Status Check On Federal Executive Action On Abortion Access

It has been three weeks since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, which rejected nearly 50 years of precedent in holding that women (and other people who can become pregnant) no longer have a constitutionally protected right to a pre-viability abortion. Dobbs paved the way for states to outlaw or further restrict abortion, leading to a severe patchwork of rights and protections that will vary by state.

The decision—and questions about the legality, scope, and enforcement of various state restrictions—has led to significant uncertainty for health care providers, patients, employers, insurers, and advocates. More bans and restrictions are likely coming during the next state legislative cycle, aided by even more draconian model laws being developed by anti-abortion organizations.

Amid this uncertainty, the Biden administration has been under significant pressure to leverage executive authority in preserving access to reproductive services. To date, the White House has made initial commitments and issued an executive order. And federal agencies, especially the Department of Health and Human Services (HHS), have issued guidance on patient privacy, emergency care, contraceptive coverage, pharmacy obligations, and sick leave for travel for federal employees. HHS will also distribute new funding for Title X family planning providers and has launched a public awareness website. This article summarizes much of this new guidance and activity.

As discussed below, federal officials are prioritizing the need to provide at least some clarity for health care providers on their obligations to provide care and protect patient information under federal law. States have already begun to push back: On July 14, Texas sued over the emergency care guidance. Even so, additional policies are expected over time in response to President Biden’s executive order. And some stakeholders, such as the Business Group on Health, have requested additional clarity on specific issues to help employers and plans navigate this new reality while maintaining coverage for employees.

It is worth emphasizing that federal officials have limited options, on their own, to ensure access to abortion. Critics have called for bold executive action in response to Dobbs. But existing federal restrictions, such as the Hyde Amendment, have long limited the federal government’s role in abortion access. Federal action is critical, but long-standing federal restrictions make it impossible to fully fill the gap left by Dobbs. Federal administrative policy alone will not go as far as what women in much of the country need—with devastating consequences.

Initial Focus: Right To Travel And Access FDA-Approved Medication

In conjunction with remarks from President Biden after Dobbs was issued on June 24, the White House released a short fact sheet highlighting two primary commitments. First, the White House pledged to safeguard the right to travel safely to obtain care. Dobbs, the White House emphasized, does not prevent a woman from traveling from a state that restricts abortion to a state that allows it. The Biden administration intends to fight any effort by state or local officials that attempts to restrict travel.

Second, President Biden directed HHS to protect access to medications approved by the Food and Drug Administration (FDA) for reproductive health care, including drugs used for medication abortion, miscarriage management, and contraception. This effort will be especially important in light of attempts by state officials to ban or severely restrict access to FDA-approved drugs. In particular, the White House directed HHS to identify ways to ensure that mifepristone—which has been approved by the FDA as safe and effective since 2000—is widely accessible, including through telehealth and by mail.

These same priorities—ensuring safe travel and access to FDA-approved medications—were echoed in a separate statement from Attorney General Garland. Under “bedrock constitutional principles,” women must remain free to travel—and individuals can inform and counsel one another about care available in other states. He also warned that violence and threats of violence will not be tolerated and are not protected by the First Amendment. On medication abortion, the FDA has the full support of the Department of Justice (DOJ), and states cannot ban mifepristone because they disagree with FDA’s judgment about the drug’s safety and efficacy.

Beyond these issues, the DOJ will continue to enforce the Freedom of Access to Clinic Entrances Act, which prohibits individuals from obstructing, injuring, intimidating, or interfering with access to reproductive health services. And federal agencies and employees can continue to provide reproductive health services consistent with federal law and without the threat of criminal or civil liability under state law or the Assimilative Crimes Act.

Executive Order Directs Additional Action And Consideration

On July 8, President Biden signed an executive order designed to further bolster access to reproductive health services, including abortion. The executive order defines reproductive health services broadly and refers to medical, surgical, counseling, or referral services, including services for pregnancy or the termination of a pregnancy. The executive order was accompanied by a fact sheet.

Executive orders cannot change existing law but can direct federal agencies to draft new rules or guidance consistent with the administration’s existing legal authority. How quickly an executive order can be implemented depends on the underlying policy that is being directed. Changes that are largely operational, such as outreach and public education, can be made swiftly while changes that require new rules or revisions to existing rules require notice-and-comment rulemaking processes that take months.

The executive order directs HHS to prepare a report within 30 days that identifies ways to protect and expand access to the full range of reproductive health services—with a specific mention of medication abortion and emergency contraception. HHS is also tasked with improved outreach and education, which could include a public awareness initiative with timely information about patients’ legal rights and assistance under federal programs (such as Title X clinics). The executive order also discusses the need to provide emergency medical care to those experiencing pregnancy loss and protect sensitive health information. Some of these priorities are discussed below.

