September 25, 2008
Department of Health and Human Services
Office of Public Health and Science
Attn: Brenda Destro
Hubert Humphrey BuildingRoom 728E
200 Independence Avenue SW
Washington, D.C.
RE: RIN 0991-AB48 ?Ensuring that Department of Health and Human Services Funds
Do Not Support Coercive or Discriminatory Policies or Practicesin Violation of Federal Law?
On behalf ofthe National Health Law Program and the undersigned organizations and health
professionals, we are submitting these commentsto the federal Department of Health and Human
Servicesin opposition to the proposed regulation entitled ?Ensuring that Department of Health
and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practicesin
Violation of Federal Law.?
The regulations as proposed would introduce broad, poorly defined, and confusing language to
the existing law that protectsthe right of health care providersto refuse to participate in a health
care service to which they have moral orreligious objections. There are already ample statutory
protectionsfor health care providers who object to providing certain services based on their
religious or moral beliefs. Existing law seeksto establish a delicate balance between protecting
health care providers and meeting the needs of patients. The proposed regulations cite no
evidence that further explication is needed other than the ?concern? ofthe Department. Yet,
HHS is offering a complex set ofregulationsto implement three differentstatutes1that were
enacted over the span of more than thirty years, muddying the waters ofrefusal clauses, and if
implemented,severely impacting health outcomes.
Most important, the regulationsfail to account forthe significant burden on patients, a burden
that willfall disproportionately and most harshly on low-income women, that will be imposed by
implementation ofthe proposed regulations.
While the proposed regulations purport to provide clarity and guidance in implementing existing
federal conscience clausesthat protect individuals and institutions, in reality they are vague and
confusing, and create the potentialfor exposing patientsto medical care thatfailsto comply with
established medical practice guidelines, negating long-standing principles ofinformed consent,
and undermining the ability of health facilitiesto provide required information, counseling,
referrals, and health care servicesin an orderly and efficient manner. The end result could be
poorer health outcomes and higher costsfor delivering quality care.
The regulationsfailto define importantterms and may cause greater confusion not clarity
Pertinent termssuch as ?discrimination? and ?abortion? are not defined in the regulations,
leaving important questions open to individual interpretation, and potentially creating chaosfor
patients and health systems.
The regulations are unclear asto whether ?abortion? includes birth control, in particular
emergency contraception. While a California court in Brownfield v. Daniel Freeman Marina
Hospital2 found that EC is not an abortifacient, Secretary Michael Leavittsuggested that the term
remained ambiguousin the regulationsso that individuals or institutions were able to define it
for themselves. When asked about whether the regulations? definition of abortion included birth
control, as had an earlier draft, Secretary Leavittsaid, ?Thisregulation does notseek to resolve
any ambiguity in that area. It focuses on abortion and focuses on physicians' conscience in
relation to that.?3 Failing to define the term abortion raisesimportant questions about which
health services an entity can refuse to provide. Can an insurerrefuse to cover contraception in
violation of a state?s contraceptive equity statute? Can a state refuse to certify a hospital as a
Sexual Assault Center if itrefusesto provide emergency contraception asrequired by state law?
Other questionsremain about how the regulationsintersect with otherfederal laws. The
regulationsinterfere with the delivery of emergency services. Isthe removal of a life-threatening
ectopic pregnancy an abortion for which a health worker can refuse to admit the patient? How
will the regulationsintersect with EMTALA requirementsin emergency miscarriages?
The failure to define the term ?discrimination? is equally distressing. Title VII already requires
that employers accommodate employees? religious beliefsto the extent there is no undue
hardship on the employer. The regulations make no reference to Title VII and leave the question
of what constitutes ?discrimination? unexplained. Can a health entity require that a worker
notify it in advance about objections? Can the entity reassign someone who refusesto assist in
certain services? By failing to define ?discrimination,? the regulations could leave employers
vulnerable to liability, and supervisors unable to proceed in the orderly delivery of health care
services, and women?s health atrisk.
