Rule2021-21542
Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 7, 2021
Effective
November 8, 2021
Issuing agencies
Health and Human Services Department
Abstract
The Office of Population Affairs (OPA) in the Office of the Assistant Secretary for Health issues this final rule to revise the regulations that govern the Title X family planning program (authorized by Title X of the Public Health Service Act) by readopting the 2000 regulations, with several revisions to ensure access to equitable, affordable, client-centered, quality family planning services for clients, especially low-income clients. The effect of this 2021 final rule is to revoke the requirements of the 2019 regulations, including removing restrictions on nondirective options counseling and referrals for abortion services and eliminating requirements for strict physical and financial separation between abortion-related activities and Title X project activities, thereby reversing the negative public health consequences of the 2019 regulations. OPA also makes several revisions to the 2000 regulations to increase access to equitable, affordable, client-centered, quality family planning services.
Full Text
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[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Rules and Regulations]
[Pages 56144-56180]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21542]
[[Page 56143]]
Vol. 86
Thursday,
No. 192
October 7, 2021
Part IV
Department of Health and Human Services
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42 CFR Part 59
Ensuring Access to Equitable, Affordable, Client-Centered, Quality
Family Planning Services; Final Rule
Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 /
Rules and Regulations
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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 Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services (HHS).
ACTION: Final rule.
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SUMMARY: The Office of Population Affairs (OPA) in the Office of the
Assistant Secretary for Health issues this final rule to revise the
regulations that govern the Title X family planning program (authorized
by Title X of the Public Health Service Act) by readopting the 2000
regulations, with several revisions to ensure access to equitable,
affordable, client-centered, quality family planning services for
clients, especially low-income clients. The effect of this 2021 final
rule is to revoke the requirements of the 2019 regulations, including
removing restrictions on nondirective options counseling and referrals
for abortion services and eliminating requirements for strict physical
and financial separation between abortion-related activities and Title
X project activities, thereby reversing the negative public health
consequences of the 2019 regulations. OPA also makes several revisions
to the 2000 regulations to increase access to equitable, affordable,
client-centered, quality family planning services.
DATES: This rule is effective November 8, 2021.
FOR FURTHER INFORMATION CONTACT: Jessica Swafford Marcella, Deputy
Assistant Secretary for Population Affairs, Office of Population
Affairs, Office of the Assistant Secretary for Health, Department of
Health and Human Services, 200 Independence Avenue SW, Washington, DC
20201; email: <a href="/cdn-cgi/l/email-protection#2e644b5d5d474d4f00434f5c4d4b42424f6e46465d00494158"><span class="__cf_email__" data-cfemail="03496670706a60622d6e627160666f6f62436b6b702d646c75">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: As described in the 2021 Notice of Proposed
Rulemaking (NPRM) (86 FR 19812, April 15, 2021), the Department
proposed to revoke the 2019 Title X regulations (84 FR 7714, March 4,
2019) and readopt the 2000 regulations (65 FR 41270, July 3, 2000) with
14 revisions and 10 technical corrections. Revisions were proposed to
59.2, 59.5(a)(1), 59.5(a)(3), 59.5(a)(8), 59.5(a)(9), 59.5(a)(12),
59.5(a)(13), 59.5(b)(1), 59.5(b)(3), 59.5(b)(8), 59.6, 59.7, 59.10, and
59.11. Technical corrections were proposed to 59.2, 59.5(a)(4),
59.5(a)(5), 59.5(a)(6), 59.5(a)(7), 59.5(a)(11), 59.5(b)(3),
59.6(b)(2), 59.8, and 59.12. HHS received comments on all of the
revisions proposed in the NPRM, except the revision to 59.11. In
addition, the Department received comments on three of the 10 technical
corrections, including the technical corrections to 59.5(a)(4),
59.5(a)(5), and 59.12.
Based on the comments received in response to the NPRM, the
Department adopts eight of the revisions initially proposed in the NPRM
and nine of the technical corrections initially proposed in the NPRM as
final without additional changes. This includes the revisions to
59.5(a)(3), 59.5(a)(8), 59.5(a)(9), 59.5(b)(3), 59.5(b)(8), 59.6, 59.7,
and 59.11. This also includes the technical corrections to 59.2,
59.5(a)(4), 59.5(a)(5), 59.5(a)(6), 59.5(a)(7), 59.5(a)(11),
59.5(b)(3), 59.6(b)(2), and 59.8. Further, based on the comments
received in response to the NPRM and a subsequent, new interpretation
by the Department since the NPRM was issued, the final rule includes
nine additional revisions and six additional technical corrections to
what was proposed in the NPRM. The nine revisions include (a)
additional modifications to four of the provisions initially revised in
the NPRM (59.2, 59.5(a)(1), 59.5(b)(1), and 59.10); (b) additional
modifications to one of the provisions with a technical correction in
the NPRM (59.5(a)(4)); (c) removal of three of the revised provisions
in the NPRM (59.5(a)(12), 59.5(a)(13), and 59.12); and (d) revisions to
one provision not originally proposed for revision in the NPRM
(59.5(b)(6)). The six additional technical corrections include minor
clarifications to 59.2, 59.5(a)(1), 59.5(a)(4), and 59.6 and two
technical corrections to 59.5(b)(7) and 59.7 to reflect inclusive
language.
Detailed descriptions of all revisions, modifications, and
technical corrections are included later in this final rule. In
addition to revoking the 2019 rule, this final rule includes the
following revisions to the 2000 rule: Adding several new definitions;
requiring sites that do not offer a broad range of contraceptive
methods on-site to provide a prescription to the client for their
method of choice or referrals, as requested; requiring that family
planning services be client-centered, culturally and linguistically
appropriate, inclusive, trauma-informed, and capable of ensuring
equitable and quality service delivery; clarifying requirements around
billing practices and income verification; enabling a broader range of
clinical service providers to direct family planning services and to
provide consultation for medical services related to family planning;
clarifying the intent of community education; clarifying the purpose
and responsibilities of the Information and Education Advisory
Committee; including referral for primary healthcare providers;
expanding the grant review criteria to address equity; including
language to safeguard client confidentiality; and removing the list of
other applicable regulations from the regulatory text.
The Secretary of the Department of Health and Human Services (the
Secretary) issues the below regulations establishing requirements for
recipients of family planning services grants under section 1001 of the
Public Health Service (PHS) Act, 42 U.S.C. 300. The rules below adopt,
with the modifications described above, the regulations proposed for
public comment on April 15, 2021 at 86 FR 19812. They accordingly
revoke the 2019 final rule, Compliance with Statutory Program Integrity
Requirements, promulgated on March 4, 2019 (84 FR 7714).
Table of Contents
I. Background
II. Public Comment and Departmental Response
i. General Comments Related To Revoking 2019 Regulations and
Readopting the 2000 Regulations
A. Compliance With Section 1008 (42 U.S.C. 300a-6)
B. Data on Negative Public Health Consequences of 2019 Rule
C. Grantee and Subrecipient Compliance
D. Application of Conscience Statutes to Title X
E. Options Counseling
F. Subrecipient Nondiscrimination
G. Other Comments
ii. Comments Regarding Proposed Revisions and Technical
Corrections to the 2000 Regulation
A. Sec. 59.2. Definitions
B. Sec. 59.5(a)(1). Broad Range of Acceptable and Effective
Medically Approved Family Planning Methods and Services
C. Sec. 59.5(a)(3). Services are Client-Centered, Culturally
and Linguistically Appropriate, Inclusive, and Trauma-Informed;
Protect the Dignity of the Individual; and Ensure Equitable and
Quality Service Delivery Consistent With Nationally Recognized
Standards of Care
D. Sec. 59.5(a)(4). Services Do Not Discriminate Against any
Client Based on Religion, Race, Color, National Origin, Disability,
Age, Sex, Sexual Orientation, Gender Identity, Sex Characteristics,
Number of Pregnancies, or Marital Status
E. Sec. 59.5(a)(8). Charges for Services With a Schedule of
Discounts
F. Sec. 59.5(a)(9). Reasonable Measures To Verify Client Income
G. Sec. 59.5(a)(12). State Reporting Laws
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H. Sec. 59.5(a)(13). Subrecipient Monitoring
I. Sec. 59.5(b)(1) Provide Medical Services Related to Family
Planning
J. Sec. 59.5(b)(3) Community Education, Participation, and
Engagement
K. Sec. 59.5(b)(6) Services Under Direction of Clinical
Services Provider
L. Sec. 59.5(b)(8) Coordination and Use of Referrals and
Linkages
M. Sec. 59.6 Suitability of Informational and Educational
Material
N. Sec. 59.7 Grant Review Criteria
O. Sec. 59.10. Confidentiality
P. Sec. 59.12 Other Applicable Regulations
III. Regulatory Impact Analysis
i. Introduction
ii. Summary of Costs, Benefits, and Transfers
iii. Comments on the Preliminary Economic Analysis and Our
Responses
iv. Summary of Changes
v. Final Economic Analysis of Impacts
IV. Environmental Impact
V. Paperwork Reduction Act
VI. 2021 Final Rule Regulatory Text
I. Background
As discussed in the NPRM (86 FR 19812, April 15, 2021), in 2019,
the Secretary issued a final rule for the Title X program titled
Compliance with Statutory Program Integrity Requirements, which
substantially revised the longstanding polices and interpretations
defining what abortion-related activities were permissible under the
program, given Title X's statutory prohibition on abortion services.
That statutory prohibition, section 1008 (42 U.S.C. 300a-6), provides
that ``[n]one of the funds appropriated under this title shall be used
in programs where abortion is a method of family planning.'' The 2000
regulations, which were in effect prior to the 2019 regulations and
which reflected compliance standards that had been in effect for nearly
the entirety of the Title X program, had been widely accepted by
grantees, had enabled the Title X program to operate successfully, and
had not resulted in any litigation.
The rules issued on March 4, 2019 (84 FR 7714): (1) Required strict
physical and financial separation between abortion-related activities
and Title X project activities, (2) required significant reporting by
Title X grantees in grant applications and required reports about all
subrecipients, referral agencies, or other partners who receive Title X
funds, (3) removed the requirement for pregnancy options counseling
upon request and permitted nondirective counseling only by an advanced
practice provider, (4) prohibited Title X-funded entities from
referring for abortion, while requiring referral for prenatal care,
regardless of a client's request, and (5) required providers to
maintain detailed records on adolescent clients, including age of their
sexual partners and specific actions taken to encourage family
participation.
In the 2019 rule, the Department stated that it ``believes the
provisions of this final rule provide much needed clarity regarding the
Title X program's role as a family planning program that is statutorily
forbidden from paying for abortion and funding programs/projects where
abortion is a method of family planning. The Department believes that
the 2000 regulations fostered an environment of ambiguity surrounding
appropriate Title X activities.'' 84 FR at 7721 (March 24, 2019). This
belief about the ambiguity, however, lacked any specific evidence. OPA
closely monitors Title X grantee compliance through regular grant
reports, compliance monitoring visits, and legally required audits, and
it has done so since the beginning of the program. Close oversight of
Title X grantees for decades uncovered no misallocation of Title X
funds by grantees. OPA oversight did identify occasional instances
where grantees were in need of updating their written policies to
clearly reflect the Title X statutory language, but OPA never found any
instance where grantees were co-mingling funds with activities not
allowed under the statute or regulations.
In response to concerns that the 2019 rule imposed undue and
improper restrictions on grantees, the Department recently conducted a
fresh review of the factual assertions that accompanied that rule. In
particular, the Department carefully reviewed over 30 Government
Accountability Office (GAO), Office of the Inspector General (OIG), and
Congressional Research Service (CRS) reports involving the Title X
program from 1975 to 2021. Directly contradicting the factual
assertions accompanying the 2019 rule, that recent review found only
minor compliance issues with grantees--and those only in two GAO
reports from the 1980s. Those two reports 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 (July 3, 2000). While those forty-year-old 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.'' Since those reports, there has been no
evidence of compliance issues regarding section 1008 by Title X
grantees that would justify the greatly increased compliance costs for
grantees and oversight costs for the federal government the 2019 rule
required. Experience under the 2019 rule has only underscored these
concerns. Based on that experience--which was not and could not have
been available to the Department at the time the 2019 rule was
promulgated--we have determined that the 2019 rule has led to a
diversion of funds from the core purpose of Title X: To provide a broad
range of family planning services. Those funds are now being spent on
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, and in some instances they are inconsistent with nationally
recognized standards of care.
The significant negative public health consequences of the March 4,
2019 rule have become clear over the past two years, and the rule was
extremely controversial from the beginning. The rule was immediately
challenged in several district courts by 22 states and the District of
Columbia, the American Medical Association, Title X grantee
organizations, and individual grantees, with support from major medical
organizations, including the American College of Obstetricians and
Gynecologists, the American Academy of Pediatrics, the American Academy
of Family Physicians, the Society for Adolescent Health and Medicine,
and the Society for Maternal-Fetal Medicine. The 2019 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 v. Sullivan, 500 U.S.
173 (1991) in upholding the rule. A majority of the en banc panel
found, consistent with Rust, that the Department ``could'' interpret
section 1008 as it did in the 2019 rule, and that 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
[[Page 56146]]
Circuit also held that the 2019 rule violated an annual appropriations
rider requiring nondirective counseling, the non-directive mandate.\1\
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\1\ Both circuit courts also differed on the permissibility of
the rule under section 1554 of the Affordable Care Act.
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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.
While courts and judges were split on the ultimate legality of the
2019 rule, evidence of the negative public health consequences of the
rule quickly became clear, and significant. After the implementation of
the 2019 rule, 19 Title X grantees out of 90 total grantees withdrew
from the program. The 19 grantees that withdrew from the Title X
program included 11 State Departments of Health and independent Family
Planning Associations and eight Planned Parenthood organizations.\2\
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\2\ Withdrawn grantees included (1) Family Planning Association
of Maine, Inc., (2) Hawaii Department of Health, (3) Health
Imperatives, Inc. (MA), (4) Illinois Department of Health, (5)
Maryland Department of Health, (6) Massachusetts Department of
Public Health, (7) Oregon Health Authority, (8) Planned Parenthood
Association of Utah, (9) Planned Parenthood Minnesota, North Dakota,
South Dakota, (10 & 11) Planned Parenthood of Great Northwest & the
Hawaiian Islands (two separate grants), (12) Planned Parenthood of
Greater Ohio, (13) Planned Parenthood of Illinois, (14) Planned
Parenthood of Northern New England, (15) Planned Parenthood of
Southern New England, (16) Public Health Solutions (NY), (17) New
York Department of Health, (18) Vermont Agency of Human Services,
and (19) Washington State Department of Health.
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These organizations made clear to the Department in formal
correspondence that they relinquished their grants out of concern that
the 2019 rule interfered with the patient-provider relationship and
compromised their ability to provide quality healthcare to all clients.
One organization commented that ``the Final Rule makes it impossible
for us to provide healthcare and information to patients consistent
with medical ethics and evidence-based standards of care.'' Another
organization stated that the 2019 rule ``would fundamentally compromise
the relationship our patients have with us as trusted providers of this
most personal and private healthcare.'' Another organization said that
``the new regulations interfere with a healthcare provider's ability to
provide healthcare in accordance with accepted standards of care for
reproductive health.'' Still another said, ``these new rules require
our providers to deprive their patients of the information and services
they need to make and carry out fully informed decisions about their
reproductive health. Our providers' ethical and professional
responsibilities do not allow this.'' Although it might have been
possible, at the time the 2019 rule was promulgated, to predict that
providers would withdraw, any such prediction would have been
uncertain. That so many providers did in fact withdraw from the program
is a change in circumstances that, in the Department's view, demands
reconsideration of the 2019 rule.
In addition to the grantees that withdrew from Title X completely,
many other grantees that continued to receive Title X funding had
subrecipients and service sites within their existing networks withdraw
from the program. Overall, 19 grantees, including 231 subrecipients and
945 service sites, withdrew from the Title X program shortly after the
rule took effect. Additionally, 18 grantees that continued in the
program reported losses to their service network (i.e., exiting
subrecipients) because of the 2019 final rule. As a result, the Title X
program provided services to 844,083 fewer clients in 2019 compared to
2018.\3\ Comparing Family Planning Annual Report (FPAR) data for 2018
and 2019, OPA estimates that 94% (or 789,960) of the total decrease
(844,083) in clients can be attributed to the 2019 rule. A total of 41
states and two territories saw a decrease in clients served in 2019
compared to 2018. Of those, seven saw a decline of more than 40 percent
in clients served (AK, HI, MD, UT, VT, WI, and WV), seven saw a decline
of 31-40 percent (CA, CT, ME, MN, NH, NM, and NY), seven saw a decline
of 21-30 percent (AZ, IL, MA, MT, NJ, OR, and WA), seven saw a decline
of 11-20 percent (IA, IN, MI, OH, PA, VA, and the Marshall Islands),
nine saw a decline of 5-10 percent (AL, AR, KY, NE, NC, ND, SC, TN, and
WY), and six saw a decline of five percent or less (DE, CO, LA, OK, SD,
and the U.S. Virgin Islands). Only nine states, six territories and the
District of Columbia saw their number of clients served stay the same
(FL, KS, MO, RI, and TX) between 2018 and 2019 (<plus-minus>1%) or
increase (GA, ID, MS, NV, six territories, and DC), with the majority
experiencing a small annual increase of between 70 to 3,000 clients.
