Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services, 19812-19833 [2021-07762]
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Federal Register / Vol. 86, No. 71 / Thursday, April 15, 2021 / Proposed Rules
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[FR Doc. 2021–07334 Filed 4–14–21; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 59
RIN 0937–AA11
Ensuring Access to Equitable,
Affordable, Client-Centered, Quality
Family Planning Services
Office of the Secretary, U.S.
Department of Health and Human
Services (HHS).
ACTION: Proposed rule.
AGENCY:
The Office of Population
Affairs (OPA), in the Office of the
Assistant Secretary for Health, proposes
to revise the rules issued on March 4,
2019, establishing standards for
compliance by family planning services
projects authorized by Title X of the
Public Health Service Act. Those rules
have undermined the public health of
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SUMMARY:
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the population the program is meant to
serve. The Department proposes to
revise the 2019 rules by readopting the
2000 regulations, with several
modifications needed to strengthen the
program and ensure access to equitable,
affordable, client-centered, quality
family planning services for all clients,
especially for low-income clients.
DATES: To ensure consideration,
comments must be received by May 17,
2021.
ADDRESSES: You may submit comments,
identified by Regulatory Information
Number 0937–AA11, by any of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Enter the above
docket ID number in the ‘‘Enter
Keyword or ID’’ field and click on
‘‘Search.’’ On the next web page, click
on ‘‘Submit a Comment’’ and follow the
instructions.
• Mail or Hand Delivery [For paper,
disk, or CD–ROM submissions] to: Attn:
Title X Rulemaking, Office of
Population Affairs, Office of the
Assistant Secretary for Health, U.S.
Department of Health and Human
Services, 200 Independence Avenue
SW, Washington, DC 20201. Comments,
including any personally identifiable or
confidential businesses information,
received prior to the close of the
comment period will be posted without
change to https://www.regulations.gov.
While the Department welcomes
comments on any aspect of the
regulations, we particularly welcome
comments concerning how the current
regulations have impacted the public’s
health or how this proposal to revise
them will promote public health and aid
in the program’s fundamental mission to
offer a broad range of effective family
planning methods with priority given to
clients from low-income families.
FOR FURTHER INFORMATION CONTACT:
Alicia Richmond Scott, Office of
Population Affairs, Office of the
Assistant Secretary for Health,
Department of Health and Human
Services, 200 Independence Avenue
SW, Washington, DC 20201; telephone:
240–453–2800; email: Alicia.richmond@
hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
II. Regulatory and Litigation Background
III. Public Health Impact as a Result of the
2019 Rules and Reason for This Proposal
IV. Proposed Rules
A. Section 59.2 Definitions
B. Section 59.5 What requirements must
be met by a family planning project?
C. Section 59.6 What procedures apply to
ensure the suitability of informational
and educational material?
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D. Section 59.7 What criteria will the
Department of Health and Human
Services use to decide which family
planning services projects to fund and in
what amount?
E. Section 59.10 Confidentiality
F. Section 59.12 What other HHS
regulations apply to grants under this
subpart?
V. Regulatory Impact Analyses
A. Introduction
B. Summary of Costs, Benefits, and
Transfers
C. Preliminary Economic Analysis of
Impacts
a. Background
b. Market Failure or Social Purpose
Requiring Federal Regulatory Action
c. Purpose of the Proposed Rule
d. Baseline Conditions and Impacts
Attributable to the Proposed Rule
e. Further Discussion of Distributional
Effects
f. Uncertainty and Sensitivity Analysis
g. Analysis of Regulatory Alternatives to
the Proposed Rule
VI. Environmental Impact
VII. Paperwork Reduction Act
I. Statutory Background
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 as a means of
‘‘making comprehensive voluntary
family planning services readily
available to all persons desiring such
services.’’ 1 Section 1001 of the Act (42
U.S.C. 300(a)), as amended, authorizes
the Secretary of Health and Human
Services ‘‘to make grants to and enter
into contracts with public or nonprofit
private entities to assist in the
establishment and operation of
voluntary family planning projects
which shall offer a broad range of
acceptable and effective family planning
methods and services (including natural
family planning methods, infertility
services, and services for adolescents).’’
Section 1006 of the Act (42 U.S.C. 300a–
4) ensures that priority of services is
given to clients from low-income
families and authorizes the Secretary to
promulgate regulations governing the
program.
Enacted as part of the original Title X
legislation, Section 1008 of the Act (42
U.S.C. 300a–6) directs that ‘‘None of the
funds appropriated under this title shall
be used in programs where abortion is
a method of family planning.’’ The
Conference Report accompanying the
legislation 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
1 Public Law 91–572 (‘‘The Family Planning
Services and Population Research Act of 1970’’),
section 2(1).
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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.). This requirement has been
reiterated by later Congresses through
annual appropriations provisos that
state: ‘‘[A]mounts provided to said
[voluntary family planning] projects
under such title shall not be expended
for abortions.’’ See, e.g., Consolidated
Appropriations Act, 2021, Public Law
116–260, Div. H, 134 Stat 1182, 1570.
Since 1970 when Title X was first
enacted, Congress has amended the law
several times both through changes to
the Title X statute itself and through
yearly appropriations riders. For
example, in 1975, Congress amended
Title X to include ‘‘natural family
planning methods’’ as part of the broad
range of family planning methods to be
offered by Title X projects.2 PHS Act
1001(a) (42 U.S.C. 300(a)). In 1978,
Congress amended Title X to codify
HHS past practice by specifically
requiring that Title X projects include
‘‘services for adolescents.’’ 3 PHS Act
1001(a) (42 U.S.C. 300(a)). The Act was
again amended in 1981 to provide that
‘‘[t]o the extent practicable, entities
which receive grants or contracts under
this subsection shall encourage family
participation in projects under this
subsection.’’ 4 PHS Act sec. 1001(a) (42
U.S.C. 300(a)).
Congress has also imposed additional
requirements through annual
appropriations riders. For example,
since Fiscal Year (FY) 1996, the annual
Title X appropriation includes the
proviso that ‘‘all pregnancy counseling
shall be nondirective.’’ 5 See, e.g.,
Consolidated Appropriations Act, 2021,
Public Law 116–260, Div. H, 134 Stat
1182, 1570 (2021). Also since FY 1996,
the Title X appropriation has directed
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.’’
2 Public
Law 94–63.
Law 95–613. The amendment reflected
Congress’ intent to place ‘‘a special emphasis on
preventing unwanted pregnancies among sexually
active adolescents.’’ S. Rep. No 822, 95th Cong, 2d
sess. 24 (1978).
4 Omnibus Budget Reconciliation Act of 1981,
Public Law 97–35, sec. 931(b)(1), 95 Stat. 357, 570
(1981).
5 Omnibus Consolidated Rescissions and
Appropriations Act, 1996, Public Law 104–134,
Title II, 110 Stat.1321, 1321–221 (1996).
Id. Since FY 1998, 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.’’ 6 See, e.g.,
Consolidated Appropriations Act, 2021,
Public Law 116–260, Div. H, sec. 207,
134 Stat. 1182, 1590. 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. And, since FY 1999, in a
separate rider, Congress has required
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.’’ 7 See, e.g., Consolidated
Appropriations Act, 2021, Public Law
116–260, Div. H, sec. 208, 134 Stat.
1182, 1590 (2021).
II. Regulatory and Litigation
Background
The Department first promulgated
regulations for the Title X program in
1971 but did not directly address
section 1008. 36 FR 18465 (Sept. 15,
1971). With experience, the Department
interpreted section 1008 to prohibit
grantees 8 from promoting or
encouraging abortion as a method of
family planning in any way and to
require that Title X activities be separate
and distinct from any abortion
activities. 53 FR 2922, 2923 (Feb. 2,
1988) (describing the Department’s
interpretation in the early years of the
program). In 1981, the Department built
upon this experience and issued
guidelines directing grantees to provide
‘‘nondirective counseling’’ to pregnant
clients ‘‘upon request’’ including: (1)
Prenatal care and delivery; (2) infant
care, foster care, or adoption; and (3)
pregnancy termination. Counseling
included ‘‘referral upon request.’’ OPA,
Program Guidelines for Project Grants
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6 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).
7 Department of Health and Human Services
Appropriations Act, 1999, Public Law 105–277,
Title II, sec. 219, 112 Stat. 2681, 2681–363 (1998).
8 For purposes of this notice of proposed
rulemaking, the terms ‘‘grantee’’ and ‘‘recipient’’ are
used interchangeably.
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for Family Planning Services at 13
(1981).
In 1988, reacting in large part to a
directive from President Reagan, the
Department changed course. 53 FR 2922
(Feb. 2, 1988). Regulations promulgated
then—commonly called the ‘‘gag
rule’’—prohibited the discussion of or
referral for abortion. The regulations
also required grantees to maintain strict
physical and financial separation
between Title X projects and abortion
related activities, to be determined by
the ‘‘facts and circumstances’’ of each
grantee. Additionally, the regulations
prohibited lobbying, education, duespaying, or any other activities which
could be interpreted to encourage or
promote abortion as a method of family
planning.
The 1988 regulations were
immediately subject to multiple
lawsuits and ultimately upheld by the
Supreme Court in Rust v. Sullivan, 500
U.S. 173 (1991). In Rust, the Supreme
Court held that section 1008 was
‘‘ambiguous’’ and ‘‘at no time did
Congress directly address the issues of
abortion counseling, referral or
advocacy.’’ Id at 185. The Court was
nearly unanimous on this point.
Blackmun dissenting at 207; O‘Connor
Dissenting at 223.9 Given the lack of
clarity regarding section 1008, the Court
deferred to the Secretary’s construction
of the statute as ‘‘reasonable’’ under
Chevron U.S.A. v. NRDC, 467 U.S. 837
(1984).
The Court also upheld the regulations
against constitutional attack under the
Fifth and First Amendments. Following
recent precedent, the Court held that the
Government could constitutionally
subsidize some activities over others
and that plaintiffs were still free to
pursue abortion related activities and
speech ‘‘when they are not acting under
the auspices of the Title X project.’’ Id.
at 199.
On November 5, 1991, responding to
widespread concerns over the
regulation’s overreach into the doctorpatient relationship, President Bush
issued a directive to the Department to
allow for open communications
between doctors and patients for all
aspects of their medical condition. See
Nat’l Family Planning & Reprod. Health
Ass’n v. Sullivan, 979 F.2d 227 (D.C. Cir
1992). However, the Department did not
engage in rulemaking to carry out the
directive, as required by the
Administrative Procedure Act.
Therefore, the D.C. Court of Appeals
9 Justice Stevens, the only Justice to find the
§ 1008 unambiguous, believed it ‘‘plainly’’
foreclosed the Secretary’s regulations. Stevens
dissent at 221.
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upheld a lower court injunction
prohibiting the directives from taking
effect. Id.
Almost immediately after taking
office, President Clinton issued a
memorandum to the Secretary of HHS,
directing suspension of the ‘‘gag rule’’
and commencement of new rulemaking
regarding the Title X program. 58 FR
7455 (Feb. 5, 1993). The Department
suspended the 1988 regulations and
adopted compliance standards
predating the 1988 rules on an interim
basis. 58 FR 7462 (Feb. 5, 1993). The
Department also sought comment on
adopting as final the rules and guidance
in effect prior to the 1988 rules. 58 FR
7464 (Feb. 5, 1993). In response to this
proposed rulemaking, the Department
received 146 comments, and finalized
new Title X rules in July of 2000. 65 FR
41270 (July 3, 2000). On that same day,
the Department published
interpretations relating to the statutory
requirement that no funds appropriated
under Title X of the Public Health
Service Act be used in programs in
which abortion is a method of family
planning. 65 FR 41281 (July 3, 2000).
The new rules rescinded the 1988
rules prohibiting counseling and referral
for abortion. They also eliminated the
provisions requiring strict physical and
financial separation between Title X
projects and abortion related activities,
while still requiring that abortion and
Title X activities are separated by more
than ‘‘mere bookkeeping.’’ 65 FR 41270,
41271. Section 59.10 concerning
lobbying restrictions was also repealed,
while still adhering to long established
interpretations of the statute forbidding
promotion of abortion through advocacy
activities. Id. at 41277. Finally, the
Department codified the 1981 guidance
requiring, upon request of the pregnant
patient, nondirective counseling and
referral, regarding any option requested:
‘‘(1) prenatal care and delivery; (2)
infant care, foster care, or adoption; and
(3) pregnancy termination.’’ Id. at 41279
[42 CFR 59.5(a)(5) (2000 reg)].
In promulgating the 2000 regulations,
the Department concluded that revoking
the 1988 regulations was within its
administrative discretion and that there
was no evidence the ‘‘gag rule’’ would—
or could—work in practice. The
Department concluded experience had
taught that the rules and policies
previous to the 1988 regulations had
been accepted by grantees and enabled
the program to operate successfully
during virtually its entire history.
Additionally, the Department relied on
the direction from Congress in
appropriations riders beginning in 1996
(Pub. L. 104–134), requiring that ‘‘all
pregnancy counseling be nondirective,’’
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believing any referral to a prenatal or
other provider when not requested
would raise real questions of coercion.
The rule also incorporated referrals as a
‘‘logical and appropriate outcome’’ of
nondirective counseling and consistent
with the requirement that the project
provide referrals for any medical
services not provided by the project [42
CFR 59.5(b)(1)]. Id. 41274. For two
decades after these rules were finalized
(and nearly three decades after they had
been in place following the 1988 rule’s
suspension in 1993), Title X faced no
litigation or controversy over these
regulations.10
In 2018, under a new Administration,
the Department proposed new rules
again. 83 FR 25502 (June 1, 2018). These
rules largely mirrored the 1988
regulations and were finalized in 2019.
84 FR 7714 (March 24, 2019). The
Department promulgated the 2019 rules
because of its stated view, at that time,
that they represented the best
interpretation of the statute and
provided the most appropriate guidance
for compliance with the statutory
provisions, including section 1008.
While pointing to no direct violations of
Title X, associated laws, or the 2000
regulations, the Department believed the
2000 regulations ‘‘fostered an
environment of ambiguity surrounding
appropriate Title X activities.’’ Id. at
7721. Therefore, ‘‘bright line rules’’
would ameliorate any confusion by
grantees and the public.
The Department also cited several
conscience protection laws enacted by
Congress to support the changes to the
2000 regulations. These laws prohibit
public health service grantees from
requiring individuals to assist in the
performance of health service activities
against their religious beliefs or
convictions, 42 U.S.C. 300a-7(d), and
prohibit discrimination against both
individual and institutional providers
for their refusal to provide, cover, or
refer for abortions. Consolidated
Appropriations Act, 2021, Public Law
116–260, Div. H, sec. 507(d) (2020),
Consolidated Appropriations Act, 2021,
Public Law 116–260, Div. H, sec. 507(d)
(2020). The Department concluded in
2019 that the 2000 regulations, if
enforced against objecting grantees,
would be inconsistent with these
statutory protections and dissuade
otherwise qualified providers from
applying for Title X funds.
The 2019 rules also re-imposed the
physical separation provisions of the
10 As discussed below, the 2000 rule also fully
recognized the statutory conscience right of
individual providers to object to counseling and
referral for abortions. Id. At 41274, 41275.
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1988 rule, as well re-codifying the
lobbying restrictions. Additionally, the
rule added requirements on grantees
and subrecipients regarding compliance
with state reporting laws, as well as
expanded application and recordkeeping requirements. And, with
respect to minors, the 2019 rule
required providers to document what
specific actions were taken to encourage
family participation.
As to nondirective counseling and
referral for abortion, in recognition of
the Congressional direction for
nondirective counseling on abortion in
yearly appropriations riders, the 2019
rule allowed, but did not require,
counseling by grantees, limited to
physicians and advanced care
providers. Id. at 7744. However, the
Department believed that the abortion
referral requirement was inconsistent
with section 1008 and that, though
permissible for nearly the entire history
of the program, such referrals must be
prohibited. Id.
Litigation over the 2019 rule
immediately ensued. The Department
was sued by 23 states, every major
medical organization, Title X grantee
organizations, and individual grantees.
The suits were lodged in multiple
district courts and alleged a variety of
claims under the Administrative
Procedure Act, the Affordable Care Act,
and the Constitution. The rule was
ultimately upheld by an en banc Court
of Appeals for the Ninth Circuit and
enjoined (only as to the state of
Maryland) by a district court in
Maryland in a decision upheld by the en
banc Court of Appeals for the Fourth
Circuit. Both court of appeals decisions
were issued over substantial dissents.
In California v. Azar, 950 F.3d 1067
(9th Cir. 2020), the Ninth Circuit relied
heavily on Rust in upholding the rule.
A majority of the en banc panel found
that the Department ‘‘could’’ interpret
section 1008 as it did in the 2019 rule,
and nothing in subsequent legislation
prevented this reading. Id. at 1085. The
Ninth Circuit upheld the rule against an
arbitrary and capricious challenge,
stating, ‘‘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.’’ Id. at
1097 (emphasis in original). Conversely,
a majority of the Fourth Circuit found
the Department’s 2019 rule arbitrary and
capricious. Mayor of Baltimore v. Azar,
973 F.3d 258 (4th Cir. 2020). The Fourth
Circuit also held the 2019 rule violated
the non-directive mandate.11
11 Both the Ninth and Fourth Circuits also came
to opposite results on the validity of the rule under
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Losing parties in both cases sought
review from the Supreme Court in
October of 2020. The Court granted
certiorari on February 22, 2021,
consolidating the cases. No. 20–429. On
March 12, 2021, the parties stipulated to
dismiss the cases under Supreme Court
Rule 46.1.
III. Public Health Impact as a Result of
the 2019 Rules and Reason for this
Proposal
The 2019 rule split courts and judges
on its approach, its reasonableness, and
the interpretation of subsequent
legislative provisions. Still, no court
questioned the Supreme Court’s
fundamental holding in Rust that
section 1008 is ‘‘ambiguous.’’ And,
while section 1008 may be ambiguous,
the public health consequences of the
previous Administration’s interpretation
of the statute are not. The following
outlines the effects of the 2019 rule:
• The number of family planning
services grantees has dropped
precipitously, resulting in an adverse
impact on the number of clients served.
After the implementation of the 2019
Title X Final Rule, 19 Title X grantees
out of 90 total grantees, 231
subrecipients, and 945 service sites
immediately withdrew from the Title X
program. Overall, the Title X program
lost more than 1,000 service sites. Those
service sites represented approximately
one quarter of all Title X-funded sites in
2019. Title X services are not currently
available at all in six states (HI, ME, OR,
UT, VT, and WA) and are only available
on a very limited basis in six additional
states (AK, CT, MA, MN, NH, and NY).
California, the single-largest Title X
project in the nation (before the 2019
Final Rule) had 128, or 36 percent, of its
Title X service sites withdraw from the
program, leaving more than 700,000
patients without access to Title Xfunded care. Similarly, in New York, the
number of Title X-funded service sites
dropped from 174 to just two, leaving
more than 328,000 patients without
Title X-funded care. All Planned
Parenthood affiliates—which in 2015
had served 41 percent of all clients at
Title X service sites—withdrew from
Title X due to the 2019 Final Rule.12
The withdrawal of numerous grantees,
subrecipients, and service sites
adversely impacted the number of
clients served under the Title X
program. With the 2019 Final Rule only
being in place for five and a half
months, the remaining 71 Title X
section 1554 of the Affordable Care Act [42 U.S.C.
18114].
12 (Kaiser Family Foundation, 2020). Current
Status of the Title X Network and the Path Forward.
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grantees served 844,083 fewer clients as
compared to the previous year, prior to
the change in the regulations.
Specifically, 3,939,749 clients were
served in 2018; 3,095,666 clients were
served in 2019, an approximately 22
percent decrease.13
• Low-income, uninsured, and racial
and ethnic minorities’ access to Title X
family planning services has decreased,
thereby contributing to the increase in
health inequities and unmet health
needs within these populations.
Compared to 2018 Family Planning
Annual Report (FPAR) data prior to the
implementation of the 2019 Final Rule,
in 2019, 573,650 fewer clients under
100 percent of the Federal poverty level
(FPL); 139,801 fewer clients between
101 percent to 150 percent FPL; 65,735
fewer clients between 151 percent and
200 percent FPL; and, 30,194 fewer
clients between 201 percent to 250
percent FPL received Title X services.
This contradicts the purpose and intent
of the Title X program, which is to
prioritize and increase family planning
services to low-income clients.
Additionally, 324,776 fewer uninsured
clients were served in 2019 compared to
2018. FPAR data also demonstrate that
in 2019 compared to 2018, 128,882
fewer African Americans; 50,039 fewer
Asians; 6,724 fewer American Indians/
Alaska Natives; 7,218 fewer Native
Hawaiians/Pacific Islanders; and,
269,569 fewer Hispanics/Latinos
received Title X services.14
• Provision of critical family planning
and related preventive health services
has decreased dramatically.15 The
impact of the 2019 Final Rule has been
devastating to the hundreds of
thousands of Title X clients who have
lost access to critical family planning
and related preventive health services
due to service delivery gaps created by
the 2019 Final Rule. More specifically,
compared to 2018, 225,688 fewer clients
received oral contraceptives; 49,803
fewer clients received hormonal
implants; and 86,008 fewer clients
received IUDs. Additionally, 90,386 and
188,920 fewer Papanicolaou (Pap) tests
and clinical breast exams respectively
were performed in 2019 compared to
2018. Confidential human
immunodeficiency virus (HIV) tests
decreased by 276,109. Sexually
transmitted infection (STI) testing
13 (OPA, 2020). Family Planning Annual Report:
2019 National Summary Report. Accessed on March
9, 2021 from https://opa.hhs.gov/sites/default/files/
2020-09/title-x-fpar-2019-national-summary.pdf.
14 (OPA, 2020). Family Planning Annual Report:
2019 National Summary Report. Accessed on March
9, 2021 from https://opa.hhs.gov/sites/default/files/
2020-09/title-x-fpar-2019-national-summary.pdf.
15 Ibid.
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19815
decreased by 256,523 for chlamydia, by
625,802 for gonorrhea, and by 77,524 for
syphilis. Furthermore, 71,145 fewer
individuals who were pregnant or
sought pregnancy were served. As a
result of the dramatic decline in Title X
services provided, the 2019 Final Rule
undermined the mission of the Title X
program by helping fewer individuals in
planning and spacing births, providing
fewer preventive health services, and
delivering fewer screenings for STIs.
Adolescent services were also adversely
affected. In 2019, 151,375 fewer
adolescent clients received family
planning services and 256,523 fewer
women under the age of twenty-five
were tested for chlamydia.16
The true impact of the 2019 Final
Rule in terms of long-term sexual and
reproductive health negative sequelae in
the lives of hundreds of thousands of
low-income clients and clients of color
is difficult to quantify. As a result of the
decrease in clients able to receive Title
X services, it is estimated that the 2019
Final Rule may have led to up to
181,477 unintended pregnancies.17
Unintended pregnancies increase the
risk for poor maternal and infant
outcomes. Individuals having a birth
following an unintended pregnancy are
less likely to have benefitted from
preconception care, to have optimal
spacing between births, and to have
been aware of their pregnancy early on,
which in turn makes it less likely that
they would have received prenatal care
early in pregnancy.18 19 The 2019 Final
Rule likely also resulted in additional
costs to taxpayers as a result of an
increase in unintended pregnancies,
16 (OPA, 2020). Family Planning Annual Report:
2019 National Summary Report. Accessed on March
9, 2021 from https://opa.hhs.gov/sites/default/files/
2020-09/title-x-fpar-2019-national-summary.pdf.
17 Estimating that of the 844,083 fewer clients
served by Title X in 2019 compared to 2018, 21.5%
of those clients could have experienced an
unintended pregnancy as a result of not receiving
services. Formula taken from Guttmacher Institute
(2017). Unintended pregnancies prevented by
publicly funded family planning services: Summary
of results and estimation formula. Accessed on
March 8, 2021 from https://www.guttmacher.org/
sites/default/files/pdfs/pubs/Guttmacher-Memo-onEstimation-of-Unintended-Pregnancies-PreventedJune-2017.pdf.
18 Jessica D. Gipson, Michael A. Koenig, and
Michelle J. Hindin. ‘‘The Effects of Unintended
Pregnancy on Infant, Child, and Parental Health: A
Review of the Literature.’’ Studies in family
planning 39.1 (2008): 18–38. Web.
19 Power to Decide. Maternal and Infant Health
and the Benefits of Birth Control in America.
Accessed on March 8, 2020 from https://
powertodecide.org/sites/default/files/resources/
supporting-materials/getting-the-facts-straightchapter-3-maternal-infant-health.pdf.
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preterm and low-birthweight births,
STIs, infertility, and cervical cancer.20
• OPA has been unable to secure new
Title X grantees and service sites to
meet the unmet need for family
planning services. To meet the unmet
need for family planning services
nationwide, in Fiscal Year 2019 OPA
issued a competitive supplemental
funding announcement to existing
grantees. Fifty existing grantees were
awarded $33.7 million to expand Title
X services. However, only 7 states (CO,
DE, KY, ND, NM, NV, TX) had a
meaningful increase in the number of
Title X clinics in their states.
In addition, OPA has been unable to
find new grantees to fill most of the gaps
the 2019 Final Rule created, including
in the six states that lost all Title Xfunded services. To address gaps in the
Title X service network and increase
coverage, a new competitive funding
announcement was issued in Fiscal
Year 2020 to provide services in
unserved or underserved states and
communities. The number of
applications received was so low (8
eligible applications received) that the
resulting grant awards were for less than
the total amount of funding available
(grant awards for $8.5 million with $20
million available), and were only able to
provide services in three states with no
or limited Title X services at the time.
This demonstrated the negative effects
of the 2019 Title X Final Rule on client
access to needed family planning and
related preventive health services,
especially for the priority low-income
populations that Title X is mandated to
serve.
The realization of a greater pool of
grantees, as predicted by the 2019 rule,
has not transpired over the course of
two grant cycles. As discussed above,
OPA was unable to meaningfully
expand services nor was it able to find
new grantees to fill existing gaps. In
fact, the 2019 Final Rule did not
increase the pool of grantees and was
unable to generate interest in providing
Title X services from organizations who
had not previously been Title X
grantees. This, coupled with the exodus
of otherwise qualified grantees,
subrecipients and service sites that left
the network due to their opposition to
the 2019 Final Rule, led to great
difficulty in awarding appropriated
funds as intended by Congress.
• The 2019 Final Rule is contrary to
the CDC and OPA’s Quality Family
Planning (QFP) Guidelines. In April
2014 (with updates in 2015 and 2017),
20 Kaiser Family Foundation. https://www.kff.org/
womens-health-policy/issue-brief/data-note-impactof-new-title-x-regulations-on-network-participation/
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Providing Quality Family Planning
Services: Recommendations from
Centers for Disease Control and
Prevention and the US Office of
Population Affairs (QFP),21 was
published as a CDC Morbidity and
Mortality Weekly Report (MMWR)
Recommendations and Reports. The
QFP, developed jointly by the Centers
for Disease Control and Prevention
(CDC) and the HHS Office of Population
Affairs (OPA), provides
recommendations for use by all
reproductive health and primary care
providers with patients who are in need
of services related to preventing or for
achieving pregnancy. The QFP are
scientific and evidence-based
recommendations that integrate and fill
gaps in existing guidelines for the
family planning settings. QFP
recommendations are based on a
rigorous, systematic, transparent review
of the evidence and with input from a
broad range of clinical experts, OPA,
and CDC. The QFP references numerous
other clinical guidelines that are
published by Federal agencies, as well
as guidelines released by professional
medical associations.
These guidelines were developed over
a three-year period through the CDC’s
Division of Reproductive Health (DRH)
and OPA, in consultation with a wide
range of experts and key stakeholders.
These guidelines have been the
undisputed standard in reproductive
healthcare ever since. QFP
recommendations support all providers
in delivering quality family planning
services and define family planning
services within a broader context of
preventive services, to improve health
outcomes for women, men, and their
(future) children.
The client centered approach adopted
in the QFP requires pregnancy tests to
be ‘‘followed by a discussion of options
and appropriate referrals.’’ Id. at 14
Further, counseling and referral are to
be provided, ‘‘at the request of the
client,’’ in accordance with
recommendations from professional
medical organizations. Though formally
adopted as a QFP recommendation in
2014, appropriate referrals with
nondirective counseling have been the
practice and implicit standard of care in
Title X programs for essentially its
entire history, including in early
guidelines and later when expressly
incorporated in the 2000 regulations.
21 CDC. Providing Quality Family Planning
Services—Recommendations from CDC and the
U.S. Office of Population Affairs. Accessed on
March 8, 2021 from https://opa.hhs.gov/grantprograms/title-x-service-grants/about-title-x-servicegrants/quality-family-planning.