The regulations are overly broad, confusing, and have the potentialto create instability in
health care delivery
The regulations dangerously expand the application of the underlying statutes by offering an
extremely broad definition who can refuse and what they can refuse to do. The regulations
suggest that virtually any worker, paid or volunteer, in a health care, wellness, or research setting
can refuse to ?assist in the performance? of a health care services or in a health care program.
By describing a worker who washesthe instruments after a procedure as an example of what it
meansto ?assist in the performance,? the regulationsfail to offer any useful guidance to
employers. If workersin very tangential positions(such as admitting, billing, or custodial) are
able to refuse to do their jobs based on personal beliefs, they will undermine the ability of any
health system or entity to plan, to properly staff, and to deliver quality care. Employers and
medicalstaff may be stymied in their ability to establish protocols, policies and procedures under
these vague and broad definitions. In addition,stretching the interpretation and definition of a
?health care service? itself as ?participation in any activity with a reasonable connection to the
objectionable procedure including referrals, training, and other arrangementsfor offending
procedures? and ?an activity related in any way to providing medicine, health care, or any other
service related to health or wellness? createsthe potential for a wide range of workersto interfere
with and interrupt the delivery of health care in accordance with the standard of care.
The regulations also leave unclear whether a worker can assert his or her moral beliefin refusing
to treat a particular patient. Can a technician refuse to participate in dialysisfor an alcoholic?
Can someone opposed to blood transfusionsrefuse to change a patient?s hospital gown? Can a
health providerrefuse to treat a patient who is gay or lesbian? Orrefuse to provide prenatal care
to a woman the workerthinks already hastoo many children?
The regulations as written are subject to misuse and abuse by creating a health care environment
that inviteslarge numbers of workers and health professionalsto refuse to participate in the
orderly delivery of health care services.
The regulationsfailto addressthe significant health impact of broadly construed refusals
The regulations assert boldly that, ?Thisregulation does not limit patient accessto health care,?
yet offer no substantiation ofthat claim. Data in this area islimited, however, the Department
hasthe responsibility to provide evidence thatsuch broad-based refusals do not undermine
patient care.
When patients are faced with refusals, their health suffers. Medical practice guidelines and
standards of care establish the boundaries of medical care that patients can expect to receive and
that providersshould be expected to deliver. Information, counseling, referral and provisions of
contraceptive and abortion services are part of the standard of care for a range of common
medical conditionsincluding heart disease, diabetes, epilepsy, lupus, obesity, and cancer. Many
medications can cause significant fetal impairments, and therefore the Federal Food and Drug
Administration and professional medical associationsrecommend that women use contraceptives
to ensure that they do not become pregnant while taking these medications.4 For example, the
FDA?s own iPledge program that governsthe use of the drug Accutane® forsevere acne
treatment clearly statesthat women should use two forms of contraception and that ?natural
family planning? is not an accepted method.
The importance of the ability of women to make decisionsfor themselvesto prevent or postpone
pregnancy is well-established within the medical guidelines across a range of practice areas. In
2002, 35 percent of all pregnancies were unintended ? meaning that they were either unwanted
or mistimed.6 Unintended pregnancy is often a consequence of poverty. Low-income women
have higher rates of unintended pregnancy asthey are least likely to have the resourcesto obtain
reliable methods offamily planning, and yet, they are most likely to be impacted negatively by
unintended pregnancy.7 The Institute of Medicine associates unintended pregnancy with an
increased risk of morbidity for women, insufficient prenatal care, low birthweight babies, an
increase in health behaviors during pregnancy that are associated with adverse effects, as well as
a negative impact on parenting by both mothers and fathers.8
The health servicesimpacted by refusals are most often related to reproductive and sexual health,
however, they are also implicated in a wide range of common health treatment and prevention
strategies. For example, black women have higher prevalence of heartfailure, coronary heart
disease, hypertension, and stroke than white women.9 According to the Centersfor Disease
Control and the American College ofCardiology, all of these conditions can be exacerbated by
pregnancy, resulting in poorer health outcomesfor women and their children. Medical practice
guidelines and the CDC?s Guidelinesfor Preconception Care recommend that women atrisk for
pregnancy use contraceptives while bringing their condition under control before they become
pregnant.10
The health impact ofrefusal clauses wasrecently illustrated in the American Journal of Public
Health. The authorsstudied miscarriage management in Catholic hospitals acrossthe country
and reported five situationsin which pregnant women were put atseriousrisk when the hospitals
refused to allow their physiciansto treat them in accordance with the medicalstandard of care.11
Broadly-defined and widely-implemented refusal clauses undermine accessto basic health
servicesfor all, but particularly harm low income women. The burdens on low-income women
can be insurmountable when women and families are uninsured, locked into managed care plans
that do not meet their needs, or when they cannot afford to pay out of pocket forservices or
travel to anotherlocation. Last, in rural areasthere may simply be no othersources of health and
life preserving medical care.
