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

Diagnosis: Dental Problem. 
Treatment: Dental/Orthodontic Procedure. 
The insurer denied braces. 
The denial is overturned.

The patient is a male with a Class I occlusion with 2 millimeter (mm) overjet. He has a 100% overbite with wear on the lower incisors, and the cephalometric radiograph indicates he is biting on his palate. He has moderate maxillary and mandibular crowing. He is treatment planned for orthodontics to correct his malocclusion which was denied by the plan on the basis that treatment is not medically necessary.

The health plan's determination is overturned.

The patient has maxillary and mandibular crowding. His overbite is deep and there appears to be wear developing on the lower incisors. His cephalometric radiograph shows the lower incisors are contacting the palate in occlusion. There is scientific evidence correlating deep anterior overbite with gingival contact and periodontal disease.1
The patient's occlusion is causing his lower incisors to contact right at the lingual gingival margin of the maxillary incisors. This is a traumatic occlusion. Not only does it have a positive correlation with periodontal disease, but studies also indicate an increased appearance of periodontal radiolucencies on the maxillary incisors.1 It is believed these periodontal lesions are related to gingival surface injury and food impaction due to the deep bite.2 Therefore, correcting the patient's malocclusion with orthodontic treatment will create a clinically significant improvement in the patient's periodontal health. Orthodontic treatment (braces) is deemed medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Mental Health/Depression
Treatment: Mental Health Outpatient
The health plan denied the requested transcranial magnetic stimulation (TMS) as not medically necessary. 
The health plan's determination is upheld.

The patient is a male with a history of major depressive disorder (MDD). He had transcranial magnetic stimulation (TMS) and additional sessions were requested to be authorized. There was confusion regarding the authorization and the patient was provided TMS. Additionally, there is concern regarding the need for additional sessions, given the patient's response to a previous trial of TMS.
At issue is the medical necessity for the requested treatment of transcranial magnetic stimulation (TMS), 15 additional units.

The health plan's determination of medical necessity is upheld.

Per the documentation provided, the additional services provided did not result in improvement in the patient's symptoms. The patient did not show improvement with the initial course of TMS. Further sessions of TMS would not have been warranted in less than 6 months' time frame per InterQual criteria particularly given the less than 50% improvement noted in the patient's symptoms with the previous course of TMS. Therefore, it does not appear that it was medically necessary. Additional TMS sessions would have been indicated to maintain an achieved response or improve upon an achieved response.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dental Disorder
Treatment Braces and Office Visits
The insurer denied Braces and Office Visits.
The determination is upheld.

The patient has a Class II cuspid malocclusion, mild maxillary crowding and severe mandibular crowding, and moderate overjet and severe overbite. The issue for review is whether the requested service/treatment, braces and office visits, is medically necessary.

Using the Handicapping Labio-Lingual Deviation (HLD) index, the malocclusion would score a 23 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 millimeters (mm) or greater and underbite 3.5 mm or greater. The 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 standard of care, the requested service/treatment for braces and office visits are not medically necessary.

The health plan's determination is upheld, in whole.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Type I cryoglobulinemic plasma cell dyscrasia. 
Treatment: Inpatient admission. 

The insurer denied coverage for an inpatient admission. 
The denial is overturned. 

This case involves a male who presented to the hospital with progressive weakness and the inability to safely transfer from his wheelchair to his bed along with increased urinary incontinence. He had a history of ischemic infarcts, progressive disability, dyslipidemia, monoclonal gammopathy of undetermined significance, shingles, vitamin B12 (cobalamin) deficiency, and potential mixed connective tissue disease. Records indicated that the patient was unable to move, was previously lucid, but became confused about his surroundings. The patient arrived via ambulance to the emergency department whereupon the patient was admitted with a need for urgent consultation from subspecialty fields of rheumatology, physical medicine rehabilitation, wound management, otology, and neurosurgery. He received advanced diagnostic noninvasive neuroimaging studies, diagnostic cerebral angiography, positron emission tomography/computed tomography, triple spinal fluid analysis, bone marrow biopsy, with extensive serological evaluation, and extensive physical/occupational, and speech therapy assessments. The patient was subsequently diagnosed with RNP (ribonucleoprotein) associated type I cryoglobulinemic plasma cell dyscrasia. He was placed on high-dose prednisone for 5 days, which required constant monitoring for potential adverse side effects, including adverse effects on the healing decubitus pressure ulcer noted on assessment. The patient subsequently discharged to an acute inpatient rehabilitation center. 

The full hospital admission was considered medically necessary for this patient. 

