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 The leading web portal for pharmacy resources, news, education and careers September 19, 2017
Pharmacy Choice - Pharmaceutical News - HHS Seeks Comments on 2015 Edition Health Information Technology Certification Criteria - September 19, 2017

Pharmacy News Article

 3/29/15 - HHS Seeks Comments on 2015 Edition Health Information Technology Certification Criteria

Targeted News Service

WASHINGTON, March 29 The U.S. Department of Health & Human Services published the following proposed rule in the Federal Register:

2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications

A Proposed Rule by the Health and Human Services Department on 03/30/2015

Publication Date: Monday, March 30, 2015

Agencies: Office of the Secretary

Department of Health and Human Services

Dates: To be assured consideration, written or electronic comments must

Entry Type: Proposed Rule

Action: Notice of proposed rulemaking with comment period.

Document Citation: 80 FR 16804

Page: 16804 -16921 (118 pages)

CFR: 45 CFR 170

RIN: 0991-AB93

Document Number: 2015-06612

Shorter URL: https://federalregister.gov/a/2015-06612

Action

Notice Of Proposed Rulemaking With Comment Period.

Summary

This notice of proposed rulemaking introduces a new edition of certification criteria (the 2015 Edition health IT certification criteria or "2015 Edition"), proposes a new 2015 Edition Base EHR definition, and proposes to modify the ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings. The 2015 Edition would also establish the capabilities and specify the related standards and implementation specifications that Certified Electronic Health Record (EHR) Technology (CEHRT) would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) when such edition is required for use under these programs.

DATES:

To be assured consideration, written or electronic comments must be received at one of the addresses provided below, no later than 5 p.m. on May 29, 2015.

ADDRESSES:

You may submit comments, identified by RIN 0991-AB93, by any of the following methods (please do not submit duplicate comments). Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

Federal eRulemaking Portal: Follow the instructions for submitting comments. Attachments should be in Microsoft Word, Microsoft Excel, or Adobe PDF; however, we prefer Microsoft Word. http://www.regulations.gov.

Regular, Express, or Overnight Mail: Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Attention: 2015 Edition Health IT Certification Criteria Proposed Rule, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave SW., Washington, DC 20201. Please submit one original and two copies.

Hand Delivery or Courier: Office of the National Coordinator for Health Information Technology, Attention: 2015 Edition Health IT Certification Criteria Proposed Rule, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave SW., Washington, DC 20201. Please submit one original and two copies. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the mail drop slots located in the main lobby of the building.)

Enhancing the Public Comment Experience: To facilitate public comment on this proposed rule, a copy will be made available in Microsoft Word format. We believe this version will make it easier for commenters to access and copy portions of the proposed rule for use in their individual comments. Additionally, a separate document will be made available for the public to use to provide comments on the proposed rule. This document is meant to provide the public with a simple and organized way to submit comments on the certification criteria, associated standards and implementation specifications, and respond to specific questions posed in the preamble of the proposed rule. While use of this document is entirely voluntary, we encourage commenters to consider using the document in lieu of unstructured comments or to use it as an addendum to narrative cover pages. Roughly 30% of the public comments submitted to our past two editions of certification criteria proposed rules used the provided template, which greatly assisted in our ability to rapidly process and more accurately categorize public comments. Because of the technical nature of this proposed rule, we believe that use of the document may facilitate our review and understanding of the comments received. The Microsoft Word version of the proposed rule and the document that can be used for providing comments can be found at http://www.regulations.gov as part of this proposed rule's docket and on ONC's Web site (http://www.healthit.gov).

Inspection of Public Comments: All comments received before the close of the comment period will be available for public inspection, including any personally identifiable or confidential business information that is included in a comment. Please do not include anything in your comment submission that you do not wish to share with the general public. Such information includes, but is not limited to: a person's social security number; date of birth; driver's license number; state identification number or foreign country equivalent; passport number; financial account number; credit or debit card number; any personal health information; or any business information that could be considered proprietary. We will post all comments that are received before the close of the comment period at http://www.regulations.gov.

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov or the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave SW., Washington, DC 20201 (call ahead to the contact listed below to arrange for inspection).

FOR FURTHER INFORMATION CONTACT:

Michael Lipinski, Office of Policy, Office of the National Coordinator for Health Information Technology, 202-690-7151.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose of Regulatory Action

Building on past rulemakings, this proposed rule further identifies how health IT certification can support the establishment of an interoperable nationwide health information infrastructure. It reflects stakeholder feedback received through various outreach initiatives, including the regulatory process, and is designed to broadly support the health care continuum through the use of certified health IT. To achieve this goal, this rule proposes to:

Improve interoperability for specific purposes by adopting new and updated vocabulary and content standards for the structured recording and exchange of health information, including a Common Clinical Data Set composed primarily of data expressed using adopted standards; and rigorously testing an identified content exchange standard (Consolidated Clinical Document Architecture (C-CDA));

Facilitate the accessibility and exchange of data by including enhanced data portability, transitions of care, and application programming interface (API) capabilities in the 2015 Edition Base EHR definition;

Establish a framework that makes the ONC Health IT Certification Program open and accessible to more types of health IT, health IT that supports a variety of care and practice settings, various HHS programs, and public and private interests;

Support the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) through the adoption of a set of certification criteria that align with proposals for Stage 3;

Address health disparities by providing certification: To standards for the collection of social, psychological, and behavioral data; for the exchange of sensitive health information (Data Segmentation for Privacy); and for the accessibility of health IT;

Ensure all health IT presented for certification possess the relevant privacy and security capabilities;

Improve patient safety by: Applying enhanced user-center design principles to health IT, enhancing patient matching, requiring relevant patient information to be exchanged (e.g., Unique Device Identifiers), improving the surveillance of certified health IT, and making more information about certified products publicly available and accessible;

Increase the reliability and transparency of certified health IT through surveillance and disclosure requirements; and

Provide health IT developers with more flexibility and opportunities for certification that support both interoperability and innovation.

