II 

111TH CONGRESS 

1ST SESSION S. 1133 

To amend title XVIII of the Social Security Act to provide for the establishment of shared decision making standards and requirements and to 

establish a pilot program for the implementation of shared decision 

making under the Medicare program. 

IN THE SENATE OF THE UNITED STATES 

MAY 21, 2009 

Mr. WYDEN (for himself and Mr. GREGG) introduced the following bill; which 

was read twice and referred to the Committee on Finance 

A BILL 

To amend title XVIII of the Social Security Act to provide 

for the establishment of shared decision making standards and requirements and to establish a pilot program 

for the implementation of shared decision making under 

the Medicare program. 

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 ‘‘Empowering Medicare 

5 Patient Choices Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 


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1 (1) The Dartmouth Atlas Project’s work docu2 menting regional variations in medical care has 

3 found both underuse, or the failure to deliver needed 

4 evidence-based care, and overuse, or the delivery of 

5 unnecessary supply-sensitive care. 

6 (2) The Dartmouth Atlas Project has also 

7 found that many clinical decisions physicians make 

8 for elective medical treatments are driven by local 

9 medical opinion, rather than sound science or the 

10 preferences of well-informed patients. For example, 

11 the Dartmouth Atlas Project found that, among the 

12 306 Hospital Referral Regions in the United States 

13 during the period of 2002 through 2003, the inci14 dence of surgery for back pain-related conditions 

15 and joint replacement for chronic arthritis of the hip 

16 and knee varied 5.9-, 5.6-, and 4.8-fold, respectively, 

17 from the lowest to the highest region. 

18 (3) Discretionary surgery for the following com19 mon conditions accounts for 40 percent of Medicare 

20 spending for inpatient surgery: early stage cancer of 

21 the prostate; early stage cancer of the breast; osteo22 arthritis of the knee; osteoarthritis of the hip; osteo23 arthritis of the spine; chest pain due to coronary ar24 tery disease; stroke threat from carotid artery disVerDate Nov 24 2008 02:56 May 27, 2009 Jkt 079200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1133.IS S1133

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1 ease, ischemia due to peripheral artery disease; gall 

2 stones; and enlarged prostate. 

3 (4) Decisions that involve values trade-offs be4 tween the benefits and harms of 2 or more clinically 

5 appropriate alternatives should depend on the indi6 vidual patient’s informed choice. In everyday prac7 tice, however, patients typically delegate decision 

8 making to their physicians who may not have good 

9 information on the patient’s true preferences. 

10 (5) The current standard of medical care in the 

11 United States fails to adequately ensure that pa12 tients are informed about their treatment options 

13 and the risks and benefits of those options. This 

14 leads to patients getting medical treatments they 

15 may not have wanted had they been fully informed 

16 of their treatment options and integrated into the 

17 decision making process. 

18 (6) Patient decision aids are tools designed to 

19 help people participate in decision making about 

20 health care options. Patient decision aids provide in21 formation on treatment options and help patients 

22 clarify and communicate the personal value they as23 sociate with different features of treatment options. 

24 Patient decision aids do not advise people to choose 

25 one treatment option over another, nor are they 


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1 meant to replace practitioner consultation. Instead, 

2 they prepare patients to make informed, value-based 

3 decisions with their physician. 

4 (7) The Lewin Group estimated that the change 

5 in spending resulting from the use of patient deci6 sion aids for each of 11 conditions using per-proce7 dure costs estimated for the Medicare population 

8 studied, assuming full implementation of such pa9 tient decision aids in 2010, would save as much as 

10 $4,000,000,000. 

11 SEC. 3. DEFINITIONS. 

12 In this Act: 

13 (1) ELIGIBLE PROVIDER.— 

14 (A) IN GENERAL.—The term ‘‘eligible pro15 vider’’ means the following: 

16 (i) A primary care practice. 

17 (ii) A specialty practice. 

18 (iii) A multispecialty group practice. 

19 (iv) A hospital. 

20 (v) A rural health clinic. 

21 (vi) A Federally qualified health cen22 ter (as defined in section 1861(aa)(4) of 

23 the Social Security Act (42 U.S.C. 

24 1395x(aa)(4)). 

25 (vii) An integrated delivery system. 


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1 (viii) A State cooperative. 

2 (B) INCLUSION OF MEDICARE ADVANTAGE

3 PLANS.—Such term includes a Medicare Advan4 tage plan offered by a Medicare Advantage or5 ganization under part C of title XVIII of the 

6 Social Security Act (42 U.S.C. 1395w–21 et 

7 seq.). 

8 (2) PATIENT DECISION AID.—The term ‘‘pa9 tient decision aid’’ means an educational tool (such 

10 as the Internet, a video, or a pamphlet) that helps 

11 patients (or, if appropriate, the family caregiver of 

12 the patient) understand and communicate their be13 liefs and preferences related to their treatment op14 tions, and to decide with their health care provider 

15 what treatments are best for them based on their 

16 treatment options, scientific evidence, circumstances, 

17 beliefs, and preferences. 

