What This Bill Does
This bill changes Medicare coverage to pay for genetic testing in people with a family history of hereditary cancer or symptoms suggesting hereditary cancer. It also allows Medicare to cover cancer screening tests and preventive surgeries for people who have inherited cancer-risk gene mutations.
Who It Affects
Medicare beneficiaries (people age 65 and older, some younger disabled people, and some people with end-stage renal disease) who have a family history of hereditary cancer gene mutations or personal or family history suspicious for hereditary cancer.
Key Provisions
• Medicare must cover genetic testing for inherited cancer mutations in individuals with a personal or family history of hereditary cancer gene mutations or a personal or family history suspicious for hereditary cancer (Sec. 2(a))
• The genetic testing must follow evidence-based clinical practice guidelines (medical standards based on scientific evidence) from nationally recognized cancer organizations like the National Comprehensive Cancer Network or the American Society of Clinical Oncology, or if guidelines conflict, the least restrictive version applies (Sec. 2(a))
• Medicare can deny coverage only if someone receives the same germline mutation test more than once for the same individual (Sec. 2(b))
• Risk-reducing surgeries (operations to prevent cancer development) are considered reasonable and necessary when evidence-based guidelines show surgery would lower cancer risk (Sec. 3)
• Medicare must increase how often it pays for cancer screening tests like mammography (breast X-rays), breast MRI (magnetic resonance imaging), colonoscopy (viewing inside the colon), and PSA testing (prostate cancer blood test) for people with hereditary cancer gene mutations, at minimum once yearly (Sec. 4(a))
What Changes
Medicare currently does not cover hereditary cancer genetic testing or adjust coverage frequency for cancer screenings based on hereditary cancer status. This bill requires Medicare to pay for this genetic testing, cover preventive surgeries for people with inherited cancer mutations, and increase coverage for cancer screening tests at least annually for eligible individuals.
Important Definitions
• Germline mutation testing: genetic testing for inherited mutations that follows nationally recognized cancer organization guidelines and addresses how to test, screen and manage people with inherited mutations linked to increased cancer risk (Sec. 2(a))
• Evidence-based screenings: screening tests including screening mammography, breast MRI, colonoscopy, PSA testing, and other screening methods appropriate for high-risk individuals as recommended by clinical practice guidelines (Sec. 4(a))
Effective Date
The genetic testing coverage takes effect on the date this bill becomes law (Sec. 2(c)). The preventive surgery coverage takes effect on the date this bill becomes law (Sec. 3(b)). The screening coverage takes effect on the date this bill becomes law (Sec. 4(c)).
II
118TH CONGRESS
1ST SESSION
S. 765
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 SENATE OF THE UNITED STATES
MARCH 9, 2023
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 re-
duce the risk for individuals with a germline (inherited)
mutation associated with a high risk of developing a
preventable cancer.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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•S 765 IS
SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Reducing Hereditary
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Cancer Act of 2023’’.
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SEC. 2. HEREDITARY CANCER GENETIC TESTING OF INDI-
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VIDUALS WITH A FAMILY HISTORY OF A HE-
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REDITARY CANCER GENE MUTATION OR PER-
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SONAL OR FAMILY HISTORY SUSPICIOUS FOR
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HEREDITARY CANCER.
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(a) COVERAGE.—Section 1861 of the Social Security
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Act (42 U.S.C. 1395x) is amended—
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(1) in subsection (s)(2)—
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(A) in subparagraph (II), by striking
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‘‘and’’ at the end;
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(B) in subparagraph (JJ), by inserting
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‘‘and’’ at the end; and
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(C) by adding at the end the following new
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subparagraph:
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‘‘(KK) in the case of an individual with a per-
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sonal or family history of a hereditary cancer gene
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mutation or a personal or family history suspicious
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for hereditary cancer, germline mutation testing;’’;
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and
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(2) by adding at the end the following new sub-
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section:
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‘‘(nnn) GERMLINE MUTATION TESTING.—The term
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‘germline mutation testing’ means genetic testing for
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•S 765 IS
germline mutations that is in accordance with evidence-
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based, clinical practice guidelines specifically addressing
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genetic testing, screening, and management of individuals
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with inherited mutations associated with increased cancer
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risk that—
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‘‘(1) have been developed by a nationally recog-
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nized oncology professional organization, including
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the National Comprehensive Cancer Network, the
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American Society of Clinical Oncology, the Society
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of Gynecologic Oncology, or any other oncology pro-
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fessional organization specified by a medicare ad-
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ministrative contractor with a contract under section
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1874A; and
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‘‘(2) in the case of conflicting guidelines devel-
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oped by more than one nationally recognized oncol-
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ogy professional organization, are the least restric-
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tive of such guidelines, as determined by such a
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medicare administrative contractor.’’.
