Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease. 
Treatment:  Stelara 90 mg/ml (milligrams/milliliter) syringe at a dosing of every 4 weeks. 
The insurer denied Stelara 90 mg/ml syringe at a dosing of every 4 weeks. 
The health plan's determination is overturned. 

The patient is a female with stricturing and fistulizing Crohn's disease, status post ileocectomy. She had hospital admission for a partial small bowel obstruction, requiring corticosteroids. A colonoscopy showed diffuse inflammation and narrowing of the neo-terminal ileum at the anastomosis with non-traversable stricture, ulceration, and erythema. She has failed azathioprine, infliximab, and adalimumab. She started Stelara with response. 

Stelara 90 milligrams (mg) every 4 weeks is likely to be more beneficial than any standard treatment or treatments for the insured's Crohn's disease. In this case, the patient had initial response to Stelara, and has had active disease symptoms and objective evidence of active disease (colonoscopy with ileal and colonic inflammation, and anastomosis stricture with ulceration) in the setting of low Stelara level. The American College of Gastroenterology guidelines for the treatment of Crohn's disease state that "Those with continued symptoms should...ave their medication dose adjusted in order to attempt to optimize therapy" (Lichtenstein, et al). A relationship between Stelara level and inflammatory markers has been shown; Stelara levels have been shown to correlate with "clinical and histologic efficacy and markers of inflammation", and a Stelara level of at least 4.5 is associated with effective disease control (Restellini, et al; Battat, et al). Continued use of Stelara every 8 weeks or discontinuation of Stelara (even if an alternative is attempted immediately) may result in loss of disease control, with complications such as stricture, fistula, bowel obstruction, flare, hospitalization, need for further surgery, or other complications in this patient with severe stricturing and fistulizing disease which has required surgery at a young age. For these reasons, Stelara 90 mg every 4 weeks is likely to be more beneficial than any standard treatment or treatments for the insured's Crohn's disease.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease. 
Treatment:  Stelara 90 mg/ml (milligrams/milliliter) syringe at a dosing of every 4 weeks. 
The insurer denied Stelara 90 mg/ml syringe at a dosing of every 4 weeks. 
The health plan's determination is upheld. 

The patient is a female with underlying Crohn's disease. The patient had a previous ileo-colectomy. She has tried and failed infliximab and adalimumab in the past and has received azathioprine in the past. The patient was started Stelara and noted at her recent office visit that she does get benefit from Stelara but this does not last the entire 8 weeks between injections.

Stelara 90 mg/mL (milligrams/milliliter) Syringe at a Dosing of Every 4 Weeks is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 
To approve an increase of ustekinumab dosing to Q (every) 4 weeks it is necessary to provide specific objective evidence of ongoing non-responding or worsening disease activity. Examples would include an elevation of serum C-reactive protein (CRP) or fecal calprotectin from baseline. Other examples would include evidence of lack of improvement/worsening on cross-sectional imaging or endoscopy. Requirement for steroids or hospitalization would also be compelling factors in favor of dose elevation. A slightly low trough ustekinumab level measured once is not sufficient to justify a doubling of the Stelara dose. Therefore, the requested Stelara dosing is not indicated in this case.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease. 
Treatment:  Stelara 90 mg/ml (milligrams/milliliter) syringe at a dosing of every 4 weeks. 
The insurer denied Stelara 90 mg/ml syringe at a dosing of every 4 weeks. 
The health plan's determination is overturned. 

This is a female patient who has severe ileocolonic Crohn's disease and has had prior bowel resection. She has previously tried and failed steroids, an immunomodulator (azathioprine) and two anti-tumor necrosis factor (TNF) agents (infliximab & adalimumab). She was started on Stelara and did well initially on Stelara at standard dosing every 8 weeks but recently lost response. 

