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

Diagnosis: Cystic Fibrosis (CF)

Treatment: Trikafta

The insurer denied coverage for Trikafta

The denial is upheld 

Patient is a with history of (H/O) Cystic Fibrosis.

Patient is presently on Ivacaftor for her CF. As per clinic notes the patient has had Pneumonia X 2 in the past month which required treatment with Oral and intravenous (IV) antibiotics (Abx). The patient's symptoms included wheezing, coughing and hemoptysis. Patient was also noted to have some decline in her lung functions
FVC (forced vital capacity) 2.22 68%
FEV (forced expiratory volume) 1 1.25 48%
FEV1/FVC ratio 56 %.

For patient's mutation Ivacaftor and Tezacaftor / Ivacaftor is also approved but the patient did not tolerate it.

The patient's medical doctor (MD) is requesting approval for Trikafta a combination of Elexacaftor, Tezacaftor and Ivacaftor.

This combination has not been approved by the FDA (food and drug administration) for the mutation that this patient has. There are no studies that have shown benefit of this product in patients with mutation that this patient has. The data is anecdotal.

Based on above Trikafta cannot be approved for this patient at this time.

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

The insurer's denial of coverage for Trikafta is upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Radial styloid tenosynovitis

Treatment: L3809-RT-KX, wrist hand finger orthosis, without joints, prefabricated, off the shelf, any type

The insurer denied coverage for L3809-RT-KX, wrist hand finger orthosis, without joints, prefabricated, off the shelf, any type

The denial is overturned

This is a male with right wrist pain and diagnosed with radial styloid tenosynovitis. He was seen for physical therapy and provided an L3809-RT-KX, wrist hand finger orthosis, without joints, prefabricated. 

According to the case notes, the insurer denied coverage for the requested orthosis due to lack of medical records including a detailing a history and physical examination. However, the therapy notes submitted for review are sufficient to support the medical necessity of the requested orthosis. A physical therapy note documents the patient's right wrist pain and difficulty performing activities of daily living. Another physical therapy note again documents his right wrist impairment, as well as detailed right upper extremity range of motion/manual muscle testing and response to treatment. From a physical medicine & rehabilitation/pain management perspective, the submitted physical therapy notes appropriately document the patient's right wrist/hand impairment and support the medical necessity of the right wrist orthosis.  

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

The insurer's denial of coverage for L3809-RT-KX, wrist hand finger orthosis, without joints, prefabricated, off the shelf, any type is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Menorrhagia
Treatment: Lo Loestrin Fe
The insurer denied Lo Loestrin Fe.
The determination is upheld.

The patient has menorrhagia and acne and she was prescribed Lo Loestrin Fe and this was denied by the health plan as not medically necessary as she must have tried and failed formulary alternatives such as: Norethidrone/Ethinyl estradiol/Iron 1/20, Norethidrone/Ethinyl estradiol/Iron 1.5/30, Levonorgesterel/Ethinyl estradiol 0.1/20 prior to the non-formulary medication. At issue is the medical necessity of Lo Loestrin Fe.

The requested health service/treatment of Lo Loestrin Fe is not medically necessary for this patient.
The patient has heavy, crampy menses and was prescribed the oral contraceptive LoLoestrin Fe for treatment. Combined oral contraceptives are an acceptable treatment for dysmenorrhea and menorrhagia; however, there is no medical necessity for this particular medication. All of the oral contraceptives are an acceptable treatment for her symptoms including the formulary medications: Norethidrone/Ethinyl estradiol/Iron 1/20, Norethidrone/Ethinyl estradiol/Iron 1.5/30, Levonorgesterel/Ethinyl estradiol 0.1/20. There is no documentation that the patient has tried formulary medications and failed them secondary to continued symptoms or side effects. She was only seen at her initial visit and has no follow up including an intolerance to alternative oral contraceptives. Therefore, LoLoestrin Fe is not medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: GERD (gastroesophageal reflux disease)
Treatment: LINX Procedure
The insurer denied the LINX Procedure.
The determination is upheld.

