[Federal Register: August 26, 2008 (Volume 73, Number 166)]
[
Proposed Rules]
[Page 50274-50285]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au08-26]
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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: Proposed rule.
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SUMMARY: The Department of Health and Human Services proposes to
promulgate regulations 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, Pub. L. 110-
161, Sec. 508(d), 121 Stat. 1844, 2209). This notice of proposed
rulemaking proposes to define certain key terms. Furthermore, in order
to ensure that recipients of Department funds know about their legal
obligations under these nondiscrimination provisions, the Department
proposes to require written certification by certain recipients that
they will comply with all three statutes, as applicable.
DATES: Submit written or electronic comment on the regulations proposed
by this document by September 25, 2008.
ADDRESSES: In commenting, please refer to ``Provider Conscience
Regulation''. Because of staff and resource limitations, we cannot
accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on this
regulation to http://www.Regulations.gov or via e-mail to
consciencecomment@hhs.gov. To submit electronic comments to http://
www.Regulations.gov, go to the Web site and click on the link ``Comment
or Submission'' and enter the keywords ``provider conscience''.
(Attachments should be in Microsoft Word, WordPerfect, or Excel;
however, we prefer Microsoft Word.)
2. By regular mail. You may mail written comments (one original and
two copies) to the following address only: Office of Public Health and
Science, Department of Health and Human Services, Attention: Brenda
Destro, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Room
728E, Washington, DC 20201.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address only: Office of
Public Health and Science, Department of Health and Human Services,
Attention: Brenda Destro, Hubert H. Humphrey Building, 200 Independence
Avenue, SW., Room 728E, Washington, DC 20201.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to the following address: Room 728E, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201. (Because access to the interior of the Hubert H. Humphrey
Building is not readily available to persons without Federal Government
Identification, commenters are encouraged to leave their comments in
the mail drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain proof of filing by
stamping in and retaining and extra copy of the documents being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submitting Comments: We welcome comments from the public on all
issues set forth in this proposed rule to assist us in fully
considering issues and developing policies. For all comments submitted,
you should specify the subject as ``Provider Conscience Regulation''.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://
www.Regulations.gov. Click on the link ``Comment or Submission'' on
that Web site to view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of
[[Page 50275]]
the Department of Health and Human Services, Hubert H. Humphrey
Building, 200 Independence Avenue, SW., Washington, DC 20201, Monday
through Friday of each week from 8:30 a.m. to 4 p.m.
Electronic Access
This Federal Register document is also available from the Federal
Register online database through GPO Access, a service of the U.S.
Government Printing Office. Free public access is available on a Wide
Area Information Server (WAIS) through the Internet and via
asynchronous dial-in. Internet users can access the database by using
the World Wide Web (the Superintendent of Documents' home page address
is http://www.gpoaccess.gov/), by using local WAIS client software, or
by telnet to swais.access.gpo.gov, then login as guest (no password
required). Dial-in users should used communications software and modem
to call (202) 512-1661; type swais, then login as guest (no password
required).
FOR FURTHER INFORMATION 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.
SUPPLEMENTARY INFORMATION:
I. Background
Religious liberty and freedom of conscience have long been
protected in the Constitution and laws of the United States. Workers in
all sectors of the economy enjoy legal protection of their consciences
and religious liberties. In federal law, there are several provisions
that 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 provision that prohibits the federal governments 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 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.
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
provide 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.''
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
[[Page 50276]]
arrangements for the provision of such training. 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 otherwise would be accredited but for the
reliance on an accrediting standard that 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 No.
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 No. 110-161,
Div. G, Sec. 508(d), 121 Stat. 1844, 2209. 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 Laws in the Courts
The federal courts have recognized the breadth and importance of
statutory and other conscience protections for health care
professionals and workers. Shortly after its passage, a federal
appellate court decision characterized the importance of conscience
protections contained in the Church Amendments. Faced with the question
of a denominational hospital's right to refuse to perform sterilization
procedures, the Ninth Circuit affirmed a lower court decision
protecting the hospital's right to refuse to perform sterilizations and
abortions on religious or moral grounds: ``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).
