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

Diagnosis: Crohn's disease. 

Treatment: Stelara 90 milligrams (mg)/milliliter (mL). 

The insurer denied coverage for Stelara 90 mg/ml to treat Crohn's disease.

The denial is overturned. 

This is a male patient with a history of fistulizing Crohn's ileocolitis. He presented to the gastroenterologist's (GI) for a follow up visit for Crohn's disease. The physician recommended continuation of oral (PO) Asacol as ordered and administering Stelara every 4 weeks. Coverage for Stelara 90 milligrams (mg)/milliliter (mL) was requested.

Stelara for the treatment of Crohn's disease is likely to be more beneficial. It is common practice that if a medication is working to increase dosing frequency. Switching medication would jeopardize the patient's clinical stability. 

"Dose, frequency, and duration of treatment that can affect the effective concentration in the blood are considered important for IBD [inflammatory bowel disease] treatment. Shorter intervals, increased doses or switching to other biologics may help patients to maintain remission and avoid adverse effects and paradoxical reactions" (Chao, et al., 2018).
 
"Conclusions: Among patients with IBD, dose escalation occurred with all TIMs [targeted Immunomodulators]  examined with varying degrees of prevalence and magnitude. Real-world utilization patterns of TIMs indicate that dose escalation is an important part of the clinical management of IBD" (Ehrenberg, et al., 2020).
 
"Ulcerative colitis is a chronic inflammatory disease affecting the colon, and its incidence is rising worldwide.  The pathogenesis is multifactorial, involving genetic predisposition, epithelial barrier defects, dysregulated immune responses, and environmental factors.  Patients with ulcerative colitis have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon.  Ulcerative colitis usually presents with bloody [diarrhea] and is diagnosed by colonoscopy and histological findings" (Ungaro, et al., 2017).
 
Stelara (ustekinumab) 90mg/ml subcutaneously once every four weeks is the best available treatment, there are improved outcomes noted in the literature. This treatment is likely to be more beneficial than any standard treatment without increased risk.
 
The carrier's denial of Stelara 90 mg/ml to treat Crohn's disease should be overturned.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease. 

Treatment: Stelara 90 milligrams (mg)/milliliter (mL).

The insurer denied coverage for Stelara 90 mg/ml to treat Crohn's disease.

The denial is overturned. 

This is a male patient with a history of fistulizing Crohn's ileocolitis. He presented to the gastroenterologist's (GI) for a follow up visit for Crohn's disease. The physician recommended continuation of oral (PO) Asacol as ordered and administering Stelara every 4 weeks as the patient previously developed an abscess while on an 8-week dosing schedule. Coverage for Stelara 90 milligrams (mg)/milliliter (mL) was requested.

The present course is not working so a change is requested. There is no guideline or society recommending Stelara for every 4 weeks although abstracts and anecdotal studies have shown efficacy. In principle the American Gastroenterological Association (AGA) Guidelines reference reducing time intervals or increasing the doses of biologics when a patient is not responding. There is literature showing improvement with every 4 week dosing.  This patient has no option except to try Stelara 90mg every 4 weeks. The AGA commented on the schedule of dose modification of a biologic and there is literature showing efficacy for patients having failed previous biologics. Escalating doses of biologics including Stelara is recommended in AGA and American College of Gastroenterology (ACG) Guidelines.

This patient has severe disease and is an excellent candidate for escalation of Stelara. 

Guidelines recommend utilizing dose escalation or shortening of administration within a class before switching to a different class.
 
There is literature with escalation of Stelara showing no worsening of outcomes compared to standard dosing.  Escalation is safe.  Stelara 90mg every four weeks is likely to be more beneficial than standard therapies.

The carrier's denial of Stelara 90 mg/ml to treat Crohn's disease should be overturned.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease. 

Treatment: Stelara 90 milligrams (mg)/milliliter (mL).

The insurer denied coverage for Stelara 90 mg/ml to treat Crohn's disease.

The denial is overturned. 

This is a male patient with a history of fistulizing Crohn's ileocolitis. He presented to the gastroenterologist's (GI) for a follow up visit for Crohn's disease. The physician recommended continuation of oral (PO) Asacol as ordered and administering Stelara every 4 weeks. Coverage for Stelara 90 milligrams (mg)/milliliter (mL) was requested. 

Ollech, et al. concluded that shortening the ustekinumab 90 mg dose to every four weeks in patients with Crohn's disease, who did not respond to doses every eight weeks, improved clinical and biologic indices of disease activity.

