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

Diagnosis:  Low back pain.
Treatment:  Thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (Intracept procedure) (procedure codes 64628, 64629).

The insurer denied coverage for thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (Intracept procedure) (procedure codes 64628, 64629).  
The denial is overturned.

This case involves a patient diagnosed with discogenic low back pain, vertebral genic low back pain, spondylosis of the lumbosacral joint without myelopathy, and degenerative disc disease of the lumbar spine.  She failed to respond to physical therapy, chiropractic care, a home exercise program, activity modification, and medication management along with injections for at least 6 months before she was seen for follow-up visit. The document noted that the patient had no radicular symptoms and had axial low back pain with midline tenderness and pain exacerbated with flexion and lifting. Her pain level was 8/10 with flareups and was limiting her sleep and activities. Magnetic resonance imaging (MRI) of the lumbar spine without contrast  showed significant vertebrogenic endplate changes with fatty bone marrow changes at lumbar (L)3, L4, L5 along with Modic type I and type II changes in multiple areas. The treating physician was recommending that the patient proceed with the Intracept procedure to address her chronic low back pain.  

Scientific evidence in peer-reviewed literature supports result of improvement in health outcome.

Thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (Intracept procedure) (procedure codes 64628, 64629) is one of the best available treatments for this patient at this time.

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

Current peer-reviewed medical literature states that low back pain is one of the most prevalent musculoskeletal ailments in the United States. Intraosseous radiofrequency ablation of the basivertebral nerve is an effective and durable therapy for low back pain and can be offered to patients who have chronic low back pain of greater than 6 months of duration, failure to respond to noninvasive therapies for 6 months, with either Modic Type I or Type II changes at L3-S (sacral) 1. The information provided for the review noted that the patient was found to have discogenic low back pain and failure of nonoperative measures for at least 6 months. The patient was symptomatic on clinical assessment and had diagnostic imaging evidence of Modic type I and II changes at multiple levels of the lower lumbar spine. Current literature has found the Intracept procedure to be safe and effective in providing sustained relief of low back pain resulting in improvement in health outcomes. 

The denial of  thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (Intracept procedure) (procedure codes 64628, 64629) . This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are not substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Low back pain.
Treatment:  Thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (Intracept procedure) (procedure codes 64628, 64629).

The insurer denied coverage for thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (Intracept procedure) (procedure codes 64628, 64629).  

The denial is upheld. 

This patient has chronic low back pain (CLBP). She has tried physical therapy, a home exercise program, massage and chiropractic therapy. Her medication trials have included: Cymbalta, Ibuprofen, Tylenol and over the counter non-steroidal anti inflammatories. She has had Epidural Steroid injections, sacroiliac (SI) joint injections, medial Branch blocks and radiofrequency (RF) ablation. Her magnetic resonance imaging (MRI) shows  Modic type I and II changes at lumbar (L)3, L4 and L5.  The request is for RF ablation of the Basivertebral nerves (BVN) at L3, L4 and L5.	

The publications to date have been company sponsored and had methodology flaws. There are 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. 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."

This patient is not a good candidate for the requested procedure. It is not the best available treatment for this patient at this time. This procedure is not likely to be more beneficial than the standard of care.

In summary, the denial of  thermal destruction of intraosseous basivertebral nerve first 2 vertebral bodies (Intracept procedure) (procedure codes 64628, 64629) should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Asthma exacerbation
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission
The denial is upheld

This patient has a history of asthma. The patient presented to the emergency department (ED) with complaints of cough, shortness of breath and fever of 3 days duration. The patient had been seen in urgent care the previous day and was discharged home on oral (PO) steroids and inhalers. She did not feel better, so she came to ED. Vital signs at presentation were: Temperature 99.7 degrees Fahrenheit (F), Respiratory rate 20, Heart Rate 106, and Blood Pressure 139/84. The patient was in no acute distress. Oxygen (O2) saturation was 94%(percent) and the lung exam revealed bilateral wheezes. Heart sounds were normal. The abdomen was soft, non-tender. The patient was alert and oriented x(times) 3 with a non-focal neuro exam.

White blood cells (WBC) were 13,800, Hemoglobin (Hgb) 12.1, Electrolytes, blood urea nitrogen (BUN) and Creatinine were within normal limits. Results of venous blood gasses (VBG) were pH 7.39, partial pressure of carbon dioxide (PCO2) 40. The chest x ray was positive for bilateral patchy lower lobes and a right suprahilar infiltrate.

