I 

113TH CONGRESS 

2D SESSION H. R. 4106 

To provide for the development and dissemination of clinical practice guidelines and the establishment of a right of removal to Federal courts 

for defendants in medical malpractice actions involving a Federal payor, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 27, 2014 

Mr. BARR (for himself and Mr. BERA of California) 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 development and dissemination of clinical 

practice guidelines and the establishment of a right of 

removal to Federal courts for defendants in medical malpractice actions involving a Federal payor, and for other 

purposes. 

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. PURPOSES. 

2 The purposes of this Act are: 

3 (1) To offer physicians who document adher4 ence to certain evidence-based clinical-practice guide5 lines, and, when applicable, appropriate use criteria, 

6 a safe harbor from medical-malpractice litigation. 

7 (2) To reduce the practice of defensive medicine 

8 and resulting health care costs. 

9 (3) To increase adherence to evidence-based 

10 clinical practice guidelines to reduce clinical vari11 ation in health care practice. 

12 (4) To improve quality of care and patient safe13 ty. 

14 (5) To permit organizations with relevant ex15 pertise to participate in the selection of clinical prac16 tice guidelines. 

17 (6) To permit professionals with relevant exper18 tise to participate and benefit from liability reform. 

19 SEC. 3. REQUIREMENTS FOR SELECTION OF CLINICAL 

20 PRACTICE GUIDELINES. 

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

22 date of enactment of this Act, eligible professional organi23 zations that have established, published, maintained and 

24 updated on a regular basis, clinical practice guidelines, in25 cluding when applicable, appropriate use criteria, that in26 corporate best practices, shall submit to the Secretary 


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1 those guidelines. Not later than 6 months after that sub2 mission date, the Secretary shall select and designate one 

3 or more of those eligible professional organizations to pro4 vide and maintain such clinical practice guidelines on be5 half of the Secretary. To this end, not more than 6 months 

6 after designating each such eligible professional organiza7 tion, the Secretary shall enter into an agreement with each 

8 such eligible professional organization for maintenance 

9 and updating of such clinical practice guidelines. 

10 (b) MAINTENANCE.— 

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

12 after publication of guidelines, and every five years 

13 thereafter, the Secretary shall review the clinical 

14 practice guidelines and shall, as necessary, enter into 

15 agreements with eligible professional organizations. 

16 (2) UPDATE BY ELIGIBLE PROFESSIONAL ORGA17 NIZATION.—An eligible professional organization 

18 that collaborated in the establishment of a clinical 

19 practice guideline may submit amendments to that 

20 clinical practice guideline at any time to the Sec21 retary, who shall review the amendments. 

22 (3) NOTIFICATION REQUIRED FOR CERTAIN UP23 DATES.—In the case of an amendment under para24 graph (2) that adds, materially changes, or removes 

25 a guideline from a set of guidelines, such update 


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1 shall not apply under this subsection unless notifica2 tion of such update is made available to applicable 

3 eligible professionals. 

4 SEC. 4. DEVELOPMENT. 

5 (a) GUIDELINE STANDARDS.—To the extent possible, 

6 the development of clinical practice guidelines should be 

7 guided by the Institute of Medicine’s Standards for Devel8 oping Trustworthy Guidelines and should— 

9 (1) be developed through a transparent process 

10 that minimizes conflicts of interest; 

11 (2) be developed by a knowledgeable, multidisci12 plinary panel of experts and representatives from 

13 key affected groups; 

14 (3) take into consideration important patient 

15 subgroups and patient preferences as appropriate; 

16 (4) be based on a systematic review of the exist17 ing evidence; 

18 (5) provide a clear explanation of the relation19 ship between care options and health outcomes; 

20 (6) provide ratings of both the quality of evi21 dence and strength of recommendation; 

22 (7) be reconsidered and revised when new evi23 dence emerges; and 

24 (8) clearly identify any exceptions to the appli25 cation of the clinical practice guideline. 


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1 (b) REQUIRED DISCLOSURES FROM ELIGIBLE PRO2 FESSIONAL ORGANIZATIONS.—Any person who is affili3 ated with an eligible professional organization and who di4 rectly participated in the creation of a clinical practice 

5 guideline shall disclose any conflicts of interest pertaining 

6 to the development of the clinical practice guideline, in7 cluding any conflict of interest pertaining to any instru8 ment, medicine, drug, or any other substance, device, or 

9 means included in the clinical practice guideline. Disclo10 sures by eligible professional organizations shall be made 

11 promptly, upon submission of the guidelines, and during 

12 every review of the guidelines, to the Secretary. Disclo13 sures shall additionally include the following: 

14 (1) Scientific methodology and evidence that 

15 supports clinical practice guidelines. 

16 (2) Outside collaborators. 

