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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Bernie Monegain, Editor

The Certification Commission for healthcare information technology has announced that it will launch new certification programs on Oct. 7.

CCHIT officials announced Tuesday they will offer an updated comprehensive electronic health record certification program, called CCHIT Certified 2011, as well as a modular certification program – called Preliminary ARRA 2011 – that is limited to the standards for qualifying EHR technology under the American Recovery and Reinvestment Act (ARRA).

“There is a high risk that providers would not achieve meaningful use to qualify for the ARRA incentives in 2011 and 2012 if they wait until late 2010 to implement certified EHR systems and technologies,” said Mark Leavitt, MD, chairman of the commission. “On our town call Sept. 3, which drew over 700 attendees, we received valuable feedback on our proposed programs and a strong indication of interest from health IT companies and developers in applying for timely certification under these programs.”

Leavitt said the commission has followed the recommendations of the health information technology advisory committees to the Office of the National Coordinator (ONC) and believes there is sufficient information to offer preliminary ARRA certification.

HHS criteria and standards are slated for publication by the end of 2009. Final rules on meaningful use are expected in the spring of 2010.

If that process results in the introduction of new requirements, the commission will offer vendors with preliminary certifications an incremental inspection at no additional fee to bring their certifications into alignment with the final rules.

The commission’s certification materials, including criteria, test scripts and certification policies for both programs, will be published Sept. 24 on the CCHIT Web site. Applications for certification will open online on Oct. 7.

To help HIT companies and developers to make 2011-certified EHR technology available to providers, the commission is offering a workshop in the Chicago area on Oct. 1. The workshop, Get Certified 2011, is designed to orient companies and developers to the new certification process and help them use the new certification program tools effectively.

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By Ken Terry

While the debate over “meaningful use” of electronic health records rages on, it has been easy to forget the other half of the requirement for getting government health IT subsidies: Physicians and hospitals must use “qualified” EHRs.

Since the passage of the HITECH Act, part of last spring’s stimulus package, there has been speculation that a qualified EHR would have to be certified by the Certification Commission for Health Information Technology (CCHIT), which so far has been the only game in town. But the Health IT Advisory Committee, which advises the Department of Health and Human Services on information technology matters, has decided that there should be multiple certification bodies. All of them would have to certify EHRs under criteria developed by HHS.

According to the work group that made the recommendations approved by the whole committee, CCHIT’s criteria for certification are too detailed and the organization is too close to the industry to be the only certifying entity. Other observers have pointed out that CCHIT is very close to the Healthcare Information and Management Systems Society (HIMSS), a trade association for health IT professionals that include many software vendors among its members. In addition, Mark Leavitt, MD, chair of CCHIT, used to be a HIMSS executive and, before that, led an EHR company. However, there is no evidence that CCHIT’s ties with HIMSS have influenced its approach to certification, which has been implemented by workgroups that include a wide range of industry professionals.

In any case, CCHIT plans to certify EHRs under the criteria that will be established by HHS. Meanwhile, the advisory committee has asked CCHIT to submit a proposal for developing a “Preliminary HHS Certification” process that would allow it to provide preliminary certification to EHR vendors so that providers can begin purchasing qualified products, perhaps as early as October. In addition, the committee approved a plan to grandfather in vendors that have 2008 CCHIT certification, with the proviso that they upgrade their products later.

In a signifier of what this debate is really about, the committee has approved the certification of “open-source” EHRs, which contain non-proprietary code that is available to anyone who wants to use it. The best-known example in the healthcare arena is the VA system’s Vista EHR, which has been available to software developers for a number of years. In addition, the comment about CCHIT’s criteria being too detailed suggests that the committee wants to use looser criteria under which less advanced (and less expensive) EHRs could qualify for government aid.

I applaud this decision on a couple of grounds: First, continuing to tighten criteria for “qualified” EHRs would help a dozen or so vendors consolidate their hold on the market as providers sought EHRs that could garner government aid. Second, physicians don’t need all of the bells and whistles in current EHRs to improve health care. Relaxing the criteria in certain respects would help the development of nontraditional community EHRs, including those linked to disease registries, that might serve the purpose better. But as HHS develops its criteria, it should bear in mind that the EHRs that are qualified for government subsidies must also help doctors demonstrate meaningful use.

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The Certification Commission for Health IT is moving forward on plans to launch a less comprehensive certification program that will focus solely on compliance with the “meaningful use” requirements of the federal economic stimulus package, Health Data Management reports.

Under the stimulus package, hospitals and physicians who demonstrate meaningful use of electronic health records will qualify for Medicare and Medicaid incentive payments.

Although the federal government is not expected to issue a final definition for meaningful use until next spring, CCHIT aims to launch its new certification program in October.

