Right to assisted reproductive technology and intrauterine insemination rights

(a) General rule (1) Individual rights An individual has a statutory right under this title, 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 ART or IUI from a health care provider; (B) continue or complete an ongoing ART or IUI service previously initiated by a health care provider; (C) make decisions and arrangements regarding the donation, testing, use, storage, or disposition of reproductive genetic material, such as oocytes, sperm, fertilized eggs, and embryos; 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. (2) Health care provider rights A health care provider has a statutory right under this title, 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) provide, or assist with the provision of, ART or IUI; (B) continue or complete the provision of, or assistance with, ART or IUI that was lawful when commenced; (C) provide for, or assist with, the testing, use, storage, or disposition of reproductive genetic material, such as oocytes, sperm, fertilized eggs, and embryos; 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 title, 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 cover the provision of ART or IUI. (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 ART or IUI, including the storage or transport of oocytes, gametes, fertilized eggs, and embryos, has a statutory right under this title, 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 consistent with guidance from the American Society for Reproductive Medicine for providing ART or IUI; 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) Regulations Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate regulations to carry out this section. (e) Rules of construction (1) In general For purposes of this title, 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 providing, an individual receiving, a health insurance issuer covering, or a manufacturer marketing drugs or devices for ART or IUI, as described in subsection 104, 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 ART or IUI 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 ART or IUI, or requiring additional unnecessary in-person visits to a health care provider; (ii) imposing limitations or requirements concerning physical offices, clinics, facilities, equipment, staffing, or hospital transfer arrangements of facilities where ART or IUI are provided, or the credentials or hospital privileges or status of personnel at such facilities; or (iii) limiting a health care provider’s right or ability to provide, or a patient’s right to receive, continue or complete ART or IUI, or imposing limitations that reduce the efficacy of, ART or IUI, including limitations on— (I) retrieval of multiple eggs during oocyte retrieval; (II) intracytoplasmic sperm injections to fertilize multiple human eggs; and (III) cryopreservation of one or more eggs, sperm, or embryos 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 title 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 material, including by defining a gamete or embryo in such a way to limit an individual’s options for how their reproductive genetic material should be handled; (D) limits a health care provider’s ability to provide, or a patient’s ability to receive, ART or IUI via telemedicine; (E) limits or prohibits a health care provider’s ability to provide, or a patient’s ability to receive, counseling regarding ART or IUI based on the residency of the patient, or prohibits or limits the ability of any individual to assist or support a patient seeking ART or IUI; (F) imposes requirements or limitations that compel health care providers to provide, or patients to receive, medically unnecessary care, or withhold medically necessary care, including mandating the transfer of embryos that a health care provider would not reasonably expect, based on American Society for Reproductive Medicine guidelines, to lead to a pregnancy or a live birth; or (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 ART or IUI, unless such a limitation is generally applicable to the prescription, dispensing, or distribution of medications. (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 title to only the restrictions and limitations listed in paragraph (1), and potential violations of this title 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, ART or IUI under this title 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 ART or IUI.