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

Diagnosis: Endocrine/Metabolic/Nutritional. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Nutropin AQ Inj. 
The denial is overturned.

The patient is a male who is seeking growth hormone (GH) treatment under the indication of idiopathic short stature (ISS). His mother's height is 5' and his father's height is 5' 6''. Limited clinical information is available. His growth chart shows that he was growing just below 3 percentile for height until the age of 11 years after which his height drifted further below the growth chart. With GH, his growth improved, and at a most recent follow up visit, his height was 143.9 centimeter (cm) (0.93 percentile - 2.35 SD) while his weight was 36.4 kilogram (kg). The subject under review is the medical necessity for Nutropin.

The health plan's determination is overturned.

Nutropin is medically necessary for this patient.  With GH treatment, this patient has grown, which gives him a growth velocity of 7.8 cm per year in 15.5 months out of which he was on growth hormone for 10 months. His growth velocity has doubled on GH. As his growth has improved with GH, continuation of growth hormone is medically necessary.
This patient is seeking GH treatment under the indication of ISS. In 2003, the US Food and Drug Administration (FDA) approved injectable somatropin (Humatrope) for the treatment of idiopathic short stature (ISS), also called non-GH-deficient short stature, defined by height SDS less than or equal to (<=) -2.25 and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes of short stature that should be observed or treated by other means.
A meta-analysis of the efficacy of growth hormone treatment in children with idiopathic short stature including 10 controlled trials and 28 uncontrolled trials suggested an average gain in adult height of approximately 4-6 centimeter (cm) from GH treatment.
This patient is quite short for his age and although he is not from tall parents and his mid parental height is only 65.5+/-2 inches, he is even short for his genetics. At his follow up visit, his height was 2.61 standard deviation (SD) below the mean for age and 1.15 SD below his mid parental height. His height had apparently dropped from -2.44 SD to -2.61 SD in about 9 months suggesting that his growth velocity must have been close to 3.7 cm per year in that time frame which is less than expected. He clearly meets the definition of ISS.
The Pediatric Endocrine Society Guidelines for GH and Insulin-Like Growth Factor-1 Treatment in Children and Adolescents recommend GH treatment for ISS on a case-by-case basis after assessment of physical and psychological burdens, and discussion of risks and benefits.
Based on his most recent bone age, this patient's adult height prediction is about 65.9+/-2'' (which is his mid-parental height) provided that he continues to grow at a normal rate. GH treatment should be continued for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hypertension.

Treatment: Inpatient admission.

The insurer denied coverage for inpatient admission.

The denial is overturned.

The patient presented to the hospital with headache and visual changes.  Past medical history was significant for hypertension and diabetes mellitus.  The patient had not taken antihypertensive medications for two weeks.  Blood pressure measured by emergency medical services (EMS) was 280/135mmHg (millimeters of mercury).  Upon arrival to the hospital, blood pressure (BP) was 220/110 and pulse was 71. No other abnormal findings were noted on physical examination.  A 12 lead electrocardiogram revealed normal sinus rhythm with right bundle branch block and left anterior fascicular block. Serum blood testing revealed a creatinine of 1.5.  The patient was treated with intravenous labetalol and admitted to the hospital for treatment.  Head computed tomography (CT) revealed no acute stroke or intracranial hemorrhage.  Blood pressure was eventually controlled, and the patient was transitioned to oral antihypertensive medications. 

Hypertensive emergency is defined as BP> (greater than) 180/120 with target organ damage (Reference 1). This patient had headache and visual changes consistent with target organ damage. Acute renal insufficiency was also noted. The goals of treatment of hypertensive emergency are to minimize progressive or additional target organ damage while preventing consequence of rapid BP correction (Reference 2). Given this patient's failure to respond to initial medical therapy, admission to the hospital for aggressive blood pressure management was necessary. In fact, American Heart Association guidelines recommend admission to the intensive care unit (ICU) for management of hypertensive emergencies (Reference 1). In conclusion, this patient should have been managed at a higher level of care.

