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

Diagnosis: Lightheadedness, Dizziness  
 
Treatment: Inpatient Admission

The insurer denied the Inpatient Admission. The denial was upheld. 

This is an elderly female who presented to the Emergency Department (ED) in early 2019 with complaints of lightheadedness, headache, hand tremors and unsteadiness when standing. The patient' documentation indicates that her complaints were due to anxiety.  The patient has a history of hypertension, hyperlipidemia, cardiovascular accident (CVA), tobacco abuse, alcohol abuse, anxiety and laparoscopy. While in the hospital she had an MRI of the brain revealed prior punctate acute infarct within the left centrum semiovale that had resolved. There was no evidence of acute infarct. The patient was hemodynamically stable and then discharged home with instructions to follow up with her primary care doctor.

There was no indication that the patient had findings of acute bacterial labyrinthitis, cerebellar, brainstem or cerebral ischemia or hemorrhage, suspected etiology that requires admission for treatment, hemodynamic instability, signs or symptoms that are severe persistent, vomiting that is severe persistent, cardiac arrhythmias of immediate concern, severe neurological findings requiring inpatient care, continuous intravenous infusion of anticoagulation platelet inhibitor needed, cerebral bleeding, hydrocephalus or vasospasm monitoring required or increased intracranial pressure cerebral edema monitoring. The documentation indicated that the patient was seen in the ED due to complaints of dizziness/lightheadedness with worsening tremors due to anxiety.  

Based on the above, the medical necessity for the inpatient admission.  The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Teratogen exposure and family history of Down Syndrome
Treatment: 81420 - Prenatal genetic testing 

The 81420 - prenatal genetic testing was not medically necessary.

Because Down syndrome is primarily a non-disjunctional event, an isolated remote family history such as cousin of the father of the baby does not substantively raise the risk for the index pregnancy.  Ingestion of teratogenic substances, if indeed the substances in question are teratogenic, does not raise the risk for Down syndrome.  Therefore, no evidence is presented that the patient is at high risk for Down syndrome.  

Because standard multiple marker screening (sequential screen) has the highest detection rate for all chromosomal abnormalities and is also the most effective strategy in terms of quality-adjusted life-years for women aged 20-38 years, the Society for Maternal and Fetal Medicine does not recommend the alternative proposed in this case, cell free DNA screening, as a primary screening strategy for low risk women such as this patient.  Therefore the treatment proposed, cell-free DNA screening CPT 81420, is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate Cancer
Issue under review: OncotypeDX prostate cancer test

Determination:
The OncotypeDX prostate cancer test was not medically necessary.

Per AUA Guidelines, "14. Among most low-risk localized prostate cancer patients, tissue based genomic biomarkers have not shown a clear role in the selection of candidates for active surveillance. (Expert Opinion)."

The patient has a low-risk prostate cancer.

The NCCN Guidelines note that, "Their clinical utility awaits evaluation by prospective, randomized clinical trials, which are unlikely to be done."

The NCCN Guidelines state that, "In summary, although molecular test results can provide additional guidance to patients, only limited data of prostate cancer specific-survival are available, and whether patient outcomes are improved with use of these tests is unclearany of these tests may be considered to aid management decisions, but they are not required for standard of care at this time."
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Familial Mediterranean Fever

Treatment: Medication management

The insurer denied the drug Otezla. That denial was reversed.

The patient has FMF (Familial Mediterranean Fever) and steroid-responsive abdominal pain from small bowel involvement from Behcet's Disease.  The FMF has been controlled in the past with anti-IL1 therapy, but this does not help the abdominal pain.  Multiple treatments for the abdominal pain have failed.  He has been on Stelara recently, but the FMF is active and the abdominal pain responded only partially.  The plan is to return to Ilaris therapy for the FMF and use apremilast (Otezla) for the Behcet's, avoiding Actemra as monotherapy for both FMF and Behcet's due to the risk of intestinal perforation (he has a history of diverticulitis as well as intestinal Behcet's).

There is no FDA-approved treatment for this condition.  The insurer has denied coverage, noting that there is no data on the risks or benefits when combining Otezla with biologics (in this case Ilaris).  Treatment with anti-TNF and mesalamine has failed, and treatment with apremilast is being sought due to an increased risk of intestinal perforation with Actemra, a treatment that would otherwise be considered as it potentially can treat both illnesses.  It is pointed out that there is some published data on benefit from Otezla for oral ulcers from Behcet's.  It is also noted that there is published data on mixing Otezla with biologics.  There is no data specifically for the clinical picture here (FMF plus treatment-resistant abdominal pain from Bechet's), but by extension Otezla is a reasonable choice. It should be noted that the combination of FMF with Behcet's limited to the small bowel is very rare.  This makes the likelihood of large studies comparing different treatments remote.  Further compounding the treatment problems here are the wide variety of failed past treatments and the increased risks of Actemra treatment as noted in the office visit and response letter. 

