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

Diagnosis: IBS (irritable bowel syndrome) and constipation.
Treatment: Formulary exception for Chlordiazepoxide-Clidinium.

The insurer denied the Formulary exception for Chlordiazepoxide-Clidinium. The denial is overturned. 

Yes, the health plan should cover the Formulary exception for Chlordiazepoxide-Clidinium. 

The patient is a female with IBS (irritable bowel syndrome) and constipation. She has failed treatment with Bentyl (dicyclomine), as well as Cipro and Flagyl. 

In order for criteria for Chlordiazepoxide-Clidinium to be met for the treatment of IBS, the patient must have failed the preferred formulary alternative dicyclomine. The patient has failed treatment with Bentyl (dicyclomine), as well as Cipro and Flagyl. 

Chlordiazepoxide-Clidinium is a safe an effective treatment for IBS. The patient has failed the health plan's formulary alternative of dicyclomine. Therefore, the health plan should cover the Formulary exception for Chlordiazepoxide-Clidinium.
Appeal type: Medical necessity
Decision: Upheld

Digestive System/Gastrointestinal
Inpatient hospital 

Diagnosis: Abdominal pain
Treatment: Inpatient stay
The insurer denied the inpatient stay. The health plan's determination is upheld. 

The patient is a female with left lower quadrant pain who presented to the emergency room. She had a history of multiple admissions for recurring symptoms. Vital signs were stable. Computed tomography (CT) scan showed a 1.5 centimeter (cm) ovarian cyst. She was admitted as an inpatient for possible surgical intervention; however, no surgery documentation was provided. She received pain medication and intravenous fluids. She was discharged the following day.

The Inpatient Hospital Admission is not medically necessary for this patient. The patient had abdominal pain, however, she was hemodynamically stable and vital signs were stable. She had no signs of infection, electrolyte imbalance or severe anemia. She was scheduled for surgery; however, she changed her mind. She had no comorbidities that required an inpatient hospital admission. She was given no treatment nor therapy that required acute inpatient monitoring. She had a small ovarian cyst that could have been monitored and/or managed as an outpatient. If monitoring was required, this too could have been performed in the emergency room or at a lower level of care.
Appeal type: Medical necessity
Decision: Upheld

Digestive System/Gastrointestinal
Pharmacy/Prescription Drugs

Diagnosis: irritable bowel syndrome 
Treatment: Linzess
The insurer denied Linzess. 
The health plan's determination is upheld. 

This patient is a female with a history of irritable bowel syndrome with constipation (IBS-C). She has tried and failed numerous therapies, including Miralax, fibers, Senna and dietary changes. The requested service is Linzess. 

Linzess is not medically necessary for this patient. Linzess is Food and Drug Administration (FDA) approved for the treatment of irritable bowel syndrome with constipation and for chronic constipation in adults. The safety and efficacy of Linzess in pediatric patients has not been established.
Per Di Lorenzo, Carlo, et al: in children with constipation, no clear improvement over placebo was observed for Linzess.
Linzess is currently undergoing a clinical trial to assess its safety and efficacy in pediatric patients and to identify the proper dosing. No conclusion can be made from this study as the results are not published yet. There is no other supportive studies for using Linzess in children.
Given the lack of adequate scientific support for using this medicine in children, it cannot be considered medically necessary. Other medications have been better evaluated for treating children, such as Amitiza.
Therefore, Linzess is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Digestive system/gastrointestinal/Gall bladder problem  
Treatment: Inpatient hospital 
The insurer denied the inpatient hospital stay. 
The denial is upheld in whole .

