Persius/hicric huggingface dataset:
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Type 2 diabetes mellitus.
Treatment: Formulary Exception for Janumet.

The insurer denied coverage for the Formulary Exception for Janumet. The denial is upheld. 

This is a female patient who has a history of type 2 diabetes mellitus with complications as evidenced by the presence of bilateral great toe diabetic ulcers. The patient had a routine general examination at a healthcare facility. She denied any fever, chills, and malaise. She was feeling generally well without any specific complaints. Her medications included amlodipine, aspirin, enalapril, Farxiga, Jentadueto, Lipofen, Synthroid, and Vitamin D3. 

The insurer has received a prescription benefit exception request from the claimant's doctor for Janumet (sitagliptin-metformin). The request for a benefit plan exception was denied by the insurer because it did not meet established criteria defined by the prescription plan. The insurer's formulary alternatives are: Jentadueto and Jentadueto XR.

The formulary drug, based on documentation is unlikely to cause the patient an adverse reaction. Based on medical facts from the available records, claim documentation, and any additional information obtained from the patient's treating provider(s) from the perspective of Endocrinology Diabetes & Metabolism/Internal Medicine, the submitted documentation has not provided sufficient evidence to substantiate failure of Jentadueto therapy.

Jentadueto is a combination drug of metformin and linagliptin. The latter is a dipeptidyl peptidase 4 (DPP-4) inhibitor, which is similar and as efficacious as Janumet. Janumet is a combination of metformin and sitagliptin. The requested drug, Janumet, is not going to be more efficacious than Jentadueto. The issue is the relative efficacy of sitagliptin compared to linagliptin since both are combined with metformin.

Craddy et al. performed a systematic review of the various DPP-4 inhibitors which included 83 randomized trials which involved 5 different DPP-4 inhibitors including linagliptin and sitagliptin. They concluded that these drugs "showed similar efficacy and safety for DPP-4 inhibitors as treatment for type 2 diabetes, either as monotherapy or combination therapy."

Keshavarz et al. did a meta-analysis focused on linagliptin and sitagliptin both alone and in combination with metformin which included 32 studies. They concluded that "Based on the results, there was no significant difference between the two drugs, i.e. linagliptin and sitagliptin, in terms of efficacy; in other words, the efficacy of the two drugs was the same. Therefore, the use of these two drugs depends on their availability and cost." 

The carrier's denial of the request for Formulary Exception for Janumet is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Bacterial Intestinal Infection And Irritable Bowel Syndrome
Treatment: Xifaxan 550mg
The insurer denied the Xifaxan 550mg.
The denial is upheld. 

The patient is a male whose request for XIFAXAN 550 milligrams (MG) (rifaximin) is under review. The patient has a history of human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), Kaposi sarcoma, and CD4 (cluster of differentiation 4) nadir of 350 cells/ul. The patient also suffers from small intestinal bacterial overgrowth. The patient is currently taking BIKTARVY, boosted darunavir and maraviroc, and HIV is well-controlled. The patient has a history of abdominal bloating and diarrhea and was diagnosed with small intestinal bacterial overgrowth; he is currently undergoing treatment with XIFAXAN 550MG (rifaximin).

No, the proposed treatment with XIFAXAN is not medically necessary.

Currently, this medication is not approved for small bowel intestinal overgrowth, although some studies have shown a benefit in the use of this medication and this is the most studied medication for this condition (1). Most studies have studied up to one month of treatment (1). The patient is currently on this antibiotic, but no information is given on current symptoms, response to treatment, if the medication is to be used prophylactically or symptomatically, and duration of the proposed treatment, etc. As such, the medication cannot be approved.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alzheimer's disease, Depression, Osteoarthritis and Urinary incontinence
Treatment: Consumer Directed Personal Assistance Program (CDPAP) service: 15 Hours per Day - 7 Days per Week - a total of 105 Hours per Week
The insurer denied the Consumer Directed Personal Assistance Program (CDPAP) service: 15 Hours per Day - 7 Days per Week - a total of 105 Hours per Week.
The denial is overturned. 