B. Summary of Major Provisions

1. Overview of the 2015 Edition Health IT Certification Criteria

The 2015 Edition health IT certification criteria ("2015 Edition") would facilitate greater interoperability for several clinical health information purposes and enable health information exchange through new and enhanced certification criteria, standards, and implementation specifications. It incorporates changes that are designed to spur innovation, open new market opportunities, and provide more choices to providers when it comes to electronic health information exchange. To achieve these goals, we propose a new "Application Access to Common Clinical Data Set" certification criterion that would require the demonstration of an API that responds to data requests for any one of the data referenced in the Common Clinical Data Set as well as for all of the data referenced in the Common Clinical Data Set. To further validate the continued interoperability of certified health IT and the ability to exchange health information, we propose a new certification criterion that would rigorously assess a product's C-CDA creation performance (for both C-CDA version 1.1 and 2.0) when presented for certification for such capabilities.

2. Definitions

a. Base EHR Definitions

We propose to adopt a Base EHR definition specific to the 2015 Edition (i.e., a 2015 Edition Base EHR definition) at section 170.102 and rename the current Base EHR definition at section 170.102 as the 2014 Edition Base EHR definition. For the proposed 2015 Edition Base EHR definition, it would differ from the 2014 Edition Base EHR definition in the following ways:

It does not include privacy and security capabilities and certification criteria. We believe privacy and security capabilities would be more appropriately addressed through our new proposed approach for the privacy and security certification of Health IT Modules to the 2015 Edition, as discussed under "Privacy and Security" in section IV.C.1 of the preamble. Our new privacy and security approach would eliminate eligible professionals (EPs)', eligible hospitals', and critical access hospitals (CAHs)' responsibilities to ensure that they have technology certified to all the necessary privacy and security criteria. Rather, as part of certification, health IT developers would need to meet applicable privacy and security certification criteria.

It only includes the capability to record and export CQM data (section 170.315(c)(1)). To note, the capabilities to import, calculate and report CQM data are not included in the proposed 2015 Edition Base EHR definition or any other CQM-related requirements. Please refer to the "Clinical Quality Measures" section (III.A.3) later in the preamble for a more detailed discussion of the CQM certification criteria. Please also see the EHR Incentive Programs Stage 3 proposed rule published elsewhere in this issue of the Federal Register for proposals related to CQMs, including the CEHRT definition proposal.

It includes the 2015 Edition "smoking status," "implantable device list," and "application access to Common Clinical Data Set" certification criteria. For a detailed discussion of these certification criteria, please refer to section III.A.3 of the preamble.

It includes the proposed 2015 Edition certification criteria that correspond to the remaining 2014 Edition certification criteria referenced in the "2014 Edition" Base EHR definition (i.e., Computerized Provider Order Entry (CPOE), demographics, problem list, medication list, medication allergy list, clinical decision support (CDS), transitions of care, data portability, and relevant transport certification criteria). On the inclusion of transport certification criteria, we propose to include the "Direct Project" criterion (section 170.315(h)(1)) as well as the "Direct Project, Edge Protocol and XDR/XDM" [1] criterion (section 170.315(h)(2)) as equivalent alternative means for meeting the 2015 Edition Base EHR definition for the reasons discussed under "Transport Methods and Other Protocols" in section III.A.3 of the preamble.

We refer readers to section III.B.1 for a more detailed discussion of the proposed 2015 Edition Base EHR definition.

b. CEHRT Definition

We propose to remove the Certified EHR Technology (CEHRT) definition from section 170.102 for the following reasons. The CEHRT definition has always been defined in a manner that supports the EHR Incentive Programs. As such, the CEHRT definition would more appropriately reside solely within the EHR Incentive Programs regulations. This would also be consistent with our approach in this proposed rule to make the ONC Health IT Certification Program more open and accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond those included in the EHR Incentive Programs. Further, this approach should add administrative simplicity in that regulatory provisions, which EHR Incentive Programs participants must meet (e.g., the CEHRT definition), would be defined within the context of rulemakings for those programs. We understand that the CEHRT definition proposed by CMS would continue to include the Base EHR definition(s) defined by ONC, including the 2015 Edition Base EHR definition proposed in this proposed rule. We also refer readers to Table 2 ("2015 Edition Proposed Certification Criteria Associated with the EHR Incentive Programs Stage 3") found in section III.A.3 of this preamble. Table 2 crosswalks proposed 2015 Edition certification criteria with the proposed CEHRT definition and proposed EHR Incentive Programs Stage 3 objectives.

c. Common Clinical Data Set

We propose to revise the "Common MU Data Set" definition in section 170.102. We propose to change the name to "Common Clinical Data Set," which aligns with our approach throughout this proposed rule to make the ONC Health IT Certification Program more open and accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond those included in the EHR Incentive Programs. We also propose to change references to the "Common MU Data Set" in the 2014 Edition (section 170.314) to "Common Clinical Data Set."

