[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Rules and Regulations]
[Pages 78071-78101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30134]



[[Page 78071]]

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Part VI





Department of Health and Human Services





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45 CFR Part 88



Ensuring That Department of Health and Human Services Funds Do Not 
Support Coercive or Discriminatory Policies or Practices in Violation 
of Federal Law; Final Rule

Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / 
Rules and Regulations

[[Page 78072]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 88

RIN 0991-AB48


Ensuring That Department of Health and Human Services Funds Do 
Not Support Coercive or Discriminatory Policies or Practices in 
Violation of Federal Law

AGENCY: Office of the Secretary, HHS.

ACTION: Final rule.

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SUMMARY: The Department of Health and Human Services (HHS) is issuing a 
final rule to ensure that Department funds do not support morally 
coercive or discriminatory practices or policies in violation of 
federal law, pursuant to the Church Amendments (42 U.S.C. 300a-7), 
Public Health Service (PHS) Act Sec.  245 (42 U.S.C. 238n), and the 
Weldon Amendment (Consolidated Appropriations Act, 2008, Public Law 
110-161, Div. G, Sec.  508(d), 121 Stat. 1844, 2209). This final rule 
defines certain key terms. In order to ensure that recipients of 
Department funds know about their legal obligations under these federal 
health care conscience protection laws, the Department is requiring 
written certification by certain recipients that they will comply with 
all three statutes, as applicable. Finally, this final rule assigns 
responsibility for complaint handling and investigation among the 
Department's Office for Civil Rights and Department program offices.

DATES: This rule is effective January 20, 2009.

FOR FURTHER INFORMATION CONTACT: For further information regarding this 
rule, contact: Brenda Destro, (202) 401-2305, Office of Public Health 
and Science, Department of Health and Human Services, Room 728E, Hubert 
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 
20201. For information regarding how to file a complaint with the 
Office for Civil Rights, U.S. Department of Health and Human Services, 
contact: Vernell Lancaster, (202) 260-7180, Office for Civil Rights, 
Department of Health and Human Services, Room 533F, Hubert H. Humphrey 
Building, 200 Independence Avenue, SW., Washington, DC 20201.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Introduction
II. Comments on the Proposed Rule
    A. Comments on Proposed New Sec.  88.1--Purpose
    B. Comments on Proposed New Sec.  88.2--Definitions
    C. Comments on Proposed New Sec.  88.3--Applicability
    D. Comments on Proposed New Sec.  88.4--Requirements and 
Prohibitions
    E. Comments on Proposed New Sec.  88.5--Written Certification of 
Compliance
    F. Comments Received in Response to Specific Requests for 
Comments in the Proposed Rule
    G. General Comments
III. Legal Authority
IV. Section-by-Section Description of the Final Rule
V. Analysis of Economic Impacts
VI. Paperwork Reduction Act of 1995

I. Introduction

Statutory Background

    Several provisions of federal law prohibit recipients of certain 
federal funds from coercing individuals in the health care field into 
participating in actions they find religiously or morally 
objectionable. These same provisions also prohibit discrimination on 
the basis of one's objection to, participation in, or refusal to 
participate in, specific medical procedures, including abortion or 
sterilization. In addition, there is a statutory provision that 
prohibits the federal government and State and local governments from 
discriminating against individual and institutional providers who 
refuse, among other things, to receive training in abortions, require 
or provide such training, perform abortions, or refer for or make 
arrangements for abortions or training in abortions. More recently, an 
appropriations provision has been enacted (and reenacted or 
incorporated into every appropriations act since the appropriations act 
for Fiscal Year 2005) that prohibits certain federal agencies and 
programs and State and local governments that receive certain federal 
funds from discriminating against individuals and institutions that 
refuse to, among other things, provide, refer for, pay for, or cover, 
abortion. These statutes are collectively referred to as the ``federal 
health care conscience protection statutes.'' This rule is intended to 
ensure that, in the delivery of health care and other health services, 
recipients of Department funds do not support coercive or 
discriminatory practices in violation of these laws.

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 in Response to debates over whether 
receipt of federal funds required the recipients of such funds to 
perform abortions or sterilizations. The first conscience provision in 
the Church Amendments, 42 U.S.C. 300a-7(b), provides that ``[t]he 
receipt of any grant, contract, loan, or loan guarantee under [certain 
statutes implemented by the Department of Health and Human Services] * 
* * by any individual or entity does not authorize any court or any 
public official or other public authority to require'': (1) The 
individual to perform or assist in a sterilization procedure or an 
abortion, if it would be contrary to his/her religious beliefs or moral 
convictions; (2) the entity to make its facilities available for 
sterilization procedures or abortions, if the performance of 
sterilization procedures or abortions in the facilities is prohibited 
by the entity on the basis of religious beliefs or moral convictions; 
or (3) the entity to provide personnel for the performance of 
sterilization procedures or abortions, if it would be contrary to the 
religious beliefs or moral convictions of such personnel.
    The second conscience provision in the Church Amendments, 42 U.S.C. 
300a-7(c)(1), prohibits any entity which receives a grant, contract, 
loan, or loan guarantee under certain Department-implemented statutes 
from discriminating against any physician or other health care 
personnel in employment, promotion, termination of employment, or the 
extension of staff or other privileges because the individual either 
``performed or assisted in the performance of a lawful sterilization 
procedure or abortion, or because he refused to perform or assist in 
the performance of such a procedure or abortion on the grounds that his 
performance or assistance in the performance of the procedure or 
abortion would be contrary to his religious beliefs or moral 
convictions, or because of his religious beliefs or moral convictions 
respecting sterilization procedures or abortions.''
    The third conscience provision, contained in 42 U.S.C. 300a-
7(c)(2), prohibits any entity which receives a grant or contract for 
biomedical or behavioral research under any program administered by the 
Department from discriminating against any physician or other health 
care personnel in employment, promotion, termination of employment, or 
extension of staff or other privileges ``because he performed or 
assisted in the performance of any lawful health service or research 
activity, or because he refused to perform or assist in the performance 
of any such service or activity on the grounds that his performance of 
such service or activity would be contrary to his religious beliefs or 
moral convictions, or because of his religious beliefs or moral 
convictions respecting any such service or activity.''

[[Page 78073]]

    The fourth conscience provision, 42 U.S.C. 300a-7(d), provides that 
``[n]o individual shall be required to perform or assist in the 
performance of any part of a health service program or research 
activity funded in whole or in part under a program administered by 
[the Department] if his performance or assistance in the performance of 
such part of such program or activity would be contrary to his 
religious beliefs or moral convictions.''
    The final conscience provision contained in the Church Amendments, 
42 U.S.C. 300a-7(e), prohibits any entity that receives a grant, 
contract, loan, or loan guarantee under certain Departmentally 
implemented statutes from denying admission to, or otherwise 
discriminating against, ``any applicant (including 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 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 receive 
training in the performance of abortions, to require or provide such 
training, to perform such abortions, or to provide referrals for such 
training or such abortions; (2) refuses to make arrangements for such 
activities; or (3) attends or attended a post-graduate physician 
training program or any other training program in the health 
professions that does not (or did not) perform abortions or require, 
provide, or refer for training in the performance of abortions or make 
arrangements for the provision of such training. For the purposes of 
this protection, the statute defines ``financial assistance'' as 
including, ``with respect to a government program,'' ``governmental 
payments provided as reimbursement for carrying out health-related 
activities.'' In addition, PHS Act 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 (such as a medical license)), the federal government and 
any State or local government receiving federal financial assistance 
deem accredited any post-graduate physician training program that would 
be accredited, but for the reliance on an accrediting standard that, 
regardless of whether such standard provides exceptions or exemptions, 
requires an entity: (1) To perform induced abortions; or (2) to 
require, provide, or refer for training in the performance of induced 
abortions, or make arrangements for such training.

Weldon Amendment [Consolidated Appropriations Act, 2008, Public Law 
110-161, Div. G, Sec.  508(d), 121 Stat. 1844, 2209 (Dec. 26, 2007)]

    The Weldon Amendment, originally adopted as section 508(d) of the 
Labor-HHS Division (Division F) of the 2005 Consolidated Appropriations 
Act, Public Law 108-447 (Dec. 8, 2004), has been readopted (or 
incorporated by reference) in each subsequent HHS appropriations act. 
Title V of the Departments of Labor, Health and Human Services, and 
Education, and Related Agencies Appropriations Act, 2006, Public Law 
109-149, Sec.  508(d), 119 Stat. 2833, 2879-80; Revised Continuing 
Appropriations Resolution of 2007, Public Law 110-5, Sec.  2, 121 Stat. 
8, 9; Consolidated Appropriations Act, 2008, Public Law 110-161, Div. 
G, Sec.  508(d), 121 Stat. 1844, 2209; Consolidated Security, Disaster 
Assistance, and Continuing Appropriations Act, 2009, Public Law 110-
329, Div. A, Sec.  101, 122 Stat. 3574, 3575. The Weldon Amendment 
provides that ``[n]one of the funds made available under this Act 
[making appropriations for the Departments of Labor, Health and Human 
Services, and Education] may be made available to a federal agency or 
program, or to a State or local government, if such agency, program, or 
government subjects any institutional or individual health care entity 
to discrimination on the basis that the health care entity does not 
provide, pay for, provide coverage of, or refer for abortions.'' It 
also defines ``health care entity'' to include ``an individual 
physician or other health care professional, a hospital, a provider-
sponsored organization, a health maintenance organization, a health 
insurance plan, or any other kind of health care facility, 
organization, or plan.''

The Proposed Rule

    On August 26, 2008 (73 FR 50274), the Office of the Secretary, 
Department of Health and Human Services, published a Notice of Proposed 
Rulemaking (proposed rule) entitled, ``Ensuring That Department of 
Health and Human Services Funds Do Not Support Coercive or 
Discriminatory Policies or Practices In Violation of Federal Law.'' The 
proposed rule set forth the purpose of the proposed rule, proposed 
definitions to clarify the meaning of statutory requirements, and 
proposed to require certain recipients and sub-recipients of 
Departmental funds to certify their compliance with the statutory 
requirements.
    The Comment: period closed on September 25, 2008.

The Final Rule

    As noted in the preamble to the proposed rule, the Department is 
concerned about the development of an environment in sectors of the 
health care field that is intolerant of individual objections to 
abortion or other individual religious beliefs or moral convictions. 
Such developments may discourage individuals from entering health care 
professions. Such developments also promote the mistaken belief that 
rights of conscience and self-determination extend to all persons, 
except health care providers. Additionally, religious and faith-based 
organizations have a long tradition of providing medical care in the 
United States, and they continue to do so today--some of these are 
among the largest providers of health care in this nation. Such 
institutions may have traditions of issuing clear public guidance which 
informs the members of their workforces, including physicians having 
privileges at their institutions, of the parameters under which they 
should operate in accordance with the organization's overall mission 
and ethics. A trend that isolates and excludes some among various 
religious, cultural, and/or ethnic groups from participating in the 
delivery of health care is especially troublesome when considering 
current and anticipated shortages of health care professionals in many 
medical disciplines and regions of the country.
    The Department is committed to its mission of expanding patient 
access to necessary health care services. Americans can enjoy 
healthier, happier, and more productive lives through access to, and 
appropriate utilization of, all of the life-saving and life-improving 
procedures and services produced by medical innovation. The Department 
has a long history of demonstrated success in facilitating the 
improvement of lives in this way.
    A necessary element in ensuring the best possible care for patients 
is protecting the integrity of the doctor-patient relationship. 
Patients need full access to their health care provider's best judgment 
as informed by practice, knowledge, and experience. This

[[Page 78074]]

relationship requires open communication between both parties so 
patients can be confident that the care they seek and receive is 
endorsed by their health care provider. It is one of the reasons for 
the common practice of patients meeting with several health care 
providers in order to find the one in whom they are most confident 
about entrusting their care. This helps ensure patients receive the 
care they believe is appropriate, and that doctors provide care that 
they are comfortable providing.
    The doctor-patient relationship requires a balancing of interests. 
The patient has an interest in obtaining legal health care services--
and, in the context of federally funded health care programs, an 
eligible patient may have the right to obtain certain health care 
services from certain entities. This must be balanced against the 
statutory right of the provider in the context of a federally funded 
entity to not be discriminated against based on a refusal to 
participate in a service to which they have objections, such as 
abortion. As stated above, Congress recognized those provider rights in 
several statutes.
    The Department seeks to ensure this balance through raising 
awareness of federal health care conscience protection laws by 
specifically including reference to the nondiscrimination provisions 
contained in the Church Amendments, PHS Act Sec.  245, and the Weldon 
Amendment in certifications currently required of most existing and 
potential recipients of Department funds. It also seeks to provide for 
Departmental enforcement of these three statutes.
    Toward these ends, the Department has concluded that regulations 
and related efforts are necessary, in order to (1) educate the public 
and health care providers on the obligations imposed, and protections 
afforded, by federal law; (2) work with State and local governments and 
other recipients of funds from the Department to ensure compliance with 
the nondiscrimination requirements embodied in the Church Amendments, 
PHS Act Sec.  245, and the Weldon Amendment; (3) when such compliance 
efforts prove unsuccessful, enforce these health care conscience 
protection laws through the various Department mechanisms currently in 
existence, to ensure that Department funds do not support morally 
coercive or discriminatory practices or policies in violation of 
federal law; and (4) otherwise take an active role in promoting open 
communication within the health care field, and between providers and 
patients, fostering a more inclusive, tolerant environment in the 
health care industry than may currently exist.
    The ability of patients to access health care services, including 
abortion and reproductive health services, is long-established and is 
not changed in this rule. Instead, this rule implements federal laws 
protecting health care workers and institutions from being compelled to 
participate in, or from being discriminated against for refusal to 
participate in, health services or research activities that may violate 
their consciences, including abortion and sterilization, by entities 
that receive certain funding from the Department. (It also implements 
the provisions of federal law which protect health care personnel from 
being discriminated against for their participation in any lawful 
health service or research activity, including abortion and 
sterilization, by entities that receive certain funding from the 
Department.) Delivery of health care services is significantly improved 
when patients and health care providers have full, open, and honest 
conversations about the services they request and provide. These 
conversations are particularly useful at the beginning of a patient-
provider relationship. This rule should help generate greater 
transparency between patients and providers and foster open discussion, 
which should strengthen relationships between patients and providers, 
as well as those between entities and their employees.
    This final rule sets out, and provides further definition of, the 
rights and responsibilities created by the federal health care provider 
conscience provisions. It clarifies the scope of protections to 
applicable members of the Department's workforce, as well as health 
care entities and members of the workforces of entities receiving 
Department funds. This final rule also requires certain recipients and 
sub-recipients of Department funds to certify compliance with these 
federal requirements. In order to ensure proper enforcement, this final 
rule defines certain terms for the purposes of this final rule.
    As was stated in the preamble to the proposed rule, the Office for 
Civil Rights (OCR) of the Department of Health and Human Services has 
been designated to receive complaints of discrimination and coercion 
based on the healthcare conscience protection statutes and this 
regulation. OCR will coordinate handling of complaints with the staff 
of the Departmental programs from which the entity, with respect to 
whom a complaint has been filed, receives funding (i.e., Department 
funding component). Enforcement of the requirements set forth in this 
regulation will be conducted by staff of the Department funding 
component through the usual and ordinary program mechanisms. Compliance 
with the requirements promulgated herein will likely be examined as 
part of any broader compliance review conducted by Department staff. If 
the Department becomes aware that a State or local government or an 
entity may have undertaken activities that could lead to violation of, 
or may actually be in violation of, the requirements or prohibitions 
promulgated herein, the Department will work with such government or 
entity to assist such government or entity to comply or come into 
compliance with such requirements or prohibitions. If, despite the 
Department's assistance, compliance is not achieved, the Department 
will consider all legal options, including termination of funding, 
return of funds paid out in violation of health care conscience 
protection provisions under 45 CFR parts 74, 92, and 96, as applicable.

II. Comments on the Proposed Rule

    On August 26, 2008 (73 FR 50274), Department of Health and Human 
Services published the proposed rule. The Department received a large 
volume of Comments on the proposed rule, both from Commenters 
supporting the proposed rule, as well as from those opposing the 
proposed rule. Comments came from a wide variety of individuals and 
organizations, including private citizens, individual and institutional 
health care providers, religious organizations, patient advocacy 
groups, professional organizations, universities and research 
institutions, consumer organizations, and State and federal agencies 
and representatives. Comments dealt with a range of issues surrounding 
the proposed rule, including the need for the rule; what kinds of 
workers would be protected by the proposed rule; what services are 
covered by the proposed rule; whether health care workers use the 
regulation to discriminate against patients; what significant 
implementation issues could be associated with the rule; legal 
arguments; and the cost impacts of the proposed rule. Many Comments 
from health care providers, members of the public, and others confirmed 
the need to promulgate this regulation to raise awareness of federal 
conscience protections and provide for their enforcement.
    A summary of the substantive Comments, and the Department's 
Responses to those Comments, follows.

[[Page 78075]]

A. Comments on Proposed New Sec.  88.1--Purpose

    No Comments were received pertaining to this section.

B. Comments on Proposed New Sec.  88.2--Definitions

Assist in the Performance
    Comment: Many Comments suggested that the proposed definition of 
``assist in the performance'' was too broad. These Comments focused 
primarily on the inclusion of referral, training, and other 
arrangements within the ambit of this statutory term, claiming that 
this would allow an individual or institution to refuse to provide 
information or counseling about an objectionable procedure to which he 
or it objected. Commenters also expressed concern that the definition 
was too broad because, they asserted, a health care provider has an 
obligation to provide or assist patients with a referral or other 
information that allows the patient to receive health care services, 
regardless of the health care provider's conscientious objection.
    Response: Commenters raising these concerns may lack understanding 
of the context in which the term ``assist in the performance'' is used 
in the statutes and in this regulation. The term is only used in the 
Church Amendments and in the provisions of this regulation that 
implement those statutory provisions. As noted above (see section I), 
all provisions of the Church Amendment use the term ``assist in the 
performance'' to ensure that individuals are protected from being 
required to assist in the performance of certain health care services 
or research activities, and from being discriminated against on the 
basis that the individual (1) assisted in the performance of a legal 
health service or research activity, or (2) refused to assist in the 
performance of such a health service or research activity because it 
would be contrary to his religious beliefs or moral conviction. Given 
that context, in interpreting the term ``assist in the performance,'' 
the Department has sought to provide broad protection for individuals, 
consistent with the plain language of the statutes. As a policy matter, 
the Department believes that limiting the definition of the statutory 
term ``assist in the performance'' only to those activities that 
constitute direct involvement with a procedure, health service, or 
research activity, falls short of implementing the protections Congress 
intended under federal law. However, we recognized the potential for 
abuse if the term was unlimited. Accordingly, we proposed--and here 
finalize--a definition of ``assist in the performance'' that is limited 
to ``any activity with a reasonable connection to a procedure, health 
service or health service program, or research activity.'' We also 
finalize the limitation in the definition that required the individual 
involved to be ``a part of the workforce of a Department-funded 
entity.''
    We wish to clarify here the scope of federal law respecting the 
protections afforded with respect to ``assist[ing] in the performance'' 
of a procedure, health service, or research activity. Whether the 
relevant provision of the Church Amendments uses the term 
``individual'' (42 U.S.C. 300a-7(b)(1), (d)), ``personnel'' (42 U.S.C. 
300a-7(b)(2)(B)), ``any physician or other health care personnel'' (42 
U.S.C. 300a-7(c)(1)-(2)), or applicant [ ] for training or study'' (42 
U.S.C. 300a-7(e)), the term ``assist in the performance'' of a 
procedure, health service, or research activity applies to people. 
Thus, the protections of the Church Amendments with respect to 
``assist[ing] in the performance'' of a procedure, health service, or 
research activity are afforded only with respect to people. To the 
extent such entities' or institutions' refusal to assist in the 
performance of such an activity would not be protected by PHS Act Sec.  
245, the Weldon Amendment, or the Church Amendments at section 300a-
7(b)(2), such entities or institutions would have to arrange to provide 
any information or service otherwise required by law.
Individual and Workforce
    Comment: Some Comments questioned whether the proposed definitions 
of the terms ``individual'' and ``workforce'' are too broad. Comments 
suggested that the definitions of these two terms would require a 
health care facility to apply the protections to all of its employees 
and contractors, no matter how removed their involvement is from the 
delivery of abortion or sterilization services. Other Comments 
expressed concern that the proposed definition of ``workforce'' would 
extend the conscience protections to volunteers and trainees. 
Commenters were also concerned that physicians, hospitals, and other 
health care institutions may find the definition burdensome in various 
areas of their operation (e.g., janitorial services, medical 
recordkeeping, security, reception services). Lastly, Comments asserted 
that the definition of ``workforce'' needs to be changed to provide a 
complete list of the types of individuals who fall within it.
    Response: The Department believes that its proposed definition of 
``individual'' is consistent with the statutory language and the intent 
of Congress as gleaned from an examination of the provisions in 
context. We had proposed to define ``individual'' as ``a member of the 
workforce of an entity/health care entity.''
    As noted above, the term ``individual'' is used in two provisions 
of the Church Amendments: 42 U.S.C. 300a-7(b)(1) \1\ and 42 U.S.C. 
300a-7(d).\2\ In other provisions of the Church Amendments, Congress 
chose to use more clearly limiting terms: ``personnel'' (42 U.S.C. 
300a-7(b)(2)(B)), ``any physician or other health care personnel'' (42 
U.S.C. 300a-7(c)(1)&(2)), or ``applicant [] for training or study'' (42 
U.S.C. 300a-7(e)). In addition, those other provisions are explicitly 
limited to discrimination in the employment/privileging or education/
training contexts, while 42 U.S.C. 300a-7(d) is not so limited: It 
provides that ``[n]o individual shall be required to perform or assist 
in the performance of any part of a health service program or research 
activity funded in whole or in part under a program administered by 
[HHS]'' if doing so ``would be contrary to his religious beliefs or 
moral convictions.'' Given this context, we believe that Congress did 
not intend that the term ``individual'' be limited to employees or 
health care personnel with privileges at a Department-funded entity, 
and that it is reasonable to include volunteers and trainees in the 
definition of ``workforce.'' These laws are intended to protect the 
conscience rights of all individuals participating in health care 
services, and research programs and activities receiving certain 
federal funds, or that are administered by the Department. The 
Department provides a definition of the term ``workforce'' to serve as 
a limiting criterion to ensure that individuals that are not under the 
control of an entity receiving Department funds do not claim the 
protection afforded by the statues. We further note that, where the 
individual is assisting in the performance of a sterilization procedure 
or abortion (or

