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

Diagnosis: Pancreatitis, alcohol withdrawal syndrome, atrial fibrillation, gastroesophageal reflux disease (GERD), and migraines

Treatment for continued inpatient care at a skilled nursing facility (SNF)

The insurer denied coverage for continued inpatient care at a skilled nursing facility (SNF)

The denial is upheld 

This female with chronic medical problems including atrial fibrillation, pancreatitis, and migraine headaches.  She was admitted to the skilled nursing facility (SNF), for subacute rehabilitation.  Under review is the medical necessity of continued inpatient care at an SNF until discharge.

This was initially appropriate for the SNF subacute rehabilitation level of care (1, 2, 3).  She had functional deficits that were amenable to subacute rehabilitation at the SNF level of care.  The clinical records document evidence of functional improvement and the ability to be safely discharged from subacute rehabilitation at the SNF level of care.  According to the occupational therapy notes, the patient required only supervision to "set up" assistance for activities of daily living including dressing, toilet transfers and bathing/showering.   The physical therapy notes document a similar level of functional improvement. The patient was independent with bed mobility and transfer activities.  She was ambulating approximately 350 feet.  Continued functional improvement could have been obtained via home therapy or as an outpatient.  There were also no acute medical or complicated nursing issues that required continued care in an SNF until discharge.

The healthcare plan acted reasonably, with sound medical judgment and in the best interest of the patient. (Taken into consideration were the clinical standards of the plan, information provided concerning the patient, the attending physician's recommendation and applicable generally accepted practice guidelines developed by the federal government, national or professional medical society, board, and associations.  All decisions are evidence-based).  

From a physical medicine and rehabilitation perspective, as well as within a reasonable degree of medical certainty, continued care inpatient care at a SNF until discharge was not medically necessary.

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

The insurer's denial of coverage for continued inpatient care at a skilled nursing facility (SNF) until discharge at is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Mast Cell Activation Syndrome

Treatment Ketotifen Fumarate POW (powder)

The insurer denied coverage for Ketotifen Fumarate POW (powder)

The denial is upheld

The patient is a female who has chronic urticaria and also has been diagnosed as having mast cell activation syndrome. The patient saw her doctor where it is stated that the patient has been treated for presumed mast cell activation. Medications listed included hydroxyzine, Allegra, ketotifen and omalizumab There is a history of food allergies, mild asthma, and anaphylaxis. Treatment response to ketotifen was stated. Omalizumab lack of response was noted. Cetirizine and ketotifen are listed in the note's end of visit medication list. 4 articles relating to urticaria treatment with ketotifen were also included. The plan denial letter states that the medication is compounded and is not approved by the FDA (Food and Drug Administration) for this indication.  

The references cite efficacy of ketotifen but do not indicate that ketotifen is useful in refractory urticaria. The plan is correct in citing that ketotifen is not approved as a
compounded treatment approved by the FDA for urticaria. UpToDate also states that, "The oral formulation of ketotifen is not approved for use in the United States or many other countries." Thus, the evidence to suggest that ketotifen is superior to other urticaria regimens is weak. A search of Clinicaltrials.gov revealed only one study of ketotifen and "atopic dermatitis" and no results reported. No studies in refractory urticaria were recorded. The Up-to-Date section on treatment of refractory urticaria makes no mention of ketotifen. 

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

The insurer's denial of coverage for Ketotifen Fumarate POW is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Dermatitis. 
Treatment: Dupixent. 

The insurer denied Dupixent. 
The determination is upheld. 

The patient has atopic dermatitis (AD). Per the prior authorization form, she has failed prednisone, mometasone, triamcinolone, tacrolimus and methotrexate. However, there are no medical records provided to substantiate any of these failures. The medication under review is Dupixent. 

The requested health service/treatment of Dupixent is not medically necessary for this patient. 

According to the American Academy of Dermatology Atopic Dermatitis Clinical Guidelines and dermatology literature, the conventional, generic therapies such as methotrexate are effective treatments for the management of atopic dermatitis (1, 2).
Within the peer-reviewed literature, in 2018, Gerbens et al writes "Methotrexate (MTX) and azathioprine (AZA) seem to be effective and safe as maintenance treatments in moderate-to-severe AD up to 5 years" (3) Shah et al 2018 writes "Methotrexate is an effective treatment for moderate to severe atopic dermatitis with an acceptable safety profile. A low dose can be used to control the disease for prolonged periods without significant risk" (4). There are several published studies that show that methotrexate is effective and safe for moderate-severe atopic dermatitis (5-8). There are no unique clinical circumstances to this particular individual that would make it medically necessary. The patient has no true contraindications to the use of the preferred medications. The standard of care agents, such as methotrexate, are appropriate agents for the treatment of the patient's atopic dermatitis. The formulary medications should be tried and failed prior to initiating Dupixent. Therefore, Dupixent is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Asthma exacerbation 

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission

The denial is upheld

Patient is a female with history of asthma. She presented to the emergency department (ED) with complaint of cough, chest tightness, shortness of breath and wheezing.