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for the inpatient admission is overturned. Medical Necessity is substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Lower Back Pain.

Treatment: 22899, unlisted procedure, spine, Intracept, C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum.

The insurer denied coverage for 22899, unlisted procedure, spine, Intracept, C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum.

The denial is upheld.

This is a female with a history of radiculopathy and osteoarthritis. She had a telemedicine visit with the Pain Management specialist for a follow up regarding lower back pain. The patient has tried physical therapy (PT), injection therapy, pain medications, and chiropractic care. She has tried conservative measures for more than 6 months. Imaging revealed Modic changes at L (lumbar) 3-L4-L5. Her back significantly impairs her ability to perform activities of daily living (ADL). The physician recommended continuing Duexis three times a day (TID) as needed (PRN), continuing PT, and obtaining authorization for the Intracept procedure.

There are randomized controlled trials (RCT) that show its effectiveness at two years. In fact, there is another follow-up study where it was recommended that patients cross over to the treatment arm due to effectiveness early on. 

Intracept is medically indicated in patients who have - A history of low back pain of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - Magnetic resonance imaging (MRI) demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to S (sacral) 1; and - Activities of daily living that are limited by persistent low back pain; and - All other reasonable sources of pain have been ruled out.

Despite a history of chronic low back pain of more than six months, the MRI findings did not point to any evidence of Modic type 1 or type 2 changes at any vertebra, which is a recommended requirement by Relievant, the Intracept Medical device manufacturer. The magnetic resonance imaging report provided specifically states: "Bones: Vertebral body heights are maintained. Marrow signal is within normal limits."

There are other evidence-based procedures available to this patient. This procedure is unlikely to be more beneficial than the standard approaches to disc related back pain.

Any invasive procedure has risk of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

Based on the lack of magnetic resonance imaging findings of Modic changes, the Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient.

The carrier's denial of 22899, unlisted procedure, spine, Intracept, C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Lower Back Pain.

Treatment: 22899, unlisted procedure, spine, Intracept, C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum.

The insurer denied coverage for 22899, unlisted procedure, spine, Intracept, C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum.

The denial is upheld.

The patient is a female with chronic low back pain, radiculopathy and osteoarthritis. She has tried physical therapy (PT), injection therapy, pain medications, and chiropractic care. She has tried conservative measures for months. Imaging revealed Modic changes at L (lumbar) 3-L4-L5. Her back significantly impairs her ability to perform activities of daily living (ADL). Her physician recommended continuing Duexis three times a day (TID) as needed (PRN), continuing PT (physical therapy), and wants to perform the intracept procedure at L3, L4 and L5.

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

In sum, The Intracept procedure is an experimental/ investigational procedure. The publications to date have been company sponsored and had methodology flaws. There is no published data on long term complication rates. UpToDate (3) has evaluated this procedure and concluded that it is still investigational. There are other evidence- based interventions available to this patient. This procedure is unlikely to be more beneficial than the standard approaches.

The carrier's denial of 22899, unlisted procedure, spine, Intracept, C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Lower Back Pain.

Treatment: 22899, unlisted procedure, spine, Intracept, C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum.

The insurer denied coverage for 22899, unlisted procedure, spine, Intracept, C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum.

The denial is upheld.

This is a female with a history of radiculopathy and osteoarthritis. She had a telemedicine visit with the Pain Management specialist for a follow up regarding lower back pain. The patient has tried physical therapy (PT), injection therapy, pain medications, and chiropractic care. She has tried conservative measures for more than 6 months. Imaging revealed Modic changes at L (lumbar) 3-L4-L5. Her back significantly impairs her ability to perform activities of daily living (ADL). The physician recommended continuing Duexis three times a day (TID) as needed (PRN), continuing PT, and obtaining authorization for the Intracept procedure. 

