By Joseph Conn / HITS staff writer

The Certification Commission for Health Information Technology is adopting a two-tier system of testing and certifying IT systems.

In a conference call with vendors and developers of health IT systems Thursday, CCHIT Chairman Mark Leavitt announced the not-for-profit organization’s new testing program, as the group readies itself for the new realities of the healthcare IT market since passage of the American Recovery and Reinvestment Act of 2009.

One testing and certification program, dubbed Preliminary ARRA 2011 Certification, will specifically test for compliance with what is expected to be—at least initially—a fairly limited set of criteria that HHS and the CMS will use to determine eligibility by hospitals and office-based physicians for an estimated $34 billion in federal subsidy payments for the purchase of EHRs under the stimulus law.

The other, the so-called CCHIT Certified 2011 testing program, will use an elaborate set of about 300 criteria, primarily developed by the organization since its founding, that will closely resemble previous CCHIT testing and certification programs. The core CCHIT criteria will be tweaked to ensure systems that pass muster for its more advanced testing program also will meet ARRA requirements.

When it began testing IT systems in 2006, and on through 2008, CCHIT had offered just one, gold-standard set of criteria for each type of EHR system it tested—ambulatory EHRs or inpatient EHRs, for example.

But by April, CCHIT announced it would halt further testing to adapt its systems to accommodate the stimulus law criteria, development of which remains a work in progress. At the time of the announcement, Leavitt said the organization would keep its full-featured certification program, but would add two new testing and certification regimes scaled down to meet the minimum requirements of the stimulus law.

One new program would have tested IT systems by “module” against the new criteria under the recovery act, which requires providers to put “certified” EHR systems to “meaningful use” in order to qualify for federal subsidy payments. The proposed new modular approach was expected to appeal to some physician office practices and, more commonly, to hospitals, that want to piece together a comprehensive IT system from component parts produced by multiple IT vendors.

The other new CCHIT regime would have offered “on-site” testing and certification of EHR systems—again, against the less stringent stimulus law criteria with an eye toward qualifying for federal subsidies. This form of testing would have been conducted on systems installed at physician offices or hospitals. It was an approach targeted to appeal to providers who have developed their own EHRs or planned to assemble an EHR from noncertified sources, and to the open source development community, according to CCHIT.

According to Leavitt Thursday, CCHIT’s testing scheme will be modified again, but only somewhat. While site certification has been dropped as a certification scheme in and of itself, “site certification is still there,” Leavitt said. “In Preliminary ARRA Certification 2011, you can get a product or a site certified.”

Leavitt said it’s unclear whether providers adopting EHRs that have passed the test under the more rigorous CCHIT Certified 2011 program would want on-site certification, but if there is demand for the service, CCHIT will provide it.

Starting in June and running through its latest report in August, the HIT Policy Committee, which was created under the recovery act, has issued three sets of recommended definitions of meaningful use. Some of those recommendations have been controversial. To have market relevance, however, any program of certification of EHR systems that CCHIT develops must take those meaningful use standards into consideration to ensure that certified systems will enable providers to meet meaningful use standards and qualify for federal subsidies. The meaningful use standards, ultimately, will be developed by the CMS, which is tasked with running the bulk of the EHR subsidy program through Medicare and Medicaid.

In addition, CCHIT has to keep an eye on the Office of the National Coordinator for Health Information Technology at HHS, which, on behalf of the HHS secretary, will issue its own certification criteria for EHR systems, since, to qualify for subsidies under the stimulus law, providers also have to use “certified” EHR systems. Leavitt said CCHIT is forecasting ONC will issue its final rule on certification standards by Dec. 31 this year and that they probably will be the same or perhaps even less stringent than the recommendations the HIT Standards Committee made to ONC in August.

“We believe the final requirements will be the same as or less stringent that the current recommendations,” Leavitt said.

Both CCHIT testing and certification programs will open for vendor applications Oct. 7. Duration of certification is expected to run though Dec. 31, 2012, when certification criteria under the ARRA are expected to be ratcheted up, becoming both more numerous and more stringent.

Fees for certifying systems will vary with the certification scheme and the product, according to CCHIT Executive Director Alisa Ray. Under the CCHIT Certified 2011 program, the fee to a vendor to certify an EHR is $37,000 for either an ambulatory-care or an emergency department system, $49,000 for an inpatient system and $18,000 for an electronic prescribing system. Annual renewal costs are $9,000 for each, except e-prescribing, which is $7,000.

For Preliminary ARRA 2011 Certification, costs are pegged to the number of modules being tested, with fees set at $6,000 for one or two modules, $10,000 for three to five, $15,000 for six to 10, $24,000 for 11 to 20 and $33,000 for more than 20. Annual updates range from $1,000 to $5,000.

According to EHR vendor representative Justin Barnes, who listened in on Thursday’s CCHIT call, CCHIT probably has hit on the right strategy by launching its new testing and certification program this fall, based on an educated guess at what the government’s criteria might be, but before the final rules are published. Barnes is the chairman of the Electronic Health Record Association, and a vice president overseeing corporate development, marketing and government affairs for Greenway Medical Technologies, a Carrolton, Ga.-based EHR system developer.

“The detail that we have right now around meaningful use, you really can’t write a product to it,” Barnes said. “The interim final rule will come down at the end of this year. I think that will be a fairly close definition that we could follow. I think it will be plenty to work off of. The certification process, I believe, will be tweaked a little bit as well.”

Barnes said he hopes Leavitt is right when he predicts the ONC and the CMS will not vary too far from the current recommendations in writing the preliminary rules. He also said he hopes they don’t dally in unveiling their preliminary rules so everyone involved, both EHR vendors and users, have time enough to act.

“If there are any discrepancies, that could pose an interest to some people if you have to do heavy product development,” Barnes said. “It takes 12-plus months for the product cycle to add functionality on the ambulatory side and 18-plus months on the inpatient side. There is a word of caution here. That’s why we’ve urged ONC to move on this as fast as they can.”

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