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

Genitourinary/Kidney Disorder
Inpatient Hospital

Diagnosis: Chronic Kidney Disease
Treatment: Inpatient Stay
The insurer denied the inpatient stay.
The health plan's determination is upheld.

The patient is a male with nephrotic syndrome and chronic kidney disease who presented with two episodes of syncope and abdominal pain. He had Ofatumumab one week prior to his arrival to the emergency room (ER), but the infusion was terminated due to syncope. He had a normal electrocardiogram (ECG). He did have electrolyte anomalies, most notably a venous blood gas that demonstrated a potential hydrogen (pH) of 7.19 and a partial pressure of carbon dioxide (pCO2) of 56 and hypoglycemia to 55. He returned to the ER the following day and was noted to have pain and loss of consciousness. The venous blood gas (VBG) showed ongoing acidosis and cardiology was consulted and patient was placed on telemetry.

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

The requested service of an inpatient stay was not medically necessary. The patient did not require intravenous (IV) medication intervention for his metabolic acidosis and other testing could have been done as an outpatient. The patient required no pain medications that would require prescription or IV administration as part of the management of abdominal pain. Although the patient has a complex medical history there was no indications from the provider's documentation that the patient was unstable/unwell. Interventions did not warrant an inpatient level of care and there was no indication for the patient to receive Ofatumumab as part of the hospitalization for evaluation of a syncopal episode. Patients who have had a syncopal event from which they have completely recovered and have no red flags for cardiac syncope can be followed as outpatients.

The health plan's determination of medical necessity is upheld in whole.
Appeal type: Experimental/Investigational
Decision: Upheld

Cardiac/Circulatory Problems/Coronary Artery Disease/CAD
Surgical Services (All)/Intracardiac Ischemia Monitoring System
The health plan denied the requested treatment as experimental/investigational. The health plan's determination is upheld.

The patient is a male with a past medical history of essential hypertension. He presented to the hospital with a non-ST elevation myocardial infarction and his work-up demonstrated evidence of obstructive coronary artery disease. Subsequently, he underwent percutaneous coronary intervention (PCI) of his posterolateral artery. He has been followed by cardiology and underwent implantation of Ischemia Monitoring System with Monitor.

At issue is whether the proposed health service or treatment of insertion or replacement of  Intracardiac Ischemia Monitoring System with Monitor, Cardiac, including Intracardiac Lead and All System Components is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

I uphold, in whole, the health plan's determination regarding the proposed treatment.

This patient has a history of a non-ST elevation myocardial infarction in the setting of coronary artery disease. Standard treatment for patients with coronary disease and history of myocardial infarctions is revascularization as well as medical therapy with antiplatelet medications (i.e. aspirin) and statins. This is in addition to lifestyle modification factors. Implantation of Intracardiac Ischemia Monitoring System is not a part of standard therapy for coronary artery disease and there are no large randomized control trials that have demonstrated its efficacy in improving cardiovascular outcomes. Consequently, there is insufficient clinical data to support medical necessity for this device and therefore, this treatment is considered investigational.
Appeal type: Experimental/Investigational
Decision: Upheld

Cardiac/Circulatory Problems/Coronary Artery Disease/CAD
Surgical Services (All)/Intracardiac Ischemia Monitoring System
The health plan denied the requested treatment as experimental/investigational. The health plan's determination is upheld.

The patient is a man with a history of hypertension, hyperlipidemia, type 2 diabetes, left bundle branch block and coronary artery disease. He had a non-ST segment elevation myocardial infarction and underwent percutaneous coronary interventions for stenoses in the posterolateral and posterior descending coronary arteries. He underwent implantation of the AngelMed Guardian device.

At issue is whether the proposed health service or treatment of insertion or replacement of Intracardiac Ischemia Monitoring System with Monitor, Cardiac, Including Intracardiac Lead and All System Components likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

I uphold, the health plan's determination that this service, in this instance, was not medically necessary.

The AngelMed Guardian system is an implantable device designed to monitor intracardiac ST segment changes and alert the patient if there are early signs of acute coronary syndrome (ACS) or myocardial infarction. In the pivotal trial 907 patients underwent implantation of the device and were randomized to a treatment group (alarm on) and control group (alarm off). Inclusion criteria included patients who were within six months of a high-risk event or coronary artery bypass graft surgery and who met at least one of the following criteria: diabetes mellitus, renal insufficiency or TIMI (Thrombolysis in Myocardial Infarction) risk score of 3 or greater. Left bundle branch block was one of the major exclusion criteria. The trial did not meet the pre-specified efficacy endpoint which was a composite of cardiac or unexplained death, new Q-wave myocardial infarction or detection-to-presentation time more than two hours for a documented coronary occlusion event. There was no significant difference between the treatment and control groups. However, in an expanded analysis using data obtained after the randomized period, the results suggested that the device potentially may be beneficial in high-risk patients in identifying asymptomatic coronary events.