[[Page 78076]]

any other health service or research activity) in which the provisions 
of the Church Amendments are relevant, the definition of ``assist in 
the performance'' further limits the protection to ``any activity with 
a reasonable connection to a procedure, health service or health 
program, or research activity * * *.'' Thus, we disagree with the 
Comment that the definitions would require a health care facility to 
apply protections to all of its employees and contractors no matter how 
far removed from the performance of sterilization procedures or 
abortion. The Department acknowledges that these definitions would 
include volunteers and trainees. It is clear that the statutes 
specifically envision that these protections apply to training 
programs, students, and applicants for training or study in the health 
professions. Regarding the Comment that physicians, hospitals or other 
providers may find it difficult or burdensome to comply with this 
requirement, the Department points to the fact that these requirements 
are not new, but are rather existing conditions on certain federal 
funds that recipients should be following already.
---------------------------------------------------------------------------

    \1\ 42 U.S.C. 300a-7(b)(1) provides that the ``[t]he receipt of 
any grant, contract, loan, or loan guarantee under [certain statutes 
implemented by HHS] * * * by any individual * * * does not authorize 
any court or any public official or other public authority to 
require'' the individual to perform or assist in a sterilization 
procedure or an abortion if it would be contrary to his/her 
religious beliefs or moral convictions.
    \2\ 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 [HHS]'' if doing so ``would be 
contrary to his religious beliefs or moral convictions.''
---------------------------------------------------------------------------

    The Department agrees with the Comment that the term ``workforce'' 
should provide a complete identification of covered individuals, and 
will therefore replace the word ``includes'' with the word ``means'', 
to provide a clearer and more definitive definition.
    As indicated in the proposed rule--and consistent with the scope of 
the Church Amendments, which include physicians and other health care 
providers that have privileges with an entity receiving funding from 
the Department--we intended the concept of ``workforce'' to include 
physicians and other health care providers who have privileges at the 
entity funded by the Department. After publication of the proposed 
rule, it came to the Department's attention that the language of the 
``workforce'' definition may not be clear on this issue. Accordingly, 
to ensure clarity on this point, we are revising the definition of 
``workforce'' by adding at the end ``or health care providers holding 
privileges with the entity.'' The definition now reads: `` `workforce' 
means employees, volunteers, trainees, contractors, and other persons 
whose conduct, in the performance of work for a Department-funded 
entity, is under the control or authority of such entity, whether or 
not they are paid by the Department-funded entity, or health care 
providers holding privileges with the entity.
Health Care Entity/Entity
    Comment: A number of Comments suggested that the definitions of 
``health care entity'' and ``entity'' are too broad and go beyond those 
in the Public Health Service Act and the Weldon Amendment. They assert 
that the Department exceeded its rule-making authority when it applied 
the legal standard enunciated in the Weldon Amendment and Public Health 
Service Act to ``health care entities'' that are not encompassed by the 
definitions set forth in those statutes. Comments also requested that 
the Department clarify whether a health care entity includes 
pharmacists, nurses, occupational therapists, public-health workers, 
janitors working for health care entities, and technicians, as well as 
psychiatrists, psychologists, counselors, and other mental health 
workers, while others suggested that pharmacists should not be 
included. Lastly, one Commenter expressed concern that the proposed 
rule did not specify what amount of Departmental funding would place an 
entity under the purview of these regulations.
    Response: The Department believes the definitions proposed in the 
proposed rule and adopted herein are appropriate and within its 
authority. In providing definitions of the term ``health care entity'' 
in their statutes, the Weldon Amendment and Public Health Services Act 
use the word ``include.'' As a matter of statutory drafting and 
construction, the use of that word indicates that the list following it 
is not exhaustive. In seeking to issue this regulation, the Department 
thought it would be beneficial to provide a clear and consistent 
definition that it would apply when implementing any of the three 
statutes. In proposing the definition, the Department intended it to be 
appropriately broad, but did not attempt to specifically list every 
possible entity or health profession classification, to avoid the 
situation that new health care professional classifications--or current 
health care professions inadvertently not listed--were not protected. 
As such, the Department used the terms ``health care professional'' and 
``health care personnel'' to cover other professions such as 
pharmacists, nurses, occupational therapists, public-health workers, 
and technicians, as well as psychiatrists, psychologists, counselors, 
and other mental health workers. The Department rejects the suggestion 
that pharmacists or pharmacies be specifically excluded from the 
definition because that would seem inconsistent with both the text and 
the purpose of the statutes. Lastly, the Department is concerned that 
some Commenters may incorrectly believe that there is a minimum 
financial threshold below which entities may receive a certain amount 
of Departmental funds without being subject to he statutory provisions 
and these implementing regulations. As in other cases, such as Title VI 
of the Civil Rights Act of 1964, when an entity elects to receive any 
amount of federal funds, that entity agrees to follow all conditions 
and rules that apply to the use of those funds or upon which receipt of 
the funds is conditioned.
Health Service/Health Service Program
    Comment: Several Comments declared that the definitions of ``health 
service'' and ``health service program'' inappropriately expand the 
scope of the conscience provisions to all medical treatments or 
services, biomedical and behavioral research, activities related to 
providing medicine, health care, or other services related to health or 
wellness (including programs such as Medicare and Medicaid). Some 
observed that the definitions include certain public health programs, 
such as vaccinations and family planning. Lastly, other Comments on 
these proposed definitions suggested that the definition of ``health 
service program'' be expanded to specifically include assisted suicide, 
transgender-related surgery and assisted reproductive technologies.
    Response: Commenters' objections to this definition are 
fundamentally an objection to the Department's interpretation of the 
scope of the statutory protections themselves. We proposed to define 
``health service program'' as including any plan or program that 
provides health benefits, whether directly, through insurance, or 
otherwise, which is funded, in whole or in part, by the Department, 
which may include components of programs operated by State or local 
governments. There is nothing in the statute to suggest that the term 
``health service program'' in 42 U.S.C. 300a-7(d) is to be read 
narrowly. Moreover, given the context of the provision in which it 
appears, while individuals and health care personnel are protected with 
respect to their participation in research activities, it would not be 
the result of a broad understanding of ``health service,'' but because 
such individuals and healthcare personnel are engaged in performing or 
assisting in the performance of research activities funded under 
programs administered by the Department, which are subject to statutory 
protection. See 42 U.S.C. 300a-7(d). The definition and

[[Page 78077]]

the statutory protections apply to health services and research 
activities that are funded in whole or in part by the Department. For 
the Department to adopt a definition that removes protection from 
entire programs that are appropriately included in the definition, 
given the statutory context, would be inconsistent with our 
understanding of the purpose of the statutory provisions. The 
observation that some of these programs may involve important public 
health issues that may be controversial or objectionable to some is not 
a justification to eliminate the statutory protections. The Comment 
that seeks the inclusion of ``assisted suicide'' and other procedures 
in the definition of ``health service program'' is misinformed. This 
definition does not set out a list or description of the types of 
procedures to which a protected individual may or may not object, but 
the types of programs under which such protection exists.
    While the Department had proposed to define the term ``health 
service,'' the Department has determined that the term is self-
explanatory, and that a definition is not necessary, or may potentially 
confuse recipients. Accordingly, we do not finalize a definition of the 
term.
Recipient/Sub-Recipient
    Comment: Several Comments expressed concern over extending the 
applicability of the proposed definitions of ``recipient'' and ``sub-
recipient'' to foreign non-governmental organizations or international 
organizations (such as agencies of the United Nations) without 
reference to existing federal law governing U.S. foreign policy. These 
Comments claimed that it could create confusion among federal agencies 
about which laws to follow and could lead to unforeseen foreign policy 
complications. They added that it may also create confusion for 
entities that receive United States funding, but are located outside of 
the United States.
    Response: The Department does not believe a conflict exists between 
these statutory requirements and U.S. foreign policy related to the use 
of federal funds abroad. To reduce any potential confusion among 
federal agencies, we proposed and here finalize a definitions of 
recipient and sub-recipient which permit the Department awarding agency 
to exercise discretion as to whether the terms include foreign or 
international organizations (such as agencies of the United Nations).
Other Definitions
    Comment: Many Commenters asserted the term ``abortion'' should be 
defined in the regulation, some believing that, without such 
definition, the proposed rule does not provide sufficient information 
to direct health care providers to meet the obligations of the 
requirements. The main division among Commenters regarding the 
definition of abortion was whether certain contraceptive methods or 
services that have the potential to terminate a fertilized egg after 
conception but before implantation are considered abortion under the 
proposed rule. Several Commenters claimed that the proposed rule would 
seriously jeopardize Title X programs and Medicaid services if 
``abortion'' is not clearly defined to exclude contraceptive services.
    Response: After the full consideration of Comments on this issue, 
the Department declines to add a definition of abortion to the rule. As 
indicated by the Comments, such questions over the nature of abortion 
and the ending of a life are highly controversial and strongly debated. 
The Department believes it can enforce the federal health care 
conscience protection laws without an abortion definition just as the 
Department has enforced Hyde Amendment, Consolidated Appropriations 
Act, 2008, Public Law 110-161, Div. G, Sec. Sec.  507, 508(a)-(c), 121 
Stat. 1844, 2208 (Dec. 26, 2007), abortion funding restrictions without 
a formal definition. Additionally, nothing in this rule alters the 
obligation of federal Title X programs to deliver contraceptive 
services to clients in need as authorized by law and regulation.
    Comment: Comments requested that the Department define many other 
terms or phrases that are used in the regulation. Some Comments 
suggested that the Department adopt a narrow definition of the term 
``discrimination'' and make clear that the reassignment of an employee 
who states a religious or moral objection to a certain activity (such 
as abortion) does not constitute discrimination.
    Response: The Department believes that these terms are sufficiently 
clear, and do not need further definition. The Department does not 
believe that a definition of the statutory term ``discrimination'' is 
necessary. The term ``discrimination'' is widely understood, and 
significant federal case law exists to aid entities in knowing what 
types of actions do or do not constitute unlawful discrimination. The 
Department expressly rejects the suggestion that the reassignment of an 
employee who states a religious or moral objection to a certain 
activity (such as abortion) may not constitute discrimination in all 
cases. Like most discrimination cases, the outcomes are dependent on 
the facts. It seems likely that there are situations where the 
reassignment of an employee for the refusal to perform a specific 
procedure could constitute unlawful discrimination. Likewise, the 
Department recognizes that circumstances exist where the reassignment 
of such an employee would not constitute unlawful discrimination. We 
encourage employers subject to the rule to have discussions with their 
employees that lead to mutually agreeable resolutions.
    Comment: Some Comments asked that the Department define the terms 
``religious belief'' and ``moral conviction'' to ensure that they would 
not be interpreted broadly.
    Response: The Department declines to adopt particular definitions 
of these terms because the common definitions are plainly understood, 
and the Department intends that common sense interpretations apply. A 
well-defined body of federal law exists in this general topic, and the 
U.S. Supreme Court has repeatedly clarified that these terms are to be 
read broadly.

C. Comments: on Proposed New Sec.  88.3--Applicability

    No Comments were received specifically pertaining to this section.

D. Comments on Proposed New Sec.  88.4--Requirements and Prohibitions

    No Comments were received specifically pertaining to this section.

E. Comments on Proposed New Sec.  88.5--Written Certification of 
Compliance

    Comment: Several Comments stated that the requirement for written 
certification in proposed section 88.5 would be duplicative or 
unnecessary because current regulations already require written 
certification of compliance with federal nondiscrimination and civil 
rights laws. Other Comments suggested that the certifications be 
modified in order to avoid confusion on the part of recipients and sub-
recipients.
    Response: We find that a specific written certification is 
necessary to protect institutions under these laws. Many recipients 
(and sub-recipients) of Department funds currently must certify 
compliance with certain listed federal nondiscrimination laws, yet 
federal health care conscience protection laws are separate laws not 
specifically mentioned in existing forms. As part of a broad effort to 
raise awareness in the public, in the health care community, among 
recipients of Department funds, and among protected individuals and 
institutions, of their rights and responsibilities under existing 
federal

[[Page 78078]]

health care conscience protection laws, as well as to facilitate 
enforcement of these laws, the regulation requires certain recipients 
and sub-recipients of Department funds to certify their compliance in 
writing. Wherever possible, Department programs will attempt to 
integrate certifications required under this regulation into existing 
forms.
    The Department has modified the certifications in section 88.5. 
They have been made clear so that recipients and sub-recipients know, 
by means of the certifications themselves, with which provisions they 
must comply based on the type of entity the recipient is or the type of 
funding mechanism through which they receive funds.
    Comment: Comments asserted that the Department is overstepping its 
authority by making compliance with the federal health care conscience 
protection statutes a condition of payment, stating Congress has not 
made compliance a condition of payment and would have said so if that 
were its intent.
    Response: The Department disagrees that the proposed rule exceeds 
its authority. It is important to emphasize that the Department and 
recipients of Department funds, including State and local governments, 
are obligated to comply with the health care protection conscience laws 
that have been in effect for many years, which prohibit federal funds 
from being used in a discriminatory or coercive manner against 
institutional and individual health care entities and workers for their 
participation or refusal to participate in abortions, other certain 
medical procedures, health services, or research activities that they 
find objectionable on religious or moral grounds. By employing existing 
regulatory enforcement measures to ensure compliance with such 
statutory requirements under 45 CFR parts 74, 92, and 96, as well as 
other measures, the Department does not exceed its authority, but 
rather is carrying out its obligation to enforce existing laws.

F. Comments Received in Response: Specific Requests for Comments in the 
Proposed Rule

Current Awareness of and Compliance With Provider Conscience 
Protections
    Comment: This regulation implements existing federal health care 
conscience protection laws contained in the Church Amendments, the 
Public Health Service Act Sec.  245 and the Weldon Amendment. Several 
Comments objected to the regulation on the grounds that these laws were 
sufficient in themselves and that their implementation by regulation 
was unnecessary or redundant. Generally, these Comments suggested that 
the health care field is sufficiently aware of the statutory 
protections available for provider conscience, and that no further 
regulatory effort was required in order to provide awareness of these 
laws or to assure compliance with them. Several other Comments, 
however, reported widespread lack of knowledge regarding these laws and 
inconsistent application of them. These Comments generally supported 
the regulation as a necessary and useful mechanism to support statutory 
protection. In addition, numerous Comments reported what they believed 
to be individual instances of violation of conscience, including health 
care providers suffering loss of employment, adverse actions during 
medical training, and discrimination in residency placement, among 
other consequences, due to their assertion of their conscience rights. 
Some Commenters also reported pressure to perform certain procedures 
from State authorities, professional organizations, or employers that 
appeared to the Commenters to be inconsistent with federal conscience 
protections.
    Response: The Comments received in Response to the proposed rule 
support the Department position that the regulation is necessary to 
implement the statutes. While many people in the health care field may 
have general knowledge that conscience protections exist for providers, 
the scope of these protections is not always widely understood. Because 
Congress has enacted several different protections, an individual or 
organization may be aware that, for instance, a physician may not be 
compelled to perform abortions, but may not be aware of other aspects 
of the statutes providing conscience protection. Others may become 
aware of these laws, at least in detail, only when a dispute arises and 
a provider or entity attempts to assert their conscience rights; there 
may be subsequent disagreement over the nature of the rights asserted. 
The Department believes that coordinating the several related statutory 
protections, by incorporating their various requirements into this 
regulation, will allow for greater clarity and awareness of these 
protections within the health care field, in conjunction with other 
public education efforts connected with this regulation. In addition, 
the issuance of a regulation will allow for greater ease of 
administration, provide a Departmental point of contact for complaints 
regarding violations of the statutes and this regulation, and provide a 
uniform mechanism for investigating complaints of noncompliance. The 
types of noncompliance reported by Commenters are expected to be 
reduced as a result of this regulation.
Methods To Address Compliance Problems and Increase Awareness
    Comment: Commenters who supported and opposed the rule both noted 
that the Department must increase awareness of health care provider 
conscientious objection rights, and the obligations this rule may pose 
for employers, entities, and States. Some Commenters also responded to 
the Department's request for Comments on methods which may be used by 
the Department and others to increase awareness among health care 
providers of their rights under laws protecting providers from 
discrimination for exercising their conscience rights.
    Commenters who opposed the rule suggested that, as an alternative 
to further federal regulation, the Department should prepare and 
distribute informational materials to individual and institutional 
health care providers and State and local governments, and make these 
materials available on the HHS Web site. A Commenter also proposed that 
the Department develop continuing education courses for health care 
practitioners and attorneys, and that existing certifications that 
recipients of Departmental funds must currently sign could be modified 
to achieve the objectives of the rule.
    Response: The Department agrees that the suggestions offered by 
Commenters of mechanisms for improving awareness of conscience rights 
among health care providers would increase the effectiveness of the 
rule. However, the rule seeks to achieve not only greater awareness of 
provider conscience rights, but also a more consistent understanding of 
the scope of these rights (and the corresponding obligations), greater 
ease of administration, provision of a Departmental point of contact 
for complaints regarding violations of the statutes and this 
regulation, a uniform mechanism for investigating complaints of 
noncompliance, and, as a result, greater compliance with the laws 
protecting these rights.
    Comment: Commenters who supported the rule also offered suggestions 
on how both the Department and covered entities could increase 
awareness of the legal protections for health care provider conscience. 
Among the suggested activities were posting notices in high-traffic 
areas of buildings receiving

[[Page 78079]]

Department funds, providing information within educational programs 
that receive Department funds, including information in applications 
for training, applications for residency programs, and private 
insurance plans benefit descriptions, posting information on the 
Department or provider Web sites, including of information in employee 
handbooks, and sending e-mail or postal communications directly to 
providers. Comments were made on how to best attract attention to such 
postings by making them distinct from other materials in which they 
might be included.
    Response: The Department agrees that these suggestions would 
contribute to significantly greater public awareness of health care 
provider conscience protections. The Department encourages covered 
entities to undertake such public awareness activities. The Department 
also recognizes that it must undertake reasonable outreach efforts in 
order for the rule to be effective at increasing awareness of, and 
compliance with, provider conscience protections in the statutes and 
this implementing regulation. Thus, the Department will consider all 
avenues available for increasing public awareness of health care 
conscience protection laws. Requiring certification of compliance by 
entities receiving Department funds provides an important vehicle for 
increasing awareness of health care conscience protection laws and 
ensuring compliance with them.
    Comment: Some Comments declared that the description of notice/
posting of health care provider conscience protections in the proposed 
rule should be enhanced. One argued that posting of notices on bulletin 
boards, where they appear among multiple notices, is not a very 
effective way of communicating the protections afforded under the 
regulation and statutes. Other Comments requested that notices of 
federal health care conscience protection statutes should be 
conspicuous and posted in such locations as provider offices and 
pharmacies and in such public communications as advertising, health 
plan promotion materials, Medicaid literature, Web sites, as well as 
applications for training, residency, and educational programs, and in 
employee/volunteer handbooks.
    Response: The Department agrees that informing health care entities 
of their rights and responsibilities under federal health care provider 
conscience provisions is important to ensuring institutional and 
individual conscience rights are protected. Consequently, the 
Department encourages covered entities to undertake such educational/
public awareness activities. Within its statutory authorities, the 
Department is exploring a number of options, including many of those 
suggested by Comments as well as others, to provide further public 
education and notice of federal health care conscience protection laws 
and this regulation.
Exceptions to the Written Certification Requirement in Proposed New 
Sec.  88.5
    Comment: Several Comments expressed concern that the certification 
requirement would create an administrative burden, and one Commenter 
suggested that the Department should not impose the certification 
requirements of the regulation on every Department grantee regardless 
of the grant's purpose.
    Response: In its Notice of Proposed Rule Making, the Department 
solicited Comments on whether further exceptions should be made from 
certification requirements for recipients or sub-recipients of federal 
funds, where such recipients or sub-recipients receive Department funds 
for purposes unrelated to the provision of health care or medical 
research. Because there is concern among Commenters over any burden of 
a certification, including that stemming from certifications required 
without regard to a grant's purpose, and because there appears to be 
little objection to limiting the certification requirement in the way 
put forth for Comments in the proposed rule, the Department has 
determined to make further exceptions to the certification requirement 
for Departmental programs whose purpose is unrelated to health care 
provision, including certain programs currently administered by the 
Administration for Children and Families and the Administration on 
Aging. These programs often involve the provision of grants to States 
and other governments, or cash assistance or vouchers rather than 
direct services, and they are not likely to involve medical research, 
the participation of health care providers, or referral to health care 
providers. These programs are unlikely to encounter the circumstances 
contemplated by this regulation, and therefore the assurance of 
compliance represented by a certification is not considered necessary 
by the Department for such programs. The regulatory text has been 
changed by addition of sections 88.5(e)(4) and (e)(5), together with 
associated language and example programs in the preamble. Finally, in 
section 88.5(e)(6), we provide an exception from the written 
certification requirement for Indian tribes and tribal Organizations 
when contracting with the Indian Health Service under the Indian Self-
Determination and Education Assistance Act. Of course, these entities 
must still comply with the relevant statutes, even if they are not 
under an obligation to make a certification.
Should Language Specify Written Certification Is a Material 
Prerequisite to Payment of Department Funds
    Comment: The Department requested Comments on whether written 
certification of compliance with nondiscrimination provisions should 
contain language specifying that the certification is a material 
prerequisite to the payment of Department funds. The Department 
received a number of Comments in Response to this request, both in 
favor of and against including such language in the written 
certification of compliance. Those in favor of including material 
prerequisite language felt that such language was important as part of 
the written certification process to protect individuals and 
institutions from discriminatory treatment. Others stated that 
certification should not be a prerequisite for Department funding, 
noting that explicitly tying payment to compliance with the 
certification requirement would subject the certification process to 
the federal False Claims Act. One Commenter stated that, absent more 
explicit guidance on the policies and practices that will satisfy 
compliance, written certification should not be a material prerequisite 
to payment of Department funds.
    Response: The Department does not consider the written 
certification of compliance to be a material prerequisite to the 
payment of Department funds any more than in any other similarly worded 
statute or regulation. As stated above, the Department intends to work 
with recipients and sub-recipients of Department funds to ensure 
compliance with the requirements or prohibitions promulgated in this 
regulation, and, if such assistance fails to achieve compliance, the 
Department will consider all legal options, including termination of 
funding and return of funds paid out in violation of health care 
conscience protection provisions under 45 CFR parts 74, 92, and 96, as 
applicable.