In 2006, 28% of non-elderly low-income women were uninsured.12 39% of all non-elderly
Latinas were uninsured, as were 33% of American Indian/Alaskan Native women.13 These
women have limited health care options. They rely on free and low-cost clinics, charity care, or
pay for care out of pocket. When they encounter health care refusals, they have nowhere else to
go.
These issues are not theoretical or philosophical for the real patients whose health issignificantly
impacted by refusalsto provide information, referrals and care.
The regulations undermine long-standing ethical and legal principles of informed consent
Informed consent is at the core ofthe individual?sright to self-determination and to make his or
her own decisions about medically appropriate health care. Thisright is conditional upon two
factors: accessto relevant and medically accurate information about treatment choices and
alternatives; and provider guidance in helping patients make decisions about treatment options
based on generally accepted standards of practice. Both factors make trust between patients and
health care professionals a critical component of quality of care. According to the American
Medical Association, ?The patient?sright ofself-decision can be effectively exercised only ifthe
patient possesses enough information to enable an intelligent choice.?14
Informed consent isintended to help balance the imbalance of power in the relationship between
health providers and patients, wherein patients authorize specific interventions. Disclosure of
medical information is an essential component ofthe provider-patientrelationship, and is
embedded in medical and research codes. How will the regulationsintersect with federal and
state laws on informed consent?
Informed consent is a core ethical as well aslegal tenet for physicians according to the American
Medical Association: ?The physician?s obligation isto present the medicalfacts accurately to
the patient orto the individualresponsible forthe patient?s care and to make recommendations
for management in accordance with good medical practice. The physician has an ethical
obligation to help the patient make choicesfrom among the therapeutic alternatives consistent
with good medical practice.?15
The American Nursing Association similarly requiresthat patient autonomy and selfdetermination are core ethical tenets of nursing. ?Patients have the moral and legalright to determine what will be done with their own persons; to be given accurate, complete and
understandable information in a mannerthatfacilitates an informed judgment; to be assisted with
weighing the benefits, burdens and available optionsin theirtreatment.?16
The American Bar Association (ABA) has adopted policy in opposition to refusal clausesthat
restrict information that patients need to make sound medical decisions,stating ?the ABA
opposes governmental actions and policiesthat interfere with patients? abilitiesto receive from
their health care providers, including health care professionals and entities, in a timely manner:
(a) all of the relevant and medically accurate information necessary for fully informed health
care decision-making; and (b) information with respect to their accessto medically accurate care,
as defined by the applicable medicalstandard of care.?17
Conclusion
Asthe country faces numerous challengesin meeting the health care and public health needs of
itsresidents, these regulations will make the delivery ofthese services more difficult, more
costly, and less efficient. We urge you to withdraw these regulationsin consideration of the
extreme hardship they will cause for patients and providers. If you will not withdraw the
regulations, we request that you modify them as noted above.
Thank you for your consideration.
