Compliance With Statutory Program Integrity Requirements

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Federal Register › Vol. 83 › 83 FR 25502

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DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 59 [Docket No.: HHS-OS-2018-0008] RIN 0937-ZA00 Compliance With Statutory Program Integrity Requirements AGENCY:

Office of the Assistant Secretary for Health, Office of the Secretary, HHS.

ACTION:

Proposed rule.

SUMMARY:

The Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, proposes to revise its Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where abortion is a method of family planning and related statutory requirements. In addition, OPA proposes amendments to the Title X regulations that would, among other things, clarify grantee responsibilities to provide a broad range of family planning methods; to require documented compliance with State and local laws requiring notification or the reporting of child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence, and human trafficking; to provide free or low cost access to family planning services for those women who are unable to obtain employer-sponsored insurance coverage for certain contraceptive services due to their employers' religious beliefs or moral convictions; to provide for the appropriate expenditure of federal Title X funds on family planning services, rather than on lobbying or related activities; and to appropriately encourage family participation in family planning decisions, all as required by Federal law.

DATES:

Comments on this proposed rule are invited. To be considered, comments must be received by July 31, 2018.

ADDRESSES:

Written comments may be submitted to the Department of Health and Human Services, Office of the Assistant Secretary for Health, Office of Population Affairs, as specified below. Any comment that is submitted will also be made available to the public

y Federal law.

DATES:

Comments on this proposed rule are invited. To be considered, comments must be received by July 31, 2018.

ADDRESSES:

Warning: Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments may be posted on the internet and can be retrieved by most internet search engines. No deletions, modifications, or redactions will be made to the comments received. Comments may be submitted anonymously.

Comments, identified by “Family Planning” may be submitted by one of the following methods:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Mail or Hand Delivery: Office of the Assistant Secretary for Health, Office of Population Affairs, Attention: Family Planning, U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Room 716G, 200 Independence Avenue SW, Washington, DC 20201.

Comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

FOR FURTHER INFORMATION CONTACT:

Valerie Huber at (202) 690-7694.

SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory Requirements of Title X of the Public Health Service Act and the Title X Appropriations Acts

Title X of the Public Health Service Act (PHS Act or the Act), 42 U.S.C. 300 through 300a-6, was enacted in 1970 by Public Law 91-572

ng any personal information provided.

FOR FURTHER INFORMATION CONTACT:

Valerie Huber at (202) 690-7694.

SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory Requirements of Title X of the Public Health Service Act and the Title X Appropriations Acts

Title X of the Public Health Service Act (PHS Act or the Act), 42 U.S.C. 300 through 300a-6, was enacted in 1970 by Public Law 91-572. It authorizes the Secretary of Health and Human Services, among other things, “to make grants to and enter into contracts with public or nonprofit private entities to assist in the establishment and operation of voluntary family planning projects which shall offer a broad range of acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services for adolescents).” PHS Act sec. 1001(a); 42 U.S.C. 300(a).

Presently, the Title X program funds approximately 90 public health departments and community health, family planning, and other private nonprofit agencies through grants, supporting delivery of family planning services at almost 4,000 service sites. 1 As a program designed to provide voluntary family planning services, the Title X program should help men, women, and adolescents make healthy and fully informed decisions about starting a family and determine the number and spacing of children.

1 Fowler, C. I., Gable, J., Wang, J., & Lasater, B. Family Planning Annual Report: 2016 National Summary (Aug. 2017), https://www.hhs.gov/opa/sites/default/files/title-x-fpar-2016-national.pdf.

Section 1008 of the Act contains the following prohibition, which has not been altered since it was enacted in 1970:

None of the funds appropriated under this title shall be used in programs where abortion is a method of family planning

J., & Lasater, B. Family Planning Annual Report: 2016 National Summary (Aug. 2017), https://www.hhs.gov/opa/sites/default/files/title-x-fpar-2016-national.pdf.

Section 1008 of the Act contains the following prohibition, which has not been altered since it was enacted in 1970:

None of the funds appropriated under this title shall be used in programs where abortion is a method of family planning.

The Conference Report described the intent of this provision as follows: It is, and has been, the intent of both Houses that funds authorized under this legislation be used only to support preventive family planning services, population research, infertility services and other related medical, information, and educational activities. The conferees have adopted the language contained in section 1008, which prohibits the use of such funds for abortion, in order to make clear this intent.

H.R. Rep. No 91-1667, at 8-9 (1970) (Conf. Rep.). Later Congresses have, through annual appropriations provisos, reiterated this requirement: “[A]mounts provided to said [voluntary family planning] projects, under such title shall not be expended for abortions.” See, e.g., Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, 132 Stat. 348, 716 (2018); Consolidated Appropriations Act, 2017, Public Law 115-31, Div. H, Title II, 131 Stat. 135, 521 (2017); Consolidated Appropriations Act, 2016, Public Law 114-113, Div. H, Title II, 129 Stat. 2242, 2602 (2015). Since it originally created the Title X program in 1970, Congress has, from time to time, imposed additional requirements on it

ublic Law 115-141, Div. H, Title II, 132 Stat. 348, 716 (2018); Consolidated Appropriations Act, 2017, Public Law 115-31, Div. H, Title II, 131 Stat. 135, 521 (2017); Consolidated Appropriations Act, 2016, Public Law 114-113, Div. H, Title II, 129 Stat. 2242, 2602 (2015). Since it originally created the Title X program in 1970, Congress has, from time to time, imposed additional requirements on it. For example, the annual Title X appropriation includes the provisos that “all pregnancy counseling shall be nondirective” 2 and that Title X funds “shall not be expended for any activity (including the publication or distribution of literature) that in any way tends to promote public support or opposition to any legislative proposal or candidate for public office.” 3 See, e.g., Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, 132 Stat. 348, 716-717 (2018); Consolidated Appropriations Act, 2017, Public Law 115-31, Div. H, Title II, 131 Stat. 135, 521 (2017).

2 See Omnibus Consolidated Rescissions and Appropriations Act, 1996, Public Law 104-134, Title II, 110 Stat.1321, 1321-221 (1996).

3 See Omnibus Consolidated Rescissions and Appropriations Act, 1996, Public Law 104-134, Title II, 110 Stat.1321, 1321-221 (1996).

Congress has given particular instructions for the services provided under Title X to minors and other vulnerable populations. Congress specifically required that Title X provide distinct services for adolescents. See PHS Act sec. 1001(a), 42 U.S.C. 300(a) (requirement to provide 4 Congress has included a rider in HHS's annual appropriations act that provides that “[n]one of the funds appropriated in this Act may be made available to any entity under title X of the PHS Act unless the applicant for the award certifies to the Secretary that it encourages family participation in the decision of minors to seek family planning services.” Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 207, 132 Stat. 348, 736 (2018)

act that provides that “[n]one of the funds appropriated in this Act may be made available to any entity under title X of the PHS Act unless the applicant for the award certifies to the Secretary that it encourages family participation in the decision of minors to seek family planning services.” Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 207, 132 Stat. 348, 736 (2018). The same appropriations rider also requires that such an applicant certify to the Secretary that it “provides counseling to minors on how to resist attempts to coerce minors into engaging in sexual activities.” Id. By means of another rider, Congress requires 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.” Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 208, 132 Stat. 348, 736 (2018).

4 See Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1998, Public Law 105-78, sec. 212, 111 Stat. 1467, 1495 (1997).

B. Title X Regulations

Since 1971, the Department has repeatedly exercised rulemaking authority with respect to the Title X program. Section 1006(a) of the Act, 42 U.S.C. 300a-4, grants rulemaking power to the Department: It provides that “[g]rants and contracts made under this subchapter shall be made in accordance with such regulations as the Secretary may promulgate.” The Department began to exercise that authority by issuing regulations implementing section 1008 in 1971. See 36 FR 18465 (Sept. 15, 1971). Although those regulations, and revised regulations issued in 1980 (45 FR 37436 (June 3, 1980)), as well as guidelines promulgated in 1981, prohibited Title X projects from providing abortion as a method of family planning, they did not provide further guidance on the application of that prohibition

thority by issuing regulations implementing section 1008 in 1971. See 36 FR 18465 (Sept. 15, 1971). Although those regulations, and revised regulations issued in 1980 (45 FR 37436 (June 3, 1980)), as well as guidelines promulgated in 1981, prohibited Title X projects from providing abortion as a method of family planning, they did not provide further guidance on the application of that prohibition. In 1982, the Department's Office of Inspector General (OIG) audited 32 Title X clinics and found that the Department's failure to provide such guidance had created confusion about precisely what activities were proscribed by the section and resulted in variations in practice among grantees. 5 The General Accounting Office (GAO, now the Government Accountability Office) recommended that “the Secretary establish clear operational guidance by incorporating into the Title X program regulations and guidelines, HHS' position on the scope of the abortion restriction in section 1008.” 6

5 HHS OIG, Review of PHS Title X Family Planning Grantees, Audit Control No. 12-33177 (Nov. 18, 1982).

6 GAO, No. HRD-82-106, Restrictions on Abortion and Lobbying Activities in Family Planning Programs Need Clarification, at 22 (Sept. 24, 1982), https://www.gao.gov/assets/140/138760.pdf.

1. 1988 Regulations and Rust v. Sullivan

rification, at 22 (Sept. 24, 1982), https://www.gao.gov/assets/140/138760.pdf.

1. 1988 Regulations and Rust v. Sullivan

On February 2, 1988, the Secretary of Health and Human Services promulgated Title X regulations (the “1988 Regulations”) to give specific program guidance regarding the statutory prohibition on the use of Title X funds in programs where abortion is a method of family planning. The Department noted “as a matter of experience with Title X, its responsibility to administer the program as provided by Congress, and its general administrative discretion, that the provisions of the current guidelines do not faithfully or effectively maintain the prohibition contained in section 1008.” Statutory Prohibition on Use of Appropriated Funds in Programs Where Abortion is a Method of Family Planning; Standard of Compliance for Family Planning Services Projects, Final Rule, 53 FR 2922, 2923 (Feb. 2, 1988). The Department sought to address this deficiency.

The 1988 Regulations had several key features to support compliance with the statutory prohibition. To more effectively implement section 1008, the regulations prohibited Title X projects from counseling or referring project clients for abortion as a method of family planning; required grantees to separate their Title X project—physically and financially—from any abortion activities; and implemented compliance standards for family planning projects under Title X to specifically prohibit certain actions that promote or encourage, or advocate abortion as a method of family planning, such as the use of project funds for lobbying for abortion, developing and disseminating materials advocating abortion, or taking legal action to make abortion available as a method of family planning. 53 FR 2922 (Feb. 2, 1988).

The 1988 Regulations were upheld on both statutory and constitutional grounds by the United States Supreme Court in Rust v. Sullivan, 500 U.S. 173 (1991)

amily planning, such as the use of project funds for lobbying for abortion, developing and disseminating materials advocating abortion, or taking legal action to make abortion available as a method of family planning. 53 FR 2922 (Feb. 2, 1988).

The 1988 Regulations were upheld on both statutory and constitutional grounds by the United States Supreme Court in Rust v. Sullivan, 500 U.S. 173 (1991). The Court first rejected the claim that the regulations violated the Administrative Procedure Act. Under Chevron U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837 (1984), the Supreme Court reasoned that “substantial deference” was owed “to the interpretation of the authorizing statute by the agency authorized with administering it.” Rust, 500 U.S. at 184. Applying that framework, the Court concluded that—although the language of section 1008 did not speak directly to the issues of counseling, referral, advocacy, or program integrity—because the “broad language of Title X plainly allows the Secretary's construction of the statute, . . . we are unable to say that the Secretary's construction of the prohibition in § 1008 to require a ban on counseling, referral, and advocacy within the Title X project is impermissible.” Id. The Court similarly declined to view the regulations skeptically because they represented a change in policy; instead, it noted that it “has rejected the argument that an agency's interpretation `is not entitled to deference because it represents a sharp break with prior interpretation' of the statute in question.” Id. at 186-87. Accordingly, it reaffirmed that “[a]n agency is not required to `establish rules of conduct to last forever,' but rather `must be given ample latitude to `adapt [its] rules and policies to the demands of changing circumstances.' ” Id. (internal citations omitted)

`is not entitled to deference because it represents a sharp break with prior interpretation' of the statute in question.” Id. at 186-87. Accordingly, it reaffirmed that “[a]n agency is not required to `establish rules of conduct to last forever,' but rather `must be given ample latitude to `adapt [its] rules and policies to the demands of changing circumstances.' ” Id. (internal citations omitted). Finally, the Supreme Court concluded that the regulations' “program integrity” requirements—the portions of the regulations mandating separate facilities, personnel, and records—were “based on a permissible construction of the statute and are not inconsistent with congressional intent.” Id. at 188. On the contrary, the court noted, “if one thing is clear from the legislative history, it is that Congress intended that Title X funds be kept separate and distinct from abortion-related activities. . . . Certainly, the Secretary's interpretation of the statute that separate facilities are necessary, especially in light of the express prohibition of § 1008, cannot be judged unreasonable.” Id. at 190. Accordingly, the Court “defer[red] to the Secretary's reasoned determination Id.

The Supreme Court similarly rejected constitutional challenges to the regulations. As an initial matter, it upheld the statutory limitation of Title X funds to programs where abortion is not a method of family planning, concluding that “[t]here is no question but that the statutory prohibition contained in § 1008 is constitutional” because Congress “may `make a value judgment favoring childbirth over abortion and . . . implement that judgment by the allocation of public funds.' ” Rust, 500 U.S. at 192 (internal citations omitted; ellipsis in original)

to programs where abortion is not a method of family planning, concluding that “[t]here is no question but that the statutory prohibition contained in § 1008 is constitutional” because Congress “may `make a value judgment favoring childbirth over abortion and . . . implement that judgment by the allocation of public funds.' ” Rust, 500 U.S. at 192 (internal citations omitted; ellipsis in original). The Court explained that the counseling and referral provisions were consistent with the First Amendment as follows:

The challenged regulations implement the statutory prohibition by prohibiting counseling, referral, and the provision of information regarding abortion as a method of family planning. They are designed to ensure that the limits of the federal program are observed. The Title X program is designed not for prenatal care, but to encourage family planning. A doctor who wished to offer prenatal care to a project patient who became pregnant could properly be prohibited from doing so because such service is outside the scope of the federally funded program. The regulations prohibiting abortion counseling and referral are of the same ilk. . . . This is not a case of the Government `suppressing a dangerous idea,' but of a prohibition on a project grantee or its employees from engaging in activities outside of the project's scope.

