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

Diagnosis: Pancreatic cancer

Treatment: Guardant 360 liquid biopsy 

The insurer denied coverage for Guardant 360 liquid biopsy.

The denial is upheld.

This patient has metastatic pancreatic cancer and previously underwent FoundationOne testing. The treating provider has now performed Guardant 360 testing. The plan denied the service as they consider the testing experimental/investigational.

The use of next-generation sequencing (NGS) panel testing as a means to select anti-cancer therapy in advanced cancer remains an area of active research with ongoing studies. The concept of this approach is that all cancers are unique, and each cancer has a specific individual molecular driver which can be identified using this testing. Once identified, specific therapy can be given to the patient directly treating their tumor. The majority of studies of this approach are fraught with methodological design issues such as lack of randomization and inclusion of large numbers of patients with established molecular drivers and then claiming that the identification and targeting of said known drivers contributes to benefit. There has been only one well designed trial of this approach, SHIVA (molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer) trial, which demonstrated that this testing approach does not improve clinical outcomes for patients with advanced cancer.  

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome with the uses of the Guardant 360 liquid biopsy. The Food and Drug Administration (FDA) has approved the Guardant 360 liquid biopsy testing; however, this patient is not a good candidate. The adverse risks are increased over the standard treatment/services. This will likely lead to attempts to use unapproved agents, with no clinical evidence of benefit, leading to toxicity.

This individual already underwent testing, there was no reason to perform repeated testing. National Comprehensive Cancer Network (NCCN) recommends molecular profiling if not already done. As noted, FoundationOne testing, and results are in the records submitted.

Standard testing for pancreatic cancer includes microsatellite instability (MSI), tumor mutational burden (TMB), and breast cancer 1/2 (BRCA 1/2). While this is included in Guardant360 testing, it was also included in Foundation One testing previously completed. There is no reason to conduct repeated testing in pancreatic cancer, as the requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of Guardant 360 liquid biopsy be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Pancreatic cancer

Treatment: Guardant 360 liquid biopsy 

The insurer denied coverage for Guardant 360 liquid biopsy.

The denial is upheld. 

The patient has a history of metastatic cancer with liver metastases. He presented to the oncologist's office for a third cycle of Folfirinox. Restaging scans were ordered. The patient had Guardant 360 liquid biopsy to further guide the course of treatment. The plan denied coverage of the liquid biopsy.

According to Yadav, et al., "a liquid biopsy can possibly be used to diagnose pancreatic cancer (PC) at an early stage, predict prognosis, monitor PC stage, therapeutic efficacy or resistance, and provide optimal, personalized treatment strategies for patients with PC. This review has endeavored to organize the present advances in liquid biopsy for PC into a solitary idea to establish an effective management plan and implementation of these understandings to bolster energizing zones of research. But the fundamental question remains: Can liquid biopsy become a screening reality for pancreatic cancer?"

Kuderer, N. M., et al. notes "Although these results are preliminary, significant discordance also has been noted between reports comparing tissue-based next-generation sequencing tests and, in a recent report, between results from FoundationOne (F1) and Guardant360 (G360) testing. Our findings indicate that in-depth comparisons of next-generation sequencing tests across larger numbers of patients with cancer are needed to improve concordance and clinical utility." 

The Food and Drug Administration (FDA) has approved this testing. This patient is not a good candidate for Guardant 360 liquid biopsy, and it is not the best available treatment for this patient at this time. There are no appreciable risks to a blood test. There is insufficient cogent medical literature to show that this liquid biopsy modality has a positive effect on healthcare outcomes. As such, standard care with repeat attempts at tissue biopsy for this patient with metastatic pancreatic cancer would be the appropriate option for this member.   

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                 

The carrier's denial of Guardant 360 liquid biopsy should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Pancreatic cancer

Treatment: Guardant 360 liquid biopsy 

The insurer denied coverage for Guardant 360 liquid biopsy.

The denial is overturned.

The patient has pancreatic cancer with liver metastases. He has been receiving cycles of Folfirinox. The cancer antigen 19-9 (CA19-9) levels were dropping. A fine needle aspiration was done of the pancreatic mass. Guardant 360 liquid biopsy was done. 

UpToDate has an article titled "Personalized genomic-directed therapy for advanced non-small cell lung cancer" which discusses the topic of liquid biopsies. The article states that blood-based tests or so-called liquid biopsies are gaining popularity as they provide the opportunity to genotype in a less invasive manner when there is insufficient tumor sequencing. It may offer a chance to monitor the molecular features of a cancer through the course of treatment or predict relapse after adjuvant treatment. The Food and Drug Administration (FDA) has approved these tests to identify mutations. It is likely that the use of liquid biopsies to assess molecular abnormalities will become more widespread.

