I 

115TH CONGRESS 

1ST SESSION H. R. 1565 

To provide for the creation of a safe harbor for defendants in medical 

malpractice actions who demonstrate adherence to clinical practice guidelines. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 16, 2017 

Mr. BARR (for himself, Mr. CUELLAR, Mr. ROE of Tennessee, Mr. PALAZZO, 

Mr. PITTENGER, Mr. ALLEN, Mr. ROUZER, Mr. MOOLENAAR, Mr. SMITH

of Texas, Mr. DUNN, Mr. AUSTIN SCOTT of Georgia, Mr. STEWART, and 

Mr. CARTER of Georgia) introduced the following bill; which was referred 

to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by 

the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To provide for the creation of a safe harbor for defendants 

in medical malpractice actions who demonstrate adherence to clinical practice guidelines. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Saving Lives, Saving 

5 Costs Act’’. 


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1 SEC. 2. REQUIREMENTS FOR SELECTION OF CLINICAL 

2 PRACTICE GUIDELINES. 

3 (a) SELECTION.—Not later than 6 months after the 

4 date of enactment of this Act, eligible professional organi5 zations that have established, published, maintained, and 

6 updated on a regular basis, clinical practice guidelines, in7 cluding when applicable, appropriate use criteria, that in8 corporate best practices, may submit such guidelines to 

9 the Secretary. Not later than 6 months after the last day 

10 for submitting such guidelines, the Secretary shall select 

11 and designate one or more eligible professional organiza12 tions to provide and maintain such clinical practice guide13 lines on behalf of the Secretary. Not later than 6 months 

14 after designating each such eligible professional organiza15 tion, the Secretary shall enter into an agreement with each 

16 such eligible professional organization for maintenance, 

17 publication, and updating of such clinical practice guide18 lines. 

19 (b) MAINTENANCE.— 

20 (1) PERIODIC REVIEW.—Not later than 5 years 

21 after the Secretary enters into an agreement with 

22 each eligible professional organization under sub23 section (a), and every 5 years thereafter, the Sec24 retary shall review the clinical practice guidelines of 

25 such organization and shall, as necessary, enter into 

26 agreements with additional eligible professional orgaVerDate Sep 11 2014 04:51 Mar 21, 2017 Jkt 069200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1565.IH H1565

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1 nizations, as appropriate, in accordance with sub2 section (a). 

3 (2) UPDATE BY ELIGIBLE PROFESSIONAL ORGA4 NIZATION.—An eligible professional organization 

5 that collaborated in the establishment of a clinical 

6 practice guideline may submit amendments to that 

7 clinical practice guideline at any time to the Sec8 retary for review by the Secretary. 

9 (3) NOTIFICATION REQUIRED FOR CERTAIN UP10 DATES.—An amendment under paragraph (2) may 

11 not add, materially change, or remove a guideline 

12 from a set of guidelines, unless notification of such 

13 update is made available to applicable eligible profes14 sionals. 

15 SEC. 3. DEVELOPMENT. 

16 (a) GUIDELINE STANDARDS.—The Secretary shall 

17 ensure that, to the extent practicable, the development of 

18 clinical practice guidelines are guided by the Standards 

19 for Developing Trustworthy Clinical Practice Guidelines of 

20 the Institute of Medicine and— 

21 (1) are developed through a transparent process 

22 that minimizes conflicts of interest; 

23 (2) are developed by a knowledgeable, multi24 disciplinary panel of experts and representatives 

25 from key affected groups; 


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1 (3) take into consideration important patient 

2 subgroups and patient preferences, as appropriate; 

3 (4) are based on a systematic review of the ex4 isting evidence; 

5 (5) except in the case of diagnostic guidelines, 

6 provide a clear explanation of the relationship be7 tween care options and health outcomes; 

8 (6) except in the case of diagnostic guidelines, 

9 provide ratings of both the quality of evidence and 

10 strength of recommendation; 

11 (7) are reconsidered and revised when new evi12 dence emerges; and 

13 (8) clearly identify any exceptions to the appli14 cation of the clinical practice guideline. 