18 (3) PREFERENCE SENSITIVE CARE.—The term 

19 ‘‘preference sensitive care’’ means medical care for 

20 which the clinical evidence does not clearly support 

21 one treatment option such that the appropriate 

22 course of treatment depends on the values of the pa23 tient or the preferences of the patient regarding the 

24 benefits, harms, and scientific evidence for each 

25 treatment option. The use of such care should deVerDate Nov 24 2008 02:56 May 27, 2009 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1133.IS S1133

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1 pend on informed patient choice among clinically ap2 propriate treatment options. Such term includes 

3 medical care for the conditions identified in section 

4 5(g). 

5 (4) SECRETARY.—The term ‘‘Secretary’’ means 

6 the Secretary of Health and Human Services. 

7 (5) SHARED DECISION MAKING.—The term 

8 ‘‘shared decision making’’ means a collaborative 

9 process between patient and clinician that engages 

10 the patient in decision making, provides patients 

11 with information about trade-offs among treatment 

12 options, and facilitates the incorporation of patient 

13 preferences and values into the medical plan. 

14 (6) STATE COOPERATIVE.—The term ‘‘State co15 operative’’ means an entity that includes the State 

16 government and at least one other health care pro17 vider which is set up for the purpose of testing 

18 shared decision making and patient decision aids. 

19 SEC. 4. ESTABLISHMENT OF INDEPENDENT STANDARDS 

20 FOR PATIENT DECISION AIDS. 

21 (a) CONTRACT WITH ENTITY TO ESTABLISH STAND22 ARDS AND CERTIFY PATIENT DECISION AIDS.— 

23 (1) CONTRACT.— 

24 (A) IN GENERAL.—For purposes of sup25 porting consensus-based standards for patient 


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1 decision aids and a certification process for pa2 tient decision aids for use in the Medicare pro3 gram and by other interested parties, the Sec4 retary shall identify and have in effect a con5 tract with an entity that meets the require6 ments described in paragraph (4). Such con7 tract shall provide that the entity perform the 

8 duties described in paragraph (2). 

9 (B) TIMING FOR FIRST CONTRACT.—As 

10 soon as practicable after the date of the enact11 ment of this Act, the Secretary shall enter into 

12 the first contract under subparagraph (A). 

13 (C) PERIOD OF CONTRACT.—A contract 

14 under subparagraph (A) shall be for a period of 

15 18 months (except such contract may be re16 newed after a subsequent bidding process). 

17 (D) COMPETITIVE PROCEDURES.—Com18 petitive procedures (as defined in section 4(5) 

19 of the Office of Federal Procurement Policy Act 

20 (41 U.S.C. 403(5))) shall be used to enter into 

21 a contract under subparagraph (A). 

22 (2) DUTIES.—The following duties are de23 scribed in this paragraph: 

24 (A) OPERATE AN OPEN AND TRANSPARENT

25 PROCESS.—The entity shall conduct its business 


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1 in an open and transparent manner and provide 

2 the opportunity for public comment on the ac3 tivities described in subparagraphs (B) and (C). 

4 (B) ESTABLISH STANDARDS FOR PATIENT

5 DECISION AIDS.— 

6 (i) IN GENERAL.—The entity shall 

7 synthesize evidence and convene a broad 

8 range of experts and key stakeholders to 

9 establish consensus-based standards, such 

10 as those developed by the International Pa11 tient Decision Aid Standard Collaboration, 

12 to determine which patient decision aids 

13 are high quality patient decision aids. 

14 (ii) DRAFT OF PROPOSED STAND15 ARDS.—The entity shall make a draft of 

16 proposed standards available to the public. 

17 (iii) 60-DAY COMMENT PERIOD.—Be18 ginning on the date the entity makes a 

19 draft of the proposed standards available 

20 under clause (ii), the entity shall provide a 

21 60-day period for public comment on such 

22 draft. 

23 (iv) FINAL STANDARDS.— 

24 (I) IN GENERAL.—The standards 

25 established by the entity under this 


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1 subparagraph shall be adopted by the 

2 board of the entity. 

3 (II) PUBLIC AVAILABILITY.—The 

4 entity shall make such standards 

5 available to the public. 

6 (C) CERTIFY PATIENT DECISION AIDS.— 

7 The entity shall review patient decision aids 

8 and certify whether patient decision aids meet 

9 the standards established under subparagraph 

10 (B) and offer a balanced presentation of treat11 ment options from both the clinical and patient 

12 experience perspectives. In conducting such re13 view and certification, the entity shall give pri14 ority to the review and certification of patient 

15 decision aids for conditions identified in section 

16 5(g). 

17 (3) REPORT TO THE EXPERT PANEL.—The en18 tity shall submit to the expert panel established 

19 under subsection (b) a report on the standards es20 tablished for patient decision aids under paragraph 

21 (2)(B) and patient decision aids that are certified as 

22 meeting such standards under paragraph (2)(C). 