The patient who presented to the hospital with abdominal pain in the setting of known gallbladder disease. The patient has a history of prior pulmonary embolism and was being treated with Lovenox anticoagulation.
The inpatient stay is not medically necessary for this patient. There is no clinical documentation to support the need for inpatient admission  or why this patient could not have safely and appropriately been treated at a lower level of care. Based on the submitted clinical documentation, an inpatient level of care was not medically necessary. There is no documentation of hemodynamic, pulmonary, neurological, or metabolic reason for an acute inpatient level of care. 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. 
Generally accepted practice standards support that a reasonable and appropriate goal length of stay for cholecystectomy, as in this case, is at a lower level of care or 1 day postoperative.  These standard guidelines support that in the absence of hemodynamic instability, sepsis or toxicity, significant electrolyte imbalance, bleeding, Gastro-intestinal (GI) obstruction or surgical complications, the procedure may be performed with a lower level of care.  In this case the patient tolerated oral hydration, diet and medication and pain was well controlled.  A lower level of care would have appropriately provided for presurgical assessment, laparoscopic cholecystectomy, and post-surgical monitoring.  Inpatient care was not required or medically necessary in this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Lymphedema 
Issue under review: Pneumatic compression device and garments 
The insurer denied the pneumatic compression device and garments.
The denial is upheld.

The patient is a female. The patient has been using Flexitouch to treat bilateral leg swelling. Her symptoms were not responsive to compression stocking therapy.

No, the Pneumatic compression device and garments are not medically necessary.

In order to evaluate the medical necessity of Flexitouch in this case, the relevant peer-reviewed literature on the matter of pneumatic pumps for leg swelling due to lymphedema and/or venous insufficiency will be evaluated. 

The appeal letters state that Flexitouch is medically necessary, but the basis for the conclusion is that the patient has benefited from use of the device. However, this is a flawed, circular argument. Medical necessity is established not on the basis of patient's response to a particular treatment, but based on the patient meeting accepted criteria for employing a particular therapy. The appeal letters do not indicate that the patient met the above criteria prior to initiation of Flexitouch.

Based on the above discussion, it is concluded that Flexitouch is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Right leg cellulitis 
Treatment: Inpatient admission 
The insurer is denied coverage for inpatient admission. 
The denial is upheld. 

The patient was a male with past medical history significant for hypertension and varicose veins who presented to the Emergency Department (ED) with complaints of right lower extremity pain and swelling. The patient's vitals on presentation included: temperature 98.9 F, blood pressure176/89, heart rate 95, respiratory rate 18, and oxygen (O2) saturation 100% on room air. The patient's laboratory results included the following: white blood cell (WBC) count 10.45, hemoglobin 13.5, hematocrit 42.1, creatinine 0.72, glucose 102, CRP 252, and ESR 81. The patient was started empirically on intravenous (IV) fluids and antibiotics (i.e., cefazolin) for lower extremity infection. The patient's x-ray showed some soft tissue swelling, but no fractures, no foreign body, no evidence of osteomyelitis. The patient's Doppler ultrasound showed subcutaneous edema, and right inguinal lymph node swelling, but no evidence of deep venous thrombosis (DVT). The patient's blood cultures remained negative. The patient received Toradol for pain. The patient remained afebrile and hemodynamically stable. The patient was discharged with instructions to continue taking oral antibiotics as an outpatient. 

Based on the review of the medical record and the literature, inpatient admission was not medically necessary. The patient presented to the hospital with a right leg cellulitis and onychomycosis of his toes. Otherwise, the patient was afebrile, hemodynamically stable with unremarkable laboratory results including a normal WBC. The patient did not have any evidence for a disseminated infection, and did not have a clinical condition that required surgical intervention. The patient was able to tolerate oral intake. The patient could have been discharged home with oral antibiotics and close follow-up as outpatient. 

The health plan acted reasonably with sound medical judgment, 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: Upheld

Central Nervous System/Neuromuscular
Nursing Services (including Private Duty Nursing)

Diagnosis: Dementia
Treatment: Personal Care Aide (PCA) Services
The insurer denied the Personal Care Aide (PCA) Services: Live-In Per Diem [24 Hours per Day/7 Days per Week]. The health plan's determination is upheld. 

