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
D. Regulatory Flexibility Act Analysis 1. Comment and Response Comment. Some commenters noted that we incorrectly referenced the proportion of businesses in the marketplace that would qualify as small businesses under the SBA’s size standard. The commenters cited a presentation by CCHIT which indicated that potentially up to 75% of Complete EHR developers who design Complete EHRs for ambulatory settings would qualify as small businesses. Response. We appreciate commenters pointing out this additional information. We have revised the discussion accordingly in the final RFA analysis. However, we do not believe that this additional information substantially changes our analysis. We do not believe that any relief can be provided to small businesses under the SBA size standard that would not undercut our programmatic goals and objectives. A Complete EHR or EHR Module developer will need to design a Complete EHR or EHR Module that can be tested and successfully certified to all applicable certification criteria adopted by the Secretary in order for the Complete EHR or EHR Module to attain certification. Accordingly, we see no viable alternatives to reducing the requirements in the final rule or providing for alternatives to adopted certification criteria. Additionally, we believe that the regulation builds in a certain amount of flexibility already in that a small business without the resources available to develop a Complete EHR has the option to develop an EHR Module which will presumably require less of an investment (time and money) to develop. 2. Final RFA Analysis Page 202 of 228
The RFA requires agencies to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. While Complete EHRs and EHR Module developers represent a small segment of the overall information technology industry, we believe that the entities impacted by this final rule most likely fall under the North American Industry Classification System (NAICS) code 541511 “Custom Computer Programming Services” specified at 13 CFR 121.201 where the SBA publishes “Small Business Size Standards by NAICS Industry.” The size standard associated with this NAICS code is set at $25 million in annual receipts 17 which “indicates the maximum allowed for a concern and its affiliates to be considered small entities.” Based on our analysis, we believe that there is enough data generally available to establish that between 75% and 90% of entities that are categorized under the NAICS code 541511 are under the SBA size standard, but note that the available data does not show how many of these entities will develop a Complete EHR or EHR Module. We also note that with the exception of aggregate business information available through the U.S. Census Bureau and the SBA related to NAICS code 541511, it appears that many Complete EHR and EHR Module developers are privately held or owned and do not regularly, if at all, make their specific annual receipts publicly available. As a result, it is difficult to locate empirical data related to many of the Complete EHR and EHR Module developers to correlate to the SBA size standard. 17 The SBA references that annual receipts means “total income” (or in the case of a sole proprietorship, “gross income”) plus “cost of goods sold” as these terms are defined and reported on Internal Revenue Service tax return forms. http://www.sba.gov/idc/groups/public/documents/sba_homepage/guide_to_size_standards.pdf Page 203 of 228
- Page 151 and 152: productive, confusing, time-consumi
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- Page 167 and 168: Response. We disagree, as doing so
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- Page 175 and 176: ability to receive these reports. M
- Page 177 and 178: commenters acknowledged and express
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- Page 201: 2012 15% $10.10 $30.80 $20.45 3-Yea
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- Page 217 and 218: smoker; current some day smoker; fo
- Page 219 and 220: (2) Generate audit log. Enable a us
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- Page 223 and 224: §170.205(a)(1) or §170.205(a)(2).
- Page 225 and 226: (d) Electronic copy of health infor
- Page 227 and 228: specifications) specified in §170.
The RFA requires agencies to analyze options for regulatory relief <strong>of</strong> small<br />
businesses if a rule has a significant impact on a substantial number <strong>of</strong> small entities.<br />
While Complete EHRs and EHR Module developers represent a small segment <strong>of</strong><br />
the overall information technology industry, we believe that the entities impacted by this<br />
<strong>final</strong> rule most likely fall under the North American Industry Classification System<br />
(NAICS) code 541511 “Custom Computer Programming <strong>Services</strong>” specified at 13 CFR<br />
121.201 where the SBA publishes “Small Business Size Standards by NAICS Industry.”<br />
The size standard associated with this NAICS code is set at $25 million in annual<br />
receipts 17 which “indicates the maximum allowed for a c<strong>onc</strong>ern and its affiliates to be<br />
considered small entities.”<br />
Based on our analysis, we believe that there is enough data generally available to<br />
establish that between 75% and 90% <strong>of</strong> entities that are categorized under the NAICS<br />
code 541511 are under the SBA size standard, but note that the available data does not<br />
show how many <strong>of</strong> these entities will develop a Complete EHR or EHR Module. We<br />
also note that with the exception <strong>of</strong> aggregate business information available through the<br />
U.S. Census Bureau and the SBA related to NAICS code 541511, it appears that many<br />
Complete EHR and EHR Module developers are privately held or owned and do not<br />
regularly, if at all, make their specific annual receipts publicly available. As a result, it is<br />
difficult to locate empirical data related to many <strong>of</strong> the Complete EHR and EHR Module<br />
developers to correlate to the SBA size standard.<br />
17 The SBA references that annual receipts means “total income” (or in the case <strong>of</strong> a sole proprietorship,<br />
“gross income”) plus “cost <strong>of</strong> goods sold” as these terms are defined and reported on Internal Revenue<br />
Service tax return forms.<br />
http://www.sba.gov/idc/groups/public/documents/sba_homepage/guide_to_size_standards.pdf<br />
Page 203 <strong>of</strong> 228
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