[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

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    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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