[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Proposed Rules]
[Pages 61639-61646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21359]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 59
RIN 937-AA04
Compliance With Title X Requirements by Project Recipients in
Selecting Subrecipients
AGENCY: Office of Population Affairs, Office of the Secretary,
Department of Health and Human Services.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This document seeks comment on the proposed amendment of Title
X regulations specifying the requirements Title X projects must meet to
be eligible for awards. The amendment precludes project recipients from
using criteria in their selection of subrecipients that are unrelated
to the ability to deliver services to program beneficiaries in an
effective manner.
DATES: To be considered, comments should be submitted by October 7,
2016. Subject to consideration of the comments submitted, the
Department will publish final regulations.
[[Page 61640]]
ADDRESSES: You may submit comments, identified by Regulatory
Information Number (RIN) 937-AA04, by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Enter the above docket ID number in the ``Enter Keyword or ID'' field
and click on ``Search.'' On the next Web page, click on ``Submit a
Comment'' action and follow the instructions.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions] to: Susan B. Moskosky, MS, WHNP-BC, Office of Population
Affairs, Department of Health and Human Services, 200 Independence
Avenue SW., Suite 716G, Washington, DC 20201. Comments received,
including any personal information, will be posted without change to
http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Susan B. Moskosky, MS, WHNP-BC, Office
of Population Affairs (OPA), 200 Independence Avenue SW., Suite 716G,
Washington, DC 20201; telephone: 240-453-2800; facsimile: 240-453-2801;
email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. Title X Background
The Title X Family Planning Program, Public Health Service Act
(PHSA) secs. 1001 et seq. [42 U.S.C. 300], was enacted in 1970 as part
of the Public Health Service Act. Administered by the Office of
Population Affairs (OPA) within the Office of the Assistant Secretary
for Health (OASH), Title X is the only Federal program focused solely
on providing family planning and related preventive services. In 2015,
more than 4 million individuals received services through more than
3,900 Title X-funded health centers.\1\
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\1\ Fowler, C. I., Gable, J., Wang, J., & Lasater, B. (2016,
August). Family Planning Annual Report: 2015 National Summary.
Research Triangle Park, NC: RTI International.
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Title X serves women, men, and adolescents to enable individuals to
freely determine the number and spacing of children. By law, services
are provided to low-income individuals at no or reduced cost. Services
provided through Title X-funded health centers assist in preventing
unintended pregnancies and achieving pregnancies that result in
positive birth outcomes. These services include contraceptive services,
pregnancy testing and counseling, preconception health services,
screening and treatment for sexually transmitted diseases (STD) and HIV
testing and referral for treatment, services to aid with achieving
pregnancy, basic infertility services, and screening for cervical and
breast cancer. By statute, Title X funds are not available to programs
where abortion is a method of family planning (PHSA sec. 1008), and no
federal funds in Title X or any federal program may be expended for
abortions except in cases of rape, incest, or where the life of the
mother would be endangered.\2\ Additionally, Title X implementing
regulations require that all pregnancy counseling shall be neutral and
nondirective. 42 CFR 59.5(a)(5)(ii).
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\2\ Consolidated Appropriations Act, 2016, Division H, Title V,
Public Law 114-113, secs. 506-07, 129 Stat. 2242, 2649 (2015).
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The Title X statute authorizes the Secretary ``to make grants to
and enter into contracts with public or nonprofit private entities to
assist in the establishment and operation of voluntary family planning
projects which shall offer a broad range of acceptable and effective
family planning methods and services (including natural family planning
methods, infertility services, and services for adolescents).'' PHSA
sec. 1001(a). In addition, in awarding Title X grants and contracts,
the Secretary must ``take into account the number of patients to be
served, the relative need of the applicant, and its capacity to make
rapid and effective use of such assistance.'' PHSA sec. 1001(b). The
statute also mandates that local and regional entities ``shall be
assured the right to apply for direct grants and contracts.'' PHSA sec.
1001(b). The statute delegates rulemaking authority to the Secretary to
set the terms and conditions of these grants and contracts. PHSA sec.
1006. These regulations were last revised in 2000. 65 FR 41270 (July 3,
2000).
Title X regulations delineating the criteria used to decide which
family planning projects to fund and in what amount, include, among
other factors, the extent to which family planning services are needed
locally, the number of patients to be served (and, in particular, low-
income patients), and the adequacy of the applicant's facilities and
staff. 42 CFR 59.7. Project recipients receive funds directly from the
Federal government following a competitive process. The project
recipients may elect to provide Title X services directly or by
subawarding funds to qualified entities (subrecipients). HHS is
responsible for monitoring and evaluating the project recipient's
performance and outcomes, and each project recipient that subawards to
qualified subrecipients is responsible for monitoring the performance
and outcomes of those subrecipients. The subrecipients must meet the
same Federal requirements as the project recipients, including being a
public or private nonprofit entity, and adhering to all Title X and
other applicable federal requirements. In the event of poor performance
or noncompliance, a project recipient may take enforcement actions as
described in the uniform grants rules at 45 CFR 75.371.
