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

Diagnosis: Benign Prostatic Hypertrophy (BPH)

Treatment: medical procedure (37242 x 2, 37243 x 2, 37244 x 2), prostate embolization

The insurer denied coverage for medical procedure (37242 x 2, 37243 x 2, 37244 x 2), prostate embolization.  The denial is upheld.

This is patient has a past medical history of Benign Prostatic Hypertrophy (BPH), hypertension, coronary artery disease, who presented to the IR [Interventional Radiologist's] office for follow up of persistent hematuria. The patient also reports urgency, frequency, and nocturia. The patient is not felt to be a candidate for transurethral resection of the prostate (TURP). The treating physician requested PAE (prostate artery embolization) to treat his urinary symptoms. 

The insurer has denied coverage for PAE and stated that the role of this procedure remains uncertain, and there are currently no proven indications for this procedure. 

The appeal on the patient's behalf is noted and read in detail. 

PAE is FDA (Food and Drug Administration) approved for recurrent hematuria from BPH. However, the best results come from large prostates (90 grams) with recurrent gross hematuria. This patient had an ultrasound of the prostate that revealed a prostate volume of only 36 grams. Also, this patient has not been tried on standard prostate shrinking medications, such as finasteride or dutasteride, which are very effective for hematuria due to BPH. PAE is not yet considered a standard care, and additional comparative studies (PAE vs [versus] TURP (Transurethral resection of the prostate)) with longer term follow up will be necessary to establish the role of PAE in the BPH treatment paradigm.

PAE has best results with prostate size > (greater than) 80-90 gram and hematuria, which this patient does not have. This patient's prostate is 36 gram by US (United States) measurement and the patient is not on a prostate shrinking medication. PAE is FDA approved for recurrent hematuria from BPH. PAE is not the best available treatment for this patient at this time.  PAE has risks of urinary tract infection (UTI), dysuria, and bladder spasms. Acute urine retention occurs in 8% of patients. Given the data available, PAE is not likely to be any more beneficial than any of the standard treatment or procedures for this patient.

In summary, the denial of medical procedure (37242 x 2, 37243 x 2, 37244 x 2), prostate embolization and coverage for the treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: Intracept procedure
The insurer denied the Intracept procedure.
The denial is upheld.

The patient is a female diagnosed with low back pain. Records indicate the patient was recommended to undergo the Intracept procedure. This was denied by her health plan.
There is a letter of appeal from the provider stating that they disagree with the denial of the Intracept procedure as this treatment is based on 30 years of science and intraosseous ablation of the basivertebral nerve is an innovative procedure to address chronic back pain identified by Modic changes and fulfills a treatment gap for patients with chronic low back pain. It was noted the patient has a history of low back pain that began over a year ago and has tried multiple treatments including acupuncture, medial branch block injections, medication management, physical therapy, radiofrequency ablation, spinal cord stimulator and trigger point injections. Medications have included Cymbalta, Lyrica and tramadol. Pain has significantly impacted activities of daily living, and nothing has provided significant sustained benefit. Pain ranges from 4-6/10. It was reported the patient had a magnetic resonance imaging (MRI) performed demonstrating Modic changes at disk space lumbar (L)5 - sacral (S)1 and therefore her chronic back pain is coming from vertebrogenic changes at L5 - S1. The provider is requesting reconsideration for approval of this procedure.

There is no evidence that the proposed Intracept procedure is likely to be more beneficial than any standard treatment or treatments for the patient's condition. The patient is noted to have a history of chronic back pain that has not responded to conventional conservative treatment. The provider feels that the patient's pain is coming from Modic changes at L5 and S1 and was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation), although it should be noted there was no mention of Modic changes on the MRI. This procedure remains experimental and not the standard of care, as there is a lack of high-quality studies evaluating the long-term risks and benefits of this procedure. Although some results have been promising, additional studies are needed to establish the safety and efficacy.

This treatment is not currently considered standard of care in the general medical community. There is a lack of high-grade evidence and large, long-term studies found in the peer-reviewed medical literature demonstrating this treatment to be either safe or effective or resulting in superior benefits over that of other standard means of treatment. Additional studies are needed to evaluate long-term risks and benefits of this procedure. There is no evidence that the proposed health service or treatment is likely to be more beneficial than any standard treatment or treatments for the patient's condition.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: Intracept procedure
The insurer denied the Intracept procedure.
The denial is overturned.

