HR4752-119

1. Short title This Act may be cited as the Reducing Hereditary Cancer Act.

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 Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended— in subsection (s)(2)— by striking and at the end of subparagraph (II); by striking the period and inserting ; and at the end of subparagraph (JJ); and by inserting after subparagraph (JJ) the following new subparagraph: 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. by adding at the end the following new subsection: 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— 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 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. Section 1862(a)(1) of the Social Security Act (42 U.S.C. 1395y(a)(1)) is amended— by striking and at the end of subparagraph (O); by adding and at the end of subparagraph (P); and by adding at the end the following new subparagraph: 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; The amendments made by this section shall apply to testing furnished on or after the date of the enactment of this Act. (KK)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 (nnn)Germline mutation testingThe 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.. (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;.

3. Coverage of certain preventive surgeries Section 1862 of the Social Security Act (42 U.S.C. 1395y) is amended by adding at the end the following new subsection: 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). The amendment made by subsection (a) shall apply to items and services furnished on or after the date of the enactment of this Act. (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). .

4. Coverage of evidence-based screenings for individuals with a hereditary cancer gene mutation 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: 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. 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). The amendments made by this section shall apply to items and services furnished on or after the date of the enactment of this Act. (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. .