[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 5258 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
2d Session
S. 5258
To amend title XI of the Social Security Act to establish a payment
model to reimburse providers for furnishing comprehensive breast cancer
risk assessments and developing personalized screening and risk-
reduction plans, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
August 5, 2026
Mr. Cassidy (for himself and Ms. Murkowski) introduced the following
bill; which was read twice and referred to the Committee on Finance
_______________________________________________________________________
A BILL
To amend title XI of the Social Security Act to establish a payment
model to reimburse providers for furnishing comprehensive breast cancer
risk assessments and developing personalized screening and risk-
reduction plans, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Personalized Risk Evaluation For
Effective Risk Reduction and Early Detection Screening Act'' or the
``PREFERRED Screening Act''.
SEC. 2. CMI MODEL TO TEST REIMBURSING ELIGIBLE PROVIDERS FOR FURNISHING
COMPREHENSIVE BREAST CANCER RISK ASSESSMENTS AND
DEVELOPING PERSONALIZED SCREENING AND RISK REDUCTION
PLANS.
Section 1115A of the Social Security Act (42 U.S.C. 1315a) is
amended--
(1) in subsection (b)(2)(A), by adding at the end the
following new sentence: ``The models selected under this
subparagraph shall include the model described in subsection
(h).''; and
(2) by adding at the end the following new subsection:
``(h) Testing Reimbursing Providers for Furnishing Comprehensive
Breast Cancer Risk Assessments and Developing Personalized Screening
and Risk Reduction Plans.--
``(1) Purpose and establishment.--
``(A) In general.--Not later than 2 years after the
date of enactment of this subsection, the Secretary
shall implement a payment model (referred to in this
subsection as the `Model') to reimburse eligible
providers (as defined in paragraph (11)) for furnishing
comprehensive breast cancer risk assessments to
eligible individuals (as defined in such paragraph),
and for developing personalized screening and risk-
reduction plans based on such assessments.
``(B) Purpose.--The purpose of the Model is to test
whether reimbursing eligible providers for furnishing
comprehensive breast cancer risk assessments and
developing personalized screening and risk-reduction
plans changes the furnishing of breast cancer screening
and risk-reduction services to eligible individuals.
``(C) Beginning of model.--For purposes of this
subsection, the Model shall be treated as having begun
on the date on which the first eligible individual
receives a comprehensive breast cancer risk assessment
furnished under the Model.
``(D) Notification requirement if there is a
delay.--If the Model has not begun by the date that is
2 years after the date of enactment of this subsection,
the Secretary shall notify the relevant committees of
the reasons for the delay and of the expected date on
which the Model will begin.
``(E) Rule of construction.--Nothing in this
subsection shall be construed to require the Secretary
to establish the clinical efficacy of risk-stratified
breast cancer screening.
``(2) Comprehensive breast cancer risk assessments and
personalized screening and risk-reduction plans.--
``(A) Comprehensive breast cancer risk
assessments.--
``(i) In general.--A comprehensive breast
cancer risk assessment described in paragraph
(1) shall--
``(I) collect the information
described in clause (ii);
``(II) using a validated risk
model, produce an estimate of an
eligible individual's 5-year risk of
developing breast cancer, supplemented
by the results of multigene panel
testing and a polygenic risk score; and
``(III) on the basis of such
estimate and the results of multigene
panel testing, assign such eligible
individual to a risk category. Such
risk categories shall include at
minimum a high-risk category and an
elevated-risk category and be
established by the Secretary.
``(ii) Information collected.--The
information described in this clause, with
respect to an eligible individual, is--
``(I) the results of genetic
testing, including multigene panel
testing for the BRCA1, BRCA2, PALB2,
CDH1, TP53, PTEN, STK11, ATM, and CHEK2
genes and such other breast cancer
susceptibility genes as the Secretary
determines appropriate;
``(II) a polygenic risk score;
``(III) the family history of the
eligible individual with respect to
breast cancer and related cancers;
``(IV) breast density, as
determined under mammographic imaging;
``(V) clinical and lifestyle risk
factors; and
``(VI) such other information as
the Secretary determines appropriate.
``(B) Personalized screening and risk-reduction
plan.--A personalized screening and risk reduction plan
described in paragraph (1) shall include--
``(i) recommendations regarding--
``(I) adjusted cancer screening
frequency and modality (such as
mammography, magnetic resonance imaging
(referred to in this subsection as
`MRI'), and ultrasounds) based on an
individual's risk level;
``(II) referrals for enhanced
surveillance imaging, including breast
MRIs, for high-risk individuals (as
defined in paragraph (11));
``(III) risk reduction counseling
on modifiable factors, such as weight
management, physical activity, and
alcohol consumption;
``(IV) counseling for a high-risk
individual regarding endocrine risk-
reducing medications, such as
tamoxifen, raloxifene, and aromatase
inhibitors;
``(V) referrals for genetic
counseling following pathogenic, likely
pathogenic, or uncertain significance
findings based on test results; and
``(VI) when such individual should
be reassessed based on changes in risk
factors, updated risk models, or
reclassification of genetic variants;
``(ii) notifying first-degree relatives who
may benefit from genetic testing; and
``(iii) communicating the personalized
screening and risk-reduction plan to the
individual's primary care provider and
integrating such plan into the individual's
medical record.
