heart disease that presented to the Emergency Department (ED) complaining of chest pain for several weeks. Physical examination upon arrival was benign and no abnormalities were reported.  Blood Pressure (BP) was 166/86 millimeters of mercury (mmHg) and pulse was 97 beats per minute (bpm).  Vital signs remained stable throughout the patient's hospitalization.  Electrocardiogram (ECG) revealed normal sinus rhythm without evidence of ischemic abnormality. Serum blood testing demonstrated no elevation in high sensitivity troponin (8 nanograms per liter (ng/L). The patient was admitted to the hospital for monitoring and treatment. Echocardiogram demonstrated a left ventricular ejection fraction (LVEF) of 51%. Ultimately the patient was released on medical therapy.

Full hospital admission was not necessary for this patient that presented with chest pain. The patient's pretest probability of coronary artery disease is intermediate. (Reference 1) Utilizing the History, electrocardiogram, age, risk factor, and troponin (HEART) score he was considered intermediate risk. (Reference 2) Risk assessment of patients presenting with chest pain and no significant ST changes on ECG was reviewed by Hedayati et al. (Reference 3). Using the HEART score risk stratification schema, this patient would have an intermediate risk of major adverse cardiac events (defined as myocardial infarction (MI), need for percutaneous coronary intervention (PCI), need for coronary artery bypass grafting (CABG), or death) in the six weeks following presentation. These findings are concerning and warrant management and evaluation that includes serial troponin measurement, echocardiography and ischemia work-up prior to discharge. However, numerous studies have demonstrated that work-up can be performed in an observation unit without the need for hospital admission. Several investigators studied patients presenting to the hospital with chest pain and compared outcomes between those admitted to the hospital for short stay admissions and those that were placed in an observation unit at a lower level of care. (References 4,5) They found no significant difference in outcome at 30 days between the two groups.  Fernando Bellolio et al. noted that patients presenting with chest pain, that were managed in an observation unit, had similar 30-day myocardial infarction rates as those admitted to the hospital. (Reference 5) Admission to the hospital to treat an acute cardiac event was not medically necessary. In conclusion, this patient could have been managed at a lower level of care.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for inpatient admission is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal Pain
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is upheld.

This patient is a teenage male with no past medical history who presented to the emergency room for vomiting and abdominal pain. On exam, the patient was ill and diaphoretic. Abdominal exam showed decreased bowel sounds, right upper quadrant (RUQ) tenderness, right lower quadrant (RLQ) tenderness, and guarding of the abdomen. Lab studies showed a sodium of 132, alkaline phosphatase of 378, C-reactive protein (CRP) of 12.9, white blood cell (WBC) count of 12.7, and hemoglobin of 11.2. Computed tomography (CT) of the abdomen showed no evidence of appendicitis. The patient was admitted and received Zofran 4 milligrams intramuscular, normal saline (NS) 1000 milliliters (mL) intravenous, and morphine 4 milligrams intravenous. The patient was admitted due to failure to respond and concern for appendicitis.

The requested health service was not medically necessary.

An inpatient level of stay was not medically necessary since the patient did not require any procedural or surgical intervention, did not require to be nothing by mouth for a prolonged duration of time, did not require prolonged treatment with intravenous hydration or intravenous medications, did not have acute kidney injury, did not have electrolyte derangement needing intravenous replacement, and/or did not have any complications such as intra-abdominal abscess or a surgical abdomen. The patient also did not have hemodynamic instability, did not have severe pain requiring acute inpatient management, and did not have peritoneal signs. The patient did not require identification of etiology or finding or evaluation requiring the patient to not eat or drink for an extended period. Therefore, the requested health service was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: pneumonia
Treatment: inpatient stay
The insurer denied an inpatient stay
The health plan's determination is upheld. 

