September 25, 2008

The Honorable Michael O. Leavitt

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

**RE: Comments on Health and Human Services \-- "Provider Conscience
Regulations" -- Notice of Proposed Rulemaking, 73 Fed. Reg. 50274,
August 26, 2008, RIN 0991-AB48**

Dear Secretary Leavitt:

The National Family Planning & Reproductive Health Association (NFPRHA)
submits these comments on the proposed rule published at 73 Fed. Reg.
50274 that purports to interpret the Church, Coats, and Weldon
Amendments.

NFPRHA is a membership organization representing many of the nearly
4,500 private, non-profit health centers and state, local and county
health departments, that provide health care services through the Title
X family planning program, and are committed to providing patients the
full range of comprehensive family planning and reproductive health care
services as the program requires. As applied to Title X recipients and
other federally funded health care providers, the proposed regulations
could drastically limit access to basic health care for low-income and
uninsured patients, and could present a substantial step backwards for
the health of women and men in this country.

Given the alarming number of Americans who currently lack health
insurance, the Department of Health and Human Services (HHS) should be
working to increase access to these crucial health care services, rather
than working to limit them. On behalf of our members nationwide, we are
deeply concerned that these unnecessary and overreaching regulations
ignore the needs and rights of patients, create confusion about the
rights and responsibilities of health care providers, threaten important
state protections for access to contraception, and undermine access to
health care for millions of Americans. We therefore strongly urge that
you stop all efforts to promulgate this proposed rule.

***Background***

The proposed rule purports to interpret and educate recipients of
Department funds about three federal statutes that give individuals and
institutions the ability to refuse to participate in certain health
services or research activities in certain circumstances. These statutes
are the Church Amendments (42 USC 300a-7), the Coats Amendment (42 USC
238n), and the Weldon Amendment (Consolidated Appropriations Act 2008,
PL 110-161, Div. G, 508d). The regulations, however, dramatically expand
the scope and reach of these laws.

For decades, federal law has given individuals and institutions certain
rights to refuse to provide abortion and sterilization services. The
Church Amendments were enacted by Congress in the 1970s in response to
debates about whether the receipt of federal funds requires recipients
to provide abortion or sterilization services. These provisions make
clear, among other things, that:

-   The receipt of federal funding under certain laws does not require
    any individual to perform or assist in the performance of
    sterilization or abortion procedures if those procedures are
    contrary to the individual's religious or moral beliefs;

-   The receipt of such funding does not require entities to make their
    facilities or personnel available for sterilization or abortion
    procedures if those procedures are contrary to the religious or
    moral beliefs of the entity or individual; and

-   Health care personnel employed by certain federally funded programs
    and facilities cannot be discriminated against for refusing to
    perform or assist in the performance of sterilization or abortion
    services to which they object based on their religious or moral
    beliefs.

Congress adopted the Coats Amendment in response to a decision by the
accrediting body for graduate medical education to require Ob/Gyn
residency programs to provide or permit abortion training. Adopted in
1996, the Coats Amendment prohibits federal, state, and local
governments from "discriminating" against entities that refuse to
provide or require training in abortions or individuals who refuse to be
trained to provide abortions.

Beginning in 2004, Congress has attached the Weldon Amendment to the
annual appropriations measure that funds the Departments of Labor,
Health and Human Services, and Education. That Amendment prohibits
federal agencies and programs and state and local governments that
receive money under the Act from "discriminating" against individuals,
health care facilities, insurance plans, and other entities because they
refuse to provide, pay for, provide coverage of, or refer for abortion.

***The Department Should Withdraw the Proposed Rule Because it Imposes
New Roadblocks to Women's Access to Contraceptive Services***

We are seriously concerned by statements from you that suggest that the
Department intends for the regulations to provide a new, potentially
unlimited right for institutions and individuals to refuse to provide
contraceptive services. This would be a dramatic and unprecedented
expansion of the existing refusal laws, and could have enormous public
health consequences.

In an earlier draft version of this regulation, HHS made clear that the
purpose of the regulation is to make it easier for government programs,
hospitals, insurance companies, and individuals to refuse to provide
basic reproductive health services -- including information, referrals,
and contraceptive services -- to women. HHS cited several "problems" the
regulations were intended to address, including state laws requiring
employers to provide contraceptive coverage on an equal basis with all
other prescriptions in their insurance plans, requiring emergency rooms
to offer rape survivors medication to prevent pregnancy (emergency
contraception), and requiring pharmacies to provide women with birth
control pills and emergency contraception.