15 (b) REQUIRED DISCLOSURES FROM ELIGIBLE PRO16 FESSIONAL ORGANIZATIONS.—Any person who is affili17 ated with an eligible professional organization and who di18 rectly participated in the creation of a clinical practice 

19 guideline shall follow that particular eligible professional 

20 organization’s conflict of interest protocol. 

21 SEC. 4. NO LIABILITY FOR GUIDELINE PRODUCERS. 

22 Neither an eligible professional organization nor the 

23 participants in its guideline development and approval 

24 process, may be held liable for any injury alleged to be 


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1 caused by adhering to a clinical practice guideline to which 

2 they contributed. 

3 SEC. 5. INTERNET PUBLICATION OF GUIDELINES. 

4 The Secretary shall publish on the Internet through 

5 the National Guideline Clearinghouse or other appropriate 

6 sites or sources, all clinical practice guidelines, including 

7 all data and methodology used in the development and se8 lection of the guidelines in compliance with data disclosure 

9 standards in the Health Insurance Portability and Ac10 countability Act of 1996 (Public Law 104–191). 

11 SEC. 6. STATE FLEXIBILITY AND PROTECTION OF STATES’ 

12 RIGHTS. 

13 (a) LIMITATION.—This Act shall not preempt or su14 persede any State or Federal law that— 

15 (1) imposes procedural or substantive protec16 tions for health care providers and health care orga17 nizations from liability, loss, or damages greater 

18 than such protections provided by this title; or 

19 (2) creates a cause of action related to the pro20 vision of health care goods or services. 

21 (b) STATE FLEXIBILITY.—No provision of this Act 

22 shall be construed to preempt any defense available to a 

23 party in a health care liability action under any other pro24 vision of State or Federal law. 


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1 SEC. 7. FEDERAL CAUSE OF ACTION. 

2 (a) IN GENERAL.—Chapter 85 of title 28, United 

3 States Code, is amended by adding at the end the fol4 lowing: 

5 ‘‘§ 1370. Health care liability claims 

6 ‘‘(a) DEFINITIONS.—In this section, the terms ‘appli7 cable eligible professional’, ‘health care goods or services’, 

8 ‘health care liability action’, ‘health care liability claim’, 

9 ‘health care organization’, and ‘health care provider’ have 

10 the meaning given such terms in section 10 of the Saving 

11 Lives, Saving Costs Act. 

12 ‘‘(b) JURISDICTION OF CLAIMS.—The district courts 

13 shall have original jurisdiction of a health care liability ac14 tion against an applicable eligible professional, health care 

15 provider, or health care organization. 

16 ‘‘(c) SUBSTANTIVE LAW.—The substantive law for 

17 decision in a health care liability action brought under 

18 subsection (b) shall be derived from the law, including 

19 choice of law principles, of the State in which the provision 

20 of, use of, or payment for (or the failure to provide, use, 

21 or pay for) health care goods or services giving rise to 

22 the health care liability claim occurred unless such law is 

23 inconsistent with or preempted by Federal law.’’. 

24 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

25 The table of sections for chapter 85 of title 28, United 


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1 States Code, is amended by adding at the end the fol2 lowing: 

‘‘1370. Health care liability claims.’’. 

3 SEC. 8. RIGHT OF REMOVAL. 

4 Section 1441 of title 28, United States Code, is 

5 amended by adding at the end the following: 

6 ‘‘(g) CERTAIN ACTIONS AGAINST MEDICAL PROFES7 SIONALS.—(1) A health care liability action brought in a 

8 State court against an applicable eligible professional, 

9 health care provider, or health care organization may be 

10 removed by any defendant or the defendants to the district 

11 court of the United States for the district and division em12 bracing the place where such action is pending. 

