Us Congress 2025-2026 Regular Session

Us Congress House Bill HB842 Compare Versions

Only one version of the bill is available at this time.
OldNewDifferences
11 I
22 119THCONGRESS
33 1
44 STSESSION H. R. 842
55 To amend title XVIII of the Social Security Act to provide for Medicare
66 coverage of multi-cancer early detection screening tests.
77 IN THE HOUSE OF REPRESENTATIVES
88 JANUARY31, 2025
99 Mr. A
1010 RRINGTON(for himself, Ms. SEWELL, Mr. HUDSON, Mr. RUIZ, Mrs.
1111 M
1212 ILLER-MEEKS, and Ms. KELLYof Illinois) introduced the following bill;
1313 which was referred to the Committee on Energy and Commerce, and in
1414 addition to the Committee on Ways and Means, for a period to be subse-
1515 quently determined by the Speaker, in each case for consideration of such
1616 provisions as fall within the jurisdiction of the committee concerned
1717 A BILL
1818 To amend title XVIII of the Social Security Act to provide
1919 for Medicare coverage of multi-cancer early detection
2020 screening tests.
2121 Be it enacted by the Senate and House of Representa-1
2222 tives of the United States of America in Congress assembled, 2
2323 SECTION 1. SHORT TITLE. 3
2424 This Act may be cited as the ‘‘Nancy Gardner Sewell 4
2525 Medicare Multi-Cancer Early Detection Screening Cov-5
2626 erage Act’’. 6
2727 VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
2828 ssavage on LAPJG3WLY3PROD with BILLS 2
2929 •HR 842 IH
3030 SEC. 2. MEDICARE COVERAGE OF MULTI-CANCER EARLY 1
3131 DETECTION SCREENING TESTS. 2
3232 (a) C
3333 OVERAGE.—Section 1861 of the Social Security 3
3434 Act (42 U.S.C. 1395x) is amended— 4
3535 (1) in subsection (s)(2)— 5
3636 (A) by striking the semicolon at the end of 6
3737 subparagraph (JJ) and inserting ‘‘; and’’; and 7
3838 (B) by adding at the end the following new 8
3939 subparagraph: 9
4040 ‘‘(KK) multi-cancer early detection screen-10
4141 ing tests (as defined in subsection (nnn));’’; and 11
4242 (2) by adding at the end the following new sub-12
4343 section: 13
4444 ‘‘(nnn) M
4545 ULTI-CANCEREARLYDETECTIONSCREEN-14
4646 INGTESTS.— 15
4747 ‘‘(1) I
4848 N GENERAL.—The term ‘multi-cancer 16
4949 early detection screening test’ means a test fur-17
5050 nished to an individual for the concurrent detection 18
5151 of multiple cancer types across multiple organ sites 19
5252 on or after January 1, 2028, that— 20
5353 ‘‘(A) is cleared under section 510(k), clas-21
5454 sified under section 513(f)(2), or approved 22
5555 under section 515 of the Federal Food, Drug, 23
5656 and Cosmetic Act; 24
5757 ‘‘(B) is— 25
5858 VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
5959 ssavage on LAPJG3WLY3PROD with BILLS 3
6060 •HR 842 IH
6161 ‘‘(i) a genomic sequencing blood or 1
6262 blood product test that includes the anal-2
6363 ysis of cell-free nucleic acids; or 3
6464 ‘‘(ii) a test based on samples of bio-4
6565 logical material that provides results com-5
6666 parable to those obtained with a test de-6
6767 scribed in clause (i), as determined by the 7
6868 Secretary; and 8
6969 ‘‘(C) the Secretary determines is— 9
7070 ‘‘(i) reasonable and necessary for the 10
7171 prevention or early detection of an illness 11
7272 or disability; and 12
7373 ‘‘(ii) appropriate for individuals enti-13
7474 tled to benefits under part A or enrolled 14
7575 under part B. 15
7676 ‘‘(2) NCD
7777 PROCESS.—In making determina-16
7878 tions under paragraph (1)(C) regarding the coverage 17
7979 of a new test, the Secretary shall use the process for 18
8080 making national coverage determinations (as defined 19
8181 in section 1869(f)(1)(B)) under this title.’’. 20
8282 (b) P
8383 AYMENT ANDSTANDARDS FOR MULTI-CANCER 21
8484 E
8585 ARLYDETECTIONSCREENINGTESTS.— 22
8686 (1) I
8787 N GENERAL.—Section 1834 of the Social 23
8888 Security Act (42 U.S.C. 1395m) is amended by add-24
8989 ing at the end the following new subsection: 25
9090 VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
9191 ssavage on LAPJG3WLY3PROD with BILLS 4
9292 •HR 842 IH
9393 ‘‘(aa) PAYMENT AND STANDARDS FOR MULTI-CAN-1
9494 CEREARLYDETECTIONSCREENINGTESTS.— 2
9595 ‘‘(1) P
9696 AYMENT AMOUNT .—The payment 3
9797 amount for a multi-cancer early detection screening 4
9898 test (as defined in section 1861(nnn)) is— 5
9999 ‘‘(A) with respect to such a test furnished 6
100100 before January 1, 2031, equal to the payment 7
101101 amount in effect on the date of the enactment 8
102102 of this subsection for a multi-target stool 9
103103 screening DNA test covered pursuant to section 10
