Title X Family Planning: Proposed Rule on Statutory Compliance Requirements
Released: 2018-08-08T00:00:00

Introduction

The Title X Family Planning Program (Title X), enacted in 1970, is the only domestic federal program devoted solely to family planning and related preventive health services. It is administered by the Office of Population Affairs (OPA), under the Office of the Assistant Secretary for Health (OASH) within the Department of Health and Human Services (HHS). On June 1, 2018, HHS published a proposed rule in the Federal Register that would change OPA's administration of the grant program. HHS contends that the program has not been properly administered in accordance with Sections 300 to 300a-6 of title 42 of the U.S. Code (U.S.C). HHS states that the goal of the rule is to ensure that Title X funds are used within the limits set by Congress.

According to HHS, family planning projects that receive Title X funds are closely monitored to ensure that federal funds are used appropriately and are not used for prohibited activities, such as for performing surgical abortion procedures. HHS states that the agency has concerns about whether Title X projects that operate in a health care facility where abortions are provided are unintentionally crossing federal funds with funds used to cover the facility's abortion-related expenses. Furthermore, according to the proposed rule's preamble, OPA had previously misinterpreted current law by requiring Title X providers to provide abortion-related services such as counseling and referrals to their patients upon request.

The 115 th Congress is debating the scope of the program to determine whether providing an abortion-related service such as an abortion referral should be a family planning service under Title X. For example, some Members of Congress have stated that the service of providing abortion referrals is a family planning service that Title X providers should continue to provide Title X clients upon request. According to some Members of Congress, the proposed rule is a gag rule that "would bar patients from receiving information to support their ability to make informed decisions about their own reproductive health." These Members of Congress are referring to a policy originally put in place by President Reagan in 1988 that was challenged in court but upheld by the Supreme Court in 1991. The court case, Rust v. Sullivan , narrowed the scope of permissible abortion-related activities that are linked to federal funding. Congress subsequently voted to repeal the gag rule but fell short of the two-thirds majority needed to override a President George H.W. Bush veto in 1992. The Clinton Administration suspended the gag rule in January 1993. According to the Clinton Administration,

During the first 18 years of the [Title X] program, medical professionals at Title X clinics provided complete, uncensored information, including nondirective abortion counseling. In February 1988, [HHS] adopted regulations, which have become known as the "Gag Rule," prohibiting Title X recipients from providing their patients with information, counseling, or referrals concerning abortion. Subsequent attempts by the [George H.W.] Bush Administration to modify the Gag Rule and ensuing litigation have created confusion and uncertainty about the current legal status of the regulations.

Other Members of Congress state that Title X providers should not provide abortion referrals as a method of family planning. According to these Members, current regulations on abortion referrals "undermine" the statutory requirement that no Title X funds shall be used in projects "where abortion is a method of family planning." The Trump Administration has stated that "[c]ontrary to recent media reports, HHS's proposal does not include the so-called 'gag rule' on counseling about abortion that was part of the Reagan Administration's Title X rule." Members on both sides of the issue agree, however, that the proposed rule would make it harder for Planned Parenthood Federation of America (PPFA) to receive Title X funds.

To assist Congress as it considers issues related to Title X, this report

provides a brief overview of the Title X program; discusses the proposed rule's major elements and explains how the proposed rule differs from current Title X rules and guidance; provides HHS' rationale for the components of the proposed rule, as well as selected commentary from key stakeholders in reaction to the proposed rule; and summarizes HHS's regulatory impact analysis.

The Title X Family Planning Program

All 50 states, the District of Columbia, and the U.S. territories and Freely Associated States (collectively referred to as states ) are eligible to apply for Title X grants, as are other public agencies and nonprofit organizations. Grantees may use Title X dollars to establish and operate family planning projects that provide effective methods of family planning services, such as contraception, as well as infertility services. In 2016, there were 91 Title X family planning services grantees. These grantees included 48 state, local, and territorial health departments and 43 nonprofit organizations, such as community health agencies, family planning councils, and Planned Parenthood affiliates.

