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

Diagnosis:  Dental Problems (skeletal Class II malocclusion, maxillary and mandibular crowding, retruded mandible, excessive overjet, maxillary incisor protrusion, buccal crossbite of maxillary premolars and blocked out mandibular second molars).
Treatment:  D8080 braces and treatment visits.

The insurer denied coverage for D8080 braces and treatment visits.  The denial is overturned. 

This patient is a male child, who presented for evaluation for orthodontic care.  The orthodontist identified skeletal Class II malocclusion, maxillary and mandibular crowding, retruded mandible, excessive overjet, maxillary incisor protrusion, buccal crossbite of maxillary premolars and blocked out mandibular second molars.  The orthodontist has completed the Handicapping Labio-Lingual Deviation (HLD) index, attaining 35 total points.  The insurer has denied coverage for orthodontic treatment as not medically necessary, stating that the clinical circumstance does not meet the required handicapping malocclusion medical necessity requirements. 

Upon review of the submitted documentation (study models were not provided for review) it is evident that the patient exhibits a significant malocclusion.  However, to assess for severity of the malocclusion and therefore medical/dental necessity for orthodontic care, the HLD index is utilized.  This index provides 6 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 35 points to justify orthodontic care.  This reviewer concurs with the HLD index completed by the orthodontist, attaining a total of 35 points on the HLD index (5 overjet, 5 overbite, 12 ectopic eruption, 10 anterior crowding, 3 labiolingual spread), which is above the threshold of 26 points to support orthodontic care for this patient.

D8080 braces and treatment visits are considered medically necessary for this patient.

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

Based on the above, the medical necessity for D8080 braces and treatment visits is substantiated.  The insurer's denial should be overturned.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Coronary Heart Disease, COPD, Anxiety and
Depression
Treatment: Personal Care Aide Level 2: 12 hours per day - 7 days per week; 12 hours per day - 7 days per week for a total of 168 hours per week
The insurer denied the Personal Care Aide Level 2: 12 hours per day - 7 days per week; 12 hours per day - 7 days per week for a total of 168 hours per week.
The denial is upheld. 

The patient is a female with a history of Coronary Heart Disease, COPD (chronic obstructive pulmonary disease), Anxiety and Depression. Due to impairments related to these conditions, she requires assistance for completion of the majority of her activities of daily living (ADLs). An appeal review was requested for potential approval of 168 hours/week Personal Assistance Services to offer increased ADL (activities of daily living) support.

No, the Personal Care Aide Level 2: 12 hours per day - 7 days per week; 12 hours per day - 7 days per week for a total of 168 hours per week is not deemed medically necessary. 

This is a female with a history of Coronary Heart Disease, COPD (chronic obstructive pulmonary disease), Anxiety and Depression. Due to impairments related to these conditions, she requires assistance for completion of the majority of her activities of daily living (ADLs). However, an assessment of the patient's functionality and ability to perform ADLs (activities of daily living) was completed and revealed that the currently approved plan of 56 hours/week Personal Assistance Services is sufficient to meet the patient's current needs. There is no additional documentation which demonstrates that the patient has sustained further functional loss since the date of this last assessment. For these reasons, the proposed treatment 168 hours/week Personal Assistance Services is not deemed medically necessary.
Appeal type: Step Therapy
Decision: Overturned

Diagnosis:  Plaque Psoriasis.
Treatment:  Skyrizi.

The insurer denied the Skyrizi.  The denial is overturned. 

The patient is a female with psoriasis affecting the face and scalp for whom Skyrizi is requested.  She has tried and failed topical and injected steroids, topical vitamin D derivatives, and apremilast.

Yes, the proposed treatment with Skyrizi is medically necessary. 

SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.  As such, it is a medically appropriate choice for this patient's severe psoriasis (affecting the face and scalp).  It does not carry and increased risk of malignancy and has excellent efficacy data.