The patient is a female who has chronic low back pain. Her pain is located in the middle of her lower back and radiates towards the left into the top of her buttock. The pain is worse with flexion and prolonged sitting. Her pain level ranges from 4-6/10. She had tried physical therapy (PT), acupuncture, lumbar epidural injections, radiofrequency ablation (RFA), tramadol and gabapentin without adequate improvement. The physical exam shows tenderness to palpation (TTP) left paraspinal region, positive facet loading, lumbar spine decreased range of motion (ROM). The magnetic resonance imaging (MRI) shows Modic changes at lumbar (L)5/sacral (S)1 and mild multilevel degenerative disc disease. This patient was recommended to have the Intracept procedure at L5-S1.
The issue is whether the Intracept procedure is likely to be more beneficial for this patient for her back pain than standard therapy.

The proposed treatment is likely to be more beneficial for the patient than any standard treatment.

The Intracept system was designed to treat low back pain from vertebral body by ablating intraosseous nerves. There are multiple clinical trials demonstrating the effectiveness of this intervention. This patient has persistent back pain consistent with vertebrogenic pain. She had failed extensive treatments PT, acupuncture, lumbar epidural injections, RFA, tramadol and gabapentin. Further interventions are required to improve her pain and functional level. Other potential treatment options are long-term use of medications [non-steroidal anti-inflammatory drugs (NSAIDs), opioids] and lumbar decompression fusion surgery. However, none of these options has a high success rate, and all of them carry significant risks and complications. Given this clinical scenario, Intracept procedure is the appropriate next step intervention and likely to be more beneficial for this patient than any other treatment.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: Intracept procedure
The insurer denied the Intracept procedure.
The denial is upheld.

The patient is a female with low back pain, present for 1 year, rated 4-6 out of 10. Prior treatments have included acupuncture, lumbar injections, physical therapy, spinal column stimulator. The patient has previously tried multiple medications, including tramadol. Activities of daily living are impacted secondary to the pain. Magnetic resonance imaging (MRI) of the lumbar spine demonstrated multilevel degenerative changes including vertebra genic changes at lumbar (L) 5-sacral (S) 1. There is a request for the Intracept procedure.

The proposed Intracept procedure is not likely to be more beneficial than any standard treatment or treatments for the patient's condition. The patient has complaints of low back pain. There is a request for intraosseous basivertebral nerve ablation. This procedure is not recommended. Despite promising early reports, further trials with longer-term outcomes and less risk of bias are required. A Food and Drug Administration (FDA) investigational device exemption trial examined 225 chronic low back pain patients with type I or II Modic changes who were randomized to the requested procedure or sham treatment, resulting in decreased Oswestry disability index (ODI) of 20.5 and 15.2 points, respectively. The authors noted that these marginally clinically meaningful improvements suggested some potential as a minimally invasive treatment; however, there is lack of data to recommend this procedure as treatment modality. In general, there is lack of substantial support for this procedure, and it is currently not considered standard of care.
Given the above, the proposed treatment is not likely to be more beneficial than any standard treatment for the patient's condition.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Dermatitis
Treatment: Dupixent
The insurer denied Dupixent.
The denial is upheld.

The patient is a female with atopic dermatitis, treated with multiple topical steroids and antihistamines. The provider is requesting treatment with Dupixent. The patient has 10-15% (percent) body surface area (BSA) involved. The subject under review is the medical necessity for the requested Dupixent.

The health plan's determination is upheld.

The requested treatment with Dupixent is not medically necessary for this patient. According to the recommendations provided by Simpson, et al (2017), steps taken before commencing systemic therapy include considering alternate or concomitant diagnoses, avoiding trigger factors, optimizing topical therapy, ensuring adequate patient/caregiver education, treating coexistent infection, assessing the impact on quality of life, and considering phototherapy.

The plan alternatives which include tacrolimus ointment, cyclosporine capsules, azathioprine, or methotrexate and phototherapy are within the standard of care and a trial of these would be appropriate before Dupixent.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Asthma
Treatment: Fasenra
The insurer denied Fasenra.
The health plan's determination is upheld.

The patient is a female with a medical history of severe persistent eosinophilic asthma previously uncontrolled despite high dose inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) use with Breo Ellipta, Singulair and Albuterol. 

A formulary exception is not indicated. The patient does not have allergic asthma or an elevated IgE (immunoglobulin E) and therefore the patient would not be a candidate for Xolair.

