U.S. Department of Health and Human Services
Regulation 45 CFR Part 88 (2008) [Rescinded]
[Headings/comments in red text in square brackets added by Project
Administrator for convenience.]
On August 26, 2008 (73 FR 50274), Department of Health and Human Services
published the proposed rule.
The Department received a large volume of
Comments on the proposed rule, both from Commenters supporting the proposed
rule, as well as from those opposing the proposed rule.
Comments came from a wide variety of individuals and organizations,
including private citizens, individual and institutional health care
providers, religious organizations, patient advocacy groups, professional
organizations, universities and research institutions, consumer
organizations, and State and federal agencies and representatives.
Comments dealt with a range of issues surrounding the proposed rule,
including the need for the rule; what kinds of workers would be protected by
the proposed rule; what services are covered by the proposed rule; whether
health care workers use the regulation to discriminate against patients;
what significant implementation issues could be associated with the rule;
legal arguments; and the cost impacts of the proposed rule. Many Comments
from health care providers, members of the public, and others confirmed the
need to promulgate this regulation to raise awareness of federal conscience
protections and provide for their enforcement.
A summary of the substantive Comments, and the Department's Responses to
those Comments, follows.
No Comments were received pertaining to this section.
Comments suggested that the proposed definition of ''assist in the
performance'' was too broad. These Comments focused primarily on the
inclusion of referral, training, and other arrangements within the ambit of
this statutory term, claiming that this would allow an individual or
institution to refuse to provide information or counseling about an
objectionable procedure to which he or it objected.
Commenters also expressed concern that the definition was too broad
because, they asserted, a health care provider has an obligation to provide
or assist patients with a referral or other information that allows the
patient to receive health care services, regardless of the health care
provider's conscientious objection.
Commenters raising these concerns may lack understanding of the context in
which the term ''assist in the performance'' is used in the statutes and in
this regulation. The term is only used in the Church Amendments and in the
provisions of this regulation that implement those statutory provisions.
As noted above (see
section I), all provisions of the Church Amendment use the term ''assist
in the performance'' to ensure that individuals are protected from being
required to assist in the performance of certain health care services or
research activities, and from being discriminated against on the basis that
(1) assisted in the performance of a legal health service or research
(2) refused to assist in the performance of such a health service or
research activity because it would be contrary to his religious beliefs
or moral conviction.
Given that context, in interpreting the term ''assist in the
performance,'' the Department has sought to provide broad protection for
individuals, consistent with the plain language of the statutes. As a policy
matter, the Department believes that limiting the definition of the
statutory term ''assist in the performance'' only to those activities that
constitute direct involvement with a procedure, health service, or research
activity, falls short of implementing the protections Congress intended
under federal law.
However, we recognized the potential for abuse if the term was unlimited.
Accordingly, we proposed- and here finalize-a definition of ''assist in the
performance'' that is limited to ''any activity with a reasonable connection
to a procedure, health service or health service program, or research
activity.'' We also finalize the limitation in the definition that required
the individual involved to be ''a part of the workforce of a
We wish to clarify here the scope of federal law respecting the
protections afforded with respect to ''assist[ing] in the performance'' of a
procedure, health service, or research activity.
Whether the relevant provision of the Church Amendments uses the term
''individual'' (42 U.S.C. 300a-7(b)(1), (d)), ''personnel'' (42 U.S.C. 300a-
7(b)(2)(B)), ''any physician or other health care personnel'' (42 U.S.C.
300a- 7(c)(1)-(2)), or applicant [ ] for training or study'' (42 U.S.C.
300a-7(e)), the term ''assist in the performance'' of a procedure, health
service, or research activity applies to people. Thus, the protections of
the Church Amendments with respect to ''assist[ing] in the performance'' of
a procedure, health service, or research activity are afforded only with
respect to people. To the extent such entities' or institutions' refusal to
assist in the performance of such an activity would not be protected by PHS
Act Â§ 245, the Weldon Amendment, or the Church Amendments at section
300a-7(b)(2), such entities or institutions would have to arrange to provide
any information or service otherwise required by law.
questioned whether the proposed definitions of the terms ''individual'' and
''workforce'' are too broad.
Comments suggested that the definitions of these two terms would require
a health care facility to apply the protections to all of its employees and
contractors, no matter how removed their involvement is from the delivery of
abortion or sterilization services. Other Comments expressed concern that
the proposed definition of ''workforce'' would extend the conscience
protections to volunteers and trainees.