13 ‘‘(2) In this subsection, the terms ‘applicable eligible 

14 professional’, ‘health care liability action’, ‘health care or15 ganization’, and ‘health care provider’ have the meaning 

16 given such terms in section 10 of the Saving Lives, Saving 

17 Costs Act.’’. 

18 SEC. 9. MANDATORY REVIEW BY INDEPENDENT MEDICAL 

19 PANEL. 

20 (a) IN GENERAL.—If, in any health care liability ac21 tion removed to Federal court pursuant to section 1441(g) 

22 of title 28, United States Code, against an applicable eligi23 ble professional, health care provider, or health care orga24 nization, the applicable eligible professional, health care 

25 provider, or health care organization alleges, in response 


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1 to a filing of the claimant, that the applicable eligible pro2 fessional, health care provider, or health care organization 

3 adhered to an applicable clinical practice guideline in the 

4 provision of health care goods or services to the claimant, 

5 then the court shall suspend further proceedings on the 

6 health care liability action prior to discovery proceedings, 

7 until the completion of a review of the action by an inde8 pendent medical review panel. 

9 (b) INDEPENDENT MEDICAL REVIEW PANEL.— 

10 (1) COMPOSITION.—An independent medical re11 view panel under this section shall be composed of 

12 3 members who are experts in the relevant field of 

13 clinical practice, appointed in accordance with para14 graph (5). 

15 (2) REQUIREMENTS FOR MEMBER ELIGI16 BILITY.— 

17 (A) IN GENERAL.—To be eligible to serve 

18 on an independent medical review panel, a 

19 member shall— 

20 (i) be an experienced physician cer21 tified by a board recognized by the Amer22 ican Board of Medical Specialties or the 

23 American Osteopathic Association Bureau 

24 of Osteopathic Specialists; 


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1 (ii) not earlier than 2 years prior to 

2 the date of selection to the board, have 

3 been in active medical practice or devoted 

4 a substantial portion of his or her time to 

5 teaching at an accredited medical school, 

6 or have been engaged in university-based 

7 research in relation to the medical care 

8 and type of treatment at issue; and 

9 (iii) be approved by his or her spe10 cialty society. 

11 (B) REGIONAL PREFERENCE.—When pos12 sible, members should be from the region where 

13 the case in question originates to account for 

14 geographical practice variation. 

15 (3) NO CIVIL LIABILITY FOR MEMBERS.—No 

16 civil action shall be brought in any court against any 

17 member for any act, failure to act, or statement or 

18 opinion made, within the scope of his or her duties 

19 as a member of the independent medical review 

20 panel. 

21 (4) CONSIDERATIONS IN MAKING DETERMINA22 TIONS.—The members of the independent medical 

23 review panel shall acknowledge that, under certain 

24 circumstances, it may be appropriate for a physician 


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1 to depart from the recommendations in clinical prac2 tice guidelines in the care of individual patients. 

3 (5) SELECTION OF MEMBERS.—Each member 

4 of the independent medical review panel shall be 

5 jointly selected by the parties. A member whose se6 lection one party does not concur in may not serve 

7 on the panel, except that, if, not later than 30 days 

8 after a response to the health care liability action is 

9 filed, 3 members have not been selected by the par10 ties, the court shall appoint any remaining members. 

11 (6) COMPENSATION OF MEMBERS.—The costs 

12 of compensation to the members of the independent 

13 medical review panel shall be shared between the 

14 parties equally, unless otherwise agreed to by the 

15 parties. 

16 (c) TERMS OF REVIEW.—A review by an independent 

17 medical review panel under this section shall comply with 

18 the following: 

19 (1) STANDARD OF CONDUCT.—The mandatory 

20 independent medical review panel that is charged 

21 with the responsibility of making a preliminary find22 ing as to liability of the defendant applicable eligible 

23 professional shall deem the prescribed clinical prac24 tice guidelines as the standard of conduct, care, and 

25 skill expected of members of the medical profession 


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1 engaged in the defendant’s field of practice under 

2 the same or similar circumstances, subject to the 

3 provisions of subsection (b)(4). 

