[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Rules and Regulations]
[Pages 7714-7791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03461]
[[Page 7713]]
Vol. 84
Monday,
No. 42
March 4, 2019
Part IV
Department of Health and Human Services
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42 CFR Part 59
Compliance With Statutory Program Integrity Requirements; Final Rule
Federal Register / Vol. 84 , No. 42 / Monday, March 4, 2019 / Rules
and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 59
[HHS-OS-2018-0008]
RIN 0937-ZA00
Compliance With Statutory Program Integrity Requirements
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, HHS. Department of Health and Human Services.
ACTION: Final rule.
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SUMMARY: The Office of Population Affairs (OPA), in the Office of the
Assistant Secretary for Health, issues this final rule to revise the
regulations that govern the Title X family planning program (authorized
by Title X of the Public Health Service Act) to ensure compliance with,
and enhance implementation of, the statutory requirement that none of
the funds appropriated for Title X may be used in programs where
abortion is a method of family planning and related statutory
requirements. Accordingly, OPA amends the Title X regulations to
clarify grantee responsibilities under Title X, to remove the
requirement for nondirective abortion counseling and referral, to
prohibit referral for abortion, and to clarify compliance obligations
with state and local laws. In addition, Title X regulations are amended
to clarify access to family planning services where an employer
exercises a religious or moral objection. Finally, Title X regulations
are amended to require physical and financial separation to ensure
clarity regarding the purpose of Title X and compliance with statutory
program integrity provisions, and to encourage family participation in
family planning decisions, as required by Federal law.
DATES: Effective date: This rule is effective on May 3, 2019.
Compliance date: Compliance with the physical separation
requirements contained in Sec. 59.15, is required March 4, 2020.
Compliance with the financial separation requirements contained in
Sec. 59.15 is required by July 2, 2019. Until that date, the
Department will expect grantees to comply with either Sec. 59.15 or
the ``Separation'' section of the guidance at 65 FR 41281, 41282.
Compliance with Sec. Sec. 59.7 and 59.5(a)(13) is required by July
2, 2019.
Compliance for reporting, assurance, and provision of service in
Sec. Sec. 59.5(a)(12) and (13) as it applies to all required reports,
59.5(a)(14), (b)(1) and (8), 59.13, 59.14, 59.17, and 59.18 is required
by July 2, 2019.
Compliance for all other requirements of this final rule is
required by the effective date, that is, by May 3, 2019.
FOR FURTHER INFORMATION CONTACT: The Office of the Assistant Secretary
for Health (OASH) at (202) 690-7694, [email protected], or by mail at 200
Independence Avenue SW, Washington, DC 20201
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary and Background
A. Executive Summary
1. Purpose
2. Summary of the Major Provisions
a. Clear Financial and Physical Separation
b. Ensure Transparency for Legal and Ethical Use of Taxpayer
Dollars Among Subrecipients
c. Nondirective Pregnancy Counseling Permitted, Not Required
d. Referral for Abortion as a Method of Family Planning
Prohibited, No Longer Required
e. Sexual Abuse Reporting Requirements Training and Protocols
f. Family Participation in Family Planning Decisionmaking
g. Expanded Review and Selection Criteria
h. Formal Revocation of Compliance With Title X Requirements by
Project Recipients in Selecting Subrecipients Rule
3. Summary of Costs, Savings and Benefits of the Major
Provisions
B. Background
II. Statutory Authority, Overview, Analysis, and Response to Public
Comments
A. General Comments
B. To what programs do these regulations apply? (42 CFR 59.1)
C. Definitions (42 CFR 59.2)
1. Definition of Advanced Practice Provider
2. Definition of Family Planning
3. Definition of Grantee
4. Definition of Low Income Family
5. Definition of Program or Project
6. Definition of Subrecipient
D. Who is eligible to apply for a family planning services grant
or contract? (42 CFR 59.3)
E. What requirements must be met by a family planning project?
(42 CFR 59.5)
1. Broad Range of Acceptable and Effective Family Planning
Methods (42 CFR 59.5(a)(1))
a. Acceptable and Effective Methods and Services
b. Projects Required To Provide a Broad Range of Family Planning
Methods and Services, But Participating Entities May Offer a Limited
Number of Family Planning Methods and Services
c. Listing Particular Services in the Broad Range of Family
Planning Services That May Be Provided
2. Projects Shall Not Provide, Promote, Refer For, or Support
Abortion as a Method of Family Planning (42 CFR 59.5(a)(5))
3. Removal of the Requirement for Consultation (42 CFR
59.5(a)(10))
4. Promotion of Access to Comprehensive Primary Health Services
(42 CFR 59.5(a)(12))
5. Title X Transparency (42 CFR 59.5(a)(13)
6. Encouragement of Family Participation (42 CFR 59.5(a)(14))
7. Provide for Medically Necessary Services (42 CFR 59.5(b)(1))
8. Provide for Coordination and Referral, Consistent With
Prohibition on Referral for Abortion (42 CFR 59.5(b)(1))
F. Criteria for Selection of Grantees (42 CFR 59.7)
G. Confidentiality (42 CFR 59.11)
H. Standards of Compliance With Prohibition on Abortion (42 CFR
59.13)
I. Requirements and Limitations With Respect to Post-Conception
Activities (42 CFR 59.14)
1. Prohibition on Referral For, and Encouragement, Promotion,
Advocacy, Support, and Assistance of, Abortion as a Method of Family
Planning (42 CFR 59.14(a), 59.5(a)(5), and 59.16(a))
2. Information About Prenatal Care, Use of Permitted Information
To Refer for Abortion, and Examples (42 CFR 59.14(b)(1), (c), and
(e))
3. Emergency Care and Medically Necessary Information (42 CFR
59.14(b)(2) and 59.14(d))
J. Maintenance of Physical and Financial Separation (42 CFR
59.15)
K. Prohibition on Activities That Encourage, Promote or Advocate
for Abortion (42 CFR 59.16)
L. Compliance With Reporting Requirements (42 CFR 59.17)
M. Appropriate Use of Funds (42 CFR 59.18)
N. Transition Provisions (42 CFR 59.19)
III. Economic/Regulatory Impact and Paperwork Burden
A. Introduction and Summary
1. Executive Orders 12866 and 13563 and the Congressional Review
Act
2. Regulatory Flexibility Act (RFA)
3. Unfunded Mandates Reform Act
4. Federalism
5. Summary of the Final Rule
B. Analysis of Economic Impacts
1. Need for Regulatory Action
2. Affected Entities
3. Estimated Costs
a. Learning the Rule's Requirements
b. Training
c. Assurance Submissions
d. Documentation of Compliance
e. Monitoring and Enforcement
f. Physical Separation
g. Encouraging Parental Involvement in Family Planning Services
4. Estimated Benefits
a. Upholding and Preserving the Purpose and Goals of the Title X
Program
b. Patient/Provider Benefits and Protections
C. Analysis of Regulatory Alternatives
D. Executive Order 13771
E. Regulatory Flexibility Analysis
F. Assessment of Federal Regulation and Policies on Families
G. Paperwork Reduction Act
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I. Executive Summary and Background
A. Executive Summary
1. Purpose
The primary purpose of this rule is to finalize, with changes in
response to public comments, revisions to the Title X family planning
regulations proposed on June 1, 2018.\1\ This rule, promulgated
pursuant to the Department's authority,\2\ will ensure compliance with,
and enhance implementation of, the statutory requirement that none of
the funds appropriated for Title X may be used in programs where
abortion is a method of family planning, as well as related statutory
requirements. In addition, the rule ensures that grantee
responsibilities, referral requirements, and documentation obligations
are clear under the Title X program. The rule also clarifies that
provision of family planning services under Title X may be available
under the good reason exception at the discretion of the project
director for women denied coverage for contraceptives if the sponsor of
their health plan exercises a religious or moral exemption recognized
by the Department.\3\ The rule protects vulnerable populations by
ensuring Title X providers comply with State reporting requirements.
And, consistent with Federal law, the rule encourages family
participation in family planning decisions of minors except where the
minor is or may be the victim of child abuse or incest. To ensure the
best applicants are chosen, the rule expands review and selection
criteria to include provisions that will help evaluate applicants'
adherence to statutory requirements and goals. In addition, the rule
formally repeals the 2016 amendments to the Title X eligibility
requirements, which were nullified by a joint resolution of
disapproval, under the Congressional Review Act, signed by the
President. This rule will protect the integrity of the Title X program,
pursuant to congressional purpose, to offer a broad range of family
planning methods and services and improve the quality of programs that
specifically provide support in this area.
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\1\ See Compliance with Statutory Program Integrity
Requirements, 83 FR 25502 (proposed June 1, 2018) (to be codified at
42 CFR part 59).
\2\ For a detailed discussion regarding statutory authority, see
infra Section II. Statutory Authority, Overview, Analysis, and
Response to Public Comments.
\3\ See Religious exemptions in connection with coverage of
certain preventive services, 45 CFR 147.132 (2019); see also Moral
exemptions in connection with coverage of certain preventive health
services, 45 CFR 147.133 (2019).
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2. Summary of the Major Provisions
a. Clear Financial and Physical Separation
This rule finalizes requirements that ensure clear physical and
financial separation between a Title X program and any activities that
fall outside the program's scope. This physical and financial
separation will ensure compliance with the statutory requirement that
Title X funding not support programs where abortion is a method of
family planning--and is consistent with the plain text of Section 1008,
legislative history, and case law. In particular, the rule protects
against the intentional or unintentional co-mingling of Title X
resources with non-Title X resources or programs by amending the
Department's regulation finalized on July 3, 2000, (the ``2000
regulations''), which required no physical separation and only limited
financial separation.\4\ This rule will require Title X providers to
maintain physical and financial separation from locations which provide
abortion as a method of family planning.
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\4\ See Standards of Compliance for Abortion-Related Services in
Family Planning Services Projects, 42 CFR part 59, which omit any
mention of physical or financial separation; see also Standards of
Compliance for Abortion-Related Services in Family Planning Services
Projects, 65 FR 41270, 41275-41276 (July 3, 2000) where the
Department discusses its decision in the 2000 regulation to require
financial separation, while choosing to not require physical
separation.
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Together, these changes address several concerns of the Department.
They address concerns over the fungibility of Title X resources and the
potential use of Title X resources to support programs where, among
other things, abortion is a method of family planning. They address the
potential for ambiguity between approved Title X activities and non-
Title X activities and services, which creates significant risk for
public confusion over the scope of Title X services, including whether
Title X funds are allocated for, or spent on, non-Title X services,
including abortion-related purposes. And they address the concern that
Title X resources could facilitate the development of, and ongoing use
of, infrastructure for non-Title X activities. The Department seeks to
protect Title X (and Title X funds) as the only discrete, domestic,
Federal grant program focused solely on the provision of cost-effective
family planning methods and services. The final rule thus requires
physical and financial separation to protect the statutory integrity of
the Title X program, to eliminate the risk of co-mingling or misuse of
Title X funds, and to prevent the dilution of Title X resources.
b. Ensure Transparency for Legal and Ethical Use of Taxpayer Dollars
Among Subrecipients
This rule facilitates the legal and ethical use of taxpayer dollars
by implementing reporting requirements with respect to the use of Title
X funds. The 2000 regulations do not require grantees to submit
significant information to the government about their subrecipients,
referral agencies, or other partners to whom Title X funds may flow.
This lack of reporting can be a significant barrier to the Department's
ability to ensure Title X funds are directed only to Title X
activities. Accordingly, the final rule requires that Title X grant
applicants include, as part of their applications, a list of all
planned subrecipients, detailed descriptions of the extent of services
and collaboration with subrecipients, and a clear explanation of how
the applicant, if successful, would conduct an oversight program with
respect to its subrecipients.\5\ The final rule defines a subrecipient
as any entity that provides family planning services with Title X funds
under a written agreement with a grantee or another subrecipient.
Consistent with grant reporting requirements, grantees must regularly
report and demonstrate their own compliance, as well as ensure the
compliance of their subrecipients with all statutory and regulatory
requirements. The Department will also require grantees to establish a
plan to ensure that they and their subrecipients comply with all
applicable State reporting requirements of child abuse, child
molestation, sexual abuse, rape, incest, intimate partner violence, and
human trafficking, adequately train staff regarding such requirement
and include protocols that ensure such minors are provided counseling
on how to resist attempts to coerce them into engaging in sexual
activities; and will commit to preliminary screening of such minors.
The final rule establishes that the continuation of funding for
grantees and subrecipients is contingent on their demonstration to the
satisfaction of the Secretary that the statutory and regulatory
requirements of Title X have been met. To ensure proper accounting of
Title X funds, the Secretary may
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review grantee and subrecipient records to ensure regulatory
compliance.
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\5\ To further ensure program transparency (and ensure a
seamless continuum of care), applicants and grantees are also
required to provide certain information about agencies or
individuals providing referral services and their collaborations
with such referral agencies and individuals.
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To increase program integrity, the Department will also increase
various monitoring and reporting requirements. Under the final rule,
grantees will be required to receive approval for any change in the use
of grant funds, and to fully account for and justify charges against
the Title X grant. The final rule will also increase monitoring
requirements to better ensure appropriate billing practices. And
because the 2000 regulations offer scant guidance on the Anti-lobbying
Act and appropriations law provisions applicable to Title X, this final
rule will require Title X grantees to provide assurances satisfactory
to the Secretary that they both understand and agree to the prohibition
against lobbying and political activity in the Title X project.
The Department believes that these changes will ensure that OPA has
the information necessary to determine whether Title X projects,
grantees, and subrecipients are compliant with the statutory and
regulatory provisions applicable to the program.
c. Nondirective Pregnancy Counseling Permitted, Not Required
This rule finalizes several regulatory provisions designed to
ensure that the requirements of the Title X regulations are consistent
with certain laws that protect the conscience rights of individuals and
entities who decline to perform, participate in, or refer for,
abortions. The 2000 regulations require Title X projects to provide
abortion referral \6\ and nondirective counseling on abortion, if
requested. The Department believes this requirement is inconsistent
with federal conscience laws and, as discussed below with respect to
the referral provision, also violates Section 1008. With respect to
conscience, the regulatory requirement to counsel on abortion, if
requested, conflict with HHS enforced statutes protecting conscience in
health care, including the Church Amendment,\7\ Coats-Snowe Amendment
\8\ and the Weldon Amendment \9\ for individual and institutional
entities who object. The Department acknowledged this conflict in the
2008 conscience regulations, stating that its ``current regulatory
requirement that grantees must provide counseling and referrals for
abortion upon request . . . is inconsistent with the health care
provider conscience protection statutory provisions and this
regulation.'' 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 78072, 78087 (Dec. 19, 2008). The
proposed rule in this rulemaking similarly recognized the ongoing
conflict between the 2000 regulation and conscience protections. In the
2008 provider conscience regulation, the Department stated that OPA was
``aware of this conflict with the statutory requirements [of the
Church, Coats-Snowe, and Weldon Amendments] and, as such, would not
enforce this Title X regulatory requirement on objecting grantees or
applicants,'' id., but was unable to directly address the Title X
requirements, given the rulemaking context. The Department believes
that it is appropriate and necessary to revise the Title X regulatory
text to eliminate the provisions which are inconsistent with the health
care conscience statutory provisions.\10\
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\6\ Referral for abortion is discussed in the next section.
\7\ The Church Amendments, among other things, prohibit certain
HHS grantees from discriminating in the employment of, or the
extension of staff privileges to, any health care professional
because they refused, because of their religious beliefs or moral
convictions, to perform or assist in the performance of any lawful
sterilization or abortion procedures. The Church Amendments also
prohibit individuals from being required to perform or assist in the
performance of any health service program or research activity
funded in whole or in part under a program administered by the
Secretary contrary to their religious beliefs or moral convictions.
See 42 U.S.C. 300a-7.
\8\ The Coats-Snowe Amendment bars the federal government and
any State or local government that receives federal financial
assistance from discriminating against a health care entity, as that
term is defined in the Amendment, who refuses, among other things,
to provide referrals for induced abortions. See 42 U.S.C. 238n(a).
\9\ The Weldon Amendment was added to the annual 2005 health
spending bill and has been included in subsequent appropriations
bills. See Consolidated Appropriations Act, 2018, Public Law 115-
141, Div. H, sec. 507(d), 132 Stat. 348, 764; Consolidated
Appropriations Act, 2017, Public Law 115-31, Div. 507(d), 131 Stat.
135, 562. The Weldon Amendment bars the use of appropriated funds on
a federal agency or programs, 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, among other things, refer for
abortions.
\10\ In the preamble to the 2000 regulations, the Department
addressed a comment that the requirement to provide options
counseling ``should not apply to employees of a grantee who object
to providing such counseling on moral or religious grounds,'' and
rejected it, contending that it is not necessary because, under the
Church Amendments, ``grantees may not require individual employees
who have such objections to provide such counseling,'' but ``in such
cases the grantees must make other arrangements to ensure that the
service is available to Title X clients who desire it.'' 65 FR
41270, 41274 (July 3, 2000). But the evidence collected in the
Department's 2018 conscience proposed rule, 83 FR 25502, 25506 (June
1, 2018), suggests that neither grantees nor their employees may
know of the requirements of the Church Amendment. More importantly,
the Department's 2000 analysis failed to consider that the Coats-
Snowe Amendment (and the subsequently passed Weldon Amendment)
protects institutional health care providers from discrimination by
federal programs, including Title X, on the basis of their refusal
to counsel or refer for abortion and, thus, that ``under section 245
of the Public Health Service Act and the Weldon Amendment, the
Department cannot . . . enforce 42 CFR 59.5(a)(5) against an
otherwise eligible grantee or applicant who objects to the
requirement to counsel on or refer for, abortion.'' 73 FR at 78088.
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Under the final rule, the Title X regulations no longer require
pregnancy counseling, but permits the use of Title X funds in programs
that provide pregnancy counseling, so long as it is nondirective.
Nondirective pregnancy counseling is the meaningful presentation of
options where the physician or advanced practice provider (APP) \11\ is
``not suggesting or advising one option over another.'' 138 Cong. Rec.
H2822, H2826, 1992 WL 86830. Section 1008 and its legislative history
offers additional clarity specifically as to abortion, where the
physician or APP cannot engage in ``promoting, encouraging, or
advocating abortion.'' Id. at H2829. Nondirective counseling does not
mean that the counselor is uninvolved in the process or that counseling
and education offer no guidance, but instead that clients take an
active role in processing their experiences and identifying the
direction of the interaction. In nondirective counseling, the Title X
physicians and APPs promote the client's self-awareness and empower the
client to be informed about a range of options, consistent with the
client's expressed need and with the statutory and regulatory
requirements governing the Title X program. In addition, the Title X
provider may provide a list of licensed, qualified, comprehensive
primary health care providers (including providers of prenatal care),
some (but not the majority) of which may provide abortion in addition
to comprehensive primary care.
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\11\ Under this final rule, nondirective counseling may be
provided by physicians and advanced practice providers. As discussed
in detail below, the final rule defines ``advanced practice
providers'' as including physician assistants and advanced practice
registered nurses.
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Accordingly, this final rule eliminates the abortion counseling
requirements in the 2000 regulations, consistent with the Department's
interpretation of federal conscience laws and Section 1008. This rule
continues to allow nondirective pregnancy counseling, as discussed in
more detail below.
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d. Referral for Abortion as a Method of Family Planning Prohibited, No
Longer Required
This rule finalizes the revocation of the requirement that Title X
projects refer for abortion, and finalizes the prohibition against
using Title X funds to refer for abortion as a method of family
planning, or to perform, promote, or support abortion as a method of
family planning. Although the 2000 regulations require Title X programs
to refer for abortion when requested by a client,\12\ the Department no
longer believes that the requirement is appropriate or permissible.
Like the counseling requirement, the Department believes the referral
requirement is in conflict with federal conscience protections, such as
the Church, Coats-Snowe, and Weldon Amendments, for individual and
institutional entities which object, and is finalizing the proposal to
remove that requirement from the regulations. Furthermore, the
Department believes that, in most instances when a referral is provided
for abortion, that referral necessarily treats abortion as a method of
family planning. The Department believes both the referral for abortion
as a method of family planning, and such abortion procedure itself, are
so linked that such a referral makes the Title X project or clinic a
program one where abortion is a method of family planning, contrary to
the prohibition against the use of Title X funds in such programs. The
Department, thus, views such abortion referrals in the Title X project
as a violation of Section 1008, which prohibits the use of Title X
funds in programs where abortion is a method of family planning. See 42
U.S.C. 300a-6. Even if the referral requirement was not in tension with
these statutes, the Department believes that such a requirement may
deter qualified providers from applying for Title X grants or
participating in Title X projects, and may introduce ambiguity about
the use of Title X funds to support abortion as a method of family
planning. Accordingly, this final rule removes the requirement that
Title X funded entities refer for abortion, and prohibits Title X
projects from referring for abortion as a method of family planning, or
from performing, promoting, referring for, or supporting abortion as a
method of family planning.
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\12\ See 42 CFR 59.5; 65 FR 41270, 41278 (July 3, 2000).
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e. Sexual Abuse Reporting Requirements Training and Protocols
This rule finalizes the requirement that Title X programs and
providers comply with State and local sexual abuse reporting
requirements, as well as the requirement for training and clinic
protocols on such requirements and related issues, to ensure that Title
X providers meet the applicable statutory and regulation reporting
requirements of the Title X program and treat the survivors of sexual
abuse and assault with dignity and compassion, without hindering State
and local efforts to prevent sexual abuse.\13\ Section 59.11 of the
2000 regulations, on the confidentiality of Title X records, provides
that personal information may not be disclosed absent consent by the
individual, except to provide treatment, or as required by law, ``with
appropriate safeguards for confidentiality.'' See 42 CFR 59.11. To
ensure that Title X grantees and subrecipients comply with applicable
reporting requirements, the Department clarifies in this final rule
that concerns about confidentiality of information may not be used as a
rationale for noncompliance with such reporting laws.
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\13\ See Department of Defense and Labor, Health and Human
Services, and Education Appropriations Act, 2019 and Continuing
Appropriations Act, 2019, Public Law 115-245, Div. B, sec. 208, 132
Stat. 2981, 3070 (``HHS Appropriations Act 2019'') (emphasizing the
Congressional expectation that ``Notwithstanding any other provision
of law, no provider of services under title X of the PHS Act shall
be exempt from any State law requiring notification or the reporting
of child abuse, child molestation, sexual abuse, rape, or
incest.'').
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As established in Sec. 59.17 of this final rule, Title X providers
are required to comply with all State and local laws regarding
notification or reporting of child abuse, child molestation, sexual
abuse, rape, incest, intimate partner violence, or human trafficking.
The 2000 regulations permit the use of confidential information
obtained by project staff to comply with State and local reporting
requirements,\14\ but do not expressly address the appropriations law
requirement to report certain crimes, nor impose a federal obligation
on Title X grantees and subrecipients to comply with State reporting or
notification requirements. The final rule clarifies that Title X
grantees and subrecipients must comply with State and local laws
requiring notification or reporting of child abuse, child molestation,
sexual abuse, rape, incest, intimate partner violence, and/or human
trafficking. To ensure compliance with that obligation and to ensure
the appropriate care for such patients, their safety, and their
personal empowerment, the final rule requires Title X grantees and
subrecipients to have in place a plan to implement the specific
reporting requirements that apply to them in their State (or
jurisdiction), as well as to provide for annual training for all
personnel with respect to these requirements, how such reports are to
be made, and appropriate interventions, strategies, and referrals.
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\14\ See 42 CFR 59.11.
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As part of prevention, protection, and risk assessment efforts,
grantees and subrecipients are required to include in such plans,
protocols to identify individuals who are victims of sexual abuse or
targets for underage sexual victimization and to ensure that every
minor who presents for treatment is provided counseling on how to
resist attempts to coerce minors into engaging in sexual
activities.\15\ Title X projects are also required, under this final
rule, to conduct a preliminary screening of any minor who presents with
an STD, pregnancy, or suspicion of abuse, in order to rule out
victimization of the minor. Section 59.17 requires grantees and
subrecipients to maintain records that would identify, among other
things, the age of any minor clients served, the age of their sexual
partner(s) where required by State law, and what reports or
notifications were made to appropriate State agencies. The Department
will use this documentation to ensure appropriate compliance with State
notification laws.
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\15\ The annual appropriations laws also impose on Title X
recipients the obligation to provide ``counseling to minors on how
to resist attempt to coerce minors into engaging in sexual
activities.'' See HHS Appropriations Act 2019, Public Law 115-245,
Div. B, sec. 207, 132 Stat. 2981, 3070; Consolidated Appropriations
Act, 2018, Public Law 115-141, Div. H, sec. 207, 132 Stat. 348, 736;
Consolidated Appropriations Act, 2017, Public Law 115-31, Div. H,
sec. 207, 131 Stat. 135, 538; Consolidated Appropriations Act, 2016,
Public Law 114-113, Div. H, sec. 207, 129 Stat 2242, 2620. Such
requirement is also consistent with Title X's direction to provide
special services for adolescents.
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f. Family Participation in Family Planning Decisionmaking
This rule finalizes requirements that Title X providers encourage
appropriate family participation in family planning decisions, as
required by Federal law.\16\ The Title X statute itself requires the
encouragement of such family
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participation to the extent practical,\17\ and the Department will
continue to enforce compliance with this provision. An appropriations
rider specifically emphasizes that grantees encourage family
participation ``in the decision of minors to seek family planning
services.'' \18\ Accordingly, to ensure compliance with these
requirements and the policy underlying them, the Department will also
require specific recordkeeping with respect to such encouragement for
minors. To ensure compliance with the requirement that Title X projects
encourage family participation in the decision of minors to seek family
planning services, Sec. 59.5(a)(14) requires Title X projects to
document in each minor's medical records the specific actions taken to
encourage such family participation or the specific reason why such
family participation was not encouraged. Consistent with the revision
to the unemancipated minor example in the definition of ``low income
family'' that the Department finalizes in this rule, documentation of
such encouragement is not required if the Title X provider documents in
the medical record that (1) the minor is suspected to be the victim of
child abuse or incest and (2) it has, if permitted or required by
applicable State or local law, reported the situation to the relevant
authorities. These requirements are sensitive to confidentiality issues
as well as reporting requirements for abuse.
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\16\ Title X requires that, ``[t]o the extent practical,
entities which receive grants or contracts under this subsection
shall encourage familiy [sic] participation in projects under this
subsection.'' 42 U.S.C. 300(a). Congress also includes a rider in
HHS's annual appropriations act that provides that ``[n]one of the
funds appropriated in this Act may be made available to any entity
under title X of the PHS Act unless the applicant for the award
certifies to the Secretary that it encourages family participation
in the decision of minors to seek family planning services.'' HHS
Appropriations Act 2019, Public Law 115-245, Div. B, sec. 207, 132
Stat. 2981, 3070; Consolidated Appropriations Act 2018, Public Law
115-141, Div. H, sec. 207, 132 Stat. 348, 736.
\17\ The Department notes that, although section 1001 of the PHS
Act states that ``[t]o the extent practicable, entities which
receive grants or contracts under this subsection shall encourage
family participation in projects assisted under this subsection,''
PHS Act Sec. 1001(a), in the U.S. Code, 42 U.S.C. 300(a), the word
``practical'' is used in the provision. The Department believes that
the two words are intended to have the same meaning and uses the two
words interchangeably when discussing the statutory requirement.
\18\ See HHS Appropriations Act 2019, Public Law 115-245, Div.
B, sec. 207, 132 Stat. 2981, 3070.
---------------------------------------------------------------------------
g. Expanded Review and Selection Criteria
This rule updates and expands the review and scoring criteria
applicable to grant applications, to ensure the criteria serve as a
meaningful instrument to assess the quality of the applicant and the
application. The 2000 Title X regulations set forth application review
criteria that give the Department significant flexibility in
determining awards but lack rigor, making it possible for less
qualified applicants to garner high scores and affording the Department
little help in selecting strong Title X grantees. The amended and
revised Sec. 59.7 ensures that successful applicants both meet the
statutory requirements of the Title X program and are adequately
responsive to the statutory goals and purposes of the Title X program.
Under this rule, any grant application that does not clearly address
how the proposal will satisfy the requirements of the rule would not
proceed to the competitive review process, but would be deemed
ineligible for funding.
The Department will explicitly summarize each requirement of the
Title X regulations (or include the entire regulation) within the
Funding Announcement and will require applicants to describe how they
affirmatively comply, or would affirmatively comply with each
provision. Once an applicant successfully demonstrates such affirmative
compliance with the Title X regulations (a yes/no issue), the
Department will consider each applicant competitively according to the
criteria set forth in the regulation. The first criterion ensures that
the project offers a broad range of acceptable and effective family
planning methods and services and does not use abortion as a method of
family planning. The second criterion looks at the relative need of the
applicant and whether the applicant will make rapid and effective use
of the funds. The third criterion takes into account the number of
patients being served, while also considering the availability of
family planning services in the proposed area. The fourth criterion
considers the extent to which the services are needed in that local
area and if the applicant proposes innovative ways to provide services
to unserved or underserved patients. These provisions better achieve
the statutory requirements and goals of Title X and increase
competition and rigor among applicants, encouraging broader and more
diverse applicants and better ensuring the selection of quality
applicants.
h. Formal Revocation of Compliance with Title X Requirements by Project
Recipients in Selecting Subrecipients
This rule formally revokes the 2016 amendments to the Title X
eligibility requirements. In 2016, the Department finalized a rule that
amended Title X eligibility requirements, prohibiting any grantee/
recipient making service subawards as part of its Title X project, from
excluding an entity from receiving a subaward for reasons other than
its ability to provide Title X services. Compliance With Title X
Requirements by Project Recipients in Selecting Subrecipients, 81 FR
91852, 91859-91860 (Dec. 19, 2016) (adding paragraph (b) to 45 CFR
59.3) (the ``2016 regulation''). The Department's stated reason for
issuing the rule was to respond to new approaches to competing or
distributing Title X funds that were being employed by several States.
Id. at 91858-91859. The 2016 regulation took effect on January 18,
2017, but was nullified under the Congressional Review Act on April 13,
2017, when the President signed House Joint Resolution 43. See Public
Law 115-23, 131 Stat. 89. Consistent with the joint resolution of
disapproval, this rule repeals the 2016 regulation and, thus, permits
States and other Title X grantees freely to select Title X
subrecipients so long as they comply with the statutory, regulatory,
and policy provisions in the funding announcement.
3. Summary of Costs, Savings and Benefits of the Major Provisions
------------------------------------------------------------------------
Savings and
Provision benefits Costs
------------------------------------------------------------------------
Clear Financial and Physical The purpose of The Department
Separation. this provision is estimates that
to ensure that there will be
the regulatory transition costs
language is where certain
consistent with other programs
Section 1008 of that shared
the Public Health facilities with
Service Act. The Title X programs
Department must now
estimates no establish
specific economic separate physical
savings from facilities. After
finalizing this receiving public
part of the rule. comments, the
However, the Department
Department estimates
expects the physical
quality of Title compliance costs
X services to to be $36.08
improve as Title million.
X funds are
focused and
prioritized
according to the
statutory
parameters.
[[Page 7719]]
Ensure Transparency for Legal The purpose of The Department
and Ethical Use of Taxpayer this provision is estimates, in
Dollars among Subrecipients. to ensure that part based on
Title X funds are public comments,
allocated and that the cost of
accounted for implementing
both by Title X additional
grantees and by reporting and
the Department. training
The Department requirements will
estimates no be $8.53 million.
specific cost Medical and health
savings from services managers
finalizing this will spend an
part of the Rule. average of four
However, the hours each year
Department to complete
expects that reports regarding
enhanced information
accounting and related to
monitoring will subrecipients,
result in more and referral
effective use of agencies and
Title X resources. individuals
involved in the
grantee's Title X
project at each
grantee and
subrecipient. The
labor cost will
be $254,000 each
year ($52.58 per
hour x 4 hours x
1,208 grantees
and
subrecipients).
Nondirective Pregnancy The purpose of The Department
Counseling Permitted, Not this provision is estimates no
Required. to remove the costs from
requirement that finalizing this
providers provide part of the rule.
pregnancy
counseling,
particularly,
abortion
counseling.
Eliminating the
requirement to
counsel for
abortion, and
allowing non-
directive
pregnancy
counseling in
general, will
relieve burdens
by giving
projects
flexibility, and
relieve burdens
on conscience
that some
entities and
individuals
experienced from
complying with
the previous
requirement, or
provide more
flexibility for
applicants that
otherwise might
not have applied
due to the
burdens on
conscience of the
previous
requirement.
This rule will
also reduce the
regulatory burden
associated with
monitoring and
Title X providers
for compliance
with the abortion
counseling
requirement.
Abortion Referral Prohibited, No The purpose of The Department
Longer Required. this provision is estimates no
to remove the costs associated
requirement for, with removing the
and institute a requirement for
prohibition abortion
against abortion referral. The
referral in the addition of a
Title X program. prohibition
Eliminating the against abortion
requirement to referral will
refer for involve no
abortion will additional
relieve burdens monitoring costs,
on conscience as current
that some mechanisms in
entities and place are
individuals expected to be
experienced from sufficient.
complying with
the previous
requirement, and
provide more
flexibility for
applicants that
otherwise might
not have applied
due to the
burdens on
conscience of the
previous
requirement. This
rule will also
reduce the
regulatory burden
associated with
monitoring and
regulating Title
X providers for
compliance with
the abortion
referral
requirement.
Sexual Abuse Reporting The purpose of The Department
Requirements Training and this provision is estimates that
Protocols. to ensure individuals
providers are involved with
complying with delivering family
State and local planning services
sexual abuse would require an
reporting average of 4
requirements. The hours of training
Department in the first year
estimates no following
specific economic publication of
savings from this rule. In
finalizing this subsequent years,
part of the rule. the Department
However, the assumes that this
Department new information
expects Title X would be
providers will be incorporated into
more informed existing training
about State and requirements,
local reporting resulting in no
requirements, and incremental
therefore, will burden. As a
protect result, using
vulnerable wage information
populations. provided in Table
2, this would
imply costs of
$2.71 million in
the first year
following
publication of a
final rule in
this rulemaking.
Family Participation in Family The purpose of The Department
Planning Decisionmaking. this provision is estimates that
to ensure complying with
compliance with the requirement
the requirement to encourage
by Congress to family
encourage family participation
participation in will result in
family planning 75% (600,000) of
decisionmaking, adolescent
and to include patients' medical
this requirement records requiring
in regulation. appropriate
The Department documentation. As
estimates no a result, using
specific economic wage information
savings from provided, this
finalizing this would imply costs
part of the rule. of $2.0 million
However, the in the each year
Department following
expects Title X publication of a
providers will final rule in
encourage parent this rulemaking.
and child
communication as
is expected under
Federal law.
[[Page 7720]]
Expanded Review and Selection The purpose of ..................
Criteria. this provision is
to increase the
quality and
expand the
specificity of
grant application
review criteria.
The Department
estimates no
specific economic
savings from
finalizing this
part of the rule.
However, these
criteria will
better achieve
the statutory
requirements and
goals of Title X
by increasing
competition and
rigor among
applicants,
encouraging
broader and more
diverse
applicants and
better ensuring
the selection of
quality
applicants.
Formal Revocation of Compliance The purpose of The Department
with Title X Requirements by this provision is estimates no
Project Recipients in Selecting to finalize the costs from
Subrecipients Rule. revocation of the finalizing this
2016 regulation. part of the rule
The Department as it is a formal
estimates no repeal of a
specific economic change that was
savings from nullified by
finalizing this joint resolution
part of the rule of disapproval
as it is a formal under the
repeal of a Congressional
change that was Review Act that
nullified by was signed by the
under the President.
Congressional
Review Act.
------------------------------------------------------------------------
B. Background
Title X of the Public Health Service Act, 42 U.S.C. 300 through
300a-6, was enacted in 1970 by Public Law 91-572, 84 Stat. 1504. As
amended, it authorizes the Secretary of Health and Human Services,
among other things, ``to make grants to and enter into contracts with
public or nonprofit private entities to assist in the establishment and
operation of voluntary family planning projects which shall offer a
broad range of acceptable and effective family planning methods and
services (including natural family planning methods, infertility
services, and services for adolescents).'' 42 U.S.C. 300(a).
Presently, the Title X program funds approximately 90 public health
departments and community health, family planning, and other private
nonprofit agencies through grants, supporting delivery of family
planning services at almost 4,000 service sites.\19\ As a program
designed to provide voluntary family planning services, the Title X
program should help men, women, and adolescents make healthy and fully
informed decisions about starting a family and determining the number
and spacing of children.
---------------------------------------------------------------------------
\19\ Fowler et al., Family Planning Annual Report: 2017 National
Summary (Aug. 2018), https://www.hhs.gov/opa/sites/default/files/title-x-fpar-2017-national-summary.pdf.
---------------------------------------------------------------------------
Section 1008 of the Act contains the following prohibition, which
has not been altered since it was enacted in 1970: ``None of the funds
appropriated under this title shall be used in programs where abortion
is a method of family planning.'' 42 U.S.C. 300a-6. The Conference
Report described the purpose of this provision as follows:
It is, and has been, the intent of both Houses that funds
authorized under this legislation be used only to support preventive
family planning services, population research, infertility services,
and other related medical, information, and educational activities.
The conferees have adopted the language contained in section 1008,
which prohibits the use of such funds for abortion, in order to make
clear this intent.
H.R. Rep. No 91-1667, at 8-9 (1970) (Conf. Rep.). Later Congresses
have, through annual appropriations provisions, reiterated aspects of
this requirement, for example, by adding that ``amounts provided to
said [voluntary family planning] projects under such title shall not be
expended for abortions.'' See, e.g., HHS Appropriations Act 2019,
Public Law 115-245, Div. B, 132 Stat. at 3070.
Since it originally created the Title X program in 1970, Congress
has, from time to time, imposed additional requirements on it,
including the following:
Requirement that ``all pregnancy counseling shall be
nondirective.'' \20\
---------------------------------------------------------------------------
\20\ See Omnibus Consolidated Rescissions and Appropriations Act
of 1996, Public Law 104-134, sec. 104, 110 Stat. 1321 (1996)
(``Omnibus Appropriations Act 1996''); HHS Appropriations Act 2019,
Public Law 115-245, Div. B, 132 Stat. at 3070-71.
---------------------------------------------------------------------------
Obligation to ensure that Title X funds ``shall not be
expended for any activity (including the publication or distribution of
literature) that in any way tends to promote public support or
opposition to any legislative proposal or candidate for public
office.'' \21\
---------------------------------------------------------------------------
\21\ HHS Appropriations Act 2019, Public Law 115-245, Div. B,
132 Stat. at 3071.
---------------------------------------------------------------------------
Requirement that Title X (1) projects provide distinct
services for adolescents; \22\ (2) service providers encourage family
participation in family planning services including, but not limited
to, those for minors; \23\ (3) grantees certify to the Secretary that
they ``provide counseling to minors on how to resist attempts to coerce
minors into engaging in sexual activities.'' \24\
---------------------------------------------------------------------------
\22\ See 42 U.S.C. 300(a) (requirement to provide ``a broad
range of acceptable and effective family planning methods and
services (including . . . services for adolescents)'').
\23\ See Omnibus Budget Reconciliation Act of 1981, Public Law
97-35, sec. 931(b)(1), 95 Stat. 357, 570 (1981) (amending Section
1001(a) of the Public Health Service Act to require that ``[t]o the
extent practical, entities which receive grants or contracts . . .
shall encourage family participation in projects assisted under this
subsection.''); 42 234 U.S.C. 300(a); Departments of Labor, Health
and Human Services, and Education, and Related Agencies
Appropriations Act, 1998, Public Law 105-78, sec. 212, 111 Stat.
1467, 1495 (``HHS Appropriations Act 1998''); HHS Appropriations Act
2019, Public Law 115-245, Div. B, sec. 207, 132 Stat. at 3090.
\24\ Departments of Labor, Health and Human Services, and
Education, and Related Agencies Appropriations Act, 1998, Public Law
105-78, sec. 212, 111 Stat. 1467, 1495; HHS Appropriations Act 2019,
Public Law 115-245, Div. B, sec. 207, 132 Stat. at 3090.
---------------------------------------------------------------------------
Condition that, ``[n]otwithstanding any other provision of
law, no provider of services under Title X of the PHS Act shall be
exempt from any State law requiring notification or the reporting of
child abuse, child molestation, sexual abuse, rape, or incest.'' \25\
---------------------------------------------------------------------------
\25\ HHS Appropriations Act 2019, Public Law 115-245, Div. B,
sec. 208, 132 Stat. at 3090.
Title X authorizes the Secretary to promulgate regulations governing
the program. 42 U.S.C. 300a-4. In the preamble to the proposed rule,
the Department explained that, since 1971, it has repeatedly exercised
rulemaking authority with respect to the Title X program. The
Department began issuing regulations implementing Title X, including
section 1008, in 1971. See 36 FR 18465 (Dec. 15, 1971). Although those
regulations, and revised regulations issued in 1980, 45 FR 37436 (Jun.
3, 1980), as well as guidelines promulgated in 1981, prohibited Title X
projects from providing abortion as a method of family planning, they
did not
[[Page 7721]]
provide further guidance on the application of that prohibition.
On February 2, 1988, the Secretary of Health and Human Services
promulgated Title X regulations (the ``1988 regulations'') to give
specific program guidance regarding the statutory prohibition on the
use of Title X funds in programs where abortion is a method of family
planning. See Statutory Prohibition on Use of Appropriated Funds in
Programs Where Abortion is a Method of Family Planning; Standard of
Compliance for Family Planning Services Projects, 53 FR 2922 (Feb. 2,
1988). The 1988 regulations had several key features to support
compliance with the statutory prohibition. To more effectively
implement section 1008, the regulations prohibited Title X projects
from counseling or referring project clients for abortion as a method
of family planning; required grantees to separate their Title X
project--physically and financially--from prohibited abortion-related
activities; and established compliance standards for family planning
projects under Title X to specifically prohibit certain actions that
promote, encourage, or advocate abortion as a method of family
planning, such as the use of project funds for lobbying for abortion,
developing and disseminating materials advocating abortion, or taking
legal action to make abortion available as a method of family planning.
See 53 FR 2945.
The 1988 regulations were upheld on both statutory and
constitutional grounds by the United States Supreme Court in Rust v.
Sullivan, 500 U.S. 173 (1991). In Rust, the Supreme Court rejected
claims that the regulations violated the Administrative Procedure Act
(APA), the First Amendment, the Fifth Amendment, or the Title X
statute. Regarding the APA, the Court applied Chevron U.S.A., Inc. v.
Natural Resources Defense Council, 467 U.S. 837 (1984), reasoning that
``substantial deference'' was owed ``to the interpretation of the
authorizing statute by the agency authorized with administering it.''
500 U.S. at 184. Accordingly, it reaffirmed that ``[a]n agency is not
required to `establish rules of conduct to last forever,' but rather
`must be given ample latitude to `adapt [its] rules and policies to the
demands of changing circumstances.'' 500 U.S. at 186-187. The Court
declined to view the regulations skeptically because they represented a
change in policy; instead, the Court noted that it ``has rejected the
argument that an agency's interpretation `is not entitled to deference
because it represents a sharp break with prior interpretation' of the
statute in question.'' Id. The Court concluded that the regulations'
``program integrity'' requirements--the portions of the regulations
mandating separate facilities, personnel, and records--were ``based on
a permissible construction of the statute and are not inconsistent with
congressional intent.'' Id. at 188. Accordingly, the Court ``defer[red]
to the Secretary's reasoned determination that the program integrity
requirements are necessary to implement the prohibition.'' Id. at 190.
The Court further upheld the prohibition on abortion counseling and
referral, as well as the requirement of physical and financial program
separation, as consistent with the First Amendment. Id. at 192-198. The
Court held the ``Government has no constitutional duty to subsidize an
activity merely because the activity is constitutionally protected and
[Congress] may validly choose to fund childbirth over abortion and
`implement that judgment by the allocation of public funds' for medical
services relating to childbirth but not to those relating to
abortion.'' Id. at 201 (internal quotations omitted). The Court
concluded that the regulations were ``a permissible construction of
Title X.'' Id. at 203.
The 1988 regulations were operative until February 5, 1993, when
President Clinton suspended them pursuant to a Presidential Memorandum,
The Title X ``Gag Rule'', 58 FR 7455 (Feb. 5, 1993), and the Department
issued a proposed rule, Standards of Compliance for Abortion-Related
Services in Family Planning Service Projects, 58 FR 7464 (Feb 5, 1993),
that it finalized seven years later as the 2000 regulations. See 65 FR
41270 (July 3, 2000). The 2000 regulations essentially returned to the
1981 regulations (with one revision), which eliminated the provisions
of the 1988 regulations that (1) prohibited Title X projects from
counseling or referring project clients for abortion as a method of
family planning; (2) required grantees to separate their Title X
project physically and financially from any abortion activities; and
(3) implemented compliance standards for family planning projects under
Title X that specifically prohibit certain actions designed broadly to
promote or encourage abortion as a method of family planning, such as
the use of project funds to lobby for abortion, to develop and
disseminate materials advocating abortion, or to take legal action to
make abortion available as a method of family planning. While a
contemporaneous notice stated that more than separate bookkeeping
entries and allocation of funds was necessary to separate Title X
project activities from non-Title X abortion activities, that notice
nevertheless discussed and approved shared facilities, staff, and
records, as long as costs were pro-rated and properly allocated. See
Provision of Abortion-Related Services in Family Planning Service
Projects, 65 FR 41281, 41282 (July 3, 2000). The 2000 regulations also
required that Title X providers offer nondirective counseling on, and
referral for, abortion at the request of a Title X client, despite the
statutory prohibition on funding programs where abortion is a method of
family planning and the adoption of the Coats-Snowe Amendment in 1996
and Weldon Amendment in 2005, which prohibited the federal government
and State and local governments that receive federal financial
assistance from discriminating against health care entities that
refuse, among other things, to refer for abortion.
On December 19, 2016, the Department finalized a rule that amended
Title X eligibility requirements, requiring that no grantee making
subawards for the provision of services as part of its Title X project
prohibit an entity from receiving a subaward for reasons other than its
ability to provide Title X services. 81 FR 91852, 91860 (Dec. 19,
2016). The Department's stated reason for issuing the rule was to
respond to new approaches to competing or distributing Title X funds
that were being employed by several States. The 2016 regulation took
effect on January 18, 2017, but was nullified under the Congressional
Review Act, when the President signed the Joint Resolution of
Disapproval, on April 13, 2017. See Title X Requirements by Project
Recipients in Selecting Subrecipients, Public Law 115-23, 131 Stat. 89
(April 13, 2017).
On June 1, 2018, the Department published a proposed rule in the
Federal Register, through which it solicited public comments on
proposed changes to the 2000 Title X regulations and the formal
revocation of the 2016 regulation in accordance with the Joint
Resolution of Disapproval. See 83 FR 25502, 25504-25505 (June 1, 2018).
The Department believes the provisions of this final rule provide much
needed clarity regarding the Title X program's role as a family
planning program that is statutorily forbidden from paying for abortion
and funding programs/projects where abortion is a method of family
planning. The Department believes that the 2000 regulations fostered an
environment of ambiguity surrounding appropriate Title X activities.
This uncertainty was reflected in many of the public comments that
argued Title X
[[Page 7722]]
should support statutorily prohibited activities, such as abortion.
This rule rectifies the ambiguity created by the 2000 regulations.
Specifically, this rule:
Clearly delineates a bright line between Title X and non-
Title X activities;
provides grantees direction on how to ensure that no Title
X funds are expended where abortion is a method of family planning;
increases the ability of applicants to receive funding for
innovative projects that propose to serve underserved and unserved
populations; and
offers additional protection to patients who may be
victims of child abuse, child molestation, sexual abuse, rape, incest,
intimate partner violence, and human trafficking.
II. Statutory Authority, Overview, Analysis, and Response to Public
Comments
The Department provided a 60-day public comment period for the
proposed rule that closed on July 31, 2018. The Department received
over 500,000 public comments,\26\ which are posted at
www.regulations.gov. After considering the comments, the Department
finalizes the proposed rule with the changes discussed below. In this
preamble, the Department discusses the public comments, its responses,
and the text of the final rules.
---------------------------------------------------------------------------
\26\ This includes attachments and over 40 mass mailing or
internet comment generating campaigns, which accounted for more than
480,000 of the comments. The Federal Register docket lists only
205,000 comments; however a significant number of comments were
submitted in batches to www.regulations.gov.
---------------------------------------------------------------------------
The Department proposed to revise the authorities cited for the
regulations at 42 CFR part 59, subpart A, from ``42 U.S.C. 300a-4'', to
``42 U.S.C. 300 through 300a-6''. Some commenters support the
Department's authority to modify Title X regulations. Other commenters
contend that the Department does not have authority to make various
changes. The Department has legal authority under section 1006 of the
Public Health Service Act, 42 U.S.C. 300a-4, to promulgate and amend
regulations to implement the Title X family planning program, and
sections 1001 through 1008 of the Public Health Service Act (42 U.S.C.
300 through 300a-6) include substantive provisions which the Department
implements through such regulations. The Department has repeatedly
exercised its authority to issue regulations to guide Title X grantees
in carrying out the program. Section 1006 of the Act states that
``[g]rants and contracts made under this title shall be made in
accordance with such regulations as the Secretary may promulgate,'' and
section 1001 also specifies that the Secretary shall by regulation
specify certain rights to apply for grants or contracts. The grant of
regulatory rulemaking authority in section 1006 is sufficient authority
to support all of the requirements adopted through this final rule.
However with respect to various details of these final rules, the
Department also relies on section 1008 and other directives throughout
the Title X statute, as well as appropriations provisos and riders
governing the Title X program. The final rule is designed to refocus
the Title X program on its statutory mission--the provision of
voluntary, preventive family planning services specifically designed to
enable individuals to determine the number and spacing of their
children--while clarifying that women must be referred for appropriate,
medically necessary care identified during preconception screening and
for prenatal care services, since such care is important for both the
health of the women and for healthy pregnancy and birth. The Department
believes this final rule provides appropriate guidance for compliance
with such requirements.
Therefore, the Department finalizes, without change, its proposed
revision to the authorities cited for 42 CFR part 59, subpart A.
Comments supporting or challenging the Department's authority to
make particular changes are discussed in more detail in the relevant
sections below.
A. General Comments
While many comments were specific to certain sections of the
proposed rule, a sizeable number were more general in nature, or
commented on portions of the preamble, including content in the
background, the need for change, and the statutory authorities
sections. Those comments are summarized here, together with responses
by the Department. Many related comments are addressed in greater
detail further below, within the discussion of specific provisions of
the regulation.
Comments: Many commenters affirm the accuracy of the historical
record summarized by the Department in the proposed rule. This includes
the long-standing prohibition on promoting abortion in the Title X
program, the Supreme Court's upholding of the 1988 regulations in Rust
v. Sullivan, the Court's reaffirmation of Congress's general intent for
Title X to have a preconception focus, the legal precedent for the
government to favor childbirth over abortion (for example, Harris v.
McRae, 448 U.S. 297 (1980)), the continued bipartisan support for the
Title X statute, and the various supplemental requirements imposed by
Congress on the Title X program. Other commenters also contend that,
since Roe v. Wade, 410 U.S. 113 (1973), Title X grantees have
unlawfully treated abortion as a method of family planning despite
statutory prohibitions and that the 2000 regulations facilitate such
activity in violation of the Title X statute. Additional commenters
recall the history, purpose, importance, and value of Title X as the
sole federal program dedicated to funding family planning services for
low income individuals, including the provision of birth control,
cancer screening, sexually transmitted disease (STD) testing and
treatment, and other preventive care.
The Department received comments expressing diverse and conflicting
views on the proposed rule. Many commenters support the language of the
rule as proposed, so as to prevent taxpayer dollars from being used to
pay for activities related to abortion, contrary to the Title X
statute, and to provide the necessary transparency to assure Title X
funds are not used for abortion or abortion-related costs. Other
commenters assert that proposed changes could reduce access to
services, especially for the most vulnerable populations. Some
commenters note that the proposed rule closely mirrors the 1988
regulations, while others object to the proposed rule's provisions,
particularly on certain abortion referrals, and the similar but broader
provisions in the 1988 regulations, and point out that those provisions
were never fully implemented. Some commenters support the proposed rule
as providing much needed clarification to ensure adherence to the
original intent of Title X and to correct the regulations that were
issued in 2000. Other commenters contend that the proposed rule is
unnecessary, unjustified, unethical, and was proposed without evidence
of need.
Some commenters raised legal objections to the rule. Several
comments contend the Department's proposed rule is contrary to
congressional intent, violative of State sovereignty, and inconsistent
with the First Amendment rights of Title X grantees and the Fifth
Amendment rights of women. These commenters assert that women have a
constitutional right to abortions, and health care workers have a
responsibility to counsel individuals on the full scope of family
planning options.
Commenters assert that the proposed changes create ethical and
legal risks,
[[Page 7723]]
fail to follow professional standards of care for health professionals,
and violate conditions associated with federal grant funding under
section 330 of the Public Health Service Act.\27\ Commenters request
clarification on how broadly reporting requirements would apply,
specifically regarding referral agencies. They assert that Federally
Qualified Health Centers (FQHC), funded under Section 330 of the Public
Health Safety Act, are already required to provide significant data
reporting, including patient demographics, financial indicators, and
clinical quality. Commenters believe that the proposed Title X
reporting requirements would be potentially redundant with the existing
section 330 reporting requirements. Commenters also argue section 330
requires FQHCs to provide ``voluntary family planning'' services. This
rule, they argue, creates a conflict with that requirement by reducing
the family planning options, and potentially reduces the performance of
FQHCs by restricting their supplementary Title X funding.
---------------------------------------------------------------------------
\27\ See 42 U.S.C. 254b.
---------------------------------------------------------------------------
Others argue that the proposed rule would make it difficult to meet
national performance measures for the Title V Maternal and Child Health
Services Block Grant, which serve as a measure of our country's
progress on adolescent annual preventive medical visits. Still other
commenters argue the proposed rule violates the APA on multiple
grounds, including that the rule is arbitrary and capricious, and they
assert that the Department has not provided adequate reasons for its
rulemaking by examining the relevant data and articulating a
satisfactory explanation for its action, including a rational
connection between the facts found and the choices made. Several
commenters urge the Department to withdraw the proposed rule. Some
commenters contend the rule is not legally supportable and that, if the
Department finalizes the rule, it will be challenged in court.
In contrast, other commenters argue that the proposed rule closely
tracks the 1988 regulations, which were upheld on both statutory and
constitutional grounds by the Supreme Court. Those commenters argue
that the proposed rule is just as constitutional now as it was then,
and observe that many other cases have affirmed the principle that the
government is not obligated to fund or facilitate abortions.
Numerous commenters state that the Department has spent much time
and effort to craft a solution where there is no problem to be
addressed. They claim Title X has never funded abortions, and Title X
providers fully understand what the statutes and 2000 regulations
require. They state that examples of the misuse of Title X funds are
not well founded. Several commenters state that, under the comment
filing deadline of July 31, 2018, they were unable to evaluate the full
extent of the impacts of the Notice of Proposed Rule Making (NPRM) on
affected communities. These commenters requested that the Department
extend the comment period an additional 60 days, or to October 1, 2018.