CCHIT Chair Mark Leavitt said the commission will base its new program on preliminary recommendations from federal health IT advisory committees. He said this will allow health care organizations to purchase and implement EHR systems in time to receive the maximum incentive payments.

Leavitt added that CCHIT also plans to update and expand its current comprehensive EHR certification system for ambulatory, emergency department and inpatient settings (Anderson, Health Data Management, 8/25).

Recent Certification Changes

Earlier this month, the Health IT Policy Committee adopted recommendations that called for multiple entities to certify EHR systems. The certification and adoption work group said it envisions the establishment of 10 to 12 different EHR certification groups, in addition to CCHIT.

The Policy Committee also proposed a transition plan to help health IT vendors develop products that meet the 2011 meaningful use requirements.

Under the “Preliminary HHS Certification” process, CCHIT likely would provide interim certification for EHR vendors. The plan would invite CCHIT to submit a proposal for developing the preliminary certification process (iHealthBeat, 8/17).

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http://www.ihealthbeat.org/Articles/2009/8/26/Full-Steam-Ahead-for-CCHITs-New-Certification-Program.aspx

The Certification Commission for Health Information Technology is moving forward with plans to launch a new, less comprehensive electronic health records software certification program in light of the federal economic stimulus package.

In October, the commission plans to launch a more limited, modular inspection program for EHR software, focusing only on compliance with standards required for “meaningful use” of EHRs under the American Recovery and Reinvestment Act.

Rather than wait for the federal government’s final rule defining “meaningful use” of EHRs next spring, CCHIT is moving forward with its new certification efforts based on preliminary definition recommendations from federal HIT advisory committees, says Mark Leavitt, M.D., the commission’s chair. That’s because providers will have limited time to select and implement EHRs by 2011 to qualify for maximum Medicare and Medicaid incentive payments under ARRA.

CCHIT also will continue to update and enhance its existing, more comprehensive, EHR certification system for ambulatory, inpatient and emergency department settings, Leavitt said.

The Chicago-based commission will hold an online “town hall” meeting at noon September 3, when electronic health records vendors can learn about and discuss the two CCHIT certification efforts.

The commission’s action comes after the federal HIT Policy Committee’s certification/adoption workgroup recently recommended that multiple organizations offer “HHS Certification” testing of EHRs for the incentive program. The workgroup, in making its recommendation, said that CCHIT’s existing, comprehensive certification of EHRs should not be a requirement for incentive payments. Instead, software should be certified solely for achieving the minimum set of criteria to meet ARRA’s “meaningful use” standard, according to the workgroup.

But federal regulators have yet to make a final decision on a certification approach, much less designate whether CCHIT, or other organizations, will be the government’s recognized certification bodies.

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http://www.healthdatamanagement.com/news/CCHIT-38877-1.html

By Neil Versel

After months of being the target of critics both legitimate and questionable, the Certification Commission for Healthcare Information Technology is reasserting itself in the EMR marketplace. Last week, the federal Health IT Policy Committee signed off on recommendations from its Workgroup on Certification and Adoption that there should be multiple bodies to certify EMRs for participation in the multibillion-dollar Medicare and Medicaid EMR subsidy program authorized by the economic stimulus legislation. However, given the time it would take to start up a competing certification mechanism, the committee recommended that CCHIT take the lead for now in adapting certification to the “meaningful use” matrix that will determine whether a provider qualifies for stimulus money.

Meanwhile, CCHIT says it will update its certification criteria in October to meet the stimulus requirements for 2011, the first year of the subsidy program. The commission plans to respond to earlier criticism by adding certification options for some individual EMR components such as e-prescribing and clinical decision support. It also asked HHS to determine whether CCHIT’s existing criteria satisfy the 2011 requirements for meaningful use.

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http://www.fierceemr.com/story/cchit-advances-plans-2011-emr-certification/2009-08-20

Critics have complained that the Certification Commission for Health Information Technology is too closely aligned with large EMR vendors.

By Marianne Kolbasuk McGee

The Certification Commission for Health Information Technology, which has been the group providing a seal of approval for electronic medical record products since 2006, will continue to be the certification body for health IT systems at least until December when the U.S. government finalizes its definition of “meaningful use” of e-health products.

After the meaningful use definition is finalized, multiple organizations will be allowed to perform testing and certification of products for meeting the evolving criteria and standards of U.S. and Health and Human Services health IT certification rules. Vendors would need certification from only one certification body.

The continuation of CCHIT as a certification body was among the recommendations endorsed by the HIT Policy Committee certification and adoption workgroup during a meeting on August 14.

The HIT Policy Committee is an advisory board to the Office of Coordinator of National Health IT, which is guiding the U.S. Dept. of Health and Human Services on filling in the details of the $20 billion federal stimulus HIT legislation signed into law in February.

The non-profit CCHIT organization was founded in 2004 and began certifying products in 2006 during the Bush administration’s push for most Americans to have e-health records by 2014.

