II 

114TH CONGRESS 

1ST SESSION S. 1475 

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

malpractice actions who demonstrate adherence to clinical practice guidelines. 

IN THE SENATE OF THE UNITED STATES 

JUNE 2, 2015 

Mr. BARRASSO (for himself and Mrs. CAPITO) introduced the following bill; 

which was read twice and referred to the Committee on the Judiciary 

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’’. 

6 SEC. 2. REQUIREMENTS FOR SELECTION OF CLINICAL 

7 PRACTICE GUIDELINES. 

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

9 date of enactment of this Act, eligible professional organi10 zations that have established, published, maintained, and 


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1 updated on a regular basis, clinical practice guidelines, in2 cluding when applicable, appropriate use criteria, that in3 corporate best practices, may submit such guidelines to 

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

5 for submitting such guidelines, the Secretary shall select 

6 and designate one or more eligible professional organiza7 tions to provide and maintain such clinical practice guide8 lines on behalf of the Secretary. Not later than 6 months 

9 after designating each such eligible professional organiza10 tion, the Secretary shall enter into an agreement with each 

11 such eligible professional organization for maintenance, 

12 publication, and updating of such clinical practice guide13 lines. 

14 (b) MAINTENANCE.— 

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

16 after the Secretary enters into an agreement with 

17 each eligible professional organization under sub18 section (a), and every 5 years thereafter, the Sec19 retary shall review the clinical practice guidelines of 

20 such organization and shall, as necessary, enter into 

21 agreements with additional eligible professional orga22 nizations, as appropriate, in accordance with sub23 section (a). 

24 (2) UPDATE BY ELIGIBLE PROFESSIONAL ORGA25 NIZATION.—An eligible professional organization 


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1 that collaborated in the establishment of a clinical 

2 practice guideline may submit amendments to that 

3 clinical practice guideline at any time to the Sec4 retary for review by the Secretary. 

5 (3) NOTIFICATION REQUIRED FOR CERTAIN UP6 DATES.—An amendment under paragraph (2) may 

7 not add, materially change, or remove a guideline 

8 from a set of guidelines, unless notification of such 

9 update is made available to applicable eligible profes10 sionals. 

11 SEC. 3. DEVELOPMENT. 

12 (a) GUIDELINE STANDARDS.—The Secretary shall 

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

14 clinical practice guidelines are guided by the Standards 

15 for Developing Trustworthy Clinical Practice Guidelines of 

16 the Institute of Medicine and— 

17 (1) are developed through a transparent process 

18 that minimizes conflicts of interest; 

19 (2) are developed by a knowledgeable, multi20 disciplinary panel of experts and representatives 

21 from key affected groups; 

22 (3) take into consideration important patient 

23 subgroups and patient preferences, as appropriate; 

24 (4) are based on a systematic review of the ex25 isting evidence; 


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1 (5) provide a clear explanation of the relation2 ship between care options and health outcomes; 

3 (6) provide ratings of both the quality of evi4 dence and strength of recommendation; 

5 (7) are reconsidered and revised when new evi6 dence emerges; and 

7 (8) clearly identify any exceptions to the appli8 cation of the clinical practice guideline. 

9 (b) REQUIRED DISCLOSURES FROM ELIGIBLE PRO10 FESSIONAL ORGANIZATIONS.—Any person who is affili11 ated with an eligible professional organization and who di12 rectly participated in the creation of a clinical practice 

13 guideline shall disclose any conflicts of interest pertaining 

14 to the development of the clinical practice guideline, in15 cluding any conflict of interest pertaining to any instru16 ment, medicine, drug, or any other substance, device, or 

17 means included in the clinical practice guideline. Disclo18 sures to the Secretary by eligible professional organiza19 tions shall be made promptly, upon submission of the 

20 guidelines, and during every review of the guidelines. Dis21 closures shall include the following: 

22 (1) Scientific methodology and evidence that 

23 supports clinical practice guidelines. 

24 (2) Outside collaborators. 

25 (3) Endorsements. 


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1 SEC. 4. NO LIABILITY FOR GUIDELINE PRODUCERS. 

2 Neither an eligible professional organization nor the 

3 participants in its guideline development and approval 

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

5 caused by adhering to a clinical practice guideline to which 

6 they contributed. 

7 SEC. 5. INTERNET PUBLICATION OF GUIDELINES. 

8 The Secretary shall publish on the Internet through 

9 the National Guideline Clearinghouse or other appropriate 

10 sites or sources, all clinical practice guidelines, including 

11 all data and methodology used in the development and se12 lection of the guidelines in compliance with data disclosure 

13 standards in the Health Insurance Portability and Ac14 countability Act of 1996 (Public Law 104–191). 

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

16 RIGHTS. 

17 (a) LIMITATION.—This Act shall not preempt or su18 persede any State or Federal law that— 

19 (1) imposes procedural or substantive protec20 tions for health care providers and health care orga21 nizations from liability, loss, or damages greater 

22 than such protections provided by this title; or 

23 (2) creates a cause of action related to the pro24 vision of health care goods or services. 

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

26 shall be construed to preempt any defense available to a 


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1 party in a health care liability action under any other pro2 vision of State or Federal law. 

