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

Diagnosis:  Gastroesophageal Reflux Disease without Esophagitis.
Treatment:  Esophageal Sphincter Augmentation Device.

The insurer denied Esophageal Sphincter Augmentation Device. The health plan's determination is upheld. 

This patient is a man (with body mass index (BMI) 33), who sought surgical evaluation for the condition of gastroesophageal reflux disease (GERD). The surgical history and physical (H&P) states that the patient has had symptoms of heartburn for 18-years. He has been treated with Nexium and Omeprazole. Despite this, he continues to have breakthrough symptoms. He denies dysphagia. The patient was evaluated due to ongoing symptoms.

Considering the submitted documentation, the published literature, and the clinical details of this case, the LINX procedure is not likely to be more beneficial than other treatment(s) for this patient.

LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the U.S. Food and Drug Administration (FDA) to be lawfully marketed for the treatment of GERD. LINX is not subject to review and approval by any institutional review board for the proposed use. LINX is not the subject of an ongoing clinical trial that meets the definition of a Phase 1, 2 or 3 clinical trial set forth in the FDA regulations. Finally, there is sufficient long-term data to support that this therapy is as efficacious as the established alternative (laparoscopic fundoplication) for the treatment of GERD in appropriately selected cases. However, in this case, the patient has esophageal dysmotility.  Fifty-five percent of swallows were ineffective (9% [percent] failed and 45% weak).

LINX is not standard care as treatment of GERD in the setting of esophageal dysmotility. While LINX is a proven effective therapy for appropriately selected patients with GERD (pathologic esophageal acid exposure, preserved esophageal function, no contraindicating anatomic abnormality or alternative diagnosis), LINX is not proven primary therapy for this patient's symptoms of GERD in the setting of esophageal dysfunction.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crossbite
Treatment: Insertion of Braces and Adjustment of Braces
The insurer denied: Insertion of Braces and Adjustment of Braces
The denial is overturned

The patient is an adolescent male requesting orthodontic benefits. He has a Class I malocclusion, mild upper crowding and moderate lower crowding, and a deep bite. The prior denial was due scoring 13 on the handicapping index score.

The proposed treatment is medically necessary.

Even though the handicapping index score was only 13, the patient has an anterior tooth (#27) in crossbite (reverse bite). This means this tooth is in front of the upper tooth. There is also gingival (gum) attachment loss with recession. This is an "automatic qualifier' according to the Salzmann index. This patient needs orthodontic treatment to correct his bite.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Transient left sided weakness and slurred speech with headache and dizziness
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is upheld

The patient is an adult female who presented to the emergency room with transient left sided weakness and slurred speech with headache and dizziness. Her blood pressure was noted to be hypertensive. Neurological examination was significant for slow speech. An electrocardiogram (EKG), computed tomography (CT) of the head, and magnetic resonance image (MRI) of the brain were done and were negative for stroke. The patient was admitted for further workup. She was recommended to follow-up for vestibular rehabilitation.

Inpatient hospitalization was not medically necessary.

This patient had transient neurologic symptoms which were thought to be a transient ischemic attack. Per the Milliman Care Guidelines (MCG), criteria indicate admission when a patient has a severe neurological deficit. This was not the case in this patient as this patient was only noted to have slow speech which is not considered severe. This case could have been further managed and evaluated on an observation basis.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal and chest pain with associated nausea
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is upheld

The patient is an adult female with anxiety, depression, as well as history of "fad diets" and laxative abuse who was hospitalized with abdominal and chest pain with associated nausea. She had been severely restricting her calorie intake. She was afebrile with 
stable vital signs. Labs were notable for phosphorous less than 0.7. Her creatinine and the remainder of her electrolytes were unremarkable. Troponins and chest film were unremarkable. 

Her phosphorous was repleted and monitored. On day #2, her phosphorous was within normal limits. The patient was discharged the next day. The plan denied the inpatient hospitalization, noting a lack of severe findings that would warrant inpatient level of care, such as abnormal vital signs, hypoxemia, severe electrolyte abnormalities, arrhythmia, or pericardial effusion. A final adverse determination upheld the denial of inpatient hospitalization, again noting a lack of abnormal vital signs, altered mental status, or seizure and further noting that the patient could have been managed in a lower level of care. On appeal, medical records are provided, but there is no specific rationale for appeal noted.

The proposed treatment was not medically necessary.

