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

Diagnosis: Refractory cutaneous warts.
Treatment: Cidofovir.
The insurer denied Cidofovir.
The determination is upheld.

The patient is being prescribed Cidofovir for the diagnosis of treatment-refractory cutaneous warts. Coverage for this medication was denied by the health plan, and this denial is under review.
The patient is not currently being treated with the requested medication. Prior therapy trials have included cryotherapy and salicylic acid.
The patient's prescriber provided a letter of medical necessity for this appeal. The provider has been treating the patient for this condition for several months. She has tried multiple sessions of cryotherapy with liquid nitrogen and topical therapy with salicylic acid the warts did not respond to any of these approaches. The requested medication has been demonstrated in several clinical studies to be a safe and effective treatment option for refractory warts that do not respond to other treatments. The provider strongly believes that the patient would not respond to other options available and that she would benefit from this therapy.
The health plan denied coverage for the requested medication because it is not on the plan formulary. Formulary alternatives available to treat the patient's condition include fluorouracil cream, imiquimod 5 percent (%) cream, and podofilox solution. At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.

The patient has not tried several of the formulary drugs available to treat cutaneous warts, including fluorouracil cream, imiquimod 5% (percent) cream, and podofilox solution. There is no evidence to suggest that these medications would be ineffective for the patient. There is no evidence that these medications would be less effective than the requested medication as there are no head-to-head clinical trials that directly compare the efficacy of these treatments.
The patient's prescriber expressed concern over potential adverse effects. There is no reliable method of predicting whether the patient will have adverse effects on the alternative treatments available to the patient.
Expert opinion on treating cutaneous warts recommend that warts that fail first-line treatment with salicylic acid or cryotherapy be treated with alternative agents such as topical fluorouracil or imiquimod, both of which are treatment options available on the plan formulary (Goldstein et al).
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Glioblastoma multiforme.
Treatment:  Xpovio.

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

This is a male with a glioblastoma multiforme. The tumor was not resectable. The patient has received temozolamide and CCNU/TMZ (lomustine/temozolomide) but has demonstrated increased enhancement on magnetic resonance imaging (MRI).

Xpovio is not medically necessary for this patient.
The use of Xpovio for the treatment or progressive glioblastoma has not been demonstrated to be of benefit; it has not been found to improve any outcome. This agent is the subject of multiple ongoing trials for safety and efficacy in this clinical scenario including, but not limited to, NCT01986348; at this time, its utility remains unproven. For these reasons, Xpovio is not recommended by national guidelines (including the National Comprehensive Cancer Network (NCCN)), the peer-reviewed literature, nor by the authors of UpToDate. For these reasons, medical necessity has not been established.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Rheumatoid arthritis.
Treatment:  Orencia.

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

The patient is a woman with rheumatoid arthritis (RA). Prior treatment has included Xeljanz (not effective), Plaquenil (not working), Prednisone, methotrexate (MTX) (developed oral ulcers), Rinvoq (samples only, some improvement but still with AM (morning) stiffness and swelling) and Humira (stopped due to rash and not effective).

Orencia is not medically necessary at this time.

There is no reason the patient cannot try the formulary medications, Enbrel or Kevzara, which are approved for the treatment of moderate to severe rheumatoid arthritis (RA). As per UpToDate, in patients with an inadequate response to methotrexate (MTX) and other conventional disease modifying anti-rheumatic drugs (DMARDs), the use of combination therapy with the addition of a tumor necrosis factor (TNF) inhibitor is supported by a number of meta-analyses and multiple randomized trials of all five agents'. In patients who have failed TNF inhibitors or have a contraindication to a TNF inhibitor, 'abatacept, the T-cell costimulation blocker, and tocilizumab and sarilumab, the IL-6 receptor inhibitors, may be used as alternatives to a TNF inhibitor in patients in whom MTX plus a TNF inhibitor would otherwise be appropriate, particularly in patients unable to use a TNF inhibitor'.

There is no medical reason the patient cannot try the formulary medications, Enbrel or Kevzara, which are approved for the treatment of moderate to severe RA.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: obesity
Treatment: Wegovy (semaglutide)
The insurer denied Wegovy (semaglutide)

The health plan's determination is upheld. 

This is a female diagnosed with obesity. This request is for Wegovy. As reported, she has obesity with body mass index (BMI) of 38.