B. State Restrictions on Subrecipients
In the past several years, a number of states have taken actions to
restrict participation by certain types of providers as subrecipients
in the Title X Program, unrelated to the provider's ability to provide
the services required under Title X. In at least several instances,
this has led to disruption of services or reduction of services. Since
2011, 13 states have placed restrictions on or eliminated subawards
with specific types of providers based on reasons unrelated to their
ability to provide required services in an effective manner. When the
state health department is a Title X recipient, these restrictions on
subrecipient participation can apply. In several instances, these
restrictions have interfered with the ``capacity [of the applicant] to
make rapid and effective use of [Title X federal] assistance.'' PHSA
sec. 1001(b). Moreover, states that restrict eligibility of
subrecipients have caused limitations in the geographic distribution of
services, and decreased access to services through trusted and
qualified providers.
States have restricted subrecipients from participating in the
Title X program in several ways. Some states have employed a tiered
approach to compete or distribute Title X funds, whereby entities such
as comprehensive primary care providers, state health departments, or
community health centers receive a preference in the distribution of
Title X funds. This approach effectively excludes providers focused on
reproductive health from receiving funds, even though they have been
shown to provide higher quality services, such as preconception
services, and accomplish Title X programmatic objectives more
effectively.3 4 For example, in 2011,
[[Page 61641]]
Texas reduced its contribution to family planning services, and also
re-competed subawards of Title X funds using a tiered approach. The
combination of these actions decreased the Title X provider network
from 48 to 36 providers, and the number of Title X clients served was
reduced dramatically. Although another entity became the statewide
project recipient in 2013, the number of Title X clients served
decreased from 259,606 in 2011 to 166,538 in 2015.5 6 In
other cases, states have prohibited specific types of providers from
being eligible to receive Title X subawards, which has had a direct
impact on service availability, primarily for low-income women. In some
cases, experienced providers that have historically served large
numbers of patients in major cities or geographic areas have been
eliminated from participation in the Title X program. In Kansas, for
example, following the exclusion of specific family planning providers
in 2011, the number of clients, 87 percent of whom were low income (at
or below 200 percent of the Federal Poverty Level), declined from
38,461 in 2011 to 24,047 in 2015, a decrease of more than 37 percent.
As with the declines in Texas, this is a far greater decrease than the
national average of 20 percent.7 8
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\3\ Robbins, C.L., Gavin, L., Zapata, L.B., Carter, M.W.,
Lachance, C., Mautone-Smith, N., & Moskosky, S.B. (2016).
Preconception Care in Publicly Funded U.S. Clinics That Provide
Family Planning Services. American Journal of Preventive Medicine.
doi:10.1016/j.amepre.2016.02.013
\4\ Carter, M.W., Gavin, L., Zapata, L.B., Bornstein, M.,
Mautone-Smith, N., & Moskosky, S. B. (2016). Four aspects of the
scope and quality of family planning services in US publicly funded
health centers: Results from a survey of health center
administrators. Contraception. doi:10.1016/
j.contraception.2016.04.009
\5\ Fowler, CI, Lloyd, S, Gable, J, Wang, J, and McClure, E.
(November 2012). Family Planning Annual Report: 2011 National
Summary. Research Triangle Park, NC: RTI International.
\6\ Fowler, C.I., Gable, J., Wang, J., & Lasater, B. (2016,
August). Family Planning Annual Report: 2015 National Summary.
Research Triangle Park, NC: RTI International.
\7\ Fowler, CI, Lloyd, S, Gable, J, Wang, J, and McClure, E.
(November 2012). Family Planning Annual Report: 2011 National
Summary. Research Triangle Park, NC: RTI International.
\8\ Fowler, C.I., Gable, J., Wang, J., & Lasater, B. (2016,
August). Family Planning Annual Report: 2015 National Summary.
Research Triangle Park, NC: RTI International.
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In New Hampshire, in 2011, the New Hampshire Executive Council
voted not to renew the state's contract with a specific provider that
was contracted to provide Title X family planning services for more
than half of the state. To restore services to clients in the unserved
part of the state, HHS issued an emergency replacement grant, but there
was significant disruption in the delivery of services, and for
approximately three months, no Title X services were available to
potential clients in a part of the state.
Most recently, in 2016 Florida enacted a law that would have gone
into effect on July 1, 2016, prohibiting the state from making Title X
subawards to certain family planning providers.\9\ In one county alone,
1,820 clients are served by the family planning provider that would
have been excluded, and it is not clear how the needs of those clients
would have been met.
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\9\ H.B. 1411, 2016 Leg., Reg. Sess. (Fla. 2016). The law was
preliminarily enjoined on June 30, 2016. Planned Parenthood of
Southwest and Central Florida v. Philip, et al. No. 4:16cv321-RH/
CAS, 2016 U.S. Lexis 86251 (N.D. Fla. June 30, 2016) (``the
defunding provision does not survive the unconstitutional conditions
doctrine.''). The law was permanently enjoined on August 18, 2016,
in an unpublished order.
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None of these state restrictions are related to the subrecipients'
ability to effectively deliver Title X services. The previously
mentioned exclusions are based either on non-Title X health services
offered or other activities the providers conduct with non-federal
funds, or because they are a certain type of provider. The Title X
program provides family planning services based on ``the number of
patients to be served, the extent to which family planning services are
needed locally, the relative need of the applicant, and its capacity to
make rapid and effective use of [Title X Federal] assistance.'' PHSA
sec. 1001(b). Allowing project recipients, including states and other
entities, to impose restrictions on subrecipients that are unrelated to
the ability of subrecipients to provide Title X services in an
effective manner has been shown to have an adverse effect on access to
Title X services and therefore the fundamental goals of the Title X
program.
