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

Diagnosis: Alopecia
Treatment: Xeljanz 10mg (milligram) tablets
The health plan denied: Xeljanz 10mg (milligram) tablets
The determination is: Upheld 

The patient is a male with alopecia areata. He has tried and failed oral, topical, and intralesional steroids for over 6 months. He has been doing well on Xeljanz and has experienced regrowth over his entire head and body.

Xeljanz 10 mg (milligram) tablets, is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
There is no documentation that the patient has exhausted all topical options, and that it would therefore be medically necessary to continue systemic treatment which carries a higher side effect profile.
For example, there is no documentation provided that the patient has tried and failed topical immunotherapy, such as Diphenylcyclopropenone (DPCP). 

Chiang et al writes their 2015 study findings: that for DPCP "treatment success, defined as 50 percent (%) terminal hair regrowth, was reached in 71% of alopecia totalis patients and in 56% of alopecia universalis patients" 1. Moreover, there is no documentation that the patient has tried and failed topical minoxidil. A recent study reports that treatment of alopecia areata "with 5% minoxidil proved effective, and clinically and statistically safe" 2. Topical squaric acid dibutylester is a sensitizing agent which is also used for the treatment of alopecia areata, and has been shown to be effective in several studies 3. Based on the documentation provided, the patient has not tried and failed all topical therapies available. These topical medications, which have been shown to be effective for the patient's condition, should be tried and failed prior to initiating Xeljanz. Therefore, Xeljanz is not medically necessary for this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

Immunologic Disorders
Pharmacy/Prescription Drugs

Diagnosis: Alopecia
Treatment: Xeljanz 10mg (milligram) tablets
The health plan denied: Xeljanz 10mg (milligram) tablets
The determination is: Upheld 

The patient is a male with severe alopecia areata universalis that resulted in the loss of all his hair on the scalp, face, and body. This resulted in severe depression that affected every aspect of his life. After starting Xeljanz, the patient was able to maintain full hair regrowth and is currently at a dosage of 10 milligrams (mg) twice-daily.

Xeljanz 10 mg tablets is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
While understandable to consider Xeljanz (tofacitinib) for this patient's condition, the requested medication is investigational at this time, and merits further study before being presumed acceptable for widespread clinical use. At this time, the long-term safety of this medication is not confirmed, as is short-term efficacy in the use of Xeljanz for this condition.
Alopecia areata is notoriously difficult and unpredictable to treat, as well as unpredictable in its response to treatment. Oral immunosuppressants, light therapy, contact allergen treatment and related therapies have all resulted in variable and unsatisfactory outcomes, and self-resolution is often the only choice a patient has (along with hairpieces) for severe cases.
However, while Xeljanz has some promising preliminary results in open-label studies, 5, 6 the overall literature and reviews on alopecia areata 2-4 mention Xeljanz only as investigational. Xeljanz was denied Food and Drug Administration (FDA) approval for use in psoriasis, in large part for safety reasons, and is not without a significant risk of side effects that preclude an acceptable risk for use outside of the investigational setting for the condition of alopecia areata.

At this time, Xeljanz is only FDA-approved for juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and patients with rheumatoid arthritis who have failed Methotrexate.
Appeal type: Medical necessity
Decision: Overturned


Diagnosis: sacral decubitus ulcer
Treatment: home health care
The insurer denied Consumer Directed Personal Assistance Program (CDPAP) Services: Total Amount of 70 Hours per Week (10 Hours per Day / 7 Days 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, stage 4 sacral decubitus ulcer, and osteomyelitis. 

The requested Consumer Directed Personal Assistance Program (CDPAP) Services: Total Amount of 70 Hours per Week (10 Hours per Day / 7 Days per Week) is medically necessary for this patient.
The patient's personal care needs are extensive. He is not able to perform any activities of daily living without hands-on assistance. He is bed bound at this time. He also requires assistance with turning and repositioning. He has pressure ulcers on both the sacrum and the left ankle. His care needs are expected to be unscheduled and continuous throughout the day and night. The requested increase to 70 hours per week is reasonable in light of the patient's personal care needs. The requested increase is medically necessary for the patient.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Mental Health- Generalized Anxiety disorder.
Treatment: Pharmacy/Prescription Drugs/Lexapro
The health plan denied the prescription drug Lexapro as not meeting its formulary criteria. The reviewer has upheld in whole the health plan's determination.


