BCHC Comments on Title X Rulemaking

May 14, 2021

Office of Population Affairs
Office of the Assistant Secretary for Health
US Department of Health and Human Services
200 Independence Avenue SW
Washington, DC 20201

Attn: Title X Rulemaking

I write on behalf of the Big Cities Health Coalition (BCHC),a forum for leaders of America’s largest metropolitan health departments to exchange strategies and collaboratively address issues to promote and protect the health and safety of the nearly 62 million people they serve. BCHC is pleased to provide comments to the US Department of Health and Human Services’ (HHS) notice of proposed rulemaking (NPRM), “Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services,” RIN 0937-AA11.

These large local public health departments work every day in their communities to prevent disease, promote wellness, and protect health. They convene community partnerships and facilitate important conversations with diverse stakeholders on how to create the conditions in which all people can be healthy. One of the services provided by many big city health departments is ensuring access to a broad range of family planning and comprehensive preventive health services to communities through the Title X program. The nation’s premier family planning program, Title X provides access to affordable birth control, sexually transmitted infection (STI) testing and treatment, HIV testing, cancer screenings, and other critical preventive health services to individuals with low incomes. For nearly fifty years, the program has provided these critical services to those who need them most, including people of color, young people, LGBTQ people, immigrants, and those in rural communities who have limited access to health care services.

More than half of Title X family planning grantees are local and state health departments. Further, health departments that are not Title X grantees work alongside the funded entities to ensure services such as family planning and STI/HIV testing (and prevention) are available to in communities across the country. Unfortunately, recent changes to the Title X program have limited its effectiveness and reach as Title X providers, including some governmental public health departments and their community partners, were forced to cut back services or close their clinic doors.

Besides increasing burdens on patients, it is simply unworkable for many providers to physically separate their family planning services from other public health services provided to community members, including immunizations, maternal and child health services, and nutrition programs. It is even more of a burden for government agencies to separate their billing and electronic health records, not to mention administrative oversight (such as legal or accounting services), which is cost prohibitive and a waste of public dollars.

As such, BCHC strongly supports HHS’s NPRM revoking the 2019 Title X regulations (the 2019rule) and reinstating the 2000 regulations with some revisions. Once finalized, the proposed rule would return Title X to its proper focus on “making comprehensive voluntary family planning services readily available to all persons desiring such services.” Furthermore, because of the devastating impact of the 2019 Title X regulations on the program’s provider network and its patients, BCHC supports finalization of the proposed rule as quickly as possible.

BCHC agrees with HHS’s statement in the NPRM that “the 2019 rule was a solution in search of a problem, a solution whose severe public health consequences caused much greater problems.” When the 2019 rule was implemented, grantees immediately began to withdraw from Title X rather than comply with the 2019 rule’s requirements. Overall, as the proposed rule notes, the Title X program lost more than 1,000 health centers. Those health centers represented approximately one quarter of all Title X-funded sites in 2019. Nearly two years later, six states continue to have no Title X-funded provider network (Hawaii, Maine, Oregon, Utah, Vermont, and Washington), and an additional six have a very limited Title X-funded network (Alaska, Connecticut, Massachusetts, Minnesota, New Hampshire, and New York). The significant damage to the Title X provider network resulted in at least 1.5 million patients losing access to Title X-funded services.

Despite the Trump administration’s assertion that the 2019rule would cause new applicants to apply for Title X funding and result in “more clients being served,” OPA has been unable to find new grantees to fill the gaps the 2019 rule created, including in the six states that lost all Title X-funded services, and has ultimately served far fewer clients rather than more.