C. Litigation
Litigation concerning these restrictions has led to inconsistency
across states in how recipients may choose subrecipients. As the
restrictions vary, so have the statutory and constitutional issues in
the cases. For example, in Planned Parenthood of Kansas & Mid-Missouri
v. Moser, 747 F.3d 814, 824-25 (10th Cir. 2014), the U.S. Court of
Appeals for the Tenth Circuit preliminarily upheld a state law that did
not explicitly exclude a particular provider, but directed all Title X
funding to be allocated to hospitals and community health centers. In
finding that Title X did not provide a private cause of action for the
plaintiffs, the Court reasoned: ``HHS has deep experience and expertise
in administering Title X, and the great breadth of the statutory
language suggests a congressional intent to leave the details to the
agency. . . . Absent private suits, HHS can maintain uniformity in
administration with centralized control. . . . Of course,
administrative actions taken by HHS will often be reviewable under the
Administrative Procedure Act, but only after the federal agency has
examined the matter and had the opportunity to explain its analysis to
a court that must show substantial deference.'' Thus, while finding
deference would be afforded any agency determination of Title X
requirements, the court did not reach the merits of the plaintiff's
Supremacy Clause claims.
At least two other U.S. Courts of Appeal have specifically held
that Title X prohibits state laws that have restrictive subrecipient
eligibility criteria. See Planned Parenthood of Houston & Se. Tex. v.
Sanchez, 403 F.3d 324, 337 (5th Cir. 2005) (``[A] state eligibility
standard that altogether excludes entities that might otherwise be
eligible for federal funds is invalid under the Supremacy Clause.'');
Planned Parenthood Fed'n of Am. v. Heckler, 712 F.2d 650, 663 (D.C.
Cir. 1983) (``Although Congress is free to permit the states to
establish eligibility requirements for recipients of Title X funds,
Congress has not delegated that power to the states. Title X does not
provide, or suggest, that states are permitted to determine eligibility
criteria for participants in Title X programs.'' (internal quotation
marks and citation omitted)); see also Planned Parenthood of Cent. N.
Carolina v. Cansler, 877 F. Supp. 2d 310, 331-32 (M.D.N.C. 2012)
(``Therefore, the Court concludes once again that the fact that
Plaintiff may, at some point in the future, be able to apply directly
for Title X funding does not mean that the state may now or in the
future impose additional eligibility criteria or exclusions with
respect to the Title X funding administered by the state.''); Planned
Parenthood of Billings, Inc. v. State of Mont., 648 F. Supp. 47, 50 (D.
Mont. 1986) (``Based on the foregoing, the Court concludes the co-
location proviso contained in the Montana General Appropriations Act of
1985 adds an impermissible condition of eligibility for federal funding
under the Public Health Service Act, in violation of the Supremacy
clause.'').
These and other appellate courts have also considered First
Amendment issues in adjudicating state restrictions, though not all
cases have involved Title X funds. Some courts have concluded certain
state restrictions do not violate the Constitution. See, e.g., Planned
Parenthood of Indiana, Inc. v. Comm'r of Indiana State Dep't of Health,
699 F. 3d 962, 988 (7th Cir. 2012); see also Planned Parenthood Ass'n
of Hidalgo Cty. Texas, Inc. v. Suehs, 692 F.3d 343, 350 (5th Cir.
2012). Other courts have found the restrictions violate the
Constitution by conditioning funding on First Amendment rights. See
Planned
[[Page 61642]]
Parenthood Association of Utah v. Herbert, No. 2:15-CV-00693-CW, 2016
U.S. App. LEXIS 12788, *36-38, (10th Cir. July 12, 2016)); Planned
Parenthood of Southwest and Central Florida v. Philip et al., No.
4:16cv321-RH/CAS, 2016 U.S. Dist. LEXIS 86251, *15-16 (N.D. Fl. June
30, 2016); Planned Parenthood of Greater Ohio v. Hodges, No 1:116cv539,
2016 U.S. Dist. Lexis 106985, *22 (S.D. Oh. August 12, 2016).
II. Proposed Rule
The Department is proposing to amend the regulations at 42 CFR 59.3
to require that project recipients that do not provide services
directly may not prohibit subrecipients from participating on bases
unrelated to their ability to provide Title X services effectively. The
proposed rule will maintain uniformity in administration, ensure
consistency of subrecipient participation across grant awards, improve
the provision of services to populations in appropriate geographic
areas, and guarantee Title X resources are allocated on the basis of
fulfilling Title X family planning goals. The deleterious effects
already caused by restrictions in several states as outlined above
justify a rule in order to fulfill the purpose of Title X. The proposed
rule helps fulfill the declared purpose of providing a broad range of
family planning methods and services to populations most in need.
Nothing in the statute supports giving discretion to project recipients
to make eligibility restrictions that may adversely affect
accessibility of Title X services.
The proposed rule will further Title X's purpose by protecting
access of intended beneficiaries to Title X service providers that
offer a broad range of acceptable and effective family planning methods
and services. Title X regulations at 42 CFR 59.7 lay out the criteria
for how the Department decides which family planning projects to fund
and in what amount, based on the Department's judgment as to which
projects best promote the purposes of the statute. Among these criteria
are: The number of patients to be served (in particular, low-income
patients), as well as the adequacy of the applicant's facilities and
staff.
