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

Diagnosis: Cerebral infarction

Treatment: alternate level of care in skilled nursing facility

The insurer denied coverage for alternate level of care in skilled nursing facility

The denial is upheld

 
The patient is an adult with chronic medical problems including cerebral infarction, hypertension and heart disease. The patient was admitted to Fort Tryon Center for Rehabilitation and Nursing for cerebral infarction with associated left hemiparesis. The patient's discharge was delayed due to necessary home repairs.  The medical necessity for alternate care in skilled nursing facility is under review.

The patient was initially an appropriate candidate for the skilled nursing facility (SNF) subacute rehabilitation level of care (1, 2, 3). However, it is agreed with the insurer regarding the lack of a prospective Patient Review Instrument (PRI), mutually approved safe discharge plan and justification for the lack of an executed prospective document.  The requested alternate level of care can only be considered prospectively.  The facility justification that the "Alternative level care (ALOC) was not able to be requested on time due to staffing shortage due to sickness" does not rise to a level of an extenuating circumstance to support the medical necessity of the retrospective submission.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for alternate level of care in skilled nursing facility is not substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Cardiac/Circulatory Problems/Arrhythmia/Irregular Heart Rhythm/Paroxysmal atrial fibrillation.
Treatment: Pharmacy/Prescription Drugs/Multaq
The health plan denied the requested prescription drug Multaq, as not medically necessary. 
The health plan's determination is overturned.

The patient is a man with symptomatic paroxysmal atrial fibrillation and a structurally normal heart. Coverage for Multaq (Dronedarone) is at issue.

I overturn, in whole, the health plan's determination that Multaq is not medically necessary in this instance.

The formulary drug, Amiodarone, is likely to be more effective than Dronedarone in this instance. However, the increase in efficacy would come at an increased risk for serious adverse effects.
The formulary alternative to Dronedarone is Amiodarone. Both drugs have proven effective, as compared to placebo, in preventing atrial fibrillation (AF) recurrence in patients with paroxysmal AF. Amiodarone is a Class III antiarrhythmic drug (AAD). Compared to other available AADs, including Dronedarone, it is more efficacious in preventing arrhythmia recurrence in patients with paroxysmal AF. However, its extracardiac side effect profile, including serious pulmonary, neurologic and hepatic side effects as well as both hypo- and hyperthyroidism, limits its use to some degree. Dronedarone, is a noniodinated congener of Amiodarone. While it is somewhat less efficacious than Amiodarone, because of the molecular and structural differences between Dronedarone and Amiodarone, in particular the deletion of the iodine molecules which are present in Amiodarone, the incidence of serious side effects is less. In the meta-analysis reported by Piccini et al, while Amiodarone was superior to Dronedarone in prevention of recurrent AF, Amiodarone was associated with a greater incidence of adverse events leading to discontinuation. Likewise, Freemantle et al, in a mixed treatment comparison of several AADs including Dronedarone, found that Amiodarone had the largest effect in reducing AF recurrence but was associated with the highest rate of patients experiencing at least one serious adverse event and treatment withdrawals due to adverse events.
In two randomized controlled trials evaluating the efficacy of Dronedarone in maintaining sinus rhythm in patients with paroxysmal AF, Dronedarone significantly reduced the risk of recurrence of AF compared to placebo. 
In summary, given the increased risk for serious adverse events with Amiodarone, as compared to Dronedarone, as well as its proven efficacy, it is reasonable to choose Dronedarone as a first-line option in this instance.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Stelara 90 mg (milligram) syringe every 4 weeks
The insurer denied coverage for Stelara 90 mg syringe every 4 weeks.
The denial is overturned.

The patient has Crohn's disease and has required a small bowel resection. He had an enterovesical fistula. He subsequently required an ileostomy but then had closure of the ileostomy. For six years he had been on adalimumab (Humira). He developed antibodies to the adalimumab. He started on Stelara approximately three years ago receiving doses every 8 weeks. A colonoscopy showed active inflammation in the terminal ileum. His Stelara was increased to every 6 weeks. A colonoscopy was done more recently and showed multiple ulcers that were seen at the terminal ileum. His physician is now requesting to increase the Stelara dose to every 4 weeks.

Clinical Gastroenterology and Hepatology 2021 Jan 19 (1 ): 104-110 has an article titled "Effectiveness of Ustekinumab (Stelara) Dose Escalation in Patients with Crohn's Disease." Data was studied from patients who initially received ustekinumab every 8 weeks and then had their interval shortened to every 4 weeks. The conclusion was that shortening the ustekinumab dose to every 4 weeks, in patients who did not respond to dosing every 8 weeks, improved clinical and biological indices of disease activity. It was noted that dose interval shortening was effective and safe.