The patient has a body mass index (BMI) of 27 kilograms per square meter (kg/m2) with symptomatic gastroesophageal reflux disease (GERD) despite proton pump inhibitor (PPI) and histamine (H2) blocker intake. Esophageal manometry was obtained, which was normal. The patient had a 24 hour potential hydrogen (pH) study that revealed a severely elevated DeMeester score of 99.4 (normal less than [<] 14) consistent with GERD. An endoscopy performed revealed esophagitis without a hiatal hernia or evidence of Barrett's esophagus. There is no documentation of the prior esophagogastroduodenoscopy (EGD) report or pathology; however, the history reports prior documentation of Barrett's. The most recent EGD did not reveal any gross documentation of Barrett's; however, biopsies and pathology were not provided. At issue is whether the LINX procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The LINX procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. This patient has GERD refractory to medical management. Surgical treatment options that are considered standard today include laparoscopic Nissen fundoplication and LINX procedure. Both of these treatments have been shown in published studies to be more effective than medical management. LINX is comparable per mid-long-term studies to be as effective and durable as laparoscopic Nissen fundoplication with less risk of mortality and major morbidity. It has been recommended based on the available published literature to be a standard surgical treatment for GERD in nationally published guidelines from the Society for Gastrointestinal and Endoscopic Surgeons. The exclusions to LINX and Nissen fundoplication include BMI greater than (>) 35 kg/m2, in which case treatment of obesity is thought to be important for treatment of GERD. Other exclusions for LINX include Barrett's esophagus with dysplasia, age < 18, prior gastric or bariatric surgery, or hiatal hernia > 3 centimeters (cm). The LINX procedure is contraindicated in patient's with Barrett's esophagus with dysplasia and there is a relative contraindication with patient's with Barrett's esophagus as this expanded indication has not been fully studied in published studies as safe and effective. As a result, the requested procedure, although a standard treatment for GERD, is not medically necessary for this patient given the presence of this exclusion criteria. Although the provided EGD did not comment or biopsy for active Barrett's, prior history reports the presence of the disease from EGD report and pathology not provided.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Acquired coagulation factor deficiency, hypertension, unspecified convulsions, acute embolism and thrombosis, atrial fibrillation, malignant pleural effusion

Treatment admitted to personal care aide (PCA) level 2, 12 hours/day, 7 days per week, total of 84 hours per week

The insurer denied coverage for personal care aide (PCA) level 2, 12 hours/day, 7 days per week, total of 84 hours per week

The denial is overturned

This case involves a patient who has a history of acquired coagulation factor deficiency as well as hypertension, unspecified convulsions, acute embolism and thrombosis, atrial fibrillation, malignant pleural effusion, visual loss hyperlipidemia and benign prostatic hyperplasia.  The documentation indicated he has recently been admitted to hospice services and has been recommended to receive a personal care assistant.  

The documentation indicated he was admitted to hospice services and was noted to be bedbound.  He is incontinent and is legally blind.  The documentation detailed he has been receiving a personal care assistant for 4-1/2 hours a day 7 days a week.  He was seen with complaints of ongoing pain.  He was alert and oriented to person however he was very slow to process and forgetful.  He also had intermittent confusion.  The documentation indicated he needed assistance with bathing, dressing, grooming, toileting, and other activities of daily living.  The documentation indicated he was recommended he continue with the above services and increase hours of personal care aide availability 8 to 12 hours a day 7 days a week.

This individual has had multiplicity of medical issues that require personalized care assistance given the multiplicity of his issues.  He would, fit into the guidelines for personal care assistance. The health plan did not act reasonably in the best interest of the patient.

Based on the above, the medical necessity for the personal care aide (PCA) level 2, 12 hours/day, 7 days per week, total of 84 hours per week is substantiated. The insurer's denial is overturned.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Human Immunodeficiency Virus (HIV). 
Treatment:  Symtuza. 

The insurer denied Symtuza.  The denial is overturned in whole. 

The patient is a male with human immunodeficiency virus (HIV). His other medical history includes anxiety pending psychiatry evaluation, as well as asthma and back pain. He takes Symtuza with CD4 reported at 702 and HIV Viral load of 128 and 335. His treating provider request Symtuza to be continued, but the health plan requests consideration for formulary alternative drugs. The subject under review is whether the requested non-formulary drug is more effective than the alternative formulary medications.

The health plan's determination is overturned in whole. 

Even though from the formulary standpoint medications divided into separate pills could be effective, there is ample evidence on the medical literature about regimen simplification being a crucial element for improving adherence. Studies have assessed the impact of simplified one tablet regimens versus more complex regimens and results have shown that simplified regimens do result in improved adherence, compliance and even decreased hospitalizations and cost. This has been reproduced in multiple studies and therefore there is a preference for single tablet regimen use, when possible, in the HIV population.

In the case at hand the patient is described as having used the alternative of two separate tablets (Descovy+Prezcobix) and not reaching proper adherence and regimen was then simplified to single tablet. The patient is described as already attempting use of two separate alternatives with poor adherence. Regimen simplification will help with compliance and adherence.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cardiac/Circulatory Problems. 
Treatment: Inpatient Hospital. 
The insurer denied inpatient stay. 
The denial is upheld in whole.

