Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services, 56144-56180 [2021-21542]

Download as PDF 56144 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 59 RIN 0937–AA11 Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services (HHS). ACTION: Final rule. AGENCY: 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. 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 November 8, 2021. 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 SW, Washington, DC 20201; email: Jessica.marcella@hhs.gov. 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 59.2, 59.5(a)(1), 59.5(a)(3), 59.5(a)(8), 59.5(a)(9), 59.5(a)(12), 59.5(a)(13), 59.5(b)(1), 59.5(b)(3), 59.5(b)(8), 59.6, 59.7, 59.10, lotter on DSK11XQN23PROD with RULES3 SUMMARY: VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 and 59.11. Technical corrections were proposed to 59.2, 59.5(a)(4), 59.5(a)(5), 59.5(a)(6), 59.5(a)(7), 59.5(a)(11), 59.5(b)(3), 59.6(b)(2), 59.8, and 59.12. HHS received comments on all of the revisions proposed in the NPRM, except the revision to 59.11. In addition, the Department received comments on three of the 10 technical corrections, including the technical corrections to 59.5(a)(4), 59.5(a)(5), and 59.12. 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. This includes the revisions to 59.5(a)(3), 59.5(a)(8), 59.5(a)(9), 59.5(b)(3), 59.5(b)(8), 59.6, 59.7, and 59.11. This also includes the technical corrections to 59.2, 59.5(a)(4), 59.5(a)(5), 59.5(a)(6), 59.5(a)(7), 59.5(a)(11), 59.5(b)(3), 59.6(b)(2), and 59.8. 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 (59.2, 59.5(a)(1), 59.5(b)(1), and 59.10); (b) additional modifications to one of the provisions with a technical correction in the NPRM (59.5(a)(4)); (c) removal of three of the revised provisions in the NPRM (59.5(a)(12), 59.5(a)(13), and 59.12); and (d) revisions to one provision not originally proposed for revision in the NPRM (59.5(b)(6)). The six additional technical corrections include minor clarifications to 59.2, 59.5(a)(1), 59.5(a)(4), and 59.6 and two technical corrections to 59.5(b)(7) and 59.7 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, traumainformed, 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 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 planning services and to provide consultation for medical services related to family planning; clarifying the intent of community education; 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 U.S.C. 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). 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 U.S.C. 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. § 59.2. Definitions B. § 59.5(a)(1). Broad Range of Acceptable and Effective Medically Approved Family Planning Methods and Services C. § 59.5(a)(3). Services are ClientCentered, Culturally and Linguistically Appropriate, Inclusive, and TraumaInformed; Protect the Dignity of the Individual; and Ensure Equitable and Quality Service Delivery Consistent With Nationally Recognized Standards of Care D. § 59.5(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. § 59.5(a)(8). Charges for Services With a Schedule of Discounts F. § 59.5(a)(9). Reasonable Measures To Verify Client Income G. § 59.5(a)(12). State Reporting Laws E:\FR\FM\07OCR3.SGM 07OCR3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 H. § 59.5(a)(13). Subrecipient Monitoring I. § 59.5(b)(1) Provide Medical Services Related to Family Planning J. § 59.5(b)(3) Community Education, Participation, and Engagement K. § 59.5(b)(6) Services Under Direction of Clinical Services Provider L. § 59.5(b)(8) 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 X’s statutory prohibition on abortion services. That statutory prohibition, section 1008 (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 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 client’s request, and (5) required providers to maintain detailed records on adolescent VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 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 program’s 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 grantees—and 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/HARD–HRD– 82–106 (1982), at 14–15; 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. PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 56145 Experience under the 2019 rule has only underscored these concerns. Based on that experience—which was not and could not have been available to the Department at the time the 2019 rule was promulgated—we 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 Department’s 2019 rule arbitrary and capricious. Mayor of Baltimore v. Azar, 973 F.3d 258 (4th Cir. 2020). The Fourth E:\FR\FM\07OCR3.SGM 07OCR3 56146 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 Circuit also held that the 2019 rule violated an annual appropriations rider requiring nondirective counseling, the non-directive mandate.1 Losing parties in both cases sought review from the Supreme Court in October of 2020. The Court granted certiorari on February 22, 2021, consolidating the cases. No. 20–429. On March 12, 2021, the parties stipulated to dismiss the cases under Supreme Court Rule 46.1. While courts and judges were split on the ultimate legality of the 2019 rule, evidence of the negative public health consequences of the rule quickly became clear, and significant. After the implementation of the 2019 rule, 19 Title X grantees out of 90 total grantees withdrew from the program. The 19 grantees that withdrew from the Title X program included 11 State Departments of Health and independent Family Planning Associations and eight Planned Parenthood organizations.2 These organizations made clear to the Department in formal correspondence that they relinquished their grants out of concern that the 2019 rule interfered with the patient-provider relationship and compromised their ability to provide quality healthcare to all clients. One organization commented that ‘‘the Final Rule makes it impossible for us to provide healthcare and information to patients consistent with medical ethics and evidence-based standards of care.’’ Another organization stated that the 2019 rule ‘‘would fundamentally compromise the relationship our patients have with us as trusted providers of this most personal and private healthcare.’’ Another organization said that ‘‘the new regulations interfere with a healthcare provider’s ability to provide healthcare in accordance with accepted standards of care for reproductive health.’’ Still another said, ‘‘these new rules require our providers to deprive their patients of the information and services they 1 Both circuit courts also differed on the permissibility of the rule under section 1554 of the Affordable Care Act. 2 Withdrawn grantees included (1) Family Planning Association of Maine, Inc., (2) Hawaii Department of Health, (3) Health Imperatives, Inc. (MA), (4) Illinois Department of Health, (5) Maryland Department of Health, (6) Massachusetts Department of Public Health, (7) Oregon Health Authority, (8) Planned Parenthood Association of Utah, (9) Planned Parenthood Minnesota, North Dakota, South Dakota, (10 & 11) Planned Parenthood of Great Northwest & the Hawaiian Islands (two separate grants), (12) Planned Parenthood of Greater Ohio, (13) Planned Parenthood of Illinois, (14) Planned Parenthood of Northern New England, (15) Planned Parenthood of Southern New England, (16) Public Health Solutions (NY), (17) New York Department of Health, (18) Vermont Agency of Human Services, and (19) Washington State Department of Health. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 need to make and carry out fully informed decisions about their reproductive health. Our providers’ ethical and professional responsibilities do not allow this.’’ Although it might have been possible, at the time the 2019 rule was promulgated, to predict that providers would withdraw, any such prediction would have been uncertain. That so many providers did in fact withdraw from the program is a change in circumstances that, in the Department’s view, demands reconsideration of the 2019 rule. In addition to the grantees that withdrew from Title X completely, many other grantees that continued to receive Title X funding had subrecipients and service sites within their existing networks withdraw from the program. Overall, 19 grantees, including 231 subrecipients and 945 service sites, withdrew from the Title X program shortly after the rule took effect. Additionally, 18 grantees that continued in the program reported losses to their service network (i.e., exiting subrecipients) because of the 2019 final rule. As a result, the Title X program provided services to 844,083 fewer clients in 2019 compared to 2018.3 Comparing Family Planning Annual Report (FPAR) data for 2018 and 2019, OPA estimates that 94% (or 789,960) of the total decrease (844,083) in clients can be attributed to the 2019 rule. A total of 41 states and two territories saw a decrease in clients served in 2019 compared to 2018. Of those, seven saw a decline of more than 40 percent in clients served (AK, HI, MD, UT, VT, WI, and WV), seven saw a decline of 31–40 percent (CA, CT, ME, MN, NH, NM, and NY), seven saw a decline of 21–30 percent (AZ, IL, MA, MT, NJ, OR, and WA), seven saw a decline of 11–20 percent (IA, IN, MI, OH, PA, VA, and the Marshall Islands), nine saw a decline of 5–10 percent (AL, AR, KY, NE, NC, ND, SC, TN, and WY), and six saw a decline of five percent or less (DE, CO, LA, OK, SD, and the U.S. Virgin Islands). Only nine states, six territories and the District of Columbia saw their number of clients served stay the same (FL, KS, MO, RI, and TX) between 2018 and 2019 (±1%) or increase (GA, ID, MS, NV, six territories, and DC), with the majority experiencing a small annual increase of between 70 to 3,000 clients. Minor fluctuations notwithstanding, 789,960 fewer clients were served, which had a disproportionate impact on minority 3 (OPA, 2020). Family Planning Annual Report: 2019 National Summary Report. Accessed on March 9, 2021 from https://opa.hhs.gov/sites/default/files/ 2020-09/title-x-fpar-2019-national-summary.pdf. PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 clients, adolescent clients, lowerincome individuals, and those without insurance—all outcomes directly attributable to the 2019 rule. Most concerningly, there are six states that formerly had Title X services that currently have no Title X services available (HI, ME, OR, UT, VT, and WA) and seven states with Title X services available on a very limited basis (AK, CT, IL, MA, MN, NH, and NY). The Department believes that these stark facts, which became clear only after the promulgation of the 2019 rule, justify reconsideration of that rule. To ensure continuity of services and maintain a safe environment for clients and staff during the pandemic, Title X providers followed guidance issued by the Centers for Disease Control and Prevention (CDC), OPA, and others to manage supply and staffing shortages, and they implemented creative strategies tailored to their circumstances and clientele (virtual telehealth, for example). Despite these efforts, in 2020 vs. 2019, Title X had 193 fewer subrecipients (867 vs. 1,060) and 794 fewer service sites (3,031 vs. 3,825). The decrease in the size of the Title X service network appears to have substantially reduced the availability of and, consequently, access to Title X services. In 2020, Title X served 1.6 million fewer family planning users than in 2019 (1.5 million vs. 3.1 million), and Title X service sites delivered care to 302 fewer users per site (507 vs. 809). Furthermore, in 2020, Title X conducted almost 2.0 million fewer family planning encounters than in 2019 (2.7 million vs. 4.7 million). While the 2020 data undoubtedly reflect the public health emergency related to the COVID–19 pandemic, the pattern of the losses in the program initiated by the 2019 rule was exacerbated in 2020 for an already disrupted and weakened network. Of additional concern, the 2019 rule has had a disproportionate impact on low-income clients, who are precisely the population that the Title X program was established to serve. The 2019 rule has significantly decreased the number of low-income, uninsured, and racial and ethnic minorities accessing Title X services. Following implementation of the 2019 rule, 573,650 fewer clients under 100 percent of the federal poverty level (FPL); 139,801 fewer clients between 101 percent FPL to 150 percent FPL; 65,735 fewer clients between 151 percent FPL and 200 percent FPL; and 30,194 fewer clients between 201 percent FPL to 250 percent FPL received Title X services. This contradicts the purpose and intent of the Title X program, which is to prioritize and E:\FR\FM\07OCR3.SGM 07OCR3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 increase family planning services to low-income clients. Additionally, 324,776 fewer uninsured clients were served in 2019 compared to 2018. FPAR data also demonstrate that in 2019 compared to 2018, 128,882 fewer Black or African Americans; 50,039 fewer Asians; 6,724 fewer American Indians/ Alaska Natives; 7,218 fewer Native Hawaiians/Pacific Islanders; and 269,569 fewer Hispanics/Latinos received Title X services.4 Additionally, 151,375 fewer adolescent clients received essential family planning services in 2019. The Department believes these new facts warrant a reconsideration of the 2019 rule. The mandate of the Title X program is to support access to critical family planning and preventive health services; unfortunately, the result of the 2019 rule ran counter to that effort. The 2019 rule undermined the mission of the Title X program by helping fewer individuals in planning and spacing births, providing fewer preventive health services, and delivering fewer screenings for sexually transmitted infections (STIs). More specifically, in 2019 compared to 2018, 225,688 fewer clients received oral contraceptives; 49,803 fewer clients received hormonal implants; and 86,008 fewer clients received intrauterine devices (IUDs). Additionally, 90,386 and 188,920 fewer Papanicolaou (Pap) tests and clinical breast exams, respectively, were performed in 2019 compared to 2018. Confidential human immunodeficiency virus (HIV) tests decreased by 276,109. STI testing decreased by 256,523 for chlamydia, by 625,802 for gonorrhea, and by 77,524 for syphilis. Furthermore, 71,145 fewer individuals who were pregnant or sought pregnancy were served.5 In the 2019 rule, the Department stated that the rule was ‘‘expected to increase the number of entities interested in participating in Title X as grantees or subrecipient service providers and, thereby, to increase patient access to family planning services focused on optimal health outcomes for every Title X client.’’ 84 FR at 7782 (March 24, 2019). However, this expectation proved unwarranted. Despite several attempts, OPA has been unable to recruit new grantees and new providers into the Title X program to fill the current gaps in services resulting from implementation of the 2019 rule. 4 (OPA, 2020). Family Planning Annual Report: 2019 National Summary Report. Accessed on March 9, 2021 from https://opa.hhs.gov/sites/default/files/ 2020-09/title-x-fpar-2019-national-summary.pdf. 5 (OPA, 2020). Family Planning Annual Report: 2019 National Summary Report. Accessed on March 9, 2021 from https://opa.hhs.gov/sites/default/files/ 2020-09/title-x-fpar-2019-national-summary.pdf. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 First, OPA issued competitive supplemental funding of $33.7 million to 50 existing Title X grantees in fiscal year 2019 to expand their Title X services. Unfortunately, even with the additional funding, the majority of states were not able to increase the number of service sites in their Title X networks. From 2018 to 2020, 38 states and territories saw a decrease in the number of service sites in their networks, 12 saw no change in their number of service sites, and only nine saw an increase in the number of service sites. Analyzing users between 2018– 2020 for those nine states that gained service sites, six still lost users (WV, AZ, DE, NE, CO, and TX) while three gained users (GA, NV, and Palau). Next, OPA issued a competitive funding announcement in fiscal year 2020 to recruit new grantees to provide Title X services in unserved or underserved states and communities. The number of applications received was so low (eight eligible applications received) that the resulting grant awards were for less than the total amount of funding available (grant awards for $8.5 million with $20 million available), and OPA was only able to fund grantees to provide services in three states with no or limited Title X services at the time. The lack of organizations applying for Title X grant funding following implementation of the 2019 rule and the lack of new service sites willing to join existing Title X grantees as providers strongly suggest that the Department was wrong to believe that the 2019 rule would increase the number of grantees and providers. Rather, the 2019 rule appears to have had the opposite effect and resulted in a significant loss of grantees, subrecipients, and service sites, and close to one million fewer clients served from 2018 to 2019. The Department believes that this record warrants a change in course. The decline in clients served and services provided is devastating. The Title X program is the only federal grant program dedicated to providing comprehensive family planning and related preventive health services. Title X clinics provide services to clients, with priority given to persons from lowincome families. Title X services are voluntary, confidential, and provided regardless of one’s ability to pay. For many clients, Title X clinics are their only ongoing source of healthcare and health education. In fact, six in 10 women who go to a publicly funded PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 56147 family planning clinic consider it their usual source of medical care.6 While some family planning providers that withdrew from the Title X program were able to continue providing reproductive health services at some level in the absence of Title X funding, the services provided were not the same as those provided under Title X. Grantees that relinquished their Title X funding at the time made clear that they were not able to provide the same breadth of services as they had been able to under Title X and were not able to provide services using the same schedule of discounts as required in the Title X program. According to several comments received, the loss of Title X funding meant that organizations had to adjust their fee schedules and push more costs for services to the clients. As a result, organizations saw more clients forgoing recommended tests, lab work, STI testing, clinical breast exams, and pap tests. Further, due to costs, organizations saw some family planning clients outside of the Title X network choose less effective methods of birth control. The 2019 rule abandoned major portions of Providing Quality Family Planning Services: Recommendations from Centers for Disease Control and Prevention and the U.S. Office of Population Affairs (QFP),7 such as nondirective options counseling and referrals, and the client-centered approach recommended by QFP, over the objection of every major medical organization and without any countervailing public health rationale. QFP recommendations support providers in delivering quality family planning services and define family planning services within a broad context of preventive services, to improve health outcomes for individuals and their (future) children. QFP recommendations are based on a rigorous, systematic, and transparent review of the evidence and were developed with input from a broad range of clinical experts, OPA, and the CDC. These recommendations not only improve the quality of care provided to family planning clients, but they foster a supportive and communicative relationship between provider and patient. As evident from grantee relinquishment letters and comments 6 Frost, J., Gold., Hasstedt, K., & Sonfield, A. (2014). Moving Forward: Family Planning in the Era of Health Reform. New York: Guttmacher Institute. 7 CDC. (2014). Providing Quality Family Planning Services—Recommendations from CDC and the U.S. Office of Population Affairs. Accessed on March 8, 2021 from https://opa.hhs.gov/grantprograms/title-x-service-grants/about-title-x-servicegrants/quality-family-planning. E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 56148 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations received in response to the 2021 NPRM, abandoning major portions of this approach has damaged the patientprovider relationship. Moreover, the 2019 rule required prenatal referral even if the patient objected, an approach which also does not comport with wellaccepted public health and clinical care principles. On January 28, 2021, President Biden issued a ‘‘Memorandum on Protecting Women’s Health at Home and Abroad.’’ 8 The Memorandum stated that ‘‘[w]omen should have access to the healthcare they need. For too many women today, both at home and abroad, that is not possible. Undue restrictions on the use of Federal funds have made it harder for women to obtain necessary healthcare. The Federal Government must take action to ensure that women at home and around the world are able to access complete medical information, including with respect to their reproductive health.’’ The Memorandum then instructed the Department to ‘‘review the Title X Rule and any other regulations governing the Title X program that impose undue restrictions on the use of Federal funds or women’s access to complete medical information and shall consider, as soon as practicable, whether to suspend, revise, or rescind, or publish for notice and comment proposed rules suspending, revising, or rescinding, those regulations, consistent with applicable law, including the Administrative Procedure Act.’’ HHS reviewed the 2019 regulations pursuant to the President’s memorandum. Following this review, on April 15, 2021, the Department issued a Notice of Proposed Rulemaking (NPRM) for public comment (86 FR 19812, April 15, 2021), proposing rules to revise the 2019 regulation by essentially readopting the 2000 regulations. 65 FR 41270 (July 3, 2000). The 2000 regulations were consistent with applicable statutory commands, were widely accepted by grantees, enabled the Title X program to operate successfully, and led to no litigation over their permissibility. Based on the evidence that has emerged since the adoption of the 2019 rule, as well as a fresh consideration of the evidence that existed at the time, the negative public health consequences of the 2019 rule are clear. The rule dramatically reduced access to family planning and preventive health services that are essential for hundreds of 8 Available at https://www.whitehouse.gov/ briefing-room/presidential-actions/2021/01/28/ memorandum-on-protecting-womens-health-athome-and-abroad/. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 thousands of clients, especially for the low-income clients Title X was specifically created to serve. The 2019 rule decreased the number of providers willing to participate in the Title X program, further reducing access to family planning services within states across the country and in rural and urban communities alike. The 2019 rule shifted the Title X program 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. 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 and other disproportionately impacted communities, such as those in rural regions, minority clients, and adolescent clients, are relegated to inferior access. The populations served by Title X may already face health inequities driven by financial and access barriers to quality care that would be exacerbated by continuing to allow limited or delayed healthcare choices and biased or insufficient healthcare information. Given that so many individuals depend on the Title X program as their primary source of healthcare, the Department recognizes that this is a situation that must be rectified with urgency in the interest of public health and equity. Most importantly, in readopting the 2000 rule, this final rule removes the strict physical separation requirements that were imposed on top of existing obligations for separation between abortion services and Title X project related activities. It also allows Title X providers to provide truly nondirective counseling and refer their patients for all services desired by the client, including abortion services. The 2000 regulations successfully governed the Title X program for decades and were widely accepted by grantees. The 2019 rule imposed an interrelated set of requirements that are difficult to disentangle provision by provision. For example, 59.5(a)(5) prohibited funded projects from providing, promoting, referring, or supporting abortion as a method of family planning. Section 59.13 concurrently required assurance that a project did not ‘‘include abortion as a method of family planning’’ backed by documentary evidence of Subsections 59.14–59.16. The interrelatedness of these requirements PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 was underscored by 59.7(b) requiring applicants to ‘‘clearly address how the proposal will satisfy the requirements of the regulation,’’ before even proceeding to competitive consideration. Most of the 2019 provisions did not function independently of each other. The Department did initially propose keeping portions of two provisions from the 2019 rule regarding compliance reporting (59.5(a)(12)) on state sexual abuse notification laws and subrecipient monitoring (59.5(a)(13)). As further explained below, these provisions created administrative costs for grantees and the government with no measurable benefits. These provisions, like the entire 2019 rule, depended on assumptions about how the program should work and grantee compliance even with no evidence of grantee noncompliance. Given these considerations, the Department has determined that the most appropriate course is to revoke the 2019 rule in its totality. Every court to rule on the 2019 rule also believed that all of its provisions were of a piece and either struck down or upheld the rule in its entirety. See, e.g., Mayor of Baltimore v. Azar, 973 F3d 258, 292 (4th Cir. 2020) (‘‘Despite the severability clause, the Final Rule is not severable because it is clear HHS ‘intended the [Final Rule] to stand or fall as a whole,’ and the agency desired ‘a single, coherent policy, the predominant purpose of which’ is to reinstitute the 1988 Rule.’’). As compared to the 2019 rule, new provisions added to the re-adoption of the 2000 rule operate independently of each other—and the 2000 rule—to enhance the program. Particularly as the program operated for decades under the 2000 rule, the 2021 additions are severable from the 2000 rule. For example, while adding to the statutory goals of reaching low-income and underserved individuals, if the added grant evaluation criteria of equity, 59.7(a)(3), was excised, the program could still accomplish its mission successfully using the 2000 criteria alone. And, were a court to strike down the new income verification measures in 59.5(a)(9), the program would be able to accomplish its mission using the 2000 criteria alone. In addition to readopting the requirements as they existed prior to the 2019 rule, the 2021 rule also includes several revisions that will strengthen the Title X program and ensure access to equitable, affordable, client-centered, quality family planning services for all clients, especially for low-income clients, while retaining the longstanding prohibition on directly promoting or performing abortion that follows from E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations Section 1008’s text and subsequent appropriations enactments. Advancing equity for all, including people from low-income families, people of color, and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality, is a priority for the Department, for OPA, and for the Title X program. By focusing on advancing equity in the Title X program, we can create opportunities to support communities that have been historically underserved, which benefits everyone. The 2021 rule was written to ensure that the predominantly lowincome clients who rely on Title X services as their usual source of medical care have access to the same quality healthcare, including full medical information and referrals, that higherincome clients and clients with private insurance are able to access. Key strategies for advancing equity include removing barriers to accessing services, improving the quality of services, and providing services that are clientcentered. Several revisions in the rule focus on improving access to services. These revisions include clearly defining what constitutes a broad range of acceptable and effective family planning methods and services, requiring service sites not offering a broad range of methods on-site to provide a prescription to the client for their method of choice or referrals, as requested, clarifying required billing practices and income verification for low-income clients, enabling a broader range of clinical services providers to direct Title X services and to provide consultation for medical services, and strengthening client confidentiality. Several revisions in the 2021 rule focus on improving quality of Title X services. These revisions include clearly defining quality healthcare as safe, effective, client-centered, timely, efficient, and equitable; incorporating QFP’s definition of family planning into the regulation; and requiring all family planning services to be delivered consistent with nationally recognized standards of care. Finally, several revisions in the 2021 rule focus on ensuring client-centered care. These revisions include clearly defining clientcentered care as being respectful of, and responsive to, individual client preferences, needs, and values and where client values guide all clinical decisions, and requiring all family planning services to be client-centered, culturally and linguistically appropriate, inclusive, and traumainformed. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 II. Public Comment and Departmental Response The Department provided a 30-day public comment period for the proposed rule. That period closed on May 17, 2021. A total of 180,266 public comments were submitted to www.Regulations.gov or directly to the Department. With this 2021 final rule, the Department revokes the requirements of the 2019 regulations (84 FR 7714, March 24, 2019) and readopts the 2000 regulations (65 FR 41270, July 3, 2000) with several revisions. In the section below, the Department discusses the public comments, its responses, and the text of the final rules. The Department first presents a summary of public comments received related to revoking the 2019 regulation and readopting the 2000 regulation. The Department then provides a summary of comments received regarding the revisions and technical corrections proposed in the NPRM to specific provisions of the 2000 regulations. The NPRM proposed 14 revisions, including to 59.2, 59.5(a)(1), 59.5(a)(3), 59.5(a)(8), 59.5(a)(9), 59.5(a)(12), 59.5(a)(13), 59.5(b)(1), 59.5(b)(3), 59.5(b)(8), 59.6, 59.7, 59.10, and 59.11. The NPRM also proposed 10 technical corrections, including to 59.2, 59.5(a)(4), 59.5(a)(5), 59.5(a)(6), 59.5(a)(7), 59.5(a)(11), 59.5(b)(3), 59.6(b)(2), 59.8, and 59.12. The Department received comments on all the revisions proposed in the NPRM and three of the 10 technical corrections. The Department did not receive comments on the revision to 59.11, nor to the technical corrections to 59.2, 59.5(a)(6), 59.5(a)(7), 59.5(a)(11), 59.5(b)(2), 59.5(b)(3), or 59.8. A summary of comments and the Department’s response are only provided for those revisions and technical corrections that received comments. In addition, the Department received public comments requesting a revision to 59.5(b)(6) that was not proposed in the NPRM, but that is related to the revision that was proposed in the NPRM to 59.5(b)(1). A summary of these comments and the Department’s response are also included below. After considering the comments, the Department adopts the regulations proposed for public comment on April 15, 2021 at 86 FR 19812 with nine additional revisions and six additional technical corrections to what was proposed in the NPRM. PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 56149 General Comments Related To Revoking 2019 Regulations and Readopting the 2000 Regulations A. Compliance With Section 1008 (42 U.S.C. 300a–6) Comments: Thousands of comments expressed concern that the program’s returning to the 2000 regulations violated both the Title X statute and the Court’s holding in Rust v. Sullivan, 500 U.S. 173 (1991). Many comments stated referral for abortion ‘‘squarely’’ violated the ‘‘plain’’ ‘‘clear’’ text of section 1008. Many of these same comments also asserted the statute requires separation from abortion activities because they are programs ‘‘where’’ abortion is a method of family planning. Both comments believing the 2000 rule to be unlawful, and those affirming it to be lawful, cited Rust as well as legislative history in making their arguments. Those opposing the proposed rule also stressed that private organizations have no right to federal funding, much less to federal funding to perform abortions. These comments stated that ‘‘[m]oney is fungible,’’ and reverting to the 2000 rule will create so-called ‘‘slush funds’’ and infrastructure for organizations to perform abortions in violation of section 1008. They also suggested that the 2000 rule lacked any mechanism to ensure compliance with the statute, and that the NPRM, in fact, violates the statute because the proposed definition of ‘‘family planning’’ includes related ‘‘pregnancy counseling’’ which requires referral for abortion when requested (59.5(a)(5)). Many comments asserted that revoking the 2019 rule would allow grantees to engage in lobbying and other activities encouraging abortion that violate section 1008. Response: As stated in the NPRM, the Supreme Court held in Rust: ‘‘[W]e agree with every court to have addressed the issue that the language is ambiguous. The language of § 1008— that ‘none of the funds appropriated under this subchapter shall be used in programs where abortion is a method of family planning’—does not speak directly to the issues of counseling, referral, advocacy, or program integrity.’’ Rust at 184. No court adjudicating the 2019 rule found that the separation, referral, or other requirements were required by Rust. Such a finding would be contrary to the primary holding in Rust. Counseling for abortion, including referral when requested, has never been held to constitute a violation of section 1008. Interpreting section 1008 to prohibit referrals and require strict separation would also be inconsistent with nearly E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 56150 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations 40 years of agency practice under the program across numerous administrations. Such an interpretation would also appear contrary to decades of close Congressional oversight, including annual Title X appropriations riders, and a specific annual line item appropriation through which Congress can be—and has been—quite clear as to how the agency should operate. In readopting the 2000 rule, the program is also reinstating interpretations and policies under section 1008 of the statute that were in place for much of the program’s history and published in the Federal Register in 2000. 65 FR 41281 (July 3, 2000). Those program policies discuss, for example, the requirements for separation: ‘‘Separation of Title X from abortion activities does not require separate grantees or even a separate health facility, but separate bookkeeping entries alone will not satisfy the spirit of the law. Mere technical allocation of funds, attributing federal dollars to nonabortion activities, is not a legally supportable avoidance of section 1008.’’ 65 FR at 41282 (July 3, 2000). Also, ‘‘[w]hile a Title X project may provide a referral for abortion, which may include providing a patient with the name, address, telephone number, and other relevant factual information (such as whether the provider accepts Medicaid, charges, etc.) about an abortion provider, the project may not take further affirmative action (such as negotiating a fee reduction, making an appointment, providing transportation) to secure abortion services for the patient.’’ 65 FR at 41281 (July 3, 2000). Finally, while a Title X project may not advocate for abortion as a method of family planning, it ‘‘may be a dues paying participant in a national abortion advocacy organization, so long as there are other legitimate program-related reasons for the affiliation (such as access to certain information or data useful to the Title X project).’’ Id. Interested entities are encouraged to consult this notice. The Department agrees that it is not under a duty to subsidize abortion. It does not do so, and it is prohibited from doing so. As discussed in the NPRM, legislative history and longstanding appropriations riders prohibit Title X funds from being expended on abortion. See, e.g., Consolidated Appropriations Act, 2021, Public Law 116–260, Div. H, sec. 207, 134 Stat. 1182, 1590. More generally, Section 507 of the Consolidated Appropriations Act, 2021 prohibits federal funds from being used for abortion except for cases of rape, incest, or maternal health. Id. at sec. 507. As discussed in the NPRM and VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 above, the Department employs a variety of mechanisms to enforce such restrictions, such as regular grant reports, compliance monitoring visits, third-party audits, compliance guidance, and grantee education. None of these oversight tools have uncovered any more than minimal problems with grantee compliance under section 1008. The Department also agrees that no particular private organizations have a right to Title X funding. The program is returning to the program requirements in operation for the majority of its history because those requirements best serve individual clients and the public health. In the wake of the 2019 rule, both private organizations and states withdrew from the program, leaving multiple states without any Title X providers and the agency struggling to meet its mandate to provide family planning services for low-income populations in areas of high need. Though in some places organizations and jurisdictions were able to temporarily provide resources to replace the loss of Title X funds, providers were not always able to provide the same scope of services or seamless care coordination that Title X projects can provide. Public comments from those organizations made clear that they were not able to provide the same breadth of services, nor were they able to provide services with the same schedule of discounts for low-income clients. The Department disagrees that Title X grant funds allow for the ‘‘creation of slush funds’’ or that those funds are ‘‘fungible.’’ As stated above, the Department has multiple methods by which it confirms that grant funds are spent for grant purposes, and it has concluded that grantees comply, not just with section 1008, but with Congressional directives and other requirements of the program. Again, the 2019 rule could point to no significant compliance issues related to the diversion of Title X grant funds, and a fresh review of decades of evidence has uncovered no such issues. A ban on organizations receiving Title X funds for lawful activities outside of the Title X project would go beyond the 2019 rule and raise serious constitutional issues. And even if such a restriction might conceivably be lawful, the Department clearly has the discretion to open eligibility to the most qualified Title X providers.9 9 Zolna, M.R., & Frost, J.J. (2017, August 2). Publicly funded family planning clinics in 2015: Patterns and trends in service delivery practices and protocols. Guttmacher Institute. Retrieved from https://www.guttmacher.org/report/publiclyfunded-family-planning-clinic-survey-2015. PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 B. Data on Negative Public Health Consequences of 2019 Rule Comments: A few comments took issue with data presented in the NPRM. They stated that the Department used flawed data and failed to account for the effects of COVID–19, instead attributing the loss of grantees and subrecipients and the decline in services to the 2019 rule. One comment stated that the Department does not have data to assess the effect of the 2019 rule. Another comment argued that the decline in clients served is the result of a long time decline since the 2000 rule. One of those same comments reflected the belief that the decline in services is instead related to changes in insurance, changes in poverty, and use of the most effective contraceptive methods, and that declines have been continuous since 2000. Some of the comments also took issue with the Department’s position that the withdrawal of grantees from the program in response to the 2019 rule resulted in a decline in services, as they stated those services were continued with state and private funds and not discontinued, and the Department’s claims of fewer services provided is ‘‘a red herring.’’ The same comment pointed out the proposed rule noted that seven states saw an increase in clients after the 2019 rule. Another comment cited Planned Parenthood data showing that Planned Parenthood provided more services in 2020 compared to 2019 and that other providers stepped in to fill the gaps in services left when Planned Parenthood exited the Title X program. It cited Ohio as an example and said that additional clients would be served post-COVID–19. A final opposing comment claimed that the number of new providers applying for Title X funds increased after the publication of the 2019 rule. In contrast, numerous comments supported the 2021 NPRM and shared data on the negative impact that the 2019 rule has had in their states and communities, reinforcing the Department’s statements in the NPRM. Many of the comments spoke to the drastic reduction in clients they were able to serve after the 2019 regulation. One comment stated, ‘‘throughout the history of Title X, since its inception in 1970, there has never been as sharp a decline in the number of patients served by the program as occurred between 2018 and 2019.’’ More than losing numbers of clients, numerous comments spoke to the types of clients they have not been able to serve and the nature of services that are being lost because clients cannot afford those services. E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations Several comments noted that the 2019 regulation is disproportionately impacting rural regions, minority clients, adolescent clients, lowerincome individuals, and those without insurance, particularly in states that have not expanded Medicaid. Contrary to the comments that expressed Planned Parenthood affiliates were able to provide more services after leaving the Title X program, Planned Parenthood affiliates themselves, in addition to other commenters, indicated that without Title X funding, they have had to adjust their sliding fee scales, pushing more costs onto the clients. Comments stated that this has resulted in clients forgoing recommended tests, lab work, STI testing, clinical breast exams, and Pap tests in large numbers. Further, these comments provided evidence that some clients are choosing less effective methods of birth control due to costs. Other comments stated that the changes in fees have pushed their clients into seeking care elsewhere, interrupting their continuity of care. One comment reported that the loss of Title X funding resulted in loss of eligibility for the 340B Drug Pricing Program, requiring the agency to dispose of contraceptive methods purchased under the 340B Program and repurchasing them at higher market prices. The Attorneys General of 22 states and the District of Columbia commented that the emergency, one-time,10 and private funding made available to replace the loss of Title X funding has strained state budgets and could not be sustained, creating uncertainty for the future of their family planning providers. Additionally, several comments noted that the fundraising activities necessitated after leaving the Title X program have come at a cost and have resulted in providers having to scale back or eliminate educational and outreach programs in many states. Other comments noted that it was extremely burdensome to try to identify and recruit additional providers to fill the gaps left after the 2019 rule. Many commenters expressed strong interest in rejoining the Title X network once the current rule is replaced. Finally, several states reported that while their efforts were refocused on recruiting and onboarding new providers into their Title X network under the 2019 rule, they faced much resistance and/or a lack of interest, and their provider networks did not increase under this 10 States that provided emergency funding include CA, MA, MD, NY, OR, WA, and VT. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 rule, continuing to adversely impact the communities they serve. Response: The Department believes that the negative public health consequences of the 2019 rule are clear. The rule dramatically reduced access to essential family planning and related preventive health services for hundreds of thousands of clients, especially for the low-income clients Title X was specifically created 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 Department disagrees that the data cannot distinguish between enactment of the 2019 rule and the pandemic. The 2019 rule officially took effect mid-year in 2019, but COVID–19 was not announced as a national emergency until early 2020. The Department has data to assess the impact of the 2019 rule through FPAR and grantee progress reports, including data on the decrease in the number of clients served in 2019 when the rule was in place and prior to COVID–19. As stated in the Background section, 19 grantees, 231 subrecipients, and 945 service sites immediately withdrew from the Title X program. As a result, the Title X program provided services to 844,083 fewer clients in 2019 compared to 2018, prior to the implementation of the 2019 rule, approximately a 22 percent decrease. A total of 41 states and two territories saw a decrease in clients served in 2019 compared to 2018; five states saw their number of clients served stay the same; and four states, five territories, and the District of Columbia saw an increase in clients served from 2018 to 2019, with the majority experiencing a small annual increase of between 70 to 3,000 clients. Minor fluctuations notwithstanding, 844,083 fewer clients were served, disproportionately impacting lowerincome individuals, minority clients, adolescent clients, and those without insurance. There are currently six states with no Title X services available and seven states with Title X services available on a very limited basis. Ultimately, the hundreds of thousands of clients who lost access to Title X services as a result of the 2019 rule lost access to critical family planning and preventive health services. As noted in the background, this included declines in contraceptive services, Pap tests, clinical breast exams, and HIV and STI testing. The Department agrees that a few states were able to increase their service sites following the 2019 rule, but these PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 56151 are the exception. From 2018 to 2020, 34 states and territories saw a decrease in the number of service sites in their network, 18 saw no real change in their number of services sites, and only seven saw an increase in the number of service sites. OPA attempted to recruit new grantees to provide Title X services through a competitive funding opportunity, but OPA only received eight applications and was only able to provide services in three of the states with no or limited Title X services at the time. Some comments opposing the 2021 NPRM specifically cited Ohio as an example of a state that would be able to increase clients served post-COVID– 19. Despite the state health department receiving additional funds to provide Title X services following the departure of another grantee, FPAR data from Ohio, however, do not provide any clear support for this claim and reinforce that capacity among entities is not necessarily equivalent. According to the FPAR data from Ohio, the state experienced a 10 percent decline in service sites between 2018 and 2020, an 18 percent decline in clients from 2018 to 2019, and a 57 percent decline in clients from 2019 to 2020. While many states and territories experienced a decline in clients from 2019 to 2020 due to COVID–19, Ohio’s percentage decline in clients from 2019 to 2020 ranked 18th in order of states from largest decline to smallest decline. Seventeen states experienced a larger decline in clients from 2019 to 2020, and 41 states and territories experienced a smaller decline in clients. The data show that even if the same amount of funding is provided to a different set of grantees in a given area, it does not necessarily follow that the same number of clients will be served or same number of services will be provided, depending on the differences in grantee service capacity. Existing Title X grantees also experienced great difficulty recruiting new sites and new providers into their existing Title X networks under the 2019 regulations, as evidenced by the lack of states experiencing an increase in their number of service sites. Overall, it is clear that the 2019 rule directly resulted in a significant loss of grantees, subrecipients, and service sites, and close to one million fewer clients served from 2018 to 2019. While some states and organizations were able to provide family planning and related preventive health services in the absence of Title X funding, the comments made clear that they were not providing the full scope of services provided under the Title X program, they were not provided following the E:\FR\FM\07OCR3.SGM 07OCR3 56152 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 same standards as in Title X, and the same schedule of discounts and subsidies were not applied as required in the Title X program. Finally, many of the states that provided emergency or one-time funds, or those organizations that were able to raise funds privately, indicated through their comments that they could only do so on a very shortterm basis, that it was not sustainable for the long term, and that it came at a price—requiring elimination of other critical services. Given the data presented in the preamble and the data presented above, the Department disagrees with the claim that Title X services would improve after COVID–19 (absent a change in the 2019 rule). The loss in clients served, the states with no service providers, and the states with limited service providers occurred in 2019 after enactment of the 2019 rule and prior to COVID–19, making it unlikely that the number of clients served or services provided would increase to pre-2019 levels or above without a change to the 2019 rule. Comparing FPAR data for 2018 (‘‘typical year’’) and 2019 (post 2019 rule but preCOVID), OPA estimates that 94% (789,960) of the total decrease (844,083) in family planning clients between 2019 and 2020 can be attributed to the 2019 rule. Further comparing FPAR data for 2018 (‘‘typical year’’) and 2020 (postCOVID), OPA estimates that 63% (or 1.5 million) of the total decrease (2.4 million) in family planning users between 2018 and 2020 can be attributed to the final rule. The grantees and subrecipients that left the program have indicated that they will not return to the program under the 2019 rule. Coupled with the lack of additional applicants to the Department’s funding opportunity, the Department maintains the decline in access, clients, and services from 2018 levels will continue until a new rule is in place. C. Grantee and Subrecipient Compliance Comments: Several comments expressed concern that the 2021 NPRM did not include language from 59.1 in the 2019 rule, stating, ‘‘the requirements imposed by these regulations apply equally to grantees and subrecipients.’’ Several comments also expressed concern that the 2021 NPRM did not include language from 59.13 specifically requiring grantees to provide assurance that their project does not provide abortion and does not include abortion as a method of family planning. One comment stated that ‘‘[t]he removal of an explicit compliance requirement, without at minimum an explanation that subrecipients are assumed to have VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 to comply with all Title X regulations, suggests that such compliance is no longer required.’’ Another comment claimed that the departure of providers from the Title X network after the introduction of the 2019 rule confirmed that Title X funding had been used by those providers for impermissible purposes. Additionally, the comment claimed that the withdrawal demonstrates an unwillingness to comply with program requirements, and that ‘‘healthcare providers were accepting Title X funding for years without complying with the statutory requirements of the program.’’ Response: The Department disagrees with the comments and does not believe that it is necessary to include language within the Title X regulations stating that the regulations apply equally to grantees and subrecipients because this is already a requirement in the HHS grants regulations that apply to Title X grantees. All Title X grantees are subject to 45 CFR part 75, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards. In fact, Title X Notices of Funding Opportunity (NOFOs) state that successful applicants that accept an award agree that the award and all activities under the award are subject to all provisions of 45 CFR part 75. Specifically, 45 CFR 75.352 sets out the requirements for pass-through entities and clearly specifies that ‘‘all passthrough entities must (a) ensure that every subaward is clearly identified to the subrecipient as a subaward and includes the following information at the time of the subaward and if any of these data elements change, include the changes in subsequent subaward modification. . . . Required information includes . . . (2) All requirements imposed by the passthrough entity on the subrecipient so that the Federal award is used in accordance with Federal statutes, regulations and the terms and conditions of the Federal award.’’ Given that Title X grantees are required to follow 45 CFR part 75, and since 45 CFR part 75 makes clear that all requirements of the grant, including federal statutes, regulations, and terms and conditions of the federal award, apply to all subrecipients, the Department believes it is clear that the Title X regulations will continue to apply equally to all grantees and subrecipients without needing to include separate language in the Title X regulations. Similarly, the Department does not deem it necessary to include language within the regulation itself requiring PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 grantees to provide assurance that their project does not provide abortion and does not include abortion as a method of family planning. The Department has explicitly stated in all NOFOs that all grantees must comply with the Title X statute, regulations, and legislative mandates, and applicants certify in the application materials that they ‘‘[w]ill comply with all applicable requirements of all other Federal laws, executive orders, regulations, and policies governing this program.’’ Additionally, compliance with program statutes and appropriations act requirements is included as a standard term of the grant award. Therefore, during the application process, and by accepting funds, grantees have assured their compliance to the statute, regulations, and legislative mandates. The Department also disagrees with the contention that withdrawal of organizations following the 2019 rule proves that these organizations were non-compliant with the statutory requirements. The primary reasons cited by most grantees for withdrawing from the Title X program after promulgation of the 2019 rule was out of concern that the 2019 rule interfered with the patient-provider relationship and compromised their ability to provide quality healthcare to all clients. For certain grantees, the regulation was also in direct conflict with laws established by their state. Furthermore, there is no evidence to suggest that the grantees that withdrew from the Title X program had had any difficulties complying with the Title X statute, regulations, or legislative mandates. OPA practices, and practiced long before the 2019 rule, robust monitoring processes to ensure grantee compliance with the statute and regulations, including through regular grant reports, compliance monitoring visits, and legally required audits. As stated in the Background section, close oversight of Title X grantees for almost two decades under the 2000 rule uncovered no misallocation of Title X funds by grantees. OPA oversight did identify occasional instances over the years where grantees needed to update 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. The Department believes that grantee compliance with the Title X statute and regulations has not been an issue throughout the history of the Title X program, and the compliance monitoring methods that have historically been applied by OPA prior to the 2019 rule have ensured that E:\FR\FM\07OCR3.SGM 07OCR3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 grantees have an understanding of the statute and how to comply with it. The Department rejects as without merit the comments that these grantees were accepting Title X funding for years without complying with statutory requirements. Neither the 2019 rule itself nor any comments to the 2021 NPRM cited evidence of widespread noncompliance. D. Application of Conscience and Religious Freedom Statutes to Title X Comments: The Department received thousands of comments on the preamble language concerning the application of the conscience statutes to Title X. As further discussed in the NPRM, Congress has passed several laws protecting the conscience rights of providers, particularly in the area of abortion. For instance, under 42 U.S.C. 300a–7, the Church amendments, grantees may not require individual employees who have objections to abortion to provide such abortion counseling, or those who have objections to sterilization procedures to perform, assist in the performance of, or provide counseling regarding sterilizations. Since 2005, Congress has also annually enacted an appropriations rider, the Weldon amendment, which extends non-discrimination protections to other ‘‘health care entities’’ who refuse to counsel or refer for abortion. See, e.g., Consolidated Appropriations Act, 2021, Public Law 116–260, Div. H, section 507(d) (2020). Under these statutes, objecting providers or Title X grantees are not required to counsel or refer for abortions. Many commenters expressed a belief that the statutory conscience protections prohibited the agency from promulgating any counseling or referral requirements. Conversely, some asserted that the conscience statutes have no bearing on what requirements Title X could impose on grantees by regulation. Many comments asserted that these statutes had to be incorporated into the Title X regulatory text for them to be operative or the rule to be lawful. Some stated that the statutes themselves violated the separation between church and state. Several other comments cited a concern that applications from providers objecting to abortion counseling or referral would not be favorably evaluated. Many also suggested that the Department should simply allow for abortion counseling and referral rather than requiring it, since the conscience statutes protect objecting providers from those requirements in any case. Beyond the Church and Weldon Amendments, a few comments also VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 stated that requiring abortion counseling or referral automatically violated the Religious Freedom Restoration Act (RFRA), 42 U.S.C. 2000bb through 42 U.S.C. 2000bb–4. At least one comment suggested that the counseling and referral requirements coerced speech in violation of the First Amendment for those providers who object. Response: The conscience statutes have been the subject of multiple rulemakings and numerous lawsuits in the last 13 years. Most recently, the Department finalized a rule in 2019 providing definitions and an enforcement mechanism for several statutes protecting medical providers who have conscience-based objections to certain activities. Protecting Statutory Conscience Rights in Health Care; Delegations of Authority, 84 FR 23170 (May 21, 2019). That rule was vacated by three different courts. New York v. HHS, 414 F. Supp. 3d 475, 536 (S.D.N.Y. 2019) (appeal in abeyance); Washington v. Azar, 426 F. Supp. 3d 704, 722 (W.D. Wash. 2019) (same); City & Cty. of San Francisco v. Azar, 411 F. Supp. 3d 1001 (N.D. Cal. 2019) (same). While the statutes may at times interact with the requirements of Title X, interpreting these laws is beyond the scope of this rule and the HHS Office for Civil Rights (OCR) has been delegated authority to receive complaints under these provisions. Moreover, as the DC Circuit pointed out when the Weldon Amendment was enacted and the 2000 Title X rule was in effect, ‘‘a valid statute always prevails over a conflicting regulation,’’ Nat’l Family Planning & Reprod. Health Ass’n v. Gonzales, 468 F.3d 826 (D.C. Cir. 2006). This is true whether an overriding statute is incorporated into regulatory text or not. The applicability of other rules and laws are best evaluated by consulting those rules and laws and then seeking guidance from the agencies responsible for implementing them. Particularly in areas where the administrative rules may be modified or statutory directions may change from appropriation to appropriation, it is unwise for OPA to formalize interpretations beyond its own statutory authority. Irrespective of the points made above, as recounted in the NPRM, objecting individuals and grantees will not be required to counsel or refer for abortions in the Title X program in accordance with applicable federal law. OPA has long worked with grantees and providers to ensure appropriate compliance with conscience laws as well as continuity of care. As stated above, OCR has been delegated authority to receive any complaints PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 56153 related to the conscience protections and will continue to enforce them. As discussed in the NPRM, recognition of provider conscience rights has been the position of the Department since before the 2000 rule. See 65 FR at 41274 (2000 rule, stating that under ‘‘42 U.S.C. 300a– (d), ‘‘grantees may not require individual employees who have such objections to provide such counseling.’’). However, as also discussed in the 2000 final rule, the Secretary was unaware then—and is still unaware—‘‘of any current grantees that object to the requirement for nondirective options counseling.’’ Id. Just as non-objecting providers should not dictate the provision of information and referrals by those who do object, the existence of statutory conscience protections for providers does not preclude other willing providers from providing referrals or counseling for abortion within the program. With this final rule, the Department is emphasizing the importance of ensuring access to equitable, affordable, clientcentered, quality family planning services. Client-centered care is defined as being respectful of, and responsive to, individual client preferences, needs, and values, and ensures that the client’s values guide all clinical decisions. With an emphasis on providing services that are client-centered, the default should be the fullest provision of information to clients. Providers may avail themselves of existing conscience protections and file complaints with OCR, which will be evaluated on a case-by-case basis as is done with other complaints. As noted in previous iterations of both sets of rules, the conscience provisions and Title X rules have existed side by side for decades with very little conflict, or even interaction. From 1993 to 2017, Title X received no reports of grantees or individuals objecting to the regulatory requirement to counsel or refer for abortions when requested. See Nat’l Family Planning & Reprod. Health Ass’n, 468 F.3d at 830 (‘‘[T]here are structural reasons to doubt that the issue will ever come up. In 2000 HHS Secretary Shalala declined to create a specific exception from the pending [Title X] regulation’s mandatory referral requirement for organizations resisting provision of abortion counseling or referrals; she explained that she was ‘‘unaware of any current grantees that object to the requirement for nondirective options counseling, so this suggestion appears to be based on more of a hypothetical than an actual concern.’’). As with any issue facing Title X grantees and applicants, the program will work to provide guidance to grantees and coordinate any E:\FR\FM\07OCR3.SGM 07OCR3 56154 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations conflicts with the OCR. A case-by-case approach to investigations will best enable the Department to deal with any perceived conflicts within fact-specific situations. The Department declines to definitively interpret RFRA or the First Amendment in this context for largely the same reasons. Not only do the conscience protections more specifically allow providers to object to referral and counseling for abortion requirements, but the Title X rules in force for decades prior to the 2019 rule also existed side by side with RFRA and the First Amendment with no conflict. However, in light of the comments received, and to eliminate any confusion, the Department has noted in this final regulation that ‘‘[p]roviders may separately be covered by federal statutes protecting conscience and/or civil rights.’’ lotter on DSK11XQN23PROD with RULES3 E. Options Counseling Comments: The Department received thousands of comments expressing support for ‘‘the reinstatement of the requirement to offer nondirective options counseling to pregnant patients.’’ Many comments expressed support for reversing the 2019 rule’s restrictions on what referrals can be provided to clients and allowing providers to offer patients complete information about their healthcare options and refer patients to providers who offer services to meet those needs. One comment stated that ‘‘reinstating the 2000 regulations would remove this undue governmental interference into medical care and will help ensure patients receive medically accurate, comprehensive information from their physicians.’’ The Department also received comments in opposition to removing restrictions on referring for abortion services and requiring nondirective counseling. Several comments opposed removing restrictions on what referrals can be provided to clients in general, and a few opposed removing restrictions which state that only advanced practice providers can provide nondirective counseling. Many comments opposing the rule expressed a belief that the information and counseling requirements in this provision violate section 1008 of the Title X statute. Others believed that requiring ‘‘that grantees refer (sic) individuals to abortion providers conflicts with the free speech and religious freedom of grantees.’’ Still others expressed concern that the requirement could limit the type of providers in the program due to conscience concerns. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 Response: The Department appreciates the comments in support of this provision. The Department believes that offering pregnant clients the opportunity to receive neutral, factual information and nondirective counseling on all pregnancy options— and providing referral upon request for option(s) the client wishes to receive— are critical for the delivery of quality, client-centered care. The Department agrees that restoring this provision will remove unnecessary limitations governing the patient-provider relationship and will enable healthcare providers to offer complete and medically accurate information and counseling to their clients. The Department’s response to comments opposing this provision is included earlier in Section II. A. Compliance with Section 1008 (42 U.S.C. 300a–6) and D. Application of Conscience Statutes to Title X. The NPRM language for this provision would restore the regulatory text from the 2000 regulation, which successfully governed the Title X program for decades without opposition from major medical organizations and was widely accepted by grantees. F. Subrecipient Nondiscrimination Comments: The Department received many comments on state policies restricting subrecipient participation for reasons unrelated to the provider’s ability to provide care. The majority of these comments favored a regulatory prohibition on such restrictions because they often exclude the best family planning providers for no discernible purpose. Many comments stated that ‘‘State policies putting restrictions on how state funds are allocated, called ‘tiering,’ make it difficult or impossible for privately operated reproductive health-focused providers to receive funding. Tiering and other prohibitions against abortion providers often exclude the specialist providers that are the most qualified and best equipped to help Title X patients achieve their family planning goals.’’ Such restrictions, which are in place in approximately 15 states, can make access for certain subpopulations and geographic areas more difficult. Many comments stressed that ‘‘expelling well-qualified, trusted family planning providers from publicly funded health programs like Title X has adverse effects on patients’ access to critical family planning and sexual healthcare.’’ The Department also received many comments, including from multiple state Attorneys General, condemning any regulation in this area. Many of these objections stated that such a PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 regulation would undermine federalism and ‘‘intrude on the States’ selfgovernance for no good reason,’’ and, most prominently, violate the Congressional Review Act, 5 U.S.C. 801–808. Under that law, an agency may not promulgate a rule that is ‘‘substantially the same’’ as one that has been disapproved by Congress. In 2016, the Department enacted a rule barring projects from rejecting sub-grantees for non-programmatic reasons. 81 FR 91852 (Dec. 19, 2016). Congress subsequently revoked the rule. P.L. 115–23 (4/13/ 2017). Multiple comments asserted that any regulation in this area would be unlawful unless Congress specifically authorized it. Response: All proposed additions to the 2000 rule received an overwhelmingly positive response, except the proposal to include a subrecipient non-discrimination provision. After carefully considering several factors, the agency is declining to include a subrecipient nondiscrimination provision in this rulemaking. Foremost among the Department’s considerations is the sense of urgency in the interest of public health to complete this rulemaking. This schedule allows for a final rule to be effective before the award of the next round of competitive funding for the Title X program. This, in turn, will enable applicants that previously withdrew from participation in the program as a result of the previous regulation to apply for funding. The Department still believes state restrictions on subrecipients unrelated to care hamper the ability of the program to achieve its goals. However, the overriding task of this rulemaking is to undo the negative public health effects of the previous rule. That result is most effectively reached by not including a subrecipient nondiscrimination provision in this rulemaking. Organizations in states with restrictive laws may still apply directly to receive Title X grants (see PHS Act sec. 1001(b); 59.3). G. Other Comments Comments: While many comments were specific to certain sections of the proposed rule, a sizeable number were more general in nature, or commented on portions of the preamble. Many of these general comments were summarized in detail in the sections above, and the remainder of the general comments are summarized here. Of those that support the proposed rule, a large number of comments expressed general support for removing the harmful effects of the 2019 rule on Title X services. A similarly large E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 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 VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 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 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 56155 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 rule’s 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 E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 56156 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations including women whose employers do not cover contraception for religious reasons in the definition of low-income. One comment expressed support for the NPRM’s ‘‘returned focus on Title X’s priority population—low-income clients—and removal of the 2019 rule’s re-definition of ‘low income’ to use the program to pay for contraceptive services for any people whose employers refuse to include coverage for such services in their employer sponsored insurance due to religious or moral objections.’’ Several comments also expressed support for using more inclusive terminology throughout the NPRM and expressed that ‘‘‘client’ is more reflective of the diverse population of patients served by the Title X program.’’ Several comments, while supportive of the definitions included in the NPRM, did request specific revisions to many of the new or revised definitions. Several comments requested that the Department explicitly include systemic racism within the definition of health equity. Another comment requested that the Department revise the definition of health equity by expanding ‘‘the umbrella term ‘socially determined circumstances’ to ‘other circumstances that are socially, economically, demographically, or geographically determined.’ ’’ One comment requested that the Department revise the definition of adolescent-friendly services to include ‘‘developmentally appropriate services that support the healthy cognitive, physical, sexual, and psychosocial development of adolescents as they transition from childhood to adulthood and account for their unique needs, including with respect to confidentiality, legal status, and autonomy.’’ Other comments asked the Department to revise the definition of inclusivity to include non-religious people and the intersex community. One comment requested that the definition of trauma-informed care be revised to prevent future discrimination of transgender people by ‘‘clarifying that a trauma-informed program should not result in discrimination against any population.’’ The Department also received several comments opposing the new or revised definitions. A few comments opposed the definition of client-centered care and felt that it raised conscience concerns. Other comments opposed the definition of family planning services and specifically opposed removing abstinence and preconception health from the definition. One comment opposed the definition and said that ‘‘medically approved’’ did not include natural family planning. Another VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 comment questioned why the definition of family planning services did not emphasize ‘‘supporting unexpected pregnancies with assistance required by families and mothers—including emotional, educational, financial, and healthcare supports.’’ Other comments expressed general opposition to the definition of family planning services and felt that the definition included abortion and abortion-related services. One comment stated that the definition of health equity was vague and undermined the priority for serving low-income clients. Another comment stated that the focus on health equity was ‘‘targeting minority communities to restrict pregnancy,’’ and another stated that the focus on equity was unnecessary because of protections already included in the Constitution. One comment opposed the definition of cultural and linguistically appropriate services and expressed that ‘‘the phrase ‘culturally and linguistically appropriate services’ may bless health practices, based on cultural norms, that lead to negative health outcomes.’’ One comment opposed the definition of ‘‘trauma-informed’’ and said it was vague and that it was not clear what was required to be trauma-informed. One comment opposed the definition of inclusivity and felt that it would drive faith-based providers out of the program. Another comment took issue with the definition of ‘‘inclusivity’’ and stated that ‘‘segregation or prioritization of Title X services by protected classes such as race violates the Constitution and several civil rights laws.’’ A few comments opposed the use of the word ‘‘client’’ instead of ‘‘woman’’ throughout the NPRM and felt that the change in language was a disservice to women. Two comments opposed removing women who cannot receive contraception from their employer because they have a religious or moral objection from the definition of lowincome. A few comments opposed the definition of quality healthcare. One comment opposed including clientcentered and equitable within the definition of quality. Still another comment stressed that improving the quality of healthcare is a ‘‘dynamic process’’ and that ‘‘this dynamism requires a nimbleness often unattainable by national requirements.’’ The commenter requested that the definition of quality be amended to allow ‘‘maximum flexibility at the state and local level to establish standards of care.’’ Response: The Department appreciates the supportive comments regarding the new and revised definitions in the NPRM and believes PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 that clear definitions for terms used throughout the regulations are important for consistent implementation. The Department acknowledges comments requested revisions to many of the definitions; however, the Department believes that it is important to use widely accepted and commonly used definitions from other federal agencies and national medical organizations as the foundation for the regulation. For this reason, the Department will not revise the proposed definitions as requested by several comments. The Department disagrees that the definition of client-centered care raises conscience concerns. The purpose of the rule and the definitions is to refocus the program as a client-centered one, where well-being of the patient, not the provider, is the primary goal. As stated earlier, providers may avail themselves of existing conscience protections and file complaints with OCR, which will be evaluated on a case-by-case basis as is done with other complaints. The Department also disagrees with comments objecting to the definition of family planning services. The definition of family planning services within the NPRM is consistent with the definition of family planning services in QFP. Contrary to some of the comments opposed to the definition of family planning services, the definition does include preconception health, natural family planning, and abstinence (as a component of natural family planning). Family planning services include a broad range of services related to achieving pregnancy, preventing pregnancy, and assisting clients in achieving their desired number and spacing of children. Also, given that the focus of Title X is on helping clients achieve pregnancy, prevent pregnancy, and achieve their desired number and spacing of children, the Department responds to comments requesting that Title X provide support to clients once they become pregnant by noting that this is beyond the scope of the Title X program. Further, as is clear from section 1008 of the Title X statute, none of the funds appropriated for Title X are used in programs where abortion is a method of family planning. No court has found the decades-long practice of referral upon request to violate that prohibition. The Department disagrees with comments expressing concern with the definitions of health equity, cultural and linguistic appropriateness, inclusive, low-income, quality, and traumainformed. The definitions proposed in the NPRM are widely used definitions from other federal agencies and major E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 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 59.5(b)(1) and 59.5(b)(6) 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 OPA’s 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, VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 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. § 59.5(a)(1). Broad Range of Acceptable and Effective Medically Approved Family Planning Methods and Services In the NPRM, the Department proposed revising section 59.5(a)(1) 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 client’s method of choice. In addition, the NPRM specified that the referral must ‘‘not unduly limit the client’s 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 client’s method of choice and the referral must not unduly limit the client’s 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 59.5(a)(1), especially in support of the requirement that Title X projects provide a broad range of acceptable and effective medically approved family PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 56157 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 client’s access to their method of choice.’’ Many comments expressed support for requiring that sites refer clients if the site does not offer the client’s method of choice. Some comments expressed concern that it was unclear what was meant by ‘‘not unduly limit the client’s 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 client’s access. Some comments asserted that requiring referrals for a client’s 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 E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 56158 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations does not go far enough.’’ One comment asked the Department to ‘‘clearly outline the reasons and/or circumstances under which a Title X site may be excused from offering a broad range of medically approved methods and parameters, including a maximum ‘reasonable’ distance a Title X patient would have to travel to get their method of choice.’’ Another comment asked the Department to closely monitor the accessibility of referrals made by Title X sites. Other comments asked the Department to provide a specific number of minutes or miles from the Title X project to the referral location and to require that referrals be only to another Title X site to ensure the same discounted services would be available. Response: The Department appreciates the supportive comments for this provision in the 2021 rule. Since acceptable and effective medically approved family planning methods can change over time, the Department does not believe that additional specificity regarding what is meant by a broad range of methods and services is necessary within the regulatory text. Instead, the Department will provide additional guidance and technical assistance to assist grantees in complying with the regulation and ensuring access to a broad range of acceptable and effective methods and services across their service sites. The Department acknowledges the comments expressing concern with allowing an organization to participate in a Title X project if it only offers a single method of family planning as long as the overall project offers the broad range of methods and services. For much of the Title X program’s history, including in the 2000 regulations, the regulation has included this provision. The Department believes that retaining this provision in the 2021 rule is important to ensure flexibility in addressing community needs and recognizes that not all Title X service sites may be able to provide access to all methods and services. The Department will monitor and provide technical assistance to ensure that each grantee provides access to the broad range of acceptable and effective medically approved family planning methods and services to their clients. The Department disagrees that the referral requirement will result in faithbased and natural family planning providers leaving the Title X network. This is in part based on our longstanding experience with the program which for decades has included faith-based and natural family planning providers. The requirement for referral is intended to support VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 continuity of care for Title X clients. There are any number of opportunities by which this requirement could be fulfilled including directly by the clinic site or by the grantee in instances when a provider objects or lacks capacity to fulfill this requirement. An array of providers, including those that only offer a single method on-site, have successfully participated in the Title X program for decades. The Department will monitor and provide technical assistance to ensure that supporting client access to requested methods and services does not violate federal conscience laws. As part of the statutory mandate, Title X projects must provide natural family planning services, and the program will work with projects to ensure they provide all statutorily required services. Again, the Department is emphasizing in this final rule the importance of ensuring access to client-centered care. Client-centered care is defined as being respectful of, and responsive to, individual client preferences, needs, and values, and ensuring that client values guide all clinical decisions. With an emphasis on providing services that are clientcentered, the default should be the fullest provision of information and services to clients. The Department understands, based on the comments received, that it is challenging to include within the regulation a requirement that sites must provide a referral that does ‘‘not unduly limit the client’s access.’’ The Department fully recognizes that the referrals available to each Title X site will differ depending on what other referral resources are available within or near the community. Some communities may have access to a wide range of providers to refer clients to within the same community, while other sites may need to refer clients to organizations located farther away. Given the challenges in having one standard definition for what is considered undue burden across all Title X sites, the Department has decided to revise section 59.5(a)(1) to remove the requirement that ‘‘the referral must not unduly limit the client’s access to their method of choice.’’ In addition to the revision to remove this requirement, the final rule will also include one technical correction for this provision. The Department recognizes that if a Title X site does not have the client’s method of choice available onsite, the provider may be able to provide the client with a prescription for their method of choice, rather than having to provide a referral to another provider. To better account for this, the final provision will now require sites that are PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 unable to provide clients with access to a broad range of acceptable and effective medically approved family planning methods and services to provide a prescription to the client for their method of choice or referrals, as requested. As a point-of-entry to care, Title X sites often have robust referral networks with other safety-net agencies that are attuned to the needs of the client populations that they serve. While a prescription or referral does not guarantee a client the same schedule of discounts as at a Title X site, experience suggests that the family planning safety net recognizes and takes steps to limit accessibility burdens, including financial constraints, for the clients they serve. In addition, the Department will provide additional guidance and technical assistance to grantees to help them promote accessibility and limit patient burden. With the revisions noted above, the revised language for the 2021 rule for 59.5(a)(1) is, ‘‘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 prescription to the client for their method of choice or referrals, as requested.’’ This revised language is adopted as final. § 59.5(a)(3). Services are ClientCentered, Culturally and Linguistically Appropriate, Inclusive, and TraumaInformed; Protect the Dignity of the Individual; and Ensure Equitable and Quality Service Delivery Consistent With Nationally Recognized Standards of Care In the NPRM, the Department proposed revising section 59.5(a)(3) of the 2000 regulations. In addition to providing services that protect the dignity of the individual as required in the 2000 regulations, the NPRM stated, ‘‘Provide services in a manner that is client-centered, culturally and linguistically appropriate, inclusive, and trauma-informed; protects the E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations dignity of the individual; and ensures equitable and quality service delivery consistent with nationally recognized standards of care.’’ These revisions were aimed at increasing access and ensuring equity in all services provided, which the Department believes is especially important for the Title X program with a statutory priority on serving lowincome clients. In addition, the Department believes that the revisions will result in improved services for clients. Comments: The Department received numerous comments in support of this revised provision. Many comments expressed full support for the provision and urged the Department to adopt it as quickly as possible. Others expressed specific support for the requirement that services be client-centered: ‘‘We support that the proposed rule names the importance of using client-centered models of care.’’ Still others expressed specific support for the inclusion of QFP within the 2021 rule and the requirement that Title X services be consistent with nationally recognized standards of care. One comment said, ‘‘[T]he Proposed Rule will again base the standards of care for the Title X program on the QFP guidelines and require that Title X clients receive highquality, client-centered care that includes comprehensive, medically accurate counseling and information, and referrals for any other services sought.’’ The Department received a few comments opposed to this provision. One comment felt that requiring services to be client-centered, inclusive, and trauma-informed would create additional ‘‘burden on applicants and providers to ensure equity within their programs.’’ Another comment argued with the definition of client-centered care and believed that it violated conscience protections. Still another expressed concern that the requirement for equity in conjunction with the requirement for inclusivity would violate civil rights laws and the Constitution ‘‘by giving certain classes of people preferential treatment.’’ Response: The Department appreciates the comments in support of this provision and agrees that providing services in a manner required by this provision will advance equity, increase access, improve outcomes for Title X clients, and reinforce the longstanding requirement that ‘‘[s]ervices must be provided in a manner which protects the dignity of the individual.’’ The Department disagrees that the requirements of this provision will result in additional burden for applicants or providers, rather the VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 requirements of this provision simply ensure that all Title X services are of the highest quality and align with nationally recognized standards of care. The Department also disagrees that the requirements of this provision violate conscience protections and provides a specific response to comments concerning conscience earlier in Section II. D. Application of Conscience Statutes in Title X. Finally, the requirements of this provision do not give preferential treatment to any clients, but rather aim to ensure that all people can actively participate in and benefit from family planning services. In conclusion, the Department adopts the language from the NPRM for § 59.5(a)(3) as final without revisions. § 59.5(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 The NPRM proposed the same regulatory text for this provision as has been included in the 2000 regulations, which read ‘‘Provide services without regard of religion, race, color, national origin, disability, age, sex, number of pregnancies, or marital status.’’ Comments: The Department received several comments regarding this provision and specifically expressing concerns with the phrase ‘‘without regard of.’’ Several comments expressed concern with the specific phrase and stated that ‘‘if Title X providers are intended, as stated in the proposed rule, to work towards advancing health equity, it is imperative that care is delivered in a way that intentionally centers and considers the identity and needs of the patient.’’ Several comments requested that the Department revise the provision to instead say ‘‘provide services in a manner that does not discriminate against any patient based on religion, race, color, national origin, disability, age, sex, number of pregnancies, or marital status’’ which they felt better supports health equity. Response: The Department agrees with the comments and believes that revising the language as requested more clearly meets the intent of this provision, which is to prevent discrimination in the provision of services. In addition, the Department is updating ‘‘sex’’ in 59.5(a)(4) to include sexual orientation, gender identity, and sex characteristics consistent with the section 1557 of the Affordable Care Act, case law, Executive Order 13988 (86 FR 7023, Jan. 25, 2021), and Departmental PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 56159 policy (https://www.hhs.gov/about/ news/2021/05/10/hhs-announcesprohibition-sex-discrimination-includesdiscrimination-basis-sexual-orientationgender-identity.html). In Bostock v. Clayton County, 140 S. Ct. 1731 (2020), the U.S. Supreme Court held that Title VII of the Civil Rights Act of 1964 prohibition on employment discrimination based on sex encompasses discrimination based on sexual orientation and gender identity. Courts have now begun consistently interpreting similar language—‘because of sex’— in other statutes to encompass these protections. See Grimm v. Gloucester Cty. Sch. Bd., 972 F.3d 586, 616–617 (4th Cir 2020) (relying on Bostock to interpret Title IX as prohibiting policy prohibiting transgender student from using bathroom consistent with his gender identity). Moreover, as the Department of Justice has recently emphasized ‘‘Discrimination against intersex individuals is similarly motivated by perceived differences between an individual’s specific sex characteristics and their sex category (either as identified at birth or some subsequent time) . . . it is impossible to discuss intersex status without also referring to sex.’’ Title IX (justice.gov). As a result of the case law and Administration policy, the Department adds ‘‘sexual orientation’’, ‘‘gender identity’’, and ‘‘sex characteristics’’ to 59.5(a)(4).11 The revised language for the 2021 rule for 59.5(a)(4) is ‘‘Provide services in a manner that does 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.’’ This revised language is adopted as final. § 59.5(a)(8). Charges for Services With a Schedule of Discounts In the NPRM, the Department proposed revising section 59.5(a)(8) of the 2000 regulations by including widely accepted billing practices from the 2014 Title X Program Requirements. The NPRM text reads, ‘‘Provide that charges will be made for services to clients other than those from lowincome families in accordance with a schedule of discounts based on ability to pay, except that charges to persons from families whose annual income exceeds 250 percent of the levels set forth in the most recent Poverty Guidelines issued pursuant to 42 U.S.C. 11 This language reflects requirements on Title X projects principally engaged in healthcare activities under 42 CFR part 59. If grants for the production of informational materials were again to be made under PHSA § 1005, this definition might not apply. E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 56160 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations 9902(2) will be made in accordance with a schedule of fees designed to recover the reasonable cost of providing services. (i) Family income should be assessed before determining whether copayments or additional fees are charged. (ii) With regard to insured clients, clients whose family income is at or below 250 percent FPL should not pay more (in copayments or additional fees) than what they would otherwise pay when the schedule of discounts is applied.’’ Comments: The Department received several comments on this provision specifically seeking closer alignment of HRSA’s (Health Resources & Service Administration) Health Center Program (authorized by Section 330 of the PHS Act) and OPA’s Title X Program to minimize administrative burden for dually funded grantees. Specifically, one comment suggested modifying the proposed language in § 59.5(a)(8)(ii) to include additional language about sliding fee discounts from the Health Center Program Compliance Manual that states that sliding fee discounts are ‘‘subject to potential legal and contractual restrictions.’’ Another comment lauded § 59.5(a)(8)(ii) for ensuring that clients with family income at or below 250 percent FPL do not pay more than what they would otherwise pay under the schedule of discounts; however, the comment expressed that this ‘‘requirement violates insurance contracts and contradicts the guidance of other funders (e.g., HRSA).’’ Yet another comment expressed the need for additional guidance specific to Title X grantees and subrecipients operating under the Health Center Program, to assist with alignment of billing practices. Response: The Department fully supports minimizing administrative burden for grantees funded under both the Title X program and HRSA’s Section 330 Health Center Program, recognizing that providers that dually participate in the two programs have been one of the fastest growing segments of the Title X provider network. Similar to the Health Center Program’s statutory requirement that health centers must operate in a manner such that no patient shall be denied service due to an individual’s inability to pay, the Department also believes, and the Title X statute requires, that an individual’s ‘‘economic status shall not be a deterrent to participation’’ in Title X program services. See PHS Act sec. 1006(c). The Department does not believe that adding to this rule the commenter’s suggested language with respect to the Health Center Program Compliance Manual is warranted as it is taken out of context VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 and does not state the statutory requirement. The Department believes that adding language requested in the comments could hinder Title X clients who qualify for sliding fee discounts from receiving the discounts, which is contrary to Title X’s mandate of prioritizing services to low-income clients. Further, OPA clarifies how Title X grantees may remain in compliance with Title X Program requirements when integrating services with HRSA’s Health Center Program grantees and look-alikes in OPA Program Policy Notice: 2016–11: Integrating with Primary Care Providers.’’ Rather than revising the regulation and risk Title X clients not receiving all discounts for which they qualify, OPA will continue to work closely with HRSA to ease administrative burden for grantees funded under both programs. The Department will provide additional guidance and technical assistance to dually funded grantees aimed at reducing administrative burden. In conclusion, the Department adopts the language from the NPRM for § 59.5(a)(8) as final without revisions. § 59.5(a)(9). Reasonable Measures To Verify Client Income In the NPRM, the Department proposed adding a new section 59.5(a)(9) to include one requirement from the 2014 Title X Program Requirements that grantees take reasonable measures to verify client income, and a new requirement that grantees use client self-reported income if the income cannot be verified after reasonable attempts. The Department believes that these proposed revisions will greatly improve accessibility and affordability of services for low-income clients consistently across all Title X grantees. The NPRM text reads, ‘‘Take reasonable measures to verify client income, without burdening clients from low-income families. Recipients that have lawful access to other valid means of income verification because of the client’s participation in another program may use those data rather than re-verify income or rely solely on clients’ selfreport. If a client’s income cannot be verified after reasonable attempts to do so, charges are to be based on the client’s self-reported income.’’ Comments: The Department received several comments supporting the use of self-reported income. Comments received from members of the House of Representatives stated, ‘‘[W]e support the Department’s stance that patients be allowed to self-report their income, removing an unnecessary potential barrier to care.’’ Other comments PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 expressed support that ‘‘cost should not be a barrier’’ to receiving services. Still other reaffirmed support that allowing use of self-reported income ‘‘will greatly improve accessibility and affordability for low-income and uninsured patients seeking care from Title X program grantees.’’ One comment felt that the provision did not go far enough and asked that the language ‘‘explicitly state that a client’s self-reported income is sufficient, and that providers do not need to verify client income.’’ The Department also received several comments on this provision specifically seeking closer alignment between Title X and HRSA’s Health Center Program (authorized by Section 330 of the PHS Act) to minimize administrative burden for dually funded grantees. Several comments felt that allowing a client’s self-reported income in cases where a client’s income cannot be verified despite reasonable attempts is inconsistent with the Health Center Program guidance. Comments reported that ‘‘health centers have broad discretion to determine the appropriate means to assess patient income and family size. While allowing selfdeclaration is typical in the health center program, some health centers have opted to adopt a policy establishing that self-declaration, without supporting documentation, is not an acceptable means to verify income for every patient.’’ Response: The Department appreciates the supportive comments and agrees that the requirements in this provision will greatly improve accessibility and affordability of services for low-income clients consistently across all Title X grantees. The elimination of barriers to Title X services for low-income clients is important to the Title X program. The Department disagrees that the requirements in 59.5(a)(9) are not compatible with HRSA’s guidance. HRSA requires health centers to operate in a manner such that no patient shall be denied service due to an individual’s inability to pay; further, HRSA Health Center Program grantees are required to establish systems for sliding fee scale eligibility that comply with statutory requirements under section 330 of the PHS Act and regulatory requirements under 42 CFR 51c.303(f) and 56.303(f), which do not preclude self-declaration of income and family size. The Department believes that the HRSA Health Center Program requirements are fully consistent with the language in § 59.5(a)(9). A strict standard of income verification at a particular health center is a choice that does not warrant weakening a standard in Title X that the E:\FR\FM\07OCR3.SGM 07OCR3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 Department has created to support and reinforce the program’s statutory obligation to prioritize services to persons from low-income families. In conclusion, the Department adopts the language from the NPRM for § 59.5(a)(9) as final without revisions. § 59.5(a)(12). State Reporting Laws In the NPRM, the Department proposed adding 59.5(a)(12) to retain some, but not all, language from the 2019 rule on notification or reporting of child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence, or human trafficking. The NPRM language stated, ‘‘Title X projects shall comply with all State and local laws requiring notification or reporting of child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence or human trafficking (collectively, ‘‘State notification laws’’). Title X projects must provide appropriate documentation or other assurance satisfactory to the Secretary that it: (i) Has in place and implements a plan to comply with State notification laws. (ii) Provides timely and adequate annual training of all individuals (whether or not they are employees) serving clients for, or on behalf of, the project regarding State notification laws; policies and procedures of the Title X project and/or for providers with respect to notification and reporting of child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence and human trafficking; appropriate interventions, strategies, and referrals to improve the safety and current situation of the patient; and compliance with State notification laws.’’ Comments: Many comments supported the elimination of section 59.17 from the 2019 rule. Comments supported eliminating ‘‘the 2019 rule’s attempt to give HHS substantial oversight over compliance with complex state reporting requirements.’’ Many comments noted that ‘‘professionals providing services in Title X-funded sites are aware of their reporting obligations, already receive training on them, and make reports in compliance with these requirements.’’ Other comments stressed that determining compliance with state reporting laws lies with state authorities and noted that state reporting laws ‘‘are complex and vary widely from state to state.’’ One comment written in opposition to the NPRM expressed that the NPRM excluded ‘‘the mandatory reporting of sex trafficking and violence by intimate partners.’’ Another comment requested that the 2019 Title X requirement for mandatory reporting be kept fully intact. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 Another comment expressed concern that the proposed rule did not include the minor age record-keeping requirements and made an assertion that ‘‘[t]his lack of record keeping serves to enable sex traffickers and abusers to continue undetected in their abuse.’’ The comment proposed reinstatement of these requirements and further proposed rescinding the funding of any grant recipient who fails to screen for and report sexual abuse or sex trafficking. Response: The Department agrees with comments that all Title X recipients must follow state reporting laws and must comply with mandatory reporting requirements regarding child abuse, child molestation, sexual abuse, rape, or incest. The Department disagrees with the assertion that ‘‘. . . lack of record keeping serves to enable sex traffickers and abusers to continue undetected in their abuse.’’ States have already established specific guidelines on the details that must be included in mandatory reports. As such, the Department believes that it is not necessary to impose this additional reporting burden through Title X regulations. Since 1999, Congress has required, through the annual appropriations bill that, ‘‘[n]otwithstanding any other provision of law, no provider of services under Title X of the PHS Act shall be exempt from any State law requiring notification or the reporting of child abuse, child molestation, sexual abuse, rape, or incest.’’ All requirements in the appropriations riders are legislative mandates for the Title X program and all Title X grantees must comply with them. The Department will continue to enforce and monitor grantee compliance with all Title X statutory requirements and legislative mandates, including the mandate that ‘‘no provider of services under Title X of the PHS Act shall be exempt from any State law requiring notification or the reporting of child abuse, child molestation, sexual abuse, rape, or incest.’’ As noted above with respect to Section II. C. Grantee and Subrecipient Compliance, OPA explicitly states in NOFOs that all Title X grantees must comply with the Title X statute, regulations, and legislative mandates. In addition, Title X applicants certify in the application materials that they will comply with federal law, and compliance with federal law, and 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 PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 56161 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. OPA has consistently documented compliance with this mandated requirement and will continue to do so. A 2005 OIG report (OEI–02–03–00530) found that OPA has informed and periodically reminded Title X grantees of their responsibilities regarding state child-abuse and sexualabuse reporting requirements. Given the comments received and that Title X compliance with state mandatory reporting is already required through a legislative mandate for the Title X program, the Department does not deem it necessary to include this provision within the final regulation itself. Furthermore, this provision was a part of the 2019 rule that is being rescinded as a whole because it was a set of interrelated requirements that did not promote the public health or solve any Title X compliance concerns. In conclusion, the Department removes language from the NPRM for § 59.5(a)(12) from the 2021 final rule. § 59.5(a)(13). Subrecipient Monitoring In the NPRM, the Department proposed adding 59.5(a)(13) to retain some, but not all, of the language from the 2019 rule related to subrecipient monitoring and reporting. This addition required Title X grantees to report on the subrecipients and referral agencies involved in their Title X projects and to provide their plan for oversight and monitoring of their subrecipients in grantee reports. The NPRM language stated, ‘‘Ensure transparency in the delivery of services by reporting the following information in grant applications and all required reports: (i) Subrecipients and agencies or individuals providing referral services and the services to be provided; (ii) Description of the extent of the collaboration with subrecipients, referral agencies, and any individuals providing referral services, in order to demonstrate a seamless continuum of care for clients; and (iii) Explanation of how the recipient will ensure adequate oversight and accountability for quality and effectiveness of outcomes among subrecipients.’’ Comments: The Department received several comments expressing concerns with the requirements of this provision and the high reporting burden associated with it. One comment requested that section § 59.5(a)(13) be E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 56162 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations removed completely because of the additional reporting requirements it creates. Another comment requested that the Department only require grantees to submit the additional information required by this provision for subrecipients during regular reports but not during the initial application. The comment expressed a concern that for large Title X networks, ‘‘providing a description of all referral agencies and individuals, and outlining collaborations with each subrecipient, will still pose a significant burden for Title X grantees, particularly at the time of application when applicants are often afforded 60 days or less to apply.’’ Many other comments requested that the Department revise the language in this provision to focus only on subrecipients and not referral agencies ‘‘due to high burden’’ of reporting given the size of grantee networks and the high number of possible referrals made by individual sites. One comment stressed that ‘‘under the 2000 regulations, past grantees were required to monitor each organization and ensure that their clinic sites had appropriate referrals, that they were available to all clinic personnel, and that clients’ medical charts reflected appropriate referrals given and followup performed. However, grantees were not required to gather every referral source and report this information to HHS. This requirement will likely create an administrative burden that could be accomplished through HHS monitoring of grantees.’’ Response: It is clear from the comments received that the proposed requirements in § 59.5(a)(13) are unnecessarily burdensome for grantees and will result in Title X staff having to spend valuable time on administrative reporting that could otherwise be spent providing services to clients. The Department agrees that monitoring how grantees are involving and monitoring their subrecipients in their project and the composition of grantee referral networks can be achieved through the Department’s existing grantee compliance monitoring system. Departmental grants regulations at 45 CFR 75.352 already document the requirements for pass-through entities and specify the reporting required of grantees for all pass-through entities. Furthermore, this provision was a part of the 2019 rule that is being rescinded as a whole because it was a set of interrelated requirements that did not promote the public health or solve any Title X compliance concerns. Given the challenges noted with this provision and the additional reporting burden it would place on grantees, the VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 Department has decided to remove § 59.5(a)(13) from the 2021 final rule. § 59.5(b)(1) Provide Medical Services Related to Family Planning In the NPRM, the Department proposed revising section 59.5(b)(1) of the 2000 regulations to acknowledge that consultation for medical services related to family planning can be provided by healthcare providers beyond the physician. Specifically, the NPRM stated, ‘‘Provide for medical services related to family planning (including consultation by a healthcare provider, examination, prescription, and continuing supervision, laboratory examination, contraceptive supplies) and necessary referral to other medical facilities when medically indicated, and provide for the effective usage of contraceptive devices and practices.’’ The proposed revision acknowledged that consultation for healthcare services related to family planning may be by a physician, but may also be by other healthcare providers, specifically acknowledging participation by physician assistants and nurse practitioners. Comments: The Department received numerous comments supporting this revised provision, specifically in support of the recognition that a broad range of healthcare providers, in addition to physicians, have an important role to play in providing medical services related to family planning. Comments expressed agreement that ‘‘other clinicians often play an important role in providing family planning counseling and other services.’’ In addition, numerous comments asked the Department to clarify that this provision includes a broader range of healthcare providers beyond just physician assistants and nurse practitioners, as noted in the preamble of the NPRM. One comment asked that the Department use the definition of Clinical Services Provider from FPAR. Many other comments stated that ‘‘it is important to note that ‘consultation by a [healthcare] provider’ is not and should not be limited only to the examples cited by HHS, as these CSPs represent only one facet of healthcare providers in Title X settings.’’ In addition to the numerous comments related to the array of healthcare professionals that are responsible for clinical service provision in Title X, the Department also received numerous comments asking for the language of this provision to be revised to clearly reflect telehealth as an acceptable service delivery modality. Several comments expressed PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 the importance of telehealth, especially throughout the COVID–19 pandemic, in allowing many Title X clients to continue to safely access essential services. Many comments expressed concern with the Department’s use of the word ‘‘telemedicine’’ in the NPRM instead of ‘‘telehealth’’ and felt that telehealth refers ‘‘to a broader scope of remote healthcare services than telemedicine and includes non-clinical services like counseling and education.’’ Several comments specifically asked the Department to revise § 59.5(b)(1) to be clear within the regulation that family planning services can be provided ‘‘in person or via telehealth.’’ Other comments asked the Department to specify within the regulation that telehealth services can include ‘‘audioonly modalities’’ and expressed that ‘‘all forms of telehealth modalities, including audio-only must be covered to remove any barriers of access for patients.’’ One comment asked the Department to provide guidance to Title X grantees on how to use telehealth services to ensure access, equity, and quality. Response: The Department appreciates the comments in support of this provision, especially those that recognize the role of a broader range of healthcare providers in delivering family planning services. It was never the Department’s intention to imply that the only healthcare providers who could provide consultation under this provision were physician assistants and nurse practitioners. Physician assistants and nurse practitioners were included in the NPRM preamble to provide examples, but not to be exclusionary. The Department agrees with comments recommending use of the definition of Clinical Services Providers from FPAR to determine who is eligible as a healthcare provider under this provision and, as noted in the discussion related to Section 59.2 Definitions, is adding this definition to the final rule. The FPAR definition for Clinical Services Providers includes ‘‘physicians, physician assistants, nurse practitioners, certified nurse midwives, and registered nurses with an expanded scope of practice who are trained and permitted by state-specific regulations to perform all aspects of the user (male and female) physical assessments recommended for contraceptive, related preventive health, and basic infertility care.’’ The Department agrees with the comments reiterating the importance of telehealth and the role of telehealth services in expanding access to services and advancing equity. The Department had always intended for the final rule to apply to family planning services E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations provided in-person or via telehealth and had specifically stated in the NPRM that the Department was ‘‘readopting the 2000 regulations with revisions that will enhance the Title X program and its family planning services, including family planning services provided using telemedicine, for the future.’’ Telehealth has played a critical role for Title X in responding to the COVID–19 pandemic. By utilizing telehealth modalities, Title X grantees were able to continue to provide essential family planning services throughout the pandemic. With the onset of COVID–19, the vast majority of Title X grantees transitioned to some form of telehealth service delivery in order to continue providing services while limiting contact between individuals and protecting client safety. Telehealth was commonly used by Title X grantees for non-urgent visits that did not require a physical exam. Of importance, more than half of the grantees that were able to deliver telehealth during COVID–19 reported to OPA in their progress reports that they intended to continue offering telehealth services even after the pandemic ends, due to the advantages for both clients and staff. Given the comments received, the Department believes that it is important to include language specifically in the regulatory text to clarify that telehealth services also constitute appropriate service delivery. The Department also agrees with the request to use the term ‘‘telehealth’’ rather than ‘‘telemedicine’’ to be clear that telehealth services include non-clinical services like counseling and education. While cognizant that synchronous telehealth services may be delivered through different modes of technology and that audio-only modalities may mitigate access barriers, particularly for those with limited internet and/or cellular data, the Department does not agree that the regulatory text needs to be so specific to reference the use of ‘‘audioonly modalities,’’ especially given how rapidly technology can change. Instead, the Department will provide additional training and technical assistance to grantees on the use of various telehealth modalities to improve access, quality, and equity. With the revisions noted above, the revised language of 59.5(b)(1) for the 2021 rule is, ‘‘Provide for medical services related to family planning (including consultation by a clinical services provider, examination, prescription, and continuing supervision, laboratory examination, contraceptive supplies), in person or via telehealth, and necessary referral to other medical facilities when medically VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 56163 indicated, and provide for the effective usage of contraceptive devices and practices.’’ This revised language for § 59.5(b)(1) is adopted as final. respond to the comment received. In conclusion, the Department adopts the language from the NPRM for § 59.5(b)(3) as final without revisions. § 59.5(b)(3) Community Education, Participation, and Engagement In the NPRM, the Department proposed revising section 59.5(b)(3) of the 2000 regulations to reflect the desire to engage diverse individuals to make services accessible. Specifically, the NPRM stated, ‘‘Provide for opportunities for community education, participation, and engagement to: (i) Achieve community understanding of the objectives of the program; (ii) Inform the community of the availability of services; and (iii) Promote continued participation in the project by diverse persons to whom family planning services may be beneficial to ensure access to equitable, affordable, clientcentered, quality family planning services.’’ The revision added language to clarify the intent to engage diverse individuals to ensure access to equitable, affordable, client-centered, quality family planning services. Comments: The Department received one comment expressing support for 59.5(b)(3), especially emphasizing the importance of the participation and engagement of diverse individuals in making family planning services accessible, equitable, and clientcentered. The Department received one comment asking that the language of 59.5(b)(3) be revised to ‘‘be clear that the needs of adolescents and young adults’’ are included in community education, participation, and engagement. Response: The Department appreciates the comments in response to this provision. Community education, participation, and engagement are important for Title X projects because they help ensure that the community is aware of the Title X program and the services available. In addition, community participation and engagement are critical to helping Title X providers better understand and center the needs and experiences of the community and the clients served. Together, community education, participation, and engagement are foundational for ensuring access, equity, and quality through the provision of Title X services. In response to the one comment requesting a revision to the provision, the Department believes that the proposed regulatory text is broad and already includes the needs of adolescents and young adults as currently written. The Department does not believe that additional revisions are needed to the regulatory text in order to 59.5(b)(6) Services Under Direction of Clinical Services Provider The NPRM proposed the same regulatory text for this provision as has been included in the 2000 regulations, which read, ‘‘Provide that family planning medical services will be performed under the direction of a physician with special training or experience in family planning.’’ Comments: The Department received numerous comments requesting revisions to the regulatory text for this provision. Comments requested that the regulation expand beyond physicianonly directed services. Several comments requested that the text be revised to be consistent with the revisions to § 59.5(b)(1), which recognized the importance of a broader range of healthcare providers, in addition to physicians, in providing family planning services. Several comments requested revisions to expand direction of family planning services to very specific types of healthcare providers. One comment asked that the language clarify that nurse practitioners have the authority to direct family planning programs. Another comment asked that the language be revised from physician to ‘‘licensed healthcare provider.’’ Still another asked that this section be revised to specifically authorize physician assistants to direct family planning services. Several other comments were specific to advanced practice registered nurses (APRNs) and asked that the language specify that APRNs ‘‘be able to serve as the medical director (in states with full practice authority).’’ One commenter pointed out that ‘‘while state licensure rules vary, many states have granted full practice authority to APRNs, enabling independent practice.’’ Another comment requested that the Department consider whether registered nurses could direct family planning services ‘‘especially in areas of provider shortage.’’ A final comment asked for the text to be amended to allow services provided ‘‘under the direction of an advanced practice clinician, if the services offered are within their scope of practice and if allowable under state law.’’ Response: Given the comments received, the Department agrees that having consistency between 59.5(b)(1) and 59.5(b)(6) is important to more clearly reflect the role of a broader range of healthcare providers in providing PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 E:\FR\FM\07OCR3.SGM 07OCR3 56164 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 Title X services. The Department also agrees with comments that other healthcare providers, including physician assistants and APRNs in many states, have authority to direct family planning programs and should be included within the regulation. As stated earlier, the Department received comments in response to 59.5(b)(1) asking for more clarity on the term ‘‘healthcare providers’’ included in the NPRM, with many comments recommending use of the term ‘‘clinical services provider’’ as defined by OPA in FPAR. As a result, the Department has revised the final language for 59.5(b)(1) to use the term ‘‘clinical services provider’’ instead of ‘‘healthcare provider’’ and has revised 59.2 to include the FPAR definition of ‘‘clinical services provider’’ in the regulatory text. The FPAR definition for clinical services provider includes ‘‘physicians, physician assistants, nurse practitioners, certified nurse midwives, and registered nurses with an expanded scope of practice who are trained and permitted by state-specific regulations to perform all aspects of the user (male and female) physical assessments recommended for contraceptive, related preventive health, and basic infertility care.’’ To ensure consistency between 59.5(b)(1) and 59.5(b)(6) as requested in the public comments, the Department has revised the language for the 2021 rule for 59.5(b)(6) to, ‘‘Provide that family planning medical services will be performed under the direction of a clinical services provider, with services offered within their scope of practice and allowable under state law, and with special training or experience in family planning.’’ This revised language for § 59.5(b)(6) is adopted as final. 59.5(b)(8) Coordination and Use of Referrals and Linkages In the NPRM, the Department proposed revising section 59.5(b)(8) of the 2000 regulations to add language to include primary healthcare providers in the list of referrals and to state that referrals are to be to providers in close proximity to the Title X site when feasible. The NPRM stated, ‘‘Provide for coordination and use of referrals and linkages with primary healthcare providers, other providers of healthcare services, local health and welfare departments, hospitals, voluntary agencies, and health services projects supported by other federal programs who are in close physical proximity to the Title X site, when feasible, in order to promote access to services and provide a seamless continuum of care.’’ Comments: The Department received several comments expressing support VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 for revising the provision to include primary healthcare providers in the list of referrals and to require that referrals be to nearby providers, when feasible. One comment expressed support and said that ‘‘referring Title X patients to local primary care physicians would facilitate access to continuous, comprehensive healthcare.’’ Several other comments expressed support and stressed the existing collaborative relationships between many HRSAfunded health centers and Title X sites. Comments expressed that ‘‘referral relationships allow the health center and the Title X site to become more familiar with one another’s operations and service lines, often serving as a useful precursor to a more integral relationship in the future.’’ Response: The Department appreciates the many supportive comments in response to this revised provision. The Department agrees that it is important for Title X clinics to provide referrals and linkages to a wide range of healthcare services to help facilitate access for Title X clients to needed healthcare services beyond family planning. Given that the Department received no comments expressing concern with or opposition to the proposed modification, the Department adopts the language from the NPRM for § 59.5(b)(8) as final without revisions. § 59.6 Suitability of Informational and Educational Material In the NPRM, the Department proposed revising the 2000 regulations by combining requirements specific to the Information and Education Advisory Committee (‘‘Advisory Committee’’) that were in sections 59.5(a)(11) and 59.6 and consolidating all of the Advisory Committee information in one place, under section 59.6. The NPRM proposed several revisions to 59.6 to clarify that the regulation applies to both print and electronic materials (in both the title of the section and regulatory text), that the upper limit on council members should be determined by the grantee, that the factors to be considered for broad representation on the Advisory Committee match the definition of inclusivity earlier in the regulation, and that materials will be reviewed for medical accuracy, cultural and linguistic appropriateness, and inclusivity and to ensure they are trauma-informed. Specifically, the NPRM states: ‘‘(a) A grant under this section may be made only upon assurance satisfactory to the Secretary that the project shall provide for the review and approval of informational and educational materials PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 (print and electronic) developed or made available under the project by an Advisory Committee prior to their distribution, to assure that the materials are suitable for the population or community to which they are to be made available and the purposes of Title X of the Act. The project shall not disseminate any such materials which are not approved by the Advisory Committee. (b) The Advisory Committee referred to in paragraph (a) of this section shall be established as follows: (1) Size. The Committee shall consist of no fewer than five members and up to as many members as the recipient determines, except that this provision may be waived by the Secretary for good cause shown. (2) Composition. The Committee shall include individuals broadly representative of the population or community for which the materials are intended (in terms of demographic factors such as race, ethnicity, color, national origin, disability, sex, sexual orientation, gender identity, age, marital status, income, geography, and including but not limited to individuals who belong to underserved communities, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality). (3) Function. In reviewing materials, the Advisory Committee shall: (i) Consider the educational, cultural, and diverse backgrounds of individuals to whom the materials are addressed; (ii) Consider the standards of the population or community to be served with respect to such materials; (ii) Review the content of the material to assure that the information is factually correct, medically accurate, culturally and linguistically appropriate, inclusive, and traumainformed; (iii) Determine whether the material is suitable for the population or community to which is to be made available; and (iv) Establish a written record of its determinations.’’ Comments: The Department received one comment in support of the proposed revisions that expressed that ‘‘this will ensure that information and materials provided to clients are appropriate and suitable for the specific communities to be served.’’ Another E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations comment shared specific support for the requirement that grantees provide ‘‘culturally and linguistically appropriate’’ materials. One comment opposed to this provision expressed that the language in 59.6 ‘‘remains overly narrow and prescriptive’’ and recommended that the language be revised to require ‘‘a Community Advisory Board charged with a broad array of responsibilities to ensure the appropriateness of Title X services for intended communities.’’ Another comment opposed ‘‘underrepresented communities’’ in composition of the advisory council and claimed that ‘‘to the extent it results in segregation or prioritization of Title X services or committee membership by protected classes such as race, it violates the Constitution and several civil rights laws.’’ This same comment also opposed having the advisory committee review materials to certify that they are trauma-informed and inclusive. Response: The Department appreciates the supportive comment in response to this provision. The role of the Advisory Committee is critically important to ensure that the information and educational materials provided to Title X clients are factually correct, medically accurate, culturally and linguistically appropriate, inclusive, and trauma-informed. Engaging the community and population served in the Advisory Committee itself is a key strategy to inform the grantee about the needs and experiences of the community and population served, and to make sure that the information and education materials are appropriate for the community and population served. The Department disagrees with the comment that the language in 59.6 is too narrow and prescriptive. The Department believes that the requirements set forth in 59.6 are critical for ensuring that informational and educational materials provided to Title X clients are factually correct, medically accurate, culturally and linguistically appropriate, inclusive, and trauma-informed. In addition, the Title X statute prescribes requirements related to the informational and educational materials developed or made available under the project, including that they ‘‘will be suitable for the purposes of [Title X] and for the population or community to which they are to be made available, taking into account educational and cultural background of the individuals to whom such materials are addressed and the standards of such population or community with respect to such materials’’ (PHS Act sec. 1006(d)(1)), and also prescribes requirements related VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 to the Advisory Committee, including that the ‘‘committee shall include individuals broadly representative of the population or community to which the materials are to be made available’’ (PHS Act sec. 1006(d)(2)). The Department also disagrees with the comment that the regulation is segregating or prioritizing services or committee members. The text of the provision calls for the Committee membership to include ‘‘individuals broadly representative of the population or community for which the materials are intended. . . . Including but not limited to individuals who belong to underserved communities.’’ Since all communities served are different, the aim of this provision is to ensure the committee is representative of the community and population served, as required by the statute. The Department disagrees with the opposition to having the Advisory Committee review materials to ensure they are inclusive and trauma-informed. Providing information and educational materials that are inclusive and trauma-informed are a critical component of providing quality, client-centered care. The Department does not believe that revisions are needed to the regulatory text included in the NPRM. As a result, the Department adopts the language from the NPRM for § 59.6 as final with a technical correction to include ‘‘sex characteristics’’. § 59.7 Grant Review Criteria In the NPRM, the Department proposed revising section 59.7 of the 2000 regulations to add one additional review criterion that the Department may consider in deciding which family planning projects to fund and in what amount, which is ‘‘the ability of the applicant to advance health equity.’’ Adding this new criterion to the 2000 regulations brings the total number of grant review criteria specified in the regulation from seven to eight. Advancing health equity is critical to the mission of the Title X program. The addition of this grant review criterion will help ensure that grant funds are awarded to those applicants who are best able to help the Department in achieving the goal of advancing health equity through the Title X program. Comments: The Department received several comments in response to this revised provision asking for additional details in future funding opportunities about what the new criterion means and how it will be measured. One comment provided specific examples of how the Department could operationalize the new grant review criterion. Another comment asked the Department to PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 56165 ‘‘develop additional guidance and tools that Title X sites and other healthcare organizations can readily implement’’ to meaningfully advance health equity. Still another comment expressed concern that the NPRM did not include an explanation ‘‘for how a Title X project can, in fact, ensure equity in general and specifically in a way that does not lead to actual discrimination based on a protected basis.’’ Response: The Department appreciates the comments and recommendations received. The grant review criteria from the 2000 regulation include several criteria aimed at assessing the need, capacity, and ability of the applicant organization, including the relative need of the applicant, the capacity of the applicant to make rapid and effective use of the federal assistance, the adequacy of the applicant’s facilities and staff, the relative availability of non-federal resources within the community to be served and the degree to which those resources are committed to the project, and the degree to which the project plan adequately provides for the requirements set forth in these regulations. In addition, the grant review criteria from the 2000 regulation include two criteria aimed at assessing need in the communities served, including the number of clients, and, in particular, the number of low-income clients to be served; and the extent to which family planning services are needed locally. The Department believes that adding the new grant review criterion to assess the ability of the applicant to advance health equity is important to enable OPA to more fully assess the extent to which the applicant’s project will promote health equity through the Title X services provided. Under 59.2, health equity is defined as ‘‘when every person has the opportunity to attain their full health potential and no one is disadvantaged from achieving this potential because of social position or other socially determined circumstances.’’ Adding a focus on advancing health equity will not lead to discrimination or preferential treatment as expressed by some comments opposed to the NPRM. Rather, including a focus on advancing health equity aims to ensure that all people can actively participate in and benefit from family planning services. By advancing equity across the federal government, we can create opportunities for the improvement of communities that have been historically underserved, which benefits everyone. The federal government’s goal in advancing equity is to provide everyone E:\FR\FM\07OCR3.SGM 07OCR3 56166 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 with the opportunity to reach their full potential. To measure the ability of an applicant to advance health equity, OPA could assess how the location of planned Title X service sites compares to the need for family planning services within the communities served. OPA also could assess how the applicant plans to provide services in a manner that is culturally and linguistically appropriate. OPA could assess how the project plans to monitor outcomes by clients’ income, race, ethnicity, geographic location, etc., as well as how the project plans to address differences in outcomes through the Title X services provided. OPA could also ask applicants to describe the uptake of services by client demographics to identify existing disparities and to describe how they would work to reduce existing disparities in service provision. In addition, some agencies within the Department have incorporated disparity impact statements as a part of the post-grant award process. Disparity impact statements are just one example of a tool that OPA may consider in order to measure demographic, cultural, and linguistic data that identify the population(s) in which health disparities exist and the quality improvement plan designed to address the noted disparities. These are just examples of how this new grant review criterion could be operationalized within future NOFOs. The Department will provide details on how all grant review criteria will be measured in future NOFOs, including the new grant review criterion on advancing health equity. The Department also plans to develop training and technical assistance products to assist family planning providers in advancing health equity. In conclusion, the Department adopts the language from the NPRM for § 59.7 as final with one technical correction to replace ‘‘his estimate’’ with ‘‘an estimate’’ to reflect inclusive language. § 59.10. Confidentiality In the NPRM, the Department proposed revising the provision of the 2000 regulations related to confidentiality, which was section 59.11 in the 2000 regulations, but is now section 59.10, to add a widely accepted practice in the Title X community, indicating that reasonable efforts must be made to collect charges without jeopardizing client confidentiality. In addition, the Department proposed adding a requirement that grantees must inform the client of any potential for disclosure of their confidential health VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 information to policyholders where the policyholder is someone other than the client. Since state and local laws may vary across jurisdictions (e.g., some are likely to result in notification to the policyholder that the client has received services, others provide for an ‘‘opt out’’ process whereby the client can elect that such a notification will not be made), this addition was added to ensure that the client understands the implications for using their insurance and the options available for them to maintain confidentiality. Specifically, the NPRM stated, ‘‘All information as to personal facts and circumstances obtained by the project staff about individuals receiving services must be held confidential and must not be disclosed without the individual’s 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.’’ Comments: The Department received numerous comments in support of this provision and the proposed revisions. Many comments expressed support for restoring ‘‘the confidentiality protections that have been a hallmark of the Title X program.’’ Several comments expressed support for allowing ‘‘providers to return to the high standard of confidentiality that all patients, including adolescents, deserve when accessing healthcare services, especially ones as potentially sensitive as family planning and sexual health.’’ Several comments also specifically supported the new language on potential disclosure to policyholders. The Department also received numerous comments requesting further revisions to the regulatory text for 59.10. Numerous comments urged the Department to add language to the regulatory text to clarify that ‘‘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.’’ Comments underscored that this language has been longstanding guidance from OPA for the Title X PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 program and is included in OPA Program Policy Notice 2014–01: Confidential Services to Adolescents. One comment stated, ‘‘We encourage you to take all possible steps when finalizing the rule to ensure that adolescents are treated with the same client-centered approach as all other patients at Title X-funded health centers.’’ In addition, many comments generally opposed the removal of language from the regulation that encouraged family participation in the decision of a minor patient to seek family planning services and requested that the language be added back into the final regulation. Several other comments expressed concern with a new rule from the HHS Office of the National Coordinator for Health Information Technology (ONC) about Electronic Health Records and information blocking. Several comments requested that the Department confirm in the final rule that withholding of sensitive information in compliance with 59.10 would ‘‘fall within the ONC rule’s privacy exception and would not constitute information blocking.’’ Response: The Department appreciates the comments in support of the revised provision in the NPRM. The Department agrees with comments to add specific language to the final rule regarding adolescent confidentiality to reflect Title X legal requirements. Since 1981, the Title X statute has required that, ‘‘to the extent practical, [grantees] shall encourage family participation’’ in Title X projects. 42 U.S.C. 300(a). However, such involvement is not mandatory and grantees are required to protect clients’ confidentiality. Specifically with respect to adolescents, courts have for decades recognized minors’ rights to receive confidential services under the Title X program. See, e.g., Planned Parenthood Federation of America, Inc. v. Heckler, 712 F.2d 650 (D.C. Cir., 1983) (Title X expressly protects minors’ rights to seek services confidentially). See also OPA Program Policy Notice 2014–01: Confidential Services to Adolescents. The Department does not agree that specific language needs to be added to the final rule to clarify the applicability of the ONC rule to Title X. Instead, as described below related to section 59.12, OPA suggests that grantees seek guidance from ONC with respect to the applicability of the informationblocking provision, as ONC administers this rule and, thus, would be in the best position to interpret it. With this revision, the final language in the 2021 rule for 59.10 is, ‘‘(a) All information as to personal facts and circumstances obtained by the project staff about E:\FR\FM\07OCR3.SGM 07OCR3 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 individual’s 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. lotter on DSK11XQN23PROD with RULES3 § 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. 300(a) states: ‘‘To the extent practical, entities which receive grants or contracts under this subsection shall encourage family participation in projects assisted under this subsection.’’ VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 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 PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 56167 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. 601–612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4). 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 E:\FR\FM\07OCR3.SGM 07OCR3 56168 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 administrative burdens for grantees of all sizes. Therefore, the Secretary certifies that the final rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act, 5 U.S.C. 605. Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded Mandates Act) (2 U.S.C. 1532) requires the Department to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing ‘‘any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.’’ The current threshold after adjustment for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. This final rule will not result in an expenditure in any year that meets or exceeds this amount. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on state and local governments or has federalism implications. The final rule will not have a significant impact on state funds as, by law, project grants must be funded with at least 90 percent federal funds. 42 U.S.C. 300a–4(a). The Department has determined that this final rule does not impose such costs or have any federalism implications. The Department expects that while some states may not support the policies contained in this final rule, many states and local health departments will support the policies contained in this final rule, and that it will increase participation by states (many of which withdrew as a result of the 2019 rule). B. Summary of Costs, Benefits and Transfers This final rule will revise the regulations that govern the Title X family planning services program by revoking the 2019 rule and readopting the 2000 regulations with several modifications. This approach will allow the Title X program grantees, subrecipients, and service sites to have a greater impact on public health than under the current regulatory approach. We predict that this final rule will increase the number of grantees receiving Title X funds. In turn, the additional service sites supported by funding will result in additional clients served under the program. These clients receive access to contraception, and VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 public health screening including clinical breast exams, Papanicolau (Pap) testing, and testing for STIs. These services result in improved family planning and birth spacing, earlier detection of breast and cervical cancer, and earlier detection of sexually transmitted infections including chlamydia, gonorrhea, syphilis, and human immunodeficiency virus (HIV), all of which correlate to net savings for the government. This screening and testing can result in significant cost savings from earlier treatment and other interventions. This final rule will also increase the diversity of grantees receiving funds, including geographic diversity to states that do not currently have a Title X grantee. The final rule will also focus grantees on providing services in a manner that is client-centered, culturally and linguistically appropriate, inclusive, and trauma-informed; protects the dignity of the individual; and ensures equitable and quality service delivery. This focus is especially important for the Title X program that prioritizes services for low-income clients. This regulatory impact analysis reports the activity occurring at Title Xfunded sites to provide policymakers with this information. However, the direct impact within the program does not account for services that continue to be provided at sites not receiving Title X funding, filling the gap left by providers that withdrew from the program following the restrictions placed on funding included in the 2019 rule. C. Comments on the Preliminary Economic Analysis and Our Responses On April 15, 2021, the Department issued a proposed rule to revise regulations relating to the Title X program. The Department prepared a preliminary regulatory impact analysis (PRIA) for the proposed rule. Many comments were outside the scope of this rule. The paragraphs below describe and respond to the comments received on the PRIA. Summary of comments addressing the PRIA that were generally opposed to the rulemaking: Several of the comments suggested that the Department used flawed data in its forecasts or failed to account for COVID–19 in the PRIA. Several of the comments suggested that the Department does not have data to assess the effect of the 2019 rule, arguing that COVID–19 is a complicating factor. Several comments noted that clients served under the Title X program declined between 2009 and 2018, suggesting long-term trends can account PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 for some of the reduction in clients served under the 2019 rule. Other comments noted that long-term demographics trends are responsible for the decline in services, such as rise in median household income, rise in individuals with private insurance, and more diverse options available in the healthcare market. Several of the comments suggested that grantees withdrawing from the program may not have resulted in a decline in services, and that some services were continued with state and private funds. Several comments pointed out that some states saw an increase in clients after the 2019 rule. One comment argued that, when one of two Ohio grantees left the program, the remaining grantee prevented a gap in coverage. Responses to comments addressing the PRIA that were generally opposed to the rulemaking: The primary estimate of the baseline Title X service grantees, subrecipients, service sites, and clients served are derived from calendar year 2019 figures, which predate COVID–19. The PRIA’s estimate of the likely effect of the proposed rule is to gradually return to the level of grantees, subrecipients, service sites, and clients that the program supported in calendar years 2016 to 2018, which also predates COVID–19. COVID–19 may complicate attempts to precisely estimate the magnitude of the effect of the 2019 rule on the Title X program, but prepandemic data from calendar year 2019 preceding COVID–19 reveals a significant drop-off in grantees, subrecipients, service sites, and clients supported by the program, which are contrary to the predictions in the 2019 rule.13 The Department acknowledges the uncertainty in the forecast of the baseline scenario of no regulatory action by including a sensitivity analysis in the PRIA. The upper-bound forecast of 3,095,666 clients served annually by the Title X program under the baseline scenario of the 2019 rule is well below the approximately 4 million clients served during calendar years 2016 to 2018. The Department disagrees with the suggestion that long-term trends drove the reduction in clients served under the 2019 rule. Between calendar years 13 If adjustment to the requirements of the 2019 rule took time for grantees and prospective new grantees (and possibly continues to do so), then immediate post-issuance difficulties in obligating Title X funds could ease over the years, which would in turn lead to a trend back toward pre-2019 Title X service levels even in the analytic baseline. However, the effects of the COVID–19 pandemic would obscure, in the available data, whether such trends are present or absent. E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations 2009 and 2014, the number of clients reported served by the Title X program declined from 5.2 million to 4.1 million, with an average annual decline in clients served by about 211 thousand per year. Between calendar years 2014 and 2018, the number of clients served fell more gradually, with an average annual decline in clients served of about 48 thousand per year. In calendar year 2019, the number of clients served fell by about 844 thousand. The Department believes it is appropriate to attribute the bulk of the reduction in clients served during calendar year 2019 to the 2019 rule. The Department agrees with the comments that state and private funding likely averted some of the public health consequences that would have otherwise occurred in the immediate time period following implementation of the 2019 rule. The Department acknowledged this limitation in the PRIA and noted that one effect of the proposed rule would be ‘‘transfers (for example, if Title X newly funds medical services that would, in the absence of the proposed rule, be provided by charitable organizations or other private payers).’’ The Department noted that several states contributed emergency or one-time funds. It is not clear whether state or private funding will be available for the full-time horizon of the analysis, which begins in calendar year 2022. While the PRIA reported that ‘‘seven states (CO, DE, KY, ND, NM, NV, TX) experienced an increase in the number of Title X clinics after the 2019 regulatory change,’’ this observation is different than the claim about increases in clients. Colorado, Delaware, Kentucky, North Dakota, New Mexico, and Texas all saw declines in the number of female users served in 2019 and 2020 compared to 2018 (male users saw declines as well). Nevada increased the number of female users from 9,236 in 2018 to 11,156 in 2019, and again to 11,190 in 2020. The specific claim about Ohio cannot be supported with the available data. Ohio Title X grant recipients reported 83,497 female clients served in 2018, dropping to 68,669 in 2019, and dropping further still to 27,322 in 2020. Similarly, given the implementation of the 2019 rule occurred midway through the calendar year, the 2019 data likely mask the full negative impact of the 2019 rule that year. Summary of comments addressing the PRIA that were generally supportive of the rulemaking: Several comments agreed with the observation in the PRIA that the 2019 rule resulted in a reduction in grantees and clients served under the Title X VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 program. Several comments gave examples of states or other entities that saw a decrease in clients served. Several comments discussed the disproportionate impact the 2019 rule had on low-income individuals, individuals in rural communities, people of color, and other populations. Several comments discussed the impact of the 2019 rule on the quality of family planning services outside the Title X program, as well as the financial impact on clients receiving services outside the Title X program. Several comments argued that other sources of funding besides the Title X program, including state funding, would not be reliable sources of funding in the future. Responses to comments addressing the PRIA that were generally supportive of the rulemaking: The Department appreciates the specific examples provided in comments and agrees with the assessment that the 2019 rule resulted in a reduction in grantees and clients served at the national level, and that these effects were more pronounced in certain regions, communities, and demographic groups. The PRIA concluded, and this regulatory impact analysis affirms, that this rulemaking will likely result in an increase in clients served within the Title X program compared to a baseline of no further regulatory action. The Department also maintains the finding in the Further Discussion of Distributional Effects Section in the PRIA in this analysis that the effects of this final rule will accrue approximately in proportion with income and race and ethnicity figures typically served by the Title X program. The Department agrees that services provided outside the Title X program were not always identical to Title Xfunded services. While some providers were able to provide reproductive health services in the absence of Title X funding, comments disclose that they were not providing the same services provided in Title X program. Specifically, commenters suggested that services provided outside of the Title X program did not follow the same standards as in Title X, and that the schedule of discounts and subsidies were not applied as required in the Title X program. The Department agrees with the comments that other sources of funding besides the Title X program may not be reliable sources of funding over calendar years 2022 through 2026, the time horizon of the PRIA and this final regulatory impact analysis. The Department has expanded the discussion of this point in the analysis. PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 56169 Comments Received in Response to Executive Order 13132 Federalism Review Comment: Several comments were critical of the Regulatory Impact Analysis, stating that it ignores the federalism implications of the proposed rule. These comments argued that the proposed rule compels states to adopt policies that conflict with their own laws, particularly with regard to subrecipient restrictions that several states have put in place, and other statedescribed ‘‘integrity requirements.’’ Additionally, several comments raised concerns that the Department did not extend the comment period to specifically study the federalism impacts. Other comments expressed a belief that the proposed rule would have no federalism effects as it is a discretionary grant program in which states can choose to participate or not. Response: While the Department agrees that states have an interest in enforcement of their statutes, it believes that this final rule respects federalism, as it does not interfere with state laws. As noted previously, the Department has decided not to include a subrecipient nondiscrimination provision in the final rule at this time and, thus, concerns raised by these comments about harm to state program integrity requirements or a need to extend the deadline to assess the impact of this harm are now moot. Additionally, while states are eligible to apply for Title X grants, the Title X statute was not enacted as a federal-state cooperative statute, as is made clear by the eligibility of nonprofit, private entities to apply for grants directly. And, since the Department is free to attach reasonable conditions to the awarding of funds to carry out best its statutory goals and these conditions only apply to the receipt of federal Title X funds, states that object to the rule requirements or believe that there is a conflict with state law priorities are free to opt out of the federal grant program. Thus, the final rule does not interfere with state laws or have federalism implications, as state laws are only implicated if those states with contrary state laws wish to apply for Title X funds. D. Summary of Changes The Department has revised the economic analysis of impacts to account for additional information, newer data, and in response to comments. Many of the estimates and Tables have been updated to account for minor revisions to the calendar year 2020 data. For example, Table D1 now identifies 75 E:\FR\FM\07OCR3.SGM 07OCR3 56170 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations Grantees, 867 Subrecipients, 3,031 Service Sites, and 1,536,743 Clients Served, compared to 73 Grantees, 803 Subrecipients, 2,682 Service Sites, and 1,536,744 Clients Served reported in the PRIA. These revised estimates carry through to other estimates and Tables. As described in greater detail in the Preamble, the final rule adopts eight of the fourteen revisions initially proposed in the NPRM and nine of the ten technical corrections initially proposed in the NPRM as final without additional changes. 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 compared to what was proposed in the NPRM. This analysis has been updated to be consistent with these changes, but these changes do not substantially alter the estimates of the quantified economic impacts. E. Final Economic Analysis of Impacts a. Background The Title X family planning program, administered by the U.S. Department of Health and Human Services (HHS), Office of Population Affairs (OPA), is the only federal program dedicated solely to supporting the delivery of family planning and related preventive healthcare. The program is designed to provide ‘‘a broad range of acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services for adolescents)’’ with priority given to persons from lowincome families. In addition to offering these methods and services on a voluntary and confidential basis, Title X-funded service sites provide contraceptive education and counseling; breast and cervical cancer screening; STIs and HIV testing, referral, and prevention education; and pregnancy diagnosis and counseling. The program is implemented through competitively awarded grants to state and local public health departments and family planning, community health, and other private nonprofit agencies. In fiscal year 2021, the Title X program received approximately $286.5 million in discretionary funding.14 On March 4, 2019, HHS published a final rule to ‘‘prohibit family planning projects from using Title X funds to encourage, promote, provide, refer for, or advocate for abortion as a method of family planning; require assurances of compliance; eliminate the requirement that Title X projects provide abortion counseling and referral; require physical and financial separation of Title X activities from those which are prohibited under section 1008; provide clarification on the appropriate use of funds in regard to the building of infrastructure, and require additional reporting burden from grantees.’’ b. Market Failure or Social Purpose Requiring Federal Regulatory Action The regulatory impact analysis associated with the 2019 rule predicted that the additional restrictions on grantees would result in ‘‘an expanded number of entities interested in participating in Title X.’’ Further, the analysis suggested the 2019 rule would result in ‘‘enhanced patient service and care.’’ Contrary to these predictions, during the initial period of the 2019 rule’s implementation, the policy appears to have had the opposite effect. As described in greater detail in the Baseline section, the restrictions included in the 2019 rule are associated with a substantial reduction in the number of Title X grantees, subrecipients, and service sites, resulting in a corresponding reduction in total clients served. The Department is compelled to act quickly to ameliorate these negative consequences by promulgating this final rule since the Title X program serves a low-income population that is particularly vulnerable to losing access to these services. This final rule is needed to improve the functioning of government and the effectiveness of the Title X program. c. Purpose of the Rule This final rule will revise the regulations that govern the Title X family planning services program by revoking the 2019 rule and readopting the 2000 regulations with several modifications. This approach will allow the Title X program grantees, subrecipients, and service sites to have a greater impact on public health than under the current regulatory approach. d. Baseline Conditions and Impacts Attributable to the Rule The Department adopts a baseline that assumes the requirements of the 2019 rule remain in place over the period of our analysis. To characterize the realworld impact of the Title X program under this regulatory approach, the Department developed an annual forecast of grantees, subrecipients, service sites, and total clients served. The key inputs to the forecast are historical data on Title X service grantees. For calendar years 2016 to 2020, this information is summarized in the 2020 Title X Family Planning Annual Report. TABLE D1—TITLE X SERVICE GRANTEES Year Grantees .............................................................................. Subrecipients ....................................................................... Service Sites ........................................................................ Clients Served ...................................................................... 2016 2017 2018 2019 2020 91 1,117 3,898 4,007,552 89 1,091 3,858 4,004,246 99 1,128 3,954 3,939,749 100 1,060 3,825 3,095,666 75 867 3,031 1,536,743 lotter on DSK11XQN23PROD with RULES3 Source: Title X Family Planning Annual Report, 2020: Exhibit A–2a. The data for calendar years 2016– 2019 included all grantees, subrecipients, and service sites operating at any time during the year. The implementation of the 2019 rule occurred mid-year in 2019. Following this regulation, 19 grantees, 231 subrecipients, and 945 service sites withdrew from the Title X program. The 14 Does reduced number of grantees, subrecipients, services sites, and clients served observed in 2019 and 2020 cannot be explained by a reduction in discretionary funding for the program, which has remained constant at $286.5 million throughout this time period. Since the 2019 figure includes clients served by these service sites for more than half of the year, adopting 3.1 million clients served as an annual forecast would likely overstate activity in the program under the current regulations. Indeed, preliminary figures for 2020 approximate that only 1.5 million clients were served. However, this figure likely represents an underestimate for a typical year of the not include supplemental funding. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 E:\FR\FM\07OCR3.SGM 07OCR3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations fewer clients received intrauterine devices (IUDs). For oral contraceptives and IUDs, this was a 27 percent reduction, and for hormonal implants, a 21 percent reduction. These percentages are similar in magnitude to the 21 percent reduction in clients served in 2019 compared to 2018. Additionally, 90,386 and 188,920 fewer Pap tests and clinical breast exams, respectively, were performed in 2019 compared to 2018. Confidential HIV tests decreased by 276,109. Testing for STIs decreased by 256,523 for chlamydia, 625,802 for gonorrhea, and 77,524 for syphilis. Appendix A of the FPAR contains national annual trends for many of the services discussed above. The reductions in services reported in 2019 compared to 2018 represent the largest year-over-year reductions in services for each reported measure since at least 2014. Similar to the earlier discussion relating to long-term trends relating to clients, we attribute the bulk of the reductions to these services to the 2019 final rule. For the forecast of services provided under the baseline scenario, the Department adopts the percentage of TABLE D2—BASELINE FORECAST OF clients receiving each service in the TITLE X SERVICES 2019 Title X Family Planning Annual Baseline forecast Annual Report. For example, in 2019, about 23 percent of female clients received a Grantees ..................................... 75 clinical breast exam. The Department Subrecipients .............................. 867 Service Sites ............................... 3,031 assumes the same share of clients will Clients Served ............................ 2,512,066 be served by Title X for screening and STI testing. Table D3 reports the best In addition to the reduction in estimate of the annual services provided grantees, subrecipients, service sites, under the baseline scenario. These and total client served, the Department services are described in greater detail notes that six states currently have no later in this Section. Title X services, including HI, ME, OR, UT, VT, and WA. There are six TABLE D3—BASELINE TITLE X CANadditional states that have limited Title CER SCREENING AND SEXUALLY X services, including AK, CT, MA, MN, TRANSMITTED INFECTION TESTING NH, and NY.15 In line with the reduction in clients Year Annual served under the 2019 rule, data also reveal a significant drop in services Clinical Breast Exams ................ 509,550 provided. For example, when Pap Tests ................................... 443,087 comparing 2019 figures to 2018, 225,688 Chlamydia Test ........................... 1,266,508 fewer clients received oral Gonorrhea Test .......................... 1,420,198 contraceptives; 49,803 fewer clients Syphilis Test ............................... 536,619 received hormonal implants; and 86,008 program under the current regulations since services were likely disrupted by the ongoing public health emergency. As the primary estimate, the Department adopts 2,512,066 clients served as the baseline annual impact of Title X under the policies of the 2019 rule. This 2.5 million-figure corresponds to the number of clients served in 2019 among remaining grantees as of March 2021. For comparison, this primary estimate represents a 37 percent reduction in clients served compared to the average of clients served from 2016 to 2018. In the Uncertainty and Sensitivity Analysis Section, the Department adopts the 1.5 millionclient figure as a lower-bound estimate, and 3.1 million clients as an upperbound estimate of the annual program impact under the baseline. Table D2 summarizes the baseline forecast for the same categories of historical data presented in Table D1. The Department adopts the current count for grantees, subrecipients, and services sites and assumes constant funding and that these figures will be constant over the time horizon of this analysis. 56171 TABLE D3—BASELINE TITLE X CANCER SCREENING AND SEXUALLY TRANSMITTED INFECTION TESTING— Continued Year Annual Confidential HIV Test ................. 777,536 Source: Calculations based on Title X Family Planning Annual Report, 2019: Exhibits 26 and 29. The Department predicts that the main effect of the final rule would be to return to Title X program impact levels observed prior to the 2019 rule. The estimates of the long-run equilibrium of grantees, subrecipients, service sites, and total clients served are informed by the data from 2016 to 2018, the last three years of data that are unaffected by the declines experienced following the 2019 rule. Specifically, the Department adopts the average across these three years as the long-run estimates. These averages are 93 grantees, 1,112 subrecipients, 3,903 service sites, and approximately 4.0 million clients served. To complete the forecast of the policy scenario, the Department assumes that it will take two years for program participation and clients served to achieve the long-run equilibrium estimates. This two-year phase-in is consistent with a scenario in which most service sites that withdrew from the Title X program have remained open, with some operating at a lower capacity, than they did prior to the 2019 rule. It is also consistent with an expectation that many of the grantees and service sites that withdrew from the program would be able to rejoin if the NPRM issued on April 15, 2021, were finalized. In year one, following the effective date of the proposed rule, the number of clients served would increase to approximately 3.2 million. In year two, this number would increase again to approximately 4.0 million and remain constant for the duration of the analysis. These figures are presented in Table D4. The Department acknowledges uncertainty in this estimate and includes a discussion in the Uncertainty and Sensitivity Section, below. TABLE D4—POLICY SCENARIO FORECAST OF TITLE X SERVICE GRANTEES lotter on DSK11XQN23PROD with RULES3 Year Grantees .............................................................................. Subrecipients ....................................................................... Service Sites ........................................................................ Clients Served ...................................................................... 15 As noted earlier, seven states (CO, DE, KY, ND, NM, NV, TX) experienced a meaningful increase in VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 2022 2023 2024 2025 2026 84 990 3,467 3,247,958 93 1,112 3,903 3,983,849 93 1,112 3,903 3,983,849 93 1,112 3,903 3,983,849 93 1,112 3,903 3,983,849 the number of Title X clinics after the 2019 regulatory change. PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 E:\FR\FM\07OCR3.SGM 07OCR3 56172 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations To characterize the effect of the final rule, the Departments compares the policy scenario forecast to the baseline forecast described in the previous section. Table D5 reports the difference between these two scenarios, which represents the net effect of the proposed rule. For example, in year one after this rule is effective, the number of clients served would increase by approximately 736,000 as compared to the baseline scenario. Approximately 88 percent of clients served in 2016 to 2018 are female, and the Department uses this percentage to estimate the increase in clients served by sex under the policy scenario. TABLE D5—EFFECT OF THE PROPOSED RULE ON TITLE X SERVICES Year 2022 Increase in Grantees ........................................................... Increase in Subrecipients .................................................... Increase in Service Sites ..................................................... Increase in Clients Served ................................................... Female .......................................................................... Male .............................................................................. Clients served under the Title X program experience outcomes that include reducing unintended pregnancy through greater access to contraception. The averted unintended pregnancies translate to a reduction in unplanned births, a reduction in abortions, and reduction in miscarriages. Also, Title X clients receive cancer screenings and testing for STIs. These screenings and testing can identify treatable conditions, improving the quality of life and extending the lives of beneficiaries. In the case of STIs, additional testing and corresponding earlier treatment can reduce the likelihood of worse health outcomes and future infertility resulting from those infections. This final rule will expand service to socioeconomically disadvantaged populations, most of whom are female, 9 123 436 735,892 648,996 86,896 2023 2024 2025 2026 18 245 872 1,471,783 1,297,992 173,791 18 245 872 1,471,783 1,297,992 173,791 18 245 872 1,471,783 1,297,992 173,791 18 245 872 1,471,783 1,297,992 173,791 low-income, and young. The Department discusses this in greater detail in the Section on Distributional Effects. To further explore the likely effect of the Title X program on unintended pregnancy, we rely on existing methodology for estimating number of unintended pregnancies prevented each year among U.S. women who depend on publicly funded family planning services.16 Among this subgroup of women who use any method of contraception, 46 in 1,000 women are expected to experience an unintended pregnancy. This figure can be compared to 296 unintended pregnancies per 1,000 women who are unable to access publicly funded family planning services. The Department applies this estimate of a reduction of 250 unintended pregnancies per 1,000 contraception clients to the number of additional female clients served under the Title X program who adopt any method of contraception. For year one, the analysis reflects multiplying 735,892 clients by 88 percent to yield 648,996 female clients. Among female clients, approximately 14 percent indicate they are not using a method of contraception, according to figures in the 2019 Title X Family Planning Annual Report. The analysis reduces the potential number of clients that would potentially reduce the likelihood of an unintended pregnancy by 14 percent to yield 558,205 clients expected to benefit from a contraceptive method. Approximately 47 percent of unintended pregnancies result in births, 34 percent in abortion, and 19 percent in a miscarriage.17 TABLE D6—EFFECT OF THE PROPOSED RULE ON TITLE X-ASSOCIATED CONTRACEPTION Year 2022 lotter on DSK11XQN23PROD with RULES3 Clients Served ...................................................................... Women Served .................................................................... Women Served Using Contraception .................................. 735,892 648,996 558,205 2023 2024 2025 2026 1,471,783 1,297,992 1,116,411 1,471,783 1,297,992 1,116,411 1,471,783 1,297,992 1,116,411 1,471,783 1,297,992 1,116,411 Unintended pregnancies increase the risk for poor maternal and infant outcomes. Women who give birth following an unintended pregnancy are less likely to have benefitted from preconception care, to have optimal spacing between births, and to have been aware of their pregnancy early on, which in turn makes it less likely that they would have received prenatal care early in pregnancy.18 19 Title X funding recipients also perform preventive health services such as cervical and breast cancer screening, and testing for STIs, including chlamydia, gonorrhea, syphilis, and HIV. Table D7 presents the effect of the final rule on Title X-associated cervical and breast cancer screenings. These figures are calculated by multiplying the number of additional women served by the program in each year by approximately 23 percent for clinical breast exams, of which five percent result in a referral for further evaluation; and 20 percent for Pap testing, of which 13 percent with a result of atypical squamous cells (ASC) that require further evaluation and possibly 16 Jennifer J. Frost and Lawrence B. Finer (2017). Memo entitled ‘‘Unintended pregnancies prevented by publicly funded family planning services: Summary of results and estimation formula.’’ https://www.guttmacher.org/sites/default/files/ pdfs/pubs/Guttmacher-Memo-on-Estimation-ofUnintended-Pregnancies-Prevented-June-2017.pdf. Accessed on March 14, 2021. 17 Jennifer J. Frost, Lori F. Frohwirth, Nakeisha Blades, Mia R. Zolna, Ayana Douglas-Hall, and Jonathan Bearak (2017). ‘‘Publicly Funded Contraceptive Services at U.S. Clinics, 2015. https://www.guttmacher.org/sites/default/files/ report_pdf/publicly_funded_contraceptive_ services_2015_3.pdf. Accessed on March 14, 2021. 18 Jessica D. Gipson, Michael A. Koenig, and Michelle J. Hindin. ‘‘The Effects of Unintended Pregnancy on Infant, Child, and Parental Health: A Review of the Literature.’’ Studies in family planning 39.1 (2008): 18–38. Web. 19 Power to Decide. Maternal and Infant Health and the Benefits of Birth Control in America. Accessed on March 8, 2020 from https://powerto decide.org/sites/default/files/resources/supportingmaterials/getting-the-facts-straight-chapter-3maternal-infant-health.pdf. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 E:\FR\FM\07OCR3.SGM 07OCR3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations treatment, and one percent of which have a high-grade squamous intraepithelial lesion (HSIL) 20 or higher, indicating the presence of a more severe condition. Clinical breast exams can identify patients requiring further evaluation of an abnormal finding. Pap tests (or pap smear tests) can detect precancers and cervical cancer cells and can also be tested for viral infections that can turn 56173 into cervical cancer. At a population level, these screenings save lives by helping patients identify cancer earlier and by preventing other conditions from developing into cancer. TABLE D7—EFFECT OF THE FINAL RULE ON TITLE X-ASSOCIATED CERVICAL AND BREAST CANCER SCREENING ACTIVITIES Year 2022 Clinical Breast Exams .......................................................... Referred ............................................................................... Pap Tests ............................................................................. Tests with ASC or higher ............................................. Tests with HSIL or higher ............................................. Table D8 presents the effect of the proposed rule on Title X-associated testing for STIs among female clients. These are calculated by adopting estimates that 49 percent of women are 2023 149,269 7,463 129,799 17,304 195 298,538 14,927 259,598 34,609 391 tested for chlamydia, 55 percent for gonorrhea, 19 percent for syphilis, and 28 percent for HIV. Table D9 presents the same information for men. The share of male clients tested for these 2024 2025 298,538 14,927 259,598 34,609 391 298,538 14,927 259,598 34,609 391 2026 298,538 14,927 259,598 34,609 391 infections are the following: 61 percent for chlamydia, 68 percent for gonorrhea, 39 percent for syphilis, and 53 percent for HIV. TABLE D8—ADDITIONAL WOMEN TESTED FOR SEXUALLY TRANSMITTED INFECTIONS UNDER TITLE X Year 2022 Chlamydia ............................................................................ Gonorrhea ............................................................................ Syphilis ................................................................................. Confidential HIV ................................................................... 2023 318,008 356,948 123,309 181,719 636,016 713,895 246,618 363,438 2024 2025 636,016 713,895 246,618 363,438 636,016 713,895 246,618 363,438 2026 636,016 713,895 246,618 363,438 TABLE D9—ADDITIONAL MEN TESTED FOR SEXUALLY TRANSMITTED INFECTIONS UNDER TITLE X Year 2022 Chlamydia ............................................................................ Gonorrhea ............................................................................ Syphilis ................................................................................. Confidential HIV ................................................................... Table D10 reports the additional total clients tested for STIs under Title X. These tests can identify treatable conditions that can cause discomfort, permanent damage to reproductive systems including infertility, and in certain cases, death. The 2019 Title X Family Planning Annual Report indicates confidential HIV testing identifies a positive case for 2023 53,006 59,089 33,889 46,055 106,013 118,178 67,779 92,109 approximately 0.38 percent of all HIV tests performed. Under the final rule, testing under Title X is estimated to identify an additional 873 positive cases of HIV in the first year. In subsequent years, this estimate increases to 1,745. Testing for these STIs can also reduce the likelihood that an individual will spread an infection. In addition to testing, Title X-funded service sites also 2024 2025 106,013 118,178 67,779 92,109 106,013 118,178 67,779 92,109 2026 106,013 118,178 67,779 92,109 provide HIV/AIDS prevention education. Pre-exposure prophylaxis (PrEP) has emerged as an effective HIV prevention strategy for individuals who are most at risk, and the inclusion of PrEP in the HIV prevention services provided at Title X sites is becoming an increasingly important method for protecting individuals of all ages from acquiring HIV. TABLE D10—ADDITIONAL CLIENTS TESTED FOR SEXUALLY TRANSMITTED INFECTIONS UNDER TITLE X Year 2022 lotter on DSK11XQN23PROD with RULES3 Chlamydia ............................................................................ Gonorrhea ............................................................................ Syphilis ................................................................................. Confidential HIV ................................................................... Positive Test Results ........................................................... Additional services of the type provided under Title X will likely result 2023 371,014 416,037 157,199 227,774 873 742,029 832,074 314,397 455,547 1,745 in reduced costs to taxpayers in line with a reduction in unintended 2024 2025 742,029 832,074 314,397 455,547 1,745 22:06 Oct 06, 2021 Jkt 256001 PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 742,029 832,074 314,397 455,547 1,745 pregnancies, pre-term and low birth weight births, STIs, infertility, and 20 HSIL is the abnormal growth of certain cells on the surface of the cervix. VerDate Sep<11>2014 742,029 832,074 314,397 455,547 1,745 2026 E:\FR\FM\07OCR3.SGM 07OCR3 56174 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES3 cervical cancer. One report estimates that each dollar spent on these services results in a net government saving of $7.09.21 We do not replicate the calculations, but note that they are derived from cost savings associated with averting unintended pregnancy and complications such as pre-term and low birth weight births. These cost savings are also derived from detecting and treating STIs that would have resulted in more serious outcomes, including infertility, cancer, and death. In addition to the effects described above, the final rule will also enhance the equity and dignity associated with access to family planning services provided by Title X. A recent research brief summarized interviews with 30 women sharing their experiences with contraceptive access, providing suggestive evidence that birth control has an important positive impact on women’s lives. Interviewees noted that birth control allowed women to ‘‘to pursue academic and professional goals, achieve financial stability, and maintain their mental and physical health.’’ 22 These recent interviews are consistent with the historical experience of the importance of birth control. For example, one econometric study identifies a causal relationship between the introduction and diffusion of the birth control pill and the increase in women enrolling in professional degree programs and increasing the age at first marriage.23 As of a result of the Affordable Care Act’s contraceptive coverage requirement, Title X can play a critical role, helping provide insured clients with access to contraception without cost-sharing alongside its longstanding role supporting contraceptive access without costsharing for Medicaid beneficiaries and those whose incomes are equal to or less than 100 percent of the federal poverty level (FPL), which allows these clients to experience these and other positive outcomes associated with access to contraception. Researchers have identified other economic, social, and health impacts of increased access to family planning, 21 Jennifer J. Frost, Adam Sonfield, Mia R. Zolna, and Lawrence B. Finer (2014). ‘‘Return on Investment: a fuller assessment of the benefits and costs of the US publicly funded family planning program.’’ Milbank Quarterly 2014 Dec; 92(4): 696– 749. 22 Rebecca Peters, Sarah Benetar, Brigette Courtot, and Sophia Yin (2019). ‘‘Birth Control is Transformative.’’ Urban Institute. https:// www.urban.org/sites/default/files/publication/ 99912/birth_control_is_transformative_1.pdf. Accessed April 6, 2021. 23 Goldin, Claudia and Lawrence F. Katz (2002). ‘‘The power of the pill: Oral contraceptives and women’s career and marriage decisions.’’ Journal of Political Economy 110(4): 730–770. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 contraception, and treatment. For example, Bailey et al. (2019) finds ‘‘that children born after the introduction of federal family planning programs were seven percent less likely to live in poverty and 12 percent less likely to live in households receiving public assistance.’’ They perform an additional bounding analysis, which suggests that about two thirds of the estimated gains are due to increases in the incomes of parents.24 A recent summary discusses other impacts of access to family planning services in the United States and in other countries, which extends beyond women and girls, to their children and wider communities.25 The tables above present observable metrics of the effect of the Title X program, which is important for evaluating the direct effect of the program. For this reason, the scope of the analysis initially focuses on clients served and services provided by Title Xfunded sites. To properly account for the net effect of the final rule when comparing the baseline scenario to the policy scenario, the Department would need to assess the extent to which clients and services continue to be provided through other channels than Title X-funded sites without the proposed rule. As a general matter, the impacts of this final rule may include: • Transfers between grantees and prospective grantees within the Title X program; • other transfers (for example, if Title X newly funds medical services that would, in the absence of the proposed rule, be provided by charitable organizations or other private payers); and • societal benefits and costs to the extent that the volume or characteristics (such as location, which determines travel costs) of medical services would differ with and without the final rule. As noted earlier in this preamble, all Planned Parenthood affiliates—which, in 2015, served 41 percent of all contraceptive clients at Title X-funded service sites—withdrew from Title X, citing the 2019 rule. However, a comparison of Planned Parenthood’s two most recent annual financial reports indicates no subsequent decrease in the number of patients served and an increase, from 9.8 million to 10.4 million, in the number of services 24 Bailey, Martha J., Olga Malkova, Zoe ¨ M. McLaren (2019). ‘‘Does Access to Family Planning Increase Children’s Opportunities? Evidence from the War on Poverty and the Early Years of Title X.’’ Journal of Human Resources 54:4 pp. 825–856. doi:10.3368/jhr.54.4.1216–8401R1. 25 Emily Sohn (2020). ‘‘Strengthening society with contraception.’’ Nature 588, S162–S164. PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 provided per annum (pre-pandemic).26 Although such year-to-year comparisons are simplistic and a focus on just one organization (even a prominent one, with extensive activities) has obvious limitations, this evidence may suggest that the Title X program impacts quantified elsewhere in this regulatory impact analysis may largely be associated with transfers. The Department received a number of public comments drawing connections between the short-term effects of the 2019 rule and long-term potential for a reduction in total family planning clients served, not limited to the Title X program. For example, two states (NY, WA) reported receiving emergency reserve funds through state funding in order to sustain the level of care that they provided under Title X; however, both noted that this funding is not reliable and sustainable from year to year. One grantee in Maine reported keeping all clinics open and operating with the use of the association’s reserve funds and through private fundraising, which was an unsustainable and impractical task to continue. Another provider also reported fundraising to maintain care while also noting the administrative burden; however, many health centers were forced to close or reduce hours due to the lack of Title X funding. The same organization also reported the need to scale back or eliminate education and outreach programs in many states. These public comments suggest that the long-term effect of the 2019 rule would have been to reduce clients served and family planning services provided beyond the Title X program. In addition to the effects on the quantity of services, several comments discussed the effects on the quality of services provided. One organization and the Attorneys General of 22 states and the District of Columbia noted that losing Title X providers had a negative effect on patients that sought care. They argued that it was more difficult for patients to obtain culturally competent care and that the requirements of the 2019 rule placed a burden on providers and their method of pregnancy counseling, as they were ‘‘inconsistent with the standards of care and required incomplete and confusing lists and referrals for pregnant clients.’’ Finally, several states reported that while their efforts were refocused to recruiting and 26 Please see https://www.planned parenthood.org/uploads/filer_public/2e/da/ 2eda3f50-82aa-4ddb-acce-c2854c4ea80b/20182019_annual_report.pdf and https://www.planned parenthood.org/uploads/filer_public/67/30/ 67305ea1-8da2-4cee-9191-19228c1d6f70/210219annual-report-2019-2020-web-final.pdf. E:\FR\FM\07OCR3.SGM 07OCR3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations onboarding new providers into their Title X network under the 2019 rule, they faced resistance or a lack of interest, and their provider networks did not increase under the 2019 rule, continuing to adversely impact the communities they serve. These public comments suggest that the effects identified in this regulatory impact analysis for the time horizon covering calendar year 2022 through 2026 are unlikely to be limited to a reversal of what was observed immediately after issuance of the 2019 final rule. The Department acknowledges persistent challenges with clearly disaggregating the effects that represent transfers from effects that represent benefits and costs as a result of this final rule; however, it is important to reiterate that total Title X funding remained unchanged upon issuance of the 2019 final rule and will be unchanged as a result of this final rule, so while some entities receive less funding (and they and their clients experience regulation-induced ancillary harm, which can manifest itself in the quantity or quality of associated services), other entities receive more funding. The Department maintains the analytical approach of estimating the number of additional clients served and services provided under the Title X program under this final rule, while acknowledging challenges in quantitatively assessing whether this final rule will result in additional clients served and family planning services provided, not limited to the Title X program, as compared to the baseline of no further regulatory action. Despite such uncertainty, analysis based on evidence available at this time generally supports a conclusion that the projections accompanying the 2019 rule have not been borne out. e. Further Discussion of Distributional Effects The Title X program is designed to provide services with priority given to persons from low-income families. According to the 2019 figures, 64 percent of clients have income under 101% of the federal poverty level; 14 percent between 101 percent FPL and 150 percent FPL; seven percent between 151 percent FPL to 200 percent FPL; three percent between 201 percent FPL and 250 percent FPL; seven percent over 250 percent FPL; and five percent have an unknown or unreported income level. Among program clients, 33 percent self-identified as Hispanic or Latino of all races; three percent as Asian and Not Hispanic or Latino; 22 percent as Black or African American and Not Hispanic or Latino; 32 percent as White and Not Hispanic or Latino; five percent as Other or Unknown and Not Hispanic or Latino; and four percent are Unknown or Not Reported. Furthermore, Title X requires Title X projects to provide services for adolescents without required parental consent, thereby making Title X a critical source of sexual and reproductive healthcare for young people. In 2019, two percent of program clients were younger than 15, and eight percent were younger than 18. Additional information about the number and distribution of all family planning clients by age and year are available in Exhibit A–3a of the 2019 Family Planning Annual Report. The benefits of revoking the 2019 rule would likely accrue proportionally with these income and race and ethnicity figures. The costs of revoking the 2019 rule would likely accrue proportionally to the income and other demographics of the general public. This final rule will also likely have important geographic effects. As described in greater detail in the 56175 Baseline section, six states currently have no Title X services, and six additional states have limited Title X services. This final rule is expected to result in restoration of services to individuals in these states. f. Uncertainty and Sensitivity Analysis All of the major drivers of the quantified effects of this analysis are dependent on the forecast of the baseline number of clients served. The Department acknowledges the uncertainty in this baseline and has performed a sensitivity analysis to quantify its importance. For the primary baseline, the analysis uses 2.5 million annual clients of Title X services, which corresponds to the number of clients in calendar year 2019 among remaining grantees. For its sensitivity analysis, the Department investigates the effect of the proposed rule compared to a baseline with 1.5 million clients, corresponding to the estimates for 2020. For comparison, the analysis reviewed the effects using an upper bound of 3.1 million clients served, which is the reported figure for 2019, but which includes 19 grantees, 231 subrecipients, and 945 service sites that withdrew from the Title X program following the 2019 rule. Table F1 presents the number of clients served under different assumptions of the baseline. The analysis also recalculates the number of clients served for the final rule scenario for each of the baseline assumptions. Since the number of clients served in the first year is the midpoint between the baseline and long-run equilibrium figure, the number of clients served in 2022 under the final rule is lower for the lower-bound scenario than the primary baseline. Similarly, the number of clients served under the final rule is higher in the upper-bound scenario. TABLE F1—TITLE X CLIENTS SERVED UNDER DIFFERENT BASELINE ASSUMPTIONS Year lotter on DSK11XQN23PROD with RULES3 2022 2023 2024 2025 2026 Baseline ......................................................... ......................................................... ......................................................... ......................................................... ......................................................... 2,512,066 2,512,066 2,512,066 2,512,066 2,512,066 Table F2 calculates the effect of the final rule under different baseline assumptions. These estimates are reported by year, as well as in present value and annualized for the five-year time horizon of the analysis, applying a VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 Baseline, LB Baseline, UB 1,536,743 1,536,743 1,536,743 1,536,743 1,536,743 3,095,666 3,095,666 3,095,666 3,095,666 3,095,666 three percent and a seven percent discount rate. Under the lower-bound baseline scenario, the final rule will have about a 66 percent greater impact on the number of clients served in annualized terms under the primary PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 Proposed rule 3,247,958 3,983,849 3,983,849 3,983,849 3,983,849 Proposed rule, LB Proposed rule, UB 2,760,296 3,983,849 3,983,849 3,983,849 3,983,849 3,539,758 3,983,849 3,983,849 3,983,849 3,983,849 baseline scenario. Under the upperbound baseline scenario, the final rule will have approximately a 64 percent lesser impact. E:\FR\FM\07OCR3.SGM 07OCR3 56176 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations TABLE F2—EFFECT OF THE PROPOSED RULE ON TITLE X CLIENTS UNDER DIFFERENT BASELINE ASSUMPTIONS Year 2022 ............................................................................................................................................. 2023 ............................................................................................................................................. 2024 ............................................................................................................................................. 2025 ............................................................................................................................................. 2026 ............................................................................................................................................. PDV, 3% ...................................................................................................................................... PDV, 7% ...................................................................................................................................... Annualized, 3% ............................................................................................................................ Annualized, 7% ............................................................................................................................ As discussed earlier, the Department acknowledges uncertainty in how quickly the Title X program will be able to restore service to levels experienced prior to the declines associated with the 2019 rule. The primary analysis adopts a two-year phase for grantees, subrecipients, service sites, and clients served to reach the long-run equilibrium estimates. If a large number of service Proposed rule Proposed rule, LB Proposed rule, UB 735,892 1,471,783 1,471,783 1,471,783 1,471,783 6,025,877 5,346,852 1,315,778 1,304,047 1,223,553 2,447,106 2,447,106 2,447,106 2,447,106 10,019,113 8,890,110 2,187,719 2,168,215 444,092 888,183 888,183 888,183 888,183 3,636,461 3,226,687 794,038 786,959 estimates that adopt alternative assumptions about the length of time it will take to reach the long-run equilibrium estimates. Table F3 presents the primary estimates of clients served, based on a two-year phase-in, estimates without a phase-in, and estimates with a three-year phase-in assumption. sites have shut down permanently, the assumption of a two-year phase-in would likely result in an overestimate of the final rule’s effect over the time horizon of the analysis. Similarly, if a small number of service sites have shut down, the analysis would tend to underestimate the effect of the final rule. Therefore, as a second sensitivity analysis, the Department presents TABLE F3—TITLE X CLIENTS WITH DIFFERENT PHASE-IN ASSUMPTIONS Year 2022 2023 2024 2025 2026 Baseline ................................................................................................................. ................................................................................................................. ................................................................................................................. ................................................................................................................. ................................................................................................................. Table F4 calculates the effect of the final rule with different phase-in assumptions. These estimates are reported by year, as well as in present value and annualized for the five-year Proposed rule, 2-year phase-in Proposed rule, no phase-in Proposed rule, 3-year phase-in 3,247,958 3,983,849 3,983,849 3,983,849 3,983,849 3,983,849 3,983,849 3,983,849 3,983,849 3,983,849 3,002,660 3,493,255 3,983,849 3,983,849 3,983,849 2,512,066 2,512,066 2,512,066 2,512,066 2,512,066 time horizon of the analysis, applying a three percent and a seven percent discount rate. Compared to the primary estimates, the assumption of no phasein yields annualized effects of the final rule that are approximately 12 percent higher. Assuming a three-year phase-in yields annualized effects that are about 12 percent lower than the primary estimates. TABLE F4—EFFECT OF THE PROPOSED RULE ON TITLE X CLIENTS WITH DIFFERENT PHASE-IN ASSUMPTIONS Year Proposed rule, 2-year phase-in Proposed rule, no phase-in Proposed rule, 3-year phase-in 735,892 1,471,783 1,471,783 1,471,783 1,471,783 6,025,877 5,346,852 1,315,778 1,304,047 1,471,783 1,471,783 1,471,783 1,471,783 1,471,783 6,740,335 6,034,601 1,471,783 1,471,783 490,594 981,189 1,471,783 1,471,783 1,471,783 5,325,293 4,689,098 1,162,802 1,143,627 2022 ............................................................................................................................................. 2023 ............................................................................................................................................. 2024 ............................................................................................................................................. 2025 ............................................................................................................................................. 2026 ............................................................................................................................................. PDV, 3% ...................................................................................................................................... PDV, 7% ...................................................................................................................................... Annualized, 3% ............................................................................................................................ Annualized, 7% ............................................................................................................................ lotter on DSK11XQN23PROD with RULES3 g. Analysis of Regulatory Alternatives to the Proposed Rule The Department analyzed two alternatives to the approach under the final rule. The Department considered one option to maintain many elements of the 2019 rule and to impose additional restrictions on grantees. This VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 approach would exacerbate the trends of reduced Title X grantees, subrecipients, service sites, and clients served that we have observed under the 2019 rule. Second, the Department considered revising the 2019 rule by readopting many elements of the 2000 regulations, but adopting additional flexibilities for PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 grantees and reducing programmatic oversight. However, experience suggests the compliance regime as it existed prior to the 2019 rule was effective. IV. Environmental Impact The Department has determined under 21 CFR 25.30(k) that this action E:\FR\FM\07OCR3.SGM 07OCR3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. V. Paperwork Reduction Act This final rule contains information collection requirements (ICRs) that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. No public comments were provided on the proposed information collections for § 59.4, 59.5, and 59.7 proposed in the NPRM. OMB filed comment on this NPRM and assigned OMB Control Number 0970–0211. As previously stated in the preamble, the final rule is revoking the 2019 final rule in its entirety. As a result, the final rule does not include information data collection required under § 59.5(a)(12) to provide documentation or assurance to HHS of a plan to comply with state notifications laws, and it does not include the requirement under § 59.5(a)(13) to report information to HHS on subrecipients. However, additional information collection was identified related to § 59.4, 59.5, and 59.7. The final rule is revising the information collections to reflect the additional estimated burden for the Title X grant requirements under § 59.4, 59.5, and 59.7. A description of these provisions is given in the following paragraphs with an estimate of the annual burden, summarized in Table 1. § 59.4 requires Title X grant applicants to describe how the proposed project would satisfy the regulatory requirements for the Title X program in their applications, including the specific project requirements under § 59.5 and the grant review criteria specified under § 59.7. We estimate that the time necessary for each Title X applicant to include this information in their grant applications would be 70 hours. All other reporting burden associated with grant applications is already approved via existing Grants.gov common forms. 56177 Burden of Response: The Department is committed to leveraging existing grant, contract, annual reporting, and other Departmental forms where possible, rather than creating additional, separate forms for recipients to sign. The burden for describing the Title X grant requirements is the cost for each applicant to include this information in their grant applications. The labor cost would consist of a medical and health service manager spending an average of 70 hours writing and incorporating the Title X program information in their grant applications. The Department estimates the number of applicants at 136, based on the number of eligible applicants who applied to the Title X national grant competition before the 2019 final rule was in effect. The mean hourly wage (not including benefits and overhead) is $55.37 per hour for the medical and health service manager.27 The labor cost per application is $3,875.90. ($55.37 × 70 hours), and the total labor cost is $527,122.40 ($3,875.90 × 136 applications). TABLE 1—ESTIMATED BURDEN FOR DESCRIBING THE TITLE X GRANT REQUIREMENTS IN THE GRANT APPLICATION FOLLOWING PUBLICATION OF THE FINAL RULE OMB control No. Regulation burden Hourly rate ($) Burden per response (hours) Total annual burden (hours) Labor cost of application ($) Title X Grant Requirements ..................... 0970–0211 136 55.37 70 9,520 527,122.40 Total cost .......................................... ........................ ........................ ........................ ........................ ........................ 527,122.40 59.4 List of Subjects in 42 CFR Part 59 Family planning, Grant programshealth, Health professions, Abortion, Birth control, Title X. Xavier Becerra, Secretary, Department of Health and Human Services. 42 CFR Part 59 PART 59—GRANTS FOR FAMILY PLANNING For the reasons set out in the preamble, subpart A of part 59 of title 42, Code of Federal Regulations, is revised to read as follows: lotter on DSK11XQN23PROD with RULES3 Applicant responses How does one apply for a family planning services grant? 59.5 What requirements must be met by a family planning project? 59.6 What procedures apply to assure the suitability of informational and educational material (print and electronic)? 59.7 What criteria will the Department of Health and Human Services use to decide which family planning services projects to fund and in what amount? 59.8 How is a grant awarded? 59.9 For what purposes may grant funds be used? 59.10 Confidentiality. 59.11 Additional conditions. Authority: 42 U.S.C. 300a-4. Subpart A—Project Grants for Family Planning Services Subpart A—Project Grants for Family Planning Services Sec. 59.1 § 59.1 To what programs do these regulations apply? To what programs do these regulations apply? 59.2 Definitions. 59.3 Who is eligible to apply for a family planning services grant? The regulations of this subpart are applicable to the award of grants under section 1001 of the Public Health Service Act (42 U.S.C. 300) to assist in the establishment and operation of voluntary family planning projects. These projects shall consist of the educational, comprehensive medical, and social services necessary to aid individuals to determine freely the number and spacing of their children. § 59.2 Definitions. As used in this subpart: Act means the Public Health Service Act, as amended. Adolescent-friendly health services are services that are accessible, acceptable, equitable, appropriate and effective for adolescents. Clinical services provider includes physicians, physician assistants, nurse practitioners, certified nurse midwives, and registered nurses with an expanded scope of practice who are trained and permitted by state-specific regulations to perform all aspects of the user (male and female) physical assessments recommended for contraceptive, related 27 2019 labor costs for medical and health service managers, https://www.bls.gov/oes/2019/may/ oes119111.htm. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 PO 00000 Frm 00035 Fmt 4701 Sfmt 4700 E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 56178 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations preventive health, and basic infertility care. Client-centered care is respectful of, and responsive to, individual client preferences, needs, and values; client values guide all clinical decisions. Culturally and linguistically appropriate services are respectful of and responsive to the health beliefs, practices and needs of diverse patients. Family means a social unit composed of one person, or two or more persons living together, as a household. Family planning services include a broad range of medically approved services, which includes Food and Drug Administration (FDA)-approved contraceptive products 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. Health equity is when all persons have the opportunity to attain their full health potential and no one is disadvantaged from achieving this potential because of social position or other socially determined circumstances. Inclusive is when all people are fully included and can actively participate in and benefit from family planning, including, but not limited to, individuals who belong to underserved communities, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality. Low-income family means a family whose total annual income does not exceed 100 percent of the most recent Poverty Guidelines issued pursuant to 42 U.S.C. 9902(2). ‘‘Low-income family’’ also includes members of families whose annual family income exceeds this amount, but who, as determined by the project director, are unable, for good reasons, to pay for family planning services. For example, unemancipated minors who wish to receive services on a confidential basis must be considered on the basis of their own resources. Nonprofit, as applied to any private agency, institution, or organization, means that no part of the entity’s net earnings benefit, or may lawfully benefit, any private shareholder or individual. VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 Quality healthcare is safe, effective, client-centered, timely, efficient, and equitable. Secretary means the Secretary of Health and Human Services (HHS) and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated. Service site is a clinic or other location where Title X services are provided to clients. Title X recipients and/or their subrecipients may have service sites. State includes, in addition to the several States, the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the U.S. Virgin Islands, American Samoa, the U.S. Outlaying Islands (Midway, Wake, et al.), the Marshall Islands, the Federated State of Micronesia, and the Republic of Palau. Trauma-informed means a program, organization, or system that is traumainformed realizes the widespread impact of trauma and understands potential paths for recovery; recognizes the signs and symptoms of trauma in clients, families, staff, and others involved with the system; and responds by fully integrating knowledge about trauma into policies, procedures, and practices, and seeks to actively resist retraumatization. § 59.3 Who is eligible to apply for a family planning services grant? Any public or nonprofit private entity in a State may apply for a grant under this subpart. § 59.4 How does one apply for a family planning services grant? (a) Application for a grant under this subpart shall be made on an authorized form. (b) An individual authorized to act for the applicant and to assume on behalf of the applicant the obligations imposed by the terms and conditions of the grant, including the regulations of this subpart, must sign the application. (c) The application shall contain (1) A description, satisfactory to the Secretary, of the project and how it will meet the requirements of this subpart; (2) A budget and justification of the amount of grant funds requested; (3) A description of the standards and qualifications which will be required for all personnel and for all facilities to be used by the project; and (4) Such other pertinent information as the Secretary may require. § 59.5 What requirements must be met by a family planning project? (a) Each project supported under this part must: PO 00000 Frm 00036 Fmt 4701 Sfmt 4700 (1) 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 prescription to the client for their method of choice or referrals to another provider, as requested. (2) Provide services without subjecting individuals to any coercion to accept services or to employ or not to employ any particular methods of family planning. Acceptance of services must be solely on a voluntary basis and may not be made a prerequisite to eligibility for, or receipt of, any other services, assistance from or participation in any other program of the applicant.1 (3) Provide services in a manner that is client-centered, culturally and linguistically appropriate, inclusive, and trauma-informed; protects the dignity of the individual; and ensures equitable and quality service delivery consistent with nationally recognized standards of care. (4) Provide services in a manner that does 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. (5) Not provide abortion as a method of family planning.2 A project must: (i) Offer pregnant clients the opportunity to be provided information 1 42 U.S.C. 300a–8 provides that any officer or employee of the United States, officer or employee of any State, political subdivision of a State, or any other entity, which administers or supervises the administration of any program receiving Federal financial assistance, or person who receives, under any program receiving Federal assistance, compensation for services, who coerces or endeavors to coerce any person to undergo an abortion or sterilization procedure by threatening such person with the loss of, or disqualification for the receipt of, any benefit or service under a program receiving Federal financial assistance shall be fined not more than $1,000 or imprisoned for not more than one year, or both. 2 Providers may separately be covered by federal statutes protecting conscience and/or civil rights. E:\FR\FM\07OCR3.SGM 07OCR3 lotter on DSK11XQN23PROD with RULES3 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations and counseling regarding each of the following options: (A) Prenatal care and delivery; (B) Infant care, foster care, or adoption; and (C) Pregnancy termination. (ii) If requested to provide such information and counseling, provide neutral, factual information and nondirective counseling on each of the options, and, referral upon request, except with respect to any option(s) about which the pregnant client indicates they do not wish to receive such information and counseling. (6) Provide that priority in the provision of services will be given to clients from low-income families. (7) Provide that no charge will be made for services provided to any clients from a low-income family except to the extent that payment will be made by a third party (including a government agency) which is authorized to or is under legal obligation to pay this charge. (8) Provide that charges will be made for services to clients other than those from low-income families in accordance with a schedule of discounts based on ability to pay, except that charges to persons from families whose annual income exceeds 250 percent of the levels set forth in the most recent Poverty Guidelines issued pursuant to 42 U.S.C. 9902(2) will be made in accordance with a schedule of fees designed to recover the reasonable cost of providing services. (i) Family income should be assessed before determining whether copayments or additional fees are charged. (ii) With regard to insured clients, clients whose family income is at or below 250 percent of the FPL should not pay more (in copayments or additional fees) than what they would otherwise pay when the schedule of discounts is applied. (9) Take reasonable measures to verify client income, without burdening clients from low-income families. Recipients that have lawful access to other valid means of income verification because of the client’s participation in another program may use those data rather than re-verify income or rely solely on clients’ self-report. If a client’s income cannot be verified after reasonable attempts to do so, charges are to be based on the client’s self-reported income. (10) If a third party (including a Government agency) is authorized or legally obligated to pay for services, all reasonable efforts must be made to obtain the third-party payment without application of any discounts. Where the cost of services is to be reimbursed VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 under title XIX, XX, or XXI of the Social Security Act, a written agreement with the title XIX, XX, or XXI agency is required. (11)(i) Provide that if an application relates to consolidation of service areas or health resources or would otherwise affect the operations of local or regional entities, the applicant must document that these entities have been given, to the maximum feasible extent, an opportunity to participate in the development of the application. Local and regional entities include existing or potential subrecipients which have previously provided or propose to provide family planning services to the area proposed to be served by the applicant. (ii) Provide an opportunity for maximum participation by existing or potential subrecipients in the ongoing policy decision making of the project. (b) In addition to the requirements of paragraph (a) of this section, each project must meet each of the following requirements unless the Secretary determines that the project has established good cause for its omission. Each project must: (1) Provide for medical services related to family planning (including consultation by a clinical services provider, examination, prescription and continuing supervision, laboratory examination, contraceptive supplies), in person or via telehealth, and necessary referral to other medical facilities when medically indicated, and provide for the effective usage of contraceptive devices and practices. (2) Provide for social services related to family planning, including counseling, referral to and from other social and medical service agencies, and any ancillary services which may be necessary to facilitate clinic attendance. (3) Provide for opportunities for community education, participation, and engagement to: (i) Achieve community understanding of the objectives of the program; (ii) Inform the community of the availability of services; and (iii) Promote continued participation in the project by diverse persons to whom family planning services may be beneficial to ensure access to equitable, affordable, client-centered, quality family planning services. (4) Provide for orientation and inservice training for all project personnel. (5) Provide services without the imposition of any durational residency requirement or requirement that the patient be referred by a physician. (6) Provide that family planning medical services will be performed under the direction of a clinical services PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 56179 provider, with services offered within their scope of practice and allowable under state law, and with special training or experience in family planning. (7) Provide that all services purchased for project participants will be authorized by the project director or their designee on the project staff. (8) Provide for coordination and use of referrals and linkages with primary healthcare providers, other providers of healthcare services, local health and welfare departments, hospitals, voluntary agencies, and health services projects supported by other federal programs, who are in close physical proximity to the Title X site, when feasible, in order to promote access to services and provide a seamless continuum of care. (9) Provide that if family planning services are provided by contract or other similar arrangements with actual providers of services, services will be provided in accordance with a plan which establishes rates and method of payment for medical care. These payments must be made under agreements with a schedule of rates and payment procedures maintained by the recipient. The recipient must be prepared to substantiate that these rates are reasonable and necessary. (10) Provide, to the maximum feasible extent, an opportunity for participation in the development, implementation, and evaluation of the project by persons broadly representative of all significant elements of the population to be served, and by others in the community knowledgeable about the community’s needs for family planning services. § 59.6 What procedures apply to assure the suitability of informational and educational material (print and electronic)? (a) A grant under this section may be made only upon assurance satisfactory to the Secretary that the project shall provide for the review and approval of informational and educational materials (print and electronic) developed or made available under the project by an Advisory Committee prior to their distribution, to assure that the materials are suitable for the population or community to which they are to be made available and the purposes of Title X of the Act. The project shall not disseminate any such materials which are not approved by the Advisory Committee. (b) The Advisory Committee referred to in paragraph (a) of this section shall be established as follows: (1) Size. The committee shall consist of no fewer than five members and up to as many members the recipient E:\FR\FM\07OCR3.SGM 07OCR3 56180 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations determines, except that this provision may be waived by the Secretary for good cause shown. (2) Composition. The committee shall include individuals broadly representative of the population or community for which the materials are intended (in terms of demographic factors such as race, ethnicity, color, national origin, disability, sex, sexual orientation, gender identity, sex characteristics, age, marital status, income, geography, and including but not limited to individuals who belong to underserved communities, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality). (3) Function. In reviewing materials, the Advisory Committee shall: (i) Consider the educational, cultural, and diverse backgrounds of individuals to whom the materials are addressed; (ii) Consider the standards of the population or community to be served with respect to such materials; (iii) Review the content of the material to assure that the information is factually correct, medically accurate, culturally and linguistically appropriate, inclusive, and trauma informed; (iv) Determine whether the material is suitable for the population or community to which is to be made available; and (v) Establish a written record of its determinations. lotter on DSK11XQN23PROD with RULES3 § 59.7 What criteria will the Department of Health and Human Services use to decide which family planning services projects to fund and in what amount? (a) Within the limits of funds available for these purposes, the Secretary may award grants for the establishment and operation of those projects which will in the Department’s judgment best promote the purposes of section 1001 of the Act, taking into account: (1) The number of clients, and, in particular, the number of low-income clients to be served; (2) The extent to which family planning services are needed locally; VerDate Sep<11>2014 22:06 Oct 06, 2021 Jkt 256001 (3) The ability of the applicant to advance health equity; (4) The relative need of the applicant; (5) The capacity of the applicant to make rapid and effective use of the federal assistance; (6) The adequacy of the applicant’s facilities and staff; (7) The relative availability of nonfederal resources within the community to be served and the degree to which those resources are committed to the project; and (8) The degree to which the project plan adequately provides for the requirements set forth in these regulations. (b) The Secretary shall determine the amount of any award on the basis of an estimate of the sum necessary for the performance of the project. No grant may be made for less than 90 percent of the project’s costs, as so estimated, unless the grant is to be made for a project which was supported, under section 1001, for less than 90 percent of its costs in fiscal year 1975. In that case, the grant shall not be for less than the percentage of costs covered by the grant in fiscal year 1975. (c) No grant may be made for an amount equal to 100 percent for the project’s estimated costs. § 59.8 How is a grant awarded? (a) The notice of grant award specifies how long HHS intends to support the project without requiring the project to recompete for funds. This anticipated period will usually be for three to five years. (b) Generally, the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A recipient must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the recipient’s progress and management practices and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government. (c) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved PO 00000 Frm 00038 Fmt 4701 Sfmt 9990 application or portion of an approved application. § 59.9 For what purpose may grant funds be used? Any funds granted under this subpart shall be expended solely for the purpose for which the funds were granted in accordance with the approved application and budget, the regulations of this subpart, the terms and conditions of the award, and the applicable cost principles prescribed in 45 CFR part 75. § 59.10 Confidentiality. (a) All information as to personal facts and circumstances obtained by the project staff about individuals receiving services must be held confidential and must not be disclosed without the individual’s 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.3 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. § 59.11 Additional conditions. The Secretary may, with respect to any grant, impose additional conditions prior to, at the time of, or during any award, when in the Department’s judgment these conditions are necessary to assure or protect advancement of the approved program, the interests of public health, or the proper use of grant funds. [FR Doc. 2021–21542 Filed 10–4–21; 4:15 pm] BILLING CODE 4150–30–P 3 42 E:\FR\FM\07OCR3.SGM U.S.C. 300(a). 07OCR3

