Compliance With Statutory Program Integrity Requirements, 25502-25533 [2018-11673]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Proposed Rules]
[Pages 25502-25533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11673]



[[Page 25501]]

Vol. 83

Friday,

No. 106

June 1, 2018

Part II





Department of Health and Human Services





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42 CFR Part 59





Compliance With Statutory Program Integrity Requirements; Proposed Rule

Federal Register / Vol. 83 , No. 106 / Friday, June 1, 2018 / 
Proposed Rules

[[Page 25502]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 59

[Docket No.: 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.

ACTION: Proposed rule.

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SUMMARY: The Office of Population Affairs (OPA), in the Office of the 
Assistant Secretary for Health, proposes to revise its Title X 
regulations (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. In addition, OPA proposes amendments to the 
Title X regulations that would, among other things, clarify grantee 
responsibilities to provide a broad range of family planning methods; 
to require documented compliance with State and local laws requiring 
notification or the reporting of child abuse, child molestation, sexual 
abuse, rape, incest, intimate partner violence, and human trafficking; 
to provide free or low cost access to family planning services for 
those women who are unable to obtain employer-sponsored insurance 
coverage for certain contraceptive services due to their employers' 
religious beliefs or moral convictions; to provide for the appropriate 
expenditure of federal Title X funds on family planning services, 
rather than on lobbying or related activities; and to appropriately 
encourage family participation in family planning decisions, all as 
required by Federal law.

DATES: Comments on this proposed rule are invited. To be considered, 
comments must be received by July 31, 2018.

ADDRESSES: Written comments may be submitted to the Department of 
Health and Human Services, Office of the Assistant Secretary for 
Health, Office of Population Affairs, as specified below. Any comment 
that is submitted will also be made available to the public.
    Warning: Do not include any personally identifiable information 
(such as name, address, or other contact information) or confidential 
business information that you do not want publicly disclosed. All 
comments may be posted on the internet and can be retrieved by most 
internet search engines. No deletions, modifications, or redactions 
will be made to the comments received. Comments may be submitted 
anonymously.
    Comments, identified by ``Family Planning'' may be submitted by one 
of the following methods:
    Federal eRulemaking Portal: https://www.regulations.gov. Follow the 
instructions for submitting comments.
    Mail or Hand Delivery: Office of the Assistant Secretary for 
Health, Office of Population Affairs, Attention: Family Planning, U.S. 
Department of Health and Human Services, Hubert H. Humphrey Building, 
Room 716G, 200 Independence Avenue SW, Washington, DC 20201.
    Comments received will be posted without change to https://www.regulations.gov, including any personal information provided.

FOR FURTHER INFORMATION CONTACT: Valerie Huber at (202) 690-7694.

SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory Requirements of Title X of the Public Health Service Act 
and the Title X Appropriations Acts

    Title X of the Public Health Service Act (PHS Act or the Act), 42 
U.S.C. 300 through 300a-6, was enacted in 1970 by Public Law 91-572. 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).'' PHS Act sec. 1001(a); 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.\1\ 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 determine the number and 
spacing of children.
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    \1\ Fowler, C. I., Gable, J., Wang, J., & Lasater, B. Family 
Planning Annual Report: 2016 National Summary (Aug. 2017), https://www.hhs.gov/opa/sites/default/files/title-x-fpar-2016-national.pdf.
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    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.

The Conference Report described the intent 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 provisos, reiterated this 
requirement: ``[A]mounts provided to said [voluntary family planning] 
projects, under such title shall not be expended for abortions.'' See, 
e.g., Consolidated Appropriations Act, 2018, Public Law 115-141, Div. 
H, Title II, 132 Stat. 348, 716 (2018); Consolidated Appropriations 
Act, 2017, Public Law 115-31, Div. H, Title II, 131 Stat. 135, 521 
(2017); Consolidated Appropriations Act, 2016, Public Law 114-113, Div. 
H, Title II, 129 Stat. 2242, 2602 (2015).

    Since it originally created the Title X program in 1970, Congress 
has, from time to time, imposed additional requirements on it. For 
example, the annual Title X appropriation includes the provisos that 
``all pregnancy counseling shall be nondirective'' \2\ and 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.'' \3\ See, e.g., Consolidated 
Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, 132 
Stat. 348, 716-717 (2018); Consolidated Appropriations Act, 2017, 
Public Law 115-31, Div. H, Title II, 131 Stat. 135, 521 (2017).
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    \2\ See Omnibus Consolidated Rescissions and Appropriations Act, 
1996, Public Law 104-134, Title II, 110 Stat.1321, 1321-221 (1996).
    \3\ See Omnibus Consolidated Rescissions and Appropriations Act, 
1996, Public Law 104-134, Title II, 110 Stat.1321, 1321-221 (1996).
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    Congress has given particular instructions for the services 
provided under Title X to minors and other vulnerable populations. 
Congress specifically required that Title X provide distinct services 
for adolescents. See PHS Act sec. 1001(a), 42 U.S.C. 300(a) 
(requirement to provide

[[Page 25503]]

``a broad range of acceptable and effective family planning methods and 
services (including . . . services for adolescents)''). Congress also 
amended Title X in 1981 to require that, ``[t]o the extent practicable, 
entities which receive grants or contracts under this subsection shall 
encourage familiy [sic] participation in projects under this 
subsection.'' Omnibus Budget Reconciliation Act of 1981, Public Law 97-
35, sec. 931(b)(1), 95 Stat. 357, 570 (1981); PHS Act sec. 1001(a), 42 
U.S.C. 300(a). Since 1997,\4\ Congress has included 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.'' Consolidated 
Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 207, 132 
Stat. 348, 736 (2018). The same appropriations rider also requires that 
such an applicant certify to the Secretary that it ``provides 
counseling to minors on how to resist attempts to coerce minors into 
engaging in sexual activities.'' Id. By means of another rider, 
Congress requires 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.'' Consolidated 
Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 208, 132 
Stat. 348, 736 (2018).
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    \4\ See 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 (1997).
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B. Title X Regulations

    Since 1971, the Department has repeatedly exercised rulemaking 
authority with respect to the Title X program. Section 1006(a) of the 
Act, 42 U.S.C. 300a-4, grants rulemaking power to the Department: It 
provides that ``[g]rants and contracts made under this subchapter shall 
be made in accordance with such regulations as the Secretary may 
promulgate.'' The Department began to exercise that authority by 
issuing regulations implementing section 1008 in 1971. See 36 FR 18465 
(Sept. 15, 1971). Although those regulations, and revised regulations 
issued in 1980 (45 FR 37436 (June 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 provide further 
guidance on the application of that prohibition. In 1982, the 
Department's Office of Inspector General (OIG) audited 32 Title X 
clinics and found that the Department's failure to provide such 
guidance had created confusion about precisely what activities were 
proscribed by the section and resulted in variations in practice among 
grantees.\5\ The General Accounting Office (GAO, now the Government 
Accountability Office) recommended that ``the Secretary establish clear 
operational guidance by incorporating into the Title X program 
regulations and guidelines, HHS' position on the scope of the abortion 
restriction in section 1008.'' \6\
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    \5\ HHS OIG, Review of PHS Title X Family Planning Grantees, 
Audit Control No. 12-33177 (Nov. 18, 1982).
    \6\ GAO, No. HRD-82-106, Restrictions on Abortion and Lobbying 
Activities in Family Planning Programs Need Clarification, at 22 
(Sept. 24, 1982), https://www.gao.gov/assets/140/138760.pdf.
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1. 1988 Regulations and Rust v. Sullivan
    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. The Department noted ``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.'' 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, Final Rule, 53 FR 2922, 2923 (Feb. 2, 1988). The 
Department sought to address this deficiency.
    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 any abortion activities; and implemented compliance 
standards for family planning projects under Title X to specifically 
prohibit certain actions that promote or 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. 53 FR 2922 (Feb. 2, 1988).
    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). The Court first rejected the claim that 
the regulations violated the Administrative Procedure Act. Under 
Chevron U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837 
(1984), the Supreme Court reasoned that ``substantial deference'' was 
owed ``to the interpretation of the authorizing statute by the agency 
authorized with administering it.'' Rust, 500 U.S. at 184. Applying 
that framework, the Court concluded that--although the language of 
section 1008 did not speak directly to the issues of counseling, 
referral, advocacy, or program integrity--because the ``broad language 
of Title X plainly allows the Secretary's construction of the statute, 
. . . we are unable to say that the Secretary's construction of the 
prohibition in Sec.  1008 to require a ban on counseling, referral, and 
advocacy within the Title X project is impermissible.'' Id. The Court 
similarly declined to view the regulations skeptically because they 
represented a change in policy; instead, it 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. at 186-87. 
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.' '' Id. (internal citations omitted). Finally, 
the Supreme 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. 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 Sec.  1008, cannot be judged unreasonable.'' 
Id. at 190. Accordingly, the Court ``defer[red] to the Secretary's 
reasoned determination

[[Page 25504]]

that the program integrity requirements are necessary to implement the 
prohibition.'' Id.
    The Supreme 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 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.' '' Rust, 500 U.S. at 192 (internal citations omitted; ellipsis 
in original). The Court explained that the counseling and referral 
provisions were consistent with the First Amendment as follows:

    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.

Rust, 500 U.S. at 193-94. The Court also explained that the requirement 
of physical and financial program separation was consistent with the 
First Amendment as follows:

    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 the public fisc, and the 
Secretary has simply required a certain degree of separation from 
the Title X project in order to ensure the integrity of the 
federally funded program.

Rust, 500 U.S. at 198. Finally, 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.
2. Suspension of 1988 Regulations and Finalization of 2000 Regulations
    The 1988 Regulations continued to govern the Title X program until 
February 5, 1993, when a new Administration suspended them pursuant to 
a Presidential Memorandum and issued a proposed regulation, 58 FR 7464, 
that it finalized seven years later, see 65 FR 41270 (July 3, 2000) 
(the ``2000 Regulations''). The 2000 Regulations essentially returned 
to the 1981 Regulations (with one revision), which eliminated 
provisions (a) prohibiting Title X projects from counseling or 
referring project clients for abortion as a method of family planning; 
(b) requiring grantees to separate their Title X project physically and 
financially from any abortion activities; and (c) implementing 
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 were necessary to separate Title X project 
activities from non-Title X abortion activities, it 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 affirmatively required that Title X 
providers counsel on, and refer for, abortion at the request of a Title 
X client.
    Finally, the 2000 Regulations ``incorporated in the regulatory text 
the policies relating to nondirective counseling and referral of the 
1981 Program Guidelines for Project Grants for Family Planning Services 
[1981 Guidelines].'' 65 FR at 41271. Those 1981 Guidelines, for the 
first time, required nondirective counseling about pregnancy options, 
including abortion, and did so in a way that ``creat[ed] the appearance 
of treating each option identically,'' despite the statutory 
prohibition on funding programs where abortion is a method of family 
planning. See 53 FR at 2923 (discussing requirements imposed by 1981 
guidelines).
3. 2016 Regulation
    On December 19, 2016, the Department finalized a rule that amended 
Title X eligibility requirements, requiring that no grantee/recipient 
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 (Dec. 19, 
2016) (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. 
To that end, the Department asserted that ``[a]llowing project 
recipients, including states and other entities, to impose restrictions 
on subrecipients for reasons other than their ability to provide Title 
X services has been shown to have an adverse effect on the number of 
people receiving Title X services and the fundamental goals of the 
Title X program.''
    Yet the 2016 Regulation, if implemented, would have entailed 
certain adverse consequences. As an initial matter, it would have 
denied States and other grantees the freedom to choose subrecipients as 
they saw fit, within the Title X statutory parameters. Moreover, it 
could have resulted in the discontinuation of funding for entire 
States. A comment from the chief legal officers and/or governors from 
nine States explained their opposition to the rule as follows: ``[The 
purpose of Title X is] to promote and assist in the establishment of 
voluntary family planning projects that offer a broad range of 
acceptable and effective family planning methods and services. The 
program is also targeted toward services for adolescents. This rule 
does not further that goal; but rather it is intended to protect 
funding for certain providers even at the expense of the entire 
program.''
    The 2016 Regulation took effect on January 18, 2017, but was 
nullified under the Congressional Review Act less than three months 
later. The President signed Public Law 115-23, ``Providing for 
congressional disapproval under chapter 8 of title 5, United States 
Code, of the final rule submitted by Secretary of Health and Human 
Services relating to compliance with Title X requirements by project 
recipients in selecting subrecipients'' on April 13, 2017. As a result, 
the 2016 Regulation must be ``treated as though such rule had never 
taken effect.'' 5

[[Page 25505]]

U.S.C. 801(f). Because of the joint resolution of disapproval, the 
Department is prohibited from reissuing the nullified 2016 Regulation 
in ``substantially the same form'' or issuing a ``new rule that is 
substantially the same'' as the nullified 2016 Regulation. 5 U.S.C. 
801(b).

II. Need for Change

    The Department must consider the effectiveness of its policies 
enforcing statutory mandates on a continuing basis. As the Supreme 
Court noted in Rust v. Sullivan, an 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. 173, 186-87 (1991). ``Agencies are free to 
change their existing policies as long as they provide a reasoned 
explanation for the change.'' Encino Motorcars, LLC v. Navarro, 136 S. 
Ct. 2117, 2125 (2016). This ``reasoned analysis'' requirement does not 
demand that an agency ``demonstrate to a court's satisfaction that the 
reasons for the new policy are better than the reasons for the old one; 
it suffices that the new policy is permissible under the statute, that 
there are good reasons for it, and that the agency believes it to be 
better, which the conscious change of course adequately indicates.'' 
U.S. Aid Funds, Inc. v. King, 200 F. Supp. 3d 163, 169-70 (D.D.C. 2016) 
(citing FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 
(2009)); see also New Edge Network, Inc. v. FCC, 461 F.3d 1105, 1112-13 
(9th Cir. 2006) (rejecting an argument that ``an agency changing its 
course by rescinding a rule is obligated to supply a reasoned analysis 
for the change beyond that which may be required when an agency does 
not act in the first instance'').
    The Department now believes the policies outlined in this proposed 
rule are based on the best interpretation of, and provide appropriate 
guidance for compliance with, Title X. In particular, the Department 
believes that the policies outlined in this proposed rule provide for 
the best interpretation of section 1008 of Title X and of associated 
provisions, including the appropriations provisos and riders governing 
the Title X program. The standards proposed here are 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 pregnant women must be referred for 
appropriate prenatal care services, rather than receiving them within a 
Title X project, because those services are not part of family planning 
services within the Title X program. See H.R. Rep. No. 91-1472 (1970), 
as reprinted in 3 U.S. Code Cong. & Adm. News 5068 (discussing the 
scope of the program).

A. Statutory Compliance

    As discussed in section II.B. below, the Department interprets 
section 1008 to establish a broad prohibition on funding, directly or 
indirectly, activities related to abortion as a method of family 
planning. Thus, the Department believes that section 1008's mandate is 
most clearly met where there is a clear separation between Title X 
programs and programs in which abortion is presented or provided as a 
method of family planning. The 2000 regulations are inconsistent with 
that interpretation insofar as they require referral for abortion, 
allow the use of funds for infrastructure building that could be used 
for abortion services, and do not require clear physical and financial 
separation between Title X activities and abortion-related services. In 
addition, the regulations do not ensure transparency and accountability 
in the use of taxpayer funds insofar as they fail to provide the 
Department information about subrecipients, to ensure monitoring for 
potential misuse of funds, and to address expressly federal laws 
(including a Title X specific appropriations proviso) that prohibit the 
use of taxpayer funds for political activity or lobbying. Finally, the 
regulations prescribe inadequate grant criteria for selecting 
recipients of Title X funds who will comply with all of these 
requirements. If finalized and implemented as proposed, the new 
regulations would 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.