Separately, the DOJ will convene volunteer lawyers to help represent those who face civil and criminal lawsuits and, jointly with the Department of Homeland Security, consider ways to ensure the safety of health care facilities. The DOJ already established a Reproductive Rights Task Force to help monitor and evaluate state and local actions related to reproductive care, travel, accurate information, medication abortion, and federal employees. And the Federal Trade Commission, alongside HHS and the DOJ, is directed to consider ways to protect consumers from privacy violations and fraudulent and deceptive practices when seeking information about reproductive health services. The Federal Trade Commission already announced it will fully enforce federal law to help safeguard consumers’ privacy, prevent the misuse of data, and promote accurate information.

These collective efforts will be coordinated by a newly established Interagency Task Force on Reproductive Healthcare Access that will be co-chaired by the HHS Secretary and the Director of the Gender Policy Council. Funding and administrative support will be provided by HHS, and the Attorney General will provide technical assistance on constitutional issues, such as the right to travel.

HHS Clarifies Federal Provider Obligations Under HIPAA, EMTALA, Section 1557

Providers face significant uncertainty in providing reproductive services in the wake of Dobbs. This is because many current state bans are broad and vague, making it unclear as to whether and how providers might be civilly or criminally penalized for providing care. This uncertainty has already had a chilling effect as physicians, clinics, pharmacies, and other providers have stopped providing a range of services or medications for fear of prosecution, civil penalties, or the loss of their medical license.

At the same time, health care providers must comply with federal laws and regulations that can apply to the same types of services being outlawed or restricted by states. In general, federal requirements preempt (and thus supersede) state laws. To date, HHS has issued guidance to clarify provider obligations under federal laws that govern patient privacy, emergency treatment, and civil rights.

HIPAA Obligations For Patient Privacy

On June 29, the HHS Office for Civil Rights (OCR) issued new guidance to clarify expectations for protecting patient health information and privacy under the Health Insurance Portability and Accountability Act (HIPAA). HIPAA requires health care providers, health plans, and other covered entities and business associates to protect sensitive patient health information from being disclosed without a patient’s consent or knowledge except in limited circumstances.

Why does this matter post-Dobbs? Because state and local prosecutors or other law enforcement officials might ask for sensitive patient information from hospitals and providers and attempt to use this information to prosecute or sue providers or other parties. Alternatively, some health care workers may want to report patient information to law enforcement under state civil or criminal laws.

Overall, OCR’s new guidance cautions covered entities against voluntarily reporting protected health information to state authorities except in the narrowest of circumstances and only when truly compelled to comply with a legally enforceable requirement. Providers who are concerned about their reporting obligations should seek legal advice. OCR encourages individuals to file a complaint with OCR if there has been a violation of a patient’s health privacy rights.

Note that HIPAA protections generally do not extend to health information stored on your own cell phone or tablet or within apps, browsers, or search engines. This is because these devices or tools are generally not held by covered entities, meaning HIPAA does not apply. As a result, your internet search history and any information you download or enter into mobile apps is not protected by HIPAA. Neither is any geolocation data from your phone or information that you voluntarily share online. OCR issued separate guidance that explains this distinction and highlights best practices for keeping this information as secure as possible and improving patient privacy and security on phones and tablets.

Required By Law Exception

HIPAA prevents the disclosure of information except in limited circumstances. One of these limited circumstances is when disclosure is required under another law. This “required by law” exception is narrow, meaning disclosure is permissible only in response to “a mandate contained in law that compels an entity to make a use or disclosure of PHI and that is enforceable in a court of law.” Examples outlined in federal regulations include court orders, subpoenas, lawsuits, or statutes or regulations that require the production of this information. The scope of disclosure is also narrow and should be limited to the law’s specific requirements and tailored to protect the patient’s privacy. OCR also emphasizes that covered entities are permitted (not required) to disclose patient information without their consent.

OCR’s new guidance affirms that health care providers, plans, and other covered entities cannot disclose protected health information related to abortion and reproductive health services without a patient’s consent unless the request for the information is truly “required by law.” That means the request is accompanied by a mandate enforceable in a court of law pursuant to a state requirement that explicitly (not generally) requires covered entities to disclose information about patients. In the absence of these requirements, covered entities are barred under HIPAA from disclosing patient information.