Grants for family planning services fund a range of family planning and related preventive health services, such as

contraceptive services; natural family planning methods; infertility services; adolescent services; breast and cervical cancer screening and prevention; sexually transmitted disease (STD) and human immunodeficiency virus (HIV) prevention education, counseling, testing, and referral ; preconception health services; and reproductive life plan counseling.

These services must be provided "without coercion and with respect for the privacy, dignity, social, and religious beliefs of the individuals being served." In FY2017, OPA used approximately 90% of Title X funds for clinical services such as those listed above, and the other 10% for activities such as personnel training and service delivery improvement research in family planning.

Current regulations require that Title X's medical services be provided under the direction of a physician with special training or experience in family planning. However, most Title X clinical service staff are not medical doctors. Title X clinical service providers include physicians, nurse practitioners, certified nurse midwives, physician assistants, and registered nurses. In 2016, of Title X's full-time equivalent (FTE) clinical service providers, 22% were physicians; 71% were nurse practitioners, certified nurse midwives, and physician assistants; and 7% were registered nurses with an expanded scope of practice.

Title X grantees can provide family planning services directly or subaward Title X monies to other public or nonprofit entities to provide services. Although no fixed matching amount is required for grants, current regulations specify that no Title X projects may be fully supported by Title X funds. In 2016, Title X grantees provided services through 3,898 clinics. That same year, Title X-funded clinics served 4.008 million clients, primarily low-income women and adolescents. Of those clients, 11% were male, 64% had incomes at or below the federal poverty guidelines, and 85% had incomes at or below 200% of the federal poverty guidelines. An earlier survey found t hat for 61% of clients, Title X-funded clinics were their "usual" or only regular source of health care. Forty-three percent of Title X clients were uninsured in 2016 .

Title X is a discretionary program (i.e., its funding is provided in and controlled by annual appropriations acts). It has received appropriations every year since the program started in FY1971. On March 23, 2018, President Trump signed the Consolidated Appropriations Act, 2018 ( P.L. 115-141 ). This law provides $286.479 million for Title X in FY2018, the same as the FY2017-enacted level. The FY2018 act continues previous years' requirements that Title X funds not be spent on abortions, among other requirements.

President Trump's FY2019 budget request, submitted February 12, 2018, includes $286.479 million for Title X, the same as the FY2018-enacted level. The FY2019 budget would continue previous years' provisions in appropriations laws prohibiting the use of Title X funds for abortion, among other requirements. On June 28, 2018, the Senate Appropriations Committee reported S. 3158 , Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3158 would fund Title X at the FY2018-enacted level, and would continue previous years' provisions in appropriations laws prohibiting the use of Title X funds for abortion, among other requirements. On July 23, 2018, the House Appropriations Committee reported H.R. 6470 , the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. H.R. 6470 would provide no funding for Title X in FY2019. During the House Appropriations Committee's bill markup, a committee amendment was defeated that would have funded Title X at the FY2018-enacted level and would have prohibited the bill's funds from being used to finalize, implement, administer, or enforce the Title X proposed rule.

Proposed Rule on Statutory Requirements

On June 1, 2018, HHS published a proposed rule in the Federal Register to revise the regulations that implement the Title X Family Planning Program. HHS accepted comments for 60 days, until July 31, 2018. Discussed below are three major elements of the proposed rule that HHS aims to modify: (1) abortion-related activities, (2) grantee requirements, and (3) pertinent definitions. Provided in each discussion of the major elements is an explanation of how the proposed rule differs from current Title X rules and guidance.

Abortion-Related Activities

Abortion Information, Counseling, and Referral

Current Requirements

On July 3, 2000, OPA released a final rule with respect to abortion-related services in family planning projects. The rule updated and revised regulations that had been promulgated in 1988. The major revision revoked the "gag rule," which restricted family planning grantees from providing abortion-related information. The regulation at 42 C.F.R. §59.5 had required, and continues to require, that abortion not be provided as a method of family planning. The July 3, 2000, rule amended the section to add the requirement that a project must give pregnant clients the opportunity to receive information and counseling on prenatal care and delivery; infant care, foster care, or adoption; and pregnancy termination. If a pregnant client requests such information and counseling, the project must give "neutral, factual information and nondirective counseling on each of the options, and referral upon request, except with respect to any option(s) about which the pregnant woman indicates she does not wish to receive such information and counseling."