The patient is male with a history of Alzheimer's disease, Depression, Osteoarthritis and Urinary incontinence. Due to impairments related to these conditions, he requires assistance for completion of the majority of his activities of daily living (ADLs). An appeal review was requested for potential approval of 105 hours/week Personal Assistance Services to offer increased ADL (activities of daily living) support.

Yes, the proposed treatment of 105 hours/week Personal Assistance Services is deemed medically necessary.  

This is a male with a history of Alzheimer's disease, Depression, Osteoarthritis and Urinary incontinence. Due to impairments related to these conditions, he requires assistance for completion of the majority of his activities of daily living (ADLs). Furthermore, recent documentation from the patient's Neurologist indicates that due to patient's progressively worsening dementia, cognitive impairment and gait ataxia, the currently approved plan of 70 hours per week Personal Assistance Services is no longer sufficient to meet the patient's current needs. For these reasons, the proposed treatment 105 hours per week Personal Assistance Services is deemed medically necessary.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Insomnia.
Treatment:  Formulary exception for Dayvigo (lemborexant) 10 MG (milligram) Tablet.

The insurer denied the Formulary exception for Dayvigo (lemborexant) 10 MG (milligram) Tablet.  The denial is upheld. 

The patient is a female diagnosed with a sleep disorder, insomnia.  The patient has been prescribed Dayvigo (Lemborexant) 10 mg (milligrams) tablet daily to address her sleep disturbance.  The patient has failed to benefit from multiple medications that include melatonin, Unisom, Xanax, gabapentin and trazodone, as well as being prescribed medications targeting bipolar mood disorder and generalized anxiety disorder (co-morbid psychiatric conditions).  The patient has not tried or failed to benefit from the health plan formulary alternatives that include zolpidem (Ambien), zaleplon (Sonata), and eszopiclone (Lunesta).

The patient's clinician is requesting coverage for treatment with Dayvigo at the dosage of 10 mg (milligrams) daily targeting symptoms of sleep disturbance/insomnia in keeping with FDA (Food and Drug Administration) indications.  The prescribing physician argues that Dayvigo is indicated to avoid use of a sedative-hypnotic that may interact with lorazepam or result in daytime drowsiness impacting the patient's ability to function or result in a safety issue.

No, the health plan should not cover the Formulary exception for Dayvigo (lemborexant) 10 MG (milligram) Tablet.

The Dayvigo 10 mg (milligrams) tablet is prescribed for an FDA (Food and Drug Administration)-indicated diagnosis of insomnia.  However, the patient has not failed a trial with other hypnotic agents that are available in generic formulation and have also been deemed to be safe and effective by the FDA (Food and Drug Administration).  Moreover, the plan guidelines are reasonable requiring a trial and failure of formulary alternatives before allowing a coverage exception.  In this case, the plan does cover several alternative hypnotic agents that are as likely to be beneficial for the patient in this case scenario.  The requested benefit of Dayvigo at a 10 mg (milligrams) dosage is therefore considered not medically necessary, as generic alternatives zaleplon, zolpidem and eszopiclone are available with FDA (Food and Drug Administration) approval for the indication under treatment in this case.

In summary, a formulary exception for Dayvigo should not be covered in keeping with plan criteria/guidelines and in keeping with the instructions for this NY (New York) State mandated review.  The patient has not tried and failed to benefit from the remaining generic formulary alternatives, as the health plan asserts and as outlined in the clinical summary for this case review.  Formulary alternatives are reasonable and consistent with sound medical judgment for treatment of insomnia in this case.  This answer is consistent with the scientific literature and published guidelines, referenced below, including guidelines pertaining to the patient's comorbid conditions associated with the insomnia.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Psoriasis vulgaris 
Treatment: Taltz 80 mg/ml syringe
The insurer denied coverage for a Taltz syringe 80 mg/ml 
The denial is upheld.

