U.S. Department of Health and Human Services
Regulation 45 CFR Part 88 (2008) [Rescinded]
Ensuring That Department of Health and Human Services Funds Do Not
Support Coercive or Discriminatory Policies or Practices in Violation of
Federal Law
From the Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008
/ Rules and Regulations:
Part VI,
78072-78101.
- Note: This commentary refers to a
regulation issued
in December, 2008 by the Bush Administration. It was eviscerated by the
Obama Administration and re-issued in February, 2011. [See
current regulation]
I. Introduction
II. Comments on the Proposed Rule
A. Comments on Proposed New § 88.1- Purpose
B. Comments on Proposed New § 88.2- Definitions
C. Comments on Proposed New § 88.3- Applicability
D. Comments on Proposed New § 88.4- Requirements and Prohibitions
E. Comments on Proposed New § 88.5- Written Certification of Compliance
F. Comments Received in Response to Specific Requests for Comments in the
Proposed Rule
G. General Comments
III. Legal Authority
IV. Section-by-Section Description of the Final Rule
V. Analysis of Economic Impacts
VI. Paperwork Reduction Act of 1995
Headings/comments in red text in square brackets
added by Project Administrator for convenience.
Several provisions of federal law prohibit recipients of certain federal
funds from coercing individuals in the health care field into participating
in actions they find religiously or morallyobjectionable. These same
provisions also prohibit discrimination on the basis of one's objection to,
participation in, or refusal to participate in, specific medical procedures,
including abortionor sterilization. In addition, there is a statutory
provision that prohibits the federal government and State and local
governments from discriminating against individual and institutional
providers who refuse, among other things, to receive training in abortions,
require or provide such training, perform abortions, or refer for or make
arrangements for abortions or training in abortions. More recently, an
appropriations provision has been enacted (and reenacted or incorporated
into every appropriations act since the appropriations act for Fiscal Year
2005) that prohibits certain federal agencies and programs and State and
local governments that receive certain federal funds from discriminating
against individuals and institutions that refuseto, among other things,
provide, refer for, pay for, or cover, abortion. These statutes are
collectively referred to as the ''federal health care conscience protection
statutes.'' This rule isintended to ensure that, in the delivery of health
care and other health services, recipients of Department funds do not
support coercive or discriminatory practices in violation of these laws.
The conscience provisions contained in 42 U.S.C. 300a-7 (collectively known
as the ''Church Amendments'') were enacted at various times during the 1970s
in Response to debates overwhether receipt of federal funds required the
recipients of such funds to perform abortions or sterilizations. The first
conscience provision in the Church Amendments, 42 U.S.C. 300a-7(b),provides
that ''[t]he receipt of any grant,contract, loan, or loan guarantee under
[certain statutes implemented by the Department of Health and Human
Services] * * * by any individual or entity does not authorize any court or
any public official or other public authority to require'':
(1) The individual to perform or assist in a sterilization procedure
or an abortion, if it would be contrary to his/her religious beliefs or
moral convictions;
(2) the entity to make its facilities available for sterilization
procedures or abortions, if the performance of sterilization procedures
or abortions in the facilities is prohibited by the entity on the basis
of religious beliefs or moral convictions; or
(3) the entity to provide personnel for the performance of
sterilization procedures or abortions, if it would be contrary to the
religious beliefs or moralconvictions of such personnel.
The second conscience provision in the Church Amendments, 42 U.S.C.
300a-7(c)(1), prohibits any entity which receives a grant, contract, loan,
or loan guarantee under certain Department implemented statutes from
discriminating against any physician or other health care personnel in
employment, promotion, termination of employment, or the extension of staff
or other privileges because the individual either ''performed or assisted in
the performance of a lawful sterilization procedure or abortion, or because
he refused to perform or assist in the performance of such a procedure or
abortion on the grounds that his performance or assistance in the
performance of the procedure or abortion would be contrary to his religious
beliefs or moral convictions, or because of his religious beliefs or moral
convictions respecting sterilization procedures or abortions.''
The third conscience provision, contained in 42 U.S.C. 300a-7(c)(2),
prohibits any entity which receives a grant or contract for biomedical or
behavioral research under any program administered by the Department from
discriminating against any physician or other health care personnel in
employment, promotion, termination of employment, or extension of staff
orother privileges ''because he performed or assisted in the performance of
any lawful health service or research activity, or because he refused to
perform or assist in the performance ofany such service or activity on the
grounds that his performance of such service or activity would be contrary
to his religious beliefs or moral convictions, or because of his
religiousbeliefs or moral convictions respecting any such service or
activity.''
The fourth conscience provision, 42 U.S.C. 300a-7(d), 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 [the Department] if his
performance or assistance in the performance of such part of such program or
activity would be contrary to his religious beliefs or moral convictions.''
