[Federal Register Volume 76, Number 36 (Wednesday, February 23, 2011)]
[Rules and Regulations]
[Pages 9968-9977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3993]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 88
RIN 0991-AB76
Regulation for the Enforcement of Federal Health Care Provider
Conscience Protection Laws
AGENCY: Office of the Secretary, HHS.
ACTION: Final rule.
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SUMMARY: The Department of Health and Human Services issues this final
rule which provides that enforcement of the federal statutory health
care provider conscience protections will be handled by the
Department's Office for Civil Rights, in conjunction with the
Department's funding components. This Final Rule rescinds, in part, and
revises, the December 19, 2008 Final Rule entitled ``Ensuring That
Department of Health and Human Services Funds Do Not Support Coercive
or Discriminatory Policies or Practices in Violation of Federal Law''
(the ``2008 Final Rule''). Neither the 2008 final rule, nor this final
rule, alters the statutory protections for individuals and health care
entities under the federal health care provider conscience protection
statutes, including the Church Amendments, Section 245 of the Public
Health Service Act, and the Weldon Amendment. These federal statutory
health care provider conscience protections remain in effect.
DATES: This rule is effective March 25, 2011.
FOR FURTHER INFORMATION CONTACT: Georgina Verdugo, Director, Office for
Civil Rights, Department of Health and Human Services, 202-619-0403,
Room F515, Hubert E. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
II. Background
III. Proposed Rule
IV. Comments on the Proposed Rule
A. Scope of Comments
B. Comments Addressing Awareness and Enforcement
[[Page 9969]]
C. Comments Addressing the Underlying Statutes and Other Law
D. Comments Addressing Whether the 2008 Final Rule Clarified the
Provider Conscience Statutes
E. Comments Addressing Access to Health Care
F. Comments Addressing Costs to Providers
V. Statutory Authority
VI. Overview and Section-by-Section Description of the Final Rule
VII. Impact Statement and Other Required Analyses
VIII. Paperwork Reduction Act Information Collection
I. Introduction
The Department supports clear and strong conscience protections for
health care providers who are opposed to performing abortions. While
Federal health care provider conscience statutes have been in effect
for decades, the Department has received comments suggesting that the
2008 final rule attempting to clarify the Federal health care provider
conscience statutes has instead led to greater confusion. The comments
received suggested that there is a need to increase outreach efforts to
make sure providers and grantees are aware of these statutory
protections. It is also clear that the Department needs to have a
defined process for health care providers to seek enforcement of these
protections.
The Department seeks to strengthen existing health care provider
conscience statutes by retaining that part of the 2008 Final Rule that
established an enforcement process. At the same time, this Rule
rescinds those parts of the 2008 Final Rule that were unclear and
potentially overbroad in scope. This partial rescission of the 2008
Final Rule does not alter or affect the federal statutory health care
provider conscience protections.
Finally, the Department is beginning an initiative designed to
increase the awareness of health care providers about the protections
provided by the health care provider conscience statutes, and the
resources available to providers who believe their rights have been
violated. The Department's Office for Civil Rights will lead this
initiative, and will collaborate with the funding components of the
Department to determine how best to inform health care providers and
grantees about health care conscience protections, and the new process
for enforcing those protections.
II. Background
Statutory Background
The Church Amendments, Section 245 of the Public Health Service
Act, and the Weldon Amendment, collectively known as the ``federal
health care provider conscience protection statutes,'' prohibit
recipients of certain federal funds from discriminating against certain
health care providers based on their refusal to participate in health
care services they find religiously or morally objectionable. Most of
these statutory protections have existed for decades. Additionally, the
Patient Protection and Affordable Care Act, Public Law 111-148, 124
Stat. 119 (2010), as amended by Health Care and Education
Reconciliation Act of 2010, Public Law 111-152, 124 Stat. 1029 (2010)
(collectively referred to as the ``Affordable Care Act'') includes new
health care provider conscience protections within the health insurance
exchange system.
Conscience Clauses/Church Amendments [42 U.S.C. 300a-7]
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 to make clear that receipt of Federal
funds did not require 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 the receipt by an
individual or entity of any grant, contract, loan, or loan guarantee
under certain statutes implemented by the Department of Health and
Human Services does not authorize a court, 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 the individual's 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 or
assistance in the performance of sterilization procedures or abortions,
if it would be contrary to the religious beliefs or moral convictions
of such personnel.
The second conscience provision in the Church Amendments, 42 U.S.C.
300a-7(c)(1), extends protections to personnel decisions and prohibits
any entity that 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 ``performed or assisted in the
performance of a lawful sterilization procedure or abortion, 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), goes beyond abortion and sterilization and prohibits any
entity that 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
or other privileges ``because he performed or assisted in the
performance of any lawful health service or research activity, because
he refused to perform or assist in the performance of any such service
or activity on the grounds that his performance or assistance in the
performance of such service or activity would be contrary to his
religious beliefs or moral convictions, or because of his religious
beliefs 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, loan guarantee, or interest subsidy under certain
Departmentally implemented statutes from denying admission to, or
otherwise discriminating against, ``any applicant (including applicants
for internships and residencies) for training or study because 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 or
[[Page 9970]]
consistent with the applicant's religious beliefs or moral
convictions.''
