Postmarketing surveillance of medical devices using Medicare claims.
The current system of postmarketing surveillance of high-risk medical devices could be improved by taking advantage of the administrative billing data collected by the Centers for Medicare and Medicaid Services (CMS) to systematically monitor for adverse events that may signal device-related problems. In this paper we use the current concern about the excess risk associated with drug-eluting coronary stents to highlight the strengths and weaknesses of claims data for postmarketing surveillance and propose a pilot collaboration between government, industry, and academe to systematically explore the use of Medicare claims data for this purpose.
Malenka
David J
DJ
Dartmouth-Hitchcock Medical Center, in Lebanon, New Hampshire, USA. David.Malenka@Hitchcock.org
Kaplan
Aaron V
AV
Sharp
Sandra M
SM
Wennberg
John E
JE
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D014487:Centers for Medicare and Medicaid Services, U.S.; D015331:Cohort Studies; D023903:Coronary Restenosis / Q000517:prevention & control; D004337:Drug Carriers / Q000009:adverse effects*; D004864:Equipment and Supplies / Q000009:adverse effects* / Q000592:standards; D006801:Humans; D007345:Insurance Claim Review; D006278:Medicare / Q000706:statistics & numerical data*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D015607:Stents / Q000009:adverse effects*; D013927:Thrombosis / Q000139:chemically induced* / Q000453:epidemiology; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
D004337:Drug Carriers