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

Diagnosis: Crohn's disease.
Treatment: Pentasa.
The insurer denied the Pentasa.
The determination is overturned.


This is a patient with a history of Crohn's disease. Pentasa is under review for medical necessity.

Pentasa is Food and Drug Administration (FDA) approved for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis. Despite the lack of FDA approval in Crohn's disease, the clinical practice guidelines do support the use of mesalamine products (such as Pentasa) in treating mild Crohn's disease with small bowel and colonic inflammation.
Per the guidelines "5- aminosalicylic acid (ASA) might be used for induction of remission in children with mild colonic inflammation" (Ruemmele FM et al).
According to Hanauer, Stephen B:"The meta-analysis of 3 large, double-blind, randomized studies in the treatment of active Crohn's disease confirms that Pentasa 4 grams (g)/day is superior to placebo in reducing the Crohn's disease activity index (CDAI)."
Per Coward, Stephanie, et al: "High-dose mesalamine is an option among patients preferring to avoid steroids."
This child has proximal small bowel and colonic disease. Therefore, the use of Pentasa in this case is appropriate.
The available formulary alternatives are intended for colonic disease only and have no small bowel release. Pentasa is the only mesalamine formulation that has small bowel release, making it superior in this case with duodenal and ileal Crohn's disease.
Therefore, the requested Pentasa is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Left breast cancer.
Treatment: Proton beam therapy.
The insurer denied Proton beam therapy. 
The health plan's determination is overturned.

The patient is a female with a history of left breast cancer status post (s/p) neoadjuvant systemic therapy followed by surgical resection (simple mastectomy, Sentinel Lymph Node Biopsy (SLNbx) and a tissue expander based reconstruction). It has been recommended for the patient to proceed with a course of postoperative external beam radiotherapy with a curative intent. 

The requested proton beam radiotherapy is medically necessary and standard of care for this patient. The treating provider supplied a proton/photon plan comparison which reveals that the photon-based plan is unable to provide adequate safety/precision. The proton radiation plan was able to significantly reduce the heart/lung exposure to within known safe tolerance limits, thereby minimizing the patient's risk for high grade toxicity. Proton radiation is supported by the American Society for Radiation Oncology (ASTRO) Model Policy in the patient's situation as the provider has shown that photon radiation cannot meet nationally accepted treatment planning objectives with regard to normal tissue avoidance. There are numerous high quality prospective clinical outcomes published in the medical literature which support the safety/efficacy of proton radiation for management of node positive left breast cancer.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Ovarian cancer with metastasis to the liver and bilateral pleural effusion.
Treatment: PCA (patient care assistant) level 2: 12 hours per day- 7 days per week; 12 hours per day- 7 days per week (split-shift) for a total of 168 hours per week.
The insurer denied coverage for PCA (patient care assistant) level 2: 12 hours per day- 7 days per week; 12 hours per day- 7 days per week (split-shift) for a total of 168 hours per week.
The denial is overturned.

The patient is an elderly female requesting home care services.  She has a history of ovarian cancer with metastasis to the liver and bilateral pleural effusion.  The doctor writes that the patient has had rapid deterioration with functional and nutritional decline. The patient is bedbound, totally dependent on others for all activities of daily living (ADL's), requires repositioning in bed every 2 hours to prevent pressure ulcers, and needs to be spoon-fed to eat. The patient is bedbound, totally dependent on others for all ADL's (activities of daily living) and requires repositioning in bed every two hours to prevent pressure ulcers, and needs to be spoon-fed to eat. The requested services, PCA (patient care assistant) level 2: (12 hours per day- 7 days per week; 12 hours per day- 7 days per week (split-shift) for a total of 168 hours per week) are considered medically necessary for this patient. 

Landers, et al., (2016), "America is experiencing a dramatic shift in demographics, and in 2019, people older at geriatric age will outnumber those younger than five. As Americans age and live longer, increasing numbers of them will live with multiple chronic conditions, such as diabetes or dementia, and functional impairments, such as difficulty with the basics of life like mobility and managing one's household. One of the greatest healthcare challenges facing our country is ensuring that older Americans with serious chronic illnesses and other maladies of aging can remain as independent as possible. Our success with this challenge will help ensure that Americans age with dignity in a manner that meets their expectations, preferences, and care needs."                                                         

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 PCA (patient care assistant) Level 2: 12 hours per day- 7 days per week; 12 hours per day- 7 days per week (split-shift) for a total of 168 hours per week services is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Irritable bowel syndrome and rheumatoid arthritis with a positive rheumatoid factor
Treatment: Rasuvo
The insurer denied coverage for Rasuvo
The denial is overturned

This patient has irritable bowel syndrome and rheumatoid arthritis with a positive rheumatoid factor. She had been on oral methotrexate for a year. Because she has both irritable bowel syndrome and rheumatoid arthritis the methotrexate was switched from oral to subcutaneous to obtain better bioavailability. She has difficulty drawing up the medication from the vial as such an autoinjector Rasuvo medication was requested.

