On May 21, 2019, the Federal Register published the U.S. Department of Health and Human Services’ (HHS) final rule titled Protecting Statutory Conscience Rights in Health Care (Conscience Rule), which addresses the rights of individual healthcare employees who object to participating in medical procedures that violate their consciences, as well as the rights of faith-based healthcare institutions to provide services consistent with their religious mission and identity. The rule was challenged in two suits filed in federal courts in New York and California, one by the New York State attorney general and joined by 22 other states and the other by the California attorney general. The suits allege that the rule would impede access to basic and emergency healthcare and encourages discrimination against women; lesbian, gay, bisexual, and transgender individuals; and other patient populations. HHS has indicated its intent to vigorously defend the rule. If not stayed by a federal court, the Conscience Rule will take effect on July 22, 2019.

The Conscience Rule was issued following a 60-day comment period ending in March 2018, during which HHS received over 240,000 comments on an earlier version of the rule. In a statement issued on May 2, 2019, HHS’s Office for Civil Rights (OCR) explained that it considered it necessary to revise existing regulations due to substantial growth in conscience-related complaints and inadequate enforcement of conscience rights under existing federal laws, as well as a lack of knowledge of rights and obligations under HHS-funded or administered programs.

Core Provisions of the Conscience Rule

 The Conscience Rule adds or enhances enforcement mechanisms for approximately 25 federal conscience protection and anti-discrimination laws and federal programs, including the Patient Protection and Affordable Care Act, the Public Health Service Act, the Church Amendments (42 U.S.C. § 300a-7), the Coats-Snowe Amendment (Section 245 of the Public Health Service Act, 42 U.S.C. § 238n), the Weldon Amendment to HHS’s annual appropriations acts, and certain programs administered by HHS, including Medicare Advantage, Medicaid, and global health programs.

Entitles covered by the rule include federal agencies and programs, state and local governments receiving federal funds, and certain federally funded entities. Because the rule implements provisions of numerous federal laws, its application to a particular entity may vary depending on the law at issue. Covered entities may include public and private health providers that receive HHS funds, universities and schools that provide healthcare training, and individuals and entities that receive funding from HHS or through particular programs administered by HHS for healthcare services, insurance, provider licensing, and research.

In general, the Conscience Rule provides and implements protections for the following individuals and entities:

• Healthcare entities and employees that have conscience or religious objections to performing, paying for, referring for, providing coverage of, or providing certain services, such as abortion, sterilization, or assisted suicide, or providing or receiving training in abortion

• Healthcare professionals who decline to receive training in abortion or who attend medical schools that do not require abortion training, and applicants for training or study who have conscience or religious objections to assisting, recommending, or referring for abortion or sterilization

• Individuals in a health service or research activity funded by an HHS program who decline to perform or assist in part of that program because of religious beliefs or moral convictions

• Patients, including parents who object to certain procedures such as screenings and mental health treatment of children

Certain applicants for and recipients of federal funds also would be required under the rule, as condition of receipt or extension of such funds, to submit assurances and certifications to HHS that they are in compliance with applicable federal laws covered by the rule, to keep records to establish such compliance for at least three years, to cooperate with OCR’s enforcement activities, and to not retaliate against anyone who files a complaint with OCR alleging a violation of any federal conscience law or cooperates with OCR’s investigations of such complaints.

The rule empowers OCR to receive and investigate complaints of violations of conscience rights, to initiate compliance reviews, to request information in connection with investigations, to make referrals to the Department of Justice in coordination with HHS’s Office of the General Counsel, and to withhold, temporarily suspend, or deny federal funds or financial assistance to remediate the effects of discrimination.

The rule encourages but does not require recipients of HHS funds to post notices of conscience rights or otherwise inform patients, students, and/or employees of such rights. The rule provides that, in investigating a complaint or conducting a compliance review, OCR will consider an entity’s voluntary posting of such a notice on its premises or website and/or in its employee or student handbook as nondispositive evidence of compliance with applicable provisions of the rule.