Qual-IT - November 2005
Rapid Advances in the Federal and New York State HIT Policy Agendas
The steady but slow advance of health information technology (HIT) policy and protocols that marked the late 1990s and early 2000s has been significantly accelerated, recently, by new momentum in the federal HIT policy agenda. Through a series of largely coordinated steps taken in October 2005, several agencies and organizations have issued major policy recommendations, published draft regulations, and awarded grants and contracts, all focused on advancing the policy and technical framework for widespread adoption and use of HIT. This issue of Qual-IT highlights these recent federal activities and provides an update on major New York State policy developments as well.
In this issue
Breakthrough on Priorities
With last summer's announcement of the formation of the American Health Information Community (AHIC), Health and Human Services (HHS) Secretary Mike Leavitt brought together a diverse group of health care leaders to join with senior federal officials in developing strategies to accelerate HIT adoption and use. The Secretary described his vision of AHIC, during the group's first meeting on October 7, as wielding its large-bloc market power and fostering public-private collaboration to advance fundamental changes in how health care is delivered. Simultaneous actions to advance HIT adoption and interoperability will increase the value to be obtained from the improved quality, safety, and efficiency that such collaboration is expected to achieve, Mr. Leavitt emphasized.
The Secretary identified a proposed set of “breakthrough” steps that will produce "a tangible and specific value to the health care consumer" within two or three years, in three broad categories—consumer empowerment, health improvement, and public health protection; examples include development of personal health records and medication histories, widespread physician use of electronic health records and prescribing, and enhanced public health surveillance and monitoring of adverse drug events. Reflecting on his concerns about the public health threat associated with avian influenza, Mr. Leavitt announced that his first priority is to establish a national system for real-time web-based streaming of emergency room data to local, state, and national health agencies, to be operational by the end of 2006. AHIC is scheduled to meet again November 29.
Progress on Interoperability
The Commission on Systemic Interoperability, established within HHS in 2004 to develop a high-level roadmap for a national interconnected health information system, released its report last month (CSI 2005), delineating requirements for three broad components of the HIT agenda:
· Adoption. Training, technical assistance, and increased public awareness, to promote the use of electronic health information systems and tools by clinicians and consumers
· Interoperability. Promulgation of current and future data standards for electronic health records (EHR), and certification of these systems' functions and performance
· Connectivity. Standards for patient identification, privacy, and security of health information, and coordination at the national level to foster investment in the necessary infrastructure for an interconnected health information system.
Public-Private Partnerships
Consistent with the overall vision articulated by the Commission, HHS has awarded $17.5 million in contracts based on three of the four RFPs it released earlier this year. Designed to create public-private partnerships that will spur HIT adoption and interoperability, the contracts address both technical and policy issues:
· HIT Standards Harmonization. Variations and incompatibilities among existing HIT standards pose barriers to achieving widespread HIT adoption and interoperability. HHS has selected the American National Standards Institute (ANSI) to convene an HIT Standards Panel, which will develop, test, and evaluate a process for reconciling standards to support interoperability among software applications, including electronic health records. Under this $3.3 million contract, ANSI will bring together and consult with existing standards-setting groups and other health care stakeholders.
· HIT Compliance Certification. Although there are many EHR products on the market, no standards yet exist for evaluating their capabilities, including interoperability with other systems. HHS has awarded a $2.7 million contract to the Certification Commission for Health Information Technology to develop criteria and an evaluation process for certifying both EHRs and the networking components needed to achieve interoperability. Recommendations for these criteria will be completed by December; the evaluation process is to be developed by January 2006.
· Privacy and Security Solutions. An extensive array of federal and state laws and regulations governs the privacy and confidentiality of health information; numerous operational policies are in place throughout the health care system, as well, determining how these requirements are implemented in a given setting. To address these widespread variations in law and practice, and develop plans to eliminate conflicts among them, HHS has awarded $11.5 million to the Health Information Security and Privacy Collaboration, a consortium of health policy and legal experts, and to the National Governor's Association.
