Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned

This is a woman with decades-long history of gastroesophageal reflux disease (GERD), who presents for evaluation for LINX.  She has cough and hoarseness despite pantoprazole and Zantac. An esophagogastroduodenoscopy (EGD) showed a small hiatal hernia. An upper gastrointestinal (UGI) test was normal.  Manometry was normal.  The DeMeester score was 33.  

The patient is a good candidate for LINX. Upon review of the peer reviewed medical literature, LINX is safe and effective for patients with small hiatal hernias, no Barrett's esophagus, and no left anterior (LA) grade C or D esophagitis. LINX is FDA approved. Results of current medical literature shows that LINX is an acceptable alternative to Nissen Fundoplication and may have less side effects. 

The LINX is considered an acceptable alternative to the gold standard, Nissen Fundoplication. While the LINX may have a better side effect profile than Nissen fundoplication, there are no head to head trials that show that LINX is better than the Nissen fundoplication. Therefore, given that Nissen Fundoplication is considered the standard, LINX would not be considered the best available treatment and would not likely be more beneficial than any standard treatments/procedures.
  
The carrier's denial of coverage for procedure code 43284 Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (i.e., magnetic band), including cruroplasty when performed should be upheld.
Appeal type: Experimental/Investigational
Decision: Overturned

The patient has chronic gastroesophageal reflux. Ambulatory pH monitoring revealed an elevated DeMeester score. She has been on treatment with Zantac and Pantoprazole. Her doctor has advised having the LINX procedure.

In March 2017, The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conducted an updated Safety and Effectiveness Analysis of the LINX Reflux Management System. The conclusion was that long-term follow-up supports the FDA conclusion that the device is safe. The LINX implant results in 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 data demonstrates that the LINX reflux management system is effective in the management of GERD.

The patient has an elevated DeMeester score and is a good candidate for the procedure. LINX has been shown to be an effective treatment, it is minimally invasive, and is appropriate for patients who have continued symptoms of GERD on medical management and do not wish to have more extensive surgery. Additionally, the LINX is likely to be more beneficial than any standard treatments or procedures for this patient.

The carrier's denial of coverage for procedure code 43284 Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (i.e., magnetic band), including cruroplasty when performed should be reversed.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease (GERD)

Treatment: LINX procedure

The insurer denied coverage for the LINX procedure. The denial was reversed.
This is a female with a history of gastroesophageal reflux disease (GERD) for 30 years. The plan was for a LINX procedure. An esophagogastroduodenoscopy (EGD) was performed and a Bravo capsule was placed. Biopsies revealed chronic gastritis, mild esophagitis and no goblet cell metaplasia. A pH monitoring revealed a DeMeester score of 33, consistent with abnormal acid exposure and a positive correlation between symptoms and reflux. UGI studies revealed a very small hiatal hernia, and a double contrast UGI showed no GERD reflux.  High resolution esophageal motility revealed normal peristalsis and pressures with a 50% incomplete bolus clearance.

The LINX is indicated for patients diagnosed with GERD as defined by abnormal pH testing and who are seeking an alternative in the management of their GERD. There is scientific evidence in peer reviewed literature to support and substantiate the LINX's improvement in health outcomes, as well as its safety and effectiveness. It is approved by the FDA. Given the patient's history of GERD and DeMeester score of 33, the LINX would be considered as good a treatment modality as the gold standard, which is fundoplication, but with less significant side effects and morbidities. The LINX is a less invasive way to treat this patient's problem. Therefore, this treatment would likely be more beneficial for this patient than the standard treatment as it is less invasive and does lead to good clinical outcomes.
The carrier's denial of coverage for procedure code 43284 Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (i.e., magnetic band), including cruroplasty when performed should be reversed.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Persistent and progressive periapical pathology of tooth #12
 
Treatment:  Apicoectomy and retrograde filling procedures

The insurer denied the apicoectomy and retrograde filling procedures.  The denial was reversed.

This patient had persistent pain in tooth #12 and ultimately had root canal therapy performed.  Despite this treatment, the patient remained with persistent discomfort and pain on palpation of the area.  In addition, there was mucosal erythema, a periapical lesion and evidence of acute infection.  Due to this pathology, apicoectomy and retrograde filling procedures were recommended.  The insurer has denied these services, stating that there will be 8 points of contact, and, therefore, the request is denied. 