Public Health Service Act Sec. 245 [42 U.S.C. 238n]
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 from discriminating against any
health care entity on the basis that the entity:
1. Refuses to undergo training in the performance of induced
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 program of training in the health professions,
that does not (or did not) perform induced abortions or require,
provide, or refer for training in the performance of induced 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 sec. 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), the federal government and any state or local
government receiving federal financial assistance shall deem accredited
any postgraduate 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
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, 118 Stat. 2809, 3163 (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, and Related Agencies Appropriations Act,
2006, Public Law 109-149, Sec. 508(d), 119 Stat. 2833, 2879-80 (Dec.
30, 2005); Revised Continuing Appropriations Resolution of 2007, Public
Law 110-5, Sec. 2, 121 Stat. 8, 9 (Feb. 15, 2007); Consolidated
Appropriations Act, 2008, Public Law 110-161, Div. G, Sec. 508(d), 121
Stat. 1844, 2209 (Dec. 26, 2007); Consolidated Security, Disaster
Assistance, and Continuing Appropriations Act, 2009, Public Law 110-
329, Div. A, Sec. 101, 122 Stat. 3574, 3575 (Sept. 30, 2008);
Consolidated Appropriations Act, 2010, Public Law 111-117, Div. D, Sec.
508(d), 123 Stat. 3034, 3279-80 (Dec. 16, 2009). The Weldon Amendment
provides that ``[n]one of the funds made available in 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.''
Affordable Care Act
The Affordable Care Act includes new health care provider
conscience protections within the health insurance Exchanges. Section
1303(b)(4) of the Act provides that ``No qualified health plan offered
through an Exchange may discriminate against any individual health care
provider or health care facility because of its unwillingness to
provide, pay for, provide coverage of, or refer for abortions.'' Like
the other statutory health care provider conscience protections, this
provision of law does not require rulemaking to take effect, and
continues to apply notwithstanding this partial rescission of the 2008
Final Rule.
A recent Executive Order affirms that under the Affordable Care
Act, longstanding federal health care provider conscience laws remain
intact, and new protections prohibit discrimination against health care
facilities and health care providers based on their unwillingness to
provide, pay for, provide coverage of, or refer for abortions.
Executive Order 13535, ``Ensuring Enforcement and Implementation of
Abortion Restrictions in the Patient Protection and Affordable Care
Act'' (March 24, 2010).
Regulatory Background
No regulations were required or necessary for the conscience
protections contained in the Church Amendments, PHS Act, sec. 245, and
the Weldon Amendment to take effect. Nevertheless, on August 26, 2008,
nearly forty years after enactment of the Church Amendments, the
Department issued a proposed interpretive rule entitled ``Ensuring that
Department of Health and Human Services Funds Do Not Support Coercive
or Discriminatory Policies or Practices in Violation of Federal Law''
(73 FR 50274).
In the preamble to the 2008 Final Rule, the Department concluded
that regulations were 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 Federal health care
provider conscience protection statutes;
3. When such compliance efforts prove unsuccessful, enforce these
nondiscrimination laws through the various Department mechanisms, to
ensure that Department funds do not support 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 industry, and between providers and patients,
fostering a more inclusive, tolerant environment in the health care
industry than may currently exist.
(``Ensuring That Department of Health and Human Services Funds Do Not
Support Coercive or Discriminatory Policies or Practices in Violation
of Federal Law,'' 73 FR 78072, 78074, 45 CFR part 88 (Dec. 19, 2008)).
The 2008 Final Rule was published in the Federal Register on
December 19, 2008. The Rule contained definitions of terms used in the
federal health care provider conscience statutes, discussed their
applicability, noted the prohibitions and requirements of the statutes,
and created an enforcement mechanism. The 2008 Final Rule also imposed
a new requirement that all recipients and subrecipients of Departmental
funds had to submit written certification that they would operate in
compliance with the provider conscience statutes. This new
[[Page 9971]]
requirement was based on a concern that there was a lack of knowledge
in the health care community regarding the rights and obligations
created by the federal health care provider conscience protection
statutes. The Department received a number of comments expressing
concern that this new certification would impose a substantial burden.
The 2008 Final Rule went into effect on January 20, 2009 except that
its certification requirement never took effect, as it was subject to
the information collection approval process under the Paperwork
Reduction Act, which was never completed.
Pending Litigation
In a consolidated action filed in the U.S. District Court for the
District of Connecticut, eight states and several organizations
challenged and sought to enjoin enforcement of the 2008 Final Rule by
the Department. According to plaintiffs, in promulgating the 2008 Final
Rule, HHS exceeded its statutory authority, violated the Administrative
Procedure Act (APA) by failing to respond adequately to public
comments, and conditioned the receipt of federal funds on compliance
with vague and overly broad regulations. The Court granted a stay of
all proceedings in this litigation pending the issuance of this Final
Rule. Connecticut v. United States, No. 3:09-CV-054-RNC (D. Conn).
