I. The Center for Reproductive Rights supports the majority of the proposed amendments to the current abortion regulations proposed by the Board of Health, and all of the proposed amendments to the current abortion regulations proposed by Governor McAuliffe.

We write to express support for the majority of the proposed Board of Health amendments to the regulations governing first trimester abortion provision, and to oppose two of these proposed amendments. We further write to express strong support for Governor Terry McAuliffe’s recommendations regarding these regulations.

The Center for Reproductive Rights (CRR) is a non-profit legal advocacy organization. In the United States, we have litigated cases in federal and state courts to ensure that governments at all levels do not infringe upon the constitutionally protected right of women to decide whether and when to bear children. We have successfully litigated several cases to prevent governments from imposing medically inappropriate regulations on abortion providers to the detriment of women seeking abortion care. Indeed, on June 27, 2016, in a challenge CRR brought on behalf of independent abortion providers in Texas, the U.S. Supreme Court struck down Texas restrictions similar to some of the existing regulations at issue in this comment that imposed medically unjustifiable requirements on abortion facilities.

The Board and the Governor’s proposed amendments will likely cure the presumptively unconstitutional requirement that abortion facilities conform to hospital-like building standards, as applied to existing first trimester facilities. See Whole Woman’s Health v. Hellerstedt, --- S.Ct. ----, 2016 WL 3461560, at *2 (2016) (holding that a law that regulates abortion is unconstitutional unless the medical benefits outweigh the burden on access to abortion, and specifically holding that Texas’s regulations requiring abortion clinics to conform to hospital-like standards are unconstitutional because they fail this balancing test.). We applaud the Board and Governor for taking steps to ensure these regulations reflect medical evidence and do not infringe upon women’s constitutional rights or threaten their health. Below we describe our support for proposed amendments to the regulations on abortion clinics regarding 1) medication abortion and construction requirements, 2) transfer agreements, 3) trimester dating, 4) referral and discharge, 5) hospital and nursing home licensure and inspection, and 6) medical testing, laboratory services, ectopic pregnancy, and documentation. We also describe our opposition to the Board of Health’s proposed amendments to trimester dating.

II. The Center for Reproductive Rights supports all proposed amendments concerning medication abortion and construction requirements, which better reflect the fact that there is no medical reason to regulate the provision of abortion differently than other office-based surgical or medical procedures.

The first trimester abortion procedure is a simple and extremely safe outpatient procedure that can be performed in a physician’s office. See Facts on Induced Abortion in the United States, Guttmacher Institute, https://www.guttmacher.org/fact-sheet/induced-abortion-united-states#9 (last updated May 2016). In fact, 95% of all abortion care is performed in outpatient facilities. See Rachel K. Jones and Kathryn Kooistra, Guttmacher Institute, Abortion Incidence and Access to Service in the United States, 2008, 43 Perspectives on Sexual and Reproductive Health, no. 1, at 42 (March 2011). The current regulations require compliance with sections of the Facilities Guidelines Institute (FGI) Guidelines for Design and Construction of Health Care Facilities (“the Guidelines”) pertaining to hospital design and construction. As the Supreme Court recently held, 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. Whole Woman’s Health v. Hellerstedt, --- S.Ct. ----, 2016 WL 3461560, at *36 (2016). The Supreme Court further ruled that in particular there is “no benefit” whatsoever to a surgical center requirement in the context of medication abortion. Id. at *30. The court clarified that determining whether or not a law is an undue burden on the right to abortion requires courts to analyze whether or not the asserted benefits of a law outweigh the burdens that law places on access to abortion. Id. at 21. The case specifically addressed Texas surgical center requirements similar to those in the Virginia regulations that are the subject of this comment, determined that these types of regulations unconstitutionally burden the right to abortion, and struck them down. Id. at *36.  

Imposing cost-prohibitive and hospital-like design and construction standards where these standards are not medically necessary is not intended to advance patient health and safety, but rather to shut down abortion facilities by making it impossible or extremely difficult for facilities 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 Guidelines.

