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

Diagnosis Ulcerative Colitis.
Treatment Stelara 90 mg every 6 weeks.
The insurer denied the Stelara 90 mg every 6 weeks.
The determination is upheld.

The patient has ulcerative colitis and psoriasis. He failed azathioprine, Remicade, Entyvio with methotrexate. He started Stelara with initial good response. He had the onset of symptoms (including psoriasis symptoms, diarrhea, and rectal bleeding) at approximately 7 weeks after Stelara injections. Although some of the gastrointestinal symptoms had improved, he continued to have a flare of psoriasis symptoms at 7 weeks after Stelara injections. Fecal calprotectin was elevated at 578 micrograms per gram (ug/g). Stelara 90 mg every 6 weeks for the treatment of ulcerative colitis is requested. At issue is whether the Stelera 90mg/ml every 6 weeks is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The Stelera 90mg/ml every 6 weeks is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease It is not supported by current medical literature. The patient had failed multiple medication classes for the treatment of ulcerative colitis [1,2]. Stelara has shown efficacy for the treatment of ulcerative colitis in a Phase III trial, UNIFI [3]. Although the Stelara dose of 90 mg every 4 weeks has been found to be effective in patients with Crohn's disease, there is a lack of sizable or high-quality studies for dose escalation for the treatment of ulcerative colitis [4-6]. The American Gastroenterological Association guidelines for management of Ulcerative Colitis and for therapeutic monitoring state that when there is loss of response to medication with a subtherapeutic drug level, the recommendation is to increase drug dose; a low drug level has not been demonstrated in this case [2,7]. Additionally, although Stelara dose escalation has been studied for the treatment of psoriasis, the current Stelara dose used in this case (which is standard dosing for the treatment of ulcerative colitis) already exceeds escalated doses studied for the treatment of psoriasis [8,9]. For these reasons, the request is not supported by the provided documentation.
There is a lack of published studies with sufficient size to demonstrate the efficacy of Stelara dose escalation for the treatment of ulcerative colitis.

The health plan's determination is upheld in whole.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Ulcerative Colitis.
Treatment:  Stelara 90 mg every 6 weeks.

The insurer denied the Stelara 90 mg every 6 weeks.  The determination is upheld.

The patient was diagnosed with with ulcerative colitis and has had 8 years of disease.  He started Stelara.  The patient also has psoriasis, for which the Stelara is beneficial.  On Stelara every 8 weeks, his psoriasis is not controlled the entire time and his fecal calprotectin has gone up to greater than (>) 500.  This has been associated with an increase in stool frequency and intermittent rectal bleeding.

The patient's provider has requested approval for Stelara to be changed from every 8 weeks to every 6 weeks.  This request was denied by the plan, as it exceeds the quantity limit.  The issue under review is whether the Stelara 90 mg/ml is likely to be more beneficial than standard treatment(s).

The proposed health service or treatment Stelara 90mg/ml every 6 weeks is not likely to be more beneficial than any standard treatment for the insured's ulcerative colitis.  I did a comprehensive review on Pubmed and could not find a single high quality article that addressed dose escalation of ustekinumab as rescue therapy for ulcerative colitis.  There is quite a bit of information on pharmacokinetics of ustekinumab as well as comparing every (Q) 8 to Q12 week dosing but nothing specific to address the issue in this case.  However, a lack of evidence does not indicate that dose escalation is unreasonable and would not be potentially beneficial for the patient.  The risk is extremely low as ustekinumab has a low probability of placing patients at risk for opportunistic infections. 
 There is no evidence that dosing Stelara every (Q) 6 weeks is beneficial as a rescue therapy in patients with breakthrough symptoms receiving Stelara Q 8 weeks.  This is based on a comprehensive literature search. The basis of the determination is the phase III trial which established that Q 8 week dosing was optimal and did not consider Q 6 dosing as a comparison arm (4).  I do not believe there are any high quality post-marketing data which carefully look at more frequent dosing.

The health plan's determination is upheld.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Asymptomatic premature menopause.
Treatment:  Vivelle Dot.

The insurer denied Vivelle Dot.  The denial is upheld.

The patient has a diagnosis of premature menopause.  She is using Vivelle-Dot for estrogen hormone replacement.  This is a non-formulary medication.  She indicated that a "generic" patch in the past caused weight loss and headaches.  The records indcated that she is not taking oral medication because of "fewer side effects and potential risks".  At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug(s), or would have adverse effects.