Minor fluctuations notwithstanding, 789,960 fewer clients were served,
which had a disproportionate impact on minority clients, adolescent
clients, lower-income individuals, and those without insurance--all
outcomes directly attributable to the 2019 rule. Most concerningly,
there are six states that formerly had Title X services that currently
have no Title X services available (HI, ME, OR, UT, VT, and WA) and
seven states with Title X services available on a very limited basis
(AK, CT, IL, MA, MN, NH, and NY). The Department believes that these
stark facts, which became clear only after the promulgation of the 2019
rule, justify reconsideration of that rule.
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\3\ (OPA, 2020). Family Planning Annual Report: 2019 National
Summary Report. Accessed on March 9, 2021 from <a href="https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf">https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf</a>.
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To ensure continuity of services and maintain a safe environment
for clients and staff during the pandemic, Title X providers followed
guidance issued by the Centers for Disease Control and Prevention
(CDC), OPA, and others to manage supply and staffing shortages, and
they implemented creative strategies tailored to their circumstances
and clientele (virtual telehealth, for example). Despite these efforts,
in 2020 vs. 2019, Title X had 193 fewer subrecipients (867 vs. 1,060)
and 794 fewer service sites (3,031 vs. 3,825). The decrease in the size
of the Title X service network appears to have substantially reduced
the availability of and, consequently, access to Title X services. In
2020, Title X served 1.6 million fewer family planning users than in
2019 (1.5 million vs. 3.1 million), and Title X service sites delivered
care to 302 fewer users per site (507 vs. 809). Furthermore, in 2020,
Title X conducted almost 2.0 million fewer family planning encounters
than in 2019 (2.7 million vs. 4.7 million). While the 2020 data
undoubtedly reflect the public health emergency related to the COVID-19
pandemic, the pattern of the losses in the program initiated by the
2019 rule was exacerbated in 2020 for an already disrupted and weakened
network.
Of additional concern, the 2019 rule has had a disproportionate
impact on low-income clients, who are precisely the population that the
Title X program was established to serve. The 2019 rule has
significantly decreased the number of low-income, uninsured, and racial
and ethnic minorities accessing Title X services. Following
implementation of the 2019 rule, 573,650 fewer clients under 100
percent of the federal poverty level (FPL); 139,801 fewer clients
between 101 percent FPL to 150 percent FPL; 65,735 fewer clients
between 151 percent FPL and 200 percent FPL; and 30,194 fewer clients
between 201 percent FPL to 250 percent FPL received Title X services.
This contradicts the purpose and intent of the Title X program, which
is to prioritize and
[[Page 56147]]
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
Black or 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.\4\
Additionally, 151,375 fewer adolescent clients received essential
family planning services in 2019. The Department believes these new
facts warrant a reconsideration of the 2019 rule.
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\4\ (OPA, 2020). Family Planning Annual Report: 2019 National
Summary Report. Accessed on March 9, 2021 from <a href="https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf">https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf</a>.
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The mandate of the Title X program is to support access to critical
family planning and preventive health services; unfortunately, the
result of the 2019 rule ran counter to that effort. The 2019 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 sexually
transmitted infections (STIs). More specifically, in 2019 compared 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). 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. 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.\5\
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\5\ (OPA, 2020). Family Planning Annual Report: 2019 National
Summary Report. Accessed on March 9, 2021 from <a href="https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf">https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf</a>.
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In the 2019 rule, the Department stated that the rule was
``expected to increase the number of entities interested in
participating in Title X as grantees or subrecipient service providers
and, thereby, to increase patient access to family planning services
focused on optimal health outcomes for every Title X client.'' 84 FR at
7782 (March 24, 2019). However, this expectation proved unwarranted.
Despite several attempts, OPA has been unable to recruit new grantees
and new providers into the Title X program to fill the current gaps in
services resulting from implementation of the 2019 rule. First, OPA
issued competitive supplemental funding of $33.7 million to 50 existing
Title X grantees in fiscal year 2019 to expand their Title X services.
Unfortunately, even with the additional funding, the majority of states
were not able to increase the number of service sites in their Title X
networks. From 2018 to 2020, 38 states and territories saw a decrease
in the number of service sites in their networks, 12 saw no change in
their number of service sites, and only nine saw an increase in the
number of service sites. Analyzing users between 2018-2020 for those
nine states that gained service sites, six still lost users (WV, AZ,
DE, NE, CO, and TX) while three gained users (GA, NV, and Palau). Next,
OPA issued a competitive funding announcement in fiscal year 2020 to
recruit new grantees to provide Title X services in unserved or
underserved states and communities. The number of applications received
was so low (eight 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 OPA was
only able to fund grantees to provide services in three states with no
or limited Title X services at the time.
The lack of organizations applying for Title X grant funding
following implementation of the 2019 rule and the lack of new service
sites willing to join existing Title X grantees as providers strongly
suggest that the Department was wrong to believe that the 2019 rule
would increase the number of grantees and providers. Rather, the 2019
rule appears to have had the opposite effect and resulted in a
significant loss of grantees, subrecipients, and service sites, and
close to one million fewer clients served from 2018 to 2019. The
Department believes that this record warrants a change in course.
The decline in clients served and services provided is devastating.
The Title X program is the only federal grant program dedicated to
providing comprehensive family planning and related preventive health
services. Title X clinics provide services to clients, with priority
given to persons from low-income families. Title X services are
voluntary, confidential, and provided regardless of one's ability to
pay. For many clients, Title X clinics are their only ongoing source of
healthcare and health education. In fact, six in 10 women who go to a
publicly funded family planning clinic consider it their usual source
of medical care.\6\
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\6\ Frost, J., Gold., Hasstedt, K., & Sonfield, A. (2014).
Moving Forward: Family Planning in the Era of Health Reform. New
York: Guttmacher Institute.
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While some family planning providers that withdrew from the Title X
program were able to continue providing reproductive health services at
some level in the absence of Title X funding, the services provided
were not the same as those provided under Title X. Grantees that
relinquished their Title X funding at the time made clear that they
were not able to provide the same breadth of services as they had been
able to under Title X and were not able to provide services using the
same schedule of discounts as required in the Title X program.
According to several comments received, the loss of Title X funding
meant that organizations had to adjust their fee schedules and push
more costs for services to the clients. As a result, organizations saw
more clients forgoing recommended tests, lab work, STI testing,
clinical breast exams, and pap tests. Further, due to costs,
organizations saw some family planning clients outside of the Title X
network choose less effective methods of birth control.
The 2019 rule abandoned major portions of Providing Quality Family
Planning Services: Recommendations from Centers for Disease Control and
Prevention and the U.S. Office of Population Affairs (QFP),\7\ such as
nondirective options counseling and referrals, and the client-centered
approach recommended by QFP, over the objection of every major medical
organization and without any countervailing public health rationale.
QFP recommendations support providers in delivering quality family
planning services and define family planning services within a broad
context of preventive services, to improve health outcomes for
individuals and their (future) children. QFP recommendations are based
on a rigorous, systematic, and transparent review of the evidence and
were developed with input from a broad range of clinical experts, OPA,
and the CDC. These recommendations not only improve the quality of care
provided to family planning clients, but they foster a supportive and
communicative relationship between provider and patient. As evident
from grantee relinquishment letters and comments
[[Page 56148]]
received in response to the 2021 NPRM, abandoning major portions of
this approach has damaged the patient-provider relationship. Moreover,
the 2019 rule required prenatal referral even if the patient objected,
an approach which also does not comport with well-accepted public
health and clinical care principles.
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\7\ CDC. (2014). Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs.
Accessed on March 8, 2021 from <a href="https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning">https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning</a>.
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On January 28, 2021, President Biden issued a ``Memorandum on
Protecting Women's Health at Home and Abroad.'' \8\ The Memorandum
stated that ``[w]omen should have access to the healthcare they need.
For too many women today, both at home and abroad, that is not
possible. Undue restrictions on the use of Federal funds have made it
harder for women to obtain necessary healthcare. The Federal Government
must take action to ensure that women at home and around the world are
able to access complete medical information, including with respect to
their reproductive health.'' The Memorandum then instructed the
Department to ``review the Title X Rule and any other regulations
governing the Title X program that impose undue restrictions on the use
of Federal funds or women's access to complete medical information and
shall consider, as soon as practicable, whether to suspend, revise, or
rescind, or publish for notice and comment proposed rules suspending,
revising, or rescinding, those regulations, consistent with applicable
law, including the Administrative Procedure Act.''
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\8\ Available at <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/28/memorandum-on-protecting-womens-health-at-home-and-abroad/">https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/28/memorandum-on-protecting-womens-health-at-home-and-abroad/</a>.
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HHS reviewed the 2019 regulations pursuant to the President's
memorandum. Following this review, on April 15, 2021, the Department
issued a Notice of Proposed Rulemaking (NPRM) for public comment (86 FR
19812, April 15, 2021), proposing rules to revise the 2019 regulation
by essentially readopting the 2000 regulations. 65 FR 41270 (July 3,
2000). The 2000 regulations were consistent with applicable statutory
commands, were widely accepted by grantees, enabled the Title X program
to operate successfully, and led to no litigation over their
permissibility.
Based on the evidence that has emerged since the adoption of the
2019 rule, as well as a fresh consideration of the evidence that
existed at the time, the negative public health consequences of the
2019 rule are clear. The rule dramatically reduced access to family
planning and preventive health services that are essential for hundreds
of thousands of clients, especially for the low-income clients Title X
was specifically created to serve. The 2019 rule decreased the number
of providers willing to participate in the Title X program, further
reducing access to family planning services within states across the
country and in rural and urban communities alike. The 2019 rule shifted
the Title X program away from its history of providing client-centered
quality family planning services and instead set limits on the patient-
provider relationship and the information that could be provided to the
patient by the provider. The 2019 rule resulted in increased costs for
grantee reporting that are unnecessary for ensuring grantee compliance.
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 and other disproportionately impacted
communities, such as those in rural regions, minority clients, and
adolescent clients, are relegated to inferior access. The populations
served by Title X may already face health inequities driven by
financial and access barriers to quality care that would be exacerbated
by continuing to allow limited or delayed healthcare choices and biased
or insufficient healthcare information. Given that so many individuals
depend on the Title X program as their primary source of healthcare,
the Department recognizes that this is a situation that must be
rectified with urgency in the interest of public health and equity.
Most importantly, in readopting the 2000 rule, this final rule
removes the strict physical separation requirements that were imposed
on top of existing obligations for separation between abortion services
and Title X project related activities. It also allows Title X
providers to provide truly nondirective counseling and refer their
patients for all services desired by the client, including abortion
services. The 2000 regulations successfully governed the Title X
program for decades and were widely accepted by grantees.
The 2019 rule imposed an interrelated set of requirements that are
difficult to disentangle provision by provision. For example,
59.5(a)(5) prohibited funded projects from providing, promoting,
referring, or supporting abortion as a method of family planning.
Section 59.13 concurrently required assurance that a project did not
``include abortion as a method of family planning'' backed by
documentary evidence of Subsections 59.14-59.16. The interrelatedness
of these requirements was underscored by 59.7(b) requiring applicants
to ``clearly address how the proposal will satisfy the requirements of
the regulation,'' before even proceeding to competitive consideration.
Most of the 2019 provisions did not function independently of each
other.
The Department did initially propose keeping portions of two
provisions from the 2019 rule regarding compliance reporting
(59.5(a)(12)) on state sexual abuse notification laws and subrecipient
monitoring (59.5(a)(13)). As further explained below, these provisions
created administrative costs for grantees and the government with no
measurable benefits. These provisions, like the entire 2019 rule,
depended on assumptions about how the program should work and grantee
compliance even with no evidence of grantee non-compliance.
Given these considerations, the Department has determined that the
most appropriate course is to revoke the 2019 rule in its totality.
Every court to rule on the 2019 rule also believed that all of its
provisions were of a piece and either struck down or upheld the rule in
its entirety. See, e.g., Mayor of Baltimore v. Azar, 973 F3d 258, 292
(4th Cir. 2020) (``Despite the severability clause, the Final Rule is
not severable because it is clear HHS `intended the [Final Rule] to
stand or fall as a whole,' and the agency desired `a single, coherent
policy, the predominant purpose of which' is to reinstitute the 1988
Rule.'').
As compared to the 2019 rule, new provisions added to the re-
adoption of the 2000 rule operate independently of each other--and the
2000 rule--to enhance the program. Particularly as the program operated
for decades under the 2000 rule, the 2021 additions are severable from
the 2000 rule. For example, while adding to the statutory goals of
reaching low-income and underserved individuals, if the added grant
evaluation criteria of equity, 59.7(a)(3), was excised, the program
could still accomplish its mission successfully using the 2000 criteria
alone. And, were a court to strike down the new income verification
measures in 59.5(a)(9), the program would be able to accomplish its
mission using the 2000 criteria alone.
In addition to readopting the requirements as they existed prior to
the 2019 rule, the 2021 rule also includes several revisions that will
strengthen the Title X program and ensure access to equitable,
affordable, client-centered, quality family planning services for all
clients, especially for low-income clients, while retaining the
longstanding prohibition on directly promoting or performing abortion
that follows from
[[Page 56149]]
Section 1008's text and subsequent appropriations enactments.
Advancing equity for all, including people from low-income
families, people of color, and others who have been historically
underserved, marginalized, and adversely affected by persistent poverty
and inequality, is a priority for the Department, for OPA, and for the
Title X program. By focusing on advancing equity in the Title X
program, we can create opportunities to support communities that have
been historically underserved, which benefits everyone. The 2021 rule
was written to ensure that the predominantly low-income clients who
rely on Title X services as their usual source of medical care have
access to the same quality healthcare, including full medical
information and referrals, that higher-income clients and clients with
private insurance are able to access. Key strategies for advancing
equity include removing barriers to accessing services, improving the
quality of services, and providing services that are client-centered.
Several revisions in the rule focus on improving access to services.
These revisions include clearly defining what constitutes a broad range
of acceptable and effective family planning methods and services,
requiring service sites not offering a broad range of methods on-site
to provide a prescription to the client for their method of choice or
referrals, as requested, clarifying required billing practices and
income verification for low-income clients, enabling a broader range of
clinical services providers to direct Title X services and to provide
consultation for medical services, and strengthening client
confidentiality.
Several revisions in the 2021 rule focus on improving quality of
Title X services. These revisions include clearly defining quality
healthcare as safe, effective, client-centered, timely, efficient, and
equitable; incorporating QFP's definition of family planning into the
regulation; and requiring all family planning services to be delivered
consistent with nationally recognized standards of care. Finally,
several revisions in the 2021 rule focus on ensuring client-centered
care. These revisions include clearly defining client-centered care as
being respectful of, and responsive to, individual client preferences,
needs, and values and where client values guide all clinical decisions,
and requiring all family planning services to be client-centered,
culturally and linguistically appropriate, inclusive, and trauma-
informed.
II. Public Comment and Departmental Response
The Department provided a 30-day public comment period for the
proposed rule. That period closed on May 17, 2021. A total of 180,266
public comments were submitted to <a href="http://www.Regulations.gov">www.Regulations.gov</a> or directly to
the Department.
With this 2021 final rule, the Department revokes the requirements
of the 2019 regulations (84 FR 7714, March 24, 2019) and readopts the
2000 regulations (65 FR 41270, July 3, 2000) with several revisions. In
the section below, the Department discusses the public comments, its
responses, and the text of the final rules. The Department first
presents a summary of public comments received related to revoking the
2019 regulation and readopting the 2000 regulation. The Department then
provides a summary of comments received regarding the revisions and
technical corrections proposed in the NPRM to specific provisions of
the 2000 regulations. The NPRM proposed 14 revisions, including to
59.2, 59.5(a)(1), 59.5(a)(3), 59.5(a)(8), 59.5(a)(9), 59.5(a)(12),
59.5(a)(13), 59.5(b)(1), 59.5(b)(3), 59.5(b)(8), 59.6, 59.7, 59.10, and
59.11. The NPRM also proposed 10 technical corrections, including to
59.2, 59.5(a)(4), 59.5(a)(5), 59.5(a)(6), 59.5(a)(7), 59.5(a)(11),
59.5(b)(3), 59.6(b)(2), 59.8, and 59.12. The Department received
comments on all the revisions proposed in the NPRM and three of the 10
technical corrections. The Department did not receive comments on the
revision to 59.11, nor to the technical corrections to 59.2,
59.5(a)(6), 59.5(a)(7), 59.5(a)(11), 59.5(b)(2), 59.5(b)(3), or 59.8. A
summary of comments and the Department's response are only provided for
those revisions and technical corrections that received comments. In
addition, the Department received public comments requesting a revision
to 59.5(b)(6) that was not proposed in the NPRM, but that is related to
the revision that was proposed in the NPRM to 59.5(b)(1). A summary of
these comments and the Department's response are also included below.
