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

Diagnosis: Cancer / Lung cancer
Treatment: Lab work/Blood tests 
The insurer denied Genetic Testing of Tumor DNA 
The denial is upheld

The patient who underwent a right upper lobe lung mass biopsy.  The biopsy revealed moderately differentiated adenocarcinoma. Molecular profile on the tissue was ordered. PD-L1 was positive. KRAS was not performed due to inadequate tissue.
No, the proposed health service, Genetic Testing of Tumor DNA, is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition.
The National Comprehensive Cancer Network (NCCN) Guidelines recommend tissue based molecular analysis for advanced stage non-small cell lung cancer in choosing systemic therapies.
The following markers are as follows: EGFR, ROS1, MET, BRAF, KRAS, PD-L1, ALK, NTRK, HER2 neu and Tumor mutational burden.
Plasma cell-free/circulating tumor DNA should not be used in lieu of a histologic tissue diagnosis. Such assays have compromised sensitivity and up to 30% false negative rates. Standards for analytic performance have not been established and no guideline exist regarding the recommended performance characteristics of these types of tests. Cell-free tumor DNA testing can identify alterations that are unrelated to a lesion of interest.
The use of these type of assay can be used if a patient is medically unfit for invasive tissue sampling and if there is insufficient material for molecular analysis.
This patient had invasive tissue sampling. There was documentation of KRAS not being able to be performed due to lack of tissue but no comment on the other markers being available for testing. The pathology report mentioned not enough tissue for anaplastic lymphoma kinase (ALK). There is no information to the effect of not enough tissue for epidermal growth factor receptor (EGFR). 
Therefore, the assay in this case is considered investigational/experimental.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Cancer / Lung cancer
Treatment: Lab work/Blood tests 
The insurer denied Genetic Testing of Tumor DNA 
The denial is overturned in whole 

This case involves a request for a circulating tumor deoxyribonucleic acid (DNA) assay (Guardant 360) for patient with metastatic non-small cell lung cancer where there was insufficient tissue available to perform gene sequencing to allow for optimal treatment 
Yes, the proposed health service is likely to be more beneficial than standard treatment for the patient's condition. 
Circulating tumor DNA assays have been used extensively in solid malignancies to detect actionable driver mutations, to monitor treatment response, to detect recurrence, to identify resistance mechanisms, and to prognosticate outcome. This is the case here as the patient's initial tissue specimen was deemed inadequate for full molecular testing.
Such circulating tumor DNA analysis has become a mainstay in the management of non-small cell lung cancer in such situations and is endorsed by the national cancer care network (NCCN) guidelines.
This is a case where insufficient material was available from a biopsy to provide the information necessary for the patient's oncologist to optimize management and is the ideal scenario where such a test should be used.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Cancer / Lung cancer
Treatment: Lab work/Blood tests 
The insurer denied Genetic Testing of Tumor DNA 
The denial is overturned in whole 

This is a patient with metastatic adenocarcinoma of the right lung, with mediastinal adenopathy. The patient  has a past medical history of anxiety, Lyme's disease, laminectomy, emphysema, arthritis, and irritable bowel syndrome. There is insufficient tissue for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) testing.
Yes, this laboratory study, Genetic testing of Tumor DNA is likely to be more beneficial than standard treatment for the insured's condition.
The use of next generation sequencing gene panels to guide the treatment of patients with metastatic lung cancer is recommended by the National Comprehensive Cancer Network (NCCN) Guidelines, which state "...t is recommended at this time that when feasible, testing be performed via a broad, panel-based approach, most typically performed by next generation sequencing (NGS).... The assay in question is FDA approved. It is noted that there is insufficient tissue available for the recommended biomarker testing, which includes EGFR and ALK. Such testing is recommended by the NCCN, by the peer-reviewed literature, and by the authors of UpToDate and the availability of a liquid biopsy overcomes the limitations of testing on tissue obtained from a biopsy.
The authors of UpToDate state "...GS overcomes many of the shortcomings of direct sequencing and allele-specific testing...It retains sensitivity even in specimens with low tumor cellularity, which is an improvement over direct sequencing, and can identify new abnormalities, which would not be detected by allele-specific testing. Moreover, NGS can often detect abnormalities that would historically be tested by FISH...". These include the tumor mutation burden (TMB); the use of which is utilized to aid in identifying patients who might be candidates for immunotherapy, as well. The assay in question is Food and Drug Administration (FDA) approved for this indication and is not the subject of ongoing investigation for these purposes.
For these reasons, the use of this assay in this scenario meets criteria for medical necessity and is not experimental investigational.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Obesity
Treatment: Qsymia
Decision:  Overturned

Summary:
This is a female diagnosed with Obesity. This request is for Qsymia. As reported; her BMI (body mass index) was 27. She was on both Saxenda and Belviq. Belviq has been pulled off the market and she remained on just Saxenda. Since she stopped Belviq she has gained weight. She also has type 2 diabetes mellitus and hyperlipidemia both of which are comorbidities with her weight. On 04/02/2020 her height was 172.72 cm; weight was 80.739 kg; BMI was 27.06.

