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

Diagnosis: Excess skin
Treatment: Excision, Excessive Skin and Subcutaneous Tissue (includes lipectomy); Abdomen Infraumbilical Panniculectomy
The insurer denied: Excision, Excessive Skin and Subcutaneous 
Tissue (includes lipectomy); Abdomen Infraumbilical Panniculectomy
The denial is upheld.

The patient is an adult female. This female complains of musculoskeletal pain and pruritis due to her large breasts. She has shoulder spasms and bra strap grooving. Her surgeon performed bilateral breast reduction, with the removal of 1,162 grams of tissue total. The patient had a gastric sleeve, and she has redundant abdominal skin and fat. She complains of back pain and rashes that have not responded to over-the-counter medications. A letter from her dermatologist documents treatment with topical steroid and anti-fungal creams for rashes.

The requested Excision, Excessive Skin and Subcutaneous Tissue (includes lipectomy); Abdomen Infraumbilical Panniculectomy is not medically necessary.

The letter from the patient's dermatologist notes, "[The patient] was seen for a follow up on her intertrigo located below the breasts and abdominal folds. She was previously prescribed mometasone 0.1 percent (%) ointment BID [twice daily] prn [as needed] and ketoconazole 2% cream BID [twice daily] prn [as needed] and advised to continue this treatment. She was also advised to keep the area cool and dry."
The records do not document any follow-up dermatology visits after the appointment to evaluate the patient's response to treatment. PCP (primary care provider) notes documenting the response to treatment is not provided. Photos do not show rashes. Summary treatment letters and patient appeal testimonies in the absence of physician office note documentation of specific dates of treatments and medications prescribed do not provide sufficient documentation to confirm the 
failure of medically supervised care. According to the American Society of Plastic Surgeons guidelines, "Patients considered for 
panniculectomy should document the type and duration of symptoms/treatment for panniculitis and photographs should confirm the patient's medical condition." The duration and response to treatment are not documented in office notes, and the photos do not show rashes under the patient's pannus.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: Non-obstructive urinary retention
Treatment: Sacral neuromodulation
The insurer denied: Sacral neuromodulation
The denial is partially overturned.

The patient is a teenage female. Her history includes renal/bladder ultrasound demonstrated large bladder capacity and elevated post void residual (about 300cubic centimeters) 2 years ago. The patient was placed on timed voiding. The patient was seen 3 months ago and presented with urinary frequency up to every 30 minutes and leakage of urine if she could not get to the bathroom on time. This persisted despite a trial of oxybutynin 10mg (milligrams) XL (extended release) and 15mg (milligrams) XL (extended release). Two months ago, the patient reported frequency every 45 minutes, straining to void, nocturia 4 to 5 times per night. The patient had a urodynamic study that demonstrated no detrusor overactivity, unable to void with 
bladder filled to 500ml (milliliters). A uroflow prior to the urodynamic study demonstrated voided volume of 548ml (milliliters), extremely elongated flow curve and postvoid residual of 160ml (milliliters). It was recommended that she perform Clean intermittent catheterization, but due to anatomic abnormalities narrow introitus, she was unable to perform clean intermittent catheterization by herself and thus sacral neuromodulation was recommended. The request is for a trial and potentially permanent placement of sacral neuromodulation. The service was denied coverage by the health plan as not medically necessary due to lack of documentation of more than 
50% improvement with trial. The denial is being appealed.

The requested health service is medically necessary, in part.

Specifically, a trial of sacral neuromodulation is medically necessary for this patient, though permanent placement is not medically necessary at this time. The information provided demonstrates that the patient meets the criteria for a trial period of sacral neuromodulation. She has non-obstructive urinary retention, and her symptoms have been present for at 
least 12 months, she has no documented neurologic cause, and she is unable to perform clean intermittent catheterization due to anatomic abnormalities. Thus, the patient meets criteria for a trial of sacral neuromodulation. However, placement of permanent device is not medically necessary at this time, as the patient does not have documentation of response to a trial period.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain. 
Treatment: Procedure (intraosseous basivertebral nerve ablation) to treat low back pain (procedure code 64628). 

The insurer denied coverage for procedure (intraosseous basivertebral nerve ablation) to treat low back pain (procedure code 64628). 

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 surgeons. There are no National Organizations which provide guidelines or indication. 

The procedure is essentially a thermoablation performed within the vertebral body. 
There are several level 1 studies showing the benefit of this procedure up to 2 years after treatment compared to controls. However, all of these studies were either funded by the manufacturer and/or authored by consultants from the manufacturer. No high-quality study exists that does not have a significant conflict of interest with the manufacturer. 

It is important to define the pain generator and exclude other sites of pathology which could be causative. The patient's records show degenerative disc disease (intervertebral disc and not the basivertebral nerve), facet pathology, nerve compression and stenosis. Any one of these or in combination could be responsible for symptoms. A relative contraindication is a treatable surgical lesion. The treating physician reports the Modic changes to several levels but does not report nor discuss the probable etiology of pain. (Disc, facet, stenosis, nerve compression). 