There is limited data on efficacy of Otezla for small bowel Behcet's, although it has shown promise for mucocutaneous disease.  The health plan acted reasonably in being concerned about the use of Otezla with a biologic, where toxicity has been studied to only a limited degree.  However, the unusual extenuating factors in this case, as noted above, are what change the assessment of potential risk and benefit. Therefore, Otezla is considered medically necessary for this patient's clinical condition
Appeal type: Medical necessity
Decision: Overturned

The patient has been diagnosed with plagiocephaly and left sided torticollis.  According to notes and letters by the pediatrician, the patient has worsened despite at least 3 months of home repositioning and physical therapy.

Anthropometric cranial measurements were performed.  The cranial vault asymmetry was 10 millimeter (mm), cephalic vault asymmetry index was 4.29 mm, and cephalic index was 100 (greater than [>] 2 standard deviation [SD] of 87.5).

The health plan's determination is overturned.

In a review of 15 studies on cranial molding helmets for positional plagiocephaly, Tamber et al. [1] found that "there is a fairly substantive body of non-randomized evidence that demonstrates more significant and faster improvement of cranial shape in infants with positional plagiocephaly treated with a helmet in comparison with conservative therapy, especially if the deformity is severe, provided that helmet therapy is applied during the appropriate period of infancy."  Kunz et al. [2] concluded that age at the beginning of treatment and severity of asymmetry have a definite impact on the duration and effectiveness of molding orthosis therapy.  The authors followed 144 patients with deformational plagiocephaly treated by molding orthosis who were examined and divided into three age groups (group I, less than [< ]24 weeks; group II, greater than or equal to [>] 24 to < 32 weeks; and group III, > 32 weeks) and two severity levels (mild to moderate, 30-degree cranial vault asymmetry > 3 mm to less than or equal to > 12 mm; and moderate to severe, 30-degree cranial vault asymmetry >12 mm).  The extent of the reduction of asymmetry was analyzed using three-dimensional stereophotogrammetry.  Therapy with molding orthosis led to a significant reduction in asymmetry in all defined age groups.  Efficacy of reduction decreased with increasing age.  Successful treatment (cranial vault asymmetry index < 3.5 percent) was achieved in 83, 69, and 40 percent of patients with mild to moderate asymmetry in groups I, II, and III, respectively; and in 50, 30, and 7 percent of patients with moderate to severe asymmetry in groups I, II, and III, respectively.  The average duration of treatment increased from 18.6 weeks to 25.3 weeks (age groups I and III).

This patient has severe left sided torticollis and plagiocephaly, with a cephalic index of 100 significantly greater than 2 SD of 87.5.  The deformity is worsening despite home repositioning and physical therapy.  A cranial orthosis is medically necessary and should be instituted as soon as possible in order to obtain optimal results (Tamber et al. and Kunz et al.).
Appeal type: Experimental/Investigational
Decision: Upheld

This is a patient with chronic gastroesophageal reflux disease (GERD). He has had mid-epigastric pain, intermittent dysphagia, and chronic cough. He had an esophagogastroduodenoscopy (EGD) with a Bravo study in  revealing reflux esophagitis without goblets cells. His DeMeester Score was 25.5. He had an esophagogastroduodenoscopy (EGD) revealing a small hiatal hernia. He had an esophagogram on  revealing trace GERD. His body mass index (BMI) is 29.16. He has been prescribed Pantoprazole 40 milligrams (mg) daily. He has now been recommended to have a transoral incisionless fundoplication (TIF) procedure. The health plan's determination is upheld.
The Transoral Incisionless Fundoplication is not likely to be more beneficial than any standard treatment for the patient's GERD. There are significant questions which remain with respect to the long-term safety and efficacy of the procedure. This is supported by current peer-reviewed medical literature.
"Studies have shown that approximately 3% to 10% of patients who undergo TIF will experience some type of adverse event. Some of the more concerning side effects of TIF include mucosal tear, perforation, bleeding, pneumothorax, and mediastinal abscess. From a providers' point of view, it appears that gastroenterologists are hesitant to refer patients for TIF because of the concern about the durability of this procedure. More research is needed regarding the value of these techniques in different clinical scenarios." [Ronnie Fass. An Overview of Transoral Incisionless Fundoplication and Magnetic Sphincter Augmentation for GERD. Gastroenterology & Hepatology. 2017 (13): 50].
"Transoral incisionless fundoplication and radiofrequency energy delivery were not judged appropriate in any scenario." [Rena Yadlapati et al. Management Options for Patients with GERD and Persistent Symptoms on Proton Pump Inhibitors: Recommendations from an Expert Panel. The American Journal of Gastroenterology. 2018 (113): 980].
"Optimization of therapy (improving compliance and timing of PPI doses), or increasing PPI dosage to twice daily in select circumstances can reduce persistent symptoms." [C. Prakash Gyawali et al. Management of Gastroesophageal Reflux Disease. Gastroenterology. 2018 (154): 302-318].
"TIF is a minimally invasive endoscopic procedure, yet based on evaluation of benefits versus risks, we do not recommend it as a long-term alternative to proton-pump inhibitors (PPI) or laparoscopic Nissen fundoplication (LNF) treatment of GERD." [Joel E. Richter et al. Efficacy of Laparoscopic Nissen Fundoplication versus Transoral Incisionless Fundoplication or Proton Pump Inhibitors in Patients With Gastroesophageal Reflux Disease: A Systematic Review and Network Meta-Analysis. Gastroenterology. 2018 (154): 1298-1308].
Appeal type: Experimental/Investigational
Decision: Upheld

