Draft legislation in the House Energy and Commerce Committee would require the Department of Health and Human Services to publish recommendations for development of clinical data registries to improve patient care.
The bill, introduced by Rep. Pete Olson (R-Tex.), calls for specific recommendations from the HHS Secretary for a set of standards that, if adopted, would allow for the bidirectional, interoperable exchange of information between the electronic health records of the reporting clinicians and such registries. 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--such as A1C, blood pressure, and cholesterol levels in the case of diabetes.
Data registries hold great promise for the future of healthcare in this country. However, expertise in their construction and operation varies significantly, said Committee Chair Fred Upton (R-Mich.). This legislation would encourage the development and dissemination of best practices designed to support registry development that works for patients, provider groups and other stakeholders.
How clinical registries can be used to reduce the risk of chronic diseases, such as diabetes, cardiovascular disease, and cancer, is of particular interest, according to the bill. Ostensibly, HHS would recommend how data from such registries may be used to inform physicians and other healthcare professionals regarding clinical practices for the prevention of diseases, as well as the appropriate methods for the dissemination of clinical practice support tools and other educational resources that may be derived from registry data.
In making its recommendations, the bill asks that the HHS Secretary consult with national medical specialty societies, such as the American Association of Clinical Endocrinologists with respect to recommendations relating to diabetes and pre-diabetes conditions.
However, Rep. Henry Waxman (D-Calif.), ranking member of the committee, noted that the American Medical Association opposes the bill because they think its over-burdensome and may have the opposite effect, making it more difficult to create the registries. Waxman said he wants to explore AMA opposition in a congressional hearing.
An AMA spokesperson told Health Data Management: We have concerns about the bill and hope to discuss them with the committee.
On Monday, the committee scheduled a legislative markup to consider the clinical data registries bill. But, Rep. Frank Pallone, Jr. (D-N.J.), the top Democrat on the subcommittee on health, raised an objection because a hearing was not held on the bill and it did not go through regular order nor comply with House rules requiring advance notice.
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