Risankizumab (Skyrizi; risankizumab-rzaa) is a humanized immunoglobulin (Ig) G1 monoclonal antibody that specifically targets the p19 subunit of interleukin (IL)-23, thereby inhibiting interleukin (IL)-23-dependent cell signaling.  Subcutaneous risankizumab is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy (in the European Union [EU]), those who are candidates for systemic therapy or phototherapy (in the USA) and those who have an inadequate response to conventional therapies (in Japan).  In pivotal phase III trials (UltIMMa-1, UltIMMa-2, IMMvent and IMMhance), risankizumab was more effective than placebo, ustekinumab and adalimumab with regard to the proportion of patients achieving greater than or equal to (>=) 90% improvement from baseline in Psoriasis Area and Severity Index score (PASI 90) and a static Physician's Global Assessment score of 0 or 1 at week 16, with these benefits maintained over the longer term.  In supportive head-to-head trials, risankizumab was also superior to secukinumab and fumaric acid esters in terms of Psoriasis Area and Severity Index (PASI 90) response rate.  In an ongoing open-label extension study (LIMMitless), risankizumab was associated with durable and improved efficacy after switching from ustekinumab or adalimumab, as well as durable maintenance of efficacy through greater than (>) 2.5 years of continuous exposure.  Treatment with risankizumab improved health-related quality of life and was generally well tolerated, both in the short- and longer-term. 

Methotrexate and acitretin carry a much higher risk of adverse events, while not offering an advantage in efficacy.  They should also not be used by a woman of childbearing potential.  Cyclosporine is not an appropriate long-term solution due to the side effect profile and is used as a bridge or rescue treatment while another treatment's effect is waited upon to "kick in".  Biologics show superior results to conventional systemic therapies (70% improvement versus 40% improvement) for the treatment of patients with moderate to severe psoriasis.  Since the patient has lesions on the face, phototherapy is not a good choice, as the disease is obviously refractory to ultraviolet light, to which it is exposed daily.

Therefore, Skyrizi is medically appropriate and necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Recurrent panuveitis syndrome 
Treatment: Acthar gel
The insurer denied the Acthar gel.
The determination is upheld.

This is a patient with recurrent panuveitis syndrome unspecified who has been treated in the past with oral nonsteroidal anti-inflammatory drugs (NSAIDs), topical steroids, periocular steroids, oral steroids, Humira, methotrexate and Cellcept. The patient was referred to a new specialist who found 20/60 and 20/25 vision with intraocular pressure (IOP). The amount and location of intraocular inflammation is not included in the notes. Repository corticotropin (Acthar gel) was ordered for control of the uveitis. The health plan denied the Acthar gel as not medically necessary. At issue is whether the Acthar gel is medically necessary.

The Acthar gel is not medically necessary at this time. There is not an exam that demonstrates ongoing inflammation or a history detailing past therapeutic failures or intolerances. There are only case reports showing improvement in small numbers of patients with no case controls. In addition, the side effects of Acthar gel can be significant. Without demonstrated failure or intolerance to other therapies, it is not medically necessary.

There is no documentation submitted to support the need for Acthar gel at this time. In addition, there is no documentation of previous therapeutic failures.

Acthar gel has been used in case reports for refractory panuveuitis with some success in reducing patient's dependence on long term steroids. However, when the drug was initially approved by the Food and Drug Administration (FDA) in the 1950s, controlled clinical trials and evidence based data were not part of the approval process. Therefore, there is not a lot of data about adrenocorticotropic hormone (ACTH) gel in uveitis patients. The need for long term therapy also limits its use. The adverse effects of ACTH gel can be similar to systemic corticosteroids and include fluid retention, altered electrolyte balance, increase in blood glucose, systemic hypertension, mood changes, weight gain, Cushingnoid features, among others. In some clinics, it is reserved for patients who have demonstrated failure or intolerance to other medical therapies. In this patient's case, there is no exam detailing the failure of her current therapies, nor is there discussion of past therapeutic failures or intolerances.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Vaginal bleeding, anemia and dizziness on exertion. 
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The denial is upheld. 

The patient is a woman. She had a history of uterine fibroids, and atrial fibrillation and was taking Coumadin. She was referred to the emergency room by her primary care physician with complaints of vaginal bleeding, anemia and dizziness on exertion. 

On admission, the patient's vital signs were normal, and her physical examination was normal. The pelvic examination reported vaginal bleeding of unidentified amount. There was no pelvic examination performed. She denied syncope, chest pain, shortness of breath and palpitations. Her H/H (hemoglobin/hematocrit) was 6.6/20.8. Her EKG (electrocardiogram) was normal. PT (prothrombin time) and INR (international normalized ratio) were elevated. She was transfused one unit of packed RBC (red blood cells) and was admitted to the inpatient service where she was transfused with another unit. A repeat H/H (hemoglobin/hematocrit) was 8.3/25.6. An endometrial biopsy and pelvic ultrasound were performed. Her Coumadin was discontinued, and she was discharged.

No, the Inpatient admission was not medically necessary.

