[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2761 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 2761
To amend title XVIII of the Social Security Act to provide long-term
stability for Medicare beneficiary access to clinical diagnostic
laboratory tests by improving the accuracy of, and feasibility of data
collection for, the private payor-based fee schedule payment rates
applied under the Medicare program for such tests, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 10, 2025
Mr. Tillis (for himself and Mr. Warnock) 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 provide long-term
stability for Medicare beneficiary access to clinical diagnostic
laboratory tests by improving the accuracy of, and feasibility of data
collection for, the private payor-based fee schedule payment rates
applied under the Medicare program for such tests, 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 ``Reforming and Enhancing Sustainable
Updates to Laboratory Testing Services Act of 2025'' or the ``RESULTS
Act''.
SEC. 2. IMPROVING THE ACCURACY AND DATA COLLECTION FEASIBILITY OF THE
PRIVATE PAYOR-BASED MEDICARE PAYMENT RATES FOR CLINICAL
DIAGNOSTIC LABORATORY TESTS.
(a) Acquiring Data for Widely Available Non-Advanced Diagnostic
Laboratory Tests From a Qualifying Comprehensive Claims Database of an
Independent National Nonprofit Entity.--Section 1834A(a) of the Social
Security Act (42 U.S.C. 1395m-1(a)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) by striking ``requirements.--Subject to
subparagraph (B)'' and inserting
``requirements.--
``(i) In general.--Subject to subparagraph
(B) and except as provided for in clause
(ii)'';
(ii) in clause (i), as added by clause (i)
of this subparagraph--
(I) by striking ``paragraph (2)''
and inserting ``paragraph (2)(A)'';
(II) by inserting ``, in accordance
with the provisions of this section,''
before ``report to the Secretary'';
(III) by striking ``applicable
information (as defined in paragraph
(3)) for a data collection period (as
defined in paragraph (4))'' and
inserting ``applicable information (as
defined in paragraph (3))--
``(I) for a data collection period
(as defined in paragraph (4)) beginning
before January 1, 2027,'';
(IV) by striking the period at the
end and inserting ``; and''; and
(V) by adding at the end the
following new subclause:
``(II) for a data collection period
beginning on or after January 1, 2027,
for each clinical diagnostic laboratory
test for which final payment is made
under this part to the laboratory
during such period.''; and
(iii) by adding at the end the following
new clause;
``(ii) Collection and submission of data.--
``(I) In general.--With respect to
data collection periods for reporting
periods beginning on or after January
1, 2028, and for purposes of this
section, in the case of a widely
available non-ADLT clinical diagnostic
laboratory test (as defined in
paragraph (2)(E)), the Secretary shall
collect and use applicable information
from a qualifying comprehensive claims
database (as defined in paragraph
(2)(C)) of a qualifying independent
claims data entity (as defined in
paragraph (2)(D)) with which the
Secretary has in effect a contract
under subclause (II) for each such test
furnished during the respective data
collection period and for which final
payment is made under this part during
the year in which such data collection
period occurs.
``(II) Contract with qualifying
independent claims data entity for
access to applicable information.--As
soon as practicable after the date of
enactment of this clause, the Secretary
shall identify and enter into a
contract with a qualifying independent
claims data entity for the purpose of,
with respect to widely available non-
ADLT clinical diagnostic laboratory
tests furnished during a data
collection period, such entity
reporting to the Secretary applicable
information from a qualifying
comprehensive claims database of the
entity for such tests for which final
payment is made under this part during
the year in which such data collection
period occurs and for which there is
applicable information within such
database for such period.''.
