Qual-IT - September 2006 | Archived

This summer, the initial building blocks of a national HIT strategy were put in place by HHS with the publication of final rules governing donation, to providers, of HIT products for electronic prescribing and electronic health records (EHRs), and with the first set of certification criteria for EHRs.  In addition, President Bush issued an executive order requiring all federal health programs to utilize HIT products that meet interoperability standards, and requiring the use of such products in contracts with health plans and providers.  These requirements obviously have broad national implications, but they also have special significance in New York State, where organizations awarded funds through HEAL-NY grants will be expected to conform to these standards.

Medicare laws designed to curb fraud and abuse prohibit financial kickbacks and other referral arrangements among providers.  The Medicare prescription drug law, however, as well as the President's executive order to make EHRs available for all Americans by 2014, call for establishing “safe harbors”—exceptions to these stringent rules—for donations of electronic prescribing and EHR tools.  HHS has now developed regulations, announced in August, spelling out the conditions for these arrangements.

The final regulations, separately published by the HHS Office of Inspector General and the Centers for Medicare & Medicaid Services, clearly define how HIT can be legally donated to providers.  Several important issues are addressed.  First, the regulations permit the donation of software for electronic health records, or hardware and software for electronic prescribing, only if programs are interoperable, defined broadly as capable of communicating with and transmitting information across different systems, applications, and networks.  As discussed in previous issues of Qual-IT, there is a longstanding emphasis on interoperability; in this context, the “transparency” fostered by interoperability is viewed as protection against arrangements benefiting specific commercial or institutional interests. 

The regulations further define interoperability in the context of emerging national standards for HIT products, including those used for electronic prescribing and EHRs.  When the draft rules were published no such standards existed, so there was significant concern about how practical it would be to require interoperability.  There is widespread agreement, however, that such standards are necessary, because some of the many different products offered by HIT vendors are simply not designed for clinical health information exchange within and across health care systems.

The new rules for EHRs also establish a cost allocation requirement that a donor's contribution may not exceed 85 percent of the total value of donated products and services.  This cost-sharing requirement is necessary, both the HHS Inspector General's Office and the Centers for Medicare & Medicaid Services commented, to ensure that recipients have a direct financial stake in using and maintaining these systems.  On the other hand, providers who are unable to meet the 15 percent share of costs would not be able to take advantage of the safe harbor regulations, limiting physician and consumer access to the benefits of HIT.  The cost-sharing requirement does not apply to donations of HIT used solely for electronic prescribing.

To meet the new requirements, technology products and services will need to comply with standards recognized by HHS under a new product certification process.  That process stems from the recent authorization, by the Secretary of HHS, of the Certification Commission for Health Information Technology (CCHIT) to develop certification standards, including interoperability requirements, and apply them to specific HIT products.  The safe harbor rule will apply initially to products certified as meeting these standards.

CCHIT was created in 2004 by a coalition of HIT industry and professional associations to advance HIT adoption and enhance its value by establishing product certification criteria.  With HHS' recognition of CCHIT as an official certification body, any products that meet the Commission's criteria will be officially accepted under federal regulations.  The safe harbor regulations described above are the first example of how certification criteria will be applied.  HHS will recognize standards development by other groups, too, that—like CCHIT—have an open, consensus-oriented, multi-stakeholder decision-making process, as well as a transparent and well-documented testing and certification process.

Certification will generally focus on commercial off-the-shelf products.  While this will exclude potentially worthwhile homegrown products that could otherwise be offered to physicians, the value placed on interoperability does make it necessary to move to more standardized technology applications across the health care system.

The first set of CCHIT criteria applies to electronic health records in ambulatory care settings; in July, the Commission announced the first round of vendor products certified as complying with these criteria in four categories: functionality, interoperability, security, and reliability.  Additional products will be recognized as they are tested and meet certification requirements.  Future CCHIT efforts will establish criteria and recognize vendor products for inpatient HIT systems and health information exchange networks.

While CCHIT focuses primarily on functional and operational requirements for HIT, the American National Standards Institute (ANSI) has convened a panel to make recommendations on data standards for interoperable health information systems and on requirements for the proposed Nationwide Health Information Network.  ANSI's HIT Standards Panel will look, for example, at  data terminology requirements, to facilitate exchange of health information across systems.  Data standards and systems certification criteria are both needed to assess and monitor system performance at individual provider and network levels alike.  We will continue to report on these evolving activities in future issues of Qual-IT.

American National Standards Institute Health Informatics Standards Board.  Information on the Health Information Technology Standards Panel is available online at http://www.ansi.org/standards_activities/standards_boards_panels/hisb/hitsp.aspx?menuid=3

Centers for Medicare & Medicaid Services.  The safe harbor final rule is accessible online at http://www.cms.hhs.gov/PhysicianSelfReferral/Downloads/CMS-1303-F.pdf

Certification Commission for Health Information Technology.   Information on certified EHR products for ambulatory care, and the initial analysis of criteria for hospital inpatient HIT systems, is available online at www.cchit.org

Department of Health and Human Services Office of Inspector General.  The safe harbor final rule is accessible online at http://oig.hhs.gov/authorities/docs/06/OIG%20E-Prescribing%20Final%20Rule%20080806.pdf

The White House.  2006.  Executive Order: Promoting Quality and Efficient Health Care in Federal Government Administered and Sponsored Programs.   Accessible online at http://www.whitehouse.gov/news/releases/2006/08/20060822-2.html