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Shortchanged: Dollars don’t add up for prothrombin home monitoring


Prothrombin self-testing: where the lab comes in



August 2002
Karen Southwick

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 effective."

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 vendors.

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 service."

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 consultant.

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," Phillips says.

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 seen."

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," he says.

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 business."

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 the cost.

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 the CMS.

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 changes."

"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 limits.

"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.