109 HR 5369 IH: To amend title XVIII of the Social Security Act to
U.S. House of Representatives
2006-05-11
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.Short title and table of
contents
(a)This Act may be cited
as the Medicare Clinical Laboratory Fee Schedule Improvement Act of
2006
.
(b)The table of
contents of this Act is as follows:
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
authority.
Title II—Future Reform
Sec. 201. Establishment of medicare demonstration project to
evaluate new approaches to coding and payment for certain molecular diagnostic
tests.
<enum>I</enum><header>Near-Term
Changes</header>
<section id="H582328A8BD9C4EC88CCA523727933897"><enum>101.</enum><header>Fee schedule
and national limitation amounts for clinical diagnostic laboratory
tests</header>
<subsection id="HE625B557CDB84EE49CE642CE17366816"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 1833(h) of
the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(h)</external-xref>) is amended by adding at the end
the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="HDCC4DFA9D022431FA62454DE9439B02B" style="OLC">
<paragraph id="H091D47B5B7DF4E8A9C104B31FF74E401" indent="up1"><enum>(9)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HF5C49BF8F0354CDEBF6523B5506BBAC1"><enum>(A)</enum><text display-inline="yes-display-inline">For purposes of this paragraph:</text>
<clause id="HD7EA4F64F7D94A8EB3834F97B7496053" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">The term ‘an amount determined under this
subsection’ means, with respect to a clinical laboratory test, the fee schedule
amount determined under paragraph (2)(A)(i) for the test or the limitation
amount determined under paragraph (4)(B) for the test.</text>
</clause><clause id="H138FED628B4C41D9B904C5F300A3E736" indent="up1"><enum>(ii)</enum><text>The terms ‘appropriate medicare
administrative contractor’ and <quote>medicare administrative
contractor</quote> have the meaning given to such terms under section
1874A(a)(3).</text>
</clause><clause id="HB40050DABEFA48F1A47144903E5B7BE3" indent="up1"><enum>(iii)</enum><text>The term ‘erroneous decision’
means, with respect to the determination of an amount determined under this
subsection, any decision, calculation, 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 payment amount, except that such term does not include
typographical or clerical errors.</text>
</clause><clause id="HC9DDFB91DBF4410082A6652C4D6165AF" indent="up1"><enum>(iv)</enum><text>The term ‘non-governmental party’
includes—</text>
<subclause id="HC5104EB5820C4033887995C1B5E43781"><enum>(I)</enum><text display-inline="yes-display-inline">a provider of services (as defined in
section 1861(u)) that furnishes clinical diagnostic laboratory tests for which
payment may be made under this subsection;</text>
</subclause><subclause id="HB57CEC410488422399DF85EBD2409DE7"><enum>(II)</enum><text>a supplier (as defined in section
1861(d)) that furnishes such tests; and</text>
</subclause><subclause id="H58C9AC59F8AD4557B3DBAA0616575DA3"><enum>(III)</enum><text>a manufacturer of a test or of
any supplies or equipment that are used in performing such test.</text>
</subclause></clause></subparagraph><subparagraph id="H4D5CE2F11618489A96909BE83EC8A629" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">An amount determined under this subsection
may be changed solely on the basis of—</text>
<clause id="HEA334046395A4E07AC85DAD92B2539D3"><enum>(i)</enum><text display-inline="yes-display-inline">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 regulatory guidance implementing such provisions; or</text>
</clause><clause id="HFC4AED570DA445DCA667DFBA21A31BB9"><enum>(ii)</enum><text display-inline="yes-display-inline">in the case of a change to correct an erroneous decision in determining such an
amount, the authority provided by subparagraphs (C), (D), and (E).</text>
</clause></subparagraph><subparagraph id="H113132CA2793481A0062E568FD04B9D1" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">Any erroneous decision in determining an
amount under this subsection may be corrected only if—</text>
<clause id="H0A3102A892BC4EA4B8B3DFB7DCA8338"><enum>(i)</enum><text>a non-governmental party submits a
request under subparagraph (D) or (E) for correction of the erroneous decision;
and</text>
</clause><clause id="HA1EB23A541224BEDBE56E44E8773AF99"><enum>(ii)</enum><text>such party demonstrates, to an
appropriate medicare administrative contractor under subparagraph (D) or the
Secretary under subparagraph (E), that an erroneous decision clearly was
made.</text>
</clause></subparagraph><subparagraph id="HD2B3CACF736D4F30A6B4D87BCE486E05" indent="up1"><enum>(D)</enum><clause commented="no" display-inline="yes-display-inline" id="HACC4F9A507D74351BCD99523E955CE96"><enum>(i)</enum><text>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.</text>
</clause><clause id="H3ECFB674BD7141869CA618F1003EADEA" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">Any request under this subparagraph shall
include a statement of the basis for the non-governmental party’s belief that
an erroneous decision was made in determining such amount, together with
supporting evidence and a description of any additional data (other than data
already in the possession of the appropriate medicare administrative
contractor) that—</text>
<subclause id="H5E50696C42534A77A3A101A3BF545DDF"><enum>(I)</enum><text>is or may be in the possession of the
