What This Bill Does
This bill modifies how Medicare pays for clinical diagnostic laboratory tests (blood tests and similar medical lab work). It allows the government to collect payment information from a sample of labs instead of all labs. The bill also changes payment reduction limits and adds caps on payment increases for these services.
Who It Affects
Clinical diagnostic laboratories including independent labs, hospital labs, hospital outreach labs and physician office labs that perform diagnostic tests and receive Medicare payments. The Centers for Medicare and Medicaid Services (the federal agency that runs Medicare).
Key Provisions
• Starting with data collection periods beginning January 1, 2026, the government can collect payment information from a statistically valid sample of labs instead of requiring all labs to report, but only for widely available clinical diagnostic laboratory tests (Sec. 2(a)(1)).
• The government must use the maximal brewer selection method to develop this sampling methodology, with input from stakeholders, to make sure the sample accurately represents different types of labs and their payment rates (Sec. 2(a)(1)(C)(ii)(I) and (II)).
• Labs with less than 10 percent of claims paid electronically during a data collection period can exclude manual payment information from what they report (Sec. 2(c)(2)).
• Starting in 2024, payment decreases cannot exceed 0 percent for 2024, 2.5 percent for 2025, and 5 percent for 2026 and beyond (Sec. 2(d)(1)).
• Starting in 2024, payment increases are capped at 2.5 percent annually for widely available tests through 2025, then 3.75 percent for 2026 and 2027, then 5 percent from 2028 forward (Sec. 2(d)(2)).
• A "widely available clinical diagnostic laboratory test" is defined as a test that costs less than 1,000 dollars per test and is performed by more than 100 applicable laboratories (Sec. 2(a)(1)(C)(iii)).
What Changes
The data collection timeline shifts to begin January 1, 2026, instead of the original January 1, 2024. Labs performing widely available tests will only need to provide data if selected for the government sample, rather than all labs reporting. The "applicable laboratory" definition changes to labs receiving at least 12,500 dollars in Medicare payments during the first 6 months of the calendar year before the data collection period, removing a previous requirement. The government must publish its list of widely available tests by September 30 of the year before each data collection period. Data collection frequency changes from every three years to every four years.
Important Definitions
"Widely available clinical diagnostic laboratory test" means a test costing less than 1,000 dollars per test performed by more than 100 applicable laboratories during the first 6 months of the calendar year immediately before the data collection period (Sec. 2(a)(1)(C)(iii)).
"Applicable laboratory" means a laboratory receiving at least 12,500 dollars in Medicare payments during the first 6 months of the calendar year before the data collection period (Sec. 2(b)).
"Applicable information" includes data on what private insurance companies pay for these tests (Sec. 2(c)).
Effective Date
The bill's data collection provisions take effect beginning January 1, 2026. The government must implement these changes through official rulemaking procedures no later than December 31, 2024 (Sec. 2(e)).
I
118TH CONGRESS
1ST SESSION H. R. 2377
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
MARCH 29, 2023
Mr. HUDSON (for himself, Mr. FITZPATRICK, Mr. PETERS, Mr. PASCRELL,
Mr. BILIRAKIS, Mr. BUCSHON, Ms. KUSTER, and Mr. CRENSHAW) intro-
duced 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-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Saving Access to Lab-
4
oratory Services Act’’.
5
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SEC. 2. MODIFICATION OF REQUIREMENTS FOR MEDICARE
1
CLINICAL DIAGNOSTIC LABORATORY TESTS.
2
(a) USE OF STATISTICAL SAMPLING FOR WIDELY
3
AVAILABLE
CLINICAL
DIAGNOSTIC
LABORATORY
4
TESTS.—
5
(1) IN GENERAL.—Section 1834A(a)(1) of the
6
Social Security Act (42 U.S.C. 1395m–1(a)(1)) is
7
amended—
8
(A) in subparagraph (A), by striking ‘‘Sub-
9
ject to subparagraph (B)’’ and inserting ‘‘Sub-
10
ject to subparagraphs (B) and (C)’’; and
11
(B) by adding at the end the following new
12
subparagraph:
13
‘‘(C) USE OF STATISTICAL SAMPLING FOR
14
WIDELY AVAILABLE CLINICAL DIAGNOSTIC LAB-
15
ORATORY TESTS.—
16
‘‘(i) IN GENERAL.—Subject to clause
17
(ii), with respect to data collection periods
18
for reporting periods beginning on or after
19
January 1, 2026, in the case of a widely
20
available clinical diagnostic laboratory test
21
(as defined in clause (iii)), in lieu of re-
22
quiring the reporting of applicable infor-
23
mation from each applicable laboratory,
24
the Secretary shall require the collection
25
and reporting of applicable information
26
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•HR 2377 IH
from a statistically valid sample of applica-
1
ble laboratories for each such widely avail-
2
able clinical diagnostic laboratory test.
