I ask you to please support amendments to roll back the sham restrictions on Virginia's womens health centers that restrict access to safe and legal medical procedures.  Really quite upset that we STILL have to fight for our legal access to these procedures.

 

 

Thank you so much for the support of the women and men in VA seeking abortion care..  Thanks to the Govenor and the Board for health decisions, not a political agenda, when addressing regulations  for abortion care services.

Your time and attention to this health matter is greatly appreciated.

Penelope Smith

I look forward to an enlightened, revised and amended 5-412 such that science based best practices will be consistent with any and all in-office provision of out-patient care not just abortioncare.

Thank you Board of Health members: when we can correct an injustice, it demonstrates the dedicated folks who serve us can work for good and appropriate policies.

Thank you because of the extensive periodic review conducted of 5-412 these regulations have been amended. VDH, OLC, the Attorney General, the Governor and the public determined this as necessary, now we can get back to the public health traditions that have served and continue to serve the Commonwealth so well. Science based best practices that respect the doctor and patient relationship are the benchmark for appropriate healthcare regulations.

Can anyone explain, as a wise person once asked,  " we trust women to have jobs, to vote, to serve in the military, to raise children, but when it comes to abortion, somehow women lose their brains and their moral agency?"  

"Once we can recognize that abortion and pregnancy loss is part of the natural circle of life as it always has been for 2000 years, we will speak from a place that naturally holds no judgment or battle lines... the goodness is inherent there... acknowledging that this experience may hold both joy and sorrow, relief and regret, love and loss, strength and vulnerability... to bring that reality forward, rather than have it twisted and turned to stigma, is speaking in a language for women and their families that frankly... is unassailable."

Am pleased to support the amendments though there is more needed, this is a good start.

Policy Director, Falls Church Healthcare Center

I support the approved amendments to the illegal and politically-motivated restrictions that violate women's access to comprehensive reproductive care in Virginia. The restrictions are nothing more than a sham that violate women's rights to reproductive choices. Virginia women will not tolerate political game-playing that mocks and undermines their reproductive freedom.

Thank you so much for supporting the women, men, and families in VA seeking abortion care. Thank you to the Governor and the VA Board for Health for not using a political agenda when addressing regulations for abortion care services and women's reproductive rights.  

Abortion is SAFE, LEGAL, and A RIGHT. 

Worldwide, nearly 22 million times a year, women use counterfeit drugs, quack doctors, tea-leaves, knitting needles, even small bottles filled with improvised explosives inserted into the uterus. And these are just some of the things that girls and women turn to in a desperate attempt to end their unintended pregnancies. 

Let's NOT go backwards, let's keep abortion care accessible to women, please.

Dear Dr. Levine and Board of Health Members,

The following is a comment submitted by the Virginia Coalition to Protect Women’s Health (“the Coalition”) regarding 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 members of the Coalition are health care providers and women’s health advocates. We support proven and medically sound regulations that genuinely advance the public health. 

Given the decisive ruling by the United States Supreme Court in Whole Woman’s Health v. Hellerstedt, 136 S. Ct. 2292 (2016), we call on the Virginia Department of Health (the “Department”) and the Board to support repeal of the Virginia statute that imposes hospital licensing requirements on abortion providers. These requirements are not justified by medical necessity and serve only to burden women by limiting access to safe, legal abortion care.

In the interim, we ask that the Department complete expeditiously the process of adopting the amendments to the regulations passed by the Board in October 2016, certified by the Attorney General in November 2016, and approved by Governor McAuliffe in January 2017.

We also incorporate by reference previous comments submitted by the Coalition that express our support for repeal or amendment of various other sections of the regulations for licensure of abortion facilities.

Until the state law is changed or set aside as unconstitutional, the approved amendments represent an important first step toward ensuring that the regulation of the Commonwealth’s abortion providers is in compliance with federal law and grounded in medical evidence – including conclusive medical evidence that abortion is one of the safest medical procedures provided in the United States.

The targeted regulation of abortion providers (“TRAP”) is one of over seventy-nine policy proposals advanced by Virginia lawmakers since 2010 intended simply to cut off Virginia women’s access to safe, legal reproductive health care, including abortion.

The Department currently possesses the critical opportunity to finalize the approved amendments to burdensome and unnecessary ideological regulations that were promulgated as a result of political pressure and over the objections of the medical community.

