Following the US Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, the federal government has issued various guidance to healthcare providers reinforcing federal legal protections or requirements related to abortion services. Healthcare providers must vigilantly follow developments at both the federal and state level to evaluate their compliance strategies in this rapidly evolving regulatory landscape.
Recent federal guidance in the reproductive rights arena includes agency guidance regarding pharmacies and the dispensing of medication that can be used as abortifacients, health data privacy, and hospital emergency departments’ obligations to screen and stabilize patients in emergency situations.
The government also launched REPRODUCTIVERIGHTS.GOV to serve as a public resource about these federally established reproductive rights, including specific links to resources on the Affordable Care Act’s coverage requirements for birth control as well as information on coverage and funding (and its limitations) for abortions.
This federal guidance has been issued against the backdrop of a flurry of state activity, including activation of a number of state “trigger” provisions post-Dobbs, litigation regarding these laws, and letters from state legislators promising the introduction of bills restricting abortion access further, including restrictions on coverage of telehealth services for abortion as well as the use of abortion-related medication. Most recently, the state of Texas filed a lawsuit challenging the Biden-Harris administration’s guidance related to the application of the Emergency Medical Treatment and Labor Act (EMTALA), arguing it violates the state’s “sovereign interest in the power to create and enforce a legal code.”
The Biden-Harris administration announced that it intends to protect the right to seek medical care and the right to access medications for reproductive healthcare—including pharmaceutical abortions—to the extent permitted by law. Per the US Department of Health and Human Services (HHS) website:
Medication abortion has been approved by the FDA since 2000 as a safe and effective option. Federal regulation permits medication abortion to be dispensed by telehealth and sent by mail via certified prescribers and pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.
Exercising its authority to regulate pharmacies and pharmacists that accept federal healthcare program funding such as Medicare and Medicaid, HHS issued guidance to roughly 60,000 US retail pharmacies on July 13.
This guidance reminds pharmacies and pharmacists that as recipients of federal financial assistance, they are prohibited from discriminating against pharmacy customers on the bases prohibited by Section 1557 of the Affordable Care Act and Section 504 of the Rehabilitation Act, including with regard to supplying medications; making determinations regarding the suitability of a prescribed medication for a patient; or advising patients about medications and how to take them.
All of the examples in the guidance cover situations in which a doctor can still legally prescribe the medication cited, even in states that restrict access to abortifacients. They include situations such as
None of the specific examples above require a pharmacy to fill a prescription for abortion medication when the prescription is for the purpose of inducing an unlawful abortion.
This guidance serves as an HHS Office of Civil Rights (OCR) warning to pharmacies that they cannot refuse to stock medication or refuse a lawful prescription due to fears about the potential for the medicine being used for unlawful means. The guidance is based on the fact that those actions could constitute discrimination on the basis of sex or disability because they amount to a refusal of lawful treatment tied to specific medical conditions and, in the case of pregnancy, gender.
HHS’s July 13 guidance notes that the Church Amendments at 42 U.S.C. § 300a-7 protect healthcare personnel from discrimination related to their employment because they performed or assisted in the performance of abortion or sterilization. While the guidance does not address how the Church Amendments would apply in a given case, HHS stated that the OCR will evaluate and apply the Church Amendments on a case-by-case basis.
The Federal Trade Commission has expressed concerns regarding consumer-generated health information not protected under the Health Insurance Portability and Accountability Act (HIPAA) such as data collected by many mobile health apps.
The collection of geolocation data by search engines and other tech companies raises concerns post-Dobbs. Geolocation data could be used to identify whether an individual has visited an abortion clinic or crossed state lines to obtain an abortion, and might be sought by state law enforcement authorities.
In response to some of these concerns, the Biden-Harris administration released new patient-privacy guidance in an effort to clarify where federal protections around personal medical information can protect the requests for abortion-related information from law enforcement officials. The guidance documents were issued June 29 by the OCR and seek to address how federal law and regulations protect individuals’ private medical information relating to abortion and other sexual and reproductive healthcare, “making it clear that providers are not required to disclose private medical information to third parties.”
