H. R. 3590—409 
‘‘(1) LESS THAN $10,000,000.—If the amount of appropriations 
for this part in a fiscal year is less than $10,000,000, the 
Secretary shall divide such funding evenly among only those 
States that have 1 or more trauma centers eligible for funding 
under section 1241(b)(3)(A). 
‘‘(2) LESS THAN $20,000,000.—If the amount of appropriations 
in a fiscal year is less than $20,000,000, the Secretary shall 
divide such funding evenly among only those States that have 
1 or more trauma centers eligible for funding under subpara-
graphs (A) and (B) of section 1241(b)(3). 
‘‘(3) LESS THAN $30,000,000.—If the amount of appropriations 
for this part in a fiscal year is less than $30,000,000, the 
Secretary shall divide such funding evenly among only those 
States that have 1 or more trauma centers eligible for funding 
under section 1241(b)(3). 
‘‘(4) $30,000,000 OR MORE.—If the amount of appropriations 
for this part in a fiscal year is $30,000,000 or more, the Sec-
retary shall divide such funding evenly among all States. 
‘‘SEC. 1282. AUTHORIZATION OF APPROPRIATIONS. 
‘‘For the purpose of carrying out this part, there is authorized 
to be appropriated $100,000,000 for each of fiscal years 2010 
through 2015.’’. 
SEC. 3506. PROGRAM TO FACILITATE SHARED DECISIONMAKING. 
Part D of title IX of the Public Health Service Act, as amended 
by section 3503, is further amended by adding at the end the 
following: 
‘‘SEC. 936. PROGRAM TO FACILITATE SHARED DECISIONMAKING. 
‘‘(a) PURPOSE.—The purpose of this section is to facilitate 
collaborative processes between patients, caregivers or authorized 
representatives, and clinicians that engages the patient, caregiver 
or authorized representative in decisionmaking, provides patients, 
caregivers or authorized representatives with information about 
trade-offs among treatment options, and facilitates the incorporation 
of patient preferences and values into the medical plan. 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) PATIENT DECISION AID.—The term ‘patient decision aid’ 
means an educational tool that helps patients, caregivers or 
authorized representatives 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 evi-
dence, circumstances, beliefs, and preferences. 
‘‘(2) PREFERENCE SENSITIVE CARE.—The term ‘preference 
sensitive care’ means medical care for which the clinical evi-
dence 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, caregivers 
or authorized representatives regarding the benefits, harms 
and scientific evidence for each treatment option, the use of 
such care should depend on the informed patient choice among 
clinically appropriate treatment options. 
‘‘(c) ESTABLISHMENT OF INDEPENDENT STANDARDS FOR PATIENT 
DECISION AIDS FOR PREFERENCE SENSITIVE CARE.— 
‘‘(1) CONTRACT WITH ENTITY TO ESTABLISH STANDARDS AND 
CERTIFY PATIENT DECISION AIDS.—
H. R. 3590—410 
‘‘(A) IN
GENERAL.—For purposes of supporting con-
sensus-based standards for patient decision aids for pref-
erence sensitive care and a certification process for patient 
decision aids for use in the Federal health programs and 
by other interested parties, the Secretary shall have in 
effect a contract with the entity with a contract under 
section 1890 of the Social Security Act. Such contract shall 
provide that the entity perform the duties described in 
paragraph (2). 
‘‘(B) TIMING FOR FIRST CONTRACT.—As soon as prac-
ticable after the date of the enactment of this section, 
the Secretary shall enter into the first contract under 
subparagraph (A). 
‘‘(C) PERIOD OF CONTRACT.—A contract under subpara-
graph (A) shall be for a period of 18 months (except such 
contract may be renewed after a subsequent bidding 
process). 
‘‘(2) DUTIES.—The following duties are described in this 
paragraph: 
‘‘(A) DEVELOP AND IDENTIFY STANDARDS FOR PATIENT 
DECISION AIDS.—The entity shall synthesize evidence and 
convene a broad range of experts and key stakeholders 
to develop and identify consensus-based standards to 
evaluate patient decision aids for preference sensitive care. 
‘‘(B) ENDORSE PATIENT DECISION AIDS.—The entity shall 
review patient decision aids and develop a certification 
process whether patient decision aids meet the standards 
developed and identified under subparagraph (A). The 
entity shall give priority to the review and certification 
of patient decision aids for preference sensitive care. 
‘‘(d) PROGRAM TO DEVELOP, UPDATE AND PATIENT DECISION 
AIDS TO ASSIST HEALTH CARE PROVIDERS AND PATIENTS.— 
‘‘(1) IN
GENERAL.—The Secretary, acting through the 
Director, and in coordination with heads of other relevant agen-
cies, such as the Director of the Centers for Disease Control 
and Prevention and the Director of the National Institutes 
of Health, shall establish a program to award grants or con-
tracts— 
‘‘(A) to develop, update, and produce patient decision 
aids for preference sensitive care to assist health care 
providers in educating patients, caregivers, and authorized 
representatives concerning the relative safety, relative 
effectiveness (including possible health outcomes and 
impact on functional status), and relative cost of treatment 
or, where appropriate, palliative care options; 
‘‘(B) to test such materials to ensure such materials 
are balanced and evidence based in aiding health care 
providers and patients, caregivers, and authorized rep-
resentatives to make informed decisions about patient care 
and can be easily incorporated into a broad array of practice 
settings; and 
‘‘(C) to educate providers on the use of such materials, 
including through academic curricula. 