Health care providers in Virginia, including abortion providers, should be subject only to those laws and regulations that legitimately advance patient health and safety, that do not impose an undue burden on access to health care, and that are supported by more than mere political ideology. As the United States Supreme Court decisively ruled in Hellerstedt, laws and regulations targeting abortion providers that fail to advance patient health and safety in a manner “capable of withstanding any meaningful scrutiny” are presumptively invalid. 136 S. Ct. at 2319. Moreover, the Court ruled that, even in instances where a law or regulation legitimately confers a medical benefit, the benefit derived from the law or regulation must outweigh the burden on access to abortion that the law or regulation imposes. Id. at 2309-10, 2317-18. Accordingly, at the very least, the Board may not promulgate any regulation of abortion providers except to the extent that the medical benefit derived from the regulation, if any, outweighs the burden the regulation imposes. Virginia health care laws and regulations governing abortion must legitimately advance patient health and safety and ensure patients will have increased, not diminished, access to high-quality, essential reproductive health care services.

To that end, and in addition to the reasons articulated by the American Congress of Obstetricians and Gynecologists (“ACOG”) and the National Abortion Federation (“NAF”) in previous comments, we continue to express our opposition to the underlying law requiring first trimester abortion providers to meet hospital licensing rules, and our continued support for amending those portions of the current licensing regulations governing the design and construction of abortion facilities in the Commonwealth.

We note that medical experts, including ACOG and the American Medical Association, have concluded that there is absolutely no medical, health, or safety-related justification for requiring that first-trimester abortion procedures be provided in a setting equivalent to a hospital or ambulatory surgical center (“ASC”). We additionally note that the application of standards from the 2014 Guidelines for Design and Construction of Hospital and Outpatient Facilities of the Facility Guidelines Institute (commonly known as the “FGI Guidelines”), many of which are clearly intended to address issues that are only present in the context of surgical procedures requiring a sterile environment, are not medically appropriate for health centers providing abortion services.

This is especially true of facilities or offices in which only medication-induced abortion is performed. First-trimester abortion is a non-invasive, office-based, outpatient procedure that is safely provided in non-ASC medical offices throughout the country and in the Commonwealth.

Requiring providers that provide five or more abortions per month to adhere to hospital or ASC regulations, including design and construction requirements, does nothing to advance patient health and safety. Rather, it diminishes patient health and safety by forcing high-quality health care providers –especially those smaller businesses that are required to be protected against excessive government regulations placing an undue burden on small businesses -- to discontinue providing abortions – leaving Virginia women with continuously decreasing options to exercise their Constitutional right to access safe and legal abortion, particularly in less populated regions of the state.

The intent behind sham TRAP laws and regulations is clear and well-documented. In Virginia and across the country the purpose is simply to produce a de facto ban on abortion where legislators, thus far, have been unable to adopt unconstitutional bans outright by legislative fiat. This purpose is not only unconstitutional, it puts women’s lives and health at risk.

To keep women safe and prevent such health risks, the Department should promptly finalize the adopted amendments in the current licensing rules that reflect the medical reality that first-trimester abortion is one of the safest outpatient medical procedures performed in Virginia. We call on the Department to do so, thereby allowing implementation of changes to the existing licensing rules without delay.

We also call on the Board, the Department, the Attorney General, and the Governor to become leading advocates for the repeal of the underlying law that would eliminate the harm caused by sham TRAP laws and regulations, and protect and preserve a woman’s right to access a safe, legal abortion in the Commonwealth.

The Virginia Coalition to Protect Women’s Health is composed of the following entities and organizations:

ACLU of Virginia

Annandale Women and Family Center

Center for Reproductive Rights

Falls Church Healthcare Center

Feminist Majority Foundation

NARAL Pro-Choice Virginia

National Abortion Federation

Planned Parenthood Advocates of Virginia

Progress Virginia Education Fund

Richmond Medical Center for Women

Charlottesville Medical Center for Women

Peninsula Medical Center for Women

Roanoke Medical Center for Women

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

I am a social worker and native Virginian who supports the amendments to 12 VAC 5-412. For the past six years, I have helped many women access safe abortion care at Falls Church Healthcare Center. As a social worker, I am particularly interested in the intersecting emotional, physical and mental well-being of my clients. I believe this comprehensive well-being is largely achieved through evidence-based medicine and mental health care. I also believe, from both a professional and personal standpoint, that access to safe abortion care is vital to the citizens of this state.

Through my professional role I have unique insight into the comprehensive services our clinic offers. We help women access numerous services including prenatal care, birth control, breast cancer screenings and annual Well Woman Exams while training medical students and staying up to date on current evidence-based best practices. We also provide domestic violence, sexual assault and counseling resources many of our under resourced clients would never have otherwise received.