The earlier draft also included a redefinition of abortion, which
extended the reach of the existing refusal laws -- laws that were
intended by Congress to cover only abortion and, in some instances,
sterilization -- to cover some of the most widely used forms of
contraception.

While the proposed regulations published on August 26 do not include
either the explicit redefinition of abortion or discussion of the
previously cited "problems," the leaked draft and the subsequent
comments by you create tremendous confusion about whether the Department
intends to interpret the statutory rights to refuse to participate in
abortion services to now encompass a right to refuse to provide
contraceptives. (When asked to clarify that the regulation does not
apply to birth control, you stated on a conference call to reporters:
"This regulation does not seek to resolve any ambiguity in that area."
You also stated that some groups might seek to "press the definition" of
abortion to include contraception, and already groups opposed to
contraception have announced their intention to do just that (Stephanie
Simon, "Rules Let Health Workers Deny Abortions," Wall Street Journal,
August 22, 2008, Page A3).

Such an interpretation would be contrary to both accepted medical
understandings and federal law. Medical experts, including the American
College of Obstetricians and Gynecologists, the American Medical
Association, and the British Medical Association, have consistently
defined pregnancy as beginning when a fertilized egg is implanted in the
lining of a woman's uterus, establishing a bright line between
contraceptives, which prevent pregnancy, and abortifacients, which
terminate it. Even the most extreme of federal restrictions on funding
for abortion services, the Hyde Amendment, adopts this definition and
the clear distinction it provides between abortion and contraception:
the Hyde Amendment blocks the use of public funding to pay for abortion
services, but specifically allows public funds to be used for "drugs or
devices to prevent implantation of the fertilized ovum."

In addition, acceptance of this definition of abortion by the Department
would undermine public health and the ability of women and families to
make critical decisions about whether to have a child. Contraception
improves the health of women and children by enabling women to plan and
space their births. More than 90 percent of American women will use
contraception at some point in their lives. Access to publicly funded
comprehensive family planning services, including contraception, allows
low-income and uninsured women and men to act responsibly, stay healthy
and plan their families.

Today, more than 17 million women in America are in need of publicly
funded contraceptive services, a number that continues to rise as more
and more people become uninsured and unemployed as our economy
struggles. According to researchers at the Guttmacher Institute, without
the contraceptive services provided at publicly funded clinics, there
would be *46% more unintended pregnancies* (1.4 million more) annually
in the United States. Women with unintended pregnancies are less likely
to obtain timely or adequate prenatal care, and unintended pregnancy
increases the likelihood of low birth-weight babies and infant
mortality.

But if adopted, the proposed rule could severely undermine women's
access to contraceptives. For example, in recent years, states across
the country have passed laws that protect women's ability to access
basic reproductive health care. Yet, if the Department allows health
care entities to use the rule to refuse to provide contraceptives, the
proposed rule could undermine a state's ability to enforce its own laws
protecting contraceptive access. For example, the regulation could
interfere with state laws requiring insurance plans that cover other
prescription drugs to also cover birth control. It could also create an
opening for hospitals to refuse to comply with state laws requiring that
sexual assault survivors be offered emergency contraception. Under the
proposed rule, hospitals could be exempted from even having to tell rape
survivors that such medication exists. The proposed regulations could
also undermine state laws requiring pharmacies to fill prescriptions for
contraception, as well as laws that permit state and local governments
to refuse to allow hospitals to merge when the merger would result in
the elimination of reproductive health services in the community.

In addition, as discussed more fully below, such an unwarranted and
unauthorized expansion of the definition of abortion to include
contraception would threaten the ability of the Title X program to
continue to provide comprehensive, quality family planning services.

The Department should therefore withdraw the proposed rule. At the very
least, the Department should clarify that to the extent the Church,
Coats, and Weldon Amendments provide certain rights to refuse to
participate in abortion services, those rights do not extend to the
provision of contraceptive services.

***The Proposed Rule is Likely to Interfere With the Ability of the
Title X Program to Continue to Provide Comprehensive, High Quality
Family Planning Services to the American People***

The proposed rule also threatens to impair the ability of Title X
grantees and providers to ensure access to the comprehensive, high
quality family planning services that the American people deserve and
that Congress intends the program to provide.

