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

Diagnosis: Hypertension, memory loss, low back pain, right
shoulder pain, right wrist carpal tunnel syndrome
and generalized anxiety disorder
Treatment: Increase Personal Care Assistance, 5 Hours per Day, 5 Days per Week, for a Total of 25 Hours per Week
The insurer denied the Increase Personal Care Assistance, 5 Hours per Day, 5 Days per Week, for a Total of 25 Hours per Week
The denial is overturned. 

The patient is a female with a history of hypertension, memory loss, low back pain, right shoulder pain, right wrist carpal tunnel syndrome and generalized anxiety disorder. Due to impairments related to these conditions, she requires assistance for completion of many of her activities of daily living (ADLs). 

Appeal review requested for potential approval of an increase in personal care assistance, five hours per day, five days per week, for a total of 25 hours per week to offer increased activities of daily living (ADLs) support.

Yes, the proposed treatment of 25 hours per week personal assistance services is deemed medically necessary.
This is a female with a history of hypertension, memory loss, low back pain, right shoulder pain, right wrist carpal tunnel syndrome and generalized anxiety disorder. Although an assessment of the patient's functionality and ability to perform activities of daily living (ADLs) was completed and revealed that the currently approved plan of 20 hours per week Personal Assistance Services is sufficient to meet the patient's current needs, the beneficiary's medical provider relates this reduced schedule leaves the patient home alone, completely unassisted for numerous hours per day. This is problematic as she needs frequent assistance and supervision due to imbalance and unsteady gait. Furthermore, medical appointments are frequent as she is receiving treatment for teeth, vision and her right knee. With limited service hours, medical appointments have to be rescheduled and many times postponed for extended durations which is unsafe given the patient's multiple medical conditions. 

Hence, provision of 25 hours per week personal assistance services can reasonably be expected to be beneficial for the patient and withholding these services, in whole or in part, can reasonably be expected to affect the patient's health adversely. For these reasons, the proposed treatment of 25 hours per week personal assistance services is deemed medically necessary.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Symptomatic Vascular Malformation

Treatment Sirolimus powder compound

The insurer denied coverage for Sirolimus powder compound

The denial is overturned

The patient is a young child with a diagnosis of a symptomatic vascular malformation.  The requested medication is topical sirolimus.  

The patient suffers from a rare medical anomaly which has limited treatment options.  Although, the insurance has suggested topical tacrolimus, there is significant difference in the possible improvement one would reasonably expect from sirolimus compared to tacrolimus.  A search using Pubmed with the terms "symptomatic vascular anomalies" or "vascular anomalies" with "sirolimus" revealed multiple peer reviewed articles supporting its efficacy. In contrast, when pimecrolimus and tacrolimus was substituted for sirolimus, there were essentially no peer reviewed articles found. 

Given the limited treatment options, especially in a young child, as well as the symptomatic nature of the vascular malformation the requested medication, topical sirolimus is overturned.

The requested drug is likely to produce a more clinically beneficial outcome to the patient. 

Based on the above, denial of Formulary Exception for Sirolimus powder compound is overturned.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Microscopic Colitis
Treatment: Entyvio (vedolizumab)

The insurer denied coverage for Entyvio (vedolizumab).
The denial is upheld.

The patient has a history of lymphocytic colitis. She has been treated with budesonide. The physician cites a reference from a Swedish study of rheumatoid arthritis patients that anti -TNF (tumor necrosis factors) agents increase the risk of melanoma. There is also another study that is referenced that showed that vedolizumab was more effective if used prior to giving anti TNF agents.

Up To Date has an article titled "Microscopic colitis: Clinical manifestations, diagnosis and management." The article states that in patients with refractory microscopic colitis anti-TNF agents or immunomodulators can be used, although there is only limited evidence from a small series of patients. Vedolizumab could be considered in selected patients with severe symptoms refractory to Budesonide. There is a reference to an article "Vedolizumab in Refractory Microscopic Colitis" (Journal of Crohn's Colitis 2019;13(3):337). The conclusion was that vedolizumab induced remission in 5/11 patients, but that larger randomized trials were needed to assess the efficacy of Vedolizumab in patients with microscopic colitis.

An article titled "American Gastroenterological Association Institute Guideline on the Medical Management of Microscopic Colitis" reviews various advised treatments including budesonide, mesalamine, bismuth, prednisone, and cholestyramine. There is no recommendation to give vedolizumab.

