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Institute of Medicine (US) Committee on a Comprehensive Review of the HHS Office of Family Planning Title X Program; Stith Butler A, Wright Clayton E, editors. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington (DC): National Academies Press (US); 2009.
Institute of Medicine (US) Committee on a Comprehensive Review of the HHS Office of Family Planning Title X Program; Stith Butler A, Wright Clayton E, editors.
Washington (DC): National Academies Press (US); 2009.United States Department of Health and Human Services
Office of Public Health and Science
Office of Population Affairs
Office of Family Planning
4350 East West Highway, Suite 200
Bethesda, Maryland 20814
January 2001
This document, Program Guidelines for Project Grants for Family Planning Services (Guidelines), has been developed by the Office of Population Affairs (OPA), U.S. Department of Health and Human Services (DHHS), to assist current and prospective grantees in understanding and utilizing the family planning services grants program authorized by Title X of the Public Health Service Act, 42 U.S.C. 300, et seq. The Office of Population Affairs also provides more detailed guidance, updated clinical information and clarification of specific program issues in the form of periodic Program Instructions to the Regional Offices.
This document is organized into two parts. Part I (sections 1-6) covers project management and administration, including the grant application and award process. Part II (sections 7-11) covers client services and clinic management.
Reference is made throughout the document to specific sections of the Title X law and implementing regulations, which are contained in Attachments A and B, respectively. (Reference to specific sections of the regulations will appear in brackets, e.g., [45 CFR Part 74, Subpart C].) Federal sterilization regulations are contained in Attachment C. The DHHS regional offices are listed in Attachment D. Selected other materials that provide additional guidance in specific areas are classified as Resource Documents.
Throughout this document, the word “must” indicates mandatory program policy. “Should” indicates recommended program policy relating to components of family planning and project management that the project is urged to utilize in order to fulfill the intent of Title X. The words “can” and “may” indicate suggestions for consideration by individual projects.
The "grantee” is the entity that receives a Federal grant and assumes legal and financial responsibility and accountability for the awarded funds and for the performance of the activities approved for funding. The “project” consists of those activities described in the grant application and supported under the approved budget. “Delegate/contract agencies” are those entities that provide family planning services with Title X funds under a negotiated, written agreement with a grantee. “Service sites” are those locations where services actually are provided by the grantee or delegate/contract agency.
To enable persons who want to obtain family planning care to have access to such services, Congress enacted the Family Planning Services and Population Research Act of 1970 (Public Law 91-572), which added Title X, “Population Research and Voluntary Family Planning Programs" to the Public Health Service Act. Section 1001 of the Act (as amended) authorizes grants "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)” (see Attachment A). The mission of Title X is to provide individuals the information and means to exercise personal choice in determining the number and spacing of their children.
The regulations governing Title X [42 CFR Part 59, Subpart A] set out the requirements of the Secretary, Department of Health and Human Services, for the provision of family planning services funded under Title X and implement the statute as authorized under Section 1001 of the Public Health Service Act. Prospective applicants and grantees should refer to the regulations (see Attachment B). This document, Program Guidelines for Project Grants for Family Planning Services, interprets the law and regulations in operational terms and provides a general orientation to the Federal perspective on family planning.
Any public or nonprofit private entity located in a state (which, by definition, includes the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the U.S. Virgin Islands, American Samoa, the U.S. Outlying Islands [Midway, Wake, et al.], the Marshall Islands, the Federated States of Micronesia and the Republic of Palau) is eligible to apply for a Title X family planning services project grant [59.2, 59.3].
To promote the purposes of Section 1001 of the Act in the most cost effective and efficient manner, grants will be made to public and non-profit private entities to foster projects most responsive to local needs. A non-profit private agency, institution, or organization must furnish evidence of its non-profit status in accordance with instructions accompanying the project grant application form. Under the law, grants cannot be made to entities that propose to offer only a single method or an unduly limited number of family planning methods. A facility or entity offering a single method can receive assistance under Title X by participating as a delegate/contract agency in an approvable project that offers a broad range of acceptable and effective medically approved family planning methods and services [59.5(a)(1)].