Literature has noted that plasma cell dyscrasia can lead to rare and aggressive plasma cell leukemia that comprises 1% of plasma cell dyscrasias. With the patient's multiple comorbidities, presenting condition, and lack of a confirmed diagnosis, the inpatient care was medically necessary given that the patient's condition was quickly deteriorating, and he required multiple studies, monitoring, and medical care that could not be obtained on an outpatient basis. He was not medically stable to discharge to a lower level of care based upon the provided information. Furthermore, given his administration of high-dose prednisone, this required constant monitoring for potential adverse effects, which had they occurred, would have needed immediate response with appropriate medical care available. Therefore, based upon the provided information, the prior determination should be overturned. 

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

The insurer's denial of coverage for a full hospital is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hypertension, encephalopathy, gout, and hyperlipidemia. 

Treatment: Consumer Directed Personal Assistance Services (CDPAS) 7 days per week, 24 hours per day, continuous care by more than one person; 168 hours per week. 

The insurer denied coverage for Consumer Directed Personal Assistance Services (CDPAS) 7 days per week, 24 hours per day, continuous care by more than one person; 168 hours per week. 

The denial is upheld. 

This is a patient with chronic medical problems including hypertension and encephalopathy. She lives alone in a private residence. The plan approved 7 days/week, 24 hours/day, live in: 91 hours/week. Under review is the requested increase Consumer Directed Personal Assistance Services (CDPAS) 7 days per week, 24 hours per day, continuous care by more than one person: 168 hours per week. 

According to the Uniform Assessment System (UAS) report, the patient cognitive status is described as "minimally impaired" and has not changed. She requires maximal assistance for bathing lower body dressing. Personal hygiene, upper body dressing and toilet transfers require extensive assistance. She is incontinent of bowel and bladder. The patient was also seen by her cardiologist. She was described as "alert and oriented, normal memory." Her gait was "normal." Based on the UAS report and the office visit notes from her treating physician, the currently approved 7 days/week, 24 hours/day, live in; 91 hours/week is clinically appropriate; allowing the patient the ability to continue living safely at home. 

The healthcare plan acted reasonably, with sound medical judgment and in the best interest of the patient. Taken into consideration were the clinical standards of the plan, information provided concerning the patient, the attending physician's recommendation and applicable generally accepted practice guidelines developed by the federal government, national or professional medical society, board and associations. All decisions are evidence-based. From a physical medicine and rehabilitation perspective, the requested increased Consumer Directed Personal Assistance Services (CDPAS) 7 days per week, 24 hours per day, continuous care by more than one person; 168 hours per week, is not medically necessary. 

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

The insurer's denial of coverage for Consumer Directed Personal Assistance Services (CDPAS) 7 days per week, 24 hours per day, continuous care by more than one person; 168 hours per week is upheld. Medical Necessity is not substantiated.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Severe Stricturing Crohn's Colitis
Treatment: Simponi 100mg/ml (milligram per milliliter) Syringe, Pre-service
The insurer denied the Simponi 100mg/ml syringe, pre-service.
The denial is upheld.

The patient is a male who has the diagnosis of severe stricturing Crohn's Colitis. The provider requested treatment with Simponi 100mg/ml (milligrams per milliliter) Syringe. The patient has tried and failed all other treatments as per the appeal letter, with a long list of failed therapies. The plan declined coverage, as Simponi is not FDA (United States Food and Drug Administration)-approved for treatment for Crohn's disease.

No, the health plan should not cover the requested Simponi.

While the provider supplied two articles supporting the use of Simponi in refractory Crohn's, the studies one was observational and suggested further study. There is insufficient medical literature to show that Simponi is appropriate and effective for Crohn's disease patients. Simply because the patient has tried every other medication does not render Simponi an appropriate treatment.

No, the treatment has not been shown to be more effective than currently available medications.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Severe Stricturing Crohn's Colitis
Treatment: Simponi 100mg/ml (milligram per milliliter) Syringe, Pre-service
The insurer denied the Simponi 100mg/ml syringe, pre-service.
The denial is overturned.

The patient is a male with Crohn's disease. The patient has had a small bowel resection, loop colostomy for severe perianal disease and colonic strictures. The patient has failed Asacol, Pentasa, 6-MP (mercaptopurine), Humira, Remicade, Cimzia.

The request is for Simponi.

Yes, the health plan should cover the requested Simponi.

There is literature to support the use of Simponi in Crohn's disease. Furthermore, this patient has failed multiple agents used in Crohn's disease, and he has no reasonable alternatives.

