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

Diagnosis: Digestive System/Gastrointestinal/Crohn's Disease
Treatment: Pharmacy/Prescription Drugs/Stelara 90MG/ML SC SOSY
The health plan denied the requested increase in the dosage of the prescription medication Stelara as not medically necessary. 
The health plan's determination is overturned.

This is a review for the use of Stelara (Ustekinumab) to treat severe Crohn's disease (CD). This female patient has severe ileocolonic Crohn's disease and has had prior bowel surgery. She has previously tried and failed two anti-tumor necrosis factor (TNF) agents (Adalimumab and Infliximab). She was started on Stelara and did well initially on Stelara at standard dosing every 8 weeks, but recently lost response. She had evidence of active stricture formation on colonoscopy and therapeutic drug monitoring revealed low Ustekinumab levels. 
Hence, the attending provider is requesting the use of Stelara at the escalated dose of 90 milligrams (mg) SC (subcutaneous) every 4 weeks to treat this patient's severe Crohn's disease.

I overturn, in whole, the health plan's determination of medical necessity.

Yes, the requested health service/treatment of Stelara 90 milligrams/milliliter (mg/ml) SC is medically necessary for this patient. Dose escalation is the standard of care in patients with inflammatory bowel disease who are on a biological agent and not responding to standard dose of the medication.
Since this patient was not responding to standard dosing of Stelara, it is reasonable to increase the dose of Stelara to 90 mg every 4 weeks. Dose escalation in biologic therapy used in inflammatory bowel disease can be done either based on clinical symptoms or laboratory markers or endoscopic or radiological features with or without therapeutic drug monitoring. Dose escalation is done either by increasing the dose of the medication or shortening the interval between doses or sometimes a combination of both. There are only a finite number of biological agents used to treat inflammatory bowel disease and the standard of care is to optimize dose of the biological agent before switching to another agent. Therefore, it is medically necessary to use Stelara 90 mg SC every 4 weeks to treat this patient's severe Crohn's disease.

Ollech and colleagues showed that shortening the Ustekinumab 90 mg dose interval to 4 weeks for patients with CD who did not respond to doses every 8 weeks improved clinical and biological indices of disease activity. Patients who lose response to the standard dose of Ustekinumab might benefit from dose interval shortening, which was effective and safe. Meserve and colleagues showed that in real world settings, Ustekinumab dose escalation was effective in achieving response in patients with CD with inadequate response, or loss of response to standard dose induction and/or maintenance therapy.
Based on the clinical data provided, dose escalation of Stelara to 90mg SC every 4 weeks is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hip pain
Treatment: Inpatient admission
The insurer denied:  Inpatient admission
The denial is overturned

The patient is a young adolescent female with right hip pain. She had pain for two weeks. She was evaluated in ED (emergency department) and diagnosed with SCFE (slipped capital femoral epiphysis). She underwent pinning the next day and was discharged the day after surgery.

The patient's physical examination was significant for decreased motion and external rotated. She was admitted to hospital.

The inpatient admission was medically necessary.
The records show that the young girl had a complex diagnosis. She was found to have a displaced slipped capital femoral epiphysis to her right hip. The findings were consistent for "acute on chronic." The treatment required is semi-emergent, as additional displacement can occur, which can influence prognosis.

The patient's admission was required ,and urgent surgical management was performed.

Her physician performed an open reduction with pinning. The operative report showed an arthrotomy was completed with direct visualization of pathology. The reduction was completed with appropriate fixation. This surgery was completed the day after admission. The child would require a period of post-surgical assessment and monitoring. She would clearly not be ready for discharge on later that evening, as she had surgical incision to anterior hip, arthrotomy and pinning. She also had 100cc (cubic centimeters) blood loss. She would likely require parenteral analgesia. It would be prudent to reassess in the morning and determine if she would be ready for discharge.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriasis.
Treatment: Otezla 30MG (milligrams).
The insurer denied: Otezla 30MG (milligrams).
The denial is overturned.

The patient is an adult female with psoriasis, treated with topicals and phototherapy. Her provider is requesting Otezla. The health plan requires a trial and failure of systemic immunotherapy.

The requested Otezla is medically necessary.
Otezla (apremilast) is a phosphodiesterase inhibitor, and therefore its mechanism of action is different from injectable biologics. Apremilast works intracellularly to modulate pro-and anti-inflammatory mediators.

The ESTEEM trial (randomized, double-blind) documented a favorable response to apremilast over placebo at week 16. Side effects were generally mild and did not result in discontinuation. PASI75 (75% reduction in Psoriasis Area and Severity Index score) was seen in 33% of patients, and PSAI50 (50% reduction in Psoriasis Area and Severity Index score) in 60%. Efficacy has been demonstrated in psoriatic arthritis as well, and it was the first FDA (United States Food and Drug Administration)-approved for spondyloarthropathies.

