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

Diagnosis: Pompe disease
Treatment: Nexviazyme
The insurer denied Nexviazyme. The health plan's determination is overturned. 

The patient is a female who is requesting continuation of treatment with Nexviazyme. The patient is diagnosed with Pompe disease. The drug was denied by the health plan because there was not documentation of disease stability or improvement. The provider appealed the determination. No formulary drugs were provided by the health plan.

The non-formulary drug is clinically appropriate for the patient's condition.
Nexviazyme is Food and Drug Administration (FDA) approved for long-term treatment of Pompe disease. The patient is diagnosed with Pompe disease as confirmed by muscle biopsy and molecular testing. Pompe disease (also known as acid-maltase disease and glycogen storage disease II) is a rare genetic disorder that causes progressive weakness to the heart and skeletal muscles. The drug was denied by the insurance plan because there was not documentation that the patient had improvement in her disease or stabilization of her disease; however, the records provided demonstrate that the patient has had stabilization of neuromuscular weakness without any decline in skeletal muscle or respiratory muscle function. As such, there is stabilization of the disease as the expected course is progressive neuromuscular weakness. Continued use of this drug is clinically appropriate for the patient's condition as the use is FDA approved and literature supported.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Syncope
Treatment: Inpatient admission
The insurer denied the inpatient stay.
The health plan's determination is upheld.

The patient is a male with a history of methamphetamine use, human immunodeficiency virus (HIV) and asthma, who presented with an episode of witnessed syncope. The patient passed out suddenly and it was associated with bowel and bladder incontinence. The syncopal episode was witnessed by his friend. The emergency medical services (EMS) were called and he was noted to be tremulous, tachycardic and had an oxygen saturation in low 90's. His labs showed a white blood cell count (WBC) 12, hemoglobin (Hgb) 16.7, serum creatinine (Cr) 1.52 and lactate dehydrogenase (LDH) was 2.29. His troponin was elevated at 0.3. His electrocardiogram (EKG) was non-ischemic. Cardiology evaluated the patient and recommended admission to rule out acute coronary syndrome (ACS) and for monitoring for arrhythmias. A computed tomography angiography (CTA) of his chest was obtained that showed no acute pulmonary embolism (PE). He was started on intravenous (IV) hydration and given IV Toradol and Tylenol. He was placed on telemetry monitoring. His orthostatic vital signs were monitored. His syncope was considered to be from dehydration and vasovagal phenomena. His computed tomography (CT) of his head was unremarkable. He was subsequently discharged home with a plan for the patient to follow up with his primary care physician (PCP).

The health plan in its determination of medical necessity acted reasonably, with sound medical judgment and in the best interest of the patient. The patient was admitted and placed on telemetry monitoring. He remained free of any arrhythmias and his troponins remained flat. He was able to eat and drink and his symptoms improved. He had mild acute kidney injury (AKI) that improved with IV hydration and he was subsequently discharged home. The patient did not meet criteria for inpatient admission. 

The patient had mild dehydration, vasovagal syncope and mild AKI. He had no difficulty in maintaining oral hydration. He was hemodynamically stable. The patient did not have sepsis, bacteremia or arrhythmias that would make him a candidate for an inpatient admission [1]. He had mild AKI, his serum Cr was only mildly elevated and his Cr was not greater than 4. He has no associated metabolic derangements, no severe electrolyte abnormalities, no associated moderate to severe infection or urinary obstruction that would make him a candidate for inpatient evaluation and management [2,3]. His history, EKG, age, risk factors, and troponin (HEART) score was low at 1 with 1-1.7 percent (%) risk of any major cardiac complications [4]. Such patients may be admitted to rule out ACS and for cardiac enzyme monitoring as in this patient but after flat troponins and no abnormality on the EKG, he was appropriate for discharge and outpatient follow up.
The care provided to the patient was appropriate for a lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Left Breast Cancer. 
Treatment: Proton Beam Therapy (PBT). 