In my professional opinion, TRAP laws, such as the regulations that have plauged Virginia for too long now, do not keep women safe. We keep women safe. We respect them and care for them as if they are our own mothers, daughters, sisters, friends and partners. TRAP laws stigmatize Virginia women and make abortion inaccessible for those without without financial resources. We welcome guidelines crafted utilizing evidence-based medical information, not legislation geared towards making our services inaccessible to the women most in need of them.

The clients I have worked with are the reason I will always stand up for access to safe, affordable abortion care. Virginia policy makers should not see the women we work with as political statistics, victims or collateral damage in this debate. They are resilient people with unique journeys and infinite potential who have the right to determine their own destinies. It is time for Virginia to be on the right side of history and promptly adopt amendments to 12 VAC 5-412.

Emily Creveling, MSW

 

Dear Dr. Levine and Board of Health members:

This comment is submitted by legal advocates for the ACLU of Virginia, the Center for Reproductive Rights, Planned Parenthood Advocates of Virginia, the Falls Church Healthcare Center, and NARAL Pro-Choice Virginia.

In Virginia, there is not, and never has been, a proven, medically justifiable reason for regulating abortion providers in the same manner as hospitals.

Until 2011, abortion providers and their practices were regulated similarly to other physician groups and their practices. With the passage of the TRAP (“targeted regulation of abortion providers”) statute, Va. Code § 32.1-127(B)(1), in 2011, abortion providers were singled out for targeted, politicized regulations and restrictions by the Virginia Department of Health. These targeted restrictions have only one aim – to cut off access to safe, quality abortion care in Virginia by shutting down facilities in which abortion is provided, preventing physicians from providing first-trimester abortion care in their offices, and preventing the establishment of new  abortion care providers. Meanwhile, there is no proven reason grounded in patient health and safety for the Virginia Department of Health to license facilities in which abortion care is provided – alone among physician groups or medical offices – as a category of hospital.

In Whole Woman’s Health v. Hellerstedt, 136 S. Ct. 2292 (2016), the Supreme Court of the United States articulated a robust legal standard by which to evaluate laws regulating abortion, holding that such laws are unconstitutional when their burdens outweigh their proven medical benefits.

An abortion regulation that conveys no medical benefit would accordingly be unlikely to survive constitutional scrutiny under the undue burden balancing test.

In that case, the Court affirmed the following points of law:

1. “The ‘State has a legitimate interest in seeing to it that abortion, like any other medical procedure, is performed under circumstances that insure maximum safety for the patient.’”[1]
2. “[A] ‘statute which, while furthering [a] valid state interest, has the effect of placing a substantial obstacle in the path of a woman’s choice cannot be considered a permissible means of serving its legitimate ends.’”[2]
3. “‘[U]nnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on the right [to abortion].’”[3]

The Court also clarified that it is not enough for a state to assert that a law regulating abortion protects women’s health. The state must provide credible evidence that the law actually furthers women’s health.[4]

The Court further affirmed that, under the standard established in Casey, courts evaluating abortion regulations must “consider the burdens a law imposes on abortion access together with the benefits those laws confer.”[5] Under that standard, whatever (proven) medical benefit an abortion regulation may have must outweigh the burdens on access it creates for women.[6] If the law has no benefits, the constitutional analysis likely ends there.

The amendments 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”) seek to cure the current regulations’ most egregious and presumptively unconstitutional requirements. While the implementing statute, Va. Code § 32.1-127(B)(1), is itself presumptively unconstitutional, given the General Assembly’s refusal to repeal that statute we applaud the Board of Health, the Attorney General, and the Governor for taking this critical step to ensuring the regulations for licensed abortion facilities reflect medical evidence and do not infringe upon Virginians’ constitutional rights or threaten their health.

We incorporate by reference in this comment previous public comments submitted by our respective organizations during this regulatory action. Below we provide detailed explanations for why specific amendments approved during the October 2016 Board of Health meeting, and later certified by the Attorney General and approved by the Governor, would bring the relevant regulations into compliance with the constitutional standards reaffirmed and clarified in Whole Woman’s Health.

1. The approved amendments to 12 VAC 5-412-200(A), 350, 360, and 370 seek to cure the presumptive unconstitutionality of those provisions.  

