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The ONC's Temporary Certification Program

The Office of the National Coordinator for Health Information Technology (ONC) has established a temporary certification program for health information technology (health IT). The program provides a way for organizations to become authorized by the National Coordinator to test and certify electronic health record (EHR) technology.

Certification assures health care providers that the EHR technology they adopt includes the capabilities they will need to participate in the Medicare and Medicaid EHR incentive programs.

Use of certified EHR technology is a core requirement for health care providers to become “meaningful users” and eligible for payment under Medicare and Medicaid EHR incentive programs.

To become an ONC-Authorized Testing and Certification Body (ONC-ATCB), an organization must submit an application to ONC to demonstrate its competency and ability to test and certify Complete EHRs and/or EHR Modules.

Applicants are required to request, in writing, an application for ONC-ATCB status from the National Coordinator at ATCBapplication@hhs.gov. The application has two parts:

• Part I: Provide general identifying and contact information; complete and submit the results of self-audits to all sections of ISO/IEC Guide 65:1996 (Guide 65) and ISO/IEC 17025:2005 (ISO 17025); submit additional documentation related to Guide 65 and ISO 17025; and agree to adhere to the Principles of Proper Conduct for ONC-ATCBs.

• Part II: Successfully complete a proficiency examination.

Applicants are required to complete and submit both parts of the application to the National Coordinator for the application to be considered complete. Please review Section III of the final rule for more details about the application and application review processes.

Temporary Certification Program—final rule

Click on Temporary Certification Final Rule to access the ONC's "Establishment of the Temporary Certification Program for Health Information Technology; Final Rule" document published June 24, 2010, in The Federal Register. This final rule establishes a temporary certification program for the purposes of testing and certifying health information technology. The National Coordinator will utilize the temporary certification program to authorize organizations to test and certify complete EHRs and/or EHR Modules, thereby making Certified EHR Technology available prior to the date on which healthcare providers seeking incentive payments available under the CMS EHR Incentive Programs may begin demonstrating meaningful use of Certified EHR Technology.

ONC Temporary Certification Fact Sheet

The Health Information Technology for Economic and Clinical Health (HITECH) Act provides HHS with the authority to establish programs to improve health care quality, safety, and efficiency through the promotion of health information technology (HIT), including electronic health records (EHRs) and private and secure electronic health information exchange.

The HITECH legislation directs the Office of the National Coordinator for Health Information Technology (ONC) to support and promote meaningful use of certified electronic health record (EHR) technology nationwide through the adoption of standards, implementation specifications, and certification criteria as well as the establishment of certification programs for HIT, such as EHR technology.

About the Temporary Certification Program and ONC-ATCBs

To provide assurance to eligible professionals, eligible hospitals and critical access hospitals (CAHs) that the EHR technology they adopt will assist their achievement of meaningful use, the Department of Health and Human Services (HHS) issued a final rule to establish a temporary certification program for EHR technology on June 18, 2010. The rule outlines how organizations can become ONC-Authorized Testing and Certification Bodies (ONC-ATCBs). Authorized by the National Coordinator, ONC-ATCBs are required to test and certify that certain types of EHR technology (Complete EHRs and EHR Modules) are compliant with the standards, implementation specifications, and certification criteria adopted by the HHS Secretary and meet the definition of “certified EHR technology”.

About the Standards, Implementation Specifications, and Certification Criteria

On January 13, 2010, the Secretary published in the Federal Register an interim final rule that adopted standards, implementation specifications, and certification criteria for HIT. A final rule, which will realign with the Medicare and Medicaid EHR Incentive Programs final rule, is expected to be released in the near future.

What Certification Means for Health Care Providers

EHR technology, certified by an ONC-ATCB must be used in order to qualify for incentive payments. The temporary certification program provides assurance that the EHR technology health care providers adopt is technically capable of supporting their efforts to achieve meaningful use.

What Certification Means for Developers of EHR Technology

The temporary certification program provides a way for developers of EHR technology to have their HIT tested and certified so that it can be subsequently adopted by eligible professionals, eligible hospitals and CAHs who seek to achieve meaningful use.

For other questions related to the Temporary Certification program, please email ONC.Certification@hhs.gov.

• Temporary Certification Program, visit http://healthit.hhs.gov/certification
  
• Medicare and Medicaid EHR incentive programs, visit http://www.cms.gov/EHRIncentivePrograms/
  

Temporary Certification Program Final Rule: FAQs

A.    Background/General

Key Messages

Health Care Providers: Key Points

In order to qualify for Medicare and Medicaid EHR incentive payments, providers must use EHR technology that has been certified by an Office of the National Coordinator for Health Information Technology-Authorized Testing and Certification Body (ONC-ATCB, or ATCB). The temporary certification program provides assurances that the EHR technology adopted by health care providers is technically capable of supporting their efforts to achieve meaningful use.

