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

Diagnosis: Central Nervous System/Neuromuscular Disorder
Treatment: Pharmacy/Prescription Drugs
The health plan denied the requested prescription drug. The health plan's determination is upheld.

This is a male who was prescribed brand name Copaxone.
The patient was seen by his physician. At that time, he was noted to be doing well. He would take an antihistamine when he gets hives. He was sleeping, exercising, and was staying away from carbohydrates. His review of systems was significant for stress. Medical history was significant for hypothyroidism, sleep apnea on continuous positive airway pressure (CPAP), a benign colon polyp that was being removed and lymphoma that was in remission. He had been undergoing daily injections with Copaxone that were tolerated well. He was taking Rituximab in the past. Examination revealed normal mental status, cranial nerve, motor, reflex, sensory and coordination examinations with normal time 25-foot walks. A brain magnetic resonance imaging (MRI) was stable. Diagnosis was relapsing remitting multiple sclerosis. Copaxone and vitamin D were continued, and a new brain MRIwas planned.
A letter of medical necessity from the physician indicated that the patient had been treated with Copaxone  that was effective for him. He had previously been treated with Rituximab earlier and then was switched to Copaxone. He was treated with generic Glatiramer with injection site reactions and diffuse urticaria and lack of tolerance. It was his physician's belief that Glatopa would have the same negative effect as Glatiramer.
At issue is the medical necessity of Copoxone.

The health plan's determination of medical necessity is upheld, in whole.

The patient has had a trial and adverse effects to generic Glatiramer acetate. This adverse effect derives from differences in inactive products associated with the injection. There is no evidence that he would have a similar reaction to a different Glatiramer acetate preparation (Glatopa). The physician is requesting the use of brand-name Copaxone because of an anticipated adverse effect from Glatopa. However, anticipation of a of an adverse effect does not predict its occurrence. There is otherwise no difference in efficacy between Copaxone and other Glatiramer acetate products as supported by current medical literature. Therefore, there is no reason to withhold a trial of Glatopa as the patient may not have an adverse reaction and would otherwise have the same clinical response as he would with Copaxone. There is therefore no specific medical necessity specific medical necessity for brand-name Copaxone currently.
Appeal type: Medical necessity
Decision: Upheld

Other
Radiology Services

This is the case of a female patient who developed pneumonia. The patient had a chest computed tomography (CT) that showed pneumonia with possible right upper lobe nodule. The patient had a repeat chest x-ray a few weeks later that did not show any evidence of pneumonia and did not show any evidence of lung nodule. The patient has no history of smoking. The patient has history of asthma and she is on Symbicort. The treating provider is requesting the coverage of a follow up CT of the chest.
The subject under review is the medical necessity of the CT scan.

The health plan's determination is upheld.

No, the requested service of CT scan was not medically necessary for this patient.
Based on the Fleischner Society a follow up CT chest in patients older than 35 is indicated in the following circumstances:
For single nodules Less than 6 millimeter (mm) and 1) Patient is Low risk - No follow up is needed 2) Patient is at high risk (i.e. smoker) - Optional follow-up exam at 12 months is indicated
For nodules 6 mm to 8 mm or Lung-RADS 3 follow up CT chest is indicated at 6 to 12 months and 18-24 months.
For solitary nodule > 8 mm, follow up CT chest is indicated at 3 months, 6 months, and 18 to 24 months unless diagnostic positron emission tomography (PET)-CT or tissue sampling performed.
This patient had CT chest in last year that showed a lung nodule. The patient is low risk being a non-smoker. The size of the nodule was not given. The repeat chest x-ray (CXR) that the patient had showed complete resolution of the pneumonia and no suspicious lung nodule. It is unclear from the radiology report if the nodule was greater than 8 mm in the first CT chest to require a follow up CT chest at 3 months. The CT chest was not indicated in any case sooner than 3 months.
Therefore, the request for a repeat CT chest was not medically necessary per national criteria.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Skin Disorders
Treatment: Pharmacy/Prescription Drugs
The health plan denied the requested prescription drug. 
The health plan's determination is upheld.

The patient is a female with moderate to severe psoriasis (15% body surface area involvement) of the scalp, hands, and lower extremities. The patient has tried and failed topical Mometasone, Fluticasone, and Salicylic Acid, as well as intralesional Kenalog and oral Otezla.

A request for Skyrizi is under review for medical necessity.

The health plan's determination of the medical necessity of Skyrizi is upheld.

