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

                                                 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]


_______________________________________________________________________

                                 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 
recommendations 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--
                    (A) the recording and reporting of post-market data 
                for the purposes of monitoring safety and efficacy of 
                FDA-approved devices and drugs;
                    (B) the reporting of relevant clinical data to 
                satisfy attestation requirements for coverage of 
                prescribed devices; and
                    (C) coverage with evidence development policies for 
                devices under the Medicare program (such as improving 
                patient access to safe and effective glucose monitoring 
                systems).
            (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, patient groups, 
technology vendors, and developers and manufacturers of drugs and 
medical devices in the development of such recommendations as they 
relate to the diseases that members of such societies manage and treat 
(such as with endocrinologists with respect to recommendations relating 
to diabetes and pre-diabetes conditions).
    (d) Rule of Construction.--Nothing in this section may be construed 
as--
            (1) authorizing the Secretary of Health and Human Services 
        to take any action with regard to the recommendations made 
        under this section (other than making such recommendations 
        available to the public in the manner described in subsection 
        (a));
            (2) limiting or interfering with the authority of a health 
        care practitioner to practice medicine or to prescribe or 
        administer a drug or device to an individual for a condition or 
        disease; or
            (3) providing the Centers for Medicare & Medicaid Services 
        with authority to limit (or to encourage other individuals or 
        entities to limit) coverage under the Medicare program under 
        title XVIII of the Social Security Act for an item or service 
        furnished to an individual on account of the participation, or 
        lack of participation, of the individual in a registry or other 
        data collection system.
                                                 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 Services to provide for 
recommendations for the development and use of clinical data registries 
                  for the improvement of patient care.

_______________________________________________________________________

                           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