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

This is a patient with a left tonsil squamous cell carcinoma. He had a resection with neck dissection that revealed a stage tumor (T) 2 nodes (N) 1 metastasis (M) 0 squamous cell carcinoma with negative margins with large cervical lymph node metastases with extra capsular extension. Radiation therapy with concurrent chemotherapy are recommended to attempt long term control and the proton beam approach is requested. At issue is the medical necessity of proton beam radiation therapy.
The health plan's determination is upheld.

The requested health service or treatment of proton beam radiation therapy for head and neck cancer is not considered medically necessary for this patient. This is a patient with a left tonsil squamous cell carcinoma. He had a resection with neck dissection and radiation therapy with concurrent chemotherapy are recommended to attempt long term control. There is a lack of any significant randomized trials published in peer reviewed literature supporting the benefits of proton beam radiation over photon beam radiation or the safety of proton beam radiation for this diagnosis. Additional randomized trials are needed as recommended by the cited literature below to determine the efficacy and safety of proton radiation for this patient's clinical scenario. Therefore, the requested service/treatment is not medically necessary.
Appeal type: Formulary Exception
Decision: Overturned

Digestive System/Gastrointestinal
Pharmacy/Prescription Drugs

The patient is a male with Ulcerative Colitis. He started sulfasalazine 2000 milligrams (mg) twice daily with severe indigestion, nausea, and abdominal pain. He started mesalamine 1.2 g (grams) tablets with nausea and abdominal pain. He failed Canasa 1 g suppositories. He has had good control of disease on Lialda and more recently, Apriso, without adverse effects. The coverage is requested to continue Apriso for the treatment of Ulcerative Colitis. The formulary alternatives are balsalazide, dipentum, mesalamine DR 400 mg capsules, mesalamine enemas, mesalamine suppositories, mesalamine DR 800 mg and 1.2 g tablets, sulfasalazine, and sulfasalazine delayed release.

The health plan's determination is overturned. The formulary exception to continue Apriso is supported. The result of changing therapy can be inadequate control by a different formulation which directs the drug to a different part of the gastrointestinal tract. Sulfasalazine is inferior to mesalamine and associated with a higher rate of intolerance in some studies. Additionally, Ulcerative Colitis flares can be induced by salicylate medications, and changing therapy can expose the patient to this risk.
In this case, the patient has had uncontrolled disease or adverse symptoms with multiple 5-aminosalicylate formulations and with sulfasalazine. An exception is supported in this case to continue Apriso as the patient is stabilized on the medication, and a change could potentially cause a destabilization, with complications such as disease flare, toxic megacolon, or need for hospitalization or surgery.
Appeal type: Experimental/Investigational
Decision: Upheld

This is a male patient who was diagnosed with non small cell lung cancer with metastases to right eye, pleura, with a RLL (right lower lobe) mass and thoracic lymphadenopathy. It was EGFR (epidermal growth factor receptor) mutated. He was treated with Tarceva initially. He was changed to Tagrisso when progression was seen and the T790M mutation was detected. He then progressed while on Tagrisso. The Guardant360 Test was ordered and is under review.

The health plan's determination is upheld. The Guardant360 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 National Comprehensive Cancer Network (NCCN) Guidelines recommend the following mutation studies for advanced lung cancer to use in the selection of systemic therapy: EGFR, ALK, ROS1, BRAF, KRAS, PDL-1, RET, MET, Tumor mutational burden, Her2 neu, and NTRK.
Cell-free/circulating tumor deoxyribonucleic acid (DNA) testing should not be used in lieu of a histologic tissue diagnosis. Studies have demonstrated cell-free tumor DNA testing to have compromised sensitivity with up to a 30% false negative rate. Standard for analytic performance characteristics of cell-free tumor DNA have not been established and no guidelines exist regarding the recommended performance characteristics of this type of testing. Such testing can identify alterations that are unrelated to a lesion of interest. The use of this type of testing can be considered in specific circumstances, such as the patient is medically unfit for invasive tissue sampling and, in the initial diagnostic testing, if following pathologic confirmation of a non-small cell lung cancer diagnosis there is insufficient material for molecular analysis. Therefore, in this case, the use of the Guardant360 is not indicated.
Appeal type: Experimental/Investigational
Decision: Upheld

The case involves a male patient diagnosed with metastatic EGFR (epidermal growth factor receptor) gene mutated Non-small-cell lung carcinoma (NSCLC), for which he was initially treated with erlontinib. Subsequently, he was converted to osimertinib after an EGFR T790M resistance gene mutation was appreciated. Unfortunately, the patient was unable to tolerated osimertinib given pneumonitis and the patient's medical oncologist ordered the Guardant 360 plasma biopsy to assist with treatment selection moving forward. The use of the Guardant 360 test is under review.

