ACP’s Advocacy in the Courts

Amy Bryan, M.D., v. Timothy K. Moore, et al, and Joshua H. Stein, in his official capacity as Attorney General for the state of North Carolina, et al. (Filed: 10/17/2024)
In May 2023, the North Carolina state legislature passed Senate Bill 20, imposing new restrictions to obtaining abortion care in the state. The governor vetoed the bill, but both houses voted to override the veto, and the law went into effect. The law prohibits abortions after 12 weeks with limited exceptions, creates a more stringent waiting period, and imposes new reporting requirements on physicians performing abortions. The law also creates a waiting period for medication abortion, and it may only be administered in-person following an in-person examination. A U.S. District Judge issued a permanent injunction prohibiting the state from enforcing the in-person prescribing and administration requirement, the requirement for physicians to prescribe the drug, and the requirement for an in-person follow up appointment, finding that these state laws are preempted by federal law. The district judge did leave in place the state law requiring an in-person consultation and 72-hour waiting period, finding that FDA regulation of mifepristone did not address these components of the law. All parties appealed this ruling to the U.S. Court of Appeals for the Fourth Circuit, which is where this brief will be filed on behalf of Dr. Bryant and preserving access to medication abortion.

ACP has extensive policy on access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In this amicus brief, the interested parties argue that Mifepristone has been thoroughly studied and is conclusively safe, and the FDA has already concluded that there is no scientific basis for any of North Carolina’s regulations.

See additional relevant ACP advocacy in the Access to Care section.

State of Idaho v. United States of America (Filed: 3/28/2024)
In March 2020, the governor of Idaho signed into law a trigger bill that would institute a near-total ban on abortion in the state. Prior to the provisions of the law going into effect with the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, HHS released guidance clarifying the responsibility of hospitals and medical professionals under the Emergency Medical Treatment and Labor Act (EMTALA). EMTALA requires health professionals to provide abortion services if it is required to stabilize the patient’s condition, regardless of any underlying state law. The U.S. filed a lawsuit against Idaho alleging that the state law conflicted with federal law under EMTALA, and a preliminary injunction was issued blocking the Idaho law from going into effect. This brief will be filed in the Supreme Court on behalf of the U.S. and protecting access to necessary health care services.

ACP has extensive policy on access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In this amicus brief, the interested parties argue that the Idaho law criminalizes care required under EMTALA, as pregnant patients can require stabilizing care in emergency medical situations. They further argue that pregnant people are experiencing negative consequences as a result of the Idaho law, which disproportionately harms rural and poor pregnant people and pregnant people of color.

United States of America v. State of Idaho and Mike Moyle, Speaker of the Idaho House of Representatives; Chuck Winder, President Pro Tempore of the Idaho Senate; The Sixty-Seventh Idaho Legislature (Filed: 10/22/2024)
In June 2024, the Supreme Court of the U.S. dismissed this case, finding the decision to hear the case was improvidently granted. The Supreme Court also vacated its stay of the district court’s preliminary injunction, allowing pregnant people in Idaho to continue to obtain emergency abortion care as the case continues to be litigated. Because the Supreme Court did not rule on the facts of the case, the case was sent down to the U.S. Court of Appeals for the Ninth Circuit to be litigated, which is where this brief was filed.

See additional relevant ACP advocacy in the Access to Care section.

State of Texas, et al., v. Amanda Zuraski, et al. (Filed: 11/21/2023)
This case involves various Texas laws restricting abortion, including S.B. 8, which bans abortions after the fetal heartbeat is detectible, and H.B. 1280, which makes it illegal to perform an abortion after the point of conception. In March 2023, a lawsuit was filed seeking the state of Texas to clarify the scope of the “medical emergency” exceptions under the various abortion laws and to request a temporary injunction blocking the bans for pregnancy complications while the case was being heard. A District Court judge issued a temporary injunction order blocking the bans as they pertain to pregnancy complications and found S.B. 8 to be unconstitutional. The Texas Attorney General appealed the decision directly to the Texas Supreme Court, which is where this brief will be filed.

ACP has extensive policy on access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In this amicus brief, the interested parties argue that the laws prevent patients from obtaining necessary care and force clinicians to make an impossible choice between upholding their ethical obligations and following the law. They further argue that the bans undermine the physician-patient relationship and will diminish the availability of OB-GYN care for all Texans, disproportionately impacting people of color, people living in rural areas, and people with low incomes.

See additional relevant ACP advocacy in the Access to Care section.

Alliance for Hippocratic Medicine, et al. v. Food and Drug Administration, et al.; Danco Laboratories, LLC (Filed: 4/11/2023)
This case involves mifepristone, one of two drugs currently used in the typical regiment for chemically inducing an abortion. In late 2022, a group of anti-abortion medical groups filed a lawsuit challenging the FDA’s original approval of mifepristone in 2000, alleging that the FDA gave in to political pressure and did not appropriately assess the safety of the drug in granting its approval. This brief will be filed on behalf of the FDA and the manufacturer of mifepristone in an appeal of a Texas judge’s ruling to suspend FDA approval of the drug.

ACP has extensive policy on access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In particular, ACP policy opposes restrictions to one’s right to access abortion services, including medication abortion. In this amicus brief, the interested parties argue that providers affirm the safety and effectiveness of mifepristone, that mifepristone is a standard treatment not only for abortion, but also for early pregnancy loss, and that the availability of mifepristone is essential to protect patient autonomy.

See additional relevant ACP advocacy in the Access to Care section.

Danco Laboratories, LLC., v. Alliance for Hippocratic Medicine, et al. and Food and Drug Administration, et al., v. Alliance for Hippocratic Medicine, et al. (Filed: 4/14/2023)
After a Texas judge issued a preliminary injunction to suspend FDA approval of Mifepristone, the drug’s manufacturer and the FDA applied for emergency relief in the Supreme Court to stay the injunction to suspend approval as the case moves through the courts. This brief was filed in the Supreme Court on behalf of the FDA and the manufacturer of mifepristone to stay the injunction to suspend FDA approval of the drug.

Planned Parenthood South Atlantic v. South Carolina (Filed: 9/16/2022)
This case challenges a South Carolina state law that prohibits an abortion after a fetal heartbeat is detected, with limited exceptions. ACP has extensive policy on women’s access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In this amicus brief, the interested parties argue that abortion is a safe, common, and essential component of health care and that the state’s prohibitions are lacking medical and scientific justification.

Further, this ban will harm pregnant patients’ health and well-being and would particularly negatively impact racial and ethnic minorities, rural, and low-income pregnant people. Additionally, the law would interfere in the patient-physician relationship by making medical professionals choose between violating the law or violating biomedical ethical principles of beneficence, non-maleficence, and autonomy.

See additional relevant ACP advocacy in the Access to Care section.

