119-s2761

[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>