The provider wanted to increase bioavailability of the medication by switching from oral to subcutaneous methotrexate. The subcutaneous methotrexate is available in a generic form whereby the patient had to draw up the medication into a syringe.  The provider documented that this particular individual is not able to do that and the Rasuvo autoinjector is medically necessary in this case.      

"Methotrexate is an Food and Drug Administration (FDA)-approved folic acid antagonist indicated for the treatment of rheumatoid arthritis because of its high potency and efficacy in such patients; it can also be useful in patients with juvenile idiopathic arthritis.[1] Gubner first suggested methotrexate use in rheumatoid arthritis after performing a double blinded-placebo controlled clinical trial of methotrexate in patients with rheumatoid arthritis.[2] Aminopterin was originally considered the parent compound for the methotrexate was first used successfully to treat childhood leukemia." (Hannoodee, M. et al. 2021).

"Methotrexate (MTX) is still considered the drug of choice in rheumatoid arthritis (RA) management. Comparing subcutaneous (MTX SC) and oral (MTX OR) routes of administration is important to optimize the everyday therapeutic strategy in the real-life setting.." (Bianchi, A.E. et al., 2016).                                                         

Based on the above, the insurer's denial must be reversed. 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 Rasuvo services is substantiated.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis:  Glaucoma, Arthritis and Dementia.
Treatment:  Consumer Direct Personal Assistance program (CDPAP): live in per diem: 7 days per week.
The insurer denied coverage for CDPAP: live in per diem: 7 days per week. 
The denial is modified.

This is a very elderly woman with chronic medical problems including glaucoma, arthritis and dementia.  She lives with her daughter and son-in-law.  The insurer approved CDPAP: 8 hours per day - 7 days per week - for a total of 56 hours per week.  The request is an increased CDPAP to 24 hours/day (live in).

The Uniform Assessment System (UAS) report.  The patient's cognition is described as "Moderately impaired."  She requires maximal assistance for bathing, lower body dressing and toilet use.  Extensive assistance is needed for personal hygiene, upper body dressing, ambulation (with a walker), bed mobility and toilet transfer.  She is occasionally bladder incontinent and continent of bowel.  Limited assistance is needed for eating.  Her cognitive status has declined when compared to the UAS and her functional ability is much the same.  The patient's condition and functional needs are not at a level or unpredictable as to require the requested increased CDPAP to 24 hours/day (live in).  However, it is sufficient to support increasing CDPAP to 12 hours/day.  This physician would also agree the patient may require additional monitoring.  However, safety monitoring under personal care services (PCS) does not include monitoring an individual (e.g., with dementia) 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 can be appropriately provided and maintained by the increasing CDPAP to 12 hours/day.  

From a physical medicine and rehabilitation perspective, the requested CDPAP: live in per Diem: 7 days/week is not medically necessary.   However, increasing CDPAP to 12 hours/day, 7 days/week, for total of 84 hours/week is medically necessary.

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 consumer direct personal assistance program (CDPAP): live in per diem: 7 days per week services is not substantiated. Increasing CDPAP to 12 hours/day, 7 days/week, for total of 84 hours/week is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Diabetes
Treatment: Continued stay at a skilled nursing facility (SNF)
The insurer denied coverage for continued stay at a skilled nursing facility
 The denial is upheld

This is a male with multiple medical problems including hypertension, diabetes, seizures and peripheral vascular disease. He was transferred from the hospital to a skilled nursing for subacute rehabilitation and wound care services. Under review is the medical necessity for continued stay at a skilled nursing facility.

