Federal Register - October 7, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations individuals receiving services must be held confidential and must not be disclosed without the individuals documented consent, except as may be necessary to provide services to the patient or as required by law, with appropriate safeguards for confidentiality. Otherwise, information may be disclosed only in summary, statistical, or other form which does not identify particular individuals.
Reasonable efforts to collect charges without jeopardizing client confidentiality must be made. Recipient must inform the client of any potential for disclosure of their confidential health information to policyholders where the policyholder is someone other than the client.
b To the extent practical, Title X
projects shall encourage family participation.12 However, Title X
projects may not require consent of parents or guardians for the provision of services to minors, nor can any Title X
project staff notify a parent or guardian before or after a minor has requested and/or received Title X family planning services.
This revised language for 59.10 is adopted as final.
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59.12
Other Applicable Regulations
In the NPRM, the Department included the same regulatory text as had been included in section 59.10 of the 2000 regulations, which is a list of additional HHS regulations that apply to the Title X family planning services program. The NPRM proposed a technical correction to update the list of applicable regulations by adding 45 CFR
part 87.
Comments: Many comments that generally support the rule disagree with the proposed technical correction to section 59.12, which includes a reference to 45 CFR part 87 Equal Treatment for Faith-based Organizations in the list of regulations that apply to the Title X program. Such comments argued that this rule does not apply to Title X because the previous administration explicitly declined to apply this rule to Title X in the faithbased organizations rule issued on December 17, 2020 see 85 FR 82037, 82117. Additionally, these comments argued that 45 CFR part 87 does not apply to the Title X program because it is a health services program, and 45 CFR
part 87 only applies to social services programs; thus, the reference to this regulation should be removed from 12 42 U.S.C. 300a states: To the extent practical, entities which receive grants or contracts under this subsection shall encourage family participation in projects assisted under this subsection.
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section 59.12 of the final rule. Other comments argued that, if the Department is planning to make technical corrections to update the list of regulations that apply to the Title X
program, it should take the opportunity to clarify the applicability of 45 CFR
part 92 Nondiscrimination on the Basis of Race, Color, National Origin, Sex, Age, or Disability in Health Programs or Activities Receiving Federal Financial Assistance and Programs or Activities Administered by the Department of Health and Human Services Under Title I of the Patient Protection and Affordable Care Act or by Entities Established Under Such Title as well as the statute under which it was authorized, section 1557 of the Affordable Care Act. These comments stipulated that if the Department makes changes to this regulation in the future, section 59.12
should be updated at that time to include 45 CFR part 92 on this list of applicable regulations.
Comments opposing the rule agreed with the inclusion of 45 CFR part 87 in section 59.12, but questioned why the Department did not include an explanation for deleting references to the now-superseded 45 CFR part 92
Uniform administrative requirements for grants and cooperative agreements to state and local governments. These comments also argued that the Department should include a reference to 45 CFR 88 Protecting Statutory Conscience Rights in Health Care;
Delegations of Authority on the list of applicable regulations, as it will apply to the Title X program once related litigation is resolved.
Response: The Department appreciates the comments addressing the proposed technical corrections to 45
CFR 59.12, but has decided to eliminate that section from the final rule in its entirety. Since the regulations that apply to the Title X program will apply of their own accord, whether or not they are cross-referenced in 42 CFR part 59, subpart A, the Department has concluded that the list of applicable regulations in 59.12 serves no useful purpose and, in contrast, may be misleading. The Department is concerned that since regulations are amended frequently, any current listing of applicable regulations could soon become outdated. Additionally, while all of the longstanding Departmental regulations, such as those prohibiting discrimination, still apply, the Department is concerned that the 59.12
list may provide a false impression that only the regulations included in this section apply to the Title X program.
The Department believes that Title X
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grantees can more accurately assess which regulations apply to the Title X
program by reviewing the regulations at issue and, in some instances, seeking guidance from the agencies which administer them. For example, several comments, in the context of addressing the confidentiality provisions, questioned the applicability of the information-blocking provisions in the 21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT Certification Program rule 85 FR 25642, May 1, 2020. As that rule is administered by the HHS Office of the National Coordinator for Health Information Technology ONC, ONC would be in the best position to interpret that rule.
Most importantly, OPA provides information to Title X grantees regarding which regulations apply to their Title X programs and is committed to providing ongoing guidance and assistance as questions arise. OPA
includes information about applicable regulations in grant documents, such as NOFOs and Notices of Award, and in technical assistance webinars. Given that grantees can receive accurate and up-to-date information from OPA about which regulations apply to their Title X
programs, the Department has decided to delete section 59.12 from the final rule.
III. Regulatory Impact Analysis A. Introduction The Department has examined the impact of the final rule under Executive Order 12866 on Regulatory Planning and Review, Executive Order 13563 on Improving Regulation and Regulatory Review, Executive Order 13132 on Federalism, the Regulatory Flexibility Act 5 U.S.C. 601612, and the Unfunded Mandates Reform Act of 1995
Pub. L. 1044. Executive Orders 12866
and 13563 direct the Department to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety, and other advantages;
distributive impacts; and equity. The Department believes that this final rule is not an economically significant regulatory action as defined by Executive Order 12866 because it will not result in annual effects in excess of $100 million.
The Regulatory Flexibility Act requires the Department to analyze regulatory options that would minimize any significant impact of a rule on small entities. The final rule will lessen
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