Secretary or another medicare administrative contractor; and</text>
</subclause><subclause id="H9ED16DA853F441049804F3BBDF16F07F"><enum>(II)</enum><text>is necessary to demonstrate that such
an erroneous decision exists.</text>
</subclause></clause><clause id="HB223A667BC864E259401002EEF63F000" indent="up1"><enum>(iii)</enum><text>If the Secretary or another
medicare administrative contractor is identified as possessing or potentially
possessing additional data identified by a non-governmental 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
appropriate safeguards to protect confidential and proprietary
information.</text>
</clause><clause id="H904943E802F844FDB8B90550BEFA8415" indent="up1"><enum>(iv)</enum><text display-inline="yes-display-inline">If additional data are made available to a
non-governmental party under clause (iii), such party may amend its request
under this subparagraph to incorporate such data within 30 days after the date
such data are made available to such party.</text>
</clause><clause id="HAD301A0DB01C49DF979FF5CD182FAC76" indent="up1"><enum>(v)</enum><text display-inline="yes-display-inline">An appropriate medicare administrative
contractor to which a request is submitted under this subparagraph shall make a
determination with respect to whether to correct the decision that is
identified as erroneous 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-governmental party submitting the request—</text>
<subclause id="H7BC6A988350042BDA3BA68770009AB35"><enum>(I)</enum><text display-inline="yes-display-inline">has demonstrated that an erroneous decision
clearly was made, correct such erroneous decision, 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</text>
</subclause><subclause id="H7DE75947E4FB416D8E10D033143B6241"><enum>(II)</enum><text>has failed to demonstrate that an
erroneous decision clearly was made and decline to change the fee schedule
amount,</text>
</subclause><continuation-text continuation-text-level="clause">and shall
provide to the non-governmental party a written explanation of the basis for
such determination.</continuation-text></clause><clause id="H31001A6AA4B643ADB487E20053B34D83" indent="up1"><enum>(vi)</enum><text display-inline="yes-display-inline">An appropriate medicare administrative
contractor to which a request is submitted under this subparagraph may not
reduce a fee schedule amount pursuant to such request, and may reduce such an
amount only pursuant to section 1842(b)(8).</text>
</clause></subparagraph><subparagraph id="H6CCAB0D9E2004214AD49D873B4BA7444" indent="up1"><enum>(E)</enum><clause commented="no" display-inline="yes-display-inline" id="H24333C262D6E4F9BA13180696C9F0493"><enum>(i)</enum><text>Any non-governmental
party may request (in such form and manner as the Secretary may require) that
the Secretary—</text>
<subclause id="H6F188AB1E5C04567BAC7A6B100A2FDFA" indent="up1"><enum>(I)</enum><text>reverse a determination of a medicare
administrative contractor under subparagraph (D) that is adverse to the
non-governmental party requesting it;</text>
</subclause><subclause id="H87EF9662F3C7409599227DA501ED9362" indent="up1"><enum>(II)</enum><text>correct an erroneous decision in the
determination of a limitation amount under paragraph (4)(B); or</text>
</subclause><subclause id="H3616EBD08F61428C9521B67C1EA64286" indent="up1"><enum>(III)</enum><text display-inline="yes-display-inline">reverse a determination referred to in
subclause (I) and correct an erroneous decision referred to in subclause
(II).</text>
</subclause></clause><clause id="HBE229F7F9A7C47CFA1AAB657C062A406" indent="up1"><enum>(ii)</enum><text>Any request under this subparagraph
shall include a statement of the basis for the non-governmental party’s belief
that an erroneous decision was made in determining such amount, together with
supporting evidence and a description of any additional data (other than data
already in the possession of the Secretary or the appropriate medicare
administrative contractor reviewing the request under subparagraph (D))
that–</text>
<subclause id="HDD9D60F606754BD2A0DA057547001B04"><enum>(I)</enum><text>are or may be in the possession of the
Secretary or an another medicare administrative contractor; and</text>
</subclause><subclause id="H69A6BA175DDC49768101816838E474BF"><enum>(II)</enum><text display-inline="yes-display-inline">are necessary to demonstrate that such an
erroneous decision exists.</text>
</subclause></clause><clause id="H91BCCED4F3994459A6650356796DF84" indent="up1"><enum>(iii)</enum><text display-inline="yes-display-inline">If the Secretary or another medicare
administrative contractor is identified as possessing or potentially possessing
additional data identified by a non-governmental 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 appropriate
safeguards to protect confidential and proprietary information.</text>
</clause><clause id="HE446AF4C7C2644BDA6670082BE01ADC9" indent="up1"><enum>(iv)</enum><text>If additional data are made
available to a non-governmental party under clause (iii), such party may amend
its request under this subparagraph to incorporate such data within 30 days
after the date such data are made available to such party.</text>
</clause><clause id="H0A029E21ADB449A2B9E6FA2F9EDCB0AE" indent="up1"><enum>(v)</enum><text>The Secretary shall make a
determination of whether to correct the erroneous decision that is the subject