They contend this extension would provide the Department more time to
hear from impacted populations on changes to Title X. One commenter
contends their extension request was due to the Department rushing the
publication of the proposed rule, and engaging in insufficient public
engagement with stakeholders prior to the release of the rulemaking.
Another commenter mentions they were requesting an extension because
they experienced issues with submitting their comments electronically.
Response: The Department notes that there is, generally, a common
understanding regarding the history and the purpose of the Title X
program, together with the sharp diversity of opinion regarding the
need for revisions to the 2000 regulations. The Department appreciates
the emphasis many comments place on Title X's role in caring for low
income individuals by providing a broad range of family planning
methods and services. The Department concludes these final rules will
contribute to more clients being served, gaps in service being closed,
and improved client care that better focuses on the family planning
mission of the Title X program. The Department expects these positive
outcomes, in part, because the Department believes (1) program
parameters will be more clear; (2) new applicants will apply to serve
unserved or underserved patients and/or less concentrated population
areas because the review and selection criteria will no longer skew in
favor of heavily populated areas; (3) new providers who previously were
unable to participate in Title X projects due to conscience concerns
with the 2000 regulations will be free to apply for a Title X grant or
to participate in a Title X project; (4) Title X providers will be more
likely to provide comprehensive primary care services or refer to
primary health providers who can fulfill non-Title X needs in close
proximity to the clinics, furthering overall health care of patients;
and (5) the broad and clear definition for ``family planning'' will
enable grantees to better provide a broad range of family planning
methods and services to meet the needs and desires of more patients.
The Department believes that the final rule represents a better
interpretation of the statutory provisions applicable to the Title X
program than the 2000 Regulations. The rule permits and will encourage
better and closer compliance with these legal obligations on the part
of grantees and their subrecipients. The Department agrees with
comments stating that the proposed rule is necessary to protect the
integrity of the Title X program, and the Department has authority to
take such action, as discussed above and supported by case law.\28\ The
Spending Clause of the Federal Constitution provides Congress authority
to spend monies and to impose conditions and requirements with respect
to the expenditures of funds,\29\ and it has exercised this authority
to create the Title X program and impose conditions upon it. The
Department has, in turn, exercised its legal authority \30\ to issue
regulations to guide Title X grantees in carrying out the program. The
rule will ensure adherence to the statutory provisions adopted by
Congress for the Title X program.
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\28\ See Rust, 500 U.S. at 193.
\29\ Art. 1, sec. 8, cl. 1.
\30\ See 42 U.S.C. 300a-4.
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The Department agrees with comments that section 1008 establishes a
broad prohibition on funding, directly or indirectly, activities that
treat abortion as a method of family planning.\31\ The Department also
agrees with comments that the 2000 regulations are inconsistent with
that interpretation insofar as they require referral for abortion as a
method of family planning, allow the use of funds for building
infrastructure that could be used for abortion services, and do not
require clear physical separation between Title X activities and
abortion-related services.\32\ The Department
[[Page 7724]]
notes that the 2000 regulations also do not ensure transparency and
accountability in the use of taxpayer funds since they fail to require
grantees to provide the Department with information about
subrecipients, to ensure monitoring for potential misuse of funds and
for compliance with federal laws (including a Title X-specific
appropriations provision) that prohibit the use of taxpayer funds for
political activity or lobbying. Finally, the 2000 regulations prescribe
inadequate grant application review criteria for selecting grantees of
Title X funds who will comply with all of these requirements.
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\31\ See 42 U.S.C. 300a-6.
\32\ As described in the preamble to the 1988 regulations, 53 FR
at 2923, prior to issuance of any regulations pursuant to Title X,
the Department had, since 1972, interpreted section 1008 not only as
prohibiting the provision of abortion, but also as prohibiting Title
X projects from in any way promoting or encouraging abortion as a
method of family planning. Further, based on the legislative
history, the Department had also, since 1972, interpreted section
1008 as requiring that the Title X program be ``separate and
distinct'' from any abortion activities of a grantee. However, in
such interpretations, the Department generally took the view that if
activity did not have the immediate effect of promoting abortion, or
which did not have the principal purpose or effect of promoting
abortion, it was permitted in a project. See GAO, No. HRD-82-106,
Restrictions on Abortion and Lobbying Activities in Family Planning
Programs Need Clarification, at 22 (Sept. 24, 1982), https://www.gao.gov/assets/140/138760.pdf.
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The Department believes that the final rule is a reasonable
interpretation of the Title X statute and applicable laws in light of
the express statutory terms, legislative history, and case law
regarding the implementation and enforcement of provisions such as
section 1008. The express terms in section 1008 reasonably support the
Department's conclusion that there must be a separation between Title X
projects and funds and any project where abortion is a method of family
planning. See 42 U.S.C. 300a-6. The express terms of section 1008 also
reflect the congressional purpose that Title X primarily has a
preconception focus and should fund and, thereby, encourage
preconception services. See Rust, 500 U.S. at 190 (``It is undisputed
that Title X was intended to provide primarily prepregnancy preventive
services.''). This focus on preconception care generally excludes
payment for postconception care and services, though it can allow the
provision of information and counseling in a postconception context, or
access to postconception services outside the Title X project, if Title
X's restrictions concerning abortion as a method of family planning are
maintained. It is, thus, no surprise that the Supreme Court concluded
that the 1988 regulations' ``program integrity'' requirements, which
are substantially similar to the ones adopted in this final rule--
including the portions of the regulations mandating separate
facilities, personnel, and records--were ``based on a permissible
construction of the statute and are not inconsistent with congressional
intent.'' Id. at 188. The Court noted that, ``if one thing is clear
from the legislative history, it is that Congress intended that Title X
funds be kept separate and distinct from abortion-related activities. .
. . Certainly, the Secretary's interpretation of the statute that
separate facilities are necessary, especially in light of the express
prohibition of Sec. 1008, cannot be judged unreasonable.'' Id. at 190.
The Court ``defer[red] to the Secretary's reasoned determination that
the program integrity requirements are necessary to implement the
prohibition.'' Id. The Department now reaffirms that reasoned
determination and reaches similar conclusions here.
The Department disagrees with commenters who contend the proposed
rule (or this final rule) violates the Constitution and the intent of
Title X. The Supreme Court rejected similar constitutional challenges
to the 1988 regulations. As an initial matter, it upheld the statutory
limitation of Title X funds to programs where abortion is not a method
of family planning, concluding that ``[t]here is no question but that
the statutory prohibition contained in Sec. 1008 is constitutional''
because Congress ``may `make a value judgment favoring childbirth over
abortion, and . . . implement that judgment by the allocation of public
funds.' '' Id. at 192 (internal citations omitted; ellipsis in
original). The Court further explained that the provisions in the 1988
regulations barring counseling and referral were consistent with the
First and Fifth Amendments. Id. at 193-94, 203. The Department believes
the Court's analysis encompasses, and is equally applicable to, the
provisions of this final rule for similar reasons.
The Department disagrees with commenters contending the proposed
rule, to the extent it is finalized here, infringes on the legal,
ethical, or professional obligations of medical professionals. Rather,
the Department believes that the final rule adequately accommodates
medical professionals and their ethical obligations while maintaining
the integrity of the Title X program. In general, medical ethics
obligations require the medical professional to share full and accurate
information with the patient, in response to her specific medical
condition and circumstance. Under the terms of this final rule, a
physician or APP may provide nondirective pregnancy counseling to
pregnant Title X clients on the patient's pregnancy options, including
abortion. Although this occurs in a postconception setting, Congress
recognizes and permits pregnancy counseling within the Title X program,
so long as such counseling is nondirective. The permissive nature of
this nondirective pregnancy counseling affords the physician or APP the
ability to discuss the risks and side effects of each option, so long
as this counsel in no way promotes or refers for abortion as a method
of family planning. It permits the patient to ask questions and to have
those questions answered by a medical professional. Within the limits
of the Title X statute and this final rule, the physician or APP is
required to refer for medical emergencies and for conditions for which
non-Title X care is medically necessary for the health and safety of
the mother or child.
The Department appreciates comments expressing concern about
administrative reporting burdens on FQHCs who receive funding under
both Section 330 and Title X. However, different federal programs often
have different reporting and other requirements, depending on the
specific statutory requirements and constraints. The fact that some
federal grant programs may require more (or less) to qualify for
funding is an appropriate reflection of Congressional direction. The
Department is mindful of the administrative burden when establishing
requirements for federal grant programs and seeks, as possible, to
impose substantially the same administrative requirements on grant
programs. However, it is under no obligation to impose the same
requirements for multiple grant programs; rather, it is guided by the
statutory requirements placed by Congress regarding each individual
federal grant program. To the extent that requirements overlap, the
Department believes that no additional burden results because the
information can be readily shared within the grantee organization.
Where the Title X program imposes additional requirements, these
additional requirements are the result of specific statutory
requirements applicable to the Title X program. The Department believes
that these additional requirements are reasonable in light of those
specific statutory requirements and the Department's need to ensure
compliance with such requirements.
The Department also believes that concerns that Title X will
conflict with Section 330's voluntary family planning requirements are
unfounded. This final rule continues the historical Title X emphasis
that family planning must be voluntary--the definition of ``family
planning'' adopted by the final rule and, thus, applicable to the Title
X program explicitly states that ``family planning methods and services
are never to be coercive and must always be strictly voluntary.'' This
final rule also confirms the statutorily mandate that a ``broad range''
of family planning methods and services be available under Title X.
This requirement also supports the voluntary
[[Page 7725]]
nature of family planning by providing a variety of methods and
services so that the individual patient can make an informed choice,
based on her own lifestyle and needs. To the extent that limitations
are imposed on the Title X program (e.g., abortion provisions), the
Department has carefully designed these to enforce explicit statutory
mandates applicable to Title X. However, the Department intends to
continue emphasizing the broad range of family planning methods and
services as a way to fulfill the various family planning needs of
patients who visit the many Title X clinics across the nation. Thus,
the Department finds that section 330 and Title X are complementary in
this respect.
The Department does not agree that the final rule will impede the
ability of States and jurisdictions to meet the national performance
measure (NPM) for annual adolescent preventive well visits for the
Title V Maternal and Child Health Services Block Grant. Some commenters
contend that any limitation on a patient's ability to access affordable
health care at their preferred site of care for family planning
services or to meet with the provider of their choice for preventive
health care will impede States' ability to meet their goals for the
well-woman visit NPM and the adolescent well-visit NPM for Title V. But
by encouraging Title X projects to offer either comprehensive primary
health care services onsite or have a robust referral linkage with
primary health care providers who are in close proximity to the Title X
site, the Department believes this final rule should reinforce States'
ability to meet their goals for well-woman and adolescent well-visit
NPMs. Furthermore, the Department does not believe that the rule will
limit the ability of individuals to access affordable health care;
thus, achievement of the NPM will remain unaffected by the changes in
regulation. The Title X program currently provides services to
adolescents and will continue to provide these services.
The Department agrees with comments stating that demonstrated
abuses of Medicaid funds do not necessarily mean Title X grants are
being abused and did not make that argument in the proposed rule.
Rather, the Department believes that examples of abuse in other Federal
programs help illustrate the need for clarity with respect to
permissible and impermissible activities in connection with the Title X
program and Title X funds, especially where the 2000 regulations foster
confusion and ambiguity.\33\ Title X is a grant program where funds are
disbursed before completion of the service, increasing the possibility
of intentional or unintentional misuse of funds. Appropriate
accountability standards are particularly appropriate in the case of
grant programs such as Title X.
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\33\ ``. . . [A]udits have found overbilling . . . improper
practices resulting in significant Title XIX-Medicaid overpayment .
. . [and] ``unbundling'' or ``fragmentation'' billing schemes
related to pre-abortion examinations, counseling visits, and other
services performed in conjunction with an abortion, and improper
billing for the abortions themselves.'' See Foster, Profit. No
Matter What, 2017 Report on Publicly Available Audits of Planned
Parenthood Affiliates and State Family Planning Programs, Charlotte
Lozier Institute Special Report Series 3 (Jan. 4, 2017), https://lozierinstitute.org/profit-no-matter-what (summarizing evidence from
publicly available audits). These examples of abuse illustrate the
need to clarify any confusion or ambiguity that may cause or add to
the problems uncovered by the auditors.
---------------------------------------------------------------------------
The Department's reasons for deciding to revise the 2000
regulations go beyond evidence regarding abuses of Medicaid funds by
entities that are also Title X grantees or subrecipients, and are
discussed in more detail below. These additional reasons include the
Department's view that Title X grantees must be financially transparent
and accountable throughout the grant disbursement process, rather than
only after the grant is spent. The Department has a compelling interest
in ensuring that, from the moment of disbursal, Title X funds are used
only for permissible activities under the Title X statute,\34\ rather
than condoning after-the-fact correction and bookkeeping adjustments.
The Department disagrees with some commenters who characterize the
government's pursuit of this interest as ``restricting abortion
rights''; the Supreme Court rejected similar arguments and challenges
to similar provisions in the 1988 regulations. See Rust, 500 U.S. at
177-178 (upholding similar Title X ``program integrity'' requirements).
---------------------------------------------------------------------------
\34\ 42 U.S.C. 300a-6.
---------------------------------------------------------------------------
The Department also seeks to remedy the potential for confusion,
under the 2000 regulations, about whether Title X funds can be, or are
being used, in a project where abortion is a method of family planning.
It does so by finalizing the rule to strengthen the requirements for
financial separation and to preclude shared physical space and staff
with respect to abortion. It also does so by improving grant
monitoring, including fiscal and internal controls, to prevent the
misuse of taxpayer funds. The Title X program is not unique in the need
for such grant monitoring to identify and prevent such misuse. However,
particularly because providing abortion as a method of family planning
has been statutorily prohibited,\35\ and abortion is a source of
contentious public debate, the Department believes improved
accountability measures are a useful and responsible action that will
expand taxpayers' trust in the Title X program.
---------------------------------------------------------------------------
\35\ Id.
---------------------------------------------------------------------------
In response to commenters who contend the rule will be challenged
in court, the Department believes the Supreme Court's decision in Rust
provides broad support for the approach taken in this rule. Although
the rule differs in some respects from the 1988 regulations upheld in
Rust, some of those differences arise from the Department's desire to
implement statutory provisions that did not exist at the time the 1988
regulations were adopted. Other differences, such as the permission for
nondirective pregnancy counseling--which implements an appropriations
rider that was adopted as early as 1996 \36\ and has been regularly
included in HHS's appropriations through fiscal year 2019--are more
permissive than the 1988 regulations and less susceptible to the type
of challenges that plaintiffs brought (unsuccessfully) in Rust. Other
changes concern issues not directly addressed in Rust, but plainly
supported by the Department's discretion to implement the program as
set forth in Title X and applicable statutes. The Department believes
that each component of the rule is legally supportable, individually
and in the aggregate. To the extent a court may enjoin any part of the
rule, the Department intends that other provisions or parts of
provisions should remain in effect.
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\36\ Omnibus Consolidated Rescissions and Appropriations Act of
1996, Public Law 104-134, 110 Stat. 1321, 1321-221 (stating that
``amounts provided to said projects under such title shall not be
expended for abortions, that all pregnancy counseling shall be
nondirective, and that such amounts shall not be expended for any
activity (including the publication or distribution of literature)
that in any way tends to promote public support or opposition to any
legislative proposal or candidate for public office.''). The 2019
Appropriations Act contains the same directive.
---------------------------------------------------------------------------
The Department disagrees with commenters who state that the 60-day
comment period was insufficient. The APA does not have a minimum time
period for comments, and 60-day comment periods are used for large
numbers of very significant rules, including rules that contain far
more complicated and complex proposed requirements. The comment period
closed 60 days after publication of the proposed rule in the Federal
Register on June 1, 2018, but the proposed rule went on display at the
Office of the Federal
[[Page 7726]]
Register on June 1, 2018 and on the Department's website on May 22,
2018. The comment period provided ample time for the submission of over
500,000 comments by a variety of interested parties, including
extensive comments by a number of entities. Those comments offer a
broad array of perspectives on the full range of issues raised in the
proposed rule. After reviewing the public comments and the requests for
additional time, the Department does not believe that extending the
comment period is or was necessary for the public to receive sufficient
notice of, and opportunity to comment on, the proposed rule. Nor is
there anything in the statutory provisions governing the Title X
program that would have required additional outreach outside of the
public notice and comment process and the comment period. Consequently,
the Department concludes that the comment period was legally sufficient
and is not extending the comment period.
B. To what programs do these regulations apply? (42 CFR 59.1)
Summary of changes: The original language of the 2000 regulations
at Sec. 59.1 remains intact. The proposed rule proposed to add that,
unless otherwise noted, Title X program requirements and regulations
would apply equally to grantees and their subrecipients and that
grantees would be responsible for ensuring that the entire project,
which includes all subrecipients, complies with the Title X
regulations. With certain exceptions, the proposed rule also provided
that the regulatory requirements of Title X would apply equally to any
contracts established under Section 1001 to carry out a Title X
project. The Department finalizes the proposed changes to Sec. 59.1
with slight technical changes to clarify the language regarding the
requirements for grantees and subrecipients.
Comments: Some commenters question the need for the proposed
changes. They state that the Department is not lacking information
about subrecipients, as the Department already publishes a directory
listing all subrecipients online. Some commenters contend that
previously, the Department's legal relationships have been with Title X
grantees concerning project operations only, not with subrecipients.
Several commenters state that the rule gives unprecedented
information and regulatory authority to the Department regarding Title
X grantees and subrecipients. Some commenters assert that the
regulations attempt to give the Department unchecked discretion to
disqualify applications. Several commenters contend the proposed rule
would impose burdensome and redundant bureaucratic responsibilities on
grantees and would limit the participation of certain providers. Some
commenters object to the application of the rule to subrecipients,
contending it will impose unacceptable burdens on subrecipients and
drive qualified providers from Title X projects.
One commenter believes that treating grants and contracts equally
will circumvent fair contracting rules, expediting allocation of funds
to organizations and programs that do not submit applications as part
of a competitive procurement or that will not be required to follow
program regulations, including basic eligibility guidelines. The
commenter states that, if implemented, this change could drastically
alter the landscape of Title X providers, potentially allowing, among
other things, for-profit organizations and health care providers that
do not meet the highest standards of quality care to be awarded federal
funds through a non-competitive process. One commenter states the
proposed rule does not adequately discuss the regulatory or economic
impact of applying the same requirements of contracts as family
planning grants to entities, as contract and grant regulations differ.
One comment states that the proposed rule does not address whether
Title X funds used for contracts would offset funds used for grants.
Response: The Department disagrees with commenters who contend that
the Department already has sufficient information about subrecipients.
Although an online directory lists subrecipients, important information
about the grant project is not reported at a granular level. The
Department does not know the scope of services provided by individual
subrecipients, nor the degree of compliance with statutory and
regulatory requirements by individual subrecipients. The Department
maintains it is reasonable and appropriate to require additional
transparency in these areas to ensure accountability for, and
compliance with, the statutory integrity provisions applicable to the
Title X program. Moreover, it is quite common for regulatory
requirements to flow down from grantees to subrecipients; this final
rule simply makes that expectation explicit.
The Department also does not agree with some commenters contending
that these regulations are unnecessary, redundant, or overly
burdensome. As discussed more below, the Department has a duty to
ensure that Title X funds are spent in accordance with statutory
requirements; that duty applies equally to Title X funds used by
grantees and subrecipients. The final rule helps the Department fulfill
that duty and thereby to ensure the proper accounting of Title X funds.
The Department believes there has been insufficient transparency and
accountability in the use of taxpayer funds because grantees have not
been required to provide the Department with sufficient information
about subrecipients, to ensure monitoring for potential misuse of
funds, or to address express statutory program integrity provisions and
limitations (including a Title X specific appropriations provision)
that, among other things, prohibit the use of taxpayer funds for
political activity or lobbying. The final rule will redress these
insufficiencies and improve the transparency and accountability that
surrounds the use of Title X funds.
The Department concludes that the final rule appropriately requires
that the program integrity provisions of Title X family planning
program apply to projects whether they are established by grants or
contracts and to any entity receiving Title X funds. The Department
disagrees that the application of Title X regulations to the execution
of contracts is an exercise of improper or unprecedented regulatory
authority. Title X authorizes the Secretary to carry out the Title X
program by entering into contracts with, or issuing grants to, public
or private nonprofit entities and to promulgate regulations governing
grants and contracts issued in the program. 42 U.S.C. 300(a), 300a-4.
Thus, the Department has the authority to issue regulations governing
the program, including provisions that apply statutory requirements
both to grantees and contractors, and subrecipients of Title X funds.
With respect to subrecipients, since grantees in most instances do not
directly provide Title X services, the only way to ensure compliance
with the statutory and regulatory requirements is to require the
inclusion of provisions in contracts with, or grants to, subrecipients
that require such compliance. Such flow-down requirements are a
commonly used mechanism in the Department's grant programs to ensure
that the programs are properly implemented. The Department believes
that ensuring Title X funds are expended by subrecipients consistent
with the statutory and regulatory parameters is a responsibility that
all Title X grantees reasonably assume when they extend the financial
benefits of the program to another party.
[[Page 7727]]
The Department disagrees with commenters that challenge the
Department's oversight role in the proposed rule. Title X grantees must
ensure adequate oversight of Title X funds, including the use of those
funds by subrecipients. The statutory restrictions imposed on the use
of Title X funds cannot be avoided by distributing the funds to
subrecipients. The Department is committed to ensuring all rules
governing Title X funds are applied to both primary grantees and
subrecipients. The Department does not agree with commenters who state
that the administrative cost of ensuring that subrecipients are
compliant with Title X is overly burdensome. Although there may be
additional costs involved with these oversight measures, specifying
that grantees are responsible for ensuring the compliance of their
subrecipients does not add an additional requirement; it merely makes
more explicit the fact that grantees are already responsible for
ensuring the compliance of their Title X projects with the statutory
and regulatory requirements applicable to Title X projects. The
specific oversight measures required by this final rule are reasonable
and necessary to ensure such compliance with the Title X requirements
and proper accountability of Title X funds. The costs associated with
those measures are detailed below.
The Department disagrees that the rule will exclude qualified
providers from providing Title X services since any eligible
organization may apply to provide Title X services, so long as it
complies with the requirements set forth in the statute, related
regulations, and the funding announcement. The Department disagrees
with commenters who suggest oversight will hinder the participation of
health centers, except to the extent that they are not compliant with
Title X requirements. An organization that qualifies under Title X to
provide statutorily appropriate services may also provide non-Title X
services, so long as they do so in a manner that complies with the
Title X regulations. The Department believes that the provisions of the
final rule will result in expanded preconception family planning
options available to individuals consistent with the Title X program's
explicit mandate.
The Department has considered the comments that express concern
about the proposed language that treats Title X contracts and grants
equally, but concludes that a plain reading of the statute supports
that approach. Title X authorizes the Secretary to award grants and/or
enter into contracts to establish and operate voluntary family planning
projects--and then authorizes the Secretary to adopt regulations to
implement the Title X program.\37\ The Department interprets this grant
of authority to afford it flexibility in choosing the vehicles to
implement the Title X statute, but not to allow funding vehicles that
avoid the requirements of the Title X program. Grants and contracts are
entered into under different general procedures and are governed by
different sets of procedural law. Title X projects, however, whether
implemented by grant or contract, must comply with applicable
substantive requirements of the Title X statute, which these
regulations implement.
---------------------------------------------------------------------------
\37\ See 42 U.S.C. 300(a), 300a-4(a).
---------------------------------------------------------------------------
Accordingly, regardless of whether the Department enters into a
grant or contract, requirements of the Title X program shall apply,
except for Sec. Sec. 59.4, 59.8, and 59.10. For example, the
Department interprets section 1008 of Title X to require certain
restrictions concerning abortion referrals, and physical and financial
separation between Title X activities and activities not permitted
under the Title X statute. That interpretation would apply to project
activities whether they are undertaken by grant or by contract. This
regulatory provision applying certain sections of this rule to
contracts is necessary to ensure consistency in the implementation and
enforcement of Title X statutory program integrity provisions if a
project is implemented through the issuance of a contract.
The Department notes comments that draw distinctions between grants
and contracts in the general regulatory system and how they serve
different purposes. The Department recognizes these differences exist,
but for reasons stated above, believes it necessary to ensure the basic
requirements of the Title X program are consistent. Title X authorizes
the Secretary to enter into contracts, not just grants, to implement
the program.\38\ The Department believes it is necessary to treat
contracts and grants similarly for both grantees (or, in the case of
contracts, contractors) and subrecipients or subcontractors.
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\38\ See 42 U.S.C. 300(a).
---------------------------------------------------------------------------
The Department disagrees with commenters who contend the proposed
rule would circumvent ordinary procurement procedures. The Department's
purpose in adding the provision on its ability to carry out a Title X
program/project by contract was not to evade or avoid the substantive
requirements imposed by Title X or these regulations--the Department,
for example, could not contract with a for-profit entity to carry out a
Title X program or project because that would be inconsistent with 42
U.S.C. 300(a)--but to confirm that contracts to implement the Title X
program must be consistent with, and implement, the substantive
requirements entailed in these regulations, including those related to
the prohibition on the use of funds for projects where abortion is a
method of family planning. If the Department enters into contracts, it
would do so based on other rules generally applicable to contracts,
except as specified in the Title X statute or these regulations. Thus,
for example, any contracts issued under Title X would continue to be
competitive to the extent required by law and regulation. To make that
clear, the proposed rule would provide that certain sections of part 59
subpart A would not apply to contracts because those sections address
processes specifically applicable to grants and grant applications. The
substantive requirements of the other sections of the subpart, in
contrast, would apply to Title X projects or programs, regardless of
whether they are carried out by grant or contract.\39\
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\39\ Although the Department had proposed that Sec. 59.3 would
not be applicable to contractors carrying out a Title X project,
after further consideration, and in light of the public comments,
the Department now believes that such contractors should be required
to comply with Sec. 59.3. Accordingly, the Department does not
include that section in the list of regulatory provisions that would
not apply to entities who have contracted with the Department to
implement a Title X project. This is discussed in more detail below
in response to comments concerning Sec. 59.3.
---------------------------------------------------------------------------
Accordingly, the Department expects both grantees and contractors
to ensure that Title X funds are spent on statutorily appropriate
activities. The proposed rule and this final rule help to ensure that
this expectation is met by formalizing those requirements and that
process.
One commenter had inquired about how the issuance of a contract to
implement a Title X project would affect Title X grants. Since the
funds for the program are fixed by appropriations, funds used for
contracts in a given fiscal year would not be used for grants, and vice
versa. Thus, Title X funds used for contracts would be offset from
funds used for grants, as stated in the proposed rule.
C. Definitions (42 CFR 59.2)
1. Definition of Advanced Practice Provider
Summary of changes: The 2000 regulations did not define ``advanced
practice provider,'' and the Department had not proposed such a
definition in the proposed rule. However, as a result
[[Page 7728]]
of comments on the type of medical professional who could provide
nondirective counseling and referrals under the proposed rule, as
discussed in greater detail below, the Department has determined that,
in addition to medical doctors, advanced practice providers (APPs) may
provide nondirective counseling and referrals. For greater clarity on
the scope of such APPs who can provide such services in Title X
projects, the Department defines APPs to include those medical
professionals who receive at least a graduate level degree in the
relevant medical field and maintain a federal or State-level
certification and licensure to diagnose, treat, and counsel patients.
The term APP includes physician assistants and advanced practice
registered nurses (APRN) who are performing increasingly critical roles
within the health care system.\40\ Examples of APRNs that qualify as an
APP include Certified Nurse Practitioner (CNP), Clinical Nurse
Specialist (CNS), Certified Registered Nurse Anesthetist (CRNA), and
Certified Nurse-Midwife (CNM).\41\ These APPs are qualified, due to
their advanced education, licensing, and certification to diagnose and
treat patients while advancing medical education and clinical
research.\42\ The final rule establishes this definition for purposes
of Title X in Sec. 59.2.
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\40\ Other Federal Agencies refer to APPs as Mid-Level
Practitioners. See U.S. Department of Justice Drug Enforcement
Diversion Control Division, Mid-Level Practitioners Authorization by
State, Drug Enforcement Administration, https://www.deadiversion.usdoj.gov/drugreg/practioners/index.html. ``Mid-
Level Practitioners'' and ``Advanced Practice Provider'' generally
describe the same group of individuals; the Department here chooses
the latter term in recognition of the increasingly critical and
advanced roles that PAs and APRNs play within the clinic
environment.
\41\ The Department recognizes the wide range of specializations
within the nursing profession. These examples were selected as APPs
due to their advanced medical degrees, licensing, and certification
requirements. See National Council of State Boards of Nursing, APRNS
in the U.S, https://www.ncsbn.org/aprn.htm. See also American
Association of Nurse Practitioners, What's a Nurse Practitioner
(NP)?, https://www.aanp.org/about/all-about-nps/whats-a-nurse-practitioner (stating that ``[a]ll NPs must complete a master's or
doctoral program and have advanced clinical training beyond their
initial professional registered nurse preparation'' while being
regulated by the licensing requirements of each State where the
individual practices).
\42\ See, Catherine S. Bishop, Advanced Practitioners Are Not
Mid-Level Providers, J Adv Pract Oncol, (Sept. 1, 2012), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4093350/ (noting that Physician
Assistants and Advanced Practice Nurses ``have at least a master's
degree and many hold doctorates.'') See also Jacquelyn Corley,
Advanced-Practice Providers Are Key to America's healthcare Future,
Forbes, (Mar. 16, 2017), https://www.forbes.com/sites/realspin/2017/03/16/advanced-practice-providers-are-key-to-americas-healthcare-future/#3d25c1f95998.
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2. Definition of Family Planning
Summary of changes: The 2000 regulations do not define ``family
planning.'' The proposed rule, at Sec. 59.2, proposed to define
``family planning'' as ``the voluntary process of identifying goals and
developing a plan for the number and spacing of children and the means
by which those goals may be achieved.'' Further, the proposed
definition included ``a broad range of acceptable and effective
choices, which may range from choosing not to have sex to the use of
other family planning methods and services to limit or enhance the
likelihood of conception (including contraceptive methods and natural
family planning or other fertility awareness-based methods) and the
management of infertility (including adoption).'' Family planning
services are described in the proposed definition to include
``preconception counseling, education, and general reproductive and
fertility health care to improve maternal and infant outcomes, and the
health of women, men, and adolescents who seek family planning
services, and the prevention, diagnosis, and treatment of infections
and diseases which may threaten childbearing capability or the health
of the individual, sexual partners, and potential future children).''
Family planning and family planning services are to be voluntary and
never coercive. The proposed rule emphasizes that family planning
``does not include postconception care (including obstetric or prenatal
care) or abortion as a method of family planning. Family planning, as
supported under this subpart, should reduce the incidence of
abortion.'' The proposed rule indicates that prenatal referrals are
required and medically necessary for the health of the pregnant mother,
as well as the unborn baby, and are not included in this prohibition.
The Department finalizes this definition with changes, including
clarifying the role of adoption as a family planning activity by
permitting Title X providers to provide information about or referrals
for adoption as a Title X service; increasing the understanding that
family planning must not be coercive and must always be voluntary; and
by making technical edits for consistency and readability.
Comments: Some commenters state there is little support for the
Department to define family planning. They note that, while the
Department says the definition's purpose is to avoid the ``risk of the
intentional or unintentional use of Title X funds for impermissible
purposes,'' the Department cites no actual violation of Title X
requirements in relation to the provision of abortion services.
Some commenters oppose the explicit exclusion of abortion in the
definition. One commenter notes that abortion does impact the number
and spacing of children and should not be excluded from the meaning of
family planning. Such commenters state that couples use abortion as a
method of family planning to determine their desired number of children
or to space them. They contend that excluding abortion from the
definition by labeling it postconception care reflects a failure to
consider who may want or need to have an abortion. Additionally, one
commenter states that the last sentence of the new definition should be
stricken because reducing abortion was not the intent of the enabling
legislation. Some commenters suggest the definition creates ambiguity
concerning abortion that is not used as a method for family planning.
Many commenters ask the Department to eliminate language that
mentions natural family planning and fertility awareness-based methods
(FABMs), contending that the definition prioritizes those methods over
other contraceptive methods. Such commenters worry that the definition
de-emphasizes contraception in favor of abstinence, natural family
planning, and fertility awareness-based methods that the agency has
long recognized are less-effective methods of family planning.
Commenters also contend, for example, that fertility awareness-based
methods do not fit everyone's lifestyle and are ineffective for many
women; that abstinence programs are ineffective and ignore the needs of
participants already engaged in sexual activity; that avoiding sex as a
family planning method conflicts with CDC, WHO, and UN definitions of
family planning; and directing Title X funds towards natural family
planning is unnecessary as 93% of sites report offering it and less
than 0.5% of female Title X contraceptive users rely on it.
Some commenters ask, in the alternative, that if the Department
does not eliminate language that mentions natural family planning, the
Department instead clarify whether it intends to prioritize and promote
natural family planning and other FABMs for Title X patients over other
contraceptive options, and if so, to provide its justification, and
explain why that would not undermine patients' ability to obtain
voluntary care free from coercion. Some commenters also state that the
proposed language may ``blur the lines'' between choices, methods,
[[Page 7729]]
and services, and contend this may diminish the range of each provided
under the Title X program.
One commenter says the definition of family planning should ensure
that women have sufficient access to evidence-based family planning and
sexual health information, and the full range of medically accepted
forms of contraception, in order to avoid issues that may arise in
light of the new definition of family planning. Commenters express
concern that the definition would leave many women without access to
contraception or the most effective methods to prevent pregnancy. Other
commenters oppose the definition of family planning because they
contend negative impacts will result, such as driving some providers
out of business; increasing the incidence of unintended pregnancy;
increasing the incidence of sexually transmitted diseases; leading to
grantees offering a more limited scope of services, making it difficult
for patients to receive care they need; and leading to increased costs
on the health care system as the result of unintended pregnancies.
One commenter supports including only preconception services in the
definition of family planning, and states that the definition empowers
the Department and Title X providers to provide comprehensive services.
Another commenter similarly states that, by placing postconception care
beyond the scope of Title X, and by expressly excluding abortion from
the definition of family planning, the definition reorients Title X
towards its intended purpose.
Other commenters oppose including only preconception services in
the definition. One commenter contends that excluding postconception
care disrupts the continuity of care for family planning clients. The
commenter additionally states the limitation is contrary to national
standards that promote early access to prenatal care. Another commenter
argues that the government is discriminating against women who seek
abortions by defining the practice as postconception care and excluding
this type of care from the definition of family planning, but then
requiring projects to refer all pregnant woman for prenatal care.
Some commenters request that the Department eliminate language
referring to adoption. Commenters assert that the management of
infertility, including adoption, exceeds the intent of the program as
its inclusion is beyond the language of the Title X statute. Including
adoption would put a strain on the program, commenters contend, as it
would redirect a large amount of Title X funds. Additionally,
commenters contend adoption is a postconception activity, and say its
inclusion in the definition contradicts the definition's statement that
family planning only includes preconception activities.
Some commenters also argue that excluding abortion is a violation
of the First Amendment's religion clauses due to preferring some
religious ideas over others and enforcing religion with the power of
the government. They contend excluding abortion, and in their view
emphasizing natural family planning, is characteristic of particular
religious views.
Finally, one commenter states that the rule does not make it clear
whether female or male sterilization services are considered within the
scope of family planning methods, and contends they are consistent with
the goal of determining the number and spacing of one's children.
Response: Title X of the Public Health Service Act confers broad
authority on the Secretary of Health and Human Services ``to make
grants to and enter into contracts with public or nonprofit private
entities to assist in the establishment and operation of voluntary
family planning projects which shall offer a broad range of acceptable
and effective family planning methods and services (including natural
family planning methods, infertility services, and services for
adolescents).'' 42 U.S.C. 300(a). Congress placed specific limitations
on what constitutes appropriate ``family planning'' for purposes of
Title X. In Section 1008, Congress expressly required that ``[n]one of
the funds appropriated under this title shall be used in programs where
abortion is a method of family planning.'' 42 U.S.C. 300a-6. Congress
did not fully define ``family planning'' in the Title X statute.
However, section 1006 authorizes the Secretary to promulgate
regulations governing grants and contracts in the program. 42 U.S.C.
300(a). Accordingly, the Department has statutory authority to define
``family planning'' for the purposes of the Title X program.
Given the statutory emphasis on family planning, the Department
believes defining the phrase is important to ensure a coherent and
reliable implementation of Title X, consistent with carefully
considered statutory parameters. The Department disagrees with
commenters who contend there is little support for creating the
definition for family planning because no violations have been
identified. The Department does not have to identify violations in
order to interpret a statutory term. The Department deems it useful to
develop and maintain a definition of family planning, in order to
establish the scope of the Title X family planning program, to ensure
consistency across the program, and to meaningfully ensure that the
family planning projects implemented under Title X grants and/or
contracts provide a broad range of family planning methods and
services, consistent with the Title X statute. The Department believes
it is appropriate to exercise its rulemaking authority to define family
planning as a term important to the scope of the Title X projects, the
development of grant applications, and the issuance of grants and
contracts in the Title X program.
Moreover, the Department notes that the definition will address in
part its concern that the requirement for abortion referrals, as
provided in the 2000 regulations, violates or leads to violations of
section 1008's prohibition on funding Title X projects where abortion
is a method of family planning. Concerns about family planning methods
being used indirectly to violate requirements of the program dates back
at least to the 1988 regulations. There, the Department stated, in
Sec. 59.14, that a ``Title X project may not use prenatal, social
service or, emergency medical or other referrals as an indirect means
of encouraging or promoting abortion as a method of family planning . .
.'' 53 FR at 2945. This provision was upheld by the Supreme Court.\43\
That the 2000 regulations required certain abortion referrals, in a way
the Department, both previously and now, deems inconsistent with the
Title X statute, is itself a cause of confusion about what should and
should not be included as ``family planning'' under the Title X
program, and justifies the Department's decision to establish a
definition of family planning in this rule.
---------------------------------------------------------------------------
\43\ Rust v. Sullivan, 500 U.S. at 192-195.
---------------------------------------------------------------------------
The Department disagrees with the many commenters that oppose
defining ``family planning'' to exclude abortion and that urge the
Department to define the term to include abortion. Such commenters
appear to be either unaware of, or confused about (or to have
intentionally ignored), the fact that Title X explicitly excludes \44\
funding for projects where abortion is a method of family planning. The
Department is statutorily required to exclude abortion as a method of
family planning for purposes of the Title X program, see 42 U.S.C.
300a-6, and has no statutory authority to consider family planning
under Title X to include abortion. The
[[Page 7730]]
fact that so many commenters are unaware of or confused about this
requirement, and ask the Department to include abortion as a method of
family planning in violation of the Title X statute, reinforces the
Department's view that it is appropriate to define ``family planning''
to clarify the scope of the Title X family planning program, as well as
to establish other requirements that separate the Title X family
planning program and Title X family planning projects from abortion as
a method of family planning.
---------------------------------------------------------------------------
\44\ See 42 U.S.C. 300a-6.
---------------------------------------------------------------------------
Some commenters ask how the definition applies to abortions that
are not used as a method of family planning. Section 1008 prohibits
funding Title X projects where abortion is a method of family planning,
but does not preclude referral for services to address health issues or
conditions where treatment constitutes a medical necessity. In
addition, annual Title X appropriations law has consistently barred the
expenditure of Title X funds for abortion. See HHS Appropriations Act
2019, Public Law 115-245, Div. B, 132 Stat. 2981, 3070 (funds provided
to Title X projects ``shall not be expended for abortion'');
Consolidated Appropriations Act 2018, Public Law 115-141, Div. H, Title
II, 132 Stat. 348, 716 (same); Consolidated Appropriations Act 2017,
Public Law 115-31, Div. H, Title II, 131 Stat. 135, 521 (same);
Consolidated Appropriations Act 2016, Public Law 114-113, Div. H, Title
II, 129 Stat. 2242, 2602 (same). Title X primarily focuses on the
provision of certain preconception health care services. Nevertheless,
because of certain specific statutory provisions, the Department
believes that Title X providers can provide certain counseling and
referrals in a postconception setting, if compliance with the Title X
statutory and regulatory restrictions concerning abortion is
maintained. The Department has interpreted Title X to allow
nondirective postconception pregnancy counseling because of an express
annual appropriations rider on nondirective pregnancy counseling may be
offered. In addition, under the Infant Adoption Awareness grants
program, Congress specified that eligible health centers (which
includes Title X clinics) should receive training on providing adoption
information and referrals, and that the Secretary should encourage the
same,\45\ therefore expressing its intent that postconception adoption
information and referrals be included as part of any nondirective
counseling in Title X projects. Thus, adoption counseling and referral
is appropriate under Title X, since Congress specified that Title X
clinics and providers were eligible health centers to whom adoption
related training should be offered.\46\ However, this provision differs
from the actual provision of adoption services to an interested family,
which is outside of Title X health care services. In addition, Title X
funds may not be spent on childbirth services or prenatal care, but
referrals for prenatal care can be required because it is medically
necessary for pregnancy and provides information rather than services.
---------------------------------------------------------------------------
\45\ See 42 U.S.C. 254c-6 (Congress authorized the Department to
make grants ``for the purpose of developing and implementing
programs to train the designated staff of eligible health centers in
providing adoption information and referrals to pregnant women on an
equal basis with all other courses of action included in
nondirective counseling to pregnant women.'').
\46\ Finalizing the definition of family planning to include
adoption information and referrals is also part of the Department's
fulfillment of its duties under section 330F, should grants under
that section be funded.
---------------------------------------------------------------------------
Taking those provisions, the annual appropriations provision, and
section 1008 together, the Department has concluded that Title X
projects may allow a physician or APP to provide nondirective
counseling on abortion generally as a part of nondirective pregnancy
counseling, and may refer for abortion for documented emergency care
reasons, but may not refer for abortion as a method of family planning.
Similarly, the nondirective pregnancy counseling can include counseling
on adoption, and corresponding referrals to adoption agencies. As a
consequence, the Department considers it appropriate to define ``family
planning'' as (1) excluding abortion, (2) permitting the provision of
nondirective pregnancy counseling (including abortion and adoption),
and (3) including and requiring Title X projects to refer for prenatal
care services.
The Department disagrees with commenters who oppose the last
sentence of the definition because, in the commenters' view, Congress's
intent in Title X did not include the reduction of abortion.\47\ The
1988 regulations, which were upheld by the Supreme Court in Rust,
contained the same statement, that ``[f]amily planning, as supported
under this subpart, should reduce the incidence of abortion.'' See
Rust, 500 U.S. at 193. The Court stated, ``Here the Government is
exercising the authority it possesses under Maher and Harris v. McRae,
448 U.S. 297 (1980), to subsidize family planning services which will
lead to conception and childbirth, and declining to `promote or
encourage abortion.' The Government can, without violating the
Constitution, selectively fund a program to encourage certain
activities it believes to be in the public interest, without at the
same time funding an alternative program which seeks to deal with the
problem in another way.'' Id. In choosing to fund family planning
methods, but declaring no Title X project can receive funding where
abortion is a method of family planning, Congress decided to encourage
certain activities as an alternative to funding abortion. The Court
explained such a decision neither infringes upon nor does it constitute
State interference in abortion; it represents a legitimate choice by
the government to encourage some activities over others. Id. Reducing
abortion is also commonly identified by the government, researchers,
private organizations, and many public commenters here, as being a
potential and significant benefit of family planning.\48\ The
Department, therefore, concludes it is appropriate to define one
purpose of family planning, under the Title X family planning program,
as being to reduce the incidence of abortion.
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\47\ The final sentence of the proposed definition of ``family
planning'' is that ``[f]amily planning, as supported under this
subpart, should reduce the incidence of abortion.''
\48\ See, e.g., Guttmacher Institute, New Clarity for the U.S.
Abortion Debate: A Steep Drop in Unintended Pregnancy Is Driving
Recent Abortion Declines, (March 18, 2016), https://www.guttmacher.org/gpr/2016/03/new-clarity-us-abortion-debate-steep-drop-unintended-pregnancy-driving-recent-abortion (stating that
``expanding women's access to family planning services not only
protects U.S. women's health and rights, it also reduces abortion
rates.'')
---------------------------------------------------------------------------
Defining family planning, for the purposes of Title X, to exclude
abortion, and as being, at least in part, for the purpose of reducing
abortion, does not suggest that Title X projects may engage in
directive pregnancy counseling to reduce abortion. As discussed below,
when a Title X physician or an APP engages in pregnancy counseling,
such counseling must be nondirective. But the fact that reducing
abortion is not a goal of pregnancy counseling under Title X does not
mean that the Department's provision and promotion of family planning
in all other contexts cannot be undertaken, in part, for the purpose of
reducing the incidence of abortion. When the Department funds Title X
projects that provide a broad range of family planning methods and
services to prevent pregnancy, the results will likely include, among
other things, a decrease in pregnancy and with it, a decrease in the
incidence of abortion as a method of family planning.
The Department disagrees with commenters who oppose the
[[Page 7731]]
definition's references to natural family planning, fertility
awareness-based methods, and choosing not to have sex (which some
commenters refer to as abstinence), or who say the definition
emphasizes those methods over contraception or other methods. The
definition of ``family planning'' does not emphasize or prioritize
those methods over contraception, but mentions them alongside
contraception and other family planning methods in a non-exhaustive
list of methods of family planning. To the extent many commenters
oppose including natural family planning and fertility awareness-based
methods in ``family planning'' at all, the commenters are arguing
against the Title X statute, not this rule. Title X specifies that the
Department fund projects ``which shall offer a broad range of
acceptable and effective family planning methods and services
(including natural family planning methods . . .).'' 42 U.S.C. 300(a).
Congress has, thus, dictated that, for the purposes of Title X, family
planning includes natural family planning methods. As a consequence,
the Department lacks the authority to exclude natural family planning--
or any other family planning method or service mentioned in the Title X
statute--from the definition of family planning in Title X. Since
Congress explicitly mentions it in Title X as part of family planning
services to be provided by a Title X project, the Department declines
to delete or deemphasize natural family planning.
The term ``fertility awareness-based methods'' is a more recent
term that refers to the same general kind of family planning methods
that Congress intended when it included ``natural family planning'' in
the Title X family planning program. The science of natural family
planning methods, and other family planning methods (including
contraceptives), has advanced significantly since Congress enacted
Title X in 1970. As explained further below, the term ``fertility
awareness-based methods'' includes similar family planning methods and
services captured by the term ``natural family planning'' in the
statute. But for greater clarity as to the scope of the program, the
Department finalizes the definition as proposed to mention fertility
awareness-based methods alongside natural family planning.
The Department agrees with commenters who support Congress's
inclusion of natural family planning methods in Title X. Some
commenters point out that very few women use natural family planning
methods within Title X, but there is insufficient information on why
this may be the case. It may be that the method is not presented by a
clinic as a meaningful option or it may be that staff are not
adequately trained in the method. In general, an increasing number of
persons are choosing natural family planning methods,\49\ at the same
time that the scientific basis and approvals for fertility awareness-
based methods are also increasing.\50\ Requiring projects to provide
natural family planning, in addition to contraceptives and other family
planning methods and services, does not mandate that such projects
provide them in the same quantity, but that natural family planning be
meaningfully included in the project.
---------------------------------------------------------------------------
\49\ The Guttmacher Institute reported that the percentage of
women using natural family planning doubled between 2008 and 2014.
Megan L. Kavanaugh and Jenna Jerman, Contraceptive method use in the
United States: trends and characteristics between 2008, 2012 and
2014, Guttmacher Institute, 97 Contraception 1:14-21 (Jan. 2018),
https://www.contraceptionjournal.org/article/S0010-7824(17)30478-X/
fulltext.
\50\ See e.g., FDA News Release, FDA allows marketing of first
direct-to-consumer app for contraceptive use to prevent pregnancy,
(Aug. 10, 2018), https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm616511.htm (permitting marketing of a
fertility-awareness-based mobile medical application).
---------------------------------------------------------------------------
In response to this and other sections of the proposed rule, some
commenters contend natural family planning or fertility awareness-based
methods should be excluded from Title X projects because they are not
effective. The Department does not find the exclusion of such methods
to be consistent with the direction of Congress in section 1001(a),
which explicitly includes natural family planning in the range of
family planning methods provided through Title X. The commenters also
provide no evidence to conclude that natural family planning is
categorically ineffective, even if such a conclusion could overcome the
statutory language including natural family planning as among the
methods of family planning that may be offered in a Title X project.
These commenters do not acknowledge that, in the last 40 years, the
science behind, and efficacy of, fertility awareness-based methods has
improved significantly, leading to FDA approval of certain medical
products involving such methods and to increased utilization of these
methods.\51\ The Department also does not find it consistent with the
principle of patient choice categorically to deprive individuals or
families of the option of obtaining natural family planning or
fertility awareness-based family planning methods within Title X
projects.
---------------------------------------------------------------------------
\51\ See, e.g., Shawn Malarcher, et. al., Fertility Awareness
Methods: Distinctive Modern Contraceptives, 4 Global Health: Science
and Practice 13, 13 (2016), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4807745/pdf/013.pdf (stating
fertility awareness methods of contraception have been tested and
proven effective at pregnancy prevention and safe to use).
---------------------------------------------------------------------------
The Department similarly disagrees with commenters who oppose
including choosing not to have sex as a method of family planning.
Choosing not to have sex, either for a long period of time or for
selected intervals, or choosing not to have sex as often or with as
many sexual partners, is clearly a preconception method of family
planning for reducing unintended pregnancy. In addition, choosing not
to have sex or engaging in sex with a single monogamous partner is
protective of preconception health, particularly because it protects an
individual from exposure to STDs that may contribute to infertility and
negative health outcomes. As a viable method for delaying or avoiding
pregnancy altogether, the Department would be remiss if it were to
exclude this method, since consistently choosing not to have sex is the
most effective way to prevent pregnancy. As with natural family
planning, the inclusion of this method within the definition of
``family planning'' does not invalidate other methods within that
definition, nor mean that every Title X clinic has to provide
counseling services related to this method of family planning.
The Department therefore disagrees with commenters who contend that
recognizing these options within the definition of family planning will
diminish an individual's ability to choose another form of family
planning. Projects must also provide contraception, and can do so in
proportion to the demand for such methods. The individual's free and
informed choice to select a family planning method is respected by
requiring projects to provide the broad range of family planning
options that Congress contemplated in the statute, and to allow
individuals to freely select the method they prefer. The definition of
family planning merely specifies that these methods are included in the
broad range of family planning methods available within each Title X
project. Projects may comply with the statutory directive when they
include natural family planning in the broad range of family planning
methods and services that must be provided. The definition also
specifies that family planning is never to be coercive and must always
be strictly voluntary. This precludes the conclusion, put forth by some
commenters, that including natural family planning or choosing not to
have
[[Page 7732]]
sex in the definition imposes a requirement on any clients.
The Department also notes that this final rule is consistent with
the proposed rule, which explicitly includes contraception in the
definition of family planning. Contrary to the suggestion of some
commenters, the definition does not place a lower priority on
contraception as a method of family planning, nor somehow invite Title
X providers to pressure clients to use natural family planning instead
of contraception. The rule, both as proposed and finalized, will allow
funded projects to provide all acceptable and effective Title X family
planning methods, while ensuring that participating entities or service
sites that wish to offer only a single method or a limited number of
methods may also participate in Title X projects, so long as each Title
X project, as a whole, provides a broad range of family planning
methods and services, including contraception and natural family
planning.
Clarifying that those options fall within the program is well
within the purview of the Title X program, and ensures individuals'
voluntary and informed access to the family planning option of their
choice. The Department does not agree that the definition blurs lines
between different family planning options, methods, or choices. Rather,
the Department agrees with comments suggesting that the new definition
of family planning will expand access to a broad range of family
planning methods and services and will ensure patients have the ability
to make voluntary and informed family planning choices. To provide
clarity and ensure that duplicative terms are not interpreted with
different meanings, the Department revises the definition by using the
words used in the Title X statute, ``methods and services,'' instead of
the word ``choices'' that was used in the proposed rule. The Department
further modifies the sentence ``Family planning and family planning
services are never coercive and are strictly voluntary'' to read
``Family planning methods and services are never to be coercive and
must always be strictly voluntary.'' This clarifies the terms in the
sentence and also further aligns the definition with the voluntary
requirements set forth in sections 1001 and 1007 of Title X.
The Department acknowledges the concerns of commenters who contend
the proposed definition would leave women without access to
contraception or other methods of family planning, but believes that
these concerns are overstated. The Department is aware of reported
success rates regarding various forms of preconception family planning
for those engaged in sexual activity. The Department wishes to
emphasize that, consistent with the statutory provisions, contraception
will continue to be a significant category of family planning methods
for Title X projects. This is why the family planning definition
specifically mentions contraception among other family planning methods
and services and why Sec. 59.5 continues to require a broad range of
acceptable and effective family planning methods and services within
Title X projects. The Department does not intend to implement or
enforce these regulations to have any limiting effect on Title X
organizations that offer contraception options if those organizations
are otherwise compliant with the Title X grant requirements. The
Department believes that the proposed rule broadens access for women
seeking preconception family planning options by permitting grantees or
subrecipients to provide various or specialized forms of family
planning, while also ensuring that projects, as a whole, provide a
broad range of family planning methods and services.
The Department finds there is insufficient evidence to support the
contention of some commenters that negative impacts will result from
the definition, such as driving out some providers, increasing
unintended pregnancy, or increasing STDs. The definition encompasses
contraception and other methods that these commenters support, and it
will not deprive Title X projects of the ability to offer any such
methods or services. To the extent commenters believe these negative
results will occur because the definition of family planning excludes
abortion, and includes natural family planning, both parameters have
been mandated by the Title X statute for decades. Any such effect,
then, would be attributable to implementing the program as Congress
directed.
The Department disagrees with commenters who ask that the
definition specify that all family planning methods and services must
be ``medically approved.'' The Department also discusses this issue
below concerning the change in such language at Sec. 59.5. When
Congress specified what family planning methods and services Title X
projects must provide, Congress directed that the methods and services
be ``acceptable and effective''; it did not specify that they be
``medically approved.'' The Department also does not understand, and
commenters fail to explain, what the addition of ``medically approved''
to the definition would mean in practice. Family planning methods and
services are often provided through licensed health care professionals.
Thus, it is true of all family planning methods or services provided by
Title X providers that at least one medical professional or clinic has
``approved'' the method or service, by virtue of providing it to the
client. It is not clear what else a requirement of medical approval
might mean, or what commenters believe it to mean, if inserted into the
family planning definition. For example, would approval by one medical
doctor suffice, or would some larger number need to approve, and if so,
how many; would certain medical organizations, or governmental
organizations, or both, need to approve, and if so, which ones; would a
certain level of medical consensus need to exist concerning a
particular method or service, and if so, how would the Department
measure that consensus; and when doctors and medical organizations
disagree either about a family planning method or service, how would
that requirement apply? For all of these reasons, the Department does
not believe the Title X statute requires the term ``medically
approved'' be included in this definition, and does not believe
including it is appropriate. The Department instead relies on the
statutory language ``acceptable and effective'' as sufficiently
ensuring that family planning methods and services are appropriate for
clients served in Title X projects.