The guidance includes examples to help illustrate these concepts. For instance, a health care worker who suspects that a patient in the emergency room tried to terminate her pregnancy cannot disclose this suspicion or other information unless a state law expressly requires this information to be reported. In another example, clinics cannot hand over abortion-related records to a law enforcement officer unless the request is accompanied by a court or order or some other enforceable requirement. Even with a court order, the clinic is permitted (not required) to disclose the requested information; even then, the clinic’s disclosure must be limited to the information expressly authorized by the court order.

Serious Threat To Health Or Safety Exception

OCR also addresses a separate exception under HIPAA that permits a covered entity to disclose patient information if disclosure is believed, in good faith, to be necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public. This exception, OCR explains, does not automatically permit the disclosure of abortion-related protected health information. If, for instance, a pregnant patient told their provider that they intend to travel to and obtain care in a state where abortion is legal, the provider cannot disclose this information to law enforcement. This is because 1) the patient’s statement about their intent to obtain a legal abortion does not qualify as a serious and imminent threat to health and safety; and 2) the disclosure would compromise the patient/physician relationship in a way that is inconsistent with professional ethical standards.

EMTALA Obligations For Emergency Care At Hospitals

On July 11, HHS issued new guidance to clarify provider obligations to provide emergency care under the Emergency Medical Treatment and Active Labor Act (EMTALA). The new guidance was released alongside a letter to providers which affirmed that EMTALA protects the clinical judgment of frontline health care workers and their ability to fulfill their professional and legal duty to provide stabilizing medical treatment to patients, regardless of state restrictions.

Overall, if a physician concludes that a pregnant patient is experiencing an emergency medical condition under EMTALA—and that abortion is the stabilizing treatment necessary to resolve that condition—the hospital and physician have an obligation to provide that treatment. Treatment should be provided irrespective of any state laws or mandates that apply to specific procedures, such as abortion.

Note that this is not a new requirement. The new guidance builds on similar guidance issued in September 2021 after the Supreme Court allowed Texas to ban abortions after six weeks of pregnancy. Other long-standing guidance on EMTALA can be found here.

EMTALA Requirements

Under EMTALA, hospitals that receive Medicare funds must provide emergency room patients with an appropriate medical screening and examination and provide stabilizing treatment to any individual with an emergency medical condition. Hospitals are barred from transferring or turning away a patient unless the individual is stabilized, requests the transfer, or the medical benefits of transfer outweigh the risks.

EMTALA defines an “emergency medical condition” to include medical conditions with acute symptoms of sufficient severity that, in the absence of immediate medical attention, could put the patient’s health in serious jeopardy, or result in a serious impairment to bodily functions or serious dysfunction of any bodily organ or part. There is a provision specific to pregnant women: an emergency medical condition exists if a woman who is having contractions does not have enough time for a safe transfer to another hospital before delivery, or if the transfer might pose a threat to the “health or safety of the woman or the unborn child.”

The guidance confirms that physicians and medical personnel are responsible for determining whether there is an emergency medical condition which may include, but is not limited to, ectopic pregnancy, complications of pregnancy loss, or emergent hypertensive disorders, such as preeclampsia with severe features. Stabilizing treatment under EMTALA could include medical and/or surgical interventions, including abortion, methotrexate therapy, or anti-hypertensive therapy. HHS also suggests that EMTALA’s screening requirement applies to areas of a hospital that meet the definition of a “dedicated emergency department.” Because labor and delivery units could satisfy this definition, patients in this unit may need to be screened under EMTALA.

HHS separately invokes conditions of participation in the Medicare program to underscore that hospitals are required to provide appropriate care to admitted patients. HHS points to requirements for ensuring that medical staff are accountable for the quality of patient care and appropriate discharge planning. These provisions extend to all patients, not just those in the emergency room.

Preemption Of State Laws

EMTALA preempts state laws where the state’s exception for the life of the patient is narrower than EMTALA’s definition of an emergency medical condition. EMTALA would also preempt any state abortion bans without an exception for the health or life of the mother, although all current state bans include such an exception. Hospitals also cannot cite the fear of violating state law or practice as the reason for transferring a patient.

Enforcement

HHS intends to enforce EMTALA in response to complaints (which can be filed here) and will investigate a hospital’s policies, procedures, and process in addition to the actions of medical personnel. Hospitals and physicians that violate EMTALA may lose the ability to participate in the Medicare program or face civil monetary penalties. Patients who are harmed by the failure to comply with EMTALA could sue the hospital or physician. Physicians could also raise EMTALA as a defense to any attempt by a state to enforce an abortion ban or in response to being disciplined for refusing to transfer an individual without providing stabilizing treatment. (As with the pharmacy guidance below, federal conscience protections apply to individual health care workers who object to providing care; complaints related to these laws will be investigated on a case-by-case basis.)

