•HRES 1346 IH 
tients 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 equi-
table relief, including temporary, preliminary, or per-
manent injunctive relief. 
(5) COSTS.— 
(A) IN
GENERAL.—In any action under 
this section, the court shall award costs of liti-
gation, as well as reasonable attorney’s fees, to 
any prevailing plaintiff. 
(B) LIABILITY OF PLAINTIFFS.—A plain-
tiff 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 attor-
ney’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 pro-
ceedings under this section and shall exercise the 
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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 re-
moved under this paragraph is immediately re-
viewable 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 Act, a 
State law, or the administration, implementation, or 
enforcement of a State law, constitutes a prohibi-
tion, limitation, interference, or impediment on a 
health care provider providing, an individual receiv-
ing, a health insurance issuer covering, or a manu-
facturer marketing drugs or devices for fertility 
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•HRES 1346 IH 
treatment, provided in accordance with widely ac-
cepted and evidence-based medical standards of care 
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 pro-
viding drugs or devices for fertility treatment in 
accordance with widely accepted and evidence- 
based medical standards of care or that other-
wise violate the requirements of this Act, which 
may include— 
(i) requiring that a health care pro-
vider provide, and patients undertake, 
medically unnecessary procedures and serv-
ices, including tests and procedures, pro-
viding medically inaccurate information re-
garding 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 require-
ments concerning physical offices, clinics, 
facilities, equipment, staffing, or hospital 
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transfer arrangements of facilities where 
fertility treatment is provided, or the cre-
dentials or hospital privileges or status of 
personnel at such facilities, that are not 
consistent with widely accepted and evi-
dence-based medical standards of care; or 
(iii) limiting a health care provider’s 
right or ability to provide, or a patient’s 
right to receive, or imposing limitations 
that reduce the efficacy of, fertility treat-
ment in accordance with widely accepted 
and evidence-based medical standards of 
care, including retrieval of multiple eggs 
during oocyte retrieval; performance of in-
semination procedures, including intra-
uterine 
insemination; 
intracytoplasmic 
sperm 
injections 
to 
fertilize 
multiple 
human eggs; and cryopreservation of one 
or more eggs or embryos for fertility pres-
ervation and subsequent transfer, if deter-
mined appropriate by the health care pro-
vider and patient; 
(B) infringes, limits, or restricts the ability 
of a health care provider, patient, health insur-
ance issuer, or manufacturer, to exercise or en-
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force their statutory rights under this Act on 
the basis of marital status, sex (including sex-
ual orientation and gender identity) or any 
other protected class that is covered by Federal 
law; 
(C) limits a health care provider’s or pa-
tient’s right or ability to determine the most ap-
propriate disposition of fertilized eggs or em-
bryos, including by defining a gamete or em-
bryo in such a way as to prevent the disposition 
of gametes and embryos; 
(D) limits a health care provider’s ability 
to provide, or a patient’s ability to receive, fer-
tility treatment via telemedicine, in accordance 
with widely accepted and evidence-based med-
ical standards of care; 
(E) limits or prohibits a health care pro-
vider’s ability to provide, or a patient’s ability 
to receive, fertility counseling or fertility treat-
ment 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 
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patients to receive, medically unnecessary care, 
or withhold medically necessary care, in a man-
ner 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 ap-
plicable to the prescription, dispensing, or dis-
tribution of medications; or 
(H) limits a health care provider’s right or 
ability to perform a human sperm retrieval pro-
cedure in accordance with widely accepted and 
evidence-based medical standards of care. 
(2) CLARIFICATION.—The descriptions of spe-
cific State laws that would violate the statutory 
rights and protections described in paragraph (1) 
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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 limita-
tions that are not listed under paragraph (1). 
(3) EXCLUSION.—It shall not constitute a pro-
hibition, limitation, interference, or impediment to a 
health care provider providing, an individual receiv-
ing, a health insurance issuer covering, or a manu-
facturer 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 Administra-
tion’s regulation of drugs, devices, biological prod-
ucts, human cells, tissues, or cellular or tissue-based 
products used in fertility treatment, consistent with 
widely accepted and evidence-based medical stand-
ards of care for fertility treatment. 
SEC. 5. APPLICABILITY AND PREEMPTION. 
(a) IN GENERAL.— 
(1) GENERAL APPLICATION.— 
(A) EFFECT ON STATE LAW.—This Act su-
persedes any State law that is inconsistent with 
the statutory rights established under this Act 
and precludes the implementation of such a 
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law, whether statutory, common law, or other-
wise, and whether adopted before or after the 
date of enactment of this Act. 
(B) PROHIBITION.—No State shall admin-
ister, implement, or enforce any law, rule, regu-
lation, standard, or other provision having the 
force and effect of law that conflicts with any 
provision of this Act, notwithstanding any other 
provision of Federal law. 
(2) EXCLUSION.—Preemption of State law 
under paragraph (1) does not apply to— 
(A) State law regarding the resolution of 
disputes between 2 individuals with rights de-
scribed in section 4(a)(1) with respect to the 
same reproductive genetic material, such as oo-
cytes, sperm, fertilized eggs, and embryos; or 
(B) any other State law, to the extent that 
such law does not conflict with this Act and 
protects an individual’s right and ability to re-
ceive fertility treatment in accordance with 
widely accepted and evidence-based medical 
standards of care, including any such law that 
holds a health care provider accountable for not 
providing fertility treatment in accordance with 
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widely accepted and evidence-based medical 
standards of care. 
(3) 
PRESERVATION
OF
FEDERAL
PUBLIC 
HEALTH AUTHORITIES.—Nothing in this Act shall 
have the effect of superseding, negating, or limiting 
provisions of Federal law, including the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.) or the Public Health Service Act (42 U.S.C. 
201 et seq.), and regulations promulgated under 
such statutes, with respect to the regulation of 
drugs, devices, biological products, human cells, tis-
sues, or cellular or tissue-based products used in fer-
tility treatment. 
(4) PRESERVATION OF HIPAA RULES.—Nothing 
in this Act shall have the effect of superseding, ne-
gating, or limiting the provisions of the privacy, se-
curity, and breach notification regulations in parts 
160 and 164 of title 45, Code of Federal Regula-
tions (or successor regulations). 
(5) SUBSEQUENTLY ENACTED FEDERAL LEGIS-
LATION.—Federal statutory law adopted after the 
date of the enactment of this Act is subject to this 
Act unless such law explicitly excludes such applica-
tion by reference to this Act. 
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(b) DEFENSE.—In any cause of action against an in-
dividual or entity who is subject to a limitation or require-
ment that violates this Act, in addition to the remedies 
specified in section 4(c), this Act shall also apply to, and 
may be raised as a defense by, such an individual or entity. 
Æ 
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