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Rules and Regulations]
[Pages 56144-56180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21542]



[[Page 56143]]

Vol. 86

Thursday,

No. 192

October 7, 2021

Part IV





Department of Health and Human Services





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42 CFR Part 59





Ensuring Access to Equitable, Affordable, Client-Centered, Quality 
Family Planning Services; Final Rule

Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / 
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 59

RIN 0937-AA11


Ensuring Access to Equitable, Affordable, Client-Centered, 
Quality Family Planning Services

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services (HHS).

ACTION: Final rule.

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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. 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 November 8, 2021.

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 SW, Washington, DC 
20201; email: [email protected].

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 
59.2, 59.5(a)(1), 59.5(a)(3), 59.5(a)(8), 59.5(a)(9), 59.5(a)(12), 
59.5(a)(13), 59.5(b)(1), 59.5(b)(3), 59.5(b)(8), 59.6, 59.7, 59.10, and 
59.11. Technical corrections were proposed to 59.2, 59.5(a)(4), 
59.5(a)(5), 59.5(a)(6), 59.5(a)(7), 59.5(a)(11), 59.5(b)(3), 
59.6(b)(2), 59.8, and 59.12. HHS received comments on all of the 
revisions proposed in the NPRM, except the revision to 59.11. In 
addition, the Department received comments on three of the 10 technical 
corrections, including the technical corrections to 59.5(a)(4), 
59.5(a)(5), and 59.12.
    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. This includes the revisions to 
59.5(a)(3), 59.5(a)(8), 59.5(a)(9), 59.5(b)(3), 59.5(b)(8), 59.6, 59.7, 
and 59.11. This also includes the technical corrections to 59.2, 
59.5(a)(4), 59.5(a)(5), 59.5(a)(6), 59.5(a)(7), 59.5(a)(11), 
59.5(b)(3), 59.6(b)(2), and 59.8. 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 (59.2, 59.5(a)(1), 59.5(b)(1), and 59.10); (b) additional 
modifications to one of the provisions with a technical correction in 
the NPRM (59.5(a)(4)); (c) removal of three of the revised provisions 
in the NPRM (59.5(a)(12), 59.5(a)(13), and 59.12); and (d) revisions to 
one provision not originally proposed for revision in the NPRM 
(59.5(b)(6)). The six additional technical corrections include minor 
clarifications to 59.2, 59.5(a)(1), 59.5(a)(4), and 59.6 and two 
technical corrections to 59.5(b)(7) and 59.7 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; 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 U.S.C. 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).