Commenters were also concerned that physicians, hospitals, and other
health care institutions may find the definition burdensome in various areas
of their operation (e.g., janitorial services, medical recordkeeping,
security, reception services).
Lastly, Comments asserted that the definition of ''workforce'' needs to
be changed to provide a complete list of the types of individuals who fall
Department believes that its proposed definition of ''individual'' is
consistent with the statutory language and the intent of Congress as gleaned
from an examination of the provisions in context. We had proposed to define
''individual'' as ''a member of the workforce of an entity/health care
As noted above, the term ''individual'' is used in two provisions of the
Church Amendments: 42 U.S.C. 300a-7(b)(1)  and 42 U.S.C.
300a-7(d). In other provisions of the Church Amendments,
Congress chose to use more clearly limiting terms: ''personnel'' (42 U.S.C.
300a-7(b)(2)(B)), ''any physician or other health care personnel'' (42
U.S.C. 300a-7(c)(1)&(2)), or ''applicant  for training or study'' (42
In addition, those other provisions are explicitly limited to
discrimination in the employment/privileging or education/training contexts,
while 42 U.S.C. 300a-7(d) is not so limited: It provides that ''[n]o
individual shall be required to perform or assist in the performance of any
part of a health service program or research activity funded in whole or in
part under a program administered by [HHS]'' if doing so ''would be contrary
to his religious beliefs or moral convictions.'' Given this context, we
believe that Congress did not intend that the term ''individual'' be limited
to employees or health care personnel with privileges at a Department-funded
entity, and that it is reasonable to include volunteers and trainees in the
definition of ''workforce.''
These laws are intended to protect the conscience rights of all
individuals participating in health care services, and research programs and
activities receiving certain federal funds, or that are administered by the
Department. The Department provides a definition of the term ''workforce''
to serve as a limiting criterion to ensure that individuals that are not
under the control of an entity receiving Department funds do not claim the
protection afforded by the statues. We further note that, where the
individual is assisting in the performance of a sterilization procedure or
abortion (or any other health service or research activity) in which the
provisions of the Church Amendments are relevant, the definition of ''assist
in the performance'' further limits the protection to ''any activity with a
reasonable connection to a procedure, health service or health program, or
research activity * * *.''
Thus, we disagree with the Comment that the definitions would require a
health care facility to apply protections to all of its employees and
contractors no matter how far removed from the performance of sterilization
procedures or abortion. The Department acknowledges that these definitions
would include volunteers and trainees.
It is clear that the statutes specifically envision that these
protections apply to training programs, students, and applicants for
training or study in the health professions. Regarding the Comment that
physicians, hospitals or other providers may find it difficult or burdensome
to comply with this requirement, the Department points to the fact that
these requirements are not new, but are rather existing conditions on
certain federal funds that recipients should be following already.
The Department agrees with the Comment that the term ''workforce'' should
provide a complete identification of covered individuals, and will therefore
replace the word ''includes'' with the word ''means'', to provide a clearer
and more definitive definition.
As indicated in the proposed rule- and consistent with the scope of the
Church Amendments, which include physicians and other health care providers
that have privileges with an entity receiving funding from the Department-we
intended the concept of ''workforce'' to include physicians and other health
care providers who have privileges at the entity funded by the Department.
After publication of the proposed rule, it came to the Department's
attention that the language of the ''workforce'' definition may not be clear
on this issue.
Accordingly, to ensure clarity on this point, we are revising the
definition of ''workforce'' by adding at the end ''or health care providers
holding privileges with the entity.'' The definition now reads:
'' 'workforce' means employees, volunteers, trainees, contractors, 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, or health care
providers holding privileges with the entity.
A number of
Comments suggested that the definitions of ''health care entity'' and
''entity'' are too broad and go beyond those in the Public Health Service
Act and the Weldon Amendment. They assert that the Department exceeded its
rule-making authority when it applied the legal standard enunciated in the
Weldon Amendment and Public Health Service Act to ''health care entities''
that are not encompassed by the definitions set forth in those statutes.
Comments also requested that the Department clarify whether a health care
entity includes pharmacists, nurses, occupational therapists, public-health
workers, janitors working for health care entities, and technicians, as well
as psychiatrists, psychologists, counselors, and other mental health
workers, while others suggested that pharmacists should not be included.
Lastly, one Commenter expressed concern that the proposed rule did not
specify what amount of Departmental funding would place an entity under the
purview of these regulations.
