```

[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]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4150-28-P
```