(B) in subparagraph (B)--
(i) in clause (i), by striking ``2025'' and
inserting ``2027'';
(ii) in clause (ii), by striking
``beginning January 1, 2026, and ending March
31, 2026'' and inserting ``beginning January 1,
2028, and ending March 31, 2028''; and
(iii) in clause (iii), by striking ``three
years'' and inserting ``4 years''; and
(2) in paragraph (2)--
(A) by striking ``Definition of applicable
laboratory.--In this section, the term `applicable
laboratory' means'' and inserting ``Definitions.--In
this section:''
``(A) Applicable laboratory.--
``(i) Reporting periods before 2028.--With
respect to reporting periods beginning before
January 1, 2028, the term `applicable
laboratory' means'';
(B) in subparagraph (A), as inserted by
subparagraph (A) of this paragraph--
(i) in clause (i), in the second sentence,
by striking ``paragraph'' and inserting
``clause''; and
(ii) by adding at the end the following new
clause:
``(ii) Reporting periods beginning during
2028 and subsequent years.--With respect to
reporting periods beginning on or after January
1, 2028, the term `applicable laboratory' shall
have the meaning given such term in section
414.502 of title 42, Code of Federal
Regulations, as in effect on May 1, 2025,
except without application of paragraph (3) of
such section.''; and
(C) by adding at the end the following new
subparagraphs:
``(B) Non-widely available non-adlt clinical
diagnostic laboratory test.--The term `non-widely
available non-ADLT clinical diagnostic laboratory test'
means, with respect to a reporting period, a clinical
diagnostic laboratory test that is not an advanced
diagnostic laboratory test and that is not described in
subparagraph (E).
``(C) Qualifying independent claims data entity.--
The term `qualifying independent claims data entity'
means an entity that satisfies each of the following
criteria:
``(i) The entity is a national nonprofit
organization that is not affiliated with any
Government agency, insurance issuer, group
health plan, provider of services or supplier,
or other organization in the health care
sector.
``(ii) The entity collects data and
maintains a qualifying comprehensive claims
database (as defined in subparagraph (D)).
``(iii) The entity is certified by the
Secretary to be a qualified entity (as defined
in paragraph (2) of section 1874(e)) with
respect to having access to data described in
paragraph (3) of such section.
``(iv) The entity, with respect to all data
included in the qualifying comprehensive claims
database of the entity, complies with all
applicable Federal and State privacy and
security requirements, including HIPAA privacy
and security law (as defined in section 3009 of
the Public Health Service Act).
``(v) The entity applies quality assurance
processes to validate all data that is included
in the qualifying comprehensive claims database
of the entity, including comprehensive
statistical testing.
``(D) Qualifying comprehensive claims database.--
The term `qualifying comprehensive claims database'
means an independent database of private payor claims
data, which--
``(i) includes at least 50,000,000,000
claims from more than 50 private payors and
claims administrators;
``(ii) is a statistically significant
repository of claims data that is
representative for all 50 States and the
District of Columbia;
``(iii) includes only data that is
validated by quality assurance processes,
including comprehensive statistical testing;
``(iv) complies with all applicable Federal
and State privacy and security requirements, as
described in subparagraph (C)(iv);
``(v) provides for version control of
claims to enable the collation and submission,
for purposes of this section, of only claims
representative of final payment amounts; and
``(vi) includes claims data with respect to
widely available non-ADLT clinical diagnostic
laboratory tests.