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The 2019 rule abandoned this client
centered approach over the objection of
every major medical organization
without any countervailing public
health rationale. Moreover, the 2019
rule required prenatal referral even over
the objection of the patient. For the
reasons discussed above, that approach
cannot be squared with well-accepted
public health principles.
• The 2019 Final Rule increased
compliance and oversight costs, with no
discernible benefit. The 1988 rules
requiring strict physical and financial
separation requirements, were based, in
part, on two governmental reports
finding minor compliance issues with
grantees and recommended only more
specific guidance, not a substantial
reworking of the regulations. See, e.g.,
Comp. Gen. Rep. No GAO/HARD–HRD–
82–106 (1982), at 14–15; 65 FR 41270,
41272. While those reports found some
confusion among grantees around
section 1008, ‘‘GAO found no evidence
that Title X funds had been used for
abortions or to advise clients to have
abortions.’’ More importantly, in the
decades between 1993 and the 2019
rule, and as evidenced by the silence of
the 2019 final rule on this issue, legally
required audits, regular site visits, and
other oversight of grantees have found
no diversion of grant funds that would
justify the greatly increased compliance
and oversight costs the 2019 rule
required.
The 2019 rule’s separation
requirements also claimed to be
addressing questions of ‘‘fungibility’’
and a concern that Title X funds might
be ‘‘intentionally or unintentionally’’
co-mingling with activities not allowed
under the statute. 84 FR at 7716. As
noted, close oversight for decades under
the 2000 rules uncovered no
misallocation of Title X funds by
grantees. Moreover, courts have long
since held that governments cannot
restrict access to funds for one activity
simply because it may ‘‘free up’’ funds
for another activity. See Planned
Parenthood of Cent. & N. Arizona v.
Arizona, 718 F.2d 938, 945 (9th Cir
1983) (concluding ‘‘as a matter of law,
the freeing-up theory cannot justify
withdrawing all state funds from
otherwise eligible entities merely
because they engage in abortion-related
activities disfavored by the state’’); see
also Agency for Int’l Dev. v. Alliance for
Open Soc’y Int’l, Inc., 570 U.S. 205, 220
(2013) (‘‘[I]f the Government’s argument
[that fungibility is sufficient for
prohibition] were correct, League of
Women Voters would have come out
differently, and much of the reasoning
of Regan and Rust would have been
beside the point’’). Because of the 2019
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rule, appropriations that would
otherwise be used to carry out the
purposes of the Title X program,
providing a broad range of family
planning services to individuals
(including confidential services to
minors), are now being diverted to
increased infrastructure costs resulting
from the separation requirement as well
as the micro-level monitoring and
reporting now required of grantees.
None of these burdensome additional
requirements provide discernible
compliance benefits, particularly not to
public health. As many commenters and
at least one court emphasized, the 2019
rule was a solution in search of a
problem, a solution whose severe public
health consequences caused much
greater problems.
The Department also recognizes
Congress has passed several laws
protecting the conscience rights of
providers, particularly in the area of
abortion. For example, in promulgating
the 2000 Title X rules, the Department
affirmed: ‘‘under 42 U.S.C. 300a–7(d),
grantees may not require individual
employees who have such objections [to
abortion] to provide such counseling.’’
65 FR 41270, 41274 (July 3, 2000). Since
2005 Congress has also annually
enacted an appropriations rider which
extends non-discrimination protections
to other ‘‘health care entities’’ who
refuse to counsel or refer for abortion.
See, e.g., Consolidated Appropriations
Act, 2021, Public Law 116–260, Div. H,
section 507(d) (2020). Under these
statutes, objecting providers or Title X
grantees are not required to counsel or
refer for abortions.22 However, such
protections for objecting providers and
grantees should not prohibit willing
providers and grantees from providing
information in accordance with the
ethical codes of major medical
organizations.
Ultimately, continued enforcement of
the 2019 rule raises the possibility of a
two-tiered healthcare system in which
those with insurance and full access to
healthcare receive full medical
information and referrals, while lowincome populations with fewer
opportunities for care are relegated to
inferior access. Given that so many
individuals depend on the Title X
program as their primary source of
healthcare, this situation creates a
widespread public health concern. The
22 This has been the consistent position of the
Department since 2000. See 65 FR at 41274 (in
response to comments on individual objections to
providing abortion counseling or referral,
Department stating: ‘‘under 42 U.S.C. 300a–7(d),
grantees may not require individual employees who
have such objections to provide such counseling.’’).
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2019 rule is not in the best interest of
public health.
IV. Proposed Rules
For nearly 50 years without
interruption, Title X program grants
have been administered against the
backdrop of counseling and referral for
appropriate medical care, including
referral for abortion. Family planning is
widely considered one of the most
important public health achievements of
the 20th Century.23 As the only Federal
program exclusively dedicated to
providing contraceptive services, Title X
has been imperative to that success.
For five decades, Title X family
planning clinics have played a critical
role in ensuring access to a broad range
of family planning and related
preventive health services for millions
of low-income or uninsured individuals
and others. 24 Over the 50 years of the
Title X program, Title X clinics have
served more than 190 million clients:
182.2 million women, 8.1 million men,
comprising 139.5 million adults and
50.8 million adolescents, across 50
states, the District of Columbia, and
eight U.S. territories and freely
associated states. Title X providers
offered clients a broad range of effective
and medically safe contraceptive
methods approved by the U.S. Food and
Drug Administration. Title X-funded
sexually transmitted infection (STI) and
human immunodeficiency virus (HIV)
screening services prevented
transmission and adverse health
consequences. Over the 50 years of the
Title X program, Title X clinics also
performed 34.1 million chlamydia tests,
18.3 million HIV tests, 37 million
Papanicolaou tests, and 42 million
clinical breast exams.
Given the previous success of the
program, the large negative public
health consequences of maintaining the
2019 rules, the substantial compliance
costs for grantees, and the lack of
tangible benefits, the Department
proposes revoking the 2019 Title X
regulations. As has been clearly borne
out by case law and history, the
Department has the discretion to make
this determination and it is in the
interest of public health.
The Department is also concerned
that some state policies restricting
eligible subrecipients unnecessarily
23 Centers. for Disease Control & Prevention,
Achievements in Public Health, 1900–1999: Family
Planning, 48 Morbidity & Mortality Weekly Reports
No. 47, 1073–80 (Dec. 3, 1999), https://
www.cdc.gov/mmwr/preview/mmwrhtml/
mm4847a1.htm.
24 OPA. Title X: Celebrating 50 Years of Title X
Service Delivery. Accessed on March 8, 2021 from
https://opa.hhs.gov/sites/default/files/2020-11/titlex-50-years-infographic.pdf.
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19817
interfere with beneficiaries’ access to
the most accessible and qualified
providers. These state restrictions are
not always related to the subrecipients’
ability to effectively deliver Title X
services, but rather are sometimes based
either on the non-Title X activities of
the providers or because they are a
certain type of provider. However,
providers with a reproductive health
focus often provide a broader range of
contraceptive methods on-site and
therefore may reduce additional barriers
to accessing services. Moreover, denying
participation by family planning
providers that can provide effective
services has resulted in populations in
certain geographic areas being left
without Title X providers for an
extended period of time.25 And, while
many otherwise qualified providers are
willing and can provide effective Title
X services, some lack the administrative
capacity to directly apply for and
manage a Title X grant.
The Department believes that these
state restrictions on subrecipient
eligibility unrelated to the ability to
deliver Title X services undermine the
mission of the program to ensure widely
available access to services by the most
qualified providers. Therefore, the
Department invites comment on ways in
which it can ensure that Title X projects
do not undermine the program’s
mission by excluding otherwise
qualified providers as subrecipients.
In place of the 2019 Title X
regulations, the Department proposes to
largely readopt the 2000 regulations (65
FR 41270) with several revisions aimed
at ensuring access to equitable,
affordable, client-centered, quality
family planning services. Advancing
equity for all, including people of color
and others who have been historically
underserved, marginalized, and
adversely affected by persistent poverty
and inequality, is a priority for OPA and
the Title X program. By focusing on
advancing equity in the Title X program,
we can create opportunities for the
improvement of communities that have
been historically underserved, which
benefits everyone. Additionally, given
the success of the Providing Quality
Family Planning Services guidelines
published in 2014,26 the Department is
25 Carter, M.W., Gavin, L., Zapata, L.B., Bornstein,
M., Mautone-Smith, N., & Moskosky, S.B. (2016).
Four aspects of the scope and quality of family
planning services in U.S. publicly funded health
centers: Results from a survey of health center
administrators. Contraception. doi:10.1016/
j.contraception.2016.04.009.
26 CDC. Providing Quality Family Planning
Services—Recommendations from CDC and the
U.S. Office of Population Affairs. Accessed on
March 8, 2021 from https://opa.hhs.gov/grant-
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proposing to incorporate into
regulations several of the QFP’s
recommendations. Based on experience,
the Department is also proposing some
provisions it believes will make the
program function more effectively,
efficiently and consistently for all.
The Department proposes revising the
2019 Title X Final Rule through notice
and comment rulemaking, by readopting
the 2000 regulations with revisions that
will enhance the Title X program and its
family planning services, including
family planning services provided using
telemedicine, for the future. This will
remove the 2019 Final Rule
requirements for strict physical and
financial separation, allow Title X
providers to provide nondirective
options counseling, and allow Title X
providers to refer their patients for all
family planning related services desired
by the client, including abortion
services. In addition, this will allow for
several revisions that are needed to
strengthen the program and ensure
access to equitable, affordable, clientcentered, trauma-informed quality
family planning services for all clients,
especially for low-income clients. At the
same time, the proposed rule will retain
the longstanding prohibition on directly
promoting or performing abortion that
follows from Section 1008’s text and
subsequent appropriations enactments.
And as indicated above, individuals and
grantees with conscience objections will
not be required to follow the proposed
rule’s requirements regarding abortion
counseling and referral.
For all the above reasons, the
Department proposes to revise the
regulations that govern the Title X
family planning services program by
readopting the 2000 regulations (65 FR
41270), with several modifications. The
proposed revisions to the 2000
regulations and rationale for each are
listed below:
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A. Section 59.2
Definitions
The Department proposes to revise
§ 59.2 to include a modified definition
of family planning. The definition of
family planning services included in the
2019 Final Rule did not align with the
widely accepted definition. The
definition of family planning services
should be consistent with the Title X
statutory requirements and reflect the
widely-recognized definition that is
included in Providing Quality Family
Planning Services: Recommendations of
CDC and the U.S. Office of Population
programs/title-x-service-grants/about-title-x-servicegrants/quality-family-planning.
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Affairs,27 which has been used
historically by OPA when implementing
the program prior to 2019. Under the
proposed regulations, ‘‘family planning
services’’ are defined as including a
broad range of medically approved
contraceptive services, which includes
FDA-approved contraceptive services
and natural family planning methods,
for clients who want to prevent
pregnancy and space births, pregnancy
testing and counseling, assistance to
achieve pregnancy, basic infertility
services, sexually transmitted infection
(STI) services, and other preconception
health services.
The Department also proposes to add
definitions for terms used throughout
the revised regulations to provide
clarity. The newly proposed definitions
include adolescent-friendly health
services,28 client-centered care,29 health
equity,30 inclusivity,31 quality 32
healthcare, service site, and traumainformed.33
The proposed definition for ‘‘service
site’’ is adapted from previous Title X
Family Planning Guidelines that
implemented the 2000 regulations, the
2014 Program Requirements for Title X
Funded Family Planning Projects
(hereafter ‘‘2014 Title X Program
Requirements’’).34 ‘‘Service site’’ is
27 CDC. Providing Quality Family Planning
Services—Recommendations from CDC and the
U.S. Office of Population Affairs. Accessed on
March 8, 2021 from https://opa.hhs.gov/grantprograms/title-x-service-grants/about-title-x-servicegrants/quality-family-planning.
28 World Health Organization. Quality
Assessment Guidebook. A guide to assessing health
services for adolescent clients. Geneva, World
Health Organization, 2009. Accessed on March 8,
2021 from https://apps.who.int/iris/handle/10665/
44240.
29 CDC. Providing Quality Family Planning
Services—Recommendations from CDC and the
U.S. Office of Population Affairs. Accessed on
March 8, 2021 from https://opa.hhs.gov/grantprograms/title-x-service-grants/about-title-x-servicegrants/quality-family-planning.
30 CDC. Health Equity. Accessed on March 12,
2021 from https://www.cdc.gov/chronicdisease/
healthequity/index.htm.
31 White House. Executive Order on Advancing
Racial Equity and Support for Underserved
Communities Through the Federal Government.
Accessed on March 8, 2021 from https://
www.whitehouse.gov/briefing-room/presidentialactions/2021/01/20/executive-order-advancingracial-equity-and-support-for-underservedcommunities-through-the-federal-government/.
32 Institute of Medicine. Crossing the Quality
Chasm: A New Health System for the 21st Century.
Accessed on March 8, 2021 from https://
www.ncbi.nlm.nih.gov/books/NBK222274/.
33 SAMHSA. SAMHSA’s Concept of Trauma and
Guidance for a Trauma-Informed Approach.
Accessed on March 8, 2021 from https://
ncsacw.samhsa.gov/userfiles/files/SAMHSA_
Trauma.pdf.
34 OPA. 2014 Program Requirements for Title X
Funded Family Planning Projects. Accessed on
March 8, 2021 from https://
www.nationalfamilyplanning.org/
document.doc?id=1462.
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defined as a clinic or other location
where Title X services are provided to
clients. The Title X grantees and/or their
subrecipients may have services sites.
The proposed definition of service site
will assist Title X grantees in more
accurately reporting data on their
subrecipient and service sites and will
eliminate confusion in the OPA Title X
clinic locator database.
All other proposed definitions are
used by Federal Government agencies or
major medical associations, and
include:
Adolescent-friendly health services
are services that are accessible,
acceptable, equitable, appropriate and
effective for adolescents.35
Client-centered care is respectful of,
and responsive to, individual client
preferences, needs, and values; client
values guide all clinical decisions.36
Culturally and linguistically
appropriate services are respectful of
and responsive to the health beliefs,
practices and needs of diverse
patients.37
Health equity is achieved when every
person has the opportunity to attain
their full health potential and no one is
disadvantaged from achieving this
potential because of social position or
other socially determined
circumstances.38
Inclusivity ensures that all people are
fully included and can actively
participate in and benefit from family
planning, including, but not limited to,
individuals who belong to underserved
communities, such as Black, Latino, and
Indigenous and Native American
persons, Asian Americans and Pacific
Islanders and other persons of color;
members of religious minorities;
lesbian, gay, bisexual, transgender, and
queer (LGBTQ+) persons; persons with
disabilities; persons who live in rural
areas; and persons otherwise adversely
affected by persistent poverty or
inequality.39
35 World Health Organization. Quality
Assessment Guidebook. A guide to assessing health
services for adolescent clients. Geneva, World
Health Organization, 2009. Accessed on March 8,
2021 from https://apps.who.int/iris/handle/10665/
44240.
36 CDC. Providing Quality Family Planning
Services—Recommendations from CDC and the
U.S. Office of Population Affairs. Accessed on
March 8, 2021 from https://opa.hhs.gov/grantprograms/title-x-service-grants/about-title-x-servicegrants/quality-family-planning.
37 Office of Minority Health. What is Cultural and
Linguistic Competence? Accessed on March 8, 2021
from https://minorityhealth.hhs.gov/omh/
browse.aspx?lvl=1&lvlid=6.
38 CDC. Health Equity. Accessed on March 12,
2021 from https://www.cdc.gov/chronicdisease/
healthequity/index.htm.
39 White House. Executive Order on Advancing
Racial Equity and Support for Underserved
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Quality healthcare is safe, effective,
client-centered, timely, efficient, and
equitable.40
Trauma-informed is a program,
organization, or system that realizes the
widespread impact of trauma and
understands potential paths for
recovery; recognizes the signs and
symptoms of trauma in clients, families,
staff, and others involved with the
system; and responds by fully
integrating knowledge about trauma into
policies, procedures, and practices, and
seeks to actively resist retraumatization.41
The Department also proposes a
technical corrections to § 59.2 to replace
‘‘grantee’’ with ‘‘recipient’’ in the
regulatory text to align with the way the
term is used in Federal and HHS
regulations.
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B. Section 59.5 What requirements
must be met by a family planning
project?
The Department proposes revising
§ 59.5(a)(1) to define what constitutes a
broad range of acceptable and effective
family planning methods and services.
The proposed revision revises the 2000
regulations by removing the existing
ambiguity and defining what constitutes
a broad range of acceptable and effective
family planning methods and services.
The revised definition of the broad
range of methods and services is aligned
with the definition used in practice/
policy guidance. Moreover, the same
definition is included in CDC and
OPA’s Recommendations for Providing
Quality Family Planning Services.42
This revision will result in increased
equitable access to a broad range of
family planning methods and services to
all Title X clients and more clarity in
defining those services.
The Department proposes revising
§ 59.5(a)(1) to require service sites that
do not offer a broad range of family
planning methods and services on-site
to provide clients with a referral for
where they can access the broad range
and ensure, when feasible, that the
Communities Through the Federal Government.
Accessed on March 8, 2021 from https://
www.whitehouse.gov/briefing-room/presidentialactions/2021/01/20/executive-order-advancingracial-equity-and-support-for-underservedcommunities-through-the-federal-government/.
40 Institute of Medicine. Crossing the Quality
Chasm: A New Health System for the 21st Century.
Accessed on March 8, 2021 from https://
www.ncbi.nlm.nih.gov/books/NBK222274/.
41 SAMHSA. SAMHSA’s Concept of Trauma and
Guidance for a Trauma-Informed Approach.
Accessed on March 8, 2021 from https://
ncsacw.samhsa.gov/userfiles/files/SAMHSA_
Trauma.pdf.
42 CDC (2014). Providing Quality Family Planning
Services, Recommendations of CDC and the U.S.
Office of Population Affairs. MMWR, 63(4).
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referral provided does not unduly limit
client access to services, such as
excessive distance or travel time to the
referral location or referral to services
that are cost-prohibitive for the client.
While an organization that offers only a
single method of family planning may
participate as part of a Title X project as
long as the entire project offers a broad
range of family planning services,
offering only a single method of family
planning could unduly limit Title X
clients, especially low-income clients,
by reducing access to a client’s method
of choice. The Department proposes
revising the 2000 regulations to require
sites that do not offer the broad range of
methods on-site to be able to provide
clients with a referral to a provider who
does offer the client’s method of choice.
In addition, the referral provided must
be client-centered and not unduly limit
access to the client’s method of choice.
This revision will help to improve
access to client-centered services.
The Department proposes to revise
§ 59.5(a)(3) so that family planning
services are required to be clientcentered, culturally and linguistically
appropriate, inclusive, traumainformed, and ensure equitable and
quality service delivery consistent with
nationally recognized standards of care.
This revision to the 2000 regulations is
aimed at increasing access and ensuring
equity in all services provided, which is
especially important for the Title X
program that prioritizes services for
low-income clients. Including within
the regulation a specific focus on
services that are client-centered,
culturally and linguistically
appropriate, inclusive, traumainformed, and ensure equitable and
quality service delivery will result in
improved services provided to clients.
These new terms are defined in the
proposed regulation under § 59.2, and
the added definitions were derived from
existing definitions in use by the
Federal Government or major medical
associations.
The Department proposes revising
§ 59.5(a)(8) to include widely accepted
practices on grant billing practices that
were included in previous Title X
Family Planning Guidelines. These
revisions incorporate language that was
included in the 2014 Title X Program
Requirements. The 2014 Title X
Program Requirements were developed
to assist grantees in understanding and
implementing the family planning
services grants. The 2014 Title X
Program Requirements described the
various requirements applicable to the
Title X program, as set out in the Title
X statute and implementing regulations,
and in other applicable Federal statutes,
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19819
regulations, and policies. These billing
practices, which are widely accepted in
the Title X community, indicate that: (1)
Family income should be assessed
before determining whether copayments
or additional fees are charged; and (2)
insured clients whose family income is
at or below 250% FPL should not pay
more (in copayments or additional fees)
than what they would otherwise pay
when the schedule of discounts is
applied. These revisions address areas
of confusion for grantees prior to the
2014 Title X Program Requirements that
were clarified in that document.
The Department proposes adding
§ 59.5(a)(9) to ensure grantee income
verification policies align with the
mission of Title X services being
prioritized for low-income clients. This
addition aims to address an area of
common confusion among Title X
grantees, which has resulted, in some
instances, in a burden being placed on
low-income clients. First, a requirement
is added (using text from the previous
2014 Title X Program Requirements) to
indicate that grantees should take
reasonable measures to verify client
income. In addition, a new requirement
is added to use client self-reported
income if the income cannot be verified
after reasonable attempts. Without this
additional statement, several Title X
grantees have established policies to
charge full price for services following
unsuccessful attempts to verify income,
even when the self-reported income is
below 250% of the Federal poverty level
(FPL) and would have otherwise
qualified for no or reduced cost services.
This proposed revision will greatly
improve accessibility and affordability
of services for low-income clients
consistently across all Title X grantees.
The Department proposes adding
§ 59.5(a)(12) to retain some, but not all,
language from the 2019 Final Rule on
notification or reporting of child abuse,
child molestation, sexual abuse, rape,
incest, intimate partner violence or
human trafficking. The notification and
reporting requirements are important for
Title X providers as mandatory reporters
under state laws and protect Title X
clients. In addition, this regulation
formalizes requirements contained in an
annual appropriations rider related to
Title X that Congress has included since
FY 1999, requiring 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.’’
The Department proposes adding
§ 59.5(a)(13) to describe requirements
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related to subrecipient monitoring and
reporting. This addition requires Title X
grantees to report on the subrecipients
and referral agencies involved in their
Title X projects, and to provide their
plan for oversight and monitoring of
their subrecipients in grantee reports.
The regulation no longer requires
grantees to report detailed information
about each subrecipient and referral
agency such as location and specific
expertise, which will reduce the
increased reporting burden required by
the 2019 Final Rule.
The Department proposes revising
§ 59.5(b)(1) to acknowledge that
consultation for medical services related
to family planning can be provided by
healthcare providers beyond the
physician. The proposed revision
acknowledges that consultation for
healthcare services related to family
planning may be by a physician, but
may also be by other healthcare
providers, including physician
assistants and nurse practitioners.
The Department proposes revising
§ 59.5(b)(3)(iii) to reflect the desire to
engage diverse individuals to make
services accessible. This revision adds
language to clarify the intent at engaging
diverse individuals to ensure access to
equitable, affordable, client-centered,
quality family planning services.
The Department proposes revising
§ 59.5(b)(8) to add language to the
existing 2000 regulation text to include
primary healthcare providers in the list
of referrals and to state that referrals are
to be to providers in close proximity
when feasible to the Title X site in order
to promote access to services and
provide a seamless continuum of care.
The Department also proposes
including several technical corrections
to § 59.5. The technical correction
proposed in §§ 59.5(a)(4) and 59.6(b)(2)
replaces the word ‘‘handicapped
condition’’ with ‘‘disability’’ in both
sections in order to avoid negative
connotations and correct outdated
terminology. The technical correction
proposed to § 59.5(a)(5) replaces the
word ‘‘women’’ with ‘‘client’’, and the
technical correction proposed to
§ 59.5(a)(6) and (7) replaces the word
‘‘persons’’ with ‘‘clients’’ to use
inclusive language. The technical
correction proposed to § 59.5(a)(11)
replaces the term ‘‘sub-grantees’’ with
‘‘subrecipients’’. The technical
correction proposed to § 59.5(b)(3)
clarifies that focus of this section is on
community education, participation,
and engagement, and should not be
confused with the Information and
Education Advisory Committee
requirement under § 59.6.
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C. Section 59.6 What procedures apply
to ensure the suitability of informational
and educational material?
The Department proposes deleting
prior § 59.5(a)(11) related to the
Advisory Committee and consolidating
with § 59.6; and revising § 59.6 to clarify
intent and remove areas of confusion for
grantees regarding the Advisory
Committee and other miscellaneous
other provisions. The 2000 regulations
included information about the
Information & Education Advisory
Committee in two sections
(§§ 59.5(a)(11) and 59.6, which was
confusing to Title X grantees. The result
is that this revision consolidates all of
the Advisory Committee information in
one place, under section § 59.6.
In addition, the Department is
proposing several minor revisions to
clarify that the regulation applies to
both print and electronic materials, that
the upper limit on council members
should be determined by the grantee,
that the factors to be considered for
broad representation on the Advisory
Committee match the definition of
inclusivity earlier in the regulation, and
that materials will be reviewed for
medical accuracy, cultural and
linguistic appropriateness, and
inclusivity and to ensure they are
trauma-informed.
D. Section 59.7 What criteria will the
Department of Health and Human
Services use to decide which family
planning services projects to fund and
in what amount?
The Department proposes enabling
the Department to consider the ability of
the applicant to advance health equity
when awarding grant funds. Advancing
health equity is critical to the mission
of the Title X program. Adding this
additional criterion to the 2000
regulations brings the total number of
criteria from seven to eight.
E. Section 59.8 How is a grant
awarded?
The Department proposes a technical
correction to revise § 59.8 to change
‘‘project period’’ to ‘‘anticipated period’’
since HHS is in the process of adopting
revised definition and project period
will no longer be used.
F. Section 59.10 Confidentiality.
The Department proposes revising
§ 59.10 to include a widely accepted
practice related to client confidentiality.
This proposed revision will add a
widely accepted practice in the Title X
community that had been previously
included in the 2014 Title X Program
Requirements, indicating that
reasonable efforts must be made to
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collect charges without jeopardizing
client confidentiality. The Department
believes that the Title X program will be
strengthened by including this
clarification within the revised 2000
regulations.
In addition, the Department proposes
adding a requirement that grantees must
inform the client of any potential for
disclosure of their confidential health
information to policyholders where the
policyholder is someone other than the
client. Since state and local laws may
vary across jurisdictions (e.g., some are
likely to result in notification to the
policyholder that the client has received
services, others provide for an ‘‘opt out’’
process whereby the client can elect that
such a notification will not be made),
this addition will ensure that the client
understands the implications for using
their insurance and the options
available for them to maintain
confidentiality.
G. Section 59.11
Conditions
Additional
The Department proposes revising
§ 59.11 to add ‘‘during’’ the period of
the award to allow for imposition of
additional conditions, during the period
of award in addition to ‘‘prior to and at
the time of any award’’, under
circumstances where recipient
performance or organizational risk
change, e.g. if a recipient is failing to
perform we may impose new conditions
mid-award to require corrective action
per 45 CFR 75.207.
H. Section 59.12 What other HHS
regulations apply to grants under this
subpart?
The Department proposed a technical
correction to § 59.12 to update the
regulations that apply to 42 CFR part 59,
subpart A. The proposal includes a
reference to 45 CFR part 87 (‘‘Equal
Treatment for Faith-based
Organizations’’) on the list of
regulations that apply to the Title X
family planning services program.
V. Regulatory Impact Analyses
A. Introduction
HHS has examined the impacts of the
proposed rule under Executive Order
12866 on Regulatory Planning and
Review, Executive Order 13563 on
Improving Regulation and Regulatory
Review, Executive Order 13132 on
Federalism, the Regulatory Flexibility
Act (5 U.S.C. 601–612), and the
Unfunded Mandates Reform Act of 1995
(Pub. L. 104–4). Executive Orders 12866
and 13563 direct HHS to assess all costs
and benefits of available regulatory
alternatives and, when regulation is
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necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). HHS believes that
this proposed rule is not an
economically significant regulatory
action as defined by Executive Order
12866 because it would not result in
annual effects in excess of $100 million.
The Regulatory Flexibility Act
requires HHS to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. The proposed rule, if finalized,
would lessen administrative burdens for
grantees of all sizes. Therefore, the
Secretary certifies this proposed rule, if
finalized, would not have a significant
economic impact on a substantial
number of small entities under the
Regulatory Flexibility Act, 5 U.S.C. 605.
Section 202 of the Unfunded
Mandates Reform Act of 1995
(Unfunded Mandates Act) (2 U.S.C.
1532) requires HHS to 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 $158
million, using the most current (2020)
Implicit Price Deflator for the Gross
Domestic Product. This proposed rule
would not result in an expenditure in
any year that meets or exceeds this
amount.
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. The proposed rule will not
have a significant impact on state funds
as, by law, project grants must be
funded with at least 90 percent Federal
funds. 42 U.S.C. 300a–4(a). The
Department has determined that this
proposed rule does not impose such
costs or have any federalism
implications. The Department expects
that while some states may not support
the policies contained in this proposed
rule, many states and local health
departments will support the policies
contained in this proposed rule, and
that it will increase participation by
states (many of who dropped out under
the 2019 rule).