The patient was admitted with a diagnosis of asthma exacerbation secondary to pneumonia, bacterial versus viral. She was treated with PO steroids, bronchodilators, intravenous (IV) Rocephin and PO azithromycin. The patient also had some pleuritic/pericardial chest pain. Electrocardiogram (EKG) revealed no acute changes. Troponin was negative. The patient was treated with pain meds.  Her peak expiratory flow (PEF) was 250 initially.

The patient was able to tolerate food and fluids and remained stable after admission. She was continued on antibiotics, steroids, and bronchodilators.  Oxygen saturation was stable and she was discharged home on PO antibiotics and other PO medications.

This patient did not need acute inpatient hospitalization. She could have been placed in observation status while diagnostic testing and treatment were initiated. Observation could be for up to 48 hours. This patient was afebrile and hemodynamically stable, was tolerating PO. She could have been discharged home on PO meds after a period under observation. The patient's pneumonia was not severe and responded to treatment.

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 admission is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Central Nervous System/Neuromuscular Disorder/Other/Duchenne Muscular Dystrophy (DMD).
Treatment:  Physical Therapy: 39 Home Health Visit(s).

The health plan denied the requested Physical Therapy: 39 Home Health Visit(s) as not medically necessary. The health plan's determination is overturned.

The patient is a male with a history of Duchenne Muscular Dystrophy and a cardiac transplant. According to the records, he is wheelchair bound with contractures in all 4 limbs. He is dependent in most activities of daily living (ADLs), however, he has use of his upper extremities to operate a wheelchair. His neurologist has requested physical therapy 3 times a week.

At issue is the medical necessity for the requested physical therapy.

The health plan's determination of medical necessity is overturned, in whole.

Yes. The requested health service/treatment of physical therapy is medically necessary for this patient.

Duchenne Muscular Dystrophy is a progressive disorder. It is one of the most common and severe forms of muscular dystrophy and usually affects boys in early childhood; people with the condition will usually only live into their 20s or 30s. Mobility assistance including exercise, physiotherapy and physical aids are crucial to maintaining quality of life.

Therapy evaluations must clearly identify patient problems and specify objective measurements of physical deficits. In this case, considering the patient's age and medical condition, this presentation would be considered atypical and continued therapy appears appropriate for 3 visits a week for 12 weeks.
Appeal type: Medical necessity
Decision: Overturned

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

The patient is a female who presented with fever, cough, and congestion. She was well until 5 days prior to presentation when she developed a fever to 101 Fahrenheit. She was given acetaminophen at that time, but the fever recurred. She then developed a cough and nasal congestion. The cough worsened over time and was associated with sputum production. On the day of presentation, she developed difficulty breathing, with fast breathing and pulling in her chest.

Inpatient Hospital Stay was medically necessary for this patient.
This is a very young girl who presented with respiratory distress from bronchiolitis. She had retractions and wheezing, and continued to have these symptoms despite appropriate and intensive treatment in the emergency department setting, including nebulized treatments and intravenous corticosteroids. She required hospital admission for ongoing treatment with frequent bronchodilators (initially every 2 hours), intravenous fluids, and parenteral steroids. In fact, during the admission she had an episode of desaturation and also required supplemental oxygen.
She required intensive treatments and monitoring that necessitated an inpatient setting, including frequent breathing treatments, intravenous corticosteroids, and intravenous fluids to maintain her hydration status. She also required supplemental oxygen for a period of time. This level of care requires an inpatient hospital admission.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's disease
Treatment: Stelara
The insurer denied Stelara.
The determination is overturned.

The patient has Crohn's disease. He was on Remicade for two years with a colonoscopy showing cecal and sigmoid colon inflammation (biopsies showed active disease); he had bleeding after the colonoscopy; the Remicade level was low and anti-drug antibody level was high. He was started on Stelara; testing on the standard dose showed a low Stelara level of 2.8 (with no anti-Stelara antibodies). At issue is the medical necessity of Stelara.