This patient had previously been on Stelara every eight weeks.  While on this dosage, he had a subsequent hospitalization with active perianal disease.  Based on his history, a dose escalation of the Stelara is more likely to improve health outcomes.  The scientific literature supports the use of Stelara at four week intervals.  The standard Food and Drug Administration (FDA) approved dose is to give the Stelara every eight weeks.  However, this patient is a good candidate for Stelara every four weeks due to his complicated history of severe Crohn's disease even when he was on Stelara.  Stelara is the best available treatment for this patient and will hopefully result in the patient not needing a diverting ileostomy.  It has been shown to be safe for patients to receive the dose escalation.  Due to the severe perianal disease, Stelara 90 mg every four weeks is likely to be more beneficial for this patient than standard treatments.  The risk over standard treatment is not increased.  

The carrier's denial of Stelara 90 mg/ml to treat Crohn's disease should be overturned.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Psoriasis. 
Treatment: Taltz. 

The insurer denied Taltz. 
The determination is upheld. 


The patient has moderate to severe psoriasis (in particular, palmoplantar psoriasis). The patient has tried and failed topical clobetasol, betamethasone, topicort, and other topical steroids, as well as oral prednisone. Due to concern regarding fatty liver disease, methotrexate has been avoided. The patient has tried and failed oral Acitretin and Otezla, as well as the biologic medication Humira. Taltz is under review. 

The patient has no documented treatment failure with, or true medical contraindication to, either Cosentyx, Enbrel, Cimzia, Skyrizi, Stelara, or Tremfya. Although Enbrel has a similar mechanism of action as Humira (Tumor Necrosis Factor inhibitor) it has a psoriasis area and severity index (PASI) 75 reduction score of only 50-55% (percent) at four months, while the failed Humira has up to 70-75% at four months. Enbrel would therefore (more likely than not) fail to control this patient after Humira failure. Cimzia is another Tumor Necrosis Factor inhibitor but with a different binding site than Humira, so that Cimzia is a viable possibility for clinical success. The options of Skyrizi, Stelara, Tremfya and Cosentyx involve different biologic mechanisms of action and are particularly of important consideration for this patient. 

All of the formulary drug alternatives (perhaps with the exception of Enbrel) are of similar efficacy and are likely to achieve clinical success for this patient, and with no greater incidence of adverse effects, than the requested Taltz. Therefore, consistent with current medical literature [1-4], the requested Taltz is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal/Back Pain
Treatment: Skilled Nursing Facility
The health plan denied the requested continued subacute rehabilitation stay as not medically necessary. 
The health plan's determination is upheld.

The patient is a male with a past medical history significant for chronic low back pain, spinal stenosis with chronic right lower extremity weakness, hypertension, dyslipidemia, diabetes and chronic obstructive pulmonary disease (COPD). He was admitted to Subacute Rehabilitation following hospitalization related to a fall.
At issue is the medical necessity of the requested continued subacute rehabilitation stay.

This reviewer upholds, in whole, the health plan's determination of medical necessity.

No, the requested health service of Continued Subacute Rehabilitation is not medically necessary for this patient. He was ambulating 150' with supervision and had completed 12 steps with supervision. He was modified independent for bed mobility. 
The patient required stand by assist (SBA) for bed mobility and minimum assistance (MINA) for transfers. He could ambulate 25' with MINA. He later had progressed to supervision for bed mobility and SBA for transfers. He was ambulating 40' with contact guard assist (CGA). Steps had not been tried. He later had further progressed to supervision for transfers, 75'with SBA. The patient still had not completed stair training secondary to pain in his spine. He later was ambulating 150' with supervision and had completed 12 steps with supervision. He was modified independent for bed mobility. While he was noted to have continued back pain, this is a chronic problem and as noted in the hospital ER note he had been seen in the ER for low back pain and right lower extremity weakness with MRI imaging noting severe central canal stenosis at L3-4 with severe right sided neuroforaminal stenosis. He was supposed to follow up with neurosurgery but did not because of transportation. While this patient unfortunately has chronic pain related to lumbar stenosis, he is medically stable, doing appropriately well with transfers, bed mobility, ambulation and stairs and needs to discharge to a lower level of care and follow-up with neurosurgery.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's disease
Treatment: Stelara
The insurer denied Stelara 90 mg every 4 weeks. The health plan's determination is overturned. 

The patient is a female with Crohn's disease (ileocolitis). She has failed mesalamine (Lialda, Apriso, Pentasa, Canasa), corticosteroids (prednisone, Uceris foam and tablets, Proctofoam), high-dose Remicade complicated by drug-induced lupus, and Stelara every 8 weeks and every 7 weeks. She started Stelara. She had a disease flare recently while on Stelara every 7 weeks, with profuse bloody diarrhea, abdominal pain, nausea, vomiting, chills, and low-grade fever. Fecal calprotectin was elevated at 859. She had a cerebrovascular accident during a Crohn's disease flare recently. She started Stelara 90 milligrams (mg) every 4 weeks. Testing 4 weeks after Stelara injection showed Stelara level of 3.8 (and lack of anti-Stelara antibodies).