Planned Parenthood of Montana v. Montana (Filed: 3/28/2022)
This case challenges three different Montana state laws, including: 1) a prohibition on abortions after 20 weeks gestational age, with limited exceptions; 2) a requirement that medical professionals offer individuals obtaining an abortion to view ultrasound images and listen to fetal heartbeats prior to the abortion; and 3) a requirement that abortion inducing drugs be distributed by a qualified medical practitioner, with certain requirements and measures that the qualified medical practitioner must take in distributing the medication. Violations of these laws would be subject to criminal and/or civil penalties.

ACP has extensive policy on women’s access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In this amicus brief, the interested parties argue that the state’s alleged interests are unsupported by medical evidence, the restrictions undermine the patient-physician relationship, and that the restrictions impede access to reproductive health care services and disproportionately impact marginalized pregnant people.

Planned Parenthood of Montana and Samuel Dickman, M.D., v. State of Montana (Filed: 8/14/2024)
In August 2022, the Montana Supreme Court upheld a district court’s preliminary injunction blocking the three abortion restriction laws from going into effect. In February 2024, a district court in Montana granted summary judgement for Planned Parenthood of Montana and permanently enjoined the three laws from being implemented. The state appealed this decision to the Montana Supreme Court, which is where this updated brief will be filed on behalf of Planned Parenthood of Montana and protecting access to reproductive health care services.

In this amicus brief, the interested parties argue that the abortion restriction laws have no medical justification and would disproportionately affect patients living in rural areas and those with fewer resources. They further argue that the laws would undermine physicians’ ability to perform their jobs and violate the principles of beneficence and respect for patient autonomy.

See additional relevant ACP advocacy in the Access to Care section.

Dobbs v. Jackson Women’s Health Organization (Filed: 9/20/2021)
This case challenges a 2018 Mississippi law that bans abortions beyond 15 weeks from gestation with limited exceptions for cases of medical emergency. Physicians violating this law would be subject to professional penalties, including revocation of their medical license. A U.S. District court struck down the law in 2018, and this decision was upheld by the U.S. Fifth Circuit Court of Appeals. In May 2021, the U.S. Supreme Court granted the state of Mississippi’s cert petition and this amicus brief was filed on behalf of the plaintiffs, a Mississippi physician and clinic that provide abortion services.

ACP has extensive policy on women’s access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In this amicus brief, the interested parties argue that abortion is a safe and essential component of health care and that scientific evidence conclusively demonstrates that a fetus is not viable at fifteen weeks. Furthermore, it is argued that this law could have harmful impacts on pregnant patients’ physical and psychological health and would force physicians to make an impossible choice between upholding their ethical obligations and adhering to state law.

See additional relevant ACP advocacy in the Access to Care section.

Isaacson, et al., v. Brnovich, et al. (Filed: 12/27/2021)
This case challenges a 2021 Arizona law revising existing state statutes which would prohibit physicians from performing an abortion if they know that the mother’s reason for seeking is due to a non-lethal genetic abnormality of the fetus and redefine personhood to extend legal protections to a fetus regardless of gestational age, embryos, and fertilized eggs. The law was challenged and a district judge issued a partial preliminary injunction but allowed the personhood aspect of the law to remain intact as the case proceeds through the legal process.

This injunction was challenged by the state of Arizona and this brief was filed in the appeals court. ACP has extensive policy on women’s access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In this amicus brief, the interested parties argue that the law would criminalize routine medical procedures, limit access to necessary care, and infringe upon the integrity of the medical profession.

See additional relevant ACP advocacy in the Access to Care section.

Planned Parenthood South Atlantic, et al., v. Wilson, McMaster, Cook, et al. (Filed: 9/8/2021)
This case challenges a 2021 South Carolina law banning abortions after a fetal heartbeat is detectible and audible, typically around six weeks, with limited exceptions for medical emergencies. This brief was filed on behalf of plaintiffs in an appeal against a preliminary injunction preventing the implementation of the law.

ACP has extensive policy on women’s access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In this amicus brief, the interested parties argue that the law has no evidence-based health justification, will endanger women’s physical and psychological health, and will place physicians in an ethically compromised position.

See additional relevant ACP advocacy in the Access to Care section.

Planned Parenthood South Atlantic and Julie Edwards v. Thomas Clark Phillip, JR (Filed: 6/4/2021)
This case challenges a 2018 South Carolina executive order directing the Department of Health and Human Services to “deem abortion clinics…and any affiliated physicians or professional medical practices…enrolled in the Medicaid program as unqualified to provide family planning services. In 2020, a U.S. District judge issued a ruling which permanently enjoined the state’s restrictions, and this brief was filed on behalf of plaintiffs against South Carolina’s appeal of this ruling.

ACP has extensive policy on funding for women’s health clinics and women’s access to reproductive health care and family planning services. In this amicus brief, the interested parties argue that Medicaid and Planned Parenthood are integral to providing health care in South Carolina, the state has provided no medical reason for excluding Planned Parenthood from the state’s Medicaid program, and that this exclusion would be detrimental to public health in South Carolina.

See additional relevant ACP advocacy in the Access to Care section.

Planned Parenthood Minnesota, North Dakota, South Dakota, et al., v. Kristi Noem, Alpha Center, et al. (Filed: 3/24/2022)
This case involves a 2011 South Dakota law instituting a 72-hour waiting period for individuals seeking an abortion beginning after a required in-person consultation. The law additionally required physicians to determine whether the individual was seeking an abortion out of coercion and to provide information to state-registered pregnancy help centers. While the 72-hour waiting period became law, the consultation requirement was enjoined by a temporary injunction. This brief was filed in a 2021 appeal of a ruling sustaining the temporary injunction.

ACP has extensive policy on women’s access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In this amicus brief, the interested parties argue that the consultation and waiting period requirements violate principles of informed consent, intrude on the patient-physician relationship, and will cause serious harms to patients.

See additional relevant ACP advocacy in the Access to Care section.

SisterSong Women of Color Reproductive Justice Center, et al., v. Brian Kemp, et al. (Filed: 2/23/2021)
This case challenges a 2019 Georgia law which requires physicians to determine the presence of a heartbeat before performing an abortion procedure and prohibits the provision of an abortion if a heartbeat is detected, with exceptions for medically futile pregnancies and cases of incest or rape. The law also changes the state’s definition of a “natural person” to specifically include “any human being including an unborn child.”

This amicus brief was filed on behalf of plaintiffs, Georgia physicians and clinics providing abortion services, in a state appeal of a District Court ruling permanently blocking implementation of the law. ACP has extensive policy on women’s access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In this amicus brief, the interested parties argue that the state has unlawfully banned pre-viability abortion; and that the law would prohibit nearly all abortions in Georgia, endanger patients’ health, and impinge upon the integrity of the medical profession.

See additional relevant ACP advocacy in the Access to Care section.

The United States of America v. Texas, et al. (Filed: 10/11/21)
This case challenges a 2021 Texas law banning abortions after a fetal heartbeat is detected with exceptions only for medical emergencies that endanger the pregnant person’s life. This law creates a private right of action that empowers private citizens, and not government officials, to sue any physician who provides a prohibited abortion, without having any connection to those involved with the abortion procedure.

