137 
rected to providers or others who may make decisions 
about the use of prescription pharmaceuticals (including 
the provision of product samples, free trials, and starter 
kits).’’. 
(b) CONFORMING AMENDMENT.—The table of sec-
tions for such part IX is amended by adding after the 
item relating to section 280H the following new item: 
‘‘Sec. 280I. One time disallowance of deduction for certain prescription phar-
maceuticals advertising and promotional expenses.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to taxable years beginning with 
or within calendar years beginning at least 4 years after 
the date of the enactment of this Act. 
SEC. 702. ENHANCED NEW DRUG AND DEVICE APPROVAL. 
(a) IN GENERAL.— 
(1) NEW DRUGS.—Section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) is 
amended by adding at the end the following: 
‘‘(o)(1) The sponsor of a new drug application under 
subsection (b) may include as part of such application a 
full report of an investigation which has been made to 
show, with respect to the new drug that is the subject of 
the application— 
‘‘(A) the population for whom the drug is ap-
propriate; and 
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‘‘(B) the effectiveness of the drug when com-
pared to the effectiveness of drugs on the market as 
of the date that the application is submitted. 
‘‘(2) If a sponsor of a new drug application under 
subsection (b) includes in such application the report de-
scribed under paragraph (1) then, notwithstanding any 
other provision of law, the Secretary shall apply section 
505A(b) to the drug that is the subject of such application 
in the same manner as the Secretary applies such section 
to a new drug in the pediatric population that is the sub-
ject of a study described in such section. 
‘‘(3) If a sponsor of a new drug application under 
subsection (b) does not include in such application the re-
port described under paragraph (1) then, notwithstanding 
any other provision of law, the Secretary shall require 
that— 
‘‘(A) all promotional material with respect to 
such drug include the following disclosure: ‘This 
drug has not been proven to be more effective than 
other drugs on the market for any condition or ill-
ness mentioned in this advertisement.’; and 
‘‘(B) such disclosure— 
‘‘(i) appears at the beginning and end of 
any audio and visual promotional material; 
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‘‘(ii) constitutes not less than 20 percent of 
the time of any audio and visual promotional 
material; and 
‘‘(iii)(I) in any promotional material, in-
cludes a clear and conspicuous printed state-
ment that is larger than other print used in 
such promotional material; and 
‘‘(II) in any audio and visual promotional 
material, includes such statement in audio as 
well as visual format.’’. 
(2) NEW DEVICES.—Section 515(c) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360e) is amended by adding at the end the fol-
lowing: 
‘‘(5)(A) A person that files a report seeking pre-
market approval under this subsection may include as part 
of such report a full description of an investigation which 
has been made to show, with respect to the device that 
is the subject of the report— 
‘‘(i) the population for whom the device is ap-
propriate; and 
‘‘(ii) the effectiveness of the device when com-
pared to the effectiveness of devices on the market 
as of the date that the report is submitted. 
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‘‘(B) If a person that files a report seeking premarket 
approval under this subsection includes in such report the 
description referred to under subparagraph (A), then the 
Secretary shall certify to the Director of the United States 
Patent and Trademark Office that such person included 
such description in such report so that the Director may 
extend the patent with respect to such device under section 
702(b) of the Healthy Americans Act. 
‘‘(C) If a person that files a report seeking premarket 
approval under this subsection does not include in such 
report the description referred to under subparagraph (A) 
then, notwithstanding any other provision of law, the Sec-
retary shall require that— 
‘‘(i) all promotional material with respect to 
such device include the following disclosure: ‘This 
device has not been proven to be more effective than 
other devices on the market for any condition or ill-
ness mentioned in this advertisement.’; and 
‘‘(ii) such disclosure— 
‘‘(I) appears at the beginning and end of 
any audio and visual promotional material; 
‘‘(II) constitutes not less than 20 percent 
of the time of any audio and visual promotional 
material; and 
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‘‘(III)(aa) in any promotional material, in-
cludes a clear and conspicuous printed state-
ment that is larger than other print used in 
such promotional material; and 
‘‘(bb) in any audio and visual promotional 
material, includes such statement in audio as 
well as visual format.’’. 
