HHS Protection of Conscience Regulation (2008-2011)
U.S. Department of Health and Human Services
Ensuring That Department of Health and Human Services Funds Do Not
Support Coercive or Discriminatory Policies or Practices in Violation of
Federal Law
Comment by HHS on Final Rule (2008)
Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008
/ Rules and Regulations:
Part VI,
78072-78101.
Note:
This submission refers to a regulation issued in December, 2008 by the Bush Administration that was eviscerated by the Obama Administration and re-issued in February, 2011. [See current regulation.]
Headings/comments in [square brackets]
added by Project Administrator for convenience.
III. Legal Authority
On the basis of the following statutory authority, the Secretary promulgates
these regulations, requiring certification of compliance with
anti-discrimination statutes.
5 U.S.C. 301 empowers the head of an
Executive department to prescribe regulations ''for the government of his
department, the conduct of its employees, the distribution and performance
of its business, and the custody, use, and preservation of its records,
papers, and property.''
The Church
Amendments, 42 U.S.C.300a-7 (2000), prohibit recipients of
Department funding under the PHS Act and several other statutes from
discriminating against employees and others who participate in health
service programs or research activities funded in whole or part by the
Department who refuse to perform certain medical services, including
sterilization, abortion, or research activities because of religious or
moral beliefs.
Specifically, section 300a-7(c)(1)(A) and (B) provides that recipients
may not discriminate in the employment of or the extension of staff
privileges to any health care professional because he refused, because of
his religious beliefs or moral convictions, to perform or assist in the
performance of any sterilization or abortion procedures.
Section 300a-7(d) provides that no individual shall be required to
perform or assist in the performance of any health service program or
research activity funded in whole or part by the Department contrary to his
religious beliefs or moral convictions.6
PHS Act § 245, 42
U.S.C. 238n (1996),prohibits the Federal government and any State or
local government that receives federal financial assistance from
discriminating against any healthcare entity (including both individual and
institutional providers) on the basis that, among other things, the entity
refuses to (1) receive training in abortion; (2) provide abortion
training;(3) perform abortions; (4) provide referral for such abortions; and
(5) provide referrals for abortion training.42 U.S.C. 238n(a).
The Weldon Amendment,
Consolidated Appropriations Act, 2008,Public Law 110-161, § 508(d), 121
Stat.1844, 2209 (2008), prohibits a federal agency or program, or any State
or local government from receiving Department funds if such agency, program,
or government subjects any institutional or individual health care entity to
discrimination on the basis that the health care entity does not provide,
pay for, provide coverage of, or refer for abortions. These statutory
provisions require that the Department and recipients of Department funds
refrain from discriminating against institutional and individual health care
entities for their participation or refusal to participate in certain
medical services or research activities funded by the federal government.
The Department has authority to promulgate regulations to enforce these
prohibitions. Finally, the Department also has the legal authority to
require that recipients certify their compliance with these proposed
requirements and to require their subrecipients to likewise certify their
compliance with these proposed requirements.
We respond to the Comment on the Department's legal authority to
promulgate these regulations in section H (General Comments) of the Comments
section
above.
IV. Section-by-Section Description of the Final Rule
Section 88.1 Purpose
Proposed Rule: In the proposed rule, the ''Purpose'' section set
forth the objective that this final rule provides for the implementation and
enforcement of federal nondiscrimination statutes protecting the conscience
rights of health care entities. It also states that the statutory provisions
and regulations contained in this Part are to be interpreted and implemented
broadly to effectuate these protections.
The Department received no
Comments on this section.
Final Rule: The Department adopts this provision as recommended in
the proposed rule without modification.
Section 88.2 Definitions
Assist in the Performance
Proposed Rule: The Department, in considering how to interpret the
term' 'assist in the performance,'' sought to provide broad protection for
individuals. At the same time, the Department sought to guard against
potential abuses of these protections by limiting the definition of ''assist
in the performance'' to only those individuals who have a reasonable
connection to the procedure, health service or health service program, or
research activity to which they object.