of a request submitted under this subparagraph not later than 60 days after the
date of the submission of such request, or if later, the submission of an
amended request under clause (iv). The Secretary shall determine that the
non-governmental party submitting the request—</text>
<subclause id="HE05BD4D670B0459C95FF58A6A9714DC6"><enum>(I)</enum><text display-inline="yes-display-inline">has demonstrated that an erroneous decision
clearly was made, correct such erroneous decision, 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</text>
</subclause><subclause id="H34ADEBD7C77C43379232A0CD00F4CF9F"><enum>(II)</enum><text>has failed to demonstrate that an
erroneous decision clearly was made and decline to change the fee schedule
amount or national limitation amount, as the case may be,</text>
</subclause><continuation-text continuation-text-level="clause">and shall
provide to the non-governmental party with a written explanation of the basis
for such determination.</continuation-text></clause><clause id="H393C242B7E9A451BA78D2C6ED6E2F1F0" indent="up1"><enum>(vi)</enum><text>The Secretary may not reduce a fee
schedule amount pursuant to a request under this subparagraph and may reduce
such an amount only pursuant to section 1842(b)(8).</text>
</clause></subparagraph><subparagraph id="H9B91F868027544A9818316C11901BFC9" indent="up1"><enum>(F)</enum><clause commented="no" display-inline="yes-display-inline" id="H1D90D1A90EFB49CDA8004F1491C4656F"><enum>(i)</enum><text>There shall be no
administrative or judicial review under section 1869, 1878, or otherwise of any
determination made under subparagraph (D) or (E).</text>
</clause><clause id="HAD21F604A5CC4B6698356B3449277157" indent="up1"><enum>(ii)</enum><text>Nothing in this paragraph shall be
construed as precluding administrative or judicial review of determinations of
the amount of benefits that are available to a Medicare beneficiary in a
particular
case.</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H9A9599BAFC6A49C8A8AFD21EE9B9953"><enum>(b)</enum><header>Effective
date</header><text display-inline="yes-display-inline">The amendment made by
subsection (a) shall take effect on the date of the enactment of this Act and
shall apply to requests for corrections submitted on or after such date,
without regard to whether final regulations to carry out such amendment have
been issued.</text>
</subsection></section><section id="HC817BCF23C9248C28DF1E0E11B02B0C9"><enum>102.</enum><header>Issuance of
regulations on gap-filling for medicare fee schedule for clinical diagnostic
laboratory tests</header><text display-inline="no-display-inline">Not later
than one year after the date of the enactment of this Act, the Secretary of
Health and Human Services shall issue final regulations specifying how an
appropriate medicare administrative contractor (as defined in section
1874A(a)(3)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395kk-1">42 U.S.C. 1395kk–1(a)(3)(B)</external-xref>) shall
apply a gap-filling methodology in determining fee schedule amounts established
under section 1833(h)(2)(A)(i) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(h)(2)(A)(i)</external-xref>). Such
regulations shall specify—</text>
<paragraph id="HC7E795BA9E354E36839E45DF3F36F1A9"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph id="H40DFF967B4A44364A35EDE9EF5ED82D"><enum>(2)</enum><text>the principles to
be employed to ensure that such data are statistically significant and
alternatives to follow if statistically significant data are
unavailable;</text>
</paragraph><paragraph id="H87C235291D8842FBB5CD00084BA6F83"><enum>(3)</enum><text>the principles to
be followed in using data to calculate fee schedule amounts, including
principles for excluding data that do not meet the requirements of paragraph
(1) and (2);</text>
</paragraph><paragraph id="H4ACDC2BED52543EFBCF23FEF70CDC9F3"><enum>(4)</enum><text>the methods the
Secretary will use to oversee the application of a gap filling methodology by
such contractors and the remedies that will be available in cases in which such
a contractor fails to comply with regulatory requirements; and</text>
</paragraph><paragraph id="HF422F086D08D4C438310C492E416314"><enum>(5)</enum><text>a
process that provides opportunities for the public to participate in the
development of fee schedule 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.</text>
</paragraph></section><section id="HBBE5E54E663C4CBA86B7FE006E973D53"><enum>103.</enum><header>Increased
transparency of process for determining fee schedule amounts for new
tests</header><text display-inline="no-display-inline">Section 1833(h)(8) of
the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(h)(8)</external-xref> is amended—</text>
<paragraph id="HFFAD710F899F4B17A8B0BE740035F8E4"><enum>(1)</enum><text>in subparagraph
(B)(iii), by inserting “to be conducted in an inter-active format,” after
“meeting,”;</text>
</paragraph><paragraph id="H8E02E2921D71424A81E8EF4E8E858CB"><enum>(2)</enum><text>in
subparagraph (B)(iv)—</text>
<subparagraph id="HF9BFEECB3E0846878881F3FE50E497FD"><enum>(A)</enum><text display-inline="yes-display-inline">by inserting “(I)” after “meeting,”;</text>
</subparagraph><subparagraph id="H625DEDADE896468282DF931D88E266B"><enum>(B)</enum><text>by striking
“determination,” and inserting “determination and”; and</text>
</subparagraph><subparagraph id="H8AF5DE5B9E1D4F1990E99464780168E6"><enum>(C)</enum><text>by striking “a
