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

Diagnosis: Chronic Low Back Pain. 

Treatment: Outpatient surgery 63650 x 2, 63685 x 1. 

The insurer denied coverage for outpatient surgery 63650 x 2, 63685 x 1. 

The denial is overturned. 

This patient has chronic low back pain. The patient's medication trials have included Hydrocodone/Acetaminophen, Mobic, Naproxen, morphine, cyclobenzaprine and Hemp cream. The patient has had physical therapy (PT). The patient has also had epidural steroid injections (ESI) and radiofrequency ablation (RFA) of the medial branches. The patient's magnetic resonance imaging (MRI) shows multi-level spinal stenosis. The patient has had a psychological evaluation and clearance. The patient had a prior trial of Spinal Cord Stimulation (SCS) more than 6 months ago which produced more than 50% pain relief. The health plan denied the request for permanent implantation because the trial was conducted more than 6 months ago. The trial was repeated and again the pain relief was greater than 50%. The request is for permanent placement. 

Patel et al. (1) conducted a "review of current research, which demonstrates there is a positive role for the current conservative therapies, with favorable results for interventions such as minimally invasive decompression and Spinal Cord Stimulation." 

Similarly, Awad et al. (2) conducted a retrospective review and concluded: 

"With modern SCS techniques, the majority of patients can achieve sustained
improvement of symptoms of neurogenic claudication (NC) of at least a 2-year duration regardless of previous history of lumbar decompressive surgery. SCS can be considered as part of the conservative treatment options before committing to surgical decompression." 

The procedure is medically reasonable and necessary for this patient. 

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 outpatient surgery 63650 x 2, 63685 x 1 is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Gastric ulcerations
Treatment: Esophagogastroduodenoscopy (procedure code 43239)
The insurer denied coverage for: Esophagogastroduodenoscopy (procedure code 43239)
The denial is:
The patient had a previous endoscopy and was found to have gastric ulcerations. The patient had been treated with a proton pump inhibitor (PPI) and the symptoms resolved. An upper gastrointestinal (GI) endoscopy was advised to evaluate for healing of the gastric ulcerations. No residual ulcers or erosions were found. 

Milliman Care Guidelines (MCG) guideline A-0203 lists clinical indications to perform an Upper GI Endoscopy. A gastric ulcer is an indication for the procedure if there is dysplasia on the initial biopsy, family history of gastric cancer, the initial endoscopy was suspicious for a malignancy, the upper GI series was suspicious for malignancy, or if the ulcer is not associated with non-steroidal anti-inflammatory drugs (NSAID) usage. In this case, there is no documentation of any concern on the previous endoscopy of a mass or suspicion of malignancy. The submitted record does not indicate whether the patient was taking or not taking NSAIDs prior to the initial endoscopy. In addition, the description of the stomach on esophagogastroduodenoscopy (EGD) is of ulcerations which suggest that they are shallow and likely inflammatory rather than deeper ulcers. 

UpToDate has an article titled "Overview of upper gastrointestinal endoscopy." Indications for the procedure are listed when performed as a diagnostic examination. These include having upper abdominal pain unresponsive to empiric therapy or associated alarm symptoms, dysphagia, or recent upper GI bleeding. The patient did not have these conditions. 

UpToDate has an article titled "Peptic ulcer disease: Treatment and secondary prevention." The article states that we suggest a surveillance endoscopy after 8-12 weeks in patients with gastric ulcers if the patient remains symptomatic on treatment, there is an unclear etiology, an ulcer over 2 centimeters (cm), if biopsies were not performed on the original endoscopy, or if there is a high suspicion that a gastric malignancy may be present. The patient did not have these conditions.

This patient had ulcerations in the stomach that responded well to PPI treatment, and was no longer symptomatic. The patient did not meet criteria for endoscopy under MCG or UpToDate guidelines. The health care plan acted reasonably and with sound medical judgment. An esophagogastroduodenoscopy was not medically necessary. The denial is upheld.

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 an esophagogastroduodenoscopy (procedure code 43239) is not substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain. 
Treatment: 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 
The insurer denied 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 
The health plan's determination is upheld. 

The patient is a male with complaints of low back pain. The pain began 5 years ago. His prior treatments have included home exercises, injections, as well as multiple medications. Pain ranges from 5-7 out of 10. The pain significantly impacts his activities of daily living. Magnetic resonance imaging (MRI) of the lumbar spine reported Modic type I changes at L (lumbar) 3-4 and L4-5. 

The proposed Thermal destruction of intraosseous basivertebral nerve is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 
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. 
Given the above, the proposed Thermal destruction of intraosseous basivertebral nerve 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: 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 
The insurer denied 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 
The health plan's determination is upheld. 