Sections 200(A), 350, 360, and 370 impose cost-prohibitive and hospital-like design, construction, and operational standards on licensed abortion facilities. These standards are not medically necessary or intended to advance patient health and safety, but rather are intended to shut down abortion facilities by making it impossible or extremely difficult for them to comply. Because pre-viability abortion can be and is performed safely in an office-based setting, abortion facility regulations should not require adherence to any portion of the hospital design and construction standards outlined in the Facilities Guidelines Institute’s Guidelines for Design and Construction of Health Care Hospitals and Outpatient Facilities (2014 ed.), or other medically unnecessary provisions in Sections 200(A), 350, 360, and 370.

As the Supreme Court recently held in Whole Woman’s Health, there is no medical justification for – and patient health and safety is not advanced by – requiring pre-viability abortions to be performed in a hospital-like setting. 136 S. Ct. at 2316, 2318. The Court further clarified that, in particular, there is “no benefit” whatsoever to a surgical center requirement in the context of medication abortion. Id. at 2315. As explained above, a court considering whether a law places an undue burden on the right to abortion must analyze whether the asserted benefits of the law outweigh the burdens it places on access to abortion. Id. at 2309. Whole Woman’s Health specifically addressed Texas’s surgical center requirements, which were nearly identical to the provisions in Section 370. The Court struck down those requirements as unconstitutional, finding that imposing ambulatory surgical center standards on abortion providers (like Sections 200(A), 350, 360, and 370 at issue here) is medically unnecessary and the benefits do not outweigh the burdens they impose on the right to abortion. Id. at 2314-2316.

During this six-year regulatory process, no credible evidence has been presented proving there is a health or safety reason that first-trimester abortion – whether surgical or medication-based – must occur in the hospital-like setting required under Sections 200(A), 350, 360, or 370. In contrast, medical professionals have provided the Board with significant scientific evidence showing these provisions do not improve patient health and safety, and have instead imposed considerable burdens on access to abortion care in the Commonwealth. The evidence is clear that Sections 200(A), 350, 360, and 370 are unlikely to survive constitutional scrutiny under Whole Woman’s Health, and the approved amendments seek to cure those constitutional defects.

2. The approved amendments to 12 VAC 5-412-80 seek to cure the presumptive unconstitutionality of that provision.  

Section 80 currently prohibits the Health Commissioner from granting a licensed abortion facility a permanent waiver from complying with a burdensome regulation, even if such non-compliance would not put patient health or safety at risk. In contrast, the Health Commissioner has discretion to grant permanent waivers to other facilities regulated by the Department in which high-risk medical and surgical procedures are performed, such as in-patient hospitals. The approved amendments to Section 80 would render this provision identical to the “Allowable Variances” provision for hospitals, 412 VAC 5-410-30.

As explained above, abortion regulations that do not confer a proven medical benefit for patients and burden a woman’s ability to access abortion are constitutionally suspect under Whole Woman’s Health. While Section 80 currently confers no demonstrable, proven medical benefit to patients, it creates an obstacle to a patient seeking an abortion by (1) making it more difficult for new licensed abortion facilities to open in underserved areas (92 percent of Virginians live in counties without an abortion provider); (2) making it more difficult for physicians to incorporate abortion care into their existing practice; and (3) putting licensed abortion providers’ facilities at risk of losing their licenses each year.  

The current regulation imposes medically unnecessary procedural and administrative burdens on facilities in which five or more abortions are provided per month, without giving them the opportunity to apply for a waiver—an opportunity afforded to other facilities regulated by the Department. Any medical benefit derived from the deleted provisions in the approved amendments to Section 80 is outweighed by the burden on access they impose, and any purported health benefit is undermined by the fact that other facilities where much riskier procedures are performed may seek permanent waivers under Virginia law. Accordingly, these provisions do not meet the standard articulated by the Court in Whole Woman’s Health and are presumptively unconstitutional. By giving the Commissioner discretion to grant permanent waivers to all facilities regulated by the Department, including licensed abortion facilities, the approved amendments seek to cure the presumptive unconstitutionality of Section 80 while posing no risk to patient health.

3. The approved amendments to 12 VAC 5-412-100(C) seek to cure the presumptive unconstitutionality of that provision.   

Section 100(C) currently requires licensed abortion facilities to produce lists to the Department identifying patients treated at the facility during the previous 12 months before an inspection. This provision confers no medical benefits on patients and instead jeopardizes their privacy. This medically unnecessary requirement is unlikely to survive scrutiny under Whole Woman’s Health and the approved amendment to repeal it is appropriate.

