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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to respond to public comments received. Certification criteria and associated standards and implementation specifications will be used to test and certify Complete EHRs and EHR Modules in order to make it possible for eligible professionals and eligible hospitals to adopt and implement Certified EHR Technology. The use of Certified EHR Technology is one of the requirements an eligible professional or eligible hospital needs to meet in order to qualify for an incentive payment under the Medicare and Medicaid EHR Incentive Programs. C. Executive Order 12866 – Regulatory Planning and Review Analysis 1. Comment and Response Comments. A few commenters offered opinions related to the cost estimates included in the Interim Final Rule. One commenter disagreed with our approach. This commenter contended that our analysis followed a simplistic, linear model that did not account for the other potential costs that Complete EHR and EHR Module developers and health care providers would bear. The commenter suggested that we address other costs in our calculations including: whether a Complete EHR or EHR Module developer has adequate resources available to modify its HIT in order to prepare for certification; the loss of a Complete EHR or EHR Module developer’s net worth and dislocation of jobs if it fails and goes out of business; and the resulting impacts that would occur if a Complete EHR and EHR Module developer went out of business and left behind customers (some or many of which could then be ineligible for Medicare and Medicaid EHR Incentive Programs) with unsupported HIT. Another commenter questioned the cost estimates in the Interim Final Rule, but acknowledged that it was not prepared to offer alternative cost estimates. The commenter did state that it believed our dollar Page 188 of 228

values seemed low and that the gap of 25%, representing previously CCHIT-certified- EHRs that will need additional preparation to be tested and certified to the certification criteria adopted by the Secretary, also seemed low. The commenter suggested a 40-50% gap. The commenter also recommended that we revise our cost estimates based on the certification criteria in the final rule to: consider costs associated with workflow redesign within an eligible professional or eligible hospitals environment; factor in the costs for “interoperability implementation” (no further explanation was provided); account for the costs associated with implementing the clinical quality measures certification criterion; account for the costs for hardware capable of supporting the adopted security requirements; and factor in the costs for internal resources and customer resources. One commenter noted that the cost related to dentistry EHR technology may be higher due to what it perceived as a lack of commercially available EHR technology and that additional costs may be incurred by dentistry EHR developers that are not as familiar as EHR developers for other health providers with the certification criteria adopted by the Secretary. One commenter agreed with the $10,000 to $250,000 cost range we estimated for the per-certification-criterion preparation, while another commenter seemed to misinterpret this estimate as being the total cost to prepare a Complete EHR or EHR Module. This commenter offered that it could take over 2,500 hours to prepare a Complete EHR for certification. One commenter appeared to associate the costs related to the preparation of a Complete EHR to be tested and certified with the actual cost to be tested and certified, but nonetheless expressed concern that we had estimated that it would cost a Complete EHR developer whose EHR technology had not previously been certified no less than $1.2 million to become compliant with the Interim Final Rule’s Page 189 of 228

to respond to public comments received. Certification criteria and associated standards<br />

and implementation specifications will be used to test and certify Complete EHRs and<br />

EHR Modules in order to make it possible for eligible pr<strong>of</strong>essionals and eligible hospitals<br />

to adopt and implement Certified EHR Technology. The use <strong>of</strong> Certified EHR<br />

Technology is one <strong>of</strong> the requirements an eligible pr<strong>of</strong>essional or eligible hospital needs<br />

to meet in order to qualify for an incentive payment under the Medicare and Medicaid<br />

EHR Incentive Programs.<br />

C. Executive Order 12866 – Regulatory Planning and Review Analysis<br />

1. Comment and Response<br />

Comments. A few commenters <strong>of</strong>fered opinions related to the cost estimates<br />

included in the Interim Final Rule. One commenter disagreed with our approach. This<br />

commenter contended that our analysis followed a simplistic, linear model that did not<br />

account for the other potential costs that Complete EHR and EHR Module developers<br />

and health care providers would bear. The commenter suggested that we address other<br />

costs in our calculations including: whether a Complete EHR or EHR Module developer<br />

has adequate resources available to modify its HIT in order to prepare for <strong>certification</strong>;<br />

the loss <strong>of</strong> a Complete EHR or EHR Module developer’s net worth and dislocation <strong>of</strong><br />

jobs if it fails and goes out <strong>of</strong> business; and the resulting impacts that would occur if a<br />

Complete EHR and EHR Module developer went out <strong>of</strong> business and left behind<br />

customers (some or many <strong>of</strong> which could then be ineligible for Medicare and Medicaid<br />

EHR Incentive Programs) with unsupported HIT. Another commenter questioned the<br />

cost estimates in the Interim Final Rule, but acknowledged that it was not prepared to<br />

<strong>of</strong>fer alternative cost estimates. The commenter did state that it believed our dollar<br />

Page 188 <strong>of</strong> 228

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