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

Diagnosis:  Crohn's disease.
Treatment:  Remicade.

The insurer denied Remicade.  The determination is overturned.

This is a male patient with Crohn's disease, status post ileostomy, full proctocolectomy, and multiple bowel surgeries resulting in short bowel syndrome and unintentional weight loss. He failed azulfidine and was started on Remicade, with good response and long-term clinical remission. Computed tomography enterography showed suspicion of mild active inflammation in the mid- to distal small bowel, greatest in the left lower quadrant. The patient is taking Remicade 5 milligrams per kilogram (mg/kg) every 8 weeks for the treatment of Crohn's disease. The formulary alternative is Inflectra. At issue is the medical necessity of Remicade.

Yes, the continued use of Remicade is medically necessary in this case.

A change from Remicade to a biosimilar (Inflectra) in this patient with Crohn's disease is at issue. Inflectra, Avsola, and Renflexis are Food and Drug Administration (FDA) approved biosimilars to Remicade (infliximab) for the treatment of Crohn's disease and Ulcerative Colitis. Support for the safety and efficacy of biosimilar medications in inflammatory bowel disease is provided by studies which either extrapolated safety and efficacy from patients with other diseases (such as rheumatoid arthritis), or from studies in patients who had controlled inflammatory bowel disease; many of these trials are underpowered to assess for noninferiority in inflammatory bowel disease patients [1]. Additionally, multiple studies have shown that patients who continued Remicade had a lower risk of disease worsening or treatment discontinuation, including a fivefold hazard of discontinuing treatment at 12 months, but these did not reach statistical significance [1,2]. Assumptions about switching patients from Remicade to a biosimilar should be made with caution, as a lack of inflammatory bowel disease control can result in significant adverse events such as disease flare, fistula, stricture, toxic megacolon, dysplasia leading to colorectal cancer, need for surgery, and need for hospitalization [3-5]. Additionally, American College of Gastroenterology guidelines for the treatment of Crohn's disease state that "Insufficient data exist to support the safety and efficacy of switching patients in stable disease maintenance from one biosimilar to another of the same biosimilar molecule" [6]. Although there is support for initiation of therapy with an infliximab biosimilar rather than Remicade, there is a lack of high-quality data or large studies to support the safety of a switch from one biosimilar to another in Crohn's disease in remission [7,8]. A change from Remicade to Inflectra may result in loss of remission, and significant adverse events such as disease flare, fistula, stricture, toxic megacolon, dysplasia leading to colorectal cancer, need for surgery, and need for hospitalization. For these reasons, the request for continuation of Remicade is medically necessary in this patient currently stabilized on Remicade.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Diabetes.
Treatment:  Onglyza 5 milligram tablets.

The insurer denied Onglyza 5 milligram tablets.  The determination is upheld.

This patient has a history of diabetes and is currently taking Onglyza. The patient has had diarrhea with Januvia and Janumet. Patient has also tried metformin and Farxiga. At issue is the requested non-formulary drug, Onglyza 5 milligrams (mg) tablets.

This request is for the continuation of Onglyza. The formulary alternatives are Januvia and alogliptin. The patient tried and was intolerant to Januvia due to diarrhea. The submitted documentation does not indicate that the patient has tried alogliptin. The patient does not have a documented contraindication to alogliptin. Alogliptin is in the same drug class as Onglyza and is expected to have similar safety and efficacy as Onglyza. The American Diabetes Association clinical guidelines do not recommend the use of Onglyza over alogliptin in this clinical situation. Therefore, no, alogliptin has not been and is not expected to be ineffective as compared to Onglyza or have adverse effects.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's.  
Treatment: Skyrizi. 

The insurer denied Skyrizi. The health plan's determination is overturned. 

The patient is a female with Crohn's disease (ileitis with enteropathic arthritis). She presented with ongoing symptoms - abdominal pain, cramping, bloating worse with food, intermittent diarrhea, and significant joint pain. She attempted prednisone with only marginal improvement in symptoms. She had elevated C-reactive protein of 6.3. 

The current medical literature supports the use of Skyrizi as medically necessary in this case. 