Rust, 500 U.S. at 193-94. The Court also explained that the requirement of physical and financial program separation was consistent with the First Amendment as follows: By requiring that the Title X grantee engage in abortion-related activity separately from activity receiving federal funding, Congress has, consistent with our teachings . . . not denied it the right to engage in abortion-related activities. Congress has merely refused to fund such activities out of the public fisc, and the Secretary has simply required a certain degree of separation from the Title X project in order to ensure the integrity of the federally funded program.

Rust, 500 U.S. at 198

ceiving federal funding, Congress has, consistent with our teachings . . . not denied it the right to engage in abortion-related activities. Congress has merely refused to fund such activities out of the public fisc, and the Secretary has simply required a certain degree of separation from the Title X project in order to ensure the integrity of the federally funded program.

Rust, 500 U.S. at 198. Finally, the Court held that the regulations did not violate any Fifth Amendment rights because the “Government has no constitutional duty to subsidize an activity merely because the activity is constitutionally protected and [Congress] may validly choose to fund childbirth over abortion and `implement that judgment by the allocation of public funds' for medical services relating to childbirth but not to those relating to abortion.” Id. at 201 (internal quotations omitted). The Court, thus, held that the regulations “are a permissible construction of Title X and do not violate either the First or Fifth Amendments to the Constitution.” Id. at 203. 2. Suspension of 1988 Regulations and Finalization of 2000 Regulations

The 1988 Regulations continued to govern the Title X program until February 5, 1993, when a new Administration suspended them pursuant to a Presidential Memorandum and issued a proposed regulation, 58 FR 7464, that it finalized seven years later, see 65 FR 41270 (July 3, 2000) (the “2000 Regulations”). The 2000 Regulations essentially returned to the 1981 Regulations (with one revision), which eliminated provisions (a) prohibiting Title X projects from counseling or referring project clients for abortion as a method of family planning; (b) requiring grantees to separate their Title X project physically and financially from any abortion activities; and (c) implementing compliance standards for family planning projects under Title X that specifically prohibit certain actions designed broadly to promote or encourage abortion as a method of family planning, such as the use of project funds to lobby for aborti

hod of family planning; (b) requiring grantees to separate their Title X project physically and financially from any abortion activities; and (c) implementing compliance standards for family planning projects under Title X that specifically prohibit certain actions designed broadly to promote or encourage abortion as a method of family planning, such as the use of project funds to lobby for abortion, to develop and disseminate materials advocating abortion, or to take legal action to make abortion available as a method of family planning. While a contemporaneous notice stated that more than separate bookkeeping entries and allocation of funds were necessary to separate Title X project activities from non-Title X abortion activities, it discussed and approved shared facilities, staff, and records, as long as costs were pro-rated and properly allocated. See Provision of Abortion-Related Services in Family Planning Service Projects, 65 FR 41281, 41282 (July 3, 2000). The 2000 Regulations also affirmatively required that Title X providers counsel on, and refer for, abortion at the request of a Title X client.

Finally, the 2000 Regulations “incorporated in the regulatory text the policies relating to nondirective counseling and referral of the 1981 Program Guidelines for Project Grants for Family Planning Services [1981 Guidelines].” 65 FR at 41271. Those 1981 Guidelines, for the first time, required nondirective counseling about pregnancy options, including abortion, and did so in a way that “creat[ed] the appearance of treating each option identically,” despite the statutory prohibition on funding programs where abortion is a method of family planning. See 53 FR at 2923 (discussing requirements imposed by 1981 guidelines).

FR at 41271. Those 1981 Guidelines, for the first time, required nondirective counseling about pregnancy options, including abortion, and did so in a way that “creat[ed] the appearance of treating each option identically,” despite the statutory prohibition on funding programs where abortion is a method of family planning. See 53 FR at 2923 (discussing requirements imposed by 1981 guidelines).

3. 2016 Regulation

On December 19, 2016, the Department finalized a rule that amended Title X eligibility requirements, requiring that no grantee/recipient making subawards for the provision of services as part of its Title X project prohibit an entity from receiving a subaward for reasons other than its ability to provide Title X services. 81 FR 91852 (Dec. 19, 2016) (the “2016 Regulation”). The Department's stated reason for issuing the rule was to respond to new approaches to competing or distributing Title X funds that were being employed by several states. To that end, the Department asserted that “[a]llowing project recipients, including states and other entities, to impose restrictions on subrecipients for reasons other than their ability to provide Title X services has been shown to have an adverse effect on the number of people receiving Title X services and the fundamental goals of the Title X program.”

Yet the 2016 Regulation, if implemented, would have entailed certain adverse consequences. As an initial matter, it would have denied States and other grantees the freedom to choose subrecipients as they saw fit, within the Title X statutory parameters. Moreover, it could have resulted in the discontinuation of funding for entire States. A comment from the chief legal officers and/or governors from nine States explained their opposition to the rule as follows: “[The purpose of Title X is] to promote and assist in the establishment of voluntary family planning projects that offer a broad range of acceptable and effective family planning methods and services

it could have resulted in the discontinuation of funding for entire States. A comment from the chief legal officers and/or governors from nine States explained their opposition to the rule as follows: “[The purpose of Title X is] to promote and assist in the establishment of voluntary family planning projects that offer a broad range of acceptable and effective family planning methods and services. The program is also targeted toward services for adolescents. This rule does not further that goal; but rather it is intended to protect funding for certain providers even at the expense of the entire program.”

The 2016 Regulation took effect on January 18, 2017, but was nullified under the Congressional Review Act less than three months later. The President signed Public Law 115-23, “Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the final rule submitted by Secretary of Health and Human Services relating to compliance with Title X requirements by project recipients in selecting subrecipients” on April 13, 2017. As a result, the 2016 Regulation must be “treated as though such rule had never taken effect.” 5

II. Need for Change

The Department must consider the effectiveness of its policies enforcing statutory mandates on a continuing basis. As the Supreme Court noted in Rust v. Sullivan, an agency is not required to establish rules of conduct to last forever, but rather must be given ample latitude to adapt its rules and policies to the demands of changing circumstances. 500 U.S. 173, 186-87 (1991). “Agencies are free to change their existing policies as long as they provide a reasoned explanation for the change.” Encino Motorcars, LLC v. Navarro, 136 S. Ct. 2117, 2125 (2016)

van, an agency is not required to establish rules of conduct to last forever, but rather must be given ample latitude to adapt its rules and policies to the demands of changing circumstances. 500 U.S. 173, 186-87 (1991). “Agencies are free to change their existing policies as long as they provide a reasoned explanation for the change.” Encino Motorcars, LLC v. Navarro, 136 S. Ct. 2117, 2125 (2016). This “reasoned analysis” requirement does not demand that an agency “demonstrate to a court's satisfaction that the reasons for the new policy are better than the reasons for the old one; it suffices 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, which the conscious change of course adequately indicates.” U.S. Aid Funds, Inc. v. King, 200 F. Supp. 3d 163, 169-70 (D.D.C. 2016) (citing FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009)); see also New Edge Network, Inc. v. FCC, 461 F.3d 1105, 1112-13 (9th Cir. 2006) (rejecting an argument that “an agency changing its course by rescinding a rule is obligated to supply a reasoned analysis for the change beyond that which may be required when an agency does not act in the first instance”).

The Department now believes the policies outlined in this proposed rule are based on the best interpretation of, and provide appropriate guidance for compliance with, Title X. In particular, the Department believes that the policies outlined in this proposed rule provide for the best interpretation of section 1008 of Title X and of associated provisions, including the appropriations provisos and riders governing the Title X program

icies outlined in this proposed rule are based on the best interpretation of, and provide appropriate guidance for compliance with, Title X. In particular, the Department believes that the policies outlined in this proposed rule provide for the best interpretation of section 1008 of Title X and of associated provisions, including the appropriations provisos and riders governing the Title X program. The standards proposed here are designed to refocus the Title X program on its statutory mission—the provision of voluntary, preventive family planning services specifically designed to enable individuals to determine the number and spacing of their children—while clarifying that pregnant women must be referred for appropriate prenatal care services, rather than receiving them within a Title X project, because those services are not part of family planning services within the Title X program. See H.R. Rep. No. 91-1472 (1970), as reprinted in 3 U.S. Code Cong. & Adm. News 5068 (discussing the scope of the program).

A. Statutory Compliance

As discussed in section II.B. below, the Department interprets section 1008 to establish a broad prohibition on funding, directly or indirectly, activities related to abortion as a method of family planning. Thus, the Department believes that section 1008's mandate is most clearly met where there is a clear separation between Title X programs and programs in which abortion is presented or provided as a method of family planning. The 2000 regulations are inconsistent with that interpretation insofar as they require referral for abortion, allow the use of funds for infrastructure building that could be used for abortion services, and do not require clear physical and financial separation between Title X activities and abortion-related services

ograms in which abortion is presented or provided as a method of family planning. The 2000 regulations are inconsistent with that interpretation insofar as they require referral for abortion, allow the use of funds for infrastructure building that could be used for abortion services, and do not require clear physical and financial separation between Title X activities and abortion-related services. In addition, the regulations do not ensure transparency and accountability in the use of taxpayer funds insofar as they fail to provide the Department information about subrecipients, to ensure monitoring for potential misuse of funds, and to address expressly federal laws (including a Title X specific appropriations proviso) that prohibit the use of taxpayer funds for political activity or lobbying. Finally, the regulations prescribe inadequate grant criteria for selecting recipients of Title X funds who will comply with all of these requirements. If finalized and implemented as proposed, the new regulations would contribute to more clients being served, gaps in service being closed, and improved client care that better focuses on the family planning mission of the Title X program.

B. Ensuring That Title X Funds Are Not Used in Projects Where Abortion Is a Method of Family Planning

As part of its ongoing obligation to ensure compliance with federal law, the Department has determined that the existing regulations do not ensure compliance with the prohibition in section 1008 that “none of the funds appropriated” for Title X “be used in programs where abortion is a method of family planning.” In the view of the Department, that prohibition includes any action that directly or indirectly facilitates, encourages, or supports in any way the use of abortion as a method of family planning. That interpretation follows from the text and purpose of the statute.

To begin, section 1008 “broad[ly]” “prohibits the use of Title X funds `in programs where abortion is a method of family planning.' ” Rust, 500 U.S. at 184

rtment, that prohibition includes any action that directly or indirectly facilitates, encourages, or supports in any way the use of abortion as a method of family planning. That interpretation follows from the text and purpose of the statute.

To begin, section 1008 “broad[ly]” “prohibits the use of Title X funds `in programs where abortion is a method of family planning.' ” Rust, 500 U.S. at 184. Although Title X does not define “method of family planning,” the ordinary meaning of that phrase, coupled with the statutory examples of “natural family planning methods” and “infertility services,” 42 U.S.C. 300(a), suggests decisions about the number and spacing of one's children. This interpretation is consistent with the Title X regulation's description of the purpose of the program. See 42 CFR 59.1 (Title X voluntary family planning “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.”). And the exclusion of funding for abortion as a method for such decisions “embodies a view that abortion is inappropriate as a method of family planning.” 53 FR 2922, 2922 (Feb. 2, 1988). Congress, thus, chose to fund Title X programs/projects that offer only preconception methods of family planning and “create[d] a wall of separation between” those programs and others where abortion is “a method of family planning.” 53 FR at 2922. The text of Title X's prohibition is also notably broad in prohibiting funding not only for providing and promoting abortion itself as a method of family planning, but in prohibiting funding for any program “where abortion is a method of family planning”—even if funds spent on such a program could be insulated from the provision or promotion of abortion.

The legislative history confirms this meaning

text of Title X's prohibition is also notably broad in prohibiting funding not only for providing and promoting abortion itself as a method of family planning, but in prohibiting funding for any program “where abortion is a method of family planning”—even if funds spent on such a program could be insulated from the provision or promotion of abortion.

The legislative history confirms this meaning. The Conference Report stated that “[i]t is, and has been, the intent of both Houses that the funds authorized under this legislation be used only to support preventive family planning services, population research, infertility services, and other related medical, information and education activities.” H.R. Conf. Rep. No. 91-1667 at 8 (1970). Congressman John D. Dingell, Jr., the principal sponsor of section 1008, further explained on the floor of the House:

I set forth in my extended remarks the reasons why I offered to the amendment [sic], which prohibited abortion as a method of family planning. . . . With the “prohibition of abortion”, the committee members clearly intended that abortion is not to be encouraged or promoted in any way through this legislation. Programs that include abortion as a method of family planning are

116 Cong. Rec. 37375 (1970). To give effect to Section 1008, the Department now considers it important and appropriate to draw a wall of separation between Title X programs and prohibited activities. Title X programs may not directly or indirectly facilitate, promote, or encourage abortion in any way. For example, referral is an integral part of the provision of any method of family planning. When provided for abortion, a referral necessarily treats abortion as a method of family planning and runs afoul of the statute. Similarly, Title X programs that subsidize other programs where abortion is a method of family planning, through infrastructure building, cost sharing, or otherwise, run afoul of the statute

referral is an integral part of the provision of any method of family planning. When provided for abortion, a referral necessarily treats abortion as a method of family planning and runs afoul of the statute. Similarly, Title X programs that subsidize other programs where abortion is a method of family planning, through infrastructure building, cost sharing, or otherwise, run afoul of the statute. Congress made clear that “none” of the Title X funds should go to support such programs.

The Department previously took the position, in a notice published concurrently with the 2000 Regulations, that section 1008 precluded only funding of activities that “directly facilitate the use of abortion as a method of family planning, such as providing transportation for an abortion, explaining and obtaining signed abortion consent forms from clients interested in abortions, negotiating a reduction in fees for an abortion, and scheduling or arranging for the performance of an abortion, promoting or advocating abortion within Title X program activities, or failing to preserve sufficient separation between Title X program activities and abortion-related activities.” Provision of Abortion-Related Services in Family Planning Services Projects, 65 FR 41281 (July 3, 2000) (“Notice”). The Department mandated that providers provide counseling on and referral for abortion, if requested by the client.

