Persius/imr-appeals huggingface dataset:
Diagnosis: Rheumatoid Arthritis
Treatment: Orencia 
The insurer denied Orencia.
The determination is upheld.


This is a female patient with rheumatoid arthritis (RA). Prior treatments included Cimzia, intravenous (IV) Orencia, subcutaneous (SQ) Orencia and Plaquenil (stopped due to gastrointestinal (GI) side effects). The patient has been on Orencia in the past and her provider would like to re-start it. Subcutaneous (SQ) Orencia is being denied by the health plan as the preferred formulary drugs have not been tried. The primary preferred formulary drugs, include Humira, Hyrimoz, Rinvoq and Xeljanz. The secondary preferred drug is Kevzara. Of note, the patient has a latex allergy. At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.

All formulary medications would be as effective for the treatment of RA. However, Humira and hyrimoz (Humira biosimilar) are not options as the patient has a latex allergy and the needle cover of prefilled syringe and autoinjector of these medications may contain latex. Xeljanz, Rinvoq and Kevzara do not contain latex and thus there is no medical reason the patient cannot try one of these preferred medications as they are indicated for the treatment of RA. For example, as published in N Engl J Med in 2012, "in patients with active rheumatoid arthritis, tofacitinib monotherapy was associated with reductions in signs and symptoms of rheumatoid arthritis and improvement in physical function". Moreover, a paper in Arthritis Rheumatol in 2017 concluded that "sarilumab 150 milligrams (mg) and sarilumab 200 mg every 2 weeks plus conventional synthetic disease modifying anti-rheumatic drugs (DMARDs) improved the signs and symptoms of RA and physical function in patients with an inadequate response or intolerance to anti-tumor necrosis factor (TNF) agents. Safety data were consistent with interleukin-6 receptor blockade and the known safety profile of sarilumab". Like Orencia, Xeljanz, Rinvoq and Kevzara would need to be stopped when pregnant as well. As stated, Humira is not an option due to the patient's latex allergy. There is no reason the patient cannot try one of the latex free drugs on the health plan's formulary.
Diagnosis: Toenail fungus
Treatment: Jublia 
The insurer denied Jublia.
The determination is upheld.

The patient is a female who was treated for toenail fungus. She was treated with ciclopirox topical medication. She was also given Itraconazole. She had been treated by a different podiatrist and tried Formula 3 and terbinafine orally with minimal improvement. The patient was recommended and prescribed Jublia. At issue is whether the formulary drugs will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.

Based on the review of medical records, standards of care, and literature, all of the formulary drugs (Kerydin, tavaborole solution, terbinafine tablets, itraconazole tablets and ciclopirox) are known to be as effective as or more effective then the non-formulary drug. The patient has tried terbinafine tablets, itraconazole tablets, and ciclopirox solution. However, the patient does not have documentation of trying Kerydin or tavaborole solution.
Diagnosis: Duchenne Muscular Dystrophy	

Treatment: 39 Home Health Visits

The insurer denied coverage for 39 Home Health Visits

The denial is upheld 

This is a patient diagnosed with Duchenne Muscular Dystrophy (DMD). The patient is dependent for activities of daily living (ADL) and non-ambulatory. Under review is the medical necessity of occupational therapy (OT) 39 home health visits.

The clinical records submitted are insufficient to support the medical necessity for the requested OT services. The letter from the patient's treating physician describing the patient's underlying diagnosis (DMD), limited functional ability, and reported medical necessity of physical and occupational therapy was reviewed. Also reviewed were the office visit notes and "Video-Visit note". According to the notes, the patient "has been going for physical therapy (PT)/OT 3 times a week."  The provider also includes medical literature regarding the diagnosis, management and rehabilitation of DMD (1, 2). However, the actual PT/OT notes, which require evidence of continued and sustained functional improvement, were not included for review.   

The health plan acted reasonably, with sound medical judgment and in the best interest of the patient. Taken into consideration were including but not limited to, the clinical standards of the plan, the information provided concerning the patient, the attending physician's recommendation and applicable generally accepted practice guidelines developed by the federal government, nation or professional medical societies and boards. All decisions are evidenced based. 

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 occupational therapy 39 home health visits is not substantiated.
Diagnosis: Malocclusion

Treatment: D8080 Braces and D8670 monthly visits

The insurer denied coverage for D8080 Braces and D8670 monthly visits

The denial is upheld. 