4 (2) RECORD FOR REVIEW.—The independent 

5 medical review panel shall make a preliminary find6 ing based solely upon the pre-discovery evidence sub7 mitted to it pursuant to Rule 26 of the Federal 

8 Rules of Civil Procedure, any medical records that 

9 would be discoverable if the lawsuit advances to 

10 trial, and the applicable prescribed clinical practice 

11 guidelines. 

12 (3) LIMITATION.—The independent medical re13 view panel shall not make a finding of negligence 

14 from the mere fact that a treatment or procedure 

15 was unsuccessful or failed to bring the best result, 

16 or that the patient died. 

17 (4) USE AT TRIAL OF WORK PRODUCT OF RE18 VIEW PANEL.—No preliminary finding by the inde19 pendent medical review panel that the defendant ap20 plicable eligible professional breached the standard 

21 of care as set forth under the prescribed clinical 

22 practice guidelines shall constitute negligence per se 

23 or conclusive evidence of liability, but findings, opin24 ions, and conclusions of the review panel shall be ad25 missible as evidence in any and all subsequent proVerDate Sep 11 2014 04:51 Mar 21, 2017 Jkt 069200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H1565.IH H1565

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1 ceedings before the court, including for purposes of 

2 motions for summary judgment and at trial. 

3 (d) RESULTS OF REVIEW.— 

4 (1) IN GENERAL.—Not later than 60 days after 

5 all members of the independent medical review panel 

6 have been selected, the panel shall complete a review 

7 of the record of the liability action and shall make 

8 a finding under this subsection. 

9 (2) FINDING DESCRIBED.—A finding under this 

10 subsection shall include the following: 

11 (A) A determination of whether there are 

12 any applicable clinical practice guidelines to the 

13 health care liability action that substantively 

14 pertains to the injury suffered by the claimant. 

15 (B) Whether the applicable eligible profes16 sional has alleged adherence to any such guide17 line. 

18 (C) Whether the applicable eligible profes19 sional adhered to any such guideline. 

20 (D) Whether there is a reasonable prob21 ability that— 

22 (i) the applicable eligible professional 

23 violated the applicable clinical practice 

24 guideline; 


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1 (ii) that violation proximately caused 

2 the claimant’s alleged injury; and 

3 (iii) the claimant suffered damages as 

4 a result of the injury. 

5 (3) USE AT TRIAL.—The finding under this 

6 subsection may be received into evidence by the 

7 court. If the independent medical review panel made 

8 any finding under paragraph (2)(D) that there was 

9 no reasonable probability of the matters described in 

10 clauses (i) through (iii), the court may issue a sum11 mary judgment in favor of the applicable eligible 

12 professional unless the claimant is able to show oth13 erwise by clear and convincing evidence. If the panel 

14 made a finding under subparagraphs (A) through 

15 (C) of paragraph (2) that there was an applicable 

16 clinical practice guideline that the defendant adhered 

17 to, the court shall issue summary judgment in favor 

18 of the applicable eligible professional unless the 

19 claimant is able to show otherwise by clear and con20 vincing evidence. Any preliminary finding that the 

21 defendant applicable eligible professional did not 

22 breach the standard of care as set forth under the 

23 prescribed medical practice guidelines or that the de24 fendant applicable eligible professional’s nonadher25 ence to the applicable standard was neither the 


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1 cause in fact nor the proximate cause of the plain2 tiff’s injury or that the plaintiff did not incur any 

3 damages as a result shall be given deference by the 

4 court and shall entitle the defendant applicable eligi5 ble professional to summary judgment unless the 

6 plaintiff is able to show by clear and convincing evi7 dence that the independent medical review panel was 

8 in error and that there is a genuine issue as to a 

9 material fact in the case. 