B. Ensuring That Title X Funds Are Not Used in Projects Where Abortion 
Is a Method of Family Planning

    As part of its ongoing obligation to ensure compliance with federal 
law, the Department has determined that the existing regulations do not 
ensure compliance with the prohibition in section 1008 that ``none of 
the funds appropriated'' for Title X ``be used in programs where 
abortion is a method of family planning.'' In the view of the 
Department, that prohibition includes any action that directly or 
indirectly facilitates, encourages, or supports in any way the use of 
abortion as a method of family planning. That interpretation follows 
from the text and purpose of the statute.
    To begin, section 1008 ``broad[ly]'' ``prohibits the use of Title X 
funds `in programs where abortion is a method of family planning.' '' 
Rust, 500 U.S. at 184. Although Title X does not define ``method of 
family planning,'' the ordinary meaning of that phrase, coupled with 
the statutory examples of ``natural family planning methods'' and 
``infertility services,'' 42 U.S.C. 300(a), suggests decisions about 
the number and spacing of one's children. This interpretation is 
consistent with the Title X regulation's description of the purpose of 
the program. See 42 CFR 59.1 (Title X voluntary family planning 
``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.''). And the exclusion of funding 
for abortion as a method for such decisions ``embodies a view that 
abortion is inappropriate as a method of family planning.'' 53 FR 2922, 
2922 (Feb. 2, 1988). Congress, thus, chose to fund Title X programs/
projects that offer only preconception methods of family planning and 
``create[d] a wall of separation between'' those programs and others 
where abortion is ``a method of family planning.'' 53 FR at 2922. The 
text of Title X's prohibition is also notably broad in prohibiting 
funding not only for providing and promoting abortion itself as a 
method of family planning, but in prohibiting funding for any program 
``where abortion is a method of family planning''--even if funds spent 
on such a program could be insulated from the provision or promotion of 
abortion.
    The legislative history confirms this meaning. The Conference 
Report stated that ``[i]t is, and has been, the intent of both Houses 
that the funds authorized under this legislation be used only to 
support preventive family planning services, population research, 
infertility services, and other related medical, information and 
education activities.'' H.R. Conf. Rep. No. 91-1667 at 8 (1970). 
Congressman John D. Dingell, Jr., the principal sponsor of section 
1008, further explained on the floor of the House:

    I set forth in my extended remarks the reasons why I offered to 
the amendment [sic], which prohibited abortion as a method of family 
planning. . . . With the ``prohibition of abortion'', the committee 
members clearly intended that abortion is not to be encouraged or 
promoted in any way through this legislation. Programs that include 
abortion as a method of family planning are

[[Page 25506]]

not eligible for funds allocated through this Act.

116 Cong. Rec. 37375 (1970).

    To give effect to Section 1008, the Department now considers it 
important and appropriate to draw a wall of separation between Title X 
programs and prohibited activities. Title X programs may not directly 
or indirectly facilitate, promote, or encourage abortion in any way. 
For example, referral is an integral part of the provision of any 
method of family planning. When provided for abortion, a referral 
necessarily treats abortion as a method of family planning and runs 
afoul of the statute. Similarly, Title X programs that subsidize other 
programs where abortion is a method of family planning, through 
infrastructure building, cost sharing, or otherwise, run afoul of the 
statute. Congress made clear that ``none'' of the Title X funds should 
go to support such programs.
    The Department previously took the position, in a notice published 
concurrently with the 2000 Regulations, that section 1008 precluded 
only funding of activities that ``directly facilitate the use of 
abortion as a method of family planning, such as providing 
transportation for an abortion, explaining and obtaining signed 
abortion consent forms from clients interested in abortions, 
negotiating a reduction in fees for an abortion, and scheduling or 
arranging for the performance of an abortion, promoting or advocating 
abortion within Title X program activities, or failing to preserve 
sufficient separation between Title X program activities and abortion-
related activities.'' Provision of Abortion-Related Services in Family 
Planning Services Projects, 65 FR 41281 (July 3, 2000) (``Notice''). 
The Department mandated that providers provide counseling on and 
referral for abortion, if requested by the client.
    But the Department no longer considers that position appropriate in 
light of restrictions set forth in the statute. Section 1008 does not 
merely prohibit ``direct'' funding for abortion. It prohibits all 
funding for programs ``where abortion is a method of family planning.'' 
That broad language captures not just the activities of the program 
itself, but also any activities facilitated, encouraged, or promoted by 
the program. Limiting section 1008's prohibition to only ``direct'' 
facilitation of abortion creates confusion about which activities are 
proscribed by the section, and, in the Department's view, fails to 
ensure that Title X funds are not being used in ``programs where 
abortion is a method of family planning.'' The Department's previous 
view was erroneous in requiring counseling and referral for abortion, 
allowing the sharing of physical space, and permitting infrastructure 
building when physical space could be shared. In these proposed 
regulations, the Department proposes to correct all three errors.
1. Abortion Counseling and Referral Requirement
    As discussed above, the Department has concluded the requirement 
under 42 CFR 59.5(a)(5) that a project must provide abortion counseling 
and referrals to pregnant women upon request is inconsistent with 
section 1008.\7\ That requirement appears to be premised on the notion 
that the statute is neutral on the question whether Title X funds may 
be used to encourage or promote abortion. But the Department rejects 
that notion: ``Family planning,'' as clearly manifested by the text of 
Title X and bolstered by its legislative history, refers to activities 
with the purpose of facilitating the initiation of, or preventing, 
pregnancy, not terminating it.\8\ Understood in context, referral 
activities are integral parts of the provision of any method of family 
planning. Thus, Section 1008 prohibits a Title X grantee, within the 
scope of the Title X project, from referring for abortion as a method 
of family planning. In the 2000 regulation, the Department took the 
position that the statute's requirement that pregnancy counseling be 
nondirective justified imposing a regulatory requirement of abortion 
referral upon request. The Department now believes this view was 
erroneous. Referrals for abortion are, by definition, directive. 
Therefore, such referral activity is inconsistent with the prohibition 
on abortion as a method of family planning in Section 1008.
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    \7\ 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 
activity that did not have the immediate effect of promoting 
abortion, or which did not have the principal purpose or effect of 
promoting abortion, was permitted. Id.
    \8\ Put differently, the family planning services covered by 
Title X are almost exclusively preconception services, while 
abortion is not.
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    In addition, the requirement that Title X projects offer pregnant 
women the opportunity to be provided information and counseling 
regarding, and referrals for, abortion is inconsistent with the 
conscience protections embodied in the Church, Coats-Snowe, and Weldon 
Amendments. See 42 U.S.C. 300a-7; PHS Act sec. 245, 42 U.S.C. 238n; 
Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 
507(d), 132 Stat. 348, 764 (2018); Consolidated Appropriations Act, 
2017, Public Law 115-31, Div. 507(d), 131 Stat. 135, 562 (2017). The 
Department acknowledged this problem in the preamble to 2008 
regulations implementing these conscience protections. Ensuring that 
Department of Health and Human Services Funds Do Not Support Coercive 
or Discriminatory Policies or Practices in Violation of Federal Law; 
Final Rule, 73 FR 78072 (Dec. 19, 2008). Responding to commenters who 
suggested that enforcing the conscience statutes would be inconsistent 
with the abortion referral requirements for family planning clinics in 
the Title X regulations, the Department observed, ``[w]ith regards 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.'' 73 FR at 78087.\9\ 
Although those 2008 conscience statute regulations were partially 
repealed in 2011, 76 FR 9968 (February 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. The abortion 
referral and counseling requirements in the current Title X 
regulations, thus, cannot be enforced against objecting grantees or 
applicants, and such requirements cannot be used to deny participation 
in the Title X program or a Title X project of objecting family 
planning providers.\10\
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    \9\ In January 2018, the Department issued a notice of proposed 
rulemaking to revise and expand these regulations. See Protecting 
Statutory Conscience Rights in Health Care; Delegation of Authority, 
83 FR 3880 (Jan. 26, 2018).
    \10\ We note that the Department has recently received a letter 
from the Attorney General of the State of Texas alleging 
discrimination against the State of Texas with respect to Title X, 
contending that the Department had improperly removed Texas from the 
list of eligible Title X grant recipients and referencing the 
protections embodied in the Church, Hyde/Weldon, and Coats/Snowe 
Amendments. Attorney General of Texas, Letter on Discrimination 
Against Texas Regarding Title X Grants (March 22, 2018), https://www.texasattorneygeneral.gov/files/epress/Texas_AG_letter_to_HHS_regarding_Title_X.pdf?cachebuster:96.

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[[Page 25507]]

    For these reasons, the Department proposes to change the Title X 
regulations to eliminate the requirement that Title X projects provide 
abortion referral and counseling. In addition, consistent with the 
purpose of the program, the proposed rule would prohibit recipients 
from using Title X funds to perform, promote, refer for, or support 
abortion as a method of family planning. This rule would better align 
with both the best reading of section 1008 and with the Federal 
conscience statutes. Recognizing, however, the duty of a physician to 
promote patient safety, a doctor would be permitted to provide 
nondirective counseling on abortion.\11\ Such nondirective counseling 
would not be considered encouragement, promotion, or advocacy of 
abortion as a method of family planning, as prohibited under section 
59.16 of this proposed rule. Moreover, as permitted by the 1988 
Regulations, a doctor would be permitted to provide a list of licensed, 
qualified, comprehensive health service providers, some (but not all) 
of which provide abortion in addition to comprehensive prenatal care. 
Providing such a list would be permitted only if a woman who is 
currently pregnant clearly states that she has already decided to have 
an abortion. This is discussed in more detail below, and the Department 
seeks public comment on this issue.
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    \11\ That counseling on abortion be nondirective is required by 
the appropriations law applicable to Title X. See Consolidated 
Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, 132 
Stat. at 716-17 (``all pregnancy counseling shall be 
nondirective'').
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2. Possible Co-Mingling of Funds Between Title X Projects and the 
Abortion Activities of the Title X Grantee/Subrecipient
    A second statutory problem is raised by the fact that the 2000 
Regulations required financial, but not physical, separation between 
Title X Projects and the abortion activities of the Title X grantee/
subrecipient. Organizations that actively include abortion as a method 
of family planning have consistently received Title X funding. The 2000 
regulations permit shared facilities, common staff, and single file 
systems between Title X supported activities and non-Title X abortion-
related activities in the following ways:

    (a) A common waiting room is permissible, as long as the costs 
[are] properly pro-rated; (b) common staff is permissible, so long 
as salaries are properly allocated and all abortion related 
activities of the staff members are performed in a program which is 
entirely separate from the Title X project; (c) a hospital offering 
abortions for family planning purposes and also housing a Title X 
project is permissible, as long as the abortion activities are 
sufficiently separate from the Title X project; and (d) maintenance 
of a single file system for abortion and family planning patients is 
permissible, so long as costs are properly allocated. 65 FR 41281, 
41282 (July 3, 2000).

These 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, and the appearance and perception that Title 
X funds being used in a given program may also be supporting that 
program's abortion activities. 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.

    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 
themselves be recipients of Title X funds. The Guttmacher Institute's 
recent report, Abortion Incidence and Service Availability in the 
United States, 2014, provides detail about the various types of 
facilities at which abortions are performed. 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. 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.'' It defines 
``abortion clinics'' as ``nonhospital facilities in which half or more 
of patient visits are for abortion services, regardless of annual 
abortion caseload.'' According to the Guttmacher Institute, 
nonspecialized clinics accounted for 24% of all abortions in 2008; \12\ 
31% in 2011; \13\ and 36% in 2014.\14\ In addition, nonspecialized 
clinics represented 26% of abortion providers in 2008; 30% in 2011; and 
31% in 2014. 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. 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.
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    \12\ Jones, R.K., Kooistra, K., Abortion incidence and access to 
services in the United States, 2008, Guttmacher Institute 
Perspectives on Sexual and Reproductive Health (Jan. 10, 2011), 
https://www.guttmacher.org/sites/default/files/article_files/4304111.pdf.
    \13\ Jones, R.K., Jerman, J., Abortion incidence and service 
availability in the United States, 2011, Guttmacher Institute 
Perspectives on Sexual and Reproductive Health (Feb. 3, 2014), 
https://www.guttmacher.org/sites/default/files/article_files/abortion_incidence_in_the_united_states_2011.pdf.
    \14\ Jones, R.K., Jerman, J., Abortion incidence and service 
availability in the United States, 2014, Guttmacher Institute 
Perspectives on Sexual and Reproductive Health (Jan. 17, 2017), 
https://www.guttmacher.org/sites/default/files/article_files/abortion-incidence-us.pdf.
---------------------------------------------------------------------------

    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, whether Title X projects provide 
abortion services, and whether the Federal government (and, ultimately, 
Federal taxpayers), is funding abortion services provided by 
organizations that are recipients (or subrecipients) of Title X grants/
funds. The Department believes that such potential co-mingling and 
confusion is evidence that the 2000 Regulations neither adequately 
reflect nor further the text and purpose of section 1008. As discussed 
above, the Department interprets section 1008 to require Title X 
project activities to be separate and distinct from non-Title X 
abortion activities. Thus, when a grantee 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 proposed regulation would reduce, and potentially eliminate, 
any confusion--actual or potential--as to the scope of services 
supported by Title X funds by requiring Title X projects to maintain 
clear physical and financial program separation from programs that use 
abortion as a method of family planning. This bright-line rule would 
create a clearer, more transparent system of separation and 
accountability, similar to that established by the 1988 Regulations and 
affirmed by the Supreme Court in Rust. It would also assure fidelity to 
the text and purpose of section 1008, and facilitate auditing and 
enforcement of program requirements. The proposed rule would not, 
however, restrict the use of non-Title X funds outside the Title X 
program, nor would it impose restrictions on funds provided by other

[[Page 25508]]

Federal programs. And it would not prevent a woman from seeking and 
obtaining an abortion. It would only draw a bright line between 
permissible services provided with Title X funds and services that 
cannot be so provided.
3. Infrastructure Building That Creates Fungibility Concerns Related to 
Abortion Services
    The current flexibility in the use of Title X funds raises 
additional concerns about the fungibility of assets that could be 
used--sometimes with an attendant increase in marginal cost--to build 
infrastructure for abortion services. By law, Title X providers must 
secure other sources of revenue to leverage Title X grants. See 42 CFR 
59.7(c) (``No grant may be made for an amount equal to 100 percent for 
the project's estimated costs.''). Medicaid is the primary source of 
additional revenue. But unlike Title X, which is a grant program, 
Medicaid is a reimbursement program. 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 recipients 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.\15\
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    \15\ Sonfield, A., Hasstedt, K., Gold, R. B., Moving forward. 
Family planning in the era of health reform, Guttmacher Institute 
(March 2014), https://www.guttmacher.org/report/moving-forward-family-planning-era-health-reform.

In another 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 Medicaid reimbursement for 
the clients they serve.\16\
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    \16\ Gold, R. B., Stronger Together: Medicaid, Title X Bring 
Different Strengths to Family Planning Effort, Guttmacher Institute 
(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 from 
Guttmacher in the report Stronger Together: Medicaid, Title X Bring 
---------------------------------------------------------------------------
Different Strengths to Family Planning Effort reinforces the point:

    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 service has as well.
    The proposed physical and financial separation of Title X projects 
from all activities that could not be funded by those programs, as well 
as the separate provision addressing the use of Title X funds for 
infrastructure purposes, would address this concern. 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.

C. Ensuring Responsible Use of Taxpayer Funds

    In addition to ensuring compliance with section 1008, the 
Department seeks to address three additional concerns posed by the 2000 
regulations with respect to the responsible use of taxpayer funds.
1. Ensuring Transparency of Subrecipients of Funds To Assist Oversight 
and Enforcement Efforts
    Transparency in the use of governmental funds is an important 
principle for responsible government. This transparency helps to ensure 
accountability for, and wise use of, taxpayers' money. Current Title X 
regulations, however, do not require grantees to submit information to 
the government about their subrecipients, referral agencies, or other 
partners to whom Title X funds may flow. This lack of information is a 
barrier to OPA's oversight of the activities of its program

[[Page 25509]]

and project subrecipients and, ultimately, to governmental 
accountability for those funds.
    Therefore, under the new regulations, Title X grant applicants 
would be required to share the following within their applications and, 
if funded, in required reports and responses to performance measures, 
wherever practicable:
     Names and locations of subrecipients, referral individuals 
and agencies, as well as services provided and to be provided by those 
entities;
     Detailed descriptions of any partnerships, including the 
extent of collaboration, with subrecipients, referral individuals and 
agencies, as well as less formal partners within the community, in 
order to demonstrate a seamless continuum of care for clients;
     A clear explanation of how the grantee will ensure 
adequate oversight and accountability for quality and effectiveness 
outcomes among subrecipients and those who serve as referrals for 
ancillary or core services.
2. Expanding Monitoring of the Use of Title X Funds
    The Department has additional concerns about the potential for 
misuse of Title X funds and misbilling or overbilling of other Federal 
or state programs by Title X grantees under the current regulatory 
scheme. Although Title X is the only discrete domestic family planning 
grant program, other programs also fund family planning. In fact, 75% 
of all family planning services are funded through Medicaid; only 10% 
are funded through Title X.\17\ Not infrequently, Title X grant 
recipients also claim Medicaid reimbursement for services they provide 
to clients. In fact, according to the National Family Planning & 
Reproductive Health Association, ``Medicaid is by far the largest 
revenue stream for the Title X provider network, comprising 40% of an 
average funding mix [and] is also the fastest growing revenue stream.'' 
\18\ It is not inconsequential, then, to note cases of misuse/
overbilling with respect to reimbursement for family planning services.
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    \17\ Hasstedt, K., Sonfield, A., Gold, R.B. Public funding for 
family planning and abortion services, FY 1980-2015, Guttmacher 
Institute (April 2017), https://www.guttmacher.org/report/public-funding-family-planning-abortion-services-fy-1980-2015.
    \18\ Hays B., Title X in Context, National Family Planning & 
Reproductive Health Association (July 2016), https://
www.nationalfamilyplanning.org/file/documents_-policy-briefs/Title-
X-in-Context.pdf.
---------------------------------------------------------------------------

