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

Diagnosis: Crohn's Disease. 
Treatment: Stelara at 4-week dosing interval. 
The insurer denied coverage for Stelara at 4-week dosing interval. 
The denial is upheld.  

The patient has Crohn's disease. The patient required a total colectomy with ileo-pouch to anal anastomosis. The patient was treated with Humira but remained with active disease. An endoscopic examination of the pouch revealed ulcerations and moderate stenosis. Recently, the patient was started on Stelara. The patient's doctor wants to give the patient an escalated dose. 

Clinical Gastroenterology and Hepatology 2021 Jan 1 (1): 104-110 has an article titled "Effectiveness of Ustekinumab 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. 

Clinical Gastroenterology and Hepatology 2017;15:1427-1434 has an article titled "Association Between Ustekinumab Trough Concentrations and Clinical, Biomarker, and Endoscopic Outcomes in Patients with Crohn's Disease." The conclusion was that maintaining a maintenance trough concentration of ustekinumab above 4.5 micrograms (ug)/milliliter (ml) was associated with biomarker reductions and an endoscopic response of disease activity. 

This patient has active Crohn's disease and has failed Humira. The patient just started this month on Stelara. Medical literature supports dose escalation to every 4 weeks when the patient is not having a sufficient response to treatment every 8 weeks or when trough levels are low. However, in this case, the patient just started the Stelara and did not have an adequate trial of the standard dosing of every 8 weeks. It has not been demonstrated that the patient was running low serum trough levels of Stelara on the 8-week regimen or having an inadequate response to the standard dose. The health care plan acted with sound medical judgment. Giving Stelara every 4 weeks before the patient has had an adequate trial of the standard dose is not medically necessary. The denial is upheld. 

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 Stelara at 4-week dosing interval is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Blindness
Treatment: Consumer Directed Personal Assistance Services (CDPAS) 46 hours/week
The insurer denied the CDPAS 46 hours/week.
The health plan's determination is upheld.

This is a case review for a female with medical history notable for congenital blindness, loss of hearing in the left ear, and insomnia.

The documentation states that the patient requires total dependence for meal preparation. She requires extensive assistance for housework, finances, shopping, and transportation. She requires limited assistance for stairs. For her activities of daily living (ADLs), she requires supervision only for bathing, hygiene, dressing, locomotion, walking, toilet transfer. She requires set up assistance only for eating and toilet use. A task tool associated with the assessment recommended 15.57 hours/week to address the patient's personal care needs.

The requested Consumer Directed Personal Assistance Services (CDPAS) 46 hours/week is not medically necessary for this patient.

The patient currently receives 20 hours/week of personal care assistance, which is consumer directed. This is approximately 25% (percent) greater than the amount recommended by the task tool. There are no physician letters or personal letters which describe any personal care needs which are not being met at this time. Therefore, it has not been clearly demonstrated that the requested increase in personal care services is medically necessary for the patient.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Overactive Bladder
Treatment: Myrbetriq
The insurer denied: Myrbetriq
The denial is upheld.

The patient is an adult female who was on oxybutynin and suffered blurred vision, light-headedness, loss of consciousness, nausea and palpitations. The patient felt the symptoms were related to oxybutynin. The patient was instructed to stop oxybutynin and request for mirabegron. The request was denied due to not meeting plan criteria - the patient has not met criteria regarding formulary alternatives.

The health plan should not cover the proposed treatment.

This patient had symptoms which are associated with possible adverse effects of anticholinergic medications, i.e., blurred vision, tachycardia, light-headedness. The patient felt the symptoms were associated with oxybutynin and she was instructed to stop the anticholinergic. Other anticholinergic formulary options share the same possible side effects and thus would be contraindicated. The patient has not tried the formulary alternative, Gemtesa (virabegron) which is a beta 3 adrenoceptor agonist and not an anticholinergic. This agent is in the same class as the requested mirabegron.
Appeal type: Medical necessity
Decision: Upheld


Diagnosis: insect bite/fever
Treatment: inpatient stay
The insurer denied the inpatient stay
The health plan's determination is upheld. 

The patient is a young female with a history of von Willebrand's disease type I, and reactive airway disease. She was sent to the pediatric emergency department (ED) by her hematologist for treatment of factor VIII after her mother noticed worsening appearance of a bug bite from the prior day. The bite was on the right side of the face, lateral to the right eye, with initial induration of a few millimeters and erythema. On the day of presentation, the right eye was more swollen, the induration had increased in size, and her lower eyelid had a purple discoloration. 