This is a male patient diagnosed with Vertebrogenic Low Back Pain. Records show that the patient was recommended to undergo Thermal destruction of intraosseous basivertebral nerve (Intracept procedure). 

Intraosseous Basivertebral Nerve Ablation 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 is noted to have a history of chronic back pain that has not responded to conventional conservative treatment. The provider states that the patient has Modic type I changes at disc spaces L (lumbar) 3 - L4 and L4 - L5, although the magnetic resonance imaging (MRI) showed Modic changes at L2-L3 and L4 - L5, noted to be mild at L4 and L5. However, the recent progress note states that the patient was status post lumbar radiofrequency ablation to bilateral L3 - L5 since the last visit and is reporting 95% improvement in axial back pain and currently had a pain level of 1/10, which would suggest that the facet joints are primary pain generator rather than Modic changes. 

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: Back pain. 
Treatment: 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 
The insurer denied 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 
The health plan's determination is overturned. 

This patient is a male who has low back and neck pain. The low back pain is intermittent and dull with no radicular symptoms. Pain level is 7/10. His pain is increased by prolonged sitting, standing and lifting. His prior treatments include pain medications (gabapentin), home exercise, a lumbar nerve block and bilateral L (lumbar)3 to L5 radiofrequency ablation (RFA). Physical exam (PE) showed negative straight leg raise (SLR), negative facet loading tests, lumbar paraspinal tenderness. Magnetic resonance imaging (MRI) showed Modic endplate changes at L2/3 and L4/5 with multilevel disc bulges. 

Thermal destruction of intraosseous basivertebral nerve 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 system was designed to treat low back pain from vertebral body by ablating basivertebral nerves. There are multiple clinical trials demonstrated the sustained improvements in pain and function from this intervention for patients with vertebrogenic pain. This patient has severe despite prior treatments including pain medications (gabapentin), home exercise, a lumbar nerve block and bilateral L3 to L5 radiofrequency ablation (RFA). His symptoms are consistent with vertebrogenic pain. Further interventions are necessary to improve his pain and function. Other potential treatment options are long-term use of medications (non-steroidal anti-inflammatory drugs (NSAIDs), opioids) and lumbar decompression fusion surgery. However, none of these options has a high success rate, and all of them carry significant risks and complications. Given this clinical scenario, the Intracept procedure is likely to be more beneficial than any standard treatments for the insured's condition.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obesity
Treatment: Wegovy 0.25 milligram (mg) / 0.5 milliliter (ml) pen injector
The insurer denied coverage for: Wegovy 0.25 milligram (mg) / 0.5 milliliter (ml) pen injector
The denial is: Overturned
The patient has obesity and has tried a weight loss program and Optavia. The patient has been exercising but has not been able to lose weight. The patient's physician prescribed Wegovy during a visit. The patient's body mass index (BMI) at that time was calculated at 29.99. There is a follow-up visit where BMI is listed as 30.21. 

UpToDate has an article titled "Obesity in Adults: Drug Therapy." The article states that a number of medications are approved by the Food and Drug Administration (FDA) for the treatment of obesity in conjunction with healthy eating, physical activity, and behavior modification. Candidates for drug therapy include those with a BMI of 30 or over or a BMI over 27 with related comorbidities. Semaglutide is a glucagon-like peptide-1 (GLP-1) agonist that is approved for the treatment of obesity. It has demonstrated efficacy in weight reduction, as well as improvement in glycemia and lipids. It has also demonstrated cardiovascular benefits. 

An article in JAMA 2021;325(14):1414-1425 is titled "Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults with Overweight or Obesity." 803 participants in this study were randomized to either continue Semaglutide or to take a placebo after 20 weeks of Semaglutide treatment. Those who continued the treatment with Semaglutide had ongoing weight loss, a better lipid profile, improved glucose metabolism, better blood pressure control, and physical functioning scores. The group who took the placebo regained their weight. The article states that the result of this study emphasizes the chronicity of obesity and the need for treatments that can maintain and maximize weight loss. 

This patient has a BMI of 30.21. Wegovy is a FDA approved treatment for obesity in patients with a BMI of 30 or over. The medical literature supports the beneficial effects of Semaglutide or liraglutide in achieving weight loss in obese patients. If Wegovy is not available, then Saxenda is also a drug that is indicated for obese adults with a BMI of 30 or greater. Wegovy is a medically necessary treatment. 

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 Wegovy 0.25 milligram (mg) / 0.5 milliliter (ml) pen injector is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dental Disorder
Treatment: Braces and monthly visits
The insurer denied braces and monthly visits.
The determination is upheld.