10 SEC. 10. DEFINITIONS. 

11 In this Act: 

12 (1) APPLICABLE ELIGIBLE PROFESSIONAL.— 

13 The term ‘‘applicable eligible professional’’ means a 

14 physician practicing within clinical practice guide15 lines submitted by an eligible professional organiza16 tion and includes employees and agents of a physi17 cian. 

18 (2) APPROPRIATE USE CRITERIA.—The term 

19 ‘‘appropriate use criteria’’ means established evi20 dence-based guidelines developed or endorsed by an 

21 eligible professional organization that specify when 

22 the health benefits of a procedure or service exceed 

23 the expected health risks by a significantly wide 

24 margin. 


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1 (3) CLINICAL PRACTICE GUIDELINE.—The term 

2 ‘‘clinical practice guideline’’ means systematically de3 veloped statements based on the review of clinical 

4 evidence for assisting a health care provider to de5 termine the appropriate health care in specific clin6 ical circumstances. 

7 (4) DIAGNOSTIC GUIDELINE.—The term ‘‘diag8 nostic guideline’’ means a clinical practice guideline 

9 that provides recommendation regarding the utility 

10 of diagnosis procedures for a specific clinical sce11 nario. 

12 (5) ELIGIBLE PROFESSIONAL ORGANIZATION.— 

13 The term ‘‘eligible professional organization’’ means 

14 a national or State medical society or medical spe15 cialty society. 

16 (6) FEDERAL PAYOR.—The term ‘‘Federal 

17 payor’’ includes reimbursements made under the 

18 Medicare program under title XVIII of the Social 

19 Security Act or the Medicaid program under title 

20 XIX of the Social Security Act, premium tax credits 

21 under section 36B of the Internal Revenue Code of 

22 1986 or cost-sharing reductions under section 1402 

23 of the Patient Protection and Affordable Care Act, 

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1 ices provided pursuant to section 1867 of the Social 

2 Security Act. 

3 (7) HEALTH CARE GOODS OR SERVICES.—The 

4 term ‘‘health care goods or services’’ means any 

5 goods or services provided by a health care organiza6 tion, provider, or by any individual working under 

7 the supervision of a health care provider, that relates 

8 to the diagnosis, prevention, or treatment of any 

9 human disease or impairment, or the assessment or 

10 care of the health of human beings. 

11 (8) HEALTH CARE LIABILITY ACTION.—The 

12 term ‘‘health care liability action’’ means a civil ac13 tion against an applicable eligible professional, a 

14 health care provider, or a health care organization, 

15 regardless of the theory of liability on which the 

16 claim is based, or the number of plaintiffs, defend17 ants, or other parties, or the number of causes of ac18 tion, in which the claimant alleges a health care li19 ability claim. 

20 (9) HEALTH CARE LIABILITY CLAIM.—The 

21 term ‘‘health care liability claim’’ means a claim by 

22 any person against an applicable eligible profes23 sional, a health care provider, or a health care orga24 nization which is based upon the provision of, use of, 

25 or payment for (or the failure to provide, use, or pay 


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1 for) health care goods or services for which at least 

2 partial payment was made by a Federal payor or 

3 which was mandated by Federal law, regardless of 

4 the theory of liability on which the claim is based. 

5 (10) HEALTH CARE ORGANIZATION.—The term 

6 ‘‘health care organization’’ means any person or en7 tity which is obligated to provide or pay for health 

8 benefits under any health plan, including any person 

9 or entity acting under a contract or arrangement 

10 with a health care organization to provide or admin11 ister any health benefit. 

12 (11) HEALTH CARE PROVIDER.—The term 

13 ‘‘health care provider’’ means any person or entity 

14 required by State or Federal laws or regulations to 

15 be licensed, registered, or certified to provide health 

16 care services, and being either so licensed, reg17 istered, or certified, or exempted from such require18 ment by other statute or regulation. 

19 (12) SECRETARY.—The term ‘‘Secretary’’ 

20 means the Secretary of Health and Human Services. 

Æ 


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