The insurer denied: Proton Beam Therapy (PBT). 
The denial is overturned. 

The patient is an adult female with a diagnosis of cT1N1 left breast cancer status post neoadjuvant chemotherapy and left mastectomy and axillary nodal dissection.  Adjuvant chest wall and regional nodal radiation was recommended, and proton therapy was requested. 

The requested proton therapy is considered medically necessary. 

The request was initially denied by the health plan because it was considered not medically necessary per health plan criteria. 

In this case, the patient is an adult female with a diagnosis of cT1N1 left breast cancer status post neoadjuvant chemotherapy and left mastectomy with axillary nodal dissection.  Adjuvant left chest wall and regional nodal radiation was recommended and proton therapy was requested.  In this case, a dosimetric comparison with a photon-based plan was performed, and the proton therapy plan significantly reduces radiation dose to the heart and lung.  The mean heart dose was 9.6 gray (Gy) with photon therapy (which exceeded tolerance) and 0.5% with proton therapy (within tolerance).  The lung V5 dose was 96.7% with photon therapy (exceeded tolerance) and 42.4% with proton (within tolerance).  The lung V20 was 32.2% with photon therapy (exceeded tolerance) and 18.1% with proton therapy (within tolerance). 

A 2016 study from the University of Florida performed a comparative analysis and evaluated patients with breast cancer treated with proton therapy.  Median cardiac V5 was 0.6% with proton therapy (PT) and 16.3% with conventional radiation (P<.0001). Median ipsilateral lung V5 and V20 were improved with proton therapy (median V5 35.3% versus 60.5% [P<.0001]; and median V20, 21.6% versus 35.5% [P<.0001]).  The authors concluded that proton therapy "significantly improves cardiac dose, especially for left-sided patients, and lung V5 and V20 in all patients without excessive acute toxicity".   Proton beam radiation is the best technique for this patient that can provide adequate tumor coverage and normal tissue sparing and, in this case, it is a medically necessary treatment.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ehlers-Danlos Syndrome
Treatment: Aortic dysfunction or dilation genomic sequence analysis panel
The insurer denied: Aortic dysfunction or dilation genomic sequence analysis panel
The denial is: Upheld

The patient is a female with a history of fatigue, poor memory, difficulty concentration, chronic diarrhea, sweating abnormalities, autonomic neuropathy and joint hypermobility. The patient was evaluated by a clinical geneticist who found her features to be consistent with hypermobile Ehlers-Danlos syndrome (hEDS). The comprehensive Heritable Disorders of Connective Tissue (HDCT) gene panel was ordered at GeneDx. The subject under review is the medical necessity for the requested testing.

The health plan's determination is upheld.

The requested health service/treatment of Aortic dysfunction or dilation genomic sequence analysis panel is not medically necessary for this patient. According to the records, she does not have evidence of aortic dysfunction or family history of aortic dysfunction. She has a diagnosis of hEDS. There is currently no indication for genetic testing in hEDS patients because there is no known gene for hEDS and the yield is therefore extremely low. Testing of multiple genes not implicated in this specific type of Ehlers-Danlos syndrome (EDS), i.e., hEDS, can do more harm than good since there is a high risk of variants of uncertain significance (VUS) which would be difficult to interpret when many genes are ordered and most have nothing to do with the patient's clinical phenotype. This testing is indicated for 12 other types of EDS such as classical, vascular and arthrochalasia but the patient needs to meet clinical criteria for these types and the patient does not meet those criteria based on the records. HDCT also tests for Marfan and Marfan spectrum disorders, but the patient does not meet criteria for these disorders either according to the records.

Therefore, the requested testing is not indicated in this patient and is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Gastroenteritis.
Treatment:  Inpatient Hospital Services.

The insurer denied the Inpatient Hospital Services.  The denial is upheld.