The documentation does not reflect findings that support inpatient level of service, per criteria in the evidence-based guideline "Systemic or Infectious Condition GRG (MG-SIC)" in Milliman Care Guidelines 26th edition, which reflects standards of care. According to this guideline, "Severe electrolyte abnormalities requiring inpatient care" include:
"Phosphorus less than 1 mg/dL (0.32 mmol/L) not corrected to near normal or near chronic baseline despite observation care treatment. Phosphorus less than 1.5 mg/dL (0.48 mmol/L) with severe finding requiring inpatient management (e.g., weakness, altered mental status, seizures)."

These criteria are not met. The patient was admitted for a primary diagnosis of hypophosphatemia in the setting of dietary restriction. However, her phosphorous responded to treatment and normalized by the next day. Additionally, there was no evidence of muscle weakness or other neurological deficits documented on physical exam, no evidence of altered mental status, and no evidence of seizures. Medical services could have safely and effectively been provided in a lower level of care. Thus, the proposed treatment of inpatient hospital admission was not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Metastatic non-small cell lung cancer. 
Treatment: Foundation One Liquid CDx. 

The insurer denied: Foundation One CDx. 
The denial is overturned. 

The patient is a male with metastatic non-small cell lung cancer (adenocarcinoma). The patient recurred while receiving adjuvant cisplatin+pemetrexed. The Foundation One Liquid CDx was obtained and is under review for medical necessity. 

The targeted genomic sequence analysis panel is medically necessary. The use of next generation sequencing gene panels to guide the treatment of patients with metastatic non-small cell lung cancer is recommended by the National Comprehensive Cancer Network (NCCN) Guidelines, which state "...t is recommended at this time that when feasible, testing be performed via a broad, panel-based approach, most typically performed by next generation sequencing (NGS)....". The assay in question is Food and Drug Administration (FDA) approved and evaluates the cancer for the recommended biomarkers - epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS1, met proto-oncogene (MET), rearranged during transfection (RET), human epidermal growth factor receptor 2 (HER2), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), Kirsten rat sarcoma (KRAS), and Tropomyosin receptor kinase (TRK). 

The authors of UpToDate state "...ext generation sequencing (NGS) overcomes many of the shortcomings of direct sequencing and allele-specific testing... It retains sensitivity even in specimens with low tumor cellularity, which is an improvement over direct sequencing, and can identify new abnormalities, which would not be detected by allele-specific testing. Moreover, NGS can often detect abnormalities that would historically be tested by fluorescence in situ hybridization (FISH)...". Finally, NGS panel testing has been demonstrated in multiple trials, to be less expensive than single gene testing for the recommended biomarkers. The service under review is not the subject of ongoing investigation for these purposes. 

For these reasons, the use of this assay in this scenario meets criteria for medical necessity.
Appeal type: Medical necessity
Decision: Upheld


Diagnosis: Cholecystitis
Treatment: Inpatient Hospital Stay
The insurer denied the Inpatient Hospital Stay.
The determination is upheld.

This is a male patient who presented to the emergency department (ED) with a complaint of new onset abdominal pain. His past medical history is significant for diabetes The vital signs were normal at the time of presentation. The white blood cell count (WBC) count was normal at 10.4 thousand (K). Liver enzymes and bilirubin were elevated. The patient was admitted to the hospital and started on intravenous (IV) antibiotics. The surgical history and physical (H&P) states that he had tenderness in the right upper quadrant. An ultrasound showed gallstones in the gallbladder, a thickened gallbladder wall and pericholecystic fluid.
The patient underwent a laparoscopic cholecystectomy. The operative dictation describes that cholecystectomy was performed without complication. There were findings of cholecystitis. His vital signs were normal and the patient was tolerating food. His glucose was elevated. The WBC count and liver enzymes/bilirubin were improved.
An endocrinology consultation was obtained for recommendations regarding his diabetes management. The patient's diet was advanced and pain was controlled with oral medications. His vital signs were normal. The patient remained clinically stable and was discharged from the inpatient setting with instructions for surgical and endocrinology follow up. At issue is the medical necessity of an inpatient stay.