We propose to revise the definition to account for the new and updated standards and code sets we propose to adopt in this proposed rule that would improve and advance interoperability through the exchange of the Common Clinical Data Set. We also propose to revise the definition to support patient safety through clearly referenced data elements and the inclusion of new patient data. These proposed revisions would not change the standards, codes sets, and data requirements specified in the Common Clinical Data Set for 2014 Edition certification. They would only apply to health IT certified to the 2015 Edition Health IT certification criteria that reference the Common Clinical Data Set.

3. The ONC Health IT Certification Program and Health IT Module

We propose to change the name of the ONC HIT Certification Program to the "ONC Health IT Certification Program" (referred to as the "ONC Health IT Certification Program" throughout this proposed rule). We also propose to modify the ONC Health IT Certification Program in ways that would further open access to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond the ambulatory and inpatient settings. These modifications would also serve to support other public and private programs that may reference the use of health IT certified under the ONC Health IT Certification Program. When we established the certification program (76 FR 1294), we stated our initial focus would be on EHR technology and supporting the EHR Incentive Programs, which focus on the ambulatory setting and inpatient setting. Our proposals in this proposed rule would permit other types of health IT (e.g., laboratory information systems (LISs)), and technology implemented by health information service providers (HISPs) and health information exchanges (HIEs)) to receive appropriate attribution and not be referenced by a certificate with "EHR" in it. Our proposals also support health IT certification for other care and practice settings such as long-term post-acute care (LTPAC), behavioral health, and pediatrics. Further, the proposals in this rule would make it simpler for certification criteria and certified health IT to be referenced by other HHS programs (e.g., Medicaid and Medicare payment programs and various grant programs), other public programs, and private entities and associations.

As part of our approach to evolve the ONC Health IT Certification Program, we have replaced prior rulemaking use of "EHR" and "EHR technology" with "health IT." The term health IT is reflective of the scope of ONC's authority under the Public Health Service Act (section 3000(5) as "health information technology" is so defined), and represents a broad range of technology, including EHR technology. It also more properly represents some of the technology, as noted above, that has been previously certified to editions of certification criteria under the ONC Health IT Certification Program and may be certified to the proposed 2015 Edition in the future. Similarly, to make the ONC Health IT Certification Program more open and accessible, we propose to rename the EHR Module as "Health IT Module" and will use this term throughout the proposed rule.

We propose not to require ONC-Authorized Certification Bodies (ACBs) to certify all Health IT Modules to the 2015 Edition "meaningful use measurement" certification criteria (section 170.315(g)(1) "automated numerator recording" and section 170.315(g)(2) "automated measure calculation"). We note that CMS has proposed to include the 2015 Edition "meaningful use measurement" certification criteria in the CEHRT definition as a unique program requirement for the EHR Incentive Programs.

We propose a new, simpler, straight-forward approach to privacy and security certification requirements for Health IT Modules certified to the 2015 Edition. In essence, we identify the privacy and security certification criteria that would be applicable to a Health IT Module presented for certification based on the other capabilities included in the Health IT Module and for which certification is sought. Under the proposed approach, a health IT developer would know exactly what it needed to do in order to get its Health IT Module certified and a purchaser of a Health IT Module would know exactly what privacy and security functionality against which the Health IT Module had to be tested in order to be certified.

We propose new and revised principles of proper conduct (PoPC) for ONC-ACBs. We propose to require ONC-ACBs to report an expanded set of information to ONC for inclusion in the open data file that would make up the Certified Health IT Product List (CHPL). We propose to revise the PoPC in order to provide for more meaningful disclosure of certain types of costs and limitations that could interfere with the ability of users to implement certified health IT in a manner consistent with its certification. We propose that ONC-ACBs retain records longer and consistent with industry standards. We propose to require that ONC-ACBs obtain a record of all adaptations and updates, including changes to user-facing aspects, made to certified health IT, on a monthly basis each calendar year. We propose to require that ONC-ACBs report to the National Coordinator complaints received on certified health IT. We propose to adopt new requirements for "in-the-field" surveillance under the ONC Health IT Certification Program that would build on ONC-ACBs' existing surveillance responsibilities by specifying requirements and procedures for in-the-field surveillance. We believe these proposed new and revised PoPC would promote greater transparency and accountability for the ONC Health IT Certification Program. We also include a request for comment on the potential "decertification" of health IT that proactively blocks the sharing of information.

C. Costs and Benefits

Our estimates indicate that this proposed rule is an economically significant rule as its overall costs for health IT developers may be greater than $100 million in at least one year. We have, therefore, projected the costs and benefits of the proposed rule. The estimated costs expected to be incurred by health IT developers to develop and prepare health IT to be tested and certified in accordance with the 2015 Edition health IT certification criteria (and the standards and implementation specifications they include) are represented in monetary terms in Table 1 below. We note that this proposed rule does not impose the costs cited as compliance costs, but rather as investments which health IT developers voluntarily take on and expect to recover with an appropriate rate of return.