The health plan's determination is upheld. The Guardant 360 Test is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. In this case, the patient did not exhibit resistance, but rather intolerance to osimertinib. Furthermore, the treating oncologist does not state that a tissue biopsy with molecular profiling is a poor option. In fact, the patient's physician states "pending the results of this test (Guardant 360), it may be reasonable to consider a tissue biopsy of a pulmonary nodule..."
Therefore, the use of the Guardant 360 test is not likely to be more beneficial for this patient in this case.
Appeal type: Experimental/Investigational
Decision: Upheld

This is a male with EGFR (epidermal growth factor receptor) mutated adenocarcinoma of the lung. The patient has been treated with erlotinib but developed T790MN resistance. The patient received osimertinib but has progressed. The Guardant360 has been ordered and is under reviewed.

The health plan's determination is upheld. The Guardant 360 Test 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 use of next generation sequencing gene panels to guide the treatment of patients with lung cancer has not been demonstrated to be of benefit. The assay is question is not Food and Drug Administration (FDA) approved. Several ongoing trials 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. Based on the paucity of supporting data, neither the National Comprehensive Cancer Network (NCCN) nor the authors of UpToDate recommend the use of the Guardant360 assay in this clinical scenario.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Bilateral Lower Extremity Lymphedema
 
Treatment: Leg Pump Device (E0652) and Lower Garments (E0667 or E0669)

The insurer denied the Leg Pump Device (E0652) and Lower Garments (E0667 or E0669). The denial was reversed.   
This is a female patient with a medical history of bilateral lower extremity lymphedema. It was reported that she has had multiple therapies that include skilled physical therapy services, compression stockings and lymphatic draining pumps all of which have failed. She consulted a vascular surgeon to be evaluated for her lower extremity swelling. It was reported that upon initial evaluation the patient reported having been on several basic pumps with failed results. It was now recommend that she utilized compression stockings in conjunction with a Flexitouch lymphedema pump. 

According to the supplied medical records, this patient had a long standing history of congenital bilateral lower extremity lymphedema that was not being adequately treated with traditional lymphatic drainage, or by regular compression stockings, or by basic lymphedema pumps. She also has documented by her Vascular Surgeon that in addition to her lower extremity edema, she also had truncal edema that cannot be treated by the aforementioned lower extremity compression stockings or the massage drainage methods.

Flexitouch can treat the lower extremity symptoms and the truncal edema and is now accepted as the new and best treatment for recalcitrant and persistent lymphedema of the legs and trunk. As such, the insurer did not act reasonably, or with sound medical judgment, or in the patient's best interest.

Based on the above, the medical necessity for the leg pump device (E0652) and lower garments (E0667 or E0669) to treat bilateral lower extremity lymphedema is substantiated. The insurer's denial is reversed.
Appeal type: Medical necessity
Decision: Upheld