III. Proposed Rule
On March 10, 2009, the Department proposed rescinding, in its
entirety, the 2008 Final Rule entitled ``Ensuring That Department of
Health and Human Services Funds Do Not Support Coercive or
Discriminatory Policies or Practices in Violation of Federal Law'' (74
FR 10207). The Department sought public comment in order to determine
whether or not to rescind the 2008 Final Rule in part or in its
entirety. In particular, the Department sought comment addressing the
following:
1. Information, including specific examples where feasible,
addressing the scope and nature of the problems giving rise to the need
for federal rulemaking and how the current rule would resolve those
problems;
2. Information, including specific examples where feasible,
supporting or refuting allegations that the 2008 Final Rule reduces
access to information and health care services, particularly by low-
income women;
3. Comment on whether the 2008 Final Rule provides sufficient
clarity to minimize the potential for harm resulting from any ambiguity
and confusion that may exist because of the rule; and
4. Comment on whether the objectives of the 2008 Final Rule might
also be accomplished through non-regulatory means, such as outreach and
education.
IV. Comments on the Proposed Rule
A. Scope of Comments
The Department received more than 300,000 comments addressing its
notice of proposed rulemaking proposing to rescind in its entirety the
2008 Final Rule. A wide range of individuals and organizations,
including private citizens, health care workers, health care providers,
religious organizations, patient advocacy groups, professional
organizations, universities and research institutions, consumer
organizations, state and local governments, and members of Congress,
submitted comments regarding the notice of proposed rulemaking. The
large number of comments received covered a wide variety of issues and
points of view responding to the Department's request for comments on
the four issues mentioned above, and the Department reviewed and
analyzed all of the comments. The overwhelming majority of comments,
both in support of and against rescission of the 2008 Final Rule, were
form letters organized by various groups. In this section, which
provides an overview of the comments received, and in the following
sections, which provide a more detailed response to these comments, we
respond to comments by issue, rather than by individual comment, as
necessitated by the number of comments received and by the issues posed
by them.
More than 97,000 individuals and entities submitted comments
generally supportive of the proposal to rescind the 2008 Final Rule.
Approximately one-fifth of the comments in favor of rescinding the 2008
Final Rule indicated that the 2008 Final Rule was not necessary,
because existing law, including Title VII of the Civil Rights Act of
1964 and the federal health care provider conscience protection
statutes, already provided protections to individuals and health care
entities. An overwhelming number of these commenters expressed concern
that the 2008 Final Rule unacceptably impacted patient rights and
restricted access to health care and conflicted with federal law, state
law, and other guidelines addressing informed consent. Additionally,
commenters in support of rescinding the 2008 Final Rule contended that
this new regulation imposed additional costs and administrative
burdens, through the certification requirement, on health care
providers when there are already sufficient laws on the books to
protect their rights.
A large number of commenters also expressed concern that the 2008
Final Rule created ambiguities regarding the rights of patients,
providers, and employers. Specifically, a number of commenters noted
that the 2008 Final Rule created ambiguities that could expand the
provider conscience protections beyond those established in existing
federal statutes. Several groups commented that during rulemaking for
the 2008 Final Rule, proponents failed to provide evidence that the
long-standing statutory protections were insufficiently clear or that a
problem currently exists for providers.
Nearly 187,000 comments expressed opposition to the Department's
proposal to rescind the 2008 Final Rule. Nearly 112,000 of these
comments stated that health care workers should not be required to
perform procedures that violate their religious or moral convictions.
Nearly 82,000 of the comments in opposition expressed concern that
without the 2008 Final Rule, health care providers would be forced to
perform abortions in violation of their religious or moral convictions.
Many of these commenters also speculated that eliminating provider
conscience protections would cause health care providers to leave the
profession, which would reduce access to health care services.
Additionally, thousands of commenters suggested that rescinding the
2008 Final Rule would violate the First Amendment religious freedom
rights of providers or the tenets of the Hippocratic Oath, and would
impact the ethical integrity of the medical profession. While the
Department carefully considered these comments, we do not specifically
address them because this partial rescission does not alter or affect
the existing federal statutory health care provider conscience
protections.
Finally, numerous commenters opposing rescission of the 2008 Final
Rule expressed concern that if the 2008 Final Rule was rescinded in its
entirety, there would be no regulatory enforcement scheme to protect
the rights afforded to health care providers, including medical
students, under the federal health care provider conscience protection
statutes.
[[Page 9972]]
B. Comments Addressing Awareness and Enforcement
Need for Enforcement Mechanism
Comment: The Department received numerous comments against
rescission of the 2008 Final Rule expressing concern that if the 2008
Final Rule were rescinded in its entirety, there would be no regulatory
enforcement scheme to protect the rights afforded to health care
providers, including medical students, under the Federal health care
provider conscience protection statutes.
Response: The Department shares the concerns expressed in these
comments, and agrees there must be a clear process for enforcement of
the health care provider conscience protection statutes. While the
longstanding Federal health care provider conscience protection
statutes have provided protections for health care providers, there was
no clear mechanism for a health care provider who believed his or her
rights were violated to seek enforcement of those rights. To address
these comments, this final rule retains the provision in the 2008 Final
Rule that designates the Office for Civil Rights (OCR) of the
Department of Health and Human Services to receive complaints of
discrimination and coercion based on the Federal health care provider
conscience protection statutes.