The patient is a female with past medical history significant for dementia secondary to vascular disease without behavioral problems. The patient is wheelchair bound. Other medical problems include depression, cerebrovascular disease, urinary tract infection, diabetes mellitus and hypertension. The patient requests personal care services 24 hours a day 7 days a week by live-in. The health plan has approved personal care aide level 2: 8.5 hours per day - 7 days per week for a total of 59.5 hours a week.

The Personal Care Aide (PCA) Services: Live-In Per Diem [24 Hours per Day/7 Days per Week] is not medically necessary for this patient. The patient's abilities to perform her physical function such as daily activity stayed the same including dressing upper body and lower body, personal hygiene, bed mobility, walking bathing, transfer and toilet, toilet use, meal preparation, medication management and order any housework. Abilities which declined include eating. In specific, the Uniform Assessment System (UAS), did not support the need for nighttime hours. In summary, there is no medical necessity for additional services beyond what is already being provided. There was some urinary incontinence noted, but no bowel incontinence. There was no noted need for frequent turning at night such as wound care issues or other medical problems.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gynecological
Treatment: Inpatient Hospital
The insurer denied: Inpatient Admission
The denial is: Overturned in whole

A gravida 4 para 1 at 24 weeks estimated gestational age presented to the hospital with a severely shortened cervix (1.5 centimeter long) and dilation of about one half centimeter. She was admitted and had cerclage placed late that night. She also completed antenatal steroids for fetal lung maturity. She was assessed as stable and discharged.
The subject under review is the medical necessity for the inpatient admission.

The health plan's determination is overturned, in whole.

Inpatient admission was medically necessary for this patient with a high risk of preterm delivery. This is a perilous presentation where the only course of care is inpatient admission for monitoring and steroids. At the time of her presentation, with a cervical length of 1.5cm, there was very real concern for this patient delivering. Because of the high risk of preterm delivery, the patient required admission where parenteral steroids could be administered, and the patient could be monitored for contractile activity. A rescue cerclage was placed, which is very dangerous at this advanced gestational age and would traditionally be followed by monitoring for infection, labor, or ruptured membranes. Indeed, this patient did at one point have a gush of serosanguinous fluid concerning for ruptured membranes and required further evaluation to assure her membranes were intact.  At 24 weeks that delivery would carry high risk of death or disability. Aggressive management and availability of resources for a 24 week delivery were key in this situation, and not available at a lower level of care. The inpatient admission is necessary because of the risk of delivery, and not the procedure. Most cerclages are placed as an outpatient, in a prophylactic manner at about 13 weeks gestational age. Those procedures are low risk and require little recovery. A rescue cerclage, on the other hand, is performed at the brink of viability and in the face of an already shortened cervix. Such a procedure is risky and generally only performed on patients already inpatient for threatened premature labor. Up-To-Date, a common physician reference, specifically states a longer period of inpatient monitoring is needed for rescue cerclage (like this patient) because of the higher likelihood of complications. This patient was admitted because her cervix was shortened on ultrasound and dilated on exam, suggesting a 24 week delivery was a very real possibility. Monitoring, parenteral steroids, and Neonatal Intensive Care Unit (NICU) standby are resources that cannot be provided at home, therefore inpatient admission was medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Gastrointestinal Bleeding
Treatment: Inpatient stay.
The insurer denied the inpatient stay. The health plan's determination is upheld. 

This is the case of a patient with history of acute lymphocytic leukemia as a child in addition to schizophrenia versus bipolar disorder who presented with an episode of bloody stool noted on the toilet paper in addition to right frontal-lateral neck pain for the prior 4 weeks. He additionally noted a 20 pound weight loss in the past three weeks. On presentation, he was afebrile with blood pressure 114/75, heart rate 99, respiratory rate 18, and with oxygen saturation 97% on room air. Orthostatic vital signs were noted to be unremarkable. Exam otherwise noted no blood on digital rectal exam or other acute abnormalities.