The Department disagrees with commenters who contend the definition
of family planning violates the religion clauses of the First
Amendment. As discussed in Rust, the Supreme Court has stated many
times that the Constitution does not require the government to fund
abortion, and it allows the government to encourage alternatives to
abortion. See Rust, 500 U.S. at 201. The inclusion of natural family
planning in the definition of ``family planning'' is a congressional
mandate and has existed for decades--there is no legitimate legal
reason to believe it violates the First Amendment.
In response to commenters asking whether family planning includes
sterilization, the Department clarifies that acceptable and effective
methods of sterilization are a preconception means of implementing an
individual's or family's decision as to the number and spacing of
births.
The Department agrees with commenters that support the limitation
in the proposed definition that family planning does not include
postconception health care (as distinct from certain types of
postconception counseling/information, such as in the
[[Page 7733]]
case of congressionally permitted nondirective pregnancy counseling),
but does include preconception counseling, education, and health care
that can improve maternal and infant outcomes; the health of women,
men, and adolescents who seek family planning services; and the
prevention, diagnosis, and treatment of infections and diseases that
may threaten childbearing capability or the health of the individual,
sexual partners, and potential future children. This is consistent with
the legislative history of the Title X program, which emphasizes
Congress's intent for the program to focus on preconception health
services as important to family planning.\52\ This Congressional intent
is another basis for excluding abortion as a method of family planning
from the definition of family planning for the purposes of Title X,
because abortion is a postconception service. As discussed further
below, Title X projects are not required to provide abortion
information or counseling, and if nondirective pregnancy counseling is
offered, any abortion counseling also must be nondirective.
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\52\ See H.R. Rep. No 91-1667, at 8-9 (1970) (Conf. Rep.)
(emphasizing the intent of Congress that Title X funds specifically
support preconception family planning, stating ``[i]t is, and has
been, the intent of both Houses that funds authorized under this
legislation be used only to support preventive family planning
services, population research, infertility services and other
related medical, information, and educational activities. The
conferees have adopted the language contained in section 1008, which
prohibits the use of such funds for abortion, in order to make clear
this intent.'').
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The Department finds that a distinction between preconception
health care services and postconception services is effective and can
be more cost-effective. The Department disagrees with commenters who
contend limiting family planning to preconception care is contrary to
national standards. For the purposes of the Title X program, the
limitation to preconception care is appropriate and consistent with
Congressional intent. Any concern with national standards is met and
addressed by encouraging Title X projects to offer either comprehensive
primary health care services onsite or have a robust referral linkage
with primary health care providers who are in close proximity to the
Title X site. The Department will administer Title X funds to focus on
permissible preventive care and preconception family planning, while
promoting robust referral networks to ensure that clients have ready
access to non-Title X health care services that they need, including
treatment for health conditions that are not provided by Title X and
for postconception care (other than abortion as a method of family
planning).
The Department appreciates and responds to comments raising concern
about the inclusion of adoption in family planning services and
clarifies the purpose of the rule in this regard, finalizing a change
to the language concerning adoption. Adoption is a method by which
families can plan their family size, to either increase it, decrease
it, relieve burdens attendant to insufficiently spaced children, or
deal with infertility (although infertility management is not the only
way in which adoption is a method of family planning, and adoption is
not the only method of infertility management). Insofar as adoption is
considered a preconception method by which families may plan their
family size or respond to infertility, it fits comfortably within the
broad range of family methods and services contemplated by Title X.
Although many commenters focus on the important role of Title X
providers in preventing unintended pregnancy through contraception or
not having sex, Congress clearly intended Title X to support family
planning through more than preventive services, as evidenced by the
emphasis on infertility services in Title X. See 42 U.S.C. 300(a)
(Title X family planning projects required to ``offer a broad range of
acceptable and effective family planning methods and services
(including natural family planning, infertility services, and services
for adolescents)'').\53\ The Department thus found and continues to
find that Title X is an important resource for individuals seeking
assistance to have children, and adoption is one method by which a
Title X client who is not pregnant may seek to have children.\54\
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\53\ See 53 FR at 2922 (the Department historically found ``it
is clear that Congress intended the term ``family planning'' to be
broader in scope than simply contraception, as infertility services
are included as one of the mandatory services listed in section
1001(a) of the Act.'').
\54\ Id. This interpretation is consistent with the Department's
history of enforcing Title X regulations regarding adoption: ``Both
approaches [adoption and infertility services] constitute legitimate
means of determining family size and spacing, but adoption is simply
one means of addressing the broader problem of infertility.'' Id.
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Moreover, Congress has expressed its intent that postconception
adoption information and referrals be included as part of any
nondirective counseling in Title X projects when it passed the
Children's Health Act of 2000, adding section 330F (``Grants Regarding
Infant Adoption Awareness'') to the Public Health Service Act on
October 17, 2000. Public Law 106-310, 114 Stat. 1101, sec. 1201,
codified at 42 U.S.C. 254c-6 (hereinafter ``Infant Adoption Awareness
grants''). There, Congress authorized the Department to make grants
``for the purpose of developing and implementing programs to train the
designated staff of eligible health centers in providing adoption
information and referrals to pregnant women on an equal basis with all
other courses of action included in nondirective counseling to pregnant
women.'' 42 U.S.C. 254c-6(a)(1). Congress specified that grantees shall
offer that training to Title X grantees and the Secretary shall make
reasonable efforts to encourage Title X grantees to participate in that
training.\55\ At least some major organizations ``understood the
legislation and the guidelines for the Program to strongly suggest that
those working in clinics receiving funds through Title X family
planning grants . . . be the principal target for the training.'' \56\
If the provision to pregnant women, of nondirective adoption counseling
and referral were not appropriate under Title X, Congress would not
have specified that Title X clinics and providers were eligible health
centers to whom such adoption related training should be offered. This
interpretation has been carried into current practice by major adoption
organizations, such as The National Council for Adoption.\57\
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\55\ See 42 U.S.C. 254c-6(a)(5) & (6)(A) (adoption organization
required to make reasonable efforts to ensure that training is
provided to, among others, ``eligible health centers that receive
grants under section 1001 (relating to voluntary family planning)'';
with respect to eligible health centers that received grants under
section 330 or 1001, ``[t]he Secretary shall make reasonable efforts
to encourage eligible health centers to arrange for designated staff
to participate in such training. Such efforts shall affirm Federal
requirements, if any, that the eligible health center provide
nondirective counseling to pregnant women.'').
\56\ See The National Council For Adoption, NCFA's Infant
Adoption Awareness Training Program--A Successful Model, 193.
\57\ Finalizing the definition of family planning to include
adoption information and referrals is also part of the Department's
fulfillment of its duties under section 330F, should grants under
that section be funded.
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By contrast, because of Congress's primary focus on funding
preconception care in Title X, the Department deems the provision of
adoption services themselves to be outside the scope of the Title X
program. This clarification should address the concern by some
commenters about a potential strain on resources of the Title X program
caused by the inclusion of adoption in the family planning definition.
Title X providers may provide adoption counseling, information, and
referral as a voluntary family planning service for non-pregnant
clients as a means of addressing health care issues related to
[[Page 7734]]
fertility and reproduction, such as infertility, and as part of
nondirective postconception counseling, but may not provide adoption
services themselves within the project.
This approach is consistent with the Title X parameters and with
the Department's history of implementing Title X. In the 1981 Title X
program guidelines, ``Program Guidelines for Project Grants for Family
Planning Services,'' the Department allowed nondirective counseling on,
and referral for, adoption and foster care when a woman with an
unintended pregnancy requested information on her options. The 1988
regulations continued this support for encouragement of counseling on
and referral for adoption. The 2000 regulations required both
counseling and referral on adoption, if the client requested such
assistance. Given this history and Congress's expressed intent, the
Department concludes that Title X funds may facilitate access to
adoption through nondirective adoption counseling and referral as a
part of the nondirective counseling offered to pregnant clients.
Congress's express intent to include adoption information and
referral in Title X projects can be contrasted with its express intent
to exclude Title X funding from any projects where abortion is a method
of family planning. The Title X statute contains no similar prohibition
on funding projects where adoption is a method of family planning, and
section 330F requires the Secretary to encourage the inclusion of
adoption information and referrals in the Title X program. Similarly,
the Title X statute contains no similar prohibition on funding projects
that include postconception referrals for prenatal care, which is
necessary for pregnancy as a medical condition. Thus, the Department
disagrees with commenters contending that the definition improperly
discriminates by treating adoption more favorably than abortion. Simply
put, abortion is prohibited as a method of family planning within a
Title X project and adoption is not. Given Congress's explicit
differential treatment of adoption and abortion throughout the
applicable statutes, the definition is an appropriate exercise of the
Department's authority to promulgate regulations to implement the Title
X family planning program.
For all these reasons, the definition of family planning
appropriately includes adoption information and referral as a family
planning method. To clarify this, in response to questions from
commenters about this issue, the Department modifies this aspect of the
family planning definition in the final rule by changing ``the
management of infertility (including adoption)'' to ``the management of
infertility, including information about or referrals for adoption.''
3. Definition of Grantee
Summary of changes: The 2000 regulations did not define a
``grantee'' under Title X. The proposed rule, at Sec. 59.2, proposed
to define ``grantee'' as ``the entity that receives Federal financial
assistance by means of a grant, and assumes legal and financial
responsibility and accountability for the awarded funds, for the
performance of the activities approved for funding and for reporting
required information to the Office of Population Affairs.''
There were no substantive comments regarding this definition.
The Department finalizes the definition of ``grantee'' in Sec.
59.2 without change, except for minor grammatical corrections.
4. Definition of Low Income Family
Summary of changes: The 2000 regulations at Sec. 59.2 defined
``low income family'' by income and allowed the project director to
determine ``good reasons'' where an individual may qualify even if
income exceeded the defined amount. Pursuant to an example in the
definition, minors who wish to receive services on a confidential basis
are considered on the basis of their own resources. The proposed rule,
at Sec. 59.2, proposed to modify the existing definition of ``low
income family'' relating to minors by requiring the program to document
its efforts to encourage the unemancipated minor to involve his/her
family in the decision to seek family planning services, in order to
ensure compliance with the applicable Title X and appropriations law
provisions on the issue. In addition, the proposed rule included a
provision whereby the project director may consider a woman as a low
income family when her employer-sponsored health insurance does not
cover certain contraceptives because of her employer's religious or
moral objection to such contraceptives. The Department recognizes that
a woman's insurance coverage may relate to her ability to pay for
family planning services. The Department finalizes the proposed
modifications with no substantive changes to the definition with
respect to unemancipated minors, but with some minor grammatical
corrections. However, in response to public comments, the Department
also finalizes paragraph (2) under the definition for low-income family
for cases involving ``payment for contraceptive services only,'' where
the woman's employer ``does not provide the contraceptive services
sought by the woman because the employer has a sincerely held religious
or moral objection to providing such coverage.'' This final rule
clarifies that, in these cases, the project director may exercise
discretion under the existing ``good reason'' exception to ``consider
her insurance coverage status as a good reason why she is unable to pay
for contraceptive services.'' In making this determination, the project
director ``must also consider other circumstances affecting her ability
to pay.'' This final rule then provides mechanisms by which a director
may determine whether the woman is from a ``low income family'' or is
eligible for a discount for contraceptive services on the schedule of
discounts provided for in Sec. 59.5.''
Comments: Some commenters support the proposed changes to the
definition of low income family. Some of these commenters support the
encouragement of family participation in the family planning decisions
of minors. Some also support the definition's clarification about how
women may be eligible to receive contraceptive services where health
insurance from their employers does not cover those services due to
their employers' religious or moral objections. Some commenters support
the change because they say it assists the Department in not requiring
employers to violate their religious or moral beliefs, while protecting
the ability of women to receive family planning services.
Commenters support the encouragement of family participation in the
family planning decisions of minors, noting that it does not block
access to family planning services. Rather, as comments explain, family
participation should be the standard for any health care service
provided to minors because they do not always know their family history
and certain contraceptives are contraindicated for females with certain
health conditions. In addition, parents are better able to direct
health care decisions for their children if they are aware of other
health care services and products that their children are receiving.
Some commenters oppose the definition's requirement that
emancipated minors be charged based on their own income only if there
is documentation of specific actions taken with respect to each minor
to encourage such family participation. Such commenters are concerned
this would threaten the confidentiality of these patients, as well as
the patient-provider
[[Page 7735]]
relationship. Commenters state that providers typically use their
expertise and judgment when deciding whether or not to encourage family
involvement in the care of patients who are minors, and they identify
situations in which family involvement should not be encouraged, such
as in cases of neglect, coercion, or abuse. Some commenters are worried
that the definition could cause strain on the patient-provider
relationship and could lead to patients omitting information that would
impact their care. Other commenters are concerned the definition would
increase barriers for minors receiving low cost or free, confidential
care. Such commenters conclude the revision runs counter to
congressional intent, by including services for adolescents in the
Title X statute, and exceeds the Department's authority under Title X.
One commenter asks the Department to include additional language in the
rule to ensure confidentiality for such minors; confidentiality of the
information received about minors' circumstances; that the
encouragement of family involvement is not coercive; and, that the
minor's decision to involve his or her family is strictly voluntary.
Many commenters also oppose revising the definition of low income
family to include women who are unable to obtain certain family
planning services under their employer-sponsored health insurance
policies due to their employer's sincerely held religious or moral
objections. Many such commenters assert that Title X is already
underfunded, and this revision would result in a large number of new
Title X patients and could reduce services for actual low income
patients, due to limited funds. Many stated that, if the Department
does revise the definition, there must be increased Title X funding to
account for the new patients.
Commenters who are health care providers note that the Department
did not discuss the impacts this change would have on Title X patients
and providers. Such commenters stated that the proposed rule did not
provide evidence to support the conclusion that the Title X network can
absorb the new patient population, nor address how the change would
impact current patients. They also contend that the proposed rule did
not discuss any financial impacts, operational impacts on projects, or
corresponding costs. For example, commenters contend the Department did
not explain how women are to show they are in an employer plan with a
religious or moral objection to contraceptive coverage. Some Title X
providers comment that requiring projects to verify that status would
be cumbersome and involve administrative costs. Some commenters ask
whether newly eligible patients would be able to obtain other services
(e.g., STD testing or Pap test) during a contraceptive visit and
whether these services would also be free, and request guidance on that
question.
Many commenters object to the new definition on the ground that
previous interim final rules concerning contraceptives issued by the
Department and the Departments of Labor and of the Treasury in October
2017 are not in effect based on court orders. Such commenters also
contend the definition applies to women who are the policyholders of
employer-sponsored insurance but not to other beneficiaries of such
plans. Commenters further object that the definition does not guarantee
coverage for such women but only states the project director may
consider her as being from a low income family if good reasons exist
under the definition. And commenters object that some women with
insurance sponsored by an employer that objects to contraceptive
coverage for religious or moral reasons might not have access to a
Title X provider.
Some commenters assert that the Secretary does not have the legal
authority to deem women as ``low income'' if their employer-sponsored
plans have religious or moral objections to contraceptive coverage.
Some commenters object that the definition only encompasses women, not
men, whose employer-sponsored plans have religious or moral objections
to contraceptive coverage, and they believe the definition does not
encompass transgender men. One commenter contends the definition
constitutes impermissible government subsidy of religious objections
under the Establishment Clause of the First Amendment.
Response: The Department agrees with commenters generally
supporting the revised definition concerning minors and women with
employer-sponsored health insurance that does not cover contraceptive
services based on the employer's religious or moral objections.
Nevertheless, the Department has carefully considered all the comments,
including comments opposing the changes, and is finalizing the
definition with changes in response to those comments.
The Department disagrees with the suggestion of some commenters
that its revised definition of low income family threatens the
confidentiality of unemancipated minors. The revised definition
explains that, if a project director seeks to consider only an
unemancipated minor's own resources to determine whether the minor
seeking confidential services qualifies as a low income family, the
project director must document efforts to encourage family
participation in the unemancipated minor's decision to seek family
planning services. As discussed more fully below, such encouragement is
specifically required by Congress and would occur within the context of
the provider-patient relationship. Communications in that relationship
are already confidential, and communications in which the provider
encourages family participation in the minor's decision to seek family
planning services would be subject to the same confidentiality
requirements.
The Department similarly disagrees with the suggestion that this
documentation requirement infringes on the judgment of medical
professionals or threatens minors who are in abusive home
circumstances. As discussed below, this final rule does not require a
Title X provider to encourage family involvement ``if the Title X
provider has documented in the medical record: (i) That it suspects the
minor to be the victim of child abuse or incest; and (ii) That it has,
consistent with, and if permitted or required by, applicable State or
local law, reported the situation to the relevant authorities.''
Situations exist where confidentiality is important, and the Department
incorporated those into the proposed rule. Moreover, the rule does not
require family participation, but merely the encouragement of such
participation. Inserting references to that general requirement in the
definition of ``low income family'' concerning unemancipated minors
simply reinforces the already existing statutory requirement--and
ensures that Title X providers are actually complying with such
requirements. To the extent that there were any infringement on the
judgment of medical professionals, it would be the result of
requirements imposed on the Title X program by Congress, requirements
that the Department merely seeks to faithfully implement.\58\
---------------------------------------------------------------------------
\58\ For additional responses to similar comments, please see
the discussion of Sec. 59.17, in which the Department responds more
fully to similar objections.
---------------------------------------------------------------------------
Some commenters contend the Department lacks statutory authority to
include as ``low income'' patients women who have employer-sponsored
health insurance that does not cover contraceptive services based on
the employer's religious or moral
[[Page 7736]]
objections, but this argument appears to be premised on a
misunderstanding of the Department's proposal. Section 1006 gives the
Secretary of HHS the authority to promulgate regulations governing
grants and contracts issued under the Title X statute. 42 U.S.C. 300a-
4. Section 1006 further specifies that projects receiving Title X
grants or contracts must assure the Department that ``priority will be
given in such project or program to the furnishing of such services to
persons from low income families'' and that ``no charge will be made in
such project or program for services provided to any person from a low
income family except to the extent that payment will be made by a third
party (including a government agency) which is authorized or is under
legal obligation to pay such charge.'' 42 U.S.C. 300a-4(c)(2). Section
1006 does not define ``low income family,'' but instead declares that
the Secretary has discretion to define ``the term `low income family'.
. . in accordance with such criteria as he may prescribe so as to
insure that economic status shall not be a deterrent to participation
in the programs. . . .'' 42 U.S.C. 300a-4(c). Consequently, Congress
granted the Secretary discretion to decide what constitutes a ``low
income family'' for the purpose of giving priority of services to
persons from such families, so as to ensure that economic status is not
a deterrent to participating in Title X programs. Id.
For decades, the Department has implemented such regulations by
defining ``low income family'' to mean a family whose total income does
not exceed 100% of the Poverty Level guidelines,\59\ along with
individuals in families whose income does exceed that level but for
whom the project director determines--based on unenumerated factors--
that there are ``good reasons'' to conclude is ``unable'' to pay for
family planning services. 42 CFR 59.2. The 2000 regulations provide the
example of unemancipated minors who desire to receive services on a
confidential basis. 42 CFR 59.2. The proposed addition to the
definition maintains the same standard and simply specifies that one
factor relevant to the ``good reasons'' standard is a woman's insurance
status -which may affect her financial/economic status--with respect to
the provision of contraception because of her employer's religious or
moral objection to contraceptive coverage. Project directors already
have this discretion under the 2000 regulations. The text of the
proposed rule simply makes it explicit that a project director may rely
on this factor in such circumstances. Some commenters are under the
mistaken impression that the proposed rule requires project directors
to consider women as being from a low income family if they have this
insurance status, but the proposed rule said the project director
``may'' reach that conclusion, not that the director ``must'' do so.
---------------------------------------------------------------------------
\59\ See 42 U.S.C. 9902(2).
---------------------------------------------------------------------------
This clarification does not, as some commenters contend, contradict
the text or intent of the Title X statute. Congress authorized the
Secretary to decide what constitutes a ``low income family'' in the
program, and the Department's decades-old decision has allowed project
directors to deem families ``low income'' even if their income exceeds
100% of the Poverty Guidelines. Thus, project directors might conclude
based on a particular prospective client's insurance, income, and
financial situation that the individual is unable to pay for family
planning services. The proposed definition clarifies that a project
director may--but is not required to--allow the same treatment for
women with health insurance from an employer with a religious or moral
objection to contraceptive coverage. And the definition instructs the
project director to consider the woman's income in assessing her
ability to pay. Thus, under the definition, if a project director
concludes that a woman with that insurance status who has an income
above 100% of the Poverty Guidelines \60\ can afford to pay for family
planning, the project director should conclude that she is not from a
low income family. But the project director is also free to conclude,
taking into account the particular circumstances, that a woman with
that insurance status who has an income above 100% of the Poverty
Guidelines cannot, in fact, afford to pay for family planning and
should qualify as ``low income.'' That flexibility makes sense, as a
woman's ability to obtain contraceptive services through an insurance
plan may be relevant to her ability to pay for family planning
services, and Congress has long directed that ``low income family'' be
defined ``so as to insure that economic status shall not be a deterrent
to participation in the programs assisted under this title.'' 42 U.S.C.
300a-4(c).
---------------------------------------------------------------------------
\60\ The poverty guidelines updated periodically in the Federal
Register by the U.S. Department of Health and Human Services under
the authority of 42 U.S.C. 9902(2). See Office of the Assistant
Secretary for Planning and Evaluation, U.S. Federal Poverty
Guidelines Used to Determine Financial Eligibility for Certain
Federal Programs (Nov. 15, 2018, 9:51 a.m.), https://aspe.hhs.gov/poverty-guidelines.
---------------------------------------------------------------------------
Some commenters correctly read the proposed definition to mean the
project director may, or may not, deem a particular woman who lacks
insurance coverage for contraception because of her employer's
religious or moral objection as being from a ``low income family,'' and
they object to the Department giving the director that discretion. They
seem to ask that the Department require the project director to deem
such women as being from a ``low income family,'' \61\ regardless of
her family's total annual income, or other factors contributing to her
ability to pay for family planning.
---------------------------------------------------------------------------
\61\ See 42 U.S.C. 300a-4.
---------------------------------------------------------------------------
The Department rejects that suggestion. It is true that the
Department has required, in the ``low income family'' definition, that
a project director ``must'' consider only an unemancipated minor's own
resources if the minor seeks confidential services to determine whether
the minor is from a ``low income family.'' In that way, the Department
has previously exercised its regulatory authority to define ``low
income family'' to include some persons who potentially have ability to
pay for family planning--namely, minors from families who may have
access to funds to pay for family planning services even if they are
not employed. But in this case, the Department declines to finalize the
definition to require project directors to consider a woman as being
from a ``low income family'' based solely on her employer's religious
or moral objection to contraceptive coverage. Some women in such
circumstances may be unable to pay for family planning, but others may
be able to pay. For example, some may be from families with total
incomes well above the poverty level, and their other circumstances may
reflect that they are able to pay. The Department wishes to leave this
discretion with the project director.
The Department disagrees with commenters who contend the definition
is confusing and leaves project directors with insufficient guidance.
For decades, the definition of ``low income family'' has given project
directors discretion to determine whether good reasons exist as to why
a person cannot pay for family planning. The definition being finalized
here provides more guidance, not less, for the project director's
exercise of that discretion in the given scenario.
Some commenters object that projects will not be able to determine
whether a woman's employer-sponsored insurance omits contraceptive
coverage, or does so on the basis of religious or moral objections, but
the Department believes
[[Page 7737]]
this concern is overstated. This task is not fundamentally different
from the task that projects face in determining what a person's income
is, or whether, despite their income being above the poverty level,
good reasons exist for considering them unable to pay for family
planning. Guidance has set forth a variety of ways to seek information
of this kind, including that set forth in the 2014 Title X program
requirements.\62\ Projects are also generally required to obtain third
party payment or contribution for services that persons receive for
free or at a sliding scale discount. All of these types of information
are similar to the types of information that might demonstrate to a
project that a woman has employer-sponsored health insurance that does
not provide certain contraceptive coverage because the employer has a
religious or moral objection to providing such coverage. A pay stub may
demonstrate where a person works. Proof of insurance may demonstrate
the person has coverage. A plan's summary of benefits and coverage
would also indicate whether the plan covers the contraceptive services
a woman seeks. And just as projects contact third party payers to
obtain payment or contributions, projects could contact a woman's
insurer to inquire whether the plan covers the particular contraceptive
services and could ask if the lack of coverage is due to a religious or
moral objection on the part of the plan sponsor. Where a woman wants to
obtain the coverage confidentially, the project may not be able to make
such contact, but in those cases, the same difficulty would be
presented under the definition from the 2000 regulations, with respect
to whether to deem those persons as having good reasons for their
inability to pay for family planning services. The revised definition
does not add uncertainty that is not already inherent in the good
reasons discretion afforded to project directors. Rather, it adds
clarity concerning one good reason that can form the basis of that good
reason determination.
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\62\ Office of Population Affairs, Program Requirements for
Title X Funded Family Planning Projects, Health and Human Services,
12 (April 2014), https://www.hhs.gov/opa/sites/default/files/Title-X-2014-Program-Requirements.pdf (``Although not required to do so,
grantees that have lawful access to other valid means of income
verification because of the client's participation in another
program may use those data rather than re-verify income or rely
solely on clients self-report.'').
---------------------------------------------------------------------------
The Department understands the objection that project directors may
seek more specific instructions on how to implement the definition, and
also understands the concerns of some commenters who believe that women
should automatically be deemed as being from a ``low income family'' if
her employer-sponsored insurance coverage omits contraceptive services
on the basis of a religious or moral objection. Such comments reflect
that, for some women, not having contraceptive coverage may affect
their ability to pay and, thus, their economic status. In light of this
concern, and the desire to provide more specific direction sought by
commenters, the Department is finalizing the definition with the
modification that a project director may exercise discretion to
consider such women as being from a ``low income family'' or eligible
for a discount for contraceptive services on the schedule of discounts
provided for in Sec. 59.5, based on the impact that not having
contraceptive coverage may have on their ability to pay for
contraceptives.
Under the women's preventive services guidelines issued by the
Department, certain plans (or issuers or plan administrators) are
required to cover all FDA-approved contraceptives with no cost-sharing,
unless an exemption applies to the plan based on sincerely held
religious beliefs or moral convictions. See 45 CFR 147.132 (religious
exemption criteria); 45 CFR 147.133 (moral exemption criteria); see
also 45 CFR 147.131 (religious or moral accommodation criteria). In
addition, various entities with religious or moral objections have
obtained permanent injunctions from federal courts, entitling them to
exemptions from the federal contraceptive coverage requirement.\63\
Where a woman has health insurance coverage through an employer that
does not provide the contraceptive services she seeks from a project,
because her employer has a sincerely held religious or moral objection
to providing such coverage, the project director may approximate the
net effect on the woman's economic status by the average annual cost of
the contraceptive services that would have been covered if her employer
did not object. For example, if she seeks oral contraceptives, and her
employer had covered oral contraceptives without cost-sharing, she
would incur no out-of-pocket cost for oral contraceptives. If her
employer omits oral contraceptives on the basis of a religious or moral
objection, her annual cost as the result of that decision can be
approximated by the annual out-of-pocket cost she would bear for oral
contraceptives.
---------------------------------------------------------------------------
\63\ See, e.g., Catholic Benefits Ass'n LCA v. Hargan, No. 5:14-
cv-00240-R (W.D. Okla. order filed Mar. 7, 2018), and Dordt Coll. v.
Burwell, No. 5:13-cv-04100 (N.D. Iowa order filed June 12, 2018).
---------------------------------------------------------------------------
Consequently, in the final rule, the Department modifies the
example involving a woman whose employer-sponsored health insurance
does not cover contraceptives because of a religious or moral objection
on the part of the employer. In such a situation, in determining
whether such a woman's income is more than 100% of poverty level, or
whether she is subject to sliding scale discounts for contraceptive
services under Sec. 59.5, the project director may reduce the woman's
annual income by the annual out-of-pocket cost she would pay for the
desired contraceptive services. The project director may estimate the
annual cost based on the project director's expertise regarding the
costs of contraceptive services, or reduce the woman's estimated total
income by an estimated \64\ average of $600 per year. This gives the
project director additional discretion and guidance in considering the
income status of a woman whose employer omits contraceptives from her
insurance plan on the basis of a religious or moral objection.
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\64\ See 83 FR 57536, 57551 (Nov. 15, 2018) (estimating the
average annual cost of contraceptives at just under $600 per year).
---------------------------------------------------------------------------
The Department disagrees with commenters who assert that the
example is discriminatory because it only refers to women. As discussed
more fully below, the definition does not preclude men from seeking to
establish good reasons for which they are unable to pay for family
planning services. This specific example simply refers to women because
it has mainly arisen in a context related to coverage for women's
contraceptive services. A section of the PHS Act added by the
Affordable Care Act,\65\ specifies that certain group health plans and
issuers shall provide coverage, with no cost sharing, of women's
preventive services as provided by guidelines supported by the Health
Resources and Services Administration (HRSA), a component of the
Department. Section 2713(a)(4) does not apply to men and does not
provide for cost-free coverage of men's contraceptive services. Where a
woman's plan omits contraceptive coverage on the basis of religious or
moral objections, it falls into an exemption to the guidelines set
forth at 45 CFR 147.131 and 147.133. That exemption does not apply to
men's contraceptive coverage, because the
[[Page 7738]]
underlying requirement of section 2713(a)(4) does not encompass
preventive services for men. Given these circumstances, the Department
deems it appropriate to illustrate how the project director could apply
the discretion embodied in the existing low income family definition
when a woman's employer-sponsored insurance plan omits contraceptive
coverage on the basis of a religious or moral objection.
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\65\ See 42 U.S.C. 300gg-13(a)(4) as added by the Affordable
Care Act, Public Law 111-148, 124 Stat. 119, 131, sec. 1001 (adding
new PHS Act section 2713).
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The Department notes that the definition maintains the decades-old
discretion granted to the project director to deem a person as having
good reasons why he or she cannot pay for family planning and therefore
deem him or her as being from a ``low income family.'' Consequently,
project directors may also consider a man's lack of access to insurance
coverage for contraceptive services as potentially constituting a good
reason why the project will consider the man as being from a low income
family. The definition has required, and continues to require, project
directors to take into consideration such indicia of ability to pay.
This final rule mentions one specific context involving women who may
not have access to contraceptive coverage as one possible application
of the ``good reasons'' determination, but does not do so in an
exclusive way, nor does it negate the applicability of the project
director's pre-existing discretion to any person seeking services from
the project.
Some commenters ask the Department to clarify whether a woman, who
is considered as being from a low income family based in part on the
lack of contraceptive coverage in her plan due to her employer's
religious or moral objection, then qualifies to receive just the
contraceptive services that her plan omits, or qualifies to receive all
family planning services provided by the project, such as pap smears
and STD testing. The Department clarifies that a project director may
consider the woman with this insurance status as being from a low
income family, or as qualifying for sliding scale discounts, for the
purposes of her payment for the contraceptive services she seeks that
are not covered by her insurance plan. The revision does not specify
that such a woman will be deemed as being from a low income family for
the purpose of receiving other services from the Title X project.
Presumably, the woman would have insurance coverage for such other
services, and the Title X provider could bill her health insurance
company for them. Nevertheless, as noted above, the definition retains
the decades-old discretion given to the project director to make a
``good reasons'' determination to deem a person as being from a ``low
income family'' for the purposes of receiving all the services offered
in the Title X project. The example specifies and clarifies how the
project director's discretion could be applied in a particular
situation, but it does not add limitations to the project director's
discretion in other hypothetical cases raised by commenters.
Many commenters express concern that implementation of the example
would cause a financial strain on the program. The Department
disagrees. As noted above, the example does not mandate that project
directors must consider a woman as being from a ``low income family''
based on her employer's religious or moral objection to contraceptive
coverage in her insurance plan. The example simply affirms the project
director's discretion to take that fact into consideration. Project
directors are aware of long-standing flexibility when defining ``low
income,'' since the 2000 regulations do not preclude project directors
from deeming women who do not have contraceptive coverage because of
their employer's religious or moral objection to contraceptive coverage
in their insurance plans to be ``low income.'' Because the project
director already has that discretion under the 2000 regulations, the
Department disagrees that merely making this discretion even more
explicit will result in a significant number of women being granted low
income status to receive free or low cost contraceptive services from
Title X projects. Commenters did not provide data from which the
Department could reliably estimate how many women will seek to obtain
free or low cost contraceptives from Title X providers as a result of
this change and how many will then be granted ``low income family''
status by project directors.
To the extent that commenters base this objection on estimates in
rules concerning religious and moral exemptions to the contraceptive
coverage guidelines, the Department notes that such estimates were
speculative. The Department, along with the Departments of Labor and of
the Treasury, attempted to set forth various estimates concerning the
number of women who would use the exemptions, but noted that they
lacked adequate data to know whether those estimates were accurate. 83
FR 57536, 57550 (Nov. 15, 2018). The Departments made several
assumptions that they noted were likely too high. Id. at 57581. And
they emphasized that the estimate was not the number of women that they
believed would be affected by use of the exemptions by sponsors of
health insurance plans.
Even if those estimates of the women affected by the religious and
moral exemption rules were accurate, the Department could not simply
assume that all of those women would obtain contraceptive services from
a Title X project. As noted above, the proposed additional example in
this definition does not require a project director to consider a woman
to be from a low income family on this basis. Project directors might
conclude that women seeking to use the clarifying example have incomes
that, despite their lack of contraceptive coverage, render them able to
pay for contraceptive services. Moreover, it is unlikely that all women
affected by the exemption rules will seek services from Title X
projects. Some of those women may have family incomes under which they
can afford the services. Some may choose, for other reasons, not to
seek contraceptive services from Title X projects. For example, some
may share their employers' objections to such contraceptives.
The Department is not aware of data from which to reliably estimate
how many women will seek contraceptive services from Title X projects
because the sponsors of their health plans have religious or moral
objections leading them to omit contraceptive coverage from their
insurance plans, but believes that any overall cost to the Title X
program will be slight. With regard to low income women in general, the
Department is aware that significantly less than half of such women
receive services from Title X projects. In 2017, Title X projects
served more than 4 million persons of whom 90% were low income
persons.\66\ The official poverty rate in 2016 was 12.7%,\67\ therefore
encompassing more than 41 million persons.\68\ Thus, fewer than 10% of
persons eligible for low income status in Title X projects sought and
obtained Title X services. The Department estimates that an even
smaller fraction of women would be affected by the exemptions provided
for entities with religious and moral objections to providing
contraceptive coverage. And
[[Page 7739]]
the Department does not expect that the sliding scale discount
discussed above would lead to a significantly greater number of women
obtaining discounted contraceptives than would otherwise receive them.
Their incomes will only be reduced by the cost of contraceptives,
which, on average, is about $600 per year (see 83 FR at 57551), but the
Title X sliding scale discounts span several thousand dollars between
ranges. Women could thus be deemed to receive less income and still not
be eligible for discounts. Finally, Title X projects pay only a
fraction of the retail costs for contraceptive services discussed in
the religious and moral exemption final rules.
---------------------------------------------------------------------------
\66\ Christina Fowler et al., 2017 Family Planning Annual
Report, Health and Human Services, (2008), https://www.hhs.gov/opa/sites/default/files/title-x-fpar-2017-national-summary.pdf.
\67\ Jessica Semega et al., Income and Poverty in the United
States: 2016, U.S. Census Bureau, (Sept. 12, 2017), https://www.census.gov/library/publications/2017/demo/p60-259.html.
\68\ U.S. Census Bureau, Annual Estimates of the Resident
Population: April 1, 2010 to July 1, 2016, (2017), https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=bkmk.
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Consequently, the Department concludes that the number of women
whose employers have religious or moral objections leading them to omit
contraceptive coverage from their insurance plans is small compared to
the number of low income women served by Title X projects; at most, a
small minority of such women will seek contraceptive services from
Title X projects; the revision to the definition allows project
directors to consider deeming those women as being from low income
families, but it is likely that only a fraction of them will be deemed
unable to pay for family planning; and the cost to the projects of
contraceptive services provided or discounts offered is only a fraction
of the retail costs of contraceptive services. In light of these
factors, even assuming that the use of this example would lead more
women to seek to use the existing ``good reasons'' exception than had
previously, the Department does not believe it will lead to an
unreasonable strain on the Title X program.
Even if there is an economic impact on the program, it is supported
by the Title X statute. Where women are actually deemed to be from a
``low income family'' after the project director's consideration of
their insurance status, the Title X statute provides for low cost or
discounted contraceptive services. As discussed above, insurance status
is one factor that may affect a woman's overall economic status or
ability to pay for family planning services. The Department concludes
it is appropriate to clarify the ``low income family'' definition
through the proposed example, so that project directors may
appropriately extend eligibility to such women. This helps fulfill the
purposes of the Title X statute to ensure that women are not prevented
from participating in the program due to their economic status.
The Department disagrees with commenters contending these revisions
in the definition violate the Establishment Clause of the First
Amendment. The proposed example clarifies the discretion that a project
director has long had under the rules concerning good reasons why some
persons may be deemed from a low income family. Specifying that a
project director may consider a woman's lack of contraceptive coverage
as a result of a religious exemption exercised by the sponsor of her
health plan from contraceptive coverage into consideration does not
violate the Establishment Clause. The example also allows the project
director to consider a woman's lack of contraceptive coverage from a
sponsor's non-religious moral objection, or to take any number of other
non-religious factors into account as a good reason that the woman may
be unable to pay for family planning services. The Department also
disagrees with a commenter who argues that project directors should
consider whether a woman's health plan covers abortion. Title X
precludes considering abortion as a method of family planning.
Accordingly, the Department finalizes the definition of ``low
income family'' without change to the prefatory text or paragraph (1),
but with changes to paragraph (2) to emphasize that the project
director may exercise discretion under the existing ``good reason''
exception to ``consider her insurance coverage status as a good reason
why she is unable to pay for contraceptive services'' when her employer
has a sincerely held religious or moral objection to providing such
coverage. The final rule in paragraph (2) is also finalized with
guidance for the project director in making this determination.
5. Definition of Program or Project
Summary of changes: The 2000 regulations did not define a Title X
``program'' or ``project.'' The proposed rule, at Sec. 59.2 proposed
to define ``program'' and ``project'' as interchangeable and mean ``. .
. a plan or sequence of activities that fulfills the requirements
elaborated in a Title X funding announcement . . .'' The proposed
definition indicated that implementation of a Title X ``program'' or
``project'' may be completed by grantees, subrecipients, or partnering
providers working under grantees or subrecipients who deliver
comprehensive family planning services.
The Department finalizes this definition as discussed below in
response to public comment by stating ``Program and project are used
interchangeably and mean a plan or sequence of activities that is
funded to fulfill the requirements elaborated in a Title X funding
announcement; it may be comprised of, and implemented by a single
grantee or subrecipient(s), or a group of partnering providers who,
under a grantee or subrecipient, deliver comprehensive family planning
services that satisfy the requirements of the grant within a service
area.''
This clarification establishes the Department's finding that any
organization receiving Title X funds is responsible to adhere to Title
X requirements.
Comments: One commenter asked the Department to alter the
definition of ``Program or Project'' because many of the prohibitions
against using Title X funding for abortion only legally apply to the
program or project, so the commenter asked the Department to reexamine
the definition to be sure that entities cannot use the definition to
escape compliance with the rule's requirements. In addition, the
commenter suggested that the phrase ``and may be comprised of'' does
not form part of the working definition but only describes how a
program or project, as defined, may be comprised. That leaves the
legally operative definition in the proposed rule of ``program'' and
``project'' as being ``a plan or sequence of activities that fulfills
the requirements elaborated in a Title X funding announcement.''
At the same time, the commenter expresses concern that if an entity
does not fulfill all or some of the requirements of the announcement,
the program or project could argue that it does not meet this
definition, and thus can avoid the requirements of the rule. Instead,
the commenter suggests restating the definition as ``[a]n enterprise,
scheme or venture carried out or proposed to be carried out by a
grantee, subrecipient(s) or a group of partnering providers pursuant to
a Title X award granted by the Secretary.''
Response: The Department appreciates the commenter's observations
concerning whether aspects of the program and project definition might
inadvertently allow entities to avoid compliance with the requirement
of the rule. The 1988 regulations stated that ```[p]rogram' and
`project' are used interchangeably and mean a coherent assembly of
plans, activities and supporting resources contained within an
administrative framework.'' The proposed definition was similar in
referencing plans and activities. The Department agrees with the
commenter that the definition should include not only a plan or
sequence of activities that fulfills Title X requirements, but those
that seek to
[[Page 7740]]
fulfill them. A program or project is one that receives Title X
funding, as distinct from applications and proposed projects that are
not awarded funding. In response to the commenter, the Department
clarifies that, when it stated in the proposed rule that a program or
project ``may be comprised of, and implemented by a single grantee or
subrecipient(s), or a group of partnering providers who, under a
grantee or subrecipient, deliver comprehensive family planning services
that satisfy the requirements of the grant within a service area,'' it
intended those parameters to be, and those parameters will be, treated
as operative parts of the definition. The Department intends to enforce
all requirements of the Title X program with respect to any entity
receiving a Title X grant. If an applicant cannot sufficiently show
that the program will meet all the Title X requirements, then it will
not qualify for a Title X grant. Consequently, the Department finalizes
this definition by changing the word ``fulfills'' to ``is funded to
fulfill,'' and by changing the phrase ``and may'' to ``, and it may''.
6. Definition of Subrecipient
Summary of changes: The 2000 regulations do not define
subrecipient. The proposed rule, at Sec. 59.2, proposed to define
``subrecipient'' as ``any entity that provides family planning services
with Title X funds under a written agreement with a grantee or another
subrecipient. These entities may also be referred to as ``delegates''
or ``contract agencies.'''
There were no substantive comments under this section that are not
already discussed elsewhere in the preamble to this rule. The
Department finalizes this definition without change, except for minor
grammatical corrections.
D. Who is eligible to apply for a Family Planning Services Grant or
contract? (42 CFR 59.3)
Summary of changes: The proposed rule at Sec. 59.3 proposed to
delete the provision that was rendered void by means of the CRA joint
resolution of disapproval that was signed by the President, and would
make corresponding changes to the heading of the section. The
Department finalizes this section with changes in response to comments
concerning the applicability of this section to contracts. As revised,
the section would specify that ``[a]ny public or nonprofit private
entity in a State may apply for a family planning grant or contract
under this subpart.''
Comments: One commenter supports the proposed language to nullify
the provisions of the 2016 regulation and believes it will help improve
the Title X program by making it permissible to fund organizations that
do not provide artificial contraceptives. Another commenter thinks the
federal government should directly fund national family planning
organizations.
Response: The Department appreciates the support for the revocation
of the nullified 2016 regulation. Regarding the commenter who calls for
direct funding of entities that provide natural family planning, the
Title X regulations already permit, and this final rule allows, such
entities to be participating entities in Title X projects. For projects
to receive a grant, they must provide a broad range of family planning
methods and services. The Department does not prioritize providers of
one specific family planning method over another. Accordingly, the
Department believes the Title X program works most efficiently with
grantor and grantees as defined in this rule.
As discussed above in section II.B concerning Sec. 59.1, the
proposed rule would not apply Sec. 59.3 to contracts, and some
commenters asked whether Sec. 59.3 and other sections should apply to
contracts. Section 1001 of the Title X statute specifies that, ``in the
establishment and operation of voluntary family planning projects,''
the Secretary ``is authorized to make grants and to enter into
contracts with public or nonprofit private entities.'' To conform Sec.
59.3 to the scope of the statute, the Department finalizes Sec. 59.3
with changes to the title of that section to read ``Who is eligible to
apply for a family planning services grant or contract?'' Likewise, the
text of Sec. 59.3 is finalized with change to read: ``Any public or
nonprofit private entity in a State may apply for a family planning
grant or contract under this subpart.''
E. What Requirements Must be Met by a Family Planning Project? (42 CFR
59.5)
In the proposed rule, the Department proposed a number of revisions
and additions to Sec. 59.5(a)(1), (5), and (10) and (b)(1) and (8).
Each is discussed in turn.
1. Broad Range of Acceptable and Effective Family Planning Methods (42
CFR 59.5(a)(1))
a. Acceptable and Effective Methods and Services
Summary of changes: The 2000 regulations required that Title X
programs provide a broad range of acceptable and effective family
planning methods that were medically approved. The proposed rule
proposed to revise Sec. 59.5(a)(1) by removing the language,
``medically approved'' and by clarifying the acceptable and effective
family planning methods and services under Title X.
Comments: Many commenters oppose the proposed language because it
removes the phrase ``medically approved'' as a description of the broad
range of acceptable and effective family planning methods a project
must provide. Some commenters state the language could reduce access to
the safest, effective, and medically approved contraceptive methods,
increase risks associated with promoting medically unreliable methods,
place political ideology over science, and undermine recommendations
jointly issued by OPA and the CDC on Quality Family Planning. Many
commenters feel that the proposed language is misleading to patients
and could negatively impact the quality of care provided to patients,
especially to adolescents and young adults who may require hormonal
contraceptive methods which have been associated with decreased rates
of teen and unintended pregnancies.
Some commenters, however, support the proposed rule and point out
that it will increase choices for persons served by Title X projects,
allowing the government to choose the most qualified applicants instead
of the applicants who happen to provide the most services.
Response: Section 1001(a) of the PHS Act requires Title X projects
to ``offer a broad range of acceptable and effective family planning
methods and services (including natural family planning methods . .
.).'' 42 U.S.C. 300(a). The final rule at Sec. 59.5(a)(1) ensures that
the regulatory language is consistent with the statutory language.
The Department disagrees with comments that oppose removal, from
the regulatory text, of the phrase ``medically approved,'' leaving
``acceptable and effective'' to describe the family planning methods
and services to be provided by Title X projects. As noted above, the
Title X statute does not contain the phrase ``medically approved'' and
it is far from clear what that undefined phrase requires. The Title X
statute provides that Title X projects ``shall offer a broad range of
acceptable and effective family planning methods and services . . . .''
42 U.S.C. 300. That language was sufficient when Congress drafted the
Title X statute, and the Department concludes that it is sufficient
today. As such, the revision is clearly within the Department's
statutory authority. The Department disagrees with commenters
[[Page 7741]]
who contend removing this language causes the regulations (or the Title
X statute) to promote medically inaccurate information, or Title X to
be administered based on a political ideology.
The ``medically approved'' language risked creating confusion about
what kind of approval is required for a method to be deemed ``medically
approved.'' Family planning methods offered by Title X projects are
already offered by health care professionals, so, to that extent, those
methods are already medically approved. But different medical doctors
and professional organizations may differ on which methods of health
care they approve, including different methods of family planning. Some
family planning methods cannot be medically approved by a government
agency, such as the Food and Drug Administration, because they do not
fall within its jurisdiction.\69\ This does not mean that such methods
of family planning are unacceptable or ineffective in the view of
medical sources.\70\ Moreover, various medical sources may view a
particular method differently, based on different criteria, and it is
not clear what the ``medically approved'' standard would mean in a
circumstance where medical authorities differ regarding a particular
method. The statutory language of ``acceptable and effective family
methods or services,'' without the phrase ``medically approved''
provides sufficient guidance to Title X projects in considering the
types of family planning methods and services that they provide.
---------------------------------------------------------------------------
\69\ See FDA, Birth Control (March 6, 2018), https://www.fda.gov/ForConsumers/ByAudience/ForWomen/FreePublications/ucm313215.htm. See also, FDA, Enforcement Story Archive (August 7,
2003), https://www.fda.gov/iceci/enforcementactions/enforcementstory/enforcementstoryarchive/ucm106947.htm (``Warning
Letter Issued for ``Fertility Awareness Kit''). But see FDA, FDA
allows marketing of first direct-to-consumer app for contraceptive
use to prevent pregnancy (August 10, 2018), https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm616511.htm.
\70\ For example, pursuant to a contract with HRSA, in March
2016, the American College of Obstetricians and Gynecologists (ACOG)
launched the ``Women's Preventive Services Initiative.'' In its
``Clinical Recommendations,'' ACOG recommended that instruction in
fertility awareness-based methods of family planning, and
counseling, initiation of use, follow-up care, management, and
evaluation of the same, be provided with no cost-sharing in health
coverage. See Women's Preventive Services Initiative, Clinical
Recommendations Contraception, American College of Obstetricians and
Gynecologists (2018), https://www.womenspreventivehealth.org/recommendations/contraception. The Health Resources and Services
Administration (HRSA), a component of HHS, adopted this
recommendation on December 20, 2016, and added coverage of fertility
awareness-based methods of family planning to its women's preventive
services guidelines, issued pursuant to Section 2713(a)(4) of the
Affordable Care Act (42 U.S.C. 300gg-13(a)(4)). See HRSA, Women's
Preventive Services Guidelines, Health Resources & Services
Administration (October 2017), https://www.hrsa.gov/womens-guidelines-2016/index.html. On that basis, fertility awareness-based
methods of family planning could be said to be ``medically
approved.''
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The Department does not believe that the final language of the
first two sentences of Sec. 59.5(a)(1), as finalized here, would limit
access to family planning services or other necessary health care, nor
lead to an increase in unintended pregnancies.
b. Projects Required To Provide a Broad Range of Family Planning
Methods and Services, but Participating Entities May Offer a Limited
Number of Family Planning Methods and Services
Summary of changes: The Department proposed to specify in the
proposed rules that participating entities within a project would not
be required to provide every method or service. The Department further
proposed that, projects as a whole provide a ``broad range of such
family planning methods and services,'' but not be required to provide
every acceptable and effective method or service. The Department
finalizes these sentences in Sec. 59.5(a)(1) without change.
Comments: Some commenters agree with the Department that not every
project or participating entity should be required to provide all Title
X services, so long as the overall Title X project offers a broad range
of family planning methods and services. They believe that allowing
participating entities that do not offer all services will increase the
pool of potential applicants, allow projects to offer a broader range
of services by utilizing specialty providers, and allow the government
to choose the most qualified applicants.
Many commenters express concern with the language describing the
broad range of family planning methods and services that projects must
provide. Some commenters say the proposed language would reduce the
methods offered within a project by stating, ``projects are not
required to provide every acceptable and effective family planning
method or service . . . as long as the entire project offers a broad
range of such family planning methods and services.'' Commenters
express concern that projects will not be required to provide every
acceptable and effective family planning method or service, and contend
the language seems to encourage projects to not offer every acceptable
and effective family planning method or service. Many commenters state
that the proposed rules are inconsistent with the original intent of
Title X to establish as a national goal the provision of adequate
family planning services and to all those who want them but cannot
afford them. Many commenters oppose the proposed language because they
believe it will limit access to family planning services and other
necessary health care. One commenter states that the definition will
limit access to comprehensive reproductive health services, and
therefore adversely impact women's ability to attain positive economic
outcomes for themselves and their families. A commenter requests that
the Department clarify that, even if a Title X project need not provide
every acceptable and effective family planning method or service, a
project must provide a broad range of contraceptive methods. Some
commenters assert that the proposed rule may cause more abortions by
encouraging low-efficacy methods of family planning and decreasing
access to contraception and, therefore, increasing unintended
pregnancies.
Many commenters express concern regarding the language specifying
that participating entities within a project may offer a single method,
or a very limited number of methods, of family planning. Some of these
commenters suggest that this weakens the Title X program, undermining
its status as a program offering comprehensive services, and prevents
patients from making the best decisions about their health due to lack
of information or options.
Many commenters suggest that allowing participating entities that
offer limited services would divert scarce family planning dollars away
from entities that provide effective and preferred methods of
contraception and instead provide grants to entities that provide few,
if any, methods that patients find acceptable. One commenter expresses
concern that inexperienced entities might participate in the Title X
program, making navigation more challenging as patients struggle to
find providers that offer desired services. Some commenters contend
that the proposed rule opens the potential for what they call ``fake''
women's health care facilities to receive funding from Title X, and
that the proposed rule deemphasizes the importance of contraception and
the full range of family planning methods.
Some commenters express concern that the language might allow for
or encourage coercion, and might undermine the standard of health care
service delivery and outcomes. Many commenters express concern that the
rule will remove a person's choice in the selection of family planning
method.
[[Page 7742]]
Some commenters believe the proposed rule presents a potential threat
to reverse decades of progress in reducing unintended and teen
pregnancy, citing that natural family planning methods require a
regular menstrual cycle to be effective, which adolescents rarely have.
Other commenters, however, assert that there is no requirement for
each participating entity to provide all family planning services and
that this flexibility is in line with our Nation's longstanding
commitment to protecting freedom of conscience and comports with the
First Amendment.
Response: The Department finalizes without change the language
specifying that participating entities within a project ``may offer
only a single method or a limited number of methods of family planning
as long as the entire project offers a broad range of such family
planning methods and services.'' Neither the Title X statute nor the
proposed rule would permit a Title X project as a whole to provide only
one (or a limited number of) family planning methods and services. The
Department is finalizing this rule which continues to require Title X
projects to offer a broad range of family planning methods and
services.
The Department appreciates concerns of commenters who believe the
proposed language that says projects are not required to provide every
acceptable and effective family planning method or service would reduce
the range of family planning methods that Title X projects must
provide, but does not believe that this is a reasonable interpretation
of the proposed rule. To clarify, projects would continue to be
required to offer a broad range of family planning methods and
services, consistent with the statutory mandate. However, neither the
plain language of the statutory requirements, nor the 2000 regulatory
text, requires that Title X projects provide every acceptable and
effective family planning method or service. Thus, the proposed rule
and this final rule merely clarify, and make explicit, that the
requirement for a broad range of acceptable and effective family
planning methods and services does not mean every acceptable and
effective family planning method or service. Furthermore, neither the
plain language of the statute, nor the 2000 regulatory text, requires
participating entities within a project to provide every acceptable and
effective family planning method or service, or even a broad range of
such methods or services. It is permissible under the 2000 regulations
for a subrecipient within a funded project to offer only a single or
limited number of family planning methods or services. See 42 CFR
59.5(a)(1) (``If an organization offers only a single method of family
planning, it may participate as part of a project as long as the entire
project offers a broad range of family planning services.''). The same
is true under this final rule. This is permissible only if the project
as a whole provides a ``broad range'' of such methods and services. The
final rule merely acknowledges and clarifies this reality.
The Department disagrees that requiring a broad range of family
planning methods and services, while recognizing that some projects may
not offer every method or service, would lead to an increase in
unintended pregnancies. Similar to the 2000 regulations, this rule
requires the project as a whole to offer a broad range of acceptable
and effective family planning methods and services, which includes
contraceptives. While the rule clarifies the broad range of family
planning methods and services permissible under Title X, it also
ensures Title X patients are free, without coercion, to select any of
the broad range of family planning methods and services offered in a
project. The Title X statute has always provided as much, and the 2000
regulations did too.
The Department disagrees with commenters opposing the language
allowing participating entities to offer one or few family planning
methods. The 2000 regulations explicitly permits this, stating ``[i]f
an organization offers only a single method of family planning, it may
participate as part of a project as long as the entire project offers a
broad range of family planning services''; this language has been
included in regulations since at least 1988. To the extent the
commenters opposing this language do not find fault with the 2000
regulations, the Department sees no cause for concern over this
provision. About four million patients are annually served with the
current provision that allows organizations that offer only a single
family planning method to participate in a Title X project. The
Department now merely confirms this practice by stating that ``[a]
participating entity may offer only a single method or a limited number
of methods of family planning as long as the entire project offers a
broad range of such family planning methods and services.'' Therefore,
the Department disagrees with the concerns expressed about including
this sentence in the final rule.