``(E) Widely available non-adlt clinical diagnostic
laboratory test.--The term `widely available non-ADLT
clinical diagnostic laboratory test' means, with
respect to a reporting period, a clinical diagnostic
laboratory test that is not an advanced diagnostic
laboratory test and for which, during the first 6
months of the year immediately preceding the data
collection period for such reporting period, the number
of providers of services and suppliers receiving
payments under this section (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.'';
(3) in paragraph (5)--
(A) by inserting ``final'' after ``The''; and
(B) by inserting ``or from a qualifying
comprehensive claims database pursuant to paragraph
(1)(A)(ii)'' after ``reported by a laboratory under
this subsection'';
(4) in paragraph (6)--
(A) by inserting ``(or, with respect to a widely
available non-ADLT clinical diagnostic laboratory test,
the qualifying comprehensive claims database of the
qualifying independent claims data entity with a
contract under paragraph (1)(A)(ii))'' after ``In the
case where an applicable laboratory'';
(B) by striking ``payment rate'' each place it
appears and inserting ``final payment rate'';
(C) by inserting ``(and such different payment
rates do not relate to the same claim)'' after ``for
the same payor for the same test''; and
(D) by inserting ``or qualifying independent claims
data entity, as applicable,'' after ``the applicable
laboratory'';
(5) in paragraph (9)(A), by inserting ``required to be
reported by such laboratory'' after ``in reporting
information'';
(6) in paragraph (10)--
(A) by striking ``by a laboratory'' after
``information disclosed''; and
(B) by inserting ``by a laboratory or the
qualifying independent claims data entity with a
contract under paragraph (1)(A)(ii)'' after ``under
this subsection''; and
(7) in paragraph (12)--
(A) by striking ``Regulations.--Not later than June
30, 2015,'' and inserting ``Regulations.--
``(A) For data collection periods before 2027.--Not
later than June 30, 2015, for data collection periods
beginning before January 1, 2027,''; and
(B) by adding at the end the following new
subparagraph:
``(B) For data collection periods beginning with
2027.--Not later than December 31, 2026, the Secretary
shall establish through notice and comment rulemaking
parameters for data collection periods beginning on or
after January 1, 2027.''.
(b) Incorporating Data Collection Improvements Into Private Payor-
Based Medicare Payment Rates for Clinical Diagnostic Laboratory Tests
That Are Not Advanced Diagnostic Laboratory Tests.--
(1) Calculation of weighted median of private payor-based
rates.--Section 1834A(b)(2) of the Social Security Act (42
U.S.C. 1395m-1(b)(2)) is amended--
(A) by inserting ``and, in the case of widely
available non-ADLT clinical diagnostic laboratory
tests, with respect to data collection periods for
reporting periods beginning on or after January 1,
2028, for each such test furnished by an applicable
laboratory with respect to which there is applicable
information made available to the Secretary pursuant to
paragraph (1)(A)(ii) of such subsection'' after ``under
subsection (a) for a data collection period''; and
(B) by inserting ``final'' before ``payment rates
reported''.
(2) Default adjustment in cases of widely available non-
adlt clinical diagnostic laboratory tests for periods for which
there is no contract with a qualifying independent claims
entity or no applicable information in the qualifying
comprehensive claims database.--Section 1834A(b) of the Social
Security Act (42 U.S.C. 1395m-1(b)) is amended--
(A) in paragraph (1)(A), by striking ``paragraph
(3)'' and inserting ``paragraphs (3) and (6)''; and
(B) by adding at the end the following new
paragraph:
``(6) Default payment for widely available non-adlt
clinical diagnostic laboratory tests for periods for which
there is no contract with an independent entity or with respect
to which there is no data.--
``(A) In general.--With respect to data collection
periods for reporting periods beginning on or after
January 1, 2028, in the case of a widely available non-
ADLT clinical diagnostic laboratory test with respect
to which subsection (c) does not apply, if a
circumstance described in subparagraph (B) applies with
respect to such a reporting period and such a clinical
diagnostic laboratory test, payment for such test under
this section for a year beginning during the qualified
rate period described in subparagraph (C), shall be
equal to the amount of payment for such clinical
diagnostic laboratory test under this section for the
previous year, increased by the percentage increase in
the Consumer Price Index for all urban consumers (all
items; United States city average) over the previous
year.
``(B) Circumstances described.--For purposes of
subparagraph (A), with respect to a data collection
period and a widely available non-ADLT clinical
diagnostic laboratory test, the circumstances described
in this subparagraph are if the Secretary--
``(i) is not able to enter into a contract
under subsection (a)(1)(A)(ii) with a
qualifying independent claims data entity with
respect to such data collection period; or
``(ii) determines that there is no
applicable information with respect to such
clinical diagnostic laboratory test and data
collection period in the qualifying
comprehensive claims database of such
qualifying independent claims data entity.