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(b) FREQUENCY.—Section 1862(a)(1) of the Social
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Security Act (42 U.S.C. 1395y(a)(1)) is amended—
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(1) by striking ‘‘and’’ at the end of subpara-
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graph (O);
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(2) by adding ‘‘and’’ at the end of subpara-
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graph (P); and
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•S 765 IS
(3) by adding at the end the following new sub-
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paragraph:
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‘‘(Q) in the case of germline mutation testing
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as defined in section 1861(nnn), which is performed
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more than once with respect to an individual de-
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scribed in such section;’’.
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(c) EFFECTIVE DATE.—The amendments made by
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this section shall apply to testing furnished on or after
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the date of the enactment of this Act.
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SEC. 3. COVERAGE OF CERTAIN PREVENTIVE SURGERIES.
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(a) IN GENERAL.—Section 1862 of the Social Secu-
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rity Act (42 U.S.C. 1395y) is amended by adding at the
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end the following new subsection:
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‘‘(p) COVERAGE OF CERTAIN RISK-REDUCING SUR-
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GERIES.—In the case of an individual described in section
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1861(s)(2)(JJ) for whom, based on evidence-based, clin-
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ical practice guidelines described in section 1861(nnn),
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surgery would reduce the risk of developing cancer, such
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risk-reducing surgery shall be considered reasonable and
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necessary for treatment of illness under subsection
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(a)(1)(A).’’.
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(b) EFFECTIVE DATE.—The amendment made by
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subsection (a) shall apply to items and services furnished
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on or after the date of the enactment of this Act.
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•S 765 IS
SEC. 4. COVERAGE OF EVIDENCE-BASED SCREENINGS FOR
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INDIVIDUALS WITH A HEREDITARY CANCER
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GENE MUTATION.
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(a) IN GENERAL.—Section 1862 of the Social Secu-
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rity Act (42 U.S.C. 1395y), as amended by section 3, is
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amended by adding at the end the following new sub-
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section:
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‘‘(q) COVERAGE OF EVIDENCE-BASED SCREENINGS
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FOR INDIVIDUALS WITH A HEREDITARY CANCER GENE
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MUTATION.—In the case of an individual who is deter-
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mined pursuant to genetic testing to have a hereditary
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cancer (germline) gene mutation, the Secretary shall in-
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crease any frequency limitations (or other limitations on
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coverage otherwise applicable under this title) for any evi-
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dence-based screenings furnished to such individual, to be
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in compliance with evidence-based, clinical practice guide-
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lines described in section 1861(nnn), or as determined ap-
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propriate by the Secretary, but not less frequently than
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on an annual basis. For the purposes of this subsection,
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evidence-based screenings shall include screening mam-
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mography, breast screening MRI, colonoscopy, PSA test-
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ing, and any additional evidence-based screening modali-
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ties appropriate for high-risk individuals as recommended
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by such guidelines.’’.
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(b) CONFORMING
AMENDMENT
FOR
SCREENING
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MAMMOGRAPHY.—Section 1834(c)(2)(A) of the Social Se-
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•S 765 IS
curity Act (42 U.S.C. 1395m(c)(2)(A)) is amended, in the
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matter preceding clause (i), by striking ‘‘subparagraph
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(B)’’ and inserting ‘‘subparagraph (B) and section
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1862(q)’’.
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(c) EFFECTIVE DATE.—The amendments made by
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this section shall apply to items and services furnished on
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or after the date of the enactment of this Act.
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Æ
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