Daily Rules, Proposed Rules, and Notices of the Federal Government
This final rule is issued under section 3004 of the Public Health Service Act.
C. Costs and Benefits
4. Explanation and Revision of Terms Used in Certification Criteria
The HIT Standards Committee (HITSC) issued recommendations for standards, implementation specifications, and certification criteria to the National Coordinator for Health Information Technology (the National Coordinator) on September 28, 2011 and
This final rule addresses comments received on the proposed rule and specifies the adoption by the Secretary, under sections 3004(a)(3) and 3004(b)(3) of the PHSA, of the standards, implementation specifications, and certification criteria that will establish the technical capabilities that electronic health record (EHR) technology must include to be certified. EHR technology certified to these standards, implementation specifications, and certification criteria makes it possible for eligible professionals (EPs), eligible hospitals (EHs), and critical access hospitals (CAHs) to adopt Certified EHR Technology (CEHRT) and subsequently attempt to demonstrate its meaningful use (MU) under the Medicare and Medicaid EHR Incentive Programs (the “EHR Incentive Programs”).
Consistent with Executive Order 13563, we have undertaken a retrospective review of our regulations. The final rule establishes multiple means for reducing regulatory burden and increasing regulatory flexibility for stakeholders, including changes to current regulatory requirements and approaches.
We have adopted certification criteria that will support the changes to the EHR Incentive Programs, including the new and revised objectives and measures for Stages 1 and 2 of MU finalized by CMS. The adopted certification criteria also enhance care coordination, patient engagement, and the security, safety, and efficacy of EHR technology. We refer to the adopted certification criteria as the 2014 Edition EHR certification criteria and the certification criteria previously adopted through rulemaking (75 FR 2014, 75 FR 44590) as the 2011 Edition EHR certification criteria. To permit efficient certification methods and reduce regulatory burden, we have identified those certification criteria that we have adopted as part of the 2014 Edition EHR certification criteria that include unchanged capabilities that were also included in the 2011 Edition EHR certification criteria. For EHR technology previously certified to the 2011 Edition EHR certification criteria, this will permit, where applicable, the use of prior test results for certification to the 2014 Edition EHR certification criteria (see the discussion of “gap certification” in section III.A.12 of this preamble).
Since the publication of the Standards and Certification Criteria final rule in July 2010, 75 FR 44590 (July 28, 2010) (the “S&CC July 2010 final rule”), HHS received significant feedback from stakeholders which suggested that we change our CEHRT policy (and definition) to one that would provide EPs, EHs, and CAHs the flexibility to have only the EHR technology they need to demonstrate MU. Consistent with stakeholder feedback and recommendations received from the HITSC, we proposed to revise the CEHRT definition to offer the requested flexibility. Based on comments received, we have finalized a CEHRT definition that provides even more flexibility for EPs, EHs, and CAHs than we originally proposed. In order to have EHR technology that meets the CEHRT definition for FY and CY 2014 and subsequent years, EPs, EHs, and CAHs must have EHR technology certified to the 2014 Edition EHR certification criteria that meets the Base EHR definition (EHR technology that includes fundamental capabilities all providers would need to have) as well as the additional EHR technology certified to the 2014 Edition EHR certification criteria necessary to meet the MU objectives and measures for the stage of MU that they seek to meet and to capture, calculate, and electronically submit clinical quality measures. In addition, this final rule permits EPs, EHs, and CAHs to adopt EHR technology that meets the FY/CY 2014 CEHRT definition and use it in their attempts to achieve MU prior to FY/CY 2014. We further discuss the new dynamic CEHRT definition, including the Base EHR definition in section III.B (“Redefining Certified EHR Technology and Related Terms”).
We note that we continue to permit only two types of EHR technology, Complete EHRs and EHR Modules, to be certified to meet these definitions under the “ONC HIT Certification Program.” A Complete EHR requires EHR technology to meet, at a minimum, all the mandatory certification criteria for either the ambulatory or inpatient setting, while an EHR Module can be any EHR technology certified to one less than all the mandatory certification criteria for either the ambulatory or inpatient setting (as noted, it would be a Complete EHR if it was certified to all the mandatory certification criteria for a setting). A Complete EHR, by definition, would meet the Base EHR definition and could be used to meet the CEHRT definition, but we note that an EP may need EHR technology certified to the optional “cancer registries” certification criteria to support their attempt to achieve MU. A single EHR Module could also be developed to meet the Base EHR definition and CEHRT definition for an EP, EH, or CAH. Additionally, an EP, EH, or CAH could use multiple certified EHR Modules or a certified EHR Module(s) in conjunction with a certified Complete EHR to meet the Base EHR definition and CEHRT definition.