23 (4) REQUIREMENTS DESCRIBED.—The fol24 lowing requirements are described in this paragraph: 


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1 (A) PRIVATE NONPROFIT.—The entity is a 

2 private nonprofit organization governed by a 

3 board. 

4 (B) EXPERIENCE.—The entity shall be 

5 able to demonstrate experience with— 

6 (i) consumer engagement; 

7 (ii) standard setting; 

8 (iii) health literacy; 

9 (iv) health care quality and safety 

10 issues; 

11 (v) certification processes; 

12 (vi) measure development; and 

13 (vii) evaluating health care quality. 

14 (C) MEMBERSHIP FEES.—If the entity re15 quires a membership fee for participation in the 

16 functions of the entity, such fees shall be rea17 sonable and adjusted based on the capacity of 

18 the potential member to pay the fee. In no case 

19 shall membership fees pose a barrier to the par20 ticipation of individuals or groups with low or 

21 nominal resources to participate in the func22 tions of the entity. 

23 (b) EXPERT PANEL.— 

24 (1) ESTABLISHMENT.—Not later than 120 days 

25 after the date of enactment of this Act, the SecVerDate Nov 24 2008 02:56 May 27, 2009 Jkt 079200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1133.IS S1133

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1 retary shall establish an expert panel to make rec2 ommendations to the Secretary regarding which pa3 tient decision aids should be implemented, appro4 priate training for health care providers on patient 

5 decision aids and shared decision making, and ap6 propriate quality measures for use in the pilot pro7 gram under section 5 and under section 1899 of the 

8 Social Security Act, as added by section 6. 

9 (2) DUTIES.—The expert panel shall carry out 

10 the following duties: 

11 (A) Approve patient decision aids, from 

12 among those patient decision aids certified 

13 under paragraph (2)(C) of subsection (a) by the 

14 entity with a contract under such subsection, 

15 for use in the pilot program under section 5 

16 (including to the extent practicable, patient de17 cision aids for the medical care of the condi18 tions described in section 5(g) and under sec19 tion 1899 of the Social Security Act, as added 

20 by section 6. 

21 (B) Review current training curricula for 

22 health care providers on patient decision aids 

23 and shared decision making and recommend a 

24 training process for eligible providers partici25 pating in the pilot program under section 5 on 


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1 the use of such approved patient decision aids 

2 and shared decision making. 

3 (C) Review existing quality measures re4 garding patient knowledge, value concordance, 

5 and health outcomes that have been endorsed 

6 through a consensus-based process and rec7 ommend appropriate quality measures for selec8 tion under section 5(h)(1). 

9 (3) APPOINTMENT.—The expert panel shall be 

10 composed of 13 members appointed by the Secretary 

11 from among leading experts in shared decision mak12 ing of whom— 

13 (A) 2 shall be researchers; 

14 (B) 2 shall be primary care physicians; 

15 (C) 2 shall be from surgical specialties; 

16 (D) 2 shall be patient or consumer commu17 nity advocates; 

18 (E) 2 shall be nonphysician health care 

19 providers (such as nurses, nurse practitioners, 

20 and physician assistants); 

21 (F) 1 shall be from an integrated multispe22 cialty group practice; 

23 (G) 1 shall be from the National Cancer 

24 Institute; and 


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1 (H) 1 shall be from the Centers for Dis2 ease Control and Prevention. 

3 (4) REPORT.—Not later than 2 years after such 

4 date of enactment and each year thereafter until the 

5 date of the termination of the expert panel under 

6 paragraph (5), the expert panel shall submit to the 

7 Secretary a report on the patient decision aids ap8 proved under paragraph (2)(A), the training process 

9 recommended under paragraph (2)(B), the quality 

10 measures recommended under paragraph (2)(C), 

11 and recommendations on other conditions or medical 

12 care the Secretary may want to include in the pilot 

13 program under section 5. 

14 (5) TERMINATION.—The expert panel shall ter15 minate on such date as the Secretary determines ap16 propriate. 

17 (c) QUALITY MEASURE DEVELOPMENT.— 

18 (1) IN GENERAL.—Section 1890(b)(1)(A) of the 

19 Social Security Act (42 U.S.C. 1395aaa(b)(1)(A)) is 

20 amended— 

21 (A) in clause (ii), by striking ‘‘and’’ at the 

22 end; and 

23 (B) by adding at the end the following new 

24 clause: 


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1 ‘‘(iv) that address conditions described 

2 in section 5(g) of the Empowering Medi3 care Patient Choices Act and regional 

4 practice variations under this title; and’’. 

5 (2) CONFORMING AMENDMENT.—Section 

6 1890(d) of the Social Security Act (42 U.S.C. 

