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

Diagnosis: Very early onset inflammatory bowel disease. 
Treatment: Remicade (infliximab) - procedure code J1745. 
The insurer denied Remicade (infliximab) - procedure code J1745. 
The determination is overturned. 

This is a male patient with a history of very early onset inflammatory bowel disease (VEO-IBD), Crohn's disease. He tried and failed nutritional therapy, corticosteroids and antibiotics. At issue is the medical necessity of the requested service is Remicade (infliximab). 

Remicade is medically necessary due to the lack of better alternatives and adequate literature support for this therapy. This child has a severe case of very early onset inflammatory bowel disease. There are no Food and Drug Administration (FDA) approved treatments for this age group. The current standard of care is to manage VEO-IBD with the available therapies for older age groups (including infliximab). The current peer reviewed literature supports using tumor necrosis factor inhibitors such as infliximab in treating VEO-IBD. 
According to Dipasquale, V. et al:" This is the largest cohort of pediatric inflammatory bowel disease (IBD) patients treated with infliximab biosimilars (IFX-BioS). Real-life data show that IFX-BioS is efficacious in inflammatory bowel disease (IBD) in children, with high percentages of treatment persistence and a low incidence of nonserious adverse events."
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous basivertebral nerve ablation
The insurer denied Intraosseous basivertebral nerve ablation
The determination is overturned.

This is a male patient with a past medical history (PMH) of lower back pain times (x) 10 years with progression over the past few years.  He has done acupuncture, chiropractic, massage and physical therapy (PT) (for years). He has had sacroiliac (SI) joint injections as well as facet and radiofrequency ablation (RFA) injections. He has tried Advil, gabapentin and oxycodone. His Visual Analog Scale (VAS) is 4-10/10 with an average of 7. The pain is in his axial low back. It impacts his sleep, chores, work and leisurely activities. His pain is worsened with rolling, flexion and extension. His exam is notable for pain with flexion. He had magnetic resonance imaging (MRI) which shows severe degenerative disc disease (DDD) at lumbar (L) 4-5 and L5-sacral (S) 1 with reactive endplate bone marrow edema. At issue is whether Intraosseous basivertebral nerve ablation 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 services is likely to be more beneficial than other standard treatment.
The patient has undergone conservative measures over 10 years including modalities, medications and injection therapy without durable benefit. It is reasonable to try the above procedure prior to considering more invasive surgical techniques. If effective, this procedure may be drug sparing for this young patient.
The patient appears to have exhausted other more conservative options. He has evidence of severe DDD with Modic changes on his MRI from a few years ago with concordant findings on history and examination to suggest discogenic pain.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous basivertebral nerve ablation
The insurer denied Intraosseous basivertebral nerve ablation
The determination is upheld.

This is a male patient diagnosed with low back pain. The patient suffers from chronic low back pain and has tried and failed conservative treatment. The provider stated that the patient has tried acupuncture, chiropractic, interventional radiology, massage, and physical therapy, facet injections, home exercise, lumbar epidural injections, radiofrequency ablation and sacroiliac joint injection. Medications have included Advil, gabapentin and oxycodone. Pain ranges from 4-10/10 and nothing has provided sustained relief. The provider states the patient had a magnetic resonance imaging (MRI) scan performed demonstrating mixed Modic type I and II changes at lumbar (L) 4, L5, and sacral (S) 1 vertebral bodies and the provider believes this is the primary cause of the patient's chronic back pain. The provider believes that the patient clearly meets criteria to undergo this procedure.
A progress note indicates the patient with complaints of chronic low back pain ranging from 7-9/10. He has tried and failed injections and therapy. The physical exam revealed painful limited lumbar range of motion, negative straight leg raise bilaterally. It was noted they will proceed with basivertebral nerve ablation. At issue is whether Intraosseous basivertebral nerve ablation 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 Intraosseous Basivertebral Nerve Ablation Procedure (BVN) 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 patient is noted to have a history of chronic back pain that has not responded to conventional conservative treatment. The provider feels that the patient's pain is coming from Modic changes and he was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). There is a lack of high quality studies evaluating the long-term risks and benefits of this procedure. Although some results have been promising, additional studies are needed to establish the safety and efficacy.  This treatment is not currently considered standard of care in the general medical community. There is insufficient evidence in large, long-term studies found in the peer-reviewed medical literature demonstrating this treatment to be either safe or effective or resulting in superior benefits over that of other standard means of treatment. Additional studies are needed to evaluate long-term risks and benefits of this procedure.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous basivertebral nerve ablation
The insurer denied Intraosseous basivertebral nerve ablation
The determination is upheld.