The medical records and medical literature were thoroughly reviewed. The patient was admitted to the emergency room with documented anemia and dysfunctional uterine bleeding. There is no documentation of a pelvic examination during the entire admission, and therefore no objective quantitative assessment of the patient's bleeding. Therefore, the severity of the bleeding cannot be assessed in the documentation. All other documentation of the patient's bleeding was reported from the patient's history. Her vital signs were stable, with no evidence of hemodynamic instability, and there is no documentation that the bleeding was severe. The patient underwent two blood transfusions over the first admission day, and the hemoglobin stabilized. She had normal vital signs and was not significantly symptomatic from the anemia as confirmed by physician progress notes. She did not have significant co-morbidities to support inpatient admission. The patient was therefore stable and could have been transfused blood in an ambulatory setting within the facility, with observation, at the time and subsequent to emergency room admission. Transfer to an ambulatory unit or an intermediate patient observation unit would have been within the standard of care. Therefore, the inpatient admission was not medically necessary. The health plan act reasonably, with sound medical judgment and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Shortness of breath
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The denial is upheld. 

The patient is a female with past medical history of drug abuse and psych disorder. She presented to emergency room with shortness of breath. 

The patient was found to be hemodynamically unstable with moderate respiratory distress. The patient was treated with oxygen, beta blockers, nebulizations, and steroids without much improvement. The CT (computerized tomography)-chest showed probable pulmonary embolism, and the patient was started on Lovenox. 

Due to hemodynamic instability, the patient was admitted to acute hospitalization. The patient remained tachycardic, but her shortness of breath had improved. The patient's oxygen levels were above 90% on room air. The patient was ambulating, and she was tolerating oral diet. The patient left against medical advice the following day.

No, the Inpatient admission was not medically necessary.

The acute hospitalization from was not medically necessary. The patient's SOB (shortness of breath) improved with emergency room care. The patient's oxygenation improved with IV (intravenous) steroids and supplemental oxygen. A lower level of care, such as observation level of care, would have been as safe and effective as acute in-hospital level of care in this patient.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Hidradenitis Suppurativa.
Treatment: Pharmacy/Prescription Drug (Otezla).

The health plan denied the requested prescription drug (Otezla).  The health plan's determination is overturned.

This patient is a woman with a several year history of severe hidradenitis suppurativa.  She has undergone multiple treatments including five surgeries (axilla, inguinal, buttocks), Adalimumab, Doxycycline, Prednisone, Spironolactone, Infliximab (with which she had anaphylaxis-type reaction), Metformin, and intralesional Kenalog.  Per the most recent clinic note she had worsened lesions in the axillae and inguinal region while taking Humira 40 mg (milligrams) weekly, Doxycycline 200 mg nightly, Spironolactone, and Metformin extended release (XR) 500 mg daily.  The patient has had partial improvement with her current treatments but continues to have significant symptoms, and thus the patient's dermatologist would like to add Apremilast.

The health plan's determination is overturned, in whole.

The proposed treatment of adding Apremilast is likely to be more beneficial than standard treatment for this patient.  This patient has undergone multiple therapies that are on the more aggressive end of standard treatments for hidradenitis suppurativa, including multiple surgeries, Adalimumab, Infliximab, Metformin, Spironolactone, and oral antibiotics.  At the current time, Apremilast would be best classified as an experimental therapy.  However, there is evidence to suggest potential benefit.  To date in the literature, there has been one randomized control study (n=20)[1], one uncontrolled open-label study (n=20)[2], one case series (n=9)[3], and two case reports (n=2)[4] examining the effect of Aprelimast in hidradenitis suppurativa.  The overall conclusion of these studies and reports is that there was improvement in patients receiving Apremilast with moderate to severe hidradenitis.  This benefit included patients who were resistant or not fully responsive to standard treatments including Adalimumab, as this patient has been noted to be.  In the randomized controlled trial with n=20, more than half of patients (8 out of 15) who received Apremilast had significantly decreased abscess and nodule count and improved pain when compared to the control group [1].

I would recommend supporting at least a 4-6-month trial of Apremilast.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Hidradenitis Suppurativa.
Treatment: Pharmacy/Prescription Drug (Otezla).

The health plan denied the requested prescription drug (Otezla).  The health plan's determination is overturned.

This is the case of a woman with severe hidradenitis suppurativa, which her physician is requesting be treated with Apremilast (Otezla).  The patient has had the disease since 2011.  Her disease has not been adequately controlled, despite treatment with Doxycycline, Adalimumab, Prednisone, Spironolactone, and Metformin.  A trial of Infliximab resulted in anaphylaxis.  She has had multiple surgeries to areas of involvement in axillae, groin and buttocks.

