[Congressional Record Volume 155, Number 79 (Thursday, May 21, 2009)]
[Senate]
[Pages S5836-S5840]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. WYDEN (for himself and Mr. Gregg):
  S. 1133. 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; to the Committee on 
Finance.
  Mr. WYDEN. Mr. President, I am pleased to be joined by my colleague, 
the distinguished Senator from New Hampshire, Judd Gregg, to introduce 
an important bill that will put patients in the driver's seat of their 
medical care. Today, my fellow Oregonian Representative Earl Blumenauer 
is introducing the same bill in the House of Representatives.
  On the Senate floor and in the Finance Committee and Health Education 
Labor and Pensions Committee, senators have been wrestling with health 
reform. The challenge before the Congress is to both expand quality, 
affordable coverage to all Americans while containing costs.
  Cost containment requires a lot of tough choices because it will 
require changing how care is delivered. The time of paying for volume 
and low quality is past. Chairman Baucus rightly recognized the 
challenges in cost containment and took up this issue as the first area 
he wanted to address in the series of public roundtables held in the 
Finance Committee.
  I believe the key to transforming the health care system and cost 
containment is to give patients more choices. Patients should have more 
choices of health insurance plans. Patients should have a choice of 
doctor. Patients should also have choices in their medical care.
  The research by Dr. Jim Weinstein and Dr. John Wennberg with the 
Dartmouth Atlas Project has documented regional variations in medical 
care. They have found both underuse, or the failure to deliver needed 
evidence-based care, and overuse, or the delivery of unnecessary 
supply-sensitive care. Regional variations are driven by local medical 
opinion, rather than sound science or the preferences of well-informed 
patients. Just because doctors are licensed to have a hammer, doesn't 
make every patient a nail.
  Using their research, Office of Management and Budget Director Peter 
Orszag and other experts have estimated that as much as 30 percent of 
medical spending today goes to care that is unnecessary. That is 30 
percent of $2.5 trillion is $750 billion going to care that does not 
make patients healthier and may even harm them.
  The current standard of medical care in the U.S. fails to adequately 
ensure that patients are informed about all their treatment options and 
the risks and benefits of those options. This leads to patients getting 
medical treatments they may not have wanted had they been fully 
informed of their treatment options and integrated into the decision 
making process. In order to deliver the right care at the right time, 
informed patient choice should be the goal of medical care.
  Shared decision making is a collaborative process between the doctor 
and patient when they discuss the trade-offs among treatment options 
and discuss the patient's preferences and values. Shared decision 
making uses patient decision aids, an educational tool like a video or 
pamphlet that helps patients understand, communicate their beliefs and 
preferences related to their treatment options, and decide what medical 
treatments are best for them with their provider based on their medical 
treatment options, scientific evidence, circumstances, beliefs and 
preferences.
  Informed patients choice depends on clinical comparative 
effectiveness research that compares the effectiveness of health care 
treatments. Shared decision making and patient decision aids use 
clinical comparative effectiveness research so that doctors and 
patients together make the right medical treatment choice for each 
individual patient.
  This bill creates a three stage phase in of patient decision aids and 
shared decision making into the Medicare program. Phase I of the pilot 
is a 3-year period allowing `early adopting' providers--those who 
already have experience using patient decision aids and incorporating 
them into their clinical practices--to participate in the pilot 
providing data for the Secretary and also serve as Shared Decision 
Making Resource Centers. During this period, an independent entity will 
develop consensus based standards for patient decision aids and a 
certification process to ensure decision aids are effective and provide 
unbiased information. An expert panel then recommends to the Secretary 
which patient decision aids may be used in this program.
  Phase II is a 3-year period during which providers will be eligible 
to receive reimbursement for the use of certified patient decision 
aids. New providers may be added on an annual basis allowing for the 
gradual and voluntary expansion of shared decision making and patient 
decision aids to a large portion of the country.
  The final stage requires all Medicare providers to ensure that 
Medicare beneficiaries receive shared decision making and patient 
decision aids prior to receiving treatment for a preference sensitive 
condition. If a provider does not ensure that a patient receives a 
patient decision aid then the provider's reimbursement may be reduced 
by no more than 20 percent.
  This legislation is built on a shared savings model distributing 50 
percent of the savings to participating providers based on their 
participation and performance on quality measures. Twenty-five percent 
of the savings are used to expand provider participation providing 
financial support to the Shared Decision Making Centers and providers. 
The final 25 percent savings are returned to the Medicare program. As 
shared decision making becomes the standard of practice, the shared 
savings percentages phases out.
  I believe that this simple approach to informed patient choice is 
critically important to giving patients real choices by engaging them 
in their health care. As we look to expand access to health coverage, 
this bill provides a bipartisan, sensible path to putting patients in 
the driver's seat.
  I hope my colleagues will join me in supporting this bill, and I look 
forward to working with Chairman Baucus and Ranking Member Grassley and 
other members of the Finance Committee to secure passage of this 
important bill.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1133

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Empowering Medicare Patient 
     Choices Act''.

