I 

114TH CONGRESS 

1ST SESSION H. R. 2603 

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 

JUNE 2, 2015 

Mr. BARR (for himself and Mr. ROE of Tennessee) 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 06:10 Jun 03, 2015 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2603.IH H2603

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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) provide a clear explanation of the relation6 ship between care options and health outcomes; 

7 (6) provide ratings of both the quality of evi8 dence and strength of recommendation; 

9 (7) are reconsidered and revised when new evi10 dence emerges; and 

11 (8) clearly identify any exceptions to the appli12 cation of the clinical practice guideline. 

13 (b) REQUIRED DISCLOSURES FROM ELIGIBLE PRO14 FESSIONAL ORGANIZATIONS.—Any person who is affili15 ated with an eligible professional organization and who di16 rectly participated in the creation of a clinical practice 

17 guideline shall disclose any conflicts of interest pertaining 

18 to the development of the clinical practice guideline, in19 cluding any conflict of interest pertaining to any instru20 ment, medicine, drug, or any other substance, device, or 

21 means included in the clinical practice guideline. Disclo22 sures to the Secretary by eligible professional organiza23 tions shall be made promptly, upon submission of the 

24 guidelines, and during every review of the guidelines. Dis25 closures shall include the following: 


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1 (1) Scientific methodology and evidence that 

2 supports clinical practice guidelines. 

3 (2) Outside collaborators. 

4 (3) Endorsements. 

5 SEC. 4. NO LIABILITY FOR GUIDELINE PRODUCERS. 

6 Neither an eligible professional organization nor the 

7 participants in its guideline development and approval 

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

9 caused by adhering to a clinical practice guideline to which 

10 they contributed. 

11 SEC. 5. INTERNET PUBLICATION OF GUIDELINES. 

12 The Secretary shall publish on the Internet through 

13 the National Guideline Clearinghouse or other appropriate 

14 sites or sources, all clinical practice guidelines, including 

15 all data and methodology used in the development and se16 lection of the guidelines in compliance with data disclosure 

17 standards in the Health Insurance Portability and Ac18 countability Act of 1996 (Public Law 104–191). 

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

20 RIGHTS. 

21 (a) LIMITATION.—This Act shall not preempt or su22 persede any State or Federal law that— 

23 (1) imposes procedural or substantive protec24 tions for health care providers and health care orgaVerDate Sep 11 2014 06:10 Jun 03, 2015 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2603.IH H2603

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1 nizations from liability, loss, or damages greater 

2 than such protections provided by this title; or 

3 (2) creates a cause of action related to the pro4 vision of health care goods or services. 

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

6 shall be construed to preempt any defense available to a 

7 party in a health care liability action under any other pro8 vision of State or Federal law. 

9 SEC. 7. FEDERAL CAUSE OF ACTION. 

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

11 States Code, is amended by adding at the end the fol12 lowing: 

13 ‘‘§ 1370. Health care liability claims 

14 ‘‘(a) DEFINITIONS.—In this section, the terms ‘appli15 cable eligible professional’, ‘health care goods or services’, 

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

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

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

19 Lives, Saving Costs Act. 

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

21 shall have original jurisdiction of a health care liability ac22 tion against an applicable eligible professional, health care 

23 provider, or health care organization. 

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

25 decision in a health care liability action brought under 


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

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

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

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

5 the health care liability claim occurred unless such law is 

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

7 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

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

9 States Code, is amended by adding at the end the fol10 lowing: 

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

11 SEC. 8. RIGHT OF REMOVAL. 

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

13 amended by adding at the end the following: 

14 ‘‘(g) CERTAIN ACTIONS AGAINST MEDICAL PROFES15 SIONALS.—(1) A health care liability action brought in a 

16 State court against an applicable eligible professional, 

17 health care provider, or health care organization may be 

18 removed by any defendant or the defendants to the district 

19 court of the United States for the district and division em20 bracing the place where such action is pending. 

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

22 professional’, ‘health care liability action’, ‘health care or23 ganization’, and ‘health care provider’ have the meaning 

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

25 Costs Act.’’. 


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1 SEC. 9. MANDATORY REVIEW BY INDEPENDENT MEDICAL 

2 PANEL. 

3 (a) IN GENERAL.—If, in any health care liability ac4 tion removed to Federal court pursuant to section 1441(g) 

5 of title 28, United States Code, against an applicable eligi6 ble professional, health care provider, or health care orga7 nization, the applicable eligible professional, health care 

8 provider, or health care organization alleges, in response 

9 to a filing of the claimant, that the applicable eligible pro10 fessional, health care provider, or health care organization 

11 adhered to an applicable clinical practice guideline in the 

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

13 then the court shall suspend further proceedings on the 

14 health care liability action prior to discovery proceedings, 

15 until the completion of a review of the action by an inde16 pendent medical review panel. 