The patient is a male with a past medical history significant for hypertension, fatty liver, and cataract surgery who presented to the emergency department with a history of nausea and multiple episodes of non-bilious, non-bloody vomiting and watery diarrhea. The patient also reported mild to moderate intermittent generalized abdominal cramping. He reported recent travel out of the country for 2 months. Upon initial evaluation in the emergency department, the patient underwent a computed tomography (CT) scan of the abdomen and pelvis, which was interpreted as a negative study for any acute intra-abdominal pathology. In the emergency department, the patient received 3 liters (L) of intravenous fluids and subsequently was continued on continuous intravenous fluids. He received symptomatic treatment with antiemetics for his nausea.

During the hospital stay, the patient's clinical condition significantly improved within the first 24 hours of the hospitalization. The acute kidney injury that was present at the time of admission resolved. The patient's creatinine came down to 1.11.

The patient was discharged from the hospital the next day after the day of admission.

The health plan's determination is upheld.

The inpatient hospital services were not medically necessary for this patient.

The patient presented to the hospital with symptoms of acute gastroenteritis, which was associated with volume depletion and acute kidney injury. The acute kidney injury was effectively treated within the first 24 hours of the hospitalization.

In general, based on the nationally accepted standards of care, admission at the acute inpatient level of care is usually indicated when a severe infection is suspected and associated with bloody diarrhea or an immunosuppressed state. Admission at the acute inpatient level of care is also suggested for patients with acute gastroenteritis who have severe abdominal pain, peritoneal signs, evidence of toxic megacolon, cases of hemodynamic instability, cases of severe or persistent vomiting, also in cases when dehydration is severe or persistent.

Another indication for hospitalization is electrolyte or metabolic abnormalities that are severe or persistent despite observation care. Initial indications for acute inpatient level of care include hemolytic uremic syndrome and inability to maintain oral hydration that persists after the emergency department and observation care treatment. In this clinical case, the patient had no circumstances listed above.

The dehydration was treated effectively within the first 24 hours of the hospitalization. The patient tolerated his meals and was discharged from the hospital the next day after admission.

The patient could have been managed at a lower level of care status.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Testicular hypofunction.
Treatment: Xyosted 75 mg(milligrams )/0.5 ml(milliliters).
The insurer denied Xyosted 75 mg/0.5 ml.
The determination is upheld.

This is a male patient diagnosed with testicular hypofunction. This request is for Xyosted 75 milligrams (mg) /0.5 milliliters subcutaneous (SC). The provider states he has a benign neoplasm of pituitary gland. He has tried and failed Androgel 1 percent (%) and a had low testosterone of 106. He was then prescribed testosterone cypionate but the patient was unable to self-inject. He has low testosterone levels despite being on all the treatments.
His hematocrit was 43.2; testosterone was 152 (range 264-916, median 590). At issue is the medical necessity of Xyosted.

The Xyosted is not medically necessary.

The American Association of Clinical Endocrinologists and the Endocrine Society recommendations require documentation of 2 low morning testosterone or free testosterone levels [1]. The diagnosis of hypogonadotropic or primary hypogonadism is made with a low testosterone, or free testosterone [2, 3]. The causes of acquired hypogonadotropic hypogonadism are the following: 1- structural (tumors, infiltrative lesions, infarction, head trauma), 2-functional (hyperprolactinemia, hypercortisolism, obesity, chronic systemic disease)[4]. Since the majority of causes involve abnormalities of the pituitary or hypothalamus, magnetic resonance imaging (MRI) is indicated to rule out structural lesions in these patients [2]. MRI is indicated in this group of patients when they are less than (<) 50 for all patients with a low testosterone and a normal luteinizing hormone (LH) or an elevated prolactin [5-8]. In older men, an MRI is indicated when there is a very low testosterone less than (<) 150 nanograms per deciliter (ng/dl) and a normal LH or an elevated prolactin or with visual changes or headaches. Obesity is a known cause of hypogonadotropic hypogonadism [5, 9, 10]. The diagnosis of hypogonadism is made using a low testosterone and an elevated LH and follicle-stimulating hormone (FSH) (primary) or low or normal LH (secondary)[9].
The Endocrine Society criteria recommend adjusting testosterone dosing to keep the testosterone level in the middle of the normal range. "We suggest aiming at achieving serum testosterone levels during treatment in the mid-normal range".
The Endocrine Society criteria also recommend that testosterone be adjusted with the patient's symptoms in mind.
The patient is reported to have hypogonadotropic hypogonadism with low testosterone levels. The pretreatment testosterone levels are not reported. However, the denial was based on the lack of trial of the formulary alternative Fortesta. Given that the patient was unable to self inject using testosterone cypionate it is preferable for the patient to use a gel formulation rather than another injectable formulation. The patient can try Fortesta. The request is therefore not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Glioblastoma multiforme.
Treatment: Xpovio.

