Prohibits the Secretary from assigning a code for a new clinical diagnostic laboratory test that differs from the code recommended by the American Medical Association Common Procedure Terminology Editorial Panel and results in lower payment than would be made if the Secretary accepted such recommendation solely on the basis that the test is a test that may be performed by a laboratory with a certificate of waiver under the Public Health Service Act.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1798 Introduced in House (IH)]
107th CONGRESS
1st Session
H. R. 1798
To amend title XVIII of the Social Security Act to establish procedures
for determining payment amounts for new clinical diagnostic laboratory
tests for which payment is made under the Medicare Program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 10, 2001
Ms. Dunn of Washington (for herself, Mr. Ehrlich, Mr. McDermott, and
Mr. Ramstad) 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 establish procedures
for determining payment amounts for new clinical diagnostic laboratory
tests for which payment is made under the Medicare Program.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medicare Patient Access to
Preventive and Diagnostic Tests Act''.
SEC. 2. CODING AND PAYMENT PROCEDURES FOR NEW CLINICAL DIAGNOSTIC
LABORATORY TESTS UNDER MEDICARE.
(a) Determining Payment Basis For New Lab Tests.--Section 1833(h)
of the Social Security Act (42 U.S.C. 1395l(h)) is amended by adding at
the end the following:
``(9)(A) The Secretary shall establish procedures for
determining the basis for, and amount of, payment under this
subsection for any clinical diagnostic laboratory test with
respect to which a new or substantially revised HCPCS code is
assigned on or after January 1, 2002 (hereinafter in this
paragraph and paragraph (10) referred to as `new tests'). Such
procedures shall provide that--
``(i) the payment amount for such a test will be
established only on--
``(I) the basis described in paragraph
(10)(A); or
``(II) the basis described in paragraph
(10)(B); and
``(ii) the Secretary will determine whether the
payment amount for such a test is established on the
basis described in paragraph (10)(A) or the basis
described in paragraph (10)(B) only after the process
described in subparagraph (B) has been completed with
respect to such test.
``(B) Determinations under subparagraph (A)(ii) shall be
made only after the Secretary--
``(i) makes available to the public (through an
Internet site and other appropriate mechanisms) a list
that includes any such test for which establishment of
a payment amount under paragraph (10) is being
considered for a year;
``(ii) on the same day such list is made available,
causes to have published in the Federal Register notice
of a meeting to receive comments and recommendations
from the public on the appropriate basis under
paragraph (10) for establishing payment amounts for the
tests on such list;
``(iii) not less than 30 days after publication of
such notice, convenes a meeting to receive such
comments and recommendations, with such meeting--
``(I) including representatives of all
entities within the Health Care Financing
Administration (hereinafter in this paragraph
referred to as `HCFA') that will be involved in
determining the basis on which payment amounts will be established for
such tests under paragraph (10) and implementing such determinations;
``(II) encouraging the participation of
interested parties, including beneficiaries,
device manufacturers, clinical laboratories,
laboratory professionals, pathologists, and
prescribing physicians, through outreach
activities; and
``(III) affording opportunities for
interactive dialogue between representatives of
HCFA and the public;
``(iv) makes minutes of such meeting available to
the public (through an Internet site and other
appropriate mechanisms) not later than 15 calendar days
after such meeting;
``(v) taking into account the comments and
recommendations received at such meeting, develops and
makes available to the public (through an Internet site
and other appropriate mechanisms) a list of proposed
determinations with respect to the appropriate basis
for establishing a payment amount under paragraph (10)
for each such code, together with an explanation of the
reasons for each such determination, and the data on
which the determination is based;
``(vi) on the same day such list is made available,
causes to have published in the Federal Register notice
of a public meeting to receive comments and
recommendations from the public on the proposed
determinations;
``(vii) not later than August 1 of each year, but
at least 30 days after publication of such notice,
convenes a meeting to receive such comments and
recommendations, with such meeting being conducted in
the same manner as the meeting under clause (iii);
``(viii) makes a transcript of such meeting
available to the public (through an Internet site and
other appropriate mechanisms) as soon as is practicable
after such meeting; and
``(ix) taking into account the comments and
recommendations received at such meeting, develops and
makes available to the public (through an Internet site
and other appropriate mechanisms) a list of final
determinations of whether the payment amount for such
tests will be determined on the basis described in
paragraph (10)(A) or the basis described in paragraph
(10)(B), together with the rationale for each such
determination, the data on which the determination is
based, and responses to comments and suggestions
received from the public.
