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

Diagnosis: Major depressive disorder

Treatment: Replacement of vagus nerve stimulator

The insurer denied coverage for replacement of a vagus nerve stimulator.

The denial is overturned. 

This female patient has diagnoses of post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). She is receiving medication management, cognitive behavioral therapy (CBT), psychoeducation and has a vagus nerve stimulator (VNS) that was implanted 12 years ago for treatment resistant depression. 

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome with VNS. Conway CR, et al, concluded "Compared to TAU (treatment as usual), adjunctive VNS significantly improved QOL (quality-of-life) in TRD (treatment-resistant depression), and this QOL advantage was sustained. Further, TRD patients treated with VNS experienced clinically meaningful QOL improvements even with depression symptom reduction less than the conventional 50% reduction used to ascribe "response." 

Aaronson ST, conclude, "This registry represents the longest and largest naturalistic study of efficacy outcomes in treatment-resistant depression, and it provides additional evidence that adjunctive VNS has enhanced antidepressant effects compared with treatment as usual in this severely ill patient population." 

The patient has had the VNS implant for 12 years. She was able to continue employment, had decrease in suicidal ideations and no suicide attempts or gestures. Surgical interventions are reserved for patients with major depression who are refractory to multiple courses of pharmacotherapy, psychotherapy, and non-invasive neuromodulation interventions (eg, electroconvulsive therapy and transcranial magnetic stimulation).

The requested service is likely to be more beneficial that any of the standard treatments/procedures for this patient.  

The carrier's denial of replacement implantation of vagus nerve stimulator should be overturned.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Major depressive disorder

Treatment: Replacement of vagus nerve stimulator

The insurer denied coverage for replacement of a vagus nerve stimulator.

The denial is overturned. 

This female patient had depressive symptoms including depressed mood and suicidal ideation and had a 20 year history of depression and diagnosis of Major Depressive Disorder-Severe, recurrent. She tried multiple past anti-depressant medications and past electroconvulsive therapy (ECT) as well as past psychotherapy treatment. She reportedly took anti-depressant medications including Pristiq, Wellbutrin, Trazodone, Ritalin, and Abilify. She also reportedly took Deplin as an adjunctive to help target depression as well as Gabapentin, Zyprexa, and Klonopin. She reportedly had significant and sustained improvement with vagus nerve stimulation therapy (VNS).

According to the APA Practice Guidelines for the Treatment of Patients with Major Depressive Disorders the FDA approved vagus nerve stimulation for chronic depression of patients 18 years or older for patients who had at least 4 adequate trials of antidepressants and/or ECT. In this case this patient had more than 4 trials of antidepressants as well as ECT and had a diagnosis of Major Depressive Disorder so she was considered a candidate for this treatment and it is considered standard treatment for major depressive disorder. 

According to O'Reardon, VNS was approved by the FDA for the treatment of severe, recurrent depression in July of 2005. VNS adopts a bottom-up approach to modulating the neural circuitry of depression by stimulating vagal afferent fibers in the neck, which carry impulses to the brain stem to target the locus ceruleus and dorsal raphe nucleus. It modulates the concentration of neurotransmitters providing functional activity in the central nervous system (CNS) and its mode of action was similar to antidepressants. VNS moved beyond the experimental phase and into the clinic for psychiatrists to use for patients with treatment resistant depression. The peer reviewed literature supports that VNS can improve health outcomes, and it has final approval from regulatory bodies as it was FDA approved for treatment of depression since July 2005. This patient was considered a good candidate for VNS as she had more than 4 trials of antidepressants including different classes of antidepressant medications including serotonin norepinephrine reuptake inhibitor, dopamine norepinephrine reuptake inhibitor, psychostimulants, dopamine agonist antagonist, and a heterocyclic, as well as ECT, and she had a diagnosis of Major Depressive Disorder-severe-recurrent. She reportedly had significant and sustained improvement and benefit with vagus nerve stimulation therapy (VNS) so it appeared to be the best available treatment for her and was more likely to be beneficial for her depression than other standard treatments. As a result, the recommendation is to reverse the previous decision and approve coverage for vagus nerve stimulation. 