Large, high-quality randomized controlled trials have demonstrated safety and efficacy for induction and maintenance of remission in patients with moderate-severe Crohn's disease; Skyrizi achieved high rates of clinical and endoscopic remission. The patient warrants therapy for Crohn's disease according to guidelines, which do not recommend alternatives such as corticosteroids as chronic therapy, and do not recommend immunosuppressants for induction of remission. Lack of effective therapy may result in Crohn's disease symptoms and complications such as disease flare, hospitalization, need for surgery, fistula, and stricture; subcutaneous dosing cannot be used without intravenous induction doses. For these reasons, the request for Skyrizi is supported as medically necessary for the treatment of this patient's Crohn's disease.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Paroxysmal atrial fibrillation
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is upheld

The patient is an adult male with a past medical history of diabetes, hypertension, and paroxysmal atrial fibrillation who presented to the hospital for an elective cardiac catheterization. 
He was experiencing episodes of chest pain for which a stress test was obtained 7 months ago, and it demonstrated evidence of moderate anterior wall ischemia. Consequently, left heart catheterization was recommended for further evaluation. The patient was admitted to the hospital and underwent cardiac catheterization which demonstrated an occlusive lesion in the diagonal artery which was treated with a drug-eluting stent. Subsequently, the patient was started on guideline directed medical therapy for coronary artery disease and was discharged with outpatient follow-up.

The proposed inpatient hospital admission was not medically necessary.

The patient was hemodynamically stable and was not hypoxic. There was no evidence of sepsis, no mental status changes and no end organ malperfusion. The patient did not have acute coronary syndrome and there was no evidence of unstable angina given that he did not have acute ST changes on his electrocardiogram (EKG) and there was no evidence of chest pain at rest. Furthermore, the patient did not have any periprocedural complications related to his cardiac catheterization. Consequently, based on the provided documentation, there is insufficient clinical data to support medical necessity for inpatient level of care. Observation level of care would have been appropriate in this case.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriasis

Treatment: Tremfya 100MG/ML (milligrams per milliliters) SC (subcutaneously) SOPN (solution pen injector)

The insurer denied: Tremfya 100MG/ML (milligrams per milliliters) SC (subcutaneously) SOPN (solution pen injector)

The denial is overturned.

The patient is an adult female with severe psoriasis that affects 15% (percent) BSA (body surface area). She has tried and failed methotrexate, adalimumab, secukinumab and multiple topical steroids. The request is for Tremfya (guselkumab) injections.

The requested Tremfya is medically necessary.

The patient has failed a TNF (tumor necrosis factor) alpha inhibitor (adalimumab) and an IL17 (interleukin 17) inhibitor (secukinumab). It is not medically appropriate to request for her to fail two additional TNF (tumor necrosis factor) alpha inhibitors prior to trying a medication with a different mechanism of action than one she has already failed. Tremfya has proven to be more effective in the treatment of psoriasis than the available alternatives. Two phase 3, multicenter, randomized, double-blind, placebo and active comparator-controlled studies, VOYAGE 1 AND VOYAGE 2, evaluated the efficacy and safety of TREMFYA compared to placebo and adalimumab in patients with moderate to severe plaque psoriasis (PsO). In both studies, significantly more patients receiving TREMFYA achieved the coprimary endpoints of an IGA (Investigator's Global Assessment) score of cleared (0) or minimal (1) and 90% improvement in Psoriasis Area and Severity Index (PASI 90) response at week 16 versus placebo (P [less than] 0.001). IGA (Investigator's Global Assessment) 0, IGA (Investigator's Global Assessment) 0 or 1, and PASI (Psoriasis Area and Severity Index) 90 responses were also significantly higher in patients receiving TREMFYA versus adalimumab throughout the studies (P [less than] 0.001). A Network Meta-Analysis (NMA) compared first-in-class interleukin (IL)-23 inhibitor TREMFYA (guselkumab) to all advanced therapies approved for active psoriatic arthritis using data from 33 Phase 3 randomized clinical trials. The NMA (Network Meta-Analysis) concluded TREMFYA ranked highest for skin clearance based on Psoriasis Area Severity Index (PASI) 90 response among 23 treatment regimens (15 unique treatments including IL [interleukin]-23 inhibitors like TREMFYA and risankizumab, subcutaneous tumor necrosis factor inhibitors, and Janus kinase inhibitors).
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoraisis

Treatment: Skyrizi 150 mg/ml (milligrams/milliliter) SC (subcutaneous) SOSY (solution prefilled syringe)

The insurer denied coverage for Skyrizi 150 mg/ml (milligrams/milliliter) SC (subcutaneous) SOSY (solution prefilled syringe)

The denial is overturned.

 
The patient is an adult male with a history of severe psoriasis who has failed therapy with numerous topical steroids, Humira, and Cosentyx.  The requested medication is Skyrizi.  

Based on the submitted documentation, Skyrizi is medically necessary.  The patient has failed topical therapy and requires systemic therapy for control and management of his psoriasis diagnosis. The patient has tried and failed topical agents as well as biologics, including Humira and Cosentyx.  Skyrizi is Food and Drug Administration (FDA) approved for treatment of psoriasis vulgaris and it is reasonable to attempt this treatment option.  

