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

Diagnosis: Rheumatoid Arthritis
Treatment: Cimzia Kit
The insurer denied: Cimzia Kit
The denial is upheld

The patient is an adult female with longstanding deforming seropositive rheumatoid arthritis (RA). She failed treatment with Humira and Enbrel and remains on methotrexate 15 mg (milligrams) weekly and prednisone 10 mg (milligrams) daily. Per attached progress note from this month, she was improving on monthly intravenous Orencia, but because she remained prednisone dependent on Orencia, she was given a biologic "drug holiday". She is also being treated with an unclear biweekly subcutaneous injection (written as "calves" or "Cozaar", both of which are illogical for this scenario). The AP (attending provider) prescribed Cimzia and the patient was given a sample Cimzia dose at this visit. Cimzia was denied for this patient because she did not try or fail the Plan-preferred agents Rinvoq, Xeljanz and Kevzara. Per attached PA (Prior Authorization) request, this patient cannot self-inject biologic therapy due to her hand deformities. Appeal is for Cimzia for the treatment of RA (rheumatoid arthritis). 

The health plan should not cover the proposed Cimzia for the treatment of RA (rheumatoid arthritis) in this patient. 

This patient with seropositive RA (rheumatoid arthritis) failed treatment with Enbrel and Humira. Per attached documentation, she was doing well on Orencia monthly infusions, but remained prednisone dependent. She remains on methotrexate 15 mg (milligrams) weekly and prednisone 10 mg (milligrams) daily, and the AP (attending provider) started a sample of Cimzia at her visit this month. Per the AP (attending provider) appeal note, this patient cannot self-inject biologic therapy due to severe hand deformities. However, the Plan-preferred agents Rinvoq and Xeljanz are both oral targeted synthetic DMARDs (disease modifying anti-rheumatic drugs), so self-injection is irrelevant for these medications. The requested formulary drugs Rinvoq or Xeljanz would not be expected to be ineffective for this patient, nor have adverse effects for this patient. Rather, they would be expected to be more effective than the requested non-formulary Cimzia, as this patient has already failed treatment with two other TNF (tumor necrosis factor) inhibitors (i.e., Enbrel, Humira), and a third TNF (tumor necrosis factor) inhibitor such as Cimzia would likely be less efficacious than agents with an alternate 
mechanism of action. Switching to an alternate mechanism of action is in accordance with published 2021 American College of Rheumatology guidelines for the treatment of RA (rheumatoid arthritis). In addition, the requested Cimzia is a self-injected biologic therapy, as the PA (Prior Authorization) request specifically indicates that a Cimzia vial is not being requested. Thus, the request for non-formulary Cimzia is incongruous with the AP's (attending provider's) request to avoid self-injected biologic therapy. Therefore, the health plan should not cover the proposed Cimzia for the treatment of RA (rheumatoid arthritis) in this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: B-Cell Lymphoma
Treatment: CAR-T (chimeric antigen receptor T-cell) treatment
The insurer denied: CAR-T (chimeric antigen receptor T-cell) treatment
The denial is upheld.

The patient is an adult male. The patient in this case has relapsed CNS (central nervous system) lymphoma. His initial lymphoma was a skull base diffuse large B cell lymphoma. This was treated with RCHOP (Rituximab, Cyclophosphamide, Hydroxydaunomycin, Oncovin, Prednisone) for six cycles along with three cycles of high dose methotrexate. He had recurrence and was treated with RICE (Rituximab, Ifos-famide, Carbo-platin, Etopo-side) followed by autologous stem cell transplant. Now he has relapsed in the brain and is being treated with methotrexate, cytarabine and rituximab. CAR-T (chimeric antigen receptor T-cell) treatment is planned.

The requested health service is not medically necessary.

There is currently insufficient evidence to show that CAR-T (chimeric antigen receptor T-cell) treatment is clearly safe and effective for treatment of CNS (central nervous system) relapse of diffuse large B cell lymphoma. Available studies are small and do not clearly show the safety and efficacy of this treatment. Consensus guidelines do not endorse use of CAR-T (chimeric antigen receptor T-cell) treatment for this purpose. CAR-T (chimeric antigen receptor T-cell) therapy is not currently considered a standard treatment option in this setting and is not medically necessary.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #3:

Diagnosis:  Crohn's disease.
Treatment:  Stelara 90 milligram/milliliter (mg/ml) syringe every 4 weeks.

The insurer denied coverage for Stelara 90 milligram/milliliter (mg/ml) syringe every 4 weeks.  The denial is overturned.

The patient is a young adult with Crohn's ileitis. The patient was being treated with adalimumab (Humira) and then was switched to ustekinumab(Stelara). The patient was noted to have worsening symptoms on ustekinumab given every eight weeks, but his drug levels were not sufficiently high enough. Budesonide was started and other causes are being investigated to determine the cause of the patient's abdominal pain. Stelara level was 0.9.