The non-formulary drug [Vivelle Dot] will not be more effective and would not be more effective as a formulary medication of estradiol patch, estradiol tablet, Estradiol cream, Menest tablet, Premarin cream, Premarin tablet Yuvafem.  The patient is taking Vivelle Dot for premature menopause and estrogen replacement.  She has attempted a "generic" patch in the past with side effects per the letter; however, the office notes do not document this.  In addition, there is no documentation of the estradiol tablet, Menest tablet, premarin and Yuvafem having been attempted and failed.  There is a sentence regarding the Dot having less side effects or risks, which is not supported by the medical literature.  Therefore, the non-formulary medication is not superior to formulary medication.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Epilepsy. 
Treatment:  Formulary exception for Depakote ER 500mg tablet. 

The insurer denied the Formulary exception for Depakote ER 500mg tablet.  The denial is upheld. 

The patient is a male with seizure disorder.  He has been treated with Depakote ER and has been clinically stable. 

No, the health plan should not cover the formulary exception for Depakote ER 500mg tablet. 

There is no evidence to support that Depakote brand is superior to the generic equivalent or the formulary alternative agents available to this patient.  Both the generic divalproex sodium, and the other preferred agents are Food and Drug Administration (FDA) approved for the treatment of his condition.  Standard of care guidelines support the use of generic medications in this clinical context.  There are protocols available to safely switch persons from one anticonvulsant to another agent, and serum drug levels can be monitored to safely convert the patient to generic Depakote.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental problems.
Treatment: Tooth colored caps (crown) for teeth numbers 8 and 9.
The insurer denied coverage for tooth colored caps (crown) for teeth numbers 8 and 9.
The denial is overturned. 

This is a male patient with a history of root canal treatment, cast and post on tooth number 8 who presented to the dental office after breaking the porcelain number 8. The crowns had deficient margins. The dentist advised to replace numbers 8 and 9 for shade to maintain anterior teeth and prevent further decay.

The patient presented for comprehensive dental treatment and failing long standing preexisting crown restorations on teeth numbers 8 and 9 was noted. There is radiographic evidence of open margins.  Based on these clinical findings the recommendation was replacement of the full coverage crowns on these teeth.  Based on clinical documentation, the preexisting full coverage crown restorations placed on this patient's teeth appear to be failing. The margins are open.  Radiographically there appears to be possible recurrent caries under the restorations.  Given this clinical circumstance, replacement of full coverage crowns is indicated, particularly on the endodontically treated incisor.  Replacement crowns are a conservative restorative option which would represent a standard of care for this clinical circumstance in general dental practice.  As such, these services which are also a covered service for this individual would be deemed medically necessary.

The coverage for tooth colored caps (crown) for teeth numbers 8 and 9 is considered medically necessary for this patient.

The health plan did not act reasonably with sound medical judgement, and in the best interest of the patient.

The carrier's denial of coverage for tooth colored caps (crown) for teeth numbers 8 and 9 should be overturned. The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Community acquired pneumonia, Acute kidney injury

Treatment: Admission for acute inpatient level of care

The insurer denied coverage for admission for acute inpatient level of care.

The denial is upheld.

This is a male patient with no significant past medical history who presented to the Emergency Department (ED) with a complaint of chest pain of 3 days duration. The patient was described as pleuritic in nature. On examination, the patient was in no acute distress, and was speaking in full sentences. The patient was alert and oriented. The patient had decreased breath sounds but otherwise unremarkable examination. The patient's electromagnetic radiation (x-ray) imaging of the chest revealed right upper lobe (RUL) opacity, and his computed tomography angiography (CTA) showed RUL consolidation with patchy infiltrated in the right middle and lower lobes. There was no pulmonary embolism. The patient's electrocardiogram (EKG) showed no acute changes, and the patient's troponin was negative.

The patient was admitted for community acquired pneumonia (CAP) and acute kidney injury (AKI). The patient was started on Intravenous (IV) antibiotics, IV fluids, and pain medications. The patient clinically improved with treatment and remained afebrile and hemodynamically stable.  Based on the review of the medical record and literature, this patient did not need inpatient level of care at the time of admission. The patient was afebrile, hemodynamically stable, tolerating oral intake and was not hypoxic. The patient's care could have been safely provided in the Observational level of care with IV antibiotics and fluids. After 24 hours of close monitoring, once stable, the patient could have been transitioned to oral antibiotics and medications and be discharged home with close outpatient follow-up. The patient's Pneumonia Severity score was 1 at presentation and quickly came down to 0 by the next day. Treatment in Observation level was appropriate for this patient without need for acute inpatient hospitalization. Thus, inpatient admission was not medically necessary for this patient. 

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

Based on the above, the medical necessity for admission for acute inpatient level of care is not substantiated. The insurer's denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Genetic Diseases-Other
Treatment: Genetic Testing-WES
The health plan denied the WES test as experimental/Investigational. The reviewer has overturned the HP determination in whole.

The patient has a medical history significant for abdominal pain, acute pancreatitis, consistently positive/elevated sweat chloride values and a family history of similar findings in a sibling along with cystic fibrosis in the mother's first cousin. Previous genetic evaluations have included two CFTR gene analyses (two separate labs), both of which were normal. Due to the lack of unifying diagnosis, the genetics team is requesting whole exome sequencing.

