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

Diagnosis: Atopic Dermatitis
Treatment: Dupixent 300 (milligrams) mg/2 (milliliters) ml injections (4 per month)
The insurer denied coverage for Dupixent 300 mg/2 ml injections (4 per month).
The denial is overturned.

The patient has a diagnosis of severe atopic dermatitis affecting 20% (percent) total body surface area (TBSA) with and immunoglobulin A (IgA). The patient has previously failed therapy with prednisone, tacrolimus, clobetasol, triamcinolone, and antihistamines. The patient has improved with every other week Dupixent, but still has flares. The request is for weekly Dupixent dosing to improve efficacy.  

Based on the current peer-reviewed literature, Dupixent weekly is medically necessary. The patient has tried and failed biweekly Dupixent. In 2019, Thibodeaux, et al published "A review of dupilumab in the treatment of atopic diseases" in which they demonstrated that weekly dosing of Dupixent had significant efficacy. (1) Beck, et al also have reported on the efficacy of weekly Dupixent in "Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis." (2) Therefore, it is appropriate, based on the patient's clinical findings and refractory disease, to approve weekly Dupixent in this patient.

The unique clinical circumstances to this particular individual that would make it medically necessary is that the patient is not currently controlled with biweekly Dupixent. Chronic use of oral steroids has detrimental side effects. Therefore, weekly Dupixent is warranted in this case.  

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

The medical necessity for Dupixent 300 milligrams (mg)/2 milliliters (ml) injections (4 per month) is substantiated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: gastroesophageal reflux disease (GERD)
Treatment: Sucralfate suspension 
The insurer denied Sucralfate suspension. 
The health plan's determination is upheld. 

The patient is a female with gastroesophageal reflux disease (GERD). Sucralfate suspension for the treatment of gastroesophageal reflux disease is being requested and is under review. 

A formulary exception is not indicated. There is no documentation that the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects in this case. American College of Gastroenterology guidelines for the treatment of gastroesophageal reflux disease (GERD) recommend sucralfate for the treatment of GERD only in pregnancy. Additionally, the provided information does not substantiate clinical circumstances supporting an exception to the formulary, to use sucralfate suspension rather than the formulary medication (sucralfate tablets). There is a lack of evidence to demonstrate that sucralfate suspension is safer or more effective than sucralfate tablets. Per the Prescriber's Digital Reference, the sucralfate tablet is scored and may be cut into two pieces for ease of administration. Additionally, per the references, for patients who cannot swallow halved sucralfate tablets, the solution form can be prepared just before administration by slowly dissolving a 1-gram tablet in 15 to 30 milliliters (mL) of water, and "Within 30 seconds the sucralfate will dissolve into a suspension on its own".
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Acute on chronic inflammatory demyelinating 
polyneuropathy
Treatment: Consumer Direct Personal Assistance Services 
(CDPAS) 6 Days x 15 Hours and 1 Day x 16 Hours, Total 106 Hours per Week
The insurer denied: Consumer Direct Personal Assistance Services (CDPAS) 6 Days x 15 Hours and 1 Day x 16 Hours, Total 106 Hours per Week
The denial is overturned.

The patient is an adult female. Based on the clinical information provided, the patient had a final adverse determination denial notice. The request was to have personal care assistant services for 6 days times 15 hours and 1 day times 16 hours. The letter of denial noted that the patient had family members that could assist in the care of this patient. The denial is being appealed.

The requested health service is medically necessary.

In this instance, this patient has acute on chronic inflammatory demyelinating polyneuropathy. The patient has significant weakness with frequent bowel/bladder incontinence. It was noted that the patient was noted to have a rash to the diaper area and was receiving treatment for this. In this instance, this particular inflammatory condition requires aggressive physical/occupational therapy for rehabilitation to prevent further deterioration in the clinical status. Given that the patient has significant weakness, fecal and urinary incontinence, she is at significant risk for decompensation from her current clinical state resulting in potential adverse clinical outcomes including acute inpatient hospitalization and even death. The utilization of the extra hours is therefore currently needed in order to prevent adverse clinical outcomes.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: hip pain
Treatment: Left Hip Arthroscopy with Labral Repair, Hip Debridement/Shaving Articular Cartilage, and Left Hip Arthroscopy with Femoroplasty
The insurer denied Left Hip Arthroscopy with Labral Repair, Hip Debridement/Shaving Articular Cartilage, and Left Hip Arthroscopy with Femoroplasty.
The health plan's determination is overturned. 

