Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Upheld

 
Diagnosis: Transverse myelitis

Treatment: J1556-Bivigam

The insurer denied coverage for J1556-Bivigam

The denial is upheld 

Reviewer #1:

This is an adult with a history of cervical radiculopathy and diabetes. The patient has developed symptoms of transverse myelitis characterized by weakness of the lower extremities. The documentation states that the patient was tried on the following therapies including: Rituxan, steroids and plasmapheresis without improvement and that intravenous immunoglobulin (IVIG) should be given. 

Transverse myelitis is a general term for inflammation of both sides of one section of the spinal cord. This is a very nonspecific terminology of a process which affects both sides of the spinal cord. Etiologies could include autoimmune such conditions as multiple sclerosis (MS) or other conditions such as myelin oligodendrocyte glycoprotein (MOG) antibodies causing myelin oligodendrocyte glycoprotein antibody disease (MOGAD), or neuromyelitis optica with aquaporin-4 antibody (AQP4-ab) testing; other conditions could include infectious. 

Each of these diverse conditions which could lead the patient to developing transverse myelitis, have different specific treatments. In the case of multiple sclerosis, the patient should be placed on immunomodulation medications. In the case of infections, the patient is best served with the proper antibiotics. For rarer conditions such as myelin oligodendrocyte glycoprotein antibody disease (MOGAD), intravenous immunoglobulin (IVIG) in the literature retrospective studies suggests that intravenous immunoglobulin (IVIG) is helpful.

The review of the medical records does not document that the patient had any result of a magnetic resonance imaging (MRI) of the cervical spine with and without contrast, nor does it document that the patient has had a spinal tap to look for the etiology of the transverse myelitis. 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.

J1556-Bivigam does not have final approval from the appropriate regulatory bodies for this diagnosis.

Regarding whether the patient is a good candidate for J1556-Bivigam, there is not enough documentation to make the decision; therefore, the patient is not a good candidate. 

The adverse risks are not increased over standard treatment/services.

Based on the lack of documentation submitted in this case, (for example, no magnetic resonance imaging, labs or cerebral spinal fluid result), all that is known is that this is a patient with a diagnosis of transverse myelitis without any specific diagnosis that would indicate that a specific therapy should be undertaken. 

In summary, the denial of J1556-Bivigam should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks may not be substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Multiple Falls
Treatment:  Personal Care Aide (24 hours (hrs) per day, 7 days per week)
The insurer denied Personal Care Aide (24 hours (hrs) per day, 7 days per week). 
The determination is overturned.

This is a female patient with a medical history notable for multiple falls. The patient was approved for 8 hours per day, 7 days per week of personal care aide services. The patient and her care team requested and increase to 24-hour per day care, 7 days per week. The request was partially denied by the health plan; they did approve an increase to 10 hours per day, 7 days per week. The denial of 24-hour per day care is the subject under review.
The patient's physician provided a brief letter of support for this appeal. The letter states that the patient has had multiple falls over the past two to three months at which have resulted in hospitalization and a hip fracture. Her health is declining and the physician states that she requires additional help. Her gait is unstable. The physician recommends an increase in home health hours.
Overnight care logs were provided as part of this appeal. The logs demonstrate that the patient requires personal care assistance every two to three hours overnight for assistance with toileting.
A Uniform Assessment System (UAS) was completed. The assessment was conducted in person. The patient was alert and oriented but forgetful at times. She requires reminders for medications. She is able to call for help in case of an emergency. For instrumental activities of daily living, the patient requires total dependence for meal preparation, housework, and shopping. She requires maximal assistance for transportation, stairs, and finances. For her activities of daily living, the patient requires maximal assistance for bathing and stressing lower body. She requires extensive assistance for hygiene, dressing upper body, toilet transfer, and toilet use. She requires limited assistance for walking and locomotion. The patient was observed walking with an assistive device with unsteady gait. She requires assistance for transfers. She is frequently incontinent of urine and continent of stool. The assessment states there was no fall in the previous 90 days. At issue is the medical necessity of Personal Care Aide (24 hours (hrs) per day, 7 days per week). 
The requested health service of Personal Care Aide (24 hrs per day, 7 days per week) is medically necessary for this patient.
The patient requires personal care assistance for numerous activities of daily living including transfers, toileting, and ambulation. Her multiple recent falls while attempting to ambulate without assistance or evidence of unmet personal care needs. Because her care needs have been demonstrated to be continuous and unscheduled throughout the day and night, 24-hour personal care is medically necessary for the patient. Failure to provide for her personal care needs could result in additional falls and/or injury when attempting to complete personal care tasks independently.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Depression
Treatment: Inpatient hospital stay
The insurer denied the inpatient hospital stay.
The health plan's determination is overturned. 