     SEC. 2. FINDINGS.

       Congress makes the following findings:
       (1) The Dartmouth Atlas Project's work documenting regional 
     variations in medical care has found both underuse, or the 
     failure to deliver needed evidence-based care, and overuse, 
     or the delivery of unnecessary supply-sensitive care.
       (2) The Dartmouth Atlas Project has also found that many 
     clinical decisions physicians make for elective medical 
     treatments are driven by local medical opinion, rather than 
     sound science or the preferences of well-informed patients. 
     For example, the Dartmouth Atlas Project found that, among 
     the 306 Hospital Referral Regions in the United States during 
     the period of 2002 through 2003, the incidence of surgery for 
     back pain-related conditions and joint replacement for 
     chronic arthritis of the hip and knee varied 5.9-, 5.6-, and 
     4.8-fold, respectively, from the lowest to the highest 
     region.
       (3) Discretionary surgery for the following common 
     conditions accounts for 40 percent of Medicare spending for 
     inpatient surgery: early stage cancer of the prostate; early 
     stage cancer of the breast; osteoarthritis of the knee; 
     osteoarthritis of the hip; osteoarthritis of the spine; chest 
     pain due to coronary artery disease; stroke threat from 
     carotid artery disease, ischemia due to peripheral artery 
     disease; gall stones; and enlarged prostate.
       (4) Decisions that involve values trade-offs between the 
     benefits and harms of 2 or more clinically appropriate 
     alternatives should depend on the individual patient's 
     informed choice. In everyday practice, however, patients 
     typically delegate decision making to their physicians who 
     may not have good information on the patient's true 
     preferences.
       (5) The current standard of medical care in the United 
     States fails to adequately ensure that patients are informed 
     about their treatment options and the risks and benefits of 
     those options. This leads to patients getting medical 
     treatments they may not have wanted had they been fully 
     informed of their treatment options and integrated into the 
     decision making process.
       (6) Patient decision aids are tools designed to help people 
     participate in decision making

[[Page S5837]]

     about health care options. Patient decision aids provide 
     information on treatment options and help patients clarify 
     and communicate the personal value they associate with 
     different features of treatment options. Patient decision 
     aids do not advise people to choose one treatment option over 
     another, nor are they meant to replace practitioner 
     consultation. Instead, they prepare patients to make 
     informed, value-based decisions with their physician.
       (7) The Lewin Group estimated that the change in spending 
     resulting from the use of patient decision aids for each of 
     11 conditions using per-procedure costs estimated for the 
     Medicare population studied, assuming full implementation of 
     such patient decision aids in 2010, would save as much as 
     $4,000,000,000.

     SEC. 3. DEFINITIONS.

       In this Act:
       (1) Eligible provider.--
       (A) In general.--The term ``eligible provider'' means the 
     following:
       (i) A primary care practice.
       (ii) A specialty practice.
       (iii) A multispecialty group practice.
       (iv) A hospital.
       (v) A rural health clinic.
       (vi) A Federally qualified health center (as defined in 
     section 1861(aa)(4) of the Social Security Act (42 U.S.C. 
     1395x(aa)(4)).
       (vii) An integrated delivery system.
       (viii) A State cooperative.
       (B) Inclusion of medicare advantage plans.--Such term 
     includes a Medicare Advantage plan offered by a Medicare 
     Advantage organization under part C of title XVIII of the 
     Social Security Act (42 U.S.C. 1395w-21 et seq.).
       (2) Patient decision aid.--The term ``patient decision 
     aid'' means an educational tool (such as the Internet, a 
     video, or a pamphlet) that helps patients (or, if 
     appropriate, the family caregiver of the patient) understand 
     and communicate their beliefs and preferences related to 
     their treatment options, and to decide with their health care 
     provider what treatments are best for them based on their 
     treatment options, scientific evidence, circumstances, 
     beliefs, and preferences.
       (3) Preference sensitive care.--The term ``preference 
     sensitive care'' means medical care for which the clinical 
     evidence does not clearly support one treatment option such 
     that the appropriate course of treatment depends on the 
     values of the patient or the preferences of the patient 
     regarding the benefits, harms, and scientific evidence for 
     each treatment option. The use of such care should depend on 
     informed patient choice among clinically appropriate 
     treatment options. Such term includes medical care for the 
     conditions identified in section 5(g).
       (4) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.
       (5) Shared decision making.--The term ``shared decision 
     making'' means a collaborative process between patient and 
     clinician that engages the patient in decision making, 
     provides patients with information about trade-offs among 
     treatment options, and facilitates the incorporation of 
     patient preferences and values into the medical plan.
       (6) State cooperative.--The term ``State cooperative'' 
     means an entity that includes the State government and at 
     least one other health care provider which is set up for the 
     purpose of testing shared decision making and patient 
     decision aids.