An assessment of the need for family planning services must be conducted prior to applying for a competitive grant award. The needs assessment documents the need for family planning services for persons in the service area and should include:
Description of the geographic area including a discussion of potential geographic, topographic, and other related barriers to service;
Demographic description of the service area including objective data pertaining to individuals in need of family planning services, maternal and infant morbidity/mortality rates, birth rates and rates of unintended pregnancies by age groups, poverty status of the populations to be served, cultural and linguistic barriers to services, etc.;
Description of existing services and need for additional family planning services to meet community/cultural needs;
Need indicators that include rates of STDs and HIV prevalence (including perinatal infection rates) in the grantee area;
Identification and descriptions of linkages with other resources related to reproductive health; and Identification and discussion of high priority populations and target areas.Grantees should perform periodic reassessment of service needs. Competitive grant applications must include a full and updated needs assessment.
The Department of Health and Human Services’ Office of Population Affairs administers the Title X Family Planning Program through the DHHS Regional Offices. An annual announcement of the availability of Title X service grant funds sets forth specific application requirements and evaluation criteria. Applications must be submitted to the Office of Grants Management for Family Planning Services on the form required by the Department. The application forms are available from the Office of Grants Management for Family Planning Services. Assistance regarding programmatic aspects of proposal preparation is available from the Regional Office. For assistance with administrative and budgeting aspects of proposal preparation, contact the Office of Grants Management for Family Planning Services.
Unless otherwise instructed, applicants are to respond to the standard instructions contained in the application kit and to the PHS supplemental instructions. An application must contain:
a needs assessmenta narrative description of the project and the manner in which the applicant intends to conduct it in order to carry out the requirements of the law and regulations;
a budget that includes an estimate of project income and costs, with justification for the amount of grant funds requested [59.4(c)(2)] and which is consistent with the terms of Section 1006 of the Act, as implemented by regulation [59.7(b)];
a description of the standards and qualifications that will be required for all personnel and facilities to be used by the project;
project objectives that are specific, realistic, and measurable; and other pertinent information as required [59.4(c)(4)].The application must address all points contained in section 59.7(a) of the regulations, which are the criteria DHHS Regional Offices will use to decide which family planning projects to fund and in what amount. The application shall not include activities that cannot be funded under Title X, such as abortion, fundraising, or lobbying activities.
Projects must adhere to:
Section 59.5 and all other applicable provisions of the regulations, which list the requirements to be met by each project supported by Title X.
The applicable requirements of these Program Guidelines for Project Grants for Family Planning Services.
Other Federal regulations which apply to grants made under Title X [59.10]. For assistance in identifying other relevant regulations, contact the Regional Office.
The notice of grant award will inform the grantee how long DHHS intends to support the project without requiring it to recompete for funds [59.8]. This period of funding is called the “project period.” The project will be funded in increments called “budget periods.” The budget period is normally twelve months, although shorter or longer budget periods may be established for compelling administrative or programmatic reasons.
All grantees must comply with the applicable legislative, regulatory and administrative requirements described in the Public Health Service Grants Policy Statement. A copy of the Public Health Service Grants Policy Statement may be obtained from the Office of Grants Management for Family Planning Services.
Use by any individual of project services must be solely on a voluntary basis. Individuals must not be subjected to coercion to receive services or to use or not to use any particular method of family planning. Acceptance of family planning services must not be a prerequisite to eligibility for, or receipt of, any other service or assistance from or participation in any other programs of the applicant [59.5(a)(2)].
Project personnel must be informed that they may be subject to prosecution under Federal law if they coerce or endeavor to coerce any person to undergo an abortion or sterilization procedure.
Every project must assure client confidentiality and provide safeguards for individuals against the invasion of personal privacy, as required by the Privacy Act. No information obtained by the project staff about individuals receiving services may be disclosed without the individual’s written consent, except as required by law or as necessary to provide services to the individual, with appropriate safeguards for confidentiality. Information may otherwise be disclosed only in summary, statistical, or other form that does not identify the individual [59.11].