The patient is a female who initially presented to the emergency department with concerns for cough and shortness of breath. Pertinent history included prior tobacco use, heroin use on methadone, and psychiatric issues. Initial vital signs revealed a temperature of 99.1o (degrees) F (Fahrenheit), (heart rate (HR) 86, blood pressure (BP) 118/80, respiratory rate (RR) 18, and peripheral capillary oxygen saturation (SpO2) 95% (percent) on room air. Initial examination documented the patient as alert and oriented. Initial laboratory testing revealed a white blood cell count (WBC) 17.1, Hemoglobin (HGB) 10.7, platelets (Plt) 232, blood urea nitrogen (BUN) 11, Cr (creatinine) 0.5, carbon dioxide (CO2) 25, and K (potassium) 4.0. Chest radiograph revealed findings suggestive of bilateral infiltrates. Repeat SpO2 was 92-93%. Empiric ceftriaxone and azithromycin were initiated. The patient was placed in the hospital thereafter with an impression of pneumonia of both lungs due to infectious organism.

The inpatient hospital admission was not medically necessary.
The patient initially presented with concerns for cough and shortness of breath. Initial examination documented the patient as alert, oriented, afebrile, hemodynamically stable, and without hypoxia. Initial laboratory testing revealed a leukocytosis with a BUN 11 and Cr 0.5. Chest radiograph revealed findings suggestive of bilateral pneumonia. Empiric antibiotics were initiated. The admitting physician documented an SpO2 96% on room air, CURB-65 of 0, and PSI of class 1. Following observation care, the patient remained afebrile, hemodynamically stable, and without hypoxia. No other issues or complications were documented.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Asthma

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission

The denial is upheld

The patient has a history of viral syndrome, hypertension (HTN), and asthma.  The patient presented to the emergency department (ED) with complaints of shortness of breath and cough for approximately 2 weeks.  Vital signs on presentation were: Temperature 98.6 Fahrenheit, heart rate 89, blood pressure (BP) 160/98, respiratory rate (RR) 23, and oxygen saturation 100% on room air.  The patients peak expiratory flow (PEF) was 200.  The patient was in no acute distress.  The patient was alert and oriented x3.  Lung sounds revealed some wheezing.  Heart sounds were normal is S1 and S2.  The patient's abdomen was soft and non-tender.  The patient's white blood cell count (WBC) was 9.3, venous blood gas was 7.38/45/72, and lactate was 1.6.

The patient was treated with intravenous (IV) steroids, bronchodilators (BD) via nebulizer, magnesium, and phosphorus.  A chest x-ray (CXR) showed no acute infiltrates.  The patient improved with treatment and was discharged in a few days.  

This patient did not need acute inpatient hospitalization.  The patient could have been placed in observation status while diagnostic testing and treatment could have been initiated.  Observation could be for up to 48 hours.  This patient was afebrile and hemodynamically stable, was not hypoxic, and there was no pneumonia (PNA) or pneumothorax on imaging.  The patient could have been discharged home on oral steroids and bronchodilators after a period under observation with close follow-up as an outpatient.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Inpatient Admission is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Obesity
Treatment: Wegovy
The insurer denied the request for Wegovy.
The health plan's determination is upheld. 

The patient is a female with a past medical history of morbid obesity, prediabetes, mixed hyperlipidemia, ex-smoker, anxiety, and depression who had been working with her medical provider for years to treat her obesity.

Wegovy is not medically necessary for this patient.

Based on the documentation provided, the patient is not and has not recently been in a comprehensive weight management program that encourages behavioral modification, reduced calorie diet, and increased physical activity with continuing follow-up for at least 6 months prior to using drug therapy. The current literature recommends medication therapy after the patient has failed diet, exercise, and behavioral modification and once the medication is started the patient continue with a comprehensive weight management program. At this time, Wegovy is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Lower back pain s/p drainage/culture
Treatment: Inpatient admission
The insurer denied coverage for: Inpatient admission
The denial is: Upheld
Patient is an adult with a past medical history significant for chronic lower back pain, hemoglobin sickle C (SC), status-post (s/p) gastric sleeve, and Cesarean section who presented to the Emergency Department (ED) with complaints of lower back pain. 

