SUBMITTED VIA MAIL AND EMAIL
September 22, 2008
Denise M. Burke
Vice President & Legal Director
Americans United for Life
310 S. Peoria St, Suite 500
Chicago, IL 60607
Office of Public Health and Science
Department of Health and Human Services
Attn: Brenda Destro
Hubert H. Humphrey Building
200 Independence Avenue SW, Room 728E
Washington DC 20201
To whom it may concern:
On August 26, 2008, the Department of Health and Human Services (hereinafter, “HHS”) published and solicited public comment on a proposed regulation1 that would implement and strengthen the enforcement of existing federal laws2 protecting the freedom of conscience of healthcare providers nationwide. In response, Americans United for Life (AUL), a nonprofit, public-interest law and policy organization whose vision is a nation in which every human being is welcomed in life and protected in law, submits the enclosed comments in support of the need for the proposed regulation.
AUL affirms that the proposed regulation is simply a much-needed enforcement mechanism for existing federal laws protecting healthcare freedom of conscience and argues that the failure to adequately protect conscience – through both appropriate laws and requisite enforcement mechanisms – will only exacerbate the existing healthcare crisis in this country.
Finally, in light of the contrived controversy instigated by pro-abortion advocates over the scope and impact of the proposed regulation, AUL urges HHS to consider adding precise and well-vetted definitions to the proposed regulation including a medically and legally appropriate definition of “abortion.” While the purpose and intent of the proposed regulation is abundantly clear, we believe that adding suitable definitions will help to mitigate the existing controversy and assist in the ultimate implementation of the proposed rule.
The Need to Protect Healthcare Freedom of Conscience3
Often thought of as a contemporary problem, the issue of freedom of conscience was referenced and considered by our Founding Fathers. For example, Thomas Jefferson wrote, “No provision in our Constitution ought to be dearer to man than that which protects the rights of conscience against the enterprises of the civil authority.” Moreover, traditional western thought has understood that individual conscience is a guide for action and is indispensable to appropriate action.
In the ongoing debate over the freedom of conscience of healthcare providers, misinformation and hyperbole abound. However, a full and fair debate of the issue requires an understanding that:
Freedom of conscience protections affirm the need to provide quality care to patients and do not interfere with existing medical malpractice standards. They merely acknowledge that certain demands of patients, usually for procedures that are life-destructive and not life-saving, must not be blindly accommodated to the detriment of the freedom of healthcare providers.
Individuals and institutions do not lose their right to exercise their moral and religious beliefs and conscience once they decide to become healthcare providers. Nothing in the laws protecting healthcare rights of conscience prevent others from providing the healthcare service to which a conscientious objection has been made.
Importantly, conscientious objections are most often raised concerning elective services, such as abortion, contraception, sterilization, physician-assisted suicide, and withdrawal of nutrition and hydration, rather than necessary or lifesaving services. Therefore, the lack of participation in these practices by a healthcare provider or institution will not endanger the lives or health of patients.
Finally, those who oppose the proposed regulation, primarily pro-abortion advocates and groups, are increasingly couching their arguments with references to women’s right to healthcare access including access to contraception. However, the use of the term “access” is a red herring, as there is no real problem, when a conscientious objection is made, with a patient going to another (willing) healthcare provider for service. However, if the proposed regulation is not implemented and opponents succeed in blocking this and other protections of conscience, there will be an exacerbation of the current healthcare crisis.
Proposed Regulation Avoids Aggravating America’s Current Healthcare Crisis
Protecting the freedom of conscience of healthcare professionals and institutions is necessary to avoid added stress on an already overtaxed healthcare system. Experts project that current shortages of physicians, nurses, and other healthcare professionals will worsen, failing to meet future requirements. Legal action and other pressure to compel healthcare providers to participate in procedures to which they conscientiously object threaten to make the already dangerous situation disastrous. By forcing healthcare professionals to choose between conscience and career, we will lose doctors, nurses, and other healthcare professionals who are already in short supply, especially in rural parts of the country. We will also effectively bar competent young men and women, desperately needed, from entering these vital professions.
