Department of health and human services
Medicare and Medicaid EHR Incentive Programs Rules
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- Bu səhifədəki naviqasiya:
- III. Provisions of the Proposed Rule affecting Standards, Implementation Specifications, and Certification Criteria
- Table 2. 2015 Edition Proposed Certification Criteria Associated with the EHR Incentive Programs Stage 3 Proposed CFR Citation
- Relationship to the Proposed CEHRT
2. Medicare and Medicaid EHR Incentive Programs RulesOn 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 § 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 § 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.
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