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

Diagnosis: Uterine leiomyosarcoma 
Treatment: Xalkori 
The insurer denied Xalkori. 
The denial is overturned.

This is a case of a female with uterine leiomyosarcoma. She has received the following therapies for the diagnosis of metastatic stage 4 (IV) disease: surgery followed by adjuvant chemotherapy regimen of Gemcitabine and Docetaxel for five cycles and second line chemotherapy with Doxorubicin started. Next Generation Molecular Sequencing (NGS) by FoundationOne profiling showed anaplastic lymphoma kinase (ALK) tensin-1 (TNS1)-ALK fusion, alpha thalassemia X-linked (ATRX) rearrangement of exon 3S, deoxyribonucleic acid (DNA) methyltransferase 3 alpha (DNMT3A) rearrangement of intron 2, rearrangement of exon 2, retinoblastoma (RB1) rearrangement intron 1 and tumor suppressor (TP53) mutation. The tumor mutational burden (TMB) was 5 mutations per megabase (muts/Mb). Micro-satellite status was equivocal. Treating medical oncologist is requesting crizotinib (Xalkori) for third line therapy for this patient based on the genomic abnormality discovered on NGS, the TNS1-ALK fusion.

At issue is the medical necessity of Xalkori 200 milligrams (MG) oral (OR) capsules (CAPS).

The health plan's determination is overturned in whole. 

The requested health service/treatment of Xalkori 200 MG OR CAPS is medically necessary for this patient.

Uterine sarcoma is a rare cancer and there are no standard United States Food and Drug Administration (FDA) approved therapies for chemotherapy refractory disease. Next generation sequencing such as FoundationOne can provide therapeutic targets for patients in management of such rare cancers. In this particular case, ALK rearrangement has provided a therapeutic option for an otherwise fatal malignant disease. ALK inhibition is shown to provide disease control in variety of malignancies with various ALK rearrangements. Under the supervision of an oncologist, Xalkori, an ALK inhibitor, is appropriate as the third line therapy for this patient.

Therefore, the requested health service/treatment of Xalkori 200 MG OR CAPS is medically necessary.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Morbid obesity

Treatment: Procedural code 43845 duodenal switch

The insurer denied coverage for procedural code 43845 duodenal switch.

The denial is overturned.

The patient has morbid obesity and gastroesophageal reflux disease (GERD). A lap band was placed. She lost 70 pounds but then the lap band became less effective. She gained weight and had a body mass index (BMI) of 48.9. The physician is now advising lap band removal and a duodenal switch. 

UpToDate article titled "Bariatric procedures for the management of severe obesity" discusses revisional procedures. There is a laparoscopic approach to a failed bypass with biliopancreatic diversion and duodenal switch. UpToDate gives a reference to an article from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). The guideline states that the Laparoscopic Duodenal Switch is a superior operation which preserves the antro-pyloric pump and leaves the vagal innervation undisturbed. A recent comparison of biliary pancreatic diversion and duodenal switch after 10 years of follow-up demonstrated the superiority of duodenal switch with better weight loss and lesser revisions. 

The scientific literature supports the use of the duodenal switch when a lap band has failed. It is advised by the Society of American Gastrointestinal and Endoscopic Surgeons. The patient is a good candidate because she has a failed lap band and has massive obesity. There are several options for patients with failed lap bands, but this procedure has been shown to be effective. It is likely to be more beneficial because it has been shown to produce superior weight loss as compared to other procedures. The risks are similar to any surgical procedure.

The carrier's denial of a surgical procedure on the stomach, procedure code 43845, should be overturned.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Substance abuse - polysubstance dependence.
Treatment: Inpatient substance rehabilitation/detoxification treatment.
The insurer denied coverage for inpatient substance rehabilitation/detoxification treatment.
The denial is overturned.

This female reportedly was admitted to inpatient substance rehabilitation/detoxification treatment. She reportedly could not maintain abstinence. It was reported that depression triggered her use. She reportedly was still using substances and drinking alcohol despite being in a Methadone program and taking 75 mg (milligrams) per day. 
  
The medical records provided enough specific evidence to support that she required this level of care then. The APA (American Psychological Association) Practice Guidelines for the Treatment of Patients with Substance Use Disorders reports that failure to achieve abstinence or patients who relapse frequently, currently abuse other substances, have very heavy use or tolerance (putting one at high risk for complicated withdrawal), are candidates for inpatient detoxification treatment. It also states that patients with past complicated or life-threatening withdrawal symptoms including withdrawal seizures or delirium tremens are in need of inpatient hospital treatment for the management of withdrawal and reports that patients with comorbid medical conditions that complicate the management of withdrawal are also candidates for inpatient detoxification. 

