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

This is a patient who had a non ST segment elevation myocardial infarction.  He underwent percutaneous coronary intervention (PCI) of the left anterior descending (LAD).  An echocardiogram showed poor left ventricular function with an ejection fraction (EF) of 20%.  The patient also had a history of smoking and was put on optimal medical therapy.  The health plan's determination is upheld.
The patient had a need for an ICD due to his poor LV funtion, but could not receive one for 12 weeks after his myocardial infarction and PCI.  The health plan provided coverage for the Life vest for 18 weeks.  However, the Zoll LifeVest was not medically necessary during the denied dates.  The patient was eligible to receive an ICD 12 weeks after his PCI.  The medical records supplied do not give any reason why his ICD implant was delayed.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alcohol dependence
Treatment: Continued inpatient admission 

The continued inpatient admission was medically necessary for this patient.

The requested benefit of continued inpatient admission could not have been safely or effectively provided at a lower level of care in this case scenario. The patient in this case was using large quantities of alcohol on a daily continuous basis together with cannabis that did warrant inpatient level detoxification and withdrawal management and monitoring. The patient's social environment was not conducive to an effective detoxification, and the patient struggled with withdrawal symptoms initially with continued risk for withdrawal symptoms in the context of a history or frequent blackouts and severe symptoms of withdrawal in the past. The patient displayed limited to fair insight, impaired judgment and poor control of impulses with regard to the substance use disorders together with co-occurring symptoms of anxiety.

Thus, the adult inpatient stay for detoxification treatment of this patient's substance use disorders did necessitate the continued structure of an inpatient level setting with 24-hour monitoring. The patient's history of substance abuse (frequency and quantity) together with the severe psychosocial stressors and functional impairments (disability) and co-occurring psychiatric disorders of depression and anxiety do reflect the seriousness of the substance use disorder, and the co-occurring disorders that served to trigger the patient's substance use. Again, the clinical features and treatment dimensions in this case do warrant and support the need for a safe and effective detoxification with withdrawal management as the patient was at high risk for treatment failure or general medical complications such as seizures if detoxification and withdrawal management were to have been attempted at a lower level of care. Therefore, medical necessity is met in this case, consistent with prevailing standards of professional practice, published practice guidelines, ASAM Criteria, and the scientific literature, referenced below, and consistent with New York State instruction for medical necessity reviews including the appropriate application of NY OASAS LOCADTR 3.0 Criteria.

The requested benefit of continued inpatient admission is clinically appropriate, medically necessary and warranted in this case scenario. The substance abuse detoxification and continued inpatient level treatment through discharge could not have been safely or effectively provided with lower level services, as noted above. Thus, the requested benefit should be covered in keeping with prevailing standards of care pertaining to the substance use disorder services including ASAM Criteria and the application of the NY State OASAS LOCADTR 3.0 Criteria, referenced below.
Appeal type: Medical necessity
Decision: Upheld

This patient presented to the emergency department with a stab wound to the right chest at the anterior axillary line. The patient has a history of asthma and was complaining of chest pain, shortness of breath, and wheezing. Workup included a chest x-ray with no pneumothorax or hemothorax. The patient also underwent a computed tomography (CT) scan of the chest showing subcutaneous air, but no evidence of intrathoracic penetration. The patient was admitted to the surgical service and discharged to home the next day in improved condition. The health plan's determination is upheld.

This is a superficial stab wound to the chest. The patient stabilized after treatment of asthma. There was no evidence of a pneumothorax, hemothorax, or injury to any intrathoracic vessels or structures. The patient quickly improved and was discharged the next day. This is a very appropriate example of a presentation and management that could have occurred at a lower level of care status. The hospital argued that the initially elevated lactate was part of the justification for inpatient stay, but on a repeat level, not long after the first, it had completely normalized. The first value was very likely erroneous. There was no hemodynamic instability or evidence of deeper penetration of this stab wound. The patient could have been managed at a lower level of care status. An inpatient stay was not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

