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

Diagnosis: GERD-gastroesophageal reflux disease.
Treatment: LINX Procedure
The insurer denied the LINX Procedure.
The determination is overturned.

This is a patient with gastroesophageal reflux disease (GERD). An upper gastrointestinal (UGI) study showed a small hiatal hernia with severe GERD. The Demeester score is 27.2. An esophagogastroduodenoscopy (EGD) showed reflux esophagitis. Manometry was normal.
The patient has been on Protonix and Pepcid. The LINX procedure is under review as to whether it is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Yes. It 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 severe GERD. GERD is not controlled with medications. The patient does not have Barrett's esophagus.
LINX has been the standard of care as per Society of American Gastrointestinal and Endoscopic Surgeons (SAGES):
The Food and Drug Administration (FDA) Instructions for Use (2012) are:
Indications
The LINX system is labeled for use in GERD patients with abnormal potential hydrogen (pH) testing who continue to have chronic symptoms despite anti-reflux therapy.
Precautions (summary)
The LINX device has not been evaluated in patients with a hiatal hernia larger than 3-cm. Use of LINX device in patients with a hiatal hernia larger than 3-centimeters (cm) should be considered on the basis of each patient's medical history and severity of symptoms.
The safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's esophagus or Grade C or D (Los Angeles [LA] classification) esophagitis.
The safety and effectiveness of the LINX device has not been evaluated in patients with major motility disorders.
The safety and effectiveness of the LINX Reflux Management System has not been established for the following conditions:
1) Scleroderma
2) Suspected or confirmed esophageal or gastric cancer
3) Prior esophageal or gastric surgery or endoscopic intervention
4) Distal esophageal motility less than 35- millimeters of mercury (mmHg) peristaltic amplitude on wet swallows or less than (<) 70 percent (%) (propulsive) peristaltic sequences or a known motility disorder (such as Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive lower esophageal sphincter (LES)).
5) Symptoms of dysphagia more than once per week within the last 3 months.
6) Esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.).
7) Esophageal or gastric varices.
8) Morbid obesity (body mass index (BMI) greater than (>) 35).
9) Age less than (<) 21
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD-gastroesophageal reflux disease.
Treatment: LINX Procedure
The insurer denied the LINX Procedure.
The determination is overturned.

This patient has a (body mass index (BMI) of 24 kilograms per square meter (kg/m2)) and sought surgical evaluation for the condition of gastroesophageal reflux disease (GERD). His symptoms include heartburn. He is treated with Pantoprazole and famotidine for reflux symptoms, but has breakthrough symptoms. The patient was evaluated with the following diagnostics.
An esophagram showed normal esophageal motility. There was severe reflux and no hiatal hernia. An esophagogastroduodenoscopy (EGD)  identified Grade A esophagitis at the gastroesophageal junction. Potential hydrogen (pH) testing was performed while off acid suppressing medication and showed a DeMeester score of 27.2 (normal less than [<] 14.7). Esophageal manometry testing showed normal peristaltic pressures. All swallows were peristaltic.
The treating surgeon has proposed the LINX procedure as treatment of GERD. At issue is whether the LINX procedure 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 records and the body of published peer reviewed literature, the LINX procedure 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 with GERD who has successfully completed a comprehensive evaluation that establishes the diagnosis of pathologic esophageal acid exposure, preserved esophageal motility and no alternative diagnosis.

LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the United States Food and Drug Administration (FDA) to be lawfully marketed for the proposed use since 2012. LINX is not subject to review and approval by any institutional review board for the proposed use. LINX is not the subject of an ongoing clinical trial that meets the definition of a Phase 1, 2 or 3 clinical trial set forth in the FDA regulations. Finally, there is sufficient long-term data to support that this therapy is as efficacious as the established alternative (laparoscopic fundoplication) with less incidence of inability to belch or vomit (as can be associated with fundoplication).

The patient has symptoms of chronic GERD. He has been appropriately evaluated with a potential hydrogen (pH) study, motility testing, esophagram, and upper endoscopy. There is confirmed pathologic esophageal acid exposure based on objective pH testing. There is no contraindicating esophageal motor condition based on the motility testing or esophagram. Esophagogastroduodenoscopy (EGD) identifies no contraindicating anatomic abnormality of the esophagus or stomach. 
This treatment (LINX) is consistent with the diagnosis and treatment of this patient's condition. It is appropriate according to generally accepted standards of good medical practice. It is not for the convenience of anyone. LINX is the most appropriate service required to provide safe and adequate care.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD-gastroesophageal reflux disease.
Treatment: LINX Procedure.
The insurer denied the LINX Procedure.
The determination is overturned.


