background on targeted regulations and falls church healthcare center's lawsuit

7/27/2019 Background on Targeted Regulations and Falls Church Healthcare Center's Lawsuit

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Falls Church Medical Center vs. Virginia Board of Health and VirginiaDepartment of Health

Hearing to Start October 9, 2013, 10:00amArlington 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 womenshealth care centers with medically unnecessary financial burdens that threaten their veryexistence. Since these regulations went into effect on June 20, 2013, two womens health carecenters in Virginia have been shuttered. Unless these regulations are found to be unlawful, theCommonwealths remaining 18 abortion providers could be forced to close in as little as 6months denying thousands of women access to their legal and needed medical care. Theeffects SB 924 depend largely on the regulations spawned under the law andpromulgated by the Board of Health and adopted by the McDonnell Administration. If these regulations had been based upon evidence-based medical practices thatadvance the public health, then the women in the Commonwealth could havemaintained access to vital health care from trusted medical providers. If, however,

political motives and ideological passions interfered in the regulatory process, thenthe safety of womens health will be jeopardized. Because of these concerns, FallsChurch 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 outabortion providers. Abortion should not be regulated differently than other outpatientprocedures that are safely provided in doctors offices and non-hospital medical facilities.While Senate Bill 924 established that facilities performing five or more first trimesterabortions 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 hospitalsor 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 highercomplication rates than abortion.

(2)Regulations rejected by Virginias doctors and its residents: This is a policy thathas 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 areunnecessary for ensuring safe first-trimester abortion services.

Medical Professionals overwhelming opposed the regulations, input the Board of Healthignored. 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 reviewthe draft regulations in 2011, publicly denounced the final regulations, andcalled them politically motivated, saying that arbitrary and capriciousdecisions like this in my opinion have no place in the practice of medical careand disruption thats occurringwomens health care should not be politically
http://www.wjla.com/articles/2011/12/medical-experts-virginia-abortion-regulations-based-on-politics-not-safety-69899.htmlhttp://www.wjla.com/articles/2011/12/medical-experts-virginia-abortion-regulations-based-on-politics-not-safety-69899.htmlhttp://www.nbc29.com/story/18794646/uva-gynecologist-speaks-out-ahead-of-abortion-regulation-approval?clienttype=printablehttp://www.wjla.com/articles/2011/12/medical-experts-virginia-abortion-regulations-based-on-politics-not-safety-69899.htmlhttp://www.wjla.com/articles/2011/12/medical-experts-virginia-abortion-regulations-based-on-politics-not-safety-69899.htmlhttp://www.nbc29.com/story/18794646/uva-gynecologist-speaks-out-ahead-of-abortion-regulation-approval?clienttype=printable


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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 March29, 2013, stating that the regulations have nothing to do with patient careand safety.

o In September 2012, a diverse group of doctors and medical experts from acrossthe state organized and independently funded a public letter and RichmondTimes-Dispatch advertisement , writing that We must not travel down adangerous slippery slope where we allow political forces to dictatemedical care.

o In October 2012, Dr. Karen Remley, the Virginia Health Commissioner, resignedher position due to the intrusion of politics into womens health care. Dr. Remleysent a final letter to the Board of Health in April, pleading with the body to do theright thing and reject these regulations.

Virginians overwhelming opposed the proposed regulations, input the Board of Healthignored. Even though the public comment period was truncated (see history of flawedprocess below), the final public comments on the official Virginia Townhall websiteshow that strong majorities of people oppose the regulations: Of the total 5,921 publiccomments, 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 themost restrictive state abortion regulations in the country.

Background on Falls Church Healthcare Administrative Appeal

Falls Church Healthcare (FCHC) is arguing that these regulations represent governmentoverreach to advance a social agenda unrelated to medical standards of care. FCHC seeks tohave a court of law declare the onerous regulations to be a violation of long establishedprinciples of Virginia State law that require fundamental fairness by state agencies.

Government leaders say they are supporters of small businesses, including serviceproviders. Falls Church Healthcare is such a small business. It provides a full range of OB-GYN services to women. Many of those women have no insurance or are of limitedfinancial means. Without options like Falls Church Healthcare, women will face moreexpensive 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 whensmall 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 in-patient hospitals only have to comply with the new construction standards when a newhospital is constructed or an existing hospital is substantially renovated.

The State Board of Health is under a legislative command to adopt rules in substantialconformity to the standards of health, hygiene, sanitation, construction and safety asrecognized by medical and health care professionals and by specialists in public healthand safety including provisions of federal law on health care. They were pressured bywrong-headed guidance from the attorney general to ignore healthcare professionalsadvice