‘‘(2) REQUIREMENTS FOR PATIENT DECISION AIDS.—Patient 
decision aids developed and produced pursuant to a grant or 
contract under paragraph (1)—
H. R. 3590—411 
‘‘(A) shall be designed to engage patients, caregivers, 
and authorized representatives in informed decisionmaking 
with health care providers; 
‘‘(B) shall present up-to-date clinical evidence about 
the risks and benefits of treatment options in a form and 
manner that is age-appropriate and can be adapted for 
patients, caregivers, and authorized representatives from 
a variety of cultural and educational backgrounds to reflect 
the varying needs of consumers and diverse levels of health 
literacy; 
‘‘(C) shall, where appropriate, explain why there is 
a lack of evidence to support one treatment option over 
another; and 
‘‘(D) shall address health care decisions across the age 
span, including those affecting vulnerable populations 
including children. 
‘‘(3) DISTRIBUTION.—The Director shall ensure that patient 
decision aids produced with grants or contracts under this 
section are available to the public. 
‘‘(4) NONDUPLICATION
OF
EFFORTS.—The Director shall 
ensure that the activities under this section of the Agency 
and other agencies, including the Centers for Disease Control 
and Prevention and the National Institutes of Health, are free 
of unnecessary duplication of effort. 
‘‘(e) 
GRANTS
TO
SUPPORT
SHARED
DECISIONMAKING 
IMPLEMENTATION.— 
‘‘(1) IN GENERAL.—The Secretary shall establish a program 
to provide for the phased-in development, implementation, and 
evaluation of shared decisionmaking using patient decision aids 
to meet the objective of improving the understanding of patients 
of their medical treatment options. 
‘‘(2) SHARED DECISIONMAKING RESOURCE CENTERS.— 
‘‘(A) IN GENERAL.—The Secretary shall provide grants 
for the establishment and support of Shared Decision-
making Resource Centers (referred to in this subsection 
as ‘Centers’) to provide technical assistance to 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 decisionmaking by providers. 
‘‘(B) OBJECTIVES.—The objective of a Center is to 
enhance and promote the adoption of patient decision aids 
and shared decisionmaking through— 
‘‘(i) providing assistance to eligible providers with 
the implementation and effective use of, and training 
on, patient decision aids; and 
‘‘(ii) the dissemination of best practices and 
research on the implementation and effective use of 
patient decision aids. 
‘‘(3) SHARED DECISIONMAKING PARTICIPATION GRANTS.— 
‘‘(A) IN GENERAL.—The Secretary shall provide grants 
to health care providers for the development and 
implementation of shared decisionmaking techniques and 
to assess the use of such techniques. 
‘‘(B) PREFERENCE.—In order to facilitate the use of 
best practices, the Secretary shall provide a preference 
in making grants under this subsection to health care
H. R. 3590—412 
providers who participate in training by Shared Decision-
making Resource Centers or comparable training. 
‘‘(C) LIMITATION.—Funds under this paragraph shall 
not be used to purchase or implement use of patient deci-
sion aids other than those certified under the process 
identified in subsection (c). 
‘‘(4) GUIDANCE.—The Secretary may issue guidance to 
eligible grantees under this subsection on the use of patient 
decision aids. 
‘‘(f) FUNDING.—For purposes of carrying out this section there 
are authorized to be appropriated such sums as may be necessary 
for fiscal year 2010 and each subsequent fiscal year.’’. 
SEC. 3507. PRESENTATION OF PRESCRIPTION DRUG BENEFIT AND 
RISK INFORMATION. 
(a) IN GENERAL.—The Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’), acting through the 
Commissioner of Food and Drugs, shall determine whether the 
addition of quantitative summaries of the benefits and risks of 
prescription drugs in a standardized format (such as a table or 
drug facts box) to the promotional labeling or print advertising 
of such drugs would improve health care decisionmaking by clini-
cians and patients and consumers. 
(b) REVIEW AND CONSULTATION.—In making the determination 
under subsection (a), the Secretary shall review all available sci-
entific evidence and research on decisionmaking and social and 
cognitive psychology and consult with drug manufacturers, clini-
cians, patients and consumers, experts in health literacy, represent-
atives of racial and ethnic minorities, and experts in women’s 
and pediatric health. 
(c) REPORT.—Not later than 1 year after the date of enactment 
of this Act, the Secretary shall submit to Congress a report that 
provides— 
(1) the determination by the Secretary under subsection 
(a); and 
(2) the reasoning and analysis underlying that determina-
tion. 
(d) AUTHORITY.—If the Secretary determines under subsection 
(a) that the addition of quantitative summaries of the benefits 
and risks of prescription drugs in a standardized format (such 
as a table or drug facts box) to the promotional labeling or print 
advertising of such drugs would improve health care decisionmaking 
by clinicians and patients and consumers, then the Secretary, not 
later than 3 years after the date of submission of the report under 
subsection (c), shall promulgate proposed regulations as necessary 
to implement such format. 
(e) CLARIFICATION.—Nothing in this section shall be construed 
to restrict the existing authorities of the Secretary with respect 
to benefit and risk information. 
SEC. 3508. DEMONSTRATION PROGRAM TO INTEGRATE QUALITY 
IMPROVEMENT AND PATIENT SAFETY TRAINING INTO 
CLINICAL EDUCATION OF HEALTH PROFESSIONALS. 
(a) IN GENERAL.—The Secretary may award grants to eligible 
entities or consortia under this section to carry out demonstration 
projects to develop and implement academic curricula that 
integrates quality improvement and patient safety in the clinical