On February 20, 2025, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced the recission of “HHS Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy” (the “Rescinded 2022 Guidance”) pursuant to recent Executive Order (“EO”) 14187 (“Protecting Children from Chemical and Surgical Mutilation”) and EO 14168 (“Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government”), issued under the current Trump administration.
These executive orders directed HHS to revoke policies promoting gender-affirming care and reconsider its interpretation of civil rights protections and health information privacy laws as they relate to such care.
Background on the Rescinded 2022 Guidance
The Rescinded 2022 Guidance, originally issued on March 2, 2022 under the Biden administration, and which we previously discussed here, established a framework for applying federal civil rights protections and patient privacy laws to gender-affirming care in three key ways:
- Section 1557 of the Affordable Care Act (ACA): The Rescinded 2022 Guidance asserted that federally funded entities restricting access to gender-affirming care could be in violation of Section 1557, which prohibits discrimination based on sex, including gender identity.
- Section 504 of the Rehabilitation Act and the Americans with Disabilities Act (ADA): The Rescinded 2022 Guidance took the position that gender dysphoria could qualify as a disability, meaning that restricting access to care based on gender dysphoria could constitute unlawful discrimination.
- Health Insurance Portability and Accountability Act of 1996 (HIPAA): The Rescinded 2022 Guidance interpreted HIPAA’s Privacy Rule to prohibit the disclosure of protected health information (PHI) related to gender-affirming care without the patient’s authorization, except in limited circumstances when explicitly required by law.
HHS Bases for the Rescission
OCR Acting Director, Anthony Archeval, stated that the “recission is a significant step to align civil rights and health information privacy enforcement with a core Administrative policy that recognizes that there are only two sexes: male and female.” The HHS Office on Women’s Health also issued guidance expanding on the sex-based definitions set forth in the EO 14168. This HHS guidance contained the following definitions:
- Sex: A person’s immutable biological classification as either male or female.
- Female: is a person of the sex characterized by a reproductive system with the biological function of producing eggs (ova). We note that EO 14168 defines female in a slightly different manner to mean “a person belonging, at conception, to the sex that produces the large reproductive cell.”
- Male: is a person of the sex characterized by a reproductive system with the biological function of producing sperm. We note that EO 14168 defines female in a slightly different manner to mean “a person belonging, at conception, to the sex that produces the small reproductive cell.”
In its February 20, 2025 press release, HHS further stated that “[t]his rescission supports Administration policy in Executive Order 14187 that HHS will not promote, assist, or support “the so-called ‘transition’ of a child from one sex to another, and it will rigorously enforce all laws that prohibit or limit these destructive and life-altering procedures.”
Further, OCR’s formal recission letter dated February 20, 2025, outlining several reasons leading to the Rescinded 2022 Guidance:
- ACA (Section 1557): HHS cited recent federal cases, Texas v. EEOC and Bostock v. Clayton County, as calling into question the legal basis for extending Section 1557 protections to gender identity. But see Kadel v. Folwell, 2024 WL 1846802 (4th Cir. 2024) (On May 8, 2024, the Fourth Circuit affirmed the trial court rulings that the exclusion of coverage for gender affirming care by state health plans in West Virginia and North Carolina violated the nondiscrimination protections of the Affordable Care Act (ACA) Section 1557).
- Rehabilitation Act and ADA: HHS argued that gender dysphoria does not meet the statutory definition of a disability, as the law explicitly excludes gender identity-related conditions unless resulting from a physical impairment. However, the Fourth Circuit, in Williams v. Kincaid, 45 F. 4th 759, 770 (4th Cir. 2022), concluded that gender dysphoria is a disability protected under the ADA and does not fall within the ADA’s exclusion for “gender identity disorders not resulting from physical impairments.” See also Blatt v. Cabela’s Retail, Inc., 2017 WL 2178123 (E.D. Pa. May. 18, 2017) (Plaintiff’s gender dysphoria, which substantially limits her major life activities of interacting with others, reproducing, and social and occupational functioning, is not excluded from ADA protection.)