This is a patient with a body mass index (BMI) of 24 kilograms per square meter (kg/m2) with a history of long-standing gastroesophageal reflux disease (GERD) refractory to medication-a proton pump inhibitor (PPI) and histamine (H2) blocker. The patient underwent a 24-hour potential hydrogen (pH) study that revealed an elevated DeMeester score consistent with GERD. An esophagogastroduodenoscopy (EGD) revealed esophagitis without a significant hiatal hernia or evidence of Barrett's esophagus. Manometry revealed normal esophageal motility. At issue is whether the LINX procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Yes. The LINX procedure 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 GERD refractory to medical management. Surgical treatment options that are considered standard today include laparoscopic Nissen fundoplication and the LINX procedure. Both of these treatments have been shown in published studies to be more effective than medical management. LINX is comparable for mid-long-term studies to be as effective and durable as laparoscopic Nissen fundoplication with less risk of mortality and major morbidity. It has been recommended based on the available published literature to be a standard surgical treatment for GERD in newly updated nationally published guidelines from the Society for Gastrointestinal and Endoscopic Surgeons. The exclusions to LINX and Nissen fundoplication include a BMI greater than (>) 35 kg/m2 in which case treatment of obesity is thought to be important for treatment of GERD. Other exclusions for LINX include Barrett's esophagus with dysplasia, age less than (<) 18 and prior gastric or bariatric surgery. This patient has medically refractory GERD without any documented exclusion to treatment. The requested LINX procedure is therefore considered standard treatment for GERD.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cellulitis of the right lower extremity. 
Treatment: Inpatient Admission. 

The insurer denied coverage for inpatient admission. 

The denial is upheld. 

The patient has a past medical history significant for cellulitis who presented to the emergency room with complaints of pain and erythema of the right lower extremity. Vitals on presentation included: Temperature. 98.5 degrees Fahrenheit, Blood Pressure-122/77, Pulse-87, Respiratory Rate-20, oxygen saturation 96% (percent) on room air. Laboratory values were notable for the following: White Blood Cells (WBC)-20.6, Hemoglobin-14.1, Hematocrit-43.2, creatinine-1.3, glucose-68. The patient was admitted for cellulitis of the right lower extremity and was started empirically on antibiotics (cefazolin and vancomycin). Cultures remained negative. The patient remained afebrile, hemodynamically stable, and clinically improved. He was discharged to continue oral antibiotics as an outpatient. 

According to documentation, the patient was admitted with right lower extremity cellulitis. Otherwise, the patient was afebrile, hemodynamically stable; laboratory results were unremarkable except for an elevated WBC count. Moreover, the patient had no evidence of a disseminated infection, and no surgical intervention was required. Based on above findings, patient met criteria for observation level of care. 

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

The insurer's denial of coverage for the inpatient admission is upheld. Medical Necessity is not substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Neck and Back Pain. 
Treatment: Pain Management (Intracept procedure - 64628 x 1). 

The insurer denied: Pain Management (Intracept procedure - 64628 x 1). 
The denial is overturned. 

The patient is an adult female with several years of 5-10/10 pain that has not improved significantly with multiple treatments, including acupuncture, chiropractic care, injections (lumbar epidural steroid injection), medication management (Ambien, Diazepam, Diclofenac, Flexeril, ibuprofen, Methylprednisolone, and Percocet), and physical therapy. 

The patient's pain has had a significant impact upon ADLs (activities of daily living), such as sitting. Nothing has provided significant sustainable relief. 

The patient had an MRI (magnetic resonance imaging). The MRI (magnetic resonance imaging) demonstrated Modic type I changes at disc space L3-L4. Confirming vertebrogenic changes at L3 and L4. 

The health plan should cover the requested Intracept procedure. 

The Intracept procedure is FDA (United States Food and Drug Administration)-approved, and there is enough data in the medical literature to show it is safe and effective in the treatment of vertebrogenic low back pain. A prospective, randomized, multi-center study by Khalil et al in 2019 and another prospective, randomized, multi-center study done by Fischgrund also in 2019 both presented high quality evidence of efficacy and safety of the procedure. 

The patient in this case has vertebrogenic pain confirmed by MRI (magnetic resonance imaging) and she has not responded to multiple treatments, including acupuncture, chiropractic care, injections (lumbar epidural steroid injection), medication management (Ambien, Diazepam, Diclofenac, Flexeril, ibuprofen, Methylprednisolone, and Percocet), and physical therapy. She is an ideal candidate for the procedure based on the current medical literature. 

The requested Intracept procedure is more beneficial. 

To this reviewer's knowledge, there are no other treatments specifically for vertebrogenic low back pain; however, there are other treatments for other causes of chronic low back pain. Since the patient in this case has low back pain secondary to vertebrogenic source, then the Intracept procedure is the only beneficial procedure available.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Neck and Back Pain. 
Treatment: Pain Management (Intracept procedure - 64628 x 1). 

