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

Diagnosis: Pulmonary Embolism. 
Treatment: Inpatient Admission. 

The insurer denied coverage for inpatient admission. 

The denial is upheld. 
 
The patient is an adult who was sent to the Emergency Department (ED) for treatment of pulmonary embolism (PE). The patient reported some exertional shortness of breath. The patient has a history of Lung Cancer Stage II. The patient underwent a Computed Tomography (CT) of the Chest and Abdomen for staging. The patient was found to have an incidental finding of pulmonary embolism (PE). The patient denied any chest pain (CP) or palpitations. 

At presentation vitals included temperature 98.8 degrees Fahrenheit, respiratory rate 22, heart rate 102, blood pressure 146/70, oxygen saturations 95 % on room air. The patient was in no acute distress, lungs were clear, heart sounds normal, abdomen soft, no edema, alert and oriented to person, place and time, non-focal neurological exam. The patient was admitted to the hospital for a pulmonary emboli (PE). The patient was initially started on intravenous (IV) Heparin for a brief period and then switched to oral Apixaban. White blood cell count was 4.8, hemoglobin 11.7, Computed tomography (CT) of the chest did not show right heart strain. Deep vein thrombosis (DVT) study was negative, echocardiogram with normal right ventricle function. There was no pulmonary hypertension. The patient remained stable after admission. The patient was discharged home on oral anticoagulation (AC) the next day. 

This patient did not need acute inpatient hospital stay. The patient was stable to be placed on Observation level of care while treatment was ongoing for further diagnostic testing. The patient was afebrile and hemodynamically stable. The patient was not hypoxic. There was no evidence of right heart strain. Deep vein thrombosis (DVT) study was negative. The patient was on oral anticoagulants (AC). Finding of the pulmonary emboli (PE) was incidental on a staging computed tomography (CT). The patient could have been discharged home on oral AC after a period in Observation without acute inpatient admission and with close follow up in the outpatient setting. Observation could be for up to 48 hours. 

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 hospital stay is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Malocclusion
Treatment: Braces
The insurer denied Braces.
The denial is overturned.

The patient is an adolescent female. The request is for braces. She has a Class I malocclusion. She has moderate upper and lower arch crowding. She has severe overjet with incompetent lips. The health plan's prior denial of coverage was due to a score of 19 on the handicapping scale. The denial is being appealed.

The braces are medically necessary.

The patient has a severe overjet of more than 9mm (millimeters) with incompetent lips. Due to her upper front teeth being so far forward, she has to force her lips closed at rest. When there is an overjet of more than 9mm (millimeters) with incompetent lips, this is an automatic qualifier according to the handicapping index scale. The case has medical necessity, and orthodontic treatment is needed to correct the malocclusion.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hidradenitis Suppurativa. 
Treatment: Skyrizi Pen. 

The insurer denied coverage for Skyrizi Pen. 

The denial is overturned. 

The patient is an adult female with a diagnosis of hidradenitis suppurativa (HS) who has failed therapy with oral antibiotics, intralesional Kenalog injections, Humira, topical steroids, Metformin, Spironolactone, Ozempic, Doxycycline orally. The requested medication is Skyrizi. 
 
Skyrizi is medically necessary for the patient's condition, hidradenitis suppurativa (HS). The patient has failed Humira, which is a Food and Drug Administration (FDA) approved medication indicated and approved for the treatment of HS. In addition, the patient has failed numerous systemic agents known to treat hidradenitis suppurativa. Case reports have demonstrated efficacy of Skyrizi for the treatment of hidradenitis suppurativa. The standard of care for failure of medications known to treat HS has been met based on the reported history. As such, the use of an alternative treatment strategy in the form of Skyrizi is approved. 

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 Pen is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Sickle Cell Anemia.

Treatment: Siklos 1000 MG OR TABS.

The insurer denied coverage for Siklos 1000 MG OR TABS.

The denial is upheld.
 

The medical records indicate the patient has a diagnosis of Sickle Cell Anemia and has been stable while being treated with Hydroxyurea. The patient complains of occasional pain, in his back, that is relieved with the use of Oxycodone and Tylenol. He is currently stable, able to participate in extracurricular activities and is drinking Ensure to keep his weight at an appropriate level.

At this time, the provider is requesting approval for treatment using Siklos which is the topic of this review.