Department believes the definitions proposed in the proposed rule and
adopted herein are appropriate and within its authority.
In providing definitions of the term ''health care entity'' in their
statutes, the Weldon Amendment and Public Health Services Act use the word
''include.'' As a matter of statutory drafting and construction, the use of
that word indicates that the list following it is not exhaustive. In seeking
to issue this regulation, the Department thought it would be beneficial to
provide a clear and consistent definition that it would apply when
implementing any of the three statutes.
In proposing the definition, the Department intended it to be
appropriately broad, but did not attempt to specifically list every possible
entity or health profession classification, to avoid the situation that new
health care professional classifications-or current health care professions
inadvertently not listed- were not protected. As such, the Department used
the terms ''health care professional'' and ''health care personnel'' to
cover other professions such as pharmacists, nurses, occupational
therapists, public-health workers, and technicians, as well as
psychiatrists, psychologists, counselors, and other mental health workers.
The Department rejects the suggestion that pharmacists or pharmacies be
specifically excluded from the definition because that would seem
inconsistent with both the text and the purpose of the statutes.
Lastly, the Department is concerned that some Commenters may incorrectly
believe that there is a minimum financial threshold below which entities may
receive a certain amount of Departmental funds without being subject to he
statutory provisions and these implementing regulations. As in other cases,
such as Title VI of the Civil Rights Act of 1964, when an entity elects to
receive any amount of federal funds, that entity agrees to follow all
conditions and rules that apply to the use of those funds or upon which
receipt of the funds is conditioned.
Several Comments declared that the definitions of ''health service'' and
''health service program'' inappropriately expand the scope of the
conscience provisions to all medical treatments or services, biomedical and
behavioral research, activities related to providing medicine, health care,
or other services related to health or wellness (including programs such as
Medicare and Medicaid). Some observed that the definitions include certain
public health programs, such as vaccinations and family planning.
Lastly, other Comments on these proposed definitions suggested that the
definition of ''health service program'' be expanded to specifically include
assisted suicide, transgender-related surgery and assisted reproductive
Commenters' objections to this definition are fundamentally an objection to
the Department's interpretation of the scope of the statutory protections
themselves. We proposed to define ''health service program'' as including
any plan or program that provides health benefits, whether directly, through
insurance, or otherwise, which is funded, in whole or in part, by the
Department, which may include components of programs operated by State or
There is nothing in the statute to suggest that the term ''health service
program'' in 42 U.S.C. 300a-7(d) is to be read narrowly. Moreover, given the
context of the provision in which it appears, while individuals and health
care personnel are protected with respect to their participation in research
activities, it would not be the result of a broad understanding of ''health
service,'' but because such individuals and healthcare personnel are engaged
in performing or assisting in the performance of research activities funded
under programs administered by the Department, which are subject to
statutory protection. See 42 U.S.C. 300a-7(d). The definition and the
statutory protections apply to health services and research activities that
are funded in whole or in part by the Department.
For the Department to adopt a definition that removes protection from
entire programs that are appropriately included in the definition, given the
statutory context, would be inconsistent with our understanding of the
purpose of the statutory provisions. The observation that some of these
programs may involve important public health issues that may be
controversial or objectionable to some is not a justification to eliminate
the statutory protections.
The Comment that seeks the inclusion of ''assisted suicide'' and other
procedures in the definition of ''health service program'' is misinformed.
This definition does not set out a list or description of the types of
procedures to which a protected individual may or may not object, but the
types of programs under which such protection exists.
While the Department had proposed to define the term ''health service,''
the Department has determined that the term is self-explanatory, and that a
definition is not necessary, or may potentially confuse recipients.
Accordingly, we do not finalize a definition of the term.
Comments expressed concern over extending the applicability of the proposed
definitions of ''recipient'' and ''sub-recipient'' to foreign
non-governmental organizations or international organizations (such as
agencies of the United Nations) without reference to existing federal law
governing U.S. foreign policy. These Comments claimed that it could create
confusion among federal agencies about which laws to follow and could lead
to unforeseen foreign policy complications. They added that it may also
create confusion for entities that receive United States funding, but are
located outside of the United States.
Department does not believe a conflict exists between these statutory
requirements and U.S. foreign policy related to the use of federal funds
abroad. To reduce any potential confusion among federal agencies, we
proposed and here finalize a definitions of recipient and sub-recipient
which permit the Department awarding agency to exercise discretion as to
whether the terms include foreign or international organizations (such as
agencies of the United Nations).
