submitted on or after such date, without regard to whether 
final regulations to carry out such amendment have been 
issued. 
SEC. 102. ISSUANCE OF REGULATIONS ON GAP-FILLING 
FOR MEDICARE FEE SCHEDULE FOR CLIN-
ICAL DIAGNOSTIC LABORATORY TESTS. 
Not later than one year after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services shall issue final regulations specifying how an ap-
propriate medicare administrative contractor (as defined 
in section 1874A(a)(3)(B) of the Social Security Act (42 
U.S.C. 1395kk–1(a)(3)(B)) shall apply a gap-filling meth-
odology in determining fee schedule amounts established 
under section 1833(h)(2)(A)(i) of such Act (42 U.S.C. 
1395l(h)(2)(A)(i)). Such regulations shall specify— 
(1) a process for ensuring that the resulting fee 
schedule amounts are fair, including a description of 
the types of data to be collected for use in such 
methodology and the minimum requirements such 
data shall meet in order to ensure that the data are 
valid, meaningful, and unbiased; 
(2) the principles to be employed to ensure that 
such data are statistically significant and alter-
natives to follow if statistically significant data are 
unavailable; 
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(3) the principles to be followed in using data 
to calculate fee schedule amounts, including prin-
ciples for excluding data that do not meet the re-
quirements of paragraph (1) and (2); 
(4) the methods the Secretary will use to over-
see the application of a gap filling methodology by 
such contractors and the remedies that will be avail-
able in cases in which such a contractor fails to com-
ply with regulatory requirements; and 
(5) a process that provides opportunities for the 
public to participate in the development of fee sched-
ule amounts through the application of gap-filling 
methodologies, including release to the public of data 
collection protocols and the data derived from such 
protocols with an opportunity for public comment 
thereon. 
SEC. 103. INCREASED TRANSPARENCY OF PROCESS FOR 
DETERMINING 
FEE 
SCHEDULE 
AMOUNTS 
FOR NEW TESTS. 
Section 1833(h)(8) of the Social Security Act (42 
U.S.C. 1395l(h)(8) is amended— 
(1) in subparagraph (B)(iii), by inserting ‘‘to be 
conducted in an inter-active format,’’ after ‘‘meet-
ing,’’; 
(2) in subparagraph (B)(iv)— 
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(A) by inserting ‘‘(I)’’ after ‘‘meeting,’’; 
(B) by striking ‘‘determination,’’ and in-
serting ‘‘determination and’’; and 
(C) by striking ‘‘a request for’’ and insert-
ing ‘‘(II) publishes in the Federal Register a 
notice of a period of not less than 60 days dur-
ing which the Secretary will receive’’; and 
(3) in subparagraph (C), by striking ‘‘Under 
the procedures’’ and inserting ‘‘In the regulations’’. 
SEC. 104. ADVANCE NOTICE OF CLINICAL DIAGNOSTIC LAB-
ORATORY TEST AMOUNTS BEING CONSID-
ERED FOR ADJUSTMENT UNDER INHERENT 
REASONABLENESS AUTHORITY. 
(a) LIMIT
ON INHERENT REASONABLENESS AU-
THORITY.—Section 1842(b)(9)(A) of the Social Security 
Act (42 U.S.C. 1395u(b)(9)(A)) is amended by adding at 
the end the following: ‘‘Before publishing a proposed no-
tice under subparagraph (B) with respect to any clinical 
diagnostic laboratory test being considered for adjustment 
under paragraph (8), advance notice that such test is 
being considered for such an adjustment shall be provided 
to non-governmental parties (as defined in section 
1833(h)(9)(A)(iv)) at the meeting required by section 
1833(h)(8)(B)(iii), together with an opportunity for such 
representatives and other individuals to make oral com-
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