Department of health and human services


VIII. Regulatory Impact Statement



Yüklə 1,55 Mb.
səhifə24/29
tarix06.09.2018
ölçüsü1,55 Mb.
#78527
1   ...   21   22   23   24   25   26   27   28   29


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.

Health IT Developer Hourly Cost and Cost Range

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

Table 6. 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”)

Item #

CFR Text

Certification Criterion Name

Number of Health IT Developers who Develop Product(s) for Certification to Criterion

Hourly Development Effort by Health IT Developer

Low Avg

High Avg

1

§ 170.315(a)(1)

CPOE – medications

83.3

0

50

2

§ 170.315(a)(2)

CPOE – laboratory

83.3

1000

2000

3

§ 170.315(a)(3)

CPOE – diagnostic imaging

83.3

0

50

4

§ 170.315(a)(4)

DD/DAI Checks for CPOE

242.2

400

800

5

§ 170.315(a)(5)

Demographics

268.8

500

1000

6

§ 170.315(a)(7)

Problem List

256.9

100

200

7

§ 170.315(a)(8)

Medication List

254.8

0

50

8

§ 170.315(a)(9)

Medication Allergy List

252.7

0

50

9

§ 170.315(a)(10)

Clinical Decision Support

235.2

600

1200

10

§ 170.315(a)(11)

Drug-formulary and Preferred Drug List Checks

233.1

310

620

11

§ 170.315(a)(12)

Smoking Status

266.7

100

200

12

§ 170.315(a)(14)

Family Health History

216

100

200

13

§ 170.315(a)(15)

Family Health History - pedigree

24

500

1200

14

§ 170.315(a)(17)

Patient-specific Education Resources

249.2

600

1200

15

§ 170.315(a)(19)

Patient Health Information Capture

88.9

500

1000

16

§ 170.315(a)(20)

Implantable Device List

90

1100

1,700

17

§ 170.315(b)(1)

Transitions of Care

242.9

1550

3100

18

§ 170.315(b)(2)

Clinical Information Reconciliation and Incorporation

224

600

1200

19

§ 170.315(b)(3)

Electronic Prescribing

224.7

1050

2100

20

§ 170.315(b)(6)

Data Portability

228.9

800

1600

21

§ 170.315(c)(1)

CQMs – record and export

246.4

200

500

22

§ 170.315(d)(1)

Authentication, Access Control, Authorization

333.9

0

50

23

§ 170.315(d)(2)

Auditable Events and Tamper-resistance

272.3

0

50

24

§ 170.315(d)(3)

Audit Report(s)

280

0

50

25

§ 170.315(d)(4)

Amendments

243.6

0

50

26

§ 170.315(d)(5)

Automatic Access Time-out

333.9

0

50

27

§ 170.315(d)(6)

Emergency Access

308.7

0

50

28

§ 170.315(d)(7)

End-User Device Encryption

267.4

0

50

29

§ 170.315(d)(8)

Integrity

312.2

0

50

30

§ 170.315(e)(1)

View, Download, and Transmit to 3rd party

256.2

1000

2000

31

§ 170.315(e)(2)

Secure Messaging

246.4

0

50

32

§ 170.315(f)(1)

Transmission to Immunization Registries

220.5

680

1360

33

§ 170.315(f)(2)

Transmission to Public Health Agencies—syndromic surveillance

213.5

480

960

34

§ 170.315(f)(3)

Transmission to Public Health Agencies – reportable laboratory tests and values/results

49

520

1040

35

§ 170.315(f)(4)

Transmission to Cancer Registries

22.4

500

1000

36

§ 170.315(f)(5)

Transmission to Public Health Agencies – case reporting

21

500

1000

37

§ 170.315(f)(6)

Transmission to Public Health Agencies – antimicrobial use and resistance reporting

21

500

1000

38

§ 170.315(f)(7)

Transmission to Public Health Agencies – health care surveys

21

500

1000

39

§ 170.315(g)(1)

Automated Numerator Recording

113.4

400

800

40

§ 170.315(g)(2)

Automated Measure Calculation

264.6

600

1200

41

§ 170.315(g)(3)

Safety-enhanced Design

266

300

600

42

§ 170.315(g)(4)

Quality Management System

401.8

400

800

43

§ 170.315(g)(6)

Consolidated CDA Creation Performance

242

400

1000

44

§ 170.315(g)(7)

Application Access to Common Clinical Data Set

242

500

1000

45

§ 170.315(g)(8)

Accessibility-Centered Design

401.8

50

100

46

§ 170.315(h)(1)

Direct Project

140

0

50

47

§ 170.315(h)(2)

Direct Project, Edge Protocol, and XDR/XDM

70

0

50




Table 7. 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”)

