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

Diagnosis: Multiple Sclerosis

Treatment: Subacute rehabilitation

The insurer denied coverage for subacute rehabilitation

The denial is upheld 

This is a patient with diagnosed multiple sclerosis and more recently urinary tract infection(s).  The patient's ability to perform activities of daily living (ADLs) and functional mobility has gradually declined.  The patient was admitted (from home) to the skilled nursing facility (SNF).  The patient received physical and occupational therapy.  Under review is the medical necessity for subacute rehabilitation.

The submitted SNF records do not support that the patient continued to be an appropriate candidate for the subacute rehabilitation SNF level of care during the time period under review (1, 2, 3).  The patient presented from home to the skilled nursing facility (SNF).  Upon presentation, the patient required a foley urinary catheter and drainage bag.  The patient's ability to perform activities of daily living and functional mobility ranged from maximal assistance to total dependence.  

Over the next several weeks, the foley catheter was eventually removed, and the patient was able to urinate on their own.  Unfortunately, the patient's ability to perform activities of daily living and functional mobility had demonstrated only limited improvement.  According to the physical therapy notes, the patient was unable to ambulate with or without an assistive device.  The patient required the assistance of 2 people, an Eva support walker and a wheelchair followed close behind; being upright for approximately 15 feet.  The patient also required 2 people to transfer from sitting to standing.  A similar lack of progress was documented by the occupational therapist.  The patient continued to require moderate to maximal assistance for bathing, dressing and toileting activities. Subsequent treatment for the time period under review could have been safely provided at a lower level of care (e.g., long term care or home care with visiting therapy services). There were also no other specific acute medical or complicated nursing issues that warranted continued subacute rehabilitation level of care for the time period under review.  

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 subacute is not substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

Diagnosis: Low back pain

Treatment: Intraosseous basivertebral nerve ablation, procedure code 64628

The insurer denied coverage for intraosseous basivertebral nerve ablation, procedure code 64628

The denial is upheld

This is a patient who suffers from lower back pain due to degenerative disc disease (DDD). The treating provider has requested treatment with intraosseous basivertebral nerve (BVN) ablation, procedure code 64628, which is under review.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. 

Medicare does not have a National Coverage Determination (NCD) specifically for the use of the Intracept procedure in the treatment of chronic low back pain. Local coverage determinations (LCDs) do not exist at this time. Intracept remains a procedure without established efficacy.

Therefore, the request for intraosseous basivertebral nerve ablation, procedure code 64628 is denied.

An industry-sponsored study by Becker et al. (2017) assessed the efficacy of intraosseous BVN ablation, with the Intracept system, in 17 patients with chronic low back pain. Sixteen patients were treated successfully. Self-reported outcome measures were collected prospectively at each follow-up interval. There was a significant decrease in the average Oswestry Disability Index (ODI) at 3 months postoperatively, which was maintained at 12 months. Significant improvement in the visual analog scale (VAS) scores and quality of life were also reported at the 3-month follow-up. This study is limited by small sample size, lack of randomization and control and short-term follow-up.

"Recently, basivertebral nerve (BVN) radiofrequency ablation has been developed for the treatment of chronic low back pain (CLBP) thought to arise from the vertebral body endplates (VEPs). This review describes the relevant neuroanatomy and pathobiology of VEP degeneration and injury, imaging correlates of presumed VEP pain, randomized controlled trials performed, appropriate patient selection, and safety. Anatomic, histological, and clinical evidence supports the concept of the VEP as a source of CLBP and the nociceptive role of the BVN. BVN radiofrequency ablation appears to be an effective treatment for a subset of patients with CLBP and evidence of Modic change types 1 and 2 in the L (lumbar) 3 to S (sacral) 1 VEPs who have failed to respond to conservative treatment. However, all studies performed to date have been industry sponsored, and future non-industry-funded trials will be needed to confirm these results" (Michalik, A. et al. 2021).

In summary, the denial of for intraosseous basivertebral nerve ablation, procedure code 64628 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 not substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2:

Diagnosis: Low back pain

Treatment: Intraosseous basivertebral nerve ablation, procedure code 64628

The insurer denied coverage for intraosseous basivertebral nerve ablation, procedure code 64628

The denial is upheld

This patient has chronic low back pain (CLBP). The patient has had Facet injections, Epidural steroid injections (ESI) and Trigger point injections. The patient has had Physical Therapy (PT).  The patient's medication trials have included Mobic and other non-steroidal anti-inflammatory drugs (NSAIDs).  On magnetic resonance imaging (MRI) the patient has Modic type II changes at L (lumbar) 4-L5.  The request is for radiofrequency ablation (RFA) of the Basivertebral nerves (BVN) at L4 and L5.	

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:

.  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 randomized controlled trials (RCTs) 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 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 of care.