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 U.S.C. 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. Sec.  59.2. Definitions
    B. Sec.  59.5(a)(1). Broad Range of Acceptable and Effective 
Medically Approved Family Planning Methods and Services
    C. Sec.  59.5(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
    D. Sec.  59.5(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. Sec.  59.5(a)(8). Charges for Services With a Schedule of 
Discounts
    F. Sec.  59.5(a)(9). Reasonable Measures To Verify Client Income
    G. Sec.  59.5(a)(12). State Reporting Laws

[[Page 56145]]

    H. Sec.  59.5(a)(13). Subrecipient Monitoring
    I. Sec.  59.5(b)(1) Provide Medical Services Related to Family 
Planning
    J. Sec.  59.5(b)(3) Community Education, Participation, and 
Engagement
    K. Sec.  59.5(b)(6) Services Under Direction of Clinical 
Services Provider
    L. Sec.  59.5(b)(8) Coordination and Use of Referrals and 
Linkages
    M. Sec.  59.6 Suitability of Informational and Educational 
Material
    N. Sec.  59.7 Grant Review Criteria
    O. Sec.  59.10. Confidentiality
    P. Sec.  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 abortion-related activities were permissible under the 
program, given Title X's statutory prohibition on abortion services. 
That statutory prohibition, section 1008 (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 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 X-funded entities from 
referring for abortion, while requiring referral for prenatal care, 
regardless of a client's request, and (5) required providers to 
maintain detailed records on adolescent 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 program's 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 grantees--and 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/HARD-HRD-82-106 (1982), at 14-15; 65 FR 
41270, 41272 (July 3, 2000). While those forty-year-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. Experience under the 2019 rule has only underscored these 
concerns. Based on that experience--which was not and could not have 
been available to the Department at the time the 2019 rule was 
promulgated--we 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 Department's 2019 rule arbitrary and 
capricious. Mayor of Baltimore v. Azar, 973 F.3d 258 (4th Cir. 2020). 
The Fourth

[[Page 56146]]

Circuit also held that the 2019 rule violated an annual appropriations 
rider requiring nondirective counseling, the non-directive mandate.\1\
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    \1\ Both circuit courts also differed on the permissibility of 
the rule under section 1554 of the Affordable Care Act.
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    Losing parties in both cases sought review from the Supreme Court 
in October of 2020. The Court granted certiorari on February 22, 2021, 
consolidating the cases. No. 20-429. On March 12, 2021, the parties 
stipulated to dismiss the cases under Supreme Court Rule 46.1.
    While courts and judges were split on the ultimate legality of the 
2019 rule, evidence of the negative public health consequences of the 
rule quickly became clear, and significant. After the implementation of 
the 2019 rule, 19 Title X grantees out of 90 total grantees withdrew 
from the program. The 19 grantees that withdrew from the Title X 
program included 11 State Departments of Health and independent Family 
Planning Associations and eight Planned Parenthood organizations.\2\
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    \2\ Withdrawn grantees included (1) Family Planning Association 
of Maine, Inc., (2) Hawaii Department of Health, (3) Health 
Imperatives, Inc. (MA), (4) Illinois Department of Health, (5) 
Maryland Department of Health, (6) Massachusetts Department of 
Public Health, (7) Oregon Health Authority, (8) Planned Parenthood 
Association of Utah, (9) Planned Parenthood Minnesota, North Dakota, 
South Dakota, (10 & 11) Planned Parenthood of Great Northwest & the 
Hawaiian Islands (two separate grants), (12) Planned Parenthood of 
Greater Ohio, (13) Planned Parenthood of Illinois, (14) Planned 
Parenthood of Northern New England, (15) Planned Parenthood of 
Southern New England, (16) Public Health Solutions (NY), (17) New 
York Department of Health, (18) Vermont Agency of Human Services, 
and (19) Washington State Department of Health.
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    These organizations made clear to the Department in formal 
correspondence that they relinquished their grants out of concern that 
the 2019 rule interfered with the patient-provider relationship and 
compromised their ability to provide quality healthcare to all clients. 
One organization commented that ``the Final Rule makes it impossible 
for us to provide healthcare and information to patients consistent 
with medical ethics and evidence-based standards of care.'' Another 
organization stated that the 2019 rule ``would fundamentally compromise 
the relationship our patients have with us as trusted providers of this 
most personal and private healthcare.'' Another organization said that 
``the new regulations interfere with a healthcare provider's ability to 
provide healthcare in accordance with accepted standards of care for 
reproductive health.'' Still another said, ``these new rules require 
our providers to deprive their patients of the information and services 
they need to make and carry out fully informed decisions about their 
reproductive health. Our providers' ethical and professional 
responsibilities do not allow this.'' Although it might have been 
possible, at the time the 2019 rule was promulgated, to predict that 
providers would withdraw, any such prediction would have been 
uncertain. That so many providers did in fact withdraw from the program 
is a change in circumstances that, in the Department's view, demands 
reconsideration of the 2019 rule.
    In addition to the grantees that withdrew from Title X completely, 
many other grantees that continued to receive Title X funding had 
subrecipients and service sites within their existing networks withdraw 
from the program. Overall, 19 grantees, including 231 subrecipients and 
945 service sites, withdrew from the Title X program shortly after the 
rule took effect. Additionally, 18 grantees that continued in the 
program reported losses to their service network (i.e., exiting 
subrecipients) because of the 2019 final rule. As a result, the Title X 
program provided services to 844,083 fewer clients in 2019 compared to 
2018.\3\ Comparing Family Planning Annual Report (FPAR) data for 2018 
and 2019, OPA estimates that 94% (or 789,960) of the total decrease 
(844,083) in clients can be attributed to the 2019 rule. A total of 41 
states and two territories saw a decrease in clients served in 2019 
compared to 2018. Of those, seven saw a decline of more than 40 percent 
in clients served (AK, HI, MD, UT, VT, WI, and WV), seven saw a decline 
of 31-40 percent (CA, CT, ME, MN, NH, NM, and NY), seven saw a decline 
of 21-30 percent (AZ, IL, MA, MT, NJ, OR, and WA), seven saw a decline 
of 11-20 percent (IA, IN, MI, OH, PA, VA, and the Marshall Islands), 
nine saw a decline of 5-10 percent (AL, AR, KY, NE, NC, ND, SC, TN, and 
WY), and six saw a decline of five percent or less (DE, CO, LA, OK, SD, 
and the U.S. Virgin Islands). Only nine states, six territories and the 
District of Columbia saw their number of clients served stay the same 
(FL, KS, MO, RI, and TX) between 2018 and 2019 (1%) or 
increase (GA, ID, MS, NV, six territories, and DC), with the majority 
experiencing a small annual increase of between 70 to 3,000 clients. 
Minor fluctuations notwithstanding, 789,960 fewer clients were served, 
which had a disproportionate impact on minority clients, adolescent 
clients, lower-income individuals, and those without insurance--all 
outcomes directly attributable to the 2019 rule. Most concerningly, 
there are six states that formerly had Title X services that currently 
have no Title X services available (HI, ME, OR, UT, VT, and WA) and 
seven states with Title X services available on a very limited basis 
(AK, CT, IL, MA, MN, NH, and NY). The Department believes that these 
stark facts, which became clear only after the promulgation of the 2019 
rule, justify reconsideration of that rule.
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    \3\ (OPA, 2020). Family Planning Annual Report: 2019 National 
Summary Report. Accessed on March 9, 2021 from https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf.
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    To ensure continuity of services and maintain a safe environment 
for clients and staff during the pandemic, Title X providers followed 
guidance issued by the Centers for Disease Control and Prevention 
(CDC), OPA, and others to manage supply and staffing shortages, and 
they implemented creative strategies tailored to their circumstances 
and clientele (virtual telehealth, for example). Despite these efforts, 
in 2020 vs. 2019, Title X had 193 fewer subrecipients (867 vs. 1,060) 
and 794 fewer service sites (3,031 vs. 3,825). The decrease in the size 
of the Title X service network appears to have substantially reduced 
the availability of and, consequently, access to Title X services. In 
2020, Title X served 1.6 million fewer family planning users than in 
2019 (1.5 million vs. 3.1 million), and Title X service sites delivered 
care to 302 fewer users per site (507 vs. 809). Furthermore, in 2020, 
Title X conducted almost 2.0 million fewer family planning encounters 
than in 2019 (2.7 million vs. 4.7 million). While the 2020 data 
undoubtedly reflect the public health emergency related to the COVID-19 
pandemic, the pattern of the losses in the program initiated by the 
2019 rule was exacerbated in 2020 for an already disrupted and weakened 
network.
    Of additional concern, the 2019 rule has had a disproportionate 
impact on low-income clients, who are precisely the population that the 
Title X program was established to serve. The 2019 rule has 
significantly decreased the number of low-income, uninsured, and racial 
and ethnic minorities accessing Title X services. Following 
implementation of the 2019 rule, 573,650 fewer clients under 100 
percent of the federal poverty level (FPL); 139,801 fewer clients 
between 101 percent FPL to 150 percent FPL; 65,735 fewer clients 
between 151 percent FPL and 200 percent FPL; and 30,194 fewer clients 
between 201 percent FPL to 250 percent FPL received Title X services. 
This contradicts the purpose and intent of the Title X program, which 
is to prioritize and

[[Page 56147]]

increase family planning services to low-income clients. Additionally, 
324,776 fewer uninsured clients were served in 2019 compared to 2018. 
FPAR data also demonstrate that in 2019 compared to 2018, 128,882 fewer 
Black or African Americans; 50,039 fewer Asians; 6,724 fewer American 
Indians/Alaska Natives; 7,218 fewer Native Hawaiians/Pacific Islanders; 
and 269,569 fewer Hispanics/Latinos received Title X services.\4\ 
Additionally, 151,375 fewer adolescent clients received essential 
family planning services in 2019. The Department believes these new 
facts warrant a reconsideration of the 2019 rule.
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    \4\ (OPA, 2020). Family Planning Annual Report: 2019 National 
Summary Report. Accessed on March 9, 2021 from https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf.
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    The mandate of the Title X program is to support access to critical 
family planning and preventive health services; unfortunately, the 
result of the 2019 rule ran counter to that effort. The 2019 rule 
undermined the mission of the Title X program by helping fewer 
individuals in planning and spacing births, providing fewer preventive 
health services, and delivering fewer screenings for sexually 
transmitted infections (STIs). More specifically, in 2019 compared to 
2018, 225,688 fewer clients received oral contraceptives; 49,803 fewer 
clients received hormonal implants; and 86,008 fewer clients received 
intrauterine devices (IUDs). Additionally, 90,386 and 188,920 fewer 
Papanicolaou (Pap) tests and clinical breast exams, respectively, were 
performed in 2019 compared to 2018. Confidential human immunodeficiency 
virus (HIV) tests decreased by 276,109. STI testing decreased by 
256,523 for chlamydia, by 625,802 for gonorrhea, and by 77,524 for 
syphilis. Furthermore, 71,145 fewer individuals who were pregnant or 
sought pregnancy were served.\5\
---------------------------------------------------------------------------

    \5\ (OPA, 2020). Family Planning Annual Report: 2019 National 
Summary Report. Accessed on March 9, 2021 from https://opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-summary.pdf.
---------------------------------------------------------------------------

    In the 2019 rule, the Department stated that the rule was 
``expected to increase the number of entities interested in 
participating in Title X as grantees or subrecipient service providers 
and, thereby, to increase patient access to family planning services 
focused on optimal health outcomes for every Title X client.'' 84 FR at 
7782 (March 24, 2019). However, this expectation proved unwarranted. 
Despite several attempts, OPA has been unable to recruit new grantees 
and new providers into the Title X program to fill the current gaps in 
services resulting from implementation of the 2019 rule. First, OPA 
issued competitive supplemental funding of $33.7 million to 50 existing 
Title X grantees in fiscal year 2019 to expand their Title X services. 
Unfortunately, even with the additional funding, the majority of states 
were not able to increase the number of service sites in their Title X 
networks. From 2018 to 2020, 38 states and territories saw a decrease 
in the number of service sites in their networks, 12 saw no change in 
their number of service sites, and only nine saw an increase in the 
number of service sites. Analyzing users between 2018-2020 for those 
nine states that gained service sites, six still lost users (WV, AZ, 
DE, NE, CO, and TX) while three gained users (GA, NV, and Palau). Next, 
OPA issued a competitive funding announcement in fiscal year 2020 to 
recruit new grantees to provide Title X services in unserved or 
underserved states and communities. The number of applications received 
was so low (eight eligible applications received) that the resulting 
grant awards were for less than the total amount of funding available 
(grant awards for $8.5 million with $20 million available), and OPA was 
only able to fund grantees to provide services in three states with no 
or limited Title X services at the time.
    The lack of organizations applying for Title X grant funding 
following implementation of the 2019 rule and the lack of new service 
sites willing to join existing Title X grantees as providers strongly 
suggest that the Department was wrong to believe that the 2019 rule 
would increase the number of grantees and providers. Rather, the 2019 
rule appears to have had the opposite effect and resulted in a 
significant loss of grantees, subrecipients, and service sites, and 
close to one million fewer clients served from 2018 to 2019. The 
Department believes that this record warrants a change in course.
    The decline in clients served and services provided is devastating. 
The Title X program is the only federal grant program dedicated to 
providing comprehensive family planning and related preventive health 
services. Title X clinics provide services to clients, with priority 
given to persons from low-income families. Title X services are 
voluntary, confidential, and provided regardless of one's ability to 
pay. For many clients, Title X clinics are their only ongoing source of 
healthcare and health education. In fact, six in 10 women who go to a 
publicly funded family planning clinic consider it their usual source 
of medical care.\6\
---------------------------------------------------------------------------

    \6\ Frost, J., Gold., Hasstedt, K., & Sonfield, A. (2014). 
Moving Forward: Family Planning in the Era of Health Reform. New 
York: Guttmacher Institute.
---------------------------------------------------------------------------

    While some family planning providers that withdrew from the Title X 
program were able to continue providing reproductive health services at 
some level in the absence of Title X funding, the services provided 
were not the same as those provided under Title X. Grantees that 
relinquished their Title X funding at the time made clear that they 
were not able to provide the same breadth of services as they had been 
able to under Title X and were not able to provide services using the 
same schedule of discounts as required in the Title X program. 
According to several comments received, the loss of Title X funding 
meant that organizations had to adjust their fee schedules and push 
more costs for services to the clients. As a result, organizations saw 
more clients forgoing recommended tests, lab work, STI testing, 
clinical breast exams, and pap tests. Further, due to costs, 
organizations saw some family planning clients outside of the Title X 
network choose less effective methods of birth control.
    The 2019 rule abandoned major portions of Providing Quality Family 
Planning Services: Recommendations from Centers for Disease Control and 
Prevention and the U.S. Office of Population Affairs (QFP),\7\ such as 
nondirective options counseling and referrals, and the client-centered 
approach recommended by QFP, over the objection of every major medical 
organization and without any countervailing public health rationale. 
QFP recommendations support providers in delivering quality family 
planning services and define family planning services within a broad 
context of preventive services, to improve health outcomes for 
individuals and their (future) children. QFP recommendations are based 
on a rigorous, systematic, and transparent review of the evidence and 
were developed with input from a broad range of clinical experts, OPA, 
and the CDC. These recommendations not only improve the quality of care 
provided to family planning clients, but they foster a supportive and 
communicative relationship between provider and patient. As evident 
from grantee relinquishment letters and comments

[[Page 56148]]

received in response to the 2021 NPRM, abandoning major portions of 
this approach has damaged the patient-provider relationship. Moreover, 
the 2019 rule required prenatal referral even if the patient objected, 
an approach which also does not comport with well-accepted public 
health and clinical care principles.
---------------------------------------------------------------------------

    \7\ CDC. (2014). Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs. 
Accessed on March 8, 2021 from https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning.
---------------------------------------------------------------------------

    On January 28, 2021, President Biden issued a ``Memorandum on 
Protecting Women's Health at Home and Abroad.'' \8\ The Memorandum 
stated that ``[w]omen should have access to the healthcare they need. 
For too many women today, both at home and abroad, that is not 
possible. Undue restrictions on the use of Federal funds have made it 
harder for women to obtain necessary healthcare. The Federal Government 
must take action to ensure that women at home and around the world are 
able to access complete medical information, including with respect to 
their reproductive health.'' The Memorandum then instructed the 
Department to ``review the Title X Rule and any other regulations 
governing the Title X program that impose undue restrictions on the use 
of Federal funds or women's access to complete medical information and 
shall consider, as soon as practicable, whether to suspend, revise, or 
rescind, or publish for notice and comment proposed rules suspending, 
revising, or rescinding, those regulations, consistent with applicable 
law, including the Administrative Procedure Act.''
---------------------------------------------------------------------------

    \8\ Available at https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/28/memorandum-on-protecting-womens-health-at-home-and-abroad/.
---------------------------------------------------------------------------

    HHS reviewed the 2019 regulations pursuant to the President's 
memorandum. Following this review, on April 15, 2021, the Department 
issued a Notice of Proposed Rulemaking (NPRM) for public comment (86 FR 
19812, April 15, 2021), proposing rules to revise the 2019 regulation 
by essentially readopting the 2000 regulations. 65 FR 41270 (July 3, 
2000). The 2000 regulations were consistent with applicable statutory 
commands, were widely accepted by grantees, enabled the Title X program 
to operate successfully, and led to no litigation over their 
permissibility.
    Based on the evidence that has emerged since the adoption of the 
2019 rule, as well as a fresh consideration of the evidence that 
existed at the time, the negative public health consequences of the 
2019 rule are clear. The rule dramatically reduced access to family 
planning and preventive health services that are essential for hundreds 
of thousands of clients, especially for the low-income clients Title X 
was specifically created to serve. The 2019 rule decreased the number 
of providers willing to participate in the Title X program, further 
reducing access to family planning services within states across the 
country and in rural and urban communities alike. The 2019 rule shifted 
the Title X program away from its history of providing client-centered 
quality family planning services and instead set limits on the patient-
provider 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. 
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 and other disproportionately impacted 
communities, such as those in rural regions, minority clients, and 
adolescent clients, are relegated to inferior access. The populations 
served by Title X may already face health inequities driven by 
financial and access barriers to quality care that would be exacerbated 
by continuing to allow limited or delayed healthcare choices and biased 
or insufficient healthcare information. Given that so many individuals 
depend on the Title X program as their primary source of healthcare, 
the Department recognizes that this is a situation that must be 
rectified with urgency in the interest of public health and equity.
    Most importantly, in readopting the 2000 rule, this final rule 
removes the strict physical separation requirements that were imposed 
on top of existing obligations for separation between abortion services 
and Title X project related activities. It also allows Title X 
providers to provide truly nondirective counseling and refer their 
patients for all services desired by the client, including abortion 
services. The 2000 regulations successfully governed the Title X 
program for decades and were widely accepted by grantees.
    The 2019 rule imposed an interrelated set of requirements that are 
difficult to disentangle provision by provision. For example, 
59.5(a)(5) prohibited funded projects from providing, promoting, 
referring, or supporting abortion as a method of family planning. 
Section 59.13 concurrently required assurance that a project did not 
``include abortion as a method of family planning'' backed by 
documentary evidence of Subsections 59.14-59.16. The interrelatedness 
of these requirements was underscored by 59.7(b) requiring applicants 
to ``clearly address how the proposal will satisfy the requirements of 
the regulation,'' before even proceeding to competitive consideration. 
Most of the 2019 provisions did not function independently of each 
other.
    The Department did initially propose keeping portions of two 
provisions from the 2019 rule regarding compliance reporting 
(59.5(a)(12)) on state sexual abuse notification laws and subrecipient 
monitoring (59.5(a)(13)). As further explained below, these provisions 
created administrative costs for grantees and the government with no 
measurable benefits. These provisions, like the entire 2019 rule, 
depended on assumptions about how the program should work and grantee 
compliance even with no evidence of grantee non-compliance.
    Given these considerations, the Department has determined that the 
most appropriate course is to revoke the 2019 rule in its totality. 
Every court to rule on the 2019 rule also believed that all of its 
provisions were of a piece and either struck down or upheld the rule in 
its entirety. See, e.g., Mayor of Baltimore v. Azar, 973 F3d 258, 292 
(4th Cir. 2020) (``Despite the severability clause, the Final Rule is 
not severable because it is clear HHS `intended the [Final Rule] to 
stand or fall as a whole,' and the agency desired `a single, coherent 
policy, the predominant purpose of which' is to reinstitute the 1988 
Rule.'').
    As compared to the 2019 rule, new provisions added to the re-
adoption of the 2000 rule operate independently of each other--and the 
2000 rule--to enhance the program. Particularly as the program operated 
for decades under the 2000 rule, the 2021 additions are severable from 
the 2000 rule. For example, while adding to the statutory goals of 
reaching low-income and underserved individuals, if the added grant 
evaluation criteria of equity, 59.7(a)(3), was excised, the program 
could still accomplish its mission successfully using the 2000 criteria 
alone. And, were a court to strike down the new income verification 
measures in 59.5(a)(9), the program would be able to accomplish its 
mission using the 2000 criteria alone.
    In addition to readopting the requirements as they existed prior to 
the 2019 rule, the 2021 rule also includes several revisions that will 
strengthen the Title X program and ensure access to equitable, 
affordable, client-centered, quality family planning services for all 
clients, especially for low-income clients, while retaining the 
longstanding prohibition on directly promoting or performing abortion 
that follows from

[[Page 56149]]

Section 1008's text and subsequent appropriations enactments.
    Advancing equity for all, including people from low-income 
families, people of color, and others who have been historically 
underserved, marginalized, and adversely affected by persistent poverty 
and inequality, is a priority for the Department, for OPA, and for the 
Title X program. By focusing on advancing equity in the Title X 
program, we can create opportunities to support communities that have 
been historically underserved, which benefits everyone. The 2021 rule 
was written to ensure that the predominantly low-income clients who 
rely on Title X services as their usual source of medical care have 
access to the same quality healthcare, including full medical 
information and referrals, that higher-income clients and clients with 
private insurance are able to access. Key strategies for advancing 
equity include removing barriers to accessing services, improving the 
quality of services, and providing services that are client-centered. 
Several revisions in the rule focus on improving access to services. 
These revisions include clearly defining what constitutes a broad range 
of acceptable and effective family planning methods and services, 
requiring service sites not offering a broad range of methods on-site 
to provide a prescription to the client for their method of choice or 
referrals, as requested, clarifying required billing practices and 
income verification for low-income clients, enabling a broader range of 
clinical services providers to direct Title X services and to provide 
consultation for medical services, and strengthening client 
confidentiality.
    Several revisions in the 2021 rule focus on improving quality of 
Title X services. These revisions include clearly defining quality 
healthcare as safe, effective, client-centered, timely, efficient, and 
equitable; incorporating QFP's definition of family planning into the 
regulation; and requiring all family planning services to be delivered 
consistent with nationally recognized standards of care. Finally, 
several revisions in the 2021 rule focus on ensuring client-centered 
care. These revisions include clearly defining client-centered care as 
being respectful of, and responsive to, individual client preferences, 
needs, and values and where client values guide all clinical decisions, 
and requiring all family planning services to be client-centered, 
culturally and linguistically appropriate, inclusive, and trauma-
informed.

II. Public Comment and Departmental Response

    The Department provided a 30-day public comment period for the 
proposed rule. That period closed on May 17, 2021. A total of 180,266 
public comments were submitted to www.Regulations.gov or directly to 
the Department.
    With this 2021 final rule, the Department revokes the requirements 
of the 2019 regulations (84 FR 7714, March 24, 2019) and readopts the 
2000 regulations (65 FR 41270, July 3, 2000) with several revisions. In 
the section below, the Department discusses the public comments, its 
responses, and the text of the final rules. The Department first 
presents a summary of public comments received related to revoking the 
2019 regulation and readopting the 2000 regulation. The Department then 
provides a summary of comments received regarding the revisions and 
technical corrections proposed in the NPRM to specific provisions of 
the 2000 regulations. The NPRM proposed 14 revisions, including to 
59.2, 59.5(a)(1), 59.5(a)(3), 59.5(a)(8), 59.5(a)(9), 59.5(a)(12), 
59.5(a)(13), 59.5(b)(1), 59.5(b)(3), 59.5(b)(8), 59.6, 59.7, 59.10, and 
59.11. The NPRM also proposed 10 technical corrections, including to 
59.2, 59.5(a)(4), 59.5(a)(5), 59.5(a)(6), 59.5(a)(7), 59.5(a)(11), 
59.5(b)(3), 59.6(b)(2), 59.8, and 59.12. The Department received 
comments on all the revisions proposed in the NPRM and three of the 10 
technical corrections. The Department did not receive comments on the 
revision to 59.11, nor to the technical corrections to 59.2, 
59.5(a)(6), 59.5(a)(7), 59.5(a)(11), 59.5(b)(2), 59.5(b)(3), or 59.8. A 
summary of comments and the Department's response are only provided for 
those revisions and technical corrections that received comments. In 
addition, the Department received public comments requesting a revision 
to 59.5(b)(6) that was not proposed in the NPRM, but that is related to 
the revision that was proposed in the NPRM to 59.5(b)(1). A summary of 
these comments and the Department's response are also included below.
    After considering the comments, the Department adopts the 
regulations proposed for public comment on April 15, 2021 at 86 FR 
19812 with nine additional revisions and six additional technical 
corrections to what was proposed in the NPRM.
General Comments Related To Revoking 2019 Regulations and Readopting 
the 2000 Regulations

A. Compliance With Section 1008 (42 U.S.C. 300a-6)

    Comments: Thousands of comments expressed concern that the 
program's returning to the 2000 regulations violated both the Title X 
statute and the Court's holding in Rust v. Sullivan, 500 U.S. 173 
(1991). Many comments stated referral for abortion ``squarely'' 
violated the ``plain'' ``clear'' text of section 1008. Many of these 
same comments also asserted the statute requires separation from 
abortion activities because they are programs ``where'' abortion is a 
method of family planning. Both comments believing the 2000 rule to be 
unlawful, and those affirming it to be lawful, cited Rust as well as 
legislative history in making their arguments.
    Those opposing the proposed rule also stressed that private 
organizations have no right to federal funding, much less to federal 
funding to perform abortions. These comments stated that ``[m]oney is 
fungible,'' and reverting to the 2000 rule will create so-called 
``slush funds'' and infrastructure for organizations to perform 
abortions in violation of section 1008. They also suggested that the 
2000 rule lacked any mechanism to ensure compliance with the statute, 
and that the NPRM, in fact, violates the statute because the proposed 
definition of ``family planning'' includes related ``pregnancy 
counseling'' which requires referral for abortion when requested 
(59.5(a)(5)). Many comments asserted that revoking the 2019 rule would 
allow grantees to engage in lobbying and other activities encouraging 
abortion that violate section 1008.
    Response: As stated in the NPRM, the Supreme Court held in Rust: 
``[W]e agree with every court to have addressed the issue that the 
language is ambiguous. The language of Sec.  1008--that `none of the 
funds appropriated under this subchapter shall be used in programs 
where abortion is a method of family planning'--does not speak directly 
to the issues of counseling, referral, advocacy, or program 
integrity.'' Rust at 184. No court adjudicating the 2019 rule found 
that the separation, referral, or other requirements were required by 
Rust. Such a finding would be contrary to the primary holding in Rust. 
Counseling for abortion, including referral when requested, has never 
been held to constitute a violation of section 1008.
    Interpreting section 1008 to prohibit referrals and require strict 
separation would also be inconsistent with nearly

[[Page 56150]]

40 years of agency practice under the program across numerous 
administrations. Such an interpretation would also appear contrary to 
decades of close Congressional oversight, including annual Title X 
appropriations riders, and a specific annual line item appropriation 
through which Congress can be--and has been--quite clear as to how the 
agency should operate.
    In readopting the 2000 rule, the program is also reinstating 
interpretations and policies under section 1008 of the statute that 
were in place for much of the program's history and published in the 
Federal Register in 2000. 65 FR 41281 (July 3, 2000). Those program 
policies discuss, for example, the requirements for separation: 
``Separation of Title X from abortion activities does not require 
separate grantees or even a separate health facility, but separate 
bookkeeping entries alone will not satisfy the spirit of the law. Mere 
technical allocation of funds, attributing federal dollars to non-
abortion activities, is not a legally supportable avoidance of section 
1008.'' 65 FR at 41282 (July 3, 2000). Also, ``[w]hile a Title X 
project may provide a referral for abortion, which may include 
providing a patient with the name, address, telephone number, and other 
relevant factual information (such as whether the provider accepts 
Medicaid, charges, etc.) about an abortion provider, the project may 
not take further affirmative action (such as negotiating a fee 
reduction, making an appointment, providing transportation) to secure 
abortion services for the patient.'' 65 FR at 41281 (July 3, 2000). 
Finally, while a Title X project may not advocate for abortion as a 
method of family planning, it ``may be a dues paying participant in a 
national abortion advocacy organization, so long as there are other 
legitimate program-related reasons for the affiliation (such as access 
to certain information or data useful to the Title X project).'' Id. 
Interested entities are encouraged to consult this notice.
    The Department agrees that it is not under a duty to subsidize 
abortion. It does not do so, and it is prohibited from doing so. As 
discussed in the NPRM, legislative history and longstanding 
appropriations riders prohibit Title X funds from being expended on 
abortion. See, e.g., Consolidated Appropriations Act, 2021, Public Law 
116-260, Div. H, sec. 207, 134 Stat. 1182, 1590. More generally, 
Section 507 of the Consolidated Appropriations Act, 2021 prohibits 
federal funds from being used for abortion except for cases of rape, 
incest, or maternal health. Id. at sec. 507. As discussed in the NPRM 
and above, the Department employs a variety of mechanisms to enforce 
such restrictions, such as regular grant reports, compliance monitoring 
visits, third-party audits, compliance guidance, and grantee education. 
None of these oversight tools have uncovered any more than minimal 
problems with grantee compliance under section 1008.
    The Department also agrees that no particular private organizations 
have a right to Title X funding. The program is returning to the 
program requirements in operation for the majority of its history 
because those requirements best serve individual clients and the public 
health. In the wake of the 2019 rule, both private organizations and 
states withdrew from the program, leaving multiple states without any 
Title X providers and the agency struggling to meet its mandate to 
provide family planning services for low-income populations in areas of 
high need. Though in some places organizations and jurisdictions were 
able to temporarily provide resources to replace the loss of Title X 
funds, providers were not always able to provide the same scope of 
services or seamless care coordination that Title X projects can 
provide. Public comments from those organizations made clear that they 
were not able to provide the same breadth of services, nor were they 
able to provide services with the same schedule of discounts for low-
income clients.
    The Department disagrees that Title X grant funds allow for the 
``creation of slush funds'' or that those funds are ``fungible.'' As 
stated above, the Department has multiple methods by which it confirms 
that grant funds are spent for grant purposes, and it has concluded 
that grantees comply, not just with section 1008, but with 
Congressional directives and other requirements of the program. Again, 
the 2019 rule could point to no significant compliance issues related 
to the diversion of Title X grant funds, and a fresh review of decades 
of evidence has uncovered no such issues. A ban on organizations 
receiving Title X funds for lawful activities outside of the Title X 
project would go beyond the 2019 rule and raise serious constitutional 
issues. And even if such a restriction might conceivably be lawful, the 
Department clearly has the discretion to open eligibility to the most 
qualified Title X providers.\9\
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    \9\ Zolna, M.R., & Frost, J.J. (2017, August 2). Publicly funded 
family planning clinics in 2015: Patterns and trends in service 
delivery practices and protocols. Guttmacher Institute. Retrieved 
from https://www.guttmacher.org/report/publicly-funded-family-planning-clinic-survey-2015.
---------------------------------------------------------------------------

B. Data on Negative Public Health Consequences of 2019 Rule

    Comments: A few comments took issue with data presented in the 
NPRM. They stated that the Department used flawed data and failed to 
account for the effects of COVID-19, instead attributing the loss of 
grantees and subrecipients and the decline in services to the 2019 
rule. One comment stated that the Department does not have data to 
assess the effect of the 2019 rule. Another comment argued that the 
decline in clients served is the result of a long time decline since 
the 2000 rule. One of those same comments reflected the belief that the 
decline in services is instead related to changes in insurance, changes 
in poverty, and use of the most effective contraceptive methods, and 
that declines have been continuous since 2000.
    Some of the comments also took issue with the Department's position 
that the withdrawal of grantees from the program in response to the 
2019 rule resulted in a decline in services, as they stated those 
services were continued with state and private funds and not 
discontinued, and the Department's claims of fewer services provided is 
``a red herring.'' The same comment pointed out the proposed rule noted 
that seven states saw an increase in clients after the 2019 rule. 
Another comment cited Planned Parenthood data showing that Planned 
Parenthood provided more services in 2020 compared to 2019 and that 
other providers stepped in to fill the gaps in services left when 
Planned Parenthood exited the Title X program. It cited Ohio as an 
example and said that additional clients would be served post-COVID-19. 
A final opposing comment claimed that the number of new providers 
applying for Title X funds increased after the publication of the 2019 
rule.
    In contrast, numerous comments supported the 2021 NPRM and shared 
data on the negative impact that the 2019 rule has had in their states 
and communities, reinforcing the Department's statements in the NPRM. 
Many of the comments spoke to the drastic reduction in clients they 
were able to serve after the 2019 regulation. One comment stated, 
``throughout the history of Title X, since its inception in 1970, there 
has never been as sharp a decline in the number of patients served by 
the program as occurred between 2018 and 2019.'' More than losing 
numbers of clients, numerous comments spoke to the types of clients 
they have not been able to serve and the nature of services that are 
being lost because clients cannot afford those services.

[[Page 56151]]

Several comments noted that the 2019 regulation is disproportionately 
impacting rural regions, minority clients, adolescent clients, lower-
income individuals, and those without insurance, particularly in states 
that have not expanded Medicaid.
    Contrary to the comments that expressed Planned Parenthood 
affiliates were able to provide more services after leaving the Title X 
program, Planned Parenthood affiliates themselves, in addition to other 
commenters, indicated that without Title X funding, they have had to 
adjust their sliding fee scales, pushing more costs onto the clients. 
Comments stated that this has resulted in clients forgoing recommended 
tests, lab work, STI testing, clinical breast exams, and Pap tests in 
large numbers. Further, these comments provided evidence that some 
clients are choosing less effective methods of birth control due to 
costs. Other comments stated that the changes in fees have pushed their 
clients into seeking care elsewhere, interrupting their continuity of 
care. One comment reported that the loss of Title X funding resulted in 
loss of eligibility for the 340B Drug Pricing Program, requiring the 
agency to dispose of contraceptive methods purchased under the 340B 
Program and repurchasing them at higher market prices.
    The Attorneys General of 22 states and the District of Columbia 
commented that the emergency, one-time,\10\ and private funding made 
available to replace the loss of Title X funding has strained state 
budgets and could not be sustained, creating uncertainty for the future 
of their family planning providers. Additionally, several comments 
noted that the fundraising activities necessitated after leaving the 
Title X program have come at a cost and have resulted in providers 
having to scale back or eliminate educational and outreach programs in 
many states. Other comments noted that it was extremely burdensome to 
try to identify and recruit additional providers to fill the gaps left 
after the 2019 rule. Many commenters expressed strong interest in 
rejoining the Title X network once the current rule is replaced. 
Finally, several states reported that while their efforts were 
refocused on recruiting and onboarding new providers into their Title X 
network under the 2019 rule, they faced much resistance and/or a lack 
of interest, and their provider networks did not increase under this 
rule, continuing to adversely impact the communities they serve.
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    \10\ States that provided emergency funding include CA, MA, MD, 
NY, OR, WA, and VT.
---------------------------------------------------------------------------

    Response: The Department believes that the negative public health 
consequences of the 2019 rule are clear. The rule dramatically reduced 
access to essential family planning and related preventive health 
services for hundreds of thousands of clients, especially for the low-
income clients Title X was specifically created 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 Department disagrees that the data cannot distinguish between 
enactment of the 2019 rule and the pandemic. The 2019 rule officially 
took effect mid-year in 2019, but COVID-19 was not announced as a 
national emergency until early 2020. The Department has data to assess 
the impact of the 2019 rule through FPAR and grantee progress reports, 
including data on the decrease in the number of clients served in 2019 
when the rule was in place and prior to COVID-19. As stated in the 
Background section, 19 grantees, 231 subrecipients, and 945 service 
sites immediately withdrew from the Title X program. As a result, the 
Title X program provided services to 844,083 fewer clients in 2019 
compared to 2018, prior to the implementation of the 2019 rule, 
approximately a 22 percent decrease. A total of 41 states and two 
territories saw a decrease in clients served in 2019 compared to 2018; 
five states saw their number of clients served stay the same; and four 
states, five territories, and the District of Columbia saw an increase 
in clients served from 2018 to 2019, with the majority experiencing a 
small annual increase of between 70 to 3,000 clients. Minor 
fluctuations notwithstanding, 844,083 fewer clients were served, 
disproportionately impacting lower-income individuals, minority 
clients, adolescent clients, and those without insurance. There are 
currently six states with no Title X services available and seven 
states with Title X services available on a very limited basis. 
Ultimately, the hundreds of thousands of clients who lost access to 
Title X services as a result of the 2019 rule lost access to critical 
family planning and preventive health services. As noted in the 
background, this included declines in contraceptive services, Pap 
tests, clinical breast exams, and HIV and STI testing.
    The Department agrees that a few states were able to increase their 
service sites following the 2019 rule, but these are the exception. 
From 2018 to 2020, 34 states and territories saw a decrease in the 
number of service sites in their network, 18 saw no real change in 
their number of services sites, and only seven saw an increase in the 
number of service sites. OPA attempted to recruit new grantees to 
provide Title X services through a competitive funding opportunity, but 
OPA only received eight applications and was only able to provide 
services in three of the states with no or limited Title X services at 
the time. Some comments opposing the 2021 NPRM specifically cited Ohio 
as an example of a state that would be able to increase clients served 
post-COVID-19. Despite the state health department receiving additional 
funds to provide Title X services following the departure of another 
grantee, FPAR data from Ohio, however, do not provide any clear support 
for this claim and reinforce that capacity among entities is not 
necessarily equivalent. According to the FPAR data from Ohio, the state 
experienced a 10 percent decline in service sites between 2018 and 
2020, an 18 percent decline in clients from 2018 to 2019, and a 57 
percent decline in clients from 2019 to 2020. While many states and 
territories experienced a decline in clients from 2019 to 2020 due to 
COVID-19, Ohio's percentage decline in clients from 2019 to 2020 ranked 
18th in order of states from largest decline to smallest decline. 
Seventeen states experienced a larger decline in clients from 2019 to 
2020, and 41 states and territories experienced a smaller decline in 
clients. The data show that even if the same amount of funding is 
provided to a different set of grantees in a given area, it does not 
necessarily follow that the same number of clients will be served or 
same number of services will be provided, depending on the differences 
in grantee service capacity. Existing Title X grantees also experienced 
great difficulty recruiting new sites and new providers into their 
existing Title X networks under the 2019 regulations, as evidenced by 
the lack of states experiencing an increase in their number of service 
sites. Overall, it is clear that the 2019 rule directly resulted in a 
significant loss of grantees, subrecipients, and service sites, and 
close to one million fewer clients served from 2018 to 2019.
    While some states and organizations were able to provide family 
planning and related preventive health services in the absence of Title 
X funding, the comments made clear that they were not providing the 
full scope of services provided under the Title X program, they were 
not provided following the

[[Page 56152]]

same standards as in Title X, and the same schedule of discounts and 
subsidies were not applied as required in the Title X program. Finally, 
many of the states that provided emergency or one-time funds, or those 
organizations that were able to raise funds privately, indicated 
through their comments that they could only do so on a very short-term 
basis, that it was not sustainable for the long term, and that it came 
at a price--requiring elimination of other critical services.
    Given the data presented in the preamble and the data presented 
above, the Department disagrees with the claim that Title X services 
would improve after COVID-19 (absent a change in the 2019 rule). The 
loss in clients served, the states with no service providers, and the 
states with limited service providers occurred in 2019 after enactment 
of the 2019 rule and prior to COVID-19, making it unlikely that the 
number of clients served or services provided would increase to pre-
2019 levels or above without a change to the 2019 rule. Comparing FPAR 
data for 2018 (``typical year'') and 2019 (post 2019 rule but pre-
COVID), OPA estimates that 94% (789,960) of the total decrease 
(844,083) in family planning clients between 2019 and 2020 can be 
attributed to the 2019 rule. Further comparing FPAR data for 2018 
(``typical year'') and 2020 (post-COVID), OPA estimates that 63% (or 
1.5 million) of the total decrease (2.4 million) in family planning 
users between 2018 and 2020 can be attributed to the final rule. The 
grantees and subrecipients that left the program have indicated that 
they will not return to the program under the 2019 rule. Coupled with 
the lack of additional applicants to the Department's funding 
opportunity, the Department maintains the decline in access, clients, 
and services from 2018 levels will continue until a new rule is in 
place.

C. Grantee and Subrecipient Compliance

    Comments: Several comments expressed concern that the 2021 NPRM did 
not include language from 59.1 in the 2019 rule, stating, ``the 
requirements imposed by these regulations apply equally to grantees and 
subrecipients.'' Several comments also expressed concern that the 2021 
NPRM did not include language from 59.13 specifically requiring 
grantees to provide assurance that their project does not provide 
abortion and does not include abortion as a method of family planning. 
One comment stated that ``[t]he removal of an explicit compliance 
requirement, without at minimum an explanation that subrecipients are 
assumed to have to comply with all Title X regulations, suggests that 
such compliance is no longer required.''
    Another comment claimed that the departure of providers from the 
Title X network after the introduction of the 2019 rule confirmed that 
Title X funding had been used by those providers for impermissible 
purposes. Additionally, the comment claimed that the withdrawal 
demonstrates an unwillingness to comply with program requirements, and 
that ``healthcare providers were accepting Title X funding for years 
without complying with the statutory requirements of the program.''
    Response: The Department disagrees with the comments and does not 
believe that it is necessary to include language within the Title X 
regulations stating that the regulations apply equally to grantees and 
subrecipients because this is already a requirement in the HHS grants 
regulations that apply to Title X grantees. All Title X grantees are 
subject to 45 CFR part 75, Uniform Administrative Requirements, Cost 
Principles, and Audit Requirements for HHS Awards. In fact, Title X 
Notices of Funding Opportunity (NOFOs) state that successful applicants 
that accept an award agree that the award and all activities under the 
award are subject to all provisions of 45 CFR part 75. Specifically, 45 
CFR 75.352 sets out the requirements for pass-through entities and 
clearly specifies that ``all pass-through entities must (a) ensure that 
every subaward is clearly identified to the subrecipient as a subaward 
and includes the following information at the time of the subaward and 
if any of these data elements change, include the changes in subsequent 
subaward modification. . . . Required information includes . . . (2) 
All requirements imposed by the pass-through entity on the subrecipient 
so that the Federal award is used in accordance with Federal statutes, 
regulations and the terms and conditions of the Federal award.'' Given 
that Title X grantees are required to follow 45 CFR part 75, and since 
45 CFR part 75 makes clear that all requirements of the grant, 
including federal statutes, regulations, and terms and conditions of 
the federal award, apply to all subrecipients, the Department believes 
it is clear that the Title X regulations will continue to apply equally 
to all grantees and subrecipients without needing to include separate 
language in the Title X regulations.
    Similarly, the Department does not deem it necessary to include 
language within the regulation itself requiring grantees to provide 
assurance that their project does not provide abortion and does not 
include abortion as a method of family planning. The Department has 
explicitly stated in all NOFOs that all grantees must comply with the 
Title X statute, regulations, and legislative mandates, and applicants 
certify in the application materials that they ``[w]ill comply with all 
applicable requirements of all other Federal laws, executive orders, 
regulations, and policies governing this program.'' Additionally, 
compliance with program statutes and appropriations act requirements is 
included as a standard term of the grant award. Therefore, during the 
application process, and by accepting funds, grantees have assured 
their compliance to the statute, regulations, and legislative mandates.
    The Department also disagrees with the contention that withdrawal 
of organizations following the 2019 rule proves that these 
organizations were non-compliant with the statutory requirements. The 
primary reasons cited by most grantees for withdrawing from the Title X 
program after promulgation of the 2019 rule was out of concern that the 
2019 rule interfered with the patient-provider relationship and 
compromised their ability to provide quality healthcare to all clients. 
For certain grantees, the regulation was also in direct conflict with 
laws established by their state.
    Furthermore, there is no evidence to suggest that the grantees that 
withdrew from the Title X program had had any difficulties complying 
with the Title X statute, regulations, or legislative mandates. OPA 
practices, and practiced long before the 2019 rule, robust monitoring 
processes to ensure grantee compliance with the statute and 
regulations, including through regular grant reports, compliance 
monitoring visits, and legally required audits. As stated in the 
Background section, close oversight of Title X grantees for almost two 
decades under the 2000 rule uncovered no misallocation of Title X funds 
by grantees. OPA oversight did identify occasional instances over the 
years where grantees needed to update 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. The Department believes that grantee 
compliance with the Title X statute and regulations has not been an 
issue throughout the history of the Title X program, and the compliance 
monitoring methods that have historically been applied by OPA prior to 
the 2019 rule have ensured that

[[Page 56153]]

grantees have an understanding of the statute and how to comply with 
it. The Department rejects as without merit the comments that these 
grantees were accepting Title X funding for years without complying 
with statutory requirements. Neither the 2019 rule itself nor any 
comments to the 2021 NPRM cited evidence of widespread noncompliance.

D. Application of Conscience and Religious Freedom Statutes to Title X

    Comments: The Department received thousands of comments on the 
preamble language concerning the application of the conscience statutes 
to Title X. As further discussed in the NPRM, Congress has passed 
several laws protecting the conscience rights of providers, 
particularly in the area of abortion. For instance, under 42 U.S.C. 
300a-7, the Church amendments, grantees may not require individual 
employees who have objections to abortion to provide such abortion 
counseling, or those who have objections to sterilization procedures to 
perform, assist in the performance of, or provide counseling regarding 
sterilizations. Since 2005, Congress has also annually enacted an 
appropriations rider, the Weldon amendment, which extends non-
discrimination protections to other ``health care entities'' who refuse 
to counsel or refer for abortion. See, e.g., Consolidated 
Appropriations Act, 2021, Public Law 116-260, Div. H, section 507(d) 
(2020). Under these statutes, objecting providers or Title X grantees 
are not required to counsel or refer for abortions.
    Many commenters expressed a belief that the statutory conscience 
protections prohibited the agency from promulgating any counseling or 
referral requirements. Conversely, some asserted that the conscience 
statutes have no bearing on what requirements Title X could impose on 
grantees by regulation. Many comments asserted that these statutes had 
to be incorporated into the Title X regulatory text for them to be 
operative or the rule to be lawful. Some stated that the statutes 
themselves violated the separation between church and state. Several 
other comments cited a concern that applications from providers 
objecting to abortion counseling or referral would not be favorably 
evaluated. Many also suggested that the Department should simply allow 
for abortion counseling and referral rather than requiring it, since 
the conscience statutes protect objecting providers from those 
requirements in any case.
    Beyond the Church and Weldon Amendments, a few comments also stated 
that requiring abortion counseling or referral automatically violated 
the Religious Freedom Restoration Act (RFRA), 42 U.S.C. 2000bb through 
42 U.S.C. 2000bb-4. At least one comment suggested that the counseling 
and referral requirements coerced speech in violation of the First 
Amendment for those providers who object.
    Response: The conscience statutes have been the subject of multiple 
rulemakings and numerous lawsuits in the last 13 years. Most recently, 
the Department finalized a rule in 2019 providing definitions and an 
enforcement mechanism for several statutes protecting medical providers 
who have conscience-based objections to certain activities. Protecting 
Statutory Conscience Rights in Health Care; Delegations of Authority, 
84 FR 23170 (May 21, 2019). That rule was vacated by three different 
courts. New York v. HHS, 414 F. Supp. 3d 475, 536 (S.D.N.Y. 2019) 
(appeal in abeyance); Washington v. Azar, 426 F. Supp. 3d 704, 722 
(W.D. Wash. 2019) (same); City & Cty. of San Francisco v. Azar, 411 F. 
Supp. 3d 1001 (N.D. Cal. 2019) (same). While the statutes may at times 
interact with the requirements of Title X, interpreting these laws is 
beyond the scope of this rule and the HHS Office for Civil Rights (OCR) 
has been delegated authority to receive complaints under these 
provisions.
    Moreover, as the DC Circuit pointed out when the Weldon Amendment 
was enacted and the 2000 Title X rule was in effect, ``a valid statute 
always prevails over a conflicting regulation,'' Nat'l Family Planning 
& Reprod. Health Ass'n v. Gonzales, 468 F.3d 826 (D.C. Cir. 2006). This 
is true whether an overriding statute is incorporated into regulatory 
text or not. The applicability of other rules and laws are best 
evaluated by consulting those rules and laws and then seeking guidance 
from the agencies responsible for implementing them. Particularly in 
areas where the administrative rules may be modified or statutory 
directions may change from appropriation to appropriation, it is unwise 
for OPA to formalize interpretations beyond its own statutory 
authority.
    Irrespective of the points made above, as recounted in the NPRM, 
objecting individuals and grantees will not be required to counsel or 
refer for abortions in the Title X program in accordance with 
applicable federal law. OPA has long worked with grantees and providers 
to ensure appropriate compliance with conscience laws as well as 
continuity of care. As stated above, OCR has been delegated authority 
to receive any complaints related to the conscience protections and 
will continue to enforce them. As discussed in the NPRM, recognition of 
provider conscience rights has been the position of the Department 
since before the 2000 rule. See 65 FR at 41274 (2000 rule, stating that 
under ``42 U.S.C. 300a-(d), ``grantees may not require individual 
employees who have such objections to provide such counseling.''). 
However, as also discussed in the 2000 final rule, the Secretary was 
unaware then--and is still unaware--``of any current grantees that 
object to the requirement for nondirective options counseling.'' Id.
    Just as non-objecting providers should not dictate the provision of 
information and referrals by those who do object, the existence of 
statutory conscience protections for providers does not preclude other 
willing providers from providing referrals or counseling for abortion 
within the program. With this final rule, the Department is emphasizing 
the importance of ensuring access to equitable, affordable, client-
centered, quality family planning services. Client-centered care is 
defined as being respectful of, and responsive to, individual client 
preferences, needs, and values, and ensures that the client's values 
guide all clinical decisions. With an emphasis on providing services 
that are client-centered, the default should be the fullest provision 
of information to clients. Providers may avail themselves of existing 
conscience protections and file complaints with OCR, which will be 
evaluated on a case-by-case basis as is done with other complaints.
    As noted in previous iterations of both sets of rules, the 
conscience provisions and Title X rules have existed side by side for 
decades with very little conflict, or even interaction. From 1993 to 
2017, Title X received no reports of grantees or individuals objecting 
to the regulatory requirement to counsel or refer for abortions when 
requested. See Nat'l Family Planning & Reprod. Health Ass'n, 468 F.3d 
at 830 (``[T]here are structural reasons to doubt that the issue will 
ever come up. In 2000 HHS Secretary Shalala declined to create a 
specific exception from the pending [Title X] regulation's mandatory 
referral requirement for organizations resisting provision of abortion 
counseling or referrals; she explained that she was ``unaware of any 
current grantees that object to the requirement for nondirective 
options counseling, so this suggestion appears to be based on more of a 
hypothetical than an actual concern.''). As with any issue facing Title 
X grantees and applicants, the program will work to provide guidance to 
grantees and coordinate any

[[Page 56154]]

conflicts with the OCR. A case-by-case approach to investigations will 
best enable the Department to deal with any perceived conflicts within 
fact-specific situations.
    The Department declines to definitively interpret RFRA or the First 
Amendment in this context for largely the same reasons. Not only do the 
conscience protections more specifically allow providers to object to 
referral and counseling for abortion requirements, but the Title X 
rules in force for decades prior to the 2019 rule also existed side by 
side with RFRA and the First Amendment with no conflict. However, in 
light of the comments received, and to eliminate any confusion, the 
Department has noted in this final regulation that ``[p]roviders may 
separately be covered by federal statutes protecting conscience and/or 
civil rights.''

