ehr onc final certification - Department of Health Care Services

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and further, that the Complete EHR or EHR Module developer would need to make sure this information is available and communicated to prospective purchasers as part of the Complete EHR or EHR Module’s certification. Complete EHRs and EHR Modules designed for an inpatient setting will be required to be tested and certified as being compliant with all of the clinical quality measures specified by CMS (Section II(A)(3) of the Medicare and Medicaid EHR Incentive Programs final rule) for eligible hospitals. Again, we believe this revision provides greater clarity and reduces the potential burden for Complete EHR and EHR Module developers. Comments. One commenter suggested that we separate the calculation and the submission parts of this certification criterion into two separate certification criteria. Response. We disagree. We see no basis for separating these two parts of this certification criterion into two separate certification criteria. However, we believe that it is necessary to specify two different certification criteria to account for the different clinical quality measures that eligible professionals and eligible hospitals will need to report. Accordingly, we have adopted separate certification criteria for Complete EHRs and EHR Modules designed for ambulatory and inpatient settings and referenced the respective quality measures for each in the appropriate certification criterion. Comments. One commenter suggested that all approved PQRI registries be automatically certified as an EHR Module. Response. We do not believe that it is prudent or appropriate to automatically deem certain HIT as certified. That being said, if a PQRI registry can adequately perform Page 82 of 228
the capability specified by the certification criterion, it could be certified as an EHR Module. Comments. Several commenters stated that Certified EHR Technology should be capable of collecting quality measurement data and calculating results for reporting to avoid having eligible professionals and eligible hospitals perform these processes manually. These commenters also stated that Certified EHR Technology should be capable of accurately and reliably reporting quality measurement data. Some commenters recommended that a Complete EHR or EHR Module only be required to be certified to existing e-measure specifications. Response. We agree that the collection of clinical quality measurement data and the calculation of results for submission to CMS should be performed by Certified EHR Technology. We also agree that Complete EHRs or EHR Modules should only be required to be tested and certified to developed electronic measure specifications. This is why CMS has only specified clinical quality measures for eligible professionals and eligible hospitals in the Medicare and Medicaid EHR Incentive Programs final rule for which electronic measure specifications have been developed. Complete EHR and EHR Module developers should follow these electronic measure specifications in order to accurately calculate clinical quality measures. Comments. Several commenters recommended that the certification criterion should be revised to include the word “accurately.” Response. We expect that clinical quality measures would be accurately calculated and do not see a need to specifically include the word in the certification criterion. Page 83 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
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 and 70: laboratory test results are receive
Page 71 and 72: commenters reasoned that because a
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: To better align this certification
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
Page 121 and 122: of the most secure encryption algor
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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
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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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ehr onc final certification - Department of Health Care Services

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