Electronic Prescribing and Safe Harbor Regulations
Under the Medicare Part D drug benefit legislation enacted in 2003, Part D plans are required to support electronic prescribing should physicians and pharmacies choose to use it; HHS is required to adopt standards for each functional area of electronic prescribing (e.g., prescription orders, eligibility queries, prior authorization). Based on a record of industry experience, three such standards have been advanced as ready for implementation in January 2006, in a proposed rule published for public comment on October 5 (HHS 2005). Additional standards will be pilot tested and could be included in future amendments to these regulations.
The Part D legislation also authorized certain exceptions to existing Medicare “anti-kickback” and self-referral policies, as they might apply to physician use of electronic prescribing. These policies were originally developed to prevent fraud and abuse by placing restrictions on various financial arrangements between physicians, and among physicians and hospitals. The existing requirements are widely viewed as creating barriers to HIT adoption, particularly by physicians, because they preclude financing incentives and the donation of goods and services that would otherwise assist physicians in acquiring and implementing EHR systems. Two additional proposed rules, also published last month, would make the Part D exceptions operational.
The first, addressing the self-referral prohibitions, would permit certain types of non-monetary remuneration for physicians—i.e., donations of hardware and/or software—if these items were necessary and used solely to send and receive electronic prescribing-related transactions and information; a parallel provision would cover the donation of these items if they were used to receive, transmit, and maintain information as part of an EHR system. Physicians' systems would also need to comply prospectively with any interoperability or certification requirements established by HHS.
The second proposal would establish similar protections for electronic prescribing under the federal anti-kickback law; parallel EHR provisions will be proposed at a later date. Once finalized and in effect, the two rules will create a regulatory environment designed to accelerate physician adoption and use of HIT, particularly with regard to electronic prescribing.
In summary, increased momentum on a number of national initiatives is rapidly advancing solutions in key policy areas described in the July 2004 HHS strategic plan for a national health information network (HHS 2004). Since then, broad consensus has been achieved on the overall policy framework for the plan, and specific steps have been taken to address some of the impediments to implementation. It remains worth noting, however, that the federal policy agenda for HIT has at least one major limitation: there is still no large-scale coordinated plan for financing of the HIT infrastructure.
New York State HIT Policy Developments
Meanwhile, at the state level, New York's Department of Health and the Dormitory Authority of the State of
· Purpose: Funding will be available on a competitive basis for projects that will help build the HIT infrastructure in New York, consistent with the HHS strategic plan. Emphasis is on community-wide clinical data sharing, electronic prescribing, and electronic medical records.
· Funding Amounts: A total of $52.875 million is being made available for this first phase of HEAL-NY; six regional areas have been defined and the total amount will be divided among those regions based on population. Individual projects can request grant funds for up to 50 percent of their total project costs; grant funds may cover up to 70 percent of total costs, however, when one or more participating organizations is financially distressed. Each grant will be funded at a minimum of $50,000, up to a maximum of $10 million. Funds are available for capital projects only; grants will not be awarded for planning, only for implementation.
· Evaluation Criteria: Each project will need to involve at least two distinct health care organizations (e.g., hospitals, physician groups, health plans). Applicants must also demonstrate how their projects will address key program goals, including reduced costs and/or utilization; improved health care quality and safety; support for interoperability, including the use of national standards as they are developed; and ongoing financial viability and sustainability of the project's business model.
Resources
CSI (Commission on Systemic Interoperability). 2005. Ending the document game: Connecting and transforming
your healthcare through information technology. Available online at
http://endingthedocumentgame.gov/report.html
HHS (Department of Health and Human Services). 2004. The decade of health information technology:
Delivering consumer-centric and information-rich health care. Framework for strategic action. Available online at www.hhs.gov/healthit/documents/hitframework.pdf
———. Office of the National Coordinator for Health Information Technology. 2005. e-Prescribing. Available online at www.hhs.gov/healthit/e-prescribing.html
Additional information about HHS health information technology initiatives can be accessed at www.hhs.gov/healthit
Information about HEAL-NY can be accessed at www.health.state.ny.us/funding/rfa/0508190240
Coming Next Month
An Assessment of the Evolving HIT Interoperability Landscape