To date, CCHIT has certified more than 200 e-health products. However, with the passage of the American Recovery and Reinvestment Act ’s health IT legislation earlier this year, the future role of CCHIT was uncertain.

According to provisions in ARRA, in order for healthcare providers to be eligible for federal stimulus rewards starting in 2011, they must use “qualified” health IT products in “meaningful” ways. The details of qualified and certified–as well as “meaningful use” are still being hammered out. However, the HIT Policy Committee meeting last week helped clarify some of those ongoing questions, including the role of CCHIT at least in the short term.

Over the last few months, critics of CCHIT have complained to the HIT Policy Committee that CCHIT is too closely aligned with large EMR vendors selling comprehensive, feature-rich products, making it difficult or impossible, as well as expensive, for smaller vendors, open source developers and in-house development teams, who provide modular products with fewer bells and whistles, to get CCHIT certification.

CCHIT announced recently it will offer additional paths of certification for open source and modular products, such as e-prescribing, as well as in-house developed or assembled e-health systems.

In documents distributed at its Aug. 14 meeting, the HIT Policy Committee said that moving forward, the proposed definition of HHS Certification “means that the system is able to able to achieve the minimum government requirements for the security, privacy and interoperability, and that the system is able to produce the ‘meaningful use’ results the government expects.”

The HIT Policy Committee added that “HHS Certification is not intended to be viewed as a ’seal of approval’ or an indication of the benefits of one system over another.” Other recommendation by the HIT Policy Committee:

• The National Coordinator should determine the criteria for HHS Certification, which should be limited to the minimum set of criteria that are necessary to: (a) meet the functional requirements of the statute, and (b) achieve the Meaningful Use Objectives.
• The focus on Meaningful Use should reduce the barriers currently faced by vendors that focus on specialists.
• Criteria on functions/features should be high level; however, criteria on interoperability should be more explicit.
• These criteria should be updated as the definition of meaningful use evolves.
• Workgroup encourages the industry to continue to provide advisory services that can rate other aspects of EHRs that are important to purchasers, such as non-meaningful use features and functions and vendor viability and support capabilities.
• The Office of National Coordinator is encouraged to explore critical aspects of e-health records for which certification criteria may not exist today– for example, usability and improved models for system and data architecture.

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by Richard L. Lindstrom, MD

EMR, DICOM, SNOMED, HIPAA, CCHIT — how many readers can explain in detail what each of these means to their practice? While to date only a few more than 10% of us have fully adopted electronic medical records, by 2015 we will all face significant penalties if we are not fully engaged in this next government mandate.

We at Minnesota Eye Consultants are still delaying implementation of electronic medical records (EMRs), partly because the costs are staggering, the technology available for ophthalmology is in evolution, and especially because of the horror stories we have heard from so many of our colleagues who have made the attempt to go electronic in the past. I am concerned that the penalties may be significantly greater than just the astronomical cost of implementation and the potential for reduced reimbursement for those who are noncompliant.

I am now old enough to have a few medical maladies of my own — hypertension for one, well managed on medical therapy, and a few sports injuries requiring joint surgery. Just this last week, I visited my internist who is part of a large multispecialty clinic that adopted EMRs 2 years ago. As I sat in the examination room, first the nurse and then the physician recited a long list of required questions while seated in front of a computer monitor, the whole time intent on the monitor and keyboard, without once looking up at me as they completed the history. Clearly, to me, this was a major disconnect in the way I have classically interacted with patients in our currently non-EMR clinic. Of course, there was an examination and a little laying on of hands with a few follow-up questions. Then another 5 minutes for me to look at the back of my physician as the data was entered and the treatment plan formulated.

On a positive note, a summary of the plan of therapy was immediately printed and handed to me, and the physician, one of the best internists in Minnesota, did turn and look me in the eye as he went over the plan and answered any questions. Having a good relationship with this committed physician, I asked him what he thought about EMRs. After a long sigh, which was in itself the answer to my question, he conceded that on the positive side, EMRs were a potentially powerful tool for large multi-specialty clinics such as his, where multiple providers at multiple locations participate in a single patient’s care. All caregivers at all locations have access to all the data immediately once it is entered. He admitted it was also a constructive tool for monitoring physician productivity and patterns of care, providing a powerful data set to those managing and regulating our practices.

The negatives were, however, even more important. He felt that he had lost significant rapport with his patients because he was required to enter so much data, which was an extremely time-consuming task. On many days, he felt more like a data entry clerk than a highly valued clinician. I certainly had to agree with him on this point, as two-thirds of my time with him had been devoted to data entry and only one-third to utilizing his training and skills as a physician. In addition, he said the data entry tasks had negatively affected his efficiency significantly, requiring him to reduce the number of patients he could schedule in a day.