Vital signs (V/S) at presentation included temperature of 99.8 Fahrenheit, heart rate (HR) 109, blood pressure (BP) 163/85, respiratory rate (RR) 19, and oxygen (O2) saturations 98%. The patient had bilateral (B/L) wheezes heard on lung exam. 

Patient was treated with DuoNebs, Magnesium, Prednisone 60 milligrams (mg) and was placed on bilevel positive airway pressure (BIPAP) on setting 12/6 with fraction of inspired oxygen (FiO2) 50%.

Patient was improving post treatment. She was admitted to the hospital for asthma exacerbation. As per the history and physical (H&P), the patient was speaking in full sentences. She was in no acute distress (NAD). Lung exam revealed B/L wheezes and O2 saturations were 100% on 2 liters (L) nasal cannula (NC).

Patient had white blood cell (WBC) count of 12.5. Electrolytes were within normal limits (WNL). Chest x-rays revealed (CXR) revealed no acute infiltrates.

The patient was treated with intravenous (IV) steroids, Singulair, long-acting muscarinic antagonists (LAMA) and supplemental O2.

Initial venous blood gas (VBG) included pH (acidity) 7.23 / partial pressure of carbon dioxide (PCO2) 67.  

Patient improved with present treatment. Repeat VBG 7.29/PCO2 42 / partial pressure of oxygen (PO2) 60/ bicarbonate (HCO3) 23. By the next day the patient was in NAD and V/S were normal. Lungs were clear. The patient was tolerating oral (PO) and was switched to PO Prednisone. The patient was then discharged home later that day.

This patient did not need acute in-patient hospitalization. She could have been placed in Observation status while diagnostic studies and treatment were initiated. Observation period could be for up to 48 hours.

This patient was afebrile and hemodynamically stable. She started improving with treatment in ED and initial BIPAP. There was no pneumonia or pneumothorax on CXR. The patient was not hypoxic, was tolerating PO, and at the time of admission was able to speak full sentences. The patient remained stable after admission. By the next day the patient was medically cleared for discharge on PO Medications. The patient was in NAD, not hypoxic, lungs were clear, and the patient was tolerating PO.

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

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

Diagnosis: varicose veins.
Treatment: Vein procedure.
The insurer denied the vein procedure.
The health plan's determination is overturned.

The patient is a woman with symptomatic right lower extremity varicose veins and venous insufficiency. She was diagnosed with symptomatic right lower extremity varicose veins and venous insufficiency. The plan for treatment was radiofrequency ablation of her right small saphenous vein. She underwent radiofrequency ablation of the right small saphenous vein.
The patient was seen in follow up and was noted to have persistent symptomatic right lower extremity varicose veins. The provider recommended treatment of her symptomatic right lower extremity varicose veins with stab phlebectomy.

The requested vein procedure is medically necessary in this patient with symptomatic lower extremity varicose veins and venous insufficiency.  She had treatment of her venous insufficiency with radiofrequency ablation of her right small saphenous vein previously. However, she has persistent symptomatic right lower extremity varicose veins.

Treatment of her lower extremity varicose veins with stab phlebectomy is medically necessary and is the standard of care for the treatment of symptomatic varicose veins. The patient will benefit from the treatment.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Rectal cancer
Treatment: Proton Beam Therapy
The insurer denied the proton beam therapy.
The denial is overturned.

The patient is a male with a diagnosis of stage T3N2 (Tumor invades through muscularis propria into subserosa or into non-peritonealized pericolic or perirectal tissues, Metastasis in four or more regional lymph nodes) rectal cancer. Definitive chemotherapy and radiation therapy was recommended, and proton therapy was requested.

Yes, the requested proton beam therapy is medically necessary.

Proton beam radiation therapy is a type of very precise external radiation treatment in which protons are used to treat cancer and other conditions. Compared to photon, a proton beam that is delivered with sufficient energy has a low "entrance dose." A proton beam also has a high-dose "Bragg peak" region, which is designed to cover the entire tumor and there is no "exit dose" beyond the tumor involved in proton radiation therapy. Because of this unique property, proton beam therapy is highly successful in minimizing damage to normal tissue and surrounding organs, resulting in fewer side effects. It is an FDA (United States Food and Drug Administration)-approved procedure and it is not subject to IRB (institutional review board) review.

