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January 16, 2024

Health Headlines – January 16, 2023


HHS Issues New Nondiscrimination Final Rule to Protect Conscience Rights – On January 9, 2024, the HHS Office for Civil Rights (OCR) announced a final rule, entitled “Safeguarding the Rights of Conscience as Protected by Federal Statutes” (the 2024 Final Rule). The 2024 Final Rule clarifies the process for enforcing federal conscience laws and strengthens protections against conscience and religious discrimination.

Background

HHS first published a regulation implementing the Church, Coats-Snowe, and Weldon Amendments (Federal Health Care Conscience Protection Statutes) in 2008 (the 2008 Final Rule). In 2011, HHS revised the conscience rule to be narrower and handle conscience matters on a case-by-case basis (2011 Conscience Rule). In 2019, HHS finalized a sweeping revision of the conscience rule that provided broad definitions, created new compliance regulations, and set forth a new enforcement mechanism for a number of statutes related to the conscience rights of certain federally funded health care entities and providers (2019 Final Rule). On November 6, 2019, the Southern District of New York vacated the 2019 Final Rule. Shortly thereafter, the Northern District of California and the Eastern District of Washington issued similar rulings. Because the 2019 Final Rule never took effect, the 2011 Conscience Rule has been in continuous operation since it was finalized.

Summary of the 2024 Final Rule

The 2024 Final Rule does the following:

  • Clarifies that OCR is the office designated to receive, handle, and investigate complaints of the various statutes identified in the 2019 Final Rule.
  • Explains that OCR has the authority to receive, handle and investigate complaints regarding a number of provisions that protect conscience, including the Federal Health Care Conscience Protection Statutes.
  • Restores OCR’s long-standing enforcement process for the Federal Health Care Conscience Protection Statutes.
  • Describes the tools available to OCR to enforce the Federal Health Care Conscience Protection Statutes, including:
    • the authority to investigate complaints, initiate compliance reviews, conduct investigations, supervise compliance within HHS;
    • use existing enforcement regulations to achieve compliance or withhold relevant funding as authorized by the Federal Health Care Conscience Protection Statutes; and
    • in coordination with the relevant component or components of HHS, make enforcement referrals to the Department of Justice.
  • Makes clear OCR’s process for handling complaints, including:
    • Noting that anyone may file a complaint with OCR and that OCR will promptly investigate;
    • Explaining that if an investigated entity fails to respond to an OCR request for information within a reasonable timeframe and without good cause, OCR will consider that fact negatively as it evaluates all the evidence in a given case; and
    • Committing to resolving matters informally, while also clarifying OCR and the HHS’s enforcement tools to achieve compliance.
  • Encourages entities to post a notice of rights.

The effective date of the 2024 Final Rule is March 11, 2024. The 2024 Final Rule was published in the Federal Register on January 11, 2024, and may be viewed here.

The 2008 Final Rule is available here, and the 2011 Conscience Rule is available here.

Reporter, Michelle Huntsman, Houston, +1 713 751 3211, mhuntsman@kslaw.com.

King & Spalding Client Alert: New Jersey Enacts Privacy Law—On January 8, 2024, New Jersey’s State Legislature passed the Disclosure and Accountability Transparency Act (the Data Act). Following the Governor’s signature within 45 days, the Data Act will take effect one (1) year after the date of the enactment, namely January 8, 2025.  For additional insight and information about the legislation, click here to access the King & Spalding Client Alert issued by lawyers in the firm’s Data, Privacy and Security Group.