The U.S. Department of Health and Human Services (HHS) has published a Final Rule that aims to strengthen protections for health care providers against having to provide services that violate their conscience, such as abortion, sterilization and assisted suicide.

Issued on May 2, 2019 and effective 60 days from when it is published in the Federal Register, the rule is titled "Protecting Statutory Conscience Rights in Health Care; Delegations of Authority." It clarifies which entities must comply with conscience provisions and details their obligations to document compliance, cooperate with the OCR and maintain non-retaliation requirements.

The regulations outlined in the 440-page Final Rule are far reaching and all inclusive, protecting individuals who are employed by covered entities and who do not want to provide health care services or assist in the provision of health care services to which the individual has a moral or religious objection. It is unclear at this time how broadly the regulations will be interpreted, and at least one court challenge is already underway. 

Covered Entities

While many different entities are specified throughout the regulation, in general, the rule requires that entities that receive any federal funds as well as States and local governments apply the protections listed in the regulations.

Protected Entities

Protected under the regulations are: health care providers, non-health care providers who work for covered employers and offer health care services or those non-health care providers who could see their work as assisting in the performance of the provision of objected-to services.

Parents are also specifically protected by the regulations, which incorporate four statutory provisions that allow parents to, on the basis of conscience, object to their children receiving certain treatments or health interventions.

Covered Services

The most frequently referenced services are sterilization procedures, abortions and assisted suicides. However, there is also general language in the regulation noting that it pertains to “any” health service or research activity.

In certain circumstances, parents can also object to the following services being provided to their children:

• Suicide assessment, early intervention, or treatment services;
• Hearing loss screening for newborn, infants or young children;
• Vaccinations; and
• Any medical service or treatment against the religious beliefs of that parent or legal guardian.

Compliance Obligations for Covered Entities

Every application for federal financial assistance or federal funds shall – as a condition of approval, renewal or extension – provide, contain or be accompanied by a certification that the applicant or recipient will comply with applicable federal conscience and anti-discrimination laws.

Providers who already receive federal funds will submit their certifications of assurances when they re-apply or re-certify, while more frequent assurance may be required if it is determined that an entity has violated these regulations or if the OCR or Department of Justice suspects a violation.

Complete and accurate records must be kept to evidence compliance with federal conscience and anti-discrimination laws for three years. These records will be provided to the OCR, upon request, and should include:

• Complaints and resulting investigations;
• Statements, policies or notices and procedures for accommodating employees; and
• Records of requests for religious or moral accommodation, and the recipient’s response.

Recommended Steps to Demonstrate Compliance

The Conscience Rule regulations provide that the following actions may help demonstrate a provider’s compliance with the regulations:

• Providing notice to individuals and entities about their right to freedom from coercion or discrimination on account of religious beliefs or moral convictions.
• Voluntary posting of a notice of non-discrimination on websites, in personnel manuals or similar documents.
  • A sample notice of non-discrimination is included in the regulation. 

Penalties for Noncompliance

If a violation is determined to exist, the OCR can:

• Temporarily withhold federal funds;
• Deny use of federal funds;
• Terminate federal funding;
• Deny or withhold new federal funding;
• Refer a complaint to the Attorney General; and
• Pursue other legal remedies.

Looking Ahead

A lawsuit has already been filed by the City of San Francisco against HHS alleging that the rule would allow providers to deny any care to lesbian, gay, bisexual and transgender individuals. Additional lawsuits can be expected and the results of those lawsuits may provide an additional framework for the regulation's interpretation.