Developers of EHR Technology: Key Points

The temporary certification program provides a way for developers of EHR Technology to have their EHR technology tested and certified so that it can be subsequently adopted by health care providers who seek to achieve meaningful use.

A1. What is the temporary certification program final rule?

The Secretary of Health and Human Services (the Secretary) issued the temporary certification program final rule to establish a process through which organizations may become ONC-ATCBs. An ONC-ATCB is authorized by the National Coordinator to test and certify EHR technology (Complete EHRs and/or EHR Modules).

A2. What is the purpose of the temporary certification program?

The temporary certification program is the first part of ONC’s two-part approach to establish a transparent and objective certification process. The temporary certification program was established to ensure that “Certified EHR Technology” will be available for adoption by health care providers who seek to qualify for the Medicare and Medicaid EHR incentive payments beginning in 2011. ONC-ATCBs will be required to test and certify EHR technology (Complete EHRs and/or EHR Modules) as being in compliance with the standards, implementation specifications, and certification criteria to be adopted by the Secretary in a forthcoming final rule.

A3. When will the temporary certification program end?

The temporary certification program will be in effect until the permanent certification program is in place. We anticipate that certifications issued under the permanent certification program will occur no earlier than January 1, 2012.

A4. How will ONC work with the National Institute of Standards and Technology (NIST) in regard to certification and standards?

ONC will work with NIST to ensure the availability of relevant test methods and other resources for the temporary certification program.  ONC will continue to work with NIST in developing the permanent certification program.

B. Application Process

B1. How does an organization become an ONC-ATCB?

An organization must submit an application to the National Coordinator to demonstrate its competency and ability to test and certify EHR technology (Complete EHRs and/or EHR Modules). Once authorized, ONC-ATCBs are required to comply with the principles and conditions applicable to the testing and certification of EHR technology as specified in the temporary certification program final rule.

B2. Can you provide an overview of the application process?

Applicants are required to request, in writing, an application for ONC-ATCB status from the National Coordinator at ATCBapplication@hhs.gov. The application has two parts:

• Part I: Provide general identifying and contact information; complete and submit the results of self-audits to all sections of ISO/IEC Guide 65:1996 (Guide 65) and ISO/IEC 17025:2005 (ISO 17025); submit additional documentation related to Guide 65 and ISO 17025; and agree to adhere to the Principles of Proper Conduct for ONC-ATCBs.
• Part II: Successfully complete a proficiency examination.

Applicants are required to complete and submit both parts of the application to the National Coordinator for the application to be considered complete. Please review Section III of the final rule for more details about the application and application review processes.

B3. When will ONC begin accepting applications, and when will applicants be informed if they have received ONC-ATCB status?

The National Coordinator will begin accepting applications on July 1st and any time thereafter while the temporary certification program is operating.  Because the final rule is effective immediately, the National Coordinator will review, process, and make determinations regarding submitted applications as soon as possible.

B4. Will ONC limit the number applicants who apply for ONC-ATCB status?

ONC will not restrict the number of applicants who may apply for ONC-ATCB status. Having available more organizations with ONC-ATCB status will give developers of EHR technology more options for testing and certification. 

C. Certification Process

C1. I have an EHR technology ready for market. Is there anything I can do to get the technology certified now so that I can start marketing to hospitals and physicians?

Until organizations are authorized by the National Coordinator to perform testing and certification, EHR technology cannot be tested and certified in accordance with the temporary certification program final rule.  At this time, no organizations are currently authorized to test and certify EHR technology under the temporary certification program established by HHS, but when organizations attain ONC-ATCB status ONC will make it publicly known and post their names on our website.  ONC will work with ATCBs to encourage them to begin certifying EHR technology as soon as possible after they are authorized to do so.

C2. When will ONC-ATCBs be up and running?

ONC-ATCBs are permitted to start testing and certifying EHR technology consistent with the scope of their authorization as soon as it is received. Some ONC-ATCBs may need more time to establish their processes than others; however, we anticipate that ONC-ATCBs would be ready to test and certify EHR technology within a few weeks of attaining their authorization.
   
C3. How long will it take for an EHR technology to be certified?

This will vary according to the process used by the ONC-ATCB.

C4. What does a developer of EHR technology need to do to get its EHR technology tested and certified?

A developer of EHR technology will need to (1) select an ONC-ATCB that is authorized to test and certify its EHR technology (Complete EHR or EHR Module), and (2) demonstrate in accordance with the ONC-ATCB’s processes that the EHR technology provides the capabilities required by all applicable certification criteria adopted by the Secretary.

C5. Where can I find out information about EHR technology that has been certified?

