Persius/hicric huggingface dataset:
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: clotting disorder, bilateral pulmonary embolism, acute deep vein thrombosis (DVT)

Treatment: Pradaxa (dabigatran)

The insurer denied coverage for Pradaxa (dabigatran). The denial is reversed. 

This patient is a female with a history of clotting disorder, bilateral pulmonary embolism, acute deep vein thrombosis (DVT) of distal end of left lower extremity, menorrhagia, and hypertension, who presented with thrombophilia.  The patient was seen in second opinion and was found to have deep vein thrombosis (DVT) and bilateral pulmonary embolisms (PE).  She was heterozygous for the prothrombin gene mutation.  The patient has superficial phlebitis in the left lower extremity in the past.  The patient was discharged on Eliquis but had deep vein thrombosis (DVT) on it several weeks after varicose vein surgery.  The patient also had vein stripping several years prior. The patient has been stable on Pradaxa and was to continue on Pradaxa 150 milligrams twice a day.  Formulary alternatives are Eliquis and Xarelto. The patient already failed Eliquis.  It is not likely that Xarelto would cause an adverse reaction; however, given the patient's past medical history of clotting such as PE and DVT it is a risk that doesn't need to be taken.  Furthermore, the patient has been stable on Pradaxa.

Eliquis did not prevent this patient having a DVT a few weeks after being started.  Therefore, the use of Eliquis, formulary alternative has been ineffective for this patient. The patient has an expansive history of clotting and is on a drug, Pradaxa that is currently effective.  Given the patient's stability with Pradaxa, in this case, it is more effective than Xarelto.  Switching from the successful Pradaxa in this context is less effective than continuing Pradaxa.  There are no head to head trials comparing these agents.  However, it is of note that these agents work in different ways.  Pradaxa is the only oral agent that is a direct thrombin inhibitor.  In contrast, both Eliquis and Xarelto are direct factor Xa inhibitors.  

Per Cohen, A. T., Hamilton, M., Mitchell, S. A., Phatak, H., Liu, X., Bird, A., Tushabe, D., & Batson, S. (2015), "Six Phase III RCTs met criteria for inclusion: apixaban (one RCT; n = 5,395); rivaroxaban (two RCTs; n = 3,423/4,832); dabigatran (two RCTs; n = 2,539/2,568); edoxaban (one RCT; n = 8,240). There were no statistically significant differences between the NOACs with regard to the risk of 'VTE and VTE-related death" Per Ogbonna, K. C., & Dixon, D. L. (2015), "Venous thromboembolism (VTE) is a disease comprised of two conditions: deep vein thrombosis and pulmonary embolism.  VTE is a major cause of morbidity and mortality worldwide with an annual incidence estimated at 13 cases per 1,000 individuals.  This incidence increases with age from 0.1 per 1,000 in adolescence to eight per 1,000 in those 80 years of age and older.  Dabigatran has been proposed as a suitable alternative to warfarin therapy in the treatment of VTE." 

The carrier's denial of Formulary Exception for Pradaxa (dabigatran) is reversed.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis Cluster Headaches
Treatment Emgality.  The insurer denied Emgality.
The determination is overturned.

The patient had a listed diagnosis of cluster headaches. The patient is reported to have 5 to 6 episodes of "immense" left eye pain with tearing and rhinorrhea. An appeal letter states that the patient has failed propranolol, Topamax, amitriptyline, verapamil, triptans and oxygen. Emgality substantially improved the headaches as documented in the office visit notes. At issue is the medical necessity of Emgality.
The patient has a diagnosis of cluster headaches and failed several first line treatment options for cluster headaches. It is noted that he has failed propranolol, Topamax, amitriptyline, verapamil, triptans and oxygen. Emgality is Food and Drug Administration (FDA) approved for cluster headaches, and is proven in the high quality peer reviewed literature, with a well-designed, blinded, randomized trial.
Therefore, continuation of Emgality is warranted.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Diverticulitis.
Treatment:  Inpatient Hospital.
The insurer denied the inpatient hospital stay.  The determination is overturned.

This is a patient with a past medical history (PMH) of diverticulosis, diverticulitis and migraines who was admitted with complaints of (c/o) syncope associated with rectal bleeding and bright red blood per rectum (BRBPR).  Vital signs were notable for a blood pressure (BP) of 91/69, pulse of 80.  The physical exam was notable for mild left lower quadrant (LLQ) tenderness to palpation (TTP) and dark maroon blood on rectal examination. Lab work was notable for a hemoglobin of 10.5.  A chest x-ray (CXR)was without acute disease, computed tomography (CT) scan of the head without acute intracranial pathology. An electrocardiogram (EKG) showed normal sinus rhythm (NSR) without acute ischemic changes. The patient was diagnosed with an acute gastrointestinal (GI) bleed and treated with intravenous (IV) fluids, gastrointestinal (GI) consultation, serial hemoglobin and hematocrit (H/H), IV proton pump inhibitor (PPI), IV antibiotics, anti-emetics, octreotide and frequent clinical monitoring.  The patient was discharged in stable condition.  At issue is the medical necessity of an inpatient stay.

