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Union Calendar No. 514 

113TH CONGRESS 

2D SESSION H. R. 5214 

[Report No. 113–683] 

To require the Secretary of Health and Human Services to provide for 

recommendations for the development and use of clinical data registries 

for the improvement of patient care. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 28, 2014 

Mr. OLSON introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

DECEMBER 22, 2014 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on July 28, 2014] 


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•HR 5214 RH

A BILL 

To require the Secretary of Health and Human Services 

to provide for recommendations for the development and 

use of clinical data registries for the improvement of 

patient care. 


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•HR 5214 RH

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. RECOMMENDATIONS FOR DEVELOPMENT AND 

4 USE OF CLINICAL DATA REGISTRIES. 

5 (a) IN GENERAL.—Not later than one year after the 

6 date of the enactment of this Act, the Secretary of Health 

7 and Human Services shall make recommendations for the 

8 development and use, when appropriate, of clinical data 

9 registries that are integrated with clinical practice guide10 lines and best practices or standards of care, including rec11 ommendations designed to minimize duplication and bur12 den on those operating or reporting to such registries, for 

13 the improvement of patient care. The Secretary shall make 

14 such recommendations available to the public by posting 

15 them on a public Website of the Department of Health and 

16 Human Services. 

17 (b) SPECIFIC RECOMMENDATIONS.—Such rec18 ommendations, with respect to such registries, shall include 

19 the following: 

20 (1) Recommendations for a set of standards that, 

21 if adopted by such registries, would allow for the 

22 bidirectional, interoperable exchange of information 

23 between the electronic health records of the reporting 

24 clinicians and such registries. 


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•HR 5214 RH

1 (2) Recommendations on how clinical registries, 

2 including outcomes-based registries, may be developed 

3 and then used to evaluate various care models and 

4 methods, including improved clinical care coordina5 tion, and the impact of such models and methods on 

6 the management of diseases as measured by appro7 priate care parameters based on clinical practice 

8 guidelines and best practices (such as A1C, blood 

9 pressure, and cholesterol levels in the case of diabetes). 

10 (3) Recommendations on how such registries 

11 should be structured to facilitate— 

12 (A) the recording and reporting of post13 market data for the purposes of monitoring safe14 ty and efficacy of FDA-approved devices and 

15 drugs; 

16 (B) the reporting of relevant clinical data to 

17 satisfy attestation requirements for coverage of 

18 prescribed devices; and 

19 (C) coverage with evidence development 

20 policies for devices under the Medicare program 

21 (such as improving patient access to safe and ef22 fective glucose monitoring systems). 

23 (4) Recommendations on how data from such 

24 registries may be used to inform physicians and other 

25 health care professionals regarding clinical practices 


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1 for the prevention of diseases (such as diabetes and 

2 the precursor conditions of diabetes) and appropriate 

3 methods for the dissemination of clinical practice sup4 port tools and other educational resources that may be 

5 derived from registry data. 

6 (5) Recommendations for how registries can be 

7 used to promote preventive health benefits such as 

8 screenings and the Medicare annual wellness visits 

9 that may reduce the risk of chronic diseases (such as 

10 obesity, osteoporosis, cardiovascular disease, cancer, 

11 diabetes and their complications). 

12 (c) CONSULTATION WITH CLINICAL EXPERTS.—The 

13 Secretary shall consult with national medical specialty so14 cieties, patient groups, technology vendors, and developers 

15 and manufacturers of drugs and medical devices in the de16 velopment of such recommendations as they relate to the 

17 diseases that members of such societies manage and treat 

18 (such as with endocrinologists with respect to recommenda19 tions relating to diabetes and pre-diabetes conditions). 

20 (d) RULE OF CONSTRUCTION.—Nothing in this section 

21 may be construed as— 

22 (1) authorizing the Secretary of Health and 

23 Human Services to take any action with regard to the 

24 recommendations made under this section (other than 


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1 making such recommendations available to the public 

2 in the manner described in subsection (a)); 

3 (2) limiting or interfering with the authority of 

4 a health care practitioner to practice medicine or to 

5 prescribe or administer a drug or device to an indi6 vidual for a condition or disease; or 

7 (3) providing the Centers for Medicare & Med8 icaid Services with authority to limit (or to encour9 age other individuals or entities to limit) coverage 

10 under the Medicare program under title XVIII of the 

11 Social Security Act for an item or service furnished 

12 to an individual on account of the participation, or 

13 lack of participation, of the individual in a registry 

14 or other data collection system. 


tkelley on DSK3SPTVN1PROD with BILLS

tkelley on DSK3SPTVN1PROD with BILLS
Union Calendar No. 514 

113TH CONGRESS 

2D SESSION H. R. 5214 

[Report No. 113–683] 

A BILL 

To require the Secretary of Health and Human 

for the improvement of patient care. development and use of clinical data registries Services to provide for recommendations for the 

DECEMBER 22, 2014 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


tkelley on DSK3SPTVN1PROD with BILLS