17 (3) Endorsements. 

18 SEC. 5. INTERNET PUBLICATION OF GUIDELINES. 

19 The Secretary of Health and Human Services shall 

20 publish all clinical practice guidelines on the Internet 

21 through the National Guideline Clearinghouse or other ap22 propriate sites or sources, including all data and method23 ology used in the development and selection of the guide24 lines in compliance with data disclosure standards in the 


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1 Health Insurance Portability and Accountability Act of 

2 1996. 

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

4 RIGHTS. 

5 (a) LIMITATION.—This Act shall not preempt or su6 persede any State or Federal law that imposes greater 

7 procedural or substantive protections for health care pro8 viders and health care organizations from liability, loss, 

9 or damages than those provided by this title or create a 

10 cause of action. 

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

12 shall be construed to preempt any defense available to a 

13 party in a health care liability action under any other pro14 vision of State or Federal law. 

15 SEC. 7. RIGHT OF REMOVAL. 

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

17 amended by adding at the end the following: 

18 ‘‘(g) CERTAIN ACTIONS AGAINST MEDICAL PROFES19 SIONALS.—(1) Any health care liability action brought in 

20 a State court against an applicable eligible professional or 

21 health care provider may be removed by any defendant 

22 or the defendants to the district court of the United States 

23 for the district and division embracing the place where 

24 such action is pending. 


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1 ‘‘(2) For purposes of this subsection the terms ‘appli2 cable eligible professional’, ‘health care provider’, ‘health 

3 care liability action’, and ‘health care liability claim’ have 

4 the meaning given such term in section 10 of the Saving 

5 Lives, Saving Costs Act of 2014.’’. 

6 SEC. 8. MANDATORY REVIEW BY INDEPENDENT MEDICAL 

7 REVIEW PANEL. 

8 (a) IN GENERAL.—If, in any health care liability ac9 tion against an applicable eligible professional, the appli10 cable eligible professional alleges, in any response to the 

11 claimant’s filing, that the applicable eligible professional 

12 adhered to an applicable clinical practice guideline in the 

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

14 then the court shall suspend further proceedings on the 

15 health care liability action prior to discovery proceedings, 

16 until the completion of a review of the action by an inde17 pendent medical review panel. 

18 (b) INDEPENDENT MEDICAL REVIEW PANEL.— 

19 (1) COMPOSITION.—An independent medical re20 view panel under this section shall be composed of 

21 3 members who are experts in the relevant field of 

22 clinical practice. 

23 (2) REQUIREMENTS FOR MEMBER ELIGI24 BILITY.—To be eligible to serve on an independent 

25 medical review panel, a member shall— 


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1 (A) be an experienced physician certified 

2 by a board recognized by the American Board 

3 of Medical Specialties; 

4 (B) not earlier than 2 years prior to the 

5 date of selection to the board, have been in ac6 tive medical practice or devoted a substantial 

7 portion of his or her time to teaching at an ac8 credited medical school, or have been engaged 

9 in university-based research in relation to the 

10 medical care and type of treatment at issue; 

11 and 

12 (C) be approved by his or her specialty so13 ciety. 

14 When possible, members should be from the region 

15 where the case in question originates to account for 

16 geographical practice variation. 

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

18 civil action shall be brought in any court against any 

19 member for any act done, failure to act, or state20 ment or opinion made, within the scope of his or her 

21 duties as a member of the independent medical re22 view panel. 

23 (4) CONSIDERATIONS IN MAKING DETERMINA24 TIONS.—The members of the independent medical 

25 review panel shall acknowledge the ability of physiVerDate Mar 15 2010 04:27 Feb 28, 2014 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4106.IH H4106

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1 cians to depart from the recommendations in clinical 

2 practice guidelines, when appropriate, in the care of 

3 individual patients. 

4 (5) SELECTION OF MEMBERS.—Each member 

5 of the panel shall be jointly selected by the parties. 

6 A member whose selection one party does not concur 

7 in may not serve on the panel, except that, if, not 

8 later than 30 days after a response to the health 

9 care liability action is filed, 3 members have not 

10 been selected by the parties, the court shall appoint 

11 any remaining members. 

12 (6) COMPENSATION OF MEMBERS.—The costs 

13 of compensation to the members of the panel shall 

14 be split between the parties equally, unless otherwise 

15 agreed to by the 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. 

3 (2) RECORD FOR REVIEW.—The review panel 

4 shall make a preliminary finding based solely upon 

5 the pre-discovery evidence submitted to it pursuant 

6 to Rule 26 of the Federal Rules of Civil Procedure 

7 and the applicable prescribed clinical practice guide8 lines. 

9 (3) LIMITATION.—The review panel shall not 

10 make a finding of negligence from the mere fact that 

11 a treatment or procedure was unsuccessful, failed to 

12 bring the best result or that the patient died. 