The inpatient stay was medically necessary.  This patient presented to the ED with a history of rectal bleeding and BRBPR associated with syncope and hypotension.  Syncope and hypotension are concerning signs associated with an acute GI bleed.  This patient's Oakland Score for Safe Discharge After Lower GI Bleed suggested that the patient be admitted for further workup and resuscitation, given patient's digital rectal exam (DRE) findings, age, pulse, systolic blood pressure and hemoglobin. In addition, the patient's ROSE [risk stratification of syncope in the emergency department] syncope rule indicates the patient with a high-risk syncope, further suggesting that the patient required an inpatient level of care for close clinical monitoring and safe medical treatment.  This patient required frequent clinical monitoring, immediate subspecialty evaluation for possible acute intervention, and serial H&H.  Overall, this patient was not safe for an outpatient level of care and required an inpatient level of care.  Overall, this patient was diagnosed with acute GI bleed and treated with IV fluids, GI consultation, serial H/H, IV PPI, IV antibiotics, anti-emetics, octreotide and frequent clinical monitoring not safe for an outpatient level of care and required an inpatient level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Dementia and psychosis.
Treatment:  Increase PCA level II to 12 hours/day, seven days/week, total of 84 hours/week.

The insurer denied the Increase PCA level II to 12 hours/day, seven days/week, total of 84 hours/week.  The denial is upheld. 

The patient is a female with a history of dementia and psychosis with auditory and visual hallucinations.  Due to impairments related to these conditions, she requires assistance for completion of many of her activities of daily living (ADLs).  Appeal review requested for potential approval of 84 hours/week Personal Assistance Services to offer increased ADL support.

No, the proposed treatment of 84 hours/week Personal Assistance Services is not deemed medically necessary. 

This is a female with a history of dementia and psychosis with auditory and visual hallucinations.  Due to impairments related to these conditions, she requires assistance for completion of many of her activities of daily living (ADLs).  However, an in-home assessment of the patient's functionality and ability to perform ADLs was completed and revealed that the currently approved plan of 49 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 84 hours/week Personal Assistance Services is not deemed medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Type 2 Diabetes Mellitus
Treatment: Saxenda 18MG/3ML SC SOPN
The insurer denied the Saxenda 18MG/3ML SC SOPN. 
The denial is upheld. 

The patient is a male with obesity and type II diabetes with retinopathy on insulin therapy. His A1C (glycated hemoglobin) is 8.3%. He is on Victoza. His provider is requesting Saxenda for higher dose to assist with satiety. 

No, the treatment with Saxenda 18MG/3ML SC SOPN is not medically necessary.

The Endocrine Society guidelines on the management of obesity recommend the use of approved weight loss medication to ameliorate comorbidities and amplify adherence to behavior changes, which may improve physical functioning and allow for greater physical activity in individuals with a body mass index greater than or equal to (>=) 30 kilograms per meter squared (kg/m2) or in individuals with a body mass index of >= 27 kg/m2 and at least one associated comorbid medical condition such as hypertension, dyslipidemia, type II diabetes, and obstructive sleep apnea. It cannot be concluded that these guidelines support the use of Saxenda in this clinical situation, as no clinical documentation was provided to document this patient's body mass index. 

This patient has type II diabetes, but Saxenda is not approved for the use of type II diabetes. The American Diabetes Association clinical guidelines do not support the use of Saxenda for the treatment of type II diabetes. 

Therefore, no, the requested Saxenda is not medically necessary as the documentation does not support that the use of Saxenda is clinically appropriate in this situation.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Stiff person syndrome with acute on chronic
respiratory failure
Treatment: Long term acute care (LTAC) hospital admission
The insurer denied the Long term acute care (LTAC) hospital admission.
The denial is overturned. 

The patient is a female with stiff person syndrome with acute on chronic respiratory failure. She now has tracheostomy and PEG (percutaneous endoscopic gastrostomy) tube feeding. The patient is receiving mechanical ventilation via tracheostomy. The patient is receiving vent weaning trials daily. The patient is working with PT/OT (physical therapy/occupational therapy). The long-term acute care (LTAC) is requested for further care.

The patient is tolerating vent weaning with good progress. The patient is also receiving diazepam for the stiffness and requires closer monitoring of respiratory status. The patient is working with physical therapy and is tolerating PEG tube feeding.  

