I 
109TH CONGRESS 
2D SESSION 
H. R. 5369 
To amend title XVIII of the Social Security Act to improve payments under 
the Medicare clinical laboratory fee schedule. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 11, 2006 
Mr. FERGUSON (for himself, Mr. ENGLISH of Pennsylvania, Mr. RUSH, and 
Mr. THOMPSON of California) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce, and in addition to 
the Committee on Ways and Means, for a period to be subsequently de-
termined 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 improve 
payments under the Medicare clinical laboratory fee schedule. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE AND TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Medicare Clinical Laboratory Fee Schedule Improvement 
Act of 2006’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
VerDate Aug 31 2005 
00:23 May 14, 2006
Jkt 049196
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H5369.IH
H5369
ccoleman on PROD1PC71 with BILLS
Sec.
1. Short title and table of contents. 
TITLE I—NEAR-TERM CHANGES 
Sec.
101. Fee schedule and national limitation amounts for clinical diagnostic 
laboratory tests. 
Sec.
102. Issuance of regulations on gap-filling for medicare fee schedule for 
clinical diagnostic laboratory tests. 
Sec.
103. Increased transparency of process for determining fee schedule 
amounts for new tests. 
Sec.
104. Advance notice of clinical diagnostic laboratory test amounts being 
considered for adjustment under inherent reasonableness au-
thority. 
TITLE II—FUTURE REFORM 
Sec.
201. Establishment of medicare demonstration project to evaluate new 
approaches to coding and payment for certain molecular diag-
nostic tests. 
TITLE I—NEAR-TERM CHANGES 
SEC. 101. FEE SCHEDULE AND NATIONAL LIMITATION 
AMOUNTS FOR CLINICAL DIAGNOSTIC LAB-
ORATORY TESTS. 
(a) IN GENERAL.—Section 1833(h) of the Social Se-
curity Act (42 U.S.C. 1395l(h)) is amended by adding at 
the end the following new paragraph: 
‘‘(9)(A) For purposes of this paragraph: 
‘‘(i) The term ‘an amount determined under 
this subsection’ means, with respect to a clinical lab-
oratory test, the fee schedule amount determined 
under paragraph (2)(A)(i) for the test or the limita-
tion amount determined under paragraph (4)(B) for 
the test. 
‘‘(ii) The terms ‘appropriate medicare adminis-
trative contractor’ and ‘medicare administrative con-
VerDate Aug 31 2005 
00:23 May 14, 2006
Jkt 049196
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H5369.IH
H5369
ccoleman on PROD1PC71 with BILLS
tractor’ have the meaning given to such terms under 
section 1874A(a)(3). 
‘‘(iii) The term ‘erroneous decision’ means, with 
respect to the determination of an amount deter-
mined under this subsection, any decision, calcula-
tion, judgment or other action by the Secretary or 
a medicare administrative contractor that, based 
upon consideration of currently known facts, needs 
to be modified to produce a fair and equitable pay-
ment amount, except that such term does not in-
clude typographical or clerical errors. 
‘‘(iv) The term ‘non-governmental party’ in-
cludes— 
‘‘(I) a provider of services (as defined in 
section 1861(u)) that furnishes clinical diag-
nostic laboratory tests for which payment may 
be made under this subsection; 
‘‘(II) a supplier (as defined in section 
1861(d)) that furnishes such tests; and 
‘‘(III) a manufacturer of a test or of any 
supplies or equipment that are used in per-
forming such test. 
‘‘(B) An amount determined under this subsection 
may be changed solely on the basis of— 
VerDate Aug 31 2005 
00:23 May 14, 2006
Jkt 049196
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H5369.IH
H5369
ccoleman on PROD1PC71 with BILLS
‘‘(i) in the case of a change other than a change 
to correct an erroneous decision in determining such 
amount, the authority provided by the preceding 
provisions of this subsection, section 1842(b)(8), or 
any regulations, manual instructions, or other regu-
latory guidance implementing such provisions; or 
‘‘(ii) in the case of a change to correct an erro-
neous decision in determining such an amount, the 
authority provided by subparagraphs (C), (D), and 
(E). 
‘‘(C) Any erroneous decision in determining an 
amount under this subsection may be corrected only if— 
‘‘(i) a non-governmental party submits a re-
quest under subparagraph (D) or (E) for correction 
of the erroneous decision; and 
‘‘(ii) such party demonstrates, to an appro-
priate medicare administrative contractor under sub-
paragraph (D) or the Secretary under subparagraph 
(E), that an erroneous decision clearly was made. 
‘‘(D)(i) Any non-governmental party may request (in 
such form and manner as the Secretary may require) that 
the appropriate medicare administrative contractor change 
a fee schedule amount determined under paragraph 
(2)(A)(i) to correct an erroneous decision in determining 
such amount. 
VerDate Aug 31 2005 
00:23 May 14, 2006
Jkt 049196
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5369.IH
H5369
ccoleman on PROD1PC71 with BILLS
‘‘(ii) Any request under this subparagraph shall in-
clude a statement of the basis for the non-governmental 
party’s belief that an erroneous decision was made in de-
termining such amount, together with supporting evidence 
and a description of any additional data (other than data 
already in the possession of the appropriate medicare ad-
ministrative contractor) that— 
‘‘(I) is or may be in the possession of the Sec-
retary or another medicare administrative con-
tractor; and 
‘‘(II) is necessary to demonstrate that such an 
erroneous decision exists. 
‘‘(iii) If the Secretary or another medicare adminis-
trative contractor is identified as possessing or potentially 
possessing additional data identified by a non-govern-
mental party in a request under this subparagraph, the 
Secretary or such contractor, as the case may be, shall 
make available to the non-governmental party within 30 
days after the date of the submission of the request any 
data in their possession that meet the description of the 
additional data identified in such request, with appro-
priate safeguards to protect confidential and proprietary 
information. 
‘‘(iv) If additional data are made available to a non- 
governmental party under clause (iii), such party may 
VerDate Aug 31 2005 
00:23 May 14, 2006
Jkt 049196
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5369.IH
H5369
ccoleman on PROD1PC71 with BILLS
amend its request under this subparagraph to incorporate 
such data within 30 days after the date such data are 
made available to such party. 
‘‘(v) An appropriate medicare administrative con-
tractor to which a request is submitted under this sub-
paragraph shall make a determination with respect to 
whether to correct the decision that is identified as erro-
neous in the request not later than 60 days after the date 
of the submission of such request, or if later, the date of 
the submission of an amended request under clause (iv). 
Such contractor shall determine that the non-govern-
mental party submitting the request— 
‘‘(I) has demonstrated that an erroneous deci-
sion clearly was made, correct such erroneous deci-
sion, and increase the fee schedule amount as of the 
first day of the next calendar quarter to reflect the 
correction of such erroneous decision; or 
‘‘(II) has failed to demonstrate that an erro-
neous decision clearly was made and decline to 
change the fee schedule amount, 
and shall provide to the non-governmental party a written 
explanation of the basis for such determination. 
‘‘(vi) An appropriate medicare administrative con-
tractor to which a request is submitted under this sub-
paragraph may not reduce a fee schedule amount pursu-
VerDate Aug 31 2005 
00:23 May 14, 2006
Jkt 049196
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H5369.IH
H5369
ccoleman on PROD1PC71 with BILLS