NY Times Calls for National Joint Registry
BY LAUREN UZDIENSKI, JULY 29, 2008
Following Zimmer's announcement that the company would suspend sales of the Durom acetabular cup, the New York Times suggested this morning that the concerns about Durom could've been identified sooner if the U.S. had a national joint registry in place.
Similar registries are in place in Australia and Sweden, but there is no such system in the U.S. The scope of a U.S. registry is one challenge; the U.S. implants over one million hip and knee devices each year, roughly half of the world's total, and the countries that have registries tend to have more centralized healthcare systems. A registry is estimated to cost $5-$10 million per year, and it is unclear who would pay for it. There would also have to be protections of patient privacy and legal rights. Another concern is surgeon cooperation. The Times interviewed Dr. William Jiranek, an orthopedic surgeon who has lobbied to start a registry in Virginia, and he said that only 6 of the 200 surgeons practicing in the state have been contributing data. "Most [surgeons] are supportive," he says. "Few of them are willing to do a lot of work." The Times adds that surgeons' financial relationships with devicemakers may also provide a disincentive to contribute, though with the combination of the rise of evidence-based medicine and post-settlement tone of physician interaction with industry, that may be quickly changing.
There is also the question of who would run the registry. CMS is a likely choice, and if participation were mandatory, registry submissions could easily be linked to reimbursement. However, CMS has indicated in the past that they're not thrilled about shouldering the project. Two years ago, AAOS approached them about funding a pilot project that could evolve into a national registry. CMS passed, with CMS Chief Medical Officer Dr. Barry Straube saying that the agency did not use registries to monitor proven treatments. The Times quoted Dr. Straube, "If you pay for funding for one interest, you have to justify why you are not doing that for anyone else." Despite the opposition, the financial benefit of such a registry could be significant for the agency; there would be substantial data to identify the most effective products, and money would be saved in avoiding certain revision procedures. The underfunded FDA already monitors a huge number of products without the demands of overseeing a registry, and they also lack the financial incentives to report data that CMS can offer. The FDA does offer product performance surveillance tools, including the MAUDE and MDR databases, though those are limited to single reports of adverse events, and the Times says that few physicians submit to the database.
The purpose of a registry isn't all adverse event reporting. The data is used by companies in product marketing (Smith & Nephew frequently touts the Australian registry data in support of their BHR system.) The volume of data helps good technology stand out, and the registry can provide an opportunity for companies to distinguish their products and demonstrate outcomes, effectively creating a multi-center, national collection of data that comes at little cost to the company.
Whatever the potential gains, finding a home (and funding) for the registry is likely to remain a major hurdle. The country's "sprawling and fragmented" healthcare system may not be ready to organize a registry, but increasing demands for strong evidence and cost-effectiveness could help mobilize physicians and industry in support of the project, a first step in its realization.
