Virginia Regulatory Town Hall
Agency
Virginia Department of Health
 
Board
State Board of Health
 
chapter
Regulations for Licensure of Abortion Facilities [12 VAC 5 ‑ 412]
Action Amend Regulations Following Periodic Review
Stage Final
Comment Period Ended on 3/22/2017
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3/22/17  4:31 pm
Commenter: Medical Professionals

Promptly Adopt the Final Amendments and Return to Evidence-Based Rulemaking
 

Dear Dr. Levine and Board of Health members:

We are a group of medical providers, including physicians, physician’s assistants, nurse practitioners, registered nurses, and administrators. While there is no legitimate medical reason to regulate medication or surgical abortion differently than the provision of any other medication or similar office-based procedure, given the current statutory framework we support the amendments to the Regulations for Licensed Abortion Facilities, as passed by the Board of Health in October 2016, certified by the Attorney General in November 2016, and approved by Governor Terence McAuliffe in January 2017 (the “Approved Amendments”), as an important first step to bringing Virginia law into compliance with governing medical standards and federal law.

We also commend Governor McAuliffe and the Board of Health for their commitment to protecting access to comprehensive reproductive healthcare in Virginia, and returning to science-based rulemaking to ensure that medical care stays between patients and their medical providers.

As medical professionals, patient safety is of paramount importance to us. We support laws that are necessary to protect patient health and safety. Reproductive healthcare is essential to overall health, and access to abortion is an important component of gynecology. Laws that regulate any type of health care, including abortion, should be evidence-based and designed to improve patient health, not forward a political agenda.

As dozens of doctors and medical professionals have testified before the Board over the past five years, the current regulations target medical professionals who provide first-trimester abortions for unequal treatment without valid justification.

In Virginia, the only health professionals who can lawfully provide abortions are state-licensed physicians—i.e., individuals whom the State has deemed qualified to practice. See Va. Code § 18.2-72; §§ 54.1-2929, 2930; see also 18 VAC 85-20 (detailing qualifications, professional standards, and disciplinary procedures for physicians). Abortion providers in Virginia are highly qualified to provide quality abortion care. Like other medical specialties, they have received medical education and passed formal licensing exams. Practitioners providing abortion have received training to competency in abortion care, including the prevention, recognition, and management of complications. And while Virginia providers must be licensed physicians, we know licensed practitioners – including nurse practitioners, physician assistants, registered nurses, and other health professionals – trained in abortion care safely provide abortion care in other states. See Weitz et al., Safety of Aspiration Abortion Performed by Nurse Practitioners, Certified Nurse Midwives, and Physician Assistants Under a California Legal Waiver, 102 Am. J. Pub. Health 454 (2013). Any suggestion that abortion providers are somehow less qualified or capable than other medical professionals is simply wrong.

As medical evidence shows, first-trimester abortion is an extremely safe in-office medical procedure. The professionalism of abortion providers is one reason why first-trimester abortion today is exceptionally safe. An analysis of major studies found the risk of major complications requiring hospitalization after a first-trimester abortion is 0.5%. White et al., Complications from First-Trimester Aspiration Abortion: A Systematic Review of the Literature, 92 Contraception 422, 434, 435 tbl. 7 (2015; see also Weitz et al., Safety of Aspiration Abortion Performed by Nurse Practitioners, Certified Nurse Midwives, and Physician Assistants Under a California Legal Waiver, 103 Am. J. Pub. Health 454, 458 & tbl. 2 (2013) (finding a less than 0.23% risk of major complications following an abortion performed by non-physician clinicians—who are unnecessarily excluded from providing abortion care in Virginia). The mortality rate from abortion-related complications is just 0.05%. Ushma D. Upadhyay et al., Incidence of Emergency Department Visits and Complications After Abortion, 70 Obstetrics & Gynecology 175, 179 (2015). As physicians, medical professionals, and leading medical and public health organizations have repeatedly informed the Board, there is no medically sound reason to assume abortions performed in a hospital or outpatient surgical center are safer than those performed in a women’s health clinic or medical office setting.

In fact, when striking down abortion regulations in Texas that were nearly identical to the standards imposed by 12 VAC 5-412-370, the Supreme Court of the United States found that such standards have “no benefit when complications arise in the context of an abortion produced through medication,” and, even in the context of surgical abortions, “‘have such a tangential relationship to patient safety . . . as to be nearly arbitrary.’” Whole Woman's Health v. Hellerstedt, 136 S. Ct. 2292, 2315-16 (2016). The Court also clarified that to be constitutional, an abortion restriction must have an evidence-based medical benefit that outweighs the burdens it imposes on abortion access. Id. at 2309-10.