Annual appropriations laws also direct that under Title X, "all pregnancy counseling shall be nondirective." The preamble to the 2000 rule described nondirective counseling:

"[G]rantees may provide as much factual, neutral information about any option, including abortion, as they consider warranted by the circumstances, but may not steer or direct clients toward selecting any option, including abortion, in providing options counseling."

Proposed Rule

The proposed rule would remove the requirement that Title X projects must provide pregnant clients with the opportunity to receive abortion-related information, counseling, and referrals upon request. According to the Chief Executive Officer (CEO) of the Christian Medical Association (CMA), a supporter of this proposed rule, "[m]ost pro-life physicians such as [CMA] members cannot refer for abortion, because of conscience and because abortion violates longstanding medical ethics such as the Hippocratic [O]ath." The preamble to the proposed rule maintains that the current requirement conflicts with several conscience protection laws and the restriction on using Title X funds "in programs where abortion is a method of family planning." The President of the American Academy of Family Physicians (AAFP), a health care professional organization, states that "the Academy respects the right of physicians to decline to participate in health care services that [they are] morally opposed to."

The proposed rule would remove the current requirement on abortion-related information, counseling, and referrals, replacing it with a requirement that projects "[n]ot provide, promote, refer for, support, or present abortion as a method of family planning." The proposed rule would also prohibit Title X projects from taking "any other affirmative action to assist a patient to secure such an abortion."

Opponents of this proposed provision, such as the National Association of Community Health Centers (NACHC) and the Guttmacher Institute, argue that this provision violates medical ethics because a pregnant client and her Title X provider would not be able to engage in an informed consent conversation. An informed consent conversation refers to a patient's access to medical information that would enable the patient to make medical decisions and ask questions about his or her care. The American Medical Association (AMA)'s Code of Medical Ethics states that "withholding medical information from patients without their knowledge or consent is ethically unacceptable." During an optimal informed consent conversation, according to AMA, health care providers should "assess the patient's ability to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision."

Under the proposed rule, Title X physicians would be permitted, but not required, to provide nondirective abortion counseling. The preamble to the proposed rule states: "Recognizing, however, the duty of a physician to promote patient safety, a doctor would be permitted to provide nondirective counseling on abortion." The preamble to the proposed rule, in a footnote, describes nondirective counseling:

Non-directive counseling does not mean the Title X provider or counselor is uninvolved in the process, nor does it mean that counseling and education offer no direction, but that clients take an active role in processing their experiences and identifying the direction of the interaction. The Title X provider/counselor promotes the client's self-awareness and empowers the client to change and develop agency over personal circumstances, offering a range of options, consistent with the client's expressed need and with the statutory and regulatory requirements governing the Title X program.

Under the proposed rule, if a pregnant client "clearly states that she has already decided to have an abortion," a "medical doctor may provide a list of licensed, qualified, comprehensive health service providers (some, but not all, of which also provide abortion, in addition to comprehensive prenatal care)." The preamble to the proposed rule notes that "the list may not identify in any way the providers that perform abortions in addition to comprehensive prenatal care." Therefore, if the rule is finalized, a Title X provider would be prohibited from knowingly referring a pregnant client to an abortion provider. All other clients may be provided, upon a request, a list of comprehensive health service providers who do not provide abortions. The proposed rule further states that all pregnant clients must be referred for prenatal and/or social services:

Because Title X funds are intended only for family planning, once a client served by a Title X project is medically verified as pregnant, she must be referred for appropriate prenatal and/or social services (such as prenatal care and delivery, infant care, foster care, or adoption), and shall be given assistance with setting up a referral appointment to optimize the health of the mother and unborn child. She must also be provided with information necessary to protect her health and the health of the unborn child until such a time as the referral appointment is kept. In cases in which emergency care is required, the Title X project shall only be required to refer the client immediately to an appropriate provider of emergency medical services.