She needed 24-hour treatment then as she was at risk for severe, complicated, and even possible life-threatening withdrawal such as delirium tremens. She also was at risk for an overdose as she was using alcohol, heroin, cocaine, and amphetamines in large doses almost daily.  She also did require 24-hour hospital detoxification treatment and rehabilitation treatment prior to a long-term residential treatment, and it was considered unsafe for her to have detoxification or rehabilitation treatment at a less restrictive level of care then. As a result, the recommendation is to reverse the previous decision and approve coverage for inpatient substance rehabilitation/detoxification treatment. It did not appear that the health care plan acted reasonably, with sound clinical judgment, or in the best interests of the patient then.

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

The insurer's denial of coverage for the inpatient admission is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gastrointestinal reflux disease.
Treatment: Procedure code 43239, esophagogastroduodenoscopy (EGD).
The insurer denied coverage for procedure code 43239, esophagogastroduodenoscopy (EGD).
The denial is overturned.

The patient had plans to have bariatric surgery. She required an upper endoscopy prior to the procedure. She was having reflux symptoms. A 5 cm (centimeter) hiatus hernia was found as well as moderate erosions at the GE (gastroesophageal) junction. There was no H (Heliobacter) Pylori found. 

MCG (Milliman Care Guidelines) ACG: A-0203 lists indications for Upper GI (gastrointestinal) endoscopy. Gastrointestinal reflux disease with planned bariatric surgery is an indication to do an endoscopy. 

This patient had reflux disease and was planning on bariatric surgery. This met the MCG indication to do an endoscopy. The health care plan did not act reasonably or in the best interest of the patient. Doing an upper gastrointestinal endoscopy was medically necessary. 

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

The insurer's denial of coverage for procedure code 43239, esophagogastroduodenoscopy (EGD), is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease (GERD)

Treatment: procedure code 43239, esophagogastroduodenoscopy (EGD)

The insurer denied coverage for procedure code 43239, EGD

The denial is overturned

The patient has a history of chronic esophageal reflux disease. He was not on recent anti-reflux medications. He had a history of having an esophageal ulcer. He also had not had a colonoscopy in over a decade. An endoscopy revealed an esophageal ulcer and gastritis. The biopsy showed an ulcer and active esophagitis. At the gastroesophageal (GE) junction there was a Hill 2 GE flap. 

Milliman care Guideline (MCG) ACG: A-0203 lists indications for Upper Gastrointestinal (GI) Endoscopy. A male who has had GERD for 5 years with a hiatal hernia is an indication for the procedure. Severe erosive esophagitis after proton pump inhibitor (PPI) treatment is also an indication to do an endoscopy.

This patient has chronic GERD and a history of severe esophagitis with an esophageal ulcer. The GE junction finding with an abnormal Hill Classification is part of a hiatal hernia evaluation and is associated with reflux. In addition, the patient has known severe esophagitis and never had a follow up endoscopy. In view of his age, the history of an esophageal ulcer, and the abnormal Hill classification it was appropriate to do an endoscopy. The health care plan did not act with sound medical judgment or in the best interest of the patient. Doing an upper GI endoscopy was medically necessary. 

The insurer's denial of coverage for procedure code 43239, esophagogastroduodenoscopy (EGD) is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Acute Diverticulitis
Treatment: Inpatient admission
The insurer denied the inpatient admission
The denial is upheld

The patient is a female with prior history of diverticulitis with IR (interventional radiologiy) drainage of abscess. The patient underwent unsuccessful drainage of undrained collection. The patient accidentally cut her tube and presented to the hospital for tube exchange. The patient was admitted for tube exchange. The patient was afebrile with no leukocytosis and no abdominal pain. The tube was exchanged and she was sent home.

No the Inpatient Admission was not medically necessary.
The treatment plan for tube exchange was medically appropriate and was needed since the patient cut her IR (interventional radiology) pigtail tube. However, this patient's treatment could have been rendered at a lower level of care. The patient did not demonstrate abdominal pain, leukocytosis, or any other complication of her drain being cut.

