INTRODUCTION

We are a group of independent women’s health centers (“the Centers”) in Virginia.  We are writing in response to the State Board of Health’s (“the Board”) request for public comment regarding whether 12 Va. Admin. Code §§ 5-412 et seq. (“the final adopted regulations”) should be repealed, amended, or retained in their current form.  For reasons explained more fully below, we urge the Board to repeal the final adopted regulations.  In the alternative, we urge the Board to amend the regulations substantially to address the serious concerns outlined below.

These comments are focused primarily on the application of certain chapters of the Facilities Guidelines Institute’s 2010 Guidelines for the Design and Construction of Health Care Facilities (“the Guidelines”) to women’s health centers that provide first-trimester abortion care.

Specifically, the Board sought public comment on whether the regulation “is necessary for the protection of public health, safety, and welfare.”  As we will describe, the final proposed regulations plainly do just the opposite: they threaten the health and safety of women in Virginia seeking safe, legal abortion care.

If women’s health centers that provide first-trimester abortion care are required to comply with the Guidelines, women’s health centers will be forced to close and women’s health will be in grave danger in Virginia. The Centers provide safe, high quality reproductive health care to women, including abortion care, well-woman exams, contraceptives, and options counseling and referrals.  Many have been doing so for over 40 years.  Accordingly, many of the Centers serve as a critical access point to a broad spectrum of comprehensive reproductive health care for women in Virginia.  Forcing the Centers to close our doors, with no medical justification, cuts our communities off from quality medical care for no good reason. The diminishment of access to abortion care will disproportionately harm women in groups that already face significant barriers in accessing health care, such as women of color, young women, rural women, and women without health insurance—for no legitimate reason.

We urge you to repeal the regulations or amend them to remedy these concerns for three primary reasons, as set forth below: (1) application of the Guidelines is medically inappropriate to women’s health centers that provide first-trimester abortion care; (2) the Board lacked statutory authority for applying the Guidelines in the manner it applied them; and (3) the regulatory process was riddled with ideological and political interference from then-Attorney General Ken Cuccinelli, resulting in regulations that will lead to the apparently desired closing of women’s health centers across the state.  In bending to such interference, the Board is jeopardizing the health of Virginia women.

1.      Application of the Guidelines to women’s health centers that perform first-trimester abortions is medically inappropriate and unnecessary.

The final adopted regulations do not reflect the safety record of abortion care and the appropriate level of regulation for women’s health centers that provide first-trimester abortion care. Rather, the extensive requirements under the Guidelines impose unnecessary clinical, financial, and administrative burdens on providers of first-trimester abortion care that are not medically necessary and do not promote or protect patient health and safety.

a.       The application of the Guidelines is medically inappropriate given the safety of first-trimester abortion care.

There are two common types of first-trimester abortion procedures: medical abortion and surgical abortion. Both have excellent safety records.

A medical abortion is one that is brought about by taking medications that will end a pregnancy. Mifepristone can be used for medical abortion, and is taken together with another medication, misoprostol, to induce an abortion. Medical abortion is effective generally up to ten weeks gestation and allows a woman to have a safe, effective abortion without a surgical procedure.

Surgical abortion ends a pregnancy by emptying the uterus with special instruments. Virtually all first-trimester surgical abortions are accomplished by vacuum aspiration, which involves very light suction applied to the contents of the uterus. A routine first-trimester surgical abortion takes approximately 5-15 minutes to complete and is one of the safest types of medical procedures.

Complications from having a first-trimester abortion are considerably less frequent and less serious than those associated with giving birth. Medical abortions have an excellent safety record, with serious complications occurring in less than 0.5% of cases.

Serious complications arising from surgical abortions provided in the first-trimester are also quite unusual.  About 88% of the women who obtain abortion care are less than 13 weeks pregnant.  Of these women, 97% report no complications; 2.5% have minor complications that can be handled at the physician’s office; and less than 0.5% have more serious complications that require some additional surgical procedure and/or hospitalization.[1]

In addition, first-trimester abortions pose virtually no long-term risk of such problems as infertility, ectopic pregnancy, spontaneous abortion (miscarriage) or birth defect, and little or no risk of preterm or low-birth-weight deliveries.[2]

b.      Application of the physical plant requirements in the Guidelines is medically inappropriate to women’s health centers that provide first-trimester abortion care. 

Any physical plant requirements for health care facilities that provide first-trimester abortion care should reflect the medical reality regarding the safety of first-trimester abortion services. In stark contrast, the final adopted regulations incorporate extensive, burdensome physical plant requirements from the Guidelines.[3] These requirements are medically unnecessary and inappropriate for first-trimester abortion care, and imposing them on existing facilities will reduce or eliminate access to care for Virginia women.