    Numerous studies have documented misuse/overbilling for family 
planning services. The HHS Office of Inspector General (OIG) conducted 
a Federal audit of Medicaid-reimbursed claims for family planning 
services in New York State and found that about 25% of a sample of such 
claims were not eligible for Family Planning Benefit Program (FPBP) 
reimbursements.\19\ Overall, 61 Federal audits conducted by the 
Department's OIG found overbilling among Medicaid providers. On 
average, at least 14% of the Federal share of funding was overbilled by 
providers, with one provider overbilling at least 54% of the Federal 
share.\20\ Although misuse among Medicaid recipients does not 
necessarily predict or imply misuse of grant funds among Title X 
grantees, the Department is aware of specific examples of misuse/
overbilling by such grantees. For example:
---------------------------------------------------------------------------

    \19\ HHS OIG, Review of Federal Medicaid Claims Made for 
Beneficiaries in the Family Planning Benefit Program in New York 
State, Report No. A-02-07-01001 (May 22, 2008), https://oig.hhs.gov/oas/reports/region2/20701001.htm.
    \20\ Foster, C.G., 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.
---------------------------------------------------------------------------

     In New York State, one Medicaid provider was found to have 
received significant overpayments for family planning services.\21\ The 
same provider, also a Title X grantee,\22\ was found by the Health 
Resources and Services Administration (HRSA) to be in billing violation 
during a program integrity audit.\23\
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    \21\ Letter, State of New York Office of the Medicaid Inspector 
General, ``Letter on Family Planning Chargeback to Managed Care 
Network Providers, Final Report, Audit # 09-1415, Provider #---,'' -
-- (June 10, 2009).
    \22\ Philipson, D., Letter to the editor: Title X initiative 
threatens to affect the well-being of our communities, The 
Rivertowns Enterprise (Apr. 1, 2011), https://www.plannedparenthood.org/planned-parenthood-hudson-peconic/newsroom/letter-editor-title-x-initiative-threatens-affect-well-being-our-communities-rivertowns-enterpr.
    \23\ HRSA, Program Integrity: FY13 audit results (2017), https://www.hrsa.gov/opa/programintegrity/auditresults/fy13results.html.
---------------------------------------------------------------------------

     A Medicaid provider, under threat of being terminated from 
the Illinois Medicaid program, was charged with overbilling for birth 
control.\24\ This same provider is a current Title X grant 
recipient.\25\
---------------------------------------------------------------------------

    \24\ Wang, A., Planned Parenthood Settles with Illinois on 
Medicaid Payments, Modern Healthcare (Sept. 6, 2012), https://www.modernhealthcare.com/article/20120906/INFO/309069993; Wang, A., 
Medicaid Probes Planned Parenthood Fees, Crain's Chicago Business 
(July 9, 2012), https://www.chicagobusiness.com/article/20120707/ISSUE01/307079977/medicaid-probes-planned-parenthood-of-illinois.
    \25\ Wang, A.L., Planned Parenthood settles with Illinois on 
Medicaid payments, Modern Healthcare (Sept. 6, 2012) https://www.modernhealthcare.com/article/20120906/INFO/309069993; HHS Office 
of Population Affairs, Title X family planning directory of grantees 
(2017), https://www.hhs.gov/opa/title-x-family-planning/title-x-grantees/.
---------------------------------------------------------------------------

     Another Title X recipient and Medicaid provider in 
Pennsylvania was found out of compliance by HRSA for overbilling.\26\
---------------------------------------------------------------------------

    \26\ HRSA, Program Integrity: FY2012 audit results (2017), 
https://www.hrsa.gov/opa/programintegrity/auditresults/fy12results.html.
---------------------------------------------------------------------------

     A Medicaid provider (and Title X grantee) in Washington 
State was audited following charges that it engaged in improper billing 
practices. The Washington Medicaid Fraud Control Unit investigated; as 
a result of the investigation, the grantee reimbursed the Medicaid 
program.\27\
---------------------------------------------------------------------------

    \27\ Stucke, J., Planned Parenthood undergoes leadership 
changes, audit, The Spokesman-Review (May 21, 2009), https://www.spokesman.com/stories/2009/may/21/planned-parenthood-undergoes-leadership-changes/. Referenced Audit # 09-04-08 of Yakima County, 
Washington.
---------------------------------------------------------------------------

     The state of Nebraska found that significant abortion-
related expenses were charged against the Title X grant by a 
subrecipient.\28\ The same subrecipient, also a Medicaid provider, was 
also charged with ``false, fraudulent, and/or ineligible claims for 
reimbursement'' to Medicaid.\29\ In addition, a sample of 10 payments 
to subrecipients was reviewed by the state of Nebraska; nine of the ten 
lacked documentation to support Title X reimbursement. The report 
stated: ``The Agency did not have adequate monitoring procedures to 
ensure payments to subrecipients were for allowable activities and 
costs.'' \30\
---------------------------------------------------------------------------

    \28\ Nebraska Auditor of Public Accounts, State of Nebraska 
Statewide single audit: Year ended June 20, 2015 (2016), https://www.auditors.nebraska.gov/APA_Reports/2016/SA200-03242016-July_1_2014_through_June_30_2015_Statewide_Single_Report.pdf.
    \29\ Second Amended Complaint, Thayer v. Planned Parenthood of 
the Heartland, No. 4:11-cv-00129 (S.D. Iowa, filed July 26, 2012).
    \30\ Nebraska Auditor of Public Accounts, State of Nebraska 
Statewide single audit: Year ended June 20, 2015 (Mar. 24, 2016), 
https://www.auditors.nebraska.gov/APA_Reports/2016/SA200-03242016-July_1_2014_through_June_30_2015_Statewide_Single_Report.pdf.
---------------------------------------------------------------------------

     In Wisconsin, an audit of a Title X grantee found Medicaid 
overbilling problems, including no proof of prescription, excessive 
reimbursements beyond what is allowable, and other irregularities.\31\
---------------------------------------------------------------------------

    \31\ Wisconsin Department of Health Services, Audit Reveals 
Significant Overpayments to Family Planning Clinics (Aug. 3, 2016), 
https://www.dhs.wisconsin.gov/news/releases/fp-summary-results.pdf.
---------------------------------------------------------------------------

     In Massachusetts, a Title X grantee was subject to an OIG 
investigation, where the grantee admitted to comingling Title X 
expenses with all

[[Page 25510]]

other family planning expenses, a clear violation of Federal 
requirements.\32\
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    \32\ HHS OIG, Audit of Tapestry Health Systems, Inc. Title X 
Financial Management Systems, Report No. A-01-99-01504 (May 2000), 
https://oig.hhs.gov/oas/reports/region1/19901504.pdf.
---------------------------------------------------------------------------

    These examples raise concerns about the integrity of the Title X 
program. While only a few of these cases involve documented misuse of 
Title X funds or violation of Title X's financial requirements, the 
Department is concerned these instances suggest that at least some 
recipients or subrecipients of Title X funds may not understand, and/or 
may not be in compliance with, requirements regarding the receipt or 
use of Federal funds, including Title X funds.
    More broadly, grantees from a variety of federal programs commonly 
fail to verify personnel costs with the actual time spent on the grant-
supported activities compared to time spent on non-grant functions by 
fully documenting time with personnel activity reports. In addition, it 
is not uncommon for project costs in federal reports to be inconsistent 
with time and status reports or bookkeeping ledgers, or for grantees to 
lack adequate documentation for the amount allocated to the grant for 
indirect costs. Yet infrastructure costs can benefit the organization 
generally, rather than only as it pertains to activities permitted 
under the grant project.\33\
---------------------------------------------------------------------------

    \33\ National Historical Publications and Records Commission, An 
introduction to financial management for grant recipients, National 
Archives (June 17, 2015) https://www.archives.gov/files/nhprc/pdfs/grant-financial-management.pdf.
---------------------------------------------------------------------------

    The Department believes it necessary to address this issue with 
expanded monitoring, reporting, transparency, and accountability 
requirements. Because of the specific statutory prohibitions and 
requirements imposed on Title X projects, and the regulatory 
requirement--both currently and as proposed--for financial separation, 
the Department does not believe that the general grants management 
requirements are sufficient to address the issue. Rather, the 
Department proposes specific requirements to ensure legal and ethical 
usage of taxpayer dollars. These requirements are discussed in greater 
detail below, but they include requiring programs to: Ensure compliance 
with statutory requirements; have a plan in place to demonstrate that 
grantees and subrecipients are aware of certain reporting requirements 
that apply in their state; provide adequate training with respect to 
those requirements; maintain records about clients for whom state 
reporting requirements apply; receive approval for any change in the 
usage of grant funds; and fully account for and justify charges against 
the Title X grant.
3. Enforcing Other Statutory Requirements on the Use of Title X Funds
    The current regulations also raise concerns about compliance with 
other federal laws that govern expenditures of taxpayer funds.
    In addition to the Anti-Lobby Act, 18 U.S.C. 1913, the Department's 
annual appropriations act establishes a comprehensive framework 
prohibiting the use of Federal funding, including Title X funds, for 
publicity and propaganda. One set of prohibitions applies across the 
Executive Branch: ``No part of any funds appropriated in this or any 
other Act shall be used by an agency of the executive branch, other 
than for normal and recognized executive-legislative relationships, for 
publicity or propaganda purposes, and for the preparation, distribution 
or use of any kit, pamphlet, booklet, publication, radio, television, 
or film presentation designed to support or defeat legislation pending 
before the Congress, except in presentation to the Congress itself.'' 
\34\ Another provision applies to federal contractors: ``No part of any 
appropriation . . . shall be used directly or indirectly, including by 
private contractor, for publicity or propaganda purposes within the 
United States not heretofore authorized by Congress.'' \35\
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    \34\ Consolidated Appropriations Act, 2018, Public Law 115-141, 
Div. E, sec. 715, 132 Stat. 348, 590 (2018).
    \35\ Consolidated Appropriations Act, 2018, Public Law 115-141, 
Div. E, sec. 718, 132 Stat. 348, 591 (2018).
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    Yet another provision, which expressly applies to the Departments 
of Labor, Health and Human Services, and Education, adds ``electronic 
communication'' and substitutes ``video'' for ``film'' in the list of 
prohibited media, sweeps into its ambit ``any State or local 
legislature or legislative body,'' and adds ``any proposed or pending 
legislation, administrative action, or order issued by the executive 
branch of any State or local government'' to the prohibited 
targets.\36\ This prohibition is coupled with the directive that no 
part of the Labor, HHS, and Education appropriation ``shall be used to 
pay the salary or expenses of any grant or contract recipient, or agent 
acting for such recipient'' who engages in a similar list of lobbying 
activities.\37\ The Appropriations Act also contains an explicit 
prohibition against the use of Title X funds ``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.\38\
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    \36\ Consolidated Appropriations Act, 2018, Public Law 115-141, 
Div. H, sec. 503(a), 132 Stat. 348, 762 (2018).
    \37\ Consolidated Appropriations Act, 2018, Public Law 115-141, 
Div. H, sec. 503(b), 132 Stat. 348, 763 (2018).
    \38\ Consolidated Appropriations Act, 2018, Public Law 115-141, 
Div. H, Title II, 132 Stat. 348, 716-717 (2018); Consolidated 
Appropriations Act, 2017, Pub. L. 115-31, Div. H, Title II, 131 
Stat. 135, 521 (2017).
---------------------------------------------------------------------------

    Finally, the Byrd Amendment applies to the recipients of Federal 
contracts, grants, or loans, as well as the funded parties to 
cooperative agreements. It prohibits them from using such funds to 
lobby in connection with the award, extension, continuation, renewal, 
amendment, or modification of the funding mechanism under which 
monetary assistance was received.\39\
---------------------------------------------------------------------------

    \39\ 31 U.S.C. 1352(a).
---------------------------------------------------------------------------

    The current regulations offer no guidance on the application of 
these restrictions to the Title X program. Yet these restrictions on 
the use of appropriated funds clearly 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. Without guidance from the Department, 
it is possible that Title X grantees could intentionally, or 
unintentionally and unknowingly, use Title X funds for prohibited 
lobbying or political activities, or use such funds to support or pay 
dues/association fees to organizations where a majority of funds are 
used for such purposes. Indeed, issues surrounding family planning and 
abortion are highly controversial and routinely the subject of debate 
and policy consideration in the political and legislative processes at 
the national, state and local levels. As a consequence, and even 
without consideration of violations of these requirements, it is 
important that recipients of Title X funds fully understand the 
statutory prohibition on the use of Federal funds for lobbying and 
political activity.
    The proposed rule would provide more explicit direction, in 
requiring Title X grantees to provide a written assurance that they 
both understand and agree to the prohibitions related to lobbying and 
political activity with the use of grant funds. Because of the specific 
statutory prohibitions applicable to Title X, and the regulatory 
requirement--both currently and as

[[Page 25511]]

proposed--of financial separation, the Department does not believe that 
the general grants management requirements would be sufficient to 
address the issue.

D. Inadequate Grant Review Criteria

    The current Title X regulations set forth application review 
criteria that give HHS significant flexibility in determining awards, 
but need to be updated to more fully ensure 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. The statute sets forth several factors that HHS shall take 
into account in making grants and contracts,\40\ but these factors are 
nonexclusive: The statute does not prohibit HHS from taking other 
factors into account and does not specify how much weight to attribute 
to each factor. The current regulations similarly contain a non-
exclusive list of application review criteria--which include, but go 
beyond the statutory criteria--and do not specify how much weight to 
attach to each factor, giving HHS discretion to vary the weighting of 
the criteria in its competitions.
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    \40\ Title X provides that, ``[i]n making grants and contracts 
under this section the Secretary shall take into account the number 
of patients to be served, the extent to which family planning 
services are needed locally, the relative need of the applicant and 
its capacity to make rapid and effective use of such assistance.'' 
PHS Act Sec. 1001(b); 42 U.S.C. 300(b).
---------------------------------------------------------------------------

    As a result, while the statute and current regulations give HHS 
discretion in considering and weighting factors, the application review 
criteria in the regulation could be more comprehensive and rigorous, so 
that the strongest prospective grantees are more likely to be selected, 
and less qualified applicants would be less likely to garner high 
scores. The Department is focused on ensuring compliance with the 
statutory Title X requirements (see 42 U.S.C. 300-300a-6; Consolidated 
Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, secs. 
207-08, 132 Stat. 348, 716-17, 736), including the program integrity 
provisions referenced elsewhere herein; expanding the type and nature 
of the Title X providers and ensuring the diversity of such providers, 
so as to fill gaps in 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. These 
goals, which are consistent with the statute and permissible under the 
existing regulations, would be best achieved by amending the 
regulations to more fully specify the application criteria, while still 
adhering to the statutory requirement that certain factors be 
considered and maintaining the Department's flexibility to consider 
other factors in making awards.
    Therefore, through the proposed rule, the Department seeks to 
achieve a two-fold goal:
    1. Update application review criteria to better achieve the 
statutory requirements and goals of Title X.
    2. Increase competition and rigor among applicants, encouraging 
broader and more diverse applicants and better ensuring the selection 
of quality applicants.
    The Department and OPA desire to award grants for the establishment 
and operation of those Title X projects that would best promote the 
purposes of Title X and meet the statutory requirements.
    The Department proposes revising the current application review 
criteria at 45 CFR 59.7 through this rulemaking process to establish 
the following criteria for selection of Title X grantees. Under this 
proposed regulation, any grant applications that do not clearly address 
how the proposal will satisfy the requirements of the regulation would 
not proceed to the competitive review process, but would be deemed 
ineligible for funding. The Department would explicitly summarize each 
provision of the regulation (or include the entire regulation) within 
the Funding Announcement, and would require applicants to describe 
their affirmative compliance with each provision. If a proposal is 
deemed compliant with the regulation, then applicants would be rated 
based on at least the following criteria for selection within the 
competitive grant review process:
    (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)'' (PHS Act Sec. 1001(a), 42 
U.S.C. 300(a)), which meet all of the statutory and regulatory 
requirements and restrictions, and where ``none of the funds . . . 
shall be used in programs where abortion is a method of family 
planning.'' (PHS Act Sec. 1008, 42 U.S.C. 300a-6).
    (2) The degree to which ``the relative need of the applicant'' (PHS 
Act Sec. 1001(b), 42 U.S.C. 300(b)) is demonstrated in the proposal, 
and the applicant shows capacity to ``make rapid and effective use'' 
(PHS Act Sec. 1001(b), 42 U.S.C. 300(b)), of grant funds, including and 
especially among a broad range of partners and diverse subrecipients 
and referral individuals and organizations, and among non-traditional 
Title X partnering organizations.
    (3) The degree to which the applicant takes into account ``the 
number of patients to be served'' (PHS Act Sec. 1001(b), 42 U.S.C. 
300(b)), 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'' (PHS Act Sec.1001(b), 42 U.S.C. 300(b)) and the applicant 
proposes innovative ways to provide services to unserved or underserved 
patients.
    The Department seeks public comment as to whether additional 
regulatory application review criteria may be necessary or advisable to 
implement the Department's interpretation of the statutory provisions 
applicable to Title X, in particular section 1008; to protect the 
rights of individuals and entities who decline to participate in 
abortion-related activities; or to ensure that all services funded 
through Title X offer optimal health benefits to clients of all ages. 
The Department also seeks public comment as to whether the protections 
and services funded through Title X are adequately implemented and 
clearly understood throughout the Title X program, in order to 
alleviate the current confusion, and avoid future confusion, among 
clients and the general public.

