[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4449 Introduced in Senate (IS)]
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117th CONGRESS
2d Session
S. 4449
To amend title XVIII of the Social Security Act to improve the accuracy
of market-based Medicare payment for clinical diagnostic laboratory
services, to reduce administrative burdens in the collection of data,
and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 22, 2022
Mr. Burr (for himself and Mr. Brown) introduced the following bill;
which was read twice and referred to the Committee on Finance
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to improve the accuracy
of market-based Medicare payment for clinical diagnostic laboratory
services, to reduce administrative burdens in the collection of data,
and for other purposes.
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 ``Saving Access to Laboratory Services
Act''.
SEC. 2. MODIFICATION OF REQUIREMENTS FOR MEDICARE CLINICAL DIAGNOSTIC
LABORATORY TESTS.
(a) Use of Statistical Sampling for Widely Available Clinical
Diagnostic Laboratory Tests.--
(1) In general.--Section 1834A(a)(1) of the Social Security
Act (42 U.S.C. 1395m-1(a)(1)) is amended--
(A) in subparagraph (A), by striking ``Subject to
subparagraph (B)'' and inserting ``Subject to
subparagraphs (B) and (C)''; and
(B) by adding at the end the following new
subparagraph:
``(C) Use of statistical sampling for widely
available clinical diagnostic laboratory tests.--
``(i) In general.--Subject to clause (ii),
with respect to data collection periods for
reporting periods beginning on or after January
1, 2026, in the case of a widely available
clinical diagnostic laboratory test (as defined
in clause (iii)), in lieu of requiring the
reporting of applicable information from each
applicable laboratory, the Secretary shall
require the collection and reporting of
applicable information from a statistically
valid sample of applicable laboratories for
each such widely available clinical diagnostic
laboratory test.
``(ii) Requirements for statistical
sampling.--
``(I) In general.--The Secretary,
in consultation with stakeholders,
shall develop a methodology for a
statistically valid sample under clause
(i), using the maximal brewer selection
method, as described in the June 2021
Medicare Payment Access Commission
Report to the Congress, to establish
the payment amount for a widely
available clinical diagnostic
laboratory test under paragraph (2) of
subsection (b) for each applicable
HCPCS code for a widely available
clinical diagnostic laboratory test.
``(II) Representative sampling.--
The methodology under subclause (I) for
a statistically valid sample under
clause (i) shall, for each applicable
HCPCS code for a widely available
clinical diagnostic laboratory test--
``(aa) provide for a sample
that allows for the payment
amounts established under
paragraph (2) of subsection (b)
for such a test to be
representative of rates paid by
private payors to applicable
laboratories receiving payment
under this section, including
independent laboratories,
hospital laboratories, hospital
outreach laboratories, and
physician office laboratories
that furnish the widely
available clinical diagnostic
laboratory test;
``(bb) include applicable
information (as defined in
paragraph (3)) with respect to
such widely available clinical
diagnostic laboratory test from
such different types of
applicable laboratories; and
``(cc) be of sufficient
size to accurately and
proportionally represent the
range of private payor payment
rates received by each such
type of applicable laboratory
weighted according to the
utilization rates of each type
of applicable laboratory for
the widely available clinical
diagnostic laboratory test
during the first 6 months of
the calendar year immediately
preceding the data collection
period applicable to the sample
to be collected.
``(III) Least burdensome data
collection and reporting processes.--
The methodology developed by the
Secretary shall be designed to reduce
administrative burdens of data
collection and reporting on applicable
laboratories and the Centers for
Medicare & Medicaid Services to the
greatest extent practicable.
``(IV) Publication of list of
widely available clinical diagnostic
laboratory tests and notification to
applicable laboratories required to
report applicable information.--Not
later than September 30 of the year
immediately preceding each data
collection period (as defined in
paragraph (4)), the Secretary shall
publish in the Federal Register a list
of widely available clinical diagnostic
laboratory tests and shall directly
notify applicable laboratories required
to report applicable information under
this subsection.
``(iii) Definition of widely available
clinical diagnostic laboratory test.--In this
subparagraph, the term `widely available
clinical diagnostic laboratory test' means a
clinical diagnostic laboratory test that meets
both of the following criteria during the first
6 months of the calendar year immediately
preceding the data collection period applicable
to the sample to be collected:
``(I) Payment rate.--The payment
amount determined for the clinical
diagnostic laboratory test under this
section is less than $1,000 per test.
``(II) Number of laboratories
performing the test.--The number of
applicable laboratories receiving
payments under this section for the
clinical diagnostic laboratory test (as
determined by the Secretary using the
national provider identifier of the
provider of services or supplier on the
claim submitted for payment under this
part for such test) exceeds 100.''.
(2) Delays to revised reporting periods and reporting
period frequency.--
(A) In general.--Section 1834A(a)(1)(B) of the
Social Security Act (42 U.S.C. 1395m-1(a)(1)(B)) is
amended--
(i) in clause (i), by striking ``December
31, 2022'' and inserting ``December 31, 2024'';
(ii) in clause (ii), by striking
``beginning January 1, 2023, and ending March
31, 2023'' and inserting ``beginning January 1,
2026, and ending March 31, 2026''; and
(iii) in clause (iii) by striking ``every
three years'' and inserting ``every four
years''.
