Final Rule Governing Healthcare Conscience Protections Is Now in Effect

Apr 23, 2024 at 10:47 am by kbarrettalley


By Tamra Harris and Nina Wall

Holland & Knight

 

Earlier this year, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) published its 2024 Final Rule governing healthcare conscience protections, “Safeguarding the Rights of Conscience as Protected by Federal Statutes.” The Final Rule dictates the protections and enforcement procedures surrounding the rights of healthcare providers and entities to be free from discrimination associated with their decisions to participate or refrain from participating in procedures based on their conscience. The 2024 Final Rule took effect March 11, 2024.

Background

The conscience protections are statutorily authorized under the “Church Amendments” and the “Coats-Snowe Amendment,” which provide different, but related, protections. The Church Amendments prohibit public officials and authorities from imposing certain requirements that run contrary to a person’s or entity’s religious beliefs or moral convictions pertaining to abortion, sterilization and other healthcare services involving certain federal funds. The Coats-Snowe Amendment provides conscience protections for healthcare entities related to abortion provision or training, referrals for such abortion or training, and accreditation standards related to abortion. These protections are also implicated under Medicare and Medicaid statutes, the Weldon Amendment and provisions included in the Affordable Care Act (collectively, the “federal healthcare conscience protection statutes”).

HHS first authorized rulemaking associated with the conscience protections in 2008; however, it quickly determined that the regulations were overbroad, and new regulatory requirements were published in 2011. The 2011 Final Rule eliminated some of the specific definitions and processes articulated in the 2008 Final Rule, but retained provisions designating OCR as the recipient for complaints of violations of the conscience protections. In 2018, HHS once again issued a Proposed Rule aiming to reinstate some of the 2008 Final Rule’s provisions. That updated Final Rule, adopted in 2019, included specific definitions for relevant terms, imposed procedural requirements and detailed enforcement procedures. The 2019 Final Rule has been the subject of multiple challenges, and multiple district courts have declared it impermissible. As such, HHS has been operating under the 2011 Final Rule since its publishing.

So, Where Are We Now?

The 2024 Final Rule delegates authority to OCR to initiate compliance reviews; conduct investigations; utilize existing enforcement regulations (and withhold funding) for grants, contracts and other programs and services; and make enforcement referrals to the U.S. Department of Justice. Any individual or entity may file a complaint with OCR alleging potential violations of the federal healthcare conscience protection statutes. In other words, the complainant is not required to be the entity whose rights have been violated. Failure to respond to a request for information or to a data or document request will result in a negative inference.

One best practice for achieving compliance with and educating the public on the 2024 Final Rule is by posting and providing notice about the federal healthcare conscience protection statutes. The 2024 Final Rule outlines a model notice in Appendix A, which states, in part:

“You may have rights as a provider, patient, or other individual under these Federal statutes, which prohibit coercion or other discrimination on the basis of conscience, whether based on religious beliefs or moral convictions, in certain circumstances. If you believe that [Name of entity] has violated any of these provisions, you may file a complaint with the U.S. Department of Health and Human Services, Office for Civil Rights …”

Entities and recipients subject to the 2024 Final Rule should educate personnel by posting this notice on its website, in a prominent and conspicuous physical location, in personnel materials (such as manuals, handbooks, orientation materials and trainings), in employment applications and in postgraduate education materials. Covered entities or recipients should address any complaints or inquires related to the federal healthcare conscience protection statutes and should cooperate fully if OCR initiates an investigation or request for information.

Tamra Harris is an associate in Holland & Knight’s Chattanooga, Tennessee ,office, and Nina Wall is an associate in the firm’s Nashville, Tennessee, office.

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May 21, 2024 at 01:33 pm by kbarrettalley

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