In certain clinical scenarios, dose escalation to every four weeks can be beneficial.

Stelara 90 milligram/milliliter (mg/ml) syringe every 4 weeks does not have final approval from the appropriate regulatory bodies for this diagnosis. 

This patient is a good candidate for Stelara 90 milligram/milliliter (mg/ml) syringe every 4 weeks.

Stelara 90 milligram/milliliter (mg/ml) syringe every 4 weeks is the best available treatment for this patient at this time.

In this case the administration of ustekinumab (Stelara) every four weeks would be more beneficial than another agent.

In summary, the denial of Stelara 90 milligram/milliliter (mg/ml) syringe every 4 weeks
and coverage for the requested service/treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #1:

Diagnosis:  Crohn's disease.
Treatment:  Stelara 90 milligram/milliliter (mg/ml) syringe every 4 weeks.

The insurer denied coverage for Stelara 90 milligram/milliliter (mg/ml) syringe every 4 weeks.  The denial is overturned.

The patient has Crohn's disease.  He had a colonoscopy which showed active ileitis. He started on prednisone and then Humira. A repeat colonoscopy two years later still showed active ileitis. He started Stelara. He continued to have symptoms on the Stelara given every 8 weeks. He now has been advised to increase the Stelara to every 4 weeks. 

Clinical Gastroenterology and Hepatology 2021 Jan 19 (1): 104-110 has an article titled "Effectiveness of Ustekinumab (Stelara) Dose Escalation in Patients with Crohn's Disease." Data was studied from patients who initially received ustekinumab every 8 weeks and then had their interval shortened to every 4 weeks. The conclusion was that shortening the ustekinumab dose to every 4 weeks, in patients who did not respond to dosing every 8 weeks, improved clinical and biological indices of disease activity. It was noted that dose interval shortening was effective and safe. 

This patient has Crohn's disease that is not adequately controlled on the current Stelara dose. Dose escalation of Stelara is supported in the medical literature. The Food and Drug Administration (FDA) has approved a dosage of Stelara of 90 mg every 8 weeks. However, giving Stelara every 4 weeks has been shown to be both effective and safe. The patient is a good candidate for Stelara every 4 weeks since he has not responded adequately to the every 8 week dosing. Since he has already failed Humira, it is appropriate to try a higher dose of Stelara. It is likely to be more effective than continuing the Stelara every 8 weeks. 

In summary, the denial of Stelara 90 milligram/milliliter (mg/ml) syringe every 4 weeks
and coverage for this requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Major Depression Disorder.
Treatment: Vilazodone.
The insurer denied: Vilazodone.
The denial is overturned.

The case involves an adult male diagnosed with recurrent major depressive disorder. The patient's physician has prescribed vilazodone at the starting dose of 10 mg (milligrams) daily. 
The patient failed treatment with escitalopram, fluoxetine, and sertraline prior to the start of vilazodone. There are no reported symptoms of mania, formal thought disorder, psychosis, or severe cognitive impairment. The patient has no report of significant general medical conditions and no diagnosed substance use disorder. The prescribing physician is requesting coverage for Viibryd indicating that the patient has met the plan criteria for a coverage exception which requires a trial and treatment failure with at least three formulary alternatives. 
The health plan indicates that three formulary alternatives are required before a coverage exception for Viibryd would be approved. The treatment with Viibryd under review has been denied coverage by the health plan based on coverage exclusion, as alternative antidepressant medications are available under the plan's prior authorization criteria that requires step therapy; the plan requires treatment failure with at least three alternative formulary medications prior to authorizing a coverage exception for Viibryd (step therapy). The formulary alternatives include fluoxetine, sertraline, paroxetine, escitalopram, citalopram, and Trintellix. 

The health plan should cover the proposed treatment with vilazodone (Viibryd). 

The formulary drugs would be or has been ineffective for this patient as they are all SSRI (selective serotonin reuptake inhibitors) class antidepressants including failure with the required number of formulary alternatives which would lead to approval of vilazodone under the plan. 
The requested non-formulary drug has a unique mechanism of action that offers advantages in this patient who failed to benefit from three formulary alternative SSRI class antidepressants. 
Both formulary drugs and vilazodone would pose risk for adverse effects for this patient, and these can be managed with use of the lowest effective dose. 
Again, the denial of coverage for Vilazodone for the treatment of recurrent major depressive disorder is determined on the basis that three formulary alternatives are required for consideration of a coverage exception. Moreover, the prescribing clinician argues that plan criteria are met and that it is medically appropriate that a coverage exception be allowed as required under the plan. The appeal is reasonable in this case scenario and in the patient's best interest in keeping with prevailing standards of medical practice and the societal guidelines and scientific literature, referenced below.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hyperlipidemia.
Treatment: Nexletol 180mg (milligrams).
The insurer denied: Nexletol 180mg (milligrams).
The denial is upheld.