OCR will lead an initiative across the Department that will include
staff from the Departmental programs that fund grants, in order to
develop a coordinated investigative and enforcement process. OCR is
revising its complaint forms to make it easier for health care
providers to understand how to utilize the complaint process, and will
coordinate the 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 statutory conscience protections will be
conducted by staff of the Department funding component, in conjunction
with the Office for Civil Rights, through normal program compliance
mechanisms. If the Department becomes aware that a state or local
government or an entity may have undertaken activities that may violate
the statutory conscience protections, 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 provider
conscience protection provisions under 45 CFR parts 74, 92, and 96, as
applicable.
Need for Education and Outreach
Comment: The Department's notice of proposed rulemaking for this
final rule requested comment on the need for an education and outreach
program in addition to the promulgation of a regulatory enforcement
scheme. 74 FR 10207, 10210. The Department received many comments
expressing concern about the lack of knowledge about the federal health
care provider conscience protection statutes in the health care
industry. Many commenters opposed to rescission related anecdotes of
hospitals and other health care entities failing to respect the
conscience rights of health care providers. The commenters opined that
if the 2008 Final Rule was rescinded in its entirety, health care
entities receiving federal funding would not honor the rights provided
health care providers under the Federal health care provider conscience
protection statutes.
Response: The Department is concerned about the number of comments
it received that were opposed to rescission of the 2008 Final Rule
based on a belief that rescission of the rule would abolish the long-
standing statutory provider conscience protections as these comments
reflect a lack of understanding that the statutory protections are in
effect irrespective of Department regulations or the 2008 final rule.
The Department believes it is important to provide outreach to the
health care community about the Federal health care provider conscience
protection statutes. To address this need, the Department's Office for
Civil Rights will work with the funding components of the Department to
determine how best to raise grantee and provider awareness of these
longstanding statutory protections, and the newly created enforcement
process.
The Department's Office for Civil Rights currently engages in
outreach and education efforts and works closely with health care
entities to educate them about all of the Federal authorities that the
Office for Civil Rights enforces. The Office for Civil Rights will
include information on the Federal health care provider conscience
protection statutes in such outreach, and will also include information
so that health care entities understand the new process for enforcement
of the Federal health care provider conscience protection statutes. The
Office for Civil Rights provides a Web portal for the receipt of
complaints on its Web site. See Office for Civil Rights, U.S.
Department of Health and Human Services, How to File a Complaint (2010)
(http://www.hhs.gov/ocr/civilrights/complaints/index.html). Combining
the above education and outreach programs with the enforcement
provision in this final rule should ensure that providers can take
advantage of these protections.
The Department is also amending its grant documents to make clear
that recipients are required to comply with the federal health care
provider conscience protection laws.
C. Comments Addressing the Underlying Statutes and Other Laws
Status of Underlying Statutory Conscience Protections
Comment: The Department received a large number of comments, both
in favor of and in opposition to rescinding the 2008 Final Rule, which
expressed concern regarding the effect of the 2008 Final Rule on
protections for providers. Many commenters advocated leaving the final
rule in place, stating that rescinding the 2008 Final Rule would
eliminate the protections for providers established under the Federal
health care provider conscience protection statutes. On the other hand,
many commenters advocated rescission of the 2008 Final Rule based on
the mistaken belief that its rescission would eliminate the ability of
certain providers to refuse to provide requested medical services that
were contrary to their moral or religious beliefs.
Response: These comments underscore the misconceptions that exist
regarding the proposed partial rescission of the 2008 Final Rule, and
highlight the need for continued education and training of health care
providers regarding the longstanding statutory protections. The Federal
health care provider conscience protection statutes, including the
Church Amendments, the Section 245 of the PHS Act, and the Weldon
Amendment, have long provided statutory protections for providers.
Neither the 2008 Final Rule, nor this Final Rule, which rescinds, in
part, and revises the 2008 Final Rule, alters the statutory protections
for individuals and health care entities under the Federal health care
provider conscience protection statutes. Departmental funding
recipients must continue to comply with the Federal health care
provider conscience protection statutes.
[[Page 9973]]
Interaction Between Provider Conscience Statutes and Other Federal
Statutes
Comment: Several other comments raised questions and identified
ambiguities with respect to the interaction between the 2008 Final Rule
and statutes governing other Department programs, including: the
Medicaid program, pursuant to Title XIX of the Social Security Act, 42
U.S.C. 1396-1396v (2006); the Community Health Centers program,
pursuant to section 330 of the PHS Act, 42 U.S.C. 264(b)(2008); the
Title X Family Planning program, pursuant to Title X of the Public
Health Service Act, 42 U.S.C. 300-300a-6 (2006); and the Emergency
Medical Treatment and Labor Act (EMTALA), 42 U.S.C. 1395dd (2003), as
well as the federal civil rights statutes enforced by the Department in
its programmatic settings, which include Title VI of the Civil Rights
Act of 1964, 42 U.S.C. 2000d (1964); Section 504 of the Rehabilitation
Act of 1973, 29 U.S.C. 794 (2002); Title II of the Americans with
Disabilities Act of 1990, 42 U.S.C. 12131-12134 (1990); and the Age
Discrimination Act of 1975, 42 U.S.C. 6101-6107 (1998). Specifically,
commenters expressed concern that the 2008 Final Rule conflicts with
the requirements of these other Federal statutes.
