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

Diagnosis: Cardiac/Circulatory Problems. 
Treatment: Eliquis. 

The insurer denied Eliquis.  The denial is overturned.

This patient is a female with a past medical history of hypertension, hyperlipidemia, diabetes mellitus, persistent atrial fibrillation with multiple cardioversions in the past, and prior embolic event to her eye (retinal artery branch occlusion) while on treatment with Xarelto. The patient has been doing well on treatment with apixaban (Eliquis). The patient's health plan has denied prescription benefit exception coverage for apixaban stating that documentation does not demonstrate failure, intolerance, or contraindication to formulary anticoagulants, warfarin and Xarelto. The patient's provider is requesting appeal of this decision for continued treatment and coverage with apixaban (Eliquis).

The health plan's determination is overturned in whole.

Eliquis is the most appropriate anticoagulant for treatment of atrial fibrillation and to reduce this patient's risk of stroke and systemic embolism. The alternative formulary anticoagulants, warfarin and Xarelto, are medically inappropriate for this patient because the patient has already failed treatment with Xarelto as documented by a history of an embolic event to her eye while being treated with Xarelto. In addition, current published medical literature, and expert consensus guidelines on the management of anticoagulation to prevent stroke and systemic embolism in patients with atrial fibrillation recommend preference of direct oral anticoagulant apixaban (Eliquis) over warfarin for stoke prevention based on a superior safety profile due to lower risk of major bleeding events. (1) Documentation satisfies criteria for prescription benefit exception coverage for Eliquis. The formulary alternatives warfarin and Xarelto would be medically inappropriate and unsafe for the patient in this case.

Therefore, Eliquis would be more effective than the formulary alternatives, warfarin or Xarelto.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Dermatitis. 
Treatment: Dupixent. 

The insurer denied Dupixent. The health plan's determination is upheld. 

The patient is a female with moderate to severe atopic dermatitis. The patient has under 10% body surface area involvement but does have involvement of the hands and feet that affects daily activity. Dupixent has successfully treated her condition, and continuation of her current treatment with Dupixent is being requested for coverage by her dermatologist. The correspondence reports that the patient has been receiving Dupixent due to the manufacturer's assistance program. The patient has been also using topical Clobetasol and Protopic. 

Dupixent is not medically necessary. 

The patient has no documented treatment failure with, or true medical contraindication to, either of the standard, first-line oral medications used for moderate to severe atopic dermatitis (such as Methotrexate, Azathioprine, Cyclosporine, or Mycophenolate Mofetil). Dupixent is not proven to be superior to all other formulary alternatives as per comparative, controlled studies. Dupixent has been used out of convenience and not medical necessity. Therefore, consistent with standards of care, Dupixent is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Pulmonary Embolism.
Treatment: Inpatient admission.

The insurer denied coverage for inpatient admission.  The denial is upheld.

The patient has a history of testicular cancer and prior deep vein thrombosis (DVT). The patient had not been on anticoagulants at the time. The patient was diagnosed with COVID (coronavirus).  The patient presented to the emergency department (ED) with complaints of left lower calf pain. The patient was tachycardic, denied fever, chest pain (CP) and shortness of breath (SOB).  Vital signs:  Temperature 99.3, Blood Pressure 128/59, Heart Rate 115, Respiratory Rate 22, and Oxygen (O2) saturations 100% (percent). The patient was alert and oriented x3 (person, place, and time), in no acute distress (NAD), Lungs were clear, and cardiovascular systems (CVS) were normal. The patient was tachycardic, with cyanosis, clubbing or edema. The patient had some left calf pain on palpation.  White blood cell count (WBC) was 9.8, hemoglobin (Hb) 14.9, electrolytes were within normal limits (WNL). COVID Test was positive. Creatine phosphokinase (CPK) was normal and   Troponin was normal. Chest x-rays revealed (CXR) no acute pathology.

Computerized tomography angiography (CTA) revealed bilateral (B/L) pulmonary embolism (PE). There were also some bilateral ground glass opacities consistent with COVID.  The patient was not hypoxic, was admitted for the treatment of pulmonary embolism (PE). The patient was started on Apixaban.  Echocardiogram did not reveal any right heart dilatation or strain. Left ventricular function was normal. DVT was negative. The patient was treated with Heparin drip for PE as there was concern that he had failed oral (PO) anticoagulation (AC).  A hematology consultation was obtained. They opined that this patient had not failed oral anticoagulation (PO AC). He had not been on AC, so it was not a failure and they recommended to start back on PO AC.

The patient remained stable after admission (other than some tachycardia). The patient was not hypoxic. Oxygen saturation was 97% on room air.  This patient was switched to oral (PO) Apixaban as per Hematology recommendations and was discharged home.

