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

Diagnosis: Major depressive disorder
Treatment: Transcranial magnetic stimulation (TMS)
The insurer denied coverage for TMS.
The denial is upheld.

This patient reportedly had depressive symptoms and major depressive disorder and had tried multiple past medications for depression with lack of efficacy including Prozac, Zoloft, Lexapro, Viibryd, Cymbalta, and Wellbutrin, and tried augmenters Rexulti, Abilify, Lithium, Lamictal, and Latuda. She reportedly had difficult functioning in school and interpersonally. The request was for transcranial magnetic stimulation (TMS) therapy.
  
The insurer denied coverage for TMS therapy for her, stating that she was under the age of 18 and that TMS therapy is FDA (food and drug administration) approved for major depressive disorder 18 years of age or older. 
  
The reviewer agrees with the decision to deny coverage for TMS therapy as there is not sufficient evidence in the medical literature to support its efficacy and long-term safety in patients under 18 years of age. The FDA approved Neurostar TMS Therapy for the treatment of depression in October 2008 in patients 18 years old and older and TMS therapy was cleared by the FDA in October 2008 and indicated for the treatment of major depressive disorder in patients who failed or who did not have satisfactory improvement from 1 past antidepressant medication at or above minimal effective dose and duration in the current episode. However, there is not sufficient evidence in the medical literature to support the efficacy and long-term safety for patients 18 years old and younger. According to Biology Psychiatry, NY (New York) May 2018, "Open Trial of Repetitive Transcranial Magnetic Stimulation in Youth with Treatment-Resistant Major Depression" by MacMaster FP, Croarkin PE, and Wilkes TC it states that a single center open trial suggest TMS is safe and effective in youth with treatment resistant major depression, but larger randomized controlled trials are needed. Also, according to the Journal of Child Adolescent Psychopharmacology 2016 26 (7) 5820589, "Magnetic Resonance Imaging Guided Open Label High Frequency Repetitive Transcranial Magnetic Stimulation for Adolescents with Major Depressive Disorder" by Croarkin PE, Marony-Smith MJ it states that TMS therapy is feasible, tolerable, and effective in adolescents with treatment resistant major depressive disorder but larger blinded sham controlled trials are needed for definitive safety and efficacy. It states that further efforts to understand optimal delivery, dosing, and biomarker development for repetitive TMS therapy treatment for adolescent depression is warranted. As a result, the recommendation is to uphold the previous decision and deny coverage for TMS therapy.

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

The insurer's denial of coverage for the for TMS is upheld. Medical necessity is not substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Alopecia Areata. 
Treatment: Xeljanz 10 milligram (mg) tablet, 60 tablets, 30 day supply by mouth. 
The insurer denied coverage for Xeljanz 10 milligram (mg) tablet, 60 tablets, 30 day supply by mouth. 
The denial is upheld. 

The patient is a young adult with a history of alopecia universalis as well as atopic dermatitis and Crohn's disease. The patient noted symptoms approximately one year ago and the symptoms were perhaps related to a post-COVID (coronavirus) phenomenon based on the documentation. The alopecia has progressed to the stage of alopecia universalis classification. The requested medication is Xeljanz 10 milligrams (mg) two times a day (BID). 

The scientific literature supports an improvement in alopecia areata and affiliated conditions (alopecia totalis and alopecia universalis) with systemic janus kinase (JAK) inhibitors. The documentation provided does not show that the patient has tried/failed or has a contraindication to any topical or systemic therapeutic options. 

Xeljanz does not currently have Food and Drug Administration (FDA)-approval for alopecia areata. In contrast, Baracitinib is an FDA approved janus kinase-signal transducer and activator (JAK-STAT) inhibitor that is approved for the treatment of alopecia areata. 

Systemic JAK inhibitors can have side effects and require laboratory testing to determine whether the patient is a good candidate for systemic treatment. The documentation provided does not provide the necessary information to approve non-FDA approved Xeljanz over alternative therapies for the treatment of alopecia universalis, including but not limited to Baracitinib. 

Based on the documentation provided, Xeljanz is likely not the best available therapy for this patient at this time, and the adverse risks may be increased over standard treatment/services. 

Xeljanz is not likely to be more beneficial than any other standard treatments. The carrier's denial of Xeljanz 10 milligram (mg) tablet, 60 tablets, 30-day supply by mouth should be upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate cancer
Treatment: OncotypeDx testing
The insurer denied the OncotypeDx testing.
The health plan's determination is upheld. 

The patient is a man. He recently was found to have Gleason grade group 2 prostate cancer. Pre-treatment prostate-specific antigen (PSA) was 13.7. OncotypeDx testing was ordered to assist in therapeutic decision making.

