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September 25, 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, D.C. 20201

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

To Whom It May Concern:

The National Association of Community Health Centers (NACHC) is pleased
to respond to the above-cited solicitation from the Department of Health
and Human Services (HHS). NACHC is the national membership organization
for federally-supported and federally recognized health centers
(hereinafter interchangeably referred to as "health centers" or FQHCs)
throughout the country, and is an Internal Revenue Code Section
501(c)(3) organization. NACHC also serves as a source of information,
analysis, research, education, training, and advocacy regarding
medically underserved people and communities.

**BACKGROUND**

There are, at present, approximately 1,200 health center entities
nationwide, which serve as the health care homes to more than eighteen
(18) million persons at more than 7,000 sites located in all fifty (50)
states, Puerto Rico, the District of Columbia, the U.S. Virgin Islands
and the Pacific Islands. Most of these health centers receive federal
grants under Section 330 of the Public Health Service Act (42 U.S.C.
§254b) from the Bureau of Primary Health Care (BPHC), within the Health
Resources and Services Administration (HRSA). Under this authority,
health centers fall into four general categories: (1) those centers
serving medically underserved areas and/or populations (invariably poor
communities), (2) those serving homeless populations within a particular
community or geographic area, (3) those serving migrant or seasonal farm
worker populations within similar community or geographic areas, and (4)
those serving residents of public housing. Although there are some
slight differences in the grant requirements for each of these four
program types, for all intents and purposes, the ways in which these
health centers operate are identical.

BPHC's grants are intended to provide funds to assist health centers
with the costs of providing comprehensive preventive and primary care
(including medical, dental, behavioral health, and pharmaceutical) and
enabling services to uninsured and underinsured low-income patients, as
well as to maintain the health center's infrastructure. Patients from
eligible communities who are not low-income or who have insurance
(whether public or private) are expected to pay for the services
rendered. Approximately 35.4% of the patients served by health centers
are Medicaid/SCHIP recipients, approximately 7.6% are Medicare
beneficiaries, and approximately 38.9% are uninsured.[^1]

FQHCs are required to make services available to all residents of their
service area. *See* 42 U.S.C. §§ 254b(a)(1).[^2] In providing a
comprehensive continuum of care, FQHCs are required to furnish a wide
array of required primary health services, including, among other
things, basic primary care services (family medicine, internal medicine,
pediatrics, obstetrics and gynecology) and preventive health services,
which include (among other services) immunizations and voluntary family
planning services. *See* 42 U.S.C. §§ 254b(b)(1)(A)(i)(I) & (III). FQHCs
also are required to provide various support services to ensure patient
access to services (including those not provided directly by the health
center), such as referrals, case management, enabling services, and
patient education / health promotion. *See* 42 USC §§ 254b(b)(1)(A)(ii)
-- (v).

While there are no specific requirements regarding "appropriate"
staffing mix, FQHCs are expected to maintain a core staff of providers
necessary to provide all required services, including physicians and,
where appropriate, physician assistants, nurse practitioners, and nurse
midwives, as well as appropriate non-clinical staff. *See* 42 U.S.C. §
254b(a)(1); 42 U.S.C. §254b(b)(1)(A)(i)(I). Notwithstanding, FQHCs must
be located in or serve a federally-designated Medically Underserved Area
(MUA) or Medically Underserved Population (MUP). Additionally, a
substantial number of health centers are located in or serve an area,
population or facility that has been designated as a Health Professional
Shortage Area (HPSA). Thus, for the vast majority of health centers,
recruiting and retaining qualified staff is often challenging, at best.

**COMMENTS ON THE PROPOSED RULE**

NACHC believes that the Proposed Rule is very problematic, insofar as it
attempts to place an individual's beliefs in front of access to good
quality comprehensive health care, rather than striking a balance
between the two. We understand the importance of recognizing the
legitimate concerns of health care professionals (and other personnel)
faced with providing or assisting with services which they find
religiously or morally objectionable, and we support efforts to ensure
that such objections are considered and conscience rights are protected.
However, NACHC believes that these considerations should not outweigh
the rights of patients to receive necessary care -- the providers'
rights should not be exercised to the detriment of the patients' health.
Rather, a balance must be struck between the two -- a balance not
evidenced by the Proposed Rule.

