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

Diagnosis: Cancer. 
Treatment: Cancer Screening. 
The insurer denied: FoundationOne CDx assay. 
The denial is overturn.

The patient is a male with metastatic gastroesophageal (GE) junction poorly differentiated carcinoma with liver metastasis, stage four (IV) disease. Foundation One (next generation sequencing, [NGS]) was performed on the biopsy tissue. Next generation sequencing revealed microsatellite stable (MSS), tumor mutational burden of 5 mutations per megabase (muts/Mb), GATA6 amplification, Kirsten rat sarcoma (KRAS) G12V, MYC amplification, MYC rearrangement, PIK3CA mutation and platelet derived growth factor receptor alpha (PDGFRA) amplification. The subject under review is whether the FoundationOne CDx test is likely to be more beneficial for the patient than standard therapy.

There is sufficient evidence to support use of next generation sequencing (NGS) in management of metastatic cancers including gastro-esophageal (GE) junction cancer. NGS can identify prognostic biomarkers and therapeutic targets such as tumor mutation burden (TNB), micro-satellite instability high (MSI-H), neutophin receptor tyrosine kinase (NTRK) gene fusion, human epidermal growth factor receptor two (Her 2) amplification, MET amplification, ERBB2 mutation. Genomic testing to identify therapeutic targets is recommended by NCCN (version 4.2021) and by European Society for Medical Oncology (ESMO) guidelines for metastatic cancers.
Such testing has potential to provide additional therapeutic options including Food and Drug Administration (FDA) approved therapies for GE junction cancer harboring specific mutations and genomic abnormalities (Herceptin, Pembrolizumab, Entrectinib, and Larotrectinib) and also allows patients to participate in clinical trials for this fatal disease.
This testing is likely to be more beneficial for this patient than standard treatment.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cancer. 
Treatment: Cancer Screening. 
The insurer denied: FoundationOne CDx assay. 
The denial is upheld.

The patient is a male who was diagnosed with metastatic gastroesophageal (GE) junction cancer. He was found to have liver metastases which were biopsy proven. The tumor was human epidermal growth factor receptor 2 (HER2) negative and microsatellite stable.
The FoundationOne assay was ordered. The subject under review is whether the test is considered to be more beneficial for this patient than any standard treatment.

The proposed health service or treatment FoundationOne CDX is not likely to be more beneficial than any standard treatment or treatments for the patient's life threatening or disabling condition or disease. The National Comprehensive Cancer Network (NCCN) guidelines recommend molecular testing in the selection of systemic therapy options in advanced cases of GE junction cancers. The following markers are recommended: HER2, microsatellite stability, neurotrophin receptor tyrosine kinase (NTRK), Tumor mutational burden and programmed death ligand one (PD-L1). Additional markers are not recommended due to no survival benefit as seen in randomized, controlled clinical trials. The FoundationOne CDX assay is not the standard of care in this case.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cancer. 
Treatment: Cancer Screening. 
The insurer denied: FoundationOne CDx assay. 
The denial is upheld.

The patient is a male with poorly differentiated carcinoma of the esophago-gastric junction with metastatic disease to the liver. At diagnosis, the FoundationOne CDx assay was obtained; this is under review.

The health plan's determination is upheld.

No. The use of next generation sequencing gene panels to guide the treatment of patients with metastatic esophageal cancer has not been demonstrated to be of benefit. The assay in question is Food and Drug Administration (FDA) approved. Several ongoing trials (e.g., the National Cancer Institute [NCI] Molecular Analysis for Therapy Choice [MATCH] and the American Society of Clinical Oncology [ASCO] Targeted Agent and Profiling Utilization Registry [TAPUR] trails) are using next-generation sequencing of multiple genes (gene panel tests) to identify molecular abnormalities in the tumors of patients with refractory cancers that may potentially match molecularly targeted therapies that are either in clinical trials or approved for treatment of other cancer types (National Clinical Trial [NCT] 02465060 and NCT02693535).
Another important point is that simply having a potentially targetable mutation does not guarantee that the patient will benefit from a therapy that presumably targets that mutation. Another potential issue is if targeted testing identifies a potentially actionable genetic abnormality for which a molecularly targeted treatment is available but not yet approved.
Based on the paucity of supporting data, neither the National Comprehensive Cancer Network (NCCN) nor the authors of UpToDate recommend the use of the Foundation Medicine NGS(Next-Generation Sequencing) assay in this clinical scenario. Treatment based on published literature and guideline recommendations has been encouraged.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Left lower leg/ankle injury.
Treatment: Inpatient hospital admission.
The insurer denied coverage for the inpatient hospital admission.
The denial is upheld. 

