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

Diagnosis: Low back pain
Treatment: L5-S1 epidural steroid injection
The insurer denied coverage for an L5-S1 epidural steroid injection
The denial is overturned

This adult female has a history of low back pain (LBP) secondary to lumbar spondylosis, lumbosacral radiculopathy and lumbar disc degeneration. She initially presented to her doctor for evaluation of acute on chronic lower back pain. Imaging results of magnetic resonance imaging (MRI) were reviewed at the visit, and physical therapy (PT) was recommended as well as a lumbar (L) interlaminar epidural injection (72323 x [times] 1 unit). An undated follow-up visit note indicates that a prior left L5/S1 (lumbar/sacral) epidural steroid injection on provided over 80% relief for 3+ (plus) months. The pain gradually returned, especially over the past month, and the patient was having difficulty with activities of daily living (ADLs). The notes document that the patient has had over 8 weeks of PT. She has tried nonsteroidal anti-inflammatory drugs (NSAIDs), and analgesic ointments. The request is for an L5-S1 epidural steroid injection.

A recent Cochrane review (2) of epidural steroid injections was published and found in "25 clinical trials (from 29 publications) providing data for a total of 2470 participants with sciatica, an increase of six trials when compared to the previous review. Epidural corticosteroid injections were probably more effective than placebo in reducing short-term leg pain (MD (mean difference) -4.93, 95% CI (confidence interval) -8.77 to -1.09 on a 0-100 scale), short-term disability (MD -4.18, 95% CI: -6.04 to -2.17 on a 0-100 scale) and may be slightly more effective in reducing short-term overall pain (MD -9.35, 95% CI -14.05 to -4.65 on a 0-100 scale). There were mostly minor adverse events (i.e., without hospitalization) after epidural corticosteroid injections and placebo injections without difference between groups (RR (relative risk) 1.14, 95% CI: 0.91-1.42). The quality of evidence was at best moderate mostly due to problems with trial design and inconsistency. 

They concluded: A review of 25 placebo-controlled trials provides moderate-quality evidence that epidural corticosteroid injections are effective, although the effects are small and short-term. There is uncertainty on safety due to very low-quality evidence. 

Manchikanti et al (1) set a measure of success for therapeutic epidurals as 50% pain relief for 3 months. This patient met that criterion.

The patient's previous epidural steroid injection was successful by accepted criteria. The duration of action is also typical and repeat epidural steroid injections can be performed as long as the total dose of steroid per year is monitored.

The health care plan did not act reasonably, with sound medical judgement or in the best interest of the patient. The requested pain management injection is considered medically necessary.

The insurer's denial of coverage for pain management injection is reversed. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Diabetes Mellitus

Treatment: continued inpatient rehabilitation services

The insurer denied coverage for continued inpatient rehabilitation services

The denial is upheld.

This is a patient with chronic medical problems including end stage renal disease on dialysis, hypertension and diabetes mellitus.  She was admitted to the skilled nursing facility (SNF) for subacute rehabilitation.  Under review is the medical necessity for continued inpatient rehabilitation services.

The patient was initially appropriate for the SNF subacute rehabilitation level of care (1, 2, 3).  Her clinical condition and functional deficits were amenable to medical intervention and comprehensive rehabilitation.  She participated in physical therapy with demonstrated modest and gradual improvement.  Physical therapy notes indicates that the patient required supervision for transfer tasks.   Ascending/descending steps required minimal assistance.    She was able to ambulate 100 feet with contact guard assistance.   There was no occupational therapy or more recent physical therapy notes submitted for review.  The provided therapy notes are insufficient to support the medical necessity for continued inpatient rehabilitation services to discharge. In addition, there were no specific acute medical or complicated nursing issues that required continued stay at the SNF for the time period under review.  

From a physical medicine and rehabilitation perspective continued inpatient rehabilitation services to discharge were not medically necessary.

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 continued inpatient rehabilitation services is not substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Allergic Rhinitis. 
Treatment: Dymista. 

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

This is the case of an adult with a history of allergic rhinitis. The treating provider is requesting plan approval for Dymista. 

The patient first tried a combination of fluticasone and azelastine for about two months with no response. A combination of mometasone and azelastine was ordered, with no response. A combination of flunisolide and azelastine was ordered and there was no response. 

"The FDA (food and drug adminstration) has approved a nasal spray fixed-dose combination (Dymista Meda) of the H1-antihistamine azelastine (Astelin, Astepro, and generics) and the corticosteroid fluticasone propionate (Flonase, and generics) for treatment of seasonal allergies." (Azelastine/fluticasone propionate, 2012). 

