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

Diagnosis: Breast wound (Breast Cancer). 
Treatment: Durable Medical Equipment (additional healthcare supplies -code A6253 x 288), Pre-service. 

The insurer denied the Durable Medical Equipment (additional healthcare supplies -code A6253 x 288), Pre-service. 

The denial is upheld. 

The patient is a female. The patient has been diagnosed with metastatic breast cancer.  She was initially diagnosed.  At that time, she was treated with palliative radiation followed by treatment with letrozole and Ibrance.  She was noted to have increased swelling and ulceration of the left breast, felt most likely due to cancer progression. She was treated with antibiotics for suspected infection and following that she developed multiple skin nodules along the left chest extending to the right side and left side of her back. She was treated with two doses of weekly paclitaxel, but due to poor IV (intravenous) access, that was changed to oral capecitabine. 

Records note that the patient was tolerating capecitabine well.  She was evidenced to be doing better, and her breast wounds were evidenced to be healing. 

The patient was seen for follow up, and she had no pain in her breasts. Physical examination did not document any ongoing breast wound in the left breast. There was no tenderness or mass in either breast.   However, in the assessment section she was noted to have continued but improving ulceration of the skin over both breasts.  She had been doing home wound care. At issue is wound care using special absorbent dressings, and specifically the prescription was written for a total of 378 units to be used over 90 days. 

No, the requested health service is not medically necessary. 

This patient has ulceration on the skin of both breasts. The ulceration has been improving.  Based on review of records, there is no clear indication of how extensive her skin involvement is at the present time. No specific information is provided regarding how many absorbent dressings she needs on a daily basis.  The prescription is written for 378 individual units and pads, each greater than 48 square inches.  Based on lack of specific documentation indicating why this many are necessary, this request cannot be considered medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Diabetes Mellitus Type 1 (E10.65) 
Treatment: Replacement Insulin Pump (E0784), Pre-service 

The insurer denied the  Replacement Insulin Pump (E0784), Pre-service. 
The denial is overturned. 

The patient is a male with type 1 diabetes on insulin pump therapy. His current insulin pump is out of warranty. His A1C (glycated hemoglobin) is 7.6%. The request for replacement insulin is under review. 

The new pump will have adjustable insulin with Bluetooth capabilities and will facilitate management with the patient and provider. He has a hypoglycemia unawareness and a history of severe hypoglycemia. The prior request was denied as the documentation does not indicate his current insulin pump is malfunctioning. 

Yes, the proposed replacement insulin pump is medically necessary. 

This patient's pump is out of warranty. The prior request for a replacement was denied as the patient's insulin pump is not malfunctioning. Waiting until his insulin pump malfunctions puts this patient at significant health risk. A malfunctioning insulin pump can cause life-threatening diabetic ketoacidosis or severe hypoglycemia. Obtaining a replacement insulin pump should not be delayed until the patient's pump is malfunctioning. This patient has been stable on insulin pump therapy, and his diabetes is complicated by hypoglycemia unawareness and a history of severe hypoglycemia. Going back to insulin injections would increase his risk of hypoglycemia and hyperglycemia, which can cause complications such as seizures, retinopathy, neuropathy, and nephropathy. Use of insulin pump therapy in this clinical situation is supported by the Endocrine Society guidelines [1] and the American Diabetes Association clinical guidelines [2]. Therefore, yes, the proposed replacement insulin pump is medically necessary. 

This patient is stable on insulin therapy, and a replacement pump should not be delayed until the pump is malfunctioning given the health risk. Therefore, no, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Neck and shoulder pain
Treatment: Anterior cervical discectomy and fusion procedure (ACDF)
The insurer denied the Anterior cervical discectomy and fusion procedure (ACDF).
The determination is upheld.

The patient has a diagnosis of non-small cell lung cancer with prior metastases to the brain who has undergone radiation and chemotherapy treatments, and the latter are ongoing. About 18 months ago, she developed neck pain and pain radiating down her left arm to the thumb, index and third finger. According to both the neurosurgeon's notes and the oncologist's notes, the patient has tried chiropractic therapy, cervical injections and 6 weeks of physical therapy, all without sustained relief. She is maintained on oral Dilaudid and takes oral steroids and gabapentin. She continues to smoke cigarettes, although she is working hard to wean off of them.

According to the neurological examination in the neurosurgery note, the patient has 5-/5 left triceps strength but preserved sensation.