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B. Summary of Costs, Benefits and
Transfers
This proposed rule would revise the
2019 Final Rule by readopting the 2000
regulations, with several modifications,
and returning the program to the
compliance regime as it existed prior to
the 2019 rule’s implementation. The
proposed approach would allow the
Title X program grantees, subrecipients,
and service sites to have a greater
impact on public health than under the
current regulatory approach.
We predict that this proposed rule
would increase the number of grantees
receiving Title X funds. In turn, the
additional service sites supported by
funding would result in additional
clients served under the program. These
clients receive access to contraception,
public health screening including
clinical breast exams and Papanicolau
(Pap) testing, and testing for sexually
transmitted infections. These services
result in a reduction in unintended
pregnancy, earlier detection of breast
and cervical cancer, and earlier
detection of sexually transmitted
infections including chlamydia,
gonorrhea, syphilis, and human
immunodeficiency virus (HIV). This
screening and testing can result in
significant cost savings from earlier
treatment and other interventions. This
proposed rule would also increase the
diversity of grantees receiving funds,
including geographic diversity to states
that do not currently have a Title X
grantee.
The proposed rule would also focus
grantees on providing services in a
manner that is client-centered,
culturally and linguistically
appropriate, inclusive, and traumainformed; protects the dignity of the
individual; and ensures equitable and
quality service delivery. This focus is
especially important for the Title X
program that prioritizes services for
low-income clients.
This regulatory impact analysis
reports the activity occurring at Title X
funded sites to provide policymakers
with this information. However, the
direct impact within the program does
not account for services that continue to
be provided at sites not receiving Title
X funding, filling the gap left by
providers that withdrew from the
program following the restrictions
placed on funding included in the 2019
Final Rule.
C. Preliminary Economic Analysis of
Impacts
a. Background
The Title X National Family Planning
Program, administered by the U.S.
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19821
Department of Health and Human
Services (HHS), Office of Population
Affairs (OPA), is the only Federal
program dedicated solely to supporting
the delivery of family planning and
related preventive healthcare. The
program is designed to provide ‘‘a broad
range of acceptable and effective family
planning methods and services
(including natural family planning
methods, infertility services, and
services for adolescents)’’ with priority
given to persons from low-income
families. In addition to offering these
methods and services on a voluntary
and confidential basis, Title X-funded
service sites provide contraceptive
education and counseling; breast and
cervical cancer screening; sexually
transmitted infections (STIs) and HIV
testing, referral, and prevention
education; and pregnancy diagnosis and
counseling. The program is
implemented through competitively
awarded grants to state and local public
health departments and family
planning, community health, and other
private nonprofit agencies. In fiscal year
2021, the Title X program received
approximately $286.5 million in
discretionary Federal Title X funding.
On March 4, 2019, HHS published a
final rule to ‘‘prohibit family planning
projects from using Title X funds to
encourage, promote, provide, refer for,
or advocate for abortion as a method of
family planning; require assurances of
compliance; eliminate the requirement
that Title X projects provide abortion
counseling and referral; require physical
and financial separation of Title X
activities from those which are
prohibited under section 1008; provide
clarification on the appropriate use of
funds in regard to the building of
infrastructure, and require additional
reporting burden from grantees.’’
b. Market Failure or Social Purpose
Requiring Federal Regulatory Action
The regulatory impact analysis
associated with the 2019 Final Rule
predicted that the additional restrictions
on grantees would result in ‘‘an
expanded number of entities interested
in participating in Title X.’’ Further, the
analysis suggested the 2019 Final Rule
would result in ‘‘enhanced patient
service and care.’’ Contrary to these
predictions, during the initial period of
the 2019 Final Rule’s implementation,
the policy appears to have had the
opposite effect. As we describe in
greater detail in the Baseline Section,
the restrictions included in the 2019
Final Rule are associated with a
substantial reduction in the number of
Title X grantees, subrecipients, and
service sites, resulting in a
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corresponding reduction in total clients
served. This is particularly troubling,
since the Title X program serves a lowincome population that is particularly
vulnerable to losing access to these
services. This proposed rule is needed
to improve the functioning of
Government and the effectiveness of the
Title X program.
c. Purpose of the Proposed Rule
This proposed rule would revise the
regulations that govern the Title X
family planning services program by
revoking the 2019 Final Rule and
readopting the 2000 regulations with
several modifications. The proposed
approach would allow the Title X
program grantees, subrecipients, and
service sites to have a greater impact on
public health than under the current
regulatory approach.
d. Baseline Conditions and Impacts
Attributable to the Proposed Rule
We adopt a baseline that assumes the
requirements of the 2019 Final Rule
remain in place over the period of our
analysis. To characterize the real-world
impact of the Title X program under this
regulatory approach, we develop an
annual forecast of grantees,
subrecipients, service sites, and total
clients served. The key inputs to our
forecast are historical data on Title X
service grantees. For fiscal years 2016–
2019, this information is summarized in
the 2019 Title X Family Planning
Annual Report. We supplement this
information with unpublished
preliminary estimates of the impact for
fiscal year 2020. Table D1 summarizes
these data.
TABLE D1—TITLE X SERVICE GRANTEES
Year
Grantees ..............................................................................
Subrecipients .......................................................................
Service Sites ........................................................................
Clients Served ......................................................................
2016
2017
2018
2019
2020
91
1,117
3,898
4,007,552
89
1,091
3,858
4,004,246
99
1,128
3,954
3,939,749
100
1,060
3,825
3,095,666
73
803
2,682
1,536,744
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Source: Title X Family Planning Annual Report, 2019: Exhibit A–2a, and unpublished preliminary estimates for FY2020.
The data for fiscal years 2016–2019
included all grantees, subrecipients, and
service sites operating at any time
during the year. The adoption of the
2019 Title X Final Rule occurred midyear in 2019. Following this regulation,
19 grantees, 231 subrecipients, and 945
service sites withdrew from the Title X
program. The reduced number of
grantees, subrecipients, services sites,
and clients served observed in 2019 and
2020 cannot be explained by a reduction
in discretionary funding for the
program, which has remained constant
at $286.5 million throughout this time
period. Since the 2019 figure includes
clients served by these service sites for
about half of the year, adopting 3.1
million clients served as an annual
forecast would likely overstate activity
in the program under the current
regulations. Indeed, preliminary figures
for FY2020 indicate that only about 1.5
million clients were served. However,
this figure likely represents an
underestimate for a typical year of the
program under the current regulations
since services were likely disrupted by
the ongoing public health emergency.
As our primary estimate, we adopt
2,512,066 clients served as the baseline
annual impact of Title X under the
policies of the 2019 Final Rule. This 2.5
million corresponds to the number of
clients served in 2019 among remaining
grantees as of March 2021. For
comparison, this primary estimate
represents a 37% reduction in clients
served compared to the average of
clients served from 2016 to 2018. In the
Uncertainty and Sensitivity Analysis
Section, we adopt the 1.5 million client
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figure as a lower-bound estimate, and
3.1 million clients as an upper-bound
estimate of the annual program impact
under the baseline.
Table D2 summarizes our baseline
forecast for the same categories of
historical data presented in Table D1.
We adopt the current count for grantees,
subrecipients, and services sites. We
assume these figures will be constant
over time horizon of this analysis.
oral contraceptives and IUDs, this was
a 27% reduction; and for hormonal
implants, a 21% reduction. These
percentages are similar in magnitude to
the 21% reduction in clients served in
2019 compared to 2018. Additionally,
90,386 and 188,920 fewer Pap tests and
clinical breast exams, respectively, were
performed in 2019 compared to 2018.
Confidential HIV tests decreased by
276,109. Testing for sexually
transmitted infections (STIs) decreased
TABLE D2—BASELINE FORECAST OF
by 256,523 for chlamydia, by 625,802
TITLE X SERVICES
for gonorrhea, and by 77,524 for
syphilis.
Baseline forecast
Annual
For our forecast of services provided
Grantees ...............................
73 under our baseline scenario, we adopt
Subrecipients ........................
803 the most recent percentage of clients
Service Sites .........................
2,682 receiving each service in the 2019 Title
Clients Served ......................
2,512,066 X Family Planning Annual Report. For
example, in 2019, about 23% of female
In addition to the reduction in
clients received a clinical breast exam.
grantees, subrecipients, service sites,
We assume the same share of clients
and total client served, we note that six
will be served by Title X for screening
states currently have no Title X services, and sexually transmitted infection
including HI, ME, OR, UT, VT, and WA. testing. Table D3 reports our best
There are six additional states that have estimate of the annual services provided
limited Title X services, including AK,
under the baseline scenario. We
CT, MA, MN, NH, and NY.43
describe these services in greater detail
In line with the reduction in clients
later in this Section.
served under the 2019 Final Rule, data
also reveal a significant drop in services
TABLE D3—BASELINE TITLE X CANprovided For example, when comparing
CER SCREENING AND SEXUALLY
2019 figures to 2018, 225,688 fewer
TRANSMITTED INFECTION TESTING
clients received oral contraceptives;
49,803 fewer clients received hormonal
Year
Annual
implants; and 86,008 fewer clients
received intrauterine devices (IUDs). For
43 As
noted earlier, seven states (CO, DE, KY, ND,
NM, NV, TX) experienced a meaningful increase in
the number of Title X clinics after the 2019
regulatory change.
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Clinical Breast Exams ..........
Pap Tests .............................
Chlamydia Test .....................
Gonorrhea Test ....................
Syphilis Test .........................
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443,087
1,266,508
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the data from fiscal years 2016–2018,
the last three years of data that are
unaffected by the drops experienced
following the 2019 Final Rule.
Specifically, we adopt the average
across these three years as our long-run
Year
Annual
estimates. These averages are 93
Confidential HIV Test ...........
777,536 grantees, 1,112 subrecipients, 3,903
Source: Calculations based on Title X Fam- service sites, and about 4.0 million
ily Planning Annual Report, 2019: Exhibits 26 clients served.
and 29.
To complete our forecast of the policy
We predict that the main effect of the
scenario, we assume that it will take two
proposed rule would be to return to
years for program participation and
Title X program impact levels observed
clients served to achieve the long-run
prior to the 2019 Final Rule. Our
equilibrium estimates. This two-year
estimates of the long-run equilibrium of phase-in is consistent with a scenario in
grantees, subrecipients, service sites,
which most service sites that withdrew
and total client served are informed by
from the Title X program have remained
TABLE D3—BASELINE TITLE X CANCER SCREENING AND SEXUALLY
TRANSMITTED INFECTION TESTING—
Continued
19823
open, with some operating at a lower
capacity, than they did prior to the 2019
Final Rule. It is also consistent with an
expectation that many of the grantees
and service sites that withdrew from the
program would be able to rejoin if this
proposed rule were finalized. In year
one, following the effective date of the
proposed rule, the number of clients
served would increase to about 3.2
million. In year two, this number would
increase again to about 4.0 million and
remain there for the duration of our
analysis. These figures are presented in
Table D4. We acknowledge uncertainty
in this estimate, and include a
discussion in the Uncertainty and
Sensitivity Section, below.
TABLE D4—POLICY SCENARIO FORECAST OF TITLE X SERVICE GRANTEES
Year
Grantees ..............................................................................
Subrecipients .......................................................................
Service Sites ........................................................................
Clients Served ......................................................................
To characterize the effect of the
proposed rule, we compare the policy
scenario forecast to the baseline forecast
described in the previous section. Table
D5 reports the difference between these
2022
2023
2024
2025
2026
80
906
3,089
3,247,958
86
1,009
3,496
3,983,849
93
1,112
3,903
3,983,849
93
1,112
3,903
3,983,849
93
1,112
3,903
3,983,849
two scenarios, which represents the net
effect of the proposed rule. For example,
in year 1 after this rule is effective, the
number of clients served would be
about 736,000 higher than under the
baseline scenario. Approximately 88%
of clients served in 2016–2018 are
female, and we use this percentage to
estimate the increase in clients served
by sex under the policy scenario.
TABLE D5—EFFECT OF THE PROPOSED RULE ON TITLE X SERVICES
Year
2022
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Increase in Grantees ...........................................................
Increase in Subrecipients ....................................................
Increase in Service Sites .....................................................
Increase in Clients Served ...................................................
Female ..........................................................................
Male ..............................................................................
Clients served under the Title X
program experience outcomes that
include reducing unintended pregnancy
through greater access to contraception.
The averted unintended pregnancies
translate to a reduction in unplanned
births, a reduction in abortions, and
reduction in miscarriages. Also, Title X
clients receive cancer screenings and
testing for sexually transmitted
infections. These screenings and testing
can identify treatable conditions,
improving the quality of life and
extending the lives of beneficiaries. In
the case of sexually transmitted
infections, additional testing can reduce
the likelihood of further infections and
future infertility. This proposed rule
would expand service to
socioeconomically disadvantaged
populations, most of whom are female,
low income, and young. We discuss this
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7
103
407
735,892
648,996
86,896
2023
2024
2025
2026
13
206
814
1,471,783
1,297,992
173,791
20
309
1,221
1,471,783
1,297,992
173,791
20
309
1,221
1,471,783
1,297,992
173,791
20
309
1,221
1,471,783
1,297,992
173,791
in greater detail in the Section on
Distributional Effects.
To further explore the likely effect of
the Title X program on unintended
pregnancy, we rely on existing
methodology for estimating number of
unintended pregnancies prevented each
year among U.S. women who depend on
publicly funded family planning
services.44 Among this subgroup of
women who use any method of
contraception, 46 in 1,000 women are
expected to experience an unintended
pregnancy. This figure can be compared
to 296 unintended pregnancies per
44 Jennifer J. Frost and Lawrence B. Finer (2017).
Memo entitled ‘‘Unintended pregnancies prevented
by publicly funded family planning services:
Summary of results and estimation formula.’’
https://www.guttmacher.org/sites/default/files/
pdfs/pubs/Guttmacher-Memo-on-Estimation-ofUnintended-Pregnancies-Prevented-June-2017.pdf.
Accessed on March 14, 2021.
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1,000 women who are unable to access
public family planning services. We
apply this estimate of a reduction of 250
unintended pregnancies per 1,000
contraception clients to the number of
additional female clients served under
the Title X program who adopt any
method of contraception.
For year 1, we multiply 735,892
clients by 88% to yield 648,996 clients
who are women. Among female clients,
approximately 14% indicate they are
not using a method of contraception,
according to figures in the 2019 Title X
Family Planning Annual Report. We
reduce the potential number of clients
that would potentially reduce the
likelihood of an unintended pregnancy
by 14% to yield 558,205 clients
expected to benefit from a contraceptive
method. Approximately 47% of
unintended pregnancies result in
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unplanned births, 34% in abortion, and
19% in a miscarriage.45
TABLE D6—EFFECT OF THE PROPOSED RULE ON TITLE X-ASSOCIATED CONTRACEPTION
Year
2022
Clients Served ......................................................................
Women Served ....................................................................
Women Served Using Contraception ..................................
Unintended and unplanned
pregnancies increase the risk for poor
maternal and infant outcomes. Women
who give birth following an unintended
or unplanned pregnancy are less likely
to have benefitted from preconception
care, to have optimal spacing between
births, and to have been aware of their
pregnancy early on, which in turn
makes it less likely that they would
have received prenatal care early in
pregnancy.46 47
Title X funding recipients also
perform preventive health services such
as cervical and breast cancer screening,
and testing for sexually transmitted
735,892
648,996
558,205
2023
2024
2025
2026
1,471,783
1,297,992
1,116,411
1,471,783
1,297,992
1,116,411
1,471,783
1,297,992
1,116,411
1,471,783
1,297,992
1,116,411
infections, including chlamydia,
gonorrhea, syphilis, and HIV. Table D6
presents the effect of the proposed rule
on Title X-associated cervical and breast
cancer screenings. These figures are
calculated by multiplying the number of
additional women served by the
program in each year by about 23% for
clinical breast exams, of which 5%
result in a referral for further evaluation;
and 20% for Pap testing, of which 13%
with a result of atypical squamous cells
(ASC) that require further evaluation
and possibly treatment, and 1% of
which have a high-grade squamous
intraepithelial lesion (HSIL) 48 or higher,
indicating the presence of a more severe
condition.
Clinical breast exams can identify
women requiring further evaluation of
an abnormal finding. Pap test (or pap
smear test) results can indicate viral
infections that, when untreated, can
turn into cervical cancer. The Pap test
results can also detect cervical cancer
cells. At a population level, these
screenings save lives by helping women
identify cancer earlier, and preventing
other conditions from developing into
cancer.
TABLE D7—EFFECT OF THE PROPOSED RULE ON TITLE X-ASSOCIATED CERVICAL AND BREAST CANCER SCREENING
ACTIVITIES
Year
2022
Clinical Breast Exams ..........................................................
Referred ........................................................................
Pap Tests .............................................................................
Tests with ASC or higher .............................................
Tests with HSIL or higher .............................................
Table D7 presents the effect of the
proposed rule on Title X-associated
testing for sexually transmitted
infections among female clients. These
are calculated by adopting estimates
2023
149,269
7,463
129,799
17,304
195
298,538
14,927
259,598
34,609
391
that 49% of women are tested for
chlamydia; 55% for gonorrhea; 19% for
syphilis; and 28% for HIV. Table D6
presents the same information for men.
The share of male clients tested for
2024
298,538
14,927
259,598
34,609
391
2025
298,538
14,927
259,598
34,609
391
2026
298,538
14,927
259,598
34,609
391
these infections are the following: 61%
for chlamydia, 68% for gonorrhea, 39%
for syphilis, and 53% for HIV.
TABLE D8—ADDITIONAL WOMEN TESTED FOR SEXUALLY TRANSMITTED INFECTIONS UNDER TITLE X
Year
2022
Chlamydia ............................................................................
Gonorrhea ............................................................................
Syphilis .................................................................................
Confidential HIV ...................................................................
2023
318,008
356,948
123,309
181,719
636,016
713,895
246,618
363,438
2024
636,016
713,895
246,618
363,438
2025
636,016
713,895
246,618
363,438
2026
636,016
713,895
246,618
363,438
TABLE D9—ADDITIONAL MEN TESTED FOR SEXUALLY TRANSMITTED INFECTIONS UNDER TITLE X
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Year
2022
Chlamydia ............................................................................
Gonorrhea ............................................................................
Syphilis .................................................................................
45 Jennifer J. Frost, Lori F. Frohwirth, Nakeisha
Blades, Mia R. Zolna, Ayana Douglas-Hall, and
Jonathan Bearak (2017). ‘‘Publicly Funded
Contraceptive Services at U.S. Clinics, 2015.
https://www.guttmacher.org/sites/default/files/
report_pdf/publicly_funded_contraceptive_
services_2015_3.pdf. Accessed on March 14, 2021.
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2023
53,006
59,089
33,889
106,013
118,178
67,779
46 Jessica D. Gipson, Michael A. Koenig, and
Michelle J. Hindin. ‘‘The Effects of Unintended
Pregnancy on Infant, Child, and Parental Health: A
Review of the Literature.’’ Studies in family
planning 39.1 (2008): 18–38. Web.
47 Power to Decide. Maternal and Infant Health
and the Benefits of Birth Control in America.
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106,013
118,178
67,779
2025
106,013
118,178
67,779
2026
106,013
118,178
67,779
Accessed on March 8, 2020 from https://
powertodecide.org/sites/default/files/resources/
supporting-materials/getting-the-facts-straightchapter-3-maternal-infant-health.pdf.
48 HSIL is the abnormal growth of certain cells on
the surface of the cervix.
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TABLE D9—ADDITIONAL MEN TESTED FOR SEXUALLY TRANSMITTED INFECTIONS UNDER TITLE X—Continued
Year
2022
Confidential HIV ...................................................................
Table D8 reports the total clients
tested for sexually transmitted
infections. These tests can identify
treatable conditions that can cause
discomfort, permanent damage to
reproductive systems including
infertility, and in certain cases, death.
The 2019 Title X Family Planning
Annual Report indicates confidential
HIV testing identifies a positive case for
approximately 0.38% of all HIV tests
2023
46,055
2024
92,109
performed. If the proposed rule is
finalized, Title X would be associated
with identifying an additional 873
positive cases of HIV. In subsequent
years, this number would increase to
1,745. Testing for these sexually
transmitted infections can also reduce
the likelihood that an individual will
spread an infection. In addition to
testing, Title X-funded service sites also
provide HIV/AIDS prevention
92,109
2025
92,109
2026
92,109
education. Pre-exposure prophylaxis
(PrEP) has emerged as an effective HIV
prevention strategy for individuals who
are most at risk, and the inclusion of
PrEP in the HIV prevention services
provided at Title X sites is becoming an
increasingly important method for
protecting individuals of all ages from
acquiring HIV.
TABLE D10—ADDITIONAL CLIENTS TESTED FOR SEXUALLY TRANSMITTED INFECTIONS UNDER TITLE X
Year
2022
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Chlamydia ............................................................................
Gonorrhea ............................................................................
Syphilis .................................................................................
Confidential HIV ...................................................................
Positive Test Results ....................................................
Services of the type provided under
Title X likely result in reduced costs to
taxpayers as a result of a reduction in
unintended pregnancies, pre-term and
low-birthweight births, sexually
transmitted infections, infertility, and
cervical cancer. This report 49 estimates
that each dollar spent on these services
results in a net Government saving of
$7.09. We do not replicate the
calculations, but note that they are
derived from cost savings associated
with averting unintended pregnancy
and complications such as pre-term and
low birth-weight births. These cost
savings are also derived from detecting
and treating sexually transmitted
infections that would have resulted in
more serious outcomes, including
infertility, cancer, and death.
In addition to the effects described
above, this proposed rule would also
enhance the equity and dignity
associated with access to family
planning services provided by Title X.
A recent research brief summarized
interviews with 30 women sharing their
experiences with contraceptive access,
providing suggestive evidence that birth
control has an important positive
impact on women’s lives. Interviewees
noted that birth control allowed women
to ‘‘to pursue academic and professional
49 Jennifer J. Frost, Adam Sonfield, Mia R. Zolna,
and Lawrence B. Finer (2014). ‘‘Return on
Investment: A fuller assessment of the benefits and
costs of the US publicly funded family planning
program’’ Milbank Quarterly 2014 Dec;92(4):696–
749.
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2023
371,014
416,037
157,199
227,774
873
742,029
832,074
314,397
455,547
1,745
goals, achieve financial stability, and
maintain their mental and physical
health.’’ 50 These recent interviews are
consistent with the historical experience
of the importance of birth control. For
example, one econometric study
identifies a causal relationship between
the introduction and diffusion of the
birth control pill and the increase in
women enrolling in professional degree
programs and increasing the age at first
marriage.51 Title X services help
connect women with the free
contraception provided by the
Affordable Care Act, which allows them
to experience these and other positive
outcomes associated with access to
contraception.
Researchers have identified other
economic, social, and health impacts of
increased access to family planning,
contraception, and treatment. For
example, Bailey et al. (2019) finds ‘‘that
children born after the introduction of
Federal family planning programs were
7 percent less likely to live in poverty
and 12 percent less likely to live in
households receiving public
assistance.’’ They perform an additional
bounding analysis, which suggests that
50 Rebecca Peters, Sarah Benetar, Brigette Courtot,
and Sophia Yin (2019). ‘‘Birth Control is
Transformative.’’ Urban Institute. https://
www.urban.org/sites/default/files/publication/
99912/birth_control_is_transformative_1.pdf.
Accessed April 6, 2021.
51 Goldin, Claudia and Lawrence F. Katz (2002).
‘‘The power of the pill: Oral contraceptives and
women’s career and marriage decisions.’’ Journal of
Political Economy 110(4): 730–770.
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742,029
832,074
314,397
455,547
1,745
2025
742,029
832,074
314,397
455,547
1,745
2026
742,029
832,074
314,397
455,547
1,745
about two thirds of the estimated gains
are due to increases in the incomes of
parents.52 A recent summary discusses
other impacts of access to family
planning services in the United States
and in other countries, which extends
beyond women and girls, to their
children and wider communities.53
The calculations above represent
observable metrics of the effect of the
Title X program, which is important for
evaluating the direct effect of the
program. For this reason, the scope of
our analysis initially focuses on clients
served and services provided by Title X
facilities. To properly account for the
net effect of the proposed rule when
comparing the baseline scenario to the
policy scenario, we would need to
assess the extent to which clients and
services continue to be provided
through other channels than Title X
funded sites without the proposed rule.
As a general matter, the impacts of this
proposed rule may include:
• Transfers between grantees and
would-be grantees within the Title X
program;
• other transfers (for example, if Title
X newly funds medical services that
would, in the absence of the proposed
rule, be provided by charitable
52 Bailey, Martha J., Olga Malkova, Zoe
¨ M.
McLaren (2019). ‘‘Does Access to Family Planning
Increase Children’s Opportunities? Evidence from
the War on Poverty and the Early Years of Title X.’’
Journal of Human Resources 54:4 pp. 825–856.
doi:10.3368/jhr.54.4.1216–8401R1.
53 Emily Sohn (2020). ‘‘Strengthening society
with contraception.’’ Nature 588, S162–S164.
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organizations or other private payers);
and
• societal benefits and costs to the
extent that the volume or characteristics
(such as location, which determines
travel costs) of medical services would
differ with and without the proposed
rule.
As noted earlier in this preamble, all
Planned Parenthood affiliates—which,
in 2015, served 41 percent of all
contraceptive clients at Title X-funded
service sites—withdrew from Title X
due to the 2019 Final Rule. However, a
comparison of Planned Parenthood’s
two most recent annual financial reports
indicates no subsequent decrease in the
number of patients served and an
increase, from 9.8 million to 10.4
million, in the number of services
provided per annum (pre-pandemic).54
Although such year-to-year comparisons
are simplistic and a focus on just one
organization (even a prominent one,
with extensive activities) has obvious
limitations, this evidence may suggest
that the Title X program impacts
quantified elsewhere in this regulatory
impact analysis may largely be
associated with transfers. Although
there are notable challenges with
quantifying the benefit, cost and transfer
impacts of the proposed rule, we request
comment that might facilitate
refinement of the analysis prior to
regulatory finalization.
e. Further Discussion of Distributional
Effects
The Title X program is designed to
provide services with priority given to
persons from low-income families.
According to the most recent data, 64%
of clients have income under 101% of
the Federal poverty level; 14% between
101% and 150%; 7% between 151% to
200%; 3% between 201% and 250%;
7% over 250%; and 5% have an
unknown or unreported income level.
Among program clients, 33% are
Hispanic or Latino of all races; 3% are
Asian and Not Hispanic or Latino; 22%
are Black or African American and Not
Hispanic or Latino; 32% are White and
Not Hispanic or Latino; and 5% are
Other or Unknown and Not Hispanic or
Latino; and 4% are Unknown or not
Reported. Furthermore, the Title X
statutory directive requires Title X
projects to provide services for
adolescents without required parental
consent. This makes Title X a critical
source of sexual and reproductive
healthcare for young people. In 2019,
2% program clients were younger than
15, and 8% were younger than 18.
Additional information about the
number and distribution of all family
planning clients by age and year are
available in Exhibit A–3a of the 2019
Title X Annual Report. The benefits of
revoking the 2019 Final Rule would
likely accrue roughly in proportion with
these income and race and ethnicity
figures. The costs of revoking the 2019
Final Rule would likely accrue
proportional to the income and other
demographics of the general public.
This proposed rule would also likely
have important geographic effects. As
described in greater detail in the
Baseline Section, 6 States currently have
no Title X services, and 6 additional
states have limited Title X services. This
proposed rule would likely result in
restoration of services to individuals in
these States.
f. Uncertainty and Sensitivity Analysis
All of the major drivers of the
quantified effects of this analysis are
dependent on our forecast of the
baseline number of clients served. We
acknowledge the uncertainty in this
baseline and have performed a
sensitivity analysis to quantify its
importance. For our primary baseline,
we chose 2.5 million annual clients of
Title X services, which corresponds to
the number of clients in fiscal year 2019
among remaining grantees. As a
sensitivity analysis, we investigate the
effect of the proposed rule compared to
a baseline with 1.5 million clients,
corresponding to preliminary estimates
for fiscal year 2020. For comparison, we
also looked at the effects using an upper
bound of 3.1 million clients served,
which is the reported figure for 2019,
but which includes 19 grantees, 231
subrecipients, and 945 service sites that
withdraw from the Title X program
following the 2019 Final Rule.