But the Department no longer considers that position appropriate in light of restrictions set forth in the statute. Section 1008 does not merely prohibit “direct” funding for abortion. It prohibits all funding for programs “where abortion is a method of family planning.” That broad language captures not just the activities of the program itself, but also any activities facilitated, encouraged, or promoted by the program

onger considers that position appropriate in light of restrictions set forth in the statute. Section 1008 does not merely prohibit “direct” funding for abortion. It prohibits all funding for programs “where abortion is a method of family planning.” That broad language captures not just the activities of the program itself, but also any activities facilitated, encouraged, or promoted by the program. Limiting section 1008's prohibition to only “direct” facilitation of abortion creates confusion about which activities are proscribed by the section, and, in the Department's view, fails to ensure that Title X funds are not being used in “programs where abortion is a method of family planning.” The Department's previous view was erroneous in requiring counseling and referral for abortion, allowing the sharing of physical space, and permitting infrastructure building when physical space could be shared. In these proposed regulations, the Department proposes to correct all three errors.

1. Abortion Counseling and Referral Requirement

As discussed above, the Department has concluded the requirement under 42 CFR 59.5(a)(5) that a project must provide abortion counseling and referrals to pregnant women upon request is inconsistent with section 1008. 7 That requirement appears to be premised on the notion that the statute is neutral on the question whether Title X funds may be used to encourage or promote abortion. But the Department rejects that notion: “Family planning,” as clearly manifested by the text of Title X and bolstered by its legislative history, refers to activities with the purpose of facilitating the initiation of, or preventing, pregnancy, not terminating it. 8 Understood in context, referral activities are integral parts of the provision of any method of family planning. Thus, Section 1008 prohibits a Title X grantee, within the scope of the Title X project, from referring for abortion as a method of family planning

gislative history, refers to activities with the purpose of facilitating the initiation of, or preventing, pregnancy, not terminating it. 8 Understood in context, referral activities are integral parts of the provision of any method of family planning. Thus, Section 1008 prohibits a Title X grantee, within the scope of the Title X project, from referring for abortion as a method of family planning. In the 2000 regulation, the Department took the position that the statute's requirement that pregnancy counseling be nondirective justified imposing a regulatory requirement of abortion referral upon request. The Department now believes this view was erroneous. Referrals for abortion are, by definition, directive. Therefore, such referral activity is inconsistent with the prohibition on abortion as a method of family planning in Section 1008.

7 As described in the preamble to the 1988 Regulations, 53 FR at 2923, prior to issuance of any regulations pursuant to Title X, the Department had, since 1972, interpreted section 1008 not only as prohibiting the provision of abortion but also as prohibiting Title X projects from in any way promoting or encouraging abortion as a method of family planning. Further, based on the legislative history, the Department had also, since 1972, interpreted section 1008 as requiring that the Title X program be “separate and distinct” from any abortion activities of a grantee. However, in such interpretations, the Department generally took the view that activity that did not have the immediate effect of promoting abortion, or which did not have the principal purpose or effect of promoting abortion, was permitted. Id.

8 Put differently, the family planning services covered by Title X are almost exclusively preconception services, while abortion is not

ies of a grantee. However, in such interpretations, the Department generally took the view that activity that did not have the immediate effect of promoting abortion, or which did not have the principal purpose or effect of promoting abortion, was permitted. Id.

8 Put differently, the family planning services covered by Title X are almost exclusively preconception services, while abortion is not.

In addition, the requirement that Title X projects offer pregnant women the opportunity to be provided information and counseling regarding, and referrals for, abortion is inconsistent with the conscience protections embodied in the Church, Coats-Snowe, and Weldon Amendments. See 42 U.S.C. 300a-7; PHS Act sec. 245, 42 U.S.C. 238n; Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 507(d), 132 Stat. 348, 764 (2018); Consolidated Appropriations Act, 2017, Public Law 115-31, Div. 507(d), 131 Stat. 135, 562 (2017). The Department acknowledged this problem in the preamble to 2008 regulations implementing these conscience protections. Ensuring that Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law; Final Rule, 73 FR 78072 (Dec. 19, 2008). Responding to commenters who suggested that enforcing the conscience statutes would be inconsistent with the abortion referral requirements for family planning clinics in the Title X regulations, the Department observed, “[w]ith regards to the Title X program, Commenters are correct that the current regulatory requirement that grantees must provide counseling and referrals for abortion upon request (42 CFR 59.5(a)(5)) is inconsistent with the health care provider conscience protection statutory provisions and this regulation. The Office of Population Affairs, which administers the Title X program, is aware of this conflict with the statutory requirements and, as such, would not enforce this Title X regulatory requirement on objecting grantees or applicants.” 73 FR at 78087

rtion upon request (42 CFR 59.5(a)(5)) is inconsistent with the health care provider conscience protection statutory provisions and this regulation. The Office of Population Affairs, which administers the Title X program, is aware of this conflict with the statutory requirements and, as such, would not enforce this Title X regulatory requirement on objecting grantees or applicants.” 73 FR at 78087. 9 Although those 2008 conscience statute regulations were partially repealed in 2011, 76 FR 9968 (February 23, 2011), the underlying statutes remain valid and in place, and the reasoning in the preamble to the 2008 regulations on this point remains persuasive. The abortion referral and counseling requirements in the current Title X regulations, thus, cannot be enforced against objecting grantees or applicants, and such requirements cannot be used to deny participation in the Title X program or a Title X project of objecting family planning providers. 10

9 In January 2018, the Department issued a notice of proposed rulemaking to revise and expand these regulations. See Protecting Statutory Conscience Rights in Health Care; Delegation of Authority, 83 FR 3880 (Jan. 26, 2018).

10 We note that the Department has recently received a letter from the Attorney General of the State of Texas alleging discrimination against the State of Texas with respect to Title X, contending that the Department had improperly removed Texas from the list of eligible Title X grant recipients and referencing the protections embodied in the Church, Hyde/Weldon, and Coats/Snowe Amendments. Attorney General of Texas, Letter on Discrimination Against Texas Regarding Title X https://www.texasattorneygeneral.gov/files/epress/Texas_AG_letter_to_HHS_regarding_Title_X.pdf?cachebuster:96.

For these reasons, the Department proposes to change the Title X regulations to eliminate the requirement that Title X projects provide abortion referral and counseling

eldon, and Coats/Snowe Amendments. Attorney General of Texas, Letter on Discrimination Against Texas Regarding Title X https://www.texasattorneygeneral.gov/files/epress/Texas_AG_letter_to_HHS_regarding_Title_X.pdf?cachebuster:96.

For these reasons, the Department proposes to change the Title X regulations to eliminate the requirement that Title X projects provide abortion referral and counseling. In addition, consistent with the purpose of the program, the proposed rule would prohibit recipients from using Title X funds to perform, promote, refer for, or support abortion as a method of family planning. This rule would better align with both the best reading of section 1008 and with the Federal conscience statutes. Recognizing, however, the duty of a physician to promote patient safety, a doctor would be permitted to provide nondirective counseling on abortion. 11 Such nondirective counseling would not be considered encouragement, promotion, or advocacy of abortion as a method of family planning, as prohibited under section 59.16 of this proposed rule. Moreover, as permitted by the 1988 Regulations, a doctor would be permitted to provide a list of licensed, qualified, comprehensive health service providers, some (but not all) of which provide abortion in addition to comprehensive prenatal care. Providing such a list would be permitted only if a woman who is currently pregnant clearly states that she has already decided to have an abortion. This is discussed in more detail below, and the Department seeks public comment on this issue.

11 That counseling on abortion be nondirective is required by the appropriations law applicable to Title X. See Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, 132 Stat. at 716-17 (“all pregnancy counseling shall be nondirective”).

s already decided to have an abortion. This is discussed in more detail below, and the Department seeks public comment on this issue.

2. Possible Co-Mingling of Funds Between Title X Projects and the Abortion Activities of the Title X Grantee/Subrecipient

A second statutory problem is raised by the fact that the 2000 Regulations required financial, but not physical, separation between Title X Projects and the abortion activities of the Title X grantee/subrecipient. Organizations that actively include abortion as a method of family planning have consistently received Title X funding. The 2000 regulations permit shared facilities, common staff, and single file systems between Title X supported activities and non-Title X abortion-related activities in the following ways:

(a) A common waiting room is permissible, as long as the costs [are] properly pro-rated; (b) common staff is permissible, so long as salaries are properly allocated and all abortion related activities of the staff members are performed in a program which is entirely separate from the Title X project; (c) a hospital offering abortions for family planning purposes and also housing a Title X project is permissible, as long as the abortion activities are sufficiently separate from the Title X project; and (d) maintenance of a single file system for abortion and family planning patients is permissible, so long as costs are properly allocated. 65 FR 41281, 41282 (July 3, 2000).

patients is permissible, so long as costs are properly allocated. 65 FR 41281, 41282 (July 3, 2000).

These shared facilities create a risk of the intentional or unintentional use of Title X funds for impermissible purposes, the co-mingling of Title X funds, and the appearance and perception that Title X funds being used in a given program may also be supporting that program's abortion activities. Even with the strictest accounting and charging of expenses, a shared facility greatly increases the risk of confusion and the likelihood that a violation of the Title X prohibition will occur. This concern is particularly acute in light of more recent evidence that abortions are increasingly performed at sites that focus primarily on contraceptive and family planning services—sites that could themselves be recipients of Title X funds. The Guttmacher Institute's recent report, Abortion Incidence and Service Availability in the United States, 2014, provides detail about the various types of facilities at which abortions are performed. It notes that “nonspecialized clinics”— i.e., “nonhospital sites in which fewer than half of patient visits are for abortion services,” including physicians' offices—may provide 400 or more abortions per site per year. The report notes that, “[w]hile many of these [nonspecialized] clinics primarily serve contraceptive and family planning clients, about half provided 400 or more abortions per year.” It defines “abortion clinics” as “nonhospital facilities in which half or more of patient visits are for abortion services, regardless of annual abortion caseload.” According to the Guttmacher Institute, nonspecialized clinics accounted for 24% of all abortions in 2008; 12 31% in 2011; 13 and 36% in 2014. 14 In addition, nonspecialized clinics represented 26% of abortion providers in 2008; 30% in 2011; and 31% in 2014

clinics” as “nonhospital facilities in which half or more of patient visits are for abortion services, regardless of annual abortion caseload.” According to the Guttmacher Institute, nonspecialized clinics accounted for 24% of all abortions in 2008; 12 31% in 2011; 13 and 36% in 2014. 14 In addition, nonspecialized clinics represented 26% of abortion providers in 2008; 30% in 2011; and 31% in 2014. Further, despite a 3% drop in the total number of abortion facilities between 2011 and 2014, the number of abortion clinics dropped by 17%, while the number of nonspecialized clinics performing abortions remained stable. The performance of abortions at nonspecialized clinics that also may provide Title X services increases the risk and potential both for confusion and for the co-mingling or misuse of Title X funds.

12 Jones, R.K., Kooistra, K., Abortion incidence and access to services in the United States, 2008, Guttmacher Institute Perspectives on Sexual and Reproductive Health (Jan. 10, 2011), https://www.guttmacher.org/sites/default/files/article_files/4304111.pdf.

13 Jones, R.K., Jerman, J., Abortion incidence and service availability in the United States, 2011, Guttmacher Institute Perspectives on Sexual and Reproductive Health (Feb. 3, 2014), https://www.guttmacher.org/sites/default/files/article_files/abortion_incidence_in_the_united_states_2011.pdf.

14 Jones, R.K., Jerman, J., Abortion incidence and service availability in the United States, 2014, Guttmacher Institute Perspectives on Sexual and Reproductive Health (Jan. 17, 2017), https://www.guttmacher.org/sites/default/files/article_files/abortion-incidence-us.pdf

(Feb. 3, 2014), https://www.guttmacher.org/sites/default/files/article_files/abortion_incidence_in_the_united_states_2011.pdf.

Together, these circumstances create a risk of intentional or unintentional misuse of Title X funds and have created public confusion over the scope of Title X services, whether Title X projects provide abortion services, and whether the Federal government (and, ultimately, Federal taxpayers), is funding abortion services provided by organizations that are recipients (or subrecipients) of Title X grants/funds. The Department believes that such potential co-mingling and confusion is evidence that the 2000 Regulations neither adequately reflect nor further the text and purpose of section 1008. As discussed above, the Department interprets section 1008 to require Title X project activities to be separate and distinct from non-Title X abortion activities. Thus, when a grantee conducts abortion activities that are not part of the Title X project, and would not be permissible if they were, the grantee must ensure that the Title X-supported project is separate and distinguishable from those other activities.