Hospitals, clinics, and pharmacies will disappear if owners and board members are forced by law to provide procedures and prescriptions against their conscience in order to stay in business. Without a doubt, the health of the nation demands protecting individual freedom of conscience.
Many women have already experienced first-hand the current provider shortage, having a hard time finding obstetricians to deliver their babies. In 2006, 14 percent of ACOG members reported that they had stopped delivering babies.4 Further, the American Association of Medical Colleges (AAMC) projects an anticipated physician shortfall of 70,000 or more by 2025.5
As troubling as these predictions are, the nursing shortage is even worse. Some studies predict the shortage of registered nurses in the U.S. will reach 500,000 by 2025.6 Health Resources and Services Administration (HRSA) officials have projected the nation’s nursing shortage will grow to more than one million nurses by 2020, and analysts show that all 50 states will experience a shortage of nurses to varying degrees by the year 2015 – just seven years from now.7
According to a July 2007 report released by the American Hospital Association, U.S. hospitals need approximately 116,000 RNs to fill current vacant positions nationwide.8 Moreover, over half of the surveyed nurses reported that they intended to retire between 2011 and 2020.9 The Council on Physician and Nurse Supply10 has determined that 30,000 additional nurses must graduate annually to meet the nation’s emerging healthcare needs, an expansion of 30% of the current number of annual nurse graduates.
Insufficient staffing raises stress levels, impacts job satisfaction, and is driving many to leave nursing.11 Many recent studies also point to the connection between adequate staffing and safe patient care.12 Increases in registered nurse staffing was associated with reductions in hospital-related mortality and “failure to rescue,” as well as reduced length of stays; conversely, in settings with inadequate staffing, patient safety was compromised.13 Most hospital RNs (93%) report major problems with having enough time to maintain patient safety, detect complications early, and collaborate with other healthcare team members. 14
More nurses at the bedside could save thousands of patient lives each year.15 Patients who have common surgeries in hospitals with high nurse-to-patient ratios have an up to 31% increased chance of dying.16 Every additional patient in an average hospital nurse's workload increased the risk of death in surgical patients by 7%.17 Having too few nurses may actually cost more money given the high costs of replacing burnt-out nurses and caring for patients with poor outcomes.
To slow – and not exacerbate – these shortages, there is a need for comprehensive conscience protections and proper enforcement of existing federal and state laws.18 Protecting freedom of conscience does not ban any procedure or prescription and does not mandate any particular belief or morality. Freedom of conscience simply provides American men and women the guarantees that this country was built upon: the right to be free from coercion. Protecting conscience helps ensure that providers enter and remain in the healthcare professions, helping to meet the rising demand for quality healthcare. Failing to do so will compromise basic healthcare for the entire nation.
Manufactured Controversy Over Proposed Regulation Suggests Need to Include Medically and Legally Appropriate Definitions
Having reviewed the proposed regulation and a variety of medical and legal resources, we recommend that HHS consider including a medically and legally appropriate definition of “abortion” in the proposed regulation and, in conjunction, consider adding definitions for some important and related terms. Precise and simple definitions may dissipate some of the manufactured controversy over the proposed regulation, clarify the scope of the rule, and lessen the chances of unanticipated problems with implementation.
Importantly, the purported controversy surrounding the proposed regulation has been generated predominantly by those who support unrestricted abortion-on-demand and federal funding of both abortion and family planning. The crux of their arguments is that HHS, by issuing the proposed regulation, is somehow ignoring or changing accepted medical definitions (such as the definition of “abortion”) and potentially interfering with women’s access to contraception and other medical care.
However, a brief review of history aptly demonstrates that it is abortion advocates and their allies who have long sought to change accepted medical definitions to support their politically-motivated agendas and who are, even in this context, seeking to further these agendas by advancing inaccurate arguments about the intent and impact of the proposed regulation.
