HHS New Provider Conscience Regulations
By Kim Worobec, Esq. and Jennifer Gray Esq., Hooper Lundy Bookman in Los Angeles CA

Summary by Seraka Davis, North Carolina Central University School of Law, Class of 2009

Expanding on standards that have been in existence for several decades, on December 19, 2008, the Department of Health and Human Services issued final regulations that interpret and enforce the federal “Provider Conscience” laws. The “Provider Conscience” laws are a combination of language contained in the Church Amendments, Public Health Services Act (“PHSA”) Section 245 and the Weldon Amendment. The regulations in place prior to December 2008 prohibited the government and recipients of HHS funding from discriminating against healthcare providers and other individuals who refused to perform or participate in lawful health service and research activities on the basis of religious or moral convictions. The regulations also sought to prohibit the government and recipients of HHS funding from discriminating against healthcare providers who perform healthcare activities such as abortions and sterilizations, but they lacked the enforcement ability. The Provider Conscience Regulations were introduced to protect physicians and other medical professionals from penalization and disciplinary action as a result of their decision not to participate in controversial medical procedures.

The new “Provider Conscience” regulations may be found at 45 C.F.R. Part 88. They greatly expand the scope of the previous regulations by broadly defining relevant terminology and expanding the groups of persons and healthcare activities covered under the regulations. For example, the regulations define the term “assist in the performance” very broadly and provide protection from scrutiny for anyone with a reasonable connection to a medical procedure, health service, health service program, or research activity. The new regulations also define the term “workforce” as used in the definition of “assist in the performance” not only to include employees (ranging from physicians to janitors), and contractors, but also volunteers, trainees and individuals with privileges to a healthcare facility or organization.

As these regulations only became effective on January 20, 2009, it remains to be seen what their overall impact will be. One issue of potential concern raised by HHS grantees is handling a scenario where an entire staff objects to a medical procedure on behalf of a patient. HHS has stated that despite the protection granted to employees under the “Provider Conscience” regulations and the fact that individual healthcare workers may object to providing certain procedures, healthcare entities will still be expected to meet their legal requirements to provide proper healthcare services. At issue by the Obama Administration is whether or not these regulations should be amended or repealed. Whatever the outcome, the current discussion of these issues and their possible enforcement are vital to the medical community.

Certifications of compliance are set to be phased in this fall. Thus, almost all grantees and many sub-grantees of HHS funding will be required to adhere to these new standards or face dire consequences. It is evident from HHS’ response to commentators’ requests and suggestions that the new regulations will be strictly enforced. HHS will work with grantees in violation of the regulations to assist them in becoming compliant, but continued violation of the regulations after HHS has provided assistance may result in serious consequences. Failure to adhere to the Provider Conscience regulations may result not only in termination of a recipients’ future HHS funding, but possibly being forced to return funding received in the past.

As the Provider Conscience Statues and the new regulations are now effective and possibly enforceable, impacted healthcare entities should review their existing compliance programs and work to develop necessary procedures to come into compliance with these regulations.

For more information on HHS’ new Provider Conscience regulations, see Volume 21, Number 4, April 2009 of The Health Lawyer. [Members Only PDF].

Seraka Davis is a 3L at North Carolina Central University School of Law in Durham, North Carolina. She is a volunteer with the Elder Law Pro Bono Project at her school. She graduated cum laude from Salisbury University with a degree in Political Science. Seraka is interested in healthcare compliance, elder law and healthcare provider contract negotiation.