1.Short title;
table of contents
(a)This Act may be cited
as the Medicare Clinical Diagnostic Laboratory Fee Schedule
Modernization Act of 2009
.
(b)The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
Title I—Updating the Clinical Laboratory Fee Schedule
Sec. 101. Findings and purpose.
Sec. 102. Process for the modernization of the fee schedule for
clinical diagnostic laboratory tests.
Sec. 103. Establishment and duties of negotiated rulemaking
committee.
Sec. 104. Result of committee action.
Sec. 105. Report by MedPAC.
Sec. 106. Definitions.
Title II—Updating the Specimen Collection Fee
Sec. 201. Adjustment in Medicare laboratory specimen collection
fee.
<enum>I</enum><header>Updating the
Clinical Laboratory Fee Schedule</header>
<section id="HD05F398358EF4D6EB19F7D3E3F63FBA6"><enum>101.</enum><header>Findings and
purpose</header>
<subsection id="HDFB63C980E61488D87F9AA38049258DC"><enum>(a)</enum><header>Findings</header><text>The
Congress finds the following:</text>
<paragraph id="HD158D49384B74970824651FF78A62441"><enum>(1)</enum><text>The fee schedule
for clinical diagnostic laboratory tests under part B of the Medicare program
was developed in 1984 based on the local prevailing fees charged in
1983.</text>
</paragraph><paragraph id="HAAB007A3A08948E18429FE106317C83"><enum>(2)</enum><text>The cost of
clinical diagnostic laboratory tests, laboratory equipment, supplies, and
medical professional staff has increased exponentially in recent years.</text>
</paragraph><paragraph id="H000D16911879421A858E1B3F20B0861B"><enum>(3)</enum><text>Clinical
laboratories are currently reimbursed at levels below those provided in 1984
when adjusted for inflation.</text>
</paragraph><paragraph id="H088484B95D3E43CCB684131725445FE3"><enum>(4)</enum><text>The fee schedule
for clinical diagnostic laboratory tests is the last Medicare fee schedule that
has not been made reliant on prospective payment or relative value as the
primary payment methodology.</text>
</paragraph><paragraph id="H1F3964CD28EF4FC1BD19A052B2FEE4D"><enum>(5)</enum><text>Clinical
laboratories provide vital information that influences 70 percent of all
patient care decisions.</text>
</paragraph></subsection><subsection id="H3075A84977A74C63B15854BE298975B1"><enum>(b)</enum><header>Purpose</header><text>The
purpose of this Act is—</text>
<paragraph id="H9FD20B9B9D3E4ACD8E4401F901CA908D"><enum>(1)</enum><text>to ensure Medicare
beneficiary access to the best laboratory services and most advanced testing
available;</text>
</paragraph><paragraph id="H695100F4F77B43D980F03CC9D1C1D300"><enum>(2)</enum><text>to modernize the
fee schedule for clinical diagnostic laboratory tests under part B of the
Medicare program to reflect the increased cost and enhanced technology involved
in laboratory testing and to reflect accurately and equitably the value of such
testing to the health care system;</text>
</paragraph><paragraph id="HFACFB22F1F8040489D2E17B760249569"><enum>(3)</enum><text>to involve
relevant stakeholders in the clinical laboratory industry in the process of
such fee schedule modernization, including Medicare beneficiaries, health care
providers, and laboratories; and</text>
</paragraph><paragraph id="HD3F37BD080474E70B5537FD1BBE2C41E"><enum>(4)</enum><text>to create
mechanisms for periodic revisions, inflationary updates, and inclusion of new
methodologies to the fee schedule for clinical diagnostic laboratory tests in
order to reflect market conditions.</text>
</paragraph></subsection></section><section id="H2963F61656744357BE0196A71B134864"><enum>102.</enum><header>Process for the
modernization of the fee schedule for clinical diagnostic laboratory
tests</header>
<subsection id="H365D43C59321479EA6A9D3E08753002E"><enum>(a)</enum><header>In
general</header><text>Pursuant to the provisions of this title and consistent