     SEC. 4. ESTABLISHMENT OF INDEPENDENT STANDARDS FOR PATIENT 
                   DECISION AIDS.

       (a) Contract With Entity to Establish Standards and Certify 
     Patient Decision Aids.--
       (1) Contract.--
       (A) In general.--For purposes of supporting consensus-based 
     standards for patient decision aids and a certification 
     process for patient decision aids for use in the Medicare 
     program and by other interested parties, the Secretary shall 
     identify and have in effect a contract with an entity that 
     meets the requirements described in paragraph (4). Such 
     contract shall provide that the entity perform the duties 
     described in paragraph (2).
       (B) Timing for first contract.--As soon as practicable 
     after the date of the enactment of this Act, the Secretary 
     shall enter into the first contract under subparagraph (A).
       (C) Period of contract.--A contract under subparagraph (A) 
     shall be for a period of 18 months (except such contract may 
     be renewed after a subsequent bidding process).
       (D) Competitive procedures.--Competitive procedures (as 
     defined in section 4(5) of the Office of Federal Procurement 
     Policy Act (41 U.S.C. 403(5))) shall be used to enter into a 
     contract under subparagraph (A).
       (2) Duties.--The following duties are described in this 
     paragraph:
       (A) Operate an open and transparent process.--The entity 
     shall conduct its business in an open and transparent manner 
     and provide the opportunity for public comment on the 
     activities described in subparagraphs (B) and (C).
       (B) Establish standards for patient decision aids.--
       (i) In general.--The entity shall synthesize evidence and 
     convene a broad range of experts and key stakeholders to 
     establish consensus-based standards, such as those developed 
     by the International Patient Decision Aid Standard 
     Collaboration, to determine which patient decision aids are 
     high quality patient decision aids.
       (ii) Draft of proposed standards.--The entity shall make a 
     draft of proposed standards available to the public.
       (iii) 60-day comment period.--Beginning on the date the 
     entity makes a draft of the proposed standards available 
     under clause (ii), the entity shall provide a 60-day period 
     for public comment on such draft.
       (iv) Final standards.--

       (I) In general.--The standards established by the entity 
     under this subparagraph shall be adopted by the board of the 
     entity.
       (II) Public availability.--The entity shall make such 
     standards available to the public.

       (C) Certify patient decision aids.--The entity shall review 
     patient decision aids and certify whether patient decision 
     aids meet the standards established under subparagraph (B) 
     and offer a balanced presentation of treatment options from 
     both the clinical and patient experience perspectives. In 
     conducting such review and certification, the entity shall 
     give priority to the review and certification of patient 
     decision aids for conditions identified in section 5(g).
       (3) Report to the expert panel.--The entity shall submit to 
     the expert panel established under subsection (b) a report on 
     the standards established for patient decision aids under 
     paragraph (2)(B) and patient decision aids that are certified 
     as meeting such standards under paragraph (2)(C).
       (4) Requirements described.--The following requirements are 
     described in this paragraph:
       (A) Private nonprofit.--The entity is a private nonprofit 
     organization governed by a board.
       (B) Experience.--The entity shall be able to demonstrate 
     experience with--
       (i) consumer engagement;
       (ii) standard setting;
       (iii) health literacy;
       (iv) health care quality and safety issues;
       (v) certification processes;
       (vi) measure development; and
       (vii) evaluating health care quality.
       (C) Membership fees.--If the entity requires a membership 
     fee for participation in the functions of the entity, such 
     fees shall be reasonable and adjusted based on the capacity 
     of the potential member to pay the fee. In no case shall 
     membership fees pose a barrier to the participation of 
     individuals or groups with low or nominal resources to 
     participate in the functions of the entity.
       (b) Expert Panel.--
       (1) Establishment.--Not later than 120 days after the date 
     of enactment of this Act, the Secretary shall establish an 
     expert panel to make recommendations to the Secretary 
     regarding which patient decision aids should be implemented, 
     appropriate training for health care providers on patient 
     decision aids and shared decision making, and appropriate 
     quality measures for use in the pilot program under section 5 
     and under section 1899 of the Social Security Act, as added 
     by section 6.
       (2) Duties.--The expert panel shall carry out the following 
     duties:
       (A) Approve patient decision aids, from among those patient 
     decision aids certified under paragraph (2)(C) of subsection 
     (a) by the entity with a contract under such subsection, for 
     use in the pilot program under section 5 (including to the 
     extent practicable, patient decision aids for the medical 
     care of the conditions described in section 5(g) and under 
     section 1899 of the Social Security Act, as added by section 
     6.
       (B) Review current training curricula for health care 
     providers on patient decision aids and shared decision making 
     and recommend a training process for eligible providers 
     participating in the pilot program under section 5 on the use 
     of such approved patient decision aids and shared decision 
     making.
       (C) Review existing quality measures regarding patient 
     knowledge, value concordance, and health outcomes that have 
     been endorsed through a consensus-based process and recommend 
     appropriate quality measures for selection under section 
     5(h)(1).
       (3) Appointment.--The expert panel shall be composed of 13 
     members appointed by the Secretary from among leading experts 
     in shared decision making of whom--
       (A) 2 shall be researchers;
       (B) 2 shall be primary care physicians;
       (C) 2 shall be from surgical specialties;
       (D) 2 shall be patient or consumer community advocates;
       (E) 2 shall be nonphysician health care providers (such as 
     nurses, nurse practitioners, and physician assistants);
       (F) 1 shall be from an integrated multispecialty group 
     practice;
       (G) 1 shall be from the National Cancer Institute; and
       (H) 1 shall be from the Centers for Disease Control and 
     Prevention.
       (4) Report.--Not later than 2 years after such date of 
     enactment and each year thereafter until the date of the 
     termination of the expert panel under paragraph (5), the 
     expert panel shall submit to the Secretary a report on the 
     patient decision aids approved under paragraph (2)(A), the 
     training process recommended under paragraph (2)(B), the 
     quality measures recommended under paragraph (2)(C), and 
     recommendations on other conditions or medical care the 
     Secretary may want to include in the pilot program under 
     section 5.
       (5) Termination.--The expert panel shall terminate on such 
     date as the Secretary determines appropriate.
       (c) Quality Measure Development.--