The carrier's denial of replacement implantation of vagus nerve stimulator should be overturned.
Appeal type: Medical necessity
Decision: Upheld

Infectious disease
Pharmacy/Prescription drugs

Diagnosis: Hepatitis
Treatment: Epclusa
The insurer denied Epclusa. The health plan's determination is upheld. 

The patient is a male infected with hepatitis C, Genotype 1a. Viral load is 536,529. The patient has advanced liver disease to the point of decompensated cirrhosis due to hepatitis C along with ethyl alcohol (ETOH) abuse. The patient has required large volume paracentesis in the past. Model for End-Stage Liver Disease (MELD) score = 9. The patient's latest hemoglobin is 13.2 g/dl. The patient's provider has recommended treatment with Epclusa monotherapy for 24 weeks.

Epclusa is not medically necessary for this patient.
The study from the ASTRAL-4 investigators used as a reference in appeal by the provider was a phase 3, open-label study involving both previously treated and previously untreated patients infected with hepatitis C virus (HCV) genotypes 1 through 6 who had decompensated cirrhosis such as this patient. This study is the most relevant in evaluating this case and it makes the opposite argument than the providers are putting forth. Patients were randomly assigned to receive Epclusa once daily for 12 weeks, Epclusa plus ribavirin for 12 weeks, or Epclusa for 24 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy (standard definition). The difference for the Epclusa + riba vs. Epclusa alone for 24 weeks was 94% vs. 93%. A total of 8 patients discontinued study treatment prematurely because of an adverse event: 4 of 87 patients (5%) who received Epclusa and ribavirin, and 4 of 90 patients (4%) who received Epclusa for 24 weeks.
In the group that received Epclusa plus ribavirin, decreases in hemoglobin to less than 10.0 g per deciliter occurred in 23% of patients and decreases to less than 8.5 g per deciliter in 7% of patients. In the group that received Epclusa for 24 weeks the rates of decrease in hemoglobin were 9% and 1%. Anemia or reductions in hemoglobin were successfully managed in the majority of patients with a modification of or interruption in the ribavirin dose, and 1 patient was treated with erythropoietin.
In my opinion, this highly relevant paper argues that 12 weeks of Epclusa + ribavirin is appropriate and that the dose of ribavirin can be adjusted as needed if anemia develops without sacrificing sustained virologic response (SVR). The patient's baseline hemoglobin is @ 13.5 so there is a significant margin even if the count drops 3 grams. Therefore, Epclusa is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Disorder Treatment: OB/GYN Services. 
The insurer denied the requested surgery. 
The denial is overturned in whole. 

The patient is a female with vulvar vestibulitis. She has had dyspareunia described as burning, rawness and cutting with intercourse attempted. She has attempted pelvic floor physical therapy, amitriptyline/baclofen/gabapentin cream and injectables with local anesthetic. There has been no relief in her symptoms. She has also attempted vaginal dilators. She would like a vulvar vestibulectomy with vaginal advancement. There is a question of the medical necessity of the surgery. The health plan's determination of medical necessity is overturned in whole. The requested health service/treatment of vulvar surgery is medically necessary for this patient. The known treatments for vulvodynia/vulvar vestibulitis include physical therapy, perineoplasty and vestibulectomy (if conservative measures including vulvar care, physical therapy, pharmacotherapy including analgesics have failed). The patient has failed medication with creams and injectables. She has failed physical therapy per the letters of necessity. No office notes were provided, and all history was from letters. Vestibulectomy is a known treatment when all conservative measures have failed. Excisional vestibular surgery is an approach advocated in some centers for localized vulvodynia when other treatments have failed. Experts have concluded that the need for evidence-based, "stepped care" guidelines for clinical management of vulvodynia is warranted. In 2006 a study looked at success rate with vestibulectomy. Overall, 93% of women were satisfied with the surgery and the authors concluded that in this cohort of patients, there was a high degree of satisfaction with surgery. In addition, the risks of complications with this procedure were low, and most complications were transient and the risk of recurrence after surgery was also found to be low. In another study, after surgery, 93 % of the patients could have sexual intercourse compared with 78 % before surgery. The authors concluded that surgical treatment achieved high success rates with an acceptable rate of complications. Age of 30 years or younger was associated with a better outcome.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Respiratory System. 
Treatment: Durable Medical Equipment. 
The insurer denied Ventilator. 
The denial is upheld in whole.