G. General Comments

    Comment: Many Comments stated concern that the proposed regulation 
could serve as a pretext for health care workers to claim religious 
beliefs or moral objections under the protections

[[Page 78080]]

of the fourth provision of the Church Amendments, 42 U.S.C. 300a-7(d), 
in order to discriminate against certain classes of patients, including 
illegal immigrants, drug and alcohol users, patients with disabilities 
or patients with HIV, or on the basis of race or sexual preference.
    Response: Comments offered a number of hypothetical situations 
where individual health care workers might attempt to discriminate 
against individuals on a variety of grounds, using provider conscience 
as a pretext, and have suggested that the proposed regulation would 
permit such activity. Many of the described hypothetical situations are 
vague or lack substantial detail, but to the extent that the Comments 
suggest that the regulation permits unlawful discrimination, we 
disagree. It is important to emphasize that the health care provider 
conscience protection provisions have existed in law for many years, 
and that this regulation only implements these existing requirements. 
As a result, there is nothing in this regulation that newly permits the 
types of actions described in Comments. It is also important to 
emphasize that the health care conscience protection laws exist as one 
part of a number of federal laws that address discrimination on a 
variety of grounds, and that the actions described in the hypothetical 
situations that violate federal civil rights laws, continue to violate 
federal civil rights laws.
    We do not believe there is a conflict between the operation of 
health care conscience protection laws and other federal laws. Congress 
has enacted a network of laws that govern different activities, and we 
believe proper meaning can be given to all of them. There are several 
federal civil rights laws intended to protect individuals from 
discrimination in programs receiving federal financial assistance or in 
public accommodations based on their individual characteristics (e.g., 
race, color, national origin, disability, age, sex and religion). In 
the former, the individuals protected by these laws typically are 
beneficiaries of, or applicants for, services and activities provided 
through federally funded programs. The health care conscience 
protection laws have a different purpose, protecting individual health 
care workers and entities from discrimination in connection with 
particular practices such as abortion, or from compulsion to perform 
health care activities that they find religiously or morally 
objectionable. As such, these two sets of laws are intended to protect 
different populations and on different grounds. On their face, there is 
no inherent inconsistency or conflict between these laws.
    How various federal laws would apply to any particular situation 
depends largely on the facts of the situation. Thus, it is 
inappropriate to make definitive statements about legal outcomes in 
Response to the many scenarios raised in Comments. Entities subject to 
these laws are responsible for ensuring against illegal discrimination 
in providing health care services to the public, while also protecting 
the conscience rights of the health care workers who are affiliated 
with these entities. Because these laws do not on their face conflict, 
we believe it is possible in most situations for entities to act 
without violating any applicable federal laws. In many cases, for 
example, entities may accommodate health care worker conscience 
rights--while ensuring that all eligible patients are served, including 
members of federally protected classes--by managing the workforce to 
ensure sufficient coverage.
    Many of the scenarios raised in Comments involved health care 
workers hypothetically discriminating against particular individuals on 
legally impermissible grounds (e.g., race or disability). To the extent 
these scenarios implied that the health care conscience protection laws 
protect workers who object to providing services based on an 
individual's federally protected characteristics, we disagree. We 
believe such actions are outside of the scope of the health care 
provider conscience protections. Those laws protect health care 
workers' conscience rights with respect to particular actions or 
activities, not with respect to an individual's characteristics that 
are protected by federal law. To the extent there are actual conflicts 
between any of the health care conscience protection laws and federal 
civil rights laws, an entity would be required to comply with federal 
civil rights requirements.
    Where the federal health care conscience protection laws and the 
civil rights laws are both conditioned on the receipt of federal 
funding, application of rules of statutory construction require 
continued compliance with federal civil rights laws. The health care 
conscience protection laws would not be interpreted to impliedly repeal 
federal civil rights requirements. Moreover, given the strong national 
policies embodied in federal civil rights laws that protect individuals 
from unlawful discrimination based on their federally protected 
individual characteristics, and that ensure that federally supported 
programs are available to all without discrimination, we believe that 
federal civil rights protections prevail.
    Comment: A number of Comments argued that the proposed regulation 
would limit patient access to basic reproductive health care services, 
including contraceptive services. Many Comments also asserted that the 
proposed regulation would disproportionately affect certain sub-
populations, including low-income patients, minorities, the uninsured, 
patients in rural areas, the Medicaid population, or other medically 
underserved populations. Some Comments further warned of health 
consequences, such as an increase in unintended pregnancy, should the 
proposed rule be promulgated. Finally, several Comments expressed 
concern that the proposed rule would limit access to emergency 
procedures, such as emergency contraception for rape victims, surgery 
for ectopic pregnancies, and other services.
    Response: The Department recognizes that access to health care 
services is a challenge facing the entire health care system, and that 
it is not a challenge restricted to the context of reproductive health 
services. In recent years, the Department has proposed or implemented 
several important initiatives aimed at increasing access to quality 
health care, including by providing health care services for the poor, 
elderly and disabled; increasing access to quality medical care through 
expansion of the federal Community Health Center program; proposing to 
support and encourage States' efforts to work with the private 
marketplace to help ensure affordable health insurance; and supporting 
the enactment of proven medical liability reforms that increase patient 
access to quality medical care. The Department supports continuing such 
efforts into the future in addressing barriers to affordable, quality 
health care.
    We disagree that this regulation would create new limitations on 
health care access, including basic reproductive health care services, 
services provided by publicly funded clinics, and health care services 
provided in emergency situations. First, this regulation does not 
expand the scope of existing federal laws, some of which have been in 
place for many years, protecting health care entities from 
discrimination on the basis of provider conscience with respect to 
abortion and certain other services to which a provider may have 
religious or moral objections. The Department has a duty to enforce 
these laws applying to recipients of Department funds. Even absent the 
issuance of this final rule,

[[Page 78081]]

recipients of Department funds are still required to comply with these 
laws; this regulation is intended to raise awareness of the laws among 
the public, protected health care entities, and recipients of 
Department funds, as well as to provide for enforcement of federal 
conscience protections.
    Second, the current shortage of health care providers in certain 
areas of the country provides additional justification for protecting 
conscience rights. Many Comments we received, including those of many 
health care providers, stated that forcing providers to perform or 
participate in procedures that violate their consciences discourages 
individuals from entering or remaining in careers in the health 
professions. One Commenter wrote, ``by insisting that those who are 
willing to violate their consciences in the delivery of health care are 
the only persons who should enter the health care field, one 
contributes to the creation of a health care delivery system of 
professionals who blindly follow directives rather than conscience, 
putting society at risk.'' Unlike some Commenters, we believe that 
problems of access to health care can be resolved without requiring 
health care providers to violate their conscience. By protecting 
conscience rights in accord with federal law, we wish to encourage more 
individuals and institutions to participate in Department-funded health 
service programs in accord with their consciences and, thereby, 
increase access to quality health care services.
    Third, with regard to contraceptive services, the Department 
continues to support efforts to make safe and effective contraceptives 
and family planning services available to women--and men--who cannot 
otherwise afford them. This regulation will ensure that such programs 
are carried out in a way that is consistent with existing federal 
health care conscience protection laws. While Comments posed many 
hypothetical situations in which they claimed access to contraceptive 
services would be limited, we have found no evidence that issuing these 
regulations to better ensure compliance with existing federal health 
care conscience protection laws will create additional barriers to 
accessing contraceptive services.
    Fourth, we note that many Commenters who believed that this rule 
will significantly restrict access to contraceptives or increase teen 
pregnancies also submitted Comments stating that the rule was 
unnecessary because health care provider conscience protection laws are 
being followed and no provider rights are currently being violated. 
These two statements are contradictory. If access to any service 
significantly declined with the implementation of this rule and all 
other factors remained unchanged, that fact could be evidence that 
health care providers in question had previously been compelled to 
deliver the service over their conscience objections.
    Comment: Comments argued that any revised rule should include 
guidance discussing ways to balance the rights of providers and 
patients, and one Commenter stated that any final rule should contain 
``a forceful statement of patients' rights to receive health care 
services in accordance with their religious beliefs or conscience.'' 
The Commenter also argued that any certification should require health 
care entities to certify that the rights of patients are respected to 
the extent required by law.
    Response: Patients' ability to access health care services, 
including abortion and reproductive health services, is long-
established and is not changed in this rule. In issuing regulations 
implementing federal laws protecting health care entities' conscience 
rights, we recognize that many current or prospective recipients of 
Department funds must already certify or assure their compliance with 
certain federal nondiscrimination laws as a part of existing funding 
applications. We also encourage all participants in the health care 
system, including patients, health care providers, and those entities 
receiving Department funds, to review existing laws, regulations, and 
guidance, including the U.S. Constitution and federal laws enacted by 
Congress prohibiting discrimination by health care entities receiving 
certain federal funds. (For more information on these issues, visit the 
Web site of the Office for Civil Rights of the Department of Health and 
Human Services at http://www.hhs.gov/ocr.) We also encourage full and 
open communication between patients and providers on sensitive issues 
surrounding the provision of health care services, including issues of 
morality and conscience. Patients are best served when their providers 
communicate clearly and early about any services they decline to 
provide or participate in. We similarly encourage full and open 
communication between providers and their employers or the entities 
with which they have privileges on issues concerning the services the 
provider may be unwilling to perform. This would facilitate the 
appropriate accommodation of a provider's religious or moral objections 
to particular services, while at the same time enabling the employer/
institution to meet the needs of its patients.
    The Department seeks to strike a careful balance between the health 
care provider conscience protections provided in federal law, on the 
one hand, and patients' needs and the needs of the health care system 
on the other hand. A health care system that is intolerant of 
individual conscience, certain religious beliefs, ethnic and cultural 
traditions, or moral convictions serves to discourage individuals with 
diverse backgrounds and perspectives from entering the health care 
professions, further exacerbating health care access shortages and 
reducing quality of care. It is more likely to lead to situations in 
which a patient is receiving services or procedures from a provider who 
is not fully committed to the choice of care. We seek a health care 
field in which patients can be more confident that their provider 
shares their views and concerns as identified through mutually open 
communication. The final regulation takes a cautioned and balanced 
approach to ensure compliance with federal health care conscience 
protection laws by defining key terms, stating requirements and 
prohibitions, and requiring certain recipients and sub-recipients of 
Department funds to provide written certification of compliance. In so 
doing, we wish to promote diversity in the health professions, 
increasing access to health care services.
    Comment: Some Comments expressed concern that the proposed rule 
could restrict access to contraceptives which are being used for 
purposes other than preventing pregnancy or are being used in 
conjunction with other medical treatments.
    Response: According to 42 U.S.C. 300a-7(d), which applies to any 
program funded in whole or in part under a program administered by the 
Department, no protected individual may be required to perform or 
assist in the performance of any part of a health service program or 
research activity funded in whole or part under a program implemented 
by HHS contrary to that individual's religious beliefs or moral 
convictions; the motivation of the patient or intended use of the 
service is irrelevant under the statute. We note that nothing in this 
rule changes the obligations of the federal Title X program or Medicaid 
to deliver contraceptives to eligible patients in need. However, we 
reiterate that we have found no evidence that these regulations will 
create new barriers in accessing contraception unless those 
contraceptives are currently delivered over the religious or moral 
objections of

[[Page 78082]]

the provider in such programs or research activities.
    Comment: Some Comments requested the creation of a hotline to 
report patient access to care problems.
    Response: Again, we do not anticipate a reduction in access to 
legal health services as a result of this regulation, much less a 
significant enough change to warrant the creation of a hotline. As a 
result, we decline to create a specific hotline solely to report 
patient access to care problems as part of this regulation. However, we 
encourage members of the public to visit http://www.hhs.gov/about/referlst.html for a list of available hotlines and information 
resources regarding Department programs and activities.
    Comment: Comments asserted that the proposed rule, if finalized, 
would disrupt the ethical and legal requirements of providers to obtain 
informed consent from their patients. Commenters argued that principles 
of informed consent require health care providers to inform patients 
about all treatment options or reasonable alternatives, including those 
to which they object or refuse to perform because it would violate 
their consciences.
    Response: We recognize that informed consent is crucial to the 
provision of quality health care services. This final rule raises 
awareness and provides for the enforcement of federal laws, some of 
which have been in effect for many years, protecting the conscience 
rights of health care entities. We are aware that nearly all States 
have laws protecting health care practitioners' rights of conscience to 
some degree or another, many providing full exemptions to any health 
care practitioner who conscientiously refuses to participate in an 
abortion. Over the last four decades, medical professional 
associations, such as the American Medical Association (AMA), have 
reaffirmed the rights of physicians and other health care personnel to 
practice medicine without violating their moral principles.\3\ Despite 
the widespread and sustained existence of federal and State laws 
protecting the consciences of health care providers, we have found no 
evidence that protecting conscience rights disrupts the informed 
consent process between providers and patients. Rather, we believe the 
provider-patient relationship is best served by open communication of 
conscience issues surrounding the provision of health care services, 
including any conscientious objections providers or patients may have 
to providing, assisting, participating in, or receiving certain 
services or procedures.
---------------------------------------------------------------------------

    \3\ See, e.g., AMA House of Delegates Policy H-5.995 (issued 
1973; reaffirmed 1986, 1996, 1997, and 2000).
---------------------------------------------------------------------------

    To avoid potential conflicts from occurring, we emphasize the 
importance of and strongly encourage early, open, and respectful 
communication between providers and patients surrounding sensitive 
issues of health care, including issues of conscience, so that both 
parties' consciences are respected as patients are provided with 
necessary information to make informed decisions about their health 
care and choice of provider. We disagree that health care providers' 
consciences must be violated in order to meet requirements of informed 
consent in the provision of medical services.
    Comment: Several Comments asserted that the proposed regulation 
could negatively impact and potentially hinder scientific research, 
arguing that hospital, academic, nonprofit, and corporate research 
activities that receive Department funds could have difficulty 
fulfilling their research contracts if workers were allowed to refuse 
participation. Offering several research activities as examples, 
Comments argued that Department-funded research institutions could be 
compromised because of personnel objections to conducting or supporting 
the research conducted there. Other Comments argued that health care 
quality and safety will be compromised by the proposed regulation 
because of the refusal of staff to do their jobs. Similarly, some 
Comments expressed concern that the regulation will adversely impact 
the academic rigor of medical education. They argued that professors at 
publicly funded medical schools could refuse to teach medical 
procedures or information they find morally objectionable, which would 
reduce the quality and breadth of medical education.
    Response: The Department does not find evidence supporting the 
Comments' assertions. In enacting federal health care conscience 
protection laws, including the Church Amendments, PHS Act Sec.  245, 
and the Weldon Amendment, Congress has clearly stated a policy that 
Department funding should not support coercive or discriminatory 
practices that violate individual conscience. The Church Amendments 
contain specific provisions relating to scientific research, while both 
the Church Amendments and PHS Act Sec.  245 contain provisions applying 
to physician training and other training programs in the health 
professions regarding abortion and sterilization. Some provisions of 
the Church Amendments, for instance, which specifically mention 
scientific research (42 U.S.C. 300a-7(c)(2), ``biomedical or behavioral 
research,'' ``research activity''; 42 U.S.C. 300a-7(d), ``research 
activity'') and discrimination against applicants for training or study 
(42 U.S.C. 300a-1(e)), have been in effect for over three decades. PHS 
Act Sec.  245 has been in effect since the mid-1990s. The Department is 
unaware of evidence showing a negative impact of federal conscience 
provisions on Department-funded scientific research, health services 
programs, training, or instruction in the health professions; nor have 
Comments provided evidence supporting the claim that regulations 
implementing existing federal conscience protections and requirements 
would hinder such activities. We also disagree with the Commenters' 
assertions to the extent that Commenters suggest that institutions must 
require health care providers to violate their consciences in order to 
conduct health services, training, or research activities.
    Comment: Comments expressed concern that the proposed regulation 
will expand the ability of insurers to refuse to provide health care 
services, information, and referrals to patients. Other Comments 
expressed concern that the regulation could impact funding for programs 
that benefit immigrants or victims of domestic violence.
    Response: As previously stated, this regulation does not expand the 
scope of existing federal conscience protections for health care 
entities, including health insurance plans. Rather, it provides for 
Departmental implementation and enforcement of existing federal health 
care conscience protection laws and educates the public and the health 
care community about laws protecting the consciences of health care 
entities that refuse to participate in abortions or other services in 
the case of Departmental grantees. We are unaware of any way in which 
the regulation could impact funding for programs that benefit 
immigrants or victims of domestic violence.
    Comment: One Commenter thought the rule would increase spending and 
add a significant strain on Medicaid.
    Response: We have not found evidence supporting the Commenter's 
assertion that the final rule would increase spending in Medicaid, in 
part because this final rule does not expand the scope of existing 
federal health care conscience protection laws, some of which have been 
in place for over thirty years.
    Comment: Several Comments disagreed with the Department's assertion 
in the proposed rule that the