After considering the comments, the Department adopts the
regulations proposed for public comment on April 15, 2021 at 86 FR
19812 with nine additional revisions and six additional technical
corrections to what was proposed in the NPRM.
General Comments Related To Revoking 2019 Regulations and Readopting
the 2000 Regulations
A. Compliance With Section 1008 (42 U.S.C. 300a-6)
Comments: Thousands of comments expressed concern that the
program's returning to the 2000 regulations violated both the Title X
statute and the Court's holding in Rust v. Sullivan, 500 U.S. 173
(1991). Many comments stated referral for abortion ``squarely''
violated the ``plain'' ``clear'' text of section 1008. Many of these
same comments also asserted the statute requires separation from
abortion activities because they are programs ``where'' abortion is a
method of family planning. Both comments believing the 2000 rule to be
unlawful, and those affirming it to be lawful, cited Rust as well as
legislative history in making their arguments.
Those opposing the proposed rule also stressed that private
organizations have no right to federal funding, much less to federal
funding to perform abortions. These comments stated that ``[m]oney is
fungible,'' and reverting to the 2000 rule will create so-called
``slush funds'' and infrastructure for organizations to perform
abortions in violation of section 1008. They also suggested that the
2000 rule lacked any mechanism to ensure compliance with the statute,
and that the NPRM, in fact, violates the statute because the proposed
definition of ``family planning'' includes related ``pregnancy
counseling'' which requires referral for abortion when requested
(59.5(a)(5)). Many comments asserted that revoking the 2019 rule would
allow grantees to engage in lobbying and other activities encouraging
abortion that violate section 1008.
Response: As stated in the NPRM, the Supreme Court held in Rust:
``[W]e agree with every court to have addressed the issue that the
language is ambiguous. The language of Sec. 1008--that `none of the
funds appropriated under this subchapter shall be used in programs
where abortion is a method of family planning'--does not speak directly
to the issues of counseling, referral, advocacy, or program
integrity.'' Rust at 184. No court adjudicating the 2019 rule found
that the separation, referral, or other requirements were required by
Rust. Such a finding would be contrary to the primary holding in Rust.
Counseling for abortion, including referral when requested, has never
been held to constitute a violation of section 1008.
Interpreting section 1008 to prohibit referrals and require strict
separation would also be inconsistent with nearly
[[Page 56150]]
40 years of agency practice under the program across numerous
administrations. Such an interpretation would also appear contrary to
decades of close Congressional oversight, including annual Title X
appropriations riders, and a specific annual line item appropriation
through which Congress can be--and has been--quite clear as to how the
agency should operate.
In readopting the 2000 rule, the program is also reinstating
interpretations and policies under section 1008 of the statute that
were in place for much of the program's history and published in the
Federal Register in 2000. 65 FR 41281 (July 3, 2000). Those program
policies discuss, for example, the requirements for separation:
``Separation of Title X from abortion activities does not require
separate grantees or even a separate health facility, but separate
bookkeeping entries alone will not satisfy the spirit of the law. Mere
technical allocation of funds, attributing federal dollars to non-
abortion activities, is not a legally supportable avoidance of section
1008.'' 65 FR at 41282 (July 3, 2000). Also, ``[w]hile a Title X
project may provide a referral for abortion, which may include
providing a patient with the name, address, telephone number, and other
relevant factual information (such as whether the provider accepts
Medicaid, charges, etc.) about an abortion provider, the project may
not take further affirmative action (such as negotiating a fee
reduction, making an appointment, providing transportation) to secure
abortion services for the patient.'' 65 FR at 41281 (July 3, 2000).
Finally, while a Title X project may not advocate for abortion as a
method of family planning, it ``may be a dues paying participant in a
national abortion advocacy organization, so long as there are other
legitimate program-related reasons for the affiliation (such as access
to certain information or data useful to the Title X project).'' Id.
Interested entities are encouraged to consult this notice.
The Department agrees that it is not under a duty to subsidize
abortion. It does not do so, and it is prohibited from doing so. As
discussed in the NPRM, legislative history and longstanding
appropriations riders prohibit Title X funds from being expended on
abortion. See, e.g., Consolidated Appropriations Act, 2021, Public Law
116-260, Div. H, sec. 207, 134 Stat. 1182, 1590. More generally,
Section 507 of the Consolidated Appropriations Act, 2021 prohibits
federal funds from being used for abortion except for cases of rape,
incest, or maternal health. Id. at sec. 507. As discussed in the NPRM
and above, the Department employs a variety of mechanisms to enforce
such restrictions, such as regular grant reports, compliance monitoring
visits, third-party audits, compliance guidance, and grantee education.
None of these oversight tools have uncovered any more than minimal
problems with grantee compliance under section 1008.
The Department also agrees that no particular private organizations
have a right to Title X funding. The program is returning to the
program requirements in operation for the majority of its history
because those requirements best serve individual clients and the public
health. In the wake of the 2019 rule, both private organizations and
states withdrew from the program, leaving multiple states without any
Title X providers and the agency struggling to meet its mandate to
provide family planning services for low-income populations in areas of
high need. Though in some places organizations and jurisdictions were
able to temporarily provide resources to replace the loss of Title X
funds, providers were not always able to provide the same scope of
services or seamless care coordination that Title X projects can
provide. Public comments from those organizations made clear that they
were not able to provide the same breadth of services, nor were they
able to provide services with the same schedule of discounts for low-
income clients.
The Department disagrees that Title X grant funds allow for the
``creation of slush funds'' or that those funds are ``fungible.'' As
stated above, the Department has multiple methods by which it confirms
that grant funds are spent for grant purposes, and it has concluded
that grantees comply, not just with section 1008, but with
Congressional directives and other requirements of the program. Again,
the 2019 rule could point to no significant compliance issues related
to the diversion of Title X grant funds, and a fresh review of decades
of evidence has uncovered no such issues. A ban on organizations
receiving Title X funds for lawful activities outside of the Title X
project would go beyond the 2019 rule and raise serious constitutional
issues. And even if such a restriction might conceivably be lawful, the
Department clearly has the discretion to open eligibility to the most
qualified Title X providers.\9\
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\9\ Zolna, M.R., & Frost, J.J. (2017, August 2). Publicly funded
family planning clinics in 2015: Patterns and trends in service
delivery practices and protocols. Guttmacher Institute. Retrieved
from <a href="https://www.guttmacher.org/report/publicly-funded-family-planning-clinic-survey-2015">https://www.guttmacher.org/report/publicly-funded-family-planning-clinic-survey-2015</a>.
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B. Data on Negative Public Health Consequences of 2019 Rule
Comments: A few comments took issue with data presented in the
NPRM. They stated that the Department used flawed data and failed to
account for the effects of COVID-19, instead attributing the loss of
grantees and subrecipients and the decline in services to the 2019
rule. One comment stated that the Department does not have data to
assess the effect of the 2019 rule. Another comment argued that the
decline in clients served is the result of a long time decline since
the 2000 rule. One of those same comments reflected the belief that the
decline in services is instead related to changes in insurance, changes
in poverty, and use of the most effective contraceptive methods, and
that declines have been continuous since 2000.
Some of the comments also took issue with the Department's position
that the withdrawal of grantees from the program in response to the
2019 rule resulted in a decline in services, as they stated those
services were continued with state and private funds and not
discontinued, and the Department's claims of fewer services provided is
``a red herring.'' The same comment pointed out the proposed rule noted
that seven states saw an increase in clients after the 2019 rule.
Another comment cited Planned Parenthood data showing that Planned
Parenthood provided more services in 2020 compared to 2019 and that
other providers stepped in to fill the gaps in services left when
Planned Parenthood exited the Title X program. It cited Ohio as an
example and said that additional clients would be served post-COVID-19.
A final opposing comment claimed that the number of new providers
applying for Title X funds increased after the publication of the 2019
rule.
In contrast, numerous comments supported the 2021 NPRM and shared
data on the negative impact that the 2019 rule has had in their states
and communities, reinforcing the Department's statements in the NPRM.
Many of the comments spoke to the drastic reduction in clients they
were able to serve after the 2019 regulation. One comment stated,
``throughout the history of Title X, since its inception in 1970, there
has never been as sharp a decline in the number of patients served by
the program as occurred between 2018 and 2019.'' More than losing
numbers of clients, numerous comments spoke to the types of clients
they have not been able to serve and the nature of services that are
being lost because clients cannot afford those services.
[[Page 56151]]
Several comments noted that the 2019 regulation is disproportionately
impacting rural regions, minority clients, adolescent clients, lower-
income individuals, and those without insurance, particularly in states
that have not expanded Medicaid.
Contrary to the comments that expressed Planned Parenthood
affiliates were able to provide more services after leaving the Title X
program, Planned Parenthood affiliates themselves, in addition to other
commenters, indicated that without Title X funding, they have had to
adjust their sliding fee scales, pushing more costs onto the clients.
Comments stated that this has resulted in clients forgoing recommended
tests, lab work, STI testing, clinical breast exams, and Pap tests in
large numbers. Further, these comments provided evidence that some
clients are choosing less effective methods of birth control due to
costs. Other comments stated that the changes in fees have pushed their
clients into seeking care elsewhere, interrupting their continuity of
care. One comment reported that the loss of Title X funding resulted in
loss of eligibility for the 340B Drug Pricing Program, requiring the
agency to dispose of contraceptive methods purchased under the 340B
Program and repurchasing them at higher market prices.
The Attorneys General of 22 states and the District of Columbia
commented that the emergency, one-time,\10\ and private funding made
available to replace the loss of Title X funding has strained state
budgets and could not be sustained, creating uncertainty for the future
of their family planning providers. Additionally, several comments
noted that the fundraising activities necessitated after leaving the
Title X program have come at a cost and have resulted in providers
having to scale back or eliminate educational and outreach programs in
many states. Other comments noted that it was extremely burdensome to
try to identify and recruit additional providers to fill the gaps left
after the 2019 rule. Many commenters expressed strong interest in
rejoining the Title X network once the current rule is replaced.
Finally, several states reported that while their efforts were
refocused on recruiting and onboarding new providers into their Title X
network under the 2019 rule, they faced much resistance and/or a lack
of interest, and their provider networks did not increase under this
rule, continuing to adversely impact the communities they serve.
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\10\ States that provided emergency funding include CA, MA, MD,
NY, OR, WA, and VT.
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Response: The Department believes that the negative public health
consequences of the 2019 rule are clear. The rule dramatically reduced
access to essential family planning and related preventive health
services for hundreds of thousands of clients, especially for the low-
income clients Title X was specifically created to serve. The 2019 rule
decreased the number of providers willing to participate in the Title X
program, further reducing access to essential family planning services
within states and communities across the country.
The Department disagrees that the data cannot distinguish between
enactment of the 2019 rule and the pandemic. The 2019 rule officially
took effect mid-year in 2019, but COVID-19 was not announced as a
national emergency until early 2020. The Department has data to assess
the impact of the 2019 rule through FPAR and grantee progress reports,
including data on the decrease in the number of clients served in 2019
when the rule was in place and prior to COVID-19. As stated in the
Background section, 19 grantees, 231 subrecipients, and 945 service
sites immediately withdrew from the Title X program. As a result, the
Title X program provided services to 844,083 fewer clients in 2019
compared to 2018, prior to the implementation of the 2019 rule,
approximately a 22 percent decrease. A total of 41 states and two
territories saw a decrease in clients served in 2019 compared to 2018;
five states saw their number of clients served stay the same; and four
states, five territories, and the District of Columbia saw an increase
in clients served from 2018 to 2019, with the majority experiencing a
small annual increase of between 70 to 3,000 clients. Minor
fluctuations notwithstanding, 844,083 fewer clients were served,
disproportionately impacting lower-income individuals, minority
clients, adolescent clients, and those without insurance. There are
currently six states with no Title X services available and seven
states with Title X services available on a very limited basis.
Ultimately, the hundreds of thousands of clients who lost access to
Title X services as a result of the 2019 rule lost access to critical
family planning and preventive health services. As noted in the
background, this included declines in contraceptive services, Pap
tests, clinical breast exams, and HIV and STI testing.
The Department agrees that a few states were able to increase their
service sites following the 2019 rule, but these are the exception.
From 2018 to 2020, 34 states and territories saw a decrease in the
number of service sites in their network, 18 saw no real change in
their number of services sites, and only seven saw an increase in the
number of service sites. OPA attempted to recruit new grantees to
provide Title X services through a competitive funding opportunity, but
OPA only received eight applications and was only able to provide
services in three of the states with no or limited Title X services at
the time. Some comments opposing the 2021 NPRM specifically cited Ohio
as an example of a state that would be able to increase clients served
post-COVID-19. Despite the state health department receiving additional
funds to provide Title X services following the departure of another
grantee, FPAR data from Ohio, however, do not provide any clear support
for this claim and reinforce that capacity among entities is not
necessarily equivalent. According to the FPAR data from Ohio, the state
experienced a 10 percent decline in service sites between 2018 and
2020, an 18 percent decline in clients from 2018 to 2019, and a 57
percent decline in clients from 2019 to 2020. While many states and
territories experienced a decline in clients from 2019 to 2020 due to
COVID-19, Ohio's percentage decline in clients from 2019 to 2020 ranked
18th in order of states from largest decline to smallest decline.
Seventeen states experienced a larger decline in clients from 2019 to
2020, and 41 states and territories experienced a smaller decline in
clients. The data show that even if the same amount of funding is
provided to a different set of grantees in a given area, it does not
necessarily follow that the same number of clients will be served or
same number of services will be provided, depending on the differences
in grantee service capacity. Existing Title X grantees also experienced
great difficulty recruiting new sites and new providers into their
existing Title X networks under the 2019 regulations, as evidenced by
the lack of states experiencing an increase in their number of service
sites. Overall, it is clear that the 2019 rule directly resulted in a
significant loss of grantees, subrecipients, and service sites, and
close to one million fewer clients served from 2018 to 2019.
While some states and organizations were able to provide family
planning and related preventive health services in the absence of Title
X funding, the comments made clear that they were not providing the
full scope of services provided under the Title X program, they were
not provided following the
[[Page 56152]]
same standards as in Title X, and the same schedule of discounts and
subsidies were not applied as required in the Title X program. Finally,
many of the states that provided emergency or one-time funds, or those
organizations that were able to raise funds privately, indicated
through their comments that they could only do so on a very short-term
basis, that it was not sustainable for the long term, and that it came
at a price--requiring elimination of other critical services.
Given the data presented in the preamble and the data presented
above, the Department disagrees with the claim that Title X services
would improve after COVID-19 (absent a change in the 2019 rule). The
loss in clients served, the states with no service providers, and the
states with limited service providers occurred in 2019 after enactment
of the 2019 rule and prior to COVID-19, making it unlikely that the
number of clients served or services provided would increase to pre-
2019 levels or above without a change to the 2019 rule. Comparing FPAR
data for 2018 (``typical year'') and 2019 (post 2019 rule but pre-
COVID), OPA estimates that 94% (789,960) of the total decrease
(844,083) in family planning clients between 2019 and 2020 can be
attributed to the 2019 rule. Further comparing FPAR data for 2018
(``typical year'') and 2020 (post-COVID), OPA estimates that 63% (or
1.5 million) of the total decrease (2.4 million) in family planning
users between 2018 and 2020 can be attributed to the final rule. The
grantees and subrecipients that left the program have indicated that
they will not return to the program under the 2019 rule. Coupled with
the lack of additional applicants to the Department's funding
opportunity, the Department maintains the decline in access, clients,
and services from 2018 levels will continue until a new rule is in
place.
C. Grantee and Subrecipient Compliance
Comments: Several comments expressed concern that the 2021 NPRM did
not include language from 59.1 in the 2019 rule, stating, ``the
requirements imposed by these regulations apply equally to grantees and
subrecipients.'' Several comments also expressed concern that the 2021
NPRM did not include language from 59.13 specifically requiring
grantees to provide assurance that their project does not provide
abortion and does not include abortion as a method of family planning.
One comment stated that ``[t]he removal of an explicit compliance
requirement, without at minimum an explanation that subrecipients are
assumed to have to comply with all Title X regulations, suggests that
such compliance is no longer required.''
Another comment claimed that the departure of providers from the
Title X network after the introduction of the 2019 rule confirmed that
Title X funding had been used by those providers for impermissible
purposes. Additionally, the comment claimed that the withdrawal
demonstrates an unwillingness to comply with program requirements, and
that ``healthcare providers were accepting Title X funding for years
without complying with the statutory requirements of the program.''
