127 
subsection (o) as subsection (p) and by inserting 
after subsection (n) the following new subsection: 
‘‘(o) QUALIFIED HEALTH CARE FRINGE.—For pur-
poses of this section, the term ‘qualified health care fringe’ 
means— 
‘‘(1) any wellness program described in section 
131 of the Healthy Americans Act, and 
‘‘(2) any on-site first aid coverage for employ-
ees.’’. 
(2) NONDISCRIMINATORY
TREATMENT.—Sec-
tion 132(j)(1) of such Code (relating to exclusions 
under subsection (a)(1) and (2) apply to highly com-
pensated employees only if no discrimination) is 
amended— 
(A) by striking ‘‘Paragraphs (1) and (2) of 
subsection (a)’’ and inserting ‘‘Paragraphs (1), 
(2), and (9) of subsection (a)’’, and 
(B) by striking ‘‘SUBSECTION (a)(1) AND’’ 
in the heading and inserting ‘‘SUBSECTIONS 
(a)(1), (2), AND’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to calendar years beginning at 
least 4 years after the date of the enactment of the 
Healthy Americans Act. 
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SEC. 663. LIMITED EMPLOYER DEDUCTION FOR EMPLOYER 
SHARED RESPONSIBILITY PAYMENTS, HIS-
TORIC RETIREE HEALTH CONTRIBUTIONS, 
AND OTHER HEALTH CARE EXPENSES. 
(a) IN GENERAL.—Subsection (l) of section 162 of 
the Internal Revenue Code of 1986 (relating to trade or 
business expenses) is amended to read as follows: 
‘‘(l) 
LIMITATION
ON
DEDUCTIBLE
EMPLOYER 
HEALTH CARE EXPENDITURES.—No deduction shall be 
allowed under this chapter for any employer contribution 
to an accident or health plan other than— 
‘‘(1) any shared responsibility payment made 
under section 3411, 
‘‘(2) any accident or health plan coverage for 
individuals who are former employees before the first 
calendar year beginning 4 years after the date of the 
enactment of the Healthy Americans Act, 
‘‘(3) any accident or health plan in effect on 
January 1 of the first calendar year beginning 4 
years after the date of the enactment of the Healthy 
Americans Act with respect to coverage for qualified 
collective bargaining employees during a transition 
period described in section 3432, 
‘‘(4) any accident or health plan which qualifies 
as a wellness program described in section 131 of 
such Act, 
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129 
‘‘(5) any accident or health plan which con-
stitutes on-site first aid coverage for employees, and 
‘‘(6) any accident or health plan which is a 
qualified long-term care insurance contract.’’. 
(b) CONFORMING AMENDMENT.—Section 162 of the 
Internal Revenue Code of 1986 is amended by striking 
subsection (n). 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to calendar years beginning at 
least 4 years after the date of the enactment of the 
Healthy Americans Act. 
SEC. 664. REFUNDABLE CREDIT FOR INDIVIDUAL SHARED 
RESPONSIBILITY PAYMENTS. 
(a) IN GENERAL.—Subpart C of part IV of sub-
chapter A of chapter 1 of the Internal Revenue Code of 
1986 is amended by inserting after section 36A the fol-
lowing new section: 
‘‘SEC. 36B. REFUNDABLE CREDIT FOR INDIVIDUAL SHARED 
RESPONSIBILITY PAYMENTS. 
‘‘(a) IN GENERAL.—In the case of an individual, if 
the taxpayer has gross income for the taxable year exceed-
ing 100 percent of the poverty line (adjusted for the size 
of the family involved) for the calendar year in which such 
taxable year begins and is enrolled in a HAPI plan under 
the Healthy Americans Act, there shall be allowed as a 
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130 
credit against the tax imposed by this chapter an amount 
equal to the applicable fraction times, in the case of— 
‘‘(1) coverage of an individual, $1,975, 
‘‘(2) coverage of a married couple or domestic 
partnership (as determined by a State) without de-
pendent children, $3,950, 
‘‘(3) coverage of an unmarried individual with 
1 or more dependent children, $3,660, plus $600 for 
each dependent child, and 
‘‘(4) coverage of a married couple or domestic 
partnership (as determined by a State) with 1 or 
more dependent children, $4,860, plus $600 for each 
dependent child. 
