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

Diagnosis: Stroke, dysphagia, heart failure, percutaneous endoscopic gastrostomy (PEG) tube, overactive bladder.
Treatment: Coverage for 5 days per week, 10 hours per day (Monday - Friday) and 2 days per week, 6 hours per day (Saturday, Sunday); 62 hours per week of consumer directed personal assistance services (CDPAS).
The insurer denied coverage for 5 days per week, 10 hours per day (Monday - Friday) and 2 days per week, 6 hours per day (Saturday, Sunday); 62 hours per week of consumer directed personal assistance services (CDPAS).
The denial is overturned.

This is an elderly patient with medical problems that include stroke, heart failure and frequent urinary tract infections. She lives with her daughter (who works full time) in a private residence. The insurer approved consumer directed personal assistance services (CDPAS) 5 days/week, 7 hours/day and 2 days/week 6 hours/day (total 47 hours/week). The request is for CDPAS 5 days/week, 10 hours/day (Monday - Friday) and 2 days/week, 6 hours/day (Saturday, Sunday); 62 hours/week. 

According to the Uniform Assessment System (UAS) report, the patient's cognition is described as "minimally impaired." However, she is totally dependent to maximal assistance for Instrument Activities of Daily Living (IADL) including meal preparation, ordinary housework and shopping. She requires maximal assistance for bathing, lower body dressing, eating and toilet use. She requires extensive assistance for personal hygiene, upper body dressing, locomotion, toilet transfer and ambulation. Her gait is unsteady, and she has fallen over the prior 30 days. She is frequently incontinent of bladder and infrequently incontinent of bowel. Limited assistance is needed for bed mobility.  However, sacral wounds are present. The combination of the patient's clinical condition, physical impairments and recent functional decline support the medical necessity of increasing CDPAS to 62 hours/week. 

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 5 days per week, 10 hours per day (Monday - Friday) and 2 days per week, 6 hours per day (Saturday, Sunday); 62 hours per week of consumer directed personal assistance services (CDPAS) is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Type I Diabetes
Treatment: Ozempic
The insurer denied Ozempic
The denial is: Upheld.

The patient is a male with type 1 diabetes on Medtronic insulin pump. Recently, the Glycated hemoglobin (A1C) is 7.2% (percent).  Body mass index 29 kilograms per square meter (kg/m2). The subject under review is the medical necessity for Ozempic in this case.

This request is for Ozempic for the treatment of type 1 diabetes. The Ozempic prescribing information does not support the use of Ozempic for the treatment of type 1 diabetes. The American Diabetes Association clinical guidelines do not recommend the use of Ozempic for the treatment of type 1 diabetes. The plan alternative Metformin has been studied in type 1 diabetes. The requested Ozempic is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Parkinson's disease, dementia, glaucoma, hypertension, hyperlipidemia, broken right wrist, and osteoarthritis
Treatment: PCA (personal care aide) level 2: 12 hours per day - 7 days a week - a total of 84 hours per week
The insurer denied coverage for PCA level 2: 12 hours per day - 7 days a week - a total of 84 hours per week
The denial is overturned.
 
This is an elderly patient with Parkinson's disease, glaucoma (right eye blind) and dementia. She lives alone in a 1-bedroom apartment. The insurer approved personal care aide (PCA) Level 2: 8 hours/day- 7 days/week (total 56 hours/week). The request is for PCA Level 2: 12 hours/day - 7 days/week - a total of 84 hours/week, which is under review.

The Uniform Assessment System (UAS) report was reviewed. The patient's cognitive skills are described as "Minimally impaired." She is totally dependent to maximal assistance for much of her Independent Activities of Daily Living (IADL) tasks including meal preparation, ordinary housekeeping and shopping. She requires maximal assistance for bathing, personal hygiene, dressing and toilet use. Extensive assistance is needed for eating, bed mobility, locomotion, toilet transfer and ambulation. She is frequently incontinent of bladder and continent of bowel. Her ADL (activities of daily living) status and self-sufficiency have declined and deteriorated, respectively, over the prior 90 days (and when compared to the prior UAS report). The patient's clinical condition, cognitive deficits and functional needs are at a level, unpredictable and significantly declining as to warrant the requested PCA 84 hours/week. Given her functional decline and based on the enclosed documents reviewed, the patient's health and safety can be more appropriately provided and maintained by increasing PCA services Level 2: 12 hours per day - 7 days a week - for a total of 84 hours per week.

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 personal care aide (PCA) level 2: 12 hours per day - 7 days a week - a total of 84 hours per week is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Crohn's disease.
Treatment:  Skyrizi.

The insurer denied coverage for Skyrizi.  The denial is overturned.

