Welcome to Behavioral Health Software Certification Watch

One of the greatest challenges in behavioral healthcare is keeping up with rapid changes in the industry. Not only are there constant regulatory and reporting changes, health information technology is evolving at a remarkable pace.

To ensure that EHR systems perform at the high level required, more and more providers are looking for certification. Currently, the Certification Commission for Healthcare Information Technology (CCHIT) is the only body that can provide that service. Given its growing role, many are wondering what CCHIT is and how it will affect the behavioral health industry.

That is why Anasazi Software is providing Behavioral Health Software Certification Watch. This page is designed to help behavioral health providers navigate the complex and often confusing area of certification. Anasazi Software will regularly update Certification Watch to ensure you remain informed on the latest developments in this rapidly-changing area.

If you have any questions about Behavioral Health Software Certification Watch or have recommendations about which areas to cover, please contact us at jgabriel@anasazisoftware.com.

Public Comments submitted for CCHIT BH draft criteria
CCHIT Chair to Step Down
Press Release from CCHIT
HIT Policy Committee Reviews Meaningful Use Measures for SpecialistsDrummond Group Issues Press Release Announcing Plans to Certify Electronic Health Records
CCHIT Releases New Certification Programs
CCHIT Announces Comprehensive and Preliminary ARRA Certification PlansWhat is the ONC?
HHS’ ONC HIT Policy Committee Releases Certification Recommendations to HHS
What is CCHIT?
CCHIT Adapting Plans for Certification
How does HL7 relate to CCHIT?
How does CCHIT apply to Behavioral Health?
The Significance of ARRA and HITECH
The Meaning of “Meaningful Use”
CCHIT’s Three Paths of Certification
Significant Dates

Public Comments submitted for CCHIT BH draft criteria (updated Dec. 17, 2009)

The public comment period has ended for the draft criteria of the Certification Commission for Health Information Technology’s (CCHIT) proposed Comprehensive Behavioral Health certification. Vendors and other industry leaders used this opportunity to help shape the upcoming standards for BH software.

The National Council for Community Behavioral Healthcare (NCCBH) published their response on their Web site. In addition to requests for more specificity on certain criteria, the organization mapped the draft measures to meaningful use:

“We believe that the Stand-alone BH Certification should require functionality to meet all of the requirements of ARRA [American Recovery and Reinvestment Act] meaningful use. Our understanding of the proposed process is that it will require two certification steps to demonstrate meaningful use. Once the BH certification is obtained, a vendor will have to certify against the specific modules to fill the gap between the BH certification and the ARRA certification. All other CCHIT certification designations (CCHIT Ambulatory, CCHIT Inpatient, etc.) contain the minimum requirements to demonstrate meaningful use. It breaks precedent to have a CCHIT certification that does not include at least the minimum functionality necessary for meaningful use.”

This concern was echoed by other stakeholders in the BH community. Some vendors noted that minor modifications to the proposed CCHIT criteria could easily accommodate most of the meaningful use components. The goal is to ensure that a provider would not be required to conduct two separate certifications to meet the standards of both CCHIT and ARRA.

The Behavioral Health workgroup of CCHIT is expected to respond to all public comments in February 2010. Certification Watch will keep you up to date on the latest developments.

CCHIT Chair to Step Down (updated Nov.16, 2009)

The Certification Commission for Health Information Technology (CCHIT) has announced that Mark Leavitt, M.D., Ph.D., will retire from his role as the commission's Chair on Mar. 31, 2010. The group's Board of Trustees has initiated a national search for a successor.

CCHIT trustee Frank Trembulak will lead the search committee and a firm has been retained to conduct the search. A press release is available at CCHIT’s Web site.

Criteria for Electronic Health Records Designed for Behavioral Health Services Open for Public Comment (updated Nov. 16, 2009)

Press release from CCHIT:

The Certification Commission for Health Information Technology (CCHIT) Behavioral Health Work Group will make available for public comment the initial draft of criteria for electronic health records (EHRs) designed for behavioral health services at http://www.cchit.org/participate/public-comment. The four-week online comment period begins Nov. 16, 2009, and will close on Dec. 11, 2009.

This initial draft of the criteria is the culmination of 16 months of work for volunteers in CCHIT’s Behavioral Health Work Group who have contributed more than 1,000 hours of their time.  Separate sets of criteria were proposed for two different approaches to EHRs:

• Criteria specific to the needs of behavioral health as an add-on to EHRs for the physician-office, or ambulatory, practice setting.
• A comprehensive stand-alone certification designed uniquely for behavioral health settings and services.

When CCHIT requested public input for additional work groups, a request for behavioral health criteria received one of the largest votes.  Now it is time for the behavioral health community to vote again. 

