This analysis was originally published on Health Affairs Blog.
On January 19, the Trump administration proposed new regulations to interpret and enforce more than 20 federal statutory provisions related to "conscience and religious freedom." Collectively, as interpreted by the administration, these statutes would grant broad powers to individuals and organizations in the health care field and beyond to refuse to provide or be involved with services, information, and referrals to which they have religious or moral objections. That includes services related to abortion, contraception, end-of-life care, global health care assistance, vaccination, and much more. The proposed regulations and steps to enforce them have real potential to undermine existing legal and ethical protections for patients’ access to sexual and reproductive health information and services, and other critical care.
Stretching the Statutes
In proposing the new regulations (which have been described in detail elsewhere on the Health Affairs Blog), the U.S. Department of Health and Human Services (HHS) insists that it is seeking to clarify key terms in statutes that have been on the books for years—in one case, since the early 1970s. In truth, HHS is attempting to redefine many of those terms in order to expand the laws’ reach.
For example, the regulations broadly define "assist in the performance" as participating "in any program or activity with an articulable connection" to a given procedure or service. The definition goes on to include several specific examples, including "counseling, referral, training, and other arrangements," and it is so broad as to include the provision of even basic factual information. Similarly, the definition for "referral" encompasses "any information...by any method...that could provide any assistance" to someone seeking care or financing for that care.
The regulations define the actors as broadly as it does the actions. Notably, "workforce" would include not just employees, but also "volunteers, trainees, contractors...and providers holding admitting privileges." The term "health care entity" would include a wide array of individuals (not just health care professionals, but any personnel) and institutions (not just health care facilities and insurance plans, but also plan sponsors and state and local governments). A "recipient" or "sub-recipient" of federal funds may include not only United States-based entities but also "foreign or international organizations (such as agencies of the United Nations)."
Undermining Patient Protections
The clear intent of HHS’s proposed regulations is to allow individuals and institutions claiming religious and moral objections to undermine a wide range of existing patient protections.
Insurance Coverage Requirements
The HHS regulations explicitly target laws in several states (currently, California, New York, and Oregon) that require many health insurance plans to cover abortion care. HHS argues that the Obama administration misinterpreted federal law by ruling that employers sponsoring health insurance plans for their employees did not count as health care entities with conscience rights. The proposed regulations overturn that earlier guidance and add plan sponsors to the definition of "health care entities."
Along the same lines, the new refusal rule could be used to target state-level contraceptive coverage requirements. The Affordable Care Act’s (ACA’s) contraceptive coverage guarantee has famously generated dozens of lawsuits—several of which reached the U.S. Supreme Court—from employers and schools with religious objections to some or all contraceptive methods. The Trump administration expanded religious and moral exemptions to this requirement in separate rules last year (currently enjoined), but those rules did not affect state-level requirements. The proposed refusal rule could be used to undermine those state-level requirements, particularly in cases where the plan sponsor wrongly asserts that methods of contraception are actually methods of abortion.
Anti-Abortion Counseling Centers
As another example of state law purportedly violating federal conscience rights, HHS points to laws requiring antiabortion counseling centers to post factual public notices. For example, California’s Reproductive FACT Act requires facilities specializing in pregnancy-related care to post notices about the availability of public programs that provide free or subsidized family planning services, prenatal care and abortion, and for unlicensed facilities to disclose that that they do not provide medical services. By including public notices in the definition of "referral," HHS aims to prevent enforcement of these requirements and to influence ongoing court cases, including one at the U.S. Supreme Court.
Emergency Abortion Care
The HHS regulations also take issue with the idea that health care providers have obligations to patients in emergency circumstances. It criticizes an ethics opinion by the American College of Obstetricians and Gynecologists that providers have obligations to provide emergency care, as well as lawsuits brought against hospitals that refused to provide abortion-related information and care in emergency circumstances. HHS’s apparent position is that federal refusal laws are not limited by legal or ethical obligations around emergency care.
On a related note, although federal law bars federal dollars from paying for abortions under Medicaid in most circumstances, state Medicaid programs are obligated to cover abortion when a women’s life is endangered or in cases of rape or incest. States objecting to that requirement could cite the proposed refusal regulations in refusing to comply.
Counseling and Informed Consent
Less explicitly, the HHS regulations are an attack on patients’ right to have the information they need to provide informed consent to care. Health care professionals have ethical and legal responsibilities to provide that information, but the proposed refusal regulations would allow them to deny information and counseling on topics and services they find objectionable—not just on abortion and contraception, but on any topic, such as sexually transmitted infections (STI) testing and treatment, vaccination, blood transfusion, and end-of-life pain management.