[[Page S5838]]

       (1) In general.--Section 1890(b)(1)(A) of the Social 
     Security Act (42 U.S.C. 1395aaa(b)(1)(A)) is amended--
       (A) in clause (ii), by striking ``and'' at the end; and
       (B) by adding at the end the following new clause:
       ``(iv) that address conditions described in section 5(g) of 
     the Empowering Medicare Patient Choices Act and regional 
     practice variations under this title; and''.
       (2) Conforming amendment.--Section 1890(d) of the Social 
     Security Act (42 U.S.C. 1395aaa(d)) is amended--
       (A) by inserting ``(other than subsection (b)(1)(A)(iv))'' 
     after ``this section''; and
       (B) by adding at the end the following new sentence: ``For 
     provisions relating to funding for the duties described in 
     subsection (b)(1)(A)(iv), see section 5(l) of the Empowering 
     Medicare Patient Choices Act.''.

     SEC. 5. ESTABLISHMENT OF SHARED DECISION MAKING PILOT PROGRAM 
                   UNDER THE MEDICARE PROGRAM.

       (a) In General.--Not later than 12 months after the date of 
     enactment of this Act, the Secretary shall establish a pilot 
     program to provide for the phased-in development, 
     implementation, and evaluation of shared decision making 
     under the Medicare program using patient decision aids to 
     meet the objective of improving the understanding by Medicare 
     beneficiaries of their medical treatment options, as compared 
     to comparable Medicare beneficiaries who do not participate 
     in a shared decision making process using patient decision 
     aids.
       (b) Initial Implementation (Phase I).--
       (1) In general.--During the initial implementation of the 
     pilot program under this section (referred to in this section 
     as ``Phase I'' of the pilot program), the Secretary shall 
     enroll in the pilot program not more than 15 eligible 
     providers who have experience in implementing, and have 
     invested in the necessary infrastructure to implement, shared 
     decision making using patient decision aids for a period of 3 
     years.
       (2) Application.--An eligible provider seeking to 
     participate in the pilot program during phase I shall submit 
     to the Secretary an application at such time and containing 
     such information as the Secretary may require.
       (3) Preference.--In enrolling eligible providers in the 
     pilot program during phase I, the Secretary shall give 
     preference to eligible providers that--
       (A) have documented experience in using patient decision 
     aids for the conditions identified in subsection (g) and in 
     using shared decision making;
       (B) have the necessary information technology 
     infrastructure to collect the information required by the 
     Secretary for reporting purposes;
       (C) are trained in how to use patient decision aids and 
     shared decision making; and
       (D) would be eligible to receive financial assistance as a 
     Shared Decision Making Resource Center under subsection (c).
       (c) Shared Decision Making Resource Centers.--
       (1) In general.--The Secretary shall provide financial 
     assistance for the establishment and support of Shared 
     Decision Making Resource Centers (referred to in this section 
     as ``centers'') to provide technical assistance to eligible 
     providers and to develop and disseminate best practices and 
     other information to support and accelerate adoption, 
     implementation, and effective use of patient decision aids 
     and shared decision making by eligible providers under the 
     Medicare program.
       (2) Affiliation.--Centers shall be affiliated with a United 
     States-based organization or group that applies for and is 
     awarded financial assistance under this subsection. The 
     Secretary shall provide financial assistance to centers under 
     this subsection on the basis of merit.
       (3) Objectives.--The objective of a center is to enhance 
     and promote the adoption of patient decision aids and shared 
     decision making through--
       (A) providing assistance to eligible providers with the 
     implementation and effective use of, and training on, patient 
     decision aids;
       (B) the dissemination of best practices and research on the 
     implementation and effective use of patient decision aids; 
     and
       (C) providing assistance to eligible providers applying to 
     participate or participating in phase II of the pilot program 
     under this section or under section 1899 of the Social 
     Security Act, as added by section 6.
       (4) Regional assistance.--Each center shall aim to provide 
     assistance and education to all eligible providers in a 
     region, including direct assistance to the following eligible 
     providers:
       (A) Public or not-for-profit hospitals or critical access 
     hospitals (as defined in section 1861 (mm)(1) of the Social 
     Security Act (42 U.S.C. 1395x(mm)(1)).
       (B) Federally qualified health centers (as defined in 
     section 1861(aa)(4) of the Social Security Act (42 U.S.C. 
     1395x(aa)(4)).
       (C) Entities that are located in a rural area or in area 
     that serves uninsured, underinsured, and medically 
     underserved individuals (regardless of whether such area is 
     urban or rural).
       (D) Individual or small group practices (or a consortium 
     thereof) that are primarily focused on primary care.
       (5) Financial assistance.--
       (A) In general.--The Secretary may provide financial 
     assistance for a period of 8 years to any regional center 
     established or supported under this subsection.
       (B) Cost-sharing requirement.--