‘‘(b) APPLICABLE FRACTION.—For purposes of sub-
section (a), the applicable fraction is the fraction (not to 
exceed 1)— 
‘‘(1) the numerator of which is the gross in-
come of the taxpayer for the taxable year expressed 
as a percentage of the poverty line (adjusted for the 
size of the family involved) minus such poverty line 
for the calendar year in which such taxable year be-
gins, and 
‘‘(2) the denominator of which is 400 percent of 
the poverty line (adjusted for the size of the family 
involved) minus such poverty line. 
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131 
‘‘(c) PHASEOUT OF CREDIT AMOUNT.— 
‘‘(1) IN GENERAL.—The amount otherwise de-
termined under subsection (a) for any taxable year 
shall be reduced by the amount determined under 
paragraph (2). 
‘‘(2) AMOUNT
OF
REDUCTION.—The amount 
determined under this paragraph shall be the 
amount which bears the same ratio to the amount 
determined under subsection (a) as— 
‘‘(A) the excess of the taxpayer’s modified 
adjusted gross income for such taxable year, 
over $62,500 (twice such amount in the case of 
a joint return), bears to 
‘‘(B) $62,500 (twice such amount in the 
case of a joint return). 
Any amount determined under this paragraph which 
is not a multiple of $50 shall be rounded to the next 
lowest $50. 
‘‘(d) INFLATION ADJUSTMENT.—In the case of any 
taxable year beginning in a calendar year after 2009, each 
dollar amount contained in subsection (a) and subpara-
graphs (A) and (B) of subsection (c)(2) shall be increased 
by an amount equal to— 
‘‘(1) such dollar amount, multiplied by 
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132 
‘‘(2) the cost-of-living adjustment determined 
under section 1(f)(3) for the calendar year in which 
the taxable year begins, determined by substituting 
‘calendar year 2009’ for ‘calendar year 1992’ in sub-
paragraph (B) thereof. 
Any increase in a dollar amount contained in subsection 
(a) that is determined under the preceding sentence shall 
be rounded to the nearest multiple of $5 and any increase 
in a dollar amount contained in subparagraph (A) or (B) 
of subsection 9c)(2) that is determined under the pre-
ceding sentence shall be rounded to the nearest multiple 
of $50. 
‘‘(e) DETERMINATION
OF
MODIFIED
ADJUSTED 
GROSS INCOME.— 
‘‘(1) IN GENERAL.—For purposes of this sec-
tion, the term ‘modified adjusted gross income’ 
means adjusted gross income— 
‘‘(A) determined without regard to this 
section and sections 86, 135, 137, 199, 221, 
222, 911, 931, and 933, and 
‘‘(B) increased by— 
‘‘(i) the amount of interest received or 
accrued during the taxable year which is 
exempt from tax under this title, and 
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133 
‘‘(ii) the amount of any social security 
benefits (as defined in section 86(d)) re-
ceived or accrued during the taxable year. 
‘‘(2) POVERTY
LINE.—For purposes of this 
paragraph, the term ‘poverty line’ has the meaning 
given such term in section 673(2) of the Community 
Health Services Block Grant Act (42 U.S.C. 
9902(2)), including any revision required by such 
section.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Paragraph (2) of section 1324(b) of title 
31, United States Code, is amended by inserting 
‘‘36B,’’ after ‘‘36A,’’. 
(2) The table of sections for subpart C of part 
IV of subchapter A of chapter 1 of the Internal Rev-
enue Code of 1986 is amended by inserting after the 
item relating to section 36A the following new item: 
‘‘Sec. 36B. Refundable credit for individual shared responsibility payments.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to payments made in calendar 
years beginning at least 4 years after the date of the en-
actment of this Act. 
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134 
SEC. 665. MODIFICATION OF OTHER TAX INCENTIVES TO 
COMPLEMENT HEALTHY AMERICANS PRO-
GRAM. 
(a) TERMINATION OF CREDIT FOR HEALTH INSUR-
ANCE COSTS OF ELIGIBLE INDIVIDUALS.—Section 35 of 
the Internal Revenue Code of 1986 (relating to health in-
surance costs of eligible individuals) is amended by adding 
at the end the following new subsection: 
‘‘(h) TERMINATION.—This section shall not apply to 
payments made in any calendar year beginning at least 
4 years after the date of the enactment of the Healthy 
Americans Act.’’. 
