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

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equirements. The commenter requested that HHS provide assistance to EHR vendors with revenues of less than $1 million in order to help offset the costs of the certification process. Response. We appreciate commenters’ recommendations and suggestions related to our cost analysis. While we understand why some commenters recommended additional factors for us to consider as part of our analysis, we do not believe many of those factors are relevant for two primary reasons: 1) we believe that it is improbable that this rule will result in the outcomes speculated and their associated costs; and 2) the factors contributing to or causing the increased costs are outside the scope of this rule (e.g., hypothetical business failure and job loss, workflow redesign) and could not be reasonably or accurately estimated. In this regard, we reiterate what we stated in the Interim Final Rule related to how costs would be estimated. “This interim final rule estimates the costs commercial vendors, open source developers, and relevant Federal agencies will incur to prepare Complete EHRs and EHR Modules to be tested and certified to adopted standards, implementation specifications, and certification criteria. The Medicare and Medicaid EHR Incentive Programs proposed rule estimates the impacts related to the actions taken by eligible professionals or eligible hospitals to become meaningful users, including purchasing or self-developing Complete EHRs or EHR Modules. The HIT Certification Programs proposed rule estimates the testing and certification costs for Complete EHRs and EHR Modules.” Accordingly, we disagree with the commenter who contended that our estimates were too simplistic and linear. We believe that in the absence of any additional data or an alternative model (which no Page 190 of 228

commenter provided), our assumptions are sound and our analysis is reasonable for estimating the costs associated with complying with this final rule. We believe that it is important to note to commenters that compliance with this final rule is voluntary and as such, seeking to have a Complete EHR or EHR Module certified is voluntary. A Complete EHR or EHR Module developer is not required to comply with this final rule in order to operate its business. Rather, a Complete EHR or EHR Module developer will need to rely upon this final rule only if it ultimately seeks to have its EHR technology tested and certified as being compliant with the certification criteria adopted by the Secretary. Consequently, if a Complete EHR or EHR Module developer does not have the resources available to redesign its Complete EHR or EHR Module to incorporate the standards and implementation specifications or meet the certification criteria adopted in this rule, this rule does not create any new expenses for its business. Given this clarification, we believe that our estimates represent a higher than likely number of Complete EHR and EHR Module developers that will prepare their HIT to be tested and certified to the certification criteria adopted by the Secretary, and thus, the highest potential cost. We considered whether an hourly preparation cost should replace the assumptions we made in the Interim Final Rule, but found it difficult to determine what reasonable low and high hour ranges would be even if we were to assume 2500 hours to be the average. Further, for the purposes of testing this alternative approach, we assumed that it would be reasonable for the employees of a Complete EHR or EHR Module developer responsible for preparing a Complete EHR or EHR Module for testing and certification to be paid equivalent to a Federal employee with a Federal Salary Classification of GS-15 Page 191 of 228

equirements. The commenter requested that HHS provide assistance to EHR vendors<br />

with revenues <strong>of</strong> less than $1 million in order to help <strong>of</strong>fset the costs <strong>of</strong> the <strong>certification</strong><br />

process.<br />

Response. We appreciate commenters’ recommendations and suggestions related<br />

to our cost analysis. While we understand why some commenters recommended<br />

additional factors for us to consider as part <strong>of</strong> our analysis, we do not believe many <strong>of</strong><br />

those factors are relevant for two primary reasons: 1) we believe that it is improbable that<br />

this rule will result in the outcomes speculated and their associated costs; and 2) the<br />

factors contributing to or causing the increased costs are outside the scope <strong>of</strong> this rule<br />

(e.g., hypothetical business failure and job loss, workflow redesign) and could not be<br />

reasonably or accurately estimated. In this regard, we reiterate what we stated in the<br />

Interim Final Rule related to how costs would be estimated. “This interim <strong>final</strong> rule<br />

estimates the costs commercial vendors, open source developers, and relevant Federal<br />

agencies will incur to prepare Complete EHRs and EHR Modules to be tested and<br />

certified to adopted standards, implementation specifications, and <strong>certification</strong> criteria.<br />

The Medicare and Medicaid EHR Incentive Programs proposed rule estimates the<br />

impacts related to the actions taken by eligible pr<strong>of</strong>essionals or eligible hospitals to<br />

become meaningful users, including purchasing or self-developing Complete EHRs or<br />

EHR Modules. The HIT Certification Programs proposed rule estimates the testing and<br />

<strong>certification</strong> costs for Complete EHRs and EHR Modules.” Accordingly, we disagree<br />

with the commenter who contended that our estimates were too simplistic and linear. We<br />

believe that in the absence <strong>of</strong> any additional data or an alternative model (which no<br />

Page 190 <strong>of</strong> 228

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