Response: The Department disagrees with the comments and does not
believe that it is necessary to include language within the Title X
regulations stating that the regulations apply equally to grantees and
subrecipients because this is already a requirement in the HHS grants
regulations that apply to Title X grantees. All Title X grantees are
subject to 45 CFR part 75, Uniform Administrative Requirements, Cost
Principles, and Audit Requirements for HHS Awards. In fact, Title X
Notices of Funding Opportunity (NOFOs) state that successful applicants
that accept an award agree that the award and all activities under the
award are subject to all provisions of 45 CFR part 75. Specifically, 45
CFR 75.352 sets out the requirements for pass-through entities and
clearly specifies that ``all pass-through entities must (a) ensure that
every subaward is clearly identified to the subrecipient as a subaward
and includes the following information at the time of the subaward and
if any of these data elements change, include the changes in subsequent
subaward modification. . . . Required information includes . . . (2)
All requirements imposed by the pass-through entity on the subrecipient
so that the Federal award is used in accordance with Federal statutes,
regulations and the terms and conditions of the Federal award.'' Given
that Title X grantees are required to follow 45 CFR part 75, and since
45 CFR part 75 makes clear that all requirements of the grant,
including federal statutes, regulations, and terms and conditions of
the federal award, apply to all subrecipients, the Department believes
it is clear that the Title X regulations will continue to apply equally
to all grantees and subrecipients without needing to include separate
language in the Title X regulations.
Similarly, the Department does not deem it necessary to include
language within the regulation itself requiring grantees to provide
assurance that their project does not provide abortion and does not
include abortion as a method of family planning. The Department has
explicitly stated in all NOFOs that all grantees must comply with the
Title X statute, regulations, and legislative mandates, and applicants
certify in the application materials that they ``[w]ill comply with all
applicable requirements of all other Federal laws, executive orders,
regulations, and policies governing this program.'' Additionally,
compliance with program statutes and appropriations act requirements is
included as a standard term of the grant award. Therefore, during the
application process, and by accepting funds, grantees have assured
their compliance to the statute, regulations, and legislative mandates.
The Department also disagrees with the contention that withdrawal
of organizations following the 2019 rule proves that these
organizations were non-compliant with the statutory requirements. The
primary reasons cited by most grantees for withdrawing from the Title X
program after promulgation of the 2019 rule was out of concern that the
2019 rule interfered with the patient-provider relationship and
compromised their ability to provide quality healthcare to all clients.
For certain grantees, the regulation was also in direct conflict with
laws established by their state.
Furthermore, there is no evidence to suggest that the grantees that
withdrew from the Title X program had had any difficulties complying
with the Title X statute, regulations, or legislative mandates. OPA
practices, and practiced long before the 2019 rule, robust monitoring
processes to ensure grantee compliance with the statute and
regulations, including through regular grant reports, compliance
monitoring visits, and legally required audits. As stated in the
Background section, close oversight of Title X grantees for almost two
decades under the 2000 rule uncovered no misallocation of Title X funds
by grantees. OPA oversight did identify occasional instances over the
years where grantees needed to update their written policies to clearly
reflect the Title X statutory language, but OPA never found any
instance where grantees were co-mingling funds with activities not
allowed under the statute. The Department believes that grantee
compliance with the Title X statute and regulations has not been an
issue throughout the history of the Title X program, and the compliance
monitoring methods that have historically been applied by OPA prior to
the 2019 rule have ensured that
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grantees have an understanding of the statute and how to comply with
it. The Department rejects as without merit the comments that these
grantees were accepting Title X funding for years without complying
with statutory requirements. Neither the 2019 rule itself nor any
comments to the 2021 NPRM cited evidence of widespread noncompliance.
D. Application of Conscience and Religious Freedom Statutes to Title X
Comments: The Department received thousands of comments on the
preamble language concerning the application of the conscience statutes
to Title X. As further discussed in the NPRM, Congress has passed
several laws protecting the conscience rights of providers,
particularly in the area of abortion. For instance, under 42 U.S.C.
300a-7, the Church amendments, grantees may not require individual
employees who have objections to abortion to provide such abortion
counseling, or those who have objections to sterilization procedures to
perform, assist in the performance of, or provide counseling regarding
sterilizations. Since 2005, Congress has also annually enacted an
appropriations rider, the Weldon amendment, 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.
Many commenters expressed a belief that the statutory conscience
protections prohibited the agency from promulgating any counseling or
referral requirements. Conversely, some asserted that the conscience
statutes have no bearing on what requirements Title X could impose on
grantees by regulation. Many comments asserted that these statutes had
to be incorporated into the Title X regulatory text for them to be
operative or the rule to be lawful. Some stated that the statutes
themselves violated the separation between church and state. Several
other comments cited a concern that applications from providers
objecting to abortion counseling or referral would not be favorably
evaluated. Many also suggested that the Department should simply allow
for abortion counseling and referral rather than requiring it, since
the conscience statutes protect objecting providers from those
requirements in any case.
Beyond the Church and Weldon Amendments, a few comments also stated
that requiring abortion counseling or referral automatically violated
the Religious Freedom Restoration Act (RFRA), 42 U.S.C. 2000bb through
42 U.S.C. 2000bb-4. At least one comment suggested that the counseling
and referral requirements coerced speech in violation of the First
Amendment for those providers who object.
Response: The conscience statutes have been the subject of multiple
rulemakings and numerous lawsuits in the last 13 years. Most recently,
the Department finalized a rule in 2019 providing definitions and an
enforcement mechanism for several statutes protecting medical providers
who have conscience-based objections to certain activities. Protecting
Statutory Conscience Rights in Health Care; Delegations of Authority,
84 FR 23170 (May 21, 2019). That rule was vacated by three different
courts. New York v. HHS, 414 F. Supp. 3d 475, 536 (S.D.N.Y. 2019)
(appeal in abeyance); Washington v. Azar, 426 F. Supp. 3d 704, 722
(W.D. Wash. 2019) (same); City & Cty. of San Francisco v. Azar, 411 F.
Supp. 3d 1001 (N.D. Cal. 2019) (same). While the statutes may at times
interact with the requirements of Title X, interpreting these laws is
beyond the scope of this rule and the HHS Office for Civil Rights (OCR)
has been delegated authority to receive complaints under these
provisions.
Moreover, as the DC Circuit pointed out when the Weldon Amendment
was enacted and the 2000 Title X rule was in effect, ``a valid statute
always prevails over a conflicting regulation,'' Nat'l Family Planning
& Reprod. Health Ass'n v. Gonzales, 468 F.3d 826 (D.C. Cir. 2006). This
is true whether an overriding statute is incorporated into regulatory
text or not. The applicability of other rules and laws are best
evaluated by consulting those rules and laws and then seeking guidance
from the agencies responsible for implementing them. Particularly in
areas where the administrative rules may be modified or statutory
directions may change from appropriation to appropriation, it is unwise
for OPA to formalize interpretations beyond its own statutory
authority.
Irrespective of the points made above, as recounted in the NPRM,
objecting individuals and grantees will not be required to counsel or
refer for abortions in the Title X program in accordance with
applicable federal law. OPA has long worked with grantees and providers
to ensure appropriate compliance with conscience laws as well as
continuity of care. As stated above, OCR has been delegated authority
to receive any complaints related to the conscience protections and
will continue to enforce them. As discussed in the NPRM, recognition of
provider conscience rights has been the position of the Department
since before the 2000 rule. See 65 FR at 41274 (2000 rule, stating that
under ``42 U.S.C. 300a-(d), ``grantees may not require individual
employees who have such objections to provide such counseling.'').
However, as also discussed in the 2000 final rule, the Secretary was
unaware then--and is still unaware--``of any current grantees that
object to the requirement for nondirective options counseling.'' Id.
Just as non-objecting providers should not dictate the provision of
information and referrals by those who do object, the existence of
statutory conscience protections for providers does not preclude other
willing providers from providing referrals or counseling for abortion
within the program. With this final rule, the Department is emphasizing
the importance of ensuring access to equitable, affordable, client-
centered, quality family planning services. Client-centered care is
defined as being respectful of, and responsive to, individual client
preferences, needs, and values, and ensures that the client's values
guide all clinical decisions. With an emphasis on providing services
that are client-centered, the default should be the fullest provision
of information to clients. Providers may avail themselves of existing
conscience protections and file complaints with OCR, which will be
evaluated on a case-by-case basis as is done with other complaints.
As noted in previous iterations of both sets of rules, the
conscience provisions and Title X rules have existed side by side for
decades with very little conflict, or even interaction. From 1993 to
2017, Title X received no reports of grantees or individuals objecting
to the regulatory requirement to counsel or refer for abortions when
requested. See Nat'l Family Planning & Reprod. Health Ass'n, 468 F.3d
at 830 (``[T]here are structural reasons to doubt that the issue will
ever come up. In 2000 HHS Secretary Shalala declined to create a
specific exception from the pending [Title X] regulation's mandatory
referral requirement for organizations resisting provision of abortion
counseling or referrals; she explained that she was ``unaware of any
current grantees that object to the requirement for nondirective
options counseling, so this suggestion appears to be based on more of a
hypothetical than an actual concern.''). As with any issue facing Title
X grantees and applicants, the program will work to provide guidance to
grantees and coordinate any
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conflicts with the OCR. A case-by-case approach to investigations will
best enable the Department to deal with any perceived conflicts within
fact-specific situations.
The Department declines to definitively interpret RFRA or the First
Amendment in this context for largely the same reasons. Not only do the
conscience protections more specifically allow providers to object to
referral and counseling for abortion requirements, but the Title X
rules in force for decades prior to the 2019 rule also existed side by
side with RFRA and the First Amendment with no conflict. However, in
light of the comments received, and to eliminate any confusion, the
Department has noted in this final regulation that ``[p]roviders may
separately be covered by federal statutes protecting conscience and/or
civil rights.''
E. Options Counseling
Comments: The Department received thousands of comments expressing
support for ``the reinstatement of the requirement to offer
nondirective options counseling to pregnant patients.'' Many comments
expressed support for reversing the 2019 rule's restrictions on what
referrals can be provided to clients and allowing providers to offer
patients complete information about their healthcare options and refer
patients to providers who offer services to meet those needs. One
comment stated that ``reinstating the 2000 regulations would remove
this undue governmental interference into medical care and will help
ensure patients receive medically accurate, comprehensive information
from their physicians.''
The Department also received comments in opposition to removing
restrictions on referring for abortion services and requiring
nondirective counseling. Several comments opposed removing restrictions
on what referrals can be provided to clients in general, and a few
opposed removing restrictions which state that only advanced practice
providers can provide nondirective counseling. Many comments opposing
the rule expressed a belief that the information and counseling
requirements in this provision violate section 1008 of the Title X
statute. Others believed that requiring ``that grantees refer (sic)
individuals to abortion providers conflicts with the free speech and
religious freedom of grantees.'' Still others expressed concern that
the requirement could limit the type of providers in the program due to
conscience concerns.
Response: The Department appreciates the comments in support of
this provision. The Department believes that offering pregnant clients
the opportunity to receive neutral, factual information and
nondirective counseling on all pregnancy options--and providing
referral upon request for option(s) the client wishes to receive--are
critical for the delivery of quality, client-centered care. The
Department agrees that restoring this provision will remove unnecessary
limitations governing the patient-provider relationship and will enable
healthcare providers to offer complete and medically accurate
information and counseling to their clients.
The Department's response to comments opposing this provision is
included earlier in Section II. A. Compliance with Section 1008 (42
U.S.C. 300a-6) and D. Application of Conscience Statutes to Title X.
The NPRM language for this provision would restore the regulatory text
from the 2000 regulation, which successfully governed the Title X
program for decades without opposition from major medical organizations
and was widely accepted by grantees.
F. Subrecipient Nondiscrimination
Comments: The Department received many comments on state policies
restricting subrecipient participation for reasons unrelated to the
provider's ability to provide care. The majority of these comments
favored a regulatory prohibition on such restrictions because they
often exclude the best family planning providers for no discernible
purpose. Many comments stated that ``State policies putting
restrictions on how state funds are allocated, called `tiering,' make
it difficult or impossible for privately operated reproductive health-
focused providers to receive funding. Tiering and other prohibitions
against abortion providers often exclude the specialist providers that
are the most qualified and best equipped to help Title X patients
achieve their family planning goals.'' Such restrictions, which are in
place in approximately 15 states, can make access for certain sub-
populations and geographic areas more difficult. Many comments stressed
that ``expelling well-qualified, trusted family planning providers from
publicly funded health programs like Title X has adverse effects on
patients' access to critical family planning and sexual healthcare.''
The Department also received many comments, including from multiple
state Attorneys General, condemning any regulation in this area. Many
of these objections stated that such a regulation would undermine
federalism and ``intrude on the States' self-governance for no good
reason,'' and, most prominently, violate the Congressional Review Act,
5 U.S.C. 801-808. Under that law, an agency may not promulgate a rule
that is ``substantially the same'' as one that has been disapproved by
Congress. In 2016, the Department enacted a rule barring projects from
rejecting sub-grantees for non-programmatic reasons. 81 FR 91852 (Dec.
19, 2016). Congress subsequently revoked the rule. P.L. 115-23 (4/13/
2017). Multiple comments asserted that any regulation in this area
would be unlawful unless Congress specifically authorized it.
Response: All proposed additions to the 2000 rule received an
overwhelmingly positive response, except the proposal to include a
subrecipient non-discrimination provision. After carefully considering
several factors, the agency is declining to include a subrecipient non-
discrimination provision in this rulemaking. Foremost among the
Department's considerations is the sense of urgency in the interest of
public health to complete this rulemaking. This schedule allows for a
final rule to be effective before the award of the next round of
competitive funding for the Title X program. This, in turn, will enable
applicants that previously withdrew from participation in the program
as a result of the previous regulation to apply for funding.
The Department still believes state restrictions on subrecipients
unrelated to care hamper the ability of the program to achieve its
goals. However, the overriding task of this rulemaking is to undo the
negative public health effects of the previous rule. That result is
most effectively reached by not including a subrecipient non-
discrimination provision in this rulemaking. Organizations in states
with restrictive laws may still apply directly to receive Title X
grants (see PHS Act sec. 1001(b); 59.3).
G. Other Comments
Comments: While many comments were specific to certain sections of
the proposed rule, a sizeable number were more general in nature, or
commented on portions of the preamble. Many of these general comments
were summarized in detail in the sections above, and the remainder of
the general comments are summarized here.
Of those that support the proposed rule, a large number of comments
expressed general support for removing the harmful effects of the 2019
rule on Title X services. A similarly large
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number felt that the 2019 rule negatively impacted the number of
clients served and that the proposed rule will increase the number of
clients served. Many comments supported being able to expand access to
Title X services across the nation and within states and territories.
They felt that the proposed rule will result in more Title X grantees
and service sites and will increase the diversity of grantees. Many
other comments expressed support that the proposed rule will increase
health equity and decrease health disparities by increasing the number
of marginalized and vulnerable groups served by Title X.
Many comments expressed a belief that the proposed rule will result
in improved health outcomes and that the 2019 rule had a negative
impact on public health. Others supported the emphasis in the proposed
rule on quality family planning and felt that the proposed rule will
result in improved quality of care. Many comments expressed a belief
that the proposed rule better aligns with the mission of Title X and
that it will result in cost savings.
Of those that oppose the proposed rule, many expressed general
opposition to the elimination of the 2019 rule, and a large number
expressed a belief that the proposed rule does not align with the
mission of Title X. Several comments expressed a belief that the
proposed rule will result in negative health outcomes. A small number
of comments raised concern that the proposed rule will result in a
decrease in quality of care and would cost more to implement compared
to the 2019 rule.
The Department also received several comments that were not
relevant to the 2021 rule. These included several comments expressing
opposition to the use of hormone therapy for adolescents, a few
comments requesting that the Department include specific services
within Title X that are already included in Title X (e.g., STI testing,
cervical cancer prevention and treatment), and several personal
testimonials either for or against family planning in general, but not
specific to the 2021 rule.
Response: The Department agrees with the comments in support of the
proposed rule and disagrees with the comments opposed to the proposed
rule. The Department believes that the negative public health
consequences of the 2019 rule are clear. As stated in the Background
section, the 2019 rule dramatically reduced access to essential family
planning and preventive health services for hundreds of thousands of
clients, especially for the low-income clients Title X was specifically
created to serve. The 2019 rule decreased the number of providers
willing to participate in the Title X program, further reducing access
to essential family planning services within states and communities
across the country. The 2019 rule shifted Title X away from its history
of providing client-centered, quality family planning services and
instead set limits on the patient-provider relationship and the
information that could be provided to the patient by the provider. The
2019 rule resulted in increased costs for grantee reporting that are
unnecessary for ensuring grantee compliance. The Department believes
that 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.
The Department will continue to enforce and monitor grantee
compliance with all Title X statutory requirements and legislative
mandates. The Department disagrees with comments that it is necessary
to include language repeating the legislative mandates within the
regulation itself. As noted above with respect to Section II. C.
