Shortchanged: Dollars don’t add up for prothrombin home monitoring
Prothrombin self-testing: where
the lab comes in
Medicare finally began last month to offer reimbursement for home
monitoring of anticoagulation therapy, more than five years after
the FDA cleared the first such devices.
Vendors and patient groups had long pleaded with the Centers for
Medicare and Medicaid Services to cover the home devices since the
majority of those on anticoagulation therapy for heart valves, atrial
fibrillation, and stroke are elderly. By using the devices to measure
prothrombin times weekly, patients can determine if their Coumadin/
warfarin levels are within indicated ranges.
Last September, the CMS said it would begin to cover prothrombin
home monitoring, and in May, it issued the reimbursement guideline,
which took effect July 1. But the reimbursement policy, which covers
only patients with heart valves and requires physicians’ offices,
clinics, or another intermediary to buy the devices, is viewed skeptically
by home testing proponents.
"The format for reimbursement is not very inducive to stimulating
use of this therapy," says Jack Ansell, MD, director of anticoagulation
services at Boston Medical Center and president of the Anticoagulation
Forum. The forum is a network of physicians, nurses, and pharmacists
who advocate improved anticoagulation care through professional
development, education, and research.
Cardiologist Alan K. Jacobson, MD, of Loma Linda (Calif.) Veterans
Hospital, is only slightly more encouraged. "I’m ambivalent about
Medicare’s decision," he says. "It’s good that they’re doing this,"
but the system may be "too complex and too low-paying to make this
Patients on anticoagulation therapy are not organized into an effective advocacy
group, Dr. Jacobson points out. Instead, they’re split among cardiology, hematology,
stroke, vascular surgery, and other specialties. "This is orphan therapy," he
says, "so there has been little political cost in not paying for this."
A diagnostic service
Vendor groups had asked the CMS to cover home prothrombin time
devices as durable medical equipment, like blood glucose monitoring
for diabetics, which means the upfront cost—about $1,500—could
be billed immediately to the agency. "We certainly believed this
was the most logical approach," says Paul Radensky, MD, a Miami-based
lawyer with McDermott Will & Emery, who represents home testing
Instead, however, the CMS elected to cover the devices as a physician-directed
diagnostic service, paid for under the physician fee schedule, or
for hospital-owned clinics, under an ambulatory payment classification
system, rather than under the clinical laboratory fee schedule.
"We had raised concerns under CLIA if this were billed as a clinical
lab service," says Dr. Radensky, "so it became a physician diagnostic
The policy requires the physician, clinic, or other intermediary
who wants to offer the service to buy the device and provide it
to the patient at no charge. The reimbursement fees include a one-time
$100 component for training the patient on how to use the machine,
a continuing technical component of $72 a month for four weekly
tests, and an interpretive professional fee of about $10 a month
for four weekly tests.
Ongoing reimbursement is approximately $82 a month. "This amount
will have to cover physicians’ overhead, which includes the acquisition
of the monitor and the test strips," says David Phillips, an Indianapolis-based
Physicians who manage warfarin patients, largely cardiologists,
must determine if this level of reimbursement is adequate to set
up an infrastructure for home testing. "If they agree with Dr. Ansell,
then this management modality will not be allowed to deliver the
improved anticoagulation management that has been demonstrated in
clinical trials and on which CMS based their reimbursement decision,"
Cardiologists "aren’t in the business of becoming durable medical
equipment suppliers—buying the device, giving it to patients,
refurbishing it, keeping track of it, recovering it when they [patients]
die," says Wayne Powell, director of regulatory and legal affairs
for the American College of Cardiology. "I don’t think the average
physician is going to be very comfortable doing this." Nonetheless,
he adds, at least the CMS is covering the service. "In that regard,
$10 is clearly better than nothing."