3
‘‘(ii) REQUIREMENTS
FOR
STATIS-
4
TICAL SAMPLING.—
5
‘‘(I) IN
GENERAL.—The Sec-
6
retary, in consultation with stake-
7
holders, shall develop a methodology
8
for a statistically valid sample under
9
clause (i), using the maximal brewer
10
selection method, as described in the
11
June 2021 Medicare Payment Access
12
Commission Report to the Congress,
13
to establish the payment amount for a
14
widely available clinical diagnostic lab-
15
oratory test under paragraph (2) of
16
subsection (b) for each applicable
17
HCPCS code for a widely available
18
clinical diagnostic laboratory test.
19
‘‘(II)
REPRESENTATIVE
SAM-
20
PLING.—The methodology under sub-
21
clause (I) for a statistically valid sam-
22
ple under clause (i) shall, for each ap-
23
plicable HCPCS code for a widely
24
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available clinical diagnostic laboratory
1
test—
2
‘‘(aa) provide for a sample
3
that allows for the payment
4
amounts established under para-
5
graph (2) of subsection (b) for
6
such a test to be representative
7
of rates paid by private payors to
8
applicable laboratories receiving
9
payment under this section, in-
10
cluding independent laboratories,
11
hospital
laboratories,
hospital
12
outreach laboratories, and physi-
13
cian office laboratories that fur-
14
nish the widely available clinical
15
diagnostic laboratory test;
16
‘‘(bb) include applicable in-
17
formation (as defined in para-
18
graph (3)) with respect to such
19
widely available clinical diag-
20
nostic laboratory test from such
21
different types of applicable lab-
22
oratories; and
23
‘‘(cc) be of sufficient size to
24
accurately
and
proportionally
25
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represent the range of private
1
payor payment rates received by
2
each such type of applicable lab-
3
oratory weighted according to the
4
utilization rates of each type of
5
applicable
laboratory
for
the
6
widely available clinical diag-
7
nostic laboratory test during the
8
first 6 months of the calendar
9
year immediately preceding the
10
data collection period applicable
11
to the sample to be collected.
12
‘‘(III) LEAST BURDENSOME DATA
13
COLLECTION
AND
REPORTING
PROC-
14
ESSES.—The methodology developed
15
by the Secretary shall be designed to
16
reduce administrative burdens of data
17
collection and reporting on applicable
18
laboratories and the Centers for Medi-
19
care & Medicaid Services to the great-
20
est extent practicable.
21
‘‘(IV) PUBLICATION OF LIST OF
22
WIDELY
AVAILABLE
CLINICAL
DIAG-
23
NOSTIC LABORATORY TESTS AND NO-
24
TIFICATION TO APPLICABLE LABORA-
25
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TORIES REQUIRED TO REPORT APPLI-
1
CABLE INFORMATION.—Not later than
2
September 30 of the year immediately
3
preceding each data collection period
4
(as defined in paragraph (4)), the
5
Secretary shall publish in the Federal
6
Register a list of widely available clin-
7
ical diagnostic laboratory tests and
8
shall directly notify applicable labora-
9
tories required to report applicable in-
10
formation under this subsection.
11
‘‘(iii) DEFINITION OF WIDELY AVAIL-
12
ABLE CLINICAL DIAGNOSTIC LABORATORY
13
TEST.—In this subparagraph, the term
14
‘widely available clinical diagnostic labora-
15
tory test’ means a clinical diagnostic lab-
16
oratory test that meets both of the fol-
17
lowing criteria during the first 6 months of
18
the calendar year immediately preceding
19
the data collection period applicable to the
20
sample to be collected:
21
‘‘(I) PAYMENT RATE.—The pay-
22
ment amount determined for the clin-
23
ical diagnostic laboratory test under
24
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•HR 2377 IH
this section is less than $1,000 per
1
test.
