II 117th CONGRESS 2d Session S. 3656 IN THE SENATE OF THE UNITED STATES February 16, 2022 Ms. Murkowski (for herself and Mr. Cardin ) 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 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.

1. Short title This Act may be cited as the Reducing Hereditary Cancer Act of 2022 . 2. Hereditary cancer genetic testing of individuals with a family history of a hereditary cancer gene mutation or personal or family history suspicious for hereditary cancer (a) Coverage Section 1861 of the Social Security Act ( 42 U.S.C. 1395x ) is amended— (1) in subsection (s)(2)— (A) by striking and at the end of subparagraph (GG); (B) by striking the period and inserting ; and at the end of subparagraph (HH); and (C) by inserting after subparagraph (HH) the following new subparagraph: (II) in the case of an individual with a personal or family history of a hereditary cancer gene mutation or a personal or family history suspicious for hereditary cancer, germline mutation testing. ; and (2) by adding at the end the following new subsection: (lll) Germline mutation testing The term germline mutation testing means genetic testing for germline mutations that is in accordance with evidence-based, clinical practice guidelines specifically addressing genetic testing, screening, and management of individuals with inherited mutations associated with increased cancer risk that— (1) have been developed by a nationally recognized oncology professional organization, including the National Comprehensive Cancer Network, the American Society of Clinical Oncology, the Society of Gynecologic Oncology, or any other oncology professional organization specified by a medicare administrative contractor with a contract under section 1874A; and (2) in the case of conflicting guidelines developed by more than one nationally recognized oncology professional organization, the least restrictive of such guidelines, as determined by such a medicare administrative contractor. . (b) Frequency Section 1862(a)(1) of the Social Security Act ( 42 U.S.C. 1395y(a)(1) ) is amended— (1) by striking and at the end of subparagraph (O); (2) by adding and at the end of subparagraph (P); and (3) by adding at the end the following new subparagraph: (Q) in the case of germline mutation testing as defined in section 1861(lll), which is performed more than once with respect to an individual described in such section; . (c) Effective date The amendments made by this section shall apply to testing furnished on or after the date of the enactment of this Act. 3. Coverage of certain preventive surgeries (a) In general Section 1862 of the Social Security Act ( 42 U.S.C. 1395y ) is amended by adding at the end the following new subsection: (p) Coverage of certain risk-Reducing surgeries In the case of an individual described in section 1861(s)(2)(II) for whom, based on evidence-based, clinical practice guidelines described in section 1861(lll), surgery would reduce the risk of developing cancer, such risk-reducing surgery shall be considered reasonable and necessary for treatment of illness under subsection (a)(1)(A). . (b) Effective date The amendment made by subsection (a) shall apply to items and services furnished on or after the date of the enactment of this Act. 4. Coverage of evidence-based screenings for individuals with a hereditary cancer gene mutation (a) In general Section 1862 of the Social Security Act ( 42 U.S.C. 1395y ), as amended by section 3, is amended by adding at the end the following new subsection: (q) Coverage of evidence-Based screenings for individuals with a hereditary cancer gene mutation In the case of an individual who is determined pursuant to genetic testing to have a hereditary cancer (germline) gene mutation, the Secretary shall increase any frequency limitations (or other limitations on coverage otherwise applicable under this title) for any evidence-based screenings furnished to such individual, to be in compliance with evidence-based, clinical practice guidelines described in section 1861(lll), or as determined appropriate by the Secretary, but not less frequently than on an annual basis. For the purposes of this subsection, evidence-based screenings shall include screening mammography, breast screening MRI, colonoscopy, PSA testing, and any additional evidence-based screening modalities appropriate for high-risk individuals as recommended by such guidelines. . (b) Conforming amendment for screening mammography Section 1834(c)(2)(A) of the Social Security Act ( 42 U.S.C. 1395m(c)(2)(A) ) is amended, in the matter preceding clause (i), by striking subparagraph (B) and inserting subparagraph (B) and section 1862(q) . (c) Effective date The amendments made by this section shall apply to items and services furnished on or after the date of the enactment of this Act.