The non-formulary drug requested is not clinically appropriate for this patient's condition.
Semaglutide (Wegovy) is a GLP1R (glucagon-like peptide-1 receptor) agonist that is Food and Drug Administration (FDA) approved in the treatment of type II diabetes and obesity. Recent studies published in major peer reviewed medical journals have shown safety and efficacy of semaglutide for the treatment of obesity. This medication is now available for the treatment of obesity in the form of Wegovy.
The standard of care based on multiple societal guidelines requires that the patient participate in lifestyle modification. It also requires that the patient has a body mass index (BMI) of 30 or greater or a BMI of 27 or greater with comorbidities such as hypertension, and hyperlipidemia.
The patient has a BMI of 39.06; however, there is no documentation of participation in lifestyle modifications. The request does not meet the standard of care and is therefore not clinically appropriate.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: History of stomach cancer, OA (osteoarthritis), CAD 
(coronary artery disease), depression and chronic hypoxic respiratory failure
Treatment: Personal Care Aide 24 Hours Live-in, 7 Days Per Week
The insurer denied: Personal Care Aide 24 Hours Live-in, 7 Days Per Week
The denial is overturned.

The patient is an elderly female with a history of stomach cancer, OA (osteoarthritis), CAD (coronary artery disease), depression and chronic hypoxic respiratory failure on supplemental oxygen for whom personal care assistance, 24 Hours Live-in, 7 Days Per Week is being requested.

The request to Increase Personal Care Aide (PCA) to 24 hours/day, live in, is medically necessary.

The patient is an elderly female with a history of stomach cancer, OA (osteoarthritis), CAD (coronary artery disease), depression and chronic hypoxic respiratory failure on supplemental oxygen. The patient lives alone in a one-bedroom apartment, currently on hospice. She is alert and oriented x (times) 3. She has periods of forgetfulness and needs cues to perform multitask activities. The patient needs maximal assistance with meal prep. She is total dependence for housework and managing finances. She needs extensive assistance with managing medications, and she is total dependence for shopping. The patient is wheelchair bound and has shortness of breath and fatigue. She is not able to prepare or warm up her food. She is unable to stand or do any kind of housework. The patient requires assistance from two people for assistance with wheelchair to manage stairs. The patient cannot adjust the flow of her oxygen. She undergoes sponge baths assisted by a person. She has bilateral tremors and needs assistance with brushing teeth, combing hair, putting on clothes, and putting pants on after using the toilet. She needs more than 50% (percent) assistance to transfer to commode or to her wheelchair. She needs one person assistance to manage diapers. The patient can turn from side to side, pull onto sheets, and hold the sides of the mattress for leverage, but she needs to be physically assisted up to sitting. She also needs assistance with spoon feeding.
Patient is frequently incontinent of bladder and is requiring three to four pull ups per day. Per the appeal letter, the patient is homebound and resides alone. She requires 24/7 assistance with a personal care aide to assist with ADLs (activities of daily living). The patient is on hospice and is not expected to recover. Based upon this information, the request for Personal Care Aide 24 Hours Live-in, 7 Days Per Week is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Bladder incontinence, Alzheimer's dementia, hypothyroidism, hypertension, and chronic peptic ulcer disease
Treatment: Increase Personal Care Aide (PCA) and Consumer
Directed Personal Assistance Program (CDPAP) Services for a Total Amount of 84 Hours Per Week
The insurer denied: Increase Personal Care Aide (PCA) and Consumer Directed Personal Assistance Program (CDPAP) Services for a Total Amount of 84 Hours Per Week
The denial is overturned.

This patient is an elderly female with a history of bladder incontinence, Alzheimer's dementia, hypothyroidism, hypertension, and chronic peptic ulcer disease. The patient reportedly requires assistance with frequent diaper changes, assistance with essential tasks such as toileting, bathing, grooming, and meal preparation. The request is to Increase Personal Care Aide (PCA) and Consumer Directed Personal
Assistance Program (CDPAP) Services for a total amount of 84 hours per week.

The request to Increase Personal Care Aide (PCA) and Consumer Directed Personal Assistance Program (CDPAP) Services for a total amount of 84 hours per week, is considered medically necessary.

Per an appeal letter that was reviewed, this patient has physical debility, falls, and bowel and bladder incontinence. The patient's activity logs show that her personal care aides leave at 2:00 in the afternoon, and it is noted that the patient still requires assistance with toileting after the aide has departed. The patient also requires assistance with changes in position, from sitting to standing due to back/knee pain, and she requires significant weight bearing assistance with transfers. Additionally, the patient requires frequent diaper changes to prevent pressure ulcers. Based upon this information, the request for an increase in Personal Care Aide (PCA) and Consumer Directed Personal Assistance Program (CDPAP) Services for a total amount of 84 hours per week is considered medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Migraine Headaches
Treatment: Emgality 120 milligrams (mg)/milliliter (ml)
The insurer denied Emgality 120 milligrams (mg)/milliliter (ml).
The determination is upheld.