(b) TERMINATION OF HEALTH CARE EXPENSE RE-
IMBURSEMENT UNDER CAFETERIA PLANS.— 
(1) IN GENERAL.—Section 125 of the Internal 
Revenue Code of 1986 (relating to cafeteria plans) 
is amended by redesignating subsection (h) as sub-
section (i) and by inserting after subsection (g) the 
following new subsection: 
‘‘(h) TERMINATION.—This section shall not apply to 
health benefits coverage in any calendar year beginning 
at least 4 years after the date of the enactment of the 
Healthy Americans Act.’’. 
(2) LONG-TERM CARE ALLOWED UNDER CAFE-
TERIA PLANS.— 
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135 
(A) IN GENERAL.—Section 125(f) of such 
Code (defining qualified benefits) is amended by 
striking the last sentence. 
(B) EFFECTIVE
DATE.—The amendment 
made by this paragraph shall apply to contracts 
issued with respect to any calendar year begin-
ning at least 4 years after the date of the en-
actment of this Act. 
(c) TERMINATION
OF ARCHER MSA CONTRIBU-
TIONS.—Section 220 of the Internal Revenue Code of 
1986 (relating to Archer MSAs) is amended— 
(1) by inserting ‘‘and made before the first cal-
endar year beginning 4 years after the date of the 
enactment of the Healthy Americans Act’’ after ‘‘in 
cash’’ in subsection (d)(1)(A)(i), and 
(2) by adding at the end the following new sub-
section: 
‘‘(k) TERMINATION.—This section shall not apply to 
contributions made in any calendar year beginning at least 
4 years after the date of the enactment of the Healthy 
Americans Act.’’. 
(d) HEALTH SAVINGS ACCOUNTS ALLOWED IN CON-
JUNCTION WITH HIGH DEDUCTIBLE HAPI PLANS.— 
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136 
(1) IN GENERAL.—Section 223 of the Internal 
Revenue Code of 1986 (relating to health savings ac-
counts) is amended— 
(A) by inserting ‘‘qualified’’ before ‘‘high 
deductible health plan’’ each place it appears in 
the text (other than subsection (c)(2)(A)), 
(B) by striking ‘‘The term ‘high deductible 
health plan’ means a health plan’’ in subsection 
(c)(2)(A) and inserting ‘‘The term ‘qualified 
high deductible health plan’ means a HAPI 
plan under the Healthy Americans Act’’, 
(C) by striking subparagraphs (B) and (C) 
of subsection (c)(2) and by re-designating sub-
paragraph (D) of subsection (c)(2) as subpara-
graph (B), and 
(D) by striking ‘‘HIGH’’ in the heading for 
paragraph (2) of subsection (c) and inserting 
‘‘QUALIFIED HIGH’’. 
(2) EFFECTIVE DATE.—The amendments made 
by this subsection shall apply to payments made in 
calendar years beginning at least 4 years after the 
date of the enactment of this Act. 
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137 
SEC. 666. TERMINATION OF CERTAIN EMPLOYER INCEN-
TIVES WHEN REPLACED BY LOWER HEALTH 
CARE COSTS. 
(a) IN GENERAL.—Subchapter C of chapter 90 of the 
Internal Revenue Code of 1986 (relating to provisions af-
fecting more than one subtitle) is amended by adding at 
the end the following new section: 
‘‘SEC. 7875. TERMINATION OF CERTAIN PROVISIONS. 
‘‘The following provisions shall not apply to taxable 
years beginning (or transactions in the case of sections 
referred to in paragraph (3)) in any calendar year begin-
ning at least 4 years after the date of the enactment of 
the Healthy Americans Act: 
‘‘(1) Section 199 (relating to income attrib-
utable to domestic production activities). 
‘‘(2) Section 501(c)(9) (relating to tax-exempt 
status of voluntary employees’ beneficiary associa-
tions). 
‘‘(3) Sections 861(a)(6), 862(a)(6), 863(b)(2), 
863(b)(3), and 865(b) (relating to inventory prop-
erty sales source rule exception).’’. 
(b) DEFERRAL OF ACTIVE INCOME OF CONTROLLED 
FOREIGN CORPORATIONS.—Section 952 of the Internal 
Revenue Code of 1986 (relating to subpart F income de-
fined) is amended by adding at the end the following new 
subsection: 
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138 
‘‘(e) SPECIAL APPLICATION OF SUBPART.— 
‘‘(1) IN GENERAL.—For taxable years begin-
ning in any calendar year beginning at least 4 years 
after the date of the enactment of the Healthy 
Americans Act, notwithstanding any other provision 
of this subpart, the term ‘subpart F income’ means, 
in the case of any controlled foreign corporation, the 
income of such corporation derived from any foreign 
country. 