No. Because first line and standard treatments such as Methotrexate have not been tried to date, and despite Methotrexate being medically appropriate for this patient with proper monitoring and counseling, Skyrizi is being prescribed not out of medical necessity but out of patient and/or provider convenience or preference. The patient has no documented treatment failure with, or true medical contraindication to, standard, first-line systemic therapies such as Methotrexate.

Modern dermatology literature [1-4] supports use of the health plan-covered and preferred medications as similarly efficacious to the requested Skyrizi, particularly for a patient with a limited history of systemic psoriasis therapy previously utilized and recommend the use of these preferred agents as appropriate for this patient's clinical scenario. Therefore, as per current medical standards of care, Skyrizi is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Vertigo, cognitive impairment, hypertension, cervicalgia and osteoarthritis
Treatment: Personal Care Aide Level II: 12 Hours per Day - 7 Days per Week, 12 Hours per Day - 7 Days per Week (SPLIT SHIFT) (Total 168 Hours per Week)
The insurer denied the Personal Care Aide Level II: 12 Hours per Day - 7 Days per Week, 12 Hours per Day - 7 Days per Week (SPLIT SHIFT) (Total 168 Hours per Week).
The denial is overturned.

The patient is a male with a history of prostate cancer, vertigo, cognitive impairment, hypertension, cervicalgia and osteoarthritis. Due to impairments related to these conditions, he requires assistance for completion of the majority of his activities of daily living (ADLs). Appeal review requested for potential approval of 12 Hours per Day - 7 Days per Week, 12 Hours per Day - 7 Days per Week (SPLIT SHIFT) Personal Assistance Services to offer increased activities of daily living (ADLs) support.

Yes, the proposed treatment of 12 Hours per Day - 7 Days per Week, 12 Hours per Day - 7 Days per Week (SPLIT SHIFT) Personal Assistance Services is deemed medically necessary. 

This is a male with a history of prostate cancer, vertigo, cognitive impairment, hypertension, cervicalgia and osteoarthritis. Recent documentation from the patient's Neurologist indicates that the patient has demonstrated progressively worsening cognitive impairment, dizziness and gait ataxia. For these reasons, the currently approved plan of 52.5 hours per week Personal Assistance Services is insufficient to meet the patient's current needs. Hence, the proposed treatment of 12 Hours per Day - 7 Days per Week, 12 Hours per Day - 7 Days per Week (SPLIT SHIFT) Personal Assistance Services is deemed medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Endocrine/Metabolic/Nutritional
Durable Medical Equipment

Diagnosis: Diabetes
Treatment: Continuous Glucose Monitor 
The insurer denied the Continuous Glucose Monitor. The health plan's determination is overturned. 

This is a male with type 2 diabetes on multiple daily insulin injections complicated by hypoglycemia and hyperglycemia. He is unable to perform finger sticks to measure glucose due to significant, painful neuropathy. The patient's glycated hemoglobin (A1C) is 11.7%. Request for continuous glucose monitoring is under review.

Durable Medical Equipment: Continuous Glucose Monitor [A9278, A9277, A9276] is medically necessary for this patient.

In a randomized controlled trial, Dexcom continuous glucose monitoring was shown to lower A1C in patients with uncontrolled type 2 diabetes on multiple daily insulin injections (adjusted difference in mean change of A1C with use of continuous glucose monitoring, -0.3% [95% confidence interval (CI), -0.5% to 0.0%]). In a second study of 101 patients with type 2 diabetes on two or more injections per day, use of the continuous glucose monitoring system significantly improved A1C levels. The changes in HbA1c (hemoglobin A1C) were -0.82% versus (vs) -0.33% in the intervention group using the continuous glucose monitoring system and control group, respectively, and 68.6% of the patients in the intervention group using the continuous glucose monitoring system had their HbA1c reduced by 0.5% compared with 30.2% in the control group, and 39.2% had their HbA1c reduced by 1.0% vs. 18.6% in the control group without an increased frequency of hypoglycemia. This patient has uncontrolled type 2 diabetes with an A1C of 11.7% and he is on multiple daily insulin injections. In this clinical situation, as outlined above, the use of CGM (continuous glucose monitor) has been shown to reduce hyperglycemia. Without CGM, this patient is at risk of ongoing hyperglycemia which would increase his risk for retinopathy, neuropathy, and nephropathy. Also, the American Diabetes Association clinical guidelines support the need for glucose testing for the management of type 2 diabetes due to the risk of hypoglycemia and hyperglycemia, which can be life-threatening. This patient is unable to perform fingerstick monitoring due to painful neuropathy. This is of particular concern in his case given his history of hypoglycemic episodes. He is limited to the use of continuous glucose monitoring to monitor glucose as fingerstick glucose monitoring is not an option for him. Therefore, the requested durable medical equipment (continuous glucose monitor A9278, A8277, and A9276) is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Central Nervous System
Inpatient hospital

Diagnosis: Cerebral Palsy
Treatment: Acute inpatient rehab
The insurer denied the acute inpatient rehab stay. The health plan's determination is upheld. 