Item #

CFR Text

Certification Criterion Name

Number of Health IT Developers who Develop Product(s) for Certification to Criterion

Hourly Development Effort by Health IT Developer

Low Avg

High Avg

1

§ 170.315(a)(6)

Vital Signs, BMI, and Growth Charts

16

614

922

2

§ 170.315(a)(13)

Image Results

16

0

20

3

§ 170.315(a)(16)

Patient List Creation

16

0

20

4

§ 170.315(a)(18)

Electronic Medication Administration Record

16

0

20

5

§ 170.315(a)(21)

Social, Psychological, and Behavioral Data

16

235

470

6

§ 170.315(a)(22)

Decision Support – knowledge artifact

16

394

788

7

§ 170.315(a)(23)

Decision Support – service

16

229

458

8

§ 170.315(b)(4)

Incorporate Laboratory Tests and Values/Results

16

313

626

9

§ 170.315(b)(5)

Transmission of Laboratory Test Reports

16

360

720

10

§ 170.315(b)(7)

Data Segmentation for Privacy – send

16

450

900

11

§ 170.315(b)(8)

Data Segmentation for Privacy – receive

16

450

900

12

§ 170.315(b)(9)

Care Plan

16

300

500

13

§ 170.315(c)(2)

CQMs – import and calculate

16

0

200

14

§ 170.315(c)(4)

CQMs – filter

16

316

632

15

§ 170.315(d)(9)

Accounting of Disclosures

16

0

20

16

§ 170.315(g)(5)

Accessibility Technology Compatibility

16

800

1400

17

§ 170.315(h)(3)

SOAP Transport and Security Specification and XDR/XDR for Direct Messaging

16

0

20

18

§ 170.315(h)(4)

Healthcare Provider Directory – query request

16

120

240

19

§ 170.315(h)(5)

Healthcare Provider Directory – query response

16

120

240

20

§ 170.315(i)(1)

Electronic Submission of Medical Documentation

16

1000

2000


Estimated Cost Per Criterion for Health IT Developers

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”)

Item #

CFR Text

Certification Criterion Name

Average Cost Estimates ($)


Average

Low


($)

Average

High


($)

1

§ 170.315(a)(1)

CPOE – medications

0

254,065

2

§ 170.315(a)(2)

CPOE – laboratory

508,1300

1,0162,600

3

§ 170.315(a)(3)

CPOE – diagnostic imaging

0

254,065

4

§ 170.315(a)(4)

DD/DAI Checks for CPOE

5,909,680

11,819,360

5

§ 170.315(a)(5)

Demographics

8,198,400

16,396,800

6

§ 170.315(a)(7)

Problem List

1,567,090

3,134,180

7

§ 170.315(a)(8)

Medication List

0

777,140

8

§ 170.315(a)(9)

Medication Allergy List

0

770,735

9

§ 170.315(a)(10)

Clinical Decision Support

8,608,320

17,216,640

10

§ 170.315(a)(11)

Drug-formulary and Preferred Drug List Checks

4,407,921

8,815,842

11

§ 170.315(a)(12)

Smoking Status

1,626,870

3,253,740

12

§ 170.315(a)(14)

Family Health History

1,317,600

2,635,200

13

§ 170.315(a)(15)

Family Health History - pedigree

732,000

1,756,800

14

§ 170.315(a)(17)

Patient-specific Education Resources

9,120,720

18,241,440

15

§ 170.315(a)(19)

Patient Health Information Capture

2,711,450

5,422,900

16

§ 170.315(a)(20)

Implantable Device List

6,039,000

9,333,000

17

§ 170.315(b)(1)

Transitions of Care

22,966,195

45,932,390

18

§ 170.315(b)(2)

Clinical Information Reconciliation and Incorporation

8,198,400

16,396,800

19

§ 170.315(b)(3)

Electronic Prescribing

14,392,035

28,784,070

20

§ 170.315(b)(6)

Data Portability

1,117,0320

22,340,640

21

§ 170.315(c)(1)

CQMs – record and export

3,006,080

7,515,200

22

§ 170.315(d)(1)

Authentication, Access Control, Authorization

0

1,018,395

23

§ 170.315(d)(2)

Auditable Events and Tamper-resistance

0

830,515

24

§ 170.315(d)(3)

Audit Report(s)

0

854,000

25

§ 170.315(d)(4)

Amendments

0

742,980

26

§ 170.315(d)(5)

Automatic Access Time-out

0

1,018,395

27

§ 170.315(d)(6)

Emergency Access

0

941,535

28

§ 170.315(d)(7)

End-User Device Encryption

0

815,570

29

§ 170.315(d)(8)