Table F1 presents the number of
clients served under different
assumptions of the baseline. We also
recalculate the number of clients served
for the proposed rule scenario for each
of the baseline assumptions. Since the
number of clients served in the first year
is the midpoint between the baseline
and long-run equilibrium figure, the
number of clients served in fiscal year
2022 under the proposed rule would be
lower for the lower-bound scenario than
the primary baseline. Similarly, the
number of clients served under the
proposed rule would be higher in the
upper-bound scenario.
TABLE F1—TITLE X CLIENTS SERVED UNDER DIFFERENT BASELINE ASSUMPTIONS
Year
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2022
2023
2024
2025
2026
Baseline
.........................................................
.........................................................
.........................................................
.........................................................
.........................................................
Baseline, LB
2,512,066
2,512,066
2,512,066
2,512,066
2,512,066
Baseline, UB
1,536,744
1,536,744
1,536,744
1,536,744
1,536,744
3,095,666
3,095,666
3,095,666
3,095,666
3,095,666
Proposed rule
Proposed rule,
LB
Proposed rule,
UB
3,247,958
3,983,849
3,983,849
3,983,849
3,983,849
2,760,297
3,983,849
3,983,849
3,983,849
3,983,849
3,539,758
3,983,849
3,983,849
3,983,849
3,983,849
Table F2 calculates the effect of the
proposed rule under different baseline
assumptions. These estimates are
reported by year, as well as in present
value and annualized for the 5-year time
horizon of our analysis, applying a 3%
and a 7% discount rate. Under the
lower-bound baseline scenario, the
proposed rule would have about a 66%
greater impact on the number of clients
served in annualized terms under the
primary baseline scenario. Under the
upper-bound baseline scenario, the
proposed rule would have about a 64%
lesser impact.
54 Please see https://
www.plannedparenthood.org/uploads/filer_public/
2e/da/2eda3f50-82aa-4ddb-acce-c2854c4ea80b/
2018-2019_annual_report.pdf and https://
www.plannedparenthood.org/uploads/filer_public/
67/30/67305ea1-8da2-4cee-9191-19228c1d6f70/
210219-annual-report-2019-2020-web-final.pdf. The
latter report indicates that Planned Parenthood
conducted a major fundraising campaign with the
2019 Title X regulatory changes as its key
motivating message. If funds are more efficiently
gathered and distributed via a program such as Title
X than through such private campaigns, the
efficiency would represent a cost savings
attributable to the proposed rule.
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TABLE F2—EFFECT OF THE PROPOSED RULE UNDER DIFFERENT BASELINE ASSUMPTIONS
Year
2022 .............................................................................................................................................
2023 .............................................................................................................................................
2024 .............................................................................................................................................
2025 .............................................................................................................................................
2026 .............................................................................................................................................
PDV, 3% ......................................................................................................................................
PDV, 7% ......................................................................................................................................
Annualized, 3% ............................................................................................................................
Annualized, 7% ............................................................................................................................
As discussed earlier, we acknowledge
uncertainty in how quickly the Title X
program will be able to restore service
to levels experienced prior to the drops
associated with the 2019 Final Rule.
Our primary analysis adopts a two-year
phase for grantees, subrecipients,
service sites, and clients served to reach
our long-run equilibrium estimates. If a
large number of service sites have shut
down permanently, the assumption of a
two-year phase in would likely result in
an overestimate of the proposed rule’s
effect over the time horizon of the
analysis. Similarly, if a small number of
service sites have shut down, the
analysis would tend to underestimate
the effect of the proposed rule.
Proposed rule
Proposed rule,
LB
Proposed rule,
UB
735,892
1,471,783
1,471,783
1,471,783
1,471,783
6,025,877
5,346,852
1,315,778
1,304,047
1,223,553
2,447,105
2,447,105
2,447,105
2,447,105
10,019,109
8,890,107
2,187,718
2,168,214
444,092
888,183
888,183
888,183
888,183
3,636,461
3,226,687
794,038
786,959
Therefore, as a second sensitivity
analysis, we present estimates that
adopt alternative assumptions about the
length of time it will take to reach the
long-run equilibrium estimates. Table
F3 presents our primary estimates,
based on a two-year phase in, estimates
without a phase in, and estimates with
a 3-year phase in assumption.
TABLE F3—TITLE X CLIENTS WITH DIFFERENT PHASE-IN ASSUMPTIONS
Year
2022
2023
2024
2025
2026
Baseline
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
Table H4 calculates the effect of the
proposed rule with different phase-in
assumptions. These estimates are
reported by year, as well as in present
value and annualized for the 5-year time
2,512,066
2,512,066
2,512,066
2,512,066
2,512,066
horizon of our analysis, applying a 3%
and a 7% discount rate. Compared to
our primary estimates, the assumption
of no phase in yields annualized effects
of the proposed rule that are about 12%
Proposed rule,
2-year
phase in
Proposed rule,
no phase in
Proposed rule,
3-year
phase in
3,247,958
3,983,849
3,983,849
3,983,849
3,983,849
3,983,849
3,983,849
3,983,849
3,983,849
3,983,849
3,002,660
3,493,255
3,983,849
3,983,849
3,983,849
higher. Assuming a 3-year phase in
yields annualized effects that are about
12% lower than the primary estimates.
TABLE F4—EFFECT OF THE PROPOSED RULE WITH DIFFERENT PHASE-IN ASSUMPTIONS
Year
2022 .............................................................................................................................................
2023 .............................................................................................................................................
2024 .............................................................................................................................................
2025 .............................................................................................................................................
2026 .............................................................................................................................................
PDV, 3% ......................................................................................................................................
PDV, 7% ......................................................................................................................................
Annualized, 3% ............................................................................................................................
Annualized, 7% ............................................................................................................................
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g. Analysis of Regulatory Alternatives to
the Proposed Rule
We analyzed two alternatives to the
approach under the proposed rule. We
considered one option to maintain many
elements of the 2019 Final Rule and to
impose additional restrictions on
grantees. This approach would
exacerbate the trends of reduced Title X
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grantees, subrecipients, service sites,
and clients served that we have
observed under the 2019 Final Rule.
Second, we considered revising the
2019 Final Rule by readopting many
elements of the 2000 regulations, but
adopting additional flexibilities for
grantees and reducing programmatic
oversight. However, our experience
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Proposed rule,
2-year
phase in
Proposed rule,
no phase in
Proposed rule,
3-year
phase in
735,892
1,471,783
1,471,783
1,471,783
1,471,783
6,025,877
5,346,852
1,315,778
1,304,047
1,471,783
1,471,783
1,471,783
1,471,783
1,471,783
6,740,335
6,034,601
1,471,783
1,471,783
490,594
981,189
1,471,783
1,471,783
1,471,783
5,325,293
4,689,098
1,162,802
1,143,627
suggests the compliance regime as it
existed prior to the 2019 Final Rule was
effective.
VI. Environmental Impact
We have determined under 21 CFR
25.30(k) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
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environmental assessment nor an
environmental impact statement is
required.
VII. 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 1.
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.
• 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 § 59.5 (What
requirements must be met by a family
planning project?) and § 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?).
Proposed § 59.4 would require Title X
grant applicants to describe how the
proposed project would satisfy the
regulatory requirements for the Title X
program in their applications. All other
reporting burden associated with grant
applications is already approved via
existing Grants.gov common forms.
Proposed § 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
description of the extent of
collaboration and a clear explanation of
how the grantee would ensure adequate
oversight and accountability.
Proposed § 59.5 would also 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
§ 59.5, and make continuation of
funding for Title X services contingent
upon demonstrating to the Secretary
that the criteria have been met.
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 1 hour 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 1060,
based on 2019 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 $69.86 per hour for the
lawyer and $55.37 per hour for the
medical and health service manager.
The labor cost is $132,750 in the first
year (($69.86 × 1 + $55.37 × 1) × 1060
grantees and subrecipients). We
estimate that the cost, in subsequent
years, would be $95,700 which would
represent an annual allotment of 30
minutes for the lawyer and one hour for
the medical and health service manager
(($69.86 × 0.5 + $55.37 × 1) × 1060
grantees and subrecipients).
The Department estimates that all
recipients and subrecipients will review
their organizational policies and
procedures or take other actions to selfassess 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 2 hours and a medical and
health service manager spending an
average of 2 hours. The labor cost for
self-assessing compliance, such as
reviewing policies and procedures, is a
total of $265,500 each year (($69.86 × 2
+ $55.37 × 2) × 1060 grantees and
subrecipients).
The burden for the documentation of
compliance is the cost of grantee and/
or subrecipient staff time to (a) complete
reports regarding information related to
subrecipients, referral agencies and
individuals involved in the grantee’s
Title X project.
The labor cost would include a
medical and health services manager
spending an average of two 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 $117,400 each year
($55.37 × 2 hours × 1060 grantees and
subrecipients).
TABLE 1—PROPOSED ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS OR BURDEN OF RESPONSE IN YEAR
ONE/SUBSEQUENT YEARS FOLLOWING PUBLICATION OF THE FINAL RULE
OMB control
No.
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Regulation burden
Respondents
responses
Hourly rate
($)
Burden per
response
(hours)
Total annual
burden
(hours)
Assurance of Compliance ........................
0938-New
1060/1060
62.62/62.62
6/5.44
6360/5766
Documentation of Compliance .................
0938-New
1060/1060
55.37/55.37
2/2
2120/2120
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Labor cost of
reporting
($)
398,250/
361,200
117,400/
117,400
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19829
TABLE 1—PROPOSED ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS OR BURDEN OF RESPONSE IN YEAR
ONE/SUBSEQUENT YEARS FOLLOWING PUBLICATION OF THE FINAL RULE—Continued
OMB control
No.
Respondents
responses
Hourly rate
($)
Burden per
response
(hours)
Total annual
burden
(hours)
........................
........................
........................
........................
........................
Regulation burden
Total cost ..........................................
Labor cost of
reporting
($)
516,650/
478,600
Note: 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
Birth control, Contraception, Family
planning, Grant programs, Health
facilities, Title X.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
PART 59—GRANTS FOR FAMILY
PLANNING
For the reasons set out in the
preamble, subpart A of part 59 of title
42, Code of Federal Regulations, is
hereby proposed to be revised to read as
follows:
Subpart A—Project Grants for Family
Planning Services
Sec.
59.1 To what programs do the regulations
in this subpart apply?
59.2 Definitions.
59.3 Who is eligible to apply for a family
planning services grant?
59.4 How does one apply for a family
planning services grant?
59.5 What requirements must be met by a
family planning project?
59.6 What procedures apply to assure the
suitability of informational and
educational material?
59.7 What criteria will the Department of
Health and Human Services use to
decide which family planning services
projects to fund and in what amount?
59.8 How is a grant awarded?
59.9 For what purposes may grant funds be
used?
59.10 Confidentiality.
59.11 Additional conditions.
59.12 What other HHS regulations apply to
grants under this subpart?
Subpart A—Project Grants for Family
Planning Services
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Authority: 42 U.S.C. 300a–4.
§ 59.1 To what programs do the
regulations in this subpart apply?
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. 3200) to assist in
the establishment and operation of
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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.
§ 59.2
Definitions.
As used in this subpart:
Act means the Public Health Service
Act, as amended.
Adolescent-friendly health services
are services that are accessible,
acceptable, equitable, appropriate and
effective for adolescents.
Client-centered care is respectful of,
and responsive to, individual client
preferences, needs, and values; client
values guide all clinical decisions.
Culturally and linguistically
appropriate services are respectful of
and responsive to the health beliefs,
practices and needs of diverse patients.
Family means a social unit composed
of one person, or two or more persons
living together, as a household.
Family planning services include a
broad range of medically approved
contraceptive services, which includes
Food and Drug Administration (FDA)approved contraceptive services and
natural family planning methods, for
clients who want to prevent pregnancy
and space births, pregnancy testing and
counseling, assistance to achieve
pregnancy, basic infertility services,
sexually transmitted infection (STI)
services, and other preconception health
services.
Health equity is when every person
has the opportunity to attain their full
health potential and no one is
disadvantaged from achieving this
potential because of social position or
other socially determined
circumstances.
Inclusivity ensures that all people are
fully included and can actively
participate in and benefit from family
planning, including, but not limited to,
individuals who belong to underserved
communities, such as Black, Latino, and
Indigenous and Native American
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persons, Asian Americans and Pacific
Islanders and other persons of color;
members of religious minorities;
lesbian, gay, bisexual, transgender, and
queer (LGBTQ+) persons; persons with
disabilities; persons who live in rural
areas; and persons otherwise adversely
affected by persistent poverty or
inequality.
Low-income family means a family
whose total annual 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 family 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, unemancipated
minors who wish to receive services on
a confidential basis must be considered
on the basis of their own resources.
Nonprofit, as applied to any private
agency, institution, or organization,
means that no part of the entity’s net
earnings benefit, or may lawfully
benefit, any private shareholder or
individual.
Quality healthcare is safe, effective,
client-centered, timely, efficient, and
equitable.
Secretary means the Secretary of
Health and Human Services and any
other officer or employee of the
Department of Health and Human
Services to whom the authority
involved has been delegated.
Service site is a clinic or other
location where Title X services (under
the Act) are provided to clients. Title X
recipients and/or their subrecipients
may have service sites.
State includes, in addition to the
several States, the District of Columbia,
Guam, the Commonwealth of Puerto
Rico, the Northern Mariana Islands, the
U.S. Virgin Islands, American Samoa,
the U.S. Outlaying Islands (Midway,
Wage, et al.), the Marshall Islands, the
Federated State of Micronesia and the
Republic of Palau.
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Trauma-informed means a program,
organization, or system that is traumainformed realizes the widespread
impact of trauma and understands
potential paths for recovery; recognizes
the signs and symptoms of trauma in
clients, families, staff, and others
involved with the system; and responds
by fully integrating knowledge about
trauma into policies, procedures, and
practices, and seeks to actively resist retraumatization.
§ 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.
§ 59.4 How does one apply for a family
planning services grant?
(a) Application for a grant under this
subpart shall be made on an authorized
form.
(b) An individual authorized to act for
the applicant and to assume on behalf
of the applicant the obligations imposed
by the terms and conditions of the grant,
including the regulations of this
subpart, must sign the application.
(c) The application shall contain—
(1) A description, satisfactory to the
Secretary, of the project and how it will
meet the requirements of this subpart;
(2) A budget and justification of the
amount of grant funds requested;
(3) A description of the standards and
qualifications which will be required for
all personnel and for all facilities to be
used by the project; and
(4) Such other pertinent information
as the Secretary may require.
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§ 59.5 What requirements must be met by
a family planning project?
(a) Each project supported under this
part must:
(1) Provide a broad range of
acceptable and effective medically
approved family planning methods
(including natural family planning
methods) and services (including
pregnancy testing and counseling,
assistance to achieve pregnancy, basic
infertility services, STI services,
preconception health services, and
adolescent-friendly health services). If
an organization offers only a single
method of family planning, it may
participate as part of a project as long
as the entire project offers a broad range
of acceptable and effective medically
approved family planning methods and
services. Title X service sites that are
unable to provide clients with access to
a broad range of acceptable and effective
medically approved family planning
methods and services, must be able to
provide a referral to the client’s method
of choice and the referral must not
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unduly limit the client’s access to their
method of choice.
(2) Provide services without
subjecting individuals to any coercion
to accept services or to employ or not
to employ any particular methods of
family planning. Acceptance of services
must be solely on a voluntary basis and
may not be made a prerequisite to
eligibility for, or receipt of, any other
services, assistance from or
participation in any other program of
the applicant.1
(3) Provide services in a manner that
is client-centered, culturally and
linguistically appropriate, inclusive,
and trauma-informed; protects the
dignity of the individual; and ensures
equitable and quality service delivery
consistent with nationally recognized
standards of care.
(4) Provide services without regard of
religion, race, color, national origin,
disability, age, sex, number of
pregnancies, or marital status.
(5) Not provide abortion as a method
of family planning. A project must:
(i) Offer pregnant clients the
opportunity to be provided information
and counseling regarding each of the
following options:
(A) Prenatal care and delivery;
(B) Infant care, foster care, or
adoption; and
(C) Pregnancy termination.
(ii) If requested to provide such
information and counseling, provide
neutral, factual information and
nondirective counseling on each of the
options, and referral upon request,
except with respect to any option(s)
about which the pregnant client
indicates they do not wish to receive
such information and counseling.
(6) Provide that priority in the
provision of services will be given to
clients from low-income families.
(7) Provide that no charge will be
made for services provided to any
clients from a low-income family except
to the extent that payment will be made
by a third party (including a
Government agency) which is
authorized to or is under legal
obligation to pay this charge.
1 42 U.S.C. 300a–8 (Section 205 of Pub. L. 94–63)
states: ‘‘Any (1) officer or employee of the United
States, (2) officer or employee of any State, political
subdivision of a State, or any other entity, which
administers or supervises the administration of any
program receiving Federal financial assistance, or
(3) person who receives, under any program
receiving Federal assistance, compensation for
services, who coerces or endeavors to coerce any
person to undergo an abortion or sterilization
procedure by threatening such person with the loss
of, or disqualification for the receipt of, any benefit
or service under a program receiving Federal
financial assistance shall be fined not more than
$1,000 or imprisoned for not more than one year,
or both.’’
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(8) Provide that charges will be made
for services to clients other than those
from low-income families in accordance
with a schedule of discounts based on
ability to pay, except that charges to
persons from families whose annual
income exceeds 250 percent of the
levels set forth in the most recent
Poverty Guidelines issued pursuant to
42 U.S.C. 9902(2) will be made in
accordance with a schedule of fees
designed to recover the reasonable cost
of providing services.
(i) Family income should be assessed
before determining whether copayments
or additional fees are charged.
(ii) With regard to insured clients,
clients whose family income is at or
below 250% Federal poverty line (FPL)
should not pay more (in copayments or
additional fees) than what they would
otherwise pay when the schedule of
discounts is applied.
(9) Take reasonable measures to verify
client income, without burdening
clients from low-income families.
Recipients that have lawful access to
other valid means of income verification
because of the client’s participation in
another program may use those data
rather than re-verify income or rely
solely on clients’ self-report. If a client’s
income cannot be verified after
reasonable attempts to do so, charges are
to be based on the client’s self-reported
income.
(10) If a third party (including a
Government agency) is authorized or
legally obligated to pay for services, all
reasonable efforts must be made to
obtain the third-party payment without
application of any discounts. Where the
cost of services is to be reimbursed
under title XIX, XX, or XXI of the Social
Security Act, a written agreement with
the title XIX, XX, or XXI agency is
required.
(11)(i) Provide that if an application
relates to consolidation of service areas
or health resources or would otherwise
affect the operations of local or regional
entities, the applicant must document
that these entities have been given, to
the maximum feasible extent, an
opportunity to participate in the
development of the application. Local
and regional entities include existing or
potential subrecipients which have
previously provided or propose to
provide family planning services to the
area proposed to be served by the
applicant.
(ii) Provide an opportunity for
maximum participation by existing or
potential subrecipients in the ongoing
policy decision making of the project.
(12) Title X projects shall comply
with all State and local laws requiring
notification or reporting of child abuse,
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child molestation, sexual abuse, rape,
incest, intimate partner violence or
human trafficking (collectively, ‘‘State
notification laws’’). Title X projects
must provide appropriate
documentation or other assurance
satisfactory to the Secretary that it:
(i) Has in place and implements a
plan to comply with State notification
laws.
(ii) Provides 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 for providers with respect
to notification and reporting of child
abuse, child molestation, sexual abuse,
rape, incest, intimate partner violence
and human trafficking; appropriate
interventions, strategies, and referrals to
improve the safety and current situation
of the patient; and compliance with
State notification laws.
(13) Ensure transparency in the
delivery of services by reporting the
following information in grant
applications and all required reports:
(i) Subrecipients and agencies or
individuals providing referral services
and the services to be provided;
(ii) Description of the extent of the
collaboration with subrecipients,
referral agencies, and any individuals
providing referral services, in order to
demonstrate a seamless continuum of
care for clients; and
(iii) Explanation of how the recipient
will ensure adequate oversight and
accountability for quality and
effectiveness of outcomes among
subrecipients.
(b) In addition to the requirements of
paragraph (a) of this section, each
project must meet each of the following
requirements unless the Secretary
determines that the project has
established good cause for its omission.
Each project must:
(1) Provide for medical services
related to family planning (including
consultation by a healthcare provider,
examination, prescription, and
continuing supervision, laboratory
examination, contraceptive supplies)
and necessary referral to other medical
facilities when medically indicated, and
provide for the effective usage of
contraceptive devices and practices.
(2) Provide for social services related
to family planning, including
counseling, referral to and from other
social and medical service agencies, and
any ancillary services which may be
necessary to facilitate clinic attendance.
(3) Provide for opportunities for
community education, participation,
and engagement to:
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(i) Achieve community understanding
of the objectives of the program;
(ii) Inform the community of the
availability of services; and
(iii) Promote continued participation
in the project by diverse persons to
whom family planning services may be
beneficial to ensure access to equitable,
affordable, client-centered, quality
family planning services.
(4) Provide for orientation and inservice training for all project personnel.
(5) Provide services without the
imposition of any durational residency
requirement or requirement that the
patient be referred by a physician.
(6) Provide that family planning
medical services will be performed
under the direction of a physician with
special training or experience in family
planning.
(7) Provide that all services purchased
for project participants will be
authorized by the project director or his
designee on the project staff.
(8) Provide for coordination and use
of referrals and linkages with primary
healthcare providers, other providers of
healthcare services, local health and
welfare departments, hospitals,
voluntary agencies, and health services
projects supported by other Federal
programs, who are in close physical
proximity to the Title X site, when
feasible, in order to promote access to
services and provide a seamless
continuum of care.
(9) Provide that if family planning
services are provided by contract or
other similar arrangements with actual
providers of services, services will be
provided in accordance with a plan
which establishes rates and method of
payment for medical care. These
payments must be made under
agreements with a schedule of rates and
payment procedures maintained by the
recipient. The recipient must be
prepared to substantiate that these rates
are reasonable and necessary.
(10) Provide, to the maximum feasible
extent, an opportunity for participation
in the development, implementation,
and evaluation of the project by persons
broadly representative of all significant
elements of the population to be served,
and by others in the community
knowledgeable about the community’s
needs for family planning services.
§ 59.6 What procedures apply to assure
the suitability of informational and
educational material (print and electronic)?
(a) A grant under this section may be
made only upon assurance satisfactory
to the Secretary that the project shall
provide for the review and approval of
informational and educational materials
(print and electronic) developed or
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19831
made available under the project by an
Advisory Committee prior to their
distribution, to assure that the materials
are suitable for the population or
community to which they are to be
made available and the purposes of Title
X of the Act. The project shall not
disseminate any such materials which
are not approved by the Advisory
Committee.
(b) The Advisory Committee referred
to in paragraph (a) of this section shall
be established as follows:
(1) Size. The Committee shall consist
of no fewer than five members and up
to as many members the recipient
determines, except that this provision
may be waived by the Secretary for good
cause shown.
(2) Composition. The Committee shall
include individuals broadly
representative of the population or
community for which the materials are
intended (in terms of demographic
factors such as race, ethnicity, color,
national origin, disability, sex, sexual
orientation, gender identity, age, marital
status, income, geography, and
including but not limited to individuals
who belong to underserved
communities, such as Black, Latino, and
Indigenous and Native American
persons, Asian Americans and Pacific
Islanders and other persons of color;
members of religious minorities;
lesbian, gay, bisexual, transgender, and
queer (LGBTQ+) persons; persons with
disabilities; persons who live in rural
areas; and persons otherwise adversely
affected by persistent poverty or
inequality).
(3) Function. In reviewing materials,
the Advisory Committee shall:
(i) Consider the educational, cultural,
and diverse backgrounds of individuals
to whom the materials are addressed;
(ii) Consider the standards of the
population or community to be served
with respect to such materials;
(ii) Review the content of the material
to assure that the information is
factually correct, medically accurate,
culturally and linguistically
appropriate, inclusive, and trauma
informed;
(iii) Determine whether the material is
suitable for the population or
community to which is to be made
available; and
(iv) Establish a written record of its
determinations.
§ 59.7 What criteria will the Department of
Health and Human Services use to decide
which family planning services projects to
fund and in what amount?
(a) Within the limits of funds
available for these purposes, the
Secretary may award grants for the
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establishment and operation of those
projects which will in the Department’s
judgment best promote the purposes of
section 1001 of the Act, taking into
account:
(1) The number of clients, and, in
particular, the number of low-income
clients to be served;
(2) The extent to which family
planning services are needed locally;
(3) The ability of the applicant to
advance health equity;
(4) The relative need of the applicant;
(5) The capacity of the applicant to
make rapid and effective use of the
Federal assistance;
(6) The adequacy of the applicant’s
facilities and staff;
(7) The relative availability of nonFederal resources within the community
to be served and the degree to which
those resources are committed to the
project; and
(8) The degree to which the project
plan adequately provides for the
requirements set forth in these
regulations.
(b) The Secretary shall determine the
amount of any award on the basis of his
estimate of the sum necessary for the
performance of the project. No grant
may be made for less than 90 percent of
the project’s costs, as so estimated,
unless the grant is to be made for a
project which was supported, under
section 1001, for less than 90 percent of
its costs in fiscal year 1975. In that case,
the grant shall not be for less than the
percentage of costs covered by the grant
in fiscal year 1975.
(c) No grant may be made for an
amount equal to 100 percent for the
project’s estimated costs.
§ 59.8
How is a grant awarded?
§ 59.10
(a) The notice of grant award specifies
how long Department of Health and
Human Services (HHS) intends to
support the project without requiring
the project to recompete for funds. This
anticipated period will usually be for
three to five years.
(b) Generally the grant will initially be
for one year and subsequent
continuation awards will also be for one
year at a time. A recipient must submit
a separate application to have the
support continued for each subsequent
year. Decisions regarding continuation
awards and the funding level of such
awards will be made after consideration
of such factors as the recipient’s
progress and management practices, and
the availability of funds. In all cases,
continuation awards require a
determination by HHS that continued
funding is in the best interest of the
Government.
(c) Neither the approval of any
application nor the award of any grant
commits or obligates the United States
in any way to make any additional,
supplemental, continuation, or other
award with respect to any approved
application or portion of an approved
application.
§ 59.9 For what purpose may grant funds
be used?
Any funds granted under this subpart
shall be expended solely for the purpose
for which the funds were granted in
accordance with the approved
application and budget, the regulations
of this subpart, the terms and conditions
of the award, and the applicable cost
principles prescribed in 45 CFR part 75.
Confidentiality.
All information as to personal facts
and circumstances obtained by the
project staff about individuals receiving
services must be held confidential and
must 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. Otherwise, information
may be disclosed only in summary,
statistical, or other form which does not
identify particular individuals.
Reasonable efforts to collect charges
without jeopardizing client
confidentiality must be made. Recipient
must inform the client of any potential
for disclosure of their confidential
health information to policyholders
where the policyholder is someone
other than the client.
§ 59.11
Additional conditions.
The Secretary may, with respect to
any grant, impose additional conditions
prior to, at the time of, or during any
award, when in the Department’s
judgment these conditions are necessary
to assure or protect advancement of the
approved program, the interests of
public health, or the proper use of grant
funds.
§ 59.12 What other HHS regulations apply
to grants under this subpart?
Attention is drawn to the following
the HHS regulations which apply to
grants under this subpart. These
include:
TABLE 1 TO § 59.12
37 CFR part 401 ......................................................................
42 CFR part 50, subpart D ......................................................
45 CFR part 16 ........................................................................
45 CFR part 75 ........................................................................
45 CFR part 80 ........................................................................
45 CFR part 84 ........................................................................
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45 CFR part 91 ........................................................................
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Rights to inventions made by nonprofit organizations and small business firms
under Government grants, contracts, and cooperative agreements.
Public Health Service grant appeals procedure.
Procedures of the Departmental Grant Appeals Board.
Uniform Administrative Requirements, Cost Principles, and Audit Requirements
for HHS Awards.
Nondiscrimination under programs receiving Federal assistance through the Department of Health and Human Services effectuation of Title VI of the Civil
Rights Act of 1964.
Nondiscrimination on the basis of handicap in programs and activities receiving
or benefitting from Federal financial assistance.
Equal treatment for faith-based organizations.
Nondiscrimination on the basis of age in HHS programs or activities receiving
Federal financial assistance.
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E:\FR\FM\15APP1.SGM
15APP1
Federal Register / Vol. 86, No. 71 / Thursday, April 15, 2021 / Proposed Rules
[FR Doc. 2021–07762 Filed 4–14–21; 8:45 am]
I. General Information
BILLING CODE 4150–03–P
1. Submitting Classified Business
Information. Do not submit CBI to EPA
website https://www.regulations.gov or
email. Clearly mark the part or all of the
information that you claim to be CBI.
