ehr onc final certification - Department of Health Care Services

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As we noted in the Interim Final Rule, we analyzed previously developed CCHIT ambulatory and inpatient certification criteria and believe that many of those criteria, but not all, require the exact same capabilities as the certification criteria adopted by the Secretary at 45 CFR 170.302, 45 CFR 170.304, and 45 CFR 170.306. Generally speaking, we believe this overlap includes most of the clinically oriented capabilities required by the certification criteria adopted by the Secretary. Accordingly, we believe that a significant number of previously CCHIT-certified-EHRs will only incur moderate costs to prepare for certification. For the purpose of estimating costs, we presume that previously CCHIT-certified-EHRs include the functionality to meet the definition of a Complete EHR. As a result, for our estimates in Table 1, we anticipate that these previously CCHIT-certified-EHRs will again be prepared for certification as Complete EHRs. We estimated in the Interim Final Rule that there were 74 CCHIT-certified-EHRs certified to its 2008 ambulatory certification criteria and 17 CCHIT-certified-EHRs certified to its 2007 or 2008 inpatient certification criteria. 11,12,13 Of these 74 and 17 previously CCHIT-certified-EHRs, we expect that 90% will be prepared and submitted for certification according to the certification criteria adopted by the Secretary. We do not believe that it is realistic to assume that 100% of previously CCHIT-certified-EHRs will be prepared for certification for a number of reasons. These reasons include: 1) a recognition that mergers and acquisitions within the marketplace have reduced the 11 Some are marked with a conditional certification either “Pre-Market: These are conditionally certified EHRs which are new products that are fully certified once their operational use at a physician office site has been verified.” or “eRx Conditional: These are conditionally certified pending advanced ePrescribing EHRs that are in the process of verifying their ability to conduct medication history, formulary and eligibility checking through a national network for electronic-prescribing transactions.” We do not believe that these caveats have any discernible effect on our estimates. 12 http://www.cchit.org/products/Ambulatory -- when certification years 2006 and 2007 are unchecked. While 78 EHRs are now listed, we do not believe that changing our estimate would have a measureable effect on the overall costs. 13 http://www.cchit.org/products/Inpatient Page 194 of 228
number of previously CCHIT-certified-EHRs; 2) that the subsequent resources needed to market and promote Certified EHR Technology may not be available at the present time; and 3) that some previously CCHIT-certified-EHRs will be tested and certified as EHR Modules rather than Complete EHRs. Given these assumptions, we have estimated the number of previously CCHIT-certified-EHRs that will be prepared to be tested and certified will be 65 and 15, ambulatory and inpatient, respectively. We also believe it is reasonable to assume that of these 65 and 15, some will require more preparation than others (i.e., we assume that some EHRs that were previously CCHIT-certified will include more capabilities than what they had when CCHIT originally tested and certified them, and they may consequently be able to more easily meet the certification criteria adopted by the Secretary). Based on this assumption, we have created low and high ranges for the costs to prepare previously CCHIT-certified ambulatory and inpatient EHRs. In creating our low and high ranges for the tables below, we assumed based on our analysis of previously developed and required CCHIT certification criteria that certain capabilities (e.g., the capability to maintain a medication list) will have been widely implemented and deployed in HIT so that there will be little or no need to modify Complete EHRs or EHR Modules for certification. We also assumed that the certification criteria adopted by the Secretary range from relatively simple capabilities (e.g., recording a patient’s smoking status) to more sophisticated capabilities (e.g., clinical decision support). As a result, we have made a general assumption that the costs to prepare Complete EHRs and EHR Modules to be tested and certified will vary depending on a number of factors including, but not limited to, whether the Complete Page 195 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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what would qualify as a "response."
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 and 192: commenter provided), our assumption
Page 193: absolute low we estimated for a per
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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ehr onc final certification - Department of Health Care Services

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