The final conscience provision contained in the Church Amendments, 42
U.S.C. 300a-7(e), prohibits any entity that receives a grant, contract,
loan, or loan guarantee under certainDepartmentally implemented statutes
from denying admission to, or otherwise discriminating against, ''any
applicant (including for internships and residencies) for training or
studybecause of the applicant's reluctance, or willingness, to counsel,
suggest, recommend, assist, or in any way participate in the performance of
abortions or sterilizations contrary to orconsistent with the applicant's
religious beliefs or moral convictions.''
Enacted in 1996, section 245 of the Public Health Service Act (PHS Act)
prohibits the federal government and any State or local government receiving
federal financial assistance fromdiscriminating against any health care
entity on the basis that the entity
(1) refuses to receive training in the performance of abortions, to
require or provide such training, to perform such abortions, or to
provide referrals for such training or such abortions;
(2) refuses to make arrangements for such activities; or
(3) attends or attended a post-graduate physician training program or
any other training program in the health professions that does not (or
did not) perform abortions or require, provide, or refer for training in
the performance of abortions or make arrangements for the provision of
such training. For the purposes of this protection, the statute defines
''financial assistance'' as including, ''with respect to a government
program,'' ''governmental payments provided as reimbursement for
carrying out health related activities.''
In addition, PHS Act § 245 requires that, in determining whether to grant
legal status to a health care entity (including a State's determination of
whether to issue a license or certificate (such as a medical license)), the
federal government and any State or local government receiving federal
financial assistance deem accredited any post-graduate physician training
program that would be accredited, but for the reliance on an accrediting
standard that, regardless of whether such standard provides exceptions or
exemptions, requires an entity:
(1) To perform induced abortions; or
(2) to require, provide, or refer for training in the performance of
induced abortions, or make arrangements for such training.
Weldon Amendment [Consolidated
Appropriations Act, 2008, Public Law110-161, Div. G, § 508(d), 121 Stat.
1844, 2209 (Dec. 26, 2007)]
The Weldon Amendment, originally adopted as section 508(d) of the Labor-HHS
Division (Division F) of the 2005 Consolidated Appropriations Act, Public
Law 108-447 (Dec. 8, 2004), has been readopted (or incorporated by
reference) in each subsequent HHS appropriations act. Title V of the
Departments of Labor, Health and Human Services, and Education, andRelated
Agencies Appropriations Act, 2006, Public Law 109-149, § 508(d), 119 Stat.
2833, 2879-80; Revised Continuing Appropriations Resolution of 2007, Public
Law 110-5, § 2, 121 Stat. 8, 9; Consolidated Appropriations Act, 2008,
Public Law 110-161, Div. G, § 508(d), 121 Stat. 1844, 2209; Consolidated
Security, Disaster Assistance, and Continuing Appropriations Act, 2009,
Public Law 110-329, Div. A, § 101, 122 Stat. 3574, 3575.
The Weldon Amendment provides that ''[n]one of the funds made available
under this Act [making appropriations for the Departments of Labor, Health
and Human Services, and Education] may be made available to a federal agency
or program, or to a State or local government, if such agency, program, or
government subjects any institutional or individual health care entity to
discrimination on the basis that the health care entity does not provide,
pay for, provide coverage of, or refer for abortions.'' It also defines
''health care entity'' to include ''an individual physician or other health
care professional, a hospital, a provider sponsored organization, a health
maintenance organization, a health insurance plan, or any other kind of
health care facility, organization, or plan.''
On August 26, 2008 (73 FR 50274), the Office of the Secretary, Department of
Health and Human Services, published a Notice of Proposed Rulemaking
(proposed rule) entitled, ''Ensuring That Department of Health and Human
Services Funds Do Not Support Coercive or DiscriminatoryPolicies or
Practices In Violation of Federal Law.'' The proposed rule set forth the
purpose of the proposed rule, proposed definitions to clarify the meaning of
statutory requirements, and proposed to require certain recipients and
sub-recipients of Departmental funds to certify their compliance with the
statutory requirements. The Comment: period closed on September 25, 2008.
[Concern about intolerance] As noted in the preamble to the proposed
rule, the Department is concerned about the development of an environment in
sectors of the health care field that is intolerant of individualobjections
to abortion or other individual religious beliefs or moral convictions. Such
developments may discourage individuals from entering health care
professions. Such developments also promote the mistaken belief that rights
of conscience and self-determination extend to all persons, except health
care providers.
[Concern
about discriminatory exclusion/isolation] Additionally, religious
and faith-based organizations have a long tradition of providing medical
care in the United States, and they continue to do so today-some of these
are among the largest providers of health care in this nation. Such
institutions may have traditions of issuing clear public guidance which
informs the members of their workforces, including physicians having
privileges at their institutions, of the parameters under which they should
operate in accordance with the organization's overall mission and ethics. A
trend that isolates and excludes some among various religious, cultural,
and/or ethnic groups from participating in the delivery of health care is
especially troublesome when considering current and anticipated shortages of
health care professionals in many medical disciplines and regions of the
country.
