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MEDICARE COLLABORATES TO HELP DOCTORS AND PATIENTS USE IMPLANTABLE DEFIBRILLATORS EFFECTIVELY

Medicare will work with the American College of Cardiology to collect data nationwide to help learn more about the use of implantable cardioverter defibrillators (ICDs) for primary prevention of sudden cardiac death among Medicare beneficiaries, Centers for Medicare & Medicaid Services Administrator Mark B. McClellan, M.D., Ph.D., announced today.

As a result of the contract, the American College of Cardiology’s National Cardiovascular Data Registry’s (ACC-NCDR) ICD Registry™ will become the new repository of information from more than 1,300 hospitals nationwide, effective April 1, 2006 . The registry was created by a partnership between the American College of Cardiology and the Heart Rhythm Society, and has support from the ICD manufacturing industry, private health plans and payers, and hospital groups. 

“CMS is pleased to contract with ACC-NCDR to help develop new evidence to improve care for Medicare beneficiaries who may be at risk of sudden cardiac death,” Dr. McClellan said.  “Through our coverage process, we are providing greater access to a potentially lifesaving treatment and greater support for doctors and patients to use this treatment effectively.”

“The ICD Registry™ will undoubtedly lead to huge benefits for all health care stakeholders, but more importantly to our ICD patients and their families," said Ralph G. Brindis, M.D., F.A.C.C., ACC-NCDR Management Board Chair.

In January, CMS announced it would expand Medicare coverage of ICDs based on results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), sponsored by the National Institute of Health’s  National Heart, Lung and Blood Institute.  The January 2005 decision increased the number of Medicare beneficiaries eligible for an ICD by one-third to nearly 500,000, and required hospitals to submit data to an ICD registry as a criterion of coverage.   Since the decision, CMS has been gathering data using its  QNet platform, which the agency also uses to collect other data on healthcare quality.

CMS plans to utilize ICD Registry™ data, combined with that gathered through QNet, to answer the clinical questions posed in its January 2005 decision memorandum, such as whether the indications for ICD implantation in the Medicare population is similar to the patients who received ICDs in the SCD-HeFT and other trials.

In   addition, other data from the ICD Registry™ will help analysts answer several key questions about ICD implantation, including how frequently the devices stabilize the electrical activity of the heart in different subgroups of patients.  This question could only be definitively established for a subset of patients in SCD-HeFT, who clearly benefited from use of the device.

However, the evidence on benefits of ICD implantation in certain subgroups was not as strong, and it is important for doctors to get better evidence on the use of these devices for these patients as well.  Many Medicare beneficiaries are older than the patients studied in SCD-HeFT, and many others who are at high risk of cardiac events do not closely match the characteristics of the group in which there was a clear benefit.

Other questions can also be addressed with the registry data, such as whether cardiac morbidity and mortality differ among patients based on clinical characteristics, device characteristics, the facility and/or the physician who implants the device.

“These efforts are a part of CMS’ Coverage with Evidence Development initiative, which helps ensure that patients receive access to important treatments while facilitating the collection of evidence so that doctors and patients are able to get the most benefits with the least side effects,” Dr. McClellan said.  “The Medicare aggregate data from the ICD Registry™ will be made available to the public to better inform patients and physicians on the most appropriate ICD therapy.  Better evidence means better decisions by doctors and patients.”

CMS will require hospitals to transition their current ICD data reporting activities from Quality Network Exchange ICD Abstract Tool (QNET) and to begin submitting data about their procedures to the ICD Registry™. This transition must be completed by April 1, 2006 .

"I am pleased CMS will contract with the ACC and HRS for the next phase of the National ICD Registry™. By replacing QNET with the ACC/HRS ICD Registry™, CMS has made data entry more convenient to providers.  The ICD Registry™ will allow the medical community to assess if quality outcomes are being achieved for ICD patients, determine if appropriate patients are receiving the devices, and have the potential to play an important role evaluating device performance," said Stephen C. Hammill, M.D., F.A.C.C., immediate past president of Heart Rhythm Society, National ICD Registry™ Working Group Chair.

To ensure that hospitals can begin using the ICD Registry™ before the ICD Abstraction Tool sunsets, hospitals must contact ACC-NCDR no later than January 1, 2006 to begin the enrollment process.

More information about the ICD Registry™ can be found at https://www.accncdr.com or by calling the American College of Cardiology toll-free at 1-800-253-4636, extension 451.