This male patient has a history of psoriasis and has previously tried and failed Clobetasol cream and Clobetasol solution, Humira, Enbrel, and Methotrexate which caused nausea. The patient also has a history of sarcoidosis. The requested medication is Taltz.  

The formulary drugs Humira, Otezla, Stelara, Skyrizi, Tremfya, Cosentyx and Cimzia are not likely to cause the patient an adverse reaction. The preferred formulary drug, Cosentyx, has a similar mechanism of action as the requested medication, Taltz. Both are Interleukin-17 (IL-17) inhibitors and both medications have a similar safety profile.  

A recent report based on pooled data from 21 randomized trial of Cosentyx in the treatment of psoriasis, psoriatic arthritis and ankylosing spondylitis examined the safety profile: "The most frequent AE was upper respiratory tract infection.  EAIRs across PsO, PsA, and AS indications were generally low for serious infections (1.4, 1.9, and 1.2, respectively), Candida infections (2.2, 1.5, and 0.7, respectively), inflammatory bowel disease (0.01, 0.05, and 0.1, respectively), and major adverse cardiac events (0.3, 0.4, and 0.6, respectively). No cases of tuberculosis reactivation were reported.  The incidence of treatment-emergent anti-drug antibodies was low with secukinumab across all studies, with no discernible loss of efficacy, unexpected alterations in pharmacokinetics, or association with immunogenicity-related AEs." (Deodhar, A. et al. 2019)      

The patient has tried and failed the formulary medication, Humira according to the provided clinical notes. The patient has not tried and failed any other formulary medications.     

While Taltz is a Food and Drug Administration (FDA) approved and effective biologic drug for the treatment of psoriasis, its efficacy is similar to the preferred formulary agents Skyrizi, Tremfya and Cosentyx.  While there are no direct head to head trials comparing the efficacy of these agents, a recent network meta-analysis of 60 clinical trials published by Armstrong, AW, et al. (2020) compared the Psoriasis Area and Severity Index (PASI) assessment of 75%, 90%, and 100% reductions (PASI 75, 90, and 100) for different biologic agents.  

The requested drug is not likely to be more effective than the formulary drugs.

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

The carrier's denial of request for formulary exception for Taltz 80 mg/ml syringe is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Back Pain.
Treatment:  Spinal Fusion.

The health plan denied the requested spinal fusion.   The health plan's determination is upheld.

The patient is a female, who had an (lumbar to sacral) L4 to S1 fusion.  Apparently, she did quite well for a number of years but began to develop right posterior lower back and buttock pain without radiation into the right leg.  This is improved with lying down and sitting and worsened with walking and standing still.  There is documentation from the patient in a phone call to the physician following the initial denial for the requested right SIJ (sacroiliac joint) fusion procedure that this is severely affecting her daily activities.  In addition, she reported in a phone conversation that she had attended physical therapy (PT) in the past and continued to try doing the prescribed HEP (home exercise program), but these aggravated her symptoms, and she had to stop them.  It is unclear when she actually attended PT.  There is documentation in a office visit note that she was to continue self-supervised exercises.

She has been diagnosed with post-lumbar fusion right SIJ dysfunction.  Her neurological examination is reportedly normal.  There are numerous physical examinations in the records provided that document tenderness over the right SIJ and at least 3 positive provocative maneuvers regarding the SIJ (thigh thrust, Faber's, compression, distraction).  She has tried pain medications as well as medical cannabis.  She underwent bariatric surgery, and her current body mass index (BMI) is 38.  She is a former smoker - having quit. 

At this time, the records provided support upholding the health plan's determination of medical necessity, in whole.

No, the requested service is not medically necessary or appropriate for this patient at this time.  While there is increasing acceptance and evidence within the spine surgery literature (see references below) of the benefits of SIJ fusion for intractable symptomatic SIJ dysfunction in carefully selected patients who have exhausted all non-operative measures, including patients who have had prior lower lumbar fusion procedures, this patient does not yet meet those criteria.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Elevated creatinine
Treatment: Inpatient admission
The insurer denied coverage for the inpatient admission. 
The denial is upheld. 