The patient is a female with history of obsessive compulsive disorder, major depressive disorder, and newly diagnosed autism spectrum disorder. The patient was admitted with worsening intrusive thoughts and suicidal ideation. She is currently receiving electroconvulsive therapy. Under review is the continued inpatient hospitalization.

The inpatient hospital stay was medically necessary. While the patient has had a prolonged hospitalization, she continues to have significant distress. The patient's psychiatric symptoms impair her activities of daily living and she is unable to care for self without significant prompting. She has had severe side effects to medications in the past and thus has required electroconvulsive therapy, which is a treatment for treatment resistant depression. She continues to have suicidal ideation and cannot safely be treated at a lower level of care due to the severity of her symptoms.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obesity. 
Treatment: Stomach Surgery (CPT 43659) and Associated Postoperative Hospital Admission. 

The insurer denied Stomach Surgery (CPT 43659) and Associated Postoperative Hospital Admission. The health plan's determination is overturned. 

This patient is a woman under consideration for revisional bariatric surgery. The provider has proposed conversion of the sleeve gastrectomy to roux en Y gastric bypass as a tool to augment weight loss and treat comorbid health conditions. An inpatient level of care is also proposed. 

Based on the submitted clinical records and current peer-reviewed guidelines, the Stomach Surgery (CPT 43659) and Associated Postoperative Hospital Admission was medically necessary for this patient. The Current peer-reviewed guidelines support the performance of revisional surgery as is proposed in this case for a patient with a BMI (body mass index) in excess of 35 who has completed a comprehensive, multidisciplinary bariatric evaluation as is documented in this case. Given this patient's diagnosis, her current health condition, medical standards in the field of bariatric and metabolic surgery, the Stomach Surgery (CPT 43659) and Associated Postoperative Hospital Admission is medically necessary for this patient. This patient has a BMI in excess of 35 with weight related comorbid health conditions that include gastroesophageal reflux disease (GERD), back pain and hyperlipidemia. She has successfully completed a multidisciplinary bariatric evaluation. She has had appropriate presurgical counseling and has been cleared for bariatric surgery from a mental health standpoint. She has refractory medically complicated morbid obesity despite her participation with this program. The requested surgery and inpatient admission is indicated. The intensity of service associated with the management of the bariatric surgical patient (particularly a patient undergoing revisional bariatric surgery, as in this specific case) warrants an inpatient designation and is consistent with the standard of medical / surgical care. A 1-day period of inpatient confinement is consistent with bariatric surgical standards for this patient. A lower level of care such as observation, rather than inpatient care, could jeopardize the health of this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Infertility.
Treatment:  In vitro fertilization (IVF) - embryo transfer.
The insurer denied coverage for in vitro fertilization (IVF) - embryo transfer. 
 The denial is upheld. 

The patient is interested in conceiving. The patient has a diagnosis of age-related decrease in ovarian reserve. The request is for an IVF cycle frozen embryo transfer with donor eggs.

The insurer has denied coverage for in vitro fertilization (IVF) - embryo transfer, as not medically necessary. In a Final Adverse Determination letter, they stated that the patient does not meet guidelines for premature ovarian failure. The embryo transfer is denied based on the infertility policy.

It is important to understand that fertility declines as a woman ages due to the normal age-related decrease in the number of eggs that remain in her ovaries. This decline may take place much sooner than most women expect.

Fertility gradually declines in the 30s, particularly after age 35. Each month that she tries, a healthy, fertile 30-year-old woman has a 20% chance of getting pregnant. That means that for every 100 fertile 30-year-old women trying to get pregnant in 1 cycle, 20 will be successful and the other 80 will have to try again. By age 40, a woman's chance is less than 5% per cycle, so fewer than 5 out of every 100 women are expected to be successful each month. These percentages are true for natural conception as well as conception using fertility treatment, including in vitro fertilization (IVF). The age-related loss of female fertility happens because both the quality and the quantity of eggs gradually decline.

At this age, this patient does not have an illness or a disease that requires treatment: the patient has natural physiological inability to conceive due to natural aging; therefore, treatment including IVF with donor egg or frozen embryo transfer is not medically necessary. Every woman who reaches advanced age and has decreased ovarian reserve or menopause, even a 70-year-old, should be able to conceive with donor eggs. The question is when is infertility due to a pathological state or when is it a normal physiological development.

