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

Diagnosis: Dental problems (skeletal Class I malocclusion, class II canines, maxillary and mandibular crowding, posterior crossbite, excessive overjet, blocked out mandibular molars).
Treatment: Braces.
The insurer denied coverage for braces. The denial is overturned. 

This is a female child who presented evaluation for orthodontic care. The orthodontist identified skeletal Class I malocclusion, class II canines, maxillary and mandibular crowding, posterior crossbite, excessive overjet, blocked out mandibular molars and has recommended orthodontics. The orthodontist has completed the Handicapping Labio-Lingual Deviation (HLD) index attaining 28 total points. 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 having attained a score of 16 points on the HLD index.

It is evident that the patient exhibits a significant malocclusion. However, to assess for severity of the malocclusion and therefore medical/dental necessity for orthodontic care, the 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 did not claim an automatic qualifying condition and completed the second portion of the index arriving at 28 points to justify orthodontic care. This reviewer concurs with the index completed by the orthodontist attaining a total of 28 points on the HLD index (4 overjet, 3 overbite, 9 ectopic eruption, 5 anterior crowding, 3 labiolingual spread 4 posterior unilateral crossbite) which is above the threshold of 26 points to support 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.  

Peer reviewed articles conclude 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.

The clinical circumstance as presented does meet and substantiate the medical/dental necessity of orthodontic care. The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

Based on the above, the medical necessity for braces is substantiated. The insurer's denial is overturned.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Paroxysmal atrial fibrillation, Hypertension.
Treatment: Inpatient hospital admission.
The insurer denied coverage for the inpatient hospital admission. The denial is upheld.

This is a male patient who was admitted for an elective atrial fibrillation (AF) ablation. He has a past medical history which is significant for paroxysmal AF, which was noted on an implanted loop recorder, in addition to hypertension. The patient was in AF 40% of the time, sometimes with a rate reaching as high as 200 beats per minute (bpm). The patient complained of occasional palpitations accompanied by shortness of breath.  A note written on the morning following the ablation procedure states that there were no acute events overnight. The patient remained in normal sinus rhythm.  He denied chest pain, shortness of breath and palpitations. He is complained of gastroesophageal reflux disease (GERD) like symptoms. He also complained of a headache which was treated with Tylenol.  No abnormalities were noted on his physical examination. The patient was admitted to the Coronary/Cardiac Care Unit following the ablation procedure. There were no complications described during the procedure.  On day 2 of admission, the patient was judged to be stable and was discharged home, with arrangements made for outpatient follow-up in cardiology clinic.

A study by Marijon et al. (2009) looked at the safety and feasibility of same day discharge after Radiofrequency Catheter Ablation (RCA). The aim of this prospective, multicenter cohort study was to evaluate the feasibility and safety in 1,342 patients considered eligible for ambulatory RCA, according to specific set of criteria. The study concluded that same-day discharge after uncomplicated RCA for routine supraventricular arrhythmias is safe and may be applicable in clinical practice.

 A recent study by Bartoletti et al. (2019) investigated the safety and feasibility of early mobilization and same-day discharge following streamlined peri-ablation management for AF and it was concluded that selective same-day discharge after AF ablation is safe and feasible using a streamlined peri-procedural care protocol.

This patient was asymptomatic when he presented to the hospital, had normal vital signs, a normal physical exam and no evidence of heart failure or malignant arrhythmia.  There were no complications noted during or after the procedure. Based on his clinical examination and hospital course, in addition to a literature review, the full hospital admission was not necessary. The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The carrier's denial of coverage for the inpatient hospital admission is upheld. The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Idiopathic pulmonary fibrosis
Treatment: High Frequency Chest Wall Oscillation (HFCWO) machine (Smart Vest Airway Clearance System)
The insurer denied coverage for the High Frequency Chest Wall Oscillation (HFCWO) machine (Smart Vest Airway Clearance System). 
The denial is upheld. 

This is a male patient with a history of Idiopathic pulmonary fibrosis (IPF) who presented to his medical doctor (MD) with complaints of dyspnea and cough for about one year.  The patient complained of some yellow productive sputum.  Mycobacterium tuberculosis (MTB) was ruled out. The patient had previous diagnostic studies - Computerized tomography (CT) Chest and pulmonary function tests (PFT). The CT revealed Pulmonary Fibrosis Usual Interstitial Pneumonia (UIP) pattern. In addition, some traction bronchiectasis was also noted. PFT's revealed restrictive pattern with reduced DLCO (carbon monoxide diffusing capacity) which was consistent with diagnosis of IPF.  There was no evidence of any obstruction. The patient was prescribed proton pump inhibitor (PPI) for gastroesophageal reflux disease (GERD) symptoms. The patient was also recommended chest PT for mucus clearance. A Smart Vest was ordered for High Frequency Chest Wall Oscillation (HFCWO).