-   *The Proposed Rule Fails to Mention Patient Needs or the Careful
    Balance Struck by Existing Federal Civil Rights Law*

The proposed rule allows individuals to refuse to provide health care
services to which they object on religious or moral grounds, without any
mention of the needs of the patient. In doing so, the proposed rule
fails to address serious questions as to whether its purpose is to upset
the careful balance struck in current federal law between respecting
employee's religious beliefs and employers' ability to provide their
patients with health care services.

Title VII of the Civil Rights Act of 1964 provides a balance between
employers' need to accommodate their employees' religious beliefs and
practices -- including their refusal to participate in specific health
care services to which they have religious objections -- with the needs
of the people the employer must serve. Under Title VII, employers have a
duty to reasonably accommodate an employee or applicant's religious
beliefs, unless doing so places an "undue hardship" on the employer.
This law provides protection for individual belief while still
protecting patient access to health care services. An extensive guidance
released in July 2008 by the Equal Employment Opportunity Commission
(EEOC), discusses in great detail the scope of employers' obligations to
accommodate the religious beliefs of their employees and employers'
ability to take into account the needs of their patients (EEOC
Compliance Manual, Section 12, "Religious Discrimination," updated July
22, 2008 (available at http://www.eeoc.gov/policy/docs/religion.pdf)).

Strikingly, the proposed rule makes no mention of either Title VII or
the EEOC's guidance. It provides no guidance about how, if at all,
health care employers are permitted to consider patients' needs when
faced with an employee's refusal to provide services.

For example, the rule provides no guidance about whether it is
impermissible "discrimination" for a Title X family planning clinic that
serves primarily women seeking contraceptive services not to hire a
receptionist because she refuses to make contraceptive appointments or a
nurse because he refuses to provide contraceptive services?

Is it "discrimination" for a Title X clinic not to hire a counselor
whose essential job functions would include counseling women with
positive pregnancy tests because the counselor refuses to provide
non-directive options counseling?

Is it "discrimination" for a federally funded health department to
transfer such a counselor out of the health department's family planning
project to a unit where pregnancy counseling is not done?

The failure to mention Title VII and the lack of any such guidance
creates serious uncertainty about whether the Department intends to
upset the careful balance struck by Title VII between accommodating
employees' religious refusals and the employer's ability to take into
account their patients' need to access health services. The proposed
rule thereby imposes an unacceptable burden on both health care
providers and the patients they serve.

-   *The Proposed Rule Threatens to Undermine the Title X Program By
    Increasing the Ability of Entities Who Refuse to Provide Family
    Planning Services to Get Title X Funding*

The proposed rule also threatens to divert scarce family planning
resources away from entities that provide comprehensive family planning
services to organizations that refuse to provide basic reproductive
health care services such as non-directive options counseling and
contraceptive services. Depending on how the Department interprets the
word "discriminate" entities that refuse to provide women with complete
information and that refuse to provide contraceptive services may be
able to compete on the same footing for federal money with family
planning providers who responsibly provide full and accurate information
and services to patients. Despite the incredible success of the Title X
program and the critical services it provides, Title X has been
chronically underfunded. Recent dramatic increases in the cost of
hormonal contraceptives, along with new and expensive contraceptive
technologies and STD screening and treatment, HIV testing, the expense
of training and retaining qualified health care personnel in an era of
nursing shortages, and a growing number of patients in need of these
critical health services have only stretched already-tight budgets even
further.

Diverting funds away from providers offering comprehensive reproductive
health care would not only seriously undermine public health, especially
for the low-income and uninsured, but would also be contrary to
Congressional intent and explicit statutory requirements. Section 1001
of the Public Health Service Act (42 USC 300), the statute governing
Title X, authorizes grant making for "family planning projects which
shall offer a broad range of acceptable and effective family planning
methods and services." Projects are designed to "consist of the
educational, comprehensive medical, and social services necessary to aid
individuals to determine freely the number and spacing of their
children" (42 CFR 59). To meet these program goals, projects are
required to provide "medical services related to family planning
(including physician's consultation, examination prescription, and
continuing supervision, laboratory examination, contraceptive supplies)
and necessary referral to other medical facilities when medically
indicated, and provide for the effective usage of contraceptive devices
and practices." (42 CFR 59.5)