with the elements described in subsection (b), the Secretary of Health and
Human Services shall—</text>
<paragraph id="HA73DD27E43C54530B06E6300A3BAC229"><enum>(1)</enum><text>establish under
section 103(a) a negotiated rulemaking committee to negotiate and develop a
proposed rule for a Medicare modernized clinical diagnostic laboratory fee
schedule (as defined in section 106(3));</text>
</paragraph><paragraph id="H956CE4231F1A485ABDAF807B158EBB42"><enum>(2)</enum><text>not later than 24
months after the date of the enactment of this Act and pursuant to such
negotiated rulemaking process, submit to Congress a report under section
103(f)(2)(B) relating to such Medicare modernized clinical diagnostic fee
schedule; and</text>
</paragraph><paragraph id="H3B1848838520461A9922CB9BB88DC203"><enum>(3)</enum><text>promulgate under
section 104 final regulations establishing such Medicare modernized clinical
diagnostic fee schedule if the Committee reaches consensus.</text>
</paragraph></subsection><subsection id="H380A58822FC547E396CE799E7E435644"><enum>(b)</enum><header>Elements</header>
<paragraph id="HDA540C076C9148AF8936644140DD7E10"><enum>(1)</enum><header>Elements for
inclusion</header><text>The negotiated rulemaking committee established under
section 103 shall consider the following elements and include them in the
proposed rule for a Medicare modernized clinical diagnostic laboratory fee
schedule:</text>
<subparagraph id="HC36C990C0F874694897C50FAF4D064A7"><enum>(A)</enum><text>Access, to the
greatest extent possible, by all individuals enrolled in part B of title XVIII
of the Social Security Act to quality laboratory services in all
settings.</text>
</subparagraph><subparagraph id="HE5272143870A4951AA5D302491E99D05"><enum>(B)</enum><text>Establishment of a
single, rational, and national fee schedule for clinical diagnostic laboratory
tests.</text>
</subparagraph><subparagraph id="H5D8238673EBD44F4A68132B7A03F00F8"><enum>(C)</enum><text>A mechanism to
periodically revise the fee schedule for years subsequent to the first year in
which the fee schedule is implemented that includes the following
components:</text>
<clause id="H6B38F6E4078A43B6A8A9F7B73073CFE7"><enum>(i)</enum><text display-inline="yes-display-inline">The mechanism is sufficiently adaptable to
incorporate new clinical laboratory tests and technology into the fee schedule
in a timely manner and to provide appropriate reimbursement for these
tests.</text>
</clause><clause id="H0146B9B432354809AC30008BB9349F05"><enum>(ii)</enum><text>The
mechanism periodically and appropriately revises clinical laboratory
reimbursement to reflect the evolution of costs, value, and utilization of such
tests.</text>
</clause><clause id="H6E39D80917F14FA8BA4208D6C94B7E4C"><enum>(iii)</enum><text>The mechanism is
not based on an arbitrary cap.</text>
</clause><clause id="HD5C24D2503F34E2E99E9473058BF12DD"><enum>(iv)</enum><text>The
mechanism provides for revisions to the fee schedule at least once every five
years, but not more frequently than annually.</text>
</clause><clause id="H3CBEA37F23354BB3A824D362C8726F59"><enum>(v)</enum><text>The
mechanism provides for input from relevant stakeholders, including patients,
health care providers, and clinical laboratories.</text>
</clause></subparagraph><subparagraph id="H75A8240683D84EBB869298B625B5859C"><enum>(D)</enum><text>For the first year
for which the fee schedule is implemented, the fee schedule shall be designed
to result in the same amount of aggregate payments under such schedule for
clinical laboratory services furnished during such year for which payment is
made under part B of title XVIII of the Social Security Act as would have been
made under section 1833(h) of such Act for such services if this section had
