Medicare Ruling Concerns Hospital CEOs, but Better Reporting, New Antibiotic Technology Can Lower Cardiac Device Infection Rates

MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--A new Medicare ruling that makes potentially avoidable surgical site infections (SSIs) following cardiac implantable electronic device (CIED) procedures non-reimbursable could have significant financial and quality rating impacts for hospitals, according to a new survey of hospital chief executive officers (CEOs). At the same time, a majority of the CEOs surveyed believed they could influence their electrophysiology/catheterization labs to reduce infection rates, thus managing the risk of higher non-reimbursed costs. Methods cited included leveraging internal reporting to heighten the visibility of CIED SSIs and through the use of antibiotic technologies such as prophylactic antibiotic usage and the AIGISRx^® Antimicrobial Envelope, which is specifically designed to help reduce the risk of CIED infections.

“Surgical site infections have a significant impact on hospitals, both financially and on their quality ratings, which heightened awareness of infection risks and use of preventive technologies can significantly mitigate”

On October 1, “Surgical Site Infection following CIED implantation” became an effective Hospital Acquired Condition (HAC) subject to the Hospital Inpatient Prospective Payment System (IPPS) of The Centers for Medicare and Medicaid Services (CMS). CMS considers such infections to be reasonably preventable and has classified them as complicating conditions that would otherwise result in higher payment to the hospital. Under the new policy, CMS will pay for the original implantation surgery, but will not reimburse hospitals at a higher rate for treating the infection.

The survey polled 50 hospital CEOs at academic health centers and community hospitals across the United States to determine how hospital CEOs viewed HACs and their impact on hospital practices generally, and to understand how hospital practices might change specifically as a result of the new rule concerning CIED-related infections. Findings included:

The top 3 concerns of CEO’s surveyed about the inclusion of CIED-related infections as an HAC were 1) financial impact; 2) impact on quality measures; and 3) infection rates outpacing CIED implant rates.
Nearly 2/3 of CEOs surveyed said their institutions had increased use of antibiotic technology to reduce the incidence of previously designated HACs, such as infections associated with vascular catheter-associated infections or catheter-associated urinary tract infections.
At least 70% percent of CEOs surveyed planned to introduce new technologies to reduce CIED infections, with over 50% citing adoption of the AIGISRx Antibacterial Envelope as an expected practice.
Over 90% planned to use internal reporting to heighten visibility of CIED infections.
Approximately 40% believed their institutions would implant fewer CIEDs in high risk patients because of the new HAC.

Patients with SSIs following CIED procedures spend an average of two extra weeks in the hospital, undergo repeat surgical procedures to treat the infection, and cost the facility an average of $72,485. Additionally, such patients experience significant increases in morbidity and mortality, with 1-year mortality rates of 26.5 – 35.1%, depending on device type.

“Surgical site infections have a significant impact on hospitals, both financially and on their quality ratings, which heightened awareness of infection risks and use of preventive technologies can significantly mitigate,” stated Robert White, President and CEO of TYRX, Inc., the leader in the commercialization of implantable medical devices intended to help reduce SSIs. “New technologies, such as the AIGISRx Antibacterial Envelope, can play an important role in reducing the incidence of such infections and thus lowering hospital costs. 209 high risk patients who received the AIGISRx Envelope had no infections in a recent study conducted by the Vanderbilt Heart and Vascular Institute. This compared to an infection rate of nearly 3% in 671 case matched control patients who did not receive the device.”

About TYRX, Inc.

TYRX, Inc. commercializes innovative, implantable combination drug+device products focused on infection control, including the AIGISRx^® Antibacterial Envelope, designed to reduce surgical site infections associated with Cardiac Implantable Electronic Devices (CIEDs). AIGISRx products contain the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by pathogens responsible for the majority of CIED infections, including “superbugs” such as methicillin-resistant S. aureus (MRSA).*

For more information, please visit www.TYRX.com or www.HeartDeviceInfection.com.

*Data on file at TYRX and published in PACE.2009;32(7):898-907.