It also goes beyond other similar bills in that individuals who assist one in obtaining a prohibited abortion are assigned liability as well. This brief was filed on behalf of plaintiffs in an appeal by Texas against a district judge’s preliminary injunction blocking enforcement of the law. ACP has extensive policy on women’s access to reproductive health care and family planning services and opposing interference in the patient-physician relationship. In this amicus brief, the interested parties argue that the bill harms pregnant patients’ health by effectively banning abortion services and violates bedrock principles of medical ethics including respect for patient autonomy and beneficence and non-maleficence.

See additional relevant ACP advocacy in the Access to Care section.

State of Texas; State of Montana, v. Xavier Becerra, Secretary, U.S. Department of Health and Human Services; Melanie Fontes Rainer, Director, Centers for Medicare and Medicaid Services; United States Department of Health and Human Services (Filed: 12/04/2024)
Under Section 1557 of the ACA, health programs or activities that receive federal funding are prohibited from discriminating on the basis of race, color, national origin, sex, age, or disability. In 2016, HHS issued a final rule implementing Section 1557 that interpreted discrimination on the basis of sex as encompassing sex stereotyping, gender expression, gender identity, and termination of pregnancy. The first Trump administration reversed the 2016 rule’s expanded definition of sex discrimination, and then the Biden administration once again expanded the definition. In 2024, Texas and Montana filed a lawsuit arguing that enforcing the Section 1557 antidiscrimination protections related to gender-affirming care would require them to cover such services under their state’s Medicaid programs despite their state law prohibiting it. A district judge postponed the effective date of the Biden Administration’s final rule in Texas and Montana as the case proceeds through the courts. The federal government appealed this ruling, and this brief will be filed on their behalf in support of expanded anti-discrimination protections and access to gender-affirming care.

ACP has extensive policy on supporting antidiscrimination efforts in health care settings, supporting access to LGBTQ+-inclusive and gender-affirming care, and ensuring access to care for all individuals, regardless of personal characteristics. ACP has submitted comments in support of the exact Section 1557 rule that is currently being challenged. In this amicus brief, the interested parties argue that LGBTQ people with chronic diseases face distinct challenges accessing health care. They further argue that discrimination in health care harms many LGBTQ people in many different ways, and preventing discrimination is integral to improving health outcomes and providing better preventive care.

See additional relevant ACP advocacy in the Access to Care section.

State of Tennessee, et al., v. Xavier Becerra, Secretary, U.S. Department of Health and Human Services; Melanie Fontes Rainer, in her official capacity as Director of the Office for Civil Rights; Chiquita Brooks-Lasure, in her official capacity as Administrator of the Centers for Medicare and Medicaid Services (Filed: 11/26/2024)
Under Section 1557 of the ACA, health programs or activities that receive federal funding are prohibited from discriminating on the basis of race, color, national origin, sex, age, or disability. In 2016, HHS issued a final rule implementing Section 1557 that interpreted discrimination on the basis of sex as encompassing sex stereotyping, gender expression, gender identity, and termination of pregnancy. The first Trump administration reversed the 2016 rule’s expanded definition of sex discrimination, and then the Biden administration once again expanded the definition. In 2024, Tennessee and fourteen other states filed a lawsuit against HHS and CMS administrators, arguing that enforcing the Section 1557 antidiscrimination protections around gender-affirming care would require them to cover such services under their state’s Medicaid programs. A district judge issued a preliminary injunction, preventing the federal government from extending sex discrimination to include discrimination on the basis of gender identity nationwide. The government appealed this ruling, and this brief was filed on their behalf in support of expanded anti-discrimination protections.

ACP has extensive policy on supporting antidiscrimination efforts in health care settings, supporting access to LGBTQ+-inclusive and gender-affirming care, and ensuring access to care for all individuals, regardless of personal characteristics. ACP has submitted comments in support of the exact Section 1557 rule that is currently being challenged. In this amicus brief, the interested parties argue that LGBTQ people with chronic diseases face distinct challenges accessing health care. They further argue that discrimination in health care harms many LGBTQ people in many different ways, and preventing discrimination is integral to improving health outcomes and providing better preventive care.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

Scarlet Van Garderen, et al., v. State of Montana, et al. (Filed: 4/11/2024)
This case involves a Montana law prohibiting the provision of gender-affirming surgery, hormone therapy, and puberty blockers to individuals under the age of 18. Medical professionals found to have violated this prohibition would face professional licensure penalties. The law was challenged, and a district judge issued a preliminary injunction preventing the law from going into effect. This case will be filed on behalf of the plaintiffs and access to gender-affirming care in a challenge of the preliminary injunction by Montana. ACP’s overall policy on lesbian, gay, bisexual, and transgender disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that a ban on this care would irreparably harm many adolescents by denying them the treatment they need.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

Jaime Masters; Texas Department of Family and Protective Services, v. PFLAG, Inc; Mirabel Voe and Antonio Voe, a minor; Wanda Roe and Tommy Roe, a minor; Adam Briggle and Amber Briggle and M.B., a minor (Filed: 1/24/2024)
Following the 2022 release of an official memo by the Texas attorney general finding that gender-affirming care provided to minors constituted child abuse, Texas governor Gregg Abbott issued a directive instructing the Texas Department of Family Protective Services to begin investigating instances of gender-affirming care provision to minors as child abuse. The agency complied with this order and at least nine investigations were opened into families who have permitted their transgender child to receive gender-affirming care. Several families with transgender children filed for a temporary injunction against the enforcement of this order and the district court granted the injunction for three families and PFLAG, therefore extending the injunction to all members of a PFLAG chapter. This brief will be filed on behalf of PFLAG and the families in an appeal of the injunction by the Texas Department of Family Protective Services. ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that enforcement of this order would irreparably harm many adolescents by denying them the treatment they need.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

Dylan Brandt, et al., v. Tim Griffin, et al. (Filed: 12/18/2023)
This case involves an Arkansas law prohibiting physicians from proving gender-affirming care to individuals under 18 and prohibits the state Medicaid program and private insurance from reimbursing gender-affirming care for minors. The Arkansas governor vetoed the legislation, but the state legislature voted to overturn the veto and the law went into effect. The law was challenged in district court and struck down, but this decision was appealed by Arkansas. ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that a ban on this care would irreparably harm many adolescents by denying them the treatment they need.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

Jane Doe 1, et al., v. Commonwealth of Kentucky ex rel. Daniel Cameron, Attorney General of the Commonwealth of Kentucky (Filed: 12/11/2023)
This case involves a Kentucky law under which physicians are prohibited from providing any form of gender-affirming care to transgender patients under the age of 18. Physicians who are found to have violated this prohibition face the revocation of their medical license, as well as be subject to civil damages. In addition to restrictions on gender-affirming care, the law also has provisions prohibiting the teaching or discussion of sexual orientation or gender identity for students of any age at schools and the use of bathrooms and other facilities that align with the gender identity of transgender students. ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that a ban on this care would irreparably harm many adolescents by denying them the treatment they need.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

