Michigan
Title X
Family Planning Program
Standards & Guidelines Manual
Michigan Department of Health and Human Services
Last Updated: December 2018
2
TABLE OF CONTENTS
Introduction to the Document
Introduction ................................................................................................................................ 7
I. Federal and State Legislation, Requirements and Resources
A. Federal Legislation, OPA and HHS Regulations and Resources
1. Title X Family Planning Program ................................................................................................ 9
A. Title X Statute ...................................................................................................................... 10
2. Title X Federal Program Guidelines, Guidance and Resources
A. Program Guidelines, Tools and Documents ........................................................................ 23
B. Program Priorities, Key Issues and Legislative Mandates ................................................... 24
C. Title X Program Description ................................................................................................. 26
D. OPA Program Policy Notice PPN Series
OPA PPN 2016-11 - Integrating with Primary Care Providers………………….……………………....27
OPA PPN 2014-01 - Confidential Services to Adolescents ................................................... 31
E. FPAR: Family Planning Annual Reporting Requirement and Instructions ........................... 32
F. Title X Resources and Links .................................................................................................. 33
G. HHS Administrative Regulations that apply to Title X Grants and Programs ...................... 34
3. Civil Rights Act of 1964 ............................................................................................................... 35
4. Non-Discrimination on the Basis of Handicap (45 CFR Part 84) ................................................ 35
5. Occupational Safety and Health Standards (29 CFR Part 1910 Subpart E) ............................... 35
6. Health Insurance Portability and Accountability act of 1996 (HIPAA) ....................................... 36
7. Human Trafficking Laws ............................................................................................................. 39
8. Patient Protection and Affordable Care Act (ACA) .................................................................... 40
B. Michigan Family Planning Information: Legislation, Resources and Requirements
1. Michigan Public Health Code Family Planning Authority .......................................................... 41
2. Appropriations ........................................................................................................................... 42
3. Public Health Codes .................................................................................................................... 42
A. HIV Testing Law .................................................................................................................. 42
B. Pharmacy Law .................................................................................................................... 42
C. Mental Health Services ...................................................................................................... 42
D. Substance Abuse ................................................................................................................ 42
E. Public Act 360 of 2002 ....................................................................................................... 42
F. Confidentiality of Minors ................................................................................................... 42
G. Adoption ............................................................................................................................ 43
H. Licensing for Health Care Professionals ............................................................................. 43
I. Drug Control License & Dispensing of Pharmaceuticals .................................................... 43
J. Sexual Coercion legislation…………………………………………………………………………………………….44
K. Child Protection and Mandated Reported Legislation……………………………………………………45
L. Michigan Human Trafficking Law ....................................................................................... 45
M. Expedited Partner Therapy (EPT) Legislation and Guidance………………………...…………………47
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4. Additional Michigan and Medicaid Resources
A. Zika virus information…………………………………………………………………………………...................48
B. Immunizations……………………………………………………………………………………………………………...48
C. HIV testing, counseling and care coordination…………………………………...…………………………48
D. Genetic referrals……………………………………………………………………………………………………………48
E. Medicaid Policy, Manual and Billing information.………………………………………………………….48
5. Michigan title X Family Planning Program Requirements
A. Minimum Family Planning Program Requirements (MPRs) .............................................. 49
B. MDHHS Minimum Family Planning Reporting Requirements (MRRs)…………………………….52
C. Michigan Annual Plan Instructions …. ................................................................................ 54
D. Financial Management and Audit Requirements .............................................................. 56
II. Administrative Program Requirements
A. Overview of Program Requirements ......................................................................................... 59
B. Eligibility, Application and Grant Process
1. Applicability .............................................................................................................................. 59
2. Definitions ................................................................................................................................ 60
3. Eligibility ................................................................................................................................... 62
4. Application ................................................................................................................................ 64
5. Funding ..................................................................................................................................... 64
6. Notice of Award ........................................................................................................................ 65
7. Use of Grant Funds ................................................................................................................... 65
C. Project Management and Administration
8. Project Management and Administration ................................................................................. 66
8.1 Voluntary Participation ........................................................................................................ 66
8.2 Prohibition of Abortion ........................................................................................................ 67
8.3 Structure and Management ................................................................................................. 67
8.4 Charges, Billing and Collections ........................................................................................... 68
8.5 Project Personnel ................................................................................................................. 70
8.
6 Staff Training ........................................................................................................................ 71
8.7 Planning and Evaluation (Annual Plan) ................................................................................ 72
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. Project Services and Clients ......................................................................................................... 73
9.1 Priority to Low-Income Clients ............................................................................................ 73
9.2 Protecting the Dignity of the Individual .............................................................................. 73
9.3 Non-Discrimination ............................................................................................................. 73
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.4 Provision of Related Social Services .................................................................................... 73
9.5 Referrals and Coordination ................................................................................................. 73
9.6 Provision of Family Planning Services using Written Clinical Protocols……………………………73
9.7 Provision of Family Planning and Related Medical Services ............................................... 73
9.8 Provision of a Broad Range of Family Planning Methods ................................................... 73
9.9 Provision of Services without any Residency Requirement ................................................ 73
9.10 Provision of Pregnancy Diagnosis and Counseling ............................................................ 73
9.11 Provision of Pregnancy Options Counseling ...................................................................... 73
9.12 Compliance with Legislative Mandates ............................................................................. 74
10. Confidentiality .................................................................................................................... 74
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11. Community Participation, Education and Project Promotion ............................................ 75
12
.
Approval of Information and Education (I&E) Materials ................................................... 76
D
. Additional Administrative Requirements
13.1 Facilities and Accessibility of Services (LEP/Disability Act) ................................................ 78
13.2 Emergency Management ................................................................................................... 79
13.3 Standards of Conduct ......................................................................................................... 79
13.4 Human Subjects Clearance for Research ........................................................................... 80
13.5 Financial and Reporting Requirements .............................................................................. 80
14 Additional Conditions ........................................................................................................ 81
15 Closeout Requirements ...................................................................................................... 81
16 Other Applicable HHS Regulations & Statutes .................................................................. 81
III. Clinical Services
A. Introduction
17 Introduction ........................................................................................................................ 84
18 Service Plans and Protocols ................................................................................................ 84
19 Procedural Outline .............................................................................................................. 85
20 Client Encounters................................................................................................................ 86
20.1 Checklist of FP and Related Preventive Health Services for Women ................................. 87
20.2 Checklist of FP and Related Preventive Health Services for Men ...................................... 88
B
. F
amily Planning Service
21. Contraceptive Services ......................................................................................................... 89
Broad Range Contraceptives ............................................................................................... 89
The Clinic Visit ...................................................................................................................... 90
Medical History for Female Clients ............................................................................ 90
Medical History for Male Clients……………………………………………………………………………91
Physical and Laboratory Assessment ......................................................................... 91
Client Education and Counseling ............................................................................... 91
Counseling Adolescent Clients ................................................................................... 92
Counseling Returning Clients ..................................................................................... 93
Preventive Health Promotion and Referral ............................................................... 93
22. Preconception Health Services .................................................................................... 93
Medical History for Female Clients ...................................................................................... 93
Medical History for Male Clients ......................................................................................... 94
Physical Examination for all Clients ..................................................................................... 94
C
lient Plan and Education .................................................................................................... 94
Referral ................................................................................................................................ 95
23. Achieving Pregnancy Services ............................................................................................. 95
Client Assessment ................................................................................................................ 95
Client Education and Counseling ......................................................................................... 96
Education on Maximizing Fertility Awareness………………………………………………………………… 96
Referral ................................................................................................................................ 97
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24. Pregnancy Diagnosis and Counseling ................................................................................. 97
Pregnancy Diagnosis Services .............................................................................................. 97
The Positive Test Visit .......................................................................................................... 97
Pregnancy Options Counseling and Referrals ...................................................................... 97
Negative Test Visit, Counseling and Referrals ..................................................................... 98
25. Basic Infertility Services ...................................................................................................... 98
The Clinic Visit ...................................................................................................................... 98
Basic Infertility Care for Women ......................................................................................... 99
Medical History for Women ......................................................................................... 99
Physical Exam for Women ............................................................................................ 99
Basic Infertility Care for Men………………………………………………………………………………………….100
Medical History for Men………………………………………………………………………………………….100
Physical Exam for Men…………………………………………………………………………………………….100
Infertility Counseling ............................................................................................................ 100
Referral ................................................................................................................................ 100
26 Sexually Transmitted Disease Services .............................................................................. 100
Reproductive Life Plan ......................................................................................................... 101
Medical History .................................................................................................................... 101
Physical Exam ....................................................................................................................... 101
Laboratory Testing ............................................................................................................... 101
Treatment……………………………………………………………………………………………………………………….102
Expedited Partner Therapy……………………………………………………………………………………………...102
Counseling ........................................................................................................................... 103
Referral……………………………………………………………………………………………………………………………103
Mandatory reporting ........................................................................................................... 103
27. Gynecologic Services ........................................................................................................... 103
28. Related Preventive Health Services
Clinical Breast Exam ............................................................................................................. 103
Cervical Cytology (Pap Testing)............................................................................................ 103
Pelvic Examination ............................................................................................................... 103
Mammography .................................................................................................................... 104
Genital Examination for Adolescent Males ......................................................................... 104
29. Quality Clinical Management
Referrals and Follow-up ....................................................................................................... 104
Pharmaceuticals ................................................................................................................... 105
Medical Emergencies………………………………………………………………………………………………………107
Medical Records…………………………………………………...……………………………………………………….107
Quality Improvement……………………………………………………………………………………………….…….108
Medical/Chart Audit Requirements…………………………………………………………………………….….109
IV. Program Monitoring
A. Accreditation Visits and Site visit Reviews .......................................................................... 112
B. Technical Assistance and Monitoring .................................................................................. 114
C. MDHHS Financial Program Audit ......................................................................................... 115
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V. MDHHS Title X Training
A. Coordinators Meeting .......................................................................................................... 117
B. Michigan Annual Family Planning Update ........................................................................... 117
C. Additional Staff and Sub-recipient Agency Training ............................................................ 117
D. National Meetings, Conferences and Training Centers ....................................................... 118
E. Family Planning Advisory Council (FPAC) ............................................................................ 119
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Introduction
The Michigan Department of Health and Human Services (MDHHS) Family Planning Program
philosophy is consistent with the Title X Family Planning Program. Family Planning assists individuals
in determining the number and spacing of their children through the provision of affordable, voluntary
family planning services including provision of a broad range of contraceptive methods, education and
related preventive health services. By assisting the establishment and operation of voluntary family
planning projects throughout Michigan, the program positively impacts the health and well-being of
individuals and families. Services provided through family planning clinics allow women and men to
make well-informed reproductive health choices. MDHHS funded family planning clinics are designed to
address the unmet family planning needs of low-income women and men and provide access to
populations with special needs. No one is denied services because of inability to pay.
MDHHS has primary responsibility in Michigan to administer state and federal funds for family planning.
The provision of voluntary family planning services is authorized under the Michigan Public Health
Code, Section 333.9131-9133. Local health departments may provide services under supervision of
MDHHS and must publicize the availability of services. The MDHHS Title X Family Planning Program
Standards and Guidelines provide policy and guidance for sub-recipients to provide family planning
services. It is based on the Title X statute, Office of Population Affairs (OPA) Title X Guidelines, federal
and state laws, regulations, and annual funding processes. The manual forms the basis for monitoring
MDHHS Title X projects.
The MDHHS Title X Family Planning Program Standards and Guidelines align with the Office of
Population Affairs (OPA) Title X Family Planning Guidelines published in April, 2014. The guidelines
are contained in the following two documents:
1. Program Requirements for Title X Funded Family Planning Projects. This document is derived
from the Title X statute, implementing regulations and other requirements under Title X of the
Public Health Service Act. It describes the Title X program requirements for funded projects.
http://www.hhs.gov/opa/sites/default/files/ogc-cleared-final-april.pdf
2. Providing Quality Family Planning Services (QFP) was developed jointly by the Centers for
Disease Control and Prevention (CDC) and OPA and published as a CDC MMWR
Recommendations and Report. The QFP presents clinical recommendations for providing family
planning services based on the best available scientific evidence. The QFP is intended for
providers across all practice settings and serves as the clinical guidance for Title X projects.
http://www.cdc.gov/mmwr/pdf/rr/rr6304.pdf
The MDHHS Title X Family Planning Program Standards and Guidelines follows these two documents.
The MDHHS document is one manual with five sections: Introduction to the Document, (I) Federal and
State Laws and Resources, (II) Administrative Program Requirements, (III) Clinical Services, (IV)
Program Monitoring, and (V) Training. The program administration section (Section II) describes
requirements outlined in the OPA Title X program requirements document. The clinical services section
(Section III) follows the outline and recommendations in the QFP document.
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SECTION I
Federal and State Legislation, Regulations
And Resources
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A. Federal Legislation, OPA and HHS Regulations,
Documents and Resources
The Federal Title X Family Planning Program
To assist individuals in determining the number and spacing of their children through the provision of
affordable, voluntary family planning services, Congress enacted the Family Planning Services and
Population Research Act of 1970 (Public Law 91-572). The law amended the Public Health Service (PHS)
Act to add Title X, “Population Research and Voluntary Family Planning Programs.” Section 1001 of the
PHS 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).”
The Title X Family Planning Program is the only Federal program dedicated solely to the provision to of
family planning and related preventive health services. The program is designed to provide contraceptive
supplies and information to all who want and need them, with priority given to persons from low-income
families. Title X-funded projects are required to offer a broad range of acceptable and effective medically
approved (U.S. Food & Drug Administration (FDA) approved) contraceptive methods and related
services on a voluntary and confidential basis. Title X services include the delivery of related preventive
health services, including patient education and counseling; cervical and breast cancer screening; sexually
transmitted disease (STD) and human immunodeficiency virus (HIV) prevention education, testing, and
referral; and pregnancy diagnosis and counseling. By law, Title X funds may not be used in programs
where abortion is a method of family planning.
The Title X Family Planning Program is administered by the Office of Population Affairs (OPA), Office
of the Assistant Secretary for Health (OASH), within the U.S. Department of Health and Human Services
(HHS). OASH facilitates the application process and setting funding levels according to 42 CFR 59.7(a).
Award decisions are made by the Regional Health Administrator in consultation with the Deputy Assistant
Secretary for Population Affairs and the Assistant Secretary for Health or their designees. The HHS
Regional Offices monitor program performance of Title X grantees in each region.
The Title X Family Planning Guidelines of 2014 consist of two parts, 1) Program Requirements for Title
X Funded Family Planning Projects (hereafter referred to as Title X Program Requirements) and 2)
Providing Quality Family Planning Services: Recommendations of CDC and the U.S. Office of
Population Affairs (the QFP). These two documents were developed to assist current and prospective
grantees in understanding and implementing the family planning services grants program authorized by
Title X of the PHS Act (42 U.S.C 300 et seq.) These documents also form the basis for monitoring
grantee projects under the Title X program.
Prospective applicants and MDHHS sub-recipients should be familiar with these regulations.
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Title X Statute
TITLE X - POPULATION RESEARCH AND VOLUNTARY FAMILY
PLANNING PROGRAMS
PROJECT GRANTS AND CONTRACTS FOR FAMILY PLANNING SERVICES
SEC. 1001 [300]
(a) The Secretary is authorized 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). To the extent practicable, entities
which receive grants or contracts under this subsection shall encourage family 1 participation in projects
assisted under this subsection.
(b) In 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. Local and regional
entities shall be assured the right to apply for direct grants and contracts under this section, and the
Secretary shall by regulation fully provide for and protect such right.
(c) The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of
such grant by the fair market value of any supplies or equipment furnished the grant recipient by the
Secretary. The amount by which any such grant is so reduced shall be available for payment by the
Secretary of the costs incurred in furnishing the supplies or equipment on which the reduction of such
grant is based. Such amount shall be deemed as part of the grant and shall be deemed to have been paid to
the grant recipient.
(d) For the purpose of making grants and contracts under this section, there are authorized to be
appropriated $30,000,000 for the fiscal year ending June 30, 1971; $60,000,000 for the fiscal year ending
June 30, 1972; $111,500,000 for the fiscal year ending June 30, 1973, $111,500,000 each for the fiscal
years ending June 30, 1974, and June 30, 1975; $115,000,000 for fiscal year 1976;
$115,000,000 for the fiscal year ending September 30, 1977;
$136,400,000 for the fiscal year ending September 30, 1978;
$200,000,000 for the fiscal year ending September 30, 1979;
$230,000,000 for the fiscal year ending September 30, 1980;
$264,500,000 for the fiscal year ending September 30, 1981;
$126,510,000 for the fiscal year ending September 30, 1982;
$139,200,000 for the fiscal year ending September 30, 1983;
$150,030,000 for the fiscal year ending September 30, 1984; and
$158,400,000 for the fiscal year ending September 30, 1985.
1 So in law. See section 931(b) (I) of Public Law 97-35 (95 Stat. 570). Probably should be “family”.
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FORMULA GRANTS TO STATES FOR FAMILY PLANNING SERVICES
SEC. 1002 [300a]
(a) The Secretary is authorized to make grants, from allotments made under subsection (b), to State health
authorities to assist in planning, establishing, maintaining, coordinating, and evaluating family planning
services. No grant may be made to a State health authority under this section unless such authority has
submitted, and had approved by the Secretary, a State plan for a coordinated and comprehensive program
of family planning services.
(b) The sums appropriated to carry out the provisions of this section shall be allotted to the States by the
Secretary on the basis of the population and the financial need of the respective States.
(c) For the purposes of this section, the term ''State'' includes the Commonwealth of Puerto Rico, the
Northern Mariana Islands, Guam, American Samoa, the Virgin Islands, the District of Columbia, and the
Trust Territory of the Pacific Islands.
(d) For the purpose of making grants under this section, there are authorized to be appropriated
$10,000,000 for the fiscal year ending June 30, 1971; $15,000,000 for the fiscal year ending June 30,
1972; and $20,000,000 for the fiscal year ending June 30, 1973.
TRAINING GRANTS AND CONTRACTS; AUTHORIZATION OF APPROPRIATIONS
SEC. 1003 [300a-1]
(a) The Secretary is authorized to make grants to public or nonprofit private entities and to enter into
contracts with public or private entities and individuals to provide the training for personnel to carry out
family planning service programs described in section 1001 or 1002 of this title.
(b) For the purpose of making payments pursuant to grants and contracts under this section, there are
authorized to be appropriated $2,000,000 for the fiscal year ending June 30, 1971; $3,000,000 for the
fiscal year ending June 30, 1972; $4,000,000 for the fiscal year ending June 30, 1973; $3,000,000 each for
the fiscal years ending June 30, 1974 and June 30, 1975; $4,000,000 for fiscal year ending 1976;
$5,000,000 for the fiscal year ending September 30, 1977; $3,000,000 for the fiscal year ending
September 30, 1978; $3,100,000 for the fiscal year ending September 30, 1979; $3,600,000 for the fiscal
year ending September 30, 1980; $4,100,000 for the fiscal year ending September 30, 1981; $2,920,000
for the fiscal year ending September 30, 1982; $3,200,000 for the fiscal year ending September 30, 1983;
$3,500,000 for the fiscal year ending September 30, 1984; and $3,500,000 for the fiscal year ending
September 30, 1985.
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RESEARCH
SEC. 1004 [300a-2]
The Secretary may:
(1) Conduct, and
(2) make grants to public or nonprofit private entities and enter into contracts with public or
private entities and individuals for projects for, research in the biomedical, contraceptive
development, behavioral, and program implementation fields related to family planning and
population.
INFORMATIONAL AND EDUCATIONAL MATERIALS
SEC. 1005 [300a-3]
(a) The Secretary is authorized to make grants to public or nonprofit private entities and to enter
into contracts with public or private entities and individuals to assist in developing and making
available family planning and population growth information (including educational materials) to
all persons desiring such information (or materials).
(b) For the purpose of making payments pursuant to grants and contracts under this section, there
are authorized to be appropriated $750,000 for the fiscal year ending June 30, 1971; $1,000,000
for the fiscal year ending June 30, 1972; $1,250,000 for the fiscal year ending June 30, 1973;
$909,000 each for the fiscal years ending June 30, 1974, and June 30, 1975; $2,000,000 for fiscal
year 1976; $2,500,000 for the fiscal year ending September 30, 1977; $600,000 for the fiscal
year ending September 30, 1978; $700,000 for the fiscal year ending September 30, 1979;
$805,000 for the fiscal year ending September 30, 1980; $926,000 for the fiscal year ending
September 30, 1981; $570,000 for the fiscal year ending September 30, 1982; $600,000 for the
fiscal year ending September 30, 1983; $670,000 for the fiscal year ending September 30, 1984;
and $700,000 for the fiscal year ending September 30, 1985.
REGULATIONS AND PAYMENTS
SEC. 1006 [300a-4]
(a) Grants and contracts made under this subchapter shall be made in accordance with such
regulations as the Secretary may promulgate. The amount of any grant under any section of this
title shall be determined by the Secretary; except that no grant under any such section for any
program or project for a fiscal year beginning after June 30, 1975, may be made for less than 90
per centum of its costs (as determined under regulations of the Secretary) unless the grant is to be
made for a program or project for which a grant was made (under the same section) for the fiscal
year ending June 30, 1975, for less than 90 per centum of its costs (as so determined), in which
case a grant under such section for that program or project for a fiscal year beginning after that
date may be made for a percentage which shall not be less than the percentage of its costs for
which the fiscal year 1975 grant was made.
14
(b) Grants under this title shall be payable in such installments and subject to such conditions as
the Secretary may determine to be appropriate to assure that such grants will be effectively
utilized for the purposes for which made.
(c) A grant may be made or contract entered into under section 1001 or 1002 for a family
planning service project or program only upon assurances satisfactory to the Secretary that:
(1) Priority will be given in such project or program to the furnishing of such services to
persons from low-income families; and
(2) no charge will be made in such project or program for services provided to any person
from a low-income family except to the extent that payment will be made by a third party
(including a government agency) which is authorized or is under legal obligation to pay such
charge.
For purposes of this subsection, the term ''low-income family'' shall be defined by the
Secretary in accordance with such criteria as he may prescribe so as to insure that economic
status shall not be a deterrent to participation in the programs assisted under this title.
(d)
(1) A grant may be made or a contract entered into under section 1001 or 1005 only upon
assurances satisfactory to the Secretary that informational or educational materials developed
or made available under the grant or contract will be suitable for the purposes of this title and
for the population or community to which they are to be made available, taking into account
the educational and cultural background of the individuals to whom such materials are
addressed and the standards of such population or community with respect to such materials.
(2) In the case of any grant or contract under section 1001, such assurances shall provide for
the review and approval of the suitability of such materials, prior to their distribution, by an
advisory committee established by the grantee or contractor in accordance with the
Secretary's regulations. Such a committee shall include individuals broadly representative of
the population or community to which the materials are to be made available.
VOLUNTARY PARTICIPATION
SEC. 1007 [300a-5]
The acceptance by any individual of family planning services or family planning or population
growth information (including educational materials) provided through financial assistance under
this title (whether by grant or contract) shall be voluntary and shall not be a prerequisite to
eligibility for or receipt of any other service or assistance from, or to participation in, any other
program of the entity or individual that provided such service or information.
PROHIBITION OF ABORTION
SEC. 1008 1 [300a-6]
None of the funds appropriated under this title shall be used in programs where abortion is a
method of family planning.
1 Section 1009 was repealed by section 601(a) (1) (G) of Public Law 105-362 (112 Stat. 3285).
15
PUBLIC HEALTH SERVICE HHS PT. 59
(2) The trainee is not eligible or able to continue in
attendance in accordance with its standards and
practices.
[45 FR 73658, Nov. 6, 1980. Redesignated at 61
FR 6131, Feb. 16, 1996]
§ 5
8.232 What additional Department
regulations apply to grantees?
Several other Department regulations apply to
grantees. They include, but are not limited to:
42 CFR part 50, subpart D—Public Health
Service grant appeals procedure
45 CFR part 16—Procedures of the Departmental
Grant Appeals Board
45 CFR part 46—Protection of human subjects
45 CFR part 74—Administration of grants
45 CFR part 80—Nondiscrimination under programs
receiving Federal assistance through the Department of
Health and Human Services effectuation of title VI of
the Civil Rights Act of 1964
45 CFR part 81—Practice and procedure for hearings
under part 80 of this title
45 CFR part 83—Regulation for the administration and
enforcement of sections 794 and 855 of the Public
Health Service Act
45 CFR part 84—Nondiscrimination on the basis of
handicap in programs and activities receiving or
benefiting from Federal financial assistance
45 CFR part 86—Nondiscrimination on the basis of sex
in education programs and activities receiving or
benefiting from Federal financial assistance
45 CFR part 91—Nondiscrimination on the basis of age
in HHS programs or activities receiving Federal
financial assistance
45 CFR part 93—New restrictions on lobbying
[49 FR 38116, Sept. 27, 1984. Redesignated and
amended at 61 FR 6131, Feb. 16, 1996]
§
58.233 What other audit and inspection
requirements apply to grantees?
Each entity which receives a grant under this
subpart must meet the requirements of 45 CFR part
74 concerning audit and inspection.
[61 FR 6131, Feb. 16, 1996; 61 FR 51020, Sept.
30, 1996]
§ 58.234 Additional conditions.
The Secretary may impose additional conditions
in the grant award before or at the time of the
award if he or she determines that these conditions
are necessary to assure or protect the advancement
of the approved activity, the interest of the public
health, or the conservation of grant funds.
[45 FR 73658, Nov. 6, 1980. Redesignated at 61 FR
6131, Feb. 16, 1996]
Subparts E–F [Reserved]
P
ART 59—GRANTS FOR FAMILY
PLANNING SERVICES
Subpart A—Project Grants for Family
Planning Services
Sec.
59.1 To what programs do these regulations apply?
59.2 Definitions.
59.3 Who is eligible to apply for a family planning
services grant?
59.4 How does one apply for a family planning
services grant?
59.5 What requirements must be met by a family
planning project?
59.6 What procedures apply to assure the
suitability of informational and educational
material?
59.7 What criteria will the Department of Health
and Human Services use to decide which family
planning services projects to fund and in what
amount?
59.8 How is a grant awarded?
59.9 For what purposes may grant funds be used?
59.10 What other HHS regulations apply to grants
under this subpart?
59.11 Confidentiality.
59.12 Additional conditions.
S
ubpart B [Reserved]
S
ubpart C—Grants for Family Planning
Service Training
59.201 Applicability.
59.202 Definitions.
59.203 Eligibility.
59.204 Application for a grant.
59.205 Project requirements.
59.206 Evaluation and grant award.
59.207 Payments.
59.208 Use of project funds.
59.209 Civil rights.
59.210 Inventions or discoveries.
59.211 Publications and copyright.
59.212 grantee accountability.
59.213 [Reserved]
59.214 Additional conditions.
59.215 Applicability of 45 CFR part 74.
S
ubpart A—Project Grants for
Family Planning Services
AUTHORITY: 42 U.S.C. 300a–4.
SOURCE: 65 FR 41278, July 3, 2000, unless otherwise
noted.
16
§ 59.1 To what programs do these
regulations apply?
The regulations of this subpart are applicable to
the award of grants under section 1001 of the
Public Health Service Act (42 U.S.C. 300) to assist
in the establishment and operation of voluntary
family planning projects. These projects shall
consist of the educational, comprehensive medical,
and social services necessary to aid individuals to
determine freely the number and spacing of their
children.
