Clinical Data Registries Bill Advances Despite Opposition
By Christine Kern, contributing writer
If passed, the legislation would direct HHS to create guidelines for clinical registries.
A bill requiring the Department of Health and Human Services to publish recommendations for the development of clinical data registries was approved in a vote by the House Energy and Commerce Committee, accompanied by sharp opposition from Democratic members.
In a markup of H.R. 5214, the House committee voted 25 to 18 to report the bill to the House floor. However the top Democrat on the subcommittee on health, Rep. Frank Pallone, Jr. (D-NJ), objected because there was not a hearing on the bill and it did follow regular order in the subcommittee. Furthermore, he contended, bill sponsors haven’t done their homework and the bill is unnecessary.
“This bill wasn’t even introduced until Monday night and there has not been a real opportunity to review this bill,” said Pallone. “I know the chairman of the subcommittee says that it’s bipartisan. I don’t think it’s bipartisan … this thing could be bipartisan if the Republicans were willing to cooperate with us.
“We all agree that registries are a good thing. In fact, they were a big part of the discussion during the SGR process (Medicare physician payment debate last spring) and we remain committed to our efforts to enact those registry provisions,” he added. “But, this new bill appears to duplicate current public-private efforts that are already in existence … I can’t support a bill that adds more bureaucracy and duplicates what’s already out there.”
Pallone indicated that both the American Medical Association – through the National Quality Registry Network (NQRN) – and the Agency for Healthcare Research and Quality, through its extensive public-private registry user guide, “have already done exactly what this bill appears to be seeking to do” – namely, to provide detailed information on how to establish, operate, and use registries for quality and outcomes improvement.
According to HealthData Management, the proposed legislation directs HHS to come up with recommendations on how clinical registries, including outcomes-based registries, may be developed and used to evaluate the impact of care models and methods on the management of chronic diseases based on clinical practice guidelines and best practices.
“The problem isn’t that provider organizations don’t know how to set up a registry. The real problem is a lack of funding,” Pallone said. “That’s why the bipartisan SGR bill included provisions that would incentivize the development and use of registries … the knowledge on registries is out there and groups just need the funding to execute it.”
The bill directs HHS to consult with national medical specialty societies, such as AACE, with respect to diabetes and pre-diabetes conditions, in the development of recommendations on how data from registries may be used to inform physicians and other healthcare professionals regarding clinical practices for the prevention of chronic diseases.