A bill requiring the Department of Health and Human Services to publish recommendations for the development of clinical data registries was approved in a July 30 vote by the House Energy and Commerce Committee, but not without 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, Rep. Frank Pallone, Jr. (D-N.J.), the top Democrat on the subcommittee on health, objected to the fact that a hearing was not held on the bill and it did not go through regular order in the subcommittee. More importantly, bill sponsors havent done their homework and the bill isnt needed, he contends.
This bill wasnt 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 its bipartisan. I dont think its 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 cant support a bill that adds more bureaucracy and duplicates whats already out there.
According to Pallone, 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 donamely, to provide detailed information on how to establish, operate, and use registries for quality and outcomes improvement.
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 isnt that provider organizations dont know how to set up a registry. The real problem is a lack of funding, Pallone said. Thats 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.
AMAs NQRN is a voluntary network of organizations operating clinical registries and working to increase the usefulness of registries to measure and improve patient health outcomes. An AMA spokesperson told Health Data Management that it has concerns about the bill but would not elaborate.
Nonetheless, R. Mack Harrell, M.D., president of the American Association of Clinical Endocrinologists (AACE), said his organization is supportive of the bill, specifically the provision calling on HHS to recommend a set of standards that would allow for the bidirectional, interoperable exchange of information between the electronic health records of reporting clinicians and clinical data registries.
We havent had the bidirectional flow of information and we still have very burdensome regulatory requirements in a lot of areas that have not been improved by EHRs, said Harrell. Theres so much power in the information if were able to use it properly. It would be a shame to miss out on the advantages of all this information collection. But doctors are upset because largely the information is just being used administratively for billing, not to improve care. And, thats where we think the registry piece can make a big difference.
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.
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