The patient has Crohn's enteritis. He was previously treated with steroids and mesalamine. He has a history of cardiac disease. A previous magnetic resonance elastography (MRE) showed multifocal small bowel strictures. He now requires biologic therapy. His physician has now recommended Skyrizi, since it has not demonstrated an increased risk of infection or malignancy. 

The Journal of Crohn's Colitis 2021 Dec; 15(12):2001-2010 has an article titled "Long Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open Label Extension Study." In this study, no deaths, malignancies, adjudicated major cardiovascular events, tuberculosis, or herpes zoster were reported. 

The Food and Drug Administration (FDA) has approved Skyrizi for moderate to severe Crohn's disease. It is an interleukin inhibitor and works by a different mechanism of action than Humira. In the clinical trial showing its efficacy, the overall incidence of treatment-emergent adverse effects was similar in the treatment and placebo groups. Skyrizi was determined to be a safe and efficacious treatment. 

Up To Date has an article titled "Overview of medical management of high-risk, adult patients with moderate to severe Crohn's disease." Risankizumab (Skyrizi) is listed as a treatment option for both induction and maintenance. It has been shown to be effective. The article states that we anticipate using Risankizumab as an alternative to other first line biologic agents. 

This patient requires biologic therapy for active Crohn's disease. His physician advises that due to its different mechanism of action it is a safer alternative with less risk of developing a malignancy. There is no recommendation from the FDA that a patient needs to fail a different biologic in order to receive Skyrizi. Giving Skyrizi is in the best interest of the patient and is medically necessary. 

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 Skyrizi is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Interstitial Lung Disease (ILD).
Treatment:  Mycophenolate Sodium 360 milligrams (mg) OR (oral) TBEC (tablet enteric coated).

The insurer denied coverage for Mycophenolate Sodium 360 milligrams (mg) OR TBEC.   
The denial is overturned

An appeal letter states the patient has rheumatoid arthritis and Interstitial Lung Disease (ILD). The patient does not have mixed connective tissue disease. The patient was managed on Cellcept for years. ILD clinically improved. The patient has marked nausea and decreased appetite with Cellcept. It is medically necessary for the patient to continue using Mycophenolate Sodium.

The patient was seen for a follow up for rheumatoid arthritis and ILD. The patient presents with good control and no signs of activity. The patient reports a decreased appetite and nausea with Cellcept. The treatment plan was to start Myfortic.

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

Mycophenolate Sodium 360 milligrams (mg) OR TBEC is considered medically necessary for this patient.

The patient has a diagnosis of ILD. The patient does not have mixed connective tissue disease. Cellcept is the standard of care for ILD. An immunosuppressant is needed for rheumatoid arthritis associated ILD. This is supported by the medical literature. If Cellcept is not tolerated but effective, then Mycophenolate Sodium is appropriate as an alternative. Therefore, the request for Mycophenolate Sodium is medically necessary.

Brown KK, Rajan SK, Shenoy P, Mehta M, Lopez M, Hegde RS, Gogtay J. (2021), "Though results are limited, immunosuppressants such as MMF (Mycophenolate mofetil) have shown promise as an effective and well-tolerated steroid-sparing agent, providing hope that the limited treatment armamentarium for ILDs can be expanded."

Brito Y, Glassberg MK, Ascherman DP. (2017), "Among the many extra-articular complications of rheumatoid arthritis (RA), interstitial lung disease (ILD) contributes significantly to morbidity and mortality."

Morisset J, Lee JS. (2019), "Although the standard of care for patients with RA-ILD and chronic hypersensitivity pneumonitis is immunosuppression, the optimal treatment for patients with progressive disease and a UIP (Usual interstitial pneumonia) pattern remains unknown."
 
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 Mycophenolate Sodium 360 milligrams (mg) OR TBEC services is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Supraventricular Tachycardia
Treatment: Inpatient Hospital Admission
The insurer denied the inpatient hospital admission.
The health plan's determination is overturned.

The patient is a male who presented to the emergency department (ED) complaining of palpitations, dyspnea, weakness and lightheadedness. His medical history was remarkable for surgical repair of Tetralogy of Fallot, tricuspid valve repair, paroxysmal atrial fibrillation and stroke. In the ED his blood pressure was 156/119 millimeters of mercury (mmHg) with a heart rate of 131 beats per minute. Intermittently his heart rate increased to over 200 beats per minute. Carotid sinus massage was performed. The tachycardia terminated but then re-started. An electrocardiogram showed a supraventricular tachycardia at 242 beats per minute. Intravenous Adenosine was administered and revealed that the underlying rhythm was atrial flutter. Metoprolol was prescribed for rate control. His chest x-ray showed mild interstitial edema. The patient was admitted to the hospital. The patient's rhythm converted to sinus. He remained in sinus rhythm and was discharged.