Integrity

0

952,210

30

§ 170.315(e)(1)

View, Download, and Transmit to 3rd party

15,628,200

31,256,400

31

§ 170.315(e)(2)

Secure Messaging

0

751,520

32

§ 170.315(f)(1)

Transmission to Immunization Registries

9,146,340

18,292,680

33

§ 170.315(f)(2)

Transmission to Public Health Agencies—syndromic surveillance

6,251,280

12,502,560

34

§ 170.315(f)(3)

Transmission to Public Health Agencies – reportable laboratory tests and values/results

1,554,280

3,108,560

35

§ 170.315(f)(4)

Transmission to Cancer Registries

683,200

1,366,400

36

§ 170.315(f)(5)

Transmission to Public Health Agencies – case reporting

640,500

1,281,000

37

§ 170.315(f)(6)

Transmission to Public Health Agencies – antimicrobial use and resistance reporting

640,500

1,281,000

38

§ 170.315(f)(7)

Transmission to Public Health Agencies – health care surveys

640,500

1,281,000

39

§ 170.315(g)(1)

Automated Numerator Recording

2,766,960

5,533,920

40

§ 170.315(g)(2)

Automated Measure Calculation

9,684,360

19,368,720

41

§ 170.315(g)(3)

Safety-enhanced Design

4867800

9,735,600

42

§ 170.315(g)(4)

Quality Management System

9,803,920

19,607,840

43

§ 170.315(g)(6)

Consolidated CDA Creation Performance

5,904,800

14,762,000

44

§ 170.315(g)(7)

Application Access to Common Clinical Data Set

7,381,000

14,762,000

45

§ 170.315(g)(8)

Accessibility-Centered Design

1,225,490

2,450,980

46

§ 170.315(h)(1)

Direct Project

0

427,000

47

§ 170.315(h)(2)

Direct Project, Edge Protocol, and XDR/XDM

0

213,500




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”)

Item #

CFR Text

Certification Criterion Name

Average Cost Estimates ($)

Average

Low


($)

Average

High


($)

1

§ 170.315(a)(6)

Vital Signs, BMI, and Growth Charts

599,264

899,872

2

§ 170.315(a)(13)

Image Results

0

19,520

3

§ 170.315(a)(16)

Patient List Creation

0

19,520

4

§ 170.315(a)(18)

Electronic Medication Administration Record

0

19,520

5

§ 170.315(a)(21)

Social, Psychological, and Behavioral Data

229,360

458,720

6

§ 170.315(a)(22)

Decision Support – knowledge artifact

384,544

769,088

7

§ 170.315(a)(23)

Decision Support – service

223,504

447,008

8

§ 170.315(b)(4)

Incorporate Laboratory Tests and Values/Results

305,488

610,976

9

§ 170.315(b)(5)

Transmission of Laboratory Test Reports

351,360

702,720

10

§ 170.315(b)(7)

Data Segmentation for Privacy – send

439,200

878,400

11

§ 170.315(b)(8)

Data Segmentation for Privacy – receive

439,200

878,400

12

§ 170.315(b)(9)

Care Plan

292,800

488000

13

§ 170.315(c)(2)

CQMs – import and calculate

0

195,200

14

§ 170.315(c)(4)

CQMs – filter

308,416

616,832

15

§ 170.315(d)(9)

Accounting of Disclosures

0

19,520

16

§ 170.315(g)(5)

Accessibility Technology Compatibility

780,800

1,366,400

17

§ 170.315(h)(3)

SOAP Transport and Security Specification and XDR/XDR for Direct Messaging

0

19,520

18

§ 170.315(h)(4)

Healthcare Provider Directory – query request

117,120

234,240

19

§ 170.315(h)(5)

Healthcare Provider Directory – query response

117,120

234,240

20

§ 170.315(i)(1)

Electronic Submission of Medical Documentation

976,000

1,952,000

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.



Table 10. Distributed Total Development and Preparation Costs for Health IT Developers (4-year period) – Totals Rounded

Year

Ratio

Total Low Cost Estimate

($M)

Total High Cost Estimate

($M)

Total Average Cost Estimate

($M)

2015

25%

49.36

101.80

75.58

2016

30%

59.23

122.16

90.70

2017

30%

59.23

122.16

90.70

2018

15%

29.61

61.08

45.35

4-Year Totals

197.43

407.20

302.32

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.

List of Subjects in 45 CFR Part 170

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:
1   ...   21   22   23   24   25   26   27   28   29




Verilənlər bazası müəlliflik hüququ ilə müdafiə olunur ©muhaz.org 2024
rəhbərliyinə müraciət

gir | qeydiyyatdan keç
    Ana səhifə


yükləyin