Moreover, Congress specifically requires that "all pregnancy counseling
shall be non-directive" (Public Law 110-161, p. 327) and has repeatedly
reaffirmed this commitment to providing women with their full range of
pregnancy-related options by including this language in every Labor,
Health and Human Services and Education Appropriations Act since Fiscal
Year 1997. Current regulations require that pregnant women, upon
request, receive "neutral, factual information and nondirective
counseling, and referral upon request" about prenatal care and delivery,
adoption, and pregnancy termination (42 CFR 59.5(a)(5)). To the extent
that the proposed rule enhances the ability of entities that refuse to
provide the services that Congress intended the program to cover to
compete for federal funding, it conflicts with the appropriations law
and Congressional intent and must be withdrawn.

***The Proposed Rule Threatens Patient Autonomy and Well-Being by
Authorizing Health Care Providers To Withhold Information From
Patients***

The proposed rule permits employees of Title X and other federally
funded entities to refuse to provide information, counseling, and
referrals to patients, without any mention of patient needs or whether
an employer can accommodate such a refusal without undue hardship. In so
doing, the proposed rule invites health care professionals to violate
their legal and ethical duties of providing complete, accurate, and
unbiased information necessary to obtain informed consent. The failure
of health care professionals to provide such information threatens
patients' autonomy and their ability to make informed health care
decisions, decisions that may be life-altering.

***The Proposed Rule Threatens to Undermine Health Services and Research
Activities Well Beyond Reproductive Health***

The regulation also opens the door to undermining access to a broad
spectrum of health care services and the ability of federally funded
institutions and individuals to conduct research. The proposed rule
prohibits any entity that receives HHS funding to carry out any part of
any health service program or to conduct research from requiring any
individual to participate in *any* activity with a reasonable connection
to *any* HHS-funded health service or research activity to which the
individual objects on religious or moral grounds. The rule also
prohibits entities that receive biomedical and behavioral research
funding through HHS from "discriminating" against any individual because
the individual refuses to perform or assist in *any* health service *or*
research activity that he or she objects to on religious or moral
grounds. The breadth of the rule has implications for those providing or
doing research in a wide range of areas including, HIV, drug addiction,
infertility, vaccinations, psychology, sexually transmitted infections
and end-of-life care, among others.

Although the statutes that these provisions purport to interpret have
been on the books for over 30 years, the proposed rule radically expands
their reach and fails to place any explicit limits on their application.
For example, the proposed rule dramatically reduces the degree of
connection to the objected-to service one must have in order to obtain
an exception. The statutes Congress enacted permit refusals only by
those who refuse "to perform or assist in the performance of" a health
service or research activity. The proposed rule, however, permits
refusals by anyone with a reasonable connection to the service or
research activity, which the Department says should be broadly
interpreted. This dramatically increases the number of individuals who
will now be able to refuse. This problem is exacerbated because again
the proposed rule fails to mention, how, if at all, the needs of
patients or the needs of research institutions to conduct vital research
are to be factored into the equation. For example, what leeway, if any,
does a federally funded HIV researcher have not to hire a secretary who
refuses based on his moral beliefs to do work that supports such
research? What leeway, if any, does such a researcher have to arrange a
transfer for such a secretary to another department at the university?

***The Regulations Jeopardize Access to Emergency Health Services***

Further ignoring the needs and rights of patients, the proposed rule
fails to provide guidance detailing what obligations individuals and
entities have in the case of medical emergencies. For example, under the
Emergency Medical Treatment and Active Labor Act (EMTALA), hospitals are
required to at least stabilize a patient who comes into an emergency
room in a medical emergency. The proposed regulation is at best unclear
about whether a provider's ability to refuse to perform a procedure
would be allowed to trump a patient's need to be treated in a medical
emergency, including life-threatening emergencies.

\* \* \*

For the reasons discussed above, we urge HHS to withdraw the proposed
rule. Should HHS insist upon proceeding with the proposed rule, the
agency should substantially modify its proposal in accordance with the
forgoing comments.

Sincerely,

![](media/image3.jpeg){width="2.2715277777777776in"
height="0.5576388888888889in"}

Mary Jane Gallagher

President & CEO

National Family Planning & Reproductive Health Association