Birth of Change in Medicare Benefits: The Story of tPA

Photo by Graham Ramsay Erica Seiguer

The new Medicare prescription drug benefit plan, which took effect this month for enrollees, is not the only recent, long-awaited change in Medicare reimbursement. In the decade since it was approved by the Food and Drug Administration, tissue plasminogen activator (tPA), a reperfusion therapy for cardiac and stroke care, has revolutionized treatment of -ischemic stroke, one of the leading causes of death in the United States. Studies now show that tPA leads to clinical improvement through early, sustained recanalization of a blocked cerebral blood vessel. This advance results in an overall drop in Medicare’s cost for strokes due to a decreased need for rehabilitation and long-term care.

Despite the nation’s estimated $57 billion in yearly direct and indirect costs due to strokes, it was only last October that the Center for Medicare and Medicaid Services (CMS) decided to reimburse hospitals for the additional expense of reperfusion therapy for acute patients. If given within three hours after the onset of a stroke, tPA can increase the proportion of patients with good outcomes and limit their disability. Endovascular clot dissolution or removal has also been utilized in specialized centers over the last decade to achieve brain reperfusion, and the FDA recently approved a clot retrieval device for stroke treatment.

Prior to the October coverage decision, Medicare paid hospitals a set amount per patient treated for stroke, whether reperfusion therapy was used or not. The Academy of Neurology, the American Stroke Association, and other members of the Brain Attack Coalition (BAC)—a group of professional, voluntary, and governmental entities working to improve stroke care—argued that patients who receive reperfusion therapy require more hospital resources than patients who do not. Increased intensity of patient monitoring; laboratory, pharmacy, and neuroimaging costs; and hospital infrastructure costs have all been cited as barriers to the appropriate use of clot-busting drugs and devices.

The standard stroke payment code, DRG 14, gave hospitals only about $5,600 per stroke patient. The additional cost of tPA is about $2,000 per administration, and the cost of infrastructure associated with establishing a system for administering it safely have been another financial disincentive for hospitals, according to Walter Koroshetz, director of Massachusetts General Hospital Stroke and Neurointensive Care Services and an HMS professor of neurology, who has been active in efforts to improve stroke care. Medicare’s decision to pay about $6,000 in addition to the base reimbursement for cases of stroke treated with acute reperfusion therapy was hailed by many as a major advance in the treatment of a condition that affects about 700,000 Americans each year and leaves 15 to 30 percent with permanent disabilities. The new Medicare rule, which took effect on Oct. 1, created a new DRG for acute ischemic strokes for which reperfusion therapy is used and will reimburse hospitals $11,578 for the care.

Koroshetz was involved in convincing CMS to develop the new DRG through his work as chairman of the task force on reimbursement at the BAC. Beginning in 2002, the BAC began meeting with CMS officials and, in 2003, Koroshetz, along with Larry Brass from Yale and Ellen Magnis from the American Stroke Association, presented to CMS data from Clay Johnston, director of the UCSF stroke service and an expert on stroke epidemiology. The data showed that patients treated with tPA were twice as expensive to care for as the average stroke patient coded under the standard stroke DRG. Other data-sets, including Medicare’s own MedPar databank, were subsequently analyzed, showing an almost identical doubling of hospital costs in tPA-treated patients. In fact, treatment with tPA is an identifier of the most costly patients.

Money Loser No More?
Kieran Murphy, director of interventional neuroradiology at Johns Hopkins, believes that the financial support of CMS will improve stroke care, which he says often imposes a financial strain on hospitals and physicians. “Neurologists lose money on acute stroke patients,” he said. “The new DRG allows an institutional commitment to the process. Then you can go to the hospital administration and make the case and justify it financially.”

For major stroke centers, such as Hopkins, tPA has been used regularly because of a “philosophical commitment, not one reimbursed financially,” according to Murphy. He expects that the impact of CMS’s decision will be felt among smaller hospitals and small groups of practicing physicians, who previously may not have been able to justify the additional expense associated with administration of tPA. “This is an example of CMS taking a great step forward and doing the right thing, and they deserve credit,” he said.

Divergent Views on tPA
Yet might the creation of the new DRG lead to overuse of tPA, which can result in catastrophic harm to a patient if given in cases of hemorrhagic strokes? Murphy does not believe that overuse is a major concern because physicians, in his view, are not yet comfortable using the drug. Koroshetz concurs, saying that the drug is too dangerous for anyone to consider administering based on reimbursement issues.

In fact, the American Academy of Emergency Medicine has yet to endorse tPA. The academy states that “objective evidence regarding the efficacy, safety, and applicability of tPA for acute ischemic stroke is insufficient to warrant its classification as standard of care.” Murphy believes resistance to its use may be related to “conservative medical culture” and the litigious nature of medical practice.

Many stroke physicians see this emergency medicine position as defensible in situations in which there is no infrastructure to ensure the safe use of tPA. One major component of such an infrastructure is the need for 24/7 stroke neurology expertise to help guide decision-making in the emergency department. Koroshetz argues that “emergency physicians should not be abandoned to make critically important, high-level neurological evaluations that stress even the most experienced stroke experts.”

He is optimistic, however, that the new DRG will improve stroke care by removing at least some of the financial barriers. “We hope that hospitals see that acute stroke patients are not making them money losers,” Koroshetz said. “We hope to take away this disincentive so they might decide to set up stroke centers. Stroke care won’t be a money maker, but hopefully it won’t be a money loser.”

—Erica Seiguer is an MD–PhD student studying economics in Harvard’s Doctoral Program in Health Policy.

Related Websites

The Brain Attack Coalition
MGH Stroke Center
The Internet Stroke Center
The Cochrane Stroke Group

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