[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