This is a male patient who presented with complaints of chronic axial low back pain. He has had chronic pain most of his adult life. The pain has been getting worse over the last few years. The pain is described as 7 to 9/10. Magnetic resonance imaging (MRI) of the lumbar spine demonstrates severe degenerative disc disease and spondylosis with type I Modic changes at lumbar (L)4/5 and type II Modic changes at L5/sacral (S)1. The suggested diagnosis is chronic axial low back pain likely vertebrogenic in nature. At issue is whether Intraosseous basivertebral nerve ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

According to guidelines and cited references, despite promising early reports, further trials with longer-term outcomes and less risk of bias are required. There should be at least 6 months of chronic low back pain following a defined injury, refractory to conservative care, as well as Modic type I or II changes between L3 and S1 on magnetic resonance imaging.
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 and one randomized controlled trial.
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 and one randomized controlled trial. These studies have not demonstrated long-term improvements in patient health outcomes, including pain and disability measures. In addition, no United States (U.S.) guidelines based on research recommend this treatment.
The proposed health service or treatment Intraosseous basivertebral nerve ablation 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: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: Intracept procedure
The insurer denied Intracept procedure.
The determination is upheld.

This is a female patient with complaints of chronic axial low back pain. She has tried epidural steroid injections which did not help. She has tried heat, chiropractic treatments, physical therapy. The physical examination of the lumbar spine shows normal shape and contour, palpation is nontender, straight leg raise negative bilaterally, facet joint loading sign is positive in the spine. Magnetic resonance imaging (MRI) of the lumbar spine shows Modic type II end plate changes at lumbar (L) 3/4 as well as L4/5. The diagnosis is lumbar spondylosis. At issue is whether the 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.
According to Becker, et.al : "Seventeen patients with chronic, greater than 6 months, low back pain unresponsive to at least 3 months of conservative care were enrolled. Sixteen patients were treated successfully following screening using magnetic resonance imaging finding of Modic type I or II changes and positive confirmatory discography to determine the affected levels. The treated population consisted of eight male and eight female patients; the mean age was 48 years (34-66 years)."
Current evidence on the use of intraosseous radiofrequency ablation of the basivertebral nerve (BVN) (Intracept) as a treatment of low back pain is limited to a single small observational study and one randomized controlled trial.
As cited above, Becker. et.al trial indicated only a 17 patient observational study.
These studies have not demonstrated long-term improvements in patient health outcomes, including pain and disability measures.
According to Smuck M , et. al " Accordingly, longer-term follow-up may be needed to observe changes in opioid behaviors as demonstrated by a secondary analysis of data from the previous sham-controlled randomized controlled trial (RCT) of BVN ablation that showed opioid reduction in the subgroup reporting improvements in pain during long-term follow-up."
Long term outcomes have not been elucidated demonstrating health outcomes, pain, and disability measures.
In addition, no United States (U.S.) guidelines based on research recommend this treatment. As such, 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.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: Intracept procedure
The insurer denied Intracept procedure.
The determination is upheld.

This is a female patient with complaints of chronic low back pain. Prior treatment has included conservative care, including chiropractic care, physical therapy, injections, as well as medications. The pain ranges from 7-10 out of 10. The pain significantly impacts activities of daily living (ADLs). Magnetic resonance imaging (MRI) demonstrated Modic type II changes lumbar (L) 3, L4, L5. At issue is whether the 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 patient has complaints of low back pain. There is a request for intraosseous basivertebral nerve ablation. This procedure is not recommended. Despite promising early reports, further trials with longer-term outcomes and less risk of bias are required. A Food and Drug Administration (FDA) investigational device exemption trial examined 225 chronic low back pain patients with type I or II Modic changes who were randomized to the requested procedure or sham treatment, resulting in decreased Oswestry disability index (ODI) of 20.5 and 15.2 points, respectively. The authors noted that these marginally clinically meaningful improvements suggested some potential as a minimally invasive treatment, however, there is lack of data to recommend this procedure as treatment modality. In general, there is lack of substantial support for this procedure, and it is currently not considered standard of care.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: Intracept procedure
The insurer denied Intracept procedure.
The determination is upheld.

