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

Diagnosis:  Plaque Psoriasis.
Treatment:  Cosentyx Pen (2 pens) 150MG/ML (milligrams per milliliter) Pen Injector.

The insurer denied Cosentyx Pen (2 pens) 150MG/ML (milligrams per milliliter) Pen Injector.  The denial is upheld.

The patient is an adult male with a history of psoriasis. He has been on Cosentyx since 2019. The request is for approval for continuation of treatment.

The requested Cosentyx is not medically necessary.

The patient's health plan prefers prior treatment with three of the following: Humira, Stelara, Tremfya, Skyrizi, Taltz, and Otezla. Tremfya, Skyrizi, and Taltz have demonstrated significant efficacy, achieving Psoriasis Area Severity Index (PASI) 75 scores of 80-89% (percent), and Humira and Stelara achieved a PASI (Psoriasis Area Severity Index) 75 score of about 67% in clinical studies. There is no supporting documentation that the patient has any contraindications to these biologics. Namely, the patient does not have a history of severe active infections, untreated active or latent tuberculosis, moderate to severe congestive heart failure, or multiple sclerosis.

Otezla is FDA (United States Food and Drug Administration)-approved for the treatment of psoriasis. 30 mg (milligrams) twice daily reduced the severity of moderate to severe plaque psoriasis in the phase 3 ESTEEM trials, as well as improving difficult-to-treat nail, scalp and palmoplantar psoriasis. Most patient-reported outcomes, including pruritus and the total Dermatology Life Quality Index, also improved to a significantly greater extent with Otezla than with placebo, with significant improvements in pruritus and skin discomfort/pain visual analogue scale scores seen as early as week 2 with Otezla.

Therefore, both the formulary biologics, as well as Otezla, would be appropriate and effective treatment options for this patient.

The patient also does not have any contraindications to phototherapy, such as any photosensitizing disease or history of melanoma.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Asthma

Treatment: Formulary Exception for Ventolin HFA (albuterol)

The insurer denied coverage for Formulary Exception for Ventolin HFA (albuterol)

The denial is upheld

This is an adult patient who uses a beta 2 agonist Ventolin hydrofluoroalkanes (HFA) (Albuterol) for treatment of asthma. The patient is currently using the brand name Ventolin for the generic compound Albuterol.

The patient's insurance company has denied the use of Ventolin as there are other biologic equivalents of the drug Albuterol which are in the formulary of the insurance company and are the preferred drugs. The other equivalent medications are Proair and Generic Albuterol Sulfate. As per the patient's physician, the patient has an allergy to Proair. Further details were not provided. The formulary drugs are not expected to cause adverse effects. The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication. The formulary drug is not expected to be ineffective. The nonformulary drug is not expected to be more effective than the formulary alternatives. This patient can be treated with generic Albuterol Sulfate instead of Ventolin. These 2 drugs are biologic equivalents and the same compound.

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 Formulary Exception for Ventolin HFA (albuterol) is not substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Seizures. 
Treatment: Lamictal XR (extended release) 200 mg (milligram) tablet. 

The insurer denied coverage for Lamictal XR 200 mg tablet. 

The denial is overturned. 
 
This case involves an adult with a request for medication management. Pathology reported  spongiotic dermatitis from the right mid back as well as perivascular and interstitial dermatitis with mild spongiosis from the left neck. A determination letter reported the request for Lamictal was denied as there was no indication that the patient could not utilize formulary alternatives.  The letter stated the patient had been under the provider's care for many years for seizures.  Since then, the patient's seizures have been controlled with Lamictal and Keppra. It was reported that the patient developed a body rash when trying generic versions of the medications and a skin biopsy confirmed allergic reaction to the generic versions. The patient was recommended for ongoing use with brand names. 

In this case, formulary exception is supported. The generic version of the medication is non formulary. It is documented that prior attempts of utilization of the generic version resulted in a body rash. This response is confirmed by a pathology report. The patient has been stable on the current medication regimen for many years. Therefore, switching to another medication would not be advised. The formulary drug(s) is likely to cause the patient an adverse reaction. The formulary drug(s) has been ineffective based on the patient's clinical history with side effects. The requested drug would be more effective than the formulary drug given the history with side effects. As such, there is a formulary exception for the use of Lamictal XR 200 mg tablet. 

The formulary drugs are expected to cause adverse effects. The formulary drugs were tried, and the patient did have an adverse reaction or contraindication. The formulary drug is expected to be ineffective. The non-formulary drug is expected to be more effective that the formulary alternatives. 

