,,ii #aaith ,,congress #ast ,session ,s4 #bjce ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #aa1 #bjbe,ms4 ,duckworth 7for herself1 ,mrs4 ,murray1 ,mr4 ,booker1 ,mr4 ,schumer1 ,mr4 ,reed1 ,ms4 ,warren1 ,mr4 ,padilla1 ,mr4 ,welch1 ,ms4 ,cantwell1 ,mr4 ,fetterman1 ,mr4 ,hickenlooper1 ,mr4 ,merkley1 ,mr4 ,schatz1 ,mr4 ,warner1 ,ms4 ,klobuchar1 ,ms4 ,alsobrooks1 ,mr4 ,coons1 ,mr4 ,king1 ,mr4 ,blumenthal1 ,mr4 ,whitehouse1 ,mr4 ,sanders1 ,mr4 ,peters1 ,mr4 ,gallego1 ,mr4 ,durbin1 ,mr4 ,heinrich1 ,ms4 ,hirono1 ,mrs4 ,shaheen1 ,ms4 ,rosen1 ,mr4 ,murphy1 and ,mrs4 ,gillibrand7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to establish statutory rights to choose to receive1 provide1 and cover fertility treatments1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,protect ,,ivf ,act4 #b4 ,purposes ,the purposes of this ,act are as follows3 7#a7 ,to permit patients to seek and receive fertility treatment1 including assisted reproductive technology services1 and to permit health care providers that choose to provide fertility treatment1 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 care1 and which do not significantly advance reproductive health or the efficacy and safety of fertility treatment1 or make fertility treatment more difficult to access4 7#b7 ,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 services4 7#c7 ,to protect an individual's right to make decisions1 in consultation with the individual's health care provider1 about the most appropriate medical care to maximize the chance of becoming pregnant and giving birth to a healthy1 living1 human child with the help of fertility treatment4 #c4 ,definitions ,in this ,act3 7#a7 ,fertility treatment ,the term fertility treatment includes the following3 7,a7 ,preservation of human oocytes1 sperm1 or embryos4 7,b7 ,artificial insemination1 including intravaginal insemination1 intracervical insemination1 and intrauterine insemination4 7,c7 ,assisted reproductive technology1 including in vitro fertilization and other treatments or procedures in which reproductive genetic material1 such as oocytes1 sperm1 and embryos1 are handled1 when clinically appropriate4 7,d7 ,genetic testing of embryos4 7,e7 ,medications prescribed or obtained over-the-counter1 as indicated for fertility4 7,f7 ,gamete donation4 7,g7 ,such other information1 referrals1 treatments1 procedures1 medications1 laboratory testing1 technologies1 and services relating to fertility as the ,secretary of ,health and ,human ,services determines appropriate4 7#b7 ,health care provider ,the term health care provider means any entity or individual 7including any physician1 nurse practitioner1 physician assistant1 pharmacist1 health care support personnel1 clinical staff1 and any other individual1 as determined by the ,secretary of ,health and ,human ,services7 that-- 7,a7 is engaged or seeks to engage in the delivery of fertility treatment1 including through the provision of evidence-based information1 counseling1 referrals1 or items and services that relate to1 aid in1 or provide fertility treatment2 and 7,b7 if required by ,state law to be licensed1 certified1 or otherwise authorized to engage in the delivery of such services-- 7i7 is so licensed1 certified1 or otherwise authorized2 or 7ii7 would be so licensed1 certified1 or otherwise authorized but for the fact that the individual or entity has provided1 is providing1 or plans to provide fertility treatment in accordance with section #d4 7#c7 ,health insurance issuer ,the term health insurance issuer has the meaning given such term in section #bgia7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia7;b774 7#d7 ,manufacturer ,the term manufacturer means the manufacturer of a drug or device approved1 cleared1 authorized1 or licensed under section #eje1 #eaj7k71 #eac7;f77#b71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj;c7f77#b71 #cfj;e7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 or otherwise legally marketed4 7#e7 ,state ,the term ,state includes each of the #ej ,states1 the ,district of ,columbia1 ,puerto ,rico1 each territory and possession of the ,united ,states1 and any political subdivision thereof4 7#f7 ,widely accepted and evidence-based medical standards of care ,the term widely accepted and evidence-based medical standards of care means any medical services1 procedures1 and practices that are in accordance with the guidelines of the ,american ,society for ,reproductive ,medicine4 #d4 ,fertility treatment rights 7a7 ,general rule 7#a7 ,individual rights ,an individual has a statutory right under this ,act1 without prohibition1 limitation1 interference1 or