The patient is a male who presented to the hospital complaining of two episodes of exertional chest pain. His medical history was remarkable for hypertension, hyperlipidemia, gastroesophageal reflux disease, hypothyroidism and chronic kidney disease. There were no acute electrocardiographic changes. His high sensitivity troponin level was 117 nanograms per liter (ng/L); repeat levels were 113 ng/L and 116 ng/L. The patient was admitted to the hospital. He was transferred to another facility for cardiac catheterization, which showed normal coronary arteries. The procedure was uncomplicated. The patient was discharged later the same day. Medical necessity for an inpatient admission is at issue.

The health plan's determination is upheld in whole.

Based on the documentation provided an inpatient level of care on was not medically necessary.
This patient presented to the first facility with symptoms that were thought to be suspicious for acute coronary syndrome (ACS). He had no acute ischemic electrocardiographic changes and, while his serum troponin levels were elevated, there was no significant delta troponin. Thus, these levels were not diagnostic of an acute myocardial infarction. At the time of transfer he had no chest pain and was hemodynamically stable. He did not require intensive monitoring or infusion of intravenous cardioactive medications. Coronary angiography showed normal coronary arteries and the procedure was uncomplicated. The care this patient received did not require an inpatient admission and could have been provided under a lower level of care status. This approach has been shown to be both safe and is in accordance with current guidelines including the 2021 American Heart Association (AHA)/American College of Cardiology (ACC) /ASE/American College of Chest Physicians CHEST /Society for Academic Emergency Medicine (SAEM)/Society of Cardiovascular Computed Tomography (SCCT)/Society for Cardiovascular Magnetic Resonance (SCMR) Guideline for the Evaluation and Diagnosis of Chest Pain and the 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Attention Deficit Hyperactivity Disorder (ADHD).
Treatment:  Vyvanase.

The insurer denied Vyvanase.  The health plan's determination is overturned. 

The patient is male child with medical history significant for attention deficit hyperactivity disorder (ADHD), with severe issues in school. He tried and failed methylphenidate and Adderall, having severe negative adverse effects with both (headaches, rashes, nausea). He was treated with methylphenidate, complicated by nausea and lack of efficacy. He continued with the medication with persistent nausea and lack of efficacy. He was transitioned to Adderall XR and took this medication. He experienced headaches and increase in ADHD symptoms while on this medication. He has been prescribed Vyvanse as the safest option with the lowest risk of side effects. He began a course of treatment with Vyvanse, with the family paying out of pocket. On Vyvanse, his ADHD symptoms significantly improved and he had no severe adverse effects.

Vyvanse 10 milligrams (mg) capsules are medically necessary and appropriate for treatment of this child's ADHD.

Attention-deficit disorder is thought to be the most common psychiatric disorder of school-age children, with an incidence of 3-7%. Although the cause is unknown, there are many theories under investigation involving brain anatomy and chemistry. Genetics and environmental factors may also play important roles. A person with ADHD may experience difficulties in many aspects of life including the processing of sensory information, and may also suffer from comorbid disorders such as autism, Tourette's, or other mental illnesses.

Stimulants are the most common medications used to treat children with ADHD. The mechanism of action involves release of dopamine and norepinephrine into the nervous system. The most common agent used in children is methylphenidate because of its efficacy and side effect profile. Lisdexamfetamine dimesylate (Vyvanse) is a long-acting amphetamine prodrug that has a long duration of effect, low intersubject and intrasubject variability, and minimal abuse potential. Vyvanse has been shown to be effective in children for long-term treatment of ADHD, although attention must be paid to growth rate and weight gain. This child has tried and failed treatment with methylphenidate and Adderall XR, with severe side effects and lack of efficacy. His ADHD symptoms have been well-managed on Vyvanse, and he has not experienced significant side effects. Continued use of Vyvanse is medically necessary and appropriate for this child.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Lower back pain

Treatment: Intracept procedure

The insurer denied coverage for Intracept procedure

The denial is upheld

This male has chronic low back pain and a diagnosis of lumbar stenosis. Magnetic resonance imaging (MRI) of the lumbar spine revealed multilevel degenerative disc disease along with moderate central canal stenosis at lumbar (L)4-5. He has Modic Type I changes at L4-L5 and L5-sacral (S)1. The patient has tried and failed physical therapy (PT), is currently taking Tramadol and Buprenorphine, and has implemented activity modifications.  The request is for RFA (radiofrequency ablation) of the Basivertebral nerves at L4, L5, and S1.