This is a patient with polycystic ovary syndrome (PCOS), rheumatic fever, 2 prior right upper extremity (RUE) deep vein thromboses (DVTs) who presented with 1 day of right arm pain similar to the symptoms of her prior DVTs. She had been compliant with Rivaroxaban 20 milligrams (mg) daily.
In the emergency department (ED), her temperature was 98 degrees Fahrenheit (F), with a blood pressure (BP) of 123/86 millimeters of mercury (mmHg), a heart rate (HR) of 94 beats per minute (bpm), a respiratory rate (RR) of 20, and an oxygen saturation of 98% on room air (RA). She appeared comfortable, alert and oriented, breathing comfortably with normal lung sounds, and had no major swelling of the RUE (mild tenderness). A Doppler ultrasound was ordered. The patient declined pain medication. While in the ED, she developed chest pain. A computed tomography pulmonary angiogram (CTPA) found no pulmonary embolism (PE), an electrocardiogram (ECG) was normal. Her RUE Doppler ultrasound found a right brachial DVT (like a prior DVT, unclear if this finding represented a new or old DVT).
The patient was admitted and changed from Rivaroxaban to Enoxaparin. On re-assessment with a venous Duplex on day 1 of admission, no DVT was noted, and a hematology consultation felt this may be consistent with thoracic outlet syndrome. Enoxaparin was stopped. Vascular surgery was consulted; they requested a RUE arterial Duplex study (normal) and recommended outpatient evaluation. She was discharged home off anti-coagulation.
The health plan's determination is upheld.
The patient presented with symptoms initially concerning for a recurrent DVT despite being on anti-coagulation. She did not have a PE, was not hypotensive, did not have uncontrollable pain related to the DVT, and had no organ dysfunction (encephalopathy, hemodynamic instability, respiratory distress or failure, acute kidney injury (AKI)). Were this found to be the case, the recommended treatment is changing to a low-molecular weight Heparin such as Enoxaparin. However, on the first day of admission, she was found to not have a DVT, and her symptoms were felt to possibly be related to thoracic outlet syndrome by hematology. By day 2 of the admission, she was seen by vascular surgery who felt thoracic outlet syndrome was possible and recommended outpatient work-up.
At presentation, she was not severely ill and did not require close, inpatient monitoring or inpatient only treatments. She did not require intravenous (IV) pain medication or any other inpatient only treatment. While she was initially felt to have failed anti-coagulation, she was at low risk of decompensation, was put on the standard treatment for this early, and on the first day of admission was found to not have a venous thromboembolism (VTE) at all. As such, a lower level of care would have been reasonable to facilitate the work-up, but an inpatient admission was not needed.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:Blood disorder, other
Treatment: Inpatient hospital stay
The patient has a medical history of anemia and thrombocytopenia who presented with a pulsating headache, lightheadedness and pre-syncope ongoing. On computed tomography (CT) scan of the head the patient was found to have a right frontal lobe hyperdensity and the magnetic resonance imaging (MRI) scan of the brain demonstrated a right frontal lobe hyperdense lesion representing a hemorrhage versus a cavernous angioma. The patient was also found to have pancytopenia and was admitted for continued neurological evaluation and monitoring of  complete blood counts. The health plan's determination is overturned in whole. Based upon the severity of illness and the intensity of the required therapy, the inpatient level of care was medically necessary. This patient, who has a medical history of anemia and thrombocytopenia was admitted for a right frontal lobe brain hemorrhage with symptoms of a pulsating headache, lightheadedness and pre-syncope. As per the clinical documentation, during all dates of service, the patient was hemodynamically stable, and the oxygen saturation was reported to be greater than 90% on room air and  never in any respiratory distress or have a respiratory rate greater than or equal to 30. However, the MRI scan of the brain demonstrated a right frontal lobe hyperdense lesion representing a hemorrhage versus a cavernous angioma and on a complete blood count found to be pancytopenic (leukopenic, anemic, thrombocytopenic). Based on the MRI results and laboratory work it was felt the patient had a brain hemorrhage and  was admitted to the intensive care unit for every one-hour neurologic checks and the initiation of Keppra for seizure prophylaxis. The frequent neurological evaluation and monitoring of platelets/hemoglobin due to the possible brain hemorrhage required an inpatient hospital stay.
Appeal type: Medical necessity
Decision: Upheld

This is a patient with atopic dermatitis (affected areas are the hands and fingers), treated with over-the-counter (OTC) moisturizers, betamethasone, and, per the provider, Eucrisa and Tacrolimus have been used, as well.  At issue is the medical necessity of Dupilumab (Dupixent).
The health plan's determination is upheld.
The Dupilumab (Dupixent) is not medically necessary.
This patient has not demonstrated an adequate trial and failure to all other standard of care measures for atopic dermatitis, such as aggressive topical measures with emollients and wet-to-dry wraps, bleach baths, and phototherapy, which are considered first and second line therapies for eczema.  Systemics such as cyclosporine can also be used in atopic dermatitis.  Dupixent is not appropriate or medically necessary for this patient.  Standard of care includes phototherapy, which can be a highly effective therapy for hand eczema, and patch testing to rule out possible contact allergens.
Appeal type: Medical necessity
Decision: Upheld

Cancer
Radiation Therapy

This patient is a woman with a colorectal carcinoma post colonoscopy with stent placement and perforation requiring a Hartman procedure. She had chemotherapy with follow up imaging showing liver and lung metastases. She then had additional chemotherapy with follow up imaging showing liver metastatic progression. Proton Beam Radiation therapy is recommended to treat these unresectable liver lesions. This is the subject of this review.

The health plan's determination is upheld. The proton beam radiation therapy is not medically necessary for this patient. There is lack of any significant medical studies published in peer reviewed literature supporting the benefit nor safety of this approach of treatment for liver metastases. The few studies published are phase I studies or studies with very small numbers of patients that show the potential of this type of treatment for this clinical scenario. Additional randomized trials are needed to determine the efficacy and safety of proton radiation for liver metastases. Therefore, it is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Patellar dislocations
 
Treatment:  Inpatient Admission

The insurer denied the Inpatient Admission.  The denial was reversed.   

This is a young female patient with a history of cerebral palsy (CP) and patellar dislocations.  The patient presented to the hospital for elective surgery for right Fulkerson osteotomy and medial patella femoral ligament reconstruction.  The patient's post-surgical course was complicated with vomiting, severe pain, and muscle spasms.  She was treated with medication for pain and received a course of physical therapy.  When the patient was medically stable she was discharged home.  

