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

Diagnosis:  Recurrent/persistent pleural effusion, respiratory failure with hypercapnia, malignant ascites, muscle weakness and cognitive impairment
Issue under review:  7 days per week 24 hours per day (live-in) of personal care aide services

The 7 days per week 24 hours per day (live-in) of personal care aide services are medically necessary.

This is an elderly female with a history of recurrent/persistent pleural effusion, respiratory failure with hypercapnia, malignant ascites, muscle weakness and cognitive impairment.  Due to these conditions, she requires assistance with the majority of her activities of daily living (ADLs).  Per documentation from her Attending Physician, the patient requires extensive supervision to ensure safety with activities of daily living during the day and in the overnight hours.  She is not receiving this type of assistance at the Skilled Nursing Facility, as the staffing is not one to one.  For these reasons, the proposed treatment of seven days per week 24 hours per day (live-in) of personal care aide services is deemed medically necessary for increased assistance with completion of the patient's ADLs.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic dermatitis
Treatment: Dupixent 
The proposed treatment with Dupixent is medically necessary.

The patient has severe atopic dermatitis that warrants systemic therapy. He has failed multiple topical steroids and tacrolimus in the past. He is not a candidate for topical therapies because of the severity of the atopic dermatitis. 

Dupilumab is a monoclonal antibody that inhibits IL-4 and IL-13 signaling by blocking the shared IL-4Ra and originally demonstrated efficacy in phase II clinical trials. In 03/2017, it was approved by the US Food and Drug Administration (FDA) for children (12 to 17 years old) 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 (SC) injection administered initially at a dose of 400 milligrams (mg) and then 200mg every (q) two weeks thereafter (dose: 200mg SC q2wk; start: 400mg SC divided in two sites times one).

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 (n=671) and SOLO 2 (n=708) trials showed 36-38% of patients who received dupilumab had scores of zero or one (clear or almost clear) on the Investigator's Global Assessment scale compared with placebo (eight to ten percent) (P< .001). 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 (P < .001).

Given its unprecedented efficacy, dupilumab is emerging as a first-line therapeutic for moderate-to-severe AD. This patient has failed topical steroids and tacrolimus. Cyclosporine, azathioprine, methotrexate, mycophenolate mofetil are not FDA 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. 

Therefore, Dupixent is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic idiopathic constipation
Treatment: Linzess 

The proposed treatment with Linzess is not medically necessary.

This is a female with Crohn's colitis on Inflectra, and chronic idiopathic constipation. Her constipation has not responded to Miralax or Senna. The provider is requesting treatment with Linzess.

The patient has chronic idiopathic constipation and has failed an osmotic laxative (Miralax) and stimulant laxative (senna).  In order for criteria for Linzess to be met, the patient must also fail a bulk laxative and Amitiza. As the patient has not failed a bulk laxative and Amitiza, and as Linzess has not been shown to be more effective than Amitiza for the treatment of chronic idiopathic constipation, the requested Linzess is not medically necessary.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Type 2 diabetes

Treatment:  Rybelsus 7mg tablet

The insurer denied coverage for Rybelsus 7mg tablet.  The denial reversed.

This patient is a male with type 2 diabetes who is being treated by his primary care physician with Metformin 1000 mg twice a day (BID) and Glipizide 5 g daily.  His A1C level was 8.7%.  His blood sugars range between 188-247, and his body mass index (BMI) is 34.3.  The physician decided to place the patient on Rybelsus 7mg, since the patient has a fear of needles and has a heavy travel schedule.  The insurer denied Rybelsus and presented alternative medications, such as Ozempic, Trulicity, Byetta, and Bydureon that the patient did not try.

Rybelsus was approved by the Food and Drug Administration (FDA) in September 2019 as an oral GLP1 agonist for managing Type 2 diabetes mellitus.  The oral form of semaglutide is Rybelsus.  The other GLP1 agents on formulary are not available in oral form.  While SGLT2 agents are available in oral form, as per Up to Date, "Given the modest improvement in glycemia, ... absence of long-term safety data on the effects of prolonged glucosuria, and absence of cardiovascular data in diabetic individuals without overt cardiovascular disease (CVD), we do not routinely use SGLT2 inhibitors as combination therapy in patients with type 2 diabetes."  In contrast, GLP1 agents have been shown to benefit cardiovascular outcomes in patients with type 2 diabetes.  This supports the use of an oral GLP1 versus a SGLT2 agent. 