The dollar amounts expressed in Table 1 are expressed in 2013 dollars. Table 1Distributed Total Development and Preparation Costs for Health IT Developers (4-Year Period)Totals Rounded

Year .....Ratio (%) .....Total low cost estimate ($M) .....Total high cost estimate ($M) .....Total average cost estimate ($M)

2015 .....25 .....49.36 .....101.80 .....75.58

2016 .....30 .....59.23 .....122.16 .....90.70

2017 .....30 .....59.23 .....122.16 .....90.70

2018 .....15 .....29.61 .....61.08 .....45.35

4-Year Totals ..........197.43 .....407.20 .....302.32

We believe that there will be several significant benefits that may arise from this proposed rule for patients, health care providers, and health IT developers. The 2015 Edition continues to improve health IT interoperability through the adoption of new and updated standards and implementation specifications. For example, many proposed certification criteria include standards and implementation specifications for interoperability that directly support the EHR Incentive Programs, which include objectives and measures for the interoperable exchange of health information and for providing patients electronic access to their health information in structured formats. In addition, proposed certification criteria that support the collection of patient data that could be used to address health disparities would not only benefit patients, but the entire health care delivery system through improved quality of care. The 2015 Edition also supports usability and patient safety through new and enhanced certification requirements for health IT.

Our proposals to make the ONC Health IT Certification Program open and accessible to more types of health IT and for health IT that supports a variety of care and practice settings should benefit health IT developers, providers practicing in other care/practice settings, and consumers through the availability and use of certified health IT that includes capabilities that promote interoperability and enhanced functionality.

II. Background

A. Statutory Basis

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 Public Health Service Act (PHSA) and created "Title XXXHealth Information Technology and Quality" (Title XXX) to improve health care quality, safety, and efficiency through the promotion of HIT and electronic health information exchange.

1. Standards, Implementation Specifications, and Certification Criteria

The HITECH Act established two new federal advisory committees, the Health IT Policy Committee (HITPC) and the Health IT Standards Committee (HITSC) (sections 3002 and 3003 of the PHSA, respectively). Each is responsible for advising the National Coordinator for Health Information Technology (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. Main responsibilities of the HITSC include 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 specifications, and certification criteria. As specified in section 3004(a)(1), the Secretary is required, in consultation with representatives of other relevant federal agencies, to jointly review standards, implementation specifications, and certification criteria endorsed by the National Coordinator under section 3001(c) and subsequently determine whether to propose the adoption of any grouping of such standards, implementation specifications, or certification criteria. The Secretary is required to publish all determinations in the Federal Register.

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 health IT standards, implementation specifications, and certification criteria. Throughout this process, the Secretary intends to continue to seek the insights and recommendations of the HITSC.

2. Health IT Certification Programs

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 health IT. 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. Overall, 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 the development of this conformance testing infrastructure may include a program to accredit independent, non-Federal laboratories to perform testing.

B. Regulatory History

1. Standards, Implementation Specifications, and Certification Criteria Rules

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 the EHR Incentive Programs Stage 1 (formally titled: 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) and referred to as the "2011 Edition final rule"). The 2011 Edition final rule also established the first version of the Certified EHR Technology (CEHRT) definition. Subsequent to the 2011 Edition final rule (October 13, 2010), we issued an interim final rule with a request for comment to remove certain implementation specifications related to public health surveillance that had been previously adopted in the 2011 Edition final rule (75 FR 62686).

The standards, implementation specifications, and certification criteria adopted by the Secretary in the 2011 Edition final rule established the capabilities that CEHRT must include in order to, at a minimum, support the achievement of EHR Incentive Programs Stage 1 by EPs, eligible hospitals, and CAHs under the EHR Incentive Programs Stage 1 final rule (the "EHR Incentive Programs Stage 1 final rule") (see 75 FR 44314 for more information about meaningful use and the Stage 1 requirements).

The Secretary issued a proposed rule with request for comments titled "Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology" (77 FR 13832, March 7, 2012) (the "2014 Edition proposed rule"), which proposed new and revised standards, implementation specifications, and certification criteria. After consideration of the public comments received on the 2014 Edition proposed rule, a final rule was issued to adopt the 2014 Edition set of standards, implementation specifications, and certification criteria and realign them with the final objectives and measures established for the EHR Incentive Programs Stage 2 as well as Stage 1 revisions (Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology (77 FR 54163, Sept. 4, 2012) (the "2014 Edition final rule"). The standards, implementation specifications, and certification criteria adopted by the Secretary in the 2014 Edition final rule established the capabilities that CEHRT must include in order to, at a minimum, support the achievement of the EHR Incentive Programs Stage 2 by EPs, eligible hospitals, and CAHs under the EHR Incentive Programs Stage 2 final rule (the "EHR Incentive Programs Stage 2 final rule") (see 77 FR 53968 for more information about the EHR Incentive Programs Stage 2 requirements).

On December 7, 2012, an interim final rule with a request for comment was jointly issued and published by ONC and CMS to update certain standards that had been previously adopted in the 2014 Edition final rule. The interim final rule also revised the EHR Incentive Programs by adding an alternative measure for the Stage 2 objective for hospitals to provide structured electronic laboratory results to ambulatory providers, corrected the regulation text for the measures associated with the objective for hospitals to provide patients the ability to view online, download, and transmit information about a hospital admission, and made the case number threshold exemption policy for clinical quality measure (CQM) reporting applicable for eligible hospitals and CAHs beginning with FY 2013. The rule also provided notice of CMS's intent to issue technical corrections to the electronic specifications for CQMs released on October 25, 2012 (77 FR 72985). On September 4, 2014, a final rule (Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program for 2014 and Other Changes to the EHR Incentive Program; and Health Information Technology: Revisions to the Certified EHR Technology Definition and EHR Certification Changes Related to Standards; Final Rule) (79 FR 52910) was published adopting these proposals.

