Working with ONC on HITECH: Some Observations
I have spent a large portion of the last eleven months working with the Office of the National Coordinator for Healthcare Information Technology (ONC) to develop the regulations and grant programs that resulted from the HITECH legislation. This time and this work have led to four major observations.
The Power of Meaningful Use
For decades, the healthcare information technology industry has tracked adoption. How many hospitals have adopted CPOE? What is the adoption rate of personal health records?
While adoption is a measure of industry uptake of a technology, it has an obvious flaw. Adoption does not mean that providers are using the technology or that care is being improved. Adoption does not, per se, lead to complete problem lists or providers doing a good job of managing the health of their patients.
Meaningful Use is a very potent idea. It says that if our goal is care improvement, adoption is only relevant if the technology is used well.
Meaningful Use also stops short of initially basing incentives on changes in care outcomes. While providers must report quality data, early stages of Meaningful Use do not require that specific improvements in care occur. It was understood that broad care improvement will take more time than is likely to be achievable under the initial HITECH timetables. And it was understood that while EHRs are an essential foundation for care improvement, additional factors must also be present.
Most importantly, payment reform must happen — reimbursement that explicitly rewards providers for improvements in care quality, safety, and efficiency. The recently passed Health Reform legislation begins the process of the implementation of payment reform for federal programs.
Meaningful Use moves the industry away from a focus on adoption, but does not overstep that movement by leaping all the way to outcomes.
The Joint ONC/CMS Approach to Regulation/Rule Development
After HITECH passed. there was a need to develop the regulations (also known as rules) that translated the legislation into specifics, e.g., what are the specific things a provider would have to do to be considered a Meaningful User?
As it writes rules, the government must follow a core protocol. Those who are drafting the rule cannot talk, outside of government, about the draft language. The draft rule must be reviewed and approved by several government departments such as the Office of General Counsel. And the government must ask for comments, on a draft of the rule, from the public and it must read those comments.
While it followed that protocol, ONC (and CMS for Meaningful Use) made a critical strategic addition. They leveraged the Policy and Standards Committees (which were open to the public) to develop recommendations of the rule content. The Meaningful Use Work Group defined an approach to the 2011 (Stage 1) objectives and measures. The Certification and Adoption Workgroup developed recommendations for a new EHR certification process. The Workgroups of the Standard Committee developed recommended data, transaction, quality measures, and security standards.
Most of the time, government does not do this. Generally government staffs do not precede rule writing with external committee (and public) input.
Why did ONC do this?
First, the rule content is likely to be better if it is based on the contributions of individuals who represent the broad spectrum of stakeholders in healthcare. These individuals “live” the delivery, financing, supplying, and management of care every day. And their experiences and knowledge cannot help but make the rule better. Moreover, the discussion of rule specifics from different perspectives helps to ensure that the rule balances, as well as it can, the variety of stakeholder interests.
Second, it is good government. Good government is transparent. Government is put in place by the people and it exists to serve the people. The people should be able to “drop in” on regulation deliberations and government should minimize the times it closes the doors.
Third, it is a terrific example of risk mitigation. It is very difficult to develop, for example, the specifics of Meaningful Use in a way that understands the complexity of healthcare; its current reality and its aspirations. By seeking the advice of experts through Committees and Committee testimony and inviting the comments of all, the Government is asking about areas where the proposed rule may have unintended consequences or could lead to sub-optimal outcomes.
Fourth, it helped the industry know, as early as possible, the direction that the rules were likely to take. The recommendations of the Committees were presented in the summer of 2009. The draft rules were unveiled in the winter of 2010. Through its use of the Committees, ONC was trying to give the industry as much of a lead time as it could.
The Complexity and Scope of the Challenge
HITECH has resulted in two classes of ONC efforts: definition and implementation.
HITECH required that specifics (and hence rules) be defined for
- Meaningful Use
- The data, transactions, and measures standards needed for health information exchange and quality reporting
- Certification standards and the certification process, and
- Privacy and security.
While essential, rules are not enough. Other actions are needed if we are to have the broad achievement of Meaningful Use by providers across the country.
Most of the care in this country is delivered by small physician groups and hospitals; they do not have an IT staff. Regional Extension Centers have been established to provide necessary support to those providers.
A health information exchange infrastructure needs to be in place to support the secure movement of data necessary for the care of an individual patient and the management of populations by public health organizations. Funds have been given to the states to establish this infrastructure and a plan to establish an over-arching National Health Information Network (NHIN) is being developed.
The country will need to increase the size of the work force available to support the broad achievement of Meaningful Use. Funds are being awarded to educators to provide necessary training and curricula.
Beacon communities will help us understand how best to leverage the technology to improve the health of a community and will teach us how to address important issues of governance, data use, and coordination of care.
Advanced health information technology research centers (SHARP) will provide ground breaking research into the critical areas of security, new architectural models, decision support, and secondary uses of data.
These implementation activities are breathtaking in their scope and sophistication. And the activities are the result of a very astute assessment of the range of “levers” that should be applied to achieve Meaningful Use.
However, initiating that many diverse initiatives that individually and collectively have a significant impact on multiple parts of the industry comes with some risk.
It is not possible to launch this much activity of this scope with this many actors and have great certainty about the outcome. This uncertainty will be magnified by the actions of the private sector — hospitals, health plans, suppliers, and others that are engaging in a diverse array of often very imaginative implementation activities.
The ONC implementation plans are very good plans. But they bring complex and substantial change to the industry. Change of this magnitude will bring very real progress, but it will also bring a period of time that is likely to be bumpy.
When significant change is introduced, one plans as well as one can, ensures that one has a realistic appreciation of the uncertainty, and preserves the agility to change course as needed. And, most importantly, one makes sure that there is ongoing dialogue with all stakeholders about issues, answers, and progress.
The Caliber of Federal Government Employees
Perhaps like many of you, I might have had this mental image of a typical government employee — a person with a rubber stamp in their hand and a scowl on their face. That mental image is wrong.
The people I worked with at ONC, CMS, NLM, NIH, FDA, DoD, VA, and a host of other government agencies and departments are exceptional. They are very smart and skilled. They work incredibly hard. They feel a sense of urgency. And they care deeply about making the country better. They listen thoughtfully to the comments, testimony, feedback, and articles from those who care about healthcare because they want to get it right.
They made me proud of my government because my government (and yours) is them.
John Glaser, PhD, FCHIME is vice president and CIO at Partners HealthCare System. He describes himself as an "irregular regular contributor" to HIStalk.