[Federal Register Volume 74, Number 45 (Tuesday, March 10, 2009)]
[Proposed Rules]
[Pages 10207-10211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5067]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 88
RIN 0991-AB49
Rescission of the Regulation Entitled ``Ensuring That Department
of Health and Human Services Funds Do Not Support Coercive or
Discriminatory Policies or Practices in Violation of Federal Law'';
Proposal
AGENCY: Office of the Secretary, HHS.
ACTION: Proposed rule.
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SUMMARY: The Department of Health and Human Services proposes to
rescind the December 19, 2008 final rule entitled ``Ensuring That
Department of Health and Human Services Funds Do Not Support Coercive
or Discriminatory Policies or Practices in Violation of Federal Law.''
The Department believes it is important to have an opportunity to
review this regulation to ensure its consistency with current
Administration policy and to reevaluate the necessity for regulations
implementing the Church Amendments, Section 245 of the Public Health
Service Act, and the Weldon Amendment.
DATES: Submit written or electronic comment on the regulatory changes
proposed by this document by April 9, 2009.
ADDRESSES: In commenting, please refer to ``Rescission Proposal.'' To
better manage the comment process, we will not 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
[email protected]. 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 ``Rescission Proposal.''
[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: Rescission
Proposal Comments, Hubert H. Humphrey Building, 200 Independence
Avenue, SW., Room 716G, 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: Rescission Proposal Comments, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Room 716G, 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 716G, 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 an extra copy of the documents being filed.)
Inspection of Public Comments: All comments received before the
close of
[[Page 10208]]
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 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 Service (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 use communications software and modem
to call (202) 512-1661; type swais, then login as guest (no password
required).
FOR FURTHER INFORMATION CONTACT: Mahak Nayyar, (240) 276-9866, Office
of Public Health and Science, Department of Health and Human Services,
Room 716G, Hubert E. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201.
SUPPLEMENTARY INFORMATION:
I. Background
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.
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 or assistance in the performance of
sterilization procedures or abortions, if it would be contrary to the
religious beliefs or moral convictions of such personnel.
The second conscience provision in the Church Amendments, 42 U.S.C.
300a-7(c)(1), prohibits any entity that receives a grant, contract,
loan, or loan guarantee under certain Department-implemented statutes
from discriminating against any physician or other health care
personnel in employment, promotion, termination of employment, or the
extension of staff or other privileges because the individual
``performed or assisted in the performance of a lawful sterilization
procedure or abortion, because he refused to perform or assist in the
performance of such a procedure or abortion on the grounds that his
performance or assistance in the performance of the procedure or
abortion would be contrary to his religious beliefs or moral
convictions, or because of his religious beliefs or moral convictions
respecting sterilization procedures or abortions.''
The third conscience provision, contained in 42 U.S.C. 300a-
7(c)(2), prohibits any entity that receives a grant or contract for
biomedical or behavioral research under any program administered by the
Department from discriminating against any physician or other health
care personnel in employment, promotion, termination of employment, or
extension of staff or other privileges ``because he performed or
assisted in the performance of any lawful health service or research
activity, because he refused to perform or assist in the performance of
any such service or activity on the grounds that his performance or
assistance in the performance of such service or activity would be
contrary to his religious beliefs or moral convictions, or because of
his religious beliefs or moral convictions respecting any such service
or activity.''
The fourth conscience provision, 42 U.S.C. 300a-7(d), provides that
``[n]o individual shall be required to perform or assist in the
performance of any part of a health service program or research
activity funded in whole or in part under a program administered by
[the Department] if his performance or assistance in the performance of
such part of such program or activity would be contrary to his
religious beliefs or moral convictions.''
The final conscience provision contained in the Church Amendments,
42 U.S.C. 300a-7(e), prohibits any entity that receives a grant,
contract, loan, loan guarantee, or interest subsidy under certain
Departmentally implemented statutes from denying admission to, or
otherwise discriminating against, ``any applicant (including applicants
for internships and residencies) for training or study because of the
applicant's reluctance, or willingness, to counsel, suggest, recommend,
assist, or in any way participate in the performance of abortions or
sterilizations contrary to or consistent with the applicant's religious
beliefs or moral convictions.''