       (i) In general.--Except as provided in clause (ii), the 
     Secretary shall not provide as financial assistance under 
     this subsection more than 50 percent of the capital and 
     annual operating and maintenance funds required to establish 
     and support such a center.
       (ii) Waiver of cost-sharing requirement.--The Secretary may 
     waive the limitation under clause (i) if the Secretary 
     determines that, as a result of national economic conditions, 
     such limitation would be detrimental to the pilot program 
     under this section. If the Secretary waives such limitation 
     under the preceding sentence, the Secretary shall submit to 
     Congress a report containing the Secretary's justification 
     for such waiver.
       (6) Notice of program description and availability of 
     funds.--The Secretary shall publish in the Federal Register, 
     not later than 12 months after the date of the enactment of 
     this Act, a draft description of a program for establishing 
     and supporting regional centers under this subsection. Such 
     draft description shall include the following:
       (A) A detailed explanation of the program and the program 
     goals.
       (B) Procedures to be followed by applicants for financial 
     assistance.
       (C) Criteria for determining which applicants are qualified 
     to receive financial assistance.
       (D) Maximum support levels expected to be available to 
     centers under the program.
       (7) Application review.--The Secretary shall review each 
     application for financial assistance under this subsection 
     based on merit. In making a decision whether to approve such 
     application and provide financial assistance, the Secretary 
     shall consider at a minimum the merits of the application, 
     including those portions of the application regarding--
       (A) the ability of the applicant to provide assistance to 
     particular categories of eligible providers with respect to 
     the implementation and effective use of, and training on, 
     patient decision aids;
       (B) the geographical diversity and extent of the service 
     area of the applicant; and
       (C) the percentage of funding for the center that would be 
     provided as financial assistance under this subsection and 
     the amount of any funding or in-kind commitment from sources 
     of funding in addition to the financial assistance provided 
     under this subsection.
       (8) Biennial evaluation.--Each center which receives 
     financial assistance under this subsection shall be evaluated 
     biennially by an evaluation panel appointed by the Secretary. 
     Each such evaluation panel shall be composed of private 
     experts, none of whom shall be connected with the center 
     involved, and officials of the Federal Government. Each 
     evaluation panel shall measure the performance of the center 
     involved against the objectives specified in paragraph (3). 
     The Secretary shall not continue to provide financial 
     assistance to a center under this subsection unless the most 
     recent evaluation under this paragraph with respect to the 
     center is overall positive.
       (d) Expanded Implementation (phase II).--
       (1) In general.--Subject to paragraph (2), during the 3-
     year period beginning after the completion of phase I of the 
     pilot program (referred to in this section as ``phase II'' of 
     the pilot program), the Secretary shall enroll additional 
     eligible providers to implement shared decision making using 
     patient decision aids under the pilot program under this 
     section. The Secretary may allow eligible providers to enroll 
     in the pilot program on a regular basis during phase II.
       (2) Contingency.--The Secretary shall not implement phase 
     II of the pilot program if the Secretary finds, not later 
     than 90 days after the date of submittal of the interim 
     report under subsection (i)(2)(A), that the continued 
     implementation of shared decision making is not in the best 
     interest of Medicare beneficiaries.
       (3) Preference.--In enrolling eligible providers in the 
     pilot program during phase II, the Secretary shall include, 
     to the extent practicable, eligible providers that--
       (A) have or can acquire the infrastructure necessary to 
     implement shared decision making supported by patient 
     decision aids approved by the expert panel established under 
     section 4(b) in a timely manner;
       (B) have training in the use of patient decision aids or 
     will participate in training for health care professionals 
     who will be involved in such use (as specified by the 
     Secretary); or
       (C) represent high cost areas or high practice variation 
     States under the Medicare program, and the District of 
     Columbia.
       (e) Guidance.--The Secretary may, in consultation with the 
     expert panel established under section 4(b), issue guidance 
     to eligible providers participating in the pilot program 
     under this section on the use of patient decision aids 
     approved by the expert panel.
       (f) Requirements.--
       (1) Implementation of approved patient decision aids.--
       (A) In general.--During phase II of the pilot program under 
     this section, an eligible provider participating in the pilot 
     program shall incorporate 1 or more patient decision aids 
     approved by the expert panel established under section 4(b) 
     in furnishing items and services to Medicare beneficiaries 
     with respect to 1 or more of the conditions identified in 
     subsection (g), together with ongoing support involved in 
     furnishing such items and services.