Therefore, the Department proposed
to interpret this term broadly, as encompassing individuals who are members
of the workforce of the Department-funded entity performing the
objectionable procedure. When applying the term ''assist in the
performance'' to members of an entity's workforce, the Department proposed
that the term be limited to participation in any activity with a reasonable
connection to the objectionable procedure, including referrals, training,
and other arrangements for the procedure, health service, or research
activity. For example, an operating room nurse would assist in the
performance of surgical procedures; an employee whose task it is to clean
the instruments used in a particular procedure would also be considered to
assist in the performance of the particular procedure under the proposed
rule.
The Department responds to Comments on the proposed definition of this
term
above.
Final Rule: The Department adopts the above definition as
proposed.
Health Care Entity/Entity
Proposed Rule: While both PHS Act§ 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 § 245 defines ''healthcare entity'' as ''includ[ing] an
individual physician, a postgraduate physician training program, and a
participant in a program of training in the health professions.'' As a
matter of statutory construction as well as long standing Departmental
interpretation, the definition of ''health care entity'' in PHS Act § 245
also encompasses institutional entities, such as hospitals and other
entities.
The Weldon Amendment defines the term ''healthcare entity'' as
''includ[ing] an individual physician or other healthcare professional, a
hospital, a provider sponsored organization, a health maintenance
organization, a health insurance plan, or any other kind of health care
facility, organization, or plan.''
The Church Amendment does not define the term ''entity,'' and does not
use the term ''health care entity.'' In keeping with the definitions inPHS
Act § 245 and the Weldon Amendment, the Department proposed to define
''health care entity'' to include the specifically mentioned types of
individuals and organizations from the two statutes, as well as other types
of entities referenced in the Church Amendments.
The Department responds to Comments on the proposed definition of this
term above.
Final Rule: The Department adopts the proposed definition without
modification. It is important to note that the Department does not intend
for this to be a comprehensive list of relevant types of individuals and
organizations for purposes of the regulation, but merely a list of examples.
Health Service/Health
Service Program
Proposed Rule: One of the provisions in the Church Amendments uses
the term ''health service,'' another uses the term ''health service
program.'' The Church Amendments do not define these terms, nor does the
Public Health Service Act define ''health service program.'' In developing
an appropriate definition for ''health service program,'' the proposed rule
looked at the Social Security Act.
Section 1128B(f)(1) of the Social Security Act, 42 U.S.C. 1320a-7b(f)(1),
defines a similar term, ''federal health care program'', as ''any plan or
program that provides health benefits, whether directly, through insurance,
or otherwise, which is funded directly, in whole or in part, by the United
States Government.'' Building on this broad definition, it was proposed that
the term ''healthservice program'' should be understood to include an
activity related in any way to providing medicine, health care, or any other
service related to health or wellness, including programs where the
Department provides care directly (e.g., Indian Health Service); programs
where grants pay for the provision of health services (e.g., Administration
for Children and Families programs such as the Unaccompanied Refugee Minor
and the Division of Unaccompanied Children Services programs and HRSA
programs such as community health centers); programs where the Department
reimburses another entity that provides care (e.g., Medicare); and health
benefit programs where federal funds are used to provide access tohealth
coverage (e.g., SCHIP, Medicaid, and Medicare Advantage).
The Department responds to Comments on the proposed definition of this
term above.
Final Rule: Upon further reflection, the Department has determined
that the meaning of the term ''health service'' is self-evident, and so we
do not adopt a definition for ''health service'' in this final rule.
Final Rule: The Department adopts the above definition without
modification.
Individual
Proposed Rule: For the purposes of the new proposed part, the
proposed rule defined ''individual'' to mean a member of the workforce (see
definition of ''workforce'' below) of an entity or
health care entity. One conscience clause of the Church Amendments, 42U.S.C.