[[Page 78083]]

regulation will not have an impact on family well being. Another 
Commenter stated that the Treasury and General Government 
Appropriations Act of 1999 requires the Department to determine if the 
proposed rule would affect family well-being. The Commenter stated 
that, if family well-being is affected, the Department must provide an 
impact assessment of these effects. The Commenter also stated that the 
proposed rule does not adequately address the impact on family well-
being.
    Response: As stated in the proposed rule, the Department has 
determined that the final rule will not affect family well-being within 
the meaning of section 654 of the Treasury and General Government 
Appropriations Act, 1999, enacted as part of the Omnibus Consolidated 
and Emergency Supplemental Appropriations Act, 1999 (Pub. L. 105-277, 
112 Stat. 2681). This final rule defines certain key terms, ensures 
that recipients of Department funds know about their legal obligations 
under existing federal health care provider conscience protection 
provisions, and requires written certification by certain recipients 
that they will comply with such provisions, as applicable.
    Comment: Some Comments asserted that the proposed regulation 
follows from general laws restricting religious discrimination, such as 
Title VII of the Civil Rights Act of 1964, or the religious exercise 
clause of the First Amendment to the United States Constitution. 
Commenters on this topic disagreed over whether this suggested 
connection made the regulation necessary to implement core 
constitutional principles, or unnecessary because these rights are 
protected in other ways. Commenters pointed out current grantees, for 
instance, already certify to obey all nondiscrimination laws, and that 
a specific certification on conscience protection, as contemplated in 
the proposed regulation, would not be necessary.
    Response: The Department agrees with Comments noting that federal 
health care conscience protections are consistent with constitutional 
and other statutory protections of religious belief and moral 
conviction. However, Congress has enacted specific and detailed 
legislation in the area of health care provider conscience applicable 
to recipients of certain federal funds which is broader in scope than 
protections afforded under Title VII and the other examples cited by 
some Commenters. Because they implement health care-specific statutory 
provisions applicable to recipients of certain federal funds, these 
regulations offer more administrable and directive guidance than do 
other existing laws prohibiting religious discrimination. Many 
organizations and individuals may not be aware of the scope of the 
conscience protections or their relationship to other federal 
nondiscrimination laws when certifying compliance with the latter. The 
Department believes that the responsibilities of certifying entities 
will be made clearer by a certification that explains federal health 
care conscience protection laws explicitly.
    Comment: A few Comments suggested that the Department should gather 
more evidence of noncompliance before regulating in this area, for 
example, by commissioning a national survey to determine the prevalence 
of civil rights violations of provider conscience, and that, in the 
absence of statistical evidence that a significant number of violations 
are occurring, refrain from issuing implementing regulations.
    Response: The Department disagrees that such a survey is a 
necessary precondition to issuing this regulation. The basis for the 
regulation is the existence of the several federal health care 
conscience protection laws. There are a number of purposes served by 
regulating in this area, including, but not limited to, making the 
health care community more aware of these rights and clarifying their 
scope through the exercise of agency expertise, as well as assuring 
compliance. The Department has good reason to believe that there are 
risks of non-compliance. By their nature, civil rights protections 
create responsibilities for entities such as recipients of federal 
funds or employers to do things they otherwise may not do. It has been 
the Department's experience that, in the absence of a clear statement 
of responsibilities, civil rights are less effectively exercised. 
Commenters did not indicate what they believed would be an 
``acceptable'' level of civil rights violations preventable by this 
regulation. The Department's goal is compliance with federal law. In 
Response to the proposed rule, numerous Comments were received, 
including from those in the health care community, that indicated 
serious misunderstandings regarding statutory health care provider 
conscience protections, or which expressed a narrower view of the scope 
of these protections than is consistent with the Department's 
interpretation. Especially in light of the additional Comments alleging 
violations of conscience protection, this Commentary reinforces the 
Department's view that, in the absence of a clear statement of 
responsibilities, there is a serious risk that, either from 
misunderstanding or from a groundless and overly narrow view of health 
care provider conscience rights, these conscience rights will not be 
fully protected. How often these violations occur is not known, and it 
is unclear whether a valid survey could be conducted to determine this 
figure. Some health care providers may not at this time be aware their 
rights are being violated when they are compelled to act against their 
conscience, or they may not attempt to report such violations. As a 
result of this regulation, a procedure will be put in place to receive 
and compile complaints, extend protection to those who make them, and 
the complaints will be reviewed for validity. Consequently, a more 
reliable estimate of the prevalence of actual violations is likely to 
be obtained, which will enable the Department to track the extent of 
noncompliance over time.
    Comment: Several Comments were concerned about the absence of 
implementation guidance in the proposed rule for communication of a 
provider's individual conscience objections to entities and to 
patients. Commenters presented a variety of suggestions for additional 
guidance in the rule concerning communication of a health care provider 
with his or her employer and patients. Several Comments recommended a 
requirement that employees submit a written statement of their 
conscience objection or objections. Some Comments suggested a 
requirement for posting or providing notice of limitations to health 
care services provided at a facility or office. One Commenter pointed 
out that the State of Illinois requires pharmacies that do not carry 
emergency contraception to post a sign directing patients to other 
pharmacies that do.
    Response: We strongly encourage early, open, and mutually 
respectful communication of conscience concerns that may arise in the 
provision of medical services, including between employees and 
employers as well as between providers and patients. However, we 
concluded that it was neither feasible nor prudent in this final rule 
to provide specific guidance on methods and means for such 
communication given the vast array of circumstances and settings in 
which communications regarding conscience are likely to take place.
    Comment: Comments stated that the proposed rule did not clarify 
what safeguards health care facilities were required to have in place 
when a medical professional refused to provide a particular service.

[[Page 78084]]

    Response: In general, the Department acknowledges that not every 
institutional or individual health care provider offers every legal 
health service, and requiring them to do so would be neither 
appropriate nor prudent. At the same time, we encourage and expect 
health care facilities to take measures to protect conscience rights 
while ensuring access to health care services. The myriad number of 
circumstances occurring across different health care settings where the 
need to protect conscience rights may arise leads us to decline to 
prescribe particular measures in this final rule. Because federal 
health care conscience protection laws have been in place for many 
years, we fully expect health care entities to take the necessary steps 
to protect conscience rights while meeting the needs of their patients.
    Comment: Another Commenter stated that the proposed rule does not 
address whether refusal to perform a service must be a consistent, 
across-the-board refusal, or whether it can be a ``graded refusal.'' 
For example, the proposed rule does not clarify if an employee can 
refuse to schedule sterilizations for young or single women but not for 
married women.
    Response: We reiterate here that, for abortion-related activities 
as covered by the Weldon Amendment and Public Health Service Act Sec.  
245, a health care entity's refusal can be on any ground. (42 U.S.C. 
300a-7(d), which applies to any program funded in whole or in part 
under a program administered by the Department, requires that no 
individual may be required to perform or assist in the performance of 
any part of a health service program or research activity contrary to 
that individual's religious beliefs or moral convictions. For 
involvement in abortion and sterilization as covered by the rest of 42 
U.S.C. 300a-7, again, provisions require that no health care personnel 
be discriminated against for, among other reasons, his/her refusal to 
perform or assist in the performance of a sterilization procedure (or 
abortion) contrary to that professional's religious beliefs or moral 
convictions. Thus, in the case of these statutes, it is the 
individual's religious beliefs or moral convictions that will control 
in a particular case, rather than the frequency of the objection.
    In addition, as we have previously noted, if the decision is being 
made based on an individual's characteristics that are federally 
protected, that is impermissible.
    Comment: Comments argued that if a provider is unwilling to provide 
a certain service, it should give the patient a referral for that 
service. One Commenter asserted that providers should give patients a 
``meaningful referral that will ensure that the patients receive 
continuity of care without facing an undue burden, such as traveling 
long distances or encountering additional barriers to obtaining the 
desired services.''
    Response: Providers who object to participation in abortion or a 
particular health service may provide information on other options, if 
asked, but are under no obligation to do so. First, with respect to 
abortion, both PHS Act Sec.  245 and the Weldon Amendment (among other 
things) specifically prohibit discrimination by the federal government 
and State and local governments, and federal agencies and programs, and 
State and local governments, respectively, against health care entities 
who refuse to refer for abortion. The Department could not enforce such 
a referral requirement without violating these provisions. With respect 
to entities imposing requirements on their employees or members of 
their workforces, the Church Amendments, while not identifying specific 
medical practices or services, uses very broad language to characterize 
the wide array of practices and services to be protected. For example, 
42 U.S.C. 300a-7(d) states that individuals may not be required to 
perform or assist in the performance of ``any part of'' an 
objectionable health service program or research activity. For many 
health care providers, including many who Commented on the proposed 
rule, referral means assisting in the performance of objectionable 
procedures or services such as abortion and would violate their 
consciences. One health care practitioner Commenting on the proposed 
rule stated that referrals are a form of participation in objectionable 
acts, and forcing providers to provide referrals would effectively 
circumvent their moral objection. Federal law recognizes and protects 
the conscience rights of individuals and entities when it comes to 
referral for certain objectionable services. Taking the Church 
Amendments, the Weldon Amendment, and Public Health Service Act Sec.  
245 together, the regulation interprets these three federal laws in a 
way that is consistent with both the letter and the spirit of the law.
    Comment: Some Comments argued that the proposed regulation seems to 
run counter to the Hippocratic Oath's admonition to ``do no harm'' to 
patients. Comments pointed out that health care providers must take 
this oath and agree to treat patients without judgment and provide 
patients with the care they need.
    Response: According to the National Institutes of Health's National 
Library of Medicine (NLM), the Hippocratic Oath is an ancient medical 
text requiring new physicians to swear oaths by a number of deities to 
uphold several professional ethical imperatives, the most widely known 
of which is ``to do no harm.'' Notably, the NLM translation of the 
Hippocratic Oath also includes the prohibitions, ``I will not give a 
lethal drug to anyone if I am asked, nor will I advise such a plan, and 
similarly I will not give a woman a pessary to cause an abortion.'' The 
NLM further states that most medical schools do not require graduates 
to take the Hippocratic Oath. For those physicians who take the 
Hippocratic Oath or other similar oaths, federal law protects health 
care providers whose consciences lead them to recognize that 
participation in certain activities, such as abortion, harms others. 
Conscience is consistent with and is a necessary part of quality care.
    Comment: Commenters expressed concern about impacts on health care 
delivery, burdens and costs (particularly on small employers), and 
overlap with existing protections afforded to protect religious 
conscience of healthcare workers under Title VII of the Civil Rights 
Act of 1964, and suggested that the Department adopt elements of Title 
VII jurisprudence in enforcing these laws. Commenters also stated that 
health care providers must be able to address staffing issues and 
otherwise appropriately screen job applicants to determine if they are 
capable and willing to perform the core services required of the job.
    Response: We do not believe that it is necessary or appropriate to 
incorporate elements of Title VII jurisprudence into this provider 
conscience regulation. Title VII was enacted nine years before the 
first of the health care conscience protection laws was passed; it 
includes specific language with respect to reasonable accommodation and 
undue hardship with respect to religion. In contrast, the Church 
Amendment, the first of the health care conscience protection laws, is 
specific as to its prohibitions, and contains none of the reasonable 
accommodation or undue hardship language Congress elected to include in 
Title VII. This is also true of the additional health care conscience 
protection laws that Congress subsequently enacted. Notwithstanding the 
existence of Title VII, Congress passed a series of laws to explicitly 
protect provider conscience without using Title VII's formulation. 
Moreover, where Title VII is restricted to the

[[Page 78085]]

employment context, the provider conscience provisions are not so 
limited. As a result, we believe it is a reasonable interpretation of 
the statutes that Congress sought to ensure provider conscience 
protections that are distinct from, and extend beyond, those under 
Title VII. The Department's enforcement of the provider conscience laws 
will be informed, for example, by comparison to Title VII religious 
discrimination jurisprudence.
    Congress enacted Title VII of the Civil Rights Act of 1964 to 
protect employees from discrimination by their employers with respect 
to certain individual characteristics, including religion. It applies 
to all employers of a certain size, regardless of whether the employer 
receives federal funding. In the context of the Title VII prohibition 
on employment discrimination on the basis of religion, Congress in 1972 
limited the protection afforded to employees by defining ``religion'' 
as ``all aspects of religious observance and practice, as well as 
belief, unless an employer demonstrates that he is unable to reasonably 
accommodate an employee's or prospective employee's religious 
observance or practice without undue hardship on the conduct of the 
employer's business.'' Under the Title VII standard, an employer is, 
thus, only required to attempt to reasonably accommodate its current or 
prospective employee's religious objections if it would not place an 
undue burden on the employer. In contrast, the health care conscience 
protection provisions apply only to recipients of federal funding, and 
primarily to recipients of funding from the Department, regardless of 
size. Congress was capable of incorporating an express balancing of 
interests in health care conscience protection provisions, but it chose 
not to, in spite of its general familiarity with the balancing test in 
the Civil Rights Act religious nondiscrimination provision. We believe 
that it is reasonable to interpret this action by Congress to impose 
higher standards for provider conscience on employers in the health 
care and medical research that receives Departmental funding than is 
imposed on employers in general. Thus, we believe it is a reasonable 
interpretation that Congress in this context imposed a choice not 
between reasonable accommodations and undue burden, but between 
accommodation of religious belief or moral convictions and federal 
funding. Where an employer will not accommodate an employee's sincere 
religious belief or moral conviction, it may cease being eligible for 
federal funds and lose certain federal funding.
    While it is a reasonable interpretation of the statutes that 
Congress did not intended to limit provider conscience protections to 
those provided to employees under the Title VII legal framework for 
religious accommodation requests, we also interpret nothing in the 
provider conscience statutes as preventing employers from accommodating 
employees' sincerely held religious beliefs, observances, and practices 
when requested as a means of accomplishing the same protections for 
provider conscience. As long as employees in the health care field are 
free from being discriminated against or required to participate in 
abortions or services they find religiously or morally objectionable, 
employers are free to balance employee rights with other interests in 
conducting their business operations. We envision that, through open 
communication between employees and employers about each other's 
respective needs and requirements, and by employers providing 
accommodations of employees' religious beliefs and moral convictions, 
full compliance with the health care conscience protection laws and 
organizational objectives can best be achieved.
    Similarly, we do not foresee that the health care conscience 
protection laws and this regulation would necessarily constrain 
employers in the health care field to hire individuals or accept 
volunteers who, due to their religious beliefs or moral convictions, 
refuse to perform job duties that comprise the significant majority or 
the entirety of duties required by the position.
    There are a number of reasons why these and other staffing concerns 
might not be constrained by protections afforded to health care workers 
on the basis of conscience. First, employers have no obligation under 
the health care conscience protection laws to employ persons who are 
unqualified to perform the functions required of the jobs that they 
seek to fill. A job applicant must be qualified or, typically among a 
pool of qualified applicants, the best qualified, to perform the core 
services of a job for which he/she is applying. It is difficult to 
conceive of a circumstance in which an applicant who is fundamentally 
opposed on religious or moral grounds to a particular medical 
procedure, health service program, or research activity, would be among 
the best qualified to perform that procedure, service, or activity. 
Additionally, a job applicant with a sincerely held religious belief or 
moral conviction against a lawful health service or activity would be 
unlikely to apply for a job in which that precise health service or 
activity constitutes a significant majority or the entirety of the job. 
That said, employers are to be expected to make rational hiring 
decisions based on due consideration of an applicant's knowledge, 
skills, ability, and desire to perform the essential functions of a 
job. To the extent a health care employer's adverse decision is based 
on an applicant's inability to perform the essential functions of a 
job, the decision would not typically constitute discrimination under 
the regulation even if the applicant had expressed an unwillingness to 
perform those functions on conscience grounds. However, an adverse 
decision predicated on an applicant's alleged ``inability'' could 
constitute unlawful discrimination if the employer's stated reasons are 
pretextual; for example, if the employer is using the definition of 
essential functions as a pretext for excluding applicants with certain 
religious beliefs or moral convictions. In applying this standard, the 
Department will remain vigilant against discrimination and the 
potential for employers to use an applicant's qualifications as a 
pretext for unlawful discrimination.
    Comment: Comments requested clarification regarding the application 
of the written certification requirement in the proposed rule to 
programs receiving federal funding under the President's Emergency Plan 
for AIDS Relief (PEPFAR).
    Response: PEPFAR funding is distributed to several federal 
agencies, including the federal Centers for Disease Control and 
Prevention (CDC) within the Department. If the activities of CDC under 
PEPFAR are funded from the annual Labor, Health and Human Services 
appropriations act, the Weldon Amendment would apply, as would certain 
provisions of the Church Amendments.
    To the extent that CDC's PEPFAR programs are funded solely from the 
Department of State appropriations, the Weldon Amendment would not 
apply because the funds for PEPFAR would come from the Department of 
State's appropriations act. The Weldon Amendment applies to funds 
appropriated under the Labor/HHS appropriations act to which the Weldon 
Amendment is a rider. PHS Act Sec.  245, 42 U.S.C. 238n, would not 
apply because section 245 applies to the federal government and to 
State and local governments receiving federal financial assistance. The 
Church Amendments at 42 U.S.C. 300a-7(b), (c)(1) and (e) apply to 
activities funded and carried out under the PHS Act, the Community 
Mental Health Centers Act,

[[Page 78086]]

and/or the Developmental Disabilities Assistance and Bill of Rights Act 
of 2000, and, thus, would not be applicable.
    There are two provisions of the Church Amendments that apply more 
broadly. The Church Amendments at 42 U.S.C. 300a-7(c)(2) applies to 
grants or contracts for biomedical or behavioral research under any 
program administered by the Secretary of Health and Human Services. 
CDC's PEPFAR programs do not customarily involve such research.
    The Church Amendments at 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 part under a program administered by the Secretary of Health 
and Human Services 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.'' 42 U.S.C. 300a-7(d) (emphasis 
added). PEPFAR is a program administered, in part, by HHS. PEPFAR funds 
are appropriated under the State Department's authorities and then 
transferred to HHS and fund grant programs that are developed, 
administered and implemented by HHS/CDC which provide health services, 
including HIV prevention, treatment, and care. Accordingly, CDC's 
PEPFAR programs would be subject to the requirements/prohibitions in 42 
U.S.C. 300a-7(d), and foreign or international organizations (such as 
agencies of the United Nations) which are recipients or sub-recipients 
under CDC's PEPFAR programs may be recipients or sub-recipients for the 
purposes of this rule at CDC's discretion. We note that these 
requirements are consistent with a conscience protection clause already 
existing in the PEPFAR authorizing statute.
    Comment: One Commenter requested clarification on the Office for 
Civil Rights' (OCR) experience and knowledge of employment 
discrimination and how OCR would handle a potential increase in 
workload associated with its role in the proposed rule as the office 
designated to receive complaints of discrimination.
    Response: With a Headquarters office in Washington, DC, ten 
regional and two field offices located throughout the United States, 
OCR promotes and ensures that individuals have equal access to, and 
opportunity to participate in, and receive services from, all relevant 
Department-funded programs without facing unlawful discrimination, and 
that the privacy of their health information is protected. OCR is the 
sole agency within the Department charged with responsibility for 
enforcing these important federal protections. Through the enforcement 
work of its Headquarters policy staff and regional investigators, OCR 
annually resolves more than 12,000 citizen complaints alleging 
discrimination or a violation of the Privacy Rule under the Health 
Insurance Portability and Accountability Act (HIPAA). OCR provides 
training and technical assistance annually to individuals and health 
care entities nationwide that receive certain funds from the Department 
through its public education and compliance activities to promote and 
ensure compliance with applicable federal laws requiring 
nondiscriminatory access to Department programs and services and 
protection of the privacy of individually identifiable health 
information under the HIPAA Privacy Rule. OCR is therefore well-
positioned within the Department to fulfill its designated role as the 
point of contact to receive, and coordinate with the Department-funding 
components the handling of, complaints from individual and 
institutional health care providers and entities seeking protection 
from discrimination in connection with particular practices, or from 
compulsion to perform health care activities, that they find 
religiously or morally objectionable. The Department-funding components 
will bear the actual responsibility for enforcement of the health care 
conscience protection laws through their usual and ordinary program 
mechanisms, which include termination of funding and return of funds 
paid out in violation of the health care provider conscience protection 
provisions under 45 CFR parts 74, 92, and 96.
    OCR also has considerable experience working collaboratively with 
the Department-funding components to identify barriers and implement 
practices that can avoid potential discrimination in services, and also 
in supporting funding components' enforcement responsibilities. For 
example, OCR conducts fully coordinated investigations with the 
Administration for Children and Families (ACF) in its enforcement of 
the Multiethnic Placement Act (MEPA) of 1994, as amended by section 
1808 of the Small Business Job Protection Act of 1996, which provides 
that state agencies may not delay or deny the placement of a child for 
adoption or into foster care on the basis of the race, color, or 
national origin of the adoptive or foster parent, or the child 
involved. OCR and ACF act collaboratively concerning the conduct of 
MEPA investigations and in resolution of MEPA complaints. Pursuant to a 
memorandum of understanding between OCR and ACF, OCR takes the lead in 
investigating violations; when OCR finds a violation of MEPA, ACF 
determines whether to require a monetary payment by the state as part 
of the resolution agreement and whether to require that the payment be 
an integral part of the resolution. In these ways, OCR routinely works 
with the staff of Departmental programs and brings its expertise to 
bear to ensure compliance with federal nondiscrimination requirements.
    With respect to OCR's experience and knowledge in the area of 
employment discrimination complaints, OCR has served as the designated 
entity within the Department to receive a variety of discrimination 
complaints for over 40 years, including employment discrimination 
complaints. OCR's authority covers discrimination based on race, color, 
national origin, age, disability, sex, and religion. OCR's designated 
responsibilities under the provider conscience regulation to receive 
and coordinate the handling of discrimination complaints under the 
statutes and this implementing regulation, with the Departmental 
programs funding the entities at issue in any complaint, therefore, 
fall clearly within OCR's area of expertise and responsibility within 
the Department.
    Comment: One Commenter noted that designating OCR as the office to 
receive complaints appears to overlap with EEOC jurisdiction, and could 
confuse employees as to when and where to file complaints.
    Response: OCR, EEOC, and other federal agencies have developed 
procedures over the years to ensure appropriate handling of federal 
nondiscrimination complaints where there is overlapping jurisdiction.
    The agencies responsible for federal nondiscrimination laws, 
including OCR and EEOC, coordinate to ensure these procedures are 
working and also confer on a case-by-case basis when needed to work out 
instances where there may be shared jurisdiction. As part of this 
coordination, federal agencies, including OCR, use a variety of 
methods, including consumer brochures, fact sheets, grassroots 
meetings, and the Internet, to get information to the public about 
their federal civil rights and when, where, and how to file 
discrimination complaints depending upon the facts of the complaint. 
The Department will continue to use appropriate means to educate the 
public about their rights and