Public Health Service Act Sec. 245 [42 U.S.C. 238n]
Enacted in 1996, section 245 of the Public Health Service Act (PHS
Act) prohibits the federal government and any State or local government
receiving federal financial assistance from discriminating against any
health care entity on the basis that the entity (1) ``Refuses to
undergo training in the performance of induced abortions, to require or
provide such training, to perform such abortions, or to provide
referrals for such training or such abortions;'' (2) refuses to make
arrangements for such activities; or (3) ``attends (or attended) a
post-graduate physician training program, or any other program of
training in the health professions, that does not (or did not) perform
induced abortions or require, provide, or refer for training in the
performance of induced abortions, or make arrangements for the
provision of such training.'' For the purposes of this protection, the
statute defines ``financial assistance'' as including, ``with respect
to a government program,'' ``governmental payments provided as
reimbursement for carrying out health-related activities.'' In
addition, PHS Act
[[Page 10209]]
Sec. 245 requires that, in determining whether to grant legal status to
a health care entity (including a State's determination of whether to
issue a license or certificate), the federal government and any State
or local government receiving federal financial assistance shall deem
accredited any 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
The Weldon Amendment, originally adopted as section 508(d) of the
Labor-HHS Division (Division F) of the 2005 Consolidated Appropriations
Act, Public Law 108-447, 118 Stat. 2809, 3163 (Dec. 8, 2004), has been
readopted (or incorporated by reference) in each subsequent HHS
appropriations act. Title V of the Departments of Labor, Health and
Human Services, and Education, and Related Agencies Appropriations Act,
2006, Public Law 109-149, Sec. 508(d), 119 Stat. 2833, 2879-80 (Dec.
30, 2005); Revised Continuing Appropriations Resolution of 2007, Public
Law 110-5, Sec. 2, 121 Stat. 8, 9 (Feb. 15, 2007); Consolidated
Appropriations Act, 2008, Public Law 110-161, Div. G, Sec. 508(d), 121
Stat. 1844, 2209 (Dec. 26, 2007); Consolidated Security, Disaster
Assistance, and Continuing Appropriations Act, 2009, Public Law 110-
329, Div. A, Sec. 101, 122 Stat. 3574, 3575 (Sept. 30, 2008). The
Weldon Amendment provides that ``[n]one of the funds made available in
this Act [making appropriations for the Departments of Labor, Health
and Human Services, and Education] may be made available to a Federal
agency or program, or to a State or local government, if such agency,
program, or government subjects any institutional or individual health
care entity to discrimination on the basis that the health care entity
does not provide, pay for, provide coverage of, or refer for
abortions.'' It also defines ``health care entity'' to include ``an
individual physician or other health care professional, a hospital, a
provider-sponsored organization, a health maintenance organization, a
health insurance plan, or any other kind of health care facility,
organization, or plan.''
Rulemaking
No statutory provision requires the promulgation of rules to
implement the requirements of the Church Amendments, Public Health
Service (PHS) Act Sec. 245, and the Weldon Amendment. Nevertheless, on
August 26, 2008, the Department exercised its discretion and issued a
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'' (73 FR 50274). Citing concerns
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, the Department concluded that regulations were necessary
in order to (1) Educate the public and health care providers on the
obligations imposed, and protections afforded, by federal law; (2) work
with State and local governments and other recipients of funds from the
Department to ensure compliance with the nondiscrimination requirements
embodied in the 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 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 inclusive, tolerant environment in the health care
industry than may currently exist.
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, commented on the
proposed rule. 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, the rule's relationship to
Title VII of the Civil Rights Act and other statutes and protections,
what services are covered by the rule, whether health care workers
might use the regulation to discriminate against patients, what
significant implementation issues could be associated with the rule,
legal arguments, the cost impacts and the public health consequences of
the rule.
On December 19, 2008, the Department issued a final rule (73 FR
78072). The Department saw a need to balance the rights of patients in
obtaining legal health care services against the statutory rights of
providers in the context of federally funded entities not to be
discriminated against based on a refusal to participate in a service to
which they have objections. Thus, the Department imposed an additional
certification requirement by specifically including a 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.
The final rule went into effect on January 20, 2009, except that
Department components have been given discretion to phase in the
written certification requirement by no later than the beginning of the
next federal fiscal year following the effective date of the
regulation. Furthermore, the certification requirement is not effective
pending completion of the information collection process under the
Paperwork Reduction Act. The 60-day comment period on the information
collection expired on February 27, 2009, and OMB approval for the
information collection has not yet been sought.
II. Proposed Rule
The Department is proposing to rescind in its entirety the final
rule entitled ``Ensuring That Department of Health and Human Services
Funds Do Not Support Coercive or Discriminatory Policies or Practices
in Violation of Federal Law,'' published in the Federal Register on
December 19, 2008 (73 FR 78072, 45 CFR Part 88). Commenters asserted
that the rule would limit access to patient care and raised concerns
that individuals could be denied access to services, with effects felt
disproportionately by those in rural areas or otherwise underserved.
The Department believes that the comments on the August 2008 proposed
rule raised a number of questions that warrant further careful
consideration. It is important that the Department have the opportunity
to review this regulation to ensure its consistency with current
Administration policy. Accordingly, we believe it would benefit the
Department to review this rule, accept further comments, and reevaluate
the necessity for regulations implementing the statutory requirements.