Qsymia is indicated in the treatment of obesity [1-3]. The FDA label [4] is as follows:

--------------------INDICATIONS AND USAGE------------------------- 
Qsymia is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate extended-release, an antiepileptic drug, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m2 or greater (obese) (1) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia (1) Limitations of Use: The effect of Qsymia on cardiovascular morbidity and mortality has not been established (1). The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over the-counter drugs, and herbal preparations, have not been established (1).

The patient has a BMI greater than 27. The patient has type II diabetes, which is a weight -related comorbidity. The patient meets the FDA indication and the standard of care. The requested service is consistent with generally accepted standards of medical practice. The health plan should cover the proposed treatment.
Appeal type: Medical necessity
Decision: Overturned

Cancer
Nursing Services (including Private Duty Nursing)

Diagnosis: Colon Cancer
Treatment: Personal Care Aide (PCA) Level 2 Services. The health plan denied the PCA services. The health plan's determination is overturned. 

The patient is a female with multiple medical problems including colon cancer, osteoarthritis, status post ileostomy, hypertension and recent decubitus ulcer. This review is for the medical necessity of Increase in Personal Care Aide (PCA) Level 2 Services: Live-in per diem - 24 hours per day - a total of 7 days per week.

The requested increase in personal care aide (PCA) level 2 services: live-in per diem - 24 hours per day - a total of 7 days per week is medically necessary for this patient. The patient is an elderly female with multiple medical problems most notably colon cancer and cerebrovascular accident (CVA) with hemiparesis, along with generalized deconditioning and gait abnormalities. She requires help in all activities of daily living (ADL) and extensive assistance in most all instrumental activities of daily living (IADL). She is non-ambulatory. She has urinary incontinence. Prior to hospitalization and recumbency in skilled facility, the patient was receiving 24-hour care. Recently in a nursing home, she had evidence of sacral decubitus ulcers. Fortunately, they have improved prior to discharge home.

Based upon reviewing the submitted documentation, it is clear that the patient has multiple medical problems including need for extensive assistance with almost all ADLs. She has evidence of urinary incontinence along with recent sacral decubitus ulcer requiring treatments. Therefore, the requested increase in personal care aide (PCA) level 2 services: live-in per diem - 24 hours per day - a total of 7 days per week medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest pain
Treatment: Inpatient Hospital Stay. 
The insurer denied the Inpatient Hospital Stay. 
The denial was upheld.


This patient presented to the emergency department complaining of intermittent, pleuritic, nonexertional chest pain. Her physical exam was unremarkable. Her electrocardiogram showed sinus rhythm with no ischemic changes. Her troponin level was normal. A chest X-ray showed no acute pathology. A cardiology consultation was obtained; the cardiologist opined that the patient's symptoms were highly atypical for ischemic pain. The consultant recommended an echocardiogram. The note indicated that the patient was stable for discharge and could be discharged after her echocardiogram that was scheduled for the next morning. The echocardiogram was unremarkable and the patient was discharged. The medical necessity of an inpatient admission is under review.

An inpatient level of care was not medically necessary. This patient, with known coronary artery disease, presented with atypical chest pain. Her electrocardiogram showed no ischemic changes and her cardiac biomarkers were normal. Her HEART score of 3 indicated a low risk for major adverse cardiac events. She did not require intensive monitoring or infusion of intravenous cardioactive medications. The care this patient received did not require an inpatient admission and could have been provided at a lower level of care. This approach has been shown to be safe and is in accordance with the 2014 American Heart Association (AHA) / American College of Cardiology (ACC) Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes.
Appeal type: Medical necessity
Decision: Overturned in Part

Mental Health
Mental Health: Inpatient

Diagnosis: bipolar disorder
Treatment: Inpatient mental health. The insurer denied the inpatient mental health stay. The health plan's determination is overturned in part. 15 days are medically necessary. 