Yes, the request for Stelara is medically necessary over the use of Entyvio for the treatment of Crohn's disease in this case. Stelara and Entyvio are recommended by American College of Gastroenterology guidelines for the treatment of Crohn's disease [1]. American Gastroenterological Association (AGA) guidelines for the treatment of Crohn's disease specifically do support the use of Entyvio in patients with Crohn's disease [2]. However, the guidelines recommend Stelara over Entyvio in Crohn's disease patients who have secondary non-response to an anti-tumor necrosis factor (such as Inflectra, attempted by the patient), stating "In adult outpatients with moderate to severe Crohn's disease who previously responded to infliximab (secondary nonresponse), the AGA recommends the use of adalimumab or ustekinumab and suggests the use of vedolizumab over no treatment for the induction of remission" [2]. The formulary alternative Humira is a tumor necrosis factor (TNF) medication. The mechanism of Stelara (ustekinumab) is entirely different than that of immunosuppressants and anti-TNF medications, which the patient has failed [3]. A recent study demonstrated that a significant majority of patients who have failed an anti-TNF medication achieve and maintain response with Stelara [4]. Two studies showed that Stelara appears more effective than Entyvio in the treatment of Crohn's disease, with one finding odds ratio of remission of 2.01 and the other 2.58 [5,6]. Additionally, the patient has already initiated Stelara, with a measurable Stelara level; discontinuation and change to an alternative therapy such as Humira may be ineffective. For these reasons, the request is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Parkinson's disease, chronic obstructive pulmonary disease (COPD) and left above knee amputation.

Treatment: Personal care assistance (PCA) services 24 hours per day, 7 days per week split shift.

The insurer denied coverage for PCA services 24 hours per day, 7 days per week split shift.

The denial is overturned.

This is an elderly patient with multiple medical problems including Parkinson's disease, COPD and left above knee amputation. He lives alone, bed bound and receiving hospice care. He was recently hospitalized due to a respiratory infection. He is currently approved by the insurer for PCA 84 hours/week and requesting a change to 24 hours per day, 7 days per week, live in or split shift.  

According to the recent Uniform Assessment System (UAS) report, the patient's cognition is minimally impaired. He requires maximal assistance for bathing, lower body dressing and toilet use. He has a Foley catheter for bladder management and incontinent of bowel. Extensive assistance is needed for upper body dressing and bed mobility (described as "bed bound"). The PCA uses a Hoyer lift for transfers out of the bed and also must feed him.      

The patient is at extreme risk for falls, pressure ulcers and recurrent pulmonary as well urinary infections. His condition and functional decline are at a level and unpredictable as to require PCA services 24 hours/day, 7 days/week (split shift). Based on the records reviewed, the PCA is unlikely capable of providing for the patient's functional needs with the ability to obtain an uninterrupted 5 hours of sleep. The patient's health and safety would be more appropriately provided and maintained at home with PCA services 24 hours/day, 7 days/week split shift.

Taken into consideration were the clinical standards of the plan, information provided concerning the patient, the attending physician's recommendation and applicable generally accepted practice guidelines developed by the federal government, national or professional medical society, board and associations. All decisions are evidence-based.  

From a physical medicine and rehabilitation perspective, PCA services 24 hours/day, 7 days/week (split shift) is medically necessary.  

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 personal care assistance (PCA) services 24 hours per day, 7 days per week split shift is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: hypertension, breast cancer and Parkinson's disease

Treatment: Personal care worker services 8 hours/day, 7 days/week; 56 hours/week

The insurer denied coverage for Personal care worker services 8 hours/day, 7 days/week; 56 hours/week
The denial is overturned

This is a patient with multiple medical problems including hypertension, breast cancer and Parkinson's disease. She lives alone in a private residence. The insurer approved personal care worker (PCW) services 6 hours/day, 7 days/week; 42 hours/week and the request is for 8 hours/day, 7 days/week; 56 hours/week, which is currently under review.

The Uniform Assessment System (UAS) report was reviewed. The patient's cognition is described as modified independent. However, extensive assistance is required for bathing, dressing, eating and toilet transfer/use. She is frequently incontinent of urine and continent of bowel. Limited assistance is needed for bed mobility and ambulation. The patient's functional ability has not significantly changed compared to the prior. However, according to the patient's treating neurologist her medical condition is worsening. This physician would agree with the treating physician and in both instances the patient's medical condition and functional needs are at a level or unpredictable as to require the requested increase in PCW services to 7 days/week, 8 hours/day; 56 hours/week. The patient's health and safety is more appropriately provided and maintained by the requested increase PCW services to 7 days/week, 8 hours/day; 56 hours/week.

