Fertility treatment rights

(a) General rule (1) Individual rights An individual has a statutory right under this Act, without prohibition, limitation, interference, or impediment, to the extent that such prohibition, limitation, interference, or impediment in any way or degree obstructs, delays, or affects commerce over which the Federal Government has jurisdiction, to— (A) receive fertility treatment from a health care provider, in accordance with widely accepted and evidence-based medical standards of care; (B) continue or complete an ongoing fertility treatment previously initiated by a health care provider, in accordance with widely accepted and evidence-based medical standards of care; (C) make decisions and arrangements regarding the donation, testing, use, storage, or disposition of their own reproductive genetic material; and (D) establish contractual agreements with a health care provider relating to the health care provider’s services in handling, testing, storing, shipping, and disposing of the individual’s reproductive genetic material in accordance with widely accepted and evidence-based medical standards of care. (2) Health care provider rights A health care provider has a statutory right under this Act, without prohibition, limitation, interference, or impediment, to the extent that such prohibition, limitation, interference, or impediment in any way or degree obstructs, delays, or affects commerce over which the Federal Government has jurisdiction, to— (A) choose to provide, or assist with the provision of, fertility treatment provided in accordance with widely accepted and evidence-based medical standards of care; (B) continue or complete the provision of, or assistance with, fertility treatment that was lawful when commenced and is provided in accordance with widely accepted and evidence-based medical standards of care; (C) provide for, or assist with, the testing, use, storage, or disposition of reproductive genetic material in accordance with widely accepted and evidence-based medical standards of care; and (D) establish contractual agreements with individuals or manufacturers relating to the health care provider’s services in handling, testing, storing, shipping, and disposing of the individual’s reproductive genetic material. (3) Health insurance issuer rights A health insurance issuer has a statutory right under this Act, without prohibition, limitation, interference, or impediment, to the extent that such prohibition, limitation, interference, or impediment in any way or degree obstructs, delays, or affects commerce over which the Federal Government has jurisdiction, to choose to cover the provision of fertility treatment provided in accordance with widely accepted and evidence-based medical standards of care. (4) Manufacturer rights A manufacturer of a drug or device that is approved, cleared, authorized, or licensed under section 505, 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355; 360(k); 360c(f)(2); 360e) or section 351 of the Public Health Service Act (42 U.S.C. 262) or otherwise legally marketed and intended for use in the provision of fertility treatment, including the storage or transport of reproductive genetic material, has a statutory right under this Act, without prohibition, limitation, interference, or impediment, to the extent that such prohibition, limitation, interference, or impediment in any way or degree obstructs, delays, or affects commerce over which the Federal Government has jurisdiction, to manufacture, import, market, sell, and distribute such drug or device. (b) State regulation of medicine The enforcement of State health and safety law regarding medical facilities or health care providers does not constitute a violation of subsection (a) if— (1) such regulations are in accordance with widely accepted and evidence-based medical standards of care for providing fertility treatment; and (2) the safety or health objective cannot be advanced by a different means that does not prohibit, limit, interfere with, or impede the rights described in subsection (a). (c) Enforcement (1) The Attorney General (A) In general The Attorney General may commence a civil action on behalf of the United States against any State; an individual, employee, official, agency head, contractor, organization, or instrumentality acting for, or on behalf of, such a State; or any individual acting under the color of, or pursuant to, State law, that implements, enforces, or threatens to enforce a limitation or requirement that prohibits, limits, interferes with, or impedes the statutory rights of an individual, a health care provider, a health insurance issuer, or a manufacturer under subsection (a). (B) Effect of violations The court shall hold unlawful and set aside a limitation or requirement described in subparagraph (A) if it is in violation of subsection (a). (2) Private right of action (A) In general Any individual or entity adversely affected by an alleged violation of subsection (a) may commence a civil action against an individual, employee, official, agency head, contractor, organization, or instrumentality acting for, or on behalf of, such a State that enacts, implements, or enforces a limitation or requirement that prohibits, limits, interferes with, or impedes the statutory rights of an individual, a health care provider, a health insurance issuer, or a manufacturer under subsection (a). (B) Effect of violations The court shall hold unlawful and enjoin a limitation or requirement described in subparagraph (A) if it is in violation of subsection (a). (3) Health care provider (A) In general A health care provider may commence a civil action for relief on such provider’s own behalf, on behalf of the provider’s staff, or on behalf of the provider’s patients who are or may be adversely affected by an alleged violation of subsection (a). (B) Effect of violations The court shall hold unlawful and enjoin a limitation or requirement described in subparagraph (A) if it is in violation of subsection (a). (4) Equitable relief In any action under this section, the court may award appropriate equitable relief, including temporary, preliminary, or permanent injunctive relief. (5) Costs (A) In general In any action under this section, the court shall award costs of litigation, as well as reasonable attorney’s fees, to any prevailing plaintiff. (B) Liability of plaintiffs A plaintiff shall not be liable to a defendant for costs or attorney’s fees in any