- HIPAA: HHS stated that the Rescinded 2022 Guidance lacked a legal foundation for restricting PHI disclosures beyond HIPAA’s established exceptions. However, we note that current established exceptions already allow disclosures without patient authorization in certain circumstances, including when required by law. Interestingly, the new reproductive health amendments to HIPAA, which became effective on December 23, 2024, may, if interpreted broadly, provide additional privacy protections to information related to gender affirming care.
In addition to the recission, HHS also announced its launch of HHS’ Office on Women’s Health website, which we reference above, to promote these policies.
Impact on HIPAA and Patient Privacy
In the wake of the Rescinded 2022 Guidance and associated OCR statements, it remains unclear how OCR will now handle complaints related to the use and disclosure of PHI concerning gender-affirming care. Accordingly, entities that handle such data should carefully review their internal policies to ensure compliance with evolving interpretations of HIPAA’s Privacy Rule.
However, entities should also consider the HIPAA Privacy Rule to Support Reproductive Health Care Privacy, finalized in April 2024, which broadly defines “reproductive health care.” Gender-affirming care often falls within this definition, meaning that certain privacy protections may still apply under this rule despite the Rescinded 2022 Guidance. While HHS’s recent actions suggest a lack of intent to defend this interpretation, the 2024 reproductive health rule remains in effect despite ongoing litigation in Texas challenging these amendments. On September 8, 2024, the Texas Attorney General, in litigation pending in the Northern District of Texas, claimed that the new rule harms the AG’s ability to investigate medical care, lacks statutory authority, and is arbitrary and capricious. This litigation is still pending.
Compliance and Legal Considerations
- Federal vs. State Law Conflicts: Entities must navigate the potential conflicts between state laws and the rescission of the Rescinded 2022 Guidance. For instance, Colorado and California have laws explicitly protecting access to gender-affirming care, which could create legal complexities for providers and insurers operating under multiple jurisdictions.
- Litigation and Injunctions: On March 4, 2025, a federal judge in Maryland issued a preliminary injunction enjoining federal agencies from issuing regulations or guidance or otherwise implementing mandates of EO 14187. This injunction applies nationwide. In a more limited fashion, a judge in Washington issued a preliminary injunction which applies only to Washington, Colorado, Minnesota, and Oregon. As the Maryland court is still deciding on the merits of the case before it, entities should monitor these legal developments to understand go forward compliance obligations under both federal and state regulations.
- Potential Whistleblower Protections. EO 14187 also directs HHS, in consultation with the Attorney General, to “issue new guidance protecting whistleblowers who take action related to ensuring compliance with this order.” Accordingly, it is possible that under such contemplated guidance, an increase in whistleblower-initiated compliance investigation may ensue. Yet, such increase in whistleblowing as an avenue to evaluate compliance would not address the potential friction between the requirements under the HIPAA Privacy Rule to Support Reproductive Health Care Privacy.
- Threats to Funding. On March 5, 2025, numerous health care providers enrolled in the Medicare and Medicaid programs received a letter from CMS stating that “CMS may begin taking steps in the future to align policy, including CMS-regulated provider requirements and agreements, with the highest-quality medical evidence in the treatment of the nation’s children” as it relates to gender affirming care. The following day, on March 6, 2025, SAMHSA and HRSA sent similar letters to Hospital Administrators and Grant Recipients referencing the March 5, 2025 CMS letter and threatening examination of current grants and the “re-scoping, delaying or potentially cancelling new grants in the future” depending upon the nature of the work being performed by the providers and/or grant recipients as it relates to gender affirming care for minors.
Key Takeaways
The rescission of the 2022 “HHS Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy” seeks to align HHS’s policies with the Trump administration’s stance on gender-affirming care. The recission introduces financial and compliance challenges for entities regulated by the HHS. However, the recission of the Rescinded 2022 Guidance does not eliminate all HIPAA provisions related to reproductive health and other state-level protections may still provide certain privacy and anti-discrimination safeguards relative to individuals seeking gender affirming care. Given this uncertainty, organizations should revisit their policies and procedures, closely monitor the evolving regulatory landscape, and keep a close eye on litigation outcomes to ensure continued compliance.