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Legal E-Bulletin - September 2022

Review of HHS OCR Notices Relating to Discrimination on the Basis of Sex and Disability in Regard to Healthcare Services and Dispensation of Medications in Connection with Gender-Affirming and Reproductive Healthcare

Diego Demaya, J.D.

I. Introduction

The Southwest ADA Center (SWADA) is one of ten regional ADA technical assistance centers focusing on the civil rights of individuals with disabilities in regard to discrimination in employment, education, public services, private business, and architectural access to facilities and transportation. Among other specialized technical assistance and research projects, SWADA focuses on access to healthcare by individuals with disabilities. As part of that project, this Legal E-Bulletin reviews two consecutive public notices of enforcement issued by the U.S. Department of Health and Human Services pertaining to discrimination on the basis of sex and disability in connection to denial of gender affirming healthcare and reproductive healthcare medication and services.

This review constitutes neither legal advice nor a political position on any issues discussed herein. This eBulletin is aimed at providing clarification and illustration regarding the applicability of the Americans with Disabilities Act (ADA)[1], Section 504 of the Rehabilitation Act,[2] and Section 1557 of the Affordable Care Act to healthcare services[3].

II. Enforcement of Civil Rights Relating to Gender-Affirming Health Care

On March 2, 2022, the Office for Civil Rights (OCR) in the U.S. Department of Health and Human Services (HHS) published HHS Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy.[4] The Notice served to affirm HHS OCR’s intent to investigate and enforce Section 1557 of the Affordable Care Act (Section 1557) in cases involving complaints of discrimination on the basis of sexual orientation and gender identity. OCR also reminded covered entities that it will enforce Section 504 of the Rehabilitation Act of 1973, as Amended by the ADA Amendments Act of 2008[5], (“Section 504”) that protects individuals with disabilities from discrimination in programs and activities that receive financial assistance from HHS. Moreover, OCR warned that the unauthorized disclosure of Protected Health Information (PHI) relating to gender affirming care will constitute a violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA)[6].

OCR clarified that the March 2022 notice and guidance is intended to directly combat state laws, regulations, and gubernatorial orders that require or allow health care providers, including pharmacists, to disclose and/or report private patient information related to gender-affirming care or restrict health care providers from delivering care because of the gender identity of a patient.  The Notice stated that HHS stands with transgender and gender-nonconforming youth and their families—and the significant majority of expert medical associations—in unequivocally stating that gender-affirming care for minors, when medically appropriate and necessary, improves their physical and mental health.

OCR therefore warned that attempts to restrict, challenge, or falsely characterize such potentially lifesaving care as “abuse” is dangerous. OCR explained that when such attempts block parents from making critical health care decisions for their children, they create a chilling effect on health care providers who provide appropriate and necessary care to the extent that such interference may ultimately negatively impact the health and well-being of transgender and gender nonconforming youth.

A. Applicable Laws and Background

Section 1557 of the ACA. Section 1557 of the Affordable Care Act (Section 1557) prohibits discrimination on the basis of race, color, national origin, age, disability, or sex (including pregnancy, sexual orientation, gender identity, and sex characteristics), in covered health programs or activities. 42 U.S.C. 18116[7].  It is important to note that a health care provider does not have to receive federal funds to be covered by the Affordable Care Act—e.g., anyone paying for health care or medication out of pocket or via any group or private health care plan.