On November 4, 2013, the Secretary published an interim final rule with a request for comment, 2014 Edition Electronic Health Record Certification Criteria: Revision to the Definition of "Common Meaningful Use (MU) Data Set" (78 FR 65884), to make a minor revision to the Common MU Data Set definition. This revision was intended to allow more flexibility with respect to the representation of dental procedures data for EHR technology testing and certification.

On February 26, 2014, the Secretary published a proposed rule titled "Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements" (79 FR 10880) ("Voluntary Edition proposed rule"). The proposed rule proposed a voluntary edition of certification criteria that was designed to enhance interoperability, promote innovation, and incorporate "bug fixes" to improve upon the 2014 Edition. A correction notice was published for the Voluntary Edition proposed rule on March 19, 2014, entitled "Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements; Correction" (79 FR 15282). This correction notice corrected the preamble text and gap certification table for four certification criteria that were omitted from the list of certification criteria eligible for gap certification for the 2015 Edition EHR certification criteria. On September 11, 2014, a final rule was published titled "2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange" (79 FR 54430) ("2014 Edition Release 2 final rule"). The final rule adopted a small subset of the original proposals in the Voluntary Edition proposed rule as optional and revised 2014 Edition EHR certification criteria that provide flexibility, clarity, and enhance health information exchange. It also finalized administrative proposals (i.e., removal of regulatory text from the Code of Federal Regulations (CFR)) and proposals for the ONC HIT Certification Program that provide improvements.

On May 23, 2014, CMS and ONC jointly published the "Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record Incentive Programs for 2014; and Health Information Technology: Revisions to the Certified EHR Technology Definition" proposed rule (79 FR 29732). The rule proposed to update the EHR Incentive Programs Stage 2 and Stage 3 participation timeline. It proposed to revise the CEHRT definition to permit the use of EHR technology certified to the 2011 Edition to meet the CEHRT definition for FY/CY 2014. It also proposed to allow EPs, eligible hospitals, and CAHs that could not fully implement EHR technology certified to the 2014 Edition for an EHR reporting period in 2014 due to delays in the availability of such technology to continue to use EHR technology certified to the 2011 Edition or a combination of EHR technology certified to the 2011 Edition and 2014 Edition for the EHR reporting periods in CY 2014 and FY 2014. On September 4, 2014, a final rule ("CEHRT Flexibility final rule") was published (79 FR 52910) adopting these proposals.

2. Medicare and Medicaid EHR Incentive Programs Rules

On January 13, 2010, CMS published the EHR Incentive Programs Stage 1 proposed rule (75 FR 1844). The rule proposed the criteria for Stage 1 of the EHR Incentive Programs 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 Stage 1 and the EHR Incentive Programs on July 28, 2010, simultaneously with the publication of the 2011 Edition final rule. The EHR Incentive Programs Stage 1 final rule established the objectives, associated measures, and other requirements that EPs, eligible hospitals, and CAHs must satisfy to meet Stage 1.

On March 7, 2012, CMS published the EHR Incentive Programs Stage 2 proposed rule (77 FR 13698). Subsequently, CMS published a final rule (77 FR 53968) for the EHR Incentive Programs on Sept. 4, 2012, simultaneously with the publication of the 2014 Edition final rule. The EHR Incentive Programs Stage 2 final rule established the objectives, associated measures, and other requirements that EPs, eligible hospitals, and CAHs must satisfy to meet Stage 2 as well as revised some Stage 1 requirements.

As described above in Section II.B.1, ONC and CMS jointly issued an interim final rule with a request for comment that was published on December 7, 2012 and a final rule that published on September 4, 2014. Also, as described above in Section II.B.1, ONC and CMS jointly issued proposed and final rules that were published on May 23, 2014 and September 4, 2014, respectively.

3. ONC Health IT Certification Program Rules

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) ("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").

On May 31, 2011, ONC published a proposed rule (76 FR 31272) titled "Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved Accreditor Processes." The rule proposed a process for addressing instances where the ONC-Approved Accreditor (ONC-AA) engaged in improper conduct or did not perform its responsibilities under the permanent certification program, addressed the status of ONC-Authorized Certification Bodies in instances where there may be a change in the accreditation organization serving as the ONC-AA, and clarified the responsibilities of the new ONC-AA. All these proposals were finalized in a final rule published on November 25, 2011 (76 FR 72636).

The 2014 Edition final rule made changes to the permanent certification program. The final rule adopted a proposal to change the Permanent Certification Program's name to the "ONC HIT Certification Program," revised the process for permitting the use of newer versions of "minimum standard" code sets, modified the certification processes ONC-ACBs need to follow for certifying EHR Modules in a manner that provides clear implementation direction and compliance with the new certification criteria, and eliminated the certification requirement that every EHR Module be certified to all the mandatory "privacy and security" certification criteria.