The health plan, in its determination of medical necessity, did not act reasonably, with sound medical judgment and in the best interest of the patient.

The requested health service/treatment of an inpatient hospital admission was medically necessary for this patient. This patient, with a history of complex congenital heart disease, presented with atrial flutter with ventricular rates as high as 242 beats per minute. The tachycardia terminated but then restarted and required Metoprolol for ventricular rate control. His chest x-ray showed signs of early congestive heart failure. Atrial arrhythmias in patient's post repair of Tetralogy of Fallot are associated with increased incidence of persistent hemodynamic abnormalities and worse long-term cardiovascular outcomes compared to patients without these arrhythmias postoperatively. Given the patient's extremely rapid rates, recurrent tachycardia after initial termination, underlying structural heart disease and evidence of early congestive heart failure, he was at risk for hemodynamic compromise and required careful and continuous monitoring with the ability to intervene emergently, if needed. This warranted an inpatient admission.

The Milliman Care Guideline for supraventricular arrhythmias was provided for review. This patient did not meet the listed criteria for inpatient admission. However, based in the particular circumstances of this case, an inpatient level of care was medically necessary.

The health plan's determination of medical necessity is overturned in whole.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Alzheimer's disease

Treatment: Personal care worker (PCW) services 7 days per week, 24 hours per day, continuous care by more than 1 person; 168 hours per week

The insurer denied coverage for PCW services 7 days per week, 24 hours per day, continuous care by more than 1 person; 168 hours per week

The denial is upheld 

This is an elderly patient with Alzheimer's dementia. She lives with her spouse in a private residence. She was approved for PCW 7 days/week, 24 hours/day, Live-in; 91 hours/week, which the spouse has declined. The request is for 7 days/week, 24 hours/day, continuous care by more than 1 person; 168 hours/week, which is currently under review.

The recent Uniform Assessment System (UAS) report was reviewed. The patient's cognitive skills are described as "Moderately impaired- Decisions consistently poor or unsafe; cues/supervision required at all times." She is totally dependent to maximal assistance for Instrumental Activities of Daily Living (IADL) tasks including meal preparation, ordinary housework and shopping. Maximal assistance is needed for bathing, lower body dressing, and toilet use. Extensive assistance is needed for personal hygiene, upper body dressing, eating, bed mobility, locomotion, ambulation and toilet use. She is incontinent of bladder and occasionally incontinent of bowel.

The patient's functional ability has declined according to her treating physicians and when compared to the prior UAS report. The nighttime activity logs were reviewed and document the patient waking up at night, getting out of bed, and potential falls risk. However, her need for level 1 or 2 services during nighttime hours are not at a level or unpredictable as to require the requested PCW services 7 days/week, 24 hours/day, continuous care by more than 1 person; 168 hours/week. This physician would agree due to safety concerns the patient may actually require additional monitoring for her own safety; particularly at night when she may get out of bed, presents a falls risk and perhaps wander throughout the home. Unfortunately, safety monitoring under personal care services does not include monitoring an individual (e.g. with dementia) when no other Level 1 or Level 2 personal care services task is being provided. Based on the documents reviewed, the approved PCW 7 days/week, 24 hours/day, Live-in; 91 hours/week are appropriate to meet the patient's functional needs.

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) services 7 days per week, 24 hours per day, continuous care by more than 1 person; 168 hours per week is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Breast Cancer.
Treatment: Proton Beam Radiation Therapy.
The insurer denied: Proton Beam Radiation Therapy.
The denial is: Upheld.

The patient is a female with history of breast cancer one (BRCA1) mutation and tumor (T)2 node (N) 3b metastasis (M) 0 (including internal mammary node involvement) left breast cancer status/post (s/p) neoadjuvant systemic therapy followed by surgical resection. The subject under review is the medical necessity for proton beam radiation therapy.

Proton radiation is not medically necessary for this patient.
Proton radiation is not proven to yield superior clinical outcomes in the patient's situation as compared to standard of care photon-based radiotherapy. The provider did not supply a proton/photon plan comparison to show that the patient cannot be treated safely/effectively with photon radiation. The provided plan comparison in the documentation provided is for a case control patient, and not specific to the actual patient in question. The patient does not have a history of prior thoracic radiotherapy nor a genetic/comorbid condition that increases her risk for normal tissue toxicity. A high-quality guideline concluded that "There is no evidence of increased toxicity or contralateral breast cancer ([BC]CBC) events from radiation exposure in BRCA one or two (1/2) carriers." Proton radiation for management of the patient's breast cancer is the subject of ongoing clinical trials (e.g., the Radcomp trial). It is not yet the standard of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Glioma
Treatment: Mektovi 15MG (milligrams) Tablet
The insurer denied the Mektovi 15mg tablet.
The determination is overturned.