This is a patient  under evaluation and management for gastroesophageal reflux disease (GERD). The patient has had symptoms for 8-10 years. He had a positive potential hydrogen (pH) study confirming the presence of acid reflux. He has been reliant on pantoprazole to control heartburn, throat clearing and cough. He previously was on lansoprazole supplemented with an H2 blocker. The patient underwent a barium esophagram which was unremarkable except for small amount of reflux. An upper endoscopy identified a small hiatal hernia but was otherwise normal. A previous endoscopy had described a 3 centimeter (cm) hiatal hernia.
The patient's provider has recommended the Transoral Incisionless Fundoplication with EsophyX Device as treatment. The heal plan's determination is upheld.
Transoral incisionless fundoplication (TIF) is an endoscopic procedure performed under general anesthesia to create a full-thickness serosa-to-serosa plication that is 3 to 5 cm in length and 200 to 300 degrees in circumference. [1] It is recommended that TIF be performed in patients with typical GERD symptoms with no extraesophageal symptoms of GERD, no or minimal erosive esophagitis and no or only small hiatal hernia (less than or equal to [2] cm).[2] This patient fulfills those criteria although he does have extraesophageal symptoms (cough) and the first endoscopy mentioned the hiatal hernia was greater than 2 cm.
However, based on the lack of demonstration of durability in the face of a chronic disease and the fact that TIF is not as efficacious in improving the lower esophageal sphincter as a reflux barrier compared to laparoscopic fundoplication (LF), the standard operation. That is, although TIF is associated with fewer postoperative adverse effects such as gas bloating and dysphagia compared with LF, the durability of TIF is less efficacious over time compared with LF.
Appeal type: Experimental/Investigational
Decision: Upheld

This is a patient with gastroesophageal reflux disease (GERD). He presented with ongoing heartburn for 7-8 years. He has had a chronic cough, and breakthrough symptoms every 3-4 months, with mid-epigastric pain, acid brash, and cough. An esophagogastroduodenoscopy (EGD)  showed a small hiatal hernia and an esophageal ring; a potential hydrogen (pH) study at that time was consistent with acid reflux and showed elevated esophageal acid exposure with a DeMeester score of 23.9. He has been on pantoprazole since then. Esophagogastroduodenoscopy  showed a small hiatal hernia, and otherwise normal esophagus, stomach, and duodenum. Esophagogram for the indication of dysphagia on showed trace gastroesophageal reflux. He has failed proton pump inhibitor (including pantoprazole and lansoprazole) and H2 receptor antagonist therapy (including famotidine). 
The health plan's determination is upheld.  It has not been definitively established that transoral incisionless fundoplication (TIF) using the EsophyX device is likely to be more beneficial to the patient than standard therapies.  The efficacy of TIF using the EsophyX device has been studied in randomized controlled trials (Sami, et al). However, the conclusions are contradictory: one large randomized trial including 60 patients found no improvement in esophageal acid exposure compared with baseline at 12 months; normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of proton pump inhibitors (PPIs) in 61% (Witteman, et al). The study concluded that no long-term objective reflux control was achieved. The 2013 American College of Gastroenterology guidelines for treatment of GERD report that "the usage of current endoscopic therapy or TIF cannot be recommended as an alternative to medical or traditional surgical therapy (moderate level of evidence)" (Katz, et al).  Those guidelines also do not recommend endoscopic procedures for GERD in patients with Barrett's esophagus (Katz, et al).  A recent systematic review and meta-analysis concluded that "future controlled trials are needed to directly compare efficacy, long-term durability, and safety between TIF and Nissen fundoplication" (McCarty, et al).  In 2013 the Society of American Gastrointestinal and Endoscopic Surgeons reported that numerous published series have reported significant adverse events and that there is a lack of sham-controlled trials comparing TIF with anti-reflux surgery; SAGES concluded that "further studies are required to define optimal techniques and most appropriate patient selection criteria, and to further evaluate device and technique safety (Auyang, et al). These conclusions are bolstered by recent reports of severe adverse events during the procedure and the need for surgery to revise ineffective TIF (Ashfaq, et al; Bell, et al; Edress, et al).
Appeal type: Medical necessity
Decision: Overturned