The Problem
There appears to be an attitude toward the health care professions
that health care professionals and institutions should be required to
provide or assist in the provision of medicine or procedures to which
they object, or else risk being subjected to discrimination. Reflecting
this attitude, in some instances the standards of professional
organizations have been used to define the exercise of conscience to be
unprofessional, forcing health care professionals to choose between
their capacity to practice in good standing and their right of
conscience.\1\
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\1\ ``HHS Secretary Calls on Certification Group to Protect
Conscience Rights,'' March 14, 2008. Available at http://
www.hhs.gov/news/press/2008pres/03/20080314a.html.
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Despite the fact that several conscience statutes protecting health
care entities from discrimination have been in existence for decades,
the Department is concerned that the public and many health care
providers are largely uninformed of the protections afforded to
individuals and institutions under these provisions. This lack of
knowledge within the health professions can be detrimental to
conscience and other rights, particularly for individuals and entities
with moral objections to abortion and other medical procedures.
The Department's Response
In general, the Department is concerned that the development of an
environment in the health care field that is intolerant of individual
conscience, certain religious beliefs, ethnic and cultural traditions,
and moral convictions may discourage individuals from diverse
backgrounds from entering health care professions. Such developments
also promote the mistaken beliefs 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. 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 facing the country.
The Department also notes that, while many recipients of Department
funds currently must certify compliance with federal nondiscrimination
laws, federal conscience protections are not mentioned in existing
forms. For example, Form PHS-5161-1, required as part of Public Health
Service grant applications, requires applicants to certify compliance
with all federal nondiscrimination laws, including laws prohibiting
discrimination on the basis of race, color, national origin, religion,
sex, handicap, age, drug abuse, and alcohol abuse or alcoholism. The
Department seeks to raise awareness of federal conscience 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.
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 nondiscrimination laws
through the various Department mechanisms, 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 healthcare industry,
and between providers and patients, fostering a more
[[Page 50277]]
inclusive, tolerant environment in the health care industry than may
currently exist.
This regulation does not limit patient access to health care, but
rather protects any individual health care provider or institution from
being compelled to participate in, or from being punished for refusal
to participate in, a service that, for example, violates their
conscience.
These proposed actions are consistent with the Administration's
current efforts to ensure that community and faith-based organizations
are able to participate in federal programs on a level playing field
with other organizations.
II. Summary of the Proposed Rule
This proposed rule sets out, and provides further definition of,
the rights and responsibilities created by the federal
nondiscrimination provisions. It clarifies the scope of
nondiscrimination protections to applicable members of the Department's
workforce, as well as and health care entities and members of the
workforces of entities receiving Department funds. This proposed rule
would also require certain recipients of Department funds to certify
compliance with these requirements. In order to ensure proper
enforcement, this proposed rule would define certain terms for the
purposes of this proposed regulation.
The Office for Civil Rights of the Department of Health and Human
Services has been designated to receive complaints of discrimination
based on the nondiscrimination statutes and this proposed regulation.
It 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. Enforcement of the
requirements set forth in this proposed regulation will be conducted
through the usual and ordinary program mechanisms. Compliance with the
requirements proposed herein would 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 be in violation of the requirements or prohibitions proposed
herein, the Department would work with such government or entity to
assist such government or entity to 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 nondiscrimination provisions under 45 CFR 74, and other
measures.
III. Statutory Authority
On the basis of the above-mentioned statutory authority, the
Secretary proposes to promulgate these regulations, requiring
certification of compliance with the anti-discrimination statutes.
The statutory provisions discussed above require that the
Department and recipients of Department funds (including State and
local governments) refrain from discriminating against institutional
and individual health care entities for their participation or refusal
to participate in certain medical procedures or services, including
certain health services, or research activities funded in whole or in
part 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. In addition, 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.''
IV. Provisions of the Proposed Rule
Section 88.1 Purpose
The ``Purpose'' section of the regulation sets forth the objective
that the proposed regulation would, when finalized, provide 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.
Section 88.2 Definitions
Assist in the Performance: The Department, in considering how to
interpret the term ``assist in the performance,'' seeks to provide
broad protection for individuals' consciences. The Department seeks to
avoid judging whether a particular action is genuinely offensive to an
individual. At the same time, the Department wishes to guard against
potential abuses of these protections by limiting the definition of
``assist in performance'' only to those actors who have a reasonable
connection to the procedure, health service or health service program,
or research activity to which they object.
