[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
-----------------------------------------------------------------------
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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: http://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 http://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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
[[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.
---------------------------------------------------------------------------
\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'').
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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), http://www.modernhealthcare.com/article/20120906/INFO/309069993; Wang, A.,
Medicaid Probes Planned Parenthood Fees, Crain's Chicago Business
(July 9, 2012), http://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) http://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/index.html.
---------------------------------------------------------------------------
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), http://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), http://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),
http://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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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/index.html.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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