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

Diagnosis: Orthopedic/Musculoskeletal 
Treatment: Surgical Services - Intracept procedure 
The insurer denied Intracept procedure as experimental/investigational. 
The denial is overturned.

This patient is a female who has a long-standing history of low back pain. Her pain level is rated at 7/10. Her pain is localized in the lower back, which she describes as dull and achy. She had a lumbar epidural injection with no relief. Her pain is causing significant functional limitation with sleep disturbance. She had other treatments including physical therapy (PT) and pain medications without success. Her physical exam (PE) was remarkable for tenderness to palpation in lumbar paraspinal region.

The magnetic resonance imaging (MRI) scan showed degenerative disc disease at lumbar (L) 4-5 level and severe degenerative disc disease with degenerative end plate changes at L5 - sacral (S) 1 level. This patient was recommended to have the Intracept procedure at L5 and S1 levels.

At issue is whether the proposed health service or treatment Intracept procedure is likely to be more beneficial than any standard treatment or treatments for the patient's condition.

The health plan's determination regarding the proposed health service or treatment is overturned in whole.

The proposed health service or treatment Intracept procedure is likely to be more beneficial than any standard treatments for the patient's medical condition.

The Intracept system was designed to treat low back pain from vertebral body by ablating intraosseous nerves. There are multiple clinical trials demonstrated the efficacy of this intervention. This patient has persistent back pain consistent with L5-S1 end plate degenerative changes. She had tried conservative treatments including pain medications and PT. She is an appropriate candidate for this procedure. She has severe pain with significant functional impairment. Further interventions are medically necessary to improve her pain and functional level. Other potential treatment options such as long-term use of medications including opioids and lumbar fusion surgery have a high success rate, but all of these carry more risks and complications. Given this clinical scenario, Intracept is the appropriate next step intervention.

Therefore, the proposed health service or treatment Intracept procedure is likely to be more beneficial than any standard treatments for the patient's medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal 
Treatment: Surgical Services - Intracept procedure 
The insurer denied Intracept procedure as experimental/investigational. 
The denial is upheld.

The patient is a female with complaints of low back pain. The magnetic resonance imaging (MRI) scan of the lumbar spine demonstrated degenerative disc disease and degenerative endplate changes predominantly involving the lumbar (L) 5- sacral (S) 1 levels. The patient is noted to have ongoing low back pain following interlaminar epidural injection. Her pain is rated an 8 out of 10. She has trialed multiple medications, and currently utilizes ibuprofen. The physical exam demonstrated positive tenderness to palpation over lumbar erector spinae with persistent muscle spasms and trigger points. There was a recommendation for the Intracept procedure by her provider.

At issue is whether the proposed health service or treatment Intracept procedure is likely to be more beneficial than any standard treatment or treatments for the patient's condition.

The health plan's determination regarding the proposed health service or treatment is upheld in whole.

The proposed health service or treatment Intracept procedure is not likely to be more beneficial than any standard treatment or treatments for the patient's life threatening or disabling condition or disease.

This patient has complaints of low back pain. There is a request for Intracept procedure or intraosseous basivertebral nerve ablation. Despite promising early reports, further trials with longer-term outcomes and less risk of bias are required. A United States 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 a treatment modality. In general, there is a lack of substantial support for this procedure, and it is currently not considered the standard of care.

Given this, the proposed health service or treatment Intracept procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal 
Treatment: Surgical Services - Intracept procedure
The insurer denied Intracept procedure as experimental/investigational. 
The denial is upheld. 

This is a female patient diagnosed with lumbar spondylosis without myelopathy or radiculopathy. A magnetic resonance imaging (MRI) scan of the lumbar spine revealed degenerative disc disease and degenerative endplate changes predominantly involving the L (lumbar) 5-S (sacral) 1 level. No herniation or nerve impingement was identified.
At issue is whether the proposed health service or treatment Intracept procedure likely to be more beneficial than any standard treatment for the patient's condition.

The health plan's determination regarding the proposed health service or treatment is upheld in whole.

The proposed health service or treatment Intracept procedure is not likely to be more beneficial than any standard treatment for the patient's condition.