An electromyogram (EMG) reported mild left cervical (C) 5-7 nerve irritation. A magnetic resonance imaging (MRI) scan of the cervical spine reported broad-based disc bulging C5-6 with moderate canal stenosis and severe left and moderate right neural foraminal stenosis. A brain MRI scan with and without contrast reported no evidence of metastatic disease.

The surgeon has recommended an ACDF (anterior cervical discectomy and fusion) procedure at C5-6 for the diagnosis of left C6 radiculopathy. This has been denied by the health plan because the patient is a current smoker and they require 6 weeks of smoking cessation before an ACDF. The medical necessity for this procedure in this patient at this time is the issue for this review.

The requested health service is not medically necessary for this patient at this time. This is an elective procedure for pain, not for progressive myelopathy or instability, so there is no clinical reason to waive the smoking cessation requirement. Nicotine use can have a negative impact on bone fusion leading to pseudarthrosis and the potential need for further surgery, as well as poorer patient clinical outcomes. There is also an associated risk of increased post-operative complications other than fusion failure, such as poor wound healing and risk of infection. (Purvis et al, Berman et al and Jackson et al)). According to Khurana et al, smoking impairs spinal tissue vascular supply, compromising all the tissues including disc, cartilage, synovium, bone and blood vessels, which "can lead to early surgery, delayed wound healing, increased surgical site infection, failed fusion, more re-operations and chronic spinal pain." While it is true that 1-level ACDF procedures have a high rate of successful fusion even in smokers (Luszczyk et al), as noted above it is not only the risk of pseudarthrosis that drives the recommendation for smoking cessation for spine surgical procedures.

Therefore, the requested procedure is not medically necessary at this time.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Inpatient Hospital. 

The insurer denied inpatient stay. 
The denial is upheld. 

The patient is a female who presented to the hospital emergency department (ED) with upper abdominal pain of 3-days duration. She has a past medical history of anxiety, post-traumatic stress disorder (PTSD), fibromyalgia, migraines and endometriosis. At the time of presentation, the patient was without fever and vital signs showed a heart rate of 69/min and blood pressure of 143/65 millimeters of mercury (mmHg). She was tender in the upper abdomen. The white blood cell (WBC) count was normal at 9.9 thousand (K.) The complete metabolic panel identified normal aspartate aminotransferase (AST), alanine aminotransferase (ALT), and Bilirubin. Ultrasound showed sludge in the gallbladder without wall thickening. Magnetic resonance cholangiopancreatography (MRCP) on showed cholelithiasis. 

She was initially treated with intravenous (IV) fluid and antiemetics. Surgical consultation was obtained. The surgical service decided that urgent surgery was not required, and the patient was started on a diet. 
The patient tolerated oral intake. She was discharged from the inpatient setting. 

The health plan's determination is upheld in whole. 

An inpatient level of care was not medically necessary in this case. This patient is a female who presented to the ED with abdominal pain. Evaluation identified gallstones. She was hemodynamically stable at the time of presentation. The WBC count was normal at presentation. The surgical service advised that urgent cholecystectomy was not required. The patient remained hemodynamically stable during the period of monitoring. Care at a lower level of care status would have allowed for overnight monitoring, confirmation of clinical stability, and diet advancement. 

A lower level of care status would have been appropriate. There is no documentation of hemodynamic, pulmonary, neurological, or metabolic reason for an acute inpatient level of care at the time of presentation. There were no peri-operative complications or other clinical issues that mandated inpatient care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Obstructive sleep apnea
Treatment: CPAP Machine
The insurer denied the CPAP Machine. 
The health plan's determination is upheld.

The patient is a male who has been followed by a neurologist following a motor vehicle accident (MVA). He was being followed by neurology for complaints of headaches, dizziness, memory and cognitive difficulties--associated with the MVA.
The patient was seen by ear, nose, and throat (ENT)for evaluation of a chief complaint of bleeding from his left ear. The patient reported bleeding from his ear associated with the use of a Q-Tip. He also endorsed an intermittently clogged left ear. He reported snoring and witnessed apneas. The provider suspected obstructive sleep apnea (OSA) and referred him for a sleep study.
The patient underwent a home sleep test. The study returned positive for OSA with an REI (respiratory event index) of 21.9. He underwent an attended continuous positive airway pressure (CPAP) titration. A CPAP pressure of 10 centimeter (cm) of water was recommended.
A CPAP compliance download showed use on 26/30 days. The patient however was only noted to use CPAP for 4 or more hours per night on 14 days (47%).

