Medicare Clinical Laboratory Fee Schedule Improvement Act of 2006 - Amends title XVIII (Medicare) of the Social Security Act with respect to: (1) correction of erroneous determinations and other changes in fee schedule and national limitation amounts for clinical diagnostic laboratory tests; (2) issuance of regulations on gap-filling methodology in determining the Medicare fee schedule for such tests; (3) increased transparency of process for determining fee schedule amounts for new tests; and (4) mandatory advance notice of clinical diagnostic laboratory test amounts being considered for adjustment under inherent reasonableness authority.
Directs the Secretary to: (1) establish a demonstration project to evaluate new approaches to coding and payment under the Medicare program for clinical diagnostic laboratory tests; and (2) appoint a standing panel to determine tests to be included in the project and make recommendations derived from project results to the Secretary of Health and Human Services.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5369 Introduced in House (IH)]
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
referred to the Committee on Energy and Commerce, and in addition to
the Committee on Ways and Means, for a period to be subsequently
determined 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 Representatives 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:
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.
TITLE I--NEAR-TERM CHANGES
SEC. 101. FEE SCHEDULE AND NATIONAL LIMITATION AMOUNTS FOR CLINICAL
DIAGNOSTIC LABORATORY TESTS.
(a) In General.--Section 1833(h) of the Social Security 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 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.
``(ii) The terms `appropriate medicare administrative
contractor' and `medicare administrative contractor' 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 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.
``(iv) The term `non-governmental party' includes--
``(I) 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;
``(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 performing such test.
``(B) An amount determined under this subsection may be changed
solely on the basis of--
``(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 regulatory guidance implementing such
provisions; or
``(ii) 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).
``(C) Any erroneous decision in determining an amount under this
subsection may be corrected only if--
``(i) a non-governmental party submits a request under
subparagraph (D) or (E) for correction of the erroneous
decision; and
``(ii) 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.
``(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.
``(ii) 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--
``(I) is or may be in the possession of the Secretary or
another medicare administrative contractor; and
``(II) is necessary to demonstrate that such an erroneous
decision exists.
``(iii) 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.
``(iv) 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.
``(v) 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--
``(I) 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
``(II) has failed to demonstrate that an erroneous 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 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).
``(E)(i) Any non-governmental party may request (in such form and
manner as the Secretary may require) that the Secretary--
``(I) reverse a determination of a medicare administrative
contractor under subparagraph (D) that is adverse to the non-
governmental party requesting it;
``(II) correct an erroneous decision in the determination
of a limitation amount under paragraph (4)(B); or
``(III) reverse a determination referred to in subclause
(I) and correct an erroneous decision referred to in subclause
(II).
``(ii) 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-
``(I) are or may be in the possession of the Secretary or
an another medicare administrative contractor; and
``(II) are necessary to demonstrate that such an erroneous
decision exists.
``(iii) 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.
``(iv) 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.
``(v) 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--
``(I) 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
``(II) 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,
and shall provide to the non-governmental party with a written
explanation of the basis for such determination.
``(vi) 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).
``(F)(i) There shall be no administrative or judicial review under
section 1869, 1878, or otherwise of any determination made under
subparagraph (D) or (E).
``(ii) 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.''.
(b) Effective Date.--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.
SEC. 102. ISSUANCE OF REGULATIONS ON GAP-FILLING FOR MEDICARE FEE
SCHEDULE FOR CLINICAL DIAGNOSTIC LABORATORY TESTS.
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 (42 U.S.C. 1395kk-1(a)(3)(B)) shall apply a gap-filling methodology
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 alternatives to follow if
statistically significant data are unavailable;
(3) 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);
(4) 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
(5) 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.
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 ``meeting,'';
(2) in subparagraph (B)(iv)--
(A) by inserting ``(I)'' after ``meeting,'';
(B) by striking ``determination,'' and inserting
``determination and''; and
(C) 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
(3) in subparagraph (C), by striking ``Under the
procedures'' and inserting ``In the regulations''.
SEC. 104. ADVANCE NOTICE OF CLINICAL DIAGNOSTIC LABORATORY TEST AMOUNTS
BEING CONSIDERED FOR ADJUSTMENT UNDER INHERENT
REASONABLENESS AUTHORITY.
(a) Limit on Inherent Reasonableness Authority.--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 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.''.
(b) Conforming Change.--Section 1833(h)(8)(B) of such Act (42
U.S.C. 1395l(h)(8)(B)) is amended by adding at the end the following:
``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.''.
(c) Effective Date.--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.
TITLE II--FUTURE REFORM
SEC. 201. ESTABLISHMENT OF MEDICARE DEMONSTRATION PROJECT TO EVALUATE
NEW APPROACHES TO CODING AND PAYMENT FOR CERTAIN
MOLECULAR DIAGNOSTIC TESTS.