300a-7(d), provides that ''[n]o individual shall be required to perform or
assist in the performance of any part of a health service program or
research activity funded in whole or in part under a program administered by
the Secretary of Health, Education and Welfare [Secretary of Health and
Human Services] if his performance or assistance in the performance of such
part of such program or activity would be contrary to his religious beliefs
or moral convictions.'' (Emphasis added.)
The Department responds to
Comments on the proposed definition of this ter above.
Final Rule: The Department adopts the above definition as
proposed.
Instrument
Proposed Rule: The proposed rule uses the term ''instrument'' to mean
the variety of means by which the Department conveys funding and resources
to organizations, including: grants, cooperative agreements, contracts,
grants under a contract, and memoranda of understanding. The proposed
definition of ''instrument'' was intended to include all means by which the
Department conveys funding and resources.
No Comments were received on the
definition of this term.
Final Rule: The Department adopts the above definition without
modification.
Recipient
Proposed Rule: The proposed rule defined this term to mean any entity
that receives Department funds directly.
The Department responds to Comments on the proposed definition of this
term.
Final Rule: The Department adopts this definition as proposed
Sub-recipient
Proposed Rule: The proposed rule defined this term to mean any entity
that receives Department funds indirectly through a recipient or
subrecipient.
The Department responds to Comments on the proposed definition of this
term above.
Final Rule: The Department adopts this definition as proposed.
Workforce
Proposed Rule: In the proposed rule we defined the term ''workforce''
as including employees, volunteers, trainees, and other persons whose
conduct, in the performance of work for an entity, is under the control
orauthority of such entity, whether or notthey are paid by the
Department-funded entity. The definition was drawn from the ''Administrative
Data Standards and Related Requirements'' rules implementing the Health
Insurance Portability and Accountability Act (HIPAA), 45 CFR parts 160, 162,
and164 (2006) at 45 CFR 160.103.
In keeping with this definition, persons
and organizations under contract with an entity, if they are under the
control or authority of the entity, would be considered members of the
entity's workforce.
The Department responds to Comments on the proposed definition of this
term
above.
Final Rule: In response to public Comments on this issue, we have
provided an exclusive definition of the term ''workforce'' by changing'
'includes'' to ''means'' in the definition.
In defining both ''individual'' and ''workforce,'' the Department
promulgates definitions that provide a reasonable scope for the natural
persons protected by 42 U.S.C. 300a-7(d) and the corresponding provisions of
these regulations. By limiting the scope of persons protected by these
regulations to those who are under the control or authority of an entity
that implements a health service program or research activity funded in
whole or in part under a program administered by the Department, we provide
the bright line necessary for Department-funded entities subject to the
applicable Church Amendment provisions to set policies or otherwise take
steps to secure conscience protections within the workplace and, thus, to
comply with the Church Amendment and these regulations.
As indicated in the proposed rule-and consistent with the scope of the
Church Amendments, which include physicians and other health care providers
that have privileges with an entity receiving funding from the Department-we
intended the concept of ''workforce'' to include physicians and other health
care providers who have privileges at the entity funded by the Department.
After publication of the proposed rule, it came to the Department's
attention that the language of the ''workforce'' definition may not be clear
on this issue. Accordingly, to ensure clarity on this point, we are revising
the definition of ''workforce'' by adding at the end ''or health care
providers holding privileges with the entity''.
Section 88.3 Applicability
Proposed Rule: The ''Applicability'' section of the proposed rule
directs individuals and entities receiving funds from the Department to the
appropriate sections of proposed section 88.4 that set forth the relevant
requirements, drawn from the three statutes that form the basis of this
regulation, that are applicable to them and also directed to the provisions
regarding certifications that the various recipients of federal monies must
provide.