This patient has Crohn's disease that is not adequately controlled on the current Stelara dose. Dose escalation of Stelara is supported in the medical literature. The FDA (Food and Drug Administration) has approved a dosage of Stelara of 90 mg every 8 weeks. However, giving Stelara every 4 weeks has been shown to be both effective and safe.

The patient is a good candidate for Stelara every 4 weeks since he has not responded adequately to the every 6 week dosing.

Since he has already failed Humira and has not adequately responded to the current dose of Stelara, it is appropriate to try a higher dose of Stelara. It is likely to be more effective than continuing the Stelara dose every 6 weeks.

In summary, the denial of Stelara 90 milligram (mg) syringe every 4 weeks and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Obesity
Treatment: Ozempic
The insurer denied the Ozempic.
The determination is upheld.

This is a female patient with a history of obesity. She is requesting coverage for Ozempic. The medical records included in the information provided clearly document a diagnosis of obesity. There is no evidence that the patient is suffering from diabetes. The plan language stipulates that Ozempic is a covered medication for the treatment of diabetes.  At issue is the medical necessity of Ozempic.

The requested health service/treatment of Ozempic was not medically necessary for this patient. Although Ozempic is Food and Drug Administration (FDA) approved for the treatment of obesity, there are other options available for the treatment of obesity. In this situation, there is insufficient clinical trial evidence to support overriding the plan's criteria requiring a diagnosis of diabetes. Therefore, based on the standard of care, as well as the peer reviewed literature cited in the references, the Ozempic was not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Right hip pain
Treatment: hip magnetic resonance imaging (MRI) (right)
The insurer denied coverage for hip magnetic resonance imaging (MRI) (right)
The denial is overturned.

This is an adult with a history of bilateral hip pain and fibromyalgia. The patient presented to the Orthopedist's office for hip pain. The patient tried and failed physical therapy (PT). An x-ray of the hips revealed no significant findings. The physician requested coverage for magnetic resonance imaging (MRI) of the hip. 

The medical records show difficulty in defining the pain generator. Several diagnoses have been proposed over years. The important factors are there is evidence of hip pain. It has been reported to the lateral and groin area. There is documentation of functional loss. Courses of PT have been provided. Physical examination was remarkable for limited motion. X rays did not show any specific abnormality. A differential diagnosis included possible labra tear. There should be consideration for stress fracture as well. Advanced imaging would be beneficial in obtaining additional information. Treatment recommendations would depend upon the special studies. The MRI/arthrogram would thus be necessary at this time. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for hip magnetic resonance imaging (MRI) (right) is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Arthritis, dislocation of cervical C6/C7 vertebrae initial encounter, hypertension, obesity, and pulmonary embolism

Treatment: Home Care / Personal Care HHC - Level 2 Personal Care Services, per 15 minutes Increase to 84 Hour(s) per week from 45 Hour(s) per week

The insurer denied coverage for Home Care / Personal Care HHC - Level 2 Personal Care Services, per 15 minutes Increase to 84 Hour(s) per week from 45 Hour(s) per week

The denial is overturned


This elderly female has functional impairment associated with several medical conditions and needs assistance with all daily activities. The patient was living at home with her daughter; but the patient has been residing in a skilled nursing facility (SNF) following hospitalization. 

The most recent Uniform Assessment System (UAS) provided for review indicated that the patient was totally dependent for meal preparation, ordinary housework, managing finances, shopping, stairs, transportation; she needed maximal assistance for managing medications; limited assistance for phone use. Activities for daily living (ADL) report indicated bathing, toilet use, locomotion (wheelchair) was total dependence; walking: activity did not occur during entire period; dressing lower body, toilet transfer: maximal assistance; personal hygiene, dressing upper body: extensive assistance; bed mobility: limited assistance; eating: supervision.

The patient was hospitalized for pulmonary embolism and acute respiratory failure. The patient was also treated recently for bronchitis (nebulizers, antibiotic). 

The patient already had significant functional impairment requiring extensive or maximal assistance when she was hospitalized, and she experienced further functional decline especially with mobility and toileting. 

