ehr onc final certification - Department of Health Care Services

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equirements. The commenter requested that HHS provide assistance to EHR vendors with revenues of less than $1 million in order to help offset the costs of the certification process. Response. We appreciate commenters’ recommendations and suggestions related to our cost analysis. While we understand why some commenters recommended additional factors for us to consider as part of our analysis, we do not believe many of those factors are relevant for two primary reasons: 1) we believe that it is improbable that this rule will result in the outcomes speculated and their associated costs; and 2) the factors contributing to or causing the increased costs are outside the scope of this rule (e.g., hypothetical business failure and job loss, workflow redesign) and could not be reasonably or accurately estimated. In this regard, we reiterate what we stated in the Interim Final Rule related to how costs would be estimated. “This interim final rule estimates the costs commercial vendors, open source developers, and relevant Federal agencies will incur to prepare Complete EHRs and EHR Modules to be tested and certified to adopted standards, implementation specifications, and certification criteria. The Medicare and Medicaid EHR Incentive Programs proposed rule estimates the impacts related to the actions taken by eligible professionals or eligible hospitals to become meaningful users, including purchasing or self-developing Complete EHRs or EHR Modules. The HIT Certification Programs proposed rule estimates the testing and certification costs for Complete EHRs and EHR Modules.” Accordingly, we disagree with the commenter who contended that our estimates were too simplistic and linear. We believe that in the absence of any additional data or an alternative model (which no Page 190 of 228
commenter provided), our assumptions are sound and our analysis is reasonable for estimating the costs associated with complying with this final rule. We believe that it is important to note to commenters that compliance with this final rule is voluntary and as such, seeking to have a Complete EHR or EHR Module certified is voluntary. A Complete EHR or EHR Module developer is not required to comply with this final rule in order to operate its business. Rather, a Complete EHR or EHR Module developer will need to rely upon this final rule only if it ultimately seeks to have its EHR technology tested and certified as being compliant with the certification criteria adopted by the Secretary. Consequently, if a Complete EHR or EHR Module developer does not have the resources available to redesign its Complete EHR or EHR Module to incorporate the standards and implementation specifications or meet the certification criteria adopted in this rule, this rule does not create any new expenses for its business. Given this clarification, we believe that our estimates represent a higher than likely number of Complete EHR and EHR Module developers that will prepare their HIT to be tested and certified to the certification criteria adopted by the Secretary, and thus, the highest potential cost. We considered whether an hourly preparation cost should replace the assumptions we made in the Interim Final Rule, but found it difficult to determine what reasonable low and high hour ranges would be even if we were to assume 2500 hours to be the average. Further, for the purposes of testing this alternative approach, we assumed that it would be reasonable for the employees of a Complete EHR or EHR Module developer responsible for preparing a Complete EHR or EHR Module for testing and certification to be paid equivalent to a Federal employee with a Federal Salary Classification of GS-15 Page 191 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
Page 139 and 140: 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: values seemed low and that the gap
Page 193 and 194: absolute low we estimated for a per
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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