This is a patient with a past medical history of bipolar disorder, obesity, eczema, overactive bladder, emphysema/ chronic obstructive pulmonary disease (COPD), tobacco use, who presented to the emergency room (ER) with 3 days of bleeding from lesions on her buttocks. She noted a rash, which was itchy, starting on her left ankle and leg, then left hand, and then spreading to the lower abdomen, buttocks, and under her breasts. She had no fevers or chills. The lesions on her buttocks were painful.
On initial exam, she was noted to have an erythematous confluent rash with well-defined borders and swelling with desquamation of the left leg, ankle, and dorsum of the left hand. There were satellite lesions and skin breaks in the lower abdomen, below both breasts, and the medial aspect of the gluteal region. The health plan's determination of medical necessity is overturned. The patient presented with diffuse eczema with superimposed cellulitis. The area of involvement was extensive, involving the left ankle, leg, buttocks, lower abdomen, and under her breasts. There was felt to be a component of both eczema and cellulitis, and an initial concern for Fournier's gangrene. However, given that her lab results were generally unremarkable, except for an elevated lactate, she was not thought to have Fournier's gangrene so her antibiotics were narrowed to IV vancomycin.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cystic Fibrosis with a positive sweat test & Cystic Fibrosis mutation H609R
 
Treatment: Kalydeco

The insurer denied the Kalydeco. The denial was upheld

The patient is a child who has been diagnosed with Cystic Fibrosis (CF) with a positive sweat test. He is known to have two copies of a rare Cystic Fibrosis mutation H609R. The child is pancreatic sufficient but is noted to have failure to thrive. He has a chronic cough and sputum production. There have been 6 hospitalizations in the last few years. The clinical history and x-ray data suggest that the child has had deterioration of his lung disease despite treatment with several approved CF therapies including inhaled albuterol, tobramycin, pulmozyme and 3% hypertonic saline, the clinical examination indicates that he has crackles on the left lung field. There is a note indicating that he has had methicillin resistant staphylococcus aureus (MRSA) isolated from his oral culture and has been treated with Bactrim. There is another note indicating that he has also had achromobacter cultured from his oral culture.

The patient has evidence of significant worsening of his lung disease on his current regimen. Unfortunately, there are only 9 patients in the CFTR2 registry (www.cftr2.org) who are known to have his rare CF mutation and the functional impact of this rare mutation on the CF chloride channel is not known.  Kalydeco is not approved for rare mutations in which the functional consequence of the mutation on the chloride channel is not clearly known. There is a report in the literature concerning patients with this mutation from Ecudaor which indicates that patients with this mutation have "classic" CF and may be pancreatic insufficient. 

Vertex, the manufacturer of Kalydeco, and the CF Foundation have developed a research program (RARE) to help address possible treatment for patients with rare mutations which will gather additional information on the chloride channel function of rare mutations. https://www.cff.org/Trials/Finder/details/477/Rare-mutation-cell-collection-RARE 

Kalydeco in this clinical scenario is not consistent with the standard of care. 
 UP TO DATE: Cystic fibrosis: Treatment with CFTR modulators 

"Cystic fibrosis transmembrane conductance regulator (CFTR) modulators are a new class of drugs that act by improving production, intracellular processing, and/or function of the defective CFTR protein. These drugs represent an important advance in management of cystic fibrosis (CF) because they target the production or function of the mutant CFTR protein rather than its downstream consequences [1]. Their indications and efficacy depend upon the CFTR mutation in an individual patient.
The benefits of these drugs have stimulated the search for additional CFTR modulators. A number of candidate drugs are being actively investigated, some of which have already entered clinical trials

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

Diagnosis: Bipolar disorder, schizoaffective disorder, depression
Treatment: Continued inpatient psychiatric hospital admission
The continued inpatient admission was medically necessary.
The patient represented an acutely elevated risk of dangerous behaviors, and there was no less-restrictive treatment environment appropriate.  The acute risk factors of depression and psychosis with the chronic risk factors of potentially dangerous behaviors suggest that the patient would have been at an acute risk of aggressive or self-injurious behaviors (including but not limited to suicide) were he to have been discharged from the inpatient hospital setting.  The patient was discharged from the inpatient psychiatric hospital setting as soon as a less-restrictive treatment setting was appropriate.  
The patient represented an elevated risk of dangerous behaviors including aggressive behaviors, self-injury, and suicide, and there was no less-restrictive treatment environment appropriate.  Therefore the treatment was medically necessary.  While the patient was not endorsing active suicidality or homicidality, the patient remained psychotic and depressed.  The patient had multiple static risk factors for potentially dangerous behaviors, including prior homicidality, suicidality, and diagnosis with a severe mental illness.  Therefore the patient represented a chronic risk of potentially dangerous behaviors.  The fact that patient remained psychotic was acute risk factor for dangerous behaviors.  Furthermore, the fact that there was no less-restrictive environment of care appropriate suggests that ongoing inpatient psychiatric hospitalization was medically necessary and should be covered by the patient's health plan.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Asthma
Treatment: Inpatient admission
The inpatient admission was not medically necessary.
The patient did not meet the criteria for acute inpatient hospital stay for the COPD exacerbation.  According to the documentation provided, the patient was hemodynamically stable, did not have any acute respiratory failure or acute respiratory distress requiring noninvasive ventilation; in addition, the patient's airway was not threatening requiring intubation with mechanical ventilation.  Her mental status was intact.  She was cooperative and communicative and was speaking in full sentences.  Her oxygen saturation on room air at rest was 95-97%.  Respiratory rate was 20 per minute which was within normal limits.  Hemodynamically including blood pressure and pulse were normal; she was not in shock.  The chest x-ray was clear and it did not suggest the presence of severe pneumonia, pneumothorax or pleural effusion.  The cardiac workup was unremarkable for any acute coronary syndrome.  This patient with acute COPD exacerbation should be considered as mild; therefore, the patient was not a candidate for inpatient hospital admission for management.
Appeal type: Medical necessity
Decision: Upheld