The joint American Academy of Dermatology-National Psoriasis Foundation (AAD-NPF) guidelines for psoriasis treatment with biologics states, "An randomized controlled trial (RCT) assigned 166 patients to receive Risankizumab (Skyrizi) subcutaneously (a single 18-mg dose at week 0 or 90-mg or 180-mg doses at weeks 0, 4, and 16) or ustekinumab (Stelara) (45 or 90 mg [depending on body weight] at weeks 0, 4, and 16). At week 12, 77% (percent) of patients receiving risankizumab (the 90-mg and 180- mg groups pooled), as compared with 40% in the ustekinumab-treated group, achieved Psoriasis Area and Severity Index (PASI 90 ) (90 percent improvement); in contrast, 45% in the pooled groups treated with 90 mg and 180 mg of risankizumab, as compared with 18% in the ustekinumab-treated group, achieved PASI 100.  

In this case, Skyrizi is a reasonable next therapy for the treatment of the patient's disease and is medically necessary having failed therapy with Humira and Cosentyx.  As such, Skyrizi is approved based on the current evidence-based medical literature.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Skyrizi 150 mg/ml SC SOSY is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Broken Ribs
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is upheld.

The patient is an elderly male. The patient had an inpatient hospital admission for the diagnosis of fractured ribs. The patient has a past medical history of cardiac stents and is on aspirin and Plavix. The patient also has a past history of hypertension and high cholesterol. The patient stood on the hood of a car to reach something and sustained a fall. The patient had a laceration to the forehead but denies any loss of consciousness. The patient struck his chest and left side of the face. A CT (computed tomography) scan and chest x-ray revealed multiple left-sided rib fractures of 5-9 with no pneumothorax or effusion. The patient was breathing well with moderate left-sided chest pain. The patient had a cardiac catheterization with stents approximately three weeks prior to this admission. Chest and head CT (computed tomography) were negative, and the CT (computed tomography) of the spine was negative. The patient was admitted for observation. The patient was hemodynamically stable and did not have any respiratory conditions. The patient did have pain complaints. The patient was evaluated by physical therapy and was cleared for discharge to home. The patient maintained medical stability and was discharged on Day #3. This is a review for the inpatient level of care.

The Inpatient Hospital Admission was not medically necessary.

The patient did not require inpatient level of care, based upon the severity of the injury. The patient sustained multiple rib fractures after a fall and was admitted for observation. This was necessary to ensure that the patient did not have any late reactions especially due to the history of anticoagulation. However, this did not require acute inpatient level of care. The patient did not develop any complications and had no respiratory conditions or severity of pain symptoms that would require an inpatient level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Failing denture. 
Treatment: Bone Replacement Graft For Ridge Preservation, 
per site (D7953) Guided Tissue Regeneration, Natural Teeth-Resorbable Barrier, per site (D4266). 

The insurer denied: Bone Replacement Graft For Ridge Preservation, per site (D7953) Guided Tissue Regeneration, Natural Teeth-Resorbable Barrier, per site (D4266). 

The denial is overturned. 

The patient is an elderly male who had a failing lower partial denture secondary to non-restorable teeth. The teeth were removed, the areas grafted, and osseointegrated implants placed to support an overdenture. The grafting and membranes placed over the teeth was denied coverage by the health plan, because it did not meet plan guidelines. Specifically, the denial was because "only one regenerative procedure per site (or tooth) is allowed." The denial is being appealed. 

The requested health service was medically necessary. 

The placement of the graft was necessary to maintain both height and volume of the proposed implant sites. The barrier membrane was used for the purpose of covering and maintaining the graft material. The membrane was not used as a regenerative material - it was a resorbable membrane that prevented the graft material from being washed away. The standard of care and literature require that something be placed over the graft material - this can be a soft tissue graft or a resorbable or non-resorbable material - that will protect the graft. If not done, the graft material would be gone in a matter of days. 

The description for code D7953 clearly states that if a membrane is used it should be reported separately - this is what was done. 

Therefore, given the above, the requested health service was medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Asthma
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is Upheld

This teenaged female with a history of asthma and multiple prior admissions presented with cough, chest tightness, sore throat and shortness of breath. Her vital signs were stable and she was afebrile. The patient's respiratory rate was 22; her heart rate was 115; oxygenation was 95%. The patient's exam showed end expiratory wheezes and the patient was able to speak in full sentences. The patient's pertinent labs included white blood cell (WBC) count of 10.43, potassium of 3.4, and carbon dioxide (CO2) was 18. In the emergency department, the patient as positive for rhino/enterovirus. She was treated with three combination nebulizers. Chest x-ray showed right-sided pneumonia. The patient was admitted with asthma exacerbation. Plan of care included intravenous antibiotics, albuterol every three hours, and Flovent twice daily. This treatment was continued for 3 days. The patient was transitioned to oral medications and was discharged on day #3.

The proposed treatment was not medically necessary. 