III. Statutory Authorities

    The Department has legal authority to amend Title X regulations on 
the requirements applicable to projects for family planning services 
under section 1006 of the Public Health Service Act, 42 U.S.C. 300a-4. 
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.'' The Department has repeatedly exercised 
that authority to issue regulations to guide Title X grantees in 
carrying out the program.
    The proposed regulations described below in the section-by-section 
discussion of the proposed rule would clarify, require compliance with, 
and provide for the enforcement of, statutory limitations and 
requirements placed on Title X projects and grantees. These

[[Page 25512]]

include section 1008 of the Act, which prohibits ``funds appropriated 
under this subchapter'' from being ``used in programs where abortion is 
a method of family planning'' and has been reiterated through annual 
appropriations provisos that ``amounts provided to said [voluntary 
family planning] projects, under such title shall not be expended for 
abortions.'' See, e.g., Consolidated Appropriations Act, 2018, Public 
Law 115-141, Div. H, Title II, 132 Stat. 348, 716 (2018); Consolidated 
Appropriations Act, 2017, Public Law 115-31, Div. H, Title II, 131 
Stat. 135, 521 (2017); Consolidated Appropriations Act, 2016, Public 
Law 114-113, Div. H, Title II, 129 Stat. 2242, 2602 (2015). They also 
include annual appropriations provisions directing that ``all pregnancy 
counseling shall be nondirective'' \41\ and 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.'' \42\ See, e.g., Consolidated Appropriations Act, 2018, 
Public Law 115-141, Div. H, Title II, 132 Stat. 348, 716-717 (2018).
---------------------------------------------------------------------------

    \41\ Consolidated Appropriations Act, 2018, Public Law 115-141, 
Div. H, Title II, 132 Stat. 348, 716 (2018). Nondirective counseling 
has been described in Congressional proceedings and debates 
throughout the years. For example, ``nondirective counseling is the 
provision of information on all available options without promoting, 
advocating, or encouraging one option over another.'' Congressional 
Record (1992, April 30). Family Planning Amendments Act of 1991, 
House of Representatives. 138 Cong. Rec. H2822-02, 1992 WL 86830. 
Non-directive counseling does not mean the Title X provider or 
counselor is uninvolved in the process, nor does it mean that 
counseling and education offer no direction, but that clients take 
an active role in processing their experiences and identifying the 
direction of the interaction. The Title X provider/counselor 
promotes the client's self-awareness and empowers the client to 
change and develop agency over personal circumstances, offering a 
range of options, consistent with the client's expressed need and 
with the statutory and regulatory requirements governing the Title X 
program.
    \42\ Public Law 107-116, Title II, 115 Stat. 2177, 2186 (2002). 
.
---------------------------------------------------------------------------

    The proposed regulations also would require compliance with, and 
provide for the enforcement of, statutory provisions applicable to the 
provision of family planning services to minors and other vulnerable 
populations. Title X itself requires that, ``[t]o the extent 
practicable, entities which receive grants or contracts under this 
subsection shall encourage familiy [sic] participation in projects 
under this subsection.'' Omnibus Budget Reconciliation Act of 1981, 
Public Law 97-35, sec. 931(b)(1), 95 Stat. 375, 570 (1981); 42 U.S.C. 
300(a). A rider in HHS's annual appropriations act adds 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.'' Consolidated 
Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 207, 132 
Stat. 348, 736 (2018). It also requires an applicant to certify that it 
``provides counseling to minors on how to resist attempts to coerce 
minors into engaging in sexual activities.'' Id. And another provision 
in the annual HHS appropriations act states 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.'' Consolidated Appropriations Act, 2018, Public Law 115-141, 
Div. H, sec. 208, 132 Stat. 348, 736 (2018).
    Finally, the proposed regulations would require compliance with, 
and provide for the enforcement of, several additional laws that 
protect the conscience rights of individuals and entities who decline 
to perform, participate in, or refer for abortions, including the 
Church Amendments (42 U.S.C. 300a-7), the Coats-Snowe Amendment 
(section 245 of the Public Health Service Act, 42 U.S.C. 238n), and the 
Weldon Amendment, see, e.g., Consolidated Appropriations Act, 2018, 
Public Law 115-141, Div. H, sec. 507(d), 132 Stat. 348, 764 (2018); 
Consolidated Appropriations Act, 2017, Public Law 115-31, Div. H, sec. 
507(d), 131 Stat. 135, 521 (2017) (collectively, the ``conscience 
statutes''). The Church Amendments, for example, prohibit grantees from 
discriminating in the employment of, or the extension of staff 
privileges to, any health care professional because she refused, 
because of her religious beliefs or moral convictions, to perform or 
assist in the performance of any lawful sterilization or abortion 
procedures. They 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 her religious beliefs or 
moral convictions.\43\ The Coats-Snowe Amendment prohibits the Federal 
government and any State or local government that receives Federal 
financial assistance from discriminating against any health care entity 
(including individual providers) on the basis that the entity refuses 
to, among other things, (1) receive training in induced abortion; (2) 
require or provide abortion training; (3) perform abortions; (4) 
provide referral for such abortions or abortion training; or (5) make 
arrangements for any such activities. See 42 U.S.C. 238n(a). And the 
Weldon Amendment prohibits funds made available in HHS's annual 
appropriations act from being ``made available to a Federal agency or 
program, or to a State or local government, if such agency, program, or 
government subjects any institutional or individual health care entity 
to discrimination on the basis that the health care entity does not 
provide, pay for, provide coverage of, or refer for abortions.'' It 
provides that `` `health care entity' includes an individual physician 
or other health care professional . . . .'' See, e.g., Consolidated 
Appropriations Act, 2018,

[[Page 25513]]

Public Law 115-141, Div. H, sec. 507(d), 132 Stat. 348, 764 (2018).
---------------------------------------------------------------------------

    \43\ In addition, section 300a-7(c)(1) provides that ``[n]o 
entity which receives a grant, contract, loan, or loan guarantee 
under the [Act] . . . may (A) discriminate in the employment, 
promotion, or termination of employment of any physician or other 
health care personnel, or (B) . . . in the extension of staff or 
other privileges to any physician or other health care personnel . . 
. because he refused to perform or assist in the performance of . . 
. [an] abortion'' on the grounds that doing so ``would be contrary 
to his religious beliefs or moral convictions . . . .'' 42 U.S.C. 
300a-7(c)(1). Section 300a-7(c)(2) provides that ``[n]o entity which 
receives . . . a grant or contract for biomedical or behavioral 
research under any program administered by [HHS]'' may discriminate 
in the employment of or the extension of staff privileges to any 
health care professional ``because he refused to perform or assist 
in the performance of'' ``any lawful health service'' based on 
religious belief or moral conviction. 42 U.S.C. 300a-7(c)(2). 
Section 300a-7(d) provides that ``[n]o individual [may] be required 
to perform or assist in the performance of any part of a health 
service program . . . funded in whole or in part under a program 
administered by the Secretary of Health and Human Services'' if 
doing so ``would be contrary to his religious beliefs or moral 
convictions.'' 42 U.S.C. 300a-7(d). Section 300a-7(e) prohibits any 
entity that receives funding under the PHS Act from denying 
admission to, or otherwise discriminating against, ``any applicant 
(including for internships and residencies) for training or study 
because of the applicant's reluctance . . . to counsel, suggest, 
recommend, assist, or in any way participate in the performance of 
abortions . . . contrary to or consistent with the applicant's 
religious beliefs or moral convictions.'' 42 U.S.C. 300a-7(e). In 
addition, section 300a-7(b) provides in part that ``[t]he receipt of 
any grant, contract, loan, or loan guarantee under the [PHS Act] . . 
. by any individual or entity does not authorize any court or any 
public official or other public authority to require'' (1) the 
individual to perform or assist in an abortion if it would be 
contrary to his/her religious beliefs or moral convictions; or (2) 
the entity to make its facilities available for abortions, if the 
performance of abortions in the facilities is prohibited by the 
entity on the basis of religious beliefs or moral convictions, or 
provide personnel for the performance of abortions if it would be 
contrary to the religious beliefs or moral convictions of such 
personnel. 42 U.S.C. 300a-7(b).
---------------------------------------------------------------------------

IV. Provisions of the Proposed Rule

A. Section 59.1 To what programs do these regulations apply?

    Under federal law, including Title X, subrecipients of federal 
funds who agree to assist a primary grantee in implementing the grant 
project are required to comply with the same requirements that are 
imposed on the grantee. In order to ensure clarity and full 
implementation of the requirements of Title X and its implementing 
regulations, the Secretary proposes to amend Sec.  59.1 to make it 
clear that these regulatory requirements apply equally to subrecipients 
and to grantees, that grantees are responsible for requiring that their 
subrecipients (and the subrecipients of such subrecipients) agree to 
comply with such requirements, and that grantees are responsible for 
ensuring that their subrecipients so comply.
    Title X authorizes the Secretary to not only award grants but also 
enter into contracts to establish and operate voluntary family planning 
projects. 42 U.S.C. 300(a). Although contracts are used for Title X 
training, the Department is not aware of a history of establishing or 
operating Title X family planning projects by use of contracts instead 
of grants. Nevertheless, because the use of contracts to establish and 
operate family planning projects is explicitly authorized in the 
statute, the Department believes that the regulations should state that 
the substantive requirements for Title X family planning projects apply 
to projects whether they are established by grants or contracts. 
Therefore these rules propose to specify in Sec.  59.1 that, except for 
Sec. Sec.  59.3, 59.4, 59.8, and 59.10, the regulations of this subpart 
would also be applicable to the execution of contracts under Title X to 
assist in the establishment and operation of voluntary family planning 
projects. Applicable regulations would be applied in accordance with 
the statutes, procedures, and regulations that apply to the execution 
of a Federal contract, as distinct from a grant. Section 59.1 would 
specify that the use of the terms ``grant,'' ``award,'' ``grantee,'' 
and ``subrecipient'' in applicable regulations of this subpart would 
apply similarly to contracts, contractors and subcontractors, and the 
use of the term ``project'' or ``program'' would also apply to a 
project or program established by use of a contract. The Departments 
would specify that Sec. Sec.  59.3, 59.4, 59.8, and 59.10 would not 
apply to contracts, because those sections generally describe processes 
specifically applicable to grants and grant applications, as distinct 
from the substantive requirements of the other sections of this 
subpart. Because of the lack of a history of using contracts to 
establish or operate Title X projects, and because Title X funds used 
for a contract would offset funds used for a grant, the Department does 
not believe that specifying that these regulations also generally apply 
to Title X contracts would affect the regulatory or economic impact of 
these proposed rules. The Department invites comment on the 
applicability of these regulations to contracts for the provision of 
family planning services under Title X.

B. Section 59.2 Definitions

    The current Title X regulations include a limited number of 
definitions that are very general in scope including ``Act,'' 
``family,'' ``low-income family,'' ``nonprofit,'' ``Secretary,'' and 
``state.'' Important terms, such as ``family planning,'' ``grantee,'' 
and ``subrecipient,'' are not defined. The Department believes that, as 
a result of these omissions, the Title X regulations fail to provide 
sufficient clarity for prospective grantees and subrecipients, current 
grantees and subrecipients, and the general public. To ensure greater 
clarity and accountability in the use of Title X funds, the Secretary 
proposes the addition of four new definitions to the Title X 
regulations, 42 CFR 59.2:

 Family Planning
 Grantee
 Program or Project
 Subrecipient

    Under the proposed regulations, ``family planning'' would be 
defined 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. These means include 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 include preconceptional 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. Family planning and family planning 
services are never coercive and are strictly voluntary. Family planning 
does not include post-conception 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 Department believes that this proposed definition, which 
largely tracks the definition of ``family planning'' in the 1988 
Regulations, would provide greater clarity to grantees and 
subrecipients as to the type of activities that can be provided by 
projects funded under Title X. It is clear that Congress intended the 
term ``family planning'' to be broader in scope than simply 
contraception; natural family planning and infertility services are 
included as mandatory services explicitly enumerated in section 
1001(a). Physical examinations, breast and cervical cancer screenings, 
sexually transmitted disease (STD) and human immunodeficiency virus 
(HIV) testing, and pregnancy testing and counseling would continue to 
be authorized by this definition under the rubric of ``general 
reproductive and fertility health care.'' The proposed definition 
includes concepts from the 1988 rule identifying family planning as a 
process of establishing objectives for the number and spacing of 
children and the means of achieving those objectives. The proposed 
definition elaborates on ``objectives'' by specifying they involve both 
goals and plans, as inherent in the term family ``planning.'' The 
definition specifies that the process is ``voluntary,'' ``strictly 
voluntary,'' and ``never coercive,'' consistent with the statutory 
requirement that Title X apply only to ``voluntary'' family planning. 
The definition specifies that family planning includes management of 
infertility (including adoption). Both this definition and the 1988 
definition include general reproductive health care.\44\ The 1988 
definition elaborated that it included diagnosis and treatment of 
infections which threaten reproductive capability. This proposed 
definition would include that aspect of reproductive health care, as 
well as the goal of improving maternal and infant

[[Page 25514]]

outcomes and the health of those who seek family planning services.
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    \44\ The Department is aware that, in the international context, 
the term ``reproductive health care'' is often used to encompass 
abortion and related services. Given the long-standing prohibition 
on the use of Title X funds for programs/projects where abortion is 
a method of family planning and the focus of the Title X program on 
pre-conception care, the Department does not use the term in such a 
manner; in the Title X context, ``reproductive health'' or 
``reproductive health care'' does not encompass abortion or 
abortion-related services.
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    The other newly proposed definitions are designed to provide 
greater clarity concerning which entities are subject to the provisions 
of Title X.
    The Department proposes that ``project'' or ``program'' be defined 
as 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, 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. These proposed definitions are 
consistent with current Title X program practices.\45\
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    \45\ See, e.g., ``Definitions'' section of the ``Program 
Requirements for Title X Funded Family Planning Projects,'' Version 
1.0 (April 2014), https://www.hhs.gov/opa/sites/default/files/ogc-cleared-final-april.pdf.
---------------------------------------------------------------------------

    The Department proposes definitions of ``grantee'' and 
``subrecipient'' because confusion surrounds their meanings. In this 
proposed rule, ``grantee'' would mean the entity that receives Federal 
financial assistance through a grant and assumes legal and financial 
responsibility and accountability for the awarded funds and for the 
performance of the activities approved for funding and for making the 
required reports to OPA.
    A clear definition of ``subrecipient'' is necessary to ensure 
program integrity related to both financial and programmatic 
requirements. Title X service sites (i.e., clinics) that provide Title 
X services directly to individuals may receive Title X grant monies 
from the grantee (or another subrecipient) as a secondarily named 
provider or as an agency that provides services, but may not be 
specifically named within the grant application. There is a need for 
transparency that currently does not exist. The Department does not 
have an accurate understanding of any grantee's subrecipients, of what 
role each subrecipient plays in the overall function of the Title X 
project, or of the extent to which Title X funding supports the efforts 
of the subrecipient. Additional transparency would help to ensure 
accountability for, and wise use of, taxpayers' money. Current Title X 
regulations, however, do not require grantees to submit information to 
the government about their subrecipients, referral agencies, or other 
partners to whom Title X funds may flow. This lack of information is a 
barrier to OPA's oversight of the activities of its program and project 
subrecipients and, ultimately, to governmental accountability for those 
funds.
    Therefore, the Department proposes 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. This proposed definition would help clarify 
the entities that receive Title X monies, how they use these funds, and 
how their services comply with the purpose of the Title X program. In 
addition, the definition would elucidate the relationship between the 
grantees and their subrecipients, and would convey, along with the 
proposed changes to Sec.  59.1, that grantees are responsible for 
ensuring that their subrecipients (and the subrecipients of such 
subrecipients) comply with all statutory and regulatory requirements.
    To the extent an entity receives Title X funds from a grantee or a 
subrecipient, it receives funds to provide Title X services, and is 
thus a subrecipient subject to the Title X statute and regulations. By 
contrast, some referral agencies do not receive funds from the Title X 
grant program, but may nevertheless provide information, counseling, or 
services to a Title X client. A referral agency or individual is a 
person or entity which is a specialist in a certain field of service 
and to whom the Title X project refers patients for additional services 
not available at the Title X clinic site, or not adequately available 
at the site, to serve the immediate needs of the patient. For example, 
an individual may visit the Title X clinic for contraceptive services, 
but in the course of conversation, it may be revealed that the 
individual wants to end a current intimate and unhealthy relationship. 
In this case, a referral could then be made to an entity that has 
expertise in relationship counseling beyond what is available in this 
Title X clinic. In this and similar cases, the referral agencies would 
not be considered subrecipients, since they do not receive Title X 
funds. But because such services are an extension of the overall Title 
X service provision, in certain cases referral agencies participate in, 
and receive intrinsic non-monetary benefits as a result of, a formal or 
informal partnership with a Title X project. Accordingly, we seek 
comment on whether such a referral agency should be subject to the same 
reporting requirements as a grantee or subrecipient--by means of 
requiring grantees and subrecipients to use referral agencies only if 
they require the referral agencies to submit the required information. 
This could apply if the referral agency:
     Has a written agreement with the grantee or another 
subrecipient;
     specifically uses its inclusion in the Title X project to 
expand its influence in the community; or
     conducts its services, activities, or communications in 
such a way that its participation in the Title X project is central, or 
very important, to its existence.
    Finally, this proposed rule would amend 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 employers' religious beliefs or moral 
convictions. This would preserve conscience protections for entities 
and individuals whose health plans are subject to a mandate of 
contraceptive coverage through guidance issued pursuant to the Patient 
Protection and Affordable Care Act, while providing free or low-cost 
family planning services for such women at risk of unintended pregnancy 
or who otherwise desire comprehensive, holistic, family planning 
services.
    The proposed definition of ``low income family'' would maintain the 
ability of a Title X project to determine whether unemancipated minors 
who desire confidential services are low income based on their own 
resources. However, to ensure compliance with the statutory requirement 
that Title X projects encourage family participation in the decision of 
minors to seek family planning services, Title X clinics would be 
required to document in the minor's medical records the specific 
actions taken with respect to each minor to encourage such family 
participation. Documentation of such encouragement would not be 
required if the Title X clinic documents in the medical record that (1) 
the minor is suspected to be the victim of child abuse or incest and 
(2) it has, consistent with and if permitted or required by applicable 
State or local law, reported the situation to the relevant authorities.