The International Society for the Advancement of Spine Surgery's guideline on "Intraosseous ablation of the basivertebral nerve for the relief of chronic low back pain" (Lorio, et al, 2020) stated that "intraosseous ablation of the basivertebral nerve (BVN) is a new procedure; its limitations included industry funding is a potential source of study bias for the available data reviewed, limited number of studies, short-term follow-up for the majority of studied patients, and unknown effect on the primary degenerative process."

Per Fischgrund, et al, "Patients treated with radiofrequency (RF) ablation of the BVN for chronic low back pain (CLBP) exhibited significantly greater improvement in Oswestry Disability Index (ODI) at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain." There appears to be positive initial results, however, the study was fairly small and there continues to be a lack of long-term studies evaluating long term risks/benefits when compared to other standard means of treatment and further large, high-quality studies are needed.

Additional studies are needed to evaluate long-term risks and benefits of this procedure.
Therefore, the proposed health service or treatment Intracept procedure is not likely to be more beneficial than any standard treatment or treatments for the patient's life threatening or disabling condition or disease.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hyponatremia.
Treatment: Inpatient stay.

The insurer denied the inpatient stay. The health plan's determination is overturned.

This is male with a chronic history of right knee pain that has been progressive. The medical history includes hypertension and situational anxiety. The patient underwent right total knee arthroplasty. The patient was in the operating room for almost 3 hours. After surgery, the patient was transferred to the post anesthesia care unit for intensive monitoring until he was stable for transfer to a nursing floor. The patient received intravenous lactated ringers at 30-75 cubic centimeters per hour for repletion. Neurovascular/department checks were performed every four hours due to the neuraxial block used for the surgery. The patient rated his pain at 4-8/10. He was treated with Ofirmev, Tylenol, Toradol, Dilaudid, and oxycodone for pain management. The letter indicates the patient's blood pressure was elevated at 180/104, 194/101, and 176/97. The elevated blood pressure was treated with intravenous locatable 10 mg (milligrams). The patient was noted to have hyponatremia with sodium trending down from 130 to 128 to 123 to 121. The renal service was consulted. The patient made greater than 2 L (liters) of urine in the prior 12 hours with evidence of delusional urine, and the hyponatremia was felt to be likely related to increased free water intake in the setting of impaired free water excretion. The patient was placed on strict ins and outs with daily weights, fluid restriction of 1 L per day, and sodium repletion. Norvasc was given for elevated blood pressures. 

The inpatient hospital admission was medically necessary for this patient given the significant hyponatremia and hypertension.

The provided documentation indicates the patient underwent elective total knee arthroplasty. He had significant hypertension postoperatively with blood pressure elevated at 180/104, 194/101, and 176/97. The Hypertension persisted despite intravenous labetalol and oral Norvasc. Additionally, the patient was noted to have hyponatremia with sodium trending down from 130 to 128 to 123 to 121. The patient was changed to inpatient status. He had persistent hypertension and hyponatremia  requiring further evaluation and treatment. The patient was subsequently deemed stable for discharge.

As noted in the referenced article from StatPearls, if left untreated or inadequately treated, a patient with hyponatremia can develop rhabdomyolysis, altered mental status, seizures, and coma. Given the declining sodium approaching severe hyponatremia, the change in status to inpatient was appropriate to monitor and manage the hyponatremia. Additionally, the change in status to inpatient was appropriate to monitor and manage the hypertensive urgency in order to prevent progression to hypertensive emergency/organ damage.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Diabetes and Hyperglycemia
Treatment: Inpatient Hospital
The health plan denied the requested inpatient stay as not medically necessary. The health plan's determination is overturned.

This is a female with a history of alcohol abuse complicated with chronic diverticulitis, and diabetes type 2, who presented with epigastric pain associated with nausea and vomiting. On examination, she was tachycardic, and labs on admission revealed dehydration/azotemia, hyponatremia, hypokalemia, acid-base disturbance with lactic acidemia, acute blood loss anemia, and thrombocytopenia. She was admitted to the inpatient floor and received intravenous (IV) fluids with electrolyte and acid-base correction, subcutaneous insulin injection for hyperglycemia, and underwent an alcohol detoxification/alcohol withdrawal regimen. She was started on an IV acid suppression, alcoholic gastritis, and IV antiemetics. She underwent serial electrolytes monitoring. The patient was discharged home after her dehydration was resolved with IV fluids, correction of electrolytes and tolerating an oral intake.