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

The patient is a male diagnosed with glioblastoma multiforme who is currently undergoing therapy with radiation and Temodar. Treatment with Xpovio is the subject of this review. The drug was denied by the plan as not medically necessary. 

Xpovio is medically necessary.

The available evidence supports the use of Xpovio for treatment of glioblastoma. The available clinical evidence is from an open-label study, which showed that the drug demonstrated efficacy, with durable responses and disease stabilization in recurrent glioblastoma multiforme (GBM), and it was recommended for further development. In a phase II study for glioblastoma, the drug showed induced responses and also prolongation of progression free survival. As such, the use of this medication is a promising treatment strategy in addition to other first-line therapies, such as radiation and Temodar. The diagnosis of glioblastoma multiform has a dire prognosis, and nearly 95% of patients are dead at 5 years. This particularly therapy offers significant impacts in response and progression free survival on a difficult to treat cancer. It is medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbar Stenosis
Treatment: Lumbar Intraspinous Distraction Device
The insurer denied: Lumbar Intraspinous Distraction Device
The denial is: Overturn

The patient is a male who has low back pain with radiating pain to the bilateral hips and calf region, left greater than right. His pain is aching and burning. Pain level is rated at 6/10. Pain is increased with prolonged standing and walking. He is on Meloxicam 15 milligrams (mg) by mouth (PO) daily. He had tried extensive treatments including physical therapy (PT), lumbar transforaminal injections and radiofrequency ablation without adequate improvement. Physical exam (PE) was unremarkable except positive flip test. Lumbar magnetic resonance imaging (MRI) showed multilevel generative disc disease, moderate to severe on the left and mild to moderate right neuroforaminal stenosis at lumbar (L) 4/5, and severe bilateral L5/sacral (S)1 foraminal stenosis. This patient was recommended for Interspinous distraction device.

The proposed treatment is likely to be more beneficial for this patient than any standard treatment.
The interspinous distraction device can function as an extension blocker to minimize the extent of compression of neural elements, particularly in the lateral recess and foramina. There are clinical trials which demonstrated long-term clinical benefit of interspinous spacer decompression for lumbar spinal stenosis. Nunley's randomized controlled trial showed sustained clinical benefit for patients with intermittent neurogenic claudication associated with moderate lumbar spinal stenosis. (1) This patient has symptoms consistent with neurogenic claudication. MRI revealed foraminal stenosis at L4/5 and L5/S1 level. He is an appropriate candidate for the interspinous distraction device. The interspinous distraction device is a minimally invasive procedure that can be performed under monitored anesthesia with less surgical risks than open surgical decompression.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbar Stenosis
Treatment: Lumbar Intraspinous Distraction Device
The insurer denied: Lumbar Intraspinous Distraction Device
The denial is: Upheld

The patient is a male with lumbar spinal stenosis present for greater than one year. The patient has moderate to severe leg, and buttock symptoms. There is numbness and weakness in lower extremities. The patient's activities of daily living (ADLs) are restricted. The patient needs to sit and lean forward and can only walk moderate distances. The patient has tried and failed medications, physical therapy, as well as epidural injections and other low back injections. The pain is located in the low back and radiates into the buttocks. The pain ranges from a score of 5-10 out of 10. There is a plan for interspinous distraction device for lumbar spinal stenosis. This was denied by the health plan.