Whether prohibiting gender-affirming care is considered discrimination under Section 1557 and other federal laws has been a subject for debate based on “sex stereotyping” by presidential administrations.  In June 2020, the Trump administration HHS issued a final rule implementing Section 1557 (“2020 Rule”) that significantly narrowed the scope of the rule issued in 2016 by the previous Obama administration HHS (“2016 Rule”).  Notably, the 2020 Rule reinterpreted the regulatory definition of “sex” for purposes of assessing discrimination under Section 1557 as only referring to biological sexes of male and female.  This effectively overturned the more expansive interpretation in the 2016 Rule that included gender identity and sexual orientation within its purview. However, on August 17, 2020, the day before the Trump administration’s 2020 Rule would take effect, the Eastern District of New York issued a nationwide, preliminary injunction preventing implementation of the 2020 Rule provision that excludes sex stereotyping from the definition of sex discrimination in Walker v. Azar[8].  Additionally, in September 2020 the DC Federal District Court blocked implementation of the provision in the 2020 Rule that excludes sex stereotyping from the definition of sex discrimination in Whitman-Walker Clinic v. HHS[9].

Consequently, following these and other court cases, HHS issued a Federal Register notice in May 2021, clarifying that OCR will comply with all applicable court decisions, including Walker and Whitman-Walker, and interpret and enforce Section 1557’s prohibition on sex discrimination as including discrimination on the basis of both sexual orientation and gender identity. Thus, pursuant to the March 2022 HHS OCR notice, OCR will consider the categorical refusal to provide treatment to an individual based on their gender identity as prohibited discrimination under Section 1557.

Section 504 and the ADA. OCR also emphasized that restricting an individual’s ability to receive gender-affirming, medically necessary care from their health care provider may violate Section 504.  Recall that Section 504, as amended by the 2008 ADA Amendments Act, defines a disability as including a physical or mental impairment or medical condition that substantially limits a major life activity, regardless of expected duration (e.g., gender dysphoria).  As an example, OCR provided an illustration of a health care professional making a report to state authorities against a parent for seeking medical consultation regarding gender-affirming care for their child.  This case could represent a violation of Section 504 if the health care provider or clinic receives federal financial assistance and declines care or medication to an individual whose gender identity causes a medical condition that adversely affects a major life activity—e.g., concentrating, thinking, eating, digestion, sleeping, etc. Again, recall that a health care provider or pharmacy need not receive Federal funds from HHS to be covered by disability anti-discrimination laws including the Americans with Disabilities Act (ADA) pursuant to Title II covering public entities (e.g., local county hospital) and Title III covering public accommodations (e.g., private hospitals and pharmacies).

HIPAA. The March 2022 notice also reminded covered entities that the Health Insurance Portability and Accountability Act of 1996 (HIPAA) generally prohibits disclosure of protected health information (PHI) without patient consent, or in regard to a minor, parental or guardian written authorization.  This would include gender-affirming healthcare.  When required by law (i.e., court order), covered entities and business associates are permitted, but not required, by HIPAA to disclose PHI without authorization.  However, this exception only applies when the mandate is contained in a law that compels the entity to make a disclosure or use of PHI that is enforceable in a court of law.  Hence, a state or local law that requires or allows disclosure of otherwise protected Personal Health Information (PHI) will likely constitute a violation of HIPAA which is Federal law.Recall that Federal law trumps State and local laws that conflict with a Federal provision. Moreover, any healthcare entity affiliated with or run by a religious organization that receives federal funds, such as through Medicare or Medicaid, is not exempt from HIPAA obligations.

III. Enforcement of Civil Rights in Regard to Refusal by Healthcare Entities or Pharmacies to Dispense Prescribed Medication Associated with Reproductive Healthcare

On a parallel federal enforcement path, on July 13, 2022, HHS OCR issued guidance to retail pharmacies[10] (see: Guidance to Nation’s Retail Pharmacies: Obligations under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services) that refusing to dispense a prescribed medication, or making a determination on the suitability of a medication, on the basis of the patient’s sex, pregnancy, or pregnancy-related medical condition(s) may be deemed as discriminatory conduct in violation of Section 1557 of the Affordable Care Act and Section 504 of the Rehabilitation Act. The July 2022 guidance clarified that it would be considered a form of sex discrimination if pharmacies make suitability determinations or refuse to dispense on the basis of a patient’s pregnancy or related conditions such as past pregnancy, potential or intended pregnancy, and/or medical conditions related to pregnancy or childbirth. 

