FDA
Updates Safety Information on CYPHER Stent
The Food and Drug Administration (FDA) recently revised
its warning of sub-acute thromboses (SATs) and hypersensitivity
reactions in patients who received the CYPHER Sirolimus-eluting
Coronary Stent. After reviewing data collected from a mandated
post-approval data registry, FDA officials found that implantation
of the CYPHER stent did not result in higher rates of SATs
when compared to bare-metal stents. A few patients suffered
severe hypersensitivity reactions after implantation of the
stent; these cases were largely attributed to peri-procedural
concomitant medications. Once patients stopped taking the
medications, the reactions subsided. The
FDA continues to approve the CYPHER stent for medical use
in accordance with the labeling instructions.
Presidential
Race Goes Down to the Wire
Political chatter about the 2004 elections
has swelled to a roar as pollsters, pundits and journalists
issue their predictions for a presidential race that many
admit is too close to call. President Bush and Senator Kerry
spent the final week of the campaign courting undecided voters
in key battleground states. With an October Wall Street
Journal Online/Harris Interactive poll showing 42 percent
of American voters are influenced by health care issues, the
candidates continue to emphasize their health care platforms.
In Wisconsin, Bush championed the prescription drug benefit
added to Medicare last year. “Medicare hadn’t
changed, but medicine had,” he explained. “For
example, they pay nearly $100,000 for heart surgery, but not
one dime for the prescription drugs that could prevent the
heart surgery from being needed in the first place.”
During a campaign stop in Iowa, Kerry focused on his plan
to help the uninsured, stating, “We will make health
care a right, not a privilege, for every American.”
Turnout is expected to be high for Tuesday’s election
as states have seen record levels of new
voter registration and absentee ballots have begun to pour
in from abroad.
CMS
Delays 2005 Medicare Physician Fee Schedule Final Rule
Officials from the Centers for Medicare and Medicaid
Services (CMS) missed the Nov. 1 deadline for issuing the
2005 physician fee schedule final rule. Changes to the fee
schedule will take effect on Jan. 1, 2005. It is unclear when
CMS will issue the final rule, but lawmakers have expressed
concern about physicians’ ability to accommodate fee
schedule changes in less than two months. Rep. Nancy Johnson,
R-Conn., voiced her displeasure with the slow process of notifying
physicians about the final reimbursement and drug policy changes
in a statement earlier this month. “I believe doctors
need at least two months to adjust for these changes and to
train their staff,” she said in an Oct. 13 press release.
CMS issued its proposed regulation in July and a summary of
the provisions affecting cardiology are posted on ACC’s
Web site.
Part B News, 10/27/04
Online
Resource: Medicare Discount Drug Cards
Last month, CMS launched a campaign to enroll low-income seniors
in the Medicare prescription drug discount card program. CMS
mailed pre-approved discount cards to 1.8 million seniors
with instructions on how to activate the card and enroll in
the program. To help health care providers answer questions
about this new initiative, CMS has posted an online
resource center with materials
to explain and promote the discount card program to eligible
seniors.
Health
Department Awards Millions in IT Grants
The Department of Health and Human Services recently
awarded $139 million in grants to promote the use of health
information technology (HIT). The grants and contracts are
intended to fund demonstration projects that explore the use
of HIT to prevent medical errors, improve information sharing,
and reduce unnecessary or duplicative testing. Five states
– Colorado, Indiana, Rhode Island, Tennessee and Utah
– received five-year contracts to create and implement
a statewide network to securely share and store patient information.
More than 100 grants were awarded to individuals and organizations
to promote utilization of HIT. To view a state-by-state list
of awarded grants, click
here.
Common
Antibiotic Linked to Heart Attacks
A study published in the September issue of the New
England Journal of Medicine reported that the antibiotic
erythromycin contributed to higher incidence of sudden cardiac
deaths when taken with certain drugs known as CYP3A inhibitors
used to treat infections, high blood pressure, or depression.
Researchers from Vanderbilt University studied 1,476 cases
of sudden cardiac death and found that patients who had taken
both erythromycin and blood pressure medications verapamil
or diltiazem were at a higher risk for cardiac arrest. The
study concluded, “Given that there are alternatives
to erythromycin and to most CYP3A inhibitors, the use of this
combination should be avoided in clinical practice.”
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