(b) OPTIONAL MEDICAID COVERAGE OF CERTAIN 
PERSONS SCREENED AND FOUND TO HAVE COLORECTAL 
CANCER.— 
(1) COVERAGE
AS
OPTIONAL
CATEGORICALLY 
NEEDY GROUP.— 
(A) 
IN
GENERAL.—Section 
1902(a)(10)(A)(ii) of the Social Security Act 
(42 U.S.C. 1396a(a)(10)(A)(ii)), as amended by 
section 2402(d)(1) of the Patient Protection 
and Affordable Care Act (Public Law 111–148) 
is further amended— 
(i) in subclause (XXI), by striking 
‘‘or’’ at the end; 
(ii) in subclause (XXII), by adding 
‘‘or’’ at the end; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(XXIII) who are described in 
subsection (kk) (relating to certain 
persons screened and found to need 
treatment from complications from 
screening or have colorectal cancer);’’. 
(B) GROUP DESCRIBED.—Section 1902 of 
the Social Security Act (42 U.S.C. 1396a), as 
amended by section 211(a)(1)(A)(ii) of Public 
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Law 111–3, section 5006(b)(1) of division B of 
Public Law 111–5, and section 1202 of the Pa-
tient Protection and Affordable Care Act (Pub-
lic Law 111–148), is further amended by add-
ing at the end the following: 
‘‘(kk) Individuals described in this subsection are in-
dividuals who— 
‘‘(1) 
are 
not 
described 
in 
subsection 
(a)(10)(A)(i); 
‘‘(2) have not attained age 65; 
‘‘(3) have been screened for colorectal cancer 
and need treatment for complications due to screen-
ing or colorectal cancer; and 
‘‘(4) are not otherwise covered under creditable 
coverage, as defined in section 2704(c) of the Public 
Health Service Act.’’. 
(C) LIMITATION
ON
BENEFITS.—Section 
1902(a)(10) of the Social Security Act (42 
U.S.C. 1396a(a)(10)) is amended in the matter 
following subparagraph (G)— 
(i) by striking ‘‘(XV)’’ and inserting 
‘‘, (XV)’’; 
(ii) by striking ‘‘and (XVI) the med-
ical assistance’’ and inserting ‘‘, (XVI) the 
medical assistance’’; 
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(iii) by striking ‘‘and (XVI) if an indi-
vidual’’ and inserting ‘‘, (XVII) if an indi-
vidual’’; and 
(iv) by inserting ‘‘, and (XVIII) the 
medical assistance made available to an in-
dividual described in subsection (kk) who 
is eligible for medical assistance only be-
cause of subparagraph (A)(10)(ii)(XXIII) 
shall be limited to medical assistance pro-
vided during the period in which such an 
individual requires treatment for complica-
tions due to screening or colorectal cancer’’ 
before the semicolon. 
(D) CONFORMING AMENDMENTS.—Section 
1905(a) of the Social Security Act (42 U.S.C. 
1396d(a)), 
as 
amended 
by 
section 
2402(d)(2)(B) of the Patient Protection and 
Affordable Care Act (Public Law 111–148) is 
further amended in the matter preceding para-
graph (1)— 
(i) in clause (xvi), by striking ‘‘or’’ at 
the end; 
(ii) in clause (xvii), by adding ‘‘or’’ at 
the end; and 
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(iii) by inserting after clause (xvii) the 
following: 
‘‘(xviii) individuals described in sec-
tion 1902(kk),’’. 
(2) PRESUMPTIVE ELIGIBILITY.— 
(A) IN GENERAL.—Title XIX of the Social 
Security Act (42 U.S.C. 1396 et seq.) is 
amended by inserting after section 1920C, as 
inserted by section 2303(b) of the Patient Pro-
tection and Affordable Care Act (Public Law 
111–148), the following: 
‘‘OPTIONAL APPLICATION OF PRESUMPTIVE ELIGIBILITY 
PROVISIONS
FOR
CERTAIN
PERSONS
WITH 
COLORECTAL CANCER 
‘‘SEC. 1920D. A State may elect to apply the provi-
sions of section 1920B to individuals described in section 
1902(kk) (relating to certain colorectal cancer patients) 
in the same manner as such section applies to individuals 
described in section 1902(aa) (relating to certain breast 
or cervical cancer patients).’’. 