The 2009 co-chairs, Steven R. Daviss, MD, DFAPA (Chair, Dept of Psychiatry, Baltimore Washington Medical Center), and Sharon Hicks, MSW, MBA (Chief Information Officer, Community Care Behavioral Health Organization of UPMC), urge all stakeholders to come to the CCHIT site and comment on each and every criterion proposed. 

Behavioral health faces some unique challenges, which the behavioral health work group has striven to identify and address.  The public comment period is a great opportunity to have all voices heard: providers, vendors, consumers, advocates, and other stakeholders.

As Dr. Daviss said, “A broad constituency commenting on the proposed criteria will ensure that this first work product of the behavioral health work group will help the behavioral health service delivery system adopt health information technology, use it meaningfully to improve people’s lives, and better integrate behavioral health into the larger physical health system.”

Ms. Hicks reminded commenters to, “Review each criterion in the context of the clinical work or IT needs of your organization or stakeholder group; consider the different needs among the public sector service delivery system and the commercially insured system; and base your comments on your vision of BH service delivery for the near future.“

One of CCHIT’s most successful ideas has proven to be its publication of a forward-looking roadmap of certification requirements, Ms. Hicks added.  By clearly expressing what additional criteria to expect in the future, the roadmap is an effective mechanism for driving enhanced capabilities and standards compliance into the marketplace.  When reviewing criteria, remember that the roadmap designation is your way to indicate that you think that something is important, even if not yet technically feasible.

 “The behavioral health work group includes a broad range of stakeholders and we have discussed each and every one of these criteria,” Dr. Daviss noted.  “We don’t always have 100 percent agreement, but now it is the time for the proponents of behavioral health specific functionality to weigh in with their comments and opinions.  Only by casting a wide net for input will the final product be the accurate representation for which we are all working so hard.”

 HIT Policy Committee Reviews Meaningful Use Measures for Specialists (updated Nov.14, 2009)

The HIT Policy Committee held meetings Oct. 27-28 to review the concept of meaningful use and discuss how it applies to specialties such as behavioral health.

In August of this year, the HIT Policy Committee recommended 26 clinical and quality measures that physicians and hospitals must meet in 2011 to be eligible for funding under the American Recovery and Reinvestment Act (ARRA).

Originally, these measures were designed for primary care providers. In his opening remarks, the National Coordinator for Health Information Technology Dr. David Blumenthal noted that specialties will not be required to meet each of them. “I don’t think it was understood that we weren’t intending to have all the measures apply to all specialists,” he said.

Paul Tang, vice chairman of the Committee and chief medical information officer at the Palo Alto Foundation, echoed Dr. Blumenthal by saying that “not all objectives and measures are appropriate for all eligible professionals.”

Co-Chair of the Meaningful Use Workgroup George Hripcsak stated that the Meaningful Use objectives and measures must be mapped to the eligible professionals to whom they pertain. Hripcsak defined three types:

• “Core measures” are objectives and measures that are relevant to all providers. These include process, quality and efficiency measures.
• “Adult primary care measures” and “pediatric primary care measures” are objectives and measures that are relevant to primary care providers for their respective populations.
• “Specialty measures” are objectives and measures that are defined for specialists, including measures that cross all specialties and specialty-specific measures.

Hripcsak noted that subspecialties are responsible for the objectives and measures of the parent specialty, unless stated otherwise.

It is up to the HIT Policy Committee to decide which of the meaningful use measures should apply to which specialists and when. To help them in their decision, they received testimony from several experts representing various specialties including behavioral health.

One presenter was Dr. Harold Pincus, who serves as Professor and Vice Chair of the Department of Psychiatry at Columbia University, the Director of Quality and Outcomes Research at New York Presbyterian Hospital, and a Senior Scientist at the RAND Corporation. He implored the committee not to “split mind and body” in the health care system.

“Mental illnesses are prevalent, costly and highly co-morbid with other medical conditions,” he stated. However, he also emphasized behavioral health’s uniqueness in structure of care, strained resources, and especially sensitive privacy concerns.

Dr. Pincus recommended that mental health and substance use conditions be fully integrated into the meaningful use framework. “Given the prevalence and societal impact of these conditions and their presence in primary care practices it is hard to justify excluding them any more than excluding diabetes or hypertension,” he said.

“The data capture, decision support, e-prescribing, medication reconciliation, care coordination elements being considered should apply to behavioral health as we try to break down these silos.” Dr. Pincus added that consumer choice and privacy elements must also be integrated.

Hripcsak stated that the Meaningful Use Workgroup will use the information gained from this hearing as it considers future meaningful use criteria.

