shall be open to the public and provide for public
participation.
(2) Under the procedures, the Secretary shall
identify the rules and assumptions to be applied in
considering the coding or payment determination,
and shall provide the sources and types of data to
be used in making such determination.
(3) Under the procedures, the Secretary shall
provide a clear statement of the basis for the deter-
mination.
(4) Under the procedures, the Secretary shall
make available to the public the data (other than
proprietary data) considered in making the deter-
mination.
(5) Under the procedures, the Secretary shall
consider and implement coding modifications under
procedures similar to those for HCPCS level II and
ICD–9–CM procedure and related codes.
(6) Under the procedures, the Secretary shall
provide for consistent instructions to carriers to
carry out their functions in setting prices for new
technologies that—
(A) are designed to establish fair and ap-
propriate payment levels reflecting market con-
ditions for such items and services; and
(B) in the case of clinical diagnostic lab-
oratory tests for which payment is made on a
fee schedule basis under title XVIII of the So-
cial Security Act, comply with the requirements
of section 1833(h)(8) of such Act (42 U.S.C.
1395l(h)(8)).
(7) Under the procedures, the Secretary shall
provide a mechanism under which an interested
party may request a timely review of the adequacy
of the existing fee for a particular item or service,
and upon receipt of such a request that such timely
review is carried out.
(8) Under the procedures, the Secretary shall
provide for a mechanism under which an interested
party may request administrative review of an ad-
verse coding or payment policy determination, and
shall provide for such review and, if necessary, revi-
sion of the determination.
(b) ESTABLISHING PAYMENT RATES FOR NEW LAB
TESTS.—Section 1833(h) of the Social Security Act (42
U.S.C. 1395l(h)) is amended by adding at the end the fol-
lowing:
‘‘(8)(A) Notwithstanding paragraphs (1), (2), and
(4), in the case of a clinical diagnostic laboratory test with
respect to which a code is first assigned under the Health
Care Financing Administration Common Procedure Cod-
ing System (hereinafter referred to as ‘HCPCS’) on or
after January 1, 2001, the Secretary shall provide for the
establishment of payment rates in accordance with sub-
paragraph (B) or (C).
‘‘(B) In the case of a clinical diagnostic laboratory
test described in subparagraph (A) with respect to which
the Secretary proposes to base payment on the fee sched-
ule amounts determined under paragraph (1) and the na-
tional limitation amount determined under paragraph (4)
for one or more similar clinical diagnostic laboratory tests,
the Secretary shall—
‘‘(i) cause to have published in the Federal
Register not later than July 1 of each calendar year
(beginning with calendar year 2001) the Secretary’s
proposal with respect to the appropriate fee schedule
amounts and national limitation amount for such
test for the following calendar year; and
‘‘(ii) provide an opportunity for the public to
comment on such proposal.
‘‘(C)(i) In the case of a clinical diagnostic laboratory
test described in subparagraph (A) with respect to which
payment is not determined in accordance with subpara-
graph (B)—
‘‘(I) payment under this subsection shall be
made on the basis of the prevailing charge level for
the test for a locality or area (determined without
regard to the percentage limitation or the base year
referred to in paragraph (2)(A)); and
‘‘(II) the limitation amounts referred to in sub-
section (a)(1)(D)(i), subsection (a)(2)(D)(i), and
paragraph (4)(B) shall not apply,
until the beginning of the third full calendar year that be-
gins on or after the date on which an HCPCS code is
first assigned with respect to such test, or, if later, the
beginning of the first calendar year that begins on or after
the date on which the Secretary determines that there are
sufficient claims data to establish a limitation amount
under paragraph (4)(B).
‘‘(ii) Notwithstanding paragraph (2)(A), the Sec-
retary shall—
‘‘(I) set the fee schedules under paragraph (1)
for a clinical diagnostic laboratory test described in
clause (i) for any calendar year beginning after the
base year at 100 percent of the prevailing charge
level for such test for the applicable region, State,
or area for the base year, adjusted annually (to be-
come effective on January 1 of each year) by the
percentage increase or decrease in the Consumer
Price Index for All Urban Consumers (United States
city average), and subject to such other adjustments
as the Secretary determines are justified by techno-
logical changes; and
‘‘(II) determine the limitation amount referred
to in subsection (a)(1)(D)(i), subsection (a)(2)(D)(i),
and paragraph (4)(B) for such test based on the fee
schedules set under subclause (I).
‘‘(iii) For purposes of clause (ii), the term ‘base year’
means, with respect to a clinical diagnostic laboratory test,
the last full calendar year during which payment for such
test was determined in accordance with clause (i).’’.
(c) PROHIBITION.—The Secretary may not assign a
code for a new clinical diagnostic laboratory test that dif-
fers from the code recommended by the American Medical
Association Common Procedure Terminology Editorial
Panel and results in lower payment than would be made
if the Secretary accepted such recommendation solely on
the basis that the test is a test that may be performed
by a laboratory with a certificate of waiver under section
353(d)(2) of the Public Health Service Act (42 U.S.C.
263a(d)(2)).
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