Peer reviewed literature does not support a result of improvement in health outcomes with the requested procedure. 

The requested procedure does have final regulatory approval from the appropriate regulatory bodies for this diagnosis. 

This patient is not a good candidate for the requested procedure.  It is not the best available treatment for this patient at this time. 

In summary, the denial of procedure (intraosseous basivertebral nerve ablation) to treat low back pain (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

Diagnosis: Low back pain. 
Treatment: Procedure (intraosseous basivertebral nerve ablation) to treat low back pain (procedure code 64628). 

The insurer denied coverage for procedure (intraosseous basivertebral nerve ablation) to treat low back pain (procedure code 64628). 

The denial is upheld. 

Patient has a history of chronic lower back pain. There is a preauthorization denial based on the procedure being investigational or experimental. According to documentation patient has a history of longstanding lower back pain and has trialed rest, ice, heat, medication and over-the-counter medication. The patient has had a significant impact on activities of daily living secondary to the pain. Patient had a magnetic resonance imaging (MRI) earlier this year showing Modic changes at lumbar (L)3-L4 L4-L5 L5-sacral (S)1. The physician is attributing the patient's chronic lower back pain to Modic changes in the lumbar spine and recommending an intraosseous basilar vertebral nerve (BVN) ablation. 

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

The procedure (intraosseous basivertebral nerve ablation) to treat low back pain (procedure code 64628) does not final approval from the appropriate regulatory bodies for this diagnosis. 

The patient would not be a good candidate for this procedure. 

This is not the best available treatment. There are other treatments such as injections, surgical care or spinal cord stimulator. 

Risk over standard treatment/services still needs to be investigated. 

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.                    

In summary, the denial of procedure (intraosseous basivertebral nerve ablation) to treat low back pain (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

Diagnosis: Low back pain. 
Treatment: Procedure (intraosseous basivertebral nerve ablation) to treat low back pain (procedure code 64628). 

The insurer denied coverage for procedure (intraosseous basivertebral nerve ablation) to treat low back pain (procedure code 64628). 

The denial is upheld. 

This patient has chronic low back pain after sustaining a compression fracture of lumbar (L)1-L2 after a boating accident. He is taking over the counter (OTC) pain medications. He has had Physical therapy. His magnetic resonance imaging (MRI) shows multi-level disc protrusions with spinal stenosis as well as ligamentum flavum hypertrophy. Modic changes are present at multiple levels.  He has not had any injections, the minimally invasive lumbar decompression (MILD) procedure or other interventions.  The request is for radiofrequency ablation (RFA) of the Basivertebral nerves (BVN). 

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. 

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 radiofrequency (RF) ablation in the management of chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future." 

Peer reviewed literature does not support a result of improvement in health outcomes with the requested procedure. The requested procedure does have final regulatory approval from the appropriate regulatory bodies for this diagnosis. 

This procedure is NOT likely to be more beneficial than the standard therapies.  He has multiple evidence-based therapies available to him. 

In summary, the denial of procedure (intraosseous basivertebral nerve ablation) to treat low back pain (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 increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Severe Asthma
Treatment: Bronchial Thermoplasty (Codes 31660 and 31661)
The insurer denied: Bronchial Thermoplasty (Codes 31660 and 
31661)
The denial is overturned.

The patient is an adult female with severe persistent asthma is being considered for bronchial thermoplasty (BT). The patient has severe persistent asthma that despite aggressive medical treatment and trigger avoidance, it continues to worsen. The patient has had multiple exacerbations in the past. The patient has been on long-acting inhaled corticosteroids, Singulair, and biologics but continues to have worsening asthma symptoms. The bronchial thermoplasty (BT) is denied due to lack of medical appropriateness. This denial is being appealed.

The health plan should cover the proposed treatment.

The patient has severe persistent asthma. The patient has tried and failed current standard asthma treatments which includes high dose long-acting inhaled corticosteroids, Singulair, long-acting beta agonist (LABA), long-acting muscarinic antagonists (LAMA) as well as biologics such as Tezspire. The patient has had multiple asthma exacerbations in the past  months and has needed multiple cycles of oral steroids. Since the patient has tried and failed all current available treatments for severe persistent asthma, the next best option is bronchial thermoplasty. 
Bronchial thermoplasty is effective irrespective of the asthma endotypes and may be associated with airway remodeling. Bronchial thermoplasty therapy is associated with decreases in severe exacerbations, hospitalizations, emergency department visits, and corticosteroid exposure. Bronchial thermoplasty improves asthma control in different asthma phenotypes. Bronchial thermoplasty may be a valuable add-on therapy for the treatment of severe asthma.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain. 
Treatment: Intraosseous basivertebral nerve ablation, procedure codes 64628 and 64629. 
The insurer denied coverage for intraosseous basivertebral nerve ablation, procedure codes 64628 and 64629. 
The denial is upheld. 