The Department also disagrees that the proposed rule weakens the
standing of Title X programs as comprehensive sources for family
planning. The rule does not prohibit projects or providers from
offering every acceptable and effective family planning method or
service, so long as abortion is not considered a method of family
planning. The rule simply reflects, as stated in the 2000 regulations,
that Title X projects are required to provide a broad range of
acceptable and effective family planning methods and services (not
every such method or service), and that participating entities are
permitted to participate in a Title X project even if not all of them
offer every method--and, indeed, even if some participating entities
within a project offer only one family planning method. The range of
available family planning methods has significantly increased over the
last few decades. The Department believes it may be unreasonably
difficult or expensive to add a new requirement that all projects and
all participating entities must offer all acceptable and effective
forms of family planning. It may also be difficult for clients to
access certain methods in which not all participating entities have
specific training and expertise. This rule enhances the ability of
individual Title X projects to offer, and clients to access, such
methods, while preserving the requirement that individual Title X
projects offer a broad range of family planning methods and services.
The Department disagrees with some commenters who say the rule is
misleading to Title X clients. This rule is substantially similar to
the 2000 regulations rule in that it permits single method providers to
participate in the Title X program and includes natural family planning
methods as those that qualify under the ``broad range.''
The Department disagrees that the proposed and final rules
authorize Title X funding for what some commenters call ``fake''
women's health care facilities. It is not clear what such commenters
deem to be ``fake'' facilities, but nothing in the rule authorizes
projects to use clinics that engage in fraud or allow the practice of
medicine without a license. Title X projects are subject to quality
oversight by the Department and are also subject to relevant State laws
in the operation of health clinics.
The Department believes that permitting entities to provide
services for which they have particular expertise allows greater access
to family planning methods in Title X projects and contributes to
quality care for patients. The final rule does not require projects to
include participating entities that offer only one or just a few
methods, but it continues to allow them to do so, if they deem it
appropriate and consistent with offering a broad range of family
planning methods and services.
[[Page 7743]]
The final rule, thus, clarifies and reframes, but does not create
or invent the ability of a single-method entity to participate in a
Title X project. The Department believes that continuing to allow such
entities to participate will give people served under Title X access to
specialized expertise in certain methods. Increasing client choices
among family planning clinics and methods in a project is likely to
decrease unintended pregnancies, not increase them, because clients are
more likely to visit clinics that respect their views and beliefs and
to use methods that they desire and that fit their individual
circumstances.
The Department also agrees with commenters that say the final rule
is consistent with principles of the First Amendment and laws that
protect freedom of conscience. By allowing projects to use entities
that offer a single method or limited methods--including providers that
might do so for reasons of conscience--the language being finalized
will, among other things, both protect the ability of health care
providers and facilities with conscientious objections to providing
certain types of family planning methods and services to participate in
Title X projects and maintain Title X projects that offer a broad range
of family planning methods and services.
c. Listing Particular Services in the Broad Range of Family Planning
Services That May Be Provided
Summary of changes: The 2000 regulations recognized natural family
planning and services for adolescents as some of the broad range of
acceptable and effective family planning methods. The proposed rule
proposed to clarify that natural family planning and other fertility-
awareness based methods qualify as acceptable methods, as do
contraceptives. In addition, as a mechanism for addressing infertility,
the Department proposed to add adoption as a family planning service.
Therefore, the Department finalizes Sec. 59.5(a)(1) with changes to
replace the word ``and'' with the word ``or'' before the phrase ``other
fertility-awareness based methods.''
Comments: The Department received several comments about the
listing of particular services in the broad range of family planning
services that may be provided. Some commenters objected to references
to natural planning or fertility awareness-based methods because
fertility awareness-based methods are already offered at 93% of Title X
clinics and natural family planning is already a method included in the
Quality Family Planning Guidelines provided by CDC. Others object to
these methods because they assert that the methods are ineffective, or
at least among the least effective forms of family planning.
Other commenters object to language specifying adoption as a type
of family planning service. They contend that the management of
infertility, including adoption, is beyond the language and intent of
the Title X statute. They also believe that including adoption would
put a strain on the program, as it would redirect a large amount of
Title X funds. And they assert that including adoption in the
definition is contradictory because adoption is a postconception
activity and the new definition states that family planning only
includes preconception activities. Some commenters also assert that the
Department improperly redefines the meaning of a reproductive life
plan.
Response: The Department disagrees with commenters who say the rule
should not mention natural planning or additional fertility awareness-
based methods, and who contend the rule emphasizes those methods over
other forms of family planning. As discussed in the context of the
definition of family planning in Sec. 59.2, the Title X statute itself
requires projects to offer a broad range of family planning methods and
services, and specifies that those methods ``includ[e] natural family
planning methods, infertility services, and services for adolescents.''
42 U.S.C. 300(a). The Department concludes that Title X projects
(although not necessarily each provider or site within a project) must
offer both contraception and natural family planning in order for the
Department faithfully to implement Title X's ``broad range''
requirement. The proposed and final rules, far from over-emphasizing
natural family planning or emphasizing it to the exclusion of
contraceptives, add contraceptives to this non-exclusive list of
examples of family planning methods that projects must provide. The
proposed rule at Sec. 59.5(a)(1) also includes the phrase ``and other
fertility awareness-based methods'' alongside ``natural family
planning.'' As discussed concerning the ``family planning'' definition,
``natural family planning'' is not defined in the Title X statute, and
scientific advances have occurred in natural family planning methods in
the last 40 years, so that some medical professionals now refer to
related methods as ``fertility awareness-based methods.'' \71\ The
final rule does not emphasize natural family planning over other forms
of family planning.
---------------------------------------------------------------------------
\71\ See, e.g., Shawn Malarcher, et. al., Fertility Awareness
Methods: Distinctive Modern Contraceptives, 4 Global Health: Science
and Practice 13, 13 (2016), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4807745/pdf/013.pdf (stating
fertility awareness methods of contraception have been tested and
proven effective at pregnancy prevention and safe to use).
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The definition of family planning at Sec. 59.2 uses the word
``or'' before the phrase ``other fertility awareness-based methods,''
whereas the text at Sec. 59.5(a)(1) uses the word ``and.'' The
Department considers the word ``or'' to be more appropriate in both
instances. This clarifies that by ``other fertility awareness-based
methods,'' the Department is not referring to methods that are not
``natural family planning,'' nor is it requiring projects to offer
natural family planning and other fertility awareness-based methods as
if those are two different kinds of categories. Instead, by using the
word ``or,'' the Department intends for projects to have flexibility in
deciding which types of natural family planning or fertility awareness-
based methods they will offer in meeting their obligation to offer
natural family planning methods within the project. Therefore, the
Department finalizes Sec. 59.5(a)(1) with a change to replace the word
``and'' with the word ``or'' before the phrase ``other fertility-
awareness based methods.''
The language specifying that participating entities may offer only
a single method does not mention natural family planning or any other
single method. Therefore, it does not emphasize natural family planning
over other methods as some commenters contend. Under the final rule,
single-method providers are permitted in projects whether their single
method is a natural family planning method, a contraceptive method (for
example, an implant), or some other family planning method. The
Department disagrees with commenters' concerns that allowing single or
limited method entities to participate in a Title X project limits
family planning to natural family planning methods, limits what
individuals may choose, or deprives individuals of methods they may
choose. Those results have not occurred under the 2000 regulations,
which already allow for single method participating entities.
The Department also disagrees with commenters who oppose the
inclusion of adoption information as a type of infertility services
offered by Title X providers. As discussed with respect to the proposed
definition of family planning, the Title X statute does not define
``family planning,'' and the Department has always read the
[[Page 7744]]
examples it gives of family planning methods and services as being a
non-exclusive list; otherwise, Title X could fund nothing but ``natural
family planning methods, infertility services, and services for
adolescents.'' Adoption is a method of planning the size of one's
family and the spacing of children raised in one's family, and it can
be used to enlarge one's family or to plan one's family in the context
of infertility.
In addition, under Infant Adoption Awareness grants program,
Congress specified that eligible health centers (which includes Title X
clinics) should receive training on providing adoption information and
referrals, and that the Secretary should encourage the same.\72\
Accordingly, Title X projects may provide adoption information and
referrals as a preconception family planning method, especially in the
context of providing infertility services, and may provide adoption
information and referrals during postconception pregnancy counseling as
long as the pregnancy counseling satisfies the statutory requirement
that it be nondirective. Therefore, the Department considers it
appropriate to include adoption information in the non-exclusive list
of services mentioned among a possible broad range of family planning
methods and services a Title X project might offer. But consistent with
the change finalized in the definition of ``family planning,'' the
Department modifies the phrase contained in the proposed rule,
``including infertility services, including adoption, and services for
adolescents'' to provide ``including infertility services, information
about or referrals for adoption, and services for adolescents''.
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\72\ See 42 U.S.C. 254c-6 (Congress authorized the Department to
make grants ``for the purpose of developing and implementing
programs to train the designated staff of eligible health centers in
providing adoption information and referrals to pregnant women on an
equal basis with all other courses of action included in
nondirective counseling to pregnant women'').
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Importantly, the proposed language in no way limits the choices of
Title X clients or infringes on their views of what services to choose.
The final rule does not require any Title X client to pursue adoption,
natural family planning, or any other particular family planning method
or service. On the contrary, as discussed above, the definition of
family planning is finalized to specify that ``[f]amily planning
methods and services are never to be coercive and must always be
strictly voluntary.''
2. Projects Shall Not Provide, Promote, Refer for, or Support Abortion
as a Method of Family Planning (42 CFR 59.5(a)(5))
Summary of changes: The 2000 regulations prohibited Title X
projects from providing abortion as a method of family planning. They
also specified that Title X projects must provide information on,
counseling regarding, and referral for, a variety of services for
pregnant women, including abortion. The proposed rule, at Sec.
59.5(a)(5), instead proposed to emphasize the duty of Title X providers
to ``[n]ot provide, promote, refer for, support or present abortion as
a method of family planning.'' The proposed rule would allow
nondirective pregnancy counseling, but would delete the current
language in that paragraph (including (i) and (ii)), which stated that
``[a] project must . . . [o]ffer pregnant women the opportunity to be
provided information and counseling regarding . . . [p]renatal care and
delivery; [i]nfant care, foster care, or adoption; and [p]regnancy
termination'' and that a project must, ``[i]f requested to provide such
information and counseling, provide neutral, factual information and
nondirective counseling on each of the options, and referral upon
request, except with respect to any option(s) about which the pregnant
woman indicates she does not wish to receive such information and
counseling.'' See 42 CFR 59.5(a)(5).
At Sec. Sec. 59.14 and 59.16, the proposed rule proposed more
specific parameters to implement the requirement in Sec. 59.5(a)(5)
that ``[a] Title X project may not perform, promote, refer for,
support, or present abortion as a method of family planning . . .'' and
to implement the requirement that any pregnancy counseling provided by
Title X projects must be nondirective. The proposed rule addressed in
this section relates to the proposal to remove the requirement for
nondirective pregnancy counseling and referral (including the
obligation to counsel on, and refer for, abortion), and replace it with
a prohibition in Sec. 59.5(a)(5) on the use of Title X funds to
perform, promote, refer for, support, or present abortion as a method
of family planning. Comments discussing pregnancy counseling are
discussed in a distinct part of this preamble, as are comments
discussing the deletion of the requirement to refer for abortions.
Comments discussing the prohibition on abortion referrals, and
permissible referral activities in general, are discussed with regard
to section Sec. Sec. 59.14 and 59.16.
The Department finalizes the proposed rule in Sec. 59.5(a)(5) with
one change to make it clear that providers are allowed to provide
nondirective pregnancy counseling about abortion, by removing
``present'' from the proposed list of prohibitions regarding abortion
as a method of family planning.
Comments: Many commenters support eliminating the requirement that
Title X family planning providers counsel for, provide information
about, and refer for abortion, citing protections found in health care
conscience laws and principles. Such commenters contend that the
requirement in the 2000 regulations of abortion referrals, information
and counseling is inconsistent with section 1008 of Title X, and with
the conscience protections provided for in laws such as the Church,
Coats-Snowe, and Weldon Amendments. Commenters also contend the
proposed language appropriately protects and recognizes the importance
of religious freedom and freedom of speech.
Other supportive commenters note that the 2000 regulations stand in
the way of some organizations applying for Title X funds, or
participating in Title X projects, due to the requirement for abortion
referrals and information. Such commenters contend the 2000 regulations
limit choice for patients, especially those who live in rural or remote
areas, where faith-based and local community organizations would be
more likely to apply if the abortion counseling and referral
requirement were lifted.
Some commenters express concerns related to federal conscience
protections, including the Weldon, Coats-Snowe, and Church Amendments,
that may apply to Title X grantees and subrecipients. The Church
Amendments prohibit grantees from discriminating in ``the employment,
promotion, or termination of employment of any physician or other
health care personnel'' or ``the extension of staff or other privileges
to any physician or other health care personnel'' because ``he
performed or assisted in the performances of a lawful sterilization
procedure or abortion. . . .'' 42 U.S.C. 300a-7(c). One commenter asks
that the final rule include similar conscience protections for health
care personnel who refuse to engage in family planning research or
services that are contrary to their religious beliefs or moral
convictions. A commenter also requests clarification on whether this
provision would require religious or pro-life groups who receive Title
X funds to hire someone who disagrees with their religious and moral
convictions
[[Page 7745]]
regarding abortion. Other commenters seek clarity on whether Title X
projects must hire personnel who disagree with certain family planning
methods. Some commenters state there is no need for further regulatory
review to protect the rights of those who decline to participate in
abortion-related services, but rather, contend there is a need to
protect the rights of those who conscientiously provide and seek
abortion-related services.
Several commenters disagree with the proposed rule's elimination of
the abortion information, counseling, and referral requirements. Such
commenters argue that withholding information about pregnancy options
interferes with the patient-provider trust relationship, is
contradictory to patient-centered care, and compromises the health of
the patient, as well as the ability of the patient to make timely and
fully informed decisions. One commenter states that some patients are
surprised to hear abortion is legal and have other misconceptions about
the procedure, making it imperative that comprehensive information
about abortion be shared with those patients.
Some commenters contend that restricting counseling for and
information about abortion in Title X projects would encroach on
physicians' codes of ethics and responsibilities to patients. Many
commenters state that prohibitions on abortion counseling and referral
would directly conflict with the requirements or codes of ethics of
medical professional associations, including the American College of
Physicians and the American College of Obstetricians and Gynecologists.
These associations state that patients should receive full and accurate
information to inform their health care decisions. For example,
commenters refer to the American Medical Association Code of Medical
Ethics that providers should ``present relevant information accurately
and sensitively, in keeping with the patient's preferences'' and that
``withholding information without patient's knowledge or consent is
ethically unacceptable.'' Some commenters contend that the restriction
on referral, and on directive abortion counseling, may put providers at
risk of medical liability since a delay or failure to diagnose is one
of the top three liability allegations cited by ob-gyns, who are
already at an elevated liability risk compared to their colleagues.
One commenter takes the view that the rule should prohibit Title X
from offering nondirective counseling on abortion altogether. The
commenter proposes instead that providers should provide only life-
affirming counseling to pregnant clients who consent to receive such
counseling. The commenter says this approach would protect the
conscience rights of certain organizations and their employees.
Response: The Department believes the requirement to provide
information, counseling, and referral for abortion in the 2000
regulations is incorrect and inconsistent with a number of federal
conscience protection statutes and, at least with respect to referral,
with section 1008's prohibition on funding Title X projects where
abortion is a method of family planning. As described in the preamble
to the 1988 regulations, prior to issuance of any regulations pursuant
to Title X, the Department had, since 1972, interpreted section 1008
not only as prohibiting the provision of abortion but also as
prohibiting Title X projects from in any way promoting or encouraging
abortion as a method of family planning. See 53 FR 2922, 2923. Based on
the legislative history, the Department has also, since 1972,
interpreted section 1008 as requiring that the Title X program be
``separate and distinct'' from any abortion activities of a grantee.
Although the Department had generally permitted activities that did not
have the immediate effect of promoting abortion, or the principal
purpose or effect of promoting abortion, the Department also provided
in its 1988 Title X regulations that ``a Title X project may not
provide counseling concerning the use of abortion as a method of family
planning or provide referral for abortion as a method of family
planning.'' The 1988 regulations added that ``[a] Title X project may
not use prenatal, social service, emergency medical, or other referrals
as an indirect means of encouraging or promoting abortion as a method
of family planning.'' 53 FR at 2945.
Since that time, however, Congress has contemplated that
nondirective pregnancy counseling may be offered in Title X projects.
The HHS fiscal year 2019 appropriations act provides that ``amounts
provided to said projects under such title shall not be expended for
abortions, that all pregnancy counseling shall be nondirective. . . .''
\73\ Similarly, the statute establishing the Infant Adoption Awareness
program directed the Department to include ``nondirective counseling to
pregnant women.'' 42 U.S.C. 254c-6.
---------------------------------------------------------------------------
\73\ HHS Appropriations Act 2019, Public Law 115-245, Div. B,
132 Stat. 2981, 3071. This provision has been inserted into various
HHS appropriations acts since first adopted in the 1996
Appropriations Act. See, e.g., Consolidated Appropriations Act 2018,
115 Pub. L. 141, Div. H., 132 Stat 348, 717; Consolidated
Appropriations Act 2017, 115 Pub. L. 31, Div. H, 131 Stat. 135, 521.
---------------------------------------------------------------------------
The Department has carefully considered the provision of counseling
and information about abortion in the Title X context in light of
Section 1008, the appropriations riders in place since 1996 that all
counseling be nondirective, public comments, policy considerations, and
the Department's historical positions. As a result, the Department
concludes that:
Title X projects will not be required to refer for
abortion (and, as discussed in regard to Sec. 59.14, referrals for
abortion as a method of family planning are prohibited).
Physicians or APPs within Title X projects may offer
pregnancy counseling, including counseling that addresses the option of
abortion among other options, so long as the counseling is nondirective
and does not include referrals for abortion as a method of family
planning.
Title X projects will not be required to offer
nondirective pregnancy counseling in general, or abortion information
and counseling specifically.
In stating that ``all pregnancy counseling shall be nondirective,''
Congress did not explicitly require pregnancy counseling, nor prohibit
such counseling from discussing abortion if the counseling is
nondirective. Unlike abortion referral, nondirective pregnancy
counseling would not be considered encouragement, promotion, support,
or advocacy of abortion as a method of family planning, which would be
prohibited by the Title X statute and this final rule. Therefore, the
approach of this final rule is more permissive than the 1988
regulations, which prohibited any counseling concerning the use of
abortion as a method of family planning, but predated Congress's
directive that all pregnancy counseling in the program be nondirective.
Therefore, the Department finalizes without change the proposed rule's
deletion of the language in Sec. 59.5(a)(5) requiring pregnancy
options information and counseling, including requiring information,
counseling and referrals for abortion. Consistent with that rescission
of Sec. 59.5(a)(5)(i) and (ii), there is no requirement in the final
rule that a project offer nondirective counseling or information about
abortion. The rule does not, however, prohibit nondirective pregnancy
counseling by physicians or APPs, even if that counseling discusses
abortion.
Some commenters urge the Department to prohibit nondirective
counseling concerning abortion in a way similar to the 1988
regulations. The Department acknowledges that it has the
[[Page 7746]]
discretion to interpret section 1008 as it did in the 1988 regulations,
but it disagrees that it must prohibit discussion of abortion in
nondirective pregnancy counseling. Instead, the Department interprets
Congress's directive that all pregnancy counseling be nondirective as
permitting the Department to allow nondirective pregnancy counseling
even if such counseling includes abortion among other options.
Nevertheless, the Department also agrees, to take a phrase from the
1988 regulations, that Title X projects should not use the permission
to provide pregnant patients certain information through nondirective
counseling ``as an indirect means of encouraging or promoting abortion
as a method of family planning.'' Title X projects and service
providers must be careful that nondirective counseling related to
abortion does not diverge from providing neutral, nondirective
information into encouraging or promoting abortion as a method of
family planning, or into referral for abortion as a method of family
planning. The Department anticipates that it may provide further
guidance to grantees on this issue.
Some commenters contend this rule will deprive women of the
information they need about abortion or where to obtain one, but the
purpose of Title X is not to provide such information. To the contrary,
Congress expressly restricted the Department from funding Title X
projects where abortion is a method of family planning. Title X
programs, accordingly, may offer information about abortion only as
part of nondirective pregnancy counseling. The primary focus of Title X
remains on preconception family planning methods and services. In
implementing section 1008, moreover, the Department has a history of
establishing prohibitions on abortion referral, even if at other times
it has allowed or required such referrals. The 1988 regulations, for
example, prohibited Title X projects from providing abortion
information, counseling or referrals. The 2000 regulations took a
different approach by requiring information, counseling and referrals
for abortion as a method of family planning in certain cases. The
Department has now reconsidered this issue and believes the approach
taken in this final rule is a better interpretation of section 1008,
consistent with the subsequent Congressional directive that all
pregnancy counseling be nondirective. Further, in the Department's
view, it is not necessary for women's health that the federal
government use the Title X program to fund abortion referrals,
directive abortion counseling, or give to women who seek abortion the
names of abortion providers. Information about abortion and abortion
providers is widely available and easily accessible, including on the
internet.
The Department disagrees with commenters who assert that
prohibiting referrals or directive counseling about abortion violates
the First Amendment rights of grantees or subrecipients. The Supreme
Court explicitly rejected this claim in Rust, upholding the provisions
of the 1988 regulations ``prohibiting counseling, referral, and the
provision of information regarding abortion as a method of family
planning.'' Rust, 500 U.S. at 193. The Court explained that the
challenged provisions are permissible because they ``are designed to
ensure that the limits of the federal program are observed. . . . This
is not a case of the Government `suppressing a dangerous idea,' but of
a prohibition on a project grantee or its employees from engaging in
activities outside of the project's scope.'' Rust, 500 U.S. at 193-94.
The Court rejected the argument that the restrictions constitute
impermissible viewpoint discrimination, and instead held the government
may ``choose[] to fund a program dedicated to advance certain
permissible goals,'' even when ``in advancing those goals necessarily
discourages alternative goals.'' Id. at 194. The same principles would
sustain this rule under the First Amendment. In fact, this rule is more
permissive of speech than the regulations upheld by Rust, because this
rule allows physicians or APPs to provide nondirective pregnancy
counseling even if it discusses abortion, as long as the project does
not promote, encourage, or refer for abortion as a method of family
planning.
The Department appreciates comments that discuss how conscience
laws such as the Church, Coats-Snowe, and Weldon Amendments apply in
the context of the Title X program. In deciding to rescind the
requirement that Title X projects counsel, provide information on, and
refer for abortion, the Department concludes those requirements in the
2000 regulations are not consistent with federal conscience laws. As
explained in the preamble to the proposed rule, the Department had
already acknowledged this problem in the preamble to the 2008
regulations implementing these conscience protections. 73 FR 78087.
There, the Department observed, ``[w]ith regards [sic] to the Title X
program, commenters are correct that the current regulatory requirement
that grantees must provide counseling and referrals for abortion upon
request (42 CFR 59.5(a)(5)) is inconsistent with the health care
provider conscience protection statutory provisions and this
regulation. The Office of Population Affairs, which administers the
Title X program, is aware of this conflict with the statutory
requirements and, as such, would not enforce this Title X regulatory
requirement on objecting grantees or applicants.'' Id. Although those
2008 conscience statute regulations were partially repealed in 2011, 76
FR 9968 (Feb. 23, 2011), the underlying statutes remain valid and in
place, and the reasoning in the preamble to the 2008 regulations on
this point remains persuasive.\74\
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\74\ As noted in the proposed rule, the Department has issued a
proposed rule that would expand the Department's enforcement ability
with respect to federal conscience protection and related anti-
discrimination laws. Protecting Statutory Conscience Rights in
Health Care; Delegations of Authority, 83 FR 3880 (Jan. 26, 2018).
---------------------------------------------------------------------------
The Department continues to conclude that the abortion referral and
counseling requirements in the 2000 regulations cannot be enforced
against objecting grantees or applicants, and that such requirements
cannot be used to deny participation in the Title X program or a Title
X project comprised of objecting family planning providers. The 2000
regulations required that projects provide information about abortion,
counsel a client about abortion if she asks for it, and refer her for
abortion. However, the Weldon Amendment prohibits the federal
government from engaging in discrimination against a health care entity
on the basis that it does not, among other things, refer for abortion.
The Coats-Snowe Amendment also prohibits the federal government and
State and local governments that receive federal financial assistance--
such as State and local health departments that receive Title X funds--
from discriminating against a health care entity on the basis that it
refuses to ``provide referrals'' for abortion or refuses to ``make
arrangements for'' providing referrals for abortion. To ensure
compliance with these and other federal conscience laws, this final
rule does not require Title X projects to provide any nondirective
counseling, information, or referral for abortion. In order to ensure
compliance with section 1008, the Department affirmatively prohibits
referrals for abortion. The Department thus concludes that these
federal conscience protection laws, along with its interpretation of
section 1008, support its decision to finalize the rescission of the
requirement in the
[[Page 7747]]
2000 regulations that projects provide abortion information,
counseling, and referral in Sec. 59.5(a)(5).
The Department appreciates the concerns of commenters about other
ways in which federal conscience laws might apply in Title X projects,
for example, whether they require Title X providers to hire personnel
with certain views or objections, or prohibit entities from firing an
individual willing to perform an abortion, or who has done so in the
past. The Department intends to operate the Title X program consistent
with federal conscience laws, the First Amendment, the Religious
Freedom Restoration Act, and similar federal laws. The Department also
notes that the Title X statute itself explicitly prevents programs from
receiving Title X funds where abortion is a method of family planning.
Accordingly, any Title X project must ensure compliance with this final
rule to receive Title X funds. The Title X statute has coexisted with
federal conscience laws for over 40 years. The limitation on referral
for abortion as a method of family planning in this final rule, along
with the removal of the abortion counseling, information, and referral
requirements, is consistent with these statutory provisions. Just as
Rust affirmed the government's right to place such limits on the Title
X program, the Department concludes that it can fully achieve the goals
of the Title X program while faithfully enforcing federal conscience
laws.
The Department declines the invitation of a commenter to expand
these final rules to further address the protection of conscience in
the Title X program. First, because the Department did not propose such
provisions in the proposed rule and did not expressly request comment
on the issue, it does not have the benefit of extended comment on the
issue. Second, the Department does not believe further clarification of
this issue is necessary in this final rule, when the federal health
care conscience laws are already the subject of separate rulemaking.
The Department also will not address in this rule individual
qualifications for staff hiring by a Title X program for services
performed before or outside the Title X program, nor accept one
commenter's invitation to add provisions to implement the Religious
Freedom Restoration Act as it may apply to personnel who work for
entities participating in Title X projects. Rather, the Department
simply notes that the Office of Population Affairs bears the
responsibility for holding grantees responsible for complying with
federal conscience laws in the Title X program. In addition, the HHS
Office for Civil Rights has been designated to receive complaints of
conscience law violations and to coordinate with the relevant program
office with respect to such complaints.
The Department does not agree with the commenter who proposes that
Title X providers provide prenatal care. While the Department agrees
that prenatal care is important to maternal and infant outcomes, the
primary purpose of the Title X program is to provide preconception
family planning services. Nondirective counseling and referrals for
postconception services--although not the provision of postconception
health care services themselves--are the appropriate approach in the
context of pregnancy, so long as they do not include referral for
abortion as a method of family planning. Within a Title X project,
Title X providers may not provide prenatal care because it is outside
the scope of the project, but must refer for prenatal care as pregnancy
makes such referral medically necessary. However, the Department
encourages Title X grantees either to offer comprehensive primary
health services onsite (although outside the scope of the Title X
project) or to have a robust referral linkage with primary health
providers who are in close physical proximity to the Title X site.
The Department agrees with commenters that say the Department
should offer more guidance concerning how projects that provide
nondirective pregnancy counseling should do so consistent with
applicable Title X statutory requirements. The proposed rule set
boundaries on Title X projects concerning referral for, encouragement
of, promotion of, advocacy for, support for, and assistance with,
abortion as a method of family planning, and those boundaries would
also apply to any nondirective pregnancy counseling that physicians or
APPs provide within the Title X project. The proposed rule did not
further specify the parameters of such counseling, for example by
defining ``nondirective.'' Nevertheless, projects must comply with
Congress's requirement that pregnancy counseling be nondirective, and
the Department must enforce that requirement.
Therefore, the Department offers the following guidance on the
requirement of nondirective pregnancy counseling. When a woman is
confirmed to be pregnant, a physician or APP may provide nondirective
pregnancy counseling. While all pregnancy counseling must be
nondirective, in compliance with Congress's consistent direction
through the HHS appropriation laws, this rule permits the physician or
APP to exercise discretion on whether to offer such counseling.\75\
Nondirective counseling is designed to assist the patient in making a
free and informed decision. In nondirective counseling, abortion must
not be the only option presented by physicians or APPs; otherwise the
counseling would violate not only the Congressional directive that all
pregnancy counseling be nondirective, but also the prohibitions in this
rule on encouraging, advocating, or supporting abortion as a method of
family planning, which the Department prohibits in order to implement,
among other provisions, section 1008. Each option discussed in such
counseling must be presented in a nondirective manner. This involves
presenting the options in a factual, objective, and unbiased manner and
(consistent with other Title X requirements and restrictions) offering
factual resources that are objective, rather than presenting the
options in a subjective or coercive manner. Physicians or APPs should
discuss the possible risks and side effects to both mother and unborn
child of any pregnancy option presented, consistent with the obligation
of health care providers to provide patients with accurate information
to inform their health care decisions.
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\75\ While the decision to offer nondirective counseling is
subject to the discretion of physicians and APPs, this rule requires
referral for prenatal care in these situations because it is a
medically necessary care for all pregnant women. In any case, all
pregnancy counseling must be nondirective.
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Title X projects should not use nondirective pregnancy counseling,
or referrals made for prenatal care or adoption during such counseling,
as an indirect means of encouraging or promoting abortion as a method
of family planning. They should not use such counseling or referrals to
steer clients to abortion or to specific providers because those
providers offer abortion as a method of family planning. Referrals for
abortion as a method of family planning may not be offered. If the
patient is provided a list or the contact information of licensed,
qualified, comprehensive primary health care service providers
(including providers of prenatal care), the list--and the Title X
staff--must not identify to the woman which, if any, providers on the
list offer abortion.
Referrals for abortion for emergency care purposes are not
prohibited.\76\
[[Page 7748]]
Permitted referrals under this scenario include one in which a medical
emergency is revealed, such as when a woman has a suspected ectopic
pregnancy.\77\ Because prenatal care is medically necessary for
pregnancy, prenatal care referral is required and does not, under this
final rule, render any pregnancy counseling impermissibly directive.
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\76\ Similarly, in cases involving rape and/or incest, it would
not be considered a violation of the prohibition on referral for
abortion as a method of family planning if a patient is provided a
referral to a licensed, qualified, comprehensive health service
provider who also provides abortion, provided that the Title X
provider has complied with any applicable State and/or local laws
requiring reporting to, or notification of, law enforcement or other
authorities and such reporting or notification is documented in the
patient's record.
\77\ However, as with nondirective pregnancy counseling on
abortion, Title X projects and service providers must ensure that
they do not, under the cover and pretext of providing such abortion
referral, actually refer for abortion as a method of family
planning. This is an area in which Title X projects can expect OPA
monitoring and oversight and should maintain appropriate records to
support such referrals.
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Referrals for, and information about, adoption are also permitted,
as long as the counseling remains nondirective. Title X projects are
not required to offer nondirective counseling or information on
abortion.
Referring for adoption or prenatal care, but not for abortion, does
not, in the Department's view, make pregnancy counseling directive in
light of Congress's legislative directives applicable to the Title X
program. Where care is medically necessary, as prenatal care is for
pregnancy, referral for that care is not directive because the need for
the care preexists the direction of the counselor, and is, instead, the
result of the woman's pregnancy diagnosis or the diagnosis of a health
condition for which treatment is warranted. Moreover, seeking prenatal
care is not the same as choosing the option of childbirth. Regarding
adoption referrals, in Infant Adoption Awareness grants and the Infant
Adoption Awareness Training Act, Congress made clear that the provision
of adoption information and referrals do not necessarily render
pregnancy counseling directive.\78\ By contrast, Congress has
prohibited funding projects where abortion is a method of family
planning. That disparate treatment in Congress's legislative directives
makes it appropriate to prohibit referrals for abortion as a method of
family planning, including during nondirective pregnancy counseling,
while permitting (and in some instances, mandating) referrals for other
purposes.
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\78\ The Act calls for Title X project staff to have access to
training on including adoption information and referrals ``in
nondirective counseling to pregnant women'', where Infant Adoption
Awareness grants are in operation. 42 U.S.C. 254c-6(a)(6)(A).
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The Department disagrees with commenters who contend the rule will
require health care professionals to violate medical ethics,
regulations concerning the practice of medicine, or malpractice
liability standards. In Rust, the Supreme Court upheld the prohibition
in the 1988 regulations on both referral for, and counseling about,
abortion in the Title X program. The Department does not believe the
Court in Rust upheld a rule that required the violation of medical
ethics, regulations concerning the practice of medicine, or malpractice
liability standards. Federal and State conscience laws, in place since
the early 1970s, have protected the ability of health care personnel to
not assist or refer for abortions in the context of HHS funded or
administered programs (or, under State law, more generally). Indeed, in
Roe v. Wade, 410 U.S. 113 (1973), the Court favorably quoted the
proceedings of the American Medical Association House of Delegates 220
(June 1970), which declared ``Neither physician, hospital, nor hospital
personnel shall be required to perform any act violative of personally-
held moral principles.'' See Roe, 410 U.S. at 144, n.38. And in NIFLA
v. Becerra, the Supreme Court upheld conscience objections to making
certain statements, despite objections from professional medical
organizations that similarly asserted medical ethics standards. Nat'l
Inst. of Family & Life Advocates v. Becerra, 138 S. Ct. 2361, 2371-76
(2018).\79\ The restrictions on referral for, encouragement of,
promotion of, advocacy for, support of, and assistance of, abortion in
Title X only apply to abortion as a method of family planning, not for
any other reason that might give rise to malpractice liability, and the
final rule has a specific provision in Sec. 59.14(c), allowing
referrals in case of emergencies.
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\79\ See e.g. U.S. Supreme Court Amici Curiae Brief of the
American Academy of Pediatrics, California, the American College of
Obstetricians and Gynecologists, et al., NIFLA, No. 16-1140 (U.S.
Ct) (filed Feb. 27, 2018).
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As the Supreme Court affirmed, section 1008 and its implementing
regulations are simply a matter of Congress's choice of what activities
it will fund, not about what all clinics or medical professionals may
or must do outside the context of the federally funded project. The
Department believes that medical ethics, regulations concerning the
practice of medicine, and malpractice liability standards are not
inconsistent with this final rule. The Supreme Court upheld similar
conditions and restrictions in Rust as a constitutionally permissible
exercise of Congress's Spending Power. As federal law, these
requirements apply to federal grantees, notwithstanding any potential
State law to the contrary.
3. Removal of the Requirement for Consultation (42 CFR 59.5(a)(10))
Summary of changes: The 2000 regulations, at Sec. 59.5(a)(10)(i),
``[p]rovide that if an application relates to consolidation of service
areas or health resources or would otherwise affect the operations of
local or regional entities, the applicant must document that these
entities have been given, to the maximum feasible extent, an
opportunity to participate in the development of the application. Local
and regional entities include existing or potential subrecipients which
have previously provided or propose to provide family planning services
to the area proposed to be served by the applicant.'' The proposed rule
would remove that requirement and paragraph. The proposed rule would
redesignate the provision that existing or potential subrecipients be
given an opportunity for maximum participation in the ongoing policy
decisions of the project, from Sec. 59.5(a)(10)(ii) to Sec.
59.5(a)(10). The Department finalizes this part of the rule without
change.
Comments: Many commenters are concerned that this change would open
the door for multiple projects in one region, uncoordinated care, and a
disruption in the currently successful Title X network by excluding
current providers that have the expertise to provide quality services.
Some commenters recommend that the language in Sec. 59.5(a)(10) remain
unchanged to preserve opportunities for local stakeholder input.
Response: The Department disagrees with commenters who challenge
removing the consultation requirement at Sec. 59.5(a)(10). Title X
requires the Department to issue grants that provide a broad range of
acceptable and effective family planning methods and services.
Encouraging competition among applicants is conducive to achieving the
goals of the Title X statute. The Department concludes that it is not
necessary, and is potentially counterproductive, to require new
applicants to first consult with pre-existing providers, as currently
required by Sec. 59.5(a)(10)(i), although they may choose to do so.
New applicants bring fresh ideas and innovative approaches to serving
patients with their family planning needs. Requiring new applicants to
consult with previous or current grantees could have the
[[Page 7749]]
unintended consequence of quashing new ideas in favor of maintaining a
potentially sub-par status quo in a given locale. The Department agrees
it is important that new applicants build robust community partnerships
in order to expand the reach of Title X services. In some cases,
awareness of a region's existing services might strengthen an
application, so applicants might continue to be incentivized to consult
existing grantees. But the Department will not require consultation
with previous grantees as a prerequisite to application. The Department
will continue to review applications based on their quality and to fund
those best positioned to achieve the goals of the Title X statute and
the criteria set forth in the final rule.
The Department disagrees with commenters who contend current Title
X providers will necessarily be shut out as future Title X providers.
Removal of this consultation requirement does not prejudge whether
current grantees will continue to receive Title X grants, nor whether
new applicants will receive grants. The Department, likewise, does not
believe that the removal of the consultation requirement will lead to
uncoordinated care. Of course, applicants may voluntarily choose with
whom they partner and with whom they consult, and such coordination may
strengthen an applicant's proposal. However, the Department believes
the removal of this as a requirement encourages a broader range of
applicants and permits innovative approaches that may not have been
envisioned or supported in the past.
The Department finds no evidence to support the assertion that the
final rule will drive current providers from the Title X program. Under
the final rule, the government will choose from the most qualified
applicants in order to achieve the statutory goals of the program. The
fact that some applicants received funding in the past is not a
guarantee of future funding, but neither is it a guarantee that their
funding will end in the future. Encouraging new applicants in the
program could improve both the quality and breadth of service within
the Title X program; it does not reflect a preference for new
applicants over previous grantees.\80\
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\80\ The removal of the requirement for consultation likewise
does not violate the requirement in Title X section 1001(b) that
``[l]ocal and regional entities shall be assured the right to apply
for direct grants and contracts . . ., and the Secretary shall by
regulation fully provide for and protect such right'', which only
addresses the right of certain entities to apply for direct grants
and contracts. 42 U.S.C. 300(b).
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4. Promotion of Access to Comprehensive Primary Health Services (42 CFR
59.5(a)(12))
Summary of changes: The proposed rule included a new Sec.
59.5(a)(12), which stated, ``In order to promote holistic health and
provide seamless care, Title X service providers should offer either
comprehensive primary health services onsite or have a robust referral
linkage with primary health providers who are in close physical
proximity to the Title X site.'' The Department finalizes this
provision with only stylistic changes to improve readability.
Comments: Many commenters state that providing comprehensive
primary care onsite or through a robust referral linkage is not
conducive or appropriate for Title X service providers, as many
patients prefer to have their reproductive health managed by a
specialist. Many commenters express that specialists have the most up-
to-date knowledge of their specialty, and this is why many primary care
providers in turn refer out to those specialists. Many commenters
additionally indicate that this rule would create an administrative
burden and result in less primary care. Many commenters state that the
Department's proposed primary care requirement, including regarding a
robust referral linkage, is unclear, and the regulatory text would fail
to give sufficient notice to Title X grantees about the obligations
under the rule.
A commenter supports the new text and expresses the view that the
rule would amend the criteria for grants and increase competition to
encourage a broader, more diverse, applicant pool.
Response: The Department concludes that it is appropriate to
encourage Title X service providers to have comprehensive primary
health services onsite (although such services cannot be billed to the
Title X program, unless it serves the goals of the program) or to build
a robust referral linkage with primary health providers who are in
close physical proximity to the Title X site. The 2000 regulations have
similar provisions at Sec. 59.5(b)(2) and (8), requiring projects to
provide ``referral to and from other social and medical services
agencies'' and ``coordination and use of referral arrangements with
other providers of health care services, local health and welfare
departments, hospitals, voluntary agencies, and health services
projects supported by other federal programs.'' Like the 2000
regulations, the final rule allows for a referral linkage if projects
do not offer comprehensive health services onsite. The final rule adds,
however, that such referral entities should be in close proximity to
the service site, and places additional emphasis on projects providing
services onsite. The Department considers this change appropriate to
help minimize the difficulty of patients receiving needed health care
outside of Title X services.
The Department believes that the connection between Title X
services and comprehensive primary care decreases the overall cost and
transportation challenges to obtain needed health care services
identified as a result of routine family planning screening and
consultation. A 2013 Child Trends Research Brief, ``The Health of Women
Who Receive Title X supported Family Planning Services,'' found that
60% of women receiving care at Title X clinics report that the clinic
is their primary source for health care, yet many fear they cannot
address other health concerns with their family planning provider,
making the need for a linkage to comprehensive primary care providers
essential for women's health.\81\ The report also found that women who
receive care at Title X clinics generally have worse health status than
women who receive services elsewhere, and that, of such women, (1) over
25% report at least 3 health concerns; and (2) one-third are obese,
with an additional 29% being overweight.\82\ The placing of Title X
services in the context of a comprehensive primary care setting or with
strong referral networks to such care is consistent with Congress's
expectation. In the 1975 Title X reauthorization, the Senate Report
stated: ``The Committee believes that Family Planning Services under
Title X generally are most effectively provided in a general health
setting and thus encourages coordination and integration into all
programs offering general healthcare.'' S. Rep. No 63, 94 Cong., 1st
Sess. 65-66 (1975), reprinted in 1975 US Code Cong. & Admin News 469,
528.
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\81\ Elizabeth Wildsmith et al., The Health of Women who Receive
Title X-Supported Family Planning Services, Child Trends, 1 (Dec. 1,
2013), https://www.childtrends.org/publications/the-health-of-women-who-receive-title-x-supported-family-planning-services.
\82\ Id.
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Since Title X family planning services are primarily limited to
preconception services, it is important that Title X sites assist
clients with onsite care outside of the Title X project itself, or at
least with referrals to local providers, to achieve optimal
preconception and general health outcomes. Since any sexually active
woman of childbearing age could become pregnant, the inclusion of
preconception health screenings in the continuum of family planning
care is
[[Page 7750]]
important for clients, whether or not seeking pregnancy. Access to
comprehensive preconception health care is also important to family
planning outcomes because pregnancy may stress and affect extant health
conditions. Linkages to comprehensive primary health care may be
critical to ensure that pregnancy does not negatively impact such
conditions. In addition, the greatest risks affecting the health of a
baby occur early in a pregnancy--often before a woman realizes she is
pregnant--such that helping women achieve optimal preconception health
is important to ensure healthy pregnancies (as well as healthy babies)
should conception occur.
The Department disagrees with commenters who contend this language
concerning the proximity of comprehensive primary health care cannot be
implemented by Title X service providers that specialize in family
planning. First, as part of providing comprehensive primary health
care, clinic may employ, among other providers, health care providers
who specialize in family planning. Second, the primary care provision
presents two options, onsite comprehensive primary care and referrals;
it does not require the provision of onsite comprehensive primary care
by Title X service providers. The Department believes this
clarification addresses some concerns of commenters who feared that
specialized providers could not provide all the services that an
individual may need. The final rule also does not permit primary care
to be subsidized by Title X funds, unless it serves the goals of the
program. Thus, the requirement for Title X service providers to provide
onsite, or have a robust referral linkage with, comprehensive primary
health services does not move Title X outside of its scope of services.
Instead, the final rule makes it easier to ensure that Title X clients,
particularly low income clients, have access to necessary medical
services and related educational and nondirective counseling services;
that screening, diagnosis, and treatment can be provided within close
proximity to the clinic; and that the most needy have access to care.
5. Title X Transparency (42 CFR 59.5(a)(13)
Summary of changes: The proposed rule proposed to add Sec.
59.5(a)(13), to require that projects ``[e]nsure transparency in the
delivery of services'' by reporting certain information ``in grant
applications and all required reports.'' It then outlined three types
of information that would be reported: ``(i) Subrecipients and referral
agencies and individuals by name, location, expertise and services
provided or to be provided; (ii) Detailed description of the extent of
the collaboration with subrecipients, referral agencies and
individuals, as well as less formal partners within the community, in
order to demonstrate a seamless continuum of care for clients; and
(iii) Clear explanation of how the grantee will ensure adequate
oversight and accountability for quality and effectiveness of outcomes
among subrecipients and those who serve as referrals for ancillary or
core services.''
The Department adopts this provision in the final rule with four
changes. First, in Sec. 59.5(a)(13)(i), the Department replaces
``referral agencies'' with simply ``agencies'' who are ``providing
referral services''. Second, the Department removes the phrase ``as
well as less formal partners within the community'' from Sec.
59.5(a)(13)(ii) and replaces it with any individuals ``providing
referral services''. Third, the Department removes the phrase ``and
those who serve as referrals for ancillary or core services'' from
Sec. 59.5(a)(13)(iii). Fourth, the Department makes stylistic changes
to improve clarity.
Comments: Many commenters contend the transparency requirements
would add administrative burden and costs to projects, stating that
programs lack familiarity with policies, referral practices, or
services offered by their subrecipients. Some commenters contend that
these requirements will discourage qualified entities from applying for
Title X grants and will put Title X grantees, in particular programs
with larger referral networks, in the overly burdensome position of
providing oversight for programs that provide non-Title X services. One
commenter suggests that this rule would limit grantees' referral
networks and clients' health care choices and would pose a special
burden to larger grantees. Many commenters state the new reporting
requirements for grantees would take time away from staff who might
otherwise be engaged in patient care. Commenters also state that the
Department already has a level of transparency in place, complete with
access to subrecipient information, and that the proposed language
creates a disincentivized and burdensome outcome for providers to
continue collaborations.
The Department also received comments on whether and how to include
referral agencies in these requirements. One commenter states that the
Department should require documentation from referral agencies to
ensure that referrals are not used to promote abortion. Other
commenters state that the referral agencies, which receive no Title X
funding, should not be subject to these reporting requirements.
Some commenters state that the regulatory text is unclear and
inconsistent, and fails to provide sufficient notice of obligations
under the rule. They point out that it does not define ``less formal
partners'' and does not express a distinction between ``ancillary'' and
``core'' services. They contend the rule unreasonably assumes an
individual physician would know the myriad revenue streams that a large
system receives.
Response: The Department disagrees that the rule will impose an
inappropriate administrative burden or cost on projects. The reporting
requirements would expand transparency surrounding Title X services.
The proposed rule would require applicants to provide certain
information in their applications, required reports, and in response to
performance measures. The information required would include the name,
location, expertise and services provided or to be provided by the
subrecipient/referral agency/individual; a detailed description of the
extent of the collaboration with subrecipient/referral agency, in order
to demonstrate a seamless continuum of care for clients; and a clear
explanation of how the grantee will ensure adequate oversight of, and
accountability for quality and effectiveness of outcomes by,
subrecipients. This information is necessary to ensure that Title X
projects are achieving the goals of the program and expending grant
funds properly.
The Department also disagrees with the suggestion that the
transparency requirements disincentivize collaborations. The fact that
grantees need to describe subrecipient and agencies or individuals
providing referral services by name, location, expertise and services
provided or to be provided does not deter those collaborations.
Grantees should already know the details of those collaborations if
they are important to the success of their projects. Understanding and
being able to describe the details of collaborations is important to
ensure the collaborations help the project achieve the goals of the
program and comply with all applicable program requirements.
The Department appreciates the responses to its request for comment
specifically on whether a referral agency should be subject to the same
reporting requirements as a grantee and/or
[[Page 7751]]
subrecipient.\83\ After carefully considering the comments on this
issue, the Department concludes that the regulations should apply
differently to referral agencies than to subrecipients of funding. A
subrecipient ``provides family planning services with Title X funds
under a written agreement with a grantee or another subrecipient.'' As
such, the subrecipient functions as a part of the Title X program in
providing preconception family planning services. Referral agencies do
not receive Title X funds to provide Title X services. The Department,
thus, has concluded it will not use these rules to hold referral
agencies to the same requirements that are expected of grantee and
subrecipient entities. Grantees and subrecipients must provide certain
information regarding their referral network, as described elsewhere in
this rule, but since referral entities do not receive Title X funding,
they are not required to comply with the requirements of this final
rule.
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\83\ The Department proposed to define ``subrecipient'' as ``any
entity that provides family planning services with Title X funds
under a written agreement with a grantee or another subrecipient.
These subrecipients have entered into binding agreements or other
financial relationships with Title X grantees to provide Title X
services in a given State or community. A ``[s]ubrecipient'' may
also be referred to as a ``delegate'' or ``contract agency.'' These
entities receive Title X funds to provide Title X services, and are
subject to the Title X statute and regulations.
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The Department also concurs that the phrase ``ancillary or core
services'' may not have been clear. Therefore, the Department does not
include the phrase ``and those who serve as referrals for ancillary or
core services'' in Sec. 59.5(a)(13)(iii) of the final rule. The
Department also agrees with commenters who say it is difficult to
understand what is meant by ``less formal partners.'' The Department
believes it is sufficient to include subrecipients and referral
agencies and individuals in the explanation of collaborations, so the
phrase ``as well as less formal partners within the community'' will
likewise not be included in Sec. 59.5(a)(13)(ii) of the final rule.
6. Encouragement of Family Participation (42 CFR 59.5(a)(14))
Summary of changes: The proposed rule would add Sec. 59.5(a)(14),
a new requirement that projects ``[e]ncourage family participation in
the decision of minors to seek family planning services and ensure that
the records maintained with respect to each minor document the specific
actions taken to encourage such family participation (or the specific
reason why such family participation was not encouraged).'' The
Department adopts this language with changes to clarify that family
participation is encouraged for all patients, including, but not
exclusive of, minors in the final rule.
Comments: Many commenters express concern that this language
undermines patient confidentiality and access to care by placing
increased pressure on adolescent patients to involve their family, and
may possibly cause patients to avoid seeking care. Many commenters
state this requirement creates barriers for young people to obtain care
by imposing several new, but in their opinion, antiquated requirements
on providing care to minors, especially through screening the
adolescents for STDs or pregnancy.
Many commenters express concern that providers will be confused
about their obligations. They assert this requirement is not responsive
to the CDC/OPA Quality Care Guidelines, and state that it runs afoul of
the Title X regulations that require providing services in a manner
that protects patients dignity and ensures patient choices are entirely
voluntary. Many commenters suggest that involving family members is not
always advisable or realistic, and could cause conflict with some State
statues or regulations that allow minors to make decisions about their
health care, including contraception. One such commenter suggests that
this paragraph be stricken or at least clarified further.
Many commenters feel that clinicians should not be required to take
specific actions to document attempts to involve family members, as
this would undermine patient-provider relationships and is unnecessary
and excessively burdensome. Alternatively, commenters recommend that
the efforts and funds from Title X programs would be better used to
support training for providers on the best methods to encourage family
involvement consistent with minor patient's confidentiality rights,
health needs, and best interests.
Some commenters support the language requiring, and documenting,
the encouragement of family participation, saying it is an appropriate
clarification of the Congressional mandate for the program. Several
commenters state that the requirement is consistent with the statutes
and Supreme Court jurisprudence on parental rights. One commenter
states that the encouragement of family participation and other
reporting requirements provide an appropriate layer of protection for
children to ensure Title X agencies are considering circumstances in
which minors may be suffering abuse. One commenter states that the
language does not have a chilling effect on access to Title X health
services. Other commenters commend the Department's proposed language
and suggest that encouraging parental involvement should always be the
standard for any health care services provided to a minor.
Response: The Department realizes that the Title X statute is clear
that family participation should be encouraged for all patients who
access family planning services, and not merely minors. Congress
requires that ``[t]o the extent practical, entities which receive
grants or contracts under this subsection shall encourage familiy [sic]
participation in projects assisted under this subsection.'' 42 U.S.C.
300(a). However, pursuant to annual appropriations provisions, Congress
directs additional specific requirements with respect to the
encouragement of family participation in the decisions of minors to
seek family planning services: ``None of the funds appropriated in this
Act may be made available to any entity under title X of the PHS Act
unless the applicant for the award certifies to the Secretary that it
encourages family participation in the decision of minors to seek
family planning services . . . .'' \84\ To ensure compliance with these
requirements, the final rule requires Title X service providers to
encourage family participation in the decision of minors and others to
seek family planning services. It also requires providers to document,
in the records maintained with respect to each minor patient, the
specific actions taken to encourage such family participation (or the
specific reason why such family participation was not encouraged).\85\
The Department believes that the rule clarifies the steps the Title X
providers must take, consistent with governing law, to encourage family
participation, especially with respect to minors.
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\84\ HHS Appropriations Act 2019, Public Law 115-245, Div. B,
sec. 207, 132 Stat. at 3090.
\85\ As noted below, suspecting child abuse, child molestation,
incest, or the like and reporting it to the appropriate authorities,
consistent with State or local reporting or notification laws, would
constitute a good reason not to encourage family participation.
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The Department disagrees that the rule causes conflict with State
statutes and other Title X regulations. As noted above, the rule
specifically implements several federal statutory requirements by
requiring encouragement of family participation in family planning
decisions while making allowance for instances where such encouragement
would not be appropriate. Requiring
[[Page 7752]]
Title X projects to encourage family participation in the decision of
unemancipated minors to seek family planning services does not require,
and is not the equivalent of, parental notification or family
participation. Rather, the ordinary meaning of Congress's requirement
would be for a provider to converse with a minor (or other) patient in
the course of care, and in an appropriate way, encourage family
participation in the patient's consideration of family planning methods
and services. This requirement is consistent with the ordinary
understanding that communication between health care providers and
patients is essential to providing quality and effective care. Congress
is not required to fund projects where minors (or other patients) are
given subsidized family planning but not encouraged to involve their
families in their family planning decisions. To the extent that there
is conflict between the Title X statutory (and regulatory) requirements
and any requirements of State law, the federal requirements would apply
to the recipients (and subrecipients) of Title X funds.
The Department understands some commenters' concerns about the need
to maintain patient confidentiality. The Department agrees that Title X
providers must continue to comply with laws concerning patient
confidentiality, including those specifically pertaining to the
confidentiality of minors with respect to Title X services. Health care
providers already have conversations with their patients and document
those discussions in patient records, while maintaining patient
confidentiality. More broadly, such health care providers in the Title
X program are also already required to encourage family participation
where practical by the statutory directives adopted by Congress. This
provision merely implements that requirement. With respect to minors,
the Department believes that Title X projects and participating
entities can comply with the rule's requirement to encourage family
participation and to document such encouragement, or to note the reason
why that was not appropriate, without infringing on patient
confidentiality.