Stelara to 90 mg every 4 weeks is medically necessary and is supported in this case by current medical literature. Stelara is Food and Drug Administration (FDA) -approved for the treatment of Crohn's disease. A large randomized controlled trial demonstrated safety and efficacy of Stelara for induction and maintenance of remission in patients with moderate-severe Crohn's disease. Guidelines for the treatment of Crohn's disease recommend the use of Stelara. In this case, the patient has severe disease based on extensive disease requiring colectomy. A study showed dosing intensification (90 mg every 4 weeks) was used frequently to address loss of response, and a large proportion of patients were able to maintain response. One study showed that dose escalation was required and approximately half of patients, and successful in 61.1% of dose escalation attempts. Another study showed efficacy of dose escalation to recover lost response in 73% of patients in whom it was attempted.

In this case, the patient has failed Stelara every 8 and 7 weeks, and has had some disease symptoms requiring corticosteroids even on Stelara 90 mg every 4 weeks. The discontinuation of dosing every 4 weeks (even if an alternative therapy is attempted immediately) may result in complications such as fistula, stricture, bowel obstruction, flare, hospitalization, need for surgery, or other complications in this patient with moderate to severe disease. For all of these reasons, continuation of Stelara 90 mg every 4 weeks is medically necessary for the treatment of this patient's Crohn's disease.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hydradenitis Suppurativa.
Treatment: Cosentyx.
The insurer denied the Cosentyx.
The determination is upheld.

The patient has a diagnosis of hidradenitis suppurativa. The hidradenitis is Hurley Stage III. He has tried and failed Humira. He has also tried benzoyl peroxide wash, clindamycin, doxycycline, and prednisone. The medication under review is Cosentyx.

The requested treatment, Cosentyx, is not medically necessary.
The documentation submitted by the patient's provider does not meet medical necessity. There is no documentation provided that the patient has an approved condition for use of the requested drug, such as the conditions of psoriasis, psoriatic arthritis, or ankylosing spondylitis.
This medication is not medically necessary to treat and manage the condition of this patient. The submitted documentation was reviewed, however, there were no details provided as to the dose or duration of the treatments tried and failed. There was also no documentation provided that the patient has tried and failed widely used and conventional therapy. According to the evidence-based dermatology literature and textbooks, oral antibiotics in combination are effective treatments for the management of hidradenitis suppurativa (1,2). The "North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations: Part II: Topical, intralesional, and systemic medical management" says "Systemic antibiotics have been a mainstay of HS treatment for decades, with many regimens reported" (3). The authors go on to explain further "Clindamycin and rifampin in combination have been studied in HS more than most other antibiotics, typically with both used at a dose of 300 milligrams (mg) twice daily. A systematic review of retrospective and prospective series reported response rates from 71% to 93% in 187 patients, strongly favoring their use. Treatment typically lasts 8 to 12 weeks and can be repeated intermittently as monotherapy in patients with mild-to-moderate disease or as adjuvant therapy in those with severe disease." (3). Within the peer-reviewed literature, Dessinoti et al writes "Oral clindamycin with oral rifampicin for 12 weeks is an effective and tolerable regimen for HS" (4). Bettoli et al writes "Clinical remission can be obtained in patients with ...S using oral antibiotics (clindamycin-rifampin... combinations... (5).
It is noted that the patient has tried and failed several therapies, including Humira. However, after review of the clinical documentation, there is no documentation provided that would justify the patient requiring treatment with Cosentyx for a diagnosis of hidradenitis suppurativa, especially prior to a trial and failure of conventional therapy.
Therefore, Cosentyx is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. Treatment: Pharmacy/Prescription Drugs. The insurer denied Humira 40 milligrams (mg) for medical necessity. The denial was overturned. 

This patient is a male patient with severe universal ulcerative colitis. He was started on Humira at standard but was not responding. Therefore, the attending gastroenterologist escalated the dose of Humira to 40 milligrams (mg) every week to treat his severe ulcerative colitis. A colonoscopy revealed active inflammation and therapeutic drug monitoring revealed low levels of Humira (adalimumab). Therefore, the attending provider would like to escalate the dose of Humira further to 80 mg every week.
At issue is the medical necessity of Humira 40 mg. 

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

The requested health service/treatment of Humira 40 mg is medically necessary for this patient.
Dose escalation in biological therapy used to treat inflammatory bowel disease is a well-accepted practice and supported by literature in patients who are not responding to standard dosing of the medication. This can be done by a dose increase or shortening the interval between infusions and sometimes a combination of both a dose increase and shortening the interval between doses.
There is clinical data from well-conducted randomized controlled or comparative controlled cohort trials in the prevailing peer-reviewed published medical literature that are adequate to conclude that Humira is effective for the treatment of ulcerative colitis.
Therefore, the treatment of Humira 40mg is medically necessary.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Atrial Fibrillation.

