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

Diagnosis: Small fiber neuropathy
Issue under review: IVIG

Determination:
The health plan should not cover the IVIG.

The patient is an adult who was diagnosed with mild sensory neuropathy, and a diagnosis of small fiber inflammatory polyneuropathy was subsequently made and confirmed on biopsy. 

Gabapentin caused intolerable side effects, and attempts at getting approval for IVIG (intravenous immunoglobulin) therapy were unsuccessful.  The patient's symptoms include fatigue, leg/arm weakness, persistent "electrical pulses" in his legs as well as numbness and pins-and-needles sensation.  

The patient was prescribed prednisone and a trial of duloxetine.  Immunosuppressant treatments were to be considered.  

As of a follow-up, the patient reported excellent results from prednisone but was concerned regarding long-term side effects. Duloxetine had not provided any benefit. The patient was advised to start on a trial of mycophenolate mofetil.  The physician noted the patient might require a trial of IVIG therapy.  

During follow-up, it was noted the patient was unable to tolerate mycophenolate mofetil even at a reduced dosage, and that it was not helpful in any case. The patient reported that "neuropathy is throughout my whole body."  The patient was referred for IVIG therapy. 

There are no double-blind placebo-controlled randomized studies to indicate that intravenous immunoglobulin is more efficacious or safer in the management of small fiber neuropathy comparing to steroids. Steroids are considered to be the standard of care for autoimmune variety of small fiber neuropathy. The patient was previously tried on steroids and had to good effect without any side effects reported. The patient was not reported to be at high risk for complications of the steroids, such as having hypertension, diabetes, metabolic syndrome or obesity. Therefore, in the patient's case, the intravenous immunoglobulin requested is not expected to be more beneficial than standard treatments for this condition available, as above.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Skeletal Class II Malocclusion; Maxillary and Mandibular Crowding; deep Impinging Overbite and Excessive Overjet. 

Treatment: D8080 braces

The insurer denied the D8080 braces. The denial was reversed.   

This male patient presented for an orthodontic evaluation. Diagnostic imaging was performed that included cephalometric radiograph, panoramic radiograph, and montage of extraoral and intraoral clinical images. It was determined that the patient had skeletal Class II malocclusion, maxillary and mandibular crowding, deep impinging overbite and excessive overjet. HLD index was completed and recommendations for orthodontic treatment were made.

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.  This is confirmed by several studies. Each of the 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.

It is evident that the patient exhibits a significant malocclusion.  However, to assess for severity of the malocclusion and therefore medical/dental necessity for orthodontic care, the use of a Handicapping Labiolingual Deviation Index is utilized. 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 of 26 points is necessary. 

In this case, the treating Orthodontist claims an automatic qualifying condition of deep impinging overbite with severe soft tissue damage.  The reviewer finds that this automatically qualifying condition criterion is met and does support comprehensive orthodontic care.  In this case, the clinical circumstance does meet insurer and plan criteria to justify orthodontic care. 

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

Based on the above, the medical necessity for D8080 braces is substantiated. The insurer's denial is reversed.
Appeal type: Medical necessity
Decision: Overturned

Cancer
Home Health Care

The patient is a female with past medical history of non-Hodgkin's lymphoma, dementia, bowel and bladder incontinence, chronic obstructive pulmonary disease (COPD), hypertension, hyperlipidemia and gait abnormalities who had been assigned personal care aide (PCA) services of 12 hours/day, 7 days/week to total 84 hours/week based on assessment tool performed in the summer. The patient lives alone and her daughter lives 3 hours away. The patient was hospitalized in the fall with hypercapnic respiratory failure secondary to post obstructive pneumonia with probable recurrence of non-Hodgkin's lymphoma. The patient was discharged to home with hospice and continuation of oxygen and bi-level positive airway pressure (Bi-PAP). The patient required Hoyer lift for transferring. The patient also had a pressure sacral ulcer 7 x 5 centimeter (cm). The patient was unable to ambulate and was essentially bedbound. The family requested an increase in PCA services to 2-12 hour split shifts/day, 7 days/week to total 168 hours per week. The patient subsequently had another assessment tool performed more recently showing a change from maximal dependence to total dependence for walking, bed mobility, eating and managing medications. The patient remained total assistance for meal preparation, ordinary housework, managing finances, shopping, equipment management, bathing, personal hygiene, dressing upper extremity/lower extremity (UE/LE), locomotion, transfer toilet and toilet use. Patient's PCA service hours remained at 12 hours/day, 7 days/week to total 84 hours/day. A note from primary care physician (PCP) indicated the patient was bedbound, oxygen dependent, non-ambulatory and needed to be repositioned every 2-3 hours due to sacral ulcer discomfort. The patient's advocate provided a summary of the patient's status and need for PCA services, including night log for several weeks in November and December showing overnight needs for the patient.