 Drummond Group Issues Press Release Announcing Plans to Certify Electronic Health Records (updated Nov.14, 2009)

On November 2nd the Drummond Group issued a press release (http://www.drummondgroup.com/html-v2/pr_11_02_09.html) announcing their plans to certify EHRs. In that press release it is stated that “Drummond Group has been approached recently by numerous EHR software and services companies that need to be certified. Clearly there is a growing demand for EHR certifications, says Rik Drummond, CEO of Drummond Group. "Drummond Group has been supporting Fortune 500 industries and government by certifying the transfer, identity and cybersecurity of their internet information flow over the last ten years. We have also done testing for the CDC, DEA and GSA. Certification of EHR is a natural extension of our testing program, and we believe we can provide great value for the medical community. We look forward to the publishing of the ONC requirements in the days ahead so we can get started."

 CCHIT Releases New Certification Programs (updated Oct. 29, 2009)

The Certification Commission for Health Information Technology (CCHIT) released their two 2011 certification programs on Oct. 7, 2009. In addition to an updated Comprehensive EHR certification program, called CCHIT Certified 2011, the Commission is offering a modular certification program called Preliminary ARRA 2011. This second program is limited to the standards for qualifying EHR technology under the American Recovery and Reinvestment Act (ARRA).

CCHIT’s Preliminary ARRA 2011 provides modular certification of EHR technology limited to meeting federal standards for security, privacy and interoperability. This will be the only certification required to qualify for ARRA, and will have far less stringent requirements than CCHIT Certified 2011. Preliminary ARRA 2011 is offered for both Eligible Providers and for Hospitals.

The ARRA component is considered preliminary because the Department of Health and Human Services (HHS) has not yet finalized the definition of meaningful use or established certification criteria or standards. The final definition of meaningful use is expected in spring of 2010. At that time, applicants may need to be retested for any gaps in functionality.

Preliminary ARRA 2011 certification is organized into modules which conform to the 2011 Meaningful Use Objectives as approved by the Health IT Policy Committee. Applicants can select which of the 28 modules they would like to gain certification. Later this month, the Health IT Policy Committee is scheduled to indicate which of these objectives are relevant to other specialties, possibly including behavioral health. Their next full meeting will be held in late October 2009.

CCHIT has identified “gaps” between existing CCHIT criteria and the meaningful use criteria. Some gaps are considered “minor,” such as recording the patient’s preferred language, race and ethnicity using federal Census Bureau guidelines. Other gaps are considered “major,” including “the capability to exchange key clinical information (test results) among providers of care and patient authorized entities electronically.” One module, Reportable Lab Submission, has no approved objectives to test against. All applicants must demonstrate compliance with the Security and Privacy module.

The inspection process involves a combination of documentation review, jury-observed demonstrations and technical testing. CCHIT will post the outcome of “successfully demonstrated modules in a Certification Facts table” on their Web site.

Ultimately, CCHIT certification is expected to be recognized under the ARRA program, but CCHIT makes no “guarantee that they will be so recognized.” No other organizations have currently made any ARRA certification process available.

The comprehensive program, CCHIT Certified 2011, will inspect products “against comprehensive functionality, interoperability, and privacy and security criteria using the Commission’s published methods,” and will “meet or exceed applicable proposed Federal standards for certified EHR technology to support the 2011-2012 incentives under the American Recovery and Reinvestment Act of 2009.”

Currently, there is no comprehensive certification program available for behavioral health products. CCHIT expects to launch two behavioral health certification programs in June 2010. One will be an add-on to the ambulatory health certification program and the other will be for standalone behavioral health systems. According to minutes from the Behavioral Health workgroup, the first draft of the behavioral health criteria should be available this fall.

Both CCHIT 2011 certifications will be effective until Dec. 31, 2012, with the possibility of extension based on HHS directives.

To keep up with all the latest developments, check back with BH Software Certification Watch.

 CCHIT Announces Comprehensive and Preliminary ARRA Certification Plans (updated October 29, 2009)

The Certification Commission for Health Information Technology (CCHIT) held a "Town Call" web conference on Sept. 3, 2009, to gather input and provide an update on the details and timing of its EHR software certification efforts. The organization is responding to the latest recommendations of the HIT Policy Committee on certification and meaningful use.

CCHIT announced that they will offer a modular certification program called CCHIT Preliminary ARRA 2011. This program will be limited to the standards for qualifying EHR technology specifically identified under the American Recovery and Reinvestment Act (ARRA). Also, the organization will proceed with the planned launch of its comprehensive EHR certification program, CCHIT Certified 2011.

CCHIT decided not to delay these certifications because “providers and hospitals who wait until Fall 2010 to choose EHR technology will experience a high risk of failing to achieve meaningful use in time for the 2011-2012 initiatives.”

The Department of Health and Human Services (HHS) is expected to offer their final ruling on Meaningful Use in spring 2010. If they do not introduce more stringent requirements, CCHIT will grant Final ARRA 2011 Certification immediately to those with Preliminary ARRA 2011 Certification. If new requirements are introduced, CCHIT will promptly offer incremental testing to transition those vendors at no additional fee.