The proposed interspinous distraction device is not likely to be more beneficial than any standard treatment or treatments for the patient's condition. The patient has complaints of low back pain. There is a request for insertion of interlaminar and interspinous lumbar device. This device and procedure has not been proven to be medically effective and, is therefore, considered investigational for all indications, including treatment of neurogenic intermittent claudication due to spinal stenosis. A systematic review of 8 randomized controlled trials evaluating the efficacy of interspinous spacer devices for the treatment of neurogenic intermittent claudication due to spinal stenosis or low-grade degenerative spondylolisthesis found, at a follow-up range of 12-48 months, that as compared to nonoperative treatment, interspinous spacer devices were associated with improved pain and function scores and a lower rate of need for additional surgery; as compared to laminectomy, although there was no significant difference between the groups with regard to improvement in pain and function scores, interspinous spacer devices were associated with increased rate of reoperation; and as compared to laminectomy combined with instrumental spinal fusion, although interspinous spacer devices were associated with greater than (>) 25% improvement in leg and back pain and function scores, there was no significant difference between the groups with regard to reoperation rate. Additional studies were recommended. There is insufficient medical literature for the support of this procedure.
Given the above, the proposed health service or treatment interspinous distraction device is not likely to be more beneficial than any standard treatment or treatments for the patient's condition.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbar Stenosis
Treatment: Lumbar Intraspinous Distraction Device
The insurer denied: Lumbar Intraspinous Distraction Device
The denial is: Upheld

The patient is a male diagnosed with lumbar stenosis. The patient was recommended to undergo a lumbar interspinous distraction device at lumbar (L)4 - L5. Records indicate that this request was denied by the health plan as it is considered experimental and investigational.
Procedure reports were provided showing the patient underwent lumbar epidural steroid injections, cervical and lumbar facet radiofrequency ablations.
X-ray of the lumbar spine showed shallow dextroconvex lumbar lateral curvature with overall straining of the lumbar lordosis. Chronic appearing mild L2 and L3 superior endplate vertebral body compression fractures. Moderate multilevel thoracolumbar spondylosis with dominant degenerative disc changes at L5 - sacral (S)1.
Magnetic resonance imaging (MRI) of lumbar spine revealed multilevel degenerative disc disease. There is disc herniation at L5 - S1 and varying degrees of moderate to severe neural foraminal stenosis and canal stenosis as well as facet hypertrophy.
At the most recent progress report the patient was seen with complaints of chronic low back pain radiating to the hips and buttock rated at 7/10. It was noted the patient had more than six months of relief from lumbar radiofrequency ablation. The patient continued to have symptoms of neurogenic claudication throughout. The patient also had cervical radiofrequency ablations with good relief. Lumbar examination revealed positive facet loading with extension and twisting, low back pain with straight leg raise. Normal motor strength, sensation, and reflexes. The patient was recommended for repeat lumbar radiofrequency ablation and also recommended to undergo interspinous spacer implant targeting L4 - L5 for his neurogenic litigation. It was noted that dual energy X-ray absorptiometry (DEXA) scan showed no findings of osteoporosis.

There is no evidence that the proposed health service or treatment interspinous distraction device is likely to be more beneficial than any standard treatment or treatments for the patient's condition. The patient is noted to have chronic low back pain with imaging studies showing multilevel degenerative disc disease, disc herniation at L5 - S1 and varying degrees of moderate to severe neural foraminal stenosis and canal stenosis as well as facet hypertrophy. X-rays also showed mild L2 and L3 superior endplate vertebral body compression fractures. According to Official Disability Guidelines (ODG) by Milliman Care Guidelines (MCG), "Not recommended as a first-line treatment option; evidence shows inconclusive benefit, lack of benefit, or potential harm." 
There is no evidence to suggest that this proposed treatment is likely to be more beneficial than standard treatments for this patient's condition.