ONC will maintain on its website a Certified HIT Products List (CHPL) as a single, aggregate source of all certified Complete EHRs and EHR Modules reported by ONC-ATCBs to the National Coordinator.  The CHPL will comprise all of the certified Complete EHRs and EHR Modules that could be used to meet the definition of Certified EHR Technology.  It will also include the other pertinent information we require ONC-ATCBs to report to the National Coordinator, such as a certified Complete EHR’s version number.  Eligible professionals and eligible hospitals that elect to use a combination of certified EHR Modules may also use the CHPL webpage to validate whether the EHR Modules they have selected satisfy all of the applicable certification criteria that are necessary to meet the definition of Certified EHR Technology. 

C6. Will EHR technology previously certified under any other programs or organizations automatically be certified by this new process?

No. In order to meet regulatory requirements implementing the HITECH Act, including the definition of “Certified EHR Technology,” EHR technology (Complete EHRs and/or EHR Modules) must be tested and certified by an ONC-ATCB. Any other certifications issued by an organization that is not an ONC-ATCB at the time of issuance will be invalid for purposes of meeting the definition of Certified EHR Technology and cannot be used to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs. Unless reissued in accordance with the requirements of the temporary certification program, certifications previously issued by an organization that has subsequently become an ONC-ATCB will also be invalid for purposes of satisfying the definition of “Certified EHR Technology,” because such certifications were issued prior to the organization achieving ONC-ATCB status.

Certification by an ONC-ATCB means that EHR technology meets the specific standards, implementation specifications, and certification criteria established for the temporary certification program. (HHS issued an interim final rule outlining specific standards and certification criteria on December 30, 2009, and a final rule is expected to be issued in the near future.)

EHR technology must be tested and certified by an organization authorized by ONC as an ONC-ATCB, using currently adopted standards and certification criteria. Once ONC has authorized testing and certification organizations as ONC-ATCBs, the follow actions are appropriate:

• Developers of EHR technology who wish to have their EHR technology tested and certified should contact an ONC-ATCB
• Health care providers who are eligible under the Medicare and Medicaid EHR Incentive Programs should contact their vendors to ensure their EHR technology is tested and certified by an ONC-ATCB under the temporary certification program requirements

C7. Will EHR technology certified under the temporary certification program be automatically certified under the permanent certification program?

EHR technology tested and certified by an ONC-ATCB under the temporary certification program will remain certified once the permanent certification program replaces the temporary certification program.  The change in certification programs will not affect the certified status of EHR technology at the time of change.  However, we anticipate that new or modified certification criteria will be adopted by the Secretary to support future stages of meaningful use, and as a result, certifications issued by ONC-ATCBs will presumably no longer indicate or represent that a Complete EHR or EHR Module can provide all of the capabilities necessary for an eligible professional or eligible hospital to achieve a future stage of meaningful use.

C8. Whose responsibility is it to make sure that EHR technology gets tested and certified as required to meet the certification criteria adopted to support meaningful use?

In most cases it will be the responsibility of developers of EHR technology that sell EHR technology.  However, a health care provider that has developed its own EHR technology and is eligible under Medicare and Medicaid EHR Incentive Programs likely will be responsible for getting it tested and certified.

C9. If I buy an EHR technology that is tested and certified, does that qualify me for the Medicare or Medicaid EHR incentive payments?

Having EHR technology that is certified by an ONC-ATCB is an essential part of qualifying for the EHR incentive payments. For details on the Medicare and Medicaid EHR Incentive Programs, please visit http://www.cms.gov/Recovery/11_HealthIT.asp.

C10. I already use EHR technology. If it gets certified, will I qualify for the Medicare or Medicaid EHR incentive payments?

If the EHR technology you currently use is certified in the HHS temporary certification program, you may be eligible for incentive payments. For details on the Medicare and Medicaid EHR Incentive Programs, please visit http://www.cms.gov/Recovery/11_HealthIT.asp.

D. Comments on Proposed Rule

D1. Where can I learn about how my comments on the proposed rule on the Establishment of Certification Programs for Health Information Technology issued in March were addressed in the temporary certification program final rule?

ONC staff carefully reviewed and considered each comment received on the proposed rule. Section III of the temporary certification program final rule includes a discussion of how the comments were incorporated into the temporary certification program final rule.

E. Related Rules

E1. How does this final rule relate to the Medicare and Medicaid EHR Incentive Programs Proposed Rule?

The National Coordinator will use the temporary certification program to authorize organizations to test and certify EHR technology (Complete EHRs and/or EHR Modules). Once tested and certified, these types of HIT may be used to meet the regulatory definition of “Certified EHR Technology.” Health care providers who are eligible to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required to use Certified EHR Technology, as promulgated in the CMS final rule.
HHS expects to issue final rules related to the initial set of standards, implementation specifications, and certification criteria and to the Medicare and Medicaid EHR Incentive Programs in the near future.

