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


Diagnosis: Chronic Obstructive Pulmonary Disease (COPD)
Treatment: Breztri Aerosphere 
The insurer denied Breztri Aerosphere. 

The health plan's determination is upheld. 

This is the case of a female patient who suffers from chronic obstructive pulmonary disease (COPD), asthma and interstitial lung disease. The patient is on oxygen for chronic respiratory failure with hypoxemia. She is treated with Xarelto for pulmonary embolism. The patient continues to have shortness of breath, the patient was prescribed Breztri. The patient has a history of arthritis, hypertension, and congestive heart failure. 

Breztri Aerosphere is not medically necessary for this patient.
The patient suffers from interstitial lung disease (ILD) and COPD. There is no convincing or objective evidence in the submitted documents that the patient has contraindication to or a potential drug interaction with formulary alternatives (Stiolto, Striverdi and Symbicort). There is no evidence that the patient is intolerant to or has had a confirmed adverse event with formulary alternatives (Stiolto, Striverdi and Symbicort). There is no evidence that the patient has demonstrated an inadequate treatment response after a trial of formulary alternatives (Stiolto, Striverdi and Symbicort)
There are no national guidelines that support the routine use of Breztri over Stiolto, Striverdi and Symbicort for the treatment of ILD and COPD as in this patient case. Therefore, the patient does not meet medical necessity criteria for the requested medication.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Endocrine/Metabolic/Nutritional/Pediatric Growth Hormone Deficiency.
Treatment: Pharmacy/Prescription Drugs/Norditropin.
The health plan denied the requested prescription medication, Norditropin, as not medically necessary. 
The health plan's determination is overturned.

This is a male diagnosed with growth hormone deficiency (GHD). This request is for Norditropin. His growth hormone (GH) stimulation test  with Glucagon and Clonidine peaked at 6.8. His height velocity is reported to be 4.5 centimeters/year (cm/yr). Provider reported he has poor Insulin-like Growth Factor 1 (IGF1) and Insulin-like growth factor binding protein 3 (IGFBP3) is on the lower range of normal.
His height was 127 centimeters (cm) (-2.45 standard deviation score (SDS)) and later was 130.7 cm (-2.35 SDS).

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

Yes. The requested health service/treatment of Norditropin is medically necessary for this patient.
The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below:
Classic GH deficiency
Classic GH deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH deficiency published by the GH research society, [1]the Lawson Wilkins Pediatric Endocrinology Society, [2, 3] and the medical guidelines for GH use provided by the American Association of Clinical Endocrinologists.[4] The above referenced guidelines are the latest available guidelines from these respective societies. The diagnosis is based on height, height velocity, biochemical and sometimes radiological findings. The height and height velocity criteria based on consensus guidelines upon which a biochemical evaluation is to be initiated are 1) severe short stature, defined as a height more than 3 standard deviation (SD) below the mean; 2) height more than 1.5 SD below the mid parental height SD; 3) height more than 2 SD below the mean and a height velocity over 1 year more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 year in children over 2 years of age; 4) in the absence of short stature, a height velocity more than 2 SD below the mean over 1 year or more than 1.5 SD sustained over 2 years. The biochemical criteria include low IGF1 or IGFBP3 or GH stimulation testing with a peak GH less than 10 nanograms/milliliter (ng/ml).
 
This patient met biochemical criteria. GH stimulation testing peaked at less than 10ng/ml. The patient met height criterion 3 as his height is more than 2 SD below the mean and height velocity is more than 1 SD below the mean at 4.5 cm per year. The patient met both height and height velocity and biochemical criteria for the diagnosis of GH deficiency. GH in the treatment of GH deficiency is medically necessary. The patient meets the accepted criteria for the diagnosis of growth hormone deficiency.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Back Pain
Treatment: Implantable Nerve Stimulate Device (63650x1, L8680 x1)
The insurer denied: Implantable Nerve Stimulate Device (63650x1, L8680 x1)
The denial is upheld.

The patient is an adult male with low back pain radiating to the left lower extremity.  The patient tried a left L4-5 (lumbar four to five) transforaminal epidural steroid injection (TFESI) with 80% relief. The patient has further tried several previous transforaminal epidural steroid injections at left L5-S1 (lumbar five to sacral one) and medial branch blocks and radiofrequency ablation at bilateral L3-S1 (lumbar three to sacral one). The patient is currently utilizing Naprosyn and a compound cream and has tried previous physical therapy and home exercise.  

