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

Diagnosis: hypertension, heart disease and diabetes.

Treatment: personal care aide (PCA) services 7 days per week, 12 hours per day (84 hours per week).

The insurer denied coverage for personal care aide (PCA) services 7 days per week, 12 hours per day (84 hours per week).

The denial is modified.

 
This is an elderly patient with hypertension, heart disease and diabetes.  She lives with her spouse in a private residence.  The insurer approved personal care aide (PCA) 5 hours/day, 7 days/week, total 35 hours/week and the request is for 12 hours/day, 7 days/week, total 84 hours/week.   

According to the Uniform Assessment System (UAS) report the patient's cognition is minimally impaired.  She has the capacity to properly activate a Personal Emergency Response System (PERS) unit and can call Emergency Medical Services (EMS) if necessary.  She is reportedly totally dependent for much of her Instrumental Activities of Daily Living (IADL) tasks including meal preparation, ordinary housework and shopping.  

The patient reportedly requires extensive assistance for bathing, lower body dressing, locomotion, ambulation, and toilet transfer/use.  Limited assistance is reportedly needed for personal hygiene and upper body dressing.  She is reportedly independent with eating and bed mobility.  The patient is frequently incontinent of bladder and continent of bowel.  There has been no reported decline in her ability to perform activities of daily living (ADL) tasks over the past 90 days.  However, she has fallen on 1 occasion over the past 90 days and evaluated in the hospital emergency department.  

The patient's clinical and functional deficits are not at a level and unpredictable as to require the requested PCA 84 hours/week.  However, her clinical condition and limited functional ability supports PCA 70 hours/week.  This physician is persuaded by the letters from the patient's treating physician describing her upper extremity impairments including the tremors and lymphedema.   This physician would also agree that given the patient's reported general weakness and debility, she may benefit from additional safety monitoring.  However, safety monitoring under personal care services does not include monitoring an individual when no other Level I or Level II personal care services task is being provided.   Based on the records reviewed, the patient's health and safety can be appropriately provided and maintained by increasing PCA to 10 hours/day, 7 days/week, total 70 hours/week.  

Based on the above, the insurer's denial must be modified. 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 personal care aide (PCA) services 7 days per week, 12 hours per day (84 hours per week) services is not substantiated. However, PCA services 10 hours/day, 7 days/week, total 70 hours/week are medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gastroesophageal Reflux Disease (GERD).
Treatment: Laparoscopic Esophageal Sphincter Augmentation. 

The insurer denied laparoscopic esophageal sphincter augmentation. 
The determination is overturned. 

This is a male patient who is being evaluated for a LINX device. He has medically refractory gastroesophageal reflux disease (GERD). He has a Demeester score of 15. There was a small hiatal hernia on an upper gastrointestinal (UGI) study. An esophagogastroduodenoscopy (EGD) was normal. There was no evidence of Barrett's esophagus. At issue is whether laparoscopic esophageal sphincter augmentation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 

Laparoscopic esophageal sphincter augmentation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 

This patient has medically refractory GERD. He has a high Demeester score and is a good candidate for the LINX device. 

As per the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES):
Conclusions: Longer-term (3-5 years) experience with the LINX Reflux Management System confirms the initial safety profile that led to Food and Drug Administration (FDA) approval of the device. The LINX device has been demonstrated to result in long-term GERD control based on symptomatic outcomes, proton pump inhibitor (PPI) utilization, and potential hydrogen (pH) studies. 
LINX is a reasonable treatment option for appropriately selected patients with GERD who meet indications for antireflux surgery. The LINX procedure is part of the armamentarium in the treatment of GERD. As such, it should be performed by surgeons familiar with the workup and different management alternatives of GERD and not offered in isolation. 
Implantation of the LINX device is indicated for appropriate patients who meet the selection criteria as described above.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gastroesophageal Reflux Disease (GERD).
Treatment: Laparoscopic Esophageal Sphincter Augmentation. 

The insurer denied laparoscopic esophageal sphincter augmentation. 
The determination is upheld. 

This is a male patient (body mass index (BMI) 24 kilograms per square meter (kg/m2)) who sought surgical evaluation. A progress note does not detail the patient's specific symptoms that have yielded the diagnosis of gastroesophageal reflux disease (GERD). He is prescribed Omeprazole and Famotidine for symptom control, but is reported to have refractory symptoms. The records do not indicate if the patient has dysphagia. 
The treating surgeon has proposed the LINX procedure as treatment of GERD. At issue is whether laparoscopic esophageal sphincter augmentation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 

Based on the submitted clinical documentation it cannot be said that the proposed LINX will be more beneficial than any standard treatment for the insured's life condition or disease. 