This is a patient with a prior medical history of prematurity and asthma. She was admitted to the hospital for community-acquired pneumonia. According to the available medical records, the patient was ill for about 4 days with a cough, wheezing, and fever at home. Initially she was seen in her pediatrician's office and due to her history of asthma was then taken to the Emergency Department (ED) for evaluation. The expert's determination of medical necessity is upheld.
This child did not have a significantly elevated leukocyte count on her initial evaluation; her white blood cell count (WBC) was 9.9. The child had multiple documented physical exams that stated that she was in no acute distress and was hemodynamically stable. She did not have any increase significant increase in respiratory rate suggesting SIRS. The concerns for SIRS as the justification of the admission, are not reflected in the decision-making documented by the treating physicians. There was never any documented hypoxia on physical exam.
Appeal type: Experimental/Investigational
Decision: Upheld

The patient is male with hypertension, diabetes, permanent atrial fibrillation, and dilated cardiomyopathy who had an echocardiogram which showed left ventricular hypertrophy and an ejection fraction of 25-30%. There was moderate aortic stenosis. A Zoll Life Vest was ordered. The issue for review is whether the wearable cardioverter defibrillator is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.The patient has a newly diagnosed nonischemic cardiomyopathy, with an EF less than (<) 35%. There is no evidence from randomized, controlled, multi center trials or society guideline (such as AHA or ACC) supporting use of the LifeVest for the indication of newly diagnosed nonischemic cardiomyopathy.
Appeal type: Experimental/Investigational
Decision: Upheld

The patient is a male with a history of hypertension, mild left main (LM) and moderate left anterior descending (LAD) disease, diabetes, atrial fibrillation for which he is on oral anticoagulation. He was diagnosed with dilated cardiomyopathy and an ejection fraction (EF) of 25% originally that increased to 35-40%. He was ordered a Lifevest due to severe left ventricular (LV) dysfunction. The issue for review is whether a wearable cardioverter defibrillator is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.There is no documentation that confirms the patient is high risk with persistent heart failure, significant ventricular arrythmias, and has ongoing ischemia. The documents state that the patient has various diagnoses and provides an echocardiogram where the EF was found to be 25-30% without the context of the severity of the patient's condition or determinants that may make the patient at the highest risk of sudden cardiac death and therefore benefit from further optimization of medication. The wearable cardioverter defibrillator is not likely to be more beneficial than standard care for the patient.
Appeal type: Experimental/Investigational
Decision: Upheld

The patient is a male who was diagnosed with congestive heart failure and a nonischemic cardiomyopathy. His left ventricular ejection fraction at that time was 25-30%. He was treated with guideline-directed medical therapy and a LifeVest wearable cardioverter defibrillator (WCD) was prescribed. The issue for review is whether the WCD is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The health plan's determination is overturned. The wearable cardioverter defibrillator was prescribed for the primary prevention of sudden cardiac death in this patient with newly diagnosed nonischemic cardiomyopathy. There are no other treatments for this indication; antiarrhythmic drugs have proven ineffective in sudden death prevention in this patient population and current guidelines do not support the use of implantable cardioverter defibrillators within 90 days of diagnosis of nonischemic cardiomyopathy.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #3

The patient was evaluated for obstructive sleep apnea.  The patient had a sleep study which showed an apnea hypopnea index (AHI) of 15.2.  His body mass index (BMI) is less than 32, at 31.85.  He has tried Continuous Positive Airway Pressure (CPAP) without improvement and he removes the mask during sleep and thus it is not beneficial.  He has tried various types of masks without relief.  He has lost weight approximately 120 pounds in the past six years without relief as well.  The treating provider does not feel an oral appliance therapy is a good option as his sleep apnea is severe (AHI 15) and he cannot tolerate it.  The patient only has surgical options for his treatment availability.  The patient underwent sleep endoscopy and physical findings showed the patient did not have concentric collapse of the upper airway.

