ehr onc final certification - Department of Health Care Services

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percentage calculations. They pointed out that the formulas CMS identified for many objectives would require providers to conduct labor-intensive counts of paper documents such as prescriptions or laboratory results in order to compute the denominators of the percentage based measures. Commenters also indicated that if Certified EHR Technology did not include this capability that it would dramatically increase the burden on potential meaningful users to demonstrate meaningful use and could potentially serve as a factor in their decision to participate in the Medicare and Medicaid EHR incentive programs. Response. We agree with commenters that unless we expressly adopt a certification criterion to specify that Certified EHR Technology must be capable of performing percentage-based calculations for meaningful use measures that it would present a significant burden to eligible professionals and eligible hospitals and could deter them from participating in the Medicare and Medicaid EHR incentives programs. Accordingly, we believe that it is critical to adopt the certification criterion specified above. We clarify that Certified EHR Technology must be capable of calculating all denominators for those meaningful use measures which are percentage-based and for which CMS requires an eligible professional or eligible hospital to submit the results at the end of an EHR reporting period. (CMS provides a detailed discussion in the Medicare and Medicaid EHR Incentive Programs final rule on denominators.) We note that as discussed in the Medicare and Medicaid EHR Incentive Programs final rule under the heading “Discussion of the Burden Created by the Measures associated with the Stage 1 Meaningful Use Objectives,” an eligible professional or eligible hospital is responsible for verifying that the denominator produced by Certified EHR Technology is complete. Page 182 of 228
The eligible professional or eligible hospital would be expected to know whether data had been incorrectly entered into Certified EHR Technology or whether all patient records were included in Certified EHR Technology. For Stage 1 meaningful use criteria, CMS identifies these measures in the table in its final rule with the headings: “Measures with a Denominator of Unique Patients Regardless of Whether the Patient’s Records Are Maintained Using Certified EHR Technology” and “Measures with a Denominator of Based on Counting Actions for Patients whose Records are Maintained Using Certified EHR Technology.” We do not require, as a condition of certification, that a Complete EHR or EHR Module provide results for the meaningful use measures that only require a “yes/no” attestation since these results should be readily apparent. These measures are also identified by CMS in the table in its final rule with the heading “Measures Requiring Only a Yes/No Attestation.” We do not believe that adoption of this certification criterion poses a significant technical challenge. Rather, we believe that this capability will provide Complete EHR and EHR Modules developers with a platform from which to innovate and compete regarding, for example, the EHR products’ ease of use. E. Additional Comments Comments. In response to our request for public comment, several commenters recommended that we adopt certification criteria requiring technical capabilities to provide greater access for people with disabilities. These commenters also pointed to a few standards currently being used to assure accessibility, including the Web Content Accessibility Guidelines (WCAG 2.0) and the Electronic and Information Technology Accessibility Standards. The commenters requested that we coordinate more with the Page 183 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
Page 131 and 132: was needed before RxNorm could be a
Page 133 and 134: • MDDB - Medi-Span Master Drug Da
Page 135 and 136: 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: CMS and ONC had worked together to
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 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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