7 1395aaa(d)) is amended— 

8 (A) by inserting ‘‘(other than subsection 

9 (b)(1)(A)(iv))’’ after ‘‘this section’’; and 

10 (B) by adding at the end the following new 

11 sentence: ‘‘For provisions relating to funding 

12 for the duties described in subsection 

13 (b)(1)(A)(iv), see section 5(l) of the Empow14 ering Medicare Patient Choices Act.’’. 

15 SEC. 5. ESTABLISHMENT OF SHARED DECISION MAKING 

16 PILOT PROGRAM UNDER THE MEDICARE 

17 PROGRAM. 

18 (a) IN GENERAL.—Not later than 12 months after 

19 the date of enactment of this Act, the Secretary shall es20 tablish a pilot program to provide for the phased-in devel21 opment, implementation, and evaluation of shared decision 

22 making under the Medicare program using patient deci23 sion aids to meet the objective of improving the under24 standing by Medicare beneficiaries of their medical treat25 ment options, as compared to comparable Medicare beneVerDate Nov 24 2008 02:56 May 27, 2009 Jkt 079200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S1133.IS S1133

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1 ficiaries who do not participate in a shared decision mak2 ing process using patient decision aids. 

3 (b) INITIAL IMPLEMENTATION (PHASE I).— 

4 (1) IN GENERAL.—During the initial implemen5 tation of the pilot program under this section (re6 ferred to in this section as ‘‘phase I’’ of the pilot 

7 program), the Secretary shall enroll in the pilot pro8 gram not more than 15 eligible providers who have 

9 experience in implementing, and have invested in the 

10 necessary infrastructure to implement, shared deci11 sion making using patient decision aids for a period 

12 of 3 years. 

13 (2) APPLICATION.—An eligible provider seeking 

14 to participate in the pilot program during phase I 

15 shall submit to the Secretary an application at such 

16 time and containing such information as the Sec17 retary may require. 

18 (3) PREFERENCE.—In enrolling eligible pro19 viders in the pilot program during phase I, the Sec20 retary shall give preference to eligible providers 

21 that— 

22 (A) have documented experience in using 

23 patient decision aids for the conditions identi24 fied in subsection (g) and in using shared deci25 sion making; 


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1 (B) have the necessary information tech2 nology infrastructure to collect the information 

3 required by the Secretary for reporting pur4 poses; 

5 (C) are trained in how to use patient deci6 sion aids and shared decision making; and 

7 (D) would be eligible to receive financial 

8 assistance as a Shared Decision Making Re9 source Center under subsection (c). 

10 (c) SHARED DECISION MAKING RESOURCE CEN11 TERS.— 

12 (1) IN GENERAL.—The Secretary shall provide 

13 financial assistance for the establishment and sup14 port of Shared Decision Making Resource Centers 

15 (referred to in this section as ‘‘centers’’) to provide 

16 technical assistance to eligible providers and to de17 velop and disseminate best practices and other infor18 mation to support and accelerate adoption, imple19 mentation, and effective use of patient decision aids 

20 and shared decision making by eligible providers 

21 under the Medicare program. 

22 (2) AFFILIATION.—Centers shall be affiliated 

23 with a United States-based organization or group 

24 that applies for and is awarded financial assistance 

25 under this subsection. The Secretary shall provide fiVerDate Nov 24 2008 02:56 May 27, 2009 Jkt 079200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\S1133.IS S1133

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1 nancial assistance to centers under this subsection 

2 on the basis of merit. 

3 (3) OBJECTIVES.—The objective of a center is 

4 to enhance and promote the adoption of patient deci5 sion aids and shared decision making through— 

6 (A) providing assistance to eligible pro7 viders with the implementation and effective use 

8 of, and training on, patient decision aids; 

9 (B) the dissemination of best practices and 

10 research on the implementation and effective 

11 use of patient decision aids; and 

12 (C) providing assistance to eligible pro13 viders applying to participate or participating in 

14 phase II of the pilot program under this section 

15 or under section 1899 of the Social Security 

16 Act, as added by section 6. 

17 (4) REGIONAL ASSISTANCE.—Each center shall 

18 aim to provide assistance and education to all eligi19 ble providers in a region, including direct assistance 

20 to the following eligible providers: 

21 (A) Public or not-for-profit hospitals or 

22 critical access hospitals (as defined in section 

23 1861(mm)(1) of the Social Security Act (42 

24 U.S.C. 1395x(mm)(1)). 


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1 (B) Federally qualified health centers (as 

2 defined in section 1861(aa)(4) of the Social Se3 curity Act (42 U.S.C. 1395x(aa)(4)). 

4 (C) Entities that are located in a rural 

5 area or in area that serves uninsured, under6 insured, and medically underserved individuals 

7 (regardless of whether such area is urban or 

8 rural). 

9 (D) Individual or small group practices (or 

10 a consortium thereof) that are primarily fo11 cused on primary care. 

12 (5) FINANCIAL ASSISTANCE.— 

13 (A) IN GENERAL.—The Secretary may 

14 provide financial assistance for a period of 8 

15 years to any regional center established or sup16 ported under this subsection. 

