College of American Pathologists
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  Prodding CMS on warfarin home monitoring





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February 2007
Feature Story

Ed Finkel

Nearly five years ago, the Centers for Medicare and Medicaid Services (CMS) began providing coverage for home monitoring of levels of Coumadin/warfarin activity in mechanical heart valve patients. Now, home-monitoring proponents are collecting evidence and gearing up to advocate that the CMS expand coverage eligibility to atrial fibrillation patients and others.

At the same time, the Patient Self-Testing, or PST, Coalition, a group of manufacturers of point-of-care coagulation systems (Hemosense Inc., International Technidyne Corp., and Roche Diagnostics Corp.), is playing defense as the CMS aims to cut the rates of reimbursement this year for those who prescribe PT/INR home monitoring.

The coalition’s current best estimate is that 910 new mechanical heart valve patients filed claims with the CMS for home monitoring in 2005, the most recent year for which data are available, and that no more than 2,000 total patients are doing so, says Paul Radensky, MD, JD, counsel to the coalition and attorney with the Miami office of law firm McDermott, Will & Emery, LLP.

“It’s still a fairly select group. We’re not 100 percent sure what the utilization is,” he says. “Familiarity among physicians is low. A number of the clinics have told us that if the coverage policy was broadened, they would be more encouraged to refer patients for home monitoring, but because the policy is so narrow, their enthusiasm is very limited. You want to know you have a critical mass of patients.”

“The adoption curve has been relatively slow,” agrees Larry Cohen, president of International Technidyne. “A physician doesn’t want to just single out the heart valve patients for home testing. They also don’t want to manage their patients selectively. They’d like to do it as a group. That means all of their Coumadin patients who are capable of home testing.”

Cohen calls it a work in progress. “There’s still a small number of patients being tested at home. It’s grown, and it’s a healthy growth rate, but we all would have thought that by now it would have had a much higher adoption rate.” But he’s not without hope. “I still think [the market] will develop,” he says.

Randy Pritchard, director of product marketing at Roche Diagnostics, maker of CoaguChek products, says, “Adoption of PST is difficult as health care professionals want to ensure the safety of their patients on warfarin therapy when testing is done in the home. And unfortunately, the private costs to allow for PST have also been a barrier to its growth.”

The CMS made its initial July 2002 determination that restricted coverage to mechanical heart valve patients based on the literature available at the time. Much of that originated in Germany and focused on results in heart valve patients, Dr. Radensky says. But atrial fibrillation is the most common reason for prescribing warfarin, and other conditions like blood clots also warrant its use, he says.

“A large part of the population is not covered by the Medicare national coverage determination. . . . A number of experts told CMS that there was not a good clinical reason for [limiting coverage] based on the underlying reason for warfarin, but CMS decided not to follow their recommendations,” Dr. Radensky says.

The CMS had certain criteria in mind: a randomized, controlled trial, published in a peer-reviewed journal. It found seven such studies focused primarily on mechanical heart valve patients but not a “critical mass” on other indications, says David Phillips, vice president of marketing for HemoSense.

Self-testing got its start in Germany in the mid-1980s, Phillips says, and continues to be widely prescribed there. “The way things evolved, it tended to be more heart valve patients because of the way the German model was set up.”

New implanted heart valve patients in Germany typically are sent from an acute care hospital to a rehabilitation center, where they remain to recuperate and become educated on healthy lifestyles to avoid further problems, Phillips says. Those who wish to self-dose with warfarin once they leave, rather than make repeated appointments to have it administered to them, are trained in how to do so.

“That got started, and the provider was reimbursed 100 percent—the monitor, test strips, and the training,” he says. “That made it easier for the provider to adopt this method of management. Additionally, they were training patients to do self-dosing, like a diabetic would do in the U.S. That model in Germany has continued to date.”

The resulting steady flow of self-managed patients provided plenty of subjects for the studies that the CMS relied on, Phillips says. “Which led to the conclusion that CMS would support coverage for mechanical heart valve patients,” he says.

Since that time, additional studies have focused on patients who need warfarin for reasons other than mechanical heart valves, or on mixed populations of patients, and the coalition plans to present those data to the CMS later this year, Dr. Radensky says. “We’ve been culling those data and have had some informal discussions with CMS,” he says.

Among the more potent evidence the coalition plans to bring forward is a meta-analysis of 14 studies published in Lancet in February 2006, along with several of the underlying studies the article cites, Phillips says. “We will go back to CMS and say, ‘There’s newer information, more data, that should be reviewed that we believe is compelling and should support your coverage expanding to include A Fib.’”

