I
119THCONGRESS
1
STSESSION H. R. 842
To amend title XVIII of the Social Security Act to provide for Medicare
coverage of multi-cancer early detection screening tests.
IN THE HOUSE OF REPRESENTATIVES
JANUARY31, 2025
Mr. A
RRINGTON(for himself, Ms. SEWELL, Mr. HUDSON, Mr. RUIZ, Mrs.
M
ILLER-MEEKS, and Ms. KELLYof Illinois) 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 subse-
quently 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 provide
for Medicare coverage of multi-cancer early detection
screening tests.
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 ‘‘Nancy Gardner Sewell 4
Medicare Multi-Cancer Early Detection Screening Cov-5
erage Act’’. 6
VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
ssavage on LAPJG3WLY3PROD with BILLS 2
•HR 842 IH
SEC. 2. MEDICARE COVERAGE OF MULTI-CANCER EARLY 1
DETECTION SCREENING TESTS. 2
(a) C
OVERAGE.—Section 1861 of the Social Security 3
Act (42 U.S.C. 1395x) is amended— 4
(1) in subsection (s)(2)— 5
(A) by striking the semicolon at the end of 6
subparagraph (JJ) and inserting ‘‘; and’’; and 7
(B) by adding at the end the following new 8
subparagraph: 9
‘‘(KK) multi-cancer early detection screen-10
ing tests (as defined in subsection (nnn));’’; and 11
(2) by adding at the end the following new sub-12
section: 13
‘‘(nnn) M
ULTI-CANCEREARLYDETECTIONSCREEN-14
INGTESTS.— 15
‘‘(1) I
N GENERAL.—The term ‘multi-cancer 16
early detection screening test’ means a test fur-17
nished to an individual for the concurrent detection 18
of multiple cancer types across multiple organ sites 19
on or after January 1, 2028, that— 20
‘‘(A) is cleared under section 510(k), clas-21
sified under section 513(f)(2), or approved 22
under section 515 of the Federal Food, Drug, 23
and Cosmetic Act; 24
‘‘(B) is— 25
VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
ssavage on LAPJG3WLY3PROD with BILLS 3
•HR 842 IH
‘‘(i) a genomic sequencing blood or 1
blood product test that includes the anal-2
ysis of cell-free nucleic acids; or 3
‘‘(ii) a test based on samples of bio-4
logical material that provides results com-5
parable to those obtained with a test de-6
scribed in clause (i), as determined by the 7
Secretary; and 8
‘‘(C) the Secretary determines is— 9
‘‘(i) reasonable and necessary for the 10
prevention or early detection of an illness 11
or disability; and 12
‘‘(ii) appropriate for individuals enti-13
tled to benefits under part A or enrolled 14
under part B. 15
‘‘(2) NCD
PROCESS.—In making determina-16
tions under paragraph (1)(C) regarding the coverage 17
of a new test, the Secretary shall use the process for 18
making national coverage determinations (as defined 19
in section 1869(f)(1)(B)) under this title.’’. 20
(b) P
AYMENT ANDSTANDARDS FOR MULTI-CANCER 21
E
ARLYDETECTIONSCREENINGTESTS.— 22
(1) I
N GENERAL.—Section 1834 of the Social 23
Security Act (42 U.S.C. 1395m) is amended by add-24
ing at the end the following new subsection: 25
VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
ssavage on LAPJG3WLY3PROD with BILLS 4
•HR 842 IH
‘‘(aa) PAYMENT AND STANDARDS FOR MULTI-CAN-1
CEREARLYDETECTIONSCREENINGTESTS.— 2
‘‘(1) P
AYMENT AMOUNT .—The payment 3
amount for a multi-cancer early detection screening 4
test (as defined in section 1861(nnn)) is— 5
‘‘(A) with respect to such a test furnished 6
before January 1, 2031, equal to the payment 7
amount in effect on the date of the enactment 8
of this subsection for a multi-target stool 9
screening DNA test covered pursuant to section 10
1861(pp)(1)(D); and 11
‘‘(B) with respect to such a test furnished 12
on or after January 1, 2031, equal to the lesser 13
of— 14
