Department of health and human services
VIII. Regulatory Impact Statement
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- Bu səhifədəki naviqasiya:
- Estimated Health IT Developers and Development and Preparation Hours for Proposed Certification Criteria – Criteria Associated with the EHR Incentive Programs Stage 3 (“Stage 3 Criteria”)
- Estimated Health IT Developers and Development and Preparation Hours for Proposed Certification Criteria – Criteria Not Associated with the EHR Incentive Programs Stage 3 (“Independent Criteria”)
- Table 8. Total Development and Preparation Costs Per Criterion for Health IT Developers - Criteria Associated with the EHR Incentive Programs Stage 3 (“Stage 3 Criteria”)
- Table 9. Total Development and Preparation Costs Per Criterion for Health IT Developers – Criteria Not Associated with the EHR Incentive Programs Stage 3 (“Independent Criteria”)
- Federal Register
- Table 10. Distributed Total Development and Preparation Costs for Health IT Developers (4-year period) – Totals Rounded Year
- Total Average Cost Estimate ($M)
- List of Subjects in 45 CFR Part 170
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VIII. Regulatory Impact Statement A. Statement of Need This proposed rule is being published to adopt the 2015 Edition. Certification criteria and associated standards and implementation specifications would be used to test and certify health IT in order to make it possible for EPs, eligible hospitals, and CAHs to adopt and implement health IT that can be used to meet the CEHRT definition. EPs, eligible hospitals, and CAHs who participate in the EHR Incentive Programs are required by statute to use CEHRT.262 The certification criteria and associated standards and implementation specifications would also support the certification of more types of health IT and health IT that supports care and practice settings beyond the scope of the EHR Incentive Programs. The adoption and implementation of health IT certified to the 2015 Edition promotes interoperability in support of a nationwide health information infrastructure and improves health care quality, safety and efficiency consistent with the goals of the HITECH Act. B. Overall Impact We have examined the impact of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2011), the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), section 202 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532), and Executive Order 13132 on Federalism (August 4, 1999). 1. Executive Orders 12866 and 13563 – Regulatory Planning and Review Analysis Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). OMB has determined that this proposed rule is an economically significant rule as ONC has estimated the costs to develop and prepare health IT to be tested and certified may be greater than $100 million per year. Because of the public interest in this proposed rule, we have prepared an RIA that to the best of our ability presents the costs and benefits of the proposed rule. a. Costs This proposed rule proposes the adoption of standards, implementation specifications, and certification criteria that would establish the capabilities that health IT would need to demonstrate to be certified to the 2015 Edition. Our analysis focuses on the direct effects of the provisions of this proposed rule – the costs incurred by health IT developers to develop and prepare health IT to be tested and certified in accordance with the certification criteria (and the standards and implementation specifications they include) adopted by the Secretary. That is, we focus on the technological development and preparation costs necessary for health IT already certified to the 2014 Edition to upgrade to the proposed 2015 Edition and for, in limited cases, developing and preparing a new Health IT Module to meet the 2015 Edition. The costs for the testing and certification of health IT to the 2015 Edition were captured in the regulatory impact analysis of the Permanent Certification Program final rule as we discuss in more detail below (VIII.B.1.a.iii “Testing and Certification Costs for the 2015 Edition”). Because the costs that EPs, eligible hospitals, and CAHs would incur in adopting and implementing (including training, maintenance, and any other ongoing costs) health IT certified to the 2015 Edition is overwhelmingly attributable to CMS’s EHR Incentive Programs Stage 3 proposed rule (proposed elsewhere in this issue of the Federal Register), and would not be incurred in the absence of such rulemaking, such costs are not within the scope of the analysis of this proposed rule; similarly, any benefits that are contingent upon adoption and implementation would be attributable to CMS’s rulemaking.263 We also note that this proposed rule does not impose the costs cited as compliance costs, but rather as investments which health IT developers voluntarily take on and expect to recover with an appropriate rate of return. i. Development and Preparation Costs for the 2015 Edition The development and preparation costs we estimate are derived through a health IT developer per criterion cost. In simple terms, we estimate: (1) how many health developers will prepare and develop products against the proposed certification criteria; (2) how many products they will develop; and (3) what it will likely cost them to develop and prepare those products to meet the proposed certification criteria. We are not aware of an available independent study (e.g., a study capturing the preparation efforts and costs to develop