``(C) Qualified rate period described.--For
purposes of subparagraph (A), the qualified rate
period, with respect to a data collection period and a
widely available non-ADLT clinical diagnostic test to
which a circumstance described in subparagraph (B)
applies, is the period--
``(i) beginning on the first day of the
second year following the first data collection
period with respect to which such circumstance
applies with respect to such test; and
``(ii) ending with the last day of the year
following the first data collection period with
respect to which such circumstance no longer
applies with respect to such test.''.
(3) Payment in cases in which there is no reported
applicable information for non-widely available non-adlts.--
Section 1834A of the Social Security Act (42 U.S.C. 1395m-1),
is amended--
(A) in subsection (b), as amended by paragraph
(2)--
(i) in paragraph (1)(A), by striking
``paragraphs (3) and (6)'' and inserting
``paragraphs (3), (6), and (7)''; and
(ii) by adding at the end the following new
paragraph:
``(7) Payment for non-widely available non-adlt clinical
diagnostic laboratory tests for which there is no applicable
information.--
``(A) In general.--For determining payment under
this subsection for a year in the case of a non-widely
available non-ADLT clinical diagnostic laboratory test
with respect to which subsection (c) does not apply, if
the Secretary determines that no applicable information
has been reported under subsection (a)(1)(A)(i) by any
applicable laboratory for such test with respect to the
most recent data collection period (beginning with data
collection periods for reporting periods beginning on
or after January 1, 2028), payment for such test under
this section for such year shall be determined as
follows:
``(i) In the case that a process described
in subparagraph (B) was not applied pursuant to
this subparagraph for determining payment for
such test for a previous year with respect to
such data collection period, payment for such
test and year shall be determined using such a
process.
``(ii) In the case that a process described
in subparagraph (B) was applied pursuant to
this subparagraph for determining payment for
such test for a previous year with respect to
such data collection period, payment for such
test and year shall be equal to the amount of
payment for such test under this section for
the previous year.
``(B) Process described.--For purposes of
subparagraph (A), a process described in this
subparagraph, with respect to a non-widely available
non-ADLT clinical diagnostic laboratory test for which
there is no reported data (as described in such
subparagraph) with respect to a data collection period,
is--
``(i) cross-walking (as described in
section 414.508(a) of title 42, Code of Federal
Regulations, or any successor regulation) to
the most appropriate clinical diagnostic
laboratory test under the fee schedule under
this section during that period; or
``(ii) if no other clinical diagnostic
laboratory test is comparable to the test for
which there is no reported applicable
information, according to the gapfilling
process described in subsection (c)(2).''; and
(B) in subsection (c)(3), by inserting ``or
subsection (b)(7)'' after ``under this subsection''.
(4) Publicly available explanation of payment rates.--
Section 1834A(b) of the Social Security Act (42 U.S.C. 1395m-
1(b)), as amended by paragraphs (2) and (3)(A), is amended by
adding at the end the following new paragraph:
``(8) Explanation of payment rates.--In the case of a
clinical diagnostic laboratory test for which payment is made
under this subsection, the Secretary shall make available to
the public an explanation of the payment rate for such test,
including any supporting data as may be necessary for a
laboratory to assess the accuracy of the calculations.''.
(5) Technical correction clarifying period of application
of market rates.--Section 1834A(b)(4)(A) of the Social Security
Act (42 U.S.C. 1395m-1(b)(4)(A)) is amended by striking ``until
the year following'' and inserting ``through the year
following''.