The patient is a male to female transgender.  The patient was treated with breast augmentation in 1995.  The implants have deflated.  The surgeon recommends removal of the deflated implants and placement of new implants.  This is the subject under review.

The health plan's determination is overturned.  The Breast augmentation surgery is medically necessary and standard of care for this patient.  The requested implant removal and breast augmentation is consistent with the WPATH criteria.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Coronary artery disease
 
Treatment:  Inpatient admission, monitoring

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

This patient had a past medical history of coronary artery disease, hypertension, hyperlipidemia, sleep apnea, and tobacco abuse.  He presented for an elective cardiac catheterization.  He had a known diffusely diseased left internal mammary artery (LIMA) to left anterior descending (LAD) graft; therefore, an attempt was made at chronic total occlusion percutaneous coronary revascularization.  This was unsuccessful, and plans were made to bring the patient back to the catheterization lab for a retrograde attempt in the future.  There were no procedural complications, and the patient was then admitted for further monitoring.  The patient remained hemodynamically stable, was ambulatory, and was tolerating oral intake.  There were no vascular access complications.  The patient was subsequently discharged home after an uneventful, brief overnight hospital stay. 

Inpatient admission status is not medically necessary for this patient.  Per MCG Angioplasty, Percutaneous Coronary Intervention ORG: M-52 (ISC), this procedure is an outpatient one.  The clinical presentation and peri-procedural course were unremarkable and uneventful, and acute inpatient level monitoring was not medically necessary or appropriate.  There were no extenuating circumstances in this case that warranted inpatient admission status following elective cardiac catheterization and attempted angioplasty.  

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

Diagnosis: Migraine Headaches
Treatment: Aimovig
The requested medication, Aimovig, is not medically necessary.

There is no documented reason as to why the patient cannot be treated with the preferred formulary agents.  The medical records do not support and adequate trial or contraindication to any of the preferred agents. There are no high quality clinical trials or standard of care guidelines supporting the preferential use or superiority of Aimovig relative to the preferred agents, Metoprolol, Timolol, Nadolol, Atenolol, Divalproex Delayed-Release or Extended-Release tablet, Amitriptyline, Nortriptyline, and Venlafaxine ER. Therefore, the treatment with Aimovig is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

This is a patient with a history of metastatic medulloblastoma undergoing chemotherapy per the HEAD START intravenous (IV) protocol, and possible glycogen storage disease. He presented for care  with acute worsening of his occipital headache while receiving ertapenem at home for multi-drug resistant Escherichia (E.) coli infection based on a previous positive blood culture, with the need to continue the IV antibiotics. Given the nature of his headaches, difficulties with examination based on his age, underlying possible storage disease, and need for further observation and monitoring, he was admitted to the pediatric oncology service. Cycle 3 of his chemotherapy protocol was also started. The health plan's determination is overturned.
This patient was admitted for his chemotherapy treatment protocol per the HEAD START 4 plan. This chemotherapy cannot be safely provided in the outpatient setting given the need for continuous and aggressive IV fluids, rescue medications and level monitoring. In addition, the patient had multiple complications during his stay to include cardiac (issues with his central line and cardiac function), respiratory (bronchitis versus pneumonia, breathing difficulties), musculoskeletal (myositis, need for imaging and orthopedic evaluation), hematologic (need for multiple blood and platelet transfusions), infectious disease (fevers, need for IV antibiotics and culture monitoring), and oncologic (need for imaging of his disease and concerns for possible relapse).
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cerebral venous thrombosis
Treatment: JAK2 mutation assay
JAK2 mutation assay was not medically necessary. 

JAK2 mutation is strongly associated with myeloproliferative neoplasms (MPNs), most notably polycythemia vera.  MPNs are associated with risk of venous thrombosis. However, at the present time there is no evidence from any prospective clinical trial indicating that testing for JAK2 in the setting of provoked venous thrombosis and in the absence of any other sign of an underlying MPN can improve health outcomes.  Such testing is not recommended as a standard test based on any supporting evidence in the evaluation of patients with provoked venous thrombosis. Therefore, testing in this case was not medically necessary.