[[Page S5839]]

       (B) Defined clinical process.--During each phase of the 
     pilot program under this section, the eligible provider shall 
     establish and implement a defined clinical process under 
     which, in the case of a Medicare beneficiary with 1 or more 
     of such conditions, the eligible provider offers the Medicare 
     beneficiary shared decision making (supported by such a 
     patient decision aid) and collects information on the quality 
     of patient decision making with respect to the Medicare 
     beneficiary.
       (2) Follow-up counseling visit.--
       (A) In general.--During each phase of the pilot program 
     under this section, an eligible provider participating in the 
     pilot program under this section shall routinely schedule 
     Medicare beneficiaries for a counseling visit after the 
     viewing of such a patient decision aid to answer any 
     questions the beneficiary may have with respect to the 
     medical care of the condition involved and to assist the 
     beneficiary in thinking through how their preferences and 
     concerns relate to their medical care.
       (B) Payment for follow-up counseling visit.--The Secretary 
     shall establish procedures for making payments for such 
     counseling visits provided to Medicare beneficiaries during 
     each phase of the pilot program under this section. Such 
     procedures shall provide for the establishment--
       (i) of a code (or codes) to represent such services; and
       (ii) of a single payment amount for such service that 
     includes the professional time of the health care provider 
     and a portion of the reasonable costs of the infrastructure 
     of the eligible provider.
       (C) Limitation.--In the case of an eligible provider that 
     is a Medicare Advantage plan, such eligible provider may not 
     receive payment for such services.
       (3) Waiver of coinsurance.--The Secretary shall establish 
     procedures under which an eligible provider participating in 
     the pilot program under this section may, in the case of a 
     low-income Medicare beneficiary (as determined by the 
     Secretary), waive any coinsurance or copayment that would 
     otherwise apply for the follow-up counseling visit provided 
     to such Medicare beneficiary under paragraph (2).
       (4) Costs of implementation.--
       (A) In general.--Subject to subparagraph (B), during each 
     phase of the pilot program, an eligible provider 
     participating in the pilot program shall be responsible for 
     the costs of selecting, purchasing, and incorporating such 
     patient decision aids into the group practice, reporting data 
     on quality measures selected under subsection (h)(1), and 
     recording outcomes under the pilot program.
       (B) Financial support.--During each such phase, the 
     Secretary may, in addition to payments for counseling visits 
     under paragraph (2), provide financial support to an eligible 
     provider participating in the pilot program to acquire the 
     infrastructure necessary to participate in the pilot program, 
     including the development of clinical pathways to assure that 
     Medicare beneficiaries have access to high-quality shared 
     decision making, the reporting of data on quality measures 
     selected under subsection (h)(1), and the recording of 
     outcomes under the pilot program after phase I of the pilot 
     program (as determined appropriate by the Secretary).
       (g) Preference Sensitive Care Described.--The patient 
     decision aids approved under section 4(b)(2)(A) shall, to the 
     extent practicable, include patient decision aids for medical 
     care of the following conditions:
       (1) Arthritis of the hip and knee.
       (2) Chronic back pain.
       (3) Chest pain (stable angina).
       (4) Enlarged prostate (benign prostatic hypertrophy, or 
     BPH).
       (5) Early-stage prostate cancer.
       (6) Early-stage breast cancer.
       (7) End-of-life care.
       (8) Peripheral vascular disease.
       (9) Gall stones.
       (10) Threat of stroke from carotid artery disease.
       (11) Any other condition the Secretary identifies as 
     appropriate.
       (h) Quality Measures.--
       (1) Selection.--
       (A) In general.--During each phase of the pilot program, 
     the Secretary shall measure the quality and implementation of 
     shared decision making. For purposes of making such 
     measurements, the Secretary shall select, from among those 
     quality measures recommended by the expert panel under 
     section 4(b)(2)(C), consensus-based quality measures that 
     assess Medicare beneficiaries' knowledge of the options for 
     medical treatment relevant to their medical condition, as 
     well as the benefits and drawbacks of those medical treatment 
     options, and the Medicare beneficiaries' goals and concerns 
     regarding their medical care.
       (B) Risk adjustment.--In order to ensure accurate 
     measurement across quality measures and eligible providers, 
     the Secretary may risk adjust the quality measures selected 
     under this paragraph to control for external factors, such as 
     cognitive impairment, dementia, and literacy.
       (2) Reporting data on measures.--During each such phase, an 
     eligible provider participating in the pilot program shall 
     report to the Secretary data on quality measures selected 
     under paragraph (1) in accordance with procedures established 
     by the Secretary.
       (3) Feedback on measures.--During each such phase, the 
     Secretary shall provide confidential reports to eligible 
     providers participating in the pilot program on the 
     performance of the eligible provider on quality measures 
     selected by the Secretary under paragraph (1), the aggregate 
     performance of all eligible providers participating in the 
     pilot program, and any improvements in such performance.
       (i) Evaluations and Reports.--
       (1) Independent evaluation.--The Secretary shall enter into 
     a contract with an entity that has knowledge of shared 
     decision making programs and demonstrated experience in the 
     evaluation of such programs for the conduct of an independent 
     evaluation of each phase of the pilot program under this 
     section.
       (2) Reports by entity conducting independent evaluation.--
       (A) Interim report.--Not later than 2 years after the 
     implementation of phase I of the pilot program, the entity 
     with a contract under paragraph (1) shall submit to the 
     Secretary a report on the initial results of the independent 
     evaluation conducted under such paragraph.
       (B) Final report.--Not later then 4 years after the 
     implementation of phase II of the pilot program, such entity 
     shall submit to the Secretary a report on the final results 
     of such independent evaluation.
       (C) Contents of report.--Each report submitted under this 
     paragraph shall--
       (i) include an assessment of--

