section 1886(d) of such Act (42 U.S.C. 
1395ww(d)) by reason of paragraph (5)(K) of 
such section, or that would have been so eligible 
on such date but for a local coverage deter-
mination that limits or denies coverage of and 
such additional payment for the item or service. 
(3) REVISION TO THE COST THRESHOLD.— 
(A) 
IN
GENERAL.—Section 
1886(d)(5)(K)(ii)(I) of the Social Security Act 
(42 U.S.C. 1395ww(d)(5)(K)(ii)(I)) is amended 
by striking ‘‘75 percent’’ each place it appears 
and inserting ‘‘50 percent’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by subparagraph (A) shall take effect on 
the date of the enactment of this Act. 
(4) USE OF BEST AVAILABLE COST DATA FOR 
MS–DRG CLASSIFICATION.— 
(A) IN GENERAL.—Section 1886(d)(5)(K) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395ww(d)(5)(K)), as amended by paragraph 
(2)(A), is further amended by adding at the end 
the following new clause: 
‘‘(xi) In carrying out the requirement 
under clause (ii)(IV) for classification of a 
new medical service or technology to a new 
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or existing diagnosis-related group after 
the close of the period under clause (ii)(II), 
the Secretary shall use the most recently 
available data and information on the costs 
of such service or technology in making 
such a classification for the service or tech-
nology, including data and information 
from surveys of providers of services and 
suppliers conducted by the Secretary, pri-
vate payers, health plans, physician spe-
cialty societies, or manufacturers as well as 
commercial price data and data from man-
ufacturer invoices.’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by subparagraph (A) shall take effect on 
the date of the enactment of this Act. 
(5) CRITERIA APPLIED IN MAKING SUBSTAN-
TIAL IMPROVEMENT DETERMINATIONS.— 
(A) IN GENERAL.—Section 1886(d)(5)(K) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395ww(d)(5)(K)), as amended by paragraphs 
(2)(A) and (4)(A), is further amended by add-
ing at the end the following new clause: 
‘‘(xii)(I) In making a determination 
under this subparagraph whether a new 
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medical service or technology represents an 
advance in medical technology that sub-
stantially improves the diagnosis or treat-
ment of Medicare beneficiaries relative to a 
medical service or technology that was pre-
viously available, the Secretary shall also 
consider whether such new medical service 
or technology meets one or more of the fol-
lowing criteria: 
‘‘(aa) The use of the new medical 
service or technology can result in a 
reduction of the length of a hospital 
stay. 
‘‘(bb) The use of the new medical 
service or technology can improve pa-
tient quality of life. 
‘‘(cc) The use of the new medical 
service or technology can create long- 
term clinical efficiencies in treatment. 
‘‘(dd) The use of the new medical 
service or technology can address pa-
tient-centered objectives (as defined 
by the Secretary). 
‘‘(ee) The use of the new medical 
service or technology decreases the 
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number of hospitalizations or physi-
cian visits. 
‘‘(ff) The use of the new medical 
service or technology reduces recovery 
time compared to the technologies 
previously used. 
‘‘(gg) The use of the new medical 
service or technology reduces device- 
related complications. 
‘‘(hh) The use of the new medical 
service or technology can result in de-
creased rate of subsequent diagnostic 
or therapeutic interventions (such as 
due to the reduced rate of recurrence 
of the disease process). 
‘‘(ii) The use of the new medical 
service or technology can result in 
more rapid beneficial resolution of the 
disease process treatment. 
‘‘(jj) The use of the new medical 
service or technology can result in de-
creased pain, bleeding, or other quan-
tifiable symptom. 
‘‘(kk) The use of the new medical 
service or technology can meet such 
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other criteria as the Secretary may 
specify. 
‘‘(II) In considering whether a new 
medical service or technology potentially 
meets the criteria under subclause (I), the 
Secretary shall consider the following 
forms of evidence: 
‘‘(aa) Evidence described in well- 
documented case histories, including 
registry data. 
‘‘(bb) Studies published in peer- 
reviewed journals. 
‘‘(cc) Data collected in countries 
other than the United States so long 
as such data otherwise meet the cri-
teria specified in this clause.’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by subparagraph (A) shall take effect on 
the date of the enactment of this Act. 
(6) REVISION TO THE NEWNESS CRITERION.— 
(A) 
IN
GENERAL.—Section 
1886(d)(5)(K)(vi) of the Social Security Act 
(42 U.S.C. 1395ww(d)(5)(K)(vi)) is amended— 
(i) by inserting ‘‘(I)’’ after ‘‘(vi)’’; and 
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(ii) by adding at the end the following 
new subclauses: 
‘‘(II) Under the criteria estab-
lished under this clause with respect 
to the determination of whether a 
medical service or technology is con-
sidered new for purposes of this sub-
paragraph and subparagraph (L), the 
Secretary shall include devices that in-
volve 
a 
significant 
technological 
change that do not raise different 
questions of safety and effectiveness 
(in a comparison to the predicate de-
vice) and result in enhanced clinical 
advantages or reduced cost, even 
though they use the same or similar 
mechanism of action or are assigned 
to the same diagnosis-related group. 
‘‘(III) Under the criteria estab-
lished under this clause with respect 
to the determination of whether a 
medical service or technology is con-
sidered new for purposes of this sub-
paragraph and subparagraph (L), the 
Secretary shall not disqualify a new 
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