impediment1 to the extent that such prohibition1 limitation1 interference1 or impediment in any way or degree obstructs1 delays1 or affects commerce over which the ,federal ,government has jurisdiction1 to-- 7,a7 receive fertility treatment from a health care provider1 in accordance with widely accepted and evidence-based medical standards of care2 7,b7 continue or complete an ongoing fertility treatment previously initiated by a health care provider1 in accordance with widely accepted and evidence-based medical standards of care2 7,c7 make decisions and arrangements regarding the donation1 testing1 use1 storage1 or disposition of their own reproductive genetic material2 and 7,d7 establish contractual agreements with a health care provider relating to the health care provider's services in handling1 testing1 storing1 shipping1 and disposing of the individual's reproductive genetic material in accordance with widely accepted and evidence-based medical standards of care4 7#b7 ,health care provider rights ,a health care provider has a statutory right under this ,act1 without prohibition1 limitation1 interference1 or impediment1 to the extent that such prohibition1 limitation1 interference1 or impediment in any way or degree obstructs1 delays1 or affects commerce over which the ,federal ,government has jurisdiction1 to-- 7,a7 choose to provide1 or assist with the provision of1 fertility treatment provided in accordance with widely accepted and evidence-based medical standards of care2 7,b7 continue or complete the provision of1 or assistance with1 fertility treatment that was lawful when commenced and is provided in accordance with widely accepted and evidence-based medical standards of care2 7,c7 provide for1 or assist with1 the testing1 use1 storage1 or disposition of reproductive genetic material in accordance with widely accepted and evidence-based medical standards of care2 and 7,d7 establish contractual agreements with individuals or manufacturers relating to the health care provider's services in handling1 testing1 storing1 shipping1 and disposing of the individual's reproductive genetic material4 7#c7 ,health insurance issuer rights ,a health insurance issuer has a statutory right under this ,act1 without prohibition1 limitation1 interference1 or impediment1 to the extent that such prohibition1 limitation1 interference1 or impediment in any way or degree obstructs1 delays1 or affects commerce over which the ,federal ,government has jurisdiction1 to choose to cover the provision of fertility treatment provided in accordance with widely accepted and evidence-based medical standards of care4 7#d7 ,manufacturer rights ,a manufacturer of a drug or device that is approved1 cleared1 authorized1 or licensed under section #eje1 #eaj7k71 #eac7;f77#b71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee2 #cfj7k72 #cfj;c7f77#b72 #cfj;e7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 or otherwise legally marketed and intended for use in the provision of fertility treatment1 including the storage or transport of reproductive genetic material1 has a statutory right under this ,act1 without prohibition1 limitation1 interference1 or impediment1 to the extent that such prohibition1 limitation1 interference1 or impediment in any way or degree obstructs1 delays1 or affects commerce over which the ,federal ,government has jurisdiction1 to manufacture1 import1 market1 sell1 and distribute such drug or device4 7b7 ,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 7a7 if-- 7#a7 such regulations are in accordance with widely accepted and evidence-based medical standards of care for providing fertility treatment2 and 7#b7 the safety or health objective cannot be advanced by a different means that does not prohibit1 limit1 interfere with1 or impede the rights described in subsection 7a74 7c7 ,enforcement 7#a7 ,the ,attorney ,general 7,a7 ,in general ,the ,attorney ,general may commence a civil action on behalf of the ,united ,states against any ,state2 an individual1 employee1 official1 agency head1 contractor1 organization1 or instrumentality acting for1 or on behalf of1 such a ,state2 or any individual acting under the color of1 or pursuant to1 ,state law1 that implements1 enforces1 or threatens to enforce a limitation or requirement that prohibits1 limits1 interferes with1 or impedes the statutory rights of an individual1 a health care provider1 a health insurance issuer1 or a manufacturer under subsection 7a74 7,b7 ,effect of violations ,the court shall hold unlawful and set aside a limitation or requirement described in subparagraph 7,a7 if it is in violation of subsection 