Compliance With Statutory Program Integrity Requirements, 7714-7791 [2019-03461]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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, ASH@hhs.gov, 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

[[Page 7718]]

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.
---------------------------------------------------------------------------

    \28\ See Rust, 500 U.S. at 193.
    \29\ Art. 1, sec. 8, cl. 1.
    \30\ See 42 U.S.C. 300a-4.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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/. ``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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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.'').
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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/. On that basis, fertility awareness-based 
methods of family planning could be said to be ``medically 
approved.''
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    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''.
---------------------------------------------------------------------------

    \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'').
---------------------------------------------------------------------------

    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).
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    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
    .
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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:
---------------------------------------------------------------------------

    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------

    \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.

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

[[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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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