It appears that despite appropriate and adequate endodontic therapy on tooth #12 there remained persistent and progressive periapical pathology that needed to be addressed.  The recommended services are standard of care in dental practice, with or without sedation, as needed for patient compliance.  As the recommended treatments are standards of care in dental practice, and the clinical circumstance is amenable to these services, they are deemed medically necessary.

The carrier's denial of coverage for Intravenous Moderate, Apicoectomy and retrograde filling of tooth # 12 is reversed.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Polyarthritis, abnormal gait, osteoporosis
Treatment: Increase in PCW services from 5 hours per day to 6 hours per day

The proposed treatment, Increase in PCW services from five hours per day to six hours per day, is not medically necessary as demonstrated by the available medical records and documents.

Uniform assessment system of New York completed on two different dates along with the clinical information provided document that the current level of care is sufficient to meet the patient's needs.  No significant changes in the patient's condition are identified when comparing the assessment with the previous assessment. The patient, family member and treating physician have not provided any additional medical needs that would require the requested change in PCW hours.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Lumbar Radiculopathy
Treatment:  Inpatient Hospital and Two Level Lumbar Artificial Disc Replacement Surgery
The insurer denied the Inpatient Hospital and Two Level Lumbar Artificial Disc Replacement Surgery.  The denial was upheld. 

This is a male patient with a history of lumbar radiculopathy.  It is reported that the patient underwent a two level artificial disc replacement after multiple surgeries at both levels after failing conservative treatments.  It was felt that he was better suited to undergo disc replacement surgery versus a stabilizing fusion for better range of motion. 

Radcliff, et al. states, "Study Design: Long-term analysis of prospective randomized clinical trial data.  Summary of Background Data: Lumbar total disk replacement (TDR) has been found to have equivalent or superior clinical outcomes compared with fusion and decreased radiographic incidence of adjacent level degeneration in single-level cases.  Objective: The purpose of this particular analysis was to determine the incidence and risk factors for secondary surgery in patients treated with TDR or circumferential fusion at 2 contiguous levels of the lumbar spine.  Methods: A total of 229 patients were treated and randomized to receive either TDR or circumferential fusion to treat degenerative disk disease at 2 contiguous levels between L3 and S1 (TDR, n=161; fusion, n=68). Results: Overall, at final 5-year follow-up, 9.6% of subjects underwent a secondary surgery in this study.  The overall rate of adjacent segment disease was 3.5% (8/229).  At 5 years, the percentage of subjects undergoing secondary surgeries was significantly lower in the TDR group versus fusion (5.6% vs. 19.1%, P=0.0027).  Most secondary surgeries (65%, 17/26) occurred at the index levels.  Index level secondary surgeries were most common in the fusion cohort (16.2%, 11/68 subjects) versus TDR (3.1%, 5/161 subjects, P=0.0009).  There no statistically significant difference in the adjacent level reoperation rate between TDR (2.5%, 4/161) and fusion (5.9%, 4/68).  The most common reason for index levels reoperation was instrumentation removal (n=9).  Excluding the instrumentation removals, there was not a significant difference between the treatments in index level reoperations or in reoperations overall.  Conclusions:  There were significantly fewer reoperations in TDR patients compared with fusion patients.  However, most of the secondary surgeries were instrumentation removal in the fusion cohort.  Discounting the instrumentation removals, there was no significant difference in reoperations between TDR and fusion.  These results are indicative that lumbar TDR is non inferior to fusion."(1)

Based on the above, the medical necessity for the inpatient hospital services from is not substantiated.  The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Handicapping malocclusion

Treatment: (D8080) braces

The insurer has denied coverage for (D8080) braces. The denial was reversed.

The patient is a female child. Upon review of the submitted documentation including lateral cephalometric radiograph, panoramic radiograph, montage of extraoral and intraoral clinical images, treatment records, copies of abstracts of peer reviewed literature as well as insurer correspondence, it appears that this patient presented for evaluation for orthodontic care. The orthodontist recommended comprehensive orthodontics due to skeletal Class I malocclusion, crowding and deep impinging overbite. The orthodontist has completed the Handicapping Labiolingual Deviation (HLD) Index as required and has chosen the automatically qualifying condition of deep impinging overbite with severe soft tissue damage to support orthodontic necessity. 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 21 points on review by internal reviewers. 

