under section 701(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 371(h)). 
(4) AUTHORITY TO RECOMMEND REVISIONS TO, 
AND
TO
REVISE, 
COST
INTERVALS
OR
COST 
BANDS.—Nothing in this section shall be construed 
as limiting the authority of the standing panel to 
recommend, or the Secretary to adopt, new cost in-
tervals or cost bands to accommodate changes in 
technology. 
(f) REVIEW PROCESS.— 
(1) REQUESTS FOR INCLUSION IN DEMONSTRA-
TION.—An interested party may submit a request 
for inclusion of a test in the demonstration to the 
standing panel at any time during a calendar year 
for which the demonstration is in effect, except that 
the standing panel may decline to review and make 
recommendations or determinations with respect to 
any request that would result in a requested coding 
or payment determination being effective for a pe-
riod of less than 4 calendar quarters. 
(2) 
RECOMMENDATIONS
OF
STANDING 
PANEL.—The standing panel shall review each re-
quest for a coding or payment determination that is 
made with respect to an included test. Applying the 
standards and parameters developed under sub-
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section (e)(2)(A), the panel shall make a rec-
ommendation to the Secretary with respect to each 
requested determination. 
(3) SECRETARIAL DETERMINATIONS.— 
(A) QUARTERLY
DETERMINATIONS.—The 
Secretary shall make determinations on whether 
to grant requested coding and payment deter-
minations on a quarterly basis, but is not re-
quired to make such a determination for every 
request made (or with respect to which a rec-
ommendation is received from the standing 
panel) during a particular quarter. 
(B) 
TIME
FRAMES
FOR
DETERMINA-
TIONS.—Determinations of the Secretary shall 
be made in a timely manner in accordance with 
time frames developed by the standing panel 
taking into account factors such as when a re-
quest (and a recommendation with respect to 
the request) is made during a quarter, the par-
ticular type of test involved, and the staffing 
and resources that may be required to review 
the request. 
(g) PAYMENT METHODOLOGY.— 
(1) IN GENERAL.—Included tests shall be paid 
in accordance with a methodology, developed by the 
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standing panel, that establishes cost intervals or cost 
bands in a manner similar to those that are used as 
new technology ambulatory payment classification 
groups for hospital outpatient services under section 
1833(t) of the Social Security Act (42 U.S.C. 
1395l(t)), with a test being assigned to the cost in-
terval or cost band that most closely approximates 
the typical direct and indirect costs (including test 
acquisition costs) of the test for a laboratory. Tests 
that are included tests for purposes of this section 
shall be excluded from any demonstration project 
under section 1847(e) of such Act (42 U.S.C. 
1395w–3(e)). 
(2) PANEL RECOMMENDATIONS; SECRETARIAL 
DETERMINATIONS.— 
(A) 
RECOMMENDATIONS; 
SECRETARIAL 
DETERMINATIONS.—The standing panel shall 
recommend to the Secretary a cost interval or 
cost band to which an included test should be 
assigned, and the Secretary may assign such 
test to such band or interval or to another band 
or interval the Secretary determines to more 
closely approximate the typical direct and indi-
rect costs (including test acquisition costs) of 
the test. 
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(B) EXPLANATION
OF
DETERMINATION 
THAT
DIFFERS
FROM
RECOMMENDATION.—If 
the Secretary assigns a test to a cost interval 
or band other than that recommended by the 
standing panel, the Secretary shall provide a 
detailed written explanation of the reasons for 
determining that such other interval or band is 
more appropriate. 
(3) EFFECTIVE DATE OF SECRETARIAL DETER-
MINATION.—A determination by the Secretary with 
respect to a coding or payment determination for an 
included test shall become effective as of the first 
day of the calendar quarter following the calendar 
quarter in which the determination is made. 
(4) PERIODIC
LOOK-BACKS
OF
INTERVAL
OR 
BAND ASSIGNMENTS.—At the request of the inter-
ested party that submitted the initial request for a 
test to be included in the demonstration or of a 
member of the standing panel, the standing panel 
may review the appropriateness of the payment in-
terval or band to which the test is assigned and 
make a recommendation to the Secretary that the 
assignment be changed. The Secretary may accept 
or reject such recommendation, and if the rec-
ommendation is rejected, the Secretary shall provide 
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a detailed explanation of the reasons for such rejec-
tion. 
(5) PUBLICATION OF DETERMINATIONS.—The 
Secretary shall publish determinations under this 
subsection in a timely manner on an appropriate 
internet site. 
(h) REPORTS TO CONGRESS.— 
(1) IN GENERAL.—The Secretary shall submit 
interim and final reports on the demonstration to 
the Committees on Ways and Means and Energy 
and Commerce of the House of Representatives and 
the Committee on Finance of the Senate. The in-
terim report shall be submitted not later than the 
close of the second year of the demonstration, and 
the final report shall be submitted not later than 
180 days after the close of the demonstration. 
(2) CONTENT OF REPORTS.—The reports sub-
mitted under paragraph (1) shall include interim 
and final— 
(A) determinations on whether coding and 
payment assignments under the demonstration 
provide for— 
(i) more equitable and accurate pay-
ment for included tests; and 
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(ii) reduced administrative complexity, 
improved efficiency, and improved access 
to care; and 
(B) recommendations on— 
(i) whether the alternative mechanism 
for determining payment and coding for in-
cluded tests should be continued for such 
tests beyond the 12-calendar-quarter pe-
riod the demonstration is in effect; and 
(ii) whether the application of such 
mechanism should be expanded to include 
other new clinical diagnostic laboratory 
tests for which payment would otherwise 
be made under the fee schedules and limits 
established under section 1833(h) of the 
Social Security Act (42 U.S.C. 1395l(h)). 
(3) COMMENTS
BY
STANDING
PANEL.—The 
standing panel shall submit comments to the com-
mittees referred to in paragraph (1) on the interim 
and final reports of the Secretary. 
(i) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated for each of fiscal years 
2007 through 2012, such sums as may be necessary to 
carry out this section. 
Æ 
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