The patient has a history of an optic pathway hypothalamic glioma that was diagnosed after she presented with failure to thrive. She had a biopsy of the tumor that showed a pilocytic astrocytoma and molecular testing was positive for KIAA1549-BRAF [B-raf proto-oncogene] fusion. She was given 8 doses of weekly Vinblastine, but she progressed on this treatment with hydrocephalus secondary to the increased size of the tumor. The provider is now recommending treatment with Mektovi (binimetinib), noting that many pilocytic astrocytoma have alterations in the mitogen-activated protein kinase (MAPK) pathways that could be targeted with this medication. The requested medication, Mektovi in this infant is under review for medical necessity.

The requested health service / treatment of Mektovi 15 milligrams (mg) is medically necessary for his patient. In regards to the current standards of care in the field and medical literature, the use the Mektovi is clinically appropriate. The National Cancer Institute (NCI) states that the standard treatments for recurrent low-grade astrocytomas such as this patient's pilocytic astrocytoma may include surgery, chemotherapy and/or targeted therapy with or without chemotherapy. This patient has already tried and failed the use of Vinblastine, and surgery is not an option, given the location of the tumor. Targeted therapy is the only remaining option. The NCI notes that the identification of BRAF mutations driving a significant portion of these tumors has provided a new potential treatment target. These types of medications have resulted in a 41 percent (%) overall response rate to include some complete responses in children with tumors expressing the BRAF mutation such as the one that this patient has. Truong et al has also shown the benefits of targeted therapy in pediatric gliomas, to include the use of Mektovi, and Miller et al showed a volumetric response using this therapy. [5,6]
This patient has limited treatment options for a life-threatening disease. She has tried and failed all other more "standard" treatment options, and the use of Mektovi is supported by her tumor tissue and the current standards of care in the field.
Therefore, based on the clinical information provided for review, and the current peer-reviewed literature/standards of care, the use of Mektovi is medically necessary at this time.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Status post heart transplant
Treatment: Nulojix SOLR (solution reconstituted) 250 mg (milligrams)
The insurer denied Nulojix SOLR 250 mg.
The denial is upheld.

The patient is an adult male with a history of non-ischemic cardiomyopathy who underwent heart transplant two years ago. The donor had renal cell carcinoma. The patient underwent imaging which was negative for renal carcinoma. There was also history of diabetes and chronic kidney disease. The patient was on tacrolimus and prednisone. The patient was treated for COVID (Coronavirus disease) infection last year. Nulojix is under review.

The proposed treatment is not medically necessary.

Nulojix is an immunosuppressant medication utilize for those status post renal transplant. It is also Food and Drug Administration (FDA) approved for this indication. There is thought that it has advantages over tacrolimus by offering decreased risk of nephrotoxicity. However, there is no definitive evidence that this medication has been established as standard of care towards definitively improved cardiac transplant outcomes. It is therefore considered not medically necessary in this case.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: varicose veins
Treatment: Heat Treatment of Main Leg Veins (Endoluminal Ablation of Varicose Veins)
The insurer denied Heat Treatment of Main Leg Veins (Endoluminal Ablation of Varicose Veins). The health plan's determination is overturned.

The patient is a female who reported left leg pain, heaviness, and swelling despite wearing compression stockings. The patient previously underwent laser ablation of the left great saphenous vein of the thigh. An Ultrasound of the left lower extremity was documented in the office note as showing left saphenofemoral junction reflux of 2.87-seconds and the left great saphenous vein dilated to 5.0 millimeter (mm) with > (greater than) 2.28-second reflex from the left distal thigh to the ankle. The patient was recommended to undergo endovenous laser ablation (EVLT) of the left great saphenous vein from the distal thigh to the mid/distal calf portion of the left great saphenous vein.

The requested Heat Treatment of the Main Leg Veins of the left lower extremity is medically necessary for this patient.
The patient has documented symptomatic varicose veins with pain, heaviness, and swelling of the left lower extremity. An ultrasound showed reflux and dilation of the left greater saphenous vein (GSV) from the distal thigh to ankle. Based on the literature, the requested treatment is appropriate for this patient.
A 2020 study by Masuda et al found that it was appropriate to perform GSV ablation for patients with symptomatic C (cervical) 2 disease in the setting of GSV axial reflux. The 2016 Practice Guidelines of the American College of Phlebology recommended with grade 1A that "when patients have a correctable source of reflux definitive treatment should be offered unless it is contraindicated or unwarranted."