request for” and inserting “(II) publishes in the Federal Register a notice of
a period of not less than 60 days during which the Secretary will receive”;
and</text>
</subparagraph></paragraph><paragraph id="H1028F0CED6D649279DEDB6424C69B1D7"><enum>(3)</enum><text>in subparagraph
(C), by striking “Under the procedures” and inserting “In the
regulations”.</text>
</paragraph></section><section id="H644279FCBA5F4C3C9DAE09C6D39FDA52"><enum>104.</enum><header>Advance notice
of clinical diagnostic laboratory test amounts being considered for adjustment
under inherent reasonableness authority</header>
<subsection id="H53BF91C26B644460A31DA3CEDC899568"><enum>(a)</enum><header>Limit on
inherent reasonableness authority</header><text display-inline="yes-display-inline">Section 1842(b)(9)(A) of the Social
Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395u">42 U.S.C. 1395u(b)(9)(A)</external-xref>) is amended by adding at the end the
following: “Before publishing a proposed notice 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 comments on the appropriateness of such an
adjustment for such test.”.</text>
</subsection><subsection id="H0D64C26124674D9CA13CB65EBF4596D7"><enum>(b)</enum><header>Conforming
change</header><text display-inline="yes-display-inline">Section 1833(h)(8)(B)
of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(h)(8)(B)</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H5D0EFF24B8474F7C9D2DA81E43DE5889" style="OLC">
<quoted-block-continuation-text quoted-block-continuation-text-level="section">At the
meeting required by clause (iii), the Secretary shall provide advance notice of
inherent reasonableness adjustments under section 1842(b)(8) that are being
considered for clinical diagnostic laboratory tests, and afford an opportunity
for non-governmental parties (as defined 1833(h)(9)(A)(iv)) at the meeting to
comment orally on the appropriateness of such an
adjustment.</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H10E5F07114AB47B09463A6ACB9C18F05"><enum>(c)</enum><header>Effective
date</header><text>The amendments made by this section shall become effective
on January 1, 2007, and shall apply to inherent reasonableness adjustments that
have not been proposed as of such date.</text>
</subsection></section><enum>II</enum><header>Future
Reform</header>
<section id="H69987E8536AC40B6ACF2EC9958896E25"><enum>201.</enum><header>Establishment
of medicare demonstration project to evaluate new approaches to coding and
payment for certain molecular diagnostic tests</header>
<subsection id="HECA8DACD86844EC7BF1DF18435CB5F4F"><enum>(a)</enum><header>Establishment of
demonstration</header>
<paragraph id="H0A26971C8A314C9FB51B7161D6D0C4CF"><enum>(1)</enum><header>Demonstration of
new approaches to coding and payment</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
(in this section referred to as the <quote>Secretary</quote>) shall establish a
demonstration project under this section (in this section referred to as the
“demonstration”) to evaluate new approaches to coding and payment under the
medicare program for clinical diagnostic laboratory tests included in the
demonstration (in this section referred to as “included tests”).</text>
</paragraph><paragraph id="H1A81A9797F354D269DDFB11F18864168"><enum>(2)</enum><header>Duration</header><text>The
demonstration and any payment amounts assigned under the demonstration shall
apply solely to claims submitted for included tests during the
12-calendar-quarter period that begins with the first day of the first calendar
quarter to begin at least 250 days after the date of the enactment of this
Act.</text>
</paragraph><paragraph id="H500E577B21BC4F5D9C25C3C6E4B012E1"><enum>(3)</enum><header>Scope</header><text>The
demonstration shall apply on a national basis to included tests in all settings
for which payment for such tests would (but for the demonstration) be made
under the fee schedules and limitation amounts established under section
1833(h) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(h)</external-xref>).</text>
</paragraph><paragraph id="HB7F6F1AA7CAF44B5AAE56378955F434B"><enum>(4)</enum><header> Issuance of
temporary hcpcs codes; continued application of such codes</header><text>The
Secretary shall issue a temporary code or codes under the Health Care Procedure
Coding System (HCPCS) when needed for an included test, and such code or
codes—</text>
<subparagraph id="HA45B7D81A7C44481ABC5E8F2441FEC9D"><enum>(A)</enum><text display-inline="yes-display-inline">shall continue to apply to the test until a
permanent code or codes is assigned; and</text>
</subparagraph><subparagraph id="H308D1D3330D54E64B5AD2894EF68AB02"><enum>(B)</enum><text>shall not cease
to apply solely because the demonstration ends.</text>
</subparagraph></paragraph></subsection><subsection id="H42CC721D35BF4C42B594FFF9E760012"><enum>(b)</enum><header>Included
tests</header>
<paragraph id="H53F20633D34F410ABDFF2CA3A189F44"><enum>(1)</enum><header>Eligible
tests</header><text display-inline="yes-display-inline">A clinical diagnostic
laboratory test is eligible to be an included test under the demonstration
if—</text>
<subparagraph id="HEE66DBE9C4CD4131AF2403F6787B91C"><enum>(A)</enum><text>the test is a new
or existing molecular diagnostic test that (but for its inclusion in the
demonstration) could be paid under the fee schedules and national limitation
amount established under section 1833(h) of the Social Security Act (42 U.S.C.