This patient did not need acute inpatient hospitalization. He could have been placed in Observation status while diagnostic testing and treatment were initiated. Observation periods could be for up to 48 hours. The patient was stable after admission and could have been discharged home on PO Apixaban for his PE after a period under observation. The patient was stable for follow up (FU) in outpatient setting after that.

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

The insurer's denial is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Uncontrolled Diabetes.
Treatment: Inpatient hospital stay.

The insurer denied coverage for inpatient hospital stay.  The denial is overturned.

This is the case of a male who presented to the Emergency Department (ED) for a blood sugar over 300 and hemoglobin A1c (glycated hemoglobin) of 14.3 in the physician's office. The patient also reported unintentional weight loss over a few months duration. He had an elevated serum beta hydroxybutyrate. He was started on intravenous (IV) fluids and treated for new onset diabetes mellitus. He was given insulin and continued on IV fluids. The patient was discharged with subcutaneous insulin and instructions for outpatient follow up.
	
Diabetes education consists of several components, nutritional counseling, self-monitoring of blood glucose and treatment of hyper and hypoglycemia. The standard of care is that all patients with diabetes should receive all these components. [1, 2] 

Practice patterns differ depending on the availability of educators, etc. Whether a patient gets hospitalized for intensive insulin therapy initiation depends on the available program where the patient is seen.

The majority (75% [percent]) of medical centers in the US (United States) [3] that treat new onset type 1 diabetes admit their patients. According to the ADA (American Diabetes Association) statement on treatment of type 1 diabetes [4], hospitalization is necessary regardless of severity if, "the center is not experienced in the outpatient management of newly diagnosed children with diabetes or is not adequately staffed to provide outpatient care because regional health care reimbursement is inadequate for initial outpatient care and education." In type 1 diabetes, the initial hospitalization is to educate the patient and the family in self-injection, drawing up and mixing of insulins, checking blood sugar, recognizing and responding to hyper and hypoglycemia, and evaluating ketosis, as well as nutrition education on carbohydrate counting because there is only one treatment option (insulin). Learning these skills is an overwhelming task for most patients and families and is the reason that this is done with a 2-3 day admission to the hospital. [5, 6, 7, 8]

The patient presented with new onset uncontrolled diabetes that was symptomatic with large ketones requiring immediate insulin initiation and education. The patient received such education and the doses of insulin were titrated until the ketones cleared and the patient was safe for discharge. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.

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

The insurer's denial of coverage for the inpatient hospital stay is overturned. Medical Necessity is substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: chronic low back pain, cervical spondylosis and pain

Treatment: Intracept Procedure

The insurer denied coverage for the Intracept Procedure

The denial is upheld

The patient is a female who presented with a history of back pain. The patient also had cervical (C) spine pain that radiated across the C-spine, with intense headaches. There was radiation of pain to the shoulders and upper back as well. The pain was constant and aggravated with movement. The patient report pain was seven out of ten. Exam of cervical spine noted positive thrombotic thrombocytopenia purpura (TTP) rhomboids and trapezius bilateral; positive facet loading bilateral.  Lumbar spine exam noted a mild antalgic gait. The bilateral paraspinal had tenderness to palpation. There was positive facet loading, bilateral, with limited range of motion of the lumbar spine. Diagnoses included cervical spondylosis, low back pain, lumbar radiculitis, and occipital neuralgia.

According to an appeal letter, "The patient had a history of low back pain for over months. The patient has tried and failed: lumbar epidural steroid injections, medial branch blocks, physical therapy, home exercise program, and medication management (nonsteroidal anti-inflammatory drugs and opiate analgesics). The patient's magnetic resonance imaging demonstrates Modic type degenerative end-plate changes, consistent with causing vertebrogenic pain. Nothing will ablate the pain generated by the basivertebral nerve, short of its ablation."

Per Fischgrund, et al., "Conclusion: Patients treated with radiofrequency (RF) ablation of the BVN [basivertebral nerve] for CLBP [ chronic low back pain] exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain." 

Becker, et al., write that, "Lumbar axial back pain arising from degenerative disc disease continues to be a challenging clinical problem whether treated with nonsurgical management, local injection, or motion segment stabilization and fusion." 

Khalil, et al., (2019) write that, "Current literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain(LBP) that is not adequately addressed by standard of care. Prior 2 year data from the treatment arm of a sham-controlled randomized controlled trial (RTC) showed maintenance of clinical improvements at 2 years following radiofrequency (RF) ablation of the basivertebral nerve (BVN)."

The Intracept procedure does not have final approval from the appropriate regulatory bodies for this diagnosis.

Though the patient has a history of chronic pain, the requested procedure is still considered investigational. There have not been large enough studies to support efficacy and safety.

