|Action||Amend the Regulation after Assessment and Receipt of Public Comment|
|Comment Period||Ends 10/31/2018|
NOIRA TRAP Comment
The memorandum found at https://www.womenshealthcoalitionva.org/wp-content/uploads/2018/10/TRAP-Public-Comment-VA-Coalition-to-Protect-Womens-Health-FINAL-10.31.2018.3.pdf and submitted by the Virginia Coalition to Protect Women’s Health (“the Coalition”) as public comment on the Virginia Board of Health’s (the Board) rulemaking process to amend the regulations for the licensure of abortion facilities, 12 VAC 5-412. The Board of Health issued this NOIRA to gather comments suggesting regulatory changes to aid in its review and assessment of all regulatory language in 12 VAC 5-412 and to ensure that it meets the Board’s responsibilities under § 32.1-127. While we maintain that abortion clinics are already subject to the requisite regulatory, professional, and licensing standards as outpatient medical providers, we recommend the following in order to render the regulations more in line with evidence based medical practice. If that is the way the comment ends up being drafted, this framing will need to be weaved throughout the comment.
The members of this Coalition are health care providers and women’s health advocates. In 2011, we came together in response to Senate Bill 924, which classified “facilities in which 5 or more first trimester abortions per month are performed” as a category of hospitals for a limited purpose. The bill became law in March of 2011 and, along with subsequently promulgated regulations, had the effect of limiting women’s access to safe abortion care across the Commonwealth. We support proven and medically sound regulations that genuinely advance the public health.
Abortion providers in Virginia are already subject to a host of regulations and standards, like any other similarly situated medical provider. The Department of Health Professions’ (VDHP) authority, separate from that of the Virginia Department of Health, regulates healthcare providers licensed by the boards within VDHP including the Boards of Medicine, Nursing and Pharmacy. This Department has its own inspection, investigative and enforcement authority and can refer violators to the Office of the Attorney General for criminal prosecution when necessary and impose monetary penalties. Virginia’s Board of Medicine also has enforcement and licensing authority over physicians and clinicians in the Commonwealth.
The associated regulations further outline standards of practice, covering necessary details ranging from informed consent to discharge requirements. A special set of requirements governs the administration of anesthesia in office-based settings.
This regulatory scheme already ensures that reproductive healthcare is safe; there is no need for special targeted abortion facility regulations that are medically unnecessary and extremely burdensome, regulations that have forced some health care facilities to close and that make it difficult to open new facilities.
It is also important to remember that abortions are already an incredibly safe medical procedure. A 2014 ANSIRH issue brief notes that “less than a quarter of one percent of abortions result in a major complication”; “less than one percent of abortions result in a complication that is diagnosed and treated in an emergency room” and “the overall complication rate is lower than those for wisdom tooth removal and tonsillectomy.” Medication abortion is extremely safe, with serious adverse events occurring in less than one-third of one percent of medication abortions. In fact, “[s]erious complications are rare and occur far less frequently than during childbirth. Safety is enhanced when the abortion is performed as early in pregnancy as possible.”
In the memorandum at https://www.womenshealthcoalitionva.org/wp-content/uploads/2018/10/TRAP-Public-Comment-VA-Coalition-to-Protect-Womens-Health-FINAL-10.31.2018.3.pdf, we highlight the most important areas of concern that should be considered as this process begins. While we appreciate the regulatory changes that have already been made in 2016, it is important to note that many of the issues raised in previous rounds of regulatory review persist today. We would like to reiterate that we still stand by all of the changes and amendments suggested in the February 11, 2015 public comment submitted by this Coalition during the last regulatory review, and we would like to see each of the suggested changes that have not been implemented taken up by the Board of Health for consideration this time.
In Virginia, there is not, and never has been, a proven, medically justifiable reason for regulating abortion providers like hospitals. Until 2011, abortion providers and their practices were regulated like other physician groups and their practices. With the passage of TRAP (“targeted regulation of abortion providers”) laws in Virginia in 2011, abortion providers, and only abortion providers, were singled out for targeted, politicized regulations and restrictions by the state. These targeted restrictions had only one aim – to restrict and ultimately eliminate access to abortion in Virginia. These restrictions can do this by shutting down women’s health centers where abortion is performed, preventing physicians from performing abortions in their offices, and preventing new women’s health centers from opening. These restrictions also stigmatize abortion patients and providers, manifesting the State’s disapproval of the fundamental right to abortion at every entry-point in care. Meanwhile, there is no proven reason grounded in patient health and safety that the Virginia Department of Health should license only abortion providers and no other physician group or medical office, as a category of hospital. It is important to note that, while the authorizing statute requires that VDH regulate providers that perform five or more first trimester abortions per month as a category of hospitals, there is no requirement that VDH treat all categories of hospitals in the same way.
We believe the licensing requirement and the TRAP statues are unconstitutional, unduly burdensome and medically unnecessary.
 See VA Code Ann. Sec. 54.1-2400, -2505, -2506 et. seq.
 See VA Code Ann. Sec. 54.1-2400(7), - 2915(A)(6).
 See 18 Va. Admin. Code Sec. 85-20 et seq.
 “The Safety and Quality of Abortion Care in the United States” A Consensus Study Report, National Academies of Sciences, Engineering and Medicine, March 2018, at http://nationalacademies.org/hmd/Reports/2018/the-safety-and-quality-of-abortion-care-in-the-united-states.aspx. At 10.
 Safety of abortion in the United States, Issue Brief #6, December 2014, Advancing New Standards in Reproductive Health. See also “the Safety and Quality of Abortion Care in the United States,” at 53.
 Safety and effectiveness of first-trimester medication abortion in the United States, Issue Brief, August 2018, Advancing New Standards in Reproductive Health.
 “The Safety and Quality of Abortion Care in the United States” A Consensus Study Report, National Academies of Sciences, Engineering and Medicine, March 2018, at http://nationalacademies.org/hmd/Reports/2018/the-safety-and-quality-of-abortion-care-in-the-united-states.aspx. At 11.
 “Most abortions can be provided safely in office-based settings.” “The Safety and Quality of Abortion Care in the United States” A Consensus Study Report, National Academies of Sciences, Engineering and Medicine, March 2018, at http://nationalacademies.org/hmd/Reports/2018/the-safety-and-quality-of-abortion-care-in-the-united-states.aspx. At 10.