Sincerely,
National Health Law Program
On behalf of:
Organizations:
California Black Women?s Health Project
Maternal and Child Health Access
National Center for Youth Law
National Immigration Law Center
Western Center on Law and Poverty
Health professionals: Affiliations noted foridentification purposes only
Gary A. Richwald, MD MPH
Los Angeles, California
Eleanor Bimla Schwarz, MD, MS
Assistant Professor of Medicine, Epidemiology,
Obstetrics, Gynecology, and Reproductive Sciences
University of Pittsburgh
Center for Research on Health Care
Carol S. Weisman, PhD
Distinguished Professor of Public Health Sciences,
Obstetrics & Gynecology, Health Policy & Administration
Chief, Division of Health Services Research
Principal Investigator, Penn State BIRCWH Program
Penn State College of Medicine
Tracy Weitz, PhD, MPA
Director, Advancing New StandardsinReproductive Health (ANSIRH)
Bixby Center forReproductive Health Research & Policy
Associate Director for Public Policy
UCSF National Center of Excellence in Women's Health
University of California, San Francisco
1
Church Amendment 42 U.S.C. § 300a etseq; Public Health Service Act 42 U.S.C. § 238n; Weldon
Amendment Consolidated Appropriations Act, 2008, P.L. No. 110-161, Div. G § 508(d), 121 Stat. 1844,
2209 (Dec. 26, 2007).
2
Brownfield v. Daniel Freeman Marina Hospital, 256 Cal. Rptr. 240 (1989).
3
ROB STEIN, Protections Set for Antiabortion Health Workers, Washington Post August 22, 2008.
4
ELEANOR BIMLA SCHWARZ MDMS, et al., Documentation of Contraception and Pregnancy When
Prescribing Potentially Teratogenic Medicationsfor Reproductive-Age Women, 147 Annals of Internal
Medicine.(Sept. 18, 2007).
5
U.S. Food & Drug Admin., Accutane® (isotretinoin) Questions and Answers(Oct. 28, 2005)
6
LAWRENCEB. FINER & ELIZABETH K. HENSHAW, Disparitiesin Rates of Unintended Pregnancy in the
United States, 1994 and 2001, 38 Perspectives on Sexual and Reproductive Health.; U.S. DEPARTMENT
OFHEALTH AND HUMAN SERVICES, CENTERS FOR DISEASECONTROL AND PREVENTION Fertility, Family
Planning, and Reproductive Health of U.S. Women: Data From the 2002 National Survey of Family
Growth Series 23, Number 25, DHHS Publication No. (PHS) 2006-1977 (December 2005).
7
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Healthy People 2010; Chapter 9-6.
8
CENTERS FOR DISEASECONTROL AND PREVENTION, Unintended Pregnancy (Apr. 4, 2004);
http://www.cdc.gov/reproductivehealth/UnintendedPregnancy/index.htm.
9
HOLLY MEAD, et al., Racial and Ethnic Disparitiesin U.S. Health Care: A Chart Book, The
Commonwealth Fund, (2008).
10
CENTERS FOR DISEASECONTROL AND PREVENTION, Recommendationsto Improve Preconception
Health and Health Care, 55(RR06);1-23 MMWR.
11
LORI FREEDMAN, et al., When There's a Heartbeat: Miscarriage Management in Catholic-Owned
Hospitals, American Journal of Public Health (Aug. 13, 2008).
2
KAISER FAMILY FOUNDATION, Health Insurance Coverage of Women Ages 18 to 64, by Race/Ethnicity,
2006, (2008).
13
KAISER FAMILY FOUNDATION, Medicaid's Role for Women, (2007).
14
American Medical Association, Medical Ethics E-8.08 Informed Consent (Issued March 1981,
updated October 4, 2005).
15
American Medical Association, Medical Ethics E-8.08 Informed Consent (Issued March 1981;
updated Oct. 4, 2005).
16
American Nurses Association, Code of Ethicsfor Nurses, Provision 1.4,
http://nursingworld.org/ethics/code/protected_nwcoe813.htm.
17
AMERICAN BAR ASSOCIATION, Policy # 05M104 (2005).