The inpatient hospital admission was not medically necessary for this patient.
This patient was admitted after experiencing a fever following a factor VIII and von Willebrand's factor blood product administration. While the patient had a fever, she was not hemodynamically unstable, and there was no hemolysis, lung injury, or anaphylactic reaction noted. In addition, her fever could have been related to an underlying infection from the bug bite, not just due to the infusion of the von Willebrand's and factor VIII product. Febrile transfusion reactions are relatively common, and typically do not require a significant level of monitoring or care. In addition, this patient was admitted without intravenous access, with a statement that she was "overall well-appearing and remains stable".
This patient did not have any clinical signs or symptoms that clearly required the acute inpatient level of service. The fever following product administration may or may not have been related to the transfusion itself, and there were clearly no significant concerns for hemodynamic instability given the lack of intravenous access at the time of admission. The patient's care needs could have been safely provided at a lower level of care.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: Hypertension, diabetes and dementia

Treatment: personal care aide (PCA) 24 hours, 7 days x 12 hours x 2 shifts, for a total of 168 hours per week

The insurer denied coverage for personal care aide (PCA) 24 hours, 7 days x 12 hours x 2 shifts, for a total of 168 hours per week

The denial is modified

This is an elderly female with hypertension, diabetes and dementia.  She lives alone in a private residence.  The insurer approved personal care aide (PCA) 63 hours/week and the request is for PCA 24 hours, 7 days x 12 hours x 2 shifts for a total of 168 hours per week; leading to an external review.  

The Uniform Assessment System (UAS) was reviewed.  The patient's cognition is described as severely impaired.  She is reportedly total dependent for completing much of her Instrumental Activities of Living (IADL) tasks including meal preparation, ordinary housework and shopping.  The patient reportedly requires maximal assistance for bathing, personal hygiene, and toilet use.  Extensive assistance is reportedly needed for dressing, toilet transfer, locomotion and ambulation (uses a walker).  Limited assistance is reported needed with eating and bed mobility is independent.  The patient is reportedly incontinent of bladder and bowel.  There has been no reported functional change or falls over the prior 90 days.  The patient's cognitive and functional ability are much the same when compared to the prior UAS report.   

The hospital note describing the patient's hospital course was reviewed.   She was treated with antibiotics for a urinary tract infection and "Her mental status retuned to baseline."  The hospital note does not describe a level of care, medical condition or level of functional incapacity that requires the requested PCA 24 hours, 7 days x 12 hours x 2 shifts for a total of 168 hours per week.  However, her functional limitations do support increasing the current PCA services.  While this physician would also agree that the patient may benefit from additional monitoring; particularly due to her reported cognitive decline, weakness and falls risk, safety monitoring under PCA services does not include monitoring an individual (e.g., with dementia, falls risk, general weakness) when no other Level I or Level II personal care services task is being provided.   Based on the enclosed documents reviewed, the patient's health and safety are more appropriately provided and maintained at home by increasing PCA services 12 hours/day, 7 days/week for a total of 84 hours/week.  

Based on the above, the insurer's denial must be modified. 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 personal care aide (PCA) 24 hours, 7 days x 12 hours x 2 shifts, for a total of 168 hours per week services is not substantiated. However, PCA 12 hours/day, 7 days/week for a total of 84 hours/week is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: cellulitis
Treatment: inpatient stay
The insurer denied the inpatient stay
The health plan's determination is upheld.

This is a case of a male admitted for diagnosis of right third digit/hand ascending cellulitis. The patient presented after a cut on the third finger that bled. The bleeding had stopped but the wound developed redness up to the hand with swelling and local pus. He underwent incision and drainage in the emergency room. Vital signs demonstrated temperature at 99.2F, pulse 65, respiratory rate 18, blood pressure 134/72 and O2 (oxygen) saturation 98%. Physical exam showed ascending erythema, and warmth of the right hand associated with swelling. 

The inpatient hospital admission was not medically necessary.
The patient in this case was admitted for cellulitis of the hand but did not have a red flag condition warranting hospitalization. He did not have toxic shock syndrome, necrotizing fasciitis, joint involvement, involvement of a vascular graft, pyomyositis, gas gangrene or compartment syndrome. He did not have fever, hypotension or tachycardia. He did not have extensive erythema or rapid progression of erythema. He did not have an immunocompromising condition such as neutropenia or use of immunosuppressive medication. He was able to tolerate and absorb oral therapy.
Although the patient required services in the hospital setting the monitoring, diagnostics testing and therapeutic interventions prescribed could have been rendered at a lower level of care. Therefore, the medical necessity of the inpatient admission has not been established.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atherosclerosis of native artery of left leg with intermittent claudication
Treatment: outpatient surgery
The insurer denied outpatient surgery.
The determination is upheld.