As requested by ONC’s HIT Policy Committee, there will be a “level playing field,” meaning a “first come, first served” policy and equal treatment of all vendors whether previously certified or not, CCHIT also offered an in-person certification workshop on Oct. 1, 2009 for vendors and developers.

Although CCHIT has announced that comprehensive certifications for behavioral healthcare will be published in March 2010, it has not yet addressed how CCHIT ARRA certification will be applied to specialties.

To keep up with all the latest developments, check back with BH Software Certification Watch.

 What is the ONC? (Updated September 1, 2009)

As the federal government increases their role in EHR software certification, it is important to learn about the ONC. 

Through a 2004 Executive Order, the President established a new organization within the Department of Health and Human Services (HHS) titled the Office of the National Coordinator for Health Information Technology (ONC). It was created to provide most Americans access to an interoperable electronic medical record by 2014. 

In February 2009, the ONC was mandated legislatively by the Health Information Technology for Economic and Clinical Health Act (HITECH Act), which was part of the American Recovery and Reinvestment Act (ARRA). This legislation raised the ONC's prominence and importance by calling for ONC to help create a secure, interoperable nationwide health information network. 

Two important federal advisory committees within ONC are the HIT Policy Committee and the HIT Standards Committee. ARRA charged these committees with providing recommendations on standards, implementation specifications and certifications criteria. 

To provide recommendations in specific areas, each committee has workgroups. For instance, the HIT Policy Committee has the Meaningful Use Workgroup, Certification and Adoption Workgroup, and Information Exchange Workgroup. 

Each workgroup makes recommendations to the committee, which makes recommendations to ONC and therefore to HHS. As an executive branch agency, HHS answers directly to the President.  

 HHS’ ONC HIT Policy Committee Releases Certification Recommendations to HHS (Updated September 1, 2009)

The HIT Policy Committee held an important meeting August 14, 2009, endorsing recommendations from three important workgroups. These recommendations will now be forwarded to the Office of the National Coordinator for Health Information Technology (ONC) to assist in its healthcare software certification efforts.

The Certification and Adoption Workgroup began their recommendations by defining an “HHS certification”:

HHS Certification means that a system is able to achieve the minimum government requirements for security, privacy and interoperability, and that the system is able to support the achievement of Meaningful Use results that the government expects.

The committee emphasized that the HHS certification is “not intended to be viewed as a ‘seal of approval’ or an indication of the benefits of one system over another.”

The Certification and Adoption Workgroup issued five recommendations:

Focus certification on meaningful use: The National Coordinator should set the criteria for HHS Certification. The criteria should be limited to the minimum required to (a) meet the functional requirements of ARRA, and (b) achieve the Meaningful Use objectives. The focus on Meaningful Use should reduce the barriers currently faced by vendors that focus on specialists (such as the software vendors that are members of SATVA). In addition, the criteria should have explicit requirements for interoperability.

Leverage certification process to improve progress on security, privacy and interoperability: ONC must address all the security and privacy policies described in ARRA while “aggressively” setting new, very specific requirements for interoperability. The workgroup found “limited evidence” that the current process of the Certification Commission for Health Information Technology (CCHIT) had significantly improved interoperability. The recommendation states that “[i]f necessary, ONC should commission (not just harmonize) the development of standards,”

Improve objectivity and transparency of the certification process: ONC needs to separate defining criteria from the actual testing of those criteria. The ONC should work with the National Institute of Standards and Technology (NIST) to develop a comprehensive process for conformity. The office should also develop an accreditation process and select an organization to accredit certifying organizations. This means that multiple organizations should be allowed to perform HHS Certification testing — not just CCHIT. This accreditation “must insure that multiple certification entities use identical criteria and provide a ‘level playing field.’” These changes will make the new HHS Certification process significantly different from the current process in which CCHIT both set the criteria and conducted the testing.

Expand Certification to include a range of software sources: This would help all organizations attain HHS Certification, even if they use software that is open-source, self-developed, or purchased from multiple sources. The recommendation states that “[a]ll EHRs should be certified against the identical certification criteria, regardless of source.”

Develop a short-term certification transition plan: Since the new HHS Certification process will take some time to develop, it was recommended that a “Preliminary HHS Certification” be created to cover the interim. CCHIT was invited by HHS to submit a proposal for providing “Preliminary HHS Certification” that will be offered to vendors by October 2009. Once the regulatory process is completed for Meaningful Use (expected in early 2010), a “Regulatory Gap Certification” would cover any necessary changes from the preliminary certification. In addition, an optional, expedited Regulatory Gap Certification process should be available for vendors who already completed CCHIT 2008 certification, and possibly 2007 certification as well. All these certifications obtained during the transition period should be valid at least through 2011.