The insurer denied: Pain Management (Intracept procedure - 64628 x 1). 
The denial is upheld. 

The patient is an adult female with low back pain in whom an Intracept procedure has been requested. The procedure was denied coverage by the as experimental/investigational. The denial is being appealed. 

The patient has failed conservative treatment in the form of PT (physical therapy), epidural steroid injections, and chiropractic care. The patient has failed multiple medications including steroids and NSAIDs (non-steroidal anti-inflammatory drugs). MRI (magnetic resonance imaging) shows Modic changes. Physical exam shows a positive SLR (straight leg raise), and some weakness on hip flexion. 

The health plan should not cover the requested Intracept procedure. 

The patient is an adult female with low back pain in whom an Intracept procedure has been requested. The procedure was denied coverage by the health plan as experimental/investigational. The patient has failed conservative treatment in the form of PT (physical therapy), epidural steroid injections, and chiropractic care. The patient has failed multiple medications including steroids and NSAIDs (nonsteroidal anti-inflammatory drugs). MRI (magnetic resonance imaging) shows Modic changes.  Physical exam shows a positive SLR (straight leg raise), and some weakness on hip flexion. 

The Intracept procedure (interosseous basivertebral nerve ablation) is not an intradiscal procedure. The procedure is an FDA (United States Food and Drug Administration)-approved procedure for axial low back pain. It has been shown effective in RCT (randomized controlled trials) with 5-year results. It is a new Food and Drug Administration (FDA) approved intraosseous nerve ablation for the treatment of chronic low back pain in the treatment of vertebrogenic related chronic low back pain. It is typically used in patients with significant Modic type 1 or type 2 vertebral endplate changes, typically in situations where conventional and typical options have been exhausted.

However, the patient in this case is not documented to have failed or attempted sacroiliac joint injections, which are common causes of axial low back pain. The Intracept procedure should be employed after all conventional and evidence-proven alternatives have failed. The literature has not shown superiority over conventional, less invasive treatments, which is the basis to the denial. Given that the alternatives such as sacroiliac interventions do show favorable outcomes in the literature, have lower risk, and morbidity, the requested Intracept procedure is not medically appropriate.
The requested Intracept procedure is not more beneficial than any standard treatment for the insured's condition or disease.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Neck and Back Pain. 
Treatment: Pain Management (Intracept procedure - 64628 x 1). 

The insurer denied: Pain Management (Intracept procedure - 64628 x 1). 
The denial is upheld. 

The patient is an adult female with low back and left lower extremity pain. She has tried chiropractor care, physical therapy, and acupuncture in the past as well as medications of Percocet, oral steroids, and Flexeril. MRI (magnetic resonance imaging) of the lumbar spine shows dextroscoliosis, slight retrolisthesis of L4 on L4, mild disc bulging, and degenerative changes. A few years ago she responded well to epidural steroid injections, and as such a repeat injection of left L3-4, L4-5 transforaminal epidural steroid injection was recommended. Further considerations were L3-5 medial branch blocks and Intracept procedure at L3-4. The request for Intracept was denied coverage by the health plan as experimental/investigational. The denial is being appealed. 

The health plan should not cover the requested Intracept procedure. 

The requested Intracept procedure is not known to be more beneficial. 
Review of literature shows moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic back pain who are selected based on Type I or Type II Modic changes as well as other inclusion and exclusion criteria used in published literature to date. However, non-industry funded high-quality, large prospective studies are needed to confirm these findings. 

At this time, there is not enough valid scientific evidence to show that the expected health benefits from the procedure, supply, equipment, or service are clinically significant and will have a greater chance of benefit, without a disproportionately greater risk of harm or complications, than other possible treatments; and that generally approved forms of treatment that are less invasive have been tried and did not work or are otherwise unsuitable. There is a lack of sufficient (enough) peer-reviewed literature and data regarding the long-term outcomes of the procedure. As such the requested Intracept procedure is not medically appropriate and should not be covered by the health plan.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Neurological abnormalities.

Treatment: Inpatient admission.

The insurer denied coverage for inpatient admission.

The denial is overturned.