Therefore, the Department proposes 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 proposes to include participation in
any activity with a reasonable connection to the objectionable
procedure, including referrals, training, and other arrangements for
offending procedures. For example, an operating room nurse would assist
in the performance of surgical procedures, and an employee whose task
it is to clean the instruments used in a particular procedure would be
considered to assist in the performance of the particular procedure.
Health Care Entity/Entity: 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 the Department has
previously indicated, the definition of ``health care entity'' in PHS
Act Sec. 245 also encompasses institutional entities, such as
hospitals and other entities.\2\ 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.''
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\2\ See Letter from Secretary Tommy G. Thompson to Hon. W.F.
Tauzin, September 24, 2002.
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In keeping with the definitions in PHS Act Sec. 245 and the Weldon
Amendment, the Department proposes to define ``health care entity'' to
include the specifically mentioned organizations from the two statutes,
as well as other types of entities referenced in the Church Amendments.
It is important to note that the Department does not intend for this to
be a comprehensive list of relevant organizations for
[[Page 50278]]
purposes of the regulation, but merely a list of examples.
Health Service/Health Service Program: One of the provisions in the
Church Amendments uses the term ``health service,'' another uses the
term, ``health service program.'' Neither define the terms, nor does
the PHS Act define ``health service program.'' In developing an
appropriate definition for ``health service program,'' we have 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, we propose 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 insurance programs where federal
funds are used to provide access to health coverage (e.g., SCHIP,
Medicaid, and Medicare Advantage). Similarly, we propose that the term
``health service'' means any service so provided.
Individual: For the purposes of this part, the Department proposes
to define ``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).''
Instrument: We propose to use ``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 definition
of ``instrument'' is intended to include all means by which the
Department conveys funding and resources.
Recipient: This term is used to encompass any entity that receives
Department funds directly.
Sub-recipient: This term is used to encompass any entity that
receives Department funds indirectly through a recipient or sub-
recipient.
Workforce: We propose to define ``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 is drawn from the
``Administrative Data Standards and Related Requirements'' rules
implementing 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.
In defining both ``individual'' and ``workforce,'' the Department
proposes 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 propose to 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.
Section 88.3 Applicability
The proposed ``Applicability'' section of the regulation outlines
the certifications various entities must provide in order to receive
Department funds. This section would direct entities to the appropriate
sections that contain the relevant requirements from the three statutes
that form the basis of this regulation.
Section 88.4 Requirements and Prohibitions
The ``Requirements and Prohibitions'' section explains the
obligations that the Church Amendments, PHS Act Sec. 245, and the
Weldon Amendment impose on entities which receive funding from the
Department. These provisions are taken from the relevant statutory
language and make up the elements of the certification provided by the
entities. We intend for the proposed requirements and prohibitions to
be interpreted using the definitions proposed in section 88.2.
Section 88.5 Written Certification of Compliance
In the ``Written Certification of Compliance'' section of the
regulation, the Department seeks 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 non-
discrimination provisions. Under this 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 requires 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)--are required to provide
certification as set out in the ``Sub-recipient'' subsection of the
``Certification of Compliance'' section, and submit them to the
recipients
[[Page 50279]]
through which they receive Department funds for maintenance.
Although it is collected and maintained by the recipient, this
certification by sub-recipients is a certification addressed to the
Department, not to the recipients collecting the certification.
Recipients are 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) contains three
important exceptions from the requirement to provide the written
certification: (1) Physicians, physician offices, and other health care
practitioners participating in Part B of the Medicare program; (2)
physicians, physician offices, or other health care practitioners which
participates in Part B 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 these three categories poses significant
implementation hurdles for Departmental components and programs.
Furthermore, the Department believes that, due primarily to their
generally smaller size, the excepted categories of recipients and sub-
recipients of Department funds are less likely to encounter the types
of issues sought to be addressed in this regulation. However, excepted
providers may become subject to the written certification requirement
by nature of their receiving Department funds under a separate agency
or program. For example, a physician office participating in Medicare
Part B may become subject to the written certification requirement by
receiving Department funds to conduct clinical research. We note,
however, that the State Medicaid programs are responsible for ensuring
the compliance of their sub-recipients as part of ensuring that the
State Medicaid program is operated consistently with applicable
nondiscrimination provisions. The Department is considering whether
other recipients of Department funds from programs that do not involve
the provision of health care should also be excepted from the
certification requirement and we seek comment on this issue.