In the preamble to the Proposed Rule, HHS states that it is

> Concerned that ... an environment ... that is intolerant of individual
> conscience, certain religious beliefs, ethnic and cultural traditions,
> and moral convictions may discourage individuals from diverse
> backgrounds from entering health care professions ... A trend that
> isolates and excludes some \[providers\] among various religious,
> cultural and/or ethnic groups from participating in the delivery of
> health care is especially troublesome considering current and
> anticipated shortages of health care professionals ... \[73 *Fed.
> Reg.* 50276\]

HHS further contends that the Proposed Rule does not limit patient
access to health care; rather, it protects providers from being
"compelled to participate in, or from being punished for refusal to
participate in, a service that, for example, violates their conscience."
\[73 *Fed. Reg.* 50277\]. HHS attempts to equate federal
nondiscrimination laws, which protect access to care for patients, many
of whom are vulnerable and without health care options, with federal
provider conscience protections, arguing that provider conscience rules
are necessary to protect health care professionals from discrimination
which could impede their ability to practice.

HHS, however, is misguided in its thinking. Presently, medical
professionals are protected from being forced to provide certain
services they deem religiously or morally objectionable. As noted in the
Proposed Rule, current conscience laws allow health care professionals
(employees, volunteers, trainees, others under the authority of the
entity) to refuse to provide abortion and sterilization services and
prohibit requiring an individual to perform or participate in such
services. Further, Title VII of the Civil Rights Act of 1964 (29 U.S.C.
§ 2000e) prohibits discrimination by employers based on an employee's
religious beliefs and practices, providing a balance between protecting
the employee's right to, among other things, refuse to participate in
activities that are contrary to his/her religious beliefs and protecting
the rights of the clients served by the employer to receive
services.[^3]

Unlike the Proposed Rule, current protections generally are balanced
with patient needs, treating both equally as long as that does not place
undue hardship on the patient or the employer. For example, Title VII
requires employers to reasonably accommodate employees' religious
beliefs provided that such accommodation does not place an "undue
hardship" on the employer's business. Thus, Title VII protects an
employed provider's individual beliefs while ensuring patient access to
services. The Proposed Rule does not provide such balance. Rather, it
tips the scale to the provider -- a consequence that will surely impact
the underserved and most vulnerable patients with little (or no)
choices.[^4]

Given the overly broad, and at times vague and ambiguous language of the
Proposed Rule, NACHC believes that it will ultimately result in the very
behaviors HHS hopes to avoid -- intolerance of individual beliefs,
institutionalizing of cultural insensitivity, and limitation (and, in
many cases, restriction) of patient access to care. By not only
codifying, but also expanding (or, in the case of Title VII, ignoring)
current law, the Proposed Rule goes well beyond its stated scope and
purpose. Rather than simply protecting providers from discrimination
based on religious beliefs, it broadly protects all health care staff
(clinicians and support staff) from being required to perform or
participate in any service related to the provision of health care
services regardless of how attenuated the connection (or from reprisals
based on refusal to do the same) so long as the affected individual
deems the activity religiously or morally objectionable -- without any
limitation. In doing so, HHS goes beyond Congressional intent in
enacting current protections, disregarding the needs of patients in
favor of the beliefs of providers/staff while inappropriately expanding
the scope of current protections.

For the reasons discussed below, NACHC believes that the Proposed Rule
would be particularly harmful for health centers. The Proposed Rule is
contrary to and conflicts with health centers' service obligations
required under Section 330 (and some state laws), jeopardizes access to
and availability of essential health care services for
medically-underserved populations and areas (in terms of availability of
both services and providers) in a manner that disproportionately impacts
the poorest and most vulnerable populations among us, and generally
undermines the health care safety-net. If finalized, the Proposed Rule
would place health centers in a conundrum -- unable to comply with both
the Rule and their Section 330-related obligations, health centers would
be subject to penalty, sanction and/or jeopardizing of their grants
regardless of which actions they take. **Thus, NACHC strongly urges HHS
to withdraw the Proposed Rule in its entirety**.

If, however, HHS decides to proceed with a final rule, NACHC requests
that HHS specifically exempt health centers from its application to
ensure that the centers can continue to serve and provide essential
access to care to their medically underserved populations free from fear
of penalty, sanction or jeopardizing of Section 330 grant funds. Short
of a complete exemption, NACHC requests that , at a minimum, HHS take
the following actions:

-   Modify the scope of the final rule to limit it to current law, thus
    making the rule consistent with its stated purpose and providing a
    balance between protecting individual beliefs and ensuring patient
    access to services.

