II 

117TH CONGRESS 

2D SESSION S. 4449 

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 

JUNE 22, 2022 

Mr. BURR (for himself and Mr. BROWN) 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Saving Access to Lab5 oratory Services Act’’. 


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1 SEC. 2. MODIFICATION OF REQUIREMENTS FOR MEDICARE 

2 CLINICAL DIAGNOSTIC LABORATORY TESTS. 

3 (a) USE OF STATISTICAL SAMPLING FOR WIDELY

4 AVAILABLE CLINICAL DIAGNOSTIC LABORATORY

5 TESTS.— 

6 (1) IN GENERAL.—Section 1834A(a)(1) of the 

7 Social Security Act (42 U.S.C. 1395m–1(a)(1)) is 

8 amended— 

9 (A) in subparagraph (A), by striking ‘‘Sub10 ject to subparagraph (B)’’ and inserting ‘‘Sub11 ject to subparagraphs (B) and (C)’’; and 

12 (B) by adding at the end the following new 

13 subparagraph: 

14 ‘‘(C) USE OF STATISTICAL SAMPLING FOR

15 WIDELY AVAILABLE CLINICAL DIAGNOSTIC LAB16 ORATORY TESTS.— 

17 ‘‘(i) IN GENERAL.—Subject to clause 

18 (ii), with respect to data collection periods 

19 for reporting periods beginning on or after 

20 January 1, 2026, in the case of a widely 

21 available clinical diagnostic laboratory test 

22 (as defined in clause (iii)), in lieu of re23 quiring the reporting of applicable infor24 mation from each applicable laboratory, 

25 the Secretary shall require the collection 

26 and reporting of applicable information 


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1 from a statistically valid sample of applica2 ble laboratories for each such widely avail3 able clinical diagnostic laboratory test. 

4 ‘‘(ii) REQUIREMENTS FOR STATIS5 TICAL SAMPLING.— 

6 ‘‘(I) IN GENERAL.—The Sec7 retary, in consultation with stake8 holders, shall develop a methodology 

9 for a statistically valid sample under 

10 clause (i), using the maximal brewer 

11 selection method, as described in the 

12 June 2021 Medicare Payment Access 

13 Commission Report to the Congress, 

14 to establish the payment amount for a 

15 widely available clinical diagnostic lab16 oratory test under paragraph (2) of 

17 subsection (b) for each applicable 

18 HCPCS code for a widely available 

19 clinical diagnostic laboratory test. 

20 ‘‘(II) REPRESENTATIVE SAM21 PLING.—The methodology under sub22 clause (I) for a statistically valid sam23 ple under clause (i) shall, for each ap24 plicable HCPCS code for a widely 


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1 available clinical diagnostic laboratory 

2 test— 

3 ‘‘(aa) provide for a sample 

4 that allows for the payment 

5 amounts established under para6 graph (2) of subsection (b) for 

7 such a test to be representative 

8 of rates paid by private payors to 

9 applicable laboratories receiving 

10 payment under this section, in11 cluding independent laboratories, 

12 hospital laboratories, hospital 

13 outreach laboratories, and physi14 cian office laboratories that fur15 nish the widely available clinical 

16 diagnostic laboratory test; 

17 ‘‘(bb) include applicable in18 formation (as defined in para19 graph (3)) with respect to such 

20 widely available clinical diag21 nostic laboratory test from such 

22 different types of applicable lab23 oratories; and 

24 ‘‘(cc) be of sufficient size to 

25 accurately and proportionally 


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1 represent the range of private 

2 payor payment rates received by 

3 each such type of applicable lab4 oratory weighted according to the 

5 utilization rates of each type of 

6 applicable laboratory for the 

7 widely available clinical diag8 nostic laboratory test during the 

9 first 6 months of the calendar 

10 year immediately preceding the 

11 data collection period applicable 

12 to the sample to be collected. 

13 ‘‘(III) LEAST BURDENSOME DATA

14 COLLECTION AND REPORTING PROC15 ESSES.—The methodology developed 

16 by the Secretary shall be designed to 

17 reduce administrative burdens of data 

18 collection and reporting on applicable 

19 laboratories and the Centers for Medi20 care & Medicaid Services to the great21 est extent practicable. 