       (I) quality measures selected under subsection (h)(1);
       (II) Medicare beneficiary and health care provider 
     satisfaction under the applicable phase of the pilot program;
       (III) utilization of medical services for Medicare 
     beneficiaries with 1 or more of the conditions described in 
     subsection (g) and other Medicare beneficiaries as determined 
     appropriate by the Secretary;
       (IV) appropriate utilization of shared decision making by 
     eligible providers under the applicable phase of the pilot 
     program;
       (V) savings to the Medicare program under title XVIII of 
     the Social Security Act; and
       (VI) the costs to eligible providers participating in the 
     pilot program of selecting, purchasing, and incorporating 
     approved patient decision aids and meeting reporting 
     requirements under the applicable phase of the pilot program; 
     and

       (ii) identify the characteristics of individual eligible 
     providers that are most effective in implementing shared 
     decision making under the applicable phase of the pilot 
     program.
       (3) Report by the secretary.--Not later than 12 months 
     after the completion of phase II of the pilot program, the 
     Secretary shall submit to Congress a report on the pilot 
     program that includes--
       (A) the results of the independent evaluation conducted 
     under paragraph (2);
       (B) an evaluation of the impact of the pilot program under 
     this section, including the impact--
       (i) of the use of patient decision aids approved by the 
     expert panel established under section 4(b) for the medical 
     care of the conditions described in subsection (g);
       (ii) on expenditures for such conditions under the Medicare 
     program, including a comparison of such expenditures for such 
     conditions where such patient decision aids were used to such 
     expenditures for such conditions where such patient decision 
     aids were not used; and
       (iii) on Medicare beneficiaries, including the 
     understanding by beneficiaries of the options for medical 
     care presented, concordance between beneficiary values and 
     the medical care received, the mode of approved patient 
     decision aid used (such as Internet, videos, and pamphlets), 
     the timing of the delivery of such approved patient decision 
     aid (such as the date of the initial diagnosis), and 
     beneficiary and health care provider satisfaction with the 
     shared decision making process;
       (C) an evaluation of which eligible providers are most 
     effective at implementing patient decision aids and assisting 
     Medicare beneficiaries in making informed decisions on 
     medical care; and
       (D) recommendations for such legislation and administrative 
     action as the Secretary determines appropriate.
       (j) Savings.--
       (1) In general.--Subject to paragraph (2), not later than 2 
     years after the implementation of phase I of the pilot 
     program, and annually thereafter for the duration of phase I 
     and the first 2 years of phase II, the Secretary shall 
     determine if there were any savings to the Medicare program 
     as a result of such implementation during the preceding year 
     (or years, if applicable). In the case where the Secretary 
     determines there were such savings, the Secretary shall use 
     such savings as follows:
       (A) Fifty percent of such savings shall be used to provide 
     bonus payments to eligible providers participating in the 
     pilot program who achieve high quality shared decision making 
     (as measured by the level of participation of Medicare 
     beneficiaries in the shared decision making process and high 
     scores by the eligible provider on quality measures selected 
     under subsection (h)(1)).
       (B) Twenty-five percent of such savings shall be placed in 
     a Shared Decision Making Trust Fund established by the 
     Secretary, which shall be used to expand participation in the 