His overall analysis: The EMR winners are management, regulators and third-party payers. The losers are patients and physicians. The bottom line: An easy-to-read computer-generated medical record does not guarantee high-quality personalized patient care.

So, at a cost of billions to physicians and surgeons already struggling to remain solvent, we enter into an era of more depersonalized care and reduced physician efficiency and productivity. Perhaps in time with dedicated physicians, increased experience, the use of scribes (which will also increase costs) and advances in voice recognition technology so that we can again look our patients in the eye when we talk with them, we will make EMRs a positive for the patients we care for every day. But for now, for most of us, it will simply be another government-mandated cost and inappropriate intrusion into the practice of medicine with no clearly demonstrated benefit to physicians or patients in regard to quality of care or patient satisfaction. No surprise, but disappointing nonetheless.

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Gordon Gillerman — chief of the standards division of the National Institute of Standards and Technology — said officials might push for an accreditation organization to oversee the Certification Commission for Healthcare IT, Modern Healthcare reports.

Gillerman delivered a presentation for the Health IT Policy Committee’s certification and adoption work group.

He said an organization such as the American National Standards Institute could serve as a watchdog for CCHIT.

Gillerman added that he does not foresee NIST becoming involved in accrediting certification groups. Rather, he said, NIST could help the Office of the National Coordinator for Health IT develop an appropriate accreditation process (Conn, Modern Healthcare, 7/14).

CCHIT as Sole Certifier

In related news, the Electronic Health Record Association on Monday sent a comment letter to the Health IT Policy Committee’s certification and adoption work group urging officials to designate CCHIT as the single certifying body for electronic health records.

The EHR association is part of the Healthcare Information and Management Systems Society, which co-founded CCHIT.

The EHR group said it “supports CCHIT as the single certifying entity to avoid duplication of effort, unnecessary expense and confusion in the market.”

The association added that CCHIT certification should ensure that a health IT system “is a qualified, comprehensive EHR and is capable of enabling providers to achieve ‘meaningful use’ requirements” (Goedert, Health Data Management, 7/14).

Other Recommendations

The EHR Association’s comment letter also offered recommendations for developing criteria on the meaningful use of EHRs.

The association called for 2011 EHR objectives to:

Differentiate between inpatient and ambulatory care criteria;

Emphasize existing software and standards; and

Focus on adoption and use of comprehensive systems.

The group also recommended linking computerized physician order entry systems to electronic medication administration records and data on chronic diseases.

The Health IT Policy Committee is scheduled to release its second draft definition of meaningful use during a meeting on Thursday (Merrill, Healthcare IT News, 7/14).

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http://www.ihealthbeat.org/Articles/2009/7/14/Groups-Weigh-In-on-Meaningful-Use-EHR-Certification-Entities.aspx

By Jonathan D. Epstein NEWS BUSINESS REPORTER

Western New York’s three health insurers have asked the region’s electronic clinical information exchange to lead an effort at driving more adoption of electronic medical records by area physicians.

Western New York Health Plans, comprised of HealthNow New York, Independent Health Association and Univera Healthcare, hired HEALTHeLINK to implement a program seeking to get 500 more doctors to start using electronic medical records over the next three years.

That’s part of a nationwide effort by the government, insurance industry and providers to increase the use of electronic records to lower costs, streamline operations and reduce medical errors. While use of the electronic records is spreading locally, so far it’s been limited to a few major practices, such as Buffalo Medical Group.

“It’s certainly not at the rate that we wanted, so that’s why this is an exciting opportunity that the health plans are providing to the physicians,” said Daniel E. Porreca, executive director of HEALTHeLINK.

Under the agreement, HEALTHeLINK will help the health plans select the vendor software packages that physicians can choose from, including determining the requirements used to evaluate them. For example, the software must help providers produce better medical outcomes, and also support personal health records and electronic prescribing.

HEALTHeLINK will also guide physicians in choosing which software to use, and then implement so they can qualify for federal dollars.

Congress set aside $19 billion in the $787 billion stimulus package, called the American Recovery and Reinvestment Act of 2009, to support doctors and hospitals in adopting electronic records. President Obama signed the measure into law on Feb. 17.

“We believe our agreement with HEALTHeLINK, coupled with the recently passed federal stimulus package that will provide physicians reimbursement for adopting electronic medical records, will help ease this technological transition for the physician community,” HealthNow executive vice president Cheryl A. Howe said in a press release.

The new initiative will focus on primary care physicians, Medicaid providers and eventually specialists, including both physicians and mid-level clinicians.

“This initiative by the region’s health plans is another example of the unprecedented collaboration taking place to enhance healthcare for our community,” Porreca said in the release. “We look forward to managing and executing this program on behalf of the health plans and in turn working with the physician community to make the transition to electronic health records as seamlessly as possible.”

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http://www.buffalonews.com/145/story/718189.html