In the decade since it was approved by the Food and Drug Administration, tissue plasminogen activator, or tPA, a reperfusion therapy for cardiac and stroke care, has revolutionized the treatment of stroke -- the third leading cause of death in the U.S., and the leading cause of adult disability.Until the mid-’90s most physicians were trained to believe that little could be done to alleviate the severe neurologic disability that occurs with a stroke. However, laboratory work in animal models of ischemic stroke and studies in patients using positron emission tomographic imaging demonstrated that the process of permanent brain injury, or cerebral infarction, occurs over a variable time course, usually measured in hours. Reports began to appear of "Lazarus-like" patient improvement with rapid removal of a clot obstructing a cerebral vessel. In patients with acute coronary syndromes, multiple trials of intravenously delivered tPA to dissolve blood clots obstructing coronary arteries were shown to decrease patients’ mortality. The National Institute of Neurological Disorders and Stroke was at the forefront of testing the efficacy and safety of tPA for stroke. A carefully designed clinical trial of acute-ischemic-stroke patients found that those treated with tPA had a statistically significant better chance of a good recovery status by three months -- a benefit that was sustained at follow-up. In 1995, the FDA approved tPA use within three hours of ischemic stroke onset. Safe tPA administration requires systems to be in place. An effective infrastructure for emergent care includes an acute-stroke team able to respond around-the-clock, a specialized unit dedicated to stroke care, appropriate laboratory services and a staff that undergoes regular continuing medical education. A major barrier to stroke care has been financial. Despite the nation’s estimated $57 billion in yearly direct and indirect costs related to stroke, it was only in October 2005 that the CMS decided to reimburse hospitals for the additional expense of reperfusion therapy for acute stroke. Prior to the 2005 coverage decision, Medicare paid hospitals a set amount per patient treated for stroke, whether reperfusion therapy was used. Members of the Brain Attack Coalition -- a group of professional, voluntary and governmental organizations working to improve stroke care -- argued that patients who receive reperfusion therapy require more hospital resources than patients who did 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 about $5,600 per stroke patient, and Medicare reimbursed hospitals $2,000 per administration of tPA to cover the costs of the drug itself. It is believed this reimbursement level, along with the cost of the infrastructure associated with establishing a system for using tPA safely, were financial disincentives for hospitals to give tPA. Brain Attack Coalition members, along with other stroke leaders, presented data to the CMS showing patients treated with tPA were twice as expensive to care for as the average stroke patient coded under the standard stroke DRG. In its 2005 ruling, the CMS recognized this disparity and instituted DRG 559 for acute stroke patients treated with a reperfusion agent. DRG 559 doubles the payment -- now approximately $11,500.
Walter Koroshetz, M.D., is vice chairman of the department of neurology at Massachusetts General Hospital, Boston, and professor of neurology at Harvard Medical School. He has served as chairman of the Reimbursement Committee of the Brain Attack Coalition for the past four years. Erica Seiguer is an M.D.-Ph.D. candidate studying economics in Harvard University’s doctoral program in health policy. Marian Emr is the director of the Office of Communications and Public Liaison at the National Institute of Neurological Disorders and Stroke, National Institutes of Health. Nancy Hart is coordinator of the Brain Attack Coalition at the National Institute of Neurological Disorders and Stroke, National Institutes of Health.