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.