2
‘‘(II) NUMBER OF LABORATORIES
3
PERFORMING THE TEST.—The num-
4
ber of applicable laboratories receiving
5
payments under this section for the
6
clinical diagnostic laboratory test (as
7
determined by the Secretary using the
8
national provider identifier of the pro-
9
vider of services or supplier on the
10
claim submitted for payment under
11
this part for such test) exceeds 100.’’.
12
(2) DELAYS TO REVISED REPORTING PERIODS
13
AND REPORTING PERIOD FREQUENCY.—
14
(A)
IN
GENERAL.—Section
15
1834A(a)(1)(B) of the Social Security Act (42
16
U.S.C. 1395m–1(a)(1)(B)) is amended—
17
(i) in clause (i), by striking ‘‘Decem-
18
ber 31, 2023’’ and inserting ‘‘December
19
31, 2026’’;
20
(ii) in clause (ii), by striking ‘‘begin-
21
ning January 1, 2024, and ending March
22
31, 2024’’ and inserting ‘‘beginning Janu-
23
ary 1, 2027, and ending March 31, 2027’’;
24
and
25
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•HR 2377 IH
(iii) in clause (iii) by striking ‘‘every
1
three years’’ and inserting ‘‘every four
2
years’’.
3
(B) CONFORMING CHANGE TO DEFINITION
4
OF
DATA
COLLECTION
PERIOD.—Section
5
1834A(a)(4)(B) of the Social Security Act (42
6
U.S.C. 1395m–1(a)(4)(B)) is amended by strik-
7
ing ‘‘January 1, 2019, and ending June 30,
8
2019’’ and inserting ‘‘January 1, 2026, and
9
ending June 30, 2026’’.
10
(b) ELIMINATION OF MAJORITY OF MEDICARE REVE-
11
NUES TEST.—The first sentence of section 1834A(a)(2)
12
of the Social Security Act (42 U.S.C. 1395m–1(a)(2)) is
13
amended by striking ‘‘In this section’’ and all that follows
14
through the period and inserting the following: ‘‘Notwith-
15
standing determinations of applicable laboratories made
16
prior to January 1, 2025, the term ‘applicable laboratory’
17
means a laboratory that receives at least $12,500 in pay-
18
ments under this section during the first 6 months of the
19
calendar year immediately preceding the applicable data
20
collection period.’’.
21
(c) MODIFICATIONS TO APPLICABLE INFORMATION
22
REPORTED.—
23
(1) MEDICAID MANAGED CARE RATES.—Section
24
1834A(a)(8)(C) of the Social Security Act (42
25
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•HR 2377 IH
U.S.C. 1395m–1(a)(8)(C)) is amended by striking
1
‘‘A medicaid managed care organization’’ and insert-
2
ing ‘‘With respect to data collection periods for re-
3
porting periods beginning before January 1, 2027, a
4
medicaid managed care organization (as defined in
5
section 1903(m))’’.
6
(2) AUTHORITY TO EXCLUDE MANUAL REMIT-
7
TANCES.—Section 1834A(a)(3) of the Social Secu-
8
rity Act (42 U.S.C. 1395m–1(a)(3)) is amended—
9
(A) in subparagraph (A), by striking ‘‘sub-
10
ject to subparagraph (B),’’ and inserting ‘‘sub-
11
ject to subparagraphs (B) and (C)’’; and
12
(B) by adding at the end the following new
13
subparagraph:
14
‘‘(C) EXCLUSION
OF
MANUAL
REMIT-
15
TANCES.—An applicable laboratory for which
16
less than 10 percent of its total paid claims
17
during a data collection period are paid by pri-
18
vate payors by means other than an electronic
19
standard transaction (as defined in section
20
162.103 of title 45, Code of Federal Regula-
21
tions (or any successor regulation)) may exclude
22
from the definition of applicable information
23
under this paragraph payments made by private
24
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•HR 2377 IH
payors that are not made through an electronic
1
standard transaction.’’.
