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

Diagnosis: Crohn's disease 
Treatment: Stelara every four weeks

The Stelara 90MG/ML SC SOSY every four weeks is not medically necessary.

The patient is a female who has Crohn's disease. She is currently using Stelara every eight weeks. The provider notes that she is a fast metabolizer of this medication, and as such he has requested its provision every four weeks. The provider notes she is currently having a good response to the Stelara at the current eight week dosing.

A review of the literature indicates that there have been no significant studies to date demonstrating the safety and efficacy of Stelara dose escalation to every four weeks in Crohn's disease other than anecdotal reports ,e.g. as follows:

Per Greenup A. et al, in the absence of therapeutic drug monitoring, empirical dose escalation has been considered as a strategy to optimize response in patients with either primary or secondary non-response. Efficacy and safety of UST (ustekinumab) 90mg subcutaneous (SC) every four weeks is not known.

A retrospective, observational study of compassionate use of UST in CD (Crohn's disease) was conducted at a Canadian tertiary center.

Results indicate that real-life experience of UST use in patients with CD, maintenance dose escalation to 90mg every four weeks had a modest benefit in achieving a clinical response. This may be suggestive of the mechanism of loss of response to UST being driven by factors other than low bioavailability due to processes such as rapid clearance. Further assessment in larger cohorts as well as the use of therapeutic drug monitoring will be important to evaluate the usefulness of dose escalation for patients on UST.

Reports such as the above are anecdotal and involve small numbers of patients. Therefore the usefulness, efficacy and safety of dose escalation of Stelara in patients with refractory Crohn's disease requires further study and would not be considered medically necessary.

Despite the patient's presentation and history, there are no cogent medical literature or society guidelines to recommend dosing Stelara at an interval of every four weeks for maintenance. There is no medical literature to show that this dosing frequency has a positive effect on healthcare outcomes. The formulary medications, including Stelara at a dosing of every eight weeks for maintenance, is as effective and without more adverse side effects than the requested non-formulary medication.

Jauregui-Amezaga et. al., Danese, and Simon, et. al. all note the use of Stelara in the management of Crohn's; however, there is no notation or support of use every 4 weeks for maintenance dosing.
Appeal type: Medical necessity
Decision: Upheld

This is a patient with a history of chronic anemia, hypertension and asthma who was referred by his gastroenterologist due to elevated liver function tests performed on an outpatient basis. Lab results at the hospital demonstrated a potassium of 3.2, bicarbonate 30, creatinine 1.5, alkaline phosphatase 189, alanine aminotransferase (ALT) 393, aspartate aminotransferase (AST) 508, and bilirubin 2.2 white blood cell count 5.5, hemoglobin 7.9, and platelets 743. A computed tomography scan of the abdomen/pelvis demonstrated a likely nonobstructing renal calculus and possible mild intrahepatic biliary dilatation. Intravenous fluids were provided. An abdominal ultrasound demonstrated no abnormal finding. The creatinine dropped to 1.3. Magnetic resonance cholangiopancreatography demonstrated no abnormality. The health plan's determination is upheld.

The patient had elevated liver function tests but was asymptomatic. There was no evidence of acute hepatic failure. Radiographic imaging studies including a computed tomography of the abdomen/pelvis, magnetic resonance cholangiopancreatography, and abdominal ultrasound showed no abnormal findings. There was no evidence of acute alcoholic or viral hepatitis. The patient remained afebrile and hemodynamically stable. Renal function improved promptly with hydration. There was no evidence of hepatic, splenic, or portal vein occlusion or thrombosis, ascites, or gastrointestinal bleed. Liver function tests improved during the hospital stay compared with those obtained on an outpatient basis.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cerebral palsy, developmental delay, tracheal brockomalacia
Treatment: E0483 x 3 - High frequency chest compression device
The E0483 x 3 - High frequency chest compression device is medically necessary.

The patient is a male with cerebral palsy, developmental delay, tracheal bronchomalacia, status post Nissen fundoplication with G-tube, ineffective cough, at risk for aspiration.

The vest is FDA-approved for providing chest physical therapy to patients with ineffective cough. Manual chest physical therapy or using a percussor puts patient at risk for aspiration due to required positioning.

The patient cannot use a PEP (positive expiratory pressure) device due to MRCP (mental retardation with cerebral palsy).

While the Vest is a safe and effective method of providing chest physical therapy it is not superior to other forms of providing chest physical therapy. However, the vest is the only method of providing chest physical therapy for this patient that does not put him at risk for aspiration.