One ACC member, John Schaef-fer, MD, president of the North Ohio
Heart Center, Lorain, says he might buy the device for a motivated
patient who pushes for home testing. But he’s not going to do it
as a general rule. With inadequate reimbursement, "it’s not worth
the hassle, the responsibility," he says. "No physician today is
willing to walk out on a limb in financing health care. My costs
are going up and my reimbursement is going down." Until reimbursement
improves, Dr. Schaeffer will continue to send patients to labs for
prothrombin time testing.
The ACC and other interested parties hope to persuade the CMS
to work out the kinks in reimbursement for this covered service
and extend coverage to other groups of patients. "Clinicians, patients,
and industry have worked on this issue with CMS since 1996," says
Phillips. "It isn’t as good as they’d hoped, but the fact that CMS
has issued the payment policy is a significant step."
Phillips says proponents should continue to work with CMS to raise
reimbursement if "the financials just don’t work." If CMS officials
"are genuine in their public statements that home testing can help
Medicare beneficiaries reduce their risk of strokes and bleeding,
then CMS will need to reassess its payment levels and provide adequate
reimbursement to allow physicians to incorporate this into their
practices without losing money and establish reasonable out-of-pocket
costs to the Medicare beneficiary," he says.
McDermott Will & Emery’s Dr. Radensky says how CMS has addressed
prothrombin time testing is unique. "You don’t see another example
of what is, in effect, a home lab test paid for under a physician
fee schedule, where the interpretation and management service payment
doesn’t require a face-to-face visit."
Dr. Radensky says vendors are concerned about the adequacy of
the reimbursement. There’s no track record, he says, because private
payers had covered the testing as durable medical equipment. The
CMS payments "are substantially lower than what we asked for, and
whether or not providers will be willing to do this remains to be
Correspondence from CMS officials indicates they want feedback and will respond
in the 2003 fee schedule, Dr. Radensky says. "They have acknowledged there may
be some problems, but they wanted to get this implemented. We’re very hopeful
that we’ll be able to get payment amounts increased enough to make this viable,"
IDTFs to the rescue?
If physician offices and coagulation clinics balk at the CMS’
reimbursement and refrain from buying the devices, there is one
other possibility. Independent diagnostic testing facilities, or
IDTFs, which are usually for-profit, provide periodic pacemaker
monitoring services for patients and might be willing to take on
prothrombin devices as well.
Since IDTFs already have an infrastructure for interacting with
patients, "it might make sense for them to add this as a service,"
Phillips says. The IDTFs, however, would have to purchase the home
devices and provide them to patients, which they don’t do with pacemakers.
"I just don’t see physicians buying these devices and administering
the program," says Larry Cohen, president of International Technidyne,
Edison, NJ, which sells the ProTime home-monitoring device. "More
likely, the IDTFs and large Coumadin clinics will get into that
Vendors will have to work with the IDTFs to price the machines
appropriately, Cohen says. "IDTFs are accustomed to dealing with
patients on pacemakers, reporting the results, and billing Medicare.
The biggest difference [with prothrombin time devices] is the initial
cost that the IDTF will have to bear."
Hospital-affiliated clinics with enough patients on anticoagulants
may also want to act as an IDTF. "They would have to be progressive
and very high-volume," Cohen says. "Some doctors and clinics are
still wary of self-testing because they see it as a loss of revenue."
But clinics that already embrace point-of-care testing and have
numerous devices might be willing to take on home monitoring that
uses equipment similar to what they already have.
The largest IDTF, Raytel Cardiac Services, Windsor, Conn., has,
however, already written the CMS expressing concern about reimbursement.
"...it is clear to us that only adequate reimbursement codes and
rates will create the necessary support for a successful implementation
of home PT/INR monitoring," says the letter, signed by Raytel president
and CEO Bruce A. Reese.
Reese adds that Raytel has conducted "a detailed assessment of the practice
expense inputs" required to turn prothrombin time testing into an accessible
service. Raytel concluded that the CMS’ proposed reimbursement would make it
impossible to provide "PT/INR monitoring services in keeping with best care
practices." Consequently, "Raytel would, unfortunately, be forced to consider
deferring its entry into this field."