Grantee and Subrecipient Compliance, OPA explicitly states in NOFOs
that all grantees must comply with the Title X statute, regulations,
and legislative mandates, and applicants certify in the application
materials that they will comply with federal law; compliance with
program statutes and appropriations act requirements is also included
as a standard term of the Title X grant award. Therefore, during the
application process as well as by accepting funds, grantees have
assured their compliance to the statute, regulations, and legislative
mandates. Furthermore, OPA includes the legislative mandates in its
grantee orientation and trainings and regularly monitors grantee
compliance with the legislative mandates through grantee reporting and
compliance monitoring visits.
The Department believes that the adoption of the 2021 proposed rule
(86 FR 19812, April 15, 2021), with minor modifications discussed in
this rule, will result in increased access to equitable, affordable,
client-centered, quality family planning services. This will result in
improved outcomes for all clients served by Title X. Additionally, the
2021 rule will ensure that the predominantly low-income clients who
rely on Title X services as their usual source of medical care have
access to the same quality healthcare, including full medical
information and referrals, that higher-income clients and clients with
private insurance are able to access.
Comments Regarding Proposed Revisions and Technical Corrections to the
2000 Regulation
Sec. 59.2. Definitions
In the NPRM, the Department proposed revising section 59.2 of the
2000 regulations by adding several new and modified definitions. The
NPRM included a new definition of family planning services consistent
with the definition included in QFP. The NPRM also included a new
definition of service site consistent with the previous Title X Family
Planning Guidelines that implemented the 2000 regulations, the 2014
Program Requirements for Title X Funded Family Planning Projects
(``2014 Title X Program Requirements''). Finally, the NPRM included new
definitions for adolescent-friendly health services, client-centered
care, culturally and linguistically appropriate services, health
equity, inclusivity, quality healthcare, and trauma-informed services.
All new definitions included in the NPRM were taken from federal
government agencies or major medical associations. The NPRM also
retained definitions from the 2000 regulation for the following terms:
Act, family, low-income, non-profit, Secretary, and state.
Comments: The Department received numerous comments in support of
the new or revised definitions in the NPRM. Many comments expressed
strong general support for the newly-proposed definitions, including
definitions for client-centered care, cultural and linguistic
appropriateness, family planning services, health equity, inclusivity,
and trauma-informed. Numerous comments stated that ``the proposed
rule's definitions help to illustrate key aspects of quality care'' and
that ``defining how services should be provided is an important step
toward a more equitable Title X program.'' Numerous comments expressed
specific support for the emphasis on health equity in the proposed
rule. Comments expressed that the ``added definition for health equity
underscores the goal of ensuring that all Title X patients have the
opportunity to attain their full health potential.'' Many comments also
expressed support for the definition of family planning services, and
specifically the inclusion of ``FDA-approved'' contraceptive products
and reinstatement of the term ``medically approved'' to the definition.
Several comments were supportive of not
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including women whose employers do not cover contraception for
religious reasons in the definition of low-income. One comment
expressed support for the NPRM's ``returned focus on Title X's priority
population--low-income clients--and removal of the 2019 rule's re-
definition of `low income' to use the program to pay for contraceptive
services for any people whose employers refuse to include coverage for
such services in their employer sponsored insurance due to religious or
moral objections.'' Several comments also expressed support for using
more inclusive terminology throughout the NPRM and expressed that
```client' is more reflective of the diverse population of patients
served by the Title X program.''
Several comments, while supportive of the definitions included in
the NPRM, did request specific revisions to many of the new or revised
definitions. Several comments requested that the Department explicitly
include systemic racism within the definition of health equity. Another
comment requested that the Department revise the definition of health
equity by expanding ``the umbrella term `socially determined
circumstances' to `other circumstances that are socially, economically,
demographically, or geographically determined.' '' One comment
requested that the Department revise the definition of adolescent-
friendly services to include ``developmentally appropriate services
that support the healthy cognitive, physical, sexual, and psychosocial
development of adolescents as they transition from childhood to
adulthood and account for their unique needs, including with respect to
confidentiality, legal status, and autonomy.'' Other comments asked the
Department to revise the definition of inclusivity to include non-
religious people and the intersex community. One comment requested that
the definition of trauma-informed care be revised to prevent future
discrimination of transgender people by ``clarifying that a trauma-
informed program should not result in discrimination against any
population.''
The Department also received several comments opposing the new or
revised definitions. A few comments opposed the definition of client-
centered care and felt that it raised conscience concerns. Other
comments opposed the definition of family planning services and
specifically opposed removing abstinence and preconception health from
the definition. One comment opposed the definition and said that
``medically approved'' did not include natural family planning. Another
comment questioned why the definition of family planning services did
not emphasize ``supporting unexpected pregnancies with assistance
required by families and mothers--including emotional, educational,
financial, and healthcare supports.'' Other comments expressed general
opposition to the definition of family planning services and felt that
the definition included abortion and abortion-related services.
One comment stated that the definition of health equity was vague
and undermined the priority for serving low-income clients. Another
comment stated that the focus on health equity was ``targeting minority
communities to restrict pregnancy,'' and another stated that the focus
on equity was unnecessary because of protections already included in
the Constitution. One comment opposed the definition of cultural and
linguistically appropriate services and expressed that ``the phrase
`culturally and linguistically appropriate services' may bless health
practices, based on cultural norms, that lead to negative health
outcomes.'' One comment opposed the definition of ``trauma-informed''
and said it was vague and that it was not clear what was required to be
trauma-informed.
One comment opposed the definition of inclusivity and felt that it
would drive faith-based providers out of the program. Another comment
took issue with the definition of ``inclusivity'' and stated that
``segregation or prioritization of Title X services by protected
classes such as race violates the Constitution and several civil rights
laws.'' A few comments opposed the use of the word ``client'' instead
of ``woman'' throughout the NPRM and felt that the change in language
was a disservice to women. Two comments opposed removing women who
cannot receive contraception from their employer because they have a
religious or moral objection from the definition of low-income. A few
comments opposed the definition of quality healthcare. One comment
opposed including client-centered and equitable within the definition
of quality. Still another comment stressed that improving the quality
of healthcare is a ``dynamic process'' and that ``this dynamism
requires a nimbleness often unattainable by national requirements.''
The commenter requested that the definition of quality be amended to
allow ``maximum flexibility at the state and local level to establish
standards of care.''
Response: The Department appreciates the supportive comments
regarding the new and revised definitions in the NPRM and believes that
clear definitions for terms used throughout the regulations are
important for consistent implementation. The Department acknowledges
comments requested revisions to many of the definitions; however, the
Department believes that it is important to use widely accepted and
commonly used definitions from other federal agencies and national
medical organizations as the foundation for the regulation. For this
reason, the Department will not revise the proposed definitions as
requested by several comments.
The Department disagrees that the definition of client-centered
care raises conscience concerns. The purpose of the rule and the
definitions is to refocus the program as a client-centered one, where
well-being of the patient, not the provider, is the primary goal. As
stated earlier, providers may avail themselves of existing conscience
protections and file complaints with OCR, which will be evaluated on a
case-by-case basis as is done with other complaints.
The Department also disagrees with comments objecting to the
definition of family planning services. The definition of family
planning services within the NPRM is consistent with the definition of
family planning services in QFP. Contrary to some of the comments
opposed to the definition of family planning services, the definition
does include preconception health, natural family planning, and
abstinence (as a component of natural family planning). Family planning
services include a broad range of services related to achieving
pregnancy, preventing pregnancy, and assisting clients in achieving
their desired number and spacing of children. Also, given that the
focus of Title X is on helping clients achieve pregnancy, prevent
pregnancy, and achieve their desired number and spacing of children,
the Department responds to comments requesting that Title X provide
support to clients once they become pregnant by noting that this is
beyond the scope of the Title X program. Further, as is clear from
section 1008 of the Title X statute, none of the funds appropriated for
Title X are used in programs where abortion is a method of family
planning. No court has found the decades-long practice of referral upon
request to violate that prohibition.
The Department disagrees with comments expressing concern with the
definitions of health equity, cultural and linguistic appropriateness,
inclusive, low-income, quality, and trauma-informed. The definitions
proposed in the NPRM are widely used definitions from other federal
agencies and major
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medical organizations. The Department also disagrees that the
definition of inclusive will drive faith-based organizations out of
Title X or that it will segregate services; rather, the goal is to
ensure that all people can actively participate in and benefit from
family planning services. Finally, the Department disagrees with
comments opposing the use of the word ``client'' and believes that it
is important that the words used in Title X fully reflect the diversity
of Title X clients.
In conclusion, the Department adopts the definitions from the NPRM
for this provision as final with one revision and one technical
correction. Given the revisions described later to 59.5(b)(1) and
59.5(b)(6) to include reference to ``clinical services providers'' in
the regulatory text, the Department is adding a definition for
``clinical services provider'' to the final rule in 59.2. The
definition of clinical services provider comes from OPA's FPAR and has
been widely used as a definition for Title X grantees to guide their
FPAR data collection and reporting. As taken from FPAR, a clinical
services provider is defined as ``physicians, physician assistants,
nurse practitioners, certified nurse midwives, and registered nurses
with an expanded scope of practice who are trained and permitted by
state-specific regulations to perform all aspects of the user (male and
female) physical assessments recommended for contraceptive, related
preventive health, and basic infertility care.''
One technical correction in the final rule is to the definition of
family planning services. The definition in the NPRM stated, ``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.'' Since the FDA does
not approve contraceptive ``services,'' but rather approves, clears,
and authorizes (for purposes of this rulemaking, ``FDA-approved'')
``contraceptive products,'' the definition in the final 2021 rule is
revised. The final definition will now read, ``Family planning services
include a broad range of medically approved services, which includes
FDA-approved contraceptive products 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.''
In addition to this revised definition for family planning
services, the definitions from the NPRM for Act, adolescent-friendly
health services, client-centered care, culturally and linguistically
appropriate services, family, health equity, low-income, inclusive,
non-profit, quality healthcare, Secretary, service site, state, and
trauma-informed are all adopted as final.
Sec. 59.5(a)(1). Broad Range of Acceptable and Effective Medically
Approved Family Planning Methods and Services
In the NPRM, the Department proposed revising section 59.5(a)(1) of
the 2000 regulation to require sites that do not offer the broad range
of methods on-site to provide clients with a referral to a provider who
does offer the client's method of choice. In addition, the NPRM
specified that the referral must ``not unduly limit the client's access
to their method of choice.'' The complete NPRM language for this
provision stated, ``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.'' The proposed revisions
recognized that 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 the broad range of methods and
services, offering only a single method of family planning could impact
client access.
Comments: The Department received many comments in support of
section 59.5(a)(1), especially in support of the requirement that Title
X projects provide a broad range of acceptable and effective medically
approved family planning methods. Many comments expressed support for
reinstating the term ``medically approved'' to the provision. Several
comments requested that the Department add more specificity to the
regulations to further define what is meant by ``a broad range of
methods.'' One comment requested that the Department ``expect Title X
agencies to offer `many' or `almost all of the most commonly used'
methods, and use referrals as an option of last resort.'' Another
comment requested the Department to ``require each site to have at
least one type of each provider-administered method in stock, and to
have a process in place to offer other methods of contraception by
prescription if not stocked in the clinic.''
The Department also received many comments expressing concern about
allowing an organization to participate as part of a Title X project if
it only offers a single method of family planning, as long as the
entire project offers a broad range of acceptable and effective
medically approved family planning methods and services. Several
comments expressed concern that ``allowing Title X sites to offer a
single method of contraception conflicts with Quality Family Planning
standards and HHS' stated goals regarding quality, client-centered
care, and health equity.'' Several other comments requested that ``if
HHS continues to allow specific sites to offer a single method of
contraception, HHS must clarify that the method be medically approved
and effective.''
The Department received further comments regarding the language in
the NPRM requiring sites that do not offer the broad range of methods
and services to ``provide a referral, and the referral must not unduly
limit the client's access to their method of choice.'' Many comments
expressed support for requiring that sites refer clients if the site
does not offer the client's method of choice. Some comments expressed
concern that it was unclear what was meant by ``not unduly limit the
client's access'' and how the requirement would be enforced across
diverse communities. Some comments expressed concern that rural
communities with more limited access to refer clients to other
organizations nearby would be penalized if the referral was considered
to unduly limit the client's access. Some comments asserted that
requiring referrals for a client's method of choice would result in
faith-based and natural family planning providers leaving the Title X
network. Several other comments expressed concern that the referral
requirement was ``vague and
[[Page 56158]]
does not go far enough.'' One comment asked the Department to ``clearly
outline the reasons and/or circumstances under which a Title X site may
be excused from offering a broad range of medically approved methods
and parameters, including a maximum `reasonable' distance a Title X
patient would have to travel to get their method of choice.'' Another
comment asked the Department to closely monitor the accessibility of
referrals made by Title X sites. Other comments asked the Department to
provide a specific number of minutes or miles from the Title X project
to the referral location and to require that referrals be only to
another Title X site to ensure the same discounted services would be
available.
Response: The Department appreciates the supportive comments for
this provision in the 2021 rule. Since acceptable and effective
medically approved family planning methods can change over time, the
Department does not believe that additional specificity regarding what
is meant by a broad range of methods and services is necessary within
the regulatory text. Instead, the Department will provide additional
guidance and technical assistance to assist grantees in complying with
the regulation and ensuring access to a broad range of acceptable and
effective methods and services across their service sites.
The Department acknowledges the comments expressing concern with
allowing an organization to participate in a Title X project if it only
offers a single method of family planning as long as the overall
project offers the broad range of methods and services. For much of the
Title X program's history, including in the 2000 regulations, the
regulation has included this provision. The Department believes that
retaining this provision in the 2021 rule is important to ensure
flexibility in addressing community needs and recognizes that not all
Title X service sites may be able to provide access to all methods and
services. The Department will monitor and provide technical assistance
to ensure that each grantee provides access to the broad range of
acceptable and effective medically approved family planning methods and
services to their clients.
The Department disagrees that the referral requirement will result
in faith-based and natural family planning providers leaving the Title
X network. This is in part based on our longstanding experience with
the program which for decades has included faith-based and natural
family planning providers. The requirement for referral is intended to
support continuity of care for Title X clients. There are any number of
opportunities by which this requirement could be fulfilled including
directly by the clinic site or by the grantee in instances when a
provider objects or lacks capacity to fulfill this requirement. An
array of providers, including those that only offer a single method on-
site, have successfully participated in the Title X program for
decades. The Department will monitor and provide technical assistance
to ensure that supporting client access to requested methods and
services does not violate federal conscience laws. As part of the
statutory mandate, Title X projects must provide natural family
planning services, and the program will work with projects to ensure
they provide all statutorily required services. Again, the Department
is emphasizing in this final rule the importance of ensuring access to
client-centered care. Client-centered care is defined as being
respectful of, and responsive to, individual client preferences, needs,
and values, and ensuring that client values guide all clinical
decisions. With an emphasis on providing services that are client-
centered, the default should be the fullest provision of information
and services to clients.
The Department understands, based on the comments received, that it
is challenging to include within the regulation a requirement that
sites must provide a referral that does ``not unduly limit the client's
access.'' The Department fully recognizes that the referrals available
to each Title X site will differ depending on what other referral
resources are available within or near the community. Some communities
may have access to a wide range of providers to refer clients to within
the same community, while other sites may need to refer clients to
organizations located farther away. Given the challenges in having one
standard definition for what is considered undue burden across all
Title X sites, the Department has decided to revise section 59.5(a)(1)
to remove the requirement that ``the referral must not unduly limit the
client's access to their method of choice.''
In addition to the revision to remove this requirement, the final
rule will also include one technical correction for this provision. The
Department recognizes that if a Title X site does not have the client's
method of choice available on-site, the provider may be able to provide
the client with a prescription for their method of choice, rather than
having to provide a referral to another provider. To better account for
this, the final provision will now require sites that are unable to
provide clients with access to a broad range of acceptable and
effective medically approved family planning methods and services to
provide a prescription to the client for their method of choice or
referrals, as requested. As a point-of-entry to care, Title X sites
often have robust referral networks with other safety-net agencies that
are attuned to the needs of the client populations that they serve.
While a prescription or referral does not guarantee a client the same
schedule of discounts as at a Title X site, experience suggests that
the family planning safety net recognizes and takes steps to limit
accessibility burdens, including financial constraints, for the clients
they serve. In addition, the Department will provide additional
guidance and technical assistance to grantees to help them promote
accessibility and limit patient burden.
With the revisions noted above, the revised language for the 2021
rule for 59.5(a)(1) is, ``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 prescription
to the client for their method of choice or referrals, as requested.''
This revised language is adopted as final.
Sec. 59.5(a)(3). Services are Client-Centered, Culturally and
Linguistically Appropriate, Inclusive, and Trauma-Informed; Protect the
Dignity of the Individual; and Ensure Equitable and Quality Service
Delivery Consistent With Nationally Recognized Standards of Care
In the NPRM, the Department proposed revising section 59.5(a)(3) of
the 2000 regulations. In addition to providing services that protect
the dignity of the individual as required in the 2000 regulations, the
NPRM stated, ``Provide services in a manner that is client-centered,
culturally and linguistically appropriate, inclusive, and trauma-
informed; protects the
[[Page 56159]]
dignity of the individual; and ensures equitable and quality service
delivery consistent with nationally recognized standards of care.''