As HHS rightly calls out in the proposed rule, federal data shows the rapid and devastating impact of the 2019rule on access to critical family planning and sexual health services. Title X saw 844,083 fewer patients in 2019 compared to 2018 (3.1 million vs. 3.9 million). That dramatic 21% drop in patients was seen with the 2019 rule only in effect for less than half of the year. This decrease meant that providers were able to offer 280,000 fewer cancer screenings, 1.3 million fewer STI screenings, and 278,000 fewer confidential HIV tests. Additionally, hundreds of thousands of people lost access to contraceptive care due to the rule. The preliminary numbers for 2020 as shared in the proposed rule are even worse –only an estimated 1.5 million people received Title X-supported services in 2020, a loss of 2.5 million people from the network in just two years.10In a 2016 study, six in ten women seeking contraceptive services at a Title X-funded health center reported that to be their only source of medical care in the past year.11Thus, this kind of precipitous decline in patients receiving services through the Title X program has concerning implications for broader access to care.

The 2019 Title X rule severely undermined this bedrock public health program that has provided high quality, affordable family planning and sexual health care to millions for 50 years. BCHC strongly supports the revocation of the 2019 rule, and reinstatement of the 2000 regulations with revisions, so that the Title X program, including local health departments and their partners, can return focus to patients and communities.

Health Equity

BCHC strongly supports the administration’s emphasis on health equity in the proposed rule. The statutory requirements that Title X-funded health centers prioritize people with low-incomes, and provide care regardless of ability to pay, ensure that the Title X program is well-positioned to advance health equity for the patients it serves. However, the onerous requirements of the 2019 rule diverted attention and resources from this important work and undermined Title X’s mission to provide equitable, affordable, client-centered, quality family planning and sexual health services.

BCHC strongly supports the additions the proposed rule makes to the definitions in the Title X regulations, including definitions for health equity and inclusivity. BCHC member cities have led the way in recognizing the role that systemic discrimination plays in health and emphasizing the need for cultural competency, health equity, and inclusion of all residents. We appreciated, in particular, the transition from using the word “women” to the more inclusive “client,” which is more reflective of the diverse population of patients served by the Title X program. Gender identity should never be a barrier to receiving the care one needs and all people who are capable of becoming pregnant, including queer, transgender, and nonbinary people, may have a need for family planning care, just as their sexual partners may. The proposed rule’s definitions help to illustrate key aspects of quality care including the importance of client-centeredness; culturally and linguistically appropriateness; and recognition of how trauma affects people. Defining how services should be provided is an important step towards a more equitable Title X program.

The COVID-19 pandemic has laid bare the many inequities in our nation’s health care system and highlighted how systemic racism and other forms of oppression have resulted in pervasive health disparities and disproportionately poor health outcomes for people of color. The Title X program has a significant role to play in combating these systemic barriers to care and ensuring that all people, regardless of their race, ethnicity, age, sexual orientation, gender identity, immigration status, employer, insurance status, or any other demographic, have timely access to comprehensive, high-quality family planning and sexual health services. The proposed rule’s emphasis on health equity will further support these goals.

Particularly in the wake of CDC’s recent declaration that racism is a serious threat to public health, BCHC would like to see systemic racism explicitly included and addressed as part of the expectations related to health equity. Systemic racism and other forms of oppression have resulted in structural barriers to health care services. The Title X family planning program and today’s provision of family planning services arose out of a history of reproductive coercion and a fundamental devaluing of the bodily autonomy of people of color and people with low incomes. This history has contributed to a justifiable mistrust of the health care system, particularly with respect to family planning. As the administration raises health equity as an important goal of Title X in the proposed rule, BCHC urges HHS to acknowledge and reckon with that history as a part of that work.

State Restrictions on Provider Networks

BCHC strongly supports ensuring that Title X projects do not undermine the program’s mission by excluding otherwise qualified providers as subrecipients. Despite mounting evidence that expelling well-qualified, trusted family planning providers from publicly funded health programs like Title X has adverse effects on patients’ access to critical family planning and sexual health care, states in recent years have increasingly targeted some family planning providers for exclusion from key federal health programs, including Title X. At least 15 states currently have laws on the books that, where funds flow through the state government, could negatively impact the Title X service delivery network. Two additional states have similar bills that are likely to become law this year. Tiering and other prohibitions against family planning providers often exclude the very providers that are the most qualified and best-equipped to help Title X patients achieve their family planning goals.

