ehr onc final certification - Department of Health Care Services
ehr onc final certification - Department of Health Care Services ehr onc final certification - Department of Health Care Services
Along these same lines, another commenter recommended that EHR technology should be tested and certified only to the clinical quality measures applicable to the medical specialties of the eligible professionals that the EHR technology is intended to support and to whom it is marketed. Other commenters expressed concerns about timing and that a significant amount of effort would be required to reprogram Complete EHRs and EHR Modules to capture, calculate, and report the final meaningful use Stage 1 measures. Many commenters also stated that the proposed quality measures are not yet ready for automated reporting, that a significant amount of work is still required by the measure developer community, and that the value sets for these quality measures have not been validated. Several commenters objected to the reference to “States” in the certification criterion and recommended that it be removed. These commenters contended that the certification criterion should be limited to the “federal requirements” and further that it was unrealistic to expect Complete EHR and EHR Module developers to also comply with 50 separate State requirements as a condition of certification. Response. We understand that CMS has worked to significantly increase the availability of a number of electronic measure specifications that are associated with specific clinical quality measures. In light of the final approach CMS has taken with respect to clinical quality measures for meaningful use Stage 1, we have revised this certification to better align it with the Medicare and Medicaid EHR Incentive Programs final rule requirements. We also agree with those commenters that requested we explicitly focus the report of clinical quality measures certification criterion, and the certification criteria in general, on Federal requirements and have removed the reference to “or States” in this certification criterion. Page 80 of 228
To better align this certification criterion with the final approach to clinical quality measures in the Medicare and Medicaid EHR Incentive Programs final rule, we have determined that it is no longer sufficient to specify one general certification criterion for both Complete EHRs and EHR Modules designed for either an ambulatory or inpatient setting. Accordingly, the final rule in §§170.304 and 170.306 will include a specific certification criterion for each setting. Complete EHRs and EHR Modules designed for an ambulatory setting will be required to be tested and certified as being compliant with all 6 of the core (3 core and 3 alternate core) clinical quality measures specified by CMS for eligible professionals (Section II(A)(3) of the Medicare and Medicaid EHR Incentive Programs final rule). Complete EHRs and EHR Modules designed for an ambulatory setting will also be required to be tested and certified as being compliant with, at a minimum, 3 of the additional clinical quality measures CMS has identified for eligible professionals (Section II(A)(3)of the Medicare and Medicaid EHR Incentive Programs final rule). We believe this revision provides clarity and flexibility and reduces the potential burden for Complete EHR and EHR Module developers (who may have been unfamiliar with certain clinical quality measures because of the type of eligible professional they serve) to become compliant with this certification criterion. As a result, Complete EHR and EHR Module developers for the ambulatory setting may provide Certified EHR Technology with a certain level of variability in terms of clinical quality measure capabilities. To provide further transparency for potential eligible professionals regarding the clinical quality measures to which a Complete EHR or EHR Module has been tested and certified, we specified that an ONC-Authorized Testing and Certification Body would need to report such information to the National Coordinator, Page 81 of 228
- 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 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: that the PQRI 2009 Registry XML spe
- 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
- 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
To better align this <strong>certification</strong> criterion with the <strong>final</strong> approach to clinical<br />
quality measures in the Medicare and Medicaid EHR Incentive Programs <strong>final</strong> rule, we<br />
have determined that it is no longer sufficient to specify one general <strong>certification</strong> criterion<br />
for both Complete EHRs and EHR Modules designed for either an ambulatory or<br />
inpatient setting. Accordingly, the <strong>final</strong> rule in §§170.304 and 170.306 will include a<br />
specific <strong>certification</strong> criterion for each setting. Complete EHRs and EHR Modules<br />
designed for an ambulatory setting will be required to be tested and certified as being<br />
compliant with all 6 <strong>of</strong> the core (3 core and 3 alternate core) clinical quality measures<br />
specified by CMS for eligible pr<strong>of</strong>essionals (Section II(A)(3) <strong>of</strong> the Medicare and<br />
Medicaid EHR Incentive Programs <strong>final</strong> rule). Complete EHRs and EHR Modules<br />
designed for an ambulatory setting will also be required to be tested and certified as being<br />
compliant with, at a minimum, 3 <strong>of</strong> the additional clinical quality measures CMS has<br />
identified for eligible pr<strong>of</strong>essionals (Section II(A)(3)<strong>of</strong> the Medicare and Medicaid EHR<br />
Incentive Programs <strong>final</strong> rule). We believe this revision provides clarity and flexibility<br />
and reduces the potential burden for Complete EHR and EHR Module developers (who<br />
may have been unfamiliar with certain clinical quality measures because <strong>of</strong> the type <strong>of</strong><br />
eligible pr<strong>of</strong>essional they serve) to become compliant with this <strong>certification</strong> criterion. As<br />
a result, Complete EHR and EHR Module developers for the ambulatory setting may<br />
provide Certified EHR Technology with a certain level <strong>of</strong> variability in terms <strong>of</strong> clinical<br />
quality measure capabilities. To provide further transparency for potential eligible<br />
pr<strong>of</strong>essionals regarding the clinical quality measures to which a Complete EHR or EHR<br />
Module has been tested and certified, we specified that an ONC-Authorized Testing and<br />
Certification Body would need to report such information to the National Coordinator,<br />
Page 81 <strong>of</strong> 228
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