This case involves an adult female diagnosed with generalized anxiety disorder and multiple other comorbid conditions. The patient is prescribed brand Lexapro after failing to tolerate the generic formulation. The patient has a history of intolerance to generic medications with failed trials of generic Wellbutrin, Cymbalta, Zoloft, and Lexapro. Current medications include brand Lexapro and Wellbutrin.
The health plan denied coverage of the brand Lexapro, as a generic medication or Trintellix is required under the plan with a requirement of three formulary trials and failure before a coverage exception is allowed under the plan. Formulary alternatives include escitalopram, citalopram, sertraline, paroxetine (immediate release (IR) or extended release (ER)), fluoxetine, and Trintellix.
In this case, the remaining formulary drugs have not been shown to be ineffective, and there is no evidence that the remaining formulary drugs would not be as effective as the non-formulary drug or would have adverse effects.
There is no evidence that the remaining generic formulations would be ineffective or would vary in the bioavailability or clinical effect for this patient. This assertion is consistent with the existing scientific literature, referenced below. Moreover, one formulary alternative includes a brand medication, Trintellix, which is covered under the plan, as well as citalopram, fluoxetine, and paroxetine. The health plan's determination is upheld.
This answer is consistent with the scientific literature and published guidelines, referenced below, as well as consistent with New York State instruction for this review pertaining to a formulary exception.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/ Gastrointestinal-Crohn's Disease
Treatment: Pharmacy/Prescription Drugs-Remicade
The health plan denied the treatment of Remicase as not medically necessary. The reviewer has overturned in whole the health plan's determination. 

The patient has Crohn's disease. He had been on Remicade, with a change to Inflectra (400 milligrams (mg) every 8 weeks). Per the notes he has had four Inflectra infusions, with onset of symptoms (abdominal pain and increased bowel movement frequency) 2-3 weeks before infusions. He had also had the same effect when switching from Remicade to Inflectra. The coverage is requested for Remicade for the treatment of Crohn's disease.

Yes, the use of Remicade is supported as medically necessary in this case. At issue in this case is a request for the use of Remicade instead of a biosimilar form of infliximab (Inflectra) in this patient with Crohn's disease. 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 lack of Crohn's disease control can result in significant adverse events such as disease flare, fistula, stricture, 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]. Although the Inflectra dose could be increased in this case in an attempt to regain response, infliximab is associated with risks such as drug-induced lupus, demyelinating disorders, lymphoma, infection, and melanoma, so a higher dose should be avoided if possible [9,10]. For these reasons, the request for Remicade is supported in this patient who was stabilized on Remicade and lost response on Inflectra.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crowding
Treatment: D8080 braces; D8670 monthly visit x (times) 12
The insurer denied D8080 braces; D8670 monthly visit x 12.
The denial is overturned.

This patient is an adolescent female. The denial of comprehensive orthodontic treatment of the adolescent dentition is being appealed. The patient was diagnosed as a skeletal Class I, with moderate maxillary and mandibular crowding. The initial review denied treatment due to lack of automatic qualifiers and a HLD (Handicapping Labio-Lingual Deviation) score of less than 26.

The D8080 braces; D8670 monthly visit x (times) 12 are medically necessary.

The patient in this case does have an anterior crossbite of the maxillary left lateral incisor and the mandibular left canine. There is evidenced to be attachment loss and thinning of the gingival tissue around tooth (number) #22. This does meet the criteria as an automatic qualifier. The request is therefore medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cerebrovascular accident (CVA) secondary to right MCA (middle cerebral artery) thrombosis with left hemiparesis
Treatment: Continued Stay in Subacute Rehabilitation Facility
The insurer denied: Continued Stay in Subacute Rehabilitation 
Facility
The denial is upheld.

The patient is an adult male with history of general debility and ambulatory difficulty status post right middle cerebral artery (MCA) cerebral vascular accident (CVA) 4 months ago status post cranioplasty that became complicated with meningitis requiring hardware removal and presented in acute hospital with fever, altered mental status and seizure. The patient was treated with antibiotics for meningitis and bacteremia. He also developed pneumonia and an upper extremity deep vein thrombosis (DVT). Relevant past medical history includes hypertension, hyperlipidemia, alcohol abuse, deep vein thrombosis, urinary tract infection (UTI), right middle cerebral artery cerebral vascular accident with left hemiplegia, right hemicraniectomy, pneumonia, etc.  Prior to admission the patient was living alone in a condominium; he was independent with activities of daily living and driving, all prior to the initial stroke and was cognitively intact. The patient was initially admitted to skilled nursing facility (SNF) and was readmitted three days later requiring dependence for most activities of daily living. As of three weeks post admission, the patient was dependent for toilet hygiene, toilet transfer, shower/bath, requiring moderate to maximum assistance for upper/lower body dressing, requiring supervision for oral hygiene, etc. He did not show tangible progress in rehabilitation.