4. The approved amendments to 12 VAC 5-412-130(A) and (B) seek to cure the presumptive unconstitutionality of those provisions.  

The approved amendments to Section 130 clearly demarcate which sections of the “Hospital and Nursing Home Licensure and Inspection” portion of the Virginia Code apply to abortion facilities. These technical amendments integrate Virginia Department of Health Office of Licensure and Certification (“OLC”) guidance into the regulation, and most were included in the Proposed Regulations and subject to public comment on multiple occasions.

The approved amendments to Sections 130(A) and (B) removing the requirement for compliance with Virginia Code § 32.1-132 (“Alterations or additions to hospitals and nursing homes”) are appropriate given the approved amendments to Section 370 of the regulations (which seek to bring that provision into compliance with federal law). This clarity will ensure abortion facilities have appropriate notice regarding the provisions of the law with which they must comply.

The approved amendments to Sections 130(A) and (B) would also remove the requirement for licensed abortion facilities to comply with Virginia Code § 32.1-137.01 (“Posting of charity care policies”). This requirement confers no proven medical benefit to patients, and is presumptively invalid under Whole Woman’s Health. Abortion providers, unlike hospitals, are not required to offer charity care. There is no proven medical benefit to patients in requiring abortion providers to advertise a service they neither offer nor are required by law to offer. This provision instead burdens access to abortion care in the Commonwealth by adding yet another administrative burden to licensed abortion facilities and discouraging physicians from incorporating abortion care into their office-based practices.

Requiring licensed abortion facilities to comply with Virginia Code § 32.1-137.01 is constitutionally suspect under Whole Woman’s Health because there is no proven medical benefit that outweighs the burden imposed on access to abortion. The approved amendment seeks to cure the presumptive unconstitutionality of this provision.

5. The approved amendment to 12 VAC 5-412-180(H) seek to cure the presumptive unconstitutionality of that provision.  

Section 180(H) currently allows the Department to remove from a licensed abortion facility personnel files containing personal information and identifiers. Allowing the Department to remove unredacted personnel files from a licensed abortion facility confers no proven medical benefit to patients. It instead discourages physicians, particularly those with privacy concerns, from incorporating first-trimester abortion care into their office-based medical practices and accordingly burdens a woman’s ability to access abortion care across the Commonwealth.

Any medical benefit derived from allowing the Department to remove personnel files from the facility is outweighed by the burden imposed on abortion access. This provision currently does not meet the standard articulated by the Court in Whole Woman’s Health. The approved amendment, however, seeks to remove the medically unnecessary burden by clarifying that any personnel files removed from the premises must first be redacted.

6. The approved amendments to 12 VAC 5-412-190(C) seek to cure the presumptive unconstitutionality of that provision.  

Section 190(C), as amended, would require a physician to assess the patient, determine whether the patient is safe for discharge, and, if the patient is safe for discharge, prepare a discharge order. It also requires a licensed health care practitioner trained in post-procedure assessment to remain on the premises until the last patient is discharged.

There has been no credible evidence produced during this regulatory process that there is an additional benefit to patient health and safety conferred by requiring the physician, who has already assessed the patient and prepared the discharge order, to remain on the premises with the licensed health care practitioner until the last patient physically leaves the facility. In fact, medical professionals have provided comments to the Board explaining that this provision is not only unnecessary to protect patient health and safety, it also reduces access to abortion by preventing the few licensed abortion facilities in the Commonwealth from employing physicians who can treat patients at multiple locations on the same day.

Abortion regulations that do not confer a proven medical benefit for patients and instead burden a patient’s ability to access abortion care are unlikely to survive constitutional challenge under Whole Woman’s Health. Section 190(C) currently burdens access to abortion across the Commonwealth, where 92 percent of Virginia localities do not have a licensed abortion facility. Any medical benefit derived from the current version of Section 190(C) requiring physician presence until the last patient physically leaves the facility is outweighed by the burden it imposes on abortion access. The approved amendment accordingly seeks to ensure Section 190(C) meets the constitutional standards required under Whole Woman’s Health.

7. The approved amendments to 12 VAC 5-412-290(B) and (C) seek to cure the presumptive unconstitutionality of those provisions.  

We support the approved amendments to Section 12 VAC 5-412-290 regarding emergency services. Not only is first trimester abortion extraordinarily safe, with complications in less than one percent of cases, but the vast majority of hospitals are required to treat patients in need of emergency care pursuant to the federal EMTALA (Emergency Medical Treatment and Labor Act). There is no medical or safety need for abortion facilities to have transfer agreements with hospitals. Under Whole Woman’s Health, a transfer agreement requirement would be closely scrutinized to ensure the burdens on access to abortion would not outweigh the benefits to women’s health.