The patient has a listed diagnosis of "headaches". The patient was previously reported to have daily headaches, and to take ibuprofen twice daily. No evaluation for rebound headaches is documented, despite such characteristics.
Although an appeal states "all front line typical medication classes" already failed, or are contra indicated, only nortriptyline and topiramate are actually mentioned as prior prophylactic agents tried. No Food and Drug Administration (FDA) listed contraindications to all migraine prophylactic agents are documented. At issue is whether Emgality 120 milligrams (mg) / millilter (ml) pen injector is likely to be more beneficial than any standard treatment or treatment.
Emgality 120 mg/ml pen injector is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Although sometimes used off label, there is insufficient evidence from high-quality peer-reviewed literature, large, well-designed, blinded, randomized trials to support long term safety and efficacy of the requested drug, Emgality, for the requested indication, pediatric headaches, in this patient, as documented.
There is similarly no Food and Drug Administration (FDA) approval, or manufacturer recommendation for such use.
There has been no evaluation for rebound headaches, and Emgality is unproven in the pediatric population. If unproven/off label medications are being considered, there are multiple other frequently used migraine prophylactic agents, of longer treatment experience available.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Migraine Headaches
Treatment: Emgality 120 milligrams (mg)/milliliter (ml)
The insurer denied Emgality 120 milligrams (mg)/milliliter (ml).
The determination is overturned.

This is a female patient who has been diagnosed with chronic migraine without aura. The headaches were occurring daily and were rated as 9.5/10 in severity. The pain was pulsatile, and located in the left greater than right temple, or bitemporal. There were no known triggers. The pain lasted for several hours. She had missed 10 days of school in the preceding school year due to headache. 
Magnetic resonance imaging (MRI) of the brain was normal apart from a small incidental pineal cyst. A general and neurological examinations were normal. 
She has tried numerous abortive and prophylactic medications without improvement in her headache frequency or severity. 
The patient started Emgality 120mg/ml by injection.  She has had a dramatic, 86 percent (%) reduction in her headache frequency. .
At issue in this review is whether the proposed health service or treatment Emgality 120 mg/ml pen injector is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service or treatment Emgality 120 mg/ml pen injector is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Physiologically and anatomically she is essentially an adult female. She has had a dramatic improvement in her headache frequency and severity since starting Emgality, with an overall 86% reduction in headache frequency (from 5 headaches per week to 3 headaches per month). Prior to starting Emgality she had tried numerous abortive and prophylactic medications without improvement in her migraine.
Medications are typically tested and approved for use in adults, with studies being undertaken years later in children, if ever. The American Academy of Pediatrics [1] has issued a Policy Statement for Off-Label Use of Drugs in Children, in which they comment 'off-label drug use remains an important public health issue for infants, children, and adolescents, because an overwhelming number of drugs still have no information in the labeling for use in pediatrics. The purpose of off-label use is to benefit the individual patient. Practitioners use their professional judgment to determine these uses. As such, the term "off-label" does not imply an improper, illegal, contraindicated, or investigational use. Therapeutic decision-making must always rely on the best available evidence and the importance of the benefit for the individual patient.'
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Migraine Headaches
Treatment: Emgality 120 milligrams (mg)/milliliter (ml)
The insurer denied Emgality 120 milligrams (mg)/milliliter (ml).
The determination is upheld.

The patient has migraine headaches without aura. They have worsened in frequency and severity. Without treatment, they now occur 4-5 times per week. As prophylaxis against migraine headaches, she has tried the birth control pill, nortriptyline, and topiramate. As an abortive treatment for migraine headaches, she has tried ibuprofen, Naproxen, Zofran, and Maxalt. None of these medications was effective for her. However, the patient has been treated with monthly injections of Emgality, and the frequency and severity of her migraine headaches are substantially reduced. Whereas, the patient previously had 4-5 headaches per week, she has had only 3 headaches per month since starting the Emgality. In addition, the headaches are less severe since starting Emgality. Emgality is Food and Drug Administration (FDA)-approved only for patients 18 years old or over.  At issue is whether Emgality 120 milligrams (mg) / milliliter (ml) pen injector is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Emgality is not likely to be more beneficial than standard treatment for the patient's migraine headaches. Calcitonin gene-related peptide (CGRP) is a neurotransmitter that is heavily expressed within the trigeminal nerve system and is believed to play an important role in the head pain associated with migraine headaches. Agents that interfere with the CGRP signaling can therefore prevent or abort migraine headaches. Emgality is a monoclonal antibody directed against CGRP. It has been shown to be effective in preventing migraine headaches in adults. However, it has been shown to be safe and effective only in patients 18 years old and older. Emgality is not known to be safe and effective for people of this patient's age. There are several standard therapies that are often effective against migraine headaches that the patient has not yet tried. These include propranolol and amitriptyline. The clinical notes do not explain why propranolol and amitriptyline have not been tried.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Hypotension.
Treatment:  Inpatient stay.