not been enacted (taking into account annual adjustments under paragraph (2) of
such section, the annual addition of new tests under paragraph (8) of such
section, and any other utilization increases that would have been recognized
under such section).</text>
</subparagraph><subparagraph id="H24F5DCE535704A7E8C2C5DEA409564A3"><enum>(E)</enum><text>A mechanism to
provide for automatic annual inflationary updates to the fee schedule for each
year after the first year for which the fee schedule is implemented.</text>
</subparagraph><subparagraph id="HE7C94D53B3804028A8F02FF49CD0906"><enum>(F)</enum><text>A transition period
to phase in the application of the payment rates under the fee schedule based
on blended payment rates between such fee schedule and the fee schedule in
effect on the day before the date of the enactment of this Act under section
1833(h) of the Social Security Act for clinical laboratory services, which is
to be provided in an efficient and fair manner.</text>
</subparagraph><subparagraph id="H26485A25D1F04D8994FDB8D103E76D01"><enum>(G)</enum><text>A fee schedule
that does not utilize beneficiary cost sharing.</text>
</subparagraph></paragraph><paragraph id="HF4A14EB2690A480AA0246F6296594879"><enum>(2)</enum><header>Elements for
consideration</header><text>Such negotiated rulemaking committee shall consider
whether to include the following elements in the Medicare modernized clinical
diagnostic laboratory fee schedule:</text>
<subparagraph id="HB17348F8E3A34125A86FB78FE22D5100"><enum>(A)</enum><text>A fee schedule
that provides for greater administrative simplicity and efficiency by
eliminating or reducing the number of differential payment rates in existence
on the day before the date of the enactment of this Act under section 1833(h)
of the Social Security Act for clinical diagnostic laboratory tests.</text>
</subparagraph><subparagraph id="HA6695224AEB840A8A490DBEF82999300"><enum>(B)</enum><text>A fee schedule
that addresses the unique reimbursement problems laboratories face as indirect
providers, including requirements that laboratories must rely on diagnosis
codes provided by ordering providers.</text>
</subparagraph></paragraph></subsection></section><section id="H3018D34F81C9435D83E3C569A6D89900"><enum>103.</enum><header>Establishment
and duties of negotiated rulemaking committee</header>
<subsection id="H08540EAD8C2841A188266DA193C9F22C"><enum>(a)</enum><header>Establishment</header><text>Not
later than 30 days after the date of the enactment of this Act, the Secretary
shall publish a notice in the Federal Register of intent to establish a
negotiated rulemaking committee (in this title referred to as the
<quote>Committee</quote>) in accordance with subchapter III of chapter 5 of
title 5, United States Code (5 U.S.C. 561 et seq.) and this section to
negotiate and develop a proposed rule for a Medicare modernized clinical
diagnostic laboratory fee schedule (as defined in section 106(3)). Not later
than 60 days after the day on which such notice of intent is published, the
Secretary shall appoint members to the Committee in accordance with subsection
(b).</text>
</subsection><subsection id="H039575E55094478F988D7EFABC288660"><enum>(b)</enum><header>Composition of
committee</header>
<paragraph id="HB3D487CF6C1B4FBF9709CD94A9868B89"><enum>(1)</enum><header>In
general</header><text>Notwithstanding section 565(b) of title 5, United States
Code, the Committee shall be composed of 19 voting members appointed pursuant
to paragraph (2) and 2 nonvoting members appointed pursuant to paragraph
(3).</text>
</paragraph><paragraph id="H68FD6A23600C4A42B668EA4819612EB7"><enum>(2)</enum><header>Voting
members</header><text>The Secretary shall appoint as voting members of the
Committee individuals as follows:</text>