This is a female patient with Class I skeletal and Class II cuspids, mild maxillary crowding and mild mandibular crowding, moderate overjet, and mild overbite with an anterior crossbite. At issue is the medical necessity of braces and monthly visits are medically necessary.
Using the Handicapping Labio-Lingual Deviation (HLD) index, the malocclusion would score an 8 with no auto qualifiers. Auto qualifiers include cleft palate deformity or cranio-facial anomaly, deep impinging overbite with severe soft tissue damage, impacted permanent anteriors where extraction is not indicated, anterior crossbite causing clinical attachment loss and recession of the gingival margin, severe traumatic deviations, overjet 9 millimeters (mm) or greater and underbite 3.5 mm or greater. The case requires a score of 26 or more for treatment to be considered medically necessary. The malocclusion in question does not meet the criteria to be classified as handicapping and treatment would not be considered medically necessary. Thus, according to the standard of care, the requested health service/treatment for braces and monthly visits is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Low pack pain

Treatment: intraosseous ablation of the basivertebral nerve, code 64628

The insurer denied coverage for intraosseous ablation of the basivertebral nerve, code 64628.

The denial is upheld.

This adult male has chronic low back pain. He has had Physical therapy and Acupuncture. His pain medications have included Decadron, Etodolac, over the counter nonsteroidal anti-inflammatory drugs (OTC NSAIDs) and Medrol Dose pack. His magnetic resonance imaging (MRI) shows Modic changes at lumbar (L) 4-L 5.  It also shows degenerative disc disease at L4-L5 with disc herniation with bilateral foraminal impingement. The request is for radiofrequency ablation (RFA) of the Basivertebral nerves (BVN) at 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. (3) 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."

Similarly, a clinical practice guideline (4) while favorable pointed out the limitations of the current literature:

1) Industry funding is a potential source of study bias for the available data reviewed.
2) Limited number of studies.
3) Short-term follow up for the majority of studied patients.
4) Unknown effect on the primary degenerative process
Urits et al. (5) also commented on the need for more research on this promising technique:  "Reproducible large RCTs (randomized controlled trials) are still needed for clinicians to gain full confidence in utilizing this treatment in practice. Additionally, further research is needed on the anatomy of the vertebrae to optimize the method of treatment. These studies can help to elucidate the role of RF (radiofrequency) ablation in the management of chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

In sum, this procedure is not likely to be more beneficial than the standard of care.

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 intraosseous ablation of the basivertebral nerve, code 64628 is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: atopic dermatitis
Treatment: Dupixent
The insurer denied Dupixent. 
The health plan's determination is upheld. 

The patient is a male with psoriasis and atopic dermatitis. He also has psoriatic arthritis. He has tried and failed Excimer, Otezla, Tremfya, methotrexate, acitretin, Siliq and Taltz. He has also been on Skyrizi and Sotyktu. 

Dupixent is not medically necessary for this patient. According to the American Academy of Dermatology Atopic Dermatitis Clinical Guidelines and dermatology literature, the preferred medications covered by the patient's insurance plan, such as tacrolimus ointment, are effective treatments for the management of atopic dermatitis.
A Cochrane Database of Systematic Reviews for Topical tacrolimus (which is a preferred, formulary drug) for atopic dermatitis concluded that "In summary, tacrolimus ointment seems to be safe and effective for moderate to severe atopic dermatitis in children and adults".
It is noted that the patient has tried and failed methotrexate. However, the patient has no true contraindications to the other preferred, formulary medications which have been shown to be effective for the treatment of atopic dermatitis. The preferred agents, such as tacrolimus ointment, are appropriate agents for the treatment of the patient's atopic dermatitis. The formulary medications should be tried and failed prior to initiating Dupixent. Therefore, Dupixent is not medically necessary for this patient based on the evidence-based literature.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Thyroid cancer
Treatment: Tirosint 
The insurer denied Tirosint. 
The health plan's determination is overturned. 

This is a female diagnosed with post-surgical hypothyroidism. This request is for Tirosint. As reported, she has metastatic thyroid cancer status/post (s/p) total thyroidectomy. She had significant side effects to levothyroxine, Synthroid, Levoxyl, Unithroid and Liothyronine (headaches, nausea/ vomiting). The patient has only been able to tolerate Tirosint and has been tolerating it for over a year.

Tirosint is medically necessary.
Tirosint is a brand name of levothyroxine. Levothyroxine capsules are a generic formulation for Tirosint. The patient is reported to have hypothyroidism. Tirosint is Food and Drug Administration (FDA) approved for the treatment of hypothyroidism.
The patient is reported to have failed levothyroxine, Synthroid, Levoxyl, Unithroid and Liothyronine due to severe side effects including headaches, nausea/ vomiting. The patient has only been able to tolerate Tirosint and has been tolerating it for over a year. Therefore, the use of Tirosint is indicated for this patient.