119-s2035

[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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