This patient has microscopic colitis. There are a few reports of a limited number of patients who have received vedolizumab for this condition. However, there is no large controlled study that has advised that vedolizumab should be used for lymphocytic colitis. Using vedolizumab for microscopic colitis is not supported by the literature. The health care plan acted reasonably and with sound medical judgment. Entyvio is not medically necessary for this patient. 

Based on the above, the medical necessity for the Entyvio (vedolizumab), procedure code J3380 is not substantiated. The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Back Pain. 
Treatment: Pain Management (transforaminal epidural steroid injection). 

The insurer denied the Pain Management (transforaminal epidural steroid injection). 
The denial is overturned. 

The patient is a female with low back pain radiating to the right lower extremity. The pain is a 7/10. Pain medications include mobic, cylobenzabprine, tylenol and diclofenac gel. Physical examination is significant for positive right straight leg raise and paravertebral tenderness. MRI (magnetic resonance imaging) of the lumbar spine shows mild degenerative disc and facet changes as well as disc bulges throughout with some progression vs previous MRI (magnetic resonance imaging). The patient had interventions for the lumbar spine including lumbar medical branch blocks, RFA (radiofrequency ablation), and caudal ESI (epidural steroidinjection). The patient previously tried and stopped due to side effects: gabapentin, lyrica, and cymbalta. The provider ordered a left L4 (fourth lumbar spine vertebra) and L5 (fifth lumbar spine vertebra) transforaminal epidural steroid injection. The provider wrote an appeal letter noting patient has tried treatments "such as physical therapy massage, therapy and chiropractor treatment for greater than 3 months with minimal relief." 

Yes, the requested transforaminal epidural steroid injection is medically necessary. 
The patient has lumbar radicular pain, VAS (Visual Analogue Scale) 7/10, advanced MRI (magnetic resonance imaging), and has failed more than 3 months of active conservative treatment per report.  The patient has not tried this injection previously. Considering above clinical notes, current appeal letter, and evidence for the procedure, transforaminal epidural steroid injection is indicated and medically necessary for this patient at this time. 

No, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient. 
Based on the initial clinical information, the health plan did not act reasonably and with sound medical judgement. Given the information provided in the appeal letter regarding lack of benefit of conservative treatment, including more than 3 months of physical therapy for the patient's condition, the procedure is medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dental Problems. 
Treatment: Dental/Orthodontic Procedure. 
The insurer denied Braces and monthly visits. 
The denial is upheld. 

The patient is a female with Skeletal Class III malocclusion, mild mandibular crowding, and mild maxillary crowding, with a mild overjet and mild overbite. The patient has been recommended for braces and monthly visits (times [x]12).
At issue is the medical necessity of Braces and monthly visits (x12).

The health plan's determination is upheld in whole.

The requested health service/treatment of Braces and monthly visits (x12) is not medically necessary for this patient.
Using the Handicapping Labio-Lingual Deviation (HLD) index, the malocclusion would score a 19 with no auto qualifiers. Auto qualifiers include cleft palate deformity or cranio-facial anomaly, impacted permanent anteriors where extraction is not indicated, anterior crossbite causing clinical attachment loss and recession of the gingival margin, severe traumatic deviations, overjet 9-millimeter (mm) or greater and underbite 3.5 mm or greater. This case requires a score of 26 or more for treatment to be considered medically necessary. The malocclusion in question does not meet the criteria to be classified as handicapping and treatment would not be considered medically necessary.
Thus, according to the generally accepted standard of care, braces, and monthly visits (x12) are not medically necessary for this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Oligodontia. 
Treatment: D6010 implant placement for tooth 6, 8, and 9. 

The insurer denied coverage for D6010 implant placement for tooth 6, 8, and 9. 

The denial is upheld. 

Based on review of the submitted documentation which includes copy of panoramic radiograph, dental treatment note, in addition to insurer correspondence, it appears that this patient presented for dental evaluation and treatment and discussion regarding prosthetic rehabilitation for the maxilla. The dentist has recommended endosteal implants in areas as enumerated above. The dentist is requesting implants over removable partial dentures presumably due to patients reported dysphagia, difficulty with mastication and nausea. The insurer has denied the aforementioned services stating that in their estimation endosteal implants are not the only appropriate treatment, and implant services are only covered when there is a documented medical condition that will be alleviated by the implants.  