Treatment: Pradaxa (dabigatran).

The insurer is denied coverage for the Formulary Exception Pradaxa (dabigatran).

The denial is overturned. 

This male patient has a history of hypertension, possible transient ischemic attack (versus migraine), melanoma and early persistent symptomatic atrial fibrillation, status post radiofrequency ablation and Zio patch. The patient was enrolled in the Option trial and randomized to anticoagulant therapy. He has experienced intense pruritus with occasional erythema and hives, felt possibly related to Xarelto, and has also experienced diarrhea with Eliquis. Pradaxa is requested; a trial of 150 milligrams twice daily is planned.

The insurer has denied coverage for Pradaxa (dabigatran). In their Final Adverse Determination letter, they write that the request did not meet their established criteria. Formulary alternatives include warfarin, Eliquis and Xarelto.

Northwell Health Physician Partners are appealing the denial. Per the appeal application, the patient has a history of persistent symptomatic atrial fibrillation. He had intense pruritus with hives from Xarelto, and severe diarrhea with Eliquis.

This is the case of a male with a history of persistent atrial fibrillation (AF), transient ischemic attack (TIA), and hypertension. He developed side effects to apixaban (diarrhea) and rivaroxaban (itching and rash). His physician prescribed dabigatran as an oral anticoagulant, to prevent thromboembolic stroke.  

This patient has a CHADSVASC [congestive heart failure, hypertension,  diabetes mellitus, stroke (double weight)] score of 4 (age, hypertension, TIA) and has an elevated risk of thromboembolic stroke. (1) 

Current American Heart Association (AHA)/ American College of Cardiology (ACC)/ European Society of Cardiology (ESC)/ Heart Rhythm Society (HRS) guidelines recommend oral anticoagulant therapies for prevention of stroke in patients with AF. (2) Novel oral anticoagulant (NOAC) medications have been demonstrated to be non-inferior and in some cases even superior to warfarin therapy. 

In this case, the patient has had intolerance to both apixaban and rivaroxaban. Treatment with dabigatran is indicated here. The patient has had adverse reactions to two formulary drugs. NOACs such as dabigatran are recommended by the guidelines over warfarin (Class IA indication) as NOACs have been shown to have fewer adverse effects while preventing thromboembolic stroke. (2) 

The insurer's denial of coverage for the Formulary Exception for Pradaxa (dabigatran) is reversed. 

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

The carrier's denial of coverage for the Pradaxa (dabigatran) is overturned.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Anaphylaxis

Treatment: Inpatient day

The insurer denied coverage for inpatient day.

The denial is upheld.

The patient is a male with a past medical history of allergies to peanuts and kiwi who presented emergency department. He had an apparent ingestion related anaphylactic reaction (hives/emesis) initially treated in an outpatient basis with epinephrine and Decadron but subsequently sent to the emergency department for continuing symptoms. In the emergency department, the patient had recurrence of hives as well as flushing. He was treated with parenteral famotidine, Solumedrol and Benadryl. He was subsequently transferred to the Pediatric Intensive Care Unit (PICU) where he stayed overnight with continued steroids, histamine blockade. His discharge note indicated that the patient had  no skin lesions or allergic symptoms. None of the vital signs indicated signs/symptoms of lower or upper airway compromise and vital signs were consistently normal. There was no consultation with Ear Nose & Throat or anesthesiology to evaluate for airway angioedema or the need for airway protection. There was no record of bronchospasm treatment or epinephrine administrations in the hospital or emergency department. In summary, this child had some recurrence of urticaria after an apparent food related allergic reaction. This could have been followed in an observation setting instead of requiring an intensive care admission. The hospital stay not including emergency department treatment was less than 24 hours and was closer to 12 hours. None of the treatments given required a hospital setting including steroids, antihistamines and histamine blockers. The intravenous fluids were not given on the basis of volume depletion or hypotension. 

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

The insurer's denial of coverage for the inpatient day is upheld. Medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Pregnancy/Childbirth-miscarriage
Treatment: Lab work/Blood Tests-genetic testing
The health plan denied genetic testing as not medically necessary. 
The reviewer has upheld in whole the health plan's determination.

This is a patient with a missed abortion and a dilation and curettage (D&C) procedure. Factor II, MTHFR, and Factor V mutation testing were ordered. Coagulation Factor V Leiden gene mutation test, CPT 81241, is under review for medical necessity.

Data demonstrating an association between a missed abortion and the service under review is not available. The test is not recommended for use in this clinical scenario by the peer-reviewed literature nor by the American College of Obstetrics and Gynecology, nor by the authors of UpToDate. The historical information provided does not indicate that this patient has a personal or family history of thrombophilia and while a patient may be a carrier for one of these genes, treatment is not typically altered based on the results of the studies. As the results do not alter management nor outcomes and support in the literature is lacking, medical necessity for the service cannot be established.