ehr onc final certification - Department of Health Care Services

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to respond to public comments received. Certification criteria and associated standards and implementation specifications will be used to test and certify Complete EHRs and EHR Modules in order to make it possible for eligible professionals and eligible hospitals to adopt and implement Certified EHR Technology. The use of Certified EHR Technology is one of the requirements an eligible professional or eligible hospital needs to meet in order to qualify for an incentive payment under the Medicare and Medicaid EHR Incentive Programs. C. Executive Order 12866 – Regulatory Planning and Review Analysis 1. Comment and Response Comments. A few commenters offered opinions related to the cost estimates included in the Interim Final Rule. One commenter disagreed with our approach. This commenter contended that our analysis followed a simplistic, linear model that did not account for the other potential costs that Complete EHR and EHR Module developers and health care providers would bear. The commenter suggested that we address other costs in our calculations including: whether a Complete EHR or EHR Module developer has adequate resources available to modify its HIT in order to prepare for certification; the loss of a Complete EHR or EHR Module developer’s net worth and dislocation of jobs if it fails and goes out of business; and the resulting impacts that would occur if a Complete EHR and EHR Module developer went out of business and left behind customers (some or many of which could then be ineligible for Medicare and Medicaid EHR Incentive Programs) with unsupported HIT. Another commenter questioned the cost estimates in the Interim Final Rule, but acknowledged that it was not prepared to offer alternative cost estimates. The commenter did state that it believed our dollar Page 188 of 228
values seemed low and that the gap of 25%, representing previously CCHIT-certified- EHRs that will need additional preparation to be tested and certified to the certification criteria adopted by the Secretary, also seemed low. The commenter suggested a 40-50% gap. The commenter also recommended that we revise our cost estimates based on the certification criteria in the final rule to: consider costs associated with workflow redesign within an eligible professional or eligible hospitals environment; factor in the costs for “interoperability implementation” (no further explanation was provided); account for the costs associated with implementing the clinical quality measures certification criterion; account for the costs for hardware capable of supporting the adopted security requirements; and factor in the costs for internal resources and customer resources. One commenter noted that the cost related to dentistry EHR technology may be higher due to what it perceived as a lack of commercially available EHR technology and that additional costs may be incurred by dentistry EHR developers that are not as familiar as EHR developers for other health providers with the certification criteria adopted by the Secretary. One commenter agreed with the $10,000 to $250,000 cost range we estimated for the per-certification-criterion preparation, while another commenter seemed to misinterpret this estimate as being the total cost to prepare a Complete EHR or EHR Module. This commenter offered that it could take over 2,500 hours to prepare a Complete EHR for certification. One commenter appeared to associate the costs related to the preparation of a Complete EHR to be tested and certified with the actual cost to be tested and certified, but nonetheless expressed concern that we had estimated that it would cost a Complete EHR developer whose EHR technology had not previously been certified no less than $1.2 million to become compliant with the Interim Final Rule’s Page 189 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
Page 137 and 138: Send reminders to patients per pati
Page 139 and 140: specified data elements and CMS’s
Page 141 and 142: 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: The RFA requires agencies to analyz
Page 191 and 192: commenter provided), our assumption
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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ehr onc final certification - Department of Health Care Services

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