The  inpatient care was not medically necessary. This patient presented with concern for bright red blood noted on the toilet paper with wiping. His rectal exam was negative for acute blood, his hemoglobin was 11.6, and he presented without hypotension or tachycardia and remained hemodynamically stable throughout. His history of leukemia is noted but this was a childhood disease and was not thought to be active. Otherwise, a recommendation was made to pursue outpatient colonoscopy. It is unclear why this patient presenting with hemoglobin of 11.6, hemodynamic stability, without evidence of active bleeding, with negative CT scan, and without other high risk features (concern for ischemic colitis, need for ongoing anticoagulation, etc.), could not have been safely cared for at a lower level of care. Inpatient care was not medically necessary.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer#2

Diagnosis: Autoinflammatory syndrome

Treatment: Actemra

The insurer denied coverage for Actemra. The denial is reversed.

This patient was then a male child with autoinflammatory syndrome, characterized by fevers, colitis, rash, poor growth. The patient had tried and failed on methotrexate, anakinra, enbrel, infliximab and colchicine. Due to persistent symptoms despite being on these medications, the patient was treated with Actemra with benefit. The patient's clinical workup was significant for D324Y mutation in the RIPK1 protein, which indicated that this patient's condition was rare and difficult to treat.

According to Tao et al (2020), the "data suggest that human non-cleavable RIPK1 variants promote activation of RIPK1, and lead to an autoinflammatory disease characterized by hypersensitivity to apoptosis and necroptosis and increased inflammatory response in peripheral blood mononuclear cells, as well as a compensatory mechanism to protect against several pro-death stimuli in fibroblasts."      

Though Acetemra is not approved by the FDA for this patient's rare inflammatory disease, this is not surprising considering this patient's rare condition and lack of clinical studies on this condition. However, FDA approval should not be the sole basis of approval for use. As per the Miller et al (2018), the "Orphan Drug Act have stimulated significant drug development for rare diseases. Additionally, approvals of orphan indications have been increasing over time. This increasing effect has not targeted a single area of the rare disease space, rather, gains in approvals have been seen across: therapeutic areas, approval types (both new drugs and secondary indications), and for both biologics and small molecule drugs."     

Based on scientific literature, published in peer-reviewed journals, Actemra is supported as appropriate for this patient. Autoinflammatory syndromes, or periodic fever syndromes, are very rare, and if left untreated, can lead to amyloidosis, which has a high morbidity and mortality risks associated with it. Due to the rarity of these conditions, efficacy for treatments must be obtained from case studies or small reports or studies, since large controlled studies are impossible. Literature supports the use of biologics, particularly interleukin-1 inhibitors, such as anakinra. However, for patient's who do not respond to interleukin-1 inhibitors, numerous case studies support the benefit of Actemra.

Considering that this patient has treated with Actemra for over one year with disease in remission, literature supports that this requested medication, Actemra is likely to be more beneficial than any of the standard treatments for this patient.

The carrier's denial of Actemra should be reversed.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer#1

Diagnosis: Autoinflammatory syndrome

Treatment: Actemra

The insurer denied coverage for Actemra. The denial is reversed.

This patient was then a male child with a history of autoinflammatory syndrome. The patient's clinical workup was significant for D324Y mutation in the RIPK1 protein, which indicated that this patient's condition was rare and difficult to treat. The patient's treatment failed on colchicine, methotrexate, Anakinra, Enbrel, and Remicade. With each of these failed medications, the patient continued to have inflammation, pain and fevers. Records show that the patient's symptoms were only responsive to Actemra (tocilizumab) treatment.
As to date, the scientific evidence in peer-reviewed literature is very limited, as this patient's disease is rare disease. However, as per Wegner, et al. (2017), "Many pathologies involving RIPK1 and RIPK3 are associated with the acute or chronic inflammation as well as disruption of immune homeostasis. Understanding the signaling pathways linking necroptosis mediators to inflammatory and immune regulatory circuits may help uncover potential treatments for debilitating diseases that often have lengthy, difficult, and sometimes unsuccessful treatment options." In this case, the patient's condition was not responsive to conventional medications. 