The patient is a male with a complaint of left hip pain. His pain had been present for one year. Ice and non-steroidal anti-inflammatory drugs (NSAIDs) had been attempted by the patient without relief of pain. Plain radiographs of the left hip were normal. The history and physical examination was concerning for an acetabular labral tear. The provider referred this patient for an magnetic resonance (MR) arthrogram of the left hip. This study confirmed a superior labral tear in the patient's left hip. The patient had a follow up visit and the magnetic resonance imaging (MRI) results were reviewed. The patient was referred for physical therapy of the left hip. A physical therapy note documented that the patient had motion and strength deficits in the affected left hip.

The requested left Hip Arthroscopy with Labral Repair, Hip Debridement/Shaving Articular Cartilage, and Left Hip Arthroscopy with Femoroplasty is medically necessary for this patient. The current, peer-reviewed literature, including a recent article published by Lee and colleagues in 2019 found that "The clinical and radiological long-term follow-up revealed that improvement after arthroscopic labral repair and osteoplasty for femoroacetabular impingement (FAI) were maintained in most cases without significant progression of arthritis. Anatomical recovery of the acetabular labrum was associated with the improvement of clinical symptoms." This article documented the excellent outcome of arthroscopic labral and osteoplasty surgery for patients with documented hip pathology. Thus, based upon this peer-reviewed research and the documentation in the provided medical records, the medical necessity of the proposed surgery in this case is established.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: abnormal uterine bleeding
Treatment: Myfembree
The insurer denied Myfembree
The health plan's determination is upheld. 

The patient is a female with abnormal uterine bleeding and clinical endometriosis (no surgery). She was taking "OCP (oral contraceptive pills)" but stopped secondary to weight gain. Her hemoglobin was reported to be 14; however, six months prior to treatment it was 6.6. A recent endometrial biopsy was negative. Depo Provera x3 injections improved the bleeding, but her bleeding became irregular. Her physician would like to utilize Myfembree for treatment.

A formulary exception is not indicated in this case. The formulary drug will not be as ineffective, would be as effective as the non-formulary drug, or would not have adverse effects as documented.

The plan requires 3 formulary alternatives including Danazol, Lupaneta, Orilissa or Synarel for treatment prior to Myfembree. No documentation has been provided to show that these medications have been utilized or provided unwanted side effects. Therefore, Myfembree is not indicated.

Myfembree is Food and Drug Administration (FDA) approved for the use of heavy menses secondary to uterine fibroids or moderate pain secondary to endometriosis. The patient has not history of uterine fibroids and no definitive endometriosis. Therefore, the use of Myfembree in this case would not be FDA approved. In addition, Depo Provera appears to be working as her hemoglobin has improved and bleeding while irregular, is less heavy.
Appeal type: Medical necessity
Decision: Overturned

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

The patient is a pregnant female, gravida-2 para-1, who presented to the emergency department at 9 weeks gestational age with nausea and vomiting. She reported nausea and vomiting the entire pregnancy, with four prior emergency department visits for the same issue. Her medical history was remarkable for marijuana use. She was admitted and received multiple antiemetics, intravenous (IV) fluid, and IV potassium (to address hypokalemia).

The inpatient hospital admission for this patient was medically necessary. Looking at objective data, this patient had a low serum potassium, which is a feature of frequent vomiting that requires intravenous (IV) correction in those unable to eat. Her potassium level nadir was 3.0 during early labs. Without being able to eat, correction of the above required IV supplementation with potassium runs and fluid. Additionally, the patient had not had success with outpatient oral medications for nausea, warranting IV medications. These were not measures appropriate in the outpatient setting, and therefore dictated inpatient management. Given the failure of outpatient management (to include a previous emergency department visit), and electrolyte abnormalities, the inpatient stay was medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obesity

Treatment: Mounjaro

The insurer denied coverage for Mounjaro

The denial is overturned.

 
This is an adult female diagnosed with insulin resistance. This request is for Mounjaro. As per letter, she has a history of obesity and polycystic ovary syndrome (PCOS). She originally weighed 260 pounds (lbs) and was able to get down to a weight of 214 lbs using the maximum dose of semaglutide 2.4 milligrams (mg) a week. The weight plateaued at this value, and she was then changed to Mounjaro which she has had a great deal success with as she lost 38 lbs on the Mounjaro. Her weight is now 176 lbs. She is on Mounjaro 10 mg. She is exercising. 

The health plan did not act reasonably with sound judgment in their denial as the patient failed other approved glucagon like peptide 1 (GLP1) drugs for weight loss.

The requested medication Mounjaro (Trizepatide) is Food and Drug Administration (FDA) approved for the treatment of adults with type 2 diabetes.  It is a GLP-1 and Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor agonist.  It has been shown in clinical trials to lead to improvement in glycated hemoglobin (A1c) as well as weight loss (1-3). Although the medication is only FDA approved for type II diabetes, it has been shown to be safe and effective in the treatment of obesity (4,5).
The patient has already failed to lose weight on other approved GLP1 drugs for weight loss. 
Therefore, the request for Mounjaro in this case is consistent with generally accepted standards of medical practice and is, therefore, medically necessary.