This patient is reported to have GERD, but the submitted clinical material does not provide detail as to what his symptoms consist of or if he has dysphagia symptomatology. His diagnostic work up is from two years ago and includes an essentially normal esophagram, an upper endoscopy that provides no description of endoscopic findings, a potential hydrogen (pH) study that shows a very minimally elevated DeMeester score over 24-hours, and an esophageal motility study that showed 33 percent (%) of swallows were failed, 80% were weak and 93% were ineffective. The Chicago classification was that of ineffective esophageal motility. The motility report does not include the distal contractile integral which is a measure of contractile vigor along time and the distance spanning the transition zone and proximal border of the lower esophageal sphincter (LES). 

While LINX is a proven therapy for the specific group of patients with proven pathologic esophageal acid exposure, preserved esophageal motility, and no contraindication to application of the LINX device, in this case the limited diagnostic work up does not establish that the patient meets these criteria. In this case, the patient does have a specific contraindication to implantation of the LINX device (ineffective esophageal motility). 

The manufacturer listed precautions/contraindications to LINX include conditions such as Scleroderma, suspected or confirmed esophagogastric cancer, prior esophageal or gastric surgery or endoscopic intervention, esophageal motor pathology, symptoms of dysphagia more than once per week, esophageal stricture or other gross anatomic abnormalities, esophageal or gastric varices, lactating, pregnant or plan to become pregnant, morbid obesity, or age less than 21.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gastroesophageal Reflux Disease (GERD). 
Treatment: Laparoscopic Esophageal Sphincter Augmentation. 

The insurer denied laparoscopic esophageal sphincter augmentation. 
The determination is upheld. 

This a male patient with a body mass index (BMI) of 24 and a history of gastroesophageal reflux disease (GERD) not controlled despite maximal medical management with a proton pump inhibitor (PPI) and histamine (H2) blocker. An upper gastrointestinal (UGI) study revealed a tiny hiatal hernia and no reflux. Esophageal manometry was not documented to be normal with a high percentage of ineffective contractions. An esophagogastroduodenoscopy (EGD) did not identify Barrett's esophagus. 24-hour potential hydrogen (pH) monitoring revealed a mildly elevated DeMeester score consistent with GERD. At issue is whether the proposed health service or treatment laparoscopic esophageal sphincter augmentation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 

The requested treatment can result in new or worsening dysphagia when poor esophageal motility is determined. It therefore cannot be determined to be more beneficial than standard treatment for this patient who documented poor esophageal motility on an esophageal manometry study. 

LINX is a standard published surgical treatment for GERD for patients that are refractory to medication or prefer not to continue medical management, in patients without a relative or absolute contraindication to the procedure. The procedure is excluded in individuals with a BMI of greater than 35 kilograms per square meter (kg/m2), prior gastric surgery, hiatal hernia greater than; 3 centimeters (cm), Barrett's esophagus with dysphagia and insufficient esophageal motility. This patient was documented to have poor esophageal motility. The LINX procedure can result in dysphagia and is generally excluded in patients with poor esophageal motility. The LINX procedure, therefore, is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hypertension

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission

The denial is upheld

 
This is an adult patient that was referred to the hospital after presenting with poorly 
controlled hypertension and near syncope.  She noted that she had run out of anti-
hypertensive medication for two weeks. She developed lightheadedness at the urgent care center after getting out of a chair without loss of consciousness.  Vital signs on arrival to the hospital were: Blood Pressure 154/95, pulse 121. Physical examination demonstrated pedal edema and an increase in pulse by 20 beats par minute when standing for three minutes. 12 lead electrocardiogram demonstrated sinus tachycardia with normal axis and no ST or T wave abnormalities.  Serum blood testing was significant for a glucose of 149.  The patient was treated with intravenous fluids (IV) and admitted to the hospital.  Computed tomography (CT) head revealed no abnormality.  Echocardiogram revealed a structurally normal heart with a preserved left ventricular ejection fraction. The patient was ultimately discharged on antihypertensive medications.  

