[Congressional Record (Bound Edition), Volume 163 (2017), Part 7]
[Extensions of Remarks]
[Pages 10098-10099]
[From the U.S. Government Publishing Office, www.gpo.gov]




                 INTRODUCTION OF AMENDMENT TO H.R. 1215

                                 ______
                                 

                             HON. ANDY BARR

                              of kentucky

                    in the house of representatives

                        Wednesday, June 28, 2017

  Mr. BARR. Mr. Speaker, I include in the Record an amendment I 
introduced to Rules Committee Print 115-10 on H.R. 1215:

       Add, at the end of the bill, the following (and amend the 
     table of contents accordingly):

     SEC. 11. REQUIREMENTS FOR SELECTION OF CLINICAL PRACTICE 
                   GUIDELINES.

       (a) Selection.--Not later than 6 months after the date of 
     enactment of this Act, eligible professional organizations 
     that have established, published, maintained, and updated on 
     a regular basis, clinical practice guidelines, including when 
     applicable, appropriate use criteria, that incorporate best 
     practices, may submit such guidelines to the Secretary of 
     Health and Human Services. Not later than 6 months after the 
     last day for submitting such guidelines, the Secretary shall 
     select and designate one or more eligible professional 
     organizations to provide and maintain such clinical practice 
     guidelines on behalf of the Secretary. Not later than 6 
     months after designating each such eligible professional 
     organization, the Secretary shall enter into an agreement 
     with each such eligible professional organization for 
     maintenance, publication, and updating of such clinical 
     practice guidelines.
       (b) Maintenance.--
       (1) Periodic Review.--Not later than 5 years after the 
     Secretary enters into an agreement with each eligible 
     professional organization under subsection (a), and every 5 
     years thereafter, the Secretary shall review the clinical 
     practice guidelines of such organization and shall, as 
     necessary, enter into agreements with additional eligible 
     professional organizations, as appropriate, in accordance 
     with subsection (a).
       (2) Update by eligible professional organization.--An 
     eligible professional organization that collaborated in the 
     establishment of a clinical practice guideline may

[[Page 10099]]

     submit amendments to that clinical practice guideline at any 
     time to the Secretary for review by the Secretary.
       (3) Notification required for certain updates.--An 
     amendment under paragraph (2) may not add, materially change, 
     or remove a guideline from a set of guidelines, unless 
     notification of such update is made available to applicable 
     eligible professionals.

     SEC. 12. DEVELOPMENT.

       (a) Guideline Standards.--The Secretary shall ensure that, 
     to the extent practicable, the development of clinical 
     practice guidelines are guided by the Standards for 
     Developing Trustworthy Clinical Practice Guidelines of the 
     Institute of Medicine and--
       (1) are developed through a transparent process that 
     minimizes conflicts of interest;
       (2) are developed by a knowledgeable, multidisciplinary 
     panel of experts and representatives from key affected 
     groups;
       (3) take into consideration important patient subgroups and 
     patient preferences, as appropriate;
       (4) are based on a systematic review of the existing 
     evidence;
       (5) except in the case of diagnostic guidelines, provide a 
     clear explanation of the relationship between care options 
     and health outcomes;
       (6) except in the case of diagnostic guidelines, provide 
     ratings of both the quality of evidence and strength of 
     recommendation;
       (7) are reconsidered and revised when new evidence emerges; 
     and
       (8) clearly identify any exceptions to the application of 
     the clinical practice guideline.
       (b) Required Disclosures From Eligible Professional 
     Organizations.--Any person who is affiliated with an eligible 
     professional organization and who directly participated in 
     the creation of a clinical practice guideline shall follow 
     that particular eligible professional organization's conflict 
     of interest protocol.

     SEC. 13. NO LIABILITY FOR GUIDELINE PRODUCERS.

       Neither an eligible professional organization nor the 
     participants in its guideline development and approval 
     process, may be held liable for any injury alleged to be 
     caused by adhering to a clinical practice guideline to which 
     they contributed.

     SEC. 14. INTERNET PUBLICATION OF GUIDELINES.

       The Secretary shall publish on the Internet through the 
     National Guideline Clearinghouse or other appropriate sites 
     or sources, all clinical practice guidelines, including all 
     data and methodology used in the development and selection of 
     the guidelines in compliance with data disclosure standards 
     in the Health Insurance Portability and Accountability Act of 
     1996 (Public Law 104-191).

     SEC. 15. AFFIRMATIVE DEFENSE.

       In the case of a health care lawsuit, it shall be an 
     affirmative defense to any health care liability claim 
     alleged therein that the defendant complied with a clinical 
     practice guideline that was applicable to the provision or 
     use of health care services or medical products for which the 
     health care liability claim is brought.

     SEC. 16. DEFINITIONS.

       For purposes of sections 11 through 14:
       (1) Applicable eligible professional.--The term 
     ``applicable eligible professional'' means a physician 
     practicing within clinical practice guidelines submitted by 
     an eligible professional organization and includes employees 
     and agents of a physician.
       (2) Appropriate use criteria.--The term ``appropriate, use 
     criteria'' means established evidence-based guidelines 
     developed or endorsed by an eligible professional 
     organization that specify when the health benefits of a 
     procedure or service exceed the expected health risks by a 
     significantly wide margin.
       (3) Clinical practice guideline.--The term ``clinical 
     practice guideline'' means systematically developed 
     statements based on the review of clinical evidence for 
     assisting a health care provider to determine the appropriate 
     health care in specific clinical circumstances.
       (4) Diagnostic guideline.--The term ``diagnostic 
     guideline'' means a clinical practice guideline that provides 
     recommendation regarding the utility of diagnosis procedures 
     for a specific clinical scenario.
       (5) Eligible professional organization.--The term 
     ``eligible professional organization'' means a national or 
     State medical society or medical specialty society.
       (6) Federal payor.--The term ``Federal payor'' includes 
     reimbursements made under the Medicare program under title 
     XVIII of the Social Security Act or the Medicaid program 
     under title XIX of the Social Security Act, premium tax 
     credits under section 36B of the Internal Revenue Code of 
     1986 or cost-sharing reductions under section 1402 of the 
     Patient Protection and Affordable Care Act, or medical 
     screenings, treatments, or transfer services provided 
     pursuant to section 1867 of the Social Security Act.
       (7) Health care organization.--The term ``health care 
     organization'' means any person or entity which is obligated 
     to provide or pay for health benefits under any health plan, 
     including any person or entity acting under a contract or 
     arrangement with a health care organization to provide or 
     administer any health benefit.
       (8) Health care provider.--The term ``health care 
     provider'' means any person or entity required by State or 
     Federal laws or regulations to be licensed, registered, or 
     certified to provide health care services, and being either 
     so licensed, registered, or certified, or exempted from such 
     requirement by other statute or regulation.
       (9) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.

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