"Allergic rhinitis is a common disorder that is strongly linked to asthma and conjunctivitis. It is usually a long-standing condition that often goes undetected in the primary-care setting. The classic symptoms of the disorder are nasal congestion, nasal itch, rhinorrhea, and sneezing. A thorough history, physical examination and allergen skin testing are important for establishing the diagnosis of allergic rhinitis. Second-generation oral antihistamines and intranasal corticosteroids are the mainstay of treatment. Allergen immunotherapy is an effective immune-modulating treatment that should be recommended if pharmacologic therapy for allergic rhinitis is not effective or is not tolerated, or if chosen by the patient." (Small, et al., 2018). 

While formulary drug(s) are not likely to cause the patient an adverse reaction. 
The doctor notes that the patient first tried a combination of fluticasone and azelastine for about 2 months with no response. A combination of mometasone and azelastine was ordered, with no response. A combination of flunisolide and azelastine was ordered and there was no response. Only Dymista has provided the patient with any relief. 

The patient has the medical diagnosis of moderate to severe allergic rhinitis. The requested drug would be more effective that the formulary drug(s). The patient has already tried the alternatives. 

The carrier's denial of Request for Formulary Exception for Dymista is overturned.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: History of stroke leading to ataxia and leg spasticity.
Treatment: Botox Injections.
The insurer denied: Botox Injections.
The denial is upheld.

The patient is an adult male with a prior history of stroke leading to ataxia and leg spasticity.  The provider wishes to initiate Botox 200 units per leg. The request was previously denied by the plan as the patient had not tried formulary alternatives including Dysport.

The initiation of Botox for leg spasticity post-stroke is not medically necessary.

The request was previously denied by the plan as the patient had not tried formulary alternatives including Dysport.  Dysport, the formulary alternative, is effective for post-stroke spasticity. In lower limbs, it also has been shown to help increase walking speed. There is no data to suggest that Botox is superior to Dysport.  

Dysport is effective for post-stroke spasticity and there is no data to suggest that Botox is superior to Dysport for this condition.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  S/P (status post) ATV (all terrain vehicle) Accident (traumatic brain injury).
Treatment:  Acute Inpatient Rehabilitation Facility admission.

The insurer denied: Acute Inpatient Rehabilitation Facility admission.  The denial is overturned.

The patient is an adolescent male with a history of multivector polytrauma, including but not limited to traumatic brain injury. Additional injuries were right maxillary sinus fracture, lung contusion, left forearm displaced fracture of the scaphoid, right distal ulnar dislocation, L1 (first lumbar spine vertebra)-L2 (second lumbar spine vertebra) disk bulge.

The patient's initial Glasgow coma scale score was 3. The patient has been undergoing bedside rehabilitative interventions in an acute care facility. The patient has been recommended to continue rehabilitation in acute inpatient rehabilitation unit. The request has been denied coverage by the health plan due to lack of medical necessity. The denial is being appealed.

The Acute Inpatient Rehabilitation Facility admission is medically necessary.

In this case, the child sustained significant brain injury due to polytrauma. The patient developed medical and functional complications requiring intensive medical and rehabilitative interventions. Currently, the patient is clinically stable and is a functionally appropriate candidate for acute inpatient rehabilitative interventions. Medical records clearly state that this patient can sustain 3 hours of skilled rehabilitative interventions with physician supervision. In addition, the patient is not safe to be discharged home with services. Referral to acute inpatient rehabilitation of an adolescent child with significant brain injury and history of polytrauma is congruent with the standards of care in the field of pediatric rehabilitation medicine.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: End stage renal disease

Treatment is personal care services (PCS), 24 hours a day, 7 days a week (live-in)

The insurer denied coverage for personal care services, 24 hours a day, 7 days a week (live-in)
 
The denial is modified

The patient is an elderly patient with chronic medical problems including end stage renal disease and receiving hemodialysis 3 days/week. She was in a skilled nursing facility. She was more recently hospitalized and underwent a gallbladder procedure and scheduled for discharge home within that week. The insurer approved PCS for 8 hours/day, 4 days/week and 5 hours/day, 3 days/week for a total of 47 hours/week. The patient is requesting personal care services, 24 hours a day, 7 days a week (live-in).