As abortion is a simple and common medical procedure, and given abortion providers’ excellent safety record, there is no medical reason to single them out for disfavored regulatory treatment. Highlighting this discrepancy, under Virginia law, procedures such as colonoscopy or cosmetic surgery that require general anesthesia and/or have complication and mortality rates similar to or higher than those associated with abortion may be performed in a medical office setting. 18 VAC 85-20-320. Providing first-trimester abortion in a medical office setting has long been consistent with the best practice standard of care, and prior to 2012, abortion providers were governed by the same regulations as other physicians performing office-based outpatient procedures. More stringent regulations were not necessary in 2012, nor are they necessary now, to improve the safety of first-trimester abortion care in Virginia. The Approved Amendments to 12 VAC 5-412-80 will ensure abortion facilities may obtain variances from impractical regulations that do not affect patient health and safety, and that are not imposed on similarly situated physicians.

Additionally, the Approved Amendments will revoke existing regulations intended to aid in the harassment of, or violence against, abortion providers and their staff. For example, 12 VAC 5-412-320 currently requires abortion providers to disclose to the Department of Health every incident reported to a malpractice insurer. Such regulations have been used to harass abortion providers and interfere with patient care. Additionally, 12 VAC 5-412-330 and -360 currently subject abortion facilities’ safety rules—including their emergency response plans and internal layout—to Freedom of Information Act requests. These provisions lack any medical benefit, and instead put abortion providers, their staff, their patients at risk.

The Approved Amendments also correct regulations that are inappropriate as applied to facilities in which first-trimester abortions are provided. For example, provisions in 12 VAC 5-412-370 designed to safeguard heavily sedated patients (who are unable to help themselves) do not help abortion patients, as first-trimester abortion facilities do not use general anesthesia or deep sedation. Additionally, under the Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd (“EMTALA”), emergency rooms are required to accept patients regardless of whether a transfer agreement exists between that hospital and an abortion provider. The transfer agreements required by 12 VAC 5-412-290 accordingly do not improve patient health and safety.

Regulating facilities that provide first-trimester abortion care more stringently than those that perform higher-risk procedures does not improve patient health. The current regulations are not grounded in evidence-based medicine, and their onerous burdens are wholly disproportionate to the very low risk involved in abortion care. The current regulatory scheme does nothing more than attempt to price abortion facilities out of existence and delay and deny patients’ access to quality abortion care, frustrating their ability to exercise their right to control their bodily autonomy guaranteed by the constitution. It also creates significant obstacles for appropriately trained physicians wishing to incorporate abortion care into their existing primary care or OB/GYN practices. The overall effect of the current regulatory scheme is to punish and stigmatize physicians who provide critical abortion care to their patients, and to reduce access to quality abortion care in Virginia.

We support the Approved Amendments because they are necessary to improve reproductive health care in Virginia, bring the most onerous of Virginia’s Regulations of Licensed Abortion Facilities in line with federal law, and return to the Board of Health’s long-held practice of evidence-based rulemaking. More broadly, we urge the Commonwealth to engage in a constitutional review of its entire scheme of abortion restrictions, including provisions of 12 VAC 5-412 not affected by the current amendments and other statutes designed to place an “undue burden” on reproductive healthcare patients, to eliminate provisions inconsistent with Whole Woman’s Health v. Hellerstedt.

Jill C. Abbey, Richmond Medical Center for Women

Jane Allen, MD

Angela Bess, MD

Anne Brown, MD

Rose Codding, Policy Director, Falls Church Healthcare Center

Janet Dix, PA (retired)

Allison Durica, MD

James E. Ferguson, II, MD/MBA

Gail Frances, NP, Annandale Women and Family Center

Aaron Goldberg, MD

Melissa Grant, Vice President, Carafem

Virginia Hackenberg, MD

Sarah Imershein, MD

Gillian Jacob, MD

Michelle Justice, MD

Kris Kennedy, MD FACOG

Alfred Khoury, MD

Amy Hagstrom Miller, Founder, President and CEO, Whole Woman’s Health

Kenneth Olshansky, MD

Michelle Roberts-Borden, MD

Preetika Sidhu, MD

Lisa Spiller-Davis

Sharon Williams Utz, PhD, RN, Associate Professor Emerita, University of Virginia, Virginia Registered Nurse License #0001110195

CommentID: 58227