Many Commenters asserted the term ''abortion'' should be
defined in the regulation, some believing that, without such definition, the
proposed rule does not provide sufficient information to direct health care
providers to meet the obligations of the requirements. The main division
among Commenters regarding the definition of abortion was whether certain
contraceptive methods or services that have the potential to terminate a
fertilized egg after conception but before implantation are considered
abortion under the proposed rule. Several Commenters claimed that the
proposed rule would seriously jeopardize Title X programs and Medicaid
services if ''abortion'' is not clearly defined to exclude contraceptive
Response: After the full
consideration of Comments on this issue, the Department declines to add a
definition of abortion to the rule. As indicated by the Comments, such
questions over the nature of abortion and the ending of a life are highly
controversial and strongly debated. The Department believes it can enforce
the federal health care conscience protection laws without an abortion
definition just as the Department has enforced Hyde Amendment, Consolidated
Appropriations Act, 2008, Public Law 110-161, Div. G, Â§Â§ 507, 508(a)-(c),
121 Stat. 1844, 2208 (Dec. 26, 2007), abortion funding restrictions without
a formal definition. Additionally, nothing in this rule alters the
obligation of federal Title X programs to deliver contraceptive services to
clients in need as authorized by law and regulation.
Comments requested that
the Department define many other terms or phrases that are used in the
regulation. Some Comments suggested that the Department adopt a narrow
definition of the term ''discrimination'' and make clear that the
reassignment of an employee who states a religious or moral objection to a
certain activity (such as abortion) does not constitute discrimination.
Response: The Department
believes that these terms are sufficiently clear, and do not need further
definition. The Department does not believe that a definition of the
statutory term''discrimination'' is necessary. The term ''discrimination''
is widely understood, and significant federal case law exists to aid
entities in knowing what types of actions do or do not constitute unlawful
The Department expressly rejects the suggestion that the reassignment of
an employee who states a religious or moral objection to a certain activity
(such as abortion) may not constitute discrimination in all cases. Like most
discrimination cases, the outcomes are dependent on the facts. It seems
likely that there are situations where the reassignment of anemployee for
the refusal to perform a specific procedure could constitute unlawful
discrimination. Likewise, the Department recognizes that circumstances exist
where thereassignment of such an employee would not constitute unlawful
We encourage employers subject to the rule to have discussions with their
employees thatlead to mutually agreeable resolutions.
Comments asked that the Department define the terms ''religious belief'' and
''moral conviction'' to ensure that they would not be interpreted broadly.
The Department declines to adopt particular definitions of these terms
because the common definitions are plainly understood, and the Department
intends that common senseinterpretations apply. A well-defined body of
federal law exists in this general topic, and the U.S. Supreme Court has
repeatedly clarified that these terms are to be read broadly.
No Comments were received specifically pertaining to this section.
No Comments were received specifically pertaining to this section.
Several Comments stated that the requirement for written
certification in proposed section 88.5 would be duplicative or unnecessary
because current regulations alreadyrequire written certification of
compliance with federal nondiscrimination and civil rights laws.Other
Comments suggested that the certifications be modified in order to avoid
confusion on the part of recipients and sub-recipients.
Response: We find that a specific written certification is
necessary to protect institutions under these laws. Many recipients (and
sub-recipients) of Department funds currently must certify compliance with
certain listed federal nondiscrimination laws, yet federal health care
conscience protection laws are separate laws not specifically mentioned in
existing forms. As part of a broad effort to raise awareness in the public,
in the health care community,among recipients of Department funds, and among
protected individuals and institutions, of their rights and responsibilities
under existing federal health care conscience protection laws,as well as to
facilitate enforcement of these laws, the regulation requires certain
recipients and sub-recipients of Department funds to certify their
compliance in writing. Whereverpossible, Department programs will attempt to
integrate certifications required under this regulation into existing forms.
The Department has modified the certifications in section 88.5. They have
been made clear so that recipients and sub-recipients know, by means of the
certifications themselves, with whichprovisions they must comply based on
the type of entity the recipient is or the type of funding mechanism through
which they receive funds.
