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Originally Published IVDT May 2007 TRENDS & PERSPECTIVES
IVD reimbursement bill reintroduced in Congress
A bill designed to reform Medicare reimbursement policies for IVDs has been reintroduced in the U.S. House of Representatives. Even though it was first introduced last year (see Industry News, July/August 2006, p. 14), the Medicare Advanced Laboratory Diagnostics Act of 2007 (HR 1321) had to be reintroduced after the new Congress was elected last November. Rep. Bobby Rush (D–IL), Rep. Phil English (R–PA), Rep. Michael Ferguson (R–NJ), and Rep. Mike Thompson (D–IL) have again cosponsored the legislation.
With the exact same proposals as last year’s bill, the legislation includes four main provisions: creating a new private–public process for evaluating the accuracy of payment rates for individual tests, defining more explicitly the current process by the Centers for Medicare and Medicaid Services (CMS; Baltimore) for gathering public input on payment rates for new laboratory tests, requiring CMS to develop a new gap-fill process, and establishing a demonstration project to evaluate a new Medicare payment system for molecular diagnostic tests.
The bill has been referred to the House Committee on Energy and Commerce’s Subcommittee on Health. Once the legislation gets through this committee, it will then be referred to the Committee on Ways and Means.
According to congressional aides, Representative Rush, the bill’s lead sponsor, is planning to push aggressively for hearings on the legislation this year. The long-term plan is to advance the bill through the committees and have it put to a vote on the House floor by November 2008. While other congressmen have raised some initial concerns about costs, congressional aides are optimistic about the bill’s prospect for passage.
Industry analysts believe that not all stakeholders involved in developing IVDs may support this bill.
“Large laboratories developing their own tests, outside of FDA’s quality system regulation, are less enthusiastic because their development costs and profit margins are likely to receive closer scrutiny,” says Glen Freiberg, president of RCQ Consulting (San Diego). “This raises the question of how accuracy for payment rates could be measured and if price controls rather than simply accurate payments are behind the bill. There may be a tense divergence in support between the IVD manufacturers and the laboratories.”
Copyright ©2007 IVD Technology
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