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DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR …

This document is scheduled to be published in the Federal Register on 10/07/2021 and available online at , and on Billing Code 4150-30. DEPARTMENT OF HEALTH AND HUMAN SERVICES . 42 CFR Part 59. Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning SERVICES RIN 0937-AA11. AGENCY: Office of the Assistant Secretary for HEALTH , Office of the Secretary, DEPARTMENT of HEALTH and HUMAN SERVICES (HHS). ACTION: Final rule SUMMARY: The Office of Population Affairs (OPA) in the Office of the Assistant Secretary for HEALTH issues this final rule to revise the regulations that govern the Title X family planning program (authorized by Title X of the Public HEALTH Service Act) by readopting the 2000 regulations, with several revisions to ensure access to equitable, affordable, client-centered, quality family planning SERVICES for clients, especially low-income clients.

L. § 59.5(b)(8) Coordination and use of referrals and linkages M. § 59.6 Suitability of informational and educational material ... (42 U.S.C. 300a-6), provides that “[n]one of the funds appropriated under this title shall be used in programs where abortion is a method of family planning.” The 2000 regulations, which were in effect prior ...

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Transcription of DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR …

1 This document is scheduled to be published in the Federal Register on 10/07/2021 and available online at , and on Billing Code 4150-30. DEPARTMENT OF HEALTH AND HUMAN SERVICES . 42 CFR Part 59. Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning SERVICES RIN 0937-AA11. AGENCY: Office of the Assistant Secretary for HEALTH , Office of the Secretary, DEPARTMENT of HEALTH and HUMAN SERVICES (HHS). ACTION: Final rule SUMMARY: The Office of Population Affairs (OPA) in the Office of the Assistant Secretary for HEALTH issues this final rule to revise the regulations that govern the Title X family planning program (authorized by Title X of the Public HEALTH Service Act) by readopting the 2000 regulations, with several revisions to ensure access to equitable, affordable, client-centered, quality family planning SERVICES for clients, especially low-income clients.

2 The effect of this 2021 final rule is to revoke the requirements of the 2019 regulations, including removing restrictions on nondirective options counseling and referrals for abortion SERVICES and eliminating requirements for strict physical and financial separation between abortion-related activities and Title X project activities, thereby reversing the negative public HEALTH consequences of the 2019 regulations. OPA also makes several revisions to the 2000 regulations to increase access to equitable, affordable, client-centered, quality family planning SERVICES . DATES: This rule is effective [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE. FEDERAL REGISTER]. FOR FURTHER INFORMATION CONTACT: Jessica Swafford Marcella, Deputy Assistant Secretary for Population Affairs, Office of Population Affairs, Office of the Assistant Secretary for HEALTH , DEPARTMENT of HEALTH and HUMAN SERVICES , 200 Independence Avenue, Washington, DC.

3 20201; e-mail: SUPPLEMENTARY INFORMATION: As described in the 2021 Notice of Proposed Rulemaking (NPRM) (86 FR 19812, April 15, 2021), the DEPARTMENT proposed to revoke the 2019 Title X. regulations (84 FR 7714, March 4, 2019) and readopt the 2000 regulations (65 FR 41270, July 3, 2000). with 14 revisions and 10 technical corrections. Revisions were proposed to , (a)(1), (a)(3), (a)(8), (a)(9), (a)(12), (a)(13), (b)(1), (b)(3), (b)(8), , , , and Technical corrections were proposed to , (a)(4), (a)(5), (a)(6), (a)(7), (a)(11), (b)(3), (b)(2), , and HHS received comments on all of the revisions proposed in the NPRM, except the revision to In addition, the DEPARTMENT received comments on three of the 10 technical corrections, including the technical corrections to (a)(4), (a)(5), and Based on the comments received in response to the NPRM, the DEPARTMENT adopts eight of the revisions initially proposed in the NPRM and nine of the technical corrections initially proposed in the NPRM as final without additional changes.

4 This includes the revisions to (a)(3), (a)(8), (a)(9), (b)(3), (b)(8), , , and This also includes the technical corrections to , (a)(4), (a)(5), (a)(6), (a)(7), (a)(11), (b)(3), (b)(2), and Further, based on the comments received in response to the NPRM and a subsequent, new interpretation by the DEPARTMENT since the NPRM was issued, the final rule includes nine additional revisions and six additional technical corrections to what was proposed in the NPRM. The nine revisions include (a). additional modifications to four of the provisions initially revised in the NPRM ( , (a)(1), (b)(1), and ); (b) additional modifications to one of the provisions with a technical correction in the NPRM ( (a)(4)); (c) removal of three of the revised provisions in the NPRM ( (a)(12), (a)(13), and ); and (d) revisions to one provision not originally proposed for revision in the NPRM ( (b)(6)).