[Concern about access to
care] The Department is committed to its mission of expanding
patient access to necessary health care services. Americans can enjoy
healthier, happier, and more productive lives through access to, and
appropriate utilization of, all of the life-saving and life-improving
procedures and services produced by medical innovation. The Department has a
long history of demonstrated success in facilitating the improvement of
lives in this way.
[Physician-patient
relationship] A necessary element in ensuring the best possible care
for patients is protecting the integrity of the doctor patient relationship.
Patients need full access to their health care provider's best judgment as
informed by practice, knowledge, and experience. This relationship requires
open communication between both parties so patients can be confident that
the care they seek and receive is endorsed by their health care provider. It
is one of the reasons for the common practice of patients meeting with
several health care providers in order to find the one in whom they are most
confident about entrusting their care. This helps ensure patients receive
the care they believe is appropriate, and that doctors provide care that
they are comfortable providing.
[Balancing of interests]
The doctor-patient relationship requires a balancing of interests. The
patient has an interest in obtaining legal health care services-and, in the
context of federally funded health care programs, an eligible patient may
have the right to obtain certain health care services from certain entities.
This must be balanced against the statutory right of the provider in the
context of a federally funded entity to not be discriminated against based
on a refusal to participate in a service to which they have objections, such
as abortion. As stated above, Congress recognized those provider rights in
several statutes.
The Department seeks to ensure this balance through raising awareness of
federal health care conscience protection laws by specifically including
reference to the nondiscrimination provisions contained in the Church
Amendments, PHS Act § 245, and the Weldon Amendment incertifications
currently required of most existing and potential recipients of Department
funds. It also seeks to provide for Departmental enforcement of these three
statutes.
[Intentions of Dept. of HHS]Toward
these ends, the Department has concluded that regulations and related
efforts are necessary, in order to
(1) educate the public and health care providers on the obligations
imposed, and protections afforded, by federal law;
(2) work with State and local governments and other recipients of
funds from the Department to ensure compliance with the
nondiscrimination requirements embodied in the Church Amendments, PHS
Act § 245, and theWeldon Amendment;
(3) when such compliance efforts prove unsuccessful, enforce these
health care conscience protection laws through the various Department
mechanisms currently in existence, to ensure that Department funds do
not support morally coercive or discriminatory practices or policies in
violation of federal law; and
(4) otherwise take an active role in promoting open communication
within the health care field, and between providers and patients,
fostering a more inclusive, tolerant environment in the health care
industry than may currently exist.
[Reproductive health
services] The ability of patients to access health care services,
including abortion and reproductive health services, is long established and
is not changed in this rule. Instead, this rule implements federal laws
protecting health care workers and institutions from being compelled to
participate in, or from being discriminated against for refusal to
participate in, health services or research activities that may violate
their consciences, including abortion and sterilization, by entities that
receive certain funding from the Department. (It also implements the
provisions of federal law which protect health care personnel from being
discriminated against for their participation in any lawful health service
or research activity, including abortion and sterilization, by entities that
receive certain funding from the Department.)
[Transparency] Delivery of health
care services is significantly improved when patients and health care
providers have full, open, and honest conversations about the services they
request and provide. These conversations are particularly useful at the
beginning of a patient provider relationship. This rule should help generate
greater transparency between patients and providers and foster open
discussion, which should strengthen relationships between patients and
providers, as well as those between entities and their employees.
[Scope of rule] This final rule sets
out, and provides further definition of, the rights and responsibilities
created by the federal health care provider conscience provisions. It
clarifies the scope of protections to applicable members of the Department's
workforce, as well as health care entities and members of the workforces of
entities receiving Department funds. This final rule also requires certain
recipients and subrecipients of Department funds to certify compliance with
these federal requirements. In order to ensure proper enforcement, this
final rule defines certain terms for the purposes of this final rule.
[Investigation of
non-compliance] As was stated in the preamble to the proposed rule,
the Office for Civil Rights (OCR) of the Department of Health and Human
Services has been designated to receive complaints of discrimination and
coercion based on the healthcare conscience protection statutes and this
regulation. OCR will coordinate handling of complaints with the staff of the
Departmental programs from which the entity, with respect to whom a
complaint has been filed, receives funding (i.e., Department funding
component). Enforcement of the requirements set forth in this regulation
will be conducted by staff of the Department funding component through the
usual and ordinary program mechanisms. Compliance with the requirements
promulgated herein will likely be examined as part of any broader compliance
review conducted by Department staff.
[Resolution of
non-compliance]If the Department becomes aware that a State or local
government or an entity may have undertaken activities that could lead to
violation of, or may actually be in violation of, the requirements or
prohibitions promulgated herein, the Department will work with such
government or entity to assist such government or entity to comply or come
into compliance with such requirements or prohibitions. If, despite the
Department's assistance, compliance is not achieved, the Department will
consider all legal options, including termination of funding, return of
funds paid out in violation of health care conscience protection provisions
under 45 CFR parts 74, 92, and 96, as applicable.