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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations number felt that the 2019 rule negatively impacted the number of clients served and that the proposed rule will increase the number of clients served. Many comments supported being able to expand access to Title X
services across the nation and within states and territories. They felt that the proposed rule will result in more Title X grantees and service sites and will increase the diversity of grantees. Many other comments expressed support that the proposed rule will increase health equity and decrease health disparities by increasing the number of marginalized and vulnerable groups served by Title X.
Many comments expressed a belief that the proposed rule will result in improved health outcomes and that the 2019 rule had a negative impact on public health. Others supported the emphasis in the proposed rule on quality family planning and felt that the proposed rule will result in improved quality of care. Many comments expressed a belief that the proposed rule better aligns with the mission of Title X
and that it will result in cost savings.
Of those that oppose the proposed rule, many expressed general opposition to the elimination of the 2019 rule, and a large number expressed a belief that the proposed rule does not align with the mission of Title X. Several comments expressed a belief that the proposed rule will result in negative health outcomes. A small number of comments raised concern that the proposed rule will result in a decrease in quality of care and would cost more to implement compared to the 2019
rule.
The Department also received several comments that were not relevant to the 2021 rule. These included several comments expressing opposition to the use of hormone therapy for adolescents, a few comments requesting that the Department include specific services within Title X that are already included in Title X e.g., STI testing, cervical cancer prevention and treatment, and several personal testimonials either for or against family planning in general, but not specific to the 2021 rule.
Response: The Department agrees with the comments in support of the proposed rule and disagrees with the comments opposed to the proposed rule. The Department believes that the negative public health consequences of the 2019 rule are clear. As stated in the Background section, the 2019 rule dramatically reduced access to essential family planning and preventive health services for hundreds of thousands of clients, especially for the low-income clients Title X was specifically created
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to serve. The 2019 rule decreased the number of providers willing to participate in the Title X program, further reducing access to essential family planning services within states and communities across the country.
The 2019 rule shifted Title X away from its history of providing client-centered, quality family planning services and instead set limits on the patientprovider relationship and the information that could be provided to the patient by the provider. The 2019
rule resulted in increased costs for grantee reporting that are unnecessary for ensuring grantee compliance. The Department believes that continued enforcement of the 2019 rule raises the possibility of a two-tiered healthcare system in which those with insurance and full access to healthcare receive full medical information and referrals, while low-income populations with fewer opportunities for care are relegated to inferior access.
The Department will continue to enforce and monitor grantee compliance with all Title X statutory requirements and legislative mandates. The Department disagrees with comments that it is necessary to include language repeating the legislative mandates within the regulation itself. As noted above with respect to Section II. C.
Grantee and Subrecipient Compliance, OPA explicitly states in NOFOs that all grantees must comply with the Title X
statute, regulations, and legislative mandates, and applicants certify in the application materials that they will comply with federal law; compliance with program statutes and appropriations act requirements is also included as a standard term of the Title X grant award. Therefore, during the application process as well as by accepting funds, grantees have assured their compliance to the statute, regulations, and legislative mandates.
Furthermore, OPA includes the legislative mandates in its grantee orientation and trainings and regularly monitors grantee compliance with the legislative mandates through grantee reporting and compliance monitoring visits.
The Department believes that the adoption of the 2021 proposed rule 86
FR 19812, April 15, 2021, with minor modifications discussed in this rule, will result in increased access to equitable, affordable, client-centered, quality family planning services. This will result in improved outcomes for all clients served by Title X. Additionally, the 2021 rule will ensure that the predominantly low-income clients who rely on Title X services as their usual source of medical care have access to
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the same quality healthcare, including full medical information and referrals, that higher-income clients and clients with private insurance are able to access.
Comments Regarding Proposed Revisions and Technical Corrections to the 2000 Regulation 59.2. Definitions In the NPRM, the Department proposed revising section 59.2 of the 2000 regulations by adding several new and modified definitions. The NPRM
included a new definition of family planning services consistent with the definition included in QFP. The NPRM
also included a new definition of service site consistent with the previous Title X Family Planning Guidelines that implemented the 2000 regulations, the 2014 Program Requirements for Title X
Funded Family Planning Projects 2014
Title X Program Requirements.
Finally, the NPRM included new definitions for adolescent-friendly health services, client-centered care, culturally and linguistically appropriate services, health equity, inclusivity, quality healthcare, and trauma-informed services. All new definitions included in the NPRM were taken from federal government agencies or major medical associations. The NPRM also retained definitions from the 2000 regulation for the following terms: Act, family, lowincome, non-profit, Secretary, and state.
Comments: The Department received numerous comments in support of the new or revised definitions in the NPRM.
Many comments expressed strong general support for the newly-proposed definitions, including definitions for client-centered care, cultural and linguistic appropriateness, family planning services, health equity, inclusivity, and trauma-informed.
Numerous comments stated that the proposed rules definitions help to illustrate key aspects of quality care and that defining how services should be provided is an important step toward a more equitable Title X program.
Numerous comments expressed specific support for the emphasis on health equity in the proposed rule. Comments expressed that the added definition for health equity underscores the goal of ensuring that all Title X patients have the opportunity to attain their full health potential. Many comments also expressed support for the definition of family planning services, and specifically the inclusion of FDAapproved contraceptive products and reinstatement of the term medically approved to the definition. Several comments were supportive of not
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