College of American Pathologists
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  Room to grow—warfarin self-testing still lags


CAP Today




August 2010
Feature Story

Ed Finkel

The population of warfarin patients who have switched to at-home blood testing of prothrombin time/International Normalized Ratio has grown significantly since the Centers for Medicare and Medicaid Services in 2008 expanded coverage of the conditions for which it will reimburse, though estimates vary of how much growth there’s been.

But medical device makers and those who prescribe home monitoring say lack of awareness, some physician and patient resistance, and the mechanics of reimbursement have kept the market from reaching its full potential since the CMS announced it would expand reimbursement from mechanical heart valve patients to those with chronic atrial fibrillation or venous thromboembolism.

“There’s much more being done in the last two years,” says Jack Ansell, MD, chairman of medicine at Lenox Hill Hospital in New York City. “The industry is more aggressive in marketing it, and there are indications patients are receptive.”

Dr. Ansell has heard figures of between 20,000 and 30,000 patients who are self-testing, which he notes is only about one percent of the anticoagulation warfarin patient count nationwide. “It’s still very, very small,” he says, though before the 2008 CMS announcement the numbers were probably at one-tenth of their current level.

The larger numbers today pale in comparison to the 4.2 million chronic warfarin patients estimated by David Phillips, vice president of market development for Alere Home Monitoring, formerly Inverness, which has acquired once-prominent brands like HemoSense, QAS, and Tapestry during the past couple of years.

But Phillips, who reports estimates closer to 60,000 patients doing weekly self-testing, believes greater growth is still to come, given that CMS’ ruling expanded the potential market from about 15 percent of Medicare-eligible warfarin patients with mechanical heart valves to between 75 percent and 85 percent when atrial fibrillation and VTE were added to the coverage.

The biggest spike in the overall market, of about 20 percent, came in 2008, with growth of 12 percent in 2009, according to Bobby Sharp, group marketing manager for segment marketing, Roche Diagnostics. “We’re anticipating double-digit growth in the next few years,” Sharp says.

The anticoagulation management service at Massachusetts General Hospital in Boston has about 200 patients who are self-testing, out of more than 4,200 overall, and that number grows every week, says Lynn Oertel, clinical nurse specialist.

“The number of patients who can self-test has dramatically increased,” she says. “It was very limited with the former regs that dealt with the heart valve population only.... More than 50 percent of our patient clinic population has [atrial fibrillation].”

The CMS approved home testing for heart valve patients in 2002 based on literature that primarily originated in Germany and focused on that population. A meta-analysis out of Oxford University, and published in The Lancet in 2006 (Heneghan C, et al. Lancet. 2006;367:404–411), tallied the results of 14 small studies—none definitive in and of itself, but together more statistically significant, along with other recent trials. It led the agency to conclude that home testing could work for atrial fibrillation and VTE patients, Phillips says.

The remaining 15 percent to 25 percent of Medicare patients on warfarin have conditions that are not sufficiently common to be well represented in the literature, but which Phillips and others in the industry argue should be covered anyway.

“Our position was that nothing about the underlying conditions would make [the worthiness of home testing] any different,” he says. “Physicians don’t manage these patients any differently. Warfarin is a therapeutic drug. The doctor is managing the drug, not the underlying condition. But they didn’t buy it.”

Alere Home Monitoring and other companies, while focused on that argument, are also actively working to make patients and physicians more aware of self-testing and addressing doubts they have about its likelihood of success without complications, Phillips says. He understands the reluctance of patients and physicians up to a point but says the lifestyle benefit is often worthwhile.

“I’ve spoken with people who were reluctant to take vacations because they were on this drug,” he says. “But once they begin self-testing, they get self-confident and they say, ‘You know, I can leave town.’ It’s nice to see that these folks feel like they’ve got a new lease on life.”

Massachusetts General’s Oertel says “youthful retirees” who like to travel are among those most interested in self-testing. “This opportunity to take along their own self-testing device and report in their own values allows independence,” she says.

Other patients who seem most drawn to self-testing are those who still work demanding jobs, live a great distance from their physician, or don’t drive, Oertel says.

Still others have no interest, “in any way, shape, or form,” she adds. “It’s a personal choice for patients. There’s hundreds more patients who could do this easily.”

Some patients are simply better candidates than others, Phillips acknowledges, and physicians should continue to triage. Out of 100 patients, 80 might have a condition that’s covered by Medicare, and of those, 35 or 40 might be ready, willing, and able to self-test.

CMS reimbursement has encouraged new competitors to get into the device-making market, says Gerri Schultz, president and COO of Alere.

“It’s been an interesting space, that’s for sure,” she says. “Everybody and their brother is trying to get into it. Definitely, the market has opened up in a very big way with the expanded coverage.... Obviously, everything comes with reimbursement—greater awareness, more cardiologists aware, more clinics aware. I’m a big believer that this is ultimately going to be driven by the end user, the consumer.”

Phillips says acceptance is reaching an inflection point and the market will pick up momentum. “You may have two to five percent that are early adopters,” he says. “We’re coming out of that point. There’s more data and information in the literature now that the physicians who have adopted point-of-care testing and have been using it in their practice for a number of years are comfortable that the technology works. They see how easy it is. They’ve produced accurate and reliable results.”