7a74 7#b7 ,private right of action 7,a7 ,in general ,any individual or entity adversely affected by an alleged violation of subsection 7a7 may commence a civil action against an individual1 employee1 official1 agency head1 contractor1 organization1 or instrumentality acting for1 or on behalf of1 such a ,state that enacts1 implements1 or enforces a limitation or requirement that prohibits1 limits1 interferes with1 or impedes the statutory rights of an individual1 a health care provider1 a health insurance issuer1 or a manufacturer under subsection 7a74 7,b7 ,effect of violations ,the court shall hold unlawful and enjoin a limitation or requirement described in subparagraph 7,a7 if it is in violation of subsection 7a74 7#c7 ,health care provider 7,a7 ,in general ,a health care provider may commence a civil action for relief on such provider's own behalf1 on behalf of the provider's staff1 or on behalf of the provider's patients who are or may be adversely affected by an alleged violation of subsection 7a74 7,b7 ,effect of violations ,the court shall hold unlawful and enjoin a limitation or requirement described in subparagraph 7,a7 if it is in violation of subsection 7a74 7#d7 ,equitable relief ,in any action under this section1 the court may award appropriate equitable relief1 including temporary1 preliminary1 or permanent injunctive relief4 7#e7 ,costs 7,a7 ,in general ,in any action under this section1 the court shall award costs of litigation1 as well as reasonable attorney's fees1 to any prevailing plaintiff4 7,b7 ,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 process4 7#f7 ,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 law4 7#g7 ,right to remove 7,a7 ,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 pending4 7,b7 ,review ,an order remanding the case to the ,state court from which it was removed under this paragraph is immediately reviewable by appeal or otherwise4 7d7 ,rules of construction 7#a7 ,in general ,for purposes of this ,act1 a ,state law1 or the administration1 implementation1 or enforcement of a ,state law1 constitutes a prohibition1 limitation1 interference1 or impediment on a health care provider choosing to provide1 an individual choosing to receive1 a health insurance issuer choosing to cover1 or a manufacturer choosing to market drugs or devices for fertility treatment1 provided in accordance with widely accepted and evidence-based medical standards of care1 as described in section #d1 if the administration1 implementation1 interpretation1 or enforcement of such law has an effect that-- 7,a7 imposes requirements or limitations that are inconsistent with providing1 receiving1 providing health insurance coverage for1 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 ,act1 which may include-- 7i7 requiring that a health care provider provide1 and patients undertake1 medically unnecessary procedures and services1 including tests and procedures1 providing medically inaccurate information regarding fertility treatment1 or requiring additional unnecessary in-person visits to a health care provider1 that are inconsistent with widely accepted and evidence-based medical standards of care2 7ii7 imposing limitations or requirements concerning physical offices1 clinics1 facilities1 equipment1 staffing1 or hospital transfer arrangements of facilities where fertility treatment is provided1 or the credentials or hospital privileges or status of personnel at such facilities1 that are not consistent with widely accepted and evidence-based medical standards of care2 or 7iii7 limiting a health care provider's right or ability to choose to provide1 or a patient's right to choose to receive1 or imposing limitations that reduce the efficacy of1 fertility treatment in accordance with widely accepted and evidence-based medical standards of care1 including retrieval of multiple eggs during oocyte retrieval2 performance of insemination procedures1 including intrauterine insemination2 intracytoplasmic sperm injections to fertilize multiple human eggs2 and cryopreservation of one or more eggs or embryos for fertility preservation1 if determined appropriate by the health care provider and patient2 7,b7 infringes1 limits1 or restricts the ability of a health care provider1 patient1 health insurance issuer1 or manufacturer1 to exercise or enforce their statutory rights under this ,act on the basis of marital status1 sex 7including sexual orientation and gender identity7 or any other protected class that is covered by ,federal law2 7,c7 limits a health care provider's or patient's right or ability to determine the most appropriate disposition of