Reducing Hereditary Cancer Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 4110 To amend title XVIII of the Social Security Act to provide hereditary cancer genetic testing for individuals with a history of a hereditary cancer gene mutation in a blood relative or a personal or ancestral history suspicious for hereditary cancer, and to provide coverage of certain cancer screenings or preventive surgeries that would reduce the risk for individuals with a germline (inherited) mutation associated with a high risk of developing a preventable cancer. IN THE HOUSE OF REPRESENTATIVES JUNE 23, 2021 Ms. WASSERMAN SCHULTZ (for herself, Mrs. MILLER-MEEKS, Ms. SLOTKIN, and Mr. RODNEY DAVIS of 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 subsequently determined by the Speaker, in each case for consideration of such provi- sions as fall within the jurisdiction of the committee concerned A BILL To amend title XVIII of the Social Security Act to provide hereditary cancer genetic testing for individuals with a history of a hereditary cancer gene mutation in a blood relative or a personal or ancestral history suspicious for hereditary cancer, and to provide coverage of certain cancer screenings or preventive surgeries that would re- duce the risk for individuals with a germline (inherited) mutation associated with a high risk of developing a preventable cancer. VerDate Sep 11 2014 04:31 Jul 22, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H4110.IH H4110 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 4110 IH 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 ‘‘Reducing Hereditary 4 Cancer Act of 2021’’. 5 SEC. 2. HEREDITARY CANCER GENETIC TESTING OF INDI- 6 VIDUALS WITH A FAMILY HISTORY OF A HE- 7 REDITARY CANCER GENE MUTATION OR PER- 8 SONAL OR FAMILY HISTORY SUSPICIOUS FOR 9 HEREDITARY CANCER. 10 (a) COVERAGE.—Section 1861 of the Social Security 11 Act (42 U.S.C. 1395x) is amended— 12 (1) in subsection (s)(2)— 13 (A) by striking ‘‘and’’ at the end of sub- 14 paragraph (GG); 15 (B) by striking the period and inserting ‘‘; 16 and’’ at the end of subparagraph (HH); and 17 (C) by inserting after subparagraph (HH) 18 the following new subparagraph: 19 ‘‘(II) in the case of an individual with a 20 personal or family history of a hereditary can- 21 cer gene mutation or a personal or family his- 22 tory suspicious for hereditary cancer, germline 23 mutation testing.’’; and 24 VerDate Sep 11 2014 04:31 Jul 22, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4110.IH H4110 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 4110 IH (2) by adding at the end the following new sub- 1 section: 2 ‘‘(lll) GERMLINE MUTATION TESTING.—The term 3 ‘germline mutation testing’ means genetic testing for 4 germline mutations that is in accordance with evidence- 5 based, clinical practice guidelines specifically addressing 6 genetic testing, screening, and management of individuals 7 with inherited mutations associated with increased cancer 8 risk that— 9 ‘‘(1) have been developed by a nationally recog- 10 nized oncology professional organization, including 11 the National Comprehensive Cancer Network, the 12 American Society of Clinical Oncology, the Society 13 of Gynecologic Oncology, or any other oncology pro- 14 fessional organization specified by a medicare ad- 15 ministrative contractor with a contract under section 16 1874A; and 17 ‘‘(2) in the case of conflicting guidelines devel- 18 oped by more than one nationally recognized oncol- 19 ogy professional organization, the least restrictive of 20 such guidelines, as determined by such a medicare 21 administrative contractor.’’. 22 (b) FREQUENCY.—Section 1862(a)(1) of the Social 23 Security Act (42 U.S.C. 1395y(a)(1)) is amended— 24 VerDate Sep 11 2014 04:31 Jul 22, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4110.IH H4110 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 4110 IH (1) by striking ‘‘and’’ at the end of subpara- 1 graph (O); 2 (2) by adding ‘‘and’’ at the end of subpara- 3 graph (P); and 4 (3) by adding at the end the following new sub- 5 paragraph: 6 ‘‘(Q) in the case of germline mutation test- 7 ing as defined in section 1861(lll), which is per- 8 formed more than once with respect to an indi- 9 vidual described in such section;’’. 10 (c) EFFECTIVE DATE.—The amendments made by 11 this section shall apply to testing furnished on or after 12 the date of the enactment of this Act. 13 SEC. 3. COVERAGE OF CERTAIN PREVENTIVE SURGERIES. 14 (a) IN GENERAL.—Section 1862 of the Social Secu- 15 rity Act (42 U.S.C. 1395y) is amended by adding at the 16 end the following new subsection: 17 ‘‘(p) COVERAGE OF CERTAIN RISK-REDUCING SUR- 18 GERIES.—In the case of an individual described in section 19 1861(s)(2)(II) for whom, based on evidence-based, clinical 20 practice guidelines described in section 1861(lll), surgery 21 would reduce the risk of developing cancer, such risk-re- 22 ducing surgery shall be considered reasonable and nec- 23 essary for treatment of illness under subsection 24 (a)(1)(A).’’. 25 VerDate Sep 11 2014 04:31 Jul 22, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4110.IH H4110 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 4110 IH (b) EFFECTIVE DATE.—The amendment made by 1 subsection (a) shall apply to items and services furnished 2 on or after the date of the enactment of this Act. 3 SEC. 4. COVERAGE OF EVIDENCE-BASED SCREENINGS FOR 4 INDIVIDUALS WITH A HEREDITARY CANCER 5 GENE MUTATION. 6 (a) IN GENERAL.—Section 1862 of the Social Secu- 7 rity Act (42 U.S.C. 1395y), as amended by section 3, is 8 amended by adding at the end the following new sub- 9 section: 10 ‘‘(q) COVERAGE OF EVIDENCE-BASED SCREENINGS 11 FOR INDIVIDUALS WITH A HEREDITARY CANCER GENE 12 MUTATION.—In the case of an individual who is deter- 13 mined pursuant to genetic testing to have a hereditary 14 cancer (germline) gene mutation, the Secretary shall in- 15 crease any frequency limitations (or other limitations on 16 coverage otherwise applicable under this title) for any evi- 17 dence-based screenings furnished to such individual, to be 18 in compliance with evidence-based, clinical practice guide- 19 lines described in section 1861(lll), or as determined ap- 20 propriate by the Secretary, but not less frequently than 21 on an annual basis. For the purposes of this subsection, 22 evidence-based screenings shall include screening mam- 23 mography, breast screening MRI, colonoscopy, PSA test- 24 ing, and any additional evidence-based screening modali- 25 VerDate Sep 11 2014 04:31 Jul 22, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4110.IH H4110 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 4110 IH ties appropriate for high-risk individuals as recommended 1 by such guidelines.’’. 2 (b) CONFORMING AMENDMENT FOR SCREENING 3 MAMMOGRAPHY.—Section 1834(c)(2)(A) of the Social Se- 4 curity Act (42 U.S.C. 1395m(c)(2)(A)) is amended, in the 5 matter preceding clause (i), by striking ‘‘subparagraph 6 (B)’’ and inserting ‘‘subparagraph (B) and section 7 1862(q)’’. 8 (c) EFFECTIVE DATE.—The amendments made by 9 this section shall apply to items and services furnished on 10 or after the date of the enactment of this Act. 11 Æ VerDate Sep 11 2014 04:31 Jul 22, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H4110.IH H4110 pbinns on DSKJLVW7X2PROD with BILLS