For CBI information in a disk or CD–
ROM that you mail to EPA, mark the
outside of the disk or CD–ROM as CBI,
and then identify electronically within
the disk or CD–ROM the specific
information that is claimed as CBI. In
addition to one complete version of the
comment that includes information
claimed as CBI, a copy of the comment
that does not contain the information
claimed as CBI must be submitted for
inclusion in the public docket.
Information so marked will not be
disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for Preparing Your Comments.
When submitting comments, remember
to:
• Identify the rulemaking by docket
number and other identifying
information (subject heading, Federal
Register date and page number).
• Follow directions—The Agency
may ask you to respond to specific
questions or organize comments by
referencing a Code of Federal
Regulations (CFR) Part or section
number.
• Explain why you agree or disagree,
suggest alternatives, and substitute
language for your requested changes.
• Describe any assumptions and
provide any technical information and/
or data that you used.
• If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
• Provide specific examples to
illustrate your concerns, and suggest
alternatives.
• Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
• Make sure to submit your
comments by the comment period
deadline identified.
3. Instructions: All submissions
received must include the Docket ID No.
for this rulemaking. Comments received
may be posted without change to
https://;www.regulations.gov/, including
any personal information provided. For
detailed instructions on sending
comments and additional information
on the rulemaking process, see the
SUPPLEMENTARY INFORMATION section of
this document. Out of an abundance of
caution for members of the public and
our staff, the EPA Docket Center and
Reading Room are closed to the public,
with limited exceptions, to reduce the
ENVIRONMENTAL PROTECTION
AGENCY
48 CFR Parts 1532 and 1552
[EPA–HQ–OMS–2020–0389; FRL–10021–63–
OMS]
Environmental Protection Agency
Acquisition Regulation (EPAAR);
Electronic Invoicing and the Invoice
Processing Platform (IPP)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is amending an existing
EPAAR clause to further address
electronic invoicing at EPA via the
Invoice Processing Platform (IPP).
DATES: Comments must be received on
or before June 14, 2021.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OMS–2020–0389, at https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Once submitted, comments cannot be
edited or removed from Regulations.gov.
The EPA may publish any comment
received to its public docket. Do not
submit electronically any information
you consider to be Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. The EPA will generally not
consider comments or comment
contents located outside of the primary
submission (i.e. on the web, cloud, or
other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www2.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Thomas Valentino, Policy, Training and
Oversight Division, Acquisition Policy
and Training Branch (3802R),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460; telephone number: (202) 564–
4522; email address: valentino.thomas@
epa.gov.
SUPPLEMENTARY INFORMATION:
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19833
risk of transmitting COVID–19. Our
Docket Center staff will continue to
provide remote customer service via
email, phone, and webform. We
encourage the public to submit
comments via https://
www.regulations.gov/ or email, as there
may be a delay in processing mail and
faxes. Hand deliveries and couriers may
be received by scheduled appointment
only. For further information on EPA
Docket Center services and the current
status, please visit us online at https://
www.epa.gov/dockets. The EPA
continues to carefully and continuously
monitor information from the Centers
for Disease Control and Prevention
(CDC), local area health departments,
and our Federal partners so that we can
respond rapidly as conditions change
regarding COVID–19.
II. Background
The EPA is amending an existing
EPAAR clause to further address
electronic invoicing at EPA via the
Invoice Processing Platform (IPP).
Currently EPA has one clause that
addresses IPP, which is clause
1552.232–70, Submission of Invoices.
Clause 1552.232–70 is written for costreimbursable and time-and-materials
contracts and orders where considerable
supporting documentation is required.
Such documentation is necessary for
those types of contracts and orders but
is not necessary for other contract types,
like firm-fixed-price (FFP). Therefore,
the subject clause is being amended to
include other contract and order types
like FFP, when it is not suitable to use
clause 1552.232–70 in its current form.
III. Proposed Rule
The proposed rule amends EPA
Acquisition Regulation (EPAAR) part
1532, Contract Financing, by amending
§ 1532.908, Contract Clauses. EPAAR
Subpart 1552.2, Texts of Provisions and
Clauses, is amended by modifying
EPAAR § 1552.232–70 and also
changing the clause title, from
Submission of Invoices to Additional
Instructions for Submission of
Electronic Invoices via the Invoice
Processing Platform (IPP).
1. EPAAR § 1532.908 amends the
prescription for use of § 1552.232–70 by
adding a prescription for Alternate 2
use.
2. EPAAR § 1552.232–70, Submission
of Invoices, is changed to Additional
Instructions for Submission of
Electronic Invoices via the Invoice
Processing Platform (IPP), and adds an
Alternate 2.
E:\FR\FM\15APP1.SGM
15APP1
]]>Agencies
[Federal Register Volume 86, Number 71 (Thursday, April 15, 2021)]
[Proposed Rules]
[Pages 19812-19833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07762]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 59
RIN 0937-AA11
Ensuring Access to Equitable, Affordable, Client-Centered,
Quality Family Planning Services
AGENCY: Office of the Secretary, U.S. Department of Health and Human
Services (HHS).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Office of Population Affairs (OPA), in the Office of the
Assistant Secretary for Health, proposes to revise the rules issued on
March 4, 2019, establishing standards for compliance by family planning
services projects authorized by Title X of the Public Health Service
Act. Those rules have undermined the public health of the population
the program is meant to serve. The Department proposes to revise the
2019 rules by readopting the 2000 regulations, with several
modifications needed to strengthen the program and ensure access to
equitable, affordable, client-centered, quality family planning
services for all clients, especially for low-income clients.
DATES: To ensure consideration, comments must be received by May 17,
2021.
ADDRESSES: You may submit comments, identified by Regulatory
Information Number 0937-AA11, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Enter the above docket ID number in the ``Enter Keyword or ID'' field
and click on ``Search.'' On the next web page, click on ``Submit a
Comment'' and follow the instructions.
Mail or Hand Delivery [For paper, disk, or CD-ROM
submissions] to: Attn: Title X Rulemaking, Office of Population
Affairs, Office of the Assistant Secretary for Health, U.S. Department
of Health and Human Services, 200 Independence Avenue SW, Washington,
DC 20201. Comments, including any personally identifiable or
confidential businesses information, received prior to the close of the
comment period will be posted without change to https://www.regulations.gov.
While the Department welcomes comments on any aspect of the
regulations, we particularly welcome comments concerning how the
current regulations have impacted the public's health or how this
proposal to revise them will promote public health and aid in the
program's fundamental mission to offer a broad range of effective
family planning methods with priority given to clients from low-income
families.
FOR FURTHER INFORMATION CONTACT: Alicia Richmond Scott, Office of
Population Affairs, Office of the Assistant Secretary for Health,
Department of Health and Human Services, 200 Independence Avenue SW,
Washington, DC 20201; telephone: 240-453-2800; email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Statutory Background
II. Regulatory and Litigation Background
III. Public Health Impact as a Result of the 2019 Rules and Reason
for This Proposal
IV. Proposed Rules
A. Section 59.2 Definitions
B. Section 59.5 What requirements must be met by a family
planning project?
C. Section 59.6 What procedures apply to ensure the suitability
of informational and educational material?
D. Section 59.7 What criteria will the Department of Health and
Human Services use to decide which family planning services projects
to fund and in what amount?
E. Section 59.10 Confidentiality
F. Section 59.12 What other HHS regulations apply to grants
under this subpart?
V. Regulatory Impact Analyses
A. Introduction
B. Summary of Costs, Benefits, and Transfers
C. Preliminary Economic Analysis of Impacts
a. Background
b. Market Failure or Social Purpose Requiring Federal Regulatory
Action
c. Purpose of the Proposed Rule
d. Baseline Conditions and Impacts Attributable to the Proposed
Rule
e. Further Discussion of Distributional Effects
f. Uncertainty and Sensitivity Analysis
g. Analysis of Regulatory Alternatives to the Proposed Rule
VI. Environmental Impact
VII. Paperwork Reduction Act
I. Statutory Background
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 as
a means of ``making comprehensive voluntary family planning services
readily available to all persons desiring such services.'' \1\ Section
1001 of the Act (42 U.S.C. 300(a)), as amended, authorizes the
Secretary of Health and Human Services ``to make grants to and enter
into contracts with public or nonprofit private entities to assist in
the establishment and operation of voluntary family planning projects
which shall offer a broad range of acceptable and effective family
planning methods and services (including natural family planning
methods, infertility services, and services for adolescents).'' Section
1006 of the Act (42 U.S.C. 300a-4) ensures that priority of services is
given to clients from low-income families and authorizes the Secretary
to promulgate regulations governing the program.
---------------------------------------------------------------------------
\1\ Public Law 91-572 (``The Family Planning Services and
Population Research Act of 1970''), section 2(1).
---------------------------------------------------------------------------
Enacted as part of the original Title X legislation, Section 1008
of the Act (42 U.S.C. 300a-6) directs that ``None of the funds
appropriated under this title shall be used in programs where abortion
is a method of family planning.'' The Conference Report accompanying
the legislation 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
[[Page 19813]]
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.). This requirement has
been reiterated by later Congresses through annual appropriations
provisos that state: ``[A]mounts provided to said [voluntary family
planning] projects under such title shall not be expended for
abortions.'' See, e.g., Consolidated Appropriations Act, 2021, Public
Law 116-260, Div. H, 134 Stat 1182, 1570.
Since 1970 when Title X was first enacted, Congress has amended the
law several times both through changes to the Title X statute itself
and through yearly appropriations riders. For example, in 1975,
Congress amended Title X to include ``natural family planning methods''
as part of the broad range of family planning methods to be offered by
Title X projects.\2\ PHS Act 1001(a) (42 U.S.C. 300(a)). In 1978,
Congress amended Title X to codify HHS past practice by specifically
requiring that Title X projects include ``services for adolescents.''
\3\ PHS Act 1001(a) (42 U.S.C. 300(a)). The Act was again amended in
1981 to provide that ``[t]o the extent practicable, entities which
receive grants or contracts under this subsection shall encourage
family participation in projects under this subsection.'' \4\ PHS Act
sec. 1001(a) (42 U.S.C. 300(a)).
---------------------------------------------------------------------------
\2\ Public Law 94-63.
\3\ Public Law 95-613. The amendment reflected Congress' intent
to place ``a special emphasis on preventing unwanted pregnancies
among sexually active adolescents.'' S. Rep. No 822, 95th Cong, 2d
sess. 24 (1978).
\4\ Omnibus Budget Reconciliation Act of 1981, Public Law 97-35,
sec. 931(b)(1), 95 Stat. 357, 570 (1981).
---------------------------------------------------------------------------
Congress has also imposed additional requirements through annual
appropriations riders. For example, since Fiscal Year (FY) 1996, the
annual Title X appropriation includes the proviso that ``all pregnancy
counseling shall be nondirective.'' \5\ See, e.g., Consolidated
Appropriations Act, 2021, Public Law 116-260, Div. H, 134 Stat 1182,
1570 (2021). Also since FY 1996, the Title X appropriation has directed
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.'' Id. Since FY 1998, 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.'' \6\ See,
e.g., Consolidated Appropriations Act, 2021, Public Law 116-260, Div.
H, sec. 207, 134 Stat. 1182, 1590. 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. And, since FY 1999, in
a separate rider, Congress has required 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.'' \7\ See, e.g., Consolidated Appropriations Act, 2021, Public
Law 116-260, Div. H, sec. 208, 134 Stat. 1182, 1590 (2021).
---------------------------------------------------------------------------
\5\ Omnibus Consolidated Rescissions and Appropriations Act,
1996, Public Law 104-134, Title II, 110 Stat.1321, 1321-221 (1996).
\6\ 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).
\7\ Department of Health and Human Services Appropriations Act,
1999, Public Law 105-277, Title II, sec. 219, 112 Stat. 2681, 2681-
363 (1998).
---------------------------------------------------------------------------
II. Regulatory and Litigation Background
The Department first promulgated regulations for the Title X
program in 1971 but did not directly address section 1008. 36 FR 18465
(Sept. 15, 1971). With experience, the Department interpreted section
1008 to prohibit grantees \8\ from promoting or encouraging abortion as
a method of family planning in any way and to require that Title X
activities be separate and distinct from any abortion activities. 53 FR
2922, 2923 (Feb. 2, 1988) (describing the Department's interpretation
in the early years of the program). In 1981, the Department built upon
this experience and issued guidelines directing grantees to provide
``nondirective counseling'' to pregnant clients ``upon request''
including: (1) Prenatal care and delivery; (2) infant care, foster
care, or adoption; and (3) pregnancy termination. Counseling included
``referral upon request.'' OPA, Program Guidelines for Project Grants
for Family Planning Services at 13 (1981).
---------------------------------------------------------------------------
\8\ For purposes of this notice of proposed rulemaking, the
terms ``grantee'' and ``recipient'' are used interchangeably.
---------------------------------------------------------------------------
In 1988, reacting in large part to a directive from President
Reagan, the Department changed course. 53 FR 2922 (Feb. 2, 1988).
Regulations promulgated then--commonly called the ``gag rule''--
prohibited the discussion of or referral for abortion. The regulations
also required grantees to maintain strict physical and financial
separation between Title X projects and abortion related activities, to
be determined by the ``facts and circumstances'' of each grantee.
Additionally, the regulations prohibited lobbying, education, dues-
paying, or any other activities which could be interpreted to encourage
or promote abortion as a method of family planning.
The 1988 regulations were immediately subject to multiple lawsuits
and ultimately upheld by the Supreme Court in Rust v. Sullivan, 500
U.S. 173 (1991). In Rust, the Supreme Court held that section 1008 was
``ambiguous'' and ``at no time did Congress directly address the issues
of abortion counseling, referral or advocacy.'' Id at 185. The Court
was nearly unanimous on this point. Blackmun dissenting at 207;
O`Connor Dissenting at 223.\9\ Given the lack of clarity regarding
section 1008, the Court deferred to the Secretary's construction of the
statute as ``reasonable'' under Chevron U.S.A. v. NRDC, 467 U.S. 837
(1984).
---------------------------------------------------------------------------
\9\ Justice Stevens, the only Justice to find the Sec. 1008
unambiguous, believed it ``plainly'' foreclosed the Secretary's
regulations. Stevens dissent at 221.
---------------------------------------------------------------------------
The Court also upheld the regulations against constitutional attack
under the Fifth and First Amendments. Following recent precedent, the
Court held that the Government could constitutionally subsidize some
activities over others and that plaintiffs were still free to pursue
abortion related activities and speech ``when they are not acting under
the auspices of the Title X project.'' Id. at 199.
On November 5, 1991, responding to widespread concerns over the
regulation's overreach into the doctor-patient relationship, President
Bush issued a directive to the Department to allow for open
communications between doctors and patients for all aspects of their
medical condition. See Nat'l Family Planning & Reprod. Health Ass'n v.
Sullivan, 979 F.2d 227 (D.C. Cir 1992). However, the Department did not
engage in rulemaking to carry out the directive, as required by the
Administrative Procedure Act. Therefore, the D.C. Court of Appeals
[[Page 19814]]
upheld a lower court injunction prohibiting the directives from taking
effect. Id.
Almost immediately after taking office, President Clinton issued a
memorandum to the Secretary of HHS, directing suspension of the ``gag
rule'' and commencement of new rulemaking regarding the Title X
program. 58 FR 7455 (Feb. 5, 1993). The Department suspended the 1988
regulations and adopted compliance standards predating the 1988 rules
on an interim basis. 58 FR 7462 (Feb. 5, 1993). The Department also
sought comment on adopting as final the rules and guidance in effect
prior to the 1988 rules. 58 FR 7464 (Feb. 5, 1993). In response to this
proposed rulemaking, the Department received 146 comments, and
finalized new Title X rules in July of 2000. 65 FR 41270 (July 3,
2000). On that same day, the Department published interpretations
relating to the statutory requirement that no funds appropriated under
Title X of the Public Health Service Act be used in programs in which
abortion is a method of family planning. 65 FR 41281 (July 3, 2000).
The new rules rescinded the 1988 rules prohibiting counseling and
referral for abortion. They also eliminated the provisions requiring
strict physical and financial separation between Title X projects and
abortion related activities, while still requiring that abortion and
Title X activities are separated by more than ``mere bookkeeping.'' 65
FR 41270, 41271. Section 59.10 concerning lobbying restrictions was
also repealed, while still adhering to long established interpretations
of the statute forbidding promotion of abortion through advocacy
activities. Id. at 41277. Finally, the Department codified the 1981
guidance requiring, upon request of the pregnant patient, nondirective
counseling and referral, regarding any option requested: ``(1) prenatal
care and delivery; (2) infant care, foster care, or adoption; and (3)
pregnancy termination.'' Id. at 41279 [42 CFR 59.5(a)(5) (2000 reg)].
In promulgating the 2000 regulations, the Department concluded that
revoking the 1988 regulations was within its administrative discretion
and that there was no evidence the ``gag rule'' would--or could--work
in practice. The Department concluded experience had taught that the
rules and policies previous to the 1988 regulations had been accepted
by grantees and enabled the program to operate successfully during
virtually its entire history. Additionally, the Department relied on
the direction from Congress in appropriations riders beginning in 1996
(Pub. L. 104-134), requiring that ``all pregnancy counseling be
nondirective,'' believing any referral to a prenatal or other provider
when not requested would raise real questions of coercion. The rule
also incorporated referrals as a ``logical and appropriate outcome'' of
nondirective counseling and consistent with the requirement that the
project provide referrals for any medical services not provided by the
project [42 CFR 59.5(b)(1)]. Id. 41274. For two decades after these
rules were finalized (and nearly three decades after they had been in
place following the 1988 rule's suspension in 1993), Title X faced no
litigation or controversy over these regulations.\10\
---------------------------------------------------------------------------
\10\ As discussed below, the 2000 rule also fully recognized the
statutory conscience right of individual providers to object to
counseling and referral for abortions. Id. At 41274, 41275.
---------------------------------------------------------------------------
In 2018, under a new Administration, the Department proposed new
rules again. 83 FR 25502 (June 1, 2018). These rules largely mirrored
the 1988 regulations and were finalized in 2019. 84 FR 7714 (March 24,
2019). The Department promulgated the 2019 rules because of its stated
view, at that time, that they represented the best interpretation of
the statute and provided the most appropriate guidance for compliance
with the statutory provisions, including section 1008. While pointing
to no direct violations of Title X, associated laws, or the 2000
regulations, the Department believed the 2000 regulations ``fostered an
environment of ambiguity surrounding appropriate Title X activities.''
Id. at 7721. Therefore, ``bright line rules'' would ameliorate any
confusion by grantees and the public.
The Department also cited several conscience protection laws
enacted by Congress to support the changes to the 2000 regulations.
These laws prohibit public health service grantees from requiring
individuals to assist in the performance of health service activities
against their religious beliefs or convictions, 42 U.S.C. 300a-7(d),
and prohibit discrimination against both individual and institutional
providers for their refusal to provide, cover, or refer for abortions.
Consolidated Appropriations Act, 2021, Public Law 116-260, Div. H, sec.
507(d) (2020), Consolidated Appropriations Act, 2021, Public Law 116-
260, Div. H, sec. 507(d) (2020). The Department concluded in 2019 that
the 2000 regulations, if enforced against objecting grantees, would be
inconsistent with these statutory protections and dissuade otherwise
qualified providers from applying for Title X funds.
The 2019 rules also re-imposed the physical separation provisions
of the 1988 rule, as well re-codifying the lobbying restrictions.
Additionally, the rule added requirements on grantees and subrecipients
regarding compliance with state reporting laws, as well as expanded
application and record-keeping requirements. And, with respect to
minors, the 2019 rule required providers to document what specific
actions were taken to encourage family participation.
As to nondirective counseling and referral for abortion, in
recognition of the Congressional direction for nondirective counseling
on abortion in yearly appropriations riders, the 2019 rule allowed, but
did not require, counseling by grantees, limited to physicians and
advanced care providers. Id. at 7744. However, the Department believed
that the abortion referral requirement was inconsistent with section
1008 and that, though permissible for nearly the entire history of the
program, such referrals must be prohibited. Id.
Litigation over the 2019 rule immediately ensued. The Department
was sued by 23 states, every major medical organization, Title X
grantee organizations, and individual grantees. The suits were lodged
in multiple district courts and alleged a variety of claims under the
Administrative Procedure Act, the Affordable Care Act, and the
Constitution. The rule was ultimately upheld by an en banc Court of
Appeals for the Ninth Circuit and enjoined (only as to the state of
Maryland) by a district court in Maryland in a decision upheld by the
en banc Court of Appeals for the Fourth Circuit. Both court of appeals
decisions were issued over substantial dissents.
In California v. Azar, 950 F.3d 1067 (9th Cir. 2020), the Ninth
Circuit relied heavily on Rust in upholding the rule. A majority of the
en banc panel found that the Department ``could'' interpret section
1008 as it did in the 2019 rule, and nothing in subsequent legislation
prevented this reading. Id. at 1085. The Ninth Circuit upheld the rule
against an arbitrary and capricious challenge, stating, ``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.'' Id. at 1097
(emphasis in original). Conversely, a majority of the Fourth Circuit
found the Department's 2019 rule arbitrary and capricious. Mayor of
Baltimore v. Azar, 973 F.3d 258 (4th Cir. 2020). The Fourth Circuit
also held the 2019 rule violated the non-directive mandate.\11\
---------------------------------------------------------------------------
\11\ Both the Ninth and Fourth Circuits also came to opposite
results on the validity of the rule under section 1554 of the
Affordable Care Act [42 U.S.C. 18114].
---------------------------------------------------------------------------
[[Page 19815]]
Losing parties in both cases sought review from the Supreme Court
in October of 2020. The Court granted certiorari on February 22, 2021,
consolidating the cases. No. 20-429. On March 12, 2021, the parties
stipulated to dismiss the cases under Supreme Court Rule 46.1.
III. Public Health Impact as a Result of the 2019 Rules and Reason for
this Proposal
The 2019 rule split courts and judges on its approach, its
reasonableness, and the interpretation of subsequent legislative
provisions. Still, no court questioned the Supreme Court's fundamental
holding in Rust that section 1008 is ``ambiguous.'' And, while section
1008 may be ambiguous, the public health consequences of the previous
Administration's interpretation of the statute are not. The following
outlines the effects of the 2019 rule:
The number of family planning services grantees has
dropped precipitously, resulting in an adverse impact on the number of
clients served. After the implementation of the 2019 Title X Final
Rule, 19 Title X grantees out of 90 total grantees, 231 subrecipients,
and 945 service sites immediately withdrew from the Title X program.
Overall, the Title X program lost more than 1,000 service sites. Those
service sites represented approximately one quarter of all Title X-
funded sites in 2019. Title X services are not currently available at
all in six states (HI, ME, OR, UT, VT, and WA) and are only available
on a very limited basis in six additional states (AK, CT, MA, MN, NH,
and NY). California, the single-largest Title X project in the nation
(before the 2019 Final Rule) had 128, or 36 percent, of its Title X
service sites withdraw from the program, leaving more than 700,000
patients without access to Title X-funded care. Similarly, in New York,
the number of Title X-funded service sites dropped from 174 to just
two, leaving more than 328,000 patients without Title X-funded care.
All Planned Parenthood affiliates--which in 2015 had served 41 percent
of all clients at Title X service sites--withdrew from Title X due to
the 2019 Final Rule.\12\ The withdrawal of numerous grantees,
subrecipients, and service sites adversely impacted the number of
clients served under the Title X program. With the 2019 Final Rule only
being in place for five and a half months, the remaining 71 Title X
grantees served 844,083 fewer clients as compared to the previous year,
prior to the change in the regulations. Specifically, 3,939,749 clients
were served in 2018; 3,095,666 clients were served in 2019, an
approximately 22 percent decrease.\13\
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\12\ (Kaiser Family Foundation, 2020). Current Status of the
Title X Network and the Path Forward.
\13\ (OPA, 2020). Family Planning Annual Report: 2019 National
Summary Report. Accessed on March 9, 2021 from https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf.
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Low-income, uninsured, and racial and ethnic minorities'
access to Title X family planning services has decreased, thereby
contributing to the increase in health inequities and unmet health
needs within these populations. Compared to 2018 Family Planning Annual
Report (FPAR) data prior to the implementation of the 2019 Final Rule,
in 2019, 573,650 fewer clients under 100 percent of the Federal poverty
level (FPL); 139,801 fewer clients between 101 percent to 150 percent
FPL; 65,735 fewer clients between 151 percent and 200 percent FPL; and,
30,194 fewer clients between 201 percent to 250 percent FPL received
Title X services. This contradicts the purpose and intent of the Title
X program, which is to prioritize and increase family planning services
to low-income clients. Additionally, 324,776 fewer uninsured clients
were served in 2019 compared to 2018. FPAR data also demonstrate that
in 2019 compared to 2018, 128,882 fewer African Americans; 50,039 fewer
Asians; 6,724 fewer American Indians/Alaska Natives; 7,218 fewer Native
Hawaiians/Pacific Islanders; and, 269,569 fewer Hispanics/Latinos
received Title X services.\14\
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\14\ (OPA, 2020). Family Planning Annual Report: 2019 National
Summary Report. Accessed on March 9, 2021 from https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf.
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Provision of critical family planning and related
preventive health services has decreased dramatically.\15\ The impact
of the 2019 Final Rule has been devastating to the hundreds of
thousands of Title X clients who have lost access to critical family
planning and related preventive health services due to service delivery
gaps created by the 2019 Final Rule. More specifically, compared to
2018, 225,688 fewer clients received oral contraceptives; 49,803 fewer
clients received hormonal implants; and 86,008 fewer clients received
IUDs. Additionally, 90,386 and 188,920 fewer Papanicolaou (Pap) tests
and clinical breast exams respectively were performed in 2019 compared
to 2018. Confidential human immunodeficiency virus (HIV) tests
decreased by 276,109. Sexually transmitted infection (STI) testing
decreased by 256,523 for chlamydia, by 625,802 for gonorrhea, and by
77,524 for syphilis. Furthermore, 71,145 fewer individuals who were
pregnant or sought pregnancy were served. As a result of the dramatic
decline in Title X services provided, the 2019 Final Rule undermined
the mission of the Title X program by helping fewer individuals in
planning and spacing births, providing fewer preventive health
services, and delivering fewer screenings for STIs. Adolescent services
were also adversely affected. In 2019, 151,375 fewer adolescent clients
received family planning services and 256,523 fewer women under the age
of twenty-five were tested for chlamydia.\16\
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\15\ Ibid.
\16\ (OPA, 2020). Family Planning Annual Report: 2019 National
Summary Report. Accessed on March 9, 2021 from https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf.
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The true impact of the 2019 Final Rule in terms of long-term sexual
and reproductive health negative sequelae in the lives of hundreds of
thousands of low-income clients and clients of color is difficult to
quantify. As a result of the decrease in clients able to receive Title
X services, it is estimated that the 2019 Final Rule may have led to up
to 181,477 unintended pregnancies.\17\
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\17\ Estimating that of the 844,083 fewer clients served by
Title X in 2019 compared to 2018, 21.5% of those clients could have
experienced an unintended pregnancy as a result of not receiving
services. Formula taken from Guttmacher Institute (2017). Unintended
pregnancies prevented by publicly funded family planning services:
Summary of results and estimation formula. Accessed on March 8, 2021
from https://www.guttmacher.org/sites/default/files/pdfs/pubs/Guttmacher-Memo-on-Estimation-of-Unintended-Pregnancies-Prevented-June-2017.pdf.
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Unintended pregnancies increase the risk for poor maternal and
infant outcomes. Individuals having a birth following an unintended
pregnancy are less likely to have benefitted from preconception care,
to have optimal spacing between births, and to have been aware of their
pregnancy early on, which in turn makes it less likely that they would
have received prenatal care early in pregnancy.18 19 The
2019 Final Rule likely also resulted in additional costs to taxpayers
as a result of an increase in unintended pregnancies,
[[Page 19816]]
preterm and low-birthweight births, STIs, infertility, and cervical
cancer.\20\
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\18\ Jessica D. Gipson, Michael A. Koenig, and Michelle J.
Hindin. ``The Effects of Unintended Pregnancy on Infant, Child, and
Parental Health: A Review of the Literature.'' Studies in family
planning 39.1 (2008): 18-38. Web.
\19\ Power to Decide. Maternal and Infant Health and the
Benefits of Birth Control in America. Accessed on March 8, 2020 from
https://powertodecide.org/sites/default/files/resources/supporting-materials/getting-the-facts-straight-chapter-3-maternal-infant-health.pdf.
