September 22, 2008

Office of Public Health and Science

Department of Health and Human Services

Attention: Brenda Destro

Hubert H. Humphrey Building

200 Independence Avenue, SW Room 728E

Washington, DC, 20201

**RE: Notice of Proposed Rulemaking -- Proposed "Provider Conscience
Regulations" 73 Fed. Reg. 50274, *et.seq.* (August 26, 2008)**

The Washington Association of Community and Migrant Health Centers
(WACMHC) submits these comments on the proposed rule published at 73
Fed. Reg. 50274 that purports to interpret the Church, Coats, and Weldon
Amendments.

The Washington Association of Community and Migrant Health Centers
(WACMHC) is a non-profit organization, formed in 1985, to advocate on
behalf of the low-income, uninsured, and underserved populations of
Washington State served by community health centers.  The Association is
owned by its regular membership consisting of state and federally funded
community health centers, migrant health centers, and Urban Indian
Health Programs all of which serve low income and other persons with
limited access to health care. As a critical safety net for Washington's
most vulnerable populations, we have particular concerns about the
intent of the proposed rule and the potential to further limit access to
basic health care for low-income and uninsured patients.

Health centers are required to provide a vast array of primary and
preventive care services furnished by a multi-disciplinary team of
physicians and mid-level providers as well as a full complement of
non-clinical services to support patient access. When taken together,
virtually any service (clinical and non-clinical support services)
provided by any health center staff (paid and non-paid) may be impacted
by the proposal. For the following reasons, we strongly believe that the
proposed rule would be particularly harmful for Washington's community
health centers.

We cannot support a rule that is contrary to and conflicts with health
centers' service obligations required under Section 330 of the Public
Health Service Act (42 I.S.C. § 254b).The proposed rule would
significantly impede, and in some instances, effectively bar health
centers from furnishing required services to their underserved
populations by prohibiting the centers from the following:

> "\[R\]equir\[ing\] any individual to perform or assist in the
> performance of any part of a health service program or research
> activity funded by the Department if such service or activity would be
> contrary to his religious beliefs or moral convictions." \[73 Fed.
> Reg. 50283; Section 88.4(b)(2)\]

We find this to be problematic for a number of reasons. First, the
proposed rule permits federally funded health care entities and
individuals to refuse to perform or to assist in the performance of a
health service program, meaning "counseling, referral, training, and
other arrangements for the procedure, health service, or research
activity" \[73 Fed. Reg. 50283; Section 88.2\]. In so doing, the
proposal invites health care providers and other health professionals to
violate their legal and ethical duties of providing complete, accurate,
and unbiased information necessary for patients to obtain informed
consent.

The proposal also states that the provisions are "to be interpreted and
implemented broadly to effectuate their protective purposes" \[73 Fed.
Reg. 50282; Section 88.1\] Thus, the proposed rule prohibits any entity
that receives HHS funding from requiring any individual to participate
in any activity to which the individual objects on religious, moral, or
other grounds. The breadth of the rule has implications for those
providing care in a wide range or areas including employees within the
community health center system. Although the Church, Coats, and Weldon
Amendments have existed for a number of years, the proposed rule
significantly increases the scope and reach of these statutes and has a
much broader impact on the total patient population.

Equally disconcerting is the use of the term "other reasons," as stated
in Section 88.1, which gives health care providers and administrative
staff the provision to "refuse to perform health care services to which
they may object for religious, moral, ethical, or **other reasons**."
\[73 Fed. Reg. 50283; Section 88.1; emphasis added\]. This allows health
care employees to refuse to provide or assist in the provision of vital
health services for not only religious or moral causes but also for
"other reasons" without giving the employer any tool for ensuring that
the patient receives adequate and timely health care. Interpreting this
broadly, as the Department encourages, would permit health care entities
and individuals to refuse to participate in a health care service or
activity for any number of reasons reaching far beyond those the
original statutes were intended to provide. Given the potentially broad
scope of these terms, the Department opens the door for individuals to
claim these "other reasons" as grounds for refusal to perform or assist
with a service that the individual simply does not want to provide.

We are furthermore concerned that the proposed rule provides no guidance
detailing what obligations health care entities and individuals have in
the case of medical emergencies. The proposed regulation is, at best,
unclear about whether a provider's ability to refuse to perform a
necessary procedure would take priority over a patient's need to be
treated in a medical emergency, including those that are
life-threatening. The proposal lacks necessary clarity and further
ignores the needs and rights of patients.

This proposed rule appears to stand in open conflict with at least two
federal programs that require contraceptive services to be provided to
clients upon request: Medicaid and Title X.  The Medicaid program
includes birth control as a mandated benefit for patients.  The sole
purpose of the Title X program is to provide family planning and other
related reproductive-health services. This regulation could throw both
programs into chaos by permitting both individual program staff and
health care institutions to refuse provision of family planning
services. In addition, the proposed rule could interfere with state laws
requiring insurance plans to cover other prescription drugs to also
cover birth control[^1]. Similarly, it could create an opening for
hospitals to refuse to comply with state laws requiring that sexual
assault survivors be offered emergency contraception[^2]. 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. We, therefore,
oppose the effort to limit such an essential portion of health care for
Washington's underserved communities.

Given the breadth of the prohibitions cited above and the vagueness of
certain terms, WACMHC believes that the proposed rule would unduly
restrict health centers' ability to comply with their Section 330
service requirements. Insofar as compliance with the proposed rule may
prohibit health centers from complying with their Section 330 service
requirements, it jeopardizes health centers' continued receipt of
federal grant funds to support the provision of health care to
medically-underserved populations, thus further impacting access and
availability of services.

Federally-supported community health centers provide consistently
efficient and comprehensive health care to underserved populations in
Washington State. If finalized, the proposed rule has unchecked
potential to critically limit, if not diminish, the quality and access
of care that community health centers will be able to provide. In light
of these concerns, we urge the Department to withdraw the proposed rule.
Should the department insist in advancing the regulation, it should be
modified considerably to reflect the foregoing concerns.

Sincerely,

Mary Looker

Chief Executive Officer

[^1]: 27 states (AZ, AR, CA, CT, DE, GA, HI, IL, IA, ME, MD, MA, MI, MO,
    MT, NV, NH, NJ, NM, NY, NC, OR, RI, VT, WA, WV and WI) have laws
    and/or policies requiring insurers that cover prescription drugs in
    general to provide coverage of the full range of FDA-approved
    contraceptive drugs and devices. 7 states require some insurance
    plans to coverage contraception (CO, KY, MN, ND, OH, OK and WY).

[^2]: 17 states (AR, CA, CO, CT, IL, MA, MN, NJ, NM, NY, OH (policy does
    not include an enforcement mechanism), OR, PA, SC, TX, WA, and WI)
    require hospital emergency rooms to provide emergency
    contraception--related services to sexual assault victims.