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

Diagnosis: Bipolar Disorder.
Treatment:  Latuda 20mg OR TABS, Pre-service.
The insurer denied the  Latuda 20mg OR TABS, Pre-service.
The denial is upheld.

This case involves an adult female diagnosed with a mood disorder best characterized as bipolar mood disorder with most recent episode depressed phase with major depressive disorder and suicidal ideation and concern with impulse control. She has reportedly received treatments with aripiprazole and quetiapine and Saphris, as well as treatment with risperidone while in the hospital without benefit/treatment failure or adverse effects according to the prescribing clinician. The patient has rejected the use of risperidone and olanzapine due to concern for weight gain, and the prescribing clinician references the barrier of needing an electrocardiogram (EKG) and QT prolongation that excludes ziprasidone from consideration.  The patient is receptive to the use of Latuda because her sister had a positive response to that medication. There is no reported substance use disorders or psychiatric comorbidity in this case. Submitted records indicate the use of lithium, lamotrigine and citalopram, as well as clonazepam.

No, the proposed treatment, Latuda 20 milligrams (MG) OR TABS, is not medically necessary.
Latuda is one of five Food and Drug Administration (FDA) approved medications for bipolar depression that includes olanzapine/fluoxetine; quetiapine; cariprazine and ziprasidone, as well as Latuda (lurasidone); and is clearly indicated for bipolar mood disorder. However, the requested benefit of Latuda (lurasidone) to treat bipolar mood disorder and depressive disorder should be excluded from coverage in this case. As the health plan asserts, there is no documentation or evidence that the requested medication is more effective than alternative agents on formulary, or that the requested medication would have a lower likelihood of an adverse effect compared to formulary alternatives. Formulary alternatives are outlined in the clinical summary.

Yes, the health plan did act reasonably, with sound medical judgment and in the best interest of the patient.
As the health plan asserts, there is no documentation or evidence that the requested medication is more effective than alternative agents on formulary, or that the requested medication would have a lower likelihood of an adverse effect compared to formulary alternatives. Formulary alternatives are outlined in the clinical summary and are reasonable in this case scenario.

This answer is consistent with the guidelines and scientific literature, referenced below, and is in keeping with the New York State instruction for this review and pertaining to coverage exceptions.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Lumbar Radiculopathy.

Treatment Oxycontin 10 mg (milligrams) tablet.

The insurer denied coverage for Oxycontin 10 mg tablet.

The denial is overturned.

This adult patient has lumbar radiculopathy. An electromyography revealed right L (lumbar) 4-5 radiculopathy with no evidence of peripheral neuropathy. He is followed by Pain Management. At an office visit, he was seen for complaints of lower back pain, rated as 8 out of 10 at that time. The patient had been undergoing steroid injections for pain control with effects lasting 2-3 weeks. He had been instructed to perform home exercises and was taking hydromorphone, Oxycontin extended release (ER), and Lyrica. The physician documented that the patient has tried and failed to respond adequately to Neurontin, Percocet, MS (morphine sulfate) Contin ER, Tramadol HCL (hydrochloride), Oxycodone HCL, Zanaflex, and morphine sulfate ER. The patient has opioid tolerance, opioid dependence, and is stable in his current medication regimen. The plan was for hydromorphone 8 mg (milligram) three times per day, Oxycontin ER 10 mg twice per day, and Lyrica 150 mg twice per day. Morphine and Tramadol had been trialed and failed.

Methadone has been associated with a large number of respiratory depression incidents due to the wide variation in metabolism (1). This patient is also taking Lyrica which interacts with Methadone (2).

The patient has trialed several preferred medications (Tramadol and Morphine) without benefit. The use of long duration medications such as Methadone or transdermal Fentanyl carries a substantial risk of adverse reactions.

The patient is stable on Hydromorphone and Oxycodone ER. The continuation of Oxycontin is medically reasonable and necessary.

The health care plan did not act reasonably, with sound medical judgement or in the best interest of the patient.

The insurer's denial of coverage for Oxycontin 10 mg (milligram) tablet is overturned. Medical necessity is substantiated
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: low back pain.
Treatment: Intracept procedure.
The insurer denied the Intracept procedure. 
The health plan's determination is upheld. 

