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

Diagnosis: Constipation predominant irritable bowel syndrome 
Treatment: Linzess

The insurer denied coverage for Linzess. The denial is overturned. 

This patient is a female child with a past medical history notable for seizure disorder, appendectomy and constipation predominant irritable bowel syndrome. According to her treating physician the patient's condition has failed to respond to all current FDA approved medications and is requesting Linzess. There are no details regarding prior assessments, imaging, prior treatments, adherence to treatment or clinical course. Her weight is 60.1 kilograms and her height is 165.5 centimeters. This patient has irritable bowel syndrome characterized by intractable constipation. By history she has tried and failed multiple traditional treatments without details submitted for review. Her treating gastroenterologist has prescribed Linzess to treat her condition (145mcg). 

In a review of the treatment of chronic functional constipation in infants, children and adolescents from UpToDate the author's review the pediatric experience with this agent as the following: "Newer pharmacologic agents - Newer drugs that are used for adults with chronic idiopathic constipation include the secretory agents linaclotide (Linzess), a guanylate cyclase receptor agonist, and lubiprostone (Amitiza), a chloride channel activator. One pediatric study reported that the side effects of lubiprostone were similar to those in adults, however, this study was not specifically designed to evaluate efficacy. Studies to evaluate efficacy of lubiprostone to treat functional constipation in children are ongoing. This trial can be accessed at the NIH website for ongoing clinical trials. 

These drugs are approved in the United States for chronic constipation in adults but are second-line agents (bulk-forming and osmotic laxatives are preferred). The authors conclude that linaclotide should be considered a potential pharmacologic agent for the treatment of intractable constipation in adolescents not responding to traditional interventions." There is a Black Box warning regarding the use of Linzess in children. Diarrhea is the most common adverse reaction; severe diarrhea reported in 2% of linaclotide-treated patients; instruct patient to stop therapy if severe diarrhea occurs and to contact healthcare provider; consider dose suspension and rehydration. 

For this particular patient the physiology of her response to Linzess should be no different now than in several weeks. The denial based on age alone is not substantiated and likely not in the best interest of this patient. 

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

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

Diagnosis:  Endocrine/Metabolic - Diabetes. 
Treatment:  Pharmacy Prescription drugs.  
The insurer denied medication Afrezza.  The denial is overturned.


The patient who has been diagnosed with type 1 diabetes since the age of 10 years.  The patient has been treated with multiple daily insulin injections.

The requested health service treatment of Afrezza is medically necessary for this patient.  Glycemic control is fundamental to the management of diabetes.  The Diabetes Control & Complications Trial (DCCT) study showed definitively that improved glycemic control is associated with significantly decreased rates of microvascular (retinopathy and nephropathy) and neuropathic complications.  As intensive diabetes management is associated with significantly decreased rates of microvascular and neuropathic complications, target HbA1C should be < 7% and achievement of HbA1C < 6.5%, if achieved safely without significant hypoglycemia, may be acceptable.

This patient has been diagnosed with type 1 diabetes, and control has been excellent; however, she has developed lipoatrophy associated with multiple daily insulin injections, so the patient is on inhaled insulin to minimize the number of injections that are medically necessary and reasonable, as the patient had developed lipohypertrophy from insulin injections, which ultimately led to lipoatrophy.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Psoriasis
Treatment: Taltz autoinjector 80 mg/ml Auto Injct 

Summary:
The patient is a male with psoriasis affecting 40% BSA (body surface area) for whom Taltz autoinjector 80 mg/ml Auto Injct  is requested. He has not used any therapies.

The current treatment guidelines, which are in accordance with nationally accepted standards of medical practice for moderate to severe plaque psoriasis, recommend typical first-line treatments, such as topical corticosteroids and calcipotriene, followed by typical second-line treatments, such as ultraviolet phototherapy, oral systemic treatments (methotrexate, cyclosporine) and biologics. After failure or contraindication to these treatments, newer agents for which less clinical experience and medical evidence exists, and that have not yet been incorporated into current treatment guidelines, such as Taltz, would be considered. 

