ATLANTA -- The big news at the annual Healthcare Information and Management Systems Society conference on Tuesday wasn't the snowy weather hitting Atlanta, but the surprise announcement from National Coordinator for Health IT David Blumenthal that the long-awaited Notice for Proposed Rulemaking on the electronic health record certification process had been released.
Blumenthal told a packed conference room gathered for the already scheduled Office of the National Coordinator for Health IT Townhall yesterday afternoon that he had just learned that the NPRM officially had been made available to the public.
Earlier in the day, Jodi Daniel, director of ONC's Office of Policy and Research, told HIMSS attendees that ONC was "working as quickly as possible" to finalize the health IT certification program and that the NPRM on the certification programs was "coming very soon."
During a HIMSS session on Monday, Rep. Tom Price (R-Ga.), an orthopedic surgeon, said that because of ONC's delay in issuing guidance on the certification process, members of Congress plan to send a letter to federal officials asking them postpone the start date for when health care providers must begin demonstrating meaningful use to qualify for incentive payments included in the federal stimulus package.
Price said members of Congress are currently collecting signatures for the letter and could send it to HHS within a week.
In December 2009, CMS and ONC released a proposed rule describing how providers can demonstrate "meaningful use" of EHRs and an interim final rule describing the required certification standards for EHR technology, but until yesterday, the health care industry still was waiting for guidance on the EHR certification process.
Details of NPRM Certification
The 184-page NPRM proposes the establishment of two certification programs -- a temporary certification program that would test and certify EHR products to ensure that health care providers are able to adopt certified EHRs in time to qualify for the meaningful use incentive payments in 2011 and a permanent certification program that eventually would replace the temporary certification program.
The permanent certification program would separate the responsibility for performing testing and certification of EHR systems as recommend by the Health IT Policy Committee and the National Institute for Technology and Standards.
However, Steven Posnack, an ONC policy analyst, said that organizations would be allowed to perform both testing and certification if they would like, but they would need to receive accreditation for both separately.
According to the rule, "Any organization or a consortium of organizations that can successfully demonstrate competency with internationally recognized standardized certification and testing standards and methods are encouraged to apply for either or both certification programs."
In a statement sent to iHealthBeat, Alisa Ray, executive director of the Certification Commission for Health IT, said, "Having reviewed the Notice of Proposed Rulemaking regarding certifying bodies, we feel confident about our prospects of becoming accredited." She added, "We plan to file an application with ONC as soon as they are ready to accept them."
Posnack said that the NPRM would be published in the Federal Register in seven to 10 days, after which a 30-day public comment period for the temporary certification program and a 60-day comment period for the permanent certification program would begin.
ONC officials said they plan to issue the final rule for the temporary certification program at the same time the department issues final rules for meaningful use and standards and certification criteria.
Health IT Regulatory Review
Earlier in the day -- before the release of the certification NPRM -- officials from CMS and ONC briefed HIMSS attendees on the health IT regulations that already had been issued.
The session, titled "Health IT Regulatory Review: Updates and Next Steps," provided attendees with an overview of CMS' NPRM on the meaningful use of EHRs and ONC's Interim Final Rule describing the required certification standards for EHR technology.
Daniel stressed that ONC and CMS worked closely together to ensure that the meaningful use objectives and certification standards and criteria are aligned appropriately.
For example, electronic prescribing is a meaningful use objective so the certification criteria requires the capability for e-prescribing and the standards mandate that NCPDP Script 8.1 or 10.6 is used.
When asked by audience member what the agencies will do when there is "inevitably" a disconnect between the rules, Daniel said ONC and CMS would update the regulations on a periodic basis and could release guidance on the regulations to clarify any questions or confusion.
Tony Trenkle, director of CMS' Office of e-Health Standards and Services, called the regulations a "very complex undertaking." He said that there are "obviously a lot of moving parts here" and that the two agencies are working closely together to "define, refine and change" the rules over time.
Standards Town Hall
Meanwhile, in one of the first sessions of the day, John Halamka -- chair of the Health IT Standards Panel, co-chair of the Health IT Standards Committee and CIO of Harvard Medical School -- discussed the progress and status of health IT standards.
He noted that the U.S. has been working on health care standards "since about 1970." He said, "It's actually been a long road."
Halamka called 1970 to 1995 the "formation phase" and 1996 to 2009 the "coordination phase."
According to Halamka, the next phase -- 2010 to 2015 -- will include:
- The end of the comment period on health IT standards;
- New request for proposals, such as the creation of a new harmonization organization;
- A new framework for harmonization, conformance testing, specifications writing and tools; and
- The evaluation of the Nationwide Health Information Network.
Near the end of his presentation, Halamka offered the following lessons that he's learned while working on standards over the past five years:
- Standards are not imposed, they are adopted;
- Standards should be harmonized and commissioned standards based on clearly articulated priorities (use case vs. meaningful use);
- Adoption is accelerated by tools, including vocabulary registries and easy-to-use sources for implementation guidance;
- Keep it as simple as possible but no simpler -- the parsimony principle; and
- Perfection is the enemy of the good.
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