Upon review of the objective documentation which primarily consists of the panoramic radiograph, the patient exhibits oligodontia in the maxilla and mandible. As regards to endosteal implant placement, although implants are an acceptable treatment to restore edentulous spaces, an accepted standard of care in dentistry is not exclusively endosteal implants. Alternative appropriate treatment would include conventional removable dentures. 

In this case, the removable partial denture in the maxilla would be entirely tooth borne, the most stable and retentive of all removable appliances. Further the documentation provided does not support, justify, or substantiate the requested treatment. Therefore, as removable partial dentures remain a standard of care in general dental practice, and the medical documentation does not indicate a specific limitation precluding use of dentures aside from self-reported difficulty, the endosteal implants are considered elective and not medically necessary. 

An appropriate alternative standard of care treatment would be conventional removable denture and the medical documentation provided does not substantiate a limitation that would preclude the patient using a removable partial denture. Therefore, as other acceptable alternative treatments are appropriate, and the documentation provided does not support the recommended treatment, this renders the endosteal implants and associated services not medically necessary. 

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

The insurer's denial of coverage for D6010 implant placement for tooth 6, 8, and 9 is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 

The insurer denied Stelara 90 milligrams (mg) every 4 weeks. 
The denial is overturned.

The patient is a female with a history of Crohn's disease (CD). She previously tried and failed mesalamine and corticosteroids. She was then started on Stelara standard dose (90 milligrams [mg] every 8 weeks). However, she continued to have active disease and was escalated to 90 mg every 4 weeks. She responded well to the higher dose.
The requested service is the medical necessity of Stelara at 90 mg every 4 weeks.

The health plan's determination is overturned.

Stelara is approved by the Food and Drug Administration for treating Crohn's disease in adults. The approved dose is 90 mg every 8 weeks. However, dose escalation is often required in order to achieve therapeutic levels. There are many peer-reviewed literature reports showing that low Stelara levels were associated with poor clinical response. The requested dose of 90 mg every 4 weeks is proven to be effective in patients who fail the standard dose.
Per Ollech, Jacob E., et al: "Shortening the ustekinumab 90 mg dose interval to 4 weeks for patients with CD who did not respond to doses every 8 weeks improved clinical and biological indices of disease activity. Patients who lose response to the standard dose of ustekinumab might benefit from dose interval shortening, which was effective and safe."
Per Cohen, Erica et al: "A majority of patients with moderate to severe CD benefited from ustekinumab (UST) dose escalation suggesting the clinical utility of optimizing dosing in the treatment course. "
This patient has a history of refractory Crohn's disease which failed conventional therapy and Stelara at the standard dose (90 mg every 8 weeks). She responded well to the requested dose. Therefore, continuation of Stelara at the requested dosing regimen is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Malocclusion.

Treatment: Braces and monthly visits.

The insurer denied coverage for braces and monthly visits.

The denial is upheld.

Upon review of the submitted documentation including lateral cephalometry radiograph, panoramic radiograph, montage of extraoral and intraoral clinical images, orthodontist treatment records, copies of peer reviewed literature as well as insurer correspondence, it appears that this patient presented for evaluation for orthodontic care. The orthodontist identified several clinical findings including overbite, open bite, Class I malocclusion, Class II canines, anterior crowding and has recommended orthodontics. The orthodontist has completed the Handicapping Labio-Lingual Deviation (HLD) index attaining 13 total points to support orthodontic care. 

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

In this case, the treating orthodontist does not claim an automatic qualifying condition
and completes the second portion of the index arriving at 13 points to justify orthodontic care. This reviewer concurs with the index completed by the orthodontist attaining a total of 13 points on the HLD index (4 overjet, 8 open bite, 1 labiolingual spread) which is below the threshold of 26 points to support orthodontic care. Of note is in this case, the patient's own orthodontist does not attain 26 points on the HLD index as required for orthodontic approval and is aware of this limitation.
 
Regarding the validity of the Handicapping Labiolingual 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 referenced below.

Each of the peer reviewed articles concludes that the index is a valid and reliable determinant 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 not substantiate the medical/dental necessity of orthodontic care as it does not meet the accepted criteria for approval.
The healthcare plan acted reasonably and with sound medical judgment and in the best interest of the patient.

Braces and monthly visits are not considered medically necessary for this patient.