E. Options Counseling

    Comments: The Department received thousands of comments expressing 
support for ``the reinstatement of the requirement to offer 
nondirective options counseling to pregnant patients.'' Many comments 
expressed support for reversing the 2019 rule's restrictions on what 
referrals can be provided to clients and allowing providers to offer 
patients complete information about their healthcare options and refer 
patients to providers who offer services to meet those needs. One 
comment stated that ``reinstating the 2000 regulations would remove 
this undue governmental interference into medical care and will help 
ensure patients receive medically accurate, comprehensive information 
from their physicians.''
    The Department also received comments in opposition to removing 
restrictions on referring for abortion services and requiring 
nondirective counseling. Several comments opposed removing restrictions 
on what referrals can be provided to clients in general, and a few 
opposed removing restrictions which state that only advanced practice 
providers can provide nondirective counseling. Many comments opposing 
the rule expressed a belief that the information and counseling 
requirements in this provision violate section 1008 of the Title X 
statute. Others believed that requiring ``that grantees refer (sic) 
individuals to abortion providers conflicts with the free speech and 
religious freedom of grantees.'' Still others expressed concern that 
the requirement could limit the type of providers in the program due to 
conscience concerns.
    Response: The Department appreciates the comments in support of 
this provision. The Department believes that offering pregnant clients 
the opportunity to receive neutral, factual information and 
nondirective counseling on all pregnancy options--and providing 
referral upon request for option(s) the client wishes to receive--are 
critical for the delivery of quality, client-centered care. The 
Department agrees that restoring this provision will remove unnecessary 
limitations governing the patient-provider relationship and will enable 
healthcare providers to offer complete and medically accurate 
information and counseling to their clients.
    The Department's response to comments opposing this provision is 
included earlier in Section II. A. Compliance with Section 1008 (42 
U.S.C. 300a-6) and D. Application of Conscience Statutes to Title X. 
The NPRM language for this provision would restore the regulatory text 
from the 2000 regulation, which successfully governed the Title X 
program for decades without opposition from major medical organizations 
and was widely accepted by grantees.

F. Subrecipient Nondiscrimination

    Comments: The Department received many comments on state policies 
restricting subrecipient participation for reasons unrelated to the 
provider's ability to provide care. The majority of these comments 
favored a regulatory prohibition on such restrictions because they 
often exclude the best family planning providers for no discernible 
purpose. Many comments stated that ``State policies putting 
restrictions on how state funds are allocated, called `tiering,' make 
it difficult or impossible for privately operated reproductive health-
focused providers to receive funding. Tiering and other prohibitions 
against abortion providers often exclude the specialist providers that 
are the most qualified and best equipped to help Title X patients 
achieve their family planning goals.'' Such restrictions, which are in 
place in approximately 15 states, can make access for certain sub-
populations and geographic areas more difficult. Many comments stressed 
that ``expelling well-qualified, trusted family planning providers from 
publicly funded health programs like Title X has adverse effects on 
patients' access to critical family planning and sexual healthcare.''
    The Department also received many comments, including from multiple 
state Attorneys General, condemning any regulation in this area. Many 
of these objections stated that such a regulation would undermine 
federalism and ``intrude on the States' self-governance for no good 
reason,'' and, most prominently, violate the Congressional Review Act, 
5 U.S.C. 801-808. Under that law, an agency may not promulgate a rule 
that is ``substantially the same'' as one that has been disapproved by 
Congress. In 2016, the Department enacted a rule barring projects from 
rejecting sub-grantees for non-programmatic reasons. 81 FR 91852 (Dec. 
19, 2016). Congress subsequently revoked the rule. P.L. 115-23 (4/13/
2017). Multiple comments asserted that any regulation in this area 
would be unlawful unless Congress specifically authorized it.
    Response: All proposed additions to the 2000 rule received an 
overwhelmingly positive response, except the proposal to include a 
subrecipient non-discrimination provision. After carefully considering 
several factors, the agency is declining to include a subrecipient non-
discrimination provision in this rulemaking. Foremost among the 
Department's considerations is the sense of urgency in the interest of 
public health to complete this rulemaking. This schedule allows for a 
final rule to be effective before the award of the next round of 
competitive funding for the Title X program. This, in turn, will enable 
applicants that previously withdrew from participation in the program 
as a result of the previous regulation to apply for funding.
    The Department still believes state restrictions on subrecipients 
unrelated to care hamper the ability of the program to achieve its 
goals. However, the overriding task of this rulemaking is to undo the 
negative public health effects of the previous rule. That result is 
most effectively reached by not including a subrecipient non-
discrimination provision in this rulemaking. Organizations in states 
with restrictive laws may still apply directly to receive Title X 
grants (see PHS Act sec. 1001(b); 59.3).

G. Other Comments

    Comments: While many comments were specific to certain sections of 
the proposed rule, a sizeable number were more general in nature, or 
commented on portions of the preamble. Many of these general comments 
were summarized in detail in the sections above, and the remainder of 
the general comments are summarized here.
    Of those that support the proposed rule, a large number of comments 
expressed general support for removing the harmful effects of the 2019 
rule on Title X services. A similarly large

[[Page 56155]]

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 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 patient-provider 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 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

Sec.  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, low-income, 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 
rule's 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 ``FDA-approved'' contraceptive products 
and reinstatement of the term ``medically approved'' to the definition. 
Several comments were supportive of not

[[Page 56156]]