Data show that specific provider types with a reproductive health
focus provide a broader range of contraceptive methods on-site, and are
more likely to have protocols that assist clients with initiating and
continuing to use methods without barriers.\10\ In addition, these
providers have been shown to serve disproportionately more clients in
need of publicly funded family planning services than do public health
departments and federally qualified health centers (FQHCs). One
reproductive-focused provider constitutes ten percent of all publicly
supported family planning centers, yet serves more than one-third of
the clients who obtain publicly supported contraceptive services. In
comparison, one-third of all publicly funded clinics are administered
by public health departments, and they serve only about one-third of
clients that receive publicly-funded family planning services. On
average, an individual FQHC serves 330 contraceptive clients per year
and a health department serves 750, as compared to specific family
planning providers that on average serve 3,000 contraceptive clients
per year.\11\ To exclude providers that serve large numbers of clients
in need of publicly funded services limits access for patients who need
these services. Furthermore, in 2011, 71 percent of family planning
organizations in Texas widely offered long-acting reversible
contraception; in 2012-2013 following enactment of legislation in Texas
that reduced funding and restricted provider participation in the
state's family planning program, only 46 percent of family planning
agencies did so.\12\
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\10\ Frost JJ et al., Variation in Service Delivery Practices
Among Clinics Providing Publicly Funded Family Planning Services in
2010, New York: Guttmacher Institute, 2012, <www.guttmacher.org/pubs/clinic-survey-2010.pdf>.
\11\ Frost JJ, Zolna MR and Frohwirth L, Contraceptive Needs and
Services, 2010, New York: Guttmacher Institute, 2013, <http://www.guttmacher.org/pubs/win/contraceptive-needs-2010.pdf>.
\12\ White, K., Hopkins, K., Aiken, A., Stevenson, A., Lopez,
C.H., Grossman, D., & Potter, J. (2013). The impact of reproductive
health legislation on family planning clinic services in Texas.
Contraception, 88(3), 445. doi:10.1016/j.contraception.2013.05.059
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In April 2014, CDC and the Office of Population Affairs released
clinical recommendations, ``Providing Quality Family Planning Services:
Recommendations of CDC and the U.S. Office of Population Affairs,''
\13\ (QFP) which identify core components of quality family planning
services. Preconception care (PCC) was identified as one of the most
important services to be provided as part of high quality family
planning. As explained in QFP, preconception care services ``promote
the health of women of reproductive age before conception, and help to
reduce pregnancy-related adverse outcomes, such as low birth weight,
premature birth, and infant mortality.'' A nationally representative
study was performed prior to release of these recommendations to assess
the prevalence of PCC services being delivered. Study results were
tabulated according to the type of publicly funded site where the
services were provided (Community Health Center, Health Department,
Planned Parenthood, Outpatient Hospitals, and other clinics). Study
results indicated that all provider types lagged behind the focused
reproductive health providers in providing these PCC services, an
indication of higher quality services.\14\
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\13\ Gavin, L., & Pazol, K. (2016). Update: Providing Quality
Family Planning Services--Recommendations from CDC and the U.S.
Office of Population Affairs, 2015. MMWR. Morbidity and Mortality
Weekly Report MMWR Morb. Mortal. Wkly. Rep., 65(9), 231-234.
doi:10.15585/mmwr.mm6509a3.
\14\ Robbins, C.L., Gavin, L., Zapata, L.B., Carter, M.W.,
Lachance, C., Mautone-Smith, N., & Moskosky, S.B. (2016).
Preconception Care in Publicly Funded U.S. Clinics That Provide
Family Planning Services. American Journal of Preventive Medicine.
doi:10.1016/j.amepre.2016.02.013.
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Another study, using nationally representative survey data,
examined four aspects of the scope and quality of family planning
service delivery before release of the QFP: The scope of family
planning services provided, contraceptive methods provided onsite,
written contraceptive counseling protocols, and youth-friendly
services. In assessing the scope of family planning services provided,
providers were asked about the provision of the following services in
the past three months: Pregnancy diagnosis and counseling,
contraceptive services, basic infertility services, STD screening, and
preconception health care. To assess contraceptive methods provided
onsite, questions were asked regarding the provision of a range of
reversible methods on site, as well as the presence of contraceptive
counseling protocols. Again, as described in the previous study,
results were tabulated according to the type of publicly funded site
where services were provided. Across all four aspects, the focused
reproductive health providers provided services that were broader in
scope and of higher quality across all four aspects of family planning
service delivery.\15\
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\15\ Carter, M.W., Gavin, L., Zapata, L.B., Bornstein, M.,
Mautone-Smith, N., & Moskosky, S.B. (2016). Four aspects of the
scope and quality of family planning services in US publicly funded
health centers: Results from a survey of health center
administrators. Contraception. doi:10.1016/
j.contraception.2016.04.009.