The workgroup found the CCHIT process to be transparent and fair, but excessively detailed. “There has been criticism that CCHIT is too closely aligned with HIMSS or with vendors,” the Certification and Adoption Workgroup stated. “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."

While these recommendations open the door to possible competition in the future, CCHIT remains the only EHR certification body currently operational.

In addition to the recommendations provided by the Certification and Adoption Workgroup, the Information Exchange Workgroup made recommendations concerning information exchange requirements, core requirements, certification of interoperability components, aligning federal and state efforts, and bringing existing efforts into alignment. Also, the Meaningful Use Workgroup provided an update on their Meaningful Use Matrix.

Following endorsement by the HIT Policy Committee, each of these recommendations move on toward full approval by HHS. For the latest developments, check back with BH Software Certification Watch.

  What is CCHIT? (Updated October 29, 2009)

 The Certification Commission for Health Information Technology, CCHIT for short, is a private, nonprofit organization dedicated to “accelerating the adoption of robust, interoperable health information technology by creating a credible, efficient certification process.” Since CCHIT is taking a prominent role in the national dialogue about health IT, it is helpful to understand their roots.

On April 28, 2004, President George W. Bush issued Executive Order 13335 calling for widespread adoption of interoperable electronic health records (EHR) within 10 years. In response, CCHIT was founded later that year by three industry associations: the American Health Information Management Association (AHIMA), the Healthcare Information and Management Systems Society (HIMSS), and the National Alliance for Health Information Technology (NAHIT).

Since that time, several medical associations have contributed, and the U.S. Department of Health and Human Services (HHS) granted CCHIT a contract to develop an efficient, credible, and sustainable mechanism for certifying health IT products. In 2006, HHS recognized CCHIT as the only organization to certify Health IT products and systems.

The February 2009 passage of the American Recovery and Reinvestment Act (ARRA) further raised CCHIT’s profile. One section of ARRA — called the Health Information Technology for Economic and Clinical Health (HITECH) Act — provides $2 billion in grants and loans along with a net increase of $20.8 billion in Medicare and Medicaid payments for HIT. While it is reported that Community Behavioral Health Organizations (CBHOs) are eligible for the $2 billion in grants, the $20.8 billion amount does not currently apply to CBHOs. We recommend that providers, states, counties and individuals organize with SATVA and the National Council for Community Behavioral Healthcare (NCCBH) to coordinate outreach to your congressional representatives to request CBHO inclusion in the Medicare and Medicaid funding.

Any EHR software purchased with HITECH funding must be certified. Although CCHIT is not specifically identified as the certification provider, they remain the only body with a track record of certifying EHR software. Because of this, CCHIT is expected to become one of the certification entities.

The HITECH Act also requires that an EHR system meet standards “applicable to the type of record involved” (§ 4101(o)(4)). This probably means that a behavioral health EHR provider will require certification specifically for behavioral health, not for ambulatory or inpatient. Today, it might be advantageous for a vendor to have non-BH CCHIT certification, but it will likely not be sufficient for CBHOs after CCHIT BH certification is available.

Currently, CCHIT only provides comprehensive certification for Ambulatory (with options for Child Health and Cardiovascular Medicine), Inpatient and Emergency EHR systems, none of which are directly applicable to CBHOs. To resolve this issue, CCHIT plans to make a comprehensive Behavioral Health-specific certification process available for the 2011 certification year.

A CCHIT Behavioral Health Work Group met throughout 2008 and a new group began meeting in July 2009 to develop these new standards. It is expected that the Behavioral Health certification will be published in March 2010. Currently, the plan is to allow comprehensive Behavioral Health certification in two different ways: as a standalone comprehensive Behavioral Health certification and as an “add-on” certification for Ambulatory Health. CCHIT has not yet addressed how their ARRA certification will be applied to specialties.

Applications for certification re-opened on Oct. 7, 2009 for the comprehensive CCHIT Certified 2011 certification and a Preliminary ARRA 2011 certification. The Preliminary ARRA 2011 will be limited to the standards for qualifying EHR technology specifically identified under the ARRA. This will be the only certification required to qualify for ARRA, and will have far less stringent requirements than the comprehensive certification.

Being a more general offering that their comprehensive products, CCHIT’s Preliminary ARRA 2011 certification is organized into 28 modules which conform to the 2011 Meaningful Use Objectives as approved by the ONC’s Health IT Policy Committee. In the third quarter of 2009, the Health IT Policy Committee plans to indicate which of these modules are relevant to behavioral health and other specialties. Comprehensive certification is based upon a scenario-based test and 100 percent compliance is required. For example, the 2011 comprehensive Ambulatory certification requires an EHR to correctly handle three scenarios:

• A routine well-child visit to a Primary Care Physician.
• A routine maternity visit to an Obstetrician for a pregnant woman who has been diagnosed with Gestational Diabetes.
• A preventive care visit for a male veteran with multiple chronic medical problems.