The carrier's denial of the Request for Formulary Exception for Lamictal XR 200 mg tablet to treat seizures is overturned.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Seizures

Treatment: Keppra XR (extended release) 500 mg (milligrams) Tablet

The insurer denied coverage for Keppra XR 500 mg Tablet

The denial is overturned
 

This case involves an adult with a request for medication management. The pathology report noted spongiotic dermatitis from the right mid back as well as perivascular and interstitial dermatitis with mild spongiosis from the left neck. A determination letter reported the request for Keppra was denied as there is no indication that the patient could not utilize formulary alternatives. The letter stated the patient has been under the provider's care for many years for seizures. Since then, the patient seizures have been controlled with Lamictal and Keppra. It was reported that the patient developed a body rash when trying generic versions of the medications and a skin biopsy confirmed an allergic reaction to the generic versions. The patient was recommended for ongoing use with brand names.

In this case, the formulary exception is supported. The generic version of the medication is non formulary. It is documented that prior attempts of utilization of the generic version resulted in a body rash. This response is confirmed by a pathology report. The patient has been stable on a current medication regimen for many years. Therefore, switching to another medication would not be advised. The formulary drug(s) is likely to cause the patient an adverse reaction. The formulary drug(s) has been ineffective based on the patient's clinical history with a side effect. The requested drug would be more effective than the formulary drug given the history with a side effect. As such, there is a formulary exception for the use of Keppra XR 500 mg Tablet.

The formulary drugs are expected to cause adverse effects. The formulary drugs were tried, and the patient did have an adverse reaction or contraindication. The formulary drug is expected to be ineffective. The non formulary drug is expected to be more effective that the formulary alternatives.

The carrier's denial of the Request for a Formulary Exception for Keppra XR 500 mg Tablet is overturned.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: schizophrenia and epilepsy

Treatment: Continued long term care placement

The insurer denied coverage for continued long term care placement

The denial is overturned

This is an adult with history of an immunocompromising condition, disseminated Mycobacterium-avium-intracellular (MAI), schizophrenia and epilepsy. The patient was hospitalized and subsequently transferred to a skilled nursing facility for subacute rehabilitation due to generalized weakness. The patient was also continued on intravenous (IV) antibiotics for sepsis treated at the hospital. Under review is the medical necessity for continued long term care placement.  

The patient's clinical condition and limited ability to perform activities of daily living and functional mobility, support continued long term care. The treating physician indicates "long-term skilled nursing services are essential for this patient's survival." The patient has chronic medical conditions, including immunocompromising viral infection, epilepsy and schizophrenia.  The patient continues to require assistance for activities of daily living, is bowel/bladder incontinent and non-ambulatory. It was noted that the patient was homeless and needed a structured environment to continue the treatment for the foot wound and help maintain compliance with medications for treatment of the patient's immunocompromised condition, epilepsy, and schizophrenia. Given the totality of the diagnoses, displacement from a home environment, and the need for a structured environment to continue medication administration and compliance with a plan of care, the continued long-term care placement would be appropriate. 

From a physical medicine and rehabilitation perspective, continued long term care placement is medically necessary.  

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 continued long term care placement is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Rheumatoid arthritis and systemic lupus erythematous (SLE).
Treatment: Pharmacy/Prescription Drugs: Rituximab-ABBS, biosimilar, 10 milligrams (mg), 200 units.
The insurer denied Pharmacy/Prescription Drugs: Rituximab-ABBS, biosimilar, 10 milligrams (mg), 200 units.
The determination is upheld.

This patient has a history of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) nephritis. They presented with joint pain for which they were treated with prednisone and plaquenil. They were diagnosed with lupus nephritis. They were given pulse solumedrol 250 milligrams (mg) times 3 days and started on Mycophenolate mofetil (MMF), later switched to myfortic. However, their renal and joint disease progressed, necessitating additional steroids. They also tried tacrolimus and benlysta without improvement. They were given truxima with significant improvement in both arthritis and renal function and her steroids were successfully tapered down to medrol 4 milligrams (mg) daily. At issue is the requested health service/treatment of injection, rituximab-ABBS, biosimilar, 10 milligrams (mg), 200 units.

Rituxan is used to treat lupus nephritis in refractory cases. A paper by Melander et. al. found that "rituximab is an interesting therapeutic option in relapsing or refractory lupus nephritis when early B cell depletion is obtained". Later, a paper by Diaz-Lagares et. al. concluded that, "rituximab is currently being used to treat refractory systemic autoimmune diseases. Rituximab may be an effective option for patients with lupus nephritis, especially those refractory to standard treatment or who experience a new flare after intensive immunosuppressive treatment".