Fighting for reimbursement
Proponents of prothrombin home monitoring campaigned for years
for Medicare reimbursement. Only a fraction (under five percent,
according to the CMS) of the 4 million U.S. patients on warfarin
use home testing, estimates Phillips. About 600,000 of those are
heart valve patients.
Reimbursement has been the No. 1 barrier to home prothrombin time
testing, Phillips adds. With no national policy, the CMS left coverage
to the regional durable medical equipment carriers, who denied all
claims regardless of the circumstances, he says. "Generally, private
insurers made case-by-case determinations based on medical necessity.
The private sector has been more inclined to pay," usually treating
the device as durable medical equipment and paying 80 percent of
Dr. Radensky says after two home testing products, from International
Technidyne and Roche Diagnostics, were approved in early 1997, vendors
and physicians began seeking coverage from Medicare. But in the
absence of national guidance from the top, local carriers "were
denying coverage," he recalls. "Some of the denials were appealed,
but that didn’t change the carriers’ response. They stayed with
the default," which was to deny coverage.
The CMS decided against national coverage in May 1997, based on
recommendations from a committee of physicians and other representatives.
It cited concerns that the studies the panel reviewed "did not conclusively
show improved control of anticoagulation therapy, use of the device
might increase risk in noncompliant or careless patients, and the
device might limit access to regular physician oversight."
Armed with more data, "in 2000 we went back to the CMS coverage
people," says Dr. Radensky. The CMS agreed to do an internal assessment,
which led to the decision last September to provide coverage to
patients with mechanical heart valves.
The CMS concluded: "The evidence for a benefit for home INR monitoring
is clearest for patients with mechanical heart valves ...Although
there were numerous indications, 90 percent of the patients in the
studies reviewed were using the monitor for a mechanical heart valve."
Most of the studies the agency reviewed dealt with patients who
were chronically anticoagulated, such as those using heart valves.
"Although there were a few studies dealing with short-term anticoagulation,
they were not as well-designed, and the benefit of this device for
such patients has not yet been demonstrated," the agency reported.
Says Cohen, of International Technidyne, "It has been an arduous
task to get coverage," even from private insurers. Although 70 to
80 percent of patients who request coverage from private insurers
get it, they and their physicians "have to go through the whole
laborious process." The CMS’ decision might spur private insurers
to more readily offer coverage.
Dr. Ansell, of the Boston Medical Center, agrees with the other experts that
"fixing reimbursement is the most important issue" in boosting acceptance of
home testing. The next issue, he predicts, will be educating physicians and
patients, "but you can’t do that until somebody is willing to pay for the therapy."
Once reimbursement reaches adequate levels, the responsibility for making physicians
"aware and comfortable with home testing" falls on the vendors, he says.
Vendors eye market
The FDA has cleared three devices for home prothrombin time testing:
International Technidyne’s ProTime microcoagulation system, Roche’s
CoaguChek PST system, and LifeScan’s Harmony INR monitoring system.
A fourth device, Inratio by Hemosense, is awaiting FDA clearance,
expected early next year. (Avocet, another company that made such
a device, was acquired by Beckman Coulter.)
Only International Technidyne is marketing its product for home
testing, says Dr. Radensky, who serves as counsel to the prothrombin
time self-testing coalition of ITC, Roche, and Hemosense. The coalition
has worked collaboratively with LifeScan on policy advocacy with
Roche stopped marketing its product because of lack of reimbursement,
but it continues to provide supplies, such as strips and controls,
to its customer base. "The product is available on customer request,"
says Kimberly Ward, marketing manager for coagulation. Now that
the CMS has announced a payment method, Roche is "analyzing the
marketplace and putting a strategy together on how best to approach
the market," she says.