When finalized, individual Department components will be 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 will be 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.
V. Request for Comment
The Department, in order to craft its final rule to best reflect
the environment within the health care field, seeks comment on this
Proposed Rule. In particular, the Department seeks the following:
Comment on all issues raised by the proposed regulation.
Information with regard to general knowledge or lack
thereof of the protections established by these nondiscrimination
provisions, including any facts, surveys, audits, reports, or any other
evidence of knowledge or lack of knowledge on these matters in the
general public, as well as within the healthcare industry and
educational institutions.
In the past, there has been some confusion about whether
the receipt of federal funds permitted public officials to require
entities to provide abortions or perform sterilizations. The debate was
resolved, and statutory provisions like section (b) of the Church
Amendments [42 U.S.C. 300a-7(b)] were promulgated to protect entities
from public authorities who would claim that the receipt of federal
funds creates a legal obligation for the entity to provide abortions or
sterilization procedures. The Department seeks information, including
any facts, surveys, audits, or reports on whether this remains an
issue, that is, do public authorities continue to claim that the
receipt of federal funds is sufficient basis for entities to be
required to provide abortions or perform sterilizations? If so, how
should the Department address this problem?
Comment 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 also seeks comment on what constitutes the
most effective methods of educating recipients of Department funds,
their employees, and participants of the protections against
discrimination found in the Church Amendments, PHS Act Sec. 245, and
the Weldon Amendment. What is the best method for communicating to the
public the protections afforded by these statutes, and any regulation
implementing them?
[cir] One option is to require the physical posting of notices of
nondiscrimination protections in conspicuous places within the
buildings of recipients of funds, and on applications to educational
programs that are recipients of funds. Have notices been effective
educational tools with respect to individuals' rights under federal
law?
[cir] Another option is to require inclusion of nondiscrimination
protections in notice of applications for training, residency, and
educational programs.
[cir] Another option is requiring notice of nondiscrimination
protections on websites and in employee/volunteer handbooks of
recipients.
The Department seeks further comment on this matter--both on the
merit of the options mentioned, and on any other means of educating the
public with respect to the nondiscrimination protections under federal
law.
Comment on whether there are recipients of Department
funds that should be excepted from the proposed certification
requirement, for example because the program under which such
recipients receive Department funds is unrelated to the provision of
health care or medical research.
VI. Impact Analysis
Executive Order 12866--Regulatory Planning and Review
HHS has examined the economic implications of this proposed rule as
required by Executive Order 12866. Executive Order 12866 directs
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). Executive Order 12866 classifies a
rule as significant if it meets any one of a number of specified
conditions, including: having an annual effect on the economy of $100
million, adversely affecting a 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
[[Page 50280]]
determined that this proposed rule is a significant regulatory action
as defined by Executive Order 12866.
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 and organizations from many different faiths, cultures, 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 believes the future benefits will exceed
the costs of complying with the regulation.
The statutes mandating the requirements for protecting health care
entities and individuals in the health care industry as discussed in
this rule have been in effect for a number of years and the proposed
regulations are consistent with prior Departmental interpretations of
these nondiscrimination statutes; \3\ therefore, the regulatory burden
associated with this rule, if finalized, is largely associated with the
incremental costs of a recipient certifying compliance 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, at
most, 584,294 (see Table I). We do not distinguish between recipients
and sub-recipients of HHS funding. Each entity could be a recipient, a
sub-recipient, or both. In accordance with subsection 88.5(e) below,
physicians, physician offices, and other health care practitioners
participating in Medicare Part B or who are sub-recipients assisting in
the implementation of a State Medicaid program are not subject to the
written certification requirement; however, a high estimate of the
number of physician offices and offices of other health care
practitioners who may be required to certify as recipients or sub-
recipients of Department funds through other programs, instruments, or
mechanisms is included.