Response: Health care entities must continue to comply with the
long-established requirements of the statutes above governing
Departmental programs. These statutes strike a careful balance between
the rights of patients to access needed health care, and the conscience
rights of health care providers. The conscience laws and the other
federal statues have operated side by side often for many decades. As
repeals by implication are disfavored and laws are meant to be read in
harmony, the Department fully intends to continue to enforce all the
laws it has been charged with administering. The Department is
partially rescinding the 2008 final rule in an attempt to address
ambiguities that may have been caused in this area. The approach of a
case by case investigation and, if necessary, enforcement will best
enable the Department to deal with any perceived conflicts within
concrete situations.
Interaction With Title VII of the Civil Rights Act of 1964
Comment: Several comments raise questions about the overlap between
the federal health care provider conscience protection statutes and the
protections afforded under Title VII of the Civil Rights Act of 1964,
as amended (Title VII), 42 U.S.C. 2000e et seq..
Response: The relationship between the protections contained under
the federal health care provider conscience protection statutes and the
protections afforded under Title VII fall outside the scope of this
final rule. Under the final rule, the Department's Office for Civil
Rights (OCR) will continue to receive complaints alleging violations of
the federal health care provider conscience protection statutes. The
Equal Employment Opportunity Commission (EEOC) enforces Title VII,
which prohibits employers--including health care providers--from
discriminating against any applicant or employee in hiring, discipline,
promotion, termination, or other terms and conditions of employment
based on religious beliefs.
Guidance for handling complaints involving Title VII issues can be
found in Procedures for Complaints of Employment Discrimination Filed
Against Recipients of Federal Financial Assistance, 29 CFR part 1691
(Aug. 4, 1989). The Procedures provide for coordination between the
EEOC and other Federal departments for review, investigation, and
resolution of employment discrimination complaints, including those
based on religion.
Informed Consent
Comment: Many comments expressed concern that the 2008 Final Rule
would prevent a patient from being able to give informed consent,
because the health care provider might not advise the patient of all
health care options.
Response: The doctrine of informed consent requires that a health
care provider inform an individual patient of the risks and benefits of
any health care treatment or procedure. In order to give informed
consent, the patient must be able to understand and weigh the treatment
or procedure's risks and benefits, and must understand available
alternatives. Additionally, a patient must communicate his or her
informed consent to the provider, which is most commonly done through a
written document. State laws generally treat lack of informed consent
as a matter of negligence on the part of the health care provider
failing to disclose necessary information to the patient. Provider
association and accreditation association guidelines set forth
additional requirements on members and member entities.
We recognize that informed consent is crucial to the provision of
quality health care services. The provider-patient relationship is best
served by open communication of conscience issues surrounding the
provision of health care services. The Department emphasizes the
importance of and strongly encourages early, open, and respectful
communication between providers and patients surrounding sensitive
issues of health care, including the exercise of provider conscience
rights, and alternatives that are not being recommended as a result.
Partial rescission of the 2008 Final Rule should clarify any
mistaken belief that it altered the scope of information that must be
provided to a patient by their provider in order to fulfill informed
consent requirements.
D. Comments Addressing Whether the 2008 Final Rule Clarified the
Provider Conscience Statutes
Comment: The Department sought information regarding whether the
2008 Final Rule provided the clarity that it intended to provide. The
comments received in response to this question tended to focus on
whether or not the definitions contained in the 2008 Final Rule were
too broad. Commenters supporting rescission of the 2008 Final Rule
indicated that the definitions were far broader than the scope of the
federal provider conscience statutes. Commenters opposing rescission of
the 2008 Final Rule did not believe the definitions were too broad.
Many comments indicated that the 2008 Final Rule created confusion that
the federal provider conscience protections authorized refusal to treat
certain kinds of patients rather than to perform certain medical
procedures. Numerous comments on both sides questioned whether the 2008
Final Rule expanded the scope of the provider conscience statutes by
suggesting that the term ``abortion'' included contraception.
Response: The comments reflected a range of views regarding whether
the 2008 Final Rule added clarity to the federal health care conscience
statutes. The comments received illustrated that there is significant
division over whether the definitions provided by the 2008 Final Rule
are in line with the longstanding Federal health care provider
conscience protection statutes.
The Department agrees with concerns that the 2008 Final Rule may
have caused confusion as to whether the Federal statutory conscience
protections allow providers to refuse to treat entire groups of people
based on religious or moral beliefs. The Federal provider conscience
statutes were intended to protect health care providers from being
forced to participate in medical procedures that violated their moral
and religious beliefs. They were never intended to allow providers to
refuse to
[[Page 9974]]
provide medical care to an individual because the individual engaged in
behavior the health care provider found objectionable.
The 2008 Final Rule did not provide that the term ``abortion,'' as
contained in the Federal health care provider conscience protection
statutes, includes contraception. However, the comments reflect that
the 2008 Final Rule caused significant confusion as to whether abortion
also includes contraception. The provision of contraceptive services
has never been defined as abortion in federal statute. There is no
indication that the federal health care provider conscience statutes
intended that the term ``abortion'' included contraception.