This is a female patient who has low back pain with radiating pain into the hips and left lower leg. Her magnetic resonance imaging (MRI) scan revealed Modic 2 changes, disc bulge and facet arthropathy at lumbar (L)3/4, and a left L5/sacral (S) 1 paracentral disc herniation with impingement of left S1 nerve root.
The issue is whether the 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 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 Intracept system was designed to treat low back pain from the vertebral body by ablating basivertebral nerves. This patient has low back pain with radiating pain into the hips and left lower leg. Her MRI showed left L5/S1 paracentral disc herniation with impingement of left S1 nerve root, which is likely a significant pain generator. Truumees's study supported the efficacy of the Intracept procedure for vertebrogenic back pain. However, patients with radicular pain and radiographic evidence of other pain etiologies including disc bulge and facet arthrosis were in the exclusion criteria. (1).
Based on the available medical records and current clinical studies, it is unlikely this patient will benefit from the Intracept procedure.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic Neck and Back Pain

Treatment: Pain management

The insurer denied coverage for pain management

The denial is overturned

This patient has chronic neck and low back pain. The patient has been doing a physician guided home exercise program. The patient has had acupuncture and Chiropractic therapy. The patient's current pain medications include Celebrex and Methocarbamol. The patient's magnetic  resonance imaging (MRI) shows disc herniations at C (cervical) 5-C6, C6-C7 and C7-T (thoracic) 1. The request is for a cervical epidural steroid injection.

The patient's physical exam and imaging correspond to clear pathology that can be ameliorated with a cervical epidural steroid injection.  The patient has failed 3 months of conservative therapy and meets ALL the health plan's criteria.

Conger et al (1) conducted a systematic review and meta-analysis and concluded: "Approximately 50% of patients experience >=50% pain reduction at short- and intermediate-term follow-up after cervical transforaminal epidural steroid injection (CTFESI)."

Manchikanti et al (2) published evidence-based guidelines and found: "Disc herniation: Based on relevant, high-quality fluoroscopically guided epidural injections, with or without steroids, and results of previous systematic reviews, the evidence is Level I for caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections with strong recommendation for long-term effectiveness."

The requested injection is medically reasonable and necessary.

Based on the above, the insurer's denial must be reversed. 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 pain management is substantiated.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: Patent ductus arteriosus

Treatment: Inpatient hospital

The insurer denied coverage for inpatient hospital

The denial is modified

 
Pre-term male infant, birth weight 2020 grams. Pertinent to this denial is that the infant had been exhibiting slow oral (p.o.) feeding with occasional tachypnea and tachycardia. Cardiology identified a large patent ductus arteriosus (PDA) on an echocardiogram. As documented by the Attending Neonatologist, "PDA reported as being larger and increased size of left ventricle, baby reported as feeding slower and occasionally tachycardic. After talking to pediatric cardiology and because boy over 2 weeks old and PDA still large with increased left ventricle (LV), pharmacologic therapy is advised at that point".  Accordingly, treatment with Ibuprofen (to induce medical closure) was initiated. A previously heard murmur was not detectable. The infant's weight was 2385 grams, an increase of 35 grams from prior day. Feeds were increased to 45 milliliters (ml) (all P.O.).  The plan included a repeat echocardiogram. Hematocrit was 28% and iron was adjusted for weight. The infant weighed 2430 grams and was taking full p.o. feeds.  A repeat echocardiogram showed a small, restricted PDA. A circumcision was done, and the patient was discharged.

This was a growing preterm infant who had been symptomatic with a significant PDA and who was completing a course of Ibuprofen in the afternoon. Subsequently, the infant was asymptomatic, taking full feeds, and growing. A repeat echocardiogram that verified a response to Ibuprofen was not done until 3 days after completion of treatment. The reviewer did not find a progress note for the end of the stay.  It appears the infant remained hospitalized over the weekend awaiting an echocardiogram on a Monday that could have been done sooner. Also, it appears the circumcision could have been done sooner. 

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 an inpatient admission is modified. Continued stay for three days is substantiated. Two final days were not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Back Pain.
Treatment: Lumbar spine MRI
The insurer denied Lumbar spine MRI.
The determination is upheld.