Yes, the Long term acute care (LTAC) hospital admission is medically necessary.

The clinical progress notes medication list does not include antibiotics. The patient at some point had pneumonia, which was treated with IV antibiotics, but finished the course. The patient's lung status is stable/secured per the progress note. The main issue for LTAC hospital is vent weaning, as well as monitoring of respiratory status, since the patient is on diazepam.

Due to complex medical issues with high risk of respiratory failure from use of diazepam, the LTAC hospital admission is medically necessary. The lower level of care, such as sub-acute rehab would not be safe and not effective.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chrohn's Disease
Treatment: Cimzia 
The insurer denied the Cimzia.
The denial is overturned. 

This is a pregnant female with Crohn's disease. She has tried and failed treatment with Humira. A recent tuberculosis (TB) QuantiFERON test was negative. This was not present when Cimzia was originally denied. The attending physician is requesting treatment with Cimzia. 

Yes, the proposed Cimzia is medically necessary.

The patient has Crohn's disease and has previously failed treatment with Humira. Cimzia was previously denied, as there was no documentation of the patient's TB status. Review of the documentation shows a negative TB QuantiFERON test. The patient is pregnant and Cimzia is safe to use during pregnancy and in lactating women. As the patient has moderate to severe Crohn's disease, has failed treatment with Humira, has a recent negative TB QuantiFERON test, and is pregnant, the proposed Cimzia is medically necessary. The health plan did not act reasonably, and with sound medical judgment and in the best interest of the patient by denying it.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Coronary artery disease; Ischemic cardiomyopathy. 

Treatment: Zoll LifeVest External Defibrillator (K0606RR x1). 

The insurer denied coverage for Zoll LifeVest External Defibrillator (K0606RR x1). 

The denial is upheld. 

This female patient has a past medical history of coronary artery disease, ischemic cardiomyopathy, hyperlipidemia, and diabetes mellitus. Office visit notes documented an impression of cardiomyopathy with dyspnea on exertion, recent cardiovascular stress test abnormal and (three) vessel cardiovascular disease with coronary artery bypass graft (CABG) pending. Treatment with LifeVest and outpatient work up for CABG was planned. A cardiology progress note indicated that the patient had dilated cardiomyopathy with left ventricular ejection fraction of 25-30%, and should continue on LifeVest until the next appointment. 

The patient denied chest pain, shortness of breath, or palpitations. There was no history of unexplained syncope or documented ventricular arrhythmias. The patient's vital signs were unremarkable with pulse oximetry of 93%.  The patient's physical examination showed decreased breath sounds and crackles bilaterally at bases. The patient's telemetry rhythm strip showed sinus rhythm with premature ventricular contractions.  The patient's cardiac catheterization showed three vessel coronary artery disease and ischemic cardiomyopathy. The patient was currently using insulin subcutaneous daily, Coreg, Lipitor, aspirin, Zofran and Tylenol as needed for mild pain. 

The LifeVest is FDA-approved for prevention of sudden cardiac death. However, the use of LifeVest based on the records under review is not considered medically necessary for this patient. The patient was diagnosed with ischemic cardiomyopathy, with ejection fraction of 25-30%, as well as severe coronary artery disease, for which coronary artery bypass graft surgery was advised. LifeVest technology has not been shown to be clinically beneficial when compared with standard-of-care medical therapy for prevention of sudden cardiac death in patients with newly diagnosed ischemic cardiomyopathy. There is no clinical research evidence documenting incremental benefit of this technology over conventional medical therapy, which the patient was receiving, in prevention of sudden cardiac death. The patient's clinical presentation and the absence of extenuating circumstances do not support medical necessity for use of the LifeVest. 

Based on the review of the medical record and literature, a wearable automatic external defibrillator life vest (K0606RR) is not considered medically necessary for this patient. 

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

The carrier's denial of coverage for Zoll LifeVest External Defibrillator (K0606RR x1) should be upheld. The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alopecia areata

Treatment: Xeljanz

The insurer denied coverage for the medication Xeljanz.

The denial is overturned.

This female patient has a diagnosis of alopecia areata and vitamin B12 deficiency anemia. The patient has tried and failed irritant anthralin, topical steroids, and vitamin B12 injections.  The patient has been on Xeljanz Tab 5mg twice daily with reported clinical improvement.

Recent studies have found that JAK inhibitors such as tofacitinib (Xeljanz) is effective in the treatment of moderate to severe alopecia areata (AA) and hair growth. According to Jabbari et al (2018), "open-label studies of ruxolitinib and tofacitinib have shown dramatic clinical responses in moderate to severe AA, providing strong rationale for larger clinical trials using JAK inhibitors in AA" and as per Bokari et al (2018), "topical JAK inhibitors could be developed as a potential new treatment for AA and alternative to clobetasol dipropionate 0.05% ointment."