These revisions were aimed at increasing access and ensuring equity in
all services provided, which the Department believes is especially
important for the Title X program with a statutory priority on serving
low-income clients. In addition, the Department believes that the
revisions will result in improved services for clients.
Comments: The Department received numerous comments in support of
this revised provision. Many comments expressed full support for the
provision and urged the Department to adopt it as quickly as possible.
Others expressed specific support for the requirement that services be
client-centered: ``We support that the proposed rule names the
importance of using client-centered models of care.'' Still others
expressed specific support for the inclusion of QFP within the 2021
rule and the requirement that Title X services be consistent with
nationally recognized standards of care. One comment said, ``[T]he
Proposed Rule will again base the standards of care for the Title X
program on the QFP guidelines and require that Title X clients receive
high-quality, client-centered care that includes comprehensive,
medically accurate counseling and information, and referrals for any
other services sought.''
The Department received a few comments opposed to this provision.
One comment felt that requiring services to be client-centered,
inclusive, and trauma-informed would create additional ``burden on
applicants and providers to ensure equity within their programs.''
Another comment argued with the definition of client-centered care and
believed that it violated conscience protections. Still another
expressed concern that the requirement for equity in conjunction with
the requirement for inclusivity would violate civil rights laws and the
Constitution ``by giving certain classes of people preferential
treatment.''
Response: The Department appreciates the comments in support of
this provision and agrees that providing services in a manner required
by this provision will advance equity, increase access, improve
outcomes for Title X clients, and reinforce the longstanding
requirement that ``[s]ervices must be provided in a manner which
protects the dignity of the individual.'' The Department disagrees that
the requirements of this provision will result in additional burden for
applicants or providers, rather the requirements of this provision
simply ensure that all Title X services are of the highest quality and
align with nationally recognized standards of care. The Department also
disagrees that the requirements of this provision violate conscience
protections and provides a specific response to comments concerning
conscience earlier in Section II. D. Application of Conscience Statutes
in Title X. Finally, the requirements of this provision do not give
preferential treatment to any clients, but rather aim to ensure that
all people can actively participate in and benefit from family planning
services. In conclusion, the Department adopts the language from the
NPRM for Sec. 59.5(a)(3) as final without revisions.
Sec. 59.5(a)(4). Services Do Not Discriminate Against any Client Based
on Religion, Race, Color, National Origin, Disability, Age, Sex, Sexual
Orientation, Gender Identity, Sex Characteristics, Number of
Pregnancies, or Marital Status
The NPRM proposed the same regulatory text for this provision as
has been included in the 2000 regulations, which read ``Provide
services without regard of religion, race, color, national origin,
disability, age, sex, number of pregnancies, or marital status.''
Comments: The Department received several comments regarding this
provision and specifically expressing concerns with the phrase
``without regard of.'' Several comments expressed concern with the
specific phrase and stated that ``if Title X providers are intended, as
stated in the proposed rule, to work towards advancing health equity,
it is imperative that care is delivered in a way that intentionally
centers and considers the identity and needs of the patient.'' Several
comments requested that the Department revise the provision to instead
say ``provide services in a manner that does not discriminate against
any patient based on religion, race, color, national origin,
disability, age, sex, number of pregnancies, or marital status'' which
they felt better supports health equity.
Response: The Department agrees with the comments and believes that
revising the language as requested more clearly meets the intent of
this provision, which is to prevent discrimination in the provision of
services.
In addition, the Department is updating ``sex'' in 59.5(a)(4) to
include sexual orientation, gender identity, and sex characteristics
consistent with the section 1557 of the Affordable Care Act, case law,
Executive Order 13988 (86 FR 7023, Jan. 25, 2021), and Departmental
policy (<a href="https://www.hhs.gov/about/news/2021/05/10/hhs-announces-prohibition-sex-discrimination-includes-discrimination-basis-sexual-orientation-gender-identity.html">https://www.hhs.gov/about/news/2021/05/10/hhs-announces-prohibition-sex-discrimination-includes-discrimination-basis-sexual-orientation-gender-identity.html</a>). In Bostock v. Clayton County, 140 S.
Ct. 1731 (2020), the U.S. Supreme Court held that Title VII of the
Civil Rights Act of 1964 prohibition on employment discrimination based
on sex encompasses discrimination based on sexual orientation and
gender identity. Courts have now begun consistently interpreting
similar language--`because of sex'-- in other statutes to encompass
these protections. See Grimm v. Gloucester Cty. Sch. Bd., 972 F.3d 586,
616-617 (4th Cir 2020) (relying on Bostock to interpret Title IX as
prohibiting policy prohibiting transgender student from using bathroom
consistent with his gender identity). Moreover, as the Department of
Justice has recently emphasized ``Discrimination against intersex
individuals is similarly motivated by perceived differences between an
individual's specific sex characteristics and their sex category
(either as identified at birth or some subsequent time) . . . it is
impossible to discuss intersex status without also referring to sex.''
Title IX (<a href="http://justice.gov">justice.gov</a>). As a result of the case law and Administration
policy, the Department adds ``sexual orientation'', ``gender
identity'', and ``sex characteristics'' to 59.5(a)(4).\11\ The revised
language for the 2021 rule for 59.5(a)(4) is ``Provide services in a
manner that does not discriminate against any client based on religion,
race, color, national origin, disability, age, sex, sexual orientation,
gender identity, sex characteristics, number of pregnancies, or marital
status.'' This revised language is adopted as final.
---------------------------------------------------------------------------
\11\ This language reflects requirements on Title X projects
principally engaged in healthcare activities under 42 CFR part 59.
If grants for the production of informational materials were again
to be made under PHSA Sec. 1005, this definition might not apply.
---------------------------------------------------------------------------
Sec. 59.5(a)(8). Charges for Services With a Schedule of Discounts
In the NPRM, the Department proposed revising section 59.5(a)(8) of
the 2000 regulations by including widely accepted billing practices
from the 2014 Title X Program Requirements. The NPRM text reads,
``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.
[[Page 56160]]
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 percent FPL should not pay more (in
copayments or additional fees) than what they would otherwise pay when
the schedule of discounts is applied.''
Comments: The Department received several comments on this
provision specifically seeking closer alignment of HRSA's (Health
Resources & Service Administration) Health Center Program (authorized
by Section 330 of the PHS Act) and OPA's Title X Program to minimize
administrative burden for dually funded grantees. Specifically, one
comment suggested modifying the proposed language in Sec.
59.5(a)(8)(ii) to include additional language about sliding fee
discounts from the Health Center Program Compliance Manual that states
that sliding fee discounts are ``subject to potential legal and
contractual restrictions.'' Another comment lauded Sec. 59.5(a)(8)(ii)
for ensuring that clients with family income at or below 250 percent
FPL do not pay more than what they would otherwise pay under the
schedule of discounts; however, the comment expressed that this
``requirement violates insurance contracts and contradicts the guidance
of other funders (e.g., HRSA).'' Yet another comment expressed the need
for additional guidance specific to Title X grantees and subrecipients
operating under the Health Center Program, to assist with alignment of
billing practices.
Response: The Department fully supports minimizing administrative
burden for grantees funded under both the Title X program and HRSA's
Section 330 Health Center Program, recognizing that providers that
dually participate in the two programs have been one of the fastest
growing segments of the Title X provider network. Similar to the Health
Center Program's statutory requirement that health centers must operate
in a manner such that no patient shall be denied service due to an
individual's inability to pay, the Department also believes, and the
Title X statute requires, that an individual's ``economic status shall
not be a deterrent to participation'' in Title X program services. See
PHS Act sec. 1006(c). The Department does not believe that adding to
this rule the commenter's suggested language with respect to the Health
Center Program Compliance Manual is warranted as it is taken out of
context and does not state the statutory requirement. The Department
believes that adding language requested in the comments could hinder
Title X clients who qualify for sliding fee discounts from receiving
the discounts, which is contrary to Title X's mandate of prioritizing
services to low-income clients. Further, OPA clarifies how Title X
grantees may remain in compliance with Title X Program requirements
when integrating services with HRSA's Health Center Program grantees
and look-alikes in OPA Program Policy Notice: 2016-11: Integrating with
Primary Care Providers.''
Rather than revising the regulation and risk Title X clients not
receiving all discounts for which they qualify, OPA will continue to
work closely with HRSA to ease administrative burden for grantees
funded under both programs. The Department will provide additional
guidance and technical assistance to dually funded grantees aimed at
reducing administrative burden. In conclusion, the Department adopts
the language from the NPRM for Sec. 59.5(a)(8) as final without
revisions.
Sec. 59.5(a)(9). Reasonable Measures To Verify Client Income
In the NPRM, the Department proposed adding a new section
59.5(a)(9) to include one requirement from the 2014 Title X Program
Requirements that grantees take reasonable measures to verify client
income, and a new requirement that grantees use client self-reported
income if the income cannot be verified after reasonable attempts. The
Department believes that these proposed revisions will greatly improve
accessibility and affordability of services for low-income clients
consistently across all Title X grantees.
The NPRM text reads, ``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.''
Comments: The Department received several comments supporting the
use of self-reported income. Comments received from members of the
House of Representatives stated, ``[W]e support the Department's stance
that patients be allowed to self-report their income, removing an
unnecessary potential barrier to care.'' Other comments expressed
support that ``cost should not be a barrier'' to receiving services.
Still other reaffirmed support that allowing use of self-reported
income ``will greatly improve accessibility and affordability for low-
income and uninsured patients seeking care from Title X program
grantees.'' One comment felt that the provision did not go far enough
and asked that the language ``explicitly state that a client's self-
reported income is sufficient, and that providers do not need to verify
client income.''
The Department also received several comments on this provision
specifically seeking closer alignment between Title X and HRSA's Health
Center Program (authorized by Section 330 of the PHS Act) to minimize
administrative burden for dually funded grantees. Several comments felt
that allowing a client's self-reported income in cases where a client's
income cannot be verified despite reasonable attempts is inconsistent
with the Health Center Program guidance. Comments reported that
``health centers have broad discretion to determine the appropriate
means to assess patient income and family size. While allowing self-
declaration is typical in the health center program, some health
centers have opted to adopt a policy establishing that self-
declaration, without supporting documentation, is not an acceptable
means to verify income for every patient.''
Response: The Department appreciates the supportive comments and
agrees that the requirements in this provision will greatly improve
accessibility and affordability of services for low-income clients
consistently across all Title X grantees. The elimination of barriers
to Title X services for low-income clients is important to the Title X
program. The Department disagrees that the requirements in 59.5(a)(9)
are not compatible with HRSA's guidance. HRSA requires health centers
to operate in a manner such that no patient shall be denied service due
to an individual's inability to pay; further, HRSA Health Center
Program grantees are required to establish systems for sliding fee
scale eligibility that comply with statutory requirements under section
330 of the PHS Act and regulatory requirements under 42 CFR 51c.303(f)
and 56.303(f), which do not preclude self-declaration of income and
family size. The Department believes that the HRSA Health Center
Program requirements are fully consistent with the language in Sec.
59.5(a)(9). A strict standard of income verification at a particular
health center is a choice that does not warrant weakening a standard in
Title X that the
[[Page 56161]]
Department has created to support and reinforce the program's statutory
obligation to prioritize services to persons from low-income families.
In conclusion, the Department adopts the language from the NPRM for
Sec. 59.5(a)(9) as final without revisions.
Sec. 59.5(a)(12). State Reporting Laws
In the NPRM, the Department proposed adding 59.5(a)(12) to retain
some, but not all, language from the 2019 rule on notification or
reporting of child abuse, child molestation, sexual abuse, rape,
incest, intimate partner violence, or human trafficking. The NPRM
language stated, ``Title X projects shall comply with all State and
local laws requiring notification or reporting of child abuse, child
molestation, sexual abuse, rape, incest, intimate partner violence or
human trafficking (collectively, ``State notification laws''). 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.''
Comments: Many comments supported the elimination of section 59.17
from the 2019 rule. Comments supported eliminating ``the 2019 rule's
attempt to give HHS substantial oversight over compliance with complex
state reporting requirements.'' Many comments noted that
``professionals providing services in Title X-funded sites are aware of
their reporting obligations, already receive training on them, and make
reports in compliance with these requirements.'' Other comments
stressed that determining compliance with state reporting laws lies
with state authorities and noted that state reporting laws ``are
complex and vary widely from state to state.''
One comment written in opposition to the NPRM expressed that the
NPRM excluded ``the mandatory reporting of sex trafficking and violence
by intimate partners.'' Another comment requested that the 2019 Title X
requirement for mandatory reporting be kept fully intact. Another
comment expressed concern that the proposed rule did not include the
minor age record-keeping requirements and made an assertion that
``[t]his lack of record keeping serves to enable sex traffickers and
abusers to continue undetected in their abuse.'' The comment proposed
reinstatement of these requirements and further proposed rescinding the
funding of any grant recipient who fails to screen for and report
sexual abuse or sex trafficking.
Response: The Department agrees with comments that all Title X
recipients must follow state reporting laws and must comply with
mandatory reporting requirements regarding child abuse, child
molestation, sexual abuse, rape, or incest. The Department disagrees
with the assertion that ``. . . lack of record keeping serves to enable
sex traffickers and abusers to continue undetected in their abuse.''
States have already established specific guidelines on the details that
must be included in mandatory reports. As such, the Department believes
that it is not necessary to impose this additional reporting burden
through Title X regulations.
Since 1999, Congress has required, through the annual
appropriations bill 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.'' All
requirements in the appropriations riders are legislative mandates for
the Title X program and all Title X grantees must comply with them. The
Department will continue to enforce and monitor grantee compliance with
all Title X statutory requirements and legislative mandates, including
the mandate that ``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.''
As noted above with respect to Section II. C. Grantee and
Subrecipient Compliance, OPA explicitly states in NOFOs that all Title
X grantees must comply with the Title X statute, regulations, and
legislative mandates. In addition, Title X applicants certify in the
application materials that they will comply with federal law, and
compliance with federal law, and compliance with program statutes and
appropriations act requirements is also included as a standard term of
the Title X grant award. Therefore, during the application process as
well as by accepting funds, grantees have assured their compliance to
the statute, regulations, and legislative mandates. Furthermore, OPA
includes the legislative mandates in its grantee orientation and
trainings and regularly monitors grantee compliance with the
legislative mandates through grantee reporting and compliance
monitoring visits. OPA has consistently documented compliance with this
mandated requirement and will continue to do so. A 2005 OIG report
(OEI-02-03-00530) found that OPA has informed and periodically reminded
Title X grantees of their responsibilities regarding state child-abuse
and sexual-abuse reporting requirements.
Given the comments received and that Title X compliance with state
mandatory reporting is already required through a legislative mandate
for the Title X program, the Department does not deem it necessary to
include this provision within the final regulation itself. Furthermore,
this provision was a part of the 2019 rule that is being rescinded as a
whole because it was a set of interrelated requirements that did not
promote the public health or solve any Title X compliance concerns. In
conclusion, the Department removes language from the NPRM for Sec.
59.5(a)(12) from the 2021 final rule.
Sec. 59.5(a)(13). Subrecipient Monitoring
In the NPRM, the Department proposed adding 59.5(a)(13) to retain
some, but not all, of the language from the 2019 rule related to
subrecipient monitoring and reporting. This addition required 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 NPRM language stated, ``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.''
Comments: The Department received several comments expressing
concerns with the requirements of this provision and the high reporting
burden associated with it. One comment requested that section Sec.
59.5(a)(13) be
[[Page 56162]]
removed completely because of the additional reporting requirements it
creates. Another comment requested that the Department only require
grantees to submit the additional information required by this
provision for subrecipients during regular reports but not during the
initial application. The comment expressed a concern that for large
Title X networks, ``providing a description of all referral agencies
and individuals, and outlining collaborations with each subrecipient,
will still pose a significant burden for Title X grantees, particularly
at the time of application when applicants are often afforded 60 days
or less to apply.'' Many other comments requested that the Department
revise the language in this provision to focus only on subrecipients
and not referral agencies ``due to high burden'' of reporting given the
size of grantee networks and the high number of possible referrals made
by individual sites. One comment stressed that ``under the 2000
regulations, past grantees were required to monitor each organization
and ensure that their clinic sites had appropriate referrals, that they
were available to all clinic personnel, and that clients' medical
charts reflected appropriate referrals given and follow-up performed.
However, grantees were not required to gather every referral source and
report this information to HHS. This requirement will likely create an
administrative burden that could be accomplished through HHS monitoring
of grantees.''
