(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.