17 (b) INDEPENDENT MEDICAL REVIEW PANEL.— 

18 (1) COMPOSITION.—An independent medical re19 view panel under this section shall be composed of 

20 3 members who are experts in the relevant field of 

21 clinical practice, appointed in accordance with para22 graph (5). 

23 (2) REQUIREMENTS FOR MEMBER ELIGI24 BILITY.— 


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

2 on an independent medical review panel, a 

3 member shall— 

4 (i) be an experienced physician cer5 tified by a board recognized by the Amer6 ican Board of Medical Specialties; 

7 (ii) not earlier than 2 years prior to 

8 the date of selection to the board, have 

9 been in active medical practice or devoted 

10 a substantial portion of his or her time to 

11 teaching at an accredited medical school, 

12 or have been engaged in university-based 

13 research in relation to the medical care 

14 and type of treatment at issue; and 

15 (iii) be approved by his or her spe16 cialty society. 

17 (B) REGIONAL PREFERENCE.—When pos18 sible, members should be from the region where 

19 the case in question originates to account for 

20 geographical practice variation. 

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

22 civil action shall be brought in any court against any 

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

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


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1 as a member of the independent medical review 

2 panel. 

3 (4) CONSIDERATIONS IN MAKING DETERMINA4 TIONS.—The members of the independent medical 

5 review panel shall acknowledge that, under certain 

6 circumstances, it may be appropriate for a physician 

7 to depart from the recommendations in clinical prac8 tice guidelines in the care of individual patients. 

9 (5) SELECTION OF MEMBERS.—Each member 

10 of the independent medical review panel shall be 

11 jointly selected by the parties. A member whose se12 lection one party does not concur in may not serve 

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

14 after a response to the health care liability action is 

15 filed, 3 members have not been selected by the par16 ties, the court shall appoint any remaining members. 

17 (6) COMPENSATION OF MEMBERS.—The costs 

18 of compensation to the members of the independent 

19 medical review panel shall be shared between the 

20 parties equally, unless otherwise agreed to by the 

21 parties. 

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

23 medical review panel under this section shall comply with 

24 the following: 


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1 (1) STANDARD OF CONDUCT.—The mandatory 

2 independent medical review panel that is charged 

3 with the responsibility of making a preliminary find4 ing as to liability of the defendant applicable eligible 

5 professional shall deem the prescribed clinical prac6 tice guidelines as the standard of conduct, care, and 

7 skill expected of members of the medical profession 

8 engaged in the defendant’s field of practice under 

9 the same or similar circumstances, subject to the 

10 provisions of subsection (b)(4). 

11 (2) RECORD FOR REVIEW.—The independent 

12 medical review panel shall make a preliminary find13 ing based solely upon the pre-discovery evidence sub14 mitted to it pursuant to Rule 26 of the Federal 

15 Rules of Civil Procedure, any medical records that 

16 would be discoverable if the lawsuit advances to 

17 trial, and the applicable prescribed clinical practice 

18 guidelines. 

19 (3) LIMITATION.—The independent medical re20 view panel shall not make a finding of negligence 

21 from the mere fact that a treatment or procedure 

22 was unsuccessful or failed to bring the best result, 

23 or that the patient died. 

24 (4) USE AT TRIAL OF WORK PRODUCT OF RE25 VIEW PANEL.—No preliminary finding by the indeVerDate Sep 11 2014 06:10 Jun 03, 2015 Jkt 049200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H2603.IH H2603

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1 pendent medical review panel that the defendant ap2 plicable eligible professional breached the standard 

3 of care as set forth under the prescribed clinical 

4 practice guidelines shall constitute negligence per se 

5 or conclusive evidence of liability, but findings, opin6 ions, and conclusions of the review panel shall be ad7 missible as evidence in any and all subsequent pro8 ceedings before the court, including for purposes of 

9 motions for summary judgment and at trial. 

10 (d) RESULTS OF REVIEW.— 

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

12 all members of the independent medical review panel 

13 have been selected, the panel shall complete a review 

14 of the record of the liability action and shall make 

15 a finding under this subsection. 

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

17 subsection shall include the following: 

18 (A) A determination of whether there are 

19 any applicable clinical practice guidelines to the 

20 health care liability action that substantively 

21 pertains to the injury suffered by the claimant. 

22 (B) Whether the applicable eligible profes23 sional has alleged adherence to any such guide24 line. 


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1 (C) Whether the applicable eligible profes2 sional adhered to any such guideline. 

3 (D) Whether there is a reasonable prob4 ability that— 

5 (i) the applicable eligible professional 

6 violated the applicable clinical practice 

7 guideline; 

8 (ii) that violation proximately caused 

9 the claimant’s alleged injury; and 

10 (iii) the claimant suffered damages as 

11 a result of the injury. 