Separating Title X Projects from Abortion-Related Activities

Current Requirements

Under 42 U.S.C. 300a-6 (Section 1008 of the Public Health Service Act), Title X funds may not be used "in programs where abortion is a method of family planning." Under current program guidelines, a grantee's abortion activities must be "separate and distinct" from the Title X project activities; however, in some cases, a grantee's Title X project activities and its abortion activities may have a common facility, a common waiting room, common staff, and a common records system:

Non-Title X abortion activities must be separate and distinct from Title X project activities. Where a grantee conducts abortion activities that are not part of the Title X project and would not be permissible if they were, the grantee must ensure that the Title X-supported project is separate and distinguishable from those other activities. What must be looked at is whether the abortion element in a program of family planning services is so large and so intimately related to all aspects of the program as to make it difficult or impossible to separate the eligible and non-eligible items of cost...

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.

Certain kinds of shared facilities are permissible, so long as it is possible to distinguish between the Title X supported activities and non-Title X abortion-related activities: (a) a common waiting room is permissible, as long as the costs are properly pro-rated; (b) common staff is permissible, so long as salaries are properly allocated and all abortion- related activities of the staff members are performed in a program which is entirely separate from the Title X project; (c) a hospital offering abortions for family planning purposes and also housing a Title X project is permissible, as long as the abortion activities are sufficiently separate from the Title X project; and (d) maintenance of a single file system for abortion and family planning patients is permissible, so long as costs are properly allocated.

Proposed Rule

The preamble to the proposed rule maintains that current guidelines create a risk of intentional or unintentional violations of Section 1008. HHS has concerns about whether Title X projects that operate in health care facilities that provide abortions are unintentionally comingling Title X funds with funds used to cover abortion-related expenses. For that reason, the proposed rule would require Title X projects to maintain physical and financial separation from abortion-related activities, including abortion provision, referral, and "activities that encourage, promote or advocate for abortion." The HHS Secretary would determine whether Title X projects have an "an objective integrity and independence" from prohibited abortion-related activities, based on several factors, including

(a) The existence of separate, accurate accounting records;

(b) The degree of separation from facilities ( e.g. , treatment, consultation, examination and waiting rooms, office entrances and exits, shared phone numbers, email addresses, educational services, and websites) in which prohibited activities occur and the extent of such prohibited activities;

(c) The existence of separate personnel, electronic or paper-based health care records, and workstations;

(d) The extent to which signs and other forms of identification of the Title X project are present, and signs and material referencing or promoting abortion are absent.

In addition, the proposed rule would prohibit the use of Title X funds to build infrastructure for prohibited abortion-related activities. Examples of infrastructure building include staff training, community outreach and recruiting, health information technology development, and obtaining physical space. This provision of the proposed rule might make it difficult for abortion providers, such as the Boulder Valley Women's Health Center and certain PPFA-affiliated health centers, to receive Title X funds. For example, Title X funds enable PPFA-affiliated health centers to provide reproductive health services to an estimated 41% of Title X clients. The proposed rule would not prohibit PPFA from applying to become a Title X grantee in the future. However, if this rule were to be finalized, some PPFA-affiliated health centers would have to restructure their current delivery of Title X services. For example, PPFA-affiliated health centers would have to refrain from providing abortion-related services in the same examination rooms that receive Title X funds. Some PPFA-affiliated health centers would also have to separate waiting rooms, entrances and exits, and websites, to maintain separation from abortion-related services.

Grantee Requirements

Reporting

Current Requirements

Current Title X regulations do not specify reporting requirements. Title X grantees are subject to several reporting requirements, but they are not laid out in the Title X regulations in the Code of Federal Regulations (42 C.F.R. 59). For example, separately from the Title X regulations, family planning services grantees are required to submit a Family Planning Annual Report (FPAR), including counts of their subrecipients and service sites. OPA is currently working to develop a new data reporting system, FPAR 2.0, which will be used to collect data directly from Title X service sites.