Magnetic resonance image of the lumbar spine is significant for a left paracentral disc extrusion at L5-S1 (lumbar five to sacral one) with nerve impingement. Magnetic resonance image of the thoracic spine is without significant stenosis. Psychological evaluation shows appropriate coping skills. The request for spinal cord stimulation was denied.

The proposed treatment is not medically necessary.

Spinal cord stimulation (SCS) is medically necessary for patients with failed back surgery syndrome or complex regional pain syndrome. High-level evidence supports spinal cord stimulation for treating chronic pain and complex regional pain syndrome. For patients with failed back surgery syndrome, spinal cord stimulation was more effective than reoperation or medical management. However, this patient does not have evidence of either of these diagnoses. 

New stimulation waveforms and frequencies may provide a greater likelihood of pain relief compared with conventional spinal cord stimulation for patients with axial back pain, with or without radicular pain. In one study of 20 patients it was demonstrated that anatomical placement of leads with sub-perception high dose (HD) stimulation could provide effective pain relief in patients who are not candidates for spinal surgery.  However, larger studies need to be done to prove its efficacy and medical necessity in these cases.  

Therefore, the requested health service is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Crohn's Disease. 
Treatment: Entyvio (vedolizumab). 

The health plan denied the requested medication, Entyvio (vedolizumab) as not medically necessary. 

The health plan's determination is upheld. 

The patient is a male with Crohn's sigmoid colitis along with ileitis on the most recent colonoscopy. The patient has previously tried and failed therapy with Mesalamine and corticosteroids. More recently, the patient underwent robotic sigmoidectomy for diverticulitis and the surgery was complicated by an anastomotic leak. He now has a diverting ileostomy. The patient was readmitted to the hospital with a new pre-sacral collection. 

The patient's provider has recommended treatment with Entyvio. On a progress note it is listed that he is already on this therapy but a later in note says he needs to start medications for Crohn's. Per the provider, Entyvio is preferred due to the lower risk of infection in a patient of advanced age. This request was denied by the plan. The plan requires that first line therapy be an anti- tumor necrosis factor (TNF) agent, usually infliximab or adalimumab and that Entyvio is not medically necessary. 

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

No, there is no randomized data comparing Entyvio to anti-TNF therapy directly in Crohn's disease, only ulcerative colitis. However, a very comprehensive network meta-analysis by Singh et al. ultimately reviewed data from 31 trials.[1] On the basis of 15 of the randomized controlled trials including 2931 biologic-naive patients, infliximab monotherapy (odds ratio [OR] 453 [95% confidence interval (CI) 149-1379]) and infliximab combined with azathioprine (749 [204-2749]) were associated with significantly higher odds of inducing remission compared to vedolizumab (376 [101-1403]). No differences between active interventions were observed in maintenance trials. Most trials were at low or uncertain risk of bias. 

In a previous meta-analysis using some of the same trials, these same authors found that in biologic-naive patients, infliximab and adalimumab were ranked highest for induction of clinical remission in Crohn's disease. 

Although the safety profile is somewhat better for Entyvio, the clinical efficacy is likely to be significantly higher with anti-TNF agents. In my opinion, the plan is justified in this denial for Entyvio.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Left upper extremity weakness
Treatment: Inpatient hospital stay
The insurer denied the inpatient hospital stay.
The health plan's determination is upheld.

The patient is a female who initially presented to the emergency department with concerns of left upper extremity weakness and pain for over one week duration. Pertinent history included back pain, diabetes mellitus, hypertension, diabetic neuropathy, seizure disorder, and chronic obstructive pulmonary disease. 

Based on the clinical documentation provided, the inpatient hospital admission was not medically necessary.

Woods, et al note cervical radiculopathy is a relatively common neurological disorder resulting from nerve root dysfunction, which is often due to mechanical compression; however, inflammatory cytokines released from damaged intervertebral disks can also result in symptoms. Cervical radiculopathy can often be diagnosed with a thorough history and physical examination, but an magnetic resonance imaging or computed tomographic myelogram should be used to confirm the diagnosis. Because of the ubiquity of degenerative changes found on these imaging modalities, the patient's symptoms must correlate with pathology for a successful diagnosis. In the absence of myelopathy or significant muscle weakness, all patients should be treated conservatively for at least 6 weeks. Conservative treatments consist of immobilization, anti-inflammatory medications, physical therapy, cervical traction, and epidural steroid injections. Cervical radiculopathy typically is self-limiting with 75%-90% (percent) of patients achieving symptomatic improvement with nonoperative care. For patients who are persistently symptomatic despite conservative treatment, or those who have a significant functional deficit, surgical treatment is appropriate. Surgical options include anterior cervical decompression and fusion, cervical disk arthroplasty, and posterior foraminotomy.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Urinary tract infection
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission
The denial is upheld.