[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10,
2000]
§ 59.2 Definitions.
As used in this subpart:
Act means the Public Health Service Act, as
amended.
Family means a social unit composed of one
person, or two or more persons living together, as
a household.
Low income family means a family whose total
annual income does not exceed 100 percent of the
most recent Poverty Guidelines issued pursuant to
42 U.S.C. 9902(2). ‘‘Low-income family’’ also
includes members of families whose annual family
income exceeds this amount, but who, as
determined by the project director, are unable, for
good reasons, to pay for family planning services.
For example, unemancipated minors who wish to
receive services on a confidential basis must be
considered on the basis of their own resources.
Nonprofit, as applied to any private agency,
institution, or organization, means that no part of
the entity’s net earnings benefit, or may lawfully
benefit, any private shareholder or individual.
Secretary means the Secretary of Health and
Human Services and any other officer or employee
of the Department of Health and Human Services
to whom the authority involved has been
delegated.
State includes, in addition to the several States,
the District of Columbia, Guam, the
Commonwealth of Puerto Rico, the Northern
Mariana Islands, the U.S. Virgin Islands,
American Samoa, the U.S. Outlying Islands
(Midway, Wake, et. al.), the Marshall Islands, the
Federated State of Micronesia and the Republic of
Palau.
[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10,
2000]
§ 59.3 Who is eligible to apply for a family
planning services grant?
Any public or nonprofit private entity in a State
may apply for a grant under this subpart.
§ 59.4 How does one apply for a family
planning services grant?
(a) Application for a grant under this subpart
shall be made on an authorized form.
(b) An individual authorized to act for the
applicant and to assume on behalf of the applicant
the obligations imposed by the terms and
conditions of the grant, including the regulations of
this subpart, must sign the application.
(c) The application shall contain—
(1) A description, satisfactory to the Secretary, of
the project and how it will meet the requirements
of this subpart;
(2) A budget and justification of the amount of
grant funds requested;
(3) A description of the standards and
qualifications which will be required for all
personnel and for all facilities to be used by the
project; and
(4) Such other pertinent information as the
Secretary may require.
§ 59.5 what requirement s must be met by a
family planning project?
(a) Each project supported under this part must:
(1) Provide a broad range of acceptable and
effective medically approved family planning
methods (including natural family planning
methods) and services (including infertility
services and services for adolescents). If an
organization offers only a single method of family
planning, it may participate as part of a project as
long as the entire project offers a broad range of
family planning services.
(2) Provide services without subjecting
individuals to any coercion to accept services or to
employ or not to employ any particular methods of
family planning. Acceptance of services must be
solely on a voluntary basis and may not be made a
prerequisite to eligibility for, or receipt of, any
other services, assistance from or participation in
any other program of the applicant.
(3) Provide services in a manner which protects
the dignity of the individual.
(4) Provide services without regard to religion,
race, color, national origin, handicapping
condition, age, sex, number of pregnancies, or
marital status.
(5) Not provide abortion as a method of family
planning. A project must:
(i) Offer pregnant women the opportunity to be
provided information and counseling regarding
each of the following options:
(A) Prenatal care and delivery;
(B) Infant care, foster care, or adoption; and
(C) Pregnancy termination.
17
(ii) If requested to provide such information and
counseling, provide neutral, factual information
and nondirective counseling on each of the
options, and referral upon request, except with
respect to any option(s) about which the pregnant
woman indicates she does not wish to receive such
information and counseling.
(6) Provide that priority in the provision of
services will be given to persons from low-income
families.
(7) Provide that no charge will be made for services
provided to any persons from a low-income family
except to the extent that payment will be made by a
third party (including a government agency) which is
authorized to or is under legal obligation to pay this
charge.
(8) Provide that charges will be made for services
to persons other than those from low-income
families in accordance with a schedule of discounts
based on ability to pay, except that charges to
persons from families whose annual
income exceeds 250 percent of the levels set forth
in the most recent Poverty Guidelines issued
pursuant to 42 U.S.C. 9902(2) will be made in
accordance with a schedule of fees designed to
recover the reasonable cost of providing services.
(9) If a third party (including a Government
agency) is authorized or legally obligated to pay
for services, all reasonable efforts must be made to
obtain the third-party payment without application
of any discounts. Where the cost of services is to
be reimbursed under title XIX, XX, or XXI of the
Social Security Act, a written agreement with the
title XIX, XX or XXI agency is required.
(10)(i) Provide that if an application relates to
consolidation of service areas or health resources
or would otherwise affect the operations of local or
regional entities, the applicant must document that
these entities have been given, to the maximum
feasible extent, an opportunity to participate in the
development of the application. Local and regional
entities include existing or potential subgrantees
which have previously provided or propose to
provide family planning services to the area
proposed to be served by the applicant.
1 Section 205 of Pub. L. 94–63 states: ‘‘Any (1) officer or
employee of the United States,(2) officer or employee of any
State, political subdivision of a State, or any other entity, which
administers or supervises the administration of any program
receiving Federal financial assistance, or (3) person who
receives, under any program receiving Federal assistance,
compensation for services, who coerces or endeavors to coerce
any person to undergo an abortion or sterilization procedure by
threatening such person with the loss of, or disqualification for
the receipt of, any
benefit or service under a program receiving
Federal financial assistance shall be fined not more than $1,000
or imprisoned for not more than one year, or both.’’
(ii) Provide an opportunity for maximum
participation by existing or potential sub-grantee in
the ongoing policy decision making of the project.
(11) Provide for an Advisory Committee as
required by § 59.6.
(b) In addition to the requirements of paragraph
(a) of this section, each project must meet each of
the following requirements unless the Secretary
determines that the project has established good
cause for its omission. Each project must:
(1) Provide for medical services related to family
planning (including physician’s consultation,
examination prescription, and continuing
supervision, laboratory examination, contraceptive
supplies) and necessary referral to other medical
facilities when medically indicated, and provide
for the effective usage of contraceptive devices and
practices.
(2) Provide for social services related to family
planning, including counseling, referral to and
from other social and medical services agencies,
and any ancillary services which may be necessary
to facilitate clinic attendance.
(3) Provide for informational and educational
programs designed to—
(i) Achieve community understanding of the
objectives of the program;
(ii) Inform the community of the availability of
services; and
(iii) Promote continued participation in the
project by persons to whom family planning
services may be beneficial.
(4) Provide for orientation and inservice training
for all project personnel.
(5) Provide services without the imposition of any
durational residency requirement or requirement
that the patient be referred by a physician.
(6) Provide that family planning medical services
will be performed under the direction of a
physician with special training or experience in
family planning.
(7) Provide that all services purchased for project
participants will be authorized by the project
director or his designee on the project staff.
(8) Provide for coordination and use of referral
arrangements with other providers of health care
services, local health and welfare departments,
hospitals, voluntary agencies, and health services
projects supported by other federal programs.
(9) Provide that if family planning services are
provided by contract or other similar arrangements
with actual providers of services, services will be
provided in accordance with a plan which
establishes rates and method of payment for
medical care. These payments must be made under
agreements with a schedule of rates and payment
procedures maintained by the grantee. The grantee
18
must be prepared to substantiate that these rates are
reasonable and necessary.
(10) Provide, to the maximum feasible extent, an
opportunity for participation in the development,
implementation, and evaluation of the project by
persons broadly representative of all significant
elements of the population to be served, and by
others in the community knowledgeable about the
community’s needs for family planning services.
[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10,
2000]
§ 59.6 What procedures apply to assure the
suitability of informational and educational
material?
(a) A grant under this section may be made only
upon assurance satisfactory to the Secretary that
the project shall provide for the review and
approval of informational and educational
materials developed or made available under the
project by an Advisory Committee prior to their
distribution, to assure that the materials are
suitable for the population or community to which
they are to be made available and the purposes of
title X of the Act. The project shall not disseminate
any such materials which are not approved by the
Advisory Committee.
(b) The Advisory Committee referred to in
paragraph (a) of this section shall be established as
follows:
(1) Size. The Committee shall consist of no fewer
than five but not more than nine members, except
that this provision may be waived by the Secretary
for good cause shown.
(2) Composition. The Committee shall include
individuals broadly representative (in terms of
demographic factors such as race, color, national
origin, handicapped condition, sex, and age) of the
population or community for which the materials
are intended.
(3) Function. In reviewing materials, the
Advisory Committee shall:
(i) Consider the educational and cultural
backgrounds of individuals to whom the materials
are addressed;
(ii) Consider the standards of the population or
community to be served with respect to such
materials;
(iii) Review the content of the material to assure
that the information is factually correct;
(iv) Determine whether the material is suitable
for the population or community to which is to be
made available; and
(v) Establish a written record of its
determinations.
§ 59.7 What criteria will the Department of
Health and Human Services use to decide
which family planning services projects to
fund and in what amount?
(a) Within the limits of funds available for these
purposes, the Secretary may award grants for the
establishment and operation of those projects
which will in the Department’s judgment best
promote the purposes of section 1001 of the Act,
taking into account:
(1) The number of patients, and, in particular, the
number of low-income patients to be served;
(2) The extent to which family planning services
are needed locally;
(3) The relative need of the applicant;
(4) The capacity of the applicant to make rapid
and effective use of the federal assistance;
(5) The adequacy of the applicant’s facilities and
staff;
(6) The relative availability of nonfederal
resources within the community be served and the
degree to which those resources are committed
to the project; and
(7) The degree to which the project plan
adequately provides for the requirements set forth
in these regulations.
(b) The Secretary shall determine the amount of
any award on the basis of his estimate of the sum
necessary for the performance of the project. No
grant may be made for less than 90 percent of the
project’s costs, as so estimated, unless the grant is
to be made for a project which was supported,
under section 1001, for less than 90 percent of its
costs in fiscal year 1975. In that case, the grant
shall not be for less than the percentage of costs
covered by the grant in fiscal year 1975.
(c) No grant may be made for an amount equal to
100 percent for the project’s estimated costs.
§ 59.8 How is a grant awarded?
(a) The notice of grant award specifies how long
HHS intends to support the project without
requiring the project to recompete for funds. This
period, called the project period, will usually be for
three to five years.
(b) Generally the grant will initially be for one
year and subsequent continuation awards will also
be for one year at a time. A grantee must submit a
separate application to have the support continued
for each subsequent year. Decisions regarding
continuation awards and the funding level of such
awards will be made after consideration of such
factors as the grantee’s progress and management
practices, and the availability of funds. In all cases,
continuation awards require a determination by
HHS that continued funding is in the best interest
of the government.
19
(c) Neither the approval of any application nor
the award of any grant commits or obligates the
United States in any way to make any additional,
supplemental, continuation, or other award with
respect to any approved application or portion of
an approved application.
§ 59.9 For what purpose may grant funds be
used?
Any funds granted under this subpart shall be
expended solely for the purpose for which the
funds were granted in accordance with the
approved application and budget, the regulations
of this subpart, the terms and conditions of the
award, and the applicable cost principles
prescribed in 45 CFR Part 74 or Part 92, as
applicable.
§ 59.10 What other HHS regulations apply to
grants under this subpart?
Attention is drawn to the following HHS
Department-wide regulations which apply to
grants under this subpart. These include:
37 CFR Part 401—Rights to inventions made by
nonprofit organizations and small business firms under
government grants, contracts, and cooperative
agreements
42 CFR Part 50, Subpart D—Public Health Service grant
appeals procedure
45 CFR Part 16—Procedures of the Departmental
Grant Appeals Board
45 CFR Part 74—Uniform administrative requirements
for awards and sub awards to institutions of higher
education, hospitals, other nonprofit organizations, and
commercial organizations; and certain grants and
agreements with states, local governments and Indian
tribal governments
45 CFR Part 80—Nondiscrimination under programs
receiving Federal assistance through the Department of
Health and Human Services effectuation of Title VI of
the Civil Rights Act of 1964
45 CFR Part 81—Practice and procedure for hearings
under Part 80 of this Title
45 CFR Part 84—Nondiscrimination on the basis of
handicap in programs and activities receiving or
benefitting from Federal financial assistance
45 CFR Part 91—Nondiscrimination on the basis of age
in HHS programs or activities receiving Federal
financial assistance
45 CFR Part 92—Uniform administrative requirements
for grants and cooperative agreements to state and local
governments
§ 59.11 Confidentiality.
All information as to personal facts and
circumstances obtained by the project staff about
individuals receiving services must be held
confidential and must not be disclosed without the
individual’s documented consent, except as may
be necessary to provide services to the patient or as
required by law, with appropriate safeguards for
confidentiality. Otherwise, information may be
disclosed only in summary, statistical, or other
form which does not identify particular
individuals.
§ 59.12 Additional conditions.
The Secretary may, with respect to any grant,
impose additional conditions prior to or at the time
of any award, when in the Department’s judgment
these conditions are necessary to assure or protect
advancement of the approved program, the
interests of public health, or the proper use of grant
funds.
[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10,
2000]
Subpart B [Reserved]
Subpart C—Grants for Family
Planning Service Training
AUTHORITY: Sec. 6 (c), 84 Stat. 1507, 42
U.S.C. 300a–4; sec. 6(c), 84 Stat. 1507, 42 U.S.C.
300a–1.
SOURCE: 37 FR 7093, Apr. 8, 1972, unless otherwise
noted.
§ 59.201 Applicability.
The regulations in this subpart are applicable to the
award of grants pursuant to section 1003 of the
Public Health Service Act (42 U.S.C. 300a–1) to
provide the training for personnel to carry out
family planning service programs described in
sections 1001 and 1002 of the Public Health
Service Act (42 U.S.C. 300, 300a).
§ 59.202 Definitions.
As used in this subpart:
(a) Act means the Public Health Service Act.
(b) State means one of the 50 States, the District
of Columbia, Puerto Rico, Guam, the Virgin
Islands, American Samoa, or the Trust Territory of
the Pacific Islands.
(c) Nonprofit private entity means a private
entity no part of the net earnings of which inures
or may lawfully inure, to the benefit of any private
shareholder or individual.
(d) Secretary means the Secretary of Health and
Human Services and any other officer or employee
of the Department of Health and Human Services
to whom the authority involved has been
delegated.
(e) Training means job-specific skill
development, the purpose of which is to promote
and improve the delivery of family planning
services.
20
§ 59.203 Eligibility.
(a) Eligible applicants. Any public or nonprofit
private entity located in a State is eligible to apply
for a grant under this subpart.
(b) Eligible projects. Grants pursuant to section
1003 of the Act and this subpart may be made to
eligible applicants for the purpose of providing
programs, not to exceed three months in duration,
for training family planning or other health
services delivery personnel in the skills,
knowledge, and attitudes necessary for the
effective delivery of family planning services:
Provided, That the Secretary may in particular
cases approve support of a program whose
duration is longer than three months where he
determines (1) that such program is consistent with
the purposes of this subpart and (2) that the
program’s objectives cannot be accomplished
within three months because of the unusually
complex or specialized nature of the training to be
undertaken.
[37 FR 7093, Apr. 8, 1972, as amended at 40 FR 17991,
Apr. 24, 1975]
§ 59.204 Application for a grant.
(a) An application for a grant under this subpart
shall be submitted to the Secretary at such time and
in such form and manner as the Secretary may
prescribe. 1 The application shall contain a full and
adequate description of the project and of the
manner in which the applicant intends to conduct
the project and carry out the requirements of this
subpart, and a budget and justification of the
amount of grant funds requested, and such other
pertinent information as the Secretary may require.
(b) The application shall be executed by an
individual authorized to act for the applicant and to
assume for the applicant the obligations imposed
by the regulations of this subpart and any
additional conditions of the grant.
1 Applications and instructions may be obtained from the
Program Director, Family Planning Services, at the Regional
Office of the Department of Health and Human Services for the
region in which the project is to be conducted, or the Office of
Family Planning,
Office of the Assistant Secretary for
Health, Washington, DC 20201.
(Sec. 6 (c), Public Health Service Act, 84 Stat. 1506 and
1507 (42 U.S.C. 300, 300a–1, and 300a–4))
[37 FR 7093, Apr. 8, 1972, as amended at 49 FR 38116,
Sept. 27, 1984] §
59.205 Project requirements.
An approvable application must contain each of
the following unless the Secretary determines that
the applicant has established good cause for its
omission:
(a) Assurances that:
(1) No portion of the Federal funds will be used
to train personnel for programs where abortion is a
method of family planning.
(2) No portion of the Federal funds will be used
to provide professional training to any student as
part of his education in pursuit of an academic
degree.
(3) No project personnel or trainees shall on the
grounds of sex, religion, or creed be excluded from
participation in, be denied the benefits of, or be
subjected to discrimination under the project.
(b) Provision of a methodology to assess the
particular training (e.g., skills, attitudes, or
knowledge) that prospective trainees in the area to
be served need to improve their delivery of family
planning services.
(c) Provision of a methodology to define the
objectives of the training program in light of the
particular needs of trainees defined pursuant to
paragraph (b) of this section.
(d) Provision of a method for development of the
training curriculum and any attendant training
materials and resources.
(e) Provision of a method for implementation of
the needed training.
(f) Provision of an evaluation methodology,
including the manner in which such methodology
will be employed, to measure the achievement of
the objectives of the training program.
(g) Provision of a method and criteria by which
trainees will be selected.
§ 59.206 Evaluation and grant award.
(a) Within the limits of funds available for such
purpose, the Secretary may award grants to assist
in the establishment and operation of those projects
which will in his judgment best promote the
purposes of section 1003 of the Act, taking into
account:
(1) The extent to which a training program will
increase the delivery of services to people,
particularly low-income groups, with a high
percentage of unmet need for family planning
services;
(2) The extent to which the training program
promises to fulfill the family planning services
delivery needs of the area to be served, which may
include, among other things:
(i) Development of a capability within family
planning service projects to provide pre- and in-
service training to their own staffs;
21
(ii) Improvement of the family planning services
delivery skills of family planning and health
services personnel;
(iii) Improvement in the utilization and career
development of paraprofessional and paramedical
manpower in family planning services;
(iv) Expansion of family planning services,
particularly in rural areas, through new or
improved approaches to program planning and
deployment of resources;
(3) The capacity of the applicant to make rapid
and effective use of such assistance;
(4) The administrative and management
capability and competence of the applicant;
(5) The competence of the project staff in
relation to the services to be provided; and
(6) The degree to which the project plan
adequately provides for the requirements set forth
in § 59.205.
(b) The amount of any award shall be determined
by the Secretary on the basis of his estimate of the
sum necessary for all or a designated portion of
direct project costs plus an additional amount for
indirect costs, if any, which
will be calculated by the Secretary either: (1) On
the basis of his estimate of the actual indirect costs
reasonably related to the project, or (2) on the basis
of a percentage of all, or a portion of, the estimated
direct costs of the project when there are
reasonable assurances that the use of such
percentage will not exceed the approximate actual
indirect costs. Such award may include an
estimated provisional amount for indirect costs or
for designated direct costs (such as travel or supply
costs) subject to upward (within the limits of
available funds) as well as downward adjustments
to actual costs when the amount properly expended
by the grantee for provisional items has been
determined by the Secretary.
(c) Allowability of costs shall be in conformance
with the applicable cost principles prescribed by
Subpart Q of 35 CFR part 74.
(d) All grant awards shall be in writing, shall set
forth the amount of funds granted and the period
for which support is recommended.
(e) Neither the approval of any project nor any
grant award shall commit or obligate the United
States in any way to make any additional,
supplemental, continuation, or other award with
respect to any approved project or portion thereof.
For continuation support, grantee must make
separate application annually at such times and in
such form as the Secretary may direct.
[37 FR 7093, Apr. 8, 1972, as amended at 38 FR
26199, Sept. 19, 1973]
§ 59.207 Payments.
The Secretary shall from time to time make
payments to a grantee of all or a portion of any
grant award, either in advance or by way of
reimbursement for expenses incurred or to be
incurred in the performance of the project to the
extent he determines such payments necessary to
promote prompt initiation and advancement of the
approved project.
§ 59.208 Use of project funds.
(a) Any funds granted pursuant to this subpart as
well as other funds to be used in performance of
the approved project shall be expended solely for
carrying out the approved project in accordance
with the statute, the regulations of this subpart, the
terms and conditions of the award, and, except as
may otherwise be provided in this subpart, the
applicable cost principles prescribed by subpart Q
of 45 CFR part 74.
(b) Prior approval by the Secretary of revision of
the budget and project plan is required whenever
there is to be a significant change in the scope or
nature of project activities.
(c) The Secretary may approve the payment of
grant funds to trainees for:
(1) Return travel to the trainee’s point of origin.
(2) Per Diem during the training program, and
during travel to and from the program, at the
prevailing institutional or governmental rate,
whichever is lower.
[37 FR 7093, Apr. 8, 1972, as amended at 38 FR
26199, Sept. 19, 1973]
§ 59.209 Civil rights.
Attention is called to the requirements of Title VI
of the Civil Rights Act of 1964 (78 Stat. 252, 42
U.S.C. 2000d et seq.) and in particular section 601
of such Act which provides that no person in the
United States shall, on the grounds of race, color,
or national origin be excluded from participation
in, be denied the benefits of, or be subjected to
discrimination under any program or activity
receiving Federal financial assistance. A
regulation implementing such title VI, which
applies to grants made under this part, has been
issued by the Secretary of Health and Human
Services with the approval of the President (45
CFR part 80).
§ 59.210 Inventions or discoveries.
Any grant award pursuant to § 59.206 is subject
to the regulations of the Department of Health and
Human Services as set forth in 45 CFR parts 6 and
8, as amended. Such regulations shall apply to any
activity for which grant funds are in fact used
22
whether within the scope of the project as approved
or otherwise. Appropriate measures shall be taken
by the grantee a nd by the Secretary to assure that
no contracts, assignments or other arrangements
inconsistent with the grant obligation are
continued or entered into and that all personnel
involved in the supported activity are aware of and
comply with such obligations. Laboratory notes,
related technical data, and information pertaining
to inventions and discoveries shall be maintained
for such periods, and filed with or otherwise made
available to the Secretary, or those he may
designate at such times and in such manner, as he
may determine necessary to carry out such
Department regulations.
§ 59.211 Publications and copyright.
Except as may otherwise be provided under the
terms and conditions of the award, the grantee may
copyright without prior approval any publications,
films or similar materials developed
or resulting from a project supported by a grant
under this part, subject, however, to a royalty-free,
nonexclusive, and irrevocable license or right in
the Government to reproduce, translate, publish,
use, disseminate, and dispose of such materials and
to authorize others to do so.
§ 59.212 Grantee accountability.
(a) Accounting for grant award payments.
All payments made by the Secretary shall be
recorded by the grantee in accounting records
separate from the records of all other grant funds,
including funds derived from other grant awards.
With respect to each approved project the grantee
shall account for the sum total of all amounts paid
by presenting or otherwise making available
evidence satisfactory to the Secretary of
expenditures for direct and indirect costs meeting
the requirements of this part: Provided, however,
That when the amount awarded for indirect costs
was based on a predetermined fixed-percentage of
estimated direct costs, the amount allowed for
indirect costs shall be computed on the basis of
such predetermined fixed-percentage rates applied
to the total, or a selected element thereof, of the
reimbursable direct costs incurred.
(b) [Reserved]
(c) Accounting for grant-related income—(1)
Interest. Pursuant to section 203 of the
Intergovernmental Cooperation Act of 1968 (42
U.S.C. 4213), a State will not be held accountable
for interest earned on grant funds, pending their
disbursement for grant purposes. A State, as
defined in section 102 of the Intergovernmental
Cooperation Act, means any one of the several
States, the District of Columbia, Puerto Rico, any
territory or possession of the United States, or any
agency or instrumentality of a State, but does not
include the governments of the political
subdivisions of the State. All grantees other than a
State, as defined in this subsection, must return all
interest earned on grant funds to the Federal
Government.
(d)Grant closeout—(1) Date of final accounting.
A grantee shall render, with respect to each
approved project, a full account, as provided
herein, as of the date of the termination of grant
support. The Secretary may require other special
and periodic accounting.
(2) Final settlement. There shall be payable to the
Federal Government as final settlement with
respect to each approved project the total sum of:
(i) Any amount not accounted for pursuant to
paragraph (a) of this section;
(ii) Any credits for earned interest pursuant to
paragraph (c) (1) of this section;
(iii) Any other amounts due pursuant to subparts
F, M, and O of 45 CFR part 74.
Such total sum shall constitute a debt owed by the
grantee to the Federal Government and shall be
recovered from the grantee or its successors or
assignees by setoff or other action as provided by
law.
[36 FR 18465, Sept. 15, 1971, as amended at 38
FR 26199, Sept. 19, 1973]
§ 59.213 [Reserved]
§ 59.214 Additional conditions.
The Secretary may with respect to any grant
award impose additional conditions prior to or at
the time of any award when in his judgment such
conditions are necessary to assure or protect
advancement of the approved project, the interests
of public health, or the conservation of grant funds.
§ 59.215 Applicability of 45 CFR part 74.
The provisions of 45 CFR part 74, establishing
uniform administrative requirements and cost
principles, shall apply to all grants under this
subpart to State and local governments as those
terms are defined in subpart A of that part 74. The
relevant provisions of the following subparts of
part 74 shall also apply to grants to all other grantee
organizations under this subpart.
45 CFR PART 74
Subpart:
A General.
B Cash Depositories.
C Bonding and Insurance.
D Retention and Custodial Requirements for
Records.
F Grant-Related Income.
23
G Matching and Cost Sharing.
K Grant Payment Requirements.
L Budget Revision Procedures.
M Grant Closeout, Suspension, and Termination.
O Property.
Q Cost Principles.
[38 FR 26199, Sept. 19, 1973]
PART 59a—NATIONAL LIBRARY OF
MEDICINE GRANTS
S
ubpart A—Grants for Establishing,
Expanding, and Improving Basic Resources
S
ec.
59a.1 Programs to which these regulations apply.
59a.2 Definitions.
59a.3 Who is eligible for a grant?
59a.4 How are grant applications evaluated?
59a.5 Awards.
59a.6 How may funds or materials be used?
59a.7 Other HHS regulations that apply.
S
ubpart B—Establishment of Regional
Medical Libraries
59a
.11 Programs to which these regulations
apply.
59a.12 Definitions.
59a.13 Who is eligible for a grant?
59a.14 How to apply.
59a.15 Awards.
59a.16 What other conditions apply?
59a.17 Other HHS regulations that apply.
SOURCE: 56 FR 29189, June 26, 1991, unless
otherwise noted.
Subpart A—Grants for Establishing,
Expanding, and Improving Basic Resources
AUTHORITY: 42 U.S.C. 286b–2, 286b–5.
§ 59a.1 Programs to which these regulations
apply.
(a) The regulations of this subpart apply to grants
of funds, materials, or both, for establishing,
expanding, and improving basic medical library
resources as authorized by section 474 of the Act
(42 U.S.C. 286b–5).
(b) This subpart also applies to cooperativ
e
agreements awarded for this purpose. In these
circumstances, references to ‘‘grant(s)’’ shall
include ‘‘cooperative agreements(s).’’
§ 5
9a.2 Definitions.
Undefined terms have the same meaning as
provided in the Act. As used in this subpart:
Act means the Public Health Service Act, as
amended (42 U.S.C. 201 et seq.).
Project period—See § 59a.5(c).
Related instrumentality means a public or private
institution, organization, or agency, other than a
medical library, whose primary function is the
acquisition, preservation, dissemination, and/ or
processing of information relating to the health
sciences.
Secretary means the Secretary of Health and
Human Services and any other official of the
Department of Health and Human Services to
whom the authority involved is delegated.