The patient is a male with chronic lower back pain (LBP) for > (greater than) 5 years causing significant impact on his activities of daily living (ADL). PMHX (past medical history) has included hypertension (HTN), and hyperlipidemia. He was taking Valsartan, Vytorin and Androgel. The pain was describe as worse with standing and walking. The patient used nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, chiropractor care, and multiple radiofrequency ablations (RFAs) resulting in 70% relief lasting 6 months. The review of symptoms was noncontributory. Physical examination did not document limitations of axial skeleton movement. Pertinent magnetic resonance imaging (MRI) findings include multiple areas in the lumbar spine including disc bulge, narrowing of bilateral neural foraminal spaces, facet arthropathy, spinal stenosis at L (lumbar)3-4, 4-5, 5-S (sacral)1 and spondylolisthesis. The pain physician noted Modic at L3-5 changes although this was not included in the MRI report. He was subsequently diagnosed with back pain emanating from a vertbrogenic etiology and consented for RFA L3-5.

The 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. The documentation in this case is limited and does not include what anatomic location the RFA occurred. The requesting physician notes that the patient's pain is significant and limits activities of daily living (ADL) but there is no ODI (Official Disability Index) score or specific explanation as to the degree of limitations. There is not documentation provided of moderate to severe disability and Modic changes on the magnetic resonance imaging (MRI) for this patient. Therefore, the Intracept procedure is not indicated for this patient at this time.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: low back pain.
Treatment: Intracept procedure.
The insurer denied the Intracept procedure. 
The health plan's determination is upheld. 

The patient is a male who has a long-standing history of low back pain. He had tried trigger points injections and non-steroidal anti-inflammatory drugs (NSAIDs) with no relief. Each of the prior radiofrequency ablations provided 6 to 8 month of pain relief. Physical exam (PE) was unremarkable according to the available medical records. An magnetic resonance imaging (MRI) showed facet arthropathy at L (lumbar) 3-4 L4-5 and L5-S1, disc bulge with severe spinal stenosis at L3-4, and anterolisthesis of L4 and L5.

The 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.
The Intracept system was designed to treat low back pain from vertebral body by ablating Basivertebral nerves. Reviewing of the available medical records did not reveal adequate evidence that this patient's pain is from vertebral bodies. This patient responded to prior radiofrequency ablations with 6 to 8 month of pain relief from each of ablations, which indicated lumbar facet arthropathy is a significant pain generator. MRI revealed multilevel disc bulges, facet joint arthropathy, and severe spinal stenosis. Truumees's study supported the efficacy of Intracept procedure. However, the patients with radiographic evidence of other pain etiologies including disc bulge and facet arthrosis were excluded.
Given this patient's medical history, MRI reading, and the current clinical evidence, he is not an appropriate candidate for this Intracept procedure. The proposed Intracept Procedure is unlikely to be more beneficial than any standard treatment for this patient's back pain.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: low back pain.
Treatment: Intracept procedure.
The insurer denied the Intracept procedure. 
The health plan's determination is upheld. 

The patient is a male with low back pain. An magnetic resonance imaging (MRI) L (lumbar) spine reported multilevel degenerative changes. The patient has undergone a prior radiofrequency ablation (RFA). He has undergone prior injections. Physical exam demonstrated average build, no hair or nail changes, and cranial nerves intact. There is a request for the Intracept procedure.

The 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. The patient has complaints of low back pain. This procedure is not recommended. Despite promising early reports, further trials with longer-term outcomes and less risk of bias are required for the Intracept procedure. An 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.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Suspected Infection. 
Treatment: Full Hospital Admission. 

The insurer denied coverage for full hospital admission. 

The denial is upheld. 

This adult patient presented with fever and shortness of breath (SOB). In the emergency department (ED), she had a pulse of 130 but it had improved by the time of admission. The oxygen saturation was 99% (percent) on room air. The chest exam was clear. Chest CTA (computed tomography angiography) did not find a pulmonary embolism. There was elevation of the liver enzymes. The INR (International Normalized Ratio) was 1.26. There was no leukocytosis. An abdominal ultrasound was negative for cholecystitis. There was a concern that the patient had a tick-borne illness and Doxycycline was started. The patient was admitted for further evaluation. She was discharged with outpatient follow-up planned. 

Clinical indications for admission for Liver Disease Complications (MCG (Milliman Care Guidelines) M-570) include hepatic encephalopathy, hemodynamic instability, tachypnea that persists after observation care, infected ascites, a severe coagulopathy, severe vomiting, severe dehydration, and acute liver necrosis. The patient did not have these conditions. 

This patient had a suspected infection that required treatment with Doxycycline. She had elevated liver enzymes but did not have evidence of acute liver failure. She continued to have a mild tachycardia but was hemodynamically stable. She was stable enough to have been treated with the Doxycycline as an outpatient once the chest computerized tomography angiography (CTA) was negative. She did not meet MCG (Milliman Care Guideline) criteria for admission for liver disease complications. She could have been managed with observation status. An inpatient admission was not medically necessary. 