‘‘(2) APPLICABLE RULES.—Rules similar to the 
rules under the last sentence of subsection (a) and 
subsection (d) shall apply to this subsection.’’. 
(c) CONFORMING AMENDMENT.—The table of sec-
tions for subchapter C of chapter 90 of the Internal Rev-
enue Code of 1986 is amended by adding at the end the 
following new item: 
‘‘Sec. 7875. Termination of certain provisions.’’. 
PART 2—CLARIFICATION OF ERISA TREATMENT; 
TERMINATION OF COVERAGE UNDER OTHER 
GOVERNMENTAL PROGRAMS AND TRANSI-
TION RULES FOR MEDICAID AND CHIP 
SEC. 671. CLARIFICATION OF ERISA APPLICABILITY TO EM-
PLOYER-SPONSORED HAPI PLANS. 
(a) ERISA.—Section 3(1) of Employee Retirement 
Income Security Act of 1974 (29 U.S.C. 1002(1)) is 
amended by adding at the end the following new sentence: 
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139 
‘‘Such terms include the provision of medical, surgical, or 
hospital care or benefits through a HAPI plan described 
under section 103 of the Healthy Americans Act.’’. 
(b) INTERNAL REVENUE CODE OF 1986.—Section 
5000 of the Internal Revenue Code of 1986 (relating to 
certain group health plans) is amended by adding at the 
end the following new subsection: 
‘‘(e) HAPI PLANS.—For purposes of this section, the 
terms ‘group health plan’ and ‘large group health plan’ 
include any HAPI plan described under section 103 of the 
Healthy Americans Act.’’. 
(c) 
PUBLIC
HEALTH
SERVICE
ACT.—Section 
2791(b)(5) of the Public Health Service Act (42 U.S.C. 
300gg–91(b)(5)) is amended by adding at the end the fol-
lowing new sentence: ‘‘Such term includes health insur-
ance coverage offered to individuals through a HAPI plan 
described under section 103 of the Healthy Americans 
Act.’’. 
SEC. 672. FEDERAL EMPLOYEES HEALTH BENEFITS PLAN. 
(a) IN GENERAL.—Chapter 89 of title 5, United 
States Code, is amended by adding at the end the fol-
lowing new section: 
‘‘§ 8915. Termination 
‘‘No contract shall be entered into under this chapter 
or chapters 89A and 89B with respect to any coverage 
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140 
period occurring in any calendar year beginning at least 
4 years after the date of the enactment of the Healthy 
Americans Act.’’. 
(b) CONFORMING AMENDMENT.—The table of sec-
tions for such chapter 89 is amended by adding at the 
end the following new item: 
‘‘8915. Termination.’’. 
SEC. 673. MEDICAID AND SCHIP. 
(a) IN GENERAL.—Title XIX of the Social Security 
Act, as amended by section 311, is amended by adding 
at the end the following new section: 
‘‘TRANSITION
TO
COVERAGE
UNDER
HAPI
PLANS; RE-
QUIREMENT
TO
PROVIDE
SUPPLEMENTAL
COV-
ERAGE; TERMINATION OF UNNECESSARY PROVISIONS 
‘‘SEC. 1944. (a) TRANSITION AND SUPPLEMENTAL 
COVERAGE REQUIREMENTS.—The Secretary shall provide 
technical assistance to States and health insurance issuers 
of HAPI plans to ensure that individuals receiving medical 
assistance under State Medicaid plans under this title or 
child health assistance under child health plans under title 
XXI are— 
‘‘(1) informed of— 
‘‘(A) the guarantee of private coverage for 
essential services for all Americans established 
by the Healthy Americans Act; and 
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141 
‘‘(B) each individual’s personal responsi-
bility— 
‘‘(i) for health care prevention; 
‘‘(ii) to enroll (or to be enrolled on 
their behalf) in a HAPI plan through the 
applicable State HHA during an open en-
rollment period; and 
‘‘(iii) to submit necessary documenta-
tion to their State HHA so that the HHA 
may determine the individual’s eligibility 
for premium and personal responsibility 
contribution subsidies; 
‘‘(2) provided with appropriate assistance in 
transitioning from receiving medical assistance 
under State Medicaid plans or child health assist-
ance under child health plans for their primary 
health coverage to obtaining such coverage through 
enrollment in HAPI plans in a manner that ensures 
continuation of coverage for such individuals; and 
‘‘(3) notwithstanding any other provision of this 
title, after December 31 of the last calendar year 
ending before the first calendar year in which cov-
erage under a HAPI plan begins in accordance with 
the Healthy Americans Act, provided with medical 
assistance that consists of supplemental coverage 
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142 
that meets the requirements of sections 202 and 301 
of such Act. 