The proposed treatment is not medically necessary. 

The continued stay in skilled nursing facility (SNF) is not medically appropriate at the moment because the patient has not shown tangible improvement in rehabilitation and there are no ongoing clinical issues that require clinical nursing care according to InterQual 2022 Level of Care (LOC) Subacute and Skilled Nursing Facility criteria.
The patient was initially admitted to skilled nursing facility and was readmitted three days later requiring dependence for most activities of daily living. As of three weeks post admission, the patient was dependent for toilet hygiene, toilet transfer, shower/bath, requiring moderate to maximum assistance for upper/lower body dressing, requiring supervision for oral hygiene, etc. He did not show tangible progress in rehabilitation.
Therefore, continued stay in skilled nursing facility is not medically appropriate at this time.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Acne vulgaris. 
Treatment: Arazlo (tazarotene). 
The insurer denied coverage for Arazlo (tazarotene). 
The denial is overturned. 
 
The patient has a diagnosis of acne vulgaris. The patient has failed therapy with spironolactone and topical adapalene, tretinoin, azelaic acid, Winlevi cream.  The request is for Arazlo topical. 
The insurer has denied coverage for Arazlo (tazarotene). In their Final Adverse Determination letter they write that plan approved criteria covers this drug when the patient has tried and had an inadequate treatment response or intolerance to the required number of formulary alternatives, or the patient has a documented clinical reason such as expected adverse reaction or contraindication that prevents the patient from trying the formulary alternatives, if complete and valid documentation is provided. Formulary alternatives are: Adapalene (except adapalene pads or adapalene solution), Benzoyl peroxide, Clindamycin gel, Clindamycin solution, Clindamycin-benzoyl peroxide (generic Acanya), Erythromycin solution, Erythromycinbenzoyl peroxide, Sulfacetamide lotion 10%, Tazarotene cream 0.1%, gel (generic Tazorac), Tretinoin, Tretinoin gel microsphere, Aklief, and Winlevi. Requirement: Trial and failure of all the formulary alternatives, but not more than three. 

The Clinical guidelines for the management of acne vulgaris recommends topical therapies such as adapalene and tazarotene (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 "Topical retinoids are vitamin A derivatives that are prescription agents with randomized, double-blind, placebo-controlled trials supporting their use(arazlo for acne treatment...Active agents are available: ... adapalene (0.1%, 0.3% cream, or 0.1% lotion), and tazarotene (0.05%, 0.1% cream, gel or foam)...." (1).  Topical therapies such as adapalene and tazarotene are listed as a first line treatments within the acne guidelines, and throughout the dermatology literature as an effective treatment for acne (1-3).  

As the insurer guideline for allowing the use of Arazlo indicates if the patient has tried and failed three formulary alternatives, the medication is allowed. As noted above the Formulary alternatives are: Adapalene (except adapalene pads or adapalene solution), Benzoyl peroxide, Clindamycin gel, Clindamycin solution, Clindamycin-benzoyl peroxide (generic Acanya), Erythromycin solution, Erythromycinbenzoyl peroxide, Sulfacetamide lotion 10%, Tazarotene cream 0.1%, gel (generic Tazorac), Tretinoin, Tretinoin gel microsphere, Aklief, and Winlevi.

The formulary drugs are not expected to cause adverse effects. However; the formulary drugs tried have been ineffective. The patient has failed therapy with spironolactone and topical adapalene, tretinoin, azelaic acid, Winlevi cream.  Therefore, The non-formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for Arazlo (tazarotene) to treat acne vulgaris is overturned.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Seizure
Treatment: Inpatient Hospital Stay
The insurer denied the Inpatient Hospital Stay.
The determination is upheld.