“Ultimately,” Schultz says, “once we get the word out, we’re going to see this explode, assuming that reimbursement continues to be attached. We’re always watching that, with what CMS is going to do with health care reform.”

ITC has seen a significant increase in sales of patient self-testing devices in the past two years, largely due to the CMS’ actions, says Paul Savuto, director of market development and alternate site. In his experience, larger clinics, particularly doctors’ clinics associated with hospitals as opposed to stand-alone anticoagulation clinics, have been more likely to prescribe home testing.

Roche has found new customers in a variety of settings, ranging from primary care physicians who have one or two patients who want to self-test, to coagulation clinics that are bursting at the seams “and are finding it easier to prescribe self-testing with more-compliant patients, and to bring in patients who need more consistent monitoring at the clinic,” Sharp says. “They’re doing triage.”

Expanded coverage has helped significantly in addressing one objection physicians sometimes had—that they did not have enough patients eligible for home-testing to make it worth pursuing.

“Early on when we spoke with physicians about self-testing,” Phillips says, “if they had 100 warfarin patients, 10 of them might have a mechanical heart valve. The doctor would say, ‘It really isn’t worth my time to set up another management modality for 10 patients, some of whom wouldn’t be self-testing candidates,’ even though they might want to do self-testing.

“Now it’s, ‘Okay, most of my patients are going to fall into one of these categories. I have enough patients to make it worthwhile to invest.’ Having said that,” Phillips adds, “it’s still a fairly slow adoption.”

Physicians often start with a couple of patients who are obvious candidates, then a few months later start expanding their circle once they see how it works and fits into the practice, Phillips says.

He figures that collectively, physicians are, philosophically, about where they were with self-testing of blood glucose among diabetes patients roughly 30 years ago.

“Now, self-glucose monitoring is ubiquitous—there’s not a doctor that won’t prescribe self-blood glucose monitoring,” he says. But since home-testing of warfarin is so much newer, “Physicians are still somewhat unsure: ‘Can patients really do this? Are they going to do it correctly?’”

Dr. Ansell agrees: “Physicians are not fully aware of the possibility. And even when they are aware, they are still somewhat mistrustful or suspicious of the results.”

“It’s mostly about the control,” Savuto says. “Coumadin’s a black-box warning drug. There’s a fear-of-liability issue. Will the patient be compliant when they run the test? Are they capable of interpreting the data properly and making the right decision as far as calling the doctor, or not, if that value is out of range?”

Phillips speculates that physicians’ financial incentives may come into play, since they might be able to bill for an office visit when patients come in for a finger-stick INR. “That could influence whether the doctor prescribes it. There are a lot of dynamics here,” he says.

Savuto, for one, doesn’t think loss of income figures in. “There’s not a lot of income from [testing],” he says. “It’s because the patients are on a drug they consider to be dangerous.”

The other hurdle to climb is the three-way relationship between the patient, the physician, and the independent diagnostic testing facility (IDTF), which under the CMS reimbursement mechanism purchases the products from manufacturers and provides them to patients for as long as necessary, Phillips says.

“The patient never owns the instrument,” he says. “As long as the patient is on the drug, they have use of it. The IDTF gets reimbursed for the equipment by CMS over time. The physician gets some reimbursement for the review and interpretation of the results.”

Dr. Ansell believes the triangulated reimbursement mechanism for the devices has helped to stymie the growth of home testing. “You don’t buy the meters,” he says. “It’s more complex for the physician.”

Oertel sees a potential gap in CMS reimbursement when readings are out of range but patients are limited to one test per week.

“Let’s say you have a patient who is dutifully self-testing every week, but what do you do on week three, when the INR is elevated?” she says. “You want the patient to re-test in two days before you give further instructions. Now they potentially could be using five strips [in a month], and that patient can’t get reimbursed from CMS, when it’s clinically indicated for their safety. That’s a deficiency with the way the billing-provider reimbursement structure is set up right now.”

The IDTF is allowed to bill the CMS for every four INR readings and send results to physicians as requested, Phillips says. “Some physicians may want to know every value. Other physicians may only want to be informed when a value is out of the prescribed therapeutic range. The literature says the self-testers should be in range 70 to 90 percent of the time.”

When patients fall out of compliance, it’s the IDTF that notifies the physician, and in certain circumstances, the IDTF may reclaim the equipment, Phillips says. “The physician notifies the patient and basically says, ‘If you’re not going to follow the directions on self-testing, we need to find an alternative management strategy,’” he says. “The doctor has to find a way to keep the patient from being at risk. Ideally, it becomes a partnership between the patient, the practice, and the service provider. With everyone on the same page, it works well.”

Part of convincing doctors that home-testing can work well involves partnering with the right IDTF, Savuto says. “We’re partnered with two that do a very good job of transmitting the information from patient to physician on a regular basis,” he says. In such situations, “I think physicians would be more apt to prescribe a patient a self-testing device for home use.”

Ed Finkel is a writer in Evanston, Ill.