<subparagraph id="HA73EF88BA80C41CDB1DE7FB23FAE5E3E"><enum>(A)</enum><text>One individual
from an organization primarily representing independent clinical laboratories
operating on a national basis.</text>
</subparagraph><subparagraph id="H5072092B650D43618FE5E44C20E8D0FF"><enum>(B)</enum><text display-inline="yes-display-inline">One individual from an organization
primarily representing independent clinical laboratories operating on a
regional or local basis.</text>
</subparagraph><subparagraph id="H12DB820681E74AB399A309B4131330FE"><enum>(C)</enum><text display-inline="yes-display-inline">One individual from an organization
representing hospitals that perform clinical diagnostic laboratory
tests.</text>
</subparagraph><subparagraph id="HBA9C2641F70D41629B75CA86B2E32BC1"><enum>(D)</enum><text>Two individuals
from organizations representing physicians with expertise in clinical
diagnostic laboratory tests.</text>
</subparagraph><subparagraph id="HCF6AC187431E49E1A317E3D02EFB418D"><enum>(E)</enum><text>Three individuals
from organizations representing non-physicians with expertise in clinical
diagnostic laboratory tests.</text>
</subparagraph><subparagraph id="HC66E7B6D788942E6A232CF2B00936B8"><enum>(F)</enum><text display-inline="yes-display-inline">One individual from an organization
representing manufacturers of equipment designed for clinical diagnostic
laboratory tests.</text>
</subparagraph><subparagraph id="H81ACD8A30F62478FBB5292E3F716E3D"><enum>(G)</enum><text display-inline="yes-display-inline">One individual from an organization
representing individuals enrolled under part B of title XVIII of the Social
Security Act.</text>
</subparagraph><subparagraph id="H891B6F2F910B4478BCEF4139996CCB2E"><enum>(H)</enum><text display-inline="yes-display-inline">One individual from an organization
representing private payers for clinical diagnostic laboratory tests.</text>
</subparagraph><subparagraph id="H8375D40B9A3348A0BA78BBED5196A500"><enum>(I)</enum><text>One individual
with expertise in measuring resource utilization by clinical diagnostic
laboratories in performing tests.</text>
</subparagraph><subparagraph id="HE1384433EB7C4118A79C36A3854ECFF5"><enum>(J)</enum><text>One individual
with a background in health economics and the ability to quantify the value of
clinical diagnostic laboratory tests.</text>
</subparagraph><subparagraph id="H345B5D339E904F4381AC838E46F27CF6"><enum>(K)</enum><text>Two individuals
from organizations representing generalist non-physicians with expertise in
clinical diagnostic laboratory tests.</text>
</subparagraph><subparagraph id="HF8EED2F24EF741F09F36A4D9A413022"><enum>(L)</enum><text>One individual who
is a physician or clinician who prescribes clinical diagnostic laboratory
tests.</text>
</subparagraph><subparagraph id="H6089A2210A374D3A98ED4C5D007B526C"><enum>(M)</enum><text>One individual who
is a physician or clinician who performs point-of-care tests in the physician’s
or clinician’s office.</text>
</subparagraph><subparagraph id="H23AE45EB5EB141D4AE9FCBA03A345C"><enum>(N)</enum><text display-inline="yes-display-inline">One individual from an organization
representing individuals with scientific background and experience in clinical
laboratory health care services.</text>
</subparagraph><subparagraph id="H3ED5348186EE45AE96645175386E1D56"><enum>(O)</enum><text display-inline="yes-display-inline">One individual from an organization
representing managers or supervisors of clinical laboratories.</text>
</subparagraph></paragraph><paragraph id="H34F0182F309F4F7892009E86E8242B6E"><enum>(3)</enum><header>Nonvoting
members</header><text>The Secretary shall appoint one nonvoting member to the
Committee. The Chairman of the Medicare Payment Advisory Commission shall
appoint one nonvoting member to the Committee.</text>