To those commenters who contend that encouraging family
participation imposes barriers to the care of minors, the Department
would point out that Congress made a different judgment. Congress
requires that, ``[t]o the extent practical'', Title X grantees ``shall
encourage familiy [sic] participation in projects assisted under this
subsection.'' 42 U.S.C. 300(a). Similarly, specifically with respect to
minors, Congress has made it a condition of funding that an applicant
for a Title X award ``certifies to the Secretary that it encourages
family participation in the decision of minors to seek family planning
services.'' HHS Appropriations Act 2019, Public Law 115-245, Div. B,
sec. 207, 132 Stat. at 3090; Consolidated Appropriations Act 2018,
Public Law 115-141, Div. H, sec. 207, 132 Stat. 348, 736. Congress
clearly did not anticipate a meaningful barrier when it enacted these
requirements. Moreover, encouraging family participation is not the
same as requiring family participation. The rule also allows
appropriate discretion for health care professionals with respect to
the requirement to encourage family participation where, for example,
family participation may present a serious risk to the minor, such as
when child abuse or incest is suspected. The rule simply requires Title
X providers to document, in the patient's records, the reasons why
family participation was not encouraged and, consistent with applicable
local law, to report any suspected abuse to the relevant authorities.
The Department disagrees with those who contend the rule may
compromise the provision of patient-centered care or the protection of
the patient's dignity. The Department believes that involving parents
in general, and in family planning decision-making in particular, can
improve behavioral consistency with health recommendations for an
adolescent. There is evidence that parent-child communication about
family planning decisions increases the likelihood that the adolescent
will consistently make healthier choices.\86\
---------------------------------------------------------------------------
\86\ Patricia Dittus et al., Parental Monitoring and Its
Associations with Adolescent Sexual Risk Behavior: A Meta-analysis,
136 Pediatrics e1587-99 (2015).
Tianji Cai et al., The School Contextual Effect of Sexual Debut
on Sexual Risk-Taking: A Joint Parameter Approach, J Sch Health.
2018; 88: 200-207 (2018). library.nih.gov/pubmed/29gov.ezproxyhhs.nihlibrary.nih.gov/pubmed/29399838 or https://www.ncbi.nlm.nih.gov/pubmed/29399838.
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For all these reasons, the Department considers it appropriate to
finalize the proposed rule concerning encouragement of family
participation, with the clarification noted above.
7. Provide for Medically Necessary Services (42 CFR 59.5(b)(1))
Summary of changes: The proposed rule would amend Sec. 59.5(b)(1)
to require that any referrals to other medical facilities be made
consistent with Sec. 59.14(a), which would bar referral for abortion
as a method of family planning. The department finalizes 42 CFR
59.5(b)(1) with stylistic changes and to change the phrase ``when
medically indicated'' to ``when medically necessary.'' The finalized
provision requires Title X projects to:
Provide for medical services related to family planning (including
physician's consultation, examination, prescription, and continuing
supervision, laboratory examination, contraceptive supplies) and
referral to other medical facilities when medically necessary,
consistent with Sec. 59.14(a), and provide for the effective usage of
contraceptive devices and practices.
All comments concerning this section are addressed in the section
of this preamble that discusses new Sec. 59.14(a).
8. Provide for Coordination and Referral, Consistent With Prohibition
on Referral for Abortion (42 CFR 59.5(b)(1))
Summary of changes: The 2000 regulations state that projects must
``[p]rovide for coordination and use of referral arrangements with
other providers of health care services, local health and welfare
departments, hospitals, voluntary agencies, and health services
projects supported by other federal programs.'' The proposed rule would
amend this provision by requiring that any referrals be consistent with
Sec. 59.14(a), which would bar referral for abortion as a method of
family planning.
The Department's discussion of and response to other comments
relevant to this language are incorporated in the section of the
preamble discussing proposed Sec. 59.14(a).\87\
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\87\ As discussed above, in Sec. 59.5(a)(12) the Department is
finalizing requirements concerning the relationship between Title X
service providers and comprehensive primary health services. The
Department is also maintaining the requirement for coordination and
use of referral arrangements in in Sec. 59.5(b)(8), but qualifying
that requirement with the more specific requirements set forth in in
Sec. 59.14(a).
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The Department finalizes this language without change, except for
corrections in punctuation.
F. Criteria for Selection of Grantees (42 CFR 59.7)
Summary of changes: At Sec. 59.7 of the proposed rule, the
Department proposed to revise the criteria for the selection of
grantees set forth in the 2000 regulations. The 2000 regulations set
forth seven criteria for the Department to take into account, including
the four criteria established in PHS Act section 1001(b). Those four
criteria are included in the 2000 regulations and are similar to the
PHS Act wording: (1) ``The number of patients to be served, and, in
particular, the number of low-income patients,'' (2) ``the extent to
which
[[Page 7753]]
family planning services are needed locally,'' (3) ``the relative need
of the applicant,'' and (4) an applicant's ``capacity to make rapid and
effective use of such assistance.'' The 2000 regulations also added
three additional criteria not listed in the PHS Act: (5) The ``adequacy
of the applicant's facilities and staff,'' (6) the ``relative
availability of non-federal resources within the community to be served
and the degree to which those resources are committed to the project,''
and a catch-all criterion considering (7) ``the degree to which the
project plan adequately provides for the requirements set forth in
these regulations.'' The proposed rule would restructure these
requirements into five parts: first, in paragraph (b), a consideration
of whether the applicant proposes to satisfy the requirements set forth
in the regulations, and then, in paragraph (c), the four criteria set
forth in section 1001(b), elaborating on each one to indicate how the
Department would implement them. The proposed rule would delete the
remaining two paragraphs of the 2000 regulations discussing cost
allocations for projects as determined by the Secretary.
The Department finalizes this section with changes in Sec.
59.7(c)(2) to address concerns raised by certain comments regarding an
applicant's ability to procure a broad range of diverse subrecipients.
In the final rule, the Department also retains Sec. 59.7(b) and (c) of
the 2000 regulations, which the proposed rule would have deleted, but
redesignates them as Sec. 59.7(d) and (e). Finally, several stylistic
changes are made to improve clarity and readability of the application
review criteria.
Comments: Several commenters state the rule significantly alters
the existing program grant review criteria, undermining the usefulness
of the criteria for the purpose of differentiating the best
applications and best uses of Title X funds. Some commenters state that
the new, shorter list of criteria contributes to greater Department
leeway in making decisions about awards that do not focus on the
effectiveness of the family planning care. One commenter contends that
the new criteria will limit the number of qualified and experienced
health care providers who can compete for funding. One commenter states
the Department provides no justification or rationale for the
requirement for new and inexperienced partners. The commenter laments
that the wording of the rule appears to require projects to partner
with new organizations each year--an unworkable proposition because the
pool of new providers is limited.
Some commenters state the rule will unconstitutionally give an
advantage to religious groups due to the second factor of the grant
review process criteria stating that preference will be given
``especially among a broad range of partners and diverse subrecipients
and referral individuals and organizations, and among non-traditional
Title X partnering organizations.'' Some of these commenters express
concern that the ``diverse'' and ``non-traditional'' organizations the
Department is referring to are faith-based providers or religious
entities that oppose abortion and some or all forms of contraception.
The commenters state that these organizations have been previously
ineligible to receive Title X funds but would now be eligible under the
new criteria. One commenter argues the rule provides no evidence
supporting the idea that there are many ``non-traditional''
organizations and different kinds of new subrecipients that could cycle
into Title X projects and improve low income patients' access to high-
quality family planning services.
Some commenters state the rule will not increase competition and
rigor among applicants, encourage broader and more diverse applicants,
or better ensure quality applicants are selected. Rather, they contend
the rule will curtail the current wide reach of Title X by allowing
funding to organizations that do not provide comprehensive pregnancy
counseling. A few commenters state that there was no evidence that a
change in the application review process or additional diversity among
applicants is necessary.
Some commenters note that the existing network of Title X primary
grantees and subrecipients has been relatively stable over time and has
developed deep expertise and experience in family planning that
profoundly benefits the communities they serve. They believe the rule
will jeopardize the existence of well-developed, proven-effective
programs that are based on the best clinical standards, scientific
evidence, and care. One commenter asserts that, although the Department
states there will be increased competition for funding, the changes set
forth in the proposed rule will only change the types of entities
applying for these funds, inviting organizations to apply that have no
interest in fulfilling the statutory program mandate to provide a broad
range of effective family planning methods and services.
Some commenters express concern regarding how much weight will be
allocated to each criterion, and whether preferences may be established
for Title X projects that do not provide a full scope of scientific,
medically based care, citing providers of natural family planning and
other fertility awareness-based methods. One commenter expresses a
belief that sites providing abortion services will be disqualified and
other sites that offer natural family planning and fertility awareness-
based methods will be preferred.
One commenter supporting the proposed rule describes the process
for evaluating applicants as thorough, and is in favor of requiring
applicants to demonstrate their ability to comply with regulations,
especially in terms of separation of funds and transparency of
activity. The commenter adds that this requirement likely would reduce
the potential for misuse of funds. One commenter argues grant
applicants should be required to provide written assent to all relevant
statutory and regulatory requirements, and should submit all relevant
organizational documents, such as personnel manuals, client guidelines
and protocols, in order to demonstrate that the organization has a
pervasive policy framework and organizational culture consistent with
the law and the final rule.
Several commenters state the Department will have unchecked
discretion to prevent applications from reaching the objective review
process that now governs the awarding of grants, putting the Department
in complete unfettered control of which applications will be a part of
the objective review process. Such commenters state that, historically,
the process has hinged on the evaluation of objective review panels,
but the new assessment would be subjective and non-transparent, and
would give the Department discretion to block any applicant from
reaching the competitive review process, perhaps for political
purposes. Several commenters state the criteria are unclear and vague,
and ask the Department to specifically and clearly state the criteria
with which it will review applicants before they reach the objective
panel review. One commenter contends the Department is bypassing the
regulatory process to add new criteria, and says the rule will include
a subjective standard without oversight.
A few commenters state that, in applying these criteria
retroactively to grantees with current grants at the time the final
rule goes into effect, the rule would undermine the fairness of the
funding opportunity announcement (FOA) and thwart the award process in
which applicants were scored on criteria about which they were aware at
the time of their applications. The commenters contend that imposition
of
[[Page 7754]]
these measures well after the application due date of the previous FOA
would create a fundamentally unfair scoring process with respect to
that FOA and would unjustly provide funding to organizations not
capable of providing the full range of comprehensive services that has
long been the benchmark of Title X care.
Response: The Department generally agrees with commenters who
support the proposed language of Sec. 59.7 as providing a thorough
process to ensure applicants demonstrate their ability to comply with
regulations and avoid misuse of funds.
Proposed Sec. 59.7(b) would require Title X applicants to clearly
address how their proposal will satisfy the requirements of this
regulation, in order to proceed to the competitive grant review
process. As a result of confusion by some commenters, the Department
provides additional clarity with further detail related to the
requirements for compliance with this initial screening. An applicant
would be required to describe its plans for affirmative compliance with
each requirement of the Title X regulations, as explicitly defined by
the Department in the funding announcement. For example, this would
include not only demonstrating physical and financial separation from
abortion as a method of family planning (when compliance with such
requirement becomes required), but also explaining how the applicant
will provide a broad range of acceptable and effective family planning
methods and services. The funding announcement will clearly describe
how applicants should address this requirement, including any
documentation that is necessary to demonstrate affirmative compliance
with each of the regulation requirements. The Department will implement
these requirements to better direct Title X funds for family planning
projects, to prevent misuse of funds, and to save taxpayer dollars by
only sending qualified applications to the costly and time consuming
competitive review committee. Once the applicant successfully
demonstrates affirmative compliance with the Title X regulations (a
yes/no issue), the Department will consider each applicant
competitively according to the criteria set forth in the regulation.
In response to a commenter suggesting that applicants be required
to submit additional documentation such as personnel guidelines and
documents regarding the organizational structure of applicants, the
Department agrees that submission of such documents may be included to
support an application, but will not require it. The Department
concludes that such a requirement may be overly burdensome. Applicants
will be required to demonstrate they will achieve the goals of the
program and meet the statutory and regulatory criteria, but the
Department declines to add the additional documentation requirements
suggested by the commenter.
The Department acknowledges the confusion expressed by commenters
on the meaning of the phrase ``a broad range of partners and diverse
subrecipients and referral individuals and organizations, and among
non-traditional Title X partnering organizations'' in Sec. 59.7(c)(2)
of the proposed rule. Although most such commenters objected to the
need for new partners, the Department notes that it does not intend
that grant funds be designated to referral individuals or referral
organizations, since such referrals are made without any monetary
exchange. Grant funds would only be provided to ``non-traditional Title
X partnering organizations'' if they are subrecipients in a Title X
project. The Department further clarifies that it does not intend that
grantees must change subrecipient relationships each year, but that
grantees make ongoing efforts to expand the network of partners
throughout the service area, especially with respect to nontraditional
partnering organizations. The Department additionally clarifies that it
does not expect grantees who plan to provide all family planning
services themselves, to now designate that these services be provided
by subrecipients. The Department wishes to spur innovation and more
extensive service, but does not wish to limit grantees' flexibility.
However, if grantees implement a model in which they partner with
subrecipients for services, the Department wants to emphasize that a
broad range of subrecipients be partners, including those who are
nontraditional organizations, but this does not necessarily mean that
such subrecipients will be new providers in the Title X program.
Finally, the Department adds the phrase ``as applicable'' following the
``broad range of diverse subrecipients in recognition of and to allow
for grantees, such as community health centers, who may choose to
directly provide services and not use any subrecipients. To clarify
this provision and resolve the concerns of many commenters, the
Department modifies the language of Sec. 59.7(c)(2) in the final rule
to read as follows: ``The degree to which the relative need of the
applicant for federal funds is demonstrated in the proposal, and the
applicant shows capacity to make rapid and effective use of grant
funds, including its ability to procure a broad range of diverse
subrecipients, as applicable, in order to expand family planning
services available to patients in the project area.''
The Department rejects the claim by some commenters that the
criteria set forth in the rule gives an unconstitutional advantage to
religious groups. Neither the proposed language, nor the language of
the final rule (including Sec. 59.7(c)(2)), mentions religious groups
nor expresses a preference in favor of them. The Department's focus in
implementing Title X is on providing and expanding the provision of
services to low income, unserved or underserved patients in a timely
manner. The Department welcomes applications from faith-based
organizations as well as secular non-profit entities. With respect to
the criteria in Sec. 59.7(c)(2), the Department would favor those
applicants that can meet the needs of patients, especially those who
are unserved and underserved, seeking family planning services, while
complying with the statutory and regulatory requirements of the Title X
program. The Department encourages Title X applicants to develop
innovative strategies to meet the family planning needs of the various
populations in their proposed service areas. Diversity in the range of
partners included in applicants' proposals is but one factor among many
that the Department will consider in reviewing applications.
The Department disagrees with commenters who contend the criteria
in Sec. 59.7 will diminish the program's effectiveness. Rather, these
criteria will assist the Department in ensuring that the statutory
requirements of the Title X program are met, the program is serving
patients as Congress intended, gaps in services (or populations served)
are closed, and providers are free to explore and test new ways to
better provide service to patients.
The Department similarly disagrees with commenters who fear the
rule, and the review criteria in particular, will exclude some
applicants, especially those who provide abortion or those who have
long experience with the program. No provision in Title X or in the
proposed or final rule prevents abortion-providing organizations from
applying for, and receiving, Title X funding, so long as the
organization meets this rule's requirements with respect to the
proposed Title X project, including physical and financial separation,
and not providing,
[[Page 7755]]
promoting, or referring for abortion as a method of family planning in
the Title X project. Nothing in Sec. 59.7 excludes experienced Title X
providers from continuing to compete on a level playing field for Title
X funds. In fact, some review criteria might be more easily met by
applicants with experienced and established networks. The Department
intends for all funded applicants, both new and those who are
experienced Title X providers, to improve or expand the quality and
scope of overall service to clients, as a result of following the
criteria set forth in these final rules.
The Department also disputes the assertion by some commenters that
an emphasis will be placed on natural family planning over other
methods. In the final rule at Sec. 59.7(c)(1), the Department clearly
and specifically requires every Title X project to provide a ``broad
range of acceptable and effective family planning methods and services
(including natural family planning methods, infertility services, and
services for adolescents).'' The Department emphasizes that Section
1001 of the Title X statute includes natural family planning in its
non-exclusive list of family planning methods and services. See 42
U.S.C. 300(a). The Department's definition of family planning
recognizes the broad range of statutorily acceptable services by
``including contraceptive methods, and natural family planning or other
fertility awareness-based methods.'' Accordingly, nothing in the
criteria set forth in Sec. 59.7 expresses a preference for applicants
that offer natural family planning or other fertility awareness-based
methods methods--they simply require each project to offer both
contraceptives and natural family planning or other fertility-awareness
based methods.
Consistent with the Department's historic processes, the weight
attached to each criterion is not established in this rule. This is not
only consistent with how the Department has operated, but also with the
process of most other grant funding programs. The Department reserves
the discretion to set forth more specific weights for each criterion in
funding opportunity announcements.
The Department has not given itself unchecked discretion to
disqualify applications in this rule. First, the Department is bound to
maintain the integrity of the program and to implement the program in
such a manner as to ensure compliance with statutory requirements. All
provisions in this rule seek to achieve that purpose. The 2000
regulations afforded the Department significant flexibility in
determining criteria for awards. In the revised version of Sec. 59.7,
paragraph (b) sets forth an overarching requirement that each applicant
clearly address how the proposal will satisfy the requirements of the
regulations and describe the applicant's plans for affirmative
compliance. That paragraph, far from giving the Department
unconstrained discretion, ensures that projects will comply with the
provisions of the applicable statutes (which are embodied in the
regulation) and the regulations themselves. It also increases the
efficiency of the review process by only expending Department resources
for the competitive review panel to review applications that meet the
minimum requirements for the program.
Second, paragraph (c) of Sec. 59.7, as revised, does not set forth
any novel flexibility or discretion not already provided by the Title X
statute and available under the Title X regulations. The 2000
regulations, like section 1001(b) of Title X, simply state the
Department shall ``take into account'' those factors. The statutory
list of factors is not exclusive. And the Department has periodically
described, in funding opportunity announcements and its grants policy,
other criteria applicable to proposals, paying due attention to
consistency with the Title X statute and regulations. Section 59.7(c)
of this final rule states that applicants ``will be subject'' to those
criteria, again leaving the Department some discretion to describe
additional criteria. But in all events, the Department recognizes that
such criteria must be consistent with any applicable statutes and
regulations. And here, the new regulatory criteria are consistent with
the requirements set forth in the Title X statute.
Third, as is true throughout the Department, Title X grants are
awarded through a merit-based grantmaking process consistent with the
Department's grants policy, and in accordance with the Executive
Branch's Uniform Administrative Requirements and the Department's own
grants regulations. In this competitive process, eligible applications
are reviewed by a panel of independent reviewers and evaluated based in
part on criteria in the Title X program regulations, and published in
the funding opportunity announcement. In addition to the independent
review panel, Federal staff review each application for programmatic,
budgetary, and grants management compliance. Finally, applications
recommended for funding are evaluated, in accordance with 45 CFR
75.205, for risks before an award is issued.\88\
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\88\ 45 CFR 75.204 (``HHS funding agency review of merit of
proposals'', provides that ``[f]or competitive grants or cooperative
agreements, unless prohibited by Federal statute, the HHS awarding
agency must design and execute a merit review process for
applications. This process must be described or incorporated by
reference in the applicable funding opportunity (see appendix I to
this part.) See also Sec. 75.203.'')
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The Department does not agree with commenters that it will assert
unchecked discretion to arbitrarily dismiss applications before
reaching the independent review panel. For example, as stated in
paragraph (b) of the final rule, the Department has committed to
``explicitly summarize each requirement of the Title X regulations . .
.'' or provide the entire regulation with which the applicant must
demonstrate compliance, and has explained that applicants must
``describe its plans for affirmative compliance with each
requirement.'' These requirements, which focus on regulatory provisions
with which grantees must comply, provide meaningful parameters to the
Department's discretion. Failure by an applicant to clearly demonstrate
compliance with Title X regulations would constitute a fatal flaw to an
application for Title X funds.
The Department also notes that broad discretion is granted to it by
the Title X statute when selecting between potential grantees. The 2000
regulations acknowledged this discretion when they stated that ``the
Secretary may award grants for the establishment and operation of those
projects which will in the Department's judgment best promote the
purposes of Section 1001.'' 42 CFR 59.7(a). Requiring applicants to
establish compliance with Title X regulatory provisions is important to
providing the Department with an informed baseline for exercising this
discretion. As noted above, these regulatory provisions ensure
compliance with the statutory framework and, thus, provide useful
information for assessing applications both before and within the
competitive grant review process. The Department believes that
receiving this information will enable the Department to more
efficiently and effectively review the significant number of
applications for Title X funding, as well as provide important
information to the independent review panel. Accordingly, the
Department finds that the final rule reflects a proper and effective
exercise of the Department's grant discretion bound by the statutory
and regulatory text.
[[Page 7756]]
In sum, the Department believes the final rule functionally and
appropriately limits the Department's discretion by requiring that
applicants be subject to the criteria set forth in Sec. 59.7(c), and
that the discretion the Department retains under Sec. 59.7 to consider
other factors is not fundamentally different from the non-exclusive
lists of factors set forth in the 2000 regulations. The Department
believes that this final rule will help ensure reliability and
certainty in the grant selection process, while maintaining an open
process similar to the selection process for other grants at the
Department. In pursuing these ends, the Department continues to focus
on ensuring compliance with the statutory Title X requirements,\89\
including the program integrity provisions referenced throughout this
preamble; expanding the type and nature of the Title X providers and
ensuring the diversity of such providers so as to fill gaps and expand
family planning services offered through Title X; and using review
criteria as a meaningful instrument to assess the quality of the
applicant and the application. The Department believes that these
goals, which are consistent with the Title X statute and similar to the
approach taken in the 2000 regulations, are best achieved by finalizing
Sec. 59.7 as set forth in this final rule.
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\89\ See 42 U.S.C. 300-300a-6; HHS Appropriations Act 2019,
Public Law 115-245, Div. B, secs. 207-208 132 Stat. at 3090.
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In response to a commenter who requests that an additional
criterion be added to Sec. 59.7(c) to consider whether there is a
family planning gap in the community, the Department appreciates the
concern. But, as part of the final rule, Sec. 59.7(c)(4) already
states the Department will consider ``[t]he extent to which family
planning services are needed locally. . .'' and whether the applicant
proposes innovative ways to provide services to unserved or underserved
patients. The Department believes that the community's need--including
any family planning gaps in the community--is already adequately
addressed in that criterion. Furthermore, in response to comments cited
earlier that emphasize the value of Title X as the sole federal program
dedicated to funding family planning services for low income
individuals, the Department adds a reference to low-income patients to
the criterion in Sec. 59.7(c)(3) in order to accentuate the obligation
of Title X projects to serve low-income patients and populations.
The Department agrees with the concerns of commenters who ask that
the application criteria not be effective with regard to a FOA that has
already been published, and where applications have already come due,
prior to the effective date of this final rule. The Department agrees
that applicants should know the criteria on which review of their
applications will be based. Therefore, the Department will establish
compliance dates for these provisions so that Sec. 59.7 and the
criteria set forth therein will be applied only to future FOAs issued
after the effective date of this final rule, consistent with the
effective dates and compliance dates established in this final rule. To
the extent these criteria are relevant to applications for continuation
awards under previously awarded grants, Sec. 59.7 will also apply if
those continuation award applications are due after the effective/
compliance date, i.e., more than 60 days after the publication date of
the final rule. As discussed below, the Department is establishing
compliance dates for other provisions of the final rule in the
transition provision, Sec. 59.19, so language clarifying the
compliance date for Sec. 59.7 is set forth in that provision.
The proposed rule would have deleted current Sec. 59.7(b) and (c)
from the Title X regulations. These provisions concern the amount of an
award with respect to a project's estimated costs. The Department did
not receive comments concerning the proposal to delete these
paragraphs. Upon further consideration, however, the Department has
determined that it is appropriate to retain these two paragraphs from
the 2000 regulations. In section 1006(a), Title X provides that, while
the Secretary shall determine the amount of any grant, no grant may
generally be made for less than 90% of its costs. The Department
believes that these current provisions in the Title X regulations--
which reiterates this requirement and provides that no grant may be
made for an amount equal to 100% of the project's estimated costs--
express statutory requirements for the Title X program. The Department
believes explicitly maintaining these statutory parameters in the Title
X regulations provide helpful clarity for Title X grantees. Therefore,
the Department is not finalizing the proposal to delete these two
paragraphs from the 2000 rule, and this final rule will retain the
paragraphs, redesignated as paragraphs (d) and (e).
G. Confidentiality (42 CFR 59.11)
Summary of changes: The 2000 regulations required that all
information obtained by project staff about individuals must be held
confidential and not disclosed without the individual's documented
consent, with limited exceptions required by law. The proposed rule, at
Sec. [thinsp]59.11, would clarify that confidentiality concerns cannot
be the basis for failure to comply with legal requirements to report or
provide notice of certain criminal activity. With the proposed
amendment, section 59.11 would specify that ``[a]ll information as to
personal facts and circumstances obtained by the project staff about
individuals receiving services must be held confidential and not be
disclosed without the individual's documented consent, except as may be
necessary to provide services to the patient or as required by law,
with appropriate safeguards for confidentiality; concern with respect
to the confidentiality of information, however, may not be used as a
rationale for noncompliance with laws requiring notification or
reporting of child abuse, child molestation, sexual abuse, rape,
incest, intimate partner violence, human trafficking, or similar
reporting laws. Otherwise, information may be disclosed only in
summary, statistical, or other form which does not identify particular
individuals.''
The Department adopts the modification to this section without
change, except for corrections in punctuation.
Comments: Many commenters assert that medical professionals are
deeply committed to protecting patients who may be victims of abuse or
other criminal activity, and their commitment is reflected in their
ongoing compliance with State and local reporting laws. Commenters
emphasize the importance of confidentiality in the care of adolescents,
with commenters characterizing Title X providers as access points for
youth autonomy. Commenters argue that, without assurances of
confidentiality, young people would not seek family planning services.
They contend that the proposed changes to confidentiality protections
would hinder access to contraception and information for young people,
both of which have contributed to lower instances of teen pregnancy.
Response: The Department agrees with commenters who stress that
Title X providers must continue to comply with laws concerning patient
confidentiality, including those specifically pertaining to the
confidentiality for minors with respect to Title X services. For this
reason, the Department does not change the current regulatory provision
that requires that all information as to personal facts and
circumstances obtained by the project staff about individuals receiving
services must be held confidential and
[[Page 7757]]
not be disclosed without the individual's documented consent, except as
necessary to provide services to the patient or as required by law,
with appropriate safeguards for confidentiality. The Department also
does not change the further specification in the rule that, in any
other case, information may be disclosed only in summary, statistical,
or other form which does not identify particular individuals. The rule
will, thus, continue to protect the confidentiality of patient
information subject to these well-established exceptions and
limitations. The only change is to clarify that the concerns for
``appropriate safeguards for confidentiality'' may not be used as a
rationale for noncompliance with State or local laws requiring
notification or reporting of child abuse, child molestation, sexual
abuse, rape, incest, intimate partner violence, human trafficking, or
similar criminal activity.
The Department believes the final rule is consistent with standard
health care confidentiality practices, in which providers already have
conversations with their patients, document those discussions in
patient records, and comply with State and local reporting
requirements, while otherwise maintaining the confidentiality of that
information. Although the Department understands the challenge of
balancing protection for victims, complying with State reporting laws,
and maintaining trust in the patient-provider relationship, the
Department's annual appropriations law requires that Title X projects
comply with such State reporting requirements. Moreover, the Department
believes that Title X programs can best serve minors and other
vulnerable populations by ensuring Title X providers have a plan for
reporting abuse as required by State and local reporting laws. Title X
projects and participating entities can comply with these reporting
requirements and document the measures taken to comply, much as health
care providers do in other contexts, without infringing in any way on
patient confidentiality.
H. Standards of Compliance With Prohibition on Abortion (42 CFR 59.13)
Summary of changes: The proposed rule would add Sec. 59.13, which
would specify that ``[a] project may not receive funds under this
subpart unless it provides assurance satisfactory to the Secretary
that, as a Title X grantee, it does not provide abortion and does not
include abortion as a method of family planning. Such assurance must
also include, at a minimum, representations (supported by documentary
evidence where the Secretary requests it) as to compliance with this
section and each of the requirements in Sec. Sec. [thinsp]59.14
through 59.16. A project supported under this subpart must comply with
such requirements at all times during the project period.''
The Department finalizes this definition with changes in response
to comments that emphasize the grantee's responsibility to provide
satisfactory assurance to the Secretary that the project complies with
the statutory and regulatory Title X requirements.
Comments: One commenter states that the definitions of ``grantee''
and ``project'' are unclear and create confusion. Specifically, the
commenter states that, under Sec. 59.13, ``[a] project may not receive
funds under this subpart unless it provides assurance satisfactory to
the Secretary that, as a Title X grantee, it does not provide abortion
and does not include abortion as a method of family planning.''
Project, however, is defined to ``mean a plan or sequence of activities
that fulfills the requirements elaborated in a Title X funding
announcement and may be comprised of, and implemented by a single
grantee or subrecipient(s), or a group of partnering providers who,
under a grantee or subrecipient, deliver comprehensive family planning
services that satisfy the requirements of the grant within a service
area.'' The commenter contends that Sec. 59.13 treats ``grantee'' and
``project'' interchangeably, and therefore causes confusion, as well as
risking the interpretation that, under Sec. 59.13, the grantee may not
provide abortion or include abortion as a method of family planning
both inside and outside the project. The commenter contends this
ambiguity fails to give applicants a sufficient understanding of how
the rule works, and what conditions apply to applicants for grants.
Commenters also assert that the regulations do not articulate how
compliance should be demonstrated under Sec. 59.13, and what
documentary evidence would be necessary to provide this assurance.
Other commenters raise general concerns discussed elsewhere in this
preamble.
Response: The Department agrees with the commenter that there is a
lack of clarity with respect to the use of the terms ``grantee'' in
Sec. 59.2 and ``project'' in Sec. 59.13. The Department intends the
compliance standards in Sec. 59.13 to apply to a grantee's activities
within a Title X project, not to a grantee's activities outside of a
project. The Department recognizes that an entity that serves as a
Title X grantee may provide abortion or include abortion as a method of
family planning separate from, independent of, and outside, the Title X
project for which the grantee has been selected. Such an entity may
still qualify for a Title X grant, so long as it meets each of the
requirements in Sec. Sec. 59.13 through 59.16 with respect to the
project, including but not limited to the physical and financial
separation, and ensures compliance with those requirements by its
subrecipients with respect to the project. This recognition is
consistent with Rust v. Sullivan \90\ and the 1988 regulations.\91\ The
Department believes that the lack of clarity in the proposed rule was
not due to the definition of ``grantee'' in Sec. 59.2, but the use of
the terms ``grantee'' and ``project'' in Sec. 59.13.
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\90\ 500 U.S. 173.
\91\ 42 CFR 59.1-59.12 (1988 ed.), 53 FR 2922 (Feb. 2, 1988).
---------------------------------------------------------------------------
The Department addresses this confusion by modifying a phrase and
adding further clarity with regard to where responsibility for
compliance lies.\92\ Consequently, the Department finalizes Sec. 59.13
to state: ``A project may not receive funds under this subpart unless
the grantee provides assurance satisfactory to the Secretary that the
project does not provide abortion and does not include abortion as a
method of family planning. Such assurance must also include, at a
minimum, representations (supported by documentary evidence where the
Secretary requests it) as to compliance with this section and each of
the requirements in Sec. Sec. 59.14 through 59.16. A project supported
under this subpart must comply with such requirements at all times
during the project period.'' The Department believes this change
addresses the confusion raised by the commenter concerning how the
definition of grantee applies in Sec. 59.13.
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\92\ As discussed above, the Department believes the concern
raised by the commenter does not require a change to the definitions
of ``grantee'' and ``project'' in Sec. 59.2, since they are clear,
and not the subject of the commenter's concern.
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The Department disagrees with commenters who contend the proposed
rule at Sec. 59.13 gives improper or unprecedented regulatory
authority to the Department beyond the concern addressed above. Title X
authorizes the Secretary to promulgate regulations governing grants and
contracts issued in the program. 42 U.S.C. 300a-4. Thus, the Department
is authorized, and in many cases required to, apply requirements both
to primary grantees and to subrecipients of Title X funds. This
includes the requirements set forth in section 1008.
[[Page 7758]]
The Department disagrees with commenters who assert that the
regulations do not articulate how compliance should be demonstrated
under Sec. 59.13, and what documentary evidence would be necessary to
provide this assurance. The plain text in proposed Sec. 59.13 would
require that the grantee provide representations of compliance with the
section and each of the requirements in Sec. Sec. 59.14 through 59.16,
and be prepared to support the representations with documentary
evidence of compliance if requested by the Department. Proposed Sec.
59.17(b) similarly requires the establishment and documentation of
certain protocols, plans and training related to knowledge of and
compliance with certain State or local notification or reporting
requirements. The grantee would provide a representation or assurance
that it has adopted the required protocols and conducted/provided the
required training. The types of documentary evidence that might be
required could include (1) copies of the protocols or plans that have
been adopted and implemented; (2) copies of the training materials; (3)
training session sign in sheets; and (4) notations in patients' records
as to reporting, notification, or in the case of minors, screening for
abuse or victimization. To the extent that additional documentation is
required by the Secretary at a later date, future guidance will be
communicated to grantees.\93\
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\93\ Grantees are already required to affirm that neither they
nor any of their subrecipients provide abortion as a method of
family planning. At the present time, the Department contemplates a
narrow compliance requirement where the grantee assures the
Department of compliance and provides adequate representations to
bolster that assurance, such as those discussed above.
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I. Requirements and Limitations With Respect to Post-Conception
Activities (42 CFR 59.14)
Summary of changes: The proposed rule would add Sec. 59.14, which
would provide guidance to grantees regarding the requirements and
limitations of the Title X program with respect to the post-conception
activities of projects and clinics. Sections 59.5(a)(5) and 59.16(a)
contain related provisions. Because many comments on these related
sections overlap, some comments (and responses) in this section are
also applicable to those sections as well.
Comments concerning the prohibition on providing or performing
abortion as a method of family planning are addressed above in the
discussion of the definition of ``family planning'' in Sec. 59.2 and
in the discussion of the prohibition on providing, promoting, referring
for, or supporting abortion as a method of family planning in Sec.
59.5(a)(5).
Comments concerning the rescission of the requirement in the 2000
regulations to provide abortion counseling, information, and referrals,
and concerning nondirective pregnancy options counseling under this
rule, are addressed above in the discussion of Sec. 59.5(a).
Comments concerning the prohibition on referral for abortion as a
method of family planning, on the promotion, or support of abortion as
a method of family planning, and on taking affirmative action to assist
a patient to secure an abortion, are considered here, and relate to
Sec. 59.14 as well as parts of Sec. Sec. 59.5(a)(5) and 59.16(a).
The Department finalizes the language at Sec. 59.14 with changes
in response to public comments, as discussed below.
1. Prohibition on Referral for, and Encouragement, Promotion, Advocacy,
Support, and Assistance of, Abortion as a Method of Family Planning (42
CFR 59.14(a), Inclusive of Pertinent Portions of Sec. Sec. 59.5(a)(5),
and 59.16(a))
Summary of changes: The first sentence of proposed Sec. 59.14(a)
would provide that ``[a] Title X project may not perform, promote,
refer for, or support abortion as a method of family planning, nor take
any other affirmative action to assist a patient to secure such an
abortion.'' This sentence remains unchanged in the final rule. The
remaining language in Sec. 59.14(a) would permit doctors to provide a
list of licensed, qualified, comprehensive primary health care
providers (some of which may also provide abortion services) and
guidance on circumstances when the list could be provided. The
Department now finalizes language in the first sentence without change.
In response to comments, the Department has updated the remaining
language of Sec. 59.14(a), regarding the list of comprehensive health
service providers and has updated the examples listed at the end of
Sec. 59.14. Further discussion of these changes regarding the list is
included in the subsection below, entitled ``Information About Prenatal
Care, Use of Permitted Information To Refer For Abortion, and Examples
(42 CFR 59.14(b), (c), and (e)).'' A further discussion of this
prohibition is also included in the discussion of Sec. 59.16, which
contains a related provision.
Comments: Many commenters strongly support the proposed language to
prohibit Title X projects from referring for abortion as a method of
family planning and from promoting, supporting, encouraging, advocating
for, or assisting abortion as a method of family planning. They contend
these prohibitions are consistent with Congressional intent for Title
X, including in section 1008 of the PHS Act. Some commenters note that,
in Rust, 500 U.S. at 17892, the Supreme Court upheld a prohibition on
abortion referrals in the 1988 regulations as being both
constitutionally valid and a permissible implementation of the
statutory restrictions on the program. Another commenter states that
the government is permitted to direct how Title X funds are spent,
consistent with the Title X statute, and that this sustains the
prohibition on referrals. The commenter contends the proposed rule
would ensure not only that program funds are not used to directly
provide abortions, but also that program funds do not support loopholes
by which some providers abuse the system to refer for abortion as a
method of family planning. Another commenter supports the proposed rule
because it will be consistent with a number of State laws that prohibit
Title X providers from referring for abortions.
Other commenters oppose the prohibition on abortion referrals. A
significant number of commenters call the prohibition a gag rule,
arguing it restricts providers from speaking freely with their patients
about every health concern they may have. They state that this
prohibition violates ethical standards and undermines the patient-
provider relationship, noting that a health care provider should not
fail to provide certain services, namely those associated with
abortion, because of private religious beliefs. Some commenters also
contend the proposed changes disregard the consciences of providers who
support ensuring patient access to information related to abortion and
abortion-related services, including providing abortion referrals. And
some commenters state that the abortion referral prohibitions in the
proposed rule regulate activities outside the Title X program and are,
therefore, illegal.
A commenter supporting the proposed rule disputes the
characterization of the prohibition on abortion referrals and promotion
as a gag rule. The commenter contends the language merely implements
what the law already requires and does not prevent physicians or APPs
from providing nondirective counseling as long as it is done in a
manner consistent with the Title X statute. In addition, the commenter
notes that abortion referral prohibitions do not prevent a doctor from
making medical determinations on behalf of a patient that require
services
[[Page 7759]]
outside of the scope of the Title X program.
Response: Having examined its past rules governing the Title X
program, the public comments on this issue, and the Department's
interpretations of section 1008's prohibition on funding Title X
programs ``where abortion is a method of family planning,'' the
Department concludes that the requirement in the 2000 regulations for
abortion referral is inconsistent with the Department's current
interpretation of section 1008.\94\ The language of Section 1008 goes
beyond merely prohibiting the funding of abortion (which is addressed
in the Title X appropriation provision), or of projects that perform
abortion. The Title X statute prohibits spending Title X funds on
programs where abortion is treated as a method of family planning. This
prohibition impacts Title X projects in a variety of ways. If a Title X
project refers for, encourages, promotes, advocates, supports, or
assists with, abortion as a method of family planning, it is a program
``where abortion is a method of family planning'' and the Title X
statute prohibits Title X funding for that project. For this reason,
the Department agrees with commenters who support the language
prohibiting such activities in the proposed rule as legally permissible
and appropriate.
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\94\ As discussed supra at I(A)(2)(c) Nondirective Pregnancy
Counseling Permitted, Not Required and elsewhere in this preamble,
such a requirement also raises issues under the Church, Coats-Snowe,
and Weldon Amendments.
---------------------------------------------------------------------------
The Supreme Court has already recognized the reasonableness of this
interpretation. In Rust, the Supreme Court upheld the provisions in the
1988 regulations that a Title X project may not ``provide counseling
concerning the use of abortion as a method of family planning or
provide referral for abortion as a method of family planning,''
provisions implementing that prohibition, and provisions stating a
Title X project may not ``encourage, promote, or advocate abortion as a
method of family planning'' or ``assist women to obtain abortions.''
See 53 FR 2923-2924; Rust, 500 U.S. at 179-80. The Supreme Court held
that ``[t]he broad language of Title X plainly allows the Secretary's
construction of the statute'' to prohibit abortion referral,
counseling, and advocacy, and the Secretary ``amply justified his
changed interpretation.'' Rust, 500 U.S. at 184-87. The Court further
concluded ``[t]here is no question but that the statutory prohibition
contained in Sec. 1008 is constitutional,'' because Congress ``may
`make a value judgment favoring childbirth over abortion, and . . .
implement that judgment by the allocation of public funds.' '' Id. at
192 (internal citations omitted; ellipses in original). The court
explained that the challenged provisions of the 1988 regulations were
also consistent with the First Amendment:
The challenged regulations implement the statutory prohibition
by prohibiting counseling, referral, and the provision of
information regarding abortion as a method of family planning. They
are designed to ensure that the limits of the federal program are
observed. The Title X program is designed not for prenatal care, but
to encourage family planning. A doctor who wished to offer prenatal
care to a project patient who became pregnant could properly be
prohibited from doing so because such service is outside the scope
of the federally funded program. The regulations prohibiting
abortion counseling and referral are of the same ilk. . . . This is
not a case of the Government `suppressing a dangerous idea,' but of
a prohibition on a project grantee or its employees from engaging in
activities outside of the project's scope.
Id. at 193-94.
The Department disagrees with the view of some commenters that the
prohibitions on referral for, encouragement of, promotion of, advocacy
for, support of, or assistance with, abortion as a method of family
planning regulate non-Title X activities. The Department intends these
prohibitions to apply only to the Title X project. The Supreme Court,
in Rust rejected a First Amendment claim in which the challengers
contended that similar regulations apply outside the Title X project,
stating that ``[t]he Secretary's regulations do not force the Title X
grantee to give up abortion-related speech; they merely require that
the grantee keep such activities separate and distinct from Title X
activities. . . . The regulations govern the scope of the Title X
project's activities, and leave the grantee unfettered in its other
activities.'' Rust, 500 U.S. at 196. Furthermore, the Court stated that
an entity that receives Title X funds ``can continue to perform
abortions, provide abortion-related services, and engage in abortion
advocacy; it simply is required to conduct those activities through
programs that are separate and independent from the project that
receives Title X funds.'' Id.
The Department also disagrees with commenters who contend that
prohibiting referring for, promoting, supporting, encouraging,
advocating for, or taking any other affirmative action to assist a
patient to secure, abortion as a method of family planning in Title X
projects violates the Church Amendment rights of Title X projects or
their employees. Although paragraph (c)(1) of the Church Amendments
protects personnel on the basis that they ``performed or assisted in
the performance of a lawful . . . abortion,'' \95\ those are not
inconsistent with the clear statutory prohibition that funds may not be
provided to Title X projects where abortion is a method of family
planning. Projects can comply with this prohibition on the use of Title
X funds without discriminating against personnel in a way that violates
the Church Amendments.
---------------------------------------------------------------------------
\95\ 42 U.S.C. 300a-7.
---------------------------------------------------------------------------
The Department, thus, finalizes the first sentence of Sec.
59.14(a).
2. Information About Prenatal Care, Use of Permitted Information To
Refer for Abortion, and Examples (42 CFR 59.14(b)(1), (c), and (e))
Summary of changes: The proposed rule would provide in Sec.
59.14(b) that, once a Title X client is diagnosed as pregnant, she must
be referred for appropriate prenatal and/or social services. The
proposed rule also would have required that the project provide any
information necessary to protect her health and the health of the
unborn child until the referral appointment is kept, including referral
for emergency medical services when appropriate. In Sec. 59.14(c), the
proposed rule would have acknowledged the duty of a physician to
promote patient safety in allowing a doctor to provide a list, if
asked, of licensed, qualified, comprehensive health service providers,
some of which may provide abortion in addition to comprehensive
prenatal care. In paragraph (e), the Department would set out several
examples to illustrate the application of the requirements of
paragraphs (a) through (d).
The Department finalizes Sec. 59.14(b)(1) with changes, including
to permit the provision of a single list of licensed, qualified,
comprehensive primary health care providers (including providers of
prenatal care) to pregnant clients. In addition, the final rule
requires referral for prenatal care since such care is medically
necessary to maintain or improve the health of both the mother and the
unborn baby. The Department simplifies and clarifies the description of
pregnancy health information in this final rule to read ``[i]nformation
about maintaining the health of the mother and unborn child during
pregnancy.''
The Department also finalizes provisions addressing the permissive
nature of nondirective pregnancy counseling and the provision of
information about pregnancy health.
[[Page 7760]]
The Department is simplifying this language and separating the
requirements into enumerated subparagraphs of paragraph (b)(1) for
clarity. The final rule, thus, specifies that referrals for prenatal
care are required, because of its medical necessity due to pregnancy.
Further, the Title X provider may also choose, but is not required to,
provide nondirective pregnancy counseling, referrals to social services
or adoption agencies, and information consistent with Section 1008 and
appropriate post-conception activities under Title X regulation.
As discussed below, the Department also finalizes, as proposed, the
final sentence in proposed paragraph (b) concerning cases that require
emergency care as paragraph (b)(2).
The Department finalizes Sec. 59.14(c) with changes in response to
comments, including the consolidation of the two lists of comprehensive
health care providers (from paragraphs (a) and (c) of the proposed
rule) into one list and the addition of the requirement that the list
and project staff not identify which providers on the list, if any,
perform abortion.
The Department finalizes Sec. 59.14(e), which sets forth examples
illustrating the rules described in paragraphs (a) through (d), with
changes consistent with the changes to those subsections.
Comments: Many commenters oppose the list of providers that may be
shared with pregnant patients who request abortion. Commenters believe
the list lacks necessary detail, may be difficult to understand for
some patients, and difficult to implement for some providers because of
the lack of comprehensive service providers who also provide abortion
in their community.
Other commenters oppose the fact that the list may include some
health providers that perform abortions, contending that Title X
projects should not provide women seeking abortion with any list of
providers that perform abortion. They contend providing such a list, or
any information a woman may use to obtain an abortion, would violate
section 1008 as it would make the project one ``where abortion is a
method of family planning.'' Such commenters also contend providing
such a list would constitute a referral for abortion. They point to the
proposed rule, published by the HHS Office for Civil Rights in January
2018 to implement conscience laws such as the Weldon Amendment,
defining referral as providing information that could provide
assistance in obtaining a particular health care service. See 83 FR
3880, 3924 (Jan. 26, 2018).\96\
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\96\ That proposed rule has not yet been finalized.
---------------------------------------------------------------------------
Several commenters contend that rule's description of two lists--
one that may include abortion providers to be given to pregnant
patients who want an abortion (described in Sec. 59.14(a) and (c)),
and another (described at the end of Sec. 59.14(a)) that does not
include abortion providers and that would be given to all other
pregnant patients--is confusing and cumbersome for both the patient and
the provider.
Other commenters object to the requirement that only doctors are
permitted to give the list of providers to a woman seeking abortion
described in Sec. 59.14(a) and (c).
Some commenters assert that requiring referrals for pregnant
patients to obtain prenatal and/or social services, regardless of the
patient's wishes, violates the Congressional requirement that all Title
X counseling be nondirective.
Many commenters present objections to the examples set forth in
subsection (e) consistent with their objections to the requirements of
subsection (a) that those examples illustrate.
Response: The Department agrees that it is appropriate to implement
section 1008 to prohibit referrals for, and encouragement, promotion,
advocacy, support, and assistance of abortion. The Department also
agrees that, while nondirective pregnancy counseling is permissible in
Title X projects by physicians or APPs, even if nondirective abortion
counseling is provided among other options (so long as the counseling
falls within parameters of the Title X statute and this regulation),
abortion referral is inconsistent with the prohibition against funding
Title X projects where abortion is a method of family planning.
The Department's approach to counseling is somewhat different than
in the 1988 regulations, which, in addition to prohibiting abortion
referrals, also prohibited ``counseling concerning the use of abortion
as a method of family planning.'' In subsequent years, Congress has
indicated that nondirective postconception counseling would be
permissible, without requiring that any such counseling occur. It has
done so through appropriations law provisions requiring that any
pregnancy counseling offered in Title X projects be nondirective.\97\
The Department believes these enactments make it appropriate for the
Department to allow nondirective pregnancy counseling in Title X
projects by physicians or APPs, even if the counseling includes
nondirective counseling on abortion. Although Congress did not require
projects to offer pregnancy counseling, a permissible interpretation of
the statutory provision requiring that any such counseling be
nondirective is that abortion may be discussed in a nondirective way.
The Department believes that it would also be a permissible
interpretation to conclude that, even without discussion of abortion,
other nondirective counseling should be presented to the pregnant
woman. In the absence of more specific direction from Congress in the
nondirective counseling provision, the Department concludes that it is
permissible to interpret the various statutory requirements for Title X
so as to permit projects to provide nondirective pregnancy counseling,
even if it involves counseling on abortion, as long as that counseling
is truly nondirective.
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\97\ See Omnibus Consolidated Rescissions and Appropriations Act
of 1996, Public Law 104-134, sec. 104, 110 Stat. 1321; HHS
Appropriations Act 2019, Public Law 115-245, Div. B, 132 Stat. 3070.
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As clarified by the direction given by Congress, nondirective
counseling is consistent with the provision as analyzed in Rust. The
1988 regulations upheld in Rust stated a Title X project may not, among
other things, ``provide counseling concerning the use of abortion as a
method of family planning,'' ``provide referral for abortion as a
method of family planning,'' ``encourage, promote or advocate abortion
as a method of family planning,'' or ``use prenatal, social service or
emergency medical or other referrals as an indirect means of
encouraging or promoting abortion as a method of family planning, such
as by weighing the list of referrals in favor of health care providers
which perform abortions, by including on the list of referral providers
health care providers whose principal business is the provision of
abortions, by excluding available providers who do not provide
abortions, or by `steering' clients to providers who offer abortion as
a method of family planning.'' Rust, 500 U.S. at 179-80 (citing 42 CFR
59.8(a)(1)-(3) (ed. 1988)). In upholding those provisions, the Supreme
Court added that the Department may also prohibit ``abortion-related
speech'' and ``abortion advocacy'' in a Title X project. Rust, 500 U.S.
at 175. The language of this final rule, which at Sec. Sec. 59.14(a)
and 59.16(a) similarly prohibits a Title X project from referring for,
promoting, supporting, encouraging, advocating for, or taking any other
affirmative action to assist a patient to secure, abortion as a method
[[Page 7761]]
of family planning, is consistent with the provisions of the 1988
regulations that the Supreme Court upheld in Rust. Thus, the Supreme
Court's conclusions upholding these provisions of the 1988 regulations
would be equally applicable to this final rule and the permissions
surrounding nondirective pregnancy counseling.
The Department has seriously considered the many comments offered
regarding the two lists referenced in proposed Sec. 59.14(a) and (c):
One list required for pregnant clients generally, and another list
permitted in the more specific circumstance where pregnant clients have
decided to seek an abortion and request an abortion referral. The
Department agrees that the proposal for two lists to be provided in two
different and specific circumstances was potentially confusing and/or
burdensome for projects which might be confused or unclear about how to
develop and implement the lists. The proposed rule's duplicative
description (in both paragraphs (a) and (c)) of the more specific list
allowed when a client requests abortion may also have been confusing.
And although the proposed rule attempted to describe, in more detail,
how a project would respond to requests for abortion or abortion
referrals, the Department concludes that description was also
potentially confusing and is unnecessary in the final rule.
The Department is finalizing Sec. 59.14(b)(1)(ii) to allow Title X
providers to give a single list of providers to any pregnant woman.
This list will contain licensed, qualified, comprehensive primary
health care providers (including providers of prenatal care). At Sec.
59.14(c), the Department consolidates and finalizes the description and
requirements applicable to such list. The Department permits, but does
not require, some providers on the list of comprehensive primary health
care providers (including providers of prenatal care) to be providers
that also provide abortion. The Department believes this will enable
some projects to create a single list of comprehensive primary health
care providers (including providers of prenatal care). For example,
some service sites might find that the main provider of comprehensive
primary or prenatal health care services is a hospital that also
performs some abortions. At the same time, projects cannot create or
distribute a list in which every provider (or a majority) on the list
provides abortion. Projects, however, may compile their list so that no
providers of abortion are on the list.
Because referrals for abortion as a method of family planning are
prohibited, the list of comprehensive primary health care providers
(including providers of prenatal care) that Title X projects and
providers may provide to pregnant clients (and which may include
abortion providers) cannot be used to indirectly refer for abortion or
to identify abortion providers to a client. Thus, in the circumstance
where a pregnant woman asks for an abortion or an abortion referral for
family planning purposes, the project's response would be to say it
does not refer for abortions, and then to offer her, if she desires, a
list of comprehensive primary health care providers (including
providers of prenatal care); that list could include (but not identify)
such providers that also perform abortions.
The Department believes these limitations on the list of
comprehensive primary health care providers (including providers of
prenatal care), as well as the context in which the list would be
provided, prevents distribution of that list from violating section
1008, even if some providers on the list also provide abortions. There
are many potential reasons or purposes for a Title X provider to
provide the list to a pregnant patient. If provision of the list is for
a referral purpose, it must be for a permissible purpose, such as to
refer the patient for prenatal care or for care of pre-existing
maternal health conditions, not for the purpose of referring for
abortion as a method of family planning. The final rule prohibits the
list and project staff from identifying which, if any, providers on the
list provide abortions. The Department, therefore, disagrees with some
commenters who contend that including any abortion providers on a list
of comprehensive primary and/or prenatal health care providers would
render the project one ``where abortion is a method of family
planning.''
In response to comments, the Department has decided to eliminate
the requirement that a list provided specifically to women seeking
abortion referrals be provided only by a doctor. Some commenters object
to this requirement and note that the proposed rule did not require the
list of prenatal care referrals, which was to be provided to all
pregnant women, to be provided only by a doctor. Upon consideration of
these comments, the Department has decided not to finalize any
restriction on which personnel may provide the list to a pregnant
patient. Any member of the Title X staff may provide the list, but only
physicians and APPs may provide any nondirective pregnancy counseling.
In light of section 1008 and federal conscience laws, the
Department has concluded it will not require Title X projects to offer
nondirective counseling or information about abortion. The Department
similarly will not require projects to offer nondirective pregnancy
counseling on other subjects if they choose not to do so. Congress did
not require that projects offer pregnancy counseling, but only that
such counseling be nondirective, when/if offered. The Department
concludes that the final rule should take a similar approach.
Accordingly, this rule does not require a Title X project to offer
abortion-related pregnancy counseling (or pregnancy counseling at all).
When a project chooses to offer such pregnancy counseling, it must be
nondirective. The clinic may offer referral services except that, given
the statutory parameters set forth in Section 1008, a project is not
permitted to provide referrals for abortion as a method of family
planning.\98\ As noted above, with respect to Sec. 59.5(a)(5), this
final rule rescinds the requirement of pregnancy options counseling
from the 2000 regulations. This final rule neither requires nor
prohibits pregnancy counseling (although pursuant to Congressional
mandate, if such counseling occurs, it must be nondirective).