The Department rescinds the definitions contained in the 2008 Final
Rule because of concerns that they may have caused confusion regarding
the scope of the federal health care provider conscience protection
statutes. The Department is not formulating new definitions because it
believes that individual investigations will provide the best means of
answering questions about the application of the statutes in particular
circumstances.
E. Comments Addressing Access to Health Care
Concerns the 2008 Final Rule Would Limit Access
Comment: The Department received several comments suggesting that
the 2008 Final Rule could limit access to reproductive health services
and information, including contraception, and could impact a wide range
of medical services, including care for sexual assault victims,
provision of HIV/AIDS treatment, and emergency services. Additionally,
a number of commenters expressed concern that the 2008 Final Rule could
disproportionately affect access to health care by certain sub-
populations, including low-income patients, minorities, the uninsured,
patients in rural areas, Medicaid beneficiaries, or other medically-
underserved populations.
Response: The Department agrees with comments that the 2008 Final
Rule may negatively affect the ability of patients to access care if
interpreted broadly. As noted above, in the litigation filed shortly
after issuance of the 2008 Final Rule, eight states sought to enjoin
implementation of the Rule, arguing that it would prevent them from
enforcing their state laws concerning access to contraception.
Connecticut v. United States, No. 3:09-CV-054-RNC (D. Conn).
Additionally, while there are no Federal laws compelling hospitals to
provide contraceptive services, the Medicaid Program does require that
States provide contraceptive services to Medicaid beneficiaries. The
Department is concerned that the breadth of the 2008 Final Rule may
undermine the ability of patients to access these services, especially
in areas where there are few health care providers for the patient to
choose from. As we state above, entities must continue to comply with
their Title X, Section 330, EMTALA, and Medicaid obligations, as well
as the federal health care provider conscience protection statutes.
Accordingly, the Department partially rescinds the 2008 Final Rule
based on concerns expressed that it had the potential to negatively
impact patient access to contraception and certain other medical
services without a basis in federal conscience protection statutes.
Concerns That Rescission of the 2008 Final Rule Would Limit Access
Comment: A substantial number of comments in opposition to
rescinding the 2008 Final Rule maintained that Roman Catholic hospitals
would have to close, that rescission of the rule would limit access to
pro-life counseling, and that providers would either leave the health
care industry or choose not to enter it, because they believed that
they would be forced to perform abortions. As such, these commenters
concluded that rescinding the 2008 Final Rule would limit access to
health care services or information.
Response: Under this partial rescission of the 2008 Final Rule,
Roman Catholic hospitals will still have the same statutory protections
afforded to them as have been for decades. The Department supports the
longstanding Federal health care provider conscience laws, and with
this Final Rule provides a clear process to enforce those laws. As
discussed above, the Federal health care provider conscience statutes
have provided protections for decades, and will continue to protect
health care providers after partial rescission of the 2008 Final Rule.
Entities must continue to comply with the Federal health care provider
conscience protection statutes. Moreover, under this Final Rule, health
care providers who believe their rights were violated will now be able
to file a complaint with the Department's Office for Civil Rights in
order to seek enforcement of those rights.
F. Comments Addressing Costs to Providers
Comment: The Department received several comments addressing the
costs to providers of the 2008 Final Rule. Commenters stated that the
new certification requirement imposed substantial additional
responsibilities on health care entities, and that the burden analysis
did not sufficiently account for the cost of collecting information
for, submitting, and maintaining the written certifications required by
the 2008 Final Rule. Additionally, the Department received several
comments outlining various estimates regarding the burdens, including
time and cost, on health care entities to comply with certification
requirements of the 2008 Final Rule.
Response: The Federal health care provider conscience protection
statutes mandating requirements for protecting health care providers
have been in effect for decades. The stated reason for enacting the
certification requirement was a concern that there is a lack of
knowledge on the part of states, local governments, and the health care
industry of the federal health care provider conscience protections.
The Department believes it can raise awareness of these protections by
amending existing grant documents to specifically require that grantees
acknowledge they must comply with the laws.
The Department estimated that 571,947 health care entities would be
required to comply with the certification requirements. The Department
also stated in the preamble to the 2008 Final Rule that it estimated
the total quantifiable costs of the regulation, including direct and
indirect costs, as $43.6 million each year. See 73 FR 98095, Dec. 18,
2009.
The Department agrees with these commenters, and believes that the
certification requirements in the 2008 Final Rule are unnecessary to
ensure compliance with the federal health care provider conscience
protection statutes, and that the certification requirements created
unnecessary additional financial and administrative burdens on health
care entities. The Department believes that amending existing grant
documents to require grantees to acknowledge that they will comply with
the provider conscience laws will accomplish the same result with far
less administrative burden. While proposed, the certification
requirements were never finalized under the previous rule, and they are
deleted in this rule. The Department emphasizes, however, that health
care entities remain responsible for costs associated with complying
with the Federal health care provider conscience protection statutes,
in the same way that health care entities were before the promulgation
of the 2008 Final Rule. Additionally, health care
[[Page 9975]]
providers can now seek enforcement of their conscience protections
through the Department's Office for Civil Rights.