Annual appropriations laws state that Title X providers are not exempt from state notification and reporting laws on child abuse, child molestation, sexual abuse, rape, or incest. Program guidance requires Title X projects' training plans to include "routine" staff training on reporting requirements regarding child abuse, child molestation, sexual abuse, rape, incest, and human trafficking.

Proposed Rule

The proposed rule would require Title X grantees to report detailed information on subrecipients and referral agencies, including a "clear explanation of how the grantee will ensure adequate oversight and accountability for quality and effectiveness of outcomes among subrecipients and those who serve as referrals for ancillary or core services."

The proposed rule also states:

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").

With regard to these state notification laws, a Title X project would be required to provide documentation or assurances that it has a compliance plan. The compliance plan would include

a summary of obligations under state notification laws, including obligations to determine the ages of minor clients and minor clients' sexual partners; annual staff training; protocols to ensure that every minor who presents for treatment is counseled on how to resist attempted coercion into sexual activity; and a commitment to conduct a preliminary screening to rule out victimization after a minor under the age of consent presents with an STD, pregnancy, or any suspicion of abuse.

Under the proposed rule, Title X projects would have to maintain records demonstrating compliance with the above requirements, and the HHS Secretary may review grantees' and subrecipients' records to ensure compliance.

Services

Current Requirements

Currently, Title X projects must, among other requirements,

[p]rovide a broad range of acceptable and effective medically approved family planning methods (including natural family planning methods) and services (including infertility services and services for adolescents). 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 family planning services.

Proposed Rule

The proposed rule would remove the requirement that the provided family planning methods be "medically approved." HHS contends that "medically approved" does not appear in the Title X statute, and that the phrase may cause confusion about which approvals would be required before a method can be offered. The proposed rule would state that family planning methods include contraceptives and that infertility services include adoption. The proposed rule would also state that Title X projects are not required to provide every acceptable and effective family planning method or service. According to the President of AAFP, this proposed rule "threatens to create obstacles for patients who are trying to receive legal, medically appropriate and acceptable medical services." The current regulatory provision would be revised as follows (with italics indicating new language and strike-throughs indicating deleted language):

Provide a broad range of acceptable and effective medically approved family planning methods (including contraceptives , natural family planning and other fertility-awareness based methods) and services (including infertility services, including adoption , and services for adolescents). 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 family planning services. Such projects are not required to provide every acceptable and effective family planning method or service. A participating entity may offer only a single method or a limited number of methods of family planning as long as the entire project offers a broad range of such family planning methods and services .

This provision of the proposed rule may potentially be at tension with the Healthy People 2020 federal campaign's objective to "increase the proportion of publicly funded family planning clinics that offer the full range of methods of contraception [that are approved by the Food and Drug Administration (FDA) of HHS], including emergency contraception, onsite." In 2010, 53.6% of publicly funded family planning clinics offered a full range of FDA-approved methods of contraception onsite. The federal campaign seeks to reach a target of 67% by 2020.

Family Participation and Minors

Current Requirements

Appropriations laws require grantees to certify that they encourage "family participation" when minors seek family planning services and to certify that they counsel minors on how to resist attempted coercion into sexual activity. Title X program guidance instructs grantees to comply with these and other appropriations act mandates. Under OPA's FY2018 Title X funding opportunity announcement (FOA), a client under the age of consent will be subject to a preliminary screening to rule out victimization after he or she presents with an STD, pregnancy, or any suspicion of abuse. This requirement is not in current regulations. For the purposes of determining eligibility for Title X discounts or free services, current rules state that "unemancipated minors who wish to receive services on a confidential basis must be considered on the basis of their own resources."

Proposed rule

Under the proposed rule, minors who want confidential services would continue to be considered on the basis of their own resources. Regarding the medical records of minors, projects would have to document how they encouraged "family participation" in a minor's decision to seek family planning services (unless the minor is a suspected victim of abuse or incest).

The proposed rule would require that Title X providers conduct preliminary screenings on clients who are under the age of consent. OPA's FY2018 FOA has a similar requirement. The goal of the preliminary screening is to rule out victimization after a client presents with an STD, pregnancy, or any suspicion of abuse. In the United States, the two most common forms of STD that are reported for youth aged 0-19 are chlamydia and gonorrhea (see Table 1 ).