However, there are no studies to date comparing the efficacy of Otezla to other systemic medications for psoriasis. It is an oral therapy and requires less medication monitoring (current data do not indicate a need for laboratory monitoring) and is not immunosuppressive. Otezla is now among the growing number of systemic therapies for psoriasis. Currently, there are no evidence-based medical guidelines indicating which therapy is best or delineating a step-wise approach to psoriasis. The Guidelines of care for the management of psoriasis state that each patient requires individual tailoring and a stepwise approach is not recommended. No evidence-based literature could be found to support the use of other therapies before Otezla.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's disease
Treatment is Stelara (ustekinumab)
The insurer denied coverage for Stelara (ustekinumab).
The denial is overturned.

The patient has a history of Crohn's disease complicated by fistulas and obstruction. She has had 13 abdominal surgeries. She has previously failed treatment with Entyvio, Humira, and steroids. While on Entyvio, she has continued to have active gastrointestinal symptoms with an elevated CRP (C-reactive protein) level. Her physician feels that giving another anti-TNF (tumor necrosis factor) agent would not be beneficial for her and is requesting ustekinumab.

The American College of Gastroenterology has published a Clinical Guideline: "Management of Crohn's Disease in Adults." The article addresses the management of moderate to severe Crohn's disease. It states that ustekinumab should be given for moderate to severe Crohn's patients who failed previous treatment including anti-TNF inhibitors. It also states that it can be given to patients who have had no previous exposure to anti-TNF inhibitors. This is a strong recommendation with a high level of evidence.

This patient has severe Crohn's disease and has failed biologic therapy with both Humira and Entyvio. The American College of Gastroenterology supports proceeding with ustekinumab in this case. There is no requirement to try another anti-TNF agent prior to giving ustekinumab. 

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 Stelara (ustekinumab) services is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Brain Cancer.
Treatment: Xpovio.

The insurer denied the Xpovio.  The denial is upheld.

The patient is a female with glioblastoma (GBM).  She had surgery and was then placed on Temodar plus radiotherapy (XRT).   The patient has progressed, and the attending physician has now requested selinexor.

No, the proposed Xpovio (selinexor) is not medically necessary.

The drug selinexor is not currently Food and Drug Administration (FDA) approved, compendia supported or supported by the National Comprehensive Cancer Network (NCCN) to treat glioblastoma.  A small single arm phase II trial is insufficient to support this therapy, especially when there are multiple other standard options available.  At this time selinexor is only supported to treat myeloma and large cell lymphoma.  While there were responses with selinexor in glioblastoma, the response rate was approximately ten percent, and the authors of this study did not conclude that selinexor would be a new therapeutic option for glioblastoma.

Yes, he health plan acted reasonably, with sound medical judgment and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: chest pain
Treatment; inpatient stay
The insurer denied the inpatient stay. 
The health plan's determination is upheld.

The patient is a woman with a past medical history of cyclical vomiting syndrome and tobacco use who presented to the emergency department for evaluation of chest pain. She stated that she woke up around 3 AM with chest discomfort which she described as a stabbing sensation on the left side of her chest which was pleuritic in nature. She took Tylenol and Tums without significant relief which prompted her to present to the emergency department for further evaluation.

The inpatient hospital admission was not medically necessary. This patient presented for evaluation of chest pain. She was hemodynamically stable and there was no evidence of an acute infection. Her CT (computed tomography) scan of the chest did not demonstrate evidence of pulmonary embolism or acute aortic syndromes. Furthermore, there was no evidence of acute coronary syndrome with serial troponins. There was also no evidence of myocarditis/pericarditis. Her echocardiogram demonstrated normal biventricular function without significant valvular abnormalities. Consequently, based on the provided documentation, there is insufficient clinical data to support medical necessity for inpatient level of care. A lower level of care would have been appropriate in this case.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Axillary hyperhidrosis

Treatment: Botox

The insurer denied coverage for Botox

The denial is upheld

The patient is a female with axillary hyperhidrosis.  The patient is currently on Drysol and Qbrexza.  The requested medication is Botox injection.  

There is no documentation provided that the patient has failed traditional therapies for hyperhidrosis which are known to improve the condition.  Treatment with commonly used systemic mediations are known to improve hyperhidrosis.  One such example is the conventional treatment oxybutynin, which has been shown to be effective for hyperhidrosis.  Wolosker et al writes in "A randomized placebo-controlled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis" that "Treatment of palmar and axillary hyperhidrosis with oxybutynin is a good initial alternative for treatment given that it presents good results and improves quality of life." (5)

The conventional agents are appropriate agents for the treatment of the patient's hyperhidrosis. Conventional therapies are not more likely to cause adverse reactions and the documentation provided does demonstrate a contraindication to use of these medications. The conventional medications should be tried and failed prior to initiating Botox.  After review of the documentation provided, there is no documentation provided that would justify the patient requiring treatment with Botox prior to the conventional alternatives such as oxybutynin.  