---------------------------------------------------------------------------
\3\ The [* * *] suggestion that the requirement to provide
options counseling [including abortion counseling] should not apply
to employees of a grantee who object to providing such counseling on
moral or religious grounds, is likewise rejected [* * *] [S]uch 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 (emphasis added). 65 FR 41270 (July 3, 2000)
[codified at 42 CFR 59 (2008)]; see also Letter from Secretary Tommy
G. Thompson to Hon. W.F. Tauzin, September 24, 2002.
Table I--Affected Entities
------------------------------------------------------------------------
Number of
Health care entity entities
------------------------------------------------------------------------
Hospitals (less than 100 beds) \1\......................... 2,403
Hospitals (100-200 beds) \4\............................... 1,129
Hospitals (200-500 beds) \4\............................... 1,160
Hospitals (more than 500 beds) \4\......................... 244
Nursing Homes (less than 50 beds) \2\...................... 2,388
Nursing Homes (50-99 beds) \5\............................. 5,819
Nursing Homes (99-199 beds) \5\............................ 6,877
Nursing Homes (more than 200 beds) \5\..................... 1,037
Physicians Offices \3\..................................... 234,200
Offices of Other Health CarePractitioners \6\ \4\.......... 115,378
Outpatient Care Centers \6\ \5\............................ 26,901
Medical and Diagnostic Laboratories \6\.................... 11,856
Home Health Care Services \6\.............................. 20,184
Pharmacies (chain and independent) \6\..................... 58,109
Dental Schools \7\......................................... 56
Medical Schools (Allopathic) \4\........................... 125
Medical Schools (Osteopathic) \4\.......................... 20
Nursing Schools (Licensed practical) \8\................... 1,138
Nursing Schools (Baccalaureate) \11\....................... 550
Nursing Schools (Associate degree) \11\.................... 885
Nursing Schools (Diploma) \11\............................. 78
Occupational Therapy Schools \4\........................... 142
Optometry Schools \4\...................................... 17
Pharmacy Schools \4\....................................... 92
Podiatry Schools \4\....................................... 7
Public Health Schools \4\.................................. 37
Residency Programs (accredited) \9\........................ 8,494
Health Insurance Carriers and 3rd-Party Administrators \10\ 4,578
Grant awards \11\.......................................... 76,088
Contractors \12\........................................... 4,245
State and territorial governments.......................... 57
------------
Total.................................................. 584,294
------------------------------------------------------------------------
\1\ 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.
\2\ Nursing Home Data Compendium, 2007 edition. U.S. Dept. of Health and
Human Services, Centers for Medicaid and Medicare Services.
\3\ NPRM: Modification to Medical Data Code Set Standards to Adopt ICD-
10-CM and ICD-10-PCS.
\4\ 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).
\5\ 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).
[[Page 50281]]
\6\ 2005 NCPA-Pfizer Digest: Total, Prescription Sales Increase At
Nation's Independent Pharmacies. National Community Pharmacies
Association Press Release, May 12, 2005.
\7\ 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.
\8\ 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.
\9\ 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.
\10\ U.S. Department of Labor, Bureau of Labor Statistics, National
Occupational Employment and Wage Estimates, May 2007.
\11\ HHS Grants Statistics, 2007. Available at http://www.hhs.gov/
grantsnet.
\12\ General Services Administration (estimated).
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.
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 584,294 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, assuming that the recipient chooses to have a high-level employee
such as a Chief Executive certify on its behalf, the cost associated
with the act of certification is $42.5 million (584,294 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 73,088 grant awards 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 (77,333 entities x 1
hour x $30).
Indirect costs associated with the certification requirement might
include costs for such actions as staffing/scheduling changes and
internal reviews to assess compliance. There is insufficient data to
estimate the number of funding recipients not currently compliant with
the Church Amendments, PHS Act Sec. 245, or the Weldon Amendment.
However, 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. We
specifically request comment on this assumption.
The total quantifiable costs of the proposed regulation, if
finalized, are estimated to be $44.5 million each year.
Regulatory Flexibility Act
HHS has examined the economic implications of this proposed 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 (RFA) requires agencies to
analyze regulatory options that would lessen the economic effect of the
rule on small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, by virtue of either nonprofit status or having
revenues of $6 million to $29 million in any 1 year. Individuals and
States are not included in the definition of a small entity. While the
proposed rule will affect a number of small entities, we preliminarily
conclude that the costs of compliance are not economically significant
(see discussion above). Moreover, in accordance with subsection 88.5(e)
below, physicians, physician offices, and other health care
practitioners participating in Medicare Part B or who are sub-
recipients assisting in the implementation of a State Medicaid program
are not subject to the written certification requirement. Thus, we
conclude that this proposal, if finalized, 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.