The Voluntary Edition proposed rule included proposals that focused on improving regulatory clarity, simplifying the certification of EHR Modules that are designed for purposes other than meeting Meaningful Use requirements, and discontinuing the use of the Complete EHR definition. As noted above, we issued the 2014 Edition Release 2 final rule to complete the rulemaking for the Voluntary Edition proposed rule. The 2014 Edition Release 2 final rule discontinued the "Complete EHR" certification concept beginning with the proposed 2015 Edition, adopted an updated standard (ISO/IEC 17065) for the accreditation of ONC-ACBs, and adopted the "ONC Certified HIT" certification and design mark for required use by ONC-ACBs under the ONC Health IT Certification Program.

III. Provisions of the Proposed Rule Affecting Standards, Implementation Specifications, and Certification Criteria

A. 2015 Edition Health IT Certification Criteria

This rule proposes new, revised, and unchanged certification criteria that would establish the capabilities and related standards and implementation specifications for the certification of health IT, including EHR technology. We refer to these new, revised, and unchanged certification criteria as the "2015 Edition health IT certification criteria" and propose to add this term and its definition to section 170.102. As noted in the Executive Summary, we also refer to these criteria as the "2015 Edition" in this preamble. We propose to codify the 2015 Edition in section 170.315 to set them apart from other editions of certification criteria and make it easier for stakeholders to quickly determine the certification criteria the 2015 Edition includes.

Health IT certified to these proposed certification criteria and associated standards and implementation specifications could be implemented as part of an EP's, eligible hospital's, or CAH's CEHRT and used to demonstrate meaningful use (as identified in Table 2 below). We note that Table 2 does not identify certification criteria that are included in conditional certification requirements, such as privacy and security, safety-enhanced design, and quality management system certification criteria. We do, however, classify these types of certification criteria as "associated" with the EHR Incentives Programs Stage 3 for the purposes of the regulatory impact analysis we performed for this proposed rule (see section VIII.B.1).

Health IT certified to the proposed certification criteria and associated standards and implementation specifications could also be used to meet other HHS program requirements (e.g., grant and contract requirements) or referenced by private sector associations and entities.

Table 22015 Edition Proposed Certification Criteria Associated With the EHR Incentive Programs Stage 3

Proposed CFR citation .....Certification criterion .....Proposed inclusion in 2015 edition base EHR definition .....Relationship to the proposed CEHRT2definition and proposed stage 3 objectives

2CMS' CEHRT definition would include the criteria adopted in the Base EHR definition. For more details on the CEHRT definition, please see the CMS EHR Incentive Programs proposed rule published elsewhere in this issue of the Federal Register.

3Technology needs to be certified to section 170.315(a)(1), (a)(2), or (a)(3).

4Technology needs to be certified to section 170.315(a)(1), (a)(2), or (a)(3).

5Technology needs to be certified to section 170.315(a)(1), (a)(2), or (a)(3).

6Technology needs to be certified to section 170.315(a)(14) or (a)(15).

7Technology needs to be certified to section 170.315(a)(14) or (a)(15).

8As discussed in the preamble for the "clinical quality measuresreport" criterion, additional CQM certification policy may be proposed in or with CMS payment rules in CY15. As such, additional CQM certification criteria may be proposed for the Base EHR and/or CEHRT definitions.

9For the public health certification criteria in section 170.315(f), technology would only need to be certified to those criteria that are required to meet the options the provider intends to report in order to meet the proposed Objective 8: Public Health and Clinical Data Registry Reporting.

10Technology needs to be certified to section 170.315(h)(1) or (h)(2) to meet the proposed Base EHR definition.

11Technology needs to be certified to section 170.315(h)(1) or (h)(2) to meet the proposed Base EHR definition.

section 170.315(a)(1) .....Computerized Provider Order Entry (CPOE)medications .....Included3 .....Objective 4.

section 170.315(a)(2) .....CPOElaboratory .....Included4 .....Objective 4.

section 170.315(a)(3) .....CPOEdiagnostic imaging .....Included5 .....Objective 4.

section 170.315(a)(4) .....Drug-drug, Drug-allergy Interaction Checks for CPOE .....Not included .....Objective 3.

section 170.315(a)(5) .....Demographics .....Included .....No additional relationship beyond the Base EHR definition.

section 170.315(a)(7) .....Problem List .....Included .....No additional relationship beyond the Base EHR definition.

section 170.315(a)(8) .....Medication List .....Included .....No additional relationship beyond the Base EHR definition.

section 170.315(a)(9) .....Medication Allergy List .....Included .....No additional relationship beyond the Base EHR definition.

section 170.315(a)(10) .....Clinical Decision Support .....Included .....Objective 3.

section 170.315(a)(11) .....Drug-formulary and Preferred Drug List Checks .....Not included .....Objective 2.

section 170.315(a)(12) .....Smoking Status .....Included .....No additional relationship beyond the Base EHR definition.

section 170.315(a)(14) .....Family Health History .....Not included .....CEHRT6.

section 170.315(a)(15) .....Family Health Historypedigree .....Not included .....CEHRT7.

section 170.315(a)(17) .....Patient-specific Education Resources .....Not included .....Objective 5.

section 170.315(a)(19) .....Patient Health Information Capture .....Not included .....CEHRT Objective 6.

section 170.315(a)(20) .....Implantable Device List .....Included .....No additional relationship beyond the Base EHR definition.

section 170.315(b)(1) .....Transitions of Care .....Included .....Objective 7.

section 170.315(b)(2) .....Clinical Information Reconciliation and Incorporation .....Not included .....Objective 7.