As one specific example, the Title X national family planning program requires that Title X‒supported providers must offer factual information and nondirective counseling on any of the full scope of legal pregnancy options, including abortion, as well as referral for any related services upon request. In 2008, when the George W. Bush administration promulgated similar refusal regulations (which were later rescinded), HHS argued explicitly that this Title X requirement would not be enforced for organizations objecting to it, without providing any indication of how patients’ right to counseling and referral would be upheld.
The new proposed rules may also apply in the context of HHS-supported adolescent sexual health promotion programs, support services for new parents, and other social services programs that provide health-related information or referral. That could allow entities or individual instructors to withhold factual information on contraception or HIV and other STI prevention, regardless of a given federal grant program’s requirements.
Protections Against Discrimination
The proposed regulations have the potential to pit "conscience" rights against anti-discrimination policies set by federal, state and local governments, and individual employers and schools. These laws and policies vary widely, but are intended to protect patients, students and others against discrimination on the basis of a variety of characteristics, such as race, gender, sexual orientation, immigration status, disability, and HIV status. Under the proposed regulations, it is unclear whether and in what circumstances an individual or institution would be allowed to ignore those protective policies and refuse to provide information or services in a discriminatory way.
Groups representing LGBTQ individuals are particularly concerned, because of numerous complaints and lawsuits asserting that protections against discrimination on the basis of sexual orientation or gender identity are in fact violations of religious freedom. For example, HHS specifically criticizes a lawsuit brought against a health care system that denied a hysterectomy to a transgender man, despite regularly performing hysterectomies for other patients. Separately, HHS has also signaled that it will back off from protecting LGBTQ rights under Section 1557 of the ACA, the law’s sweeping anti-discrimination provision.
Impact on Employers and Programs
Currently, Title VII of the Civil Rights Act and related state laws govern religious discrimination in the workplace. Specifically, Title VII requires employers to accommodate an employee’s religious practices (such as religious refusals), unless doing so would impose an undue hardship on the employer—something that, in the health care field, would include practices that undermine patient care. The proposed refusal regulations ignore this legal standard and the balance that it attempts to strike. Without that balance, health care institutions and public programs could be forced accommodate employees who refuse to perform central functions of their job or seek to discriminate against patients. For example, family planning clinics might be forced to employ individuals unwilling to provide, discuss or even schedule appointments for contraception.
Impact Beyond The United States
The proposed regulations may pose particular problems for international, foreign and multilateral organizations. The regulations apply long-standing United States conscience laws to organizations outside of the United States in cases where United States funding is administered by HHS, and in doing so, HHS does not appear to be giving any deference to existing federal law governing United States foreign policy, nor to the agencies entrusted to set this policy. This might create confusion among federal agencies about which laws to follow, generate conflict with policies promulgated by the Departments of State and Defense and the United States Agency for International Development, and lead to unforeseen foreign policy complications. Moreover, it is unclear how large international agencies, such as the World Health Organization or the Global Fund to Fight AIDS, Tuberculosis and Malaria, could require, monitor and certify compliance by their numerous local sub-grantees, particularly in cases where United States "conscience" laws conflict with the laws of other countries. This has the potential to force such international agencies out of HHS-administered programs altogether.
Expanding Enforcement
Responsibility for interpreting, monitoring, and enforcing these proposed regulations is placed on the shoulders of a new branch of the HHS Office for Civil Rights (OCR). That new "conscience and religious freedom" division was announced in a high-profile event the day before the new regulations were proposed, with Trump administration officials, members of Congress, and conservative activists denouncing what they called rising intrusion into conscience rights. The announcement builds on promises by candidate and President Donald Trump, including a May 2017 executive order on "free speech and religious liberty."
Under the proposed regulations, the new division would have substantial powers. The regulations would take enforcement authority that OCR has used for traditional civil rights laws and apply them to federal conscience laws. Beyond its existing powers to receive and investigate specific complaints, OCR would be able to require public notices, demand access to records, conduct periodic compliance reviews, initiate investigations without specific complaints, refer cases to the Department of Justice, and force compliance by withholding or suspending federal funding.
A public comment period for the proposed regulations is open through March 27. Similar regulations put forth at the end of the George W. Bush administration in 2008 generated more than 200,000 public comments, with opposition from a long list of medical associations, civil and human rights groups, reproductive rights organizations, public officials and others (including the Guttmacher Institute). After those regulations were finalized, they were immediately challenged in court and then rescinded almost entirely during the Obama administration. It seems likely that these proposed regulations will also generate substantial public comment and debate—and they should, because the potential consequences are profound for sexual and reproductive health and rights, and beyond.