‘‘(b) MAINTENANCE
OF
MEDICARE
COST-SHAR-
ING.—For each month beginning after the last month of 
the last calendar year ending before the first calendar year 
in which coverage under a HAPI plan begins in accord-
ance with the Healthy Americans Act— 
‘‘(1) a State shall continue to provide medical 
assistance for Medicare cost-sharing to individuals 
described in section 1902(a)(10)(E) as if the 
Healthy Americans Act had not been enacted; and 
‘‘(2) the Secretary shall continue to reimburse 
the State for the provision of such medical assist-
ance. 
‘‘(c) CONTINUED SUPPORT
FOR DSH EXPENDI-
TURES.— 
‘‘(1) IN GENERAL.—Notwithstanding any other 
provision of this title, with respect to each fiscal year 
that begins after the first calendar year in which 
coverage under a HAPI plan begins in accordance 
with the Healthy Americans Act, the DSH allotment 
for each State otherwise applicable under section 
1923(f) for that fiscal year shall be reduced by 90 
percent and no payment shall be made under section 
1903(a) to a State with respect to any payment ad-
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143 
justment made under section 1923 for hospitals in 
the State for quarters in the fiscal year in excess of 
the reduced DSH allotment for the State applicable 
for such year. 
‘‘(2) SPECIAL RULE FOR LAST 3 QUARTERS OF 
FIRST FISCAL YEAR IN WHICH COVERAGE UNDER A 
HAPI PLAN BEGINS.—With respect to the first fiscal 
year in which coverage under a HAPI plan begins 
in accordance with the Healthy Americans Act, the 
Secretary shall reduce the DSH allotment for each 
State that is otherwise applicable under section 
1923(f) for that fiscal year so that each such DSH 
allotment reflects a 90 percent reduction in the allot-
ment for the second, third, and fourth quarters of 
that fiscal year. 
‘‘(d) TERMINATION OF ALL FEDERAL PAYMENTS 
UNDER THIS TITLE OTHER THAN FOR MEDICARE COST- 
SHARING OR SUPPLEMENTAL MEDICAL ASSISTANCE.— 
Notwithstanding any other provision of this title: 
‘‘(1) no individual other than an individual to 
which section 202 or 301 of the Healthy Americans 
Act applies is entitled to medical assistance under a 
State plan approved under this title for any item or 
service furnished after December 31 of the last cal-
endar year ending before the first calendar year in 
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144 
which coverage under a HAPI plan begins in accord-
ance with such Act; 
‘‘(2) no payment shall be made to a State 
under section 1903(a) for any item or service fur-
nished after that date or for any other sums ex-
pended by a State for which a payment would have 
been made under such section, other than for the 
Federal medical assistance percentage of the total 
amount expended by a State for each fiscal year 
quarter beginning after that date for providing— 
‘‘(A) medical assistance for the mainte-
nance of Medicare cost-sharing in accordance 
with subsection (b); 
‘‘(B) medical assistance for individuals who 
are eligible for supplemental medical assistance 
under this title after such date in accordance 
with section 202 or 301 of the Healthy Ameri-
cans Act; and 
‘‘(C) payment adjustments under section 
1923 for hospitals in the State that do not ex-
ceed the reduced DSH allotment for the State 
determined under subsection (c).’’. 
(b) APPLICATION TO SCHIP.— 
(1) APPLICATION
OF
TRANSITION
REQUIRE-
MENTS.—Section 2107(e)(1) of the Social Security 
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145 
Act (42 U.S.C. 1397gg(e)(1)) is amended by adding 
at the end the following: 
‘‘(M) Section 1944(a) (relating to transi-
tion to coverage under HAPI plans and, in the 
case of paragraph (3) of such section, the re-
quirement to provide supplemental medical as-
sistance for targeted low-income children who 
are provided child health assistance as optional 
targeted 
low-income 
children 
under 
title 
XIX).’’. 
(2) TERMINATION.—Title XXI of the Social Se-
curity Act is amended by adding at the end the fol-
lowing new section: 
‘‘TERMINATION 
‘‘SEC. 2114. Notwithstanding any other provision of 
this title, no payment shall be made to a State under sec-
tion 2105(a) with respect to child health assistance for 
any item or service furnished after December 31 of the 
last calendar year ending before the first calendar year 
in which coverage under a HAPI plan begins in accord-
ance with the Healthy Americans Act.’’. 