Current Requirements

Current regulations require Title X projects to provide for "necessary referral to other medical facilities when medically indicated" and "coordination and use of referral arrangements with other providers of health care services, local health and welfare departments, hospitals, voluntary agencies, and health services projects supported by other federal programs." Current program guidance further states that "providers of family planning services that do not have the capacity to offer comprehensive primary care services should have strong links to other community providers to ensure that clients have access to primary care."

Proposed Rule

The proposed rule would add a new requirement on access to comprehensive primary care, either onsite or in close physical proximity:

In order to promote holistic health and provide seamless care, Title X service providers should offer either comprehensive primary health services onsite or have a robust referral linkage with primary health providers who are in close physical proximity to the Title X site.

Title X- funded clinics serve primarily low-income women and adolescents. The lack of transportation for this population is an access barrier to care. In view of that fact, some Title X clients were offered public transportation vouchers worth $5 in exchange for their participation in a study on health insurance coverage of contraception at Title X-funded clinics . In an older study of family planning clinics in four states, 77% of Title X clinics reported that they either provided transportation assistance (such as ride services or subsidized taxis) or were accessible by public transportation. According to the Department of Transportation, lack of transportation causes approximately 3.6 million people to miss or arrive late to medical appointments in the United States annually. This new requirement may increase some Title X clients' access to care by removing some of their need for transportation.

Some commentators suggest that the proposed rule may shift demand for health care services from PPFA-affiliated health centers, to federally qualified health centers (commonly referred to as health centers and community health centers ). According to the National Association of Community Health Centers (NACHC), the adoption of the proposed rule would cause confusion among community health centers that are Title X grantees. NACHC states that

[h]ealth centers are trusted providers in their communities. It is imperative that health center patients feel confident that they are receiving comprehensive, medically-informed and accurate information about health care from their doctors at all times. Should this proposed rule be adopted, health centers would have to choose between allowing federal regulations to dictate what they can and must discuss with their patients, and losing a critical source of revenue to support patient care. Either way, patients would not be well-served.

Nevertheless and according to the CEO of Americans United for Life, a supporter of the proposed rule,

Women can do much better than Planned Parenthood. Comprehensive, preventive healthcare centers outnumber Planned Parenthood 20 to 1, and that's where women receive genuine expert care without the shadow of abortion hanging over them.

In 2015, the Guttmacher Institute surveyed a nationally representative sample of publicly funded family planning clinics. Respondents included 535 Title X clinics. Based on that survey, an estimated 38% of Title X clinics reported providing primary care services.

Pertinent Definitions

Family Planning

Current Requirements

Neither the Title X statute nor the existing regulations define "family planning." A core set of family planning services is defined in program guidance, "Providing Quality Family Planning Services: Recommendations of CDC and the U.S. Office of Population Affairs," which states,

Family planning services include the following:

--providing contraception to help women and men plan and space births, prevent unintended pregnancies, and reduce the number of abortions;

--offering pregnancy testing and counseling;

--helping clients who want to conceive;

--providing basic infertility services;

--providing preconception health services to improve infant and maternal outcomes and improve women's and men's health; and

--providing sexually transmitted disease (STD) screening and treatment services to prevent tubal infertility and improve the health of women, men, and infants.

Proposed Rule

The proposed rule would add a new definition:

"Family planning" means the voluntary process of identifying goals and developing a plan for the number and spacing of children and the means by which those goals may be achieved. These means include a broad range of acceptable and effective choices, which may range from choosing not to have sex to the use of other family planning methods and services to limit or enhance the likelihood of conception (including contraceptive methods and natural family planning or other fertility awareness-based methods) and the management of infertility (including adoption). Family planning services include preconceptional counseling, education, and general reproductive and fertility health care to improve maternal and infant outcomes, and the health of women, men, and adolescents who seek family planning services, and the prevention, diagnosis, and treatment of infections and diseases which may threaten childbearing capability or the health of the individual, sexual partners, and potential future children). Family planning and family planning services are never coercive and are strictly voluntary. Family planning does not include postconception care (including obstetric or prenatal care) or abortion as a method of family planning. Family planning, as supported under this subpart, should reduce the incidence of abortion.