The NPRM appropriately recognizes that “state policies restricting eligible subrecipients unnecessarily interfere with beneficiaries’ access to the most accessible and qualified providers,” and that “denying participation by family planning providers that can provide effective services has resulted in populations in certain geographic areas being left without Title X providers for an extended period of time.” BCHC strongly agrees with HHS that “state restrictions on subrecipient eligibility unrelated to the ability to deliver Title X services undermine the mission of the program to ensure widely available access to services by the most qualified providers.”

The intent of the Title X program is to help individuals—regardless of their economic status, but prioritizing low-income individuals—achieve their family planning goals. Title X funding is therefore provided to public and nonprofit entities to “assist in the establishment and operation of voluntary family planning projects” that offer a broad range of effective family planning methods and services. As noted in the NPRM, “[P]roviders with a reproductive health focus often provide a broader range of contraceptive methods on-site and therefore may reduce additional barriers to accessing services.”

To best achieve the program’s goals, Title X has historically funded a diverse network of service delivery providers—including state, county, and local health departments, as well as hospitals, family planning councils, Planned Parenthood affiliates, federally qualified health centers, and other private non-profit organizations. These networks vary widely across communities because they are specifically established to provide the most effective care to their specific patient populations. It is therefore imperative that HHS “ensure that Title X projects do not undermine the program’s mission by excluding otherwise qualified providers as subrecipients.”

Confidentiality

Two interrelated hallmarks of Title X have been the program’s historically strong protections for patient confidentiality and its commitment to serving adolescents. Since the 1970s, federal law has required that both adolescents and adults be able to receive confidential family planning services in Title X projects. Research shows these confidentiality protections are one of the reasons individuals choose to seek care at Title X sites.

Family planning services address some of the most sensitive and personal issues in health care and therefore require strong confidentiality protections. Patients seeking family planning services encompass a broad spectrum of patient populations. Certain groups, including adolescents and young adults, and people at risk of domestic or intimate partner violence, have special privacy concerns that require particularly strong protection.

The 2019 Title X rule weakened these protections by requiring providers to encourage family involvement even when it could be harmful, by giving the HHS Secretary oversight authority in the enforcement of complex and nuanced state reporting laws, and by adding new inappropriate reporting and documentation obligations on providers. In so doing, the 2019 rule undermined the provider-patient relationship to the detriment of public health.

The NPRM would reinstate the Title X confidentiality regulations in place prior to the 2019 rule while making important improvements. First, the NPRM eliminates the 2019 rule’s unnecessary and harmful requirements to take and document specific actions to encourage family involvement in the family planning decision-making of adolescents, without including the statutory limitation “[t]o the extent practicable” and with complete disregard for the expertise, training, and experience Title X providers already use in assisting adolescents to involve their families in decisions about family planning services and other key health care matters when realistic and appropriate.

Second, the NPRM eliminates the 2019 rule’s attempt to give HHS substantial oversight over compliance with complex state reporting requirements concerning child abuse, child molestation, sexual abuse, rape, incest, or human trafficking. Combined with the 2019 rule’s requirements to collect and document specific information in Title X records, as well as that rule’s attempt to give HHS the authority to impose harsh penalties if HHS (not the state) believes a Title X project is out of compliance, the 2019 rule pushed providers toward inappropriate screening and over-reporting that would harm patients and undermine the provider-patient relationship, ultimately resulting in fewer patients seeking critical health services.

Determinations regarding compliance with state reporting laws properly rest with state authorities. State reporting laws are complex and vary widely from state to state. They seek a nuanced balance between the need to protect those who experience abuse and ensure that law enforcement can bring victimizers to justice with the need to ensure that patients are able to seek critical health care services they might avoid if they do not trust their health care provider. Thus, many state laws include both specific requirements that clearly trigger an obligation to make a report and others that allow for the exercise of discretion by health care professionals.