While the medical literature suggests that this device may be of benefit in selected high risk patients with coronary artery disease, more data are needed to confirm that is has a salutary effect on health outcomes. In addition, this patient has a chronic left bundle branch block. Since left bundle branch block (LBBB) is associated with significant ST segment changes, even in the absence of myocardial ischemia and acute infarction, patients with LBBB were excluded from the pivotal trial of the AngelMed Guardian system. Thus, there are insufficient data to conclude that the device would be beneficial in this particular patient.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Nasal obstruction. 
Treatment: VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall). 
The insurer denied coverage for VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall). 
The denial is overturned. 

According to the medical records, the patient has a history of nasal airway obstruction, nasal fracture, and obstructive sleep apnea (OSA). The patient presented to the Otolaryngologist's office for a follow up for nasal obstruction. The patient continued to have ongoing nasal obstruction. The patient was recently started on continuous positive airway pressure (CPAP) which he tolerated well. An intranasal examination revealed severe lateral nasal valve collapse internally and externally and 3+ hypertrophy of inferior turbinate bilaterally. The physician recommended the VivAer procedure. 

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes. 

The patient has demonstrated severe lateral nasal valve collapse internally and externally on examination.  There is no medical management for nasal valve collapse and the VivAer procedure is less invasive than surgical options to relieve nasal obstruction. 

VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall) has final approval from the appropriate regulatory bodies for this diagnosis. The VivAer was Food and Drug Administration (FDA) approved in 2020. 
VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall) is the best available treatment for this patient at this time. 
The adverse risks are not increased over standard treatment/services. 
The VivAer procedure is less invasive than surgical options to relieve nasal obstruction. 
The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient. 

The patient has demonstrated severe lateral nasal valve collapse internally and externally.  There is no medical management for nasal valve collapse and the VivAer procedure is less invasive than surgical options to relieve nasal obstruction. 

In summary, the denial of VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall) and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Nasal obstruction. 
Treatment: VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall). 
The insurer denied coverage for VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall). 
The denial is overturned. 

The patient is an adult with more than a 1 year history of nasal congestion and obstruction; prior medical therapy without improvement; history of obstructive sleep apnea; examination notes nasal valve collapse and inferior turbinate hypertrophy with positive Cottle maneuver; review is for VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation). 

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes. The requested service is not experimental/investigational. This patient has a diagnosis of obstructive sleep apnea, bilateral nasal congestion, turbinate hypertrophy, nasal valve stenosis, and positive Cottle maneuver. Based on the failed medical therapies and current exam findings the request for radiofrequency nasal valve repair is medically appropriate and supported by current peer reviewed literature. 

VivAer procedure repair of Nasal valve collapse with low energy temperature controlled remodeling (a procedure to treat nasal airway obstruction) does have final approval from the appropriate regulatory bodies for this diagnosis. 
Based on the submitted medical record, VivAer procedure repair of nasal valve collapse with low energy temperature controlled remodeling (a procedure to treat nasal airway obstruction) is the best available treatment for this patient at this time.   
Based on the submitted medical record, the adverse risks are not increased over standard treatment/services. 
Based on the submitted medical record, the requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient. 
In summary, the denial of VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall) and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Nasal obstruction. 
Treatment: VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall). 
The insurer denied coverage for VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall). 
The denial is overturned. 

The patient is an adult who presented with nasal obstruction. Medical management was trialed without lasting benefit for the patient. The patient's symptoms have been present for a significant period of time. The nasal examination revealed lateral wall collapse and hypertrophy of the inferior turbinates. The request of this review is to determine the medical necessity of VivAer for improvement of symptoms. 

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcomes. 

VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall) does have final approval from the appropriate regulatory bodies for this diagnosis. 

VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall) is the best available treatment for this patient at this time. 

The adverse risks are not increased over standard treatment/services.   

This service is likely to be more beneficial than any of the standard treatments/procedures for this patient. 

The patient has failed medical management. A surgery - such as functional rhinoplasty - has more risk of complication. This is an in-office procedure with medical literature that is supportive for its use. 

In summary, the denial of VivAer procedure (repair of nasal valve collapse with temperature controlled radiofrequency ablation to remodel the lateral nasal wall) and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Nausea and chest pain

Treatment: inpatient admission

The insurer denied coverage for inpatient admission

The denial is upheld 

The patient is an adult female with past medical history significant for hypertension, depression, and herpes who presented to the emergency room with complaints of nausea and chest pain. 

