[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2035 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 2035
To establish statutory rights to choose to receive, provide, and cover
fertility treatments, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 11, 2025
Ms. Duckworth (for herself, Mrs. Murray, Mr. Booker, Mr. Schumer, Mr.
Reed, Ms. Warren, Mr. Padilla, Mr. Welch, Ms. Cantwell, Mr. Fetterman,
Mr. Hickenlooper, Mr. Merkley, Mr. Schatz, Mr. Warner, Ms. Klobuchar,
Ms. Alsobrooks, Mr. Coons, Mr. King, Mr. Blumenthal, Mr. Whitehouse,
Mr. Sanders, Mr. Peters, Mr. Gallego, Mr. Durbin, Mr. Heinrich, Ms.
Hirono, Mrs. Shaheen, Ms. Rosen, Mr. Murphy, and Mrs. Gillibrand)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To establish statutory rights to choose to receive, provide, and cover
fertility treatments, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Protect IVF Act''.
SEC. 2. PURPOSES.
The purposes of this Act are as follows:
(1) To permit patients to seek and receive fertility
treatment, including assisted reproductive technology services,
and to permit health care providers that choose to provide
fertility treatment, to provide such services without States
enacting harmful or unwarranted limitations or requirements
that single out the provision of assisted reproductive services
for restrictions that are not consistent with widely accepted
and evidence-based medical standards of care, and which do not
significantly advance reproductive health or the efficacy and
safety of fertility treatment, or make fertility treatment more
difficult to access.
(2) To promote the right and ability of a patient residing
in any State to choose to receive fertility treatment provided
in accordance with widely accepted and evidence-based medical
standards of care by a health care provider who chooses to
provide such services.
(3) To protect an individual's right to make decisions, in
consultation with the individual's health care provider, about
the most appropriate medical care to maximize the chance of
becoming pregnant and giving birth to a healthy, living, human
child with the help of fertility treatment.
SEC. 3. DEFINITIONS.
In this Act:
(1) Fertility treatment.--The term ``fertility treatment''
includes the following:
(A) Preservation of human oocytes, sperm, or
embryos.
(B) Artificial insemination, including intravaginal
insemination, intracervical insemination, and
intrauterine insemination.
(C) Assisted reproductive technology, including in
vitro fertilization and other treatments or procedures
in which reproductive genetic material, such as
oocytes, sperm, and embryos, are handled, when
clinically appropriate.
(D) Genetic testing of embryos.
(E) Medications prescribed or obtained over-the-
counter, as indicated for fertility.
(F) Gamete donation.
(G) Such other information, referrals, treatments,
procedures, medications, laboratory testing,
technologies, and services relating to fertility as the
Secretary of Health and Human Services determines
appropriate.
(2) Health care provider.--The term ``health care
provider'' means any entity or individual (including any
physician, nurse practitioner, physician assistant, pharmacist,
health care support personnel, clinical staff, and any other
individual, as determined by the Secretary of Health and Human
Services) that--
(A) is engaged or seeks to engage in the delivery
of fertility treatment, including through the provision
of evidence-based information, counseling, referrals,
or items and services that relate to, aid in, or
provide fertility treatment; and
(B) if required by State law to be licensed,
certified, or otherwise authorized to engage in the
delivery of such services--
(i) is so licensed, certified, or otherwise
authorized; or
(ii) would be so licensed, certified, or
otherwise authorized but for the fact that the
individual or entity has provided, is
providing, or plans to provide fertility
treatment in accordance with section 4.
(3) Health insurance issuer.--The term ``health insurance
issuer'' has the meaning given such term in section 2791(b) of
the Public Health Service Act (42 U.S.C. 300gg-91(b)).
(4) Manufacturer.--The term ``manufacturer'' means the
manufacturer of a drug or device 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.
(5) State.--The term ``State'' includes each of the 50
States, the District of Columbia, Puerto Rico, each territory
and possession of the United States, and any political
subdivision thereof.
(6) Widely accepted and evidence-based medical standards of
care.--The term ``widely accepted and evidence-based medical
standards of care'' means any medical services, procedures, and
practices that are in accordance with the guidelines of the
American Society for Reproductive Medicine.
SEC. 4. 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.
SEC. 5. APPLICABILITY AND PREEMPTION.
(a) In General.--
(1) General application.--
(A) Effect on state law.--This Act supersedes any
State law that is inconsistent with the statutory
rights established under this Act and precludes the
implementation of such a law, whether statutory, common
law, or otherwise, and whether adopted before or after
the date of enactment of this Act.
(B) Prohibition.--No State shall administer,
implement, or enforce any law, rule, regulation,
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 described in section
4(a)(1) with respect to the same reproductive genetic
material; 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 receive 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 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, tissues, or cellular or tissue-based products used in
fertility treatment.
(4) Preservation of hipaa rules.--Nothing in this Act shall
have the effect of superseding, negating, or limiting the
provisions of the privacy, security, and breach notification
regulations in parts 160 and 164 of title 45, Code of Federal
Regulations (or successor regulations).
(5) Subsequently enacted federal legislation.--Federal
statutory law adopted after the date of the enactment of this
Act is subject to this Act unless such law explicitly excludes
such application by reference to this Act.
(b) Defense.--In any cause of action against an individual or
entity who is subject to a limitation or requirement 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.
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