This patient has a history of chronic substance abuse and alcohol disorder. The patient presented to the emergency department (ED) via ambulance with complaints of pain in her left ankle after she was hit by a car while riding an electric scooter. On exam she had tenderness and a laceration to her left lower leg. The wound was repaired in the ED, and she was admitted to Trauma Surgery for further management. Orthopedics and Addiction Services were consulted. The patient was discharged home and instructed to follow up with her physician. 

Based upon the information provided, the inpatient hospital stay was not medically necessary as the patient could have been treated on an observation status without an acute inpatient admission as this procedure - laceration repair of the left leg did not require an inpatient admission. Furthermore, she did not have a loss of consciousness from her fall. She did not have any focal findings and the x-rays did not reveal any acute process. Pain management could have been done in an observation setting. 

The patient did not meet criteria based upon Milliman Care Guidelines (MCG) as noted by the insurer as there were no associated risk factors that would have necessitated inpatient surgery. Care could have been given in an observation status. Based upon these findings the health care plan did act reasonably and with sound medical judgment. 

Based on the above, the medical necessity for the inpatient hospital admission is not substantiated. The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Seizure-Like Activity after a fall

Treatment: Inpatient hospital admission 

The insurer denied coverage for inpatient hospital admission

The denial is upheld

This case involves an infant who was brought to the emergency department after a fall.  
The caretaker reported that the patient was playing, running around at home when she fell from standing, hitting her head on the wooden floor. The patient's mother picked up the patient, and while in her arms, the patient started having seizure-like activity and apnea lasting 30 seconds. The mother took the baby to the physician's office and called emergency medical services.  The documentation indicated the patient was pale and cyanotic.  The physician was able to arouse the baby by stimulating her.  By the time emergency medical services arrived the patient was at baseline with normal oxygen saturation.  The documentation indicated she had a Glasgow Coma Scale of 15.  She was awake and alert and cried on examination.  She had a blood pressure of 107/59 with respiration rate at 28.  The documentation detailed she was afebrile.  It was recommended she undergo laboratory studies in addition to diagnostic studies.  The physician indicated the patient should be admitted to pediatric intensive care for observation status post fall on wooden floor associated with loss of consciousness and abnormal movement.  Diagnostic image testing did not reveal any findings.  She continued with treatment and the following day was assessed with no new adverse events noted.  Given there were no further deficits, she was discharged with instruction to follow-up.

According to literature a pediatric patient may be admitted when there is evidence of hemodynamic instability, a brain disorder requiring monitoring or intervention only available at an inpatient level of care, evidence of recurrent seizure, evidence that the outpatient antiepileptic regimen cannot be established or when there is evidence of cerebral bleeding or increased intracranial pressure or cerebral edema monitoring.  The documentation submitted does not detail the above.  The documentation indicated the patient was brought in by her caretaker after a fall and a seizure.  The documentation does not detail why the patient could not have been monitored at a lower level such as observation.  Therefore, the health plan acted reasonably with sound medical judgment in the best interest of the patient.

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

Diagnosis: Sepsis 

Treatment: Inpatient admission

The insurer denied coverage for the inpatient hospital admission 

The denial is overturned.

This patient with metastatic breast cancer was sent from the clinical office to the emergency room with hypotension and tachycardia. The patient was status post lumpectomy and reconstruction, chemotherapy, and medication-related cardiomyopathy. She was noted to have sepsis from her underlying breast cancer chest wound. She was placed on intravenous (IV) antibiotics and admitted to the hospital. The patient was discharged on her third inpatient day.

For an individual with cancer on chemotherapy presenting with an infection from the cancer with hypotension and tachycardia, acute level care would be necessary. This patient was noted to have sepsis from her underlying breast cancer chest wound. She presented with hypotension and tachycardia. This inpatient admission is supported by MCG (Milliman Care Guidelines). Therefore, the request for inpatient hospital admission is medically necessary for this patient.

Czajka, M.L., and Pfeifer, C. (2021), "Generally speaking, surgery for breast cancer is a low-risk procedure.  However, a multitude of complications can occur for both lumpectomy and/or mastectomy. In a lumpectomy, positive margins requiring re-excision or mastectomy may occur. Additionally, both procedures may lead to a seroma, hematoma, infection, or skin necrosis.  Injury to surrounding blood vessels, including the axillary vein, may occur. Nerve injury or transection may also occur, leading to sensory or motor defects. An additional complication includes lymphedema, which may occur particularly in the setting of complete axillary node dissection."

