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119th CongressS. 5554

Introduced in Senate

Ovarian Cancer IMPACT Act

SEC. 1. SHORT TITLETrack this section →

This Act may be cited as the Ovarian Cancer Improving and Modernizing Prevention, Access, Care, and Testing Act or the Ovarian Cancer IMPACT Act.

SEC. 2. FINDINGSTrack this section →

Congress finds the following: (1) Ovarian cancer remains one of the deadliest gynecologic cancers and is frequently diagnosed at an advanced stage. (2) Early recognition of symptoms, access to genetic counseling and testing, and timely referral to specialized care can improve outcomes for individuals diagnosed with ovarian cancer. (3) Significant disparities persist in access to gynecologic oncology services, genetic counseling, hereditary cancer risk assessment, and specialty care, particularly in rural and medically underserved communities. (4) Advances in genetic and genomic science present significant opportunities to improve prevention, early detection, treatment selection, and survivorship outcomes. (5) Hereditary cancer syndromes, including hereditary breast and ovarian cancer syndrome and Lynch syndrome, contribute significantly to ovarian cancer risk and may first be identified following a diagnosis of endometrial cancer. (6) Evidence-based genetic counseling and testing can inform treatment decisions, guide preventive interventions, and identify at-risk family members who may benefit from surveillance or risk-reducing care. (7) Increased public education, provider awareness, and access to specialty care are essential to improving outcomes for individuals affected by ovarian cancer and hereditary cancer syndromes.

SEC. 3. REAUTHORIZATION AND IMPROVEMENT OF JOHANNA’S LAWTrack this section →

Section 317P(d) of the Public Health Service Act (42 U.S.C. 247b–17(d)) is amended— (1) in paragraph (1)— (A) in subparagraph (A), by inserting, in coordination with relevant programs of the Health Resources and Services Administration and the National Cancer Institute, after The Secretary; and (B) by adding at the end the following: (D) Enhanced outreach and education Activities under the national campaign under subparagraph (A) shall include— (i) developing and disseminating culturally and linguistically appropriate public service announcements and educational materials directed toward populations at elevated risk based on race, ethnicity, genetic predisposition, or family history; (ii) conducting targeted outreach activities for populations experiencing elevated risk of ovarian cancer or disparities in outcomes, including populations with hereditary cancer syndromes and populations residing in rural and medically underserved communities; (iii) promoting awareness of hereditary cancer syndromes associated with ovarian cancer risk, including hereditary breast and ovarian cancer syndrome and Lynch syndrome, and the availability of genetic counseling, genetic testing, and evidence-based risk-reducing interventions; (iv) disseminating information regarding coverage and benefits relating to genetic counseling, genetic testing, and risk-reducing interventions available under Federal and private health insurance programs; (v) developing and distributing educational materials for patients and health care professionals regarding current evidence-based guidelines relating to hereditary cancer risk assessment, genetic counseling, genetic testing, and referral to specialty care; and (vi) developing and disseminating information for patients and health care providers on evidence-based ovarian cancer risk-reduction strategies, including opportunistic salpingectomy and the circumstances in which such an intervention may be appropriate.; (2) by inserting after paragraph (4), the following: (5) Demonstration projects (A) In general The Secretary shall award grants to carry out demonstration projects under this subsection to test and evaluate outreach strategies relating to ovarian cancer awareness, hereditary cancer risk assessment, genetic counseling, genetic testing, and access to specialty care. (B) Preference In awarding grants under this paragraph, the Secretary shall give preference to applicants experienced in serving rural, medically underserved, or high-risk populations. (C) Eligible entities Entities eligible to receive a grant under this paragraph shall include State, local, and Tribal public health departments, community health centers, rural hospitals, academic medical centers, nonprofit organizations, and other entities determined appropriate by the Secretary. (D) Reports Not later than 3 years after the date on which grants are awarded under this paragraph, and annually thereafter, the Secretary shall submit to Congress a report that evaluates outcomes of projects carried out under this paragraph. Such reports shall identify barriers to care and contain best practices. and (3) by striking paragraph (6) and inserting the following: (6) Authorization of appropriations For the purpose of carrying out this subsection, there is authorized to be appropriated $20,000,000 for each of fiscal years 2027 through 2031..

SEC. 4. RURAL ACCESS TO OVARIAN CANCER CARETrack this section →

(a) Rural health care services outreach grants Section 330A(e) of the Public Health Service Act (42 U.S.C. 254c(e)) is amended— (1) in paragraph (1), by inserting, including with respect to ovarian cancer prevention, diagnosis, treatment, survivorship services, hereditary cancer risk assessment, genetic counseling, and care coordination, after delivery of health care services; and (2) in paragraph (2)(A), by inserting or Tribal communities before the semicolon. (b) Expanding capacity for health outcomes Section 330N(b) of the Public Health Service Act (42 U.S.C. 254c–20(b)) is amended by inserting ovarian cancer, after palliative care,.