Grantees must establish policies to prevent employees, consultants, or members of governing or advisory bodies from using their positions for purposes of private gain for themselves or for others.
Grantees and/or delegates/contractors should ensure the existence of adequate liability coverage for all segments of the project funded under the grant, including all individuals providing services. Governing boards should obtain liability coverage for their members.
Grantees considering clinical or sociological research using Title X clients as subjects must adhere to the legal requirements governing human subjects research at 45 CFR Part 46, as applicable. A copy of these regulations may be obtained from the Regional Office. Grantees must advise the Regional Office in writing of research projects involving Title X clients or resources in any segment of the project.
Family planning services under Title X grant authority may be offered by grantees directly and/or by delegate/contract agencies operating under the umbrella of the grantee. However, the grantee is responsible for the quality, cost, accessibility, acceptability, reporting, and performance of the grant-funded activities provided by delegate/contract agencies. Grantees must therefore have a negotiated, written agreement with each delegate/contract agency and establish written standards and guidelines for all delegated project activities consistent with the appropriate section(s) of the Program Guidelines for Project Grants for Family Planning Services, as well as other applicable requirements such as Subpart C of 45 CFR Part 74, or Subpart C of 45 CFR Part 92. If a delegate/contract agency wishes to subcontract any of its responsibilities or services, a written negotiated agreement that is consistent with Title X requirements and approved by the grantee must be maintained by the delegate/contractor. Delegate/contract agencies should be invited to participate in the establishment of grantee standards and guidelines.
All projects receiving Title X funds must provide services of high quality and be competently and efficiently administered. To meet these requirements, each competitive application must include a plan which identifies overall goals and specific measurable objectives for the project period. The objectives may be directed to all clients or to specific groups of clients and must be consistent with Title X objectives. The plan must include an evaluation component that addresses and defines indicators by which the project intends to evaluate itself.
Grantees must maintain a financial management system that meets the standards specified in Subpart C of 45 CFR Part 74 or Subpart C of 45 CFR Part 92, as applicable, as well as any other requirements imposed by the Notice of Grant Award, and which complies with Federal standards to safeguard the use of funds. Documentation and records of all income and expenditures must be maintained as required.
! Charges, Billing, and Collections
A grantee is responsible for the implementation of policies and procedures for charging, billing, and collecting funds for the services provided by the project. The policies and procedures should be approved by the governing authority or board of the grantee and the Regional Office.
Clients must not be denied project services or be subjected to any variation in quality of services because of the inability to pay. Billing and collection procedures must have the following characteristics:
Charges must be based on a cost analysis of all services provided by the project. At the time of services, clients who are responsible for paying any fee for their services must be given bills directly. In cases where a third party is responsible, bills must be submitted to that party.
A schedule of discounts must be developed and implemented with sufficient proportional increments so that inability to pay is never a barrier to service. A schedule of discounts is required for individuals with family incomes between 101% and 250% of the Federal poverty level. Fees must be waived for individuals with family incomes above this amount who, as determined by the service site project director, are unable, for good cause, to pay for family planning services.
Clients whose documented income is at or below 100% of the Federal poverty level must not be charged, although projects must bill all third parties authorized or legally obligated to pay for services.
Individual eligibility for a discount must be documented in the client’s financial record.
Bills to third parties must show total charges without applying any discount.
Where reimbursement is available from Title XIX or Title XX of the Social Security Act, a written agreement with the Title XIX or the Title XX state agency at either the grantee level or delegate/contract agency level is required.
Bills to clients must show total charges less any allowable discounts.
Eligibility for discounts for minors who receive confidential services must be based on the income of the minor.
Reasonable efforts to collect charges without jeopardizing client confidentiality must be made.
A method for the “aging” of outstanding accounts must be established.