Almutari et al (2019) found that "[b]oth tofacitinib and ruxolitinib induced remarkable hair regrowth, with a mean change in SALT score of 93.8  3.25 in the ruxolitinib group and 95.2  2.69 in the tofacitinib group."                                                        

Based on the review of the medical record, the patient has alopecia areata refractory to multiple treatment trials. The patient has tried and failed irritant anthralin, topical steroids, and vitamin D12 injections and has been on Xeljanz with reported improvement.  The use of JAK inhibitors has been studied and demonstrated itself to be an acceptable treatment for alopecia areata.  This has been supported by a few studies.  The medical societies in dermatology consider Xeljanz an accepted treatment.  Therefore, considering that this patient has failed on first-line treatment options, Xeljanz is considered medically necessary.

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 Xeljanz should be overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Low back pain. 
Treatment: Artificial Disc Replacement/Lumbar Discectomy. 
The insurer denied the Artificial Disc Replacement/Lumbar Discectomy. 
The denial is upheld. 

This is a female patient with complaints of low back pain that radiates to both legs. She was in a car accident. The patient has tried physical therapy (PT) and epidural injections without relief. She had chiropractic treatment initially. She has tried diclofenac and gabapentin. 

Lumbar provocative discography was concordant at L5-S1 only. Magnetic resonance imaging (MRI) of the lumbar spine showed Modic type 1 degenerative changes at L5-S1 with small disc bulges at L4-5 and L5-S1. The attending physician (AP) recommends L5-S1 lumbar discectomy and disc replacement. 

No, the proposed artificial disc replacement/lumbar discectomy is not medically necessary. 

There is no clear documentation that she has had a sufficient course of physical therapy and non-operative care.  She attended 9 sessions of PT recently but that is not a sufficient course. Without a sufficient trial of conservative care, surgery is not warranted. Lumbar fusion or disc replacement in such a young patient should not be considered unless exhaustive conservative care is attempted first and fails to provide relief. Based on the medical documentation provided, not enough sufficient trial of physical therapy has been attempted to justify the requested procedure.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dementia, hypertension, osteoarthritis
Treatment: Increase Personal Care Worker (PCW) service to 7 days per week, 10 hours per day

The insurer denied the Increase Personal Care Worker (PCW) service to 7 days per week, 10 hours per day. The denial is upheld. 

No, the proposed treatment of an increase in Personal Assistance Services to 7 days per week, 10 hours per day is not medically necessary. 

The patient is a female with a history of Dementia, Hypertension and Osteoarthritis. 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 an increase in Personal Assistance Services to 7 days per week, 10 hours per day to offer increased ADL support. 

Due to impairments related to her conditions, she requires assistance for completion of the majority of her activities of daily living (ADLs). However, an in home assessment of the patient's functionality and ability to perform ADLs was completed and revealed that the currently approved plan of 4 days per week, 4 hours per day and 3 days per week, 5 hours per day, 31 hours per 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 of an increase in Personal Assistance Services to 7 days per week, 10 hours per day is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Multiple medical issues.
Treatment:  Personal Care Aide Service 7 days a week 24 hours a day, live-in.

The insurer denied the Personal Care Aide Service 7 days a week, 24 hours a day, live-in.  The denial is upheld. 

No, the proposed treatment of an increase in Personal Care Aide Service to 7 days a week, 24 hours a day, live-in is not medically necessary. 

The patient is a female with a history of legal blindness, hearing impairment, Diabetes Mellitus, Diabetic neuropathy and urinary incontinence.  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 an increase in Personal Assistance Services to 7 days a week, 24 hours a day, live-in to offer increased ADL support.

An in-home assessment of the patient's functionality and ability to perform ADLs was completed and revealed that the currently approved plan of 7 days a week, 6 hours a day (or 42 hours a 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 of an increase in Personal Assistance Services to 7 days a week 24 hours a day live-in is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Graves' Disease. 
Treatment: Inpatient admission. 

The insurer denied the inpatient admission. The denial is upheld. 

No, the inpatient admission was not medically necessary. 

The patient is a male with Graves' disease who underwent total thyroidectomy. Surgery was uneventful with no preoperative complications. Diet was advanced and the patient was discharged on postoperative day number one without other interventions and will a plan for one-week follow up. 

Care was delivered at a lower level than acute inpatient care.  Total thyroidectomy can be completed as an outpatient safely with appropriate laboratory monitoring or with observation. Surgery was uneventful with no preoperative complications.