The patient has no documented contraindications to the use of the preferred medications. Evidence from the peer-reviewed published scientific literature suggests that biologic and conventional systemic therapies are similarly safe and effective. Also, there is no evidence to support that Taltz is more efficacious in the treatment of psoriasis versus the alternatives. The patient has no documented contraindication to therapy with topical medications, phototherapy, conventional systemic medications, or biologics/small molecules on the formulary (Humira, Stelara, Enbrel, Otezla) in the medical records enclosed. Based on these reasons Taltz is not medically necessary, and the health plan should not cover the Formulary exception for Taltz.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Renal Colic 
Treatment: Acute Inpatient Stay 

The insurer denied acute inpatient stay. The denial was reversed. 

This is a female patient 34.6 weeks pregnant, with a history of ovarian cyst, nephrolithiasis, status post ureteral stents, and previous cesarean section. She presented to the hospital with complaints of left flank pain. The patient was consulted by Urology. The patient was medically managed with intravenous (IV) hydration, and pain medication. Surgical intervention was required; cystoscopy with retrograde pyelogram and insertion of ureteral stent was placed under spinal anesthesia. Fetal monitoring was maintained, no rupture of the membranes or cervical dilatation were noted; fetal station -4. Non-stress test (NST) was reactive; category I tracing. The patient was medically stabilized and discharged home. 

MCG guidelines list the following clinical indication for antepartum admission: Condition requiring premature delivery, Delivery, Fetal distress or demise, Preterm labor and positive fetal fibronectin (fFN), Significant maternal disease, infection or comorbidity as cause, Significant vaginal bleeding or any vaginal bleeding with known placenta previa, vasa previa or placenta accrete, Tocolytic therapy that requires inpatient care and Complications of tocolytic treatment 

The patient had a significant maternal disease. As explained above, urinary stones in pregnancy are considered a serious condition and management options are complex. Any procedure could lead to obstetrical complications, sepsis, and preterm labor. The patient was admitted for management. Initial management involved hydration and pain medication however, surgical intervention was required in this situation including spinal anesthesia. Following the procedure, both mother and fetus needed adequate monitoring. Only when both mother and fetus were judged to be stable was the patient discharged home. 

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

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

Diagnosis: Asthma
Issue under review: Inpatient admission

Determination:
The Inpatient admission was medically necessary.

The patient is a female child with medical history significant for moderate persistent asthma not well controlled (on Symbicort, Spiriva, and albuterol as needed) with multiple PICU (pediatric intensive care unit) admissions. She presented to the ED for the second time in the same day for respiratory distress. The day prior she developed rhinorrhea, cough, shortness of breath and wheezing. She was using nebulized albuterol at home without significant benefit. During the first ED presentation, she received three Duonebs and Decadron. Upon returning home, she became short of breath again and was taken back to the ED. 

The patient's vital signs included temperature 37.2, heart rate 150, respiratory rate 26 with 94% saturation in room air, and blood pressure 115/68. Examination was significant for tearfulness, retractions, speaking in short sentences, nasal discharge, moist mucous membranes, tachypnea, prolonged expiratory phase, wheezing, benign abdomen, and non-focal neurologic exam. Laboratory evaluation revealed normal WBC (white blood cell) count (9.10K) with 88% neutrophils, mild hyperglycemia (glucose 127), elevated AST (aspartate aminotransferase) (157), elevated alkaline phosphatase (469), negative rapid influenza and RSV (respiratory syncytial virus), and normal CRP (C-reactive protein). Venous blood gas was significant for pH 7.31 and pCO2 (partial pressure of carbon dioxide) 50.1. Chest x-ray showed no focal infiltrate, stable mild peribronchial thickening, and no pleural effusion. 

Despite treatment with three Duonebs, albuterol, magnesium sulfate, and normal saline bolus, the patient remained symptomatic. She was admitted for management of acute asthma exacerbation refractory to outpatient and ED (twice) treatment. Admission orders included IV fluids, regular diet, albuterol every three hours, enteral corticosteroids, and Pulmonology consultation. By the next day, she was able to tolerate lower dose albuterol every three hours. Pulmonology consulted, with recommendations to continue Spiriva and Symbicort, start Flonase daily, use a spacer with the breathing treatments, and follow-up with Pulmonology in one week. She was able to tolerate treatments every four hours and was comfortable with unlabored breathing. She was deemed stable for discharge to home. 