V. Statutory Authority
The Secretary hereby rescinds, in part, redesignates, and revises
the 2008 Final Rule entitled ``Ensuring That Department of Health and
Human Services Funds Do Not Support Coercive or Discriminatory Policies
or Practices in Violation of Federal Law,'' in accordance with the
following statutory authority. As discussed above, the Federal health
care provider conscience protection statutes, including the Church
Amendments, the PHS Act Sec. 245, and the Weldon Amendment, require,
among other things, that the Department and recipients of Department
funds (including state and local governments) refrain from
discriminating against institutional and individual health care
entities for their participation in certain medical procedures or
services, including certain health services, or research activities
funded in whole or in part by the Federal government. However, none of
these statutory provisions require promulgation of regulations for
their interpretation or implementation. The provision of the 2008 Final
Rule establishing that the Office for Civil Rights is authorized to
receive and investigate complaints regarding violations of the federal
health care provider conscience statutes is being retained. This Final
Rule is being issued pursuant to the authority of 5 U.S.C. 301, which
empowers the head of an Executive department to prescribe regulations
``for the government of his department, the conduct of his employees,
the distribution and performance of its business, and the custody, use,
and preservation of its records, papers, and property.''
VI. Overview and Section-by-Section Description of the Final Rule
Section 88.1 describes the purpose of the Final Rule. The language
is revised slightly from the 2008 Final Rule, and states that the
purpose of Part 88 is to provide for the enforcement of the Church
Amendments, 42 U.S.C. 300a-7, section 245 of the Public Health Service
Act, 42 U.S.C. 238n, and the Weldon Amendment, Consolidated
Appropriations Act, 2010, Public Law 111-117, Div. D, Sec. 508(d), 123
Stat. 3034, 3279-80, referred to collectively as the ``federal health
care conscience protection statutes.''
Sections 88.2 through 88.5 of the 2008 Final Rule have been
removed. Section 88.2 contains definitions of terms used in the Federal
health care provider conscience statutes. Section 88.3 describes the
applicability of the 2008 Final Rule. Section 88.4 describes the
requirements and prohibitions under the 2008 Final Rule. Section 88.5
contains the certification requirement. The preamble to the August 26,
2008 Notice of Proposed Rulemaking (73 FR 50274) and the preamble to
the December 19, 2008 Final Rule (73 FR 78072) addressing these
sections are neither the position of the Department, nor guidance that
should be relied upon for purposes of interpreting the Federal health
care provider conscience protection statutes.
Section 88.6 has been re-designated as Section 88.2. Section 88.2
provides that the Department's Office for Civil Rights (OCR) is
designated to receive complaints of discrimination and coercion based
on the health care provider conscience protection statutes, and that
OCR will coordinate the handling of complaints with the HHS
Departmental funding component(s) from which the entity complained
about receives funding. This language is revised slightly from the 2008
Final Rule to clarify that ``Department funding component'' is not a
defined term.
VII. Impact Statement and Other Required Analyses
We have examined the impacts of this final rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993, as further amended), the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), section 202 of the Unfunded Mandates Reform Act of
1995 (2 U.S.C. 1532), Executive Order 13132 on Federalism (August 4,
1999), and the Congressional Review Act (5 U.S.C. 804(2)). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, if regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety effects,
distributive impacts, and equity). A regulatory impact analysis (RIA)
must be prepared for major rules with economically significant effects
($100 million or more in any one year). The 2008 Final Rule estimated
the quantifiable costs associated with the certification requirements
of the proposed regulation to be $43.6 million each year. Rescinding
the certification requirements of the final rule would therefore result
in a cost savings of $43.6 million each year to the health care
industry.
The RFA requires agencies to analyze options for regulatory relief
of small businesses if a rule has a significant impact on a substantial
number of small entities. With this final rule the Department is
rescinding the certification requirements which will reduce the
potential burden to small businesses. We have examined the implications
of this proposed rule as required by Executive Order 12866. Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 12866
classifies a rule as significant if it meets any one of a number of
specified conditions, including: having an annual effect on the economy
of $100 million, adversely affecting a single sector of the economy in
a material way, adversely affecting competition, or adversely affecting
jobs. This final rule is not economically significant under these
standards.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts State law, or otherwise has federalism
implications. This final rule would not require additional steps to
meet the requirements of Executive Order 13132.
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires cost-benefit and other analysis before any rulemaking if
the rule includes a ``Federal mandate that may result in the
expenditure by state, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year.'' The current inflation-adjusted
statutory threshold is approximately $130 million. We have determined
that this final rule does not create an unfunded mandate under the
Unfunded Mandates Reform Act, because it does not impose any new
requirements resulting in expenditures by state, local, and tribal
governments, or by the private sector.
Section 654 of the Treasury and General Government Appropriations
Act of 1999 requires Federal departments and agencies to determine
whether a proposed policy or regulation could affect family well-being.
If the determination is affirmative, then the Department or agency must
prepare an impact assessment to address criteria specified in the law.
