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Devices & Diagnostics Letter
June 16, 2003
SECTION: Vol. 30, No. 24
LENGTH: 683 words
HEADLINE: INCREASED COVERAGE OF ICDs NOT ENOUGH TO SATISY INDUSTRY
BODY:
Although the Centers for Medicare & Medicaid Services (CMS) has expanded
national coverage for implantable cardioverter defibrillators (ICDs),
devicemakers are not entirely pleased because the policy does not cover all
heart attack survivors.
In a decision summary, CMS said there was not enough evidence to conclude
that an ICD implant is reasonable and necessary for all Medicare beneficiaries
with a prior myocardial infarction.
This view differs dramatically from that of Guidant, which submitted a
request for expanded coverage in May 2002. The company said its Multicenter
Automatic Defibrillator Implantation Trial (MADIT II) clearly demonstrates a
significant reduction in mortality rates among all patient populations implanted
with the device.
The company backed up its claim with data from a trial designed to determine
whether the ICD, in conjunction with optimal drug therapy, prevented more deaths
than drugs alone in survivors with moderate impairment of the left ventricular,
the heart's main pumping chamber.
To be included in the MADIT II study, which enrolled 1,232 patients at 71
U.S. centers, patients had to:
* Be male or female, 21 years old or older;
* Have had one or more myocardial infarctions three weeks or more prior to
enrollment; and
* Demonstrate left ventricular ejection fraction (proportion of blood pumped
out of the heart with each beat) of less than or equal to 30 percent.
Guidant's request sought increased coverage of the implants to match the
inclusion criteria of the MADIT II study. But in a decision memorandum issued
earlier this month, CMS said it would limit coverage of the implants to patients
with:
* A documented episode of cardiac arrest due to ventricular fibrillation
(VF), not due to a transient or reversible cause;
* Documented sustained ventricular tachyarrhythmia, either spontaneous or
induced by an electrophysiology (EP) study, not associated with myocardial
infarction and not due to a transient or reversible cause;
* Documented familial or inherited conditions with a high risk of
life-threatening ventricular tachyarrhythmias, such as long QT syndrome or
hypertrophic cardiomyopathy;
* Coronary artery disease with a documented prior myocardial infarction, a
measured left ventricular ejection fraction of less than 0.35, and inducible,
sustained ventricular tachycardia or VF during EP study. (The myocardial
infarction must have occurred more than four weeks prior to implantable
defibrillator insertion. The EP test must be performed more than four weeks
after the qualifying myocardial infarction.); and
* A determination from CMS that the evidence is adequate to conclude that an
implantable defibrillator is reasonable and necessary for patients with a
documented prior myocardial infarction and a measured left ventricular ejection
fraction < 0.30 and a QRS duration of > 120 milliseconds.
"Best medical science and evidence-based medicine signals that this coverage
stops short of that which is warranted," said Fred McCoy, president of Cardiac
Rhythm Management at Guidant. "The scientific evidence convincingly demonstrates
that, in patients who met the MADIT II criteria, ICDs offer life-saving
benefits."
CMS said the decision to limit coverage was partially based on a key question
posed before the Medicare Coverage Advisory Committee during a meeting in
February. The panel unanimously voted "no" when asked if the evidence is
adequate to apply the findings of the MADIT II trial to all Medicare patients
with a prior myocardial infarction and an ejection fraction of .3 without
requiring evidence of an arrhythmia.
"While the MADIT II trial was a good randomized trial, it is a single
clinical trial with a number of potential significant methodological
limitations," CMS said. "The evidence is not currently adequate to conclude that
implantable defibrillator therapy is reasonable and necessary for the entire
population of MADIT II eligible criteria."
CMS said it will reconsider its conclusions when additional data from risk
stratification studies and other trials become available.
LOAD-DATE: June 23, 2003
Devices & Diagnostics Letter
June 16, 2003
SECTION: Vol. 30, No. 24
LENGTH: 683 words
HEADLINE: INCREASED COVERAGE OF ICDs NOT ENOUGH TO SATISY INDUSTRY
BODY:
Although the Centers for Medicare & Medicaid Services (CMS) has expanded
national coverage for implantable cardioverter defibrillators (ICDs),
devicemakers are not entirely pleased because the policy does not cover all
heart attack survivors.
In a decision summary, CMS said there was not enough evidence to conclude
that an ICD implant is reasonable and necessary for all Medicare beneficiaries
with a prior myocardial infarction.
This view differs dramatically from that of Guidant, which submitted a
request for expanded coverage in May 2002. The company said its Multicenter
Automatic Defibrillator Implantation Trial (MADIT II) clearly demonstrates a
significant reduction in mortality rates among all patient populations implanted
with the device.
The company backed up its claim with data from a trial designed to determine
whether the ICD, in conjunction with optimal drug therapy, prevented more deaths
than drugs alone in survivors with moderate impairment of the left ventricular,
the heart's main pumping chamber.
To be included in the MADIT II study, which enrolled 1,232 patients at 71
U.S. centers, patients had to:
* Be male or female, 21 years old or older;
* Have had one or more myocardial infarctions three weeks or more prior to
enrollment; and
* Demonstrate left ventricular ejection fraction (proportion of blood pumped
out of the heart with each beat) of less than or equal to 30 percent.
Guidant's request sought increased coverage of the implants to match the
inclusion criteria of the MADIT II study. But in a decision memorandum issued
earlier this month, CMS said it would limit coverage of the implants to patients
with:
* A documented episode of cardiac arrest due to ventricular fibrillation
(VF), not due to a transient or reversible cause;
* Documented sustained ventricular tachyarrhythmia, either spontaneous or
induced by an electrophysiology (EP) study, not associated with myocardial
infarction and not due to a transient or reversible cause;
* Documented familial or inherited conditions with a high risk of
life-threatening ventricular tachyarrhythmias, such as long QT syndrome or
hypertrophic cardiomyopathy;
* Coronary artery disease with a documented prior myocardial infarction, a
measured left ventricular ejection fraction of less than 0.35, and inducible,
sustained ventricular tachycardia or VF during EP study. (The myocardial
infarction must have occurred more than four weeks prior to implantable
defibrillator insertion. The EP test must be performed more than four weeks
after the qualifying myocardial infarction.); and
* A determination from CMS that the evidence is adequate to conclude that an
implantable defibrillator is reasonable and necessary for patients with a
documented prior myocardial infarction and a measured left ventricular ejection
fraction < 0.30 and a QRS duration of > 120 milliseconds.
"Best medical science and evidence-based medicine signals that this coverage
stops short of that which is warranted," said Fred McCoy, president of Cardiac
Rhythm Management at Guidant. "The scientific evidence convincingly demonstrates
that, in patients who met the MADIT II criteria, ICDs offer life-saving
benefits."
CMS said the decision to limit coverage was partially based on a key question
posed before the Medicare Coverage Advisory Committee during a meeting in
February. The panel unanimously voted "no" when asked if the evidence is
adequate to apply the findings of the MADIT II trial to all Medicare patients
with a prior myocardial infarction and an ejection fraction of .3 without
requiring evidence of an arrhythmia.
"While the MADIT II trial was a good randomized trial, it is a single
clinical trial with a number of potential significant methodological
limitations," CMS said. "The evidence is not currently adequate to conclude that
implantable defibrillator therapy is reasonable and necessary for the entire
population of MADIT II eligible criteria."
CMS said it will reconsider its conclusions when additional data from risk
stratification studies and other trials become available.
LOAD-DATE: June 23, 2003
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