\20\ Kaiser Family Foundation. https://www.kff.org/womens-health-policy/issue-brief/data-note-impact-of-new-title-x-regulations-on-network-participation/
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OPA has been unable to secure new Title X grantees and
service sites to meet the unmet need for family planning services. To
meet the unmet need for family planning services nationwide, in Fiscal
Year 2019 OPA issued a competitive supplemental funding announcement to
existing grantees. Fifty existing grantees were awarded $33.7 million
to expand Title X services. However, only 7 states (CO, DE, KY, ND, NM,
NV, TX) had a meaningful increase in the number of Title X clinics in
their states.
In addition, OPA has been unable to find new grantees to fill most
of the gaps the 2019 Final Rule created, including in the six states
that lost all Title X-funded services. To address gaps in the Title X
service network and increase coverage, a new competitive funding
announcement was issued in Fiscal Year 2020 to provide services in
unserved or underserved states and communities. The number of
applications received was so low (8 eligible applications received)
that the resulting grant awards were for less than the total amount of
funding available (grant awards for $8.5 million with $20 million
available), and were only able to provide services in three states with
no or limited Title X services at the time. This demonstrated the
negative effects of the 2019 Title X Final Rule on client access to
needed family planning and related preventive health services,
especially for the priority low-income populations that Title X is
mandated to serve.
The realization of a greater pool of grantees, as predicted by the
2019 rule, has not transpired over the course of two grant cycles. As
discussed above, OPA was unable to meaningfully expand services nor was
it able to find new grantees to fill existing gaps. In fact, the 2019
Final Rule did not increase the pool of grantees and was unable to
generate interest in providing Title X services from organizations who
had not previously been Title X grantees. This, coupled with the exodus
of otherwise qualified grantees, subrecipients and service sites that
left the network due to their opposition to the 2019 Final Rule, led to
great difficulty in awarding appropriated funds as intended by
Congress.
The 2019 Final Rule is contrary to the CDC and OPA's
Quality Family Planning (QFP) Guidelines. In April 2014 (with updates
in 2015 and 2017), Providing Quality Family Planning Services:
Recommendations from Centers for Disease Control and Prevention and the
US Office of Population Affairs (QFP),\21\ was published as a CDC
Morbidity and Mortality Weekly Report (MMWR) Recommendations and
Reports. The QFP, developed jointly by the Centers for Disease Control
and Prevention (CDC) and the HHS Office of Population Affairs (OPA),
provides recommendations for use by all reproductive health and primary
care providers with patients who are in need of services related to
preventing or for achieving pregnancy. The QFP are scientific and
evidence-based recommendations that integrate and fill gaps in existing
guidelines for the family planning settings. QFP recommendations are
based on a rigorous, systematic, transparent review of the evidence and
with input from a broad range of clinical experts, OPA, and CDC. The
QFP references numerous other clinical guidelines that are published by
Federal agencies, as well as guidelines released by professional
medical associations.
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\21\ CDC. Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs.
Accessed on March 8, 2021 from https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning.
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These guidelines were developed over a three-year period through
the CDC's Division of Reproductive Health (DRH) and OPA, in
consultation with a wide range of experts and key stakeholders. These
guidelines have been the undisputed standard in reproductive healthcare
ever since. QFP recommendations support all providers in delivering
quality family planning services and define family planning services
within a broader context of preventive services, to improve health
outcomes for women, men, and their (future) children.
The client centered approach adopted in the QFP requires pregnancy
tests to be ``followed by a discussion of options and appropriate
referrals.'' Id. at 14 Further, counseling and referral are to be
provided, ``at the request of the client,'' in accordance with
recommendations from professional medical organizations. Though
formally adopted as a QFP recommendation in 2014, appropriate referrals
with nondirective counseling have been the practice and implicit
standard of care in Title X programs for essentially its entire
history, including in early guidelines and later when expressly
incorporated in the 2000 regulations.
The 2019 rule abandoned this client centered approach over the
objection of every major medical organization without any
countervailing public health rationale. Moreover, the 2019 rule
required prenatal referral even over the objection of the patient. For
the reasons discussed above, that approach cannot be squared with well-
accepted public health principles.
The 2019 Final Rule increased compliance and oversight
costs, with no discernible benefit. The 1988 rules requiring strict
physical and financial separation requirements, were based, in part, on
two governmental reports finding minor compliance issues with grantees
and recommended only more specific guidance, not a substantial
reworking of the regulations. See, e.g., Comp. Gen. Rep. No GAO/HARD-
HRD-82-106 (1982), at 14-15; 65 FR 41270, 41272. While those reports
found some confusion among grantees around section 1008, ``GAO found no
evidence that Title X funds had been used for abortions or to advise
clients to have abortions.'' More importantly, in the decades between
1993 and the 2019 rule, and as evidenced by the silence of the 2019
final rule on this issue, legally required audits, regular site visits,
and other oversight of grantees have found no diversion of grant funds
that would justify the greatly increased compliance and oversight costs
the 2019 rule required.
The 2019 rule's separation requirements also claimed to be
addressing questions of ``fungibility'' and a concern that Title X
funds might be ``intentionally or unintentionally'' co-mingling with
activities not allowed under the statute. 84 FR at 7716. As noted,
close oversight for decades under the 2000 rules uncovered no
misallocation of Title X funds by grantees. Moreover, courts have long
since held that governments cannot restrict access to funds for one
activity simply because it may ``free up'' funds for another activity.
See Planned Parenthood of Cent. & N. Arizona v. Arizona, 718 F.2d 938,
945 (9th Cir 1983) (concluding ``as a matter of law, the freeing-up
theory cannot justify withdrawing all state funds from otherwise
eligible entities merely because they engage in abortion-related
activities disfavored by the state''); see also Agency for Int'l Dev.
v. Alliance for Open Soc'y Int'l, Inc., 570 U.S. 205, 220 (2013)
(``[I]f the Government's argument [that fungibility is sufficient for
prohibition] were correct, League of Women Voters would have come out
differently, and much of the reasoning of Regan and Rust would have
been beside the point''). Because of the 2019
[[Page 19817]]
rule, appropriations that would otherwise be used to carry out the
purposes of the Title X program, providing a broad range of family
planning services to individuals (including confidential services to
minors), are now being diverted to increased infrastructure costs
resulting from the separation requirement as well as the micro-level
monitoring and reporting now required of grantees. None of these
burdensome additional requirements provide discernible compliance
benefits, particularly not to public health. As many commenters and at
least one court emphasized, the 2019 rule was a solution in search of a
problem, a solution whose severe public health consequences caused much
greater problems.
The Department also recognizes Congress has passed several laws
protecting the conscience rights of providers, particularly in the area
of abortion. For example, in promulgating the 2000 Title X rules, the
Department affirmed: ``under 42 U.S.C. 300a-7(d), grantees may not
require individual employees who have such objections [to abortion] to
provide such counseling.'' 65 FR 41270, 41274 (July 3, 2000). Since
2005 Congress has also annually enacted an appropriations rider which
extends non-discrimination protections to other ``health care
entities'' who refuse to counsel or refer for abortion. See, e.g.,
Consolidated Appropriations Act, 2021, Public Law 116-260, Div. H,
section 507(d) (2020). Under these statutes, objecting providers or
Title X grantees are not required to counsel or refer for
abortions.\22\ However, such protections for objecting providers and
grantees should not prohibit willing providers and grantees from
providing information in accordance with the ethical codes of major
medical organizations.
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\22\ This has been the consistent position of the Department
since 2000. See 65 FR at 41274 (in response to comments on
individual objections to providing abortion counseling or referral,
Department stating: ``under 42 U.S.C. 300a-7(d), grantees may not
require individual employees who have such objections to provide
such counseling.'').
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Ultimately, continued enforcement of the 2019 rule raises the
possibility of a two-tiered healthcare system in which those with
insurance and full access to healthcare receive full medical
information and referrals, while low-income populations with fewer
opportunities for care are relegated to inferior access. Given that so
many individuals depend on the Title X program as their primary source
of healthcare, this situation creates a widespread public health
concern. The 2019 rule is not in the best interest of public health.
IV. Proposed Rules
For nearly 50 years without interruption, Title X program grants
have been administered against the backdrop of counseling and referral
for appropriate medical care, including referral for abortion. Family
planning is widely considered one of the most important public health
achievements of the 20th Century.\23\ As the only Federal program
exclusively dedicated to providing contraceptive services, Title X has
been imperative to that success.
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\23\ Centers. for Disease Control & Prevention, Achievements in
Public Health, 1900-1999: Family Planning, 48 Morbidity & Mortality
Weekly Reports No. 47, 1073-80 (Dec. 3, 1999), https://www.cdc.gov/mmwr/preview/mmwrhtml/mm4847a1.htm.
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For five decades, Title X family planning clinics have played a
critical role in ensuring access to a broad range of family planning
and related preventive health services for millions of low-income or
uninsured individuals and others. \24\ Over the 50 years of the Title X
program, Title X clinics have served more than 190 million clients:
182.2 million women, 8.1 million men, comprising 139.5 million adults
and 50.8 million adolescents, across 50 states, the District of
Columbia, and eight U.S. territories and freely associated states.
Title X providers offered clients a broad range of effective and
medically safe contraceptive methods approved by the U.S. Food and Drug
Administration. Title X-funded sexually transmitted infection (STI) and
human immunodeficiency virus (HIV) screening services prevented
transmission and adverse health consequences. Over the 50 years of the
Title X program, Title X clinics also performed 34.1 million chlamydia
tests, 18.3 million HIV tests, 37 million Papanicolaou tests, and 42
million clinical breast exams.
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\24\ OPA. Title X: Celebrating 50 Years of Title X Service
Delivery. Accessed on March 8, 2021 from https://opa.hhs.gov/sites/default/files/2020-11/title-x-50-years-infographic.pdf.
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Given the previous success of the program, the large negative
public health consequences of maintaining the 2019 rules, the
substantial compliance costs for grantees, and the lack of tangible
benefits, the Department proposes revoking the 2019 Title X
regulations. As has been clearly borne out by case law and history, the
Department has the discretion to make this determination and it is in
the interest of public health.
The Department is also concerned that some state policies
restricting eligible subrecipients unnecessarily interfere with
beneficiaries' access to the most accessible and qualified providers.
These state restrictions are not always related to the subrecipients'
ability to effectively deliver Title X services, but rather are
sometimes based either on the non-Title X activities of the providers
or because they are a certain type of provider. However, providers with
a reproductive health focus often provide a broader range of
contraceptive methods on-site and therefore may reduce additional
barriers to accessing services. Moreover, denying participation by
family planning providers that can provide effective services has
resulted in populations in certain geographic areas being left without
Title X providers for an extended period of time.\25\ And, while many
otherwise qualified providers are willing and can provide effective
Title X services, some lack the administrative capacity to directly
apply for and manage a Title X grant.
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\25\ Carter, M.W., Gavin, L., Zapata, L.B., Bornstein, M.,
Mautone-Smith, N., & Moskosky, S.B. (2016). Four aspects of the
scope and quality of family planning services in U.S. publicly
funded health centers: Results from a survey of health center
administrators. Contraception. doi:10.1016/
j.contraception.2016.04.009.
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The Department believes that these state restrictions on
subrecipient eligibility unrelated to the ability to deliver Title X
services undermine the mission of the program to ensure widely
available access to services by the most qualified providers.
Therefore, the Department invites comment on ways in which it can
ensure that Title X projects do not undermine the program's mission by
excluding otherwise qualified providers as subrecipients.
In place of the 2019 Title X regulations, the Department proposes
to largely readopt the 2000 regulations (65 FR 41270) with several
revisions aimed at ensuring access to equitable, affordable, client-
centered, quality family planning services. Advancing equity for all,
including people of color and others who have been historically
underserved, marginalized, and adversely affected by persistent poverty
and inequality, is a priority for OPA and the Title X program. By
focusing on advancing equity in the Title X program, we can create
opportunities for the improvement of communities that have been
historically underserved, which benefits everyone. Additionally, given
the success of the Providing Quality Family Planning Services
guidelines published in 2014,\26\ the Department is
[[Page 19818]]
proposing to incorporate into regulations several of the QFP's
recommendations. Based on experience, the Department is also proposing
some provisions it believes will make the program function more
effectively, efficiently and consistently for all.
---------------------------------------------------------------------------
\26\ CDC. Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs.
Accessed on March 8, 2021 from https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning.
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The Department proposes revising the 2019 Title X Final Rule
through notice and comment rulemaking, by readopting the 2000
regulations with revisions that will enhance the Title X program and
its family planning services, including family planning services
provided using telemedicine, for the future. This will remove the 2019
Final Rule requirements for strict physical and financial separation,
allow Title X providers to provide nondirective options counseling, and
allow Title X providers to refer their patients for all family planning
related services desired by the client, including abortion services. In
addition, this will allow for several revisions that are needed to
strengthen the program and ensure access to equitable, affordable,
client-centered, trauma-informed quality family planning services for
all clients, especially for low-income clients. At the same time, the
proposed rule will retain the longstanding prohibition on directly
promoting or performing abortion that follows from Section 1008's text
and subsequent appropriations enactments. And as indicated above,
individuals and grantees with conscience objections will not be
required to follow the proposed rule's requirements regarding abortion
counseling and referral.
For all the above reasons, the Department proposes to revise the
regulations that govern the Title X family planning services program by
readopting the 2000 regulations (65 FR 41270), with several
modifications. The proposed revisions to the 2000 regulations and
rationale for each are listed below:
A. Section 59.2 Definitions
The Department proposes to revise Sec. 59.2 to include a modified
definition of family planning. The definition of family planning
services included in the 2019 Final Rule did not align with the widely
accepted definition. The definition of family planning services should
be consistent with the Title X statutory requirements and reflect the
widely-recognized definition that is included in Providing Quality
Family Planning Services: Recommendations of CDC and the U.S. Office of
Population Affairs,\27\ which has been used historically by OPA when
implementing the program prior to 2019. Under the proposed regulations,
``family planning services'' are defined as including a broad range of
medically approved contraceptive services, which includes FDA-approved
contraceptive services and natural family planning methods, for clients
who want to prevent pregnancy and space births, pregnancy testing and
counseling, assistance to achieve pregnancy, basic infertility
services, sexually transmitted infection (STI) services, and other
preconception health services.
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\27\ CDC. Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs.
Accessed on March 8, 2021 from https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning.
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The Department also proposes to add definitions for terms used
throughout the revised regulations to provide clarity. The newly
proposed definitions include adolescent-friendly health services,\28\
client-centered care,\29\ health equity,\30\ inclusivity,\31\ quality
\32\ healthcare, service site, and trauma-informed.\33\
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\28\ World Health Organization. Quality Assessment Guidebook. A
guide to assessing health services for adolescent clients. Geneva,
World Health Organization, 2009. Accessed on March 8, 2021 from
https://apps.who.int/iris/handle/10665/44240.
\29\ CDC. Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs.
Accessed on March 8, 2021 from https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning.
\30\ CDC. Health Equity. Accessed on March 12, 2021 from https://www.cdc.gov/chronicdisease/healthequity/index.htm.
\31\ White House. Executive Order on Advancing Racial Equity and
Support for Underserved Communities Through the Federal Government.
Accessed on March 8, 2021 from https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/.
\32\ Institute of Medicine. Crossing the Quality Chasm: A New
Health System for the 21st Century. Accessed on March 8, 2021 from
https://www.ncbi.nlm.nih.gov/books/NBK222274/.
\33\ SAMHSA. SAMHSA's Concept of Trauma and Guidance for a
Trauma-Informed Approach. Accessed on March 8, 2021 from https://ncsacw.samhsa.gov/userfiles/files/SAMHSA_Trauma.pdf.
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The proposed definition for ``service site'' is adapted from
previous Title X Family Planning Guidelines that implemented the 2000
regulations, the 2014 Program Requirements for Title X Funded Family
Planning Projects (hereafter ``2014 Title X Program
Requirements'').\34\ ``Service site'' is defined as a clinic or other
location where Title X services are provided to clients. The Title X
grantees and/or their subrecipients may have services sites. The
proposed definition of service site will assist Title X grantees in
more accurately reporting data on their subrecipient and service sites
and will eliminate confusion in the OPA Title X clinic locator
database.
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\34\ OPA. 2014 Program Requirements for Title X Funded Family
Planning Projects. Accessed on March 8, 2021 from https://www.nationalfamilyplanning.org/document.doc?id=1462.
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All other proposed definitions are used by Federal Government
agencies or major medical associations, and include:
Adolescent-friendly health services are services that are
accessible, acceptable, equitable, appropriate and effective for
adolescents.\35\
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\35\ World Health Organization. Quality Assessment Guidebook. A
guide to assessing health services for adolescent clients. Geneva,
World Health Organization, 2009. Accessed on March 8, 2021 from
https://apps.who.int/iris/handle/10665/44240.
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Client-centered care is respectful of, and responsive to,
individual client preferences, needs, and values; client values guide
all clinical decisions.\36\
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\36\ CDC. Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs.
Accessed on March 8, 2021 from https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning.
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Culturally and linguistically appropriate services are respectful
of and responsive to the health beliefs, practices and needs of diverse
patients.\37\
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\37\ Office of Minority Health. What is Cultural and Linguistic
Competence? Accessed on March 8, 2021 from https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=1&lvlid=6.
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Health equity is achieved when every person has the opportunity to
attain their full health potential and no one is disadvantaged from
achieving this potential because of social position or other socially
determined circumstances.\38\
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\38\ CDC. Health Equity. Accessed on March 12, 2021 from https://www.cdc.gov/chronicdisease/healthequity/index.htm.
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Inclusivity ensures that all people are fully included and can
actively participate in and benefit from family planning, including,
but not limited to, individuals who belong to underserved communities,
such as Black, Latino, and Indigenous and Native American persons,
Asian Americans and Pacific Islanders and other persons of color;
members of religious minorities; lesbian, gay, bisexual, transgender,
and queer (LGBTQ+) persons; persons with disabilities; persons who live
in rural areas; and persons otherwise adversely affected by persistent
poverty or inequality.\39\
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\39\ White House. Executive Order on Advancing Racial Equity and
Support for Underserved Communities Through the Federal Government.
Accessed on March 8, 2021 from https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/.
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[[Page 19819]]
Quality healthcare is safe, effective, client-centered, timely,
efficient, and equitable.\40\
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\40\ Institute of Medicine. Crossing the Quality Chasm: A New
Health System for the 21st Century. Accessed on March 8, 2021 from
https://www.ncbi.nlm.nih.gov/books/NBK222274/.
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Trauma-informed is a program, organization, or system that realizes
the widespread impact of trauma and understands potential paths for
recovery; recognizes the signs and symptoms of trauma in clients,
families, staff, and others involved with the system; and responds by
fully integrating knowledge about trauma into policies, procedures, and
practices, and seeks to actively resist re-traumatization.\41\
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\41\ SAMHSA. SAMHSA's Concept of Trauma and Guidance for a
Trauma-Informed Approach. Accessed on March 8, 2021 from https://ncsacw.samhsa.gov/userfiles/files/SAMHSA_Trauma.pdf.
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The Department also proposes a technical corrections to Sec. 59.2
to replace ``grantee'' with ``recipient'' in the regulatory text to
align with the way the term is used in Federal and HHS regulations.
B. Section 59.5 What requirements must be met by a family planning
project?
The Department proposes revising Sec. 59.5(a)(1) to define what
constitutes a broad range of acceptable and effective family planning
methods and services. The proposed revision revises the 2000
regulations by removing the existing ambiguity and defining what
constitutes a broad range of acceptable and effective family planning
methods and services. The revised definition of the broad range of
methods and services is aligned with the definition used in practice/
policy guidance. Moreover, the same definition is included in CDC and
OPA's Recommendations for Providing Quality Family Planning
Services.\42\ This revision will result in increased equitable access
to a broad range of family planning methods and services to all Title X
clients and more clarity in defining those services.
---------------------------------------------------------------------------
\42\ CDC (2014). Providing Quality Family Planning Services,
Recommendations of CDC and the U.S. Office of Population Affairs.
MMWR, 63(4).
---------------------------------------------------------------------------
The Department proposes revising Sec. 59.5(a)(1) to require
service sites that do not offer a broad range of family planning
methods and services on-site to provide clients with a referral for
where they can access the broad range and ensure, when feasible, that
the referral provided does not unduly limit client access to services,
such as excessive distance or travel time to the referral location or
referral to services that are cost-prohibitive for the client. While an
organization that offers only a single method of family planning may
participate as part of a Title X project as long as the entire project
offers a broad range of family planning services, offering only a
single method of family planning could unduly limit Title X clients,
especially low-income clients, by reducing access to a client's method
of choice. The Department proposes revising the 2000 regulations to
require sites that do not offer the broad range of methods on-site to
be able to provide clients with a referral to a provider who does offer
the client's method of choice. In addition, the referral provided must
be client-centered and not unduly limit access to the client's method
of choice. This revision will help to improve access to client-centered
services.
The Department proposes to revise Sec. 59.5(a)(3) so that family
planning services are required to be client-centered, culturally and
linguistically appropriate, inclusive, trauma-informed, and ensure
equitable and quality service delivery consistent with nationally
recognized standards of care. This revision to the 2000 regulations is
aimed at increasing access and ensuring equity in all services
provided, which is especially important for the Title X program that
prioritizes services for low-income clients. Including within the
regulation a specific focus on services that are client-centered,
culturally and linguistically appropriate, inclusive, trauma-informed,
and ensure equitable and quality service delivery will result in
improved services provided to clients. These new terms are defined in
the proposed regulation under Sec. 59.2, and the added definitions
were derived from existing definitions in use by the Federal Government
or major medical associations.
The Department proposes revising Sec. 59.5(a)(8) to include widely
accepted practices on grant billing practices that were included in
previous Title X Family Planning Guidelines. These revisions
incorporate language that was included in the 2014 Title X Program
Requirements. The 2014 Title X Program Requirements were developed to
assist grantees in understanding and implementing the family planning
services grants. The 2014 Title X Program Requirements described the
various requirements applicable to the Title X program, as set out in
the Title X statute and implementing regulations, and in other
applicable Federal statutes, regulations, and policies. These billing
practices, which are widely accepted in the Title X community, indicate
that: (1) Family income should be assessed before determining whether
copayments or additional fees are charged; and (2) insured clients
whose family income is at or below 250% FPL should not pay more (in
copayments or additional fees) than what they would otherwise pay when
the schedule of discounts is applied. These revisions address areas of
confusion for grantees prior to the 2014 Title X Program Requirements
that were clarified in that document.
The Department proposes adding Sec. 59.5(a)(9) to ensure grantee
income verification policies align with the mission of Title X services
being prioritized for low-income clients. This addition aims to address
an area of common confusion among Title X grantees, which has resulted,
in some instances, in a burden being placed on low-income clients.
First, a requirement is added (using text from the previous 2014 Title
X Program Requirements) to indicate that grantees should take
reasonable measures to verify client income. In addition, a new
requirement is added to use client self-reported income if the income
cannot be verified after reasonable attempts. Without this additional
statement, several Title X grantees have established policies to charge
full price for services following unsuccessful attempts to verify
income, even when the self-reported income is below 250% of the Federal
poverty level (FPL) and would have otherwise qualified for no or
reduced cost services. This proposed revision will greatly improve
accessibility and affordability of services for low-income clients
consistently across all Title X grantees.
The Department proposes adding Sec. 59.5(a)(12) to retain some,
but not all, language from the 2019 Final Rule on notification or
reporting of child abuse, child molestation, sexual abuse, rape,
incest, intimate partner violence or human trafficking. The
notification and reporting requirements are important for Title X
providers as mandatory reporters under state laws and protect Title X
clients. In addition, this regulation formalizes requirements contained
in an annual appropriations rider related to Title X that Congress has
included since FY 1999, requiring 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.''
The Department proposes adding Sec. 59.5(a)(13) to describe
requirements
[[Page 19820]]
related to subrecipient monitoring and reporting. This addition
requires Title X grantees to report on the subrecipients and referral
agencies involved in their Title X projects, and to provide their plan
for oversight and monitoring of their subrecipients in grantee reports.
The regulation no longer requires grantees to report detailed
information about each subrecipient and referral agency such as
location and specific expertise, which will reduce the increased
reporting burden required by the 2019 Final Rule.
The Department proposes revising Sec. 59.5(b)(1) to acknowledge
that consultation for medical services related to family planning can
be provided by healthcare providers beyond the physician. The proposed
revision acknowledges that consultation for healthcare services related
to family planning may be by a physician, but may also be by other
healthcare providers, including physician assistants and nurse
practitioners.
The Department proposes revising Sec. 59.5(b)(3)(iii) to reflect
the desire to engage diverse individuals to make services accessible.
This revision adds language to clarify the intent at engaging diverse
individuals to ensure access to equitable, affordable, client-centered,
quality family planning services.
The Department proposes revising Sec. 59.5(b)(8) to add language
to the existing 2000 regulation text to include primary healthcare
providers in the list of referrals and to state that referrals are to
be to providers in close proximity when feasible to the Title X site in
order to promote access to services and provide a seamless continuum of
care.
The Department also proposes including several technical
corrections to Sec. 59.5. The technical correction proposed in
Sec. Sec. 59.5(a)(4) and 59.6(b)(2) replaces the word ``handicapped
condition'' with ``disability'' in both sections in order to avoid
negative connotations and correct outdated terminology. The technical
correction proposed to Sec. 59.5(a)(5) replaces the word ``women''
with ``client'', and the technical correction proposed to Sec.
59.5(a)(6) and (7) replaces the word ``persons'' with ``clients'' to
use inclusive language. The technical correction proposed to Sec.
59.5(a)(11) replaces the term ``sub-grantees'' with ``subrecipients''.
The technical correction proposed to Sec. 59.5(b)(3) clarifies that
focus of this section is on community education, participation, and
engagement, and should not be confused with the Information and
Education Advisory Committee requirement under Sec. 59.6.
C. Section 59.6 What procedures apply to ensure the suitability of
informational and educational material?
The Department proposes deleting prior Sec. 59.5(a)(11) related to
the Advisory Committee and consolidating with Sec. 59.6; and revising
Sec. 59.6 to clarify intent and remove areas of confusion for grantees
regarding the Advisory Committee and other miscellaneous other
provisions. The 2000 regulations included information about the
Information & Education Advisory Committee in two sections (Sec. Sec.
59.5(a)(11) and 59.6, which was confusing to Title X grantees. The
result is that this revision consolidates all of the Advisory Committee
information in one place, under section Sec. 59.6.
In addition, the Department is proposing several minor revisions to
clarify that the regulation applies to both print and electronic
materials, that the upper limit on council members should be determined
by the grantee, that the factors to be considered for broad
representation on the Advisory Committee match the definition of
inclusivity earlier in the regulation, and that materials will be
reviewed for medical accuracy, cultural and linguistic appropriateness,
and inclusivity and to ensure they are trauma-informed.
D. Section 59.7 What criteria will the Department of Health and Human
Services use to decide which family planning services projects to fund
and in what amount?
The Department proposes enabling the Department to consider the
ability of the applicant to advance health equity when awarding grant
funds. Advancing health equity is critical to the mission of the Title
X program. Adding this additional criterion to the 2000 regulations
brings the total number of criteria from seven to eight.
E. Section 59.8 How is a grant awarded?
The Department proposes a technical correction to revise Sec. 59.8
to change ``project period'' to ``anticipated period'' since HHS is in
the process of adopting revised definition and project period will no
longer be used.
F. Section 59.10 Confidentiality.
The Department proposes revising Sec. 59.10 to include a widely
accepted practice related to client confidentiality. This proposed
revision will add a widely accepted practice in the Title X community
that had been previously included in the 2014 Title X Program
Requirements, indicating that reasonable efforts must be made to
collect charges without jeopardizing client confidentiality. The
Department believes that the Title X program will be strengthened by
including this clarification within the revised 2000 regulations.
In addition, the Department proposes adding a requirement that
grantees must inform the client of any potential for disclosure of
their confidential health information to policyholders where the
policyholder is someone other than the client. Since state and local
laws may vary across jurisdictions (e.g., some are likely to result in
notification to the policyholder that the client has received services,
others provide for an ``opt out'' process whereby the client can elect
that such a notification will not be made), this addition will ensure
that the client understands the implications for using their insurance
and the options available for them to maintain confidentiality.
G. Section 59.11 Additional Conditions
The Department proposes revising Sec. 59.11 to add ``during'' the
period of the award to allow for imposition of additional conditions,
during the period of award in addition to ``prior to and at the time of
any award'', under circumstances where recipient performance or
organizational risk change, e.g. if a recipient is failing to perform
we may impose new conditions mid-award to require corrective action per
45 CFR 75.207.
H. Section 59.12 What other HHS regulations apply to grants under this
subpart?