Third, the NPRM adds important clarification to how Title X-funded entities are to balance client confidentiality with the program’s statutory requirement that “no charge will be made in such project or program for services provided to any person from a low-income family except to the extent that payment will be made by a third party (including a government agency) which is authorized or is under legal obligation to pay such charge.”

BCHC welcomes the NPRM’s addition of language codifying a longstanding practice that had been included in the 2014 Title X Program Requirements that reasonable efforts must be made to “collect charges without jeopardizing client confidentiality,” along with a new requirement that clients be informed of “any potential for disclosure of their confidential health information to policyholders where the policyholder is someone other than the client.” HHS is right to recognize the potential for harm from varied state and local laws regarding the accessibility of client information to insurance policyholders that are not the client. As more and more patients have access to insurance, the potential risks of disclosure of sensitive information have increased. These proposed additions to the Title X regulations will help to ensure that confidentiality remains paramount in Title X.

The NPRM proactively addresses the potential within the Title X regulations themselves for harm related to disclosure of a client’s sensitive information to third parties such as policyholders who are not the client. In addition, HHS should evaluate Title X’s interaction with other laws and regulations for possible conflicts that could undermine Title X clients’ confidentiality and potentially subject them to harm.

Purpose of the program/standard of care

Title X was expressly created in 1970 to make “‘comprehensive family planning services readily available to all persons desiring such services.” Specifically, many low-income women had more children than they desired, because both the pill and the other most effective contraceptive method at the time, the copper intrauterine device (IUD), were both expensive medical methods. Congress enacted Title X to help those “medically indigent” persons –low-income individuals who desired but could not access the contraceptive methods that more affluent members of society could, and who were: forced to do without, or to rely heavily on the least effective nonmedical techniques for fertility control unless they happen to reside in an area where family planning services are made readily available by public health services or voluntary agencies.

For this reason, the statute requires Title X projects to “offer a broad range of acceptable and effective family planning methods and services,” and prioritizes a project’s capacity to make rapid and effective use of federal funds for family planning. The 2019 rule undermined this longstanding standard of care in a variety of ways: It eliminated the term “medically approved” from the longstanding regulatory requirement that projects provide “a broad range of acceptable and effective medically approved family planning methods;” included overly permissive language that opened the door to participation in the program by providers who object to fundamental tenets of the Title X program, and diverged from the nationally recognized clinical standards, the Quality Family Planning guidelines, published by the Office of Population Affairs and the Centers for Disease Control and Prevention in 2014. Furthermore, the 2019 rule made drastic changes to pregnancy counseling by Title X providers that violated Congress’ explicit, repeated mandates; contradicted central principles of medical ethics; and attempted to enlist clinicians in deceiving and delaying patients who seek information about or access to abortion providers.

BCHC applauds HHS for the proposed rule’s return to the core mission of the Title X program, and will once again match patients’ expectations that they will receive high-quality client-centered care that includes comprehensive, medically accurate counseling and information, and referrals for any other services sought.

Specifically, BCHC strongly supports the following changes and urges the Administration to finalize them:

• The inclusion of “FDA-approved contraceptive services” and reinstatement of the term “medically approved” to the proposed definition of family planning services;
• The requirement that Title X service sites refer patients out if the site does not offer the contraceptive method of the patient’s choice;
• Provide services “in a manner that is client-centered, culturally and linguistically appropriate, inclusive, and trauma-informed; protects the dignity of the individual; and ensures equitable and quality service delivery consistent with national recognized standards of care;”
• The reinstatement of the requirement to offer nondirective options counseling to pregnant patients on each of the three options, if requested by the patient, including referral upon request.
• The elimination of unnecessary, unworkable physical, systems, and administration separation, contrary to the requirements and realities of modern quality health care.