(B) Conforming change to definition of data
collection period.--Section 1834A(a)(4)(B) of the
Social Security Act (42 U.S.C. 1395m-1(a)(4)(B)) is
amended by striking ``January 1, 2019, and ending June
30, 2019'' and inserting ``January 1, 2025, and ending
June 30, 2025''.
(b) Elimination of Majority of Medicare Revenues Test.--The first
sentence of section 1834A(a)(2) of the Social Security Act (42 U.S.C.
1395m-1(a)(2)) is amended by striking ``In this section'' and all that
follows through the period and inserting the following:
``Notwithstanding determinations of applicable laboratories made prior
to January 1, 2024, the term `applicable laboratory' means a laboratory
that receives at least $12,500 in payments under this section during
the first 6 months of the calendar year immediately preceding the
applicable data collection period.''.
(c) Modifications to Applicable Information Reported.--
(1) Medicaid managed care rates.--Section 1834A(a)(8)(C) of
the Social Security Act (42 U.S.C. 1395m-1(a)(8)(C)) is amended
by striking ``A medicaid managed care organization'' and
inserting ``With respect to data collection periods for
reporting periods beginning before January 1, 2026, a medicaid
managed care organization (as defined in section 1903(m))''.
(2) Authority to exclude manual remittances.--Section
1834A(a)(3) of the Social Security Act (42 U.S.C. 1395m-
1(a)(3)) is amended--
(A) in subparagraph (A), by striking ``subject to
subparagraph (B),'' and inserting ``subject to
subparagraphs (B) and (C)''; and
(B) by adding at the end the following new
subparagraph:
``(C) Exclusion of manual remittances.--An
applicable laboratory for which less than 10 percent of
its total paid claims during a data collection period
are paid by private payors by means other than an
electronic standard transaction (as defined in section
162.103 of title 45, Code of Federal Regulations (or
any successor regulation)) may exclude from the
definition of applicable information under this
paragraph payments made by private payors that are not
made through an electronic standard transaction.''.
(d) Modification to Limits on Payment Reductions; Imposition of
Annual Cap on Payment Increases.--
(1) Payment reduction limits.--Section 1834A(b)(3) of the
Social Security Act (42 U.S.C. 1395m-1(b)(3)) is amended--
(A) in subparagraph (A), by striking ``for each of
2017 through 2025'' and inserting ``for 2017 and each
succeeding year''; and
(B) in subparagraph (B)--
(i) in clause (ii), by striking ``and'' at
the end; and
(ii) by striking clause (iii) and inserting
the following:
``(iii) for 2023, 0 percent;
``(iv) for 2024, 2.5 percent; and
``(v) for 2025 and each subsequent year, 5
percent.''.
(2) Annual cap on payment rate increases.--Section
1834A(b)(3) of the Social Security Act (42 U.S.C. 1395m-
1(b)(3)), as amended by paragraph (1), is amended--
(A) in subparagraph (A)--
(i) by striking ``test for 2017 and each
succeeding year--'' and inserting ``test--
``(i) for 2017 and each succeeding year'';
(ii) in clause (i), as added by clause (i)
of this subparagraph, by striking the period
and inserting ``; and''; and
(iii) by adding at the end the following
new clause:
``(ii) for 2023 and each succeeding year,
shall not result in an increase in payments for
a clinical diagnostic laboratory test for the
year of greater than the applicable percent (as
defined in subparagraph (D)) of the amount of
payment for the test for the preceding year.'';
(B) in subparagraph (B), in the matter preceding
clause (i), by striking ``In this paragraph'' and
inserting ``In clause (i) of subparagraph (A)''; and
(C) by adding at the end the following new
subparagraph:
``(D) Definition of applicable percent for purposes
of annual cap on payment increases.--In clause (ii) of
subparagraph (A), the term `applicable percent' means
the following:
``(i) Widely available clinical diagnostic
laboratory tests.--With respect to a widely
available clinical diagnostic laboratory test--
``(I) for 2023, 2.5 percent;
``(II) for 2024, 2.5 percent;
``(III) for 2025, 3.75 percent;
``(IV) for 2026, 3.75 percent; and
``(V) for 2027 and each subsequent
year, 5 percent.
``(ii) Other clinical diagnostic laboratory
tests.--With respect to a clinical diagnostic
laboratory test not described in clause (i), 5
percent.''.
(3) Conforming amendment.--Section 1834A(b)(3) of the
Social Security Act (42 U.S.C. 1395m-1(b)(3)) is amended in the
heading by striking ``reductions'' and inserting ``medicare
payment changes''.
(e) Regulations.--(1) Not later than December 31, 2023, the
Secretary of Health and Human Services shall implement the amendments
made by this section (other than subsection (d)) through notice and
comment rulemaking.
(2) The Secretary of Health and Human Services may implement the
amendments made by subsection (d) through interim final rulemaking,
program instruction, or otherwise.
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