This patient's main clinical diagnosis was IPF. The patient did not have a diagnosis of Cystic Fibrosis, Chronic Obstructive Pulmonary Disease (COPD) Chronic Bronchitis, Bronchiectasis or Immotile Cilia Syndrome where high frequency chest wall oscillation (HFCWO) is indicated. The patient had some traction bronchiectasis described on CT findings secondary to IPF. Failure of chest physical therapy is not documented. There was no indication for HFCWO based on clinical information provided. The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The carrier's denial of coverage for HFCWO machine (Smart Vest Airway Clearance System) is upheld. The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic hypercapnic respiratory failure

Treatment: Medical Equipment (E0466RR x 3)

The insurer denied coverage for Medical Equipment (E0466RR x 3).

The denial is overturned. 

This is a female patient who has been previously diagnosed with chronic obstructive pulmonary disease (COPD) as well as chronic diastolic heart failure, hypertension, rheumatoid arthritis, depression, and tobacco use. The patient has been recommended to utilize noninvasive ventilation. Laboratory studies show that the patient had a partial pressure of carbon dioxide (PCO2) level of 59.1; and laboratory studies performed later that day revealed a PCO2 level of 79. A clinical note indicates that the patient had chronic hypercapnic respiratory failure secondary to late stage COPD. The patient's high carbon dioxide (CO2) levels have persisted with bi-level positive airway pressure (BiPAP) use and therefore, the patient's physician states that the patient requires home noninvasive ventilation.  

This patient has a significant past medical history and was previously in very critical condition; however, the patient remarkably improved with intravenous (IV) steroids as well as IV antibiotics and noninvasive ventilation. The patient was eventually weaned down to her baseline oxygen. The patient was also encephalopathic on presentation and eventually returned to baseline. Documentation indicates that the patient was hospitalized but was noted to be stable for discharge. The patient was recommended to utilize 2 liters of oxygen and noninvasive ventilation.
 
According to current literature, it is suggested that the use of nocturnal noninvasive ventilation (NIV) in addition to usual care for patients with chronic stable hypercapnic COPD is recommended with conditional recommendation, moderate certainty. As per the American Thoracic Society Guidelines, non-invasive mechanical ventilation is recommended for patients with chronic hypercapnic respiratory failure due to COPD.  This patient has chronic hypercapnic respiratory failure with PaCO2 level of 59 to 79. The patient also has diastolic heart failure and has failed therapy with BiPAP. Therefore, this noninvasive ventilation is considered medically necessary for this patient as per the American Thoracic Society Guidelines.

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for Medical Equipment (E0466RR x 3) should be overturned. The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dental Problems. 
Treatment: Dental/Orthodontic Procedure.  
The insurer denied comprehensive orthodontic treatment of adolescent dentition and periodic orthodontic treatment visit x 12. 
The health plan's determination is upheld in whole.

The patient is a male with mild maxillary and mandibular crowding. Tooth #6 is erupting lingually within the arch and baby teeth C and R remain. The patient has a Class I occlusion with overjet and 60% overbite. The patient is treatment planned for 24-30 months of orthodontics to align the teeth and correct the bite, but the plan was denied due to lack of medical necessity. The subject under review is the medical necessity of the requested treatment.

The health plan's determination is upheld in whole.

Tooth #6 is lingual, but it not impacted since it is visible in the maxillary photograph. There are no indications of gingival recession or pathology from the tooth position of #6. It is not as if the tooth were so crowded that it was prevented from erupting, which left untreated it could damage the roots of other permanent teeth leading to more invasive  procedures than orthodontic treatment.(1)
While the patient has crowded teeth, there is not anterior or posterior crossbite. There is no evidence of wear or periodontal recession. There are functional problems that may occur in the dentition that become more difficult, if not impossible, to correct if not addressed in adolescence. (2) This patient presents with none of those conditions. If his teeth were aligned, it would provide an esthetic improvement, but it would not create a medically significant improvement to the patient's health. For these reasons treatment is not medically necessary.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Helicobacter pylori infection
Treatment: Pylera 125-125 mg Capsule
The insurer denied the Pylera 125-125 mg Capsule.
The denial is upheld.

The patient is a male with Helicobacter (H) pylori. The attending physician (AP) is
requesting treatment with Pylera. 

No, the health plan should not cover the proposed treatment with Pylera. 

