[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5214 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 5214

 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

_______________________________________________________________________

                                 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.

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

SECTION 1. RECOMMENDATIONS FOR DEVELOPMENT AND USE OF CLINICAL DATA 
              REGISTRIES.

    (a) In General.--Not later than one year after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
make recommendations for the development and use, when appropriate, of 
clinical data registries that are integrated with clinical practice 
guidelines and best practices or standards of care, including 
registries designed to minimize duplication and burden on those 
operating or reporting to such registries, for the improvement of 
patient care. The Secretary shall make such recommendations available 
to the public by posting them on a public Website of the Department of 
Health and Human Services.
    (b) Specific Recommendations.--Such recommendations, with respect 
to such registries, shall include the following:
            (1) Recommendations for a set of standards that, if adopted 
        by such registries, would allow for the bidirectional, 
        interoperable exchange of information between the electronic 
        health records of the reporting clinicians and such registries.
            (2) Recommendations on how clinical registries, including 
        outcomes-based registries, may be developed and then used to 
        evaluate various care models and methods, including improved 
        clinical care coordination, and the impact of such models and 
        methods on the management of diseases as measured by 
        appropriate care parameters based on clinical practice 
        guidelines and best practices (such as A1C, blood pressure, and 
        cholesterol levels in the case of diabetes).
            (3) Recommendations on how such registries should be 
        structured to facilitate the recording and reporting of post-
        market data for the purposes of monitoring safety and efficacy 
        of FDA-approved devices and drugs, reporting relevant clinical 
        data to satisfy attestation requirements for coverage of 
        prescribed devices and drugs, and better defining appropriate 
        clinical use in support of evidence development for the 
        Medicare program (such as improving patient access to safe and 
        effective glucose monitoring systems and future glucose 
        monitoring technologies).
            (4) Recommendations on how data from such registries may be 
        used to inform physicians and other health care professionals 
        regarding clinical practices for the prevention of diseases 
        (such as diabetes and the precursor conditions of diabetes) and 
        appropriate methods for the dissemination of clinical practice 
        support tools and other educational resources that may be 
        derived from registry data.
            (5) Recommendations for how registries can be used to 
        promote preventive health benefits such as screenings and the 
        Medicare annual wellness visits that may reduce the risk of 
        chronic diseases (such as obesity, osteoporosis, cardiovascular 
        disease, cancer, diabetes and their complications).
    (c) Consultation With Clinical Experts.--The Secretary shall 
consult with national medical specialty societies and with 
manufacturers of drugs and medical devices in the development of such 
recommendations as they relate to the diseases that they (or their 
manufactured drugs or devices) manage and treat (such as with 
endocrinologists with respect to recommendations relating to diabetes 
and pre-diabetes conditions).
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