24
Title X Federal Program Guidelines, Guidance and
Internet Resources
Program Guidelines, Tools and Documents
This Internet site provides access to Office of Population Affairs documents including program
guidelines, resource documents, contacts to regional agencies, and Compliance Standards for
Family Planning Services Projects. The documents listed below are available from the OPA
website: http://www.hhs.gov/opa/title-x-family-planning/
Title X Policies
Legislative Mandates
http://www.hhs.gov/opa/title-x-family-planning/about-title-x-grants/legislative-mandates/index.html#
Statute and Regulations
http://www.hhs.gov/opa/title-x-family-planning/about-title-x-grants/statutes-and-regulations/index.html
Program Guidelines:
Program Requirements for Title X Funded Family Planning Projects
http://www.hhs.gov/opa/sites/default/files/ogc-cleared-final-april.pdf
Providing Quality Family Planning Services (QFP): Recommendations of CDC and the
U.S. Office of Population Affairs
http://www.cdc.gov/mmwr/pdf/rr/rr6304.pdf
Program Priorities and Key Issues
http://www.hhs.gov/opa/title-x-family-planning/title-x-policies/program-priorities/
Sterilization of Persons in Federally Assisted Family Planning Projects Regulations
http://www.ecfr.gov/cgi-bin/text-
idx?SID=abe9d67cd40497fdfc6af386c63460ee&mc=true&node=sp42.1.50.b&rgn=div6
Provision of Abortion-Related Services in Family Planning Projects-Statutory Requirement
http://www.gpo.gov/fdsys/pkg/FR-2000-07-03/pdf/00-16759.pdf
Standards of Compliance for Abortion-Related Services in Family Planning Services Projects-Final rules
http://www.gpo.gov/fdsys/pkg/FR-2000-07-03/pdf/00-16758.pdf
Family Planning Annual Reports
http://www.hhs.gov/opa/title-x-family-planning/research-and-data/fp-annual-reports/
25
Program Priorities, Key Issues, Legislative Mandates
2017 Program Priorities
1. Assuring the delivery of quality family planning and related preventive health services,
with priority for services to individuals from low-income families. This includes
ensuring that grantees have the capacity to support implementation (e.g., through staff
training and related systems changes) of the Title X program guidelines throughout their
Title X services projects, and that project staff have received training on Title X
program requirements;
2. Assessing clients’ reproductive life plan/reproductive intentions as part of determining
the need for family planning services, and providing preconception services as
stipulated in QFP;
3. Providing access to a broad range of acceptable and effective family planning methods
and related preventive health services in accordance with the Title X program
requirements and the 2014 QFP. These services include, but are not limited to,
contraceptive services, pregnancy testing and counseling, services to help clients
achieve pregnancy, basic infertility services, STD services, preconception health
services, and breast and cervical cancer screening. The broad range of services does not
include abortion as a method of family planning;
4. Ensuring that all clients receive contraceptive and other services in a voluntary, client-
centered and non-coercive manner in accordance with QFP and Title X requirements.
5. Identifying individuals, families, and communities in need, but not currently receiving
family planning services, through outreach to hard-to-reach and/or vulnerable
populations, and partnering with other community-based health and social services
providers that provide needed services; and
6. Demonstrating that the project’s infrastructure and management practices ensure
sustainability of family planning and reproductive health services delivery throughout
the proposed service area including:
o Incorporation of certified Electronic Health Record (EHR) systems that have the
ability to capture family planning data within structured fields;
o Evidence of contracts with insurance plans and systems for third party billing as
well as the ability to facilitate the enrollment of clients into private insurance and
Medicaid, optimally onsite; and to report on numbers of clients assisted and
enrolled; and
o Addressing the comprehensive health care needs of clients through formal, robust
linkages or integration with comprehensive primary care providers.
26
2017 Key Issues
In addition to program priorities, the following key issues have implications for Title X Services
projects and should be considered in developing the project plan:
1. Incorporation of the 2014 Title X Program Guidelines throughout the proposed
service area as demonstrated by written clinical protocols that are in accordance
with Title X Requirements and QFP.
2. Efficiency and effectiveness in program management and operations;
3. Patient access to a broad range of contraceptive options, including long acting
reversible contraceptives (LARC), other pharmaceuticals, and laboratory tests
preferably on site;
4. Use of performance measures to regularly perform quality assurance and quality
improvement activities, including the use of measures to monitor contraceptive use;
5. Establishment of formal linkages and documented partnerships with comprehensive
primary care providers, HIV care and treatment providers, and mental health, drug
and alcohol treatment providers;
6. Incorporation of the National HIV/AIDS Strategy (NHAS) and CDC’s "Revised
Recommendations for HIV Testing of Adults, Adolescents and Pregnant Women in
Health Care Settings;" and
7. Efficient and streamlined electronic data collection [such as for the Family
Planning Annual Report (FPAR)], reporting and analysis for internal use in
monitoring staff or program performance, program efficiency, and staff
productivity in order to improve the quality and delivery of family planning
services;
Legislative Mandates
The following legislative mandates have been part of the Title X appropriations language for each
of the last several years. Title X family planning services projects should include administrative,
clinical, counseling, and referral services necessary to ensure adherence to these requirements.
• None of the funds appropriated in this Act may be made available to any entity
under Title X of the Public Health Service 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 and that it provides counseling to minors
on how to resist attempts to coerce minors into engaging in sexual activities.
• Notwithstanding any other provision of law, no provider of services under Title X
of the Public Health Service Act shall be exempt from any State law requiring
notification or the reporting of child abuse, child molestation, sexual abuse, rape, or
incest.
27
Title X the National Family Planning Program
For more than 40 years, Title X family planning centers have provided high quality and cost-
effective family planning and related preventive health services for low-income women and
men. Family planning centers play a critical role in ensuring access to voluntary family
planning information and services for their clients based on their ability to pay.
Family planning centers offer a broad range of FDA-approved contraceptive methods and
related counseling; as well as breast and cervical cancer screening; pregnancy testing and
counseling; screening and treatment for sexually transmitted infections (STIs); HIV testing;
and other patient education and referrals
1
.
Title X Providers
The U.S. Department of Health and Human Services’ Office of Population Affairs (OPA)
oversees the Title X program. OPA funds a network of 4,400 family planning centers which
serve about five million clients a year
2
. Services are provided through state, county, and local
health departments; community health centers; Planned Parenthood centers; and hospital-
based, school-based, faith-based, other private nonprofits.
Title X staffs are specially trained to meet the contraceptive needs of individuals with limited
English proficiency, teenagers, and those confronting complex medical and personal issues
such as substance abuse, disability, homelessness or interpersonal and domestic violence.
The Title X Mission
Title X assists individuals and couples in planning and spacing births, contributing to positive
birth outcomes and improved health for women and infants.
In addition to clinical services, Title X also funds the following program supports aimed at
improving the quality of family planning services:
• Training for family planning clinic personnel through five national training
programs that focus on clinical training; service delivery; management and systems
improvement; coordination and strategic initiatives; and quality
assurance/improvement and evaluation
• Family planning research and evaluation to improve Title X service delivery and
inform the broader reproductive health care field
• Information dissemination and community-based education and outreach
Cost Effectiveness of Family Planning
Title X provides significant cost savings to taxpayers. In 2010, every public dollar spent on
contraceptive services yielded an estimated $5.68 in savings that would have been spent on
Medicaid costs related to pregnancy care and delivery and to infants in their first year of life
3
.
Significantly, this figure does not include savings realized from the prevention and treatment
of STIs and avoiding and detecting reproductive cancers. These calculations also do not
measure the broader health, social or economic benefits of enabling women to time or prepare
for their pregnancies
3
.
28
OPA Program Policy Notice Series
In June 2014, OPA initiated the Program Policy Notice (PPN) series that replaces the recently
retired OPA Program Instruction Series. OPA Program Policy Notices will be issued periodically to
define and/or clarify policies or procedures that grantees funded under the Title X Family Planning
Program must follow. OPA Program Policy Notices are listed here most recent first.
_____________________________________________________________________________
Clarification regarding “How Title X Grantees may remain in compliance when integrating
services with HRSA Health Center Program Grantees and look-alikes”
Integrating with Primary Care Providers
OPA Program Policy Notice 2016-11 Release Date: November 22, 2016
I. Purpose
The purpose of this Program Policy Notice (PPN) is to clarify how Title X grantees may remain in
compliance with Program Requirements for Title X Funded Family Planning Projects when
integrating services with Health Resources & Services Administration (HRSA) Health Center
Program grantees and look-alikes (i.e., health centers that receive funding under Section 330 of the
Public Health Service Act, which authorizes the Health Center Program, as well as those that have
been determined to meet Section 330 requirements but do not receive grant funding under that
program). This PPN applies only to integrated settings, and not to settings in which only Health
Center Program services are provided. We address three issues commonly faced by integrated Title
X and HRSA-funded health center providers:
1) How to bill clients receiving Title X family planning services in compliance with Title X
and Health Center Program Sliding Fee Discount Schedules and billing guidelines;
2) How to report data to the Family Planning Annual Report (FPAR) and to the Uniform Data
System (UDS) appropriately; and,
3) How to preserve Title X client confidentiality when billing for services provided.
II. Background
In 2014, the Office of Population Affairs (OPA) released new Title X program guidelines consisting
of two parts:
1) Program Requirements for Title X Funded Family Planning Projects (Title X Program
Requirements); and,
2) Providing Quality Family Planning Services: Recommendations of CDC and the U.S.
Office of Population Affairs (QFP).
Title X Program Requirements align closely with the Title X statute and family planning services
project implementing regulations (42 CFR part 59, subpart A), as well as other applicable federal
statutes, regulations, and policies. This PPN is intended to help Title X grantees address integrated
care settings with regard to Title X Program Requirements.
III. Clarification
29
This section provides clarification for some of the most common issues facing Title X Family
Planning (FP) providers when integrating with primary care organizations and suggests sample
strategies to overcome these issues. Endnotes are provided for reference to the applicable section(s)
of the Title X and HRSA Health Center Program Requirements aligned with each strategy.
Issue 1: Nominal Charge and Sliding Fee Discount Schedules (SFDS)
Strategy
The HRSA Health Center Program and the OPA Title X Program have unique Sliding Fee Discount
Schedule (SFDS) program requirements, which include having differing upper limits. HRSA’s
policies, currently contained in Policy Information Notice (PIN) 2014-02, allow health centers to
accommodate the further discounting of services as required by Title X regulations. Title X agencies
(or providers) that are integrated with or receive funding from the HRSA Health Center Program may
have dual fee discount schedules: one schedule that ranges from 101% to 200% of the Federal Poverty
Level (FPL) for all health center services, and one schedule that ranges from 101% to 250% FPL for
clients receiving only Title X family planning services directly related to preventing or achieving
pregnancy, and as defined in their approved Title X project.
Title X agencies and providers may consult with the health center if they have additional questions
regarding implementing discounting schedules that comply with Title X and Health Center Program
requirements, which may result in the health center needing to consult their HRSA Health Center
Program Project Officer.
To decide which SFDS to use, the health center should determine whether a client is receiving only
Title X family planning services (Title X family planning services are defined by the service
contract between the Title X grantee and health center) or health center services in addition to Title
X family planning services within the same visit.
The following guidance applies specifically to clients who receive only Title X family planning
services that are directly related to preventing or achieving pregnancy:
• Clients receiving only Title X family planning services with family incomes at or below 100%
of the FPL must not be charged for services received. In order to comply with Title X regulations,
any nominal fee typically collected by a HRSA health center program grantee or look-alike would
not be charged to the client receiving only Title X family planning services.
i
• Clients receiving only Title X family planning services with family incomes that are between
101% FPL and 250% FPL must be charged in accordance with a specific Title X SFDS based
on the client’s ability to pay. Any differences between charges based on applying the Title X
SFDS and the health center’s discounting schedule could be allocated to Title X grant funds.
This allocation is aligned with the guidance provided in HRSA’s PIN 2014-02, as discussed
above. This PIN states that program grantees, “may receive or have access to other funding
sources (e.g., Federal, State, local, or private funds) that contain terms and conditions for
reducing patient costs for specific services. These terms and conditions may apply to patients
over 200 percent of the FPG [Federal Poverty Guidelines]. In such cases, it is permissible for
a health center to allocate a portion (or all) of this patient’s charge to this grant or subsidy
funding source.”
ii
30
• Note that un-emancipated minors who receive confidential Title X family planning services
must be billed according to the income of the minor.
iii
The following guidance applies specifically to clients who receive health center services in addition
to Title X family planning services within the same visit:
• For clients receiving health center services in addition to Title X family planning services, as
defined above, within the same visit, the health center or look-alike may utilize its health center
discounting schedule (which ranges from 101% to 200% FPL) including collecting one nominal
fee for health center services provided to clients with family incomes at or below 100% FPL.
Issue 2: Fulfilling Data Reporting Requirements
Strategy
To comply with mandatory program reporting requirements for both the Title X and HRSA Health
Center Program, health centers that are integrated with Title X funded agencies must provide data on
services provided that are relevant to either or both through FPAR and UDS, as appropriate. In cases
where a data element is applicable to both FPAR and UDS, reporting such data to each report does
not result in “double” credit for services provided; rather, it ensures that both Title X and HRSA
receive accurate information on services provided to clients during the given reporting period.
Further instructions on how a family planning “user” is defined can be found in the FPAR Forms &
Instructions guidance document.
Issue 3: Sliding Fee Discount Schedule eligibility for individuals seeking confidential services
Strategy
For individuals requesting that Title X family planning services provided to them are confidential
(i.e., they do not want their information disclosed in any way, including for third-party billing), the
provider should ensure that appropriate measures are in place to protect the client’s information,
beyond HIPAA privacy assurances.
iv
Providers may not bill third-party payers for services in
such cases where confidentiality cannot be assured (e.g., a payer does not suppress Explanation of
Benefits documents and does not remove such information from claims history and other
documents accessible to the policy holder). Providers may request payment from clients at the time
of the visit for any confidential services provided that cannot be disclosed to third-party payers, as
long as the provider uses the appropriate SFDS. Inability to pay, however, cannot be a barrier to
services.
v
Providers may bill third-party payers for services that the client identifies as non-
confidential.
Endnotes
i
Section 8.4 of the Title X Program Requirements contains information related to charges, billing,
and collections. The program requirements in section 8.4 most relevant to charging clients at or
below 100% of the FPL, between 101% and 250% of the FPL, and above 250% of the FPL, are as
follows:
Title X Program Requirement 8.4.1. Clients whose documented income is at or below 100% of the
Federal Poverty Level (FPL) must not be charged, although projects must bill all third parties
31
authorized or legally obligated to pay for services (Section 1006(c)(2), PHS Act; 42 CFR
59.5(a)(7)).
Within the parameters set out by the Title X statute and program requirements, Title X grantees
have a large measure of discretion in determining the extent of income verification activity that
they believe is appropriate for their client population. Although not required to do so, grantees that
have lawful access to other valid means of income verification because of the client’s participation
in another program may use those data rather than re-verify income or rely solely on clients self-
report.
Title X Program Requirement 8.4.2. A schedule of discounts, based on ability to pay, is required
for individuals with family incomes between 101% and 250% of the FPL (42 CFR 59.5(a)(8)).
Title X Program Requirement 8.4.3. Fees must be waived for individuals with family incomes
above 100% of the FPL who, as determined by the service site project director, are unable, for
good cause, to pay for family planning services (42 CFR 59.2).
Title X Program Requirement 8.4.4. For persons from families whose income exceeds 250% of the
FPL, charges must be made in accordance with a schedule of fees designed to recover the
reasonable cost of providing services. (42 CFR 59.5(a)(8)).
ii
HRSA Policy Information Notice PIN 2014-02, “Sliding Fee Discount and Related Billing and
Collections Program Requirements.” Individuals and families with annual incomes above 200
percent of the FPG are not eligible for sliding fee discounts. However, health centers may receive
or have access to other funding sources (e.g., Federal, State, local, or private funds) that contain
terms or conditions for reducing patient costs for specific services. These terms and conditions may
apply to patients over 200 percent of the FPG. In such cases, it is permissible for a health center to
allocate a portion (or all) of this patient’s charge to this grant or subsidy funding source.
iii
Title X Program Requirement 8.4.5. Eligibility for discounts for un-emancipated minors who
receive confidential services must be based on the income of the minor (42 CFR 59.2).
iv
Title X Program Requirement 8.4.8. Reasonable efforts to collect charges without jeopardizing
client confidentiality must be made.
HRSA PIN 2014-02. Patient privacy and confidentiality must be protected throughout the (SFDS
eligibility determination) process. The act of billing and collecting from patients should be
conducted in an efficient, respectful and culturally appropriate manner, assuring that procedures
do not present a barrier to care and patient privacy and confidentiality are protected throughout
the process.
v
Title X Program Requirement 8.4.3, repeated. Fees must be waived for individuals with family
incomes above 100% of the FPL who, as determined by the service site project director, are
unable, for good cause, to pay for family planning services (42 CFR 59.2).
__________________________________________________________________________
32
Clarification regarding “Program Requirements for
Title X Family Planning Projects”
Confidential Services to Adolescents
OPA Program Policy Notice 2014-01 Release Date: June 5, 2014
I. Purpose
The purpose of this Program Policy Notice (PPN) is to provide Title X grantees with information to
clarify some specific requirements included in the newly released “Program requirements for Title
X-Funded Family Planning Projects Version 1.0-April 2014.”
II. Background
On April 25, 2014, the Office of Population Affairs (OPA), which administers the Title X Family
Planning Program, released new Title X Family Planning Guidelines consisting of two parts: 1)
Program requirements for Title X Family Planning Projects (hereafter referred to as Title X
Program Requirements), and 2) Providing Quality Family Planning Services: Recommendations of
CDC and the U.S. Office of Population Affairs.
The Title X Program Requirements document closely aligns with the various requirements
applicable to the Title X Program as set out in the Title X statute and implementing regulations (42
CFR part 59, subpart A), and other applicable Federal statutes, regulations, and policies. The
requirement that this Program Policy Notice addresses is confidential services to adolescents.
Requirements regarding confidential services for individuals regardless of age are stipulated in
Title X regulations at 42 CFR § 59.5(a)(4) and § 59.11, and are repeated in the Title X Program
Requirements in sections 9.3 and 10.
III. Clarification
It continues to be the case that Title X projects may not require written consent of parents of
guardians for the provision of services to minors. Nor can any Title x project staff notify a parent or
guardian before or after a minor has requested and/or received Title X family planning services.
Title X projects, however, must comply with legislative mandates that require them to encourage
family participation in the decision of minors to seek family planning services, and provide
counseling to minors how to resist attempts to coerce minors into engaging in sexual activities. In
addition, all Title X providers must comply with State laws requiring notification or the reporting
of child abuse, child molestation, sexual abuse, rape, or incest.
Susan B. Moskowsky, MS, WHNP-BC
Acting Director, Office of Population Affairs
33
FPAR: Family Planning Annual Reporting
Requirements and Instructions
Family Planning Annual Report
This annual reporting requirement is for family planning services delivery projects authorized and
funded under Title X of the Public Health Service Act, 42 United States Code [USC] 300).
Annual submission of the Family Planning Annual Report (FPAR) is required of all Title X family
planning services grantees for purposes of monitoring and reporting program performance. FPAR
data are presented in summary form, which protects the confidentiality of individuals who receive
Title X-funded services.
The FPAR is the only source of annual, uniform reporting by all Title X family planning services
grantees. It provides consistent, national-level data on the Title X Family Planning Program and its
users.
Information from the FPAR is important to OPA for several reasons. FPAR data are used to
monitor compliance with statutory requirements, regulations, and guidance provided in the
Program Guidelines, including:
• Monitoring compliance with legislative mandates, such as giving priority in the
provision of services to low-income persons, and
• Ensuring that Title X grantees and their subcontractors provide a broad range of
family planning methods and services.
OPA uses FPAR data to comply with accountability and federal performance requirements for Title
X family planning funds as required by the 1993 Government Performance and Results Act
(GPRA). Current GPRA performance goals for the Title X Family Planning Program include
priority in the provision of family planning services to low-income individuals, access to and
utilization of cervical and breast cancer screening, and access to on-site HIV testing.
OPA relies on FPAR data to guide strategic and financial planning, to monitor performance, and to
respond to inquiries from policymakers and Congress about the program. The FPAR allows OPA to
assemble program data about the characteristics of the population served, utilization of services,
composition of revenues, and program impact. FPAR data are a basis for objective grant reviews,
program evaluation, and assessment of program technical needs. http://www.hhs.gov/opa/title-x-
family-planning/research-and-data/fp-annual-reports/
The federal FPAR forms and instructions are available at the following link:
https://www.hhs.gov/opa/sites/default/files/fpar-forms-instructions-reissued-oct-2016.pdf
34
Title X Resources and Links
Office of Family Planning
Office of Population Affairs
Office of Public Health and Science
US Department of Health and Human Services
4350 East West Highway, Suite 200
Bethesda, MD 20817
(301)594-4008
www.hhs.gov/opa
Office of Population Affairs Publications
Providing Information and Education to the public, as well as to Title X grantees, is an important
component of the Title X Program. Publications can be accessed and downloaded from the OPA
website under Pregnancy Prevention and Reproductive Health. www.hhs.gov/opa.
Department of Health and Human Services Websites
http://www.hhs.gov/ophs - Website provides helpful websites:
OSHA Regulations National Vaccine Program Office
Office of Population Affairs Office of Pharmacy Affairs- 340B Program
Healthy People 2020 Office of Disease Prevention & Health Promotion
Office of HIV/AIDS Grant Opportunities
Zika Virus OPA Website National Family Planning Training Centers
Office of the Surgeon General Zika Virus CDC Site
Office of Minority Health President’s Council on Physical Fitness & Sports
Office of Research Integrity National Health Information Center
Administrative Regulations that apply to Title X Grants
HHS Grants Policy Statement 2007: The Department of Health and Human Services Grants
Policy Statement summarizes the general terms and conditions of HHS grant awards which apply to
Title X grants. http://www.ahrq.gov/funding/policies/hhspolicy/index.html
Links to HHS Department regulations that apply to Title X grants:
35
• 2 CFR Chapter I, Chapter II, Part 200: Uniform administrative requirements, Cost
Principles, and Audit Requirements for Federal Awards; Final Rule. Federal Register
December 26, 2013. This guidance streamlined requirements and supersedes administrative
requirements (A-110 and A-102), cost principles (A-21, A-87, and A-122), audit
requirements (A-50, A-89, and A-133), and HHS regulations (45 CFR Parts 74 and 92).
https://www.gpo.gov/fdsys/pkg/FR-2013-12-26/pdf/2013-30465.pdf
• 45 CFR Part 75: Uniform Administrative Requirements, Cost Principles, and Audit
Requirements for HHS Awards and is available as an electronic document:
https://www.law.cornell.edu/cfr/text/45/part-75/subpart-F
• 45 CFR Part 80: Nondiscrimination under programs receiving Federal assistance through
HHS effectuation of Title VI of the Civil Rights Act of 1964
http://www.law.cornell.edu/cfr/text/45/part-80
• 45 CFR Part 81: Practice and procedure for hearings under Part 80 of this Title
http://www.law.cornell.edu/cfr/text/45/part-81
• 45 CFR Part 84: Nondiscrimination on the basis of disability in programs and activities
receiving or benefitting from Federal financial assistance
http://www.law.cornell.edu/cfr/text/45/part-84
• 45 CFR Part 91: Nondiscrimination on the basis of age in HHS programs or activities
receiving Federal financial assistance http://www.law.cornell.edu/cfr/text/45/part-91
• 37 CFR Part 401: Rights to inventions made by nonprofit organizations and small business
firms under government grants, contracts, and cooperative agreements
http://www.law.cornell.edu/cfr/text/37/part-401
• 42 CFR Part 50, Subpart D: Public Health Service grant appeals procedure
http://www.law.cornell.edu/cfr/text/42/part-50/subpart-D
• 45 CFR Part 16: Procedures of the Departmental Grant Appeals Board
http://www.law.cornell.edu/cfr/text/45/part-16
• 45 CFR Part 100: Intergovernmental Review of Department of Health and Human Services
Programs and Activities http://www.law.cornell.edu/cfr/text/45/part-100
Civil Rights Act of 1964
The Civil Rights Act of 1964 enforces the constitutional right to vote and provides relief against
discrimination in public accommodations. It authorizes the Attorney General to protect
constitutional rights in public facilities and public education, to protect civil rights, to prevent
36
discrimination in federally assisted programs, and to establish a Commission on Equal Employment
Opportunity.
Title IV of the Civil Rights Act of 1964 provides protections against discrimination under programs
receiving Federal assistance through HHS. The following websites provide information relevant to
family planning programs.
Overview: http://www.eeoc.gov/eeoc/
Protections of Employees: http://www.eeoc.gov/employers/index.cfm
Laws and Guidance: https://www.eeoc.gov/laws/index.cfm
Non-Discrimination on the Basis of Handicap in
Programs Receiving Federal Financial Assistance
(45CFR Part 84)
The purpose of 45 CFR Part 84 is to assure implementation of section 504 of the Rehabilitation Act
of 1973, which is designed to eliminate discrimination on the basis of handicap in any program or
activity receiving Federal financial assistance. It applies to each recipient of Federal financial
assistance from the Department of Health and Human Services and to the program or activity that
receives such assistance, including Title X projects. It is intended to assure that no qualified
handicapped person, on the basis of handicap, be excluded from participation in, be denied the
benefits of, or otherwise be subjected to discrimination under any program or activity which
receives Federal financial assistance. Facilities and services must be available to accommodate
persons with disabilities.
http://www.law.cornell.edu/cfr/text/45/part-84
http://www.hhs.gov/ocr/civilrights/understanding/disability/laws/disabilitylawsregandguidancemp.html
Occupational Safety and Health Standards
29 CFR Part 1910 Subpart E
The Occupational Safety & Health Administration (OSHA) defines standards for the health and
safety of employees. 29 CFR Part 1910, Subpart E provides guidance for employers regarding
emergency planning.
https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10113&p_table=standards
https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10114
37
Health Insurance Portability and Accountability Act of
1996 (HIPAA)
Many aspects of this law impact Michigan Department of Health and Human Services and its sub-
recipient agencies. Much information is available on implementation and compliance with the
Health Insurance Portability and Accountability Act of 1996 (HIPAA.) The websites listed below
will provide comprehensive information. The following is a summary of the HIPPA statute:
Administrative Simplification
To improve the efficiency and effectiveness of the health care system, the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, included Administrative
Simplification provisions that required HHS to adopt national standards for electronic health care
transactions and code sets, unique health identifiers, and security. At the same time, Congress
recognized that advances in electronic technology could erode the privacy of health information.
Consequently, Congress incorporated into HIPAA provisions that mandated the adoption of Federal
privacy protections for individually identifiable health information.
HHS published a final Privacy Rule in December 2000, which was later modified in August 2002.
This Rule set national standards for the protection of individually identifiable health information by
three types of covered entities: health plans, health care clearinghouses, and health care providers
who conduct the standard health care transactions electronically. Compliance with the Privacy
Rule was required as of April 14, 2003 (April 14, 2004, for small health plans).
HHS published a final Security Rule in February 2003. This Rule sets national standards for
protecting the confidentiality, integrity, and availability of electronic protected health
information. Compliance with the Security Rule was required as of April 20, 2005 (April 20, 2006
for small health plans). All of the HIPAA Administrative Simplification Rules are located at 45
CFR Parts 160, 162, and 164.