The requested service is not likely to be more beneficial than any standard treatment/procedure and the adverse risks are increased over other treatments/procedures.

The insurer's denial of intracept procedure is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atypical Chest Pain

Treatment: Inpatient hospital stay

The insurer denied coverage for the inpatient hospital stay.

The denial is upheld.

The patient presented to the hospital complaining of chest pain. The past medical history was significant for hypertension, peptic ulcer disease, and chronic obstructive pulmonary disease (COPD). She noted intermittent bilateral chest pain for weeks. After reporting symptoms to her primary care physician, she was sent to the hospital. On arrival to the hospital, vital signs were stable (Blood Pressure (BP) 141/94, Pulse 77). Physical examination revealed no major abnormality. A 12-lead electrocardiogram (ECG) revealed sinus rhythm with no evidence of ischemic ST (interval on ECG) or T (interval on ECG) wave abnormalities. Serum troponin levels were not elevated (<0.03) and exercise stress testing revealed no ischemia. The patient was discharged with cardiology follow up.

The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient. This patient presented with atypical chest pain and a past medical history of hypertension. Her pretest probability of coronary artery disease was low (Reference 1).

Utilizing the HEART [history, ECG abnormalities, age, risk factors, and troponin] score, she was considered low risk (score=3) (Reference 2). Utilizing the TIMI [thrombolysis in myocardial infarction] risk score, she also had a low risk of developing major adverse cardiac events in the subsequent 30 days (Reference 3). Risk assessment of patients presenting with chest pain and no significant ST changes on ECG was reviewed by Hedayati, et al (Reference 3).  

Using the HEART score risk stratification schema, this patient would have a low risk of major adverse cardiac events (defined as myocardial infarction (MI), need for percutaneous coronary intervention (PCI), need for coronary artery bypass grafting (CABG), or death) in the six weeks following presentation. Using the TIMI risk score, this patient would have a low risk of major cardiac events (defined as all-cause mortality, MI, and severe recurrent ischemia requiring urgent revascularization) within the two weeks following presentation. In conclusion, admission to the hospital to treat an acute cardiac event was not medically necessary. In conclusion, this patient could have been treated at a lower level of care.

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

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

Diagnosis: Psoriasis Arthritis
Treatment: Taltz, Pre-service

The insurer denied the Taltz, Pre-service.
The denial is upheld.

The patient is a woman with severe psoriasis and psoriatic arthritis for whom Taltz is requested. She has tried and failed multiple topical steroids (triamcinolone, hydrocortisone, clobetasol), clotrimazole, Lubriderm and Naproxen. She has diabetes mellitus.

No, the requested Taltz is not medically necessary.
The patient has severe psoriasis and psoriatic arthritis. Formulary alternatives, Enbrel and Cosentyx, are both approved for the treatment of psoriasis and psoriatic arthritis. There is no documentation that the patient is unable to use Enbrel and/or Cosentyx. Therefore, Taltz is not medically necessary.

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.
The patient has tried and failed multiple topical therapies but no history of systemic therapies. Both Enbrel and Cosentyx are approved for use in patients with psoriasis and psoriatic arthritis and are available through the formulary. There is no documentation that the patient is unable to use Enbrel and/or Cosentyx. Therefore, Taltz is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriasis vulgaris and psoriatic arthritis

Treatment Taltz autoinjector (2 pack) 80 milligrams per milliliter (mg/ml) auto injector

The insurer denied coverage for Taltz autoinjector (2 pack) 80 milligrams per milliliter (mg/ml) auto injector

The denial is upheld

This is the case of a patient diagnosed with psoriasis vulgaris and psoriatic arthritis.

According to a telemedicine visit, the patient was seen via telemedicine regarding psoriatic arthritis. The patient takes clobetasol for scalp lesions and was previously on Humira.  The patient had discontinued the medication and did not feel comfortable to return to Humira.  There were reports of swelling in the right middle distal interphalangeal (DIP) with limited range of motion.  There was also stiffness in the hips that was worse in the mornings.  Meloxicam did not provide adequate relief.  On examination, there was psoriatic scales to the forehead and scalp.  Dactylitis was in the bilateral third fingers.  The patient was recommended for Cosentyx.

The insurer's preferred drugs are not likely to cause the patient an adverse reaction. The patient was on Humira-adalimumab and did not feel comfortable returning to the medication. However, there was no explanation or rationale as to why the patient was unable to return to the medication.  

There has not been any evidence that one therapy is superior to another in the field of psoriatic arthropathy in terms of safety and efficacy. Furthermore, as reviewed in UptoDate, in a randomized trial of patients with active psoriatic arthritis they found that while Taltz was superior to placebo it "achieved results comparable to adalimumab (40 mg every two weeks by subcutaneous injection."

