I 
108TH CONGRESS 
1ST SESSION 
H. R. 569
To amend title XVIII of the Social Security Act to establish procedures 
for determining payment amounts for new clinical diagnostic laboratory 
tests for which payment is made under the Medicare Program. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 5, 2003
Ms. DUNN (for herself, Mr. MCDERMOTT, Mr. RAMSTAD, Mr. DEUTSCH, and 
Mr. FERGUSON) introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committee 
on Ways and Means, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to establish 
procedures for determining payment amounts for new 
clinical diagnostic laboratory tests for which payment 
is made under the Medicare Program.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medicare Patient Ac-
cess to Preventive and Diagnostic Tests Act of 2003’’.
SEC. 2. CODING AND PAYMENT PROCEDURES FOR NEW 
CLINICAL DIAGNOSTIC LABORATORY TESTS 
UNDER MEDICARE. 
(a) DETERMINING PAYMENT BASIS 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: 
‘‘(9)(A) The Secretary shall establish proce-
dures for determining the basis for, and amount of, 
payment under this subsection for any clinical diag-
nostic laboratory test with respect to which a new or 
substantially revised HCPCS code is assigned on or 
after January 1, 2004 (hereinafter in this paragraph 
and paragraph (10) referred to as ‘new tests’). Such 
procedures shall provide that—
‘‘(i) the payment amount for such a test 
will be established only on—
‘‘(I) the basis described in paragraph 
(10)(A); or 
‘‘(II) the basis described in paragraph 
(10)(B); and 
‘‘(ii) the Secretary will determine whether 
the payment amount for such a test is estab-
lished on the basis described in paragraph 
(10)(A) or the basis described in paragraph 
(10)(B) only after the process described in sub-
paragraph (B) has been completed with respect 
to such test. 
‘‘(B) 
Determinations 
under 
subparagraph 
(A)(ii) shall be made only after the Secretary—
‘‘(i) makes available to the public (through 
an Internet site and other appropriate mecha-
nisms) a list that includes any such test for 
which establishment of a payment amount 
under paragraph (10) is being considered for a 
year; 
‘‘(ii) on the same day such list is made 
available, causes to have published in the Fed-
eral Register notice of a meeting to receive 
comments and recommendations (including the 
data upon which such recommendations are 
based) from the public on the appropriate basis 
under paragraph (10) for establishing payment 
amounts for the tests on such list; 
‘‘(iii) not less than 30 days after publica-
tion of such notice, convenes a meeting to re-
ceive such comments and recommendations, 
with such meeting—
‘‘(I) including representatives of all 
entities within the Centers for Medicare & 
Medicaid Services (hereinafter in this para-
graph referred to as ‘CMS’) that will be
involved in determining the basis on which 
payment amounts will be established for 
such tests under paragraph (10) and im-
plementing such determinations; 
‘‘(II) encouraging the participation of 
interested parties, including beneficiaries, 
device manufacturers, clinical laboratories, 
laboratory professionals, pathologists, and 
prescribing physicians, through outreach 
activities; and 
‘‘(III) 
affording 
opportunities 
for 
interactive dialogue between representa-
tives of CMS and the public; and 
‘‘(iv) taking into account the comments 
and recommendations received at such meeting, 
develops and makes available to the public 
(through an Internet site and other appropriate 
mechanisms) a list of proposed determinations 
with respect to the appropriate basis for estab-
lishing a payment amount under paragraph 
(10) for each such code, together with an expla-
nation of the reasons for each such determina-
tion, and the data on which the determination 
is based.
The Secretary may convene such further public 
meetings to receive public comment on payment 
amounts for new tests under this subsection as the 
Secretary determines appropriate. 
‘‘(C) Under the procedures established pursuant 
to subparagraph (A), the Secretary shall—
‘‘(i) identify the rules and assumptions to 
be applied by the Secretary in considering and 
making determinations of whether the payment 
amount for a new test should be established on 
the basis described in paragraph (10)(A) or the 
basis described in paragraph (10)(B); 
‘‘(ii) make available to the public the data 
(other than proprietary data) considered in 
making such determinations; and 
‘‘(iii) provide for a mechanism under 
which—
‘‘(I) an interested party may request 
an administrative review of an adverse de-
termination; 
‘‘(II) upon the request of an inter-
ested party, an administrative review is 
conducted with respect to an adverse deter-
mination; and
‘‘(III) such determination is revised, 
as necessary, to reflect the results of such 
review. 
‘‘(D) For purposes of this paragraph and 
paragraph (10)—
‘‘(i) the term ‘HCPCS’ refers to the 
Healthcare Common Procedure Coding 
System; and 
‘‘(ii) a code shall be considered to be 
‘substantially revised’ if there is a sub-
stantive change to the definition of the test 
or procedure to which the code applies 
(such as a new analyte or a new method-
ology for measuring an existing analyte-
specific test). 
‘‘(10)(A) Notwithstanding paragraphs (1), (2), 
and (4), if a new test is clinically similar to a test 
for which a fee schedule amount has been estab-
lished under paragraph (5), the Secretary shall pay 
the same fee schedule amount for the new test. In 
determining whether tests are clinically similar for 
purposes of this paragraph, the Secretary may not 
take into account economic factors. 