An inpatient level of care was not medically necessary in this case. This patient presented to the hospital with the complaint of abdominal pain. At the time of presentation, the patient had normal vital signs and was clinically stable. His evaluation identified gallstones. Surgical consultation was obtained and the patient underwent a laparoscopic cholecystectomy .
There is no documentation of hemodynamic, pulmonary, neurological, or metabolic reason for an acute inpatient level of care at the time of presentation. Additionally, there is no documentation of failure to achieve discharge criteria, conversion to open surgery, care for comorbidities, procedural complications, or any other condition requiring inpatient admission.
In the early post-surgical recovery, the patient was noted to have elevated glucose levels and was evaluated with endocrinology consultation (prior to discharge) for recommendations on diabetes management. He was advanced on a diet and lab data showed improvement in liver enzymes and bilirubin. Acute inpatient care was not medically necessary for this patient as the care and treatment provided could have been rendered with a lower level of care.
A lower level of care would have provided for initial assessment, perioperative care and monitoring, provision of intravenous (IV) fluid, surgical consultation, performance of cholecystectomy, and overnight monitoring. There were no peri-procedure complications or other clinical issues that mandated an inpatient level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Dermatitis
Treatment: Pharmacy/Prescription Drugs/Dupixent 200 milligrams (mg)/1.14 milliliter (ml)
The health plan denied the requested Dupixent 200MG/1.14ML as not medically necessary. 
The health plan's determination is upheld.

The patient is a male with moderate to severe atopic dermatitis (Investigator Global Assessment (IGA) score of 4.0) that affects the neck, arms, legs, back, and abdomen. The patient has reportedly tried and failed topical 2.5%(percent) Hydrocortisone and Triamcinolone, as well as topical Tacrolimus. However, the patient previously was denied coverage of Tacrolimus because of an inadequate trial and failure of topical steroids, and there are no paid claims for Tacrolimus.
Dupixent 200 milligrams (mg)/1.14 milliliter (ml) is under review for medical necessity.

The health plan's determination of medical necessity is recommended to be upheld, in whole.

No. The patient has had insufficient use of topical agents such as topical Tacrolimus and more potent topical steroids, and no documented trial of alternative traditional/oral therapies that would make further use of topical therapies moot. Systemic therapy (such as Dupixent) is therefore, not medically necessary, and is being prescribed out of preference and/or convenience instead of true medical necessity.
The patient has insufficient to no documented treatment failure with, or true medical contraindication to, either topical calcineurin inhibitors or more potent topical steroids, and/or standard, first-line oral medications used for moderate to severe atopic dermatitis (such as Methotrexate, Azathioprine, or Mycophenolate Mofetil) that would obviate the need for further topical therapies (despite these oral medications not being required step therapy for Dupixent). In particular, the lack of treatment with Tacrolimus to reduce the need for topical steroids and/or systemic therapy is not sufficiently documented in a manner confirming this treatment was adequately accessed, tried and failed.
Dupixent is not proven to be superior to all other formulary alternatives as per comparative, controlled studies. Therefore, as per the patient's health plan policy language, [1] and consistent with current medical literature, [2-5] the requested Dupixent is not medically necessary and does not meet the health plan coverage requirements.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease. 
Treatment: Blood test, procedure code 80145. 

The insurer denied coverage for blood test, procedure code 80145. 

The denial is upheld. 

Office visit note reported the patient was being seen for an ileal stricture with ileorectal fistula.  It was noted that Humira was started. Colonoscopy/endoscopy completed revealed rectal fistula with otherwise normal findings. Esophagogastroduodenoscopy (EGD) noted erosive gastropathy with unremarkable pathology. Treatment plan included Humira trough level with continued Humira every other week. Letter reported it was standard of care practice to assess drug levels/drug neutralizing antibodies every 6 months to prophylactically manage and optimize patient's medical therapy. Determination letter reported the requested lab test was denied given lack of proof that treatment would improve health. 

In this case, the patient was noted to be taking Humira. The requested lab test was approximately 1 year since starting therapy. However, there is a lack of documentation of any change in subjective or objective clinical findings to suspect subtherapeutic levels of Humira.  There was no documentation of lack of or decrease response to current use of Humira to warrant testing. 

Scientific evidence in peer-reviewed literature does support a result of improvement in health outcome for patients with lack of response to Humira. In this case, the patient was not a good candidate for blood test, procedure code 80145, given lack of documentation of change in response to treatment. The blood test, procedure code 80145 was not the best available treatment for this patient at this time. The adverse risks were not increased over standard treatment/services. The requested service was not likely to be more beneficial than any of the standard treatments/procedures for this patient. 

In summary, the denial of  blood test, procedure code 80145 should be upheld.  This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are not substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease. 
Treatment: Blood test, procedure code 80145. 

The insurer denied coverage for blood test, procedure code 80145. 

The denial is overturned. 