The UpToDate article titled "Assessment of tumor response in patients receiving systemic and nonsurgical locoregional treatment of hepatocellular cancer" states that liquid biopsies can be analyzed to detect circulating tumor cells and plasma cell-free circulating tumor deoxyribonucleic acid (DNA). A systematic review of 112 studies concluded that changes in the number of circulating tumor cells could more accurately identify patients with a hepatocellular carcinoma (HCC) recurrence after resection or locoregional therapy.

Annals of Translational Medicine has an article titled "Real-time liquid biopsies become a reality in cancer treatment." The article states that liquid biopsies can be used to monitor the effect of cancer treatment, give an early warning about possible recurrence, and offer clues to the reasons for treatment resistance.

The scientific literature supports the use of liquid biopsy testing for improvement of health outcomes. The Guardant 360 liquid biopsy is FDA approved. The patient is a good candidate because he has been receiving chemotherapy for an advanced malignancy and genomic testing was not feasible with the available tissue. There are various ways to monitor the tumor response to therapy but there are no adverse risks in obtaining the liquid biopsy. The patient would benefit from genomic testing and in view of the limited available tissue, the liquid biopsy is a reasonable alternative.

The requested service is likely to be more beneficial without increased risk over standard therapies.

The carrier's denial of Guardant 360 liquid biopsy should be overturned.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Stelara subcutaneous (SQ) 90 milligrams (mg). 
The determination is overturned.

The patient is a female with severe ulcerative colitis and primary sclerosing cholangitis (PSC). She has previously tried and failed two anti-tumor necrosis factor (TNF) agents (infliximab & adalimumab) and an anti-integrin agent vedolizumab in the past. She was started on Stelara at standard dosing but did not achieve remission. Hence the attending provider would like to escalate the dose of Stelara to 90 milligrams (mg) subcutaneously (SC) every 4 weeks to treat this patient's severe ulcerative colitis. The subject under review is the medical necessity for the requested Stelara.

The requested health service/treatment of Stelara SQ 90 mg is medically necessary for this patient. Dose escalation is the standard of care in patients with inflammatory bowel disease (IBD) who are on biological therapy and are not responding to standard dose of their biological medication. Since this patient was not responding to standard dosing of Stelara, it is reasonable to increase the dose of Stelara to 90mg every 28 days (4 weeks). Dose escalation in biologic therapy used in inflammatory bowel disease can be done based on clinical symptoms and signs or therapeutic drug monitoring by either increasing the dose of the dose or shortening the interval infusions or sometimes a combination of both. Based on the clinical data provided and current evidence, the use of Stelara at the escalated dose of 90mg every 4 weeks to treat this patient's severe ulcerative colitis as requested by the attending provider is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cardiac/Circulatory Problems. 
Treatment: Inpatient Hospital. 

The insurer denied inpatient stay. 
The denial is overturned. 

The patient is a female admitted after presenting to the hospital with chest pain and vomiting. The patient complained of racing heart, nausea, vomiting, and diarrhea. The temperature was 97.4  Fahrenheit (F), heart rate 136, and blood pressure 99/86. On exam, the patient was ill-appearing, with mild distress. She was overweight, with S1 and S2 heart sounds, tachycardic, lungs clear to auscultation bilaterally. The abdomen is described as soft and nondistended with no rebound. Chest x-ray was negative for infiltrates, and computed tomography (CT) of the abdomen / pelvis showed no signs of an infection. The patient has a history of multiple blood transfusions secondary to bleeding fibroids. 

Laboratory studies revealed significant leukocytosis of 33,000, with hemoglobin of 11. Lactate was 3.61 initially, with a mild decrease in bicarb at 19.7. The patient was admitted to the hospital with a diagnosis of sepsis of unclear source. The procalcitonin level was elevated at 11. The patient was given aggressive intravenous (IV) fluids, per sepsis protocol. 

The next day, the patient had no complaints. She had no bowel movement, just gas. The exam was fairly unremarkable. Repeat white blood cell count was 11.8, hemoglobin eight, and platelets of 188. The rest of the labs were stable. Blood cultures were negative for growth at 48 hours, vital signs were stable, and repeat labs were similar to the day before, except white blood cell count had completely normalized at 8.7. The infectious disease specialist reassessed the patient and documented a leukemoid reaction with no source of infection. The infectious disease specialist recommended switching antibiotics to oral the next morning. 