``(3) Delivery approaches.--The Secretary shall ensure that
the Model allows eligible providers to furnish comprehensive
breast cancer risk assessments through--
``(A) traditional in-person office visits; and
``(B) remote means, including allowing such
providers to collect genetic testing specimens through
kits mailed to an eligible individual's home.
``(4) Site selection.--
``(A) In general.--The Secretary shall ensure that
the eligible providers participating in the Model
include a mix of academic medical centers, community-
based practices, and facilities serving rural
populations.
``(B) Application.--An eligible provider seeking to
enroll in the Model shall submit to the Secretary an
application for enrollment containing such
requirements, at such time, and in such manner, as
specified by the Secretary.
``(C) Selection of eligible providers.--In
selecting eligible providers to participate in the
Model, the Secretary shall prioritize such providers--
``(i) located in the 10 States with the
highest breast cancer mortality rate among
women;
``(ii) located in an area designated as a
health professional shortage area under section
332(a)(1)(A) of the Public Health Service Act;
``(iii) located in a medically underserved
area or that serve medically underserved
populations (as defined in section 330(b)(3) of
such Act); or
``(iv) located in a rural area (as defined
in section 1886(d)(2)(D)) whose population has
limited access to genetic counseling services
or comprehensive breast cancer risk
assessments.
``(D) Data sharing.--In selecting eligible
providers to participate in the Model, the Secretary
may give preference to eligible providers who use
laboratories that submit de-identified variant data,
including variants of uncertain significance, to the
ClinVar public database maintained by the National
Center for Biotechnology Information.
``(5) Payment.--
``(A) In general.--The Secretary shall establish a
payment amount for the furnishing of a comprehensive
breast cancer risk assessment and personalized
screening and risk reduction plan under the Model.
``(B) Considerations.--In determining the payment
amount described in subparagraph (A), the Secretary
shall consider--
``(i) the clinical time and complexity of
the services furnished;
``(ii) the interpretation of genetic
testing results, polygenic risk scores, and
breast density data;
``(iii) the time required for the
development of personalized screening and risk
reduction plans; and
``(iv) comparable comprehensive assessment
and prevention-planning services under the
physician fee schedule under title XVIII.
``(C) Adjustment.--The Secretary may adjust the
payment amount established under subparagraph (A)
during the period of the Model on the basis of the
evaluation described in paragraph (6)(A)(vi).
``(6) Evaluation.--The Secretary shall evaluate the Model
from claims data and from the personalized screening and risk-
reduction plans developed under the Model by the following
measures that the Secretary shall stratify by age band:
``(A) Primary measures.--The Secretary shall
evaluate--
``(i) the proportion of eligible
individuals who receive a comprehensive breast
cancer risk assessment under the Model;
``(ii) whether the services recommended in
an eligible individual's personalized screening
and risk-reduction plan have been furnished to
such individual;
``(iii) the extent to which screening
mammography frequency and modality vary across
the risk categories established under paragraph
(2)(A)(i)(III);
``(iv) breast MRI utilization among high-
risk individuals;
``(v) utilization of endocrine risk-
reducing medications, such as tamoxifen,
raloxifene, and aromatase inhibitors, among
high-risk individuals and individuals assigned
to an elevated risk category;
``(vi) whether the payment amount is
sufficient to sustain eligible provider
participation in the Model; and
``(vii) the number of eligible providers
who continue to participate in the Model.
``(B) Secondary measures.--The Secretary shall
evaluate--
``(i) the total cost of care for breast
cancer screening and treatment episodes among
participating eligible individuals, benchmarked
against national utilization and spending for
individuals comparable to eligible individuals;
``(ii) the projected cost-effectiveness of
the Model over a 10-year and 20-year horizon,
including the estimated value of cancers
prevented, cancers detected at earlier stages,
and screening procedures avoided;
``(iii) the proportion of comprehensive
breast cancer risk assessments that integrate
each item of information described in paragraph
(2)(A)(ii);
``(iv) the rate at which personalized
screening and risk reduction plans are
developed and communicated to the primary care
providers of eligible individuals;
``(v) the average time from when an
eligible individual first receives a
comprehensive breast cancer risk assessment to
the time such individual receives a
personalized screening and risk reduction plan;
``(vi) the rate at which eligible
individuals adhere to the recommendations in
their personalized screening and risk reduction
plan;
``(vii) whether there are any differences
in the measures described in this subparagraph
between different delivery approaches and
eligible providers; and
``(viii) reported outcomes of eligible
individuals, including the satisfaction of
eligible individuals with the personalized
screening and risk reduction plan furnished to
such individuals, the understanding of the
personal risk level of eligible individuals,
and the anxiety and decisional conflict of
eligible individuals, measured using validated
patient-reported outcome instruments.