The patient was in the hospital when the Uniform Assessment System (UAS) assessment was performed and scheduled for discharge home later that week.  The patient's cognitive status is described as "minimally impaired." The patient is "able to activate PERS [personal emergency response system]. PERS is in place at home." The patient requires maximal assistance for bathing, lower body dressing, walking and toilet transfer/use. She reportedly has a urinary catheter and is continent of bowel. She requires extensive assistance for upper body dressing and bed mobility. The patient is reportedly "able to walk a couple of steps with a rollator at home."   

The patient's functional impairments and extended hospital/nursing facility stay support the medical necessity of increasing personal care services (PCS). This physician would agree the patient may require 24-hour monitoring. However, safety monitoring (e.g., for dementia) under PCW (personal care worker) services does not include monitoring an individual when no other Level I or Level II personal care service task is being provided. In addition, her condition and functional needs are not at a level or unpredictable as to require the requested personal care services, 24 hours a day, 7 days a week (live-in).  

Based on the enclosed documents reviewed, the patient's health and safety can be appropriately provided and maintained by increasing PCS for 12 hours/day, 4 days/week and 9 hours/day, 3 days/week for a total of 75 hours/week.

Based on the above, the insurer's denial is modified. The health care plan did not act reasonably in part and with sound medical judgment and in the best interest of the patient. The medical necessity for personal care services, 24 hours a day, 7 days a week (live-in) services is not substantiated. 12 hours/day, 4 days/week and 9 hours/day, 3 days/week for a total of 75 hours/week is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hepatitis B
Treatment: Vemlidy 25MG (milligram) Tab
The insurer denied: Vemlidy 25MG (milligram) Tab
The denial is upheld

The patient is an adult male with chronic hepatitis B. The plan-preferred agents are generic Viread and entecavir. The patient's provider is requesting treatment with Vemlidy.

The requested Vemlidy is not medically necessary.
There is no medical literature to support that Vemlidy is safer or more effective for the treatment of chronic hepatitis B than generic Viread (tenofovir disoproxil fumarate) or entecavir. Vemlidy is a form of tenofovir that has a similar side effect profile to tenofovir disoproxil fumarate, especially in patients without underlying renal disease. Nausea is a common side effect with Vemlidy as well. The concerns about nausea and the patient's GERD (gastroesophageal reflux disease) are not a contraindication to tenofovir disoproxil fumarate.

Therefore, given the above, the requested Vemlidy is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: systemic sclerosis

Treatment is Rituxan (rituximab)

The insurer denied coverage for Rituxan (rituximab
 
The denial is overturned

This is a patient with a history of inflammatory arthritis, systemic sclerosis, Sjogren's syndrome, and polymyositis. The patient has tried and failed Remicade and intravenous immunoglobulin (IVIG). The treating provider is requesting therapy with rituximab.

Per Caldas, M., Neto, F., Azevedo, K., Pimenta, I., Oliveira, A., & Piuvezam, G. (2019), "Systemic sclerosis (SSc) is a clinically complex and challenging disease, the most frequent complication of which is interstitial lung disease (ILD), which leads to a worse prognosis. In this situation, cyclophosphamide is considered the criterion standard for treatment, despite the controversies regarding its efficacy and toxicity. However, studies using rituximab (RTX) have shown that this drug may be a promising therapeutic option."

Per de Figueiredo Caldas, M., et al., (2021), "Rituximab is a promising strategy for the SSc-associated ILD and cutaneous fibrosis treatment."

Per de Souza, F., Miossi, R., de Moraes, J., Bonfa, E., & Shinjo, S. K. (2018), "Interpretation of rituximab efficacy for refractory idiopathic inflammatory myopathies (IIM) is hampered by the absence of a uniform definition of refractory myositis and clinical response. Therefore, rigorous criteria of refractoriness, together with a homogenous definition of clinical improvement, were used to evaluate rituximab one-year response. This study provides convincing evidence that rituximab is an effective and safe therapy for refractory IIM."       

This patient has a complicated medical history with a combination of multiple serious autoimmune diseases that have high mortality and morbidity if not treated appropriately. The patient has tried and failed other appropriate treatment, but still has progression of symptoms. Multiple studies have shown the effectiveness of Rituxan in the treatment of scleroderma and polymyositis. Rituxan should be approved for this patient.
  
The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. Rituxan (rituximab) is considered medically necessary for this patient.
                                             
Based on the above, the insurer's denial must be overturned. The medical necessity for Rituxan (rituximab) services is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Systemic sclerosis
Treatment: Rituxan (rituximab)
The insurer denied coverage for Rituxan (rituximab).
The denial is overturned.

