American Association for Clinical Chemistry
Better health through laboratory medicine
February 2010 Clinical Laboratory News: Regulatory Profiles

CLN Banner Logo

February 2010: Volume 36, Number 2

Electronic Health Record Incentive Taking Shape

The Centers for Medicare & Medicare Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) announced two regulations that will help implement the electronic health record (EHR) incentive programs enacted under the American Recovery and Reinvestment Act of 2009 (Recovery Act).

Part of the Obama administration’s push for improved health information technology, physicians stand to gain from $44,000 to $64,000 each by demonstrating ‘meaningful use’ to CMS over a 5-year period, and hospitals may be able to get millions. Beginning in 2015, CMS will financially penalize providers who don’t show meaningful use of EHRs. Incentive payments may begin as soon as October 2010 to eligible hospitals, while incentive payments to other eligible providers are slated for January 2011.

The most anticipated and controversial element of the program has been how CMS would define ‘meaningful use’ so that physicians and hospitals will know that their investments in EHRs will measure up and earn the rewards. The new regulations include a proposed rule that finally defines the central concept of meaningful use of EHR technology. The other regulation, issued by ONC, sets initial standards, implementation specifications, and certification criteria for EHR technology. Both regulations are open to public comment through the end of February.

It will not be easy to meet the definition of meaningful use. The proposed rule requires that the physician or hospital demonstrate use of certified EHRs in a way that improves quality, safety, and efficiency of healthcare delivery; reduces healthcare disparities; engages patients and families; improves care coordination; improves population and public health; and ensures adequate privacy and security protections for personal health information.

The ONC regulation describes standard electronic formats for clinical summaries and prescriptions; standard terms to describe clinical problems, procedures, laboratory tests, medications and allergies; and standards for the secure transmission of this information using the Internet. It also sets forth how an EHR can be certified.

Both agencies noted that regulations will need to be updated over time as technology advances. The CMS proposed rule and fact sheets are available from the CMS website. ONC’s interim final rule may be viewed at the HHS website.

HHS Outlines First Health Security Strategy

Department of Health and Human Services (HHS) Secretary Kathleen Sebelius announced the national health security strategy, the nation’s first comprehensive strategy focused on protecting people’s health during a large-scale emergency. The plan sets priorities for government and non-government activities over the next 4 years.

Sebelius defined national health security as the nation and its people being prepared for, protected from, and resilient in the face of health threats or incidents with potentially negative health consequences, such as bioterrorism and natural disasters. The plan provides a framework that aims to build community resilience, strengthen and sustain health emergency response systems, and fill current gaps.

The national health security strategy and the accompanying interim implementation guide outline 10 broad objectives to achieve health security: foster informed, empowered individuals and communities; develop and maintain the workforce needed for national health security; ensure situational awareness so first responders are aware of changes in an emergency situation; foster integrated healthcare delivery systems that can respond to a disaster of any size; ensure timely and effective communications; promote an effective countermeasures enterprise; ensure prevention or mitigation of environmental and other emerging threats to health; incorporate post-incident health recovery into planning and response; work with cross-border and global partners to enhance national, continental, and global health security; and ensure that all systems that support national health security are based upon the best available science, evaluation, and quality improvement methods.

The strategy and implementation guide is available from the HHS website.

ISO Developing eHealth Resource for Developing Countries

The International Standards Organization (ISO) announced that it will create a technical report to help emerging and developing countries implement an internationally harmonized health informatics system. The report will present information in an accessible way to guide and facilitate the adoption of international standards by countries with limited resources and infrastructure. ISO will work on the document (ISO/TR 14639) in partnership with the World Health Organization.

The design, deployment, and maintenance of a national eHealth infrastructure can be a complex task, especially for those new to the area, ISO noted in the announcement. Scarce resources and IT expertise make it difficult to put together systems that are scalable, robust, and meet a country’s long-term needs. Most resource-limited countries have multiple “vertical systems”—programs geared to individual diseases like HIV—and lack a common framework that could improve data collection and reporting.

According to ISO, international standards can help by providing globally harmonized specifications for the architectural framework used to design eHealth systems, plan implementation, make “build-or-buy” decisions, and decide on acquisitions. More information is available from the ISO website.