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146 
TITLE 
VII—PURCHASING 
HEALTH 
SERVICES 
AND 
PRODUCTS THAT ARE MOST 
EFFECTIVE 
SEC. 701. ONE TIME DISALLOWANCE OF DEDUCTION FOR 
ADVERTISING AND PROMOTIONAL EXPENSES 
FOR 
CERTAIN 
PRESCRIPTION 
PHARMA-
CEUTICALS. 
(a) IN GENERAL.—Part IX of subchapter B of chap-
ter 1 of subtitle A of the Internal Revenue Code of 1986 
(relating to items not deductible) is amended by adding 
at the end the following new section: 
‘‘SEC. 280I. ONE TIME DISALLOWANCE OF DEDUCTION FOR 
CERTAIN PRESCRIPTION PHARMACEUTICALS 
ADVERTISING 
AND 
PROMOTIONAL 
EX-
PENSES. 
‘‘(a) IN GENERAL.—No deduction shall be allowed 
under this chapter for expenses relating to advertising or 
promoting the sale and use of prescription pharma-
ceuticals other than drugs for rare diseases or conditions 
(within the meaning of section 45C) for any taxable year 
which includes any portion of— 
‘‘(1) the 3-year period which begins on the date 
of a new drug application approval with respect to 
such a pharmaceutical, unless the manufacturer of 
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147 
such pharmaceutical is subject to a comparison ef-
fectiveness study, including over-the-counter medica-
tion (if appropriate), or 
‘‘(2) the 1-year period which ends with the 
availability of a generic drug substitute, unless such 
advertising or promotion includes a statement that 
a lower cost alternative may soon be available and 
includes the chemical name of such alternative. 
‘‘(b) ADVERTISING OR PROMOTING.—For purposes of 
this section, the term ‘advertising or promoting’ includes 
direct-to-consumer advertising and any activity designed 
to promote the use of a prescription pharmaceutical di-
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. 
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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: 
‘‘(w)(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 
‘‘(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 
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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; 
‘‘(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: 
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‘‘(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. 
‘‘(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 
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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 
‘‘(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. 
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(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. 
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 WEB SITE.—Not later 
than 1 year after the date of enactment of the Healthy 
Americans Act, the Agency shall establish an Internet 
Web site— 
‘‘(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 
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‘‘(B) clearly identifies the funding source 
for the research. 
‘‘(b) PILOT PROGRAM.— 
‘‘(1) ESTABLISHMENT.—Using the information 
about evidence-informed best practices from the Web 
site 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 
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; 
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‘‘(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-
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 Web site 
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 Web site with respect to the 
quality of care of a health care provider, the Secretary 
shall— 
(1) on the date of establishment of the Web 
site, use information on the performance of pro-
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155 
viders in quality initiatives under the Medicare pro-
gram, including demonstration projects, reporting 
initiatives, and pay for performance efforts; and 
(2) not later than 3 years after the date of es-
tablishment of the Web site, in addition to the infor-
mation used under paragraph (1), use quality of 
care standards developed in consultation with, and 
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. 
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156 
TITLE VIII—ENHANCED HEALTH 
CARE VALUE 
SEC. 801. 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 
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: 
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‘‘(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 
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.’’; 
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(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; 
(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 this subpara-
graph, the stakeholder group consulted for 
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purposes of subparagraph (C)(1) shall be 
known as the Comparative Effectiveness 
Advisory Board. Any reference in a law, 
map, regulation, document, paper, or other 
record of the United States to such stake-
holder group shall be deemed to be a ref-
erence to 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 
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member shall be appointed for a term of 2 
years. The members appointed for the first 
term following the date of the enactment 
of this subparagraph shall be appointed 
not later than 90 days after such date of 
enactment. Any member serving on the 
Advisory Board as of such date of enact-
ment 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 this sub-
paragraph, the Comparative Effectiveness Advi-
sory Board shall have the following authorities: 
‘‘(i) To provide input on research pri-
orities. 
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‘‘(ii) To recommend how to organize 
research funded under this section taking 
into consideration the full range of appro-
priate methodologies, including randomized 
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 this subparagraph, regarding the 
establishment 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. 
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‘‘(vi) To ensure that such priorities 
are in accordance with the principles de-
scribed in subparagraph (F). 
‘‘(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. 
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