President Obama has signed the health reform package (PDF). Love it or hate it, the health reform passed by the Senate and the House has now become law. The Senate will grapple with the fixes proposed by the House and we may end up with some changes, but the existing law will have a wide-ranging impact on the health IT industry. I am slogging my way through reading the bill and thought I would point out highlights I’ve found so far.
There are sections on Quality Reporting, Administrative Simplification, creation of a National Medical Device Registry, a new Center for Comparative Effectiveness Research, and the creation of the Assistant Secretary for Health Information. I’m sure there is still a great deal more that I will uncover over the coming weeks, but some of the pertinent sections of the bill are:
Under the section, Part D – Implementation of best practices in the delivery of healthcare, the health reform package establishes within HHS an Assistant Secretary for Health Information. This will certainly raise the level of the conversation surrounding health IT. The Assistant Secretary will work “in consultation with the Director of the Office of Minority Health, and the Director of the Office of Civil Rights, of the Department, develop standards for the collection of data on health and health care with respect to primary language.” The Assistant Secretary will also coordinate with the head of the Office of the National Coordinator for Health Information Technology to ensure optimal use of health information technology. So this position will certainly augment the work of the ONC.
I think the creation of a National Medical Device Registry will have a profound impact on health IT. The registry would list devices by type, model and serial number or other unique identifier. It is intended to help HHS assess the post-market safety and effectiveness of all class III devices, and all class II devices that are implantable, life-supporting or life-sustaining, according to the bill. The registry, to be established by HHS, would link data provided by manufacturers to the FDA, with outcomes data from multiple sources. The bill also authorizes HHS to require device makers to submit “such other information as is necessary to facilitate post-market assessments of device safety and effectiveness and notification of device risks.”
The section under subtitle A – Comparative Effectiveness Research, states that “the Secretary shall establish within the Agency for Healthcare Research and Quality a Center for Comparative Effectiveness Research” and that “the Center may secure directly from any department or agency of the United States information necessary.” This new Center for CER will be encouraging “the development and use of clinical registries and the development of clinical effectiveness research data networks from electronic health records, post marketing drug and medical device surveillance efforts, and other forms of electronic health data.”
There is significant language dealing with administrative simplification as Health Data Management reports:
The bill requires HHS to seek public input and consider whether to standardize the application form for insurance enrollment, as well as worker’s compensation transactions, and automobile insurance-related health care transactions … Further, HHS is mandated to consider “whether there could be greater transparency and consistency of methodologies and processes used to establish claim edits used by health plans,” and whether plans should be required to publish their timeliness of payment rules.
There is also a section referring to health IT regarding enrollment standards and protocols: “Not later than 180 days after the date of enactment of this title, the Secretary, in consultation with the HIT Policy Committee and the HIT Standards Committee, shall develop interoperable and secure standards and protocols that facilitate enrollment of individuals in Federal and State health and human services programs.”
The section under subtitle E – Public Reporting on Health Care-Associated Infections, is also very interesting. Aside from the technology involved in collecting data, the requirement that “information shall be set forth in a manner that allows for the comparison of information on health care-associated infections” provides some interesting possibilities for mashups with existing data sources.