including women whose employers do not cover contraception for 
religious reasons in the definition of low-income. One comment 
expressed support for the NPRM's ``returned focus on Title X's priority 
population--low-income clients--and removal of the 2019 rule's re-
definition of `low income' to use the program to pay for contraceptive 
services for any people whose employers refuse to include coverage for 
such services in their employer sponsored insurance due to religious or 
moral objections.'' Several comments also expressed support for using 
more inclusive terminology throughout the NPRM and expressed that 
```client' is more reflective of the diverse population of patients 
served by the Title X program.''
    Several comments, while supportive of the definitions included in 
the NPRM, did request specific revisions to many of the new or revised 
definitions. Several comments requested that the Department explicitly 
include systemic racism within the definition of health equity. Another 
comment requested that the Department revise the definition of health 
equity by expanding ``the umbrella term `socially determined 
circumstances' to `other circumstances that are socially, economically, 
demographically, or geographically determined.' '' One comment 
requested that the Department revise the definition of adolescent-
friendly services to include ``developmentally appropriate services 
that support the healthy cognitive, physical, sexual, and psychosocial 
development of adolescents as they transition from childhood to 
adulthood and account for their unique needs, including with respect to 
confidentiality, legal status, and autonomy.'' Other comments asked the 
Department to revise the definition of inclusivity to include non-
religious people and the intersex community. One comment requested that 
the definition of trauma-informed care be revised to prevent future 
discrimination of transgender people by ``clarifying that a trauma-
informed program should not result in discrimination against any 
population.''
    The Department also received several comments opposing the new or 
revised definitions. A few comments opposed the definition of client-
centered care and felt that it raised conscience concerns. Other 
comments opposed the definition of family planning services and 
specifically opposed removing abstinence and preconception health from 
the definition. One comment opposed the definition and said that 
``medically approved'' did not include natural family planning. Another 
comment questioned why the definition of family planning services did 
not emphasize ``supporting unexpected pregnancies with assistance 
required by families and mothers--including emotional, educational, 
financial, and healthcare supports.'' Other comments expressed general 
opposition to the definition of family planning services and felt that 
the definition included abortion and abortion-related services.
    One comment stated that the definition of health equity was vague 
and undermined the priority for serving low-income clients. Another 
comment stated that the focus on health equity was ``targeting minority 
communities to restrict pregnancy,'' and another stated that the focus 
on equity was unnecessary because of protections already included in 
the Constitution. One comment opposed the definition of cultural and 
linguistically appropriate services and expressed that ``the phrase 
`culturally and linguistically appropriate services' may bless health 
practices, based on cultural norms, that lead to negative health 
outcomes.'' One comment opposed the definition of ``trauma-informed'' 
and said it was vague and that it was not clear what was required to be 
trauma-informed.
    One comment opposed the definition of inclusivity and felt that it 
would drive faith-based providers out of the program. Another comment 
took issue with the definition of ``inclusivity'' and stated that 
``segregation or prioritization of Title X services by protected 
classes such as race violates the Constitution and several civil rights 
laws.'' A few comments opposed the use of the word ``client'' instead 
of ``woman'' throughout the NPRM and felt that the change in language 
was a disservice to women. Two comments opposed removing women who 
cannot receive contraception from their employer because they have a 
religious or moral objection from the definition of low-income. A few 
comments opposed the definition of quality healthcare. One comment 
opposed including client-centered and equitable within the definition 
of quality. Still another comment stressed that improving the quality 
of healthcare is a ``dynamic process'' and that ``this dynamism 
requires a nimbleness often unattainable by national requirements.'' 
The commenter requested that the definition of quality be amended to 
allow ``maximum flexibility at the state and local level to establish 
standards of care.''
    Response: The Department appreciates the supportive comments 
regarding the new and revised definitions in the NPRM and believes that 
clear definitions for terms used throughout the regulations are 
important for consistent implementation. The Department acknowledges 
comments requested revisions to many of the definitions; however, the 
Department believes that it is important to use widely accepted and 
commonly used definitions from other federal agencies and national 
medical organizations as the foundation for the regulation. For this 
reason, the Department will not revise the proposed definitions as 
requested by several comments.
    The Department disagrees that the definition of client-centered 
care raises conscience concerns. The purpose of the rule and the 
definitions is to refocus the program as a client-centered one, where 
well-being of the patient, not the provider, is the primary goal. As 
stated earlier, providers may avail themselves of existing conscience 
protections and file complaints with OCR, which will be evaluated on a 
case-by-case basis as is done with other complaints.
    The Department also disagrees with comments objecting to the 
definition of family planning services. The definition of family 
planning services within the NPRM is consistent with the definition of 
family planning services in QFP. Contrary to some of the comments 
opposed to the definition of family planning services, the definition 
does include preconception health, natural family planning, and 
abstinence (as a component of natural family planning). Family planning 
services include a broad range of services related to achieving 
pregnancy, preventing pregnancy, and assisting clients in achieving 
their desired number and spacing of children. Also, given that the 
focus of Title X is on helping clients achieve pregnancy, prevent 
pregnancy, and achieve their desired number and spacing of children, 
the Department responds to comments requesting that Title X provide 
support to clients once they become pregnant by noting that this is 
beyond the scope of the Title X program. Further, as is clear from 
section 1008 of the Title X statute, none of the funds appropriated for 
Title X are used in programs where abortion is a method of family 
planning. No court has found the decades-long practice of referral upon 
request to violate that prohibition.
    The Department disagrees with comments expressing concern with the 
definitions of health equity, cultural and linguistic appropriateness, 
inclusive, low-income, quality, and trauma-informed. The definitions 
proposed in the NPRM are widely used definitions from other federal 
agencies and major

[[Page 56157]]

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 59.5(b)(1) and 
59.5(b)(6) 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 OPA's 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 
state-specific 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, 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.

Sec.  59.5(a)(1). Broad Range of Acceptable and Effective Medically 
Approved Family Planning Methods and Services

    In the NPRM, the Department proposed revising section 59.5(a)(1) 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 client's method of choice. In addition, the NPRM 
specified that the referral must ``not unduly limit the client's 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 client's method of choice and the referral must not unduly limit 
the client's 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 59.5(a)(1), especially in support of the requirement that Title 
X projects provide a broad range of acceptable and effective medically 
approved family 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 provider-administered 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 client's access to their method of choice.'' Many comments 
expressed support for requiring that sites refer clients if the site 
does not offer the client's method of choice. Some comments expressed 
concern that it was unclear what was meant by ``not unduly limit the 
client's 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 client's access. Some comments asserted that 
requiring referrals for a client's 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

[[Page 56158]]

does not go far enough.'' One comment asked the Department to ``clearly 
outline the reasons and/or circumstances under which a Title X site may 
be excused from offering a broad range of medically approved methods 
and parameters, including a maximum `reasonable' distance a Title X 
patient would have to travel to get their method of choice.'' Another 
comment asked the Department to closely monitor the accessibility of 
referrals made by Title X sites. Other comments asked the Department to 
provide a specific number of minutes or miles from the Title X project 
to the referral location and to require that referrals be only to 
another Title X site to ensure the same discounted services would be 
available.
    Response: The Department appreciates the supportive comments for 
this provision in the 2021 rule. Since acceptable and effective 
medically approved family planning methods can change over time, the 
Department does not believe that additional specificity regarding what 
is meant by a broad range of methods and services is necessary within 
the regulatory text. Instead, the Department will provide additional 
guidance and technical assistance to assist grantees in complying with 
the regulation and ensuring access to a broad range of acceptable and 
effective methods and services across their service sites.
    The Department acknowledges the comments expressing concern with 
allowing an organization to participate in a Title X project if it only 
offers a single method of family planning as long as the overall 
project offers the broad range of methods and services. For much of the 
Title X program's history, including in the 2000 regulations, the 
regulation has included this provision. The Department believes that 
retaining this provision in the 2021 rule is important to ensure 
flexibility in addressing community needs and recognizes that not all 
Title X service sites may be able to provide access to all methods and 
services. The Department will monitor and provide technical assistance 
to ensure that each grantee provides access to the broad range of 
acceptable and effective medically approved family planning methods and 
services to their clients.
    The Department disagrees that the referral requirement will result 
in faith-based and natural family planning providers leaving the Title 
X network. This is in part based on our longstanding experience with 
the program which for decades has included faith-based and natural 
family planning providers. The requirement for referral is intended to 
support continuity of care for Title X clients. There are any number of 
opportunities by which this requirement could be fulfilled including 
directly by the clinic site or by the grantee in instances when a 
provider objects or lacks capacity to fulfill this requirement. An 
array of providers, including those that only offer a single method on-
site, have successfully participated in the Title X program for 
decades. The Department will monitor and provide technical assistance 
to ensure that supporting client access to requested methods and 
services does not violate federal conscience laws. As part of the 
statutory mandate, Title X projects must provide natural family 
planning services, and the program will work with projects to ensure 
they provide all statutorily required services. Again, the Department 
is emphasizing in this final rule the importance of ensuring access to 
client-centered care. Client-centered care is defined as being 
respectful of, and responsive to, individual client preferences, needs, 
and values, and ensuring that client values guide all clinical 
decisions. With an emphasis on providing services that are client-
centered, the default should be the fullest provision of information 
and services to clients.
    The Department understands, based on the comments received, that it 
is challenging to include within the regulation a requirement that 
sites must provide a referral that does ``not unduly limit the client's 
access.'' The Department fully recognizes that the referrals available 
to each Title X site will differ depending on what other referral 
resources are available within or near the community. Some communities 
may have access to a wide range of providers to refer clients to within 
the same community, while other sites may need to refer clients to 
organizations located farther away. Given the challenges in having one 
standard definition for what is considered undue burden across all 
Title X sites, the Department has decided to revise section 59.5(a)(1) 
to remove the requirement that ``the referral must not unduly limit the 
client's access to their method of choice.''
    In addition to the revision to remove this requirement, the final 
rule will also include one technical correction for this provision. The 
Department recognizes that if a Title X site does not have the client's 
method of choice available on-site, the provider may be able to provide 
the client with a prescription for their method of choice, rather than 
having to provide a referral to another provider. To better account for 
this, the final provision will now require sites that are unable to 
provide clients with access to a broad range of acceptable and 
effective medically approved family planning methods and services to 
provide a prescription to the client for their method of choice or 
referrals, as requested. As a point-of-entry to care, Title X sites 
often have robust referral networks with other safety-net agencies that 
are attuned to the needs of the client populations that they serve. 
While a prescription or referral does not guarantee a client the same 
schedule of discounts as at a Title X site, experience suggests that 
the family planning safety net recognizes and takes steps to limit 
accessibility burdens, including financial constraints, for the clients 
they serve. In addition, the Department will provide additional 
guidance and technical assistance to grantees to help them promote 
accessibility and limit patient burden.
    With the revisions noted above, the revised language for the 2021 
rule for 59.5(a)(1) is, ``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 prescription 
to the client for their method of choice or referrals, as requested.'' 
This revised language is adopted as final.

Sec.  59.5(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

    In the NPRM, the Department proposed revising section 59.5(a)(3) of 
the 2000 regulations. In addition to providing services that protect 
the dignity of the individual as required in the 2000 regulations, the 
NPRM stated, ``Provide services in a manner that is client-centered, 
culturally and linguistically appropriate, inclusive, and trauma-
informed; protects the

[[Page 56159]]

dignity of the individual; and ensures equitable and quality service 
delivery consistent with nationally recognized standards of care.'' 
These revisions were aimed at increasing access and ensuring equity in 
all services provided, which the Department believes is especially 
important for the Title X program with a statutory priority on serving 
low-income clients. In addition, the Department believes that the 
revisions will result in improved services for clients.
    Comments: The Department received numerous comments in support of 
this revised provision. Many comments expressed full support for the 
provision and urged the Department to adopt it as quickly as possible. 
Others expressed specific support for the requirement that services be 
client-centered: ``We support that the proposed rule names the 
importance of using client-centered models of care.'' Still others 
expressed specific support for the inclusion of QFP within the 2021 
rule and the requirement that Title X services be consistent with 
nationally recognized standards of care. One comment said, ``[T]he 
Proposed Rule will again base the standards of care for the Title X 
program on the QFP guidelines and require that Title X clients receive 
high-quality, client-centered care that includes comprehensive, 
medically accurate counseling and information, and referrals for any 
other services sought.''
    The Department received a few comments opposed to this provision. 
One comment felt that requiring services to be client-centered, 
inclusive, and trauma-informed would create additional ``burden on 
applicants and providers to ensure equity within their programs.'' 
Another comment argued with the definition of client-centered care and 
believed that it violated conscience protections. Still another 
expressed concern that the requirement for equity in conjunction with 
the requirement for inclusivity would violate civil rights laws and the 
Constitution ``by giving certain classes of people preferential 
treatment.''
    Response: The Department appreciates the comments in support of 
this provision and agrees that providing services in a manner required 
by this provision will advance equity, increase access, improve 
outcomes for Title X clients, and reinforce the longstanding 
requirement that ``[s]ervices must be provided in a manner which 
protects the dignity of the individual.'' The Department disagrees that 
the requirements of this provision will result in additional burden for 
applicants or providers, rather the requirements of this provision 
simply ensure that all Title X services are of the highest quality and 
align with nationally recognized standards of care. The Department also 
disagrees that the requirements of this provision violate conscience 
protections and provides a specific response to comments concerning 
conscience earlier in Section II. D. Application of Conscience Statutes 
in Title X. Finally, the requirements of this provision do not give 
preferential treatment to any clients, but rather aim to ensure that 
all people can actively participate in and benefit from family planning 
services. In conclusion, the Department adopts the language from the 
NPRM for Sec.  59.5(a)(3) as final without revisions.

Sec.  59.5(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

    The NPRM proposed the same regulatory text for this provision as 
has been included in the 2000 regulations, which read ``Provide 
services without regard of religion, race, color, national origin, 
disability, age, sex, number of pregnancies, or marital status.''
    Comments: The Department received several comments regarding this 
provision and specifically expressing concerns with the phrase 
``without regard of.'' Several comments expressed concern with the 
specific phrase and stated that ``if Title X providers are intended, as 
stated in the proposed rule, to work towards advancing health equity, 
it is imperative that care is delivered in a way that intentionally 
centers and considers the identity and needs of the patient.'' Several 
comments requested that the Department revise the provision to instead 
say ``provide services in a manner that does not discriminate against 
any patient based on religion, race, color, national origin, 
disability, age, sex, number of pregnancies, or marital status'' which 
they felt better supports health equity.
    Response: The Department agrees with the comments and believes that 
revising the language as requested more clearly meets the intent of 
this provision, which is to prevent discrimination in the provision of 
services.
    In addition, the Department is updating ``sex'' in 59.5(a)(4) to 
include sexual orientation, gender identity, and sex characteristics 
consistent with the section 1557 of the Affordable Care Act, case law, 
Executive Order 13988 (86 FR 7023, Jan. 25, 2021), and Departmental 
policy (https://www.hhs.gov/about/news/2021/05/10/hhs-announces-prohibition-sex-discrimination-includes-discrimination-basis-sexual-orientation-gender-identity.html). In Bostock v. Clayton County, 140 S. 
Ct. 1731 (2020), the U.S. Supreme Court held that Title VII of the 
Civil Rights Act of 1964 prohibition on employment discrimination based 
on sex encompasses discrimination based on sexual orientation and 
gender identity. Courts have now begun consistently interpreting 
similar language--`because of sex'-- in other statutes to encompass 
these protections. See Grimm v. Gloucester Cty. Sch. Bd., 972 F.3d 586, 
616-617 (4th Cir 2020) (relying on Bostock to interpret Title IX as 
prohibiting policy prohibiting transgender student from using bathroom 
consistent with his gender identity). Moreover, as the Department of 
Justice has recently emphasized ``Discrimination against intersex 
individuals is similarly motivated by perceived differences between an 
individual's specific sex characteristics and their sex category 
(either as identified at birth or some subsequent time) . . . it is 
impossible to discuss intersex status without also referring to sex.'' 
Title IX (justice.gov). As a result of the case law and Administration 
policy, the Department adds ``sexual orientation'', ``gender 
identity'', and ``sex characteristics'' to 59.5(a)(4).\11\ The revised 
language for the 2021 rule for 59.5(a)(4) is ``Provide services in a 
manner that does 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.'' This revised language is adopted as final.
---------------------------------------------------------------------------

    \11\ This language reflects requirements on Title X projects 
principally engaged in healthcare activities under 42 CFR part 59. 
If grants for the production of informational materials were again 
to be made under PHSA Sec.  1005, this definition might not apply.
---------------------------------------------------------------------------

Sec.  59.5(a)(8). Charges for Services With a Schedule of Discounts

    In the NPRM, the Department proposed revising section 59.5(a)(8) of 
the 2000 regulations by including widely accepted billing practices 
from the 2014 Title X Program Requirements. The NPRM text reads, 
``Provide that charges will be made for services to clients other than 
those from low-income families in accordance with a schedule of 
discounts based on ability to pay, except that charges to persons from 
families whose annual income exceeds 250 percent of the levels set 
forth in the most recent Poverty Guidelines issued pursuant to 42 
U.S.C.

[[Page 56160]]

9902(2) will be made in accordance with a schedule of fees designed to 
recover the reasonable cost of providing services. (i) Family income 
should be assessed before determining whether copayments or additional 
fees are charged. (ii) With regard to insured clients, clients whose 
family income is at or below 250 percent FPL should not pay more (in 
copayments or additional fees) than what they would otherwise pay when 
the schedule of discounts is applied.''
    Comments: The Department received several comments on this 
provision specifically seeking closer alignment of HRSA's (Health 
Resources & Service Administration) Health Center Program (authorized 
by Section 330 of the PHS Act) and OPA's Title X Program to minimize 
administrative burden for dually funded grantees. Specifically, one 
comment suggested modifying the proposed language in Sec.  
59.5(a)(8)(ii) to include additional language about sliding fee 
discounts from the Health Center Program Compliance Manual that states 
that sliding fee discounts are ``subject to potential legal and 
contractual restrictions.'' Another comment lauded Sec.  59.5(a)(8)(ii) 
for ensuring that clients with family income at or below 250 percent 
FPL do not pay more than what they would otherwise pay under the 
schedule of discounts; however, the comment expressed that this 
``requirement violates insurance contracts and contradicts the guidance 
of other funders (e.g., HRSA).'' Yet another comment expressed the need 
for additional guidance specific to Title X grantees and subrecipients 
operating under the Health Center Program, to assist with alignment of 
billing practices.
    Response: The Department fully supports minimizing administrative 
burden for grantees funded under both the Title X program and HRSA's 
Section 330 Health Center Program, recognizing that providers that 
dually participate in the two programs have been one of the fastest 
growing segments of the Title X provider network. Similar to the Health 
Center Program's statutory requirement that health centers must operate 
in a manner such that no patient shall be denied service due to an 
individual's inability to pay, the Department also believes, and the 
Title X statute requires, that an individual's ``economic status shall 
not be a deterrent to participation'' in Title X program services. See 
PHS Act sec. 1006(c). The Department does not believe that adding to 
this rule the commenter's suggested language with respect to the Health 
Center Program Compliance Manual is warranted as it is taken out of 
context and does not state the statutory requirement. The Department 
believes that adding language requested in the comments could hinder 
Title X clients who qualify for sliding fee discounts from receiving 
the discounts, which is contrary to Title X's mandate of prioritizing 
services to low-income clients. Further, OPA clarifies how Title X 
grantees may remain in compliance with Title X Program requirements 
when integrating services with HRSA's Health Center Program grantees 
and look-alikes in OPA Program Policy Notice: 2016-11: Integrating with 
Primary Care Providers.''
    Rather than revising the regulation and risk Title X clients not 
receiving all discounts for which they qualify, OPA will continue to 
work closely with HRSA to ease administrative burden for grantees 
funded under both programs. The Department will provide additional 
guidance and technical assistance to dually funded grantees aimed at 
reducing administrative burden. In conclusion, the Department adopts 
the language from the NPRM for Sec.  59.5(a)(8) as final without 
revisions.

Sec.  59.5(a)(9). Reasonable Measures To Verify Client Income

    In the NPRM, the Department proposed adding a new section 
59.5(a)(9) to include one requirement from the 2014 Title X Program 
Requirements that grantees take reasonable measures to verify client 
income, and a new requirement that grantees use client self-reported 
income if the income cannot be verified after reasonable attempts. The 
Department believes that these proposed revisions will greatly improve 
accessibility and affordability of services for low-income clients 
consistently across all Title X grantees.
    The NPRM text reads, ``Take reasonable measures to verify client 
income, without burdening clients from low-income families. Recipients 
that have lawful access to other valid means of income verification 
because of the client's participation in another program may use those 
data rather than re-verify income or rely solely on clients' self-
report. If a client's income cannot be verified after reasonable 
attempts to do so, charges are to be based on the client's self-
reported income.''
    Comments: The Department received several comments supporting the 
use of self-reported income. Comments received from members of the 
House of Representatives stated, ``[W]e support the Department's stance 
that patients be allowed to self-report their income, removing an 
unnecessary potential barrier to care.'' Other comments expressed 
support that ``cost should not be a barrier'' to receiving services. 
Still other reaffirmed support that allowing use of self-reported 
income ``will greatly improve accessibility and affordability for low-
income and uninsured patients seeking care from Title X program 
grantees.'' One comment felt that the provision did not go far enough 
and asked that the language ``explicitly state that a client's self-
reported income is sufficient, and that providers do not need to verify 
client income.''
    The Department also received several comments on this provision 
specifically seeking closer alignment between Title X and HRSA's Health 
Center Program (authorized by Section 330 of the PHS Act) to minimize 
administrative burden for dually funded grantees. Several comments felt 
that allowing a client's self-reported income in cases where a client's 
income cannot be verified despite reasonable attempts is inconsistent 
with the Health Center Program guidance. Comments reported that 
``health centers have broad discretion to determine the appropriate 
means to assess patient income and family size. While allowing self-
declaration is typical in the health center program, some health 
centers have opted to adopt a policy establishing that self-
declaration, without supporting documentation, is not an acceptable 
means to verify income for every patient.''
    Response: The Department appreciates the supportive comments and 
agrees that the requirements in this provision will greatly improve 
accessibility and affordability of services for low-income clients 
consistently across all Title X grantees. The elimination of barriers 
to Title X services for low-income clients is important to the Title X 
program. The Department disagrees that the requirements in 59.5(a)(9) 
are not compatible with HRSA's guidance. HRSA requires health centers 
to operate in a manner such that no patient shall be denied service due 
to an individual's inability to pay; further, HRSA Health Center 
Program grantees are required to establish systems for sliding fee 
scale eligibility that comply with statutory requirements under section 
330 of the PHS Act and regulatory requirements under 42 CFR 51c.303(f) 
and 56.303(f), which do not preclude self-declaration of income and 
family size. The Department believes that the HRSA Health Center 
Program requirements are fully consistent with the language in Sec.  
59.5(a)(9). A strict standard of income verification at a particular 
health center is a choice that does not warrant weakening a standard in 
Title X that the

[[Page 56161]]

Department has created to support and reinforce the program's statutory 
obligation to prioritize services to persons from low-income families. 
In conclusion, the Department adopts the language from the NPRM for 
Sec.  59.5(a)(9) as final without revisions.

Sec.  59.5(a)(12). State Reporting Laws

    In the NPRM, the Department proposed adding 59.5(a)(12) to retain 
some, but not all, language from the 2019 rule on notification or 
reporting of child abuse, child molestation, sexual abuse, rape, 
incest, intimate partner violence, or human trafficking. The NPRM 
language stated, ``Title X projects shall comply with all State and 
local laws requiring notification or reporting of child abuse, child 
molestation, sexual abuse, rape, incest, intimate partner violence or 
human trafficking (collectively, ``State notification laws''). Title X 
projects must provide appropriate documentation or other assurance 
satisfactory to the Secretary that it: (i) Has in place and implements 
a plan to comply with State notification laws. (ii) Provides timely and 
adequate annual training of all individuals (whether or not they are 
employees) serving clients for, or on behalf of, the project regarding 
State notification laws; policies and procedures of the Title X project 
and/or for providers with respect to notification and reporting of 
child abuse, child molestation, sexual abuse, rape, incest, intimate 
partner violence and human trafficking; appropriate interventions, 
strategies, and referrals to improve the safety and current situation 
of the patient; and compliance with State notification laws.''
    Comments: Many comments supported the elimination of section 59.17 
from the 2019 rule. Comments supported eliminating ``the 2019 rule's 
attempt to give HHS substantial oversight over compliance with complex 
state reporting requirements.'' Many comments noted that 
``professionals providing services in Title X-funded sites are aware of 
their reporting obligations, already receive training on them, and make 
reports in compliance with these requirements.'' Other comments 
stressed that determining compliance with state reporting laws lies 
with state authorities and noted that state reporting laws ``are 
complex and vary widely from state to state.''
    One comment written in opposition to the NPRM expressed that the 
NPRM excluded ``the mandatory reporting of sex trafficking and violence 
by intimate partners.'' Another comment requested that the 2019 Title X 
requirement for mandatory reporting be kept fully intact. Another 
comment expressed concern that the proposed rule did not include the 
minor age record-keeping requirements and made an assertion that 
``[t]his lack of record keeping serves to enable sex traffickers and 
abusers to continue undetected in their abuse.'' The comment proposed 
reinstatement of these requirements and further proposed rescinding the 
funding of any grant recipient who fails to screen for and report 
sexual abuse or sex trafficking.
    Response: The Department agrees with comments that all Title X 
recipients must follow state reporting laws and must comply with 
mandatory reporting requirements regarding child abuse, child 
molestation, sexual abuse, rape, or incest. The Department disagrees 
with the assertion that ``. . . lack of record keeping serves to enable 
sex traffickers and abusers to continue undetected in their abuse.'' 
States have already established specific guidelines on the details that 
must be included in mandatory reports. As such, the Department believes 
that it is not necessary to impose this additional reporting burden 
through Title X regulations.
    Since 1999, Congress has required, through the annual 
appropriations bill that, ``[n]otwithstanding any other provision of 
law, no provider of services under Title X of the PHS Act shall be 
exempt from any State law requiring notification or the reporting of 
child abuse, child molestation, sexual abuse, rape, or incest.'' All 
requirements in the appropriations riders are legislative mandates for 
the Title X program and all Title X grantees must comply with them. The 
Department will continue to enforce and monitor grantee compliance with 
all Title X statutory requirements and legislative mandates, including 
the mandate that ``no provider of services under Title X of the PHS Act 
shall be exempt from any State law requiring notification or the 
reporting of child abuse, child molestation, sexual abuse, rape, or 
incest.''
    As noted above with respect to Section II. C. Grantee and 
Subrecipient Compliance, OPA explicitly states in NOFOs that all Title 
X grantees must comply with the Title X statute, regulations, and 
legislative mandates. In addition, Title X applicants certify in the 
application materials that they will comply with federal law, and 
compliance with federal law, and 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. OPA has consistently documented compliance with this 
mandated requirement and will continue to do so. A 2005 OIG report 
(OEI-02-03-00530) found that OPA has informed and periodically reminded 
Title X grantees of their responsibilities regarding state child-abuse 
and sexual-abuse reporting requirements.
    Given the comments received and that Title X compliance with state 
mandatory reporting is already required through a legislative mandate 
for the Title X program, the Department does not deem it necessary to 
include this provision within the final regulation itself. Furthermore, 
this provision was a part of the 2019 rule that is being rescinded as a 
whole because it was a set of interrelated requirements that did not 
promote the public health or solve any Title X compliance concerns. In 
conclusion, the Department removes language from the NPRM for Sec.  
59.5(a)(12) from the 2021 final rule.

Sec.  59.5(a)(13). Subrecipient Monitoring

    In the NPRM, the Department proposed adding 59.5(a)(13) to retain 
some, but not all, of the language from the 2019 rule related to 
subrecipient monitoring and reporting. This addition required Title X 
grantees to report on the subrecipients and referral agencies involved 
in their Title X projects and to provide their plan for oversight and 
monitoring of their subrecipients in grantee reports.
    The NPRM language stated, ``Ensure transparency in the delivery of 
services by reporting the following information in grant applications 
and all required reports: (i) Subrecipients and agencies or individuals 
providing referral services and the services to be provided; (ii) 
Description of the extent of the collaboration with subrecipients, 
referral agencies, and any individuals providing referral services, in 
order to demonstrate a seamless continuum of care for clients; and 
(iii) Explanation of how the recipient will ensure adequate oversight 
and accountability for quality and effectiveness of outcomes among 
subrecipients.''
    Comments: The Department received several comments expressing 
concerns with the requirements of this provision and the high reporting 
burden associated with it. One comment requested that section Sec.  
59.5(a)(13) be

[[Page 56162]]

removed completely because of the additional reporting requirements it 
creates. Another comment requested that the Department only require 
grantees to submit the additional information required by this 
provision for subrecipients during regular reports but not during the 
initial application. The comment expressed a concern that for large 
Title X networks, ``providing a description of all referral agencies 
and individuals, and outlining collaborations with each subrecipient, 
will still pose a significant burden for Title X grantees, particularly 
at the time of application when applicants are often afforded 60 days 
or less to apply.'' Many other comments requested that the Department 
revise the language in this provision to focus only on subrecipients 
and not referral agencies ``due to high burden'' of reporting given the 
size of grantee networks and the high number of possible referrals made 
by individual sites. One comment stressed that ``under the 2000 
regulations, past grantees were required to monitor each organization 
and ensure that their clinic sites had appropriate referrals, that they 
were available to all clinic personnel, and that clients' medical 
charts reflected appropriate referrals given and follow-up performed. 
However, grantees were not required to gather every referral source and 
report this information to HHS. This requirement will likely create an 
administrative burden that could be accomplished through HHS monitoring 
of grantees.''
    Response: It is clear from the comments received that the proposed 
requirements in Sec.  59.5(a)(13) are unnecessarily burdensome for 
grantees and will result in Title X staff having to spend valuable time 
on administrative reporting that could otherwise be spent providing 
services to clients. The Department agrees that monitoring how grantees 
are involving and monitoring their subrecipients in their project and 
the composition of grantee referral networks can be achieved through 
the Department's existing grantee compliance monitoring system. 
Departmental grants regulations at 45 CFR 75.352 already document the 
requirements for pass-through entities and specify the reporting 
required of grantees for all pass-through entities. Furthermore, this 
provision was a part of the 2019 rule that is being rescinded as a 
whole because it was a set of interrelated requirements that did not 
promote the public health or solve any Title X compliance concerns.
    Given the challenges noted with this provision and the additional 
reporting burden it would place on grantees, the Department has decided 
to remove Sec.  59.5(a)(13) from the 2021 final rule.

Sec.  59.5(b)(1) Provide Medical Services Related to Family Planning

    In the NPRM, the Department proposed revising section 59.5(b)(1) of 
the 2000 regulations to acknowledge that consultation for medical 
services related to family planning can be provided by healthcare 
providers beyond the physician. Specifically, the NPRM stated, 
``Provide for medical services related to family planning (including 
consultation by a healthcare provider, examination, prescription, and 
continuing supervision, laboratory examination, contraceptive supplies) 
and necessary referral to other medical facilities when medically 
indicated, and provide for the effective usage of contraceptive devices 
and practices.'' The proposed revision acknowledged that consultation 
for healthcare services related to family planning may be by a 
physician, but may also be by other healthcare providers, specifically 
acknowledging participation by physician assistants and nurse 
practitioners.
    Comments: The Department received numerous comments supporting this 
revised provision, specifically in support of the recognition that a 
broad range of healthcare providers, in addition to physicians, have an 
important role to play in providing medical services related to family 
planning. Comments expressed agreement that ``other clinicians often 
play an important role in providing family planning counseling and 
other services.'' In addition, numerous comments asked the Department 
to clarify that this provision includes a broader range of healthcare 
providers beyond just physician assistants and nurse practitioners, as 
noted in the preamble of the NPRM. One comment asked that the 
Department use the definition of Clinical Services Provider from FPAR. 
Many other comments stated that ``it is important to note that 
`consultation by a [healthcare] provider' is not and should not be 
limited only to the examples cited by HHS, as these CSPs represent only 
one facet of healthcare providers in Title X settings.''
    In addition to the numerous comments related to the array of 
healthcare professionals that are responsible for clinical service 
provision in Title X, the Department also received numerous comments 
asking for the language of this provision to be revised to clearly 
reflect telehealth as an acceptable service delivery modality. Several 
comments expressed the importance of telehealth, especially throughout 
the COVID-19 pandemic, in allowing many Title X clients to continue to 
safely access essential services. Many comments expressed concern with 
the Department's use of the word ``telemedicine'' in the NPRM instead 
of ``telehealth'' and felt that telehealth refers ``to a broader scope 
of remote healthcare services than telemedicine and includes non-
clinical services like counseling and education.'' Several comments 
specifically asked the Department to revise Sec.  59.5(b)(1) to be 
clear within the regulation that family planning services can be 
provided ``in person or via telehealth.'' Other comments asked the 
Department to specify within the regulation that telehealth services 
can include ``audio-only modalities'' and expressed that ``all forms of 
telehealth modalities, including audio-only must be covered to remove 
any barriers of access for patients.'' One comment asked the Department 
to provide guidance to Title X grantees on how to use telehealth 
services to ensure access, equity, and quality.
    Response: The Department appreciates the comments in support of 
this provision, especially those that recognize the role of a broader 
range of healthcare providers in delivering family planning services. 
It was never the Department's intention to imply that the only 
healthcare providers who could provide consultation under this 
provision were physician assistants and nurse practitioners. Physician 
assistants and nurse practitioners were included in the NPRM preamble 
to provide examples, but not to be exclusionary. The Department agrees 
with comments recommending use of the definition of Clinical Services 
Providers from FPAR to determine who is eligible as a healthcare 
provider under this provision and, as noted in the discussion related 
to Section 59.2 Definitions, is adding this definition to the final 
rule. The FPAR definition for Clinical Services Providers includes 
``physicians, physician assistants, nurse practitioners, certified 
nurse midwives, and registered nurses with an expanded scope of 
practice who are trained and permitted by state-specific regulations to 
perform all aspects of the user (male and female) physical assessments 
recommended for contraceptive, related preventive health, and basic 
infertility care.''
    The Department agrees with the comments reiterating the importance 
of telehealth and the role of telehealth services in expanding access 
to services and advancing equity. The Department had always intended 
for the final rule to apply to family planning services

[[Page 56163]]

provided in-person or via telehealth and had specifically stated in the 
NPRM that the Department was ``readopting the 2000 regulations with 
revisions that will enhance the Title X program and its family planning 
services, including family planning services provided using 
telemedicine, for the future.'' Telehealth has played a critical role 
for Title X in responding to the COVID-19 pandemic. By utilizing 
telehealth modalities, Title X grantees were able to continue to 
provide essential family planning services throughout the pandemic. 
With the onset of COVID-19, the vast majority of Title X grantees 
transitioned to some form of telehealth service delivery in order to 
continue providing services while limiting contact between individuals 
and protecting client safety. Telehealth was commonly used by Title X 
grantees for non-urgent visits that did not require a physical exam. Of 
importance, more than half of the grantees that were able to deliver 
telehealth during COVID-19 reported to OPA in their progress reports 
that they intended to continue offering telehealth services even after 
the pandemic ends, due to the advantages for both clients and staff.
    Given the comments received, the Department believes that it is 
important to include language specifically in the regulatory text to 
clarify that telehealth services also constitute appropriate service 
delivery. The Department also agrees with the request to use the term 
``telehealth'' rather than ``telemedicine'' to be clear that telehealth 
services include non-clinical services like counseling and education. 
While cognizant that synchronous telehealth services may be delivered 
through different modes of technology and that audio-only modalities 
may mitigate access barriers, particularly for those with limited 
internet and/or cellular data, the Department does not agree that the 
regulatory text needs to be so specific to reference the use of 
``audio-only modalities,'' especially given how rapidly technology can 
change. Instead, the Department will provide additional training and 
technical assistance to grantees on the use of various telehealth 
modalities to improve access, quality, and equity.
    With the revisions noted above, the revised language of 59.5(b)(1) 
for the 2021 rule is, ``Provide for medical services related to family 
planning (including consultation by a clinical services provider, 
examination, prescription, and continuing supervision, laboratory 
examination, contraceptive supplies), in person or via telehealth, and 
necessary referral to other medical facilities when medically 
indicated, and provide for the effective usage of contraceptive devices 
and practices.'' This revised language for Sec.  59.5(b)(1) is adopted 
as final.

Sec.  59.5(b)(3) Community Education, Participation, and Engagement

    In the NPRM, the Department proposed revising section 59.5(b)(3) of 
the 2000 regulations to reflect the desire to engage diverse 
individuals to make services accessible. Specifically, the NPRM stated, 
``Provide for opportunities for community education, participation, and 
engagement to: (i) Achieve community understanding of the objectives of 
the program; (ii) Inform the community of the availability of services; 
and (iii) Promote continued participation in the project by diverse 
persons to whom family planning services may be beneficial to ensure 
access to equitable, affordable, client-centered, quality family 
planning services.'' The revision added language to clarify the intent 
to engage diverse individuals to ensure access to equitable, 
affordable, client-centered, quality family planning services.
    Comments: The Department received one comment expressing support 
for 59.5(b)(3), especially emphasizing the importance of the 
participation and engagement of diverse individuals in making family 
planning services accessible, equitable, and client-centered. The 
Department received one comment asking that the language of 59.5(b)(3) 
be revised to ``be clear that the needs of adolescents and young 
adults'' are included in community education, participation, and 
engagement.
    Response: The Department appreciates the comments in response to 
this provision. Community education, participation, and engagement are 
important for Title X projects because they help ensure that the 
community is aware of the Title X program and the services available. 
In addition, community participation and engagement are critical to 
helping Title X providers better understand and center the needs and 
experiences of the community and the clients served. Together, 
community education, participation, and engagement are foundational for 
ensuring access, equity, and quality through the provision of Title X 
services.
    In response to the one comment requesting a revision to the 
provision, the Department believes that the proposed regulatory text is 
broad and already includes the needs of adolescents and young adults as 
currently written. The Department does not believe that additional 
revisions are needed to the regulatory text in order to respond to the 
comment received. In conclusion, the Department adopts the language 
from the NPRM for Sec.  59.5(b)(3) as final without revisions.

59.5(b)(6) Services Under Direction of Clinical Services Provider

    The NPRM proposed the same regulatory text for this provision as 
has been included in the 2000 regulations, which read, ``Provide that 
family planning medical services will be performed under the direction 
of a physician with special training or experience in family 
planning.''
    Comments: The Department received numerous comments requesting 
revisions to the regulatory text for this provision. Comments requested 
that the regulation expand beyond physician-only directed services. 
Several comments requested that the text be revised to be consistent 
with the revisions to Sec.  59.5(b)(1), which recognized the importance 
of a broader range of healthcare providers, in addition to physicians, 
in providing family planning services. Several comments requested 
revisions to expand direction of family planning services to very 
specific types of healthcare providers. One comment asked that the 
language clarify that nurse practitioners have the authority to direct 
family planning programs. Another comment asked that the language be 
revised from physician to ``licensed healthcare provider.'' Still 
another asked that this section be revised to specifically authorize 
physician assistants to direct family planning services.
    Several other comments were specific to advanced practice 
registered nurses (APRNs) and asked that the language specify that 
APRNs ``be able to serve as the medical director (in states with full 
practice authority).'' One commenter pointed out that ``while state 
licensure rules vary, many states have granted full practice authority 
to APRNs, enabling independent practice.'' Another comment requested 
that the Department consider whether registered nurses could direct 
family planning services ``especially in areas of provider shortage.'' 
A final comment asked for the text to be amended to allow services 
provided ``under the direction of an advanced practice clinician, if 
the services offered are within their scope of practice and if 
allowable under state law.''
    Response: Given the comments received, the Department agrees that 
having consistency between 59.5(b)(1) and 59.5(b)(6) is important to 
more clearly reflect the role of a broader range of healthcare 
providers in providing

[[Page 56164]]

Title X services. The Department also agrees with comments that other 
healthcare providers, including physician assistants and APRNs in many 
states, have authority to direct family planning programs and should be 
included within the regulation.
    As stated earlier, the Department received comments in response to 
59.5(b)(1) asking for more clarity on the term ``healthcare providers'' 
included in the NPRM, with many comments recommending use of the term 
``clinical services provider'' as defined by OPA in FPAR. As a result, 
the Department has revised the final language for 59.5(b)(1) to use the 
term ``clinical services provider'' instead of ``healthcare provider'' 
and has revised 59.2 to include the FPAR definition of ``clinical 
services provider'' in the regulatory text. The FPAR definition for 
clinical services provider includes ``physicians, physician assistants, 
nurse practitioners, certified nurse midwives, and registered nurses 
with an expanded scope of practice who are trained and permitted by 
state-specific regulations to perform all aspects of the user (male and 
female) physical assessments recommended for contraceptive, related 
preventive health, and basic infertility care.''
    To ensure consistency between 59.5(b)(1) and 59.5(b)(6) as 
requested in the public comments, the Department has revised the 
language for the 2021 rule for 59.5(b)(6) to, ``Provide that family 
planning medical services will be performed under the direction of a 
clinical services provider, with services offered within their scope of 
practice and allowable under state law, and with special training or 
experience in family planning.'' This revised language for Sec.  
59.5(b)(6) is adopted as final.

59.5(b)(8) Coordination and Use of Referrals and Linkages

    In the NPRM, the Department proposed revising section 59.5(b)(8) of 
the 2000 regulations to add language to include primary healthcare 
providers in the list of referrals and to state that referrals are to 
be to providers in close proximity to the Title X site when feasible. 
The NPRM stated, ``Provide for coordination and use of referrals and 
linkages with primary healthcare providers, other providers of 
healthcare services, local health and welfare departments, hospitals, 
voluntary agencies, and health services projects supported by other 
federal programs who are in close physical proximity to the Title X 
site, when feasible, in order to promote access to services and provide 
a seamless continuum of care.''
    Comments: The Department received several comments expressing 
support for revising the provision to include primary healthcare 
providers in the list of referrals and to require that referrals be to 
nearby providers, when feasible. One comment expressed support and said 
that ``referring Title X patients to local primary care physicians 
would facilitate access to continuous, comprehensive healthcare.'' 
Several other comments expressed support and stressed the existing 
collaborative relationships between many HRSA-funded health centers and 
Title X sites. Comments expressed that ``referral relationships allow 
the health center and the Title X site to become more familiar with one 
another's operations and service lines, often serving as a useful 
precursor to a more integral relationship in the future.''
    Response: The Department appreciates the many supportive comments 
in response to this revised provision. The Department agrees that it is 
important for Title X clinics to provide referrals and linkages to a 
wide range of healthcare services to help facilitate access for Title X 
clients to needed healthcare services beyond family planning. Given 
that the Department received no comments expressing concern with or 
opposition to the proposed modification, the Department adopts the 
language from the NPRM for Sec.  59.5(b)(8) as final without revisions.

Sec.  59.6 Suitability of Informational and Educational Material

    In the NPRM, the Department proposed revising the 2000 regulations 
by combining requirements specific to the Information and Education 
Advisory Committee (``Advisory Committee'') that were in sections 
59.5(a)(11) and 59.6 and consolidating all of the Advisory Committee 
information in one place, under section 59.6. The NPRM proposed several 
revisions to 59.6 to clarify that the regulation applies to both print 
and electronic materials (in both the title of the section and 
regulatory text), that the upper limit on council members should be 
determined by the grantee, that the factors to be considered for broad 
representation on the Advisory Committee match the definition of 
inclusivity earlier in the regulation, and that materials will be 
reviewed for medical accuracy, cultural and linguistic appropriateness, 
and inclusivity and to ensure they are trauma-informed.
    Specifically, the NPRM states:
    ``(a) A grant under this section may be made only upon assurance 
satisfactory to the Secretary that the project shall provide for the 
review and approval of informational and educational materials (print 
and electronic) developed or made available under the project by an 
Advisory Committee prior to their distribution, to assure that the 
materials are suitable for the population or community to which they 
are to be made available and the purposes of Title X of the Act. The 
project shall not disseminate any such materials which are not approved 
by the Advisory Committee.
    (b) The Advisory Committee referred to in paragraph (a) of this 
section shall be established as follows:
    (1) Size. The Committee shall consist of no fewer than five members 
and up to as many members as the recipient determines, except that this 
provision may be waived by the Secretary for good cause shown.
    (2) Composition. The Committee shall include individuals broadly 
representative of the population or community for which the materials 
are intended (in terms of demographic factors such as race, ethnicity, 
color, national origin, disability, sex, sexual orientation, gender 
identity, age, marital status, income, geography, and including but not 
limited to individuals who belong to underserved communities, such as 
Black, Latino, and Indigenous and Native American persons, Asian 
Americans and Pacific Islanders and other persons of color; members of 
religious minorities; lesbian, gay, bisexual, transgender, and queer 
(LGBTQ+) persons; persons with disabilities; persons who live in rural 
areas; and persons otherwise adversely affected by persistent poverty 
or inequality).
    (3) Function. In reviewing materials, the Advisory Committee shall:
    (i) Consider the educational, cultural, and diverse backgrounds of 
individuals to whom the materials are addressed;
    (ii) Consider the standards of the population or community to be 
served with respect to such materials;
    (ii) Review the content of the material to assure that the 
information is factually correct, medically accurate, culturally and 
linguistically appropriate, inclusive, and trauma-informed;
    (iii) Determine whether the material is suitable for the population 
or community to which is to be made available; and
    (iv) Establish a written record of its determinations.''
    Comments: The Department received one comment in support of the 
proposed revisions that expressed that ``this will ensure that 
information and materials provided to clients are appropriate and 
suitable for the specific communities to be served.'' Another

[[Page 56165]]

comment shared specific support for the requirement that grantees 
provide ``culturally and linguistically appropriate'' materials. One 
comment opposed to this provision expressed that the language in 59.6 
``remains overly narrow and prescriptive'' and recommended that the 
language be revised to require ``a Community Advisory Board charged 
with a broad array of responsibilities to ensure the appropriateness of 
Title X services for intended communities.'' Another comment opposed 
``underrepresented communities'' in composition of the advisory council 
and claimed that ``to the extent it results in segregation or 
prioritization of Title X services or committee membership by protected 
classes such as race, it violates the Constitution and several civil 
rights laws.'' This same comment also opposed having the advisory 
committee review materials to certify that they are trauma-informed and 
inclusive.
    Response: The Department appreciates the supportive comment in 
response to this provision. The role of the Advisory Committee is 
critically important to ensure that the information and educational 
materials provided to Title X clients are factually correct, medically 
accurate, culturally and linguistically appropriate, inclusive, and 
trauma-informed. Engaging the community and population served in the 
Advisory Committee itself is a key strategy to inform the grantee about 
the needs and experiences of the community and population served, and 
to make sure that the information and education materials are 
appropriate for the community and population served.
    The Department disagrees with the comment that the language in 59.6 
is too narrow and prescriptive. The Department believes that the 
requirements set forth in 59.6 are critical for ensuring that 
informational and educational materials provided to Title X clients are 
factually correct, medically accurate, culturally and linguistically 
appropriate, inclusive, and trauma-informed. In addition, the Title X 
statute prescribes requirements related to the informational and 
educational materials developed or made available under the project, 
including that they ``will be suitable for the purposes of [Title X] 
and for the population or community to which they are to be made 
available, taking into account educational and cultural background of 
the individuals to whom such materials are addressed and the standards 
of such population or community with respect to such materials'' (PHS 
Act sec. 1006(d)(1)), and also prescribes requirements related to the 
Advisory Committee, including that the ``committee shall include 
individuals broadly representative of the population or community to 
which the materials are to be made available'' (PHS Act sec. 
1006(d)(2)).
    The Department also disagrees with the comment that the regulation 
is segregating or prioritizing services or committee members. The text 
of the provision calls for the Committee membership to include 
``individuals broadly representative of the population or community for 
which the materials are intended. . . . Including but not limited to 
individuals who belong to underserved communities.'' Since all 
communities served are different, the aim of this provision is to 
ensure the committee is representative of the community and population 
served, as required by the statute. The Department disagrees with the 
opposition to having the Advisory Committee review materials to ensure 
they are inclusive and trauma-informed. Providing information and 
educational materials that are inclusive and trauma-informed are a 
critical component of providing quality, client-centered care.
    The Department does not believe that revisions are needed to the 
regulatory text included in the NPRM. As a result, the Department 
adopts the language from the NPRM for Sec.  59.6 as final with a 
technical correction to include ``sex characteristics''.

Sec.  59.7 Grant Review Criteria

    In the NPRM, the Department proposed revising section 59.7 of the 
2000 regulations to add one additional review criterion that the 
Department may consider in deciding which family planning projects to 
fund and in what amount, which is ``the ability of the applicant to 
advance health equity.'' Adding this new criterion to the 2000 
regulations brings the total number of grant review criteria specified 
in the regulation from seven to eight. Advancing health equity is 
critical to the mission of the Title X program. The addition of this 
grant review criterion will help ensure that grant funds are awarded to 
those applicants who are best able to help the Department in achieving 
the goal of advancing health equity through the Title X program.
    Comments: The Department received several comments in response to 
this revised provision asking for additional details in future funding 
opportunities about what the new criterion means and how it will be 
measured. One comment provided specific examples of how the Department 
could operationalize the new grant review criterion. Another comment 
asked the Department to ``develop additional guidance and tools that 
Title X sites and other healthcare organizations can readily 
implement'' to meaningfully advance health equity. Still another 
comment expressed concern that the NPRM did not include an explanation 
``for how a Title X project can, in fact, ensure equity in general and 
specifically in a way that does not lead to actual discrimination based 
on a protected basis.''
    Response: The Department appreciates the comments and 
recommendations received. The grant review criteria from the 2000 
regulation include several criteria aimed at assessing the need, 
capacity, and ability of the applicant organization, including the 
relative need of the applicant, the capacity of the applicant to make 
rapid and effective use of the federal assistance, the adequacy of the 
applicant's facilities and staff, the relative availability of non-
federal resources within the community to be served and the degree to 
which those resources are committed to the project, and the degree to 
which the project plan adequately provides for the requirements set 
forth in these regulations. In addition, the grant review criteria from 
the 2000 regulation include two criteria aimed at assessing need in the 
communities served, including the number of clients, and, in 
particular, the number of low-income clients to be served; and the 
extent to which family planning services are needed locally.
    The Department believes that adding the new grant review criterion 
to assess the ability of the applicant to advance health equity is 
important to enable OPA to more fully assess the extent to which the 
applicant's project will promote health equity through the Title X 
services provided. Under 59.2, health equity is defined as ``when every 
person has the opportunity to attain their full health potential and no 
one is disadvantaged from achieving this potential because of social 
position or other socially determined circumstances.''
    Adding a focus on advancing health equity will not lead to 
discrimination or preferential treatment as expressed by some comments 
opposed to the NPRM. Rather, including a focus on advancing health 
equity aims to ensure that all people can actively participate in and 
benefit from family planning services. By advancing equity across the 
federal government, we can create opportunities for the improvement of 
communities that have been historically underserved, which benefits 
everyone. The federal government's goal in advancing equity is to 
provide everyone

[[Page 56166]]

with the opportunity to reach their full potential.
    To measure the ability of an applicant to advance health equity, 
OPA could assess how the location of planned Title X service sites 
compares to the need for family planning services within the 
communities served. OPA also could assess how the applicant plans to 
provide services in a manner that is culturally and linguistically 
appropriate. OPA could assess how the project plans to monitor outcomes 
by clients' income, race, ethnicity, geographic location, etc., as well 
as how the project plans to address differences in outcomes through the 
Title X services provided. OPA could also ask applicants to describe 
the uptake of services by client demographics to identify existing 
disparities and to describe how they would work to reduce existing 
disparities in service provision. In addition, some agencies within the 
Department have incorporated disparity impact statements as a part of 
the post-grant award process. Disparity impact statements are just one 
example of a tool that OPA may consider in order to measure 
demographic, cultural, and linguistic data that identify the 
population(s) in which health disparities exist and the quality 
improvement plan designed to address the noted disparities. These are 
just examples of how this new grant review criterion could be 
operationalized within future NOFOs.
    The Department will provide details on how all grant review 
criteria will be measured in future NOFOs, including the new grant 
review criterion on advancing health equity. The Department also plans 
to develop training and technical assistance products to assist family 
planning providers in advancing health equity.
    In conclusion, the Department adopts the language from the NPRM for 
Sec.  59.7 as final with one technical correction to replace ``his 
estimate'' with ``an estimate'' to reflect inclusive language.

Sec.  59.10. Confidentiality

    In the NPRM, the Department proposed revising the provision of the 
2000 regulations related to confidentiality, which was section 59.11 in 
the 2000 regulations, but is now section 59.10, to add a widely 
accepted practice in the Title X community, indicating that reasonable 
efforts must be made to collect charges without jeopardizing client 
confidentiality. In addition, the Department proposed adding a 
requirement that grantees 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. Since state 
and local laws may vary across jurisdictions (e.g., some are likely to 
result in notification to the policyholder that the client has received 
services, others provide for an ``opt out'' process whereby the client 
can elect that such a notification will not be made), this addition was 
added to ensure that the client understands the implications for using 
their insurance and the options available for them to maintain 
confidentiality.
    Specifically, the NPRM stated, ``All information as to personal 
facts and circumstances obtained by the project staff about individuals 
receiving services must be held confidential and must not be disclosed 
without the individual's 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.''
    Comments: The Department received numerous comments in support of 
this provision and the proposed revisions. Many comments expressed 
support for restoring ``the confidentiality protections that have been 
a hallmark of the Title X program.'' Several comments expressed support 
for allowing ``providers to return to the high standard of 
confidentiality that all patients, including adolescents, deserve when 
accessing healthcare services, especially ones as potentially sensitive 
as family planning and sexual health.'' Several comments also 
specifically supported the new language on potential disclosure to 
policyholders.
    The Department also received numerous comments requesting further 
revisions to the regulatory text for 59.10. Numerous comments urged the 
Department to add language to the regulatory text to clarify that 
``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.''
    Comments underscored that this language has been longstanding 
guidance from OPA for the Title X program and is included in OPA 
Program Policy Notice 2014-01: Confidential Services to Adolescents. 
One comment stated, ``We encourage you to take all possible steps when 
finalizing the rule to ensure that adolescents are treated with the 
same client-centered approach as all other patients at Title X-funded 
health centers.'' In addition, many comments generally opposed the 
removal of language from the regulation that encouraged family 
participation in the decision of a minor patient to seek family 
planning services and requested that the language be added back into 
the final regulation.
    Several other comments expressed concern with a new rule from the 
HHS Office of the National Coordinator for Health Information 
Technology (ONC) about Electronic Health Records and information 
blocking. Several comments requested that the Department confirm in the 
final rule that withholding of sensitive information in compliance with 
59.10 would ``fall within the ONC rule's privacy exception and would 
not constitute information blocking.''
    Response: The Department appreciates the comments in support of the 
revised provision in the NPRM. The Department agrees with comments to 
add specific language to the final rule regarding adolescent 
confidentiality to reflect Title X legal requirements. Since 1981, the 
Title X statute has required that, ``to the extent practical, 
[grantees] shall encourage family participation'' in Title X projects. 
42 U.S.C. 300(a). However, such involvement is not mandatory and 
grantees are required to protect clients' confidentiality. Specifically 
with respect to adolescents, courts have for decades recognized minors' 
rights to receive confidential services under the Title X program. See, 
e.g., Planned Parenthood Federation of America, Inc. v. Heckler, 712 
F.2d 650 (D.C. Cir., 1983) (Title X expressly protects minors' rights 
to seek services confidentially). See also OPA Program Policy Notice 
2014-01: Confidential Services to Adolescents.
    The Department does not agree that specific language needs to be 
added to the final rule to clarify the applicability of the ONC rule to 
Title X. Instead, as described below related to section 59.12, OPA 
suggests that grantees seek guidance from ONC with respect to the 
applicability of the information-blocking provision, as ONC administers 
this rule and, thus, would be in the best position to interpret it. 
With this revision, the final language in the 2021 rule for 59.10 is, 
``(a) All information as to personal facts and circumstances obtained 
by the project staff about

[[Page 56167]]

individuals receiving services must be held confidential and must not 
be disclosed without the individual's 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.
---------------------------------------------------------------------------

    \12\ 42 U.S.C. 300(a) states: ``To the extent practical, 
entities which receive grants or contracts under this subsection 
shall encourage family participation in projects assisted under this 
subsection.''
---------------------------------------------------------------------------

    This revised language for Sec.  59.10 is adopted as final.

Sec.  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 faith-based 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 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 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. 
601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). 
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

[[Page 56168]]

administrative burdens for grantees of all sizes. Therefore, the 
Secretary certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities under the 
Regulatory Flexibility Act, 5 U.S.C. 605.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded 
Mandates Act) (2 U.S.C. 1532) requires the Department to prepare a 
written statement, which includes an assessment of anticipated costs 
and benefits, before proposing ``any rule that includes any Federal 
mandate that may result in the expenditure by State, local, and tribal 
governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $158 
million, using the most current (2020) Implicit Price Deflator for the 
Gross Domestic Product. This final rule will not result in an 
expenditure in any year that meets or exceeds this amount.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a rule that imposes substantial 
direct requirement costs on state and local governments or has 
federalism implications. The final rule will not have a significant 
impact on state funds as, by law, project grants must be funded with at 
least 90 percent federal funds. 42 U.S.C. 300a-4(a). The Department has 
determined that this final rule does not impose such costs or have any 
federalism implications. The Department expects that while some states 
may not support the policies contained in this final rule, many states 
and local health departments will support the policies contained in 
this final rule, and that it will increase participation by states 
(many of which withdrew as a result of the 2019 rule).

B. Summary of Costs, Benefits and Transfers

    This final rule will revise the regulations that govern the Title X 
family planning services program by revoking the 2019 rule and 
readopting the 2000 regulations with several modifications. This 
approach will allow the Title X program grantees, subrecipients, and 
service sites to have a greater impact on public health than under the 
current regulatory approach.
    We predict that this final rule will increase the number of 
grantees receiving Title X funds. In turn, the additional service sites 
supported by funding will result in additional clients served under the 
program. These clients receive access to contraception, and public 
health screening including clinical breast exams, Papanicolau (Pap) 
testing, and testing for STIs. These services result in improved family 
planning and birth spacing, earlier detection of breast and cervical 
cancer, and earlier detection of sexually transmitted infections 
including chlamydia, gonorrhea, syphilis, and human immunodeficiency 
virus (HIV), all of which correlate to net savings for the government. 
This screening and testing can result in significant cost savings from 
earlier treatment and other interventions. This final rule will also 
increase the diversity of grantees receiving funds, including 
geographic diversity to states that do not currently have a Title X 
grantee.
    The final rule will also focus grantees on providing services in a 
manner that is client-centered, culturally and linguistically 
appropriate, inclusive, and trauma-informed; protects the dignity of 
the individual; and ensures equitable and quality service delivery. 
This focus is especially important for the Title X program that 
prioritizes services for low-income clients.
    This regulatory impact analysis reports the activity occurring at 
Title X-funded sites to provide policymakers with this information. 
However, the direct impact within the program does not account for 
services that continue to be provided at sites not receiving Title X 
funding, filling the gap left by providers that withdrew from the 
program following the restrictions placed on funding included in the 
2019 rule.

C. Comments on the Preliminary Economic Analysis and Our Responses

    On April 15, 2021, the Department issued a proposed rule to revise 
regulations relating to the Title X program. The Department prepared a 
preliminary regulatory impact analysis (PRIA) for the proposed rule. 
Many comments were outside the scope of this rule. The paragraphs below 
describe and respond to the comments received on the PRIA.
    Summary of comments addressing the PRIA that were generally opposed 
to the rulemaking:
    Several of the comments suggested that the Department used flawed 
data in its forecasts or failed to account for COVID-19 in the PRIA. 
Several of the comments suggested that the Department does not have 
data to assess the effect of the 2019 rule, arguing that COVID-19 is a 
complicating factor. Several comments noted that clients served under 
the Title X program declined between 2009 and 2018, suggesting long-
term trends can account for some of the reduction in clients served 
under the 2019 rule. Other comments noted that long-term demographics 
trends are responsible for the decline in services, such as rise in 
median household income, rise in individuals with private insurance, 
and more diverse options available in the healthcare market.
    Several of the comments suggested that grantees withdrawing from 
the program may not have resulted in a decline in services, and that 
some services were continued with state and private funds. Several 
comments pointed out that some states saw an increase in clients after 
the 2019 rule. One comment argued that, when one of two Ohio grantees 
left the program, the remaining grantee prevented a gap in coverage.
    Responses to comments addressing the PRIA that were generally 
opposed to the rulemaking:
    The primary estimate of the baseline Title X service grantees, 
subrecipients, service sites, and clients served are derived from 
calendar year 2019 figures, which predate COVID-19. The PRIA's estimate 
of the likely effect of the proposed rule is to gradually return to the 
level of grantees, subrecipients, service sites, and clients that the 
program supported in calendar years 2016 to 2018, which also predates 
COVID-19. COVID-19 may complicate attempts to precisely estimate the 
magnitude of the effect of the 2019 rule on the Title X program, but 
pre-pandemic data from calendar year 2019 preceding COVID-19 reveals a 
significant drop-off in grantees, subrecipients, service sites, and 
clients supported by the program, which are contrary to the predictions 
in the 2019 rule.\13\ The Department acknowledges the uncertainty in 
the forecast of the baseline scenario of no regulatory action by 
including a sensitivity analysis in the PRIA. The upper-bound forecast 
of 3,095,666 clients served annually by the Title X program under the 
baseline scenario of the 2019 rule is well below the approximately 4 
million clients served during calendar years 2016 to 2018.
---------------------------------------------------------------------------

    \13\ If adjustment to the requirements of the 2019 rule took 
time for grantees and prospective new grantees (and possibly 
continues to do so), then immediate post-issuance difficulties in 
obligating Title X funds could ease over the years, which would in 
turn lead to a trend back toward pre-2019 Title X service levels 
even in the analytic baseline. However, the effects of the COVID-19 
pandemic would obscure, in the available data, whether such trends 
are present or absent.
---------------------------------------------------------------------------

    The Department disagrees with the suggestion that long-term trends 
drove the reduction in clients served under the 2019 rule. Between 
calendar years

[[Page 56169]]

2009 and 2014, the number of clients reported served by the Title X 
program declined from 5.2 million to 4.1 million, with an average 
annual decline in clients served by about 211 thousand per year. 
Between calendar years 2014 and 2018, the number of clients served fell 
more gradually, with an average annual decline in clients served of 
about 48 thousand per year. In calendar year 2019, the number of 
clients served fell by about 844 thousand. The Department believes it 
is appropriate to attribute the bulk of the reduction in clients served 
during calendar year 2019 to the 2019 rule.
    The Department agrees with the comments that state and private 
funding likely averted some of the public health consequences that 
would have otherwise occurred in the immediate time period following 
implementation of the 2019 rule. The Department acknowledged this 
limitation in the PRIA and noted that one effect of the proposed rule 
would be ``transfers (for example, if Title X newly funds medical 
services that would, in the absence of the proposed rule, be provided 
by charitable organizations or other private payers).'' The Department 
noted that several states contributed emergency or one-time funds. It 