T.D., et al., v. Drew H Wrigley, Attorney General for the State of North Dakota, et al. (Filed: 10/31/2023)
This case involves a North Dakota law prohibiting the provision of gender-affirming care for transgender adolescents in the state. Health professionals who violate the prohibition on gender-affirming surgery are guilty of a class B felony and subject to up to ten years in prison. This amicus brief was filed on behalf of three families who contend the law interferes with their ability to make health care decisions for their children, as well as a physician who cares for transgender adolescents. ACP’s overall policy on lesbian, gay, bisexual, and transgender disparities supports policies that benefit the overall health and well-being of LGBTQ+ populations. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that a ban on gender affirming care would irreparably harm many adolescents by denying them necessary medical treatment.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

K.C., et al., v. Individual Members of the Medical Licensing Board of Indiana (Filed 9/27/2023)
This case involves an Indiana law under which physicians are prohibited from providing, aiding, or abetting gender-affirming surgery, hormone replacement therapy, puberty blockers, and gender-affirming mental health care and social services support to transgender patients under the age of 18. The law also creates a private right to action that allows an adolescent or their parent to pursue civil charges against a health provider, with an exception for cases in which the parent consented to the care. As a result of an ACLU lawsuit, a district court judge issued a preliminary injunction blocking the state from implementing most of the provisions of the law. This brief was filed on behalf of the preliminary injunction in an appeal by the Indiana Medical Licensing Board of Indiana.

ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that a ban on gender affirming care would irreparably harm many adolescents by denying them necessary medical treatment.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

Lazaro Loe, et al., v. Texas, et al. (Filed: 8/11/2023)
This case involves a Texas law that prohibits physicians from providing gender-affirming surgery, hormone replacement therapy, and puberty blockers to transgender patients under the age of 18. The law also prohibits state Medicaid and CHIP programs from covering these services and prohibits the distribution of public funds to individuals or institutions that provide or facilitate the provision of prohibited gender-affirming care for adolescents. This amicus brief was filed on behalf of five families in Texas who contend the law interferes with their ability to make health care decisions for their children.

ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that Texas’ ban is based on factually inaccurate information and would irreparably harm many adolescents by denying them necessary medical treatment.

The State of Texas, et al. v. Lazaro Loe, et al. (Filed: 1/5/2024)
In August 2023, the Travis County District Court entered an order blocking the gender-affirming care ban from being implemented. The Texas Attorney General appealed that decision and the plaintiffs sought emergency relief from the Texas Supreme Court to reinstate the district court’s ruling and to stop the ban from going into effect. The Texas Supreme Court denied the plaintiffs’ request for emergency relief, which allowed the ban to take effect on September 1. While the request for emergency relief was denied, the Texas Supreme Court will continue to hear arguments in this case and this amicus brief was filed on behalf of the plaintiffs and protecting access to gender-affirming care in Texas.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

L.W., et al., v. Jonathan Skrmetti, et al. (Filed: 8/10/2023)
This case involves a Tennessee law banning gender affirming care for adolescents and implementing financial and licensure penalties for physicians who violate the law. The law was challenged on behalf of three families who contend that the law interferes with their ability to make health care decisions for their children, as well as a physician who cares for transgender adolescents. A preliminary injunction was issued blocking the state from enforcing its prohibition on hormone treatment, but on appeal, the district court’s preliminary injunction was stayed, allowing the law to go into effect as the case proceeds through the legal system. This brief was filed in support of a motion to appeal the stay.

ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that scientific evidence indicates the effectiveness of treating gender dysphoria according to these guidelines and that a ban on gender affirming care would irreparably harm many adolescents by denying them necessary medical treatment.

L.W., et al., v. Jonathan Skrmetti, et al. (Filed: 12/4/2023)
In September 2023, the U.S. Court of Appeals for the Sixth Circuit rejected the plaintiff’s request to block enforcement of the state’s restrictions on gender-affirming care. As such, the law prohibiting access to gender-affirming care for minors remains in effect. The plaintiffs filed a petition for a writ of certiorari with the Supreme Court of the United States, and this brief will be filed with the Supreme Court in support of the plaintiff’s request to hear this case.

United States of America v. Jonathan Skrmetti, et al. (Filed: 9/3/2024)
In June 2024, the Supreme Court granted certiorari and will be hearing arguments in this case. This brief will be filed on behalf of the U.S. and protecting access to medically appropriate gender-affirming care.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

Pam Poe, et al., v. Raúl Labrador, et al. (Filed: 7/25/2023)
This case challenges an Idaho law that amends state code regarding genital mutilation of a child to prohibit physicians from providing gender-affirming surgery, puberty blockers, and other hormone therapy to transgender patients under the age of 18. While a general exception has historically been provided to permit medical interventions necessary for the health of a patient, this law amends the exception to exclude gender-affirming treatment for gender dysphoria. Medical professionals who are found to have violated this prohibition would face criminal penalties, including a felony charge carrying up to ten years in prison and a fine of up to $5,000.

ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that the Idaho legislature makes factually inaccurate claims to support the ban, a ban which would irreparably harm many adolescents by denying them necessary medical treatment.

Pam Poe, et al., v. Raúl Labrador, et al. (Filed: 3/12/2024)
In December 2023, the district court issued an order enjoining Idaho from enforcing this law as the case proceeds through the court system and denied the state’s request to stay the preliminary injunction. In January 2024, Idaho appealed the district court’s decision to the U.S. Court of Appeals for the Ninth Circuit, which is where this brief will be filed on behalf of the plaintiffs and access to gender-affirming care.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

Emma Koe, et al., v. Caylee Noggle, et al. (Filed: 7/3/2023)
This case challenges a Georgia law that prohibits physicians from providing gender-affirming surgery and hormone replacement therapy to transgender patients under the age of 18. Medical professionals who are found to have violated this prohibition face unspecified licensure penalties. ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations and calls on public and private payers to cover comprehensive transgender health services. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that Georgia’s legislative findings are factually inaccurate, and a ban on this care would irreparably harm many adolescents by denying them necessary medical treatment.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

Peter Poe, et al., v. Gentner Drummond, et al. (Filed: 6/9/2023)
This case challenges an Oklahoma law that prohibits physicians from providing gender-affirming surgery and hormone therapy to transgender patients under the age of 18. Medical professionals who are found to have violated this prohibition face the revocation of their medical license, as well as be subject to civil suits that could be brought by parents, guardians, and next friend of the impacted adolescent up until age 45.

ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations and calls on public and private payers to cover comprehensive transgender health services. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that a ban on this care would irreparably harm many adolescents by denying them necessary medical treatment.