-   Modify the application of the final rule to clarify that it will
    apply only to the extent that it is not contrary to and does not
    conflict with requirements of the HHS program for which the affected
    entity receives federal funds. Should the affected entity determine
    such conflict exists, NACHC requests clarification that the HHS
    program requirements will take precedence over the final rule.

-   Modify the definition of "assist in the performance" to clarify that
    it applies solely to assistance furnished during the actual
    provision of clinical services, thus excluding support services that
    facilitate patient access to care (*e.g.*, such as case management,
    referrals, registration and intake, counseling, *etc.*).

-   Clarify the scope of "lawful sterilization procedure or abortion" to
    ensure that it does not impede the provision of lawful
    counseling/referral activities as well as certain services related
    to sterilization (*e.g.*, tubal ligations and vasectomies) and/or
    reproductive and contraceptive services (including emergency
    contraceptive services in cases of rape and incest)

-   Given the potentially broad scope of "moral conviction," add
    parameters/guidelines regarding what would and would not constitute
    instances of "moral conviction" to ensure that individuals cannot
    unjustifiably claim this as grounds to not perform or assist with a
    service that the individual simply does not want to provide.

**The Proposed Rule Is Contrary to and Conflicts with Section
330-Related Service Requirements**

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:

-   "\[R\]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."[^5] \[73
    *Fed. Reg.* 50283; Section 88.4(d)(1)\]

-   Discriminating against an institution or individual health care
    entity "on the basis that the health care entity does not provide,
    pay for, provide coverage of, or refer for abortion as part of the
    federal program for which it receives funding."[^6] \[73 *Fed. Reg.*
    50283; Section 88.4(b)(2)\]

The substantial negative impact of these prohibitions is compounded by
both broad definitions of certain key terms as well as the lack of
definition of others. In particular, "assist in the performance" is
defined to mean participation "in any activity with a reasonable
connection to a procedure, health service or health service program, or
research activity, so long as the individual involved is a part of the
workforce of a Department-funded entity. This includes counseling,
referral, training, and other arrangements for the procedures, health
service or research activity." \[73 *Fed. Reg.* 50282; Section 88.2\].
Similarly, "workforce" is broadly defined to include "employees,
volunteers, trainees, and other persons whose conduct, in the
performance of work for a Department-funded entity, is under the control
or authority of such entity, whether or not they are paid by the
Department-funded entity." \[73 *Fed. Reg.* 50282-3; Section 88.2\].
What are not defined, however, are the terms "religious belief," "moral
conviction," "abortion" and "sterilization.

When these definitions and omissions are viewed together, it is no
exaggeration to suggest that virtually any service (clinical and
non-clinical support services) provided by any health center staff (paid
and non-paid) may be impacted by the Proposed Rule. As discussed above,
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 (including, among other services,
voluntary family planning services and immunizations), as well as a full
complement of non-clinical services to support patient access. Further,
in serving underserved populations, health centers often provide a broad
spectrum of care, including potentially life-saving treatment to
patients suffering from sexually transmitted diseases, HIV/AIDs and
other chronic conditions prevalent in low-income, indigent populations.

In addition to providing services directly, health centers typically
utilize a wide network of community providers to assist in providing
services that the health center does not (or cannot) provide. Thus,
referral systems, counseling and case management are of vital importance
to health center patients, many of whom would not be able to navigate an
increasingly complex health care system without assistance from the
health center. By broadly defining "assist in the performance" to
include various forms of patient assistance, health centers will not
only be limited in furnishing required and other necessary clinical
services, but will also be limited in providing appropriate (and
required) aid.

The Proposed Rule does not explicitly restrict health centers from
providing these services. However, if health care personnel and support
staff are allowed to "opt-out" of performing services which they find
objectionable, effectively health centers will be unable to meet their
statutory and regulatory obligations to furnish required services to all
residents of their service area, as well as other services which they
are "ethically" bound to provide (*e.g.*, treatments for STDs, HIV/AIDs
and other chronic conditions) and which support patient access to care
(*e.g.*, referrals and case management). Adding to this dilemma, given
the shortage of available health care professionals in many of the
medically underserved communities in which health centers are located,
health centers may be unable to find any locally-available providers
willing to furnish these services.