Stelara 90 mg/mL (milligrams/Milliliter)Syringe at a Dosing of Every 4 Weeks is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 
Since this patient was not responding to standard dosing of Stelara, it is reasonable to increase the dose of Stelara to 90 mg every 4 weeks. Dose escalation in biologic therapy used in inflammatory bowel disease can be done either based on clinical symptoms or laboratory markers or endoscopic or radiological features with or without therapeutic drug monitoring. Dose escalation is done either by increasing the dose of the medication or shortening the interval between doses or sometimes a combination of both. There are only a finite number of biological agents used to treat inflammatory bowel disease and the standard of care is to optimize dose of the biological agent before switching to another agent. Therefore, it is necessary to use Stelara 90mg SC (subcutaneous) every 4 weeks to treat this patient's severe Crohn's disease. 
Ollech and colleagues showed that shortening the ustekinumab 90 mg dose interval to 4 weeks for patients with CD (Crohn's disease) who did not respond to doses every 8 weeks improved clinical and biological indices of disease activity. Patients who lose response to the standard dose of ustekinumab might benefit from dose interval shortening, which was effective and safe. Meserve and colleagues showed that in real world settings, ustekinumab dose escalation was effective in achieving response in patients with CD with inadequate response, or loss of response to standard dose induction and/or maintenance therapy.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: decreased mobility
Treatment: Personal Care Aide (PCA) Services: 12 Hours per Day, 7 Days per Week + 12 Hours per Day, 7 Days per Week (Split-Shift) - Total of 168 Hours per Week
The insurer denied Personal Care Aide (PCA) Services: 12 Hours per Day, 7 Days per Week + 12 Hours per Day, 7 Days per Week (Split-Shift) - Total of 168 Hours per Week
The health plan's determination is overturned.

This is a case review for a female with medical history notable for mobility issues, incontinence, and lymphedema. The patient's physician provided a letter of support for this appeal. The letter states that the patient's current personal care hours are inadequate to meet her needs and recommends 24 hour care. The patient has severe osteoarthritis, chronic pain, obesity, unsteady gait, incontinence, and physical deconditioning. She has a history of open pressure wounds secondary to prolonged sedation. She requires assistance during the day and night for toileting, transfers, and ambulating. The physician states she needs frequent diaper changes to prevent infection as well as repositioning in bed every 2-4 hours to prevent skin breakdown. The physician attests that around the clock care is medically necessary for the patient.

The requested Personal Care Aide (PCA) Services: 12 Hours per Day, 7 Days per Week + 12 Hours per Day, 7 Days per Week (Split-Shift) - Total of 168 Hours per Week is medically necessary for this patient.
The patient has advanced functional limitations and requires human assistance for all activities of daily living (ADL), including toileting, transfers, and incontinence care. She has a history of skin breakdown and requires maximal assistance for bed mobility. The patient's personal care needs are by definition continuous and unscheduled throughout the day and night. Furthermore, the night time care logs demonstrate that the patient has personal care needs that continue through all hours of the night. The requested increase in personal care hours is therefore medically necessary for the patient. Failure to provide for her personal care needs could result in skin breakdown and/or infection.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous Basivertebral Nerve Ablation (64628, 64629)
The insurer denied: Intraosseous Basivertebral Nerve Ablation
(64628, 64629)
The denial is upheld.

The patient is a 45-year-old male. The appeal letter notes the patient has a history of chronic low back pain due to degenerative disc disease that resulted in the development of vertebrogenic pain identified by degenerative endplate changes noted as Modic on magnetic resonance image (MRI). The patient has had pain for more than six months and failed treatment for greater than six months. Prior treatments include lumbar steroid injection and medication. 
The patient was being seen for an initial pain management visit for low back pain. The patient had an epidural steroid injection that gave the patient greater than 80% relief for four to five months. The patient reports back pain greater than leg pain. The pain radiates to the right groin and left thigh. It is constant and aggravated with sitting and bending forward. The patient's exam showed paraspinal and lumbar tenderness. Straight leg raise was equivocal bilaterally. 
The plan was to proceed with a repeat epidural steroid injection. 

The health plan should not cover the proposed treatment. 
Based on the documentation provided, the requested Intracept procedure is not recommended at this time. Though the patient has a history of low back pain with radicular symptoms, there was a lack of documentation of the patient having tried and failed all prior conservative treatments, including formal physical therapy. Additionally, there was a lack of documentation if the patient had proceeded with a second injection since the first provided greater than 80% pain relief for four to five months. Therefore, the health plan should not cover the proposed treatment.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous Basivertebral Nerve Ablation (64628, 64629)
The insurer denied: Intraosseous Basivertebral Nerve Ablation
(64628, 64629)
The denial is upheld.

The patient is an adult male with low back and left leg pain that began over six months ago. Past treatments include cyclobenzaprine, methylprednisolone, oxycodone, and epidural steroid injection. The patient's pain ranges from 4/10 to 10/10. Magnetic resonance image (MRI) of the lumbar spine from last year shows Modic type I endplate changes at L4-S1, Modic type II endplate changes at L2-3, mild degenerative disc disease at L2-L5, small disc herniations at L2-L5, left foraminal disc herniation at L3-4, and small Schmorl's node at superior endplates of L4 and L5. The request for Intracept was denied as there is not enough proof it improves health and, therefore, is investigational. 

The health plan should not cover the proposed treatment. 