The OCR guidance also provides tips on how to protect personal information when using apps like period trackers and other health information apps, since the HIPAA Privacy, Security, and Breach Notification Rules generally do not apply to individuals’ health information when it is collected through direct-to-consumer apps and other digital heath products. There are concerns this information could be subject to warrants and subpoenas by prosecutors seeking user data to document out-of-state travel.
EMTALA applies to the obligations of hospital emergency departments to screen and stabilize patients in emergency situations, regardless of a patient’s ability to pay. On July 11, HHS Secretary Xavier Becerra announced an update to the agency’s EMTALA guidance, explaining the government’s position on the supremacy of EMTALA over state law:
Fear of violating state law through the transfer of the patient cannot prevent the physician from effectuating the transfer nor can the physician be shielded from liability for erroneously complying with state laws that prohibit services such as abortion or transfer of a patient for an abortion when the original hospital does not have the capacity to provide such services. When a direct conflict occurs between EMTALA and a state law, EMTALA must be followed.[1]
This document also adds new guidance concerning the “stabilizing treatment” required for patients who have an emergency medical condition as defined by EMTALA. HHS restates its previously adopted regulatory definition of “stabilized” in 42 CFR 489.24(b) before noting the following:
The course of stabilizing treatment is under the purview of the physician or qualified medical personnel. If qualified medical personnel determine that the patient’s condition, such as an ectopic pregnancy, requires stabilizing treatment to prevent serious jeopardy to the patient’s health (including a serious impairment or dysfunction of bodily functions or any bodily organ or a threat to life), the qualified medical personnel is required by EMTALA to provide the treatment.
While emphasizing the agency’s expectations of physicians and hospitals under EMTALA and reminding them of its enforcement authority (i.e., civil monetary penalties of up to $119,942 per violation for hospitals over 100 beds and physicians), HHS also sought to offer its aegis to those subject to its guidance. The July EMTALA guidance provides the following:
Any state actions against a physician who provides an abortion in order to stabilize an emergency medical condition in a pregnant individual presenting to the hospital would be preempted by the federal EMTALA statute due to the direct conflict with the “stabilized” provision of the statute.
Secretary Becerra’s letter accompanying the new guidance further suggests that “a state law that prohibits abortion and does not include an exception for the life and health of the pregnant person—or draws the exception more narrowly than EMTALA’s emergency medical condition definition—that state law is preempted.” (Emphasis added)
Some of the states where “trigger laws” went into effect based on Dobbs (e.g., Texas) contain exceptions only for “the purpose of saving the life of the mother.”[2] If applied as the HHS secretary suggests, this new Biden-Harris administration guidance, which applies in the hospital emergency room context, would attempt to use federal preemption to broaden situations where abortions may be performed in states with the most abortion-restrictive laws.
To what extent the agency’s guidance relating to its regulatory requirement for EMTALA stabilizing treatment can preempt state criminal laws limiting the circumstances in which abortions may be performed is an issue that will ultimately be sorted out by the courts.
This question may be addressed sooner rather than later, as the Texas attorney general on July 14 filed a lawsuit in federal district court in Lubbock, Texas seeking to enjoin the Biden-Harris administration from implementing the July 11 EMTALA Update in Texas. While the Texas attorney general’s complaint may overstate the scope of the updated EMTALA guidance for effect (e.g., asserting it as an attempt to “transform every emergency room in the country into a walk-in abortion clinic”), the complaint does place the question of preemption squarely before the court.
Regardless of the complexities it presents and the legal challenge it faces in Texas, the July EMTALA guidance does attempt to expand access to abortion for certain emergency medical conditions.
Both the federal guidance and state legal reactions add complex legal considerations that must be calculated by hospitals and physicians caught in the middle of what may be a complicated preemption fight. The extent to which federal law will preempt state laws that restrict access to abortion will be hotly contested. Healthcare providers should consult with counsel as they navigate this rapidly evolving legal landscape.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:
Washington DC
Tesch Leigh West
Sharon Perley Masling
Howard J. Young
Houston
Gregory N. Etzel
[1] HHS Reinforcement of EMTALA Obligations Specific to Patients who are Pregnant or are Experiencing Pregnancy Loss (QSO-21-22-Hospitals UPDATED July 2022).
[2] See Art. 4512.6 West’s Texas Statutes.