There is not adequate efficacy or safety data to support every 3 month dosing. Moreover, there is insufficient data to demonstrate that the patient is flaring and requires re-treatment before the 6 month time period. According to UpToDate, for rheumatoid arthritis (RA), standard rituxan dosing is 1000 milligrams (mg) on day 1 and day 15 dosed 6 months apart; however, "rituximab can be administered as frequently as every four to six months depending on disease activity, but most patients are treated less frequently due to adequate disease control. Studies have demonstrated that a treat-to-target approach based on an increase in disease activity is more effective than physician preference to treat".
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alzheimer's Disease
Treatment: 168 Hours/Week, 12 Hours x 2 x 7 Days-Split Shift; Personal Care Aide-Level 2 
The insurer denied 168 Hours/Week, 12 Hours x 2 x 7 Days-Split Shift; Personal Care Aide-Level 2.
The denial is overturned.

The patient is a female with medical history notable for aphasia, advanced Alzheimer's dementia, bed-confinement, and incontinence of urine and feces. The patient is approved for 7 days per week of live-in personal care services. The patient and her care team requested an increased to 2-12 hour (split-shift) care, 7 days per week (168 hours per week). This request was denied by the insurance company, and this denial is the subject under review.

The health plan's determination is overturned. 

The requested health service/treatment of 168 Hours/Week, 12 Hours x 2 x 7 Days - Split Shift; Personal Care Aide-Level 2 is medically necessary for this patient. The patient has advanced dementia, is non-verbal and bed-bound, and is incontinent of urine and feces. She is currently approved for 24 hour live-in care. Live-in care aides should have a reasonable expectation of at least 5 hours of uninterrupted sleep per night. The patient has care needs that do not allow for this. She requires diaper changes and cleaning every 2-4 hours overnight. She is also unable to reposition herself in bed and requires repositioning every 2-3 hours. This demonstrates that it is medically necessary for her to receive continuous care. If she were left without care overnight, she would not have her toileting needs met and would be sitting in soiled diapers for a prolonged period of time. This could lead to skin breakdown and/or infection.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: alopecia areata
Treatment: Xeljanz
The insurer denied Xeljanz. 
The health plan's determination is upheld.

The patient is a female with alopecia areata, and with a history of rheumatoid arthritis. The patient has tried and failed topical, intralesional, and oral steroids for her alopecia areata. Prior to starting Xeljanz, the patient had lost all of the hair on her scalp and was severely depressed prior to starting Xeljanz.

Xeljanz is not medically necessary. Although the patient's psychological impacts from her alopecia areata is duly noted, the patient is being treated with a medication that has uncertain and insufficiently-studied dosage, safety, and outcomes data for long-term widespread use. The medication is not without its safety limits that argue against higher and long-term dosing, and treatment with Xeljanz for a condition (alopecia areata) with no significant functional impairment is neither medically appropriate nor necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Scoliosis
Treatment: Back surgery (22844, 20930, 22216, 22212, 22804 and 20936) x 1
The insurer denied back surgery (22844, 20930, 22216, 22212, 22804 and 20936) x 1.
The health plan's determination is overturned. 

The patient is a female with idiopathic scoliosis. She was initially seen by a chiropractor, and then subsequently by an orthopaedic surgeon. When seen by the orthopaedic surgeon, she was found to have a double major curve with both curves measuring above 70 degrees. The orthopaedic surgeon recommended surgery, consisting of a posterior spinal fusion with instrumentation. 

Back surgery is medically necessary for this patient. When the patient initially presented her curve already measured more than 60 degrees. Curves of this magnitude do not benefit from bracing, in the sense of altering the natural history of the disease, regardless of the level of skeletal maturity of the patient. At this time, the curves both measure more than 75 degrees, and the patient is 1.5 years postmenarcheal. Bracing is not effective in such patients and should not be considered. Surgical treatment of the scoliosis with instrumentation and fusion is necessary to prevent further progression.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Metastatic thyroid cancer; shortness of breath
Treatment: Continued Inpatient Hospital Admission
The insurer denied: Continued Inpatient Hospital Admission
The denial is upheld

The patient is an adult female with metastatic thyroid cancer with a BRAF mutation. She had prior chemotherapy and radiation and was placed on tafinlar plus mekinist last year. The patient was admitted to the hospital on 2 months later due to shortness of breath. She was placed on antibiotics and steroids initially. She was rhinovirus positive. She was given nebulizers every six hours.  