The health plan's determination is overturned.

Yes, the requested personal care services to 24 hours, 7 days a week (split shift) is medically necessary for this patient.
The patient had a significant change in status following her hospitalization in the fall. The patient requires frequent repositioning due to her status, pain and sacral ulcer, at least every 2-3 hours, including overnight. The patient lives alone. The patient's daughter lives 3 hours away. The patient has documented change in the most recent assessment tool. The patient's PCP noted re-positioning every 2-3 hours was medically necessary as was an increase in personal care aide services to 24 hour care in split shifts.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Constipation
Relevant Past History: Spinal stenosis
Issue Under Review: Inpatient admission
Summary: No, the inpatient admission was not medically necessary
The treatment as provided was medically appropriate but the level at which the care was provided was not medically necessary. The entirety of the care could have been delivered at a lower level.
Despite the patients presentation, the care as provided could have been rendered in its entirety at a lower level of care. The patient had an infection; yet she did not evidence a change in mental status, high fevers, neurologic changes, hypotension, signs of sepsis, hemodynamic changes, renal abnormalities, need for nothing by mouth (NPO) status, need for invasive surgery, need for invasive monitoring or treatments, severe electrolyte dyscrasias or any other indication for an acute admission.  As such the care could have been rendered at a lesser level.
Appeal type: Medical necessity
Decision: Upheld

This patient has a history of colon cancer. The patient reported having chemotherapy the day prior to hospital presentation and Neupogen the day of presentation. The patient presented to the emergency room with subjective fever and chills x1 day.  Associated with chronic non-bloody diarrhea and a sensation of phlegm in the chest but the patient was unable to clear the phlegm out or cough. Laboratory testing revealed potassium was 3.7, sodium of 139, glucose of 139, hemoglobin and hematocrit of 12.2/35.6 and the urinalysis was negative. The patient's white blood cell count was high at 30.7. The oncologist stated that 24-48 hours after Neupogen injection, labs and symptoms can mimic acute infection, including leukocytosis and sensation of subjective fever and chills; she reported that blood cultures are typically followed to determine if the patient has an infection or not. The physicians rationale for admission was a white blood cell count of 30.7. It was thought most likely to be an adverse effect of Neupogen, but needed to rule out infection. Blood cultures were sent to the lab and the patient was started on intravenous antibiotics. 

The insurer denied coverage for the inpatient hospital services. The decision was upheld. 

The Milliman Care Guidelines list general admission criteria including hemodynamic instability, hypertension requiring inpatient treatment, abdominal abnormalities with absent bowel sounds with complete ileus, signs of intestinal obstruction or peritonitis, vomiting that is severe or persistent. The white blood cell count was 30.7. However, the oncologist stated that, 24-48 hours after Neupogen, a patient could have symptoms that mimic an acute infection. The documentation of the patient's condition does not meet the criteria for an inpatient admission. The patient could have been treated in an observation level of care.
Appeal type: Medical necessity
Decision: Overturned

This patient has a history of asthma and has had three previous asthma admissions to the hospital. He was coughing and wheezing and was seen in the Pediatricians office on the day prior to admission. The Pediatrician prescribed albuterol at home every 4 hours which the mom administered overnight but when the patient did not improve she took him to the hospital for an evaluation. In the emergency room, the patient was noted to be in moderate respiratory distress with tachypnea with a respiratory rate of 50, wheezing, grunting and retractions. The patient was treated with frequent treatments with bronchodilators, prednisone, a normal saline intravenous bolus and intravenous magnesium sulfate. The patient was then treated with continuous administration of albuterol and was started on oxygen supplementation. When the evidence of increased respiratory effort and retraction persisted despite treatment the decision was made to admit him to the hospital with a diagnosis of status asthmaticus.

The insurer has denied coverage for the inpatient hospital services. The denial was reversed. 

According to UP TO DATE: Acute asthma exacerbations in children: Emergency department management, Hospitalization  Patients who were moderately to severely ill on arrival and who have little improvement after initial therapy with beta agonists and systemic glucocorticoids require hospitalization. This includes patients who continue to have significant wheezing and retracting, poor aeration, or altered mental status, such as drowsiness or agitation. The patient was treated appropriately in the emergency room for status asthmaticus. The decision to admit him to the hospital with a diagnosis of status asthmaticus for ongoing treatment with albuterol every 2 hours and steroids was consistent with the standard of care for a child of this age, with status asthmaticus with persistent respiratory distress.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Angina
Treatment: Inpatient admission
The Inpatient admission was not medically necessary.