3 SEC. 7. FEDERAL CAUSE OF ACTION. 

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

5 States Code, is amended by adding at the end the fol6 lowing: 

7 ‘‘§ 1370. Health care liability claims 

8 ‘‘(a) DEFINITIONS.—In this section, the terms ‘appli9 cable eligible professional’, ‘health care goods or services’, 

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

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

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

13 Lives, Saving Costs Act. 

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

15 shall have original jurisdiction of a health care liability ac16 tion against an applicable eligible professional, health care 

17 provider, or health care organization. 

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

19 decision in a health care liability action brought under 

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

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

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

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

24 the health care liability claim occurred unless such law is 

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


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1 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

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

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

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

5 SEC. 8. RIGHT OF REMOVAL. 

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

7 amended by adding at the end the following: 

8 ‘‘(g) CERTAIN ACTIONS AGAINST MEDICAL PROFES9 SIONALS.—(1) A health care liability action brought in a 

10 State court against an applicable eligible professional, 

11 health care provider, or health care organization may be 

12 removed by any defendant or the defendants to the district 

13 court of the United States for the district and division em14 bracing the place where such action is pending. 

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

16 professional’, ‘health care liability action’, ‘health care or17 ganization’, and ‘health care provider’ have the meaning 

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

19 Costs Act.’’. 

20 SEC. 9. MANDATORY REVIEW BY INDEPENDENT MEDICAL 

21 PANEL. 

22 (a) IN GENERAL.—If, in any health care liability ac23 tion removed to Federal court pursuant to section 1441(g) 

24 of title 28, United States Code, against an applicable eligi25 ble professional, health care provider, or health care orgaVerDate Sep 11 2014 01:13 Jun 03, 2015 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1475.IS S1475

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1 nization, the applicable eligible professional, health care 

2 provider, or health care organization alleges, in response 

3 to a filing of the claimant, that the applicable eligible pro4 fessional, health care provider, or health care organization 

5 adhered to an applicable clinical practice guideline in the 

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

7 then the court shall suspend further proceedings on the 

8 health care liability action prior to discovery proceedings, 

9 until the completion of a review of the action by an inde10 pendent medical review panel. 

11 (b) INDEPENDENT MEDICAL REVIEW PANEL.— 

12 (1) COMPOSITION.—An independent medical re13 view panel under this section shall be composed of 

14 3 members who are experts in the relevant field of 

15 clinical practice, appointed in accordance with para16 graph (5). 

17 (2) REQUIREMENTS FOR MEMBER ELIGI18 BILITY.— 

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

20 on an independent medical review panel, a 

21 member shall— 

22 (i) be an experienced physician cer23 tified by a board recognized by the Amer24 ican Board of Medical Specialties; 


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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 01:13 Jun 03, 2015 Jkt 049200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1475.IS S1475

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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) ELIGIBLE PROFESSIONAL ORGANIZATION.— 

8 The term ‘‘eligible professional organization’’ means 

9 a national or State medical society or medical spe10 cialty society. 

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

12 payor’’ includes reimbursements made under the 

13 Medicare program under title XVIII of the Social 

14 Security Act or the Medicaid program under title 

15 XIX of the Social Security Act, premium tax credits 

16 under section 36B of the Internal Revenue Code of 

17 1986 or cost-sharing reductions under section 1402 

18 of the Patient Protection and Affordable Care Act, 

19 or medical screenings, treatments, or transfer serv20 ices provided pursuant to section 1867 of the Social 

21 Security Act is not made by the individual or any 

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

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

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

25 goods or services provided by a health care organizaVerDate Sep 11 2014 01:13 Jun 03, 2015 Jkt 049200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S1475.IS S1475

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1 tion, provider, or by any individual working under 

2 the supervision of a health care provider, that relates 

3 to the diagnosis, prevention, or treatment of any 

4 human disease or impairment, or the assessment or 

5 care of the health of human beings. 

6 (7) HEALTH CARE LIABILITY ACTION.—The 

7 term ‘‘health care liability action’’ means a civil ac8 tion against an applicable eligible professional, a 

9 health care provider, or a health care organization, 

10 regardless of the theory of liability on which the 

11 claim is based, or the number of plaintiffs, defend12 ants, or other parties, or the number of causes of ac13 tion, in which the claimant alleges a health care li14 ability claim. 

15 (8) HEALTH CARE LIABILITY CLAIM.—The 

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

17 any person against an applicable eligible profes18 sional, a health care provider, or a health care orga19 nization which is based upon the provision of, use of, 

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

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

22 partial payment was made by a Federal payor or 

23 which was mandated by Federal law, regardless of 

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


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1 (9) HEALTH CARE ORGANIZATION.—The term 

2 ‘‘health care organization’’ means any person or en3 tity which is obligated to provide or pay for health 

4 benefits under any health plan, including any person 

5 or entity acting under a contract or arrangement 

6 with a health care organization to provide or admin7 ister any health benefit. 

8 (10) HEALTH CARE PROVIDER.—The term 

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

10 required by State or Federal laws or regulations to 

11 be licensed, registered, or certified to provide health 

12 care services, and being either so licensed, reg13 istered, or certified, or exempted from such require14 ment by other statute or regulation. 

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

16 means the Secretary of Health and Human Services. 

Æ 


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