Peter Poe, et al., v. Gentner Drummond, et al. (Filed: 11/16/2023)
In October 2023, a district court judge denied the plaintiffs’ motion for a preliminary injunction blocking implementation of the law which allowed the ban on gender-affirming surgery and hormone therapy to go into effect immediately. This brief was filed in support of the plaintiffs’ appeal of the district court’s decision.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

Jane Doe, et al., v. Joseph A. Ladapo, et al. (Filed: 4/24/23)
This case challenges a November 2022 Florida Board of Medicine decision to adopt new standards of care that prohibit the provision of gender-affirming care—including puberty blockers, hormone therapy, and surgery—to transgender adolescents. ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations and calls on public and private payers to cover comprehensive transgender health services.

In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. Further, the parties argue that the material supporting the Board’s healthcare ban is factually inaccurate and ignores the recommendations of the medical community.

Jane Doe, et al., v. Surgeon General, State of Florida, et al. (Filed: 10/13/2023)
On June 6, 2023, District Judge Robert Hinkle issued a preliminary injunction preventing the state from enforcing its ban on gender-affirming care while the case moves through the courts. The state of Florida appealed the preliminary injunction order to the U.S. Court of Appeals for the 11th Circuit, which is where this updated brief was filed in support of affirming the preliminary injunction.

Jane Doe, et al., v. Surgeon General, State of Florida, et al. (Filed: 10/9/2024)
On August 26, 2024, the U.S. Court of Appeals for the 11th Circuit ruled 2-1 to grant the state’s request for a stay of the injunction pending appeal. This decision means that the lower district court’s injunction blocking enforcement of the ban on gender affirming care is overturned as the case proceeds through the courts. This brief will be filed in support of the plaintiff's challenge of the state’s policies at the merit stage with the U.S. Court of Appeals for the 11th Circuit.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

August Dekker, et al., v. Jason Weida, et al. (Filed: 4/28/23)
This case challenges a rule finalized by the Florida Agency for Health Care Administration (AHCA), the state agency that administers Florida’s Medicaid program, that prohibits the coverage of certain types of gender-affirming care for transgender Medicaid beneficiaries. ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations and calls on public and private payers to cover comprehensive transgender health services.

In this amicus brief, the interested parties argue that widely accepted guidelines support the provision of gender-affirming care for treating individuals experiencing gender dysphoria, that these guidelines were developed under a rigorous and transparent process based on scientific evidence, and that prohibiting the coverage of gender-affirming care would cause irreparable harm to Medicaid recipients experiencing gender dysphoria in Florida. Further, the parties argue that the underlying “Generally Accepted Professional Medical Standards Determination on the Treatment of Gender Dysphoria” report issued by AHCA that the finalized rule is based upon is factually inaccurate and ignores the recommendations of the medical community.

August Dekker, et al., v. Secretary, Florida Agency for Health Care Administration, et al. (Filed 12/01/23)
In June 2023, a U.S. district judge found Florida’s prohibition of Medicaid coverage of gender-affirming care to be unconstitutional and blocked the policy from being enforced. This brief will be filed in support of the district court ruling in an appeal by the state of Florida.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

Vasquez & Covington v. Iowa Department of Human Services (Filed: 6/23/22)
This case challenges a 2019 amendment to Iowa’s Civil Rights Act which would allow state and local governments to decline to cover “sex reassignment surgery” or “any other cosmetic reconstructive or plastic surgery procedure related to transsexualism, hermaphroditism, gender identity disorder, or body dysmorphic disorder." In November 2021, a district court ruled that the denial of gender affirming surgery violated the Iowa state constitution and ordered the Iowa Department of Human Services to cover such surgeries. The state appealed the district court’s ruling to the Iowa Supreme Court, which is where this brief was filed. ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports LGBT-inclusive policies that benefit the overall health and well-being of these populations and opposes legislation with discriminatory intent upon individuals based on gender identity.

ACP’s policy calls on public and private payers to cover/ comprehensive transgender health services, as well as opposes discrimination on the basis of gender identity. In this amicus brief, the interested parties argue that individuals with gender dysphoria living without gender affirming care may experience debilitating distress, depression, impairment of function, self-injurious behaviors, and suicide; and that treatments for gender dysphoria are medically necessary and may be urgent.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

A.C. v. Metropolitan School District of Martinsville and Principal, John R. Martin Middle School (Filed: 8/2/2022)
This case involves a 13-year-old transgender student (A.C.) of John R. Martin Middle school who was not permitted to use the restroom aligned with his gender identity. This policy made the student feel singled out, resulting in anxiety, depression, and stigmatization. A.C. and his mother filed a lawsuit against the district and a district judge issued a preliminary injunction ordering the school district to allow A.C. to use facilities aligned with his gender identity. This brief was filed in support of A.C. in an appeal by the Metropolitan School District against the preliminary injunction.

ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports LGBT-inclusive policies that benefit the overall health and well-being of these populations. We believe the spirit of this policy extends to the issue of “bathroom bills” and the ability of transgender individuals, including youth, to have access to facilities that are in line with their gender identity. In this amicus brief, the interested parties argue that exclusionary policies such as this expose transgender individuals to harassment and abuse, exacerbate stigma and discrimination, harm social and emotional development, and are contrary to widely accepted, evidence-based treatment protocols.

See additional relevant ACP advocacy in the Public Health Increasing Health Care Equity section.

Jane Doe 1, et al., v. William C. Thornbury, Jr. et al. (Filed: 5/22/2022)
This case challenges Kentucky Senate Bill 150, which seeks to ban gender affirming care for minors. The bill was vetoed by the governor, but the legislature voted to override this veto. This brief was filed on behalf of the plaintiffs, several minors who are transgender, who argue that this ban violates their constitutional rights and, if it goes into effect, will cause serious harm.

ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations and calls on public and private payers to cover comprehensive transgender health services. In this amicus brief, the interested parties argue that gender dysphoria treatment guidelines were developed through a robust and transparent process and include medical interventions for some adolescents. They further argue that a ban on this care would irreparably harm many adolescents by denying them the treatment they need.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

Dee Fulcher, Guiliano Silva, and the Transgender American Veterans Association, v. Secretary of Veterans Affairs (Filed: 6/28/2017)
In June 2016, the Department of Veterans Affairs (VA) announced it would undergo rulemaking to remove a ban on coverage of gender-affirming surgeries for veterans. The Office of Management and Budget denied this proposal, and the VA withdrew consideration of rulemaking. The petitioners in this case, two veterans seeking gender affirming surgery, filed a petition in the United States Court of Appeals for the Federal Circuit requesting a review of the VA’s denial of coverage for gender-affirming surgery and to direct the VA to undertake rulemaking to amend or repeal the ban. ACP’s overall policy on lesbian, gay, bisexual, and transgender (LGBT) disparities supports policies that benefit the overall health and well-being of the LGBTQ+ populations. In this amicus brief, the interested parties argue that gender-affirming surgery is a clinically effective, medically necessary treatment for certain patients diagnosed with gender dysphoria. They further argue that appropriate treatment of patients with gender-dysphoria is necessary to prevent physical and emotional harm.