C. Section 59.3 Who is eligible to apply for a family planning services 
grant or to participate as a subrecipient as part of a family planning 
project?

    Consistent with the requirements of the Joint Resolution of 
Disapproval,

[[Page 25515]]

signed by the President on April 13, 2017 (referenced above), the 
Department proposes to revise the heading and remove paragraph (b) of 
Sec.  59.3. Because of the joint resolution of disapproval, the 
Department is prohibited from reissuing the nullified 2016 Regulation 
in ``substantially the same form'' or issuing a ``new rule that is 
substantially the same'' as the nullified 2016 Regulation. 5 U.S.C. 
801(b). This proposed rule does not seek to re-issue the nullified 
provision at all, much less in substantially the same form, nor does 
the Department seek to issue, in this rulemaking, a new rule that is 
substantially the same as the nullified provision.

D. Section 59.5 What requirements must be met by a family planning 
project?

    Section 1001(a) of the Title X statute requires Title X projects to 
``offer a broad range of acceptable and effective family planning 
methods and services (including natural family planning methods . . 
.).'' The current regulations state, somewhat differently, that 
projects must ``[p]rovide a broad range of acceptable and effective 
medically approved family planning methods (including natural family 
planning methods) and services (including infertility services and 
services for adolescents),'' and note that ``[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.'' 42 CFR 59.5(a)(1).
    The current regulation, while worded differently than the statute, 
does not override the statutory requirement that projects offer ``a 
broad range of acceptable and effective family planning methods and 
services (including natural family planning methods . . .).'' 42 U.S.C. 
300(a). Although the current regulations require that projects provide, 
at a minimum, a broad range of ``medically approved'' family planning 
methods, they do not preclude the Department from requiring more, 
namely, as the statute provides, ``a broad range of acceptable and 
effective family planning methods and services (including natural 
family planning methods . . .).'' Moreover, the current regulations do 
not define ``medically approved,'' and have not required that a family 
planning method be regulated, approved, or certified by any particular 
agency or accreditation body. If a family planning method is, as 
required by the statute, ``acceptable and effective,'' it is likely to 
be approved by at least some medical sources. For example, 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.\46\ 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)).\47\ 
On this basis, fertility awareness-based methods of family planning 
could be said to be ``medically approved.'' Medical doctors and 
professional organizations can differ on which methods of health care 
they approve, including different methods of family planning. Such 
differences may be based on differing areas of expertise, or differing 
views of the health care method.
---------------------------------------------------------------------------

    \46\ See Women's Preventive Services Initiative, Clinical 
Recommendations, American College of Obstetricians and 
Gynecologists, https://www.womenspreventivehealth.org/recommendations/contraception.
    \47\ See HRSA, Women's Preventive Services Guidelines, https://www.hrsa.gov/womens-guidelines-2016/.
---------------------------------------------------------------------------

    Similarly, certain family planning methods or services may not fall 
under the regulatory jurisdiction or expertise of some government 
agencies. The Food and Drug Administration has regulatory jurisdiction 
over drugs, biologics, and medical devices. As such, while it has 
regulatory authority over and approves or clears contraceptive drugs 
and devices, FDA would not necessarily have regulatory jurisdiction 
over, or an approval process for, other family planning methods. Some 
fertility awareness-based methods of family planning might be a drug or 
device, such as certain fertility awareness kits that are or contain a 
medical device.\48\ Other fertility awareness-based methods of family 
planning might not be drugs or devices, use drugs or devices, or be 
sold in conjunction with drugs or devices. Some methods might be merely 
instructional, or might include the recommendation that certain kinds 
of drugs or devices be used, without the ``method'' itself being a drug 
or device. When HRSA added fertility awareness-based methods of family 
planning and counseling to its women's preventive services guidelines, 
it did so even though the guidelines already included all FDA-approved 
contraceptive and sterilization methods, because the birth control 
methods FDA has approved or cleared are all drugs and devices.\49\ The 
fact that non-drug and non-device fertility awareness-based methods of 
family planning are not on FDA's list of approved birth control methods 
does not mean that such fertility awareness-based methods are not 
``medically approved,'' but rather means that they are not drugs or 
medical devices, and, thus, not under FDA's jurisdiction and not 
subject to FDA's approval or clearance.
---------------------------------------------------------------------------

    \48\ See FDA Enforcement History, https://www.fda.gov/iceci/enforcementactions/enforcementstory/enforcementstoryarchive/ucm106947.htm (``Warning Letter Issued for ``Fertility Awareness 
Kit'').
    \49\ See FDA, https://www.fda.gov/ForConsumers/ByAudience/ForWomen/FreePublications/ucm313215.htm.
---------------------------------------------------------------------------

    The Department proposes to revert to the statutory language that 
Title X projects ``offer a broad range of acceptable and effective 
family planning methods and services.'' In so doing, the proposed rule 
would remove the language specifying that the family planning methods 
and services offered by a Title X project be ``medically approved.'' 
That language does not appear in the statute and may cause confusion 
about the type of family planning methods or services that a project 
may or should provide, and the type of approvals (if any) necessary 
before a Title X project can provide such method or service. The 
statutory language of ``acceptable and effective family methods or 
services'' provides better guidance for the types of methods and 
services that Congress sought to fund.
    The proposed rule would also make it more explicit that the 
requirement to provide a ``broad range'' of acceptable and effective 
family planning methods and services does not require a project to 
provide every acceptable and effective family planning method or 
service. The meaning of ``broad range'' has been the subject of 
inquiries from grantees and lawmakers at all levels of government, as 
well as from members of the public, and has resulted in potentially 
inconsistent interpretations of the ``broad range'' mandate. Some have 
interpreted the ``broad range'' requirement of section 1001(a), as well 
as of 42 CFR 59.5(a)(1), to require that a project provide all forms of 
family planning approved or cleared by the Food and Drug Administration 
(FDA). The plain language of the statutory (and regulatory) 
requirements, however, does not require projects to provide every 
acceptable and effective family planning

[[Page 25516]]

method or service (or, under the current regulation, acceptable and 
effective medically approved family planning methods and services), but 
rather a broad range of such methods and services.
    Not every grantee or subrecipient can provide--or should be 
required to provide--all services. The proposed rule would also make it 
more explicit that the requirement to provide a ``broad range'' of 
acceptable and effective family planning methods and services does not 
require a project to provide every acceptable and effective family 
planning method or service. This proposed change reflects the fact 
that, as the range of available family planning methods has 
significantly increased over the last few decades, it has become 
increasingly difficult and expensive for a Title X project to offer all 
acceptable and effective forms of family planning. Indeed, family 
planning projects are confronted with a variety of pharmacological, 
technological, or medical device options to consider in service 
delivery, with widely varying costs. Staffing limitations, 
technological capacity, economics (including costs and demand), and 
conscience concerns may be taken into account when grantees or 
subrecipients determine which methods they will offer within their 
scope of services. For example, natural family planning (NFP) services 
(and other fertility-awareness based methods) are a recognized form of 
family planning services under the statute, but many couples or 
families seeking these services may prefer specialized, single-method 
NFP service sites. Other sites serving men may offer only family 
planning methods relevant to that population. Another site may be a 
hospital satellite location which is primarily diagnostic in function, 
although it also offers some on-site family planning services. Such 
sites are permissible as components of a Title X family planning 
project, as long as the overall project provides a broad range of 
acceptable and effective family planning methods and services. In these 
examples, some participants in the Title X project offer specialized 
services, but not a broad range of family planning methods and 
services. However, such limited family planning service offering is 
permissible as long as the overall Title X project offers a broad range 
of family planning services, including contraceptives.\50\
---------------------------------------------------------------------------

    \50\ The Department notes that the Title X statute would not 
permit a Title X project to provide only one (or a limited number 
of) family planning methods and services.
---------------------------------------------------------------------------

    Thus, under the proposed rule, no Title X project would be required 
to provide every acceptable and effective family planning method or 
service, but all Title X projects would be required to provide a broad 
range of family planning methods. Family planning methods which are 
permitted with Title X funds include (but are not limited to): Male 
condom, spermicide, cervical cap, fertility awareness based methods, 
female condom, diaphragm, vaginal contraceptive ring, IUD, oral 
contraceptives, shot/injection, implantable rod, vasectomy, and sexual 
risk avoidance (or avoiding sex). Under the proposed rule, any 
organization that desires to provide only a single method, or limited 
number of methods of family planning, may participate, as long as the 
Title X project as a whole offers a broad range of family planning 
methods and services. Title X specifically identifies natural family 
planning, infertility services, and services for adolescents, as 
voluntary family planning services that Title X projects ``shall 
offer,'' 42 U.S.C. 300(a), making these family planning methods and 
services mandatory for each Title X project (although, as discussed 
elsewhere herein, it is not required that each provider within a 
project offer each method). That is, included in the broad range of 
acceptable and effective family planning methods and services that each 
Title X project must offer are natural family planning methods, 
infertility services, and services for adolescents.
    The proposed rule would also remove the requirement that past 
grantees be consulted for new services or projects in their locale as 
set forth in paragraph (a)(10)(i) of the current regulation. We believe 
that removing this requirement would encourage a broader range of 
applicants and permit innovative approaches that may not have been 
envisioned or supported by past grantees. While communication and 
coordination is often beneficial and encouraged, removing the 
requirement for consultation is intended to have the effect of 
loosening the status quo for service provision in a community in favor 
of a broader reach in order to previously underserved populations.
    The proposed rule would make it clear that, as contemplated by the 
statute, family planning is not limited to, or synonymous with, access 
to various methods of contraception, but includes a broader 
understanding of family planning methods and services. Family planning 
services should fit the family planning needs of the individual, and/or 
couple (if applicable). And in order to promote a holistic approach to 
family planning and reproductive health, the proposed rule would inform 
Title X service providers that they should offer either comprehensive 
primary health services onsite or have a robust referral linkage with 
primary health providers who are in physical proximity to the Title X 
site. This provision decreases the overall cost and transportation 
challenges related to access for vital health care services that may be 
discovered as a result of routine family planning screening and 
consultation. Title X service providers should ensure that they have a 
broad range of partners and diverse subrecipients in order to make it 
easier for all clients, particularly low income clients, to access 
necessary medical services and related educational and counseling 
services, as stipulated by the statute and as necessary to ensure that 
screening, diagnosis, and treatment can be provided within close 
proximity of the clinic, and to ensure that the most needy have access 
to care.\51\
---------------------------------------------------------------------------

    \51\ 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. The report also found 
that women who receive care at Title X clinics generally have worse 
health 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. Since 
Title X family planning services are generally limited to 
preconception services, it is important that Title X sites assist 
clients to achieve optimal preconception health. A large number of 
women experience unintended pregnancies, making the inclusion of 
preconception health screenings in the continuum of family planning 
care all the more important for all clients (male and female), not 
only those seeking pregnancy. Preconception health care is important 
because pregnancy may stress and affect extant health conditions; 
linkages to comprehensive primary health care may be critical to 
ensuring 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.
---------------------------------------------------------------------------

    To expand transparency surrounding Title X services, the proposed 
rule would require applicants to provide the following within their 
applications (to the extent secured at the time of application) and, if 
funded, in required reports, and in response to performance measures, 
wherever practicable:
     Names and locations of subrecipients, referral individuals 
and agencies, as well as services provided and to be provided by those 
entities;
     Detailed descriptions of all partnerships with such 
entities, including the extent of any

[[Page 25517]]

collaboration with subrecipients, referral individuals and agencies--as 
well as with less formal partners within the community--in order to 
demonstrate a seamless continuum of care for clients;
     A clear explanation of how the grantee will ensure 
adequate oversight and accountability for quality and effectiveness 
outcomes among subrecipients and those who serve as referrals for 
ancillary or core services.
    In addition, in order to promote compliance with a requirement 
present in both Title X itself and the Title X appropriations 
provisions,\52\ the proposed rule would require Title X service 
providers to encourage family participation in the decision of minors 
to seek family planning services and to document, in the records 
maintained with respect to each minor, the specific actions taken to 
encourage such family participation (or the specific reason why such 
family participation was not encouraged).\53\
---------------------------------------------------------------------------

    \52\ See 42 U.S.C. 300(a); Consolidated Appropriations Act, 
2018, Public Law 115-141, Div. H, sec. 207, 132 Stat. at 736.
    \53\ Of course, as noted above, the fact that child abuse, child 
molestation, incest, or the like is suspected and has been reported 
to the appropriate authorities, consistent with State or local 
reporting or notification laws, would constitute such reason.
---------------------------------------------------------------------------

E. Section 59.7 Criteria for Selection of Grantees

    As discussed above, the Department is focused on achieving better 
integration of primary and preventive care among a diverse group of 
applicants, using review criteria as a meaningful instrument to assess 
the quality of the applicant and the application. The current 
regulations give HHS flexibility in selecting grantees and determining 
awards, but could better ensure that review criteria are geared to 
achieving the selection of grantees that can best achieve the goals and 
purposes of the Title X program. Therefore, through the proposed rule, 
we would seek to achieve a two-fold goal:
     Update application review criteria to better achieve the 
statutory requirements and goals of Title X.
     Increase competition and rigor among applicants, 
encouraging broader and more diverse applicants, and better ensuring 
quality applicants will be selected.
    The Department desires to award grants for the establishment and 
operation of those Title X projects that would best promote the 
purposes of Title X and meet the statutory requirements imposed on 
Title X projects.
    We propose revising the current application review criteria at 
Sec.  59.7 through this rulemaking process to update and expand 
criteria for selection of Title X grantees as follows. Any grant 
applications that do not clearly address how the proposal will satisfy 
the requirements of this regulation would not proceed to the 
competitive review process, but would be deemed ineligible for funding. 
The Department would explicitly summarize each provision of the 
regulation (or include the entire regulation) within the Funding 
Announcement, and would require each applicant to describe their 
affirmative compliance with each provision. If the proposal is deemed 
compliant with the regulation, then applicants would 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,'' (PHS Act Sec. 1001(a), 42 
U.S.C. 300(a)), which meet all of the statutory and regulatory 
requirements and restrictions, and where ``none of the funds . . . 
shall be used in programs where abortion is a method of family 
planning.'' (PHS Act Sec. 1008, 42 U.S.C. 300a-6.)
    (2) The degree to which ``the relative need of the applicant'' (PHS 
Act Sec 1001(b), 42 U.S.C. 300(b)) is demonstrated in the proposal and 
the applicant shows capacity to ``make rapid and effective use'' (PHS 
Act Sec. 1001(b), 42 U.S.C. 300(b)) of grant funds, including and 
especially among a broad range of partners and diverse subrecipients 
and referral individual and organizations, and among non-traditional 
Title X partnering organizations.
    (3) The degree to which the applicant takes into account ``the 
number of patients to be served'' (PHS Act Sec. 1001(b), 42 U.S.C. 
300(b)), 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'' (PHS Act Sec.1001(b), 42 U.S.C. 300(b)) and the applicant 
proposes innovative ways to provide services to unserved or underserved 
patients.
    These proposed criteria would advance compliance with the text and 
purpose of Title X by seeking grantees to better serve the targeted 
population with services that are needed, focused on family planning in 
the context of holistic health in both the short and long term.
    The Department seeks public comment as to whether additional 
regulatory application review criteria may be necessary or advisable to 
reflect the text and purpose of the statutory provisions applicable to 
Title X, in particular section 1008; to protect the rights of 
individuals and entities who decline to participate in abortion-related 
activities; or to ensure that all services funded through Title X offer 
optimal health benefits to clients of all ages. The Department also 
seeks public comment as to whether the protections and services funded 
through Title X are adequately implemented and clearly understood 
throughout the Title X program, in order to alleviate the current 
confusion, and avoid future confusion, among clients and the general 
public.