The patient has a diagnosis of Sickle Cell Anemia and is currently stable on a compounded form of hydroxyurea with good pain control and no adverse effects. There are no data or medical literature that shows Siklos-which is a brand name for hydroxyurea- is superior to hydroxyurea in terms of efficacy or in reduced side effects. The note indicates the plan to switch to Siklos but does not make clear what the rationale for the change beyond "compliance" which does not seem to be an issue based on the patient's clinical response. Therefore, it is not necessary to change the patient's treatment plan from hydroxyurea to Siklos. 

"Hydroxyurea lowers the incidence of vaso-occlusive pain crises (VOC) and acute chest syndrome (ACS) among children with sickle cell anemia (SCA)." (Reeves, S. L., 2023).

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 Siklos 1000 MG (milligram) OR TABS (oral tablets) is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: heart failure, arthritis, anxiety and depression

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

The insurer denied coverage for personal care worker (PCW) services to 7 days per week, 24 hours per day, continuous care by more than one person; 168 hours per week

The denial is upheld
 

This is an advanced elderly patient with chronic medical problems including heart failure, arthritis, anxiety and depression.  She lives with her husband in a private residence.  The insurer approved personal care worker (PCW) services live-in (91 hours/week).  The patient is seeking an increase to split-shift services.   

The Uniform Assessment System (UAS) report was reviewed.  The patient's cognitive skills are described as moderately impaired.  She is reportedly totally dependent for much of her Instrumental Activities of Daily Living (IADL) tasks including meal preparation, ordinary housework and shopping.  Extensive assistance is reportedly needed for bathing, personal hygiene, dressing, locomotion, ambulation (uses a walker) and toilet transfer/use.  Limited assistance is reportedly needed for bed mobility and eating.  She is frequently incontinent of bladder and infrequently incontinent of bowel.  

The patient's medical condition, cognitive deficits and physical limitations are not at the level or unpredictable as to require the requested personal care worker (PCW) services to 7 days per week, 24 hours per day, continuous care by more than one person; 168 hours per week.   According to her treating physician in a letter, the patient "is a strong risk for wandering from home and possibly turning on the kitchen stove and not turning it off."  He also notes the patient "is at risk for falls due to mobility issues, decreased muscle strength and arthritis of her hips and knees."  

This physician would agree that given the patient's reported cognitive deficits, general weakness and propensity for wandering, she may benefit from additional safety monitoring.  However, safety monitoring under personal care services (PCS) does not include monitoring an individual when no other Level I or Level II personal care services task is being provided.  Based on the records reviewed, a live-in personal care worker (PCW) is likely capable of providing for the patient's functional needs with the ability to consistently obtain uninterrupted 5 hours of sleep.  The patient's functional needs are appropriately provided and maintained with the currently approved live-in PCW services.  

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 an increase in personal care worker (PCW) services to 7 days per week, 24 hours per day, continuous care by more than one person; 168 hours per week services is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dementia
Treatment: Personal Care Assistance Services 24 Hours per Day 7 Days per Week (split shift)
The plan denied the Personal Care Assistance Services 24 Hours per Day 7 Days per Week (split shift).
The denial is overturned.

The patient is an elderly male. His medical conditions include dementia, hypertension, peripheral neuropathy, and spinal stenosis with lower extremity weakness. Denial of personal care assistance services 24 hours per day 7 days per week (split shift) is being appealed. The health plan approved 84 hours per week.

Uniform Assessment System (UAS) evaluation completed a few months prior shows severely impaired cognition and functional status: total dependence with meal preparation, housework, managing finances, phone use, shopping, transportation, bathing personal hygiene, dressing, and eating; and maximal assistance with managing medications and bed mobility. The patient is bedbound. He has bowel and bladder incontinence and requires frequent diaper changes.

An appeal letter notes that the patient lives with his wife, and they are completely dependent for ADLs (activities of daily living). His health has deteriorated. He was admitted in last Autumn with delirium and inability to walk. He had two admissions in a few months ago with heart disease. Since discharge, he is confused, has increased drowsiness, and he can no longer stand. He is in hospice care.