Given the above, the request medication is not supported, and the prior determination is upheld. 

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

The insurer's denial of coverage for Taltz autoinjector (2 pack) 80 milligrams per milliliter (mg/ml) auto injector is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Spasticity. 
Treatment: 62370 Intrathecal pump interrogation, reprogram, and refill. 

The insurer denied the 62370 Intrathecal pump interrogation, reprogram, and refill. 
The denial is overturned. 

The patient is a male with history of spasticity due to HIV (human immunodeficiency virus) myelopathy. His relevant past medical history includes accidental poisoning with Freon, hepatitis B & C, COPD (chronic obstructive pulmonary disease), UTI (urinary tract infection), BPH (benign prostatic hyperplasia), HIV (human immunodeficiency virus), IV (intravenous)-drug abuse, peripheral neuropathy, bladder stones, and oxygen dependence. In addition, the patient is wheelchair bound. 

The patient has been on an intrathecal Baclofen pump for many years, with a revision several years ago. Its use is for the control of the spasticity secondary to his HIV (human immunodeficiency virus) myelopathy, a form of non-traumatic spinal cord injury. The request by his treating physician is for the intrathecal pump baclofen refill with the required interrogation and reprogramming. The patient had recent refills with spasticity well controlled and without any side effects. The treating physician is concerned that his missing a refill could lead to baclofen withdrawal symptoms. 

Yes, the requested health service is medically necessary. 

The requested intrathecal baclofen pump interrogation, reprogram and refill is medically necessary as this is a national standard of care for spasticity in a spinal cord injury patient. 

According to Elovic et al., "Intrathecal baclofen now plays an important role in the management of spasticity in a number of neurologic conditions including spinal cord disorders. Dosage errors can be a source of significant morbidity and the risk is greatest when the clinician is changing solution concentration." This points to the need for interrogation and reprogramming as part of the refill. 

According to McIntyre et al., "There was substantial level 4 evidence that intrathecal baclofen is effective in reducing spasticity." 

In this instance, the patient has been on an intrathecal baclofen pump for many years with a revision several years ago, and its use is for the control of the spasticity secondary to his HIV (human immunodeficiency virus) myelopathy, a form of non-traumatic spinal cord injury. The request by his treating physician is for the intrathecal pump baclofen refill with the required interrogation and reprogramming. He had recent refills with spasticity well controlled and without any side effects. 

There is concern that his missing a refill could lead to baclofen withdrawal symptoms, including fatality, which is a key reason for the basis as to why this is medically necessary. Therefore, the requested pump and placement is medically necessary. 

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient. 

As noted above, the patient missing a refill could lead to Baclofen withdrawal symptoms, including fatality.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Hypertension
Treatment:  Exforge HCT 320-25 mg
The insurer denied Exforge HCT 320-25 mg.
The determination is upheld.

The patient has a history of hypertension, diabetes, and hypertension. He is requesting coverage for brand-name Exforge HCT [amlodipine, valsartan, and hydrochlorothiazide] 10-320-25. In a letter, the patient's provider stated that the generic version of this combination medication (amlodipine, valsartan, hydrochlorothiazide) caused nausea, vomiting, and abdominal pain, but the brand name product was effective and well tolerated. There are no other medical records in the information provided.
At issue is whether the formulary drug (valsartan-amlodipine-hydrochorothiazide, olmesartan-amlodipine-hydrochlorothiazide) will be or has been ineffective, would not be as effective as the non-formulary drug Exforge HCT 320-25 milligrams (mg), or would have adverse effects.

Although it is possible that the particular generic product that the patient tried (valsartan-amlodipine-hydrochlorothiazide) caused side effects, there is no clear evidence that all of the formulary drugs including combination olmesartan-amlodipine-hydrochlorothiazide, as well as the constituent medications taken individually, will be or have been ineffective, or would have adverse effects.
Although there are no medical records that clearly document that the patient had an adverse reaction on the formulary generic version of valsartan-amlodipine-hydrochlorothiazide, it is possible that the patient had side effects to a particular generic product compared to the brand name version. However, there is no evidence that the patient tried and failed another formulary combination product, olmesartan-amlodipine-hydrochlorothiazide, which is very similar to the requested non-formulary medication. In addition, as these are combination products, there is no evidence that the patient tried and failed the constituent medications as individual products. In addition, another generic product from a different manufacturer could be well-tolerated and effective. Based on the Food and Drug Administration's (FDA's) Orange Book there are at least two pharmaceutical firms manufacturing generic versions of the requested non-formulary. Therefore, based on the standard of care, and the peer reviewed literature cited in the references, the health plan's determination is upheld.