Executive Order 13132--Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has federalism
implications.
All three acts enforced in this proposed 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, they do so only to the extent that States
and local governments would be required to submit certifications of
compliance with the statutes and these regulations, 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 proposed certification requirement to be negligible.
The Department will consult with States and local governments to
seek ways to minimize any burden imposed on the States and local
governments by these proposed regulations, consistent with meeting the
Department's objectives of ensuring: (1) Knowledge of the obligations
imposed, and the rights and protections afforded, by these federal
nondiscrimination provisions; and (2) compliance with the
nondiscrimination provisions.
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
[[Page 50282]]
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 approximately $130 million. The Department has determined
that this proposed rule would not constitute a significant rule under
the Unfunded Mandates Reform Act.
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.
These regulations will not have an impact on family well-being, as
defined in the Act.
Paperwork Reduction Act of 1995
This proposed rule does not create any new 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.
Therefore, under the Church Amendments, 42 U.S.C. 300a-7, Public
Health Service Act Sec. 245, 42 U.S.C. 238n, and the Weldon Amendment,
Consolidated Appropriations Act, 2008, Pub. L. No. 110-161, Div. G,
Sec. 508(d), 121 Stat. 1844, 2209, the Department of Health and Human
Services proposes to add 45 CFR 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.
Authority: 42 U.S.C. 300a-7, 42 U.S.C. 238n, Pub. L. 120-161,
Div. G, section 508(d), 121 Stat. 1884, 2209, 31 U.S.C. 6306, 41
U.S.C. 253, 40 U.S.C. 471, 42 U.S.C. 1395w-22(j)(3)(B), and 42
U.S.C. 1396u-2(b)(3).
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 No. 110-
161, Div. G, section 508(d), 121 Stat. 1844, 2209. These statutory
provisions protect the rights of health care entities/entities, both
individuals and institutions, to refuse to perform health care services
to which they may object for religious, moral, ethical, or other
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,
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/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 includes employees, volunteers, trainees, and other
persons whose conduct, in the performance of
[[Page 50283]]
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.
Sec. 88.3 Applicability.
(a) The Department of Health and Human Services is required to
comply with Sec. 88.4(a), (b)(1), and (d)(1).
(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.
(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.
(d) Any State or local government that receives federal financial
assistance is required to comply with Sec. Sec. 88.4(a) and 88.5.
(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).
(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.
(2) In addition to complying with the provisions set forth in Sec.
88.4(c)(1), 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(a)(2).
(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.
(2) In addition to complying with the provisions set forth in
paragraph (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. 88.4(d)(2).
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 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
[[Page 50284]]
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 its
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 in a separate writing,
signed by the sub-recipients' officer or other person authorized to
bind the sub-recipient. Certifications shall be made by an officer or
other individual authorized to bind the recipient or sub-recipient. All
certifications shall be addressed directly to the Department;
recipients are required to submit their certifications directly to the
Department. Recipients shall 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 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 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 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) The certification. 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 discriminate on the basis of an entity's past involvement
in, or refusal to assist in the performance of, the practices of
abortion or sterilization, and will not require involvement in
procedures that violate an individual's conscience as part of any
part of any health service program, in accord with all applicable
sections of 45 CFR part 88.
I further certify that the recipient acknowledges that any
violation of these certifications shall be grounds for 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. 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, contract, grant under a contract, memorandum of
understanding or other funding instrument 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 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) The certification. 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 discriminate on the basis of an entity's past
involvement in, or refusal to assist in the performance of, the
practices of abortion or sterilization, and will not require
involvement in procedures that violate an individual's conscience as
part of any part of any health service program, in accord with all
applicable sections of 45 CFR part 88.
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 shall be grounds for termination by the Department of
the recipient's grant, cooperative agreement,
[[Page 50285]]
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. 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
paragraphs (e)(1) through (3) of this section, the following
individuals or organizations shall not be required to comply with the
written certification requirement 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 B of the
Medicare program, when such individuals or organizations are sub-
recipients of Department funds through a Medicare Advantage plan; or
(3) A sub-recipient of Department funds through a State Medicaid
program.
Dated: August 20, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8-19744 Filed 8-21-08; 2:00 pm]
BILLING CODE 4150-28-P