Interleukin (IL)-5 is a pro-eosinophilic cytokine that is a potent mediator of eosinophil hematopoiesis and contributes to eosinophilic inflammation in the airways. Nucala is an anti-IL-5 monoclonal antibodies; Fasenra is an anti-IL-5 receptor alpha antibody. Both are Food and Drug Administration (FDA) approved for the treatment of moderate-to-severe eosinophilic asthma. Per the clinical documentation provided, the patient has not previously tried Nucala. There is no literature to support (Pubmed, Google Scholar) the use of the Fasenra as being superior to the formulary alternative. Therefore, without having tried or failed the formulary alternatives, a formulary exception is not indicated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ulcerative Pancolitis
Treatment: Stelara 90MG/ML SC SOSY (milligrams/milliliter/subcutaneous/solution prefilled syringe) every 4 weeks.
The health plan denied the Stelara 90MG/ML SC SOSY every 4 weeks.
The health plan's determination is upheld.

This patient is a male. He has a history of ulcerative colitis (UC). He has tried and failed numerous therapies, including Mesalamine, Infliximab and Entyvio. The patient was then started on Stelara and received the first induction (intravenous) dose.
The requested service is continuation of Stelara at 90 mg (milligrams) every 4 weeks.

I uphold, in whole, the health plan's determination of medical necessity.

Stelara is approved by the Food and Drug Administration (FDA) for treating ulcerative colitis in adults. The safety and efficacy of Stelara are well established. Despite the lack of FDA approval for pediatric patients, there are many peer reviewed publications supporting the efficacy and safety of Stelara in children with refractory inflammatory bowel disease.
A report by Dayan JR et al, showed that ustekinumab (Stelara) is efficacious and safe in pediatric patients with inflammatory bowel disease.
According to Dhaliwal, Jasbir, et al: "Ustekinumab demonstrated efficacy in this paediatric cohort with otherwise treatment-refractory UC."
Therefore, the use of Stelara is appropriate in this case with refractory ulcerative colitis.
However, the standard of care is to start Stelara at the FDA approved dosing regimen, 90 mg every 8 weeks. If the standard dose is deemed ineffective, then dose escalation is appropriate.
According to Dalal, R., et al: "UST (Stelara) dose escalation resulted in clinical remission in > (greater than) 50% (percent) of UC patients and was more effective in those with loss of response compared to no/minimal response after induction. "
This patient has a history of refractory ulcerative colitis and has failed anti-tumor necrosis factor alpha and conventional therapy. However, the patient has not tried and failed to respond to Stelara at the standard dose (90 mg every 8 weeks). He only received the first induction dose. There is no evidence that the standard dose of Stelara will not be effective in this case.
Therefore, escalation of Stelara to 90 mg every 4 weeks is not medically necessary at this time.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Shortness of Breath and Chest Pain
Treatment: Inpatient admission
The insurer denied the inpatient admission
The denial is upheld

The patient is a female. She was hospitalized for shortness of breath and chest pain x 1 week. The clinical impression was new-onset heart failure. Her PMH (past medical history) is pertinent for HTN (hypertension), atrial fibrillation, DM2 (diabetes mellitus) and MG (myasthenia gravis).

The patient's vital signs revealed the following: BP (blood pressure) elevated to 177/112, HR (heart rate) 106, RR (respiration rate) 18 and O2 (oxygen) saturation 98% on RA (room air). Respirations were even and non-labored. Lungs were diminished at the bases. Pro-BNP (prohormone brain natriuretic peptide) was elevated to 4780. Her treatment included IV (intravenous) Lasix 40 mg (milligrams) x 1 dose and BiPAP (bi-level positive airway pressure). Chest CTA (Computed Tomographic Angiography) was negative for PE (pulmonary embolism) and showed a left pleural effusion. She felt improved and left AMA (against medical advice).

This is an appeal of the denied claim the requested Acute Inpatient Hospital Stay was medically necessary for this patient.

No, the Inpatient admission was not medically necessary.
Based on the peer reviewed medical literature and this reviewer's expert medical opinion, the documentation submitted for review does not establish the requested Acute Inpatient Hospital Stay was medically necessary for this patient. According to the MCG (Milliman Care Guidelines) Guidelines titled: Heart Failure (ORG: M-190), Hypertension (ORG: M-197) and Cardiology GRG, the inpatient admission was not medically necessary. The severity of this patient's illness did not meet the intensity of service for inpatient hospital stay per the guidelines. Criteria for inpatient stay are not met, including documentation of hemodynamic instability, respiratory distress, change in mental status, severe heart failure, cardiac arrhythmias of immediate concern, myocardial ischemia or myocardial infarction, positive troponin not explained by CKD (chronic kidney disease) and CHF (congestive heart failure), hypertension requiring inpatient hospitalization, CVA (cerebrovascular accident), pulmonary embolism, aortic dissection, pneumonia, severe electrolyte abnormalities or any other medical condition or other medical instability or acute care needs for which emergency and observation care have failed or are not considered appropriate and that would require acute inpatient management. There was no clinical decline or inadequate response to treatment which required continuation of the hospital stay past the observation period. The care she received is routinely provided safely and effectively at a lower level of care. Therefore, the Inpatient admission was not medically necessary, based on the submitted information and the current published evidence-based guidelines.