E2. When will the permanent certification program final rule be published?

We anticipate that a final rule for the permanent certification program will be issued by fall 2010 and that the permanent program will be in place in 2012.

For other questions related to the Temporary Certification program, please email ONC.Certification@hhs.gov.

Centers for Medicare and Medicaid Services Meaningful Use Notice of Proposed Rulemaking

Overview

The American Recovery and Reinvestment Act of 2009 (Recovery Act) authorizes the Centers for Medicare & Medicaid Services (CMS) to provide reimbursement incentives for eligible professionals and hospitals who are successful in becoming “meaningful users” of certified electronic health record (EHR) technology.  The Medicare EHR incentive program will provide incentive payments to eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) that are meaningful users of certified EHR technology. The Medicaid EHR incentive program will provide incentive payments to eligible professionals and hospitals for efforts to adopt, implement, or upgrade certified EHR technology or for meaningful use in the first year of their participation in the program and for demonstrating meaningful use during each of five subsequent years.

Rule Development

On December 30, 2009, CMS announced a notice of proposed rulemaking (NPRM) to implement provisions of the Recovery Act that provide incentive payments for the meaningful use of certified EHR technology.  The proposed rule outlines provisions governing the EHR incentive programs, including defining the central concept of “meaningful use” of EHR technology.  CMS’ goal is for the definition of meaningful use to be consistent with applicable provisions of Medicare and Medicaid law while continually advancing the contributions certified EHR technology can make to improving health care quality, efficiency, and patient safety. To accomplish this, CMS’ proposed rule would phase in more robust criteria for demonstrating meaningful use in three stages. CMS provided a 60-day comment period on the proposed rule, which concluded on March 15, 2010.

In a related announcement, ONC has issued an Interim Final Rule (IFR) [PDF - 247 KB] that specifies the Secretary’s adoption of an initial set of standards, implementation specifications, and certification criteria for electronic health record (EHR) technology.

Learn more about the NPRM

• Meaningful Use Notice of Proposed Rulemaking (NPRM) [PDF - 7.38 MB]
  
• Public comment period closed.
• CMS Fact Sheets:
• Meaningful Use
  
• Medicaid Incentive Program
  
• Medicare Incentive Program
  
• CMS Meaningful Use Frequently Asked Questions
  
• View the CMS press release  

Health Information Technology Policy & Standards Committees Work

Both the HIT Policy Committee and the HIT Standards Committee provided recommendations to the National Coordinator for Health Information that will help CMS develop the initial criteria for meaningful use and assist in planning for any criteria expansion for the future incentive programs. More than 800 public comments were received on the HIT Policy Committee’s initial recommendations.
In addition, helpful input was provided at the April 28-29, 2009, hearing of the National Committee on Vital and Health Statistics and at 21 listening sessions that CMS conducted in June.

Other Meaningful Use Documents

Other Meaningful Use documents from ONC, CMS, NCVHS, and the HIT Standards and Policy Committees.

Standards and Certification Criteria Interim Final Rule

Providers and patients must be confident that the electronic health information technology (health IT) products and systems they use are secure, can maintain data confidentiality, can work with other systems to share information, and can perform a set of well-defined functions. To this end, an Interim Final Rule (IFR) on an initial set of standards, implementation specifications, and certification criteria for adoption by the HHS Secretary was issued on December 30, 2009, with a request for comments.  This Interim Final Rule represents the first step in an incremental approach to adopting standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health IT and to support its meaningful use. The certification criteria adopted in this initial set establish the required capabilities and related standards that certified electronic health record (EHR) technology will need to include in order to, at a minimum, support the achievement of the proposed meaningful use Stage 1 (beginning in 2011) by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR incentive programs.

Learn more about the IFR

• Standards & Certification Interim Final Rule: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology [PDF - 247 KB]
  
• Public Comment period closed on March 15, 2010.
• Standards & Certification IFR Facts-at-a-Glance [PDF - 371 KB]
  
• Standards & Certification IFR Frequently Asked Questions
  

Update on Meaningful Use

In a related announcement, the Centers for Medicare & Medicaid Services (CMS) also issued a Notice of Proposed Rulemaking (NPRM) [PDF - 7.38 MB] on the definition of “meaningful use.” In order for professionals and hospitals to be eligible to receive payments under the Medicare and Medicaid EHR incentive programs they must be able to demonstrate meaningful use of a certified EHR system. The proposed standards and certification criteria in the IFR are fundamentally linked to and specifically designed to support the 2011 meaningful use criteria.

For other questions relating to the Temporary Certification Program, email ONC.Certification@hhs.gov.