(iii) CLAIMS DATA.—Data from claims 
for which payment is made under part B 
of title XVIII of the Social Security Act. 
(iv) 
LABORATORY
CHARGES.— 
Amounts charged by laboratories to self- 
pay patients for the new test. 
(v) PRIVATE
INSURANCE
RATES.— 
Amounts paid to laboratories for such new 
test under private health insurance cov-
erage offered in the group market and the 
individual market. 
(vi) ADVISORY PANEL RECOMMENDA-
TIONS.—The findings and recommenda-
tions of the independent advisory panel 
convened under paragraph (2) with respect 
to that new test and any comments re-
ceived during the open meeting of the advi-
sory panel. 
(vii) 
ADDITIONAL
FACTORS.—Such 
other factors as the Secretary may specify. 
(2) INPUT FROM PATIENTS, CLINICIANS, AND 
TECHNICAL EXPERTS.— 
(A) REQUIREMENT FOR INDEPENDENT AD-
VISORY
PANEL.—The Secretary shall convene 
an independent advisory panel from which the 
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Secretary shall request information and rec-
ommendations regarding any new test (as re-
ferred to under subparagraph (A) of section 
1833(h)(8) of the Social Security Act (42 
U.S.C. 1395l(h)(8))) for which payment is 
made under such section, including technical, 
clinical, and quality information. 
(B) COMPOSITION OF INDEPENDENT ADVI-
SORY PANEL.—The independent advisory panel 
shall be comprised of 19 members, including— 
(i) 4 individuals with expertise and ex-
perience with advanced clinical diagnostic 
laboratory tests, including expertise in the 
technical characteristics of the new test; 
(ii) 3 representatives of patients, in-
cluding a patient representative for rare 
disorders; 
(iii) 3 clinicians who use results of the 
new test in patient care; 
(iv) 3 individuals with expertise in the 
requirements to develop, validate, and per-
form the new test; 
(v) 2 laboratorians; 
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(vi) 
experts 
in 
the 
area 
of 
pharmacoeconomics or health technology 
assessment; and 
(vii) 2 individuals with expertise on 
the impact of new tests on quality of pa-
tient care, including genetic counselors. 
(C) TERMS.—A member of the panel shall 
be appointed to serve a term of 6 years, except 
with respect to the members first appointed, 
whose terms of appointment shall be staggered 
evenly over 2-year increments. 
(D) EXPERT
CONSULTANTS.—The Sec-
retary may include to serve temporarily on the 
panel individuals who have expertise pertaining 
to the new test involved. 
(E) OPEN MEETINGS.—The Secretary shall 
receive or review the findings and recommenda-
tions of the independent advisory panel with re-
spect to the new tests described in subpara-
graph (A) involved during a meeting open to 
the public and provide opportunity for public 
comment. 
(F) CLARIFICATION
OF
AUTHORITY
OF 
SECRETARY TO CONSULT CARRIERS.—Nothing 
in this section shall be construed as affecting 
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the authority of the Secretary to consult with 
appropriate Medicare administrative contrac-
tors. 
(b) PROCESS
FOR ASSIGNMENT
OF TEMPORARY 
CODES FOR DIAGNOSTIC TESTS.—The Secretary shall es-
tablish a process for application for the assignment of a 
temporary national HCPCS code to uniquely identify a di-
agnostic test until a permanent national HCPCS code is 
available for assignment to that test. Assignments of a 
temporary national HCPCS code shall occur on a quar-
terly basis. The Secretary shall provide public notice 
through the Centers for Medicare & Medicaid Services 
Web site of applications made for such temporary national 
HCPCS codes. Upon assignment of a temporary code 
under this process, the Secretary shall treat such test as 
a new test for purposes of section 1833(h)(8) of the Social 
Security Act. 
(c) DEVELOPMENT OF FURTHER IMPROVEMENTS IN 
RATE-SETTING PROCESSES.—The Secretary shall analyze 
the process used for the gapfilling procedure used in deter-
mining payment amounts for new clinical diagnostic lab-
oratory tests under section 1833(h)(8) of the Social Secu-
rity Act. Taking into account the changes made by this 
section, the Secretary shall identify further changes to im-
prove the accuracy and appropriateness of resulting rates 
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and the openness, transparency, and predictability of the 
process. The Secretary shall examine what and how many 
entities should perform gapfilling, under contract or other-
wise, and how to ensure that the process is informed by 
appropriate expertise and proceeds in a transparent and 
accountable manner. The Secretary shall implement im-
provements in the process, insofar as these are possible 
under the law through regulations, after public notice and 
opportunity for comment. For changes the Secretary de-
termines would require a change in law, the Secretary 
shall transmit recommendations to the Speaker of the 
House and the President of the Senate not later than July 
1, 2013. 
(d) DEFINITIONS.—For purposes of this section: 
(1) NEW
CLINICAL
DIAGNOSTIC
LABORATORY 
TESTS.—The term ‘‘new clinical diagnostic labora-
tory test’’ means a clinical diagnostic laboratory 
test— 
(A) that is assigned a new or substantially 
revised code on or after January 1, 2013; or 
(B) for which an application for a tem-
porary national HCPCS code is made under 
subsection (b) on or after January 1, 2013. 
(2) SELF-PAY
PATIENT.—The term ‘‘self-pay 
patient’’ means, with respect to a health care item 
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or service, an individual who pays out of pocket for 
such item or service and who does not have health 
insurance coverage for such item or service. 
(e) EFFECTIVE DATE.—This section shall take effect 
on the date of enactment of this Act, and shall apply with 
respect to new clinical diagnostic laboratory tests. 
Æ 
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