A day before the Dec. 31, 2009 deadline for HHS to adopt an initial set of electronic health record standards, CMS and the Office of the National Coordinator for Health IT 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. The interim final rule took effect on Feb. 12 -- 30 days after its publication in the Federal Register, and comments on the proposed rule are being accepted until March 15.
As health care providers and vendors ramp up in an effort to meet the regulations to qualify for Medicare and Medicaid incentive payments under the 2009 federal economic stimulus package, there is still one big missing puzzle piece -- guidance on the EHR certification process.
What's the Hold Up?
Certification Commission for Health IT Chair Mark Leavitt said, "I am .... disturbed that ONC has allowed this delay to transpire in developing the accreditation process and publishing it and making it possible for certification programs to be accredited because I think it really counteracts their need to have this incentive program picked up by lots of providers." He added, "It's so surprising because of all the things they had to do, some things were already ready -- certification was already ready, standards were already ready."
However, American Medical Informatics Association President and CEO Ted Shortliffe said, "I think we have every reason to believe that they know this is important and that it does have to play a role in the meaningful use criteria which are out for rulemaking now so I can't imagine that it would be too long."
In an e-mail to iHealthBeat, National Coordinator for Health IT David Blumenthal said, "Because we are in rulemaking, I cannot comment on the certification process except to say that we are working as hard and fast as we can to develop a notice of proposed rule-making on this issue."
Meanwhile, another ONC official said on background that the Notice of Proposed Rulemaking describing the process for authorizing EHR certification bodies is going through final review and will be released soon.
Shift to Multiple Certification Entities
Founded in 2004, CCHIT has been the only government-recognized group to certify EHR products. However, it appears that will soon change. In August 2009, the Health IT Policy Committee adopted recommendations from its certification and adoption work group to authorize multiple entities to certify EHR systems.
When recommending the change to the current certification process, members of the Policy Committee work group said that CCHIT's certification process is overly detailed, though they noted that group's processes are fair and transparent. Some industry officials also have said that the current certification process is prohibitive to smaller EHR vendors.
In addition, the commission has been criticized for being too closely aligned with the health IT industry. The Healthcare Information and Management System, an industry trade group, helped found CCHIT, and the commission's members include several people with ties to HIMSS and health IT firms. The Policy Committee work group said, "While we did not see any evidence that vendors were exerting undue influence on CCHIT, we also understand that the appearance of a conflict is important to address."
Leavitt dismissed such complaints, saying, "We've responded to the criticism repeatedly with the facts, and the facts simply don't support the accusations." He said, "Two-thirds of the vendors that we certify are small businesses with under $10 million in revenue." He added that some vendors have told the commission that the certification process actually encouraged them to move into the market and sometimes even helped them acquire rounds of funding.
Leavitt said the suggestion that vendors should not be included on the commission "is akin to saying ... you should regulate something with no knowledge of the industry you're regulating." He added, "If you don't have participation from the very sector that you're affecting -- and not dominance by them but fair participation -- I don't think that you can create a practical and fair and balanced program."
Still, Leavitt said CCHIT understands the planned shift to a certification process with multiple EHR certifying entities. He said, "We think it's really understandable given the size of the [federal stimulus package's health IT] incentives which number in the tens of billions of dollars that they want to make sure that there's adequate capacity for certifying products, and I think they just didn't want to be in the position of blessing one certification body without having a transparent process to it."
CCHIT's Role Going Forward
Leavitt said that CCHIT fully expects to be accredited as one of the government-authorized certification bodies. He said, "I can't understand how anyone would be accredited and we wouldn't be since we have the most experience at it."
Shortliffe agreed with Leavitt's assessment, saying that "there's every evidence that at this point CCHIT will be part of any solution on certification."
Leavitt noted that CCHIT has "moved ahead and updated [its] certification programs to synchronize them to the criteria and standards in the interim final rule." The commission launched the new certification program on Feb. 12 and already has received applications, according to Leavitt.
He said CCHIT also will continue to offer a separate "comprehensive" EHR certification program that goes beyond the government criteria for qualifying for federal incentive payments.
Other Potential Certification Bodies
In November 2009, the Drummond Group -- a Texas-based interoperability test lab -- announced that it plans to apply to become an EHR certifying body.
Beth Morrow, co-founder and president of the Drummond Group, said her organization was contacted by several vendors that were familiar with its work and looking for options for EHR certification.
She said in an e-mail that the "Drummond Group has been actively testing, auditing and certifying software solutions for over 10 years in a variety of industries, and we feel very comfortable with the type of testing required for EHRs." Morrow added, "We have actively been working on test plans and tools and [have] spoken with contacts within the ONC. They are aware of our ongoing interest."
Shortliffe said that "organizations like the Joint Commission that already play a significant role in oversight of systems and their implementations could play a role" in future certification efforts. He also noted that "there could be new entities developed that are designed with a slightly different representative base perhaps than CCHIT."
However, he cautioned that the certification process could become "unwieldy or confusing to people." Shortliffe said, "So whatever gets created has to be pretty authoritative, and [it] has to be pretty straightforward what your options are and why you should choose one option over another."
Calls for Other Changes
Shortliffe said that EHR certification should take into account implementation of systems, not just the individual vendor products. He said, "We've known anecdotally for years that a product that seems to work very well in one institution has problems in another and that almost always suggests that the challenges have to do with the implementation, the cultural change and the process re-engineering that goes on within an organization when they attempt to implement these products."
Shortliffe said, "So we see certification as a process that has to span not only across what the vendor products do but also to the individual complex implementations."
AMIA also believes that the certification process should include "a balanced view of the importance of reporting quality and safety along with the efficiency issues involved with actually using" EHRs, Shortliffe said.