Voluntary donations from clients are permissible. However, clients must not be pressured to make donations, and donations must not be a prerequisite to the provision of services or supplies. Donations from clients do not waive the billing/charging requirements set out above.
Client income should be re-evaluated at least annually.
Effective financial management will assure the short and long term viability of the project, including the efficient use of grant funds. Technical assistance in achieving this objective is available from the Regional Office. Title X projects offering services that are not required by the statute, regulations or these Guidelines should whenever possible seek other sources of funding for such services before applying Title X funds to those activities.
Audits of grantees and delegate/contract agencies must be conducted in accordance with the provisions of 45 CFR Part 74, Subpart C, and 45 CFR Part 92, Subpart C, as applicable. The audits must be conducted by auditors meeting established criteria for qualifications and independence.
Facilities in which project services are provided should be geographically accessible to the population served and should be available at times convenient to those seeking services, i.e., they should have evening and/or weekend hours in addition to daytime hours. The facilities should be adequate to provide the necessary services and should be designed to ensure comfort and privacy for clients and to expedite the work of the staff. Facilities must meet applicable standards established by the Federal, state and local governments (e.g., local fire, building and licensing codes).
Projects must comply with 45 CFR Part 84, which prohibits discrimination on the basis of handicap in Federally assisted programs and activities, and which requires, among other things, that recipients of Federal funds operate their Federally assisted programs so that, when viewed in their entirety, they are readily accessible to people with disabilities. A copy of Part 84 may be obtained from the Regional office. Projects must also comply with any applicable provisions of the Americans With Disabilities Act (Public Law 101-336).
Emergency situations may occur at any time. All projects must therefore have written plans and procedures for the management of emergencies.
Grantees and delegate/contract agencies are reminded of their obligation to establish and maintain personnel policies that comply with applicable Federal and state requirements, including Title VI of the Civil Rights Act, Section 504 of the Rehabilitation Act of 1973, and Title I of the Americans With Disabilities Act. These policies should include, but need not be limited to, staff recruitment, selection, performance evaluation, promotion, termination, compensation, benefits, and grievance procedures. Project staff should be broadly representative of all significant elements of the population to be served by the project, and should be sensitive to and able to deal effectively with the cultural and other characteristics of the client population [59.5 (b)(10)].
Grantees must also ensure that:
Projects are administered by a qualified project director;The clinical care component of the project operates under the responsibility of a medical director who is a licensed and qualified physician with special training or experience in family planning;
Protocols exist that provide all project personnel with guidelines for client care; Personnel records are kept confidential;Licenses of applicants for positions requiring licensure are verified prior to employment and that there is documentation that licenses are kept current.
Projects must provide for the orientation and in-service training of all project personnel, including the staffs of delegate agencies and service sites. All project personnel should participate in continuing education related to their activities. Documentation of continuing education should be maintained and used in evaluating the scope and effectiveness of the staff training program.
Training through regional training centers is available to all projects under the Title X program. In addition to training, grantees may receive technical assistance for specific project activities. Technical assistance is provided by contract from the OPA and administered through the Regional Office. Information on training and technical assistance is available from the Regional Office.
comply with the financial and other reporting requirements of 45 CFR Part 74 or 45 CFR Part 92, as applicable; and
comply with other reporting requirements as required by DHHS.
An advisory committee of five to nine members (the size of the committee can differ from these limits with written documentation and approval from the Regional Office) who are broadly representative of the community must review and approve all informational and educational (I&E) materials developed or made available under the project prior to their distribution to assure that the materials are suitable for the population and community for which they are intended and to assure their consistency with the purposes of Title X. Oversight responsibility for the I&E committee(s) rests with the grantee. The grantee may delegate the I & E operations for the review and approval of materials to delegate/contract agencies.
The I&E committee(s) must:
Consider the educational and cultural backgrounds of the individuals to whom the materials are addressed;
Consider the standards of the population or community to be served with respect to such materials; Review the content of the material to assure that the information is factually correct;Determine whether the material is suitable for the population or community to which it is to be made available; and
Establish a written record of its determinations [59.6].The committee(s) may delegate responsibility for the review of the factual, technical, and clinical accuracy to appropriate project staff. However, final approval of the I& E material rests with the committee(s).