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

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

Diagnosis: Low back pain.
Treatment: Lumbar spine MRI.
The insurer denied the Lumbar spine MRI.
The determination is upheld.

The patient has a history of chronic low back pain, left shoulder pain, thyroid nodule, opioid dependence, nicotine abuse, Vitamin D deficiency, numbness/tingling in the bilateral hands, and post-traumatic stress disorder (PTSD). She is requesting coverage for an MRI of the lumbar spine. A magnetic resonance imaging (MRI) of the lower back, but there are no contemporaneous medical records documenting an evaluation of this problem. She presented to her primary care provider to inquire as to why the lumbar spine MRI was not approved. The patient reported getting physical therapy for her neck and shoulder pains. The patient reported limited benefit from Suboxone, ibuprofen, and acetaminophen, although it is not clear if she was referring to her neck and shoulder pains or her low back pain. There was no history of lower extremity radicular symptoms, and there were no lower extremity neurologic findings. Lumbar spine plain films and a referral for physical therapy were noted in the plans, but there are no further records documenting the imaging results or physical therapy visits. In no visits were lower extremity radicular complaints, lower extremity neurologic findings, or any other worrisome findings documented.
At issue is the medical necessity of a lumbar spine MRI.
The requested health service/treatment of Lumbar Spine MRI was not medically necessary for this patient. Based on a review of the information provided, the medical necessity of the lumbar spine MRI cannot be substantiated. An MRI of the lumbar spine is indicated for low back pain when there are radicular symptoms as well as objective evidence of a radiculopathy that persists despite six weeks of appropriate provider guided therapy. In addition, an MRI of the lumbar spine is indicated for clear evidence of spinal stenosis, suspicion for spinal cord compression, follow up for recent spinal surgery, evaluating for malignancy, infection, fractures, or myelopathy. In this case, the patient does not meet any of these criteria. Chronic low back pain, in and of itself, is not an indication for an MRI. Therefore, based on the standard of care, and the peer reviewed literature cited in the references, the MRI of the lumbar spine was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest Pain

Treatment inpatient admission stay

The insurer denied coverage for inpatient admission stay.

The denial is upheld.

This is the case of a male that presented to the hospital following an assault. He noted head, neck, and chest pain. Past medical history was significant for hypertension and diabetes mellitus. Upon arrival, vital signs were stable with blood pressure (BP) 151/83 and pulse 62 beats per minute. Physical exam was significant for epigastric tenderness, cervical spine tenderness and abrasions of both knees.  12 lead electrocardiogram revealed normal sinus rhythm with nonspecific T (interval on EKG (electrocardiogram) wave changes. Serum creatine phosphokinase (CPK) was 425mg/dl (milligram per deciliter) and serum troponin was not elevated (0.025ng/ml [nanogram per milliliter]). The patient was admitted to the telemetry unit for observation and treatment. Chest pain was noted to be secondary to trauma and was reproducible. Imaging studies did not reveal fracture or organ abnormalities and the patient was discharged the following day. 

This patient presented with atypical chest pain and a past medical history of hypertension and diabetes mellitus. His pretest probability of coronary artery disease was low (1). Utilizing the HEART (History, EKG, Age, Risk factors, and Troponin) score she was considered low risk (2). Utilizing the TIMI (Thrombolysis in Myocardial Infarction) risk score he also had a low risk of developing major adverse cardiac events in the subsequent 30 days (3). Risk assessment of patients presenting with chest pain and no significant ST (interval on EKG) changes on EKG was reviewed by Hedayati et al. (3) Using the HEART score risk stratification schema, this patient would have a low risk of major adverse cardiac events (defined as myocardial infarction (MI), need for percutaneous coronary intervention (PCI), need for coronary artery bypass grafting (CABG), or death) in the six weeks following presentation.  

This patient had chest pain due to blunt trauma following an assault. Patients with blunt chest trauma suspected of cardiac contusion with nonspecific electrocardiographic findings and no evidence of hypotension require no further work up (4). In conclusion, admission to the hospital to treat an acute cardiac event or cardiac contusion was not medically necessary. This patient could have been treated at a lower level of care.

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

The insurer's denial of coverage for the inpatient admission is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cystic Fibrosis
Treatment: Volara System

The insurer denied coverage for Volara System.
The denial is upheld.