2
(d) MODIFICATION TO LIMITS ON PAYMENT REDUC-
3
TIONS; IMPOSITION OF ANNUAL CAP ON PAYMENT IN-
4
CREASES.—
5
(1) PAYMENT
REDUCTION
LIMITS.—Section
6
1834A(b)(3) of the Social Security Act (42 U.S.C.
7
1395m–1(b)(3)) is amended—
8
(A) in subparagraph (A), by striking ‘‘for
9
each of 2017 through 2026’’ and inserting ‘‘for
10
2017 and each succeeding year’’; and
11
(B) in subparagraph (B)—
12
(i) in clause (ii), by striking ‘‘and’’ at
13
the end; and
14
(ii) by striking clause (iii) and insert-
15
ing the following:
16
‘‘(iii) for 2024, 0 percent;
17
‘‘(iv) for 2025, 2.5 percent; and
18
‘‘(v) for 2026 and each subsequent
19
year, 5 percent.’’.
20
(2) ANNUAL
CAP
ON
PAYMENT
RATE
IN-
21
CREASES.—Section 1834A(b)(3) of the Social Secu-
22
rity Act (42 U.S.C. 1395m–1(b)(3)), as amended by
23
paragraph (1), is amended—
24
(A) in subparagraph (A)—
25
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•HR 2377 IH
(i) by striking ‘‘test for 2017 and
1
each succeeding year—’’ and inserting
2
‘‘test—
3
‘‘(i) for 2017 and each succeeding
4
year’’;
5
(ii) in clause (i), as added by clause
6
(i) of this subparagraph, by striking the
7
period and inserting ‘‘; and’’; and
8
(iii) by adding at the end the fol-
9
lowing new clause:
10
‘‘(ii) for 2024 and each succeeding
11
year, shall not result in an increase in pay-
12
ments for a clinical diagnostic laboratory
13
test for the year of greater than the appli-
14
cable percent (as defined in subparagraph
15
(D)) of the amount of payment for the test
16
for the preceding year.’’;
17
(B) in subparagraph (B), in the matter
18
preceding clause (i), by striking ‘‘In this para-
19
graph’’ and inserting ‘‘In clause (i) of subpara-
20
graph (A)’’; and
21
(C) by adding at the end the following new
22
subparagraph:
23
‘‘(D) DEFINITION
OF
APPLICABLE
PER-
24
CENT FOR PURPOSES OF ANNUAL CAP ON PAY-
25
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•HR 2377 IH
MENT INCREASES.—In clause (ii) of subpara-
1
graph (A), the term ‘applicable percent’ means
2
the following:
3
‘‘(i) WIDELY AVAILABLE CLINICAL DI-
4
AGNOSTIC LABORATORY TESTS.—With re-
5
spect to a widely available clinical diag-
6
nostic laboratory test—
7
‘‘(I) for 2024, 2.5 percent;
8
‘‘(II) for 2025, 2.5 percent;
9
‘‘(III) for 2026, 3.75 percent,
10
‘‘(IV) for 2027, 3.75 percent;
11
and
12
‘‘(V) for 2028 and each subse-
13
quent year, 5 percent.
14
‘‘(ii) OTHER
CLINICAL
DIAGNOSTIC
15
LABORATORY
TESTS.—With respect to a
16
clinical diagnostic laboratory test not de-
17
scribed in clause (i), 5 percent.’’.
18
(3)
CONFORMING
AMENDMENT.—Section
19
1834A(b)(3) of the Social Security Act (42 U.S.C.
20
1395m–1(b)(3)) is amended in the heading by strik-
21
ing ‘‘REDUCTIONS’’ and inserting ‘‘MEDICARE PAY-
22
MENT CHANGES’’.
23
(e) REGULATIONS.—(1) Not later than December 31,
24
2024, the Secretary of Health and Human Services shall
25
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•HR 2377 IH
implement the amendments made by this section (other
1
than subsection (d)) through notice and comment rule-
2
making.
3
(2) The Secretary of Health and Human Services
4
may implement the amendments made by subsection (d)
5
through interim final rulemaking, program instruction, or
6
otherwise.
7
Æ
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