(b) EXTENSION OF DEVICE PATENTS.—If the Direc-
tor of the United States Patent and Trademark Office re-
ceives a certification from the Secretary pursuant to sec-
tion 515(c)(5) of the Federal Food, Drug, and Cosmetic 
Act (as added under subsection (a)), the Director shall 
extend, for a period of 2 years, the patent in effect with 
respect to such device under title 35 of the United States 
Code. 
(c) EFFECTIVE DATE.—This section shall apply to 
new drug applications filed under section 505(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b) 
and to applications for premarket approval of devices 
under section 515 of such Act (21 U.S.C. 350e) 180 days 
after the date of enactment of this Act. 
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142 
SEC. 703. MEDICAL SCHOOLS AND FINDING WHAT WORKS 
IN HEALTH CARE. 
Part B of title IX of the Public Health Service Act 
(42 U.S.C. 299b et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 918. MEDICAL SCHOOLS AND FINDING WHAT WORKS 
IN HEALTH CARE. 
‘‘(a) ESTABLISHMENT OF WEBSITE.—Not later than 
1 year after the date of enactment of the Healthy Ameri-
cans Act, the Agency shall establish an Internet website— 
‘‘(1) on which researchers at medical schools 
and other institutions may post the results of their 
research concerning evidence-informed best practices 
for improving the quality and efficiency of care; and 
‘‘(2) that— 
‘‘(A) includes a description on how to im-
plement such best practices; and 
‘‘(B) clearly identifies the funding source 
for the research. 
‘‘(b) PILOT PROGRAM.— 
‘‘(1) ESTABLISHMENT.—Using the information 
about evidence-informed best practices from the 
website under subsection (a) and other sources, the 
Agency, through the National Research Training 
Program and in consultation with medical schools, 
shall develop a pilot program to establish methods 
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by which medical school curricula and training may 
be updated regularly to reflect best practices to im-
prove quality and efficiency in medical practice. 
‘‘(2) APPLICATION TO PARTICIPATE.—To par-
ticipate in the pilot program, an entity shall— 
‘‘(A) be an accredited medical school; and 
‘‘(B) submit an application at such time, 
in such manner, and containing such informa-
tion as the Secretary may require. 
‘‘(3) PARTICIPANTS.—The Secretary shall en-
sure that not less than 28 medical schools shall be 
included in the pilot program. 
‘‘(4) DURATION; PUBLICATION OF RESULTS.— 
The Agency shall— 
‘‘(A) operate the pilot program for 3 years; 
and 
‘‘(B) not later than 180 days after the 
date of the completion of the pilot program, 
publish and make public the results of the pilot 
program; and 
‘‘(C) include, as part of the published re-
sults under subparagraph (B), recommenda-
tions on how to assure that all medical school 
curricula is updated on a regular basis to re-
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flect best practices to improve quality and effi-
ciency in medical practice.’’. 
SEC. 704. FINDING AFFORDABLE HEALTH CARE PRO-
VIDERS NEARBY. 
(a) IN GENERAL.—Not later than 2 years after the 
date of enactment of this Act, the Secretary, in consulta-
tion with each HHA and health insurance issuers that 
offer a HAPI plan, shall establish an Internet website to 
assist covered individuals with locating health care pro-
viders in their State of residence who provide affordable, 
high-quality health care services. 
(b) QUALITY OF CARE STANDARD.—To develop the 
information displayed on the website with respect to the 
quality of care of a health care provider, the Secretary 
shall— 
(1) on the date of establishment of the website, 
use information on the performance of providers in 
quality initiatives under the Medicare program, in-
cluding demonstration projects, reporting initiatives, 
and pay for performance efforts; and 
(2) not later than 3 years after the date of es-
tablishment of the website, in addition to the infor-
mation used under paragraph (1), use quality of 
care standards developed in consultation with, and 
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similar to standards used by, Medicare quality im-
provement organizations of each State. 