The patient is a male. He presented with fatigue, dyspnea and palpitations. He has history of CVA (cerebrovascular accident), hypertension, diabetes, and hyperlipidemia. He also has history of solitary kidney with creatinine of 1.6. 

A stress test was performed and showed mild anterior wall ischemia. The patient's EKG (electrocardiogram) was normal. Creatinine was 1.52 after hydration with elevated HgB A1c (glycated hemoglobin). 

The patient was admitted to telemetry, and he underwent an angiogram with PCI (percutaneous coronary intervention).  OM1 (obtuse marginal branch OM1) was stented with a 2.25 x 15 DES (drug-eluting stent). Indications were positive stress test without unstable angina per intake.  

Post cath, the patient received IV fluids, and the access site was stable.  Routine post PCI medications were given. He was discharged after a one night stay. 

This patient was admitted following a positive stress test performed because of atypical symptoms. This led to an uncomplicated cardiac Cath and placement of a 2.25 stent in a small OM. 

Determination of level of care is primarily dependent on the actual care a patient receives, and whether a higher level of acuity is needed to give this care. This is best reflected in the presentation, physical exam findings, and laboratory orders and their results; and highlighted in the orders for care. In this case, the symptoms were atypical and unlikely to be representative of acute coronary syndrome (ACS). The attending specifically did not check ACS in chart. Exam and cardiac findings were normal.  EKG was normal.  Orders did not include medical therapy for ACS, such as IV heparin, dual antiplatelet inhibitors, high dose beta blockers or IV NTG (nitroglycerin).  While the patient had an elevation of creatinine and one kidney, this was previously known and treated successful with simple hydration.
 
The letter of appeal was carefully considered, but offered no evidence to support inpatient level of care. The only cardiac care that was provided was telemetry, which is frequently performed in a lower level of care. The patient was admitted for monitoring, and the subsequent tests and therapy did not require an inpatient level of care. Community protocol and guidelines often recommend same day discharge for an uncomplicated procedure. An overnight stay does not change the level of care. All of the testing and therapy that were provided would have been appropriate, safe and guidelines-consistent in a lower level of care. Thus, inpatient level of care was not medically necessary.

Milliman criteria requirements were not fulfilled, as there was never any evidence of ACS present.

The denial explanation was consistent with guidelines and usual community care.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #3: 

This is a patient with a diagnosis of adenocarcinoma of the lung. Tissue samples were sent to be analyzed for actionable genes using FoundationOne. 

The scientific evidence in peer reviewed literature supports a report of improvement in health outcomes through comprehensive molecular characterization of lung adenocarcinoma. (Jordan EJ, Kim Hr, Arcila ME, et al. Cancer Discovery. 2017. June 7(6) 596-609). In addition, NCCN guidelines support its use. The FoundationOne CDX test is FDA approved for non-small cell lung cancer as of November 30, 2017. The patient is a good candidate for genetic testing and it is the best available diagnostic test for this patient. The requested service is likely to be more beneficial to the patient than any of the standard treatments. 

The carrier's denial of Genetic testing 0037U should be reversed.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer # 2:

This is a male patient with mediastinal lymphadenopathy and brain metastasis. He had a needle biopsy of a lymph node and the material was sent for genetic testing. 
The use of genetic testing is appropriate. Molecular testing can accurately identify the tissue of origin and subsequently guide site-specific therapy in patients with carcinoma of unknown primary (CUP). The diagnostic efficacy is based on distinct gene expression profiles present in different normal body tissues. When cancers arise from normal tissues, the distinct gene expression profiles are usually retained, at least in part, by the neoplastic cells, allowing identification of the tumor site of origin (e.g., primary site). Several using either reverse transcription polymerase chain reaction (RT-PCR) or gene microarray technology, are commercially available and provide results with a clinical turnaround time of approximately one to two weeks. Based on clinical validation studies, these assays can correctly identify the primary site in 85 to 95 percent of metastatic cancers from various known primary sites and in the large majority of carcinoma of unknown primary. 

Per Binder, C., Matthes, K. L., Korol, D., Rohrmann, S., & Moch, H. (2018), "Age-standardized incidence rates [ASR] of CUP increased from 10.3 to 17.6 between 1981 and 1997 and decreased to 5.8/100,000 in 2014. Mean overall survival remained stable. Mortality was significantly lower for patients with squamous cell carcinoma (HR 0.48 [95% CI, 0.410.57]) and neuroendocrine carcinoma (0.75 [0.630.88]) and higher for unclassified neoplasms (1.25 [1.131.66]) compared to adenocarcinomas. The literature review identified 10 studies using comprehensive genomic profiling [CGP] of CUP tissue. Clinically relevant mutations were identified in up to 85% of CUP patients, of which 13%64% may benefit from currently available drugs."