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Pancreatitis.
Treatment: Abdomen MRI (magnetic resonance imaging).
The insurer denied the abdomen MRI (magnetic resonance imaging). 
The denial is upheld.

The patient is a male. He had an endoscopic ultrasound with changes consistent with chronic pancreatitis.  CTA (Computed Tomographic Angiography) chest / abdomen / pelvis showed no pancreatic abnormalities. The request is for MRI (magnetic resonance imaging) of the abdomen.

The appeal letter indicates that a follow-up MRI (magnetic resonance imaging) is needed to evaluate the pancreas.

No, the requested abdomen magnetic resonance imaging is not medically necessary.
The appeal letter indicates that a follow-up MRI (magnetic resonance imaging) is needed to evaluate the pancreas. However, there was no further information provided detailing as to what information the provider was hoping to learn. The patient had a CT (computed tomography) scan which showed a normal pancreas and therefore ruling out any abnormalities such as pancreatic mass or acute pancreatitis.

MRI (magnetic resonance imaging) pancreas may be utilized in establishing the diagnosis of chronic pancreatitis. However, the patient is not described as having signs / symptoms of chronic pancreatitis. The provider did not specifically state that chronic pancreatitis was being ruled out. Finally, the endoscopic ultrasound already established a diagnosis of chronic pancreatitis.

The requested abdomen magnetic resonance imaging is therefore not medically necessary.

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Failure to Thrive

Treatment long-term care

The insurer denied coverage for long-term care

The denial is upheld

This is a patient with history of failure to thrive, deep vein thrombosis (DVT), recurrent hypoglycemia, opioid dependence, and congestive heart failure (CHF). Of note, her ongoing weight loss from 93.5 pounds (lbs.) to 86.5 lbs. within 30 days despite a good appetite and consumption of over 75% (percent) of her meals. Under review is the medical necessity for long-term care.

According to the clinical records, the patient reportedly has been a resident at the facility. The primary condition being monitored at the facility is her nutritional status. She is "maintained on a regular diet with regular texture and thin liquids without signs of GI (gastrointestinal) intolerance or chewing/swallowing difficulty. Resident with good appetite and PO (oral) intake." There were no specific rehabilitation needs that required long-term care. In addition, there were no acute medical or complicated nursing issues that required continued stay for the time period under review. Ongoing care, particularly for nutritional management could have been provided via home care or as an outpatient.

The healthcare plan acted reasonably, with sound medical judgment and in the best interest of the patient. (Taken into consideration were the clinical standards of the plan, information provided concerning the patient, the attending physician's recommendation and applicable generally accepted practice guidelines developed by the federal government, national or professional medical society, board and associations. All decisions are evidence-based).

From a physical medicine and rehabilitation perspective, as well as within a reasonable degree of medical certainty, long-term care is not medically necessary.

The insurer's denial of coverage for long-term care is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Foot pain; blistering
Treatment: Inpatient admission
The insurer denied the inpatient admission
The denial is upheld

The patient is a female. She has history of diabetes, hypertension, and chronic kidney disease. She presented with left foot pain and blistering due to left foot cellulitis secondary to ulcer and hyperglycemia.

The patient's Glucose was 478 mg/dL (milligrams per deciliter), CO2 (carbon dioxide) 21, pH (potential of hydrogen) 7.31, creatinine 1.68. Her heart rate was 112, and blood pressure 173/109.

The patient was evaluated by vascular surgery and no intervention was recommended. Left foot x-ray was negative. Podiatry recommended oral antibiotics. The patient was started on Lantus insulin. The request for inpatient admission is under review.

No, the inpatient stay was not medically necessary.
This patient with type 2 diabetes and chronic kidney disease presented with hyperglycemia and left foot pain and blistering. She was diagnosed with left foot cellulitis with diabetic ulcer. She was evaluated by podiatry, who recommended oral antibiotics. She was evaluated by vascular surgery, who recommend no surgical intervention. The patient had hyperglycemia that was treated with subcutaneous insulin therapy. The patient was hypertensive and tachycardic, which resolved. The patient was hemodynamically stable. The patient refused Percocet due to history of nausea and vomiting. Other oral narcotics were not attempted. The patient had an elevated creatinine in the setting of losartan use and improved over time. Therefore, no, the inpatient stay was not medically necessary.

Yes, the health plan did act reasonably, with sound medical judgment and in the best interest of the patient
The requested inpatient stay was not medically necessary and was appropriately denied.