According to the medical records, the patient is an adult male with a history of low back pain. He has tried various modalities to address his pain. A magnetic resonance imaging (MRI) of the lumbar spine shows mixed Modic changes at multiple levels throughout the lumbar spine. The treating provider is requesting authorization for Intracept procedure. 

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. 

This procedure does not have final approval from the appropriate regulatory bodies for this diagnosis. There is 510(k) approval of ablation device -- No formal approval of the entire procedure. 

The patient has Modic changes throughout the Lumbar Spine. This patient is not a good candidate for this procedure. 
 
Intracept remains without established efficacy.  It is not the best available treatment for this patient. 

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient. 

In summary, the denial of intraosseous basivertebral nerve ablation, procedure codes 64628 and 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

Diagnosis: Low back pain. 
Treatment: Intraosseous basivertebral nerve ablation, procedure codes 64628 and 64629. 
The insurer denied coverage for intraosseous basivertebral nerve ablation, procedure codes 64628 and 64629. 
The denial is upheld. 

This adult male has a history of chronic low back pain. He has tried: activity modification, caudal epidural steroid injections, heat/ice, home exercises, laminectomy, massage therapy, medication management, and trigger point injections. Medication trials have included: Meloxicam, non-steroidal anti-inflammatory drugs (NSAIDs), Tizanidine, and Tylenol. The pain has had a significant impact upon activities of daily living (ADLs) such as: bending/lifting, sitting, standing, walking, and work. Nothing has provided significant sustainable relief. His condition has been characterized by a Visual Analog Scale (VAS) score between 5/10 and 7/10. He had a magnetic resonance imaging (MRI)  which demonstrated Modic type I and II changes in the lumbar (L)3, L4, L5, sacral (S)1 vertebral bodies and the request is for radiofrequency ablation (RFA) of the Basivertebral nerve (BVN) at those levels. 

The publications to date have been company sponsored and had methodology flaws. 

There is 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: 

- 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. 

This procedure is NOT likely to be more beneficial than the standard of care. 

In summary, the denial of intraosseous basivertebral nerve ablation, procedure codes 64628 and 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

Diagnosis: Vertebrogenic Low Back Pain.
Treatment: Intracept Procedure (64628, 64629).

The insurer denied Intracept Procedure (64628, 64629).  The denial is upheld.

The patient is an adult female. The appeals letter notes that the patient has a history of chronic low back pain due to degenerative disc disease. This resulted in the development of vertebrogenic pain that was identified by degenerative endplate changes known as Modic on magnetic resonance imaging (MRI). The patient had pain for greater than six months and had failed treatment for greater than six months. Prior treatments include home exercise, physical therapy, and transforaminal epidural steroid injections. Five months ago, the patient presented with low back pain. Her pain was noted to be axial. She previously had transforaminal epidural steroid injections that alleviated leg and hip pain. Her pain is rated 2/10. Exam noted there was pain with forward flexion in the axial back.

The health plan should not cover the Intracept procedure.

Based on the documentation provided, the requested procedure is not recommended at this time. Although the patient has a history of chronic low back pain, there was no documentation of all other causes having been ruled out. On magnetic resonance imaging (MRI), it did show Modic type changes. Additionally, there was ligamentum flavum hypertrophy as well as facet arthropathy. None of these indications have been ruled out prior to the requested procedure. As such, the request is not recommended in this case. The Intracept procedure is not more beneficial than any standard treatment for the patient's condition or disease. It was noted that the patient has axial back pain. There was no documentation of all other treatments having been tried to rule out the patient's symptoms. Imaging did show ligamentum flavum hypertrophy, as well as facet arthropathy at the levels being treated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Vertebrogenic Low Back Pain.
Treatment: Intracept Procedure (64628, 64629).

The insurer denied Intracept Procedure (64628, 64629).  The denial is upheld.

The patient is an adult female with low back pain that began more than six months ago. Her past treatments include home exercise, physical therapy, and transforaminal epidural steroid injections. Her pain ranges from 2/10 to 3/10. Magnetic resonance imaging (MRI) of the lumbar spine shows mild central canal stenosis at L (lumbar) 2-3 secondary to disc bulge with ligamentum flavum hypertrophy and facet arthropathy, as well as chronic Modic type 2 changes at L 3-4 and L5-S (sacral) 1. 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 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 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 Intracept procedure.

Additional studies/trials are necessary to determine efficacy as compared to other conventional therapies. The requested health service or treatment has not been proven to be more beneficial than any standard treatment for the patient's condition or disease. Other standard treatment options that exist in the medical literature may include non-opioid medications (i.e., non-steroidal anti-inflammatory drugs [NSAIDs], membrane stabilizing agents, and/or muscle relaxants), modalities (i.e., physical therapy, home exercise program, chiropractor treatments), and interventions (i.e., epidural steroid injections, medial branch blocks/radiofrequency ablation, spinal cord stimulation, and/or surgical interventions).