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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations
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H. 59.5a13. Subrecipient Monitoring I. 59.5b1 Provide Medical Services Related to Family Planning J. 59.5b3 Community Education, Participation, and Engagement K. 59.5b6 Services Under Direction of Clinical Services Provider L. 59.5b8 Coordination and Use of Referrals and Linkages M. 59.6 Suitability of Informational and Educational Material N. 59.7 Grant Review Criteria O. 59.10. Confidentiality P. 59.12 Other Applicable Regulations III. Regulatory Impact Analysis i. Introduction ii. 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 abortionrelated activities were permissible under the program, given Title Xs statutory prohibition on abortion services. That statutory prohibition, section 1008 42 U.S.C. 300a6, provides that none 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 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 prohibited Title Xfunded entities from referring for abortion, while requiring referral for prenatal care, regardless of a clients request, and 5 required providers to maintain detailed records on adolescent
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clients, including age of their sexual partners and specific actions taken to encourage family participation.
In the 2019 rule, the Department stated that it believes the provisions of this final rule provide much needed clarity regarding the Title X programs role as a family planning program that is statutorily forbidden from paying for abortion and funding programs/projects where abortion is a method of family planning. The Department believes that the 2000 regulations fostered an environment of ambiguity surrounding appropriate Title X activities. 84 FR at 7721 March 24, 2019. This belief about the ambiguity, however, lacked any specific evidence. OPA closely monitors Title X grantee compliance through regular grant reports, compliance monitoring visits, and legally required audits, and it has done so since the beginning of the program. Close oversight of Title X grantees for decades uncovered no misallocation of Title X
funds by grantees. OPA oversight did identify occasional instances where grantees were in need of updating their written policies to clearly reflect the Title X statutory language, but OPA
never found any instance where grantees were co-mingling funds with activities not allowed under the statute or regulations.
In response to concerns that the 2019
rule imposed undue and improper restrictions on grantees, the Department recently conducted a fresh review of the factual assertions that accompanied that rule. In particular, the Department carefully reviewed over 30 Government Accountability Office GAO, Office of the Inspector General OIG, and Congressional Research Service CRS
reports involving the Title X program from 1975 to 2021. Directly contradicting the factual assertions accompanying the 2019 rule, that recent review found only minor compliance issues with granteesand those only in two GAO reports from the 1980s. Those two reports recommended only more specific guidance, not a substantial reworking of the regulations. See, e.g., Comp. Gen. Rep. No GAO/HARDHRD
82106 1982, at 1415; 65 FR 41270, 41272 July 3, 2000. While those fortyyear-old reports found some confusion among grantees around section 1008, GAO found no evidence that Title X
funds had been used for abortions or to advise clients to have abortions. Since those reports, there has been no evidence of compliance issues regarding section 1008 by Title X grantees that would justify the greatly increased compliance costs for grantees and oversight costs for the federal government the 2019 rule required.

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Experience under the 2019 rule has only underscored these concerns. Based on that experiencewhich was not and could not have been available to the Department at the time the 2019 rule was promulgatedwe have determined that the 2019 rule has led to a diversion of funds from the core purpose of Title X: To provide a broad range of family planning services. Those funds are now being spent on increased infrastructure costs resulting from the separation requirement as well as the micro-level monitoring and reporting now required of grantees. None of these burdensome additional requirements provide discernible compliance benefits, particularly not to public health, and in some instances they are inconsistent with nationally recognized standards of care.
The significant negative public health consequences of the March 4, 2019 rule have become clear over the past two years, and the rule was extremely controversial from the beginning. The rule was immediately challenged in several district courts by 22 states and the District of Columbia, the American Medical Association, Title X grantee organizations, and individual grantees, with support from major medical organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the American Academy of Family Physicians, the Society for Adolescent Health and Medicine, and the Society for Maternal-Fetal Medicine.
The 2019 rule was ultimately upheld by an en banc Court of Appeals for the Ninth Circuit and enjoined only as to the state of Maryland by a district court in Maryland in a decision upheld by the en banc Court of Appeals for the Fourth Circuit. Both court of appeals decisions were issued over substantial dissents. In California v. Azar, 950 F.3d 1067 9th Cir. 2020, the Ninth Circuit relied heavily on Rust v. Sullivan, 500 U.S.
173 1991 in upholding the rule. A
majority of the en banc panel found, consistent with Rust, that the Department could interpret section 1008 as it did in the 2019 rule, and that nothing in subsequent legislation prevented this reading. Id. at 1085. The Ninth Circuit upheld the rule against an arbitrary and capricious challenge, stating that the new policy is permissible under the statute, that there are good reasons for it, and that the agency believes it to be better. Id. at 1097 emphasis in original. Conversely, a majority of the Fourth Circuit found the Departments 2019 rule arbitrary and capricious. Mayor of Baltimore v. Azar, 973 F.3d 258 4th Cir. 2020. The Fourth
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