A review of the literature shows moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic back pain who are selected based on Type I or Type II Modic changes as well as other inclusion and exclusion criteria used in the published literature to date. However, non-industry funded high-quality, large prospective studies are needed to confirm these findings. 
At this time there is not enough valid scientific evidence to show that the expected health benefits from the procedure, supply, equipment, or service are clinically significant and will have a greater chance of benefit, without a disproportionately greater risk of harm or complications, than other possible treatments; and that generally approved forms of treatment that are less invasive have been tried and did not work or are otherwise unsuitable. There is a lack of sufficient (enough) peer-reviewed literature and data regarding the long-term outcomes of the procedure. As such, the health plan should not cover the proposed treatment.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous Basivertebral Nerve Ablation (64628, 64629)
The insurer denied: Intraosseous Basivertebral Nerve Ablation
(64628, 64629)
The denial is upheld.

The patient is an adult male with chronic low back pain for whom an intercept procedure has been requested. The procedure was denied as experimental/investigational. The patient has failed epidural steroid injections. The patient has failed multiple medications including potent opiate medications. MRI (magnetic resonance image) shows modic changes. The physical exam does not reveal any neurological injury. 

The health plan should not cover the proposed treatment. 

The requested Intracept procedure is not medically appropriate. The requested health service or procedure is not likely to be more beneficial than standard treatments. The patient is an adult male with chronic low back pain for whom an intercept procedure has been requested. The procedure was denied as experimental/investigational. The patient has failed epidural steroid injections. The patient has failed multiple medications including potent opiate medications. MRI (magnetic resonance image) shows modic changes. The physical exam 
does not reveal any neurological injury. The Intracept procedure (interosseous basivertebral nerve ablation) is not an intradiscal procedure. It is a new Food and Drug Administration (FDA) approved intraosseous nerve ablation for the treatment of chronic low back pain in the treatment of vertebrogenic-related chronic low back pain. It is typically used in patients with significant Modic type 1 or type 2 vertebral endplate changes, typically in situations where conventional and typical options have been exhausted. However, the patient has not failed or attempted facet interventions or sacroiliac joint injections, which are common causes of axial low back pain. There is no documentation of failed conservative treatment such as physical therapy. The Intracept procedure should be employed after all conventional and evidence-proven alternatives have failed. The literature has not shown superiority over conventional, less invasive treatments, which is the basis for the denial. Given that the alternative sacroiliac injections do show favorable outcomes in the literature, and have lower risk, and morbidity, the requested Intracept procedure is not medically appropriate. The procedure is an FDA (Food Drug Administration) approved procedure for axial low back pain. It has been shown effective in RCT (randomized clinical trial) with 5-year results. The Intracept procedure (interosseous basivertebral nerve ablation) is not an intradiscal procedure. It is a new Food and Drug Administration (FDA) approved intraosseous nerve ablation for the treatment of chronic low back pain in the treatment of vertebrogenic-related chronic low back pain. It is typically used in patients with significant Modic type 1 or type 2 vertebral endplate changes, typically in situations where conventional and typical options have been exhausted.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Recurrent Glioblastoma

Treatment: Lenvima

The insurer denied coverage for Lenvima

The denial is upheld 

The patient has recurrent grade 4 (IV) glioblastoma. The patient has had many different treatments including resection, proton beam, temozolomide, and peptide vaccines. Lenvima is being requested; this will be in combination with the current pembrolizumab. The request for Lenvima is under review.

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

There is not sufficient evidence for a combination of lenvatinib and pembrolizumab. At the 2020 European Society of Medical Oncology (ESMO) meeting, Lwin, Z., et al. (2020) presented the results of the LEAP-005 study: a phase II basket trial including 31 patients with recurrent glioblastoma (rGBM), treated with the association of lenvatinib plus pembrolizumab. The authors reported interesting results: the objective response rate (ORR) and the disease control rate (DCR) were 16.1% (95% confidence interval [CI], 5.5-33.7) and 58.1% (95% CI, 39.1-75.5), respectively.      

The patient has undergone several different therapies. There has only been one early study pertaining to treatment with Lenvima in combination with pembrolizumab.  As such, Lenvima is not considered medically necessary and is denied.

Lenvima is a kinase inhibitor that is indicated:
-	For the treatment of patients with locally recurrent or metastatic,
progressive, radioactive iodine-refractory differentiated thyroid cancer
(DTC);
-	In combination with everolimus, for the treatment of patients with
advanced renal cell carcinoma (RCC) following one prior antiangiogenic therapy
-	For the first-line treatment of patients with unresectable hepatocellular
carcinoma (HCC)" (1).