The insurer's denial of coverage for Formulary Exception for Botox is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Thrombocytosis.
Treatment: Ferumoxytol (Q0138, 96365 and related pharmacy).
The insurer denied: Ferumoxytol (Q0138, 96365 and related pharmacy).
The denial is upheld.

The patient in this case is an adult female who was found to have mild thrombocytosis. The platelet count was 441 last year, and a repeat complete blood count (CBC) showed a platelet count of 408 one month later. The patient's hemoglobin was normal.  Her iron studies were notable for a ferritin of 17.2. The patient was treated with Feraheme.

The proposed treatment was not medically necessary.

This patient was diagnosed with iron deficiency in the absence of anemia. She had a mild elevation in the platelet count without significant symptoms. While the patient was iron deficient, there was no need for intravenous iron treatment. She could have been safely and effectively treated with oral iron. There is no evidence that intravenous iron is either safer or more effective than oral iron for the repletion of iron deficiency in the absence of anemia. Therefore, treatment with Feraheme, an intravenous iron preparation, was not medically necessary in this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Dermatitis
Treatment: Adbry 150MG (Milligrams) per ML (Milliliter) SC (Subcutaneous) SOSY (solution prefilled syringe), pre-service
The insurer denied: Adbry 150MG (Milligrams) per ML (Milliliter) SC (Subcutaneous) SOSY (solution prefilled syringe), pre-service
The denial is upheld.

The patient is an adult male with atopic dermatitis, treated with topical steroids, topical calcineurin inhibitors, emollients and Adbry in a clinical trial.  The provider is requesting Adbry as the patient responded favorably to this medication.  The health plan requires use of a systemic immunosuppressant.

The proposed treatment is not medically necessary.

Cyclosporine and other systemics have been well studied for atopic dermatitis and are also recommended based on current guidelines.  Biologics are next line therapy after these have failed.  Therefore, Adbry is not medically necessary.

According to the recommendations provided by Simpson et al (2017), steps taken before commencing systemic therapy include considering alternate or concomitant diagnoses, avoiding trigger factors, optimizing topical therapy, ensuring adequate patient/caregiver education, treating coexistent infection, assessing the impact on quality of life, and considering phototherapy.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Type 2 Diabetes
Treatment: Januvia (sitagliptin)
The insurer denied the Januvia (sitagliptin).
The denial is upheld.

The patient is an adult female with type 2 diabetes. The request for Januvia is under review. The prior request was denied coverage by the health plan, because approval on criteria requires trial and failure or intolerance or contraindication to Tradjenta. The provider is appealing this determination.

The patient's A1C (glycated hemoglobin) was 10.9% despite taking glipizide and Trulicity. The patient has had side effects on Farxiga, Ozempic, and metformin.

The health plan should not cover the formulary exception for Januvia.

This request is for Januvia for the treatment of type 2 diabetes. The prior request was denied coverage by the health plan, because approval on criteria requires trial and failure or intolerance or contraindication to Tradjenta.

The patient does not have a documented trial with Tradjenta or contraindication to Tradjenta, which is expected to be equally safe and effective as Januvia. In addition, this patient is on Trulicity, and the documentation does not indicate that this medication will be discontinued. Trulicity and Januvia are not recommended for simultaneous use.

Therefore, given the above, the health plan should not cover the formulary exception for Januvia.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: GERD (gastroesophageal reflux disease)
Treatment: Prevacid
The insurer denied the Prevacid.
The denial is overturned.

The patient is an adult female with GERD (gastroesophageal reflux disease). She has failed lansoprazole. Per handwritten notes from the patient, she has failed omeprazole, pantoprazole and rabeprazole over 20 years ago, and has done well on Prevacid. Her provider is requesting continued treatment with Prevacid.

The health plan should cover the formulary exception for Prevacid.