The Privacy Rule
The Office of Civil Rights administers and enforces the HIPAA Privacy Rule which establishes
national standards to protect individuals’ medical records and other personal health information and
applies to health plans, health care clearinghouses, and those health care providers that conduct
certain health care transactions electronically. The Rule requires appropriate safeguards to protect
the privacy of personal health information, and sets limits and conditions on the uses and
disclosures that may be made of such information without patient authorization. The Rule also
gives the patient rights over their health information, including rights to examine and obtain a copy
of their health records, and to request corrections. The Privacy Rule is located at 45 CFR Part 160
and Subparts A and E of Part 164.
http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html
38
The Security Rule
The HIPAA Security Rule establishes national standards to protect individuals’ electronic personal
health information that is created, received, used, or maintained by a covered entity. The Security
Rule requires appropriate administrative, physical and technical safeguards to ensure the
confidentiality, integrity, and security of electronic protected health information. The Security Rule
is located at 45 CFR Part 160 and Subparts A and C of Part 164.
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/index.html
Other HIPAA Administrative Simplification Rules are administered and enforced by the Centers
for Medicare & Medicaid Services, and include:
Transactions and Code Sets Standards
On January 16, 2009, HHS published two final transactions and code set rules to adopt updated
HIPAA standards; these rules are available at the Federal Register.
Transactions are electronic exchanges involving the transfer of information between two parties for
specific purposes. For example, a health care provider will send a claim to a health plan to request
payment for medical services. The Health Insurance Portability & Accountability Act of 1996
(HIPAA) named certain types of organizations as covered entities, including health plans, health
care clearinghouses, and certain health care providers. HIPAA also adopted certain standard
transactions for Electronic Data Interchange (EDI) of health care data. These transactions
are: claims and encounter information, payment and remittance advice, claims status, eligibility,
enrollment and disenrollment, referrals and authorizations, and premium payment. Under HIPAA,
if a covered entity conducts one of the adopted transactions electronically, they must use the
adopted standard. This means that they must adhere to the content and format requirements of each
standard. HIPAA also adopted specific code sets for diagnosis and procedures to be used in all
transactions. The HCPCS (Ancillary Services/Procedures), CPT-4 (Physicians Procedures), CDT
(Dental Terminology), ICD-9 (Diagnosis and hospital inpatient Procedures), ICD-10 (As of
October 1, 2013) and NDC (National Drug Codes) codes with which providers and health plan are
familiar, are the adopted code sets for procedures, diagnoses, and drugs.
To view these rules and information sheets for both sets of standards see the following link on the
CMS website: https://www.cms.gov/Regulations-and-Guidance/Administrative-
Simplification/Transactions/TransactionsOverview.html
Finally, HIPAA adopted standards for unique identifiers for Employers and Providers, which must
also be used in all transactions, as required by the standard.
Employer Identifier Standard
The Health Insurance Portability & Accountability Act of 1996 (HIPAA) requires that employers
have standard national numbers that identify them on standard transactions. The Employer
Identification Number (EIN), issued by the Internal Revenue Service (IRS), was selected as the
identifier for employers and was adopted effective July 30, 2002. For more information, see the
39
following CMS webpage: https://www.cms.gov/Regulations-and-Guidance/Administrative-
Simplification/Unique-Identifier/UniqueIdentifiersOverview.html
National Provider Identifier Standard
The National Provider Identifier (NPI) is a Health Insurance Portability and Accountability Act
(HIPAA) Administrative Simplification Standard. The NPI is a unique identification number for
covered health care providers. Covered health care providers and all health plans and health care
clearinghouses must use the NPIs in the administrative and financial transactions adopted under
HIPAA. The NPI is a 10-position, intelligence-free numeric identifier (10-digit number). This
means that the numbers do not carry other information about healthcare providers, such as the state
in which they live or their medical specialty. The NPI must be used in lieu of legacy provider
identifiers in the HIPAA standards transactions. As outlined in the Federal Regulation, The Health
Insurance Portability and Accountability Act of 1996 (HIPAA), covered providers must also share
their NPI with other providers, health plans, clearinghouses, and any entity that may need it for
billing purposes. For more information, see the following CMS webpage:
https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/Unique-
Identifier/NPIs.html
Additional HIPAA Internet Resources
http://www.hhs.gov/ocr/hipaa/
This site covers a variety of issues and includes the information on HIPAA Privacy for individuals
and professionals.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-
MLN/MLNProducts/Downloads/HIPAAPrivacyandSecurity.pdf
This resource developed by the CMS provides basic compliance information for health care
providers.
https://www.hhs.gov/hipaa/for-professionals/index.html
The site includes the HIPAA statute, related materials, compliance information, and downloads
prepared by The Department of Health and Human Services (HHS).
U.S. Laws and Legislation on Human Trafficking
Federal Anti-Trafficking Laws: http://www.state.gov/j/tip/laws/
The Trafficking Victims Protection Act (TVPA) of 2000 is the first comprehensive federal law to
address trafficking in persons. The law provides a three-pronged approach: prevention, protection,
and prosecution. The TVPA was reauthorized through the Trafficking Victims Protection
Reauthorization Acts (TVPRA) of 2003, 2005, 2008, and 2013. Under U.S. federal law, “severe
forms of trafficking in persons” include sex trafficking and labor trafficking:
• Sex trafficking is the recruitment, harboring, transportation, provision, or obtaining of a
person for the purposes of a commercial sex act, in which commercial sex acts are induced
40
by force, fraud, or coercion, or in which the person induced to perform such an act has not
attained 18 years of age, (22 USC § 7102; 8 CFR § 214.11(a)).
• Labor trafficking is the recruitment, harboring, transportation, provision, or obtaining of a
person for labor or services, through the use of force, fraud, or coercion for the purposes of
subjection to involuntary servitude, peonage, debt bondage, or slavery, (22 USC § 7102).
• Sex Trafficking of Children or by Force, Fraud, or Coercion Act criminalizes sex
trafficking, which is defined as causing a person to engage in a commercial sex act under
statutorily defined conditions of force fraud, coercion or conduct involving persons under
the age of 18. (18 USC § 1591) http://www.justice.gov/crt/about/crm/1581fin.php
The Trafficking Victims Protection Act of 2000 (TVPA) of 2000 is the cornerstone of Federal
human trafficking legislation; it established several methods of prosecuting traffickers, preventing
human trafficking, and protecting victims and survivors of trafficking. The act establishes human
trafficking and related offenses as federal crimes, and attaches severe penalties to them. It also
mandates restitution be paid to victims of human trafficking. It established the Office to Monitor
and Combat Trafficking in Persons, which publishes a Trafficking in Persons (TIP) report each
year. The TIP report describes efforts of countries to combat human trafficking. The act also
established the Interagency Task Force to Monitor and Combat Trafficking for implementation of
the TVPA. The TVPA protects victims and survivors by establishing the T visa, which allows
victims and their families to become temporary U.S. residents, eligible to become permanent
residents after three years.
The Trafficking Victims Protection Reauthorization Act of 2003 (TVPRA of 2003) established
a federal civil right of action for trafficking victims to sue their traffickers and added human
trafficking to the list of crimes that can be charged under the Racketeering Influenced Corrupt
Organizations (RICO) statute. It also included provisions to protect victims and their families from
deportation, and a requirement that the Attorney General report to Congress annually on activities
of the U.S. government in the fight against trafficking.
The Trafficking Victims Protection Reauthorization Act of 2005 (TVPRA of 2005) included a
pilot program to sheltering minor survivors of human trafficking, and grant programs to assist state
and local law enforcement combat trafficking. It also expanded measures to combat trafficking
internationally, including provisions to fight sex tourism and regulation of government contracts to
ensure against contracting with individuals or organizations that engage in human trafficking.
The Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA of 2008) included
new prevention strategies and government requirements that provide information about workers’
rights to all people applying for work and education visas. It put in place new systems to gather and
report human trafficking data. In addition to the prevention strategies, it expanded the protections
available with the T visa, and required that all unaccompanied alien children be screened as
potential victims of human trafficking. It also enhanced criminal sanctions against traffickers, and
expanded definitions of various types of trafficking to facilitate prosecution.
The Trafficking Victims Protection Reauthorization Act of 2013 (TVPRA 2013) passed as an
amendment to the Violence Against Women Act. It establishes programs to ensure that U.S.
citizens do not purchase products made by victims of trafficking, and to prevent child marriage. It
puts in place emergency response provisions within the State Department to respond quickly to
41
disaster areas and crises where people are particularly susceptible to trafficking. It strengthens
collaboration with state and local law enforcement to ease charging and prosecuting traffickers.
1
Resources:
1
The Polaris Project: http://www.polarisproject.org/
National Human Trafficking Resource Center: 1-888-373-7888
Fact Sheet on Human Trafficking:
http://www.acf.hhs.gov/sites/default/files/orr/fact_sheet_human_trafficking_english.pdf
Patient Protection and Affordable Care Act of 2010
(ACA)
On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act
(ACA). The law puts in place comprehensive health insurance reforms, including patient rights
and protections, expanded coverage, and cost savings. The law makes preventive care, including
family planning and preventive care, more accessible and affordable for many Americans. The
information and resources provided here are intended to assist Title X-funded family planning
centers and other safety net providers implement the law.
About the Law
http://www.hhs.gov/healthcare/about-the-law/index.html
Key Features of the Affordable Care Act
http://www.hhs.gov/healthcare/facts/timeline/index.html
Affordable Care Act and Preventive Health Services for Women
https://www.hhs.gov/opa/title-x-family-planning/preventive-services/womens-services/index.html
Enroll America Materials
http://familiesusa.org/enroll-america-materials
B. Michigan Family Planning Information
Legislation, Resources, Program Requirements
Michigan Public Health Laws
Michigan Department of Health and Human Services (MDHHS) has the primary responsibility in
Michigan to receive and administer state and federal funds for family planning services. Family
planning services are authorized under the State of Michigan's Public Health Code, Section
333.9131. Guidelines for MDHHS administration of the federal program are based on requirements
as cited in the document "Program Guidelines for Project Grants for Family Planning Services."
42
Additional guidelines may be required through either the federal or state directives. The program
guidelines found in this document interpret the law and regulations in the form of standards and
provides an orientation to the federal and state perspective on family planning. This manual is
written to define minimum standards (requirements) and give recommendations (guidelines) for
quality care, utilizing nationally accepted standards of practice.
The philosophy of the MDHHS Family Planning Program, consistent with that of Title X. Family
Planning, is a preventive health measure which positively impacts on the health and well-being of
women, children and families. Effective family planning programs are essential health care
delivery interventions that correlate with decreased high risk pregnancy and decreased maternal and
infant mortality and morbidity. Services provided through family planning clinics allow women
and men to make well-informed reproductive health choices. MDHHS funded family planning
clinics are specifically created to address the unmet family planning needs of women and men
below poverty, and those slightly above poverty, but still considered low income, and to provide
access to those with special needs (such as teens). No one is denied services because of inability to
pay.
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.9131 Family planning services; publicity; request by medically indigent individual;
clinical abortions.
Sec. 9131.
(1) The department, and under its supervision a local health department, shall publicize the
places where family planning services are available. The publicity shall state that receipt of
public health services is not dependent on a request or nonrequest for family planning services.
(2) An effort shall not be made to coerce a medically indigent individual to request or not
request family planning services. The department, and under its supervision a local health
department, shall provide family planning services to a medically indigent individual upon the
individual's request in accordance with standards established under section 9133. Clinical
abortions shall not be considered a method of family planning.
History: 1978, Act 368, Eff. Sept. 30, 1978
Popular Name: Act 368
Appropriations
http://www.legislature.mi.gov/(S(iliqdxmzjt4wjq45gjwls0j2))/mileg.aspx?page=AppropriationBills
Passed
43
Public Health Codes
The full text of Michigan’s Public Health Code can be found at the first link. The following links
offer information on specific information crucial to Title X program implementation.
Full Text:
http://www.legislature.mi.gov/printDocument.aspx?objName=mcl-act-368-of-1978&version=txt
HIV Testing Law:
http://www.michigan.gov/documents/mdch/FAQ_HIV_Test_Consent_2-25-2011_346590_7.pdf
Pharmacy:
http://www.legislature.mi.gov/(S(5x5gcu3ujstowyqx4jnscorx))/mileg.aspx?page=getObject&object
Name=mcl-333-17745
http://www.legislature.mi.gov/(S(c2zhwkmjwxrmdx55biawhr2t))/mileg.aspx?page=getObject&obj
ectName=mcl-333-17745a
Mental Health Services:
http://www.legislature.mi.gov/(S(a1u31onkc2j2o5iupuptztyk))/mileg.aspx?page=GetMCLDocument&objec
tname=Mcl-Act-258-of-1974&queryid=12811010&highlight=mental%20health%20services
Substance Abuse:
http://www.legislature.mi.gov/(S(3me3trinm1wmjw255cik40155))/milet.aspx?page=getobject&obj
ectname=mcl-368-1978-6&query=on&highlight=substance AND abuse
PA 360 of 2002:
http://legislature.mi.gov/doc.aspx?mcl-333-1091
Confidentiality of Minors:
http://www.michigan.gov/documents/mdch/Michigan_Minor_Consent_Laws_for_Sexual_Health_2
92774_7.pdf
When Teens Disclose Dating Violence to Health Care Providers: A Guide to Confidentiality and
Reporting Laws in Michigan, November 2010, National Center for Youth Law in collaboration
with The Family Violence Prevention Fund.
http://www.michigan.gov/documents/mdch/MI_TDVConfidentialityReporting_11-15-10-
final_380362_7.pdf
Adoption:
http://www.legislature.mi.gov/(S(4r5mae55b14d5unrn5czok55))/mileg.aspx?page=LoadVirtualDoc
&BookmarkID=6495
Licensing for Health Care Professionals:
http://www.michigan.gov/lara/0,4601,7-154-35299_63294---,00.html
44
Drug Control License & Dispensing of Pharmaceuticals
3
33.17745 Drug control license; patient's chart or clinical record to include record of drugs
dispensed; delegating authority to dispense drugs; storage of drugs; container; label; complimentary
starter dose drug; information; compliance with MCL 333.7303a; inspection of locations; limitation
on delegation; receipt of complimentary starter dose drugs by pharmacist; "complimentary starter
dose" defined.
Sec. 17745. (1) Except as otherwise provided in this subsection, a prescriber who wishes to dispense
prescription drugs shall obtain from the board a drug control license for each location in which the storage
and dispensing of prescription drugs occur. A drug control license is not necessary if the dispensing occurs
in the emergency department, emergency room, or trauma center of a hospital licensed under article 17 or if
the dispensing involves only the issuance of complimentary starter dose drugs.
(2) Except as otherwise authorized for expedited partner therapy in section 5110 or as provided in section
17744a or 17744b, a dispensing prescriber shall dispense prescription drugs only to his or her own patients.
(3)
A
dispensing prescriber shall include in a patient's chart or clinical record a complete record, including
prescription drug names, dosages, and quantities, of all prescription drugs dispensed directly by the
dispensing prescriber or indirectly under his or her delegatory authority. If prescription drugs are dispensed
under the prescriber's delegatory authority, the delegatee who dispenses the prescription drugs shall initial
the patient's chart, clinical record, or log of prescription drugs dispensed. In a patient's chart or clinical
record, a dispensing prescriber shall distinguish between prescription drugs dispensed to the patient,
pr
escription drugs prescribed for the patient, prescription drugs dispensed or prescribed for expedited partner
therapy as authorized in section 5110, and prescription drugs dispensed or prescribed as authorized under
section 17744a or 17744b. A dispensing prescriber shall retain information required under this subsecti
on
f
or not less than 5 years after the information is entered in the patient's chart or clinical record.
(4)
A
dispensing prescriber shall store prescription drugs under conditions that will maintain their stability
,
i
ntegrity, and effectiveness and will assure that the prescription drugs are free of contamination,
deterioration, and adulteration.
(5)
A
dispensing prescriber shall store prescription drugs in a substantially constructed, securely lockabl
e
cab
inet. Access to the cabinet shall be limited to individuals authorized to dispense prescription drugs in
compliance with this part and article 7.
(6) Unless otherwise requested by a patient, a dispensing prescriber shall dispense a prescription drug in a
s
afety closure container that complies with the poison prevention packaging act of 1970, 15 USC 1471 to
1477.
(7) A dispensing prescriber shall dispense a drug in a container that bears a label containing all of the
f
ollowing information:
(a) The name and address of the location from which the prescription drug is dispensed.
(b)
E
xcept as otherwise authorized under section 5110, 17744a, or 17744b, the patient's name and recor
d
number.
(c) The date the prescription drug was dispensed.
(d) The prescriber's name or, if dispensed under the prescriber's delegatory authority, the name of th
e
delegatee.
(e)
T
he directions for use.
(f) The name and strength of the prescription drug.
(g
) T
he quantity dispensed.
(h) The expiration date of the prescription drug or the statement required under section 17756.
(8)
A
dispensing prescriber who dispenses a complimentary starter dose drug to a patient shall give the
patient the information required in this subsection, by dispensing the complimentary starter dose drug to the
patient in a container that bears a label containing the required information or by giving the patient a writte
n
doc
ument that may include, but is not limited to, a preprinted insert that comes with the complimentary
45
starter dose drug and that contains the required information. The information required to be given to the
patient under this subsection includes all of the following:
(a) The name and strength of the complimentary starter dose drug.
(b) Directions for the patient's use of the complimentary starter dose drug.
(c) The expiration date of the complimentary starter dose drug or the statement required under section
17756.
(9) The information required under subsection (8) is in addition to, and does not supersede or modify, other
state or federal law regulating the labeling of prescription drugs.
(10) In addition to meeting the requirements of this part, a dispensing prescriber who dispenses controlled
substances shall comply with section 7303a.
(11) The board may periodically inspect locations from which prescription drugs are dispensed.
(12) The act, task, or function of dispensing prescription drugs shall be delegated only as provided in this
part and sections 16215, 17048, 17076, 17212, and 17548.
(13) A supervising physician may delegate in writing to a pharmacist practicing in a hospital pharmacy
within a hospital licensed under article 17 the receipt of complimentary starter dose drugs other than
controlled substances as defined by article 7 or federal law. When the delegated receipt of complimentary
starter dose drugs occurs, both the pharmacist's name and the supervising physician's name shall be used,
recorded, or otherwise indicated in connection with each receipt. A pharmacist described in this subsection
may dispense a prescription for complimentary starter dose drugs written or transmitted by facsimile,
electronic transmission, or other means of communication by a prescriber.
(14) As used in this section, "complimentary starter dose" means a prescription drug packaged, dispensed,
and distributed in accordance with state and federal law that is provided to a dispensing prescriber free of
charge by a manufacturer or distributor and dispensed free of charge by the dispensing prescriber to his or
her patients. 1978, Act 368, -- Am. 2014, Act 525, Imd. Eff. Jan. 14, 2015
Sexual Coercion Legislation
Sexual coercion can occur by several different means. A perpetrator may be in a position of
authority over a minor, use a weapon, violence or threat of violence, or may be a member of the
minor’s household. Michigan statutes describing criminal sexual conduct are found at these links:
In Michigan, the law regarding sexual assault is called the Criminal Sexual Conduct Act. It is
gender neutral and includes marital, stranger, date, acquaintance, and child sexual assault. For a
description and summary see: http://www.michigan.gov/datingviolence/0,4559,7-233-46552-
169748--,00.html
Felony Criminal Sexual Conduct (mcl-720-520c)
http://www.legislature.mi.gov/(qlov2kqges0ash55unx2mxnp)/mileg.aspx?page=GetMCLDocumen
t&objectname=mcl-750-520c
Felony Criminal Sexual Conduct (mcl-720-520d)
http://www.legislature.mi.gov/(S(zll5p122a0j0u3nn4kx1zfru))/mileg.aspx?page=GetObject&object
name=mcl-750-520d
Misdemeanor Criminal Sexual Conduct (mcl-750-520e)
http://www.legislature.mi.gov/(ast5ns55wvnujh55b54mba55)/mileg.aspx?page=GetMCLDocumen
t&objectname=mcl-750-520e
46
Professional Training and Resources
http://www.michigan.gov/mdhhs/0,5885,7-339-71548_7261_18139---,00.html
Child Protection & Mandated Reporting Legislation
In Michigan the following professionals are considered mandatory reporters of child abuse and
neglect:
• Physicians; coroners; dentists; registered dental hygienists; medical examiners; nurses;
persons licensed to provide emergency medical care; audiologists;
• School administrators; school counselors; school teachers; regulated child care providers;
• Psychologists; marriage and family therapists; licensed professional counselors; certified
social workers; social workers; social work technicians;
• Law enforcement officers.
• Members of the clergy
The following links provide further assistance:
DHS Mandated Reporters Page
http://www.michigan.gov/dhs/0,1607,7-124-5452_7119_44443---,00.html
Michigan Mandated Reporters Resource Guide
http://www.michigan.gov/documents/dhs/Pub-112_179456_7.pdf
Michigan Child Protection Law (Act 238 Of 1975)
http://www.michigan.gov/documents/DHS-PUB-0003_167609_7.pdf
Michigan Human Trafficking Law
The Michigan law banning human trafficking went into effect on August 24, 2006. The law was
strengthened in 2010 and the changes took effect on April 1, 2011. These changes included
enhanced restitution for human trafficking victims. Victims can ask for all costs suffered as a
consequence of their bondage, such as medical costs, and can also ask for a restitution order that
recognizes the value of the years of their life lost due to the crime.
The human trafficking law was overhauled in 2014. The 2014 legislation includes safe harbor
provisions, stronger tools to hold traffickers accountable, and created a standing Human Trafficking
Commission within the Department of Attorney General and a Human Trafficking Health Advisory
Board within the Department of Health and Human Services. Most of the new legislation took
effect on January 14, 2015. (For a summary of the 2014 Human Trafficking Laws, see below.)
http://www.michigan.gov/ag/0,4534,7-164-60857_60859---,00.html
47
Michigan law prohibits:
1. Forced labor or services (MCL 750.462b) by force, fraud, or coercion
o Force includes, but is not limited to, physical violence, threat of physical violence or
actual physical restraint or confinement or threat of actual physical restraint of
confinement, without regard to whether injury occurs.
o Fraud includes, but not limited to, a false or deceptive offer of employment or
marriage.
o Coercion includes but is not limited to:
a. Threatening to harm or physically restrain any individual or the creation of
any scheme, plan, or pattern intended to cause an individual to believe that
failure to perform an act would result in psychological, reputational, or
financial harm to, or physical restraint of any individual.
b. Abusing or threatening abuse of the legal system, including threats of arrest
or deportation without regard to whether the individual being threatened is
subject to arrest or deportation.
c. Knowingly destroying, concealing, removing, confiscating, or possessing
any passport or other immigration document or any other government
identification document from any individual, regardless of whether the
documents are fraudulent or fraudulently obtained.
2. Debt Bondage (MCL 750.462c)
3. Enterprise Liability; Financially Benefitting (MCL 750.462d)
4. Trafficking a Minor (MCL 750.462e)
o Covers both sex trafficking and labor trafficking of a minor
o No Force, Fraud or Coercion required in the case of minors
o Regardless of whether the person knows the age of the minor
Increased Protections for Victims in the 2014 Michigan Human Trafficking Legislation:
Safe Harbor - Safe harbor was one of the key reforms in the 2014 Michigan human trafficking
legislation.
1. 2014 PA 336 provides Safe Harbor to minor sex trafficking victims by presuming that a
minor found engaging in prostitution is a victim of human trafficking and mandates law
enforcement to refer the minor victims for appropriate treatment within the Department of
Health and Human Services.
2. 2014 PA 342 provides Safe Harbor to minor sex trafficking victims by establishing probate
court jurisdiction for minor human trafficking victims who are dependent and in danger of
substantial harm.
3. 2014 PA 335 provides Safe Harbor by allowing victims of human trafficking to clear their
criminal record of crimes they were forced to commit by their traffickers.
4. 2014 PA 334 provides adult human trafficking victims safe harbor through a diversion
process to avoid prostitution convictions.
Stronger Tools to Hold Traffickers Accountable in the 2014 Human Trafficking Legislation:
48
1. Increases the crime of buying sex from a minor to a felony.
2. Overhauls the human trafficking portion of the penal code in line with the 2014
human trafficking provisions.
3. Removes the statute of limitations in cases where trafficking is punishable by life
and otherwise lengthened the statute of limitations for bringing charges against
traffickers.
4. Strengthens penalties against sex-buyers (johns) by revising the definition of Sex
Offender to include the new crime of soliciting prostitution from a minor and
includes those engaging in trafficking minors for sex; and requires johns to be
placed on sex offender registry.
5. Removes outdated gender-specific references regarding prostitution, and increases
fines for operating a place of prostitution.
6. Updates the Crime Victim's Rights Act to account for the 2014 human trafficking
laws.
7. Makes human trafficking of a child an offense that must be reported by mandatory
reporters to Child Protective Services.
8. Reflects changes in the sentencing guidelines for increased penalties against
criminals soliciting sex from minors under 16 years of age.
9. Amends civil nuisance provisions to allow human trafficking violations to qualify
as a nuisance.
Michigan Human Trafficking Resources:
https://humantraffickinghotline.org/state/michigan
National Human Trafficking Resource Center: 1-888-373-7888
Fact Sheet on Human Trafficking:
http://www.acf.hhs.gov/sites/default/files/orr/fact_sheet_human_trafficking_english.pdf
Expedited Partner Therapy Legislation
Public Act 525 of 2014 (MCL 333.5110) authorized the use of expedited partner therapy (EPT) in
Michigan for certain sexually transmitted diseases as designated by the state of health department.
In January 2015, the department designated chlamydia and gonorrhea as diseases for which the use
of EPT is appropriate. Following is a copy of the legislation:
http://www.legislature.mi.gov/(S(nj1cpiegpl0cokontzv2ooxv))/documents/mcl/pdf/mcl-333-
5110.pdf
49
MDHHS developed the following document to provide guidance for health care providers using
EPT: http://michigan.gov/documents/mdch/EPT_for_Chlamydia_and_Gonorrhea_-
_Guidance_for_Health_Care_Providers_494241_7.pdf
MDHHS developed the following information sheet for patient and partners being offered
expedited partner therapy (EPT):
http://michigan.gov/documents/mdch/EPT_Information_Sheet_for_Patients_and_Partners_494242
_7.pdf
Additional Michigan Resources
Zika virus resources:
CDC Zika Website: http://www.cdc.gov/zika/
MDHHS Webpage for Michigan Residents and Healthcare providers:
http://www.michigan.gov/emergingdiseases/0,4579,7-186-77096---,00.html
Immunizations:
http://www.michigan.gov/documents/They-re-Not-Just-For-Kids_7195_7.pdf
HIV Testing Counseling and Referral Services:
http://www.michigan.gov/mdhhs/0,5885,7-339-71550_2955_2982---,00.html
Genetics:
https://migrc.org/
Michigan Medicaid Policy Information:
Links to the Medicaid Provider Manual and Medicaid Policy Bulletins
http://www.michigan.gov/mdhhs/0,5885,7-339-71551_2945_42542_42543_42546_42553-188444--,00.html
The Medicaid Provider Manual contains chapters on: Family Planning Clinics, Healthy Michigan
Plan, Medicaid Health Plans, and Pharmacy which are particularly relevant to Title X clinics.
http://www.mdch.state.mi.us/dch-medicaid/manuals/MedicaidProviderManual.pdf
Medicaid Billing and Reimbursement Information:
Procedure codes and fee screens are found on MDHHS Provider Specific Information.
http://www.michigan.gov/mdhhs/0,5885,7-339-71551_2945_42542_42543_42546_42551-159815--,00.html
CHAMPS enrollment and specific billing questions or concerns should be directed to the Medicaid
Provider Helpline, either by phone 1-800-292-2550 or e-mail [email protected].
