Very encouraging development on CDIC today - the HFCA essentially mandated their test as the alternative to pulmonary artery catheterization for Medicare patients suffering from congestive heart failure that need inotropic therapy. One of those few cases where the insurers are the good guys - the CDIC test is not only clearly better for the patients but also much cheaper than catheterization. Only losers are the interventional cardiologists and the catheter makers. (This is a big business - 1.5 million of these catheters are sold each year).
Headline: CardioDynamics' Technology Mandated by Medicare as Alternative to Risky Procedure Required for Inotropic Therapy Reimbursement
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Significant Study Demonstrating BioZ(R) Importance in Inotropic Therapy
Presented at This Week's Heart Failure Society Meeting
SAN DIEGO, Sept. 12 /PRNewswire/ -- CardioDynamics International
(NASDAQ:CDIC), manufacturer of BioZ(R) noninvasive digital cardiac function
monitoring systems, today announced that Health Care Financing Administration
(HCFA) has determined the Company's Impedance Cardiography (ICG) technology is
an effective alternative to the invasive pulmonary artery catheter (PAC) in
determining the necessity of intravenous (IV) inotropic infusion therapy in
Medicare's congestive heart failure (CHF) patients. The change in HCFA's
policy mandates that measurements obtained by the BioZ ensure home healthcare
providers, hospital outpatient facilities, congestive heart failure clinics,
and physician offices receive Medicare payments for IV inotropic infusion
therapy. This ruling is paramount for patients and providers inasmuch as the
previously required PAC alternative has associated risks as high as 25%,
including irregular heart beats, infection, and death.
CHF affects nearly five million Americans, with 400,000 new cases
diagnosed annually and ranks among the costliest of cardiovascular disease,
costing the nation an estimated $10 billion annually. Despite recent advances
in pharmacological management of CHF, many patients are unresponsive to
treatment with standard therapy and may require IV inotropic therapy.
Typically, these patients have had to be managed in the hospital but with
technological advances, and now reimbursement, many of these patients can now
be managed in outpatient facilities and their homes. The Journal of
Cardiovascular Management, April 1999 issue, found a greater than 900% cost
savings -- over $5,000 per patient -- when utilizing the BioZ's noninvasive
ICG technology to screen for the necessity of initiating the costly,
intravenous inotropic therapy in CHF patients.
"This is another significant milestone for our proprietary technology,"
stated Michael K. Perry, Chief Executive Officer of CardioDynamics. "HCFA's
inotropic therapy reimbursement ruling is an important step in accelerating
our growth in the outpatient and home healthcare markets. Last year's
favorable HCFA ruling for physician office reimbursement has resulted in
nearly 70% sales growth in this segment alone, and this recent ruling bolsters
physician reimbursement and expands reimbursement and sales to home healthcare
providers. With an estimated 136 million home healthcare visits each year,
the market opportunity is tremendous, and the cost savings of home healthcare
to the $400 billion U.S. annual hospitalization costs is estimated at as much
as $50 billion."
The Company also announced the results of a significant BioZ clinical
study presented by researchers from Michael Reese Hospital, Chicago, and Emory
Hospital, Atlanta, at the Fourth Annual Heart Failure Society (HFSA)
Scientific Meeting in Boca Raton, Florida. The study demonstrated
CardioDynamics ICG technology's importance in successfully evaluating CHF
patients' hemodynamic status, selecting CHF patients who can be discontinued
from intermittent inotropic infusion therapy, and in tailoring the weaning
protocol.
Commenting on the study, Dr. Mary Anne Papp, Director, Heart Failure
Program at Michael Reese Hospital, stated, "The BioZ's noninvasive ICG
measurements reduce and can virtually eliminate the need for an invasive PAC
measurement and are invaluable in patients undergoing inotropic infusion
therapy. The study highlights the importance of ICG data in optimizing
patient care, which translates into improved patient functional status,
decreased emergency room visits, and reduced hospitalizations during short and
long term follow-up (previously published data). ICG technology is fast
becoming a necessity in treating heart failure patients."
Perry added, "HCFA's ruling and this inotropic study validate that the
BioZ's noninvasive hemodynamic measurements assist and guide physicians in
their treatment of this large and costly patient population. Additionally,
the concurrent timing of these two important events will further facilitate
our technology's penetration across the continuum of healthcare."
Peter |