22 ‘‘(IV) PUBLICATION OF LIST OF

23 WIDELY AVAILABLE CLINICAL DIAG24 NOSTIC LABORATORY TESTS AND NO25 TIFICATION TO APPLICABLE LABORAVerDate Sep 11 2014 17:24 Jun 24, 2022 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4449.IS S4449

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1 TORIES REQUIRED TO REPORT APPLI2 CABLE INFORMATION.—Not later than 

3 September 30 of the year immediately 

4 preceding each data collection period 

5 (as defined in paragraph (4)), the 

6 Secretary shall publish in the Federal 

7 Register a list of widely available clin8 ical diagnostic laboratory tests and 

9 shall directly notify applicable labora10 tories required to report applicable in11 formation under this subsection. 

12 ‘‘(iii) DEFINITION OF WIDELY AVAIL13 ABLE CLINICAL DIAGNOSTIC LABORATORY

14 TEST.—In this subparagraph, the term 

15 ‘widely available clinical diagnostic labora16 tory test’ means a clinical diagnostic lab17 oratory test that meets both of the fol18 lowing criteria during the first 6 months of 

19 the calendar year immediately preceding 

20 the data collection period applicable to the 

21 sample to be collected: 

22 ‘‘(I) PAYMENT RATE.—The pay23 ment amount determined for the clin24 ical diagnostic laboratory test under 


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1 this section is less than $1,000 per 

2 test. 

3 ‘‘(II) NUMBER OF LABORATORIES

4 PERFORMING THE TEST.—The num5 ber of applicable laboratories receiving 

6 payments under this section for the 

7 clinical diagnostic laboratory test (as 

8 determined by the Secretary using the 

9 national provider identifier of the pro10 vider of services or supplier on the 

11 claim submitted for payment under 

12 this part for such test) exceeds 100.’’. 

13 (2) DELAYS TO REVISED REPORTING PERIODS

14 AND REPORTING PERIOD FREQUENCY.— 

15 (A) IN GENERAL.—Section 

16 1834A(a)(1)(B) of the Social Security Act (42 

17 U.S.C. 1395m–1(a)(1)(B)) is amended— 

18 (i) in clause (i), by striking ‘‘Decem19 ber 31, 2022’’ and inserting ‘‘December 

20 31, 2024’’; 

21 (ii) in clause (ii), by striking ‘‘begin22 ning January 1, 2023, and ending March 

23 31, 2023’’ and inserting ‘‘beginning Janu24 ary 1, 2026, and ending March 31, 2026’’; 

25 and 


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1 (iii) in clause (iii) by striking ‘‘every 

2 three years’’ and inserting ‘‘every four 

3 years’’. 

4 (B) CONFORMING CHANGE TO DEFINITION

5 OF DATA COLLECTION PERIOD.—Section 

6 1834A(a)(4)(B) of the Social Security Act (42 

7 U.S.C. 1395m–1(a)(4)(B)) is amended by strik8 ing ‘‘January 1, 2019, and ending June 30, 

9 2019’’ and inserting ‘‘January 1, 2025, and 

10 ending June 30, 2025’’. 

11 (b) ELIMINATION OF MAJORITY OF MEDICARE REVE12 NUES TEST.—The first sentence of section 1834A(a)(2) 

13 of the Social Security Act (42 U.S.C. 1395m–1(a)(2)) is 

14 amended by striking ‘‘In this section’’ and all that follows 

15 through the period and inserting the following: ‘‘Notwith16 standing determinations of applicable laboratories made 

17 prior to January 1, 2024, the term ‘applicable laboratory’ 

18 means a laboratory that receives at least $12,500 in pay19 ments under this section during the first 6 months of the 

20 calendar year immediately preceding the applicable data 

21 collection period.’’. 

22 (c) MODIFICATIONS TO APPLICABLE INFORMATION

23 REPORTED.— 

24 (1) MEDICAID MANAGED CARE RATES.—Section 

25 1834A(a)(8)(C) of the Social Security Act (42 


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1 U.S.C. 1395m–1(a)(8)(C)) is amended by striking 

2 ‘‘A medicaid managed care organization’’ and insert3 ing ‘‘With respect to data collection periods for re4 porting periods beginning before January 1, 2026, a 

5 medicaid managed care organization (as defined in 

6 section 1903(m))’’. 

7 (2) AUTHORITY TO EXCLUDE MANUAL REMIT8 TANCES.—Section 1834A(a)(3) of the Social Secu9 rity Act (42 U.S.C. 1395m–1(a)(3)) is amended— 

10 (A) in subparagraph (A), by striking ‘‘sub11 ject to subparagraph (B),’’ and inserting ‘‘sub12 ject to subparagraphs (B) and (C)’’; and 

13 (B) by adding at the end the following new 

14 subparagraph: 

15 ‘‘(C) EXCLUSION OF MANUAL REMIT16 TANCES.—An applicable laboratory for which 

17 less than 10 percent of its total paid claims 

18 during a data collection period are paid by pri19 vate payors by means other than an electronic 

20 standard transaction (as defined in section 

21 162.103 of title 45, Code of Federal Regula22 tions (or any successor regulation)) may exclude 

23 from the definition of applicable information 

24 under this paragraph payments made by private 


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1 payors that are not made through an electronic 

2 standard transaction.’’. 