Final Rule: In this final rule, we have included a
technical correction in section 88.3 clarifying that educational
institutions, teaching hospitals, and programs for the training of health
care professionals or health care workers shall comply with section
88.4(c)(2),which prohibits discrimination against or denial of admission to
applicants' 'because of reluctance or willingness to counsel, suggest,
recommend, assist, or in any way participate in the performance of abortions
or sterilizations contrary to or consistent with the applicant's religious
beliefs or moral convictions'' in accordance with PHS Act § 245. 42 U.S.C.
300a-7(e).Apart from this change, we have adopted this provision as
recommended in the proposed rule.
Section 88.4
Requirements and Prohibitions
Proposed Rule: The ''Requirementsand Prohibitions'' section in the
proposed rule explains the obligations that the Church Amendments, PHS Act§
245, and the Weldon Amendment impose on entities which receive funding from
the Department, depending on the type of entity and the program or statute
under which the funding is received. These provisions are taken from the
relevant statutory language and make up the elements of the certification
provided by the entities. The proposed rule states that we intend for the
requirements and prohibitions to be interpreted using the definitions
contained in section 88.2.
Final Rule: The final rule adopts this
provision without change.
Section 88.5
Written Certification of Compliance
Proposed Rule: In the ''WrittenCertification of Compliance'' section
of the proposed rule, the Department proposed to require certain recipients
and sub-recipients of Department funds to certify compliance with the Church
Amendments, PHS Act § 245, and the Weldon Amendment, as applicable, and to
provide for the affected recipients and sub-recipients requirements for
collecting, maintaining, and submitting written certifications.
We are
concerned that there is a lack of knowledge on the part of States, local
governments, and the health care industry of the rights of health care
entities created by, and the corresponding obligations imposed on the
recipients of certain federal funding by, the nondiscrimination provisions.
Under the proposed rule, recipients of federal funds would be required to
submit their certifications directly to the Department as part of the
instrument or in a separate writing signed by the recipients' officer or
other person authorized to bind the recipient. They would also be required
to collect and maintain certifications by sub-recipients who receive
Department funds through them.
The proposed regulation would require that entities certify in writing
that they will operate in compliance with the Church Amendments, PHS Act§
245, and the Weldon Amendment as applicable. Certification provides a
demonstrable way of ensuring that the recipients of such funding know of,
and attest that they will comply with, the applicable nondiscrimination
provisions.
Sub-recipients of federal funds-entities that will receive federal funds
indirectly through another entity (a recipient or other sub-recipient)-would
be required to provide certification as set out in the ''Subrecipient''
subsection of the' 'Certification of Compliance'' section, and submit them
to the recipients through which they receive Department funds for
maintenance.
Although it would be collected and maintained by the recipient, this
certification by subrecipients would be a certification addressed to the
Department, not to the recipients collecting the certification. Recipients
would be expected to comply with requirements for retention of and access to
records set forth in 45 CFR74.53.
While all recipients and subrecipients of Department funds are required
to comply with the Church Amendments, PHS Act § 245, and the Weldon
Amendment, as applicable, section 88.5(e), as proposed, would contain
several important exceptions to the proposed requirement to provide the
written certification, including individual physicians, physician offices,
other health care practitioners, and other participants in Part B of the
Medicare program; (2) physicians, physician offices, or other health care
practitioners participating in Part C of the Medicare program, when such
individuals or organizations are subrecipients of Department funds through a
Medicare Advantage plan; and (3) subrecipients of State Medicaid programs
(i.e., any entity that is paid for services by the State Medicaid program).
While other providers participating in the Medicare program as well as
State Medicaid programs would be required to submit written certification of
compliance to the Department, the large number of entities included in the
categories of providers listed above (e.g., individual physicians, physician
offices, other health care practitioners, and subrecipients of State
Medicaid programs) would have posed significant implementation hurdles for
Departmental components and programs. Furthermore, the Department believed
that, due primarily to their generally smaller size, the excepted categories
of recipients and subrecipients of Department funds in the above categories
would be less likely to encounter the types of issues sought to be addressed
in this regulation.
