EDITOR'S PAGE

This year, Washington, DC, seems more than usually awash in a backlog of proposed legislation that could have significant implications for medical device companies.

To offer one example: the Medicare Advanced Laboratory Diagnostics Act of 2007 (HR 1321 and S 2404) was referred to the House subcommittee on health and the Senate Finance Committee in 2007, but neither committee has acted. Given the complexity of this bill, which would modernize the Medicare clinical laboratory fee schedule, any progress in 2008 would be a miracle. Look for the legislation to be reintroduced (a third time) in the 111th Congress.

Meanwhile, patent reform—long an issue of congressional interest and a key concern among medtech manufacturers—seems to have hit a wall. In early May, the Senate version of the Patent Reform Act (S 1145) was taken off the floor schedule—meaning the legislation will not be considered by the full Senate any time in the near future.

Legislative efforts designed to increase transparency into physician payments gained significant momentum early this year—only to languish in committees in recent months. The Physician Payments Sunshine Act (HR 5605 and S 2029) would require device manufacturers to report all physician payments and gifts. Given the trend toward increased scrutiny of medtech marketing practices, it is likely that such legislation will eventually become law—but the timetable for congressional action remains unknown.

With the presidential election looming, Washington officials seem destined to be distracted by campaigning and other activities for the remainder of the summer. But while Congress may be holding its breath and waiting to see who will become the next U.S. president, that doesn't mean that the rest of the world's activities have to be reduced to mere silliness. Now is a great time for medical device executives to be actively positioning their companies and their industry, so that when these issues come off the back burner, legislative decisions may be more likely to swing in their favor.

Copyright ©2008 MX