‘‘(B)(i) Notwithstanding paragraphs (1), (2), 
(4), and (5), if a new test is not clinically similar to
a test for which a fee schedule has been established 
under paragraph (5), payment under this subsection 
for such test shall be made on the basis of the lesser 
of—
‘‘(I) the actual charge for the test; or 
‘‘(II) an amount equal to 60 percent (or in 
the case of a test performed by a qualified hos-
pital (as defined in paragraph (1)(D)) for out-
patients of such hospital, 62 percent) of the 
prevailing charge level determined pursuant to 
the third and fourth sentences of section 
1842(b)(3) for the test for a locality or area for 
the year (determined without regard to the year 
referred to in paragraph (2)(A)(i), or any na-
tional limitation amount under paragraph 
(4)(B), and adjusted annually by the percent-
age increase or decrease under paragraph 
(2)(A)(i)); 
until the beginning of the third full calendar year 
that begins 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 fee schedule amount pursuant to 
clause (ii). 
‘‘(ii) Notwithstanding paragraphs (2) and (4), 
and (5), the fee schedule amount for a clinical diag-
nostic laboratory test described in clause (i) that is 
performed—
‘‘(I) during the first calendar year after 
clause (i) ceases to apply to such test, shall be 
an amount equal to the national limitation 
amount that the Secretary determines (con-
sistent with clause (iii)) would have applied to 
such test under paragraph (4)(B)(viii) during 
the preceding calendar year, adjusted by the 
percentage increase or decrease determined 
under paragraph (2)(A)(i) for such first cal-
endar year; and 
‘‘(II) during a subsequent year, is the fee 
schedule amount determined under this clause 
for the preceding year, adjusted by the percent-
age increase or decrease that applies under 
paragraph (5)(A) for such year. 
‘‘(iii) For purposes of clause (ii)(I), the national 
limitation amount for a test shall be set at 100 per-
cent of the median of the payment amounts deter-
mined under clause (ii)(I) for all payment localities
or areas for the last calendar year for which pay-
ment for such test was determined under clause (i). 
‘‘(iv) Nothing in clause (ii) shall be construed 
as prohibiting the Secretary from applying (or au-
thorizing the application of) the comparability provi-
sions of the first sentence of such section 1842(b)(3) 
with respect to amounts determined under such 
clause.’’. 
(b) ESTABLISHMENT OF NATIONAL FEE SCHEDULE 
AMOUNTS.—
(1) IN GENERAL.—Section 1833(h) of the So-
cial Security Act, as amended by subsection (a), is 
further amended—
(A) in paragraph (2), by striking ‘‘para-
graph (4)’’ and inserting in lieu thereof ‘‘para-
graphs (4), (5), and (10)’’; 
(B) in paragraph (4)(B)(viii), by inserting 
‘‘and before January 1, 2004,’’ after ‘‘Decem-
ber 31, 1997,’’; 
(C) by redesignating paragraphs (5), (6), 
and (7), as paragraphs (6), (7), and (8), re-
spectively; and 
(D) by inserting after paragraph (4) the 
following:
‘‘(5) Notwithstanding paragraphs (2) and (4), 
the Secretary shall set the fee schedule amount for 
a test (other than a test to which paragraph 
(10)(B)) applies) at—
‘‘(A) for tests performed during 2004, an 
amount equal to the national limitation amount 
for that test for 2003, and adjusted by the per-
centage increase or decrease determined under 
paragraph (2)(A)(i) for such year; and 
‘‘(B) for tests performed during a year 
after 2004, the amount determined under this 
subparagraph for the preceding year, adjusted 
by the percentage increase or decrease deter-
mined under paragraph (2)(A)(i) for such 
year.’’. 
(2) CONFORMING CHANGES.—Section 1833(a) 
of the Social Security Act (42 U.S.C. 1395l(a)) is 
amended—
(A) in paragraph (1)(D)(i), by striking 
‘‘the limitation amount for that test determined 
under subsection (h)(4)(B),’’; and 
(B) in paragraph (2)(D)(i), by striking 
‘‘the limitation amount for that test determined 
under subsection (h)(4)(B),’’.
(c) MECHANISM FOR REVIEW OF ADEQUACY OF PAY-
MENT AMOUNTS.—Section 1833(h) of the Social Security 
Act, as amended by subsections (a) and (b), is further 
amended by adding at the end the following: 
‘‘(11) The Secretary shall establish a mecha-
nism under which—
‘‘(A) an interested party may request a 
timely review of the adequacy of the existing 
payment amount under this subsection fee for 
a particular test; and 
‘‘(B) upon the receipt of such a request, a 
timely review is carried out.’’. 
(d) PROHIBITION ON ASSIGNMENT OF CERTAIN NEW 
CODES.—The Secretary may not assign a code for a new 
clinical diagnostic laboratory test that differs from the 
code recommended by the American Medical Association 
Common Procedure Terminology Editorial Panel and re-
sults in lower payment than would be made if the Sec-
retary accepted such recommendation solely on the basis 
that the test is a test that may be performed by a labora-
tory with a certificate of waiver under section 353(d)(2) 
of the Public Health Service Act (42 U.S.C. 263a(d)(2)). 
(e) PROHIBITION ON APPLICATION OF LEAST COST-
LY ALTERNATIVE TO FEE SCHEDULE.—Section 1833(h) 
of the Social Security Act, as amended by subsections (a),