CARDIOVASCULAR JOURNAL OF AFRICA • Vol 22, No 5, September/October 2011
280
AFRICA
Expanded coverage for warfarin patients in the USA monitoring
clotting time at home
Decision makes convenient self-testing a financial reality for more patients on anticoagulants
Medicare will now cover and pay for
meter training, equipment and supplies
for all long-term warfarin users in the
USA who monitor their prothrombin
time at home with a portable handheld
meter. The change opens the door to
greater convenience and potentially fewer
complications for a broader spectrum of
anticoagulation patients.
Medicare previously reimbursed these
expenses for only self-testing patients
who had mechanical heart valves. The
new coverage expands to include those
on anticoagulant medication with chronic
atrial fibrillation and venous thromboem-
bolism.
‘This expanded coverage will give
more warfarin patients the flexibility to
test when and where they want to’, said
Dr Alan Jacobson, cardiologist, Loma
Linda University School of Medicine.
‘Now, patients who travel extensively or
who have difficulty with access to their
doctor’s office or a centralised location
can monitor their INR at home. If they
test more often, it’s easier to manage their
therapy and keep their medication in the
therapeutic range.’
Some patients travel to their doctor’s
office or an anticoagulation clinic as often
as once a week to make sure their warfarin
is appropriately regulated. While warfarin
is commonly prescribed to prevent throm-
bosis, or blood clots, it must also be care-
fully monitored to prevent bleeding.
Portable, handheld prothombin time
(PT/INR) meters, such as the CoaguChek
(R) XS system for patient self-testing,
enable patients to test their clotting time
at home in about a minute, using a small
drop of blood from a simple fingerstick.
Currently, in the United States, less than
5% of patients on blood thinners perform
self-testing, according to the Centers for
Medicare and Medicaid Services.
Studies suggest that anticoagulation
patients who self-test may experience
fewer complications overall than thosewho
do not, because self-testing may increase
patient time in the therapeutic range.
1
Studies also suggest that PT/INR self-
testing (performed with a blood sample
from a fingerstick) is just as accurate as
fingerstick testing performed by a health-
care professional and conventional testing
performed on a laboratory analyser.
2-4
‘I feel comfortable with more of my
patients monitoring from home because
handheld meters such as the CoaguChek
XS system are easy to use, and I know the
results will be as reliable as results from
our office meter and from the lab’, said
Dr Jacobson. ‘Plus, this gives my patients
the convenience of testing at home with
a simple fingerstick rather than having
blood drawn from their arm and waiting
for lab results.’
Under the new Medicare B policy, the
patient portion of costs for self-testing is
expected to be about $30 a month (based
on a national average) for the use of a
PT/INR meter and test strips, and about
$35 for the initial training. Patients with
supplemental insurance coverage could
potentially have little or no out-of-pocket
expenses.
All patients on anticoagulant medica-
tion need a prescription from their doctor
for a self-testing meter and supplies
before being able to monitor their own
clotting time at home. Patient self-testing
is also designed to augment, not elimi-
nate, testing and therapy management
that is overseen by a doctor. Patients who
self-test notify their doctors of clotting-
time results so they can make the proper
adjustments to their medication.
Patients interested in finding out
more about self-testing their PT/INR
should talk to their doctor. For more
information on the CoaguChek XS
system for patient self-testing, visit www.
ASmartWayToTest.com.
About anticoagulation monitoring
Certain patients with atrial fibrillation,
a mechanical heart valve or deep-vein
thrombosis require protection against
thrombosis. They are typically put on
lifelong oral anticoagulation therapy with
warfarin sodium (e.g. Coumadin) to thin
their blood. Each patient reacts differ-
ently to anticoagulant medications, so it is
imperative to monitor therapeutic effects
closely to minimise potential risks.
About CoaguChek products
Physicians have been using CoaguChek
instruments for point-of-care PT/INR test-
ing since 1994. Today, in the USA, more
point-of-care PT/INR tests are performed
with a CoaguChek system than with all
other devices combined.
5
The CoaguChek
XS system represents the fifth generation
of point-of-care anticoagulation monitor-
ing devices from Roche Diagnostics.
1.
Kortke H, Minami K, Breymann T,
et al
.
INR self-management after mechanical
heart valve replacement: ESCAT.
Z Kardiol
2001;
90
(6): 118–124.
2.
CoaguChek XS system package insert.
Indianapolis, IN. Roche Diagnostics
Corporation; 2006.
3.
Bussey HI, Chiquette E, Bianco TM,
et al
.
A statistical and clinical evaluation of finger
stick and routine laboratory prothrombin
time measurements.
Pharmacotherapy
1997;
17
(5): 861–866.
4.
Kaatz SS, White RH, Hill J,
et al.
Accuracy
of laboratory and portable monitor inter-
national normalized ratio determinations.
Comparison with a criterion standard.
Arch
Intern Med
1995;
155
: 1861–1867.
5.
Second quarter 2007 total market share of
projected distributor unit sales of the point-
of-care testing coagulation reagents and kits.
tional in-office follow up.’
The EVATEL study included 1 501
patients with ICDs from 30 centres in
France. They were enrolled between 2008
and 2010 and each was followed for a
year. The primary endpoint of the study
was a composite of death from all causes,
cardiovascular hospitalisation, and inef-
fective or inappropriate therapy delivered
by the device.
Of patients seen every three months at
an implant centre, 28.5% met the primary
endpoint, compared with 30.2% of those
followed remotely. There were no statis-
tically significant differences between
the two groups in one-year survival, or
the time to the first primary endpoint.
Remote patients received fewer inappro-
priate therapies than controls.