This child was admitted after presenting to the ED for the second time in one day following many bronchodilator treatments at home and in the ED, parenteral systemic corticosteroids, magnesium, and IV fluids. She failed appropriate outpatient treatment, necessitating acute inpatient admission for further care. She could not have been safely managed at a lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Impacted right upper canine
Treatment: D8080 - Comprehensive orthodontic treatment of transition dentition
D8760 - Periodic orthodontic treatment visits x4

The proposed treatment, D8080 and D8760, is medically necessary. The patient has an impacted upper right canine. This impacted permanent anterior tooth is an "automatic qualifier" according to the handicapping index scale. Having both upper canines in their proper position is critical in that these teeth help guide the lower teeth during the chewing cycle. Without the canines in their correct position, other teeth will not mesh properly and this can lead to the damaging of other teeth through grinding. The need for orthodontic treatment to correct this problem is medically necessary. The follow up visits are also medically necessary to make sure the treatment is working properly.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Abdominal pain
Issue under review: Inpatient admission
The insurer denied the inpatient admission.
The denial is overturned. 

The patient is a male child with medical history significant for prematurity born at 35 weeks' gestation and chronic constipation that was referred to the ED by Urgent Care with two-week history of mucous in his stools, vomiting one week prior, two days of intermittent abdominal pain, and one-day history of bright red blood per rectum, fever to 101, poor oral intake, increased abdominal pain, and decreased wet diapers.

Vital signs in the ED included temperature 98.3, heart rate 128, and respiratory rate 30. Examination was significant for distress during examination, moist oral mucosa, clear lungs, soft non-tender abdomen with no palpable masses, normal bowel sounds, no anal fissures, good perfusion, and non-focal neurologic exam. Bedside ultrasound was performed to evaluate for intussusception and was negative, so was followed by formal ultrasound revealing transient small bowel/small bowel intussusception in the left upper quadrant. 

Laboratory evaluation revealed mild metabolic acidosis and unremarkable CBC. Chest x-ray was normal. Abdominal x-ray revealed a non-obstructive bowel gas pattern. Fleet enema was performed with successful passage of stool. He was treated with an IV fluid bolus and a dose of morphine. Because of persistent abdominal pain, he was admitted for further management. 

Admission orders included stool studies, GI and Surgery consultations, Tylenol as needed, nothing by mouth, and IV fluids. Surgery recommended contrast enema that was suspicious for Hirschsprung's disease, so suction biopsy was performed to rule out Hirschsprung's disease. He did well following the biopsy and was able to eat. GI recommended work-up for celiac disease and thyroid studies. He was deemed stable to discharge home to follow-up with both Surgery and GI in the outpatient setting. Following discharge the biopsy results returned normal with no evidence of Hirschsprung's disease.

Yes, the Inpatient admission is "medically necessary".

This young child with history of prematurity and severe chronic constipation refractory to aggressive medical management presented with acute onset of abdominal pain and bloody stools. Imaging was suspicious for transient intussusception. Despite resolution, he continued to experience severe abdominal pain, so further work-up was undertaken, suspicious for Hirschsprung's disease. He underwent rectal suction biopsy as well as bowel clean-out. Upon resolution of pain and demonstration of adequate oral intake, he was discharged home. Biopsy results were ultimately negative. Because of the complicated nature of his presentation, initially with concern for intussusception and then with concern for Hirschsprung's disease, both situations necessitating expert consultation and diagnostic studies, acute inpatient admission was medically necessary and appropriate. This level of complexity and care cannot be safely managed at a lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Coronary artery disease, hypertension, congestive heart failure.
Treatment: Personal care aide.
The insurer is denied coverage for personal care aide (PCA).  The denial is reversed. 

The patient is a male with a history of coronary artery disease (CAD), hypertension (HTN), congestive heart failure (CHF), PTCA, osteoarthritis (multiple sites), impaired balance, frequent falls, constipation, benign prostatic hypertrophy (BPH), carotid artery stenosis, gastroesophageal reflux disease (GERD), gastritis, depression, insomnia, dyslipidemia.  It was reported that the patient lives alone and is non-ambulatory.  His physical and mental condition had deteriorated rapidly over a month's time, and he has become completely disoriented at night.  He requires repositioning in bed every 2 hours and frequent diaper changes.  He has a history of falling out of bed and has later been found when the PCA arrives in the morning.  Due to COVID-19, telephonic UAS was conducted.  He is completely dependent on caregivers for all his needs day and night.  The son was advised, and he considered bringing his father to a hospital but not during COVID-19 pandemic, as it would increase his chance of infection and or death.  The son feels that each night his father spends alone is not safe.  The physician strongly recommends the patient to have assistance 12/12 hours, 7 days per week, split shift.