The medical record demonstrates that this patient underwent a complex and extensive orthopedic surgery.  The patient had previously undergone operations to her knee which also added difficulty to the procedure.  The operation included osteotomy with elevation of tibial tubercle (front aspect of knee) and medial patella-femoral ligament (MPFL) reconstruction to the patella area.  The patient would thus have had drilling to her distal femur and patella, as well.  These bone procedures are associated with significant post-surgical pain.  The medical record indicates that the patient experienced anxiety and ongoing pain that required Valium and intravenous (IV) Toradol on several occasions.  The patient's surgical site required a drain until the date of discharge, which required monitoring.    

Based upon the extent of the completed reconstructive surgery, patient's inpatient admission and length of stay were medically necessary and appropriate.  This type of operation cannot and is not performed in an Ambulatory Surgical Unit (ASU) or outpatient facility.  Thus, observation status would likewise have not been appropriate. 

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

The carrier's denial of coverage for the inpatient hospital services is reversed.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Right upper quadrant pain
Issue under review:  Inpatient admission

Determination:  The inpatient admission was not medically necessary.

The patient is an adult male with a history of gallstones.  He presented to the emergency room department with complaints of right upper quadrant pain. 

The patient had stable vital signs.  His laboratory exam was consistent with a white count of 7.2, Lipase at 238, Bilirubin of 4.0, and elevated liver function test.  Abdominal ultrasound and MRCP (Magnetic Resonance Cholangiopancreatogram) was consistent with cholelithiasis, trace fluid, and gallbladder wall thickening.  There was no evidence of common duct stones or biliary ductal dilatation.

Laparoscopic cholecystectomy was performed, and the patient was discharged in stable condition of the following day.

The patient presented with classic signs and symptoms acute cholecystitis with abnormal laboratory values.  There was no evidence of sepsis or hemodynamic instability.  Operative intervention did not reveal any abdominal abnormalities, and there were no untoward effects after surgery.

After an uncomplicated elective laparoscopic cholecystectomy, patients can drink clear liquids once awake from anesthesia, and their diet can be advanced as tolerated.

Most otherwise healthy, reliable patients with good home support can leave the hospital within six hours after surgery.  Cochrane reviews have found no significant differences for important clinical outcomes for patients discharged the same day versus admitted overnight following laparoscopic cholecystectomy.  A retrospective review of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, which included 15,248 patients older than 65 years of age who underwent elective laparoscopic cholecystectomy, identified congestive heart failure, American Society of Anesthesiologists class 4, bleeding disorder, and renal failure requiring dialysis as significant independent predictors of inpatient admission and mortality. 

The patient could have been treated at a lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Central nervous system /Neuromuscular disorder
Home health care 

The patient with past medical history of coronary artery disease, congestive heart failure, hypertension, hyperlipidemia, Alzheimer's dementia, colon cancer, osteoarthritis and bladder and bowel incontinence.
The patient had assessment tool performed  requesting an increased in consumer directed personal care assistance services (CDPCAS) due to her medical conditions. The health plans determination of medical necessity is overturned in whole . 
 
Yes, requested services of CDPCAS, 24 hours/day, 7 days/week, live in are medically necessary for this patient.
The patient has diagnosis of coronary artery disease (CAD), congestive heart failure (CHF) and osteoarthritis. The patient has history of urinary and bowel incontinence. The patient is treated with oral diuretic therapy with resultant increase in urinary output. The patient is not able to ambulate and is reliant on a walker or a scooter at all times. The patient also has a history of Alzheimer's dementia, however  the  Mini-Mental State Examination (MMSE) was improved from 18/30 to 24/30 at the assessment.
The patient had frequent falls even in the setting of skilled nursing facility. The patient had change in her ability to perform dressing of the lower extremity, walking, locomotion, toilet transfer and toilet use. Based on the  falls that occurred while in skilled nursing facility the patient would need total care with locomotion, transfer of toilet and toilet use. The patient needs total assistance with any locomotion/walking. These activities of daily living would occur at unscheduled times in the evening and overnight hours outside of the 7-hour time frame for CDPCAS. Assistance with these tasks are not for cognitive prompting or for safety and supervision alone.
Appeal type: Medical necessity
Decision: Upheld

Cancer
Radiation Therapy

This patient is a woman with a parotid mucoepidermoid carcinoma staged T3 post resection with pT1N0M0 with positive margins. Radiation therapy is recommended to the surgical bed to decrease the risk of recurrence. Proton beam therapy is being requested and is the subject under review.

The health plan's determination is upheld. The proton beam radiation therapy is not medically necessary for this patient. The requested proton beam radiation for this patient is not the standard of care and is not medically necessary. There is a lack of any significant randomized trials published in peer reviewed medical literature supporting the efficacy or safety of proton beam radiation over photon beam radiation for this clinical scenario. Additional studies are needed to determine the benefits of proton beam radiation over photons for patients with this diagnosis. Therefore, the proton beam therapy is not medically necessary for this patient.