This patient presented with hypertension and lightheadedness that occurred after running out of antihypertensive medication.  The episode was clearly triggered when arising from a seated position, consistent with an etiology of orthostasis. Physical examination and serum blood testing revealed no major abnormalities.  12 lead electrocardiogram (ECG) demonstrated sinus rhythm without abnormalities.  Echocardiography revealed a structurally normal heart with a normal left ventricular ejection fraction.   This patient falls into a low risk group for syncope. According to guidelines such patients should be managed utilizing a structured emergency department (ED) observational protocol (Reference 1) In a study of individuals presenting to the emergency room, patients that were low risk for cardiac events had an excellent prognosis and did not require admission to the hospital for further testing. (Reference 2).  In this case, the patient had a normal echocardiogram and a normal 12 lead ECG. The clinical presentation was consistent with an etiology of volume depletion.

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: Cholelithiasis

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission

The denial is upheld.

 
Acute cholecystitis and biliary complaints are common inpatient diagnoses. Acute cholecystitis is also estimated to attribute to millions of ambulatory visits each year and is a leading cause of hospital admissions. [1] Studies have shown that ambulatory laparoscopic cholecystectomy is safe and avoids an overnight hospital stay. [2, 4, 5] Factors that contribute to admission after laparoscopic cholecystectomy include drain placement, conversion to open surgery, persistent abdominal pain, nausea, and vomiting. [3] In patients without abnormalities of the bile duct or abnormal liver function tests (elevated alkaline phosphatase (ALP) and total bilirubin), ambulatory laparoscopic cholecystectomy is safe and feasible. [5, 8] A 50% (percent) increase in the liver function tests can be labelled as mild elevation and is considered negligible by many. [9] Ambulatory and/or outpatient laparoscopic cholecystectomies reduce hospital costs without compromising patient outcomes. [6]

Per clinical documentation, this patient presented to the emergency department with right upper quadrant and epigastric abdominal pain. There was associated nausea and vomiting. Vital signs in the emergency department (ED) were within normal limits. The patient was afebrile. Abdominal ultrasound demonstrated cholelithiasis without sonographic features of acute cholecystitis. Liver function tests were within normal limits. White blood cell count was elevated at 18.4. The patient underwent a laparoscopic cholecystectomy. There were no reported complications. Nursing notes indicate that surgery was canceled when first scheduled but there is no reason indicated. There is no further clinical documentation of a need for inpatient admission. Per Milliman Care Guidelines (MCG) criteria, admission is indicated when common bile duct obstruction is indicated via imaging and there are signs of systemic inflammation. [7] Peer-reviewed literature and MCG criteria indicate that inpatient admission is not necessary for this patient. 

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 is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Eosinophilic esophagitis.
Treatment: Dupixent 300 Milligram Pen Injector.
The insurer denied: Dupixent 300 Milligram Pen Injector.
The denial is upheld.

The patient is an adult female with eosinophilic esophagitis (EoE). She has ongoing dysphagia despite treatment with proton pump inhibitors and esophageal dilation. She has not failed topical steroid therapy. The physician (MD) is requesting treatment with Dupixent. Dupixent was denied, as the patient has not failed treatment with topical steroid therapy.

The proposed Dupixent is not medically necessary.

Dupixent is not clinically appropriate, accepted standard of care, or medically necessary. Dupixent was denied, as the patient has not failed a topical steroids treatment for at least eight weeks. 
"Dupilumab, a precision therapeutic mAb that blocks the shared IL-13 (Interleukin-13) and IL-4 receptor, is the first drug to advance through clinical trials and receive US Food and Drug Administration approval for EoE." (4)
"Therapies include proton pump inhibitors, elimination diets, and topical corticosteroids. Effective treatment can reverse tissue fibrosis in some patients, as well as decrease the rate of food impactions." (6)
This patient has eosinophilic esophagitis and has failed proton pump inhibitors. Dupixent is the only drug that is Food and Drug Administration (FDA) approved for use in eosinophilic esophagitis. While the patient has not failed systemic steroids, the long-term use of systemic steroids is not safe. After proton pump inhibitors, it is standard of care to use topical therapy such as fluticasone. As this patient has not failed topical steroids therapy, it would not be standard to use Dupixent. Therefore, the requested Dupixent is not clinically appropriate, accepted standard of care, or medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intracept Procedure
The insurer denied the Intracept Procedure.
The determination is upheld.

This is a male patient with a history of low back pain. He has had physical therapy, injections and medications without relief. The neurologic exam shows no motor, sensory or reflex abnormalities. The lumbar magnetic resonance imaging (MRI) shows degenerative changes at lumbar (L)5- sacral (S) 1. The provider has recommended an Intracept procedure.