This patient with a history of asthma was admitted after presenting with asthma exacerbation. She has no history of intubation. She was hemodynamically stable and afebrile. 
Evaluation showed the patient to have tachycardia and tachypnea. The patient had normal oxygenation and was speaking in full sentences. The patient was treated with duoneb three times in the emergency department. She was positive for rhino/enterovirus and found to have pneumonia. The patient did not require ventilatory support. The patient had not failed an observation level of care. She remained clinically stable during hospital stay. The inpatient hospital admission was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dental Problems/Other/Unnrestored implants
Treatment: Dental/Orthodontic Procedure/D2393 3 surface white filling on back tooth for teeth 21 and 29. 
The health plan denied the requested D2393 3 surface white filling on back tooth for teeth 21 and 29 as not medically necessary. 
The health plan's determination is upheld.

The patient is a male who presented to the office for the treatment of teeth #21 and 29. Provided for review are multiple pages of previous denials of benefits, clinical notes, radiographic images, letters from medical providers regarding the need to replace missing teeth, and varying treatment plans within the notes. There is no claim form indicating the final requested treatment despite additional requests for clarification. From the notes, there have been plans for full coverage crowns on #29 and enameloplasty on 21, but no final decision on which direction treatment is going nor requested.
At issue is the medical necessity for the requested health service/treatment of D2393 3 surface white filling on back tooth for teeth 21 and 29.

I uphold, in whole, the health plan's determination of medical necessity.

There is no requested service, there is only conflicting plans with no decided upon treatment. There has not been a definitive plan decided upon and no specific codes requested; medical necessity cannot be established.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Decreased mobility
Treatment: Consumer Directed Personal Assistance Services (CDPAS): 7 Days per Week, 12 Hours per Day - Total of 84 Hours per Week.
The insurer denied Consumer Directed Personal Assistance Services (CDPAS): 7 Days per Week, 12 Hours per Day - Total of 84 Hours per Week. 
The health plan's determination is overturned. 

This is a case review for a female with medical history notable for mobility issues, dementia, and incontinence. The patient is approved for 6 hours per day, 7 days per week (42 hours per week) of Consumer Directed Personal Assistance Services (CDPAS). The patient and her care team requested an increase to 12 hours per day, 7 days per week (84 hours per week) and this request was denied by the health plan. 

The Consumer Directed Personal Assistance Services (CDPAS): 7 Days per Week, 12 Hours per Day - Total of 84 Hours per Week is medically necessary for this patient.
The patient has advanced dementia and incontinence. She requires hands-on assistance for all activities of daily living including transfers and toileting. She cannot direct her own care. It is not reasonable for her to be left alone for the majority of the day. Her falls when left alone are evidence of unmet personal care needs. Her functional needs can be expected to be continuous and unscheduled in nature, and she should have a home health aide available to provide for needs such as toileting. Failure to provide for these personal care needs could result in skin breakdown and/or infection.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Class II molar and canine relationship
Treatment: Braces and Monthly Visits
The insurer denied: Braces and Monthly Visits
The denial is overturned

The patient is an adolescent female; the request is for orthodontic benefits and monthly visits. The patient has a Class II molar and canine malocclusion with maxillary and mandibular spacing. The patient has impacted upper permanent canines. The prior denial was due to a handicapping index score of 10.

The proposed treatment is medically necessary.

The patient has impacted upper permanent canines. When there is an impacted permanent anterior tooth, where extraction is not indicated, that is an "automatic qualifier". This patient has two impacted permanent anterior teeth that should not be extracted. This case has medical necessity. Orthodontic treatment and monthly follow up visits are needed to correct the malocclusion.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Malocclusion
Treatment: Insertion of braces (Comprehensive orthodontic treatment of adolescent dentition) and Adjustment of braces (Periodic orthodontic treatment visit)
The insurer denied coverage for insertion of braces (Comprehensive orthodontic treatment of adolescent dentition) and Adjustment of braces (Periodic orthodontic treatment visit).
The denial is upheld. 

Upon review of the submitted documentation, (study models were not provided for review), 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, New York State requires the use of an orthodontic Index, the Handicapping Labio-Lingual Deviation Index Report (HLD, New York State Medicaid program) modeled after the Handicapping Labiolingual Deviation Index. This index provides six specific conditions that automatically qualify for orthodontic care. Additional criteria are used which utilize 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 automatically qualifying condition criterion is not met as there is no evidence of soft tissue damage severe or otherwise and does not support comprehensive orthodontic care using this criterion. In this case, the clinical circumstance does not meet insurer and plan criteria to justify orthodontic care.

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 referenced studies (1, 2, 3). 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. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for insertion of braces (Comprehensive orthodontic treatment of adolescent dentition) and Adjustment of braces (Periodic orthodontic treatment visit) is not substantiated.