F. Section 59.11 Confidentiality

    As discussed above, Title X grantees and subrecipients are required 
to comply with all State and local laws requiring notification or 
reporting of child abuse, child molestation, sexual abuse, rape, 
incest, and the like. Section 59.11 currently 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.'' To ensure that Title X grantees and 
subrecipients comply with applicable reporting requirements, the 
proposed rule would clarify that concerns about confidentiality of 
information may not be used as a rationale for noncompliance with such 
reporting laws.

G. Section 59.13 Standards of Compliance With Prohibition on Abortion

    Current Title X regulations at 42 CFR 59.5(a)(5) state that 
``[e]ach project supported under this part must . . . not provide 
abortion as a method of family planning.'' However, the Department has 
determined that such regulations do not provide sufficient guidance to 
ensure that Title X projects comply with section 1008 and do not 
encourage or promote abortion as a method of family planning. Proposed 
Sec.  59.13 would accordingly require that programs seeking Title X 
funding provide assurance satisfactory to the Secretary that, as Title 
X grantees, they do not provide abortions and do not include abortion 
as a method of family planning.

[[Page 25518]]

The proposed rule would also require assurance that grantees are in 
compliance with the prohibition on promoting abortion as a method of 
family planning; the maintenance of separation of the Title X project 
from prohibited activities; and the prohibition on activities that 
encourage, promote, or advocate for abortion. These specific 
requirements are designed to enable the Secretary to obtain, at the 
application stage, information relevant to determining whether a 
program or project will, in fact, comply with the statutory 
prohibition. Therefore, under the proposed rule, an applicant for Title 
X funds would be ineligible for those funds if it is unable to 
demonstrate to the satisfaction of the Secretary that it (and its 
subrecipients, if applicable) would comply with the regulations 
implementing section 1008.

H. Section 59.14 Prohibition on Referral for Abortion

    Proposed Sec.  59.14 would expressly prohibit Title X projects from 
performing, promoting, referring for, or supporting, abortion as a 
method of family planning.\54\ As discussed above, the Department 
believes that the current requirement under 42 CFR 59.5(a)(5)(ii) that 
a project provide abortion referrals to pregnant women upon request is 
inconsistent with section 1008, premised on an erroneous notion that 
the statute is neutral on the question whether Title X funds may be 
used to encourage or promote abortion as a method of family planning, 
and violative of Federal health care conscience statutes. The proposed 
provision would better implement section 1008 and better align the 
regulations implementing Title X with those Federal health care 
conscience statutes. It would also promote grantee diversity by 
expanding the number of qualified entities that would be willing and 
able to apply to provide Title X services, since potential grantees and 
subrecipients that refuse to provide abortion referrals may have been 
ineligible or discouraged from applying for Title X grants or seeking 
to provide family planning services under a Title X project by the 
requirements of the current regulations.
---------------------------------------------------------------------------

    \54\ In the case of rape and/or incest, it would not be 
considered a violation of the proposed 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 all 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.
---------------------------------------------------------------------------

    Proposed Sec.  59.14 would prohibit referral for abortion as a 
method of family planning or any other affirmative action to secure 
such an abortion in a Title X project. Under the proposed provision, 
referrals could not be used as an indirect means to encourage or 
promote abortion. In addition, Title X projects do not themselves 
provide post-conception care. Thus, proposed Sec.  59.14 would require 
that pregnant women be referred outside of the Title X project for 
prenatal care and other related medical and social services, as well as 
for other services relating to pregnancy after pregnancy is confirmed. 
In no case would the proposed provision permit a Title X-funded family 
planning program to make a referral for, or determine the 
appropriateness of, abortion as a method of family planning. As 
discussed above, a doctor, though not required to do so, would be 
permitted to provide nondirective counseling on abortion.\55\ Such 
nondirective counseling would not be considered encouragement, 
promotion, or advocacy of abortion as a method of family planning, as 
prohibited under section 59.16 of this proposed rule. Moreover, a 
doctor would also be permitted to provide a list of licensed, 
qualified, comprehensive health service providers, some (but not all) 
of which provide abortion in addition to comprehensive prenatal care. 
Providing such a list would be permitted only in cases where a program 
client who is currently pregnant clearly states that she has already 
decided to have an abortion.\56\ No participant in the Title X program 
may promote or support abortion as an acceptable mechanism of family 
planning through that Title X program. Thus, all other patients would 
be provided a list of licensed, qualified, comprehensive health service 
providers (including providers of prenatal care) who do not provide 
abortion as a part of their services, along with referrals for prenatal 
care and social services.
---------------------------------------------------------------------------

    \55\ That counseling on abortion be nondirective is required by 
the appropriations law applicable to Title X. See Consolidated 
Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, 132 
Stat. at 716-17 (``all pregnancy counseling shall be 
nondirective'').
    \56\ The list may not identify in any way the providers that 
perform abortions in addition to comprehensive prenatal care.
---------------------------------------------------------------------------

    It is important to recognize that proposed Sec.  59.14 would not 
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. Neither 
would proposed Sec.  59.5, or Sec.  59.14 preclude a health care 
professional from disclosing to a woman any physical findings the 
professional has made regarding the woman's condition; communicating an 
assessment of the urgency of the need for treatment; or ensuring that 
the woman is referred to the appropriate specialist for treatment of 
the condition, including emergent conditions, with adequate follow-up 
provided. Further, the proposed provision does not propose to alter the 
current requirement that Title X grantees and subrecipients provide for 
``necessary referral to other medical facilities when medically 
indicated,'' 42 CFR 59.5(b)(1); see also 42 CFR 59.5(b)(8); rather, to 
further emphasize this requirement, we are proposing to include 
consistent language in Sec.  59.14. Under this current provision of the 
Title X regulation, Title X projects must refer patients directly to a 
provider of emergency medical services (i.e., hospital emergency room), 
when such services are medically indicated. To ensure that such 
provisions are not abused in order to provide referral for abortion as 
a method of family planning, we propose conforming amendments to Sec.  
59.5(b)(1) and (8), which make such referrals subject to the 
requirements and prohibitions contained in proposed Sec.  59.14(a).
    Further, it is not the intent of the proposed regulatory provision 
at Sec.  59.14 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 
a condition that might make her extant pregnancy high risk. Nor would 
the provision preclude a health professional from disclosing to the 
woman any physical findings he or she has made regarding her condition 
and communicating his or her assessment of the urgency of her need for 
treatment or action, consistent with the exercise of his or her 
professional judgment, although the treatment or action might fall 
outside the parameters of the Title X program. Read together, proposed 
Sec.  59.14 and current Sec.  59.5(b)(1) would require that, if a woman 
who comes to a Title X-funded family planning program is confirmed to 
be pregnant, she must be referred externally for services related to 
her pregnancy. The program would be permitted to provide her with a 
listing of licensed health care providers of appropriate prenatal 
medical care and delivery services, from which she may choose. But 
Title X projects would not directly or indirectly encourage or promote 
abortion as a method of family planning through the manner in which 
referrals are made, or

[[Page 25519]]

the manner in which such list is constructed. As noted above, we 
propose conforming changes to Sec.  59.5(a)(5).

I. Section 59.15 Maintenance of Physical and Financial Separation

    Proposed Sec.  59.15 would create a requirement of both physical 
and financial separation between Title X services and any abortion 
services provided by the Title X grantee or subrecipient. As noted 
above, the current Title X program only requires financial (or 
bookkeeping) separation between Title X services and any abortion 
services provided by the Title X grantee or subrecipient. In accordance 
with section 1008, the Department wishes to ensure, among other things, 
that there is a clear separation between Title X services and any 
abortion services provided by a Title X grantee or subrecipients and 
that Title X funds are not being used to build infrastructure that 
supports, or may be used to support, the separate abortion business of 
a Title X grantee or subrecipient.
    Proposed Sec.  59.15 would require that Title X projects be 
physically and financially separate from programs in which abortion is 
provided or presented as a method of family planning, including 
programs that refer for abortions and programs that encourage, promote 
or advocate abortion as a method of family planning. It would describe 
relevant criteria that the Secretary proposes to use in determining 
whether a project has demonstrated sufficient separation from 
prohibited activities. Thus, proposed Sec.  59.15 would prohibit 
locating a Title X supported family planning program in a fashion which 
would not be physically and financially separate. This proposed 
standard would take into account the degree of separation of, among 
other things, waiting, consultation, examination, and treatment areas--
as well as telephone numbers, email addresses, any official 
communication devices, including social media, or websites. Thus, under 
the proposed provision, an impermissible use of Title X funds might 
occur when the physical facility of a grantee or subrecipient 
organization's Title X-funded family planning program shares space with 
any abortion-related operations.
    By requiring that Title X projects be physically and financially 
separate from abortion-related activities conducted by the grantee or 
subrecipient, proposed Sec.  59.15 would help facilitate compliance 
with Section 1008's prohibition on abortion as a method of family 
planning. It would also facilitate the Department's enforcement against 
grantees or subrecipients that do not comply with the statutory 
requirement that abortion not be a method of family planning in a Title 
X project. In particular, proposed Sec.  59.15 would allow the 
Department (and grantees) to make better case-by-case determinations 
about whether particular Title X projects or clinic locations have 
sufficient physical and financial separation from prohibited 
activities. To determine whether sufficient separation exists in a 
particular case, the Department would weigh all relevant factors, 
including:
     The existence of separate, accurate accounting records;
     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;
     The existence of separate personnel, electronic or paper-
based health care records, and workstations;
     The extent to which signs and other forms of 
identification of the Title X project are present, and signs and 
materials referencing or promoting abortion are absent.
    Because circumstances or site-specific factors are complex and 
organizational realities are varied, the Department would consider 
individual circumstances unique to a grantee or Title X provider. We 
intend to take a case-by-case approach in order to ensure program 
integrity, with sensitivity to individual projects and providers, and 
without imposing unnecessary requirements. We seek comment on whether 
additional factors should be considered, or whether any of the proposed 
factors should be omitted.
    The Department also seeks public comment as to whether additional 
regulatory provisions are necessary to reflect the text and purpose of 
section 1008. Even with a bright line rule of actual physical 
separation, confusion could still arise if the separate facilities--one 
facility providing Title X services and one providing abortion as a 
method of family planning--are operated under the same name. Similarly, 
the lack of a requirement of organizational separation could continue 
to blur the line between permitted and prohibited Title X services and 
activities, making enforcement more difficult. For example, individuals 
seeking Title X services may mistakenly visit non-Title X sites engaged 
in activities such as abortion which are actually prohibited by Title 
X, but that have the same names and are part of the same organization 
as the Title X site. The Department, therefore, seeks public comment as 
to whether additional regulatory provisions, such as a requirement for 
a Title X clinic to operate under a distinct name from a facility that 
provides abortion as a method of family planning, or for organizational 
separation, are necessary to ensure compliance with section 1008.

J. Section 59.16 Prohibition on Activities That Encourage, Promote or 
Advocate for Abortion

    Consistent with the statutory provisions discussed above, and the 
prohibition in section 1008 on the use of Title X funds in programs 
where abortion is a method of family planning, proposed Sec.  59.16 
sets out a number of restrictions designed to ensure that Title X 
grantees and subrecipients do not promote or encourage abortion as a 
method of family planning using Title X funds. The proposed rule would 
prohibit the following actions when undertaken with Title X funds: 
Lobbying, providing speakers that promote abortion in the project or by 
the use of project funds, attending events or conferences during which 
such lobbying takes place, paying dues to organizations that advocate 
for the availability of abortion services, taking legal action to make 
abortion available as a method of family planning, and developing or 
disseminating materials advocating abortion as a method of family 
planning or otherwise promoting a favorable attitude toward abortion. 
Thus, consistent with proposed Sec.  59.15, any grantee or subrecipient 
engaging in these activities with non-Title X funds, would be required 
to give evidence that such use of funds is physically and financially 
separate from the use of Title X funds.

K. Section 59.17 Compliance With Reporting Requirements

    New provision Sec.  59.17 would address explicitly 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. The Consolidated 
Appropriations Act, 2018 included the following provision: 
``Notwithstanding any other provision of law, no provider of services 
under Title X of the Public Health Service Act shall be exempt from any 
State law requiring notification or the reporting of child abuse, child 
molestation, sexual abuse, rape, or incest.'' See Consolidated

[[Page 25520]]

Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 208, 132 
Stat. 348, 736 (2018); Consolidated Appropriations Act, 2017, Public 
Law 115-31, Div. H, sec. 208, 131 Stat. 135, 539 (2017); Consolidated 
Appropriations Act, 2016, Public Law 114-113, Div. H, sec, 208, 129 
Stat 2242, 2620 (2015). This provision is consistent with language that 
has been included in appropriations acts for HHS since fiscal year 
1999. 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). The Department interprets this statutory notification/
reporting requirement as encompassing not only any State or local law 
requiring reporting or notification dealing with child abuse, child 
molestation, sexual abuse, rape, or incest, but also those State or 
local laws respecting intimate partner violence and human trafficking 
because such criminal activities would be encompassed within the 
categories of crime enumerated in the Appropriations Act (``child 
abuse, child molestation, sexual abuse, rape, or incest''). In 
addition, the Department interprets this reporting/notification 
requirement as applicable to all victims of such crimes, regardless of 
age, because the victims of sexual abuse, rape, or incest can be any 
age. Current Title X regulations permit the use of confidential 
information obtained by project staff to comply with State and local 
reporting requirements,\57\ but do not expressly address the 
requirement to report child abuse, child molestation, sexual abuse, 
rape, incest, intimate partner violence, human trafficking, or other 
sexual exploitation, nor affirmatively impose an obligation on Title X 
grantees and subrecipients to comply with State reporting or 
notification requirements.
---------------------------------------------------------------------------

    \57\ See 42 CFR 59.11.
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    Title X grantees and subrecipients have an affirmative obligation 
to comply with notification or reporting requirements; merely being 
aware of such requirements is insufficient to comply with the law. 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 (1997).

    Some practitioners have proposed that providers avoid soliciting or 
determining the age of the adolescent or the age of their sexual 
partner as a means of assuring the adolescent of confidential services 
and, thus, avoiding the potential responsibility of reporting. But 
Title X exempts neither Title X clinics nor Title X healthcare 
providers from their responsibility to comply with State and local 
reporting laws. Sexual exploitation, abuse, or assault (including 
statutory rape) are crimes that affect individuals, families, and 
communities. Title X projects should lead the Nation in 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; \58\ and in assuring appropriate support and management of 
teens (and women) who have been exploited, abused or coerced into 
unequal sexual partnerships.
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    \58\ As noted above, 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 Consolidated Appropriations Act, 2018, 
Public Law 115-141, Div. H, sec. 207, 132 Stat. 348, 736 (2018); 
Consolidated Appropriations Act, 2017, Public Law 115-31, Div. H, 
sec. 207, 131 Stat. 135, 538 (2017); Consolidated Appropriations 
Act, 2016, Public Law 114-113, Div. H, sec. 207, 129 Stat 2242, 2620 
(2015).
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    The Department believes that existing efforts to ensure compliance 
with State and local reporting laws protecting minors and other 
vulnerable populations should be strengthened. While a 2005 report from 
the Department's Office of Inspector General (OIG) revealed that 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.\59\ Through the 
proposed rule, the Department would require, as a condition of 
receiving Title X funding, that a project provide assurance that it has 
a plan in place to comply with State and local laws requiring 
notification or reporting and maintains appropriate documentation of 
compliance with these reporting requirements.
---------------------------------------------------------------------------

    \59\ HHS OIG, Letter on Federal Efforts to Address Applicable 
Child Abuse and Sexual Abuse Reporting Requirements for Title X 
Grantees (OEI-02-03-00530) (April 25, 2005), https://www.hhs.gov/opa/sites/default/files/child-abuse-reporting-requirements.pdf.
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    Proposed Sec.  59.17 would clarify the affirmative 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. It would require that Title X grantees and subrecipients 
have in place a plan that demonstrates 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. As part of prevention, protection, and risk 
assessment efforts, grantees and subrecipients should include in such 
plan 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. In 
addition, Title X projects would be 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 
would be 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 also treat 
STDs.
    Additionally, proposed Sec.  59.17 would require 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 law, and what reports or notifications 
were made to appropriate State agencies. The Department would use this 
documentation to ensure appropriate compliance with State and local 
reporting requirements.