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Data show that restricting specific providers of Title X services
has harmful effects on access to family planning services and is linked
with increased pregnancy rates that are not in line with population-
wide trends. In addition, studies have shown that state actions to
exclude specific family
[[Page 61643]]
planning providers from publicly funded programs has contributed to a
host of barriers to care and poor health outcomes, including reduced
use of highly effective methods of contraception and corresponding
increases in rates of childbirth among populations that rely on
Federally supported care; \16\ decreased utilization rates of other
preventive services, including cancer screenings, particularly for
women with low educational attainment; \17\ and an increase in reported
barriers to reproductive health care services, particularly for young,
low-income, Spanish-speaking, and immigrant women.\18\ Specifically, in
Texas, when certain Title X providers were barred from participation in
the program, in counties where those providers provided services,
uptake of the most effective forms of contraception decreased by up to
35.5 percent, and the rate of childbirth covered by Medicaid increased
by 1.9 percentage points, while pregnancy rates decreased in the rest
of the state. Specifically, the study assessed rates of contraceptive
method provision, method continuation, and childbirth covered by
Medicaid between 2011 and 2014, corresponding to two years before and
two years after the providers' exclusion.\19\
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\16\ Frost, J.J., Frowirth, L., & Zolna, M.R. Contraceptive
Needs and Services, 2013 Update, Guttmacher Institute, July 2015.
\17\ Lu, Y. and Slusky, D.J.G., ``The Impact of Family Planning
Cuts on Preventive Care,'' Princeton Center for Health and Wellbeing
Working Paper, (May 20, 2014), available at http://ssrn.com/abstract=2442148.
\18\ Texas Policy Evaluation Project, Research Brief: Barriers
to Family Planning Access in Texas (May 2015), available at http://www.utexas.edu/cola/orgs/txpep/_files/pdf/TxPEP-ResearchBrief_Barriers-to-Family-Planning-Access-in-Texas_May2015.pdf.
\19\ Effect of Removal of Planned Parenthood from the Texas
Women's Health Program. (2016). New England Journal of Medicine N
Engl J Med, 374(13), 1298-1298. doi:10.1056/nejmx160006.
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Denying participation by family planning providers that can provide
effective services has also resulted in populations in certain
geographic areas being left without a Title X provider for an extended
period of time, such as in New Hampshire in 2011 (detailed previously).
In some cases, excluded providers do not have the administrative
capacity to directly apply for and manage a Title X grant, as was the
case in Kansas when specific family planning providers were excluded by
the state from participation in the Title X Program. The data show that
restrictions hurt the priority population for publicly funded family
planning services, and that providers that are focused specifically on
family planning service provision generally provide better access and
higher quality family planning services, which is the purpose of the
program.\20\
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\20\ Carter, M.W., Gavin, L., Zapata, L.B., Bornstein, M.,
Mautone-Smith, N., & Moskosky, S.B. (2016). Four aspects of the
scope and quality of family planning services in US publicly funded
health centers: Results from a survey of health center
administrators. Contraception. doi:10.1016/
j.contraception.2016.04.009.
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Under the proposed rule, all project recipients that do not provide
the services directly must only choose subrecipients on the basis of
their ability to effectively deliver Title X required services.\21\
Non-profit project recipients that do not provide all services directly
must also allow any qualified providers that can effectively provide
services in a given area to apply to provide those services, and they
may not continue or begin contracting (or subawarding) with providers
simply because they are affiliated in some way that is unrelated to
programmatic objectives of Title X. Project recipients that directly
provide services will not be required to start awarding to
subrecipients. For instance, some recipients provide services directly,
meaning they directly operate the service sites, the business
operations are controlled by the recipient, and the recipient directly
controls the clinics (e.g., clinic hours, staffing, etc.) and the
delivery of services (e.g., consistent clinical protocols throughout
the system). This is the case for some public recipients, such as state
health departments, as well as non-profits. For example, some state
departments of health provide all services directly--the local and
county health departments are considered part of the state, and the
staff in the health departments are state health department staff. In
comparison, some health departments make subawards to county health
departments and/or non-profit agencies within their services network
for the delivery of family planning services.
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\21\ Grant recipients would also continue to be subject to
uniform grant rule requirements, 45 CFR 75.352.
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Under the proposed rule, a tiering structure--described above--
would not be allowable unless it could be shown that the top tier
provider (e.g., community health center or other provider type) more
effectively delivered Title X services than a lower tier provider. In
addition, a preference for particular subspecialty providers would have
to be justified by showing that they more effectively deliver Title X
services. Furthermore, actions that favor `comprehensive providers'
would require justification that those providers are at least as
effective as other subrecipients applying for funds. The proposed rule
does not limit all types of providers from competing for subrecipient
funds, but delimits the criteria by which a project recipient can
allocate those funds based on the objectives in Title X.
The Department seeks comments on several issues. The Department is
cognizant of administrative burdens on both itself and project
recipients that could result from the proposed changes, as discussed
further below in the Regulatory Impact Analysis, and seeks comment on
how to minimize them. Additionally, the Department seeks input on
whether other portions of the Title X rules might need to be amended to
conform to this rule regarding the selection of subrecipients. We
invite comments on the utility of requiring compliance reports or other
records demonstrating a project recipient's criteria for selecting
providers, or whether a complaint-driven process would promote the same
goals more efficiently. Project recipients found out of compliance
would have all the same rights to appeal adverse determinations under
the proposed rule as they do any other agency decision. For example,
after voluntary compliance avenues have failed and the Department
determines to terminate the grant, grantees could appeal wrongful
termination claims through the Departmental Appeals Board process. 42
CFR 59.10.
While the Department is also aware of the scope of the proposed
rule, it does not believe it will interfere with other generally
applicable state laws. If, for example, a state law requires certain
wage rates, or addresses family leave or non-discrimination, this rule
will not interfere with that law, since all subrecipients will be
similarly situated as to that state law. Only those laws which directly
distinguish among Title X providers for reasons unrelated to their
ability to deliver services would be implicated, and then, only if the
state chooses to continue to apply for funding. The Department seeks
comment on the regulatory language and ways it may be seen as
interacting with other state law provisions.