This is a patient with past medical history of left nephrectomy, frequent urinary tract infections and interstitial cystitis. Patient presented to emergency department (ED) with complaint of right flank pain radiating to the lower abdomen, hematuria, nausea. Patient was recently admitted to another facility with similar complaints. Patient was treated with intravenous (IV) Cefepime at that time and signed out against medical advice (AMA). In the ED urinalysis was positive for urinary tract infection, computed tomography (CT) imaging revealed likely cystitis. Patient was admitted to the medical floor for care, she was started on IV fluids and IV antibiotics. Pain medicine given as needed (PRN). Patient signed out AMA. The insurer has denied coverage for the inpatient admission as not medically necessary. They noted the patient's presentation to ED and cited a lack of hemodynamic, pulmonary, neurologic, or metabolic reason to treatment the patient at an acute level of care. The appeal on behalf of the hospital is noted and read in detail. 

Per Milliman Care Guideline (MCG) Health (25th) urinary tract infection - RRG; patient fails to meet clinical indications for admission to inpatient care. There was no history of hemodynamic instability, altered mental status that is severe or persistent, ureteral obstruction (stone), impaired bladder emptying, or persistence/ worsening of clinical findings despite observation care.

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

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

Diagnosis: Rheumatoid arthritis, hypertension, essential tremor, hyperlipidemia, coronary artery disease (CAD)
Treatment is a personal care aide (PCA) level 2: 7 hours per day - 7 days per week for a total of 49 hours per week
The insurer denied coverage for a personal care aide (PCA) level 2: 7 hours per day 7 days per week for a total of 49 hours per week
The denial is overturned.

This patient has experienced functional decline associated with several medical conditions. He was living with his wife until recently. The patient now lives alone. The patient has been receiving personal care aide (PCA) services to assist with ADLs (activities of daily living) and IADLs (instrumental activities of daily living). The insurer approved PCA 21 hours per week, 3 hours per day for the patient. The letter from the home care agency reported that aide services had been provided as a mutual case for the patient and his wife for a total of 7 hours per day. When the wife was hospitalized, and now following her death, there are no mutual services; and so, the patient is receiving PCA services 3 hours per day, 7 days per week. The patient requested increase of PCA services to 49 hours per week, 7 hours per day, which was denied. An external appeal was requested.

The UAS (uniform assessment system) identified one informal helper who was providing some assistance at that time. Current availability of the informal helper is not known, but considering the patient requested an increase of PCA services from 3 hours to 7 hours per day, it is reasonable to conclude that there are no informal helpers who can provide assistance for that additional amount of time each day. Assistance from informal caregivers is voluntary as per NYS (New York State) regulations for personal care services. When informal caregivers are unable to provide care on a consistent basis, then personal care services are indicated to provide necessary assistance for daily activities. 

The information provided for review supports the need for an increase of PCA services. Considering the physician's report of the patent's decreased mobility and need for assistance with most ADLs, PCA services 7 hours per day will provide more assistance for daily activities during hours of the day when the patient is most active. If necessary, the hours may be split to provide assistance for a period of time in the morning and afternoon, then later in the day for dinner and evening ADLs. 

Re-assessment will update the patient's functional status and help determine whether PCA 49 hours per week meets the patient's care needs or if further modification of the plan is necessary.

Recommendation is given to approve Personal Care Aide services Level 2: 7 hours per day, 7 days per week; total of 49 hours per week.

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for the personal care aide (PCA) level 2: 7 hours per day - 7 days per week - for a total of 49 hours per week is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Uterine Fibroids
Treatment: code 404T transcervical uterine fibroids ablation with ultrasound guidance, radiofrequency with Sonata System
The insurer denied coverage for code 404T transcervical uterine fibroids ablation with ultrasound guidance, radiofrequency with Sonata System
The denial is upheld

The patient has complaints of pelvic pressure and a diagnosis of uterine fibroids.

The physician discussed a hysterectomy. The patient requested coverage for code 404T transcervical uterine fibroids ablation with ultrasound guidance, radiofrequency with Sonata System. Magnetic Resonance Imaging (MRI) showed multiple fibroids the largest being 8.1 cm (centimeters).