The Department proposed a technical correction to Sec. 59.12 to
update the regulations that apply to 42 CFR part 59, subpart A. The
proposal includes a reference to 45 CFR part 87 (``Equal Treatment for
Faith-based Organizations'') on the list of regulations that apply to
the Title X family planning services program.
V. Regulatory Impact Analyses
A. Introduction
HHS has examined the impacts of the proposed rule under Executive
Order 12866 on Regulatory Planning and Review, Executive Order 13563 on
Improving Regulation and Regulatory Review, Executive Order 13132 on
Federalism, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders
12866 and 13563 direct HHS to assess all costs and benefits of
available regulatory alternatives and, when regulation is
[[Page 19821]]
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). HHS believes
that this proposed rule is not an economically significant regulatory
action as defined by Executive Order 12866 because it would not result
in annual effects in excess of $100 million.
The Regulatory Flexibility Act requires HHS to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. The proposed rule, if finalized, would lessen administrative
burdens for grantees of all sizes. Therefore, the Secretary certifies
this proposed rule, if finalized, would not have a significant economic
impact on a substantial number of small entities under the Regulatory
Flexibility Act, 5 U.S.C. 605.
Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded
Mandates Act) (2 U.S.C. 1532) requires HHS to 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 $158
million, using the most current (2020) Implicit Price Deflator for the
Gross Domestic Product. This proposed rule would not result in an
expenditure in any year that meets or exceeds this amount.
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. The proposed rule will not have a significant
impact on state funds as, by law, project grants must be funded with at
least 90 percent Federal funds. 42 U.S.C. 300a-4(a). The Department has
determined that this proposed rule does not impose such costs or have
any federalism implications. The Department expects that while some
states may not support the policies contained in this proposed rule,
many states and local health departments will support the policies
contained in this proposed rule, and that it will increase
participation by states (many of who dropped out under the 2019 rule).
B. Summary of Costs, Benefits and Transfers
This proposed rule would revise the 2019 Final Rule by readopting
the 2000 regulations, with several modifications, and returning the
program to the compliance regime as it existed prior to the 2019 rule's
implementation. The proposed approach would allow the Title X program
grantees, subrecipients, and service sites to have a greater impact on
public health than under the current regulatory approach.
We predict that this proposed rule would increase the number of
grantees receiving Title X funds. In turn, the additional service sites
supported by funding would result in additional clients served under
the program. These clients receive access to contraception, public
health screening including clinical breast exams and Papanicolau (Pap)
testing, and testing for sexually transmitted infections. These
services result in a reduction in unintended pregnancy, earlier
detection of breast and cervical cancer, and earlier detection of
sexually transmitted infections including chlamydia, gonorrhea,
syphilis, and human immunodeficiency virus (HIV). This screening and
testing can result in significant cost savings from earlier treatment
and other interventions. This proposed rule would also increase the
diversity of grantees receiving funds, including geographic diversity
to states that do not currently have a Title X grantee.
The proposed rule would also focus grantees on providing services
in a manner that is client-centered, culturally and linguistically
appropriate, inclusive, and trauma-informed; protects the dignity of
the individual; and ensures equitable and quality service delivery.
This focus is especially important for the Title X program that
prioritizes services for low-income clients.
This regulatory impact analysis reports the activity occurring at
Title X funded sites to provide policymakers with this information.
However, the direct impact within the program does not account for
services that continue to be provided at sites not receiving Title X
funding, filling the gap left by providers that withdrew from the
program following the restrictions placed on funding included in the
2019 Final Rule.
C. Preliminary Economic Analysis of Impacts
a. Background
The Title X National Family Planning Program, administered by the
U.S. Department of Health and Human Services (HHS), Office of
Population Affairs (OPA), is the only Federal program dedicated solely
to supporting the delivery of family planning and related preventive
healthcare. The program is designed to provide ``a broad range of
acceptable and effective family planning methods and services
(including natural family planning methods, infertility services, and
services for adolescents)'' with priority given to persons from low-
income families. In addition to offering these methods and services on
a voluntary and confidential basis, Title X-funded service sites
provide contraceptive education and counseling; breast and cervical
cancer screening; sexually transmitted infections (STIs) and HIV
testing, referral, and prevention education; and pregnancy diagnosis
and counseling. The program is implemented through competitively
awarded grants to state and local public health departments and family
planning, community health, and other private nonprofit agencies. In
fiscal year 2021, the Title X program received approximately $286.5
million in discretionary Federal Title X funding.
On March 4, 2019, HHS published a final rule to ``prohibit family
planning projects from using Title X funds to encourage, promote,
provide, refer for, or advocate for abortion as a method of family
planning; require assurances of compliance; eliminate the requirement
that Title X projects provide abortion counseling and referral; require
physical and financial separation of Title X activities from those
which are prohibited under section 1008; provide clarification on the
appropriate use of funds in regard to the building of infrastructure,
and require additional reporting burden from grantees.''
b. Market Failure or Social Purpose Requiring Federal Regulatory Action
The regulatory impact analysis associated with the 2019 Final Rule
predicted that the additional restrictions on grantees would result in
``an expanded number of entities interested in participating in Title
X.'' Further, the analysis suggested the 2019 Final Rule would result
in ``enhanced patient service and care.'' Contrary to these
predictions, during the initial period of the 2019 Final Rule's
implementation, the policy appears to have had the opposite effect. As
we describe in greater detail in the Baseline Section, the restrictions
included in the 2019 Final Rule are associated with a substantial
reduction in the number of Title X grantees, subrecipients, and service
sites, resulting in a
[[Page 19822]]
corresponding reduction in total clients served. This is particularly
troubling, since the Title X program serves a low-income population
that is particularly vulnerable to losing access to these services.
This proposed rule is needed to improve the functioning of Government
and the effectiveness of the Title X program.
c. Purpose of the Proposed Rule
This proposed rule would revise the regulations that govern the
Title X family planning services program by revoking the 2019 Final
Rule and readopting the 2000 regulations with several modifications.
The proposed approach would allow the Title X program grantees,
subrecipients, and service sites to have a greater impact on public
health than under the current regulatory approach.
d. Baseline Conditions and Impacts Attributable to the Proposed Rule
We adopt a baseline that assumes the requirements of the 2019 Final
Rule remain in place over the period of our analysis. To characterize
the real-world impact of the Title X program under this regulatory
approach, we develop an annual forecast of grantees, subrecipients,
service sites, and total clients served. The key inputs to our forecast
are historical data on Title X service grantees. For fiscal years 2016-
2019, this information is summarized in the 2019 Title X Family
Planning Annual Report. We supplement this information with unpublished
preliminary estimates of the impact for fiscal year 2020. Table D1
summarizes these data.
Table D1--Title X Service Grantees
----------------------------------------------------------------------------------------------------------------
Year 2016 2017 2018 2019 2020
----------------------------------------------------------------------------------------------------------------
Grantees........................ 91 89 99 100 73
Subrecipients................... 1,117 1,091 1,128 1,060 803
Service Sites................... 3,898 3,858 3,954 3,825 2,682
Clients Served.................. 4,007,552 4,004,246 3,939,749 3,095,666 1,536,744
----------------------------------------------------------------------------------------------------------------
Source: Title X Family Planning Annual Report, 2019: Exhibit A-2a, and unpublished preliminary estimates for
FY2020.
The data for fiscal years 2016-2019 included all grantees,
subrecipients, and service sites operating at any time during the year.
The adoption of the 2019 Title X Final Rule occurred mid-year in 2019.
Following this regulation, 19 grantees, 231 subrecipients, and 945
service sites withdrew from the Title X program. The reduced number of
grantees, subrecipients, services sites, and clients served observed in
2019 and 2020 cannot be explained by a reduction in discretionary
funding for the program, which has remained constant at $286.5 million
throughout this time period. Since the 2019 figure includes clients
served by these service sites for about half of the year, adopting 3.1
million clients served as an annual forecast would likely overstate
activity in the program under the current regulations. Indeed,
preliminary figures for FY2020 indicate that only about 1.5 million
clients were served. However, this figure likely represents an
underestimate for a typical year of the program under the current
regulations since services were likely disrupted by the ongoing public
health emergency.
As our primary estimate, we adopt 2,512,066 clients served as the
baseline annual impact of Title X under the policies of the 2019 Final
Rule. This 2.5 million corresponds to the number of clients served in
2019 among remaining grantees as of March 2021. For comparison, this
primary estimate represents a 37% reduction in clients served compared
to the average of clients served from 2016 to 2018. In the Uncertainty
and Sensitivity Analysis Section, we adopt the 1.5 million client
figure as a lower-bound estimate, and 3.1 million clients as an upper-
bound estimate of the annual program impact under the baseline.
Table D2 summarizes our baseline forecast for the same categories
of historical data presented in Table D1. We adopt the current count
for grantees, subrecipients, and services sites. We assume these
figures will be constant over time horizon of this analysis.
Table D2--Baseline Forecast of Title X Services
------------------------------------------------------------------------
Baseline forecast Annual
------------------------------------------------------------------------
Grantees................................................ 73
Subrecipients........................................... 803
Service Sites........................................... 2,682
Clients Served.......................................... 2,512,066
------------------------------------------------------------------------
In addition to the reduction in grantees, subrecipients, service
sites, and total client served, we note that six states currently have
no Title X services, including HI, ME, OR, UT, VT, and WA. There are
six additional states that have limited Title X services, including AK,
CT, MA, MN, NH, and NY.\43\
---------------------------------------------------------------------------
\43\ As noted earlier, seven states (CO, DE, KY, ND, NM, NV, TX)
experienced a meaningful increase in the number of Title X clinics
after the 2019 regulatory change.
---------------------------------------------------------------------------
In line with the reduction in clients served under the 2019 Final
Rule, data also reveal a significant drop in services provided For
example, when comparing 2019 figures to 2018, 225,688 fewer clients
received oral contraceptives; 49,803 fewer clients received hormonal
implants; and 86,008 fewer clients received intrauterine devices
(IUDs). For oral contraceptives and IUDs, this was a 27% reduction; and
for hormonal implants, a 21% reduction. These percentages are similar
in magnitude to the 21% reduction in clients served in 2019 compared to
2018. Additionally, 90,386 and 188,920 fewer Pap tests and clinical
breast exams, respectively, were performed in 2019 compared to 2018.
Confidential HIV tests decreased by 276,109. Testing for sexually
transmitted infections (STIs) decreased by 256,523 for chlamydia, by
625,802 for gonorrhea, and by 77,524 for syphilis.
For our forecast of services provided under our baseline scenario,
we adopt the most recent percentage of clients receiving each service
in the 2019 Title X Family Planning Annual Report. For example, in
2019, about 23% of female clients received a clinical breast exam. We
assume the same share of clients will be served by Title X for
screening and sexually transmitted infection testing. Table D3 reports
our best estimate of the annual services provided under the baseline
scenario. We describe these services in greater detail later in this
Section.
Table D3--Baseline Title X Cancer Screening and Sexually Transmitted
Infection Testing
------------------------------------------------------------------------
Year Annual
------------------------------------------------------------------------
Clinical Breast Exams................................... 509,550
Pap Tests............................................... 443,087
Chlamydia Test.......................................... 1,266,508
Gonorrhea Test.......................................... 1,420,198
Syphilis Test........................................... 536,619
[[Page 19823]]
Confidential HIV Test................................... 777,536
------------------------------------------------------------------------
Source: Calculations based on Title X Family Planning Annual Report,
2019: Exhibits 26 and 29.
We predict that the main effect of the proposed rule would be to
return to Title X program impact levels observed prior to the 2019
Final Rule. Our estimates of the long-run equilibrium of grantees,
subrecipients, service sites, and total client served are informed by
the data from fiscal years 2016-2018, the last three years of data that
are unaffected by the drops experienced following the 2019 Final Rule.
Specifically, we adopt the average across these three years as our
long-run estimates. These averages are 93 grantees, 1,112
subrecipients, 3,903 service sites, and about 4.0 million clients
served.
To complete our forecast of the policy scenario, we assume that it
will take two years for program participation and clients served to
achieve the long-run equilibrium estimates. This two-year phase-in is
consistent with a scenario in which most service sites that withdrew
from the Title X program have remained open, with some operating at a
lower capacity, than they did prior to the 2019 Final Rule. It is also
consistent with an expectation that many of the grantees and service
sites that withdrew from the program would be able to rejoin if this
proposed rule were finalized. In year one, following the effective date
of the proposed rule, the number of clients served would increase to
about 3.2 million. In year two, this number would increase again to
about 4.0 million and remain there for the duration of our analysis.
These figures are presented in Table D4. We acknowledge uncertainty in
this estimate, and include a discussion in the Uncertainty and
Sensitivity Section, below.
Table D4--Policy Scenario Forecast of Title X Service Grantees
----------------------------------------------------------------------------------------------------------------
Year 2022 2023 2024 2025 2026
----------------------------------------------------------------------------------------------------------------
Grantees........................ 80 86 93 93 93
Subrecipients................... 906 1,009 1,112 1,112 1,112
Service Sites................... 3,089 3,496 3,903 3,903 3,903
Clients Served.................. 3,247,958 3,983,849 3,983,849 3,983,849 3,983,849
----------------------------------------------------------------------------------------------------------------
To characterize the effect of the proposed rule, we compare the
policy scenario forecast to the baseline forecast described in the
previous section. Table D5 reports the difference between these two
scenarios, which represents the net effect of the proposed rule. For
example, in year 1 after this rule is effective, the number of clients
served would be about 736,000 higher than under the baseline scenario.
Approximately 88% of clients served in 2016-2018 are female, and we use
this percentage to estimate the increase in clients served by sex under
the policy scenario.
Table D5--Effect of the Proposed Rule on Title X Services
----------------------------------------------------------------------------------------------------------------
Year 2022 2023 2024 2025 2026
----------------------------------------------------------------------------------------------------------------
Increase in Grantees............ 7 13 20 20 20
Increase in Subrecipients....... 103 206 309 309 309
Increase in Service Sites....... 407 814 1,221 1,221 1,221
Increase in Clients Served...... 735,892 1,471,783 1,471,783 1,471,783 1,471,783
Female...................... 648,996 1,297,992 1,297,992 1,297,992 1,297,992
Male........................ 86,896 173,791 173,791 173,791 173,791
----------------------------------------------------------------------------------------------------------------
Clients served under the Title X program experience outcomes that
include reducing unintended pregnancy through greater access to
contraception. The averted unintended pregnancies translate to a
reduction in unplanned births, a reduction in abortions, and reduction
in miscarriages. Also, Title X clients receive cancer screenings and
testing for sexually transmitted infections. These screenings and
testing can identify treatable conditions, improving the quality of
life and extending the lives of beneficiaries. In the case of sexually
transmitted infections, additional testing can reduce the likelihood of
further infections and future infertility. This proposed rule would
expand service to socioeconomically disadvantaged populations, most of
whom are female, low income, and young. We discuss this in greater
detail in the Section on Distributional Effects.
To further explore the likely effect of the Title X program on
unintended pregnancy, we rely on existing methodology for estimating
number of unintended pregnancies prevented each year among U.S. women
who depend on publicly funded family planning services.\44\ Among this
subgroup of women who use any method of contraception, 46 in 1,000
women are expected to experience an unintended pregnancy. This figure
can be compared to 296 unintended pregnancies per 1,000 women who are
unable to access public family planning services. We apply this
estimate of a reduction of 250 unintended pregnancies per 1,000
contraception clients to the number of additional female clients served
under the Title X program who adopt any method of contraception.
---------------------------------------------------------------------------
\44\ Jennifer J. Frost and Lawrence B. Finer (2017). Memo
entitled ``Unintended pregnancies prevented by publicly funded
family planning services: Summary of results and estimation
formula.'' https://www.guttmacher.org/sites/default/files/pdfs/pubs/Guttmacher-Memo-on-Estimation-of-Unintended-Pregnancies-Prevented-June-2017.pdf. Accessed on March 14, 2021.
---------------------------------------------------------------------------
For year 1, we multiply 735,892 clients by 88% to yield 648,996
clients who are women. Among female clients, approximately 14% indicate
they are not using a method of contraception, according to figures in
the 2019 Title X Family Planning Annual Report. We reduce the potential
number of clients that would potentially reduce the likelihood of an
unintended pregnancy by 14% to yield 558,205 clients expected to
benefit from a contraceptive method. Approximately 47% of unintended
pregnancies result in
[[Page 19824]]
unplanned births, 34% in abortion, and 19% in a miscarriage.\45\
---------------------------------------------------------------------------
\45\ Jennifer J. Frost, Lori F. Frohwirth, Nakeisha Blades, Mia
R. Zolna, Ayana Douglas-Hall, and Jonathan Bearak (2017). ``Publicly
Funded Contraceptive Services at U.S. Clinics, 2015. https://www.guttmacher.org/sites/default/files/report_pdf/publicly_funded_contraceptive_services_2015_3.pdf. Accessed on March
14, 2021.
Table D6--Effect of the Proposed Rule on Title X-Associated Contraception
----------------------------------------------------------------------------------------------------------------
Year 2022 2023 2024 2025 2026
----------------------------------------------------------------------------------------------------------------
Clients Served.................. 735,892 1,471,783 1,471,783 1,471,783 1,471,783
Women Served.................... 648,996 1,297,992 1,297,992 1,297,992 1,297,992
Women Served Using Contraception 558,205 1,116,411 1,116,411 1,116,411 1,116,411
----------------------------------------------------------------------------------------------------------------
Unintended and unplanned pregnancies increase the risk for poor
maternal and infant outcomes. Women who give birth following an
unintended or unplanned pregnancy are less likely to have benefitted
from preconception care, to have optimal spacing between births, and to
have been aware of their pregnancy early on, which in turn makes it
less likely that they would have received prenatal care early in
pregnancy.46 47
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\46\ Jessica D. Gipson, Michael A. Koenig, and Michelle J.
Hindin. ``The Effects of Unintended Pregnancy on Infant, Child, and
Parental Health: A Review of the Literature.'' Studies in family
planning 39.1 (2008): 18-38. Web.
\47\ Power to Decide. Maternal and Infant Health and the
Benefits of Birth Control in America. Accessed on March 8, 2020 from
https://powertodecide.org/sites/default/files/resources/supporting-materials/getting-the-facts-straight-chapter-3-maternal-infant-health.pdf.
---------------------------------------------------------------------------
Title X funding recipients also perform preventive health services
such as cervical and breast cancer screening, and testing for sexually
transmitted infections, including chlamydia, gonorrhea, syphilis, and
HIV. Table D6 presents the effect of the proposed rule on Title X-
associated cervical and breast cancer screenings. These figures are
calculated by multiplying the number of additional women served by the
program in each year by about 23% for clinical breast exams, of which
5% result in a referral for further evaluation; and 20% for Pap
testing, of which 13% with a result of atypical squamous cells (ASC)
that require further evaluation and possibly treatment, and 1% of which
have a high-grade squamous intraepithelial lesion (HSIL) \48\ or
higher, indicating the presence of a more severe condition.
---------------------------------------------------------------------------
\48\ HSIL is the abnormal growth of certain cells on the surface
of the cervix.
---------------------------------------------------------------------------
Clinical breast exams can identify women requiring further
evaluation of an abnormal finding. Pap test (or pap smear test) results
can indicate viral infections that, when untreated, can turn into
cervical cancer. The Pap test results can also detect cervical cancer
cells. At a population level, these screenings save lives by helping
women identify cancer earlier, and preventing other conditions from
developing into cancer.
Table D7--Effect of the Proposed Rule on Title X-Associated Cervical and Breast Cancer Screening Activities
----------------------------------------------------------------------------------------------------------------
Year 2022 2023 2024 2025 2026
----------------------------------------------------------------------------------------------------------------
Clinical Breast Exams........... 149,269 298,538 298,538 298,538 298,538
Referred.................... 7,463 14,927 14,927 14,927 14,927
Pap Tests....................... 129,799 259,598 259,598 259,598 259,598
Tests with ASC or higher.... 17,304 34,609 34,609 34,609 34,609
Tests with HSIL or higher... 195 391 391 391 391
----------------------------------------------------------------------------------------------------------------
Table D7 presents the effect of the proposed rule on Title X-
associated testing for sexually transmitted infections among female
clients. These are calculated by adopting estimates that 49% of women
are tested for chlamydia; 55% for gonorrhea; 19% for syphilis; and 28%
for HIV. Table D6 presents the same information for men. The share of
male clients tested for these infections are the following: 61% for
chlamydia, 68% for gonorrhea, 39% for syphilis, and 53% for HIV.
Table D8--Additional Women Tested for Sexually Transmitted Infections Under Title X
----------------------------------------------------------------------------------------------------------------
Year 2022 2023 2024 2025 2026
----------------------------------------------------------------------------------------------------------------
Chlamydia....................... 318,008 636,016 636,016 636,016 636,016
Gonorrhea....................... 356,948 713,895 713,895 713,895 713,895
Syphilis........................ 123,309 246,618 246,618 246,618 246,618
Confidential HIV................ 181,719 363,438 363,438 363,438 363,438
----------------------------------------------------------------------------------------------------------------
Table D9--Additional Men Tested for Sexually Transmitted Infections Under Title X
----------------------------------------------------------------------------------------------------------------
Year 2022 2023 2024 2025 2026
----------------------------------------------------------------------------------------------------------------
Chlamydia....................... 53,006 106,013 106,013 106,013 106,013
Gonorrhea....................... 59,089 118,178 118,178 118,178 118,178
Syphilis........................ 33,889 67,779 67,779 67,779 67,779
[[Page 19825]]
Confidential HIV................ 46,055 92,109 92,109 92,109 92,109
----------------------------------------------------------------------------------------------------------------
Table D8 reports the total clients tested for sexually transmitted
infections. These tests can identify treatable conditions that can
cause discomfort, permanent damage to reproductive systems including
infertility, and in certain cases, death. The 2019 Title X Family
Planning Annual Report indicates confidential HIV testing identifies a
positive case for approximately 0.38% of all HIV tests performed. If
the proposed rule is finalized, Title X would be associated with
identifying an additional 873 positive cases of HIV. In subsequent
years, this number would increase to 1,745. Testing for these sexually
transmitted infections can also reduce the likelihood that an
individual will spread an infection. In addition to testing, Title X-
funded service sites also provide HIV/AIDS prevention education. Pre-
exposure prophylaxis (PrEP) has emerged as an effective HIV prevention
strategy for individuals who are most at risk, and the inclusion of
PrEP in the HIV prevention services provided at Title X sites is
becoming an increasingly important method for protecting individuals of
all ages from acquiring HIV.
Table D10--Additional Clients Tested for Sexually Transmitted Infections Under Title X
----------------------------------------------------------------------------------------------------------------
Year 2022 2023 2024 2025 2026
----------------------------------------------------------------------------------------------------------------
Chlamydia....................... 371,014 742,029 742,029 742,029 742,029
Gonorrhea....................... 416,037 832,074 832,074 832,074 832,074
Syphilis........................ 157,199 314,397 314,397 314,397 314,397
Confidential HIV................ 227,774 455,547 455,547 455,547 455,547
Positive Test Results....... 873 1,745 1,745 1,745 1,745
----------------------------------------------------------------------------------------------------------------
Services of the type provided under Title X likely result in
reduced costs to taxpayers as a result of a reduction in unintended
pregnancies, pre-term and low-birthweight births, sexually transmitted
infections, infertility, and cervical cancer. This report \49\
estimates that each dollar spent on these services results in a net
Government saving of $7.09. We do not replicate the calculations, but
note that they are derived from cost savings associated with averting
unintended pregnancy and complications such as pre-term and low birth-
weight births. These cost savings are also derived from detecting and
treating sexually transmitted infections that would have resulted in
more serious outcomes, including infertility, cancer, and death.
---------------------------------------------------------------------------
\49\ Jennifer J. Frost, Adam Sonfield, Mia R. Zolna, and
Lawrence B. Finer (2014). ``Return on Investment: A fuller
assessment of the benefits and costs of the US publicly funded
family planning program'' Milbank Quarterly 2014 Dec;92(4):696-749.
---------------------------------------------------------------------------
In addition to the effects described above, this proposed rule
would also enhance the equity and dignity associated with access to
family planning services provided by Title X. A recent research brief
summarized interviews with 30 women sharing their experiences with
contraceptive access, providing suggestive evidence that birth control
has an important positive impact on women's lives. Interviewees noted
that birth control allowed women to ``to pursue academic and
professional goals, achieve financial stability, and maintain their
mental and physical health.'' \50\ These recent interviews are
consistent with the historical experience of the importance of birth
control. For example, one econometric study identifies a causal
relationship between the introduction and diffusion of the birth
control pill and the increase in women enrolling in professional degree
programs and increasing the age at first marriage.\51\ Title X services
help connect women with the free contraception provided by the
Affordable Care Act, which allows them to experience these and other
positive outcomes associated with access to contraception.
---------------------------------------------------------------------------
\50\ Rebecca Peters, Sarah Benetar, Brigette Courtot, and Sophia
Yin (2019). ``Birth Control is Transformative.'' Urban Institute.
https://www.urban.org/sites/default/files/publication/99912/birth_control_is_transformative_1.pdf. Accessed April 6, 2021.
\51\ Goldin, Claudia and Lawrence F. Katz (2002). ``The power of
the pill: Oral contraceptives and women's career and marriage
decisions.'' Journal of Political Economy 110(4): 730-770.
---------------------------------------------------------------------------
Researchers have identified other economic, social, and health
impacts of increased access to family planning, contraception, and
treatment. For example, Bailey et al. (2019) finds ``that children born
after the introduction of Federal family planning programs were 7
percent less likely to live in poverty and 12 percent less likely to
live in households receiving public assistance.'' They perform an
additional bounding analysis, which suggests that about two thirds of
the estimated gains are due to increases in the incomes of parents.\52\
A recent summary discusses other impacts of access to family planning
services in the United States and in other countries, which extends
beyond women and girls, to their children and wider communities.\53\
---------------------------------------------------------------------------
\52\ Bailey, Martha J., Olga Malkova, Zo[euml] M. McLaren
(2019). ``Does Access to Family Planning Increase Children's
Opportunities? Evidence from the War on Poverty and the Early Years
of Title X.'' Journal of Human Resources 54:4 pp. 825-856.
doi:10.3368/jhr.54.4.1216-8401R1.
\53\ Emily Sohn (2020). ``Strengthening society with
contraception.'' Nature 588, S162-S164.
---------------------------------------------------------------------------
The calculations above represent observable metrics of the effect
of the Title X program, which is important for evaluating the direct
effect of the program. For this reason, the scope of our analysis
initially focuses on clients served and services provided by Title X
facilities. To properly account for the net effect of the proposed rule
when comparing the baseline scenario to the policy scenario, we would
need to assess the extent to which clients and services continue to be
provided through other channels than Title X funded sites without the
proposed rule. As a general matter, the impacts of this proposed rule
may include:
Transfers between grantees and would-be grantees within
the Title X program;
other transfers (for example, if Title X newly funds
medical services that would, in the absence of the proposed rule, be
provided by charitable
[[Page 19826]]
organizations or other private payers); and
societal benefits and costs to the extent that the volume
or characteristics (such as location, which determines travel costs) of
medical services would differ with and without the proposed rule.
As noted earlier in this preamble, all Planned Parenthood
affiliates--which, in 2015, served 41 percent of all contraceptive
clients at Title X-funded service sites--withdrew from Title X due to
the 2019 Final Rule. However, a comparison of Planned Parenthood's two
most recent annual financial reports indicates no subsequent decrease
in the number of patients served and an increase, from 9.8 million to
10.4 million, in the number of services provided per annum (pre-
pandemic).\54\ Although such year-to-year comparisons are simplistic
and a focus on just one organization (even a prominent one, with
extensive activities) has obvious limitations, this evidence may
suggest that the Title X program impacts quantified elsewhere in this
regulatory impact analysis may largely be associated with transfers.
Although there are notable challenges with quantifying the benefit,
cost and transfer impacts of the proposed rule, we request comment that
might facilitate refinement of the analysis prior to regulatory
finalization.
---------------------------------------------------------------------------
\54\ Please see https://www.plannedparenthood.org/uploads/filer_public/2e/da/2eda3f50-82aa-4ddb-acce-c2854c4ea80b/2018-2019_annual_report.pdf and https://www.plannedparenthood.org/uploads/filer_public/67/30/67305ea1-8da2-4cee-9191-19228c1d6f70/210219-annual-report-2019-2020-web-final.pdf. The latter report
indicates that Planned Parenthood conducted a major fundraising
campaign with the 2019 Title X regulatory changes as its key
motivating message. If funds are more efficiently gathered and
distributed via a program such as Title X than through such private
campaigns, the efficiency would represent a cost savings
attributable to the proposed rule.