This final rule revises the permanent certification program in ways that increase regulatory clarity and transparency, reduce regulatory burden, and add flexibility for the health information technology (HIT) community. One of these revisions includes changing the permanent certification program title to the “ONC HIT Certification Program,” which provides clearer attribution to the agency responsible for the program and an appropriate description of the program's scope, covering both current and potential future activities. The final rule also revises the process for permitting the use of newer versions of “minimum standard” code sets. The new approach is expected to reduce regulatory complexity and burden by providing the industry with the flexibility to utilize newer versions of adopted “minimum standard” code sets in a timelier manner.
The final rule modifies the certification processes ONC-Authorized Certification Bodies (ONC-ACBs) will need to follow for certifying EHR Modules in a manner that provides clear implementation direction and compliance with the new certification criteria. It also reduces regulatory burden by eliminating the certification requirement that every EHR Module be certified to the “privacy and security” certification criteria. Instead, the privacy and security capabilities are
To increase clarity for purchasers in the HIT market, we have established methods for representing certified Complete EHRs and certified EHR Modules, including when Complete EHRs and EHR Modules meet the Base EHR definition. We also require that test results used for EHR technology certification be made publicly available in an effort to increase transparency and provide EPs, EHs, and CAHs a potential starting point from which to assess any implementation issues associated with certified Complete EHRs and certified EHR Modules. Finally, as another means of increasing transparency and mitigating any potential confusion in the market, we require that ONC-ACBs ensure that EHR technology developers include in their marketing materials and communications notification to potential purchasers any additional types of costs that an EP, EH, or CAH would pay to implement their certified Complete EHR or certified EHR Module in order to attempt to meet MU objectives and measures.
We determined that this final rule is not an economically significant rule as its overall costs will be less than $100 million in any one year. We have, however, estimated the costs and benefits of the final rule. The final rule does not account for the estimated costs that EPs, EHs, and CAHs will incur in adopting and implementing certified Complete EHRs and certified EHR Modules. Those costs are estimated in the CMS Medicare and Medicaid EHR Incentive Programs Stage 2 final rule (Stage 2 final rule) published elsewhere in this issue of the
There are multiple potential benefits that stem from the 2014 Edition EHR certification criteria. Foremost, the 2014 Edition EHR certification criteria promote enhanced interoperability, functionality, utility, and security of EHR technology through the capabilities they include and the standards they require EHR technology to meet for certification. EHR technology certified to the 2014 Edition EHR certification criteria also will be capable of supporting EPs, EHs, and CAHs' attempts to demonstrate MU under the EHR Incentive Programs. The revised CEHRT definition, the availability of gap certification, and the revisions to the ONC HIT Certification Program, will, as noted, increase regulatory clarity, improve transparency, and add flexibility, while also reducing the regulatory burden on the HIT industry. Last, the provisions of this final rule are supportive of other initiatives, such as the Partnership for Patients, Medicare Shared Savings Program, and other quality measure programs administered by CMS.
The Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (the Recovery Act) (Pub. L. 111-5), was enacted on February 17, 2009. The HITECH Act amended the PHSA and created “Title XXX—Health Information Technology and Quality” (Title XXX) to improve health care quality, safety, and efficiency through the promotion of HIT and electronic health information exchange.
With the passage of the HITECH Act, two new Federal advisory committees were established, the HIT Policy Committee (HITPC) and the HIT Standards Committee (HITSC) (sections 3002 and 3003 of the PHSA, respectively). Each is responsible for advising the National Coordinator on different aspects of standards, implementation specifications, and certification criteria. The HITPC is responsible for, among other duties, recommending priorities for the development, harmonization, and recognition of standards, implementation specifications, and certification criteria. The HITPC also considers and provides recommendations to ONC and CMS on meaningful use (MU) policy under the EHR Incentive Programs. The HITSC is responsible for recommending standards, implementation specifications, and certification criteria for adoption by the Secretary under section 3004 of the PHSA consistent with the ONC-coordinated Federal Health IT Strategic Plan.
