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

Diagnosis: Malocclusion
Treatment: D8080 braces, D8670 monthly visits times (x) 12
The insurer denied coverage for D8080 braces, D8670 monthly visits x 12.
The denial is upheld. 

Upon review of the submitted documentation including lateral cephalometric radiograph, panoramic radiograph, montage of extraoral and intraoral clinical images, as well as insurer correspondence, it appears that this patient presented for evaluation for orthodontic care. The orthodontist recommended comprehensive orthodontics due to impacted permanent anterior teeth among other findings. The orthodontist has completed the Handicapping Labiolingual Deviation (HLD) index as required and has chosen the automatically qualifying condition of impacted permanent anteriors where extraction is not indicated. The insurer has denied coverage for orthodontic treatment as not medically necessary as the clinical circumstance does not meet the required handicapping malocclusion medical necessity requirements on the HLD index, attaining only 18 points on review by internal reviewers. The orthodontist is appealing on behalf of the patient.

To assess for severity of the malocclusion and therefore medical/dental necessity for orthodontic care, an HLD index is utilized. This index provides six specific conditions that automatically qualify for orthodontic care. Additional criteria are used, utilizing a point system if none of these initial qualifying conditions are met or selected. For these other secondary criteria to qualify for orthodontic care, a total score of 26 points is necessary. 

In this case, the treating orthodontist claims an automatic qualifying condition of impacted permanent anteriors where extraction is not indicated. This reviewer finds this criterion is not met and the HLD index attains 18 points, which is below the threshold of 26 or more points which is necessary for approval of orthodontic care. 

Regarding the validity of the HLD index, it has been shown through scientific scrutiny in peer reviewed journals that this methodology for assessing orthodontic need is a valid approach. Each of these peer reviewed articles concludes that this index is a valid and reliable determinant of need for orthodontic care. As this is an accepted methodology, this has been determined to represent an appropriate approach for assessing orthodontic need. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably, with sound medical judgment and in the best interest of the patient. The medical necessity for D8080 braces, D8670 monthly visits times (x) 12 is not substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer # 3

Diagnosis: Low back pain

Treatment: Procedure to treat low back pain (procedure codes 64628 & 64629)

The insurer denied coverage for procedure to treat low back pain (procedure
codes 64628 & 64629)

The denial is overturned

The patient has been diagnosed with low back pain due to osteoarthritis (OA)  lumbar vertebrae (L)4 through sacral vertebrae (S)(1). A magnetic resonance imaging (MRI) shows Modic changes at L4-S1. The patient has tried and failed non-operative management, such as physical therapy (PT), oral medications, and injection management, The treating provider has recommended Intracept procedure (codes 64628 & 64629), which is under review.

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes.

Two-year follow-ups reported with positive results.

Per Becker, S., Hadjipavlou, A., & Heggeness, M. H. (2017), "Ablation of the basivertebral nerve (BVN) for the treatment of chronic lumbar back pain significantly improves patients' self-reported outcome early in the follow-up period; the improvement persisted throughout the 1-year study period."

Per Nwosu, M., et al., (2023), "nerve radiofrequency ablation, among other criteria, is a safe and minimally invasive therapy that significantly lowers pain and impairment in individuals with vertebrogenic pain with distinct Modic type 1 and 2 changes at lumbar vertebra three through sacral vertebra one (L3-S1) vertebral levels."

Per Schnapp, W., Martiatu, K., & Delcroix, G. J. (2023), "Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of chronic low back pain that can be successfully implemented in a community practice setting."      

The procedure to treat low back pain (procedure codes 64628 & 64629) has final approval from the appropriate regulatory bodies for this diagnosis.

The Intracept procedure has been Food and Drug Administration approved (FDA) approved since 2016.     

This patient is a good candidate for this procedure to treat low back pain (procedure codes 64628 & 64629)

There was a failure all appropriate non-operative management; Modic changes noted by magnetic resonance imaging (MRI) scan and axial back pain is the issue.     

Procedure to treat low back pain (procedure codes 64628 & 64629) is the best available treatment for this patient at this time.