---------------------------------------------------------------------------
e. Further Discussion of Distributional Effects
The Title X program is designed to provide services with priority
given to persons from low-income families. According to the most recent
data, 64% of clients have income under 101% of the Federal poverty
level; 14% between 101% and 150%; 7% between 151% to 200%; 3% between
201% and 250%; 7% over 250%; and 5% have an unknown or unreported
income level. Among program clients, 33% are Hispanic or Latino of all
races; 3% are Asian and Not Hispanic or Latino; 22% are Black or
African American and Not Hispanic or Latino; 32% are White and Not
Hispanic or Latino; and 5% are Other or Unknown and Not Hispanic or
Latino; and 4% are Unknown or not Reported. Furthermore, the Title X
statutory directive requires Title X projects to provide services for
adolescents without required parental consent. This makes Title X a
critical source of sexual and reproductive healthcare for young people.
In 2019, 2% program clients were younger than 15, and 8% were younger
than 18. Additional information about the number and distribution of
all family planning clients by age and year are available in Exhibit A-
3a of the 2019 Title X Annual Report. The benefits of revoking the 2019
Final Rule would likely accrue roughly in proportion with these income
and race and ethnicity figures. The costs of revoking the 2019 Final
Rule would likely accrue proportional to the income and other
demographics of the general public.
This proposed rule would also likely have important geographic
effects. As described in greater detail in the Baseline Section, 6
States currently have no Title X services, and 6 additional states have
limited Title X services. This proposed rule would likely result in
restoration of services to individuals in these States.
f. Uncertainty and Sensitivity Analysis
All of the major drivers of the quantified effects of this analysis
are dependent on our forecast of the baseline number of clients served.
We acknowledge the uncertainty in this baseline and have performed a
sensitivity analysis to quantify its importance. For our primary
baseline, we chose 2.5 million annual clients of Title X services,
which corresponds to the number of clients in fiscal year 2019 among
remaining grantees. As a sensitivity analysis, we investigate the
effect of the proposed rule compared to a baseline with 1.5 million
clients, corresponding to preliminary estimates for fiscal year 2020.
For comparison, we also looked at the effects using an upper bound of
3.1 million clients served, which is the reported figure for 2019, but
which includes 19 grantees, 231 subrecipients, and 945 service sites
that withdraw from the Title X program following the 2019 Final Rule.
Table F1 presents the number of clients served under different
assumptions of the baseline. We also recalculate the number of clients
served for the proposed rule scenario for each of the baseline
assumptions. Since the number of clients served in the first year is
the midpoint between the baseline and long-run equilibrium figure, the
number of clients served in fiscal year 2022 under the proposed rule
would be lower for the lower-bound scenario than the primary baseline.
Similarly, the number of clients served under the proposed rule would
be higher in the upper-bound scenario.
Table F1--Title X Clients Served Under Different Baseline Assumptions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed rule, Proposed rule,
Year Baseline Baseline, LB Baseline, UB Proposed rule LB UB
--------------------------------------------------------------------------------------------------------------------------------------------------------
2022.................................................... 2,512,066 1,536,744 3,095,666 3,247,958 2,760,297 3,539,758
2023.................................................... 2,512,066 1,536,744 3,095,666 3,983,849 3,983,849 3,983,849
2024.................................................... 2,512,066 1,536,744 3,095,666 3,983,849 3,983,849 3,983,849
2025.................................................... 2,512,066 1,536,744 3,095,666 3,983,849 3,983,849 3,983,849
2026.................................................... 2,512,066 1,536,744 3,095,666 3,983,849 3,983,849 3,983,849
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table F2 calculates the effect of the proposed rule under different
baseline assumptions. These estimates are reported by year, as well as
in present value and annualized for the 5-year time horizon of our
analysis, applying a 3% and a 7% discount rate. Under the lower-bound
baseline scenario, the proposed rule would have about a 66% greater
impact on the number of clients served in annualized terms under the
primary baseline scenario. Under the upper-bound baseline scenario, the
proposed rule would have about a 64% lesser impact.
[[Page 19827]]
Table F2--Effect of the Proposed Rule Under Different Baseline Assumptions
----------------------------------------------------------------------------------------------------------------
Proposed rule, Proposed rule,
Year Proposed rule LB UB
----------------------------------------------------------------------------------------------------------------
2022............................................................ 735,892 1,223,553 444,092
2023............................................................ 1,471,783 2,447,105 888,183
2024............................................................ 1,471,783 2,447,105 888,183
2025............................................................ 1,471,783 2,447,105 888,183
2026............................................................ 1,471,783 2,447,105 888,183
PDV, 3%......................................................... 6,025,877 10,019,109 3,636,461
PDV, 7%......................................................... 5,346,852 8,890,107 3,226,687
Annualized, 3%.................................................. 1,315,778 2,187,718 794,038
Annualized, 7%.................................................. 1,304,047 2,168,214 786,959
----------------------------------------------------------------------------------------------------------------
As discussed earlier, we acknowledge uncertainty in how quickly the
Title X program will be able to restore service to levels experienced
prior to the drops associated with the 2019 Final Rule. Our primary
analysis adopts a two-year phase for grantees, subrecipients, service
sites, and clients served to reach our long-run equilibrium estimates.
If a large number of service sites have shut down permanently, the
assumption of a two-year phase in would likely result in an
overestimate of the proposed rule's effect over the time horizon of the
analysis. Similarly, if a small number of service sites have shut down,
the analysis would tend to underestimate the effect of the proposed
rule. Therefore, as a second sensitivity analysis, we present estimates
that adopt alternative assumptions about the length of time it will
take to reach the long-run equilibrium estimates. Table F3 presents our
primary estimates, based on a two-year phase in, estimates without a
phase in, and estimates with a 3-year phase in assumption.
Table F3--Title X Clients With Different Phase-In Assumptions
----------------------------------------------------------------------------------------------------------------
Proposed rule, Proposed rule,
Year Baseline 2-year phase Proposed rule, 3-year phase
in no phase in in
----------------------------------------------------------------------------------------------------------------
2022............................................ 2,512,066 3,247,958 3,983,849 3,002,660
2023............................................ 2,512,066 3,983,849 3,983,849 3,493,255
2024............................................ 2,512,066 3,983,849 3,983,849 3,983,849
2025............................................ 2,512,066 3,983,849 3,983,849 3,983,849
2026............................................ 2,512,066 3,983,849 3,983,849 3,983,849
----------------------------------------------------------------------------------------------------------------
Table H4 calculates the effect of the proposed rule with different
phase-in assumptions. These estimates are reported by year, as well as
in present value and annualized for the 5-year time horizon of our
analysis, applying a 3% and a 7% discount rate. Compared to our primary
estimates, the assumption of no phase in yields annualized effects of
the proposed rule that are about 12% higher. Assuming a 3-year phase in
yields annualized effects that are about 12% lower than the primary
estimates.
Table F4--Effect of the Proposed Rule With Different Phase-In Assumptions
----------------------------------------------------------------------------------------------------------------
Proposed rule, Proposed rule,
Year 2-year phase Proposed rule, 3-year phase
in no phase in in
----------------------------------------------------------------------------------------------------------------
2022............................................................ 735,892 1,471,783 490,594
2023............................................................ 1,471,783 1,471,783 981,189
2024............................................................ 1,471,783 1,471,783 1,471,783
2025............................................................ 1,471,783 1,471,783 1,471,783
2026............................................................ 1,471,783 1,471,783 1,471,783
PDV, 3%......................................................... 6,025,877 6,740,335 5,325,293
PDV, 7%......................................................... 5,346,852 6,034,601 4,689,098
Annualized, 3%.................................................. 1,315,778 1,471,783 1,162,802
Annualized, 7%.................................................. 1,304,047 1,471,783 1,143,627
----------------------------------------------------------------------------------------------------------------
g. Analysis of Regulatory Alternatives to the Proposed Rule
We analyzed two alternatives to the approach under the proposed
rule. We considered one option to maintain many elements of the 2019
Final Rule and to impose additional restrictions on grantees. This
approach would exacerbate the trends of reduced Title X grantees,
subrecipients, service sites, and clients served that we have observed
under the 2019 Final Rule. Second, we considered revising the 2019
Final Rule by readopting many elements of the 2000 regulations, but
adopting additional flexibilities for grantees and reducing
programmatic oversight. However, our experience suggests the compliance
regime as it existed prior to the 2019 Final Rule was effective.
VI. Environmental Impact
We have determined under 21 CFR 25.30(k) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an
[[Page 19828]]
environmental assessment nor an environmental impact statement is
required.
VII. 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 1. 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.
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. 59.5 (What requirements
must be met by a family planning project?) and Sec. 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?).
Proposed Sec. 59.4 would require Title X grant applicants to
describe how the proposed project would satisfy the regulatory
requirements for the Title X program in their applications. All other
reporting burden associated with grant applications is already approved
via existing Grants.gov common forms.
Proposed Sec. 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
description of the extent of collaboration and a clear explanation of
how the grantee would ensure adequate oversight and accountability.
Proposed Sec. 59.5 would also 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. 59.5, and make continuation of funding for Title
X services contingent upon demonstrating to the Secretary that the
criteria have been met.
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 1 hour
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 1060, based on 2019 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
$69.86 per hour for the lawyer and $55.37 per hour for the medical and
health service manager. The labor cost is $132,750 in the first year
(($69.86 x 1 + $55.37 x 1) x 1060 grantees and subrecipients). We
estimate that the cost, in subsequent years, would be $95,700 which
would represent an annual allotment of 30 minutes for the lawyer and
one hour for the medical and health service manager (($69.86 x 0.5 +
$55.37 x 1) x 1060 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 2 hours and a medical and
health service manager spending an average of 2 hours. The labor cost
for self-assessing compliance, such as reviewing policies and
procedures, is a total of $265,500 each year (($69.86 x 2 + $55.37 x 2)
x 1060 grantees and subrecipients).
The burden for the documentation of compliance is the cost of
grantee and/or subrecipient staff time to (a) complete reports
regarding information related to subrecipients, referral agencies and
individuals involved in the grantee's Title X project.
The labor cost would include a medical and health services manager
spending an average of two 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 $117,400 each year
($55.37 x 2 hours x 1060 grantees and subrecipients).
Table 1--Proposed Annual Recordkeeping and Reporting Requirements or Burden of Response in Year One/Subsequent Years Following Publication of the Final
Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Burden per Total annual
Regulation burden OMB control Respondents Hourly rate response burden Labor cost of
No. responses ($) (hours) (hours) reporting ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Assurance of Compliance................................. 0938-New 1060/1060 62.62/62.62 6/5.44 6360/5766 398,250/
361,200
Documentation of Compliance............................. 0938-New 1060/1060 55.37/55.37 2/2 2120/2120 117,400/
117,400
-----------------------------------------------------------------------------------------------
[[Page 19829]]
Total cost.......................................... .............. .............. .............. .............. .............. 516,650/
478,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: 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
Birth control, Contraception, Family planning, Grant programs,
Health facilities, Title X.
Xavier Becerra,
Secretary, Department of Health and Human Services.
PART 59--GRANTS FOR FAMILY PLANNING
For the reasons set out in the preamble, subpart A of part 59 of
title 42, Code of Federal Regulations, is hereby proposed to be revised
to read as follows:
Subpart A--Project Grants for Family Planning Services
Sec.
59.1 To what programs do the regulations in this subpart apply?
59.2 Definitions.
59.3 Who is eligible to apply for a family planning services grant?
59.4 How does one apply for a family planning services grant?
59.5 What requirements must be met by a family planning project?
59.6 What procedures apply to assure the suitability of
informational and educational material?
59.7 What criteria will the Department of Health and Human Services
use to decide which family planning services projects to fund and in
what amount?
59.8 How is a grant awarded?
59.9 For what purposes may grant funds be used?
59.10 Confidentiality.
59.11 Additional conditions.
59.12 What other HHS regulations apply to grants under this subpart?
Subpart A--Project Grants for Family Planning Services
Authority: 42 U.S.C. 300a-4.
Sec. 59.1 To what programs do the regulations in this subpart apply?
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.
3200) 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.
Sec. 59.2 Definitions.
As used in this subpart:
Act means the Public Health Service Act, as amended.
Adolescent-friendly health services are services that are
accessible, acceptable, equitable, appropriate and effective for
adolescents.
Client-centered care is respectful of, and responsive to,
individual client preferences, needs, and values; client values guide
all clinical decisions.
Culturally and linguistically appropriate services are respectful
of and responsive to the health beliefs, practices and needs of diverse
patients.
Family means a social unit composed of one person, or two or more
persons living together, as a household.
Family planning services include a broad range of medically
approved contraceptive services, which includes Food and Drug
Administration (FDA)-approved contraceptive services and natural family
planning methods, for clients who want to prevent pregnancy and space
births, pregnancy testing and counseling, assistance to achieve
pregnancy, basic infertility services, sexually transmitted infection
(STI) services, and other preconception health services.
Health equity is when every person has the opportunity to attain
their full health potential and no one is disadvantaged from achieving
this potential because of social position or other socially determined
circumstances.
Inclusivity ensures that all people are fully included and can
actively participate in and benefit from family planning, including,
but not limited to, individuals who belong to underserved communities,
such as Black, Latino, and Indigenous and Native American persons,
Asian Americans and Pacific Islanders and other persons of color;
members of religious minorities; lesbian, gay, bisexual, transgender,
and queer (LGBTQ+) persons; persons with disabilities; persons who live
in rural areas; and persons otherwise adversely affected by persistent
poverty or inequality.
Low-income family means a family whose total annual 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 family 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,
unemancipated minors who wish to receive services on a confidential
basis must be considered on the basis of their own resources.
Nonprofit, as applied to any private agency, institution, or
organization, means that no part of the entity's net earnings benefit,
or may lawfully benefit, any private shareholder or individual.
Quality healthcare is safe, effective, client-centered, timely,
efficient, and equitable.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
Service site is a clinic or other location where Title X services
(under the Act) are provided to clients. Title X recipients and/or
their subrecipients may have service sites.
State includes, in addition to the several States, the District of
Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana
Islands, the U.S. Virgin Islands, American Samoa, the U.S. Outlaying
Islands (Midway, Wage, et al.), the Marshall Islands, the Federated
State of Micronesia and the Republic of Palau.
[[Page 19830]]
Trauma-informed means a program, organization, or system that is
trauma-informed realizes the widespread impact of trauma and
understands potential paths for recovery; recognizes the signs and
symptoms of trauma in clients, families, staff, and others involved
with the system; and responds by fully integrating knowledge about
trauma into policies, procedures, and practices, and seeks to actively
resist re-traumatization.
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.
Sec. 59.4 How does one apply for a family planning services grant?
(a) Application for a grant under this subpart shall be made on an
authorized form.
(b) An individual authorized to act for the applicant and to assume
on behalf of the applicant the obligations imposed by the terms and
conditions of the grant, including the regulations of this subpart,
must sign the application.
(c) The application shall contain--
(1) A description, satisfactory to the Secretary, of the project
and how it will meet the requirements of this subpart;
(2) A budget and justification of the amount of grant funds
requested;
(3) A description of the standards and qualifications which will be
required for all personnel and for all facilities to be used by the
project; and
(4) Such other pertinent information as the Secretary may require.
Sec. 59.5 What requirements must be met by a family planning project?
(a) Each project supported under this part must:
(1) Provide a broad range of acceptable and effective medically
approved family planning methods (including natural family planning
methods) and services (including pregnancy testing and counseling,
assistance to achieve pregnancy, basic infertility services, STI
services, preconception health services, and adolescent-friendly health
services). If an organization offers only a single method of family
planning, it may participate as part of a project as long as the entire
project offers a broad range of acceptable and effective medically
approved family planning methods and services. Title X service sites
that are unable to provide clients with access to a broad range of
acceptable and effective medically approved family planning methods and
services, must be able to provide a referral to the client's method of
choice and the referral must not unduly limit the client's access to
their method of choice.
(2) Provide services without subjecting individuals to any coercion
to accept services or to employ or not to employ any particular methods
of family planning. Acceptance of services must be solely on a
voluntary basis and may not be made a prerequisite to eligibility for,
or receipt of, any other services, assistance from or participation in
any other program of the applicant.\1\
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\1\ 42 U.S.C. 300a-8 (Section 205 of Pub. L. 94-63) states:
``Any (1) officer or employee of the United States, (2) officer or
employee of any State, political subdivision of a State, or any
other entity, which administers or supervises the administration of
any program receiving Federal financial assistance, or (3) person
who receives, under any program receiving Federal assistance,
compensation for services, who coerces or endeavors to coerce any
person to undergo an abortion or sterilization procedure by
threatening such person with the loss of, or disqualification for
the receipt of, any benefit or service under a program receiving
Federal financial assistance shall be fined not more than $1,000 or
imprisoned for not more than one year, or both.''
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(3) Provide services in a manner that is client-centered,
culturally and linguistically appropriate, inclusive, and trauma-
informed; protects the dignity of the individual; and ensures equitable
and quality service delivery consistent with nationally recognized
standards of care.
(4) Provide services without regard of religion, race, color,
national origin, disability, age, sex, number of pregnancies, or
marital status.
(5) Not provide abortion as a method of family planning. A project
must:
(i) Offer pregnant clients the opportunity to be provided
information and counseling regarding each of the following options:
(A) Prenatal care and delivery;
(B) Infant care, foster care, or adoption; and
(C) Pregnancy termination.
(ii) If requested to provide such information and counseling,
provide neutral, factual information and nondirective counseling on
each of the options, and referral upon request, except with respect to
any option(s) about which the pregnant client indicates they do not
wish to receive such information and counseling.
(6) Provide that priority in the provision of services will be
given to clients from low-income families.
(7) Provide that no charge will be made for services provided to
any clients from a low-income family except to the extent that payment
will be made by a third party (including a Government agency) which is
authorized to or is under legal obligation to pay this charge.
(8) Provide that charges will be made for services to clients other
than those from low-income families in accordance with a schedule of
discounts based on ability to pay, except that charges to persons from
families whose annual income exceeds 250 percent of the levels set
forth in the most recent Poverty Guidelines issued pursuant to 42
U.S.C. 9902(2) will be made in accordance with a schedule of fees
designed to recover the reasonable cost of providing services.
(i) Family income should be assessed before determining whether
copayments or additional fees are charged.
(ii) With regard to insured clients, clients whose family income is
at or below 250% Federal poverty line (FPL) should not pay more (in
copayments or additional fees) than what they would otherwise pay when
the schedule of discounts is applied.
(9) Take reasonable measures to verify client income, without
burdening clients from low-income families. Recipients that have lawful
access to other valid means of income verification because of the
client's participation in another program may use those data rather
than re-verify income or rely solely on clients' self-report. If a
client's income cannot be verified after reasonable attempts to do so,
charges are to be based on the client's self-reported income.
(10) If a third party (including a Government agency) is authorized
or legally obligated to pay for services, all reasonable efforts must
be made to obtain the third-party payment without application of any
discounts. Where the cost of services is to be reimbursed under title
XIX, XX, or XXI of the Social Security Act, a written agreement with
the title XIX, XX, or XXI agency is required.
(11)(i) Provide that if an application relates to consolidation of
service areas or health resources or would otherwise affect the
operations of local or regional entities, the applicant must document
that these entities have been given, to the maximum feasible extent, an
opportunity to participate in the development of the application. Local
and regional entities include existing or potential subrecipients which
have previously provided or propose to provide family planning services
to the area proposed to be served by the applicant.
(ii) Provide an opportunity for maximum participation by existing
or potential subrecipients in the ongoing policy decision making of the
project.
(12) Title X projects shall comply with all State and local laws
requiring notification or reporting of child abuse,
[[Page 19831]]
child molestation, sexual abuse, rape, incest, intimate partner
violence or human trafficking (collectively, ``State notification
laws''). Title X projects must provide appropriate documentation or
other assurance satisfactory to the Secretary that it:
(i) Has in place and implements a plan to comply with State
notification laws.
(ii) Provides 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 for providers with respect
to notification and reporting of child abuse, child molestation, sexual
abuse, rape, incest, intimate partner violence and human trafficking;
appropriate interventions, strategies, and referrals to improve the
safety and current situation of the patient; and compliance with State
notification laws.
(13) Ensure transparency in the delivery of services by reporting
the following information in grant applications and all required
reports:
(i) Subrecipients and agencies or individuals providing referral
services and the services to be provided;
(ii) Description of the extent of the collaboration with
subrecipients, referral agencies, and any individuals providing
referral services, in order to demonstrate a seamless continuum of care
for clients; and
(iii) Explanation of how the recipient will ensure adequate
oversight and accountability for quality and effectiveness of outcomes
among subrecipients.
(b) In addition to the requirements of paragraph (a) of this
section, each project must meet each of the following requirements
unless the Secretary determines that the project has established good
cause for its omission. Each project must:
(1) Provide for medical services related to family planning
(including consultation by a healthcare provider, examination,
prescription, and continuing supervision, laboratory examination,
contraceptive supplies) and necessary referral to other medical
facilities when medically indicated, and provide for the effective
usage of contraceptive devices and practices.
(2) Provide for social services related to family planning,
including counseling, referral to and from other social and medical
service agencies, and any ancillary services which may be necessary to
facilitate clinic attendance.
(3) Provide for opportunities for community education,
participation, and engagement to:
(i) Achieve community understanding of the objectives of the
program;
(ii) Inform the community of the availability of services; and
(iii) Promote continued participation in the project by diverse
persons to whom family planning services may be beneficial to ensure
access to equitable, affordable, client-centered, quality family
planning services.
(4) Provide for orientation and in-service training for all project
personnel.
(5) Provide services without the imposition of any durational
residency requirement or requirement that the patient be referred by a
physician.
(6) Provide that family planning medical services will be performed
under the direction of a physician with special training or experience
in family planning.
(7) Provide that all services purchased for project participants
will be authorized by the project director or his designee on the
project staff.
(8) Provide for coordination and use of referrals and linkages with
primary healthcare providers, other providers of healthcare services,
local health and welfare departments, hospitals, voluntary agencies,
and health services projects supported by other Federal programs, who
are in close physical proximity to the Title X site, when feasible, in
order to promote access to services and provide a seamless continuum of
care.
(9) Provide that if family planning services are provided by
contract or other similar arrangements with actual providers of
services, services will be provided in accordance with a plan which
establishes rates and method of payment for medical care. These
payments must be made under agreements with a schedule of rates and
payment procedures maintained by the recipient. The recipient must be
prepared to substantiate that these rates are reasonable and necessary.
(10) Provide, to the maximum feasible extent, an opportunity for
participation in the development, implementation, and evaluation of the
project by persons broadly representative of all significant elements
of the population to be served, and by others in the community
knowledgeable about the community's needs for family planning services.
Sec. 59.6 What procedures apply to assure the suitability of
informational and educational material (print and electronic)?
(a) A grant under this section may be made only upon assurance
satisfactory to the Secretary that the project shall provide for the
review and approval of informational and educational materials (print
and electronic) developed or made available under the project by an
Advisory Committee prior to their distribution, to assure that the
materials are suitable for the population or community to which they
are to be made available and the purposes of Title X of the Act. The
project shall not disseminate any such materials which are not approved
by the Advisory Committee.
(b) The Advisory Committee referred to in paragraph (a) of this
section shall be established as follows:
(1) Size. The Committee shall consist of no fewer than five members
and up to as many members the recipient determines, except that this
provision may be waived by the Secretary for good cause shown.
(2) Composition. The Committee shall include individuals broadly
representative of the population or community for which the materials
are intended (in terms of demographic factors such as race, ethnicity,
color, national origin, disability, sex, sexual orientation, gender
identity, age, marital status, income, geography, and including but not
limited to individuals who belong to underserved communities, such as
Black, Latino, and Indigenous and Native American persons, Asian
Americans and Pacific Islanders and other persons of color; members of
religious minorities; lesbian, gay, bisexual, transgender, and queer
(LGBTQ+) persons; persons with disabilities; persons who live in rural
areas; and persons otherwise adversely affected by persistent poverty
or inequality).
(3) Function. In reviewing materials, the Advisory Committee shall:
(i) Consider the educational, cultural, and diverse backgrounds of
individuals to whom the materials are addressed;
(ii) Consider the standards of the population or community to be
served with respect to such materials;
(ii) Review the content of the material to assure that the
information is factually correct, medically accurate, culturally and
linguistically appropriate, inclusive, and trauma informed;
(iii) Determine whether the material is suitable for the population
or community to which is to be made available; and
(iv) Establish a written record of its determinations.
Sec. 59.7 What criteria will the Department of Health and Human
Services use to decide which family planning services projects to fund
and in what amount?
(a) Within the limits of funds available for these purposes, the
Secretary may award grants for the
[[Page 19832]]
establishment and operation of those projects which will in the
Department's judgment best promote the purposes of section 1001 of the
Act, taking into account:
(1) The number of clients, and, in particular, the number of low-
income clients to be served;
(2) The extent to which family planning services are needed
locally;
(3) The ability of the applicant to advance health equity;
(4) The relative need of the applicant;
(5) The capacity of the applicant to make rapid and effective use
of the Federal assistance;
(6) The adequacy of the applicant's facilities and staff;
(7) The relative availability of non-Federal resources within the
community to be served and the degree to which those resources are
committed to the project; and
(8) The degree to which the project plan adequately provides for
the requirements set forth in these regulations.
(b) The Secretary shall determine the amount of any award on the
basis of his estimate of the sum necessary for the performance of the
project. No grant may be made for less than 90 percent of the project's
costs, as so estimated, unless the grant is to be made for a project
which was supported, under section 1001, for less than 90 percent of
its costs in fiscal year 1975. In that case, the grant shall not be for
less than the percentage of costs covered by the grant in fiscal year
1975.
(c) No grant may be made for an amount equal to 100 percent for the
project's estimated costs.
Sec. 59.8 How is a grant awarded?
(a) The notice of grant award specifies how long Department of
Health and Human Services (HHS) intends to support the project without
requiring the project to recompete for funds. This anticipated period
will usually be for three to five years.
(b) Generally the grant will initially be for one year and
subsequent continuation awards will also be for one year at a time. A
recipient must submit a separate application to have the support
continued for each subsequent year. Decisions regarding continuation
awards and the funding level of such awards will be made after
consideration of such factors as the recipient's progress and
management practices, and the availability of funds. In all cases,
continuation awards require a determination by HHS that continued
funding is in the best interest of the Government.
(c) Neither the approval of any application nor the award of any
grant commits or obligates the United States in any way to make any
additional, supplemental, continuation, or other award with respect to
any approved application or portion of an approved application.
Sec. 59.9 For what purpose may grant funds be used?
Any funds granted under this subpart shall be expended solely for
the purpose for which the funds were granted in accordance with the
approved application and budget, the regulations of this subpart, the
terms and conditions of the award, and the applicable cost principles
prescribed in 45 CFR part 75.
Sec. 59.10 Confidentiality.
All information as to personal facts and circumstances obtained by
the project staff about individuals receiving services must be held
confidential and must 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. Otherwise, information may be disclosed only in
summary, statistical, or other form which does not identify particular
individuals. Reasonable efforts to collect charges without jeopardizing
client confidentiality must be made. Recipient must inform the client
of any potential for disclosure of their confidential health
information to policyholders where the policyholder is someone other
than the client.
Sec. 59.11 Additional conditions.
The Secretary may, with respect to any grant, impose additional
conditions prior to, at the time of, or during any award, when in the
Department's judgment these conditions are necessary to assure or
protect advancement of the approved program, the interests of public
health, or the proper use of grant funds.
Sec. 59.12 What other HHS regulations apply to grants under this
subpart?
Attention is drawn to the following the HHS regulations which apply
to grants under this subpart. These include:
Table 1 to Sec. 59.12
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37 CFR part 401........................ Rights to inventions made by
nonprofit organizations and
small business firms under
Government grants, contracts,
and cooperative agreements.
42 CFR part 50, subpart D.............. Public Health Service grant
appeals procedure.
45 CFR part 16......................... Procedures of the Departmental
Grant Appeals Board.
45 CFR part 75......................... Uniform Administrative
Requirements, Cost Principles,
and Audit Requirements for HHS
Awards.
45 CFR part 80......................... Nondiscrimination under
programs receiving Federal
assistance through the
Department of Health and Human
Services effectuation of Title
VI of the Civil Rights Act of
1964.
45 CFR part 84......................... Nondiscrimination on the basis
of handicap in programs and
activities receiving or
benefitting from Federal
financial assistance.
45 CFR part 87......................... Equal treatment for faith-based
organizations.
45 CFR part 91......................... Nondiscrimination on the basis
of age in HHS programs or
activities receiving Federal
financial assistance.
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[[Page 19833]]
[FR Doc. 2021-07762 Filed 4-14-21; 8:45 am]
BILLING CODE 4150-03-P
