Falls Church Medical Center vs.

Virginia Board of Health and Virginia Department of Health Hearing to Start October 9, 2013, 10:00am Arlington Circuit Court
After a two-year saga, the Virginia Board of Health voted on April 12, 2013, to impose onerous new regulations on womens health care centers that provide safe, legal first-trimester abortions. These regulations are designed not to promote better health care, but rather to saddle womens health care centers with medically unnecessary financial burdens that threaten their very existence. Since these regulations went into effect on June 20, 2013, two womens health care centers in Virginia have been shuttered. Unless these regulations are found to be unlawful, the Commonwealths remaining 18 abortion providers could be forced to close in as little as 6 months denying thousands of women access to their legal and needed medical care. The effects SB 924 depend largely on the regulations spawned under the law and promulgated by the Board of Health and adopted by the McDonnell Administration. If these regulations had been based upon evidence-based medical practices that advance the public health, then the women in the Commonwealth could have maintained access to vital health care from trusted medical providers. If, however, political motives and ideological passions interfered in the regulatory process, then the safety of womens health will be jeopardized. Because of these concerns, Falls Church Healthcare Center filed the legal Appeal in June of 2013.

Background on Virginia Targeted Regulations

(1)Discriminatory regulation: There are no legitimate medical purposes for singling out abortion providers. Abortion should not be regulated differently than other outpatient procedures that are safely provided in doctors offices and non-hospital medical facilities. While Senate Bill 924 established that facilities performing five or more first trimester abortions were to be a class of hospital, the Board of Health could have regulated them as it does other outpatient medical facilities. But it did not and that is wrong. The hospital building requirements have not been applied to any existing hospitals or to any other outpatient services provided in Virginia, including vasectomies, dental procedures, liposuction and other cosmetic procedures; these are comparable minimally-invasive procedures, performed in an office, with higher complication rates than abortion.

(2)Regulations rejected by Virginias doctors and its residents: This is a policy that has been denounced by the Virginia medical community and the overwhelming majority of Virginia residents. Health care experts agree that extensive architectural, procedural, staffing, and equipment requirements will not improve womens health and safety and are unnecessary for ensuring safe first-trimester abortion services. Medical Professionals overwhelming opposed the regulations, input the Board of Health ignored. Over 200 doctors have publicly denounced the regulations over the past year. o In June 2012, Dr. James Jef Ferguson of the University of Virginia School of Medicine, one of six top medical experts from across Virginia, asked to review the draft regulations in 2011, publicly denounced the final regulations, and called them politically motivated, saying that arbitrary and capricious decisions like this in my opinion have no place in the practice of medical care and disruption thats occurringwomens health care should not be politically

motivated. He asked for his name to be removed from the final regulations. Dr. Ferguson contributed a public comment to the Virginia Townhall site on March 29, 2013, stating that the regulations have nothing to do with patient care and safety. o In September 2012, a diverse group of doctors and medical experts from across the state organized and independently funded a public letter and Richmond Times-Dispatch advertisement, writing that We must not travel down a dangerous slippery slope where we allow political forces to dictate medical care. o In October 2012, Dr. Karen Remley, the Virginia Health Commissioner, resigned her position due to the intrusion of politics into womens health care. Dr. Remley sent a final letter to the Board of Health in April, pleading with the body to do the right thing and reject these regulations. Virginians overwhelming opposed the proposed regulations, input the Board of Health ignored. Even though the public comment period was truncated (see history of flawed process below), the final public comments on the official Virginia Townhall website show that strong majorities of people oppose the regulations: Of the total 5,921 public comments, 81 percent (4,796) oppose the regulations, and only 19 percent (1,125) approve. (Final tally available on Virginia Townhall website.)

The regulations, which have not been endorsed by medical experts or supported by the public, severely limit access to legal, safe first-trimester abortion in Virginia, and represent some of the most restrictive state abortion regulations in the country.