(c) AFFORDABILITY STANDARD.—Not later than 2 
years after the date of enactment of this Act, the Sec-
retary shall, in consultation with health insurance issuers 
that offer a HAPI plan, develop guidelines by which each 
health care provider reports to the Secretary with respect 
to the affordability of services by such provider. The Sec-
retary shall ensure that such guidelines— 
(1) on the date of establishment of such guide-
lines, provide for the reporting of affordability of 
primary care services; and 
(2) by a date that is no later than 3 years after 
the date of enactment of this Act, provide for the re-
porting of other services. 
TITLE VIII—ENHANCED HEALTH 
CARE VALUE 
SEC. 801. SHORT TITLE. 
This title may be cited as the ‘‘Enhanced Health Care 
Value for All Act of 2007’’. 
SEC. 802. RESEARCH ON COMPARATIVE EFFECTIVENESS 
OF HEALTH CARE ITEMS AND SERVICES. 
(a) EXPANSION
OF SCOPE
OF RESEARCH.—Sub-
section (a) of section 1013 of the Medicare Prescription 
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146 
Drug, Improvement, and Modernization Act of 2003 (Pub-
lic Law 108–173) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘programs established 
under titles XVIII, XIX, and XXI of the 
Social Security Act’’ and inserting ‘‘Fed-
eral health care programs (as defined in 
subparagraph (C))’’; 
(ii) by striking ‘‘shall conduct and 
support research’’ and inserting ‘‘shall con-
duct and support research, which may in-
clude clinical research,’’; 
(iii) in clause (i), by striking ‘‘and’’ at 
the end; 
(iv) in clause (ii), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(v) by adding at the end the following: 
‘‘(iii) gaps in current research which 
may necessitate research beyond system-
atic reviews of existing evidence.’’; 
(B) by adding at the end the following new 
subparagraph: 
‘‘(C) FEDERAL HEALTH CARE PROGRAMS 
DEFINED.—For purposes of this section, the 
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term ‘Federal health care program’ means each 
of the following: 
‘‘(i) Any program established under 
title XVIII, XIX, or XXI of the Social Se-
curity Act. 
‘‘(ii) The Federal employees health 
benefits program under chapter 89 of title 
5, United States Code. 
‘‘(iii) A health program operated 
under title 38, United States Code, by the 
Department of Veterans Affairs. 
‘‘(iv) The TRICARE program under 
chapter 55 of title 10, United States Code. 
‘‘(v) A medical care program of the 
Indian Health Service or of a tribal organi-
zation. 
‘‘(vi) A HAPI plan under the Healthy 
Americans Act.’’; 
(2) in paragraph (2)— 
(A) in subparagraph (C)(i), by striking 
‘‘the programs established’’ and inserting ‘‘Fed-
eral health care programs, including the pro-
grams established’’; 
(B) in subparagraph (C)(ii), by striking 
‘‘and’’ at the end; 
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148 
(C) in subparagraph (C)(iii), by striking 
the period at the end and inserting ‘‘; and’’; 
(D) by inserting after subparagraph (C) 
the following: 
‘‘(iv) shall provide for edu-
cation to physicians, other health 
care providers, and the public 
(including 
patients 
and 
con-
sumers) about the information on 
comparative effectiveness that is 
available as a result of research 
funded under this section.’’; and 
(E) by adding at the end the following: 
‘‘(D) COMPARATIVE EFFECTIVENESS ADVI-
SORY BOARD.— 
‘‘(i) IN GENERAL.—Effective as of the 
date of the enactment of the Enhanced 
Health Care Value for All Act of 2007, the 
stakeholder group consulted for purposes 
of subparagraph (C)(1) shall be known as 
the Comparative Effectiveness Advisory 
Board. Any reference in a law, map, regu-
lation, document, paper, or other record of 
the United States to such stakeholder 
group shall be deemed to be a reference to 
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149 
the Comparative Effectiveness Advisory 
Board. 