However, we noted in the proposed rule that excepted providers may become
subject to the proposed written certification requirement by receiving
Department funds under a separate agency or program. For example, under the
proposed rule, a physician office participating in Medicare Part B may
become subject to the proposed written certification requirement by
receiving Department funds to conduct clinical research. We noted, however,
that the State Medicaid programs would be responsible for ensuring the
compliance of their sub-recipients as part of ensuring that the State
Medicaid program is operated consistent with applicable nondiscrimination
provisions.
Final Rule: Partly in Response to suggestions received in Response
to solicitation of public Comment on this issue (see the Department
Responses to the Comments on the proposed certification requirement above),
HHS has determined to make further exceptions to the certification
requirements in section 88.5 in the final rule.
Exceptions from the written certification requirement are included for
Departmental grant programs whose purpose is unrelated to health care
provision, including economic assistance, and which do not involve medical
research or the involvement of health care providers, and which are unlikely
to involve referral for provision of health care. These programs often
involve funding to States and other governments for non-health care
purposes, and/or cash assistance or vouchers, rather than direct services by
a funded entity, to individuals. These programs are unlikely to involve
Department funds being used for medical research, the participation of
health care providers or referral to health care providers. As a
consequence, these programs are also unlikely to encounter the circumstances
contemplated by this regulation, and therefore the assurance of compliance
represented by a certification is not considered necessary by the Department
for such programs.
Programs excepted under this provision include certain current programs
administered by the Administration for Children and Families, including
Low-Income Home Energy Assistance Program, Assets for Independence, the
Child Care and Development Fund, Job Opportunities for Low-Income
Individuals, Mentoring Children of Prisoners, and programs overseen by the
Office of Child Support Enforcement, as well as certain current programs
administered by the Administration on Aging. Finally, an exception to the
written certification requirement of section 88.5 has been included for
Indian Tribes and Tribal Organizations when contracting with the Indian
Health Service under the Indian Self-Determination and Education Assistance
Act.
As stated in the proposed rule, individual Department components have
been tasked with determining how best to implement the written certification
requirements set out in this regulation in a way that ensures efficient
program operation. To this end, Department components have been given
discretion to phase in the written certification requirement by no later
than the beginning of the next federal fiscal year following the effective
date of the regulation.
Finally, we have reorganized the wording of the written certifications in
section 88.5 for purposes of clarity and to more closely track the language
of the health care conscience protection laws. Recipients are expected to
comply with the records retention and access requirements in 45 CFR 74.53,
45 CFR92.42, 45 CFR 96.30, and any other applicable requirements.
Section 88.6
Complaint Handling and Investigating
Proposed Rule: This section did not appear in the proposed rule.
Final Rule: We have included a new section 88.6 to clarify, as was
stated in the preamble to the proposed rule, that the HHS Office for Civil
Rights (OCR) has been designated to receive complaints of discrimination and
coercion based on the health care conscience protection statutes and this
regulation. OCR will coordinate handling of complaints with the staff of the
Departmental programs from which the entity, with respect to which a
complaint has been filed, receives funding (i.e., Department funding
component).
V. Analysis of Economic
Impacts
Executive
Order 12866-Regulatory Planning and Review
HHS has examined the economic implications of this final rule as required by
Executive Order 12866. Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety, and
other advantages; distributive impacts; and equity). Executive Order 12866
classifies a rule as significant if it meets any one of a number of
specified conditions, including: having an annual effect on the economy of
$100 million, adversely affecting a sector of the economy in a material way,
adversely affecting competition, or adversely affecting jobs. A regulation
is also considered a significant regulatory action if it raises novel legal
or policy issues. HHS has determined that, although this final rule is not
economically significant, it is a significant regulatory action as defined
by Executive Order 12866.