This is a patient with a history of inflammatory arthritis, systemic sclerosis, Sjogren's syndrome, and polymyositis. The patient has tried and failed Remicade and intravenous immunoglobulin (IVIG). The treating provider is requesting therapy with rituximab.

Per Caldas, M., Neto, F., Azevedo, K., Pimenta, I., Oliveira, A., & Piuvezam, G. (2019), "Systemic sclerosis (SSc) is a clinically complex and challenging disease, the most frequent complication of which is interstitial lung disease (ILD), which leads to a worse prognosis. In this situation, cyclophosphamide is considered the criterion standard for treatment, despite the controversies regarding its efficacy and toxicity. However, studies using rituximab (RTX) have shown that this drug may be a promising therapeutic option."

Per de Figueiredo Caldas, M., et al., (2021), "Rituximab is a promising strategy for the SSc-associated ILD and cutaneous fibrosis treatment."

Per de Souza, F., Miossi, R., de Moraes, J., Bonfa, E., & Shinjo, S. K. (2018), "Interpretation of rituximab efficacy for refractory idiopathic inflammatory myopathies (IIM) is hampered by the absence of a uniform definition of refractory myositis and clinical response. Therefore, rigorous criteria of refractoriness, together with a homogenous definition of clinical improvement, were used to evaluate rituximab one-year response. This study provides convincing evidence that rituximab is an effective and safe therapy for refractory IIM."       

This patient has a complicated medical history with a combination of multiple serious autoimmune diseases that have high mortality and morbidity if not treated appropriately. The patient has tried and failed other appropriate treatment, but still has progression of symptoms. Multiple studies have shown the effectiveness of Rituxan in the treatment of scleroderma and polymyositis. Rituxan should be approved for this patient.
  
The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. Rituxan (rituximab) is considered medically necessary for this patient.
                                             
Based on the above, the insurer's denial must be overturned. The medical necessity for Rituxan (rituximab) services is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Osoriasis
Treatment: Tremfya 100 MG(milligrams)/ML (milliliter) SC (subcutaneous) SOPN (solution pen injector)
The insurer denied coverage for Tremfya 100 MG(milligrams)/ML (milliliter) SC (subcutaneous) SOPN (solution pen injector)
The denial is overturned

The patient is teenager with severe psoriasis affecting >50% total body surface area (TBSA), IGA (Immunoglobulin A) 4. The patient has failed therapy with Methotrexate, prednisone, Stelara, ultraviolet (UV) therapy, and multiple topical steroids. The request is for Tremfya.  

Per the medical and scientific literature and evidence based clinical practice guidelines, and the information provided by the patient, the request for Tremfya is medically necessary. The patient has failed multiple systemic agents, including Methotrexate, Stelara, prednisone, and UV therapy. The patient has severe disease requiring systemic therapy. Tremfya would appear to be reasonable treatment option for this patient having failed methotrexate, light therapy, prednisone, and Stelara. The joint AAD-NPF (American Academy of Dermatology and the National Psoriasis Foundation) guidelines for psoriasis treatment with biologics states that Tremfya is recommended for monotherapy in the treatment of psoriasis.  With regard to acitretin as per Up to Date, "Acitretin is teratogenic; it is only indicated in men and in women of nonreproductive potential. Pregnancy is contraindicated for three years after discontinuing the drug." They also note that PUVA (psoralen and ultraviolet A) is a contraindication to the use of cyclosporine. 

Based on the submitted documentation, Tremfya is approved, and the decision is overturned in whole based on the current evidence-based medical literature.

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 Tremfya 100 MG/ML SC SOPN services is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Anterior crossbite on teeth 7 and 10.
treatment: braces/monthly visits.
The insurer denied braces/monthly visits. 
The health plan's determination is overturned.

The patient in question is a male with an anterior crossbite on teeth 7 and 10. Tooth 4 is also in crossbite. He presents with a skeletal Class I malocclusion with moderate crowding in the maxilla and mandible. He is treatment planned for Braces and Monthly Visits. 

The braces and monthly visits are medically necessary. Teeth 7 and 10 are in a traumatic crossbite with their mandibular antagonists. If this is not corrected the damage that will likely occur to the patient's teeth will be much more time consuming and costly to correct than the patient's existing orthodontic problem.
This patient presents with an anterior crossbite on teeth 7 and 10, as well as crowding. Side effects of an untreated anterior crossbite include abnormal wear to the affected teeth and labial displacement of the mandibular incisors that can lead to periodontal defects.