‘‘(ii) COMPOSITION OF BOARD.—The 
members of the Comparative Effectiveness 
Advisory Board shall consist of— 
‘‘(I) the Director of the Agency 
for Healthcare Research and Quality; 
and 
‘‘(II) up to 14 additional mem-
bers who shall represent broad con-
stituencies of stakeholders including 
clinicians, patients, researchers, third- 
party payers, consumers of Federal 
and State beneficiary programs, and 
health care industry professionals. 
‘‘(iii) APPOINTMENT; 
TERMS.—The 
Comptroller General of the United States 
shall appoint the members of the Compara-
tive Effectiveness Advisory Board. Each 
member shall be appointed for a term of 2 
years. The members appointed for the first 
term following the date of the enactment 
of the Enhanced Health Care Value for All 
Act of 2007 shall be appointed not later 
than 90 days after such date of enactment. 
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150 
Any member serving on the Advisory 
Board as of the date of the enactment of 
the Enhanced Health Care Value for All 
Act of 2007 may continuing serving 
through the end of the member’s term. 
‘‘(iv) CONFLICTS
OF
INTEREST.—In 
appointing the members of the Compara-
tive Effectiveness Advisory Board (and the 
members of any panel that reports to the 
Board), the Comptroller General of the 
United States shall take into consideration 
any financial conflicts of interest. 
‘‘(E) ADDITIONAL AUTHORITIES.—In addi-
tion to any authorities vested in the Compara-
tive Effectiveness Advisory Board as of the day 
before the date of the enactment of the En-
hanced Health Care Value for All Act of 2007, 
the Comparative Effectiveness Advisory Board 
shall have the following authorities: 
‘‘(i) To provide input on research pri-
orities. 
‘‘(ii) To recommend how to organize 
research funded under this section taking 
into consideration the full range of appro-
priate methodologies, including randomized 
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151 
control trials, practical clinical trials, ob-
servation studies, and synthesis of existing 
research. 
‘‘(iii) To make recommendations on 
how findings resulting from research fund-
ed under this section should be described, 
presented, and disseminated. 
‘‘(iv) To make recommendations to 
the Congress and the Secretary, not later 
than 2 years after the date of the enact-
ment of the Enhanced Health Care Value 
for All Act of 2007, regarding the estab-
lishment of one or more federally-funded 
research and development centers. 
‘‘(v) To identify, consistent with sub-
paragraph (C)(i), highest priorities (such 
as treatments that are highly utilized or 
are for high-cost, chronic illnesses) for re-
search, demonstrations, and evaluations to 
support and improve Federal health care 
programs. 
‘‘(vi) To ensure that such priorities 
are in accordance with the principles de-
scribed in subparagraph (F). 
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152 
‘‘(vii) To establish a clinical peer re-
view advisory panel (comprised of meth-
odologists, health service researchers, and 
medical experts) for each such priority to 
advise the Secretary on validating the 
science and methods used to conduct com-
parative effectiveness studies. 
‘‘(F) PRINCIPLES.—Research conducted or 
supported under this section shall be in accord-
ance with the following principles: 
‘‘(i) INDEPENDENCE.—The setting of 
the agenda and use of the research shall be 
insulated from inappropriate political or 
stakeholder influence. 
‘‘(ii) SCIENTIFIC
CREDIBILITY.—The 
methods for conducting the research shall 
be scientifically based. 
‘‘(iii) TRANSPARENCY.—All aspects of 
the prioritization of research, the conduct 
of the research, and any recommendations 
based on the research shall be carried out 
in a transparent manner. 
‘‘(iv) INCLUSION
OF
INPUT
FROM 
STAKEHOLDERS.—Patients, 
providers, 
health 
care 
consumer 
representatives, 
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153 
health industry representatives, and law-
makers shall be consulted regarding prior-
ities and dissemination of the research.’’; 
(3) in paragraph (3)(C), by adding at the end 
the following: 
‘‘(iii) UPDATES.—The Secretary shall 
make available and disseminate updated 
evaluations, syntheses, and findings under 
this subparagraph not less than every 6 
months.’’; and 
(4) in paragraph (4)(A), by striking ‘‘the pro-
grams established under titles XVIII, XIX, and XXI 
of the Social Security Act’’ and inserting ‘‘the Fed-
eral health care programs’’. 