Upon review of the submitted documentation, (study models were not provided for review), 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, a 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 deep impinging overbite with severe soft tissue damage. This reviewer finds that this automatically qualifying condition criterion is met and does support comprehensive 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.  This is confirmed by several studies. 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.  

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

Based on the above, the medical necessity for (D8080) braces is substantiated.  The insurer's denial is reversed.
Appeal type: Medical necessity
Decision: Upheld

The patient is a female with  a skeletal class II molar malocclusion. She has a severe overjet and moderate overbite. She has mild maxillary and mandibular crowding. The proposed treatment is braces for 24-30 months.
The subject to be determined is the medical necessity for braces.

Using the Handicapping Labio-Lingual Deviation (HLD) index, the malocclusion would score a 10 with no auto qualifier present. Auto qualifiers include deep impinging overbite, anterior crossbite causing clinical attachment loss and recession of the gingival margin, overjet 9 millimeter (mm) or greater and underbite 3.5mm or greater. Since the HLD score is less than 26 without an auto qualifier, braces are not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

This is a patient who suffered an accident and tooth number (#) 8 was severely intruded. The oral surgeon referred the patient to an orthodontist to have the tooth moved back to proper position. The tooth became ankylosed and needed to be surgically luxated. Now the tooth is moving orthodontically. The issue under review is the medical necessity of braces.
The health plan's determination of medical necessity is overturned.
The American Association of Endodontists (AAE) produces the definitive guide to managing dental emergencies. In this guideline, it discusses proper treatment of teeth with intrusive luxations, which this patient has. The document describes how teeth intruded greater than (>) 7 millimeters (mm) with incomplete root formation should be repositioned orthodontically.  As shown in the document from the AAE, orthodontic treatment is necessary to return function to the intruded tooth. Orthodontic treatment is therefore medically necessary.
Appeal type: Medical necessity
Decision: Upheld

This is a patient who presented with abdominal pain associated with nausea/vomiting.He had a recent admission for abdominal pain with a thorough workup and multiple imaging studies, with no clear etiology. Gastroenterology (GI) was consulted. General surgery was consulted and no surgical intervention was needed. The patient was given intravenous (IV) fluids. He was given pain medication and Zofran. He underwent an EGD. He was placed on a proton pump inhibitor (PPI) twice a day. The health plan's determination is upheld. He presented with abdominal pain, nausea, and vomiting, but did not have hemodynamic instability, evidence of severe dehydration (with acute renal failure or severe electrolyte abnormality). He did not have signs or symptoms suggesting acute surgical management would be needed. "Symptoms in patients with abdominal pain that are suggestive of surgical or emergent conditions include fever, protracted vomiting, syncope or presyncope, and evidence of gastrointestinal blood loss."
The patient did not have peritonitis, or evidence of volume depletion.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: COPD
Treatment: Inpatient admission
The inpatient admission was not medically necessary.
The patient's respiratory distress as, well as tachycardia and tachypnea improved with emergency room care. At the time of admission, the patient was hemodynamically stable with improved wheezing.  The patient was able to take oral medications.  Thus, the acute in hospital level of care is not medically necessary, as the patient's condition improved with emergency room care. Treatment at the observation level of care would have been appropriate.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest pain
 
Treatment: Inpatient admission, monitoring, diagnostic testing

The insurer denied the inpatient admission. The denial was upheld. 

The patient was a woman with a past medical history notable for asthma, diabetes mellitus, hypertension, and hyperlipidemia. The patient presented to the Emergency Room (ER) with complaints of chest pain and shortness of breath. The electrocardiogram (EKG) showed non-specific T changes. The vital signs were unremarkable. The physical examination was non-diagnostic. The Troponin levels were negative. The patient was admitted and ruled out for myocardial infarction. Nuclear stress testing was done and was negative. The patient was clinically and hemodynamically stable and was deemed appropriate for discharge for an outpatient echocardiogram to be scheduled. 

The patient presented with chest pain, however the initial evaluation in the Emergency Room was unremarkable, including negative cardiac troponin levels, and a non-diagnostic electrocardiogram (EKG). The Inpatient admission was not medically necessary for this patient. In the absence of elevated cardiac biomarkers and a diagnostic electrocardiogram, the patient's care could have been provided in the observational setting, allowing for additional cardiac testing.

Further evaluation was warranted, however inpatient admission criteria were not met. Although the patient had new onset symptoms, medical criteria were not met for any other additional extenuating circumstances. There were no other high-risk co-morbidities. 