While specifically seeking comment on the issues outlined above,
the Department invites comments on any other issues raised by the
proposed regulation.
III. Regulatory Impact Analysis
A. Introduction
HHS has examined the impact of this proposed rule under Executive
Order
[[Page 61644]]
12866 on Regulatory Planning and Review (September 30, 1993), Executive
Order 13563 on Improving Regulation and Regulatory Review (January 18,
2011), the Regulatory Flexibility Act of 1980 (Pub. L. 96-354,
September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4, March 22, 1995), and Executive Order 13132 on Federalism (August
4, 1999).
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health, and safety
effects; distributive impacts; and equity). Executive Order 13563 is
supplemental to and reaffirms the principles, structures, and
definitions governing regulatory review as established in Executive
Order 12866. HHS expects that this proposed rule will not have an
annual effect on the economy of $100 million or more in at least 1
year. Therefore, this rule will not be an economically significant
regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act (RFA) requires agencies that issue a
regulation to analyze options for regulatory relief of small businesses
if a rule has a significant impact on a substantial number of small
entities. The RFA generally defines a ``small entity'' as (1) a
proprietary firm meeting the size standards of the Small Business
Administration; (2) a nonprofit organization that is not dominant in
its field; or (3) a small government jurisdiction with a population of
less than 50,000 (States and individuals are not included in the
definition of ``small entity''). For similar rules, HHS considers a
rule to have a significant economic impact on a substantial number of
small entities if at least 5 percent of small entities experience an
impact of more than 3 percent of revenue. HHS anticipates that the
proposed rule will not have a significant economic impact on a
substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $146 million, using the most current (2015) implicit
price deflator for the gross domestic product. This proposed rule would
not trigger the Unfunded Mandate Reform Act because it will not result
in any expenditure by states or other government entities.
B. Summary of the Proposed Rule
Since 2011, 13 states have taken actions to restrict participation
by certain types of providers as subrecipients in the Title X program
based on factors unrelated to the providers' ability to provide the
services required under Title X effectively. In at least several
instances, this has led to disruption of services or reduction of
services where a public entity, such as a state health department,
holds a Title X grant and makes subawards to subrecipients for the
provision of services. In response to these actions, this proposed rule
requires that any Title X recipient subawarding funds for the provision
of Title X services not prohibit a potential subrecipient from
participating for reasons unrelated to its ability to provide services
effectively.
C. Need for the Proposed Rule
Certain states have policies in place which limit access to high
quality family planning services by restricting specific types of
providers from participating in the Title X program. These policies,
and varying court decisions on their legality, has led to uncertainty
among grantees, inconsistency in program administration, and diminished
access to services for Title X target populations. These restrictive
state policies exclude certain providers for reasons unrelated to their
ability to provide Title X services effectively. As a result of these
state policies, providers previously determined by Title X grantees to
be effective providers of family planning services have been excluded
from participation in the Title X program. In turn, the exclusion of
these high quality providers is associated with a reduction in the
quality of family planning services, the number of Title X service
sites, reduced geographic availability of Title X services, and fewer
Title X clients served.22 23 This proposed regulation seeks
to ensure that state policies regarding Title X do not direct funding
to subrecipients for reasons other than their ability to meet the
objectives of the Title X program.
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\22\ Fowler, CI, Lloyd, S, Gable, J, Wang, J, and McClure, E.
(November 2012). Family Planning Annual Report: 2011 National
Summary. Research Triangle Park, NC: RTI International.
\23\ Fowler, C.I., Gable, J., Wang, J., & Lasater, B. (2015,
August). Family Planning Annual Report: 2014 national summary.
Research Triangle Park, NC: RTI International.
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Reducing access to Title X services has many adverse effects. Title
X services have a dramatic effect on the number of unintended
pregnancies and births in the United States. For example, services
provided by Title X-funded sites helped prevent an estimated 1 million
unintended pregnancies in 2010 which would have resulted in an
estimated 501,000 unplanned births.\24\ The Title X program also helps
prevent the spread of STDs by providing screening and treatment.\25\
The program helps reduce maternal morbidity and mortality, as well as
low birth weight, premature birth, and infant
mortality.26 27 Title X as it exists today is also very cost
effective: Every grant dollar spent on family planning saves an average
of $7.09 in Medicaid-related costs.\28\
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\24\ Frost JJ, Zolna MR and Frohwirth L, Contraceptive Needs and
Services, 2010, New York: Guttmacher Institute, 2013, <http://www.guttmacher.org/pubs/win/contraceptive-needs-2010.pdf>.
\25\ Fowler, CI, Gable, J, Wang, J, and McClure, E. (November
2013). Family Planning Annual Report: 2012 National Summary.
Research Triangle Park, NC: RTI International.
\26\ Kavanaugh ML and Anderson RM, Contraception and Beyond: The
Health Benefits of Services Provided at Family Planning Centers, New
York: Guttmacher Institute, 2013 <https://www.guttmacher.org/sites/default/files/report_pdf/health-benefits.pdf>.
\27\ Preconception Health and Reproductive Life Plan. (n.d.).
Retrieved May 18, 2016, from http://www.hhs.gov/opa/title-x-family-planning/initiatives-and-resources/preconception-reproductive-life-plan/.
