Saving Access to Laboratory Services Act

Subjects: Health, Drug safety, medical device, and laboratory regulation, Government information and archives, Health care costs and insurance, Health information and medical records, Medical tests and diagnostic methods, Medicare

Summary:  <p><b>Saving Access to Laboratory Services Act</b></p> <p>This bill modifies provisions relating to Medicare payment rates for clinical diagnostic laboratory services, including by requiring payment rates for certain widely available clinical diagnostic laboratory tests to be based on a statistical sampling of private sector rates.</p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1000 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                S. 1000

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

                             March 28, 2023

 Mr. Brown (for himself and Mr. Tillis) 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, 2023'' and inserting ``December 31, 2026'';
                            (ii) in clause (ii), by striking 
                        ``beginning January 1, 2024, and ending March 
                        31, 2024'' and inserting ``beginning January 1, 
                        2027, and ending March 31, 2027''; 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, 2026, and ending 
                June 30, 2026''.
    (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, 2025, 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, 2027, 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 2026'' and inserting ``for 2017 and each 
                succeeding year''; and
                    (B) in subparagraph (B)--
                            (i) in clause (ii)--
                                    (I) by striking ``through 2023'' 
                                and inserting ``through 2024''; and
                                    (II) by striking ``and'' at the 
                                end; and
                            (ii) by striking clause (iii) and inserting 
                        the following:
                            ``(iii) for 2025, 2.5 percent; and
                            ``(iv) for 2026 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 2024 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 each of 2024 and 2025, 
                                2.5 percent;
                                    ``(II) for each of 2026 and 2027, 
                                3.75 percent; and
                                    ``(III) for 2028 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, 2024, 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.
                                 &lt;all&gt;
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