This is a male patient who presented to the Emergency Department (ED) with a past medical history of hyperlipidemia, hypertension, and diabetes. The patient presented for an evaluation of dizziness that he had experienced the day before while working. The patient worked as a cook and it was really hot the day before. The patient reported feeling dizzy and went home. The patient denied any headache, visual changes, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, or any other complaints. The patient's physical examination showed that his blood pressure was 114/71, his respirations were 18, and that he was not in acute distress and was not diaphoretic. The patient was alert and oriented to person, place, and time, and his mental status was at baseline. The patient's behavior was normal. The patient's electrocardiogram (EKG)was also normal. The patient's blood urea nitrogen (BUN) was 28, and his creatinine was 3.21. The patient's estimated glomerular filtration rate (eGFR) was 25. There was an inability to determine if the patient had acute versus subacute kidney injury. The patient had his last work-up with his primary care about 4 months before the evaluation. The provider was unable to determine the patient's renal baseline, so the patient was admitted for observation and nephrology consultation. The patient's renal status improved and the patient was discharged on day 2 of admission in stable condition.

Based on the review of the medical record and literature, the inpatient admission was not medically necessary for this patient. The patient presented with an elevated creatinine of unclear etiology and unclear chronicity. Due to this, further evaluation including imaging, urine testing, intravenous (IV) hydration, and continued follow up, was necessary. After initial evaluation during a period of observation, the patient's care could have been provided at a lower level of care. There is insufficient evidence that inpatient level of care was warranted.

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

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

Dental Problems
Dental/Orthodontic Procedure

Diagnosis: Dental Problems
Treatment: Bone Grafting 
The insurer denied bone grafting of teeth number (#) 11 and 13. The health plan's determination is overturned. 

The patient is a male who presents for evaluation and treatment of teeth #11 and 13. Provided for review are previous letters of appeal and denial, full mouth radiographic images, one page of American Dental Association (ADA) claim forms, a narrative from the provider, and clinical notes. In question is the medical necessity of the treatment of bone graft for site of teeth #11 and 13 (D7953).

The Bone Grafting in the Site of Teeth #11 and 13 is medically necessary for this patient.

Based on the provided documentation, there is a need to preserve the ridge dimensions after the teeth were extracted. If the ridge dimensions are not preserved, a dental implant would not be able to be placed at a future date without more significant grafting.
The stated reason for grafting for both teeth #11 and 13 was for preservation of the ridge for dental implants at the time of extraction. This qualifies as medically necessary as it preserves the ridge dimensions to allow for future implant placement. Dental implants require bone to surround the implant and offer a base for osseointegration. Without adequate bone dimension, the implant cannot be placed. Grafting at the site of extraction prevents soft tissue ingrowth and loss of bone dimension as a result. Hence, the requested treatment is required for both #11 and 13 as it is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Rule out acute coronary syndrome
Treatment: Inpatient admission
The insurer denied coverage for the inpatient admission.
The denial is upheld.

This is a male patient with a history of hypertension, hepatitis C infection, asthma, and polysubstance abuse with tobacco, alcohol, heroin, and benzodiazepines. The patient presented to the Emergency Department (ED) requesting admission for alcohol detoxification. The patient was admitted to rule out acute coronary syndrome.