This is a female patient with back pain that radiates to the bilateral thighs. She has a family history notable for rheumatoid arthritis. No personal history of inflammatory arthritis is documented. The physical exam was notable for decreased lumbar range of motion. A clinical note  remarks on sacroiliac (SI) joint x-rays showing moderate degenerative joint disease (DJD) of the SI joint and lytic/sclerotic lesion, possibly a cyst. No x-ray report was provided. Magnetic resonance imaging (MRI) of the pelvis demonstrated a lesion in the right (R) superior acetabulum and left (L) iliac bone most consistent with a subcentral cyst. Moderate degenerative disc disease was also noted at lumbar (L) 5/sacral (S) 1 with reactive endplate changes. A clinic note suggests a work-up for sacroiliitis to be performed including laboratory studies. No results were provided. Physical therapy (PT) notes are included. The PT notes indicated a plan for treatment 2 times (x) per week for 6-8 weeks. Only 2 sessions were documented. No other treatments were documented. A review of the information provided suggests that a lumbar MRI was ordered but no clinical notes refer to it, nor is there documentation as to the reasoning behind the order. The medical necessity of the lumbar MRI is the issue under review.
There is no provided documentation to support the medical necessity of a lumbar MRI. This is a patient with low back pain. There is no history provided of lumbar radiculopathy. The physical exam based on PT notes suggests decreased lumbar range of motion. Imaging demonstrates cystic changes near the bilateral SI joints. Clinical notes suggest an ongoing work-up for inflammatory arthritis and sacroiliitis. Treatments to date include 2 PT sessions. No documentation provided indicates a lumbar MRI was ordered, nor the rationale behind its ordering. The provided documentation is limited and does not provide adequate information in order to establish medical necessity for a lumbar MRI.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's disease. 
Treatment: inpatient stay. 
The insurer denied the inpatient stay. 
The health plan's determination is overturned. 

The patient is a female with medical history of Crohn's disease. She presented to the emergency department with abdominal pain, bloody diarrhea, fatigue, and rectal prolapse. Labs showed unremarkable complete blood count and elevated blood urea nitrogen of 25. A Computed tomography scan of the abdomen and pelvis showed terminal ileitis. She was treated with intravenous fluid, Zosyn, and morphine. 

The inpatient hospital admission was medically necessary. The patient presented with symptoms (abdominal pain, bloody diarrhea) and imaging suggestive of Crohn's disease flare. She had significant ongoing symptoms, including persistent abdominal pain, three days after presentation. A Colonoscopy was performed and showed inflammation at the ileocecal valve; she had abdominal pain after the colonoscopy. After her symptoms improved, colonoscopy was performed, and she was tolerating an oral diet, discharge became appropriate.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cervical dystonia.
Treatment: Full hospital admission.
The insurer denied full hospital admission.
The determination is overturned. 

The patient is a female who presented with a left (L) cervical (C)7 radiculopathy including L hand and triceps weakness. Past medical history was significant for baseline cervical dystonia for which she followed with neurology as an outpatient. Pre-operative magnetic resonance imaging (MRI) demonstrated moderate stenosis at C6/7 with compression of the L C7 nerve root. The patient was taken to the operating room (OR) where she underwent a C6/7 anterior cervical discectomy and fusion (ACDF) with iliac crest bone graft (ICBG). One intra-operative drain was placed. Post-operatively, the hospitalist and physical therapy (PT) services were consulted. The patient's pain was controlled with intravenous (IV) followed by oral medications. She reported post-operative nausea which was treated with IV and transdermal medications.
On postoperative day (POD) 1, post-operative x-rays demonstrated acceptable C6/7 ACDF without complication. The patient reported throat discomfort in the settings of baseline cervical dystonia and dizziness. She was slow to progress with PT.
On POD 2, she performed much better with PT and pain was better controlled. She was deemed safe for discharge to home.
At issue is the medical necessity of full hospital admission.

The requested health service/treatment of full hospital admission was medically necessary for this patient.
The standard of care is to perform ACDF surgery as an outpatient. However, inpatient admission after surgery would be considered medically necessary when there is a severe deficit or injury, infection, extensive surgery, acute comorbidities, dysphagia (which was present in this patient), hematoma, dural tear, esophageal perforation, vertebral artery injury, C5 nerve palsy, airway compromise, urinary retention, vocal cord paresis or paralysis.
Given the patient's need to remain past 2 midnights as well as a post-operative need requiring a brief to moderate stay extension, the patient did indeed require to remain in the hospital until POD 2. Given her needs, the patient's care was best provided at the inpatient level of care. Her care could not have been appropriately provided at a lower level of care.
Therefore, the requested health service/treatment of full hospital admission was medically necessary.