Posted on 12/15/2011

CHELMSFORD, MASS.–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 wearable defibrillators. 

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, 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, which makes the only wearable defibrillator on the market. “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, and the 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.”

ZOLL's 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. 

SOURCE: ZOLL News Release