For example, health centers are required to provide access to childhood
immunizations, either directly or through established arrangements
within the community. If a health center's provider staff refuses to
administer immunizations due to moral / religious convictions and there
are no adequate alternatives in the community, the health center would
be non-compliant with its legal requirements under its Section 330
grant. Even when appropriate local alternatives are available, if the
health center staff refuses to provide referrals to these other
providers, effectively access will be denied. Finally, if the front desk
person has religious / moral objections to vaccinations and thus,
refuses to register a patient presenting for his/her immunizations,
patient access will be denied -- he/she will not even "get in the door"
-- regardless of whether the providers are willing and able to
administer the vaccinations.

The examples of how the Proposed Rule could impact a health center's
ability to provide required services (and ultimately, patient access)
are numerous -- providers who refuse to treat sexually transmitted
diseases, providers who refuse to provide family planning services,
including birth control, pharmacists who refuse to fill prescriptions
for HIV/AIDs, front desk staff who refuse to schedule appointments for
undocumented patients, *etc.* In fact, under the Proposed Rule, not only
could providers limit or restrict the provision of services, they also
could justify a refusal to inform or counsel patients regarding
available options, thus affecting the ability of patients to make
informed decisions regarding their health care.

Given the breadth of the prohibitions cited above and the vagueness of
certain terms, NACHC 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.

**The Proposed Rule Jeopardizes Access to and Availability of Essential
Health Care Services for Underserved Populations**

In limiting the health centers' ability to provide the array of clinical
and non-clinical services required by Section 330 (as well as other
services appropriate for the needs of their populations), the Proposed
Rule negatively impacts access to and availability of essential health
care services for medically underserved populations. Often, health
centers are one of the few (or the only) health care providers willing
and able to furnish services to underserved and vulnerable populations
residing in their communities. As discussed above, a core requirement of
the health center program is locating in or serving an MUA/MUP; a vast
number of health centers also serve HPSAs. These labels are indicators
of need within a community -- their mere existence demonstrates that an
area or population is underserved. By restricting or limiting the
services a health center can provide, the Proposed Rule effectively
closes off a vital source of health care for this country's most
vulnerable populations. Effectively, the Proposed Rule
disproportionately impacts the populations with the fewest health care
options -- low-income, indigent and minority populations that, if not
for health centers, would potentially be without or forgo the receipt of
essential health care services.

In addition to limiting the services themselves, access could be
significantly reduced by limiting the ability of health centers to
maintain the core staff of providers and support personnel necessary to
furnish the services. In particular, the Proposed Rule prohibits health
centers from:

-   Discriminating "against any physician or other health care
    professional in the employment, promotion, termination or extension
    of staff privileges because he performed or assisted in the
    performance, or refused to perform or assist in the performance of a
    lawful sterilization procedure or abortion on the grounds that doing
    so would be contrary to his religious beliefs or moral convictions,
    or because of his religious beliefs or moral convictions concerning
    abortions or sterilization procedures themselves."[^7] \[73 *Fed.
    Reg.* 50283; Section 88.4(c)(1)\].

This provison prohibits employment discrimination based solely on
performance of or refusal to perform sterilization and abortion
procedures. However, given that health centers often employ
professionals who perform a myriad of procedures within their fields, it
is not difficult to conceive of a situation under which this prohibition
would impact the employment of an obstetrician/ gynecologist, family
practitioner, pediatrician, internist, pharmacist, behavioral health
professional who may be asked to provide services related to
sterilization (*e.g.*, tubal ligations and vasectomies) and/or
reproductive and contraceptive services (including emergency
contraceptive services in cases of rape and incest), but who may claim a
religious or moral objection to providing such services.

It is our understanding that the Proposed Rule does not prohibit the
manner by which health centers hire, fire, or promote staff performing
services other than sterilization and abortion. However, given that the
Proposed Rule prohibits requiring individuals to perform or assist in
the performance of any objectionable health service and the shortage of
health professionals with which health centers deal every day, NACHC
believes that all of the health centers' employment decisions
effectively will be limited.

**The Proposed Rule Could Undermine the Health Care Safety-Net for
Millions**

As discussed above, the restriction of vital services results in a human
toll on the populations served, striking the most vulnerable among us --
those without access to and availability of health care choices. If such
restriction jeopardizes a center's Section 330 funds, both health
centers and their patients will face not only a crisis of access but
also a financial toll on their communities -- a threat to the economic
health of an already underserved and depressed community, including loss
of jobs within the community, loss of revenue to stimulate the local
economy, foreclosures impacting the local banking industry, just to name
a few potential results.