``(C) Exploratory measures.--The Secretary shall
evaluate, among participating eligible individuals--
``(i) the rate of--
``(I) stage IIB or higher breast
cancers; and
``(II) stage IIA breast cancers;
``(ii) the rate of ductal carcinoma in situ
(DCIS) detection; and
``(iii) the proportion of breast cancers
detected through screening compared to the
number of breast cancers detected through
symptomatic presentation.
``(7) Additional authority.--If the Secretary determines
that additional statutory authority is required to test or
expand the Model, not later than 180 days after making such
determination, the Secretary shall notify the Committee on
Finance of the Senate and the Committee on Ways and Means of
the House of Representatives.
``(8) Termination.--
``(A) In general.--The Model shall terminate on the
date that is 7 years after the date on which the Model
begins, unless the Secretary determines that expansion
of the Model is appropriate under subsection (c).
``(B) Authority.--The Secretary may not terminate
the Model under subsection (b)(3)(B) until after the
date on which the Secretary submits the interim report
described in paragraph (9)(A).
``(9) Reports.--
``(A) Interim report.--Not later than the date that
is 3 years after the commencement of the Model, the
Secretary shall submit to the relevant committees, the
Director of the Agency for Healthcare Research and
Quality, and the United States Preventive Services Task
Force an interim report describing--
``(i) the measures used to evaluate the
Model under paragraph (6); and
``(ii) the rate of laboratories used by
eligible providers that submit de-identified
variant data to the ClinVar public database
maintained by the National Center for
Biotechnology Information.
``(B) Final report.--Not later than the date that
is 7 years after the commencement of the Model, the
Secretary shall submit to the relevant committees, the
Director of the Agency for Healthcare Research and
Quality, and the United States Preventive Services Task
Force a final report--
``(i) describing the measures used to
evaluate the Model under paragraph (6);
``(ii) the rate of laboratories used by
eligible providers that submit de-identified
variant data to the ClinVar public database
maintained by the National Center for
Biotechnology Information; and
``(iii) with recommendations regarding
whether the model should be expanded or made
permanent, including whether the Model should
be expanded to individuals enrolled in a
Medicare Advantage plan under part C of title
XVIII.
``(C) United states preventive services task
force.--If, after the date of enactment of this Act,
the United States Preventive Services Task Force issues
an updated recommendation addressing breast cancer risk
assessment or germline genetic testing, the Secretary
shall--
``(i) evaluate the effect on such
recommendation on the design and evaluation of
the Model, including whether any modification
of the Model is warranted; and
``(ii) not later than 180 days after the
United States Preventive Services Task Force
issues such recommendation, submit to the
relevant committees a report describing such
evaluation.
``(10) Funding.--No additional funds are authorized to be
appropriated to carry out this subsection. The Secretary shall
carry out the Model using funds otherwise available under
subsection (f).
``(11) Definitions.--In this subsection:
``(A) Eligible individual.--The term `eligible
individual' means an individual--
``(i) entitled to, or enrolled for,
benefits under part A of title XVIII, or
enrolled for benefits under part B of such
title, but not enrolled in a plan under part C
of such title;
``(ii) who has attained 40 years of age but
has not attained 75 years of age;
``(iii) who does not have end-stage renal
disease; and
``(iv) who is not receiving hospice care
under title XVIII.
``(B) Eligible provider.--
``(i) In general.--The term `eligible
provider' means--
``(I) a physician (as defined in
section 1861(r)(1));
``(II) a certified nurse-midwife
(as defined in section 1861(gg));
``(III) a nurse practitioner (as
defined in section 1861(aa)(5)(A));
``(IV) a physician assistant (as
defined in such section);
``(V) a genetic counselor who is
certified by the American Board of
Genetic Counseling or the American
Board of Medical Genetics and Genomics;
or
``(VI) any other qualified health
professional determined appropriate by
the Secretary.
``(ii) Clarification.--An individual
described in clause (i) shall be considered an
eligible provider without regard to whether
such individual is otherwise recognized as a
supplier under title XVIII.
``(C) High-penetrance gene.--The term `high-
penetrance gene' means the BRCA1, BRCA2, PALB2, CDH1,
TP53, PTEN, or STK11 gene, and any such other gene as
the Secretary determines to confer comparable risk.
``(D) High-risk individual.--The term `high-risk
individual' means an individual--
``(i) whose 5-year risk of developing
breast cancer, as estimated by a validated risk
model, is 6 percent or greater;
``(ii) who has a pathogenic variant in a
high-penetrance gene; or
``(iii) who possesses such other criteria
that the Secretary determines to be
appropriate, consistent with applicable
clinical practice guidelines.
``(E) Relevant committees.--The term `relevant
committees' means the Committee on Finance and the
Committee on Health, Education, Labor, and Pensions of
the Senate, the Committee on Ways and Means and the
Committee on Energy and Commerce of the House of
Representatives.
``(F) Validated risk model.--The term `validated
risk model' means a model that--
``(i) produces an estimate of an
individual's 5-year risk of developing breast
cancer; and
``(ii) the Secretary determines has been
validated in a population comparable to
eligible individuals.''.
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