The health plan's determination is overturned, in whole.

Yes.  This patient's disease has proved to be recalcitrant to the standard medical therapies.  Aggressive surgical intervention has also been tried without adequate relief.  Appropriately, her physician has attempted control with newer agents, which have either failed to provide sufficient benefit (Adalimumab) or caused severe allergic reactions (Infliximab).  Reaching out for other options, her physician has requested a trial of Apremilast (Otezla).  There is a paucity of clinical studies/ trials with this new agent, but the few available offer promise.  Hence, it is a reasonable next step in therapy.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Hidradenitis Suppurativa.
Treatment:  Pharmacy/Prescription Drug (Otezla).

The health plan denied the requested prescription drug (Otezla).  The health plan's determination is upheld.

The patient is a female with hidradenitis suppurativa of the right axilla, groin, and buttocks, and with only a partial response to Humira.  The patient has undergone multiple surgeries and has been using Doxycycline off and on for years.  Inflectra was stopped because of side effects such as hypotension, headaches, and nausea.  The medical necessity of Otezla added to Humira for concurrent use is under review.

The health plan's determination is upheld, in whole.

No.  The use of Otezla in moderate (but not severe) hidradenitis suppurativa is supported by multiple open-label and Phase 2 studies, but Phase 3 studies and orphan drug status with the Food and Drug Administration (FDA) has not been pursued.  Furthermore, Otezla does not have any proven use in very severe cases of hidradenitis suppurativa, such as that of this patient's particular clinical scenario.  Only Humira [4,5] has been proven to be of benefit for the treatment of severe hidradenitis suppurativa at this time.  The concurrent use of Otezla with Humira has not been proven to be of any greater efficacy, and with confirmed safety, than use of Humira alone.

Long-term use of concurrent Doxycycline, hormonal therapies, and Humira are all indicated for this patient.  It is noted that this patient failed to tolerate Infliximab, which is a medically appropriate alternative treatment that unfortunately was not tolerated by this patient.  All other unproven treatments, including Otezla use with Humira, are all best and appropriately used in the investigational setting, with greater monitoring for both safety and efficacy.

Accordingly, the use of Otezla for this patient's particular scenario is not proven to be likely or beneficial for this patient's health and is, therefore, recommended to be denied for coverage.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Osteoarthritis, weakness, right hip replacement, Alzheimer's disease, dementia, rheumatoid arthritis, and hypertension
Treatment: Home Care/Personal Care HHC- Level 2 Personal Care Services per 15 minutes increase to 24 hours per day (live in)
The insurer denied the Home Care/Personal Care HHC- Level 2 Personal Care Services per 15 minutes increase to 24 hours per day (live in).
The denial is upheld. 

This patient is a female. The patient has diagnoses including osteoarthritis, weakness, right hip replacement, Alzheimer's disease, dementia, rheumatoid arthritis, and hypertension.  The patient is requesting increase from 56 hours per week to live-in Level 2 personal care services.  Assessment showed no changes from prior assessment in physical functioning, bathing, personal hygiene, dressing, walking, eating, meal prep, housework and medication management.  The patient functions with limited assistance - she is independent, and she uses assistive device for locomotion.  

No, the Home Care/Personal Care HHC- Level 2 Personal Care Services per 15 minutes increase to 24 hours per day (live in) is not medically necessary.

Live-in 24-hour personal care workers provide one-on-one care for individuals with stable chronic conditions that need daily assistance with ADLs (activities of daily living), including toileting, walking, transfers, turning/positioning, or feeding.  Personal care service is necessary when assistance cannot be met from use of from informal caregivers, by formal services, or by adaptive or specialized equipment or supplies.  Level 2 personal care service is indicated for individuals that need assistance with housekeeping, cleaning, meal preparation, grocery shopping, and laundry as well as assistance with personal needs, including bathing, dressing, grooming, toileting, walking, feeding, assisting with administering medications, preparing meals with special diets, and routine skin care. 

The assessment does not support the medical necessity for live-in Personal Assistance Service.  The patient is able to perform as independent to limited assistance.  This patient's level of functioning does not require live-in personal care services. The approved 56 hours per week is sufficient to provide assistance with ADLs (activities of daily living) and personal care for this patient's scenario.  Withholding the requested live-in services is not reasonably expected to affect the patient's health adversely.