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Medicare to Collect Data on Use of Implantable
Defibrillators
ICD coverage by Medicare was expanded in January
Oct. 27, 2005 - Medicare, which expanded coverage
of implantable cardioverter defibrillators (ICDs) for primary prevention
of sudden cardiac death in January, announced today it will work with
the American College of Cardiology to collect data nationwide to help
learn more about the use of ICDs.
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
Healths 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.
Todays announcement was made by Centers for
Medicare & Medicaid Services Administrator Mark B. McClellan, M.D.,
Ph.D.
As a result of the contract, the American College
of Cardiologys National Cardiovascular Data Registrys (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.
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.
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