and Health IT Modules to meet the requirements of the 2014 Edition) that we could rely upon as a basis for estimating the efforts and costs required to develop and prepare health IT to meet the 2015 Edition. We welcome comments identifying such a study or on any valid and reliable data upon which we could base our estimates in a subsequent final rule. Proposed Certification Criteria We have divided the proposed certification criteria into two tables. One table is for the certification criteria associated with EHR Incentive Programs Stage 3 proposed objectives and measures (“Stage 3 Criteria”). This table also includes certification criteria that are included in conditional certification requirements, such as privacy and security, safety-enhanced design, and quality management system certification criteria as certified Health IT Modules certified to these criteria would likely be used to meet the CEHRT definition under the EHR Incentive Programs. The second table is for all other proposed certification criteria (“Independent Criteria”). We have done this because, based on available data, we can more accurately estimate the number of health IT developers that may develop and prepare Health IT Modules for certification to proposed certification criteria associated with the EHR Incentive Programs. Health IT Developers We derive our estimates for the number of health IT developers by beginning with the number of Health IT developers certified to each of the 2014 Edition certification criteria as identified in CHPL data from November 10, 2014. For the Stage 3 Criteria that correspond to 2014 Edition certification criteria, we have reduced the number of Health IT developers by 30% from the number that certified against the 2014 Edition. We have done this because we have found a 22% drop in the number of health IT developers that certified technology against the 2014 Edition versus the 2011 Edition. We believe that as both interoperability requirements increase by edition and certain health IT developers gain more market share through competition and acquisition of other health IT developers, there will be an even greater drop in the number of health IT developers that seek certification to the 2015 Edition. We welcome comments on this assumption. For the Independent Criteria, we have established a number of health IT developers for all the criteria at 16. We derived this number by taking the lowest number of health IT developers certified to a 2014 Edition certification criteria and reducing that number by 50%. Only 32 health IT developers have certified to the 2014 Edition “transmission to cancer registries” certification criterion (§ 170.314(f)(6)) even though it is associated with an EHR Incentive Programs Stage 2 menu objective. The Independent Criteria are not currently associated with the EHR Incentive Programs or other HHS payment programs. Therefore, we estimate that a small number of health IT developers would certify to these criteria (i.e., 50% less than the least amount of health IT developers certified to a certification criterion that supports the EHR Incentive Programs). We welcome comments on our approach to estimating the number of health IT developers for Independent Criteria. We also seek comment on reasons (e.g., use cases) why health IT developers would currently seek certification to these criteria in general or for each proposed criteria. To note, the estimated number of Health IT developers for each criterion includes any potential new entrants to the market. Number of Health IT Modules We estimate 2.5 products per health IT developer for each Stage 3 criterion. We reached this estimate based both on the number of unique264 certified products listed on the CHPL as of November 10, 2014 divided by the number of health IT developers certified and stakeholder feedback on our Voluntary Edition proposed rule (79 FR 54474). We estimate 1 product for each of the Independent Criteria (60% less). As noted above, the Independent Criteria are not currently associated with the EHR Incentive Programs or other HHS payment programs. Therefore, it is not only unclear how many health IT developers will seek certification to these criteria, but also how many products they would certify to these criteria. We can only assume that the number of products certified by each health IT developer will likely be less than for Stage 3 Criteria. Again, we welcome comments on estimates. Average Development and Preparation Hours Our estimated average development hours are based on feedback we received in response to the RIA we completed for on our Voluntary Edition proposed rule and internal estimates for criteria where there is no external data to validly rely upon. As noted in the Voluntary Edition final rule, we have generally used estimates from the Electronic Health Record Association as a basis for our high estimates, where applicable. For the Stage 3 Criteria, we include the development and preparation for 2.5 certified products per health IT developer in the estimated average development and preparation hours. For the Independent Criteria, we have built in an estimate of 60% less overall development and preparation hours due to our assumption that a health IT developer would develop only one product. As mentioned above, for proposed 2015 Edition certification criteria that have a corresponding 2014 Edition criterion, we estimate only the development and preparation hours to meet the new and revised capabilities included in a proposed criterion.
