ehr onc final certification - Department of Health Care Services

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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
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enable the user to electronically r
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longitudinal care, or whether the E
Page 61 and 62:
EHR and EHR Module developers to pr
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suggestions for different age range
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Record smoking status for patients
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23) during the EHR reporting period
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laboratory test results are receive
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commenters reasoned that because a
Page 73 and 74:
laboratory test results to be elect
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or outreach Generate patient lists.
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months). We believe that these revi
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that the PQRI 2009 Registry XML spe
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To better align this certification
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the capability specified by the cer
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vendors were unwilling or unable to
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the concerns expressed by some comm
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Page 89 of 228 electronically compa
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(1) The standard (and applicable im
Page 93 and 94:
for the purposes of demonstrating c
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Guide for Immunization Messaging Re
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Response. We clarify for commenters
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serve as a limiting factor, however
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Page 101 of 228 Unchanged Comment.
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Comment. One commenter suggested th
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Response. We appreciate the thought
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Complete EHRs or EHR Modules design
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Response. We disagree. As stated ab
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Response. As discussed above, we ha
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SHA-1 and other secure hash algorit
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misinterpreted our example and stat
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Other commenters also expressed con
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eferenced in FIPS 140-2 Annex A, wh
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of the most secure encryption algor
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the disclosure was made (recipient)
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Use CPOE for medication orders dire
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equire EHRs to build custom interfa
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esult, we do not believe that this
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was needed before RxNorm could be a
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• MDDB - Medi-Span Master Drug Da
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Response. We do not believe that it
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Send reminders to patients per pati
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specified data elements and CMS’s
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what would qualify as a "response."
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Comment. A commenter recommended th
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in accordance with one of the adopt
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Comments. Many commenters suggested
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flexibility in this certification c
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productive, confusing, time-consumi
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include in this initial set. Accord
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to the HITSP C32 implementation spe
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Response. Again, we do not believe
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e achieved without these and recomm
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electronically record, store, retri
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EHRs and EHR Modules designed for a
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§170.205(a)(2)(iii); and (v) The s
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Response. We disagree, as doing so
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Dental Terminology as a condition o
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However, we do not preclude Complet
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ability of CCD and CCR to support t
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ability to receive these reports. M
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commenters acknowledged and express
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a meaningful use objective they wou
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CMS and ONC had worked together to
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The eligible professional or eligib
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EHR technology with the needs of us
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The RFA requires agencies to analyz
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values seemed low and that the gap
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commenter provided), our assumption
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absolute low we estimated for a per
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number of previously CCHIT-certifie
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for Certification Low High Page 197
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Finally, the third type of cost we
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2012 15% $10.10 $30.80 $20.45 3-Yea
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The RFA requires agencies to analyz
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The Office of Management and Budget
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The standards and implementation sp
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The Secretary adopts the following
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any edition other than that specifi
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(e) Regenstrief Institute, Inc., LO
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4. Revise subpart C to read as foll
Page 217 and 218:
smoker; current some day smoker; fo
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(2) Generate audit log. Enable a us
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(3) Medication allergy list; (4) De
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§170.205(a)(1) or §170.205(a)(2).
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(d) Electronic copy of health infor
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specifications) specified in §170.
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