Upon review of the submitted documentation including lateral cephalometric radiograph, panoramic radiograph, montage of extraoral and intraoral clinical images, orthodontist treatment records, appeal letter the patient's orthodontist with references, as well as insurer correspondence, it appears that this patient with muscular dystrophy, presented for evaluation for orthodontic care. The orthodontist identified several clinical findings including mandibular protrusion, open bite, and anterior crowding and has recommended orthodontics. The orthodontist has completed the Handicapping Labio-Lingual Deviation (HLD) index attaining 36 total points to support orthodontic care. 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 7 points by internal reviewers. The orthodontist is appealing the decision.

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, New York State requires, as of September 1, 2012, the use of an orthodontic Index, the Handicapping Labio-Lingual Deviation Index. Report (HLD, New York State Medicaid program) modeled after Handicapping Labio-Lingual Deviation Index. 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 36 points to justify orthodontic care. The reviewer concurs with the index completed by the insurer attaining a total of 7 points on the HLD index (2 overjet, 2 overbite, 3 labiolingual spread) which is below the threshold of 26 points to support orthodontic care. 

Regarding the validity of the Handicapping Labio-Lingual Deviation 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. 

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 D8080 Braces and D8670 monthly visits is not substantiated.
Diagnosis: Multiple Sclerosis

Treatment: Subacute rehabilitation

The insurer denied coverage for subacute rehabilitation

The denial is upheld 

This is a patient with diagnosed multiple sclerosis and more recently urinary tract infection(s).  The patient's ability to perform activities of daily living (ADLs) and functional mobility has gradually declined.  The patient was admitted (from home) to the skilled nursing facility (SNF).  The patient received physical and occupational therapy.  Under review is the medical necessity for subacute rehabilitation.

The submitted SNF records do not support that the patient continued to be an appropriate candidate for the subacute rehabilitation SNF level of care during the time period under review (1, 2, 3).  The patient presented from home to the skilled nursing facility (SNF).  Upon presentation, the patient required a foley urinary catheter and drainage bag.  The patient's ability to perform activities of daily living and functional mobility ranged from maximal assistance to total dependence.  

Over the next several weeks, the foley catheter was eventually removed, and the patient was able to urinate on their own.  Unfortunately, the patient's ability to perform activities of daily living and functional mobility had demonstrated only limited improvement.  According to the physical therapy notes, the patient was unable to ambulate with or without an assistive device.  The patient required the assistance of 2 people, an Eva support walker and a wheelchair followed close behind; being upright for approximately 15 feet.  The patient also required 2 people to transfer from sitting to standing.  A similar lack of progress was documented by the occupational therapist.  The patient continued to require moderate to maximal assistance for bathing, dressing and toileting activities. Subsequent treatment for the time period under review could have been safely provided at a lower level of care (e.g., long term care or home care with visiting therapy services). There were also no other specific acute medical or complicated nursing issues that warranted continued subacute rehabilitation level of care for the time period under review.  

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 subacute is not substantiated.
Diagnosis: Obesity and pre-diabetes.

Treatment: Wegovy 2.4 mg/0.75 ml, pen injectors.

The insurer denied coverage for Wegovy 2.4 mg/0.75 ml, pen injectors.

The denial is upheld.

This is a patient diagnosed with obesity. This request is for Wegovy. As per the visit note, the patient had pre-diabetes with a hemoglobin A1C of 5.4%, dyslipidemia, obstructive sleep apnea (OSA), and hypertension (HTN). The patient is on Ozempic 2 milligrams (mg) weekly. The patient is noticing with Ozempic some stomach cramps and loose stools. 

The patient's starting weight was 293 pounds (lbs.). On subsequent visits, the patient's weights and body mass index (BMI) were: 262.4 lbs., BMI 33.7; 262.8 lbs., BMI 33.7; and most recently, 258 lbs., BMI 33.1. 

Semaglutide is a glucagon-like peptide 1 receptor (GLP1R) agonist that is approved by Food and Drug Administration (FDA) in treating type II diabetes and obesity. Recent studies published in major peer-reviewed medical journals have shown safety and efficacy of semaglutide for the treatment of obesity. This medication is now available for treating obesity in the form of Wegovy. The standard of care based on multiple societal guidelines requires that the patient participate in lifestyle modification. It also requires that the patient has a BMI of 30 or greater or a BMI of 27 or greater with comorbidities such as hypertension and hyperlipidemia. 

The patient had a BMI of 33.1 recently; however, there is no documentation of participation in lifestyle modifications. 