(B) CONFORMING AMENDMENTS.— 
(i) Section 1902(a)(47) of the Social 
Security Act (42 U.S.C. 1396a(a)(47)), as 
amended by section 2303(b)(2) of the Pa-
tient Protection and Affordable Care Act 
(Public Law 111–148), is amended— 
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(I) in subparagraph (A)— 
(aa) by striking ‘‘and’’ after 
‘‘section 1920’’ and inserting a 
comma; 
(bb) by striking ‘‘and’’ after 
‘‘with such section’’ each place it 
occurs and inserting a comma 
each such place; and 
(cc) by inserting before the 
semicolon at the end the fol-
lowing: ‘‘, and provide for making 
medical assistance available to in-
dividuals described in section 
1920D during a presumptive eli-
gibility period in accordance with 
such section’’; and 
(II) in subparagraph (B), by 
striking ‘‘or 1920C’’ and inserting 
‘‘1920C, or 1920D’’. 
(ii) Section 1903(u)(1)(d)(v) of such 
Act (42 U.S.C. 1396b(u)(1)(d)(v)), as 
amended by section 2202(b) of the Patient 
Protection and Affordable Care Act (Public 
Law 111–148), is further amended— 
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(I) by striking ‘‘or for’’ and in-
serting ‘‘, for’’; and 
(II) by inserting before the pe-
riod the following: ‘‘, or for medical 
assistance provided to an individual 
described in section 1920D during a 
presumptive eligibility period under 
such section’’. 
(3) ENHANCED MATCH.—The first sentence of 
section 1905(b) of the Social Security Act (42 
U.S.C. 1396d(b)) is amended— 
(A) by striking ‘‘and’’ before ‘‘(4)’’; and 
(B) by inserting before the period at the 
end the following: ‘‘, and (5) the Federal med-
ical assistance percentage shall be equal to the 
enhanced FMAP described in section 2105(b) 
with respect to medical assistance provided to 
individuals who are eligible for such assistance 
only 
on 
the 
basis 
of 
section 
1902(a)(10)(A)(ii)(XXIII)’’. 
(4) EFFECTIVE DATE.—The amendments made 
by this section apply to medical assistance for items 
and services furnished on or after October 1, 2011, 
without regard to whether final regulations to carry 
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out such amendments have been promulgated by 
such date. 
(c) MOBILE MEDICAL VAN GRANT PROGRAM.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this subsection as 
the ‘‘Secretary’’), acting through the Administrator 
of the Health Resources and Services Administra-
tion, shall award grants to eligible entities for the 
development and implementation of a mobile medical 
van program that shall provide cancer screening 
services that are recommended with a grade of A or 
B by the United States Preventative Services Task 
Force of the Agency for Healthcare Research and 
Quality to communities that are underserved and 
suffer from barriers to access to high quality cancer 
prevention care. 
(2) ELIGIBLE ENTITIES.—To be eligible to re-
ceive a grant under paragraph (1), and entity 
shall— 
(A) be a consortium of public and private 
entities (such as academic medical centers, uni-
versities, hospitals, and non profit organiza-
tions); 
(B) submit to the Secretary an application 
at such time, in such manner, and containing 
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such information as the Secretary shall require, 
including— 
(i) a description of the manner in 
which the applicant intends to use funds 
received under the grant; 
(ii) a description of the manner in 
which the applicant will evaluate the im-
pact and effectiveness of the health care 
services provided under the program car-
ried out under the grant; 
(iii) a plan for sustaining activities 
and services funded under the grant after 
Federal support for the program has 
ended; 
(iv) a plan for the referral of patients 
to other health care facilities if additional 
services are needed; 
(v) a protocol for the transfer of pa-
tients in the event of a medical emergency; 
(vi) a plan for advertising the services 
of the mobile medical van to the commu-
nities targeted for health care services; and 
(vii) a plan to educate patients about 
the availability of federally funded medical 
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insurance programs for which such pa-
tients, or their children, may qualify; and 
(C) agree that amounts under the grant 
will be used to supplement, and not supplant, 
other funds (including in-kind contributions) 
used by the entity to carry out activities for 
which the grant is awarded. 
(3) USE
OF
FUNDS.—An entity shall use 
amounts received under a grant under this sub-
section to do any of the following: 
(A) Purchase or lease a mobile medical 
van. 
(B) Make repairs and provide maintenance 
for a mobile medical van. 