We have based the effort levels on the hours necessary for a software developer to develop and prepare the health IT for testing and certification. The U.S. Department of Labor, Bureau of Labor Statistics estimates that the median hourly wage for a software developer is $44.55.265 We have also calculated the costs of an employee’s benefits by assuming that an employer expends thirty-six percent (36%) of an employee’s hourly wage on benefits for the employee. We have concluded that a 36% expenditure on benefits is an appropriate estimate because it is the routine percentage used by HHS for contract cost estimates. We have rounded up the average software developer’s wage with benefits to $61 per hour. To calculate our cost estimates for each certification criterion in the tables below, we have multiplied both the average low and average high number of development and preparation hours by $61. For tables 8 and 9, dollar amounts are expressed in 2013 dollars. For unchanged certification criteria,266 we have estimated a range of 0-50 hours to account for new entrants in the Stage 3 Criteria table (Table 6) and used 60% less of that estimate in the “Independent Criteria” table (Table 7). To illustrate, that would produce a high development hours of 12,700 for the “medication list” criterion (item # 7). This likely still overestimates the burden hours of all potential new entrants. Estimated Health IT Developers and Development Hours Per Criterion
Estimated Cost Per Criterion for Health IT Developers
ii. Overall Development and Preparation Costs Over a Four-year Period We estimate the development and preparation costs over a four-year period because a four-year period aligns with our estimated publication date for a subsequent final rule (Summer 2015) and the year in which CMS proposes that participants in the EHR Incentive Programs must use health IT certified to the 2015 Edition (2018) (see the EHR Incentive Programs Stage 3 proposed rule published elsewhere in this issue of the Federal Register). In total, we estimate the overall costs to develop and prepare health IT for certification over a four-year period to be $197.43 million to $407.20 million, with a cost mid-point of approximately $302.32 million. Evenly distributed over calendar years 2015 through 2018, the cost range would be $49.36 million to $101.80 per year with an annual cost mid-point of approximately $75.58. However, we project these costs to be unevenly distributed. We estimate the distribution as follows: 2015 (25%); 2016 (30%); 2017 (30%); and 2018 (15%). We reached this distribution based on these assumptions and information: We expect a subsequent 2015 Edition final rule to be published in the summer of 2015 and for health IT developers to spend the rest of the year preparing and developing their health IT to meet the 2015 Edition. We expect health IT developers to aggressively work in 2016 and 2017 to prepare and develop their health IT to meet the 2015 Edition as the compliance date for the EHR Incentive Programs CEHRT definition draws near (i.e., 2018) and because health IT certified to the 2015 Edition could be used in 2017 under the EHR Incentive Programs Stage 3 proposal for the CEHRT definition. We expect health IT developers to continue to prepare and develop health IT to the 2015 Edition in 2018 based on their approach to the 2014 Edition. Table 10 below represents the costs attributable to this proposed rule distributed as discussed above. The dollar amounts expressed in Table 10 are expressed in 2013 dollars.