[Inadequate Cost/Benefit Analysis]
Comment: One Comment stated that HHS did not provide an adequate cost
benefit analysis as required by E.O.12866. The Comment pointed out that the
Department concluded that the rule is a significant regulatory action but
did not undertake a more formal analysis.
Response: HHS disagrees.
Our conclusion, based on the analysis of impacts of the proposed rule,
was that the rule was not economically significant. Therefore, the
assessment of potential costs and benefits provided was sufficient to meet
the requirements of the Executive Order.
Comment: Two Comments stated HHS's analysis was inadequate in
that it did not consider the costs of additional health care or other
impacts on patients and employers because various definitions had been
broadened.
Another Comment stated that HHS did not asses the effects on
public health resulting from a decrease in access to care.
Response: HHS disagrees.
As stated previously, the Department does not agree that the
interpretation of the terms used in this rule have been broadened or that
the scope of the laws were expanded. Nor does HHS agree that this rule would
cause changes in staffing or other processes beyond those changes entities
have already incurred in order to comply with existing statutes.
This final rule does not limit patient access to health care, but rather
implements existing federal laws. Thus, we have not changed our analysis in
Response to this Comment.
An underlying assumption of this regulation is that the health care
industry, including entities receiving Department funds, will benefit from
more diverse and inclusive work forces by informing health care workers of
their rights and fostering an environment in which individuals from many
different faiths and philosophical backgrounds are encouraged to
participate. As a result, we cannot accurately account for all of the
regulation's future benefits, but the Department is confident that the
future benefits will exceed the costs of complying with the regulation.
Comment: One Comment suggested that the number of affected
entities suggests that the benefits will not exceed the costs of complying
with the regulation. The Commenter provided no clarification and no data to
support this statement.
Response: The Department has not revised
its analysis in Response to this Comment. The statutes mandating the
requirements for protecting health care workers as discussed in this rule
have been in effect for a number of years. Therefore, the regulatory burden
associated with this rule is largely associated with the incremental costs
of certifying to the Federal government and the cost of collecting and
maintaining records of certification statements from sub-recipients. We
entities that would be required to certify to be 571,947 (see Table I).[7]
This estimate has been revised from the proposal to reflect new
exceptions to the certification requirement for recipients of ACF, AOA, and
IHS funds. We do not distinguish between recipients and subrecipients of HHS
funding. Each entity could be a recipient, a sub-recipient, or both.
The Department envisions three subcategories 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.
In the analysis to the proposed rule, we explained that indirect costs
associated with the certification requirement might include costs for such
actions as staffing/scheduling changes and internal reviews to assess
compliance. We further explained that there is insufficient data to estimate
the number of funding recipients not currently compliant with the Church
Amendments, PHS Act § 245, or the Weldon Amendment.
We received no Comments indicating that there were any funding recipients
not currently compliant. Therefore, we continue to assume that, because
together these three federal statutes have been inexistence for many years,
the incremental indirect costs of certification will be minimal for
Department funding recipients.
Comment: Four Commenters argued against our administrative cost
estimates associated with the certification process. These Comments stated
that the analysis of the proposed rule did not sufficiently account for the
cost of collecting, maintaining, and submitting written certifications.
However, the Comments provided no new information or data.
Response:
HHS disagrees. In determining the costs associated with collecting and
maintaining the certification, we reviewed the analysis and regulatory costs
associated with or conducted for several other similar certification
requirements for HHS programs. The Comments did not provide any new
information or data nor did they suggest any activities for which we did not
already account in the analysis. Thus, we have not changed the analysis in
Response to these Comments.
The direct cost of certification is the cost of reviewing the
certification language, reviewing relevant entity policies and procedures,
and reviewing files before signing. We estimate that each of the 571,947
entities will spend an average of 30 minutes on these activities. Although
some entities may need to sign a certification statement more than once, we
assume that the entity will only carefully review the language, procedures
and their files before signing the initial statement each year. We assume
the cost of signing subsequent statements to be small.