Based on the above, the insurer's denial must be upheld. The health care plan acted reasonably and with sound medical judgment and in the patient's best interest. The medical necessity for Wegovy 2.4 milligrams (mg)/0.75 milliliters (ml), pen injectors services is not substantiated.
Diagnosis: Decreased mobility. 
Treatment: Personal Care Services Level 2: 11 Hours per day, 7 Days per Week - Total of 77 Hours per Week. 
The insurer denied Personal Care Services Level 2: 11 Hours per day, 7 Days per Week - Total of 77 Hours per Week. 
The health plan's determination is overturned. 

This is a case review for a male with medical history notable for mobility issues, incontinence, and end stage renal disease. The patient and his care team requested Personal Care Services. 

The Personal Care Services Level 2: 11 Hours per day, 7 Days per Week - Total of 77 Hours per Week service is medically necessary for this patient. 
The patient requires personal care assistance for nearly all activities of daily living, including ambulating, toileting, and transfers. Given that some of these personal care needs will be unscheduled throughout the day, the requested increase from 7 to 11 hours per day is reasonable and appropriate to meet the patient's functional needs. The most recent Uniform Assessment System (UAS) functional assessment reports that there was no significant functional decline, however in the text of the assessment it does report that his functional status has been worsening and that he does require personal care assistance with all activities of daily living. The increase in hours is therefore medically necessary and appropriate for the patient. His fall in the previous 30 days before the assessment is evidence of unmet personal care needs, as he requires assistance with ambulation and further attempts to do so without assistance could result in additional injuries.
Diagnosis: Decrease in kidney function
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is upheld.

The patient is an adult female who was admitted for worsening kidney function on outpatient labs with hyperkalemia. She was evaluated by nephrology service and was started on intravenous fluid and treated with Lokelma for elevated potassium level. The patient was noted to have adequate urine output and her creatinine was trending down appropriately, which was consistent with prerenal azotemia. Her condition stabilized and she was discharged on day #4.

The requested health service was not medically necessary.

The patient was admitted for dehydration and was noted to have elevated creatinine; however, the patient's acute kidney injury could have been treated safely under a lower level of care. The gold standard for the distinction between prerenal disease secondary to volume depletion and post-ischemic and nephrotoxic acute tubular necrosis (ATN) is the response to fluid repletion per Kidney Disease Improving Global Outcomes (KDIGO) and National Kidney Foundation guidelines. If sufficient fluid is given to reverse any signs of volume depletion (e.g., hypotension, cool extremities, low urine-sodium concentration), return of the serum creatinine to the previous baseline within 24 to 72 hours is considered to represent a correction of prerenal disease, whereas persistent acute kidney injury (AKI) is considered to represent acute tubular necrosis. This patient's kidney function improved back to baseline in 48 hours, which is not consistent with serious, irreversible acute tubular necrosis, which may benefit from inpatient admission to monitor kidney function and the need for renal replacement therapy. In addition, she was hemodynamically stable and was able to tolerate an oral diet. When taking into account the patient's exam, imaging, and lab findings as well as her lack of need for diagnostic testing beyond what was done under observation care and the availability of any additional diagnostic testing as an outpatient, she had no requirements for inpatient level of care. Therefore, the requested health service was not medically necessary.
Diagnosis: Crohn's disease and celiac disease
Treatment: Rinvoq
The insurer denied Rinvoq
The health plan's determination is overturned. 

The patient is a female with Crohn's disease and celiac disease. She has failed 6-mercaptopurine, Remicade, Entyvio, and Stelara (started in 2018) every 4 weeks. While on Stelara every 4 weeks, she had improvement, but persistent rectal disease. She had improvement in rectal disease with the addition of Rinvoq.

Rinvoq is medically necessary for this patient.
The current medical literature supports the request for Rinvoq for the treatment of Crohn's disease. The patient's disease is severe and diagnosed at a young age, with history of multiple medication failures, including all primary therapeutic medication classes recommended by guidelines for the treatment of Crohn's disease. Several studies have assessed the use of multiple therapies concurrently, including biologic therapy (such as Stelara) with small molecule therapy (such as Rinvoq). In aggregate, no significant safety issues were attributed to combination therapy, and the therapy was broadly successful in improving response in patients who had failed biologic therapy. Rinvoq is Food and Drug Administration (FDA) -approved for the treatment of Crohn's disease, and has demonstrated safety and efficacy.