17 (B) COST-SHARING REQUIREMENT.— 

18 (i) IN GENERAL.—Except as provided 

19 in clause (ii), the Secretary shall not pro20 vide as financial assistance under this sub21 section more than 50 percent of the capital 

22 and annual operating and maintenance 

23 funds required to establish and support 

24 such a center. 


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1 (ii) WAIVER OF COST-SHARING RE2 QUIREMENT.—The Secretary may waive 

3 the limitation under clause (i) if the Sec4 retary determines that, as a result of na5 tional economic conditions, such limitation 

6 would be detrimental to the pilot program 

7 under this section. If the Secretary waives 

8 such limitation under the preceding sen9 tence, the Secretary shall submit to Con10 gress a report containing the Secretary’s 

11 justification for such waiver. 

12 (6) NOTICE OF PROGRAM DESCRIPTION AND

13 AVAILABILITY OF FUNDS.—The Secretary shall pub14 lish in the Federal Register, not later than 12 

15 months after the date of the enactment of this Act, 

16 a draft description of a program for establishing and 

17 supporting regional centers under this subsection. 

18 Such draft description shall include the following: 

19 (A) A detailed explanation of the program 

20 and the program goals. 

21 (B) Procedures to be followed by appli22 cants for financial assistance. 

23 (C) Criteria for determining which appli24 cants are qualified to receive financial assist25 ance. 


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1 (D) Maximum support levels expected to 

2 be available to centers under the program. 

3 (7) APPLICATION REVIEW.—The Secretary shall 

4 review each application for financial assistance 

5 under this subsection based on merit. In making a 

6 decision whether to approve such application and 

7 provide financial assistance, the Secretary shall con8 sider at a minimum the merits of the application, in9 cluding those portions of the application regarding— 

10 (A) the ability of the applicant to provide 

11 assistance to particular categories of eligible 

12 providers with respect to the implementation 

13 and effective use of, and training on, patient 

14 decision aids; 

15 (B) the geographical diversity and extent 

16 of the service area of the applicant; and 

17 (C) the percentage of funding for the cen18 ter that would be provided as financial assist19 ance under this subsection and the amount of 

20 any funding or in-kind commitment from 

21 sources of funding in addition to the financial 

22 assistance provided under this subsection. 

23 (8) BIENNIAL EVALUATION.—Each center 

24 which receives financial assistance under this sub25 section shall be evaluated biennially by an evaluation 


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1 panel appointed by the Secretary. Each such evalua2 tion panel shall be composed of private experts, none 

3 of whom shall be connected with the center involved, 

4 and officials of the Federal Government. Each eval5 uation panel shall measure the performance of the 

6 center involved against the objectives specified in 

7 paragraph (3). The Secretary shall not continue to 

8 provide financial assistance to a center under this 

9 subsection unless the most recent evaluation under 

10 this paragraph with respect to the center is overall 

11 positive. 

12 (d) EXPANDED IMPLEMENTATION (PHASE II).— 

13 (1) IN GENERAL.—Subject to paragraph (2), 

14 during the 3-year period beginning after the comple15 tion of phase I of the pilot program (referred to in 

16 this section as ‘‘phase II’’ of the pilot program), the 

17 Secretary shall enroll additional eligible providers to 

18 implement shared decision making using patient de19 cision aids under the pilot program under this sec20 tion. The Secretary may allow eligible providers to 

21 enroll in the pilot program on a regular basis during 

22 phase II. 

23 (2) CONTINGENCY.—The Secretary shall not 

24 implement phase II of the pilot program if the Sec25 retary finds, not later than 90 days after the date 


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1 of submittal of the interim report under subsection 

2 (i)(2)(A), that the continued implementation of 

3 shared decision making is not in the best interest of 

4 Medicare beneficiaries. 

5 (3) PREFERENCE.—In enrolling eligible pro6 viders in the pilot program during phase II, the Sec7 retary shall include, to the extent practicable, eligible 

8 providers that— 

9 (A) have or can acquire the infrastructure 

10 necessary to implement shared decision making 

11 supported by patient decision aids approved by 

12 the expert panel established under section 4(b) 

13 in a timely manner; 

14 (B) have training in the use of patient de15 cision aids or will participate in training for 

16 health care professionals who will be involved in 

17 such use (as specified by the Secretary); or 

18 (C) represent high cost areas or high prac19 tice variation States under the Medicare pro20 gram, and the District of Columbia. 

21 (e) GUIDANCE.—The Secretary may, in consultation 

22 with the expert panel established under section 4(b), issue 

23 guidance to eligible providers participating in the pilot 

24 program under this section on the use of patient decision 

25 aids approved by the expert panel. 


