Registry is a problem for expanded Medicare ICD coverage.
CMS imposed the registry requirement as part of its September decision to pay for implantable cardioverter defibrillators (ICDs) regardless of QRS interval, and to extend coverage to patients with nonischemic cardiomyopathy. CMS also asked the Heart Rhythm Society (HRS) and the American College of Cardiology to lead a working group to provide recommendations for implementation of the registry. In a November letter to CMS, the HRS and the ACC wrote that it is not possible to finalize the registry by Jan. 1, when the expanded coverage becomes effective.
"Registries have problems because they cost a lot of money, and you don't know how reliable the data are" that go into them, said Stephen C. Hammill, M.D., head of the registry working group, which includes about a dozen people, including representatives from HRS, ACC, and several other clinical societies, as well as registry experts and ICD manufacturers. "If you're entering 60,000 patients a year, that's going to be a lot of expense, both locally for the physician office or hospital that must fill out the data forms, and for whatever organization is running the registry, doing the computer work and the statistical analysis."
There is also the issue of controls. "If you don't have a control population, and you see problems, you're not sure if they're due to the device or a changing population," said Dr. Hammill, president of the HRS and director of heart rhythm services at the Mayo Clinic, Rochester, Minn.
"The way [the working group] hopes to have it designed is that a professional society like the HRS is helping to run the registry, so we're helping to analyze data, look at questions being asked and answered, and working with CMS on it so it's a much more open system," he said.
In the meantime, Dr. Hammill's main concern is that patients continue to get coverage. "It's clear that it will take many months--I don't know if that's 6 months or 12 months--to get this in place. We want to make sure there's a grace period so patients can still receive ICDs while the registry is being set up." CMS has said it will consider the idea, he added.
But when asked, a CMS spokesman did not comment on whether or when the agency will respond to the request, or whether a delay in the registry will also delay the expanded coverage. In fact, the agency "has been working quite successfully with a registry design work group that includes [medical] professionals, industry, and academic experts," and "fully expects" to have the capacity to begin data collection for the registry by Jan. 1, the spokesman told this newspaper.
Since June 2003, CMS has covered ICDs in patients with ischemic dilated car diomyopathy (IDCM), a left ventricular ejection fraction less than 30%, and a QRS interval greater than 120 milliseconds. In September 2004, it expanded coverage to include patients with nonischemic dilated cardiomyopathy (NIDCM) and removed the QRS interval requirement, in response to a request to reconsider its coverage by the ICD maker Medtronic, on the basis of results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).
The SCD-HeFT trial, which involved more than 2,500 patients, looked at whether ICDs improved survival compared with amiodarone or placebo in patients with New York Heart Association class II and class III heart failure and a left ventricular ejection fraction less than 35%. The trial included patients with NIDCM as well as patients with IDCM.
Researchers found that patients with ICDs had 23% lower mortality than did the placebo group, a statistically significant result. The trial also showed that even patients with narrow QRS intervals also obtain a small benefit from ICD therapy, CMS noted in its coverage decision. New coverage criteria will increase the number of beneficiaries eligible for an ICD to nearly 500,000, compared with 385,000 using the original criteria, CMS said.
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|Title Annotation:||Cardiovascular Medicine; Implantable cardioverter defibrillators|
|Comment:||Registry is a problem for expanded Medicare ICD coverage.(Cardiovascular Medicine)(Implantable cardioverter defibrillators)|
|Publication:||Family Practice News|
|Date:||Dec 1, 2004|
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