is not clear whether state or private funding will be available for the 
full-time horizon of the analysis, which begins in calendar year 2022.
    While the PRIA reported that ``seven states (CO, DE, KY, ND, NM, 
NV, TX) experienced an increase in the number of Title X clinics after 
the 2019 regulatory change,'' this observation is different than the 
claim about increases in clients. Colorado, Delaware, Kentucky, North 
Dakota, New Mexico, and Texas all saw declines in the number of female 
users served in 2019 and 2020 compared to 2018 (male users saw declines 
as well). Nevada increased the number of female users from 9,236 in 
2018 to 11,156 in 2019, and again to 11,190 in 2020. The specific claim 
about Ohio cannot be supported with the available data. Ohio Title X 
grant recipients reported 83,497 female clients served in 2018, 
dropping to 68,669 in 2019, and dropping further still to 27,322 in 
2020. Similarly, given the implementation of the 2019 rule occurred 
midway through the calendar year, the 2019 data likely mask the full 
negative impact of the 2019 rule that year.
    Summary of comments addressing the PRIA that were generally 
supportive of the rulemaking:
    Several comments agreed with the observation in the PRIA that the 
2019 rule resulted in a reduction in grantees and clients served under 
the Title X program. Several comments gave examples of states or other 
entities that saw a decrease in clients served. Several comments 
discussed the disproportionate impact the 2019 rule had on low-income 
individuals, individuals in rural communities, people of color, and 
other populations. Several comments discussed the impact of the 2019 
rule on the quality of family planning services outside the Title X 
program, as well as the financial impact on clients receiving services 
outside the Title X program. Several comments argued that other sources 
of funding besides the Title X program, including state funding, would 
not be reliable sources of funding in the future.
    Responses to comments addressing the PRIA that were generally 
supportive of the rulemaking:
    The Department appreciates the specific examples provided in 
comments and agrees with the assessment that the 2019 rule resulted in 
a reduction in grantees and clients served at the national level, and 
that these effects were more pronounced in certain regions, 
communities, and demographic groups. The PRIA concluded, and this 
regulatory impact analysis affirms, that this rulemaking will likely 
result in an increase in clients served within the Title X program 
compared to a baseline of no further regulatory action. The Department 
also maintains the finding in the Further Discussion of Distributional 
Effects Section in the PRIA in this analysis that the effects of this 
final rule will accrue approximately in proportion with income and race 
and ethnicity figures typically served by the Title X program.
    The Department agrees that services provided outside the Title X 
program were not always identical to Title X-funded services. While 
some providers were able to provide reproductive health services in the 
absence of Title X funding, comments disclose that they were not 
providing the same services provided in Title X program. Specifically, 
commenters suggested that services provided outside of the Title X 
program did not follow the same standards as in Title X, and that the 
schedule of discounts and subsidies were not applied as required in the 
Title X program.
    The Department agrees with the comments that other sources of 
funding besides the Title X program may not be reliable sources of 
funding over calendar years 2022 through 2026, the time horizon of the 
PRIA and this final regulatory impact analysis. The Department has 
expanded the discussion of this point in the analysis.
Comments Received in Response to Executive Order 13132 Federalism 
Review
    Comment: Several comments were critical of the Regulatory Impact 
Analysis, stating that it ignores the federalism implications of the 
proposed rule. These comments argued that the proposed rule compels 
states to adopt policies that conflict with their own laws, 
particularly with regard to subrecipient restrictions that several 
states have put in place, and other state-described ``integrity 
requirements.'' Additionally, several comments raised concerns that the 
Department did not extend the comment period to specifically study the 
federalism impacts. Other comments expressed a belief that the proposed 
rule would have no federalism effects as it is a discretionary grant 
program in which states can choose to participate or not.
    Response: While the Department agrees that states have an interest 
in enforcement of their statutes, it believes that this final rule 
respects federalism, as it does not interfere with state laws. As noted 
previously, the Department has decided not to include a subrecipient 
nondiscrimination provision in the final rule at this time and, thus, 
concerns raised by these comments about harm to state program integrity 
requirements or a need to extend the deadline to assess the impact of 
this harm are now moot.
    Additionally, while states are eligible to apply for Title X 
grants, the Title X statute was not enacted as a federal-state 
cooperative statute, as is made clear by the eligibility of nonprofit, 
private entities to apply for grants directly. And, since the 
Department is free to attach reasonable conditions to the awarding of 
funds to carry out best its statutory goals and these conditions only 
apply to the receipt of federal Title X funds, states that object to 
the rule requirements or believe that there is a conflict with state 
law priorities are free to opt out of the federal grant program. Thus, 
the final rule does not interfere with state laws or have federalism 
implications, as state laws are only implicated if those states with 
contrary state laws wish to apply for Title X funds.

D. Summary of Changes

    The Department has revised the economic analysis of impacts to 
account for additional information, newer data, and in response to 
comments. Many of the estimates and Tables have been updated to account 
for minor revisions to the calendar year 2020 data. For example, Table 
D1 now identifies 75

[[Page 56170]]

Grantees, 867 Subrecipients, 3,031 Service Sites, and 1,536,743 Clients 
Served, compared to 73 Grantees, 803 Subrecipients, 2,682 Service 
Sites, and 1,536,744 Clients Served reported in the PRIA. These revised 
estimates carry through to other estimates and Tables.
    As described in greater detail in the Preamble, the final rule 
adopts eight of the fourteen revisions initially proposed in the NPRM 
and nine of the ten technical corrections initially proposed in the 
NPRM as final without additional changes. 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 
compared to what was proposed in the NPRM. This analysis has been 
updated to be consistent with these changes, but these changes do not 
substantially alter the estimates of the quantified economic impacts.

E. Final Economic Analysis of Impacts

a. Background
    The Title X family planning program, administered by the U.S. 
Department of Health and Human Services (HHS), Office of Population 
Affairs (OPA), is the only federal program dedicated solely to 
supporting the delivery of family planning and related preventive 
healthcare. The program is designed to provide ``a broad range of 
acceptable and effective family planning methods and services 
(including natural family planning methods, infertility services, and 
services for adolescents)'' with priority given to persons from low-
income families. In addition to offering these methods and services on 
a voluntary and confidential basis, Title X-funded service sites 
provide contraceptive education and counseling; breast and cervical 
cancer screening; STIs and HIV testing, referral, and prevention 
education; and pregnancy diagnosis and counseling. The program is 
implemented through competitively awarded grants to state and local 
public health departments and family planning, community health, and 
other private nonprofit agencies. In fiscal year 2021, the Title X 
program received approximately $286.5 million in discretionary 
funding.\14\
---------------------------------------------------------------------------

    \14\ Does not include supplemental funding.
---------------------------------------------------------------------------

    On March 4, 2019, HHS published a final rule to ``prohibit family 
planning projects from using Title X funds to encourage, promote, 
provide, refer for, or advocate for abortion as a method of family 
planning; require assurances of compliance; eliminate the requirement 
that Title X projects provide abortion counseling and referral; require 
physical and financial separation of Title X activities from those 
which are prohibited under section 1008; provide clarification on the 
appropriate use of funds in regard to the building of infrastructure, 
and require additional reporting burden from grantees.''
b. Market Failure or Social Purpose Requiring Federal Regulatory Action
    The regulatory impact analysis associated with the 2019 rule 
predicted that the additional restrictions on grantees would result in 
``an expanded number of entities interested in participating in Title 
X.'' Further, the analysis suggested the 2019 rule would result in 
``enhanced patient service and care.'' Contrary to these predictions, 
during the initial period of the 2019 rule's implementation, the policy 
appears to have had the opposite effect. As described in greater detail 
in the Baseline section, the restrictions included in the 2019 rule are 
associated with a substantial reduction in the number of Title X 
grantees, subrecipients, and service sites, resulting in a 
corresponding reduction in total clients served. The Department is 
compelled to act quickly to ameliorate these negative consequences by 
promulgating this final rule since the Title X program serves a low-
income population that is particularly vulnerable to losing access to 
these services. This final rule is needed to improve the functioning of 
government and the effectiveness of the Title X program.
c. Purpose of the Rule
    This final rule will revise the regulations that govern the Title X 
family planning services program by revoking the 2019 rule and 
readopting the 2000 regulations with several modifications. This 
approach will allow the Title X program grantees, subrecipients, and 
service sites to have a greater impact on public health than under the 
current regulatory approach.
d. Baseline Conditions and Impacts Attributable to the Rule
    The Department adopts a baseline that assumes the requirements of 
the 2019 rule remain in place over the period of our analysis. To 
characterize the real-world impact of the Title X program under this 
regulatory approach, the Department developed an annual forecast of 
grantees, subrecipients, service sites, and total clients served. The 
key inputs to the forecast are historical data on Title X service 
grantees. For calendar years 2016 to 2020, this information is 
summarized in the 2020 Title X Family Planning Annual Report.

                                       Table D1--Title X Service Grantees
----------------------------------------------------------------------------------------------------------------
              Year                     2016            2017            2018            2019            2020
----------------------------------------------------------------------------------------------------------------
Grantees........................              91              89              99             100              75
Subrecipients...................           1,117           1,091           1,128           1,060             867
Service Sites...................           3,898           3,858           3,954           3,825           3,031
Clients Served..................       4,007,552       4,004,246       3,939,749       3,095,666       1,536,743
----------------------------------------------------------------------------------------------------------------
Source: Title X Family Planning Annual Report, 2020: Exhibit A-2a.

    The data for calendar years 2016-2019 included all grantees, 
subrecipients, and service sites operating at any time during the year. 
The implementation of the 2019 rule occurred mid-year in 2019. 
Following this regulation, 19 grantees, 231 subrecipients, and 945 
service sites withdrew from the Title X program. The reduced number of 
grantees, subrecipients, services sites, and clients served observed in 
2019 and 2020 cannot be explained by a reduction in discretionary 
funding for the program, which has remained constant at $286.5 million 
throughout this time period. Since the 2019 figure includes clients 
served by these service sites for more than half of the year, adopting 
3.1 million clients served as an annual forecast would likely overstate 
activity in the program under the current regulations. Indeed, 
preliminary figures for 2020 approximate that only 1.5 million clients 
were served. However, this figure likely represents an underestimate 
for a typical year of the

[[Page 56171]]

program under the current regulations since services were likely 
disrupted by the ongoing public health emergency.
    As the primary estimate, the Department adopts 2,512,066 clients 
served as the baseline annual impact of Title X under the policies of 
the 2019 rule. This 2.5 million-figure corresponds to the number of 
clients served in 2019 among remaining grantees as of March 2021. For 
comparison, this primary estimate represents a 37 percent reduction in 
clients served compared to the average of clients served from 2016 to 
2018. In the Uncertainty and Sensitivity Analysis Section, the 
Department adopts the 1.5 million-client figure as a lower-bound 
estimate, and 3.1 million clients as an upper-bound estimate of the 
annual program impact under the baseline.
    Table D2 summarizes the baseline forecast for the same categories 
of historical data presented in Table D1. The Department adopts the 
current count for grantees, subrecipients, and services sites and 
assumes constant funding and that these figures will be constant over 
the time horizon of this analysis.

             Table D2--Baseline Forecast of Title X Services
------------------------------------------------------------------------
                      Baseline forecast                         Annual
------------------------------------------------------------------------
Grantees....................................................          75
Subrecipients...............................................         867
Service Sites...............................................       3,031
Clients Served..............................................   2,512,066
------------------------------------------------------------------------

    In addition to the reduction in grantees, subrecipients, service 
sites, and total client served, the Department notes that six states 
currently have no Title X services, including HI, ME, OR, UT, VT, and 
WA. There are six additional states that have limited Title X services, 
including AK, CT, MA, MN, NH, and NY.\15\
---------------------------------------------------------------------------

    \15\ As noted earlier, seven states (CO, DE, KY, ND, NM, NV, TX) 
experienced a meaningful increase in the number of Title X clinics 
after the 2019 regulatory change.
---------------------------------------------------------------------------

    In line with the reduction in clients served under the 2019 rule, 
data also reveal a significant drop in services provided. For example, 
when comparing 2019 figures to 2018, 225,688 fewer clients received 
oral contraceptives; 49,803 fewer clients received hormonal implants; 
and 86,008 fewer clients received intrauterine devices (IUDs). For oral 
contraceptives and IUDs, this was a 27 percent reduction, and for 
hormonal implants, a 21 percent reduction. These percentages are 
similar in magnitude to the 21 percent reduction in clients served in 
2019 compared to 2018. Additionally, 90,386 and 188,920 fewer Pap tests 
and clinical breast exams, respectively, were performed in 2019 
compared to 2018. Confidential HIV tests decreased by 276,109. Testing 
for STIs decreased by 256,523 for chlamydia, 625,802 for gonorrhea, and 
77,524 for syphilis. Appendix A of the FPAR contains national annual 
trends for many of the services discussed above. The reductions in 
services reported in 2019 compared to 2018 represent the largest year-
over-year reductions in services for each reported measure since at 
least 2014. Similar to the earlier discussion relating to long-term 
trends relating to clients, we attribute the bulk of the reductions to 
these services to the 2019 final rule.
    For the forecast of services provided under the baseline scenario, 
the Department adopts the percentage of clients receiving each service 
in the 2019 Title X Family Planning Annual Report. For example, in 
2019, about 23 percent of female clients received a clinical breast 
exam. The Department assumes the same share of clients will be served 
by Title X for screening and STI testing. Table D3 reports the best 
estimate of the annual services provided under the baseline scenario. 
These services are described in greater detail later in this Section.

  Table D3--Baseline Title X Cancer Screening and Sexually Transmitted
                            Infection Testing
------------------------------------------------------------------------
                            Year                                Annual
------------------------------------------------------------------------
Clinical Breast Exams.......................................     509,550
Pap Tests...................................................     443,087
Chlamydia Test..............................................   1,266,508
Gonorrhea Test..............................................   1,420,198
Syphilis Test...............................................     536,619
Confidential HIV Test.......................................     777,536
------------------------------------------------------------------------
Source: Calculations based on Title X Family Planning Annual Report,
  2019: Exhibits 26 and 29.

    The Department predicts that the main effect of the final rule 
would be to return to Title X program impact levels observed prior to 
the 2019 rule. The estimates of the long-run equilibrium of grantees, 
subrecipients, service sites, and total clients served are informed by 
the data from 2016 to 2018, the last three years of data that are 
unaffected by the declines experienced following the 2019 rule. 
Specifically, the Department adopts the average across these three 
years as the long-run estimates. These averages are 93 grantees, 1,112 
subrecipients, 3,903 service sites, and approximately 4.0 million 
clients served.
    To complete the forecast of the policy scenario, the Department 
assumes that it will take two years for program participation and 
clients served to achieve the long-run equilibrium estimates. This two-
year phase-in is consistent with a scenario in which most service sites 
that withdrew from the Title X program have remained open, with some 
operating at a lower capacity, than they did prior to the 2019 rule. It 
is also consistent with an expectation that many of the grantees and 
service sites that withdrew from the program would be able to rejoin if 
the NPRM issued on April 15, 2021, were finalized. In year one, 
following the effective date of the proposed rule, the number of 
clients served would increase to approximately 3.2 million. In year 
two, this number would increase again to approximately 4.0 million and 
remain constant for the duration of the analysis. These figures are 
presented in Table D4. The Department acknowledges uncertainty in this 
estimate and includes a discussion in the Uncertainty and Sensitivity 
Section, below.

                         Table D4--Policy Scenario Forecast of Title X Service Grantees
----------------------------------------------------------------------------------------------------------------
              Year                     2022            2023            2024            2025            2026
----------------------------------------------------------------------------------------------------------------
Grantees........................              84              93              93              93              93
Subrecipients...................             990           1,112           1,112           1,112           1,112
Service Sites...................           3,467           3,903           3,903           3,903           3,903
Clients Served..................       3,247,958       3,983,849       3,983,849       3,983,849       3,983,849
----------------------------------------------------------------------------------------------------------------


[[Page 56172]]

    To characterize the effect of the final rule, the Departments 
compares the policy scenario forecast to the baseline forecast 
described in the previous section. Table D5 reports the difference 
between these two scenarios, which represents the net effect of the 
proposed rule. For example, in year one after this rule is effective, 
the number of clients served would increase by approximately 736,000 as 
compared to the baseline scenario. Approximately 88 percent of clients 
served in 2016 to 2018 are female, and the Department uses this 
percentage to estimate the increase in clients served by sex under the 
policy scenario.

                            Table D5--Effect of the Proposed Rule on Title X Services
----------------------------------------------------------------------------------------------------------------
              Year                     2022            2023            2024            2025            2026
----------------------------------------------------------------------------------------------------------------
Increase in Grantees............               9              18              18              18              18
Increase in Subrecipients.......             123             245             245             245             245
Increase in Service Sites.......             436             872             872             872             872
Increase in Clients Served......         735,892       1,471,783       1,471,783       1,471,783       1,471,783
    Female......................         648,996       1,297,992       1,297,992       1,297,992       1,297,992
    Male........................          86,896         173,791         173,791         173,791         173,791
----------------------------------------------------------------------------------------------------------------

    Clients served under the Title X program experience outcomes that 
include reducing unintended pregnancy through greater access to 
contraception. The averted unintended pregnancies translate to a 
reduction in unplanned births, a reduction in abortions, and reduction 
in miscarriages. Also, Title X clients receive cancer screenings and 
testing for STIs. These screenings and testing can identify treatable 
conditions, improving the quality of life and extending the lives of 
beneficiaries. In the case of STIs, additional testing and 
corresponding earlier treatment can reduce the likelihood of worse 
health outcomes and future infertility resulting from those infections. 
This final rule will expand service to socioeconomically disadvantaged 
populations, most of whom are female, low-income, and young. The 
Department discusses this in greater detail in the Section on 
Distributional Effects.
    To further explore the likely effect of the Title X program on 
unintended pregnancy, we rely on existing methodology for estimating 
number of unintended pregnancies prevented each year among U.S. women 
who depend on publicly funded family planning services.\16\ Among this 
subgroup of women who use any method of contraception, 46 in 1,000 
women are expected to experience an unintended pregnancy. This figure 
can be compared to 296 unintended pregnancies per 1,000 women who are 
unable to access publicly funded family planning services. The 
Department applies this estimate of a reduction of 250 unintended 
pregnancies per 1,000 contraception clients to the number of additional 
female clients served under the Title X program who adopt any method of 
contraception.
---------------------------------------------------------------------------

    \16\ Jennifer J. Frost and Lawrence B. Finer (2017). Memo 
entitled ``Unintended pregnancies prevented by publicly funded 
family planning services: Summary of results and estimation 
formula.'' https://www.guttmacher.org/sites/default/files/pdfs/pubs/Guttmacher-Memo-on-Estimation-of-Unintended-Pregnancies-Prevented-June-2017.pdf. Accessed on March 14, 2021.
---------------------------------------------------------------------------

    For year one, the analysis reflects multiplying 735,892 clients by 
88 percent to yield 648,996 female clients. Among female clients, 
approximately 14 percent indicate they are not using a method of 
contraception, according to figures in the 2019 Title X Family Planning 
Annual Report. The analysis reduces the potential number of clients 
that would potentially reduce the likelihood of an unintended pregnancy 
by 14 percent to yield 558,205 clients expected to benefit from a 
contraceptive method. Approximately 47 percent of unintended 
pregnancies result in births, 34 percent in abortion, and 19 percent in 
a miscarriage.\17\
---------------------------------------------------------------------------

    \17\ Jennifer J. Frost, Lori F. Frohwirth, Nakeisha Blades, Mia 
R. Zolna, Ayana Douglas-Hall, and Jonathan Bearak (2017). ``Publicly 
Funded Contraceptive Services at U.S. Clinics, 2015. https://www.guttmacher.org/sites/default/files/report_pdf/publicly_funded_contraceptive_services_2015_3.pdf. Accessed on March 
14, 2021.

                    Table D6--Effect of the Proposed Rule on Title X-Associated Contraception
----------------------------------------------------------------------------------------------------------------
              Year                     2022            2023            2024            2025            2026
----------------------------------------------------------------------------------------------------------------
Clients Served..................         735,892       1,471,783       1,471,783       1,471,783       1,471,783
Women Served....................         648,996       1,297,992       1,297,992       1,297,992       1,297,992
Women Served Using Contraception         558,205       1,116,411       1,116,411       1,116,411       1,116,411
----------------------------------------------------------------------------------------------------------------

    Unintended pregnancies increase the risk for poor maternal and 
infant outcomes. Women who give birth following an unintended pregnancy 
are less likely to have benefitted from preconception care, to have 
optimal spacing between births, and to have been aware of their 
pregnancy early on, which in turn makes it less likely that they would 
have received prenatal care early in pregnancy.^{18 19}
---------------------------------------------------------------------------

    \18\ Jessica D. Gipson, Michael A. Koenig, and Michelle J. 
Hindin. ``The Effects of Unintended Pregnancy on Infant, Child, and 
Parental Health: A Review of the Literature.'' Studies in family 
planning 39.1 (2008): 18-38. Web.
    \19\ Power to Decide. Maternal and Infant Health and the 
Benefits of Birth Control in America. Accessed on March 8, 2020 from 
https://powertodecide.org/sites/default/files/resources/supporting-materials/getting-the-facts-straight-chapter-3-maternal-infant-health.pdf.
---------------------------------------------------------------------------

    Title X funding recipients also perform preventive health services 
such as cervical and breast cancer screening, and testing for STIs, 
including chlamydia, gonorrhea, syphilis, and HIV. Table D7 presents 
the effect of the final rule on Title X-associated cervical and breast 
cancer screenings. These figures are calculated by multiplying the 
number of additional women served by the program in each year by 
approximately 23 percent for clinical breast exams, of which five 
percent result in a referral for further evaluation; and 20 percent for 
Pap testing, of which 13 percent with a result of atypical squamous 
cells (ASC) that require further evaluation and possibly

[[Page 56173]]

treatment, and one percent of which have a high-grade squamous 
intraepithelial lesion (HSIL) \20\ or higher, indicating the presence 
of a more severe condition.
---------------------------------------------------------------------------

    \20\ HSIL is the abnormal growth of certain cells on the surface 
of the cervix.
---------------------------------------------------------------------------

    Clinical breast exams can identify patients requiring further 
evaluation of an abnormal finding. Pap tests (or pap smear tests) can 
detect precancers and cervical cancer cells and can also be tested for 
viral infections that can turn into cervical cancer. At a population 
level, these screenings save lives by helping patients identify cancer 
earlier and by preventing other conditions from developing into cancer.

    Table D7--Effect of the Final Rule on Title X-Associated Cervical and Breast Cancer Screening Activities
----------------------------------------------------------------------------------------------------------------
              Year                     2022            2023            2024            2025            2026
----------------------------------------------------------------------------------------------------------------
Clinical Breast Exams...........         149,269         298,538         298,538         298,538         298,538
Referred........................           7,463          14,927          14,927          14,927          14,927
Pap Tests.......................         129,799         259,598         259,598         259,598         259,598
    Tests with ASC or higher....          17,304          34,609          34,609          34,609          34,609
    Tests with HSIL or higher...             195             391             391             391             391
----------------------------------------------------------------------------------------------------------------

    Table D8 presents the effect of the proposed rule on Title X-
associated testing for STIs among female clients. These are calculated 
by adopting estimates that 49 percent of women are tested for 
chlamydia, 55 percent for gonorrhea, 19 percent for syphilis, and 28 
percent for HIV. Table D9 presents the same information for men. The 
share of male clients tested for these infections are the following: 61 
percent for chlamydia, 68 percent for gonorrhea, 39 percent for 
syphilis, and 53 percent for HIV.

               Table D8--Additional Women Tested for Sexually Transmitted Infections Under Title X
----------------------------------------------------------------------------------------------------------------
              Year                     2022            2023            2024            2025            2026
----------------------------------------------------------------------------------------------------------------
Chlamydia.......................         318,008         636,016         636,016         636,016         636,016
Gonorrhea.......................         356,948         713,895         713,895         713,895         713,895
Syphilis........................         123,309         246,618         246,618         246,618         246,618
Confidential HIV................         181,719         363,438         363,438         363,438         363,438
----------------------------------------------------------------------------------------------------------------


                Table D9--Additional Men Tested for Sexually Transmitted Infections Under Title X
----------------------------------------------------------------------------------------------------------------
              Year                     2022            2023            2024            2025            2026
----------------------------------------------------------------------------------------------------------------
Chlamydia.......................          53,006         106,013         106,013         106,013         106,013
Gonorrhea.......................          59,089         118,178         118,178         118,178         118,178
Syphilis........................          33,889          67,779          67,779          67,779          67,779
Confidential HIV................          46,055          92,109          92,109          92,109          92,109
----------------------------------------------------------------------------------------------------------------

    Table D10 reports the additional total clients tested for STIs 
under Title X. These tests can identify treatable conditions that can 
cause discomfort, permanent damage to reproductive systems including 
infertility, and in certain cases, death. The 2019 Title X Family 
Planning Annual Report indicates confidential HIV testing identifies a 
positive case for approximately 0.38 percent of all HIV tests 
performed. Under the final rule, testing under Title X is estimated to 
identify an additional 873 positive cases of HIV in the first year. In 
subsequent years, this estimate increases to 1,745. Testing for these 
STIs can also reduce the likelihood that an individual will spread an 
infection. In addition to testing, Title X-funded service sites also 
provide HIV/AIDS prevention education. Pre-exposure prophylaxis (PrEP) 
has emerged as an effective HIV prevention strategy for individuals who 
are most at risk, and the inclusion of PrEP in the HIV prevention 
services provided at Title X sites is becoming an increasingly 
important method for protecting individuals of all ages from acquiring 
HIV.

             Table D10--Additional Clients Tested for Sexually Transmitted Infections Under Title X
----------------------------------------------------------------------------------------------------------------
              Year                     2022            2023            2024            2025            2026
----------------------------------------------------------------------------------------------------------------
Chlamydia.......................         371,014         742,029         742,029         742,029         742,029
Gonorrhea.......................         416,037         832,074         832,074         832,074         832,074
Syphilis........................         157,199         314,397         314,397         314,397         314,397
Confidential HIV................         227,774         455,547         455,547         455,547         455,547
Positive Test Results...........             873           1,745           1,745           1,745           1,745
----------------------------------------------------------------------------------------------------------------

    Additional services of the type provided under Title X will likely 
result in reduced costs to taxpayers in line with a reduction in 
unintended pregnancies, pre-term and low birth weight births, STIs, 
infertility, and

[[Page 56174]]

cervical cancer. One report estimates that each dollar spent on these 
services results in a net government saving of $7.09.\21\ We do not 
replicate the calculations, but note that they are derived from cost 
savings associated with averting unintended pregnancy and complications 
such as pre-term and low birth weight births. These cost savings are 
also derived from detecting and treating STIs that would have resulted 
in more serious outcomes, including infertility, cancer, and death.
---------------------------------------------------------------------------

    \21\ Jennifer J. Frost, Adam Sonfield, Mia R. Zolna, and 
Lawrence B. Finer (2014). ``Return on Investment: a fuller 
assessment of the benefits and costs of the US publicly funded 
family planning program.'' Milbank Quarterly 2014 Dec; 92(4): 696-
749.
---------------------------------------------------------------------------

    In addition to the effects described above, the final rule will 
also enhance the equity and dignity associated with access to family 
planning services provided by Title X. A recent research brief 
summarized interviews with 30 women sharing their experiences with 
contraceptive access, providing suggestive evidence that birth control 
has an important positive impact on women's lives. Interviewees noted 
that birth control allowed women to ``to pursue academic and 
professional goals, achieve financial stability, and maintain their 
mental and physical health.'' \22\ These recent interviews are 
consistent with the historical experience of the importance of birth 
control. For example, one econometric study identifies a causal 
relationship between the introduction and diffusion of the birth 
control pill and the increase in women enrolling in professional degree 
programs and increasing the age at first marriage.\23\ As of a result 
of the Affordable Care Act's contraceptive coverage requirement, Title 
X can play a critical role, helping provide insured clients with access 
to contraception without cost-sharing alongside its longstanding role 
supporting contraceptive access without cost-sharing for Medicaid 
beneficiaries and those whose incomes are equal to or less than 100 
percent of the federal poverty level (FPL), which allows these clients 
to experience these and other positive outcomes associated with access 
to contraception.
---------------------------------------------------------------------------

    \22\ Rebecca Peters, Sarah Benetar, Brigette Courtot, and Sophia 
Yin (2019). ``Birth Control is Transformative.'' Urban Institute. 
https://www.urban.org/sites/default/files/publication/99912/birth_control_is_transformative_1.pdf. Accessed April 6, 2021.
    \23\ Goldin, Claudia and Lawrence F. Katz (2002). ``The power of 
the pill: Oral contraceptives and women's career and marriage 
decisions.'' Journal of Political Economy 110(4): 730-770.
---------------------------------------------------------------------------

    Researchers have identified other economic, social, and health 
impacts of increased access to family planning, contraception, and 
treatment. For example, Bailey et al. (2019) finds ``that children born 
after the introduction of federal family planning programs were seven 
percent less likely to live in poverty and 12 percent less likely to 
live in households receiving public assistance.'' They perform an 
additional bounding analysis, which suggests that about two thirds of 
the estimated gains are due to increases in the incomes of parents.\24\ 
A recent summary discusses other impacts of access to family planning 
services in the United States and in other countries, which extends 
beyond women and girls, to their children and wider communities.\25\
---------------------------------------------------------------------------

    \24\ Bailey, Martha J., Olga Malkova, Zo[euml] M. McLaren 
(2019). ``Does Access to Family Planning Increase Children's 
Opportunities? Evidence from the War on Poverty and the Early Years 
of Title X.'' Journal of Human Resources 54:4 pp. 825-856. 
doi:10.3368/jhr.54.4.1216-8401R1.
    \25\ Emily Sohn (2020). ``Strengthening society with 
contraception.'' Nature 588, S162-S164.
---------------------------------------------------------------------------

    The tables above present observable metrics of the effect of the 
Title X program, which is important for evaluating the direct effect of 
the program. For this reason, the scope of the analysis initially 
focuses on clients served and services provided by Title X-funded 
sites. To properly account for the net effect of the final rule when 
comparing the baseline scenario to the policy scenario, the Department 
would need to assess the extent to which clients and services continue 
to be provided through other channels than Title X-funded sites without 
the proposed rule. As a general matter, the impacts of this final rule 
may include:
     Transfers between grantees and prospective grantees within 
the Title X program;
     other transfers (for example, if Title X newly funds 
medical services that would, in the absence of the proposed rule, be 
provided by charitable organizations or other private payers); and
     societal benefits and costs to the extent that the volume 
or characteristics (such as location, which determines travel costs) of 
medical services would differ with and without the final rule.
    As noted earlier in this preamble, all Planned Parenthood 
affiliates--which, in 2015, served 41 percent of all contraceptive 
clients at Title X-funded service sites--withdrew from Title X, citing 
the 2019 rule. However, a comparison of Planned Parenthood's two most 
recent annual financial reports indicates no subsequent decrease in the 
number of patients served and an increase, from 9.8 million to 10.4 
million, in the number of services provided per annum (pre-
pandemic).\26\ Although such year-to-year comparisons are simplistic 
and a focus on just one organization (even a prominent one, with 
extensive activities) has obvious limitations, this evidence may 
suggest that the Title X program impacts quantified elsewhere in this 
regulatory impact analysis may largely be associated with transfers.
---------------------------------------------------------------------------

    \26\ Please see https://www.plannedparenthood.org/uploads/filer_public/2e/da/2eda3f50-82aa-4ddb-acce-c2854c4ea80b/2018-2019_annual_report.pdf and https://www.plannedparenthood.org/uploads/filer_public/67/30/67305ea1-8da2-4cee-9191-19228c1d6f70/210219-annual-report-2019-2020-web-final.pdf.
---------------------------------------------------------------------------

    The Department received a number of public comments drawing 
connections between the short-term effects of the 2019 rule and long-
term potential for a reduction in total family planning clients served, 
not limited to the Title X program. For example, two states (NY, WA) 
reported receiving emergency reserve funds through state funding in 
order to sustain the level of care that they provided under Title X; 
however, both noted that this funding is not reliable and sustainable 
from year to year. One grantee in Maine reported keeping all clinics 
open and operating with the use of the association's reserve funds and 
through private fundraising, which was an unsustainable and impractical 
task to continue. Another provider also reported fundraising to 
maintain care while also noting the administrative burden; however, 
many health centers were forced to close or reduce hours due to the 
lack of Title X funding. The same organization also reported the need 
to scale back or eliminate education and outreach programs in many 
states. These public comments suggest that the long-term effect of the 
2019 rule would have been to reduce clients served and family planning 
services provided beyond the Title X program.
    In addition to the effects on the quantity of services, several 
comments discussed the effects on the quality of services provided. One 
organization and the Attorneys General of 22 states and the District of 
Columbia noted that losing Title X providers had a negative effect on 
patients that sought care. They argued that it was more difficult for 
patients to obtain culturally competent care and that the requirements 
of the 2019 rule placed a burden on providers and their method of 
pregnancy counseling, as they were ``inconsistent with the standards of 
care and required incomplete and confusing lists and referrals for 
pregnant clients.'' Finally, several states reported that while their 
efforts were refocused to recruiting and

[[Page 56175]]

onboarding new providers into their Title X network under the 2019 
rule, they faced resistance or a lack of interest, and their provider 
networks did not increase under the 2019 rule, continuing to adversely 
impact the communities they serve.
    These public comments suggest that the effects identified in this 
regulatory impact analysis for the time horizon covering calendar year 
2022 through 2026 are unlikely to be limited to a reversal of what was 
observed immediately after issuance of the 2019 final rule. The 
Department acknowledges persistent challenges with clearly 
disaggregating the effects that represent transfers from effects that 
represent benefits and costs as a result of this final rule; however, 
it is important to reiterate that total Title X funding remained 
unchanged upon issuance of the 2019 final rule and will be unchanged as 
a result of this final rule, so while some entities receive less 
funding (and they and their clients experience regulation-induced 
ancillary harm, which can manifest itself in the quantity or quality of 
associated services), other entities receive more funding. The 
Department maintains the analytical approach of estimating the number 
of additional clients served and services provided under the Title X 
program under this final rule, while acknowledging challenges in 
quantitatively assessing whether this final rule will result in 
additional clients served and family planning services provided, not 
limited to the Title X program, as compared to the baseline of no 
further regulatory action. Despite such uncertainty, analysis based on 
evidence available at this time generally supports a conclusion that 
the projections accompanying the 2019 rule have not been borne out.
e. Further Discussion of Distributional Effects
    The Title X program is designed to provide services with priority 
given to persons from low-income families. According to the 2019 
figures, 64 percent of clients have income under 101% of the federal 
poverty level; 14 percent between 101 percent FPL and 150 percent FPL; 
seven percent between 151 percent FPL to 200 percent FPL; three percent 
between 201 percent FPL and 250 percent FPL; seven percent over 250 
percent FPL; and five percent have an unknown or unreported income 
level. Among program clients, 33 percent self-identified as Hispanic or 
Latino of all races; three percent as Asian and Not Hispanic or Latino; 
22 percent as Black or African American and Not Hispanic or Latino; 32 
percent as White and Not Hispanic or Latino; five percent as Other or 
Unknown and Not Hispanic or Latino; and four percent are Unknown or Not 
Reported. Furthermore, Title X requires Title X projects to provide 
services for adolescents without required parental consent, thereby 
making Title X a critical source of sexual and reproductive healthcare 
for young people. In 2019, two percent of program clients were younger 
than 15, and eight percent were younger than 18. Additional information 
about the number and distribution of all family planning clients by age 
and year are available in Exhibit A-3a of the 2019 Family Planning 
Annual Report. The benefits of revoking the 2019 rule would likely 
accrue proportionally with these income and race and ethnicity figures. 
The costs of revoking the 2019 rule would likely accrue proportionally 
to the income and other demographics of the general public.
    This final rule will also likely have important geographic effects. 
As described in greater detail in the Baseline section, six states 
currently have no Title X services, and six additional states have 
limited Title X services. This final rule is expected to result in 
restoration of services to individuals in these states.
f. Uncertainty and Sensitivity Analysis
    All of the major drivers of the quantified effects of this analysis 
are dependent on the forecast of the baseline number of clients served. 
The Department acknowledges the uncertainty in this baseline and has 
performed a sensitivity analysis to quantify its importance. For the 
primary baseline, the analysis uses 2.5 million annual clients of Title 
X services, which corresponds to the number of clients in calendar year 
2019 among remaining grantees. For its sensitivity analysis, the 
Department investigates the effect of the proposed rule compared to a 
baseline with 1.5 million clients, corresponding to the estimates for 
2020. For comparison, the analysis reviewed the effects using an upper 
bound of 3.1 million clients served, which is the reported figure for 
2019, but which includes 19 grantees, 231 subrecipients, and 945 
service sites that withdrew from the Title X program following the 2019 
rule.
    Table F1 presents the number of clients served under different 
assumptions of the baseline. The analysis also recalculates the number 
of clients served for the final rule scenario for each of the baseline 
assumptions. Since the number of clients served in the first year is 
the midpoint between the baseline and long-run equilibrium figure, the 
number of clients served in 2022 under the final rule is lower for the 
lower-bound scenario than the primary baseline. Similarly, the number 
of clients served under the final rule is higher in the upper-bound 
scenario.

                                          Table F1--Title X Clients Served Under Different Baseline Assumptions
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                          Proposed rule,  Proposed rule,
                          Year                               Baseline      Baseline, LB    Baseline, UB   Proposed  rule         LB              UB
--------------------------------------------------------------------------------------------------------------------------------------------------------
2022....................................................       2,512,066       1,536,743       3,095,666       3,247,958       2,760,296       3,539,758
2023....................................................       2,512,066       1,536,743       3,095,666       3,983,849       3,983,849       3,983,849
2024....................................................       2,512,066       1,536,743       3,095,666       3,983,849       3,983,849       3,983,849
2025....................................................       2,512,066       1,536,743       3,095,666       3,983,849       3,983,849       3,983,849
2026....................................................       2,512,066       1,536,743       3,095,666       3,983,849       3,983,849       3,983,849
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Table F2 calculates the effect of the final rule under different 
baseline assumptions. These estimates are reported by year, as well as 
in present value and annualized for the five-year time horizon of the 
analysis, applying a three percent and a seven percent discount rate. 
Under the lower-bound baseline scenario, the final rule will have about 
a 66 percent greater impact on the number of clients served in 
annualized terms under the primary baseline scenario. Under the upper-
bound baseline scenario, the final rule will have approximately a 64 
percent lesser impact.

[[Page 56176]]



          Table F2--Effect of the Proposed Rule on Title X Clients Under Different Baseline Assumptions
----------------------------------------------------------------------------------------------------------------
                                                                                  Proposed rule,  Proposed rule,
                              Year                                 Proposed rule         LB              UB
----------------------------------------------------------------------------------------------------------------
2022............................................................         735,892       1,223,553         444,092
2023............................................................       1,471,783       2,447,106         888,183
2024............................................................       1,471,783       2,447,106         888,183
2025............................................................       1,471,783       2,447,106         888,183
2026............................................................       1,471,783       2,447,106         888,183
PDV, 3%.........................................................       6,025,877      10,019,113       3,636,461
PDV, 7%.........................................................       5,346,852       8,890,110       3,226,687
Annualized, 3%..................................................       1,315,778       2,187,719         794,038
Annualized, 7%..................................................       1,304,047       2,168,215         786,959
----------------------------------------------------------------------------------------------------------------

    As discussed earlier, the Department acknowledges uncertainty in 
how quickly the Title X program will be able to restore service to 
levels experienced prior to the declines associated with the 2019 rule. 
The primary analysis adopts a two-year phase for grantees, 
subrecipients, service sites, and clients served to reach the long-run 
equilibrium estimates. If a large number of service sites have shut 
down permanently, the assumption of a two-year phase-in would likely 
result in an overestimate of the final rule's effect over the time 
horizon of the analysis. Similarly, if a small number of service sites 
have shut down, the analysis would tend to underestimate the effect of 
the final rule. Therefore, as a second sensitivity analysis, the 
Department presents estimates that adopt alternative assumptions about 
the length of time it will take to reach the long-run equilibrium 
estimates. Table F3 presents the primary estimates of clients served, 
based on a two-year phase-in, estimates without a phase-in, and 
estimates with a three-year phase-in assumption.

                          Table F3--Title X Clients With Different Phase-In Assumptions
----------------------------------------------------------------------------------------------------------------
                                                                  Proposed rule,                  Proposed rule,
                      Year                           Baseline      2-year  phase- Proposed rule,   3-year phase-
                                                                        in          no phase-in         in
----------------------------------------------------------------------------------------------------------------
2022............................................       2,512,066       3,247,958       3,983,849       3,002,660
2023............................................       2,512,066       3,983,849       3,983,849       3,493,255
2024............................................       2,512,066       3,983,849       3,983,849       3,983,849
2025............................................       2,512,066       3,983,849       3,983,849       3,983,849
2026............................................       2,512,066       3,983,849       3,983,849       3,983,849
----------------------------------------------------------------------------------------------------------------

    Table F4 calculates the effect of the final rule with different 
phase-in assumptions. These estimates are reported by year, as well as 
in present value and annualized for the five-year time horizon of the 
analysis, applying a three percent and a seven percent discount rate. 
Compared to the primary estimates, the assumption of no phase-in yields 
annualized effects of the final rule that are approximately 12 percent 
higher. Assuming a three-year phase-in yields annualized effects that 
are about 12 percent lower than the primary estimates.

          Table F4--Effect of the Proposed Rule on Title X Clients With Different Phase-In Assumptions
----------------------------------------------------------------------------------------------------------------
                                                                  Proposed rule,                  Proposed rule,
                              Year                                2-year  phase-  Proposed rule,   3-year phase-
                                                                        in          no phase-in         in
----------------------------------------------------------------------------------------------------------------
2022............................................................         735,892       1,471,783         490,594
2023............................................................       1,471,783       1,471,783         981,189
2024............................................................       1,471,783       1,471,783       1,471,783
2025............................................................       1,471,783       1,471,783       1,471,783
2026............................................................       1,471,783       1,471,783       1,471,783
PDV, 3%.........................................................       6,025,877       6,740,335       5,325,293
PDV, 7%.........................................................       5,346,852       6,034,601       4,689,098
Annualized, 3%..................................................       1,315,778       1,471,783       1,162,802
Annualized, 7%..................................................       1,304,047       1,471,783       1,143,627
----------------------------------------------------------------------------------------------------------------

g. Analysis of Regulatory Alternatives to the Proposed Rule
    The Department analyzed two alternatives to the approach under the 
final rule. The Department considered one option to maintain many 
elements of the 2019 rule and to impose additional restrictions on 
grantees. This approach would exacerbate the trends of reduced Title X 
grantees, subrecipients, service sites, and clients served that we have 
observed under the 2019 rule. Second, the Department considered 
revising the 2019 rule by readopting many elements of the 2000 
regulations, but adopting additional flexibilities for grantees and 
reducing programmatic oversight. However, experience suggests the 
compliance regime as it existed prior to the 2019 rule was effective.

IV. Environmental Impact

    The Department has determined under 21 CFR 25.30(k) that this 
action

[[Page 56177]]

is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

V. Paperwork Reduction Act

    This final rule contains information collection requirements (ICRs) 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995. No public comments were 
provided on the proposed information collections for Sec.  59.4, 59.5, 
and 59.7 proposed in the NPRM. OMB filed comment on this NPRM and 
assigned OMB Control Number 0970-0211. As previously stated in the 
preamble, the final rule is revoking the 2019 final rule in its 
entirety. As a result, the final rule does not include information data 
collection required under Sec.  59.5(a)(12) to provide documentation or 
assurance to HHS of a plan to comply with state notifications laws, and 
it does not include the requirement under Sec.  59.5(a)(13) to report 
information to HHS on subrecipients. However, additional information 
collection was identified related to Sec.  59.4, 59.5, and 59.7. The 
final rule is revising the information collections to reflect the 
additional estimated burden for the Title X grant requirements under 
Sec.  59.4, 59.5, and 59.7. A description of these provisions is given 
in the following paragraphs with an estimate of the annual burden, 
summarized in Table 1.
    Sec.  59.4 requires Title X grant applicants to describe how the 
proposed project would satisfy the regulatory requirements for the 
Title X program in their applications, including the specific project 
requirements under Sec.  59.5 and the grant review criteria specified 
under Sec.  59.7. We estimate that the time necessary for each Title X 
applicant to include this information in their grant applications would 
be 70 hours. All other reporting burden associated with grant 
applications is already approved via existing Grants.gov common forms.
    Burden of Response: The Department is committed to leveraging 
existing grant, contract, annual reporting, and other Departmental 
forms where possible, rather than creating additional, separate forms 
for recipients to sign. The burden for describing the Title X grant 
requirements is the cost for each applicant to include this information 
in their grant applications. The labor cost would consist of a medical 
and health service manager spending an average of 70 hours writing and 
incorporating the Title X program information in their grant 
applications. The Department estimates the number of applicants at 136, 
based on the number of eligible applicants who applied to the Title X 
national grant competition before the 2019 final rule was in effect. 
The mean hourly wage (not including benefits and overhead) is $55.37 
per hour for the medical and health service manager.\27\ The labor cost 
per application is $3,875.90. ($55.37 x 70 hours), and the total labor 
cost is $527,122.40 ($3,875.90 x 136 applications).
---------------------------------------------------------------------------

    \27\ 2019 labor costs for medical and health service managers, 
https://www.bls.gov/oes/2019/may/oes119111.htm.

        Table 1--Estimated Burden for Describing the Title X Grant Requirements in the Grant Application Following Publication of the Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                            Burden per                     Labor cost of
                    Regulation burden                       OMB control      Applicant      Hourly rate      response      Total annual     application
                                                                No.          responses          ($)           (hours)     burden (hours)        ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Title X Grant Requirements..............................       0970-0211             136           55.37              70           9,520      527,122.40
                                                         -----------------------------------------------------------------------------------------------
    Total cost..........................................  ..............  ..............  ..............  ..............  ..............      527,122.40
--------------------------------------------------------------------------------------------------------------------------------------------------------

List of Subjects in 42 CFR Part 59

    Family planning, Grant programs-health, Health professions, 
Abortion, Birth control, Title X.

Xavier Becerra,
Secretary, Department of Health and Human Services.

42 CFR Part 59

PART 59--GRANTS FOR FAMILY PLANNING

    For the reasons set out in the preamble, subpart A of part 59 of 
title 42, Code of Federal Regulations, is revised to read as follows:
Subpart A--Project Grants for Family Planning Services
Sec.
59.1 To what programs do these regulations apply?
59.2 Definitions.
59.3 Who is eligible to apply for a family planning services grant?
59.4 How does one apply for a family planning services grant?
59.5 What requirements must be met by a family planning project?
59.6 What procedures apply to assure the suitability of 
informational and educational material (print and electronic)?
59.7 What criteria will the Department of Health and Human Services 
use to decide which family planning services projects to fund and in 
what amount?
59.8 How is a grant awarded?
59.9 For what purposes may grant funds be used?
59.10 Confidentiality.
59.11 Additional conditions.

    Authority:  42 U.S.C. 300a-4.

Subpart A--Project Grants for Family Planning Services


Sec.  59.1   To what programs do these regulations apply?

    The regulations of this subpart are applicable to the award of 
grants under section 1001 of the Public Health Service Act (42 U.S.C. 
300) to assist in the establishment and operation of voluntary family 
planning projects. These projects shall consist of the educational, 
comprehensive medical, and social services necessary to aid individuals 
to determine freely the number and spacing of their children.


Sec.  59.2   Definitions.

    As used in this subpart:
    Act means the Public Health Service Act, as amended.
    Adolescent-friendly health services are services that are 
accessible, acceptable, equitable, appropriate and effective for 
adolescents.
    Clinical services provider includes physicians, physician 
assistants, nurse practitioners, certified nurse midwives, and 
registered nurses with an expanded scope of practice who are trained 
and permitted by state-specific regulations to perform all aspects of 
the user (male and female) physical assessments recommended for 
contraceptive, related

[[Page 56178]]

preventive health, and basic infertility care.
    Client-centered care is respectful of, and responsive to, 
individual client preferences, needs, and values; client values guide 
all clinical decisions.
    Culturally and linguistically appropriate services are respectful 
of and responsive to the health beliefs, practices and needs of diverse 
patients.
    Family means a social unit composed of one person, or two or more 
persons living together, as a household.
    Family planning services include a broad range of medically 
approved services, which includes Food and Drug Administration (FDA)-
approved contraceptive products 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.
    Health equity is when all persons have the opportunity to attain 
their full health potential and no one is disadvantaged from achieving 
this potential because of social position or other socially determined 
circumstances.
    Inclusive is when all people are fully included and can actively 
participate in and benefit from family planning, including, but not 
limited to, individuals who belong to underserved communities, such as 
Black, Latino, and Indigenous and Native American persons, Asian 
Americans and Pacific Islanders and other persons of color; members of 
religious minorities; lesbian, gay, bisexual, transgender, and queer 
(LGBTQ+) persons; persons with disabilities; persons who live in rural 
areas; and persons otherwise adversely affected by persistent poverty 
or inequality.
    Low-income family means a family whose total annual income does not 
exceed 100 percent of the most recent Poverty Guidelines issued 
pursuant to 42 U.S.C. 9902(2). ``Low-income family'' also includes 
members of families whose annual family income exceeds this amount, but 
who, as determined by the project director, are unable, for good 
reasons, to pay for family planning services. For example, 
unemancipated minors who wish to receive services on a confidential 
basis must be considered on the basis of their own resources.
    Nonprofit, as applied to any private agency, institution, or 
organization, means that no part of the entity's net earnings benefit, 
or may lawfully benefit, any private shareholder or individual.
    Quality healthcare is safe, effective, client-centered, timely, 
efficient, and equitable.
    Secretary means the Secretary of Health and Human Services (HHS) 
and any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    Service site is a clinic or other location where Title X services 
are provided to clients. Title X recipients and/or their subrecipients 
may have service sites.
    State includes, in addition to the several States, the District of 
Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana 
Islands, the U.S. Virgin Islands, American Samoa, the U.S. Outlaying 
Islands (Midway, Wake, et al.), the Marshall Islands, the Federated 
State of Micronesia, and the Republic of Palau.
    Trauma-informed means a program, organization, or system that is 
trauma-informed realizes the widespread impact of trauma and 
understands potential paths for recovery; recognizes the signs and 
symptoms of trauma in clients, families, staff, and others involved 
with the system; and responds by fully integrating knowledge about 
trauma into policies, procedures, and practices, and seeks to actively 
resist re-traumatization.


Sec.  59.3   Who is eligible to apply for a family planning services 
grant?

    Any public or nonprofit private entity in a State may apply for a 
grant under this subpart.


Sec.  59.4   How does one apply for a family planning services grant?

    (a) Application for a grant under this subpart shall be made on an 
authorized form.
    (b) An individual authorized to act for the applicant and to assume 
on behalf of the applicant the obligations imposed by the terms and 
conditions of the grant, including the regulations of this subpart, 
must sign the application.
    (c) The application shall contain
    (1) A description, satisfactory to the Secretary, of the project 
and how it will meet the requirements of this subpart;
    (2) A budget and justification of the amount of grant funds 
requested;
    (3) A description of the standards and qualifications which will be 
required for all personnel and for all facilities to be used by the 
project; and
    (4) Such other pertinent information as the Secretary may require.


Sec.  59.5   What requirements must be met by a family planning 
project?

    (a) Each project supported under this part must:
    (1) 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 prescription to the client for 
their method of choice or referrals to another provider, as requested.
    (2) Provide services without subjecting individuals to any coercion 
to accept services or to employ or not to employ any particular methods 
of family planning. Acceptance of services must be solely on a 
voluntary basis and may not be made a prerequisite to eligibility for, 
or receipt of, any other services, assistance from or participation in 
any other program of the applicant.\1\
---------------------------------------------------------------------------

    \1\ 42 U.S.C. 300a-8 provides that any officer or employee of 
the United States, officer or employee of any State, political 
subdivision of a State, or any other entity, which administers or 
supervises the administration of any program receiving Federal 
financial assistance, or person who receives, under any program 
receiving Federal assistance, compensation for services, who coerces 
or endeavors to coerce any person to undergo an abortion or 
sterilization procedure by threatening such person with the loss of, 
or disqualification for the receipt of, any benefit or service under 
a program receiving Federal financial assistance shall be fined not 
more than $1,000 or imprisoned for not more than one year, or both.
---------------------------------------------------------------------------

    (3) Provide services in a manner that is client-centered, 
culturally and linguistically appropriate, inclusive, and trauma-
informed; protects the dignity of the individual; and ensures equitable 
and quality service delivery consistent with nationally recognized 
standards of care.
    (4) Provide services in a manner that does 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.
    (5) Not provide abortion as a method of family planning.\2\ A 
project must:
---------------------------------------------------------------------------

    \2\ Providers may separately be covered by federal statutes 
protecting conscience and/or civil rights.
---------------------------------------------------------------------------

    (i) Offer pregnant clients the opportunity to be provided 
information

[[Page 56179]]

and counseling regarding each of the following options:
    (A) Prenatal care and delivery;
    (B) Infant care, foster care, or adoption; and
    (C) Pregnancy termination.
    (ii) If requested to provide such information and counseling, 
provide neutral, factual information and nondirective counseling on 
each of the options, and, referral upon request, except with respect to 
any option(s) about which the pregnant client indicates they do not 
wish to receive such information and counseling.
    (6) Provide that priority in the provision of services will be 
given to clients from low-income families.
    (7) Provide that no charge will be made for services provided to 
any clients from a low-income family except to the extent that payment 
will be made by a third party (including a government agency) which is 
authorized to or is under legal obligation to pay this charge.
    (8) Provide that charges will be made for services to clients other 
than those from low-income families in accordance with a schedule of 
discounts based on ability to pay, except that charges to persons from 
families whose annual income exceeds 250 percent of the levels set 
forth in the most recent Poverty Guidelines issued pursuant to 42 
U.S.C. 9902(2) will be made in accordance with a schedule of fees 
designed to recover the reasonable cost of providing services.
    (i) Family income should be assessed before determining whether 
copayments or additional fees are charged.
    (ii) With regard to insured clients, clients whose family income is 
at or below 250 percent of the FPL should not pay more (in copayments 
or additional fees) than what they would otherwise pay when the 
schedule of discounts is applied.
    (9) Take reasonable measures to verify client income, without 
burdening clients from low-income families. Recipients that have lawful 
access to other valid means of income verification because of the 
client's participation in another program may use those data rather 
than re-verify income or rely solely on clients' self-report. If a 
client's income cannot be verified after reasonable attempts to do so, 
charges are to be based on the client's self-reported income.
    (10) If a third party (including a Government agency) is authorized 
or legally obligated to pay for services, all reasonable efforts must 
be made to obtain the third-party payment without application of any 
discounts. Where the cost of services is to be reimbursed under title 
XIX, XX, or XXI of the Social Security Act, a written agreement with 
the title XIX, XX, or XXI agency is required.
    (11)(i) Provide that if an application relates to consolidation of 
service areas or health resources or would otherwise affect the 
operations of local or regional entities, the applicant must document 
that these entities have been given, to the maximum feasible extent, an 
opportunity to participate in the development of the application. Local 
and regional entities include existing or potential subrecipients which 
have previously provided or propose to provide family planning services 
to the area proposed to be served by the applicant.
    (ii) Provide an opportunity for maximum participation by existing 
or potential subrecipients in the ongoing policy decision making of the 
project.
    (b) In addition to the requirements of paragraph (a) of this 
section, each project must meet each of the following requirements 
unless the Secretary determines that the project has established good 
cause for its omission. Each project must:
    (1) Provide for medical services related to family planning 
(including consultation by a clinical services provider, examination, 
prescription and continuing supervision, laboratory examination, 
contraceptive supplies), in person or via telehealth, and necessary 
referral to other medical facilities when medically indicated, and 
provide for the effective usage of contraceptive devices and practices.
    (2) Provide for social services related to family planning, 
including counseling, referral to and from other social and medical 
service agencies, and any ancillary services which may be necessary to 
facilitate clinic attendance.
    (3) Provide for opportunities for community education, 
participation, and engagement to:
    (i) Achieve community understanding of the objectives of the 
program;
    (ii) Inform the community of the availability of services; and
    (iii) Promote continued participation in the project by diverse 
persons to whom family planning services may be beneficial to ensure 
access to equitable, affordable, client-centered, quality family 
planning services.
    (4) Provide for orientation and in-service training for all project 
personnel.
    (5) Provide services without the imposition of any durational 
residency requirement or requirement that the patient be referred by a 
physician.
    (6) Provide that family planning medical services will be performed 
under the direction of a clinical services provider, with services 
offered within their scope of practice and allowable under state law, 
and with special training or experience in family planning.
    (7) Provide that all services purchased for project participants 
will be authorized by the project director or their designee on the 
project staff.
    (8) Provide for coordination and use of referrals and linkages with 
primary healthcare providers, other providers of healthcare services, 
local health and welfare departments, hospitals, voluntary agencies, 
and health services projects supported by other federal programs, who 
are in close physical proximity to the Title X site, when feasible, in 
order to promote access to services and provide a seamless continuum of 
care.
    (9) Provide that if family planning services are provided by 
contract or other similar arrangements with actual providers of 
services, services will be provided in accordance with a plan which 
establishes rates and method of payment for medical care. These 
payments must be made under agreements with a schedule of rates and 
payment procedures maintained by the recipient. The recipient must be 
prepared to substantiate that these rates are reasonable and necessary.
    (10) Provide, to the maximum feasible extent, an opportunity for 
participation in the development, implementation, and evaluation of the 
project by persons broadly representative of all significant elements 
of the population to be served, and by others in the community 
knowledgeable about the community's needs for family planning services.


Sec.  59.6  What procedures apply to assure the suitability of 
informational and educational material (print and electronic)?

    (a) A grant under this section may be made only upon assurance 
satisfactory to the Secretary that the project shall provide for the 
review and approval of informational and educational materials (print 
and electronic) developed or made available under the project by an 
Advisory Committee prior to their distribution, to assure that the 
materials are suitable for the population or community to which they 
are to be made available and the purposes of Title X of the Act. The 
project shall not disseminate any such materials which are not approved 
by the Advisory Committee.
    (b) The Advisory Committee referred to in paragraph (a) of this 
section shall be established as follows:
    (1) Size. The committee shall consist of no fewer than five members 
and up to as many members the recipient

[[Page 56180]]

determines, except that this provision may be waived by the Secretary 
for good cause shown.
    (2) Composition. The committee shall include individuals broadly 
representative of the population or community for which the materials 
are intended (in terms of demographic factors such as race, ethnicity, 
color, national origin, disability, sex, sexual orientation, gender 
identity, sex characteristics, age, marital status, income, geography, 
and including but not limited to individuals who belong to underserved 
communities, such as Black, Latino, and Indigenous and Native American 
persons, Asian Americans and Pacific Islanders and other persons of 
color; members of religious minorities; lesbian, gay, bisexual, 
transgender, and queer (LGBTQ+) persons; persons with disabilities; 
persons who live in rural areas; and persons otherwise adversely 
affected by persistent poverty or inequality).
    (3) Function. In reviewing materials, the Advisory Committee shall:
    (i) Consider the educational, cultural, and diverse backgrounds of 
individuals to whom the materials are addressed;
    (ii) Consider the standards of the population or community to be 
served with respect to such materials;
    (iii) Review the content of the material to assure that the 
information is factually correct, medically accurate, culturally and 
linguistically appropriate, inclusive, and trauma informed;
    (iv) Determine whether the material is suitable for the population 
or community to which is to be made available; and
    (v) Establish a written record of its determinations.


Sec.  59.7   What criteria will the Department of Health and Human 
Services use to decide which family planning services projects to fund 
and in what amount?

    (a) Within the limits of funds available for these purposes, the 
Secretary may award grants for the establishment and operation of those 
projects which will in the Department's judgment best promote the 
purposes of section 1001 of the Act, taking into account:
    (1) The number of clients, and, in particular, the number of low-
income clients to be served;
    (2) The extent to which family planning services are needed 
locally;
    (3) The ability of the applicant to advance health equity;
    (4) The relative need of the applicant;
    (5) The capacity of the applicant to make rapid and effective use 
of the federal assistance;
    (6) The adequacy of the applicant's facilities and staff;
    (7) The relative availability of non-federal resources within the 
community to be served and the degree to which those resources are 
committed to the project; and
    (8) The degree to which the project plan adequately provides for 
the requirements set forth in these regulations.
    (b) The Secretary shall determine the amount of any award on the 
basis of an estimate of the sum necessary for the performance of the 
project. No grant may be made for less than 90 percent of the project's 
costs, as so estimated, unless the grant is to be made for a project 
which was supported, under section 1001, for less than 90 percent of 
its costs in fiscal year 1975. In that case, the grant shall not be for 
less than the percentage of costs covered by the grant in fiscal year 
1975.
    (c) No grant may be made for an amount equal to 100 percent for the 
project's estimated costs.


Sec.  59.8   How is a grant awarded?

    (a) The notice of grant award specifies how long HHS intends to 
support the project without requiring the project to recompete for 
funds. This anticipated period will usually be for three to five years.
    (b) Generally, the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
recipient must submit a separate application to have the support 
continued for each subsequent year. Decisions regarding continuation 
awards and the funding level of such awards will be made after 
consideration of such factors as the recipient's progress and 
management practices and the availability of funds. In all cases, 
continuation awards require a determination by HHS that continued 
funding is in the best interest of the government.
    (c) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.


 Sec.  59.9   For what purpose may grant funds be used?

    Any funds granted under this subpart shall be expended solely for 
the purpose for which the funds were granted in accordance with the 
approved application and budget, the regulations of this subpart, the 
terms and conditions of the award, and the applicable cost principles 
prescribed in 45 CFR part 75.


Sec.  59.10   Confidentiality.

    (a) All information as to personal facts and circumstances obtained 
by the project staff about individuals receiving services must be held 
confidential and must not be disclosed without the individual's 
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.\3\ 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.
---------------------------------------------------------------------------

    \3\ 42 U.S.C. 300(a).
---------------------------------------------------------------------------


Sec.  59.11   Additional conditions.

    The Secretary may, with respect to any grant, impose additional 
conditions prior to, at the time of, or during any award, when in the 
Department's judgment these conditions are necessary to assure or 
protect advancement of the approved program, the interests of public 
health, or the proper use of grant funds.

[FR Doc. 2021-21542 Filed 10-4-21; 4:15 pm]
BILLING CODE 4150-30-P

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