This is a male patient who was seen for an initial visit by a vascular surgeon. The patient has a history of coronary artery disease with a prior coronary stent and chronic obstructive pulmonary disease (COPD). He is a current 1/2 pack per day smoker with a 17.5 pack-year history of smoking. The patient complains of bilateral leg fatigue with walking left greater than right (L>) R with an ankle-brachial index (ABI) recorded more than 1 year prior to the visit: right lower extremity (RLE) 1.0 and left lower extremity (LLE) 0.63. Based on the office visit, the provider scheduled the patient for outpatient surgery - endovascular intervention. At issue is the medical necessity of the outpatient surgery.

Based on the documentation provided, the requested outpatient surgery is not medically necessary for this patient at this time.
The patient is described in the office note provided, as suffering from bilateral lower extremity (BLE) disabling claudication L>R but the ABI reported for the right leg is within normal limits at rest at 1.0. The left leg ABI is abnormal at rest, 0.63, but no further imaging of the arterial perfusion of the left leg is performed. The office note mentions that "additional evaluation with a computed tomography (CT) angiogram may be helpful," but there is no documentation provided that this CT study was performed.
The patient is not described as suffering from rest pain or tissue loss in his feet and there is no absolute indication for an angiogram with endovascular intervention. Disabling claudication is a relative indication for endovascular intervention after the patient has failed conservative therapy. Based on the Society for Vascular Surgery (SVS)/American Heart Association (AHA) /American College of Cardiology (ACC) guidelines, conservative therapy for disabling claudication consists of an exercise program, with or without supervision, and an attempt at smoking cessation. There is no mention in the patient's documentation provided that there has been any attempt at this conservative therapy. Without an attempt at conservative therapy, endovascular invasive treatment is not warranted at this time.
There is no indication in the documentation provided that conservative therapy of exercise and smoking cessation has been attempted. Also the right leg ABI is within normal limits based on the documentation provided and thus, it is not clear that there is significant arterial occlusive disease on the right leg that would explain the patient's complaints of right leg fatigue with walking.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: coronary artery disease, hypertension and depression

Treatment: Personal care worker (PCW) service 7 days per week, 12 hours per day; 84 hours per week

The insurer denied coverage for personal care worker (PCW) service 7 days per week, 12 hours per day; 84 hours per week

The denial is upheld.

 
This is an elderly female with chronic medical problems including coronary artery disease, hypertension and depression.  She lives alone in a 1-bedroom apartment.  The patient requested an increase personal care worker (PCW) service from 49 to 84 hours/week, denied by the insurer; leading to an external review.  

The Uniform Assessment System (UAS) report was reviewed.  The patient's cognition is described as modified independent.  The patient reportedly requires maximal assistance for completing much of her Instrumental Activities of Daily Living (IADL) tasks including meal preparation, ordinary housework and shopping.  She reportedly requires extensive assistance for bathing, dressing and toilet transfer.  Limited assistance is reportedly needed for eating, personal hygiene, bed mobility, locomotion, toilet use and ambulation.  The patient was observed, "transferring and ambulating with a walker and contact guard assistance by personal care worker."  The patient is reportedly frequently incontinent of bladder and infrequently incontinent of bowel.  Her ability to perform activity of daily living (ADL) tasks have reportedly improved over the prior 90 days.  There has been 1 reported fall over the prior 30 days.  The patient's cognitive status is much the same and her functional ability has slightly improved when compared to the prior year UAS report.

The patient's medical condition and physical limitations are not at a level or unpredictable as to require increasing PCW services to 84 hours/week.  The letter from the patient's treating physician, describing her clinical condition and reported need for additional PCW services was reviewed.  The doctor does not provide the associated treatment notes to support his claim of the patient's reported functional incapacity.  

This physician would agree that the patient may benefit from additional monitoring for safety; particularly due to her reported cognitive deficits, weakness and falls risk.  However, PCW services for companion care or safety supervision (e.g., dementia, wandering, falls risk) without the direct provision of ADL task assistance is not a covered service.  Based on the enclosed documents reviewed, the patient's health and safety are appropriately provided and maintained by the currently approved PCW services 49 hours/week.   