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1 (f) REQUIREMENTS.— 

2 (1) IMPLEMENTATION OF APPROVED PATIENT

3 DECISION AIDS.— 

4 (A) IN GENERAL.—During phase II of the 

5 pilot program under this section, an eligible 

6 provider participating in the pilot program shall 

7 incorporate 1 or more patient decision aids ap8 proved by the expert panel established under 

9 section 4(b) in furnishing items and services to 

10 Medicare beneficiaries with respect to 1 or more 

11 of the conditions identified in subsection (g), to12 gether with ongoing support involved in fur13 nishing such items and services. 

14 (B) DEFINED CLINICAL PROCESS.—During 

15 each phase of the pilot program under this sec16 tion, the eligible provider shall establish and im17 plement a defined clinical process under which, 

18 in the case of a Medicare beneficiary with 1 or 

19 more of such conditions, the eligible provider of20 fers the Medicare beneficiary shared decision 

21 making (supported by such a patient decision 

22 aid) and collects information on the quality of 

23 patient decision making with respect to the 

24 Medicare beneficiary. 

25 (2) FOLLOW-UP COUNSELING VISIT.— 


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1 (A) IN GENERAL.—During each phase of 

2 the pilot program under this section, an eligible 

3 provider participating in the pilot program 

4 under this section shall routinely schedule Medi5 care beneficiaries for a counseling visit after the 

6 viewing of such a patient decision aid to answer 

7 any questions the beneficiary may have with re8 spect to the medical care of the condition in9 volved and to assist the beneficiary in thinking 

10 through how their preferences and concerns re11 late to their medical care. 

12 (B) PAYMENT FOR FOLLOW-UP COUN13 SELING VISIT.—The Secretary shall establish 

14 procedures for making payments for such coun15 seling visits provided to Medicare beneficiaries 

16 during each phase of the pilot program under 

17 this section. Such procedures shall provide for 

18 the establishment— 

19 (i) of a code (or codes) to represent 

20 such services; and 

21 (ii) of a single payment amount for 

22 such service that includes the professional 

23 time of the health care provider and a por24 tion of the reasonable costs of the infra25 structure of the eligible provider. 


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1 (C) LIMITATION.—In the case of an eligi2 ble provider that is a Medicare Advantage plan, 

3 such eligible provider may not receive payment 

4 for such services. 

5 (3) WAIVER OF COINSURANCE.—The Secretary 

6 shall establish procedures under which an eligible 

7 provider participating in the pilot program under 

8 this section may, in the case of a low-income Medi9 care beneficiary (as determined by the Secretary), 

10 waive any coinsurance or copayment that would oth11 erwise apply for the follow-up counseling visit pro12 vided to such Medicare beneficiary under paragraph 

13 (2). 

14 (4) COSTS OF IMPLEMENTATION.— 

15 (A) IN GENERAL.—Subject to subpara16 graph (B), during each phase of the pilot pro17 gram, an eligible provider participating in the 

18 pilot program shall be responsible for the costs 

19 of selecting, purchasing, and incorporating such 

20 patient decision aids into the group practice, re21 porting data on quality measures selected under 

22 subsection (h)(1), and recording outcomes 

23 under the pilot program. 

24 (B) FINANCIAL SUPPORT.—During each 

25 such phase, the Secretary may, in addition to 


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1 payments for counseling visits under paragraph 

2 (2), provide financial support to an eligible pro3 vider participating in the pilot program to ac4 quire the infrastructure necessary to participate 

5 in the pilot program, including the development 

6 of clinical pathways to assure that Medicare 

7 beneficiaries have access to high-quality shared 

8 decision making, the reporting of data on qual9 ity measures selected under subsection (h)(1), 

10 and the recording of outcomes under the pilot 

11 program after phase I of the pilot program (as 

12 determined appropriate by the Secretary). 

13 (g) PREFERENCE SENSITIVE CARE DESCRIBED.— 

14 The patient decision aids approved under section 

15 4(b)(2)(A) shall, to the extent practicable, include patient 

16 decision aids for medical care of the following conditions: 

17 (1) Arthritis of the hip and knee. 

18 (2) Chronic back pain. 

19 (3) Chest pain (stable angina). 

20 (4) Enlarged prostate (benign prostatic hyper21 trophy, or BPH). 

22 (5) Early-stage prostate cancer. 

23 (6) Early-stage breast cancer. 

24 (7) End-of-life care. 

25 (8) Peripheral vascular disease. 


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1 (9) Gall stones. 

2 (10) Threat of stroke from carotid artery dis3 ease. 

4 (11) Any other condition the Secretary identi5 fies as appropriate. 

6 (h) QUALITY MEASURES.— 

7 (1) SELECTION.— 

8 (A) IN GENERAL.—During each phase of 

9 the pilot program, the Secretary shall measure 

10 the quality and implementation of shared deci11 sion making. For purposes of making such 

12 measurements, the Secretary shall select, from 

13 among those quality measures recommended by 

14 the expert panel under section 4(b)(2)(C), con15 sensus-based quality measures that assess 

16 Medicare beneficiaries’ knowledge of the options 

17 for medical treatment relevant to their medical 

18 condition, as well as the benefits and drawbacks 

19 of those medical treatment options, and the 

20 Medicare beneficiaries’ goals and concerns re21 garding their medical care. 

22 (B) RISK ADJUSTMENT.—In order to en23 sure accurate measurement across quality 

24 measures and eligible providers, the Secretary 

25 may risk adjust the quality measures selected 


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1 under this paragraph to control for external 

2 factors, such as cognitive impairment, demen3 tia, and literacy. 