non-frivolous action under this section unless such costs or attorney’s fees are imposed by the court as part of sanctions for violations committed during the discovery process. (6) Jurisdiction The district courts of the United States shall have jurisdiction over proceedings under this section and shall exercise the same without regard to whether the party aggrieved shall have exhausted any administrative or other remedies that may be provided for by law. (7) Right to remove (A) In general Any party shall have a right to remove an action brought under this subsection to the district court of the United States for the district and division embracing the place where such action is pending. (B) Review An order remanding the case to the State court from which it was removed under this paragraph is immediately reviewable by appeal or otherwise. (d) Rules of construction (1) In general For purposes of this Act, a State law, or the administration, implementation, or enforcement of a State law, constitutes a prohibition, limitation, interference, or impediment on a health care provider choosing to provide, an individual choosing to receive, a health insurance issuer choosing to cover, or a manufacturer choosing to market drugs or devices for fertility treatment, provided in accordance with widely accepted and evidence-based medical standards of care, as described in section 4, if the administration, implementation, interpretation, or enforcement of such law has an effect that— (A) imposes requirements or limitations that are inconsistent with providing, receiving, providing health insurance coverage for, or providing drugs or devices for fertility treatment in accordance with widely accepted and evidence-based medical standards of care or that otherwise violate the purpose and requirements of this Act, which may include— (i) requiring that a health care provider provide, and patients undertake, medically unnecessary procedures and services, including tests and procedures, providing medically inaccurate information regarding fertility treatment, or requiring additional unnecessary in-person visits to a health care provider, that are inconsistent with widely accepted and evidence-based medical standards of care; (ii) imposing limitations or requirements concerning physical offices, clinics, facilities, equipment, staffing, or hospital transfer arrangements of facilities where fertility treatment is provided, or the credentials or hospital privileges or status of personnel at such facilities, that are not consistent with widely accepted and evidence-based medical standards of care; or (iii) limiting a health care provider's right or ability to choose to provide, or a patient’s right to choose to receive, or imposing limitations that reduce the efficacy of, fertility treatment in accordance with widely accepted and evidence-based medical standards of care, including retrieval of multiple eggs during oocyte retrieval; performance of insemination procedures, including intrauterine insemination; intracytoplasmic sperm injections to fertilize multiple human eggs; and cryopreservation of one or more eggs or embryos for fertility preservation, if determined appropriate by the health care provider and patient; (B) infringes, limits, or restricts the ability of a health care provider, patient, health insurance issuer, or manufacturer, to exercise or enforce their statutory rights under this Act on the basis of marital status, sex (including sexual orientation and gender identity) or any other protected class that is covered by Federal law; (C) limits a health care provider’s or patient’s right or ability to determine the most appropriate disposition of reproductive genetic materials, including by defining reproductive genetic materials in such a way as to prevent or restrict options for the health care provider or patient; (D) limits a health care provider’s ability to provide, or a patient’s ability to receive, fertility treatment via telemedicine, in accordance with widely accepted and evidence-based medical standards of care; (E) limits or prohibits a health care provider’s ability to provide, or a patient’s ability to receive, fertility counseling or fertility treatment based on the residency of the patient, or prohibits or limits the ability of any individual to assist or support a patient seeking fertility treatment; (F) imposes requirements or limitations that compel health care providers to provide, or patients to receive, medically unnecessary care, or withhold medically necessary care, in a manner that is not consistent with widely accepted and evidence-based medical standards of care for fertility treatment, including mandating the transfer of embryos that a health care provider would not reasonably expect, based on widely accepted and evidence-based medical standards of care, to lead to a healthy pregnancy or a live birth; (G) limits a health care provider’s right or ability to prescribe or dispense, or a patient’s right or ability to receive or use, medications for fertility treatment in accordance with widely accepted and evidence-based medical standards of care, unless such a limitation is generally applicable to the prescription, dispensing, or distribution of medications; or (H) limits a health care provider’s right or ability to perform a human sperm retrieval procedure in accordance with widely accepted and evidence-based medical standards of care. (2) Clarification The descriptions of specific State laws that would violate the statutory rights and protections described in paragraph (1) shall not be construed to limit potential violations of the statutory rights and protections under this Act to only the restrictions and limitations listed in paragraph (1), and potential violations of this Act may result from novel State restrictions and limitations that are not listed under paragraph (1). (3) Exclusion It shall not constitute a prohibition, limitation, interference, or impediment to a health care provider providing, an individual receiving, a health insurance issuer covering, or a manufacturer marketing a drug or device for purposes of, fertility treatment under this Act for an entity to act in compliance with the Food and Drug Administration’s regulation of drugs, devices, biological products, human cells, tissues, or cellular or tissue-based products used in fertility treatment, consistent with widely accepted and evidence-based medical standards of care for fertility treatment.