The insurer denied the inpatient stay.  The health plan's determination is upheld. 

The patient is a female with a medical history of anemia, congestive heart failure, chronic kidney disease, diabetes mellitus, dyslipidemia, impaired hearing, hypertension, physical debility, and renal neuropathy, who was brought to the Emergency Department (ED) due to a recent episode of hypotension during dialysis. Emergency Medical Services reported her blood pressure dropping to 60 over 30 (60/30) for 10 minutes during dialysis, and she received 1 hour of dialysis.

Upon evaluation in the ED, the patient reported feeling weak during the dialysis session when her blood pressure dropped. However, she was asymptomatic when seen by the admitting physician.

The inpatient hospital admission was not medically necessary.

The acute inpatient level of care was not medically necessary as there were no signs of hemodynamic instability or severe or persistent altered mental status. There was no mention that the patient had abnormalities in the imaging studies including acute stroke, brain mass, or hydrocephalus.

There was no indication that the presyncopal episode was related to pulmonary embolism, arterial dissection, acute congestive heart failure (CHF) exacerbation, acute blood loss anemia, or acute coronary syndrome. There were no indications for immediate electrophysiological study or other interventions such as automatic implantable cardioverter defibrillator (AICD) placement.

There were no reports that telemetry monitoring revealed evidence of a high degree of atrioventricular block, bradycardia with sinus pauses, or bursts of supraventricular tachycardia. Furthermore, there was no evidence that the patient was severely dehydrated.

The review of the medical records demonstrated that the patient remained in stable clinical condition during the entire hospital stay and did not require any treatment or testing that would justify admission at the acute inpatient level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Major depressive disorder
Treatment: Genomind Profession Pharmacogenetic (PGx)
The insurer denied Genomind Profession PGx.
The determination is overturnted.

This is a male patient in treatment for a mood disorder best characterized as major depressive disorder, single episode with moderate severity with anxious distress and complicated bereavement due to the death of his wife. The patient has a history of treatment refractory anxiety and depression with multiple medication trials combined with psychotherapy over a five-year time frame. 
The requested comprehensive genetic testing analyzes genes implicated in the treatment response to psychotropic medications used to treat mood disorders, as well as psychotic disorders, anxiety disorders, trauma-related disorders, obsessive compulsive related disorders, and attention deficit hyperactivity disorder (ADHD). Genomind Profession PGx was denied by the health plan and is under review for medical necessity.
The requested health service/treatment of Genomind Profession PGx is medically necessary for this patient.
The requested genetic testing in this case scenario does serve to inform treatment to the extent that it is clinically meaningful or useful, especially regarding the potential for adverse drug reactions that could be life threatening or cause irreparable harm to the patient. There is sufficient scientific evidence regarding the effectiveness of genetic testing in this case scenario, and regarding therapeutic decision-making or patient outcomes, as indicated by the scientific literature and guidelines, referenced below.
Thus, treatment could not have as effectively proceeded in this case without genetic testing, and genetic testing does significantly serve to inform the clinician in treatment decisions with respect to evidence-based treatment of the patient's psychiatric disorders. Standard treatment is more trials that are less likely to be beneficial regarding risk for tolerability problems or lack of efficacy due to pharmacokinetic or pharmacodynamic factors. Genetic testing in this case identifies specific medications that are more likely to be impacted by these factors and more likely to be tolerated or efficacious. The testing also identifies a defect in the enzyme involved in folate synthesis which could indicate the need for supplemental treatment. Thus, it is reasonable, and in the patient's best interest to have genetic testing so that treatment going forward will be more likely to be beneficial and that future treatments will be provided with sound medical judgment in keeping with prevailing standards of medical practice and with the scientific literature and guidelines.