Consistent with federal law (including the requirements of this final
rule), Title X projects and providers must comply with all applicable
laws concerning the practice of medicine and the offering of medical
advice, as they may apply to the Title X project or provider that
provides pregnant clients with nondirective pregnancy counseling, a
list of comprehensive primary and prenatal health care providers,
prenatal care referrals, assistance with setting up referral
appointments, or information about pregnancy health.
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\98\ Projects may permit each Title X clinic to make the
decision whether it will provide each aspect of permissible
counseling. The Department notes, however, that clinics, providers,
and staff cannot be required to counsel on abortion if, for example,
such activity would be contrary to their religious beliefs or moral
convictions.
---------------------------------------------------------------------------
Some commenters contend that providing prenatal care referrals
violates Congress's requirement that pregnancy counseling be
nondirective. The Department responds to this comment above in its
discussion of referrals for prenatal care and adoption in Sec. 59.2.
Prenatal care is medically necessary for any patient who is pregnant,
so referrals for such care do not render counseling directive.
Moreover, the Department notes that low income women are more likely to
deliver low birthweight babies
[[Page 7762]]
and to deliver before term, and less likely to access adequate prenatal
care services. Yet prenatal care is one of 14 mandatory categories of
Medicaid services and is deemed medically necessary for pregnant women.
Because prenatal care is essential in order to optimize the health of
the mother and unborn child, and to help ameliorate the current health
inequality as it relates to low income women,\99\ referring low income
pregnant women for prenatal care is of increased importance.\100\
Therefore, the Department adds additional clarity regarding referrals
for prenatal care in an example in Sec. 59.15(e)(1). The Department
continues to believe that Title X projects are well situated to provide
such referrals.
---------------------------------------------------------------------------
\99\ Tanya Nagahawatte and Robert L. Goldenberg, Poverty,
Maternal Health, and Adverse Pregnancy Outcomes, 1136 Ann. N.Y.
Acad. Sci. 80, 81 (2008), https://www.ncbi.nlm.nih.gov/pubmed/17954684.
\100\ Rita Hamad and David H. Rehkopf, Poverty, Pregnancy, and
Birth Outcomes: Earned Income Tax Credit, 29(5) Paediatr Perinat
Epidemiol 444-452, Jul. 24, 2015. PMCID: PMC4536129.
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The Department does not, however, agree with the commenter who
proposes that Title X providers are responsible for prenatal care.
While the Department agrees that prenatal care is important to maternal
and infant outcomes, and encourages Title X providers to provide
comprehensive health care services onsite or through robust referral
networks, the provision of postconception and pregnancy services (as
distinct from information and referrals for them) are outside the scope
of Title X.
Accordingly, the Department is finalizing this section as discussed
to simplify and clarify the approach set forth in the proposed rule.
Consequently, Sec. 59.14(a) is finalized to prohibit Title X projects
from referring for abortion, which includes ``any affirmative action to
assist a patient to secure such an abortion.'' Section 59.14(b)(1) is
also finalized to only require Title X projects to refer pregnant
clients to a ``health care provider for medically necessary prenatal
health care.'' Subsection (b)(1) also establishes that the Title X
provider may also provide certain specified counseling and/or
information to the pregnant woman. Finally, subsection (b)(2)
establishes that, in cases requiring emergency care, referral is
required ``to an appropriate provider of medical services needed to
address the emergency.'' \101\ Section 59.14(c) is finalized to
establish that a Title X project may not use lists, referrals, or
counseling ``as an indirect means of encouraging or promoting abortion
as a method of family planning.'' Subsection (c) further establishes
that while the list may include some providers who provide abortion
services, ``[n]either the list nor project staff may identify which
providers on the list perform abortion.''
---------------------------------------------------------------------------
\101\ This sentence in Sec. 59.14(b) is addressed in the
immediately below section.
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The Department is finalizing the changes described above to reduce
confusion, facilitate implementation of the rule, provide pregnant
clients with counseling and information for prenatal care and
information to promote the health of the mother and unborn child, and
implement section 1008 to ensure Title X does not fund projects where
abortion is a method of family planning. The Department also finalizes
the examples in paragraph (e), with changes corresponding to the
changes made in paragraphs (a) through (d).
3. Emergency Care and Medically Necessary Information (42 CFR
59.14(b)(2) and (d))
Summary of changes: In the last sentence of Sec. 59.14(b), the
proposed rule would require that, ``[i]n cases in which emergency care
is required, the Title X project shall only be required to refer the
client immediately to an appropriate provider of emergency medical
services.'' The Department finalizes Sec. 59.14(b)(2), in response to
comments discussed below, by replacing ``an appropriate provider of
emergency medical services'' with ``an appropriate provider of medical
services needed to address the emergency.''
At Sec. 59.14(d), the proposed rule would provide: ``Provision of
medically necessary information. Nothing in this subpart shall be
construed as prohibiting the provision of information to a project
client that is medically necessary to assess the risks and benefits of
different methods of contraception in the course of selecting a method,
provided that the provision of such information does not otherwise
promote abortion as a method of family planning.'' The Department
finalizes Sec. 59.14(d) without change.
Comments: Some commenters object that the proposed rulemaking does
not allow for medically necessary, but non-emergency, referrals for
abortion. These commenters state that when maternal and child health
outcomes will be compromised if a pregnancy is continued, or if
appropriate treatment and services are delayed, referral for abortion
is needed.
Several commenters express concern that the proposed language would
allow providers to refer patients who need emergency care only to an
emergency room, which may not be the best place for the patient. They
assert that this will increase unnecessary emergency room use.
Commenters ask the Department to clarify in the rulemaking that
providers be allowed to refer the pregnant woman to the provider that
is clinically appropriate for the patient.
Several other commenters request that the Department clarify the
language in the proposed rulemaking regarding women who experience
ectopic pregnancies and other life-threatening conditions related to
pregnancy. They contend that the exception for ``danger of death''
should be included in the discussions of the Hyde Amendment. They
contend this would assure that Title X providers have accurate
information to be compliant and consistent among federal agencies.
Response: The Department disagrees with commenters contending that
restrictions in the rule on referral and directive counseling affect
situations concerning emergency or medically necessary care. Section
1008 prohibits funding for Title X projects where abortion is a method
of family planning, and the final rule's restrictions on referral,
promotion, or encouragement of abortion are similarly limited to
abortion as a method of family planning. Referral for abortion because
of an emergency medical situation does not fall into restrictions
concerning abortion as a method of family planning. Paragraph (b)(1) of
Sec. 59.5 of the final rule makes clear that Title X grantees and
subrecipients not only may, but must, provide for ``referral to other
medical facilities when medically necessary.'' See also Sec.
59.5(b)(8).\102\
---------------------------------------------------------------------------
\102\ As noted above, Title X projects and service providers
must ensure that they do not, under the cover and pretext of
providing such abortion referral, actually refer for abortion as a
method of family planning. This is an area in which Title X projects
can expect OPA monitoring and oversight, and should maintain
appropriate records to support such referrals.
---------------------------------------------------------------------------
The Department appreciates commenters who suggest that the final
sentence in proposed Sec. 59.14(b) limits referral to emergency rooms.
The Department agrees with a commenter who stated that a hospital
emergency room may not always be the most appropriate referral location
and that the referral should be commensurate with the medical need.
Because the text of the proposed rule would require only referral to
``an appropriate provider of emergency medical services,'' the
Department finalizes this language with clarification to avoid
confusion and to emphasize, ``[i]n cases in which emergency care is
required, the Title X project shall only be required to refer the
client immediately to an appropriate provider of medical services
needed to
[[Page 7763]]
address the emergency.'' This language is intended to emphasize that it
does not require that such referral be to an emergency room.
It is also not the intent of the regulatory provisions at Sec.
59.14(b)(2) or Sec. 59.5(b)(1) to restrict the ability of health
professionals to communicate to a patient any information they discover
in the course of physical examination (or otherwise) about her medical
condition, such as an extant condition that might make her pregnancy
high risk; to communicate an assessment of the urgency of the need for
treatment; or to ensure that a patient is referred to the appropriate
specialist for treatment of the condition, consistent with the exercise
of his or her professional judgment and the parameters of the Title X
program. The restrictions in these provisions solely concern abortion
as a method of family planning. For this reason, the Department
disagrees that these provisions of the final rule will increase medical
liability, or will prohibit Title X projects from providing the factual
information necessary to assess risks of a particular family planning
or contraceptive method as set out in the patient package inserts.
As noted, at Sec. 59.14(c), the final rule will also provide that
a Title X project may not use emergency medical or other referrals as
an indirect means of encouraging or promoting abortion as a method of
family planning.
J. Maintenance of Physical and Financial Separation (42 CFR 59.15)
The proposed rule, at Sec. [thinsp]59.15, would require physical
and financial separation of a Title X project or facility from
prohibited activities (e.g., abortion as a method of family planning).
The Department finalizes this section without change. The
Department finalizes the compliance date for this section, as set forth
in Sec. 59.19, with changes in response to public comments, as
discussed below.
Comments: Many commenters express support for the proposed
financial and physical separation provisions and the Department's
efforts to enforce the restrictions. These commenters agree that the
proposed separation provisions will ensure statutory compliance with
section 1008, eliminate potential confusion, and reduce the use of
Title X funds for non-Title X services. One commenter adds that
maintaining separate funds is a common requirement for federal grants
and contracts. Another commenter states that, as upheld in Rust v.
Sullivan, the Secretary is entitled to interpret Title X to include
``separate facilities.'' Several commenters point out that the proposed
separation amendments are consistent with numerous State laws.
Many other commenters contend that the proposed financial and
physical separation requirements and reduced flexibility of funds are
illegal, not intended by Congress, burdensome, and unworkable. To
begin, commenters claim that the Department fails to adequately justify
why the change is necessary and argue that concerns about fungibility
or possible co-mingling of funds are flawed. They assert that Title X
already prohibits clinics from using federal funds to provide abortions
and requires that funds used for abortion be kept separate, and that
regular, extensive, and comprehensive audits currently are already used
to enforce the existing rule. They contend that the 2000 regulations
have successfully ensured separation compliance and that no additional
measures are needed. They also contend that improving public education
efforts so the public understands Title X funds cannot be used for
abortion, would make physical separation unnecessary. These commenters
urge the Department to withdraw the new separation requirement, or at a
minimum, to provide clearer justifications for the requirement.
Some commenters focus on the possible burden and workability of the
rule. They contend that the Department lacks evidence that the rules
are feasible, particularly because the separation requirements in the
1988 regulations, which were nearly identical to the proposed rule
here, were never fully implemented. They assert that the Department
neglected to do adequate research and analysis of how the proposed
changes would interact with various State laws, including laws that
govern medical licensure and scope of practice. Some commenters state
that a Department notice (Provision of Abortion-Related Services in
Family Planning Projects, 65 FR 41281, 41282 (July 3, 2000)) allows
Title X service sites to use common waiting rooms, staff, filing
systems, and other resources and argue that changes to this approach
would impair the family planning network by constraining certain
providers' ability to participate in the Title X program. They state,
for example, that many Title X grantees are hospitals that must be able
to perform abortions in emergency situations and would not be able to
afford separate infrastructure. Other commenters contend that the
financial separation provisions would increase the cost of medical
supplies and reduce grantees' ability to make cost-effective bulk
purchases. Some commenters contend that 60 days from the date the final
rule is published is insufficient time to accomplish the requirement of
separate electronic health records. One commenter urges the Department
to consult with a diverse group of Title X providers to calculate the
monetary and time costs to comply with the proposed changes.
Some commenters contend that the rule will harm patient care. They
state that, for women seeking both Title X services and abortion, the
rule would require two separate visits to separate facilities because
of effects of the restrictions on same-day post-abortion contraception.
They claim that the need for two separate visits would create
unnecessary costs and obstacles to care. Other commenters express
concern that the new provisions would exacerbate health inequalities in
terms of sexually transmitted diseases (STDs) among low income people
affected by the loss of Title X providers. Some commenters state that
the separation provisions undermine the objectives of integrated care
and health systems. Similarly, many commenters argue that the
requirement for separate electronic medical records (EHR) contradicts
the principles of integrated, patient-centered medical care. They
contend the financial separation requirement could lead to instances of
missing or incomplete patient data and increased costs, as the same
patient must have two separate medical records--one for Title X
services and another for abortion services.
Some commenters raise other objections. One commenter, for example,
expresses concern that the mandated physical separation would reinforce
the notion that abortion is not a normal and legal part of health care.
One commenter states that if the separation provisions force clinics
that perform abortions to close, it would impede training for residents
in obstetrics and gynecology. Another commenter expresses concern that
requiring physical separation serves to highlight locations where
abortion services are provided, which may increase the risk of those
locations being the target of violent crime or protest. Several
commenters object to the proposed signage requirements. Many other
commenters object to the rule because, in their view, it gives the
Department unrestricted authority to determine how to apply the
separation requirements, while leaving Title X programs with
insufficient guidance.
Finally, some commenters argue that mere physical and financial
separation is not enough to ensure program integrity. They recommend
Title X
[[Page 7764]]
clinics have distinctive names from clinics that offer abortions,
distinct organizational entities, organizational headquarters, or
unique signage and labeling on all Title X materials and service sites.
Response: The Department agrees with the commenters who support the
rule and the Department's legal authority to require physical and
financial separation. The rule is nearly identical to the policy set
forth in the 1988 regulations, which was upheld by the Supreme Court in
Rust v. Sullivan. 500 U.S. 173. After having reconsidered this issue,
the Department's interpretation of section 1008 in the 1988 and 2000
regulations, and the public comments, the Department reaffirms its
conclusions and its approach in the 1988 regulations with respect to
physical and financial separation, as set forth in the proposed rule.
The Department finds that the approach outlined in the proposed rule is
in line with the Congressional mandate to separate Title X funds from
those where abortion is a method of family planning. The Department
finalizes that provision, with some changes discussed below.
In the 1988 regulations, the Department noted that it was requiring
physical and financial separation because it found the regulations
inadequate without that requirement, stating that the Department found,
``as a matter of experience with Title X, its responsibility to
administer the program as provided by Congress, and its general
administrative discretion, that the provisions of the current
guidelines do not faithfully or effectively maintain the prohibition
contained in section 1008.'' 53 FR at 2923. The 1988 regulations had
several key features to address this deficiency and required compliance
with the statutory prohibition. Among those, the regulations required
grantees to separate their Title X project--physically and
financially--from any abortion activities.
Those regulations were upheld on both statutory and constitutional
grounds in Rust. 500 U.S. 173. The Supreme Court first rejected the
claim that the regulations violated the Administrative Procedure Act.
The Court concluded that--although the language of section 1008 did not
directly prescribe physical and financial separation--the ``broad
language of Title X plainly allows the Secretary's construction of the
statute.'' Id. at 184. The Court declined to view the regulations
skeptically merely because the agency had changed its view and
reaffirmed the legal principle that ``[a]n agency is not required to
`establish rules of conduct to last forever,' but rather `must be given
ample latitude to `adapt [its] rules and policies to the demands of
changing circumstances.' '' Id. at 186-87 (internal citations omitted).
The Court held the portions of the regulations mandating separate
facilities, personnel, and records were ``based on a permissible
construction of the statute and are not inconsistent with congressional
intent.'' Id. at 188. On the contrary, the Court noted, ``if one thing
is clear from the legislative history, it is that Congress intended
that Title X funds be kept separate and distinct from abortion-related
activities. . . Certainly, the Secretary's interpretation of the
statute that separate facilities are necessary, especially in light of
the express prohibition of [section] 1008, cannot be judged
unreasonable.'' Id. at 190. Accordingly, the Court ``defer[red] to the
Secretary's reasoned determination that the program integrity
requirements are necessary to implement the prohibition.'' Id.
The Court similarly rejected constitutional challenges to the
regulations. As an initial matter, it upheld the statutory limitation
of Title X funds to programs where abortion is not a method of family
planning, concluding that ``[t]here is no question but that the
statutory prohibition contained in [section] 1008 is constitutional''
because Congress ``may `make a value judgment favoring childbirth over
abortion and . . . implement that judgment by the allocation of public
funds.' '' 500 U.S. at 192-93 (internal citations omitted; ellipsis in
original). The Court explained that the requirement of physical and
financial separation was also consistent with the First Amendment:
By requiring that the Title X grantee engage in abortion-related
activity separately from activity receiving federal funding,
Congress has, consistent with our teachings . . . not denied it the
right to engage in abortion related activities. Congress has merely
refused to fund such activities out of public fisc, and the
Secretary is simply requiring a certain degree of separation from
the Title X project to ensure the integrity of the federally funded
program.
Id. at 198. The Court held that the regulations did not violate any
Fifth Amendment rights because the ``Government has no constitutional
duty to subsidize an activity merely because the activity is
constitutionally protected and [Congress] may validly choose to fund
childbirth over abortion and `implement that judgment by the allocation
of public funds' for medical services relating to childbirth but not to
those relating to abortion.'' Id. at 201 (internal quotations omitted).
The Court, thus, held that the regulations ``are a permissible
construction of Title X and do not violate either the First or Fifth
Amendments to the Constitution.'' Id. at 203.
The Department carefully considered the issue of physical and
financial separation in light of the statutory guidance of section 1008
and notes that it is similar to the 1988 regulations, which were upheld
by the Supreme Court. The Department has reconsidered the 2000
regulations, which allowed the sharing of physical space so long as
certain financial separation was maintained. The Department continues
to hold with the 2000 regulations, to the degree it requires financial
separation, that financial separation is a necessary condition to
implementing section 1008, but it no longer believes financial
separation is sufficient without physical separation. For the reasons
discussed below, financial separation without physical separation does
not sufficiently address the Congressional mandate that Title X funds
be separate and distinct from abortion-related services.
The Department disagrees with commenters who contend it has not
provided sufficient reasons or evidence to justify the physical and
financial separation requirements. In Rust, the Supreme Court upheld
imposing those requirements as a legitimate interpretation of the
Congressional mandate in section 1008, and the Department continues to
believe that the physical and financial separation requirements are in
line with that mandate. 500 U.S. at 203. But the Department also
believes that such separation would appropriately address certain
concerns it has with the current arrangements in which physical
separation is not required. First, under the current arrangement, it is
often difficult for patients, or the public, to know when or where
Title X services end and non-Title X services involving abortion begin.
As the Department explained in the proposed rule, shared facilities
create a risk of the intentional or unintentional use of Title X funds
for impermissible purposes, the co-mingling of Title X funds, the
appearance and perception that Title X funds being used in a given
program may also be supporting that program's abortion activities, and
the use of Title X funds to develop infrastructure that is used for the
abortion activities of Title X clinics. Even with the strictest
accounting and charging of expenses, a shared facility greatly
increases the risk of confusion and the likelihood that a violation of
the Title X prohibition will occur.
[[Page 7765]]
This concern is particularly acute in light of more recent evidence
that abortions are increasingly performed at sites that focus primarily
on contraceptive and family planning services--sites that could be
recipients of Title X funds. A 2014 report from the Guttmacher
Institute provides detail about the various types of facilities at
which abortions are performed.\103\ It notes that ``nonspecialized
clinics''--i.e., ``nonhospital sites in which fewer than half of
patient visits are for abortion services,'' including physicians'
offices--may provide 400 or more abortions per site per year.\104\ The
report notes that, ``[w]hile many of these [nonspecialized] clinics
primarily serve contraceptive and family planning clients, about half
provided 400 or more abortions per year.'' \105\ It defines ``abortion
clinics'' as ``nonhospital facilities in which half or more of patient
visits are for abortion services, regardless of annual abortion
caseload.'' \106\ According to the Guttmacher Institute, nonspecialized
clinics accounted for 24% of all abortions in 2008; \107\ 31% in 2011;
\108\ and 36% in 2014.\109\ In addition, nonspecialized clinics
represented 26% of abortion providers in 2008; \110\ 30% in 2011; \111\
and 31% in 2014.\112\ Further, despite a 3% drop in the total number of
abortion facilities between 2011 and 2014, the number of abortion
clinics dropped by 17%, while the number of nonspecialized clinics
performing abortions remained stable.\113\ The performance of abortions
at nonspecialized clinics that also may provide Title X services
increases the risk and potential both for confusion and for the co-
mingling or misuse of Title X funds.
---------------------------------------------------------------------------
\103\ Rachel K. Jones and Jenna Jerman, Abortion incidence and
service availability in the United States, 2014, 49 Guttmacher
Institute Perspectives on Sexual and Reproductive Health 17, 19
(2017), https://www.guttmacher.org/journals/psrh/2017/01/abortion-incidence-and-service-availability-united-states-2014.
\104\ Id. at 19.
\105\ Id. at 20.
\106\ Id. at 19.
\107\ Rachel K. Jones and Kathryn Kooistra, Abortion incidence
and access to services in the United States, 2008, 43 Guttmacher
Institute Perspectives on Sexual and Reproductive Health 41, 46
(2011), https://www.guttmacher.org/sites/default/files/pdfs/pubs/psrh/full/4304111.pdf.
\108\ Rachel K. Jones and Jenna Jerman, Abortion incidence and
service availability in the United States, 2011, 46 Guttmacher
Institute Perspectives on Sexual and Reproductive Health 3, 6
(2014), https://www.guttmacher.org/sites/default/files/article_files/abortion_incidence_in_the_united_states_2011.pdf.
\109\ See Jones 2017, supra at 20.
\110\ See Jones 2011, supra at 46.
\111\ See Jones 2014, supra at 6.
\112\ See Jones 2017, supra at 20.
\113\ See Jones 2017, supra at 20.
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Together, these circumstances create a risk of intentional or
unintentional misuse of Title X funds and have created public confusion
over the scope of Title X services, about whether Title X projects
provide abortion services, and about whether federal taxpayers fund
abortion services provided by organizations that are grantees (or
subrecipients) of Title X grants/funds. The Department believes that
such potential co-mingling and confusion provides sufficient supporting
evidence, in addition to the Department's rationale for physical and
financial separation upheld in Rust (which the Department also adopts
now), that the 2000 Regulations neither adequately reflect nor ensure
compliance with the text and purpose of section 1008. It is generally
the Department's view that, if it is difficult to distinguish Title X
activities from non-Title X activities, then adequate physical
separation has not been achieved.
As discussed above, the Department interprets section 1008 to
require Title X project activities to be separate and distinct from
prohibited activities (e.g., abortion as a method of family planning).
Thus, the Department finalizes the proposed text of Sec. 59.15 so
that, when a grantee or subrecipient conducts abortion activities that
are not part of the Title X project, and would not be permissible if
they were, the grantee must ensure that the Title X-supported project
is separate and distinguishable from those other activities.
The Department disagrees with comments opposing the requirement of
physical separation on the basis that other means exist to achieve same
goals of the proposed rule while still allowing the Title X project and
a program engaged in prohibited activities to occupy the same physical
space. The Department considered other alternatives to physical
separation. For example, it considered whether signs or brochures could
be posted to indicate distinctions between the Title X project and
Title X prohibited activities, or whether separate staff and
examinations rooms within the same area in the facility could
sufficiently delineate a separation between the Title X project and
abortion-related services. The Department has determined, however, that
a shared reception area with materials available on both Title X family
planning services and abortion-related services would not resolve the
confusion, but could allow it to continue. Signage is often not read,
and the segregation of staff or staff responsibilities would not, in
the Department's view, provide sufficient distinction to end confusion.
Single facilities often have staff fulfilling distinct roles without
making the program itself separate. Patients might not be aware of the
distinction made between different examination rooms if the entrance
and reception area is shared in common, especially in a smaller
facility. The optics and practical operation of two distinct services
within a single collocated space do not sufficiently create the
separation Congress intended when it said Title X funds cannot be spent
``where'' abortion is a method of family planning. As in its 1988
regulations, the Department interprets section 1008 to require clear
physical separation between Title X projects and places ``where''
abortion is offered as a method of family planning.
The Department agrees that educational efforts to help the general
public understand the services provided by Title X as well as those not
provided by Title X, would be beneficial and will be considered by the
Department. The Department believes that public educational efforts
could augment the requirement for physical separation and contribute to
more accurate public perception. But such efforts do not negate the
need for clear and understandable separation between Title X services
and abortion services at the clinic level. Physical separation assists
with statutory compliance, in addition to improving public perception,
by ensuring that both intentional and unintentional comingling of
resources, activities, and services do not take place in ways that are
exacerbated when both services are housed in the same space.
The final rule seeks to reduce, and potentially eliminate, any
confusion--actual or potential--as to the scope of services supported
by Title X funds by requiring funded projects to maintain clear
physical and financial program separation from programs that use
abortion as a method of family planning. The Department believes the
rule will create a clearer and more transparent system of separation
and accountability, similar to that established by the 1988 regulations
and affirmed in Rust. It will also help assure fidelity to the text and
purpose of section 1008 and facilitate auditing and enforcement of
program requirements. The rule does not, however, restrict the use of
non-Title X funds outside the Title X program, nor does it impose
restrictions on funds provided by other federal programs.
The Department disagrees with commenters who contend that, because
the Department did not have sufficient
[[Page 7766]]
opportunity after several years of litigation to put the 1988
regulations into effect before a new administration chose not to
implement them, the Department may not implement essentially the same
rules now. When the Supreme Court upheld the 1988 regulations, the
Court held it was legally permissible for the Department to put them
into effect. Nothing in the Administrative Procedure Act precludes the
Department from re-adopting regulatory provisions that it had
previously adopted, successfully defended in court, and then rescinded.
Commenters contend that the Department should have conducted more
research regarding State laws, and regulation implementation costs by
interviewing Title X providers. However, the number or administrability
of State laws cannot take precedence over the statutory requirements of
the federal Title X grant program. Additionally, the large volume of
responses submitted within the 60-day comment period verifies that this
process was sufficient for organizational and State stakeholder
responses, both of which the Department received and carefully
considered.
With respect to the contention of some commenters that the physical
and financial separation requirements will destabilize the network of
Title X providers, the Department disagrees. The rule continues to
allow organizations to receive Title X funds even if they also provide
abortion as a method of family planning, as long as they comply with
the physical and financial separation requirements. The rule also
allows case-by-case determinations on whether physical separation is
sufficiently achieved to take the unique circumstances of each program
into consideration. As is true for all program requirements, the
Department welcomes regular interaction with grantees and
subrecipients, should they have questions. Project officers are
available to help grantees successfully implement the Title X program
in compliance with both the statute and the regulation. The Department
encourages grantees to contact the program office with questions,
discuss ways to comply with the physical separation requirement, and
put a workable plan in place to meet the compliance deadline. Moreover,
the Department will not require compliance with the physical separation
requirements of Sec. 59.15 until one year after this final rule is
published in the Federal Register. This will give grantees and
subrecipients time to make arrangements to comply with physical
separation requirements if they choose to seek Title X funds (or to
participate in a Title X project) and also offer abortions as a method
of family planning. Other provisions of the rule encourage additional
entities to apply for Title X grants and additional individuals and
institutions to participate in the Title X program. If certain grantees
and/or subrecipients choose not to continue in the Title X program
because they elect not to comply with the physical separation
requirements in Sec. 59.15 in one year, the Department will be in a
position to continue to fulfill the purpose of Title X by funding
projects sponsored by entities that will comply with the physical
separation requirement and provide a broad range of family planning
methods and services to low income clients. In several locations, there
are already competing applicants to serve the same region. The
Department believes that, overall, the final rule will contribute to
more clients being served, gaps in services being closed, and improved
client care that better focuses on the family planning mission of the
Title X program.
Commenters' insistence that requiring physical and financial
separation would increase the cost for doing business only confirms the
need for such separation. If the collocation of a Title X clinic with
an abortion clinic permits the abortion clinic to achieve economies of
scale, the Title X project (and, thus, Title X funds) would be
supporting abortion as a method of family planning. Put differently,
the abortion clinic would be benefiting from the presence of the Title
X project in the same location. Moreover, it would be the participation
of the Title X project in bulk purchases and other economies of scale
that enables the abortion clinic to achieve economies of scale. Such an
argument makes the case that comingling of funds between Title X and
abortion services is difficult to avoid without a physical and
financial separation between the two.
The final rule does not prevent a woman from seeking and obtaining
an abortion. It simply draws a bright line between permissible services
provided with Title X funds and prohibited abortion services. The
Department, thus, disagrees with commenters who contend the rule should
not be finalized because women might need to make separate visits if
they seek both Title X services and abortions from a Title X provider.
Congress chose to restrict the use of Title X funding in section 1008,
and the Supreme Court held in Rust that the requirement of physical and
financial separation is not an impermissible imposition on any Fifth
Amendment right concerning abortion.
Moreover, for the reasons discussed above, the Department does not
anticipate any loss of Title X providers that will exacerbate health
inequalities or harm patient care. The Department anticipates that the
rule, overall, will contribute to more clients being served and gaps in
services being closed. In response to commenters who contend more time
is needed than the proposed 60 days to implement aspects of Sec. 59.15
other than physical separation, such as factors concerning separate
signs and other forms of identification in paragraph (d), or factors
concerning the requirement for separate electronic health care records
in paragraph (c), which commenters say would require separate
Electronic Health Record (EHR) systems, the Department disagrees. The
Department notes that EHR systems would be considered part of the
physical separation requirement. The Department found that
approximately 80% of the 4,000 Title X sites were using an electronic
practice management system in 2016, with about 70% using the more
advanced EHR system.\114\ For those with an EHR system, the
implementation of a new site within the same system should take
significantly less time than the one year provided in the final rule.
In addition, depending upon the EHR system, it may not be necessary to
acquire a new EHR license at all. While some EHR systems include
integrated administrative or financial accounting systems, that is not
the universal practice. Moreover, although some EHR systems can
generate separate financial reports, as well as a variety of other
useful information for the Title X program, current grantees should
already maintain financial separation, so whether such separation is
accomplished through an EHR system or another means, this rule should
not impose additional burden on the provider.
---------------------------------------------------------------------------
\114\ OPA, 2016 Sustainability Assessment: The Title X program
(Feb. 2017).
---------------------------------------------------------------------------
Although the proposed rule does not identify these factors as such,
factors (b)-(d) are factors that help determine whether there is
physical separation (the degree of separation from facilities;
existence of separate personnel, electronic or paper-based health
records, and workstations; and the extent to which signs and other
forms of identification of the Title X project are present, and signs
and material referencing or promoting abortion are absent).
Accordingly, the 1-year compliance date applicable to physical
separation will apply to them. Factor (a) (separate, accurate
accounting records)
[[Page 7767]]
relates to financial separation. In light of those concerns, the
Department is finalizing Sec. 59.19's transition provisions so that
the physical separation requirements of Sec. 59.15 will have a
compliance date (by which covered entities must comply with the
physical separation requirements of the section) of one year after
publication in the Federal Register. The financial separation
requirements of Sec. 59.15 will have a compliance date of 120 days
after publication in the Federal Register. During that transition
period, Title X projects will still be required to comply with the
financial separation requirements of the 2000 regulations, and
accompanying guidance that the Department has published concerning
financial separation. Title X projects may transition to compliance
with the physical and financial separation requirements of Sec. 59.15
prior to the respective compliance dates if they choose to do so.
Regarding the remaining comments, the Department rejects the
comment that it should not finalize the rule because physical
separation reinforces the notion that abortion is not a normal part of
health care. It is Congress that singled out abortion as an
impermissible activity for Title X projects when it specified that it
will not fund Title X projects where abortion is a method of family
planning.\115\ The Department is merely implementing that determination
by Congress in a legally permissible manner by determining that there
should be physical separation between Title X projects and abortion as
a method of family planning.
---------------------------------------------------------------------------
\115\ It is also Congress that prohibits the use of Title X
funds to pay for any abortions and the use of other federal funds to
pay for abortions, except in cases of rape, incest, or where the
life of the mother is endangered unless an abortion is performed.
---------------------------------------------------------------------------
The Department likewise rejects the suggestion that the rule will
impede training for residents in obstetrics and gynecology because the
rule will force abortion clinics to close. This final rule does not
require clinics that perform abortions to shut down; it only requires
that Title X programs maintain physical and financial separation from
any provision of abortion. Residents in obstetrics and gynecology will
be able to continue their training on family planning methods and
services in Title X clinics or at other clinics that provide abortion
services. Such training is not impeded by this final rule.
Although the Department takes seriously the concerns raised about
potential violence to locations where abortion services are provided,
the Department views those concerns as misplaced objections to this
rule. Congress chose not to use Title X funds to support programs where
abortion is a method of family planning, and the Department has
determined that a clear separation between Title X projects and
locations offering abortion services is the most appropriate means of
implementing that requirement. In order to comply with statutory
program integrity provisions to separate Title X funds from facilities
where abortion is a method of family planning, the Title X project
should not be intermixed with such abortion services. The Department
believes that having signs and other forms of materials referencing or
promoting abortion present together with Title X materials will confuse
the patient regarding what Title X allows. In addition, the Department
believes clinic signs must be clear in identifying Title X services
versus abortion services. All such requirements avoid confusion
regarding what are Title X services and what are not Title X services.
Congress has separately provided protections for locations offering
abortion services. See, e.g., 18 U.S.C. 248.
Title X authorizes the Secretary to promulgate regulations
governing the program. 42 U.S.C. 300a-4. The Department has exercised
this authority through regulations to guide Title X grantees in
carrying out the program. The Department disagrees with commenters who
assert that Title X programs have insufficient guidance on how to apply
the physical and financial separation requirements. The Department has
included the factors it considers for physical and financial separation
of Title X project or facility from prohibited activities in Sec.
59.15. The Department will also take individual circumstances into
consideration. For example, a Title X service site might be a hospital
that also performs some abortions. However, there is likely less chance
of confusion between the hospital's family planning services and
abortion services. There are many and diverse centers within the
hospital, often in different locations within the hospital building or
complex, with different entrances, signage, waiting rooms, and
protocols. In addition, it is highly unlikely that a Title X clinic and
abortion facilities would be collocated within a hospital building or
complex. As long as the Title X clinic and the hospital facilities
where abortions are performed are not collocated or located adjacent to
each other within a hospital building or complex, it is highly likely
that the hospital is not violating the requirement that there be
physical separation between the Title X funded activities and
activities related to abortion as a method of family planning. By
contrast, in a free-standing clinic, physical separation might require
more circumstances to be taken into account in order to satisfy a clear
separation between Title X services and abortion services. A free-
standing clinic would likely present greater opportunities for
confusion between Title X and abortion services, including, for
example, the same entrances, waiting rooms, signage, examination rooms,
and the close proximity between Title X and impermissible services.
The Department does not believe that the physical and financial
separation requirement will lead to the mishandling of patient data, as
some commenters suggest. Separate EHR systems may lead to two separate
electronic medical records, but that is no more burdensome than if the
clinic only offers specific services and the patient needs to go to a
separate clinic for other needed health care services. It is not
uncommon for people to have different health care providers for
different health care needs. If Title X services and abortion services
are separate, it is no more difficult for Title X providers to maintain
two electronic records, one for Title X services and another for
abortion services, than to keep abortion services and other services
separate within the same EHR system. Moreover, because of growing
interoperability of EHRs and other health IT, it is a simpler matter
for one provider to share a patient's EHR with another provider--thus,
any risk associated with mishandling or missing patient data should be
minimized.
Finally, the Department has considered comments on whether the rule
should also require, not just physical and financial separation between
Title X projects and programs where abortion is a method of family
planning, but also organizational separation, and/or provisions such as
a requirement that a Title X clinic must operate under a distinct name
from a facility that provides abortion as a method of family planning.
After considering all the comments and balancing the Department's need
to transition to and implement the proposals it is finalizing in this
rule, the Department has concluded that, at this time, it will not
finalize this rule to add a requirement of organizational separation or
name separation, beyond the requirement for physical and financial
separation.
[[Page 7768]]
K. Prohibition on Activities That Encourage, Promote or Advocate for
Abortion (42 CFR 59.16)
Summary of changes: In the first two sentences of proposed Sec.
59.16(a), the proposed rule would require that ``[a] Title X project
may not encourage, promote or advocate abortion as a method of family
planning. This restriction prohibits actions to assist women to obtain
abortions or to increase the availability or accessibility of abortion
for family planning purposes.'' The Department finalizes the title and
first two sentences of proposed Sec. 59.16(a) as Sec. 59.16(a)(1),
with a change to clarify, in response to comments, that the
prohibitions apply in the Title X project, not to a grantee's or
subrecipient's activities outside of the Title X project and with
respect to abortion as a method of family planning, as explained above
in response to comments discussed in the section of the preamble
addressing Sec. 59.14(a).
The proposed third sentence, and paragraphs (a)(1) through (6), of
Sec. 59.16 would specify that the prohibitions include various
activities. Paragraph (b) gives examples to illustrate how the proposed
prohibitions and specific items listed in Sec. 59.16(a) would apply.
The Department finalizes the third sentence, and paragraphs (a)(1)
through (5), of Sec. 59.16 without change, except for formatting
changes to improve readability, as Sec. 59.16(a)(2)(i) through (v).
The Department finalizes paragraph (a)(6) of the proposed rule in Sec.
59.16(a)(2)(vi), as modified in response to comments. The Department
finalizes Sec. 59.16(b)(2) and (3) with changes for clarity in
response to comments, as discussed below, and otherwise finalizes Sec.
59.16(b) without change.
Comments: In the discussion of Sec. 59.14(a), the Department
addressed comments concerning prohibitions on referral for, and
encouragement, promotion, advocacy, support, and assistance of
abortion. The Department does not repeat those comments and responses
here to the extent they overlap with the comments concerning the
specific actions listed in paragraphs (a)(1) through (6) of Sec.
59.16, or the examples explained in paragraph (b).
The Department received various and conflicting comments about its
legal authority to enact this section. Some commenters argue the
Department is exceeding its statutory authority by impermissibly
limiting providers' non-Title X activities and by limiting speech and
activities by defining such activities as lobbying. Some of these
commenters assert the Department does not adequately explain why the
prohibitions on advocacy, lobbying and political activities are
justified, stating that it is unreasonable to impose the cost of
complying with the proposed rule with no justification. Other
commenters contend the proposed rule sufficiently protects free speech
by prohibiting the encouragement, promotion or advocacy of abortion by
Title X projects but not outside of those projects. These commenters
further defend the proposed rule on First Amendment grounds by
supporting the Department's rescission of the paragraph in Sec. 59.5
that required Title X providers to counsel on, and refer patients for,
abortion.
Some commenters state that the proposed language in Sec. 59.16 is
vague, making it difficult to discern what is permissible under the
proposed rule, causing confusion, and leading to a prohibitory effect
on activities paid for with non-Title X funds. Some of those commenters
state that the vagueness may lead to decreased participation in the
program or the exclusion of qualified providers, reducing access to
care for many patients. Some commenters contend that, to comply with
the restriction not to pay affiliation dues or disseminate materials
with non-Title X funds, grantees would need separate facilities, and
this would lead to the isolation of family planning centers that
receive Title X funding, limitations on access, and decreases in the
quality of care.
Other commenters oppose the section as unnecessary, arguing that
Title X grantees already receive sufficient guidance on what is and is
not a permissible use of funding, and that the Department has power
without this rule to remedy any findings of noncompliance.
Still other commenters support the proposed rule, and assert that
the Department should add additional activities to Sec. 59.16,
activities that would be considered as promoting abortion. They ask the
Department to provide a wider list of prohibited activities in order to
avoid confusion. One commenter provided a list of additional activities
that should be prohibited.
Multiple commenters express concern about the proposed rule's
impact on State law. For example, commenters write that Sec. 59.16 is
not consistent with California's Reproductive Privacy Act and Healthy
Youth Act. Some commenters contend that, in New York, organizations
that can apply for funding through Title X are already prohibited from
funding or engaging in any kind of lobbying activities, rendering this
section unnecessary.
Response: As noted above, the Department has slightly modified
Sec. 59.16(a) to more clearly explain it applies to actions undertaken
within the Title X project, not actions and speech undertaken by Title
X grantees (and subrecipients) outside the Title X project. This, and
the discussion above, of the Supreme Court's rejection of First
Amendment challenges to the 1988 regulations, which had substantially
the same provisions, adequately addresses commenters concerns that
Sec. 59.16 fails to adequately protect free speech. The Department
clarifies again that nothing in this rule restricts the use of non-
Title X funds.
In Rust v. Sullivan, the Supreme Court upheld similar regulations
``broadly prohibit[ing] a Title X project from engaging in activities
that `encourage, promote or advocate abortion as a method of family
planning.'' Rust, 500 U.S. at 180. As in this rule, the general
prohibition was followed by a list of prohibited activities that
included, with respect to abortion as a method of family planning,
``lobbying for legislation that would increase [its] availability,''
``developing or disseminating materials advocating'' it, ``providing
speakers to promote'' it, ``using legal action to make [it] available
in any way,'' and ``paying dues to any group that advocates'' it. Id.
The Court concluded a prohibition on such activities is within the
Secretary's discretion in implementing section 1008. Id. at 184-87. The
Court further concluded such conditions did not violate either free
speech principles under the First Amendment, or women's rights under
the Fifth Amendment. Id. at 192-200, 200-203.
The Department concludes that Sec. 56.16 of the final rule does
not violate the First Amendment's protections for the same reasons that
the Supreme Court held that the 1988 regulations withstood First
Amendment challenges in Rust. Both this rule and the rule upheld in
Rust entail the same basic prohibition on encouraging, promoting, and
advocating abortion as a method of family planning within the scope of
the Title X project, while leaving Title X providers free to undertake
any activity they desire outside the scope of the Title X project. This
rule contains many of the same illustrations of activities that fall
within the prohibition. The list of activities included in the 1988
regulations was non-exclusive, using the same language set forth in
this final rule that ``[p]rohibited actions include'' various specific
activities. The proposed rule adds some additional examples to those
set forth in the 1988 regulations, namely the development of materials
[[Page 7769]]
that promote a favorable attitude towards abortion, a reference to web-
based materials in that context, and the addition of ``educators'' to
the prohibition on ``speakers'' that promote abortion as a method of
family planning. Those examples are well within the reasoning of Rust,
and indeed within the broad prohibition of the 1988 regulations.
However, the Department is removing the phrase regarding a prohibition
on the use of Title X funds for the production of materials that
``promote a favorable attitude towards abortion.'' The Department makes
this change in acknowledgement of some of the commenters who contend
the section is vague and subjective, so that it would be difficult for
grantees to know what would be a permitted activity and what would
constitute an impermissible activity. The Department agrees that the
phrase is vague, and believes that prohibiting materials that promote
abortion as a method of family planning is clear and sufficient. This
final rule also includes some examples prohibiting project funds from
being used on lobbying, specifically the use of project funds for
attendance at events and conferences where the grantee or subrecipient
engages in lobbying, and the restriction on payment of dues to a group
that does not separately collect and segregate funds used for lobbying
purposes. These clauses implement the specific Congressional
prohibition that Title X project funds ``shall not be expended for any
activity (including the publication or distribution of literature) that
in any way tends to promote public support or opposition to any
legislative proposal or candidate for public office.'' \116\ As
proposed, Sec. 59.16(a)(4) would prohibit ``[p]aying dues to any group
that, as a more than insignificant part of its activities, advocates
abortion as a method of family planning and does not separately collect
and segregate funds used for lobbying purposes.'' The Department
considers this provision concerning lobbying to be an appropriate
measure to implement Congress's prohibition on the use of Title X funds
``in any way'' for lobbying. \117\ As noted above, the Department
finalizes this text, and makes corresponding changes to the examples in
Sec. 59.16(b)(2) and (3).
---------------------------------------------------------------------------
\116\ See Omnibus Consolidated Rescissions and Appropriations
Act, 1996; HHS Appropriations Act 2019, Public Law 115-245, Div. B,
132 Stat at 3071.
\117\ Title X funds ``shall not be expended for any activity
(including the publication or distribution of literature) that in
any way tends to promote public support or opposition to any
legislative proposal or candidate for public office.'' HHS
Appropriations Act 2019, Public Law 115-245, Div. B, 132 Stat. at
3071.
---------------------------------------------------------------------------
The Department appreciates commenters' suggestions of additional
activities that should be included in Sec. 59.16(a) as actions that
cannot be undertaken in Title X projects, but declines to add to the
list of actions in Sec. 59.16(a). The regulatory text indicates that
the list is non-exhaustive and that prohibited actions ``include'' the
actions listed; it does not indicate that those actions listed are the
only actions that fall under the prohibition on encouragement,
promotion, or advocacy of abortion as a method of family planning.
The Department disagrees with commenters who contend the provisions
will have the effect of pushing providers out of the Title X program,
and, therefore, that Sec. 59.16 will have a negative impact on access
to care. Much of Sec. 59.16 merely implements the applicable
appropriations law provisions; thus, Title X projects should not
currently be using Title X funds to engage in such activities. To the
extent that Sec. 59.16 incorporates new requirements, the Department
concludes that the articulation of those requirements in rulemaking
after notice and public comment is an appropriate approach to ensure
consistency and compliance with the parameters applicable to Title X.
But in any event, nothing in the final rule precludes entities that
encourage, promote, or advocate abortion from being grantees or
subrecipients, if such activities are undertaken outside the scope of
the project and consistent with the physical and financial separation
requirements of these rules. Because section 1008 precludes projects
where abortion is a method of family planning, if entities are
encouraging, promoting, or advocating such abortions within a project,
they are diverging from the goals of Title X. By ensuring that Title X
project funds are not diverted to activities that encourage, promote or
advocate abortion as a method of family planning, or that assist women
to obtain abortions for family planning purposes or to increase the
availability or accessibility of abortion, the Department anticipates
that more project funds will be available to provide the family
planning services that Congress intends in its focused approach to
Title X's scope.
The Department does not agree that this rule inadequately considers
the requirements of State laws. The rule represents implementation of a
clear choice by Congress not to fund certain activities in Title X
projects. Applicants for Title X funding will need to maintain an
awareness regarding State and local laws to which they are subject, as
well as the requirements to which they are subject under this final
rule.
The Department finalizes the example in Sec. 59.16(b)(2) with a
clarifying change. The proposed rule provided a proposed example that
established a Title X project violates paragraph 59.16(a) if it makes
an appointment with an abortion clinic for a pregnant client. The
Department clarifies this example to be more consistent with section
1008 of the PHS Act, which prohibits funding a Title X project where
abortion ``is a method of family planning.'' Consistent with that
language, as noted above and in the second sentence of Sec. 59.16(a),
the provisions of this rule implementing section 1008 apply to
``abortion for family planning purposes.'' Therefore the Department
finalizes the example listed in Sec. 59.16(b)(2) to specify that the
scenario in question is one where ``[a] Title X project makes an
appointment for a pregnant client for an abortion for family planning
purposes . . .'' The Department also makes a change to the example in
Sec. 59.16(b)(3), so that it illustrates more directly the activity
prohibited in Sec. 59.16(a)(2)(iv), by incorporating into the example
information about whether the lobbying funds were separately collected
and segregated.
L. Compliance With Reporting Requirements (42 CFR 59.17)
Summary of changes: The proposed rule would add Sec. 59.17, which
imposes requirements concerning compliance with State and local laws
requiring notification or reporting of child abuse, child molestation,
sexual abuse, rape, incest, intimate partner violence (IPV) or human
trafficking. The Department finalizes this section with changes in
response to public comments to clarify notification, screening of
minors, and recordkeeping relating to minors; and to expand related
topics to be covered in annual staff training.
Comments: Some commenters express support for increased compliance
requirements of Sec. 59.17(a) and contend that providing evidence of
compliance with all State and local laws would strengthen protection
for minors and vulnerable adult populations. Some argue that some Title
X entities enable sexual exploitation by failing to institute
compliance procedures with State and local laws that would help
victims, and they request an investigation into Title X entities to
determine the extent of failed abuse reporting. Several commenters
favor expanding reporting requirements to include reporting of general
criminal conduct unrelated to acts of sexual abuse.
[[Page 7770]]
Many commenters state that the proposed rule wrongly gives the
Department compliance oversight over State and local reporting laws.
Several commenters contend that mandated reporting of intimate partner
violence (IPV) would prevent patients from speaking candidly with
health care providers for fear that their abuse will be reported before
they have had the opportunity to protect themselves (and their
children, if applicable) financially, legally, and physically from
their abusers. Commenters mention that medical records documenting IPV
and other abuse issues can be used in legal contexts, putting patients
at risk for further violence.
Many commenters note the complexity and variety of State and local
reporting laws. Several commenters emphasize that there must be a
balance between the protection for victims of abuse, complying with
State laws, and trust in the patient-provider relationship. Several
commenters note that State laws already include specific requirements
that provide clear direction to health professionals regarding their
obligations to report and their responsibility to exercise discretion.
One commenter argues that federal and state laws should support
physicians in their clinical judgment. Other commenters contend that
allegations of providers avoiding reporting responsibilities are
without evidence and should not be a basis for policy-making.
In reply to the Department's request for comment on whether a
referral agency (to which a Title X project refers) should be subject
to the same reporting requirements as a grantee or subrecipients
subject to Sec. 59.17, some commenters state there is no need for a
referral agency to be subject to the same reporting requirements as a
grantee or subrecipient. Several commenters state that community
partners and referral agencies are not Title X funded entities, are
often overburdened and additional requirements may cause referral
agencies to terminate collaborative relationships rather than comply
with the new reporting requirements, thereby reducing patients' access
to health care.
Some commenters contend that Department enforcement of the
provisions of Sec. 59.17(b), including the threat of revocation of
funding based on whether providers comply with State and local
reporting requirements, would increase pressure on Title X projects to
over-report abuse and to engage in ``excessive policing,'' thus
traumatizing patients through interrogative questioning. They also
contend the rule would erode patient-provider trust, put patients at
risk for serious harm, re-victimize patients that have experienced
trauma, stigmatize patients that are sexually active, and negate
personal agency for adolescents.
Many commenters contend that mandatory screening raises issues
regarding confidentiality for adolescents and minors, noting that the
Title X protections for patient confidentiality are some of the
strongest under current law.
A few commenters mention that the proposed rule would result in
increased cost for screening and reporting, specifically noting the
transition to electronic health record templates. A few commenters note
that this would lead to decreased care and family planning options for
patients, resulting in increased costs for unintended pregnancies.
Many commenters fear, in particular, that screening minors with a
sexually transmitted disease (STD), pregnancy, or suspicion of abuse
would be harmful to patients and detrimental to the provider-patient
relationship, compromising trust and honesty in consultations. Many
argue that mandated screening would shift the provider role to that of
an interrogator, making young people less likely to reveal abuse, and
making them less likely to return to the Title X facility. One
commenter argues that the age of a teenager's sexual partner does not
have bearing on family planning services. Others contend that mandatory
screening would deter patients from seeking family planning services
and treatment for STDs, resulting in increased pregnancy and STDs.
Other commenters assert that screening should only be required for
patients that show signs of abuse. Commenters argue that the screening
is unnecessary, as Title X grantees already are mandated to adhere to
Federal and State notification requirements. Some commenters note that
the proposed rule may conflict with Medicaid coverage, which permits
confidential family planning services for individuals of childbearing
age, suggesting that it creates confusion as to who must be screened.
Several commenters support a commitment to confidentiality, but
also support the new rules as an important safeguard for minors who may
be the victims of sexual abuse. One commenter recommends that projects
be required, rather than permitted, to diagnose, test for, and treat
STDs.
Finally, some commenters describe instances in which they claim the
language of the proposed rule is confusing. For example, they contend
that required screening for patients ``under the age of consent in the
State'' is inconsistent with the requirement for Title X projects to
implement a plan committing to preliminary screening of teenagers with
a sexually transmitted disease (STD), pregnancy, or any other suspicion
of abuse. Such commenters suggest the language be re-written to clarify
the intent.
Response: The Department agrees with commenters who voice support
for Sec. 59.17 to ensure those vulnerable to abuse are protected in
Title X projects. The Department takes seriously the duty of Title X
grantees and subrecipients to comply with State and local laws
requiring notification or reporting of child abuse, child molestation,
sexual abuse, rape, incest, intimate partner violence, and human
trafficking. Congress has specifically emphasized the importance it
attaches to compliance with such laws by Title X funding recipients. As
stated in the most recent appropriations act, ``[n]ot withstanding any
other provision of law, no provider of services under Title X of the
PHS Act shall be exempt from any State law requiring notification or
the reporting of child abuse, child molestation, sexual abuse, rape, or
incest.'' \118\ The Department interprets that direction to include
State or local laws respecting intimate partner violence (IPV) and
human trafficking. In addition, the Secretary has authority under
section 1006 of Title X to issue regulations governing grants and
contracts in the Title X program. Thus, to ensure compliance with this
Congressional mandate, the Department believes it is appropriate to
include specific regulatory requirements with respect to the care and
treatment of survivors of child abuse, child molestation, sexual abuse,
rape, incest, intimate partner violence and human trafficking within
the context of the provision of family planning services, and the
reporting or notification of such criminal acts under State and local
notification laws in Sec. 59.17. The Department disagrees with
commenters who assert that the Department does not have the authority
to oversee compliance with reporting the listed crimes by Title X
providers in Title X projects.
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\118\ HHS Appropriations Act 2019, Public Law 115-245, Div. B,
sec. 208, 132 Stat. at 3090.
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The Department understands the sensitivity that comes with IPV, but
concludes that, if a State or local jurisdiction has enacted laws to
require reporting of IPV by entities that are Title X grantees or
subrecipients, it is appropriate for the Department to ensure that such
entities comply with
[[Page 7771]]
those laws as a condition of receiving Title X funds. Title X providers
may be the first health care touchpoint for the survivors of IPV. As
such, they should be prepared and trained not only to treat such
individuals with dignity and care in addressing such individuals'
family planning needs, but also to refer them for other needed health
care and to report such IPV to the appropriate authorities. State and
local reporting laws that include IPV do so, among other reasons,
because of its connection to poverty, because most IPV victimizes
women, and because intimate partner homicides make up 40% to 50% of all
murders of women in the United States.\119\ Moreover, IPV may include
rape, sexual abuse, and/or other crimes expressly addressed in the
Title X appropriations provision. The Department considers these
reasons sufficient to include IPV in the reporting requirements of this
rule.
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\119\ Office of Justice Programs, Causes and Consequences of
Intimate Partner Violence, National Institute of Justice (Oct. 24,
2007), https://www.nij.gov/topics/crime/intimate-partner-violence/Pages/causes.aspx.
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The Department acknowledges that complying with State and local
laws may be complicated, and for that reason Title X grantees and
subrecipients must have in place a plan that ensures that the grantee
and any subrecipients are aware of what specific reporting requirements
apply to them in their State (or jurisdiction), and provide adequate
training for all personnel with respect to these requirements and how
such reports are to be made. The complexity of those laws is not an
excuse for non-compliance, and the Department will not tolerate Title X
grantees and subrecipients failing to comply with the reporting
requirements that State and local governments have seen fit to enact as
binding legal requirements. The proposed rule at Sec. [thinsp]59.17
defers to State and local jurisdictions on what reporting requirements
apply, and in this way fully respects Federalism and the proper
jurisdiction over such crimes that is exercised by State and local
governments. The proposed rule does not add any substantive reporting
requirement that State and local jurisdictions do not already impose;
the rule simply ensures that the Title X grantees and subrecipients are
in compliance with federal law by ensuring that such grantees and
subrecipients are in compliance with State and local reporting
requirements.
