Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law, 78072-78101 [E8-30134]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Rules and Regulations]
[Pages 78072-78101]
From the Federal Register Online via the Government Printing 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

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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.
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    \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 prote