CCHIT’s comprehensive Behavioral Health certification will include different test scenarios that will specifically relate to behavioral health. Three paths to certification will be provided, including Comprehensive (EHR-C), Modular (EHR-M) and Site/Organization (EHR-S). These are discussed in greater detail in the “CCHIT’s three paths of certification” section. As mentioned above, it remains to be seen how CCHIT will handle their ARRA certification for specialties.

Be sure to check back with Certification Watch for the latest developments.

CCHIT Adapting Plans for Certification (Updated October 29, 2009)

On Sept. 3, 2009, CCHIT held a "Town Call" web conference to gather input on the details and timing of its EHR software certification efforts. The organization is responding to the latest recommendations of the HIT Policy Committee on certification and meaningful use.

“CCHIT has analyzed the recommendations of the Federal HIT Advisory Committees and is preparing to offer new paths to certification beginning this October," said Mark Leavitt, M.D., Ph.D., CCHIT chair. The organization plans to launch a more limited, modular inspection program for EHR technology, focusing only on compliance with ARRA-required standards.

The HIT Policy Committee recommended the creation of a single HHS certification addressing all specialties. They invited CCHIT to submit a proposal for providing “Preliminary HHS Certification” by Sept. 15, 2009. Following approval by ONC, the Preliminary HHS Certification was made available to vendors on Oct. 7, 2009.

Once the regulatory process is completed for Meaningful Use (expected in early 2010), a “Regulatory Gap Certification” would cover any necessary changes from the Preliminary HHS Certification. The HIT Policy Committee also recommended an optional, expedited Regulatory Gap Certification process for vendors that already completed CCHIT 2008 certification.

All these certifications obtained during this transition period are expected to be valid through 2012.

Please follow Certification Watch for the most recent CCHIT information.

How does HL7 relate to CCHIT? (Updated August 19, 2009)

As CCHIT creates their Behavioral Health certification, they will likely rely heavily on the pioneering work done by Health Level Seven. HL7 is a healthcare informatics standards development organization accredited by the American National Standards Institute (ANSI). It develops, disseminates and provides training for a broad range of health informatics standards including messaging, document architecture, vocabulary, and functionality.

The chair of CCHIT, Mark Leavitt, MD, PhD, has often recognized the value of HL7’s work. “The HL7 standard for EHR systems has been extremely valuable to us, providing the starting framework for CCHIT's development of certification criteria,” he said.

In early 2007, the Substance Abuse and Mental Health Services Administration (SAMHSA) convened a Behavioral Health Standards (BHS) Workgroup comprised of experts representing major stakeholders such as providers, vendors, as well as state, local and federal behavioral health organizations. The BHS workgroup developed a behavioral health conformance certification profile, based on the HL7 EHR Functional Model.

Reviewing administrative, infrastructure and clinical requirements, they determined whether specific functions were needed across all behavioral health settings or just subsets (i.e., inpatient facilities). This workgroup also reviewed whether the functions were realistic at the moment or whether new standards or technologies would be required prior to implementation. The resulting profile was submitted to HL7 for review.

In September 2007, HL7 released a Functional Profile for behavioral health EHRs that reflected the work of this workgroup. The profile provides a list of required functions along with conformance criteria specific to the industry. SATVA members served on this HL7 work group, taking an active role in the creation of these important standards.

How does CCHIT apply to Behavioral Health? (Updated November 14, 2009)

 CCHIT currently offers EHR certification in three categories: Ambulatory, Inpatient and Emergency Department. Since these categories use test scenarios focusing on medical care, SATVA saw a need for an EHR certification specifically created for the unique requirements of Behavioral Health.

Due in part to SATVA’s and SAMHSA’s leadership, Behavioral Health was one of the first specialized workgroups established by CCHIT. Several SATVA members served on CCHIT’s 2008 Behavioral Health Work Group as well as on the 2009 group. As of July 2009, there are 265 members serving on 19 work groups, including Behavioral Health, Clinical Research, Cardiovascular Medicine, Child Health, Dermatology and Long-Term Care.

According to CCHIT, the goal for the workgroups is to “take on the challenge of rapidly transitioning the Commission’s existing certification programs, and developing new paths to certification, to directly satisfy the objectives and measures of meaningful use, to be released soon by the Office of the National Coordinator (ONC) and its Advisory Committees.”

On Oct. 7, 2009, CCHIT opened applications for a Preliminary ARRA 2011 certification. The Preliminary ARRA 2011 is limited to the standards for qualifying EHR technology specifically identified under the ARRA. This will be the only certification required to qualify for ARRA, and will have far less stringent requirements than the comprehensive certification.