The insurer's denial of coverage for the braces with monthly visits is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Myasthenia Gravis

Treatment: Gamunex-C

The insurer denied coverage for Gamunex-C.

The denial is overturned. 

This female patient has a history of myasthenia gravis (MG).

Regarding therapy during pregnancy, Up to Date states "Prednisone is the immunosuppressant of choice in pregnancy [4]. In addition to glucocorticoids, azathioprine and cyclosporine may be used if anticholinesterases fail to control MG exacerbations [4]. These medications have been well studied in pregnancy, mainly in transplant recipients and patients with autoimmune diseases other than MG, and have been found to be relatively safe [21, 22]. However, high doses of cyclosporine and azathioprine have been linked to spontaneous abortion, preterm labor, low birth weight, chromosomal damage [2, 21, 22], and hematologic suppression; they should be reserved for pregnant women who are not controlled, cannot tolerate glucocorticoids, or have significant comorbidities that may worsen with glucocorticoid administration [2, 21-23]. The risk of continuing these medications in high doses should be weighed against the benefit of controlling myasthenic symptoms. Mycophenolate mofetil and methotrexate increase the risk of teratogenicity and should not be used in pregnancy [4]."

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

The carrier's denial of coverage for Gamunex-C is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: heart disease
Treatment: Inpatient stay
The insurer denied the inpatient stay. 
The health plan's determination is upheld. 

This is a woman who presented to the hospital for a scheduled electrophysiologic study and catheter ablation of frequent symptomatic premature ventricular complexes (PVCs). Her medical history was remarkable for hypertension and hyperlipidemia. Her left ventricular systolic function was normal. Electrophysiologic testing and mapping revealed PVCs originating in the right coronary cusp. Radiofrequency ablation in this area as well as the adjacent right ventricular outflow tract abolished the ectopy. The procedure was uncomplicated. The patient was admitted to the hospital for monitoring overnight. Coverage for an inpatient admission is at issue.

The inpatient admission was not medically necessary. 
This woman presented for elective catheter ablation of frequent idiopathic ventricular ectopy that was mapped to the right coronary cusp. The arrhythmogenic focus was successfully ablated and the procedure was uncomplicated. Same-day discharge after elective uncomplicated catheter ablation has been shown to be safe and effective in the majority of patients who do not have significant structural heart disease. Theodoreson et al published a retrospective review of 897 patients who underwent radiofrequency catheter ablation of supraventricular arrhythmias and idiopathic ventricular arrhythmias, 805 of whom were discharged home the same day. Among all patients with a same-day discharge, none had a subsequent complication that would have been detected had they remained in the hospital overnight. In this particular case, given the proximity of the ablation site to the right coronary artery, overnight monitoring post-procedure was reasonable. However, it did not require an inpatient level of care. A lower level of care would have been appropriate.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: abdominal pain.
Treatment: Inpatient admission.
The insurer denied the inpatient admission. 
The health plan's determination is overturned in part. 

The patient is a female with past medical history (PMH) of GAD (generalized anxiety disorder), asthma, diabetes mellitus type 2 (DM2), gastroesophageal reflux disease (GERD), HLPD (hyperlipidemia), hypertension (HTN), and post-traumatic stress disorder (PTSD) who was admitted with complaints of abdominal pain associated with nausea, distention, and constipation. Vital signs were notable for HTN. Physical exam was notable for no apparent distress (NAD), abdomen soft with mild diffuse tenderness without guarding or rebound. Lab work was unremarkable on admission. A computed tomography (CT) scan showed no acute pathology. The patient was diagnosed with abdominal pain and treated with proton pump inhibitor (PPI).

The initial dates of service were appropriate for the lower level of care. However, an inpatient admission was medically necessary for the final 3 days of the admission. The patient was initially admitted, but subsequently her lab work demonstrated significant acute kidney injury with an increase of creatinine from 0.6 to 3.2, which demonstrated a substantial decrease in glomerular filtration rate (GFR), above a 70% reduction. The patient required close monitoring for adverse sequela such as electrolyte abnormalities and telemetry for arrhythmia monitoring. Given the severity of the acute kidney injury (AKI), this patient was a poor candidate for observation dehydration care. In addition, given this patient's abdominal complaints, she was a poor candidate for oral hydration therapy, another indication that an inpatient level of care was required for safe treatment. The patient did not develop the severe AKI until day 5, when the inpatient level of care was medically necessary.