Is your EHR meaningful use-compliant? Healthcare providers may soon be able to find out for sure.

HHS released a proposed rule Tuesday for establishing certification programs for health information technology. The proposed rule describes the creation of a certification program for EHRs, as mandated by the HITECH Act.

EHR certification is designed to “give purchasers and users of EHR technology assurances that the technology and products have the necessary functionality and security to help meet meaningful use criteria,” according to a press release from the Office of the National Coordinator (ONC) for Health Information Technology.

When writing the interim final rule on standards and certification criteria for EHRs, the ONC strived to balance competing agendas, David Blumenthal, MD, MPP, the national coordinator for health information technology, said today at the Healthcare Information and Management Systems Society (HIMSS) 2010 Annual Conference and Exhibition in Atlanta.

For example, it tries to balance the need for uniform standards against the need for interoperability and innovation and the need for an efficient way to exchange information versus patients’ rights to privacy. The agency tried to allow for flexibility, to meet providers “where they are,” and not inhibit “critical innovation,” he said.

Similar to the multi-stage approach proposed for the EHR meaningful use incentive program, the proposed establishment of an EHR certification process would also occur in various phases.

• The first phase would be a temporary certification process whereby the National Coordinator would approve organizations to test and certify EHRs.
• The eventual permanent program would transfer testing and certification fully to private sector organizations and separate the two functions.

The separation of those two functions is an important aspect, Blumenthal said. It allows certification of not only completed EHRs, but also of individual modules, a move designed to allow architectural innovation.

The proposed permanent program also has requirements for accreditation and addresses the potential certification of health information technology (HIT) other than complete EHRs and EHR modules.

HHS anticipates issuing separate final rules for each of the two programs.

The multi-phase system is designed to enable eligible professionals and hospitals to implement certified EHRs in time to qualify for the initial set of meaningful use incentives, which are set to begin as early as October for hospitals, and January 1, 2011 for eligible professionals.

The phased method is a sound way for HHS to work within the regulatory timelines put in place by the HITECH Act, says Frank Ruelas, director of compliance and risk management at Maryvale Hospital and principal of HIPAA Boot Camp in Casa Grande, AZ. “It’s an ambitious program, so this approach works well.”

Because HHS made such a conscious effort to solicit input from so many different parties and such a wide variety of stakeholders, it injected an element of practicality into the rule, according to Ruelas. In addition, the rule takes care to consider the evolving meaningful use criteria and how the adoption of future criteria may affect the certification status of EHR systems or modules, he says.

One element of the program the healthcare community is likely to find particularly helpful is the proposed master “certified HIT products list” that the ONC plans to have publicly available on its Web site.

“This ONC master list will help folks accurately identify genuinely certified products that may help meet their needs, such as in achieving meaningful use,” says Ruelas.

The ONC expects it will add additional features to the Web site over time, such as interactive functions that would allow providers to review combinations of certified EHR modules to verify that they would comprise a certified EHR technology.

Interested parties will have 30 days after the proposed rule’s publication in the Federal Register to comment on the proposed temporary program, and 60 days to comment on the proposed permanent program. You can submit comments electronically at www.regulations.gov.

Blumenthal made it clear that HIT leaders must step forward to provide feedback for the proposed rules; throughout the document, there are questions directed at HIT leaders and requests for feedback.  “We want you to continue to be leaders and we will follow your lead,” he said.

With the release of the proposed rule, the focus now shifts from policy to the process of implementation, said Blumenthal, who expects the release of the three related EHR meaningful use final rules later this spring. His soon-to-be expanded office will now begin working on the next iteration of meaningful use.

“That is a huge job. We are going to have to grow considerably to make that happen,” he said.

Above article publish on http://www.healthleadersmedia.com/page-2/TEC-247430/Proposed-EHR-Certification-Program-Wont-Inhibit-Innovation-Says-Blumenthal

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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