[[Page 78087]]

how to file a complaint under the provider conscience regulation.
    The Department agrees that it will be important to ensure that the 
regulated entities and their employees are aware that the EEOC retains 
its primary jurisdiction in the area of enforcing protections under 
Title VII prohibiting employment discrimination based on religion. The 
Department will explore all avenues available, in coordination with the 
EEOC, for increasing public awareness of both health care conscience 
protection laws and Title VII's protections against employment 
discrimination based on religion. Where there are overlapping interests 
between the EEOC and the Department with respect to enforcement of 
protections against religious discrimination in employment, the EEOC 
and OCR roles and responsibilities are set forth in a federal 
regulation which has been in effect for 25 years, 29 CFR part 1691, 48 
FR 3574 (January 25, 1983) (as amended) (Procedures for Complaints of 
Employment Discrimination filed against Recipients of Federal Financial 
Assistance). This regulation provides for coordination between EEOC and 
OCR for review, investigation, and resolution of certain overlapping 
employment discrimination complaints, including those based on 
religion.
    Comment: Several Comments questioned the authority of the Secretary 
to issue this regulation. They pointed out that several of the 
statutory provisions such as the Church amendments lacked an explicit 
delegation of rulemaking authority to the Department. Several of these 
Commentators also stated the ``housekeeping statute,'' 5 U.S.C. 301, 
does not authorize the Department to promulgate standards for entities 
outside the agency, and that this rule is, therefore, ultra vires.
    Response: The Supreme Court has recognized the best, but not only, 
means by which an agency may promulgate binding legislative rules is 
through the issuance of regulations through notice and Comment 
rulemaking pursuant to delegated rulemaking authority. United States v. 
Mead, 533 U.S. 218 (2000). The Court has also found Chevron deference 
applicable where an agency has considerable expertise over a complex 
area and has given the issue careful consideration. Barnhart v. Walton, 
535 U.S. 212 (2002); Chevron U.S.A. Inc. v. Natural Resources Defense 
Council, Inc., 467 U.S. 837 (1984). Lower courts have also recognized 
binding deference to the Department in determining whether recipients 
of federal funds are complying with myriad federal requirements. 
Pharmaceutical Manfs. v. Thompson, 362 F.3d 817 (DC Cir. 2004). All 
these deference factors are applicable here, and in addition to the 
notice and Comment the Secretary has conducted here.
    Regardless of the Department's authority to promulgate legislative 
rules in this instance, it is well settled in case law that every 
agency has the inherent authority to issue interpretive rules and rules 
of agency practice and procedure. Pierce, Administrative Law at 306 
(4th ed. 2002). The compliance requirements set forth in this rule do 
not substantively alter or amend the obligations of the respective 
statutes. JEM Broadcasting v. FCC, 22 F3d 320 (DC Cir. 1994). While 
specific certification of compliance for the health care conscience 
protection laws is new, recipients of federal funding have long 
certified compliance with other applicable federal laws, including 
civil rights laws. While this needed change in procedures may prompt a 
minor increase in the costs of compliance for some entities, that does 
not alter the procedural nature of the rule. Hurson v. Glickman, 229 
F3d 277 (DC Cir. 2000).
    Furthermore, provisions of the rule which do no more than define 
terms are reasonably drawn from the existing statutes. Hoctor v. Dept. 
of Agriculture, 82 F3d 165 (7th Cir. 1996). Particularly as Congress 
intended the conscience protections to apply broadly across 
institutions and individuals, the Department has ample authority to 
issue these interpretive provisions.
    Comment: Several Comments raised the question of how this 
regulation may conflict with rules governing other Department programs. 
Some expressed concerns that the rule was inconsistent with program 
requirements of the Medicaid, Community Health Center, and Title X 
Family Planning programs, as well as the treatment requirements under 
the Emergency Medical Training and Active Labor Act (EMTALA). 
Specifically, Comments assert that this regulation is inconsistent with 
the requirement that institutions provide care in an emergency, a 
requirement that includes no exception for religious or moral 
objections to the needed service, and that the regulatory requirements 
for family planning clinics under Title X of the Public Health Service 
Act require Title X projects to offer pregnant women non-directive 
counseling, and referrals upon request for prenatal care and delivery, 
infant care, foster care or adoption, and abortion.
    Response: The Department does not operate its programs in conflict 
with the existing federal protections being further implemented by this 
rule. The Department believes that many Commenters are confused as to 
the programmatic requirements of various Departmental programs, and 
suggests that concerned parties seek clarification from individual 
program offices as appropriate. Similarly, the Department believes that 
Commenters mistakenly confuse certain legal requirements on 
institutions or health care entities as requirements on individual 
providers. With respect to emergency treatment, the obligations of 
EMTALA are imposed on hospital under 1867 of the Social Security Act 
only if they elect to operate an emergency room and are also limited to 
the capabilities of the particular hospital. The requirement under 
EMTALA that such hospitals treat and stabilize patients who present in 
an emergency is not in conflict with the Church Amendments' requirement 
that certain recipients of Department funds not force any individual to 
participate in a health service program that they object to based on a 
religious belief or moral conviction. While this and other hypothetical 
situations were raised in the Comments, the Department is not aware of 
any instance where a facility required to provide emergency care under 
EMTALA was unable to do so because its entire staff objected to the 
service on religious or moral grounds. With regards to the Title X 
program, Commenters are correct that the current regulatory requirement 
that grantees must provide counseling and referrals for abortion upon 
request (42 CFR 59.5(a)(5)) is inconsistent with the health care 
provider conscience protection statutory provisions and this 
regulation. The Office of Population Affairs, which administers the 
Title X program, is aware of this conflict with the statutory 
requirements and, as such, would not enforce this Title X regulatory 
requirement on objecting grantees or applicants.
    Comment: Multiple Comments questioned the balance between 
provisions in the Department's proposed rule and requested 
clarification on EMTALA requirements and how they will be upheld if the 
Department's proposed rule is promulgated.
    Response: The Department notes that this Comment would only be 
relevant where a hospital, as opposed to an individual, has an 
objection to performing abortions that are necessary to stabilize the 
mother, as that term has been interpreted in the context of EMTALA. The 
Department is unaware of any hospital that has such a policy. 
Furthermore, the laws this regulation supports have existed alongside

[[Page 78088]]

EMTALA for many years. Thus, we do not anticipate any actual conflict 
between EMTALA and this regulation.
    Comment: Some Comments expressed concern that this rule could 
interfere with existing state laws that regulate contraceptive coverage 
mandates in insurance policies, access to emergency contraception, and 
access to birth control at pharmacies. Commenters were also concerned 
that this regulation would impact a State's ability to enforce these 
laws and upset the balance that state and local laws already strike 
between the religious freedom of health care providers and a patient's 
need to access health care services.
    Response: As mentioned above, this rule was issued to help define 
the rights and responsibilities created by the existing federal health 
care provider conscience protection provisions, clarify the scope of 
the existing protections, require certain recipients of Department 
funds to certify compliance with these requirements, and define certain 
terms for the purposes of this rule. This rule does not change federal 
policy regarding the conscience rights of health care providers, or 
create new rights, but simply seeks to ensure that recipients of 
Department funds are aware of the existing conditions that apply to the 
receipt of these funds. As such, States should already be aware of 
these existing protections, and should ensure that they do not take 
actions that would violate these established federal protections. By 
accepting federal funds, States accept the conditions that the Congress 
has imposed on the receipt of those funds. In this case, Congress has 
seen fit to include broad conscience protections for health care 
entities that apply to a wide array of Department activities. As this 
rule implements existing law, if States wish to adopt or enforce 
policies that seek to ensure that patients have proper access to health 
care services, they would be expected to do so, but they should avoid 
policies that interfere with federally protected rights, or risk the 
loss of federal funds. While the Department is aware that some States 
may have laws that, if enforced, depending on the factual 
circumstances, might violate these federally protected rights, the 
Department is not aware of any particular instance where a State has 
done so in an inappropriate fashion. The Department's objective is to 
protect the conscience rights established in federal law, not to 
penalize States that adopt laws that, if enforced against an objecting 
individual or entity, could violate federal law. The Department is 
committed to working cooperatively with States to help ensure that they 
do not violate the federal protections.
    Comment: Several Comments claimed that the proposed rule is covered 
under existing federal laws, which makes the new proposed rule 
unnecessary.
    Response: The Department agrees that the provider conscience 
regulation's purpose is to implement existing federal laws by providing 
definitions to clarify the scope of those laws and to adopt 
certification mechanisms that will be used to increase awareness of, 
and compliance with, those laws. For reasons stated above, the 
Department disagrees that the rule is unnecessary.
    Comment: Several Comments noted that the rule supports the First 
Amendment right of freedom of religion.
    Response: The Department agrees. It is clear that Congress intended 
these statutes--the Church Amendment in particular--to further protect, 
in part, the First Amendment right to free exercise of one's religion 
in the context of healthcare provided by recipients of Departmental 
funds.
    Comment: Commenters claimed that the rule, if promulgated, would 
violate the ``constitutionally protected right to choose.''
    Response: We disagree. The Supreme Court has read the Constitution 
to include rights to privacy and bodily integrity broad enough to 
protect a woman's choice to procure an abortion. The case law 
enshrining this interpretation of the Constitution does not create or 
identify a corresponding duty on the part of any provider to be 
involved in the procedure in any way. In contrast, many protections, 
including principles established in court cases \4\ and ethical 
principles found in State and federal laws,\5\ are in place to ensure 
that no such duty is imposed on providers. The regulations implementing 
the Church Amendments, PHS Act Sec.  245, and the Weldon Amendment 
merely interpret these federal health care conscience protection 
provisions and encourage compliance.
---------------------------------------------------------------------------

    \4\ ``If [a] hospital's refusal to perform sterilization [or, by 
implication, abortion] infringes upon any constitutionally 
cognizable right to privacy, such infringement is outweighed by the 
need to protect the freedom of religion of denominational hospitals 
`with religious or moral scruples against sterilizations and 
abortions.' '' Taylor v. St. Vincent's Hospital, 523 F.2d 75, 77 
(9th Cir. 1975) (citations omitted).
    \5\ See, e.g., S.D. Codified Laws Sec.  36-11-70 (2003); Miss. 
Code Ann. Sec.  41-107-5 (2004).
---------------------------------------------------------------------------

    Comment: Comments stated that Congress upheld the access-to-care 
rights of pregnant women in the Education Appropriations Act beginning 
in 1997. The Comments declared that the proposed rule would contradict 
42 CFR 59.5(a)(5), which states women are to receive ``neutral, factual 
information and nondirective counseling, and referral upon request,'' 
regarding prenatal care and delivery, as well as adoption and 
termination options.
    Response: The Department is unsure which provision in the Education 
Appropriations Act the Commenter was referencing, and cannot respond 
except to say that we are unaware of any federal law that imposes a 
positive duty on doctors to provide services to which the provider 
objects.
    This rule is consistent with 42 CFR 59.5 with respect to an 
individual provider's right to refuse to counsel or refer for abortion, 
as explained in the preamble to the final rule that promulgated that 
requirement:

    The corollary suggestion, that the requirement to provide 
options counseling should not apply to employees of a grantee who 
object to providing such counseling on moral or religious grounds, 
is likewise rejected. In addition to the foregoing considerations, 
such a requirement is not necessary: Under 42 U.S.C. 300a-7(d), 
grantees may not require individual employees who have such 
objections to provide such counseling. However, in such cases the 
grantees must make other arrangements to ensure that the service is 
available to Title X clients who desire it. 65 FR 41270, 41274 
(2000).

    As is always the case, requirements and prohibitions contained in a 
regulation cannot be enforced in derogation of conflicting statutes. 
Thus, under section 245 of the Public Health Service Act and the Weldon 
Amendment, the Department cannot and does not enforce 42 CFR 59.5(a)(5) 
against an otherwise eligible grantee or applicant who objects to the 
requirement to counsel on or refer for, abortion. See Nat'l Family 
Planning & Reprod. Health Ass'n v. Gonzales, 468 F.3d 826, 828 (DC Cir. 
2006) (``* * * the government notes, and plaintiff doesn't contest, 
that in the event of conflict the regulation must yield to a valid 
statute.'').
    Comment: A number of Comments stated that the proposed rule is 
unnecessary in part because of the National Research Act, which created 
protection within biomedical and behavioral research organizations and 
formed a commission to ensure these rights are protected.
    Response: The Department disagrees. The Department has identified 
several instances that suggest that providers, employers, and employees 
are unaware of the protections found in federal law. Hundreds of 
Comments have confirmed this lack of awareness. This rule is an

[[Page 78089]]

important step in ensuring knowledge of, and compliance with, the 
provider conscience provisions found in these statutes.
    Comment: One Commenter argued that the regulation was needed and 
there are no court rulings, including Roe v. Wade and Planned 
Parenthood v. Casey, 505 U.S. 833 (1992), that compel an individual or 
institutional health care provider to participate in the provision of 
abortions, so the regulation does not contradict the cases.
    Response: The Department agrees. Although these cases interpret the 
Constitution to include a right to abortion, they do not create an 
affirmative duty on the part of any provider to perform or participate 
in the provision of such an abortion.
    Comment: A Commenter cited the Supreme Court case of Griswold v. 
Connecticut, 381 U.S. 479 (1965), that addressed the privacy of a 
married couple to engage in the use of birth control versus the State's 
law which declared contraception illegal.
    Response: The Department notes that the Supreme Court in Griswold 
affirmed a married couple's right to use contraception as against a 
State law that prohibited such access. It did not impose upon any 
provider an affirmative duty to prescribe or dispense contraception.
    Comment: One Commenter stated that Shelton v. University of 
Medicine and Dentistry of New Jersey, 223 F.3d 220 (3d Cir. 2000), 
clearly shows that in times of emergency professional ethical 
obligations to care for the sick and injured outweigh their conscience.
    Response: The Department disagrees with this reading of Shelton. 
The sole issue in that case was ``whether a state hospital reasonably 
accommodated the religious beliefs and practices of a staff nurse who 
refused to participate in what she believed to be abortions.'' Shelton 
v. University of Med. & Dentistry, 223 F.3d 220, 222 (3d Cir. 2000). 
Her employer offered her a lateral transfer, which she refused. The 
court held that this offer of a lateral transfer was a reasonable 
accommodation under the Civil Rights Act of 1964. The court said 
nothing of ethical obligations to care for the sick and injured 
outweighing conscience.
    Comment: One Commenter argued that the rule does not make clear 
that the providers' religious objection has to be to the activity or 
procedure, not to the patient and stated that in a recent decision 
(North Coast Women's Care Medical Group v. Ben[iacute]tez, 44 Cal. 4th 
1145 (2008)), the California Supreme Court ruled that doctors are 
barred from refusing medical care to homosexuals based on the doctors' 
religious beliefs about homosexuals.
    Response: In Ben[iacute]tez, the California Supreme Court was 
interpreting State, not federal, law. The Court's analysis is 
inapplicable to this situation. Further, the Department believes the 
statutes and this rule are sufficiently clear as to applicability.
    Comment: One Commenter suggested that the proposed rule violates a 
White House directive that executive departments and agencies submit 
all proposed rules by June 1, 2008, except in ``extraordinary 
circumstances.'' The Commenter stated the Department should explain 
those extraordinary circumstances or withdraw its proposal.
    Response: The memorandum issued by the Chief of Staff to the 
President was solely for purposes of management and coordination of the 
Executive Branch, conferred no rights on anyone outside the Executive 
Branch, did not create any legal requirements, and by its own terms 
authorized the exercise of discretion and exceptions to timing 
guidelines where appropriate. The Department has solicited and 
carefully evaluated public Comment as required by the Administrative 
Procedure Act. Nothing in applicable law precluded issuance of the 
proposed rule, just as nothing in applicable law precludes the issuance 
of this final rule.
    Comment: Some Comments requested that the 30-day Comment period be 
extended.
    Response: We decline to extend the 30-day Comment period. The 
purpose of extending the Comment period would be to provide additional 
opportunity to Comment on the proposed rule. We note that, as 
demonstrated by the volume of Comments received by the Department, 
Commenters had ample opportunity to submit Comments and did so. The 
Department received Comments discussing a wide range of issues, 
including potential impact of the proposed rule, from stakeholders 
including hospitals, health care providers, professional associations, 
trade groups, advocacy organizations, private citizens, and others. The 
Department has had sufficient opportunity to weigh the issues posed by 
public Comments, including the impact of the proposed rule and its 
interaction with State and federal laws, and has taken such Comments 
into account in issuing this final rule.
    Comment: One Commenter stated that the interests protected in the 
regulation are only specific concerns of providers in particular 
situations or locations, and the only thing needed to remedy the 
conflict is to change the situation or location to accommodate the 
employee.
    Response: The Department agrees that employers should strive for 
accommodation of religious beliefs, moral convictions, or convictions 
against involvement in abortions or sterilizations. However, the 
Department believes that regulations are necessary to ensure that 
employers opt to accommodate their employees' objections rather than to 
engage in intimidation or discrimination.
    Comment: One Comment asserted that HHS's concern about the 
development of an environment in which individuals from diverse 
backgrounds are discouraged from entering health care professions 
contrasts with the accreditation requirements of The Liaison Committee 
on Medical Education (LCME) and The Accreditation Council for Graduate 
Medical Education (ACGME). That is, these organizations have standards 
that are ``designed to ensure that the education of physicians provides 
an environment that embraces a diversity of views and values for both 
health care providers and patients.''
    Response: The Department disagrees. Although the requirements are 
certainly useful as future physicians are educated, the Department 
thinks it would be uncontroversial to suggest that over time, as 
physicians and other professionals are trained and begin practicing 
medicine, their attitudes and demeanor may change. Thus, these 
regulations are needed to protect against coercion and discrimination 
across the span of a professional's education and career.
    Comment: One Commenter claimed that the regulation would require 
the American Medical Association to rewrite its code of ethics.
    Response: As noted before, this regulation simply enforces federal 
law. The American Medical Association code of ethics--which, in any 
event, does not appear to conflict with federal law--is not binding 
law, so it may not matter if there is a conflict. Insofar as problems 
may arise as a result of conflict between any code of ethics and 
federal law, the proper solution is to rewrite the relevant code of 
ethics.
    Comment: One Commenter recommended that the Department set up a 
process by which providers ensure patients receive care from another 
provider when they have objections to the requested procedure.
    Response: While the Department suspects that such referrals may be 
how many providers will handle these types of situations, it declines 
to impose such a requirement in the rule, since such a requirement 
would constitute ``making arrangements for'', ``referring for'', or

[[Page 78090]]

``assisting in the performance'' of an abortion or other objectionable 
procedure in violation of the health care provider conscience 
protection statutes.