The patient is an adult female with a past medical history of hypertension and hyperlipidemia and a family history of coronary artery disease. Reportedly, she has tried multiple statins in the past, including rosuvastatin and simvastatin without adequate response and with evidence of transaminitis. She has also had a reported therapeutic failure to ezetimibe and Repatha. Consequently, Nexletol has been recommended for lipid lowering in this patient.

The requested Nexletol is not medically necessary.

Based on the provided documentation, there is no evidence that the patient has established ASCVD (atherosclerotic cardiovascular disease) or familial hypercholesterolemia confirmed by genetic testing. Therefore, there is insufficient clinical data to support medical necessity for use of Nexletol.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Small for gestation age (SGA)
Treatment: Pediatric Neonatal Intensive Care Unit (NICU) Admission
The insurer denied: Pediatric Neonatal Intensive Care Unit (NICU) Admission
The denial is overturned

The patient is a female infant born to an adult gravida one para zero t less than one (G1P0->1) mother with gestational diabetes treated with both insulin and metformin. All prenatal labs were negative (no glycated hemoglobin [HgbA1C] was reported). The pregnancy was further complicated by oligohydramnios. The mother developed pregnancy-induced hypertension treated with labetalol, that progressed to pre-eclampsia and operative delivery was indicated. The mother did not tolerate spinal anesthesia, so delivery was done under general anesthesia. 
There was active range of motion (AROM) at delivery. The infant's Apgar scores were 9 at one minute and 9 at five minutes. The infant's birthweight was 2240 grams. Due to maternal morbidities presenting risks to the infant, as well as low birthweight/small for gestational age, the infant was admitted to the neonatal intensive care unit (NICU) for further monitoring and cares. The infant's blood sugars remained in the normal range such that treatment for hypoglycemia was not needed. Feeds were started early and advanced without difficulty. The infant maintained her temperature in an open crib and was transferred to the Newborn Nursery on day #2.

The proposed treatment, Pediatric Intensive Care Unit (NICU) Admission, was medically necessary.

Per Recommended Best Cares for Small for Gestational Age (SGA) infants, additional monitoring of patient's adaptation to extrauterine life, specifically monitoring patient's temperatures, blood glucoses, respiratory pattern, and feeding ability are all indicated. Normal newborn nursery care typically does not provide this level of scrutiny, such that admission to a higher level of care was warranted. 
Gestational age is not the only predictor of an infant's ability to transition normally to extrauterine life. Birth weight, as well as other pertinent factors, must also be considered. The literature supports small for gestational age infants receiving additional monitoring in the first 24 to 48 hours of life to ensure that transition to extrauterine life is proceeding normally. Such monitoring is not provided in a "normal newborn nursery." Therefore, the infant's admission to/care in a neonatal care unit more skilled/advanced than the normal newborn nursery, where such close monitoring and interventions could be provided in a timely fashion, was medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Kidney Transplant.
Treatment: Valganciclovir.
The insurer denied Valganciclovir.
The determination is upheld.

This is a patient who underwent a living donor kidney transplant. The provider is requesting authorization for the use of Valganciclovir solution due to the patient's ongoing dysphagia. The cytomegalovirus (CMV) immunoglobulin G (IgG) status of the donor and recipient were not provided in the documents. This information was requested and received. At issue is the medical necessity of the requested Valganciclovir.

Based on the provided documentation the use of the requested Valganciclovir is not medically necessary.
CMV prophylaxis with Valganciclovir is recommended by national guidelines when either the donor or recipient are CMV IgG positive with the highest risk being a situation when the donor is IgG positive and the recipient is IgG negative at the time of transplant. CMV prophylaxis is not recommended if both the donor and recipient are IgA(Immunoglobulin A ) negative at this time of transplant. Neither the donor or recipient IgG status were provided in the documentation. In order for Valcyte to be medically necessary in this case the donor and recipient CMV IgG status would need to be provided. This information was requested and received.
The use of valcganciclovir is recommended and considered standard of practice after a kidney transplant in patients who have a higher risk for CMV infection.  These include recipients who are IgG positive of CMV at the time of transplant or recipients who receive an IgG CMV positive donor kidney regardless of the CMV IgG status of the recipient.  The patient in this case does not meet any of these criteria.  The patient in this case was IgG negative for CMV as was the donor kidney. In such a case where both recipient and donor are negative for CMV IgG, there is no clinical indication to use valganciclovir as the risk for CMV is considered to be too low to warrant therapy.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest Pain
Treatment: Inpatient Admission
The insurer denied: Inpatient Admission
The denial is: Upheld