An important issue is patient compliance.  The patient has an aversion to needles.  As noted by Bul et al., "One practical barrier to GLP-1 receptor agonist use for some individuals is the need to administer these agents via subcutaneous injection.  For patients unwilling or unable to initiate a GLP-1 receptor agonist for this reason, an alternative may be available in the future-namely, an oral formulation of semaglutide that is currently in phase 3 investigation for the treatment of type 2 diabetes [T2D]."  

Based on the above, the denial for a request for a Formulary Exception for Rybelsus 7mg tablet is reversed.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Prostate Cancer

Treatment:  Genetic testing for prostate cancer

The insurer denied coverage for genetic testing for prostate cancer.  The denial upheld.

This patient is a male was diagnosed with prostate cancer.  He underwent a genetic test for prostate cancer to determine his risk for an aggressive form of that cancer.  His genomic prostate score (GPS) was reported as 17, indicating very low risk prostate cancer.  The insurer has denied coverage for the genetic testing for prostate cancer.  

While it is true that the National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer state that this test can be considered for further evaluation of men with low risk or favorable intermediate risk prostate cancer and at least a 10-year life expectancy, NCCN also notes the absence of randomized prospective trials showing the clinical utility of this test.  American Urological Association (AUA) guidelines regarding management of localized prostate cancer states: "Tissue based genomic biomarkers (such as Oncotype DX) have not shown a clear role in active surveillance for localized prostate cancer, and are not necessary for follow-up."  The impact of tissue based gene expression tests such as Oncotype DX PCA on clinical practice and long-term patient outcomes remains to be empirically demonstrated.  Prospective studies of these tests yielding a true clinical benefit when implemented in clinical practice are still lacking.

The healthcare plan acted reasonably and with sound medical judgment and in the best interests of the patient.  The genetic testing for prostate cancer is not considered medically necessary for this patient.

Based on the above, the medical necessity for the genetic testing for prostate cancer is not substantiated.  The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: COPD exacerbation/congestive heart failure (CHF).  

Treatment: Inpatient admission

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

This patient is a male with a history of chronic obstructive pulmonary disease (COPD), hypertension (HTN), congestive heart failure (CHF), diabetes mellitus (DM), and hyperlipidemia (HLD) who presented to the Emergency Department (ED) with complaints of chest pain and discomfort.  The patient also complained of some shortness of breath (SOB) over prior two days along with swelling of feet. The patient denied any fever or chills. Vital signs at presentation to the emergency department (ED) were: temperature (T) 98.5, blood pressure (BP) 148/95 mm Hg, heart rate (HR) 80, and respiratory rate (RR) 16.  The patient was awake and alert X 3.  Some wheezing was heard on lung exam. The patient was treated with intravenous (IV) Lasix, IV steroids and bronchodilators.  The patient improved following treatment with the same.

The patient was admitted to the hospital for COPD exacerbation/congestive heart failure (CHF). The patient was seen by Pulmonary.  They felt the patient did not have COPD exacerbation. They recommended discontinuation of the oral steroids.  The patient had compensated respiratory acidosis.  Pulmonary function tests (PFT's) and sleep study were recommended as an outpatient.  The patient was discharged home the next day.

This patient did not need acute inpatient hospitalization.  He could have been placed in observation status while diagnostic testing and treatment initiated.  The patient responded very well to treatment in the ED.  The patient was afebrile and hemodynamically stable as per H & P.  The patient was not hypoxic.  The patient was in no acute distress.  Lungs were clear, and WBC was normal.  ABG - compensated Resp acidosis.  Troponin was negative.

The patient was stable for discharge after observation and myocardial infarction (MI) was ruled out with serial cardiac enzymes and EKG as per pulmonary to evidence of COPD exacerbation.  The health plan acted reasonably with sound medical judgment in the best interest of the patient.

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

Diagnosis: Abdominal pain 
Treatment: Inpatient stay 

Summary:
The patient is a male with h/o (history of) IDDM (insulin-dependent diabetes mellitus) on insulin pump, DKA (diabetic ketoacidosis) in 2019 for which he was admitted to the hospital in Florida, and heavy alcohol abuse. He presented to the ED with c/o (complaints of) abdominal pain, nausea and coffee ground emesis, associated with generalized weakness and shakiness. Per the provided records, the patient admits to drinking between six and twelve beers per day, and it is noted that he drank approximately three 12-packs of beer the day of presentation.