The patient is a male with diagnoses of bipolar disorder (BPD) with psychotic features versus (vs.) schizoaffective (SCZD) disorder admitted to Behavioral Health Inpatient Treatment (BHIT).

The requested treatment of BHIT for 15 days is medically necessary. Discharge before this would be against this patient's best interests in view of his multiple psychosocial stressors, past history, and comorbid conditions. Poor social attachment is associated with increased suicide risk. This patient has multiple stressors which interact with his genetic predisposition to increase his suicide risk. This patient had a clear genetic predisposition in addition to multiple psychosocial stressors. The only acceptable goal for treatment of bipolar disorder is sustained euthymia, without psychotic features. Considering all his risk factors, it is medically necessary and reasonable to require several days of sustained improvement to avoid discharge premtaurely for this patient. The evidence from case notes supports sustained improvement, leading to the judgment that it would be in the best interest of the patient and in accord with current standards of best care that the patient be discharged on day 15. Discharge prior would have a high probability of relapse and the need for rehospitalization.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Possible acute gastritis

Treatment: Inpatient admission 

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

The patient is a male with a past medical history of coronary artery disease, ischemic cardiomyopathy with an ejection fraction of 21%, paroxysmal atrial fibrillation, hypertension, hyperlipidemia and on Eliquis who presented to the Emergency Department (ED) with complaints of chest pain for 2 to 3 days prior to presentation. The patient then had recently had an automated implantable cardioverter/defibrillator (AICD) shock and he was started on Amiodarone.  At the ED, the patient's pain was noted to be in the epigastric and the right chest region.  The patient was admitted and was monitored on telemetry. The patient's condition was ruled out for myocardial infarction. The patient's troponin levels were negative.  The patient's chest x-ray did not indicate any acute cardiopulmonary disease.  The patient was evaluated by Cardiology.  It was determined that the patient's chest pain was non-cardiac in nature, and possibly related to acute gastritis.  The patient was advised to start Protonix.  The patient was deemed stable for discharge with outpatient instructions to follow-up with his Cardiologist.

Based on the review of the medical record, the patient presented with chest pain.  The patient's initial evaluation in the Emergency Room (ER) was unremarkable, including non-diagnostic electrocardiogram (EKG) and cardiac biomarkers.  Inpatient admission was not medically necessary for this patient.  The patient's care could have been provided in the observational setting, allowing for additional diagnostic testing.  Literature supports that further evaluation was warranted, however inpatient admission criteria was not met.  There was no hemodynamic instability, cerebrovascular insufficiency, hypoxemia requiring supplemental oxygen or support, myocardial ischemia, or other medical conditions warranting acute inpatient level of care. 

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

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

Diagnosis: Tooth pain, Tooth decay/caries

Treatment: D2751: white glass with metal crown, Tooth #11 and D3310: nerve treatment on front tooth, Tooth #11

The insurer denied coverage for D2751: white glass with metal crown, Tooth #11 and D3310: nerve treatment on front tooth, Tooth #11. The denial is upheld

This patient is a female who presented with pain affecting tooth #11. Based on the clinical and radiographic findings, endodontic therapy, and full coverage crown restoration for tooth #11 was recommended. The insurer has denied the services stating that these services are not medically necessary treatment as there is significant bone loss which would impart a poor long term prognosis for this tooth. The patient is appealing the denial.

Based on the submitted information for review, particularly the radiographic images examination #11, there is significant decay /caries markedly undermining and compromising tooth integrity and tooth structure and involving the root structure.  This decay clinically is subgingival and radiographically extends below the alveolar bone height. There is also significant alveolar bone loss and loss of periodontal support of this tooth. Effectively this tooth will remain a retained root tip.  The extent of caries renders this tooth a poor support for full coverage restoration.  Additional definitive treatment after caries removal in the attempt to maintain this tooth in the arch would require periodontal crown lengthening surgery as there is inadequate biologic width, further compromising crown and root ratios, leaving less tooth structure than currently exists as support of a fixed crown.  As this tooth would be prosthetically poor support for a crown restoration, it is determined that the services as recommended are not medically necessary.

Uphold denial for coverage for D2751: white glass with metal crown, tooth #11 and D3310: nerve treatment  on front tooth #11 as not medically necessary as this tooth exhibits significant caries and periodontal bone Joss and therefore has a poor long-term prognosis and would be unsuited prosthetically for support of a full coverage crown.