III. Legal Authority

    On the basis of the following statutory authority, the Secretary 
promulgates these regulations, requiring certification of compliance 
with anti-discrimination statutes.
    5 U.S.C. 301 empowers the head of an Executive department to 
prescribe regulations ``for the government of his department, the 
conduct of its employees, the distribution and performance of its 
business, and the custody, use, and preservation of its records, 
papers, and property.''
    The Church Amendments, 42 U.S.C. 300a-7 (2000), prohibit recipients 
of Department funding under the PHS Act and several other statutes from 
discriminating against employees and others who participate in health 
service programs or research activities funded in whole or part by the 
Department who refuse to perform certain medical services, including 
sterilization, abortion, or research activities because of religious or 
moral beliefs. Specifically, section 300a-7(c)(1)(A) and (B) provides 
that recipients may not discriminate in the employment of or the 
extension of staff privileges to any health care professional because 
he refused, because of his religious beliefs or moral convictions, to 
perform or assist in the performance of any sterilization or abortion 
procedures. Section 300a-7(d) provides that no individual shall be 
required to perform or assist in the performance of any health service 
program or research activity funded in whole or part by the Department 
contrary to his religious beliefs or moral convictions.\6\
---------------------------------------------------------------------------

    \6\ Section 300a-7(c)(1) provides that ``[n]o entity which 
receives a grant, contract, loan, or loan guarantee under the [Act] 
* * * may (A) discriminate in the employment, promotion, or 
termination of employment of any physician or other health care 
personnel, or (B) * * * in the extension of staff or other 
privileges to any physician or other health care personnel * * * 
because he refused to perform or assist in the performance of * * * 
[an] abortion'' on the grounds that doing so ``would be contrary to 
his religious beliefs or moral convictions.'' 42 U.S.C. 300a-
7(c)(1). Section 300a-7(c)(2) provides that ``[n]o entity which 
receives * * * a grant or contract for biomedical or behavioral 
research under any program administered by [HHS]'' may discriminate 
in the employment of or the extension of staff privileges to any 
health care professional ``because he refused to perform or assist 
in the performance of'' ``any lawful health service'' based on 
religious belief or moral conviction. 42 U.S.C. 300a-7(c)(2). 
Section 300a-7(d) provides that ``[n]o individual [may] be required 
to perform or assist in the performance of any part of a health 
service program * * * funded in whole or in part under a program 
administered by the Secretary of Health and Human Services'' if 
doing so ``would be contrary to his religious beliefs or moral 
convictions.'' 42 U.S.C. 300a-7(d). Section 300a-7(e) prohibits any 
entity that receives funding under the PHS Act from denying 
admission to, or otherwise discriminating against, ``any applicant 
(including for internships and residencies) for training or study 
because of the applicant's reluctance * * * to counsel, suggest, 
recommend, assist, or in any way participate in the performance of 
abortions * * * contrary to or consistent with the applicant's 
religious beliefs or moral convictions.'' 42 U.S.C. 300a-7(e). In 
addition, section 300a-7(b) provides in part that ``[t]he receipt of 
any grant, contract, loan, or loan guarantee under the [PHS Act] * * 
* by any individual or entity does not authorize any court or any 
public official or other public authority to require'' (1) the 
individual to perform or assist in an abortion if it would be 
contrary to his/her religious beliefs or moral convictions; or (2) 
the entity to make its facilities available for abortions, if the 
performance of abortions in the facilities is prohibited by the 
entity on the basis of religious beliefs or moral convictions, or 
provide personnel for the performance of abortions if it would be 
contrary to the religious beliefs or moral convictions of such 
personnel. 42 U.S.C. 300a-7(b).
---------------------------------------------------------------------------

    PHS Act Sec.  245, 42 U.S.C. 238n (1996), prohibits the Federal 
government and any State or local government that receives federal 
financial assistance from discriminating against any health care entity 
(including both individual and institutional providers) on the basis 
that, among other things, the entity refuses to (1) receive training in 
abortion; (2) provide abortion training; (3) perform abortions; (4) 
provide referral for such abortions; and (5) provide referrals for 
abortion training. 42 U.S.C. 238n(a).
    The Weldon Amendment, Consolidated Appropriations Act, 2008, Public 
Law 110-161, Sec.  508(d), 121 Stat. 1844, 2209 (2008), prohibits a 
federal agency or program, or any State or local government from 
receiving Department funds 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.
    These statutory provisions require that the Department and 
recipients of Department funds refrain from discriminating against 
institutional and individual health care entities for their 
participation or refusal to participate in certain medical services or 
research activities funded by the federal government. The Department 
has authority to promulgate regulations to enforce these prohibitions. 
Finally, the Department also has the legal authority to require that 
recipients certify their compliance with these proposed requirements 
and to require their sub-recipients to likewise certify their 
compliance with these proposed requirements.
    We respond to the Comment on the Department's legal authority to 
promulgate these regulations in section H (General Comments) of the 
Comments section above.

IV. Section-by-Section Description of the Final Rule

Section 88.1 Purpose

    Proposed Rule: In the proposed rule, the ``Purpose'' section set 
forth the objective that this final rule provides for the 
implementation and enforcement of federal nondiscrimination statutes 
protecting the conscience rights of health care entities. It also 
states that the statutory provisions and regulations contained in this 
Part are to be interpreted and implemented broadly to effectuate these 
protections.
    The Department received no Comments on this section.
    Final Rule: The Department adopts this provision as recommended in 
the proposed rule without modification.

Section 88.2 Definitions

Assist in the Performance
    Proposed Rule: The Department, in considering how to interpret the 
term ``assist in the performance,'' sought to provide broad protection 
for individuals. At the same time, the Department sought to guard 
against potential abuses of these protections by limiting the 
definition of ``assist in the performance'' to only those individuals 
who have a reasonable connection to the procedure, health service or 
health service program, or research activity to which they object.
    Therefore, the Department proposed to interpret this term broadly, 
as encompassing individuals who are members of the workforce of the 
Department-funded entity performing the objectionable procedure. When 
applying the term ``assist in the performance'' to members of an 
entity's workforce, the Department proposed that the term be limited to 
participation in any activity with a reasonable connection to the 
objectionable procedure, including referrals, training, and other 
arrangements for the procedure, health service, or research activity. 
For example, an operating room nurse would assist in the performance of 
surgical procedures; an employee whose task it is to clean the 
instruments used in a particular procedure would also be considered to 
assist in the performance of the particular procedure under the 
proposed rule.
    The Department responds to Comments on the proposed definition of 
this term above.

[[Page 78091]]

    Final Rule: The Department adopts the above definition as proposed.
Health Care Entity/Entity
    Proposed Rule: While both PHS Act Sec.  245 and the Weldon 
Amendment provide examples of specific types of protected individuals 
and health care organizations, neither statute provides an exhaustive 
list of such health care entities. PHS Act Sec.  245 defines ``health 
care entity'' as ``includ[ing] an individual physician, a postgraduate 
physician training program, and a participant in a program of training 
in the health professions.'' As a matter of statutory construction as 
well as long-standing Departmental interpretation, the definition of 
``health care entity'' in PHS Act Sec.  245 also encompasses 
institutional entities, such as hospitals and other entities. The 
Weldon Amendment defines the term ``health care entity'' as 
``includ[ing] 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.'' The Church Amendment 
does not define the term ``entity,'' and does not use the term ``health 
care entity.''
    In keeping with the definitions in PHS Act Sec.  245 and the Weldon 
Amendment, the Department proposed to define ``health care entity'' to 
include the specifically mentioned types of individuals and 
organizations from the two statutes, as well as other types of entities 
referenced in the Church Amendments.
    The Department responds to Comments on the proposed definition of 
this term above.
    Final Rule: The Department adopts the proposed definition without 
modification. It is important to note that the Department does not 
intend for this to be a comprehensive list of relevant types of 
individuals and organizations for purposes of the regulation, but 
merely a list of examples.
Health Service/Health Service Program
    Proposed Rule: One of the provisions in the Church Amendments uses 
the term ``health service,'' another uses the term ``health service 
program.'' The Church Amendments do not define these terms, nor does 
the Public Health Service Act define ``health service program.'' In 
developing an appropriate definition for ``health service program,'' 
the proposed rule looked at the Social Security Act. Section 
1128B(f)(1) of the Social Security Act, 42 U.S.C. 1320a-7b(f)(1), 
defines a similar term, ``federal health care program'', as ``any plan 
or program that provides health benefits, whether directly, through 
insurance, or otherwise, which is funded directly, in whole or in part, 
by the United States Government.''
    Building on this broad definition, it was proposed that the term 
``health service program'' should be understood to include an activity 
related in any way to providing medicine, health care, or any other 
service related to health or wellness, including programs where the 
Department provides care directly (e.g., Indian Health Service); 
programs where grants pay for the provision of health services (e.g., 
Administration for Children and Families programs such as the 
Unaccompanied Refugee Minor and the Division of Unaccompanied Children 
Services programs and HRSA programs such as community health centers); 
programs where the Department reimburses another entity that provides 
care (e.g., Medicare); and health benefit programs where federal funds 
are used to provide access to health coverage (e.g., SCHIP, Medicaid, 
and Medicare Advantage).
    The Department responds to Comments on the proposed definition of 
this term above.
    Final Rule: Upon further reflection, the Department has determined 
that the meaning of the term ``health service'' is self-evident, and so 
we do not adopt a definition for ``health service'' in this final rule.
    Final Rule: The Department adopts the above definition without 
modification.
Individual
    Proposed Rule: For the purposes of the new proposed part, the 
proposed rule defined ``individual'' to mean a member of the workforce 
(see definition of ``workforce'' below) of an entity or health care 
entity. One conscience clause of the Church Amendments, 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 Secretary of Health, Education and Welfare 
[Secretary of Health and Human Services] 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.'' 
(Emphasis added.)
    The Department responds to Comments on the proposed definition of 
this term above.
    Final Rule: The Department adopts the above definition as proposed.
Instrument
    Proposed Rule: The proposed rule uses the term ``instrument'' to 
mean the variety of means by which the Department conveys funding and 
resources to organizations, including: grants, cooperative agreements, 
contracts, grants under a contract, and memoranda of understanding. The 
proposed definition of ``instrument'' was intended to include all means 
by which the Department conveys funding and resources.
    No Comments were received on the definition of this term.
    Final Rule: The Department adopts the above definition without 
modification.
Recipient
    Proposed Rule: The proposed rule defined this term to mean any 
entity that receives Department funds directly.
    The Department responds to Comments on the proposed definition of 
this term above.
    Final Rule: The Department adopts this definition as proposed.
Sub-recipient
    Proposed Rule: The proposed rule defined this term to mean any 
entity that receives Department funds indirectly through a recipient or 
sub-recipient.
    The Department responds to Comments on the proposed definition of 
this term above.
    Final Rule: The Department adopts this definition as proposed.
Workforce
    Proposed Rule: In the proposed rule we defined the term 
``workforce'' as including employees, volunteers, trainees, and other 
persons whose conduct, in the performance of work for an entity, is 
under the control or authority of such entity, whether or not they are 
paid by the Department-funded entity. The definition was drawn from the 
``Administrative Data Standards and Related Requirements'' rules 
implementing the Health Insurance Portability and Accountability Act 
(HIPAA), 45 CFR parts 160, 162, and 164 (2006) at 45 CFR 160.103. In 
keeping with this definition, persons and organizations under contract 
with an entity, if they are under the control or authority of the 
entity, would be considered members of the entity's workforce.
    The Department responds to Comments on the proposed definition of 
this term above.
    Final Rule: In response to public Comments on this issue, we have 
provided an exclusive definition of the

[[Page 78092]]

term ``workforce'' by changing ``includes'' to ``means'' in the 
definition. In defining both ``individual'' and ``workforce,'' the 
Department promulgates definitions that provide a reasonable scope for 
the natural persons protected by 42 U.S.C. 300a-7(d) and the 
corresponding provisions of these regulations. By limiting the scope of 
persons protected by these regulations to those who are under the 
control or authority of an entity that implements a health service 
program or research activity funded in whole or in part under a program 
administered by the Department, we provide the bright line necessary 
for Department-funded entities subject to the applicable Church 
Amendment provisions to set policies or otherwise take steps to secure 
conscience protections within the workplace and, thus, to comply with 
the Church Amendment and these regulations.
    As indicated in the proposed rule--and consistent with the scope of 
the Church Amendments, which include physicians and other health care 
providers that have privileges with an entity receiving funding from 
the Department--we intended the concept of ``workforce'' to include 
physicians and other health care providers who have privileges at the 
entity funded by the Department. After publication of the proposed 
rule, it came to the Department's attention that the language of the 
``workforce'' definition may not be clear on this issue. Accordingly, 
to ensure clarity on this point, we are revising the definition of 
``workforce'' by adding at the end ``or health care providers holding 
privileges with the entity''.

Section 88.3 Applicability

    Proposed Rule: The ``Applicability'' section of the proposed rule 
directs individuals and entities receiving funds from the Department to 
the appropriate sections of proposed section 88.4 that set forth the 
relevant requirements, drawn from the three statutes that form the 
basis of this regulation, that are applicable to them and also directed 
to the provisions regarding certifications that the various recipients 
of federal monies must provide.
    Final Rule: In this final rule, we have included a technical 
correction in section 88.3 clarifying that educational institutions, 
teaching hospitals, and programs for the training of health care 
professionals or health care workers shall comply with section 
88.4(c)(2), which prohibits discrimination against or denial of 
admission to applicants ``because of reluctance or willingness to 
counsel, suggest, recommend, assist, or in any way participate in the 
performance of abortions or sterilizations contrary to or consistent 
with the applicant's religious beliefs or moral convictions'' in 
accordance with PHS Act Sec.  245. 42 U.S.C. 300a-7(e). Apart from this 
change, we have adopted this provision as recommended in the proposed 
rule.

Section 88.4 Requirements and Prohibitions

    Proposed Rule: The ``Requirements and Prohibitions'' section in the 
proposed rule explains the obligations that the Church Amendments, PHS 
Act Sec.  245, and the Weldon Amendment impose on entities which 
receive funding from the Department, depending on the type of entity 
and the program or statute under which the funding is received. These 
provisions are taken from the relevant statutory language and make up 
the elements of the certification provided by the entities. The 
proposed rule states that we intend for the requirements and 
prohibitions to be interpreted using the definitions contained in 
section 88.2.
    Final Rule: The final rule adopts this provision without change.

Section 88.5 Written Certification of Compliance

    Proposed Rule: In the ``Written Certification of Compliance'' 
section of the proposed rule, the Department proposed to require 
certain recipients and sub-recipients of Department funds to certify 
compliance with the Church Amendments, PHS Act Sec.  245, and the 
Weldon Amendment, as applicable, and to provide for the affected 
recipients and sub-recipients requirements for collecting, maintaining, 
and submitting written certifications.
    We are concerned that there is a lack of knowledge on the part of 
States, local governments, and the health care industry of the rights 
of health care entities created by, and the corresponding obligations 
imposed on the recipients of certain federal funding by, the 
nondiscrimination provisions. Under the proposed rule, recipients of 
federal funds would be required to submit their certifications directly 
to the Department as part of the instrument or in a separate writing 
signed by the recipients' officer or other person authorized to bind 
the recipient. They would also be required to collect and maintain 
certifications by sub-recipients who receive Department funds through 
them.
    The proposed regulation would require that entities certify in 
writing that they will operate in compliance with the Church 
Amendments, PHS Act Sec.  245, and the Weldon Amendment as applicable. 
Certification provides a demonstrable way of ensuring that the 
recipients of such funding know of, and attest that they will comply 
with, the applicable nondiscrimination provisions. Sub-recipients of 
federal funds--entities that will receive federal funds indirectly 
through another entity (a recipient or other sub-recipient)--would be 
required to provide certification as set out in the ``Sub-recipient'' 
subsection of the ``Certification of Compliance'' section, and submit 
them to the recipients through which they receive Department funds for 
maintenance. Although it would be collected and maintained by the 
recipient, this certification by sub-recipients would be a 
certification addressed to the Department, not to the recipients 
collecting the certification. Recipients would be expected to comply 
with requirements for retention of and access to records set forth in 
45 CFR 74.53.
    While all recipients and sub-recipients of Department funds are 
required to comply with the Church Amendments, PHS Act Sec.  245, and 
the Weldon Amendment, as applicable, section 88.5(e), as proposed, 
would contain several important exceptions to the proposed requirement 
to provide the written certification, including individual physicians, 
physician offices, other health care practitioners, and other 
participants in Part B of the Medicare program; (2) physicians, 
physician offices, or other health care practitioners participating in 
Part C of the Medicare program, when such individuals or organizations 
are sub-recipients of Department funds through a Medicare Advantage 
plan; and (3) sub-recipients of State Medicaid programs (i.e., any 
entity that is paid for services by the State Medicaid program).
    While other providers participating in the Medicare program as well 
as State Medicaid programs would be required to submit written 
certification of compliance to the Department, the large number of 
entities included in the categories of providers listed above (e.g., 
individual physicians, physician offices, other health care 
practitioners, and sub-recipients of State Medicaid programs) would 
have posed significant implementation hurdles for Departmental 
components and programs. Furthermore, the Department believed that, due 
primarily to their generally smaller size, the excepted categories of 
recipients and sub-recipients of Department funds in the above 
categories would be less likely to encounter the types of issues sought 
to be addressed in this regulation.

[[Page 78093]]

However, we noted in the proposed rule that excepted providers may 
become subject to the proposed written certification requirement by 
receiving Department funds under a separate agency or program. For 
example, under the proposed rule, a physician office participating in 
Medicare Part B may become subject to the proposed written 
certification requirement by receiving Department funds to conduct 
clinical research. We noted, however, that the State Medicaid programs 
would be responsible for ensuring the compliance of their sub-
recipients as part of ensuring that the State Medicaid program is 
operated consistent with applicable nondiscrimination provisions.
    Final Rule: Partly in Response to suggestions received in Response 
to solicitation of public Comment on this issue (see the Department 
Responses to the Comments on the proposed certification requirement 
above), HHS has determined to make further exceptions to the 
certification requirements in section 88.5 in the final rule. 
Exceptions from the written certification requirement are included for 
Departmental grant programs whose purpose is unrelated to health care 
provision, including economic assistance, and which do not involve 
medical research or the involvement of health care providers, and which 
are unlikely to involve referral for provision of health care. These 
programs often involve funding to States and other governments for non-
health care purposes, and/or cash assistance or vouchers, rather than 
direct services by a funded entity, to individuals. These programs are 
unlikely to involve Department funds being used for medical research, 
the participation of health care providers or referral to health care 
providers. As a consequence, these programs are also unlikely to 
encounter the circumstances contemplated by this regulation, and 
therefore the assurance of compliance represented by a certification is 
not considered necessary by the Department for such programs. Programs 
excepted under this provision include certain current programs 
administered by the Administration for Children and Families, including 
Low-Income Home Energy Assistance Program, Assets for Independence, the 
Child Care and Development Fund, Job Opportunities for Low-Income 
Individuals, Mentoring Children of Prisoners, and programs overseen by 
the Office of Child Support Enforcement, as well as certain current 
programs administered by the Administration on Aging. Finally, an 
exception to the written certification requirement of section 88.5 has 
been included for Indian Tribes and Tribal Organizations when 
contracting with the Indian Health Service under the Indian Self-
Determination and Education Assistance Act.
    As stated in the proposed rule, individual Department components 
have been tasked with determining how best to implement the written 
certification requirements set out in this regulation in a way that 
ensures efficient program operation. To this end, Department components 
have been given discretion to phase in the written certification 
requirement by no later than the beginning of the next federal fiscal 
year following the effective date of the regulation.
    Finally, we have reorganized the wording of the written 
certifications in section 88.5 for purposes of clarity and to more 
closely track the language of the health care conscience protection 
laws. Recipients are expected to comply with the records retention and 
access requirements in 45 CFR 74.53, 45 CFR 92.42, 45 CFR 96.30, and 
any other applicable requirements.

Section 88.6 Complaint Handling and Investigating

    Proposed Rule: This section did not appear in the proposed rule.
    Final Rule: We have included a new section 88.6 to clarify, as was 
stated in the preamble to the proposed rule, that the HHS Office for 
Civil Rights (OCR) has been designated to receive complaints of 
discrimination and coercion based on the health care conscience 
protection statutes and this regulation. OCR will coordinate handling 
of complaints with the staff of the Departmental programs from which 
the entity, with respect to which a complaint has been filed, receives 
funding (i.e., Department funding component).

IV. Analysis of Economic Impacts

Executive Order 12866--Regulatory Planning and Review

    HHS has examined the economic implications of this final 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 sector of the economy in a material way, 
adversely affecting competition, or adversely affecting jobs. A 
regulation is also considered a significant regulatory action if it 
raises novel legal or policy issues. HHS has determined that, although 
this final rule is not economically significant, it is a significant 
regulatory action as defined by Executive Order 12866.
    Comment: One Comment stated that HHS did not provide an adequate 
cost-benefit analysis as required by E.O. 12866. The Comment pointed 
out that the Department concluded that the rule is a significant 
regulatory action but did not undertake a more formal analysis.
    Response: HHS disagrees. Our conclusion, based on the analysis of 
impacts of the proposed rule, was that the rule was not economically 
significant. Therefore, the assessment of potential costs and benefits 
provided was sufficient to meet the requirements of the Executive 
Order.
    Comment: Two Comments stated HHS's analysis was inadequate in that 
it did not consider the costs of additional health care or other 
impacts on patients and employers because various definitions had been 
broadened. Another Comment stated that HHS did not asses the effects on 
public health resulting from a decrease in access to care.
    Response: HHS disagrees. As stated previously, the Department does 
not agree that the interpretation of the terms used in this rule have 
been broadened or that the scope of the laws were expanded. Nor does 
HHS agree that this rule would cause changes in staffing or other 
processes beyond those changes entities have already incurred in order 
to comply with existing statutes. This final rule does not limit 
patient access to health care, but rather implements existing federal 
laws. Thus, we have not changed our analysis in Response to this 
Comment.
    An underlying assumption of this regulation is that the health care 
industry, including entities receiving Department funds, will benefit 
from more diverse and inclusive workforces by informing health care 
workers of their rights and fostering an environment in which 
individuals from many different faiths and philosophical backgrounds 
are encouraged to participate. As a result, we cannot accurately 
account for all of the regulation's future benefits, but the Department 
is confident that the future benefits will exceed the costs of 
complying with the regulation.