Moreover, hospitals do not follow a standardized protocol when entering into transfer agreements. Rather, transfer agreement requirements vary. Hospitals may refuse to grant transfer agreement requests for reasons unrelated to patient care, such as political pressure. Further, the hospital with which a clinic has a transfer agreement may not be the closest emergency hospital to a woman experiencing complications post-procedure. This requirement accordingly would not serve any safety purpose for such women. See Whole Woman’s Health at 2315 (“complications [from medication abortion] would almost always arise only after the patient has left the facility.”).

The approved amendments to Section 290 – unanimously recommended by the physician advisory to the Board of Health – seek to bring these provisions into compliance with the standard articulated in Whole Woman’s Health and ensure medically unnecessary transfer agreement requirements are not imposed on licensed abortion facilities.

8. The approved amendment to 12 VAC 5-412-320(B)(5) seeks to cure the presumptive unconstitutionality of that provisions.  .

Section 320(B) requires licensed abortion facilities to report serious incidents affecting patient health or safety to OLC. Section 320(B)(5), however, requires licensed abortion facilities to disclose any incident reported to their medical malpractice insurer—regardless of whether the incident involved actual injury to a patient or staff member, or whether the report resulted in a claim. No evidence has been presented during this lengthy regulatory process indicating that reporting medical malpractice insurance claims confers a medical benefit to patients.

This provision burdens access to abortion care because the practice of filing fraudulent or nuisance claims against abortion facilities is an intimidation tactic used against patients attempting to access services at these facilities. See, e.g., http://www.slate.com/blogs/xx_factor/2016/08/25/pro_life_activists_sue_chicago_for_the_right_to_use_disturbing_tactics_outside.html. Medical malpractice insurance carriers may contractually require physicians or licensed healthcare providers to report any incident that may result in a medical malpractice complaint or lawsuit, regardless of the claim’s credibility or any actual harm caused to a patient (e.g., a patient’s baseless threat to sue his or her physician may qualify as an “incident” subject to mandatory reporting). There is no medical benefit associated with requiring such claims to be reported to OLC and subject to public release pursuant to FOIA laws.

Abortion regulations that do not confer a proven medical benefit to patients and instead burden access to abortion care do not pass constitutional muster under Whole Woman’s Health. Any medical benefit currently derived from Section 320(B)(5) is outweighed by the burden on access it imposes, and the approved amendment seeks to bring Section 320 in line with the constitutional requirements under Whole Woman’s Health.

9. The approved amendments to 12 VAC 5-412-330(1) and (2) seek to cure the presumptive unconstitutionality of those provisions.  

Sections 330(1) and (2) currently require licensed abortion facilities to produce to the Department records containing their facility security plans, including their safety-related information for employees and others using the facility. As such records are subject to FOIA requests, these provisions could jeopardize facility security, and therefore patient safety, should information about safety and security policies be released to the public.

No evidence has been presented during this lengthy regulatory process indicating Sections 330(1) and (2) confer a medical benefit to patients that is not outweighed by the burden on access they impose. Provisions that have not been proven to confer a medical benefit for patients and that burden a woman’s ability to access abortion do not meet the standard articulated by the Court in Whole Woman’s Health. There is no evidence in the record to demonstrate why it is medically necessary for facilities providing abortion care to comply with these provisions, or what medical benefit is afforded to their patients by requiring them to comply with these provisions. By imposing these administrative burdens only on facilities that provide abortion care, the state is discouraging physicians from incorporating first-trimester abortion care into their medical practices and silos abortion care into freestanding facilities that have long been targeted by anti-abortion violence. Accordingly, these provisions do not meet the standard articulated by the Court in Whole Woman’s Health and it is appropriate to repeal them.

Respectfully submitted by:

ACLU of Virginia

Center for Reproductive Rights

Planned Parenthood Advocates of Virginia

Falls Church Healthcare Center

NARAL Pro-Choice Virginia

 

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[1] 136 S. Ct. at 2309 (quoting Roe v. Wade, 410 U.S. 113, 150 (1973)).

[2] Id. (quoting Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833, 877 (1992) (plurality opinion)).

[3] Id. (quoting Casey, 505 U.S. at 878).

[4] See id,at 2309-10. 

[5] Id. (citing Casey, 505 U.S. at 887-98). 

[6] Id.