In summary, the denial of for intraosseous basivertebral nerve ablation, procedure code 64628 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: Experimental/Investigational
Decision: Upheld

Reviewer #1:

Diagnosis: Low back pain

Treatment: Intraosseous basivertebral nerve ablation, procedure code 64628

The insurer denied coverage for intraosseous basivertebral nerve ablation, procedure code 64628

The denial is upheld

In assessing whether intraosseous basivertebral nerve (BVN) ablation using the Intracept device is considered more beneficial for this patient than standard treatments or procedures, it is important to know that the publications in peer-reviewed literature to date have been mostly company sponsored, have had methodologic flaws, and were at risk for confirmation bias. UpToDate does not support the use of radiofrequency ablation (RFA) for low back pain. Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria.

While this patient may meet Food and Drug Administration (FDA) and Centers for Medicare and Medicaid (CMS} criteria for use of the Intracept device, there is a lack of high-quality evidence demonstrating long term efficacy or an improvement in net health outcome. Additional high-quality evidence is needed prior to determining whether this would be an effective treatment. There are other evidence-based medications and treatments available to this patient. While the MRI does mention degenerative marrow signal changes, it does not specify at what levels. Furthermore, the MRI also states that there is evidence of multilevel disc desiccation and facet arthropathy, which may be contributing this patient's pain. This Intracept procedure is unlikely to be more beneficial than the standard approaches. Any invasive procedure has risk of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

The supporting publications to date have been mostly company sponsored, have had methodologic flaws, and were at risk for confirmation bias. UpToDate does not support the use of radiofrequency ablation for low back pain. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. The Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient. The denial should be upheld.

In summary, the denial of for intraosseous basivertebral nerve ablation, procedure code 64628 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: Neck Pain

Treatment: Physical therapy (procedure codes 97140 and 97110)

The insurer denied coverage for physical therapy (procedure codes 97140 and 97110)

The denial is upheld 

This is a patient involved in a motor vehicle accident. The patient complained of neck and hip pain. Treatment included physical therapy. The patient's auto insurance benefits were reportedly exhausted and billing was switched to their health insurance.  Physical therapy (procedure codes 97140 and 97110) is currently under review. 

The physical therapy (PT) treatment notes made available for review are inadequate and do not provide sufficient objective clinical information to support the medical necessity of physical therapy for the dates of service under review. The clinical records do not establish the medical necessity of continuing a structured outpatient PT treatment program for the time period under review. According to the physical therapy notes, the patient presented with neck pain complaints as a result of a motor vehicle accident. The patient previously received physical therapy which "did not seem to help." Subsequent physical therapy notes were reviewed. The patient's neck and shoulder pain complaints were much the same compared to the prior assessment. After more than 6 months of treatment, there is a lack of credible documented quantitative functional improvement to support the provided treatment as medically necessary. 

The health plan acted reasonably, with sound medical judgement and in the best interest of the patient. Including but not limited to, the clinical standards of the plan, the information provided concerning the patient, the attending physician's recommendation and applicable generally accepted practice guidelines developed by the federal government, nation or professional medical societies boards and associated were taken into consideration. All decisions are evidenced based. 

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 physical therapy (procedure codes 97140 and 97110) is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Gastroesophageal reflux disease (GERD)

Treatment: Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device [i.e. ("that is"), magnetic band], including cruroplasty when performed [current procedural terminology (CPT) code 43284] and 1 associated inpatient bed day

The insurer denied coverage for laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (i.e., magnetic band), including cruroplasty when performed (CPT code 43284) and 1 associated inpatient bed day.

The denial is upheld.

 
The patient has gastroesophageal reflux disease (GERD) and a short segment of Barrett's esophagus. She underwent a gastric sleeve procedure and since then her reflux symptoms have worsened. An endoscopy showed a 3 centimeter (cm) hiatus hernia. An esophageal motility study was also done. Proton pump inhibitor (PPI) therapy has not been effective. Her physician is recommending conversion to a Roux-en gastric bypass as well as performing a LINX procedure. The patient has submitted multiple articles from the medical literature documenting the efficacy of the LINX procedure. 

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conducted an updated Safety and Effectiveness Analysis of the Linx Reflux Management System in March 2017. With regards to safety, the conclusion was that long-term follow-up supports the Food and Drug Administration (FDA) conclusion that the device is safe. With regards to efficacy, there were several conclusions. The LINX implant results in potential of hydrogen (pH) normalization, improved quality of life, and cessation of regular PPI use on a consistent basis. When compared to laparoscopic fundoplication, rates of success in alleviating GERD symptoms and dysphagia are similar following LINX. The long term follow up data demonstrates that the LINX Reflux Management System is effective in the management of GERD. 

