Standards relating to benefits for genetic and genomic testing for, early detection of, and risk-reducing interventions with respect to ovarian cancer
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(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.