The Intercept procedure is "intraosseous ablation of the basivertebral nerve". It has been proposed to address low back pain identified by Mobic changes. The procedure is performed within the vertebral body. It has been proposed that pain relief is manifested by patients who no longer require their narcotics. For one level of disc disease each vertebral body requires precise targeting. The operation is not recognized by practicing neurosurgeon nor spine surgeon. There are no National Organizations which provide guideline nor indication. 

A search was performed using PubMed. The key word was Intracept Lumbar. There were two references. The articles submitted by appeal were also reviewed. The findings were this procedure is currently investigational/ experimental. There were small numbers of people evaluated for a short duration. The procedure is currently being performed by an investigative group and likely IRB (Investigational Review Board). The procedure is not mainstay nor currently accepted treatment by the practicing medical community. 

The procedure is essentially a thermoablation performed within the vertebral body. 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. The Food and Drug Administration (FDA) has given approval for marketing, but no recommendations have been made for efficacy or standard of care. This patient is not a good candidate for the Intracept procedure. The requested procedure is not the best available treatment for this patient at this time. The adverse risks increased over standard treatment/services is not reported. The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient. 

The carrier's denial of 22899, unlisted procedure, spine, Intracept, C9752, destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum should be upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Weakness
Treatment: personal care assistance
The insurer denied Personal Care Assistance (PCA) Services: 40 Hours per Week. 
The health plan's determination is overturned.

The patient is female with past medical history of hypertension, diabetes mellitus type 2, urinary incontinence, and hypothyroidism who had been assigned PCA (personal care assistant) services. The patient had Covid-19 infection. There was a request to increase PCA services and the patient underwent an assessment via telephone assessing the patient at maximum assistance with tasks of meal preparation, ordinary housework, managing finances, shopping, transportation, and equipment management while extensive assistance with tasks managing medication, stairs, personal hygiene, dressing upper/lower body, walking, locomotion, transfer toilet, and toilet use. The patient was assessed at independent with tasks of bed mobility and eating. The patient's PCP (primary care provider) provided a letter stating the patient needed assistance with bathing, dressing, and all of her instrumental activities of daily living. 

Personal Care Assistance (PCA) Services: 40 Hours per Week are medically necessary for this patient.
The patient has documented functional and cognitive decline since Covid-19 infection. The patient's PCP recommended an increase in PCA services. The patient's daughter is not able to provide informal care 3-6 pm and the plan assumed the patient had informal care outside of the hours she has PCA services. The patient requires assistance with all activities of daily living (ADL)/ Instrumental activities of daily living (IADL) except bed mobility and eating. The patient has unpredictable and unscheduled care needs that span a continuum of time and the insurer failed to document a plan to meet these unpredictable and unscheduled care needs. The patient's care needs cannot be met solely with adaptive equipment and medical supplies. The requested increase in PCA services is not solely for safety supervision but to assist the patient with safe completion of ADLs/IADLs. Taking into account the clinical standards, all information provided regarding the patient, the attending physician's recommendations, and the applicable and generally accepted practice guidelines, PCA services 40 hours/week are medically necessary for this patient. Personal care services are medically necessary when assistance with nutritional and environmental support function is essential to the maintenance of the patient's health and safety in her own home.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Uterine Fibroids
Treatment: Embolization
The insurer denied the Embolization
The denial is overturned

The patient is a female with menorrhagia, anemia, and uterine fibroids.  The request is for a uterine fibroid embolization (UFE), also called a uterine artery embolization (UAE).

Yes, the embolization was medically necessary.

No, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient.
A search of the peer-reviewed medical literature on PubMed.com finds many articles regarding uterine fibroid embolization (UFE) also called uterine artery embolization (UAE). The radiology and gynecology societies recommend this procedure to treat symptomatic uterine fibroids. Uterine fibroid embolization (UFE) is considered standard of care and had been demonstrated to be as efficacious in comparison to surgery. 

