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54163 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 170

RIN 0991–AB82

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

AGENCY: Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services. ACTION: Final rule.

SUMMARY: With this final rule, the Secretary of Health and Human Services adopts certification criteria that establish the technical capabilities and specify the related standards and implementation specifications that Certified Electronic Health Record (EHR) Technology will need to include to, at a minimum, support the achievement of meaningful use by eligible professionals, eligible hospitals, and critical access hospitals under the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in fiscal year and calendar year 2014. This final rule also makes changes to the permanent certification program for health information technology, including changing the program’s name to the ONC HIT Certification Program. DATES: These regulations are effective October 4, 2012. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of October 4, 2012. FOR FURTHER INFORMATION CONTACT: Steven Posnack, Director, Federal Policy Division, Office of Policy and Planning, Office of the National Coordinator for Health Information Technology, 202– 690–7151. SUPPLEMENTARY INFORMATION: This final rule is issued under section 3004 of the Public Health Service Act.

Commonly Used Acronyms

CAH Critical Access Hospital CDA Clinical Document Architecture CDC Centers for Disease Control and

Prevention CDS Clinical Decision Support CEHRT Certified EHR Technology CFR Code of Federal Regulations CHPL Certified HIT Products List CMS Centers for Medicare & Medicaid

Services

CQM Clinical Quality Measure CY Calendar Year EH Eligible Hospital EHR Electronic Health Record EP Eligible Professional FY Fiscal Year HHS Department of Health and Human

Services HIPAA Health Insurance Portability and

Accountability Act of 1996 HIT Health Information Technology HITECH Health Information Technology for

Economic and Clinical Health HITPC HIT Policy Committee HITSC HIT Standards Committee HL7 Health Level Seven ICD–9–CM International Classification of

Diseases, 9th Revision, Clinical Modification

ICD–10 International Classification of Diseases, 10th Revision

ICD–10–CM International Classification of Diseases, 10th Revision, Clinical Modification

ICD–10–PCS International Classification of Diseases, 10th Revision, Procedure Coding System

IHE Integrating the Healthcare Enterprise® LOINC® Logical Observation Identifiers

Names and Codes MU Meaningful Use ONC Office of the National Coordinator of

Health Information Technology NCPDP National Council for Prescription

Drug Programs NIST National Institute of Standards and

Technology PHSA Public Health Service Act SNOMED CT® Systematized Nomenclature

of Medicine Clinical Terms I. Executive Summary

A. Purpose of Regulatory Action B. Summary of Major Provisions 1. Overview of the 2014 Edition EHR

Certification Criteria 2. Certified EHR Technology 3. ONC HIT Certification Program C. Costs and Benefits

II. Background A. Statutory Basis 1. Standards, Implementation

Specifications, and Certification Criteria 2. HIT Certification Programs B. Regulatory History 1. Standards, Implementation

Specifications, and Certification Criteria Rules

2. Medicare and Medicaid EHR Incentive Programs Rules

3. HIT Certification Programs Rules III. Provisions of the Final Rule Affecting

Standards, Implementation Specifications and Certification Criteria

A. 2014 Edition EHR Certification Criteria 1. Certification Criteria Relationship to MU 2. Applicability 3. Scope of a Certification Criterion for

Certification 4. Explanation and Revision of Terms Used

in Certification Criteria 5. Consensus-Based Standards 6. Adopting Versions of Standards 7. Display of Vocabulary Standards 8. Common Data Elements in Certification

Criteria 9. New Certification Criteria

a. Ambulatory and Inpatient Setting b. Ambulatory Setting c. Inpatient Setting 10. Revised Certification Criteria a. Ambulatory and Inpatient Setting b. Ambulatory Setting c. Inpatient Setting 11. Unchanged Certification Criteria a. Refinements to Unchanged Certification

Criteria b. Unchanged Certification Criteria

Without Refinements 12. Gap Certification 13. ‘‘Disability’’ Status B. Redefining Certified EHR Technology

and Related Terms 1. Certified EHR Technology (CEHRT)

Definition 2. Base EHR Definition 3. Complete EHR Definition 4. Certifications Issued for Complete EHRs

and EHR Modules 5. Adaptations of Certified Complete EHRs

or Certified EHR Modules IV. Provisions of the Final Rule Affecting the

Permanent Certification Program for HIT (‘‘ONC HIT Certification Program’’)

A. Program Name Change B. ‘‘Minimum Standards’’ Code Sets C. Revisions to EHR Module Certification

Requirements 1. Privacy and Security Certification 2. Certification to Certain New Certification

Criteria D. ONC–ACB Reporting Requirements E. Continuation and Representation of

Certified Status 1. 2011 or 2014 Edition EHR Certification

Criteria Compliant 2. Updating a Certification 3. Representation of Meeting the Base EHR

Definition F. EHR Technology Price Transparency G. Certification and Certification Criteria

for Other Health Care Settings V. Collection of Information Requirements VI. Regulatory Impact Statement

A. Statement of Need B. Overall Impact 1. Comment and Response 2. Executive Orders 12866 and 13563—

Regulatory Planning and Review Analysis

a. Costs i. Development and Preparation Costs for

2014 Edition EHR Certification Criteria ii. Overall Development and Preparation

Estimated Costs Over a 3-Year Period iii. Costs for Reporting Test Results

Hyperlinks b. Benefits 3. Regulatory Flexibility Act Analysis 4. Executive Order 13132—Federalism 5. Unfunded Mandates Reform Act of 1995

Regulation Text

I. Executive Summary

A. Purpose of Regulatory Action 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

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54164 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations

October 21, 2011. In fulfilling his duties under sections 3001(c)(1)(A) and (B) of the Public Health Service Act (PHSA), the National Coordinator reviewed the recommendations made by the HITSC, endorsed certain standards, implementation specifications, and certification criteria, and reported his determinations to the Secretary for consideration. On March 7, 2012, the Secretary published a proposed rule (77 FR 13832) with her determinations regarding the standards, implementation specifications, and certification criteria endorsed by the National Coordinator, as required by section 3004(a)(3) of the PHSA. The proposed rule solicited public comment on the standards, implementation specifications, and certification criteria the Secretary proposed for adoption.

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.

B. Summary of Major Provisions

1. Overview of the 2014 Edition EHR Certification Criteria

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. T