(b) REPORTS TO CONGRESS.—Such section is further 
amended— 
(1) by redesignating subsection (e) as sub-
section (f); and 
(2) by inserting after subsection (d) the fol-
lowing: 
‘‘(e) REPORTS.—Not later than 1 year after the date 
of the enactment of the Enhanced Health Care Value for 
All Act of 2007, and annually thereafter, the Secretary, 
in consultation with the Comparative Effectiveness Advi-
sory Board, shall submit to Congress a report on the ac-
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154 
tivities conducted under this section. The report submitted 
under this subsection in 2012 shall include a description 
of the total activities conducted under this section since 
the date of the enactment of the Enhanced Health Care 
Value for All Act of 2007, including— 
‘‘(1) an evaluation of the return on the invest-
ment in the program conducted under this section, 
including the overall cost of the program, the sci-
entific knowledge created through the program, and 
the ways in which such knowledge has been used; 
‘‘(2) an evaluation of any backlog of unfunded 
research projects; and 
‘‘(3) an assessment of— 
‘‘(A) how the program is working; 
‘‘(B) the governance structure of the pro-
gram; 
‘‘(C) the ability of the program to include 
public comment and patient perspectives in pri-
ority setting; and 
‘‘(D) the ability of the program to dissemi-
nate findings and conclusions.’’. 
SEC. 803. HEALTH CARE COMPARATIVE EFFECTIVENESS 
RESEARCH TRUST FUND; FINANCING FOR 
TRUST FUND. 
(a) ESTABLISHMENT OF TRUST FUND.— 
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155 
(1) IN GENERAL.—Subchapter A of chapter 98 
of the Internal Revenue Code of 1986 (relating to 
trust fund code) is amended by adding at the end 
the following new section: 
‘‘SEC. 9511. HEALTH CARE COMPARATIVE EFFECTIVENESS 
RESEARCH TRUST FUND. 
‘‘(a) CREATION OF TRUST FUND.—There is estab-
lished in the Treasury of the United States a trust fund 
to be known as the ‘Health Care Comparative Effective-
ness Research Trust Fund’ (hereinafter in this section re-
ferred to as the ‘Trust Fund’), consisting of such amounts 
as may be appropriated or credited to such Trust Fund 
as provided in this section and section 9602(b). 
‘‘(b) TRANSFERS TO FUND.—There are hereby ap-
propriated to the Trust Fund the following: 
‘‘(1) Amounts equivalent to the net revenues re-
ceived in the Treasury from the fees imposed under 
subchapter B of chapter 34 (relating to fees on 
health insurance and self-insured plans). 
‘‘(2) Subject to subsection (c)(2), for each fiscal 
year beginning with fiscal year 2008, amounts deter-
mined by the Secretary of Health and Human Serv-
ices to be equivalent to fair share amount deter-
mined under subsection (c) multiplied by the average 
number of individuals entitled to benefits under part 
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A, or enrolled under part B, of title XVIII of the So-
cial Security Act during such fiscal year. 
The amounts appropriated under paragraph (2) shall be 
transferred from the Federal Hospital Insurance Trust 
Fund (established under section 1817 of the Social Secu-
rity Act) and from the Federal Supplementary Medical In-
surance Trust Fund (established under section 1841 of 
such Act), and from the Medicare Prescription Drug Ac-
count within such Trust Fund, in proportion (as estimated 
by the Secretary) to the total expenditures during such 
fiscal year that are made under title XVIIII of such Act 
from the respective trust fund or account. 