The hematologist reassessed the patient and recommended further outpatient workup. The patient was deemed stable and released safely home. All the cultures were negative, 7 days of oral antibiotic course was prescribed by infectious disease. 
The question is whether the above presentation warranted an inpatient level of care. 

The health plan's determination is overturned. 

Based on the provided documentation, it is reasonable for this patient to be admitted under an inpatient level of care. The patient had sepsis with tachycardia, hypotension, elevated lactate level, and elevated procalcitonin. The presentation satisfied severe sepsis criteria of unclear source. Based on medical necessity, it was reasonable to expect this patient to be in the hospital for at least two midnights for ongoing assessment of hemodynamic status, monitoring of blood culture results, stool studies, and monitoring for clinical improvement. The current guidelines for evaluation and treatment of sepsis maintain aggressive early treatment interventions, with ongoing monitoring and an attempt to prevent septic shock. Admission at a lower level of care status is inadequate to address concerns of severe sepsis.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Foot ulcerations
Treatment: Inpatient admission
The insurer denied coverage for an inpatient admission
The denial is upheld 

The patient is a female with a history of Type I diabetes and foot ulcerations who was recently signed out AMA (against medical advice) from another hospital and placed on oral antibiotics. The patient then went and saw a podiatrist, who told her to go to the emergency room for an admission and IV (intravenous) antibiotics. On presentation to the ED (emergency department) the patient had a pulse rate of 103-109 and a BP (blood pressure) of 152/70. Per the notes made available to me the patient had 2 ulcerations on the left foot measuring 2 cm (centimeter). Furthermore, she had a 4 cm ulceration of the right heel. Labs revealed an elevated WBC (white3 blood cell count) of 11.1. X-rays taken of the right ankle and left foot did not reveal and signs of bone infection. The patients HB (hemoglobin) A1C (diabetes blood test) was 10.8. The patient was started on Zosyn and podiatry and infectious disease were consulted. Despite all attempts made to warn the patient of the risks of her not following the recommendations of the emergency room doctors the patient refused to be admitted and signed out AMA, stating that she wanted to take the medication by mouth at home.

There is extensive research that shows that the majority of skin infections, especially in the case of no co-morbidities can be treated on an outpatient basis1.  In addition, in the case of this patient where there is clear lack of severity, a single dose IV antibiotic could have been attempted, with the patient admitted to observation prior to any further intervention. 

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

The insurer's denial of coverage for an inpatient hospital is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Heart failure, hyponatremia, stenosis of the iliac vein, thoracic outlet syndrome. 
Treatment: Personal care services (PCS) level 2, 8 hours per day, 7 days per week for a total of 56 hours per week. 

The insurer denied coverage for personal care services level 2, 8 hours per day, 7 days per week for a total of 56 hours per week. 
The denial is overturned. 

This patient has extensive medical history associated with functional impairment. She needs help with most daily activities. She lives alone, has no informal support (as per UAS (uniform assessment system)) and relies on personal care services (PCS) for assistance with ADLs (activities of daily living) and IADLs (independent activities of daily living). The patient has been receiving PCS 6 hours per day, 3 days per week; 5 hours per day, 1 day per week; 4 hours per day, 1 day per week (total 27 hours per week). Patient requested (via social worker as designee) increase of PCS to 8 hours per day, 7 days per week (total 56 hours per week), which was denied. An external appeal was requested. 

The most recent UAS provided was reviewed. The functional status report indicates patient was totally dependent for housework; she needed maximal assistance for meal preparation, shopping; extensive assistance for managing finances and medications, stairs, transportation; supervision for phone use. For ADLs, the patient needed extensive assistance for bathing, personal hygiene, dressing upper/lower body, toilet use; limited assistance for walking, locomotion, transfer toilet; setup help for bed mobility; supervision for eating. 

Considering the patient's medical history and functional impairments, caregiver assistance for ADLs and IADLs is medically necessary every day at various times throughout the day to help maintain the patient's health and safety. Without adequate assistance, the patient is at risk for adverse health and safety events, including falls/household accidents; skin damage due to inadequate cleaning with toileting/incontinence; decreased food/fluid intake. 

The UAS and the physician's letter of medical necessity indicate the patient has no informal support for ADLs and IADLs. When informal caregivers are unavailable to provide care on a regular basis, then personal care services are indicated to provide necessary assistance for ADLs and IADLs, as needed; including ADLs that occur at unscheduled and recurring times throughout the day. 

Recommendation is given to approve Personal Care Services, level 2, 8 hours per day, 7 days per week, total 56 hours per week. 

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

The insurer's denial of coverage for personal care services level 2, 8 hours per day, 7 days per week for a total of 56 hours per week is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis.
Treatment:  Dupixent 300MG/2ML SC SOPN (subcutaneous solution pen injector), pre-service.