[[Page 78094]]

    Comment: One Comment suggested that the number of affected entities 
suggests that the benefits will not exceed the costs of complying with 
the regulation. The Commenter provided no clarification and no data to 
support this statement.
    Response: The Department has not revised its analysis in Response 
to this Comment.
    The statutes mandating the requirements for protecting health care 
workers as discussed in this rule have been in effect for a number of 
years. Therefore, the regulatory burden associated with this rule is 
largely associated with the incremental costs of certifying to the 
Federal government and the cost of collecting and maintaining records 
of certification statements from sub-recipients. We estimate the 
universe and number of entities that would be required to certify to be 
571,947 (see Table I). This estimate has been revised from the proposal 
to reflect new exceptions to the certification requirement for 
recipients of ACF, AOA, and IHS funds. We do not distinguish between 
recipients and sub-recipients of HHS funding. Each entity could be a 
recipient, a sub-recipient, or both.

                        Table--Affected Entities
------------------------------------------------------------------------
                                                            Number of
                  Health care entity                        entities
------------------------------------------------------------------------
Hospitals (less than 100 beds) \7\....................             2,403
Hospitals (100-200 beds) \17\.........................             1,129
Hospitals (200-500 beds) \17\.........................             1,160
Hospitals (more than 500 beds) \17\...................               244
Nursing Homes (less than 50 beds) \8\.................             2,388
Nursing Homes (50-99 beds) \18\.......................             5,819
Nursing Homes (99-199 beds) \18\......................             6,877
Nursing Homes (more than 200 beds) \18\...............             1,037
Physicians Offices \9\................................           234,200
Offices of Other Health Care Practitioners \18 10\....           115,378
Outpatient Care Centers \11 19\.......................            26,901
Medical and Diagnostic Laboratories \19\..............            11,856
Home Health Care Services \19\........................            20,184
Pharmacies (chain and independent) \12\...............            58,109
Dental Schools \13\...................................                56
Medical Schools (Allopathic) \17\.....................               125
Medical Schools (Osteopathic) \17\....................                20
Nursing Schools (Licensed practical) \14\.............             1,138
Nursing Schools (Baccalaureate) \22\..................               550
Nursing Schools (Associate degree) \22\...............               885
Nursing Schools (Diploma) \22\........................                78
Occupational Therapy Schools \17\.....................               142
Optometry Schools \17\................................                17
Pharmacy Schools \17\.................................                92
Podiatry Schools \17\.................................                 7
Public Health Schools \17\............................                37
Residency Programs (accredited) \15\..................             8,494
Health Insurance Carriers and 3rd-Party Administrators             4,578
 \16\.................................................
Grant awards \17\.....................................            63,741
Contractors \18\......................................             4,245
State and territorial governments.....................                57
                                                       -----------------
    Total.............................................           571,947
------------------------------------------------------------------------

    The Department envisions three sub-categories of potential costs 
for recipients and sub-recipients of Department funds: (1) Direct costs 
associated with the act of certification; (2) Direct costs associated 
with collecting and maintaining certifications made by sub-recipients; 
and (3) indirect costs associated with certification.
---------------------------------------------------------------------------

    \7\ Health, United States, 2007. U.S. Dept. of Health and Human 
Services, Centers for Disease Control and Prevention, National 
Center for Health Statistics. Nov. 2007.
    \8\ Nursing Home Data Compendium, 2007 edition. U.S. Dept. of 
Health and Human Services, Centers for Medicaid and Medicare 
Services.
    \9\ See HIPAA Administrative Simplification NPRM: Modification 
to Medical Data Code Set Standards Toto Adopt ICD-10-CM and ICD-10-
PCS; Proposed Rule, 73 FR 49796-49872, August 22, 2008.
    \10\ From the NAICS Code 6213--Office of Other Health Care 
Practitioners (including Chiropractors, Optometrists, non-Physician 
Mental Health Practitioners, Physical Occupational and Speech 
Therapists, Podiatrists, and all other Miscellaneous Health Care 
Practitioners.
    \11\ From the NAICS Code 6214--Outpatient Care Centers 
(including Family Planning Centers, Outpatient Mental Health and 
Substance Abuse Centers, Other Outpatient Care Centers, HMO Medical 
Centers, Kidney Dialysis Centers, Freestanding Ambulatory Surgical 
and Emergency Centers, and all Other Outpatient Care Centers.
    \12\ 2005 NCPA-Pfizer Digest: Total, Prescription Sales Increase 
At Nation's Independent Pharmacies. National Community Pharmacies 
Association Press Release, May 12, 2005.
    \13\ Dental Education At-A-Glance, 2004. American Dental 
Education Association. Available at: http://www.adea.org/CEPR/Documents/2004_Dental_Ed_At_A_Glance.pdf.
    \14\ National Center for Health Workforce Analysis: U.S. Health 
Workforce Personnel Factbook. U.S. Dept. of Health and Human 
Services, Health Resources and Services Administration.
    \15\ Number of Accredited Programs by Academic Year (7/1/2007-6/
30/2008). Accreditation Council for Graduate Medical Education. 
Available at: http://www.acgme.org/adspublic/reports/accredited_programs.asp.
    \16\ U.S. Department of Labor, Bureau of Labor Statistics, 
National Occupational Employment and Wage Estimates, May 2007.
    \17\ HHS Grants Statistics, 2007. Available at http://www.hhs.gov/grantsnet.
    \18\ General Services Administration (estimated).
---------------------------------------------------------------------------

    In the analysis to the proposed rule, we explained that indirect 
costs associated with the certification requirement might include costs 
for such actions as staffing/scheduling changes and internal reviews to 
assess compliance. We further explained that there is insufficient data 
to estimate the number of funding recipients not

[[Page 78095]]

currently compliant with the Church Amendments, PHS Act Sec.  245, or 
the Weldon Amendment. We received no Comments indicating that there 
were any funding recipients not currently compliant. Therefore, we 
continue to assume that, because together these three federal statutes 
have been in existence for many years, the incremental indirect costs 
of certification will be minimal for Department funding recipients.
    Comment: Four Commenters argued against our administrative cost 
estimates associated with the certification process. These Comments 
stated that the analysis of the proposed rule did not sufficiently 
account for the cost of collecting, maintaining, and submitting written 
certifications. However, the Comments provided no new information or 
data.
    Response: HHS disagrees. In determining the costs associated with 
collecting and maintaining the certification, we reviewed the analysis 
and regulatory costs associated with or conducted for several other 
similar certification requirements for HHS programs. The Comments did 
not provide any new information or data nor did they suggest any 
activities for which we did not already account in the analysis. Thus, 
we have not changed the analysis in Response to these Comments.
    The direct cost of certification is the cost of reviewing the 
certification language, reviewing relevant entity policies and 
procedures, and reviewing files before signing. We estimate that each 
of the 571,947 entities will spend an average of 30 minutes on these 
activities. Although some entities may need to sign a certification 
statement more than once, we assume that the entity will only carefully 
review the language, procedures and their files before signing the 
initial statement each year. We assume the cost of signing subsequent 
statements to be small. Some existing HHS certification forms specify 
the certification statement should be signed by the CEO, CFO, direct 
owner, or Chairman of the Board. According to Bureau of Labor 
Statistics wage data, the mean hourly wage for occupation code 11-1011, 
Chief Executives, is $72.77. We estimate the loaded rate to be $145.54. 
Thus, the cost associated with the act of certification is $41.6 
million (571,947 x .5 x $145.54).
    The direct cost of collecting and maintaining certifications made 
by sub-recipients is estimated as the labor cost. We assume that each 
of the 63,741 grant awardees and 4,245 contractors doing business with 
HHS have at least one sub-recipient. We also assume that, on average, 
each grant awardee and contractor will spend one hour collecting and 
maintaining certifications made by sub-recipients. The mean hourly wage 
for office and administrative support occupations, occupation code 43-
0000, is $15.00, or $30 loaded. Thus the cost of collecting and 
maintaining records is estimated to be $2 million (67,986 entities x 1 
hour x $30).
    Comment: One Comment suggested the analysis should consider the 
legal fees likely to flow from litigation over the proposed 
regulations.
    Response: HHS disagrees. In assessing the costs and benefits of 
regulations, the government assumes compliance. Thus, the amount of 
litigation is assumed to be minimal and very difficult to predict.
    The total quantifiable costs of the regulation are estimated to be 
$43.6 million each year.

Congressional Review Act

    The Congressional Review Act defines a ``major rule'' as ``any rule 
that the Administrator of the Office of Information and Regulatory 
Affairs (OIRA) of the Office of Management and Budget finds has 
resulted in or is likely to result in--(A) an annual effect on the 
economy of $100,000,000 or more; (B) a major increase in costs or 
prices for consumers, individual industries, federal, State, or local 
government agencies, or geographic regions; or (C) significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based enterprises to 
compete with foreign-based enterprises in domestic and export 
markets.'' 5 U.S.C. 804(2). Based on OMB's review of the rule under 
Executive Order 12866, the Administrator of OIRA has determined that 
this rule is not a major rule for purposes of the Congressional Review 
Act. This finding of the Administrator is not subject to judicial 
review. 5 U.S.C. 805.

Regulatory Flexibility Act

    HHS has examined the economic implications of this final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would lessen the economic effect of the rule on 
small entities. This will not impose significant costs on small 
entities. Therefore, the Secretary certifies that this rule will not 
result in a significant impact on a substantial number of small 
entities.
    Comment: One Comment suggested HHS should assess the impact on 
small entities who will incur costs to hire new staff and make staffing 
changes to accommodate objections by workforce members.
    Response: HHS acknowledges that there may be indirect costs 
associated with the certification requirement including costs for such 
actions as staffing/scheduling changes and internal reviews to assess 
compliance. As stated in the proposed rule, there continues to be 
insufficient data to estimate the number of funding recipients not 
currently compliant with the Church Amendments, PHS Act Sec.  245, or 
the Weldon Amendment. Because together these three federal statutes 
have been in existence for many years, we expect the incremental and 
indirect costs of certification to be minimal for Department funding 
recipients. HHS received no Comments on this assumption. Therefore, we 
continue to conclude that these indirect costs of certification will be 
minimal.

Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires cost-benefit and other analyses before any rulemaking if 
the rule would include 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 about $115 million. HHS has determined that this 
final rule would not constitute a significant rule under the Unfunded 
Mandates Reform Act.

Federalism

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a final rule that imposes 
substantial direct requirement costs on state and local governments, 
preempts State law, or otherwise has federalism implications.
    All three statutes implemented through this regulation--the Church 
Amendments, PHS Act Sec.  245, and the Weldon Amendment--impose 
restrictions on States, local governments, and public entities 
receiving funds from the Department, including under certain 
Department-implemented statutes. Insofar as these regulations impact 
State and local governments in addition to those impacts caused by the 
statutory provisions, they do so only to the extent that States and 
local governments are required to submit certifications of compliance 
with the statutes and this

[[Page 78096]]

regulation, as applicable. Since we expect the recipients of Department 
funds to comply with existing federal law, we anticipate the impact on 
States and local governments of the certification requirement to be 
negligible.
    The Department received Comments from a number of States, State 
officials, or components of State governments on the proposed rule. The 
Department considered those Comments in finalizing the rule.

Assessment of Federal Regulation and Policies on Families

    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.
    Comment: Several Comments disagreed with the Department's assertion 
in the proposed rule that the regulation will not have an impact on 
family well-being. Another Commenter stated that the Treasury and 
General Government Appropriations Act of 1999 requires the Department 
to determine if the proposed rule would affect family well-being. The 
Commenter stated that if family well-being is affected, the Department 
must provide an impact assessment of these effects. The Commenter also 
stated that the proposed rule does not adequately address the impact on 
family well-being.
    Response: The Department disagrees. This final rule defines certain 
key terms, ensures that recipients of Department funds know about their 
legal obligations under existing federal health care provider 
conscience protection provisions, and requires written certification by 
certain recipients that they will comply with such provisions, as 
applicable. As stated above, the rule does not expand the scope of 
existing federal health care conscience protection laws, nor does it 
create new barriers to health care access that might have an impact on 
family well-being. The Department finds that this rule does not affect 
family well-being within the meaning of meaning of section 654 of the 
Treasury and General Government Appropriations Act, 1999, enacted as 
part of the Omnibus Consolidated and Emergency Supplemental 
Appropriations Act, 1999 (Pub. L. 105-277, 112 Stat. 2681).

V. Paperwork Reduction Act of 1995

    HHS received Comments on the burden associated with the written 
certification requirements contained in sections 88.5(a), (c) and (d) 
of this final rule and are therefore soliciting Comments on the 
information collection requirements associated with this rule, 
consistent with the Paperwork Reduction Act of 1995.
    To obtain or retain federal funding for various activities, the 
Department requires the certification of all recipients and sub-
recipients of Department funding. The certification and associated 
documents are necessary to ensure that recipients and sub-recipients of 
federal funds comply with federal anti-discrimination law.
    Likely respondents to this certification requirement include all 
entities required to certify as estimated in the EO 12866 analysis 
listed above, which provides a high estimate of 571,947 recipients and 
sub-recipients. As outlined above, it will take an estimated 30 minutes 
for each recipient and sub-recipient to review the relevant language 
and provide the relevant certifications as well as, in the case of 
recipients, to collect and maintain certifications by sub-recipients, 
as applicable. The Department therefore estimates the annual aggregate 
burden to collect the information to be as follows:
    The Department is seeking public Comments on the proposed data 
collection associated with this final rule through a 60-day Federal 
Register notice. Interested persons are invited to send Comments 
regarding this burden estimate or any other aspect of this collection 
of information, including any of the following subjects: (1) The 
necessity and utility of the proposed information collection for the 
proper performance of the agency's functions; (2) the accuracy of the 
estimated burden; (3) ways to enhance the quality, utility, and clarity 
of the information to be collected; and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.
    This final rule becomes effective 30 days after publication. 
However, affected parties do not have to comply with the information 
collection requirements in the final rule until the Department of 
Health and Human Services publishes in the Federal Register the control 
numbers assigned by the Office of Management and Budget (OMB). 
Publication of the control numbers notifies the public that OMB has 
approved these information collection requirements under the Paperwork 
Reduction Act of 1995.

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.

0
Therefore, under the Church Amendments, 42 U.S.C. 300a-7, Public Health 
Service Act Sec.  245, 42 U.S.C. 238n, the Weldon Amendment, 
Consolidated Appropriations Act, 2008, Public Law 110-161, Div. G, 
Sec.  508(d), 121 Stat. 1844, 2209, and 5 U.S.C. 301, and for the 
reasons set forth in the preamble, the Department of Health and Human 
Services is amending 45 CFR Subtitle A, Subchapter A by adding Part 88 
to read as follows:

PART 88--ENSURING THAT DEPARTMENT OF HEALTH AND HUMAN SERVICES 
FUNDS DO NOT SUPPORT COERCIVE OR DISCRIMINATORY POLICIES OR 
PRACTICES

Sec.
88.1 Purpose.
88.2 Definitions.
88.3 Applicability.
88.4 Requirements and prohibitions.
88.5 Written certification of compliance.
88.6 Complaint handling and investigating.

    Authority: 42 U.S.C. 300a-7, 42 U.S.C. 238n, Public Law 110-161, 
Div. G, Sec.  508(d), 121 Stat. 1884, 2209, 31, 42 U.S.C. 1395w-
22(j)(3)(B), 42 U.S.C. 1396u-2(b)(3), and 5 U.S.C. 301.


Sec.  88.1  Purpose.

    The purpose of this Part is to provide for the implementation and 
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, 2008, Public Law 110-161, 
Div. G, Sec.  508(d), 121 Stat. 1844, 2209 (collectively referred to as 
the federal healthcare conscience protection statutes). These statutory 
provisions protect the rights of health care entities/entities, both 
individuals and institutions, to refuse to perform health care services 
and research activities to which they may object for religious, moral, 
ethical, or other

[[Page 78097]]

reasons. Consistent with this objective to protect the conscience 
rights of health care entities/entities, the provisions in the Church 
Amendments, section 245 of the Public Health Service Act and the Weldon 
Amendment, and the implementing regulations contained in this Part are 
to be interpreted and implemented broadly to effectuate their 
protective purposes.


Sec.  88.2  Definitions.

    For the purposes of this part:
    Assist in the Performance means to participate in any activity with 
a reasonable connection to a procedure, health service or health 
service program, or research activity, so long as the individual 
involved is a part of the workforce of a Department-funded entity. This 
includes counseling, referral, training, and other arrangements for the 
procedure, health service, or research activity.
    Entity includes an individual physician or other health care 
professional, health care personnel, a participant in a program of 
training in the health professions, an applicant for training or study 
in the health professions, a post graduate physician training program, 
a hospital, a provider-sponsored organization, a health maintenance 
organization, a health insurance plan, laboratory or any other kind of 
health care organization or facility. It may also include components of 
State or local governments.
    Health Care Entity includes an individual physician or other health 
care professional, health care personnel, a participant in a program of 
training in the health professions, an applicant for training or study 
in the health professions, a post graduate physician training program, 
a hospital, a provider-sponsored organization, a health maintenance 
organization, a health insurance plan, laboratory or any other kind of 
health care organization or facility. It may also include components of 
State or local governments.
    Health Service Program includes any plan or program that provides 
health benefits, whether directly, through insurance, or otherwise, 
which is funded, in whole or in part, by the Department. It may also 
include components of State or local governments.
    Individual means a member of the workforce of an entity/health care 
entity.
    Instrument is the means by which federal funds are conveyed to a 
recipient, and includes grants, cooperative agreements, contracts, 
grants under a contract, memoranda of understanding, and any other 
funding or employment instrument or contract.
    Recipient means an organization or individual receiving funds 
directly from the Department or component of the Department to carry 
out a project or program. The term includes State and local 
governments, public and private institutions of higher education, 
public and private hospitals, commercial organizations, and other 
quasi-public and private nonprofit organizations such as, but not 
limited to, community action agencies, research institutes, educational 
associations, and health centers. The term may include foreign or 
international organizations (such as agencies of the United Nations) 
which are recipients, sub-recipients, or contractors or subcontractors 
of recipients or sub-recipients at the discretion of the Department 
awarding agency.
    Sub-recipient means an organization or individual receiving funds 
indirectly from the Department or component of the Department through a 
recipient or another sub-recipient to carry out a project or program. 
The term includes State and local governments, public and private 
institutions of higher education, public and private hospitals, 
commercial organizations, and other quasi-public and private nonprofit 
organizations such as, but not limited to, community action agencies, 
research institutes, educational associations, and health centers. The 
term may include foreign or international organizations (such as 
agencies of the United Nations) which are recipients, sub-recipients, 
or contractors or subcontractors of recipients or sub-recipients at the 
discretion of the Department awarding agency.
    Workforce means employees, volunteers, trainees, contractors, and 
other persons whose conduct, in the performance of work for a 
Department-funded entity, is under the control or authority of such 
entity, whether or not they are paid by the Department-funded entity, 
or health care providers holding privileges with the entity.


Sec.  88.3  Applicability.

    (a) The Department of Health and Human Services is required to 
comply with sections Sec. Sec.  88.4(a), (b)(1), and (d)(1) of this 
part.
    (b) Any State or local government that receives federal funds 
appropriated through the appropriations act for the Department of 
Health and Human Services is required to comply with Sec. Sec.  
88.4(b)(1) and 88.5 of this part.
    (c) Any entity that receives federal funds appropriated through the 
appropriations act for the Department of Health and Human Services to 
implement any part of any federal program is required to comply with 
Sec. Sec.  88.4(b)(2) and 88.5 of this part.
    (d) Any State or local government that receives federal financial 
assistance is required to comply with Sec. Sec.  88.4(a) and 88.5 of 
this part.
    (e) Any State or local government, any part of any State or local 
government, or any other public entity must comply with Sec.  88.4(e) 
of this part.
    (f)(1) Any entity, including a State or local government, that 
receives a grant, contract, loan, or loan guarantee under the Public 
Health Service Act, the Community Mental Health Centers Act, or the 
Developmental Disabilities Assistance and Bill of Rights Act of 2000, 
must comply with Sec. Sec.  88.4(c)(1) and 88.5 of this part.
    (2) In addition to complying with the provisions set forth in Sec.  
88.4(c)(1) of this part, any such entity that is an educational 
institution, teaching hospital, or program for the training of health 
care professionals or health care workers shall also comply with Sec.  
88.4(c)(2) of this part.
    (g)(1) Any entity, including a State or local government, that 
carries out any part of any health service program or research activity 
funded in whole or in part under a program administered by the 
Secretary of Health and Human Services must comply with Sec. Sec.  
88.4(d)(1) and 88.5 of this part.
    (2) In addition to complying with the provisions set forth in 
(g)(1) of this section, any such entity that receives grants or 
contracts for biomedical or behavioral research under any program 
administered by the Secretary of Health and Human Services shall also 
comply with Sec. Sec.  88.4(d)(2) of this part.


Sec.  88.4  Requirements and prohibitions.