section 170.315(b)(3) .....Electronic Prescribing .....Not included .....Objective 2.

section 170.315(b)(6) .....Data Portability .....Included .....No additional relationship beyond the Base EHR definition.

section 170.315(c)(1)8 .....Clinical Quality Measuresrecord and export .....Included .....CEHRT.

section 170.315(e)(1) .....View, Download, and Transmit to Third Party .....Not included .....Objective 5 Objective 6.

section 170.315(e)(2) .....Secure Messaging .....Not included .....Objective 6.

section 170.315(f)(1) .....Transmission to Immunization Registries .....Not included .....Objective 8.9

section 170.315(f)(2) .....Transmission to Public Health Agenciessyndromic surveillance .....Not included .....Objective 8.

section 170.315(f)(3) .....Transmission to Public Health Agenciesreportable laboratory tests and values/results .....Not included .....Objective 8.

section 170.315(f)(4) .....Transmission to Cancer Registries .....Not included .....Objective 8.

section 170.315(f)(5) .....Transmission to Public Health Agenciescase reporting .....Not included .....Objective 8.

section 170.315(f)(6) .....Transmission to Public Health Agenciesantimicrobial use and resistance reporting .....Not included .....Objective 8.

section 170.315(f)(7) .....Transmission to Public Health Agencieshealth care surveys .....Not included .....Objective 8.

section 170.315(g)(1) .....Automated Numerator Recording .....Not included .....CEHRT.

section 170.315(g)(2) .....Automated Measure Calculation .....Not included .....CEHRT.

section 170.315(g)(7) .....Application Access to Common Clinical Data Set .....Included .....Objective 5 Objective 6.

section 170.315(h)(1) .....Direct Project .....Included10 .....No additional relationship beyond the Base EHR definition.

section 170.315(h)(2) .....Direct Project, Edge Protocol, and XDR/XDM .....Included11 .....No additional relationship beyond the Base EHR definition.

1. Applicability

Section 170.300 establishes the applicability of subpart CCertification Criteria for Health Information Technology. We propose to revise paragraph (d) of section 170.300 to add in a reference to section 170.315 and revise the parenthetical in the paragraph to say "i.e., apply to any health care setting" instead of "i.e., apply to both ambulatory and inpatient settings." These proposed revisions would clarify which specific capabilities within a certification criterion included in section 170.315 have general applicability (i.e., apply to any health care setting) or apply only to an inpatient setting or an ambulatory setting. The proposed revision to change the language of the parenthetical aligns with our proposed approach to make the ONC Health IT Certification Program more agnostic to health care settings and accessible to health IT that supports care and practice settings beyond the ambulatory and inpatient settings. We refer readers to section IV.B of this preamble for a detailed discussion of our proposals to modify the ONC Health IT Certification Program.

We note that, with the proposed 2015 Edition, we no longer label certification criteria as either optional or ambulatory/inpatient (at the second paragraph level). For example, the proposed 2015 Edition certification criterion for electronic medication administration record is simply "electronic medication administration record" instead of "inpatient setting onlyelectronic medication administration record." Similarly, the proposed 2015 Edition certification criterion for "accounting of disclosures" is simply "accounting of disclosures" instead of "optionalaccounting of disclosures." These simplifications are possible given that, beginning with the 2015 Edition health IT certification criteria, "Complete EHR" certifications will no longer be issued (see 79 FR 54443-45). Therefore, there is no longer a need to designate an entire certification criterion in this manner. Again, this approach supports our goal to make the ONC Health IT Certification Program more agnostic to health care settings and accessible to health IT that supports care and practice settings beyond the ambulatory and inpatient settings.

We propose to replace the term "EHR technology" in paragraphs (d)(1) and (d)(2) with "health IT" to align with our proposed approach to make the ONC Health IT Certification Program more clearly open to the certification of all types of health IT. Again, we refer readers to section IV.B of this preamble for a detail discussion of our proposals to modify the ONC Health IT Certification Program.

2. Standards and Implementation Specifications

a. National Technology Transfer and Advancement Act

The National Technology Transfer and Advancement Act (NTTAA) of 1995 (15 U.S.C. section 3701 et. seq.) and the Office of Management and Budget (OMB) Circular A-119 [12] require the use of, wherever practical, technical standards that are developed or adopted by voluntary consensus standards bodies to carry out policy objectives or activities, with certain exceptions. The NTTAA and OMB Circular A-119 provide exceptions to selecting only standards developed or adopted by voluntary consensus standards bodies, namely when doing so would be inconsistent with applicable law or otherwise impractical. In this proposed rule, we refer to voluntary consensus standards, except for:

The standards adopted in section 170.202. (These standards were developed by groups of industry stakeholders committed to advancing the Direct Project, [13] which included initiatives under the Standards and Interoperability (S&I) Framework. [14] These groups used consensus processes similar to those used by other industry stakeholders and voluntary consensus standards bodies.);

The standards we propose to adopt at section 170.205(a)(5)(iii) and (iv) for electronic submission medical documentation (esMD) (These standards were developed by groups of industry stakeholders committed to advancing esMD, [15] which included initiatives under the Standards and Interoperability (S&I) Framework. [16] These groups used consensus processes similar to those used by other industry stakeholders and voluntary consensus standards bodies.);

The standards we propose to adopt at section 170.205(d)(4) and (e)(4) for reporting of syndromic surveillance and immunization information to public health agencies, respectively (These standards go through a process similar within the public health community to those used by other industry stakeholders and voluntary consensus standards bodies.);

The standard we propose to adopt at section 170.207(f)(2) for race and ethnicity; and

Certain standards related to the protection of electronic health information adopted in section 170.210.