The patient is dependent for transfers (Hoyer lift is needed for safe transfer). Inadequate incontinence care can cause skin damage (e.g., fungal infection, dermatitis); and increases risk of pressure ulcers and urinary tract infection. Another skin related concern is associated with the patient's obesity which is also associated with increased risk of skin damage (e.g., due to excess moisture in skin folds). Incontinence can exacerbate this problem around the groin and buttocks area.

The patient needs a caregiver through the day to assist with pressure relief and incontinence care to help prevent pressure ulcers. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Home Care / Personal Care HHC - Level 2 Personal Care Services, per 15 minutes Increase to 84 Hour(s) per Week services is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hypertension, diabetes, coronary artery disease, arthritis, sciatica, joint pain, depression, colon cancer, memory loss, and urinary incontinence.
Treatment: Increase Personal Care Worker (PCW) Services From 28 Hours Per Week To 49 Hour Per Week
The health plan denied Increase Personal Care Worker (PCW) Services From 28 Hours Per Week To 49 Hour Per Week. The denial is overturned.

The patient is an elderly female. Her medical conditions include hypertension, diabetes, coronary artery disease, arthritis, sciatica, joint pain, depression, colon cancer, memory loss, and urinary incontinence. Denial of increase personal care worker (PCW) services from 28 hours per week to 49 hour per week is being appealed. The health plan approved PCW (personal care worker) services 7 days, 5 hours per day, for a total of 35 hours per week.

Uniform Assessment System (UAS) evaluation completed this year shows modified independent cognition and functional status: total dependence with housework; maximal assistance with meal preparation, and shopping; extensive assistance with managing finances and medications, bathing, personal hygiene, dressing, and toileting; and limited assistance with phone use, walking, locomotion bed mobility, and eating. The patient has bowel and bladder incontinence. Compared to UAS (Uniform Assessment System) evaluation completed nine months ago, there has been a decline with housework, managing finances and medications, personal hygiene, upper body dressing, toilet transfer, and bed mobility.

A letter from one of the patient's providers notes the patient has constant pain and is unable to walk and complete ADLs (activities of daily living). She has progressive memory loss, and her conditions have declined over the past few months. She uses a rollator. She has recurrent falls. She is home bound. She has urinary incontinence and requires frequent assistance with changing and cleaning. She needs more supervision and more assistance with ADLs (activities of daily living).

A letter from another provider notes the patient has rapidly deteriorating mental and physical health. She requires assistance with ambulation. She has cognitive impairment due to dementia. She has multiple medical conditions, including urinary incontinence. She requires assistance with multiple daily changes of soiled diapers. She is a high fall risk. She requires supervision, reminders, and assistance with ADLs (activities of daily living).

The patient requires assistance with all ADLs (activities of daily living), including multiple diaper changes due to incontinence. The information provided shows that this patient has significant limitations in functioning that cannot be met with the approved PCW (personal care worker) of 35 hours per week. The requested increase to 49 hours per week is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Obstructive sleep apnea (OSA). 
Treatment: continuous positive airway pressure (CPAP) device. 
The insurer denied coverage for the CPAP device. 
The denial is upheld. 

This patient is an adult female who was diagnosed with obstructive sleep apnea (OSA) after a sleep study. The patient had an apnea hypopnea index (AHI) of 17.1. She was prescribed continuous positive airway pressure (CPAP). 

No other medical notes were provided except she stated that the CPAP hose was not working properly and also that the ramp was not functioning properly. Apparently, the patient took the machine to vendor. 

No other notes are available from the vendor or her doctor as to what is exactly wrong with the machine and why it cannot be repaired. The patient's machine is relatively new, about 6 months old. 

Coverage for a new machine was denied due to lack of complete information. 

Full details need to be provided about what is wrong with the machine and why it is beyond repair (considering that it is only about 6 months old and most machines function for at least 5 years). 
Moreover, there was no clarification as to why the machine was not covered by warranty.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for continuous positive airway pressure (CPAP) device is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal pain and vomiting
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission.
The denial is upheld.

The patient has a history of Crohn's Disease, Celiac Disease, bowel resection, and fibromyalgia. She presented with abdominal pain and vomiting. She was afebrile and the vital signs were stable. There was no abdominal rebound or guarding. Computerized tomography (CT) scan showed a fluid collection and ovarian cyst. A Gynecological consult was obtained. Magnetic resonance imaging (MRI) showed a multicystic right adnexal lesion. No surgical interventions were advised at this time. It was felt that the patient did not have a flare of Crohn's Disease. An outpatient workup was advised. 