The patient's initial vital signs included blood pressure (BP) 136/86, heart rate 70, temperature 98.0, and oxygen saturation 98% on room air. The patient's electrocardiogram (EKG) was normal other than a corrected QT interval (QTc) of 513 milliseconds. The patient's urine screen revealed cocaine, methadone, benzodiazepines, and opiates. The patient's Clinical Institute Withdrawal Assessment (CIWA) for Alcohol score was 5 and his Clinical Opiate Withdrawal Scale (COWS) was 6. The patient's laboratory test results included white blood cell (WBC) 8.6, hemoglobin 8.8, and creatinine 0.67. The patient's chest X-ray and abdominal and pelvis computed tomography (CT) scans were normal. Records on day 2 of admission indicate that the patient complained of left-sided chest pain, not relieved with sublingual nitroglycerin, for which Percocet was ordered, with no subsequent chest pain noted. The patient's troponin level was 0.03 on the day of admission and 0.00 on day 2 of admission. The patient's vital signs remained stable. The patient's QTc decreased to 475 milliseconds on day 3 of admission, then to 465 milliseconds on day 4 of admission, but no significant arrhythmias were noted. The patient was treated with pantoprazole for gastritis, and was discharged on day 4 of admission on folate, multiple vitamins, thiamine, nicotine patch, as well as his home albuterol inhaler and Symbicort.

Based on the review of the medical record and literature, there is no supporting evidence that this patient required an acute inpatient level of care to evaluate his chest or abdominal discomfort, or to rule out acute coronary syndrome. This patient was hemodynamically stable. This diagnostic workup could have been completed in the ED or at an observation level of care.  His CIWA score indicated mild withdrawal symptoms. Thus, inpatient admission was not medically necessary for this patient.

The healthcare plan acted reasonable, with sound medical judgement, and in the best interest of the patient.

Based on the above, the medical necessity for the inpatient admission is not substantiated. The insurer's denial should be upheld.
Appeal type: Medical necessity
Decision: Overturned


Diagnosis: Genitourinary/ Kidney Disorder- UTI
Treatment: Inpatient stay
The health plan denied the inpatient stay as not medically necessary. 
The reviewer has overturned the health plan's determination in whole.

The patient has a history of coronary artery disease (CAD), hypertension, diabetes, status/post gastric bypass, and anxiety. The patient presented to the emergency room with abdominal pain, vomiting, mild hemoptysis, black tarry stools, and diarrhea. The vital signs were initially notable for a systolic blood pressure of 50, pulse 139, and a temperature of 100.7 degrees. The patient appeared to be in no acute distress and non-toxic. Physical exam was normal except for mild epigastric and suprapubic tenderness. Labs were notable for a white blood cell  count of 12,400, hemoglobin  9.4 g/dl, platelet count 72,000, lactic acid 2.6, and a urinalysis consistent with a urinary tract infection. The chest x-ray was unremarkable. A computed tomography scan of the abdomen revealed evidence of acute pyelonephritis.   Upon admission, the patient was treated with high volume intravenous fluids, intravenous antibiotics, intravenous Protonix, and parenteral antiemetics and was kept nothing by mouth. Blood cultures were positive for E. coli. A unit of packed red blood cells was administered. An upper endoscopy revealed an esophageal ulcer, an ulceration at the gastrojejunostomy anastomosis, and a jejunal ulceration. The jejunal ulceration was clipped.
The patient continued to have melanotic bowel movements and the hemoglobin rose slightly to 10.6 g/dl. The blood pressure remained relatively low with systolics ranging 97-110. A liquid diet was added, and the patient continued to receive dual parenteral antibiotics and intravenous pantoprazole. When the patient was feeling better, there was no melena, and she was tolerating a diet and was discharged to home.

Based on a thorough review of the information provided, the acute inpatient stay was medically necessary for this patient. Upon presentation, there was objective evidence on physical exam, labs, and imaging of an imminently life-threatening cause of the patient's complaints. Specifically, the patient had credible evidence of a significant gastrointestinal bleed, hypotension, and tachycardia, along with gram negative sepsis from acute pyelonephritis. The services provided - intravenous antibiotics, intravenous hydration, other intravenous medications, and a blood transfusion - were at the acute inpatient level of intensity and were appropriately continued until the day of discharge. Therefore, based on the standard of care and peer reviewed literature, the acute inpatient level of care was medically necessary, and the patient could not have been managed at a lower level of care.