``(C) Under the procedures established pursuant to
subparagraph (A), the Secretary shall--
``(i) identify the rules and assumptions to be
applied by the Secretary in considering and making
determinations of whether the payment amount for a new
test should be established on the basis described in
paragraph (10)(A) or the basis described in paragraph
(10)(B);
``(ii) make available to the public the data (other
than proprietary data) considered in making such
determinations; and
``(iii) provide for a mechanism under which--
``(I) an interested party may request an
administrative review of an adverse
determination;
``(II) upon the request of an interested
party, an administrative review is conducted
with respect to an adverse determination; and
``(III) such determination is revised, as
necessary, to reflect the results of such
review.
``(D) For purposes of this paragraph and paragraph
(10)--
``(i) the term `HCPCS' refers to the Health
Care Financing Administration Common Procedure
Coding System; and
``(ii) a code shall be considered to be
`substantially revised' if there is a
substantive change to the definition of the
test or procedure to which the code applies
(such as a new analyte or a new methodology for
measuring an existing analyte-specific test).
``(10)(A) Notwithstanding paragraphs (1), (2), and (4), if
a new test is clinically similar to a test for which a fee
schedule amount has been established under paragraph (5), the
Secretary shall pay the same fee schedule amount for the new
test. In determining whether tests are clinically similar for
purposes of this paragraph, the Secretary may not take into
account economic factors.
``(B)(i) Notwithstanding paragraphs (1), (2), (4), and (5),
if a new test is not clinically similar to a test for which a
fee schedule has been established under paragraph (5), payment
under this subsection for such test shall be made on the basis
of the lesser of--
``(I) the actual charge for the test; or
``(II) an amount equal to 60 percent (or in the
case of a test performed by a qualified hospital (as
defined in paragraph (1)(D)) for outpatients of such
hospital, 62 percent) of the prevailing charge level
determined pursuant to the third and fourth sentences
of section 1842(b)(3) for the test for a locality or
area for the year (determined without regard to the
year referred to in paragraph (2)(A)(i), or any
national limitation amount under paragraph (4)(B), and
adjusted annually by the percentage increase or
decrease under paragraph (2)(A)(i));
until the beginning of the third full calendar year that begins
on or after the date on which an HCPCS code is first assigned
with respect to such test, or, if later, the beginning of the
first calendar year that begins on or after the date on which
the Secretary determines that there are sufficient claims data
to establish a fee schedule amount pursuant to clause (ii).
``(ii) Notwithstanding paragraphs (2) and (4), and (5), the
fee schedule amount for a clinical diagnostic laboratory test
described in clause (i) that is performed--
``(I) during the first calendar year after clause
(i) ceases to apply to such test, shall be an amount
equal to the national limitation amount that the
Secretary determines (consistent with clause (iii))
would have applied to such test under paragraph
(4)(B)(viii) during the preceding calendar year,
adjusted by the percentage increase or decrease
determined under paragraph (2)(A)(i) for such first
calendar year; and
``(II) during a subsequent year, is the fee
schedule amount determined under this clause for the
preceding year, adjusted by the percentage increase or
decrease that applies under paragraph (5)(A) for such
year.
``(iii) For purposes of clause (ii)(I), the national
limitation amount for a test shall be set at 100 percent of the
median of the payment amounts determined under clause (ii)(I)
for all payment localities or areas for the last calendar year
for which payment for such test was determined under clause
(i).
