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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H. Res. 1346 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
H. RES. 1346

  Providing for consideration of the bill (H.R. 7056) to prohibit the 
   limitation of access to assisted reproductive technology, and all 
               medical care surrounding such technology.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              July 9, 2024

Ms. Wild submitted the following resolution; which was referred to the 
                           Committee on Rules

_______________________________________________________________________

                               RESOLUTION

 
  Providing for consideration of the bill (H.R. 7056) to prohibit the 
   limitation of access to assisted reproductive technology, and all 
               medical care surrounding such technology.

    Resolved, That immediately upon adoption of this resolution, the 
House shall proceed to the consideration in the House of the bill (H.R. 
7056) to prohibit the limitation of access to assisted reproductive 
technology, and all medical care surrounding such technology. All 
points of order against consideration of the bill are waived. The 
amendment specified in section 3 of this resolution shall be considered 
as adopted. The bill, as amended, shall be considered as read. All 
points of order against provisions in the bill, as amended, are waived. 
The previous question shall be considered as ordered on the bill, as 
amended, and on any further amendment thereto, to final passage without 
intervening motion except: (1) one hour of debate equally divided and 
controlled by the chair and ranking minority member of the Committee on 
Energy and Commerce or their respective designees; and (2) one motion 
to recommit.
    Sec. 2.  Clause 1(c) of rule XIX shall not apply to the 
consideration of H.R. 7056.
    Sec. 3.  The amendment specified in this section is as follows:
     Strike sections 2 through 5 and insert the following:

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 for later reproductive use.
                    (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, fertilized eggs, 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 
                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 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) 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, such as oocytes, sperm, fertilized eggs, and 
                embryos, 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 
        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 oocytes, gametes, fertilized eggs, and embryos, 
        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) 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 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 fertility 
        treatment, provided in accordance with widely accepted 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 providing drugs or 
                devices for fertility treatment in accordance with 
                widely accepted and evidence-based medical standards of 
                care or that otherwise violate the 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 provide, or a patient's 
                        right 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 and subsequent 
                        transfer, 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 fertilized eggs or embryos, including by 
                defining a gamete or embryo 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, 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, such as oocytes, 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 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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