Eric Bodin

Director, VDH Office of Licensure and Certification

 

My name is Shelley Abrams, and I am the Clinic Director at A Capital Women’s Health Clinic, an independent abortion care provider in Virginia.  I am 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 (“the final adopted regulations”) should be repealed, amended, or retained in their current form.  I urge the Board to repeal the final adopted regulations and rewrite them to address the serious concerns outlined below.

 

Public comment is sought on whether the regulation “is necessary for the protection of public health, safety, and welfare.”  As I will explain, 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 abortion care providers are required to comply with some parts of the final adopted regulations, abortion clinics will be forced to close and women’s health will be in grave danger in Virginia.  Forcing my clinic to close our doors, with no medical justification, cuts my community off from quality medical care for no good reason.  And, the regulations were never about women’s health and safety; to the contrary, they were promulgated as part of a deeply flawed, politicized process bent on shutting down abortion providers.  Because of this, the regulations should be repealed and rewritten.

 

I urge you to repeal and rewrite the regulations for two primary reasons, as set forth below: (1) the regulations are medically inappropriate to first-trimester abortion care providers; and (2) the regulatory process was riddled with political interference from then-Attorney General Ken Cuccinelli, resulting in regulations that will close women’s health centers across the state and do nothing to actually promote patient health or safety. 

 

The final adopted regulations are medically inappropriate for first-trimester abortion care providers.

 

The final adopted regulations do not reflect the safety record of abortion care and the medical requirements of first-trimester abortion providers. Rather, the extensive and burdensome requirements in the regulations impose unnecessary physical plant, 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.  This includes, but is not limited to, application of the Facilities Guidelines Institute’s 2010 Guidelines for the Design and Construction of Health Care Facilities (“the Guidelines”) to first-trimester abortion care providers.

 

First-trimester abortion care is incredibly safe.

 

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 before 13 weeks 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 medical office or abortion facility; 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]

 

Given this safety record, the final adopted regulations contain a variety of requirements that are medically inappropriate to first-trimester abortion care providers and do nothing to promote patient safety. 

 

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] The final adopted regulations also contain myriad administrative, recordkeeping and record storage, and management requirements that are completely unrelated to patient health.  These requirements are medically unnecessary and inappropriate for first-trimester abortion care providers.

 

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.

 

In addition, the final adopted regulations require first-trimester abortion facilities to comply with a number of administrative, recordkeeping and reporting requirements not related to patient health or safety, and not imposed on other health care providers in the state.  We are required, for instance, to promptly report to the Virginia Office of Licensure and Certification (“OLC”) a number of “events,” and we must provide OLC with sensitive information in these reports.[4] This type of reporting is not even required of inpatient hospitals, outpatient surgical hospitals, hospices, or nursing homes in the state of Virginia, and is particularly invasive for abortion care providers.  If reporting these types of events is necessary to protect patient health, then it should be required of all licensed health care facilities, not just to abortion providers.  Singling out abortion care providers in this manner is a blatant attempt to regulate us out of existence.

 

I am not opposed to regulations—I support reasonable regulations grounded in medical need and related to patient health.  But the building, administrative, reporting, record storage, and various other burdensome requirements in the final adopted regulations have nothing to do with patient health.  I urge the Board to repeal and rewrite them to reflect the safety of abortion care, and take abortion care providers’ expertise into account when doing so.

 

The entire regulatory process was a politically motivated attempt to shutter first-trimester abortion providers in the Commonwealth.

 

The State Board of Health has both the authority and the obligation to enact regulations that promote the public health and are consistent with medical evidence.[5] Instead, throughout the course of the regulatory process, the Board was bullied by then-Attorney General Ken Cuccinelli’s office into ignoring medical expertise again and again and ultimately pressured to promulgate 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 political forces so opposed to abortion they will take extreme measures to end access to it. In short, as explained below, the process leading up to the adoption of the final regulations was flagrantly political—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.