reproductive genetic materials1 including by defining reproductive genetic materials in such a way as to prevent or restrict options for the health care provider or patient2 7,d7 limits a health care provider's ability to provide1 or a patient's ability to receive1 fertility treatment via telemedicine1 in accordance with widely accepted and evidence-based medical standards of care2 7,e7 limits or prohibits a health care provider's ability to provide1 or a patient's ability to receive1 fertility counseling or fertility treatment based on the residency of the patient1 or prohibits or limits the ability of any individual to assist or support a patient seeking fertility treatment2 7,f7 imposes requirements or limitations that compel health care providers to provide1 or patients to receive1 medically unnecessary care1 or withhold medically necessary care1 in a manner that is not consistent with widely accepted and evidence-based medical standards of care for fertility treatment1 including mandating the transfer of embryos that a health care provider would not reasonably expect1 based on widely accepted and evidence-based medical standards of care1 to lead to a healthy pregnancy or a live birth2 7,g7 limits a health care provider's right or ability to prescribe or dispense1 or a patient's right or ability to receive or use1 medications for fertility treatment in accordance with widely accepted and evidence-based medical standards of care1 unless such a limitation is generally applicable to the prescription1 dispensing1 or distribution of medications2 or 7,h7 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 care4 7#b7 ,clarification ,the descriptions of specific ,state laws that would violate the statutory rights and protections described in paragraph 7#a7 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 7#a71 and potential violations of this ,act may result from novel ,state restrictions and limitations that are not listed under paragraph 7#a74 7#c7 ,exclusion ,it shall not constitute a prohibition1 limitation1 interference1 or impediment to a health care provider providing1 an individual receiving1 a health insurance issuer covering1 or a manufacturer marketing a drug or device for purposes of1 fertility treatment under this ,act for an entity to act in compliance with the ,food and ,drug ,administration's regulation of drugs1 devices1 biological products1 human cells1 tissues1 or cellular or tissue-based products used in fertility treatment1 consistent with widely accepted and evidence-based medical standards of care for fertility treatment4 #e4 ,applicability and preemption 7a7 ,in general 7#a7 ,general application 7,a7 ,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 law1 whether statutory1 common law1 or otherwise1 and whether adopted before or after the date of enactment of this ,act4 7,b7 ,prohibition ,no ,state shall administer1 implement1 or enforce any law1 rule1 regulation1 standard1 or other provision having the force and effect of law that conflicts with any provision of this ,act1 notwithstanding any other provision of ,federal law4 7#b7 ,exclusion ,preemption of ,state law under paragraph 7#a7 does not apply to-- 7,a7 ,state law regarding the resolution of disputes between #b individuals with rights described in section #d7;a77#a7 with respect to the same reproductive genetic material2 or 7,b7 any other ,state law1 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 care1 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 care4 7#c7 ,preservation of ,federal public health authorities ,nothing in this ,act shall have the effect of superseding1 negating1 or limiting provisions of ,federal law1 including the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 or the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq471 and regulations promulgated under such statutes1 with respect to the regulation of drugs1 devices1 biological products1 human cells1 tissues1 or cellular or tissue-based products used in fertility treatment4 7#d7 ,preservation of ,,hipaa rules ,nothing in this ,act shall have the effect of superseding1 negating1 or limiting the provisions of the privacy1 security1 and breach notification regulations in parts #afj and #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7#e7 ,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 ,act4 7b7 ,defense ,in any cause of action against an individual or entity who is subject to a limitation or requirement that violates this ,act1 in addition to the remedies specified in section #d7;c71 this ,act shall also apply to1 and may be raised as a defense by1 such an individual or entity4