All other management has failed, and the patient is not a fusion candidate at this time.     

In summary, the denial of procedure to treat low back pain (procedure codes 64628 & 64629) and coverage for the requested treatment should be overturned. 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

Reviewer #2:

Diagnosis: Low back pain

Treatment: Procedure to treat low back pain (procedure codes 64628 & 64629)

The insurer denied coverage for procedure to treat low back pain (procedure
codes 64628 & 64629)

The denial is upheld

The Intracept procedure is "intraosseous ablation of the basivertebral nerve". It has been proposed to address low back pain identified by Modic changes.  The procedure is performed within the vertebral body. It has been proposed that pain relief is manifested by patients no longer requiring their narcotics. For one level of disc disease each vertebral body requires precise targeting. The operation is not recognized by practicing neurosurgeons or spine surgeon. There are no National Organizations which provide guidelines or indications. 

The peer reviewed publications to date are unclear. There are several studies however no conclusions can be made. No definite statements or guidelines showing  definitive efficacy have been reported. Recent references recommend additional high-level studies to be completed. 

Food and Drug Administration (FDA) approval had been granted for Pre-Market approval. The FDA does not provide statements regarding benefit.

In this case, there is lack of a defined pain generator. It is extremely important to recognize the clinical condition is consistent for radiculopathy. There is sensory loss in a dermatomal distribution. There is normal motion. There are imaging studies showing nerve root compression. This cannot be discounted. It would be more than likely current symptoms are secondary to long standing disc disease and degeneration. It would not be likely the current pain is secondary to the vertebrogenic etiology. The records show use of epidural steroid injections (ESI) and improvement 90-100%. This would not be found if the basivertebral nerve was causing pain. 

There should be consideration for future injections versus evaluation by a surgeon. 

The procedure is invasive. There have been reported complications of infection, broken hardware, endplate fracture and retroperitoneal hematoma.

The requested service is NOT likely to be more beneficial than any of the standard treatment/procedures. 

In summary, the denial of procedure to treat low back pain (procedure codes 64628 & 64629) and coverage for the requested treatment 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: Experimental/Investigational
Decision: Upheld

Reviewer #1:

Diagnosis: Low back pain

Treatment: Procedure to treat low back pain (procedure codes 64628 & 64629)

The insurer denied coverage for procedure to treat low back pain (procedure
codes 64628 & 64629)

The denial is upheld

This patient has chronic low back pain. She has had Physical Therapy and is doing a Home Exercise program. She had an Epidural Steroid injection. Her medication trials have included Gabapentin, Motrin, Tramadol and Tylenol. Her magnetic resonance imaging (MRI) shows a 3 millimeter (mm) Left disc protrusion at lumbar (L)5-sacral (S)1 abutting the Left S1 nerve root.  She also has an annular fissure at L3-L4 as well as Modic Type 1 changes at L4, L5 and S1.  The request is for radiofrequency ablation (RFA) of the Basivertebral nerves (BVN) at L4, L5 and S1. There is no surgical consultation submitted for review.	

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 basivertebral nerve (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:

  Industry funding is a potential source of study bias for the available data reviewed.
 Limited number of studies.
  Short-term follow up for the majority of studied patients.
  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 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 ablation in the management of chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

This procedure is NOT likely to be more beneficial than the standard evidence-based therapies.

In summary, the denial of procedure to treat low back pain (procedure codes 64628 & 64629) and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Multiple skin infections and cellulitis
Treatment: Surgery (outpatient procedure 15830 x1, 15847 x1, 15877 x 1)
The insurer denied: Surgery (outpatient procedure 15830 x1, 15847 x1, 15877 x 1)
The denial is upheld.

