• Legal barriers to implementation: needed changes to copyright and antitrust laws that protect IT
  companies

Bush Administration Actions:  The Bush Administration has made a big push to elevate the issue of EHRs.  However, most of the action so far has been preliminary:  setting up commissions and scheduling meetings, appointing a policy coordinator for the issue, and forming "wish lists" of policy recommendations and goals.  One of the more successful measures by the Bush administration was accomplished with the signing of the Medicare Modernization Act in 2003.  Though MMA's IT provisions mostly involve e-prescribing, the bill requires the establishment of a Commission on Systemic Interoperability to evaluate costs and benefits of setting interoperability standards and to determine industry requirements for implementing such standards.  The commission is expected to submit its report to Congress and the Secretary of the Department of Health and Human Services by October of 2005.

In June 2004, President Bush received a report from the President's Information Technology Advisory Committee (PITAC) outlining its recommendations for the implementation of healthcare IT.  Among the committee's recommendations were: 1) increased federal support for community and regional demonstrations of EHR systems that promote data exchange, 2) coordination of various federal agencies (Department of Defense, Food and Drug Administration (FDA), Health and Human Services (HHS),Veterans' Administration (VA), etc.) to monitor these demonstrations and develop standards for gathering and storing information to streamline the process of data sharing, 3) establish a task force to identify actual and perceived legal impediments to the sharing of EHR technology, and 4) standardize clinical vocabulary to facilitate interoperability of systems.

On July 21st, Secretary of Health and Human Services Tommy Thompson and Dr. David Brailer, President Bush's recently appointed policy coordinator for health information technology, announced the "Decade of Health Information Technology."  This report included a list of initiatives including use of low-rate loans as incentives to adopt EHRs, Medicare reimbursements under the physician fee schedule for the use of EHRs, a pay-for-performance system to reward physician EHR implementation, a revision of physician self-referral and anti-kickback protections, and regional grants and contracts.

Most recently, GAO’s August 13th report says that despite HHS’ efforts to implement new technologies, it has done little to deal with laws that may inhibit adoption.  The incentive offered in the “Decade” agenda that came under fire in the report was the alteration of physician self-referral and anti-kickback rules.  According to the GAO, the interim rule established in March that says self-referral would not apply to “communitywide health information systems” is not straightforward enough to guard against lawsuits.  Additionally, there have been no changes made to antitrust laws to accommodate the widespread arrangements that IT companies will make with providers nor have there been any revisions to copyright laws to protect IT companies that invest in EHR system and software designs. 

One of the long-running complaints of policymakers and proponents of health care technology is the lack of a decisive and forward-moving leader in the federal government.  The greatest service that HHS has provided thus far has been stepping up with clear and (hopefully) workable steps toward solving the problems of implementing EHR technology.  HHS has planned five regional and state demonstrations of EHR technology for FY 2004, and funding for FY 2005 has been doubled to $100 million by President Bush.

The elections probably wouldn't affect this momentum toward EHRs.  Senator Kerry has similar plans for health technology and quality if he is elected in November.  Kerry’s healthcare plan reveals that the Senator would offer grants for healthcare providers to help with start up costs and he would require health plans that are part of federal programs to update their systems and incorporate information technology.  Kerry has set his deadline for “secure, private electronic medical records” for 2008.

Congressional Bills:  Senators Hillary Clinton, Judd Gregg, and Edward Kennedy, and Representatives Nancy Johnson and Patrick Kennedy have all introduced their own legislation intended to foster the adoption of EHRs.

According to an article in iHealthbeat, Senator Clinton’s bill (S.2003) includes Congressional funding for research in this area. Additionally, the Senator proposes a standardized online reporting system that would help patients in choosing their hospitals.  The bill calls for government funds to assist hospitals in upgrading and implementing new computer systems.  Clinton’s approach is the most comprehensive of these bills since it also establishes requirements for voluntary interoperability standards and incorporates some of the newer technologies (handheld databases and in-home Internet access) to facilitate communication between doctors and their patients.  Though this bill focuses on hospitals and their use of EHRs, it is progressive in its inclusion of informed patients in their own healthcare decision-making.