L. Section 59.18 Appropriate Use of Funds

    Consistent with section 1008, proposed Sec.  59.18 would prohibit 
the use of Title X funds to build infrastructure of a Title X grantee 
or subrecipient for purposes outside of those permitted under the Title 
X regulations and authorized within section 1001 of the Public Health 
Service Act and not barred by section 1008--that is, to offer family 
planning methods and services, which do not include abortion as a 
method of family planning. It would clarify that grantees should use 
the majority of grant funds to provide direct services to clients and 
give a detailed accounting for usage related to grant dollars, both in 
applications for funding and in any annually required reporting. Under 
proposed Sec.  59.18, any change in the usage of grant funds within the 
grant cycle would require the approval of the Department. In addition, 
Sec.  59.18 would require each project to fully account for,

[[Page 25521]]

and justify, charges against the Title X grant.
    As detailed previously, the current flexibility in the usage of 
Title X funds permits an interchangeability of assets that grantees may 
have used to build infrastructure for non-Title X purposes, including 
abortion services. This danger is exacerbated because Title X providers 
must secure other sources of revenue to leverage Title X grants. See 42 
CFR 59.7(c). Infrastructure building may include physical space, health 
information technology systems, including electronic health records, 
bulk purchasing of contraceptive and other clinic supplies, clinical 
training for staff, and community outreach and recruitment. Title X is 
the only discrete, domestic, Federal grant program solely focused on 
the provision of cost-effective family planning services, and 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 become only more important. The Department 
accordingly proposes (1) to prohibit use of Title X funds for 
infrastructure building for purposes outside of the Title X program, 
(2) to require a detailed accounting for usage related to grant 
dollars, and (3) to prohibit any change in the use of grant funds 
without the approval of the Department. In this way, the proposed 
section would ensure that Title X funds are used for the purposes 
expressly mandated by Congress--that is, to offer family planning 
methods and services.

M. Section 59.19 Transition Provisions

    The Department proposes two different periods of transition to 
these requirements. Most of the proposed changes to the Title X 
regulations are merely clarifications of existing statutory 
requirements or impose requirements that would not seem to require a 
lengthy period of time for compliance. The Department recognizes, 
however, that it might take a longer period of time for grantees and 
subrecipients to comply with the proposed requirement to establish and 
maintain physical separation of the Title X project from the provision 
of abortion. Accordingly, the following compliance dates are proposed 
to provide a transition period:
     Section 59.15: Requirement for physical separation: One 
year after the date of publication of the final rule.
     All other proposed requirements, including the requirement 
for financial separation: 60 Days following publication of the final 
rule.

V. Regulatory Impact Statement

A. Introduction and Summary

    We have examined the impacts of this proposed 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 (RFA), 
section 1102(b) of the Social Security Act, section 202 of the Unfunded 
Mandates Reform Act of 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, Executive Order 13771 on Reducing 
Regulation and Controlling Regulatory Costs (January 30, 2017), and the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
1. Executive Orders 12866 and 13563 and the Congressional Review Act
    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). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting 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) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order. A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year). We estimate 
that this rulemaking is not ``economically significant'' as measured by 
the $100 million threshold. We have prepared a regulatory impact 
analysis that, to the best of our ability, presents the costs and 
benefits of the rulemaking and are including it here in order to 
provide further evidence of the value of this proposed rule. This 
proposed rule has been submitted to the Office of Management and Budget 
for review.
2. Regulatory Flexibility Act (RFA)
    The RFA requires agencies that issue a regulation to analyze 
options for regulatory relief of small entities, businesses, and 
501(c)(3) and 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.'') HHS considers a rule to have a significant economic impact 
on a substantial number of small entities if at least 5 percent of 
small entities experience an impact of more than 3 percent of revenue. 
HHS proposed to certify that the proposed rule would not 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.'' The current threshold after adjustment 
for inflation is $150 million. HHS does not expect this proposed rule 
to result in expenditures that would exceed this amount.
4. Executive Order 13132
    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. HHS has determined that the proposed rule, if 
finalized, would not contain policies that would 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 proposed 
changes in the rule represent the

[[Page 25522]]

Federal Government regulating its own program. Accordingly, HHS 
concludes that the proposed 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 Proposed Rule
    This rule proposes to amend the regulations governing the Title X 
program to ensure programmatic compliance and integrity. Specifically, 
the proposed 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.
    (4) We evaluate the effects of this rule over 2019-2023. Costs are 
estimated to be $45.5 million in 2019 and $14.6 million in subsequent 
years. Present value costs of $88.6 million and annualized costs of 
$21.1 million are estimated using a 3 percent discount rate; present 
value costs of $72.4 million and annualized costs of $21.6 million are 
estimated using a 7 percent 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 discount rate
                                                                 (millions of 2016 dollars)
                                                       Annualized value over 5 years by discount rate
                                                                 (millions of 2016 dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
BENEFITS                                                            3 Percent                7 Percent                3 Percent                7 Percent
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 removal of abortion counseling and referral requirements that potentially violate federal health care conscience
 protections. Enhanced patient service and care.
--------------------------------------------------------------------------------------------------------------------------------------------------------
COSTS                                                               3 Percent                7 Percent                3 Percent                7 Percent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quantified Costs                                                         88.6                     72.4                     21.1                     21.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-quantified Costs....................................................................................................................................
None....................................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We invite comment on all aspects of this regulatory impact 
analysis, including the assumptions and conclusions contained in the 
analysis.

B. Analysis of Economic Impacts

1. Need for the Proposed Rule
    This proposed rule seeks to address two categories of problems:
    (1) Insufficient compliance with the statutory program integrity 
requirements and 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 discussed supra in Part 
II (Need for Change) fall into one or more of these categories.
    While the current 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 not 
used to encourage or promote abortion in any way. For example, the 
current 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 build 
infrastructure for abortion services, including physical space, health 
information technology systems, including electronic health records, 
bulk purchasing of contraceptives and other clinic supplies, clinical 
training for staff, and community recruitment.
    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 funded services and abortion-
related services for which Title X funds cannot be used.
    The current regulations suffer from additional deficiencies. They 
are inconsistent with the conscience 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 expressly address the obligation of Title X grantees and 
subrecipients to comply with State 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

[[Page 25523]]

support or oppose any candidate for public office. In addition, the 
current regulations do not require Title X providers to 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 current regulations fail to 
require grantees to provide the Department sufficient information about 
the subrecipients with which they (or their subrecipients) contract and 
any referral agencies or other partners to whom Title X funds may flow, 
thus precluding OPA from exercising appropriate oversight of the 
activities of its program and project subrecipients.
    This proposed rule addresses each of the foregoing problems. First, 
to assist the Department in ensuring compliance with, and enforcement 
of, the section 1008 prohibition, the proposed rule would prohibit 
family planning projects from using Title X funds to provide or present 
abortion as a method of family planning; require assurances of 
compliance; eliminate the requirement that Title X projects provide 
abortion counseling and referral; prohibit Title X projects from 
performing, promoting, referring for, or supporting, abortion as a 
method of family planning; require physical and financial separation of 
Title X activities from those which are prohibited under section 1008; 
prohibit certain activities that encourage, promote, or advocate for 
abortion; 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 proposed rule would reiterate the voluntary, non-
coercive nature of Title X services; require Title X facilities to 
encourage family participation in a minor's decision to seek family 
planning services; explicitly prohibit 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; incorporate the 
encouragement of family participation into the regulations; clarify the 
affirmative duty of projects to comply with State and local laws 
requiring notification and reporting of criminal sexual exploitation; 
clarify that confidentiality of information may not be used as a 
rationale for noncompliance with such notification or reporting laws; 
and require assurances of compliance and maintenance of records.
    To assist the Department in ensuring compliance with, and 
enforcement of, conscience protections embodied in the Church, Coats-
Snowe, and Weldon Amendments, the proposed rule would eliminate the 
requirement that Title X projects provide abortion counseling and 
referral; prohibit Title X projects from performing, promoting, 
referring for, or supporting, abortion as a method of family planning; 
and clarify that single-method service sites are permissible as 
components of a Title X family planning project, as long as the overall 
project provides a broad range of acceptable and effective family 
planning methods and services.
    The Department believes that these proposed changes would ensure 
fidelity to the statutory requirements and purposes of the Title X 
program, the appropriations provisos and riders addressing the Title X 
program, and obligations and requirements established under other 
Federal law. They would do so by aligning the current regulations with 
these statutory provisions and providing the Department with the 
oversight tools necessary to ensure compliance.
    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 
proposed rule would clarify the definition of family planning; require 
the referral of pregnant patients for appropriate prenatal and/or 
social services; require the provision of comprehensive primary health 
services onsite or through a robust referral linkage; and update the 
application review criteria.
    The Department expects that these proposed changes would ensure 
that the Title X program takes a holistic approach to family planning 
through the inclusion of referral to prenatal care and social services 
for pregnant clients and requiring either comprehensive primary health 
services onsite or through a robust referral linkage.
    Third, to improve transparency regarding the provision of services, 
the proposed rule would require additional information from applicants 
and grantees regarding subrecipients, referral agencies, and community 
partners; require a clear explanation of how grantees would ensure 
adequate oversight and accountability for compliance and quality 
outcomes among subrecipients and those who serve as referrals for 
ancillary or core services; and require each project supported under 
Title X to fully account for, and justify, charges against the Title X 
grant. The Department anticipates that these proposed changes will 
provide the information necessary to ensure, and determine compliance 
with the statutory provisions on, program integrity, and the legal and 
ethical usage of taxpayer dollars.
    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 would have 
the authority to initiate compliance reviews and take appropriate 
action to assure compliance with the provisions in this proposed rule.
2. Affected Entities
    This proposed rule would affect the operations of entities who may 
receive Title X grants or be subrecpients 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. These entities operated at 3,898 service sites, and provided 
services to 4,007,552 people. For purposes of this analysis, we assume 
that these numbers will remain the same across time. Title X services 
were delivered by 3,550 clinical services provider 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). 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. 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. 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. To estimate the number of FTEs in these categories, we 
assume that there are 1,403 encounters per FTE for individuals in these 
categories, which implies approximately 1,219 FTEs in this category in 
2016. To convert FTEs reported in Family Planning Annual Report (FPAR) 
to the number of individuals in these categories, we assume that each 
individual works an average of between 0.5 FTEs and 1.0 FTEs delivering 
Title X services, with 0.75 FTEs as our central estimate, uniformly 
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-funded family planning 
services. We use these estimates as our

[[Page 25524]]

estimate of service providers affected by this rule.
    We estimate 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 \60\ and salaries from the U.S. Office 
of Personal Management.\61\ We use 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, we use the average wage across this group when discussing 
impacts affecting the group. We use 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 recipients, we take the average 
wage across all occupations in the U.S. We assume that the 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. We divide annual 
salaries by 2,087 hours to derive hourly wages. We assume that the 
total dollar value of labor, which includes wages, benefits, and 
overhead, is equal to 200 percent of the wage rate. Estimated hourly 
rates for all relevant categories are included below.
---------------------------------------------------------------------------

    \60\ Bureau of Labor Statistics, Occupational Employment and 
Wage Statistics (May 2016), https://www.bls.gov/oes/2016/may/oes_nat.htm.
    \61\ 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, we estimate impacts over five years starting in 
2019.

                          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
    In order to comply with the regulatory changes proposed in this 
proposed rule, affected entities would first need to 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, we 
estimate that potential grantees and subrecipients range between 100% 
and 300% of their 2016 values, with a central estimate of 200%. This 
implies 182 potential grantees and 2,234 potential subrecipients. We 
estimate that learning the 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 a final rule in this rulemaking.
b. Training
    Individuals involved with delivering family planning services would 
also need to receive training on the requirements of the proposed rule. 
To convert FTEs reported in FPAR to the number of individuals that 
would receive training, we assume that each individual works an average 
of between 0.5 FTEs and 1.0 FTEs delivering Title X services, with 0.75 
FTEs as our central estimate. This implies that there are approximately 
4,733 clinical service providers and 1,625 other service providers who 
would need training in order to ensure compliance with these 
regulations when finalized. We estimate that these individuals would 
require an average of 4 hours of training in the first year following 
publication of this rule. In subsequent years, we assume 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. We estimate 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. 
We estimate that this would require half of an FTE at the GS-13 level 
and half of an FTE at the GS-14 level. We estimate that all of these 
costs would be incurred in the first year following publication of the 
final rule. As a result, using wage information provided in Table 2, 
this would imply costs of $0.43 million in the first year following 
publication of a final rule in this rulemaking.
c. Assurance Submissions
    Title X grantees and subrecipients would face new assurance 
requirements because of this proposed rule. We estimate that these new 
requirements would require a lawyer to spend an average of 3 hours 
reviewing the assurances, 3 hours reviewing organizational policies and 
procedures, or to take other actions to assess compliance, and a 
medical and health services manager to spend 2 hours total for the same 
tasks the first year following publication of the final rule at each 
grantee and subrecipient. In subsequent years, we estimate 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 to take 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. As a result, using wage 
information provided in Table 2, this would imply costs of $1.2 million 
in the first year and $0.9 million in subsequent years following 
publication of a final rule in this rulemaking.
d. Documentation of Compliance
    Title X grantees and subrecipients would need to document their 
compliance with new requirements because of this proposed 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. We estimate that each occurence would require a physician 
assistant to spend an average of 2 minutes to make appropriate 
documentation in a minor's medical

[[Page 25525]]

records. Approximately 20% (800,000) of the 4 million Title X clients 
are adolescents. We estimate that complying with the requirement to 
encourage family participation will result in 75% (600,000) of 
adolescent patients' medical records requiring appropriate 
documentation. As a result, using wage information provided in Table 2, 
this would imply costs of $2.0 million in the each year following 
publication of a final rule in this rulemaking.
    Second, grantees must generate reports with information related to 
subrecipients, referral agencies and individuals involved in the 
grantee's Title X project. We estimate 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. As a result, using wage information provided in Table 
2, this would imply costs of $0.3 million in each years following 
publication of a final rule in this rulemaking.
e. Monitoring and Enforcement
    This proposed rule would result in additional monitoring of Title X 
grantees and subrecipients in order to ensure compliance with new 
regulatory and existing statutory requirements. We estimate 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 
spent by Federal staff. We estimate 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 a 
final rule in this rulemaking.
f. Physical Separation
    As a result of this proposed rule, Title X providers would be 
required to provide Title X services at facilities that physically 
separate from locations at which abortion as a method of family 
planning is provided. A Congressional Research Service \62\ report 
estimates that 10% of clinics that receive Title X funding offer 
abortion as a method of family planning separately from 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, we estimate 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. We estimate that this evaluation 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 a 
final rule. Similarly, we estimate that this evaluation would affect 
between 10% and 30% of grantees, with a central estimate of 20%. We 
estimate that this would require an average of an additional forty 
hours, divided evenly between lawyers and management staff, at each 
affected grantee, in the first year following publication of a final 
rule. We estimate 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, we estimate that an average of between $10,000 and $30,000, with 
a central estimate of $20,000, would be incurred to come into 
compliance with physical separation requirements in the first year 
following publication of a final rule in this rulemaking. As a result, 
using wage information provided in Table 2, this would imply costs of 
$24.38 million in the first year following publication of a final rule.
---------------------------------------------------------------------------

    \62\ Napili, A., Title X (Public Health Service Act) Family 
Planning Program, Congressional Research Service Report RL33644 
(Aug. 31, 2017).
---------------------------------------------------------------------------

g. Encouraging Parental Involvement in Family Planning Services
    Title X providers are already required by the statute to encourage 
minors to involve their parents in family planning services. However, 
it is currently unclear whether this requirement is being satisfied by 
Title X providers. As a result, this proposed rule would require that 
actions be taken to satisfy this requirement and that such actions be 
documented in a minor's medical record. We believe that this will 
result in improved compliance with the statutory requirement that 
minors be encouraged to involve their parents in family planning 
services. As noted previously, we estimate that complying with the 
requirement to document the encouragement of family participation will 
result in 600,000 adolescent patients' medical records requiring 
documentation as a result of these requirements each year. We estimate 
that an additional 0-50% of these adolescents, with a central estimate 
of 25%, would receive additional encouragement to involve parents as a 
result of a final rule in this rulemaking proceeding each year. We 
estimate 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 in each year 
following publication of a final rule in this rulemaking. As a result, 
using wage information provided in Table 2, this would imply costs of 
$2.93 million in each year following publication of a final rule.
4. Estimated Benefits
    This proposed 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 proposed 
rule, we also expect the quality of service to improve. Finally, the 
proposed 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 in the preamble, 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, and has 
been reiterated through annual appropriations provisos. This proposed 
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 would 
ensure greater accountability for the use of Federal funds, mitigate 
confusion about what services the Federal government supports and 
funds, and increase the amount of Title X funds

