On July 13, 2022, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) issued guidance to the nation’s retail pharmacies about their nondiscrimination obligations to ensure access to reproductive health care services, including medications used to terminate pregnancies. As we previously discussed, the Biden Administration and OCR have been taking action as some states seek to restrict or criminalize abortion services in response to the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization.  

            In its latest guidance, entitled “Guidance to Nation’s Retail Pharmacies:  Obligations under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services,” OCR summarized the nondiscrimination obligations of pharmacies under Section 1557 of the Affordable Care Act (including Title IX of the Education Amendments of 1972, as applicable) and Section 504 of the Rehabilitation Act of 1973.

In pertinent part, pharmacies may not discriminate against pharmacy customers on the basis of sex or disability in relation to supplying medication; making determinations regarding the suitability of a prescribed medication for a patient; or advising patients about medications and how to take them. OCR provided the following examples related to reproductive health care, including abortion medications:

  • Prohibited discrimination on the basis of sex
    • An individual experiences an early pregnancy loss (first-trimester miscarriage) and their health care provider prescribes pretreatment with mifepristone followed by treatment with misoprostol to assist with the passing of the miscarriage. If a pharmacy refuses to fill the individual’s prescription—including medications needed to manage a miscarriage or complications from pregnancy loss, because these medications can also be used to terminate a pregnancy—the pharmacy may be discriminating on the basis of sex.
    • An individual presents to a hospital emergency department with chills, fever, and vaginal bleeding.  The treating physician diagnoses a miscarriage complicated by a uterine infection (known medically as a septic abortion) and orders an antibiotic.  If the hospital pharmacy refuses to provide the antibiotic required for treatment because of concern that subsequent care may include uterine evacuation (via medical or surgical abortion), the pharmacy may be discriminating on the basis of sex.
    • An individual who has been undergoing fertility treatments receives a positive pregnancy test.  After the individual expresses concern with symptoms associated with an ectopic pregnancy, their medical provider performs an ultrasound to determine where the pregnancy is developing.  The ultrasound indicates the fertilized egg is growing in a fallopian tube.  The medical provider orders methotrexate to halt the pregnancy.  If a pharmacy refuses to fill the prescription because it will halt the growing of cells and end the pregnancy, it may be discriminating on the basis of sex.
    • An individual presents a prescription for an emergency contraceptive at their local pharmacy after a sexual assault to prevent pregnancy.  If the pharmacy otherwise provides contraceptives (e.g., external and internal condoms) but refuses to fill the emergency contraceptive prescription because it can prevent ovulation or block fertilization, the pharmacy may be discriminating of the basis of sex.
    • An individual’s health care provider sends the individual’s prescription for hormonal contraception (e.g., oral contraceptive pill, emergency contraception, a patch placed on the skin, a contraceptive ring, or any other FDA-approved contraceptive product) to a pharmacy.  If the pharmacy otherwise provides contraceptives (e.g., external and internal condoms) but refuses to fill a certain type of contraceptive because it may prevent a pregnancy, the pharmacy may be discriminating on the basis of sex.
  • Prohibited discrimination on the basis of disability
    • An individual experiences severe and chronic stomach ulcers, such that their condition meets the definition of a disability under civil rights laws.  Their gastroenterologist prescribes misoprostol to decrease risk of serious complications associated with ulcers.  If the pharmacy refuses to fill the individual’s prescription or does not stock misoprostol because of its alternate uses, it may be discriminating on the basis of disability.
    • An individual with rheumatoid arthritis, such that their condition meets the definition of disability under civil rights laws, is prescribed methotrexate by their physician’s assistant as a standard immunosuppressive treatment. If the pharmacy refuses to fill the individual’s prescription or does not stock methotrexate because of its alternate uses, it may be discriminating on the basis of disability.

OCR also stated that pharmacies may not discriminate against health care personnel in relation to their employment due to their performance or assistance in the provision of abortion or sterilization care. This protection is set forth in the Church Amendments, codified at 42 U.S.C. § 300a-7, and described in OCR’s Guidance on Nondiscrimination Protections under the Church Amendments. OCR stated that it would evaluate and apply the Church Amendments protections on a case-by-case basis.  

Takeaways

We expect more guidance and policy changes addressing access to reproductive health care services in the near future. Particularly, we anticipate greater clarity once courts issue decisions (for e.g. in GenBioPro, Inc. v. Dobbs, Civil Action No. 3:20-cv-00652-HTW-LGI) on whether states have authority to restrict access to abortion medicine, which has been approved by the U.S. Food and Drug Administration (FDA) since 2000. In the meantime, pharmacies and clinicians will need to carefully navigate the new federal guidance and the intersection with state law.

We will continue to follow these developments.  For more information, please contact the professionals listed below, or your regular Crowell & Moring contact.

   

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Photo of Jodi G. Daniel Jodi G. Daniel

Jodi Daniel is a partner in Crowell & Moring’s Health Care Group and a member of the group’s Steering Committee. She is also a director at C&M International (CMI), an international policy and regulatory affairs consulting firm affiliated with Crowell & Moring. She…

Jodi Daniel is a partner in Crowell & Moring’s Health Care Group and a member of the group’s Steering Committee. She is also a director at C&M International (CMI), an international policy and regulatory affairs consulting firm affiliated with Crowell & Moring. She leads the firm’s Digital Health Practice and provides strategic, legal, and policy advice to all types of health care and technology clients navigating the dynamic regulatory environment related to technology in the health care sector to help them achieve their business goals. Jodi is a contributor to the Uniform Law Commission Telehealth Committee, which drafts and proposes uniform state laws related to telehealth services, including the definition of telehealth, formation of the doctor-patient relationship via telehealth, creation of a registry for out-of-state physicians, insurance coverage and payment parity, and administrative barriers to entity formation.

Photo of Lidia Niecko-Najjum Lidia Niecko-Najjum

Lidia Niecko-Najjum is a counsel in Crowell & Moring’s Health Care Group and is part of the firm’s Digital Health Practice. With over 15 years of clinical, policy, and legal experience, Lidia provides strategic advice on health care regulatory and policy matters, with…

Lidia Niecko-Najjum is a counsel in Crowell & Moring’s Health Care Group and is part of the firm’s Digital Health Practice. With over 15 years of clinical, policy, and legal experience, Lidia provides strategic advice on health care regulatory and policy matters, with particular focus on artificial intelligence, machine learning, digital therapeutics, telehealth, interoperability, and privacy and security. Representative clients include health plans, health systems, academic medical centers, digital health companies, and long-term care facilities.

Lidia’s experience includes serving as a senior research and policy analyst at the Association of American Medical Colleges on the Policy, Strategy & Outreach team. Lidia also practiced as a nurse at Georgetown University Hospital in the general medicine with telemetry unit and the GI endoscopy suite, where she assisted with endoscopic procedures and administered conscious sedation.