Question [9-10-017-2]:

I am an eligible health care provider seeking to achieve “meaningful use of Certified EHR Technology” under the Medicare and Medicaid EHR Incentive Programs.  I understand that under the Medicare and Medicaid EHR Incentive Programs (“meaningful use”) Final Rule, I am permitted to defer up to 5 meaningful use “menu set” objectives and associated measures for a given EHR reporting period.  Do I need to possess EHR technology that has/have been tested and certified: A) to all of the applicable certification criteria adopted in ONC’s Standards and Certification Criteria Final Rule; or B) only to those certification criteria that correlate with the Stage 1 core set objectives and associated measures and menu set objectives and associated measures I select to report on to CMS?  

Answer:
“A - to all of the applicable certification criteria adopted in ONC’s Standards and Certification Criteria Final Rule.”

Eligibility to receive a Medicare or Medicaid EHR incentive payment consists of two related, but distinct steps – the possession of Certified EHR Technology and subsequently demonstrating its meaningful use.  In order to be able to attest to CMS or States at the end of your EHR reporting period that you possess EHR technology that meets the regulatory definition of Certified EHR Technology* adopted by HHS (45 CFR 170.102 and 42 CFR 495.4), the EHR technology in your possession must have been tested and certified to all applicable certification criteria adopted for the setting (ambulatory or inpatient) for which it was designed (see also CMS FAQ 10162).  Please see the discussion below for more on the meaning of “applicable certification criteria” as well as what is required for the EHR technology in your possession to meet the definition of Certified EHR Technology.

Step 1: Possession of Certified EHR Technology

As discussed in more detail in FAQ 12-10-21, we consider “possessing” (or “having”) Certified EHR Technology to include either the physical possession of medium on which a certified Complete EHR or combination of certified EHR Modules resides, or a legally enforceable right by an eligible health care provider to access and use, at its discretion, the capabilities a certified Complete EHR or combination of certified EHR Modules includes.  An eligible health care provider may determine the extent to which it will implement or use these capabilities, which will not affect the provider’s “possession” of Certified EHR Technology. 

Step 2: Demonstrating Meaningful Use of Certified EHR Technology

Generally stated, eligible health care providers, upon satisfying the core set objectives and measures, can choose 5 out of 10 menu set objectives and associated measures to satisfy the meaningful use requirements.  Consequently, our general rule is that an eligible health care provider for meaningful use Stage 1 must attest to having satisfied the combined 19 (eligible hospital) or 20 (eligible professionals) core and selected menu set objectives and associated measures using capabilities and standards Certified EHR Technology includes to successfully demonstrate meaningful use of Certified EHR Technology.  Stated another way, eligible health care providers will still be able to receive an incentive payment even if they are unable to demonstrate that they meet up to 5 of the meaningful use menu set objectives and associated measures.**

The definition of Certified EHR Technology does not vary based on the diverse combinations of menu set objectives and associated measures that each eligible health care provider could potentially select to satisfy the meaningful use requirements.  Rather, it specifies the minimum set of adopted certification criteria to which the EHR technology in an eligible health care provider’s possession must be tested and certified.  Some of our reasons for this approach include, but are not limited to, the following:

• ONC and CMS have noted that in future rulemaking, the Department will consider making the optional Stage 1 meaningful use objectives mandatory for Stage 2 (see, for example, 75 FR 44322).  Accordingly, the requirement that Certified EHR Technology support all Stage 1 objectives and associated measures creates a foundation eligible health care providers can build upon, without creating an obligation to meaningfully use each and every capability of Certified EHR Technology during Stage 1.
• We recognize that there will be a variety of circumstances and unanticipated implementation and workflow redesign challenges that will affect an eligible health care provider’s ability to both prepare itself to participate in the EHR incentive programs and subsequently demonstrate meaningful use of Certified EHR Technology.  By possessing Certified EHR Technology, eligible health care providers, especially those adopting EHR technology for the first time, will have the flexibility during an EHR reporting period to determine which menu set objectives and associated measures they will be capable of meeting or need to defer, in the event that one proves to be more difficult to meet than expected.
• We sought to accommodate the different legislative and programmatic requirements for the Medicare and Medicaid EHR Incentive Programs (e.g., Medicaid eligible health care providers are able to receive an incentive for adopting, upgrading, or implementing Certified EHR Technology in their first participation year and do not need to demonstrate meaningful use by satisfying the appropriate amount of core and menu set objectives and associated measures).