The patient has failed lansoprazole, but there is no chart note documentation that the patient has failed the preferred formulary agents of esomeprazole, omeprazole, pantoprazole or rabeprazole. While there are handwritten notes from the patient stating that she failed omeprazole, pantoprazole and rabeprazole in the late 90s, pantoprazole was not FDA (United States Food and Drug Administration) approved until 2002. That being said, it is evidenced that the patient has failed multiple generic plan preferred PPIs (proton pump inhibitors) in the past. Prevacid was denied coverage by the health plan as the patient has not failed esomeprazole, omeprazole, pantoprazole or rabeprazole. There is no medical literature to support that Prevacid is more effective than esomeprazole, omeprazole, pantoprazole or rabeprazole for the treatment of GERD (gastroesophageal reflux disease). One cannot therefore say that esomeprazole, omeprazole, pantoprazole or rabeprazole would not be effective. Esomeprazole, omeprazole, pantoprazole and rabeprazole do not have more side effects than Prevacid, so are not more likely to have adverse effects. However, as the patient has failed multiple PPIs (proton pump inhibitors) in the past and is doing well on Prevacid, the health plan should cover formulary exception for Prevacid.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: stroke.
Treatment: skilled nursing admission.
The insurer denied Skilled Nursing Facility Admission. 
The health plan's determination is upheld. 

The patient is a male with a significant history of stroke, coronary artery disease, combined systolic and diastolic heart failure, hypertension, chronic kidney disease stage 3, prediabetes, obstructive sleep apnea, seizure disorder and traumatic spinal cord injury T (thoracic) 9 - T10 spinal cord injury status post T7-L1 posterior spinal fusion with resultant with paraplegia, neurogenic bladder and bowel requiring a diverting colostomy. He initially presented to the hospital for sepsis with symptoms of hypotension, near syncope and low-grade fevers. He was found to have deep sacral decubitus ulcer extending to the level of the sacrococcygeal junction with destruction of the coccyx. 

The Skilled Nursing Facility Admission is not medically necessary for this patient. Per the clinical information provided, the patient no longer requires intravenous antibiotic therapy for treatment, there was no documentation of wound care requiring skilled nursing and he is able to feed himself by mouth. In addition, there is no documentation he requires nursing >= 4 hours per day and per the physical & occupational therapy services he can only tolerates < 1 hour per day and is recommended for 3 - 5 days per week. The patient does not require skilled nursing services and/or having a new impairment or documentation of a rehabilitation potential with an expectation for clinical improvement requiring minimum of 1 - 2 hours per day for five days or more per week. Also, there was no documentation that treatment was precluded in a lower level of care. Therefore, the Skilled Nursing Facility Admission is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Cancer
Radiation therapy

Diagnosis: breast cancer
Treatment: proton beam therapy
The insurer denied proton beam therapy. The health plan's determination is overturned.

This is the case of a female patient who presented with R (right) breast cancer. She had a mastectomy followed by chemotherapy. She presented with recurrence in the internal mammary node and was treated with chemotherapy. She is being evaluated for radiation therapy (RT) using Proton beam therapy. 

The requested Proton Beam Radiation Therapy is medically necessary for this patient.
This is young patient with isolated metastatic cancer which needs to be treated for local control. She was treated two times with cardiotoxic chemotherapy. The target area is near the heart and the DVH (dose-volume histogram) comparison of photon and proton showed that the mean heart dose from Photon is 9.19 which is Quantac violation. The mean Heart dose from proton is 1.3 which is well below accepted dose to heart. Thus, sparing of surrounding normal tissue cannot be achieved with photon technique.
Thus, Proton beam therapy is medically necessary/appropriate in this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal/Osteoarthritis/Osteoarthritis of the knee.
Treamtent: Pharmacy/Prescription Drugs/Zilretta 32 milligrams (MG) INJ (injection). 
The health plan denied the requested Zilretta 32 milligrams (MG) INJ (injection) as not medically necessary. 
The health plan's determination is upheld.

This case describes a female patient who underwent a right knee arthroscopic partial medial meniscectomy and microfracture/biocartilage treatment of a medial femoral condyle chondral lesion. This was followed by a course of viscosupplementation injections and oral Meloxicam. The patient was then seen for a follow up examination. The progress note states that the patient is in physical therapy and her pain was controlled with oral medications. The plan was to proceed with a Zilretta injection for the right knee, but the patient's health plan denied this request.
At issue in this case is the medical necessity of the requested Zilretta right knee injection.

I uphold, in whole, the health plan's determination of medical necessity in this case.

The requested health service/treatment of Zilretta 32 milligrams (MG) INJ (injection) is not medically necessary for this patient. This determination is based upon the provided medical records and the current, peer-reviewed literature. A recent article in the Journal of Bone and Joint Surgery published by Conaghan and colleagues in 2018 showed that improvements in osteoarthritis pain were not significant for an injection such as Zilretta compared to standard Triamcinolone Acetonide. In addition, the provided records document that the patient had relief of right knee pain from the prior viscosupplementation injections. The right knee examination revealed no effusion, normal range of motion, and a negative McMurray's test. Therefore, neither the provided records, nor the peer-reviewed literature support the performance of a Zilretta right knee injection for this patient. The denial should be upheld.