The Sonata system is Food and Drug Administration (FDA) approved for the management of fibroids. There are multiple studies documenting the safety and efficacy of this procedure in controlling symptoms due to fibroids.

The use of the Sonata system in this patient's case is not indicated as some of the fibroids are greater than the 5 cm size that is reported in all the published studies about the efficacy and safety of Sonata. In other words, there are no data about the effectiveness of the sonata system in patients with larger fibroids. There is suggestion that larger fibroids above 5 cm may require the application of multiple ablations (i.e., multiple procedures).

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

The insurer's denial of coverage for the code 404T transcervical uterine fibroids ablation with ultrasound guidance, radiofrequency with Sonata System is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned


Diagnosis: Congenital Absence of Left Hand or Finger; Congenital Absence of Right Hand or Finger; Congenital Absence of Hand and Finger, Bilateral
Treatment: Prosthetics
The insurer denied the prosthetics.

 The health plan's determination is overturned.

This is a male with human immunodeficiency virus (HIV) and left total hip replacement (THR) who has congenital absence of fingers bilaterally. He has been evaluated for two right proximal inter-phalangeal (PIP) protheses, one right metacarpophalangeal (MCP) prosthesis and on left MCP prosthesis. These were denied by the health plan as not medically necessary.

These prosthetic devices are medically necessary for this patient. They will allow him greater manual function with improved fine motor skills. He is a music teacher and these prostheses they will allow him greater ability to teach with his instruments. The devices will also allow an improved ability to perform activities of daily living. They are body powered as the passive devices do not improve grip or pinch.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Headaches
Treatment: Emgality
The insurer denied Emgality.
The determination is upheld.

The patient has a listed diagnosis of "headaches". Actual records indicate a diagnosis of migraines. The type of migraine, i.e., episodic, chronic or another, is unclear/not specified. It is unclear how such diagnosis was established. Notes indicate the patient developed headaches after a traumatic head injury, with associated symptoms including dizziness, "mental fogginess", problems concentrating, hypersomnolence, drowsiness, feeling nervous.
An appeal letter reports failures of the following:
-	lamotrigine, magnesium, fluoxetine, nortriptyline, cyproheptadine, none of which are generally accepted as proven migraine prophylactic agents.
-	low dose amitriptyline and propranolol
-	venlafaxine
At issue is whether Emgality is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Emgality is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Emgality is only proven in the treatment of migraines. However, the submitted medical records do not establish a diagnosis of migraines, given multiple atypical characteristics, and immediate association with traumatic head injury.
In addition, 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, Emgality, for this patient's condition, pediatric migraines, as described. Emgality is unproven in the pediatric population.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Headaches
Treatment: Emgality
The insurer denied Emgality.
The determination is overturned.

The patient has migraine headaches, anxiety, and primary generalized epilepsy. She has had intermittent migraine headaches since a young age. However, in recent years, they have become more frequent and problematic. The migraine headaches were especially worsened following a concussion at which time she was hit on the head during cheerleading practice by another cheerleader. For her frequent migraine headaches, she has tried all of the first-line treatments, including amitriptyline, nortriptyline, propranolol, lamotrigine, magnesium oxide, venlafaxine, and fluoxetine. All of these medications either failed to improve her headaches or caused unacceptable side effects. She has been treated with Emgality. On the Emgality, the headaches are much improved. Whereas she was having multiple headaches per week before the Emgality, she has had only a single headache in two months while on the Emgality. However, Emgality is Food and Drug Administration (FDA)-approved for the treatment of migraine headaches only in patients 18 years of age and older. At issue is whether Emgality is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Yes. Calcitonin gene-related peptide (CGRP) and its receptor play an important role in pain pathways, including migraine headaches. Antibodies directed against CGRP and its receptor can ameliorate migraine headaches. Emgality is a monoclonal antibody directed against CGRP. Studies in adults (patients 18 years of age and older) have shown that Emgality is safe and effective as prophylaxis against migraine headaches. As a result, Emgality is FDA-approved for prophylaxis against migraine headaches in adults. Very few studies have been conducted regarding the use of CGRP antibodies in children. The few studies that have been done suggest that it is safe and effective. However, the evidence is not yet strong enough to gain FDA approval. This patient is adult-sized. Her anatomy and physiology at her age are very similar to those of an adult. She is disabled by frequent migraine headaches. She has been on Emgality for two months and has responded very well to it, with no evident side effects.
Therefore, it is likely that Emgality would be more beneficial than any standard treatment.