We are aware of no voluntary consensus standard that would serve as an alternative to these standards for the purposes that we have identified in this proposed rule.

b. Compliance With Adopted Standards and Implementation Specifications

In accordance with Office of the Federal Register regulations related to "incorporation by reference," 1 CFR part 51, which we follow when we adopt proposed standards and/or implementation specifications in any subsequent final rule, the entire standard or implementation specification document is deemed published in the Federal Register when incorporated by reference therein with the approval of the Director of the Federal Register. Once published, compliance with the standard and implementation specification includes the entire document unless we specify otherwise. For example, if we adopted the HL7 Laboratory Orders Interface (LOI) implementation guide (IG) proposed in this proposed rule, health IT certified to certification criteria referencing this IG would need to demonstrate compliance with all mandatory elements and requirements of the IG. If an element of the IG is optional or permissive in any way, it would remain that way for testing and certification unless we specified otherwise in regulation. In such cases, the regulatory text would preempt the permissiveness of the IG.

c. "Reasonably Available" to Interested Parties

The Office of the Federal Register has established new requirements for materials (e.g., standards and implementation specifications) that agencies propose to incorporate by reference in the Federal Register (79 FR 66267; 1 CFR 51.5(a)). To comply with these requirements, in section VI ("Incorporation by Reference") of this preamble, we provide summaries of, and uniform resource locators (URLs) to, the standards and implementation specifications we propose to adopt and subsequently incorporate by reference in the Federal Register. To note, we also provide relevant information about these standards and implementation specifications throughout this section of the preamble (section III), including URLs.

d. "Minimum Standards" Code Sets

We propose to adopt newer versions of four previously adopted minimum standards code sets in this proposed rule for the 2015 Edition. These code sets are the September 2014 Release of the U.S. Edition of SNOMED CT(TM), LOINC(TM) version 2.50, the February 2, 2015 monthly version of RxNorm, and the February 2, 2015 version of the CVX code set. We also propose to adopt two new minimum standards code sets (the National Drug Codes (NDC)Vaccine Codes, updates through January 15, 2015 and the "Race & EthnicityCDC" code system in the PHIN Vocabulary Access and Distribution System (VADS) Release 3.3.9 (June 17, 2011)). As we have previously articulated (77 FR 54170), the adoption of newer versions improve interoperability and health IT implementation, while creating little additional burden through the inclusion of new codes. As many of these minimum standards code sets are updated frequently throughout the year, we will consider whether it may be more appropriate to adopt a version of a minimum standards code set that is issued before we publish a final rule for this proposed rule. In making such determination, as we have done with these proposed versions of minimum standards code sets, we will give consideration to whether it includes any new substantive requirements and its effect on interoperability. If adopted, a newer version of a minimum standards code set would serve as the baseline for certification. As with all adopted minimum standards code sets, health IT can be certified to newer versions of the adopted baseline version minimum standards code sets for purposes of certification, unless the Secretary specifically prohibits the use of a newer version (see section 170.555 and 77 FR 54268).

e. Object Identifiers (OIDs) for Certain Code Systems

We are providing the following table of OIDs for certain code systems to assist health IT developers in the proper identification and exchange of health information coded to the vocabulary standards proposed in this proposed rule.

Code system OID .....Code system name

2.16.840.1.113883.6.96 .....IHTSDO SNOMED CT.(TM)

2.16.840.1.113883.6.1 .....LOINC.(TM)

2.16.840.1.113883.6.88 .....RxNorm.

2.16.840.1.113883.12.292 .....HL7 Standard Code Set CVX-Vaccines Administered.

2.16.840.1.113883.6.69 .....National Drug Code Directory.

2.16.840.1.113883.6.8 .....Unified Code of Units of Measure (UCUM17).

2.16.840.1.113883.6.13 .....Code on Dental Procedures and Nomenclature (CDT).

2.16.840.1.113883.6.4 .....International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS).

2.16.840.1.113883.6.238 .....Race & EthnicityCenters for Disease Control and Prevention (CDC).

2.16.840.1.113883.6.316 .....Tags for Identifying LanguagesRequest for Comment (RFC) 5646 (preferred language).

f. Subpart BStandards and Implementation Specifications for Health Information Technology

Insection 170.200, we propose to remove term "EHR Modules" and add in its place "Health IT Modules." In section 170.210, we propose to remove the term "EHR technology" and add in its place "health IT." These proposals are consistent with our overall approach to this rulemaking as discussed in the Executive Summary.

Dated: March 18, 2015.

Sylvia M. Burwell,

Secretary.

Document incomplete, for more information click this link: https://www.federalregister.gov/articles/2015/03/30/2015-06612/2015-edition-health-information-technology-health-it-certification-criteria-2015-edition-base.

[*Federal RegisterVJ 2015-03-29]

Myron Struck, editor, Targeted News Service, Springfield, Va., 703/304-1897; editor@targetednews.com; http://www.targetednews.com

22VistaJ 150329-1198074



(c) 2015 Targeted News Service

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