[[Page 25526]]

that are used to deliver family planning services.
b. Patient/Provider Benefits and Protections
    The Department expects that the proposed rule would have additional 
benefits for patients and providers. Benefits for patients are at least 
twofold. First, as noted above, the new regulation would require 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 
would promote seamless care and services for patients while expanding 
the breadth of services available within the states, territories and 
throughout the regions.
    Second, the proposed regulation would protect certain patients from 
further victimization. It would do so by requiring Title X grantees and 
subgrantees 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 
and children.
    For providers, the proposed regulation is expected to create 
benefits through respect for conscience. It would 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 and referrals. Potential grantees, and 
subrecipients that refuse to provide abortion counseling and referrals 
may now be eligible and interested in applying to provide family 
planning services under the current Title X regulations. 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 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.'' \63\ Facilitating open 
communication between providers and their patients helps to eliminate 
barriers to care, particularly for minorities. 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.'' \64\ 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 or moral 
convictions feel they are being treated fairly and that their religious 
or moral convictions are respected.\65\
---------------------------------------------------------------------------

    \63\ 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.
    \64\ 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.
    \65\ Id.
---------------------------------------------------------------------------

C. Analysis of Regulatory Alternatives

    The Department carefully considered the alternatives to this 
proposed rule, but concluded that none 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 law; 
and (2) lack of transparency regarding the provision of services.
    First, the Department considered maintaining the status quo and 
utilizing programmatic guidance and funding opportunity announcements 
(FOAs, also known as notices of funding opportunities) to address the 
problems described above. Such actions, however, would be incompatible 
with part 59 as it currently exists. Specifically, Title X providers 
would still be required to provide counseling on, and referral for, 
abortion upon request, a requirement inconsistent with section 1008 
that could be discouraging to, and disqualify, potential grantees and 
subrecipients that refuse to counsel on, or provide referrals for, 
abortion. The maintenance of this requirement, as noted above, 
potentially violates the Coats-Snowe Amendment and the Weldon 
Amendment. Moreover, there would be 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 using 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 in the 
preamble, application review criteria must serve as a meaningful 
instrument to assess the quality of the applicant and the application. 
The current application review criteria 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. While the 
Department has discretion under the current criteria to issue FOAs that 
add to criteria in the regulation, as past FOAs have done, and the 
Department could thus seek to strengthen the selection criteria through 
FOA requirements, such an approach is inadequate to ensure that 
appropriate criteria are fully set forth, required by regulation, and 
give the public notice of the long term commitment of the program.
    HHS 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, we considered:
    (1) Maintaining the status quo, where only line-item financial 
separation from activities that treat abortion as a method of family 
planning is required. Currently Title X costs must be pro-rated from 
abortion-related activities. There is a need for greater financial 
oversight and accountability than is possible under the current 
regulations, in order to ensure that Title X funds are used only for 
permissible Title X services. And the current financial accounting 
separation leaves too much ambiguity surrounding abortion activities 
that may be a part of the overall services of the organization

[[Page 25527]]

or facility, although not a part of Title X-funded family planning 
services.
    (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 to some extent, the current 
confusion between Title X and abortion-related services. The Department 
determined that this less restrictive option might serve the same goal 
in erasing 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 it would be likely that the 
segregation of staff/staff responsibilities within the same reception 
area 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 partially mitigate, 
but not eliminate, the public perception and confusion. Different 
examination rooms would likely have little impact because patients 
would likely 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.
    Thus, for these reasons and the reasons for our decision to propose 
both physical and financial separation, we preliminary determine that 
both of these options would be insufficient to ensure statutory 
compliance and clarity regarding such compliance. The Department seeks 
public comment on these alternatives.
    The Department seeks comment on whether additional policies or 
requirements, beyond those proposed herein, should be imposed to ensure 
compliance. These include expanding the requirement that referral 
agencies that do not receive Title X funds but nevertheless provide 
information, counseling, or services to Title X clients be subject to 
the same reporting and compliance requirements as do grantees and 
subrecipients; and requiring organizational separation in addition to 
physical and financial separation.
    The Department invites comment on both its proposed approach and 
other approaches to assure compliance with the statutory requirements, 
along with the provision of holistic family planning services, age 
appropriate education and services for adolescents, and other services 
that promote healthy outcomes and provide transparency regarding the 
provision of services.

D. Executive Order 13771

    Executive Order 13771 (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 proposed rule, if finalized as 
proposed, is expected to be an Executive Order 13771 regulatory action. 
The Department estimates that this rule generates $13.6 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 proposed rule has a significant impact on a substantial number of 
small entities. HHS considers a rule to have a significant economic 
impact on a substantial number of small entities if at least 5 percent 
of small entities experience an impact of more than 3 percent of 
revenue.
    We calculate the costs of the proposed changes per service site 
over 2019-2023. The estimated average annualized cost of the rule per 
service site is approximately $5,423 using a 3 percent discount rate. 
We note 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 proposed 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 the proposed rule would 
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 
proposed policy or regulation could affect family well-being.\66\
---------------------------------------------------------------------------

    \66\ 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 proposed 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.\67\ If the 
determination is affirmative, then the Department or agency must 
prepare an impact assessment to address criteria specified in the law.
---------------------------------------------------------------------------

    \67\ Treasury and General Government Appropriations Act, 1999, 
Public Law 105-277, sec. 654, 112 Stat. 2681, 2681-528-2681-530 
(1998).
---------------------------------------------------------------------------

    The Department believes the action taken in this proposed 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.
    The Secretary proposes to certify that this proposed 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 would not negatively affect family well-
being.

G. Paperwork Reduction Act

    This proposed 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. 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) 
requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.

[[Page 25528]]

     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.
    We are soliciting public comment on each of the required issues 
under section 3506(c)(2)(A) of the PRA. The collections of information 
required by the proposed 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).
    Proposed Sec.  [thinsp]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 
proposed 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.
    Proposed Sec.  [thinsp]59.5 would require 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 would 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).
    Proposed Sec.  [thinsp]59.7 would require Title X grant applicants 
to describe, within their applications, their affirmative compliance 
with each provision of the regulations governing the Title X program.
    Proposed Sec.  59.13 would require 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 would 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. Sec.  59.14 through 59.16.
    Proposed Sec.  59.17 would require 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 would also require Title X 
grantees to maintain records to demonstrate compliance with the 
requirements of Sec.  59.17, and make continuation of funding for Title 
X services contingent upon demonstrating to the Secretary that the 
criteria have been met.
    Lastly, proposed Sec.  59.18 would require 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 recipients to sign. We anticipate 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 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. We estimate 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). We estimate 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 recipients 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. We assume 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. We estimate 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, and referral agencies 
and 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).

[[Page 25529]]



 Table 3--Proposed Annual Recordkeeping and Reporting Requirements or Burden of Response in Year One/Subsequent Years Following Publication of the Final
                                                                          Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                               Burden per
           Regulation burden               OMB control       Respondents       Hourly rate      response        Total annual     Labor cost of reporting
                                               No.            responses            ($)           (hours)       burden (hours)              ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Assurance of Compliance................  ..............         1,208/1,208     63.58/62.36             8/6         9,664/7,248          614,000/452,000
Documentation of Compliance............  ..............         1,208/1,208     52.58/52.58             2/2         2,416/2,416          254,000/254,000
Documentation on Minor's Medical         ..............     600,000/600,000     49.08/49.08         .03/.03     100,000/100,000          982,000/982,000
 Records...............................
                                                        ------------------------------------------------------------------------------------------------
    Total Cost.........................  ..............  ..................  ..............  ..............  ..................      5,813,000/5,424,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The Department asks for public comment on the proposed information 
collection including what additional benefits may be cited as a result 
of this proposed rule.
    Comments regarding the collection of information proposed in this 
proposed rule must refer to the proposed rule by name and docket 
number, and must be submitted to both OMB and the Docket Management 
Facility where indicated under ADDRESSES by the date specified under 
DATES.
    When it issues a final rule, the Department plans to publish in the 
Federal Register the control numbers assigned by the Office of 
Management and Budget (OMB). Publication of the control numbers 
notifies the public that OMB has approved the final rule's information 
collection requirements under the Paperwork Reduction Act of 1995.

List of Subjects in 42 CFR Part 59

    Abortion, Birth control, Family planning, Grant programs.

    For the reasons set forth in the preamble, the Department of Health 
and Human Services proposes to amend 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, grantees shall require 
subrecipients (and the subrecipients of subrecipients) to comply with 
the requirements contained in such regulations pursuant to their 
written contracts with such subrecipients, and shall be required to 
ensure that their subrecipients (and the subrecipients of 
subrecipients) comply with such requirements.
    (b) Except for Sec. Sec.  59.3, 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 
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, new definitions of ``Family 
Planning'' and ``Grantee'';
0
b. Revising the definition of ``Low income family''; and
0
c. Adding, in alphabetical order, new definitions of ``Program and 
project'', and ``Subrecipient''.
    The revisions and additions read as follows:


Sec.  59.2  Definitions.

* * * * *
    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 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 include preconceptional 
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 never coercive and are 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 percent of the most recent Poverty Guidelines issued pursuant to 42 
U.S.C. 9902(2). ``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:

[[Page 25530]]

    (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) With respect to contraceptive services, a woman can be 
considered from a ``low-income family'' if she has health insurance 
coverage through an employer which does not provide the contraceptive 
services sought by the woman because it has a sincerely held religious 
or moral objection to providing such coverage.
* * * * *
    Program and project are used interchangeably and 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.
* * * * *
    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?

    Any public or nonprofit private entity in a State may apply for a 
grant 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 and 
other fertility-awareness based methods) and services (including 
infertility services, including 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.
* * * * *
    (5) Not provide, promote, refer for, support, or present abortion 
as a method of family planning.
* * * * *
    (12) 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.
    (13) Ensure transparency in the delivery of services by reporting 
the following information in grant applications and all required 
reports:
    (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.
    (14) Encourage 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).
    (b) * * *
    (1) Provide for medical services related to family planning 
(including physician's consultation, examination prescription, and 
continuing supervision, laboratory examination, contraceptive supplies) 
and necessary referral to other medical facilities when medically 
indicated, consistent with Sec.  59.14(a), and provide for the 
effective usage of contraceptive devices and practices.
* * * * *
    (8) Except as provided in Sec.  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. Revise Sec.  59.7 to 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 amounts?

    (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.
    (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 
provision of the regulation (or include the entire regulation) within 
the Funding Announcement, and shall require each applicant to describe 
their plans for affirmative compliance with each provision.
    (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), which meet all of the statutory and 
regulatory requirements and restrictions, and where 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 is 
demonstrated in the proposal and the applicant shows capacity to make 
rapid and effective use of grant funds, including and especially

[[Page 25531]]

among a broad range of partners and diverse subrecipients and referral 
individuals and organizations, and among non-traditional Title X 
partnering organizations.
    (3) The degree to which the applicant takes into account the number 
of 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 patients.
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. Sec.  59.13 through 59.19 to subpart A to read as follows:
Sec.
* * * * *
59.13 Standards of compliance with prohibition on abortion.
59.14 Prohibition on referral for abortion.
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.


Sec.  59.13  Standards of compliance with prohibition on abortion.

    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.  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  Prohibition on referral for abortion.

    (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 any other affirmative action to assist a patient to 
secure such an abortion. If asked, a medical doctor may provide a list 
of licensed, qualified, comprehensive health service providers (some, 
but not all, of which also provide abortion, in addition to 
comprehensive prenatal care), but only if a woman who is currently 
pregnant clearly states that she has already decided to have an 
abortion. This list is only to be provided to a woman who, of her own 
accord, makes such a request. The list shall not identify the providers 
who perform abortion as such. All other patients will be provided, upon 
request, a list of licensed, qualified, comprehensive health service 
providers (including providers of prenatal care) who do not provide 
abortion as a part of their services.
    (b) Referral for prenatal services. 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 must be referred for 
appropriate prenatal and/or social services (such as prenatal care and 
delivery, infant care, foster care, or adoption), and shall be given 
assistance with setting up a referral appointment to optimize the 
health of the mother and unborn child. She must also be provided with 
information necessary to protect her health and the health of the 
unborn child until such a time as the referral appointment is kept. 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 emergency medical services.
    (c) Use of permitted referrals to encourage abortion. 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. Recognizing, however, the duty 
of a physician to promote patient safety, a doctor may, if asked, 
provide a list of licensed, qualified, comprehensive health service 
providers (some of which also provide abortion, in addition to 
comprehensive prenatal care). Such information related to abortion is 
permitted only if a woman who is currently pregnant clearly states that 
she has already decided to have an 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 otherwise promote abortion as a method of family planning.
    (e) Examples. (1) A pregnant client of a Title X project requests 
prenatal care services, which project personnel are qualified to 
provide. Because the provision of such services is outside the scope of 
family planning supported by Title X, the client must be referred to 
appropriate providers of prenatal care. Provision of prenatal services 
within the Title X project is inconsistent with this part.
    (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 comprehensive care 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 her a list of 
licensed, qualified health care professionals in the area (some of whom 
provide abortion as part of their primary health care services). The 
list includes, among other licensed, qualified, comprehensive health 
care providers, a local health care professional who provides abortions 
in addition to comprehensive prenatal care. Inclusion of this provider/
clinic on the list is consistent with paragraph (a) 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 that provide prenatal care 
and abortions. None of the entries on the list are providers that 
principally provide abortions. Although there are several appropriate 
licensed, qualified providers of prenatal care in the area that do not 
provide or refer for abortions, none of these providers are included on 
the list. Provision of the list

[[Page 25532]]

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 project counselor 
tells her that the project does not consider abortion a method of 
family planning and therefore does not refer for abortion. The 
counselor further tells the client that the project can help her to 
obtain prenatal care and necessary social services, and provides her 
with a list of such providers from which the client may choose. Such 
actions are consistent with paragraph (a) 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 does not constitute 
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.  59.13, 59.14, and 59.16 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. 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. Prohibited actions include the 
use of Title X project funds for the following:
    (1) Lobbying for the passage of legislation to increase in any way 
the availability of abortion as a method of family planning;
    (2) Providing speakers or educators who, in the Title X project or 
the use of Title X project funds, promote the use of abortion as a 
method of family planning;
    (3) Attending events or conferences during which the grantee or 
subrecipient engages in lobbying;
    (4) 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;
    (5) Using legal action to make abortion available in any way as a 
method of family planning; and
    (6) Developing or disseminating in any way materials (including 
printed matter, audiovisual materials and web-based materials) 
advocating abortion as a method of family planning or otherwise 
promoting a favorable attitude toward abortion.
    (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)(6) of this section.
    (2) A Title X project makes an appointment for a pregnant client 
with an abortion clinic. The Title X project has violated paragraph (a) 
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. Payment of dues to the association violates paragraph (a)(4) 
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)(4) 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)(1) 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)(1) 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) 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) 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 implemented a plan to comply with State laws 
Such plan shall include, at a minimum, policies and procedures with 
respect to

[[Page 25533]]

such notification and reporting 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 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; 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 teen who 
presents with a sexually transmitted disease (STD), pregnancy, or any 
suspicion of abuse, in order to rule out victimization of a minor. Such 
screening would be required with respect to any individual who is under 
the age of consent in the state of the proposed service area. 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 where 
required by law, 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 sole purpose of ensuring compliance with the 
requirements of this section.


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 with 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 
give a detailed accounting for the use of grant dollars, both in their 
applications for funding, and within any annually required reporting. 
Further, any significant change in the usage of grant funds within the 
grant cycle shall not be undertaken without the approval of the Office 
of Population Affairs.
    (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 any possible misuse of 
Title X funds through misbilling or overbilling, or any other 
unallowable expense.


Sec.  59.19  Transition provisions.

    (a) In accordance with Sec.  59.15, with respect to the requirement 
for physical separation that is effective after [DATE OF PUBLICATION OF 
THE FINAL RULE IN THE FEDERAL REGISTER], covered entities must comply 
with the applicable new requirements [DATE 1 year after the publication 
of the final rule].
    (b) In accordance with Sec.  59.15, with respect to the requirement 
for financial separation is effective after [DATE OF PUBLICATION OF THE 
FINAL RULE IN THE FEDERAL REGISTER], covered entities must comply with 
the applicable new requirements no later than [DATE 60 days AFTER 
PUBLICATION OF THE FINAL RULE].
    (c) In regards to all other requirements are effective after [DATE 
OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], covered 
entities must comply no later than 60 days following publication of the 
final rule.

    Dated: May 24, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-11673 Filed 5-29-18; 4:15 pm]
 BILLING CODE 4150-34-P