This final rule will not have an impact on family wellbeing,
[[Page 9976]]
as defined in the Act, because it affects only regulated entities and
eliminates costs that would otherwise be imposed on those entities.
VIII. Paperwork Reduction Act Information Collection
This final rule eliminates requirements that would be imposed by
the 2008 Final Rule. The 60-day comment period on the information
collection requirements of the 2008 Final Rule expired on February 27,
2009, and OMB approval for the information collection requirements will
not be sought.
New Paperwork Collection Act Information for Complaints
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and to solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. To
fairly evaluate whether an information collection should be approved by
OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995
requires that we solicit comment on the following issues:
1. The need for the information collection and its usefulness in
carrying out the proper functions of our agency.
2. The accuracy of our estimate of the information collection
burden.
3. The quality, utility, and clarity of the information to be
collected.
4. Recommendations to minimize the information collection burden on
the affected public, including automated collection techniques.
Under the PRA, the time, effort, and financial resources necessary
to meet the information collection requirements referenced in this
section are to be considered. We explicitly seek, and will consider,
public comment on our assumptions as they relate to the PRA
requirements summarized in this section. To comment on this collection
of information or to obtain copies of the supporting statement and any
related forms for the proposed paperwork collections referenced above,
e-mail your comment or request, including your address and phone number
to [email protected], or call the Reports Clearance Office
on (202) 690-6162. Written comments and recommendations for the
proposed information collections must be directed to the OS Paperwork
Clearance Officer at the above e-mail address within 60 days.
45 CFR part 88, Sec. 88.2 provides that individuals or entities
may file written complaints with the Department's Office for Civil
Rights if they believe they have been discriminated against under the
federal health care provider conscience protection statutes by programs
or entities that receive Federal financial assistance from the
Department. The new information collection provisions associated with
this final rule will not go into effect until approved by OMB. HHS will
separately post a notice in the Federal Register at that time.
The table below reflects the Office for Civil Rights current
complaint receipts under its other civil rights enforcement
authorities. HHS does not expect the burden to increase measurably as a
result of this provision.
Estimated Annualized Burden Table
Individuals may file written complaints with the Office for Civil
Rights when they believe they have been discriminated against on the
basis of race, color, national origin, age, disability, and, in certain
circumstances, sex and religion by programs or entities that receive
Federal financial assistance from the Department of Health and Human
Services. The table below includes: The annual number of respondents to
the Office for Civil Rights regarding all the authorities that it
enforces; the frequency of submission, including recordkeeping and
reporting on occasion; and the affected public, including not-for-
profit entities and individuals.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Forms (if necessary) Type of respondent Number of responses per hours per Total burden
respondents respondent response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Civil Rights Complaint Form.................. Individuals or Not-for-profit entities... 3037 1 45/60 2278
----------------------------------------------------------------------------------------------------------
Total.................................... ......................................... 3037 .............. .............. 2278
--------------------------------------------------------------------------------------------------------------------------------------------------------
List of Subjects in 45 CFR Part 88
Abortion, Civil rights, Colleges and universities, Employment,
Government contracts, Government employees, Grant programs, Grants
administration, Health care, Health insurance, Health professions,
Hospitals, Insurance companies, Laboratories, Medicaid, Medical and
dental schools, Medical research, Medicare, Mental health programs,
Nursing homes, Public health, Religious discrimination, Religious
liberties, Reporting and recordkeeping requirements, Rights of
conscience, Scientists, State and local governments, Sterilization,
Students.
Dated: February 17, 2011.
Kathleen Sebelius,
Secretary.
For the reasons set forth in the preamble, the Department amends 45
CFR part 88, as set forth below:
PART 88--ENSURING THAT DEPARTMENT OF HEALTH AND HUMAN SERVICES
FUNDS DO NOT SUPPORT COERCIVE OR DISCIMINATORY POLICIES OR
PRACTICES IN VIOLATION OF FEDERAL LAW
0
1. The authority citation for part 88 is revised to read as follows:
Authority: 5 U.S.C. 301.
0
2. The heading of part 88 is revised to read as set forth above.
0
3. Revise Sec. 88.1 to read as follows:
Sec. 88.1 Purpose.
The purpose of this part is to provide for the enforcement of the
Church Amendments, 42 U.S.C. 300a-7, section 245 of the Public Health
Service Act, 42 U.S.C. 238n, and the Weldon Amendment, Consolidated
Appropriations Act, 2010, Public Law 111-117, Div. D, Sec. 508(d), 123
Stat. 3034, 3279-80, referred to collectively as the ``federal health
care provider conscience protection statutes.''
0
4. Remove Sec. Sec. 88.2 through 88.5.
0
5. Redesignate Sec. 88.6 as Sec. 88.2.
0
6. Revise newly designated Sec. 88.2 to read as follows:
Sec. 88.2 Complaint handling and investigating.
The Office for Civil Rights (OCR) of the Department of Health and
Human Services is designated to receive complaints based on the Federal
health care provider conscience protection statutes. OCR will
coordinate the handling of complaints with the Departmental funding
component(s) from which the entity, to which a
[[Page 9977]]
complaint has been filed, receives funding.
[FR Doc. 2011-3993 Filed 2-18-11; 11:15 am]
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