(C) Purchase or lease telemedicine equip-
ment that is reasonable and necessary to oper-
ate the mobile medical van. 
(D) Purchase medical supplies and medica-
tion that are necessary to provide health care 
services on the mobile medical van. 
(E) Retain medical professionals with ex-
pertise and experience in providing cancer 
screening services to underserved communities 
to provide health care services on the mobile 
medical van. 
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(4) MATCHING REQUIREMENTS.— 
(A) IN
GENERAL.—With respect to the 
costs of a mobile medical van program to be 
carried out under a grant under this subsection, 
the grantee shall make available (directly or 
through donations from public or private enti-
ties) non-Federal contributions toward such 
costs in an amount that is not less than the 
amount of the Federal funds provided under 
this grant. 
(B) DETERMINATION
OF
AMOUNT
CON-
TRIBUTED.—Non-Federal 
contributions 
re-
quired under subparagraph (A) may be in cash 
or in-kind, fairly evaluated, including plant, 
equipment, or services. Amounts provided by 
the Federal Government, or services assisted or 
subsidized to any significant extent by the Fed-
eral Government, may not be included in deter-
mining the amount of such non-Federal con-
tributions. 
(C) WAIVER.—The Secretary may waive 
the requirement established in subparagraph 
(A) if— 
(i) the Secretary determines that such 
waiver is justified; and 
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(ii) the Secretary publishes the ration-
ale for such waiver in the Federal Register. 
(D) RETURN OF FUNDS.—An entity that 
receives a grant under this section that fails to 
comply with subparagraph (A) shall return to 
the Secretary an amount equal to the difference 
between— 
(i) the amount provided under the 
grant; and 
(ii) the amount of matching funds ac-
tually provided by the grantee. 
(5) CONSIDERATIONS IN MAKING GRANTS.—In 
awarding grants under this subsection, the Secretary 
shall give preference to eligible entities— 
(A) that will provide cancer screening serv-
ices in underserved areas; and 
(B) that on the date on which the grant is 
awarded, have a mobile medical van that is non-
functioning due to the need for necessary me-
chanical repairs. 
(6) LIMITATION ON DURATION AND AMOUNT OF 
GRANT.—A grant under this subsection shall be for 
a 2-year period, except that the Secretary may waive 
such limitation and extend the grant period by an 
additional year. The amount awarded to an entity 
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under such grant for a fiscal year shall not exceed 
$200,000. 
(7) EVALUATION.—Not later than 1 year after 
the date on which a grant awarded to an entity 
under this subsection expires, the entity shall submit 
to the Secretary the results of an evaluation to be 
conducted by the entity concerning the effectiveness 
of the program carried out under the grant. 
(8) REPORT.—Not later than 18 months after 
grants are first awarded under this subsection, the 
Secretary shall submit to the Committee on Appro-
priations of the Senate and the Committee on Ap-
propriations of the House of Representatives a re-
port on the results of activities carried out with 
amounts received under such grants. 
(9) DEFINITIONS.—In this section: 
(A) MOBILE
MEDICAL
VAN.—The term 
‘‘mobile medical van’’ means a mobile vehicle 
that is equipped to provide non-urgent medical 
services and health care counseling to patients 
in underserved areas. 
(B) UNDERSERVED AREA.—The term ‘‘un-
derserved area’’, with respect to the location of 
patients receiving medical treatment, means a 
‘‘medically underserved community’’ as defined 
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in section 799B(6) of the Public Health Service 
Act (42 U.S.C. 295p(6)). 
SEC. 7. EARLY RECOGNITION AND TREATMENT OF CANCER 
THROUGH USE OF BIOMARKERS. 
(a) PROMOTION OF THE DISCOVERY AND DEVELOP-
MENT OF BIOMARKERS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the 
‘‘Secretary’’), in consultation with appropriate Fed-
eral agencies including the National Institutes of 
Health, the National Cancer Institute, the Food and 
Drug Administration, and the National Institute of 
Standards and Technology, and extramural experts 
as appropriate, shall establish and coordinate a pro-
gram to award contracts to eligible entities to sup-
port the development of innovative biomarker dis-
covery technologies. All activities under this section 
shall be consistent with and complement the ongoing 
efforts of the Oncology Biomarker Qualification Ini-
tiative and the Reagan-Udall Foundation of the 
Food and Drug Administration. 