The total dose planned to provide adequate control is about 54 Gy (gray), which is well above the tolerance dose of the surrounding critical structures such as the bowel, rectum, bladder and kidneys. Because of the proximity to these structures, conventional radiation techniques with photons can result in adverse radiation effects in this otherwise healthy man.

In this case, a proton/photon comparison plan was done. The doses to the bowel and kidneys would exceed tolerance levels with the photon plan, whereas the proton plan was able to reduce the doses to acceptable levels. Proton beam radiation therapy therefore, is medically necessary for this patient at this time.

No, the health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient.

A proton/photon comparison plan was done. The small bowel V15 (volume receiving 15 gray) was 178 cc (cubic centimeters) with photon, which exceeded tolerance, and 108 cc with proton therapy, which was within tolerance. The mean left kidney dose was 27 Gy with photon therapy, which exceeded tolerance, and 11.48 Gy with proton therapy, which is within tolerance. In this case, if photon therapy (with intensity-modulated radiation therapy) were to be utilized, the risk of bowel and kidney injury would be significant. Proton therapy would be able to provide a safe and effective treatment for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Respiratory syncytial virus (RSV).
Treatment: Inpatient admission. 
The insurer denied coverage for an inpatient admission.
The denial is overturned.

This is a male with a history of reactive airways disease who had been sick for one week with a cold virus, sneezing and rhinorrhea. Two days prior to the admission he developed shortness of breath. He was taken by his parent to the emergency room (ER). In the ER he had a chest x-ray which was normal, and he received 2 DuoNeb treatments for wheezing. When the child did not improve, he was transferred to the pediatric ER at another hospital for additional treatment.

In the pediatric ER he was noted to be in significant respiratory distress with a rapid respiratory rate, suprasternal retractions and a pulse oximeter in the low 80s. A test was positive for the RSV virus. He was started on supplemental oxygen, intravenous (IV) fluids and steroids. He received an additional treatment with DuoNeb and then 3 additional inhalation treatments with albuterol. When he failed to respond to the treatment in the ER, the decision was made to admit the child to the hospital with a diagnosis of bronchiolitis for continued treatment with albuterol every 3 hours, IV (intravenous) fluids and 2 liters of oxygen.

The patient was treated appropriately in the ER for an acute episode of wheezing related to the RSV virus, hypoxemia and difficulty breathing. The child has a history of reactive airways disease in the past. When he did not respond to treatment in the ER, and he was noted to have a low oxygen saturation despite oxygen supplementation in the ER it was appropriate and consistent with the standard of care to admit the child to the hospital with a diagnosis of bronchiolitis for ongoing oxygen supplementation and continued bronchodilator inhalation treatment every 3 hours. The child was not stable enough to be safely discharged. 

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 the inpatient admission is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: human immunodeficiency virus (HIV)
Treatment: Home health care
The insurer denied Personal Care Assistance Services: 7 Hours per Day, 5 Days per week (Monday through Friday) - Total of 35 Hours per Week. The health plan's determination is upheld. 

This is a case review for a woman with past medical history of human immunodeficiency virus (HIV), stage 3 chronic kidney disease, hypertension, pulmonary hypertension, atrial flutter, morbid obesity with body mass index (BMI) > 50, type 2 diabetes, lumbar radiculopathy, obstructive sleep apnea, bipolar disorder, and chronic obstructive pulmonary disease (COPD). The patient is currently approved for 21 hours per week of personal care assistance level 2, listed as 4 days of 4 hours per day and one day of 5 hours per day. She's requesting an increase to 35 hours per week, 7 hours per day for 5 days each week. 

Personal Care Assistance Services: 7 Hours per Day, 5 Days per week (Monday through Friday) - Total of 35 Hours per Week medically necessary for this patient.
There is insufficient evidence that the requested personal care assistance services 7 hours per day, 5 days per week for a total of 35 hours per week is medically necessary for this patient. Although she has extensive health needs, there is little documentation beyond the UAS in terms of her functional limitations that would require an increase in personal care assistance. There was no specific documentation regarding how this increase could potentially benefit her. Office visits notes from the specialists do not provide any insight as to how additional patient personal care assistance would help her health outcomes or manage her activities of daily living. Without any documentation of medical need beyond the UAS, there is no clear evidence of benefit from increasing the number of personal care hours per week beyond what was determined from the UAS. The notes do reference that she may have been receiving her current 21-hour allotment over 3 days, 7 hours per day. This is likely to be less satisfactory than the 5-day layout as previously outlined, but the notes state that she can contact the health agency to arrange for more suitable distribution of hours.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Alpha 1 Antitrypsin (AAT) deficiency

Treatment: Prolastin C

The insurer denied coverage for Prolastin C
The denial is upheld

The patient has a history of Alpha 1 Antitrypsin (AAT) deficiency, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea (OSA). The patient also carries a diagnosis of anxiety, depression, gastroesophageal reflux disease (GERD), and obesity. She uses continuous positive airway pressure (CPAP) and 3 liters of oxygen (O2) for OSA.

