HHS’ PROVIDER CONSCIENCE REGULATIONS

In mid-December, the U.S. Department of Health and Human Service (HHS) issued its final regulations attempting to interpret in providing for enforcement of “provider conscience” statutes and regulations.

While these statutes are not new, new regulations expand the scope by broadly defining terms to allow a greater number of organizations, employees and volunteers to refuse, on religious and moral grounds, participation in a wider array of activities, including medical services, research, training and referrals. The new regulations, located at 45 CFR Part 88, are now effective. During 2009, HHS will begin requiring written certifications of compliance with these statutes by almost all HHS funding recipients and even some sub-recipients or sub-grantees.

In summary, the statutes and the regulations prohibit the federal government and recipients of HHS’ funding from discriminating against healthcare providers who refuse to perform or participate in otherwise lawful health service and research activities on the basis of the funding recipients or funding recipients’ employees for religious and moral convictions. These activities include issues as to birth control, artificial insemination, withdraw of life support. They can include any other health service to which an individual states a sincerely held religious or moral objection. Please note that the statute and the regulations also prohibit our government and recipients of HHS funding from discriminating against healthcare providers who do perform certain healthcare activities, such as abortions and sterilizations. In other words, what appears on the surface to be merely allowing conscientious objection to certain procedures may also act as a prohibition against certain organizations from discriminating against those who do the very things against which they object.

The statutes generally prohibit entities from receiving US funding from discrimination against physicians and other healthcare personnel in employment, promotion, termination of employment or the extension of staff or other privileges because the individual either performed or assisted in the performance of a lawful sterilization procedure or abortion or refuse to perform or assist in the performance of such a procedure on morally religious grounds.

Under the new regulations, the term “assist in performance” is defined for the first time and is generally described as participation in any activity with a reasonable connection to a procedure if the individual involved is part of the workforce of a US/HHS funding entity. This may include counseling, referral, training and other arrangements for the procedure, health service or research activity in addition to what would be commonly called “assisting”.

The regulations give examples including the obvious that “an operating nurse would assist in the performance of surgical procedures” but does not limit it to such a direct connection. Further, the definition of workforce in these regulations not only includes employees and contractors, but also volunteers, trainees and individuals with privileges at the funder entity.

Healthcare entities impacted by these statutes and regulations should adopt or review existing anti- discrimination policies and compliance programs. You should also consider how to handle any claims of discrimination with regard to these statutes and regulations and individual healthcare providers should consider how their actions, acceptance of procedures or refusal to complete procedures may interact with these statute and these new regulations.

If you would like to discuss any issue, or to have assistance in reviewing any of your decisions or written policies, please feel free to contact me.

This newsletter is edited by Paul Wallace, a member of the American Bar Association Healthcare Law Section who has been representing physicians and healthcare practices for 30 years. Mr. Wallace assists physicians in health practices in contract items, federal legal compliance, creation of practice entities, estate and wealth planning and similar issues.

Please feel free to call if you have any questions about this newsletter or any other matter.