The CPAP machine is not medically necessary for this patient. The generally accepted standard of practice/care in the use of CPAP for OSA is to provide continued coverage of a positive airway pressure (PAP) unit when it is shown that a patient is compliant with therapy and is deriving a clinical benefit from therapy. The American Academy of Sleep Medicine (AASM) is largely silent on the definition of "compliance". However, the generally accepted standard of this term is usage for at least 4 hours a night for 70% of nights in a 30 day period. The single compliance download provided for review showed that the patient fell well below this threshold at 47%.
There was no indication within the records provided for review showing that the patient's treating provider was attempting to address any issues which were interfering with therapeutic compliance, which is an approach recommended by guidelines (Epstein et al, Patil et al).
Given that the therapy was not otherwise being utilized and there were no definitive benefit noted from therapy (within the records provided for review), the continued use of CPAP would not be medically necessary according to the generally accepted standards of practice and or care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Failed Restoration and Caries.

Treatment: D2750 crown - tooth 13.

The insurer denied coverage for D2750 crown - tooth 13.

The denial is overturned.

Based on the submitted documentation which includes copies of periapical radiographs, panoramic radiograph, dental treatment notes, intraoral clinical images, and insurer correspondence, it appears that this patient presented for dental care. A failing restoration and caries was noted on #13 (tooth number 13) on examination and endodontic therapy was recommended. Endodontic access was through the existing crown and currently the Dentist is requesting replacement of the crown. The insurer has denied the full coverage crown stating that the service is not medically necessary as the documentation did not demonstrate medical need to support the treatment, such as caries or a missing crown and therefore the circumstance does not fulfill stated criteria for approval. The patient is appealing the decision.

Upon review of radiographs, they support the recommended treatment. Tooth #13 exhibits periapical pathology radiographically and a failing existing restoration with caries at the margin of the crown. There is ample coronal structure remaining. This tooth would require endodontic therapy to salvage the tooth which was performed. This tooth will have adequate residual coronal structure for support of a crown and adequate residual periodontal alveolar bone height. The standard of care in general dental practice would be endodontic therapy for this tooth and subsequent replacement crown which would have an excellent long-term prognosis with the recommended treatment. 

Dental code D2750 crown - tooth 13 is medically necessary as the clinical and radiographic documentation support these services, and these services would be a standard of care in general dental practice.

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.
The insurer's denial of coverage for D2750 crown - tooth 13 is reversed. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Respiratory system
Inpatient hospital

Diagnosis: shortness of breath
Treatment: Inpatient stay
The insurer denied the inpatient stay. The health plan's determination is upheld.

The patient is a male with a history of coronary artery disease (CAD) status post cardiac bypass surgery, alcohol and tobacco use, depression, back pain, hypertension, hyperlipidemia and diabetes who was admitted to the hospital. He presented with shortness of breath. He had been evaluated by his cardiologist after recent cardiac bypass surgery. Chest x-rays showed a left-sided pleural effusion. A subsequent computed tomography (CT) scan showed multiple rib fractures. Recent history was notable for smoking cessation although he had smoked a pack a day to 1 1/2 packs a day for approximately 20 years. Because of persistent pleural effusion and ongoing shortness of breath, his cardiologist referred him to the emergency department. He reported chest heaviness but denied chest pain. Vital signs showed blood pressure 133/62, and temperature 97.7 Fahrenheit. On physical exam, heart was regular, breath sounds were decreased in the left lung and crackles were audible in the right lung. The abdomen was soft and nontender. The patient was admitted with shortness of breath and left pleural effusion.

The inpatient facility stay was not medically necessary. The patient was in need of thoracentesis for management of pleural effusion, but he had a stable presentation with no evidence of significant oxygen requirement, respiratory distress, hemodynamic instability, or a complicating condition such as empyema or pneumonia. In addition, there was no evidence of worsening cardiac function and a repeat echocardiogram demonstrated an improvement in his ejection fraction. The patient did need further care, but it could have been safely and effectively provided at a lower level.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Central Nervous System/Neuromuscular Disorder/Migraine
Treatment: Pharmacy/Prescription Drug

Diagnosis: Central Nervous System/Neuromuscular Disorder/Migraine
Treatment: Pharmacy/Prescription Drug

The health plan denied the requested prescription medication. The health plan's determination is upheld.

The patient is a girl with migraine headaches. She began to have headaches when she was hit in the head while playing soccer. She had no loss of consciousness but did have photophobia. She now has headaches on a daily basis. The headaches are accompanied by nausea and dizziness. For evaluation of her headaches, she has undergone a magnetic resonance imaging (MRI) scan of the brain, which was normal. For treatment of her headaches, she has tried multiple medications, including Topiramate, Duloxetine, Gabapentin, Atenolol, and Amitriptyline, all of which have failed to control her headaches. In an attempt to control her headaches, her physician has prescribed Aimovig (erenumab).
At issue is the medical necessity of the requested prescription medication.