In one study, consecutive patients with Crohn's disease (CD) who were treated at a single IBD (inflammatory bowel disease) center with golimumab during a six year period were included in a retrospective observational study. Clinical response was defined as a significant reduction in symptoms and biochemical markers of CD (Crohn's disease), with no requirement for surgery or introduction of immunomodulators. Forty-five patients were included, with a median follow-up of 22 months (interquartile range 1234) following initiation of golimumab. All patients had previously failed at least 2 anti-TNF (tumor necrosis factor) agents. In 64% (percent) of patients, anti-TNF (tumor necrosis factor) failure was associated with loss of response and in 23% due to adverse effects. Clinical response at 6 months was achieved in 32/45 (71%) patients. The cumulative probabilities that patients maintained their clinical response for 12 and 36 months after the introduction of golimumab were 79% and 65%, respectively. (Greener T., et al. P615 Abstract. European Crohn's and Colitis Organization. 2017.)

In another prospective observational study, all patients studied had failure of infliximab, adalimumab, and azathioprine/6-mercaptopurine. Seventy percent of patients achieved clinical response with Simponi and 40% were in steroid-free remission at 12-16 weeks. (Bohm M, Am J Gastroenterol).
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Severe Stricturing Crohn's Colitis
Treatment: Simponi 100mg/ml (milligram per milliliter) Syringe, Pre-service
The insurer denied the Simponi 100mg/ml syringe, pre-service.
The denial is overturned.

The patient is a male with moderate to severe Crohn's. He has failed steroids, Asacol, Pentasa, 6-MP (mercaptopurine), Remicade, Humira, Cimzia, Entyvio, Methotrexate and Stelara. His provider is requesting treatment with Simponi.

Yes, the health plan should cover the requested Simponi.

The patient has severe Crohn's and has failed all FDA (United States Food and Drug Administration)-approved therapy. Surgery is a last resort for Crohn's, and it will come back in other parts of the GI (gastrointestinal) tract from the mouth to the anus, and surgery is only recommended when there is perforation, refractory bleeding, fistula or obstruction.

A Swedish study of patients with refractory Crohn's showed more than one-third of the patients treated with Simponi were evidenced to have had clinical benefit after a median follow-up of more than 1.5 years. [4]

A French study showed that after failure of infliximab or adalimumab for Crohn's disease, Simponi was safe and seemed beneficial in half of the patients. [3]

Therefore, as there are no other FDA (United States Food and Drug Administration)-approved treatment options, and as Simponi is an anti-TNF (tumor necrosis factor) like Remicade and Humira, which are used in Crohn's, and as there is medical literature supporting its use in refractory cases, the health plan should cover Simponi.

There are no other standard treatments for Crohn's that the patient has not already tried and failed.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Hypertension.
Treatment: Bystolic 10mg tablet.
The insurer denied Bystolic 10mg tablet.
The determination is overturned.

The patient has a history of essential hypertension treated for the last decade successfully with Bystolic 10 milligrams (mg) daily. Previously, the patient was treated with nebivolol, atenolol, metoprolol but experienced significant side effects to these agents including severe headaches and nausea prompting discontinuation. The patient's provider has requested a prescription benefit formulary exception for Bystolic 10 mg but it has been denied by the health plan as not meeting plan criteria. At issue is whether the formulary drugs will be or have been ineffective, would not be as effective as the non-formulary drug (Bystolic 10 mg), or would have adverse effects.

Yes, the formulary drugs will be or have been ineffective, would not be as effective as the non-formulary drug (Bystolic 10 mg), or would have adverse effects. The information provided for review of this case document that this patient has previously tried 3 of the formulary alternatives but did not tolerate them due to significant adverse effects causing severe headaches and nausea. The patient has been doing well on treatment with Bystolic 10 mg and it is an appropriate medication for treatment of her hypertension (1).
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Acne.
Treatment: Retin-a micro.
The insurer denied the Retin-a micro.
The determination is upheld.

The patient has acne vulgaris. The acne is described as post-inflammatory hyperpigmentation, scars, and cysts on the face. She was also prescribed spironolactone. The provider is a dermatologist. The medication under review is Retin-a micro.

