On December 19, 2008, the U.S. Department of Health and Human Services (HHS) published a final rule entitled "Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law." The final rule specifically prohibits any entity or individual, including but not limited to healthcare professionals, hospitals, healthcare training programs, HMOs, health insurance plans, accrediting bodies and certain components of state and local governments, that receive many types of federal HHS financial assistance, funds, services or benefits, including Medicare and Medicaid funds, from discriminating against other individuals or entities for refusing to engage in certain activities due to religious or moral beliefs. While the final rule proscribes different actions for different types of entities and individuals, it is generally targeted at prohibiting discrimination against entities and individuals who refuse to provide or be trained to provide, engage in, pay for, provide coverage for or refer for abortions, sterilization procedures or certain types of research activities. While directed primarily at abortion or sterilization, the regulation may have a much wider scope and cover those opposed to many other aspects of healthcare such as assisted suicide, sex change operations, vaccinations and family planning.

The final rule also protects individuals who refuse to "assist in the performance" of such procedures or research for personal, moral or religious reasons. In the commentary to the final rule, HHS attempts to clarify the phrase "assist in the performance" by defining it as "any activity with a reasonable connection to a procedure, health service or health service program, or research activity." This is a fairly broad definition and, while HHS has provided little guidance as to its limits, was expressly crafted to reach beyond "direct involvement with a procedure, health service, or research activity."

Forms of discrimination proscribed by the final rule include refusing to employ or promote, terminating, or limiting or denying staff privileges, denying an individual admission to a training program, denying an entity accreditation or license, refusing to provide financial assistance, services or benefits, or requiring an individual to perform or assist in performing any health service program or research activity that would be contrary to the individual's religious beliefs or moral convictions. Complaints regarding alleged discrimination will be accepted and processed by the HHS Office for Civil Rights.

In addition to prohibiting these discriminatory acts, the final rule requires recipients of federal financial assistance, services and benefits to certify their compliance. However, some practitioners and providers are exempted from the certification requirement, including (1) physicians, physician offices, other healthcare practitioners participating in Medicare Part B and/or Part C, when such individuals or organizations are subrecipients of funds through a Medicare Advantage plan; and (2) entities being paid for services by state Medicaid programs. However, if an exempt person or organization is a recipient or sub-recipient of HHS funds through another program, or mechanism, they may be required to provide a certification. The form of certification is set forth in the rule itself and must be executed and submitted upon initial application for a grant or contract subject to the rule, as well as upon any subsequent renewal or extension that extends the term of or amount paid under the grant or contract. It is also important to note that each direct recipient is required to obtain and maintain certifications from any and all "sub-recipients." "Sub-recipient" is broadly defined as an organization or individual who indirectly receives funds from HHS or a component of HHS through a recipient or another sub-recipient to carry out a project or program. Thus, most recipients of federal HHS funds should include the required certifications in their agreements with contractors and subcontractors, much like the Business Associate Agreement requirements of HIPAA.

This regulation will also significantly increase the burden of providers to assure compliance with state laws requiring disclosure of certain rights to patients regarding procedures, such as those requiring hospitals to offer emergency contraception to rape victims or requiring pharmacies to offer Plan B pills to women.