Vital signs on presentation included: Temperature (T) 98.4 Fahrenheit (F), Blood Pressure (BP) -164/94, Pulse (P) -85, Respiratory Rate -18, oxygen (O2) saturation (sat) -99% on room air (RA). Laboratory values were notable for: white blood cell count (WBC) -7.1k, hemoglobin (Hgb) -9.1, hematocrit (Hct) -29.7, creatinine-0.6, glucose-85.

The patient was empirically started in intravenous (IV) antibiotics (Clindamycin, switched to Ceftriaxone and Doxycycline) for left thigh cellulitis. Computed tomography (CT) scan of abdomen/pelvis showed 2.9 x 1.5 centimeter (cm) hypoattenuating collection involving right inferior rectus abdominal muscle and perhaps a small rectus sheath hemorrhage. Ultrasound showed small seroma or old hematoma. The patient was treated with intravenous antibiotics and underwent an Interventional Radiology (IR)-guided drainage and culture was sent. Patient remained afebrile, hemodynamically stable and clinically improved. The patient was discharged on oral antibiotics (Doxycycline and Keflex).  

According to documentation, the patient presented with abdominal pain. Otherwise, was afebrile and hemodynamically stable. Laboratory results were unremarkable including a normal white blood cell count (WBC). The patient had no evidence of a disseminated infection. IR guided drainage showed collection was non-infectious (cultures negative). Based on above findings, patient met criteria for observation level of management.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Inpatient Admission is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hypoglycemia

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission

The denial is overturned

The patient is diagnosed with prediabetes who presented to the emergency room (ER) with generalized malaise. Pertinent past medical history (PMH) and/or past surgical history (PSH) included atrial tachycardia (to 160), prediabetes, leukopenia, non-ischemic cardiomyopathy (NICM). The request is for coverage of hospital stay.

The patient has a history of similar episodes during the past year.

Upon examination, the patient was diagnosed with hypoglycemia and had light headedness, dizziness and feeling faint, nausea, persistent tremors since the day before. Finger stick at home was 58.  Vital signs were: blood pressure (BP) 109/79, heart rate (HR 90), temperature (T) 97.9F (Degrees Fahrenheit), and carbon dioxide (PCO2) 59.  An electrocardiogram (EKG) showed a heart rate of 61 and QTc 384.

In the ER, the patient's sugar ranged from 86 to 79, but it had occurred after some hours of fasting.

On the following day, labs revealed: Venous PH 7.36, PCO2 59, oxygen (PO2) 21, bicarbonate (HCO3) 33, total carbon dioxide 35, Potassium 4.8, Sodium 135, Lactate 1.3, white blood cell count (WBC) 2.76, Anion gap 10, blood urea nitrogen (BUN) 20, and creatinine 1.22.

Additional labs included: thyroid stimulating hormone (TSH) 1.1, C-peptide 4.1, and Beta hydroxyl butyrate 0.1

Finally, additional labs included: WBC 2.76, Sodium 140, Potassium 3.9, serum carbon dioxide 24, Anion gap 15, BUN 16, Creatinine 1.14, Glucose 78, estimate glomerular filtration rate (eGFR) 80.  Hemoglobin A1C estimated average 6 percent (%), estimated average glucose 126. After more than 48 hours, there were no episodes of hypoglycemia. 

The diagnosis of the cause of hypoglycemia in patients who are not on hypoglycemic agents requires a 72 hour fasting study to induce hypoglycemia and draw a critical sample to determine the cause of hypoglycemia (1-4). The patient had documented hypoglycemia without being on any hypoglycemic agents. The patient was admitted for a 72 hour fasting study. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for an inpatient hospital admission is substantiated.