RESULTS Act · Introduced in House (2025-09-10)

119th CONGRESS 1st Session

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 HOUSE OF REPRESENTATIVES · September 10, 2025 · Sponsor: Mr. Hudson

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 () is amended— 42 U.S.C. 1395m–1(a)
- in paragraph (1)—
  - in subparagraph (A)—
    - (i) by striking and inserting
      - .—
        
        (i) Subject to subparagraph (B) and except as provided for in clause (ii)
    - (ii) in clause (i), as added by clause (i) of this subparagraph—
    - by striking paragraph (2)and inserting paragraph (2)(A);
    - by inserting before ;
    - by striking and inserting
      - applicable information (as defined in paragraph (3))—
      - for a data collection period (as defined in paragraph (4)) beginning before January 1, 2027,
    - by striking the period at the end and inserting ; and; and
      - 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.
    - by adding at the end the following new subclause:
    - (iii) by adding at the end the following new clause;
      - (ii) Collection and submission of data
        
        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.
        
        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.
  - in subparagraph (B)—
    - (i) in clause (i), by striking and inserting ;
    - (ii) in clause (ii), by striking beginning January 1, 2026, and ending March 31, 2026and inserting beginning January 1, 2028, and ending March 31, 2028; and
    - (iii) in clause (iii), by striking three yearsand inserting 4 years;
- in paragraph (2)—
  - by striking and inserting
    - (A) Applicable laboratory
      - (i) With respect to reporting periods beginning before January 1, 2028, the term applicable laboratory means
  - in subparagraph (A), as inserted by subparagraph (A) of this paragraph—
    - (i) in clause (i), in the second sentence, by striking paragraphand inserting clause; and
    - (ii) by adding at the end the following new clause:
      - (ii) With respect to reporting periods beginning on or after January 1, 2028, the term 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. applicable laboratory
    - (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;
- in paragraph (5)—
  - by inserting after ; and
  - by inserting after ;
- in paragraph (6)—
  - by inserting after ;
  - by striking each place it appears and inserting final payment rate;
  - by inserting after ; and
  - by inserting after ;
- in paragraph (9)(A), by inserting after ;
- in paragraph (10)—
  - by striking after ; and
  - by inserting after ; and
- in paragraph (12)—
  - by striking and inserting
    - .—
    - (A) For data collection periods before 2027
      - Not later than June 30, 2015, for data collection periods beginning before January 1, 2027,
    - (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.
  - by adding at the end the following new subparagraph:

(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 () is amended— 42 U.S.C. 1395m–1(b)(2)
  - by inserting after ; and
  - by inserting before .
(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 () is amended— 42 U.S.C. 1395m–1(b)
  - in paragraph (1)(A), by striking paragraph (3)and inserting paragraphs (3) and (6); and
    - (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—

(1) Updates to applicable information to better reflect final payment rates
- Section 1834A(a)(3) of the Social Security Act () is amended— 42 U.S.C. 1395m–1(a)(3)
  - in the heading, by inserting after ;
  - in subparagraph (A)—
    - (i) in the heading, by striking and inserting ; and
    - (ii) in the matter preceding clause (i)—
    - by striking subparagraph (B)and inserting subparagraph (C); and
    - by inserting after ;
  - by redesignating subparagraph (B) as subparagraph (C);
    - (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—
        
        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
        
        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—
        
        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
        
        the volume, for each such payor, of such test for which final payment was made during such period.
  - by inserting after subparagraph (A) 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—
        
        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
        
        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—
        
        denied payments;
        
        payments under appeal or under review by the private payor;
        
        payments made in error; or
        
        payments that are recouped by the private payor.
  - by inserting after subparagraph (C), the following new subparagraph:

H.R. 5269

Table of contents

SEC. 1. Short title

SEC. 2. Improving the accuracy and data collection feasibility of the private payor-based Medicare payment rates for clinical diagnostic laboratory tests