the ‘‘Secretary’’) shall establish a demonstration 
project under this section (in this section referred to 
as the ‘‘demonstration’’) to evaluate new approaches 
to coding and payment under the medicare program 
for clinical diagnostic laboratory tests included in 
the demonstration (in this section referred to as ‘‘in-
cluded tests’’). 
(2) DURATION.—The demonstration and any 
payment amounts assigned under the demonstration 
shall apply solely to claims submitted for included 
tests during the 12-calendar-quarter period that be-
gins with the first day of the first calendar quarter 
to begin at least 250 days after the date of the en-
actment of this Act. 
(3) SCOPE.—The demonstration shall apply on 
a national basis to included tests in all settings for 
which payment for such tests would (but for the 
demonstration) be made under the fee schedules and 
limitation 
amounts 
established 
under 
section 
1833(h) of the Social Security Act (42 U.S.C. 
1395l(h)). 
(4) ISSUANCE OF TEMPORARY HCPCS CODES; 
CONTINUED
APPLICATION
OF
SUCH
CODES.—The 
Secretary shall issue a temporary code or codes 
under the Health Care Procedure Coding System 
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(HCPCS) when needed for an included test, and 
such code or codes— 
(A) shall continue to apply to the test until 
a permanent code or codes is assigned; and 
(B) shall not cease to apply solely because 
the demonstration ends. 
(b) INCLUDED TESTS.— 
(1) ELIGIBLE TESTS.—A clinical diagnostic lab-
oratory test is eligible to be an included test under 
the demonstration if— 
(A) the test is a new or existing molecular 
diagnostic test that (but for its inclusion in the 
demonstration) could be paid under the fee 
schedules and national limitation amount estab-
lished under section 1833(h) of the Social Secu-
rity Act (42 U.S.C. 1395l(h)) for the test; and 
(B) there is the prospect— 
(i) for wide usage of the test in mul-
tiple geographic areas; and 
(ii) that development of a new code, 
or payment, or both, for the test under the 
demonstration will result in reduced ad-
ministrative complexity and improved effi-
ciency. 
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(2) INCLUDED
TESTS.—A clinical diagnostic 
laboratory test shall be treated as an included test 
if— 
(A) an interested party submits a request 
to the standing panel established under sub-
section (c) that the test be included in the dem-
onstration; and 
(B) the standing panel determines that the 
test is an eligible test under paragraph (1); or 
(3) DEFINITIONS.—For purposes of this sec-
tion— 
(A) the term ‘‘molecular diagnostic test’’ 
means a clinical diagnostic laboratory test per-
formed on deoxyribonucleic (DNA), ribonucleic 
acid (RNA), or protein that is drawn from a 
human being or from a disease-causing orga-
nism for genomic or proteomic analysis; and 
(B) the term ‘‘interested party’’ means, 
with respect to a request for inclusion of molec-
ular diagnostic test in the demonstration, an in-
dividual entitled to benefits under title XVIII of 
the Social Security Act, a manufacturer of the 
test, a clinical laboratory offering the test, a 
professional society, the Centers for Medicare & 
Medicaid Services, a private payer for such test, 
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