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.
The patient could have been managed at a lower level of care for tube exchange rather than inpatient level of care. The patient did not have any pain, elevated WBC (white blood cell count) or derangement in her vitals signs that necessitated an inpatient level of care. Although the Milliman care guidelines cite abscess as a criteria for inpatient admission for diverticulitis, there was no evidence that there was a clinical complication from the drain being cut. This could have been managed at a lower level of care.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Chronic low back pain

Treatment: pain management; outpatient procedure (Intraosseous Nerve Ablation-Intracept procedure) 

The insurer denied coverage for pain management; outpatient procedure (Intraosseous Nerve Ablation-Intracept procedure)

The denial is upheld

This female has chronic low back pain. She has had Epidural steroid injections, Medial branch blocks, Physical therapy, and home exercises. Her medication trials have included: Cyclobenzaprine, Gabapentin and Prednisone. A magnetic resonance imaging (MRI) shows Modic changes at L(lumbar)5-S(sacral)1 and the request is for radiofrequency ablation (RFA) of basivertebral nerves at those 2 levels.

In 2018, Fischgrund, and colleagues (1) published a double-blind, sham controlled randomized control trail (RCT) evaluating the Intracept system and RFA of the Basivertebral nerve for the treatment of chronic low back pain. The primary efficacy endpoint was the comparative change in Oswestry disability index (ODI) from baseline to 3 months. There was a significant mean reduction in ODI at 5 years compared with baseline (42.8 and 25.95, respectively, p<0.001). Mean visual analogue scale (VAS) score was also significantly lower at 5 years (4.38) compared with baseline (6.74), p<0.001. In addition, 66% of individuals reported at least a 50% reduction in VAS at five-years compared with baseline and 34% reported complete pain resolution. It is unclear whether the reduction in ODI is related to treatment, or other factors, given the absence of a comparison group.

A second RCT evaluating the Intracept system, known as the INTRACEPT trial (2), was published by Khalil and colleagues in 2019. The trial was open label and compared intraosseous RFA treatment to standard care in individuals with at least 6 months of chronic low back pain who had not responded to at least 6 months of conservative care. The primary study endpoint was difference in the ODI at 3 months. For the primary outcome, the mean change in the ODI at 3 months in the interim analysis was -25.3 points in the Intracept group and -4.4 points in the standard care group, p<0.001. Mean change in VAS was -3.46 points in the Intracept group and -0.01 in the standard care group, p<0.001. As specified in the study protocol, the study was halted and individuals in the standard care group were allowed to cross over to treatment with the Intracept system. Limitations of this study include the lack of a sham control and limited duration of follow-up.
 
In sum, the publications to date have been company sponsored and had methodology flaws. There is no published data on long term complication rates. There are other evidence-based interventions available to this patient, such intra-thecal medications. This procedure is unlikely to be more beneficial than the standard approaches.

The carrier's denial of pain management; outpatient procedure (Intraosseous Nerve Ablation-Intracept procedure) should be upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Status post pylorus preserving Whipple for enlarging pancreatic duct
Treatment: continued hospital admission
The insurer denied coverage for continued hospital admission
The denial is overturned

The Whipple procedure is a complex surgical operation with a high morbidity and mortality. Pancreatectomy-specific complications such as pancreatic leaks, delayed gastric emptying, and postoperative hemorrhage contribute to prolonged length of stay. [1] Delayed gastric emptying has a significant impact on clinical outcomes and resource utilization in the post-operative period.

Per clinical documentation, this is a female who presented to undergo a Whipple procedure (pancreaticoduodenectomy). A JP (Jackson Pratt) drain was left.  The patient had continued nausea and bloating after the procedure. A CT (computed tomography) scan demonstrated "fluid extending inferiorly and superiorly into the left upper quadrant showing signs of early organization; distended afferent loop to the level of the gastrojejunal anastomosis." On postoperative day eight, patient-controlled analgesia was restarted. The patient had an esophagogastroduodenoscopy (EGD) that demonstrated an edematous duodenojejunostomy with inflammation, which was dilated. There was also noted to be angulation of the afferent limb with retained bilious contents. The patient's diet was advanced as tolerated and there was continued improvement. Per MCG (Milliman Care Guidelines) criteria, an extended stay beyond goal length of stay may be needed for complications of the procedure (i.e., postoperative abscess or infection) or in delayed gastric emptying (e.g., unable to tolerate diet). Goal length of stay is 6 days postoperative. Per clinical documentation, the patient had CT scan findings consistent with a possible intraabdominal abscess. There was persistent nausea and vomiting consistent with delayed gastric emptying. Therefore, the continued hospital stay was medically necessary.

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

The insurer's denial of coverage for continued hospital admission is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Syncope.
Treatment: Inpatient admission. 
The insurer denied coverage for an inpatient admission. 
The denial is upheld.