The patient has ineffective cough and is at risk of aspiration, atelectasis and pneumonia. He requires daily chest physical therapy. The Vest is the only method of providing chest physical therapy for this patient that does not put the patient at risk for aspiration.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Seizure
Issue under review: Inpatient admission

Determination:
The Inpatient admission was not medically necessary.

The patient is an elderly male with a history of seizure disorder. He presented after having had a witnessed seizure at home. At presentation, he was noted to be alert and oriented, and he reported that he was non-compliant with his seizure medication. CT head was negative for acute intracranial pathology. 

The patient had a pre-existing diagnosis of seizure disorder and reported non-compliance with treatment. He was at baseline at presentation, and diagnostic testing was not required. The treatment, monitoring and evaluation could have been safely and effectively provided at a lower level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Right lower quadrant pain
Treatment: Inpatient admission
The Inpatient admission was not medically necessary. While the care as provided was medically appropriate, the level at which this car was rendered was not medically necessary as explained below.

The patient is a male. He presented to the emergency department of the facility requesting the appeal with the complaints of right lower quadrant pain. The pain started the day prior to presentation. The intensity was 7 out of 10. There was emesis after eating. The patient reported chills. The patient also had a history of Crohn's disease. The patient had been maintained on Entyvio every two months. 

On examination, the patient had pain on the right side of his abdomen. The patient had a hemoglobin level of 11.6. A CT scan showed a 2.4 cm x 0.6 cm rim enhancing fluid collection with inflammatory changes in the right lower quadrant and 1.1 cm x 0.7 cm abscess in the right lower rectal wall. The abdominal MRI performed showed a hemangioma and hepatosplenomegaly. 

The patient was admitted for an exacerbation of Crohn's disease, and he received supportive care and IV antibiotics.  The patient was seen in consultation by colorectal surgery, gastroenterology, interventional radiology and infectious disease specialists. The patient improved and was discharged. 

Despite the patient's presentation, the care as provided could have been rendered in its entirety at a lower level of care. The patient had an infection; yet he did not evidence a change in mental status, high fevers, neurologic changes, hypotension, signs of sepsis, hemodynamic changes, renal abnormalities, need for NPO (nothing by mouth) status, need for invasive surgery, need for invasive monitoring or treatments, severe electrolyte dyscrasias or any other indication for an acute admission.  As such the care could have been rendered at a lesser level.
Appeal type: Medical necessity
Decision: Overturned

Endocrine/Metabolic/Nutritional
Pharmacy/Prescription Drugs

The patient is a female with history of type 2 diabetes and cerebrovascular accident. Under review is Trulicity 1.5MG/0.5 ML pen. The medication was denied. The medication was denied because the patient did not meet medical necessity criteria under the health plan, specifically because the patient has not tried and failed the plan preferred GLP1 agonist Bydureon.

The health plan's determination is overturned. Trulicity is medically necessary for this patient. There are few head to head quality controlled trials comparing efficacy of different GLP1 agonists, however, generally as a class they have similar efficacy in glycemic control, with monotherapy Victoza and Bydureon lowering A1c by about 1.2%, with dulaglutide and semaglutide lowering up to 1.6-7% and Byetta and Lixisenatide lowering A1c mildly less than 1% (Feingold et al. 2019). The American Diabetes Association (ADA) / EASD (European Association for the Study of Diabetes) 2018 and the American Association of Clinical Endocrinologists (AACE) 2019 diabetes type 2 management guidelines do not differentiate between different types of GLP1 agonists in terms of glycemic-lowering efficacy. However, Trulicity and Bydureon differ in their profiles for reducing cardiovascular event risk.
In 2020 the Food and Drug Administration (FDA) approved Trulicity (dulaglutide) for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes with established cardiovascular disease or multiple cardiovascular risk factors. This approval comes after the results of the REWIND trial (Gerstein et al. 2018) - a randomized, controlled trial of 9,901 type 2 diabetes patients with either cardiovascular risk factors or established cardiovascular disease. Trulicity was shown to decrease first occurrence of major adverse cardiac events (MACE) (including non-fatal myocardial infarction, non-fatal stroke, and death from cardiovascular causes) and decreased incidence of various cardiovascular secondary outcomes.
Bydureon, unfortunately was not shown to have similar cardiovascular protective effects. In a randomized controlled trial of 14,752 type 2 diabetes patients, with or without previous cardiovascular disease, use of Bydureon 2 milligrams (mg) weekly was not associate with decreased incidence of major adverse cardiovascular events (Holman et a. 2017).
Because the provider is not only requesting a GLP1 agonist for A1c reduction, but also cardiovascular risk reduction, Trulicity (or a similar GLP1 agonist with such properties) is medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

This is a pregnant patient at 24 weeks 5 days gestation who had a cerclage placement secondary to cervical incompetence. She presented to the emergency room secondary to abdominal pain with nausea. A pelvic ultrasound showed a 1 centimeter (cm) cervical length and funneling. She was admitted to the hospital for possible preterm labor. Steroids for fetal lung maturity were provided and magnesium was started for contractions. She was discharged the following day in stable condition. At issue is the medical necessity of the inpatient hospital admission. 