The patient is a male who presented to the emergency department (ED) complaining of left-sided chest, scapular and shoulder pain that was exacerbated by movement of his left arm. He also reported chronic abdominal pain with a negative workup thus far. His medical history was remarkable for type 2 diabetes, hyperlipidemia and gout. In the ED his blood pressure was 119/73 millimeters of mercury (mmHg) with a heart rate of 68 beats/minute. His room air oxygen saturation was 100%. His left chest wall was tender to palpation. An electrocardiogram showed sinus rhythm and was a normal tracing. His serum troponin level was normal. The patient was treated with aspirin and admitted to the hospital. His serum troponin level remained normal. Myocardial perfusion imaging showed a defect that was thought to be artifactual due to diaphragmatic attenuation and was otherwise normal. An echocardiogram showed normal left ventricular systolic function. The patient was discharged. Medical necessity for an inpatient admission is at issue.

The health plan's determination is upheld.

An inpatient admission was not medically necessary. This patient presented with atypical symptoms that were thought to possibly represent acute coronary syndrome (ACS). Accordingly, monitoring until ACS could be ruled out was a reasonable approach. However, he was hemodynamically stable, with normal cardiac biomarkers, and a normal electrocardiogram. He did not require intensive monitoring or infusion of intravenous cardioactive medications. 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 cost-effective and is in accordance with current guidelines including the 2021 American Heart Association (AHA)/American College of Cardiology (ACC)/American Society of Echocardiography (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: Upheld

Diagnosis: Cellulitis
Treatment: Inpatient hospital admission
The insurer denied coverage for the inpatient hospital admission.
The denial is upheld.
 
Patient is an adult with past medical history significant for left leg hematoma, intravenous (IV) drug abuse, endocarditis, and permanent pacemaker placement who presented to the emergency room with complaints of swelling and redness of the left lower extremity.

Vitals on presentation included: temperature 36 degrees Celsius, blood pressure 135/89, pulse 94, respiratory rate 18, oxygen (O2) saturation 98% (percent) on room air. Laboratory values were notable for the following: white blood cell (WBC) count 12.7, hemoglobin (Hgb) 14.8, hematocrit (Hct) 46.8, creatinine 1.16, glucose 105.

The patient was empirically started on IV antibiotics (vancomycin) for left lower leg cellulitis. Ultrasound of the lower extremity showed soft tissue complex fluid collection in the anterior leg below the knee suspicious for a hematoma. Computed tomography (CT) scan of the leg confirmed 5.2 centimeter (cm) collection suggestive of a hematoma. Infectious Diseases and Vascular Surgery consulted. There was no indication for surgical intervention. Patient remained afebrile, hemodynamically stable and clinically improved. Patient was discharged to continue oral antibiotics (clindamycin) as an outpatient.

According to documentation, the patient presented with pain to left lower extremity after "bumping leg against hard object." Otherwise, patient remained afebrile, hemodynamically stable. Laboratory results were unremarkable except for a mildly elevated WBC count. Patient had no evidence of a disseminated infection, and no surgical intervention was deemed necessary. Imaging studies confirmed presence of a chronic hematoma consistent with her prior history. Based on above findings, patient did meet criteria for observation level of management. She did not fulfill criteria for acute hospital admission.

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

The medical necessity for the inpatient hospital admission is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Respiratory failure.
Treatment:  Inpatient stay.

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

The patient is a female with a history of end stage renal disease (ESRD) on hemodialysis, diabetes mellitus (DM), hypertension (HTN), asthma, prior deep vein thrombosis (DVT), depression, drug induced lupus, and subclavian vein stents who presented with generalized weakness and body aches. She had missed her last dialysis due to her acute illness. Her vitals showed a blood pressure of 220/110 but otherwise were unremarkable. On exam, she had bilateral rales and pitting edema. A chest x-ray showed cardiomegaly, bilateral hazy infiltration/congestion and two stents over left subclavian vessels. Her labs showed a creatinine of 7.13, influenza A+, a brain (or B-type) natriuretic peptide (BNP) &gt;70,000 and a troponin 0.217. An electrocardiogram (EKG) didn't show any ischemic changes but with a prolonged QTC of 520. The patient was placed on oxygen via nasal cannula. She was admitted for respiratory failure with hypoxia due to fluid overload and influenza A.

The inpatient admission was medically necessary based on the documentation provided. The patient presented with fatigue and malaise leading to her to miss her an outpatient dialysis session. On presentation, she had evidence of hypoxia and fluid overload. She was dialyzed for three consecutive days but continued to have documented hypoxia in the setting of an acute influenza illness. Her persistent hypoxic respiratory failure which persistent despite dialysis therapy necessitated an inpatient hospital stay and met the expectation of a greater than two midnight hospital stay. She could not have been safely managed at a lower level of care due to her continued oxygen requirement.