At this time the patient was noted to be hypertensive and hyperglycemic.  She was continued on nebulizers.  Her vital signs were stable with oxygen (O2) saturations in the 98 to 100 range.  The next day the patient felt dizzy.  She was continued on nebulizers and steroids.  Her blood pressure and blood sugar remained elevated. The following day the patient was discharged home to follow with her primary care provider (PCP).

The proposed continued inpatient admission was not medically necessary.

This patient was clinically stable for discharge.  Her vital signs were stable, and she was on oral steroids.  While the patient was hyperglycemic this is to be expected with high dose steroids and she was not in diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar non-ketotic coma (HONK) and her electrolytes were otherwise normal.  Uncomplicated hyperglycemia does not require ongoing acute level care.  While the patient's voice remained raspy, she was on nebulizers that could be continued as an outpatient as needed.  As stated above, the patient was breathing comfortably and was not hypoxic or hypercapnic.  She was tolerating oral steroids without issue. 
 
In addition, the patient's blood pressure remained poorly controlled due to underlying disease and steroids.   However, the patient was not in hypertensive urgency or emergency and there was no need to maintain acute level care for this issue.  Poorly controlled blood pressure is often dealt with on an outpatient basis.  

As this patient was clinically stable and could safely have been managed in a lower-level care setting, continued acute level care on the dates of service in question was not necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Class II Malocclusion and unilateral posterior crossbite on the right. 
Treatment:  Braces (Comprehensive Orthodontic Treatment) and Adjustments for Braces (Periodic Orthodontic Treatment). 

The insurer denied Braces (Comprehensive Orthodontic Treatment) and Adjustments for Braces (Periodic Orthodontic Treatment).  The denial is overturned.

The patient is a male with a Class II malocclusion and a unilateral posterior crossbite on the right. He has a mandibular deviation to the right. He had moderate crowding. He is treatment planned for orthodontics with rapid maxillary expansion to correct his crossbite, but the treatment was denied by the health plan on the basis that treatment is not medically necessary.

The health plan's determination is overturned.

There is strong medical evidence that that early correction of unilateral posterior crossbites with a shift reduces the need for future treatment. Research has shown that early intervention is beneficial for patients that have a crossbite with functional shift making, treatment at a younger age the preferable option. (1)  This patient presents with a posterior crossbite, crowding, and constricted arches. The requested orthodontic therapy can only be performed before the patient reaches skeletal maturity, otherwise the ability to achieve orthopedic expansion is greatly reduced.2 Therefore the requested treatment of braces (comprehensive orthodontic treatment) and adjustments for braces (periodic orthodontic treatment) is medically necessary at this time.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Plaque Psoriasis
Treatment: Cosentyx Pen
The insurer denied: Cosentyx Pen
The denial is: Upheld.

The patient is a female with moderate to severe plaque psoriasis affecting up to 60% (percent) body surface area who has failed therapy with multiple topical corticosteroids. The prescriber is requesting Cosentyx. The prescriber states that Cosentyx is preferred over the other therapies that are required to be used by the plan (i.e., Enbrel, Humira, Cimzia, Ilumya) due to lower risk of serious side effects. The subject under review is the medical necessity for Cosentyx Pen.

The health plan's determination is upheld.

The requested health service/treatment of Cosentyx Pen is not considered medically necessary for this patient. The patient has not had trial of an alternative biologic therapy with the plan's preferred agents Enbrel, Humira, Cimzia, and Ilumya. These biologic therapies are indicated for the treatment of this patient's plaque psoriasis at this time and their use follows current consensus guidelines for the use of biologic therapy in the treatment of plaque psoriasis. There is no documentation of a clinical contraindication to these therapies such as a prior hypersensitivity, active infection or history of chronic/recurrent infection, active malignancy or history of malignancy, congestive heart failure, demyelinating disease, immunosuppression, or residing in or traveling frequently to an area with endemic tuberculosis/mycoses. These therapies are indicated for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy, such as this patient who has failed topical therapy. It is reasonable to conclude that any of these therapies will provide an improvement of this patient's disease. Furthermore, Ilumya has similar rates of efficacy compared to Cosentyx; for example, the Clear trial showed Cosentyx achieving a psoriasis area and severity index (PASI)-90 of 73%, whereas the reSurface trials showed Ilumya achieving a PASI-90 of 68%. Therefore, due to the availability of other biologic therapies with superior efficacy compared to the patient's previously failed therapies and at least one alternative biologic therapy with similar rates of efficacy to Cosentyx, the request for Cosentyx is not considered medically necessary for this patient at this time.