The Oncology Genetic Testing: OncotypeDx Genomic Prostate Score (GPS) Assay was not medically necessary for this patient.
The American Society of Clinical Oncology (ASCO) guidelines have stated, ""Tissue-based molecular biomarkers (evaluating the sample with the highest volume of the highest Gleason pattern) may improve risk stratification when added to standard clinical parameters, but the Expert Panel endorses their use only in situations in which the assay results, when considered as a whole with routine clinical factors, are likely to affect a clinical decision. These assays are not recommended for routine use as they have not been prospectively tested or shown to improve long-term outcomes-for example, quality of life, need for treatment, or survival."
Current guidelines of the National Comprehensive Cancer Network (NCCN) do not endorse the use of this test for this patient's medical problem. It is one of several biomarkers that have not been subjected to randomized controlled studies and have been marketed with significant industry influence.
This is consistent with the American Urological Association (AUA) guidelines as well, noting "Clinicians should not routinely use tissue-based genomic biomarkers for risk stratification or clinical decision-making. "
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Ears/Nose/Throat - Right eustachian tube dysfunction.
Treatment: Surgical Services (Eustachian tube balloon dilation)
The insurer denied Eustachian tube balloon dilation.
The denial is overturned. 

The patient is a female with right eustachian tube dysfunction. The patient complains of pressure and Valsalva maneuver does not help her symptoms. An exam revealed a retracted ear drum. Her hearing test was normal and type C tympanogram on right was noted. Medical management included nasal steroids and nasal antihistamines along with oral steroids. Balloon eustachian tube dilatation has been recommended.
At issue is the medical necessity of Eustachian tube balloon dilation.

The health plan's determination of medical necessity is overturned in whole.

Yes, the requested health service/treatment of Eustachian tube balloon dilation is medically necessary for this patient.
The patient has symptoms of eustachian tube dysfunction refractory to nasal and oral steroids with noted exam findings of a retracted ear drum and a negative pressure tympanogram and type C tympanogram that did not respond to medical therapy. Randomized studies have shown this procedure to be effective over 1-2 years post procedure. This procedure is United States Food and Drug Administration (FDA) approved and considered the standard of care treatment in the United States.  This is considered standard of care for patients with medical refractory eustachian tube dysfunction and has been shown in the peer reviewed literature to be an effective treatment.
Therefore, the requested health service/treatment of Eustachian tube balloon dilation is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ears/Nose/Throat/Tonsillitis - Coughing up blood
Treatment: Inpatient Hospital
The health plan denied the inpatient admission as not medically necessary.
The health plan's determination is upheld.

The patient is a female with a post-tonsillectomy bleed. She was transferred to the treating hospital from an outside hospital. The patient's vital signs were stable. There was no active bleeding. Ear, nose, and throat (ENT) service was consulted, and no surgical intervention was recommended. The patient was discharged.

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

The requested health service/treatment of Inpatient admission was not medically necessary for this patient. The patient had stable vital signs and laboratory values. She was not actively bleeding upon presentation. An ENT consult was done, and observational management was recommended. No surgical intervention was recommended. The patient had no significant or prolonged bleeding while in the hospital. For these reasons, this service did not require an inpatient level of care.
Therefore, the requested health service/treatment of Inpatient admission was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Substance Abuse/Addiction- Alcohol Abuse.
Treatment: Inpatient Hospital.
The insurer denied Inpatient Admission.
The denial is upheld.

The patient is a male with a past medical history of alcohol abuse, hypertension, bipolar disorder, and cardiomyopathy, who presented with reports of diaphoresis, nausea, and tremors. The review of the system was negative for additional clinical symptoms. The patient was afebrile (temperature of 36.7) in the emergency department (ED). He was described as having tremors and mild diaphoresis. His blood pressure was 149/96, pulse rate was 111, respiratory rate was 17, and oxygen saturation was 99% on room air. The physical examination was unremarkable for positive clinical findings.
The laboratory evaluation demonstrated sodium of 138. Potassium was 3.1, chloride of 94, carbon dioxide (CO2) of 28, blood urea nitrogen (BUN) of 5.9, creatinine of 0.79, glucose of 101, white blood cell count (WBC) of 7.5, hemoglobin (Hgb) of 16.1, hematocrit (Hct) of 47.1, and platelets of 419. The computed tomography (CT) scan of the pelvis showed a developing abscess/phlegmon of the right buttock skin with subcutaneous edema.
The patient was admitted for alcohol withdrawal. The patient was treated with thiamine, folic acid, and dextrose (D5) intravenous (IV) fluids. The patient was monitored on Clinical Institute Withdrawal Assessment (CIWA) protocol and treated with Ativan.
At issue is the medical necessity of Inpatient Admission.