</paragraph></subsection><subsection id="H479E5D2695FD4F3A9184200015A04698"><enum>(c)</enum><header>Duties of
committee</header><text>The Committee shall negotiate and attempt to reach a
consensus (as defined in section 562(2) of title 5, United States Code)
concerning a proposed rule with respect to establishing a Medicare modernized
clinical diagnostic laboratory fee schedule and any other matter the committee
determines is relevant to the proposed rule. In its negotiations, the Committee
shall take into account the purpose described in section 101(b), the elements
listed in section 102(b), and the input of relevant stakeholders.</text>
</subsection><subsection id="HE1753ADA087E4A7E9195FA3D943A306"><enum>(d)</enum><header>Term;
vacancies</header>
<paragraph id="H1C735576BFF2451282143F6EBDD633E"><enum>(1)</enum><header>Term</header><text>Each
member of the Committee shall be appointed for the life of the
Committee.</text>
</paragraph><paragraph id="H3E83DCD0DC7C4217B3FAE630CF0050E5"><enum>(2)</enum><header>Vacancies</header><text>A
vacancy on the Committee shall be filled in the same manner in which the
original appointment was made.</text>
</paragraph></subsection><subsection id="H8D58AB314C14489F94ABBF9EE8A29F02"><enum>(e)</enum><header>Administrative
provisions</header>
<paragraph id="H550C39E4A5E849B9B2FDD06FC83C4D1E"><enum>(1)</enum><header>Quorum</header><text>A
quorum shall be required to conduct the business of the Committee. Twelve
members of the Committee shall constitute a quorum.</text>
</paragraph><paragraph id="H3CF681F9795C4424946928B6AECC90A6"><enum>(2)</enum><header>Meetings</header><text>The
Committee shall meet at the call of the Facilitator (as chosen under section
566(c) of title 5, United States Code), the Secretary, or a quorum of the
members of the Committee.</text>
</paragraph><paragraph id="HDD3E0D554C1B462A912B4C50555FB32D"><enum>(3)</enum><header>Compensation</header><text>The
members of the Committee may be compensated in accordance with section 568(c)
of title 5, United States Code.</text>
</paragraph><paragraph id="HE544D14A75744DE2964562FDB665AA58"><enum>(4)</enum><header>Staffing</header>
<subparagraph id="HE17C8C54F50A43B198964E17339BBC1"><enum>(A)</enum><header>Detailing</header><text>Any
Federal Government employee may be detailed to the Committee without
reimbursement from the Committee, and such detailee shall retain the rights,
status, and privileges of their regular employment without interruption.</text>
</subparagraph><subparagraph id="HEBADE335804C4273810492A0F2673E32"><enum>(B)</enum><header>Technical
assistance</header><text>If authorized by the Secretary and approved by a
majority of the Committee, the Committee may retain the services of experts and
consultants under section 3109(b) of title 5, United States Code, but at rates
not to exceed the daily equivalent of the annual rate of basic pay for level IV
of the Executive Schedule under section 5315 of such title.</text>
</subparagraph></paragraph><paragraph id="H82564F123994426C989D3E65E3E74EF1"><enum>(5)</enum><header>Applicability of
FACA</header><text>The Federal Advisory Committee Act (5 U.S.C. App.) shall
apply to the Committee in accordance with section 565(a)(1) of title 5, United
States Code.</text>
</paragraph></subsection><subsection id="H7EC972B4DBA74B990024F4338445788"><enum>(f)</enum><header>Reports</header>
<paragraph id="HD7D4991CD3FA4838A3816EC4EC1C0999"><enum>(1)</enum><header>Committee
reports</header>
<subparagraph id="H41C430B1B32F4218AEB780F35E545ED"><enum>(A)</enum><header>Interim
reports</header>
<clause id="H89F9A57D948246998D048D12AA2EB5C6"><enum>(i)</enum><header>Initial interim
report</header><text display-inline="yes-display-inline">Not later than 6
months after the date on which members are required to be appointed to the