The health plan's determination is upheld. 

She could have been monitored at a lower level of care than inpatient. None of the care required inpatient hospital admission and she was discharged less than 24 hours after admission. In addition, her vital signs were stable and she had no instability noted. She did not deliver and had no significant morbidity. She had no rupture of membranes, hemorrhage nor infection. Fetal signs were reassuring. If preterm labor was suspected and steroids with magnesium were required, they could have been performed at a lower level of care without inpatient hospital admission. Therefore, she could have been treated at a lower level of care, without inpatient admission.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Complication Of Heart Transplant And Heart
Transplant Rejection
Treatment: Everolimus
The treatment with Everolimus is medically necessary.

The patient is a male that underwent heart transplantation for the treatment of familial dilated cardiomyopathy a few years ago.  He presents now with cellular and antibody mediated rejection after a viral infection.  He required treatment with ATG (anti-thymocyte globulin), steroids, Plasmapheresis, rituximab and immunoglobulin.  The treating team started Everolimus as part of the immunosuppression protocol.

This patient suffered a rejection episode that was treated for cellular and antibody mediated rejection, requiring intense therapy with ATG, steroids, plasmapheresis, rituximab and immunoglobulin.  The need for Everolimus is due to multiple reasons:  renal protective after many years of exposure to cyclosporin, prevention of coronary arteriosclerosis by preventing fibrosis and decreased incidence of rejection compared to mycophenolic mofetil.  With the prolonged half-life, it can be a once a day medication with increased compliance with drug adherence.  

The indications for the use of Everolimus in organ transplantation have expanded over the last years, demonstrating an important agent in the modern immunosuppression protocols due to the selective mechanism of action, blocking the stimulation pathway and preventing cell activation.  There is an element of renal protection by potentiating the effect of cyclosporin and being able to decrease the dose of cyclosporin producing decrease in renal toxicity.  It also has an important effect of decreasing fibrosis and chronic graft injury as antifibrotic and antiproliferative agent.  These publications cited below are demonstrating the important role that Everolimus has developed in the immunosuppression protocols for solid organ transplantation.  There is evidence of improved graft survival and decreased rejection with the use of Everolimus when compared to mycophenolate mofetil.
Appeal type: Medical necessity
Decision: Upheld

Infectious Disease
Inpatient Hospital

This is a patient who was 5 weeks postpartum when she presented to the hospital with a chief complaint of right breast pain and swelling for the last 2 weeks that persisted despite massage and using hot compresses and was associated with chills.
On presentation, the patient was febrile to 100.7 degrees Fahrenheit with a heart rate (HR) of 144, blood pressure 116/78 and oxygen saturation of 99% on room air. Her exam was otherwise notable for the right breast being swollen, firm and having widening and flattening of the nipple. Lab results noted a white blood cell count (WBC) of 19, hemoglobin 9.5, platelets 546, comprehensive metabolic panel that was unremarkable, and lactic acid that was normal.
An ultrasound of the breast showed diffuse soft tissue edema of the right breast with complex fluid with internal echoes/debris coursing between the breast parenchyma consistent with mastitis. The patient was given intravenous (IV) fluids in the emergency department. She was brought into the hospital with concerns for mastitis without abscess and plans for IV clindamydin every 8 hours, warm compresses to the breast, encouraging pumping of breast milk from the breasts, and a surgery consultation.
The patient's maximum temperature was 100.4 degrees and she otherwise had a heart rate of 100, blood pressure 119/79, and oxygen saturation of 100% on room air. Lab results noted a WBC of 18.98. She was seen by surgery and underwent an incision and drainage of the breast at bedside with 120 cubic centimeters (cc) of fluid drained. She otherwise was continued on IV antibiotics, ibuprofen for pain control, warm compresses and with pumping of breast milk.
The patient remained afebrile with the WBC normalized and swelling, erythema and induration noted to be improving. She was continued on IV antibiotics, ibuprofen for pain control, warm compresses and was pumping the breast milk. The patient was discharged.
The health plan's determination is upheld.