This patient has multiple chronic conditions. Uniform Assessment System (UAS) evaluation completed a few months prior showed the patient is bedbound and requires maximal assistance to total dependence with all ADLs (activities of daily living). He is incontinent of bowel and bladder. The appeal statement indicates the patient's health has deteriorated. The statement supports the patient is dependent with all ADLs (activities of daily living) and requires frequent assistance with toileting. This patient's functional impairments support that the patient has continuous needs that will not give the aide five hours daily of uninterrupted sleep during the aide's shift. The requested increase of personal care assistance services to 24 hours per day 7 days per week (split shift) is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate cancer.
	
Treatment: Proton Beam Therapy.

The insurer denied coverage for Proton Beam Therapy.

The denial is upheld.

This case involves an adult male seeking proton beam therapy. The patient underwent prior biopsy of the prostate that revealed cancer/adenocarcinoma.  Review of prior magnetic resonance imaging (MRI) revealed posterior extracapsular extension.  It was noted the patient was trying to decide between prostatectomy, Stereotactic Body Radiation Therapy (SBRT), and proton beam radiotherapy.  Treatment options were discussed, and the patient was noted to be an excellent candidate for proton beam radiotherapy.  It was noted that proton team therapy would reduce the amount of excessive radiation delivered to the organs surrounding the prostate and reduce risks of several adverse effects.  Appeal letter reported the patient was being recommended for proton beam therapy for high-risk prostate cancer.  It was noted that case match plan shows superiority of proton versus Intensity-modulated Radiation Therapy (IMRT) to include exposure to the bladder and small bowel.  Determination letter reported prior denial was upheld since proton beam therapy remains investigational for the treatment of prostate cancer per National Comprehensive Cancer Network (NCCN) and Astro Model Policy.

NCCN states there is no clear evidence to support a benefit or decrement to proton therapy over IMRT for either treatment efficacy or long-term toxicity. The use of proton beam therapy is not supported/required in this case. The patient's prostate cancer can be treated with other forms of radiation therapy. As such, Proton Beam Therapy is not considered medically necessary for this patient.

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient.

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 Proton Beam Therapy is not substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Rheumatoid arthritis.
Treatment:  Actemra.

The Health Plan denied Actemra.  The health plan's determination is overturned in whole.

The patient is a female with rheumatoid factor (RF) negative, rheumatoid arthritis (RA) and recent breast cancer (diagnosis 2021, status/post mastectomy, radiation and chemo, currently on exemestane (an anti-cancer hormone therapy)). Prior treatment includes oral Methotrexate (MTX). She is currently on injectable MTX and Prednisone 5 milligrams (mg) daily and still has active disease. The issue in this case is Actemra is being denied by the health plan. The reason for denial is the patient has not tried the formulary drugs. Given recent history of malignancy and treatment with Exemestane, her provider would like to avoid tumor necrosis factor (TNF) inhibitors and Janus Kinase Inhibitors (JAK) inhibitors. The patient's provider has coordinated care with the patient's oncologist as well as agrees that Interleukin-6 (IL-6) inhibition would be most appropriate in this case.

Formulary medications for the treatment of RA per the health plan's policy are Enbrel, Humira, Rinvoq, and Xeljanz. The decision to start a biologic in a patient with a history of cancer is somewhat uncertain. As published in Ann Rheum Dis in 2015, 'among patients with RA and a history of breast cancer, those who started TNFi-treatment did not experience more breast cancer recurrences than patients with RA treated otherwise. The general advisability of our findings to women with a very recent or a poor prognosis of breast cancer remains unknown'. In terms of JAK inhibitors, a study published in 2023 concluded that 'we did not find any difference in the cancer risk between Tofacitinib and either the placebo or biological drugs overall. In contrast, we found only a slightly higher risk of cancer in patients treated with Tofacitinib compared with the patients treated with drugs that inhibit the tumor necrosis factor. Therefore, further studies are needed to better define the cancer risk of Tofacitinib therapy (Cancers 2023).' Given these findings, the formulary medications would not be appropriate to treat the patient's RA given her 2021 breast cancer diagnosis. The patient's provider is requesting a trial of Actemra, as there is data showing that malignancy rates are stable with long-term Tocilizumab treatment, and malignancy types and rates were consistent with those expected in patients with RA (RMD Open 2016).