Medical necessity was determined using Milliman Care Guidelines (MCG) M-05 for Undiagnosed Abdominal Pain. Clinical indications for admission include hemodynamic instability, peritoneal signs, intestinal obstruction or perforation, bacteremia, and an inability to maintain oral hydration after observation care. The patient did not have these conditions. 

This patient had abdominal pain. She did not have intestinal obstruction or a flare of her IBD (inflammatory bowel disease). She was diagnosed with a multicystic adnexal lesion and required a magnetic resonance imaging (MRI) and Gynecological evaluation. However, this could have been done with observation care. No acute interventions were needed. She did not meet Milliman Care Guidelines (MCG) criteria for admission for Undiagnosed Abdominal Pain. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for inpatient admission is not substantiated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Pulmonary Embolism
Treatment: Pradaxa
The insurer denied Pradaxa.
The determination is upheld.

This is a female patient with a recurrent thrombosis. The patient has not been documented to have failed any anticoagulants. The patient is currently on Pradaxa, which is not on the formulary. At issue is whether Eliquis or Xarelto will be or have been ineffective, would not be as effective as the non-formulary drug, Pradaxa, or would have adverse effects.

Neither Xarelto nor Eliquis have been demonstrated to be inferior to Pradaxa. The included documentation does not indicate that this patient is intolerant of either of the formulary alternatives nor that she has failed them. Similarly, there is a paucity of documentation indicating that this patient has a contraindication to the formulary alternatives. Neither the authors of UpToDate nor the peer-reviewed literature recommend one of these agents as being superior to another and thus, given their relative equivalency, the formulary options are reasonable and would not have adverse effects that the non-formulary alternative would.
Appeal type: Step Therapy
Decision: Upheld

Diagnosis: Dry eyes
Treatment: Restasis
The insurer denied Restasis. 
The health plan's determination is upheld. 

The patient is a male with dry eyes for whom coverage of Restasis (cyclosporine) 0.05% is the subject of review. Reportedly, the patient has been using it with good effect for at least 4 years. Coverage was recently denied as not medically necessary per Step Therapy Policy as documentation was not provided that the patient could not use generic cyclosporine 0.05% and Xiidra (lifitegrast) 5%. No clinical records are received from the provider.

Restasis is not medically necessary for this patient. 
The Preferred Practice Patterns of the American Academy of Ophthalmology recommends the use of topical cyclosporine (Restasis) or lifitegrast (Xiidra) for patients with moderate to severe dry eye syndrome who have demonstrated inadequate response to ocular lubricants. In this case, the provider has not submitted any clinical records to document what the patient has tried and failed.
While the patient has reportedly been using Restasis for many years, a review of the peer reviewed medical literature does not identify branded Restasis as safer or more effective than lifitegrast (Xiidra) or generic cyclosporine which was approved in February of 2020 consistent with "the FDA's continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts."
Therefore, the requested medication (branded Restasis) is not established as medically necessary. Generic cyclosporine and Xiidra are not contraindicated. Generic cyclosporine and Xiidra are not expected to be ineffective. There is no documentation of the patient having tried the formulary alternatives, generic cyclosporine and Xiidra. No barriers to adherence or compliance are identified with the proposed step therapy.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal Pain
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission.
The denial is upheld.

The patient presented with abdominal pain and vomiting. The patient had a mild tachycardia (elevated heart rate) in the emergency room (ER). There was no abdominal rebound or guarding. There was no leukocytosis. There was elevation of the liver enzymes. A Computed Tomography scan showed liver steatosis and an enlarged gallbladder. There was no evidence of acute cholecystitis. The magnetic resonance cholangiopancreatography (MRCP) was normal. It was felt that the patient could have biliary colic but that the patient did not have acute pancreatitis. The patient was able to tolerate a diet and was referred to the clinic for evaluation for a cholecystectomy.

Clinical indications for admission for Undiagnosed Abdominal Pain. (MCG M-05) include hemodynamic instability, severe pain, peritoneal signs, inability to maintain oral hydration after observation care, and bacteremia. The patient did not have these conditions.

This patient required a workup for abdominal pain and vomiting. This workup, including the MRCP, could have been done with observation status. Intravenous (IV) hydration and antiemetics could have been given in the ER as an outpatient. The patient did not meet Milliman Care Guidelines criteria for admission for Undiagnosed Abdominal Pain. The health care plan acted reasonably and with sound medical judgment. An inpatient stay was not medically necessary.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for the inpatient admission is not substantiated.