3 (d) MODIFICATION TO LIMITS ON PAYMENT REDUC4 TIONS; IMPOSITION OF ANNUAL CAP ON PAYMENT IN5 CREASES.— 

6 (1) PAYMENT REDUCTION LIMITS.—Section 

7 1834A(b)(3) of the Social Security Act (42 U.S.C. 

8 1395m–1(b)(3)) is amended— 

9 (A) in subparagraph (A), by striking ‘‘for 

10 each of 2017 through 2025’’ and inserting ‘‘for 

11 2017 and each succeeding year’’; and 

12 (B) in subparagraph (B)— 

13 (i) in clause (ii), by striking ‘‘and’’ at 

14 the end; and 

15 (ii) by striking clause (iii) and insert16 ing the following: 

17 ‘‘(iii) for 2023, 0 percent; 

18 ‘‘(iv) for 2024, 2.5 percent; and 

19 ‘‘(v) for 2025 and each subsequent 

20 year, 5 percent.’’. 

21 (2) ANNUAL CAP ON PAYMENT RATE IN22 CREASES.—Section 1834A(b)(3) of the Social Secu23 rity Act (42 U.S.C. 1395m–1(b)(3)), as amended by 

24 paragraph (1), is amended— 

25 (A) in subparagraph (A)— 


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1 (i) by striking ‘‘test for 2017 and 

2 each succeeding year—’’ and inserting 

3 ‘‘test— 

4 ‘‘(i) for 2017 and each succeeding 

5 year’’; 

6 (ii) in clause (i), as added by clause 

7 (i) of this subparagraph, by striking the 

8 period and inserting ‘‘; and’’; and 

9 (iii) by adding at the end the fol10 lowing new clause: 

11 ‘‘(ii) for 2023 and each succeeding 

12 year, shall not result in an increase in pay13 ments for a clinical diagnostic laboratory 

14 test for the year of greater than the appli15 cable percent (as defined in subparagraph 

16 (D)) of the amount of payment for the test 

17 for the preceding year.’’; 

18 (B) in subparagraph (B), in the matter 

19 preceding clause (i), by striking ‘‘In this para20 graph’’ and inserting ‘‘In clause (i) of subpara21 graph (A)’’; and 

22 (C) by adding at the end the following new 

23 subparagraph: 

24 ‘‘(D) DEFINITION OF APPLICABLE PER25 CENT FOR PURPOSES OF ANNUAL CAP ON PAYVerDate Sep 11 2014 16:56 Jun 25, 2022 Jkt 029200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S4449.IS S4449

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1 MENT INCREASES.—In clause (ii) of subpara2 graph (A), the term ‘applicable percent’ means 

3 the following: 

4 ‘‘(i) WIDELY AVAILABLE CLINICAL DI5 AGNOSTIC LABORATORY TESTS.—With re6 spect to a widely available clinical diag7 nostic laboratory test— 

8 ‘‘(I) for 2023, 2.5 percent; 

9 ‘‘(II) for 2024, 2.5 percent; 

10 ‘‘(III) for 2025, 3.75 percent; 

11 ‘‘(IV) for 2026, 3.75 percent; 

12 and 

13 ‘‘(V) for 2027 and each subse14 quent year, 5 percent. 

15 ‘‘(ii) OTHER CLINICAL DIAGNOSTIC

16 LABORATORY TESTS.—With respect to a 

17 clinical diagnostic laboratory test not de18 scribed in clause (i), 5 percent.’’. 

19 (3) CONFORMING AMENDMENT.—Section 

20 1834A(b)(3) of the Social Security Act (42 U.S.C. 

21 1395m–1(b)(3)) is amended in the heading by strik22 ing ‘‘REDUCTIONS’’ and inserting ‘‘MEDICARE PAY23 MENT CHANGES’’. 

24 (e) REGULATIONS.—(1) Not later than December 31, 

25 2023, the Secretary of Health and Human Services shall 


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1 implement the amendments made by this section (other 

2 than subsection (d)) through notice and comment rule3 making. 

4 (2) The Secretary of Health and Human Services 

5 may implement the amendments made by subsection (d) 

6 through interim final rulemaking, program instruction, or 

7 otherwise. 

Æ 


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