1395l(h)) for the test; and</text>
</subparagraph><subparagraph id="HC5CB818789AE41DE840208A4B98DB868"><enum>(B)</enum><text>there is the
prospect—</text>
<clause id="H9BF36FD6B27349D883002D1C77E4DFE2"><enum>(i)</enum><text display-inline="yes-display-inline">for wide usage of the test in multiple
geographic areas; and</text>
</clause><clause id="HF6E03B40E3A54AB59014B9A7C4A4A4AB"><enum>(ii)</enum><text>that development
of a new code, or payment, or both, for the test under the demonstration will
result in reduced administrative complexity and improved efficiency.</text>
</clause></subparagraph></paragraph><paragraph id="HE2C4F40686BB423F858FF39F00AB02C9"><enum>(2)</enum><header>Included
tests</header><text display-inline="yes-display-inline">A clinical diagnostic
laboratory test shall be treated as an included test if—</text>
<subparagraph id="HC9DFFE8B163B44F4AF003BC25E28C5C9"><enum>(A)</enum><text>an interested
party submits a request to the standing panel established under subsection (c)
that the test be included in the demonstration; and</text>
</subparagraph><subparagraph id="HFCEDFF566FE84FEBB3D725F100F65557"><enum>(B)</enum><text>the standing panel
determines that the test is an eligible test under paragraph (1); or</text>
</subparagraph></paragraph><paragraph id="H0ED50F47AD8540D2BCBD6C04B66415E3"><enum>(3)</enum><header>Definitions</header><text>For
purposes of this section—</text>
<subparagraph id="HBC9DE47BC35E4D57B992003D8F7744F1"><enum>(A)</enum><text display-inline="yes-display-inline">the term “molecular diagnostic test” means
a clinical diagnostic laboratory test performed on deoxyribonucleic (DNA),
ribonucleic acid (RNA), or protein that is drawn from a human being or from a
disease-causing organism; and</text>
</subparagraph><subparagraph id="H2E920545BA4343CC8DE9E6D1517C700"><enum>(B)</enum><text>the term
“interested party” means, with respect to a request for inclusion of molecular
diagnostic test in the demonstration, an individual entitled to benefits under
title XVIII of the Social Security Act, a manufacturer of the test, a clinical
laboratory offering the test, a professional society, the Centers for Medicare
& Medicaid Services, a private payer for such test, and a physician or
other health care practitioner.</text>
</subparagraph></paragraph></subsection><subsection id="H6373C1C2BF884846814508B97836F65"><enum>(c)</enum><header>Standing
panel</header>
<paragraph id="HD2E06AEDB85744CC8CA4169F2B00D067"><enum>(1)</enum><header>Appointment</header><text>Not
later than 60 days after the date of the enactment of this section, the
Secretary shall appoint a standing panel (in this section referred to as the
<quote>standing panel</quote> or <quote>panel</quote>) to determine whether a
test is an included test and make recommendations to the Secretary on the
appropriate coding of, and payment for, designated clinical diagnostic
laboratory tests under the demonstration.</text>
</paragraph><paragraph id="H4043EBB3D815459EAD2724EB7E00E6EA"><enum>(2)</enum><header>Composition of
panel</header>
<subparagraph id="H3F0CD18163F54A2FABD3DBBD13033DB"><enum>(A)</enum><header>In
general</header><text>The standing panel shall be comprised of 12 members. Two
of such members shall be non-voting representatives of the Administrator of the
Centers for Medicare & Medicaid Services. The Secretary shall appoint the
other 10 members from—</text>
<clause id="H3D93B85AE8E54B57821686FA493248F6"><enum>(i)</enum><text display-inline="yes-display-inline">organizations representing large clinical
laboratories;</text>
</clause><clause id="HFFA9F672908544D4BC9E6C334091C0DA"><enum>(ii)</enum><text>organizations
representing small clinical laboratories;</text>
</clause><clause id="H182C48A365F74FF7B7E51D2C5200B600"><enum>(iii)</enum><text>organizations
representing physicians with expertise in clinical diagnostic laboratory
tests;</text>
</clause><clause id="H96D01BCAFA634E96A2169BCD0902A2E6"><enum>(iv)</enum><text>organizations
representing other health professionals with expertise in such tests;</text>
</clause><clause id="H239F5C56FC8744E18921BFBB61B6DB31"><enum>(v)</enum><text>organizations
representing manufacturers of such tests;</text>
</clause><clause id="HE945A39970AE457691A62FFD74ADA55F"><enum>(vi)</enum><text>organizations
representing individuals entitled to benefits under title XVIII of the Social
Security Act;</text>
</clause><clause id="HB321AC25629543F593C84C89BDE7D52C"><enum>(vii)</enum><text>organizations
representing private payers for such tests (but not more than one member may be
appointed to represent such organizations);</text>
</clause><clause id="HD6D17C030A504CA3B098F64584DF68EC"><enum>(viii)</enum><text>individuals
with expertise in clinical laboratory cost accounting (both macro and micro);
and</text>
</clause><clause id="H659B8EF04D004D7FBB0004D2C1470D8"><enum>(ix)</enum><text>individuals with
other relevant expertise.</text>
</clause></subparagraph><subparagraph id="HA69C7029263F4B9DB199F4FE4C00D5ED"><enum>(B)</enum><header>Terms of
office</header><text display-inline="yes-display-inline">Each member of the
panel shall be appointed for the life of the panel, except that any individual
appointed to fill a vacancy shall be appointed for the remainder of the term of
the individual who is being replaced. Any vacancy shall be filled in the same
manner, and with a representative of the same category under subparagraph (A),