As several commenters note, State and local laws can be vital
resources in crafting protocols since they often provide direction to
health professionals regarding how to balance their obligations for
reporting with the exercise of discretion to best protect the safety of
the victim. As part of prevention, protection, and risk assessment
efforts, grantees and subrecipients should include compliance protocols
to identify individuals who are victims of sexual abuse or who are
targets for underage sexual victimization, as well as to ensure that
every minor who presents for treatment is provided counseling on how to
resist attempts to coerce them into engaging in sexual activities (as
required by appropriations law applicable to Title X).
The Department believes that increased compliance requirements
strengthen protection for minors and other vulnerable populations. The
proposed rule, and this final rule, at Sec. [thinsp]59.17 explicitly
address the requirement for Title X projects to comply with all State
and local laws regarding the notification or reporting of crimes
involving sexual exploitation, child abuse, child molestation, sexual
abuse, rape, incest, intimate partner violence, and human trafficking
(collectively, ``State notification laws''). The Department's Office of
Inspector General (OIG) issued a 2005 report revealing that even though
OPA informs and periodically reminds Title X grantees and subrecipients
of their responsibilities regarding State child-abuse and sexual-abuse
reporting requirements, it could not determine the extent to which
grantees actually comply with these requirements.\120\ The Department
believes that minors and other vulnerable communities are better served
if Title X providers are accountable for complying with these State and
local laws.
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\120\ HHS OIG, OEI-02-03-00530, Letter on Federal Efforts to
Address Applicable Child Abuse and Sexual Abuse Reporting
Requirements for Title X Grantees (Apr. 25, 2005), https://www.hhs.gov/opa/sites/default/files/child-abuse-reporting-requirements.pdf.
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The Department is also sensitive to concerns raised by commenters
that victims of abuse are sometimes repeatedly victimized after abuse
is reported. Therefore, the Department expects grantees and
subrecipients to include additional training in their protocols to
assist counselors with their interactions with a victim of abuse and to
ensure that they are equipped to make referrals that increase the
safety of the patient. The regulatory text is updated to reflect this
additional component of training for Title X staff in paragraph
(b)(1)(ii) of Sec. 59.17. The final rule adds that the policies will
include training regarding State notification laws and ``appropriate
interventions, strategies, and referrals to improve the safety and
current situation of the patient. . . .''
The Department has considered the request of some commenters to
broaden the reporting requirements even further. The Department
concludes, however, that the proposed language is consistent with
language that has been included in appropriations acts for the
Department since fiscal year 1999.\121\ Additionally, the Department
has considered some commenters' requests to further investigate the
specific entities which the commenters allege have misappropriated
Title X funds. The Department believes that the clarification of
reporting requirements found in the rule will remedy any confusion
about the use of Title X funds. The Department will investigate any
credible report of fiscal abuse or misuse of funds and take appropriate
action, if found.
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\121\ See, e.g., Department of Health and Human Services
Appropriations Act, 1999, Public Law 105-277, Title II, sec. 219,
112 Stat. 2681, 2681-363 (1998).
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Having considered the comments about whether to broaden the
reporting requirements to include entities that are not grantees or
subrecipients, such as referral agencies, the Department agrees with
commenters who state that referral partners should not be subject to
the same reporting requirements. Referral agencies do not receive Title
X funds, therefore, the Department declines to make changes in Sec.
59.17 that would expand the provision to impose reporting requirements
on entities that are neither recipients nor subrecipients of Title X
funds.
The Department disagrees with commenters who say the training and
reporting requirements in the proposed rule will lead to over-reporting
or erode patient trust and confidentiality. Title X grantees and
subrecipients are already subject to State and local reporting laws,
and Congress has made it clear that the receipt of Title X funds does
not permit Title X grantees and subrecipients to avoid such
obligations. In addition, Sec. 59.11 of the 2000 regulations permits
the use of confidential information obtained by project staff to comply
with State and local reporting requirements. The Department will not
second guess the determinations of States or local governments that
these reporting requirements do not erode patient trust and
confidentiality, but protect vulnerable persons. The Department is not
aware of compelling evidence to the contrary from commenters. The
Department also hopes that victims of
[[Page 7772]]
abuse will feel increased trust with Title X providers as a result of
the training required in the final rule, not only with respect to
compliance with State and local reporting laws, but also how to offer
strategies to improve the victim's current situation, including the
patient's safety.
The Department disagrees with commenters who assert the regulations
will abrogate confidentiality for minors, stigmatize them, cause them
to lose their personal agency, or violate their informational privacy
rights. All recordkeeping, except that which must be submitted as a
result of mandatory reporting, is subject to the same confidentiality
requirements as other medical services rendered by the clinic. If a
minor is a suspected victim of abuse, the Title X provider has the
obligation to report suspected abuse,\122\ make appropriate referrals
if needed, and empower the minor with skills to build self-efficacy and
the self-confidence to resist any future sexual coercion.\123\
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\122\ As Representative Ernest Istook said during the debate
regarding the provision: ``It says, if there is a situation, such as
I described, involving an underage child, Title X providers must
report that and comply with State law the same as anyone else who
deals with services to our young people.'' 143 Cong. Rec. H7053
(daily ed. Sept. 9, 1997).
\123\ HHS Appropriations Act 2019, Public Law 115-245, Div. B,
sec. 207, 132 Stat. at 3090.
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The Department disagrees with some commenters who contend the age
of a minor's sexual partner has no relevance for Title X grantees.
State and local reporting laws concerning sexual abuse or child abuse
often have elements concerning the age of the minor and the minor's
sexual partner. Title X exempts neither Title X providers nor Title X
health care providers from their responsibility to comply with State
and local reporting laws. Child abuse, child molestation, sexual abuse,
rape, incest, intimate partner violence, and human trafficking are
crimes that affect individuals, families, and communities. Title X
projects should be the exemplar of an appropriate model for protecting
those who are vulnerable to sexual abuse, rape, and assault; in
developing protocols to identify clients who may be at risk for sexual
abuse; in counseling teens on, and in producing programs and materials
that assist teens in, resisting sexual exploitation, abuse, and
coercion; \124\ and in assuring appropriate support and management of
teens (and women and men) who have been exploited, abused or coerced
into unequal sexual partnerships. The Department believes asking the
right questions can identify victims of abuse for mandatory reporting
purposes, protect them from continued victimization, and help them
access services to increase their health and safety in the future. With
regard to comments concerning the requirement in Sec. 59.17(b)(2)(ii)
to maintain records including those which ``[i]ndicate the age of the
minor client's sexual partners where required by law,'' the Department
clarifies what is meant by that paragraph by finalizing it to read,
``[i]ndicate the age of the minor client's sexual partners if such age
is an element of a State notification law under which a report is
required. . . .'' The Department does not believe that conforming to
the reporting requirement will result in a regulatory burden or
increased costs for reporting to State and local authorities, since
grantees and subrecipients should already be complying with this
mandate.
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\124\ As noted above, the annual appropriations laws also impose
on Title X grantees the obligation to provide ``counseling to minors
on how to resist attempt to coerce minors into engaging in sexual
activities.'' See HHS Appropriations Act 2019, Public Law 115-245,
Div. B, sec. 207, 132 Stat. at 3090.
.
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The Department disagrees that required sexual abuse/victimization
screenings are harmful to patients. Similar to typical components of a
medical history, Title X projects are already required to conduct a
preliminary screening of any teen who presents with an STD, pregnancy,
or suspicion of abuse in order to rule out victimization of a minor.
Such screening is required with respect to any individual who is under
the age of consent in the jurisdiction in which the individual receives
Title X services. If positively diagnosed, projects are permitted to
treat STDs as an appropriate preconception service. The requirement in
the final rule is more explicit in the age parameters in order to offer
consistency from State to State and to ensure that this requirement
consistently applied throughout all Title X services areas. This
requirement is responsive to both State notification laws as well as
the appropriations rider related to sexual coercion of minors. The
Department does not believe, as some commenters suggest, that Title X
providers should be required to diagnose, test for, and treat STDs,
although testing and treatment would be an appropriate referral
service, if not offered onsite. Sites must offer a variety of family
planning services, but are not required to provide all such services.
As an important component of the screening process, staff would
sensitively converse with patients and build trust, while obtaining the
information needed to comply with the screening and reporting
requirements.
The Department disagrees with commenters who assert the rule
conflicts with Medicaid coverage confidentiality requirements. The rule
requires screening for minors who are pregnant or test positive for
STDs. The preliminary screening is used to determine whether the minor
is a likely victim of sexual coercion, a concern of Congress, as
evidenced by its specific mandate that Title X projects provide
``counseling to minors on how to resist attempts to coerce minors into
engaging in sexual activities.'' \125\ While Medicaid and Title X both
allow family planning services to be provided confidentially to
individuals of childbearing age, providers serving patients who use
Medicaid must still do their due diligence to ensure they are complying
with all State and local reporting requirements, and if Title X
grantees, with the appropriations riders applicable to the program. In
light of State and local laws against incest and laws regulating age-
specific requirements for permitting sexual relations with minors, the
Department believes that mandatory screening of minors ensures that
Title X providers are adequately assessing their legal requirements
under State and local law, the protection to minors sought in the
appropriation rider, and the patient's overall health. The Department
is specifically directed to focus Title X grantees on these issues:
Appropriations law provisions requires Title X applicants to certify
that it ``provides counseling to minors on how to resist attempts to
coerce minors into engaging in sexual activities'' \126\ and requires
Title X providers to comply with State notification or reporting laws
on child abuse, child molestation, sexual abuse, rape, or incest. The
confluence of these two separate, but related, mandatory provisions are
addressed in this Section.
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\125\ Departments of Labor, Health and Human Services, and
Education, and Related Agencies Appropriations Act, 1998, Public Law
105-78, sec. 212, 111 Stat. 1467, 1495; HHS Appropriations Act 2019,
Public Law 115-245, Div. B, sec. 207, 132 Stat. at 3090.
\126\ Departments of Labor, Health and Human Services, and
Education, and Related Agencies Appropriations Act, 1998, Public Law
105-78, sec. 212, 111 Stat. 1467, 1495; HHS Appropriations Act 2019,
Public Law 115-245, Div. B, sec. 207, 132 Stat. at 3090.
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The Department disagrees with commenters who assert only those with
visible signs of abuse should be screened or that screening is
unnecessary. Pregnancy, or the presence of an STD, can be evidence of
abuse or a predictive sign of abuse, especially among younger minors.
Often victims
[[Page 7773]]
do not self-identify and may have no obvious indicators at all,
elevating the necessity of screening. The Department believes that a
confidential and empathetic screening process will enable a program to
better serve those individuals who have been victimized and to identify
those instances where state or local law requires notification of
certain crimes.
The Department agrees with some commenters who observe that the
language of the proposed rule is inconsistent in referring to a
``minor'' several times, an individual below the ``age of consent'' in
another place, and to a ``teen'' in the first part of the first
sentence of Sec. 59.17(b)(1)(iv). The Department intended the rule to
refer to ``minors'' in all such instances, and finalizes Sec.
59.17(b)(1)(iv) to change the word ``teen'' to ``minor;'' and to remove
the sentence referencing ``age of consent'' in relation to State laws,
since preliminary screening for minors would be separate from, but
inclusive of, ages included in individual State notification laws.
Although Sec. 59.17(a) defines the term ``State notification
laws'' for the purposes of the section to refer collectively to ``all
State and local laws requiring notification or reporting of child
abuse, child molestation, sexual abuse, rape, incest, intimate partner
violence or human trafficking'', the prefatory text of Sec.
59.17(b)(1) mistakenly uses the phrase ``State laws'' instead of
``State notification laws.'' The Department therefore finalizes Sec.
59.17(b)(1) prefatory text to change the phrase ``State laws'' to
``State notification laws,'' consistent with the intent of the proposed
rule.
M. Appropriate Use of Funds (42 CFR 59.18)
The 2000 regulations required that any Title X funds must be
expended solely for the purposes for which the funds were granted. The
proposed rule would add Sec. 59.18, which clarifies this language by
detailing the prohibited uses of Title X funds, including their use for
abortion-related infrastructure building, lobbying activities, and any
other possible misuse of funds. The Department finalizes the section
without change, except to make technical edits that improve
understanding and readability.
Comments: Many commenters that object to Sec. 59.18's proposed
prohibition on uses for Title X funds, including limits on
infrastructure building, and raise objections that overlap with their
objections to the proposed requirements of Sec. 59.15 for physical and
financial separation of Title X projects and prohibited activities. The
Department's response to those comments above encompasses those
objections.
Some commenters support the proposed language of Sec. 59.18
prohibiting the use of Title X funds for building infrastructure that
supports a Title X grantee's abortion-related activities. Commenters
state that the proposed changes will help ensure that Title X funds are
correctly appropriated. Others believe the rule should go further and
require grantees or subrecipients to demonstrate that they do not fund
abortion services with Title X funds.
Some commenters contend it is unnecessary for the Department to
prohibit the use of Title X funds to support abortion services,
infrastructure building for that purpose, or lobbying. They contend
current accounting, reporting, and auditing requirements already ensure
that each Title X project fully accounts for and justifies charges
against the Title X grant.
Response: The Department agrees with commenters who support the
proposed language at Sec. 59.18.
The Department disagrees with commenters who suggest that there
have been no concerns raised regarding improper use of Title X funds.
The Department believes that, even if the extent of such misuse of
funds is not fully known, the Department is still legally obliged to
ensure funds are not misused, so it is appropriate for the final rule
to identify what constitutes such misuse of Title X funds. Increased
transparency will ensure greater accountability for the use of Federal
funds and will mitigate confusion about what services the federal
government supports and funds.
As explained in the proposed rule, the flexibility in the use of
Title X funds under the 2000 regulations raises concerns about the
fungibility of assets that could be used to build infrastructure for
abortion services. By law, Title X providers must secure other sources
of revenue to leverage Title X grants. 42 CFR 59.7(c) (``No grant may
be made for an amount equal to 100 percent for the project's estimated
costs.''). Medicaid providers are reimbursed by States for allowable
expenditures. By their very nature, grants afford considerably greater
latitude and versatility to grantees on how funds are used. If an
organization receives both Medicaid and Title X funding, for example,
Medicaid reimbursement payments might be used to cover many family
planning services, freeing up Title X funds to be used for
infrastructure-building and support. In its Moving Forward: Family
Planning in the Era of Health Reform report, the Guttmacher Institute
reported that providers do in fact use Title X funds in this way:
Up-front funding helps supply a cash-flow cushion for providers
who are often operating on tight and uncertain budgets. More
specifically, Title X grantees use the program's flexible grant
funding in a variety of ways to address staff-related issues,
including hiring individuals capable of meeting communities' need
for linguistic or culturally appropriate care, training staff on the
latest medical techniques or to provide tailored counseling for
clients with special needs, maintaining sufficient staff to operate
outside regular business hours and paying sufficient wages to staff
at all levels to reduce high turnover rates that often plague health
centers. Providers may also use Title X funds for operational
investments, such as utilizing advanced technologies and
facilitating more accessible and efficient client care . . . .
Finally, Title X undergirds the infrastructure and general
operations of the health centers themselves in ways that Medicaid
and private insurance simply cannot. Title X funds go to centers up
front as grants, rather than after the fact as reimbursement for
services centers have provided to individual enrollees. Providers
have long relied on that flexibility to hire, train and maintain
their staff to meet the diverse needs of their clients and
community. They have also depended on these grants to keep their
lights on and their doors open, to adapt to unexpected budget
shortfalls and to make improvements to their facilities. Such
versatility is even more vital in the era of health reform. The up-
front investments in staffing, training and infrastructure needed to
work effectively with health plans--and to thereby draw in new
revenue to serve more clients--are substantial, and flexible funds
like those provided through Title X are ideal for such investments.
Those expenses include upgrading health information technology
systems and training staff on their use, training clinicians and
front-line staff to properly code and bill for services provided,
obtaining the appropriate credentials to ensure third-party
reimbursement, and devoting time and resources to researching
available health plans and negotiating contracts with them. They may
also include expenses related to outsourcing some administrative
functions to private contractors or as part of collaborations with
other health care providers.\127\
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\127\ Sonfield, A., Hasstedt, K., Gold, R.B., Moving forward.
Family planning in the era of health reform, Guttmacher Institute 30
(March 2014), https://www.guttmacher.org/report/moving-forward-family-planning-era-health-reform.
In a 2007 report, Guttmacher expanded upon the infrastructure
---------------------------------------------------------------------------
support afforded by Title X funding:
Title X can subsidize the intensive outreach necessary to
encourage some individuals to seek services. Furthermore, by paying
for everything from staff salaries to utility bills to medical
supplies, Title X funds provide the essential infrastructure support
that enables clinics to go on and claim
[[Page 7774]]
Medicaid reimbursement for the clients they serve.\128\
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\128\ Gold, R.B., Stronger Together: Medicaid, Title X Bring
Different Strengths to Family Planning Effort, Guttmacher Institute
15 (May 17, 2007), https://www.guttmacher.org/gpr/2007/05/stronger-together-medicaid-title-x-bring-different-strengths-family-planning-effort.
Infrastructure building may include securing physical space,
developing or acquiring health information technology systems
(including electronic health records), bulk purchasing of
contraceptives or other clinic supplies, clinical training for staff,
and community outreach and recruiting. An anecdotal story \129\ from
the 2007 report reinforces the point:
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\129\ Id. at 17.
Ibarra of California's Venice clinic says her agency sends
street outreach teams into the community with backpacks of condoms
and basic educational materials, while other teams make regular
visits to homeless shelters. Often, it will take multiple visits to
a shelter or street-corner conversations until someone feels safe
enough to come to a clinic. According to Ibarra, Title X will fund
and train the outreach workers, purchase the condoms and often even
develop the educational materials they distribute. Only when a
client actually comes to the clinic is reimbursement available
(through Medicaid or any other source), and then only if the client
qualifies. According to Annette Amey, director of program evaluation
for CFHC, ``it's all about getting people to the inside of the
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clinic door, and for that Title X dollars are indispensable.''
The Department is concerned about this infrastructure building on
both statutory and policy grounds. As a statutory matter, the use of
Title X funds to build infrastructure that can be used for purposes
prohibited with these funds, such as support for the abortion business
of a Title X grantee or subrecipient, clearly violates section 1008. As
a policy matter, Title X is the only discrete, domestic, Federal grant
program focused solely on the provision of cost-effective family
planning methods and services. As the number of Americans at or below
the poverty level has increased, the need to prioritize the use of
Title X funds for the provision of family planning services has as
well.
The Department concludes it is appropriate to implement the
statutory requirements applicable to Title X by imposing the Sec.
59.18 restrictions addressing the use of Title X funds for
infrastructure purposes related to abortion, particularly in
combination with the Sec. 59.15 requirement of physical and financial
separation of Title X projects from prohibited activities (e.g.,
abortion as a method of family planning). Because Title X projects
would not share any infrastructure with abortion-related activities,
direction of Title X funds toward such infrastructure would no longer
threaten to divert funds to impermissible activities. That separation
would thus ensure that Title X funds are used for the purposes
expressly mandated by Congress, that is, to offer family planning
methods and services--and that any infrastructure built with Title X
funds would not be used for impermissible purposes.
N. Transition Provisions (42 CFR 59.19)
Summary of changes: The proposed rule would add Sec. 59.19, which
specifies the effective dates and compliance dates of the provisions of
the proposed rule. The Department finalizes this provision with changes
to the compliance dates in response to public comments, and makes some
minor formatting and technical edits to improve readability.
Comments: Many commenters contend transition periods by which
covered entities must comply with the rule are not long enough. Some
recommend lengthening the physical separation transition period from
one to two years, while many recommend extending the period to three
years. Some contend they do not know how long would be needed for
compliance, but at least an additional year is needed. Various
commenters worry that many Title X recipients would be unable to
receive care while clinics are in the process of separating after the
proposed one year time period expires.
One commenter asks that the changes be scheduled to take effect at
the end of the project period during which the rule is finalized in
order to limit confusion for current grantees. One commenter suggests
that Title X create different transition requirements for different
Title X providers based on resource-level, location revenue, and client
population.
Additionally, one commenter notes the cost of establishing new
Electronic Health Record (EHR) systems would include the costs for new
hardware and infrastructure for these systems. In New York State,
providers may not purchase equipment in the final year of a grant
cycle. Since 2019 is the final year of the grant for New York State
Family Planning projects, the commenter contends that these providers
would be unable to comply with the new requirements until a new grant
is issued.
One commenter requests that the financial transition period be
lengthened from 60 days to six months, stating that, according to
businesses that provide modification and implementation of EHR systems,
six months, at minimum, is needed. The majority of commenters
recommended changing the transition period to one year for financial
separation.
Response: The effective date for all sections of the final rule is
60 days after publication of this rule in the Federal Register, as set
forth in the Dates section of this notice. Except with respect to the
provisions for which the Department establishes a separate compliance
date, covered entities will be expected to comply with the requirements
of this final rule by that date.
The Department extends some of the compliance dates of certain
sections or paragraphs in the rule, by which covered entities must
comply with those sections after their effective date, in response to
public comments as follows.
The Department maintains the compliance date of one year for the
physical separation requirements of Sec. 59.15. The Department
disagrees with commenters who contend one year is an insufficient time
period for covered entities to comply with the physical separation
requirement of the rule. The Department believes one year is an ample
and generous amount of time for an entity to rearrange locations, find
new locations, comply with related State requirements, or even make
changes to a facility to physically separate Title X services from
abortion services. These rules might be satisfied by placing Title X
projects (or the abortion services) in a different location without
changing any physical or facility space. It is not uncommon for health
care providers to change locations, change their physical space, or
even add new service delivery locations. As a result, the Department
disagrees with commenters who assert that patients will lose service
because of the physical separation requirement would apply beginning
one year after the publication of the final rule.
The Department agrees with commenters who contend some other
components of Sec. 59.15, such as those pertaining to electronic
health records, should also be subject to the one-year separation
requirement. The Department considers the electronic health records to
pertain to physical separation and, thus, subject to the one-year
compliance deadline. However, the Department will require that Title X
projects and providers comply with the requirement of financial
separation by July 2, 2019. The Department therefore finalizes
paragraph (a) of the transition rule specifying the compliance date for
the physical separation requirements contained in Sec. 59.15, by which
covered entities must comply with such requirement, as March 4, 2020.
Title X projects may comply with the physical
[[Page 7775]]
separation requirements of Sec. 59.15 earlier than the one year
compliance date if they choose, and may comply with the financial
separation requirements of Sec. 59.15 earlier than the 120 day
compliance date if they choose. Prior to the compliance date for the
financial separation requirements of this final rule, the Department
expects that grantees will comply with the ``Separation'' section of
the guidance at 65 FR 41281, 41282, or with the financial separation
requirements of Sec. 59.15.
Various parts of the final rule impact applications for grants,
namely Sec. 59.7, the removal of Sec. 59.5(a)(10)(i), and Sec.
59.5(a)(13) as it applies to grant applications. The Department intends
that these requirements will apply prospectively to applications for
competitive or continuation awards, but not to applications that have
been submitted before publication of the final rule or that are due in
a time period soon after publication of the final rule. The Department
intends that these provisions will apply to applications for which the
Department has informed the applicant these provisions will apply.
Therefore, the Department finalizes paragraph (b) of the transition
section to establish that the compliance date for covered entities
regarding Sec. 59.7, the deletion of Sec. 59.5(a)(10)(i), and Sec.
59.5(a)(13) as it applies to grant applicationswill be the date on
which competitive or continuation award applications are due, where
that date occurs after July 2, 2019.''
The Departments have carefully reviewed comments seeking more time
for implementation of requirements for reporting, submitting
assurances, and providing certain services. These sections include
Sec. Sec. 59.5(a)(12), 59.5(a)(13) as it applies to all required
reports, 59.5(a)(14), (b)(1) and (8), 59.13, 59.14, 59.17, and 59.18.
In response to the request by commenters that more than 60 days is
needed for compliance with such requirements, the Department has
concluded that it will finalize the transition section to allow 120
days for compliance with this section. The Department believes this
provides sufficient time for grantees and subrecipients to comply with
these requirements. Therefore, the Department finalizes paragraph (c)
of the transition section to establish the compliance date for covered
entities regarding Sec. 59.5(a)(12), Sec. 59.5(a)(13) as it applies
to all required reports, Sec. 59.5(a)(14), Sec. 59.5(b)(1), Sec.
59.5(b)(8), Sec. 59.13, Sec. 59.14, Sec. 59.17, and Sec. 59.18is
July 2, 2019.''
The Department concludes that the remaining requirements of the
final rules, that is, all requirements not specified above, can be
satisfied within 60 days of publication of the final rules in the
Federal Register, that is, by the effective date. For example, Title X
projects can comply with the prohibition on referrals for abortion as a
method of family planning within 60 days. Therefore, the Department
does not establish a separate compliance date for such provisions of
this final rule.
III. Economic/Regulatory Impact and Paperwork Burden
A. Introduction and Summary
The Department examined the impacts of the final rule as required
by Executive Order 12866 on Regulatory Planning and Review (September
30, 1993); Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011); the Regulatory Flexibility Act, 5 U.S.C. 601
(RFA); Unfunded Mandates Reform Act, 1995, Public Law 104-4, Title II,
sec. 202(a), 109 Stat. 48, 64 (1995); Executive Order 13132 on
Federalism (August 4, 1999); the Congressional Review Act, 5 U.S.C.
804(2); section 654, 5 U.S.C. 601 (note), on the Assessment of Federal
Regulation and Policies on Families; E.O. 13771 on Reducing Regulation
and Controlling Regulatory Costs (January 30, 2017); and the Paperwork
Reduction Act of 1995, 44 U.S.C. 3501-3520.
In addition, the Department carefully reviewed the public comments,
and as a result, has updated the estimated costs for implementing the
final rule in some cases. Those changes are described below and
reflected in the narrative and calculations represented later in this
section.
1. Executive Orders 12866 and 13563 and the Congressional Review Act
Comments: Commenters contend that the Administration failed to
solicit public input on the proposed rule, citing E.O. 12866, noting
that the proposed rule was not included in the Spring 2018 Unified
Regulatory Agenda and that public input was not permitted prior to
final review.
Commenters contend that the proposed rule qualifies as a
``significant regulatory action'' under E.O. 12866 and E.O. 13563, and
maintain that the Economic Impact Analysis performed by the Department
failed to address the potential cost to patients and providers.
Commenters contend that the Department focused on the benefits and
protections of the proposed rule, but failed to adequately address
potential problems. For example, commenters contend that the Department
did not accurately estimate costs associated with the physical
separation requirement, the new definition of ``low income family,''
and unintended births that will result from the regulation.
Response: Although some commenters claimed that this rule would
increase unintended pregnancies, the Department disagrees, for the
reasons set forth above, and believes this rule will lead to a better
or wider distribution of family planning services. In any event, the
Department is not aware, either from its own sources or from
commenters, of actual data that could demonstrate a causal connection
between the type of changes to Title X regulations contemplated in this
rulemaking and an increase in unintended pregnancies, births, or costs
associated with either, much less data that could reliably calculate
the magnitude of that hypothetical impact. Therefore, the Department
concludes that those are not likely or calculable impacts for the
purpose of the Executive Order.
The Department's impact analysis provides its best thinking on the
effects of the proposed rule. It acknowledges that it is difficult to
forecast all of its effects, and acknowledges uncertainty regarding the
estimates. However, the Department believes that this proposed rule
will result in better outcomes for people interested in utilizing Title
X family planning services and does not believe that public comments
provided substantive evidence of negative effects of the proposed rule.
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Under
Executive Order 12866, the Office of Management and Budget's (OMB's)
Office of Information and Regulatory Affairs determines whether a
regulatory action is significant and, therefore, subject to the
requirements of the Executive Order and review by OMB. Section 3(f) of
Executive Order 12866 defines a ``significant regulatory action'' as an
action that is likely to result in a rule that (1) has an annual effect
on the economy of $100 million or more, or adversely affects in a
material way a sector of the economy, productivity, competition, jobs,
the environment, public health or safety, or State, local or tribal
governments or communities (also referred to as economically
significant); (2) creates serious inconsistency or otherwise interferes
with an action taken or
[[Page 7776]]
planned by another agency; (3) materially alters the budgetary impacts
of entitlement grants, user fees, or loan programs, or the rights and
obligations of recipients thereof; or (4) raises novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order. OMB has determined
that this final rule is a significant, but not economically
significant, regulatory action under section 3(f) of Executive Order
12866.
2. Regulatory Flexibility Act (RFA)
The RFA requires agencies that issue regulations to analyze options
for regulatory relief of small entities, businesses, 501(c)(3)
entities, as well as government entities if a rule has a significant
impact on a substantial number of small entities. The RFA generally
defines a ``small entity'' as (1) a proprietary firm meeting the size
standards of the Small Business Administration (SBA); (2) a nonprofit
organization that is not dominant in its field; or (3) a small
government jurisdiction with a population of less than 50,000. (States
and individuals are not included in the definition of ``small
entity.'') The Department considers a rule to have a significant
economic impact on a substantial number of small entities if at least
5% of small entities experience an impact of more than 3% of revenue.
The Department does not believe that the rule will have a significant
economic impact on a substantial number of small entities. Supporting
analysis is provided below.
3. Unfunded Mandates Reform Act
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any 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 one year.'' Public Law 104-4, Title II, sec. 202(a),
109 Stat. 48, 64 (1995). The current threshold after adjustment for
inflation is $150 million. The Department does not expect this rule to
result in expenditures that would exceed this amount.
4. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a rule that imposes substantial
direct requirement costs on State and local governments or has
federalism implications.
Comments: Commenters contend that the Department is preempting
State law (without approval from Congress) by eliminating abortion
referral and counseling requirements for Title X projects. Commenters
assert that the Department failed to obtain State and local government
input on the proposed rule, and failed to provide a comprehensive
analysis for the Federalism implications of the proposed rule, which
would have included a summary of the concerns expressed by State and
local government officials. Commenters note that the Department
included a federalism impact statement in a 2016 effort to revise Title
X eligibility funding and argued that one should be required for this
rule as well. Commenters recommend that an analysis be conducted that
will assess how to address potential conflicts between the rule and
State law. Commenters assert that State and local entities qualify as
Title X grantees or subrecipients and would incur increased costs
associated with providing access to services no longer provided by
Title X, as well as costs associated with reduced access to those
services for the public.
One commenter stated that the Department did not adequately assess
the impact of the NPRM on individuals' health and well-being, as is
required under Public Law 105-277. According to the commenter, the
Department provided no details of an assessment in the NPRM, but only
stated that the proposed rule would not negatively impact health and
well-being. The commenter requests that the Office of Management and
Budget (OMB) look into this issue.
Response: The Department disagrees with commenters who suggest the
proposed rule preempts State law by removing the requirement for
abortion counseling and referral. This regulation only impacts the
Title X program and has no impact on State laws that may, in other
venues or circumstances, require State or local entities to counsel
and/or refer for abortion. And to the extent that any State laws
requiring referral for abortion cannot be carried out in a Title X
project, it is due to Congress's restriction on the use of Title X
funds in projects where abortion is a method of family planning.
The Department also disagrees with comments suggesting that
federalism requires the Department to permit Title X projects to
provide directive counseling and information about abortion, or
referrals for abortion. As the Supreme Court held in Rust v. Sullivan,
the federal government is not required to fund Title X projects that
promote or refer for abortion. 500 U.S. at 193-94. Regardless of the
status of State laws that some commenters say require the provision of
directive counseling, information, or referrals for abortion, neither
the principle of federalism nor the Constitution requires the federal
government to fund Title X programs or projects--or any other program--
that include directive counseling, information, or referrals for
abortion as a method of family planning. And the Department believes it
would be inconsistent with restrictions on the Title X program to allow
(or require) Title X projects to provide directive counseling about
abortion. The Department has determined that the final rule will not
contain policies that have substantial direct effects on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. The changes in the rule represent the Federal Government
regulating its own program.
The Department disagrees with comments that suggest the inclusion
of a federalism impact statement in the 2016 Title X regulation demands
the same for this rule. The 2016 regulation was a regulatory change to
the status quo of the 2000 regulations that limited the ability of
states and other grantees to choose their own subrecipients; the
Department specifically stated that its reason for issuing the rule was
to respond to new approaches to competing or distributing Title X funds
that were being employed by several States. As a result, the 2016
regulation had a federalism impact. This final rule, however, removes a
provision that Congress has already legislatively repealed through the
Congressional Review Act. That regulatory provision was nullified as a
matter of law when the President signed the repeal. This rule simply
conforms the text of the Title X regulations to what Congress has
already done. Consequently, there is no federalism impact of the
removal of this provision.
Additionally, States are free to apply or not apply for Title X
funding and so are only required to comply with regulations in this
Federal program if they decide to apply for a grant under the
discretionary Title X program and, thereby, voluntarily agree to follow
the statutory program integrity provisions, the regulation provisions,
and those requirements communicated in the funding announcement. Should
they agree that the Title X program is a good fit for their State
government
[[Page 7777]]
application, this regulation establishes the program's core
requirements to maintain statutory program integrity, but States (or
other grantees) have the freedom to implement their own programs,
select their own subrecipients, establish their own referral networks,
and test approaches within this framework to identify the most
effective and innovative means to serve Title X patients in their
States.
The Department disagrees with comments suggesting that State and
local entities will incur additional costs to provide services that
were once part of Title X, but are no longer permitted. Commenters fail
to provide convincing evidence of these costs and also fail to provide
evidence that there will be reduced access to Title X services as a
result of this rule. Accordingly, the Department concludes that the
final rule does not contain policies that have federalism implications,
as defined in Executive Order 13132 and, consequently, a federalism
summary impact statement is not required.
5. Summary of the Final Rule
This final rule amends the regulations governing the Title X
program to ensure programmatic compliance with statutory program
integrity provisions. Specifically, the rule:
(1) Aligns the regulation with the statutory requirements and
purpose of the Title X program, the appropriations provisos and riders
addressing the Title X program, and other obligations and requirements
established under other Federal law;
(2) Expands the scope of enforcement and auditing mechanisms
available to the Department to enforce such program requirements; and
(3) Requires individuals and entities covered by this proposed rule
to adhere to certain procedural and administrative requirements that
aim to improve client care and increase transparency.
The Department evaluated the effects of this rule over 2019-2023.
As a result of comments, it has increased estimated costs. Costs are
estimated to be $69.2 million in 2019 and $14.8 million in subsequent
years. Present value costs of $110.4 million and annualized costs of
$26.4 million are estimated using a 3% discount rate; present value
costs of $91.1 million and annualized costs of $27.2 million are
estimated using a 7% discount rate. The quantified and non-quantified
benefits and costs are summarized in Table 1.
Table 1--Accounting Table of Benefits and Costs of All Proposed Changes
----------------------------------------------------------------------------------------------------------------
Present value over 5 years by Annualized value over 5 years
discount rate (Millions of by discount rate (Millions of
2016 dollars) 2016 dollars)
---------------------------------------------------------------
3 Percent 7 Percent 3 Percent 7 Percent
----------------------------------------------------------------------------------------------------------------
Benefits:
Quantified Benefits......................... 0 0 0 0
----------------------------------------------------------------------------------------------------------------
Non-quantified Benefits (see below):
Program integrity of Title X, especially with respect to ensuring that projects and providers do not fund,
support, or promote abortion as a method of family planning. Enhanced compliance with statutory
requirements and appropriations riders and provisos. Expanded number of entities interested in
participating in Title X, including by the removal of abortion counseling and referral requirements that
potentially violate federal health care conscience protections. Enhanced patient service and care..........
----------------------------------------------------------------------------------------------------------------
Costs:
Quantified Costs............................ 110.4 91.1 26.4 27.2
----------------------------------------------------------------------------------------------------------------
Non-quantified Costs:
None........................................................................................................
----------------------------------------------------------------------------------------------------------------
B. Analysis of Economic Impacts
1. Need for Regulatory Action
This final rule addresses two categories of problems:
(1) Insufficient compliance with the statutory program integrity
provisions and the purpose and goals of the Title X program (especially
those related to section 1008), the appropriations provisos and riders
addressing the Title X program, and other obligations and requirements
established under other Federal law; and
(2) Lack of transparency regarding the provision of services (with
respect to both the identity of the providers and the services being
provided by such entities). Each of the issues fall into one or more of
these categories.
While the 2000 regulations state that Title X projects must not
provide abortion as a method of family planning, they do not provide
sufficient guidance to ensure that Title X projects comply with section
1008 by not encouraging or promoting abortion as a method of family
planning. Limiting section 1008's prohibition to only ``direct''
facilitation of abortion is not consistent with the best reading of
that provision, which was intended to ensure that Title X funds are
also not used to encourage or promote abortion. For example, the 2000
regulations:
Mandate that providers provide counseling on and referral
for abortion, if requested by the client;
Permit shared locations, facilities, personnel, file
systems, phone numbers, and websites between Title X clinics and
abortion clinics, creating confusion regarding the scope of Title X
services and whether the Federal government is funding abortion
services; and
Permit a fungibility of assets that can be used to free
funds and build infrastructure for abortion services, including
physical space, health information technology systems, community
recruitment, and bulk purchase of contraceptives and other clinic
supplies.
The lack of clear operational guidance on the abortion restriction
in section 1008 has created confusion as to what activities are
proscribed by section 1008. With abortions increasingly performed at
nonspecialized clinics primarily serving contraceptive and family
planning clients, it is critical that the Department ensure that
Federal funds are not directly or indirectly supporting, encouraging,
or promoting abortion as a method of family planning and that there is
a clear demarcation between Title X services and abortion-related
services for which Title X funds cannot be used.
The 2000 regulations suffer from additional deficiencies. They are
inconsistent with the conscience
[[Page 7778]]
protections embodied in the Church, Coats-Snowe, and Weldon Amendments;
do not address the statutory requirement that Title X projects
encourage family participation in minors' decisions to seek family
planning services; do not address the statutory requirement that Title
X projects provide counseling to minors on how to resist attempts to
coerce minors into engaging in sexual activities; do not expressly
address the obligation of Title X grantees and subrecipients to comply
with State sexual abuse reporting or notification requirements; and do
not expressly prohibit the use of Title X funds to encourage, promote,
or advocate for abortion, to support any legislative proposal that
encourages abortion, or to support or oppose any candidate for public
office. In addition, the 2000 regulations do not communicate that Title
X providers should either offer comprehensive primary health services
onsite or have a robust referral linkage with primary health providers
who are in close physical proximity to the Title X site. And the 2000
regulations fail to require grantees to provide the Department
sufficient information about the subrecipients with which they (or
their subrecipients) contract or other partners to whom Title X funds
may flow, thus hindering OPA from exercising appropriate oversight of
the activities of its program and project subrecipients.
This final rule addresses each of the foregoing problems. First, to
assist the Department in ensuring compliance with, and enforcement of,
the section 1008 prohibition, the final rule will prohibit family
planning projects from using Title X funds to encourage, promote,
provide, refer for, or advocate for abortion as a method of family
planning; require assurances of compliance; eliminate the requirement
that Title X projects provide abortion counseling and referral; require
physical and financial separation of Title X activities from those
which are prohibited under section 1008; and provide clarification on
the appropriate use of funds in regard to the building of
infrastructure.
To assist the Department in ensuring compliance with, and
enforcement of, appropriations provisos and riders addressing the Title
X program, the final rule also reiterates the voluntary, non-coercive
nature of Title X services; requires Title X facilities to encourage
family participation in a minor's decision to seek family planning
services; requires Title X facilities to provide minors with counseling
on how to resist attempts to coerce them into engaging in sexual
activities; prohibits the use of Title X funds for any activity that in
any way tends to promote public support or opposition to any
legislative proposal or candidate for office; clarifies the duty of
projects to comply with State and local laws requiring notification and
reporting of criminal sexual exploitation; explains that
confidentiality of information may not be used as a rationale for
noncompliance with such notification or reporting laws; and requires
assurances of compliance and maintenance of records.
To assist the Department in ensuring compliance with conscience
protections embodied in the Church, Coats-Snowe, and Weldon Amendments,
the final rule eliminates the requirement that Title X projects provide
abortion counseling and referral. These changes will also add clarity
to extant conscience protections, making it easier for entities to
participate who may have felt unable to do so in the past. In addition,
though already permitted in the 2000 regulations, the final rule
clarifies that participating entities within a project may offer only a
single method or a limited number of methods as components of a Title X
family planning project, so long as the overall project provides a
broad range of acceptable and effective family planning methods and
services throughout the service area.
Second, to ensure that the Title X program places an adequate
emphasis on holistic family planning services that recognize the need
for linkages with comprehensive primary health care providers, the
final rule clarifies the definition of family planning; provides for
the referral of pregnant patients for appropriate prenatal services;
encourages the provision of comprehensive primary health services
onsite or through a robust referral linkage; and updates the
application review criteria, including to expand provision of family
planning service in under- and un-served areas and populations.
Third, to ensure transparency regarding the provision of services,
the final rule requires additional information from applicants and
grantees regarding subrecipients, requires a clear explanation of how
grantees ensure adequate oversight and accountability for compliance
and quality outcomes among subrecipients and requires each project
supported under Title X to fully account for, and justify, charges
against the Title X grant. The Department believes these changes will
ensure that OPA has the information necessary to determine whether
Title X projects, grantees, and subrecipients are complying with the
statutory provisions of the program. Title X grantees and subrecipients
must comply with the Federal laws that are the subject of this proposed
rulemaking. In addition to conducting outreach and providing technical
assistance, OPA has the authority to initiate compliance reviews and
take appropriate action to assure compliance with the provisions in
this final rule.
2. Affected Entities
This rule would affect the operations of entities which receive
Title X grants or are subrecipients of such entities at some point in
time. According to the 2016 Family Planning Annual Report (FPAR), there
were 91 Title X grantees and 1,117 Title X subrecipients in 2016.\130\
These entities operated at 3,898 service sites, and provided services
to 4,007,552 people.\131\ For purposes of this analysis, the Department
assumes that these numbers will remain the same across time. Title X
services were delivered by 3,550 clinical services provider full-time
equivalent employees (FTEs), which include 780 physician FTEs, 258
registered nurse FTEs, and 2,512 combined FTEs from physician's
assistants (PAs), nurse practitioners (NPs), and certified nurse
midwives (CNMs).\132\ These FTEs are associated with 1,403 Title X
family planning encounters per FTE, for 5.0 million total Title X
family planning encounters across these providers in 2016.\133\ Title X
services are also delivered by other types of service providers, who
were involved with 1.7 million Title X family planning encounters in
2016.\134\ Providers in these categories include registered nurses,
public health nurses, licensed vocational or licensed practical nurses,
certified nurse assistants, health educators, social workers, and
clinic aides. The Department assumes that there are 1,403 encounters
per FTE for individuals in these categories, which implies
approximately 1,219 FTEs in this category in 2016.\135\ To convert FTEs
reported in the FPAR to the number of individuals in these categories,
the Department assumes that each individual works an average of between
0.5 FTEs and 1.0 FTEs delivering Title X services, with 0.75 FTEs as
its central estimate, uniformly
[[Page 7779]]
across occupation categories. This implies that there are approximately
4,733 clinical service providers and 1,625 other service providers
associated with the provision of Title X family planning services. The
Department will use these estimates as its estimate of service
providers affected by this rule.
---------------------------------------------------------------------------
\130\ Fowler et al., Family Planning Annual Report: 2016
National Summary 7 (Aug. 2017), https://www.hhs.gov/opa/sites/default/files/title-x-fpar-2016-national.pdf.
\131\ Id. at 8.
\132\ Id. at 49-51.
\133\ Id. at 51.
\134\ Id. at 24.
\135\ Id. at 49.
---------------------------------------------------------------------------
The Department estimates the hourly wages of individuals affected
by this proposed rule using information on hourly wages in the May 2016
National Occupational Employment and Wage Estimates provided by the
U.S. Bureau of Labor Statistics \136\ and salaries from the U.S. Office
of Personal Management.\137\ It uses the salary of registered nurses as
a proxy for ``other clinical service providers'' and ``other types of
service providers'' described above. In FPAR, PAs, NPs, and CNMs are
not distinguished. Since wages in these three categories are very
similar, the Department uses the average wage across this group when
discussing impacts affecting the group. The Department uses the wages
of Medical and Health Services Managers as a proxy for management
staff, and the wages of Lawyers as a proxy for legal staff throughout
this analysis. To value the time of potential Title X service grantees,
the Department takes the average wage across all occupations in the
U.S. The Department assumes that federal employees affected by the
proposed changes to the Title X regulation are Step 5 within their GS-
level and earn locality pay for the District of Columbia, Baltimore,
and Northern Virginia. It divides annual salaries by 2,087 hours to
derive hourly wages. It assumes that the total dollar value of labor,
which includes wages, benefits, and overhead, is equal to 200% of the
wage rate. Estimated hourly rates for all relevant categories are
included below.
---------------------------------------------------------------------------
\136\ Bureau of Labor Statistics, Occupational Employment and
Wage Statistics, (May 2016), https://www.bls.gov/oes/2016/may/oesnat.htm.
\137\ Office of Personnel Management, Salary Table 2016-DCB,
(Jan. 2016), https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2016/DCB.pdf.
---------------------------------------------------------------------------
Throughout, estimates are presented in 2016 dollars. When present
value and annualized values are presented, they are discounted relative
to year 2016. Finally, the Department estimates impact over five years
starting in 2019. Please note that the list includes staff that the
Department assumes will be impacted by the final rule and is inclusive
of those positions which are included in the APP category.
Table 2--Hourly Wages
------------------------------------------------------------------------
------------------------------------------------------------------------
Physician............................................... $101.04
Physician Assistant..................................... 49.08
Nurse Practitioner...................................... 50.30
Certified Nurse Midwife................................. 49.23
Registered Nurse........................................ 34.70
Medical and Health Services Managers.................... 52.58
Lawyers................................................. 67.25
Federal employees in the District of Columbia,
Baltimore, and Northern Virginia (2016)
GS-13 Step 5.......................................... 50.04
GS-14 Step 5.......................................... 59.13
GS-15 Step 5.......................................... 69.56
------------------------------------------------------------------------
3. Estimated Costs
a. Learning the Rule's Requirements
To comply with the regulatory changes proposed in this final rule,
affected entities must learn the rule's requirements, review their
policies in the context of these new requirements, and determine how to
respond. Affected entities here would include not only existing
grantees and subrecipients, but also potential grantees and
subrecipients. Consistent with our view that this proposed rule would
increase competition for Title X funding, the Department estimates that
potential grantees and subrecipients range from between 100% and 300%
of their 2016 values, with a central estimate of 200%. This implies 182
potential grantees and 2,234 potential subrecipients. The Department
estimates that learning the final rule's requirements and determining
how to respond would require an average of 20 hours for potential
grantees and an average of 10 hours for potential subrecipients,
divided evenly between managers and lawyers, in the first year
following publication of the final rule. As a result, using wage
information provided in Table 2, this implies costs of $3.11 million in
the first year following publication of the final rule.
b. Training
Individuals involved with delivering family planning services would
need to receive training on the requirements of the final rule. To
convert FTEs reported in FPAR to the number of individuals who would
receive training, the Department assumes that each individual works an
average of between 0.5 FTEs and 1.0 FTEs delivering Title X services,
with 0.75 FTEs as its central estimate. This implies that there are
approximately 4,733 clinical service providers and 1,625 other service
providers who will need training in order to ensure compliance with
these regulations. The Department estimates that these individuals
would require an average of 4 hours of training in the first year
following publication of this rule. In subsequent years, it assumes
that this new information would be incorporated into existing training
requirements, resulting in no incremental burden. As a result, using
wage information provided in Table 2, this would imply costs of $2.71
million in the first year following publication of a final rule in this
rulemaking.
In addition, training materials would need to be updated to reflect
changes made by this rulemaking. Training materials for Title X
providers are currently developed by contract. The Department estimates
that these updates would cost approximately $200,000. In addition,
changes to training materials would require interaction with OPA
employees in order to ensure that the materials are suitable for Title
X providers. The Department estimates that this would require half of
an FTE at the GS-13 level and half of an FTE at the GS-14 level. It
estimates that all of these costs would be incurred in the first year
following publication of the final rule. Using wage information
provided in Table 2, this would imply costs of $0.43 million in the
first year after publication of the final rule.
c. Assurance Submissions
Title X grantees and subrecipients face new assurance requirements
because of this final rule. The Department estimates that these new
requirements would require a lawyer to spend an average of 3 hours
reviewing the assurances and 3 hours reviewing organizational policies
and procedures or taking other actions to assess compliance, and a
medical and health services manager to spend 2 hours total for the same
tasks the first year of the final rule for each grantee and
subrecipient. In subsequent years, the Department estimates that these
new requirements would require a lawyer to spend an average of 1 hour
reviewing the assurances, 3 hours reviewing organizational policies and
procedures or taking other actions to assess compliance, and a medical
and health services manager to spend 2 hours total for the same tasks
at each grantee and subrecipient. Using wage information provided in
Table 2, this would imply costs of $1.2 million in the first year
following publication of the final rule, and $0.9 million in subsequent
years.
d. Documentation of Compliance
Title X grantees and subrecipients need to document their
compliance
[[Page 7780]]
with new requirements because of this final rule. First, Title X
grantees are required to encourage minors to involve family in their
decisions to seek family planning services. Actions taken to satisfy
this requirement must be documented in a minor's medical record. The
Department estimates that each occurrence would require a physician
assistant to spend an average of 2 minutes to make appropriate
documentation in a minor's medical records. Approximately 20% (800,000)
of the 4 million Title X clients are adolescents. The Department
estimates that complying with the requirement to encourage family
participation will result in 75% (600,000) of adolescent patients'
medical records requiring appropriate documentation. Using wage
information provided in Table 2, this would imply costs of $2.0 million
in each year following publication of this rule.
In addition, the rule requires Title X projects to report certain
crimes in compliance with State notification laws, and to counsel
minors on how to resist sexual coercion, but the Department does not
include cost estimates for compliance with these provisions because
grantees are already required to comply with these congressional
mandates. However, while Congress encourages family participation,
especially related to minors, this rule requires an additional
compliance step that grantees document that they encourage family
participation with each minor--and to so document this conversation in
each minor's patient file.
Second, grantees must generate reports with information related to
subrecipients involved in the grantee's Title X project. The Department
believes that this will impose direct and indirect costs. It estimates
that these new requirements would require a health services manager to
spend an average of 4 hours in each year following publication of the
final rule at each grantee and subrecipient. Using wage information
provided in Table 2, this would imply costs of $0.5 million in each
year following publication of a final rule in this rulemaking.
In addition, based on public comment, the Department also believes
that these documentation requirements will result in indirect costs. In
particular, it believes that affected entities may update systems to
facilitate newly required documentation and reporting. It estimates
that between 25% and 75% of service sites, with a central estimate of
50%, will make changes along these lines in response to these new
requirements. These changes could range from very minor tweaks to
existing systems to more comprehensive overhauls. The Department
estimates that an average of between $1,000 and $5,000, with a central
estimate of $3,000, would be incurred at these sites in the first year
following publication of this proposed rule. This would imply costs of
$11.69 million in the first year following publication of a final rule.
e. Monitoring and Enforcement
This final rule will result in additional monitoring of Title X
grantees and subrecipients in order to ensure compliance with new
regulatory and existing statutory requirements.
Some commenters contend that requiring grantees to provide
information concerning their subrecipients will be burdensome because
of limited funding and the magnitude of oversight required and will
prohibit them from freely selecting subrecipients. Commenters contend
that these requirements will be prohibitive to providing comprehensive
care and continuing partnerships with referral agencies. Other
commenters contend that many clinics will be forced to close as a
result of the burdensome requirements and that this is evidence of a
departmental agenda to discourage participation in the Title X program.
Commenters request a response as to whether the Department has studied
the costs to subrecipients and referral agencies associated with data
collection, training and oversight. Commenters also note that other
programs with comparable federal funding are not required to submit to
the same requirements.
HHS does not agree with commenters who say that providing the
Department with information regarding subrecipients is unduly
burdensome or prohibitive, since grantees already are responsible for
ensuring that all partners who receive funding as a part of the grant
project are providing services that are responsive and compliant with
the purposes of Title X. The Department is only requiring that
compliance and appropriate service provision be documented and
submitted to HHS. Grantees may relieve reporting burdens by requiring
subrecipients to draft compliance reports that grantees can submit to
HHS after certifying their accuracy. Commenters provided no
documentation to support the assertion that such certification of
subrecipient compliance would be unique among federal programs. In
addition, as a result of comments, HHS is only requiring monitoring and
oversight of subrecipients, not referral agencies, because only
grantees and subrecipients receive Title X funds for their services.
Requirements regarding referral agencies will be limited to the grantee
providing information that they should already have available, such as
the name of the referral agency, the services it provides, and the
extent of the referral partnership. For all of these reasons, the
Department does not find this objection compelling.
Similarly, the Department does not agree with the concern expressed
by some commenters regarding the effect of this rule on quality and
accessibility of Title X services. These commenters did not provide
evidence that the rule will negatively impact the quality or
accessibility of Title X services. And the Department believes that
this rule will likely improve quality and accessibility for Title X
services.
For example, the Department expects that honoring statutory
protections of conscience in Title X may increase the number of
providers in the program. If health care providers or entities know
they will be protected from discrimination on the basis of conscience
with respect to counseling on, or referring for, abortion, they might
seek to participate in programs as a subrecipient where they may
previously have been deterred from doing so under the current
regulations because of concerns that they would be forced to violate
their religious belief or moral conviction. This may also lead to an
increase in the number of health care providers who apply and receive
funding under the Title X program, thus decreasing current gaps in
family planning services in certain areas of the country. For example,
under the 2000 regulations, some individuals and entities may have
chosen not to apply to provide Title X services because they
anticipated they would be pressured to counsel or refer for abortions.
One public commenter supporting finalization of the proposed rule on
behalf of religiously affiliated health care organizations cited
polling data and organizational comments suggesting that protecting
conscience in the Title X program would prevent medical providers or
students from refraining from participation in the program due to
concerns about being forced to violate their consciences.\138\
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\138\ See comment of Jonathan Imbody (posted July 23, 2018),
available at https://www.regulations.gov/document?D=HHS-OS-2018-0008-69125 (citing a Christian Medical Association and Freedom2Care
poll conducted on May 3, 2011, which found that 91 percent of
physicians who practiced medicine based on the principles of their
faith said they would be forced to leave medicine if coerced into
violating the faith tenets and medical ethics principles that guide
their practice of medicine). Freedom2Care and The Christian Medical
Association, National Poll Shows Majority Support Healthcare
Conscience Rights, Conscience Law (May 3, 2011), https://docs.wixstatic.com/ugd/809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf.
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[[Page 7781]]
Similarly, a certain proportion of decisions by currently
practicing health providers to leave the profession are presumably
motivated by such pressure.\139\ With the final rule's added emphasis
on protecting rights of conscience, more individuals may enter the
Title X family planning program, helping to meet that unmet need for
care.
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\139\ The Christian Medical Association and Freedom2Care poll of
May 3, 2011, found that 82% of medical professionals ``said it was
either `very' or `somewhat' likely that they personally would limit
the scope of their practice of medicine if conscience rules were not
in place. This was true of 81% of medical professionals who practice
in rural areas and 86% who work full-time serving poor and
medically-underserved populations . . . 91% agreed, `I would rather
stop practicing medicine altogether than be forced to violate my
conscience.' '') Freedom2Care and The Christian Medical Association,
National Poll Shows Majority Support Healthcare Conscience Rights,
Conscience Law (May 3, 2011).