The preamble to the proposed rule states that physical examinations, breast and cervical cancer screenings, STD and HIV testing, and pregnancy testing and counseling would continue to be authorized under this definition as part of "general reproductive and fertility health care."

Low-Income Family

Current Requirements

Priority for Title X services is given to persons from low-income families, who may not be charged for care. Current regulations define low-income family as having income at or below 100% of the federal poverty guidelines. The guidelines vary by family size and are updated annually for inflation (with some adjustments for rounding). The 2018 federal poverty guideline for one person in the contiguous 48 states and the District of Columbia is $12,140 and increases by $4,320 for each additional person. The regulation states that "[l]ow-income family also includes members of families whose annual family income exceeds this amount, but who, as determined by the project director, are unable, for good reasons, to pay for family planning services. For example, unemancipated minors who wish to receive services on a confidential basis must be considered on the basis of their own resources."

Proposed Rule

The proposed rule would expand the definition of "low-income family" to include women who cannot get job-based contraception coverage due to their employer's religious or moral objection:

With respect to contraceptive services, a woman can be considered from a "low-income family" if she has health insurance coverage through an employer which does not provide the contraceptive services sought by the woman because it has a sincerely held religious or moral objection to providing such coverage.

Expansion of this definition would increase the Title X client population that could receive free contraceptives. If finalized, certain women would be eligible for free contraceptives regardless of their own or their family's income. Thus, changing the definition of "low-income family" may likely increase access to free contraception services for these women. This change may also increase Title X grantees' need for additional federal funds.

The proposed rule does not address whether or not priority for contraceptives would be given to women with incomes at or below the federal poverty level, versus the potential newly eligible women with higher annual incomes. Moreover, the preamble does not define the criteria that an employer must meet to be recognized as "sincerely [holding] religious or moral objections to providing [contraceptive] coverage."

Regulatory Impact Analysis

In its regulatory impact analysis, OPA estimates that the proposed rule would cost $45.5 million in 2019 and $14.6 million in subsequent years (2020 to 2023). With respect to the physical separation requirements, OPA estimates that between 10% and 20% of Title X service sites do not comply and would have to incur costs to come into compliance. Costs would also be incurred for activities such as training, documentation, monitoring, enforcement, and reporting.

OPA states that the proposed rule is expected to result in several benefits, including assurance that tax dollars are being used in compliance with the law, increased patient access, improved quality of services, and an expanded and more diverse field of medical professionals. According to the preamble, some of these benefits would stem from the conscience-related provisions:

For providers, the proposed regulation is expected to create benefits through respect for conscience. It would do so by better aligning the Title X regulations with the statutory prohibitions on discrimination against health care entities, including individual health care providers, who refuse to participate in abortion–related activity such as counseling and referrals. Potential grantees, and subrecipients that refuse to provide abortion counseling and referrals may now be eligible and interested in applying to provide family planning services under the current Title X regulations.

Current Title X regulations might discourage some potential Title X grantees from applying. Some potential Title X grantees might not apply because current grantees must provide abortion referrals upon request. This requirement may clash with the religious and moral beliefs held by some potential grantees. For that reason, the finalization of this proposed rule might encourage more potential Title X grantees that hold such beliefs to apply.

The preamble further states that "the expansion of provider and family planning options would have salutary benefits for patients, including for patients who seek providers who share their religious or moral convictions." A study of 1,430 religious reproductive-aged women (18-45 years old) found that 34.5% of the women felt that it was somewhat or very important to know about a hospital's religious affiliation. That same study also found that 80.7% of the religious women felt that it was somewhat or very important to know about a hospital's religious restrictions on reproductive care, prior to seeking the care.

Compliance Dates

The proposed rule would require Title X projects to comply with its physical separation requirements one year after the final rule's publication. For other requirements, compliance would be required 60 days after the final rule's publication.