A. Suggested Definitions: We believe that the inclusion of a precise, medically-appropriate definition of “abortion” in the proposed regulation is needed. HHS can either (1) specifically use (or reference) an existing definition from federal law or (2) consider using an appropriate definition of “abortion” from another source. However “abortion” is ultimately defined in the proposed regulation, it must be broad enough to cover healthcare providers who espouse the view the human life begins at conception and that a pregnancy begins at fertilization. (See discussion in subsection (B) below).
In light of this recommendation and the controversy surrounding the proposed regulation, we also recommend that HHS consider adding medically-appropriate definitions for the following terms to the proposed regulation: “pregnant” or “pregnancy;” “conception;” and “contraception.”
These additional definitions may be necessary to ensure an appropriate understanding of the definition of “abortion” and to adequately define the scope of protection provided by the proposed regulation.
B. Historical Perspective on Medically-Appropriate Definitions: Simply, the contrived controversy advanced by pro-abortion advocates such as Planned Parenthood is purposefully distracting from the intended purpose of the proposed regulation: protecting the freedom of conscience of all healthcare providers and ensuring that no one is compelled to participate in abortions or any other controversial procedure in violation of his/her conscience. However, given the arguments being made by pro-abortion advocates, it is important to put their claims into an appropriate and historically-accurate perspective.
At their heart, pro-abortion advocates’ claims about the proposed regulation revolve around the appropriate definition of “conception” and the understanding of when pregnancy begins – two concepts that pro-abortion and family planning advocacy groups have worked hard to change within the medical establishment and public perception.
In an effort to make some forms of contraception, abortifacient drugs, and abortion more palatable to the American public, these groups and their allies have actively sought to redefine “pregnancy” as beginning at implantation, and not at fertilization (as the more traditional and majority view holds).
Despite the claims of abortion and family planning advocates, the position that pregnancy begins at implantation and not fertilization is not “long-standing” or the predominant view. For example, the 1913 edition of the Webster’s Revised Unabridged Dictionary defined “conception” as “the act of becoming pregnant; fertilization of an ovum by a spermatozoon.”19 In fact, it was widely and well accepted, based upon reliable scientific knowledge, that conception occurred and pregnancy began at fertilization when the sperm and egg united, or very shortly thereafter, but certainly prior to implantation. It was also accepted that anything which prevented implantation of a fertilized egg caused an abortion. The U.S. Government recognized this understanding and stated in a 1963 public health service leaflet:
“All the measures which impair the viability of the zygote [newly created human] at any time between the instant of fertilization [union of sperm and egg] and the completion of labor constitute, in the strict sense, procedures for inducing abortion."20
Later, in 1965, ACOG, a long-standing supporter of abortion and family planning, issued a medical bulletin that sought to change the accepted definition of “conception” from union of sperm and egg to implantation: "Conception is the implantation of a fertilized ovum [egg].”21 Importantly, this change did not appear to be driven by then-existing (or subsequent) scientific advances in biology, embryology, obstetrics, or gynecology. Notably, ACOG has been joined in its view by abortion and family planning advocacy groups such as Planned Parenthood.
However, despite the concerted efforts of ACOG and those advocating for unrestricted abortion and family planning, the majority of medical resources including prominent medical dictionaries continue to define “conception” (and “pregnancy”) as beginning at fertilization.