SEC. 5. STANDARDS RELATING TO BENEFITS FOR GENETIC AND GENOMIC TESTING FOR, EARLY DETECTION OF, AND RISK-REDUCING INTERVENTIONS WITH RESPECT TO OVARIAN CANCERTrack this section →

(a) In general Part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg et seq.) is amended by inserting after section 2729 the following new section: 2729A. Standards relating to benefits for genetic and genomic testing for, early detection of, and risk-reducing interventions with respect to ovarian cancer (a) Coverage relating to benefits for genetic and genomic testing (1) In general A group health plan, or a health insurance issuer offering group or individual health insurance coverage, shall provide coverage to an enrollee— (A) who— (i) has a personal history of ovarian cancer; (ii) has a personal history of endometrial cancer for whom genetic counseling or genetic testing is recommended under evidence-based clinical practice guidelines developed by the National Comprehensive Cancer Network, the American Society of Clinical Oncology, or the Society of Gynecologic Oncology; or (iii) has a family history indicative of hereditary ovarian cancer, Lynch syndrome, or another hereditary cancer syndrome associated with increased ovarian cancer risk; and (B) for— (i) genetic counseling by a certified provider (in person or via telehealth); (ii) multi-gene panel testing for germline genetic mutations using next-generation sequencing or other comparable advanced diagnostic testing technologies, as applicable; (iii) single syndrome, single-gene mutation testing, or targeted mutation testing if determined by the attending health care provider to be more appropriate; and (iv) tumor genomic profiling or biomarker testing for somatic mutations using next-generation sequencing, or other comparable advanced diagnostic testing technology, as applicable. (2) Scope of testing Testing required under this subsection shall include testing to detect— (A) genetic mutations in BRCA1 and BRCA2 genes; (B) genetic mutations associated with Lynch syndrome; (C) mismatch repair deficiency, microsatellite instability, and other biomarkers recommended under evidence-based clinical practice guidelines for identification of Lynch syndrome or other hereditary cancer syndromes associated with increased ovarian cancer risk; (D) rearrangement analysis of all coding exons associated with ovarian cancer; and (E) additional mutations, including mutations in the BRIP1, RAD51C, and RAD51D genes, in accordance with evidence-based clinical practice guidelines addressing genetic testing, screening, and management of individuals with a personal history of ovarian cancer or a family history indicating or suspicious for increased ovarian cancer risk developed by the National Comprehensive Cancer Network, the American Society of Clinical Oncology, the Society of Gynecologic Oncology, or another nationally recognized oncology professional organization. (3) Application of guidelines In administering paragraph (2) in the case of conflicting guidelines developed by more than one nationally recognized oncology professional organization, the least restrictive of such guidelines shall apply. (4) Repeat or expanded testing A group health plan or health insurance issuer shall provide coverage of repeat or expanded testing if medically necessary and appropriate, as determined by the treating health care provider. (b) Coverage for early detection and risk-Reducing interventions A group health plan, and a health insurance issuer offering group or individual health insurance coverage, shall provide coverage for evidence-based early detection, hereditary cancer risk management, risk-reducing surgeries, and other interventions intended to reduce the risk of ovarian cancer in individuals identified as being at elevated hereditary risk where indicated under nationally recognized oncology professional organization guidelines. Coverage under this subsection shall be provided regardless of whether the enrollee has a personal history of ovarian cancer or endometrial cancer. (c) Rule of construction Nothing in this section shall be construed to require an enrollee to receive testing, early detection, or risk-reducing interventions described in this section. (d) Level and type of reimbursements Nothing in this section shall be construed to prevent a group health plan or health insurance issuer from negotiating the level and type of reimbursement with a provider for care provided in accordance with this section. (e) Provider education and implementation The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Administrator of the Health Resources and Services Administration, shall support activities to increase awareness among health care professionals regarding— (1) evidence-based guidelines for genetic counseling and genetic testing in individuals diagnosed with ovarian cancer or endometrial cancer; (2) collection and assessment of family cancer history; (3) appropriate referral pathways for genetic counseling and specialty care; and (4) coverage protections established under this section. (f) Evaluation The Secretary shall evaluate activities conducted under this section, including— (1) providing for public awareness of ovarian cancer symptoms and hereditary cancer risk factors; (2) providing provider awareness of evidence-based genetic counseling and testing guidelines; (3) the utilization of genetic counseling and testing services; (4) ensuring access to services in rural and medically underserved communities; and (5) whether barriers exist to the implementation of this section. (g) Privacy protections The Secretary shall ensure that this section is carried out in a manner that complies with all applicable Federal and State privacy laws.. (b) Application to grandfathered health plans Section 1251(a)(4)(A) of the Patient Protection and Affordable Care Act (42 U.S.C. 18011(a)(4)(A)) is amended— (1) in the matter preceding clause (i), by striking (as added by this title); and (2) by adding at the end the following: (v) Section 2729A (relating to standards relating to benefits for genetic and genomic testing for, early detection of, and risk-reducing interventions with respect to ovarian cancer).. (c) Effective date The amendments made by this section shall apply with respect to plan years beginning on or after the date that is 1 year after the date of enactment of this Act.

SEC. 6. IMPLEMENTATION AND REPORTINGTrack this section →

(a) Implementation plan Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to Congress an implementation plan outlining timelines, agency responsibilities, and performance benchmarks with respect to the amendments made by this Act. (b) Report Not later than 3 years after the date of enactment of this Act, and every 3 years thereafter through fiscal year 2032, the Secretary of Health and Human Services shall submit to Congress a report that describes— (1) implementation activities under the amendments made by this Act; (2) the utilization of genetic counseling and testing services under such amendments; (3) the utilization of risk-reducing interventions under such amendments; (4) progress made in improving access to ovarian cancer care in rural and medically underserved communities; and (5) recommendations for further legislative or administrative action.

•S 5554 ISText from GovInfo
S. 5554 full text: Ovarian Cancer IMPACT Act · Public Law Tracker