The patient is an adult female with history of cystic fibrosis. The patient has advanced lung disease with chronic respiratory failure. The Volara System was prescribed by her treating physician. The prescription indicated that the patient had tried and failed high frequency chest wall oscillation.

In a Cochrane study involving 39 studies they reported that, "There was no clear evidence that oscillation was a more or less effective intervention overall than other forms of physiotherapy; furthermore, there was no evidence that one device is superior to another. The findings from one study showing an increase in frequency of exacerbations requiring antibiotics whilst using an oscillating device compared to positive expiratory pressure may have significant resource implications. More adequately-powered long-term randomized controlled trials are necessary and outcomes measured should include frequency of exacerbations, individual preference, adherence to therapy and general satisfaction with treatment. Increased adherence to therapy may then lead to improvements in other parameters, such as exercise tolerance and respiratory function. Additional evidence is needed to evaluate whether oscillating devices combined with other forms of airway clearance is efficacious in people with cystic fibrosis."

In a study of Cochrane Reviews by Wilson et al, they concluded that, "There is little evidence to support the use of one airway clearance technique over another. People with cystic fibrosis should choose the airway clearance technique that best meets their needs, after considering comfort, convenience, flexibility, practicality, cost, or some other factor. More long-term, high-quality randomized controlled trials comparing airway clearance techniques among people with cystic fibrosis are needed."

As per the physician notes the patient also had a recent Rhinovirus infection which caused wheezing. The patient complained of some cough and wheezing at the visit. The patient's medications included Albuterol, Hypertonic Saline, Pulmozyme, and Breo inhalers. She was also prescribed Aztreonam Solution for Nebulized Rx as recent Sputum culture and sensitivity (C/S) grew Pseudomonas. Treatments included chest physiotherapy and Vest.

The patient's physician prescribed the Volara system for her. This is essentially a conical positive expiratory pressure (CPEP) and continuous high-frequency oscillation (CHFO) device with the ability to also deliver nebulized medications. The patient is already on high frequency chest wall oscillation (HFCWO) therapy with the vest. She does not need the Volara system. Based on above, the Volara System is not considered medically necessary for this patient.

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

The insurer's denial of coverage for a Volara System and circuits, codes A9999 and E1399 is upheld. Medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal. 
Treatment: Inpatient Hospital. 

The insurer denied inpatient stay. 
The denial is upheld. 

The patient is a male who underwent a planned elective forefoot reconstruction. The patient presented to the hospital with the diagnosis of right hallux valgus, metatarsus primus varus, metatarsalgia and a second hammertoe. He had several stable medical issues and was felt to be medically appropriate for surgery. The subject under review is the medical necessity for the inpatient stay. 

The health plan's determination is upheld. 

The inpatient stay is not medically necessary. The patient needed extra time in the facility to have a safe discharge, but this did not have to be at the inpatient level. He underwent a first tarsometatarsal fusion, distal soft tissue correction and a proximal phalangeal osteotomy. His lesser toes were also corrected during the procedure. 

Clinical notes describe an uneventful surgery without complications. His post-operative course was also described as uneventful, and he had no exacerbation of his co-morbid conditions. He required several days in the hospital for pain control and safe mobilization; however, this did not require an inpatient stay. The patient could have been treated at a lower level of care status.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dental decay, missing teeth.
Treatment:Implant Placement (D6010) Teeth #s 3, 5, 6, 8, 9, 11, 12, 14, 22, 25, 27, and 30.
The insurer denied the Implant Placement (D6010) Teeth #s 3, 5, 6, 8, 9, 11, 12, 14, 22, 25, 27, and 30.
The denial is upheld.

The patient is a male.  This patient suffered a baseball bat to the jaws early in life causing jaw fractures and loss of teeth. At this time, the patient is under the care of a dentist, oral maxillofacial surgeon (OMS), and physician. The patient is being treated for anxiety and depression. The doctor mentions that the patient has speech and nutrition issues. The patient has been diagnosed with dental decay with many decayed, missing, non-restorable teeth. The records mention the patient has a gag reflex. The dentition has been diagnosed as failing and a recommended treatment plan was proposed to include removal of all teeth, bilateral sinus lifts with grafts, and eight maxillary and six mandibular implant placement.

No, the proposed treatment is not medically necessary.
The records do not support medical necessity for the proposed treatment. There is no evidence to support the attempt to salvage the current dentition. There is no evidence of any attempt at removal prostheses. There is no evidence provided that this patient's current dentition is nonrestorable.

Yes, the health plan acted reasonably in this decision.
The decision was based on all the information provided for review from the health plan, dentist, oral maxillofacial surgeon (OMS), physician, and legal services.