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 personal care worker (PCW) service 7 days per week, 12 hours per day; 84 hours per week is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Parkinson's disease
Treatment: Home Health Care (HHC) level 2 Personal Care Services (PCS) increase to 120 hours/week [5 days Personal Care Aide (PCA) split shift]
The insurer denied HHC level 2 PCS increase to 120 hours/week [5 days PCA split shift].
The health plan's determination is upheld. 

The patient is a female with past medical history of macular degeneration, osteoarthritis, Parkinson's disease, dementia, bladder incontinence, chronic obstructive pulmonary disease (COPD), coronary artery disease, atrial fibrillation, diabetes mellitus type 2, hearing loss, and lymphedema who had been provided personal care aide (PCA) services. Per assessment, the patient was assessed at total assistance with task of ordinary housework while maximum assistance with tasks of meal preparation, shopping, and dressing lower body. With tasks of managing finances, managing medication, phone use, stairs, transportation, bathing, personal hygiene, dressing upper body, walking, locomotion, transfer toilet, and toilet use the patient was assessed at extensive assistance.

Home health care (HHC) level 2 personal care services (PCS) increase to 120 hours/week [5 days PCA split shift) is not medically necessary for this patient.

There is no documentation provided of the medical necessity of split shift services. Specifically, there are no overnight care logs documenting specific care needs and specific timing of activities of daily living (ADLs) assistance needs in the overnight hours that would not allow a PCA 5 hours of uninterrupted sleep. There is no documentation of medical necessity of turning and repositioning every 2 hours. 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, the requested services are not medically necessary for this patient.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Atopic dermatitis

Treatment: Adbry

The insurer denied coverage for Adbry

The denial is overturned
 

The patient is an adult female with severe atopic dermatitis.  The patient has failed numerous topical and systemic therapies, including cyclosporine, Prednisone, Stelara, Dupixent, and Cibinqo.  The patient is currently controlled well with Adbry at a dosing regimen of 300 milligrams (mg) every 2 weeks.  The patient's current weight is approximately 93 kilograms (kg). The request is for the current dosing regimen rather than a dosing of 300 mg monthly.   

The patient has severe atopic dermatitis which requires systemic therapy and has failed numerous systemic agents.  The patient is stable on her dosing of Adbry at 300mg every 2 weeks, which is within Food and Drug Administration (FDA) guidelines and the standard of care.  The request for Adbry is supported by the medical literature and specialty society guidelines.  Adbry, at this requested dosing is an effective systemic therapy approved by the Food and Drug Administration (FDA) for the management of atopic dermatitis.  The decision is reversed in whole.  Adbry is approved at the requested dosing for systemic use at the medical discretion of the prescribing dermatologist.  

The carrier's denial of a request for a Formulary Exception for Adbry is reversed.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: coronary artery disease. 
Treatment: home health care. 
The insurer denied Personal Care Services: 24 Hours per Day, 7 Days per Week (Live-In). 
The health plan's determination is overturned. 

The patient is a male with a past medical history of coronary artery disease, congestive heart failure (CHF), bladder incontinence, history of melanoma of the scalp with metastases to the lung, status post resection, diabetes mellitus type 2 with neuropathy, atrial fibrillation on chronic anticoagulation, hypertension, degenerative joint disease (DJD), and anxiety who had PCA (personal care assistant) services. 

Personal Care Services: 24 Hours per Day, 7 Days per Week (Live-In) are medically necessary for this patient. 
There is documentation of the medical necessity of increased PCA services from the patient's medical providers. There is documentation from the plan's assessment of extensive assistance with tasks of walking, locomotion, transfer toilet, and toilet use which are 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. In addition, since the time of his assessment, the patient had a fall with a hip fracture and non-ST elevation myocardial infarction (NSTEMI) with subsequent hospitalization for surgical correction and rehabilitation stay. The insurer denied coverage stating there was no medical necessity for increased PCA services specifically noting the patient had requested PCA services for companionship due to anxiety with being left alone. However, PCA services would not be for safety and supervision but to assist the patient with safe completion of activities of daily living (ADL) and Instrumental activities of daily living (IADL). In addition, the patient's care needs cannot be met solely with adaptive equipment and medical supplies. There is also documentation that the patient does not have any informal or formal support outside of PCA services. 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, the requested are medically necessary for this patient. Personal care services are medically necessary when assistance with nutritional and environmental support functions is essential to the maintenance of the patient's health and safety in his own home.