As the patient was not hemodynamically unstable and was not in diabetic ketoacidosis (DKA), and as he had no evidence of severe upper GI bleed requiring blood transfusion and close monitoring of his vital signs and blood count, he could have been safely and appropriately managed under a lower level of care without requirement for a telemetry bed. Therefore, the inpatient admission was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

The patient is a female who presented to the hospital for elective removal of her breast implants and mastopexy surgery. She had been suffering from pain in her implants for two years. She was American Society of Anesthesiologists (ASA) class II. Following surgery, she was treated with intravenous (IV) pain medications and antibiotics. Standard post-surgical care with deep vein thrombosis (DVT) prophylaxis was performed. The postoperative check note  does not describe any patient issues or concerns. She was discharged the next day.

The health plan's determination is upheld.

The patient did not have any indications for inpatient admission. Breast implant surgery and mastopexy is not commonly performed as an inpatient procedure. The procedure was elective and, per the operative report, was uncomplicated. The patient was low risk American Society of Anesthesiologists (ASA) class II. She did not have drug related risks. The postoperative note documents stable vital signs and no complications. Her husband was with her and was able to accompany the patient. The patient's pain was managed, and she was ambulating. The patient could have been safely managed at a lower level of care status.
Using Milliman Care Guidelines (MCG) for Ambulatory Surgery, Inpatient stay may be needed unless ALL of the following are present:
1)	Physiologic recovery
2)	Stable vital signs
3)	Patient alert
4)	Temperature appropriate
5)	Activity level appropriate
6)	Operative site appropriate
7)	Postoperative effects resolved or managed
8)	Voiding status acceptable
9)	Competent person available to accompany patient (if required)
10)	No complicating features
The patient met all the above guidelines. Inpatient admission was not required for this breast procedure.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Appendicitis.  

Treatment: Inpatient admission

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

This patient is a male who presented to the Emergency Department after being transferred from another facility. The patient complained of left-sided testicular pain while playing soccer.  The patient had decreased oral intake, nausea and vomiting.  The patient underwent an ultrasound which was positive for appendicitis.  The patient's white blood cell count was 15.  The patient's blood pressure was 138/84. The patient was admitted to the hospital   for surgical intervention.  The patient was treated with intravenous fluids and antibiotics.  The patient underwent a laparoscopic appendectomy on without complications.  The patient was stable and discharged.

The insurer denied coverage for the inpatient services as the patient did not require an inpatient level of care following an ambulatory procedure. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. This patient could have been managed utilizing 23 hour observation, thus avoiding inpatient admission status.  The time from Emergency Room (ER) admission to the onset of surgery was approximately 15 hours, and the total hospital stay was approximately 18 hours.  The patient's history, labs, imaging, and physical findings all suggested a mild appendicitis, and this was confirmed at surgery.  The need for surgery in this case was urgent, not emergent, which can be performed on an outpatient basis in both children and adults.

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

Diagnosis: Chest pain
Treatment: Inpatient admission

The proposed treatment, inpatient admission, was not medically necessary.

The patient is a female that presented to the hospital complaining of mid sternal chest pain for several days.  Upon arrival to the emergency department (ED), she noted dizziness and nausea.  Vital signs were stable and physical examination was unrevealing.  Electrocardiogram revealed no evidence of abnormality and no ischemic findings.  Serial cardiac enzymes were negative.  Relevant past medical history included hypertension (HTN).  The patient was diagnosed with atypical chest pain and ultimately discharged from the hospital.

This patient presented with atypical chest pain and a past medical history of hypertension. Her pretest probability of coronary artery disease is low. (Reference 1)  Utilizing the HEART score she was considered low risk (three points). (Reference 2)  Utilizing the TIMI risk score she also had a low risk of developing major adverse cardiac events in the subsequent 30 days. (Reference 3) Risk assessment of patients presenting with chest pain and no significant ST changes on electrocardiogram (ECG) was reviewed by Hedayati et al. (Reference 3).  Using the HEART score risk stratification schema, this patient would have a low risk of major adverse cardiac events (defined as myocardial infarction [MI], need for percutaneous coronary intervention [PCI], need for coronary artery bypass grafting [CABG], or death) in the six weeks following presentation.  Using the TIMI risk score, this patient would have a low risk of major cardiac events (defined as all-cause mortality, MI, and severe recurrent ischemia requiring urgent revascularization) within the two weeks following presentation.  In conclusion, admission to the hospital to treat an acute cardiac event was not medically necessary. This patient could have been treated at a lower level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Burns to left side of back, upper arm and upper thigh.
Treatment: Inpatient admission

Acute inpatient admission was not medically necessary.