Medical dictionaries, in particular, play a prominent role in this debate because they are relatively free of political and other bias. Medical dictionaries such as Stedman’s (28th edition) and Mosby’s (7th edition) define “conception” as occurring at fertilization and not at implantation.22 In pertinent part, these and other important resources provide:
Additional prominent resources that define “conception” as beginning at fertilization (not implantation) include:
Obviously, many important resources and groups define a pregnancy as beginning at conception (that is, the fertilization of the egg by the sperm). However, there exists a minority opinion that pregnancy actual begins at implantation (when the embryo implants in the lining of the uterus). Some dictionaries give both definitions, often with an emphasis on fertilization and a lesser emphasis on implantation. For example, the Merriam-Webster Dictionary’s definition of conception includes both views on when a pregnancy begins.28
Fewer sources advance the sole view that pregnancy begins at implantation. These include medical dictionaries such as Taber’s Cyclopedia Medical Dictionary (20th edition) and the dictionaries of the National Institute of Health and the National Cancer Institute. Furthermore, some medical authorities, like the American Medical Association and the British Medical Association, have defined the term “established pregnancy” (emphasis added) as occurring after implantation.29
More prominently and significantly, national groups advocating for unrestricted and unregulated abortion and family planning uniformly define “conception” and the beginning of a pregnancy as occurring at implantation. They do this without qualification and without noting that this is, in fact, the minority view. For example, Planned Parenthood states:
Medical and scientific experts agree that pregnancy begins with implantation. It happens several days after fertilization when the developing pre-embryo is implanted in the wall of the uterus. Implantation begins the release of hormones that are necessary to support a pregnancy.
In short, a woman is not pregnant until the developing pre-embryo is attached to her and gets nutrients from her. For example, a fertilized egg in a petri dish does not represent a pregnancy.30
The medical authorities briefly highlighted above demonstrate why medical professionals are justified, on biological and medical grounds, in conscientiously objecting to drugs, devices, or other mechanisms that work to end a pregnancy after fertilization. Federal law needs to make clear that conscience protections extend to such objections and that these conscience-based objections will be respected. Clearly, it is the intent of the proposed regulation to make that clarification in federal law and to provide a much-needed enforcement mechanism for existing protective federal laws. This action is long overdue.
Moreover, the differing views as to “conception” and when pregnancy begins are clearly accommodated in the proposed regulation; however, AUL asserts that the inclusion of a precise and well-vetted definition of “abortion,” along with definitions of additional terms such as “conception,” are legally and medically appropriate in this context and should be considered.
In closing, we adamantly affirm the need for the proposed regulation as a necessary enforcement mechanism for existing federal laws supporting and furthering healthcare freedom of conscience.
Sincerely,
Denise M. Burke
Vice President & Legal Director
1 See Federal Register, Vol. 73, No. 155, 50274-85 (hereinafter, “proposed regulation”).
2 Existing federal protections for healthcare freedom of conscience include the Church Amendments, the Hyde-Weldon Amendment, and other federal statutes. A list of these protective laws can be found at www.usccb.org/prolife/issues/abortion/fedlawsconsciencerghts.shtml (last visited September 22, 2008).
3 For more information on healthcare freedom of conscience, see http://www.aul.org/ROC_Primer (last visited September 22, 2008).
4 Voice of America, US Faces Obstetrician Shortage, August 2006, available at: http://www.voanews.com/english/archive/2006-08/2006-08-07-voa51.cfm (last visited September 22, 2008).
5 Myrle Croasdale, Medical Schools on Target to Reach Enrollment Goals, June 23/30, 2008, available at: http://amednews.com (last visited September 22, 2008).
6 Report released by Dr. Peter Buerhaus in March 2003. The Future of the Nursing Workforce in the United States: Data, Trends and Implications. The report estimated demand for RNs growing 2% to 3% each year.
7 HRSA report, What is Behind HRSA’s Projected Supply, Demand, and Shortage of Registered Nurses? Additionally, according to the latest projections from the U.S. Bureau of Labor Statistics published in the November 2007 Monthly Labor Review, more than one million new and replacement nurses will be needed by 2016. Government analysts project that more than 587,000 new nursing positions will be created through 2016 (a 23.5% increase), making nursing the nation’s top profession in terms of projected job growth. Available at: www.bls.gov/opub/mlr/2007/11/art5full.pdf (last visited September 22, 2008).
8 The 2007 State of America’s Hospitals – Taking the Pulse.
9 Bernard Hodes Group July 2006 study, Nursing Management Aging Workforce Survey.
10 March 2008 statement released by an independent health care group study based at the University of Pennsylvania, The Council on Physician and Nurse Supply.