There is no legitimate medical reason to regulate medication or surgical abortion differently than the provision of any other medication or similar office-based surgical procedure. Accordingly, these amendments may not cure the constitutional defect inherent to applying any portion of the Guidelines to facilities where pre-viability abortions are performed or provided. However, given the current statutory framework, we support the Board’s recommended amendment to Section 12VAC5-412-10 to separately define “medication induced abortion” and “surgical abortion” as well as their amendments to Section 12VAC5-412-370, regarding design and construction standards for abortion facilities. Further, we support Governor McAuliffe’s additional recommended amendments to Section 12VAC5-412-370. The Board’s recommendation and the Governor’s recommendation to require new abortion facilities to achieve minimal consistency with the Guidelines moves Virginia one step closer to bringing the regulations for the licensure of abortion facilities in line with the medical reality of first trimester abortion while staying within the Board’s statutory mandate. Similarly, the Board’s recommendation and the Governor’s recommendation that new medication-only abortion facilities achieve consistency with even fewer sections of FGI is an improvement. In short, there is no health or safety reason that first-trimester abortion – whether surgical or medication-based – must occur in a hospital-like setting, as recognized by the recent Supreme Court case of Whole Women’s Health v. Hellerstedt, which held that surgical center requirements for abortion clinics are presumptively unconstitutional.  Whole Woman’s Health v. Hellerstedt, --- S.Ct. ----, 2016 WL 3461560, at *36 (2016).

Both the Board and the Governor’s recommendations for design and construction are an important first step, given the Board’s statutory mandate, to bring the regulations for the licensure of abortion facilities in line with the medical reality and evidence-based practice of first trimester abortion.

III. The Center for Reproductive Rights supports the Board of Health’s proposed amendments concerning emergency services because they remove a medically unnecessary transfer agreement requirement.

We support the Board’s recommended amendments to Section 12VAC5-412-290 regarding emergency services. Not only is first trimester abortion extraordinarily safe, with complications in less than 1% of cases, but the vast majority of hospitals are required to take 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 the Supreme Court’s recent decision of Whole Woman’s Health v. Hellerstedt, a transfer agreement requirement would be closely scrutinized to ensure the burdens on access to abortion did not outweigh the benefits to women’s health. See Whole Woman’s Health v. Hellerstedt, --- S.Ct. ----, 2016 WL 3461560, at *21 (2016).

Moreover, hospitals do not follow a standardized protocol when entering into transfer agreements – rather, transfer agreement requirements vary. In fact, hospitals may refuse to grant transfer agreement requests for reasons unrelated to patient care, such as political pressure. Finally, the hospital with which a clinic has a transfer agreement may not be the closest emergency hospital to a woman experiencing complications post-procedure, so this requirement would not serve any safety purpose for such women.  See WWH v. Hellerstedt, --- S.Ct. ----, 2016 WL 3461560, at *30 (“complications [from medication abortion] would almost always arise only after the patient has left the facility.”).

Thus, this amendment – unanimously recommended by the physician advisory to the Board of Health – would help ensure that medically unnecessary transfer agreement requirements are not imposed on first trimester abortion clinics.

IV. The Center for Reproductive Rights opposes the Board of Health’s proposed amendments regarding trimester dating, and supports Governor McAuliffe’s proposed amendments to date pregnancy in a more medically accurate manner.

Abortion regulations, like any regulation of medical procedures, should be evidence-based and medically appropriate. Therefore, we oppose the Board of Health’s recommended amendments defining the first trimester of pregnancy. Specifically, we are opposed to the recommended amendment to Section 12VAC5-412-10 stating that the “first trimester” of pregnancy be defined as “the first 12 weeks from conception as determined in compliance with § 18.2-7.6 of the code of Virginia[,]” as well as the Board of Health’s recommended amendment to Section 12VAC5-412-230(A), stating that “[a]bortions performed in abortion facilities shall be performed only on patients who are within the first trimester of pregnancy based on an appropriate clinical estimate by a licensed physician as determined in compliance with § 18.2-7.6 of the Code of Virginia.”