    (a) Entities to whom this paragraph (a) applies shall not:
    (1) Subject any institutional or individual health care entity to 
discrimination for refusing:
    (i) To undergo training in the performance of abortions, or to 
require, provide, refer for, or make arrangements for training in the 
performance of abortions;
    (ii) To perform, refer for, or make other arrangements for, 
abortions; or
    (iii) To refer for abortions;
    (2) Subject any institutional or individual health care entity to 
discrimination for attending or having attended a post-graduate 
physician training program, or any other program of training in the 
health professions, that does not or did not require attendees to 
perform induced abortions or require, provide, or refer for training

[[Page 78098]]

in the performance of induced abortions, or make arrangements for the 
provision of such training;
    (3) For the purposes of granting a legal status to a health care 
entity (including a license or certificate), or providing such entity 
with financial assistance, services or benefits, fail to deem 
accredited any postgraduate physician training program that would be 
accredited but for the accrediting agency's reliance upon an 
accreditation standard or standards that require an entity to perform 
an induced abortion or require, provide, or refer for training in the 
performance of induced abortions, or make arrangements for such 
training, regardless of whether such standard provides exceptions or 
exemptions;
    (b)(1) Any entity to whom this paragraph (b)(1) applies shall not 
subject 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, abortion.
    (2) Entities to whom this paragraph (b)(2) applies shall not 
subject 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 abortion, as part 
of the federal program for which it receives funding.
    (c) Entities to whom this paragraph (c) applies shall not:
    (1) Discriminate against any physician or other health care 
professional in the employment, promotion, termination, or extension of 
staff or other privileges because he performed or assisted in the 
performance, or refused to perform or assist in the performance of a 
lawful sterilization procedure or abortion on the grounds that doing so 
would be contrary to his religious beliefs or moral convictions, or 
because of his religious beliefs or moral convictions concerning 
abortions or sterilization procedures themselves;
    (2) Discriminate against or deny admission to any applicant for 
training or study because of reluctance or willingness to counsel, 
suggest, recommend, assist, or in any way participate in the 
performance of abortions or sterilizations contrary to or consistent 
with the applicant's religious beliefs or moral convictions.
    (d) Entities to whom this paragraph (d) applies shall not:
    (1) Require any individual to perform or assist in the performance 
of any part of a health service program or research activity funded by 
the Department if such service or activity would be contrary to his 
religious beliefs or moral convictions.
    (2) Discriminate in the employment, promotion, termination, or the 
extension of staff or other privileges to any physician or other health 
care personnel because he performed, assisted in the performance, 
refused to perform, or refused to assist in the performance of any 
lawful health service or research activity on the grounds that his 
performance or assistance in performance of such service or activity 
would be contrary to his religious beliefs or moral convictions, or 
because of the religious beliefs or moral convictions concerning such 
activity themselves.
    (e) Entities to whom this paragraph (e) applies shall not, on the 
basis that the individual or entity has received a grant, contract, 
loan, or loan guarantee under the Public Health Service Act, the 
Community Mental Health Centers Act, or the Developmental Disabilities 
Assistance and Bill of Rights Act of 2000, require:
    (1) Such individual to perform or assist in the performance of any 
sterilization procedure or abortion if his performance or assistance in 
the performance of such procedure or abortion would be contrary to his 
religious beliefs or moral convictions, or
    (2) Such entity to:
    (i) Make its facilities available for the performance of any 
sterilization procedure or abortion if the performance of such 
procedure or abortion in such facilities is prohibited by the entity on 
the basis of religious beliefs or moral convictions, or
    (ii) provide any personnel for the performance or assistance in the 
performance of any sterilization procedure or abortion if the 
performance or assistance in the performance of such procedure or 
abortion by such personnel would be contrary to the religious beliefs 
or moral convictions of such personnel.


Sec.  88.5  Written certification of compliance.

    (a) Certification Requirement. Except as provided in paragraph (e) 
of this section, recipients shall include the written certifications as 
set forth in paragraph (c)(4) of this section in the application for 
the grant, cooperative agreement, contract, grant under a contract, 
memorandum of understanding or other funding or employment instrument 
or contract, as applicable. Except as provided in paragraph (e) of this 
section, sub-recipients must provide the Certification of Compliance as 
set out in paragraph (d)(3) of this section, submitted as part of the 
sub-recipient's original agreement with the recipient in the execution 
of its grant, cooperative agreement, contract, grant under a contract, 
memorandum of understanding or other funding instrument or contract, or 
in a separate writing, signed by the sub-recipient's officer or other 
person authorized to bind the sub-recipient. All certifications shall 
be addressed directly to the Department; recipients are required to 
submit their certifications directly to the Department. Recipients and 
sub-recipients shall be required to be in full compliance with all 
applicable certification requirements by no later than the beginning of 
the federal fiscal year following the effective date of this 
regulation.
    (b) Notification of Certification Requirement. The Department shall 
notify recipients of funding of the certification requirement at the 
time of award through the Request for Proposal, Request for Agreement, 
Provider Agreement, contract, guidance, or other public announcement of 
the availability of funding. Recipients shall not construe anything in 
this paragraph to mean that an entity or organization is in any way 
exempt from providing the certification in the event the Department 
should fail to provide notification.
    (c) Certification by recipients. (1) Except as provided in 
paragraph (e) of this section, all recipients through any instrument 
must provide the Certification of Compliance as set out in paragraph 
(c)(4) of this section, submitted as part of the recipient's 
application for the grant, cooperative agreement, contract, grant under 
a contract, memorandum of understanding or other funding instrument or 
contract or in a separate writing signed by the recipients' officer or 
other person authorized to bind the recipient.
    (2) Recipients must file with the Department a renewed 
certification upon any renewal, extension, amendment, or modification 
of the grant, cooperative agreement, contract, grant under a contract, 
memorandum of understanding or other funding or employment instrument 
or contract that extends the term of such instrument or adds additional 
funds to it. Recipients that are already recipients as of the effective 
date of this regulation must file a certification upon any extension, 
amendment, or modification of the grant, cooperative agreement, 
contract, grant under a contract, memorandum of understanding or other 
funding instrument or contract that extends the term of such instrument 
or adds additional funds to it.
    (3) Recipients shall require certifications and re-certifications 
by all sub-recipients that receive funding through their association 
with the

[[Page 78099]]

recipient. Recipients shall require these certifications and re-
certifications as often as recipients are required to sign or amend the 
instrument, for as long as the relationship between the recipient and 
the sub-recipient lasts. Recipients shall collect and maintain sub-
recipient certifications for as long as the relationship between the 
recipient and the sub-recipient lasts, and for a reasonable time after 
the relationship ends, for the purpose of investigations, litigation, 
or other purposes.
    (4) Except as provided in paragraph (e) of this section, all 
recipients shall provide the following certification:
    ``As the duly authorized representative of the recipient I certify 
that the recipient of funds made available through this [instrument] 
will not [check all that are appropriate]:

--[if recipient is a state or local government receiving federal 
funds appropriated through the appropriations act for the U.S. 
Department of Health and Human Services] subject 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, abortion.
--[if recipient is an entity receiving federal funds appropriated 
through the appropriations act for the U.S. Department of Health and 
Human Services to implement any part of any federal program] subject 
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 abortion as part of the federal 
program for which it receives funding.
--[if recipient is a State or local government that receives federal 
financial assistance]

    (1) Subject any institutional or individual health care entity to 
discrimination for refusing: (a) To undergo training in the performance 
of abortions, or to require, provide, refer for, or make arrangements 
for training in the performance of abortions; (b) to perform, refer 
for, or make other arrangements for, abortions; or (c) to refer for 
abortions.
    (2) subject any institutional or individual health care entity to 
discrimination for attending or having attended a post-graduate 
physician training program, or any other program of training in the 
health professions, that does not or did not require attendees to 
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.
    (3) for the purposes of granting a legal status to a health care 
entity (including a license or certificate), or providing such entity 
with financial assistance, services or benefits, fail to deem 
accredited any postgraduate physician training program that would be 
accredited but for the accrediting agency's reliance upon an 
accreditation standard or standards that require an entity to perform 
an induced abortion or require, provide, or refer for training in the 
performance of induced abortions, or make arrangements for such 
training, regardless of whether such standard provides exceptions or 
exemptions.

--[if recipient is a State or local government, any part of any 
State or local government, or any other public entity] on the basis 
that the individual or entity has received a grant, contract, loan, 
or loan guarantee under the Public Health Service Act, the Community 
Mental Health Centers Act, or the Developmental Disabilities 
Assistance and Bill of Rights Act of 2000, require such individual 
to perform or assist in the performance of any sterilization 
procedure or abortion if his performance or assistance in the 
performance of such procedure or abortion would be contrary to his 
religious beliefs or moral convictions, or such entity to make its 
facilities available for the performance of any sterilization 
procedure or abortion if the performance of such procedure or 
abortion in such facilities is prohibited by the entity on the basis 
of religious beliefs or moral convictions, or provide any personnel 
for the performance or assistance in the performance of any 
sterilization procedure or abortion if the performance or assistance 
in the performance of such procedure or abortion by such personnel 
would be contrary to the religious beliefs or moral convictions of 
such personnel.
--[if recipient is any entity (including a state or local 
government) that receives a grant, contract, loan, or loan guarantee 
under the Public Health Service Act, the Community Mental Health 
Centers Act, or the Developmental Disabilities Assistance and Bill 
of Rights Act of 2000] discriminate against any physician or other 
health care professional in the employment, promotion, termination, 
or extension of staff or other privileges because he performed or 
assisted in the performance, or refused to perform or assist in the 
performance of a lawful sterilization procedure or abortion on the 
grounds that doing so would be contrary to his religious beliefs or 
moral convictions, or because of his religious beliefs or moral 
convictions concerning abortions or sterilization procedures 
themselves.
--[if recipient is any entity (including a state or local 
government) that receives a grant, contract, loan, or loan guarantee 
under the Public Health Service Act, the Community Mental Health 
Centers Act, or the Developmental Disabilities Assistance and Bill 
of Rights Act of 2000 that is an educational institution, teaching 
hospital, or program for the training of health care professionals 
or health care workers] discriminate against or deny admission to 
any applicant for training or study because of reluctance or 
willingness to counsel, suggest, recommend, assist, or in any way 
participate in the performance of abortions or sterilizations 
contrary to or consistent with the applicant's religious beliefs or 
moral convictions.
--[if recipient is an entity, including a State or local government, 
that carries out any part of any health service program or research 
activity funded in whole or in part under a program administered by 
the U.S. Secretary of Health and Human Services] require any 
individual to perform or assist in the performance of any part of a 
health service program or research activity funded by the U.S. 
Department of Health and Human Services if such service or activity 
would be contrary to his religious beliefs or moral convictions.
--[if recipient is an entity that receives grants or contracts for 
biomedical or behavioral research under any program administered by 
the U.S. Secretary of Health and Human Services] discriminate in the 
employment, promotion, termination, or the extension of staff or 
other privileges to any physician or other health care personnel 
because he performed, assisted in the performance, refused to 
perform, or refused to assist in the performance of any lawful 
health service or research activity on the grounds that his 
performance or assistance in performance of such service or activity 
would be contrary to his religious beliefs or moral convictions, or 
because of the religious beliefs or moral convictions concerning 
such activity themselves.''
--[All recipients] I further certify that the recipient acknowledges 
that any violation of these certifications may result in termination 
by the Department of any grant, cooperative agreement, contract, 
grant under a contract, memorandum of understanding or other funding 
or employment instrument or contract prior to the end of its term 
and recovery of appropriated funds expended prior to termination, 
and may be used as such at the Department's discretion. I further 
certify that, except as provided in 45 CFR 88.5(e), the recipient 
will include this certification requirement in any [instrument] to a 
sub-recipient of funds made available under this instrument, and 
will require, except as provided in 45 CFR 88.5(e), such sub-
recipient to provide the same certification that the recipient 
organization or entity provided. I further certify the recipient 
organization will collect and maintain sub-recipient certifications 
for as long as the relationship between the recipient and the sub-
recipient lasts, and for a reasonable time after the relationship 
ends, for the purpose of investigations, litigation, or other 
purposes.''

    (d) Certification by Sub-recipients. (1) Except as provided in 
paragraph (e) of this section, organizations or entities that are sub-
recipients of the organization or entity providing the initial 
Certification of Compliance must submit to the recipient for 
maintenance by the recipient through which the sub-recipient receives 
Department funds Certification of Compliance as set out in paragraph 
(d)(3) of this section, as part of the grant, cooperative agreement,

[[Page 78100]]

contract, grant under a contract, memorandum of understanding or other 
funding instrument or contract between the recipient and the sub-
recipient or in a separate writing signed by the sub-recipients' 
officer or other person authorized to bind the sub-recipient.
    (2) Except as provided in paragraph (e) of this section, sub-
recipients of funds shall renew certification to the recipient through 
which it receives Department funds upon any renewal, extension, 
amendment, or modification of the grant, cooperative agreement, 
contract, grant under a contract, memorandum of understanding or other 
funding or employment instrument or contract that extends the term of 
such instrument or adds additional funds to it. Sub-recipients shall 
submit such renewals to the recipient entities through which they 
receive Department funding. Entities that are already sub-recipients as 
of the effective date of this regulation must certify upon any 
extension, amendment, or modification of the grant, cooperative 
agreement, contract, grant under a contract, memorandum of 
understanding or other funding instrument or contract that extends the 
term of such instrument or adds additional funds to it, and shall 
submit such certifications to the recipient entity through which they 
receive Department funding.
    (3) Except as provided in paragraph (e) of this section, all sub-
recipients of Department funds shall provide the following 
certification:
    ``As the duly authorized representative of the sub-recipient I 
certify that the sub-recipient of funds made available through this 
[instrument] will not [check all that are appropriate]:
--[if sub-recipient is a State or local government receiving federal 
funds appropriated through the appropriations act for the U.S. 
Department of Health and Human Services] subject 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, abortion.
--[if sub-recipient is an entity receiving federal funds 
appropriated through the appropriations act for the U.S. Department 
of Health and Human Services to implement any part of any federal 
program] subject 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 abortion as part 
of the federal program for which it receives funding.
--[if sub-recipient is a State or local government that receives 
federal financial assistance]

    (1) Subject any institutional or individual health care entity to 
discrimination for refusing: (a) To undergo training in the performance 
of abortions, or to require, provide, refer for, or make arrangements 
for training in the performance of abortions; (b) to perform, refer 
for, or make other arrangements for, abortions; or (c) to refer for 
abortions.
    (2) subject any institutional or individual health care entity to 
discrimination for attending or having attended a post-graduate 
physician training program, or any other program of training in the 
health professions, that does not or did not require attendees to 
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.
    (3) for the purposes of granting a legal status to a health care 
entity (including a license or certificate), or providing such entity 
with financial assistance, services or benefits, the recipient will not 
fail to deem accredited any postgraduate physician training program 
that would be accredited but for the accrediting agency's reliance upon 
an accreditation standard or standards that require an entity to 
perform an induced abortion or require, provide, or refer for training 
in the performance of induced abortions, or make arrangements for such 
training, regardless of whether such standard provides exceptions or 
exemptions.
--[if sub-recipient is a State or local government, any part of any 
State or local government, or any other public entity] on the basis 
that the individual or entity has received a grant, contract, loan, 
or loan guarantee under the Public Health Service Act, the Community 
Mental Health Centers Act, or the Developmental Disabilities 
Assistance and Bill of Rights Act of 2000, require such individual 
to perform or assist in the performance of any sterilization 
procedure or abortion if his performance or assistance in the 
performance of such procedure or abortion would be contrary to his 
religious beliefs or moral convictions, or such entity to make its 
facilities available for the performance of any sterilization 
procedure or abortion if the performance of such procedure or 
abortion in such facilities is prohibited by the entity on the basis 
of religious beliefs or moral convictions, or provide any personnel 
for the performance or assistance in the performance of any 
sterilization procedure or abortion if the performance or assistance 
in the performance of such procedure or abortion by such personnel 
would be contrary to the religious beliefs or moral convictions of 
such personnel.
--[if sub-recipient is any entity (including a state or local 
government) that receives these funds through a recipient which 
received them through a grant, contract, loan, or loan guarantee 
under the Public Health Service Act, the Community Mental Health 
Centers Act, or the Developmental Disabilities Assistance and Bill 
of Rights Act of 2000] discriminate against any physician or other 
health care professional in the employment, promotion, termination, 
or extension of staff or other privileges because he performed or 
assisted in the performance, or refused to perform or assist in the 
performance of a lawful sterilization procedure or abortion on the 
grounds that doing so would be contrary to his religious beliefs or 
moral convictions, or because of his religious beliefs or moral 
convictions concerning abortions or sterilization procedures 
themselves.
--[if sub-recipient is any entity (including a State or local 
government) that receives these funds through a recipient which 
received them through a grant, contract, loan, or loan guarantee 
under the Public Health Service Act, the Community Mental Health 
Centers Act, or the Developmental Disabilities Assistance and Bill 
of Rights Act of 2000 that is an educational institution, teaching 
hospital, or program for the training of health care professionals 
or health care workers] discriminate against or deny admission to 
any applicant for training or study because of reluctance or 
willingness to counsel, suggest, recommend, assist, or in any way 
participate in the performance of abortions or sterilizations 
contrary to or consistent with the applicant's religious beliefs or 
moral convictions.
--[if sub-recipient is an entity (including a State or local 
government) that carries out any part of any health service program 
or research activity funded in whole or in part under a program 
administered by the U.S. Secretary of Health and Human Services] 
require any individual to perform or assist in the performance of 
any part of a health service program or research activity funded by 
the U.S. Department of Health & Human Services if such service or 
activity would be contrary to his religious beliefs or moral 
convictions.
--[if sub-recipient is an entity that these funds through a 
recipient which received them through receives grants or contracts 
for biomedical or behavioral research under any program administered 
by the U.S. Secretary of Health and Human Services] discriminate in 
the employment, promotion, termination, or the extension of staff or 
other privileges to any physician or other health care personnel 
because he performed, assisted in the performance, refused to 
perform, or refused to assist in the performance of any lawful 
health service or research activity on the grounds that his 
performance or assistance in performance of such service or activity 
would be contrary to his religious beliefs or moral convictions, or 
because of the religious beliefs or moral convictions concerning 
such activity themselves.''
--[All sub-recipients] I further certify that the sub-recipient 
acknowledges that these certifications by the sub-recipient of funds 
are certifications made directly to the Department and that any 
violation of these certifications may result in termination by the 
Department of the recipient's grant, cooperative agreement, 
contract, grant

[[Page 78101]]

under a contract, memorandum of understanding or other funding or 
employment instrument or contract prior to the end of its term and 
recovery of appropriated funds expended prior to termination, and 
may be used as such at the Department's discretion. I further 
certify that the sub-recipient will submit all certifications to the 
recipient entity through which it received Department funds.''

    (e) Exceptions. Provided that such individuals or organizations are 
not recipients or sub-recipients of Department funds through another 
instrument, program, or mechanism, other than those set forth in 
paragraph (e)(1) through (e)(6) of this section, the following 
individuals or organizations shall not be required to comply with the 
written certification requirements set forth in this section:
    (1) A physician, as defined in 42 U.S.C. 1395(r), physician office, 
or other health care practitioner participating in Part B of the 
Medicare program;
    (2) A physician, as defined in 42 U.S.C. 1395(r), physician office, 
or other health care practitioner which participates in Part C of the 
Medicare program, when such individuals or organizations are sub-
recipients of Department funds through a Medicare Advantage plan;
    (3) A sub-recipient of Department funds through a State Medicaid 
program;
    (4) A recipient or sub-recipient of Department funds awarded under 
certain grant programs currently administered by the Administration for 
Children and Families, whose purpose is either solely financial 
assistance unrelated to health care or which is otherwise unrelated to 
health care provision, and which, in addition, does not involve--
    (i) Medical or behavioral research;
    (ii) The involvement of health care providers;
    (iii) Any significant likelihood of referral for the provision of 
health care;
    (5) A recipient or sub-recipient of Department funds awarded under 
certain grant programs currently administered by the Administration on 
Aging, whose purpose is either solely financial assistance unrelated to 
health care or which is otherwise unrelated to health care provision, 
and which, in addition, does not involve--
    (i) Medical or behavioral research;
    (ii) The involvement of health care providers;
    (iii) Any significant likelihood of referral for the provision of 
health care; and
    (6) Indian Tribes and Tribal Organizations when contracting with 
the Indian Health Service under the Indian Self-Determination and 
Education Assistance Act.


Sec.  88.6  Complaint handling and investigating.

    The Office for Civil Rights (OCR) of the Department of Health and 
Human Services has been designated to receive complaints of 
discrimination and coercion based on the health care conscience 
protection statutes and this regulation. OCR will coordinate handling 
of complaints with the staff of the Departmental programs from which 
the entity, with respect to which a complaint has been filed, receives 
funding (i.e., Department funding component).

    Dated: December 3, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8-30134 Filed 12-18-08; 8:45 am]
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