A review paper by Bulman, states that "Uterine fibroid embolization (UFE) has become established as an accepted minimally invasive treatment for uterine fibroids and should be considered a treatment option for patients with symptomatic uterine fibroids." 

It is less invasive with improved recovery time in comparison to surgery.  The criteria from the Standards Division of the Society of Interventional Radiology, Patient Care and Uterine Artery Embolization for Leiomyomata, were fulfilled. A pap smear is not necessary prior to a uterine fibroid embolization (UFE) and a normal pap smear was obtained.

The requested uterine fibroid embolization was medically necessary in that it was safe, effective, and within generally accepted national standards of medical practice.  The uterine fibroid embolization was not provided primarily for convenience of the patient or the practitioner, and was the least intensive and/or most appropriate alternatives among diagnostic and treatment options.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Pulmonary Embolism and Deep Vein Thrombosis. 
Treatment: Eliquis. 

The insurer denied the Eliquis. 
The determination is overturned. 

The patient has a history of obesity and presented with a submassive bilateral pulmonary embolism and deep vein thrombosis (DVT) requiring an inferior vena cava (IVC) filter after a retroperitoneal hemorrhage occurred while being treated with intravenous (IV) heparin. The patient subsequently developed a worsening left lower extremity DVT and was started on Lovenox injection, then transitioned to Eliquis (apixaban) 5 milligrams (mg) twice daily at that time. The patient has done well on Eliquis since then, however, has experienced abnormal uterine bleeding. The patient's health plan has denied the apixaban. At issue is whether the formulary drugs warfarin or Xarelto will be or have been ineffective, would not be as effective as the non-formulary drug Eliquis, or would have adverse effects. 

Based on the patient's medical records provided, the formulary anticoagulants warfarin and Xarelto are inappropriate anticoagulants for this patient. The patient requires continued treatment with anticoagulation given her history of DVT and submassive pulmonary embolism. In addition, the patient has experienced significant retroperitoneal bleeding as well as abnormal uterine bleeding since then, making warfarin and Xarelto inappropriate anticoagulants given their higher associated bleeding risk compared to the nonformulary anticoagulant apixaban (1, 2). For this reason, apixaban is the safest and most appropriate anticoagulant for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Gastroesophageal reflux disease.
Treatment: Esophagogastroduodenoscopy or EDG .
The insurer denied Esophagogastroduodenoscopy or EDG.
The determination is upheld.


The patient reports dyspepsia for years and a finding of gastric ulcers on esophagogastroduodenoscopy with endoscopic confirmation of ulcer healing; she had recurrent symptoms. She presented with gastroesophageal reflux disease (GERD) symptoms and epigastric pain. An esophagogastroduodenoscopy showed a normal esophagus, diffuse mild antral gastritis, and normal duodenum (biopsies showed minimal reflux esophagitis, mild chronic inactive gastritis, and normal duodenum); the recommendation was to start a proton pump inhibitor. She has persistent dyspepsia and loss of appetite, and occasional blood in the stool. At issue is the medical necessity for the esophagogastroduodenoscopy (EGD).
The requested procedure is not medically necessary.  Clinical guidelines (including the American College of Gastroenterology guidelines for the treatment of gastroesophageal reflux disease, and guidelines for dyspepsia) recommend endoscopy for investigation of upper gastrointestinal symptoms when those symptoms are refractory to proton pump inhibitor taken properly for 4-8 weeks without response [1-4]. The most recent American Society for Gastrointestinal Endoscopy (ASGE) guidelines for appropriate use of endoscopy state that endoscopy is warranted if an appropriate empirical trial of therapy for a suspected benign digestive disorder has been unsuccessful [3]. Current medical literature continues to support these recommendations [5-8].
In this case, there is no documented proton pump inhibitor therapy for at least 4 weeks before the endoscopy. For these reasons, esophagogastroduodenoscopy with biopsies was not supported in this case.