50
MDHHS Family Planning Minimum Program
Requirements (MPRs)
ELEMENT DEFINITION:
Family Planning services offer comprehensive preventive reproductive health care that
includes: general health assessment and examination; routine screening for sexually
transmitted diseases, HIV infections, cervical and breast cancer, high blood pressure, anemia,
infertility problems and selected infections; contraception, pregnancy testing and counseling
services; client and community educations; and follow-up and referrals for medical or
socio/economic problems. The primary mission is to provide individuals the information and
means to exercise personal choice in determining the number and spacing of their children.
MINIMUM PROGRAM REQUIREMENTS:
1. Provide 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). Reference: 42 CFR CH. 1 (10-1-00 Edition) §59.5
(a)(1).
2. Provide services without subjecting individuals to any coercion to accept services or to
employ or not to employ any particular methods of family planning. Acceptance of services
must be solely on a voluntary basis and may not be made a prerequisite to eligibility for, or
receipt of, any other services, assistance from or participate in any other program.
Reference: 42 CFR CH. 1 (10-1-00 Edition) §59.5 (a)(2).
3. Provide services in a manner which protects the dignity of the individual. Reference: 42
CFR CH. 1 (10-1-00 Edition) §59.5 (a)(3).
4. Provide services without regard to religion, race, color, national origin, handicapping
condition, age, sex, number of pregnancies, or marital status. Reference: 42 CFR CH. 1
(10-1-00 Edition) §59.5 (a)(4).
5. Not provide abortion as a method of family planning. Offer pregnant women the
opportunity to be provided information and counseling regarding each of the following
options: (A) Prenatal care and delivery; (B) Infant care, foster care, or adoption; and (C)
Pregnancy termination. Reference: 42 CFR CH. 1 (10-1-00 Edition) §59.5 (a)(5) and (i).
6. Provide that priority in the provision of services will be given to persons from low-income
families. Reference: 42 CFR CH. 1 (10-1-00 Edition) §59.5 (a)(6).
7. Provide that no charge will be made for services provided to any persons from a low-
income family (at or below 100% of the Federal Poverty Level) except to the extent that
payment will be made by a third party (including a government agency) which is authorized
51
to or is under legal obligation to pay this charge. Reference: 42 CFR CH. 1 (10-1-00
Edition) §59.5 (a)(7).
8. Provide that charges will be made for services to persons other than those from low-income
families in accordance with a schedule of discounts based on ability to pay, except that
charges to person from families whose annual income exceeds 250 percent of the levels set
forth in the most recent Poverty Guidelines will be made in accordance with a schedule of
fees designed to recover the reasonable cost of providing services. Reference: 42 CFR
CH. 1 (10-1-00 Edition) §59.5 (a)(8).
9. If a third party (including a government agency) is authorized or legally obligated to pay for
services, all reasonable efforts must be made to obtain the third-party payment without
application of any discounts. Where the cost of services is to be reimbursed under title
XIX, XX, or XXI of the Social Security Act, a written agreement with the title agency is
required. Reference: 42 CFR CH. 1 (10-1-00 Edition) §59.5 (a)(9).
10. Provide for an advisory committee. Reference: 42 CFR CH. 1 (10-1-00 Edition) §59.5
(a)(11).
11. Provide for medical services related to family planning (including physician's consultation,
examination prescription, and continuing supervision, laboratory examination, contraceptive
supplies) and necessary referral to other medical facilities when medically indicated, and
provide for the effective usage of contraceptive devices and practices. Reference: 42 CFR
CH. 1 (10-1-00 Edition) §59.5 (b)(1).
12. Provide for social services related to family planning, including counseling, referral to and
from other social and medical services agencies, and any ancillary services which may be
necessary to facilitate clinic attendance. Reference: 42 CFR CH. 1 (10-1-00 Edition)
§59.5 (b)(2).
13. Provide for informational and educational programs designed to: achieve community
understanding of the objectives of the program; inform the community of the availability of
services; and promote continued participation in the project by persons to whom family
planning services may be beneficial. Reference: 42 CFR CH. 1 (10-1-00 Edition) §59.5
(b)(3).
14. Provide for orientation and in-service training for all project personnel. Reference: 42
CFR CH.1 (10-1-00 Edition) §59.5 (b)(4).
15. Provide services without the imposition of any durational residency requirement or
requirement that the patient be referred by a physician. Reference: 42 CFR CH. 1 (10-1-
00 Edition) §59.5 (b)(5).
16. Provide that the family planning medical services will be performed under the direction of a
physician with special training or experience in family planning. Reference: 42 CFR CH.
1(10-1-00 Edition) §59.5 (b)(6).
52
17. Provide that all services purchased for project participants will be authorized by the project
director or his/her designee on the project staff. Reference: 42 CFR CH. 1 (10-1-00
Edition) §59.5 (b)(7).
18. Provide for coordination and use of referral arrangements with other providers of health
care services, local health and welfare departments, hospitals, voluntary agencies, and
health services projects support by other federal programs. Reference: 42 CFR CH. 1 (10-
1-00 Edition)§59.5 (b)(8).
19. Provide that if family planning services are provided by contract or other similar
arrangements with actual providers of services, services will be provided in accordance with
a plan which establishes rates and method of payment for medical care. These payments
must be made under agreements with a schedule of rates and payments procedures
maintained by the agency. The agency must be prepared to substantiate that these rates are
reasonable and necessary. Reference: 42 CFR CH. 1 (10-1-00 Edition) §59.5 (b)(9).
20. Provide, to the maximum feasible extent, an opportunity for participation in the
development, implementation, and evaluation of the project by persons broadly
representative of all significant elements of the population to be served, and by others in the
community knowledgeable about the community's needs for family planning services.
Reference: 42 CFR CH. 1(10-1-00 Edition) §59.5 (b)(10).
21. Any funds granted shall be expended solely for the purpose of delivering Title X Family
Planning Services in accordance with an approved plan & budget, regulations, terms &
conditions and applicable cost principles prescribed in 45 CFR Part 74 or Part 92, as
applicable. Reference: 42 CFR CH. 1 (10-1-00 Edition) §59.9.
These Minimum Program Requirements (MPR’s) are used as indicators for the MDHHS
accreditation/ site review process to determine program compliance. They are based on the Title X
Statute [42 CFR CH. 1 (10-1-00 Edition) §59] and are consistent with, the Office of Population
Affairs (OPA) Program Requirements, and the MDHHS Title X Family Planning Program
Standards and Guidelines. Each indicator refers to a minimum standard that must be in place to be
in compliance for MDHHS Family Planning Program grant status as a family planning sub-
recipient.
The Accreditation/Site Review Tool identifies the minimum program requirements, references, and
the measurements used to determine compliance with each MPR indicator. Indicators determined
to be out of compliance must to be corrected. The Family Planning Indicator tool can be found on
the Michigan Local Public Health Accreditation website: https://accreditation.localhealth.net/ and
on the MDHHS Family Planning website at: http://www.michigan.gov/familyplanning
Compliance with the Minimum Program Requirements (MPRs) is attested to in the contract process
between sub-recipients and MDHHS. The Comprehensive Agreement between MDHHS and local
health departments and the Standard Agreement between private non-profit sub-recipients and
MDHHS include these assurances.
53
Michigan Department of Health and Human Services
Minimum Reporting Requirements (MRRs)
The federally mandated minimum program reporting requirements for sub-recipients are explained
here. Required reporting documents must be submitted to MDHHS by the stated deadlines. These
requirements are subject to change as legislative, fiduciary and other aspects of the program
change.
These documents include the:
The Family Planning Annual Report (FPAR)
Family Planning Health Care Plan
These reports must be submitted accurately and timely. The information is used for essential
activities not limited to legislative reporting, federal reporting requirements for the State,
budgeting, funding allocations, and other aspects of financial management. In addition, this data
provides statistical information needed for program evaluation, assessment of need, and other
activities required of Title X Family Planning Projects.
Title X Family Planning Sub-recipients must also comply with Michigan’s mandatory reporting
law under the Child Protection Law and must have policies and procedures in place that comply
with mandatory reporting under Michigan’s Child Protection Law.
The following list summarizes the required Title X reports, their forms and due dates. This list is
provided to sub-recipients as part of the contracting process and required forms are provided to
sub-recipients prior to their due dates.
54
Michigan Department of Health and Human Services
Minimum Reporting Requirements Family Planning
Program
Required Report
Source Document
Reason/Use
Due Date
FPAR
Profile Sheet
Table 1
Table 2
Table 3
Table 4
Table 5
Table 6
Table 7
Table 8
Table 9
Table 10
Table 11
Table 12
Table 13
Table 14
Table 15
Table 16
Client visit record
Client visit record
Client visit record
Client visit record
Client visit record
Client visit record
Client visit record
Client visit record
Client visit record
Client visit record
Client visit record
Client visit record
Client visit record
General ledger or
Accounting reports
Accounting reports
Client visit record
Federal
Requirement
Michigan
Requirement
MID –Year Report
(Jan-June) due July
15
Annual Report (Jan-
Dec) due January 10
Family Planning Needs
Assessment and Health
Care Plan
Program Statistics
Federal
Requirement
Due September 15
Project Outputs:
Target
Measure
Total
Performance
Expectation
State Funded Minimum Performance
Expected
Unduplicated number of
Clinic Users
Percent
95%
Number
55
Michigan Title X Family Planning
Annual Health Care Plan Guidance
The Annual Health Care Plan highlights a family planning agency’s progress during the current
fiscal year, along with identifying plans for next fiscal year, including priority population(s) and
targeted service area(s), describing the agency’s capacity to provide Title X services, and
outlining service delivery plans. This document provides family planning agencies guidance on
the submission requirements for the Annual Health Care Plan narrative and accompanying
documents.
I. Program Description
A. Highlight significant program achievements, milestones, or other notable
accomplishments during this past fiscal year.
B. Highlight program and community changes (e.g., staffing or administrative
changes, supply issues, local policy/community issues, or provider relationships)
that occurred this past fiscal year, focusing on service delivery and priority
population(s) affects, and potential solutions.
II. Priority Population(s) and Target Service Area(s)
A. Provide a brief description of the agency’s priority population(s) and target
service area(s).
B. Insert the table below into this section’s narrative and indicate the projected
number of unduplicated users during calendar year 2018 for each table row. For
demographic categories, refer to FPAR Table 1. For income level, refer to FPAR
Table 4.
Demographic Category
Unduplicated
Users 2018
Males
Females
Teens
Income Level
Unduplicated
Users 2018
At or below 100% of poverty
Above 100% but no more than 150%
Above 150% but not more than 200%
Above 200% but not more than 250% of poverty
Above 250% of poverty
III. Agency Capacity & Staffing Structure
A. Provide a copy of the agency’s current family planning organizational chart as an
attachment.
B. Identify and report all services to be provided to clients under Title X by
completing the Family Planning Services Provided document (See Family
Planning website, ‘Information for Providers’).
56
C. Include the agency’s current Sliding Fee Scale and Fee Schedule. Submit as an
attachment.
D. Verify and submit the agency’s coordinator information, main office hours,
agency clinic location(s), and clinic hours of operation on the Family Planning
Agency Clinic Locations & Schedules (Attachment A).
IV. Program Work Plan
A. Provide a brief progress report on the previous year’s goals, objectives, and
activities using the Family Planning Work Plan Progress Report (See Family
Planning website, ‘Information for Providers’), including community education
and promotion activities.
B. Develop project goals and objectives for next fiscal year that are specific,
measurable, attainable, realistic, and time specific (S.M.A.R.T.), and address Title
X priorities. Submit on the required work plan format, Family Planning Work
Plan (See Family Planning website, ‘Information for Providers’) as an
attachment. Include at least one project goal and objective for Community
Education Activities (See Section 11.2 of the Michigan Title X Family Planning
Standards and Guidelines Manual) and at least one project goal and objective for
Community Promotion Activities (See Section 11.3 of the Michigan Title X
Family Planning Standards and Guidelines Manual). Goals and objectives should
reflect regional needs and engage priority populations.
V. Family Planning Advisory Council (See Section 11.1 of the Michigan Title X Family
Planning Standards and Guidelines Manual).
A. Provide a brief description of the Advisory Council’s purpose.
B. Include the following Advisory Council documents as attachments: next fiscal
year’s meeting schedule, member roster, and minutes from the last held Council
meeting.
VI. Information and Education (I&E) Committee (See Sections 12.1 thru 12.7 of the
Michigan Title X Family Planning Standards and Guidelines Manual).
A. Provide a brief description of the I&E Committee’s function.
B. Include the current fiscal year’s meeting schedule and the member roster as an
attachment. The roster should indicate what community populations/groups the
member represents (e.g., agency or professional organization name, or teen, male,
client, or parent).
C. Describe the I&E Committee’s review and approval process for educational
materials, including review tools used, how reviewer feedback is gathered, and
how member determinations are documented.
VII. Progress Report on Additional FY 2017 Title X Funds for Priority Projects t
A. Provide a brief progress report on the agency’s Priority Projects goals, objectives,
and activities using the Quality Family Planning Service Project Progress Report
(See Family Planning website, ‘Information for Providers’). NOTE: Each agency
received $20,000 for a Priority Project 2017.
57
B. Provide a brief progress report on the agency’s Third Party Payer Outreach
project goals, objectives and activities using the Quality Family Planning Service
Project Progress Report (See Family Planning website, ‘Information for
Providers’) if your agency applied for the additional $3,000 in funding.
VIII. Electronic Health Records/Electronic Medical Record (EHR/EMR)
A. Provide the name and version of your EHR/EMR system along with the following
details:
i. Does your medical director utilize the EHR/EMR during the quality
assurance process?
ii. Do you currently utilize your EHR/EMR to manage program inventory?
IX. Third Party Agreements
A. Please list all contracted third-party payers (Medicaid Health Plans or Private
Payers) enjoined by your agency.
Financial Management Audit Requirements
Financial Management Audit Requirements
Following are the Audits that are required of all Family Planning Title X sub-recipient agencies.
This section applies to agencies designated as sub-recipients (health department & private non-
profit agencies.) Grantees designated as vendors are exempt from the provisions of this section.
1. Required Audit or Exemption Notice
Grantees must submit to the Department a Single Audit, or Exemption Notice as described below
(A. - B.). If submitting a Single Audit, Grantees must also submit a Corrective Action Plan for
any audit findings that impact MDHHS-funded programs and management letter (if issued) with
a response.
A. Single Audit
Grantees that are a state, local government or non-profit organization that expend $750,000 or
more in federal awards during the Grantee’s fiscal year must submit a Single Audit to the
Department, regardless of the amount of funding received from the Department. The Single
Audit must comply with the requirements of the Single Audit Act Amendments of 1996, and
Title 2 Code of Federal Regulations, Subpart F.
B. Audit Exemption Notice
Grantees exempt from Single Audit must submit an Audit Exemption Notice that certifies the
exemption. The template Audit Exemption Notice and further instructions are available at
http://www.michigan.gov/mdhhs by selecting Inside MDHHS – MDHHS Audit – Audit
Reporting.
58
2. Other Audits
The Department or federal agencies may also conduct or arrange for additional audits to meet
their needs. In addition to the above audits, comprehensive site reviews are performed every
three years, and detailed fiscal reviews are performed every two to three years. If any concerns
are noted, a corrective action plan is expected. Revisits occur as deemed necessary.
3. Due Date and Where to Send
The required audit and any other required submissions (i.e. Corrective Action Plan and
management letter with a response), or Audit Exemption Notice must be submitted to the
Department within nine months after the end of the Grantee’s fiscal year by e-mail to the
Department at MDHHS[email protected]. The required materials must be
assembled in a PDF file compatible with Adobe Acrobat (read only). The subject line must state
the agency name and fiscal year end. The Department reserves the right to request a hard copy
of the audit materials if for any reason the electronic submission process is not successful.
4. Penalty
A. Delinquent Single Audit
If the Grantee does not submit the required Single Audit, including any management letter with a
response and applicable Corrective Action Plan within nine months after the end of the Grantee’s
fiscal year, the Department may withhold from the current funding an amount equal to five
percent of the audit year’s grant funding (not to exceed $200,000) until the required filing is
received by the Department. The Department may retain the amount withheld if the Grantee is
more than 120 days delinquent in meeting the filing requirements. The Department may
terminate the current grant if the Grantee is more than 180 days delinquent in meeting the filing
requirements.
B. Delinquent Audit Exemption Notice
Failure to submit the Audit Exemption Notice, when required, may result in withholding from
the current funding an amount equal to one percent of the audit year’s grant funding until the
Audit Exemption Notice is received.
5. Management Decision
The Department shall issue a management decision on findings and questioned costs contained
in the Grantee’s Single Audit within six months after the receipt of a complete and final audit
report. The management decision includes whether or not the audit finding is sustained; the
reasons for the decision; and the expected Grantee action to repay disallowed costs, make
financial adjustments, or take other action. Prior to issuing the management decision, the
Department may request additional information or documentation from the Grantee, including a
request for auditor verification of documentation, as a way of mitigating disallowed costs.
59
SECTION II
Administrative Program
Requirements for Title X Family
Planning Projects
60
A. Overview of Title X Program Requirements
The MDHHS Title X Family Planning Program Standards and Guidelines align with the Office
of Population Affairs (OPA) Title X Family Planning Guidelines published in April, 2014
which replace the 2001 Program Guidelines for Project Grants for Family Planning Services.
The new guidelines are contained in the following two documents:
1. Program Requirements for Title X Funded Family Planning Projects. This document is
derived from the Title X statute, implementing regulations and other requirements
under Title X of the Public Health Service Act. It describes the Title X program
requirements for funded projects. http://www.hhs.gov/opa/sites/default/files/ogc-
cleared-final-april.pdf
2. Providing Quality Family Planning Services (QFP) was developed jointly by the
Centers for Disease Control and Prevention (CDC) and OPA and published as a CDC
MMWR Recommendations and Reports. The QFP presents clinical recommendations
for providing family planning services consistent with the best available scientific
evidence. The QFP is intended for providers across all practice settings and serves as
the clinical guidance for Title X projects. http://www.cdc.gov/mmwr/pdf/rr/rr6304.pdf
The Administrative Program Requirements section of the MDHHS Title X Family Planning
Standards and Guidelines Manual, 2014 focus on the requirements outlined in the Program
Requirements for Title X Funded Family Planning Projects and defines administrative
requirements for MDHHS Family Planning programs. The Clinical Services section follows the
outline and recommendations in the QFP and defines clinical requirements for MDHHS Family
Planning programs.
B. Eligibility, Application and Grant Process
1. APPLICABILITY
The requirements set forth in this document apply to the award of grants to MDHHS
Title X sub-recipients under the MDHHS grant awarded under section 1001 of the PHS
Act (42 U.S.C. 300) to assist in the establishment and operation of voluntary family
planning projects in Michigan. These projects consist of the educational, comprehensive
medical, and social services necessary to assist individuals to determine freely the
number and spacing of their children.
61
2. DEFINITIONS
Terms used throughout this document include:
TERM
DEFINITION
The Act or Law
Title X of the Public Health Service Act, as amended
Annual
Requirements
Where this manual requires activities to
be carried out annually, they
must be conducted within a 12 month period.
Family
A social unit composed of one person, or two or more persons
living together, as a household
Low-income family
A family whose total annual income does not exceed 100% of the
most recent Federal Poverty Guidelines; also includes members of
families whose annual family income exceeds this amount, but who,
as determined by the project director, are unable, for good reasons, to
pay for family planning services. Un-emancipated minors who wish
to receive services on a confidential basis must be considered on the
basis of their own resources.
Grantee
MDHHS is the grantee that receives Title X funding for the state of
Michigan and assumes legal and financial responsibility and
accountability for performance of approved activities under the
grant.
Sub-recipients
Those entities that provide family planning services with Title X fun
ds
under a written agreement with a grantee. May also be referred to as
delegates or contract agencies.
Service Site
The clinics or other locations where services are provided by
the grantee or sub-recipient.
Project
Activities described in the grant and supported under the approved
budget. The “scope of the project” as defined in the funded
application consists of activities that the approved Title X family
planning project budget supports.
Nonprofit
A private agency, institution, or organization for which no part of the
entity’s net earnings benefit, or may lawfully benefit, any private
stakeholder or individual.
Must
Throughout this document, the words must or required indicate
mandatory program requirements.
Should
The word should, as used in this document, indicates recommended
program guidelines and policies that reflect current standards of
practice and are strongly recommended by MDHHS in order to fulfill
the intent of Title X.
62
May
The words can or may
, as used in this document, indicate suggestions
for consideration by individual projects.
Minors
The term Minors
refers to clients under the age of 18 and is used with
reference to legal/statutory mandates regarding provision of services,
confidentiality, required counseling, protections, and legal
requirements for mandatory reporting of suspected abuse of minors.
Provider
The term provider refers to any staff member who is involved in
providing family planning services to a client; includes physicians,
physician assistants, nurse practitioners, nurse-midwives, nursing
staff and other staff providing client services. (QFP p.4)
Family Planning
Services
The QFP defines family planning services within a broader
framework of preventive health services. Family Planning Services
include: contraceptive services for clients who want to prevent
pregnancy and space births; pregnancy testing and counseling;
assistance to achieve pregnancy; basic infertility services; STD
services (including HIV/AIDS); and preconception health services.
(QFP p.4) They are considered musts for family planning programs.
Related Preventive
Health Services
Related Preventive Health Services include services that are
considered beneficial to reproductive health, linked to family planning
services, and appropriate to deliver within a family planning visit
(e.g., breast and cervical cancer screening) (QFP p.5) They are
considered musts for family planning programs.
Other Preventive
Health Services
Other Preventive Health Services
include preventive health services
for women and women not linked to reproductive health (e.g.,
screening for lipid disorders, skin cancer, colorectal cancer or
osteoporosis.) These services are beyond the scope of family
planning
but should be available either on-site or referral to appropriate
providers. (QFP p.5) Family programs must have appropriate unpaid
referral sources for these services.
Family Planning
Encounter
A family planning encounter is a face-to-face contact between a
client and family planning provider. The purpose of a family planning
encounter is to provide family planning and related preventive health
services to clients who want to prevent, space or achieve healthy
pregnancies or want family planning advice, education or counseling.
For purposes of FPAR, the encounter must take place in a Title X
service site and must be documented in the client record. (Title X
FPAR Forms & Instructions, 2016, page 7,8)
63
Family Planning
Provider
The term family planning provider refers to any staff member
involved in providing family planning services to a client; includes
physicians, physician assistants, nurse practitioners, nurse-midwives,
nursing staff and other staff providing client services. (QFP p.4). For
purposes of FPAR, Clinical Services Providers include: physicians,
physician assistants, nurse practitioners, and certified nurse midwives;
and Other Services Providers include: licensed nurses, nurse
assistants, laboratory assistants, health educators, social workers, or
clinic aids providing family planning services. (Title X FPAR Forms
& Instructions, 2016, page 7)
Family Planning
Service Site
The term service site
refers to clinics or other locations where Title X
family planning services are provided by the grantee or sub-recipient.
(Title X FPAR Forms & Instructions, 2016, page 8)
Family Planning
Client or User
The term family planning client refers to an individual of
reproductive age who is in need of family planning and related
preventive health services. (QFP, page 2) For purposes of FPAR, a
family planning user is an individual who has at least one family
planning encounter at a Title X family planning service site during the
reporting period. (Title X FPAR Forms & Instructions, 2016, page 7)
MCIR
The Michigan Care Improvement Registry (MCIR) is Michigan’s
online immunization registry.
Risk Assessment
The term Risk Assessment as used in this document, means an
objective identification of risk behaviors and situations that may lead
to recognized adverse health conditions. Risk assessment leads to
screening recommendations, appropriate interventions, or treatment.
Screening
The term Screening, as used in this document, means testing to
identify an unrecognized disease or health condition to enable early
intervention and management. Screening initiatives help lead to
earlier diagnosis to reduce mortality and suffering from diseases.
3. ELIGIBILITY
Any public or nonprofit private entity located in Michigan is eligible to apply for a Title X
family planning services project grant through MDHHS as the Title X Grantee for Michigan.
A. Eligible applicants must demonstrate past experience delivering primary care, adolescent
or women’s health care or family planning services. Potential applicants include:
1. Public and private non-profit health agencies
2. Local health departments
3. Community health centers
64
4. Federally Qualified Health Centers
5. Rural and Urban Health Centers
6. Tribal Indian health centers
7. Faith based organizations
B. Entities must furnish evidence of non-profit status in accordance with instructions
accompanying the project grant application.
C. Applicants must have providers who are or can become Medicaid enrolled providers as
well as bill private third-party payers.
D. Eligible applicants providing services beyond the Title X family planning program must
ensure that Title X funds will be expended solely for the Title X program under the terms
and conditions of the grant.
E. Eligible applicants must demonstrate and assure ability to meet program requirements set
forth by the Title X statute, OPA Title X regulations and MDHHS Family Planning
Minimum Program Requirements.
F. Applicants must have the capacity to provide a broad range of family planning methods.
Grants cannot be made to entities that propose to offer only a single method or unduly
limited number of family planning methods. An organization offering a single or limited
number of family planning methods may receive Title X assistance only by participating
as a special service with a formal agreement in place with a project offering a broad range
of family planning services.
G. The organization must have a governing board that is representative of the community or
have a program specific family planning advisory council representative of the
community.
H. Local health departments have the primary responsibility to meet the health needs of
vulnerable populations but may elect not to provide family planning services directly.
(Public Health Code, 2000: Section 333.2473).
I. Pursuant to PA 360 (2002) Section 333.1091, MDHHS must give priority in the
allocation of funds within a service area where there are competing qualified applicants
to qualified entities that do not engage in performing elective abortions within a facility
owned or operated by the entity; do not maintain a policy that considers elective abortion
part of a continuum of family planning or reproductive health services; and/or is not
affiliated with another entity that engages in providing abortion services. (Section I, page
42)
4. APPLICATION
The Michigan Department Health and Human Services receives funds from the Department
of Health and Human Services' Office of Population Affairs to administer the Title X Family
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Planning Program in Michigan. MDHHS conducts a competitive bid process available to any
public or nonprofit entity interested in providing Title X family planning services in
Michigan. Applicants must submit a competitive bid application as set forth by MDHHS.
Applicants must follow the format and content as detailed in the competitive bid guidance.
The application and technical assistance are available from the MDHHS. The grant
application covers at least a three-year period.
Annually, agencies awarded Title X funding in the competitive bid process must submit an
application for continuing grantee sub-recipient status which includes a needs assessment and
an annual health care plan. These annual plans must be submitted to MDHHS and follow
the guidance provided by MDHHS (See the Michigan Family Planning Information in
Section I of this document for details). Technical assistance is available. The plan must not
include activities that cannot be funded under Title X, such as abortion or lobbying activities.
5. FUNDING
Funding support for the Michigan Title X Family Planning Program include the Title X Federal
grant, State of Michigan appropriations, revenue from first and third-party collections and
donations. Annually, the Federal grant award and State appropriations are determined, and funds
are distributed to sub recipients based on a funding formula.
