What This Bill Does
This bill amends Medicare's rules for paying clinical diagnostic laboratory services (blood tests and similar lab work). It allows Medicare to collect payment information from a sample of labs instead of requiring all labs to report. The bill also changes how Medicare sets payment amounts and reduces how often labs must report data.
Who It Affects
Clinical diagnostic laboratories that receive Medicare payments, including independent laboratories, hospital laboratories, hospital outreach laboratories and physician office laboratories. The Centers for Medicare and Medicaid Services (the federal agency that runs Medicare). Private insurance companies that pay for lab tests. Medicaid managed care organizations.
Key Provisions
- Starting January 1, 2026, Medicare can collect payment information from a statistically valid sample of laboratories instead of all laboratories for widely available clinical diagnostic laboratory tests (Sec. 2(a)(1)).
- The sample methodology must be representative of payment rates from private insurance companies and include different types of laboratories weighted by how often each type performs the test (Sec. 2(a)(1)).
- A laboratory qualifies as "applicable" if it receives at least $12,500 in Medicare payments during the first six months of the calendar year before the data collection period, replacing a previous majority revenue test (Sec. 2(b)).
- A "widely available clinical diagnostic laboratory test" means a test that costs less than $1,000 per test and is performed by more than 100 laboratories during the first six months of the year before the data collection period (Sec. 2(a)(1)).
- Starting in 2024, payment increases for widely available tests are capped at 2.5 percent per year in 2024 and 2025, then 3.75 percent in 2026 and 2027, then 5 percent in 2028 and beyond; other tests have a 5 percent annual cap (Sec. 2(d)).
- Data collection periods move from reporting periods beginning January 1, 2027, through March 31, 2027, and reporting occurs every four years instead of every three years (Sec. 2(a)(2)).
- Laboratories where fewer than 10 percent of paid claims come through electronic standard transactions can exclude manual payments from the payment information they report (Sec. 2(c)(2)).
What Changes
If this bill becomes law, most laboratories will no longer need to report all their private insurance payment data to Medicare. Instead, Medicare will collect detailed information from a smaller sample of selected laboratories. Labs will also report data less frequently (every four years instead of every three years) and starting later (2026 instead of 2024). The definition of which labs must participate changes to require at least $12,500 in Medicare payments rather than majority revenue from Medicare. Payment increases will face yearly limits that are lower for widely available tests than for other tests.
Important Definitions
- "Widely available clinical diagnostic laboratory test": a test that costs less than $1,000 per test and is performed by more than 100 laboratories.
- "Applicable laboratory": a laboratory receiving at least $12,500 in Medicare payments during the first six months of the calendar year immediately before the data collection period.
- "Applicable information": payment data from private insurance companies that laboratories must report to Medicare (Sec. 2(c)).
- "Electronic standard transaction": Not specified in bill text (the bill references a federal regulation definition).
Effective Date
The use of statistical sampling begins with data collection periods for reporting periods starting on or after January 1, 2026 (Sec. 2(a)(1)). The new laboratory definition takes effect January 1, 2025 (Sec. 2(b)). The Secretary of Health and Human Services must implement most amendments through rulemaking by December 31, 2024 (Sec. 2(e)).
II
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 serv-
ices, 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 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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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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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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(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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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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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)—
13
(I) by striking ‘‘through 2023’’
14
and inserting ‘‘through 2024’’; and
15
(II) by striking ‘‘and’’ at the end;
16
and
17
(ii) by striking clause (iii) and insert-
18
ing the following:
19
‘‘(iii) for 2025, 2.5 percent; and
20
‘‘(iv) for 2026 and each subsequent
21
year, 5 percent.’’.
22
(2) ANNUAL
CAP
ON
PAYMENT
RATE
IN-
23
CREASES.—Section 1834A(b)(3) of the Social Secu-
24
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rity Act (42 U.S.C. 1395m–1(b)(3)), as amended by
1
paragraph (1), is amended—
2
(A) in subparagraph (A)—
3
(i) by striking ‘‘test for 2017 and
4
each succeeding year—’’ and inserting
5
‘‘test—
6
‘‘(i) for 2017 and each succeeding
7
year’’;
8
(ii) in clause (i), as added by clause
9
(i) of this subparagraph, by striking the
10
period and inserting ‘‘; and’’; and
11
(iii) by adding at the end the fol-
12
lowing new clause:
13
‘‘(ii) for 2024 and each succeeding
14
year, shall not result in an increase in pay-
15
ments for a clinical diagnostic laboratory
16
test for the year of greater than the appli-
17
cable percent (as defined in subparagraph
18
(D)) of the amount of payment for the test
19
for the preceding year.’’;
20
(B) in subparagraph (B), in the matter
21
preceding clause (i), by striking ‘‘In this para-
22
graph’’ and inserting ‘‘In clause (i) of subpara-
23
graph (A)’’; and
24
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(C) by adding at the end the following new
1
subparagraph:
2
‘‘(D) DEFINITION
OF
APPLICABLE
PER-
3
CENT FOR PURPOSES OF ANNUAL CAP ON PAY-
4
MENT INCREASES.—In clause (ii) of subpara-
5
graph (A), the term ‘applicable percent’ means
6
the following:
7
‘‘(i) WIDELY AVAILABLE CLINICAL DI-
8
AGNOSTIC LABORATORY TESTS.—With re-
9
spect to a widely available clinical diag-
10
nostic laboratory test—
11
‘‘(I) for each of 2024 and 2025,
12
2.5 percent;
13
‘‘(II) for each of 2026 and 2027,
14
3.75 percent; and
15
‘‘(III) for 2028 and each subse-
16
quent year, 5 percent.
17
‘‘(ii) OTHER
CLINICAL
DIAGNOSTIC
18
LABORATORY
TESTS.—With respect to a
19
clinical diagnostic laboratory test not de-
20
scribed in clause (i), 5 percent.’’.
21
(3)
CONFORMING
AMENDMENT.—Section
22
1834A(b)(3) of the Social Security Act (42 U.S.C.
23
1395m–1(b)(3)) is amended in the heading by strik-
24
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ing ‘‘REDUCTIONS’’ and inserting ‘‘MEDICARE PAY-
1
MENT CHANGES’’.
2
(e) REGULATIONS.—(1) Not later than December 31,
3
2024, the Secretary of Health and Human Services shall
4
implement the amendments made by this section (other
5
than subsection (d)) through notice and comment rule-
6
making.
7
(2) The Secretary of Health and Human Services
8
may implement the amendments made by subsection (d)
9
through interim final rulemaking, program instruction, or
10
otherwise.
11
Æ
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