The patient is an adult female. According to the surgeon appeal letter, the patient has been working on weight loss and has lost 146 pounds to date after a gastric bypass 9 years ago. The patient develops multiple infections and intertrigo due to the moisture and infections under the skin. She has been at her current weight for years. She is suffering from multiple skin infections as well as cellulitis for the past 6 months with no help from antibiotics. She has been prescribed more than two 10-day courses of antibiotics to no avail. These only give her issues with UTIs (urinary tract infections). She was prescribed Nystatin for the rashes and skin ulcerations. She develops cellulitis and Leukocytosis. Even after using powders, there is still an odor due to the moisture under the skin. Her primary care provider has also advised she take over-the-counter pain medication for the back pain. She goes to Pain Management due to the back pain being so severe, but this is not helping with the constant pain. Her skin has recently opened up with sores due to the moisture and heat. This is causing her functional deficits with her everyday activities. She has a hard time getting clothes to fit properly due to the excess fat in the abdominal area. This is causing depression and anxiety and has been prescribed medication for that as well. The following codes are requested: 15830 x1, 15847 x1, 15877 x 1.

The requested health service is not medically necessary.

The surgeon's note indicates the following: "She has been at her current weight for years. She is suffering from multiple skin infections as well as cellulitis for the past 6 months with no help from antibiotics. She has been prescribed more than two 10-day courses of antibiotics to no avail. These only give her issues with UTIs [urinary tract infections]. She was prescribed Nystatin for the rashes and skin ulcerations. She develops cellulitis and Leukocytosis. Even after using powders, there is still an odor due to the moisture under the skin."
The surgeon's note from last year indicates that the patient plans to lose more weight. It is not clear that her weight has been "stable for years." In addition, the records do not include any notes from the patient's PCP (primary care provider) that document medically supervised care for rashes. The surgeon's appeal letter indicates that the patient has been prescribed Nystatin and antibiotics without improvement, but PCP (primary care provider) notes documenting this treatment are not provided. Moreover, the photos are black and white and do not clearly show rashes. The documentation is not sufficient to confirm medical necessity.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Metastatic Breast Cancer
Treatment: FoundationOne Liquid CDX test
The insurer denied FoundationOne Liquid CDX test.
The determination is overturned.


This is a female patient with metastatic estrogen receptor (ER) positive (+)/human epidermal growth factor receptor (HER) 2 negative (-) breast cancer. Tissue was not available for testing of estrogen receptor (ESR) 1 and Phosphoinositide 3 (PI3) Kinase mutation testing. The FoundationOne Liquid CDX assay was obtained and is under review for medical necessity.

Increasingly, biomarker expression is driving therapeutic decision-making in the treatment of advanced cancer. As noted by the provider, treatment of hormone receptor positive breast cancer in early lines of therapy are, in part, dictated by ESR1 and PI3Kinase mutation testing. ESR1 can only be tested for with next generation sequencing.
The American Society of Clinical Oncology (ASCO) has issued a provisional clinical opinion that supports somatic and germline genomic testing in metastatic or advanced cancer when there are genomic biomarker-linked therapies approved by regulatory agencies for their cancer. These options exist (elacestrant and alpelisib) and have been demonstrated to improve outcomes in eligible patients.
Further, testing for these biomarkers is recommended in the peer-reviewed literature, the National Comprehensive Cancer Network (NCCN), and by the authors of UpToDate. For these reasons, medical necessity has been established for this service.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Low Back Pain
Treatment: Intraosseous Basivertebral Nerve Ablation (64628)
The insurer denied the Intraosseous Basivertebral Nerve Ablation (64628).
The denial is overturned.

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

The patient has failed conservative treatment in the form of physical therapy, epidural steroid injections, RFA (radiofrequency ablation), SI (sacroiliac) joint injections and home exercises. The patient has failed multiple medications including Tramadol, NSAIDs (nonsteroidal anti-inflammatory drugs).

The health plan should cover the Intracept procedure.

The patient is an adult male with chronic low back pain for whom an Intracept procedure has been requested. The procedure was denied coverage by the health plan as experimental/investigational. The patient has failed conservative treatment in the form of physical therapy, epidural steroid injections, RFA, SI joint injections and home exercises. The patient has failed multiple medications including Tramadol, NSAIDs. Magnetic resonance image shows Modic type 2 changes. The patient's physical exam does not reveal any neurological injury. The Intracept procedure (interosseous basivertebral nerve ablation) is not an intradiscal procedure. 