Health care facilities are generally regulated based on the nature of the procedures provided at that type of facility. Thus, inpatient hospitals, which are the appropriate medical setting for highly complex and invasive surgeries necessitating an overnight stay, are required to have the most sophisticated facilities. Outpatient surgical hospitals, which are the appropriate setting for a variety of complicated and invasive surgical procedures, are required to have more sophisticated facilities than medical offices, but less sophisticated than inpatient hospitals.

First-trimester abortion, in contrast, is a simple surgical or medical procedure that is typically provided in office-based outpatient settings. As discussed in the preceding section, outpatient abortions performed in the office or clinic setting have an excellent safety record in this country. As a result, the applicable standards of care in the field do not require an outpatient surgical hospital or inpatient hospital setting for the performance of an uncomplicated abortion.

The final adopted regulations require women’s health centers that provide first-trimester abortion care to maintain physical plants that satisfy building requirements for new hospitals. Many provisions in the Guidelines on their face have no relationship to protecting the health of women accessing first-trimester abortion care. Examples of medically unnecessary requirements include: five-foot wide hallways; covered entrances; public telephones, public bathrooms and drinking fountains in waiting rooms; complex ventilation systems; needlessly large janitorial closets; and requiring a minimum number of parking spaces.

We do not oppose reasonable regulations grounded in medical and scientific reality, but imposing the Guidelines on women’s health centers that provide first-trimester abortion care is not necessary for patient safety. In fact, these restrictions endanger women’s health by imposing medically inappropriate requirements on women’s health centers, potentially forcing them to close. The regulations should be repealed and rewritten or amended to reflect the safety and medical reality of first-trimester abortion care.

2.      There was no statutory authority to apply the Guidelines to facilities that provide first-trimester abortion care and the application is inconsistent with the Guidelines themselves.

Importantly, for at least two reasons there was no statutory authority for imposing the chapters of the Guidelines that the Board applied to abortion care providers. 

First, the legislation that directed the Board to regulate first-trimester abortion care providers, Senate Bill 924, amended only one subsection within the Virginia Code, section 32.1-127(B)(1), and in so doing, classified abortion facilities as a category of hospital only “for purposes of this paragraph.”[4] Accordingly, while a different provision of state law mandates that the Board promulgate regulations for “hospitals” that include design and construction standards “consistent with the current edition of the [Guidelines],”[5] that provision of law was not modified in any way by Senate Bill 924—the bill’s reach is on its face confined to § 32.1-127(B)(1) alone.

Second, the legislation requiring the Board to promulgate regulations does not require the Board to use any specific documents or standards.[6] Therefore, neither Senate Bill 924 nor any provision of existing state law requires the Board to incorporate the current version of the Guidelines and the suggestions by and to the Board that it was so required were plainly in error.

Moreover, even if state law mandated that the Board promulgate regulations that include design and construction standards consistent with the current editions of the Guidelines, the Guidelines on their face apply only to new construction and significant renovations or additions.  Specifically, the Guidelines state that they are “intended as minimum standards for designing and constructing new health care facility projects.”[7]  Thus, to be “consistent” with the Guidelines, the regulations would have to apply only to new construction and significant renovations or additions—not to existing facilities that are not undergoing renovations or additions, and are providing the same services they have safely provided for years.  It simply makes no sense to require existing health care facilities to comply with standards that were never intended to apply to them, and there is no medical reason for imposing these burdens on health care facilities.

Even if the enabling legislation were deemed to have required the Board to apply the Guidelines to first-trimester abortion facilities, the Board’s inclusion of existing facilities in the regulations means that the Board did not act in a manner “consistent” with the Guidelines, which apply only to new construction.  As a result, the regulations unjustifiably create the risk that existing health care facilities will be forced to undertake extremely expensive renovations, move, or shut down—all with no attendant benefit to women’s health.  The necessary conclusion is that the Board should repeal the final adopted regulations and, if needed, start the process anew.

3.      Application of the Guidelines to women’s health centers that provide first-trimester abortion care was a politically motivated attempt to shutter abortion providers in the Commonwealth.

The Board has both the authority and the obligation to enact regulations that promote the public health and are consistent with medical evidence.[8] Instead of following that regulatory charge, however, the Board allowed itself throughout the course of the regulatory process to be bullied by then-Attorney General Ken Cuccinelli’s office into ignoring medical expertise, and promulgating unreasonable and medically unsound regulations.