Comment: Comments asserted that the Department is overstepping its
authority by making compliance with the federal health care conscience
protection statutes a condition of payment, stating Congress has not made
compliance a condition of payment and would havesaid so if that were its
Response: The Department disagrees that the proposed rule exceeds
its authority. It is important to emphasize that the Department and
recipients of Department funds, including State and local governments, are
obligated to comply with the health care protection of conscience laws that
have been in effect for many years, which prohibit federal funds from being
used in a discriminatory or coercive manner against institutional and
individual health care entities and workers for their participation or
refusal to participate in abortions, other certain medical procedures,
health services, or research activities that they find objectionable on
religious or moral grounds. By employing existing regulatory enforcement
measures to ensurecompliance with such statutory requirements under 45 CFR
parts 74, 92, and 96, as well as other measures, the Department does not
exceed its authority, but rather is carrying out itsobligation to enforce
This regulation implements existing federal health care
conscience protection laws contained in the Church Amendments, the Public
Health Service Act Â§ 245 and the Weldon Amendment. Several Comments objected
to the regulation on the grounds that these laws were sufficient in
themselves and that their implementation by regulation was unnecessary or
redundant. Generally, these Comments suggested that the health care field is
sufficiently aware of the statutory protections available for provider
conscience, and that no furtherregulatory effort was required in order to
provide awareness of these laws or to assure compliance with them.
other Comments, however, reported widespread lack of knowledge
regardingthese laws and inconsistent application of them. These Comments
generally supported the regulation as a necessary and useful mechanism to
support statutory protection. In addition,numerous Comments reported what
they believed to be individual instances of violation of conscience,
including health care providers suffering loss of employment, adverse
actions during medical training, and discrimination in residency placement,
among other consequences, due to their assertion of their conscience rights.
Some Commenters also reported pressure toperform certain procedures from
State authorities, professional organizations, or employers that appeared to
the Commenters to be inconsistent with federal conscience protections.
Response: The Comments received in Response to the proposed rule
support the Department position that the regulation is necessary to
implement the statutes.
While many people in the health care field may have general knowledge
that conscience protections exist for providers, the scope of these
protections is not always widely understood. Because Congress has enacted
several different protections, an individual or organization may be aware
that, for instance, a physician may not be compelled to perform abortions,
but may not be aware of other aspects of the statutes providing conscience
protection. Others may become aware of these laws, at least in detail, only
when a dispute arises and a provider or entity attempts to assert their
conscience rights; there may be subsequent disagreement over the nature of
the rights asserted.
The Department believes that coordinating the several related statutory
protections, by incorporating their various requirements into this
regulation, will allow for greater clarity and awareness of these
protections within the health care field, in conjunction with other public
education efforts connected with this regulation.
In addition, the issuance of a regulation will allow for greater ease of
administration, provide a Departmental point of contact for complaints
regarding violations of the statutes and this regulation, and provide a
uniform mechanism for investigating complaints of noncompliance. The types
of noncompliance reported by Commenters are expected to be reduced as a
result of this regulation.
Commenters who supported and opposed the rule both noted
that the Department must increase awareness of health care provider
conscientious objection rights, and theobligations this rule may pose for
employers, entities, and States.
Some Commenters also responded to the Department's request for Comments
on methods which may be used by the Department and others to increase
awareness among health care providers of their rights under laws protecting
providers from discrimination for exercising their conscience rights.
Commenters who opposed the rule suggested that, as an alternative to
further federal regulation, the Department should prepare and distribute
informational materials to individual and institutional health care
providers and State and local governments, and make these materials
available on the HHS Web site. A Commenter also proposed that the Department
develop continuing education courses for health care practitioners and
attorneys, and that existing certifications that recipients of Departmental
funds must currently sign could be modified to achieve the objectives of the
Response: The Department agrees that the suggestions offered by
Commenters of mechanisms for improving awareness of conscience rights among
health care providers would increase the effectiveness of the rule. However,
the rule seeks to achieve not only greaterawareness of provider conscience
rights, but also a more consistent understanding of the scope of these
rights (and the corresponding obligations), greater ease of administration,
provision of a Departmental point of contact for complaints regarding
violations of the statutes and this regulation, a uniform mechanism for
investigating complaints of noncompliance, and, as a result, greater
compliance with the laws protecting these rights.
Comment: Commenters who supported the rule also offered
suggestions on how both theDepartment and covered entities could increase
awareness of the legal protections for health care provider conscience.
Among the suggested activities were posting notices in high trafficareas of
buildings receiving Department funds, providing information within
educationalprograms that receive Department funds, including information in
applications for training, applications for residency programs, and private
insurance plans benefit descriptions,posting information on the Department
or provider Web sites, including of information in employee handbooks, and
sending e-mail or postal communications directly to providers.Comments were
made on how to best attract attention to such postings by making them
distinct from other materials in which they might be included.