Meeting the Definition of Certified EHR Technology   

In the Standards and Certification Criteria Interim Final Rule (75 FR 2022), we explained what we meant by “applicable certification criteria” in the definition of Certified EHR Technology.  We stated that Congress indicated in the HITECH Act its expectation that different types of HIT would be certified, and it referenced two examples in the statutory definition of Certified EHR Technology: “an ambulatory electronic health record for office-based physicians” and “an inpatient hospital electronic health record for hospitals.”  We noted that certain meaningful use Stage 1 objectives and associated measures only apply to an eligible professional or to an eligible hospital and that these two types of providers require different capabilities from Certified EHR Technology.  Accordingly, we adopted specific certification criteria (at 45 CFR 170.304 and 45 CFR 170.306) that are only “applicable” to Complete EHRs or EHR Modules designed for use in an ambulatory setting (i.e., by eligible professionals) or an inpatient setting (i.e., by eligible hospitals).  Consequently, the Certified EHR Technology an eligible professional must possess does not need to include, for example, the capabilities to create an electronic copy of discharge instructions and record advance directives (45 CFR 170.306(e) and 45 CFR 170.306(h), respectively) as those certification criteria are not “applicable” to that type of EHR technology

We explained in the Standards and Certification Criteria Interim Final Rule and Final Rule (75 FR 2023 and 75 FR 44597, respectively) that a certified Complete EHR or a combination of certified EHR Modules must include all of the capabilities required by all of the applicable certification criteria to meet the definition of Certified EHR Technology.  In other words, for purposes of the definition of Certified EHR Technology, a certified Complete EHR and an equivalent combination of certified EHR Modules would have been tested and certified to the same applicable certification criteria.  We noted that if a combination of certified EHR Modules did not include all of the capabilities required by all applicable certification criteria, such a combination would not meet the definition of Certified EHR Technology. 

As an example (excluding the optional certification criterion at 45 CFR 170.302(w)), a Complete EHR designed for an ambulatory setting must be tested and certified to 32 certification criteria to meet the definition of Certified EHR Technology (i.e., the certification criteria adopted at 45 CFR 170.302(a)-(v) and 45 CFR 170.304(a)-(j)). Therefore, an equivalent combination of certified EHR Modules designed for an ambulatory setting would also need to include the capabilities required by those 32 certification criteria in order for the combination to meet the definition of Certified EHR Technology, regardless of the number of EHR Modules that make up the combination (Note: Under the temporary certification program, EHR Modules are subject to certain certification requirements with respect to privacy and security, see 45 CFR 170.450(d)).

Question [9-10-017-1]:Under the Medicare and Medicaid EHR Incentive Programs Final Rule, eligible health care providers are permitted to defer certain meaningful use objectives and measures and still receive an EHR incentive payment.  However, it is our understanding that in order for us to have our EHR technology certified, we must implement all of the applicable capabilities specified in the adopted certification criteria regardless of whether we intend to use all of those capabilities to qualify for our EHR incentive payment.  Is our understanding correct?

Answer:
Yes, this understanding is correct.  The flexibility offered as part of the Medicare and Medicaid EHR Incentive Programs Final Rule is not mirrored in the Initial Set of Standards, Implementation Specifications, and Certification Criteria Final Rule because we believe that it is important to accommodate eligible health care providers’ ability to achieve meaningful use.  We recognize that in some circumstances an eligible health care provider may not know which meaningful use measures they will seek to defer until they begin implementation and in others an individual provider (even within a specialty) will want to choose different measures to defer based on their local situation and implementation experience.  Thus, in order to possess EHR technology that meets the definition of Certified EHR Technology, it must be tested and certified by an ONC-ATCB to all applicable certification criteria adopted by the Secretary.

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