Being a more general offering that their comprehensive products, CCHIT’s Preliminary ARRA 2011 certification is organized into 26 modules which conform to the 2011 Meaningful Use Objectives as approved by the ONC’s Health IT Policy Committee. In late 2009, the Health IT Policy Committee plans to indicate which of these modules are relevant to specialties, possibly including behavioral health.

 The Significance of ARRA and HITECH (Updated August 19, 2009)

 The Health Information Technology (HITECH) Act, contained within the American Recovery and Reinvestment Act (ARRA), provides $2 billion in grants and loans as well as a net increase of $20.8 billion in Medicare and Medicaid payments for Health Information Technology (HIT). (Please note that the $20.8 billion total applies to single practitioner psychiatrists but not currently to CBHOs. We strongly recommend that providers coordinate outreach with NCCBH for CBHO inclusion.)

EHR software purchased with these funds must meet several requirements:

Certified: While not specifically mentioned, one certification option is generally expected to come through CCHIT. It is expected that the Behavioral Health Certification will be published in March 2010.

Treatment-specific: The HITECH Act requires that an EHR meet standards “applicable to the type of record involved.” This likely means that a Behavioral Health EHR system will require certification specifically for Behavioral Health rather than for Ambulatory, Inpatient, etc.

Interoperable: The HITECH Act requires that an EHR system be interoperable and promote the “interoperability of clinical data repositories or registries.” The CCHIT 2008 Ambulatory Certification required testing for interoperability of EHRs by ensuring software is compatible with “Continuity of Care Documents (CCDs) formatted to the HITSP/C32 specifications”, for the receipt of laboratory results, and to either have certification from or demonstrate e-prescribing functionality comparable to Surescripts certified e-prescribing software. CCHIT requires the interoperability of CCDs for HIEs and in the draft tests for PHRs. This indicates that CCD interoperability is a goal of the HITECH Act.

Meaningful Use: To receive the HITECH Act’s Medicare and Medicaid incentive payments, EHR technology must be utilized in “meaningful use” by physicians during the year of reimbursement. This means that the software must be fully implemented to receive the increased Medicare and Medicaid payments. The reimbursements are also specifically on a per Physician per year basis. The precise definition of “meaningful use” is still to be developed by HHS. HHS’ HIT Policy Committee released recommendations on defining “meaningful use” in July 2009. The final definition is expected by the end of 2009.

E-prescribing: An important goal of the HITECH Act is to promote the use of electronic prescribing. The language mandates that EHR technology “shall include the use of electronic prescribing.”

To ensure that behavioral health issues are kept on the front burner in Washington, D.C., the National Council for Community Behavioral Healthcare (NCCBH) held a successful “Hill Day” in June. The event had 380 NCCBH members advocating for the cause. The National Council also sponsored a national call-in day in which members phoned elected officials on Capitol Hill.

If CBHOs are made eligible for the ARRA Medicare and Medicaid incentives, providers will need their EHR software purchased, installed and operating in accordance with federal criteria by 2011 to realize maximum benefit.

Stay tuned to Certification Watch for continuing developments.

 The Meaning of “Meaningful Use” (updated September 1, 2009)

 The Office of the National Coordinator for Health Information Technologies (ONC), recently released for comment their recommendations about the definition of “meaningful use” as it applies to health IT. The American Recovery and Reinvestment Act (ARRA) authorizes the Centers for Medicare & Medicaid Services (CMS) to provide a reimbursement incentive for physician and hospital providers who are successful in becoming “meaningful users” of electronic health records (EHR).

The Department of Health and Human Services (HHS) has begun the process of defining “meaningful use” of electronic health records (EHRs). In June 2009, HHS’s Office of the National Coordinator for Health Information Technologies (ONC) issued a “meaningful use matrix” and received comments about their recommendations from interested parties. After reviewing the comments, a revised meaningful use matrix was released in July 2009.

On August 14, 2009, the HIT Policy Committee adopted recommendations from their Meaningful Use Workgroup which revised the meaningful use matrix and provided a rough timeline for the next year. In the third quarter of 2009, the workgroup plans to develop a process for updating meaningful use objectives and measures and to tag 2011 measures that are relevant to specialties such as behavioral healthcare.

The matrix defined specific, measurable objectives for meaningful use. While any use of EHR software is important, providers must ensure they are using the software in a meaningful way to ensure incentive payments. As drafted, the current meaningful use matrix does not fully align with the behavioral health practices and programs. Since the final “meaningful use” definition is not due until the end of 2009, it would be helpful for organizations and providers to publish and promote their concerns.

“Meaningful use” is an important term to define for the coming years. To receive incentive payments sanctioned by ARRA, providers must demonstrate “meaningful use” of a certified EHR. “The definition will inform everything that we (ONC) do that is related to health IT, including product certification, funding and technical support,” said National Coordinator for Health Information Technology David Blumenthal, M.D., M.P.P.