The patient is a female who suffers from severe chronic obstructive pulmonary disease (COPD). The patient has history of bronchiectasis. The patient has chronic dyspnea. The patient is on oxygen and inhalers. The patient was placed on the noninvasive ventilator Life 2000 to improve the patient daytime endurance. The subject under review is the medical necessity for the Ventilator - E0466- RR x 12.

No, the requested service of Ventilator E0466-RR x 12 is not medically necessary for this patient.

Murphy et al., performed a randomized clinical trial of patients with persistent hypercapnia (partial pressure of arterial carbon dioxide [Paco2] greater than [>] 53 millimeters of mercury [mmHg]) to home oxygen alone or to home oxygen plus home noninvasive ventilator (NIV). The median time to readmission or death was 4.3 months in the home oxygen plus home NIV group vs 1.4 months in the home oxygen alone group. The 12-month risk of readmission or death was 63.4% in the home oxygen plus home NIV group vs 80.4% in the home oxygen alone group with absolute risk reduction of 17.0% (95% confidence interval [CI], 0.1%-34.0%). The final conclusion was among patients with persistent hypercapnia following an acute exacerbation of COPD, adding home noninvasive ventilation to home oxygen therapy prolonged the time to readmission or death within 12 months.
According to Storre et al., Home-NIV for patients with end-stage COPD has become a well-established form of therapy over the last few decades. Recent research trials have provided evidence that Home-NIV is associated with long-term survival benefits as well as improvements in HRQL, gas exchange, and lung function. These positive results were observed in the stable hypercapnic COPD patient subgroup. 
This patient has history of severe COPD. There is no evidence that the patient baseline PCO2 is greater than 52 mmHg on an arterial blood gas. Also, there is no evidence that the patient tried and failed or has contraindication to alternative standard of care treatment such as bi-level positive airway pressure (BiPap). There is no evidence that the portable noninvasive ventilator Life 2000 can improve this patient outcome. There is no evidence in term of large randomized trials that the requested service is superior to standard care for the treatment of patients with severe COPD, therefore the treatment is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Common variable immune deficiency 
Treatment: Gamunex C. The insurer denied Gamunex C.
The determination is overturned.

The patient has common variable immune deficiency (CVID) and is requesting immune globulin. Immunoglobulin G (IgG) 205, IgA and IgM were undetectable. The patient has been followed since age 8 and has been on various doses of intravenous immunoglobulin (IVIG), Gamunex for years. At issue is the medical necessity of Gamunex-C.
The Gamunex-C is medically necessary for this patient.
The patient has profoundly low immune globulin levels. Per the standard of care, immune globulin replacement is standard of care and would be consistent with CVID. Per practice parameters and current literature, immunoglobulin replacement in patients with CVID have shown to be beneficial for infection prevention and control. In a large series of 2212 patients with CVID, patients receiving intravenous immunoglobulin therapy (IVIG) at doses yielding higher serum levels had fewer serious infections and days of hospitalization for primary immunodeficiency, compared with those with lower serum levels per Gathmann et al.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Intermittent right sided weakness, slurred speech and paresthesia 
Treatment: Acute Inpatient Stay 
Decision: Denied 

Summary:
The member is a male with a history of depression, insomnia, chronic back pain who presented  with the complaint of intermittent right sided weakness, slurred speech and paresthesia. At presentation he had a normal neurological examination. Work-up was negative for acute stroke and he was discharged home. 