Response: It is clear from the comments received that the proposed
requirements in Sec. 59.5(a)(13) are unnecessarily burdensome for
grantees and will result in Title X staff having to spend valuable time
on administrative reporting that could otherwise be spent providing
services to clients. The Department agrees that monitoring how grantees
are involving and monitoring their subrecipients in their project and
the composition of grantee referral networks can be achieved through
the Department's existing grantee compliance monitoring system.
Departmental grants regulations at 45 CFR 75.352 already document the
requirements for pass-through entities and specify the reporting
required of grantees for all pass-through entities. Furthermore, this
provision was a part of the 2019 rule that is being rescinded as a
whole because it was a set of interrelated requirements that did not
promote the public health or solve any Title X compliance concerns.
Given the challenges noted with this provision and the additional
reporting burden it would place on grantees, the Department has decided
to remove Sec. 59.5(a)(13) from the 2021 final rule.
Sec. 59.5(b)(1) Provide Medical Services Related to Family Planning
In the NPRM, the Department proposed revising section 59.5(b)(1) of
the 2000 regulations to acknowledge that consultation for medical
services related to family planning can be provided by healthcare
providers beyond the physician. Specifically, the NPRM stated,
``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.'' The proposed revision acknowledged that consultation
for healthcare services related to family planning may be by a
physician, but may also be by other healthcare providers, specifically
acknowledging participation by physician assistants and nurse
practitioners.
Comments: The Department received numerous comments supporting this
revised provision, specifically in support of the recognition that a
broad range of healthcare providers, in addition to physicians, have an
important role to play in providing medical services related to family
planning. Comments expressed agreement that ``other clinicians often
play an important role in providing family planning counseling and
other services.'' In addition, numerous comments asked the Department
to clarify that this provision includes a broader range of healthcare
providers beyond just physician assistants and nurse practitioners, as
noted in the preamble of the NPRM. One comment asked that the
Department use the definition of Clinical Services Provider from FPAR.
Many other comments stated that ``it is important to note that
`consultation by a [healthcare] provider' is not and should not be
limited only to the examples cited by HHS, as these CSPs represent only
one facet of healthcare providers in Title X settings.''
In addition to the numerous comments related to the array of
healthcare professionals that are responsible for clinical service
provision in Title X, the Department also received numerous comments
asking for the language of this provision to be revised to clearly
reflect telehealth as an acceptable service delivery modality. Several
comments expressed the importance of telehealth, especially throughout
the COVID-19 pandemic, in allowing many Title X clients to continue to
safely access essential services. Many comments expressed concern with
the Department's use of the word ``telemedicine'' in the NPRM instead
of ``telehealth'' and felt that telehealth refers ``to a broader scope
of remote healthcare services than telemedicine and includes non-
clinical services like counseling and education.'' Several comments
specifically asked the Department to revise Sec. 59.5(b)(1) to be
clear within the regulation that family planning services can be
provided ``in person or via telehealth.'' Other comments asked the
Department to specify within the regulation that telehealth services
can include ``audio-only modalities'' and expressed that ``all forms of
telehealth modalities, including audio-only must be covered to remove
any barriers of access for patients.'' One comment asked the Department
to provide guidance to Title X grantees on how to use telehealth
services to ensure access, equity, and quality.
Response: The Department appreciates the comments in support of
this provision, especially those that recognize the role of a broader
range of healthcare providers in delivering family planning services.
It was never the Department's intention to imply that the only
healthcare providers who could provide consultation under this
provision were physician assistants and nurse practitioners. Physician
assistants and nurse practitioners were included in the NPRM preamble
to provide examples, but not to be exclusionary. The Department agrees
with comments recommending use of the definition of Clinical Services
Providers from FPAR to determine who is eligible as a healthcare
provider under this provision and, as noted in the discussion related
to Section 59.2 Definitions, is adding this definition to the final
rule. The FPAR definition for Clinical Services Providers includes
``physicians, physician assistants, nurse practitioners, certified
nurse midwives, and registered nurses with an expanded scope of
practice who are trained and permitted by state-specific regulations to
perform all aspects of the user (male and female) physical assessments
recommended for contraceptive, related preventive health, and basic
infertility care.''
The Department agrees with the comments reiterating the importance
of telehealth and the role of telehealth services in expanding access
to services and advancing equity. The Department had always intended
for the final rule to apply to family planning services
[[Page 56163]]
provided in-person or via telehealth and had specifically stated in the
NPRM that the Department was ``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.'' Telehealth has played a critical role
for Title X in responding to the COVID-19 pandemic. By utilizing
telehealth modalities, Title X grantees were able to continue to
provide essential family planning services throughout the pandemic.
With the onset of COVID-19, the vast majority of Title X grantees
transitioned to some form of telehealth service delivery in order to
continue providing services while limiting contact between individuals
and protecting client safety. Telehealth was commonly used by Title X
grantees for non-urgent visits that did not require a physical exam. Of
importance, more than half of the grantees that were able to deliver
telehealth during COVID-19 reported to OPA in their progress reports
that they intended to continue offering telehealth services even after
the pandemic ends, due to the advantages for both clients and staff.
Given the comments received, the Department believes that it is
important to include language specifically in the regulatory text to
clarify that telehealth services also constitute appropriate service
delivery. The Department also agrees with the request to use the term
``telehealth'' rather than ``telemedicine'' to be clear that telehealth
services include non-clinical services like counseling and education.
While cognizant that synchronous telehealth services may be delivered
through different modes of technology and that audio-only modalities
may mitigate access barriers, particularly for those with limited
internet and/or cellular data, the Department does not agree that the
regulatory text needs to be so specific to reference the use of
``audio-only modalities,'' especially given how rapidly technology can
change. Instead, the Department will provide additional training and
technical assistance to grantees on the use of various telehealth
modalities to improve access, quality, and equity.
With the revisions noted above, the revised language of 59.5(b)(1)
for the 2021 rule is, ``Provide for medical services related to family
planning (including consultation by a clinical services provider,
examination, prescription, and continuing supervision, laboratory
examination, contraceptive supplies), in person or via telehealth, and
necessary referral to other medical facilities when medically
indicated, and provide for the effective usage of contraceptive devices
and practices.'' This revised language for Sec. 59.5(b)(1) is adopted
as final.
Sec. 59.5(b)(3) Community Education, Participation, and Engagement
In the NPRM, the Department proposed revising section 59.5(b)(3) of
the 2000 regulations to reflect the desire to engage diverse
individuals to make services accessible. Specifically, the NPRM stated,
``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.'' The revision added language to clarify the intent
to engage diverse individuals to ensure access to equitable,
affordable, client-centered, quality family planning services.
Comments: The Department received one comment expressing support
for 59.5(b)(3), especially emphasizing the importance of the
participation and engagement of diverse individuals in making family
planning services accessible, equitable, and client-centered. The
Department received one comment asking that the language of 59.5(b)(3)
be revised to ``be clear that the needs of adolescents and young
adults'' are included in community education, participation, and
engagement.
Response: The Department appreciates the comments in response to
this provision. Community education, participation, and engagement are
important for Title X projects because they help ensure that the
community is aware of the Title X program and the services available.
In addition, community participation and engagement are critical to
helping Title X providers better understand and center the needs and
experiences of the community and the clients served. Together,
community education, participation, and engagement are foundational for
ensuring access, equity, and quality through the provision of Title X
services.
In response to the one comment requesting a revision to the
provision, the Department believes that the proposed regulatory text is
broad and already includes the needs of adolescents and young adults as
currently written. The Department does not believe that additional
revisions are needed to the regulatory text in order to respond to the
comment received. In conclusion, the Department adopts the language
from the NPRM for Sec. 59.5(b)(3) as final without revisions.
59.5(b)(6) Services Under Direction of Clinical Services Provider
The NPRM proposed the same regulatory text for this provision as
has been included in the 2000 regulations, which read, ``Provide that
family planning medical services will be performed under the direction
of a physician with special training or experience in family
planning.''
Comments: The Department received numerous comments requesting
revisions to the regulatory text for this provision. Comments requested
that the regulation expand beyond physician-only directed services.
Several comments requested that the text be revised to be consistent
with the revisions to Sec. 59.5(b)(1), which recognized the importance
of a broader range of healthcare providers, in addition to physicians,
in providing family planning services. Several comments requested
revisions to expand direction of family planning services to very
specific types of healthcare providers. One comment asked that the
language clarify that nurse practitioners have the authority to direct
family planning programs. Another comment asked that the language be
revised from physician to ``licensed healthcare provider.'' Still
another asked that this section be revised to specifically authorize
physician assistants to direct family planning services.
Several other comments were specific to advanced practice
registered nurses (APRNs) and asked that the language specify that
APRNs ``be able to serve as the medical director (in states with full
practice authority).'' One commenter pointed out that ``while state
licensure rules vary, many states have granted full practice authority
to APRNs, enabling independent practice.'' Another comment requested
that the Department consider whether registered nurses could direct
family planning services ``especially in areas of provider shortage.''
A final comment asked for the text to be amended to allow services
provided ``under the direction of an advanced practice clinician, if
the services offered are within their scope of practice and if
allowable under state law.''
Response: Given the comments received, the Department agrees that
having consistency between 59.5(b)(1) and 59.5(b)(6) is important to
more clearly reflect the role of a broader range of healthcare
providers in providing
[[Page 56164]]
Title X services. The Department also agrees with comments that other
healthcare providers, including physician assistants and APRNs in many
states, have authority to direct family planning programs and should be
included within the regulation.
As stated earlier, the Department received comments in response to
59.5(b)(1) asking for more clarity on the term ``healthcare providers''
included in the NPRM, with many comments recommending use of the term
``clinical services provider'' as defined by OPA in FPAR. As a result,
the Department has revised the final language for 59.5(b)(1) to use the
term ``clinical services provider'' instead of ``healthcare provider''
and has revised 59.2 to include the FPAR definition of ``clinical
services provider'' in the regulatory text. The FPAR definition for
clinical services provider includes ``physicians, physician assistants,
nurse practitioners, certified nurse midwives, and registered nurses
with an expanded scope of practice who are trained and permitted by
state-specific regulations to perform all aspects of the user (male and
female) physical assessments recommended for contraceptive, related
preventive health, and basic infertility care.''
To ensure consistency between 59.5(b)(1) and 59.5(b)(6) as
requested in the public comments, the Department has revised the
language for the 2021 rule for 59.5(b)(6) to, ``Provide that family
planning medical services will be performed under the direction of a
clinical services provider, with services offered within their scope of
practice and allowable under state law, and with special training or
experience in family planning.'' This revised language for Sec.
59.5(b)(6) is adopted as final.
59.5(b)(8) Coordination and Use of Referrals and Linkages
In the NPRM, the Department proposed revising section 59.5(b)(8) of
the 2000 regulations to add language to include primary healthcare
providers in the list of referrals and to state that referrals are to
be to providers in close proximity to the Title X site when feasible.
The NPRM stated, ``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.''
Comments: The Department received several comments expressing
support for revising the provision to include primary healthcare
providers in the list of referrals and to require that referrals be to
nearby providers, when feasible. One comment expressed support and said
that ``referring Title X patients to local primary care physicians
would facilitate access to continuous, comprehensive healthcare.''
Several other comments expressed support and stressed the existing
collaborative relationships between many HRSA-funded health centers and
Title X sites. Comments expressed that ``referral relationships allow
the health center and the Title X site to become more familiar with one
another's operations and service lines, often serving as a useful
precursor to a more integral relationship in the future.''
Response: The Department appreciates the many supportive comments
in response to this revised provision. The Department agrees that it is
important for Title X clinics to provide referrals and linkages to a
wide range of healthcare services to help facilitate access for Title X
clients to needed healthcare services beyond family planning. Given
that the Department received no comments expressing concern with or
opposition to the proposed modification, the Department adopts the
language from the NPRM for Sec. 59.5(b)(8) as final without revisions.
Sec. 59.6 Suitability of Informational and Educational Material
In the NPRM, the Department proposed revising the 2000 regulations
by combining requirements specific to the Information and Education
Advisory Committee (``Advisory Committee'') that were in sections
59.5(a)(11) and 59.6 and consolidating all of the Advisory Committee
information in one place, under section 59.6. The NPRM proposed several
revisions to 59.6 to clarify that the regulation applies to both print
and electronic materials (in both the title of the section and
regulatory text), 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.
Specifically, the NPRM states:
``(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 as 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.''
Comments: The Department received one comment in support of the
proposed revisions that expressed that ``this will ensure that
information and materials provided to clients are appropriate and
suitable for the specific communities to be served.'' Another
[[Page 56165]]
comment shared specific support for the requirement that grantees
provide ``culturally and linguistically appropriate'' materials. One
comment opposed to this provision expressed that the language in 59.6
``remains overly narrow and prescriptive'' and recommended that the
language be revised to require ``a Community Advisory Board charged
with a broad array of responsibilities to ensure the appropriateness of
Title X services for intended communities.'' Another comment opposed
``underrepresented communities'' in composition of the advisory council
and claimed that ``to the extent it results in segregation or
prioritization of Title X services or committee membership by protected
classes such as race, it violates the Constitution and several civil
rights laws.'' This same comment also opposed having the advisory
committee review materials to certify that they are trauma-informed and
inclusive.
Response: The Department appreciates the supportive comment in
response to this provision. The role of the Advisory Committee is
critically important to ensure that the information and educational
materials provided to Title X clients are factually correct, medically
accurate, culturally and linguistically appropriate, inclusive, and
trauma-informed. Engaging the community and population served in the
Advisory Committee itself is a key strategy to inform the grantee about
the needs and experiences of the community and population served, and
to make sure that the information and education materials are
appropriate for the community and population served.
The Department disagrees with the comment that the language in 59.6
is too narrow and prescriptive. The Department believes that the
requirements set forth in 59.6 are critical for ensuring that
informational and educational materials provided to Title X clients are
factually correct, medically accurate, culturally and linguistically
appropriate, inclusive, and trauma-informed. In addition, the Title X
statute prescribes requirements related to the informational and
educational materials developed or made available under the project,
including that they ``will be suitable for the purposes of [Title X]
and for the population or community to which they are to be made
available, taking into account educational and cultural background of
the individuals to whom such materials are addressed and the standards
of such population or community with respect to such materials'' (PHS
Act sec. 1006(d)(1)), and also prescribes requirements related to the
Advisory Committee, including that the ``committee shall include
individuals broadly representative of the population or community to
which the materials are to be made available'' (PHS Act sec.
1006(d)(2)).
The Department also disagrees with the comment that the regulation
is segregating or prioritizing services or committee members. The text
of the provision calls for the Committee membership to include
``individuals broadly representative of the population or community for
which the materials are intended. . . . Including but not limited to
individuals who belong to underserved communities.'' Since all
communities served are different, the aim of this provision is to
ensure the committee is representative of the community and population
served, as required by the statute. The Department disagrees with the
opposition to having the Advisory Committee review materials to ensure
they are inclusive and trauma-informed. Providing information and
educational materials that are inclusive and trauma-informed are a
critical component of providing quality, client-centered care.
The Department does not believe that revisions are needed to the
regulatory text included in the NPRM. As a result, the Department
adopts the language from the NPRM for Sec. 59.6 as final with a
technical correction to include ``sex characteristics''.
Sec. 59.7 Grant Review Criteria
In the NPRM, the Department proposed revising section 59.7 of the
2000 regulations to add one additional review criterion that the
Department may consider in deciding which family planning projects to
fund and in what amount, which is ``the ability of the applicant to
advance health equity.'' Adding this new criterion to the 2000
regulations brings the total number of grant review criteria specified
in the regulation from seven to eight. Advancing health equity is
critical to the mission of the Title X program. The addition of this
grant review criterion will help ensure that grant funds are awarded to
those applicants who are best able to help the Department in achieving
the goal of advancing health equity through the Title X program.
Comments: The Department received several comments in response to
this revised provision asking for additional details in future funding
opportunities about what the new criterion means and how it will be
measured. One comment provided specific examples of how the Department
could operationalize the new grant review criterion. Another comment
asked the Department to ``develop additional guidance and tools that
Title X sites and other healthcare organizations can readily
implement'' to meaningfully advance health equity. Still another
comment expressed concern that the NPRM did not include an explanation
``for how a Title X project can, in fact, ensure equity in general and
specifically in a way that does not lead to actual discrimination based
on a protected basis.''
Response: The Department appreciates the comments and
recommendations received. The grant review criteria from the 2000
regulation include several criteria aimed at assessing the need,
capacity, and ability of the applicant organization, including the
relative need of the applicant, the capacity of the applicant to make
rapid and effective use of the federal assistance, the adequacy of the
applicant's facilities and staff, 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 the degree to
which the project plan adequately provides for the requirements set
forth in these regulations. In addition, the grant review criteria from
the 2000 regulation include two criteria aimed at assessing need in the
communities served, including the number of clients, and, in
particular, the number of low-income clients to be served; and the
extent to which family planning services are needed locally.
The Department believes that adding the new grant review criterion
to assess the ability of the applicant to advance health equity is
important to enable OPA to more fully assess the extent to which the
applicant's project will promote health equity through the Title X
services provided. Under 59.2, health equity is defined as ``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.''