The General Assembly in 2011 did not command the State Board of Health to apply in-patient hospital construction standards to existing fully licensed clinics like Falls ChurchHealthcare.
http://townhall.virginia.gov/L/viewcomments.cfm?commentid=27735https://acluva.org/wp-content/uploads/2013/10/FInal-Med-Prof-Letter-BOH-RTD.pdfhttps://acluva.org/wp-content/uploads/2013/10/FInal-Med-Prof-Letter-BOH-RTD.pdfhttps://acluva.org/wp-content/uploads/2013/10/FInal-Med-Prof-Letter-BOH-RTD.pdfhttps://acluva.org/wp-content/uploads/2013/10/FInal-Med-Prof-Letter-BOH-RTD.pdfhttps://acluva.org/wp-content/uploads/2013/10/FInal-Med-Prof-Letter-BOH-RTD.pdfhttp://www.usatoday.com/story/news/ondeadline/2012/10/18/virginia-health-commissioner-resigns/1642197/http://www.usatoday.com/story/news/ondeadline/2012/10/18/virginia-health-commissioner-resigns/1642197/http://www.vdh.state.va.us/administration/meetings/documents/2013/pdf/Agenda%20to%20be%20posted.pdfhttp://www.timesdispatch.com/opinion/their-opinion/columnists-blogs/guest-columnists/whose-small-business-may-be-next/article_8e781c24-c10e-501a-a12c-fbbff81c0330.htmlhttp://townhall.virginia.gov/L/viewcomments.cfm?commentid=27735https://acluva.org/wp-content/uploads/2013/10/FInal-Med-Prof-Letter-BOH-RTD.pdfhttps://acluva.org/wp-content/uploads/2013/10/FInal-Med-Prof-Letter-BOH-RTD.pdfhttp://www.usatoday.com/story/news/ondeadline/2012/10/18/virginia-health-commissioner-resigns/1642197/http://www.usatoday.com/story/news/ondeadline/2012/10/18/virginia-health-commissioner-resigns/1642197/http://www.vdh.state.va.us/administration/meetings/documents/2013/pdf/Agenda%20to%20be%20posted.pdfhttp://www.timesdispatch.com/opinion/their-opinion/columnists-blogs/guest-columnists/whose-small-business-may-be-next/article_8e781c24-c10e-501a-a12c-fbbff81c0330.html


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Professionals advising the Board unanimously agreed that making existing facilities comeup to in-patient hospital standards bore no logical connection to the services provided byfacilities like Falls Church Healthcare; that such actions would cause these smallbusinesses to cease operation; and that families would be hurt if this health care choicewere removed.

FCHC is concerned about political motivations. There are legitimate and well-foundedconcerns that Attorney General Cuccinelli, Governor McDonnell, and his Administration are

using the regulatory process in pursuit of a political agenda that undermines the healthand safety of women in Virginia. They wield unchecked control over the emergencyprocess and permanent process of rule making. Any negative outcomes resulting fromburdensome regulations will ultimately be their burden to bear.

The Board attempted to follow these standards and enact a grandfather clause in the draftpermanent regulations that would have allowed existing facilities to continue to operateprovided they met state and local building codes, but the Attorney General erroneouslyrejected this effort. Because of the Attorney Generals erroneous legal guidance, the Boardwithdrew the grandfather clause. Additionally, the Attorney General, in no uncertainterms, informed Board of Health members that they would not be represented in any legalsuits by his office if they did not adopt the regulations un-amended. Attorney GeneralCuccinelli pressured the Board behind the scenes .

Attorney General Ken Cuccinellis office has filed a motion to dismiss Falls Church Healthcaresadministrative appeal. On October 9 th at 10:00am, a judge will hear this motion and decidewhether 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. Theyalready meet the same standards as other doctors offices that perform office-basedsurgeries. It is not only inequitable, but it is harmful to play politics with womens healthand safety.

Early abortion care is difficult to access in the Commonwealth. 85% of Virginias countieslack any abortioncare services.

Abortion providers in Virginia offer an array of reproductive healthcare services to womenas well as men, including preventive reproductive healthcare services such as life-savingcancer screenings, family planning, and STI testing and treatment, as well as earlyabortion.

First-trimester abortions remain one of the safest and most common of all in-officeprocedures.

History of Board of Healths Flawed Rule Making

Though unwarranted, the new law required that regulations be issued on an emergencybasis, thus depriving the public of its full right to weigh in on any proposed regulations andreducing 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 pacedtimeline to enact emergency regulations within 280 days of the governor signing the bill.

This truncated process significantly reduced the opportunities for public involvement thatare normally included as an essential part of the regulatory process. The draft regulationsproposed on September 1, 2011 permitted the public only two weeks to provide commentsto the Board prior to, and only twenty minutes for comments during the hearing at whichthe Board voted on the regulation.
http://hamptonroads.com/2012/09/cuccinelli-issues-warning-over-abortion-ruleshttp://hamptonroads.com/2012/09/cuccinelli-issues-warning-over-abortion-rules


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The draft regulations voted on by the Board went to the Governor, Attorney General, andSecretary of Health for executive review. There is no period for public comment after theexecutive review.

The permanent regulations process began not anew, but based on the emergencyregulations in effect. This process was as equally flawed as the truncated emergencyprocess 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 smallbusiness, they did not accommodate the effects on the family, and they do not meetfederal rules that require fist trimester abortions to be performed in outpatient facilities inorder to receive Medicare and Medicaid reimbursement. The Attorney General filed amotion to dismiss FCHCs appeal, which is being argued on October 9, 2013 in CircuitCourt.

background on targeted regulations and falls church healthcare center's lawsuit

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