Title X funds support local infrastructures to deliver family planning services with a priority
focus on the low-income population with the greatest need. The proxy for the population in need
is women 15-44 years old at or below 100% of the Federal Poverty Level. Each county has 1) an
estimated caseload of Title X users (clients) for which a $183 per user is allocated; and 2) the
total amount of funding available.
A
wardees are selected for a minimum three-year funding cycle (with the potential to extend one
or more additional cycles). The initial annual agreement covers the Fiscal Year of the funding
cycle, Michigan Department of Health and Human Services contract year. Awardees in good
standing and who meet all minimum requirements will maintain sub recipient status at least
through the three-year funding cycle, depending on the availability of funds.
I
n subsequent years, sub recipients must submit a non-competitive annual plan. Each year
continuing funding is contingent upon the availability of funds; timely, accurate submission of
reports; an approved annual plan; satisfactory progress toward completion of the current year’s
contract objectives and meeting family planning’s Minimum Program Requirements and
Reporting Requirements.
I
n addition to the grant awards, sub recipients receive separate supplemental support in the form
of bulk purchase condoms and laboratory testing services for Chlamydia and Gonorrhea via the
MDHHS Laboratory. Colposcopy services are provided through MDHHS’s Breast and Cervical
Cancer Control Program (BCCCP).
D
ue to funding dependent upon Federal and State appropriations, allocations may vary and are
subject to change.
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Any change in scope of services provided by the sub-recipient, including expanding or reducing
services or the service area, must be approved by MDHHS prior to implementation.
6. N
OTICE OF AWARD
The notice of funding award will inform the MDHHS Title X sub-recipient of the initial year
allocation based on the annual appropriation and minimum caseload supported by the
allocation. Notices will identify the Michigan county/counties for which funding is
appropriated and will identify any conditions of funding not addressed in the application. The
project period between competitive bids is at least three years. The project is funded in
budget periods, normally twelve months, based on the legislative appropriation process.
7. USE OF GRANT FUNDS
All funds granted for Title X family planning services projects must be expended only for
the purpose for which the funds were awarded and in accordance with the approved
application and budget. Funds may not be used for prohibited activities, such as abortion as
a method of family planning, or lobbying. Funds must be used in accordance with the Title
X family planning services projects regulations, MDHHS annual contract, and HHS grants
administration regulations. HHS grants administration regulations can be accessed in the
HHS Grants Policy Statement, 2007 (Section I, page 34)
C. Project Management and Administration
8. PROJECT MANAGEMENT AND ADMINISTRATION
All sub-recipient agencies receiving Title X finds must provide high quality family
planning services which are competently and efficiently administered.
A. Sub-recipient agencies must have written policies and operating procedures in place to
meet the standards of the legal issues described in Section 8.1 through 8.7
8.1 Voluntary Participation
Family planning services must be provided solely on a voluntary basis (Sections 1001 and
1007, PHS Act; 42 CFR 59.5 (a) (2)).
i. Clients must not be coerced to accept services or to use or not use any particular
method of family planning (42 CFR 59.5 (a) (2)).
ii. A client’s acceptance of family planning services must not be a prerequisite to
eligibility for, or receipt of, any other services, assistance from, or participation in any
other program that is offered by the grantee or sub-recipient (Section 1007, PHS Act; 42
CFR 59.5 (a)(2)).
iii. Personnel working within the family planning project must be informed that they may
be subject to prosecution if they coerce or try to coerce any person to undergo an
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abortion or sterilization procedure (Section 205, Public Law 94-63, as set out in 42
CFR 59.5(a)(2) footnote 1).
iv. Sub-recipients must assure in their general consent for services that family planning
services are provided on a voluntary basis, without coercion to accept services or any
particular method of family planning and without prerequisite to accept any other
service.
8.2 Prohibition of Abortion
Title X grantees and sub-recipients must be in full compliance with Section 1008 of the Title
X statute and 42 CFR 59.5(a)(5), which prohibit abortion as a method of family planning.
A. Sub-recipients must have written policies that clearly indicate that no Title X funds
will be used in programs where abortion is a method of family planning.
B. Additional guidance on this topic can be found in the July 3, 2000, Federal Register
Notice entitled Provision of Abortion-Related Services in Family Planning Services
Projects, 65 Fed. Reg. 41281 and the final rule entitled Standards of Compliance for
Abortion-Related Services in Family Planning Services Projects, 65 Fed. Reg. 41270.
(Section I, page 23).
8.3 Structure and Management
Family planning services under the MDHHS Title X grant are provided by sub- recipient
agencies operating under the umbrella of the MDHHS Title X Family Planning Program. As
the grantee, MDHHS is accountable for the quality, cost, accessibility, acceptability,
reporting, and performance of the grant-funded activities provided by sub-recipients.
8.3.1 As the grantee, MDHHS must have a written contract with each sub-recipient and
must maintain and provide updated MDHHS Title X Family Planning Standards and
Guidelines Manual for sub-recipient agencies consistent with Title X Program
Requirements and other applicable requirements (45 CFR parts 74 and 92).
Sub-recipient agencies must have an updated copy of the MDHHS Standards and
Guidelines available at each service site.
MDHHS must perform a comprehensive program review of each sub-recipient agency
a minimum of every three years and is responsible for providing technical assistance
and consultation as needed to ensure that agencies are in compliance.
8.3.2 Where a sub-recipient agency wishes to subcontract any of its responsibilities or
services, a written agreement that is consistent with Title X Program Requirements
must be in place and must be approved by MDHHS. Sub-recipients must identify
subcontracted responsibilities or services in their annual plan. (45CFR parts 74 and
92).
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8.3.3 All services purchased for project participants must be authorized by the project
director or his/her designee on the project staff (42 CFR 59.5(b) (7)).
8.3.4 Where required services are provided by referral, the sub-recipient must have written
agreements for the provision of services and reimbursement of costs as appropriate.
Services provided through a contract/arrangement must be paid for under agreements
that include a reasonable schedule of rates. (42 CFR 59.5(b) (9)).
8.3.5 Sub-recipient agencies must be given an opportunity to participate in the establishment
of MDHHS policies and guidelines (42 CFR 59.5 (a) (10)).
8.3.6. Sub-recipient agencies must maintain a financial management system that meets Federal
standards, as applicable, requirements in the contract, and which complies with Federal
standards that support effective control and accountability of funds. Documentation
and records of all income and expenditures must be maintained. (2 CFR Part 200)
8.3.7. Sub-recipient agencies must adhere to MDHHS Title X reporting requirements
(MRR). (Section I, pages 52,53)
A. Mid-Year and End-Year Family Planning Annual Report (FPAR)
B. Family Planning Needs Assessment and Health Care Plan (Annual Plan)
C. Sub-recipients must have written policies and procedures for mandatory
reporting of child abuse and neglect, sexual abuse, as well as compliance with
human trafficking laws.
8.4 Charges, Billing, and Collections
The sub-recipient must have written policies and procedures for charging, billing, and
collecting funds for the services provided by the project that meet Title X requirements:
Clients must not be denied services or be subjected to any variation in quality of services
because of inability to pay.
Sub recipients must develop a schedule of discounts (sliding fee schedule) to assure that
clients are charged based on ability to pay, (42 CFR 59.5(a) (8)). Ability to pay is determined
by assessing family income using the most current Federal Poverty Level (FPL) guidelines.
A. Individual eligibility for a discount must be documented in the client's record/file.
Client income should be re-evaluated at least annually.
B. Projects must rely on client self-report when assessing client income directly.
However, Title X regulations allow grantees discretion to use income verification
data provided by clients because of participation in other programs operated by the
organization. Projects that have access to income verification data because of a
client’s participation in another program may use that data rather than rely solely on
client self-report.
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C. MDHHS policy requires that the schedule of discounts must be developed with
sufficient proportional increments to assure services are billed based on ability to pay.
Sub-recipients must use the mandated quartile proportional increments that MDHHS
distributes each year in developing their schedule of discounts. Sub-recipients may
request and must receive an MDHHS approved waiver to use other proportional
increments.
8.4.1 Clients whose documented income is at or below 100% of FPL must not be charged,
although projects must bill all third parties authorized or legally obligated to pay for
services (Section 1006(c)(2), PHS Act; 42 CFR 59.5(a)(7)).
8.4.2 Clients whose family income falls between 101% and 250% of the FPL must be
charged based on the schedule of discounts developed to assure that services are billed
based on ability to pay, (42 CFR 59.5(a) (8)).
8.4.3 Fees must be waived for individuals with family incomes above 100% of the FPL
who, as determined by the service site project director, are unable, for good cause, to
pay for family planning services (42 CFR 59.2). Approval of waived fees for good
cause must be documented in the client record.
8.4.4 Clients whose family income exceeds 250% of the FPL must be charged based on a fee
schedule designed to recover the reasonable cost of providing services. (42 CFR
59.5(a) (8)). Sub-recipients must document their process for developing the fee
schedule to indicate how they determined reasonable costs to be recovered. The
documented process must include an analysis of the costs of providing services and
identification of other factors used to determine the fee schedule. Sub-recipients may
elect to set their fee schedule below what would recover the actual cost of providing
services, based on their specific community needs and circumstances. Sub-recipients
must review their program costs and reassess their fee schedule at least every two years
and are encouraged to do so annually. Sub-recipients must use the cost analysis tool
developed by MDHHS Family Planning Program, unless they request and receive a
waiver to use another methodology to assess program costs.
8.4.5 Eligibility for discounts for minors who receive confidential services must be based on
the income of the minor (42 CFR 59.2).
A. Sub-recipients must not have a policy of no fees or flat fees for the provision of
services to minors and must not have a fee schedule for minors that are different
from the fee schedule for other populations receiving family planning services.
8.4.6 Where there is legal obligation or authorization for third party reimbursement, including
public or private sources, all reasonable efforts must be made to obtain third party
payment without the application of any discounts (42 CFR 59.5(a)(9)).
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A. With regard to insured clients, family income must be considered before
determining whether copayments or additional fees are charged. Clients whose
family income is at or below 250% FPL must not pay more (in copayments or
additional fees) than what they would otherwise pay when the schedule of
discounts is applied.
8.4.7 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 sub-recipient agency is required (42 CFR 59.5(a)(9)]
8.4.8 Reasonable efforts to collect charges without jeopardizing client confidentiality must be
made.
A. At the time of services, clients who are responsible for paying any fee for their
services should be offered bills directly. Bills to clients should show total charges
less any allowable discounts. Sub recipients must have the capacity to provide a bill
to clients who request a bill.
B. Sub-recipients must have a method for the "aging" of outstanding accounts. The
agency’s written policies on billing and collections must include the policy on aging
accounts and writing off outstanding accounts.
8.4.9 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.
8.5 Project Personnel
Title X projects must have approved personnel policies and procedures.
8.5.1 Sub-recipient agencies must 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, Title I of the Americans with Disabilities
Act, and the annual appropriations language. These policies should include, but are not to
be limited to, staff recruitment, selection, performance evaluation, promotion,
termination, compensation, benefits, and grievance procedures.
A. Personnel records must be kept confidential.
B. Performance evaluations of program staff must be conducted according to the
agency personnel policy.
C. Organizational chart and personnel policies must be available to all personnel.
D. Job descriptions must be available for all positions and updated as needed.
8.5.2 Family Planning staff should be broadly representative of significant elements of the
population to be served by the project, and must be sensitive to, and able to deal
effectively with, the cultural and other characteristics of the client population (42 CFR
59.5 (b)(10)).
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8.5.3 Family Planning projects must be administered by a qualified project director/family
planning coordinator. Family Planning directors/coordinators must be familiar with
the MDHHS Family Planning Standards and Review Manual, the Title X statute and
regulations. Sub-recipients must notify MDHHS of change or extended absence of the
project director/family planning coordinator, or significant change in project
personnel to assure ongoing communication and coordination of the Family Planning
Program.
8.5.4 Family Planning projects must provide medical services under the supervision of a
physician/medical director with special training or experience in family planning (42
CFR 59.5 (b) (6).
A. Michigan’s pharmacy law requires that the physician who has responsibility for
the dispensing of prescription medications at a service site have a Drug Control
License delegating authority to dispense prescription drugs. This dispensing
license is in addition to the medical license required for writing prescriptions.
Sub-recipients must have in place a drug control license for each location in
which the storage and dispensing of prescription drugs occur, in compliance with
Act 368 of 1978 sec 333.17745 and 333.17745a. (Section I, pages 42, 43-44)
Providers other than physicians performing medical functions must do so under
protocols and/or standing orders approved by the medical director.
A. Physical assessment, diagnosis, treatment, and provision of medication and devices
must be performed by a physician or licensed certified mid-level clinician. These
mid-level clinicians include nurse practitioners, certified nurse midwives, and
physician assistants.
B. All mid-level practitioners must maintain current licensure and certification by the
standards defined by Public Act 368 of 1978 as amended, Part 4, R338.10406, as
defined by the Michigan Department of Licensing and Regulation, Board of
Nursing, in the General Rules, or by the Council of Allied Health Education (for the
Certification of Physician Assistants); and that other health professionals and para-
professionals may be utilized to perform non-medical responsibilities, or assist in
medical functions as approved by the medical director.
8.5.5 Appropriate salary limits apply as required by law. Salary limitations are identified
in the Title X Notice of Award, reflecting the current federal appropriations law.
8.6 Staff Training and Project Technical Assistance
Title X grantees are responsible for the training of all project staff.
8.6.1 Sub-recipients must provide for the orientation and in-service training of all project
personnel, including the staff of sub-recipient agencies and service sites (42 CFR
59.5(b)(4)) and should provide periodic staff meetings to review program activities.
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A. Sub-recipients should document attendance at training and continuing education
programs.
B. All staff should be offered the opportunity to attend/access training programs,
particularly National Training Center (NTC) programs, MDHHS training
programs, and the annual Family Planning Update at least once per year.
C. Funds for training and continuing education should be included in each year’s
operating budget.
D. Registered nurses and mid-level practitioners should be offered appropriate
educational opportunities so as to comply with requirements of the
licensure/certification process.
E. Sub-recipients are encouraged to participate in the training needs assessment
developed by MDHHS and MPHI to assist MDHHS in planning future training
programs and determining changes needed in established training programs.
F. Sub-recipients should have appropriate clinical resource books available for staff
such as: CDC Providing Quality Family Planning Services Recommendations of
CDC and OPA; CDC U.S. Selected Practice Recommendations for Contraceptive
Use, 2016 (SPR); Contraceptive Technology, 20
th
edition; and CDC, United
States Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2016.
8.6.2 Staff must be trained on mandatory reporting requirements for child abuse, child
molestation, sexual abuse, rape or incest, and on human trafficking at least every two
years.
8.6.3 Staff must be trained on encouraging family involvement in the decision of minors to
seek family planning services and on counseling minors on how to resist being coerced
into engaging in sexual activities at least every two years.
8.6.4 Staff must be trained regarding prevention, transmission and infection control in the
health care setting of sexually transmitted infections including HIV as required by
OSHA regulations.
8.6.5 Staff must be trained and understand their role in an emergency or natural disaster as
required by OSHA regulations.
8. 6.6 Staff must be trained in the unique social practices, customs and beliefs of under-
served populations of their service area at least every two years.
8.6.7 Clinical staff involved in dispensing medications must be trained regarding the nature
and safety of pharmaceuticals dispensed in the clinic at least every two years.
8.7 Planning and Evaluation
MDHHS must ensure that the project is competently and efficiently administered (42 CFR 59.5
(b) (6) and (7)). In order to adequately plan and evaluate program activities, MDHHS develops
written goals and objectives for the year, project period, that are specific, measurable,
achievable, realistic, time-framed, consistent with Title X Program Requirements, and based on
a needs assessment.
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A. Sub-recipient agencies must submit written goals and objectives (Family Planning
Work Plan) for the year with their annual plans that are specific, measurable,
achievable, time-framed and consistent with Title X Program requirements as part
of their annual plan. Objectives must include an evaluation component. Instructions
for the annual plan and work plan are available in the Michigan Information in
Section I of this document and are emailed to Family Planning Coordinators
annually. Templates for the Family Planning Program Work Plan are available on
the MDHHS Family Planning website at: www.michigan.gov/familyplanning.
9. PROJECT SERVICES AND CLIENTS
Projects funded under Title X are intended to enable all persons who want to obtain family
planning care to have access to such services. Projects must provide for comprehensive
medical, informational, educational, social, and referral services related to family planning for
clients who want such services. Sub-recipients must have written policies and procedures in
place to assure the following:
9.1 Priority for project services must be to persons from low- income families (Section
1006(c) (1), PHS Act; 42 CFR 59.5(a) (6)).
9.2 Services must be provided in a manner which protects the dignity of the individual (42
CFR 59.5 (a) (3)).
9.3 Services must be provided without regard to religion, race, color, national origin, creed,
handicap, sex, number of pregnancies, marital status, age, sexual orientation, and
contraceptive preference. (42 CFR 59.5 (a) (4)).
9.4 Projects must provide for social services related to family planning including counseling,
referral to and from other social and medical services agencies, and any ancillary services
which may be necessary to facilitate clinic attendance (42 CFR 59.5 (b)(2)).
9.5 Projects must provide for coordination and use of referral arrangements with other
providers of health care services, local health and welfare departments, hospitals,
voluntary agencies, and health services projects supported by other federal programs (42
CFR 59.5 (b)(8).
9.6 All family planning services must be provided using written clinical protocols that are in
accordance with nationally recognized standards of care, signed by the medical director
responsible for program medical services. MDHHS will review protocols at the
comprehensive program review.
9.7 All projects must provide for medical services related to family planning and the
effective usage of contraceptive devices and practices (including physician’s
consultation, examination, prescription, and continuing supervision, laboratory
examination, contraceptive supplies) as well as necessary referrals to other medical
facilities when medically indicated (42 CFR 59.5(b)(1)).
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A. Necessary referrals include but are not limited to emergencies that require referral.
Efforts may be made to aid the client in finding potential resources for
reimbursing the referral provider, but projects are not responsible for the cost of
this care.
9.8 All projects must provide 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). A service site that offers
only a single or very limited number of family planning methods may participate only as
part of a project where the entire project offers a broad range of family planning
services. MDHHS must be informed of these arrangements. (42 CFR 59.5(a) (1)).
9.9 Services must be provided without the imposition of any residency requirement or
requirement that the client be referred by a physician (42 CFR 59.5(b) (5)).
9.10 Projects must provide pregnancy diagnosis and counseling to all clients in need of this
service (42 CFR 59.5(a) (5)).
9.11 Projects must offer pregnant women the opportunity to be provided information and
counseling regarding each of the following options:
A. Prenatal care and delivery;
B. Infant care, foster care, or adoption; and
C. Pregnancy termination.
If requested to provide such information and counseling, projects must provide neutral,
factual information and nondirective counseling on each of the options, and referral
upon request, except with respect to any options(s) about which the pregnant woman
indicates she does not wish to receive such information and counseling (42 CFR
59.5(a)(5)).
9.12 Sub-recipient agencies must comply with applicable legislative mandates set out in the
HHS appropriations act. Grantees must have written policies in place that address these
legislative mandates:
A. Projects must encourage family participation in the decision of minors to seek
family planning services and must provide counseling to minors on how to resist
efforts to coerce the minor into engaging in sexual activities.
B. Projects must comply with state laws requiring notification or reporting of child
abuse, child molestation, sexual abuse, rape, or incest. No provider of services
under Title X is exempt from any laws requiring mandatory reporting.
10. CONFIDENTIALITY
Every project must have policies, procedures, and safeguards in place to ensure client
confidentiality.
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10.1 Safeguards to ensure confidentiality must include:
A. Assurance of confidentiality included in agency policies and procedures.
B. A confidentiality assurance statement in the medical record, such as in the general
consent for services.
C. A confidentiality assurance statement signed by all family planning project personnel.
D. Title X projects must not require written consent of parents of guardians for the
provision of services to minors; nor can Title X staff notify a parent or guardian before
or after a minor has received title X family planning services.
.
10.2 Information obtained by the project staff about an individual receiving services must
not be disclosed without the individual’s documented consent, except as required by
law or as may be necessary to provide services to the individual, with appropriate
safeguards for confidentiality.
10.3 Information regarding clients and services must otherwise be disclosed only in summary,
statistical, or other form that does not identify the individual (42 CFR 59.11).
10.4 Confidentiality under Title X must not be invoked to circumvent mandated reporting
requirements for child abuse and neglect.
10.5. Efforts should be made to assure that written and verbal exchanges between clients and
clinic/clerical staff kept private, so that other clients in the site do not know client
identity or reason for the visit.
11. COMMUNITY PARTICIPATION, EDUCATION, AND PROJECT PROMOTION
Title X grantees are expected to provide for community participation and education
and to promote the activities of the project.
11.1 Title X grantees and sub-recipient agencies must provide an opportunity for
participation in the development, implementation, and evaluation of the project by
persons broadly representative of all significant elements of the population to be
served; and by persons in the community knowledgeable about the community’s
needs for family planning services (42 CFR 59.5(b)(10)).
A. Sub-recipient agencies must fulfill this requirement using a governing board,
program specific family planning advisory committee (FPAC), or other
appropriate advisory group which reviews general program/policy issues and make
recommendations to the agency on organization, management and operation of the
Family Planning Program.
1. The composition of the board or advisory committee must be broadly
representative of the population served in the community and include persons
knowledgeable about family planning.
2. Each group must meet at least once a year to:
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a. Review the agency’s program plan, assess accomplishments and suggest
future program goals and objectives.
b. Review the agency’s progress toward meeting the needs population in the
service area and maintaining services and policies responsive to the needs
of the community.
c. The FPAC or advisory group, or a subcommittee of the FPAC or advisory
group, may also serve the function of the Information and Education (I. &
E.) Advisory Committee, so long as requirements of sections 12.1-12.7 are
met.
3. Minutes must be kept of all meetings.
4. Meetings may be conducted utilizing electronic technology.
B. Other recommendations for community participation include the following:
1. Use of client satisfaction surveys.
2. Inclusion of teens and low-income women on the Advisory Council.
3. Asking for client input on educational and informational materials.
4. Use of client surveys or focus groups designed to elicit what services may be
seen as needed by clients but not available.
11.2 Projects must establish and implement planned activities to facilitate community
awareness of and access to family planning services (42 CFR 59.5(b) (3)). Each family
planning project must provide for community education programs (42 CFR 59.5(b)
(3)). Community education program(s) should be based on an assessment of the needs
of the community and should contain an implementation and evaluation strategy.
11.3 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 (42 CFR 59.5 (b)(3).
12. APPROVAL OF INFORMATION AND EDUCATION MATERIALS
Sub-recipient agencies are responsible to maintain an Information and Education (I. & E.)
Advisory Committee that follows Title X requirements for the review and approval of educational
materials. The requirements of the I. & E. committee are as follows:
12.1 Every sub-recipient agency must have a review and approval process of 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 (Section 1006(d) (1), PHS Act; 42 CFR 59.6(a)).
The I. & E. Committee may also serve the community participation functions of a family
planning advisory committee (FPAC) or advisory group described above in section
11.1.A, as long as it meets the requirements of both groups.
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12.2 I. & E. Committee membership must include individuals broadly representative (in
terms of demographic factors such as race, color, national origin, handicapped
condition, sex, and age) of the population or community for which the materials are
intended (42 CFR 59.6 (b) (2)).
A. Family Planning Program staff may provide administrative and clinical support
to the committee but may not be voting members of the advisory committee.
B. The committee may include professionals who work directly with population
groups for which materials are intended, but the priority should be to include
client and community members where possible.
C. The agency must demonstrate efforts to recruit client and community members
to assure broad representation the populations served. See “Information &
Education Committee Member Recruitment Tips and Resources” at:
www.michigan.gov/familyplanning.
D. The description of I. &. E. Committee composition submitted to MDHHS with
the Annual Plan must include how the composition represents the populations
served in terms of demographic factors such as race, color, national origin,
handicapped conditions, sex, and age.
E. The I. & E. Committee roster submitted to MDHHS with the Annual Plan must
identify what community populations/groups the member represents (e.g.,
agency or professional organization name, or teen, male, client, or parent).
12.3 The sub-recipient agency I. & E. Committee must be made up of five to nine members,
except that this size provision may be waived by the Office of Population Affairs
(OPA) where a good cause has been shown (42 CFR 59.6(b)(1)).
A. If an agency wishes to request a waiver to the five to nine membership
requirement, a written request indicating the good cause reasons must be
submitted to the MDHHS Family Planning Program consultant for MDHHS
review and submission to OPA for approval.
12.4 MDHHS delegates the I. & E. materials review and approval process to the sub-
recipient agencies; however, the oversight responsibility of the I. & E. review process
rests with MDHHS as the grantee. MDHHS monitors this committee and review
process with the Annual Plan review and as part of the on-site comprehensive program
review.
Each sub-recipient’s I. & E. committee must have a process for the review and approval
of materials prior to their distribution that includes the following:
A. A written description of the I. & E. Committee review and approval process
must be included in a policy statement, by-laws, or other committee documents
made available to members.
B. All new information or education materials are distributed to committee
members, along with a clinic brochure review form for each item, prior to the
committee meeting. Agencies should allow at least two weeks for members to
review materials prior to a meeting.
a. The I. & E. Committee may delegate responsibility for the review of the
factual, technical, and clinical accuracy to appropriate project staff;
78
however, final responsibility for approval of the materials rests with the
committee.
C. The I. & E. Committee must use an MDHHS approved clinic brochure review
form to document their review and individual determinations regarding approval
for each educational material.
a. An approved clinic brochure review form is located on the MDHHS
website at www.michigan.gov/familyplanning.
b. Sub-recipients wishing to modify or use a different form must submit it to
their MDHHS program consultant for approval.
D. At the I. & E. Committee meeting, members discuss their comments and
recommendations and make a determination regarding appropriateness of the
materials for the intended community or target audience.
a. In their review of materials, the committee must consider the following:
i. The educational and cultural backgrounds of the individuals the
materials are intended to serve
ii. The standards of the population or community the materials are
intended to serve
iii. Review the content to assure that the information is factually
accurate
iv. Determine whether the materials are suitable for the
population or community they are intended to serve
E. Committee approval of materials requires, at least one half of voting
members.
F. The I. & E. Committee must meet at least once a year; and should meet
as often as is needed to review and approve new materials prior to their
use. Meetings may be conducted utilizing electronic technology.
G. A written record of the determinations and approval process must be established
and maintained (Section 1006(d), PHS Act; 42 CFR59.6 (b)) including the
following:
a. Minutes must be kept of all meetings and must reflect the determination
for each item reviewed.
b. Completed review forms or a compiled summary of individual review
forms must be maintained to document member determinations.
c. A master listing of materials that have been reviewed and approved by
the committee with dates the items were approved/reapproved must be
maintained.
H. Staff overseeing the I. & E. Committee are responsible to bring existing,
previously approved, I. & E. materials for review or update on a timely basis to
assure continued accuracy and appropriateness. Previously approved materials
must be reviewed at least every three years.
12.5 Any publication or other media developed by the grantee or sub-recipient using federal
funds must acknowledge federal grant support (45CFR 74.36; 45CFR 92.34).
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13. ADDITIONAL ADMINISTRATIVE REQUIREMENTS
This section addresses additional requirements that are applicable to the Title X program and
are set out in authorities other than the Title X statute and implementing regulations.
13.1 Facilities and Accessibility of Services
Title X service sites should be geographically accessible for the population being served. Sub-
recipients are strongly encouraged to consider clients’ access to transportation, clinic locations,
hours of operation, and other factors that influence clients’ ability to access services.