The patient has Helicobacter (H) pylori and needs treatment. There are multiple
generic medications used to treat Helicobacter pylori. Pylera is made up of
metronidazole, tetracycline and bismuth. There is no medical literature to support
that Pylera is more effective than the generic individual components of Pylera,
metronidazole, tetracycline and bismuth, for the treatment of Helicobacter pylori. In
addition, there is no medical literature to support that Pylera is more effective than
the formulary alternatives, such as metronidazole, tetracycline, clarithromycin,
amoxicillin, levofloxacin, and lansoprazole/amoxicillin/clarithromycin. Therefore, as
the patient has not tried and failed the formulary alternative components of Pylera,
the health plan should not cover the requested Pylera.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Low back pain. 
Treatment: Hysingla. 

The insurer denied coverage for Hysingla. 

The denial is upheld. 

This is a male patient with a history of low back pain. He has been taking oxycodone, but reports it only provides minimal relief. He has also undergone an epidural injection and physical therapy. The physician and patient do not want to trial the on-formulary opiate, Opana, and wish to utilize Hysingla extended-release (ER), an abuse deterrent form of hydrocodone. The patient has no documentation of opiate diversion, aberrant results on urine toxicology or violation of an opiate maintenance agreement. 

Opana has evidenced based support of efficacy and safety in patients with moderate to severe chronic low back pain. Martin et al. (2007) studied Opana: "Opioid-experienced (N = 250) patients with chronic, moderate to severe low back pain (LBP) were converted from their prestudy opioid(s) to an approximately equianalgesic dose of OPANA ER (oxymorphone extended-release). Patients continued slow titration, with 56% stabilized within 1 month to a dose of OPANA ER that reduced average pain to <40 mm on a visual analog scale with good tolerability." 

The utility of Hysingla in a patient with no history of drug abuse is questionable. As per Wen et al (2015), "The real-world impact of [hydrocodone (HYD)'s] abuse-deterrent technology is being assessed through epidemiologic studies." These studies have not been published to date. 

Thus, Hysingla is not considered medically necessary for this patient. An on-formulary trial of Opana is reasonable. 

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient. 

Based on the above, the medical necessity for Hysingla is not substantiated. The insurer's denial should be upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Adenocarcinoma of the prostate.
Treatment: Proton beam radiation therapy (procedure codes 77522, 77523, 77525 and 55874).
The insurer denied coverage for proton beam radiation therapy (procedure codes 77522, 77523, 77525 and 55874). The denial is upheld.

This is a male patient who presented with rising Prostate-Specific Antigen (PSA). The biopsy established diagnosis of Gleason 8 prostate cancer PSA was 9.56. Magnetic resonance imaging (MRI) of the patient's prostate showed localized disease. The patient was presented with all treatment options. He was treated with Proton beam radiation therapy.

There is emerging data suggesting that Proton is safe and effective for prostate cancer. However, there is lack of clinical outcome evidence (local control, disease free survival, and toxicity) of proton beam therapy relative to available standard therapies including surgery, brachytherapy, and photon beam therapy such as photon intensity-modulated radiation therapy (IMRT) for prostate cancer by well conducted randomized controlled trials or well conducted cohort trials from more than one institution. Without published clinical outcome evidence (local control, disease free survival, and toxicity) of proton beam therapy relative to available photon beam therapy such as IMRT, proton beam therapy for the treatment of this patient's prostate cancer is not the standard of care.      

Proton beam is Food and Drug Administration (FDA) approved. The patient is a candidate for radiation therapy. Proton beam is radiation treatment. Protons have been used to treat prostate cancer for last several years. There are several clinical publications for safety and efficacy of proton beam radiation therapy for prostate cancer. However, there is no randomized trial suggesting superior clinical outcome of proton beam for prostate cancer over commonly used IMRT. Most investigators recommend additional study for long term safety and efficacy of protons compared with photons before adopting protons as medically necessary treatment for prostate cancer.   

Mendenhall et al. (2014) reported 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. The authors concluded that 5-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Moreover, they stated that further follow-up and a larger patient experience are needed to confirm these favorable outcomes.                               
   
The proton beam radiation therapy is not likely to be more beneficial than any of the standard treatments/procedures for this patient. The standard therapies include surgery, brachytherapy, and photon beam therapy such as photon IMRT for prostate cancer. There is inadequate evidence from comparative studies to permit conclusions concerning the impact of proton beam therapy compared with other treatments for prostate cancer.

The denial of proton beam radiation therapy (procedure codes 77522, 77523, 77525 and 55874) is upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Spondylosis without Myelopathy or Radiculopathy, Lumbar Region. 
Treatment: Intracept Procedure-Intraosseous Ablation of the Basivertebral Nerve. 
The health plan denied the requested procedure. 
The health plan's determination is upheld. 