\28\ Frost, J.J., Sonfield, A., Zolna, M.R., & Finer, L.B.
(2014). Return on Investment: A Fuller Assessment of the Benefits
and Cost Savings of the US Publicly Funded Family Planning Program.
Milbank Quarterly, 92(4), 696-749. doi:10.1111/1468-0009.12080.
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In addition to reducing access to the Title X program, these
policies may reduce the quality of Title X services, as described
previously. Research has shown that providers with a reproductive
health focus provide services that more closely align with the
statutory and regulatory goals and purposes of the Title X Program. In
particular, these entities provide a broader range of contraceptive
methods on-site, are more likely to have written protocols that assist
clients with initiating and continuing contraceptive use without
barriers, disproportionately serve more clients in need of family
planning services, and provide higher quality services as stipulated in
national recommendations, ``Providing Quality Family Planning Services:
Recommendations of CDC and the U.S. Office of Population Affairs.''
Policies that eliminate specific reproductive health providers for
[[Page 61645]]
reasons unrelated to their ability to provide the quality family
planning services in an effective manner may shift funding from
relatively high quality family planning service providers to providers
of lower quality. This, in turn, can reduce access to high quality
family planning services for the populations that need these services
the most. This regulation takes the simplest approach to reverse the
adverse effects of these policies that exclude certain reproductive
health care providers for reasons unrelated to their ability to provide
services effectively.
D. Analysis of Benefits and Costs
1. Benefits to Potential Title X Clients and Reduced Federal
Expenditures
This proposed rule directly prohibits Title X recipients that
subaward funds for the provision of Title X services from excluding an
entity from participating for reasons unrelated to its ability to
provide services effectively. Following the implementation of policies
this regulation proposes to reverse, states shifted funding away from
family planning service providers previously determined to be most
effective. We believe that this proposed rule is likely to undo these
effects, resulting in a shift toward service providers previously
determined to be the most effective. To the extent that a state may
come into compliance with this regulation by relinquishing its Title X
grant or not applying for a Title X grant, other organizations could
compete for Title X funding to deliver services in areas where a state
entity previously subawarded funds for the delivery of Title X
services. In turn, we expect that this will reverse the associated
reduction in access to Title X services and deterioration of outcomes
for affected populations.
Research has shown that every grant dollar spent on family planning
saves an average of $7.09 in Medicaid-related expenditures.\29\ In
addition to reducing spending, these services improve health and
quality of life for affected individuals, suggesting the return on
investment to these family planning services is even higher. For
example, these services reduce the incidence of invasive cervical
cancer and sexually transmitted infections in addition to improving
birth outcomes through reductions in preterm and low birth weight
births.\30\ Data show that specific provider types with a reproductive
health focus have been shown to serve disproportionately more clients
in need of publicly funded family planning services than do public
health departments and federally qualified health centers (FQHCs).\31\
Therefore, eliminating discrimination against certain providers is
expected to result in an increased number of patients served and
services delivered by the Title X program. We expect that the return on
investment among higher quality, more efficient providers is even
higher than the average return on investment discussed above, and that
shifting funding away from these providers has reduced the return on
investment to family planning services. We estimate that the changes
proposed here will reduce unintended pregnancies, increase savings to
Medicaid, and improve the health and wellbeing of many individuals
across the country.
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\29\ Frost, J.J., Sonfield, A., Zolna, M.R., & Finer, L.B.
(2014). Return on Investment: A Fuller Assessment of the Benefits
and Cost Savings of the US Publicly Funded Family Planning Program.
Milbank Quarterly, 92(4), 696-749. doi:10.1111/1468-0009.12080.
\30\ Frost, J.J., Sonfield, A., Zolna, M.R., & Finer, L.B.
(2014). Return on Investment: A Fuller Assessment of the Benefits
and Cost Savings of the US Publicly Funded Family Planning Program.
Milbank Quarterly, 92(4), 696-749. doi:10.1111/1468-0009.12080.
\31\ Frost JJ, Zolna MR and Frohwirth L, Contraceptive Needs and
Services, 2010, New York: Guttmacher Institute, 2013, <http://www.guttmacher.org/pubs/win/contraceptive-needs-2010.pdf>.
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2. Costs to the Federal Government Associated With Disseminating
Information About the Rule and Evaluating Grant Applications for
Conformance With Policy
Following publication of a final rule that builds upon this
proposal and public comments, OPA will work to educate Title X program
recipients and applicants about the requirement to not prohibit a
potential subrecipient from participating for reasons unrelated to its
ability to provide services effectively. OPA will send a letter
summarizing the change to current recipients of Title X funds and post
the letter to its Web site. OPA will also add conforming language to
its related forthcoming funding opportunity announcements (FOAs). OPA
has existing channels for disseminating information to stakeholders.
Therefore, based on previous experience, the Department estimates that
preparing and disseminating these materials will require approximately
one to three percent of a full-time equivalent OPA employee at the GS-
12 step 5 level. Based on federal wage schedule for 2016 in the
Washington, DC area, GS-12 step 5 level corresponds to an annual salary
of $87,821. We double this salary cost to account for overhead and
benefits. As a result, we estimate a cost of approximately $1,800--
$5,300 to disseminate information following publication of the final
rule.