Section 3004 of the PHSA identifies a process for the adoption of health IT standards, implementation specifications, and certification criteria and authorizes the Secretary to adopt such standards, implementation
Section 3004(b)(3) of the PHSA titled “Subsequent Standards Activity” provides that the “Secretary shall adopt additional standards, implementation specifications, and certification criteria as necessary and consistent” with the schedule published by the HITSC. We consider this provision in the broader context of the HITECH Act to grant the Secretary the authority and discretion to adopt standards, implementation specifications, and certification criteria that have been recommended by the HITSC and endorsed by the National Coordinator, as well as other appropriate and necessary HIT standards, implementation specifications, and certification criteria. Throughout this process, the Secretary intends to continue to seek the insights and recommendations of the HITSC.
Section 3001(c)(5) of the PHSA provides the National Coordinator with the authority to establish a certification program or programs for the voluntary certification of HIT. Specifically, section 3001(c)(5)(A) specifies that the “National Coordinator, in consultation with the Director of the National Institute of Standards and Technology, shall keep or recognize a program or programs for the voluntary certification of health information technology as being in compliance with applicable certification criteria adopted under this subtitle” (i.e., certification criteria adopted by the Secretary under section 3004 of the PHSA). The certification program(s) must also “include, as appropriate, testing of the technology in accordance with section 13201(b) of the [HITECH] Act.”
Section 13201(b) of the HITECH Act requires that with respect to the development of standards and implementation specifications, the Director of the National Institute of Standards and Technology (NIST), in coordination with the HITSC, “shall support the establishment of a conformance testing infrastructure, including the development of technical test beds.” The HITECH Act also indicates that “[t]he development of this conformance testing infrastructure may include a program to accredit independent, non-Federal laboratories to perform testing.”
The Secretary issued an interim final rule with request for comments titled “Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology” (75 FR 2014, Jan. 13, 2010) (the “S&CC January 2010 interim final rule”), which adopted an initial set of standards, implementation specifications, and certification criteria. After consideration of the public comments received on the S&CC January 2010 interim final rule, a final rule was issued to complete the adoption of the initial set of standards, implementation specifications, and certification criteria and realign them with the final objectives and measures established for MU Stage 1. Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule, 75 FR 44590 (July 28, 2010). On October 13, 2010, an interim final rule with a request for comment was issued to remove certain implementation specifications related to public health surveillance that had been previously adopted in the S&CC July 2010 final rule (75 FR 62686).
The standards, implementation specifications, and certification criteria adopted by the Secretary in the S&CC July 2010 final rule established the capabilities that CEHRT must include in order to, at a minimum, support the achievement of MU Stage 1 by EPs, EHs, and CAHs under the Medicare and Medicaid EHR Incentive Programs Stage 1 final rule (the “Stage 1 final rule”) (see 75 FR 44314 for more information about MU and the Stage 1 requirements).
On March 7, 2012, ONC published a proposed rule (“the Proposed Rule”) (77 FR 13832) in the
On January 13, 2010, CMS published the EHR Incentive Programs Stage 1 proposed rule (75 FR 1844). The rule proposed a definition for Stage 1 MU of CEHRT and regulations associated with the incentive payments made available under Division B, Title IV of the HITECH Act. Subsequently, CMS published a final rule (75 FR 44314) for the EHR Incentive Programs on July 28, 2010, simultaneously with the publication of the S&CC July 2010 final rule. The Stage 1 final rule established the objectives, associated measures, and other requirements that EPs, EHs, and CAHs must satisfy to demonstrate MU during Stage 1.
On March 7, 2012, CMS published a proposed rule (77 FR 13698) in the
On March 10, 2010, ONC published a proposed rule (75 FR 11328) titled “Proposed Establishment of Certification Programs for Health Information Technology” (the “Certification Programs proposed rule”). The rule proposed both a temporary and permanent certification program for the purposes of testing and certifying HIT. It also specified the processes the National Coordinator would follow to authorize organizations to perform the certification of HIT. A final rule establishing the temporary certification program was published on June 24, 2010 (75 FR 36158) (the “Temporary Certification Program final rule”) and a final rule establishing the permanent certification program was published on January 7, 2011 (76 FR 1262) (“the Permanent Certification Program final rule”).