The patient presented with transient neurological symptoms. At presentation he had a normal neurological examination and negative neuro-imaging.  Risk stratification of stroke based on presentation symptoms, examination and diagnostic studies did not warrant acute inpatient admission. The clinical evaluation, diagnostic testing, treatment and monitoring could have been safely and effectively provided at a lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Right leg pain
Treatment: Inpatient admission
The insurer denied the inpatient admission. 
The denial is overturned.

The Inpatient admission was medically necessary.

The patient is a male whose inpatient admission is under review. The patient presented to his PMD's (primary medical doctor) office five days prior to hospitalization. He was found to have RLE (right lower extremity) cellulitis, given IM (intramuscular) ceftriaxone and placed on PO (oral) levofloxacin. The patient's symptoms worsened with rash extending up his leg to groin.

In the ER, the patient's vitals were as follows: T (temperature) - 98.1, P (pulse) - 76, RR (respiration rate) - 20, and BP (blood pressure) - 177/98. On general examination, the patient was NAD (no acute distress). The patient's CVS (cardiovascular system), pulmonary, and abdominal examinations were normal. Examination of the patient's skin revealed erythema to right leg, tracking up to groin. Swelling, circumferential, no crepitus were noted.

The patient's labs were as follows:
WBC (white blood count): 5.4, Hg (hemoglobin) - 16.1, Hct (hematocrit) - 49.3, Plt (platelets) - 238, Na (sodium) - 142, K (potassium) - 4.1, Cl (chloride) - 105, CO2 (carbon dioxide) - 28, BUN (blood urea nitrogen) - 18, Cr (creatinine) - 0.9

The patient was thought to have cellulitis, failure of outpatient therapy with extension of infection. He was started on IV ceftriaxone and PO (oral) doxycycline, and then IV vancomycin. He was then changed to Linezolid. He had a culture result of GNR (gram negative rod) (Moraxella), determined to be a contaminant. He improved and was sent home on PO antibiotics.

The patient meets the initial criteria for IV treatment and admission for cellulitis/abscess given by the Infectious Diseases Society of America (1), as he failed outpatient therapy. The patient had a long history of cellulitis, so there was concern about resistance as well. Thus, this admission was warranted, supported by IDSA guidelines, as well as standard of care. Failure to admit such a patient can lead to loss of function, sepsis, deep abscess, or death.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Metastatic lung cancer
Treatment: Guardant 360 Test 

The health plan should not cover the Guardant 360 Test.

The patient is a male with NSCLC (non-small cell lung cancer), ALK+. He has received therapy with crizotinib, alectinib, and lorlatinib. His AP performed Guardant 360 testing.

The Guardant 360 Test is not likely to be more beneficial.

There is no evidence to support the use of NGS (next generation sequencing) panel testing in the evaluation and management of patients with known metastatic ALK+ NSCLC. The NCCN does not support the use of NGS panel testing following progression in patients with known ALK+ disease.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Metastatic lung cancer
Treatment: Guardant 360 Test 
The insurer denied the Guardant 360 Test.
The denial is upheld. 

The health plan should not cover the Guardant 360 Test. 

The patient is a male. The patient in this case was diagnosed with advanced non-small cell lung cancer. He was found to have an EML4-ALK translocation on molecular testing at the time of diagnosis. He was initially treated with crizotinib and following disease progression was changed to alectinib. He was eventually taken off that with CNS (central nervous system) progression and was then treated with lorlatinib. He did well on that. Records note that imaging done revealed no evidence of disease progression. However, later he was found to have a new metastatic lesion in the L3 vertebral body, which was causing pain. He was taken off lorlatinib and treatment with chemotherapy was recommended.

Guardant 360 testing was performed.

Guardant 360 is a next generation sequencing (NGS) assay performed on circulating cell free DNA. This testing is done to look for genomic alterations to try to find potential treatment options. At the present time, there is no evidence from any prospective clinical trial indicating that such testing can improve overall health outcomes. Furthermore, this type of testing remains under active investigation to see if it can improve overall health outcomes. Given both lack of sufficient supporting data and presence of ongoing studies, this testing should be considered investigational at the present time. Therefore, the health plan should not cover this testing.