It is a new Food and Drug Administration (FDA) approved intraosseous nerve ablation for the treatment of chronic low back pain in the treatment of vertebrogenic related chronic low back pain. It is typically used in patients with significant Modic type 1 or type 2 vertebral endplate changes, typically in situations where conventional and typical options have been exhausted. The procedure is an FDA approved procedure for axial low back pain. It has been shown effective in randomized clinical trials (RCTs) with five-year results.

Given that this patient has failed all conventional and typical non-surgical options for axial low back pain, the Intracept procedure is medically appropriate. The Intracept procedure should be employed after all conventional and evidence-proven alternatives have failed. Alternatives that remain involve surgery such as instrumented fusion, which does not yield superiority to conservative methods in high-quality RCTs.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Low Back Pain
Treatment: Intraosseous Basivertebral Nerve Ablation (64628)
The insurer denied the Intraosseous Basivertebral Nerve Ablation (64628).
The denial is upheld.

The patient is an adult male with low back pain and left leg numbness. Past treatments include Topamax, tizanidine, Medrol, tramadol, lumbar RFA (radiofrequency ablation), epidural steroid injection at L (lumbar) 3/4, bilateral L4/5 TFESI (Transforaminal Epidural Steroid Injection), Aleve, physical therapy, home exercise program, L5/S (sacral) 1 Intracept 2 years ago, and ice/heat. MRI (magnetic resonance imaging) of the lumbar spine from last year shows nonspecific T1 hypointense/STIR (Short Tau Inversion Recovery)/T2 hyperintense lesions at L5 and S1 vertebral bodies which may represent benign versus malignant etiologies and multilevel moderate to severe degenerative disc and facet disease L4-S1. Recommendation for a dedicated nuclear medicine bone scan was made. The request for L3-5 Intracept was denied as investigational. The denial is being appealed.

The health plan should not cover the requested Intracept procedure.

Review of literature shows moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic back pain who are selected based on Type I or Type II Modic changes as well as other inclusion and exclusion criteria used in published literature to date. However, non-industry funded high-quality, large prospective studies are needed to confirm these findings.

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

Other standard treatment options may include nonopioid medications (i.e. [that is] NSAIDs [nonsteroidal anti-inflammatory drugs], membrane stabilizing agents, and/or muscle relaxants), modalities (i.e. physical therapy, home exercise program, chiropractor treatments), interventions (i.e. epidural steroid injections, medial branch blocks/radiofrequency ablation, spinal cord stimulation, surgical interventions), and/or further diagnostic imaging.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Low Back Pain
Treatment: Intraosseous Basivertebral Nerve Ablation (64628)
The insurer denied the Intraosseous Basivertebral Nerve Ablation (64628).
The denial is overturned.

The patient is an adult male. Per the appeals letter, the patient has a history of chronic low back pain due to degenerative disc disease that resulted in development of vertebrogenic pain identified by degenerative changes (Modic) on MRI (magnetic resonance imaging). The patient has pain and has failed treatment for greater than 6 months. Prior treatments include heat/ice, home exercises, LESI (lumbar epidural steroid injection), MBB (medial branch block), medication management, PT (physical therapy), RFA (radiofrequency ablation) and SIJ (sacroiliac joint) injections. Recently, the patient presented with low back pain and left thigh numbness. The patient has been attending PT for 7 years without relief. The patient had a prior Intracept procedure 2 years ago. The patient's pain increased with walking, bending, standing or twisting and prolonged sitting. The patient's diagnoses include Schmorl's nodes of lumbar region, lumbago, and vertebrogenic low back pain.

The health plan should cover the Intraosseous Basivertebral Nerve Ablation (64628).

Based on the documentation provided, the request is medically appropriate at this time. The patient has a history of chronic low back pain and has tried other treatments and conservative therapy, such as heat/ice, home exercises, LESI, MBB, medication management, PT, RFA, and SIJ injections. Given that the patient continues to be symptomatic with Modic type changes on MRI, the requested procedure is recommended at this time. The procedure has been FDA (United States Food and Drug Administration) approved for a patient with Modic type I and II changes.