In the Proposed Rule mentioned above, ONC also proposed revisions to the permanent certification program, including changing the program's name to the ONC HIT Certification Program.
To make a clear distinction between previously adopted certification criteria and the ones proposed for adoption in the Proposed Rule, we stated we would refer to and define the certification criteria adopted in the S&CC July 2010 final rule and included in §§ 170.302, 170.304, and 170.306 collectively as the
In the Proposed Rule, we proposed new, revised, and unchanged certification criteria that would establish the technical capabilities and specify the related standards and implementation specifications that CEHRT would need to include to, at a minimum, support the achievement of MU by EPs, EHs, and CAHs under the EHR Incentive Programs beginning with the EHR reporting periods in FY/CY 2014. We referred to these new, revised, and unchanged certification criteria as the “2014 Edition EHR certification criteria” and proposed to add this term and its definition to § 170.102. Additionally, we proposed to include all of the 2014 Edition EHR certification criteria in § 170.314 to set them apart and make it easier for stakeholders to quickly determine which certification criteria would be required beginning with the EHR reporting periods that start in FY/CY 2014.
We believe by including all the 2014 Edition EHR certification criteria in one section of the CFR is a better approach than our previous approach of separating general, ambulatory, and inpatient certification criteria into three sections of the CFR. As noted in the Proposed Rule, the inclusion of all 2014 Edition EHR certification criteria in one regulatory section will simplify the regulatory framework for stakeholders.
Many of the certification criteria that we proposed supported the MU objectives and measures proposed by CMS in the Stage 2 proposed rule as well as the reporting of MU objectives and measures and clinical quality measures (CQMs). To the extent CMS has changed (e.g., added, revised, or removed) the MU objectives, measures, or reporting requirements in its final rule, we have made appropriate changes to the associated certification criteria so that they continue to support the MU objectives, measures, and reporting requirements.
We received many comments on the 2014 Edition EHR certification criteria that were not within this rulemaking's scope. These comments focused on the MU objectives, measures, CQM measures, and reporting requirements. For responses to such comments, we direct readers to the Stage 2 final rule published elsewhere in this issue of the
We reiterate and emphasize for commenters to remember that certification is a floor not a ceiling. It does not specify an exhaustive set of capabilities that EHR technology must include. Rather, certification assesses a subset of capabilities (generally capabilities that support MU requirements) that may be part of the overall EHR technology that an EP, EH, or CAH adopts. In this regard, certification focuses on providing assurance to EPs, EHs, and CAHs that EHR technology certified to a certification criterion includes the specified capabilities, that those capabilities perform correctly and, where applicable, that those capabilities properly utilize/support adopted standards.
We discuss the new, revised, and unchanged certification criteria that we are adopting as the 2014 Edition EHR certification criteria in sections A.8 through A.10 below. We include a table at the beginning of the discussion of each certification criterion or criteria that specifies the MU objective that the 2014 Edition EHR certification criterion or criteria support. The objective cited is either a Stage 1 or Stage 2 objective that will be effective for the EHR reporting periods in FY/CY 2014. We provide this frame of reference because beginning in FY/CY 2014 EHR technology will need to be certified to the 2014 Edition EHR certification criteria to meet the CEHRT definition and the tables clearly associate the certification criterion or criteria with the MU objective it supports. The tables also specify the CFR location for each certification criterion adopted in § 170.314.
Section 170.300 establishes the applicability of subpart C—Certification Criteria for Health Information Technology. Section 170.300(a) establishes the applicability of the adopted certification criteria to the testing and certification of Complete EHRs and EHR Modules. Section 170.300(b) specifies that when a certification criterion refers to two or more standards as alternatives, the use of at least one of the alternative standards will be considered compliant. Section 170.300(c) specifies that Complete EHRs and EHR Modules are not required to be compliant with certification criteria that are designated as optional.