The proposed regulation would reduce, and potentially eliminate, any confusion—actual or potential—as to the scope of services supported by Title X funds by requiring Title X projects to maintain clear physical and financial program separation from programs that use abortion as a method of family planning. This bright-line rule would create a clearer, more transparent system of separation and accountability, similar to that established by the 1988 Regulations and affirmed by the Supreme Court in Rust

the scope of services supported by Title X funds by requiring Title X projects to maintain clear physical and financial program separation from programs that use abortion as a method of family planning. This bright-line rule would create a clearer, more transparent system of separation and accountability, similar to that established by the 1988 Regulations and affirmed by the Supreme Court in Rust. It would also assure fidelity to the text and purpose of section 1008, and facilitate auditing and enforcement of program requirements. The proposed rule would not, however, restrict the use of non-Title X funds outside the Title X program, nor would it impose restrictions on funds provided by other

3. Infrastructure Building That Creates Fungibility Concerns Related to Abortion Services

The current flexibility in the use of Title X funds raises additional concerns about the fungibility of assets that could be used—sometimes with an attendant increase in marginal cost—to build infrastructure for abortion services. By law, Title X providers must secure other sources of revenue to leverage Title X grants. See 42 CFR 59.7(c) (“No grant may be made for an amount equal to 100 percent for the project's estimated costs.”). Medicaid is the primary source of additional revenue. But unlike Title X, which is a grant program, Medicaid is a reimbursement program. By their very nature, grants afford considerably greater latitude and versatility to grantees on how funds are used. If an organization receives both Medicaid and Title X funding, for example, Medicaid reimbursement payments might be used to cover many family planning services, freeing up Title X funds to be used for infrastructure-building and support. In its Moving Forward: Family Planning in the Era of Health Reform report, the Guttmacher Institute reported that providers do in fact use Title X funds in this way:

Up-front funding helps supply a cash-flow cushion for providers who are often operating on tight and uncertain budgets

cover many family planning services, freeing up Title X funds to be used for infrastructure-building and support. In its Moving Forward: Family Planning in the Era of Health Reform report, the Guttmacher Institute reported that providers do in fact use Title X funds in this way:

Up-front funding helps supply a cash-flow cushion for providers who are often operating on tight and uncertain budgets. More specifically, Title X recipients use the program's flexible grant funding in a variety of ways to address staff-related issues, including hiring individuals capable of meeting communities' need for linguistic or culturally appropriate care, training staff on the latest medical techniques or to provide tailored counseling for clients with special needs, maintaining sufficient staff to operate outside regular business hours and paying sufficient wages to staff at all levels to reduce high turnover rates that often plague health centers. Providers may also use Title X funds for operational investments, such as utilizing advanced technologies and facilitating more accessible and efficient client care . . . . Finally, Title X undergirds the infrastructure and general operations of the health centers themselves in ways that Medicaid and private insurance simply cannot. Title X funds go to centers up front as grants, rather than after the fact as reimbursement for services centers have provided to individual enrollees. Providers have long relied on that flexibility to hire, train and maintain their staff to meet the diverse needs of their clients and community. They have also depended on these grants to keep their lights on and their doors open, to adapt to unexpected budget shortfalls and to make improvements to their facilities. Such versatility is even more vital in the era of health reform

ividual enrollees. Providers have long relied on that flexibility to hire, train and maintain their staff to meet the diverse needs of their clients and community. They have also depended on these grants to keep their lights on and their doors open, to adapt to unexpected budget shortfalls and to make improvements to their facilities. Such versatility is even more vital in the era of health reform. The up-front investments in staffing, training and infrastructure needed to work effectively with health plans—and to thereby draw in new revenue to serve more clients—are substantial, and flexible funds like those provided through Title X are ideal for such investments. Those expenses include upgrading health information technology systems and training staff on their use, training clinicians and front-line staff to properly code and bill for services provided, obtaining the appropriate credentials to ensure third-party reimbursement, and devoting time and resources to researching available health plans and negotiating contracts with them. They may also include expenses related to outsourcing some administrative functions to private contractors or as part of collaborations with other health care providers. 15

15 Sonfield, A., Hasstedt, K., Gold, R. B., Moving forward. Family planning in the era of health reform, Guttmacher Institute (March 2014), https://www.guttmacher.org/report/moving-forward-family-planning-era-health-reform.

In another report, Guttmacher expanded upon the infrastructure support afforded by Title X funding: Title X can subsidize the intensive outreach necessary to encourage some individuals to seek services. Furthermore, by paying for everything from staff salaries to utility bills to medical supplies, Title X funds provide the essential infrastructure support that enables clinics to go on and claim Medicaid reimbursement for the clients they serve. 16

16 Gold, R

upport afforded by Title X funding: Title X can subsidize the intensive outreach necessary to encourage some individuals to seek services. Furthermore, by paying for everything from staff salaries to utility bills to medical supplies, Title X funds provide the essential infrastructure support that enables clinics to go on and claim Medicaid reimbursement for the clients they serve. 16

16 Gold, R. B., Stronger Together: Medicaid, Title X Bring Different Strengths to Family Planning Effort, Guttmacher Institute (May 17, 2007), https://www.guttmacher.org/gpr/2007/05/stronger-together-medicaid-title-x-bring-different-strengths-family-planning-effort.

Infrastructure building may include securing physical space, developing or acquiring health information technology systems (including electronic health records), bulk purchasing of contraceptives or other clinic supplies, clinical training for staff, and community outreach and recruiting. An anecdotal story from Guttmacher in the report Stronger Together: Medicaid, Title X Bring Different Strengths to Family Planning Effort reinforces the point:

Ibarra of California's Venice clinic says her agency sends street outreach teams into the community with backpacks of condoms and basic educational materials, while other teams make regular visits to homeless shelters. Often, it will take multiple visits to a shelter or street-corner conversations until someone feels safe enough to come to a clinic. According to Ibarra, Title X will fund and train the outreach workers, purchase the condoms and often even develop the educational materials they distribute. Only when a client actually comes to the clinic is reimbursement available (through Medicaid or any other source), and then only if the client qualifies

elter or street-corner conversations until someone feels safe enough to come to a clinic. According to Ibarra, Title X will fund and train the outreach workers, purchase the condoms and often even develop the educational materials they distribute. Only when a client actually comes to the clinic is reimbursement available (through Medicaid or any other source), and then only if the client qualifies. According to Annette Amey, director of program evaluation for CFHC, “it's all about getting people to the inside of the clinic door, and for that Title X dollars are indispensable.”

The Department is concerned about this infrastructure building on both statutory and policy grounds. As a statutory matter, the use of Title X funds to build infrastructure that can be used for purposes prohibited with these funds, such as support for the abortion business of a Title X grantee or subrecipient, clearly violates section 1008. As a policy matter, Title X is the only discrete, domestic, Federal grant program focused solely on the provision of cost-effective family planning methods and services. As the number of Americans at or below the poverty level has increased, the need to prioritize the use of Title X funds for the provision of family planning service has as well.

The proposed physical and financial separation of Title X projects from all activities that could not be funded by those programs, as well as the separate provision addressing the use of Title X funds for infrastructure purposes, would address this concern. Because Title X projects would not share any infrastructure with abortion-related activities, direction of Title X funds toward such infrastructure would no longer threaten to divert funds to impermissible activities. That separation would thus ensure that Title X funds are used for the purposes expressly mandated by Congress, that is, to offer family planning methods and services—and that any infrastructure built with Title X funds would not be used for impermissible purposes.

vities, direction of Title X funds toward such infrastructure would no longer threaten to divert funds to impermissible activities. That separation would thus ensure that Title X funds are used for the purposes expressly mandated by Congress, that is, to offer family planning methods and services—and that any infrastructure built with Title X funds would not be used for impermissible purposes.

C. Ensuring Responsible Use of Taxpayer Funds

In addition to ensuring compliance with section 1008, the Department seeks to address three additional concerns posed by the 2000 regulations with respect to the responsible use of taxpayer funds.

1. Ensuring Transparency of Subrecipients of Funds To Assist Oversight and Enforcement Efforts

Transparency in the use of governmental funds is an important principle for responsible government. This transparency helps to ensure accountability for, and wise use of, taxpayers' money. Current Title X regulations, however, do not require grantees to submit information to the government about their subrecipients, referral agencies, or other partners to whom Title X funds may flow. This lack of information is a barrier to OPA's oversight of the activities of its program

Therefore, under the new regulations, Title X grant applicants would be required to share the following within their applications and, if funded, in required reports and responses to performance measures, wherever practicable:

• Names and locations of subrecipients, referral individuals and agencies, as well as services provided and to be provided by those entities;

• Detailed descriptions of any partnerships, including the extent of collaboration, with subrecipients, referral individuals and agencies, as well as less formal partners within the community, in order to demonstrate a seamless continuum of care for clients;

• A clear explanation of how the grantee will ensure adequate oversight and accountability for quality and effectiveness outcomes among subrecipients and those who serve as referrals for ancil

g the extent of collaboration, with subrecipients, referral individuals and agencies, as well as less formal partners within the community, in order to demonstrate a seamless continuum of care for clients;

• A clear explanation of how the grantee will ensure adequate oversight and accountability for quality and effectiveness outcomes among subrecipients and those who serve as referrals for ancillary or core services.

2. Expanding Monitoring of the Use of Title X Funds

The Department has additional concerns about the potential for misuse of Title X funds and misbilling or overbilling of other Federal or state programs by Title X grantees under the current regulatory scheme. Although Title X is the only discrete domestic family planning grant program, other programs also fund family planning. In fact, 75% of all family planning services are funded through Medicaid; only 10% are funded through Title X. 17 Not infrequently, Title X grant recipients also claim Medicaid reimbursement for services they provide to clients. In fact, according to the National Family Planning & Reproductive Health Association, “Medicaid is by far the largest revenue stream for the Title X provider network, comprising 40% of an average funding mix [and] is also the fastest growing revenue stream.” 18 It is not inconsequential, then, to note cases of misuse/overbilling with respect to reimbursement for family planning services.

17 Hasstedt, K., Sonfield, A., Gold, R.B. Public funding for family planning and abortion services, FY 1980-2015, Guttmacher Institute (April 2017), https://www.guttmacher.org/report/public-funding-family-planning-abortion-services-fy-1980-2015.

18 Hays B., Title X in Context, National Family Planning & Reproductive Health Association (July 2016), https://www.nationalfamilyplanning.org/file/documents---policy-briefs/Title-X-in-Context.pdf.

Numerous studies have documented misuse/overbilling for family planning services

titute (April 2017), https://www.guttmacher.org/report/public-funding-family-planning-abortion-services-fy-1980-2015.

18 Hays B., Title X in Context, National Family Planning & Reproductive Health Association (July 2016), https://www.nationalfamilyplanning.org/file/documents---policy-briefs/Title-X-in-Context.pdf.

Numerous studies have documented misuse/overbilling for family planning services. The HHS Office of Inspector General (OIG) conducted a Federal audit of Medicaid-reimbursed claims for family planning services in New York State and found that about 25% of a sample of such claims were not eligible for Family Planning Benefit Program (FPBP) reimbursements. 19 Overall, 61 Federal audits conducted by the Department's OIG found overbilling among Medicaid providers. On average, at least 14% of the Federal share of funding was overbilled by providers, with one provider overbilling at least 54% of the Federal share. 20 Although misuse among Medicaid recipients does not necessarily predict or imply misuse of grant funds among Title X grantees, the Department is aware of specific examples of misuse/overbilling by such grantees. For example:

19 HHS OIG, Review of Federal Medicaid Claims Made for Beneficiaries in the Family Planning Benefit Program in New York State, Report No. A-02-07-01001 (May 22, 2008), https://oig.hhs.gov/oas/reports/region2/20701001.htm.

20 Foster, C.G., Profit. No Matter What, 2017 Report on Publicly Available Audits of Planned Parenthood Affiliates and State Family Planning Programs, Charlotte Lozier Institute Special Report Series 3 (Jan. 4, 2017), https://lozierinstitute.org/profit-no-matter-what.

• In New York State, one Medicaid provider was found to have received significant overpayments for family planning services. 21 The same provider, also a Title X grantee, 22 was found by the Health Resources and Services Administration (HRSA) to be in billing violation during a program integrity audit

tute Special Report Series 3 (Jan. 4, 2017), https://lozierinstitute.org/profit-no-matter-what.

21 Letter, State of New York Office of the Medicaid Inspector General, “Letter on Family Planning Chargeback to Managed Care Network Providers, Final Report, Audit # 09-1415, Provider #---,” --- (June 10, 2009).

22 Philipson, D., Letter to the editor: Title X initiative threatens to affect the well-being of our communities, The Rivertowns Enterprise (Apr. 1, 2011), https://www.plannedparenthood.org/planned-parenthood-hudson-peconic/newsroom/letter-editor-title-x-initiative-threatens-affect-well-being-our-communities-rivertowns-enterpr.

23 HRSA, Program Integrity: FY13 audit results (2017), https://www.hrsa.gov/opa/programintegrity/auditresults/fy13results.html.

• A Medicaid provider, under threat of being terminated from the Illinois Medicaid program, was charged with overbilling for birth control. 24 This same provider is a current Title X grant recipient. 25

24 Wang, A., Planned Parenthood Settles with Illinois on Medicaid Payments, Modern Healthcare (Sept. 6, 2012), http://www.modernhealthcare.com/article/20120906/INFO/309069993; Wang, A., Medicaid Probes Planned Parenthood Fees, Crain's Chicago Business (July 9, 2012), http://www.chicagobusiness.com/article/20120707/ISSUE01/307079977/medicaid-probes-planned-parenthood-of-illinois.

25 Wang, A.L., Planned Parenthood settles with Illinois on Medicaid payments, Modern Healthcare (Sept. 6, 2012) http://www.modernhealthcare.com/article/20120906/INFO/309069993; HHS Office of Population Affairs, Title X family planning directory of grantees (2017), https://www.hhs.gov/opa/title-x-family-planning/title-x-grantees/index.html

307079977/medicaid-probes-planned-parenthood-of-illinois.

• Another Title X recipient and Medicaid provider in Pennsylvania was found out of compliance by HRSA for overbilling. 26

26 HRSA, Program Integrity: FY2012 audit results (2017), https://www.hrsa.gov/opa/programintegrity/auditresults/fy12results.html.

• A Medicaid provider (and Title X grantee) in Washington State was audited following charges that it engaged in improper billing practices. The Washington Medicaid Fraud Control Unit investigated; as a result of the investigation, the grantee reimbursed the Medicaid program. 27

27 Stucke, J., Planned Parenthood undergoes leadership changes, audit, The Spokesman-Review (May 21, 2009), http://www.spokesman.com/stories/2009/may/21/planned-parenthood-undergoes-leadership-changes/. Referenced Audit # 09-04-08 of Yakima County, Washington.

• The state of Nebraska found that significant abortion-related expenses were charged against the Title X grant by a subrecipient. 28 The same subrecipient, also a Medicaid provider, was also charged with “false, fraudulent, and/or ineligible claims for reimbursement” to Medicaid. 29 In addition, a sample of 10 payments to subrecipients was reviewed by the state of Nebraska; nine of the ten lacked documentation to support Title X reimbursement

abortion-related expenses were charged against the Title X grant by a subrecipient. 28 The same subrecipient, also a Medicaid provider, was also charged with “false, fraudulent, and/or ineligible claims for reimbursement” to Medicaid. 29 In addition, a sample of 10 payments to subrecipients was reviewed by the state of Nebraska; nine of the ten lacked documentation to support Title X reimbursement. The report stated: “The Agency did not have adequate monitoring procedures to ensure payments to subrecipients were for allowable activities and costs.” 30

28 Nebraska Auditor of Public Accounts, State of Nebraska Statewide single audit: Year ended June 20, 2015 (2016), http://www.auditors.nebraska.gov/APA_Reports/2016/SA200-03242016-July_1_2014_through_June_30_2015_Statewide_Single_Report.pdf.