The patient is a male that sustained a six percent total body surface area scald burn to the back, left arm and left thigh. The patient presented by transfer to the hospital. The patient was hemodynamically stable. He did not require fluid resuscitation. The burns were debrided by occupational therapy soon after arrival. Intranasal fentanyl was ordered as a one-time dose for debridement. The wounds were debrided and dressed. All burns are described as partial thickness second degree burns. Following debridement, the patient was ordered for oral analgesia, regular diet, and laxatives. 

Later that morning, the patient was comfortable. Physical therapy saw the patient later that morning and cleared the patient for discharge. The patient was discharged within 12 hours of admission. The care rendered did not require an acute inpatient level of care. The burn was relatively small and the severity of depth was intermediate (partial thickness second degree). The patient could have received treatment at a lower level of care without compromise of quality of care rendered or patient safety. 

The patient had a six percent total body surface area splatter scald burn. None of the reported burns were circumferential or full thickness. All burns were second degree. The patient did not require intravenous narcotic analgesia for pain control. Intranasal fentanyl was the only narcotic given which was for burn debridement; it is usually used for unroofing of the blisters. Burn dressings were applied. The patient did not require fluid resuscitation and is not documented to have had an IV placed. The care the patient received could have been rendered at a lower level of care than acute inpatient without compromise of patient safety or quality of care rendered. In fact, the treatment rendered either as outpatient or observation would have been identical to that which he received. 

In response to the hospital's appeal stating that the physicians determined after initial evaluation that acute inpatient care was reasonable and appropriate to treat the patient, no reason is given as to why the patient failed or did not meet criteria to be treated at a lower level of care. None of the cited treatments including wound care, monitoring of urine output, strict ins and outs, social work consult and oral pain medications required an acute inpatient level of care. In fact, the total hospital time was less than 12 hours from admission until discharge.
Appeal type: Medical necessity
Decision: Overturned

Cancer/other
Nursing Services (including Private Duty Nursing)

This is a female with a medical history of heart failure, hypertension, gastroesophageal reflux disease, hyperlipidemia, osteoarthritis, atrial fibrillation, history of cancer, dyspnea requiring nocturnal oxygen, falls, memory loss, gait imbalance uses a cane and pushing wheelchair. Per the determination of the medical physician and nursing assessments, it was determined the patient met medical necessity criteria for personal care assistance services Level II, 24 hours per day, 6 days per week [Monday through Saturday], Live-In. She would require partial help with activities of daily living such as managing medications, taking transportation, personal hygiene, dressing, toileting, transfers, stairs. In addition, due to memory loss she requires assistance with activities of daily living such as dusting, vacuuming, dishwashing, making beds, laundry, grocery shopping and prepping meals.

The health plan's determination is overturned. The Increase in Personal Care Assistance (PCA) Services: Level II, 24 Hours per Day/6 Days per Week [Monday through Saturday], Live-In is medically necessary for this patient. Per the clinical information provided, the patient has been assessed by her physician and nurse (RN) and per the determination of their assessments, it was determined the patient met medical necessity criteria for personal care assistance services Level II, 24 hours per day, 6 days per week [Monday through Saturday], Live-In. The patient was determined to have a stable medical condition that is not expected to deteriorate suddenly or require frequent medical or nursing care, the patient is self-directing and able to follow commands and make appropriate choices, she would require partial help with activities of daily living such as managing medications, taking transportation (eg. bus, train), personal hygiene, dressing, toileting, transfers, stairs, gait assistance with a cane/push wheelchair and full assistance with activities such as house work (dusting/vacuuming/dishwashing, making beds), laundry, grocery shopping and prepping meals.
Per Guidelines for the Provision of Personal Care Services in Medicaid Managed Care, the patient is eligible for services that are essential to the maintenance of the patient's health and safety in his or her own home. Per the provided clinical information, the patient requires multiple level II services such as; bathing, dressing, grooming toileting, transferring, preparing meals, and administration or prompting of medications. Therefore, the personal care assistance services Level II, 24 hours per day, 6 days per week [Monday through Saturday], Live-In is medically necessary for this patient.