Expanding the CMS’ reimbursement would create a market of perhaps a million people or more, Cohen says. “It’s a cross-section of different conditions people have that cause them to take Coumadin or warfarin. All of these studies show the same thing, which is basically that patients who manage their therapy themselves have better outcomes.” They can monitor themselves more frequently, and their outcomes are better, measured by fewer adverse events such as bleeding and significant reductions in thromboembolic events and death, he says.

Phillips says the CMS appears willing to consider expanding coverage. “My sense is CMS fundamentally agrees [with the coalition’s viewpoint]. There’s nothing different about how an A Fib patient metabolizes the drug.” Heart valve and many atrial fibrillation patients should be on the drug, and both need to be managed. “The indication for use is the same for everybody,” Phillips says. “If warfarin is prescribed to the patient, then the patient should be managed into the therapeutic range, regardless of why they were put on warfarin.”

As the PST Coalition works to expand the types of conditions the CMS will cover for PT/INR home monitoring, it is also arguing against a recent recalculation of reimbursement rates that would lower federal compensation significantly.

In 2006, physicians or independent diagnostic testing facilities that provide home-monitoring devices to heart valve patients received approximately $252 for teaching patients how to use the devices, $151 per four tests for providing home-monitoring services, and an additional $9.47 per four tests for interpreting the results (National Medicare Physician Fee Schedule rates without geographic adjustment).

In proposing to slash rates this year to $220 for demonstration and training and about $135 per four tests, the CMS is beginning to phase in a change in methodology that could result in further rate cuts in the years to come, Dr. Radensky says. “2007 reflects essentially 25 percent of that adjustment being made,” he says. “If they continue along this pathway, the [rates] will drop fairly substantially.”

The CMS’ arguments contain flaws that the coalition addressed several years ago as part of the initial reimbursement agreement, Phillips says. “They were trying to say, ‘OK, how often do you do the testing? Every week. How long does the test take? Two minutes. OK, we’re going to reimburse you as if you were only using it 10 minutes per month, not all month long.’

“But we pointed out during those initial discussions back in 2000 that even though the patient would only test weekly, the monitor can’t be used by other patients. It will be in the home [and] tied to that patient for the full 30 days.” The CMS understood.

But its initial proposal for 2007 slashed rates, and the coalition reacted, Phillips says. “We went back to them, appealed it, pointing out, ‘Things haven’t changed since 2000. The patient’s still going to use this monitor X times a month. It’s dedicated to them. It’s not going to be used by another patient.’ ”

The coalition reminded the CMS that it had made a special accommodation previously and suggested it continue to do so. “The thought would be that we would be able to limit any reduction in the payment rates for these codes under the physician fee schedule,” Dr. Radensky says.

Ideally, the coalition wanted rates to remain where they have been because most practices have been reluctant to work through Medicare as it is, Phillips says. “Even with the $150.45, there’s pushback from the practices,” he says.

Cohen says the reduced payment rates will pressure suppliers of the devices to provide the products less expensively—not something he or his colleagues at other companies “have a big desire to do. We’re not sure how that’s all going to shake out yet.”

The CMS could make things easier for everyone by reimbursing for PT/INR home monitoring as durable medical equipment, rather than as a service, Cohen says. “IDTFs buy equipment from the manufacturer; then they provide it to the patient who had the prescription at no charge for the device per se,” Cohen says. The facilities then invoice Medicare monthly for the number of tests they provide. “It’s not your traditional model, like diabetes and glucose, where patients go to a drugstore and buy a meter” and the insurance company or Medicare reimburses the patient in a lump sum. “This is a little more convoluted,” he says.

That method caused what Dr. Radensky calls “hiccups” in the early going because contractors who administer Medicare locally questioned the coding. “It was unusual to have this kind of item treated as a service,” he says. The technical issues had to be worked out with the CMS and local contractors. “Most of those have been worked through at this point,” Dr. Radensky says.

Cohen remains optimistic that the CMS will see the logic of keeping rates stable and expanding the conditions for which it covers PT/INR home monitoring. “There’s definitely a need here,” he says. “The patient will benefit from this. Ultimately that will win out.” The coalition plans to reach out to other groups—the American Heart Association and American College of Cardiology, for example—for their support when it goes back to the CMS. “Over the years, the same group of people that are the advocates for this, both from the professional side and the manufacturer’s side, we’re not going away,” Cohen says.

Ed Finkel is a writer in Evanston, Ill.

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