The health plan's determination of medical necessity should be upheld, in whole.

No. There have been no double-blinded placebo-controlled clinical trials examining the safety and effectiveness of Aimovig for the treatment of migraine headaches in people less than 18 years old. Thus, there is no scientific literature or evidence-based guidelines that strongly support the use of Aimovig for this patient's condition. Since Aimovig is not known to be safe and effective for this patient, it cannot be considered medically necessary.
Calcitonin gene related peptide (CGRP) is a naturally-occurring peptide that has potent vasodilating properties. Strong scientific evidence suggests that CGRP plays an important role in migraine headache pathophysiology, through its actions of vasodilation. Agents that can suppress the activity or concentration of CGRP could improve migraine headaches. Aimovig (erenumab) is a monoclonal antibody directed against the CGRP receptor. By blocking the receptor for CGRP, Aimovig can reduce CGRP signaling, thus reducing CGRP-induced migraine headaches. Thus, it makes physiologic sense that Aimovig could improve migraine headaches. Indeed, clinical trials have demonstrated the clinical efficacy of Aimovig against migraine headaches. However, to date, clinical trials for Aimovig have been conducted only in adults. Aimovig is FDA-approved for the treatment of migraine headaches in adults only (people 18 years of age and older). Aimovig has not been shown to be safe and effective against migraine headaches in people less than 18 years old. Therefore, because Aimovig is not known to be safe and effective for people less than 18 years old, the health plan did act reasonably, with sound medical judgement, and in the best interests of the patient by denying coverage of it.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cervical Dystonia.
Treatment: Xeomin.

The insurer denied Xeomin.  The determination is upheld.

The patient has a listed diagnosis of cervical dystonia. The information provided indicates that he has a dystonic head tremor, as well as a right turn, left tilt and anterocollis. Xeomin 600 units is requested. No failure of standard dosing is properly documented. Low quality peer reviewed journal articles are provided as well, none of them recommending the requested dosing. At issue is whether the Xeomin 600 units is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

There is insufficient evidence from high quality peer reviewed literature, large, well designed, blinded, randomized trials to support long term superiority of the requested drug, Xeomin, at the high doses requested, over all other available options including standard Xeomin or Botox doses. The manufacturer of Xeomin states "In a placebo-controlled trial utilizing initial XEOMIN doses of 120 Units and 240 Units, no meaningful difference in effectiveness was demonstrated between the doses", indicating that doses of 240 units were not superior to doses of 120 units. This reviewer could not find in their information any recommendation for doses of 600 units. (7)

There is insufficient evidence from high quality peer reviewed literature, large, well designed, blinded, randomized trials to support long term safety and efficacy of the requested drug, Xeomin, at the requested doses, for this patient's condition, cervical dystonia, as described.

The manufacturer of Botox, whose doses are converted on a 1:1 ratio with Xeomin, states the following: "In treating adult patients for 1 or more indications, the maximum cumulative dose should not exceed 400 Units in a 3-month interval."

The manufacturer of Xeomin, albeit not specifying a maximum doses, states the following: "The recommended initial dose of Xeomin for cervical dystonia is 120 Units".
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cervical Dystonia.
Treatment: Xeomin.

The insurer denied Xeomin.  The determination is upheld.

The patient has a history of cervical dystonia. The patient is treated with Xeomin and clonazepam. The plan has denied the request for 600 units every 12 weeks, as the maximum recommended dose is 400 units every 12 weeks. At issue is whether Xeomin 600 units is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

There is no evidence available to suggest that the requested dose of Xeomin 600 units is likely to be more beneficial than the any standard treatment, which is Xeomin less than or equal to (<=) 400 units. Although the provider submits evidence to show that Xeomin is safe and effective for treatment of cervical dystonia, there is no evidence presented to show that Xeomin 600 units is equal or superior to "standard" doses of Xeomin.

In the majority of clinical studies examining the safety and efficacy of Xeomin for treatment of cervical dystonia, a dose of 120 units or 240 units was used. In most of these studies, there was not a difference in the two treatment doses (1, 2, 3). The reviewer located one small study to show that "high dose" Xeomin between 400-1200 units was safe; however, there was no data presented to show that the higher doses were more effective (4).
Therefore, the Xeomin 600 units is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.