29 Second Amended Complaint, Thayer v. Planned Parenthood of the Heartland, No. 4:11-cv-00129 (S.D. Iowa, filed July 26, 2012).

30 Nebraska Auditor of Public Accounts, State of Nebraska Statewide single audit: Year ended June 20, 2015 (Mar. 24, 2016), http://www.auditors.nebraska.gov/APA_Reports/2016/SA200-03242016-July_1_2014_through_June_30_2015_Statewide_Single_Report.pdf.

• In Wisconsin, an audit of a Title X grantee found Medicaid overbilling problems, including no proof of prescription, excessive reimbursements beyond what is allowable, and other irregularities. 31

31 Wisconsin Department of Health Services, Audit Reveals Significant Overpayments to Family Planning Clinics (Aug. 3, 2016), https://www.dhs.wisconsin.gov/news/releases/fp-summary-results.pdf.

• In Massachusetts, a Title X grantee was subject to an OIG investigation, where the grantee admitted to comingling Title X expenses with all 32

32 HHS OIG, Audit of Tapestry Health Systems, Inc. Title X Financial Management Systems, Report No. A-01-99-01504 (May 2000), https://oig.hhs.gov/oas/reports/region1/19901504.pdf.

These examples raise concerns about the integrity of the Title X program

In Massachusetts, a Title X grantee was subject to an OIG investigation, where the grantee admitted to comingling Title X expenses with all 32

32 HHS OIG, Audit of Tapestry Health Systems, Inc. Title X Financial Management Systems, Report No. A-01-99-01504 (May 2000), https://oig.hhs.gov/oas/reports/region1/19901504.pdf.

These examples raise concerns about the integrity of the Title X program. While only a few of these cases involve documented misuse of Title X funds or violation of Title X's financial requirements, the Department is concerned these instances suggest that at least some recipients or subrecipients of Title X funds may not understand, and/or may not be in compliance with, requirements regarding the receipt or use of Federal funds, including Title X funds.

More broadly, grantees from a variety of federal programs commonly fail to verify personnel costs with the actual time spent on the grant-supported activities compared to time spent on non-grant functions by fully documenting time with personnel activity reports. In addition, it is not uncommon for project costs in federal reports to be inconsistent with time and status reports or bookkeeping ledgers, or for grantees to lack adequate documentation for the amount allocated to the grant for indirect costs. Yet infrastructure costs can benefit the organization generally, rather than only as it pertains to activities permitted under the grant project. 33

33 National Historical Publications and Records Commission, An introduction to financial management for grant recipients, National Archives (June 17, 2015) https://www.archives.gov/files/nhprc/pdfs/grant-financial-management.pdf.

The Department believes it necessary to address this issue with expanded monitoring, reporting, transparency, and accountability requirements

er the grant project. 33

The Department believes it necessary to address this issue with expanded monitoring, reporting, transparency, and accountability requirements. Because of the specific statutory prohibitions and requirements imposed on Title X projects, and the regulatory requirement—both currently and as proposed—for financial separation, the Department does not believe that the general grants management requirements are sufficient to address the issue. Rather, the Department proposes specific requirements to ensure legal and ethical usage of taxpayer dollars. These requirements are discussed in greater detail below, but they include requiring programs to: Ensure compliance with statutory requirements; have a plan in place to demonstrate that grantees and subrecipients are aware of certain reporting requirements that apply in their state; provide adequate training with respect to those requirements; maintain records about clients for whom state reporting requirements apply; receive approval for any change in the usage of grant funds; and fully account for and justify charges against the Title X grant.

3. Enforcing Other Statutory Requirements on the Use of Title X Funds

The current regulations also raise concerns about compliance with other federal laws that govern expenditures of taxpayer funds.

Requirements on the Use of Title X Funds

The current regulations also raise concerns about compliance with other federal laws that govern expenditures of taxpayer funds.

In addition to the Anti-Lobby Act, 18 U.S.C. 1913, the Department's annual appropriations act establishes a comprehensive framework prohibiting the use of Federal funding, including Title X funds, for publicity and propaganda. One set of prohibitions applies across the Executive Branch: “No part of any funds appropriated in this or any other Act shall be used by an agency of the executive branch, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, and for the preparation, distribution or use of any kit, pamphlet, booklet, publication, radio, television, or film presentation designed to support or defeat legislation pending before the Congress, except in presentation to the Congress itself.” 34 Another provision applies to federal contractors: “No part of any appropriation . . . shall be used directly or indirectly, including by private contractor, for publicity or propaganda purposes within the United States not heretofore authorized by Congress.” 35

34 Consolidated Appropriations Act, 2018, Public Law 115-141, Div. E, sec. 715, 132 Stat. 348, 590 (2018).

35 Consolidated Appropriations Act, 2018, Public Law 115-141, Div. E, sec. 718, 132 Stat. 348, 591 (2018).

Yet another provision, which expressly applies to the Departments of Labor, Health and Human Services, and Education, adds “electronic communication” and substitutes “video” for “film” in the list of prohibited media, sweeps into its ambit “any State or local legislature or legislative body,” and adds “any proposed or pending legislation, administrative action, or order issued by the executive branch of any State or local government” to the prohibited targets

ts of Labor, Health and Human Services, and Education, adds “electronic communication” and substitutes “video” for “film” in the list of prohibited media, sweeps into its ambit “any State or local legislature or legislative body,” and adds “any proposed or pending legislation, administrative action, or order issued by the executive branch of any State or local government” to the prohibited targets. 36 This prohibition is coupled with the directive that no part of the Labor, HHS, and Education appropriation “shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient” who engages in a similar list of lobbying activities. 37 The Appropriations Act also contains an explicit prohibition against the use of Title X funds “for any activity (including the publication or distribution of literature) that in any way tends to promote public support or opposition to any legislative proposal or candidate for public office. 38

36 Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 503(a), 132 Stat. 348, 762 (2018).

37 Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 503(b), 132 Stat. 348, 763 (2018).

38 Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, 132 Stat. 348, 716-717 (2018); Consolidated Appropriations Act, 2017, Pub. L. 115-31, Div. H, Title II, 131 Stat. 135, 521 (2017).

Finally, the Byrd Amendment applies to the recipients of Federal contracts, grants, or loans, as well as the funded parties to cooperative agreements. It prohibits them from using such funds to lobby in connection with the award, extension, continuation, renewal, amendment, or modification of the funding mechanism under which monetary assistance was received. 39

39 31 U.S.C. 1352(a).

The current regulations offer no guidance on the application of these restrictions to the Title X program

well as the funded parties to cooperative agreements. It prohibits them from using such funds to lobby in connection with the award, extension, continuation, renewal, amendment, or modification of the funding mechanism under which monetary assistance was received. 39

39 31 U.S.C. 1352(a).

The current regulations offer no guidance on the application of these restrictions to the Title X program. Yet these restrictions on the use of appropriated funds clearly prohibit the use of Title X funds to encourage, promote, or advocate for abortion, to support any legislative proposal that encourages abortion, or to support or oppose any candidate for public office. Without guidance from the Department, it is possible that Title X grantees could intentionally, or unintentionally and unknowingly, use Title X funds for prohibited lobbying or political activities, or use such funds to support or pay dues/association fees to organizations where a majority of funds are used for such purposes. Indeed, issues surrounding family planning and abortion are highly controversial and routinely the subject of debate and policy consideration in the political and legislative processes at the national, state and local levels. As a consequence, and even without consideration of violations of these requirements, it is important that recipients of Title X funds fully understand the statutory prohibition on the use of Federal funds for lobbying and political activity.

The proposed rule would provide more explicit direction, in requiring Title X grantees to provide a written assurance that they both understand and agree to the prohibitions related to lobbying and political activity with the use of grant funds. Because of the specific statutory prohibitions applicable to Title X, and the regulatory requirement—both currently and as

g and political activity.

D. Inadequate Grant Review Criteria

The current Title X regulations set forth application review criteria that give HHS significant flexibility in determining awards, but need to be updated to more fully ensure that successful applicants both meet the statutory requirements of the Title X program and are adequately responsive to the statutory goals and purposes of the Title X program. The statute sets forth several factors that HHS shall take into account in making grants and contracts, 40 but these factors are nonexclusive: The statute does not prohibit HHS from taking other factors into account and does not specify how much weight to attribute to each factor. The current regulations similarly contain a non-exclusive list of application review criteria—which include, but go beyond the statutory criteria—and do not specify how much weight to attach to each factor, giving HHS discretion to vary the weighting of the criteria in its competitions.

40 Title X provides that, “[i]n making grants and contracts under this section the Secretary shall take into account the number of patients to be served, the extent to which family planning services are needed locally, the relative need of the applicant and its capacity to make rapid and effective use of such assistance.” PHS Act Sec. 1001(b); 42 U.S.C. 300(b)

f the criteria in its competitions.

As a result, while the statute and current regulations give HHS discretion in considering and weighting factors, the application review criteria in the regulation could be more comprehensive and rigorous, so that the strongest prospective grantees are more likely to be selected, and less qualified applicants would be less likely to garner high scores. The Department is focused on ensuring compliance with the statutory Title X requirements ( see 42 U.S.C. 300-300a-6; Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, secs. 207-08, 132 Stat. 348, 716-17, 736), including the program integrity provisions referenced elsewhere herein; expanding the type and nature of the Title X providers and ensuring the diversity of such providers, so as to fill gaps in and expand family planning services offered through Title X; and using review criteria as a meaningful instrument to assess the quality of the applicant and the application. These goals, which are consistent with the statute and permissible under the existing regulations, would be best achieved by amending the regulations to more fully specify the application criteria, while still adhering to the statutory requirement that certain factors be considered and maintaining the Department's flexibility to consider other factors in making awards.

Therefore, through the proposed rule, the Department seeks to achieve a two-fold goal:

1. Update application review criteria to better achieve the statutory requirements and goals of Title X.

the application criteria, while still adhering to the statutory requirement that certain factors be considered and maintaining the Department's flexibility to consider other factors in making awards.

Therefore, through the proposed rule, the Department seeks to achieve a two-fold goal:

1. Update application review criteria to better achieve the statutory requirements and goals of Title X.

2. Increase competition and rigor among applicants, encouraging broader and more diverse applicants and better ensuring the selection of quality applicants.

The Department and OPA desire to award grants for the establishment and operation of those Title X projects that would best promote the purposes of Title X and meet the statutory requirements.

The Department proposes revising the current application review criteria at 45 CFR 59.7 through this rulemaking process to establish the following criteria for selection of Title X grantees. Under this proposed regulation, any grant applications that do not clearly address how the proposal will satisfy the requirements of the regulation would not proceed to the competitive review process, but would be deemed ineligible for funding. The Department would explicitly summarize each provision of the regulation (or include the entire regulation) within the Funding Announcement, and would require applicants to describe their affirmative compliance with each provision. If a proposal is deemed compliant with the regulation, then applicants would be rated based on at least the following criteria for selection within the competitive grant review process:

explicitly summarize each provision of the regulation (or include the entire regulation) within the Funding Announcement, and would require applicants to describe their affirmative compliance with each provision. If a proposal is deemed compliant with the regulation, then applicants would be rated based on at least the following criteria for selection within the competitive grant review process:

(1) The degree to which the applicant's project plan adheres to the Title X statutory purpose and goals for the “establishment and operation of voluntary family planning projects which shall offer a broad range of acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services for adolescents)” (PHS Act Sec. 1001(a), 42 U.S.C. 300(a)), which meet all of the statutory and regulatory requirements and restrictions, and where “none of the funds . . . shall be used in programs where abortion is a method of family planning.” (PHS Act Sec. 1008, 42 U.S.C. 300a-6).

(2) The degree to which “the relative need of the applicant” (PHS Act Sec. 1001(b), 42 U.S.C. 300(b)) is demonstrated in the proposal, and the applicant shows capacity to “make rapid and effective use” (PHS Act Sec. 1001(b), 42 U.S.C. 300(b)), of grant funds, including and especially among a broad range of partners and diverse subrecipients and referral individuals and organizations, and among non-traditional Title X partnering organizations.

(3) The degree to which the applicant takes into account “the number of patients to be served” (PHS Act Sec. 1001(b), 42 U.S.C. 300(b)), while also targeting areas that are more sparsely populated and/or places in which there are not adequate family planning services available.

subrecipients and referral individuals and organizations, and among non-traditional Title X partnering organizations.

(4) “The extent to which family planning services are needed locally” (PHS Act Sec.1001(b), 42 U.S.C. 300(b)) and the applicant proposes innovative ways to provide services to unserved or underserved patients.

The Department seeks public comment as to whether additional regulatory application review criteria may be necessary or advisable to implement the Department's interpretation of the statutory provisions applicable to Title X, in particular section 1008; to protect the rights of individuals and entities who decline to participate in abortion-related activities; or to ensure that all services funded through Title X offer optimal health benefits to clients of all ages. The Department also seeks public comment as to whether the protections and services funded through Title X are adequately implemented and clearly understood throughout the Title X program, in order to alleviate the current confusion, and avoid future confusion, among clients and the general public.

III. Statutory Authorities

The Department has legal authority to amend Title X regulations on the requirements applicable to projects for family planning services under section 1006 of the Public Health Service Act, 42 U.S.C. 300a-4. Section 1006 of the Act states that “[g]rants and contracts made under this title shall be made in accordance with such regulations as the Secretary may promulgate.” The Department has repeatedly exercised that authority to issue regulations to guide Title X grantees in carrying out the program

ects for family planning services under section 1006 of the Public Health Service Act, 42 U.S.C. 300a-4. Section 1006 of the Act states that “[g]rants and contracts made under this title shall be made in accordance with such regulations as the Secretary may promulgate.” The Department has repeatedly exercised that authority to issue regulations to guide Title X grantees in carrying out the program.

The proposed regulations described below in the section-by-section discussion of the proposed rule would clarify, require compliance with, and provide for the enforcement of, statutory limitations and requirements placed on Title X projects and grantees. These See, e.g., Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, 132 Stat. 348, 716 (2018); Consolidated Appropriations Act, 2017, Public Law 115-31, Div. H, Title II, 131 Stat. 135, 521 (2017); Consolidated Appropriations Act, 2016, Public Law 114-113, Div. H, Title II, 129 Stat. 2242, 2602 (2015). They also include annual appropriations provisions directing that “all pregnancy counseling shall be nondirective” 41 and that Title X funds “shall not be expended for any activity (including the publication or distribution of literature) that in any way tends to promote public support or opposition to any legislative proposal or candidate for public office.” 42 See, e.g., Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, 132 Stat. 348, 716-717 (2018).