4 (2) REPORTING DATA ON MEASURES.—During 

5 each such phase, an eligible provider participating in 

6 the pilot program shall report to the Secretary data 

7 on quality measures selected under paragraph (1) in 

8 accordance with procedures established by the Sec9 retary. 

10 (3) FEEDBACK ON MEASURES.—During each 

11 such phase, the Secretary shall provide confidential 

12 reports to eligible providers participating in the pilot 

13 program on the performance of the eligible provider 

14 on quality measures selected by the Secretary under 

15 paragraph (1), the aggregate performance of all eli16 gible providers participating in the pilot program, 

17 and any improvements in such performance. 

18 (i) EVALUATIONS AND REPORTS.— 

19 (1) INDEPENDENT EVALUATION.—The Sec20 retary shall enter into a contract with an entity that 

21 has knowledge of shared decision making programs 

22 and demonstrated experience in the evaluation of 

23 such programs for the conduct of an independent 

24 evaluation of each phase of the pilot program under 

25 this section. 


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1 (2) REPORTS BY ENTITY CONDUCTING INDE2 PENDENT EVALUATION.— 

3 (A) INTERIM REPORT.—Not later than 2 

4 years after the implementation of phase I of the 

5 pilot program, the entity with a contract under 

6 paragraph (1) shall submit to the Secretary a 

7 report on the initial results of the independent 

8 evaluation conducted under such paragraph. 

9 (B) FINAL REPORT.—Not later then 4 

10 years after the implementation of phase II of 

11 the pilot program, such entity shall submit to 

12 the Secretary a report on the final results of 

13 such independent evaluation. 

14 (C) CONTENTS OF REPORT.—Each report 

15 submitted under this paragraph shall— 

16 (i) include an assessment of— 

17 (I) quality measures selected 

18 under subsection (h)(1); 

19 (II) Medicare beneficiary and 

20 health care provider satisfaction under 

21 the applicable phase of the pilot pro22 gram; 

23 (III) utilization of medical serv24 ices for Medicare beneficiaries with 1 

25 or more of the conditions described in 


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1 subsection (g) and other Medicare 

2 beneficiaries as determined appro3 priate by the Secretary; 

4 (IV) appropriate utilization of 

5 shared decision making by eligible 

6 providers under the applicable phase 

7 of the pilot program; 

8 (V) savings to the Medicare pro9 gram under title XVIII of the Social 

10 Security Act; and 

11 (VI) the costs to eligible pro12 viders participating in the pilot pro13 gram of selecting, purchasing, and in14 corporating approved patient decision 

15 aids and meeting reporting require16 ments under the applicable phase of 

17 the pilot program; and 

18 (ii) identify the characteristics of indi19 vidual eligible providers that are most ef20 fective in implementing shared decision 

21 making under the applicable phase of the 

22 pilot program. 

23 (3) REPORT BY THE SECRETARY.—Not later 

24 than 12 months after the completion of phase II of 

25 the pilot program, the Secretary shall submit to 


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1 Congress a report on the pilot program that in2 cludes— 

3 (A) the results of the independent evalua4 tion conducted under paragraph (2); 

5 (B) an evaluation of the impact of the pilot 

6 program under this section, including the im7 pact— 

8 (i) of the use of patient decision aids 

9 approved by the expert panel established 

10 under section 4(b) for the medical care of 

11 the conditions described in subsection (g); 

12 (ii) on expenditures for such condi13 tions under the Medicare program, includ14 ing a comparison of such expenditures for 

15 such conditions where such patient deci16 sion aids were used to such expenditures 

17 for such conditions where such patient de18 cision aids were not used; and 

19 (iii) on Medicare beneficiaries, includ20 ing the understanding by beneficiaries of 

21 the options for medical care presented, 

22 concordance between beneficiary values 

23 and the medical care received, the mode of 

24 approved patient decision aid used (such as 

25 Internet, videos, and pamphlets), the timVerDate Nov 24 2008 02:56 May 27, 2009 Jkt 079200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\S1133.IS S1133

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1 ing of the delivery of such approved patient 

2 decision aid (such as the date of the initial 

3 diagnosis), and beneficiary and health care 

4 provider satisfaction with the shared deci5 sion making process; 

6 (C) an evaluation of which eligible pro7 viders are most effective at implementing pa8 tient decision aids and assisting Medicare bene9 ficiaries in making informed decisions on med10 ical care; and 

11 (D) recommendations for such legislation 

12 and administrative action as the Secretary de13 termines appropriate. 