Modernizing the Title X regulations is important to the program’s future success

Despite the Title X program’s success over the course of the program’s history, including the nearly two decades spent operating under the 2000 regulations that serve as the basis of this NPRM, changes in the health care delivery landscape necessitate updates to the Title X regulations to account for the context in which services currently are delivered in the family planning safety net.

The NPRM makes an important update in § 59.5(b)(1) in recognition that medical services in many Title X-funded health centers can be and are provided by health care providers who are not physicians. In fact, the NPRM preamble specifically mentions physician assistants and nurse practitioners as the types of health care providers that provide consultation in Title X settings. Indeed, nurse practitioners, certified nurse midwives, and physician assistants accounted for 67% of the Title X program’s full-time equivalent (FTE) Clinical Services Provider (CSPs) in the 2019; physicians and registered nurses with an expanded scope of practice accounted for 24% and 9% of all CSP FTEs, respectively.

However, it is important to note that “consultation by a [health care] provider” is not and should not be limited only to the examples cited by HHS, as these CSPs represent only one facet of health care providers in Title X settings. In 2019, 23% -or more than 1.07 million –of family planning encounters fell under the primary responsibility of other service providers, including registered nurses practicing within a standard scope of practice, licensed practical nurses, health educators, and social workers. These professionals not only account for a substantial number of Title X encounters on their own, but also provide critical support to CSPs in team-based care models typical to modern health care delivery. They are more likely to be Black, Indigenous, and People of Color (BIPOC)—racial/ethnic groups that are both persistently underrepresented in health care professions and more reflective of clients served through the Title X program. BCHC encourages HHS to elevate the critical role these health care professionals play in the Title X program.

Among enhancements to the 2000 regulations proposed in the NPRM, HHS specifically highlights “telemedicine.” The importance of telehealth, more broadly, has been growing in recent years and has become particularly clear in the context of the COVID-19 public health emergency. Since spring 2020, use of telehealth modalities has allowed tens –if not hundreds –of thousands of Title X users to remotely access many Title X services without placing themselves at increased risk for potential COVID-19 exposure.

That said, the Department’s use of the term “telemedicine” in the NPRM instead of “telehealth” is of concern, with “telehealth” referring to a broader scope of remote health care services than telemedicine and includes non-clinical services like counseling and education. Accordingly, in addition to its change from “physician” to “[health care] provider” in § 59.5(b)(1), HHS can further improve the Title X regulations by explicitly naming and defining “telehealth” to clarify that section as follows:

59.5(b)(1): Provide for clinical and other qualifying services related to family planning (including consultation by a healthcare provider, family planning counseling and education, examination, prescription, and continuing supervision, laboratory examination, contraceptive supplies), in person or via telehealth, including audio-only modalities, regardless of the patient’s or provider’s setting, and necessary referral to other medical facilities when medically indicated, and provide for the effective usage of contraceptive devices and practices.

The NPRM also proposes making a “technical correction” to § 59.12 to include 45 CFR part 87, the ‘‘Equal Treatment for Faith-based Organizations’’ rule (faith-based organizations rule) in the list of regulations that apply to Title X. The previous administration, which finalized the faith-based organizations rule on December 17, 2020, explicitly declined to apply this rule to Title X. Furthermore, the faith-based organizations rule, finalized on December 17, 2020, insofar as it applies to HHS grant programs, only “applies to grants awarded in HHS social service programs.” As Title X is a health service program, with grants made to 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,” 45 CFR part 87 does not rightfully apply, and should therefore not be included in the final Title X rule.

For 50 years, the Title X family planning program has been a critical underpinning of the public health safety-net infrastructure that serves millions of low-income people each year. We appreciate HHS’s dedication to improving the public’s health. We would be happy to discuss these comments and recommendations with you further. Please do not hesitate to contact me at juliano@bigcitieshealth.org.

Regards,

Chrissie Juliano, MPP
Executive Director