41 Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, 132 Stat. 348, 716 (2018). Nondirective counseling has been described in Congressional proceedings and debates throughout the years. For example, “nondirective counseling is the provision of information on all available options without promoting, advocating, or encouraging one option over another.” Congressional Record (1992, April 30). Family Planning Amendments Act of 1991, House of Representatives. 138 Cong. Rec. H2822-02, 1992 WL 86830

nseling has been described in Congressional proceedings and debates throughout the years. For example, “nondirective counseling is the provision of information on all available options without promoting, advocating, or encouraging one option over another.” Congressional Record (1992, April 30). Family Planning Amendments Act of 1991, House of Representatives. 138 Cong. Rec. H2822-02, 1992 WL 86830. Non-directive counseling does not mean the Title X provider or counselor is uninvolved in the process, nor does it mean that counseling and education offer no direction, but that clients take an active role in processing their experiences and identifying the direction of the interaction. The Title X provider/counselor promotes the client's self-awareness and empowers the client to change and develop agency over personal circumstances, offering a range of options, consistent with the client's expressed need and with the statutory and regulatory requirements governing the Title X program.

42 Public Law 107-116, Title II, 115 Stat. 2177, 2186 (2002). .

The proposed regulations also would require compliance with, and provide for the enforcement of, statutory provisions applicable to the provision of family planning services to minors and other vulnerable populations. Title X itself requires that, “[t]o the extent practicable, entities which receive grants or contracts under this subsection shall encourage familiy [sic] participation in projects under this subsection.” Omnibus Budget Reconciliation Act of 1981, Public Law 97-35, sec. 931(b)(1), 95 Stat. 375, 570 (1981); 42 U.S.C. 300(a). A rider in HHS's annual appropriations act adds that “[n]one of the funds appropriated in this Act may be made available to any entity under title X of the PHS Act unless the applicant for the award certifies to the Secretary that it encourages family participation in the decision of minors to seek family planning services.” Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 207, 132 Stat. 348, 736 (2018)

priations act adds that “[n]one of the funds appropriated in this Act may be made available to any entity under title X of the PHS Act unless the applicant for the award certifies to the Secretary that it encourages family participation in the decision of minors to seek family planning services.” Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 207, 132 Stat. 348, 736 (2018). It also requires an applicant to certify that it “provides counseling to minors on how to resist attempts to coerce minors into engaging in sexual activities.” Id. And another provision in the annual HHS appropriations act states 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.” Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 208, 132 Stat. 348, 736 (2018).

Finally, the proposed regulations would require compliance with, and provide for the enforcement of, several additional laws that protect the conscience rights of individuals and entities who decline to perform, participate in, or refer for abortions, including the Church Amendments (42 U.S.C. 300a-7), the Coats-Snowe Amendment (section 245 of the Public Health Service Act, 42 U.S.C. 238n), and the Weldon Amendment, see, e.g., Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 507(d), 132 Stat. 348, 764 (2018); Consolidated Appropriations Act, 2017, Public Law 115-31, Div. H, sec. 507(d), 131 Stat. 135, 521 (2017) (collectively, the “conscience statutes”). The Church Amendments, for example, prohibit grantees from discriminating in the employment of, or the extension of staff privileges to, any health care professional because she refused, because of her religious beliefs or moral convictions, to perform or assist in the performance of any lawful sterilization or abortion procedures

31 Stat. 135, 521 (2017) (collectively, the “conscience statutes”). The Church Amendments, for example, prohibit grantees from discriminating in the employment of, or the extension of staff privileges to, any health care professional because she refused, because of her religious beliefs or moral convictions, to perform or assist in the performance of any lawful sterilization or abortion procedures. They also prohibit individuals from being required to perform or assist in the performance of any health service program or research activity funded in whole or in part under a program administered by the Secretary contrary to her religious beliefs or moral convictions. 43 The Coats-Snowe Amendment prohibits the Federal government and any State or local government that receives Federal financial assistance from discriminating against any health care entity (including individual providers) on the basis that the entity refuses to, among other things, (1) receive training in induced abortion; (2) require or provide abortion training; (3) perform abortions; (4) provide referral for such abortions or abortion training; or (5) make arrangements for any such activities. See 42 U.S.C. 238n(a). And the Weldon Amendment prohibits funds made available in HHS's annual appropriations act from being “made available to a Federal agency or program, or to a State or local government, if such agency, program, or government subjects any institutional or individual health care entity to discrimination on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortions.” It provides that “ `health care entity' includes an individual physician or other health care professional . . . .” See, e.g., Consolidated Appropriations Act, 2018,

43 In addition, section 300a-7(c)(1) provides that “[n]o entity which receives a grant, contract, loan, or loan guarantee under the [Act] . .

alth care entity does not provide, pay for, provide coverage of, or refer for abortions.” It provides that “ `health care entity' includes an individual physician or other health care professional . . . .” See, e.g., Consolidated Appropriations Act, 2018,

43 In addition, section 300a-7(c)(1) provides that “[n]o entity which receives a grant, contract, loan, or loan guarantee under the [Act] . . . may (A) discriminate in the employment, promotion, or termination of employment of any physician or other health care personnel, or (B) . . . in the extension of staff or other privileges to any physician or other health care personnel . . . because he refused to perform or assist in the performance of . . . [an] abortion” on the grounds that doing so “would be contrary to his religious beliefs or moral convictions . . . .” 42 U.S.C. 300a-7(c)(1). Section 300a-7(c)(2) provides that “[n]o entity which receives . . . a grant or contract for biomedical or behavioral research under any program administered by [HHS]” may discriminate in the employment of or the extension of staff privileges to any health care professional “because he refused to perform or assist in the performance of” “any lawful health service” based on religious belief or moral conviction. 42 U.S.C. 300a-7(c)(2). Section 300a-7(d) provides that “[n]o individual [may] be required to perform or assist in the performance of any part of a health service program . . . funded in whole or in part under a program administered by the Secretary of Health and Human Services” if doing so “would be contrary to his religious beliefs or moral convictions.” 42 U.S.C. 300a-7(d). Section 300a-7(e) prohibits any entity that receives funding under the PHS Act from denying admission to, or otherwise discriminating against, “any applicant (including for internships and residencies) for training or study because of the applicant's reluctance . . . to counsel, suggest, recommend, assist, or in any way participate in the performance of abortions . .

ctions.” 42 U.S.C. 300a-7(d). Section 300a-7(e) prohibits any entity that receives funding under the PHS Act from denying admission to, or otherwise discriminating against, “any applicant (including for internships and residencies) for training or study because of the applicant's reluctance . . . to counsel, suggest, recommend, assist, or in any way participate in the performance of abortions . . . contrary to or consistent with the applicant's religious beliefs or moral convictions.” 42 U.S.C. 300a-7(e). In addition, section 300a-7(b) provides in part that “[t]he receipt of any grant, contract, loan, or loan guarantee under the [PHS Act] . . . by any individual or entity does not authorize any court or any public official or other public authority to require” (1) the individual to perform or assist in an abortion if it would be contrary to his/her religious beliefs or moral convictions; or (2) the entity to make its facilities available for abortions, if the performance of abortions in the facilities is prohibited by the entity on the basis of religious beliefs or moral convictions, or provide personnel for the performance of abortions if it would be contrary to the religious beliefs or moral convictions of such personnel. 42 U.S.C. 300a-7(b).

IV. Provisions of the Proposed Rule

A. Section 59.1 To what programs do these regulations apply?

gious beliefs or moral convictions of such personnel. 42 U.S.C. 300a-7(b).

IV. Provisions of the Proposed Rule

A. Section 59.1 To what programs do these regulations apply?

Under federal law, including Title X, subrecipients of federal funds who agree to assist a primary grantee in implementing the grant project are required to comply with the same requirements that are imposed on the grantee. In order to ensure clarity and full implementation of the requirements of Title X and its implementing regulations, the Secretary proposes to amend § 59.1 to make it clear that these regulatory requirements apply equally to subrecipients and to grantees, that grantees are responsible for requiring that their subrecipients (and the subrecipients of such subrecipients) agree to comply with such requirements, and that grantees are responsible for ensuring that their subrecipients so comply.

Title X authorizes the Secretary to not only award grants but also enter into contracts to establish and operate voluntary family planning projects. 42 U.S.C. 300(a). Although contracts are used for Title X training, the Department is not aware of a history of establishing or operating Title X family planning projects by use of contracts instead of grants. Nevertheless, because the use of contracts to establish and operate family planning projects is explicitly authorized in the statute, the Department believes that the regulations should state that the substantive requirements for Title X family planning projects apply to projects whether they are established by grants or contracts. Therefore these rules propose to specify in § 59.1 that, except for §§ 59.3, 59.4, 59.8, and 59.10, the regulations of this subpart would also be applicable to the execution of contracts under Title X to assist in the establishment and operation of voluntary family planning projects

irements for Title X family planning projects apply to projects whether they are established by grants or contracts. Therefore these rules propose to specify in § 59.1 that, except for §§ 59.3, 59.4, 59.8, and 59.10, the regulations of this subpart would also be applicable to the execution of contracts under Title X to assist in the establishment and operation of voluntary family planning projects. Applicable regulations would be applied in accordance with the statutes, procedures, and regulations that apply to the execution of a Federal contract, as distinct from a grant. Section 59.1 would specify that the use of the terms “grant,” “award,” “grantee,” and “subrecipient” in applicable regulations of this subpart would apply similarly to contracts, contractors and subcontractors, and the use of the term “project” or “program” would also apply to a project or program established by use of a contract. The Departments would specify that §§ 59.3, 59.4, 59.8, and 59.10 would not apply to contracts, because those sections generally describe processes specifically applicable to grants and grant applications, as distinct from the substantive requirements of the other sections of this subpart. Because of the lack of a history of using contracts to establish or operate Title X projects, and because Title X funds used for a contract would offset funds used for a grant, the Department does not believe that specifying that these regulations also generally apply to Title X contracts would affect the regulatory or economic impact of these proposed rules. The Department invites comment on the applicability of these regulations to contracts for the provision of family planning services under Title X.

B. Section 59.2 Definitions

e regulations to contracts for the provision of family planning services under Title X.

B. Section 59.2 Definitions

The current Title X regulations include a limited number of definitions that are very general in scope including “Act,” “family,” “low-income family,” “nonprofit,” “Secretary,” and “state.” Important terms, such as “family planning,” “grantee,” and “subrecipient,” are not defined. The Department believes that, as a result of these omissions, the Title X regulations fail to provide sufficient clarity for prospective grantees and subrecipients, current grantees and subrecipients, and the general public. To ensure greater clarity and accountability in the use of Title X funds, the Secretary proposes the addition of four new definitions to the Title X regulations, 42 CFR 59.2:

• Family Planning • Grantee • Program or Project • Subrecipient Under the proposed regulations, “family planning” would be defined as the voluntary process of identifying goals and developing a plan for the number and spacing of children and the means by which those goals may be achieved. These means include a broad range of acceptable and effective choices, which may range from choosing not to have sex to the use of other family planning methods and services to limit or enhance the likelihood of conception (including contraceptive methods, and natural family planning or other fertility awareness-based methods), and the management of infertility (including adoption). Family planning services include preconceptional counseling, education, and general reproductive and fertility health care to improve maternal and infant outcomes, and the health of women, men, and adolescents who seek family planning services. Family planning and family planning services are never coercive and are strictly voluntary. Family planning does not include post-conception care (including obstetric or prenatal care) or abortion as a method of family planning. Family planning, as supported under this subpart, should reduce the incidence of abortion

and the health of women, men, and adolescents who seek family planning services. Family planning and family planning services are never coercive and are strictly voluntary. Family planning does not include post-conception care (including obstetric or prenatal care) or abortion as a method of family planning. Family planning, as supported under this subpart, should reduce the incidence of abortion.

The Department believes that this proposed definition, which largely tracks the definition of “family planning” in the 1988 Regulations, would provide greater clarity to grantees and subrecipients as to the type of activities that can be provided by projects funded under Title X. It is clear that Congress intended the term “family planning” to be broader in scope than simply contraception; natural family planning and infertility services are included as mandatory services explicitly enumerated in section 1001(a). Physical examinations, breast and cervical cancer screenings, sexually transmitted disease (STD) and human immunodeficiency virus (HIV) testing, and pregnancy testing and counseling would continue to be authorized by this definition under the rubric of “general reproductive and fertility health care.” The proposed definition includes concepts from the 1988 rule identifying family planning as a process of establishing objectives for the number and spacing of children and the means of achieving those objectives. The proposed definition elaborates on “objectives” by specifying they involve both goals and plans, as inherent in the term family “planning.” The definition specifies that the process is “voluntary,” “strictly voluntary,” and “never coercive,” consistent with the statutory requirement that Title X apply only to “voluntary” family planning. The definition specifies that family planning includes management of infertility (including adoption). Both this definition and the 1988 definition include general reproductive health care

“planning.” The definition specifies that the process is “voluntary,” “strictly voluntary,” and “never coercive,” consistent with the statutory requirement that Title X apply only to “voluntary” family planning. The definition specifies that family planning includes management of infertility (including adoption). Both this definition and the 1988 definition include general reproductive health care. 44 The 1988 definition elaborated that it included diagnosis and treatment of infections which threaten reproductive capability. This proposed definition would include that aspect of reproductive health care, as well as the goal of improving maternal and infant

44 The Department is aware that, in the international context, the term “reproductive health care” is often used to encompass abortion and related services. Given the long-standing prohibition on the use of Title X funds for programs/projects where abortion is a method of family planning and the focus of the Title X program on pre-conception care, the Department does not use the term in such a manner; in the Title X context, “reproductive health” or “reproductive health care” does not encompass abortion or abortion-related services.

The other newly proposed definitions are designed to provide greater clarity concerning which entities are subject to the provisions of Title X.