Committee under subsection (a), the Committee shall submit to the Secretary an
initial interim report on the Committee’s progress in negotiating a proposed
rule to establish a Medicare modernized clinical diagnostic laboratory fee
schedule, including the Committee’s preliminary determinations regarding the
establishment of such fee schedule and including preliminary determinations on
the information described in subparagraph (B).</text>
</clause><clause id="HB85E99B029314399006EF184E07BD0E7"><enum>(ii)</enum><header>Subsequent
interim report</header><text>The Committee shall submit to the Secretary a
subsequent interim report, which shall include updates to the determinations
made in the report submitted under clause (i). Such subsequent interim report
shall be submitted not later than 12 months after the date on which members are
required to be appointed to the Committee under subsection (a).</text>
</clause><clause id="H2C1B14115CB245F3B2515674FBF20959"><enum>(iii)</enum><header>Exception</header><text>An
interim report described in this subparagraph is not required to be submitted
in the case that a final report under subparagraph (B) is submitted before the
date on which such interim report is required to be submitted under this
subparagraph.</text>
</clause></subparagraph><subparagraph id="H53BE6D6FD4554ADDB900EDF8D31F7CF"><enum>(B)</enum><header>Final
report</header><text>Not later than 18 months after the date on which members
are required to be appointed to the Committee under subsection (a), the
Committee shall submit to the Secretary a final report, including the
following:</text>
<clause id="H94A80B12A1A8437DA8E0AF2BDB2352C1"><enum>(i)</enum><text>If
the Committee reaches consensus by such 18-month date on a proposed rule to
establish a Medicare modernized clinical diagnostic laboratory fee
schedule—</text>
<subclause id="H253264897AE042CF84BC5429EC02989D"><enum>(I)</enum><text>the consensus
proposed rule reached by the Committee; and</text>
</subclause><subclause id="HA68000E685794C85A981C636A0C9DAE"><enum>(II)</enum><text>the Committee’s
determination regarding the extent to which, and manner in which, the proposed
fee schedule will achieve the purpose described in section 101(b) and address
the elements described in section 102(b).</text>
</subclause></clause><clause id="H277D7DFD49F2425F95FFC5DAC3DF7704"><enum>(ii)</enum><text>If
the Committee fails to reach consensus by such 18-month date on a proposed rule
to establish a Medicare modernized clinical diagnostic laboratory fee
schedule—</text>
<subclause id="H5D430BCF126443FF89FF6CB443DB596C"><enum>(I)</enum><text>any components of
a fee schedule or other areas upon which consensus was achieved in accordance
with the purpose described in section 101(b) and the elements described in
section 102(b); and</text>
</subclause><subclause id="HE962E9EB7DB645D99683BF3DCC785479"><enum>(II)</enum><text>any components of
a fee schedule or other areas upon which disagreement prevented consensus from
being achieved in accordance with the purpose described in section 101(b) and
the elements described in section 102(b).</text>
</subclause></clause></subparagraph></paragraph><paragraph id="H5D4CAAA4198045CB9EB1268CE61F3BB7"><enum>(2)</enum><header>Secretarial
reports</header>
<subparagraph id="H0949EFDD03CE4BE680BBFEE98E83BC9F"><enum>(A)</enum><header>Interim
reports</header><text>Not later than 30 days after the date of the submission
of each interim report under paragraph (1)(A), the Secretary shall submit to
the Committee on Energy and Commerce and the Committee on Ways and Means of the
House of Representatives and the Committee on Finance of the Senate an interim
report on the progress of the negotiated rulemaking process under this section
to establish a Medicare modernized clinical diagnostic laboratory fee schedule.