5 The six additional technical corrections include minor clarifications to , (a)(1), (a)(4), and and two technical corrections to (b)(7) and to reflect inclusive language. Detailed descriptions of all revisions, modifications, and technical corrections are included later in this final rule. In addition to revoking the 2019 rule, this final rule includes the following revisions to the 2000 rule: adding several new definitions; requiring sites that do not offer a broad range of contraceptive methods on-site to provide a prescription to the client for their method of choice or referrals, as requested; requiring that family planning SERVICES be client-centered, culturally and linguistically appropriate, inclusive, trauma-informed, and capable of ensuring equitable and quality service delivery; clarifying requirements around billing practices and income verification; enabling a broader range of clinical service providers to direct family planning SERVICES and to provide consultation for medical SERVICES related to family planning; clarifying the intent of community education.

6 Clarifying the purpose and responsibilities of the Information and Education Advisory Committee; including referral for primary healthcare providers; expanding the grant review criteria to address equity;. including language to safeguard client confidentiality; and removing the list of other applicable regulations from the regulatory text. The Secretary of the DEPARTMENT of HEALTH and HUMAN SERVICES (the Secretary) issues the below regulations establishing requirements for recipients of family planning SERVICES grants under section 1001 of the Public HEALTH Service (PHS) Act, 42 300. The rules below adopt, with the modifications described above, the regulations proposed for public comment on April 15, 2021 at 86 FR. 19812. They accordingly revoke the 2019 final rule, Compliance with Statutory Program Integrity Requirements, promulgated on March 4, 2019 (84 FR 7714).

7 Table of Contents I. Background II. Public Comment and Departmental Response i. General Comments Related to Revoking 2019 Regulations and Readopting the 2000. Regulations A. Compliance with Section 1008 (42 300a-6). B. Data on Negative Public HEALTH Consequences of 2019 Rule C. Grantee and Subrecipient Compliance D. Application of Conscience Statutes to Title X. E. Options Counseling F. Subrecipient Nondiscrimination G. Other Comments ii. Comments Regarding Proposed Revisions and Technical Corrections to the 2000. Regulation A. Definitions B. (a)(1). Broad range of acceptable and effective medically approved family planning methods and SERVICES . C. (a)(3). SERVICES are client-centered, culturally and linguistically appropriate, inclusive, and trauma-informed; protect the dignity of the individual;. and ensure equitable and quality service delivery consistent with nationally recognized standards of care.

8 D. (a)(4). SERVICES do not discriminate against any client based on religion, race, color, national origin, disability, age, sex, sexual orientation, gender identity, sex characteristics, number of pregnancies, or marital status. E. (a)(8). Charges for SERVICES with a schedule of discounts F. (a)(9). Reasonable measures to verify client income G. (a)(12). State reporting laws H. (a)(13). Subrecipient monitoring I. (b)(1) Provide medical SERVICES related to family planning J. (b)(3) Community education, participation, and engagement K. (b)(6) SERVICES under direction of clinical SERVICES provider L. (b)(8) Coordination and use of referrals and linkages M. Suitability of informational and educational material N. Grant Review Criteria O. Confidentiality P. Other applicable regulations III. Regulatory Impact Analysis i. Introduction ii.

9 Summary of Costs, Benefits, and Transfers iii. Comments on the Preliminary Economic Analysis and Our Responses iv. Summary of Changes v. Final Economic Analysis of Impacts IV. Environmental Impact V. Paperwork Reduction Act VI. 2021 Final Rule Regulatory Text I. Background As discussed in the NPRM (86 FR 19812, April 15, 2021), in 2019, the Secretary issued a final rule for the Title X program titled Compliance with Statutory Program Integrity Requirements, which substantially revised the longstanding polices and interpretations defining what abortion-related activities were permissible under the program, given Title X's statutory prohibition on abortion SERVICES . That statutory prohibition, section 1008 (42 300a-6), provides that [n]one of the funds appropriated under this title shall be used in programs where abortion is a method of family planning.

10 The 2000 regulations, which were in effect prior to the 2019 regulations and which reflected compliance standards that had been in effect for nearly the entirety of the Title X program, had been widely accepted by grantees, had enabled the Title X program to operate successfully, and had not resulted in any litigation. The rules issued on March 4, 2019 (84 FR 7714): (1) required strict physical and financial separation between abortion-related activities and Title X project activities, (2) required significant reporting by Title X grantees in grant applications and required reports about all subrecipients, referral agencies, or other partners who receive Title X funds, (3) removed the requirement for pregnancy options counseling upon request and permitted nondirective counseling only by an advanced practice provider, (4).


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