3. Grant Recipient Costs To Evaluate and Implement the Policy Change
We expect that, if this proposed rule is finalized, stakeholders
including grant applicants and recipients potentially affected by this
proposed policy change will process the information and decide how to
respond. This change will not affect the majority of current
recipients, and as a result the majority of current recipients will
spend very little time reviewing these changes before deciding that no
change in behavior is required. For the states that currently hold
Title X grants and have laws or policies restricting Title X
subrecipients, the final rule would implicate state law or policy.
State agencies that currently restrict subawards would need to
carefully revise their current practices in order to comply with these
changes.
We estimate that current and potential recipients will spend an
average of one to two hours processing the information and deciding
what action to take. We note that individual responses are likely to
vary, as many parties unaffected by these changes will spend a
negligible amount of time in response to these changes. According to
the U.S. Bureau of Labor Statistics,\1\ the average hourly wage for a
chief executive in state government is $54.26, which we believe is a
good proxy for the individuals who will spend time on these activities.
After adjusting upward by 100 percent to account for overhead and
benefits, we estimate that the per-hour cost of a state government
executive's time is $108.52. Thus, the average cost per current or
potential grant recipient to process this information and decide upon a
course of action is estimated to be $108.52-$217.04. OPA will
disseminate information to an estimated 89 Title X grant recipients. As
a result, we estimate that dissemination will result in a total cost of
approximately $9,700-$19,300.
4. Summary of Impacts
Public funding for family planning services is likely to shift to
providers that see a higher number of patients and provide higher
quality services. Increases in the quantity and quality of Title X
service utilization will lead to fewer unintended pregnancies, improved
health outcomes, reduced Medicaid costs, and increased quality of life
for many individuals and families. The proposed rule's impacts will
take place over a long period of time, as it will allow for the
continued flow of
[[Page 61646]]
funding to provide family planning services for those most in need, and
it will prevent future attempts to provide Title X funding to
subrecipients for reasons other than their ability to best meet the
objectives of the Title X program.
We estimate costs of $11,400-$24,600 in the first year following
publication of the final rule, and suggest that this rule is beneficial
to society in increasing access to and quality of care. We note that
the estimates provided here are uncertain.
E. Analysis of Regulatory Alternatives
We carefully considered the option of not pursuing regulatory
action. However, as discussed previously, not pursuing regulatory
action means allowing the continued provision of Title X funds to
subrecipients for reasons other than their ability to provide high
quality family planning services. This, in turn, means accepting
reductions in access to and quality of services to populations who rely
on Title X. As a result, we chose to pursue regulatory action.
F. Executive Order 13132 Federalism Review
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a final rule that imposes
substantial direct requirement costs on state and local governments,
preempts state law, or otherwise has federalism implications. The
Department particularly invites comments from states and local
governments, and will consult with them as needed in promulgating the
final rule. While we do not believe this rule will cause substantial
economic impact on the states, it will implicate some state laws if
states wish to apply for federal Title X funds. Therefore, the
following federalism impact statement is provided.
E.O. 13132 establishes the need for Federal agency deference and
restraint in taking action that would curtail the policy-making
discretion of the states or otherwise have a substantial impact on the
expenditure of state funds. The proposed rule simply sets the
conditions to be eligible for federal funding for both public and
private entities. The proposed rule will not have a significant impact
on state funds as, by law, project grants must be funded with at least
90 percent federal funds. 42 U.S.C. 300a-4(a). Furthermore, states that
are the project recipients of Title X grants are not required to issue
subawards at all. However, those that choose to do so would be required
to do so in a manner that considers only the ability of the
subrecipients to meet the statutory objectives.
States remain entirely free to set their policies and funding
preferences as to family planning services paid for with state funds.
While this proposed rule will eliminate the ability of states to
restrict subawards with Title X funds for reasons unrelated to the
statutory objectives of Title X, they remain free to set their own
preferences in providing state-funded family planning services. The
rule does not impose any additional requirements on states in their
performance under the Title X grant, other than to avoid discrimination
in making subawards, should they choose to make such subawards. And
states remain free to apply for federal program funds, subject to the
eligibility conditions. For the reasons outlined above, the proposed
rule is designed to achieve the objectives of Title X related to
providing effective family planning services to program beneficiaries
with the minimal intrusion on the ability of project recipients to
select their subrecipients.
G. Paperwork Reduction Act of 1995
The amendments proposed in this rule will not impose any additional
data collection requirements beyond those already imposed under the
current information collection requirements which have been approved by
the Office of Management and Budget.
List of Subjects in 42 CFR Part 59
Birth control, Family planning, Grant programs.
Dated: August 31, 2016.
Sylvia M. Burwell,
Secretary.
Therefore, under the authority of section 1006 of the Public Health
Service Act as amended, and for the reasons stated in the preamble, the
Department proposes to amend 42 CFR part 59 as follows:
PART 59--GRANTS FOR FAMILY PLANNING SERVICES
Subpart A--Project Grants for Family Planning Services
0
1. The authority citation for subpart A continues to read as follows:
Authority: 42 U.S.C. 300a-4.
0
2. Section 59.3 is revised to read as follows:
Sec. 59.3 Who is eligible to apply for a family planning services
grant or to participate as a subrecipient as part of a family planning
project?
(a) Any public or nonprofit private entity in a State may apply for
a grant under this subpart.
(b) No recipient making subawards for the provision of services as
part of its Title X project may prohibit an entity from participating
for reasons unrelated to its ability to provide services effectively.
[FR Doc. 2016-21359 Filed 9-2-16; 4:15 pm]
BILLING CODE 5140-34-P