iii. Testing and Certification Costs for the 2015 Edition In the RIA of the Permanent Certification Program final rule, we estimated the costs for testing and certification of technologies that would be used for providers to attempt to achieve EHR Incentive Programs Stages 1-3.267 These costs were based on the requirements of the certification program and a two-year rulemaking cycle for the CEHRT definition and each EHR Incentive Programs stage. We believe the costs we attributed to testing and certification of technologies in support of EHR Incentive Programs Stage 2 in the Permanent Certification Program final rule would encompass the actual testing and certification of technologies to both the 2014 and 2015 Editions. This assessment is based on the number of technologies currently certified to the 2014 Edition and our projections in this proposed rule for the number of technologies that would likely be tested and certified to the 2015 Edition. Further, we note that the estimated costs in the Permanent Certification Program final rule included costs for surveillance of technologies and also estimated the costs for testing and certification above what we understand are the cost ranges charged by ONC-ACBs today. We welcome comments on our determination and our cost estimates. b. Benefits We believe that there will be several significant benefits that may arise from this proposed rule for patients, health care providers, and health IT developers. The 2015 Edition continues to improve health IT interoperability through the adoption of new and updated standards and implementation specifications. For example, many proposed certification criteria include standards and implementation specifications for interoperability that directly support the EHR Incentive Programs, which include objectives and measures for the interoperable exchange of health information and for providing patients electronic access to their health information in structured formats. In addition, proposed certification criteria that support the collection of patient data that could be used to address health disparities would not only benefit patients, but the entire health care delivery system through improved quality of care. The 2015 Edition also supports usability and patient safety through new and enhanced certification requirements for health IT. Our proposals to make the ONC Health IT Certification Program open and accessible to more types of health IT and for health IT that supports a variety of care and practice settings should benefit health IT developers, providers practicing in other care/practice settings, and consumers through the availability and use of certified health IT that includes capabilities that promote interoperability and enhanced functionality.268 We welcome comment on other benefits, including monetary savings, which could be achieved through the proposals we have put forth in this proposed rule. 2. Regulatory Flexibility Act (RFA) 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. The Small Business Administration (SBA) establishes the size of small businesses for federal government programs based on average annual receipts or the average employment of a firm. While health IT developers that pursue certification under the ONC Health IT Certification Program represent a small segment of the overall information technology industry, we believe that the entities impacted by this proposed 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 SBA size standard associated with this NAICS code is set at $27.5 million in annual receipts269 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 health IT product that will be certified to the 2015 Edition under the ONC Health IT Certification Program. 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 health IT developers that pursue certification under the ONC Health IT Certification Program 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 these health IT developers to correlate to the SBA size standard. However, although not correlated to the size standard for NAICS code 541511, we do have information indicating that over 60% of health IT developers that have had Complete EHRs and/or EHR Modules certified to the 2011 Edition have less than 51 employees. We estimate that this proposed rule would have effects on health IT developers that are likely to pursue certification under the ONC Health IT Certification Program, some of which may be small entities. However, we believe that we have proposed the minimum amount of requirements necessary to accomplish our policy goals, including a reduction in regulatory burden and additional flexibility for the regulated community, and that no additional appropriate regulatory alternatives could be developed to lessen the compliance burden associated with this proposed rule. We note that this proposed rule does not impose the costs cited in the RIA as compliance costs, but rather as investments which these health IT developers voluntarily take on and expect to recover with an appropriate rate of return. Accordingly, we do not believe that the proposed rule will create a significant impact on a substantial number of small entities, but request comment on whether there are small entities that we have not identified that may be affected in a significant way by this proposed rule. Additionally, the Secretary certifies that this proposed rule will not have a significant impact on a substantial number of small entities. 3. Executive Order 13132 - Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. Nothing in this proposed rule imposes substantial direct compliance costs on state and local governments, preempts state law or otherwise has federalism implications. We are not aware of any State laws or regulations that are contradicted or impeded by any of the standards, implementation specifications, or certification criteria that we propose for adoption. 4. Unfunded Mandates Reform Act of 1995 Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. The current inflation-adjusted statutory threshold is approximately $141 million. This proposed rule will not impose an unfunded mandate on State, local, and tribal governments or on the private sector that will reach the threshold level. OMB reviewed this proposed rule.
Computer technology, Electronic health record, Electronic information system, Electronic transactions, Health, Health care, Health information technology, Health insurance, Health records, Hospitals, Incorporation by reference, Laboratories, Medicaid, Medicare, Privacy, Reporting and recordkeeping requirements, Public health, Security. For the reasons set forth in the preamble, 45 CFR subtitle A, subchapter D, part 170, is proposed to be amended as follows: Yüklə 1,55 Mb. Dostları ilə paylaş:
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