Litigation

On July 14, the attorney general of Texas sued HHS over the EMTALA guidance. The lawsuit, filed in the Lubbock division of the northern district of Texas, argues that HHS does not have the legal authority to clarify EMTALA, that federal officials should have provided notice and an opportunity for public comment before issuing the guidance, and that HHS failed to sufficiently justify its guidance. Texas also asserts that the guidance is unconstitutional under the Spending Clause, nondelegation doctrine, and Tenth Amendment. The complaint unsurprisingly invokes the “major questions” doctrine and cites West Virginia v. Environmental Protection Agency to argue that HHS exceeds its authority by weighing in on the question of abortion.

This article does not provide a full summary or assessment of the lawsuit. But it is not even clear how the guidance conflicts with Texas law since Texas’ abortion laws (both civil and criminal) explicitly allow an abortion to protect the life of the mother. Texas never explains why HHS’s guidance—which merely requires stabilizing treatment in response to an emergency medical condition—automatically preempts these state laws or hospital practices. It is true that, per the guidance, EMTALA preempts any state laws that are narrower in scope. But Texas does not bother being precise about how and why a conflict might arise. Instead, Texas asserts that, under the guidance, hospitals will be required to provide abortions when the life of the mother is not in danger (which is not the case).

Civil Rights Obligations For Pharmacies Under Section 1557 And Section 504

On July 13, HHS OCR issued new guidance to clarify the obligations of pharmacies under health care civil rights protections. These clarifications are important to address confusion about what can (or cannot) be prescribed under various states laws and because pharmacies often play a key role in promoting reproductive health services (by dispensing contraception, medication for abortion, medication for miscarriage management, and more).

Pharmacies receive federal financial assistance (such as Medicare or Medicaid payments) and so must comply with federal nondiscrimination provisions, such as Section 1557 of the Affordable Care Act and Section 504 of the Rehabilitation Act. Section 1557 prohibits discrimination based on sex (among other bases) by any health program or activity. Per OCR, sex discrimination under Section 1557 includes discrimination on the basis of pregnancy or related conditions. Discrimination on the basis of pregnancy includes discrimination based on a current pregnancy, a past pregnancy, a potential or intended pregnancy, and medical conditions related to pregnancy or childbirth. Pharmacies must also comply with Section 504, which prohibits discrimination based on disability. Though pregnancy itself is not a disability, medical issues resulting from pregnancy can qualify as a disability for purposes of Section 504.

OCR includes eight examples to help pharmacies understand their obligations under these laws. For instance, a pharmacy may violate Section 1557 or Section 504 by refusing to stock or fill a prescription if the pharmacy refuses to do so because that drug can be used to terminate a pregnancy. Further, a pharmacy may be discriminating on the basis of sex if it refuses to fill a prescription for mifepristone and misoprostol that is ordered for miscarriage management. Ditto if a pharmacy refuses to fill a prescription for methotrexate to address an ectopic pregnancy or rheumatoid arthritis—or misoprostol to treat a patient’s stomach ulcers—because these drugs can be used to terminate a pregnancy.

OCR’s examples focus on the pharmacy itself and do not address the actions or prescribing activities of individual pharmacists, some of whom may have personal objections to the care noted above. OCR’s guidance acknowledges the Church Amendments, which prohibit employment-related discrimination against those that refuse to perform or assist in a lawful sterilization procedure or abortion because of religious beliefs or moral convictions. OCR does not provide additional detail, noting only that the Church Amendments will be evaluated and applied on a case-by-case basis.

Tri-Agencies Clarify Contraceptive Coverage Requirements

On June 27, HHS, the Department of Labor, and the Department of Treasury issued a letter to group health plans and insurers to remind them of their obligations to cover the full range of contraceptives under the Affordable Care Act. Consistent with guidance issued in January 2022, the agencies reminded plans and insurers to provide access to the full range of FDA-approved contraceptive methods as prescribed by a health care provider.

The most recent letter was issued after Dobbs and in response to continued concerns—documented by the media, advocacy organizations, and in letters from members of Congress—that plans and insurers are limiting access to, or imposing cost sharing for, a range of FDA-approved contraceptives and may not be in compliance with federal standards.

The letter does not appear to adopt any new standards. But the agencies strongly encourage compliance with existing standards and emphasize the need for improved compliance regarding accessible, transparent, and expedient “exceptions” processes. Plans and insurers should review their processes, develop standard forms and instructions, and ensure that the exceptions process is clearly described for enrollees. The letter also emphasizes the need to defer to providers’ judgment and eliminate overly burdensome and unreasonable medical management techniques.