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.  The inpatient hospital admission was medically necessary for this patient. 

The insurer's denial of coverage for the inpatient hospital admission is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Status post motorcycle accident.
Treatment: Inpatient admission.
The insurer denied the inpatient admission.
The denial is upheld.

The patient is a male who was involved in a motorcycle accident. He was the helmeted operator of a motorcycle that went to the ground. There was no loss of consciousness. The patient was taken to the emergency department by ambulance. 

In the emergency department, the patient was complaining of back pain. Computed tomography (CT) scans of the head and cervical spine showed no trauma. A computed tomography scan of the chest showed compression fractures of the T4 (fourth thoracic vertebra), T5 (fifth thoracic vertebra) and T6 (sixth thoracic vertebra) vertebrae. There was no neurological deficit. 

Following the patient's emergency department evaluation, the patient was transferred by ground ambulance to another facility for neurosurgical evaluation. The patient had normal vital signs and normal mental status at the time of his transfer. 

At the new facility, the patient was seen in consultation by the neurosurgical service and the trauma service. It was determined that his fractures would be managed without surgery. The patient was admitted under inpatient status. The admission note for this patient indicates that he would be fitted for a back brace. He would have neurological checks performed every 12 hours. He would be seen by a Physical Therapist and an Occupational Therapist. The patient was written for oral medication and an oral diet. The following day, the patient's pain was controlled with oral medication. He was able to ambulate with a back brace. The patient was discharged home.

No, the proposed treatment was not medically necessary.
At the time this patient was kept in the hospital, he was clinically stable. He had undergone a comprehensive trauma evaluation. He was found to have compression fractures of three vertebrae in his thoracic spine. There was no associated neurological deficit. The admission note for this patient indicates that his plan of care would not include surgery. Neurological checks would be done every 12 hours. Pain medicine would be given. The patient would be fitted for back brace. An evaluation by a Physical Therapist and Occupational Therapist was anticipated. The patient was written for oral medication and an oral diet.

At the time this patient was kept in the hospital, he had no intensity of required services to justify an inpatient admission. No surgery was planned for him. No additional testing was planned for him. It would have been reasonable to believe that this limited plan of care could be accomplished with a short stay in the hospital. For this reason, an inpatient admission was not medically necessary.

Yes, the health plan did act reasonably in denying coverage for an inpatient admission.
An inpatient admission was not medically necessary. The patient was clinically stable. A limited plan of care was anticipated for him. The patient did not require acute inpatient level of care.
Appeal type: Medical necessity
Decision: Overturned

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

The patient is a boy who presented with lethargy.
He was well until a week prior to presentation when he developed fever. He was receiving acetaminophen and ibuprofen at home, but his fevers continued and were up to 103 F (Fahrenheit). He was seen by his primary doctor and was diagnosed with otitis media and prescribed amoxicillin. He had been receiving amoxicillin as directed, but he continued to be ill and developed decreased activity and decreased interactions with others. He wasn't getting up or walking around, and he also had decreased oral intake. His fevers had resolved, and he had no upper respiratory symptoms. Due to the persistence of his symptoms, he was brought to the emergency department for care.

The inpatient hospital admission was medically necessary for this patient.
Children who are suspected of having bacterial meningitis or other serious bacterial infections should be admitted to the hospital for intensive management and monitoring. This is a young boy with a history of fever who presented with lethargy. He was hypothermic and had delayed capillary refill at the time of presentation. He required a prompt work up and initiation of treatment for potentially severe infection including concern for partially treated meningitis. This requires inpatient care due to the potential spread of infection and clinical deterioration.
The decision making at the time of admission for this patient was consistent with his young age, the presence of lethargy and concern for serious bacterial infection, and the need for prompt evaluation and initiation of therapy along with close monitoring for potential deterioration of clinical status.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic Migraine Headaches. 
Treatment: Botox (J0585). 

The insurer denied the Botox (J0585). 
The denial is upheld. 

The member is a female with chronic migraine headache disorder. She is treated with Botox and Aimovig. The provider is requesting continuation of Botox. This was denied coverage as the Plan does to cover Botox if it is used concurrently with a CGRP (Calcitonin Gene-Related Peptide) inhibitor for migraine prevention. 

No. The requested Botox is not medically necessary. 