We oppose these amendments because “12 weeks from conception” is a technically inferior measure of the end of the first trimester of pregnancy, both in terms of the way a pregnancy is dated (“12 weeks”) and the unit of measurement for that date (“from conception”). In the practice of medicine, pregnancy is measured in days or weeks from the first day of a woman’s last menstrual period (LMP) – not from conception – and totaling 40 weeks. Cf. Planned Parenthood of Central Florida. v. Philip, Case No. 4:16cv321-RH/CAS, at *19-21 (N.D. Fla. June 30, 2016) (describing how medical professionals measure gestational age from LMP, and finding “no medical justification” for defining the last day of the first trimester other than as 13 weeks, 6 days LMP.. “Conception” is also not a medical term and is not generally used by medical professionals to date or measure pregnancy. Cf. id. Moreover, Code § 18.2-76 is irrelevant to the definition of “first trimester” as it does not address how to date pregnancy; it should not be referenced for that purpose.

Instead, we support Governor Terry McAuliffe’s recommendation for Section 12VAC5-412-230 that the “first trimester” of pregnancy be defined as “13 weeks and 6 days after last menstrual period or based on an appropriate clinical estimate by a licensed health care provider.” It is generally accepted that the first trimester ends at 13 weeks 6 days LMP. The National Abortion Federation’s Clinical Policy Guidelines refer to the 2nd trimester as “more than 14 weeks from LMP.” See National Abortion Federation, Clinical Policy Guidelines, Standard 10.2, 27 (2016). There are also a number of medical journals which reference 14 weeks LMP as the first trimester. See, e.g., Frances Casey, et al., A Randomized Controlled Trial Evaluating Same-Day Mifepristone and Misoprostol Compared to Misoprostol alone for Cervical Preparation prior to Second-Trimester Surgical Abortion, Contraception 87 (accepted manuscript 2016) (defining second-trimester as after 14 weeks LMP); Matthew Reeves, et al., Doxycycline serum levels at the time of dilation and evacuation with two dosing regimens, Contraception 79, 129-133 (2009) (defining the beginning of second trimester as 15 weeks LMP).

Moreover, while the regulations currently provide for a clinical “estimate by a licensed physician,” health care providers other than physicians are capable of dating, and often do date, pregnancies. Therefore, the Governor’s amendment is more medically accurate than the current amendment proposed by the Board of Health, and should be included in the final regulations.

V. The Center for Reproductive Rights supports the Board of Health’s proposed amendments concerning referral and discharge. 

We support the Board’s recommended amendment to Section 12VAC5-412-230(E): “The abortion facility shall offer each patient seeking an abortion, in a language or manner she understands, appropriate counseling and instruction in the abortion procedure and shall develop, implement, and maintain policies and procedures for the provision of or referral for family planning and post abortion counseling services to its patients.”

We further support the Board’s recommended amendment to Section 12VAC5-412-230(F): “There shall be an organized discharge planning process that includes an evaluation of the patient’s capacity for self-care and an assessment of a patient’s safety for discharge and discharge instructions for patients to include instructions to call or return if signs of infection develop.”

These amendments were unanimously recommended by the physician advisory panel to the Board of Health.

VI. The Center for Reproductive Rights supports the Board of Health’s proposed amendments concerning hospital and nursing home licensure and inspection due to increased clarity for compliance. 

We support the Board’s recommended amendment to Section 12VAC5-412-130 to clearly demarcate which sections of the “Hospital and Nursing Home Licensure and Inspection” portion of the Virginia Code apply to abortion facilities. This clarity will be important to ensure abortion facilities have appropriate notice regarding which provisions of the law they must comply with.

VII. The Center for Reproductive Rights supports the Board of Health’s proposed amendments concerning medical testing, laboratory services, ectopic pregnancy, and documentation.

Finally, we support the Board’s recommended amendments to Section 12VAC5-412-240 regarding medical testing, laboratory services, and ectopic pregnancy. We further support the Board’s recommended amendments to Section 12VAC5-412-250 regarding documentation of anesthesia services in the patient record.

These amendments were unanimously recommended by the physician advisory panel to the Board of Health.

VIII. Conclusion

The Center for Reproductive Rights thanks you for taking the time to review our comments, and for amending the regulations to better reflect the medical reality of first trimester abortion care. We urge you to adopt all the Governor’s recommendations and the Board amendments that we list above as supporting.