The formulary drugs adapalene (except adapelene pads or adapelene solution, benzoyl peroxide, clindamycin gel, clindamycin solution, clindamycin benzoyl peroxide (generic Acanya, Benzaclin), erythromycin solution, erythromycin benzoyl peroxide, tazarotene cream (generic Tazorac), tretinoin, tretinoin gel, and microsphere will not be ineffective, and have not been trialed and shown to be ineffective.  The formulary drugs would be as effective as the non-formulary drug Retin A Micro, and would not have adverse effects.
The clinical guidelines for acne vulgaris recommend tretinoin gel as first line topical therapy for acne vulgaris (1-3).  Zaenglin et al writes in the "Guidelines of care for the management of acne vulgaris," published in the Journal of the American Academy of Dermatology, that tretinoin gel is effective for acne management (1).  Additionally, within the evidence-based literature, according to Bolognia et al, Lebwohl et al, and James et al generic tretinoin such as the formulary alternative tretinoin gel is supported as effective therapies for acne (3-5).
The preferred agents are appropriate agents for the treatment of the patient's acne.  The formulary medications should be tried and failed prior to initiating the Retin-a micro.  After review of the clinical documentation, there is no documentation provided that would justify the patient requiring treatment with the Retin-a micro prior to the formulary alternatives such as tretinoin gel.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Chronic Low Back Pain

Treatment: 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance: first 2 vertebral bodies, lumbar or sacral (Intracept).

The insurer denied coverage for 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance: first 2 vertebral bodies, lumbar or sacral (Intracept).

The denial is overturned

The patient has chronical low back pain. The patient underwent a magnetic resonance imaging (MRI) of the lumbar spine that revealed post-surgical changes at the lumbar (L)4-L5 and L5-sacral (S)1 levels. The presences of spinal cord stimulator hardware were also seen. At thoracic (T)12-L1, the patient had type II Modic endplate changes at T12 -L1 with mild to moderate stenosis. At L3-L4, there was type I Modic endplate changes with moderate to severe stenosis. The patient was seen for low back pain radiating to the left leg. On examination of the lumbar spine, there was tenderness to palpation, reduced range of motion, and intact neuro exam. Current request is for Intracept procedure. 

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcome.

The request for 64628 (Intracept) does have final approval from the appropriate regulatory bodies for this diagnosis.

The procedure received Food and Drug Administration (FDA) approval. This is based on improved Oswestry Disability Index (ODI) and visual analog scale (VAS) scores sustained at 24 months (Reference 1). The patient tried conservative measures and injections prior to this point. Her options now include surgery or stronger medications, and she does not want to proceed to surgery or risk addiction with controlled substances.

The patient meets the criteria used for inclusion in the studies. She has chronic low back pain (LBP) of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1 (Reference 2, 3, & 4).

The patient fits the patient selection criteria used in the studies of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. She has axial low back pain and MRI findings consistent with the inclusion criteria. This is a reasonable therapy wit h studies that prove efficacy and is less invasive than the alternative, spinal fusion.

The request for 64628 (Intracept) is the best available treatment for this patient at this time.

The adverse risks are not increased over standard treatment/services. The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept) should be overturned.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Chronic Low Back Pain

Treatment: 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance: first 2 vertebral bodies, lumbar or sacral (Intracept).

The insurer denied coverage for 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance: first 2 vertebral bodies, lumbar or sacral (Intracept).

The denial is upheld

This patient has chronic low back pain and is status post laminectomy at lumbar (L)4-L5 and L5- S (sacral)1. She has tried Chiropractic, Home exercise, Physical Therapy, Epidural steroid injection, radiofrequency ablation (RFA) of the medial branches and also has a Spinal Cord stimulator in place. She has tried multiple medications including Gabapentin, Methylpredniscolone, NSAIDs (Non-Steroidal Anti-inflammatory Drugs), Tizanidine and Oxymorphone. On MRI (magnetic resonance image) she has faint Modic Type 1 changes at the L3 end plate and Modic type I at thoracic (T)12-L1. The request is for RFA of the basivertebral nerve.

In 2018, Fischgrund and colleagues (1) published a double-blind, sham controlled RCT [randomized controlled trail] evaluating the Intracept system and RF [radiofrequency] ablation of the Basivertebral nerve for the treatment of chronic low back pain. A total of 225 participants with chronic (>= 6 months) isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham (n=78) or treatment (n=147) intervention. In the active treatment group, the RF probe was activated and the temperature at the tip was maintained at 85C (Celsius) for 15 minutes. The duration of the session in the sham group was the same but the RF treatment was only simulated. Study participants had a minimum Owestry disability index (ODI) of 30 points (on 100-point scale) and a minimum VAS [visual analog scale] of 4 cm (10 cm scale). The primary efficacy endpoint was the comparative change in ODI from baseline to 3 months. Both intention-to-treat (ITT) and per protocol (PP) analysis were pre-planned. A total of 19 of 147 (13%) participants in the treatment group were excluded from the PP analysis; 16 for a targeting failure, 1 for procedural failure and 2 for protocol non- compliance. One participant in the sham group was excluded from the PP analysis and this was for protocol non-compliance.

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.

The carrier's denial of 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept) should be upheld.