Title X clinics must have written policies that are consistent with the HHS Office for Civil
Rights policy document, Guidance to Federal Financial Assistance Recipients Regarding Title
VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient
Persons (August 4, 2003) (HHS Grants Policy Statement 2007, II-23). (Section I, page 34)
A. Sub-recipient agencies must ensure meaningful access to services for persons with
limited English proficiency (LEP).
B. Sub-recipient agencies must have a written plan regarding the process for providing
language assistance to LEP clients.
C. The scope and complexity of the plan should consider the size of LEP populations likely
to be encountered and frequency of contact with the LEP populations.
D. LEP plans must include:
1. Statement of the agency’s commitment to provide meaningful access for LEP
persons.
2 Statement that services will not be denied to a client because s/he is limited English
proficient.
3. Statement that clients will not be asked or required to provide their own interpreter.
The use of family and friends as interpreters is discouraged. If the client chooses to
use family or friends, the client is informed of the right to free interpreter services
and use of family or friends occurs only after the offer is declined and documented.
4. LEP plans must include following:
a. Identify LEP individuals who need language assistance.
b. Language assistance, oral interpretation, and/or written translation
c. Staff training
d. Providing notice to LEP persons
e. Routine updating of the LEP plan
Projects must not discriminate on the basis of disability and, when viewed in their entirety,
facilities must be readily accessible to people with disabilities (45 CFR part 84) (Section I,
page 35)
13.2 Emergency Management
All grantees, sub-recipients, and Title X clinics must to have a written plan for the management
of emergencies (29 CFR 1910, subpart E), and clinic facilities must meet applicable standards
established by Federal, State, and local governments (e.g., local fire, building, and licensing
codes). (Section I, page 35)
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Health and safety issues within the facility fall under the authority of the Occupational Safety
and Health Administration (OSHA). Disaster plans and emergency exits are addressed under 29
CFR 1910, subpart E. The basic requirements of these regulations include:
A. Disaster plans (e.g. fire, bomb, terrorism, earthquake, etc.) have been developed and are
available to staff.
B. Staff can identify emergency evacuation routes.
C. Staff has completed training and understands their role in an emergency or natural
disaster.
D. Exits are recognizable and free from barriers.
13.3 Standards of Conduct
Sub-recipients must establish policies to prevent employees, consultants, or members of
governing/advisory bodies from using their positions for purposes that are, or give the
appearance of being, motivated by a desire for private financial gain for themselves or others
(HHS Grants Policy Statement 2007, II-7). (Section I, page 34)
13.4 Human Subjects Clearance (Research)
Research conducted within Title X projects may be subject to Department of Health and
Human Services regulations regarding the protection of human subjects (45 CFR Part 46). Sub-
recipients must advise the MDHHS in writing of research projects involving Title X clients or
resources in any segment of the project.
A. MDHHS must approve human subject research through submission to the MDHHS
Institutional Research Board (IRB) process.
B. MDHHS will advise the OPA Regional Office in writing of any approved research
project that involves Title X clients (HHS Grants Policy Statement 2007, II-9). (Section I,
page 34)
13.5 Financial and Reporting Requirements
Sub-recipients must comply with MDHHS minimum reporting requirements, including the
Office of Population Affairs (OPA) Family Planning Annual Report (FPAR) as described in
the OPA FPAR Forms and Instruction manual at intervals specified by MDHHS. In addition,
sub-recipients must have policies and procedures in place to follow Michigan mandatory
reporting requirements under the Michigan Child Protection Act and compliance with
Michigan’s Human Trafficking law and must file an annual health care plan, (Section I, pages
32, 45-47, 52-53 and 54-56).
A. MDHHS requires semi-annual FPAR reports: (1) a mid-year report covering the
reporting period January through June and (2) an annual report covering the reporting
period January through December.
1. Sub-recipients must have a system in place for collecting all required data elements
for the FPAR.
2. Sub-recipients must have a system in place for validating the data reported in the
FPAR.
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13.5 Financial and Reporting Requirements
B. MDHHS requires agencies file an annual needs assessment and health care plan (Annual
Plan) following MDHHS instructions.
C. MDHHS requires agencies to have policies and procedures in place for mandatory
reporting requirements under Michigan’s Child Protection Act and training on
Michigan’s Human Trafficking Law.
Sub-recipients must have program data reporting systems which accurately collect and
organize data for program reporting and which support management decision making and act in
accordance with other reporting requirements as required by HHS.
Sub-recipients must demonstrate continued institutional, managerial, and financial capacity
(including funds sufficient to pay the non-Federal share of the project cost) to ensure proper
planning, management, and completion of the project as described in the award (42 CFR
59.7(a)).
Sub-recipients must reconcile reports, ensuring that disbursements equal obligations and
drawdowns. HHS is not liable should the recipient expenditures exceed the actual amount
available for the grant.
14. ADDITIONAL CONDITIONS
With respect to any grant, HHS may impose additional conditions prior to or at the time of any
award, when, in the judgment of HHS, these conditions are necessary to assure or protect
advancement of the approved program, the interests of public health, or the proper use of grant
funds (42 CFR 59.12). MDHHS assures compliance with HHS grant conditions.
15. CLOSEOUT
Upon the end of grant support sub-recipients must submit the following in compliance with
their MDHHS contract:
A. A final Financial Status Report (FSR)
B. A final Family Planning Annual Report (FPAR) report
C. A final progress report regarding:
1. Accounting for any remaining inventory, contraceptive supplies and materials
purchased with Title X funds. Supplies may be distributed to other sub-recipients.
2. Notification and transfer, where appropriate, of Title X clients, including
arrangements for clients to obtain copies of their medical records and a list of
alternative family planning services providers where transfer of clients is not
available.
3. Identification of any equipment purchased with Title X funds with acquisition cost
more than $5,000 for appropriate transfer or retention.
Following closeout, the sub-recipient remains obligated to return funds due as a result of any
later refunds, corrections, or transactions, and MDHHS may recover amounts based on the
results of an audit covering any part of the period of grant support (HHS Grants Policy
Statement, II-90). (Section I, page 34)
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16. OTHER APPLICABLE HHS REGULATIONS AND STATUTES
The following HHS Department-wide regulations that apply to grants under Title X: (Section I,
pages 34, 35)
A. 37 CFR Part 401: Rights to inventions made by nonprofit organizations and small
business firms under government grants, contracts, and cooperative agreements
B. 42 CFR Part 50, Subpart D: Public Health Service grant appeals procedure
C. 45 CFR Part 16: Procedures of the Departmental Grant Appeals Board
D. 2 CFR Chapter I, Chapter II, Part 200: Uniform administrative requirements, Cost
Principles, and Audit Requirements for Federal Awards; Final Rule. Federal Register
December 26, 2013. This guidance streamlined requirements and supersedes HHS
regulations (45 CFR Parts 74 and 92) and administrative requirements (A-110 and A-
102), cost principles (A-21, A-87, and A-122), audit requirements (A-50, A-89, and
A-133).
E. 45 CFR Part 80: Nondiscrimination under programs receiving Federal assistance
through HHS effectuation of Title VI of the Civil Rights Act of 1964
F. 45 CFR Part 81: Practice and procedure for hearings under Part 80 of this Title
G. 45 CFR Part 84: Nondiscrimination on the basis of disability in programs and activities
receiving or benefitting from Federal financial assistance
H. 45 CFR Part 91: Nondiscrimination on the basis of age in HHS programs or activities
receiving Federal financial assistance
I. 45 CFR Part 100: Intergovernmental Review of Department of Health and Human Services
Programs and Activities
The following statutes are applicable to grants under Title X: (Section I, pages 36-40)
A. The Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191)
B. The Trafficking Victims Protection Act of 2000, as amended (Public Law 106-386)
C. Sex Trafficking of Children or by Force, Fraud, or Coercion (18 USC 1591)
D. The Patient Protection and Affordable Care Act (Public Law 111-148)
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SECTION III
Clinical Services
84
Clinical Services
17. INTRODUCTION
The MI Family Planning Clinical Standards and Guidelines were adapted from the document,
Providing Quality Family Planning Services (QFP), 2014 that provides recommendations
developed collaboratively by CDC and the Office of Population Affairs (OPA) of the U.S.
Department of Health and Human Services (HHS). The QFP document describes how to provide
quality family planning services to men and women. The goal of family planning services is to
assist individuals to achieve the desired number and spacing of children and to increase the
chances that children will be born healthy. Quality Title X Family Planning includes these
attributes: confidentiality, safety, effectiveness, client-centered approach, timeliness, efficiency,
accessibility, equity and cost effectiveness. Quality Family Planning Services include the
following clinical elements:
• Contraceptive services
• Pregnancy testing and counseling
• Achieving desired pregnancy (fertility awareness)
• Basic infertility service
• Preconception health services
• Sexually transmitted disease (STD) services
Title X providers must offer all family planning services (listed above), related preventive health
services (discussed on pages 103,104) and referral for specialist care, as needed. Other
preventive health services that are beyond the scope of Title X may be offered either on-site or
by referral. Information about preventive services that are beyond the scope of Title X is
available at http://www.uspreventiveservicestaskforce.org.
All family planning projects must offer family planning services and related preventive health
services to female and male clients, including adolescents. All projects must provide for medical
services related to family planning and the effective use of contraceptive devices and practices
including provider’s consultation, examination, prescription, and continuing supervision,
laboratory examination, contraceptive supplies, as well as necessary referrals to other medical
facilities when medically indicated (42 CFR 59.5(b)(1)). This includes, but is not limited to
emergencies that require referral. (See referrals pages 104,105) Efforts may be made to aid the
client in finding potential resources for reimbursement of the referral provider, but projects are
not responsible for the cost of this care.
18. SERVICE PLANS AND PROTOCOLS
The service plan is the component of a sub-recipient’s annual health care plan which is
developed by staff and the medical director which identifies the services to be provided to clients
under Title X.
A. All sub-recipient agencies must offer a broad range of effective and medically (FDA)
approved family planning methods and services either on-site or by referral [59.5(a)(1)]. All
sub-recipient agencies must have written clinical protocols approved by MDHHS and signed
85
by the agency’s medical director, which outline procedures for the provision of each service
offered. Sub-recipient agencies must have written protocols available at each clinical site.
The clinic staff must use approved protocols for the provision of all family planning
services.
B. Clinical protocols must be written in accordance with the QFP document, Michigan Title X
Family Planning Program Standards and Guidelines, State of Michigan laws and nationally
recognized standards for medical care. Clinical Protocols must be current (i.e., updated
within the past 12 months) and signed annually by the medical director. The Michigan Title
X Family Planning Standards and Guidelines Manual must be available at each clinical site.
19. PROCEDURAL OUTLINE
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. All the QFP services
identified in the introduction must be offered to all clients and documented in the medical
record.
A. Service delivery to all clients must include the following:
1. Assuring clients are treated courteously and with dignity and respect.
2. Professional recommendations for how to address the needs of diverse clients, such as
Lesbian, Gay, Bi-sexual, Transgender, Questioning (LGBTQ) persons or persons with
disabilities should be consulted and integrated into procedures, as appropriate. Providers
should avoid making assumptions about a client's gender identity, sexual orientation,
race, or ethnicity; all requests for services should be treated without regard to these
characteristics. Similarly, services for adolescents should be provided in a "youth-
friendly" manner.
3. Assurance of confidentiality and the provision of privacy
4. Opportunity to participate in planning their own medical treatment.
5. Encouraging clients to voice any questions or concerns they may have.
6. Materials and/or interpreter available for those with limited ability to read or understand
English and for those who may be blind or hearing impaired.
7. Explanation of all procedures, range of available services, and agency fees and financial
arrangements.
B. Individual client education must be offered.
C. Individual counseling (an interactive process to assist the client in making an informed
choice) must be offered and/or provided prior to client making an informed choice regarding
family planning services. Adolescent counseling must include the following:
1. Title X providers of family planning services must offer confidential services to
adolescents and observe relevant state laws related to mandatory reporting of child abuse
and neglect and human trafficking. (Section I pages 45-47) Adolescents must be
informed that services are confidential, except that in special cases (e.g. child abuse)
reporting is required.
2. Title X providers must encourage and promote communication between the adolescent
and his or her parent(s) or guardian(s) about sexual and reproductive health. Adolescents
who come to the service site alone must be encouraged to talk to their parents or
guardians.
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3. Title X providers must provide counseling on how to resist attempts to coerce
adolescents into engaging in sexual activities.
D. A language appropriate general consent must be signed by the client prior to providing
services.
E. A medical history must be obtained appropriate to the type of services provided.
F. A physical examination, including necessary clinical procedures, must be provided, as
indicated.
G. Laboratory testing must be provided, as indicated.
H. Medications and/or supplies must be provided, as indicated/requested.
1. Must provide written specific instructions on how to use medications, if dispensed.
2. Must include danger signs and when, where, and how to obtain emergency care, return
schedule and follow-up
I. Follow-up and Referral must be provided, as indicated.
1. Provision of referrals as needed
2. Planned mechanism of client follow-up
a. Suggested return visit date
b. Contact information for emergencies after hours
c. Discuss access to primary care services
J. Emergency arrangements must be available for after hours and weekend care and should be
posted, given to, and/or explained to clients.
K. Return visits should assess the on-going plan of care and needed family planning related
services.
20. CLIENT ENCOUNTERS
A. The client’s written general consent for services must be obtained prior to receiving any
clinical services. (Sections 1001 and 1007, PHS Act; 42 CFR 59.5 (a) (2))
a. The general consent for services must include that services are voluntary, provided
without coercion to accept services or any particular method of family planning,
without prerequisite to accept any other service, and that services are confidential.
B. Client encounters with women and men of reproductive age may require different services
(i.e., contraceptive services, pregnancy testing and counseling, achieving pregnancy, STD
services and related preventive health services). For all clients, the following questions will
determine what family planning services are most appropriate for a given visit and must be
asked and documented.
1. What is the client's reason for the visit?
2. Does the client have another source of primary
health
care?
3.
What
is the
client's reproductive
life plan?
a. Providers should assess the client’s reproductive life plan (RLP) by asking questions
that lead to discussion like: Do you plan to have children (or more children) in your
future? How many children would you like to have? How long would you like to wait
until you become pregnant? Or use the One Key Question
®
“Would you like to
become pregnant in the next year?” as a pregnancy intention screen and follow-up
discussion. See RLP guidance at: http://www.cdc.gov/preconception/rlptool.html. Or
One Key Question guidance at https://powertodecide.org/one-key-question or March
of Dimes https://www.marchofdimes.org/materials/one-key-question-overview.pdf.
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20. CLIENT ENCOUNTERS
C. Client encounters with women and men of reproductive age should also include a zika risk
assessment, including asking about past and future travel plans for the client and partner(s).
Family Planning and Related Preventive Health Services
for Women
Source:
Centers for Disease Control and Prevention (CDC). (2014, April 25). Providing quality family planning services: Recommendations CDC and the U.S. Office of Population
Affairs. MMWR. Morbidity and Mortality Weekly Reports. Retrieved from http://www.cdc.gov/mmwr/pdf/rr/rr6304.pdf
Abbreviations:
BMI = body mass index; HBV = hepatitis B virus; HIV/AIDS = human immunodeficiency virus/acquired immunodeficiency syndrome; HPV = human
papillomavirus; IUD = intrauterine device; STD = sexually transmitted disease.
1
This table presents highlights from CDC’s recommendations on contraceptive use. However, providers should consult appropriate guidelines when treating individual patients to obtain
more detailed information about specific medical conditions and characteristics (Source: CDC, U.S. medical eligibility criteria for contraceptive use 2010. MMWR 2010; 59[No. RR-4]).
2
STD services also promote preconception health but are listed separately here to highlight their importance in the context of all types of family planning visits. The services
listed in this column are for women without symptoms suggestive of an STD.
3
Weight (BMI) measurement is not needed to determine medical eligibility for any methods of contraception because all methods can be used (US Medical Eligibility Criteria 1) or
generally can be used (US Medical Eligibility Criteria 2) among obese women. (Source: CDC. U.S. medical eligibility criteria for contraceptive use 2010. MMWR 2010; 59[No. RR-4]).
However, measuring weight and calculating BMI at baseline might be helpful for monitoring any changes and counseling women who might be concerned about weight change
perceived to be associated with their con
traceptive method.
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4
Indicates that screening is suggested only for those persons at highest risk or for a specific subpopulation with high prevalence of an infection or condition.
5
Most women do not require additional STD screening at the time of IUD insertion if they have already been screened according to CDC’s STD Treatment Guidelines (Sources: CDC.
STD treatment guidelines. Atlanta, GA: US Department of Health and Human Services, CDC; 2013. Available at http://www.cdc.gov/std/treatment
. CDC. Sexually transmitted diseases
treatment guidelines, 2010. MMWR 2010; 59[No. RR-12]). If a woman has not been screened according to guidelines, screening can be performed at the time of IUD insertion and
insertion should notbe delayed. Women with purulent cervicitis or current chlamydial infection or gonorrhea should not undergo IUD insertion (U.S. Medical Eligibility Criteria 4). Women
who have a very high individual likelihood of STD exposure (e.g., those with a currently infected partner) generally should not undergo IUD insertion (U.S. Medical Eligibility Criteria 3)
(Source:
CDC. US medical eligibility criteria for contraceptive use 2010. MMWR 2010; 59[No. RR-4]). For these women, IUD insertion should be delayed until appropriate testing and
treatment occurs.
Note: These two charts provide a checklist of recommended family planning and related preventive health
services (QFP pages 22, 23).
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21.
CONTRACEPTIVE SERVICES
Written protocols and operating procedures must be current and in place for contraceptive
services. Sub-recipient
agencies
must
offer
contraceptive services
to
clients
who
wish to
delay
or
prevent pregnancy.
The delivery of preconception, STD, and related preventive
health services must not be a barrier to a client's ability to receive services related to preventing
or achieving pregnancy. Receiving services related to preventing or achieving pregnancy is the
priority; if other family planning services cannot be delivered at the initial visit, follow-up visits
should be scheduled.
A. Contraceptive services must include:
1. A
broad
range
of
FDA-approved
contraceptive methods. All
methods of
contraception must have written protocols in place.
a. Current CDC Medical Eligibility Criteria (MEC) must be followed when prescribing
contraceptives.
b. More than one method may be used simultaneously by the client (hormonal method
and condoms). Clients with high-risk sexual behavior patterns should be encouraged
to use condoms correctly and consistently in addition to any other chosen method to
reduce the risks of STIs/HIV and pregnancy.
B. Broad Range Contraceptives includes:
1. Hormonal Contraceptives
a. At least two delivery methods of combined hormonal contraceptives must be
available on site.
b. At least one delivery method of progestin-only contraceptives must be available on
site.
c. At least a second type of progestin-only method must be made available on site
within two weeks of client request.
2. Condoms
a. At least male condoms must be available on site.
3. At least one type of long acting reversible contraceptive (LARC) method must be
provided, either on site or by paid referral.
4. Education materials and information regarding all methods including, hormonal
contraceptives, abstinence, natural family planning, barrier methods, intrauterine devices,
sterilization, and emergency contraception.
5. The agency formulary must indicate:
a. Methods maintained and available on site
b. Methods available on site within two weeks of client request
c. Methods available by paid referral.
d. Methods available by unpaid referral (i.e., sterilization)
6. Agencies must maintain a formal referral agreement for any required broad range method
not provided on site.
7. A referral resource list should be provided for contraceptives not available in the clinic.
8. Agencies are encouraged to review current practice and the needs of their client
population and maintain the most frequently used methods where feasible.
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9. Agencies are strongly encouraged to provide emergency contraception and maintain
supplies on site.
10. Prescriptions may be written for contraceptives on the clinic formulary or on the client’s
insurance plan formulary. Accepting a prescription must not pose a barrier for the client.
C. Emergency Contraception
Emergency contraception has been found by the FDA to be safe and effective for use when
initiated after unprotected intercourse. The provision of emergency contraception is strongly
encouraged but not required for delegate agencies. Emergency Contraception education and
referral must be provided to all female clients when not provided on site. When delegate
agencies provide emergency contraception the following must occur:
1. Written protocol must be in place.
2. If indicated by the client’s history, a negative, highly sensitive pregnancy test is necessary
to exclude a pre-existing pregnancy.
3. Birth control counseling should accompany or follow any method used for emergency
contraception purpose in order to discourage women from using emergency contraception
as a routine method of contraception.
D. Permanent Contraception (Sterilization)
1. Education and information regarding sterilization must be provided for both male and
female clients, if indicated.
2. Sub-recipient agencies must have a list of community providers where clients can be
referred for sterilization. Paid referrals for sterilization are not required.
3. Sub-recipient agencies performing sterilization procedures must meet Federal regulations
for sterilization informed consent.
E. The clinic visit: A medical history must be taken prior to prescribing contraception to
ensure that methods of contraception are safe for the client.
1. For a female client, the medical history must include:
a. Reproductive life plan
b. Menstrual history
c. Gynecologic history
d. Obstetrical history
e. Contraceptive use
f. Allergies
g. Medications
h. Immunizations (use of the MI. Care Improvement Registry “MCIR” is strongly
recommended)
i. Recent intercourse
j. Reproductive history
k. Infectious or chronic health condition (present)
l. Zika risk assessment
m. Other characteristics and exposures (e.g., age, postpartum, breastfeeding) that might
affect the client's medical eligibility criteria (MEC) for contraceptive methods.
n. Social history/risk behaviors
o. Sexual history and risk assessment
p. Mental health
q. Intimate partner violence
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r. Interest in Sterilization, if age appropriate (> 21 per federal law requirement)
2. For a male client, the medical history must include:
a. Reproductive life plan
b. Use of condoms
c. Allergies (i.e., condoms)
d. Medications
e. Immunizations (use of the MI. Care Improvement Registry “MCIR” is strongly
recommended)
f. Recent intercourse
g. Partner history (use of contraception, pregnant, has children, had a miscarriage or
termination)
h. Infectious or chronic health condition (present)
i. Zika risk assessment
j. Contraceptive experiences and preferences
k. Sexual history and risk assessment
l. Interest in sterilization, if age appropriate (> 21 per federal law requirement)
NOTE: Taking of a medical history must not be a barrier to making condoms available in the
clinical setting (i.e., a formal visit must not be a prerequisite for a client to obtain condoms).
F. Physical and Laboratory Assessment
1. For a female client the following must be provided:
a. BP (when providing combined hormonal method and screening for hypertension)
1) All clients—screen yearly
2) If BP <120/80---screen yearly, continue yearly
3) If BP 120-139/80-89 (either treated or untreated), recheck BP again in same visit
if average BP >140/90 recheck at next visit or in 1 week and refer if sustained
BP >140/90.
b. Bimanual exam and cervical inspection (prior to IUD insertion, fitting diaphragm or
cervical cap)
c. Pap screening and clinical breast exam (based on current recommendations for timing
and testing components). See Related Preventive Health Services section.
d. Chlamydia testing must be offered annually for all females < 25 years, Sexually
active women >25 years with risk factors (infected partner, partner with other
concurrent partners, symptoms, history of STI or multiple partners in the last year)
(See page 101 in the STD section referencing the IPP pre-paid forms)
e. CT and GC testing must be available for clients requesting IUD insertion, if
indicated.
2. For a male client, laboratory tests are not required unless indicated by history.
3. Referral for Zika screening if indicated.
G. Client Education and Counseling
Contraceptive
counseling is
to help
a client choose
a
method
of
contraception
and
use it
correctly and consistently
. Clients (adolescents and adults) who are undecided on
a contraceptive method must be informed about all methods that can be used safely based on
the 2016 CDC Medical Eligibility Criteria. When educating clients about the broad range of
contraceptive methods, information must be medically accurate, balanced, and provided in a
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nonjudgmental manner. To assist clients in making informed decisions, providers should
educate clients in a manner that can be readily understood and retained. Documentation of
education/counseling must be in the client’s medical record.
1.
When educating
clients about
contraceptive methods that
can be used safely,
clients
must
understand
the
f
o
ll
o
win
g
:
a. Method effectiveness
b.
Correct and consistent
use of the
method
c. Benefits and Risks
d. Potential Side effects
e. Protection from STDs, including HIV
f. Starting the method
g. Danger signs
h. Availability of emergency contraception (provide on-site or by prescription)
i. Follow-up visit (to obtain selected method)
2. Quality contraceptive counseling includes the following:
a. Establish and maintain rapport
b. Assess the client’s need and personalize the discussion
c. Work with the client to establish a plan
d. Provide information in a manner that can be understood by the client
e. Confirm the client’s understanding
i. The teach-back method may be used to confirm the client's understanding by
asking the client to repeat back messages about effectiveness, risks, benefits,
method use, protection from STDs and follow-up. (QFP pages 45-46)
3. Documentation of counseling must be included in the client record (i.e., checkbox or
written statement).
4. Client information sheets should be used for education.
5. When counseling male clients, discussion should include information about female-
controlled methods where appropriate (including emergency contraception), encourage
discussion of contraception with partners, and provide information about how partners
can access contraceptive services. Male clients should also be reminded that condoms
should be used correctly and consistently to reduce risk of STDs, including HIV.
6. When counseling any client, encourage partner communication about contraception, as
well as understanding partner barriers (e.g. misperceptions about side effects) and
facilitators (e.g., general support) of contraceptive use.
7. A procedure consent form must be signed by the client prior to inserting an IUD or
implant.
8. Clinical evaluation of a client electing permanent sterilization should be guided by the
provider who performs the procedure.
9. Provide Zika education and prevention strategies.
H. Counseling Adolescent Clients
Comprehensive information must be provided to adolescent clients about how to prevent
pregnancy. Adolescent services should be provided in a "youth- friendly" manner, which
means that they are accessible, equitable, acceptable, appropriate, comprehensive, effective,
and efficient for youth. Information should clarify that:
93
1. Avoiding sex (i.e., abstinence) is an effective way to prevent pregnancy and STDs. If the
adolescent indicates that she or he will be sexually active, provide information about
contraception and help her or him to choose a method that best meets her or his
individual needs, including the use of condoms to reduce the risk of STDs/HIV. Long-
acting reversible contraception is a safe and effective option for many adolescents,
including those who have not been pregnant or given birth.
2. Title X providers of family planning services must offer confidential services to
adolescents and observe relevant state laws related to mandatory reporting of child abuse
and neglect and human trafficking (Section I.B of this manual). Adolescents must be
informed that services are confidential, except that in special cases (e.g. child abuse)
reporting is required.
3. Title X providers must encourage and promote communication between the adolescent
and his or her parent(s) or guardian(s) about sexual and reproductive health. Adolescents
who come to the service site alone must be encouraged to talk to their parents or
guardians.
4. Title X providers must provide counseling on how to resist attempts to coerce
adolescents into engaging in sexual activities.
I. Counseling Returning Clients
When providing contraceptives for returning clients, an assessment should include the
following:
1. Method concerns
2. Method use (consistent, correct)
3. Any changes in client’s history (i.e., risk factors, medications)
If appropriate, provide additional contraceptives and discuss a follow-up plan.
J. Preventive Health Promotion and Referral
1. Title X providers should refer pregnant, parenting and postpartum adolescents to home
visiting and other programs (MIHP, Nurse Partnership) that have been demonstrated to
provide needed support and reduce rates of repeat teen pregnancy.
2. Title X providers should provide a referral resource list for mental health and risky social,
ETOH, tobacco, substance use.