In Re Transgender American Veterans Association (Filed: 1/29/2024)
In response to legal pressure, the VA sought public comment on the above rulemaking petition in 2018. Despite obtaining public comment and making numerous announcements regarding a rule change over the years, no further action was taken on the petition. This brief will be filed in support of a petition for mandamus that will be filed in the U.S. Court of Appeals for the Federal Circuit that seeks to initiate VA action. The plaintiffs allege that in stalling for more than seven years, the VA is violating statutory requirements under the Administrative Procedures Act and other law to "not engage in unreasonable delay" and to "resolve matters presented to it within a reasonable time."

Transgender American Veterans Association, v. Secretary of Veterans Affairs (Filed: 9/3/2024)
In February 2024, the VA formally denied the Transgender American Veteran Association’s (TAVA) 2016 petition and the court dismissed the petition for mandamus, forcing the VA to act. This brief was filed in the U.S. Court of Appeals for the Federal Circuit on behalf of TAVA’s appeal of the VA’s denial of coverage for gender-affirming care.

See additional relevant ACP advocacy in the Access to Care and Public Health Increasing Health Care Equity sections.

State of Mississippi, et al., v. Xavier Becerra, in his official capacity as Secretary of Health and Human Services, et al. (Filed: 11/12/2024)
In 2015, the bipartisan Medicare Access and CHIP Reauthorization Act of 2015 was signed into law, altering how the government reimburses physicians under Medicare. The law created the MIPS program, which evaluated physician scores in four categories, including “Improvement Activities.” Physicians must complete 2-4 activities in this category, and one of 104 available activities is the option to “Create and Implement an Anti-Racism Plan.” In 2022, several physicians and states filed a complaint against the measure, alleging that anti-racism efforts are discriminatory and violate constitutional principles of racial equality.

ACP has extensive policy on addressing racism and health and racial and ethnic disparities in health and health care. ACP explicitly commits to being an antiracist organization and undertaking efforts to eliminate racism from the practice of medicine. In this amicus brief, the interested parties argue that anti-racism initiatives are essential to improving clinical practice and health outcomes for all patients. They further argue that marginalized populations are at increased risk for adverse health outcomes and receive lower quality care and reduced access to treatments due to social determinants of health and medical racism and bias. This brief was filed with the district court in support of the federal government’s position that antiracism plans can result in improved health outcomes and are appropriate to be one improvement activity option.

See additional relevant ACP advocacy in the Racial Health Disparities section.

Students for Fair Admissions, Inc., v. President and Fellows of Harvard College and Students for Fair Admissions, Inc., v. University of North Carolina (UNC), et al. (Filed: 7/2022)
This case is a combination of two cases addressing affirmative action policies. This brief was filed in the Supreme Court in support of Harvard and UNC policies intended to foster educational diversity.

ACP policy supports measures that would improve diversity within the physician workforce and states that “institutions of higher education should appropriately consider a person’s race and ethnicity as one factor in determining admission in order to counter the impact of current discriminatory practices and the legacy of past discrimination practices and better reflect the current composition of the population.” In this amicus brief, interested parties argue that diversity is vital to health outcomes and in turn to the educational missions of the nation’s medical schools, and that limiting or precluding holistic review would result in a compounding loss of diversity and threaten patients' health.

See additional relevant ACP advocacy in the Racial Health Disparities section.

Commonwealth of Kentucky, et al., v. Environmental Protection Agency, et al. (Filed: 12/6/2024)
In March 2024, the EPA finalized multi-pollutant emissions standards for new passenger cars, light-duty trucks, and larger pickup trucks and vans. The standards will reduce emissions of greenhouse gases and other air pollutants associated with a range of acute and chronic health problems. Kentucky and 24 states filed a lawsuit challenging the EPA’s authority to set emissions standards for future model year vehicles. This brief was filed on behalf of the EPA and 22 states supporting the emissions standards in the U.S. Court of Appeals for the D.C. Circuit.

ACP policy calls for a global effort to reduce human-caused greenhouse gas emissions and address the health impacts of climate change. ACP has previously supported the EPA's nationwide emissions standards for new vehicles and has advocated for stronger vehicle emissions standards. In this amicus brief, the interested parties argue that exposure to light- and medium-duty vehicle emissions harms public health, disproportionately impacting the health of historically disadvantaged populations.

See additional relevant ACP policy in the Public Health Climate Change section.

State of Ohio, et al., v. United States Environmental Protection Agency, et al. (Filed: 1/20/2023)
This case involves a waiver granted to California by the Environmental Protection Agency (EPA) that allows the state to adopt more stringent emissions standards than required by the Clean Air Act. Other states are also permitted to adopt California’s more stringent standards. This brief was filed on behalf of California against challenges from other states over the legality of the waiver.

ACP policy calls for a global effort to reduce human-caused greenhouse gas emissions and address the health impacts of climate change. ACP has supported California’s emissions waiver and the EPA’s nationwide emissions standards for new vehicles. In this amicus brief, the interested parties argue that the Advanced Clean Car program reduces criteria pollutants and greenhouse gases to facilitate California’s compliance with the Clean Air Act, as well as responds to the compelling and extraordinary conditions in California caused by air pollution and climate change which both have harmful impacts on public health.

See additional relevant ACP policy in the Public Health Climate Change section.

State of Texas, et al., v. United States Environmental Protection Agency, et al. (Filed: 3/3/2023)
This case involves greenhouse gas emission standards for passenger cars and light trucks finalized by the Environmental Protection Agency (EPA) in 2021. This brief was filed on behalf of the EPA in a challenge of the new, more stringent, standards by several states and trade organizations who argue that the new standards exceed the EPA’s authority.

ACP policy calls for a global effort to reduce human-caused greenhouse gas emissions and address the health impacts of climate change. ACP has also stated support for the EPA’s nationwide emissions standards for new vehicles. In this amicus brief, the interested parties argue that the EPA’s Standards reduce vehicle emissions that harm public health, consistent with the Clean Air Act’s purpose of promoting public health.

See additional relevant ACP policy in the Public Health Climate Change section.

Novartis Pharmaceuticals Corp., v. Novo Nordisk, Inc., et al., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 2/2/2024)
The 2022 Inflation Reduction Act (IRA) includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Novo Nordisk, the manufacturer of the diabetes treatment drug NovoLog, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices. Novo Nordisk raises First Amendment objections to the program and alleges that the statute violates constitutional separation of powers and due process protections. Novo Nordisk also alleges that CMS violated the Administrative Procedures Act in its promulgation of the IRA and the Social Security Act, and that it acted beyond its authorities delegated by Congress. Novo Nordisk is seeking an order to enjoin the company from having to enter into any agreements around drug prices with CMS under the IRA, find the program unconstitutional, and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Access to Care section.