We proposed to revise § 170.300 to reflect our proposed regulatory structure for the 2014 Edition EHR certification criteria. We proposed to revise paragraph (c) to add that Complete EHRs and EHR Modules are also not required to be certified to specific capabilities within a certification criterion that are designated as optional. We also proposed to add a paragraph (d) that would clarify which certification criteria or specific capabilities within a certification criterion included in § 170.314 have general applicability (i.e., apply to both ambulatory and inpatient settings) or apply only to an inpatient setting or an ambulatory setting.
In the Proposed Rule, based on our proposal to codify all the 2014 Edition EHR certification criteria in § 170.314, we clarified that certification to the certification criteria at § 170.314 would occur at the second paragraph level of the regulatory section. We noted that the first paragraph level in § 170.314 organizes the certification criteria into categories. These categories include: clinical (§ 170.314(a)); care coordination (§ 170.314(b)); clinical quality measures (§ 170.314(c)); privacy and security (§ 170.314(d)); patient engagement (§ 170.314(e)); public health (§ 170.314(f)); and utilization (§ 170.314(g)). Thus, we stated that a certification criterion in § 170.314 is at the second paragraph level and would encompass all of the specific capabilities in the paragraph levels below with, as noted in our discussion of “applicability,” an indication if the certification criterion or the specific capabilities within the criterion only apply to one setting (ambulatory or inpatient).
In the Proposed Rule, we noted that certain terms are repeatedly used in the proposed 2014 Edition EHR certification criteria. We stated that, based on our experience and stakeholder feedback related to how terms in the 2011 Edition EHR certification criteria have been interpreted, it was necessary in certain cases to select different terms. Therefore, we provided the following list of terms that are repeatedly used in the 2014 Edition EHR certification criteria and the intended meaning for each term.
“User” is used to mean a health care professional or his or her office staff or a software program or service that would interact directly with the CEHRT. This is essentially the same description that we gave to “user” in the S&CC July 2010 final rule (75 FR 44598). We clarified that, unless expressly stated otherwise, “user” does not mean a patient.
To provide further clarity for the 2014 Edition EHR certification criteria, we have revised a number of certification criteria to now begin with “EHR technology must be able to * * *” rather than “Enable a user to * * *.” We believe this approach more clearly communicates that the
We note, however, that we have taken two steps for certain vocabulary standards designated as minimum standards code sets. First, in this final rule we have adopted updated versions of four vocabulary standards that we proposed for certification in the Proposed Rule. We proposed the use of the January 2012 International Release of SNOMED CT®, but have adopted the July 2012 International Release of SNOMED CT® as well as the March 2012 U.S. Extension to SNOMED CT®. We proposed the use of version 2.38 of LOINC®, but have adopted version 2.40. We proposed the use of the February 2012 monthly version of RxNorm, but have adopted the August 2012 monthly version of RxNorm. We proposed the use of the August 15, 2011 version of CVX code sets, but have adopted the updated through July 11, 2012 version. In all these instances, we have found that the newer versions improve interoperability and EHR technology implementation, support MU, and do not create additional substantive requirements in comparison to the proposed versions of these vocabulary standards. Further, the adoption of these versions establishes the baseline in the CFR with the most recent versions of these vocabulary standards that is possible. Second, we have also established an approach that permits the use of newer versions of these standards than the one adopted in the CFR. We refer readers to section IV.B for a discussion of “minimum standards” code sets and our new more flexible approach for their use in certification and upgrading certified Complete EHRs and certified EHR Modules. Readers should also review § 170.555, which specifies the certification processes for “minimum standards” code sets.
We also believe that further clarity for stakeholders can be provided through the use of more specific descriptions for the different types of “data summaries” referenced in certification criteria. These specific descriptions are listed below and are used in the applicable certification criteria and referenced in the preamble discussions of the certification criteria. This revision is intended to make the data referenced in the final rule and the “data summary” to which it is assigned more readily apparent to readers. We note that the use of these specific descriptions in the certification criteria are for regulatory clarity purposes only and do not imply any additional meaning.
In the Proposed Rule, we described certification criteria that we considered “new.” We noted the following factors that we would consider when determining whether a certification criterion is “new”:
• The certification criterion only specifies capabilities that have never been included in previously adopted certification criteria; or
• The certification criterion was previously adopted as “mandatory” for a particular setting and subsequently adopted as “mandatory” or “optional” for a different setting.