"Glioblastoma (GBM) is the most common primary brain tumor in adults and exhibits high aggressiveness, with a median overall survival (OS) time of less than 2 years and a 5-year OS rate of less than 10%. GBM represents one of the greatest therapeutic challenges of the modern era, with a low cure rate, high recurrence rate, and limited survival time. Therapeutic options are extremely limited at both the time of new diagnosis and relapse" (4).

Finally, the National Comprehensive Cancer Network (NCCN) makes no mention of the use of lenvatinib for central nervous system (CNS) tumors. 

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 Lenvima is not substantiated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Attention deficit hyperactivity disorder.
Treatment:  Jornay.
The insurer denied Journay.  The determination is upheld.

The patient is a male requesting Jornay for the management of attention deficit hyperactivity disorder. There is no indication of prior trials of formulary alternatives inclusive of amphetamine-dextroamphetamine mixed salts extended release (ext-rel), dexmethylphenidate ext-rel, dextroamphetamine ext-rel, mehtylphenidate ext-rel, Azstarys. There is no indication that the patient has any intolerance or contraindication to the available formulary alternatives. At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.

There is no indication that all available formulary alternatives have been trialed and failed, nor any indication that these alternatives would be ineffective compared to the requested medication. Per generally accepted standards of care and industry standards, management of attention deficit hyperactivity disorder (ADHD) with stimulant medication can be beneficial, but there is no indication that one class or specific medication (or brand name compared to generic) is superior to another. As such, there is no indication or industry standard guideline indicating that the available formulary alternative medications would be ineffective or not as effective as the requested non-formulary medication (Jornay), nor that they would be more likely to have adverse effects compared to the requested non-formulary medication (Jornay). As a result, the requested Jornay medication is not indicated at this time as there are available formulary alternatives for management of the patient's ADHD concerns.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Type 2 diabetes mellitus with hyperglycemia
Treatment: Mounjaro
The insurer denied Mounjaro
The health plan's determination is upheld

This is a female patient diagnosed with Type 2 diabetes mellitus with hyperglycemia. This request is for Mounjaro. As per the letter, she was previously on Ozempic. She could not tolerate Ozempic due to side effects including bloating, diarrhea and constipation.
As per a visit note, she is currently on metformin and Glipizide. She tried and failed Ozempic due to gastrointestinal (GI) side effects. Januvia was changed to Ozempic. She failed Jardiance due to yeast infections. She is on Dexcom G7 sensors.
Her glycated hemoglobin (A1C) test on 10/2023 was 7.5 percent (%); on 2-2023 it was 6.5 %; on 7-2022 it was 7 %; and on 11-2019 it was 9.8 %. At issue is the medical necessity of Mounjaro.

The remaining formulary alternatives would be as effective as the requested medication. The patient is reported to have only failed Ozempic.
The requested medication Mounjaro (Trizepatide) is United States Food and Drug Administration (FDA) approved for the treatment of adults with type 2 diabetes. It is a glucagon-like peptides 1 (GLP-1) and a glucose-dependent insulinotropic peptide (GIP) receptor agonist. It has been shown in clinical trials to lead to improvement in hemoglobin A1c as well as weight loss [1-3].
There are no studies demonstrating the superiority of the requested medication over the formulary alternatives. The most recent American Diabetes Association guidelines recommend using GLP-1 receptor agonists as a first line agent. There is no preference for the requested medication over GLP-1 receptor agonists [4]. The patient has only failed Ozempic due to side effects. The patient can try one more formulary alternative. The request is not consistent with generally accepted standards of medical practice and is therefore not medically necessary.
Therefore, the remaining formulary alternatives, Trulicity and Victoza would be as effective as the requested medication.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Peripheral Arterial Disease
Treatment: Surgery (peripheral arterial revascularization)
The insurer denied: Surgery (peripheral arterial revascularization)
The denial is upheld.

The patient is an adult female with claudication and arterial occlusive disease. She has a history of diabetes, fibromyalgia, and tobacco abuse.

The requested peripheral arterial revascularization is not medically necessary.

According to the progress note, the patient is an adult female with leg pain. The patient has short claudication symptoms of burning sensation. The patient had a previous arteriogram last year. The patient had skin changes in left second toe. Ankle Brachial Index (ABI) on the right is 0.44. On the left it is 0.50. The patient also has back pain. She had diabetes and was an active 
smoker. The requested procedure is not medically necessary, because there is no documentation that the patient has significant symptoms that affect her activities of daily living. The patient is not documented to have tried and failed conservative therapy, including supervised exercise program, or medications, including Pletal, as well as smoking cessation. The patient has no rest pain, ulcer, or gangrene. Therefore, the requested health service is not medically necessary.