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This effect may also occur at the macro scale in the health
industry. For example, hospitals or other facilities that will not
refer for abortion as a method of family planning may view the final
rule as granting Title X participants greater freedom to provide family
planning services consistent with their beliefs and may find it
worthwhile to apply for Title X funds, or seek to participate in a
Title X project as a subrecipient, in order to serve more people or new
populations, or underserved communities, including urban or rural,
consistent with their calling to serve the health care needs of the
poor and underserved.
As a result, the rule will not impede access to care in areas with
fewer providers, such as rural communities, but enhance it. Indeed,
because patients may seek out health care providers that reflect their
own religious beliefs or moral convictions, service delivery should be
improved because opportunities for conflict may be limited and the
cultural competency of providers may be increased.\140\ Another way
this effect may manifest itself is that, if the number of family
planning providers were to remain constant, the average provider would
have more highly qualified staff, because the Title X grantees and
their subrecipients would be selecting from a larger pool of medical
and health professionals. Ultimately, the Department believes that this
final rule will result in more Title X applicants, which will likely
translate into more diverse grantees and subrecipients. In addition,
the Department closely monitors the performance of the Title X program,
including through the Family Planning Annual Report, which should allow
the Department to quickly identify and respond to any problems in order
to maintain high quality standards within the program.
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\140\ In a 2011 poll, 88% of adults said it was very or somewhat
important that they share moral beliefs with their health care
providers. See Freedom2Care and The Christian Medical Association,
National Poll Shows Majority Support Healthcare Conscience Rights,
Conscience Law (May 3, 2011).
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The Department estimates that addressing additional monitoring and
enforcement activities would require management staff for each grantee
to spend an average of an additional 40 hours each year, and would
require an average of an additional 10 hours for each Title X service
provider each year. Finally, additional monitoring and enforcement
require additional time by Federal staff. The Department estimates this
would require 3 FTEs at the GS-13 level, 2 FTEs at the GS-14 level, and
2 FTEs at the GS-15 level. As a result, using wage information provided
in Table 2, this would imply costs of $8.53 million every year
following publication of this rule.
f. Physical Separation
As a result of this final rule, Title X providers would be required
to provide Title X services at facilities that are physically separate
from facilities at which abortion as a method of family planning is
provided. A Congressional Research Service \141\ report estimates that
10% of clinics that receive Title X funding offer abortion as a method
of family planning in addition to their Title X-funded activities. In
addition, Title X providers may share resources with unaffiliated
entities that offer abortion as a method of family planning. As a
result, the Department estimates that between 10% and 30% of service
sites, with a central estimate of 20%, would need to be evaluated to
determine whether they comply with the proposed physical separation
requirements. Commenters contend that the Department underestimated the
costs related to new physical separation requirements, but themselves
did not provide sufficient data to estimate these effects across the
Title X program. Commenters also provided extremely high cost estimates
based on assumptions that they would have to build new facilities in
order to comply with the requirements for physical separation from
abortion as a method of family planning. The Department does not
anticipate that entities will necessarily engage in construction of new
facilities to comply with the new requirements, rather that entities
will usually choose the lowest cost method to come into compliance. The
Department expects that the lowest cost method will vary across covered
entities depending on their circumstances, and that covered entities
will make the decision which best suits their circumstances in light of
the new requirements, and therefore that entities will likely choose
the lowest cost method, given their circumstances. For example, Title X
providers which operate multiple physically separated facilities and
perform abortions may shift their abortion services, and potentially
other services not financed by Title X, to distinct facilities, a
change which likely entails only minor costs. Other Title X providers,
with different circumstances, will have different options and therefore
may have a more or less costly lowest cost method. Furthermore, as
stated above, the Department estimates that between 10% and 30% of
service sites, with a central estimate of 20%, would be subject to
physical separation requirements, because their Title X services and
abortion services are currently collocated. Accordingly, the Department
believes that enforcing the physical separation requirements as
interpreted through Section 1008 should have minimal effect on the
majority of current Title X providers. The Department has updated
quantitative estimates in response to these comments, while
acknowledging that there is substantial uncertainty regarding the
magnitude of these effects. The Department estimates that evaluation of
sites would require an average of an additional five hours by
management staff at each of these affected service sites in the first
year following publication of the final rule. Similarly, it estimates
that this evaluation would affect between 10% and 30% of grantees, with
a central estimate of 20%. The Department estimates that this would
require an average of an additional forty hours, divided evenly between
lawyers and management staff, for each affected grantee, in the first
year following publication of a final rule. It estimates that these
evaluations would determine that between 10% and 20% of service sites,
with a central estimate of 15%, do not comply with physical separation
requirements. At each of these service sites, the Department estimates
that an average of between $20,000 and
[[Page 7782]]
$40,000, with a central estimate of $30,000, would be incurred to come
into compliance with physical separation requirements in the first year
following publication of a final rule in this rulemaking. This estimate
is an increase from an averaged estimate between $10,000 and $30,000 in
the proposed rule. Using wage information provided in Table 2, this
would imply costs of $36.08 million in the first year following
publication of a final rule, an increase from an estimated cost of
$24.38 million in the proposed rule.
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\141\ Angela Napili, Title X (Public Health Service Act) Family
Planning Program, Congressional Research Service 22 (Aug. 31, 2017),
https://fas.org/sgp/crs/misc/RL33644.pdf.
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The Department does not anticipate that these requirements will
have a significant impact on access to services. Although some
facilities may relocate in response to the new requirement, the
Department does not anticipate that there will be a decrease in the
overall number of facilities offering services, since it anticipates
other, new entities will apply for funds, or seek to participate as
subrecipients, as a result of the final rule. Further, the Department
cannot calculate or anticipate future turnover in grantees. Various
entities may change their decision to apply to be a grantee or sub-
grantees or may change the way in which they provide services,
affecting the viability of their applications. Such calculations would
be purely speculative, and, thus, very difficult to forecast or
quantify. Based on the Department's best estimates, it anticipates that
the net impact on those seeking services from current grantees will be
zero, as any redistribution of the location of facilities will mean
that some seeking services will have shorter travel times and others
seeking services will have longer travel times to reach a facility.
Additionally, as a result of this final rule, the Department
anticipates expanded competition that will engender new and/or
additional grantees who will serve previously unserved or underserved
areas, likely expanding coverage and patient access to services.
g. Encouraging Parental Involvement in Family Planning Services
Title X providers are already required by the Title X statute to
encourage minors to involve their parents in family planning services,
but this rule would ensure that actions are taken to satisfy this
requirement and require such actions be documented in a minor's medical
record. As noted previously, the Department estimates that complying
with the requirement to document the encouragement of family
participation will result in 600,000 adolescent patients' medical
records requiring documentation each year. The Department estimates
that an additional 0-50% of these adolescents, with a central estimate
of 25%, would receive additional encouragement to involve parents each
year. It estimates that this would require an average of an additional
ten minutes spent by a registered nurse and ten minutes spent by the
service recipient in each case. These impacts would occur each year
upon publication of this final rule. Using wage information provided in
Table 2, this would imply costs of $2.93 million in each year upon
publication of this final rule.
The Department does not include costs associated with compliance
with State reporting requirements or the requirement that minors
receive counseling to avoid sexual coercion because these Congressional
requirements should already be satisfied by grantees.
4. Estimated Benefits
This final rule is expected to offer benefits to taxpayers and
stakeholders who want assurance that their tax dollars are being used
in compliance with the requirements of the Title X program. It is also
expected to increase the number of entities interested in participating
in Title X as grantees or subrecipient service providers and, thereby,
to increase patient access to family planning services focused on
optimal health outcomes for every Title X client. Third, because of the
clarifying language, as well as the new provisions within this rule,
the Department expects the quality of service to improve. Finally, the
rule would clarify the role of the Title X program within communities
across the nation, expand and diversify the field of medical
professionals who serve individuals and families, and build a better
appreciation for the important services offered as a result.
a. Upholding and Preserving the Purpose and Goals of the Title X
Program
As discussed throughout this rule, the statutory prohibition on the
use of Title X funds in programs/projects where abortion is a method of
family planning has been in existence as long as the program. This
final rule is expected to provide the Department with tools to ensure
compliance with those statutory requirements. It is also expected to
increase transparency and assurances that taxpayer dollars are being
used as Congress intended. The Title X program, too, would benefit, as
the requirement of physical and financial separation and the
prohibition on infrastructure building for non-Title X purposes will
ensure greater accountability for the use of Federal funds and mitigate
confusion about what services the Federal government supports and
funds.
b. Patient/Provider Benefits and Protections
The Department expects that the final rule will have additional
benefits for patients and providers. Benefits for patients are
significant. First, as noted above, the new regulation will encourage
Title X service providers to offer either comprehensive primary health
services onsite or have a robust referral linkage with primary health
providers who are in close physical proximity to the Title X site. This
will promote seamless care and services for patients while expanding
the breadth of services available within the States, territories, and
throughout the regions.
Second, the final rule will protect certain patients from coercion
or further victimization. It will require Title X facilities to counsel
minors on how to resist attempts to coerce them into engaging in sexual
activities. Such consulting would serve to help minors resist coercion
and exercise self-determination. In addition, the final rule will
protect certain Title X patients from further victimization by
requiring Title X grantees and subrecipients to comply with all State
and local laws requiring notification or reporting of child abuse,
child molestation, sexual abuse, rape, incest, intimate partner
violence, and human trafficking; to develop a plan for such compliance
and provide adequate training for all personnel on the subject; and to
maintain records identifying the age of any minor clients served, the
age of their sexual partner(s) where required by law, and the reports
or notifications made to appropriate State or local law enforcement or
other authorities, in accordance with such laws. These provisions would
protect patients, especially minor children, from further
victimization, and promote the identification and bringing to justice
of those who would prey on women, men, and children.
For providers, the final rule is expected to create benefits
through respect for conscience. It will do so by better aligning the
Title X regulations with the statutory prohibitions on discrimination
against health care entities, including individual health care
providers, who refuse to participate in abortion-related activity such
as counseling on, and referral for, abortion. Potential grantees and
subrecipients that refuse to provide abortion counseling and referrals
will clearly be eligible to participate in the Title X program and to
apply to provide family planning
[[Page 7783]]
services as grantees or subrecipients. And the expansion of provider
and family planning options would have salutary benefits for patients,
including for patients who seek providers who share their religious
beliefs or moral convictions.
As the Department has stated with regard to other conscience
protection actions, open communication in the doctor-patient
relationship would foster better over-all care for patients. While the
benefit of open and honest communication between a patient and her
doctor is difficult to quantify, one study showed that even ``the
quality of communication [between the physician and patient] affects
outcomes . . . [and] influences how often, and if at all, a patient
would return to that same physician.'' \142\ Facilitating open
communication between providers and their patients helps to eliminate
barriers to care. Because positions of conscience are often grounded in
religious influence, ``[d]enying the aspect of spirituality and
religion for some patients can act as a barrier. These influences can
greatly affect the well-being of people. These influences were reported
to be an essential element in the lives of certain migrant women which
enabled them to face life with a sense of equality.'' \143\ It is
important for patients seeking care to feel assured that their faith,
and the principles of conscience grounded in their faith, would be
honored, especially in the area of family planning. This would ensure
that patients with such religious beliefs or moral convictions feel
they are being treated fairly and that their religious beliefs or moral
convictions are respected.\144\
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\142\ Fallon E. Chipidza, F. E. et al., Impact of the Doctor-
Patient Relationship, The Primary Care Companion for CNS Disorders
17(5) (Oct. 22, 2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732308.
\143\ Scheppers, E. et al., Potential Barriers to the Use of
Health Services Among Ethnic Minorities: A Review, Family Practice
(23):325, 343 (June 1, 2006), https://academic.oup.com/fampra/article/23/3/325/475515.
\144\ Id.
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C. Analysis of Regulatory Alternatives
The Department considered a variety of options to ensure that it is
clear to grantees, the general public, and patients who depend upon
Title X services, that Title X programs do not fund, support, or
promote abortion as a method of family planning. Specifically, the
Department considered:
(1) Maintaining the status quo, where only line-item, pro-rated
financial separation from activities that treat abortion as a method of
family planning is required. However, such financial accounting
separation leaves too much ambiguity surrounding abortion activities
that may be a part of the overall services of the organization or
facility, although not a part of Title X-funded family planning
services. The Department considered utilizing programmatic guidance and
funding opportunity announcements (FOAs, also known as notices of
funding opportunities) to address that problem, but such actions would
not be able to fix the requirement that Title X providers provide
counseling on, and referral for, abortion upon request, a requirement
inconsistent with federal conscience laws, and at least in terms of
abortion referrals, is also inconsistent with section 1008 and that
could be discouraging to potential grantees and subrecipients that
refuse to counsel on, or provide referrals for, abortion. The
maintenance of this requirement, as noted above, is potentially
inconsistent with the Coats-Snowe Amendment and the Weldon Amendment.
Moreover, part 59 as it currently exists, affords no mechanisms by
which the Department would be able to verify whether grantees and their
subrecipients are complying with the statutory program integrity,
education, and reporting requirements. In addition, the Department
would still be required to use application review criteria that the
Department now believes fail to ensure that applicants comply with the
statutory requirements of the Title X program. As detailed earlier,
application review criteria must serve as a meaningful instrument to
assess the quality of the applicant and the application. While the
Department had discretion under the 2000 regulations to strengthen the
selection criteria through FOA requirements, such an approach does not
give the public notice of the long term commitment of the program.
(2) Requiring signage, brochures or separate staff and examination
rooms within the same physical space to delineate a separation between
Title X and abortion-related services. The Department considered that
this less restrictive option might serve the same goal as physical
separation in erasing, or mitigating, the current confusion between
Title X and abortion-related services. But the Department determined
that a shared reception area with materials available on both Title X
family planning services and abortion-related services would continue
the confusion, rather than mitigate it. Signage is often not read, and
the segregation of staff or staff responsibilities within the same
reception area likely would not provide sufficient distinction to end
confusion. If the same physical space provides both Title X and
abortion-related services, signs and separate receptionists may only
diminish, but not eliminate, the public perception and confusion.
Different examination rooms would likely have little impact because
patients would be unaware that the purpose of a suite of examination
rooms differs by funding stream, if the entrance and reception area is
shared in common. The optics and practical operation of two distinct
services within a single collocated space are difficult, if not
impossible to overcome.
Commenters contend that the Department neglected to fully address
the economic impact of proposed regulatory provisions, maintain that
there are more cost-effective alternatives, and present three
regulatory alternatives that would not substantively change the status
quo and which were not considered in the analysis: (1) Provide
exemptions to those with objections to providing information about
abortion; (2) improve public education efforts, so the public
understands Title X funds cannot be used for abortion; and (3) permit
longer time frames between finalization of, and required compliance to,
the final rule in order to lower costs associated with implementation.
The Department appreciates these suggestions, but does not accept
these as meaningful alternatives to the changes proposed by the rule.
While cost is an important consideration in any rulemaking, compliance
with statutory program integrity provisions is of greater importance
and none of the alternatives suggested by commenters guarantees such
program integrity. The first alternative, the provision of exemptions
to those who object to providing information concerning abortion, is
unnecessary with the elimination of the requirement for abortion
counseling and referral. Also, the Department's approach obviates the
need for a burdensome process, involving the expenditure of additional
time and resources by both the provider and the federal government
associated with proposing, processing, and investigating each request
for exemption. The elimination of the requirement for abortion
counseling and referral, coupled with the regulatory permission for
nondirective pregnancy counseling, achieves the same objective without
the need for such a burdensome process. In addition, the mere existence
of the requirements--even with a process to apply for exemptions--may
serve to discourage organizations with religious or moral objections to
[[Page 7784]]
counseling on, or referring for, abortion from applying. Moreover, that
alternative does not address the fact that the Department believes that
the current requirement to provide abortion referrals upon request is
inconsistent with PHS Act Sec. 1008's prohibition on funding projects
where abortion is a method of family planning. Second, the Department
agrees that educational efforts to help the general public understand
the services provided by Title X would be beneficial, but this
alternative does not negate the need for clear and understandable
separation between Title X services and abortion services at the clinic
level. Physical separation assists with statutory compliance, in
addition to improving public perception, by ensuring that both
intentional and unintentional comingling of resources, activities, and
services do not take place in ways that are exacerbated when both
services are housed in the same space. Finally, the Department
considered longer implementation periods and has updated and extended
transition periods and compliance dates for the provisions of this
final rule, in response to comments, but the Department is not
convinced that extending the time period for compliance with the final
rule in any way decreases the overall cost.
The Department, therefore, concludes that no other alternative
would adequately address the two categories of problems it seeks to
address: (1) Insufficient compliance with the statutory requirements
and the purpose and goals of the Title X program (especially those
related to section 1008), the appropriations provisos and riders
addressing the Title X program, and other obligations and requirements
established under other Federal laws; and (2) lack of transparency
regarding the provision of Title X family planning services.
Thus, for these reasons and other stated reasons for our decision
to propose both physical and financial separation, the Department
determines that all of these options would be insufficient to ensure
statutory compliance and clarity regarding such compliance.
D. Executive Order 13771
Executive Order 13771 on Reducing Regulation and Controlling
Regulatory Costs (January 30, 2017) requires that the costs associated
with significant new regulations ``to the extent permitted by law, be
offset by the elimination of existing costs associated with at least
two prior regulations.'' This final rule is considered an Executive
Order 13771 regulatory action. The Department estimates that this rule
generates $15.0 million in annualized costs at a 7% discount rate,
discounted relative to fiscal year 2016, over a perpetual time horizon.
E. Regulatory Flexibility Analysis
As discussed above, the RFA requires agencies that issue a
regulation to analyze options for regulatory relief of small entities
if a rule has a significant impact on a substantial number of small
entities. The Department considers a rule to have a significant
economic impact on a substantial number of small entities if at least
5% of small entities experience an impact of more than 3% of revenue.
In the public comments, some commenters contend that implementing
the new requirements within the first year after publication of the
final rule will require transitioning to electronic health records,
allocating staff to perform additional documentation, recruiting new
staff/consultants, engaging legal support, and allocating training time
(requiring facility closure). Commenters argue that these changes would
incur costs much higher than the Department's estimated cost to
implement the new requirements. Commenters express concern that these
requirements will result in decreased provider participation in the
Title X program, reducing services for the communities they serve.
In most cases, the Department does not find these comments
compelling, since commenters do not provide sufficient detail and
explanation. The Department accordingly does not find comments that
predicted a large impact more reliable than the estimates set forth in
the proposed rule. But the Department made some amendments to this
final rule, particularly with respect to extending compliance dates and
clarifying what requirements fall under each date of compliance. These
amendments are described in other parts of the final rule and those
germane to the RIA are detailed throughout this section.
The Department calculates the costs of the changes per service site
over 2019-2023. The estimated average annualized cost of the final rule
per service site is approximately $6,761 using a 3% discount rate,
accounting for comments received. This represents an increase from
$5,423 in the proposed rule. The Department notes that this figure
includes all costs and that relatively large entities are likely to
experience proportionally higher costs. The U.S. Small Business
Administration establishes size standards that define a small entity.
According to these standards, family planning centers with revenues
below $11.0 million are considered small entities. Since the estimated
costs of the final rule would be a small fraction of the standard by
which a family planning center entity is considered a small entity, the
Department anticipates that this final rule will not have a significant
economic impact on a substantial number of small entities.
F. Assessment of Federal Regulation and Policies on Families
Section 654 of the Treasury and General Government Appropriations
Act of 1999, Public Law 105-277, sec. 654, 112 Stat. 2681 (1998),
requires Federal departments and agencies to determine whether a policy
or regulation could affect family well-being.\145\
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\145\ This section discusses the assessment required in
Executive Order 12606, The Family, which was revoked on April 21,
1997. Office of Management and Budget, Memorandum from Jacob Lew,
Dir., To Heads of Executive Departments, Agencies, & Independent
Establishments Assessment of Federal Regulations and Policies on
Families (Jan. 26, 1999), https://www.fws.gov/policy/library/rglew.pdf.
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Agencies must assess whether the regulatory action: (1) Impacts the
stability or safety of the family, particularly in terms of marital
commitment; (2) impacts the authority of parents in the education,
nurture, and supervision of their children; (3) helps the family
perform its functions; (4) affects disposable income or poverty of
families and children; (5) if the regulatory action financially impacts
families, are justified; (6) may be carried out by State or local
government or by the family; and (7) establishes a policy concerning
the relationship between the behavior and personal responsibility of
youth and the norms of society.\146\ If the determination is
affirmative, then the Department or agency must prepare an impact
assessment to address criteria specified in the law.
---------------------------------------------------------------------------
\146\ Treasury and General Government Appropriations Act, 1999,
Public Law 105-277, sec. 654, 112 Stat. 2681, 2681-528 to 2681-530
(1998).
---------------------------------------------------------------------------
Some commenters contend that the proposed rule fails to address the
impact of unplanned births on families, arguing that unplanned births
are a known factor in familial instability and dysfunction, decreased
disposable income, and decreased relationship satisfaction. Commenters
contend that the Department has incorrectly concluded that the proposed
rule will not pose negative effects to family well-being, and noted a
lack of evidence and/or justification for this conclusion. Commenters
contend that increased
[[Page 7785]]
unintended pregnancies decrease Quality Adjusted Life Years (QALYs),
and therefore the proposed rule would result in increased costs.
Commenters contend that access to contraceptives has several benefits
including the pursuit of higher education and increased earning power
for unmarried women, leading to more enduring relationships in the
future; and enabling couples to plan the number of children in their
family, increasing parents' ability to invest in their children, and in
turn improving children's development and ability to succeed in school.
The Department does not change from its opinion that the action
taken in this final rule cannot be carried out by State or local
government or by the family because the rule pertains to the
enforcement of certain Federal laws and the administration of a Federal
program. While the Department agrees that family planning is important,
it does not agree that the final rule will negatively impact access to
family planning. On the contrary, more patients could have access to
services because of changes to the program. Commenters offer no
compelling evidence that this rule will increase unintended pregnancies
or decrease access to contraception.
Other commenters note that the Department previously has supported
legislation that increases access to family planning care and provides
necessary referrals. Commenters contend that the Department has
supported the personal agency of families and individuals over Federal
involvement in family activities in the past. Commenters contend that
the Department should be required to explain its change in position.
The Department is perplexed by these comments, since the Department
supports increased access to family planning services, promotes
informed care for patients, and encourages family participation in
family planning decisions. The final rule is designed to increase
access to family planning and referrals to maintain the health of the
patient. In fact, providing health care services to patients is of such
importance to the Department that it encourages grantees to either
provide comprehensive health services or maintain a close relationship
with those who do. The Department therefore rejects the premise of this
set of comments and concludes that it is not necessary to prepare a
Family Policymaking Assessment.
The Secretary certifies that this final rule has been assessed in
accordance with section 654 of the Treasury and General Government
Appropriations Act of 1999, Public Law 105-277, sec. 654, 112 Stat.
2681 (1998), and will not negatively affect family well-being.
G. Paperwork Reduction Act
This final rule contains information collection requirements (ICRs)
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520. A
description of these provisions is given in the following paragraphs
with an estimate of the annual burden, summarized in Table 3. To fairly
evaluate whether an information collection should be approved by OMB,
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (PRA), the
Department solicited comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
The Department solicited public comment on each of the required
issues under section 3506(c)(2)(A) of the PRA. The collections of
information required by the final rule relate to Sec. [thinsp]59.2
(Definitions), Sec. [thinsp]59.5 (What requirements must be met by a
family planning project?), Sec. [thinsp]59.7 (What criteria would the
Department of Health and Human Services use to decide which family
planning services projects to fund and in what amounts?), Sec. 59.13
(Standards of compliance with prohibition on abortion), Sec. 59.17
(Compliance with reporting requirements), and Sec. 59.18 (Appropriate
use of funds).
Section 59.2 would apply to situations where an unemancipated minor
wishes to receive services on a confidential basis and be considered on
the basis of her/his own resources, as would Sec. 59.5(a)(14). In such
cases, the Title X provider would be required to document in the
minor's medical records the specific actions taken by the provider to
encourage the minor to involve her/his family (including her/his
parents or guardian) in her/his decision to seek family planning
services. This documentation requirement would not apply if the Title X
provider (1) believes that the minor is a victim of child abuse or
incest and (2) has, consistent with applicable State or local law,
reported the situation to the relevant authorities. The reporting
requirement must be documented in the medical record.
Section 59.5 requires Title X providers to report, in grant
applications and in all required reports, information regarding
subrecipients and referral agencies and individuals, including a
detailed description of the extent of collaboration and a clear
explanation of how the grantee will ensure adequate oversight and
accountability; and to maintain records with respect to minors on the
specific actions taken to encourage family participation (or the reason
why such family participation was not encouraged).
Section[thinsp]59.7 requires Title X grant applicants to describe,
within their applications, their affirmative compliance with each
provision of the regulations governing the Title X program.
Section 59.13 requires Title X grantees to provide assurance
satisfactory to the Secretary that, as a Title X grantee, it does not
provide abortion and does not include abortion as a method of family
planning. This assurance will include, at a minimum, representations
(supported by documentary evidence where the Secretary requests it) as
to compliance with Sec. 59.13 and each of the requirements in Sec.
59.14 through Sec. 59.16.
Section 59.17 requires Title X grantees to provide appropriate
documentation or other assurance satisfactory to the Secretary that it
has in place and has implemented a plan to comply with all State and
local laws requiring notification or reporting of child abuse, child
molestation, sexual abuse, rape, incest, intimate partner violence, and
human trafficking. It also requires Title X grantees to maintain
records to demonstrate compliance with the requirements of Sec. 59.17,
and makes continuation of funding for Title X services contingent upon
demonstrating to the Secretary that the criteria have been met.
Lastly, Sec. 59.18 requires Title X grantees to give a detailed
accounting of use related to grant dollars, both in their applications
for funding, and within any annually required reporting, and to fully
account for, and justify, charges against the Title X grant.
Burden of Response: The Department is committed to leveraging
existing grant, contract, annual reporting, and other Departmental
forms where possible, rather than creating additional, separate forms
for grantees to sign. The Department anticipates two separate burdens
of response: (1) Assurance of compliance; and (2) documentation of
compliance.
The burden for the assurance of compliance is the cost of grantee
and/or subrecipient staff time to (a) review
[[Page 7786]]
the assurance language as well as the underlying language related to
stated requirements; (b) to review grantee and/or subrecipient policies
and procedures or to take other actions to assess grantee and/or
subrecipient compliance with the requirements to which the grantee and/
or subrecipient is required to assure compliance.
The labor cost would include a lawyer spending an average of 3
hours reviewing all assurances and a medical and health service manager
spending an average of one hour reviewing and signing the assurances at
each grantee and subrecipient. The Department estimates the number of
grantees and subrecipients at 1,208, based on 2016 number of Title X
grantees and subrecipients, as represented in Title X FPAR data. The
mean hourly wage (not including benefits and overhead) for these
occupations is $67.25 per hour for the lawyer and $52.58 for the
medical and health service manager, as noted in the table above. The
labor cost is $307,000 in the first year (($67.25 x 3 + $52.58 x 1) x
1,208 grantees and subrecipients). The Department estimates that the
cost, in subsequent years, would be $145,000, which would represent an
annual allotment of one hour for the lawyer and one hour for the
medical and health service manager (($67.25 x 1 + $52.58 x 1) x 1,208
grantees and subrecipients).
The Department estimates that all grantees and subrecipients will
review their organizational policies and procedures or take other
actions to self-assess compliance with applicable Title X requirements
each year, spending an average of 4 hours doing so. The labor cost is a
function of a lawyer spending an average of 3 hours and a medical and
health service manager spending an average of one hour. The labor cost
for self-assessing compliance, such as reviewing policies and
procedures, is a total of $307,000 each year (($67.25 x 3 + $52.58 x 1)
x 1,208 grantees and subrecipients).
The burden for the documentation of compliance is the cost of
grantee and/or subrecipient staff time to (a) document in a minor's
medical records actions taken to encourage the minor to involve parents
in family planning services and (b) complete reports regarding
information related to subrecipients, referral agencies and individuals
involved in the grantee's Title X project. The Department assumes that
a physician assistant would be used to document such compliance. The
mean hourly wage (not including benefits and overhead) for this
occupation is $49.08 per hour. The labor cost would require spending an
average of 10 minutes to make appropriate documentation in a minor's
medical records. Approximately 20% (800,000) of the 4 million Title X
clients are adolescents. The Department estimates that complying with
the requirement to encourage family participation will result in 75%
(600,000) of adolescent patients' medical records requiring appropriate
documentation. The labor cost will be $982,000 each year ($49.08 per
hour x 2 minutes x 600,000 adolescents).
The labor cost would also include a medical and health services
manager spending an average of four hours each year to complete reports
regarding information related to subrecipients involved in the
grantee's Title X project at each grantee and subrecipient. The labor
cost will be $254,000 each year ($52.58 per hour x 4 hours x 1,208
grantees and subrecipients).
Table 3--Annual Recordkeeping and Reporting Requirements or Burden of Response in Year One/Subsequent Years Upon Publication of the Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Burden per
Regulation burden OMB control No. Respondents Hourly rate response Total annual Labor cost of
responses ($) (hours) burden (hours) reporting ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Assurance of Compliance.................. NEW................... 1,208/1,208 63.58/62.36 8/6 9,664/7,248 614,000/452,000
Documentation of Compliance.............. NEW................... 1,208/1,208 52.58/52.58 4/4 4,832/4,832 254,000/254,000
Documentation on Minor's Medical Records. NEW................... 600,000/600,000 49.08/49.08 .03/.03 20,000/20,000 982,000/982,000
--------------------------------------------------------------------------------------
Total Cost........................... ...................... ................ .............. .............. .............. 1,850,000/1,688,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
The Department asked for public comment on the information
collection including what additional benefits may be cited as a result
of this rule. Where warranted, changes were made in the preceding
calculations of cost.
The Department has submitted a copy of this rule to OMB for its
review of the rule's information collection and recordkeeping
requirements. These requirements are not effective until they have been
approved by OMB.
List of Subjects in 42 CFR Part 59
Family planning, Grant programs--health, Grant programs--social
programs, Health professions, Reporting and recordkeeping requirements,
Youth, Health, Abortion, Birth control, Title X, Contraception, Natural
family planning, Infertility, Fertility awareness.
For the reasons set forth in the preamble, the Department of Health
and Human Services amends 42 CFR chapter I, subchapter D, part 59, as
set forth below:
PART 59--GRANTS FOR FAMILY PLANNING SERVICES
0
1. The authority citation for part 59 is revised to read as follows:
Authority: 42 U.S.C. 300 through 300a-6.
0
2. Revise Sec. 59.1 to read as follows:
Sec. 59.1 To what programs do these regulations apply?
(a) The regulations of this subpart are applicable to the award of
grants under section 1001 of the Public Health Service Act (42 U.S.C.
300) to assist in the establishment and operation of voluntary family
planning projects. These projects shall consist of the educational,
comprehensive medical, and social services necessary to aid individuals
to determine freely the number and spacing of their children. Unless
otherwise specified, the requirements imposed by these regulations
apply equally to grantees and subrecipients, and grantees shall require
and ensure that subrecipients (and the subrecipients of subrecipients)
comply with the requirements contained in these regulations pursuant to
their written contracts with such subrecipients.
(b) Except for Sec. Sec. 59.4, 59.8, and 59.10, the regulations of
this subpart are also applicable to the execution of contracts under
section 1001 of the Public Health Service Act (42 U.S.C. 300) to assist
in the establishment and operation of voluntary family planning
projects, and will be applied in accordance with the
[[Page 7787]]
applicable statutes, procedures and regulations that generally govern
Federal contracts. To this extent, the use of the terms ``grant'',
``award,'', ``grantee'' and ``subrecipient'' in applicable regulations
of this subpart will apply similarly to contracts, contractors and
subcontractors, and the use of the term ``project'' or ``program'' will
also apply to a project or program established by means of a contract.
0
3. Amend Sec. 59.2 by:
0
a. Adding in alphabetical order definitions for ``Advanced Practice
Provider'', ``Family Planning'' and ``Grantee'';
0
b. Revising the definition of ``Low income family''; and
0
c. Adding in alphabetical order definitions for ``Program and
project'', and ``Subrecipient''.
The additions and revision read as follows:
Sec. 59.2 Definitions.
* * * * *
Advanced Practice Provider means a medical professional who
receives at least a graduate level degree in the relevant medical field
and maintains a license to diagnose, treat, and counsel patients. The
term Advanced Practice Provider includes physician assistants and
advanced practice registered nurses (APRN). Examples of APRNs that are
an Advanced Practice Provider include certified nurse practitioner
(CNP), clinical nurse specialist (CNS), certified registered nurse
anesthetist (CRNA), and certified nurse-midwife (CNM).
* * * * *
Family planning means the voluntary process of identifying goals
and developing a plan for the number and spacing of children and the
means by which those goals may be achieved. These means include a broad
range of acceptable and effective family planning methods and services,
which may range from choosing not to have sex to the use of other
family planning methods and services to limit or enhance the likelihood
of conception (including contraceptive methods and natural family
planning or other fertility awareness-based methods) and the management
of infertility, including information about or referrals for adoption.
Family planning services include preconception counseling, education,
and general reproductive and fertility health care, in order to improve
maternal and infant outcomes, and the health of women, men, and
adolescents who seek family planning services, and the prevention,
diagnosis, and treatment of infections and diseases which may threaten
childbearing capability or the health of the individual, sexual
partners, and potential future children. Family planning methods and
services are never to be coercive and must always be strictly
voluntary. Family planning does not include postconception care
(including obstetric or prenatal care) or abortion as a method of
family planning. Family planning, as supported under this subpart,
should reduce the incidence of abortion.
Grantee means the entity that receives Federal financial assistance
by means of a grant, and assumes legal and financial responsibility and
accountability for the awarded funds, for the performance of the
activities approved for funding and for reporting required information
to the Office of Population Affairs.
Low income family means a family whose total income does not exceed
100% of the most recent Poverty Guidelines issued pursuant to 42 U.S.C.
9902(2). The project director may find that ``Low income family'' also
includes members of families whose annual income exceeds this amount,
but who, as determined by the project director, are unable, for good
reasons, to pay for family planning services. For example:
(1) Unemancipated minors who wish to receive services on a
confidential basis must be considered on the basis of their own
resources, provided that the Title X provider has documented in the
minor's medical records the specific actions taken by the provider to
encourage the minor to involve her/his family (including her/his
parents or guardian) in her/his decision to seek family planning
services, except that documentation of such encouragement is not to be
required if the Title X provider has documented in the medical record:
(i) That it suspects the minor to be the victim of child abuse or
incest; and
(ii) That it has, consistent with, and if permitted or required by,
applicable State or local law, reported the situation to the relevant
authorities.
(2) For the purpose of considering payment for contraceptive
services only, where a woman has health insurance coverage through an
employer that does not provide the contraceptive services sought by the
woman because the employer has a sincerely held religious or moral
objection to providing such coverage, the project director may consider
her insurance coverage status as a good reason why she is unable to pay
for contraceptive services. In making that determination, the project
director must also consider other circumstances affecting her ability
to pay, such as her total income. The project director may, for the
purpose of considering whether the woman is from a ``low income
family'' or is eligible for a discount for contraceptive services on
the schedule of discounts provided for in Sec. 59.5, consider her
annual income as being reduced by the total annual out-of-pocket costs
of contraceptive services she uses or seeks to use. The project
director may determine those costs, or estimate them at $600.
* * * * *
Program and project are used interchangeably and mean a plan or
sequence of activities that is funded to fulfill the requirements
elaborated in a Title X funding announcement; it may be comprised of,
and implemented by, a single grantee or subrecipient(s), or a group of
partnering providers who, under a grantee or subrecipient, deliver
comprehensive family planning services that satisfy the requirements of
the grant within a service area.
* * * * *
Subrecipient means any entity that provides family planning
services with Title X funds under a written agreement with a grantee or
another subrecipient. These entities may also be referred to as
``delegates'' or ``contract agencies.''
0
4. Revise Sec. 59.3 to read as follows:
Sec. 59.3 Who is eligible to apply for a family planning services
grant or contract?
Any public or nonprofit private entity in a State may apply for a
family planning grant or contract under this subpart.
0
5. Amend Sec. 59.5 by:
0
a. Revising paragraphs (a)(1) and (5);
0
b. Removing paragraph (a)(10)(i);
0
c. Redesignating paragraph (a)(10)(ii) as (a)(10);
0
d. Adding paragraphs (a)(12), (13), and (14); and
0
e. Revising paragraphs (b)(1) and (8).
The revisions and additions read as follows:
Sec. 59.5 What requirements must be met by a family planning project?
(a) * * *
(1) Provide a broad range of acceptable and effective family
planning methods (including contraceptives, natural family planning or
other fertility awareness-based methods) and services (including
infertility services, information about or referrals for adoption, and
services for adolescents). Such projects are not required to provide
every acceptable and effective family planning method or service. A
participating entity may offer only a single method or a limited number
of methods of family planning as long as the entire project offers a
broad range of such family planning methods and services.
* * * * *
[[Page 7788]]
(5) Not provide, promote, refer for, or support abortion as a
method of family planning.
* * * * *
(12) Should offer either comprehensive primary health services
onsite or have a robust referral linkage with primary health providers
who are in close physical proximity, to the Title X site, in order to
promote holistic health and provide seamless care.
(13) Ensure transparency in the delivery of services by reporting
the following information in grant applications and all required
reports:
(i) Subrecipients and agencies or individuals providing referral
services by name, location, expertise and services provided or to be
provided;
(ii) Detailed description of the extent of the collaboration with
subrecipients, referral agencies, and any individuals providing
referral services, in order to demonstrate a seamless continuum of care
for clients; and
(iii) Clear explanation of how the grantee will ensure adequate
oversight and accountability for quality and effectiveness of outcomes
among subrecipients.
(14) Encourage family participation in the decision to seek family
planning services; and, with respect to each minor patient, ensure that
the records maintained document the specific actions taken to encourage
such family participation (or the specific reason why such family
participation was not encouraged).
(b) * * *
(1) Provide for medical services related to family planning
(including physician's consultation, examination, prescription, and
continuing supervision, laboratory examination, contraceptive supplies)
and referral to other medical facilities when medically necessary,
consistent with Sec. [thinsp]59.14(a), and provide for the effective
usage of contraceptive devices and practices.
* * * * *
(8) Except as provided in Sec. [thinsp]59.14(a), provide for
coordination and use of referral arrangements with other providers of
health care services, local health and welfare departments, hospitals,
voluntary agencies, and health services projects supported by other
federal programs.
* * * * *
0
6. Amend Sec. 59.7 by:
0
a. Revising paragraph (a);
0
b. Redesignating paragraphs (b) and (c) as paragraphs (d) and (e); and
0
c. Adding new paragraphs (b), and (c).
The revisions and additions read as follows:
Sec. 59.7 What criteria will the Department of Health and Human
Services use to decide which family planning services projects to fund
and in what amount?
(a) Within the limits of funds available for these purposes, the
Secretary may award grants for the establishment and operation of those
projects which will, in the Department's judgment, best promote the
purposes of statutory provisions applicable to the Title X program, and
ensure that no Title X funds are used where abortion is a method of
family planning.
(b) Any grant applications that do not clearly address how the
proposal will satisfy the requirements of this regulation shall not
proceed to the competitive review process, but shall be deemed
ineligible for funding. The Department will explicitly summarize each
requirement of the Title X regulations or include the Title X
regulations in their entirety within the Funding Announcement, and
shall require each applicant to describe its plans for affirmative
compliance with each requirement.
(c) If the proposal is deemed compliant with this regulation, then
applicants will be subject to criteria for selection within the
competitive grant review process, including:
(1) The degree to which the applicant's project plan adheres to the
Title X statutory purpose and goals for the establishment and operation
of voluntary family planning projects which shall offer a broad range
of acceptable and effective family planning methods and services
(including natural family planning methods, infertility services, and
services for adolescents), while meeting all of the statutory and
regulatory requirements and restrictions, including that none of the
funds shall be used in programs where abortion is a method of family
planning.
(2) The degree to which the relative need of the applicant for
Federal funds is demonstrated in the proposal, and the applicant shows
capacity to make rapid and effective use of grant funds, including its
ability to procure a broad range of diverse subrecipients, as
applicable, in order to expand family planning services available to
patients in the project area.
(3) The degree to which the applicant takes into account the number
of patients, particularly low-income patients, to be served while also
targeting areas that are more sparsely populated and/or places in which
there are not adequate family planning services available.
(4) The extent to which family planning services are needed locally
and the applicant proposes innovative ways to provide services to
unserved or underserved communities.
* * * * *
0
7. Revise Sec. 59.11 to read as follows:
Sec. 59.11 Confidentiality.
All information as to personal facts and circumstances obtained by
the project staff about individuals receiving services must be held
confidential and not be disclosed without the individual's documented
consent, except as may be necessary to provide services to the patient
or as required by law, with appropriate safeguards for confidentiality;
concern with respect to the confidentiality of information, however,
may not be used as a rationale for noncompliance with laws requiring
notification or reporting of child abuse, child molestation, sexual
abuse, rape, incest, intimate partner violence, human trafficking, or
similar reporting laws. Otherwise, information may be disclosed only in
summary, statistical, or other form which does not identify particular
individuals.
0
8. Add Sec. 59.13 through Sec. 59.19 to subpart A to read as follows:
Sec.
* * * * *
59.13 Standards of compliance with prohibition on abortion.
59.14 Requirements and limitations with respect to post-conception
activities.
59.15 Maintenance of physical and financial separation.
59.16 Prohibition on activities that encourage, promote, or advocate
for abortion.
59.17 Compliance with reporting requirements.
59.18 Appropriate use of funds.
59.19 Transition provisions; compliance.
Sec. 59.13 Standards of compliance with prohibition on abortion.
A project may not receive funds under this subpart unless the
grantee provides assurance satisfactory to the Secretary that the
project does not provide abortion and does not include abortion as a
method of family planning. Such assurance must also include, at a
minimum, representations (supported by documentary evidence where the
Secretary requests it) as to compliance with this section and each of
the requirements in Sec. Sec. 59.14 through 59.16. A project supported
under this subpart must comply with such requirements at all times
during the project period.
Sec. 59.14 Requirements and limitations with respect to post-
conception activities.
(a) Prohibition on referral for abortion. A Title X project may not
perform, promote, refer for, or support abortion as a method of family
planning, nor take
[[Page 7789]]
any other affirmative action to assist a patient to secure such an
abortion.
(b) Information about prenatal care. (1) Because Title X funds are
intended only for family planning, once a client served by a Title X
project is medically verified as pregnant, she shall be referred to a
health care provider for medically necessary prenatal health care. The
Title X provider may also choose to provide the following counseling
and/or information to her:
(i) Nondirective pregnancy counseling, when provided by physicians
or advanced practice providers;
(ii) A list of licensed, qualified, comprehensive primary health
care providers (including providers of prenatal care);
(iii) Referral to social services or adoption agencies; and/or
(iv) Information about maintaining the health of the mother and
unborn child during pregnancy.
(2) In cases in which emergency care is required, the Title X
project shall only be required to refer the client immediately to an
appropriate provider of medical services needed to address the
emergency.
(c) Use of permitted lists or referrals to encourage abortion. (1)
A Title X project may not use the provision of any prenatal, social
service, emergency medical, or other referral, of any counseling, or of
any provider lists, as an indirect means of encouraging or promoting
abortion as a method of family planning.
(2) The list of licensed, qualified, comprehensive primary health
care providers (including providers of prenatal care) in paragraph
(b)(1)(ii) of this section may be limited to those that do not provide
abortion, or may include licensed, qualified, comprehensive primary
health care providers (including providers of prenatal care), some, but
not the majority, of which also provide abortion as part of their
comprehensive health care services. Neither the list nor project staff
may identify which providers on the list perform abortion.
(d) Provision of medically necessary information. Nothing in this
subpart shall be construed as prohibiting the provision of information
to a project client that is medically necessary to assess the risks and
benefits of different methods of contraception in the course of
selecting a method, provided that the provision of such information
does not promote abortion as a method of family planning.
(e) Examples. (1) A pregnant client of a Title X project
requests prenatal health care services. Because the provision of
such services is outside the scope of family planning supported by
Title X, the client is referred for prenatal care and may be
provided a list of licensed, qualified, comprehensive primary health
care providers (including providers of prenatal care). Provision of
a referral for prenatal health care is consistent with this part
because prenatal care is a medically necessary service.
(2) A Title X project discovers an ectopic pregnancy in the
course of conducting a physical examination of a client. Referral
arrangements for emergency medical care are immediately provided.
Such action complies with the requirements of paragraph (b) of this
section.
(3) After receiving nondirective counseling at a Title X
provider, a pregnant woman decides to have an abortion, is concerned
about her safety during the procedure, and asks the Title X project
to provide her with a referral to an abortion provider. The Title X
project tells her that it does not refer for abortion, but provides
the following: A list of licensed, qualified, comprehensive primary
health care providers (including providers of prenatal care), which
is not presented as a referral for abortion, but as a list of
comprehensive primary care and prenatal care providers that does not
identify which providers perform abortion, and the project staff
member does not identify such providers on the list; and information
about maintaining her health and the health of her unborn child
during pregnancy. Such actions comply with paragraphs (a) through
(c) of this section.
(4) A pregnant woman asks the Title X project to provide her
with a list of abortion providers in the area. The project tells her
that it does not refer for abortion, and provides her a list that
consists of hospitals and clinics and other providers, all of which
provide comprehensive primary health care (including prenatal care),
as well as abortion as a method of family planning. Although there
are several licensed, qualified, comprehensive primary health care
providers (including providers of prenatal care) in the area that do
not provide abortion as a method of family planning, none of these
providers is included on the list. Provision of the list is
inconsistent with paragraphs (a) and (c) of this section.
(5) A pregnant woman requests information on abortion and asks
the Title X project to refer her for an abortion. The counselor
tells her that the project does not consider abortion a method of
family planning and, therefore, does not refer for abortion. The
counselor offers her nondirective pregnancy counseling, which may
discuss abortion, but the counselor neither refers for, nor
encourages, abortion. The counselor further tells the client that
the project can help her to obtain prenatal care and necessary
social services and offers her the list of licensed, qualified,
comprehensive primary health care providers (including providers of
prenatal care), assistance, and information for pregnant women
described in paragraph (b) of this section. None of the providers on
the list provide abortions. Such actions are consistent with
paragraphs (a) through (c) of this section.
(6) Title X project staff provide contraceptive counseling to a
client in order to assist her in selecting a contraceptive method.
In discussing oral contraceptives, the project counselor provides
the client with information contained in the patient package insert
accompanying a brand of oral contraceptives, referring to abortion
only in the context of a discussion of the relative safety of
various contraceptive methods and in no way promoting abortion as a
method of family planning. The provision of this information is
consistent with paragraph (d) of this section and this section
generally and does not constitute an abortion referral.
Sec. 59.15 Maintenance of physical and financial separation.
A Title X project must be organized so that it is physically and
financially separate, as determined in accordance with the review
established in this section, from activities which are prohibited under
section 1008 of the Act and Sec. Sec. [thinsp]59.13, 59.14, and 59.16
of these regulations from inclusion in the Title X program. In order to
be physically and financially separate, a Title X project must have an
objective integrity and independence from prohibited activities. Mere
bookkeeping separation of Title X funds from other monies is not
sufficient. The Secretary will determine whether such objective
integrity and independence exist based on a review of facts and
circumstances. Factors relevant to this determination shall include:
(a) The existence of separate, accurate accounting records;
(b) The degree of separation from facilities (e.g., treatment,
consultation, examination and waiting rooms, office entrances and
exits, shared phone numbers, email addresses, educational services, and
websites) in which prohibited activities occur and the extent of such
prohibited activities;
(c) The existence of separate personnel, electronic or paper-based
health care records, and workstations; and
(d) The extent to which signs and other forms of identification of
the Title X project are present, and signs and material referencing or
promoting abortion are absent.
Sec. 59.16 Prohibition on activities that encourage, promote, or
advocate for abortion.
(a) Prohibition on activities that encourage abortion. (1) A Title
X project may not encourage, promote or advocate abortion as a method
of family planning. This restriction prohibits actions in the funded
project that assist women to obtain abortions for family planning
purposes or to increase the availability or accessibility of abortion
for family planning purposes.
[[Page 7790]]
(2) Prohibited actions include the use of Title X project funds for
the following:
(i) Lobbying for the passage of legislation to increase in any way
the availability of abortion as a method of family planning;
(ii) Providing speakers or educators who promote the use of
abortion as a method of family planning;
(iii) Attending events or conferences during which the grantee or
subrecipient engages in lobbying;
(iv) Paying dues to any group that, as a more than insignificant
part of its activities, advocates abortion as a method of family
planning and does not separately collect and segregate funds used for
lobbying purposes;
(v) Using legal action to make abortion available in any way as a
method of family planning; and
(vi) Developing or disseminating in any way materials (including
printed matter, audiovisual materials and web-based materials)
advocating abortion as a method of family planning.
(b) Examples. (1) Clients at a Title X project are given brochures
advertising a clinic that provides abortions, or such brochures are
available in any fashion at a Title X clinic (sitting on a table or
available or visible within the same space where Title X services are
provided). Provision or availability of the brochure violates paragraph
(a)(2)(vi) of this section.
(2) A Title X project makes an appointment for a pregnant client
for an abortion for family planning purposes. The Title X project has
violated paragraph (a)(1) of this section.
(3) A Title X project pays dues with project funds to a State
association that, among other activities, lobbies at State and local
levels for the passage of legislation to protect and expand the legal
availability of abortion as a method of family planning. The
association spends a significant amount of its annual budget on such
activity and does not separately collect and segregate the funds for
such purposes. Payment of dues to the association violates paragraph
(a)(2)(iv) of this section.
(4) An organization conducts a number of activities, including
operating a Title X project. The organization uses non-project funds to
pay dues to an association that, among other activities, engages in
lobbying to protect and expand the legal availability of abortion as a
method of family planning. The association spends a significant amount
of its annual budget on such activity. Payment of dues to the
association by the organization does not violate paragraph (a)(2)(iv)
of this section.
(5) An organization that operates a Title X project engages in
lobbying to increase the legal availability of abortion as a method of
family planning. The project itself engages in no such activities, and
the facilities and funds of the project are kept separate from
prohibited activities. The project is not in violation of paragraph
(a)(2)(i) of this section.
(6) Employees of a Title X project write their legislative
representatives in support of legislation seeking to expand the legal
availability of abortion, in their personal capacities and using no
project funds to do so. The Title X project has not violated paragraph
(a)(2)(i) of this section.
(7) On her own time and at her own expense, a Title X project
employee speaks before a legislative body in support of abortion as a
method of family planning. The Title X project has not violated
paragraph (a)(2)(i) of this section.
(8) A Title X project uses Title X funds for sex education classes
in a local high school. During the course of the class, information is
distributed to students that includes abortion as a method of family
planning. The Title X project has violated paragraph (a)(2)(vi) of this
section.
Sec. 59.17 Compliance with reporting requirements.
(a) Title X projects shall comply with all State and local laws
requiring notification or reporting of child abuse, child molestation,
sexual abuse, rape, incest, intimate partner violence or human
trafficking (collectively, ``State notification laws'').
(b) A project may not receive funds under this subpart unless it
provides appropriate documentation or other assurance satisfactory to
the Secretary that it:
(1) Has in place and implements a plan to comply with State
notification laws. Such plan shall include, at a minimum, policies and
procedures that include:
(i) A summary of obligations of the project or organizations and
individuals carrying out the project under State notification laws,
including any obligation to inquire about or determine the age of a
minor client or of a minor client's sexual partner(s);
(ii) Timely and adequate annual training of all individuals
(whether or not they are employees) serving clients for, or on behalf
of, the project regarding State notification laws; policies and
procedures of the Title X project and/or provider with respect to
notification and reporting of child abuse, child molestation, sexual
abuse, rape, incest, intimate partner violence and human trafficking;
appropriate interventions, strategies, and referrals to improve the
safety and current situation of the patient; and compliance with State
notification laws.
(iii) Protocols to ensure that every minor who presents for
treatment is provided counseling on how to resist attempts to coerce
them into engaging in sexual activities; and
(iv) Commitment to conduct a preliminary screening of any minor who
presents with a sexually transmitted disease (STD), pregnancy, or any
suspicion of abuse, in order to rule out victimization of a minor.
Projects are permitted to diagnose, test for, and treat STDs.
(2) Maintains records to demonstrate compliance with each of the
requirements set forth in paragraph (b)(1) of this section, including
which:
(i) Indicate the age of minor clients;
(ii) Indicate the age of the minor client's sexual partners if such
age is an element of a State notification law under which a report is
required; and
(iii) Document each notification or report made pursuant to such
State notification laws.
(c) Continuation of grantee or subrecipient funding for Title X
services is contingent upon demonstrating to the satisfaction of the
Secretary that the criteria have been met.
(d) The Secretary may review records maintained by a grantee or
subrecipient for the purpose of ensuring compliance with the
requirements of this section, the requirement to encourage family
participation in family planning decisions, or any other section of
this rule.
Sec. 59.18 Appropriate use of funds.
(a) Title X funds shall not be used to build infrastructure for
purposes prohibited with these funds, such as support for the abortion
business of a Title X grantee or subrecipient. Funds shall only be used
for the purposes, and in direct implementation of, the funded project,
expressly permitted by this regulation and authorized within section
1001 of the Public Health Service Act, that is, to offer family
planning methods and services. Grantees must use the majority of grant
funds to provide direct services to clients, and each grantee shall
provide a detailed plan or accounting for the use of grant dollars,
both in their applications for funding, and in any annually required
reporting. Any significant change in the use of grant funds within the
grant cycle shall not be undertaken without the approval of the Office
of Population Affairs.
[[Page 7791]]
(b) Title X funds shall not be expended for any activity (including
the publication or distribution of literature) that in any way tends to
promote public support or opposition to any legislative proposal or
candidate for office.
(c) Each project supported under Title X shall fully account for,
and justify, charges against the Title X grant. The Department shall
put additional protections in place to prevent possible misuse of Title
X funds through misbilling or overbilling, or any other unallowable
expense.
Sec. 59.19 Transition provisions; compliance.
(a) Compliance date concerning physical and financial separation.
The date by which covered entitites must comply with the physical
separation requirements contained in Sec. 59.15, is March 4, 2020. The
date by which covered entities must comply with the financial
separation requirements contained in Sec. 59.15 is July 2, 2019.
(b) Compliance date concerning applications. The date by which
covered entities must comply with Sec. 59.7 and 59.5(a)(13) (as it
applies to grant applications), is the date on which competitive or
continuation award applications are due, where that date occurs after
July 2, 2019.
(c) Compliance date concerning reporting, assurance, and provision
of service requirements. The date by which covered entities must comply
with Sec. Sec. 59.5(a)(12), 59.5(a)(13) (as it applies to all required
reports), 59.5(a)(14), (b)(1) and (8), 59.13, 59.14, 59.17, and 59.18gg
is July 2, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-03461 Filed 2-26-19; 4:15 pm]
BILLING CODE 5140-34-P