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

Inpatient care was necessary for this female with a history of diabetes and alcohol abuse who was admitted for acid-base disturbance characterized by ketoacidosis and electrolyte derangement secondary to the multifactorial process of hyperglycemia from untreated diabetes and excessive alcohol intake. Her clinical presentation of dehydration, ketoacidosis, electrolyte derangements, and hematologic derangements required aggressive inpatient care such as IV fluids with electrolyte correction, serial labs to measure acid-base disturbance, and IV antiemetics and endocrine and a CATCH consult (adult psychiatric consultation). Therefore, it is prudent to initiate inpatient care in this patient with a high risk of complications of alcohol abuse complicated with electrolyte derangement and acid-base disturbance to prevent increased mortality and morbidity.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Sickle Cell Pain Crisis.
Treatment: Inpatient Hospital Stay.
The insurer denied the Inpatient Hospital Stay.
The determination is upheld.

The patient has a history of sickle cell disease. He presented for care with back pain and chest pain that failed treatment with Tylenol and Motrin at home. He was found to have a blood pressure of 95/58, and his initial hemoglobin level was 8.1 grams per deciliter (g/dL) with a reticulocyte count of 11.44%. He was given intravenous (IV) fluids, Toradol, Ofirmev and morphine. He continued to have 5/10 level of back and chest pain so he was admitted for further treatment and monitoring. After admission he was given further IV fluids, and morphine was ordered around the clock every 4 hours with every 2 hour dosing for breakthrough pain. His back pain level decreased to 1-2/10 and he had no shortness of breath or chest pain. He was transitioned to oral pain medications and was discharged home later that day. The acute inpatient level of care from is under review for medical necessity.
The requested health service/treatment of inpatient stay was not medically necessary for this patient as the patient's care needs could have been safely provided at a lower level of care.
This patient was admitted for treatment of a sickle cell disease pain crisis. As per the Milliman Care Guidelines (MCG) 24th Edition: Sickle Cell Disease, admission is indicated for certain specific clinical concerns. It may be necessary for stroke, seizure, posterior reversible encephalopathy syndrome, or other central nervous system symptom or event, for acute chest syndrome, hypoxemia, need for emergent surgery, acute ischemia, acute renal failure, aplastic crisis, priapism or other vascular complication, traumatic hyphema, infection requiring inpatient treatment, altered mental status, inability to maintain hydration orally despite observation care treatment, or exchange transfusion. It may also be considered appropriate for treatment of pain insufficiently responsive to observation care treatment that requires treatment in the inpatient setting. While this patient had a need for frequent intravenous (IV) narcotic therapy, the patient had a 24-hour stay in the hospital that could have been safely met at a lower level of care. There were no complications related to his pain crisis, no documentation of acute chest pain, or other secondary issue. The care provided to this patient is consistent with the National Heart Lung Blood Institute guidelines for the management of sickle cell disease.
Therefore, based on the clinical information provided for review and the current standards of care, and peer-reviewed literature, this request for acute inpatient stay is not medically necessary at this time.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Hearing loss
Treatment: Cochlear implant
The insurer denied a cochlear implant.
The health plan's determination is overturned.

The patient is a male who was found to have severe left sensorineural hearing loss with normal hearing in the right ear confirmed on audiogram. He also failed his newborn hearing screen on the left.

The patient did not benefit from a soft band (conductive) hearing aid. The current treatment plan is to place a cochlear implant (CI) on the left.

A Cochlear Implant is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Standard treatment for unilateral deafness in infants is the use of a CROS (contralateral routing of signals) hearing aid or a bone conduction hearing aid.

The proposed treatment with a left Cochlear Implant is likely to be more beneficial than any standard treatment(s) for the patient's disabling condition. This is because the standard treatments work by routing sound from the deaf ear to the good ear, but do not directly stimulate the deaf ear. A cochlear implant does directly stimulate the cochlea and auditory processing centers on the deaf side. This leads to better sound processing by the child, improves the ability to hear in background noise, and improves sound localization.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Hearing loss
Treatment: Cochlear implant
The insurer denied a cochlear implant.
The health plan's determination is overturned.

