ehr onc final certification - Department of Health Care Services

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Comment. A commenter requested clarification on the use of the word “and” in the certification criterion and questioned whether it suggested that the Certified EHR Technology must generate two outputs to produce an electronic copy (i.e., a copy in human readable format and a copy as a CCD or CCR). The commenter made this inquiry because it believed that the certification criterion could be met through the production of a CCD or CCR with an appropriate style sheet. Additionally, a commenter stated that it is unclear whether the electronic copy of the health information provided to patients must be in a CCD or CCR format for Stage 1 or if alternative formats are allowed. This commenter recommended that we clarify and distinguish between the electronic medium carrying the information and the content enclosed. Response. Yes, in order to meet this certification criterion, Certified EHR Technology must be able to generate an electronic copy that is in human readable format and as a CCD or CCR. If Certified EHR Technology is capable of generating one copy that could meet both of these requirements, we would consider that to be a compliant implementation of this capability. §170.304(g) - Timely access Meaningful Use Stage 1 Objective Provide patients with timely electronic access to their health information (including lab results, problem list, medication lists, medication allergies) within four business days of the information being available to the EP Meaningful Use Stage 1 Measure More than 10% of all unique patients seen by the EP are provided timely (available to the patient within four business days of being updated in the certified EHR technology) electronic access to their health information subject to the EP’s discretion to withhold certain information Page 146 of 228 Certification Criterion Interim Final Rule Text: Enable a user to provide patients with online access to their clinical information, including, at a minimum, lab test results, problem list, medication list, medication allergy list, immunizations, and procedures. Final Rule Text: §170.304(g) Timely access. Enable a user to provide patients with online access to their clinical information, including, at a minimum, lab test results, problem list, medication list, and medication allergy list.
Comments. Many commenters suggested that we should replace the word “online” with “electronic” to be more clearly aligned with meaningful use and to not preclude other forms of legitimate electronic access. Response. We disagree. The purpose and intent of this certification criterion and its associated meaningful use objective and measure (as clarified in the Medicare and Medicaid EHR Incentive Programs final rule) is to ensure that patients have the ability to access their health information when they see fit to do so. Accordingly, referring to “electronic” in this certification criterion would not ensure that Certified EHR Technology provides the desired capability. Comments. A few commenters asked for clarification on the meaning of “procedures” and type of results to be listed in the electronic copy, for example, lab test results, problem list, medication lists, or others specified by the eligible professional. Response. As discussed above, we have revised this certification criterion to remove “procedures” as well as “immunizations,” to be more consistent with the final meaningful use objective and measure. §170.304(h) - Clinical summaries Meaningful Use Stage 1 Objective Provide clinical summaries for patients for each office visit Meaningful Use Stage 1 Measure Clinical summaries provided to patients for more than 50% of all office visits within 3 business days Page 147 of 228 Certification Criterion Interim Final Rule Text: (1) Provision. Enable a user to provide clinical summaries to patients for each office visit that include, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, immunizations and procedures. (2) Provided electronically. If the clinical summary is provided electronically it must be: (i) Provided in human readable format; and (ii) On electronic media or through some other electronic means in accordance with: (A) One of the standards specified in §170.205(a)(1); (B) The standard specified in §170.205(a)(2)(i)(A), or, at a minimum, the version of the standard specified in §170.205(a)(2)(i)(B);
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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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Page 97 and 98: Response. We clarify for commenters
Page 99 and 100: serve as a limiting factor, however
Page 101 and 102: Page 101 of 228 Unchanged Comment.
Page 103 and 104: Comment. One commenter suggested th
Page 105 and 106: Response. We appreciate the thought
Page 107 and 108: Complete EHRs or EHR Modules design
Page 109 and 110: Response. We disagree. As stated ab
Page 111 and 112: Response. As discussed above, we ha
Page 113 and 114: SHA-1 and other secure hash algorit
Page 115 and 116: misinterpreted our example and stat
Page 117 and 118: Other commenters also expressed con
Page 119 and 120: eferenced in FIPS 140-2 Annex A, wh
Page 121 and 122: of the most secure encryption algor
Page 123 and 124: the disclosure was made (recipient)
Page 125 and 126: Use CPOE for medication orders dire
Page 127 and 128: equire EHRs to build custom interfa
Page 129 and 130: 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: in accordance with one of the adopt
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
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for Certification Low High Page 197
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Finally, the third type of cost we
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2012 15% $10.10 $30.80 $20.45 3-Yea
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The RFA requires agencies to analyz
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The Office of Management and Budget
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The standards and implementation sp
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The Secretary adopts the following
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any edition other than that specifi
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(e) Regenstrief Institute, Inc., LO
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4. Revise subpart C to read as foll
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smoker; current some day smoker; fo
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(2) Generate audit log. Enable a us
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(3) Medication allergy list; (4) De
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§170.205(a)(1) or §170.205(a)(2).
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(d) Electronic copy of health infor
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specifications) specified in §170.
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