104104 1861(pp)(1)(D); and 11
105105 ‘‘(B) with respect to such a test furnished 12
106106 on or after January 1, 2031, equal to the lesser 13
107107 of— 14
108108 ‘‘(i) the amount described in subpara-15
109109 graph (A); or 16
110110 ‘‘(ii) the payment amount determined 17
111111 for such test under section 1834A. 18
112112 ‘‘(2) L
113113 IMITATIONS.— 19
114114 ‘‘(A) I
115115 N GENERAL.—No payment may be 20
116116 made under this part for a multi-cancer early 21
117117 detection screening test furnished during a year 22
118118 to an individual if— 23
119119 VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
120120 ssavage on LAPJG3WLY3PROD with BILLS 5
121121 •HR 842 IH
122122 ‘‘(i) as of January 1 of such year, 1
123123 such individual has attained the age speci-2
124124 fied in subparagraph (B) for such year; or 3
125125 ‘‘(ii) such a test was furnished to the 4
126126 individual during the previous 11 months. 5
127127 ‘‘(B) A
128128 GE SPECIFIED.—For purposes of 6
129129 subparagraph (A)(i), the age specified in this 7
130130 subparagraph is— 8
131131 ‘‘(i) for 2028, 68 years of age; and 9
132132 ‘‘(ii) for a succeeding year, the age 10
133133 specified in this subparagraph for the pre-11
134134 ceding year, increased by 1 year. 12
135135 ‘‘(3) S
136136 TANDARDS FOLLOWING USPSTF RAT -13
137137 ING.—In the case of a multi-cancer early detection 14
138138 screening test that is recommended with a grade of 15
139139 A or B by the United States Preventive Services 16
140140 Task Force, beginning on the date on which cov-17
141141 erage for such test is provided pursuant to section 18
142142 1861(ddd)(1), the preceding provisions of this sub-19
143143 section shall not apply.’’. 20
144144 (2) C
145145 ONFORMING AMENDMENTS .— 21
146146 (A) Section 1833 of the Social Security 22
147147 Act (42 U.S.C. 1395l) is amended— 23
148148 (i) in subsection (a)— 24
149149 VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
150150 ssavage on LAPJG3WLY3PROD with BILLS 6
151151 •HR 842 IH
152152 (I) in paragraph (1)(D)(i)(I), by 1
153153 striking ‘‘section 1834(d)(1)’’ and in-2
154154 serting ‘‘subsection (d)(1) or (aa) of 3
155155 section 1834’’; and 4
156156 (II) in paragraph (2)(D)(i)(I), by 5
157157 striking ‘‘section 1834(d)(1)’’ and in-6
158158 serting ‘‘subsection (d)(1) or (aa) of 7
159159 section 1834’’; and 8
160160 (ii) in subsection (h), by striking ‘‘sec-9
161161 tion 1834(d)(1)’’ and inserting ‘‘sub-10
162162 sections (d)(1) and (aa) of section 1834’’. 11
163163 (B) Section 1862(a) of the Social Security 12
164164 Act (42 U.S.C. 1395y(a)) is amended— 13
165165 (i) in paragraph (1)— 14
166166 (I) in subparagraph (O), by 15
167167 striking ‘‘and’’ at the end; 16
168168 (II) in subparagraph (P), by 17
169169 striking the semicolon at the end and 18
170170 inserting ‘‘, and’’; and 19
171171 (III) by adding at the end the 20
172172 following new subparagraph: 21
173173 ‘‘(Q) in the case of multi-cancer early de-22
174174 tection screening tests (as defined in section 23
175175 1861(nnn)), which are not reasonable and nec-24
176176 VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H842.IH H842
177177 ssavage on LAPJG3WLY3PROD with BILLS 7
178178 •HR 842 IH
179179 essary for the concurrent detection of multiple 1
180180 cancer types across multiple organ sites;’’; and 2
181181 (ii) in paragraph (7), by striking ‘‘or 3
182182 (P)’’ and inserting ‘‘(P), or (Q)’’. 4
183183 (c) R
184184 ULE OFCONSTRUCTIONRELATING TOOTHER 5
185185 C
186186 ANCERSCREENINGTESTS.—Nothing in this section, in-6
187187 cluding the amendments made by this section, shall be 7
188188 construed— 8
189189 (1) in the case of an individual who undergoes 9
190190 a multi-cancer early detection screening test, to af-10
191191 fect coverage under part B of title XVIII of the So-11
192192 cial Security Act for other cancer screening tests 12
193193 covered under such title, such as screening tests for 13
194194 breast, cervical, colorectal, lung, or prostate cancer; 14
195195 or 15
196196 (2) in the case of an individual who undergoes 16
197197 another cancer screening test, to affect coverage 17
198198 under such part for a multi-cancer early detection 18
199199 screening test or the use of such a test as a diag-19
200200 nostic or confirmatory test for a result of the other 20
201201 cancer screening test. 21
202202 Æ
203203 VerDate Sep 11 2014 00:51 Feb 27, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H842.IH H842
204204 ssavage on LAPJG3WLY3PROD with BILLS