With respect to application of the Guidelines, in two specific instances it was clear that the Board’s mandate was being coopted by ideological and political forces so opposed to abortion they will take extreme measures to end access to it. As explained below, the process leading up to the adoption of the final regulations was precisely the opposite of the proper and statutorily-mandated role of the Board to craft objective, medically sound regulations designed to protect the public health and safety.

a.       Ken Cuccinelli insisted on ignoring medical expert advice during the drafting phase.

After passage of Senate Bill 924, a medical advisory panel comprised of women’s health care experts was appointed to provide guidance in ensuring the regulations were consistent with current medical and scientific standards.  Ken Cuccinelli’s office, in reviewing an initial draft of the regulations that incorporated the panel’s recommendations, rejected the advice.

As a result, several of the advisory committee’s recommendations, including grandfathering in existing clinics with respect to application of the Guidelines, were ignored when the regulations were eventually promulgated.[9]  The changes made by Ken Cuccinelli’s office were so out of line with what the panel had recommended that at least one of its members requested that his name no longer be associated with the regulations as revised.[10]

b.      Ken Cuccinelli used scare tactics to pressure the Board to rescind a revised version of the regulations that was medically appropriate.

Having rejected the advice of medical experts, Ken Cuccinelli’s office then doubled down on its efforts to impose medically unnecessary regulations that were not grounded in science.

At the Board’s June 15, 2012 meeting, the Board adopted, consistent with the medical advice of the safety of first-trimester abortion care and with the advice of the advisory panel, a grandfather clause amendment which would have allowed existing first-trimester abortion care clinics to continue operating in their current buildings.[11]  At that meeting, the Attorney General’s office told the Board that it could not legally adopt the amendment and that the office would refuse to “certify” the regulations if the grandfather clause was adopted. 

Following the meeting, the Board was subjected to intense, legally flawed pressure from Ken Cuccinelli to rescind the grandfather clause.  Subsequent to the June 15 vote, his office, as promised, refused to “certify” the regulations, claiming the Board lacked the statutory authority to amend the regulations as it had.[12] Before the Board met again on September 14, 2012, the Board was urged by Ken Cuccinelli’s office to promulgate a new version of the regulations that did not contain the grandfather clause.  In a memo from that office, the Attorney General did not mince words about the consequences of refusing to do so:

Should a Board member choose to disregard the Attorney General’s advice and subsequently be named in a lawsuit related to the particular Board action taken, such as the recent litigation challenging the certificate of public need program which named every Board member as an individual defendant, the Attorney General is not obligated to provide representation and it is within the discretion of the Attorney General to decline both representation of the Board member and the appointment of special counsel.[13]

The pressure from Ken Cuccinelli was not only inappropriate as matter of good governance, the arguments that the office made in support of pressuring the Board to rescind the grandfather clause were legally unsound.  Under Virginia law, the Attorney General has no authority to approve or “veto” regulations.  The Attorney General is authorized only to review regulations to ensure statutory authority for them.[14]  Indeed, nothing in Virginia law gives the Attorney General’s office “veto power” over the Board’s policy decisions about what to include in public health regulations

However, these scare tactics worked as intended.  The Board, under immense pressure to follow Ken Cuccinelli’s advice under threat of bearing “the responsibility of [an individual Board member] to obtain and pay for his or her own legal representation,”[15] removed the grandfather clause at the September 14, 2012 meeting, thereby requiring all abortion facilities to meet the Guidelines.  The result of Ken Cuccinelli’s impermissible pressure was the Board’s promulgation of final regulations that advanced an ideological agenda, not regulations promulgated to promote patient health and safety. 

CONCLUSION

For the foregoing reasons, we ask that the Board repeal the final adopted regulations or, in the alternative, amend them substantially to address these concerns.  Application of the Guidelines is simply medically inappropriate to women’s health centers that provide first-trimester abortion care.  Moreover, the Board lacked the statutory authority to apply the Guidelines to the Centers.  Finally, the regulations were the result of a deeply flawed, improperly politicized regulatory process. 

Thank you for your consideration.

Sincerely,

Jill Abbey

Richmond Medical Center for Women

118 North Boulevard

Richmond, VA 23220

Rosemary Codding

Falls Church Healthcare Center

900 S. Washington St.

Falls Church, VA 22046

Dr. David Peters

A Tidewater Women’s Health Clinic

891 Norfolk Square

Norfolk, VA 23502  

Elisabeth Van Der Woude

Amethyst Health Center for Women, Inc.

9380-B Forestwood Lane

Forestwood Professional Villege

Manassas, VA 22110