The health plan did not act reasonably with sound judgment in their denial as the patient failed other approved GLP1 drugs for weight loss.

Mounjaro is medically necessary for this patient.

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 Mounjaro is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest Pain

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission

The denial is upheld 

This is the case of a patient that presented to the hospital complaining of worsening dyspnea, productive cough and chest pain. Past medical history was significant for hypertension, atrial fibrillation, stroke coronary artery disease and aortic endograft placement.  On arrival to the hospital, vital signs were stable (blood pressure 153/93, Pulse 84).  Physical examination revealed an irregularly irregular pulse without other abnormality.  12 lead electrocardiogram (ECG) revealed atrial fibrillation with a controlled ventricular rate and no evidence of ischemic ST or T wave abnormalities. Serum blood testing revealed elevated troponin levels (0.034). The patient was admitted to telemetry for evaluation and treatment. The patient was monitored on telemetry and discharged the following day on medical therapy with outpatient follow up.

The health plan acted reasonably, with sound medical judgment and in the best interest of the patient.  Full hospital admission was not necessary for this patient that presented with chest pain.  The patient's pretest probability of coronary artery disease was intermediate (Reference 1).  Utilizing the HEART (History, ECG, Age, Risk Factors, Troponin) score the patient was considered intermediate risk (5 points) (Reference 2). Risk assessment of patients presenting with chest pain and no significant ST changes on ECG was reviewed by Hedayati et al (Reference 3).  Using the HEART score risk stratification schema, this patient would have an intermediate risk of major adverse cardiac events (defined as myocardial infarction (MI), need for percutaneous coronary intervention (PCI), need for coronary artery bypass grafting (CABG), or death) in the six weeks following presentation. These findings are concerning and warrant management and evaluation that includes serial troponin measurement, echocardiography and ischemia work up prior to discharge. However, numerous studies have demonstrated that work up can be performed in an observation unit without the need for hospital admission. Several investigators studied patients presenting to the hospital with chest pain and compared outcomes between those admitted to the hospital for short stay admissions and those that were placed in an observation unit at a lower level of care (References 4, 5). They found no significant difference in outcome at 30 days between the two groups.  Fernando Bellolio et al. noted that patients presenting with chest pain, that were managed in an observation unit, had similar 30-day myocardial infarction rates as those admitted to the hospital (Reference 5).  Admission to the hospital to treat an acute cardiac event was not medically necessary.  In conclusion, this patient could have been managed at a lower level of care.

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 the hospital admission is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: mobility issues
Treatment: home health care
The insurer denied Home Care / Personal Care HHC - Level 2 Personal Care Services, per 15 Minutes Increase to 56 Hours per week. 
The health plan's determination is upheld. 

This is a case review for a female with medical history notable for mobility issues, coronary artery disease, kidney failure, and type 2 diabetes. A Uniform Assessment System (UAS) was completed. The assessment was conducted in person. The patient lives alone in a two-bedroom apartment. She reported a fall one week prior with no injuries. The patient was alert and oriented; she was able to direct her own care and make her needs known. She can call for help in an emergency. For her instrumental activities of daily living (IADL), the patient requires total dependence for housework. She requires maximal assistance for meal preparation and shopping. She requires extensive assistance for transportation. For activities of daily living, that patient requires extensive assistance for bathing and dressing lower body. She requires limited assistance for dressing upper body, walking, locomotion, toilet transfer, and toilet use. She is independent for all other activities. 

The requested Home Care / Personal Care HHC - Level 2 Personal Care Services, per 15 Minutes Increase to 56 Hours per Week is not medically necessary for this patient.

The patient requires assistance with instrumental activities of daily living and some activities of daily living. She is receiving 30 hours per week, which is nearly double the recommendation of the task tool. There is no documentation regarding which personal care services, if any, are not being met with the current allotment of personal care hours. Therefore, the requested increase in personal care hours is not medically necessary for the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Insulin resistance, metabolic syndrome and prediabetes
Treatment: Mounjaro 5mg (milligrams)/0.5ml (milliliter) pen injector
The insurer denied: Mounjaro 5mg (milligrams)/0.5ml (milliliter) pen injector
The denial is upheld.