Each such report shall include the corresponding interim report submitted by
the Committee under such paragraph.</text>
</subparagraph><subparagraph id="H9512674E91BE45679E8C31BD92CCE551"><enum>(B)</enum><header>Final
report</header><text>Not later 24 months after the date of the enactment of
this Act, the Secretary shall submit to the Committee on Energy and Commerce
and the Committee on Ways and Means of the House of Representatives and the
Committee on Finance of the Senate a final report, including—</text>
<clause id="H5FD506F495F54EF3BADB20DE7B001159"><enum>(i)</enum><text>the
final report of the Committee submitted under paragraph (1)(B); and</text>
</clause><clause id="H52836DC6110244909616DCC3B892045D"><enum>(ii)</enum><text>in
the case that the Committee reaches a consensus on a proposed rule to establish
a Medicare modernized clinical diagnostic laboratory fee schedule, the
Secretary’s proposed regulation to implement the proposed rule.</text>
</clause></subparagraph></paragraph><paragraph id="H4154508BFB504CD300BD7B241D2BB800"><enum>(3)</enum><header>Public
availability of reports</header><text>The Secretary shall make each report
submitted under this subsection available to the public on the official
Internet website of the Department of Health and Human Services.</text>
</paragraph></subsection></section><section id="H4E65335A87304299BA1BF21E6D8D3562"><enum>104.</enum><header>Result of
committee action</header>
<subsection id="H902BCFB54A5040A492417DBD476EC66B"><enum>(a)</enum><header>Committee
consensus</header><text>If the Committee reaches a consensus under section 103
on a proposed rule to establish a Medicare modernized clinical diagnostic
laboratory fee schedule, the Secretary shall, to the maximum extent possible
consistent with the legal obligations of the agency, use the consensus of the
Committee as the basis for the rule proposed by the agency for notice and
comment and, not later than 36 months after the date of the enactment of this
Act, issue final regulations to apply to items and services furnished on or
after the first January 1st following the date of the promulgation of such
final regulations.</text>
</subsection><subsection id="HF67A8C9E9DC2426A9C3B2C5357308EE5"><enum>(b)</enum><header>Lack of
committee consensus</header><text>If the Committee fails to reach a consensus
under section 103 on a proposed rule to establish a Medicare modernized
clinical diagnostic laboratory fee schedule, authority remains with the
Congress to establish such fee schedule, taking into account the purpose
described in section 101(b) and the elements described in section 102(b) and
the report provided by the Medicare Payment Advisory Commission under section
105(2).</text>
</subsection></section><section id="HEA8747ED5A4A40BEB9BD90003184A248"><enum>105.</enum><header>Report by
MedPAC</header><text display-inline="no-display-inline">Not later than 39
months after the date of the enactment of this Act, the Medicare Payment
Advisory Commission shall submit to Congress a report, including the following
recommendations:</text>
<paragraph id="HF6589C6F7DE54681B1C83D808F23A150"><enum>(1)</enum><header>Committee
consensus</header><text>In the case that the Committee reaches consensus under
section 103 on a proposed rule to establish a Medicare modernized clinical
diagnostic laboratory fee schedule, with respect to the Secretary’s proposed
regulation submitted under section 103(f)(2)(B)(ii) to implement such proposed
rule—</text>
<subparagraph id="H458E25DA7FF54302A696511B509FE91"><enum>(A)</enum><text>whether the overall
level of expenditures under title XVIII of the Social Security Act for clinical
laboratory services under the revised fee schedule under such proposed
regulation is adequate to ensure beneficiary access to high quality testing;
and</text>
</subparagraph><subparagraph id="H6F0BCE763C7D4D17881CF3A4400F73C"><enum>(B)</enum><text>whether the
periodic revision and inflationary update mechanisms in the proposed regulation
are adequate to ensure beneficiary access to high quality testing.</text>
</subparagraph></paragraph><paragraph id="H86909ED208994BECBAAFBD27427B2225"><enum>(2)</enum><header>Lack of
committee consensus</header><text>In the case that the Committee does not reach
consensus under section 103 on a proposed rule to establish a Medicare
modernized clinical diagnostic laboratory fee schedule—</text>
<subparagraph id="HCC93A825D66D4EAD98D191A760C5A799"><enum>(A)</enum><text>how to modernize
such clinical laboratory fee schedule in accordance with the purpose described