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

13 subsection may be received into evidence by the 

14 court. If the independent medical review panel made 

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

16 no reasonable probability of the matters described in 

17 clauses (i) through (iii), the court may issue a sum18 mary judgment in favor of the applicable eligible 

19 professional unless the claimant is able to show oth20 erwise by clear and convincing evidence. If the panel 

21 made a finding under subparagraphs (A) through 

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

23 clinical practice guideline that the defendant adhered 

24 to, the court shall issue summary judgment in favor 

25 of the applicable eligible professional unless the 


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1 claimant is able to show otherwise by clear and con2 vincing evidence. Any preliminary finding that the 

3 defendant applicable eligible professional did not 

4 breach the standard of care as set forth under the 

5 prescribed medical practice guidelines or that the de6 fendant applicable eligible professional’s nonadher7 ence to the applicable standard was neither the 

8 cause in fact nor the proximate cause of the plain9 tiff’s injury or that the plaintiff did not incur any 

10 damages as a result shall be given deference by the 

11 court and shall entitle the defendant applicable eligi12 ble professional to summary judgment unless the 

13 plaintiff is able to show by clear and convincing evi14 dence that the independent medical review panel was 

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

16 material fact in the case. 

17 SEC. 10. DEFINITIONS. 

18 In this Act: 

19 (1) APPLICABLE ELIGIBLE PROFESSIONAL.— 

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

21 physician practicing within clinical practice guide22 lines submitted by an eligible professional organiza23 tion and includes employees and agents of a physi24 cian. 


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1 (2) APPROPRIATE USE CRITERIA.—The term 

2 ‘‘appropriate use criteria’’ means established evi3 dence-based guidelines developed or endorsed by an 

4 eligible professional organization that specify when 

5 the health benefits of a procedure or service exceed 

6 the expected health risks by a significantly wide 

7 margin. 

8 (3) CLINICAL PRACTICE GUIDELINE.—The term 

9 ‘‘clinical practice guideline’’ means systematically de10 veloped statements based on the review of clinical 

11 evidence for assisting a health care provider to de12 termine the appropriate health care in specific clin13 ical circumstances. 

14 (4) ELIGIBLE PROFESSIONAL ORGANIZATION.— 

15 The term ‘‘eligible professional organization’’ means 

16 a national or State medical society or medical spe17 cialty society. 

18 (5) FEDERAL PAYOR.—The term ‘‘Federal 

19 payor’’ includes reimbursements made under the 

20 Medicare program under title XVIII of the Social 

21 Security Act or the Medicaid program under title 

22 XIX of the Social Security Act, premium tax credits 

23 under section 36B of the Internal Revenue Code of 

24 1986 or cost-sharing reductions under section 1402 

25 of the Patient Protection and Affordable Care Act, 


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1 or medical screenings, treatments, or transfer serv2 ices provided pursuant to section 1867 of the Social 

3 Security Act is not made by the individual or any 

4 non-Federal third party on behalf of the individual. 

5 (6) HEALTH CARE GOODS OR SERVICES.—The 

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

7 goods or services provided by a health care organiza8 tion, provider, or by any individual working under 

9 the supervision of a health care provider, that relates 

10 to the diagnosis, prevention, or treatment of any 

11 human disease or impairment, or the assessment or 

12 care of the health of human beings. 

13 (7) HEALTH CARE LIABILITY ACTION.—The 

14 term ‘‘health care liability action’’ means a civil ac15 tion against an applicable eligible professional, a 

16 health care provider, or a health care organization, 

17 regardless of the theory of liability on which the 

18 claim is based, or the number of plaintiffs, defend19 ants, or other parties, or the number of causes of ac20 tion, in which the claimant alleges a health care li21 ability claim. 

22 (8) HEALTH CARE LIABILITY CLAIM.—The 

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

24 any person against an applicable eligible profes25 sional, a health care provider, or a health care orgaVerDate Sep 11 2014 06:10 Jun 03, 2015 Jkt 049200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H2603.IH H2603

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1 nization which is based upon the provision of, use of, 

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

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

4 partial payment was made by a Federal payor or 

5 which was mandated by Federal law, regardless of 

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

7 (9) HEALTH CARE ORGANIZATION.—The term 

8 ‘‘health care organization’’ means any person or en9 tity which is obligated to provide or pay for health 

10 benefits under any health plan, including any person 

11 or entity acting under a contract or arrangement 

12 with a health care organization to provide or admin13 ister any health benefit. 

14 (10) HEALTH CARE PROVIDER.—The term 

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

16 required by State or Federal laws or regulations to 

17 be licensed, registered, or certified to provide health 

18 care services, and being either so licensed, reg19 istered, or certified, or exempted from such require20 ment by other statute or regulation. 

21 (11) SECRETARY.—The term ‘‘Secretary’’ 

22 means the Secretary of Health and Human Services. 

Æ 


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