The scientific evidence in peer-reviewed literature shows improvement in health outcome. The scientific evidence shows the safety and efficacy of the Inspire device.  The device has been given Food and Drug Administration (FDA) approval for use in moderate to severe obstructive sleep apnea.  There are several studies which have shown the efficacy and safety as well.  The FDA trial was a multicenter, prospective, randomized controlled therapy withdrawal study.  The study which was studied in the NEJM showed 68% reduction in OSA severity with the AHI decreasing from 29 to 9.  Long term follow-up continued to show benefit out to 36 months.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #2

This case involves a male patient diagnosed with obstructive sleep apnea.  The documentation detailed the patient has had a trial and failure of over-the-counter breathing strips as well as mouthpieces to treat obstructive sleep apnea.  The patient continued to suffer from decreased energy.  The patient underwent a sleep study confirming the diagnosis of obstructive sleep apnea.  He was placed on continuous positive airway pressure (CPAP). However, he continued to struggle.  There was no improvement in energy or the sleep apnea.  The physician recommended the requested upper airway stimulation device due to intolerance of continuous positive airway pressure.  The physician referenced the prior sleep endoscopy confirming he does not have complete concentric collapse of the upper airway.  The patient's body mass index was noted to be 31.85.  The request was made for coverage for the hypoglossal nerve stimulator.

The documentation also indicates the patient has had a trial and failure of continuous positive airway pressure.  The patient has also undergone the appropriate imaging for which the physician detailed he did not have complete concentric velopharyngeal collapse.  The patient's body mass index (BMI) was noted to be less than 32.  Therefore, given all of the information it appears that the patient is an appropriate candidate to receive the requested hypoglossal nerve stimulation.  The scientific evidence as noted above does support a result of improvement.  As such, the requested nerve stimulation is considered the best available treatment at this time and is likely to be more beneficial when compared to other standard treatments.  

The carrier's denial of coverage for hypoglossal nerve stimulation or Inspire upper airway stimulation system should be reversed.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Obstructive sleep apnea 

Treatment: Hypoglossal nerve stimulation or Inspire upper airway stimulation.

The insurer denied for hypoglossal nerve stimulation or Inspire upper airway stimulation. The denial was reversed all three panelists determined that the requested service, hypoglossal nerve stimulation, or inspire upper airway stimulation system is a likely be more beneficial than any of the standard treatments/procedures for this patient.

Reviewer #1

This case involves a male patient currently diagnosed with obstructive sleep apnea. The patient had an apnea-hypopnea index (AHI) of 15.2.  The patient's body mass index was 31.85 kg/m2.  The records noted that the polysomnogram eliminated the possibility of central sleep apnea or complex sleep apnea.  The patient had failed and was intolerant to continuous positive airway pressure (CPAP), the gold standard of care therapy for patients with obstructive sleep apnea syndrome.  The patient removed the mask during sleep.  The patient had tried various masks without relief.  The mask caused claustrophobia, skin irritation, difficulty breathing, and dry mouth.  The patient tried a dental appliance without relief.  The patient had daytime fatigue and sometimes had difficulty driving due to fatigue.  The patient had anxiety, depression, and diabetes.  The provider indicated that there were limited alternative treatment options for this patient.  After the sleep endoscopy, the provider noted that the patient did not have complete concentric collapse of the upper airway.  The request was made for upper airway stimulation therapy.

Hypoglossal nerve stimulation or inspiratory stimulation has final approval from the appropriate regulatory bodies for this diagnosis.  The patient is a good candidate for hypoglossal nerve stimulation or inspire upper airway stimulation therapy.  Hypoglossal nerve stimulation or inspire upper airway stimulation system is the best available treatment option for this patient at this time, as he has failed other lower levels of care.  The requested service, hypoglossal nerve stimulation, or inspire upper airway stimulation system is a likely be more beneficial than any of the standard treatments/procedures for this patient, due to a failure of all other treatments.

The carrier's denial of coverage for hypoglossal nerve stimulation or Inspire upper airway stimulation system should be reversed.