Republican Senator Judd Gregg introduced a bill (S. 2710) on July 21 of this year that would fast track the proposals made by HHS and Dr. Brailer.  Senator Gregg suggests the creation of an Office of Health Information Technology within the Office of the Secretary of Health and Human Services, the head of which would, within 2 years, adopt standards of practice and terminology that would be mandatory for public sector health providers.  These standards would be voluntary for private providers. The bill would also provide funds for Local Health Information Infrastructures (LHIIs), local communities that use federal interoperable systems that are electronically linked to share data.  This bill is a good example of conservative leadership on this issue.

Senator Edward Kennedy’s bill (S.2421) requires healthcare providers to move to EHRs and electronic claims by 2011.  The bill stipulates that qualifying systems must meet standards of interoperability, security, and confidentiality.  Sen. Kennedy’s bill contains other baggage: requiring schools that receive federal funding to ban soft drink sales; preventative health care measures involving immunization and oral care, and requiring group health plans to cover preventative care; and the establishment of a National Quality Advisory Council.  Kennedy’s bill won’t get far with the extra-technological provisions it contains and he probably knew that when he introduced it.  Clinton’s bill is more focused and more practical than her Democratic colleague’s and it shows that she is thinking about the strategies for getting the job done. 

In the House, Representative Nancy Johnson launched her own legislation (H.R. 2915) in 2003 which, provides for a National Health Information Officer (much like the current position held by Dr. Brailer). Johnson’s bill deals more with setting standards and provisions for the monitoring of the technology and less with creating incentives or mandates for implementation of EHRs.

On July 21 of this year, Congressman Patrick Kennedy introduced a bill known as "The Josie King Act," named for an 18 month-old infant whose death was the result of medical errors.  Rep. Kennedy's bill calls for interoperable regional networks that are funded through public-private partnerships.  It also offers new incentives such as scholarships for healthcare leaders who want the skills to work with these types of IT systems, and "pay for performance" initiatives for publicly funded measures.  Congressman Kennedy's bill emphasizes that IT can be used as a quality tool, especially in cases like Josie King's.  This effort seems to be the most promising.

These Congressional bills have several key similarities and most seem to address, at least in part, the barriers to EHR implementation.  However, there are important ideological differences as well.  For example, Democrats tend to be concerned with issues of privacy and security while Republicans tend to focus on preventing overregulation of an industry that is heavily driven by innovation and free market exploration.  Neither side seems afraid to spend money on the issue, whether through loans or grants, but the Republican side has more of an interest in piloting community-based programs while the Democrats insist on system-wide change.  Both sides have valid viewpoints and both are keeping the discussion balanced.  The problem is, the technology threatens to outpace the discussion if the legislature doesn't take decisive action soon.  As with the Bush Administration, Congress is trying to decide where to start. 

Clearly, both sides would like to see some form of federal office established at HHS to handle the burgeoning dilemmas of integrating IT.  Most of the Congressional plans also include some provision for the creation of standards within the healthcare industry that would support a transition to electronic-based record keeping. 

Perhaps the best hope for any of these initiatives is that there is a consensus that something needs to be done.  In order for EHRs to succeed, those who have the highest stakes in their implementation: providers and practitioners, patients, and payers, must all be considered in the discussion.  One of the potential problems that arises when the government addresses issues of technology is that the technology often outpaces legislation.  Involving the IT community in policymaking and planning is essential. The easiest place to start implementation would be in existing health plans (Medicare, private health plans) and larger institutions like hospitals since both have data that could be readily converted to EHRs.

Links:
Web accessible text of August 13, 2004 GAO report entitled "'HHS's Efforts to Promote Health Information Technology and Legal Barriers to Its Adoption"

President's Information Technology Advisory Committee (PITAC) Report, "Revolutionizing Health Care Through Information Technology" (June 2004)

Department of Health and Human Services Report "Decade of Health Information Technology: Framework for Strategic Action"  (July 21, 2004)

John Kerry 2004 Campaign: Healthcare Plan

Centrists.Org Senator Kerry's Health Proposal -- Prospects for Bipartisanship? (August 25, 2004)

iHealthBeat's article on Senator Clinton's IT bill (January 13, 2004)

Full text of bills discussed in this article:
        Senator Hillary Clinton S.2003
        Senator Judd Gregg  S.2710 
        Senator Edward Kennedy S.2421
        Representative Nancy Johnson H.R.2915
        Representative Patrick Kennedy H.R. 4880