At issue is whether the proposed health service or treatment Intracept procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. No. While this is a promising technology, the literature describes further research needing to be performed, particularly from non-industry sources. Urits et al cite "Chronic low back pain (CLBP) is a difficult yet common diagnosis that affects a significant portion of patients worldwide. In efforts to combat this debilitating disease, researchers have made great progress in understanding the pathophysiology of lower back pain (LBP) in addition to unveiling the anatomy of the vertebrae in search of appropriate treatment options. As a result, with the growing evidence supporting the vertebrogenic model that involves the BVN (basivertebral nerve), radiofrequency (RF) ablation of the BVN has emerged as a possible minimally invasive procedure to treat LBP. Several studies have supported the safety, durability, and efficacy of RF ablation of the BVN. There is also convincing evidence that BVN ablation is more beneficial than the current standard of care for the treatment of CLBP. However, 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 CLBP and improve the quality of life of CLBP patients in the near future". The introduction of new devices and a larger number of independent studies would greatly enhance the confidence in the outcomes reported with this treatment modality in order to ultimately benefit patients, clinicians, and society".
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intracept Procedure
The insurer denied the Intracept Procedure.
The determination is upheld.

This is a male patient with mechanical lancinating discogenic pain. The pain occurs when he transitions from a seated position to a standing position. His pain is sharp and intermittent. His last injection helped for approximately 7 weeks. He now has severe lancinating pain across his low back in the lumbosacral region. Jogging does not cause his pain. He denies numbness tingling or weakness into his legs. He has done well with his low back pain until his last interlaminar epidural steroid injection, however, his pain has returned. Physical examination demonstrates full range of motion of his lumbar spine with bilateral negative straight leg raises. Lumbar (L) 4 patellar reflexes are equal and symmetric bilaterally. Heel-to-toe gait is intact. Magnetic resonance imaging (MRI) of the lumbar spine demonstrates at lumbar (L) 5-sacral (S) 1 severe disc degeneration with Modic type I endplate changes which have progressed. There is mild right neural foraminal stenosis. Based on the imaging studies and his pain for multiple years, the plan is for an L5-S1 Intracept procedure. At issue is whether the proposed health service or treatment Intracept procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service or treatment, Intracept procedure, is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

There are no high-quality non-industry sponsored studies that establish that treatment with the Intercept procedure results in improved/better health outcomes when compared to the existing treatments. There is insufficient evidence in the medical literature to obtain definitive conclusions about the clinical safety and efficacy of the intercept procedure. Multiple studies have been performed but have not compared the Intracept procedure to existing conservative treatments. The authors of these studies have also been shown to be industry related to the manufactures of the device being studied. Therefore, based on the current literature, the Intracept procedure is not likely to be more beneficial than standard treatment in this clinical scenario.

Current evidence on the use of intraosseous radiofrequency ablation of the basivertebral nerve (Intracept) as a treatment of low back pain is limited to a single small observational study in 1 randomized control trial. The studies have not demonstrated long-term improvements in patient health outcomes, including pain and disability measures. In addition, no United States (US) guidelines based on research recommend this treatment.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intracept Procedure
The insurer denied the Intracept Procedure.
The determination is upheld.

This is a male patient with low back pain with magnetic resonance imaging (MRI) of the lumbar (L) spine showing multiple levels of degeneration who is under review for basivertebral ablation treatment. Magnetic resonance imaging (MRI) of the L spine shows listhesis at L5-sacral (S)1, cyst at L3-4 with joint arthropathy at multiple levels. At issue is whether the proposed health service or treatment, Intracept procedure, is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service or treatment Intracept procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The sacroiliac (SI) joints are degenerated on MRI and the lumbar spine has multiple levels of degeneration. Therefore, multiple other sources of pain are noted and must be ruled out and treated prior to this ablation treatment. Han et al noted "in the previous review, magnetic resonance imaging (MRI) evidence of a high intensity zone and disc degeneration, and centralization phenomenon were found to be informative to identify the disc as the source of low back pain and a combination of sacroiliac joint provocation tests were found to be informative to identify the sacroiliac joint (SIJ) as the source of low back pain. The results of our review reinforced the results of the previous review as a larger number of studies were able to be pooled. The previous review found there was no informative index tests to identify the facet joint as the source of low back pain, however, the results of our review found that facet joint uptake on single-photon emission computed tomography (SPECT) was informative." (4) Therefore, ruling out alternative etiologies is critical.