The patient is a male who has diagnosis of spastic cerebral palsy, status/post (s/p) bilateral distal femoral extension osteotomy and bilateral patellar tendon advancements. Available records include a letter that details the physical therapy (PT) goals and occupational therapy (OT) goals and expected activities to be undertaken in therapy. Also available is a letter from the provider which expresses the opinion that the patient is physically capable of performing 3 hours of physical therapy a day (15 hours per week) and that home therapy would not be safe. It documents that the patient has been unable to stand or be placed in a gait trainer for a couple of years. Also available are records from the hospitalization for the surgery. According to hospital records, the patient is non-ambulatory at baseline and dependent in activities of daily living (ADL) s. There is documentation that he has quadriplegia in the orthopedic history and physical exam.

At the current time, inpatient acute rehabilitation stay is not medically necessary to achieve important health and functional goals, and a less intensive setting would be appropriate. The patient does not require frequent physician visits, inpatient care of rehabilitation nursing, and acute inpatient rehabilitation program. The documentation does not include goals that can reasonably be expected to be only achieved during an acute inpatient stay. The clinical documentation and standards of care support that the patient can be treated at a lower level such as a sub-acute rehabilitation facility to receive care for his short term goals. His long term goals can then be appropriately continued as an outpatient. The patient has a good prognosis for benefiting from subacute rehabilitation program and returning to his home in the community which would be the standard of care for a case such as this.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Acute Lymphoblastic Leukemia
Treatment: Prevymis 480 mg
The insurer denied Prevymis 480 mg. 
The determination is overturned.

This is a patient with Philadelphia-positive (Ph+) acute lymphoblastic leukemia. She underwent an allogeneic stem cell transplant; the donor and recipient were cytomegalovirus (CMV) positive. Formulary alternatives are Valacyclovir, Valganciclovir tablets or Ganciclovir intravenous solution. Letermovir (Prevymis) has been recommended and is under review for medical necessity.

This patient is at high risk for CMV disease. The authors of UpToDate state "... in high-risk patients, we would favor letermovir over other agents. Letermovir (480 milligrams (mg) orally or intravenous (IV) once daily or, in patients taking cyclosporine, 240 milligrams (mg) once daily) should be initiated after hematopoietic cell transplantation (HCT) and continued through week 14. Letermovir is active against CMV but does not have activity against herpes simplex virus (HSV) or varicella-zoster virus (VZV); thus, clinicians will need to provide prophylaxis against these viruses when indicated....'". As the provider noted in the letter of medical necessity, letermovir is Food and Drug Administration (FDA) approved for this clinical scenario (i.e. post-transplant CMV prophylaxis in adult CMV-seropositive allogeneic stem cell transplant recipients. All-cause mortality at weeks 24 and 48 following transplant was lower in patients receiving letermovir when this was evaluated in a phase III trial - this was particularly pronounced in high risk patients such as this. For various reasons, the survival advantage associated with letermovir has not been demonstrated to be present in patients with gancyclovir, valacyclovir, or valganciclovir; this may be due to increased neutropenia and secondary bacterial and fungal infections.
This approach is supported in the peer-reviewed literature and for these reasons, medical necessity has been established.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Endocrine/Metabolic/Nutritional-Diabetes
Treatment: Diabetic Equipment, Supplies and self Management Education-Continuous glucose monitor and all associated supplies
The health plan denied the Continuous glucose monitor and all associated supplies as not medically necessary. 
The reviewer has overturned in whole the health plan's determination.

This is a patient with uncontrolled type 2 diabetes treated with glipizide and Januvia. Due to the patient's  disability and cognitive impairment, the patient has great difficulty using a traditional glucometer. The A1C 8.1%. The documented goal A1C for the patient is 7.0% according to the records provided for review.

This patient has uncontrolled type 2 diabetes. Glucose monitoring is necessary in this clinical situation as supported by the American Diabetes Association due to risk of hyperglycemia and hypoglycemia. This patient is at particular risk of hyperglycemia given her elevated A1C and hypoglycemia as she is on a sulfonylurea. This patient is unable to reliably use a standard glucometer due to her cognitive impairment. The Freestyle Libre 14 day sensor is significantly easier to use as it does not require a fingerstick or application of blood to a test strip. Therefore, the requested continuous glucose monitoring and all associated supplies are medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Chronic obstructive pulmonary disease  (COPD).
Treatment:  Personal Care Services.