as the individual being replaced.</text>
</subparagraph></paragraph><paragraph id="H68700A671EE345FA9C11DEC5C52CAEEC"><enum>(3)</enum><header>Rules governing
panel</header>
<subparagraph id="H3E804F0291D2434AB665253947B41DBD"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">The panel shall elect
its chair. A quorum shall be required to conduct the business of the panel, and
eight members of the panel shall constitute a quorum.</text>
</subparagraph><subparagraph id="H10931132B19F4C7095428382ED6500F"><enum>(B)</enum><header>Compensation</header><text>While
serving on the business of the panel (including travel time), a member of the
panel shall be entitled to compensation at the per diem equivalent rate
provided for level IV of the Executive Schedule under <external-xref legal-doc="usc" parsable-cite="usc/5/5315">section 5315</external-xref> of title 5,
United States Code, and while so serving away from home and the member’s
regular place of business, a member may be allowed travel expenses as
authorized by the chair of the panel.</text>
</subparagraph><subparagraph id="H0299E3A197E9489EA84778A841A6AB03"><enum>(C)</enum><header>Staffing</header>
<clause id="H8A30C387584B4D29AA3434C51C563E27"><enum>(i)</enum><header>Detailing</header><text display-inline="yes-display-inline">The panel may seek such assistance and
support of its duties from appropriate Federal Departments and agencies.</text>
</clause><clause id="HDBFEBD52B1E24CE4985502D615EDA8E2"><enum>(ii)</enum><header>Outside
experts</header><text>The panel may retain the services of such outside experts
as are necessary for the evaluation of a request under this section, and such
experts shall not be voting members of the panel.</text>
</clause></subparagraph><subparagraph id="H9A1F5974EC3942BAB4512220ACEF73C"><enum>(D)</enum><header>Meetings</header><text>The
panel shall meet at the call of the chair and at such intervals (which shall
not be less than quarterly) as may be necessary for the conduct of its
business. The agenda of each meeting and a notice of its date shall be
published at least 30 days before the date the meeting occurs, and, except as
provided in subparagraph (E), meetings of the panel shall be open to the
public.</text>
</subparagraph><subparagraph id="H06F6997B2DB34DABAFF12CD9CC1BF696"><enum>(E)</enum><header>Faca</header><text>The
Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the panel,
but the panel may close any portion of a meeting that could be closed if such
Act applied.</text>
</subparagraph><subparagraph id="H5A61D3F3885D4054AE293556974205ED"><enum>(F)</enum><header>Termination of
panel</header><text display-inline="yes-display-inline">The panel shall
terminate not more than 180 days after the close of the demonstration.</text>
</subparagraph></paragraph></subsection><subsection id="H38EDC7F19296442097FE2DF8A7F3462"><enum>(d)</enum><header>Form and content
of requests for inclusion in the demonstration</header><text>A request for
inclusion of a clinical diagnostic laboratory test in the demonstration shall
be submitted in such form, and shall contain such information as the standing
panel may require, including at least—</text>
<paragraph id="H168B7C3364F94B3EB3F5B3FBC19BBABC"><enum>(1)</enum><text display-inline="yes-display-inline">any coding and payment determinations
requested with respect to the test; and</text>
</paragraph><paragraph id="H5849B22232BB439CBE98CF68FEFEB93D"><enum>(2)</enum><text>any documentation
in support of—</text>
<subparagraph id="HA7B750F88A034613AA819CC740F029D2"><enum>(A)</enum><text>the eligibility of
the test for inclusion in the demonstration; and</text>
</subparagraph><subparagraph id="H1F746631A3ED4877A2007E7938000593"><enum>(B)</enum><text>any coding and
payment determinations requested with respect to the test, including data on
the typical direct and indirect laboratory costs (including test acquisition
costs) of the test.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">The
Secretary shall cause to have published in the Federal Register and on an
appropriate internet site public notice of each such request. Such information
shall be supplied to the Secretary by the standing panel.</continuation-text></paragraph></subsection><subsection id="HCBF1F8A4DEBA4E6E96B96D260074198C"><enum>(e)</enum><header>Criteria for
evaluating requests for determinations in coding and payment</header>
<paragraph id="H15D591058F974F46A6A2FA2082817CC"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">In determining
whether a requested payment determination should be granted, and what the new
payment amount for a test should be, the standing panel (in making its
recommendations to the Secretary) and the Secretary (in determining whether to
grant such a determination) shall take into account typical direct and indirect
laboratory costs (including test acquisition costs), the expected impact of the
test on patient care management, and such other factors as the standing panel
and the Secretary, respectively, determine to be relevant to the
determination.</text>
</paragraph><paragraph id="H21FCD507EDED43CFA38D20E298B84D2E"><enum>(2)</enum><header>Standing
panel</header><text>Not later than 180 days after the appointment of all of the
members of the panel, the panel shall, after consultation with the Secretary,
establish and make available to the public—</text>
