ehr onc final certification - Department of Health Care Services
ehr onc final certification - Department of Health Care Services ehr onc final certification - Department of Health Care Services
B. Why is this Rule Needed? C. Executive Order 12866 – Regulatory Planning and Review Analysis 1. Comment and Response 2. Executive Order 12866 Final Analysis a. Costs b. Benefits D. Regulatory Flexibility Act Analysis 1. Comment and Response 2. Final RFA Analysis E. Executive Order 13132 – Federalism Regulation Text I. Background A. Legislative History 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 (ARRA) (Pub. L. 111–5), was enacted on February 17, 2009. The HITECH Act amended the Public Health Service Act (PHSA) and established “Title XXX – Health Information Technology and Quality” to improve health care quality, safety, and efficiency through the promotion of health information technology (HIT) and the electronic exchange of health information. Section 3004(b)(1) of the PHSA requires the Secretary of Health and Human Services (the Secretary) to adopt an initial set of standards, implementation specifications, and certification criteria by December 31, 2009 to enhance the interoperability, functionality, utility, and security of health information Page 6 of 228
technology. Section 3004(b)(1) of the PHSA also permits the Secretary to adopt the initial set of standards, implementation specifications, and certification criteria on an interim, final basis. B. Regulatory History 1. Initial Set of Standards, Implementation Specifications, and Certification Criteria for EHR Technology Interim Final Rule On December 30, 2009, the Federal Register made available for public inspection, an interim final rule (the Interim Final Rule) with a request for comments, which adopted an initial set of standards, implementation specifications, and certification criteria. As noted in this rulemaking (75 FR 2014), we described how Congress fundamentally tied the adopted standards, implementation specifications, and certification criteria to the incentives available under the Medicare and Medicaid EHR Incentive Programs by requiring the meaningful use of Certified EHR Technology. Congress outlined several goals for meaningful use, one of which included the “use of certified EHR technology in a meaningful manner.” This means that to qualify for incentives, an eligible professional or eligible hospital must both adopt Certified EHR Technology and demonstrate meaningful use of this technology. The initial set of standards, implementation specifications, and certification criteria adopted in the Interim Final Rule established the capabilities that Certified EHR Technology would need to include to, at a minimum, support eligible professionals’ and eligible hospitals’ efforts to achieve what had been proposed for meaningful use Stage 1 under the Medicare and Medicaid EHR Incentive Programs proposed rule. Page 7 of 228
- Page 1 and 2: DEPARTMENT OF HEALTH AND HUMAN SERV
- Page 3 and 4: HHS Department of Health and Human
- Page 5: 5. Definition of Qualified EHR 6. D
- Page 9 and 10: esolve identified technical challen
- Page 11 and 12: Some commenters appear to have misi
- Page 13 and 14: efficiencies and desired quality im
- Page 15 and 16: codes must be used “inside” an
- Page 17 and 18: not necessarily have applied to our
- Page 19 and 20: 3. Definition of Implementation Spe
- Page 21 and 22: program established by the National
- Page 23 and 24: criteria adopted by the Secretary a
- Page 25 and 26: Comment. In the context of the defi
- Page 27 and 28: y the certification criteria for a
- Page 29 and 30: commenters asked whether we meant t
- Page 31 and 32: adopted by the Secretary. The secon
- Page 33 and 34: Response. We would like to make cle
- Page 35 and 36: Response. In the Interim Final Rule
- Page 37 and 38: could be a health care professional
- Page 39 and 40: standard for certain purposes. In s
- Page 41 and 42: e voluntary and would not be requir
- Page 43 and 44: already existing regulatory require
- Page 45 and 46: setting). We also include, where ap
- Page 47 and 48: clarification on why the number of
- Page 49 and 50: more clearly specify this capabilit
- Page 51 and 52: Response. While we do not require t
- Page 53 and 54: that check, the functionality show
- Page 55 and 56: Response. The comments are correct
technology. Section 3004(b)(1) <strong>of</strong> the PHSA also permits the Secretary to adopt the<br />
initial set <strong>of</strong> standards, implementation specifications, and <strong>certification</strong> criteria on an<br />
interim, <strong>final</strong> basis.<br />
B. Regulatory History<br />
1. Initial Set <strong>of</strong> Standards, Implementation Specifications, and Certification Criteria<br />
for EHR Technology Interim Final Rule<br />
On December 30, 2009, the Federal Register made available for public inspection,<br />
an interim <strong>final</strong> rule (the Interim Final Rule) with a request for comments, which adopted<br />
an initial set <strong>of</strong> standards, implementation specifications, and <strong>certification</strong> criteria. As<br />
noted in this rulemaking (75 FR 2014), we described how Congress fundamentally tied<br />
the adopted standards, implementation specifications, and <strong>certification</strong> criteria to the<br />
incentives available under the Medicare and Medicaid EHR Incentive Programs by<br />
requiring the meaningful use <strong>of</strong> Certified EHR Technology. Congress outlined several<br />
goals for meaningful use, one <strong>of</strong> which included the “use <strong>of</strong> certified EHR technology in<br />
a meaningful manner.” This means that to qualify for incentives, an eligible pr<strong>of</strong>essional<br />
or eligible hospital must both adopt Certified EHR Technology and demonstrate<br />
meaningful use <strong>of</strong> this technology.<br />
The initial set <strong>of</strong> standards, implementation specifications, and <strong>certification</strong><br />
criteria adopted in the Interim Final Rule established the capabilities that Certified EHR<br />
Technology would need to include to, at a minimum, support eligible pr<strong>of</strong>essionals’ and<br />
eligible hospitals’ efforts to achieve what had been proposed for meaningful use Stage 1<br />
under the Medicare and Medicaid EHR Incentive Programs proposed rule.<br />
Page 7 <strong>of</strong> 228