This is a female child who presented to the emergency department (ED) with a four-day history of phlegm, subjective fevers, and a new-onset seizure lasting less than 15 minutes. She was treated immediately with intramuscular (IM) Versed and lab results were obtained. She was treated with both Tylenol and Motrin as well as a fluid bolus. Her temperature improved and she woke up after about 30 minutes. The examination was significant for no apparent distress, moist mucous membranes, clear lungs, a benign abdomen, no rashes, and a non-focal neurologic exam. She was admitted for further management of simple febrile seizure. The admission orders included Versed as needed for prolonged seizure, anti-pyretics, IV (intravenous) fluids, and clear liquids as tolerated. She remained afebrile following admission, initially on intravenous (IV) fluids but able to tolerate an advancing diet for age. Because this was her first episode of a febrile seizure, no further work-up was ordered. At issue is the medical necessity of an inpatient stay.
Inpatient hospital admission was not medically necessary for this child.

This young child presented to the ED with a first-time febrile seizure considered simple (lasting less than 15 minutes, occurring only once in 24 hours) despite a 30 minute post-ictal period. While it was not unreasonable to monitor her in the hospital for observation, she was overall hemodynamically stable with no recurrent seizure activity, no evidence of impending sepsis or respiratory failure, no significant metabolic derangements. She did not require acute inpatient admission and could have been safely managed at lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Breast cancer. 
Treatment: Radiation therapy. 

The insurer denied coverage for radiation therapy. 

The denial is overturned. 
 
This is the case of a patient who underwent surgery for early stage left breast cancer. Patient was recommended adjuvant radiation therapy (RT). 

This is the standard of care. This is recommended by National Comprehensive Cancer Network (NCCN) guidelines. 

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 radiation therapy services is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic Kidney Failure/ESRD
Treatment: Outpatient procedure 
The health plan denied: Outpatient procedure 
The determination is: Overturned

The patient is a female with chronic kidney disease and renal artery stenosis who was evaluated for worsening kidney function. The patient has a complex past medical history including hypertension, abdominal aortic aneurysm status/post (s/p) aortobifemoral artery bypass and renal artery stenosis s/p right renal artery stenting. A renal ultrasound demonstrated right renal artery stenosis and atrophic left kidney. The patient has a nonfunctional left kidney. She was diagnosed with right renal artery stenosis with worsening kidney function and was offered an angiogram with possible intervention.
At issue is the medical necessity of the outpatient procedure.
The health plan's determination is overturned in whole.
The requested health service/treatment of outpatient procedure is medically necessary for this patient. The patient has chronic kidney disease and renal artery stenosis with worsening kidney function. The proposed treatment, angiogram with possible stenting, is medically necessary and is the standard of care for the treatment of renal artery stenosis.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Cancer. 
treatment: Posaconazole. 

The insurer denied Posaconazole. The health plan's determination is upheld. 

This is a male with a history of renal cell carcinoma and stage IE diffuse large B-cell lymphoma of his right testicle. He experienced recurrence of the lymphoma and ultimately underwent salvage therapy with RICE (Rituximab + Ifosfamide + Carboplatin + Etoposide) to be followed by CAR-T (Chimeric antigen receptor) with lis-cel. Posaconazole has been recommended and is under review. 

A formulary exception is not indicated in this case. In patients receiving CAR-T therapy, there is a paucity of evidence that primary prophylaxis with posaconazole is more effective than formula alternatives, Neither the National Comprehensive Cancer Network (NCCN) nor the authors of Up-To-Date recommend posaconazole in lieu of fluconazole or itraconazole. As noted by Haidar, et al, fungal infections are rare in this clinical scenario. The authors of Up-To-Date echo these sentiments - that this agent is not more effective or has fewer adverse effects than the formulary alternatives.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dental caries

Treatment: Onlay procedure on tooth #1

The insurer denied coverage for onlay procedure on tooth #1

The denial is upheld 

Upon review of the documentation provided which includes copies of undated periapical and panoramic radiographs, undated intraoral clinical image and insurer correspondence, it appears that this patient presented to the dentist for comprehensive care. The treating dentist recommended onlay for tooth #1. The insurer has denied these services stating the there is no clinical or radiographic evidence, such as traumatic injury or decay, provided to support the necessity of this services and therefore the services do not meet medical necessity criteria. Dr. Timothy Pfister is appealing on behalf of the patient.

The objective documentation provided for review is undated periapical and panoramic radiographs in addition to a solitary undated intraoral clinical photograph. It appears that there is no evidence of fracture or other pathology specifically affecting #1 based on the images provided for review. There does not appear to be any radiographic evidence of caries. There does not appear to be any structural or pathologic issue associated with the existing crown on #1. The clinical photo and radiographs do not substantiate the requested dental services as enumerated above. 

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 onlay procedure on tooth #1 services is not substantiated.