Some existing HHS certification forms specify the certification statement
should be signed by the CEO, CFO, direct owner, or Chairman of the Board.
According to Bureau of Labor Statistics wage data, the mean hourly wage for
occupation code 11-1011, Chief Executives, is $72.77. We estimate the loaded
rate to be $145.54. Thus, the cost associated with the act of certification
is $41.6 million (571,947 × .5 × $145.54).The direct cost of collecting and
maintaining certifications made by subrecipients is estimated as the labor
cost. We assume that each of the 63,741 grant awardees and 4,245 contractors
doing business with HHS have at least one sub-recipient. We also assume
that, on average, each grant awardee and contractor will spend one hour
collecting and maintaining certifications made by sub-recipients. The mean
hourly wage for office and administrative support occupations, occupation
code 43-0000, is $15.00, or $30 loaded. Thus the cost of collecting and
maintaining records is estimated to be $2 million (67,986 entities × 1 hour×
$30).
Comment: One Comment suggested the analysis should consider the
legal fees likely to flow from litigation over the proposed regulations.
Response: HHS disagrees. In assessing the costs and benefits of
regulations, the government assumes compliance. Thus, the amount of
litigation is assumed to be minimal and very difficult to predict. The total
quantifiable costs of the regulation are estimated to be $43.6million each
year.
Congressional Review Act
The Congressional Review Act defines a ''major rule'' as ''any rule that the
Administrator of the Office of Information and Regulatory Affairs (OIRA) of
the Office of Management and Budget finds has resulted in or is likely to
result in-(A) an annual effect on the economy of $100,000,000 or more; (B) a
major increase in costs or prices for consumers, individual industries,
federal, State, or local government agencies, or geographic regions; or
(C)significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
enterprises to compete with foreign based enterprises in domestic and export
markets.'' 5 U.S.C. 804(2).
Based on OMB's review of the rule under Executive Order 12866, the
Administrator of OIRA has determined that this rule is not a major rule for
purposes of the Congressional Review Act. This finding of the Administrator
is not subject to judicial review. 5 U.S.C.805.
Regulatory Flexibility Act
HHS has examined the economic implications of this final rule as required by
the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a
significant economic impact on a substantial number of small entities, the
Regulatory Flexibility Act requires agencies to analyze regulatory options
that would lessen the economic effect of the rule on small entities. This
will not impose significant costs on small entities. Therefore, the
Secretary certifies that this rule will not result in a significant impact
on a substantial number of small entities.
Comment: One Comment
suggested HHS should assess the impact on small entities who will incur
costs to hire new staff and make staffing changes to accommodate objections
by workforce members.
Response: HHS acknowledges that there may be indirect costs
associated with the certification requirement including costs for such
actions as staffing/scheduling changes and internal reviews to assess
compliance. As stated in the proposed rule, there continues to be
insufficient data to estimate the number of funding recipients not currently
compliant with the Church Amendments, PHS Act § 245, or the Weldon
Amendment. Because together these three federal statutes have been
inexistence for many years, we expect the incremental and indirect costs of
certification to be minimal for Department funding recipients. HHS received
no Comments on this assumption. Therefore, we continue to conclude that
these indirect costs of certification will be minimal.
Unfunded Mandates Reform
Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4)requires
cost-benefit and other analyses before any rulemaking if the rule would
include a ''Federal mandate that may result in the expenditure by State,
local, and tribal governments, in the aggregate, or by the private sector,
of $100,000,000 or more (adjusted annually for inflation) in any 1 year.''
The current inflation adjusted statutory threshold is about$115 million. HHS
has determined that this final rule would not constitute a significant rule
under the Unfunded Mandates Reform Act.
Federalism
Executive Order 13132 establishes certain requirements that an agency must
meet when it promulgates a final rule that imposes substantial direct
requirement costs on state and local governments, preempts State law, or
otherwise has federalism implications.