HHS OCR reminded covered entities that as recipients of federal funding, retail pharmacies are prohibited from discriminating on the basis of disability, race, color, national origin, sex, and age in their programs and activities. Moreover, citing HHS’s commitment to improving maternal health, reducing maternal death rates, and providing support during the experience of pregnancy loss, the guidance emphasized the role of retail pharmacies as America’s “most accessible healthcare provider” and the importance of providing care in a manner free from discrimination based on personal beliefs, stigma, misleading rhetorical information, or other discriminatory practices that interfere with individual rights as well as with the doctor-patient confidential relationship.

The July 2022 guidance provided illustrations of prohibited conduct that may violate Section 1557 and Section 504:

• A pharmacy refuses to fill prescriptions for medications needed to manage a miscarriage or complications from pregnancy loss because these medications could also be used to terminate a pregnancy. (Sex discrimination)
• A pharmacy refuses to fill a prescription or does not stock a prescription such as misoprostol, because of its alternate uses. (Disability discrimination)
• A pharmacy refuses to fill a prescription because it becomes aware that the medication is being taken as a lifesaving, preventive measure related to a scheduled surgical pregnancy termination. (Sex discrimination)
• A hospital pharmacy refuses to provide antibiotics required for treatment because of concern that subsequent care may include uterine evacuation via medicinal or surgical termination of pregnancy. (Sex discrimination)
• A medical provider orders methotrexate to halt an ectopic pregnancy and a pharmacy refuses to fill the prescription because it will halt the growing of cells and end the pregnancy. (Sex discrimination)
• An individual with rheumatoid arthritis that meets the definition of a disability under ADA/504 is prescribed methotrexate and the pharmacy refuses to fill the individual’s prescription or does not stock methotrexate because of its alternate uses. (Disability discrimination)
• An individual presents a prescription for an emergency contraceptive at their local pharmacy after a sexual assault to prevent pregnancy.  The pharmacy otherwise offers prophylactics (e.g., external and internal condoms), but refuses to fill the emergency contraceptive prescription because it can prevent ovulation or block fertilization. (Sex discrimination)
• A pharmacy offers prophylactics, but refuses to fill a prescription for hormonal contraceptives because they may prevent pregnancy. (Sex discrimination)

Regarding the above scenarios, it should be noted that any medical condition, regardless of duration and including any physical or mental diagnosis related to pregnancy or the termination of a pregnancy, may be a protected disability under the ADA and Section 504 if the medical condition is a physical or mental impairment that substantially limits one or more major life activities. A physical impairment can include, but is not limited to, walking, seeing, hearing, standing, working, breathing, concentrating, digestion, reproduction, etc.  A mental impairment can include, but is not limited to, any psychiatric or emotional disorder that affects an individual’s ability to sleep, concentrate, eat, think, work, etc.   

As with any agency-issued FAQ or hypothetical fact application, these illustrative cases should not be interpreted as an exhaustive list.  Retail pharmacies and the pharmacists they employ should carefully evaluate any scenario involving the refusal to fill a valid prescription as potentially discriminatory conduct. Recall that a private hospital or pharmacy may not discriminate pursuant to Section 1557 of the ACA and Title III of the ADA regardless whether they receive Federal funding.

The July 2022 guidance served to notify the nation’s approximately 60,000 retail pharmacies that refusing to fill a valid prescription because the medication may be used for pregnancy termination or for other reproductive care will draw an investigation. Similarly, if a medication otherwise used in reproductive health care has an alternate use in connection to other medical conditions or disabilities, and such medication is denied based on its association to reproductive care, this also will draw an OCR investigation. If an investigation results in the finding of a violation, entities can be subject to various levels of administrative and monetary penalties.  Recent resolution agreements may be reviewed on the OCR’s webpage.

