ehr onc final certification - Department of Health Care Services

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Step 1 ($59.30/hr plus 21.35/hr for benefits) given the educational and professional experience we believe would be necessary to lead this type of activity. Multiplying the total hourly rate by the 2500 hours yields a total preparation cost of approximately $201,000. Thus, even if we were to assume that a high average for preparation of a Complete EHR or EHR Module would be double what the commenter stated, it would only represent close to $400,000 in preparation costs. Accordingly, we believe that our estimates are in fact comparatively high and the estimate range covers a wide range of possibilities. In the absence of additional data or any evidence to the contrary from public comment to guide revisions to our estimates, we are finalizing them according to the data and assumptions we identified in the Interim Final Rule. We believe that our estimates are sound, based on reasonable assumptions and data, and sufficiently accommodate varying costs for different types of Complete EHR and EHR Module developers. We believe that the additional clarity and specificity we have provided for some certification criteria and the removal of some required capabilities would further contribute to lowering the cost estimates for complying with this final rule. Consequently, we anticipate actual costs will fall somewhere between the low and mid-point ranges of our estimates rather than between the mid-point and high ranges of our estimates. Finally, with respect to the commenter who expressed concern regarding the total costs associated with developing a Complete EHR which had never been certified, we note that our estimates should not be construed to imply that a Complete EHR developer would have to spend over $1 million in order to prepare a Complete EHR. To the contrary, had we calculated our low range for preparing a Complete EHR based on the Page 192 of 228
absolute low we estimated for a per certification cost ($10,000), the total cost would have only been $240,000, or one-fifth the cost we estimated in the Interim Final Rule. The approach we took in the Interim Final Rule was designed to be inclusive of a middle range of possibilities, but was never meant to preclude the possibility that a Complete EHR developer could design a Complete EHR that was compliant with the certification criteria adopted by the Secretary for less than we estimated. Also in response to the commenter’s request, we do not believe that it would be appropriate, nor are we authorized, to provide subsidies to Complete EHR or EHR Module developers for the costs of the preparing a Complete EHR or EHR module for testing and certification. 2. Executive Order 12866 Final Analysis a. Costs This final rule adopts standards, implementation specifications, and certification criteria and consequently establishes the capabilities that Complete EHRs or EHR Modules will need to demonstrate in order to be certified. Our analysis focuses on the direct effects of the provisions of this final rule – the costs incurred by Complete EHR and EHR Module developers to prepare Complete EHRs and EHR Modules to be tested and certified in accordance with the certification criteria adopted by the Secretary. That is, we focus on the technological development costs necessary to include the capabilities in a Complete EHR or EHR Module that will be compliant with the certification criteria adopted by the Secretary. Again, as noted above, the actual cost a Complete EHR or EHR Module developer will incur to be tested and certified is accounted for in our certification programs final rules. Page 193 of 228
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DEPARTMENT OF HEALTH AND HUMAN SERV
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HHS Department of Health and Human
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5. Definition of Qualified EHR 6. D
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technology. Section 3004(b)(1) of t
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esolve identified technical challen
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Some commenters appear to have misi
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efficiencies and desired quality im
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codes must be used “inside” an
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not necessarily have applied to our
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3. Definition of Implementation Spe
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program established by the National
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criteria adopted by the Secretary a
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Comment. In the context of the defi
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y the certification criteria for a
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commenters asked whether we meant t
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adopted by the Secretary. The secon
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Response. We would like to make cle
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Response. In the Interim Final Rule
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could be a health care professional
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standard for certain purposes. In s
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e voluntary and would not be requir
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already existing regulatory require
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setting). We also include, where ap
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clarification on why the number of
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more clearly specify this capabilit
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Response. While we do not require t
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that check, the functionality show
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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
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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
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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
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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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Page 143 and 144: Comment. A commenter recommended th
Page 145 and 146: in accordance with one of the adopt
Page 147 and 148: Comments. Many commenters suggested
Page 149 and 150: flexibility in this certification c
Page 151 and 152: productive, confusing, time-consumi
Page 153 and 154: include in this initial set. Accord
Page 155 and 156: to the HITSP C32 implementation spe
Page 157 and 158: Response. Again, we do not believe
Page 159 and 160: e achieved without these and recomm
Page 161 and 162: electronically record, store, retri
Page 163 and 164: EHRs and EHR Modules designed for a
Page 165 and 166: §170.205(a)(2)(iii); and (v) The s
Page 167 and 168: Response. We disagree, as doing so
Page 169 and 170: Dental Terminology as a condition o
Page 171 and 172: However, we do not preclude Complet
Page 173 and 174: ability of CCD and CCR to support t
Page 175 and 176: ability to receive these reports. M
Page 177 and 178: commenters acknowledged and express
Page 179 and 180: a meaningful use objective they wou
Page 181 and 182: CMS and ONC had worked together to
Page 183 and 184: The eligible professional or eligib
Page 185 and 186: EHR technology with the needs of us
Page 187 and 188: The RFA requires agencies to analyz
Page 189 and 190: values seemed low and that the gap
Page 191: commenter provided), our assumption
Page 195 and 196: number of previously CCHIT-certifie
Page 197 and 198: for Certification Low High Page 197
Page 199 and 200: Finally, the third type of cost we
Page 201 and 202: 2012 15% $10.10 $30.80 $20.45 3-Yea
Page 203 and 204: The RFA requires agencies to analyz
Page 205 and 206: The Office of Management and Budget
Page 207 and 208: The standards and implementation sp
Page 209 and 210: The Secretary adopts the following
Page 211 and 212: any edition other than that specifi
Page 213 and 214: (e) Regenstrief Institute, Inc., LO
Page 215 and 216: 4. Revise subpart C to read as foll
Page 217 and 218: smoker; current some day smoker; fo
Page 219 and 220: (2) Generate audit log. Enable a us
Page 221 and 222: (3) Medication allergy list; (4) De
Page 223 and 224: §170.205(a)(1) or §170.205(a)(2).
Page 225 and 226: (d) Electronic copy of health infor
Page 227 and 228: specifications) specified in §170.
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