‘‘(c) FAIR SHARE AMOUNT.— 
‘‘(1) IN GENERAL.—The Secretary of Health 
and Human Services shall compute for each fiscal 
year (beginning with fiscal year 2008) a fair share 
amount under this subsection that is an amount 
that, when applied under this section and subchapter 
B of chapter 34 of the Internal Revenue Code of 
1986, will result in revenues to the Trust Fund (tak-
ing into account any outstanding balance in the 
Trust Fund) for the fiscal year as follows: 
‘‘(A) for fiscal year 2008, $100,000,000; 
‘‘(B) for fiscal year 2009, $200,000,000; 
and 
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157 
‘‘(C) for each of fiscal years 2010 through 
2012, $900,000,000. 
‘‘(2) LIMITATION ON MEDICARE FUNDING.—In 
no case shall the amount transferred under sub-
section 
(b)(2) 
for 
any 
fiscal 
year 
exceed 
$200,000,000. 
‘‘(d) EXPENDITURES FROM FUND.—Amounts in the 
Trust Fund are available to the Secretary of Health and 
Human Services for carrying out section 1013 of the 
Medicare Prescription Drug, Improvement, and Mod-
ernization Act of 2003. 
‘‘(e) NET REVENUES.—For purposes of this section, 
the term ‘net revenues’ means the amount estimated by 
the Secretary based on the excess of— 
‘‘(1) the fees received in the Treasury under 
subchapter B of chapter 34, over 
‘‘(2) the decrease in the tax imposed by chapter 
1 resulting from the fees imposed by such sub-
chapter.’’. 
(2) CLERICAL AMENDMENT.—The table of sec-
tions for such subchapter A is amended by adding 
at the end thereof the following new item: 
‘‘Sec. 9511. Health Care Comparative Effectiveness Research Trust Fund.’’. 
(b) FINANCING FOR FUND FROM FEES ON INSURED 
AND SELF-INSURED HEALTH PLANS.— 
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158 
(1) GENERAL RULE.—Chapter 34 of the Inter-
nal Revenue Code of 1986 is amended by adding at 
the end the following new subchapter: 
‘‘Subchapter B—Insured Health Plans 
‘‘Sec. 4375. Health insurance. 
‘‘Sec. 4376. Definitions and special rules. 
‘‘SEC. 4375. HEALTH INSURANCE. 
‘‘(a) IMPOSITION OF FEE.—There is hereby imposed 
on each specified health insurance policy for each policy 
year a fee equal to the fair share amount determined 
under section 9511(c)(1) multiplied by the average num-
ber of lives covered under the policy. 
‘‘(b) LIABILITY FOR FEE.—The fee imposed by sub-
section (a) shall be paid by the issuer of the policy. 
‘‘(c) SPECIFIED HEALTH INSURANCE POLICY.—For 
purposes of this section— 
‘‘(1) IN GENERAL.—Except as otherwise pro-
vided in this section, the term ‘specified health in-
surance policy’ means any accident or health insur-
ance policy issued with respect to individuals resid-
ing in the United States. 
‘‘(2) EXEMPTION OF CERTAIN POLICIES.—The 
term ‘specified health insurance policy’ does not in-
clude any insurance policy if substantially all of the 
coverage provided under such policy relates to— 
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159 
‘‘(A) liabilities incurred under workers’ 
compensation laws, 
‘‘(B) tort liabilities, 
‘‘(C) liabilities relating to ownership or use 
of property, 
‘‘(D) credit insurance, 
‘‘(E) medicare supplemental coverage, or 
‘‘(F) such other similar liabilities as the 
Secretary may specify by regulations. 
‘‘(3) TREATMENT OF PREPAID HEALTH COV-
ERAGE ARRANGEMENTS.— 
‘‘(A) IN GENERAL.—In the case of any ar-
rangement described in subparagraph (B)— 
‘‘(i) such arrangement shall be treated 
as a specified health insurance policy, and 
‘‘(ii) the person referred to in such 
subparagraph shall be treated as the 
issuer. 
‘‘(B) DESCRIPTION OF ARRANGEMENTS.— 
An arrangement is described in this subpara-
graph if under such arrangement fixed pay-
ments or premiums are received as consider-
ation for any person’s agreement to provide or 
arrange for the provision of accident or health 
coverage to residents of the United States, re-
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