The proposed genetic testing is likely to be beneficial.
The American College of Medical Genetics and Genomics (ACMG) recommends exome sequencing for patients with a disorder that has a suspected genetic etiology when the patient's phenotype is not consistent with a specific disorder that has more targeted genetic testing currently available, the testing currently available for the patient's phenotype has failed to arrive at a diagnosis, or the suspected genetic condition is associated with a high degree of genetic heterogeneity.1 As demonstrated, the patient in the case readily meets these criteria.
Overall, the diagnostic yield of exome sequencing has been reported to range from 25-37% for individuals with a broad range of clinical phenotypes, specifically including neurodevelopmental disorders, epilepsy and other neurologic disorders, multiple congenital anomalies, and other suspected monogenic disorders.2-6 The diagnostic yield is highest when parental samples or other relevant family members are included in the analysis.2-6
A recent multidisciplinary consensus statement recommended exome sequencing as a first-tier genetic test for individuals with neurodevelopmental disorders including intellectual disability, global developmental delay, and autism spectrum disorder due to the high diagnostic yield.2 Multiple studies have found that exome sequencing is more cost effective than traditional testing approaches such as sequential single gene testing, multi-gene panels, serial imaging, biopsies, and other diagnostic approaches, and is most cost-effective when done early in the testing process.7-12
Patient Clinical Utility and Medical Management Implications:
The test results will guide and tailor appropriate medical management and treatment for this patient, which would not be possible without this testing. Exome sequencing can lead to direct changes in medical management, including modifications to medications, surgical interventions, surveillance regimens, or preventative measures that may be life-saving, and can eliminate the need for other expensive and often invasive diagnostic procedures. 8-10
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Genetic Diseases-Other
Treatment: Genetic Testing-WES
The health plan denied the WES test as experimental/Investigational. The reviewer has overturned the HP determination in whole.

The patient has multiple unexplained problems including abdominal pain, acute pancreatitis, and elevated sweat chloride level. Patient had a negative CFTR gene analysis for cystic fibrosis which was then repeated at another lab and was negative as well and also had a multi-gene pancreatitis level which was negative as well. Patient has a family history of abdominal pain, pancreatic insufficiency, borderline elevated sweat chloride level in her brother and cystic fibrosis in the mother's cousin. A medical geneticist therefore ordered whole exome sequencing (WES) to further clarify diagnosis which may help with management and recurrence risks.
WES would be evidence-based, cost effective and beneficial for this patient. The patient likely has a genetic process given  persistent abdominal pain, acute pancreatitis, and elevated sweat chloride levels in addition to positive family history. Finding the etiology would be best accomplished by testing all coding DNA (WES) which would be crucial for the patient's management, prognosis, and recurrence risks. Furthermore, several areas of possible health concerns may not be addressed if the patient's doctors do not know where to look and therefore potentially life-threatening complications may not be prevented.
WES can be used to identify the underlying molecular basis of a genetic disorder in an affected individual (Bamshad et al 2011). WES can test the largest number of genes than any other genetic test because it uses next-generation sequencing (NGS) technology that allows all genes to be sequenced simultaneously and therefore saves time and cost (Goh and Choi 2012). WES tests entire coding DNA with approximately 20,000 genes and parental samples are tested to help with interpretation of the results. Multiple studies have demonstrated over the past 10 years its vast power to identify disease-associated genetic variants across a diverse spectrum of human diseases which directly affects treatment (Green et al. 2013, Bainbridge et al. 2011). WES has been very effective as a clinical tool.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Severe Major Depressive Disorder
Treatment: Transcranial Magnetic Stimulation (TMS)
The insurer denied the Transcranial Magnetic Stimulation (TMS).
The denial is overturned. 

The patient is a female with a history of mental illness.  She has been diagnosed with F33.2 Severe Major Depressive Disorder, Recurrent.  She has been treated by multiple psychiatrists and with multiple medications.  She has done evidence-based psychotherapy with a licensed psychologist.  She has a PHQ (patient health questionnaire)-9 score of 23 and a MADRS (Montgomery-Asberg Depression Rating Scale) score of 37.  She has symptoms including decreased sleep/motivation/social interactions, irritability, feeling sad and depressed, and poor focus.  

The patient is currently taking Pristiq 100mg and Lamictal 50mg without full recovery of symptoms and has previously taken Wellbutrin, Trazodone, Vyvanse, Adderall, Concerta with notable side effects and lack of efficacy.

The patient's psychiatrist is recommending treatment with TMS (transcranial magnetic stimulation) for major depressive disorder.  It is noted that the patient cannot do ECT (electroconvulsive therapy) due to lack of transportation and risk of anesthesia.  The treatment offered is with Brainsway H7 coil, which has been cleared by the FDA (Food and Drug Administration) for usage.

