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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations medical organizations. The Department also disagrees that the definition of inclusive will drive faith-based organizations out of Title X or that it will segregate services; rather, the goal is to ensure that all people can actively participate in and benefit from family planning services. Finally, the Department disagrees with comments opposing the use of the word client and believes that it is important that the words used in Title X fully reflect the diversity of Title X clients.
In conclusion, the Department adopts the definitions from the NPRM for this provision as final with one revision and one technical correction. Given the revisions described later to 59.5b1
and 59.5b6 to include reference to clinical services providers in the regulatory text, the Department is adding a definition for clinical services provider to the final rule in 59.2. The definition of clinical services provider comes from OPAs FPAR and has been widely used as a definition for Title X
grantees to guide their FPAR data collection and reporting. As taken from FPAR, a clinical services provider is defined as physicians, physician assistants, nurse practitioners, certified nurse midwives, and registered nurses with an expanded scope of practice who are trained and permitted by statespecific regulations to perform all aspects of the user male and female physical assessments recommended for contraceptive, related preventive health, and basic infertility care.
One technical correction in the final rule is to the definition of family planning services. The definition in the NPRM stated, Family planning services include a broad range of medically approved contraceptive services, which includes Food and Drug Administration FDA-approved contraceptive services and natural family planning methods, for clients who want to prevent pregnancy and space births, pregnancy testing and counseling, assistance to achieve pregnancy, basic infertility services, sexually transmitted infection STI services, and other preconception health services. Since the FDA does not approve contraceptive services, but rather approves, clears, and authorizes for purposes of this rulemaking, FDA-approved contraceptive products, the definition in the final 2021 rule is revised. The final definition will now read, Family planning services include a broad range of medically approved services, which includes FDA-approved contraceptive products and natural family planning methods, for clients who want to prevent pregnancy and space births, pregnancy testing and counseling,
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assistance to achieve pregnancy, basic infertility services, sexually transmitted infection STI services, and other preconception health services.
In addition to this revised definition for family planning services, the definitions from the NPRM for Act, adolescent-friendly health services, client-centered care, culturally and linguistically appropriate services, family, health equity, low-income, inclusive, non-profit, quality healthcare, Secretary, service site, state, and trauma-informed are all adopted as final.
59.5a1. Broad Range of Acceptable and Effective Medically Approved Family Planning Methods and Services In the NPRM, the Department proposed revising section 59.5a1 of the 2000 regulation to require sites that do not offer the broad range of methods on-site to provide clients with a referral to a provider who does offer the clients method of choice. In addition, the NPRM specified that the referral must not unduly limit the clients access to their method of choice. The complete NPRM language for this provision stated, Provide a broad range of acceptable and effective medically approved family planning methods including natural family planning methods and services including pregnancy testing and counseling, assistance to achieve pregnancy, basic infertility services, STI services, preconception health services, and adolescent-friendly health services. If an organization offers only a single method of family planning, it may participate as part of a project as long as the entire project offers a broad range of acceptable and effective medically approved family planning methods and services. Title X service sites that are unable to provide clients with access to a broad range of acceptable and effective medically approved family planning methods and services, must be able to provide a referral to the clients method of choice and the referral must not unduly limit the clients access to their method of choice. The proposed revisions recognized that while an organization that offers only a single method of family planning may participate as part of a Title X project, as long as the entire project offers the broad range of methods and services, offering only a single method of family planning could impact client access.
Comments: The Department received many comments in support of section 59.5a1, especially in support of the requirement that Title X projects provide a broad range of acceptable and effective medically approved family
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planning methods. Many comments expressed support for reinstating the term medically approved to the provision. Several comments requested that the Department add more specificity to the regulations to further define what is meant by a broad range of methods. One comment requested that the Department expect Title X
agencies to offer many or almost all of the most commonly used methods, and use referrals as an option of last resort.
Another comment requested the Department to require each site to have at least one type of each provideradministered method in stock, and to have a process in place to offer other methods of contraception by prescription if not stocked in the clinic.
The Department also received many comments expressing concern about allowing an organization to participate as part of a Title X project if it only offers a single method of family planning, as long as the entire project offers a broad range of acceptable and effective medically approved family planning methods and services. Several comments expressed concern that allowing Title X sites to offer a single method of contraception conflicts with Quality Family Planning standards and HHS stated goals regarding quality, client-centered care, and health equity.
Several other comments requested that if HHS continues to allow specific sites to offer a single method of contraception, HHS must clarify that the method be medically approved and effective.
The Department received further comments regarding the language in the NPRM requiring sites that do not offer the broad range of methods and services to provide a referral, and the referral must not unduly limit the clients access to their method of choice. Many comments expressed support for requiring that sites refer clients if the site does not offer the clients method of choice. Some comments expressed concern that it was unclear what was meant by not unduly limit the clients access and how the requirement would be enforced across diverse communities.
Some comments expressed concern that rural communities with more limited access to refer clients to other organizations nearby would be penalized if the referral was considered to unduly limit the clients access. Some comments asserted that requiring referrals for a clients method of choice would result in faith-based and natural family planning providers leaving the Title X network. Several other comments expressed concern that the referral requirement was vague and
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