in section 101(b) and the elements described in section 102(b), including with
respect to such areas identified in the report submitted under section
103(f)(1)(B)(ii) as areas in which consensus was not reached by the
Committee;</text>
</subparagraph><subparagraph id="H431B7456C7D04698B0D9CF40C45BE5D1"><enum>(B)</enum><text>how to ensure the
overall level of expenditures under part B of title XVIII of such Act for
clinical laboratory services under a revised fee schedule is adequate to ensure
beneficiary access to high quality testing; and</text>
</subparagraph><subparagraph id="H1755F70BCEE04CF7915E5DD44412E463"><enum>(C)</enum><text>how to ensure that
periodic revision and inflationary update mechanisms in a proposed revised fee
schedule for clinical laboratory services are adequate to ensure beneficiary
access to high quality testing.</text>
</subparagraph></paragraph></section><section id="H6BC6804346DB42C8BF17626BBCF1368C"><enum>106.</enum><header>Definitions</header><text display-inline="no-display-inline">For purposes of this title:</text>
<paragraph id="H7D61A76318DD4E0D812BF0F7BA517336"><enum>(1)</enum><header>Committee</header><text>The
term <term>Committee</term> means the negotiated rulemaking committee
established under section 103(a).</text>
</paragraph><paragraph id="H1A5A7C3ED76644C6B42D88479350AD19"><enum>(2)</enum><header>Consensus</header><text>The
term <term>consensus</term> has the meaning given such term under section
562(2) of title 5, United States Code.</text>
</paragraph><paragraph id="H35D8147FFF43458C9805AEFE6BA86EB5"><enum>(3)</enum><header>Medicare
modernized clinical diagnostic laboratory fee schedule</header><text>The term
<term>Medicare modernized clinical diagnostic laboratory fee schedule</term>
means a modernized fee schedule for payment under part B of title XVIII of the
Social Security Act for clinical diagnostic laboratory tests, the payment for
which, as of the day before the date of the enactment of this Act, is provided
for under section 1833(h) of the Social Security Act (42 U.S.C.
1395l(h)).</text>
</paragraph><paragraph id="HF77149C6C0A24AA694EC359EA8071116"><enum>(4)</enum><header>Negotiated
rulemaking</header><text>The term <term>negotiated rulemaking</term> has the
meaning given such term under section 562(6) of title 5, United States
Code.</text>
</paragraph><paragraph id="H321165012A6F4B51BC34FD2B82D2BD56"><enum>(5)</enum><header>Negotiated
rulemaking committee</header><text>The term <term>negotiated rulemaking
committee</term> has the meaning given such term under section 562(7) of title
5, United States Code.</text>
</paragraph><paragraph id="HAC26C36B61AE46DA8732D968412E305B"><enum>(6)</enum><header>Secretary</header><text>The
term <term>Secretary</term> means the Secretary of Health and Human
Services.</text>
</paragraph></section><enum>II</enum><header>Updating the
Specimen Collection Fee</header>
<section id="H18BE338790924D93BEEE79B5888E85DD"><enum>201.</enum><header>Adjustment in
Medicare laboratory specimen collection fee</header>
<subsection id="H7DF4E116AC504EED97B784092CC983EA"><enum>(a)</enum><header>In
general</header><text>Section 1833(h) of the Social Security Act (42 U.S.C.
1395l(h)) is amended—</text>
<paragraph id="H765A09D8215B44DAAF75D362F907EEB8"><enum>(1)</enum><text>in paragraph
(3)(A), by inserting <quote>in the amount specified in paragraph (8)</quote>
after <quote>a nominal fee</quote>; and</text>
</paragraph><paragraph id="H951521B20FDD4F55A7C88BA4716E4C90"><enum>(2)</enum><text>by adding at the
end the following new paragraph:</text>
<quoted-block id="HAA58298EC5784A91A7DFBC00CCCF31E" style="OLC">
<paragraph id="H9A4F42054383486B9C54F19DEA0B67E"><enum>(8)</enum><text>The amount
specified in this paragraph, for the nominal fee under paragraph (3)(A) for
tests performed in—</text>
<subparagraph id="HAA75C323BDD9479985AB68E8673D4203"><enum>(A)</enum><text>2010, is $6.04;
or</text>
</subparagraph><subparagraph id="H07807148EA3A4C8C83EAD148F145FB46"><enum>(B)</enum><text>a subsequent year,
is the amount specified in this paragraph for tests performed in the preceding
year adjusted by the annual percentage increase or decrease in the Consumer
Price Index for All Urban Consumers (United States city
average).</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H38120A61D1D14C49B15693418FB669E0"><enum>(b)</enum><header>Effective
date</header><text>The amendments made by subsection (a) shall apply to fees
for tests performed on or after January 1, 2010.</text>
</subsection></section>