(2) LEAD
AGENCY.—Not later than 2 years 
after the date of enactment of this Act, the Sec-
retary shall designate a lead Federal agency to ad-
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minister and coordinate the program established 
under paragraph (1). 
(3) ELIGIBILITY.—To be eligible to enter into a 
contract under paragraph (1), an entity shall submit 
to the Secretary an application at such time, in such 
manner, and containing such information as the Sec-
retary may require. Such information shall be suffi-
cient to enable the Secretary to— 
(A) promote the scientific review of such 
contracts in a timely fashion; and 
(B) contain the capacity to perform the 
necessary analysis of contract applications, in-
cluding determinations as to the intellectual ex-
pertise of applicants. 
(4) REQUIREMENT.—In awarding contracts 
under this subsection, the lead agency shall consider 
whether the research involved will result in the de-
velopment of quantifiable biomarkers of cell sig-
naling pathways that will have the broadest applica-
bility across different tumor types or different dis-
eases. 
(5) INTERNATIONAL
CONSORTIA.—The Sec-
retary shall designate one of the Federal entities de-
scribed in paragraph (1) to establish an inter-
national private-public consortia to develop and 
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share methods and precompetitive data on the vali-
dation and qualification of cancer biomarkers for 
specific uses. 
(b) CLINICAL STUDY GUIDELINES.—Not later than 
1 year after the date of enactment of this Act, the Com-
missioner of Food and Drugs, the Administrator of the 
Centers for Medicare & Medicaid Services, and the Direc-
tor of the National Cancer Institute shall jointly develop 
guidelines for the conduct of clinical studies designed to 
generate clinical data relating to cancer care and treat-
ment biomarkers that is adequate for review by each such 
Federal entity. Such guidelines shall be designed to assist 
in optimizing clinical study design and to strengthen the 
evidence base for evaluations of studies related to cancer 
biomarkers. 
(c) DEMONSTRATION PROJECT.— 
(1) IN GENERAL.—The Secretary, in consulta-
tion with the Commissioner of Food and Drugs and 
the Administrator of the Agency for Healthcare Re-
search and Quality, shall carry out a demonstration 
project that provides for a limited regional assess-
ment of biomarker tests to facilitate the controlled 
and limited use of a risk assessment measure with 
an intervention that may consist of a biomarker test. 
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(2) PROCEDURES.—As a component of the 
demonstration project under paragraph (1), the 
Commissioner of Food and Drugs, in consultation 
with other relevant agencies, shall establish proce-
dures that independent research entities shall follow 
in conducting high quality assessments of efficacy of 
biomarker tests. 
(d) POSTMARKET SURVEILLANCE.—The Food and 
Drug Administration and the Centers for Medicare & 
Medicaid Services shall assess quality and accuracy of bio-
marker tests through appropriate postmarket surveillance 
and other means, as necessary and appropriate to the mis-
sion of each such agency. 
(e) ESTABLISHMENT AND OPERATION OF RESEARCH 
CENTERS FOR THE STUDY OF BIOMARKERS FOR RISK 
STRATIFICATION AND EARLY DETECTION OF CANCERS 
WITH SURVIVAL RATES OF LESS THAN 50 PERCENT.— 
(1) IN GENERAL.—The Director of the National 
Cancer Institute, in consultation with the directors 
of other relevant institutes and centers of the Na-
tional Institutes of Health and the Department of 
Defense, shall enter into cooperative agreements 
with, or make grants to, public or nonprofit entities 
to establish and operate centers to conduct research 
on biomarkers for use in risk stratification for, and 
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the early detection and screening of, cancer with a 
five year survival rate of less than 50 percent. Each 
center shall be known as an Early Detection Bio-
marker Center of Excellence. 
(2) RESEARCH
FUNDED.—Federal payments 
made under a cooperative agreement or grant under 
paragraph (1) may be used for research on any of 
the following: 
(A) The development and characterization 
of new biomarkers, and the refinement of exist-
ing biomarkers, for cancers with a five-year sur-
vival rate of less than 50 percent. 
(B) The clinical and laboratory validation 
of such biomarkers, including technical develop-
ment, standardization of assay methods, sample 
preparation, reagents, reproducibility, port-
ability, and other refinements. 
(C) The development and implementation 
of clinical and epidemiological research on the 
utilization of biomarkers for the early detection 
and screening of cancers with a five-year sur-
vival rate of less than 50 percent. 
(D) The development and implementation 
of new repositories for additional tissue, urine, 
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