13 (4) USE AT TRIAL OF WORK PRODUCT OF RE14 VIEW PANEL.—No preliminary finding by the review 

15 panel that the defendant applicable eligible profes16 sional breached the standard of care as set forth 

17 under the prescribed clinical practice guidelines shall 

18 constitute negligence per se or conclusive evidence of 

19 liability. However, said findings, opinions and con20 clusions of the review panel shall be admissible as 

21 evidence in any and all subsequent proceedings be22 fore the court, including for purposes of motions for 

23 summary judgment and at trial. 

24 (d) RESULTS OF REVIEW.— 


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

2 all members of the panel have been selected, the 

3 panel shall complete a review of the record of the li4 ability action and shall make a finding under this 

5 subsection. 

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

7 subsection shall include the following: 

8 (A) A determination of whether or not 

9 there are any applicable clinical practice guide10 lines to the health care liability action that sub11 stantively pertains to the injury suffered by the 

12 claimant. 

13 (B) If the applicable eligible professional 

14 has alleged adherence to any such guideline. 

15 (C) If the applicable eligible professional 

16 did adhere to any such guideline. 

17 (D) Whether there is a reasonable prob18 ability that— 

19 (i) the applicable eligible professional 

20 violated the applicable standard of care; 

21 (ii) that violation proximately caused 

22 the claimant’s alleged injury; and 

23 (iii) the claimant suffered damages as 

24 a result of the injury. 


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

2 subsection may be received into evidence by the 

3 court. If the panel made any finding under para4 graph (2)(D) that there was no reasonable prob5 ability, the court may issue a summary judgment in 

6 favor of the applicable eligible professional unless 

7 the claimant is able to show otherwise by clear and 

8 convincing evidence. If the panel made a finding 

9 under subparagraphs (A) through (C) that there was 

10 an applicable clinical practice guideline that the de11 fendant adhered to, the court shall issue summary 

12 judgment in favor of the applicable eligible profes13 sional unless the claimant is able to show otherwise 

14 by clear and convincing evidence. Any preliminary 

15 finding that the defendant applicable eligible profes16 sional did not breach the standard of care as set 

17 forth under the prescribed medical practice guide18 lines or that the defendant applicable eligible profes19 sional’s failure to conform to the required standard 

20 was neither the cause in fact nor the proximate 

21 cause of the plaintiff’s injury or that the plaintiff 

22 did not incur any damages as a result shall be given 

23 deference by the court and shall entitle the defend24 ant applicable eligible professional to summary judg25 ment unless the plaintiff is able to show by clear and 


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1 convincing evidence that the independent medical re2 view panel was in error and that there is a genuine 

3 issue as to a material fact in the case. 

4 SEC. 9. RECOVERY OF COSTS. 

5 If the defendant applicable eligible professional pre6 vails subsequent to a preliminary finding in his or her 

7 favor by the independent medical review panel, the defend8 ant may recover costs and attorneys’ fees from the plain9 tiff. 

10 SEC. 10. DEFINITIONS. 

11 In this Act: 

12 (1) APPLICABLE ELIGIBLE PROFESSIONAL.— 

13 The term ‘‘applicable eligible professional’’ means 

14 physicians 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 

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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 a health care provider or a health care 

9 organization, regardless of the theory of liability on 

10 which the claim is based, or the number of plaintiffs, 

11 defendants, or other parties, or the number of 

12 causes of action, in which the claimant alleges a 

13 health care liability claim. 

14 (8) HEALTH CARE LIABILITY CLAIM.—The 

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

16 any person against a health care provider or a 

17 health care organization which is based upon the 

18 provision of, use of, or payment for (or the failure 

19 to provide, use, or pay for) health care goods serv20 ices for which at least partial payment was made by 

21 a Federal payor or which was mandated by Federal 

22 law, regardless of the theory of liability on which the 

23 claim is based. 

24 (9) HEALTH CARE ORGANIZATION.—The term 

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1 tity which is obligated to provide or pay for health 

2 benefits under any health plan, including any person 

3 or entity acting under a contract or arrangement 

4 with a health care organization to provide or admin5 ister any health benefit. 

6 (10) HEALTH CARE PROVIDER.—The term 

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

8 required by State or Federal laws or regulations to 

9 be licensed, registered, or certified to provide health 

10 care services, and being either so licensed, reg11 istered, or certified, or exempted from such require12 ment by other statute or regulation. 

13 (11) PERFORMANCE PERIOD.—The term ‘‘per14 formance period’’ means the period of time during 

15 which the final rule establishing a clinical practice 

16 guideline is in effect. 

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

18 means the Secretary of Health and Human Services. 

Æ 


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