The admission was initially appropriate for the SNF subacute rehabilitation level of care (1, 2, 3). His clinical condition and functional deficits were amenable to medical intervention and comprehensive rehabilitation. He participated in physical and occupational therapy with demonstrated gradual improvement.  Occupational therapy notes indicate the patient required minimal to stand by assistance for much of his activities of daily living. Wheelchair mobility required only stand by assistance. According to the physical therapy notes submitted for review, therapy was discontinued. The reviewer was at the supervision to contact guard assistance for transfers and short distance ambulation. In addition, there were no acute medical or complicated nursing issues (wound care was routine) that required continued stay at the SNF for the time period under review.  

The healthcare plan acted reasonably, with sound medical judgment and in the best interest of the patient.  

From a physical medicine and rehabilitation perspective, as well as within a reasonable degree of medical certainty, continued stay at a skilled nursing facility was not medically necessary.

The insurer's denial of coverage for continued stay to a skilled nursing facility is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Thrombocytopenia.

Treatment is an inpatient admission .

The insurer denied coverage for an inpatient admission. 
 
The denial is overturned.

This case involves a patient diagnosed with systemic lupus erythematosus (SLE), immune thrombocytopenic purpura, Sjogren's disease, rheumatoid arthritis, and connective tissue disease who presented to the emergency room complaining of worsening thrombocytopenia. The records provided for the review noted that when the patient presented her vital signs were stable. The patient reported having suffered a nosebleed 2 days prior and subsequently underwent laboratory testing which noted low platelets. She had received IVIG (Intravenous Immunoglobulin) infusion and reported bruising on her hands, but denied shortness of breath, chills, fever, or chest pain. The report stated that the patient's platelets were 10. It was determined that she would likely require additional platelets despite a recent platelet transfusion.  She was apprehensive about being admitted to the hospital and was overall well-appearing with consideration for sending her home. Initially, the patient was advised to increase her prednisone dosing and come to the hospital for evaluation. She reported feeling well and presented with a history of thrombocytopenia with no active bleeding at that time. The patient was subsequently admitted for further treatment and discharged the following day. The inpatient stay was initially denied with claims that she was not found to have 0 problems warranting a full hospital admission. The patient was admitted to the hospital with worsening thrombocytopenic purpura. The claims were that she met the Milliman Care Guidelines 25th edition criteria using the guidelines of hematology GRG: MG-HCM.  

The Milliman Care Guidelines 26th edition states that hospital admission is needed when a patient has severe life-threatening bleeding with any reduced platelet count, platelet count less than 20,000/mm3 (Cubic Millimeters) with any active bleeding, platelet count less than 10,000/mm3 with LidoPro or petechiae, platelet count less than 5000/mm3, or low platelet count with hemolytic anemia.  Records confirmed that the patient had a platelet count of 15, which had dropped from 25 (despite administration of steroids) indicating thrombocytopenia. Given the patient's recent episode of epistaxis and history of systemic lupus erythematosus and immune thrombocytopenic purpura with Sjogren's disease, it was determined that although the patient was otherwise showing normal vital signs, the continued reduction in platelet count was a red flag and required treatment. The overnight stay and associated treatment was justified. As such, the full hospital admission was medically necessary.

The healthcare plan did not act reasonably and was on medical judgment and in the best interest of the patient.

The insurer's denial of coverage for full hospital admission is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Osteoarthritis
Treatment is an inpatient admission 
The insurer denied coverage for an inpatient admission 
The denial is upheld.

This is a patient with a history of diabetes, hepatic steatosis, hypertension, sleep apnea, osteoarthritis (OA), and a pulmonary nodule. He presented to the hospital for a scheduled left knee replacement. The procedure was performed without complications. The patient was given standard postoperative and intraoperative antibiotics. His pain was well controlled on oral (PO) medications and the patient was able to tolerate a regular diet. The hospital course was uneventful, and the patient was discharged. 

The medical record showed a non-complicated post-surgical course. The patient's vital signs were stable. There was no evidence of fever. He had no signs of bleeding. He was able to progress with PT (physical therapy) services. He did not require additional imaging nor management of other medical conditions. He was able to tolerate oral pain medications. He was evaluated by Pain Management, the consultant provided a protocol and signed off. The Orthopedic progress notes describes his pain is tolerated and gave recommendations for discharge when he was cleared. If additional pain was present, a prescription of Tylenol was recommended. These records were not consistent for a person with intractable pain. Changes in oral regimen would be just as likely appropriate. There were no additional nor special services provided to substantiate the length of stay.

