I 
117TH CONGRESS 
2D SESSION 
H. R. 8188 
To amend title XVIII of the Social Security Act to improve the accuracy 
of market-based Medicare payment for clinical diagnostic laboratory serv-
ices, to reduce administrative burdens in the collection of data, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 22, 2022 
Mr. PASCRELL (for himself, Mr. PETERS, Mr. HUDSON, Mr. SCHRADER, and 
Mr. BILIRAKIS) introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committee 
on Ways and Means, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to improve 
the accuracy of market-based Medicare payment for clin-
ical diagnostic laboratory services, to reduce administra-
tive burdens in the collection of data, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Saving Access to Lab-
oratory Services Act’’. 
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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 ‘‘Sub-
ject to subparagraph (B)’’ and inserting ‘‘Sub-
ject 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 LAB-
ORATORY 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 re-
quiring the reporting of applicable infor-
mation from each applicable laboratory, 
the Secretary shall require the collection 
and reporting of applicable information 
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from a statistically valid sample of applica-
ble laboratories for each such widely avail-
able clinical diagnostic laboratory test. 
‘‘(ii) REQUIREMENTS
FOR
STATIS-
TICAL SAMPLING.— 
‘‘(I) IN
GENERAL.—The Sec-
retary, in consultation with stake-
holders, 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 lab-
oratory test under paragraph (2) of 
subsection (b) for each applicable 
HCPCS code for a widely available 
clinical diagnostic laboratory test. 
‘‘(II) 
REPRESENTATIVE
SAM-
PLING.—The methodology under sub-
clause (I) for a statistically valid sam-
ple under clause (i) shall, for each ap-
plicable HCPCS code for a widely 
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available clinical diagnostic laboratory 
test— 
‘‘(aa) provide for a sample 
that allows for the payment 
amounts established under para-
graph (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, in-
cluding independent laboratories, 
hospital 
laboratories, 
hospital 
outreach laboratories, and physi-
cian office laboratories that fur-
nish the widely available clinical 
diagnostic laboratory test; 
‘‘(bb) include applicable in-
formation (as defined in para-
graph (3)) with respect to such 
widely available clinical diag-
nostic laboratory test from such 
different types of applicable lab-
oratories; and 
‘‘(cc) be of sufficient size to 
accurately 
and 
proportionally 
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represent the range of private 
payor payment rates received by 
each such type of applicable lab-
oratory weighted according to the 
utilization rates of each type of 
applicable 
laboratory 
for 
the 
widely available clinical diag-
nostic 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
PROC-
ESSES.—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 Medi-
care & Medicaid Services to the great-
est extent practicable. 
‘‘(IV) PUBLICATION OF LIST OF 
WIDELY
AVAILABLE
CLINICAL
DIAG-
NOSTIC LABORATORY TESTS AND NO-
TIFICATION TO APPLICABLE LABORA-
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TORIES REQUIRED TO REPORT APPLI-
CABLE 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 clin-
ical diagnostic laboratory tests and 
shall directly notify applicable labora-
tories required to report applicable in-
formation under this subsection. 
‘‘(iii) DEFINITION OF WIDELY AVAIL-
ABLE CLINICAL DIAGNOSTIC LABORATORY 
TEST.—In this subparagraph, the term 
‘widely available clinical diagnostic labora-
tory test’ means a clinical diagnostic lab-
oratory test that meets both of the fol-
lowing 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 pay-
ment amount determined for the clin-
ical diagnostic laboratory test under 
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this section is less than $1,000 per 
test. 
‘‘(II) NUMBER OF LABORATORIES 
PERFORMING THE TEST.—The num-
ber 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 pro-
vider 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 ‘‘Decem-
ber 31, 2022’’ and inserting ‘‘December 
31, 2024’’; 
(ii) in clause (ii), by striking ‘‘begin-
ning January 1, 2023, and ending March 
31, 2023’’ and inserting ‘‘beginning Janu-
ary 1, 2026, and ending March 31, 2026’’; 
and 
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(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 strik-
ing ‘‘January 1, 2019, and ending June 30, 
2019’’ and inserting ‘‘January 1, 2025, and 
ending June 30, 2025’’. 
(b) ELIMINATION OF MAJORITY OF MEDICARE REVE-
NUES 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: ‘‘Notwith-
standing determinations of applicable laboratories made 
prior to January 1, 2024, the term ‘applicable laboratory’ 
means a laboratory that receives at least $12,500 in pay-
ments 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 
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