Novartis Pharmaceuticals Corp., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 1/19/2024)
The 2022 Inflation Reduction Act (IRA) includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Novartis Pharmaceuticals, the manufacturer of the heart failure treatment drug Entresto, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices. Novartis alleges the process violates its 5th Amendment procedural due process rights, argues the excise tax violates 8th Amendment protections against excessive fines, and raises 1st Amendment objections related to unlawfully compelled speech. Novartis is seeking an order to enjoin the company from having to enter into any agreements around drug prices with CMS under the IRA, find the program unconstitutional, and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Access to Care section.

Boehringer Ingelheim Pharmaceuticals, v. United States Department of Health and Human Services, et al. (Filed: 12/22/2023)
The 2022 Inflation Reduction Act (IRA) includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Boehringer Ingelheim Pharmaceuticals (BIP), the manufacturer of the diabetes and heart failure treatment drug Jardiance, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices. BIP alleges that Congress violated the Nondelegation Clause by permitting HHS to engage in price negotiation without adequate guidance and argues that the process violates its 5th Amendment procedural due process rights. BIP also alleges the regulatory process for establishing the drug price negotiation program did not follow the Administrative Procedures Act.

BIP is seeking an order to enjoin the company from having to enter into any agreements around drug prices with CMS under the IRA, find the program unconstitutional, and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program. ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Access to Care section.

Dayton Area Chamber of Commerce, et al., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 12/19/2023)
The 2022 Inflation Reduction Act (IRA) includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In 2023, the Dayton Area Chamber of Commerce, along with the Ohio Chamber of Commerce, Michigan Chamber of Commerce, and U.S. Chamber of Commerce filed a motion for preliminary injunction with the U.S. District Court for the Southern District of Ohio challenging CMS’ authority to negotiate prescription drug prices.

The organization's membership includes numerous pharmaceutical manufacturers subject to the provisions of the IRA. In their memorandum, the Chamber of Commerce alleges that the provisions of the IRA are a violation of 1st and 5th Amendment constitutional rights. ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Access to Care section.

AstraZeneca Pharmaceuticals LP & AstraZeneca AB, v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 11/8/2023)
The 2022 Inflation Reduction Act (IRA) includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, AstraZeneca, the manufacturer of the diabetes, heart failure, and chronic kidney disease treatment drug Farxiga, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices. AstraZeneca argues that the provisions of the IRA are a violation of the authorities granted to HHS by statute and that the process violates its 5th Amendment procedural due process rights, and is seeking to nullify any agreements around drug prices it enters with CMS under the IRA, and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

AstraZeneca Pharmaceuticals LP & AstraZeneca AB, Bristol Myers Squibb Company, Janssen Pharmaceuticals, Inc., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed 9/16/2024)

On April 29, 2024, the District Court in New Jersey ruled that the Inflation Reduction Act’s drug price negotiation provisions do not violate the First or Fifth Amendments as argued by BMS. BMS appealed the decision, and the appeal was combined with appeals by pharmaceutical companies Janssen and AstraZeneca. The updated brief was filed in the US Court of Appeals for the Third Circuit in support of drug price negotiation and access to prescription drugs for Medicare beneficiaries.

See additional relevant ACP advocacy in the Access to Care section.

Bristol Myers Squibb Company, v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 10/23/2023)
The 2022 Inflation Reduction Act includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Bristol Myers Squibb (BMS), the manufacturer of the blood clot prevention and treatment drug Eliquis, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices on the grounds that it violates the First and Fifth amendments. In its challenge, BMS is seeking to nullify any agreements around drug prices it enters with CMS under the IRA and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Access to Care section.

Janssen Pharmaceuticals, Inc., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 10/23/2023)
The 2022 Inflation Reduction Act includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Janssen Pharmaceuticals, the manufacturer of blood clot prevention and treatment drug Xarelto, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices on the grounds that it violates the First and Fifth amendments. In its challenge, Janssen is seeking to nullify any agreements around drug prices it enters with CMS under the IRA and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Access to Care section.

Merck & Co., Inc., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 9/18/2023)
The 2022 Inflation Reduction Act includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Merck, the manufacturer of the diabetes drug Januvia, which was selected for negotiation, filed a lawsuit challenging HHS’ authority to negotiate prescription drug prices on the grounds that it violates the First and Fifth amendments.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Access to Care section.

Vivek H. Murthy, Surgeon General, et al. v. Missouri, et al. (Filed: 12/22/2023)
Throughout the COVID-19 pandemic, the federal government was in communications with major social media platforms regarding their policies around moderating content on COVID-19, including on treatment, vaccine, and mask efficacy as well as the lab leak origin theory. In some cases, White House and Department of Health and Human Services (HHS) officials flagged specific content that they urged social media platforms to remove on the basis of violating the platforms' terms of service.

In 2022, two states and five social media users filed a lawsuit alleging that the government’s engagement and communications with social media platforms about moderating the posts of users constituted government-coerced speech and violated First Amendment constitutional rights. This case worked its way through the appeals process and is now being heard in the Supreme Court. ACP’s overall policy on strengthening the public health infrastructure and pandemic preparedness explicitly supports federal efforts to address public health dis- and misinformation. ACP policy specifically calls on the federal government to “partner with social media and other outlets to elevate evidence-based, credible sources.” In this amicus brief, the interested parties argue that misinformation about vaccines meaningfully interferes with their lifesaving role in a well-functioning public health system and has contributed to declining vaccine uptake.

See additional relevant ACP advocacy in the COVID-19 Advocacy section.

State of Georgia, et al., v. The President of the United States, et al. (Filed: 12/14/2021)
This case involves a 2021 executive order directing all federal agencies, as well as covered federal contractors and subcontractors, to ensure that all federal contracts moving forward require compliance with and implementation of guidance published by the Safer Federal Workforce Task Force.

This task force issued guidance requiring employees of covered contractors to be vaccinated against COVID-19, which was challenged by several states. This brief was filed on behalf of the Biden Administration in an appeal of a preliminary injunction preventing the enforcement of the vaccine mandate nationwide. ACP has issued several policy positions and other statements supporting laws to promote the uptake of recommended vaccinations. In this amicus brief, the interested parties argue that COVID-19 poses a grave danger to the health of federal contractor employees and that vaccines provide a safe and effective way to reduce transmission and increase workplace safety.

See additional relevant ACP advocacy in the COVID-19 Advocacy section.

Commonwealth of Kentucky, et al., v. Joseph R. Biden, et al. (Filed: 12/14/2021)
This case involves a 2021 executive order directing all federal agencies, as well as covered federal contractors and subcontractors, to ensure that all federal contracts moving forward require compliance with and implementation of guidance published by the Safer Federal Workforce Task Force. This task force issued guidance requiring employees of covered contractors to be vaccinated against COVID-19, which was challenged by several states.

This brief was filed on behalf of the Biden Administration in an appeal of a preliminary injunction preventing the enforcement of the vaccine mandate in Kentucky, Ohio, and Tennessee. ACP has issued several policy positions and other statements supporting laws to promote the uptake of recommended vaccinations. In this amicus brief, the interested parties argue that COVID-19 poses a grave danger to the health of federal contractor employees and that vaccines provide a safe and effective way to reduce transmission and increase workplace safety.