Yes, the treatment with Transcranial Magnetic Stimulation is medically necessary.

The patient has a serious mental illness.  She has been diagnosed with severe major depression, and rating scales suggest significant impairment.  The patient has been treated with multiple medications as well as psychotherapy without symptom remission. She is therefore characterized as having treatment-resistant depression.  She is at risk of adverse outcomes due to severe depression. As noted by the patient's physician, ECT (electroconvulsive therapy) is not a viable treatment option for this patient. While the patient has not had medication trials with at least four prior antidepressants, she has been on a number of other medications, all with limited benefit. In this patient's scenario, TMS (transcranial magnetic stimulation) is entirely reasonable and within the accepted standard of care in the psychiatric community. Therefore, treatment with TMS is medically necessary.

TMS is an evidence-based treatment for treatment-resistant depression.  Brainsway H7 coil is FDA (Food and Drug Administration) approved for the treatment of the patient's condition.  Multiple prior evidence-based treatments including multiple different psychopharmacology regimens and psychotherapy have been ineffective in treating the patient's symptoms.  The patient is at risk of adverse outcomes due to her symptoms, and refusing treatment with this evidence-based treatment intervention is not in the patient's best interest.  It has been further recommended by a board-certified psychiatrist who knows the patient.  Therefore, it should be covered, as it is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Sepsis
Treatment: Skilled Nursing Facility
The insurer denied the Skilled Nursing Facility admission.
The determination is upheld.

This is a patient with multiple chronic medical conditions. She has a history of hypertension, a cerebrovascular accident (CVA), congestive heart failure (CHF), diabetes with neuropathy, peripheral vascular disease and a healed right leg wound. She was treated at the hospital for sepsis and discharged to a skilled nursing facility for subacute rehabilitation. At issue is the medical necessity of the patient's stay.
Based on the medical records reviewed, the patient did not have any acute medical problems that required the level of care provided by a skilled nursing facility and her rehabilitative status had improved to the point that it could have been continued at a lower level of care.
The physical therapy and occupational therapy recertification/progress report and updated therapy plans were reviewed. The physical therapy records noted that prior to hospitalization, the patient used a motorized wheelchair for long distance ambulation. It was not documented if she used any assistive device for short distances. On physical therapy reevaluation of the patient, her level of function had improved. On her initial evaluation with physical therapy, she walked a distance of 15 feet and by her evaluation she was walking 75 feet. She also had improvement with bed mobility and transfers. General strength of the right lower extremity had also improved from 3-/5 to 4-/5. Occupational therapy reassessment showed her activity tolerance for activities of daily living (ADLs)/functional tasks had improved from 30 seconds on to 30 minutes. Her functional mobility during ADLs had improved from Min(A) to contact guard assist. From a rehabilitation standpoint, the patient had improved and continued rehabilitative care if needed could be performed at a lower level of care. The patient did not have any medical needs that required intensive nursing care and from a rehabilitation standpoint, continued care could be provided at a lower level.
Appeal type: Medical necessity
Decision: Overturned


Diagnosis: anterior crossbite.
Treatment: Braces.
The insurer denied braces. The health plan's determination is overturned. 

The patient in question is a female with an anterior crossbite on teeth 7 and 10. She presents with a skeletal Class I malocclusion with moderate crowding in the maxilla and mandible. She is treatment planned for 18-24 months of orthodontics to address the crowding and crossbite.

The braces are medically necessary for this patient. This patient presents with an anterior crossbite on teeth 7 and 10, as well as significant crowding. Side effects of an untreated anterior crossbite include abnormal wear to the affected teeth and labial displacement of the mandibular incisors that can lead to periodontal defects. If left untreated, the damage that will likely occur to the patient's teeth will be much more time consuming and difficult to correct than the patient's existing orthodontic problem. For this reason, braces are deemed medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Fracture of tibia/fibula; s/p (status post) mechanical fall.
Treatment:  Inpatient admission.

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

The patient is a female, who fell while ice skating.  She was evaluated in ED (emergency department) and diagnosed with a closed displaced fracture to her right tibia/fibula.  She underwent intramedullary rodding to the tibia.  Her post-surgical course was non-complicated.

No, the inpatient admission was not medically necessary.

The medical record was significant for a non-complicated post-surgical course.  The young woman was reported to have no problems with pain.  She was able to tolerate oral medications.  Her vital signs were stable.  There were no problems with her surgical site.  She did not require medical attention for any other condition.  She had progressed with PT (physical therapy) and was independent with use of crutches.  There were no underlying comorbidities with increased risk of adverse event. 
 
These findings do not substantiate necessity for acute inpatient admission.  There were no extenuating circumstances to support the inpatient admission.