The insurer denied the  Dupixent 300MG/2ML SC SOPN, pre-service.  The denial is overturned.

The member is a man with severe atopic dermatitis that affects 15% of body surface area. He has tried and failed multiple topical steroids in the past. This is a request for Dupixent.

The patient has severe atopic dermatitis affecting multiple areas of the body. He is a candidate for systemic therapy as the BSA (body surface area) is too large for reasonable control with topical medications. Topical therapies are not appropriate therapy for severe, widespread atopic dermatitis, affecting sensitive areas,  which should be treated with systemic therapy. 

Dupilumab is a monoclonal antibody that inhibits IL-4 (Interleukin 4) and IL-13 (Interleukin 13) signaling by blocking the shared IL-4Ra (Interleukin 4 receptor) and originally demonstrated efficacy in phase 2 clinical trials. In March 2017, it was approved by the US Food and Drug Administration (FDA) for adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It is a subcutaneous injection administered initially at a dose of 600 mg and then every 2 weeks thereafter.

Approval of dupilumab was based on clinical trials investigating dupilumab as monotherapy (SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS). Results from the SOLO 1 and SOLO 2 trials showed 36-38% of patients who received dupilumab had scores of 0 or 1 (clear or almost clear) on the Investigator's Global Assessment scale compared with placebo (8-10%). Additionally, improvement from baseline to week 16 of at least 75% on the Eczema Area and Severity Index (EASI) was reported in significantly more patients who received each regimen of dupilumab than in patients who received placebo.

Given its unprecedented efficacy, dupilumab is now a first-line therapeutic for moderate-to-severe atopic dermatitis. The member has failed topical steroids and calcineurin inhibitors.

Cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil  are not FDA (Food and Drug Administration) approved for use in atopic dermatitis (Insufficient data exists to firmly recommend optimal dosing, duration of therapy, and precise monitoring protocols for any systemic immunomodulating medication. Strength of Recommendation: B Level of Evidence: I or II, depending on agent), while Dupixent is.

Systemic steroids and cyclosporine are not a reasonable long term treatment for moderate to severe atopic dermatitis due to their severe side effect profile.

For the reasons above, Dupixent is medically necessary.

No. The health plan did not act reasonably with sound medical judgment and in the best interest of the patient.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Spinal Stenosis.
Treatment: Ambulatory surgery - lower back surgery.
The insurer denied ambulatory surgery - lower back surgery.
The determination is upheld.

The patient's diagnosis was listed as pain and evidence of spinal cord involvement. Other diagnoses listed include lumbar radiculopathy, lumbar spinal stenosis and lumbar stenosis with neurogenic claudication. Records provided show that the patient had a history of chronic low back pain radiating into the bilateral posterior thighs and bilateral knees with numbness into the bilateral feet. It was noted the patient's magnetic resonance imaging (MRI) showed significant ligamentum flavum hypertrophy at both lumbar (L) 3-L4 and L4-L5 levels. There was moderate to severe canal stenosis at these levels, especially at L3-L4. The ligamentum flavum measured 6.5 to 7.5 millimeters (mm) bilaterally at each level. The pain level ranges from 5-10/10. Medications for pain have included hydrocodone/acetaminophen and cyclobenzaprine. On examination, there was normal motor strength, no specific abnormal findings on the progress note. At that time it was recommended that the patient undergo MILD (minimally invasive lumbar decompression). At issue is whether the requested procedure 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 evidence to suggest that the proposed health service or treatment of ambulatory surgery - low back surgery is likely to be more beneficial than standard treatment options for this patient's condition.

The patient is noted to have chronic back pain and imaging studies showed moderate to severe canal stenosis L3-L4 and L4-L5. The patient was recommended to undergo the MILD procedure, According to evidence-based Official Disability Guidelines (ODG) by MCG guidelines Mild (Minimally Invasive Lumbar Decompression) for Low Back Conditions is "Not recommended. A systematic review found that current evidence does not support the routine use of minimally invasive surgery for cervical or lumbar discectomy. Minimally invasive surgery had no clinically significant advantage in terms of short- or long-term measures of pain or function. Patients who underwent minimally invasive disc surgery had higher levels of nerve root injury, dural tears, and reoperation. According to the authors, surgeons already perform open discectomies through relatively small incisions, so it is not surprising to find that outcomes are no better with minimally invasive discectomies." There is no evidence to suggest that the proposed health service or treatment of ambulatory surgery - low back surgery is likely to be more beneficial than standard treatment options for this patient's condition.