ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that the Centers for Medicare and Medicaid Services (CMS) Durable Medical Equipment Medical Administrative Contractors (DME MACs) reaffirmed the current coverage policy across all indications for the LifeVest® Wearable Defibrillator.
CMS coverage for wearable defibrillators was established in 2005. In August, 2011, the DME MACs considered changes to the Medicare coverage for the wearable cardioverter defibrillator (WCD) as part of a draft Local Coverage Determination (LCD) for Automatic External Defibrillators (AEDs).
During the public comment period, the current coverage policy received broad and overwhelmingly positive support from all of the key cardiology‑focused professional societies, including the Heart Rhythm Society, American College of Cardiology, American Heart Association, American Association of Heart Failure Nurses, Sudden Cardiac Arrest Association, and the Sudden Cardiac Arrest Foundation. In addition, over 50 nationally recognized physicians submitted comments supporting CMS coverage for WCDs in the implantable cardioverter defibrillator (ICD) waiting periods.
The DME MAC Medical Directors withdrew the draft LCD, making no changes to the current LCD as it relates to WCDs. This policy is consistent with the coverage criteria that over 3,000 private insurance plans and 37 state Medicaid plans use to evaluate and reimburse for the WCD in these periods.
“We are pleased with the decision by the DME MAC Medical Directors. After their thorough review of all available research and literature, the Medical Directors decision reaffirms the wisdom of the current, original Medicare policy initiated in 2005 that wearable defibrillators are medically necessary to protect patients at risk of sudden cardiac death during ICD waiting periods. The decision highlights that wearable defibrillator therapy delivers both the quality of patient care and the economic value that payers are seeking.” said Richard A. Packer, Chief Executive Officer of ZOLL. “I believe the favorable DME MAC decision represents a significant milestone in broader wearable defibrillator therapy coverage policy—the significant, robust comments supporting the current policy during the public comment period, including letters from the Heart Rhythm Society, American College of Cardiology, American Heart Association, American Association of Heart Failure Nurses, Sudden Cardiac Arrest Association, Sudden Cardiac Arrest Foundation, and over 50 nationally recognized, thought-leading physicians, raises the expectation for private payers to provide similar coverage, enabling more physicians to cost effectively save more lives.”
The LifeVest is worn by patients at risk for sudden cardiac arrest (SCA), providing protection during their changing condition and while permanent SCA risk has not been established. The LifeVest allows a patient’s physician time to assess his or her long-term arrhythmic risk and make appropriate plans. The LifeVest is lightweight and easy to wear, allowing patients to return to their activities of daily living, while having the peace of mind that they are protected from SCA. The LifeVest continuously monitors a patient’s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart rhythm.
The LifeVest is used for a wide range of patient conditions or situations, including following a heart attack, before or after bypass surgery or stent placement, as well as for those with cardiomyopathy or congestive heart failure that places them at particular risk.
About ZOLL Medical Corporation
ZOLL Medical Corporation (zoll.com) develops and markets medical devices and related software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, fluid resuscitation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies which help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and critical care.
A NASDAQ Global Select company and a Forbes 100 Most Trustworthy Company in 2007, 2008 and 2009, and a Forbes Top 100 Small Business Company in 2011, ZOLL develops and manufactures its products in the United States, in California, Colorado, Illinois, Massachusetts, Pennsylvania, and Rhode Island. More than 400 direct sales and service representatives, 1,100 business partners, and 200 independent representatives serve our customers in over 140 countries around the globe.
Certain statements contained in this press release, including statements regarding the Company’s expectations of private payer reimbursement for our LifeVest product, and other statements contained herein regarding matters that are not historical facts, are “forward-looking” statements (as defined in the Private Securities Litigation Reform Act of 1995). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those factors discussed in the section entitled “Risk Factors” in the Company's Annual Report on Form 10-K filed with the SEC on November 23, 2011 and subsequent filings. You should not place undue reliance on the forward-looking statements in this press release, and the Company disavows any obligation to update or supplement those statements in the event of any changes in the facts, circumstances, or expectations that underlie those statements.
© 2011 ZOLL Medical Corporation. All rights reserved. 269 Mill Road, Chelmsford, MA 01824-4105. LifeVest and ZOLL are registered trademarks of ZOLL Medical Corporation. All trademarks are property of their respective owners.
A. Ernest Whiton, Chief Financial Officer
ZOLL Medical Corporation
P: +1 (978) 421-9655