There are no high quality clinical studies or standard of care guidelines demonstrating that Botox is safe or effective when used with Aimovig for migraine prevention. The pivotal trial leading to the FDA (Food Drug Administration) approval of Aimovig for migraine prevention (Goadsby et al.) excluded persons who were treated with Botox at study commencement. The extent of the medical literature includes one retrospective chart review (Blumenfeld et al.). This does not breach the threshold of evidence required to conclude that dual therapy is effective. There are no high quality, randomized, prospective, controlled trials demonstrating that dual therapy with Botox and a CGRP (Calcitonin Gene-Related Peptide) inhibitor is more effective than using either agent alone for prevention of migraine. Recent review (Pellesi et al.) concluded that "there is currently only indirect preclinical evidence to support a rationale for dual therapy with anti-calcitonin gene-related peptide monoclonal antibodies and botulinum toxin type A for chronic migraine prevention" and that "Rigorous studies evaluating clinical efficacy, safety, and effectiveness are needed."  Therefore, the safety and efficacy of Botox combined with Aimovig remains undetermined. 

Yes. The health plan did act reasonably, with sound medical judgment and in the best interest of the patient.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal. 
Treatment: Surgical Services (All). 

The insurer denied Intracept Procedure. 
The denial was upheld.

The patient is a male with a past medical history of axial low back pain, absent extremity pain, aggravated by lumbar extension and rotation. Medical records report the patient failed "conservative therapy." The magnetic resonance imaging (MRI) scan reports multilevel disc degeneration with "degenerative end plate changes" and facet arthropathy at lumbar (L)5-sacral (S)1. The patient has had lumbar facet medical branch radiofrequency neurotomy on at least two occasions with reported greater than (>) 85% - 90% relief of low back pain. 
At issue is whether the Intracept procedure is likely to be more beneficial than any standard treatment for the patient's condition.

The health plan's determination regarding the proposed health service or treatment is upheld in whole.

The proposed health service or treatment Intracept Procedure is not likely to be more beneficial.
While there is adequate evidence of the efficacy of Intracept Procedure in the setting of Modic I and/or Modic II type endplate changes with vertebrogenic axial low back pain, there is no evidence for the efficacy of the procedure in the setting of facet mediated pain. The medical records detail a patient with evidence of facet mediated pain. Specifically, pain aggravated by lumbar extension and rotation and pain relieved (85-90%) on more than one occasion following lumbar medial branch radiofrequency ablation including the L5-S1 level.
Therefore, the proposed health service or treatment Intracept Procedure is not likely to be more beneficial than any standard treatment for the patient's condition.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal. 
Treatment: Surgical Services (All). 

The insurer denied Intracept Procedure. 
The denial was upheld.

The patient is a male with complaints of long-standing low back, neck, and right knee pain. He is noted to have chronic low back pain. The patient has undergone multiple lumbar injections, including radiofrequency ablation treatments. His medications include nonsteroidal anti-inflammatory drug (NSAID)s as well as opioids. His prior treatment has consisted of physical therapy. The physical exam documented positive cervical facet loading bilaterally, positive Kemps test bilaterally, and right knee tenderness.
A magnetic resonance imaging (MRI) scan of the lumbar spine reported convexity of the lumbar spine towards the left, multiple disc herniations, and multilevel degenerative changes. The patient's diagnoses include Spondylosis without (w/o) myelopathy or radiculopathy, lumbar region. There is a recommendation for the Intracept Procedure by his provider.
At issue is whether the proposed health service or treatment Intracept Procedure is likely to be more beneficial than any standard treatment or treatments for the patient's condition.

The health plan's determination regarding the proposed health service or treatment is upheld in whole.

The proposed health service or treatment Intracept Procedure is not 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 complaints of low back pain. There is a request for Intracept Procedure or intraosseous basivertebral nerve ablation. Despite promising early reports, further trials with longer-term outcomes and less risk of bias are required. A United States Food and Drug Administration (FDA) investigational device exemption trial examined 225 chronic low back pain patients with type I or II Modic changes who were randomized to the requested procedure or sham treatment, resulting in decreased Oswestry disability index (ODI) of 20.5 and 15.2 points, respectively. The authors noted that these marginally clinically meaningful improvements suggested some potential as a minimally invasive treatment, however, there is a lack of data to recommend this procedure as a treatment modality. In general, there is a lack of substantial support for this procedure, and it is currently not considered standard of care.
Given this, the proposed health service or treatment Intracept Procedure is not likely to be more beneficial than any standard treatment or treatments for the patient.