``(iv) Nothing in clause (ii) shall be construed as
prohibiting the Secretary from applying (or authorizing the
application of) the comparability provisions of the first
sentence of such section 1842(b)(3) with respect to amounts
determined under such clause.''.
(b) Establishment of National Fee Schedule Amounts.--
(1) In general.--Section 1833(h) of the Social Security
Act, as amended by subsection (a), is further amended--
(A) in paragraph (2), by striking ``paragraph (4)''
and inserting in lieu thereof ``paragraphs (4), (5),
and (10)'';
(B) in paragraph (4)(B)(viii), by inserting ``and
before January 1, 2002,'' after ``December 31, 1997,'';
(C) by redesignating paragraphs (5), (6), and (7),
as paragraphs (6), (7), and (8), respectively; and
(D) by inserting after paragraph (4) the following:
``(5) Notwithstanding paragraphs (2) and (4), the Secretary
shall set the fee schedule amount for a test (other than a test
to which paragraph (10)(B)) applies) at--
``(A) for tests performed during 2002, an amount
equal to the national limitation amount for that test
for 2001, and adjusted by the percentage increase or
decrease determined under paragraph (2)(A)(i) for such
year; and
``(B) for tests performed during a year after 2002,
the amount determined under this subparagraph for the
preceding year, adjusted by the percentage increase or
decrease determined under paragraph (2)(A)(i) for such
year.''.
(2) Conforming changes.--Section 1833(a) of the Social
Security Act (42 U.S.C. 1395l(a)) is amended--
(A) in paragraph (1)(D)(i), by striking ``the
limitation amount for that test determined under
subsection (h)(4)(B),''; and
(B) in paragraph (2)(D)(i), by striking ``the
limitation amount for that test determined under
subsection (h)(4)(B),''.
(c) Mechanism for Review of Adequacy of Payment Amounts.--Section
1833(h) of the Social Security Act, as amended by subsections (a) and
(b), is further amended by adding at the end the following:
``(11) The Secretary shall establish a mechanism under
which--
``(A) an interested party may request a timely
review of the adequacy of the existing payment amount
under this subsection fee for a particular test; and
``(B) upon the receipt of such a request, a timely
review is carried out.''.
(d) Use of Inherent Reasonableness Authority.--Section 1842(b)(8)
of the Social Security Act (42 U.S.C. 1395u(b)(8)) is amended by adding
at the end the following:
``(E)(i) The Secretary may not delegate the
authority to make determinations with respect to
clinical diagnostic laboratory tests under this
paragraph to a regional office of the Health Care
Financing Administration or to an entity with a
contract under subsection (a).
``(ii) In making determinations with respect to
clinical diagnostic laboratory tests under this
paragraph, the Secretary--
``(I) shall base such determinations on
data from affected payment localities and all
sites of care; and
``(II) may not use a methodology that
assigns undue weight to the prevailing charge
levels for any one type of entity with a
contract under subsection (a).''.
(e) Prohibition.--The Secretary may not assign a code for a new
clinical diagnostic laboratory test that differs from the code
recommended by the American Medical Association Common Procedure
Terminology Editorial Panel and results in lower payment than would be
made if the Secretary accepted such recommendation solely on the basis
that the test is a test that may be performed by a laboratory with a
certificate of waiver under section 353(d)(2) of the Public Health
Service Act (42 U.S.C. 263a(d)(2)).
(f) Effective Dates.--
(1) Establishment of procedures.--The Secretary of Health
and Human Services shall establish the procedures required to
implement paragraphs (9), (10), and (11) of section 1833(h) of
the Social Security Act (42 U.S.C. 1395l(h)), as added by this
section, by not later than October 1, 2001.
(2) Inherent reasonableness; code assignment.--The
amendments made by subsections (d) and (e) shall apply to
determinations made on or after the date of the enactment of
this Act.
<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.
Referred to the Subcommittee on Health.
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