This is a male who has a one year history of low back pain. Pain level 9/10. Pain is exacerbated by prolonged standing and walking. This patient has tried pain medications, physical therapy (PT) and injections. From the review the medical records, none of these treatments rendered him any significant pain relief except some improvement from radiofrequency ablation (RFA) of bilateral (lumbar-sacral) L4 to S1, and the lumbar transforaminal epidural steroid injections. He reported 80% of pain relief after the lumbar RFA. However, he continued to have pain in his lower back and into his bilateral hips when standing more than 5 minutes. Physical examination was remarkable for decreased range of motion (ROM) in the back, mild pain with extension and facet loading, and antalgic gait. His past medical history documented lumbar radiculopathy, spinal stenosis with neurogenic claudication, sacroiliac joint dysfunction, vertebrogenic pain, lumbar spondylosis, and lumbar facet arthropathy. A magnetic resonance imaging (MRI) of lumbar spine revealed Grade 2 anterolisthesis with significant compression of bilateral L5 nerve roots. Modic type 1 end plate changes adjacent to the L5-S1 disc.
This patient was recommended to have this new medical intervention named INTRACEPT. The INTRACEPT system was designed to ablate intraosseous nerve within the vertebral body for the treatment of vertebrogenic low back pain. The issue is whether this patient is a candidate for this new INTRACEPT procedure. 

The health plan's determination regarding the proposed health service or treatment is upheld, in whole. 

The proposed intraosseous ablation of the basivertebral nerves is not likely to be beneficial for this patient's medical condition. 
The INTRACEPT system was designed to treat back pain from vertebral body by ablating intraosseous nerves. This is a relatively new and innovative approach that can potentially benefit this specific patient population with pain from vertebral body. However, the current clinical evidence indicated that this patient is not a candidate for this intervention. In one of the largest studies on the efficacy of INTRACEPT, the primary exclusion criteria included symptomatic spinal stenosis, disk protrusion>5 mm, spondylolisthesis>2 mm at any level, or radiculopathy. [1] Two other large studies adopted similar exclusion criteria [2-3]. This patient has diagnoses of lumbar radiculopathy and Grade 2 spondylolisthesis. An MRI revealed bilateral L5 nerve compression and spondylolisthesis much greater than 2mm. Therefore, this patient is not a candidate for this INTRACEPT procedure according to the current clinical evidence. The proposed intraosseous ablation of the basivertebral nerves is not likely to be beneficial for this patient's medical condition.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Neck pain and migraines.
Treatment:  Surgery - 64633-RT and 64634-RT (cooled radiofrequency neuroablation), Pre-service.

The insurer denied the Surgery - 64633-RT and 64634-RT (cooled radiofrequency neuroablation), Pre-service.  The denial is overturned. 

The patient is a female with neck pain and migraine headaches that has previously
had cooled radiofrequency ablation (c-RFA) with near 100% relief for almost one
year.

Yes, the proposed cooled radiofrequency neuroablation (64633-RT and 64634-RT) is medically necessary.

The requested cooled radiofrequency ablation (c-RFA) is medically necessary.  The procedure uses the same code as thermal radiofrequency ablation (t-RFA), often referred to as conventional radiofrequency ablation (RFA).  The temperature for cooled radiofrequency ablation (c-RFA) is above 60 degrees Celsius, which is often the temperature used in a thermal radiofrequency ablation (t-RFA).  Many of
the original articles on radiofrequency ablation (RFA) cite 60 degrees for ablation.  In addition, the tissue temperature has been shown to be 80 degrees.  Cooled radiofrequency ablation (c-RFA) is not to be confused with pulsed radiofrequency
ablation (RFA), where the temperature is below 42 degrees.  Neural ablation has
been shown to occur at 42 degrees Celsius.  Therefore, any temperature about 42 is
a thermal lesion.  Studies have shown conventional radiofrequency ablation (c-RFA) to be as effective as thermal radiofrequency ablation (t-RFA).

Studies have shown conventional radiofrequency ablation (c-RFA) to as effective as t-RFA.  It poses no increased risk and is an alternative to thermal radiofrequency ablation (t-RFA).  The distinction between the two is primarily due to proprietary technology.  No study has shown it to be inferior to  thermal radiofrequency ablation (t-RFA), and its
indications are same for thermal radiofrequency ablation (t-RFA).  In essence, there is no distinction, and it can be used in all settings that  thermal radiofrequency ablation (t-RFA) can be used. 

This patient has chronic low back pain with facet arthropathy.  The patient has had
two diagnostic medial branch blocks and previously had radiofrequency ablation (RFA) with excellent results.  Therefore, the criteria according to the Spine Intervention Society has been met, and this is medically necessary and standard of care.  In essence, there is no distinction, and it can be used in all settings that  thermal radiofrequency ablation (t-RFA) can be used.  In addition, the patient has previously undergone this procedure with near 100% relief for about a year.  Given the above, the requested conventional radiofrequency ablation (c-RFA) is medically necessary.