This is a male patient with type II diabetes, on insulin therapy. He has a history of diabetes, hypertension (HTN), and chronic renal disease stage 5 secondary to diabetes. The patient was seen in the emergency room (ER) as a transfer from nephrology clinic. The initial concern was for a syncopal episode. The patient's blood sugar was noted to be 67 at that time. EMS (emergency medical services) rechecked it and it was 93. He was admitted to evaluate his low blood sugar and the syncopal episode. He had taken his short acting insulin that morning but did not eat his usual breakfast. In the ER, VS (vital signs) were normal, cardiac/lungs and neurological exam were all normal. He was evaluated with troponin, basic metabolic panel (BMP) and creatinine. The findings were consistent with known CKD (chronic kidney disease). Of note was that his K (potassium) was 4.9, CO2 (carbon dioxide) 23 and TN (troponin) .05 and .03. His blood sugar (BS) in the ER was 116. He was admitted and transferred to the floor on telemetry. The patient was stable with no further episodes of syncope. 

The inpatient hospital admission is not considered medically necessary for this patient. This patient had known advanced renal failure and was being evaluated for a shunt. The lab values were all consistent with his underlying renal failure. There were no findings consistent with an acute cardiac or neurologic event. If the syncope was related to hypoglycemia, this was already corrected at the time he was seen by EMS. This patient could have been managed during a period of observation after the initial ER evaluation.

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

The insurer's denial of coverage for the inpatient hospital admission is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental Caries.

Treatment: ambulatory surgery, dental anesthesia and procedures.

The insurer denied coverage for ambulatory surgery, dental anesthesia and procedures.

The denial is overturned.

Upon review of the documentation submitted this patient significant dental needs that would be difficult to provide in the outpatient setting due to significant dental disease, age of the patient and documented poor compliance/anxiety. Therefore, it was recommended that all treatment be performed in a controlled setting under deep sedation/general anesthesia. This provides the benefit of completing all dental needs at one time and anesthesia as patient compliance. This is a standard of care treatment for this clinical situation when dealing with pediatric patients. This treatment is supported in the literature. Further, the treatment plan as recommended fulfills and meets all the insurer's medical necessity criteria. As such the services recommended are considered medically necessary.

Overturn denial of coverage for ambulatory surgery, dental anesthesia, and procedures. The treatment as recommended meets the insurer's criteria for medical necessity and would be a standard of care in pediatric dental practice.

Ambulatory surgery, dental anesthesia, and procedures is considered medically necessary for this patient.

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

The insurer's denial of coverage for ambulatory surgery, dental anesthesia and procedures is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Malocclusion.

Treatment: comprehensive orthodontic treatment visit of adolescent dentition and periodic orthodontic treatment visit.

The insurer denied coverage for comprehensive orthodontic treatment visit of adolescent dentition and periodic orthodontic treatment visit.

The denial is overturned.

Upon review of the submitted documentation including lateral cephalometric radiograph, panoramic radiograph, montage of extraoral and intraoral clinical images, dental treatment noted as well as insurer correspondence, it appears that this patient presented for evaluation for orthodontic care. The orthodontist identified overjet overbite, and anterior crowding. The orthodontist has completed the HLD Handicapping Labio-Lingual Deviation (HLD) index attaining 26 total points. 

Upon review of the submitted documentation (study models were not provided for review) it is evident that the patient exhibits a malocclusion. However, to assess for severity of the malocclusion class 11 and therefore medical/dental necessity for orthodontic care, New York State requires the use of an orthodontic Index, the Handicapping Labio-Lingual Deviation Index Report (HLD, New York State Medicaid program) modeled after Handicapping Labiolingual Deviation Index. This index provides six specific conditions that automatically qualify for orthodontic care. Additional criteria are used utilizing a point system if none of these initial qualifying conditions are met or selected. For these other secondary criteria to qualify for orthodontic care a total score of26 points is necessary. 

In this case, the treating orthodontist completes the second portion of the index arriving at 26 points to justify orthodontic care. This reviewer concurs with the index completed by the orthodontist which meets the threshold of 26 points to support orthodontic care. 
Regarding the validity of the Handicapping Labiolingual Index, it has been shown through scientific scrutiny in peer reviewed journals that this methodology for assessing orthodontic need is a valid approach. Each of these peer reviewed articles concludes that this index is a valid and reliable determinant of need for orthodontic care. As this is an accepted methodology, this has been determined to represent an appropriate approach for assessing orthodontic need. 

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

The insurer's denial of coverage for comprehensive orthodontic treatment of adolescent dentition and periodic orthodontic treatment visit is overturned. Medical Necessity is substantiated.