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

No, the requested health service/treatment of Inpatient Admission was not medically necessary for this patient.
The patient was admitted for alcohol withdrawal. The documentation does not support the inpatient level of care since the patient was hemodynamically stable and had no evidence of instability or focal neurologic deficits. The Diagnostic and Statistical Manual of Mental Disorders defines alcohol withdrawal as 2 or more distinguishing symptoms which develop within several hours to days following a significant decrease in alcohol consumption after a prolonged period of heavy drinking. These symptoms include nausea or vomiting, autonomic hyperactivity, insomnia, increased anxiety and agitation, tremor, perceptual disturbances, and seizure. In this case, the patient had mild tachycardia, and tremors. An inpatient admission was not required for clinical monitoring, Ativan, and IV fluids.
Therefore, the requested health service/treatment for Inpatient Admission was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Severe obesity, hormonal issues, hyperandrogenism syndrome, hypothyroidism, and goiter

Treatment: Weight loss surgery and inpatient hospital stay

The insurer denied coverage for weight loss surgery and inpatient hospital stay

The denial is upheld

According to the documentation provided, this is a female with a history of severe obesity, hormonal issues, hyperandrogenism syndrome, hypothyroidism, and goiter. The patient's weight was 217.6 with a body mass index (BMI) of 34.1.

As per bariatric surgery office visit the patient presented with clinically severe obesity with multiple attempts at traditional non-surgical weight loss attempts. Her BMI was 33.8. He noted she has controlled diabetes mellitus and noted that she will need to undergo evaluation for sleep apnea as well as psychological testing and to start an exercise regimen. The patient was seen again where it was noted BMI was 30.9. He noted she was making satisfactory progress in the non-surgical weight loss program. The provider saw her again where she came to complete her presurgical requirements. He noted she has seen the nutritionist and is working on her diet as well exercising. The provider saw her again where it was noted she was working on her checklist and where he reviewed the different surgeries. The provider saw her again where her BMI was noted to 30.1 with a weight of 192.2 and height of 67 inches. The provider saw her again where her BMI was 31.2 with a weight of 199.2. He noted that she completed her presurgical requirements and is looking for a date of surgery.

In a preop visit note the patient was seen for preop evaluation and was noted to be medically optimized for surgery. Her BMI was noted to be 30.24.

This patient has a BMI that has been consistently less than 35 and does not have the comorbidities that would require her to have bariatric surgery. In fact, her hemoglobin A1C (HbA1c) was only 4.9. In addition, as late as the preop evaluation visit her BMI was 30.24. Given her BMI of 35 and less without any comorbidities as noted by Milliman Care Guideline (MCG) Health Inpatient and Surgical Care 26th Edition Gastric Restrictive Procedure, sleeve gastrectomy by laparoscopy ORG: S-516 (ISC), she does not meet the guidelines for bariatric surgery.

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

The insurer's denial of coverage for weight loss surgery and inpatient hospital stay is upheld. Medical Necessity is not substantiated.
Appeal type: Formulary Exception
Decision: Overturned in Part

Diagnosis: Elective oocyte cryopreservation. 
Treatment: Leuprolide, Ganirelix, Follistim, and Menopur. 

The insurer denied: Leuprolide, Ganirelix, Follistim, and Menopur. 
The denial is partially overturned. 

The patient is an adult female who consulted with a reproductive endocrinologist for elective oocyte cryopreservation (OC). The patient reports that she has an increased lifetime risk of breast cancer as the indication for oocyte cryopreservation. Injectable fertility medications Lupron, ganirelix, Menopur and Follistim have been prescribed. The Health Plan has denied coverage of the service due to the lack of meeting coverage criteria.

The health plan should cover the proposed Lupron, ganirelix, and Menopur.  However, the health plan should not cover the proposed Follistim. 

The medical records and medical literature were thoroughly reviewed. The American Society for Reproductive Medicine, in its Practice Committee Opinion, states: "In recent years, the use of OC has greatly expanded not only for women facing gonadotoxic treatments but also for other indications, such as delaying childbearing, as well as for the purpose of oocyte donation." Therefore the service of Lupron, ganirelix, and Menopur is within the standard of care. 

However, there is no evidence that Follistim is more effective for ovarian stimulation than the formulary medication Gonal-F and there has been no evidence presented in the medical records that it is or has been ineffective or has adverse effects for this patient. Therefore there is no support in the peer-reviewed literature or as standard of care that Follistim is medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriasis. 
Treatment: Ilumya.

The insurer denied Ilumya.  The denial is overturned. 

The patient is a male with psoriasis, treated with topical steroids, topical calcineurin inhibitors, Enbrel, Tremfya, and Cosentyx. The provider recommended Ilumya. The health plan requires use of preferred agents Humira and Siliq.

At issue is the medical necessity of Ilumya 100 milligrams (MG)/milliliter (ML) subcutaneous (SC) pre-filled syringe (SOSY).