The formulary drugs would be inappropriate, given very recent breast CA diagnosis as outlined above. A trial of Actemra would be a reasonable next step in this case, given very recent diagnosis of breast cancer and Actemra is compatible with Exemestane, which the patient is currently on for treatment of breast cancer.
Appeal type: Formulary Exception
Decision: Overturned

The patient is a woman with rheumatoid factor (RF) negative, rheumatoid arthritis (RA) and recent breast cancer (diagnosis 2021, status/post mastectomy, radiation and chemo, currently on exemestane (an anti-cancer hormone therapy)). Prior treatment includes oral Methotrexate (MTX). She is currently on injectable MTX and Prednisone 5 milligrams (mg) daily and still has active disease. The issue in this case is Actemra is being denied by the health plan. The reason for denial is the patient has not tried the formulary drugs. Given recent history of malignancy and treatment with Exemestane, her provider would like to avoid tumor necrosis factor (TNF) inhibitors and Janus Kinase Inhibitors (JAK) inhibitors. The patient's provider has coordinated care with the patient's oncologist as well as agrees that Interleukin-6 (IL-6) inhibition would be most appropriate in this case.

I overturn, in whole the health plan's determination.

Formulary medications for the treatment of RA per the health plan's policy are Enbrel, Humira, Rinvoq, and Xeljanz. The decision to start a biologic in a patient with a history of cancer is somewhat uncertain. As published in Ann Rheum Dis in 2015, 'among patients with RA and a history of breast cancer, those who started TNFi-treatment did not experience more breast cancer recurrences than patients with RA treated otherwise. The general advisability of our findings to women with a very recent or a poor prognosis of breast cancer remains unknown'. In terms of JAK inhibitors, a study published in 2023 concluded that 'we did not find any difference in the cancer risk between Tofacitinib and either the placebo or biological drugs overall. In contrast, we found only a slightly higher risk of cancer in patients treated with Tofacitinib compared with the patients treated with drugs that inhibit the tumor necrosis factor. Therefore, further studies are needed to better define the cancer risk of Tofacitinib therapy (Cancers 2023).' Given these findings, the formulary medications would not be appropriate to treat the patient's RA given her 2021 breast cancer diagnosis. The patient's provider is requesting a trial of Actemra as there is data showing that malignancy rates are stable with long-term Tocilizumab treatment, and malignancy types and rates were consistent with those expected in patients with RA (RMD Open 2016).
The formulary drugs would be inappropriate, given very recent breast CA diagnosis as outlined above. A trial of Actemra would be a reasonable next step in this case, given very recent diagnosis of breast cancer and Actemra is compatible with Exemestane, which the patient is currently on for treatment of breast cancer.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ulcerative Colitis
Treatment: Rinvoq tablets 45 milligrams (mg) extended release (ER) (Take 45 mg daily for 8 weeks followed by 30 mg daily thereafter)
The insurer denied the Rinvoq tablets 45 mg ER (Take 45 mg daily for 8 weeks followed by 30 mg daily thereafter).
The health plan's determination is upheld.

The patient is a male with severe ulcerative colitis and celiac disease. He has failed corticosteroids, 5-aminosalicylates, Entyvio, and high-dose Stelara (every 4 weeks). He has had diarrhea, hematochezia, and a recent flare with diarrhea and hematochezia. The colonoscopy showed ileal erythema, scarring through most of the colon, congestion and erythema from hepatic flexure to rectum. The coverage is requested for Rinvoq (45 mg daily for 8 weeks and then 30 mg daily) for the treatment of ulcerative colitis. The request was not approved as an anti-tumor necrosis factor medication has not been attempted.

The health plan, in its determination of medical necessity, did act reasonably, with sound medical judgment and in the best interest of the patient.

No, the request for Rinvoq is not medically necessary and is not supported based on the submitted documentation in the case. The American Gastroenterological Association and American College of Gastroenterology guidelines for the treatment of Ulcerative Colitis recommend anti-tumor necrosis factor (anti-TNF) medications for the treatment of Ulcerative Colitis [1,2]. Rinvoq is approved by the U.S. Food and Drug Administration (FDA) for the treatment of Ulcerative Colitis [3,4]. That approval specifically states that Rinvoq is approved for use in "Adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers", which is not documented in this case. Rinvoq has warnings regarding potentially severe adverse events, including cardiovascular events and sudden cardiovascular death, cancer, and thrombosis; no medical reason to avoid an attempt of anti-TNF medications is documented in this case. For these reasons, the submitted documentation does not support the use of Rinvoq in this case.

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