(a) Establishment of Demonstration.--
(1) Demonstration of new approaches to coding and
payment.--The Secretary of Health and Human Services (in this
section referred to as the ``Secretary'') 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'').
(2) Duration.--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.
(3) Scope.--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 (42 U.S.C. 1395l(h)).
(4) Issuance of temporary hcpcs codes; continued
application of such codes.--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--
(A) shall continue to apply to the test until a
permanent code or codes is assigned; and
(B) shall not cease to apply solely because the
demonstration ends.
(b) Included Tests.--
(1) Eligible tests.--A clinical diagnostic laboratory test
is eligible to be an included test under the demonstration if--
(A) 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
(B) there is the prospect--
(i) for wide usage of the test in multiple
geographic areas; and
(ii) 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.
(2) Included tests.--A clinical diagnostic laboratory test
shall be treated as an included test if--
(A) an interested party submits a request to the
standing panel established under subsection (c) that
the test be included in the demonstration; and
(B) the standing panel determines that the test is
an eligible test under paragraph (1); or
(3) Definitions.--For purposes of this section--
(A) 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
(B) 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.
(c) Standing Panel.--
(1) Appointment.--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 ``standing
panel'' or ``panel'') 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.
(2) Composition of panel.--
(A) In general.--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--
(i) organizations representing large
clinical laboratories;
(ii) organizations representing small
clinical laboratories;
(iii) organizations representing physicians
with expertise in clinical diagnostic
laboratory tests;
(iv) organizations representing other
health professionals with expertise in such
tests;
(v) organizations representing
manufacturers of such tests;
(vi) organizations representing individuals
entitled to benefits under title XVIII of the
Social Security Act;
(vii) organizations representing private
payers for such tests (but not more than one
member may be appointed to represent such
organizations);
(viii) individuals with expertise in
clinical laboratory cost accounting (both macro
and micro); and
(ix) individuals with other relevant
expertise.
(B) Terms of office.--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.
(3) Rules governing panel.--
(A) In general.--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.
(B) Compensation.--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 section 5315 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.
(C) Staffing.--
(i) Detailing.--The panel may seek such
assistance and support of its duties from
appropriate Federal Departments and agencies.
(ii) Outside experts.--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.
(D) Meetings.--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.
(E) Faca.--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.
(F) Termination of panel.--The panel shall
terminate not more than 180 days after the close of the
demonstration.
(d) Form and Content of Requests for Inclusion in the
Demonstration.--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--
(1) any coding and payment determinations requested with
respect to the test; and
(2) any documentation in support of--
(A) the eligibility of the test for inclusion in
the demonstration; and
(B) 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.
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.
(e) Criteria for Evaluating Requests for Determinations in Coding
and Payment.--
(1) In general.--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.
(2) Standing panel.--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--
(A) 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;
(B) policies and procedures for protecting the
confidentiality of financial and other proprietary data
submitted to the panel in support of a request; and
(C) 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.
(3) Secretarial determinations.--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 (21
U.S.C. 371(h)).
(4) Authority to recommend revisions to, and to revise,
cost intervals or cost bands.--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.
(f) Review Process.--
(1) Requests for inclusion in demonstration.--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.
(2) Recommendations of standing panel.--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.
(3) Secretarial determinations.--
(A) Quarterly determinations.--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.
(B) Time frames for determinations.--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.
(g) Payment Methodology.--
(1) In general.--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 (42 U.S.C.
1395l(t)), 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 (42 U.S.C. 1395w-3(e)).
(2) Panel recommendations; secretarial determinations.--
(A) Recommendations; secretarial determinations.--
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.
(B) Explanation of determination that differs from
recommendation.--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.
(3) Effective date of secretarial determination.--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.
(4) Periodic look-backs of interval or band assignments.--
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.
(5) Publication of determinations.--The Secretary shall
publish determinations under this subsection in a timely manner
on an appropriate internet site.
(h) Reports to Congress.--
(1) In general.--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.
(2) Content of reports.--The reports submitted under
paragraph (1) shall include interim and final--
(A) determinations on whether coding and payment
assignments under the demonstration provide for--
(i) more equitable and accurate payment for
included tests; and
(ii) reduced administrative complexity,
improved efficiency, and improved access to
care; and
(B) recommendations on--
(i) 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
(ii) 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 (42
U.S.C. 1395l(h)).
(3) Comments by standing panel.--The standing panel shall
submit comments to the committees referred to in paragraph (1)
on the interim and final reports of the Secretary.
(i) Authorization of Appropriations.--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.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
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