serum, and other biological specimens (such as 
ascites and pleural fluids). 
(E) Other areas identified by the Director, 
in consultation with the research community. 
(3) 
COLLABORATION.—Any 
center 
funded 
under paragraph (1) shall demonstrate their intent 
to collaborate with current National Cancer Institute 
funded, sponsored, or funded and sponsored initia-
tives regarding risk stratification, early detection, 
and screening of cancer, including but not limited to 
the early detection research networks, the Cancer 
Genomic Atlas, and therapeutic biomarker initia-
tives, where applicable. 
(4) AVAILABILITY
OF
BANKED
SPECIMENS.— 
The Director of the Institute shall make available 
for research conducted under this section banked 
serum and tissue specimens from clinical research 
regarding these cancers that was funded by the De-
partment of Health and Human Services. 
(5) REPORT.—Not later than the end of fiscal 
year 2011, and annually thereafter, the Director of 
the Institute shall submit a report to the Congress 
on the cooperative agreements entered into and the 
grants made under this subsection, the progress of 
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these grants, and recommendations for any program 
improvements that would speed discovery. 
(6) BIOMARKER CLINICAL TRIAL COMMITTEE.— 
The Director of the Institute shall establish an Bio-
marker Clinical Trial Committee (in this section re-
ferred to as the ‘‘Committee’’), for each cancer with 
biomarker centers of excellence, to assist the Direc-
tor to design and implement one or more national 
clinical trial, in accordance with this subsection, to 
determine the utility of using biomarkers validated 
pursuant to the research conducted under this sub-
section for risk stratification for, and early detection 
and screening of, cancers with a five-year survival 
rate of less than 50 percent. 
(7) AUTHORIZATION OF APPROPRIATIONS.—For 
the purpose of carrying out this subsection, there 
are authorized to be appropriated $25,000,000 for 
each of the fiscal years 2011 through 2013, and 
such sums as may be necessary for each of the fiscal 
years 2014 through 2020. If for two consecutive 
years funds are not appropriated to carry out this 
subsection, this subsection will automatically sunset. 
Such authorization of appropriations is in addition 
to any other authorization of appropriations that is 
available for such purpose. 
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(f) SENSE OF THE HOUSE OF REPRESENTATIVES.— 
It is the sense of the House of Representatives that the 
Commissioner of Food and Drugs and the Director of the 
National Cancer Institute should continue to place high 
priority upon the identification and use of biomarkers to— 
(1) determine the role of genetic polymorphisms 
on drug activity and toxicity; 
(2) establish effective strategies for selecting 
patients for treatment with specific drugs; and 
(3) identify early biomarkers of clinical benefit. 
(g) DEFINITION.—In this section, the term ‘‘bio-
marker’’ means any characteristic that can be objectively 
measured and evaluated as an indicator of normal biologic 
processes, pathogenic processes, or pharmacological re-
sponses to therapeutic interventions. 
SEC. 8. EXTENDING COVERAGE UNDER MEDICAID OF 
COUNSELING AND PHARMACOTHERAPY FOR 
CESSATION OF TOBACCO USE. 
(a) SERVICES DESCRIBED.—Section 1905 of the So-
cial Security Act (42 U.S.C. 1396d) is amended— 
(1) in subsection (a)(4)(D), as inserted by sec-
tion 4107(a)(1)(B) of the Patient Protection and Af-
fordable Care Act (Public Law 111–148), by strik-
ing ‘‘by pregnant women’’; and 
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(2) in subsection (bb), as added by section 
4107(a)(2) of the Patient Protection and Affordable 
Care Act (Public Law 111–148)— 
(A) in paragraph (1)— 
(i) by striking ‘‘the term ‘counseling 
and pharmacotherapy for cessation of to-
bacco use by pregnant women’ ’’ and in-
serting 
‘‘the 
term 
‘counseling 
and 
pharmacotherapy for cessation of tobacco 
use’ ’’; and 
(ii) by striking ‘‘by pregnant women 
who use tobacco products’’ and inserting 
‘‘by individuals who use tobacco products’’; 
and 
(B) in paragraph (2)— 
(i) in subparagraph (A), by striking 
‘‘with respect to pregnant women’’; and 
(ii) in subparagraph (B), by striking 
‘‘by pregnant women’’. 
(b) DROPPING EXCEPTION FROM MEDICAID PRE-
SCRIPTION DRUG COVERAGE FOR TOBACCO CESSATION 
MEDICATIONS.—Section 1927(d)(2)(F) of the Social Se-
curity Act (42 U.S.C. 1396r–8(d)(2)(F)), as amended by 
section 4107(b) of the Patient Protection and Affordable 
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Care Act (Public Law 111–148), is further amended by 
striking ‘‘in the case of pregnant women’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect 1 year after the date of enact-
ment of this Act and apply to medical assistance provided 
under a State Medicaid program on or after such date. 
SEC. 9. COMPREHENSIVE CANCER CARE AND COVERAGE 
UNDER MEDICARE. 
(a) COVERAGE
OF ROUTINE COSTS ASSOCIATED 
WITH CLINICAL TRIALS UNDER MEDICARE.— 
(1) COVERAGE UNDER PART A.—Section 1814 
of the Social Security Act (42 U.S.C. 1395f) is 
amended by adding at the end the following new 
subsection: 
‘‘(m) COVERAGE OF ROUTINE COSTS ASSOCIATED 
WITH CLINICAL TRIALS.—The Secretary shall not exclude 
from payment for items and services provided under a 
clinical trial payment for coverage of routine costs of care 
(as defined by the Secretary) furnished to an individual 
entitled to benefits under this part who participates in 
such a trial to the extent the Secretary provides payment 
for such costs as of the date of enactment of this sub-
section.’’. 
(2) 
COVERAGE
UNDER
PART
B.—Section 
1833(w) of the Social Security Act (42 U.S.C. 
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