In the coming months, you will be hearing more about The Centers for Medicare and Medicaid Services (CMS) using Recovery Audit Contractors (RACs)¹ for recovering “inappropriate payments” for Medicare services. CMS is expanding the use of RACs from a limited demonstration program in a few selected states to a national rollout that will be completed by 2010. This article is intended to provide you with some background as to what RACs are, what they are intended to do, and what actions you should consider to prepare for their upcoming national rollout.

Background

Although CMS has reported a declining error rate in paid claims over the past five years due to significant compliance efforts, a January 2008 report by the Office of Management and Budget (OMB) indicated that Medicare is still among the top three Federal programs with improper payments, totaling an estimated $10.8 billion in 2007.

For Identifying Patients at Risk for Sudden Cardiac Death

A scientific statement on the findings for use of noninvasive risk stratification techniques for identifying patients at risk for sudden cardiac death (SCD) was recently published.1

Sudden cardiac death has been defined as a death due to cardiovascular causes, within an hour after symptom onset, and occurring outside the hospital, in the emergency room, or as a DOA at hospital arrival. A variety of risk stratification techniques have been developed over the past 30 years with the goal of trying to predict which patients are more likely to develop SCD. The techniques generally focus on prediction of reversible ventricular arrhythmias. The risk stratification techniques reviewed for this scientific statement focused on ischemic, dilated and hypertrophic cardiomyopathies.

What is the size of your EP lab facility and number of staff members? What is the mix of credentials at your lab?
We have one EP lab, with a second under construction, and two procedure rooms. We have nine staff members and a working supervisor. There are seven full-time and two part-time staff members, with one PRN staff member who helps out with vacations and time off. Two of our staff are IBHRE-certified in EP.
In total, we have seven RNs, two LPNs and one RT.

When was the EP lab started at your institution?
We started in 1984 in a small room at the end of the ICU. In the beginning, we used reams and reams of paper on the VR 16. Only the older EP people will remember that huge machine! In 1992, we became a dedicated EP lab and continue to be so today. One of our employees who worked in the EP lab in 1984 is still working with us.

What types of procedures are performed at your facility?

The purpose of the TRUST (Lumos-T Safely Reduces Routine Office Device Follow Up) study is to test whether remote monitoring is safe and effective for ICD follow up. In this feature interview, we speak with Dr. Niraj Varma, TRUST principal investigator, Cleveland Clinic.

Tell us about the TRUST Study. What was the purpose of this study?
The study endpoints are designed to show that with BIOTRONIK’s Home Monitoring (HM) technology, office visits for patients can be reduced without compromising the well-being of the patients, and at the same time facilitate early detection of significant clinical problems. The obvious benefit of this is a reduction in the clinic load for the physician, as well as decreasing the hassle of coming into the office for the patients.

Is enrollment complete? How many patients were enrolled? What was the patient inclusion criteria?

Medtronic Data Presented at American Heart Association Scientific Sessions 2008 Supports Utility of Painless Pacing Therapies in ICD Patients

New data presented at Scientific Sessions 2008 from Medtronic shows that survival among patients with implantable cardioverter defibrillators (ICDs) treated only with anti-tachycardia pacing (ATP) was superior to patients who experienced at least one shock-treated episode, further demonstrating the clinical benefit of ATP. Additionally, the analysis evaluating more than 2,000 patients found no link between inappropriate therapy and mortality, nor a causal relationship between ICD therapy (ATP or shock) and mortality.

ATP allows most patients with ICDs to receive painless pacing pulses to safely and effectively terminate dangerous ventricular tachyarrhythmias.

In this interview we speak with Eric Le Royer, CEO of Endosense, about the TOCCATA (TOuCh+ for CATheter Ablation) clinical study. The purpose of this ongoing study is to evaluate the safety of the TactiCath for the treatment of atrial arrhythmias.

Tell us about the TactiCath force-sensing catheter. What makes it unique from other ablation catheters?

What makes it unique is the fact that the force-sensing technology is embedded in an ablation catheter, at the very tip of the catheter. The force sensor allows the electrophysiologist to accurately sense in real time the force of the catheter against the cardiac wall during an ablation procedure with high precision. The electrophysiologist is able to ensure the right amount of force exerted during the ablation procedure.

What are the benefits of a such a catheter?

There are numerous ongoing clinical trials on atrial fibrillation (AF) currently taking place. Included is a brief listing of updated AF trials for 2008.

An Observational Study to Assess the Efficacy of Continuous Sub-cutaneous Arrhythmia Monitoring Versus Conventional Ambulatory ECG Monitoring in Detecting Atrial Fibrillation in Patients After Pulmonary Vein Isolation

Number of Patients: 50

Trial Start Date: June 2008

Estimated Completion Date: January 2011

Status: Recruiting

Purpose: The primary aim of this diagnostic, open label study is to assess the efficacy of continuous rhythm monitoring with an implantable loop recorder (ILR) compared to conventional ambulatory electrocardiography in detecting episodes of AF after pulmonary vein isolation (PVI). The secondary purpose is to assess the efficacy of PVI during a two-year follow-up and to assess the reliability of the ILR in detecting AF.

In a new study, entitled "Epidemiology and Outcomes in Patients with Atrial Fibrillation in the USA," warfarin was found to be significantly underused in patients with atrial fibrillation. The study, led by Drs. Alexander Walker and Dimitri Bennett, was published in the October 2008 edition of the HeartRhythm Journal.1 In this interview, we speak with them about the study findings.

Tell us a little about warfarin therapy. What are the benefits of warfarin for atrial fibrillation (AF) patients?

Patients with atrial fibrillation often form thrombi, or blot clots, in the atrium, which is not beating effectively. These clots can break off to form emboli, causing stroke. Warfarin inhibits the clotting process, and therefore, reduces the risk of thromboembolism including stroke.

What were your reasons for doing this study analysis? Describe the study design.

Background

A 53-year-old male presented with syncope, palpitations, untreated hypertension and possible Wolff-Parkinson-White syndrome. There was no evidence of diabetes or other chronic illness. Although the EP study results were negative, the patient had experienced palpitations and syncope clinically.

Since the patient worked as an operator of heavy machinery for construction, he expressed concern that he would no longer be able to run a bulldozer and retain his job. Therefore, the patient was referred for an implantable cardiac monitor implant for further analysis.

Implantable ECG Monitoring System

It’s been a busy year for EP Lab Digest’s discussion group — I truly appreciate all of the help of those who participated! Unfortunately, there were also some questions that did go unanswered in 2008; take a look at the questions below and let us know if you can help answer any of them!

You can respond by emailing us at eplabdigest@hotmail.com or visiting us online at www.eplabdigest.com. Remember, when responding to the discussion group, don’t forget to let us know if you would like your name and/or location listed.

From February 2008: Inventory/Charging

Does any lab use technology (bar coding, cabinets, etc.) to help them with their catheter and equipment inventories and charges? What technology, and how well does it work for you? Any input would be helpful. Thanks!

— Dale R. Beatty, RN
(To reply to this question, please type Inventory/Charging in your subject line.)