The patient was brought into the hospital and initiated on IV clindamycin, underwent bedside incision and drainage, and was otherwise treated with warm compresses, Motrin, and encouragement of breast milk pumping. It is notable that after admission, she was afebrile, her leukocytosis normalized and she did not have pain requiring IV antibiotics. It is not clear from the documentation why-in the absence of fever, ongoing leukocytosis, need for further surgical intervention, or pain requiring IV antibiotics - this patient with no other medical issues who had not failed a trial of oral antibiotics prior to presentation could not have been safely discharged home with oral antibiotics. Inpatient stay was not medically necessary.
She had no other high risk condition such as uncontrolled diabetes who also had not failed a trial of antibiotics prior to admission could not have been safely treated with IV antibiotics and bedside incision and drainage at a lower level of care. Inpatient care was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Right Foot Cellulitis
 
Treatment: Inpatient Admission

The insurer denied the inpatient admission. The denial was upheld.   

This is a male patient with a history of diabetes mellitus, hypertension, and cerebrovascular accident who presented to the emergency department (ED) with complaints of right great toe that was reddened, swollen with discharge. Vital signs on presentation included a temperature of 98.3F, a blood pressure of 178/86, a pulse of 91, a respiratory rate of 18, and an oxygen saturation of 100% on room air. Laboratory results included the following: a white blood cell (WBC) count of 7.2, hemoglobin of 13.3, a hematocrit of 37.9, a creatinine of 0.79, and glucose of 271. The patient was admitted and started on intravenous antibiotics (clindamycin) for possible cellulitis of the right foot. He was consulted by Infectious Disease, Podiatry, and Orthopedics.  An x-ray of the right foot was obtained which was negative for an osteomyelitis. It was determined that the nail on the right great toe was infected; no surgical intervention was necessary. He was discharged home on oral antibiotics with podiatry follow up instructions. 

According to the documentation, the patient presented with a right 1st toenail infection. Otherwise, he was afebrile and hemodynamically stable with a normal WBC count on laboratory tests. He had an elevated serum glucose reflecting a history of chronic diabetes mellitus. The patient had a localized infection with no evidence of systemic toxicity, no failure of outpatient intervention, and no surgical intervention was required. 

The insurer acted reasonably, with sound medical judgment, and in the patient's best interest.

The carrier's denial of coverage for the inpatient admission is upheld. The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Malpositioned Teeth
Dental/Orthodontic Procedure

The patient is a female with a skeletal Class I occlusion, mild maxillary crowding and moderate mandibular crowding. Moderate overjet and moderate overbite. The proposed treatment is braces. The subject to be determined is the medical necessity for braces.

The health plan's determination is upheld.

Using the Handicapping Labio-Lingual Deviation (HLD) index, the malocclusion would score an 18 with no auto qualifiers. Auto qualifiers include deep impinging overbite, anterior crossbite causing clinical attachment loss and recession of the gingival margin, overjet 9 millimeter (mm) or greater and underbite 3.5mm or greater. The case requires a score of 26 or more for treatment to be considered medically necessary. The malocclusion in question does not meet standard criteria to be classified as handicapping and treatment would not be considered medically necessary. Thus, braces are not medically necessary for this case.
Appeal type: Formulary Exception
Decision: Upheld

This is a patient who has a listed diagnosis of migraine without aura.  The type of migraine is not specified.  It is unclear how the diagnosis was established. There is no detailed headache related history.  Headache clinical characteristics and duration are unknown; although it is mentioned examination that she has 4 headaches per month, some of which may last several days, and which have failed treatment with ibuprofen, Maxalt and Excedrin.  There is no documentation of any migraine prophylactic trial.  At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.
The health plan's determination is upheld.
The formulary approved drugs, topiramate, divalproex sodium, propranolol and timolol, are well established, first line migraine prophylactic agents.  Such drugs have a better established long term safety and efficacy than Aimovig, the requested drug.  The submitted medical records do not support a diagnosis of chronic migraines, given a lack of a detailed description of headache characteristics that would match any widely accepted diagnostic criteria.  Records also do not support that proper first line migraine prophylactic agent trials have failed at accepted doses, for 8 weeks or longer.  Such first line migraine prophylactic agents include the listed formulary medications.  Records also do not show an evaluation for rebound headaches, recommended as such headaches may limit usefulness of prophylactic agents.
There is no evidence, either from the patient's limited medical documentation or from high quality medical literature, large head to head randomized trials, to support that the requested medication would be more effective than all the available formulary drugs listed above.
Although side-effects are largely patient dependent, and therefore largely unpredictable, there is no evidence, either from the patient's limited medical documentation or from high quality medical literature or large randomized trials to support that the requested medication would have less adverse effects than all available formulary agents.