The Department proposes that “project” or “program” be defined as a plan or sequence of activities that fulfills the requirements elaborated in a Title X funding announcement and may be comprised of, and implemented by a single grantee or subrecipient, or a group of partnering providers who, under a grantee or subrecipient, deliver comprehensive family planning services that satisfy the requirements of the grant within a service area. These proposed definitions are consistent with current Title X program practices

quirements elaborated in a Title X funding announcement and may be comprised of, and implemented by a single grantee or subrecipient, or a group of partnering providers who, under a grantee or subrecipient, deliver comprehensive family planning services that satisfy the requirements of the grant within a service area. These proposed definitions are consistent with current Title X program practices. 45

45 See, e.g., “Definitions” section of the “Program Requirements for Title X Funded Family Planning Projects,” Version 1.0 (April 2014), https://www.hhs.gov/opa/sites/default/files/ogc-cleared-final-april.pdf.

The Department proposes definitions of “grantee” and “subrecipient” because confusion surrounds their meanings. In this proposed rule, “grantee” would mean the entity that receives Federal financial assistance through a grant and assumes legal and financial responsibility and accountability for the awarded funds and for the performance of the activities approved for funding and for making the required reports to OPA.

A clear definition of “subrecipient” is necessary to ensure program integrity related to both financial and programmatic requirements. Title X service sites ( i.e., clinics) that provide Title X services directly to individuals may receive Title X grant monies from the grantee (or another subrecipient) as a secondarily named provider or as an agency that provides services, but may not be specifically named within the grant application. There is a need for transparency that currently does not exist. The Department does not have an accurate understanding of any grantee's subrecipients, of what role each subrecipient plays in the overall function of the Title X project, or of the extent to which Title X funding supports the efforts of the subrecipient. Additional transparency would help to ensure accountability for, and wise use of, taxpayers' money

r transparency that currently does not exist. The Department does not have an accurate understanding of any grantee's subrecipients, of what role each subrecipient plays in the overall function of the Title X project, or of the extent to which Title X funding supports the efforts of the subrecipient. Additional transparency would help to ensure accountability for, and wise use of, taxpayers' money. Current Title X regulations, however, do not require grantees to submit information to the government about their subrecipients, referral agencies, or other partners to whom Title X funds may flow. This lack of information is a barrier to OPA's oversight of the activities of its program and project subrecipients and, ultimately, to governmental accountability for those funds.

Therefore, the Department proposes to define “subrecipient” as any entity that provides family planning services with Title X funds under a written agreement with a grantee or another subrecipient. These subrecipients have entered into binding agreements or other financial relationships with Title X grantees to provide Title X services in a given State or community. A “[s]ubrecipient” may also be referred to as a “delegate” or “contract agency.” These entities receive Title X funds to provide Title X services, and are subject to the Title X statute and regulations. This proposed definition would help clarify the entities that receive Title X monies, how they use these funds, and how their services comply with the purpose of the Title X program. In addition, the definition would elucidate the relationship between the grantees and their subrecipients, and would convey, along with the proposed changes to § 59.1, that grantees are responsible for ensuring that their subrecipients (and the subrecipients of such subrecipients) comply with all statutory and regulatory requirements

w their services comply with the purpose of the Title X program. In addition, the definition would elucidate the relationship between the grantees and their subrecipients, and would convey, along with the proposed changes to § 59.1, that grantees are responsible for ensuring that their subrecipients (and the subrecipients of such subrecipients) comply with all statutory and regulatory requirements.

To the extent an entity receives Title X funds from a grantee or a subrecipient, it receives funds to provide Title X services, and is thus a subrecipient subject to the Title X statute and regulations. By contrast, some referral agencies do not receive funds from the Title X grant program, but may nevertheless provide information, counseling, or services to a Title X client. A referral agency or individual is a person or entity which is a specialist in a certain field of service and to whom the Title X project refers patients for additional services not available at the Title X clinic site, or not adequately available at the site, to serve the immediate needs of the patient. For example, an individual may visit the Title X clinic for contraceptive services, but in the course of conversation, it may be revealed that the individual wants to end a current intimate and unhealthy relationship. In this case, a referral could then be made to an entity that has expertise in relationship counseling beyond what is available in this Title X clinic. In this and similar cases, the referral agencies would not be considered subrecipients, since they do not receive Title X funds. But because such services are an extension of the overall Title X service provision, in certain cases referral agencies participate in, and receive intrinsic non-monetary benefits as a result of, a formal or informal partnership with a Title X project

his Title X clinic. In this and similar cases, the referral agencies would not be considered subrecipients, since they do not receive Title X funds. But because such services are an extension of the overall Title X service provision, in certain cases referral agencies participate in, and receive intrinsic non-monetary benefits as a result of, a formal or informal partnership with a Title X project. Accordingly, we seek comment on whether such a referral agency should be subject to the same reporting requirements as a grantee or subrecipient—by means of requiring grantees and subrecipients to use referral agencies only if they require the referral agencies to submit the required information. This could apply if the referral agency:

• Has a written agreement with the grantee or another subrecipient;

• specifically uses its inclusion in the Title X project to expand its influence in the community; or

• conducts its services, activities, or communications in such a way that its participation in the Title X project is central, or very important, to its existence.

Finally, this proposed rule would amend the definition of “low income family” to include women who are unable to obtain certain family planning services under their employer-sponsored health insurance policies due to their employers' religious beliefs or moral convictions. This would preserve conscience protections for entities and individuals whose health plans are subject to a mandate of contraceptive coverage through guidance issued pursuant to the Patient Protection and Affordable Care Act, while providing free or low-cost family planning services for such women at risk of unintended pregnancy or who otherwise desire comprehensive, holistic, family planning services.

Act, while providing free or low-cost family planning services for such women at risk of unintended pregnancy or who otherwise desire comprehensive, holistic, family planning services.

The proposed definition of “low income family” would maintain the ability of a Title X project to determine whether unemancipated minors who desire confidential services are low income based on their own resources. However, to ensure compliance with the statutory requirement that Title X projects encourage family participation in the decision of minors to seek family planning services, Title X clinics would be required to document in the minor's medical records the specific actions taken with respect to each minor to encourage such family participation. Documentation of such encouragement would not be required if the Title X clinic documents in the medical record that (1) the minor is suspected to be the victim of child abuse or incest and (2) it has, consistent with and if permitted or required by applicable State or local law, reported the situation to the relevant authorities.

C. Section 59.3 Who is eligible to apply for a family planning services grant or to participate as a subrecipient as part of a family planning project?

Consistent with the requirements of the Joint Resolution of Disapproval,

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

cipient as part of a family planning project?

Consistent with the requirements of the Joint Resolution of Disapproval,

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

Section 1001(a) of the Title X statute requires Title X projects to “offer a broad range of acceptable and effective family planning methods and services (including natural family planning methods . . .).” The current regulations state, somewhat differently, that projects must “[p]rovide a broad range of acceptable and effective medically approved family planning methods (including natural family planning methods) and services (including infertility services and services for adolescents),” and note that “[i]f 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 family planning services.” 42 CFR 59.5(a)(1).

The current regulation, while worded differently than the statute, does not override the statutory requirement that projects offer “a broad range of acceptable and effective family planning methods and services (including natural family planning methods . . .).” 42 U.S.C. 300(a). Although the current regulations require that projects provide, at a minimum, a broad range of “medically approved” family planning methods, they do not preclude the Department from requiring more, namely, as the statute provides, “a broad range of acceptable and effective family planning methods and services (including natural family planning methods . . .).” Moreover, the current regulations do not define “medically approved,” and have not required that a family planning method be regulated, approved, or certified by any particular agency or accreditation body. If a family planning method is, as required by the statute, “acceptable and effective,” it is likely to be approved by at least some medical sources

ing natural family planning methods . . .).” Moreover, the current regulations do not define “medically approved,” and have not required that a family planning method be regulated, approved, or certified by any particular agency or accreditation body. If a family planning method is, as required by the statute, “acceptable and effective,” it is likely to be approved by at least some medical sources. For example, in March 2016, the American College of Obstetricians and Gynecologists (ACOG) launched the “Women's Preventive Services Initiative.” In its “Clinical Recommendations,” ACOG recommended that instruction in fertility awareness-based methods of family planning, and counseling, initiation of use, follow-up care, management, and evaluation of the same, be provided with no cost-sharing in health coverage. 46 The Health Resources and Services Administration (HRSA), a component of HHS, adopted this recommendation on December 20, 2016, and added coverage of fertility awareness based methods of family planning to its women's preventive services guidelines, issued pursuant to Section 2713(a)(4) of the Affordable Care Act (42 U.S.C. 300gg-13(a)(4)). 47 On this basis, fertility awareness-based methods of family planning could be said to be “medically approved.” Medical doctors and professional organizations can differ on which methods of health care they approve, including different methods of family planning. Such differences may be based on differing areas of expertise, or differing views of the health care method.

46 See Women's Preventive Services Initiative, Clinical Recommendations, American College of Obstetricians and Gynecologists, https://www.womenspreventivehealth.org/recommendations/contraception.

47 See HRSA, Women's Preventive Services Guidelines, https://www.hrsa.gov/womens-guidelines-2016/index.html.

Similarly, certain family planning methods or services may not fall under the regulatory jurisdiction or expertise of some government agencies

ical Recommendations, American College of Obstetricians and Gynecologists, https://www.womenspreventivehealth.org/recommendations/contraception.

47 See HRSA, Women's Preventive Services Guidelines, https://www.hrsa.gov/womens-guidelines-2016/index.html.

Similarly, certain family planning methods or services may not fall under the regulatory jurisdiction or expertise of some government agencies. The Food and Drug Administration has regulatory jurisdiction over drugs, biologics, and medical devices. As such, while it has regulatory authority over and approves or clears contraceptive drugs and devices, FDA would not necessarily have regulatory jurisdiction over, or an approval process for, other family planning methods. Some fertility awareness-based methods of family planning might be a drug or device, such as certain fertility awareness kits that are or contain a medical device. 48 Other fertility awareness-based methods of family planning might not be drugs or devices, use drugs or devices, or be sold in conjunction with drugs or devices. Some methods might be merely instructional, or might include the recommendation that certain kinds of drugs or devices be used, without the “method” itself being a drug or device. When HRSA added fertility awareness-based methods of family planning and counseling to its women's preventive services guidelines, it did so even though the guidelines already included all FDA-approved contraceptive and sterilization methods, because the birth control methods FDA has approved or cleared are all drugs and devices. 49 The fact that non-drug and non-device fertility awareness-based methods of family planning are not on FDA's list of approved birth control methods does not mean that such fertility awareness-based methods are not “medically approved,” but rather means that they are not drugs or medical devices, and, thus, not under FDA's jurisdiction and not subject to FDA's approval or clearance

s and devices. 49 The fact that non-drug and non-device fertility awareness-based methods of family planning are not on FDA's list of approved birth control methods does not mean that such fertility awareness-based methods are not “medically approved,” but rather means that they are not drugs or medical devices, and, thus, not under FDA's jurisdiction and not subject to FDA's approval or clearance.

48 See FDA Enforcement History, https://www.fda.gov/iceci/enforcementactions/enforcementstory/enforcementstoryarchive/ucm106947.htm (“Warning Letter Issued for “Fertility Awareness Kit”).

49 See FDA, https://www.fda.gov/ForConsumers/ByAudience/ForWomen/FreePublications/ucm313215.htm.

The Department proposes to revert to the statutory language that Title X projects “offer a broad range of acceptable and effective family planning methods and services.” In so doing, the proposed rule would remove the language specifying that the family planning methods and services offered by a Title X project be “medically approved.” That language does not appear in the statute and may cause confusion about the type of family planning methods or services that a project may or should provide, and the type of approvals (if any) necessary before a Title X project can provide such method or service. The statutory language of “acceptable and effective family methods or services” provides better guidance for the types of methods and services that Congress sought to fund.

The proposed rule would also make it more explicit that the requirement to provide a “broad range” of acceptable and effective family planning methods and services does not require a project to provide every acceptable and effective family planning method or service. The meaning of “broad range” has been the subject of inquiries from grantees and lawmakers at all levels of government, as well as from members of the public, and has resulted in potentially inconsistent interpretations of the “broad range” mandate

effective family planning methods and services does not require a project to provide every acceptable and effective family planning method or service. The meaning of “broad range” has been the subject of inquiries from grantees and lawmakers at all levels of government, as well as from members of the public, and has resulted in potentially inconsistent interpretations of the “broad range” mandate. Some have interpreted the “broad range” requirement of section 1001(a), as well as of 42 CFR 59.5(a)(1), to require that a project provide all forms of family planning approved or cleared by the Food and Drug Administration (FDA). The plain language of the statutory (and regulatory) requirements, however, does not require projects to provide every acceptable and effective family planning

Not every grantee or subrecipient can provide—or should be required to provide—all services. The proposed rule would also make it more explicit that the requirement to provide a “broad range” of acceptable and effective family planning methods and services does not require a project to provide every acceptable and effective family planning method or service. This proposed change reflects the fact that, as the range of available family planning methods has significantly increased over the last few decades, it has become increasingly difficult and expensive for a Title X project to offer all acceptable and effective forms of family planning. Indeed, family planning projects are confronted with a variety of pharmacological, technological, or medical device options to consider in service delivery, with widely varying costs. Staffing limitations, technological capacity, economics (including costs and demand), and conscience concerns may be taken into account when grantees or subrecipients determine which methods they will offer within their scope of services

ng projects are confronted with a variety of pharmacological, technological, or medical device options to consider in service delivery, with widely varying costs. Staffing limitations, technological capacity, economics (including costs and demand), and conscience concerns may be taken into account when grantees or subrecipients determine which methods they will offer within their scope of services. For example, natural family planning (NFP) services (and other fertility-awareness based methods) are a recognized form of family planning services under the statute, but many couples or families seeking these services may prefer specialized, single-method NFP service sites. Other sites serving men may offer only family planning methods relevant to that population. Another site may be a hospital satellite location which is primarily diagnostic in function, although it also offers some on-site family planning services. Such sites are permissible as components of a Title X family planning project, as long as the overall project provides a broad range of acceptable and effective family planning methods and services. In these examples, some participants in the Title X project offer specialized services, but not a broad range of family planning methods and services. However, such limited family planning service offering is permissible as long as the overall Title X project offers a broad range of family planning services, including contraceptives. 50

50 The Department notes that the Title X statute would not permit a Title X project to provide only one (or a limited number of) family planning methods and services.

epartment notes that the Title X statute would not permit a Title X project to provide only one (or a limited number of) family planning methods and services.