This case involves an adult with a history of hypertension, heart failure, diabetes, asthma, marijuana use, and alcohol use who presented to the emergency room (ER) with complaints of dizziness and loss of consciousness. On assessment, imaging of the head revealed no acute infarct while laboratory values showed low potassium and sodium levels. The patient was subsequently admitted for further work-up to manage his symptoms of syncope, hypotension, hyponatremia, hyperkalemia, acute renal failure, and a new neurological issue. Prior to the patient leaving, it was determined that that he had arrived at the ER for evaluation when he had reports of a sudden onset of dizziness causing him to fall onto his stove at home. He tried to ambulate and fell again. He checked his blood pressure at home, which was low at 74/50. He complained of headache, chest pain, nausea, 3 episodes of vomiting, weakness in the hands and feet, blurry vision prior to his fall, with his initial vital signs showing temperature of 97.4 degrees Fahrenheit, heart rate at 60, respiration rate 18, and blood pressure at 100/60. On further examination, the patient appeared to have dry mucous membranes, lower abdominal tenderness, weakness in the right arm and right leg, and an abnormal gait. Initial laboratory studies were remarkable for low albumin of 3.2, elevated blood urea nitrogen of 54, elevated creatinine of 2.77, low potassium of 3.2, low sodium at 126, low chloride of 88, elevated bicarbonate of 31, low calcium of 8.2, elevated white blood cell count at 12.4, low hemoglobin at 11.6, low hematocrit of 32.5%, and elevated neutrophil percentage of 80.35. The patient also had elevated N-terminal pro-brain natriuretic peptide (proBNP) at 212 picograms per milliliter (pg/mL). Chest radiograph demonstrated 23 millimeter (mm) right apical pulmonary nodule with some calcification, likely representing granuloma and emphysematous change. The patient remained inpatient until he left against medical advice (AMA).  

According to the Milliman Care Guidelines, criteria for admission to inpatient care for those individuals presenting with neurological abnormalities were met. There were concerns that the patient has suffered from an acute cerebrovascular accident given his right-sided weakness. Inpatient mission is indicated when there is a new onset of severe neurologic symptoms. It was therefore determined that the patient required additional work-up, and while the patient left AMA before he could have a magnetic resonance imaging study (MRI) and complete stroke work-up, the time spent in the acute care setting was appropriate and within standard of care. Therefore, the inpatient admission was medically necessary for this patient.

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 the inpatient admission is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dementia, lumbar stenosis, osteoarthritis, diabetes
Treatment: Increase Personal Care Aide (PCA) Services Level II: 12 Hours/Day, 7 Days/Week; 12 Hours/Day, 7 Days/Week (Split Shift) for a Total of 168 Hours/Week
The insurer denied an increase in PCA services level II: 12 hours/day, 7 days/week; 12 hours/day, 7 days/week (split shift) for a total of 168 hours/week.
The denial is upheld.

This elderly female patient has conditions including dementia, lumbar stenosis, osteoarthritis, hypertension, and diabetes. She is appealing denial of an increase in personal care aide (PCA) services for a total of 168 hours/week. The health plan approved PCA 8 hours/day, 7 days/week, 56 hours/week. 

The patient's Uniform Assessment System (UAS) evaluation performed recently showed moderately impaired cognition and functional status: total dependence with housework and managing finances; maximal assistance with meal preparation, managing medications, shopping, bathing, personal hygiene, dressing, walking, locomotion, and toileting; extensive assistance with phone use and bed mobility; and supervision with eating. The patient has urinary incontinence. Compared to UAS evaluation completed earlier this year, there has been a decline with toilet use.

A letter from the patient's physician notes the patient's medical conditions; it notes the patient had a recent fall and requires 24-hour home aid support with 12-hour shifts.

The proposed treatment is not medically necessary.

Personal care services (PCS) is necessary when assistance cannot be met from use of informal caregivers, by formal services, or by adaptive or specialized equipment or supplies. Continuous or split shift PCS is uninterrupted care, by more than one PCA, for more than 16 hours in a calendar day for an individual that needs assistance with toileting, walking, transferring, turning, or positioning; the frequency of care would be unlikely to give the aide five hours daily of uninterrupted sleep during the aide's shift.

This patient has multiple chronic conditions. She is appealing denial of increase in PCA services for a total of 168 hours/week. The health plan approved PCA 8 hours/day, 7 days/week, 56 hours/week. UAS evaluation performed recently showed the patient requires assistance with all activities of daily living (ADLs), except eating. There is no significant decline compared to the UAS evaluation completed earlier this year. An appeal statement notes the patient had a recent fall. The information provided does not support that the patient has continuous needs that require PCA services for a total of 168 hours/week. Nor does the information provided show a decline in the patient's functioning to support an increase in PCA hours from the current 56 hours/week. The proposed PCA 168 hours/week is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Supracondylar fracture
Treatment: Inpatient hospital admission
The insurer denied coverage for the inpatient hospital admission. 
The denial is upheld.

According to the documentation submitted, this is a child with no significant past medical history. The patient presented to the emergency room (ER) with complaints of left arm pain after falling. Imaging revealed a left type 3 supracondylar fracture. The patient underwent a closed reduction and percutaneous pinning of the left elbow. The patient was monitored after surgery and was discharged. 

There were no concerns or complications requiring inpatient level of care. 

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