Considering the patient's care needs, including assistance when he attempts to get up from bed at night, incontinence care throughout the day and night, and repositioning in bed on a regular basis (every 2 hours as per physician's note), it does not appear that a live-in aide would have at least 5 uninterrupted hours of sleep each day, which is required by NYS regulations for a live-in aide.  Therefore, it is medically necessary for the patient to have 24 hour continuous PCA services, as two 12 hour shifts.

Personal Care Aide Level 2: 12 hours per day, 7 days per week; 12 hours per day, 7 days per week (split shift) - total of 168 hours per week is medically necessary.

The carrier's denial of coverage for Personal Care Aide (PCA) Level 2: 12 hours per day - 7 days per week; 12 hours per day - 7 days per week (split shift) - for total of 168 hours per week is reversed.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis Ovarian Torsion
Inpatient Hospital Stay
The insurer denied the Inpatient Hospital Stay
The determination is upheld.

The patient was pregnant  and was admitted to the inpatient service secondary to abdominal pain. She was seen in the emergency room for right lower quadrant pain and vomiting. The diagnosis was possible ovarian torsion. She had a right laparoscopic salpingoophorectomy and dilation and curettage for a 6 centimeter (cm) hemorrhagic right ovarian cyst that was torsed. She was discharged home. At issue is  the medical necessity of the inpatient hospital admission.

The inpatient stay was not medically necessary for this patient.
The patient was a young and healthy female with no comorbid medical conditions. She had an ovarian torsion and had an outpatient uncomplicated procedure for this. Her vital signs were stable and she had no evidence of an elevated temperature or infection. She had no complications from surgery and no excessive blood loss. She had no hemodynamic instability. She had no abnormal laboratory tests nor anesthesia complications. The surgery length was not excessive. There is no documentation that supports the need for inpatient monitoring and the patient was discharged after surgery, doing well. She could have obtained her surgery and then been monitored at a lower level of care. She could also been treated at a lower level of care prior to surgery. There is no reason that the patient warranted inpatient acute care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Arthritis
Treatment: Hyaluronic acid injections for the knees
The insurer denied the Hyaluronic acid injections for the knees. 
The denial is upheld. 

No, the proposed treatment, Hyaluronic acid injections for the knees, is not "medically necessary."

This is a female who suffers from MS (multiple sclerosis). She had balance issues and bilateral knee pain. She also has a blood clotting disorder. She had been diagnosed with osteoarthritis and had received viscosupplementation in the past. Additional injections have been recommended. She recently walked 10 miles and developed knee pains.

The use of viscosupplemenation has been proposed to reduce pain and increase function in osteoarthritic joints. There is lack of proteoglycans and water content. This is secondary to wear and loss of articular cartilage. Instillation of chondral building blocks (viscosupplementation, proteoglycans, natural or synthesized in lab) has been utilized to restore damaged joints. It has not been shown that these injections have worked as reported by several meta-analysis.  

The scientific literature had recommended viscosupplementation for the treatment of osteoarthritis if all other courses failed prior to surgery. 

The recommendations for use of Viscosupplementation have changed. 

A review of the Clinical Practice Guideline by AAOS cites:

The 2013 OA knee treatment CPG contains one significant recommendation change from the 2008 CPG, and this is with regard to the issue of viscosupplementation. The 2008 OA knee CPG included an "inconclusive" recommendation regarding the use of intra-articular hyaluronic acid (HA) injections that was largely the motivating factor for the expedited update of the CPG.

The second edition CPG recommendation reads "We cannot recommend using hyaluronic acid (HA) for patients with symptomatic OA of the knee," with a "Strong" rating, based on supporting evidence from 3 high-quality and 11 moderate-quality research studies that met the inclusion criteria.

The work group understands the potential impact that this recommendation could have on clinical practice. Nonetheless, the CPG's best evidence synthesis does not support the efficacy of viscosupplementation. Although statistically significant outcomes were seen in some studies with higher molecular weight HA preparations, these outcomes were not clinically significant, based on a lack of minimum clinically important improvement (MCII). (For more information on MCII, see "The Importance of Clinical Significance in AAOS CPGs," AAOS Now, May 2013.)

The Orthopedic group reports "strongly do not recommend use."

The denial would thus be appropriate and consistent with current practice.