Thus, the Department is proposing to rescind the
[[Page 10210]]
December 19, 2008 final rule, and we are soliciting public comment to
aid our consideration of the many complex questions surrounding the
issue and the need for regulation in this area.
III. Statutory Authority
The Secretary proposes to rescind the December 19, 2008 final rule
entitled ``Ensuring That Department of Health and Human Services Funds
Do Not Support Coercive or Discriminatory Policies or Practices in
Violation of Federal Law.'' As discussed above, the Church Amendments,
section 245 of the PHS Act, and the Weldon Amendment require, among
other things, that the Department and recipients of Department funds
(including State and local governments) refrain from discriminating
against institutional and individual health care entities for their
participation in certain medical procedures or services, including
certain health services, or research activities funded in whole or in
part by the federal government. No statutory provision, however,
requires promulgation of a rule such as that published on December 19,
2008. This proposed rule is being issued pursuant to the authority of 5
U.S.C. 301, which empowers the head of an Executive department to
prescribe regulations ``for the government of his department, the
conduct of his employees, the distribution and performance of its
business, and the custody, use, and preservation of its records,
papers, and property.''
IV. Request for Comment
The Department, in order to determine whether or not to rescind the
final rule in part or in its entirety, seeks comments. In particular,
the Department seeks the following:
1. Information, including specific examples where feasible,
addressing the scope and nature of the problems giving rise to the need
for federal rulemaking and how the current rule would resolve those
problems;
2. Information, including specific examples where feasible,
supporting or refuting allegations that the December 19, 2008 final
rule reduces access to information and health care services,
particularly by low-income women;
3. Comment on whether the December 19, 2008 final rule provides
sufficient clarity to minimize the potential for harm resulting from
any ambiguity and confusion that may exist because of the rule; and
4. Comment on whether the objectives of the December 19, 2008 final
rule might also be accomplished through non-regulatory means, such as
outreach and education.
V. 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 single sector of the economy in a
material way, adversely affecting competition, or adversely affecting
jobs. This proposed rule is not significant under these economic
standards. However, under Executive Order 12866, a regulation is also
considered a significant regulatory action if it raises novel legal or
policy issues. Because HHS previously determined that the December 19,
2008 final rule was a significant regulatory action under this
standard, HHS will assume that the proposed rescission of the December
19, 2008 final rule is also a significant regulatory action.
The December 19, 2008 final rule estimated the quantifiable costs
associated with the certification requirements of the proposed
regulation to be $43.6 million each year. Rescinding the rule would
therefore result in a cost savings of $43.6 million each year to the
health care industry.
Regulatory Flexibility Act
HHS has examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (RFA). If a rule has a
significant economic burden on a substantial number of small entities,
the 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. The position of the Department has long
been that the RFA requirements for regulatory flexibility analysis only
apply to rules that create significant adverse impacts on small
entities. Rescission of the final rule may create positive impacts on
small entities by removing any burdens imposed by that rule.
Accordingly, we certify that this proposed rule will not have a
significant effect 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. This proposed rule would not require additional steps to
meet the requirements of Executive Order 13132 because it removes any
burden imposed by the December 19, 2008 final rule.
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 analysis before any rulemaking if
the rule includes a ``Federal mandate that may result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year.'' The current inflation-adjusted
statutory threshold is approximately $130 million. The Department has
determined that this proposed rule would not constitute a significant
rule under the Unfunded Mandates Reform Act, because it would rescind
rather than impose mandates.
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.
This regulation will not have an impact on family well-being, as
defined in the Act, because it affects only regulated entities and
eliminates costs that would otherwise be imposed on those entities.
Paperwork Reduction Act of 1995
This proposed rule does not create any new requirements under the
Paperwork Reduction Act of 1995. Instead, it proposes to eliminate
[[Page 10211]]
requirements that would be imposed by the final rule issued on December
19, 2008. The 60-day comment period on the information collection
requirements of the December 19, 2008 final rule expired on February
27, 2009, and OMB approval for the information collection requirements
has not yet been sought.
List of Subjects in 45 CFR Part 88
Abortion, Civil rights, Colleges and universities, Employment,
Government contracts, Government employees, Grant programs, Grants
administration, Health care, Health insurance, Health professions,
Hospitals, Insurance companies, Laboratories, Medicaid, Medical and
dental schools, Medical research, Medicare, Mental health programs,
Nursing homes, Public health, Religious discrimination, Religious
liberties, Reporting and recordkeeping requirements, Rights of
conscience, Scientists, State and local governments, Sterilization,
Students.
Dated: March 5, 2009.
Charles E. Johnson,
Acting Secretary.
PART 88--[REMOVED AND RESERVED]
Therefore, under 5 U.S.C. 301, the Department of Health and Human
Services proposes to remove and reserve 45 CFR part 88.
[FR Doc. E9-5067 Filed 3-6-09; 11:15 am]
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