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

The patient is a female with a locally advanced left breast carcinoma.  She received neoadjuvant chemotherapy followed by breast conservation surgery.  She is at risk of recurrence and radiation therapy is recommended to decrease this risk of recurrence.  Proton beam approach of radiation is recommended.

The health plan's determination is upheld.

The proposed proton beam radiation therapy is not considered a standard of care treatment option for this patient with her clinical situation of a left breast carcinoma post chemotherapy and conservation surgery.  There is a lack of significant medical literature published in peer reviewed journals supporting the benefit of proton beam radiation therapy over conventional photon three dimensional (3D) or intensity modulated radiation therapy (IMRT) radiation therapy for breast carcinomas.  Additional clinical trials published in peer reviewed journals are needed to determine the efficacy and safety of proton beam radiation therapy for this clinical situation.  The proposed proton beam radiation therapy is also not supported by National Comprehensive Cancer Network (NCCN) guidelines.  The recommended proton beam radiation therapy for this patient and her clinical scenario is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Stage IV Non-Small Cell Lung Cancer with Brain Metastasis 
Treatment: Proton Beam Therapy

The insurer denied the Proton Beam Therapy. The denial was upheld.   

This case involves a middle aged male patient with a history of epidermal growth factor receptor mutant stage IV non-small cell lung cancer with brain metastasis, osseous metastasis, status post afatinib, palliative radiotherapy and kyphoplasty with intraoperative radiotherapy to spinal metastasis, and intrathecal methotrexate.  The patient was on Tagrisso 80 mg daily.  He presented to clinic in early 2019 for consideration of palliative radiation therapy, particularly for treatment of his spinal disease. The recommendation was for proton beam therapy for palliation specifically for spinal disease. There was also documentation that the patient was in a clinical study for his diagnosis. 

 As per National Comprehensive Cancer Network (NCCN), when considering palliative radiation therapy (RT) for advanced metastatic disease shorter courses are preferred albeit with a higher need for retreatment. They do not give preference to proton therapy (PT). They state that when higher doses (30Gy) are warranted, "technologies to reduce normal tissue irradiation (at least 3D-RCT and including intensity modulated radiation therapy [IMRT] or proton therapy as appropriate) may be used."  As medical literature does not support the use of proton beam therapy as opposed to other forms of more advanced RT for lung cancer patients.

The carrier's denial of coverage for Proton Beam Therapy for dates of service is upheld.  The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Breast Cancer with metastasis right axillary lymph nodes

Treatment: Proton Beam Therapy

The insurer has denied Proton Beam Therapy.    The denial was upheld.

This patient is a female with a past history to include diabetes, as well as hypothyroidism, fibrocystic breast tissue and Hashimoto's disease.  The patient did undergo a bilateral mammogram with evidence of an 8.8 cm mass and abnormal appearing axillary lymph nodes.  The patient did undergo a biopsy showing invasive ductal carcinoma poorly differentiated, ER/PR negative, and HER-2/NEU positive findings.  The right axillary lymph nodes were also positive for metastatic adenocarcinoma.  The patient was started on neoadjuvant chemotherapy and underwent a mastectomy.  She was noted to have residual invasive carcinoma and the patient was in need of postmastectomy radiation therapy.  She enrolled in a trial randomizing to photon based versus proton.  The documentation indicated the patient did participate in the study and underwent proton beam therapy.

The National Comprehensive Cancer Network (NCCN) indicates that the best management for any patient with cancer is in a clinical trial and patient participation in clinical trials is encouraged. The NCCN indicates that the standard of care is intensity-modulated radiation therapy. The American Society for Radiation Oncology (ASTRO) indicate that proton beam therapy is not new or experimental and support its use for patients with breast cancer who are currently enrolled in a Western Institutional Review Board (WIRB) approved clinical trial.  However, while the treatment is supported in clinical trials per the NCCN and ASTRO for patients such as this one, the treatment is not considered the standard of care. Furthermore, the medical literature indicates that while early clinical results with proton therapy for breast cancer are encouraging, further studies are necessary.  There is no Dose-volume histogram present as well for the total lung. 

As this is not the standard of care and since further studies are needed to establish safety and efficacy, the treatment is not medically necessary.  The insurer acted reasonably, with sound medical judgement, and in the patient's best interest.

Based on the above, the medical necessity for Proton Beam Therapy for service is not substantiated.  The insurer's denial is upheld.