Serum concentrations of adalimumab (ADA) may vary among equally dosed patients which can ultimately affect patient outcomes. Suboptimal levels of ADA have been linked to lower response rates in irritable bowel disease (IBD) patients. Furthermore, some patients may develop immunogenicity to ADA by producing antibodies to adalimumab (ATA). The presence of ATA has also been associated with increased rates of infusion reactions and drug clearance leading to lower response rates. Therefore, the quantitative measurement of ADA levels in serum provides healthcare providers with valuable information to help them gain a better understanding of the factors that may be affecting a patient's loss of response. 

The ADA assay levels test is a next-generation quantitative monitoring assay that allows healthcare providers to measure and monitor serum ADA and ATA levels at any time during therapy. Incorporating therapeutic drug monitoring may clarify what factors are contributing to a patient's loss of response and help patient management by providing information to help decide an appropriate course of action. 

In summary, the denial of  blood test, procedure code 80145 should be overturned. 

This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are not substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease. 
Treatment: Blood test, procedure code 80145. 

The insurer denied coverage for blood test, procedure code 80145. 

The denial is overturned. 

The patient has a history of Crohn's disease with an ileal stricture and an ileal rectal fistula. He has had intestinal obstructions and has required intestinal surgery. He was started on adalimumab and his doctor has now recommended adalimumab levels and drug antibody levels. He writes that therapeutic drug monitoring is an important part of treatment for this patient. 

The American Journal of Gastroenterology 2010 May 105(5):1133-1139 has an article titled "Clinical utility of measuring infliximab and human anti-chimeric concentrations in patients with inflammatory bowel disease." The conclusion was that measuring infliximab concentrations and antibody levels is clinically useful. Increasing the drug dose may be a good strategy if infliximab levels are subtherapeutic. 

Clinical Gastroenterology and Hepatology 2019;17:1656-1688 has an article titled "Appropriate Therapeutic Monitoring of Biologic Agents for Patients with Inflammatory Bowel Disease (IBD)." The conclusion states that consensus was achieved towards the utility of therapeutic drug monitoring of biologics in patients with IBD, particularly if receiving anti- tumor necrosis factor (TNF) TNF therapy. For patients receiving anti-TNF therapies, proactive therapeutic drug monitoring was found to be appropriate after induction and at least once during maintenance therapy. 

This patient has advanced Crohn's disease and requires optimal treatment of his biologic agent. Therapeutic drug monitoring is an established practice in treating patients with IBD and is supported in the peer reviewed medical literature. It has been shown to improve health care. Testing for blood levels of adalimumab and antibody levels is approved by regulatory bodies. This patient is a good candidate for therapeutic drug monitoring because he has severe disease with obstructions and a fistula. It is the best way to monitor blood levels and to see if antibodies are developing. There are no adverse risks ln obtaining therapeutic drug monitoring. It is likely to be beneficial for this patient to undergo therapeutic drug monitoring. 

In summary, the denial of  blood test, procedure code 80145 should be overturned. 

This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are not substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Skeletal class I malocclusion. 
Treatment: D8080 Comprehensive Orthodontic Treatment, D8670 Monthly Visit. 

The insurer denied the D8080 Comprehensive Orthodontic Treatment, D8670 Monthly Visit. 

The denial is overturned. 

The patient is a male with a skeletal class I malocclusion.  He has moderate upper and lower crowding and a deep bite. He also has a narrow upper arch. 

The prior denial was due to not reaching a score of 26 on the handicapping index scale. 

Yes, the proposed braces and office visits are medically necessary. 
The patient has an impacted upper right permanent canine (tooth # [number] 6). When there is an impacted permanent anterior tooth where extraction is not indicated, this is an "automatic qualifier" according to the handicapping index scale. 

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Ulcerative Colitis
Treatment: Formulary exception for Lialda
The insurer denied the formulary exception for Lialda.
The denial is overturned.

The patient is an adult male with ulcerative colitis in remission on Lialda (brand mesalamine). He has flared with generic mesalamine and balsalazide. His provider is requesting brand mesalamine (Lialda). Lialda was denied coverage by the health plan, as the patient has not failed 3 preferred formulary alternatives. The denial is being appealed.

The plan should cover the formulary exception for Lialda (brand mesalamine). 

The patient has failed generic mesalamine and balsalazide. The other preferred agent, sulfasalazine, is not as effective as Lialda in ulcerative colitis and causes more side effects. Therefore, as two formulary drugs have been ineffective, and as sulfasalazine is not likely to be as effective as Lialda, and as sulfasalazine is more likely to have side effects than Lialda, the health plan should cover the formulary exception for Lialda.