IV. Recommended Practices and Observations

[Reminder: The HHS OCR notices reviewed herein are intended to provide federal guidance and clarity regarding existing requirements under applicable laws and HHS enforcement policies.  This legal eBulletin represents neither an opinion nor a political position on any given issue.]

Neither the March 2022 nor July 2022 HHS OCR notice addressed any potential religious exemptions that could be asserted by a healthcare entity or one of its providers related to the provision of gender-affirming care or dispensation of medications by pharmacies as prescribed by licensed medical professionals.  However, be aware that any healthcare entity affiliated with or run by a religious organization remains subject to federal regulation when it accepts or utilizes federal funds, including payments from Medicare, Medicaid, or state or local programs that themselves utilize federal funds.  Furthermore, HIPAA continues to apply to all healthcare institutions and/or pharmacies in regard to the unauthorized release of PHI.

In states with laws that may conflict with federal HHS regulations and guidance, health care providers and pharmacies should be aware that federal law preempts state law under the U.S. constitution, and should seek legal guidance on how to proceed in view of federal requirements pursuant to a civil rights statute or Federal enforcement mandate. In states where state legislation or a gubernatorial executive order allows licensed healthcare professionals to either refuse to dispense a duly prescribed medication or to provide medical treatment (including reproductive healthcare) without having to explain a reason for the denial, health care providers, including pharmacists, are not exempt from compliance or liability under federal civil rights laws including the Americans with Disabilities Act (ADA), Section 504, and/or Section 1557 of the ACA.

Healthcare providers and pharmacists should also be aware that in states where state legislation allows denial of healthcare and/or medications on the basis of personal moral objections, or without having to explain a reason for the denial, such state laws do not offer any legal indemnification or defense against legal action brought against entities and licensed professionals by individual plaintiffs or federal enforcement entities seeking to enforce a civil right or public health policy.  Moreover, recall that state attorneys general are limited to defending only state agencies, not individual state residents or private businesses.

Title III of the ADA covers public accommodations, including retail pharmacies and private healthcare providers, and prohibits discrimination on the basis of disability in the sale of goods and services.  The sale of goods and services includes retail prescription and non-prescription medication as well as health services provided by licensed physicians.  The ADA obligates public accommodations to make reasonable modifications to how goods and services are sold to individuals with disabilities in order to make such goods, services, and activities accessible to individuals with disabilities.  Section 504 provides the same non-discrimination protections based on disability while covering any entity, including faith-based healthcare providers and Rx businesses that accept federal funding such as payments from Medicare or Medicaid.

The ADA, and Section 504 as amended by the ADA Amendments Act of 2008, define a disability as (1) a physical or mental impairment that substantially limits one or more major life activities; (2) having a record or history of a disability; and (3) an individual who is “regarded as” having a disability—even if the person does not have a disability but is perceived by others as having a disability. A disability may be permanent, indefinite, or temporary—regardless of duration. A physical or mental impairment may include, but is not limited to, walking, seeing, thinking, concentrating, digestion, sleeping, hearing, standing, lifting, interacting with others, etc.

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The Southwest ADA Center is a program of ILRU (Independent Living Research Utilization), at TIRR Memorial Hermann in Houston, Texas. The Center is funded by grants (90DP0092 and 90DPAD0010) from the National Institute on Disability, Independent Living, and Rehabilitation Research. NIDILRR is a Center within the Administration for Community Living (ACL), Department of Health and Human Services (HHS). The contents of this e-bulletin do not necessarily represent the policy of NIDILRR, ACL, HHS, and you should not assume endorsement by the Federal Government.

For further technical assistance on the Americans with Disabilities Act (ADA) or other disability-related antidiscrimination laws contact:

Southwest ADA Center

Toll Free: (800) 949-4232 (TX, LA, OK, AR, NM)

Web: www.SouthwestADA.org

E-Mail: SWDBTAC@ILRU.ORG  

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