Adding a focus on advancing health equity will not lead to
discrimination or preferential treatment as expressed by some comments
opposed to the NPRM. Rather, including a focus on advancing health
equity aims to ensure that all people can actively participate in and
benefit from family planning services. By advancing equity across the
federal government, we can create opportunities for the improvement of
communities that have been historically underserved, which benefits
everyone. The federal government's goal in advancing equity is to
provide everyone
[[Page 56166]]
with the opportunity to reach their full potential.
To measure the ability of an applicant to advance health equity,
OPA could assess how the location of planned Title X service sites
compares to the need for family planning services within the
communities served. OPA also could assess how the applicant plans to
provide services in a manner that is culturally and linguistically
appropriate. OPA could assess how the project plans to monitor outcomes
by clients' income, race, ethnicity, geographic location, etc., as well
as how the project plans to address differences in outcomes through the
Title X services provided. OPA could also ask applicants to describe
the uptake of services by client demographics to identify existing
disparities and to describe how they would work to reduce existing
disparities in service provision. In addition, some agencies within the
Department have incorporated disparity impact statements as a part of
the post-grant award process. Disparity impact statements are just one
example of a tool that OPA may consider in order to measure
demographic, cultural, and linguistic data that identify the
population(s) in which health disparities exist and the quality
improvement plan designed to address the noted disparities. These are
just examples of how this new grant review criterion could be
operationalized within future NOFOs.
The Department will provide details on how all grant review
criteria will be measured in future NOFOs, including the new grant
review criterion on advancing health equity. The Department also plans
to develop training and technical assistance products to assist family
planning providers in advancing health equity.
In conclusion, the Department adopts the language from the NPRM for
Sec. 59.7 as final with one technical correction to replace ``his
estimate'' with ``an estimate'' to reflect inclusive language.
Sec. 59.10. Confidentiality
In the NPRM, the Department proposed revising the provision of the
2000 regulations related to confidentiality, which was section 59.11 in
the 2000 regulations, but is now section 59.10, to add a widely
accepted practice in the Title X community, indicating that reasonable
efforts must be made to collect charges without jeopardizing client
confidentiality. In addition, the Department proposed 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 was
added to ensure that the client understands the implications for using
their insurance and the options available for them to maintain
confidentiality.
Specifically, the NPRM stated, ``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.''
Comments: The Department received numerous comments in support of
this provision and the proposed revisions. Many comments expressed
support for restoring ``the confidentiality protections that have been
a hallmark of the Title X program.'' Several comments expressed support
for allowing ``providers to return to the high standard of
confidentiality that all patients, including adolescents, deserve when
accessing healthcare services, especially ones as potentially sensitive
as family planning and sexual health.'' Several comments also
specifically supported the new language on potential disclosure to
policyholders.
The Department also received numerous comments requesting further
revisions to the regulatory text for 59.10. Numerous comments urged the
Department to add language to the regulatory text to clarify that
``Title X projects may not require consent of parents or guardians for
the provision of services to minors, nor can any Title X project staff
notify a parent or guardian before or after a minor has requested and/
or received Title X family planning services.''
Comments underscored that this language has been longstanding
guidance from OPA for the Title X program and is included in OPA
Program Policy Notice 2014-01: Confidential Services to Adolescents.
One comment stated, ``We encourage you to take all possible steps when
finalizing the rule to ensure that adolescents are treated with the
same client-centered approach as all other patients at Title X-funded
health centers.'' In addition, many comments generally opposed the
removal of language from the regulation that encouraged family
participation in the decision of a minor patient to seek family
planning services and requested that the language be added back into
the final regulation.
Several other comments expressed concern with a new rule from the
HHS Office of the National Coordinator for Health Information
Technology (ONC) about Electronic Health Records and information
blocking. Several comments requested that the Department confirm in the
final rule that withholding of sensitive information in compliance with
59.10 would ``fall within the ONC rule's privacy exception and would
not constitute information blocking.''
Response: The Department appreciates the comments in support of the
revised provision in the NPRM. The Department agrees with comments to
add specific language to the final rule regarding adolescent
confidentiality to reflect Title X legal requirements. Since 1981, the
Title X statute has required that, ``to the extent practical,
[grantees] shall encourage family participation'' in Title X projects.
42 U.S.C. 300(a). However, such involvement is not mandatory and
grantees are required to protect clients' confidentiality. Specifically
with respect to adolescents, courts have for decades recognized minors'
rights to receive confidential services under the Title X program. See,
e.g., Planned Parenthood Federation of America, Inc. v. Heckler, 712
F.2d 650 (D.C. Cir., 1983) (Title X expressly protects minors' rights
to seek services confidentially). See also OPA Program Policy Notice
2014-01: Confidential Services to Adolescents.
The Department does not agree that specific language needs to be
added to the final rule to clarify the applicability of the ONC rule to
Title X. Instead, as described below related to section 59.12, OPA
suggests that grantees seek guidance from ONC with respect to the
applicability of the information-blocking provision, as ONC administers
this rule and, thus, would be in the best position to interpret it.
With this revision, the final language in the 2021 rule for 59.10 is,
``(a) All information as to personal facts and circumstances obtained
by the project staff about
[[Page 56167]]
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.
(b) To the extent practical, Title X projects shall encourage
family participation.\12\ However, Title X projects may not require
consent of parents or guardians for the provision of services to
minors, nor can any Title X project staff notify a parent or guardian
before or after a minor has requested and/or received Title X family
planning services.
---------------------------------------------------------------------------
\12\ 42 U.S.C. 300(a) states: ``To the extent practical,
entities which receive grants or contracts under this subsection
shall encourage family participation in projects assisted under this
subsection.''
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This revised language for Sec. 59.10 is adopted as final.
Sec. 59.12 Other Applicable Regulations
In the NPRM, the Department included the same regulatory text as
had been included in section 59.10 of the 2000 regulations, which is a
list of additional HHS regulations that apply to the Title X family
planning services program. The NPRM proposed a technical correction to
update the list of applicable regulations by adding 45 CFR part 87.
Comments: Many comments that generally support the rule disagree
with the proposed technical correction to section 59.12, which includes
a reference to 45 CFR part 87 (``Equal Treatment for Faith-based
Organizations'') in the list of regulations that apply to the Title X
program. Such comments argued that this rule does not apply to Title X
because the previous administration explicitly declined to apply this
rule to Title X in the faith-based organizations rule issued on
December 17, 2020 (see 85 FR 82037, 82117). Additionally, these
comments argued that 45 CFR part 87 does not apply to the Title X
program because it is a health services program, and 45 CFR part 87
only applies to social services programs; thus, the reference to this
regulation should be removed from section 59.12 of the final rule.
Other comments argued that, if the Department is planning to make
technical corrections to update the list of regulations that apply to
the Title X program, it should take the opportunity to clarify the
applicability of 45 CFR part 92 (``Nondiscrimination on the Basis of
Race, Color, National Origin, Sex, Age, or Disability in Health
Programs or Activities Receiving Federal Financial Assistance and
Programs or Activities Administered by the Department of Health and
Human Services Under Title I of the Patient Protection and Affordable
Care Act or by Entities Established Under Such Title'') as well as the
statute under which it was authorized, section 1557 of the Affordable
Care Act. These comments stipulated that if the Department makes
changes to this regulation in the future, section 59.12 should be
updated at that time to include 45 CFR part 92 on this list of
applicable regulations.
Comments opposing the rule agreed with the inclusion of 45 CFR part
87 in section 59.12, but questioned why the Department did not include
an explanation for deleting references to the now-superseded 45 CFR
part 92 (``Uniform administrative requirements for grants and
cooperative agreements to state and local governments''). These
comments also argued that the Department should include a reference to
45 CFR 88 (``Protecting Statutory Conscience Rights in Health Care;
Delegations of Authority'') on the list of applicable regulations, as
it will apply to the Title X program once related litigation is
resolved.
Response: The Department appreciates the comments addressing the
proposed technical corrections to 45 CFR 59.12, but has decided to
eliminate that section from the final rule in its entirety. Since the
regulations that apply to the Title X program will apply of their own
accord, whether or not they are cross-referenced in 42 CFR part 59,
subpart A, the Department has concluded that the list of applicable
regulations in 59.12 serves no useful purpose and, in contrast, may be
misleading. The Department is concerned that since regulations are
amended frequently, any current listing of applicable regulations could
soon become outdated. Additionally, while all of the longstanding
Departmental regulations, such as those prohibiting discrimination,
still apply, the Department is concerned that the 59.12 list may
provide a false impression that only the regulations included in this
section apply to the Title X program. The Department believes that
Title X grantees can more accurately assess which regulations apply to
the Title X program by reviewing the regulations at issue and, in some
instances, seeking guidance from the agencies which administer them.
For example, several comments, in the context of addressing the
confidentiality provisions, questioned the applicability of the
information-blocking provisions in the ``21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT
Certification Program'' rule (85 FR 25642, May 1, 2020). As that rule
is administered by the HHS Office of the National Coordinator for
Health Information Technology (ONC), ONC would be in the best position
to interpret that rule.
Most importantly, OPA provides information to Title X grantees
regarding which regulations apply to their Title X programs and is
committed to providing ongoing guidance and assistance as questions
arise. OPA includes information about applicable regulations in grant
documents, such as NOFOs and Notices of Award, and in technical
assistance webinars. Given that grantees can receive accurate and up-
to-date information from OPA about which regulations apply to their
Title X programs, the Department has decided to delete section 59.12
from the final rule.
III. Regulatory Impact Analysis
A. Introduction
The Department has examined the impact of the final 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 the Department to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Department believes that this final rule is not an
economically significant regulatory action as defined by Executive
Order 12866 because it will not result in annual effects in excess of
$100 million.
The Regulatory Flexibility Act requires the Department to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The final rule will lessen
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administrative burdens for grantees of all sizes. Therefore, the
Secretary certifies that the final rule will 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 the Department 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 final rule will 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 final 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 final 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 final rule, many states
and local health departments will support the policies contained in
this final rule, and that it will increase participation by states
(many of which withdrew as a result of the 2019 rule).
B. Summary of Costs, Benefits and Transfers
This final rule will revise the regulations that govern the Title X
family planning services program by revoking the 2019 rule and
readopting the 2000 regulations with several modifications. This
approach will 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 final rule will increase the number of
grantees receiving Title X funds. In turn, the additional service sites
supported by funding will result in additional clients served under the
program. These clients receive access to contraception, and public
health screening including clinical breast exams, Papanicolau (Pap)
testing, and testing for STIs. These services result in improved family
planning and birth spacing, earlier detection of breast and cervical
cancer, and earlier detection of sexually transmitted infections
including chlamydia, gonorrhea, syphilis, and human immunodeficiency
virus (HIV), all of which correlate to net savings for the government.
This screening and testing can result in significant cost savings from
earlier treatment and other interventions. This final rule will also
increase the diversity of grantees receiving funds, including
geographic diversity to states that do not currently have a Title X
grantee.
The final rule will 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 rule.
C. Comments on the Preliminary Economic Analysis and Our Responses
On April 15, 2021, the Department issued a proposed rule to revise
regulations relating to the Title X program. The Department prepared a
preliminary regulatory impact analysis (PRIA) for the proposed rule.
Many comments were outside the scope of this rule. The paragraphs below
describe and respond to the comments received on the PRIA.
Summary of comments addressing the PRIA that were generally opposed
to the rulemaking:
Several of the comments suggested that the Department used flawed
data in its forecasts or failed to account for COVID-19 in the PRIA.
Several of the comments suggested that the Department does not have
data to assess the effect of the 2019 rule, arguing that COVID-19 is a
complicating factor. Several comments noted that clients served under
the Title X program declined between 2009 and 2018, suggesting long-
term trends can account for some of the reduction in clients served
under the 2019 rule. Other comments noted that long-term demographics
trends are responsible for the decline in services, such as rise in
median household income, rise in individuals with private insurance,
and more diverse options available in the healthcare market.
Several of the comments suggested that grantees withdrawing from
the program may not have resulted in a decline in services, and that
some services were continued with state and private funds. Several
comments pointed out that some states saw an increase in clients after
the 2019 rule. One comment argued that, when one of two Ohio grantees
left the program, the remaining grantee prevented a gap in coverage.
Responses to comments addressing the PRIA that were generally
opposed to the rulemaking:
The primary estimate of the baseline Title X service grantees,
subrecipients, service sites, and clients served are derived from
calendar year 2019 figures, which predate COVID-19. The PRIA's estimate
of the likely effect of the proposed rule is to gradually return to the
level of grantees, subrecipients, service sites, and clients that the
program supported in calendar years 2016 to 2018, which also predates
COVID-19. COVID-19 may complicate attempts to precisely estimate the
magnitude of the effect of the 2019 rule on the Title X program, but
pre-pandemic data from calendar year 2019 preceding COVID-19 reveals a
significant drop-off in grantees, subrecipients, service sites, and
clients supported by the program, which are contrary to the predictions
in the 2019 rule.\13\ The Department acknowledges the uncertainty in
the forecast of the baseline scenario of no regulatory action by
including a sensitivity analysis in the PRIA. The upper-bound forecast
of 3,095,666 clients served annually by the Title X program under the
baseline scenario of the 2019 rule is well below the approximately 4
million clients served during calendar years 2016 to 2018.
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\13\ If adjustment to the requirements of the 2019 rule took
time for grantees and prospective new grantees (and possibly
continues to do so), then immediate post-issuance difficulties in
obligating Title X funds could ease over the years, which would in
turn lead to a trend back toward pre-2019 Title X service levels
even in the analytic baseline. However, the effects of the COVID-19
pandemic would obscure, in the available data, whether such trends
are present or absent.
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The Department disagrees with the suggestion that long-term trends
drove the reduction in clients served under the 2019 rule. Between
calendar years
[[Page 56169]]
2009 and 2014, the number of clients reported served by the Title X
program declined from 5.2 million to 4.1 million, with an average
annual decline in clients served by about 211 thousand per year.
Between calendar years 2014 and 2018, the number of clients served fell
more gradually, with an average annual decline in clients served of
about 48 thousand per year. In calendar year 2019, the number of
clients served fell by about 844 thousand. The Department believes it
is appropriate to attribute the bulk of the reduction in clients served
during calendar year 2019 to the 2019 rule.
The Department agrees with the comments that state and private
funding likely averted some of the public health consequences that
would have otherwise occurred in the immediate time period following
implementation of the 2019 rule. The Department acknowledged this
limitation in the PRIA and noted that one effect of the proposed rule
would be ``transfers (for example, if Title X newly funds medical
services that would, in the absence of the proposed rule, be provided
by charitable organizations or other private payers).'' The Department
noted that several states contributed emergency or one-time funds. It
is not clear whether state or private funding will be available for the
full-time horizon of the analysis, which begins in calendar year 2022.
While the PRIA reported that ``seven states (CO, DE, KY, ND, NM,
NV, TX) experienced an increase in the number of Title X clinics after
the 2019 regulatory change,'' this observation is different than the
claim about increases in clients. Colorado, Delaware, Kentucky, North
Dakota, New Mexico, and Texas all saw declines in the number of female
users served in 2019 and 2020 compared to 2018 (male users saw declines
as well). Nevada increased the number of female users from 9,236 in
2018 to 11,156 in 2019, and again to 11,190 in 2020. The specific claim
about Ohio cannot be supported with the available data. Ohio Title X
grant recipients reported 83,497 female clients served in 2018,
dropping to 68,669 in 2019, and dropping further still to 27,322 in
2020. Similarly, given the implementation of the 2019 rule occurred
midway through the calendar year, the 2019 data likely mask the full
negative impact of the 2019 rule that year.
Summary of comments addressing the PRIA that were generally
supportive of the rulemaking:
Several comments agreed with the observation in the PRIA that the
2019 rule resulted in a reduction in grantees and clients served under
the Title X program. Several comments gave examples of states or other
entities that saw a decrease in clients served. Several comments
discussed the disproportionate impact the 2019 rule had on low-income
individuals, individuals in rural communities, people of color, and
other populations. Several comments discussed the impact of the 2019
rule on the quality of family planning services outside the Title X
program, as well as the financial impact on clients receiving services
outside the Title X program. Several comments argued that other sources
of funding besides the Title X program, including state funding, would
not be reliable sources of funding in the future.
Responses to comments addressing the PRIA that were generally
supportive of the rulemaking:
The Department appreciates the specific examples provided in
comments and agrees with the assessment that the 2019 rule resulted in
a reduction in grantees and clients served at the national level, and
that these effects were more pronounced in certain regions,
communities, and demographic groups. The PRIA concluded, and this
regulatory impact analysis affirms, that this rulemaking will likely
result in an increase in clients served within the Title X program
compared to a baseline of no further regulatory action. The Department
also maintains the finding in the Further Discussion of Distributional
Effects Section in the PRIA in this analysis that the effects of this
final rule will accrue approximately in proport
[…truncated; see source link]Indexed from Federal Register on October 7, 2021.
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