ehr onc final certification - Department of Health Care Services

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Response. We clarify that we do not expect Certified EHR Technology to natively (or internally) support LOINC in its entirety, which is why we do not believe that it is necessary to specify a subset of common LOINC codes. Given the diverse comments and requests for clarification on this specific aspect of the certification criterion, we agree with commenters that we should not require a LOINC code that has been received, to then be displayed. Accordingly, we have decided to remove this requirement from the certification criterion. We do, however, wish to further clarify our current approach to Certified EHR Technology’s use of LOINC codes. Presently, we expect Certified EHR Technology to be able to reuse a LOINC code once it has been received and is accessible to Certified EHR Technology. We do not expect, as we mention above, that Certified EHR Technology will have to crosswalk or map internal or local codes to LOINC codes. This clarification is applicable to the standard that we have adopted regarding LOINC codes now specified at §170.207. This response is applicable to similar comments we received on other certification criteria that also referenced the use of LOINC codes. Finally, we agree with the commenter who suggested that we revise the heading of the standard at §170.205(a)(2)(iii). We have done this as part of the overall restructuring of the regulation text. Comments on 170.302(g)(3) Comments. Some commenters agreed with the capability specified in 170.302(g)(3). One noted a concern that modifications to either a certified Complete EHR or certified EHR Module could potentially result in the failure of Certified EHR Technology to display the test report information as required by the regulations and, thereby, put the laboratory in technical violation of the CLIA regulations. These Page 70 of 228
commenters reasoned that because a Complete EHR or EHR Module must be tested and certified to be in compliance with 42 CFR 493.1291(c)(1) through (7) that certification should replace any requirement for the laboratory to confirm that the information has been properly transmitted and meets the CLIA requirements. These commenters also asserted that a laboratory should be relieved of any further regulatory responsibility under 42 CFR 493.1291(c)(1) through (7) for the display of the required report information to the physician or subsequent viewers of the information if the Certified EHR Technology has been implemented by an eligible professional or eligible hospital. One commenter reiterated the point by stating that because Certified EHR Technology would be required to display the required CLIA report elements, laboratories should not be unfairly held accountable for any elements that may be removed or altered by other parties from the test report before received by the physician. Response. While we can understand the concern expressed by these commenters, we reiterate that the scope of our authority under this final rule only applies to capabilities that Certified EHR Technology must include. As a result, we cannot provide the regulatory relief that these commenters seek. Comments on 170.302(g)(4) Comments. A couple of commenters questioned whether we intended for the “updates” to be manual updates of electronic records. If that were true, some commenters were concerned that would create workflow problems and reduce the availability of results. Other commenters suggested that either the user be able to create an additional record, rather than be permitted to change the “official” record or that an adequate audit trail be preserved of the existing data and any updates, since an update Page 71 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
Page 19 and 20: 3. Definition of Implementation Spe
Page 21 and 22: program established by the National
Page 23 and 24: criteria adopted by the Secretary a
Page 25 and 26: Comment. In the context of the defi
Page 27 and 28: y the certification criteria for a
Page 29 and 30: commenters asked whether we meant t
Page 31 and 32: adopted by the Secretary. The secon
Page 33 and 34: Response. We would like to make cle
Page 35 and 36: Response. In the Interim Final Rule
Page 37 and 38: could be a health care professional
Page 39 and 40: standard for certain purposes. In s
Page 41 and 42: e voluntary and would not be requir
Page 43 and 44: already existing regulatory require
Page 45 and 46: setting). We also include, where ap
Page 47 and 48: clarification on why the number of
Page 49 and 50: more clearly specify this capabilit
Page 51 and 52: Response. While we do not require t
Page 53 and 54: that check, the functionality show
Page 55 and 56: Response. The comments are correct
Page 57 and 58: enable the user to electronically r
Page 59 and 60: longitudinal care, or whether the E
Page 61 and 62: EHR and EHR Module developers to pr
Page 63 and 64: suggestions for different age range
Page 65 and 66: Record smoking status for patients
Page 67 and 68: 23) during the EHR reporting period
Page 69: laboratory test results are receive
Page 73 and 74: laboratory test results to be elect
Page 75 and 76: or outreach Generate patient lists.
Page 77 and 78: months). We believe that these revi
Page 79 and 80: that the PQRI 2009 Registry XML spe
Page 81 and 82: To better align this certification
Page 83 and 84: the capability specified by the cer
Page 85 and 86: vendors were unwilling or unable to
Page 87 and 88: the concerns expressed by some comm
Page 89 and 90: Page 89 of 228 electronically compa
Page 91 and 92: (1) The standard (and applicable im
Page 93 and 94: for the purposes of demonstrating c
Page 95 and 96: Guide for Immunization Messaging Re
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
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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."
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Comment. A commenter recommended th
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in accordance with one of the adopt
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Comments. Many commenters suggested
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flexibility in this certification c
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productive, confusing, time-consumi
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include in this initial set. Accord
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to the HITSP C32 implementation spe
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Response. Again, we do not believe
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e achieved without these and recomm
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electronically record, store, retri
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EHRs and EHR Modules designed for a
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§170.205(a)(2)(iii); and (v) The s
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Response. We disagree, as doing so
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Dental Terminology as a condition o
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However, we do not preclude Complet
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ability of CCD and CCR to support t
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ability to receive these reports. M
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commenters acknowledged and express
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a meaningful use objective they wou
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CMS and ONC had worked together to
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The eligible professional or eligib
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EHR technology with the needs of us
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The RFA requires agencies to analyz
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values seemed low and that the gap
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commenter provided), our assumption
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absolute low we estimated for a per
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number of previously CCHIT-certifie
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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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