     pilot program to providers of services and suppliers in 
     additional settings (as determined appropriate by the 
     Secretary) by--
       (i) providing financial assistance under subsection (c); 
     and

[[Page S5840]]

       (ii) providing for the development of quality measures not 
     already selected under subsection (h)(1) to assess the impact 
     of shared decision making on the quality of patient care or 
     the improvement of such quality measures already selected.
       (C) Twenty-five percent of such savings shall be retained 
     by the Medicare program.
       (2) Retention of savings by the medicare program.--In the 
     case where the Secretary determines there are savings to the 
     Medicare program as a result of the implementation of the 
     pilot program during a year (beginning with the third year of 
     phase II), 100 percent of such savings shall be retained by 
     the Medicare program.
       (k) Waiver.--The Secretary may waive such provisions of 
     titles XI and XVIII of the Social Security Act as may be 
     necessary to carry out the pilot program under this section.
       (l) Funding.--For purposes of carrying out section 4(a), 
     implementing the pilot program under this section (including 
     costs incurred in conducting the evaluation under subsection 
     (i)), and carrying out section 1890(b)(1)(A)(iv) of the 
     Social Security Act, as added by section 4(c), the Secretary 
     shall provide for the transfer from the Federal Hospital 
     Insurance Trust Fund established under section 1817 of the 
     Social Security Act (42 U.S.C. 1395i) to the Centers for 
     Medicare & Medicaid Services Program Management Account of 
     $300,000,000 for the period of fiscal years 2010 through 
     2017.

     SEC. 6. ESTABLISHMENT OF SHARED DECISION MAKING STANDARDS AND 
                   REQUIREMENTS IN MEDICARE.

       Title XVIII of the Social Security Act (42 U.S.C. 1395 et 
     seq.) is amended by adding at the end the following new 
     section:


  ``establishment of shared decision making standards and requirements

       ``Sec. 1899.  (a) In General.--Based on the findings of 
     phases I and II of the pilot program under section 5 of the 
     Empowering Medicare Patient Choices Act the Secretary shall 
     promulgate regulations that--
       ``(1) specify for which preference sensitive conditions 
     beneficiaries should, subject to the succeeding provisions of 
     this section, participate in shared decision making;
       ``(2) require providers of services and suppliers to make 
     sure that beneficiaries receive patient decision aids as 
     appropriate; and
       ``(3) specify a process for beneficiaries to elect not to 
     use such patient decision aids.
       ``(b) Penalty for Not Using Shared Decision Making.--
     Notwithstanding any other provision of this title, the 
     Secretary shall promulgate such regulations and issue such 
     guidance as may be necessary to reduce by 20 percent the 
     amount of payment under this title that would otherwise apply 
     to an item or service specified by the Secretary if the 
     patient does not receive a patient decision aid prior to such 
     item or service being furnished (except in the case where the 
     beneficiary has elected not to use such patient decision aid 
     under the process specified under subsection (a)(3)).
       ``(c) Secretarial Authority to Waive Application of This 
     Section.--The Secretary may waive the application of this 
     section to an item or service under this title if the 
     Secretary determines either of the following:
       ``(1) Medical societies and others have established 
     evidence-based transparent standards incorporating patient 
     decision aids and shared decision making into the standard of 
     patient care for preference sensitive conditions.
       ``(2) Shared decision making is not in the best interest of 
     beneficiaries.''.
                                 ______