If a 25-year-old is unable to conceive because of premature ovarian failure or decreased ovarian reserve, this is obviously a pathological condition, and donor egg should be approved.  If a 49-year-old is unable to conceive, this is unfortunately considered "normal", and, therefore, in the absence of a medical condition, treatment is not indicated. Note that pregnancy with advanced maternal age is associated with relatively more complications and poorer outcomes.

In summary, IVF with donor eggs and embryo transfer is not medically necessary for this patient.

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

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for in vitro fertilization (IVF) - embryo transfer is not substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Thyroid cancer.
Treatment:  Tirosint (levothyroxine).

The insurer denied Tirosint (levothyroxine).  The health plan's determination is overturned. 

This is a female diagnosed with Malignant Neoplasm of Thyroid Gland; Graves' disease; Hypothyroidism; High Catecholamine Level in Urine. As per the information provided, she has had a total thyroidectomy and was found to have thyroid cancer. Since her surgery, she was on Synthroid-levothyroxine tablet. She was unable to achieve normal thyroid levels despite up-titrating the Synthroid dose multiple times. She has been on using Tirosint capsule samples and her thyroid levels started to improve. Tirosint (levothyroxine) is under review.

A formulary exception is indicated in this patient's case.

The formulary alternative has been ineffective for this patient. Tirosint is a brand name of levothyroxine. Levothyroxine capsules are a generic formulation for Tirosint. The patient is reported to have hypothyroidism. Tirosint is Food and Drug Administration (FDA) approved for the treatment of hypothyroidism.

The patient had failed Levothyroxine tablets. The patient is reported to have been unable to achieve normal thyroid levels despite titrating Levothyroxine. The patient has a history of thyroid cancer and has undergone thyroidectomy. The patient cannot afford having uncontrolled thyroid levels in this case. The use of Tirosint is indicated in this case and within the generally accepted standards of medical practice.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Constipation

Treatment: Motegrity 2 mg Tablet

Insurer denial of Formulary Exception for Motegrity 2 mg Tablet to treat constipation 

The denial is reversed.

The patient has a history of a gastric bypass and a cholecystectomy. She was diagnosed with chronic idiopathic constipation. She was initially given Linzess a few years ago.  A progress note stated that she was on Linzess but remained with constipation. An office visit has a medication record indicating that she was on Amitiza. Since she was not responding well to the Linzess, her physician has advised her to take Motegrity. 

UpToDate article titled "Management of chronic constipation in adults" discusses pharmacologic treatment. There are several choices of medications including linaclotide and plecanatide which are guanylate cyclase-C receptor agonists, lubiprostone which is a locally acting chloride channel activator, and prucalopride which is a 5HT 4 prokinetic agent. Prucalopride has been shown to be superior to placebo in clinical trials and was safe and well tolerated. Improvement in the quality-of-life scores was maintained up to 18 months. 

This patient has a diagnosis of chronic idiopathic constipation. The medical record documents that she has already tried the formulary alternatives of Linzess, and Amitiza. The formulary drugs did not cause any adverse reaction but were not effective. 

Motegrity is likely to be more effective since the patient has already tried and failed the formulary alternatives of Linzess, and Amitiza. 

The carrier's denial of Formulary Exception for Motegrity 2 mg Tablet to treat constipation is reversed.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dementia
Treatment: Increase in personal care assistance (PCA) level 2 to 84 hours/week (12 hours/day, 7 days/week)
The insurer denied the increase in PCA level 2 to 84 hours/week (12 hours/day, 7 days/week).
The denial is overturned.

The patient is an elderly female. Her medical history includes dementia, osteoarthritis, hypertension, hyperlipidemia, and depression. Denial of increase in personal care assistance (PCA) to 84 hours/week (12 hours/day, 7 days/week) is being appealed. The health plan approved an increase to 28 hours/week.

The patient's Uniform Assessment System (UAS) evaluation completed 3 months ago shows severely impaired cognition and functional status: total dependence with meal preparation and housework; maximal assistance with managing medications, shopping, bathing, lower body dressing, and toilet uses; extensive assistance with phone use, upper body dressing, walking, locomotion, and toilet transfer; and limited assistance with personal hygiene and bed mobility; and supervision with eating. She is unable to stand for prolonged periods and is a fall risk. She has frequent bladder incontinence.

A letter from the patient's daughter reports that the patient lives with her other daughter, but that that daughter has medical and mental challenges. A letter from the patient's provider reports that the request will assist in maximum functional capacity in performing activities of daily living (ADLs).

The requested increase in PCA level 2 to 84 hours/week (12 hours/day, 7 days/week) is medically necessary.

