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 and Vendors 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-Authorized Testing and Certification Bodies (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 adopted by the Secretary on July 13, 2010.

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 summer 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.

B1. How does an organization become an ONC-Authorized Testing and Certification Body (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 began accepting applications on July 1, 2010. ONC will continue to accept applications 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.

B5. Can my organization apply to become an ONC-ATCB?

The National Coordinator will accept applications while the Temporary Certification Program is operating. The National Coordinator will continue to review, process, and make determinations regarding submitted applications as soon as possible. Organizations interested in becoming an ONC-ATCB must request, in writing, an application to ATCBapplication@hhs.gov. The request must include the name of the organization, the name and email address for a point of contact, and the scope of authorization sought.

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?

Developers of EHR technology should contact an ONC-ATCB to have their technology tested and certified. ONC is working with the ONC-ATCBs to enable them to begin certifying EHR technology as soon as possible. ONC will provide updates as organizations attain ONC-ATCB status to test and certify EHR Modules.

C2. Where can I find the list of ONC Authorized Testing and Certification Bodies (ONC-ATCBs)?

The list of ONC Authorized Testing and Certification Bodies (ONC-ATCBs) is available on the ONC website.

C3. 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.

C4. How long will it take for an EHR technology to be certified? How soon will ONC-ATCB certified EHR be announced?

This will vary according to the process used by the ONC-ATCB and on the EHR product or module being tested. ONC-ATCBs will report to the National Coordinator information about all certified EHR technology. ONC will maintain on its website a list of certified EHR technology as reported by the ONC-ATCBs.

C5. 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.

C6. What criteria will ONC-ATCBs use to test and certify EHR technology?

ONC-ATCBs are required to use ONC-approved test procedures to test and certify EHR technology against the standards, implementation specifications, and certification criteria adopted by the Secretary.

C7. How much will ONC-ATCBs charge for testing and certifying my EHR technology? Does ONC control the cost of certifying or suggest a pricing schedule for the ATCBs?

The ONC-ATCBs will individually and independently determine their pricing structure for the testing and certification of EHR technology. They should be contacted directly for this specific information.

ONC does not control the prices charged by the ONC-ATCBs to test and certify EHR technology.

C8. How can developers of EHR technology prove that their products have been tested and certified by an ONC-ATCB? Will we receive a "seal of approval" or "certificate"?

Each tested and certified EHR product will receive a unique certification number from the ONC-ATCB. In addition, certified EHR technology will be listed on the Certified Health IT Product List (CHPL) on the ONC website.

C9. Where can I find out information about EHR technology that has been certified?

ONC will maintain on its website a Certified HIT Product 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.

C10. 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. A final rule on an initial set of standards, implementation specifications, and certification criteria for adoption by the HHS Secretary was issued on July 13, 2010.)

EHR technology must be tested and certified by an organization authorized by ONC as an ONC-ATCB, using currently adopted standards and certification criteria. The following 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

C11. 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.

C12. 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.

C13. 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.

Medicare and Medicaid EHR Incentive Programs

C14. 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.

Medicare and Medicaid EHR Incentive Programs

C15. I have developed my own EHR technology. Does it have to be tested and certified by an ONC-ATCB? Can I submit my own EHR technology even though I am not a developer/vendor?

Participation in the ONC certification program is "voluntary" as described in the HITECH Act. Health care providers and eligible hospitals need to meaningfully use EHR technology certified by an ONC-ATCB to qualify for the Medicare and Medicaid EHR incentive programs. Certification is used to provide assurance that the EHR health care providers adopt has been tested and includes the required capabilities they need in order to use the technology in a meaningful way.

"Self-developed" or custom-developed EHR technology can be tested and certified by ONC-ATCBs.

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.

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 has issued the final rule related to the initial set of standards, implementation specifications, and certification criteria.

The Standards and Certification Final Rule

The Centers for Medicare and Medicaid Services also issued a final rule on the EHR Incentives Program

E2. When will the Permanent Certification Program Final Rule be published?

The Permanent Certification Program Final Rule was published in January 2011 and the program is expected to be operational in summer 2012.

Establishment of the Permanent Certification Program for Health Information Technology