Several interested parties have responded to the recommendations, including NCCBH and CCHIT. In their statement, NCCBH stressed the importance of including behavioral health and substance use treatment providers in the definitions of “meaningful user.” Meanwhile, CCHIT offered an annotated matrix showing how close their current standards are to those proposed by HHS. The CCHIT response said that “most of the measures proposed for 2011 would be difficult to achieve by providers who have not already begun EHR implementations.” This is due to the time between the decision to purchase an EHR and its full implementation.

Building upon the ONC recommendations, the Centers for Medicare & Medicaid Services (CMS) will develop a proposed rule that proposes a definition of meaningful use. CMS expects to issue the proposed rule by the end of 2009, which will be followed by a comment period.

CCHIT’s Three Paths of Certification (updated October 29, 2009)

 In June 2009, CCHIT announced that they will broaden the access to certification, including the new BH certification, by offering three paths instead of just one. The group thought this change was necessary to maximize the impact of the significant incentives provided by ARRA and the HITECH Act. The three paths are outlined accordingly:

• EHR-C: A rigorous certification for comprehensive EHR systems that enable providers to meet all meaningful use objectives. Products must significantly exceed minimum Federal standards requirements, are rated for usability, and are verified to be in successful use at multiple sites. This program addresses the needs of providers and hospitals who want maximal assurance of EHR capabilities and compliance. For the BH industry, there are expected to be two types of EHR-C certifications available:
  • The standalone BH Comprehensive certification
  • An Ambulatory certification with a BH “add-on”
• EHR-M: A modular certification program for applications that address one or more of the meaningful use objectives. Products must meet minimum Federal standards requirements. This program allows providers and hospitals to combine technologies from multiple certified sources.
• EHR-S: A simplified, low cost certification for sites or organizations. Technology must meet minimum Federal standards requirements. This program allows providers and hospitals who develop or assemble EHR technologies themselves to qualify for ARRA incentives, offering an open door to encourage continued innovation.

It is expected that a BH provider will need to use an EHR-C certified solution (via the BH Comprehensive or Ambulatory BH “add-on”) or complete their own EHR-S certification.

“The rate of EHR adoption must now be tripled to meet the ambitious ARRA timelines, so we’re broadening access to certification, widening our previous single-lane road to the equivalent of a three-lane freeway,” said Mark Leavitt, M.D., Ph.D., CCHIT chair. “We need to serve a more diverse spectrum of providers and offer a wider range of EHR technology options from which to choose.”

This new structure will be beneficial to providers using several vendors and to vendors that wish to integrate their software with third parties.

With the old, single-path certification, software needed to be re-certified every three years for the 2006 and 2007 certification and every two years starting with the 2008 certification. And when a product was enhanced, you couldn’t presume that the certification was still valid. With the three-path system, it appears that once a software package is approved by CCHIT, any new version of the software will inherit the certification without need for additional approval. While all of the specifics are still being developed, it appears that products certified in prior years may have to be recertified by 2011 using this new system and then every two years after that. CCHIT maintains a list of current vendors certified for ambulatory care. The 2006 certification term expires in 2009 or 2010 and the 2007 and 2008 terms expire in 2010 and 2011.

This three-tier program has significantly changed CCHIT’s 2009 and 2010 certification plans. Instead of launching 2009 certification programs, CCHIT has submitted that criteria to the HIT Standards Committee for review. CCHIT explains the new roadmap on their Web site:

Many vendors have asked whether they should be developing to our 2009 criteria and test scripts, or waiting for our 2011 ARRA version. Just to be clear, there will not be a 2009 certification program. Our next launch — this Fall — will be for a 2011 ARRA certification. The correlation between our 2009 criteria, including the roadmap, and our 2011 ARRA criteria will depend on decisions yet to be made by ONC and the two advisory committees.

CCHIT has announced that a Behavioral Health-specific certification will be available in July 2010 for the 2011 certification year. This certification will have a term of two years. CCHIT is preparing an all-new “Certification Handbook” to reflect these myriad changes. It will be released in fall 2009. As always, keep checking Certification Watch to keep up-to-date with the latest certification developments.

Significant Dates

December 31, 2009	CMS deadline to issue proposed rule that proposes a definition of meaningful use. Will be followed by a comment period.
February 2010	CCHIT BH Workgroup expected to release responses to public comment on draft BH Certification criteria.
Early 2010	Final Meaningful Use definition released. Regulatory Gap Certification and 2008 Gap Certification criteria available to vendors.
March 2010	CCHIT expected to release certification criteria for Behavioral Health-specific certification.
June 2010	CCHIT expected to open applications for Behavioral Health-specific certification.