LifeScan, which received clearance for professional and patient
self-testing about a year ago, plans to make the Harmony INR monitoring
system available later this year, says Shari Kipp, senior marketing
manager in LifeScan’s cardiovascular business unit.
Hemosense will follow suit once its device receives the go-ahead
for self-testing. It is already cleared for use by physicians. "We
have been working on reimbursement for years now," says Dale Clendon,
senior vice president of business development for Hemosense. "What’s
come down is between a quarter and a third of what we recommended."
Nonetheless, Hemosense intends to enter the home-testing market.
"We hope this will open up an opportunity for patients to be tested
at home," Clendon says. As that occurs, vendors and physicians will
be able to pressure the CMS to boost reimbursement.
The vendors were coy about disclosing the volume discounts they
might offer physician offices and clinics to induce them to purchase
the products for patients, but they agreed some discounts would
be necessary. "For the vendors, we have to recover the cost of manufacturing
the meters," Clendon says. It’s unclear if vendors can or will lower
their prices enough to induce physicians, clinics, and IDTFs to
provide the service.
LifeScan is encouraged by the CMS’ efforts and that "consideration
was given to physicians for the services they provide in training
and ongoing management," says Robert Knorr, executive director of
LifeScan’s cardiovascular business unit. However, to ensure appropriate
patient access, the "actual implementation needs to be consistent
with FDA and best care guidelines," Knorr says. "The final reimbursement
rates need to fully consider the fundamental differences in use
of available technologies, costs associated with these differences,
and the associated risk with this new care modality."
Despite reimbursement concerns, "we still view this as a big market opportunity,"
says ITC’s Cohen. ITC’s exclusive distributor, QAS (Quality Assurance Systems),
is in the process of becoming an IDTF so it can handle oversight of home testing.
"We manufacturers are going to have to make it attractive for IDTFs to participate,"
he says. "I think we can develop a business model that makes sense for them."
When home testing works
Despite the furor over whether reimbursement levels are adequate,
all parties, including the CMS, agree that home testing benefits
certain groups of patients. Home testing allows greater access to
prothrombin time monitoring, especially for patients in remote or
rural areas. It also makes it possible for patients to test themselves
more frequently and more consistently than if they had to go to
a lab or clinic. "It gives the patient a certain degree of empowerment
and knowledge that may improve compliance" with the anticoagulant
regimen, Dr. Ansell says.
"In the right setting, it’s an ideal opportunity," says Tim Hayes,
MD, chief of clinical pathology at Maine Medical Center, Portland,
and a member of the CAP Coagulation Resource Committee. "In the
wrong setting, it could be quite problematic. You must have compliant,
motivated patients engaged in their illness, who want to get involved
in managing it."
Not all patients on anticoagulants are capable of self-testing.
In its coverage policy announcement, the CMS wrote: "The use of
these devices requires some manual dexterity and an ability to follow
instructions . . . The patient should also have demonstrated an
ability to follow a physician-derived algorithm relating to dosing
"The ideal candidates," says Dr. Ansell, "are patients with an
understanding of their therapy and a willingness to do home testing.
They must also be mentally alert." Self-test patients also need
access to a physician’s office or clinic that can respond quickly
if the prothrombin tests show an abnormal reading. Many facilities
use an anticoagulation nurse who can advise patients on dosing.
Dr. Jacobson, of the Loma Linda VA, believes home therapy could
improve compliance by keeping Cou-ma-din/ warfarin within recommended
"The biggest issue in coagulation management is getting the prothrombin
tests done," he says. For many patients, home testing is the answer.
"Our estimate is that about 70 percent of our patients are interested
in this and capable of doing it," he adds. Yet only about 200 of
his 1,000 patients are undergoing home testing, and most are doing
so under research protocols where the vendor pays for the device.
More clinics and hospitals would offer home testing, he says, "if
they could figure out a way to make money doing it."
Karen Southwick is a writer in San Francisco.