Vital signs on presentation included: Temperature 99.0 degree Fahrenheit, Blood Pressure 143/99 mm Hg, Pulse 80 beats per minute, Respiratory Rate 17 breaths per minute, oxygen (O2) saturation 99% on Room Air. Laboratory values were notable for the following: white blood cell count (WBC) 4.08, Hemoglobin (Hgb) 13.1, Hematocrit (Hct) 40.7, Creatinine 0.75, Glucose 95, Aspartate Transaminase (AST) 993, Alanine Transaminase (ALT) 924.

The patient was admitted for elevated liver transaminases. Computerized Tomography (CT) scan showed bilateral external iliac adenopathy, borderline enlarged inguinal nodes and small bilateral cystic kidney stones. She received Zofran for nausea and diet was advanced as tolerated. The patient remained afebrile and hemodynamically stable. She was discharged to continue outpatient management including referral to Gastroenterology. 

According to the medical records, the patient presented with nausea. Otherwise, the patient was afebrile, hemodynamically stable, laboratory results were normal except for non-specific elevated liver enzymes. The patient was able tolerate oral intake. Based on the above findings the 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 the inpatient hospital admission is not substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2:

Diagnosis: Low back pain

Treatment: procedure codes 64628 and 64629, intraosseous basivertebral nerve ablation

The insurer denied coverage for procedure codes 64628 and 64629, intraosseous basivertebral nerve ablation

The denial is upheld

This patient has a history of low back pain beginning over 1 year ago. She has had multiple treatments including activity modification; chiropractic care; heat/ice; home exercises; medication management. Medication trials have included: Cymbalta; Ibuprofen; and non-steroidal anti-inflammatory drugs (NSAIDs).  She had a magnetic resonance imaging (MRI) that demonstrated Modic changes at disc spaces lumbar (L)4; L5; sacral (S)1. The request is for radiofrequency ablation (RFA) of the basivertebral nerves at L4, L5 and S1.

In sum, the publications to date have been company sponsored and had methodology flaws.  
There is no published data on long term complication rates.  There are other evidence- based interventions available to this patient.  This procedure is unlikely to be more beneficial than the standard approaches.

Conger et al (3) pointed out that all of the major studies while supportive, have been funded by the company:

"There is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

Similarly, a clinical practice guideline (4) while favorable pointed out the limitations of the current literature:

Industry funding is a potential source of study bias for the available data reviewed.
Limited number of studies.
Short-term follow up for the majority of studied patients.
Unknown effect on the primary degenerative process

Urits et al (5) also commented on the need for more research on this promising technique:  "reproducible large randomized controlled trials (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 chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

This procedure is NOT likely to be more beneficial than the standard evidence-based therapies.

In summary, the denial of procedure codes 64628 and 64629, intraosseous basivertebral nerve ablation 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: Psoriasis and arthritis

Treatment: Stelara 90 milligrams (mg) / milliliter (ml)

The insurer denied coverage for Stelara 90 milligrams (mg) / milliliter (ml)

The denial is overturned



The patient is an adult female with a diagnosis of psoriasis and arthritis.  The patient has 10% total body surface area (TBSA) involvement, notably involving the hands and feet as well as the trunk and extremities.  She has failed therapy with high potency topical steroids as well as Dovonex.  The patient has a past medical history significant for hypertension and hypercholesterolemia and is being actively treated. The request is for Stelara.  

The patient has biopsy proven moderate psoriasis affecting 10% total body surface area (TBSA) with associated arthritis.  The patient has failed topical therapy and requires systemic therapy to treat her disease condition.  Based on the standard of care, the use of Stelara is medically necessary.  Stelara is likely to be more effective and with fewer potential complications than formulary oral alternatives.  Stelara is Food and drug Administration (FDA) approved for psoriasis and psoriatic arthritis and is considered as a first line agent according to the American Academy of Dermatology/National Psoriasis Foundation (AAD/NPF) psoriasis treatment guidelines. The use of Stelara is approved based on the standard of care guidelines.   

Based on the above, the insurer's denial must be overturned. 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 Stelara 90 milligrams (mg) / milliliter (ml) services is substantiated.
Appeal type: Formulary Exception
Decision: Upheld

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

The patient is a female with postmenopausal symptoms. The patient would like to use Duavee hormone replacement. Her plan requires formulary alternatives like Estradiol/Norethidrone or Bijuva prior to a non-formulary medication. 

The formulary drug would be as effective as the non-formulary drug. The use of oral or percutaneous estrogen therapy together with progesterone is not only effective for alleviating the symptoms of menopause but also for preventing endometrial hyperplasia. In the case of a normal menstrual cycle, if the symptoms of menopause are severe, the use of a combination therapy of low-dose estrogen and progesterone could effectively control a hot flash.
There are no current guidelines that support the use of one method over another and therefore, the formulary medications would be as effective as Duavee and would have the same side effect profile. There are no studies that indicate that Duavee has a lower risk profile than other combination therapies. The patient has not tried the formulary alternatives.
  
The health plan's determination is upheld in whole.