The insurer denied Increase in Personal Care Services (24 Hours per Day, 7 Days per Week).  The health plan's determination is overturned. 

The patient is a female with a past medical history of chronic obstructive pulmonary disease (COPD), breast cancer, hypothyroidism, osteoarthritis, urinary incontinence, and recent right hip fracture, who had been previously assigned personal care assistant (PCA) services 6 hours/day, 7 days/week to total 42 hours/week.  The patient had a fall when unattended with resultant right hip fracture requiring hospitalization and subsequent rehabilitation stay.  The occupational therapy (OT) summary of care stated the patient was contact guard assistance with the tasks of toileting, toilet and commode transfers, and bed mobility while noted to need minimum assist with dressing lower body.  The discharge assessment by OT also noted the patient to require set up help with hygiene and grooming and supervision with dressing upper body.

The Increase in Personal Care Services: 24 Hours per Day, 7 Days per Week is medically necessary.

The patient had a documented change in functional status following a fall with right hip fracture.  The patient required help with all ADLs and Instrumental activities of daily living (IADLs) except eating.  The patient's occupational and physical therapy notes from the discharge from rehabilitation indicated the patient needed some assistance with toileting, toilet and commode transfer, bed mobility, dressing, ambulation, and transfers.  The patient's orthopedic provider and PCP (primary care physician) indicated the patient needed assistance with ADLs 24 hours/day.  The patient has unscheduled and unpredictable care needs over a particular span of time, which the plan did not take into account. The patient requires assistance with these unscheduled and unpredictable care needs including, but not limited to, locomotion, walking, toileting, transfer toilet, and bed mobility.  The patient's additional hours are not for safety, supervision or companionship but to assist the patient with safe completion of her ADLs and IADLs.  The patient's care needs span 24 hours per day; therefore, the plan should not have utilized the task based assessment tool.  The son documents that he and his wife are not able to provide the amount of assistance to meet the patient's care needs, and she therefore does not have informal support outside of the assigned PCA hours.  Personal care services are medically necessary when assistance with nutritional and environmental support function is essential to the maintenance of the patient's health and safety in her own home.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Acute myeloid leukemia.
Treatment:  Formulary Exception for Sandimmune Solution

The insurer denied coverage for Formulary Exception for Sandimmune Solution.  The denial is upheld. 

This is a male patient with a history of Acute Myeloid Leukemia (AML), who underwent an allogenic peripheral blood stem cell transplant at the hospital.  Post-transplant, it is necessary for the patient to be immune suppressed to prevent graft versus host disease.  The physician is using Sandimmune.  The patient was maintained on Sandimmune throughout his hospital stay.  Cyclosporine has a narrow therapeutic range.  Small variations in therapeutic range may have serious consequences for patients post-transplant. 

The formulary drugs are not likely to cause the patient an adverse reaction when managed correctly.  While the formulary drugs are also cyclosporine, they are not all bioequivalent due to varying absorption.  "Sandimmune capsules and oral solution have decreased bioavailability in comparison with Gengraf and Neoral capsules and Gengraf and Neoral oral solution. Gengraf and Neoral have increased bioavailability compared to Sandimmune capsules and oral solution and are not bioequivalent to Sandimmune and cannot be used interchangeably without the supervision of a health care provider" (Lexicomp).  Therefore, if measured appropriately, the selection of which cyclosporine would not cause the patient an adverse event and the appropriate step is to try cyclosporine - as available in the formulary first - and not Sandimmune.  The patient has not tried the formulary drugs.  The requested drug would not be more effective than the formulary drug if managed correctly.

"Cyclosporine is one of the most vital agents in the process of successful allogeneic hematopoietic stem cell transplantation.  Despite a long history and worldwide extent of cyclosporine use for prevention of graft versus host disease, currently there are lots of uncertainties about its optimal method of application to reach the best clinical outcome.  A major portion of this problem stems from complicated cyclosporine pharmacokinetics.  Study of cyclosporine pharmacokinetic behavior can significantly help recognition of its effectiveness and consequently, optimization of dosing, administration, monitoring and management of adverse effects.  In this review, highly accredited but sparse scientific data are gathered in order to provide a better insight for preparation of practice guidelines and directing future studies for allogeneic hematopoietic cell recipients" (Tafazoli, A.).

Based on the above, denial of Formulary Exception for Sandimmune Solution is upheld.