This patient has chronic GERD and there is a concern that the gastric sleeve has made the symptoms worse. Doing the LINX procedure has been shown in the medical literature to be both safe and effective. However, in this case the physician notes that there is consideration to taking down the gastric sleeve. According to the Up To Date article, doing the bypass surgery has been shown to help control reflux symptoms which can be a complication of the gastric sleeve. Due to the lack of documentation about the planned roux en y gastric bypass (RYGB) and how this may affect the GERD, the LINX procedure is 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, with sound medical judgment, and in the best interest of the patient. 

The medical necessity for laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device [i.e. ("that is"), magnetic band], including cruroplasty when performed [current procedural terminology (CPT) code 43284] and 1 associated inpatient bed day is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: obstructive sleep apnea

Treatment: durable medical equipment; breathing machine (E0466RR x3)

The insurer denied coverage for durable medical equipment; breathing machine (E0466RR x3)

The denial is overturned
 

The patient has severe apnea hypopnea index (AHI) 46 even after a tonsillectomy and adenoidectomy (T&A). An Ear Nose & Throat (ENT) evaluation was done and the ENT observed that adenoids and tonsils were not growing back. The reason for the obstructive sleep apnea (OSA) even after the T&A is glossoptosis and pharyngeal collapse. For this, continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) is needed. The physician has recommended either CPAP or NIV. Hence, CPAP can be approved. Left untreated, the patient is at risk of excessive day time sleepiness, developmental delay, attention deficit hyperactivity disorder (ADHD), psychiatric disorders, cardiovascular events, stroke and pulmonary hypertension. The appropriate use of CPAP will decrease future healthcare utilization. Hence the requested CPAP 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 durable medical equipment; breathing machine (E0466RR x3) is substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous Basivertebral Nerve Ablation (procedure code 64628, 64629)
The insurer denied: Intraosseous Basivertebral Nerve Ablation 
(procedure code 64628, 64629)
The denial is upheld.

The patient is an adult male with mid back and low back pain radiating down the right leg that began many years ago. Past treatments include acupuncture, chiropractor care, home exercise, lumbar epidural steroid injections, physical therapy, and non-steroidal anti-inflammatory drugs (NSAIDs). The patient's pain is 9/10, and Oswestry Index is 48%. Magnetic resonance imaging (MRI) of the lumbar spine shows a 3-millimeter right disc protrusion with contact of the descending right L5 nerve root and disc degeneration from L4-S1. The request for Intracept was denied coverage by the health plan as experimental/investigational. The denial is being appealed.

The health plan should not cover the requested health service.

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 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 health service.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous Basivertebral Nerve Ablation (procedure code 64628, 64629)
The insurer denied: Intraosseous Basivertebral Nerve Ablation 
(procedure code 64628, 64629)
The denial is upheld.

The patient is an adult male. The appeals letter noted that the patient has a history of chronic low back pain due to development of vertebrogenic pain identified by degenerative endplate changes noted as Modic on magnetic resonance imaging (MRI). The patient's pain had failed treatment for greater than six months. Prior treatments included acupuncture, chiropractic care, home exercise, epidural steroid injection, medication, and physical therapy. The pain was averaging 9/10.
Five months ago, the patient presented for an evaluation for low back pain. It was noted that the patient had mid to lower back pain that occurred many years prior. Pain was aggravated with walking and standing. Diagnosis includes vertebrogenic low back pain.

The health plan should not cover the requested health service.

Based on the documentation and the imaging reports provided, the requested procedure is not recommended in this case. Although the patient has a history of continued pain, there was a lack of any findings noted on magnetic resonance imaging. Despite what is noted in the appeal letter, there was no documentation of any Modic type changes that would support the procedure. As such, it is not recommended in this case. Therefore, the health plan should not cover the requested health service.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Anxiety/depression
Treatment: Home health care
The insurer denied 40 hours per week of Consumer Directed Personal Assistance Services (CDPAS.)
The health plan's determination is upheld. 

This is a female patient with a history of anxiety, depression, bipolar disorder, schizophrenia, post-traumatic stress disorder (PTSD), low back pain, and migraines. The patient lives alone in an apartment. The patient and her care team requested Consumer Directed Personal Assistance Services (CDPAS): 40 Hours per Week.

The 40 hours per week of Consumer Directed Personal Assistance Services (CDPAS) are not medically necessary.
There is documentation in the Uniform Assessment System (UAS) of the patient requiring at least limited assistance with tasks of bathing, dressing upper and lower body, meal preparation, housework, shopping, and transportation. These tasks are predictable and can be scheduled during the approved CDPAS hours. The patient was assessed as independent or requiring supervision only for unpredictable and unscheduled tasks of walking, locomotion, transfer toilet, and toilet use. CDPAS cannot be approved solely for safety and supervision and for time in which tasks and assistance with activities of daily living (ADL) is not being performed by the aide. The patient's psychiatrist and therapist state that an increase in aide hours is medically necessary for activities of daily living but does not specify which tasks require assistance. There is insufficient evidence of the medical necessity of increased CDPAS hours for this patient.