Per Hemminki, K., Chen, B., Kumar, A., Melander, O., Manjer, J., Hallmans, G., Forsti, A. (2016), "Recent mutational screening and genome-wide sequencing efforts have revealed frequent alterations in the receptor tyrosine kinase/Ras signaling pathways allowing possibilities for targeted therapies [16-18]. Hardly any data are available of germline variants that might predispose to CUP. In view of the familial clustering of CUP with other primary cancers, pointed out above, it could be speculated that some of the susceptibility genes for these primary cancers may also predispose to CUP." 

The carrier's denial of Genetic testing 0037U should be reversed.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Mild decompensated CHF in setting of asthma exacerbation
 
Treatment: Inpatient admission

The insurer denied coverage for inpatient. The denial is upheld. 

This patient is a female with history of asthma, chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), cerebrovascular accident (CVA), diabetes mellitus (DM), obstructive sleep apnea (OSA), congestive heart failure (CHF), hypertension (HTN), and hyperlipidemia (HLD) who presented to the Emergency Department (ED) with complaints of shortness of breath (SOB) and chest tightness.

The patient had elevated blood pressure (BP) to 199/121, and respiratory rate (RR) 22.  Lung exam revealed bilateral wheezing.  Cardiovascular system CVS S1 S2 was normal (N).  Pedal edema 3+ is noted. The patient had mild elevation of Troponin.  BUN/Creatinine was 32/1.8.  White blood cell (WBC) count was mildly elevated to 11.7 K. She was treated with continuous positive airway pressure (CPAP), aspirin (ASA), Lipitor, Lasix, Spirinolactone, and Levaquin.  The patient also received treatment for asthma with nebulizers, steroids, LABA/ICS and long-acting muscarinic antagonists (LAMA).

The patient did improve with treatment.  Myocardial infarction (MI) was ruled out.  Blood pressure was controlled.  By the next day the patient felt better and signed out against medical advice (AMA).

This patient did not need acute inpatient hospitalization.  The patient had mild decompensated CHF in setting of asthma exacerbation.  The patient responded well to treatment.  She remained afebrile and blood pressure improved.  The patient also improved with treatment in the ED.  The patient could have been placed in Observation status while diagnostic testing and treatment were initiated.

The patient was tolerating oral intake (PO).  She was stable to be discharged on PO meds and bronchodilators after a period in observation status.  MI was ruled out.  Pedal edema and congestive heart failure improved with diuresis.  This patent did not need acute inpatient hospitalization.  

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

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

Diagnosis: Diarrhea, abdominal pain and vomiting
Treatment: Inpatient admission
The proposed acute level inpatient care for the management of this patient was not appropriate or medically necessary. 

The patient is a female with hypertension, type II diabetes mellitus, hyperlipidemia, and recurrent urinary tract infection (UTI).  She was recently treated with Cipro for UTI. She presented to the emergency department (ED) with abdominal pain, nausea, vomiting and diarrhea of a few days duration.  She also had fever of 102F. 

In the ED, the patient was evaluated and underwent computed tomography (CT) scan of the abdomen which revealed thickening of the cecum consistent with (c/w) colitis and surrounding adenopathy. Her abdominal examination was remarkable for right lower quadrant tenderness but no rebound. The stool studies were obtained and she was admitted to the hospital for the management of possible infectious colitis.

The patient was started on intravenous (IV) fluids, IV ceftriaxone, Flagyl, and Zofran IV for nausea and vomiting. Her complete blood count (CBC) on admission was normal and comprehensive metabolic panel (CMP) revealed normal lytes except for borderline sodium (Na) of 134 and mildly elevated blood urea nitrogen (BUN) and creatinine of 26 and 1.3, respectively. The patient was started on clear liquids which she tolerated well. She responded well to the fluids and antibiotics and her renal functions normalized and her diet was advanced to diabetic diet. She was discharged home on five days of antibiotics including cefdinir and Flagyl.

The patient presented with a three- to four-day history of abdominal pain, nausea, vomiting and diarrhea and was diagnosed with right-sided colitis. She was mildly dehydrated with mildly elevated BUN/creatinine which resolved after appropriate hydration.  The patient was empirically started on broad spectrum antibiotics to which she responded to very well. She was able to tolerate clear liquid diet on the day of admission and the diet was gradually advanced without any recurrence of nausea or vomiting. Her diarrhea resolved in the hospital. She was discharged home in a fair and stable condition. 

Given this clinical course, the patient could have been safely and appropriately managed under a lower level of care and the acute level of care was not medically necessary.   The patient had no signs of peritonitis, bowel obstruction, sepsis, or gastrointestinal (GI) bleed to warrant any endoscopic or surgical intervention.