The patient is an adult female diagnosed with pre-diabetes. This request is for Mounjaro. The patient notes that she is diagnosed with insulin resistance; metabolic syndrome; and prediabetes 15 years ago. She tried metformin and Glipizide for one year, along with diet and exercise changes and had minimal improvement. In 2010 she tried Topamax, but experienced extreme depression. She tried Trulicity 13 years ago but she had nausea and diarrhea. She also has recurrent UTI (urinary tract infection). Eleven years ago, she started Victoza but ceased after one year due to concern over lab results, which showed a negative impact on her pancreas. She has OCD (obsessive-compulsive disorder). She started on Mounjaro, and her BMI (body mass index) decreased from 40.6 to 39.2. Overall, she is doing well on Mounjaro.

The requested Mounjaro is not medically necessary.

The requested medication Mounjaro (Trizepatide) is FDA (United States Food and Drug Administration) approved for the treatment of adults with type 2 diabetes. It is a GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) receptor agonist. It has been shown in clinical trials to lead to improvement in hemoglobin A1c (glycated hemoglobin) as well as weight loss (1-3).
The patient is diagnosed with insulin resistance, metabolic syndrome and prediabetes. There are no studies showing the safety and efficacy of treating insulin resistance, metabolic syndrome and pre-diabetes with the requested medication. The request is not consistent with generally accepted standards of medical practice and is therefore not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Inflammatory bowel disease
Treatment: Jakafi
The insurer denied Jakafi. 
The health plan's determination is overturned.

This is a male patient with a history of very early-onset inflammatory bowel disease and immune dysregulation. He has tried and failed numerous therapies. He responded well to Jakafi. The requested service is Jakafi.
The use of Jakafi in this case is appropriate and medically necessary.
Inflammatory bowel disease (IBD) in some children can be a clinical manifestation of various primary immunodeficiency syndromes. Poor clinical outcome is often associated with poor quality of life and high morbidity from the complications of prolonged immunosuppressive treatment and malabsorption. This patient has a rare type of immune dysregulation causing severe bowel inflammation. This is not typical Crohn's disease or ulcerative colitis.
There are no standard therapies for this rare type of inflammatory bowel disease. Given the complexity of immune dysregulation associated with this condition, targeted immune therapies are often needed and are guided by the specific abnormalities seen during the immunologic evaluation.
According to the records, this patient has severe immune dysregulation leading to aggressive inflammatory bowel disease. The referenced literature supports treating similar immune dysregulations with Jakafi.
This patient has already tried and failed all the standard therapies. His condition is rare and not well studied. The clinical practice guidelines do not address this sub-type of immune dysregulation; therefore, there is no standard treatment for this kind of disease.
The only available alternative is a bone marrow transplant, which is a complicated treatment and can be associated with profound immune suppression and a high risk of mortality.
Given the lack of more appropriate alternatives and the excellent response to Jakafi, approval is recommended.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Transverse myelitis

Treatment: J1556-Bivigam

The insurer denied coverage for J1556-Bivigam

The denial is upheld 

Reviewer #3:

The medical records indicate this adult patient has transverse myelopathy and was treated with immune suppressant therapy. The patient was left with bilateral leg weakness and spasticity. The patient has also underwent cervical surgery for spondylosis with myelopathy. Per the provider, the patient was treated with plasma exchange and bevacizumab. The request for approval of Bivigam is the topic of this review.

According to the Food and Drug Administration (FDA) Prescribing Label For BIVIGAM, "BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of primary humoral immunodeficiency (PI)."

"Intravenous immunoglobulin (IVIG) is used in the treatment of autoimmune diseases, including immune-mediated central and peripheral nervous system disorders ... IVIG may have more than one mechanism of action to alter the pathogenesis of underlying neuromuscular disease. IVIg treatment has been used as a first-line treatment in Guillain-Barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, multifocal motor neuropathy, and second-line off-label treatment in medically refractory cases of polymyositis, dermatomyositis, and myasthenia gravis. IVIG is a well-tolerated and effective treatment for these neuromuscular diseases" (Burakgazi, A. Z. 2019).    

"The standard of care and the first-line therapy for the treatment of transverse myelitis is intravenous glucocorticoids. High-dose intravenous glucocorticoids should be initiated as soon as possible. There should not be a delay in treatment while waiting for test results. There are few contraindications to glucocorticoid therapy. Potential regimens would include methylprednisolone or dexamethasone for 3 to 5 days. Further duration of therapy should be directed as the clinical case progresses" (Simone, C. G., & Emmady, P. D. 2022).     

Based on the records provided, the patient is not diagnosed with Multiple Sclerosis (MS) or Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and there is no documentation of active ongoing demyelination. Intravenous immunoglobulin (IVIG) is not indicated for a single incident of Transverse Myelitis, which occurred seven (7) years ago, when there is no evidence of active disease. 

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

The patient is not a good candidate for J1556-Bivigam.

J1556-Bivigam is not the best available treatment for this patient at this time.
  
The adverse risks are increased over standard treatment/services.

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 be increased over standard treatments.