‘‘(i) the amount described in subpara-15
graph (A); or 16
‘‘(ii) the payment amount determined 17
for such test under section 1834A. 18
‘‘(2) L
IMITATIONS.— 19
‘‘(A) I
N GENERAL.—No payment may be 20
made under this part for a multi-cancer early 21
detection screening test furnished during a year 22
to an individual if— 23
VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
ssavage on LAPJG3WLY3PROD with BILLS 5
•HR 842 IH
‘‘(i) as of January 1 of such year, 1
such individual has attained the age speci-2
fied in subparagraph (B) for such year; or 3
‘‘(ii) such a test was furnished to the 4
individual during the previous 11 months. 5
‘‘(B) A
GE SPECIFIED.—For purposes of 6
subparagraph (A)(i), the age specified in this 7
subparagraph is— 8
‘‘(i) for 2028, 68 years of age; and 9
‘‘(ii) for a succeeding year, the age 10
specified in this subparagraph for the pre-11
ceding year, increased by 1 year. 12
‘‘(3) S
TANDARDS FOLLOWING USPSTF RAT -13
ING.—In the case of a multi-cancer early detection 14
screening test that is recommended with a grade of 15
A or B by the United States Preventive Services 16
Task Force, beginning on the date on which cov-17
erage for such test is provided pursuant to section 18
1861(ddd)(1), the preceding provisions of this sub-19
section shall not apply.’’. 20
(2) C
ONFORMING AMENDMENTS .— 21
(A) Section 1833 of the Social Security 22
Act (42 U.S.C. 1395l) is amended— 23
(i) in subsection (a)— 24
VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
ssavage on LAPJG3WLY3PROD with BILLS 6
•HR 842 IH
(I) in paragraph (1)(D)(i)(I), by 1
striking ‘‘section 1834(d)(1)’’ and in-2
serting ‘‘subsection (d)(1) or (aa) of 3
section 1834’’; and 4
(II) in paragraph (2)(D)(i)(I), by 5
striking ‘‘section 1834(d)(1)’’ and in-6
serting ‘‘subsection (d)(1) or (aa) of 7
section 1834’’; and 8
(ii) in subsection (h), by striking ‘‘sec-9
tion 1834(d)(1)’’ and inserting ‘‘sub-10
sections (d)(1) and (aa) of section 1834’’. 11
(B) Section 1862(a) of the Social Security 12
Act (42 U.S.C. 1395y(a)) is amended— 13
(i) in paragraph (1)— 14
(I) in subparagraph (O), by 15
striking ‘‘and’’ at the end; 16
(II) in subparagraph (P), by 17
striking the semicolon at the end and 18
inserting ‘‘, and’’; and 19
(III) by adding at the end the 20
following new subparagraph: 21
‘‘(Q) in the case of multi-cancer early de-22
tection screening tests (as defined in section 23
1861(nnn)), which are not reasonable and nec-24
VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
ssavage on LAPJG3WLY3PROD with BILLS 7
•HR 842 IH
essary for the concurrent detection of multiple 1
cancer types across multiple organ sites;’’; and 2
(ii) in paragraph (7), by striking ‘‘or 3
(P)’’ and inserting ‘‘(P), or (Q)’’. 4
(c) R
ULE OFCONSTRUCTIONRELATING TOOTHER 5
C
ANCERSCREENINGTESTS.—Nothing in this section, in-6
cluding the amendments made by this section, shall be 7
construed— 8
(1) in the case of an individual who undergoes 9
a multi-cancer early detection screening test, to af-10
fect coverage under part B of title XVIII of the So-11
cial Security Act for other cancer screening tests 12
covered under such title, such as screening tests for 13
breast, cervical, colorectal, lung, or prostate cancer; 14
or 15
(2) in the case of an individual who undergoes 16
another cancer screening test, to affect coverage 17
under such part for a multi-cancer early detection 18
screening test or the use of such a test as a diag-19
nostic or confirmatory test for a result of the other 20
cancer screening test. 21
Æ
VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H842.IH H842
ssavage on LAPJG3WLY3PROD with BILLS