Based on lack of sufficient supporting data, as noted above, the Guardant 360 Test is not likely to be more beneficial.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

Diagnosis: Chronic bilateral low pelvic/groin pain

Treatment: Dorsal root ganglion spinal stimulator

The insurer denied coverage for a dorsal root ganglion spinal stimulator.

The denial is upheld.

The patient is a male who presented after not being seen for several months. He was using gabapentin with some relief but this caused constipation and he stopped this. Dorsal root ganglion (DRG) was discussed. He has a deep pressure aching pain in the mid groin extending into the scrotal region. This started on the right but is now bilateral. He has failed non-steroidal anti-inflammatory drug (NSAIDs), ice, and rest. He failed gabapentin. Previous inguinal nerve block (NB) provided 80% relief but lasted only 3 months. He has a history of prior umbilical hernia repair and orchiopexy. Exam demonstrated no abdominal tenderness and no palpable masses. The patient was interested in DRG. 

A psychological evaluation was requested most recent inguinal nerve block. He was seen by a clinical Psychologist. Initiation of mental health counseling to address mood prior to trial candidacy was recommended. An appeal letter indicates that DRG trial is for chronic post procedural and bilateral lower quadrant abdominal pain. There is a note that he has been "cleared by a psychologist."

In cases of chronic pelvic pain, there is lack of evidence to support the use of dorsal root ganglion spinal stimulator. Although there is some potential benefit, at this time dorsal root ganglion spinal stimulator for the treatment of chronic bilateral low pelvic/groin pain would be considered likely to be more beneficial than any other standard treatments/procedures. Therefore, the scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.


This procedure as noted above is not likely to be more beneficial than any standard treatments/procedures for this patient.                                                    

The carrier's denial of a dorsal root ganglion spinal stimulator for the treatment of chronic bilateral low pelvic/groin pain should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2:

Diagnosis: Chronic bilateral low pelvic/groin pain
Treatment: Dorsal root ganglion spinal stimulator
The insurer denied coverage for a dorsal root ganglion spinal stimulator the treatment of chronic bilateral low pelvic/groin pain
The denial is upheld.

This is a male with a past medical history bilateral groin and scrotal pain. The patient described his chronic bilateral low pelvic/groin pain as a deep pressure, aching pain that will start mid groin and extend down to his scrotal area. The pain is prompted by bowel movements, bearing down and with intercourse. The patient had inguinal nerve blocks that provided 60% relief but only lasted 3 weeks at a time. His physician who specializes in Anesthesiology and Pain Management discussed a dorsal root ganglion spinal stimulator to treat his pain.

The International Neuromodulation Society convened a Neuromodulation Appropriateness Consensus Committee (NACC) to develop best practices for the use of dorsal root ganglion (DRG) stimulation for the treatment of chronic pain syndromes. The NACC was comprised of experts in anesthesiology, neurosurgery, and pain medicine. The NACC performed a systematic literature search through June 2017 and identified 29 publications providing evidence for the consensus recommendations. The evidence was graded using the modified Pain Physician criteria and the U.S. Preventive Services Task Force criteria. 

They concluded that Evidence for DRG stimulation for chronic post-operative surgical pain is limited; use should be determined on a case-by-case basis. The USPTF evidence level is III Moderate.

1) The scientific evidence shows health improvement compared to spinal cord stimulation but outcomes data is limited for post-operative chronic pain as opposed to other neuropathic disease states.
2) The device is FDA approved.
3) There is only a small amount of data in chronic post-operative pain patients.
4) The DRG stimulator is not likely to be more beneficial than any other standard treatments/procedures. 

The carrier's denial of a dorsal root ganglion spinal stimulator for the treatment of chronic bilateral low pelvic/groin pain should be upheld.