 

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, in reviewing an initial draft of the regulations that incorporated the panel’s recommendations, rejected the advice: 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.[6]  The changes made by the Attorney General’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.[7]  

 

The Attorney General’s office used scare tactics to pressure the Board to rescind a revised version of the regulations that was medically appropriate.

 

At the Board’s June 15, 2012 meeting, the Board adopted, consistent 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.[8] 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. 

 

The Board was then subjected to intense, legally flawed pressure from the Attorney General’s office to rescind the grandfather clause.  Subsequent to the June 15 vote, the Attorney General’s office, as promised, refused to “certify” the regulations, claiming the Board lacked the statutory authority to amend the regulations as it had.[9]  Before the Board met again on September 14, 2012, the Board was urged by the Attorney General’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.[10] 

 

The pressure from the Attorney General’s office was not only inappropriate as matter of good governance, the arguments that office made in support of pressuring the Board to rescind the grandfather clause were legally unsound.[11]

 

These scare tactics worked.  The Board, under immense pressure to follow the Attorney General’s advice under threat of bearing “the responsibility of [an individual Board member] to obtain and pay for his or her own legal representation,”[12] removed the grandfather clause at the September 14th meeting, thereby requiring all abortion facilities to meet the Guidelines.  The clear result of Ken Cuccinelli’s bullying is final adopted regulations whose sole goal, by disallowing a grandfather clause or any permanent variance or waiver arrangement, was clearly to shut down safe, legal abortion care providers in Virginia.

 

For the foregoing reasons, I ask that the Board repeal the final adopted regulations or amend them to address these concerns.  The regulations are simply medically inappropriate to first-trimester abortion care providers.  Moreover, the regulations were the result of a deeply flawed, improperly politicized regulatory process.  Thank you for your consideration.

 

Sincerely,

 

Shelley Abrams

Clinic Director

A Capital Women’s Health Clinic

1511 Starling Drive

Richmond, VA 23229

 [1] National Abortion Federation, Safety of Abortion, available at https://www.prochoice.org/about_abortion/facts/safety_of_abortion.html.

 

[2]Guttmacher Institute, Facts on Induced Abortion in the United States, July 2014, available at http://www.guttmacher.org/pubs/fb_induced_abortion.html#10.

[3] See 12 Va. Admin. Code §§ 5-412-370. 

[4] 12 Va. Admin. Code 5-412-320(B).  For instance, we are required to report to OLC if a “significant injury of a patient or staff member resulting from a physical assault that occurs within or on the abortion facility grounds.”  Id.  We are further required to provide the report within 24 hours of its occurrence and provide information about the “actions taken by the abortion facility to protect patient and staff safety and to prevent recurrence.” Id. § (C).

[5] See Va. Code Ann. 32.1-1 (establishing the Board because “the protection, improvement and preservation of the public health and of the environment are essential to the general welfare of the citizens of the Commonwealth.”).

[6] See Comment of James E. Ferguson II, M.D., to the Virginia Board of Health (March 29, 2013).  According to Dr. Ferguson, “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. . . . As rewritten, the Draft Permanent Regulations went well beyond what the advisory panel recommended.”  Comment of James E. Ferguson II, M.D., to the Virginia Board of Health ¶¶ 9, 14 (March 29, 2013).

[7] Id.

[8] See Virginia Regulatory Town Hall, Proposed Regulation Agency Background Document 8 (Jan.8, 2013) (discussing proposed amendment to 12Va. Admin. Code § 5-412-370). 

[9] See Memorandum from Allyson K. Tysinger, Senior Assistant Attorney General, to Dr. Karen Remley, Commissioner, Virginia Department of Health (July 16, 2012). 

[10] Memorandum from Allyson K. Tysinger, Senior Assistant Attorney General, to Members of the Virginia Board of Health (Sept. 12, 2012).

[11] 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.  See Va. Code Ann. § 2.2-4013(A).  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.

[12] Memorandum from Allyson K. Tysinger, Senior Assistant Attorney General, to Members of the Virginia Board of Health (Sept. 12, 2012).