14 (j) SAVINGS.— 

15 (1) IN GENERAL.—Subject to paragraph (2), 

16 not later than 2 years after the implementation of 

17 phase I of the pilot program, and annually there18 after for the duration of phase I and the first 2 

19 years of phase II, the Secretary shall determine if 

20 there were any savings to the Medicare program as 

21 a result of such implementation during the preceding 

22 year (or years, if applicable). In the case where the 

23 Secretary determines there were such savings, the 

24 Secretary shall use such savings as follows: 


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1 (A) Fifty percent of such savings shall be 

2 used to provide bonus payments to eligible pro3 viders participating in the pilot program who 

4 achieve high quality shared decision making (as 

5 measured by the level of participation of Medi6 care beneficiaries in the shared decision making 

7 process and high scores by the eligible provider 

8 on quality measures selected under subsection 

9 (h)(1)). 

10 (B) Twenty-five percent of such savings 

11 shall be placed in a Shared Decision Making 

12 Trust Fund established by the Secretary, which 

13 shall be used to expand participation in the 

14 pilot program to providers of services and sup15 pliers in additional settings (as determined ap16 propriate by the Secretary) by— 

17 (i) providing financial assistance 

18 under subsection (c); and 

19 (ii) providing for the development of 

20 quality measures not already selected 

21 under subsection (h)(1) to assess the im22 pact of shared decision making on the 

23 quality of patient care or the improvement 

24 of such quality measures already selected. 


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1 (C) Twenty-five percent of such savings 

2 shall be retained by the Medicare program. 

3 (2) RETENTION OF SAVINGS BY THE MEDICARE

4 PROGRAM.—In the case where the Secretary deter5 mines there are savings to the Medicare program as 

6 a result of the implementation of the pilot program 

7 during a year (beginning with the third year of 

8 phase II), 100 percent of such savings shall be re9 tained by the Medicare program. 

10 (k) WAIVER.—The Secretary may waive such provi11 sions of titles XI and XVIII of the Social Security Act 

12 as may be necessary to carry out the pilot program under 

13 this section. 

14 (l) FUNDING.—For purposes of carrying out section 

15 4(a), implementing the pilot program under this section 

16 (including costs incurred in conducting the evaluation 

17 under subsection (i)), and carrying out section 

18 1890(b)(1)(A)(iv) of the Social Security Act, as added by 

19 section 4(c), the Secretary shall provide for the transfer 

20 from the Federal Hospital Insurance Trust Fund estab21 lished under section 1817 of the Social Security Act (42 

22 U.S.C. 1395i) to the Centers for Medicare & Medicaid 

23 Services Program Management Account of $300,000,000 

24 for the period of fiscal years 2010 through 2017. 


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1 SEC. 6. ESTABLISHMENT OF SHARED DECISION MAKING 

2 STANDARDS AND REQUIREMENTS IN MEDI3 CARE. 

4 Title XVIII of the Social Security Act (42 U.S.C. 

5 1395 et seq.) is amended by adding at the end the fol6 lowing new section: 

7 ‘‘ESTABLISHMENT OF SHARED DECISION MAKING

8 STANDARDS AND REQUIREMENTS

9 ‘‘SEC. 1899. (a) IN GENERAL.—Based on the find10 ings of phases I and II of the pilot program under section 

11 5 of the Empowering Medicare Patient Choices Act the 

12 Secretary shall promulgate regulations that— 

13 ‘‘(1) specify for which preference sensitive con14 ditions beneficiaries should, subject to the suc15 ceeding provisions of this section, participate in 

16 shared decision making; 

17 ‘‘(2) require providers of services and suppliers 

18 to make sure that beneficiaries receive patient deci19 sion aids as appropriate; and 

20 ‘‘(3) specify a process for beneficiaries to elect 

21 not to use such patient decision aids. 

22 ‘‘(b) PENALTY FOR NOT USING SHARED DECISION

23 MAKING.—Notwithstanding any other provision of this 

24 title, the Secretary shall promulgate such regulations and 

25 issue such guidance as may be necessary to reduce by 20 

26 percent the amount of payment under this title that would 


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1 otherwise apply to an item or service specified by the Sec2 retary if the patient does not receive a patient decision 

3 aid prior to such item or service being furnished (except 

4 in the case where the beneficiary has elected not to use 

5 such patient decision aid under the process specified under 

6 subsection (a)(3)). 

7 ‘‘(c) SECRETARIAL AUTHORITY TO WAIVE APPLICA8 TION OF THIS SECTION.—The Secretary may waive the 

9 application of this section to an item or service under this 

10 title if the Secretary determines either of the following: 

11 ‘‘(1) Medical societies and others have estab12 lished evidence-based transparent standards incor13 porating patient decision aids and shared decision 

14 making into the standard of patient care for pref15 erence sensitive conditions. 

16 ‘‘(2) Shared decision making is not in the best 

17 interest of beneficiaries.’’. 

Æ 


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