Fischgrund and colleagues (1) published a double-blind, sham-controlled RCT (randomized controlled trials) evaluating the Intracept system and RF (radiofrequency) ablation of the Basivertebral nerve for the treatment of chronic low back pain. A total of 225 participants with chronic (>= 6 months) isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham (n=78) or treatment (n=147) intervention. In the active treatment group, the RF probe was activated and the temperature at the tip was maintained at 85Celsius for 15 minutes. The duration of the session in the sham group was the same but the RF treatment was only simulated. Study participants had a minimum Owestry disability index (ODI) of 30 points (on 100 point scale) and a minimum VAS [visual analog scale] of 4 cm (centimeters) (10 cm scale). The primary efficacy endpoint was the comparative change in ODI from baseline to 3 months. Both intention-to-treat (ITT) and per protocol (PP) analysis were pre-planned. A total of 19 of 147 (13% [percent]) participants in the treatment group were excluded from the PP analysis; 16 for a targeting failure, 1 for procedural failure and 2 for protocol non-compliance. One participant in the sham group was excluded from the PP analysis and this was for protocol non-compliance.

Limitations of this study include the lack of a sham control and limited duration of follow-up. The Intracept procedure is an experimental/ investigational procedure. The publications to date have been company sponsored and had methodology flaws.  There is no published data on long term complication rates.  UptoDate has evaluated this procedure and concluded that it is still investigational.  There are other evidence- based interventions available to this patient.  This procedure is unlikely to be more beneficial than the standard approaches.

The carrier's denial of the Intracept procedure should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Lower back pain

Treatment: Intracept procedure

The insurer denied coverage for Intracept procedure

The denial is upheld

The patient has a history of lumbar stenosis. He had a telemedicine visit with the Pain Management physician's for the evaluation of chronic lower back pain. He had pain for a year. Magnetic resonance imaging (MRI) of the lumbar spine revealed multilevel degenerative disc disease along with moderate central canal stenosis at L (lumbar)4-5. The patient has tried and failed physical therapy (PT), pain medications, and activity modifications. The physician recommended the Intracept procedure to treat lower back pain. 

The Intracept procedure is "intraosseous ablation of the basivertebral nerve". It has been proposed to address low back pain identified by Mobic changes. The procedure is performed within the vertebral body. It has been proposed that pain relief is manifested by patients no longer require their narcotics. For one level of disc disease each vertebral body requires precise targeting. There are no National Organizations which provide guideline nor indications. The procedure is essentially a thermoablation performed within the vertebral body. 

There are several level 1 studies showing the benefit of this procedure up to two years after treatment compared to controls. However, all of these studies were either funded by the manufacturer and/or authored by consultants from the manufacturer. No high-quality study exists that does not have a significant conflict of interest with the manufacturer. 
The requested procedure is not likely to be more beneficial than any standard treatment/procedure; the adverse risks are not fully known.

The carrier's denial of the Intracept procedure should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Immunologic Disorders.
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Xeljanz. 
The denial is upheld.

The patient is a female with alopecia areata, over 40% hair loss on her scalp. The patient has tried and failed topical, intralesional, and oral steroids. The provider has recommended Xeljanz.
At issue is whether the proposed health service Xeljanz is likely to be more beneficial than any standard treatment.

The health plan's determination regarding the proposed health service or treatment is upheld in whole.

The proposed health service or treatment Xeljanz is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Xeljanz would not likely be more beneficial than any standard treatment for the management of this patient's condition. According to the U.S. Department of Health & Human Services, National Institutes of Health (NIH) and Genetic & Rare Diseases Information Center (GARD) (2017), "No therapy has been found to work for everyone who has alopecia universalis (AU) which makes managing AU challenging. Although multiple treatments have been explored, no therapy is currently approved by the United States Food and Drug Administration (FDA). Some promising therapies include: diphenylcyclopropenone (DPCP), squaric acid dibutylester (SADBE), photodynamic therapy, steroids, cyclosporine in combination with methylprednisolone (a steroid). There are several recent studies showing that a class of medication known as Janus kinase (JAK) inhibitors, which includes Tofacitinib and Ruxolitinib, are effective in alopecia areata, including AU."
At this time however, there is only one JAK inhibitor United States Food and Drug Administration (FDA) approved for alopecia areata (AA). There is insufficient evidence that Xeljanz would be more effective.
Therefore, the proposed health service or treatment Xeljanz is not likely to be more beneficial than any standard treatment or treatments for this patient.