Thus, under the proposed rule, no Title X project would be required to provide every acceptable and effective family planning method or service, but all Title X projects would be required to provide a broad range of family planning methods. Family planning methods which are permitted with Title X funds include (but are not limited to): Male condom, spermicide, cervical cap, fertility awareness based methods, female condom, diaphragm, vaginal contraceptive ring, IUD, oral contraceptives, shot/injection, implantable rod, vasectomy, and sexual risk avoidance (or avoiding sex). Under the proposed rule, any organization that desires to provide only a single method, or limited number of methods of family planning, may participate, as long as the Title X project as a whole offers a broad range of family planning methods and services. Title X specifically identifies natural family planning, infertility services, and services for adolescents, as voluntary family planning services that Title X projects “shall offer,” 42 U.S.C. 300(a), making these family planning methods and services mandatory for each Title X project (although, as discussed elsewhere herein, it is not required that each provider within a project offer each method). That is, included in the broad range of acceptable and effective family planning methods and services that each Title X project must offer are natural family planning methods, infertility services, and services for adolescents.

ces for adolescents.

The proposed rule would also remove the requirement that past grantees be consulted for new services or projects in their locale as set forth in paragraph (a)(10)(i) of the current regulation. We believe that removing this requirement would encourage a broader range of applicants and permit innovative approaches that may not have been envisioned or supported by past grantees. While communication and coordination is often beneficial and encouraged, removing the requirement for consultation is intended to have the effect of loosening the status quo for service provision in a community in favor of a broader reach in order to previously underserved populations.

The proposed rule would make it clear that, as contemplated by the statute, family planning is not limited to, or synonymous with, access to various methods of contraception, but includes a broader understanding of family planning methods and services. Family planning services should fit the family planning needs of the individual, and/or couple (if applicable). And in order to promote a holistic approach to family planning and reproductive health, the proposed rule would inform Title X service providers that they should offer either comprehensive primary health services onsite or have a robust referral linkage with primary health providers who are in physical proximity to the Title X site. This provision decreases the overall cost and transportation challenges related to access for vital health care services that may be discovered as a result of routine family planning screening and consultation

that they should offer either comprehensive primary health services onsite or have a robust referral linkage with primary health providers who are in physical proximity to the Title X site. This provision decreases the overall cost and transportation challenges related to access for vital health care services that may be discovered as a result of routine family planning screening and consultation. Title X service providers should ensure that they have a broad range of partners and diverse subrecipients in order to make it easier for all clients, particularly low income clients, to access necessary medical services and related educational and counseling services, as stipulated by the statute and as necessary to ensure that screening, diagnosis, and treatment can be provided within close proximity of the clinic, and to ensure that the most needy have access to care. 51

51 A 2013 Child Trends Research Brief, “The Health of Women Who Receive Title X supported family Planning Services” found that 60% of women receiving care at Title X clinics report that the clinic is their primary source for health care, yet many fear they cannot address other health concerns with their family planning provider, making the need for a linkage to comprehensive primary care providers essential for women's health. The report also found that women who receive care at Title X clinics generally have worse health than women who receive services elsewhere, and that of such women, (1) over 25% report at least 3 health concerns; and (2) one-third are obese, with an additional 29% being overweight. Since Title X family planning services are generally limited to preconception services, it is important that Title X sites assist clients to achieve optimal preconception health. A large number of women experience unintended pregnancies, making the inclusion of preconception health screenings in the continuum of family planning care all the more important for all clients (male and female), not only those seeking pregnancy

ning services are generally limited to preconception services, it is important that Title X sites assist clients to achieve optimal preconception health. A large number of women experience unintended pregnancies, making the inclusion of preconception health screenings in the continuum of family planning care all the more important for all clients (male and female), not only those seeking pregnancy. Preconception health care is important because pregnancy may stress and affect extant health conditions; linkages to comprehensive primary health care may be critical to ensuring that pregnancy does not negatively impact such conditions. In addition, the greatest risks affecting the health of a baby occur early in a pregnancy—often before a woman realizes she is pregnant—such that helping women achieve optimal preconception health is important to ensure healthy pregnancies (as well as healthy babies) should conception occur.

To expand transparency surrounding Title X services, the proposed rule would require applicants to provide the following within their applications (to the extent secured at the time of application) and, if funded, in required reports, and in response to performance measures, wherever practicable:

• Names and locations of subrecipients, referral individuals and agencies, as well as services provided and to be provided by those entities;

• Detailed descriptions of all partnerships with such entities, including the extent of any

dividuals and agencies, as well as services provided and to be provided by those entities;

• Detailed descriptions of all partnerships with such entities, including the extent of any

In addition, in order to promote compliance with a requirement present in both Title X itself and the Title X appropriations provisions, 52 the proposed rule would require Title X service providers to encourage family participation in the decision of minors to seek family planning services and to document, in the records maintained with respect to each minor, the specific actions taken to encourage such family participation (or the specific reason why such family participation was not encouraged). 53

52 See 42 U.S.C. 300(a); Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, sec. 207, 132 Stat. at 736.

53 Of course, as noted above, the fact that child abuse, child molestation, incest, or the like is suspected and has been reported to the appropriate authorities, consistent with State or local reporting or notification laws, would constitute such reason.

E. Section 59.7 Criteria for Selection of Grantees

As discussed above, the Department is focused on achieving better integration of primary and preventive care among a diverse group of applicants, using review criteria as a meaningful instrument to assess the quality of the applicant and the application. The current regulations give HHS flexibility in selecting grantees and determining awards, but could better ensure that review criteria are geared to achieving the selection of grantees that can best achieve the goals and purposes of the Title X program. Therefore, through the proposed rule, we would seek to achieve a two-fold goal:

• Update application review criteria to better achieve the statutory requirements and goals of Title X

ility in selecting grantees and determining awards, but could better ensure that review criteria are geared to achieving the selection of grantees that can best achieve the goals and purposes of the Title X program. Therefore, through the proposed rule, we would seek to achieve a two-fold goal:

• Update application review criteria to better achieve the statutory requirements and goals of Title X.

• Increase competition and rigor among applicants, encouraging broader and more diverse applicants, and better ensuring quality applicants will be selected.

The Department desires to award grants for the establishment and operation of those Title X projects that would best promote the purposes of Title X and meet the statutory requirements imposed on Title X projects.

We propose revising the current application review criteria at § 59.7 through this rulemaking process to update and expand criteria for selection of Title X grantees as follows. Any grant applications that do not clearly address how the proposal will satisfy the requirements of this regulation would not proceed to the competitive review process, but would be deemed ineligible for funding. The Department would explicitly summarize each provision of the regulation (or include the entire regulation) within the Funding Announcement, and would require each applicant to describe their affirmative compliance with each provision. If the proposal is deemed compliant with the regulation, then applicants would be subject to criteria for selection within the competitive grant review process, including:

ment would explicitly summarize each provision of the regulation (or include the entire regulation) within the Funding Announcement, and would require each applicant to describe their affirmative compliance with each provision. If the proposal is deemed compliant with the regulation, then applicants would be subject to criteria for selection within the competitive grant review process, including:

(1) The degree to which the applicant's project plan adheres to the Title X statutory purpose and goals for the “establishment and operation of voluntary family planning projects which shall offer a broad range of acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services for adolescents,” (PHS Act Sec. 1001(a), 42 U.S.C. 300(a)), which meet all of the statutory and regulatory requirements and restrictions, and where “none of the funds . . . shall be used in programs where abortion is a method of family planning.” (PHS Act Sec. 1008, 42 U.S.C. 300a-6.)

(2) The degree to which “the relative need of the applicant” (PHS Act Sec 1001(b), 42 U.S.C. 300(b)) is demonstrated in the proposal and the applicant shows capacity to “make rapid and effective use” (PHS Act Sec. 1001(b), 42 U.S.C. 300(b)) of grant funds, including and especially among a broad range of partners and diverse subrecipients and referral individual and organizations, and among non-traditional Title X partnering organizations.

e subrecipients and referral individual and organizations, and among non-traditional Title X partnering organizations.

These proposed criteria would advance compliance with the text and purpose of Title X by seeking grantees to better serve the targeted population with services that are needed, focused on family planning in the context of holistic health in both the short and long term.

The Department seeks public comment as to whether additional regulatory application review criteria may be necessary or advisable to reflect the text and purpose of the statutory provisions applicable to Title X, in particular section 1008; to protect the rights of individuals and entities who decline to participate in abortion-related activities; or to ensure that all services funded through Title X offer optimal health benefits to clients of all ages. The Department also seeks public comment as to whether the protections and services funded through Title X are adequately implemented and clearly understood throughout the Title X program, in order to alleviate the current confusion, and avoid future confusion, among clients and the general public.

F. Section 59.11 Confidentiality

throughout the Title X program, in order to alleviate the current confusion, and avoid future confusion, among clients and the general public.

F. Section 59.11 Confidentiality

As discussed above, Title X grantees and subrecipients are required to comply with all State and local laws requiring notification or reporting of child abuse, child molestation, sexual abuse, rape, incest, and the like. Section 59.11 currently provides that personal information may not be disclosed absent consent by the individual, except to provide treatment, or as required by law, “with appropriate safeguards for confidentiality.” To ensure that Title X grantees and subrecipients comply with applicable reporting requirements, the proposed rule would clarify that concerns about confidentiality of information may not be used as a rationale for noncompliance with such reporting laws.

G. Section 59.13 Standards of Compliance With Prohibition on Abortion

Current Title X regulations at 42 CFR 59.5(a)(5) state that “[e]ach project supported under this part must . . . not provide abortion as a method of family planning.” However, the Department has determined that such regulations do not provide sufficient guidance to ensure that Title X projects comply with section 1008 and do not encourage or promote abortion as a method of family planning. Proposed § 59.13 would accordingly require that programs seeking Title X funding provide assurance satisfactory to the Secretary that, as Title X grantees, they do not provide abortions and do not include abortion as a method of family planning.

H. Section 59.14 Prohibition on Referral for Abortion

Proposed § 59.14 would expressly prohibit Title X projects from performing, promoting, referring for, or supporting, abortion as a method of family planning

king Title X funding provide assurance satisfactory to the Secretary that, as Title X grantees, they do not provide abortions and do not include abortion as a method of family planning.

H. Section 59.14 Prohibition on Referral for Abortion

Proposed § 59.14 would expressly prohibit Title X projects from performing, promoting, referring for, or supporting, abortion as a method of family planning. 54 As discussed above, the Department believes that the current requirement under 42 CFR 59.5(a)(5)(ii) that a project provide abortion referrals to pregnant women upon request is inconsistent with section 1008, premised on an erroneous notion that the statute is neutral on the question whether Title X funds may be used to encourage or promote abortion as a method of family planning, and violative of Federal health care conscience statutes. The proposed provision would better implement section 1008 and better align the regulations implementing Title X with those Federal health care conscience statutes. It would also promote grantee diversity by expanding the number of qualified entities that would be willing and able to apply to provide Title X services, since potential grantees and subrecipients that refuse to provide abortion referrals may have been ineligible or discouraged from applying for Title X grants or seeking to provide family planning services under a Title X project by the requirements of the current regulations.

54 In the case of rape and/or incest, it would not be considered a violation of the proposed prohibition on referral for abortion as a method of family planning if a patient is provided a referral to a licensed, qualified, comprehensive health service provider who also provides abortion, provided that the Title X provider has complied with all State and/or local laws requiring reporting to, or notification of, law enforcement or other authorities and such reporting or notification is documented in the patient's record

ortion as a method of family planning if a patient is provided a referral to a licensed, qualified, comprehensive health service provider who also provides abortion, provided that the Title X provider has complied with all State and/or local laws requiring reporting to, or notification of, law enforcement or other authorities and such reporting or notification is documented in the patient's record.

Proposed § 59.14 would prohibit referral for abortion as a method of family planning or any other affirmative action to secure such an abortion in a Title X project. Under the proposed provision, referrals could not be used as an indirect means to encourage or promote abortion. In addition, Title X projects do not themselves provide post-conception care. Thus, proposed § 59.14 would require that pregnant women be referred outside of the Title X project for prenatal care and other related medical and social services, as well as for other services relating to pregnancy after pregnancy is confirmed. In no case would the proposed provision permit a Title X-funded family planning program to make a referral for, or determine the appropriateness of, abortion as a method of family planning. As discussed above, a doctor, though not required to do so, would be permitted to provide nondirective counseling on abortion. 55 Such nondirective counseling would not be considered encouragement, promotion, or advocacy of abortion as a method of family planning, as prohibited under section 59.16 of this proposed rule. Moreover, a doctor would also be permitted to provide a list of licensed, qualified, comprehensive health service providers, some (but not all) of which provide abortion in addition to comprehensive prenatal care. Providing such a list would be permitted only in cases where a program client who is currently pregnant clearly states that she has already decided to have an abortion

his proposed rule. Moreover, a doctor would also be permitted to provide a list of licensed, qualified, comprehensive health service providers, some (but not all) of which provide abortion in addition to comprehensive prenatal care. Providing such a list would be permitted only in cases where a program client who is currently pregnant clearly states that she has already decided to have an abortion. 56 No participant in the Title X program may promote or support abortion as an acceptable mechanism of family planning through that Title X program. Thus, all other patients would be provided a list of licensed, qualified, comprehensive health service providers (including providers of prenatal care) who do not provide abortion as a part of their services, along with referrals for prenatal care and social services.

55 That counseling on abortion be nondirective is required by the appropriations law applicable to Title X. See Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, Title II, 132 Stat. at 716-17 (“all pregnancy counseling shall be nondirective”).

56 The list may not identify in any way the providers that perform abortions in addition to comprehensive prenatal care.

It is important to recognize that proposed § 59.14 would not prohibit Title X projects from providing the factual information necessary to assess risks of a particular family planning or contraceptive method as set out in the patient package inserts. Neither would proposed § 59.5, or § 59.14 preclude a health care professional from disclosing to a woman any physical findings the professional has made regarding the woman's condition; communicating an assessment of the urgency of the need for treatment; or ensuring that the woman is referred to the appropriate specialist for treatment of the condition, including emergent conditions, with adequate follow-up provided

ed § 59.5, or § 59.14 preclude a health care professional from disclosing to a woman any physical findings the professional has made regardin

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