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

Based on the above, the medical necessity for D2751: white glass with metal crown, Tooth #11 and D3310: nerve treatment on front tooth, Tooth #11 is not substantiated.  The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Overturned

Respiratory System
Inpatient hospital

Diagnosis: Pneumonia
Treatment: Inpatient stay
The insurer denied the inpatient stay. The health plan's determination is overturned.

The patient is a boy with Down syndrome who presented to the emergency department with chest pain and cough. He was admitted to the hospital for bilateral lower lobe pneumonia and reactive airways disease, for continued treatment and close monitoring. He was treated with parenteral ceftriaxone as well as azithromycin and albuterol as needed. He was also continued on intravenous fluids. During the admission, he continued to have pain in the lower left side of his chest as well as some wheezing.

This is a young boy with Down syndrome who presented with a persistent cough and chest pain, and x-ray findings consistent with bilateral lower lobe pneumonia. He required parenteral treatment with antibiotics as well as intravenous fluids and close monitoring. Indications for hospital admission for children with pneumonia include underlying conditions that may predispose to a more serious course, including genetic syndromes (such as Down Syndrome). His underlying medical condition of Down syndrome places him at high risk for complications of lung disease as well as greater risk of infection. In fact, during his admission he developed increased wheezing and required additional treatments with Atrovent and prednisone.
The decision-making at the time of admission for this patient was consistent with his young age, his diagnosis of Down syndrome, the presence of bilateral lung disease, and the need for prompt initiation of treatments with close monitoring for potential deterioration of clinical status.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental Disorder.
Treatment: Braces.
The insurer denied Braces.
The determination is overturned.

The patient has a Class 1 malocclusion with protrusive maxillary incisors. The lower arch is severely crowded with tooth number (#) 26 completely blocked out to the lingual. She is treatment planned for 24-30 months of orthodontics with extraction of 5, 12, 21, and 28 to correct the crowding and protrusion. Her health plan denied the braces on the basis that treatment is not medically necessary. At issue is the medical necessity of braces.
The braces are medically necessary. Teeth #8 and #9 are protruding forward within the dental arch. This makes them more prone to trauma. There is strong medical evidence that early correction of patients with prominent maxillary front teeth can reduce the risk of incisor trauma.(1) Extraction of four premolars combined with orthodontics will make her teeth less protrusive. Evidence shows orthodontic treatment will reduce the chances of damage to the maxillary incisors and the associated morbidity of repairing these teeth. For this reason, the treatment is medically necessary.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Major depressive disorder

Treatment: Replacement of vagus nerve stimulator

The insurer denied coverage for replacement of a vagus nerve stimulator.

The denial is overturned. 

The patient is a female with a history of Major Depressive Disorder (Recurrent, Severe). The patient had a vagus nerve stimulator (VNS) implantation 12 years ago for a treatment resistant depression. Recently her VNS stimulator was no longer providing response and it was determined that she required replacement of the generator and possible revision of the leads.

VNS Therapy is an FDA approved treatment for chronic depression in patients who have failed to respond to at least 4 antidepressant treatments (date of FDA approval is 7/15/05). The treatment has shown utility in experimental trials published in peer reviewed journals (Biological Psychiatry 2005;58:347; Biological Psychiatry 2005;58:364; Biological Psychiatry 2005; 58:355; and Journal of Clinical Psychiatry 2005; 66:1097) indicating the treatment's usefulness and effectiveness. There is also at least one study showing no benefit when compared to sham stimulation (Biological Psychiatry 2005; 58:347). There are additional studies showing that the response to VNS therapy may accrue over time; one five year observational study showed the VNS therapy provided enhanced antidepressant effects compared with treatment as usual (AmJPsych 2017; 174:670).

Based upon the information presented, the patient's condition meets the criteria for continued treatment with VNS therapy. She has had trials with multiple antidepressant and psychoactive medications, psychotherapy and electroconvulsive therapy (ECT) with failure to improve. She suffers with refractory depressive symptoms. She has responded to VNS therapy in the past and now requires surgical replacement of the stimulator and leads. The VNS therapy being recommended is FDA approved for the treatment if refractory depression and has been shown to be mildly to moderately effective in peer reviewed literature; based on her failure to respond to multiple previous treatments and her past response to VNS therapy she medically requires such stimulator replacement therapy. 

The decision relies upon the scientific literature cited above, and the patient is an excellent candidate based upon her history of response to VNS for this replacement treatment. Replacement of the stimulator and leads is the most effective treatment for the patient based upon her history, and it is therefore more beneficial to her than other treatments for depression.
 
The carrier's denial of replacement implantation of vagus nerve stimulator should be overturned.