The health plan's determination of medical necessity is overturned in whole.

Yes, the requested health service/treatment of Ilumya 100MG/ML SC SOSY is medically necessary for this patient.

Ilumya is an approved, appropriate, and effective medication for psoriasis. A number of biologic agents are available for the treatment of moderate-to-severe plaque psoriasis. Currently, the selection of the first biologic, and the choice of sequential biologics in the event of efficacy/tolerability concerns, is made using a limited evidence base. It is generally considered medically necessary to continue a patient on a therapy to which they have favorably responded.

Therefore, the requested health service/treatment of Ilumya 100MG/ML SC SOSY is medically necessary for this patient.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Alopecia areata.
Treatment: Olumiant.
The health plan denied the requested medication Olumiant.  The health plan's determination is upheld.

The patient is a female with a diagnosis of severe and longstanding alopecia areata. The condition is reported to have worsened after catching COVID-19 twice. The patient has tried and failed oral steroids, Hydroxychloroquine, and topical Rogaine. However, the diagnoses of systemic lupus erythematous and androgenetic alopecia are also noted prominently in the clinic note, which also reports that the patient's alopecia is likely related to her lupus and past COVID-19 infection. The patient's Plaquenil (Hydroxychloroquine) use is for her lupus and is being managed by her rheumatologist.

At issue is whether Olumiant is more effective than the formulary drug. 

The health plan determination of Olumiant is recommended to be upheld.

There are no formulary alternatives that are proven to work in treating the diagnosis of alopecia areata. The health plan policy for Olumiant (covering this medication only for rheumatoid arthritis) does not apply to this patient's clinical scenario to possibly allow coverage of Olumiant for this patient's condition [1]. However, only the option of the Janus Kinase (JAK) inhibitor Olumiant (Baricitinib), recently approved by the Food and Drug Administration (FDA) for moderate to severe alopecia areata, has sufficient documentation of safety, efficacy, and favorable outcomes in the treatment of this condition.

Most of the literature and evidence to date [2-6] has focused on the JAK inhibitor Xeljanz (Tofacitinib), and unmet needs, coverage issues, and safety/outcomes questions remain unresolved and unanswered for Xeljanz in the treatment of alopecia areata. At this time, regardless of the patient's current health plan policy covering Olumiant only for rheumatoid arthritis, health plans will need to decide how to proceed with this new FDA-approved indication of alopecia areata for Olumiant.

Were this patient definitively diagnosed with alopecia areata of a severe extent, then current medical literature would support treatment of this patient's condition with Olumiant with respect to potential efficacy for a condition which currently has no reliable oral/systemic treatments. However, the patient's history of androgenetic alopecia (AGA), systemic lupus erythematosus, (SLE), and COVID-19-related hair loss raises significant issues of the role of alopecia areata in this patient's hair loss. Olumiant has not been sufficiently evaluated for the treatment of SLE (for which diffuse hair loss is not an uncommon symptom) or COVID-19-related alopecia, and until questions of causation and diagnosis of this patient's hair loss, the issue of whether or not to approve this requested Olumiant has been made moot.

Accordingly, it cannot be determined that the requested Olumiant would be effective for this patient, regardless of the lack of any formulary alternatives for this patient's condition.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Skin Disorders - Atopic dermatitis. 
Treatment: Pharmacy/Prescription Drugs - Opzelura 1.5% Ex cream. 

The insurer denied Opzelura 1.5% Ex cream. 
The denial is overturned. 

The patient is a male with atopic dermatitis, treated with numerous therapies including topical steroids (triamcinolone, clobetasol, halobetasol, and hydrocortisone), topical Tacrolimus, antihistamines and Dupixent. His provider has recommended Opzelura cream. The health plan requires the use of Eucrisa. 

At issue is the medical necessity of Opzelura 1.5 percent (%) external (Ex) cream. 

The health plan's determination of medical necessity is overturned in whole. 

The requested health service/treatment of Opzelura 1.5% Ex cream is medically necessary for this patient. 

Opzelura is now United States Food and Drug Administration (FDA) approved for atopic dermatitis, and this patient has tried and failed both topical steroids and topical calcineurin inhibitors. Eucrisa is more commonly used in mild atopic dermatitis. In the article by Papp et al, significantly more patients achieved Investigator's Global Assessment treatment success with 0.75% Opzelura (RUX) cream (50.0%/39.0%) and 1.5% RUX cream (53.8%/51.3%) at week 8. Significant itch reductions were reported within 12 hours of first application of 1.5% RUX cream. Application site reactions were infrequent (less than [< ]1%) and lower with RUX. 

Therefore, the requested health service/treatment of Opzelura 1.5% Ex cream is medically necessary.