11 In the March-April 2005 issue of Nursing Economic$, Dr. Peter Buerhaus and colleagues found that more than 75% of RNs believe the nursing shortage presents a major problem for the quality of their work life, the quality of patient care, and the amount of time nurses can spend with patients. Almost all surveyed nurses see future shortages as a catalyst for increasing stress on nurses (98%), lowering patient care quality (93%), and causing nurses to leave the profession (93%). According to a study in the October 2002 Journal of the American Medical Association, nurses reported greater job dissatisfaction and emotional exhaustion when they were responsible for more patients than they can safely care for. Researcher Dr. Linda Aiken concluded that "failure to retain nurses contributes to avoidable patient deaths."
12 In March 2007, a comprehensive report initiated by the Agency for Healthcare Research and Quality was released on Nursing Staffing and Quality of Patient Care. Through meta-analysis, the authors found the shortage of registered nurses, in combination with an increased workload, poses a potential threat to the quality of care.
13 Published in the March 2006 issue of Nursing Economic$, a comprehensive analysis of several national surveys on the nursing workforce found a majority of nurses reporting the RN shortage is negatively impacting patient care and undermining the quality of care goals set by the Institute of Medicine and the National Quality Forum.
14 In an article published in the September/October 2005 issue of Nursing Economic$, Dr. Peter Buerhaus and associates found the majority of RNs (79%) and Chief Nursing Officers (68%) believe the nursing shortage is affecting the overall quality of patient care in hospitals and other settings, including long-term care facilities, ambulatory care settings, and student health centers.
15 According to a study published in the October 23/30, 2002 issue of the Journal of the American Medical Association. Conducted by nurse researchers at the University of Pennsylvania and funded by the National Institute for Nursing Research.
16 Id.
17 Id.
18 Forty-seven states provide some protections for healthcare freedom of conscience. Only Alabama, New Hampshire, and Vermont are without protective laws. For more information on state protections, see http://www.aul.org/ROC_Primer (last visited September 22, 2008).
19 Webster’s Revised Unabridged Dictionary (1913), available at: http://dict.die.net/conception/ (last visited on September 22, 2008).
20 Public Health Service Leaflet No. 1066, U.S. Dept of Health, Education, and Welfare, 1963, 27.
21 American College of Gynecology Terminology Bulletin (September 1965).
22 Importantly, these widely-respected medical resources are the same dictionaries technical writers use when writing other medical texts and references.
23 STEDMAN’S MEDICAL DICTIONARY 4 (28th ed. 2006).
24 Seventh Edition, 2006.
25 Second Edition, 2003.
26 Id.
27 See http://www.mercksource.com/pp/us/cns/cns_hl_dorlands_split.jsp?pg=/ppdocs/us/common/dorlands/dorland/seven/000086088.htm (last visited September 22, 2008).
28 See http://medical.merriam-webster.com/medical/conception (last visited September 22, 2008).
29 See e.g., FDA Rejection of Over-The-Counter Status for Emergency Contraception Pills, AMA House of Delegates Resolution 443, (2004), available at: http://www.ama-assn.org/ama1/pub/upload/mm/15/res_hod443_a04.doc (last visited September 22, 2008) (The Plan B pill is a post-coital contraception method which […] induce(s) minor changes to the endometrium to inhibit ovum implantation; therefore, it cannot terminate an established pregnancy…”); British Medical Association, Abortion Time Limits: A Briefing Paper from the BMA 1 (2005), available at: http://www.bma.org.uk/ap.nsf/AttachmentsByTitle/PDFAbortionTimeLimits/$FILE/Abortiontimelimits.pdf (last visited September 22, 2008) (“The term “abortion” is used […] to refer to the induced termination of an established pregnancy [i.e. after implantation].”).
30 See http://www.plannedparenthood.org/health-topics/pregnancy/how-pregnancy-happens-4252.htm (last visited September 22, 2008).