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for a full hospital admission is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriasis vulgaris; psoriatic arthritis
Treatment: Tremfya 100 MG/ML (milligrams per milliliter) SC (subcutaneous) SOPN (Solution Pen-Injector)
The insurer denied: Tremfya 100 MG/ML (milligrams per milliliter) SC (subcutaneous) SOPN (Solution Pen-Injector)
The denial is overturned.

The patient is an adult male with severe psoriasis vulgaris and psoriatic arthritis. He has tried and failed Otezla, fluconazole, clobetasol, ketoconazole, and fluocinonide. This is a request for Tremfya. The patient has asymptomatic HIV (Human Immunodeficiency Virus) infection with neuropathy, possible inflammatory bowel disease (IBD), and a family history of Crohn's disease.

The requested Tremfya is medically necessary.
The patient has severe psoriasis and psoriatic arthritis refractory to multiple oral and topical therapies, as listed above. Due to his medical history of HIV (Human Immunodeficiency Virus), neuropathy, possible IBD (inflammatory bowel disease), and family history of Crohn's disease, Tremfya is currently the safest option for his disease. Also, Tremfya has proven to be more effective in the treatment of psoriasis than the health plan's preferred alternatives.

Two phase 3, multicenter, randomized, double-blind, placebo and active comparator-controlled studies, VOYAGE 1 AND VOYAGE 2, evaluated the efficacy and safety of Tremfya compared to placebo and adalimumab in patients with moderate to severe plaque psoriasis (PsO). In both studies, significantly more patients receiving Tremfya achieved the coprimary endpoints of an IGA (Investigator's Global Assessment) score of cleared (0) or minimal (1) and 90% (percent) improvement in Psoriasis Area and Severity Index (PASI 90) response at week 16 versus placebo (P<[less than]0.001). IGA (Investigator's Global Assessment) 0, IGA (Investigator's Global Assessment) 0 or 1, and PASI 90 (90% improvement in Psoriasis Area and Severity Index) responses were also significantly higher in patients receiving Tremfya versus adalimumab throughout the studies (P<0.001).

A Network Meta-Analysis (NMA) compared first-in-class interleukin (IL)-23 inhibitor Tremfya (guselkumab) to all advanced therapies approved for active psoriatic arthritis using data from 33 Phase 3 randomized clinical trials The NMA (network meta-analysis)  concluded Tremfya ranked highest for skin clearance based on PASI 90 (90% improvement in Psoriasis Area and Severity Index) response among 23 treatment regimens (15 unique treatments including IL [interleukin]-23 inhibitors like Tremfya and risankizumab, subcutaneous tumor necrosis factor inhibitors, and Janus kinase inhibitors). Cosentyx can worsen IBD (inflammatory bowel disease), and TNF (tumor necrosis factor) alpha inhibitors can worsen neuropathy; also, they all carry an increased risk of serious infection. Since the patient has HIV (Human Immunodeficiency Virus), these are not optimal choices.

Therefore, given the above, the requested Tremfya is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Back pain/injury.
Treatment: Personal Care Aide Services: 56 Hours per Week, Consumer Direct, 1 Client
The insurer denied Personal Care Aide Services: 56 Hours per Week, Consumer Direct, 1 Client. 
The health plan's determination is overturned. 

The patient is a male with past medical history of nicotine dependence, mitral regurgitation, anxiety, insomnia, urinary incontinence, low back pain, osteoarthritis, neck pain, neuropathy, migraines, and traumatic head injury who had been injured when a bathroom room collapsed on him. The patient had injury to shoulder, neck and head injury. 

Personal Care Aide Services: 56 Hours per Week, Consumer Direct, 1 Client medically necessary for this patient.
There is documentation from the patient's medical provider multiple times of medical necessity of increased PCA (personal care aide) services initially recommended prior to him having neck surgery and subsequently following his surgery. The patient had assessment performed prior to surgery which would have underestimated his activities of daily living (ADL) and Instrumental activities of daily living (IADL) needs. Furthermore, the patient will need to have another surgery on his shoulder and will have continued increased ADL and IADL needs. The denial stated that the medical provider did not document why the patient's care needs cannot be completed and currently assigned hours however the medical provider documented medical necessity of increased PCA services and specifically outlined the assistance the patient needed. The patient did require limited assistance with toilet use which is an unpredictable and unscheduled care need that spans a continuum of time and the patient would need assistance outside of the time that he has informal support. The insured did not document a plan to meet these unpredictable and unscheduled care needs. 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, PCA services 56 hours/week are medically necessary for this patient. 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 his own home.