Lawmakers will likely wait to see what the long-anticipated healthcare-reform legislation package will include before moving on several high-profile bills that, if passed, would significantly affect how medical-device and drug companies develop, market and manufacture their products, healthcare policy experts say.
Waiting for reform
Device bills indicate excitement for legislation
Hundreds of healthcare-related bills, at least eight of which would affect the medical-products industry, have seen little movement since their introduction to the Senate or House earlier this year. But legislation hawks say that doesnt mean several high-priority bills are stuck and in danger of not being brought to a vote sometime in 2009. If theres any increase in the number of bills in waiting, its because people are really excited about healthcare and people want to get their bills in to be considered as part of healthcare reform, said Ashley Glacel, spokeswoman for the Senate Aging Committee, which has helped draft a number of healthcare bills, including the Physician Payment Sunshine Act and the Nursing Home Transparency and Improvement Act. I know with our staff, a lot of the feeling is if we dont get (legislation) in now, why bother? It could be too late.
Brett Loper, director of government affairs for the Advance Medical Technology Association, a medical-device lobby group, agreed that reform efforts are driving the pace of movement on a number of bills. The situation on the healthcare reform front is one that comes along once in a generation: Its like the Super Bowl of healthcare. So its logical to think that there will be one bill that affects everything. Its addressing $2.5 trillion in spending a year.
Among the high-profile bills of concern to medical-product manufacturers are the Physician Payment Sunshine Act of 2009, which would mandate public disclosure of financial relationships between medical-products companies and healthcare providers; the Medical Device Safety Act of 2009, which would reverse the recent Supreme Court precedent that bars patients from suing manufacturers over damages caused by FDA-approved products; and the Food and Drug Administration Globalization Act of 2009, which would give the FDA greater authority in governing and ensuring the safety of the medical-products supply chain.
Blair Childs, spokesman for group purchasing and healthcare quality-improvement organization Premier, echoed Glacels and Lopers observations, but added that lawmakers also are trying to take a global look at proposed healthcare legislation to see how all the parts fit together. A lot of ideas in individual bills are being woven into the broader package so they can consider if you move one dial what would it do to other knobs on the dashboard, Childs explained.
That balancing act means legislators are working to strike the right note on bills like the Sunshine Act, which, if passed, would address a growing demand to eliminate medical-product manufacturers influence on doctors treatment decisions, and help curb spending on physician-preference items. But the bill also could threaten industrys funding of medical innovation if the disclosure requirements are so stringent that they would reveal trade secrets about certain kinds of research and development projects, critics say. Such a move could ultimately place a heavier burden on government to finance research and have a negative effect on healthcare reforms cost-containment efforts.
Washington-based healthcare lawyer Susan Berson of Mintz Levin said while some of the current bills affecting the medical-products industry may be targeted for inclusion in the larger reform packagewhich both the House and Senate hope to have final drafts of by early Septemberothers are going to face wrangling over viability issues. If you look at the (FDA Globalization) bill its a very complicated issue, because you need to come up with a way to track products, she said.
The U.S. medical-products industry has yet to sign off on a universal tracking system. Recent actions and endorsements suggest that drug companies and devicemakers are moving toward standards developed by GS1, a global supply-chain management organization, but timing and certainty of that adoption are pending.
Government can mandate, but if industry isnt prepared, it will take time to determine exactly how some of this will take place, Berson said.
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