The patient was prescribed Prolastin C for her AAT deficiency. As per physician notes, she was seen for some symptoms of increasing shortness of breath (SOB). The patient was in no acute distress (NAD). Her lungs were clear.

Other diagnostic studies included a computed tomography (CT) of the chest did not reveal any lung pathology.

The AAT level was reported as <25 mg (milligrams) /DL (deciliter). The patient had ZZ (gene variant) Allele.

A pulmonary function test (PFT) showed forced vital capacity (FVC) 2.87, 88%, forced expiratory volume (FEV) 12.2 and 85%, FEV1/FVC 77%. Lung volumes were normal. DLCO (diffusing capacity of the lungs) was normal.

There was no evidence of obstructive airway disease on the PFT. 

The patient has low levels of AAT but in the absence of documented obstructive airway disease there is no indication for AAT supplementation. She should continue with yearly monitoring of PFT's and if there is documented obstruction then replacement therapy would be indicated.

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

The insurer's denial of coverage for the Prolastin C to treat Alpha 1 Antitrypsin Deficiency is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic dermatitis

Treatment is 300 milligrams (mg) of Dupixent once a week

The insurer denied coverage for 300 milligrams (mg) of Dupixent once a week
 
The denial is overturned

The patient has a diagnosis of severe atopic dermatitis who has failed numerous topical therapies. The patient has been treated with Dupixent 300mg (milligrams) SQ (subcutaneous) every 2 weeks. The request is for Dupixent 300mg SQ weekly.  

Based on the current peer-reviewed literature, Dupixent weekly is medically necessary. The patient has tried and failed biweekly Dupixent.  In 2019, Thibodeaux et al published "A review of dupilumab in the treatment of atopic diseases." in which they demonstrated that weekly dosing of Dupixent had significant efficacy (1).  Beck et al also have reported on the efficacy of weekly Dupixent in "Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis" (2). Therefore, it is appropriate, based on the patient's clinical findings and refractory disease, to approve weekly Dupixent in this patient.

The unique clinical circumstances to this particular individual that would make it medically necessary is that the patient is not currently controlled with biweekly Dupixent. Therefore, weekly Dupixent is warranted in this case.  

The insurer's denial of coverage for 300 milligrams (mg) of Dupixent a week is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alzheimer's dementia
treatment: personal care assistant services
The insurer denied Personal Care Assistance services 24 hours 7 days per week (live-in). The health plan's determination is overturned. 

The patient is a male with a past medical history of Alzheimer's dementia, Parkinson's disease, urinary incontinence, wheelchair-bound status, diabetes mellitus type 2, osteoarthritis, hyperlipidemia, congestive heart failure (CHF), history of transient ischemic attack (TIA), hypertensive chronic kidney disease, gastroesophageal reflux disease (GERD), benign prostatic hyperplasia (BPH), constipation, spondylosis of the lumbar spine with radiculopathy and insomnia who had been assigned PCA (personal care assistant) services.

Personal Care Assistance services 24 hours 7 days per week (live-in) were medically necessary for this patient.
There is documentation of the medical necessity of increased PCA services both by the patient's neurologist and primary care physician. There is also documentation of worsening physical and cognitive functioning. The recent assessment underestimated the care needs of the patient with multiple tasks incorrectly noting an improvement in tasks of managing medication, phone use, stairs, transportation, dressing the upper body, locomotion, transfer toilet, bed mobility, and eating when compared to the previous assessment. The patient has 24-hour care needs and therefore a task-based assessment should not have been utilized in calculating the patient's hours. Furthermore, the patient has unscheduled and unpredictable care needs that span a continuum of time and the insurer failed to document a plan to meet these unscheduled and unpredictable care needs. The requested increase in PCA services is not solely for safety and supervision but to assist the patient with the safe completion of activities of daily living (ADL) and Instrumental activities of daily living (IADL). The patient's care needs cannot be met solely with adaptive equipment and medical supplies. The insurer incorrectly assumed the patient had informal support outside of all of the hours he did not have assigned PCA services but the patient's daughter was unable to continue to provide informal support due to her medical issues. Taking into account the clinical standards, all information provided regarding the patient, the attending physician's recommendations, and the applicable and generally accepted practice guidelines, PCA services 24 hours/day, live-in, 7 days/week, are medically necessary for this patient.