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 personal care worker (PCW) services 7 days per week, 8 hours per day; 56 hours per week is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Acute Coronary Syndrome; Heart Problems; s/p Cardiac Catheterization. 
Treatment: Inpatient Hospital Stay. 

The insurer denied the inpatient hospital stay. 
The health plan's determination is upheld. 

The patient is a male who had an inpatient hospitalization. The patient has a history of hypertension and hyperlipidemia. He presented with dull left-sided chest pain, palpitations, shortness of breath. The pain would increase while he was laying down or with exertion. There was no relief with a Nitrate. His vital signs and oxygen saturation were essentially normal. The troponin was negative. His chest x-ray was non-acute. It is also reported the shortness of breath was better when he was on his left side and on his back and worse when on his right side. 

The patient also had pain in his left shoulder and back due to previous back surgery and a compression fracture of his vertebrae. The electrocardiogram (ECG) was reported to demonstrate some interference of the atrial conduction of Bachmann's bundle (biphasic P waves). He remained stable. An uncomplicated catheterization was negative for severe coronary artery disease (CAD). The patient was discharged. 

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

The requested health service and treatment of an inpatient hospital stay was not medically necessary for the patient. The patient presented with chest pain and remained stable. There was no congestive heart failure (CHF), respiratory distress, ongoing symptoms suggestive of treatment refractory angina or angina equivalent, severe arrhythmia or hemodynamic instability. The patient did not have a serious cause for chest pain, such as a pulmonary embolism (PE) or aortic dissection. He did not need prolonged intravenous (IV) medications or oxygen support, introduction of high risk medications requiring ongoing in-hospital monitoring and he did not have severe catheterization related complications (i.e., severe bleeding, CVA). The patient also did not have the need for invasive hemodynamic monitoring, the need for vasopressor or mechanical cardiac support, or supporting evidence for an acute coronary syndrome /myocardial infarction such as elevated cardiac biomarkers. 

As such plan criteria for an inpatient level of care were not met. In the setting of this case an acute inpatient level hospitalization has not been established as standard of care towards improved cardiac outcomes.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ulcerative colitis
Treatment: Antibody levels of vedolizumab
The insurer denied antibody levels of vedolizumab.
The determination is upheld.

This patient has ulcerative colitis managed with Entyvio. The medical records provided do not indicate a rationale for therapeutic drug monitoring in this patient who was doing well on Entyvio. At issue is the medical necessity of antibody levels of vedolizumab.

The requested health service/treatment of antibody levels of vedolizumab is not medically necessary for this patient.

There are insufficient data to do routine therapeutic drug monitoring in patients with inflammatory bowel disease (IBD) particularly in patients who are not on antitumor necrosis factor (TNF) therapy.

While therapeutic levels of infliximab and adalimumab are well established in the medical literature, there are less data on appropriate therapeutic levels of vedolizumab and ustekinumab since these medications have been available for only a few years as opposed to nearly two decades for the anti TNF agents. At this time, there are still no studies comparing either proactive or reactive therapeutic drug monitoring (TDM) with empiric vedolizumab optimization. Therefore, although there are emerging data that may show an association between drug concentrations and outcomes, they are not sufficient to guide specific induction and maintenance drug concentrations for vedolizumab and ustekinumab other than confirming that there is detectable drug.
Data on reactive Therapeutic Drug monitoring for vedolizumab are scarce.
Where optimal cut-off values have been proposed for the different anti-tumor necrosis factors [TNF]-alpha agents, this is at the moment less clear for vedolizumab and ustekinumab. Cut-off values may also be different depending on the desired outcome.
According to current guidelines:
- It is appropriate to order drug/antibody concentration testing for vedolizumab in non-responders at the end of induction.
- It is appropriate to order drug/antibody concentration testing for vedolizumab in patients with confirmed secondary loss of response.
A multicenter prospective observational study identified a vedolizumab trough concentration cutoff of 18 milligrams per milliliter (mg/mL) at week 6 as the only independent variable associated with mucosal healing within the first year of treatment. Currently, there are no studies comparing either proactive or reactive therapeutic drug monitoring with symptom-based vedolizumab optimization.

Therefore, proactive therapeutic drug monitoring of vedolizumab in this patient was not medically necessary.