I have reviewed the Virginia Regulations for Licensure of Abortion Facilities (the “Draft Permanent Regulations” or “Regulations”). For the reasons set forth below, I do not believe that the Draft Permanent Regulations should be adopted in their current form. They will impose unnecessary and unreasonable financial and compliance burdens on providers of first trimester abortion services that are neither necessary nor reasonably calculated to promote patient health and safety.
I am a board-certified obstetrician and gynecologist with a subspecialty in Maternal Fetal Medicine. I currently serve as The W. Norman Thornton, Jr. Professor and Chair of the Department of Obstetrics and Gynecology at the University of Virginia in Charlottesville, Virginia.
I received my medical degree in 1977 from the Bowman Gray School of Medicine at Wake Forest University in Winston-Salem, North Carolina. I then completed a flexible internship at the U.S. Public Health Service Hospital in San Francisco, California. Next, I served as a resident at Stanford University School of Medicine from 1978-1980 before becoming a chief resident from 1980-1981 at North Carolina Baptist Hospital/Bowman Gray School of Medicine in Winston-Salem, North Carolina. Following one year in private practice, I completed a fellowship in Maternal-Fetal Medicine at Stanford University School of Medicine from 1982-1984. Upon completion of the fellowship, I became an Assistant Professor in the Department of Obstetrics and Gynecology at Stanford University School of Medicine, where I served until 1987. From 1987-2002, I served as an Assistant Professor, Associate Professor, and Professor in the departments of Obstetrics and Gynecology and Radiology at the University of Virginia School of Medicine. In 2002, I became The John W. Greene, Jr. Professor and Chair in the Department of Obstetrics and Gynecology at the University of Kentucky. After pursuing my MBA from George Washington University from 2006-2008, I returned to the University of Virginia in 2009 and served as The John M. Nokes Professor and Chair of the Department of Obstetrics and Gynecology until 2011, when I assumed my current position as The W. Norman Thornton, Jr. Professor and Chair.
Former Virginia Commissioner of the Department of Health, Karen Remley, asked me to join the Virginia Department of Health’s Medical Advisory Board for the purpose of providing guidance on draft regulations of women’s health care centers in Virginia. I agreed to provide assistance because I believed that my participation could be beneficial. I was appointed to a panel with five preeminent physicians in Virginia. The panel worked collaboratively to provide medical counsel to the Virginia Department of Health during the draft temporary regulation process.
The original regulations drafted by the panel were developed based on the expert opinions of the panel and after review of other guidelines and regulations of different groups, including the American Congress of Obstetricians and Gynecologists. In drafting the regulations, we relied on information and opinions provided by groups that are knowledgeable of and well-established in this area of care. The stated purpose was to draft regulations that would contribute to having safe, appropriate facilities for patient care.
The original regulations focused on good medicine and medical practices, and addressed issues such as appropriate follow-up monitoring of patients, methods for establishing gestational age, and ensuring appropriate patient care. The panel’s regulations also offered guidelines on patient confidentiality, screening for sexually transmitted diseases if undergoing an abortion, provider credentialing, and appropriate follow-up care.
During this process, we were also asked to review building requirements from South Carolina pertaining to facilities that perform both first- and second-trimester abortions. Second-trimester abortions must be performed in hospitals in Virginia; therefore, the panel concluded that most of South Carolina’s guidelines were unnecessary.
After the panel had concluded drafting its version of the regulations, it submitted its version of the regulations for review.
When the draft permanent regulations were returned from Virginia Attorney General Kenneth Cuccinelli’s office, the regulations were heavily edited and vastly different from those developed by our committee of physicians and submitted for review by officials. I concluded that I could not support the regulations and asked to have my name removed from them.
Many aspects of the Draft Permanent Regulations, which are currently under review for final approval by the Virginia Board of Health, are unnecessary from a medical perspective to protect patient health and safety. In particular, the requirements that clinics that provide first trimester abortions maintain physical plants that satisfy building requirements for new hospitals are not reasonably designed or necessary to promote patient health and safety. These requirements will, instead, impose a significant and unnecessary financial burden on such women’s health clinics.
The clinics subject to the Regulations perform first trimester abortions. The Draft Permanent Regulations, however, require these clinics to meet the facilities requirements applicable to hospitals.
Many provisions in the Draft Permanent Regulations have nothing to do with patient care and safety, do not improve patient outcomes, and do not serve to better and/or protect the health of women undergoing first trimester abortions, which are outpatient procedures. For example, the regulations require clinics to build five-foot wide hallways throughout the women’s health care centers; add new covered entrances, public telephones, and public bathrooms and drinking fountains in waiting rooms; incorporate new ventilation systems; and even regulate the size of janitorial closets. The regulations require these clinics to provide four parking spaces for each room that is routinely used for surgical procedures plus one space for each staff member. Such regulations do not address medical concerns relevant to protecting the health of such patients.
The lack of any reasonable connection between the Draft Permanent Regulations and patient health is further confirmed by the fact that other clinics and ambulatory surgical facilities performing comparable or more medically significant procedures, including dentistry and liposuction, are not regulated to the extent these women’s health clinics will be regulated.
As rewritten, the Draft Permanent Regulations went well beyond what the advisory panel recommend. The revised Regulations from the Attorney General’s office include many provisions taken from regulations adopted by South Carolina, which cover facilities providing first- and second-trimester abortions. However, those regulations are inappropriate for Virginia because Virginia already has rules governing second trimester abortions, which are regulated differently from first trimester abortions. Under existing regulation in Virginia, second-trimester abortions must be performed in hospitals. Accordingly, there is no need for regulations imposing a hospital facility level standard for such abortions. And because first trimester abortions are a significantly different procedure, there is no medical basis for imposing the same requirements on first trimester abortions as second trimester abortions. The Revised Draft Permanent Regulations ignore this difference.
When talking about regulations involving medical care, the focus should be on evidence that they are medically necessary and reasonably calculated to enhance patient health and safety. Here, rather than improving patient health and safety, the Regulations impose requirements on these clinics that are not medically necessary and will adversely affect patients by increasing the cost of services or reducing the availability of services where clinics and/or their patients cannot absorb the substantial additional costs that must be incurred to meet hospital facility standards. Thus, in my judgment, the net result of the Regulations will be counterproductive to patient health and safety.
In sum, the Regulations currently under review do not represent the opinions of the medical community or reflect sound medical practice. To the contrary, they are medically unnecessary and will, if anything, adversely affect women’s health care in the Commonwealth. It is regrettable that an important issue of public health is not being addressed on the merits, but instead based on political considerations.