Response: The Department agrees that these suggestions would
contribute to significantly greater public awareness of health care provider
conscience protections. The Department encourages covered entities to
undertake such public awareness activities. The Department also recognizes
that it must undertake reasonable outreach efforts in order for the rule to
be effective at increasing awareness of, and compliance with, provider
conscience protections in the statutes and this implementing regulation.
Thus, the Department will consider all avenuesavailable for increasing
public awareness of health care conscience protection laws. Requiring
certification of compliance by entities receiving Department funds provides
an important vehicle for increasing awareness of health care conscience
protection laws and ensuringcompliance with them.
Comment: Some Comments declared that the description of
notice/posting of health care provider conscience protections in the
proposed rule should be enhanced. One argued that posting of notices on
bulletin boards, where they appear among multiple notices, is not avery
effective way of communicating the protections afforded under the regulation
and statutes. Other Comments requested that notices of federal health care
conscience protection statutes should be conspicuous and posted in such
locations as provider offices and pharmacies and in such public
communications as advertising, health plan promotion materials, Medicaid
literature, Web sites, as well as applications for training, residency, and
educational programs, and in employee/volunteer handbooks.
Response: The Department agrees that informing health care
entities of their rights and responsibilities under federal health care
provider conscience provisions is important to ensuringinstitutional and
individual conscience rights are protected. Consequently, the Department
encourages covered entities to undertake such educational/public awareness
activities. Within its statutory authorities, the Department is exploring a
number of options, including many ofthose suggested by Comments as well as
others, to provide further public education and notice of federal health
care conscience protection laws and this regulation.
Several Comments expressed concern that the certification
requirement would create an administrative burden, and one Commenter
suggested that the Department should not impose the certification
requirements of the regulation on every Department granteeregardless of the
Response: In its Notice of Proposed Rule Making, the Department
solicited Comments on whether further exceptions should be made from
certification requirements for recipientsor sub-recipients of federal funds,
where such recipients or sub-recipients receive Department funds for
purposes unrelated to the provision of health care or medical research.
Because there is concern among Commenters over any burden of a
certification, including that stemming from certifications required without
regard to a grant's purpose, and because there appears to be little
objection to limiting the certification requirement in the way put forth
forComments in the proposed rule, the Department has determined to make
further exceptions to the certification requirement for Departmental
programs whose purpose is unrelated to healthcare provision, including
certain programs currently administered by the Administration for Children
and Families and the Administration on Aging.
These programs often involve the provision of grants to States and other
governments, or cash assistance or vouchers rather than direct services, and
they are not likely to involve medical research, the participation of health
care providers, or referral to health care providers. These programs are
unlikely to encounter the circumstances contemplated by this regulation, and
therefore the assurance of compliance represented by a certification is not
considered necessary by the Department for such programs.
The regulatory text has been changed by addition of sections 88.5(e)(4)
and (e)(5), together with associated language and example programs in the
preamble. Finally, in section 88.5(e)(6), we provide an exception from the
written certification requirement for Indian tribes and tribal Organizations
when contracting with the Indian Health Service under the Indian
Self-Determination and Education Assistance Act. Of course, these entities
must still comply with the relevant statutes, even if they are not under an
obligation to make a certification.
The Department requested Comments on whether written
certification of compliance with nondiscrimination provisions should contain
language specifying that the certification is a material prerequisite to the
payment of Department funds. The Department received a number of Comments in
Response to this request, both in favor of and against including such
language in the written certification of compliance.
Those in favor of including material prerequisite language felt that such
language was important as part of the written certification process to
protect individuals and institutions from discriminatory treatment. Others
stated that certification should not be a prerequisite for Department
funding, noting that explicitly tying payment to compliance with the
certification requirement would subject the certification process to the
federal False Claims Act.
One Commenter stated that, absent more explicit guidance on the policies
and practices that will satisfy compliance, written certification should not
be a material prerequisite to payment of Department funds.
Response: The Department does not consider the written
certification of compliance to be a material prerequisite to the payment of
Department funds any more than in any other similarly worded statute or
regulation. As stated above, the Department intends to work with recipients
and sub-recipients of Department funds to ensure compliance with the
requirements or prohibitions promulgated in this regulation, and, if such
assistance fails to achieve compliance, the Department will consider all
legal options, including termination of funding and return offunds paid out
in violation of health care conscience protection provisions under 45 CFR
parts 74, 92, and 96, as applicable.