The patient is a male with hearing loss. He has profound left-sided hearing loss. Right-sided hearing is normal. An magnetic resonance imaging (MRI) of brain was normal. A computed tomography (CT) scan of temporal bone was normal. A softband BAHA (bone anchored hearing aid) had been attempted. 

A Cochlear Implant is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The child has profound hearing loss. There is no other intervention which can provide normal hearing for this child. His hearing loss is too severe to obtain any benefit from a hearing aid. A CROS (contralateral routing of signals) hearing aid or bone anchored hearing aid does not provide normal hearing for the affected ear and does not allow for sound localization. A Cochlear Implant will provide the greatest opportunity for this child to develop normal speech and language development.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Hearing loss
Treatment: Cochlear implant
The insurer denied a cochlear implant.
The health plan's determination is overturned.

The patient is a male with sensorineural hearing loss in the left ear. The right ear has essentially normal hearing. The proper work up included a temporal bone computed tomography (CT) to rule out cochlear abnormalities and it was performed. The requesting surgeon recommended early implantation during the crucial stage of language acquisition (before age 5 years). Formal language testing also noted deficits in auditory skill development leading to communication pathology.

A Cochlear Implant is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The patient is at significant risk for language delay without treatment for the left-sided deafness. One option would be a CROS (contralateral routing of signals) hearing aid or a bone anchored hearing side. However, as this patient is still developing gross motor, behavioral, and language skills, there is concern that localization to the right ear (which is the only functioning ear) would prevent normal development. Without cochlear implantation, the patient's unilateral hearing loss would result in a more severe morbidity (language delay and sound localization).
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: flank pain
Treatment: Inpatient stay
The insurer denied the inpatient stay. The health plan's determination is upheld.

The patient is a man presenting to the emergency room (ER) with acute flank pain and fever 102.5. He was hypotensive with systolic blood pressure (BP) 86. He responded to fluids. Imaging revealed an 8 millimeter (mm) obstructing UPJ (Ureteropelvic junction) stone. He was given intravenous (IV) antibiotics. He was taken to the operating room (OR) for stent placement after admission. He was discharged with oral antibiotic the subsequent day.

The inpatient hospital admission was not medically necessary. The patient was afforded stent placement with IV antibiotics and fluid resuscitation. He responded well to treatment. He was discharged in stable condition not requiring additional hospital level of care. The patient was properly and promptly treated by the hospital staff and discharged the subsequent day; inpatient stay was not medically necessary. The patient could have been cared for at a lower level of care.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Persistent Atrial Fibrillation
Treatment: Formulary exception for Eliquis
The insurer denied the Formulary exception for Eliquis
The denial is overturned.

The patient is a male with persistent atrial fibrillation that requires anti-coagulation. Xarelto and warfarin were tried, but were not tolerated. Excessive bleeding and fluctuating proteins were  described.  Eliquis was requested but denied as off formulary.

Yes, the health plan should cover the Formulary exception for Eliquis.
Eliquis meets requirements of use. Anti-coagulation is a Class 1 indications in this setting. Formulary choices of warfarin and Xarelto were tried but not tolerated. Eliquis would be appropriate to the choice.

Recent published studies in respected journals, including New England Journal of Medicine and JAMA (Journal of the American Medical Association) have concluded that Eliquis is the preferred anticoagulant for this condition. Large population studies have shown that Eliquis is safer, less bleeding, less strokes, less complications than either Xarelto or warfarin.

Eliquis was found to be more effective than warfarin in lowering the risk of stroke and systemic embolism. People who took Eliquis also had significantly fewer bleeding episodes than those who took warfarin.

Eliquis is the only NOAC (non-vitamin K oral anticoagulant) that is better than warfarin in the prevention of stroke and results in fewer bleeding complications. Overall, all-cause mortality from DOACs (directly acting oral anticoagulants) are evidenced to be lower than that from warfarin, driven primarily by a decrease in fatal intracranial bleeding risks.

Among Medicare beneficiaries 65 years or older with atrial fibrillation, treatment with rivaroxaban compared with apixaban was associated with a significantly increased risk of major ischemic or hemorrhagic events.

Per published literature, "In conclusion, in patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality." (6)