<subparagraph id="H984364A17F4B43B5B2B9662647A3BE26"><enum>(A)</enum><text display-inline="yes-display-inline">standards and parameters for determining
whether to recommend to the Secretary a coding or payment determination
specified in a request for inclusion of a test in the demonstration, which
shall include a listing of data elements necessary to support a request and a
standardized procedure for collecting and submitting data on typical costs to
the panel;</text>
</subparagraph><subparagraph id="H73CE1B0984CD4C89B31C0050AB690762"><enum>(B)</enum><text>policies and
procedures for protecting the confidentiality of financial and other
proprietary data submitted to the panel in support of a request; and</text>
</subparagraph><subparagraph id="HC732E05EE29F4280BE699268E2CD182D"><enum>(C)</enum><text>cost intervals or
cost bands (as described in subsection (g)(1)) that the panel recommends that
the Secretary should use for the assignment of included tests under the
demonstration.</text>
</subparagraph></paragraph><paragraph id="HD0E8B065F2B74F639B86DCC15CCD97F6"><enum>(3)</enum><header>Secretarial
determinations</header><text display-inline="yes-display-inline">The Secretary
shall develop and make available to public on an internet site guidance
documents on the standards and parameters that will be applied in making
Secretarial determinations and on the cost intervals or cost bands to be used
under the demonstration and on whether to grant a request for a payment or
coding determination. Such guidance documents shall be developed, which shall
be made available to the public at least 10 days before the beginning of the
demonstration, in a manner similar to the manner in which guidance documents
are developed under section 701(h) of the Federal Food, Drug, and Cosmetic Act
(<external-xref legal-doc="usc" parsable-cite="usc/21/371">21 U.S.C. 371(h)</external-xref>).</text>
</paragraph><paragraph id="H0063496CCB3C471E9DD5474786B73DB1"><enum>(4)</enum><header>Authority to
recommend revisions to, and to revise, cost intervals or cost
bands</header><text display-inline="yes-display-inline">Nothing in this section
shall be construed as limiting the authority of the standing panel to
recommend, or the Secretary to adopt, new cost intervals or cost bands to
accommodate changes in technology.</text>
</paragraph></subsection><subsection id="H3F8BB52E2EFE4B889B2487E199EE8EA9"><enum>(f)</enum><header>Review
process</header>
<paragraph id="H731BB5B338EF438F8E87004F8C05402B"><enum>(1)</enum><header>Requests for
inclusion in demonstration</header><text>An interested party may submit a
request for inclusion of a test in the demonstration to the standing panel at
any time during a calendar year for which the demonstration is in effect,
except that the standing panel may decline to review and make recommendations
or determinations with respect to any request that would result in a requested
coding or payment determination being effective for a period of less than 4
calendar quarters.</text>
</paragraph><paragraph id="H08CB2E53227B41C58FD2AB94B13F99F4"><enum>(2)</enum><header>Recommendations
of standing panel</header><text display-inline="yes-display-inline">The
standing panel shall review each request for a coding or payment determination
that is made with respect to an included test. Applying the standards and
parameters developed under subsection (e)(2)(A), the panel shall make a
recommendation to the Secretary with respect to each requested
determination.</text>
</paragraph><paragraph id="HD44BDAEF7702402985CEC5076532E094"><enum>(3)</enum><header>Secretarial
determinations</header>
<subparagraph id="H56FDC9422A784510A34B005097A5004D"><enum>(A)</enum><header>Quarterly
determinations</header><text>The Secretary shall make determinations on whether
to grant requested coding and payment determinations on a quarterly basis, but
is not required to make such a determination for every request made (or with
respect to which a recommendation is received from the standing panel) during a
particular quarter.</text>
</subparagraph><subparagraph id="HE8EB7B04843F4B39895F7F5E00F1E100"><enum>(B)</enum><header>Time frames for
determinations</header><text>Determinations of the Secretary shall be made in a
timely manner in accordance with time frames developed by the standing panel
taking into account factors such as when a request (and a recommendation with
respect to the request) is made during a quarter, the particular type of test
involved, and the staffing and resources that may be required to review the
request.</text>
</subparagraph></paragraph></subsection><subsection id="H27EA4AC5F9D9467E99FCEA78A16435D1"><enum>(g)</enum><header> Payment
methodology</header>
<paragraph id="HB6950A2A05FA4DD2B1FD7F907E210061"><enum>(1)</enum><header> In
general</header><text>Included tests shall be paid in accordance with a
methodology, developed by the standing panel, that establishes cost intervals
or cost bands in a manner similar to those that are used as new technology
ambulatory payment classification groups for hospital outpatient services under
section 1833(t) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(t)</external-xref>), with a test
being assigned to the cost interval or cost band that most closely approximates
the typical direct and indirect costs (including test acquisition costs) of the
test for a laboratory. Tests that are included tests for purposes of this
section shall be excluded from any demonstration project under section 1847(e)