A recent study of the impact that investment in community health centers
has on the economy indicated that for every \$1 in grant funding
received by the health center, it earned approximately \$3 in third
party revenue (and approximately \$4 if additional federal, state and
local grants and contracts are included).[^8] This return on investment
translates into, among other things, additional health care services,
new community jobs and significant investment in non-health care-related
community services and supplies. Thus, health centers are not only
important safety-net providers, but also economic engines fueling their
respective communities -- just as increased investment in health centers
stimulates the local economy, loss of centers would more than likely
depress it.

**Conclusion**

NACHC understands the importance of recognizing and protecting the
legitimate concerns of health care professionals (and other personnel)
faced with providing or assisting with services which they find
religiously or morally objectionable. However, we believe that HHS is
misguided in its attempts to codify protections already in law, while
expanding those protections well-beyond current law and statutory intent
as well as the stated scope and intent of the Proposed Rule itself.
Ultimately, NACHC believes that these efforts -- regardless of any good
intention behind them -- will result in the very harm HHS is trying to
avoid.

The Proposed Rule would be particularly harmful for health centers
serving medically underserved communities nationwide -- it is contrary
to and conflicts with health centers' service obligations required under
Section 330, jeopardizes access to essential health care services for
medically-underserved populations and areas, and generally undermines
the health care safety-net. If finalized, the Rule would place health
centers in a position of having to choose whether to comply with the
Rule or with their Section 330-related obligations, subjecting centers
to penalties, sanctions and/or jeopardizing of their grants regardless
of which actions are taken. **For all of these reasons, NACHC strongly
urges HHS to withdraw the Proposed Rule in its entirety**.

If, however, HHS decides to proceed with a final rule, NACHC requests
that HHS specifically exempt health centers from its application to
ensure that the centers can continue to serve and provide essential
access to care to their medically underserved populations free from fear
of penalty, sanction or jeopardizing of Section 330 grant funds. Short
of a complete exemption, at a minimum, NACHC requests that HHS modify
the rule as identified upfront in this comment to ensure that
appropriate safeguards are in place to protect patient access while
simultaneously protecting individual beliefs.

Thank you for the opportunity to comment on these proposed rules. If you
have any questions about the contents of this document, please call or
email me at 202-296-0158; <rschwartz@nachc.com> .

Sincere ly,

![](media/image2.wmf){width="0.9680555555555556in"
height="0.4791666666666667in"}

Roger Schwartz

Associate Vice President of Executive Branch Liaison

[^1]: In addition to those health centers receiving grant funds pursuant
    to one or more of the Section 330 funding programs, there are
    certain entities that are designated by the Centers for Medicare and
    Medicaid Services (CMS) as FQHCs, by virtue of the fact that they
    meet all of the requirements to receive a Section 330 grant, but do
    not receive funding from HRSA. For purposes of this comment, unless
    otherwise noted, we do not distinguish between grantees and FQHC
    look-alike entities, collectively referring to both types of
    organizations as "FQHCs" or "health centers."

[^2]: There are certain exceptions to this requirement for health
    centers that receive grant funds solely to serve migrant and
    seasonal farmworkers, homeless individuals and families, and/or
    residents of public housing.

[^3]: We also note that health centers that are accredited by the Joint
    Commission are required to identify ethical issues and develop and
    implement a process to handle such issues, which includes assurance
    that patient care, treatment and services will not be negatively
    affected when a staff member is excused from participation.

[^4]: The Proposed Rule also ignores the interplay with Title VII,
    leaving one to wonder which rule governs -- a consequence which HHS
    could not have intended.

[^5]: This prohibition applies to any entity that "\[C\]arries out any
    part of any health service program or research activity funded in
    whole or in part under a program administered by \[HHS\] ...." \[73
    *Fed. Reg.* 50283; Section 88.3(g)(1)\].

[^6]: This prohibition applies to any entity that "\[R\]eceives federal
    funds appropriated through the appropriations act of \[HHS} to
    implement any part of any federal program ...." \[73 *Fed. Reg.*
    50283; Section 88.3(c)\].

[^7]: This prohibition applies to any entity that "\[R\]eceives a grant,
    contract, loan, or loan guarantee under the Public Health Service
    Act...." \[73 *Fed. Reg.* 50283; Section 88.3(f)(1)\]

[^8]: *See* Shin, P., Finnegan, B., Rosenbaum, S., *How Does Investment
    in Community Health Centers Affect the Economy?*, Geiger Gibson/RCHN
    Community Health Foundation Research Collaborative, Research Brief
    #1, The George Washington University School of Public Health and
    Health Services, Department of Health Policy (February 25, 2008).