Background on Falls Church Healthcare Administrative Appeal

Falls Church Healthcare (FCHC) is arguing that these regulations represent government overreach to advance a social agenda unrelated to medical standards of care. FCHC seeks to have a court of law declare the onerous regulations to be a violation of long established principles of Virginia State law that require fundamental fairness by state agencies. Government leaders say they are supporters of small businesses, including service providers. Falls Church Healthcare is such a small business. It provides a full range of OBGYN services to women. Many of those women have no insurance or are of limited financial means. Without options like Falls Church Healthcare, women will face more expensive and possibly unsafe medical options. Like other state agencies, the State Board of Health is under an Executive Order of Governor McDonnell to use the least costly and least invasive means of regulation when small businesses are impacted. Cost/benefit analyses for state regulations are required. None were completed. The construction standards for hospitals in Virginia have been in place since 1948, and inpatient hospitals only have to comply with the new construction standards when a new hospital is constructed or an existing hospital is substantially renovated. The State Board of Health is under a legislative command to adopt rules in substantial conformity to the standards of health, hygiene, sanitation, construction and safety as recognized by medical and health care professionals and by specialists in public health and safety including provisions of federal law on health care. They were pressured by wrong-headed guidance from the attorney general to ignore healthcare professionals advice The General Assembly in 2011 did not command the State Board of Health to apply inpatient hospital construction standards to existing fully licensed clinics like Falls Church Healthcare.

Professionals advising the Board unanimously agreed that making existing facilities come up to in-patient hospital standards bore no logical connection to the services provided by facilities like Falls Church Healthcare; that such actions would cause these small businesses to cease operation; and that families would be hurt if this health care choice were removed. FCHC is concerned about political motivations. There are legitimate and well-founded concerns that Attorney General Cuccinelli, Governor McDonnell, and his Administration are using the regulatory process in pursuit of a political agenda that undermines the health and safety of women in Virginia. They wield unchecked control over the emergency process and permanent process of rule making. Any negative outcomes resulting from burdensome regulations will ultimately be their burden to bear. The Board attempted to follow these standards and enact a grandfather clause in the draft permanent regulations that would have allowed existing facilities to continue to operate provided they met state and local building codes, but the Attorney General erroneously rejected this effort. Because of the Attorney Generals erroneous legal guidance, the Board withdrew the grandfather clause. Additionally, the Attorney General, in no uncertain terms, informed Board of Health members that they would not be represented in any legal suits by his office if they did not adopt the regulations un-amended. Attorney General Cuccinelli pressured the Board behind the scenes.

Attorney General Ken Cuccinellis office has filed a motion to dismiss Falls Church Healthcares administrative appeal. On October 9th at 10:00am, a judge will hear this motion and decide whether or not to grant the case a full trial.

Background on Virginias Womens Health Centers

Womens health centers in Virginia support the highest standards of care for women. They already meet the same standards as other doctors offices that perform office-based surgeries. It is not only inequitable, but it is harmful to play politics with womens health and safety. Early abortion care is difficult to access in the Commonwealth. 85% of Virginias counties lack any abortioncare services. Abortion providers in Virginia offer an array of reproductive healthcare services to women as well as men, including preventive reproductive healthcare services such as life-saving cancer screenings, family planning, and STI testing and treatment, as well as early abortion. First-trimester abortions remain one of the safest and most common of all in-office procedures.

History of Board of Healths Flawed Rule Making

Though unwarranted, the new law required that regulations be issued on an emergency basis, thus depriving the public of its full right to weigh in on any proposed regulations and reducing the time for the Board of Health to consider comments by medical professionals, public health experts, and the general public. The Board instead had to follow a fast paced timeline to enact emergency regulations within 280 days of the governor signing the bill. This truncated process significantly reduced the opportunities for public involvement that are normally included as an essential part of the regulatory process. The draft regulations proposed on September 1, 2011 permitted the public only two weeks to provide comments to the Board prior to, and only twenty minutes for comments during the hearing at which the Board voted on the regulation.

The draft regulations voted on by the Board went to the Governor, Attorney General, and Secretary of Health for executive review. There is no period for public comment after the executive review. The permanent regulations process began not anew, but based on the emergency regulations in effect. This process was as equally flawed as the truncated emergency process and one basis of Falls Church Healthcare Centers (FCHC) Administrative Appeal. Further, the regulations are not based on medical science and public health. They are arbitrary, they do not comply with the requirement that less costly rules be used for small business, they did not accommodate the effects on the family, and they do not meet federal rules that require fist trimester abortions to be performed in outpatient facilities in order to receive Medicare and Medicaid reimbursement. The Attorney General filed a motion to dismiss FCHCs appeal, which is being argued on October 9, 2013 in Circuit Court.