(c) Additional Improvements To Ensure Updated, Accurate Market-
Based Data for Clinical Diagnostic Laboratory Tests.--
(1) Updates to applicable information to better reflect
final payment rates.--Section 1834A(a)(3) of the Social
Security Act (42 U.S.C. 1395m-1(a)(3)) is amended--
(A) in the heading, by inserting ``and final
payment rate'' after ``information'';
(B) in subparagraph (A)--
(i) in the heading, by striking ``In
general'' and inserting ``Data collection
periods before january 1, 2027''; and
(ii) in the matter preceding clause (i)--
(I) by striking ``subparagraph
(B)'' and inserting ``subparagraph
(C)''; and
(II) by inserting ``beginning
before January 1, 2027'' after ``for a
data collection period'';
(C) by redesignating subparagraph (B) as
subparagraph (C);
(D) by inserting after subparagraph (A) the
following new subparagraph:
``(B) Subsequent data collection periods.--In this
section, subject to subparagraph (C), for a data
collection period beginning on or after January 1,
2027, the term `applicable information' means--
``(i) with respect to a widely available
non-ADLT clinical diagnostic laboratory test
furnished during such period--
``(I) the final payment rate (as
determined in accordance with paragraph
(5) and defined in subparagraph (D))
that was paid by each private payor for
the test during the year in which such
period occurs; and
``(II) the volume, for each such
payor, of such test for which final
payment was made during such year; and
``(ii) with respect to a non-widely
available non-ADLT clinical diagnostic
laboratory test or an advanced diagnostic
laboratory test--
``(I) the final payment rate (as
determined in accordance with paragraph
(5) and defined in subparagraph (D))
that was paid by each private payor for
the test during the data collection
period; and
``(II) the volume, for each such
payor, of such test for which final
payment was made during such period.'';
and
(E) by inserting after subparagraph (C), the
following new subparagraph:
``(D) Final payment rate.--In this section, for a
data collection period beginning on or after January 1,
2027, the term `final payment rate'--
``(i) means--
``(I) with respect to a widely
available non-ADLT clinical diagnostic
laboratory test furnished during a data
collection period, the last payment
made for a test during the year in
which the data collection period
occurs; and
``(II) with respect to a non-widely
available non-ADLT clinical diagnostic
laboratory test or an advanced
diagnostic laboratory test paid during
a data collection period, the last
payment made during the data collection
period; and
``(ii) does not include--
``(I) denied payments;
``(II) payments under appeal or
under review by the private payor;
``(III) payments made in error; or
``(IV) payments that are recouped
by the private payor.''.
(2) Updating data collection periods.--Section
1834A(a)(4)(B) of the Social Security Act (42 U.S.C. 1395m-
1(a)(4)(B)) is amended--
(A) by striking ``January 1, 2019'' and inserting
``January 1, 2027'';
(B) by striking ``June 30, 2019'' and inserting
``June 30, 2027''; and
(C) by adding at the end the following new
sentence: ``In the case of the reporting period after
the reporting period described in paragraph (1)(B)(ii)
and each subsequent reporting period with respect to
clinical diagnostic laboratory tests that are not
advanced diagnostic laboratory tests, the term `data
collection period' means the 6-month period beginning
January 1st of the year preceding the year during which
such reporting period begins.''.
(3) Ensuring data is market-based by excluding rates of
medicaid managed care organizations.--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, 2028, a medicaid
managed care organization.''.
(4) Modifications to limits on payment reductions.--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 ``each of 2017
through 2028'' and inserting ``2017 and each subsequent
year'';
(B) in subparagraph (B)--
(i) in clause (ii), by striking ``2025''
and inserting ``2028''; and
(ii) in clause (iii), by striking ``for
each of 2026 through 2028, 15 percent'' and
inserting ``for 2029 and each subsequent year,
5 percent''; and
(C) in subparagraph (C)(ii), by inserting
``laboratory'' after ``advanced diagnostic''.
(5) Sunsetting review limitations.--Section 1834A(h)(1) of
the Social Security Act (42 U.S.C. 1395m-1(h)(1)) is amended by
inserting ``before January 1, 2029'' before the period at the
end.
<all>