of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-3">42 U.S.C. 1395w–3(e)</external-xref>).</text>
</paragraph><paragraph id="HFC75A371DFCB46BAAE2DE8B404C5984E"><enum>(2)</enum><header>Panel
recommendations; secretarial determinations</header>
<subparagraph id="HCBB512B2244841E2B92087AD1CFFC75"><enum>(A)</enum><header>Recommendations;
secretarial determinations</header><text>The standing panel shall recommend to
the Secretary a cost interval or cost band to which an included test should be
assigned, and the Secretary may assign such test to such band or interval or to
another band or interval the Secretary determines to more closely approximate
the typical direct and indirect costs (including test acquisition costs) of the
test.</text>
</subparagraph><subparagraph id="H8CD4F3899E584B7F8E4648525F17B833"><enum>(B)</enum><header>Explanation of
determination that differs from recommendation</header><text display-inline="yes-display-inline">If the Secretary assigns a test to a cost
interval or band other than that recommended by the standing panel, the
Secretary shall provide a detailed written explanation of the reasons for
determining that such other interval or band is more appropriate.</text>
</subparagraph></paragraph><paragraph id="HE751F5D031924B4900E6A646F036A82B"><enum>(3)</enum><header>Effective date
of secretarial determination</header><text display-inline="yes-display-inline">A determination by the Secretary with
respect to a coding or payment determination for an included test shall become
effective as of the first day of the calendar quarter following the calendar
quarter in which the determination is made.</text>
</paragraph><paragraph id="H1F7D871BC0E140E3004D38B5967E00F9"><enum>(4)</enum><header>Periodic
look-backs of interval or band assignments</header><text>At the request of the
interested party that submitted the initial request for a test to be included
in the demonstration or of a member of the standing panel, the standing panel
may review the appropriateness of the payment interval or band to which the
test is assigned and make a recommendation to the Secretary that the assignment
be changed. The Secretary may accept or reject such recommendation, and if the
recommendation is rejected, the Secretary shall provide a detailed explanation
of the reasons for such rejection.</text>
</paragraph><paragraph id="H59AEDC45A4E14D56BD3391CD746B003E"><enum>(5)</enum><header>Publication of
determinations</header><text>The Secretary shall publish determinations under
this subsection in a timely manner on an appropriate internet site.</text>
</paragraph></subsection><subsection id="H9BE89A55A2D04DBA98F78FF2C937BFA2"><enum>(h)</enum><header>Reports to
congress</header>
<paragraph id="H5BF014158D7B41B9B29EA1F635DE7EE2"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall
submit interim and final reports on the demonstration to the Committees on Ways
and Means and Energy and Commerce of the House of Representatives and the
Committee on Finance of the Senate. The interim report shall be submitted not
later than the close of the second year of the demonstration, and the final
report shall be submitted not later than 180 days after the close of the
demonstration.</text>
</paragraph><paragraph id="HFF24404808924538840099B3757D2BDA"><enum>(2)</enum><header>Content of
reports</header><text>The reports submitted under paragraph (1) shall include
interim and final—</text>
<subparagraph id="HAC1741940DEE4417849D61F2FE925F68"><enum>(A)</enum><text>determinations on
whether coding and payment assignments under the demonstration provide
for—</text>
<clause id="HA841CA697D864621910433DCF08321DF"><enum>(i)</enum><text>more
equitable and accurate payment for included tests; and</text>
</clause><clause id="HE81021627627454E8FB0AF01DD6C56F2"><enum>(ii)</enum><text>reduced
administrative complexity, improved efficiency, and improved access to care;
and</text>
</clause></subparagraph><subparagraph id="H01B21A34E535475FA261889B0345E7A2"><enum>(B)</enum><text display-inline="yes-display-inline">recommendations on—</text>
<clause id="H2BC62406C66F4A568E3122ABFC77614C"><enum>(i)</enum><text>whether the
alternative mechanism for determining payment and coding for included tests
should be continued for such tests beyond the 12-calendar-quarter period the
demonstration is in effect; and</text>
</clause><clause id="HF246D35404F245668FEE5FB9B176D796"><enum>(ii)</enum><text>whether the
application of such mechanism should be expanded to include other new clinical
diagnostic laboratory tests for which payment would otherwise be made under the
fee schedules and limits established under section 1833(h) of the Social
Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(h)</external-xref>).</text>
</clause></subparagraph></paragraph><paragraph id="HF0B47B03FB5C4F79A927C8429C677FB8"><enum>(3)</enum><header>Comments by
standing panel</header><text>The standing panel shall submit comments to the
committees referred to in paragraph (1) on the interim and final reports of the
Secretary.</text>
</paragraph></subsection><subsection id="H79AECD9638354D919B318289DE0066AF"><enum>(i)</enum><header>Authorization of
appropriations</header><text display-inline="yes-display-inline">There are
authorized to be appropriated for each of fiscal years 2007 through 2012, such
sums as may be necessary to carry out this section.</text>
</subsection></section>