See additional relevant ACP advocacy in the COVID-19 Advocacy section.

National Federation of Independent Businesses, et al., v. Department of Labor, Occupational safety and Health Administration, et al.; Ohio, et al., v. Department of Labor, Occupational Safety and Health Administration, et al. (Filed: 2021)
This case involves a 2021 Occupational Safety and Health Administration (OSHA) rule that requires employers with 100 or more employees to ensure that each of their employees is vaccinated against COVID-19, as well as to provide paid-time off for employees to obtain a vaccination. An emergency stay was issued halting enforcement of the rule, which was challenged in over 34 lawsuits that were combined in this case. ACP has issued several policy positions and other statements supporting laws to promote the uptake of recommended vaccinations. In this amicus brief, the interested parties argue that COVID-19 poses a grave danger to the health of workers and that vaccines provide a safe and effective way to reduce transmission and increase workplace safety.

See additional relevant ACP advocacy in the COVID-19 Advocacy section.

State of Missouri, et al., v. Joseph R. Biden, Jr., et al. (Filed: 12/07/2021)
This case involves a Centers for Medicare and Medicaid Services (CMS) interim final rule requiring eligible workers in health care settings to be fully vaccinated against COVID-19 with limited exceptions. A preliminary injunction was issued blocking enforcement of the rule in the 10 states that challenged it, and later, nationwide. This brief was filed on behalf of CMS in an appeal of the injunction. ACP has issued several policy positions and other statements supporting laws to promote the uptake of recommended vaccinations. In this amicus brief, the interested parties argue that COVID-19 poses a grave danger to the health of health care facility staff and patients and that vaccines provide a safe and effective way to reduce transmission and protect health care facility staff and patients from COVID-19.

See additional relevant ACP advocacy in the COVID-19 Advocacy section.

Jonathan Roberts, et al., v. Mary T. Bassett, et al. (Filed: 2/28/2022)
This case involves a notification issued by the New York Department of Health including a description of eligibility for oral antiviral COVID-19 treatment in which “Non-white race or Hispanic/Latino ethnicity should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from COVID-19.” The notification was challenged but the case was dismissed, and this brief was filed on behalf of the New York Department of Health in an appeal against the decision.

ACP believes that policymakers should recognize and address how increases in the frequency and severity of public health crises, including large-scale infectious disease outbreaks, poor environmental health, and climate change, disproportionately contribute to health disparities for Black, Indigenous, Latinx, Asian American, Native Hawaiian, Pacific Islander, and other vulnerable persons. In this amicus brief, the interested parties argue that minoritized populations are at heightened vulnerability to severe illness and death from COVID-19, which is tied to systemic racism and bias, and thus considering a person’s race or ethnicity in evaluating their risk of severe progression of COVID-19 is justified.

See additional relevant ACP advocacy in the COVID-19 Advocacy and Racial Health Disparities sections.

William A. Jacobson v. Mary T. Bassett (Filed: 2/23/2022)
This case involves a notification issued by the New York Department of Health (NYDOH) including a description of eligibility for oral antiviral COVID-19 treatment in which “Non-white race or Hispanic/Latino ethnicity should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from COVID-19.” The notification was challenged by America First Legal, and this brief was filed on behalf of the NYDOH.

ACP believes that policymakers should recognize and address how increases in the frequency and severity of public health crises, including large-scale infectious disease outbreaks, poor environmental health, and climate change, disproportionately contribute to health disparities for Black, Indigenous, Latinx, Asian American, Native Hawaiian, Pacific Islander, and other vulnerable persons. In this amicus brief, the interested parties argue that minoritized populations are at heightened vulnerability to severe illness and death from COVID-19, which is tied to systemic racism and bias, and thus considering a person’s race or ethnicity in evaluating their risk of severe progression of COVID-19 is justified.

See additional relevant ACP advocacy in the COVID-19 Advocacy and Racial Health Disparities sections.

Braidwood Management, Inc., et al., v. Xavier Becerra as Secretary of Health and Human Services, et al. (Filed: 6/27/2023)
This case involves a challenge to the Affordable Care Act’s (ACA) preventative service coverage requirement on the grounds that it violates religious beliefs and the Appointments Clause because the advisory boards were not appointed by the President and approved by Congress. A district court judge struck down some of the preventative coverage requirements, but this decision was stayed in appeals court. This brief was filed on behalf of Secretary Becerra in defense of the preventative service coverage requirement.

ACP has several policy statements supporting coverage of preventive services without cost sharing, including support for all insurance plans to cover an evidence-based essential health benefit package. In this amicus brief, the interested parties argue that encouraging patients to obtain preventative care improves health outcomes and the overall functioning of the health system. Additionally, they argue that the ACA significantly expanded access to no-cost preventative care and affirming the judgement to strike down some of the preventative coverage requirements would imperil access to preventative care for millions of Americans.

Xavier Becerra, Secretary, U.S. Department of Health and Human Services, et al., v. Braidwood Management, Inc. et al. (Filed: 10/21/2024)
In June 2024, the Fifth Circuit Court of Appeals ruled that the requirement to cover USPSTF-recommended preventive services without cost-sharing was unconstitutional. However, the decision only applies to the plaintiffs, rather than all health plans nationwide, so the plaintiff is no longer required to abide by the preventive services coverage mandate. The federal government has appealed the ruling and filed a petition for writ of certiorari requesting the U.S. Supreme Court consider the case. This brief was filed in support of the federal government's petition for certiorari, requesting the U.S. Supreme Court consider and reverse the lower court's decision.

See additional relevant ACP advocacy in the Access to Care section.

Merrick B. Garland, Attorney General, et al., v. Micheal Cargill (Filed: 12/26/2023)
Prior to 2018, the federal Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) maintained that bump stocks were not machine guns as defined by statute. After the public outrage following the October 1, 2017 Las Vegas shooting which involved bump stocks, the ATF changed its stance, reclassifying bump stocks as machine guns and exposing owners to criminal liability. Michael Cargill surrendered his bump stocks due to this new regulation and filed a lawsuit challenging the ATF regulations, arguing that the ATF exceeded its authority in defining bump stocks as machine guns. The district court ruled in favor of the government and its new definition, but the appeals court reversed this decision. The Supreme Court will now hear this case to determine if a bump stock is a machine gun as defined by U.S. statute.

ACP policy favors enactment of legislation to ban the manufacture, sale, transfer, and subsequent ownership for civilian use of semiautomatic firearms that are designed to increase their rapid killing capacity. In this amicus brief, the interested parties argue that bump stocks are a public health issue and should be defined as machine guns, and present testimonies from physicians who have firsthand knowledge of the deadly effects of bump stocks and semi-automatic weapons.

See additional relevant ACP advocacy in the Public Health Firearms section.