All three statutes implemented
through this regulation-the Church Amendments, PHS Act § 245, and the Weldon
Amendment-impose restrictions on States, local governments, and public
entities receiving funds from the Department, including under certain
Department implemented statutes. Insofar as these regulations impact State
and local governments in addition to those impacts caused by the
statutoryprovisions, they do so only to the extent that States and local
governments are required to submit certifications of compliance with the
statutes and this regulation, as applicable.
Since we expect the recipients of Department funds to comply with
existing federal law, we anticipate the impact on States and local
governments of the certification requirement to be negligible. The
Department received Comments from a number of States, State officials, or
components of State governments on the proposed rule. The Department
considered those Comments in finalizing the rule.
Assessment of Federal Regulation and Policies on Families
Section 654 of the Treasury and General Government Appropriations Act of
1999 requires federal departments and agencies to determine whether a
proposed policy or regulation could affect family well-being. If the
determination is affirmative, then the Department or agency must prepare an
impact assessment to address criteria specified in the law.
Comment:
Several Comments disagreed with the Department's assertion in the
proposed rule that the regulation will not have an impact on family
well-being. Another Commenter stated that the Treasury and General
Government Appropriations Act of 1999 requires the Department to determine
if the proposed rule would affect family well-being. The Commenter stated
that if family well-being is affected, the Department must provide an impact
assessment of these effects. The Commenter also stated that the proposed
rule does not adequately address the impact on family well being.
Response: The Department disagrees.
This final rule defines certain key terms, ensures that recipients of
Department funds know about their legal obligations under existing federal
health care provider conscience protection provisions, and requires written
certification by certain recipients that they will comply with such
provisions, as applicable. As stated above, the rule does not expand the
scope of existing federal health care conscience protection laws, nor does
it create new barriers to health care access that might have an impact on
family well-being. The Department finds that this rule does not affect
family well-being within the meaning of meaning of section 654 of the
Treasury and General Government Appropriations Act, 1999, enacted as part of
the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999
(Pub. L. 105-277, 112 Stat. 2681).
VI. Paperwork Reduction
Act of 1995
HHS received Comments on the burden associated with the written
certification requirements contained in sections 88.5(a), (c) and (d) of
this final rule and are therefore soliciting Comments on the information
collection requirements associated with this rule, consistent with the
Paperwork Reduction Act of 1995.
To obtain or retain federal funding for
various activities, the Department requires the certification of all
recipients and sub-recipients of Department funding. The certification and
associated documents are necessary to ensure that recipients and
subrecipients of federal funds comply with federal anti-discrimination law.
Likely respondents to this certification requirement include all entities
required to certify as estimated in the EO 12866 analysis listed above,
which provides a high estimate of571,947 recipients and sub-recipients. As
outlined above, it will take an estimated 30 minutes for each recipient and
sub-recipient to review the relevant language and provide the relevant
certifications as well as, in the case of recipients, to collect and
maintain certifications by sub-recipients, as applicable.
The Department therefore estimates the annual aggregate burden to collect
the information to be as follows:
- The Department is seeking public Comments on the proposed data
collection associated with this final rule through a 60-day Federal
Register notice. Interested persons are invited to send Comments
regarding this burden estimate or any other aspect of this collection of
information, including any of the following subjects:
- (1) The necessity and utility of the proposed information
collection for the proper performance of the agency's functions;
- (2) the accuracy of the estimated burden;
- (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and
- (4) the use of automated collection techniques or other forms of
information technology to minimize the information collection
burden. This final rule becomes effective 30 days after publication.
However, affected parties do not have to comply with the information
collection requirements in the final rule until the Department of
Health and Human Services publishes in the Federal Register the
control numbers assigned by the Office of Management and Budget
(OMB). Publication of the control numbers notifies the public that
OMB has approved these information collection requirements under the
Paperwork Reduction Act of 1995.