Boards and advisory committees for family planning services should be broadly representative of the population served.
Title X grantees and delegate/contract agencies must provide an opportunity for participation in the development, implementation, and evaluation of the project (1) by persons broadly representative of all significant elements of the population to be served, and (2) by persons in the community knowledgeable about the community’s needs for family planning services [59.5(b)(10)].
The I& E advisory committee may serve the community participation function if it meets the above requirements, or a separate group may be identified. In either case, the grantee project plan must include a plan for community participation. The community participation committee must meet annually or more often as appropriate.
Each family planning project must provide for community education programs [59.5(b)(3)]. This should be based on an assessment of the needs of the community and should contain an implementation and evaluation strategy.
Community education should serve to enhance community understanding of the objectives of the project, make known the availability of services to potential clients, and encourage continued participation by persons to whom family planning may be beneficial.
To facilitate community awareness of and access to family planning services, projects must establish and implement planned activities whereby their services are made known to the community [59.5(b)(3)]. Projects should review a range of strategies and assess the availability of existing resources and materials. Promotion activities should be reviewed annually and be responsive to the changing needs of the community. For more information, contact the Regional Offices.
Unless otherwise stipulated, publications resulting from activities conducted under the grant need not be submitted to DHHS for prior approval. The word "publication" is defined to include computer software. Grantees should ensure that publications developed under Title X do not contain information which is contrary to program requirements or to accepted clinical practice. Federal grant support must be acknowledged in any publication. Except as otherwise provided in the conditions of the grant award, the author is free to arrange for copyright without DHHS approval of publications, films, or similar materials developed from work supported by DHHS. Restrictions on motion picture film production are outlined in the Public Health Service Grants Policy Statement. Any such copyrighted materials shall be subject to a royalty-free, non-exclusive, and irrevocable right of the Government to reproduce, publish, or otherwise use such materials for Federal purposes and to authorize others to do so [45 CFR 74.36][45 CFR 92.34 ].
Family planning projects must comply with Government-wide regulations, 37 CFR Part 401, which apply to the rights to inventions made under government grants, contracts and cooperative agreements.
Projects funded under Title X must provide clinical, informational, educational, social and referral services relating to family planning to clients who want such services. All projects must offer a broad range of acceptable and effective medically approved family planning methods and services either onsite or by referral [59.5(a)(1)]. Projects should make available to clients all methods of contraception approved by the Federal Food and Drug Administration.
Part II of this document has been developed to assist grantees in determining those services which will be provided to fulfill the mission of Title X.
Projects must provide services stipulated in the law or regulations, or which are required by these Guidelines for the provision of high quality family planning services.
Projects may also provide those services that are intended to promote the reproductive and general health care of the family planning client population.
The service plan is the component of the grantee's project plan, as set forth in the competitive application, which identifies those services to be provided to clients under Title X by the project. As part of the project plan, all grantees must assure that delegate/contractors have written clinical protocols and plans for client education, approved by the grantee and signed by the service site Medical Director, which outline procedures for the provision of each service offered and which are in accordance with state laws. Clinical protocols must be consistent with the requirements of these Guidelines.
Under exceptional circumstances, a waiver from a particular requirement may be obtained from the Regional Office upon written request from a grantee. In submitting a request for an exception, the grantee must provide epidemiologic, clinical, and other supportive data to justify the request and the duration of the waiver.
The services provided to family planning clients, and the sequence in which they are provided, will depend upon the type of visit and the nature of the service requested. However, the following components must be offered to and documented on all clients at the initial visit:
Presentation of relevant information and educational materials, based upon client needs and knowledge;
Interactive process in which a client is assisted in making an informed choice;Explanation of all procedures and obtaining a general consent covering examination and treatment and, where applicable, a method specific informed consent form;