Personal assistance services provide hands-on assistance to individuals to include assistance with ADLs, health maintenance activities, and routine support services. Denial of increase in PCA to 84 hours/week (12 hours/day, 7 days/week) is being appealed. The health plan approved an increase to 28 hours/week. This patient has multiple chronic conditions. UAS evaluation completed 3 months ago shows the patient requires assistance with all ADLs, except eating. She has bladder incontinence. Appeal statements request additional hours to support physical functioning. The information provided shows that this patient has significant limitations in functioning. The approved PCA 28 hours/week is insufficient to meet this patient's needs for assistance with ADLs throughout the day. The requested increase to 84 hours/week is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: chest pain
Treatment: inpatient stay
The insurer denied the inpatient stay.
The health plan's determination is upheld. 

The patient is a male who presented to the emergency department (ED) with chest pain. The patient described his chest pain as constant, with no radiation. The patient also was complaining of nausea and vomiting for 2 days. The patient had bloody/dark emesis initially. The patient also was complaining of shortness of breath with exertion and cough. The patient mentioned that his last bowel movement (BM) was 3 days ago and he had BRBPR (bright red blood per rectum). The patient was seen previously and left against medical advice (AMA) with abdominal pain, back pain, dizziness and leg pain. The patient was admitted to the hospital. The impression was, right lower lobe (RLL) infiltrate pneumonia, possible aspiration, vomiting, chest pain, anemia, cirrhosis, and seizures.

The Inpatient Hospital Admission was not medically necessary for this patient. The patient presented with several complaints, and one was chest pain, however, his troponin and electrocardiogram (ECG) were normal and there was no follow up work up for this complaint. The patient did not have indications for inpatient admission for his chest pain.
The patient was diagnosed with pneumonia and was treated with antibiotics. His pneumonia was not associated with complications that would justify inpatient admission, such as respiratory distress, high fever, hemoptysis or others. His pneumonia could have been managed as outpatient.
The patient also presented with alcohol abuse. He was on Clinical Institute Withdrawal Assessment (CIWA) protocol, but there were no signs of withdrawal. The other medical problems, such as liver cirrhosis, seizures and others were present, but without manifestations or complications requiring inpatient admission. In summary, inpatient admission was not medically necessary. A lower level of care would have been more appropriate.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Class I Malocclusion
Treatment: D8080 braces, D8670 monthly visit
The insurer denied: D8080 braces, D8670 monthly visit
The denial is overturned.

This is an adolescent female patient requesting orthodontic benefits and monthly visits. The patient has a skeletal Class I malocclusion with Class II canines. She has severe upper and lower arch crowding. The prior denial was due to score of 23 points on the handicapping index scale.

The requested health service is medically necessary.

The patient has two of her anterior teeth (number (#) 22 and #27, lower left and right canines) in crossbite (reverse bite). These two things are both automatic qualifiers for benefits according to the handicapping index scale. Orthodontic treatment is needed to correct these problems, and the case has medical necessity. Monthly visits are needed to make sure the treatment is progressing properly. Therefore, the requested health service is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Esophagitis

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission

The denial is overturned

The patient had a history of a cardiomyopathy and a transient ischemic attack (TIA) and presented with being lightheaded and short of breath (SOB). The patient had come to the emergency room (ER) a couple of days earlier and was discharged. The patient reported having micturition syncope. The patient now also stated that they were having black tarry stools. The patient's home medications included aspirin and Plavix. The patient was afebrile and the vital signs were stable although orthostatic changes were found. The abdominal exam was benign. The hemoglobin dropped from 12.6 to 7.9 two days later. The international normalized ratio (INR) was 1.23. A chest computed tomography angiography (CTA) was negative. The patient was treated with Protonix. An endoscopy revealed esophagitis and a non-bleeding duodenal ulcer. The patient was transfused a unit of packed red blood cells (PRBC), and the hemoglobin went up to 8.4. Two days later, the patient was again noting dark stool. The patient was again found to have orthostatic hypotension. The Plavix was held and then restarted. 

Medical necessity was determined based on Milliman Care Guidelines (MCG) guideline M-180 for Upper Gastrointestinal Bleeding. Hemodynamic instability is an indication for admission. This is defined by the MCG guidelines to include orthostatic hypotension that persists despite appropriate treatment. 

This patient had orthostatic hypotension both in the ER and subsequently again on day 3 of the hospitalization. There was a large drop in the hemoglobin over a 2-day period. The patient was also on antiplatelet treatment with aspirin and Plavix. In view of the persistence of tarry stools with recurrent orthostatic hypotension, the patient met MCG criteria for admission. The denial is reversed.

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for the full hospital admission is substantiated.