As per  La Torre, et al. (2015), the "[t]reatment is aimed at preventing acute disease attacks, improving quality of life, and preventing long-term complications such as systemic reactive amyloidosis." This small case study, involving a son and a father with a tumor necrosis factor receptor-associated periodic syndrome (TRAPS), which is also a rare, genetic disease, showed successful treatment with canakinumab and tocilizumab, respectively. The study highlighted the clinical and laboratory efficacy as well as the good safety profile of tocilizumab during a 42-month follow-up period.

Though the literature on Actemra for this patient's rare disease is limited. Literature review supports that this patient's disease is difficult to treat with conventional medications, which was true in this case. Consistent with limited but available literature, this patient's symptoms to his rare, genetic disease responded well with tocilizumab (Actemra), and the patient's condition was in disease remission under this treatment. A change in providing this medication would most likely cause an exacerbation of his disease. 

Thus, the requested treatment with Actemra is likely to be more beneficial than any of the standard treatments for this patient. The carrier's denial of Actemra should be reversed.
Appeal type: Medical necessity
Decision: Overturned

Substance Abuse.
Substance Abuse: Inpatient.

Diagnosis: Substance abuse.
Treatment: Inpatient Substance Abuse Treatment.
The insurer denied the Inpatient Substance Abuse Treatment.
The health plan's determination is overturned. 

The patient is an adult male who was admitted following medical screening to acute inpatient level services for monitoring and detoxification and withdrawal management of opioid use disorder with use of three bags of heroin daily with intravenous (IV) administration. 

The patient in this case presented with a diagnosis of severe opioid and stimulant use disorders with occasional use of alcohol. He had a history of severe opioid withdrawal in the past. The patient also has severe psychosocial stressors with limited support and functional impairments, as well as co-occurring mental disorders and general medical conditions including complications of IV drug use.
The presenting clinical features and history and risk for withdrawal and other complications of opioid and stimulant use disorders did warrant the admission and continued inpatient level services with medical monitoring in this case scenario. The patient's admission and continued inpatient stay with detoxification, withdrawal management, and other medical services through discharge could not have been effectively provided at a lower level of care in this case scenario.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: Dizziness and diarrhea
Issue under review: Inpatient admission
The insurer denied the inpatient admission.
The denial is overturned, in part. 

This patient is a male with type 1 diabetes complicated by retinopathy, hypertension, heart failure, gastritis, and pancreatitis presented with diarrhea and dizziness. Temp 37.3, heart rate 99, blood pressure 125/77. Left 3rd finger with dark discoloration, swelling, and foul smell. He was still dizzy in the emergency department after 1 liter of normal saline and unable to get up and walk. He was treated with Zosyn and vancomycin for suspicion for cellulitis of his left 3rd finger. 

Yes, the inpatient admission was medically necessary, in part. 

This patient was admitted with dehydration, orthostatic hypotension, and finger cellulitis. Given his ongoing diarrhea and orthostasis despite intravenous hydration, he required inpatient admission. He also had cellulitis of his finger with initial concern for gangrene requiring intravenous antibiotics and assessment by orthopedics and dermatology. 

He was noted to have significant improvement in his diarrhea. He was determined to have resolving cellulitis with the appearance in part be due to trauma. He was afebrile and his blood cultures were negative. The documentation does not support that he required ongoing intravenous antibiotics or if it was determined that he should receive long-term intravenous antibiotics that these could not be administered at a rehabilitation center. His glucose levels were adequately controlled with subcutaneous insulin. He had ongoing orthostatic hypotension, which was a chronic issue in the setting of autonomic neuropathy and was not an indication for ongoing inpatient admission. Therefore, the requested inpatient admission was medically necessary, in part.