3. Title X providers should provide a referral resource list for immunizations as indicated.
22. PRECONCEPTION HEALTH SERVICES
Preconception describes anytime that a woman of reproductive potential is not pregnant but at
risk of becoming pregnant, or when a man is at risk for impregnating his female partner. A
written protocol and procedure must be current, available and consistent with national standards
of care. Agencies must offer preconception health services to females and males as part of core
family planning services. Preconception health services promote health before conception
thereby reducing pregnancy-related adverse outcomes (low birth weight, premature birth, and
infant mortality), promote birth outcomes and improve the health of male and female clients
even if they choose not to have children.
The clinic visit includes:
A. Medical history for females must include:
94
1. Reproductive life plan
2. Sexual risk assessment
3. Reproductive history
4. History of prior pregnancy outcomes
5. Environmental exposures
6. Medications
7. Genetic conditions
8. Family history
9. Intimate partner violence
10. Social history/risk behaviors
11. Immunizations (MCIR is strongly recommended)
12. Depression
13. Zika risk assessment
B. Medical history of males must include:
1. Reproductive life plan
2. Sexual health assessment
3. Past medical and surgical history that impairs reproductive health
4. Genetic conditions
5. History of reproductive failures, or conditions that can reduce sperm quality (obesity,
diabetes, varicocele
6. Social history/risk behaviors
7. Environmental exposures
8. Immunizations status (MCIR is strongly recommended)
9. Depression
10. Zika risk assessment
C. Physical Examination for all clients:
1. Height, weight, BMI (screen for obesity)
2. BP (screen for hypertension- based on American Heart Assn. recommendations)
a. All clients—screen yearly
b. If BP <120/80---screen yearly, continue yearly
c.
If BP 120-139/80-89 (either treated or untreated), recheck BP again in same visit
and if average BP >140/90 recheck at next visit or in 1 week and refer if sustained
BP >140/90.
D. Laboratory testing must be recommended based on risk assessment:
1. Diabetes screening (for type 2 diabetes in asymptomatic males and females adults) with
sustained BP (either treated or untreated) >139/80 (USPSTF)
2. Referral for Zika screening if indicated.
E. Client Plan/Education
1. Some medications might be contraindicated in pregnancy, and any current medications
taken during pregnancy need to be reviewed by a prenatal care provider (e.g., an
obstetrician or midwife).
2. Encourage to take a daily supplement containing (400-800 mcg) of folic acid (or a
prenatal vitamin).
3. Avoid smoking, alcohol and other drugs
95
4. Avoid eating fish that might have high levels of mercury (e.g., King Mackerel, Shark,
Sword fish, Tile fish)
5. Offer/Refer for any needed STD screening (including HIV)
6. Refer for age appropriate vaccinations, if indicated
7. Provide Zika education and prevention strategies
F. Referral:
1.
If client desires, refer for further diagnosis and treatment
2. Refer male and female clients for additional services if screening results indicate
presence of health condition or as indicated (i.e., tobacco cessation, obesity, diabetes,
depression, immunizations).
23. ACHIEVING PREGNANCY SERVICES
A written protocol and procedure must be current, available, and consistent with national
Standards of care. Agencies must offer services on achieving pregnancy to females and males
who want to become pregnant as part of their core family planning services. The goal is to
address the needs of clients who wish to become pregnant in accordance with current standards
of practice.
Achieving Pregnancy services will be offered to clients who respond to the reproductive life plan
questions stating they desire to become pregnant. Achieving pregnancy services include:
Identifying and assessing clients who desire pregnancy; providing counseling and education
(including key messages on achieving pregnancy) and addressing misperceptions that many
women, men and adolescents have about fertility and infertility. Clients who have been trying to
achieve pregnancy for 12 months or longer with regular unprotected intercourse should be
offered basic infertility services.
A. Client assessment includes:
1. Reproductive Life Plan
2. When she or they want to get pregnant
3. Length of time she or they have been trying to become pregnant.
a. If less than 1 year, provide counseling on maximizing fertility success
4. History of pregnancies or infertility
5. Partner involvement and support system issues
a. Support system issues may include: family and community support, LGBTQ
considerations, single parent considerations, cultural/familial considerations, and
awareness of other concerns or influences.
6. Zika risk assessment, including past travel for both client and partner in the past 8
months, as well as future travel plans for both client and partner
B. Medical history includes:
1. Immunizations
2. Medications
3. Present infectious or chronic health conditions
4. Genetic conditions
5. Environmental exposures
96
6. Social history/risk behaviors
7. Sexual health assessment and risk assessment
8. Mental health
9. Medical history for females must Include:
a. Reproductive history
b. Obstetrical/Gynecology history
c. Family history
d. Intimate partner violence
10. Medical history for males must include:
a. Past medical or surgical history that might impair reproductive health
b. Medical conditions associated with reproductive failure that could reduce sperm
quality
C. Assessing and updating the client’s physical, sexual and medical history may reveal additional
issues in the person’s health history that need to be addressed. The results can also help
determine the need for additional information like fertility awareness or other health services
such as: STD screening, preconception care, infertility services, possible need for Zika
screening, and other preventative health services.
D. Client education and counseling includes
:
1. Importance of regular preventive health and chronic disease management
2. Some medications might be contraindicated in pregnancy and current medications will
need to be reviewed by the prenatal care provider (obstetrician, physician, or midwife)
3. Encourage daily supplement containing (400-800 mcg) of folic acid or a prenatal
vitamin
4. Avoid smoking, alcohol and other drugs.
5. Avoid eating fish that might have high levels of mercury (e.g., King Mackerel, Shark,
Sword fish, Tile fish)
6. Offer/refer for any needed STD screening, including HIV
7. Offer/refer for age appropriate vaccinations, as indicated
8. Nutritional counseling and recommended weight loss if client is overweight
9. Provide Zika education and prevention strategies
10. Counseling provided must be documented in the record
E. Education on maximizing fertility awareness and success includes:
1. Fertility awareness/ Techniques to predict ovulation
a. Education about peak days and signs of fertility (including the 6-day interval ending
on the day of ovulation that is characterized by slippery, stretchy cervical mucus and
other possible signs of ovulation)
b. Education on methods or devices designed to determine or predict the time of
ovulation (e.g., over-the-counter ovulation kits, digital telephone applications, or
cycle beads) should be discussed
2. Lifestyle influences
a. Advise that vaginal intercourse every 1-2 days beginning soon after the menstrual
period ends can increase the likelihood of becoming pregnant (women with regular
menstrual cycles)
97
b. Information that fertility rates are lower among women who are very thin or obese,
and those who consume high levels of caffeine (e.g., more than five cups a day)
c. Discourage smoking, alcohol, recreational drugs, and use of commercially available
vaginal lubricants that may reduce fertility
d. Education on Zika risks and the importance of Zika prevention for couples seeking
pregnancy
e. Encourage a daily supplement containing folic acid or prenatal vitamin
f. Encourage males to avoid hot tubs
F. Referral
If desired, clients should be provided a current referral listing for further diagnosis and
treatment.
24. PREGNANCY DIAGNOSIS AND COUNSELING
Agencies must provide pregnancy diagnosis and counseling to all clients in need of this service
(42 CFR 59.5(a) (5)).
Pregnancy testing is one of the most common reasons for a first visit to a
family planning agency. It is therefore important to use this occasion as an entry point for
providing education and counseling about family planning services. A written protocol and
procedure must be current, available and consistent with national standards of care.
A. Pregnancy diagnosis services include:
1. General Consent for Services
2. Reproductive Life Plan Discussion
3. Medical history (including chronic medical illnesses, physical disability, psychiatric
illness)
4. Zika risk assessment
5. Pregnancy testing (qualitative urine with high sensitivity)
6. Pregnancy test results must be given to the client
7. Counseling and referral resource list as appropriate
8. Chlamydia testing must be offered to females <25 years of age and to females >25 years
with risk factors.
B. If the pregnancy test is positive, the clinical visit should
include:
1. An estimation of gestational age so that appropriate counseling can be provided.
If a woman is uncertain about the date of her last normal menstrual period, a pelvic
examination might be needed to help assess gestational age.
2. Information about the normal signs and symptoms of early pregnancy
3. Instructions on when to report any concerns to a provider for further evaluation.
4. If ectopic pregnancy or other pregnancy abnormalities or problems are suspected, the
client must be referred for immediate diagnosis and management.
C. If the pregnancy test is positive, all of the following counseling options to manage the
pregnancy must be offered, except with respect to any option(s) about which the pregnant
woman indicates she does not wish to receive such information and counseling.
1. Prenatal care and delivery
2. Infant care, foster care, or adoption
3. Pregnancy termination
98
D. Pregnancy options counseling must be provided in a non-directive, unbiased manner. When
requested to provide such information and counseling, agencies must provide neutral, factual
information and nondirective counseling on each of the options. and referrals upon request,
except with respect to any options about which the pregnant woman indicates she does not
wish to receive information and counseling. [59.5(a) (5)].
E. Referral to appropriate providers of follow-up care must be made at the request of the client,
as needed. For example, providers must provide a resource listing or directory of providers
to help the client identify options for care.
F. Providers also should assess the client's social support and refer her to appropriate counseling
or other supportive services, as needed.
G. For clients who are considering or choose to continue the pregnancy, a prenatal care referral
must be provided, and initial prenatal counseling must be provided that includes:
1. Pregnant women with risk factors should be tested for STDs (including HIV) at the time
of their positive pregnancy test if there will be delays in obtaining prenatal care (more
than 2 months).
2. Advise that some medications might be contraindicated in pregnancy, and any current
medications taken during pregnancy need to be reviewed by a prenatal care provider
(e.g., an obstetrician or midwife).
3. Encourage to take a daily supplement containing (400-800 mcg) of folic acid (or a
prenatal vitamin).
4. Avoid smoking, alcohol, and other drugs.
5. Avoid eating fish that might have high levels of mercury (e.g., King Mackeral, Shark,
Sword fish, Tile fish).
6. Refer for age appropriate vaccinations if indicated.
7. Referral for Zika screening if indicated.
H. Clients with a negative pregnancy diagnosis and do not want to become pregnant must be
offered information about family planning services as indicated, such as:
1. The value of making a reproductive life plan
2. Contraceptive services (or scheduled for an appointment)
3. Counseling to explore why the client thought she was pregnant and sought pregnancy
testing services
4. Assessed for difficulties using her current method of contraception, if indicated.
I. Women who are not pregnant and who are trying to
become
pregnant must be offered
information about family planning, as indicated, such as:
1. Services to help achieve pregnancy
or
basic infertility
services
2. Preconception health education
3.
STD
services
4. Reproductive life plan
5. Zika education and prevention strategies
25.
BASIC INFERTILITY SERVICES
A written protocol and procedure must be current, available and consistent with national
standards of care. Agencies must offer basic infertility care as part of core family planning
services. Infertility is defined as the failure of a couple to achieve pregnancy after 12 months or
longer of regular unprotected intercourse.
99
A.
Infertility
visit to a family
planning clinic
focuses on
determining potential
causes of the
inability to
achieve pregnancy and
making
any needed referrals for specialist care.
Evaluation
of
both
partners should
begin at the same time. Earlier
evaluation
(6 months
of regular unprotected intercourse) is justified for:
1.
Women
aged > 35 years
2. Those with a
history
of
oligom
enorrhea (infrequent menstruation)
3. Those with known or
suspected uterine
or tubal disease or
endometriosis
4.
Those
with a
partner
known to be
sub-fertile
(the
condition
of
being
less
than
normally
fertile
though
still
capable
of
effecting
fertilization).
B.
An early evaluation may be
warranted
if risk factors of male infertility
are
known
to
be present
or
if there are
questions regarding
the male
partner's fertility
potential.
C.
Basic Infertility Care for Women. The infertility visit
should
focus on:
a.
Understanding
the
client's
reproductive
life plan and
difficulty
in
achieving
pregnancy.
b.
The medical
history
must
include:
a.
Past surgeries
b.
Previous
hospitalizations
c.
Serious illnesses or
injuries
d.
Medical
conditions
associated with
reproductive
failure (e.g.,
thyroid
disorders,
hirsutism,
or
other endocrine disorders)
e.
Childhood disorders
f.
Cervical cancer
screening results and
any
follow-up
treatment
g.
Medication
h.
Allergies
i.
Social history/risk behaviors
j.
Family history of reproductive failures
k.
Reproductive history
(i.e., time trying to achieve
pregnancy;
coital
frequency
and
timing)
l.
Level
of fertility
awareness
m. Previous evaluation and treatment results; gravidity, parity, pregnancy outcome(s), and
associated complications; age at menarche, cycle length and characteristics, and
onset/severity of dysmenorrhea
n. Sexual history (pelvic inflammatory disease, history of/exposure to STDs)
o. Review of systems (symptoms of thyroid disease, pelvic or abdominal pain,
dyspareunia, galactorrhea, and hirsutism)
p. Zika risk assessment
3. A physical
examination
must be offered if clinically indicated:
a. Height, weight,
and
body mass index (BMI)
calculation
b.
Thyroid
examination (i.e.,
enlargement,
nodule, or
tenderness)
c. Clinical
breast
examination (CBE)
d. Signs of
androgen
excess
e. A pelvic
examination
(i.e., pelvic or
abdominal tenderness,
organ
enlargement/
mass; vaginal or
cervical
abnormality, secretions, discharge; uterine
100
size
,
shape,
position,
and mobility; adnexal mass or tenderness; and cul-de-sac
mass,
tenderness, or
nodularity).
D.
Basic Infertility Care for Men. Infertility services provided to the male partner of an infertile
couple should include:
1. Client's reproductive life plan
2. Medical history must include:
a. Reproductive history (methods of contraception, coital frequency and timing;
duration of infertility, prior fertility; sexual history; and gonadal toxin exposure,
including heat).
b. Medical illnesses (e.g., diabetes mellitus)
c. Prior surgeries
d. Past infections
e. Medications (prescription and nonprescription)
f. Allergies
g. Lifestyle exposures
h. Sexual health assessment.
i. Female partners' history (pelvic inflammatory disease, STDs, and problems with
sexual dysfunction)
j. Zika risk assessment
3. A physical examination must be offered if clinically indicated:
a. Examination
of the penis (
including
the location of the urethral meatus)
b.
Palpation of the testes and
measurement
of their size
c. Presence and consistency
of
both the vas deferens and epididymis
d. Presence of a varicocele
e. Secondary sex
characteristics
4. Male clients concerned about their fertility should be offered a semen analysis via an
unpaid laboratory requisition. If this test is abnormal, they should be referred for further
diagnosis (i.e., second semen analysis, endocrine evaluation, post-ejaculate urinalysis, or
others deemed necessary) and treatment. The semen analysis is the first and most simple
screen for male fertility.
E.
Infertility Counseling
Counseling provided during the clinic visit is guided by information elicited from the client
during the medical and reproductive history and findings from the physical exam. Provide
Zika education and prevention strategies.
F. Referral:
1. Clients (female and male) must be
referred
for
further
diagnosis and
treatment if
indicated or requested.
2. Referral for Zika screening if indicated
26. SEXUALLY TRANSMITTED DISEASE SERVICES
Written protocols and operating procedures for sexually transmitted infections must be in place
when STD/HIV services are provided. Screening and treatment must follow current Centers for
Disease Control (CDC) STD Treatment and HIV testing guidelines.
A. Assess client’s Reproductive Life Plan
101
B. Medical history
1. Allergies
2. Medications
3. Medical conditions
4. Sexual health assessment, based on gender identify, current anatomy and sexual behavior
(partners, practices, protection, past history of STDs, pregnancy prevention)
5. Immunizations (Hep.B, HPV)
6. Zika risk assessment
C. Physical Exam as indicated (based on history or symptoms)
D. Laboratory testing including the following:
1. Chlamydia:
a. Testing must be offered annually for all females < 25 years. Sexually active women
>25 years with risk factors (infected partner, partner with other concurrent partners,
symptoms, history of STD or multiple partners in the last year) should be offered
testing.
b. Clients who test positive for Chlamydia should be re-tested 3 months following
treatment for early detection of re-infection. Clients who do not present at 3 months
for re-test should be re-tested the next time they present for services in the 12 months
following treatment of the initial infection.
c. Chlamydia screening for males can be considered at sites with high prevalence
(adolescent clinics, correctional facilities, STD clinics) or males who have sex with
males (MSM). Males with Chlamydia should be re-tested 3 months following
treatment.
d. The MDHHS family planning program supports the MDHHS Infertility Prevention
Project (IPP) by allocating pre-paid test forms for CT/GC to each sub-recipient
agency based on population prevalence. These forms are intended for clients who are
uninsured, underinsured or request confidential testing services. Use of these pre-paid
forms should be based on the following criteria:
1) Priority goes to females under 25
2) Females 29 and under are eligible for testing with a pre-paid form
3) Based on historic positivity, males presenting in our family planning sites are
eligible for testing with a pre-paid form.
2. Gonorrhea
a. Testing must be offered annually to sexually active women <25 with high risks
(previous gonorrhea, presence of other STDs, new or multiple sex partners,
inconsistent condom use, commercial sex work, drug use) and those who reside in
high prevalence areas. Other risk factors that place women at increased risk include
infected partner, symptoms, history of STD or multiple partners in past year.
b. All males with symptoms suggestive of gonorrhea (urethral discharge or dysuria or
whose partner has gonorrhea) should be tested and empirically treated.
c. Males who have sex with males (MSM) should be tested at sites of exposure.
Clients with gonorrhea infection should be re-tested for re-infection 3 months after
treatment. Clients who do not present at 3 months for re-test should be re-tested the
next time they present for services in the 12 months following treatment of the initial
infection.
d. Pre-paid IPP forms may be used for testing based on guidance provided above in 1.d.
102
26. SEXUALLY TRANSMITTED DISEASE SERVICES
3. Syphilis
a. Testing should be offered to male and female clients at high risk:
1) MSM,
2) Commercial sex workers,
3) Persons who exchange sex for drugs,
4) Those in adult correctional facilities,
5) Living in high prevalence areas).
4. HIV/AIDS
a. Testing should be routinely recommended for all male and female clients 13-64 years
of age.
b. Annual testing is recommended for high risk individuals:
1) injection drug users and their partners
2) persons who exchange sex for money or drugs
3) sex partners of HIV infected persons
4) MSM or heterosexual persons who themselves or whose sex partner have had
more than one sex partner since their most recent HIV test
c. Opt out screening can be provided if included in the general medical consent.
5. Hepatitis C
a. Testing should be recommended once for female and male clients without risks (if
born during 1945-1965). If testing is positive, refer for additional care and
management of HCV infection and related conditions. Assess for alcohol use and
refer for intervention if indicated.
b. Clients with high risk behaviors /conditions (e.g., past or current injection of illegal
drugs, HIV infected) should be recommended to have annual testing.
6. Hepatitis B
1. Screening is not recommended for the general population.
2. Testing should be recommended for high risk populations (persons from high
prevalence areas, HIV positive, IV drug users, MSM, Hep.B household contacts.)
7. Zika Virus
1. Risk assessment questions should be asked of all clients. Has the client or partner(s)
traveled to a Zika impacted area in the past 8 months?
2. Consider referral for testing if sexually active and seeking pregnancy as appropriate.
3. All clients should be educated regarding Zika risks and prevention strategies.
G. STD treatment should be provided on-site. When treatment for any STD is provided on-site,
the sub-recipient must follow current Centers for Disease Control and Prevention STD
Treatment Guidelines ensure all clients are treated in a timely manner and appropriate
follow-up measures are provided.
F. Expedited Partner Therapy (EPT) should be offered as indicated for clients testing positive
for chlamydia and gonorrhea.
1. Michigan’s Public Act 525 of 2014 (MCL 333.5110) authorized the use of expedited partner
therapy (EPT) for certain sexually transmitted diseases as designated by the state department
of health. The department designated chlamydia and gonorrhea as diseases for which the use
of EPT is appropriate. Guidance for providers and information for clients are available at
www.michigan.gov/hivstd
or in section I of this manual (pages 47, 48)
103
G. Counseling
1. Educate on risk reduction and available testing or referral for testing.
2. Encourage vaccination for HPV and Hepatitis B if indicated
3. Encourage condom use to prevent STD/HIV infection
4. Encourage clients with STDs to:
a. Notify their sex partners and urge them to seek medical evaluation and treatment
b. Refrain from unprotected sexual intercourse during the period of STD treatment
c. Return for re-testing in 3 months if indicated
5. Educate on Zika risks and prevention strategies
H. Referral
1. Clients with Hepatitis C and HIV infection should be linked to medical care and
treatment.
2. Clients should be referred for needed immunizations.
I. Mandatory Reporting
3. Sub-recipient agencies must comply with state and local STD reporting requirements.
25. GYNECOLOGIC SERVICES
Family planning agencies should provide for the diagnosis and treatment of minor gynecologic
problems to avoid fragmentation or lack of health care for clients with these conditions. Written
protocols and operating procedures must be available, current and consistent with national
standards of care. Problems such as vaginitis or urinary tract infection may be amenable to on-
the-spot diagnosis and treatment, following microscopic examination of vaginal secretions or
urine dip stick testing.
26. RELATED PREVENTIVE HEALTH SERVICES
Written protocols and operating procedures must be available, current and consistent with
national standards of care. All sub-recipient agencies must comply with the current MDHHS
Family Planning Breast and Cervical Cancer Screening Protocol and must participate in the
Family Planning/Breast and Cervical Cancer Control Program (FP/BCCCP) Joint Project for
diagnostic services (i.e., breast ultrasound, mammogram and colposcopy) for uninsured or
underinsured clients. Coordination of care must go through the BCCCP Coordinator unless other
referral/payment arrangements are in place.
A. Clinics must offer and/or provide and stress the importance of the following to all clients:
1. Clinical Breast Exam (CBE) performed at least every three years for average-risk
asymptomatic women beginning at age 21 through age 39, and annually for women
>40 years.
2. Pap testing as indicated:
a. Age 21 to 65, every 3 years if Pap test is negative, OR
b. Age 30 to 65, every 5 years if using co-testing (pap and HPV) and both are
negative
3. Pelvic examination (including vulvar evaluation and bimanual exam) should be
performed with routine pap testing and must be provided if medically indicated.
B. Clinics must stress the importance of:
104
1. Screening mammography for women aged 50-74 years on a biennial basis.
2. Screening for women age 40-50, should be based on patient preference,
personal/family history, or other conditions that support screening.
C. Clinics should conduct a genital examination for adolescent males and document:
1. Skin and hair distribution (observation)
2. Hydrocele, varicocele, (observation and palpation)
3. Signs of STD (observation and/or palpation)
27. QUALITY MANAGEMENT
A. Referrals and Follow-up
Written protocols and operating procedures for referrals and follow-up must be in place for
the following: referrals that are made as result of abnormal physical exam or laboratory
findings, referrals for required services, and referrals for services determined to be necessary
but beyond the scope of family planning.
1. Referral procedures must be sensitive to clients’ concerns for confidentiality and privacy.
2. Client consent for release of information to providers must be obtained, except as may be
necessary to provide care or as required by law
3. Protocols and operating procedures for referrals and follow-up made as a result of
abnormal physical examination or laboratory test findings within the scope of Title X that
impact contraceptive management must include the following:
a. A system to document referrals and follow up procedures must be in place.
b. Follow-up procedures must include the following:
1) A method to identify clients needing follow-up
2) A method to track follow-up results on necessary referrals (such as, Pap and
breast follow-up)
3) Documentation in the client record of contact and follow-up.
4) Documentation of reasons, actions and follow-up where recommendations were
not followed and/or protocols not acted upon.
c. Referral procedures should include that the client be given an explanation of the
referral and need for follow-up including:
1) Reason and importance of the referral
2) Services to be received from the referral agency
3) Address of the referral provider/agency
4) Any instructions needed to follow through with the referral
5) When to return to the family planning clinic
4. Sub-recipient agencies must provide all Quality Family Planning Service components
either on-site or by referral. When required services are provided by referral, the agency
must have in place formal arrangements with a referral provider that includes a
description of the services provided and includes cost reimbursement information.
5. For services determined to be necessary but which are beyond the scope of the project
(such as thyroid abnormalities), clients must be referred to other providers for care.
When a client is referred for non-family planning or emergency clinical care, agencies
must:
a. Document that the client was advised of the referral and the importance of follow-up
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b. Document that the client was advised of their responsibility to comply with the
referral
6. Sub-recipients must maintain a current referral list that includes health care providers,
local health and human service departments, hospitals, voluntary agencies, and health
service projects supported by other federal programs.
a. Referral lists must be current and updated annually
b. When possible, clients should be given a choice of providers
B. Pharmaceuticals
Agencies must operate in accordance with Federal and state laws relating to security and
record keeping for drugs and devices. The inventory, supply, and provision of
pharmaceuticals must be conducted in accordance with state pharmacy laws and
professional practice regulations.
It is essential that each facility maintain an adequate supply and variety of drugs and devices
to effectively manage the contraceptive needs of its clients. Projects should also ensure
access to other drugs or devices that are necessary for the provision of other medical
services included within the scope of the Title X project. Agencies are allowed to write
prescriptions for Title X clients who choose and can conveniently obtain their
contraceptives and medications from a pharmacy. Prescriptions may be written for
contraceptives/medications on the clinic formulary or on the client’s insurance plan
formulary.
1. According to PH Code Act 368 of 1978
(http://www.legislature.mi.gov/(S(wjwslol3kv501nx23qrash4c))/mileg.aspx?page=getOb
ject&objectName=mcl-333-17745 ) as amended under Pharmacy Practice and Drug
Control 333.17745, a dispensing prescriber, except as authorized for expedited partner
therapy (EPT) in section 5110 or section 17744a/17744b, shall only dispense drugs to
his/her clients. Written protocols and operating procedures for the distribution, security
and record keeping of pharmaceuticals and supplies must meet the following required
standards:
a. The medical director of the family planning program is responsible for all policies
and procedures pertaining to the general handling of pharmaceuticals.
2. Prescription of pharmaceuticals is done under the direction of a physician (who must
have a drug control license for each location in which the storage and the dispensing of
prescription drugs occur). The physician may dispense indirectly under his/her delegated
authority to a R.N. or certified mid-level clinician. Pre-labeled, pre-packaged oral
contraceptives may be distributed if delegated by a dispensing prescriber.
a. All medications dispensed in Title X clinics must be pre-packaged.
b. Prescription medications dispensed (including samples) must be labeled and labels
must contain the following information:
1) Name and address of location from which the prescription drug is dispensed
2) Name of the client, unless prescription is authorized for EPT
3) Date the prescription drug is dispensed
4) Name, strength, and quantity of drug dispensed
5) Directions for use, including frequency of use
6) Prescriber’s name (medical director and prescribing practitioner)
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7) Expiration date of prescription drug
8) Record number of client
c. All clients must receive verbal and written instructions for each drug. Medication
education sheets should be kept current annually reviewed and revised as needed.
The nature of drug education should be documented in the medical records.
d. There must be documentation that in-service training pertaining to the nature and
safety aspects of pharmaceuticals is provided at least every two years to staff
involved in the provision of medications to clients (i.e., new staff orientation, staff
meeting, and quiz).
3. The inventory, supply and provision of pharmaceuticals may be delegated to
appropriately qualified health professionals.
a. Family planning health professionals delegated to deliver prescriptions drugs must be
trained in all aspects of pharmaceutical and supply distribution
b. Delegate agencies must have proper segregation between requisition, procuring,
receiving and payment functions for pharmaceuticals and supplies.
c. Delegate agencies must have an inventory system to control purchase, use, reordering
of pharmaceuticals and supplies.
d. Delegate agencies must have adequate controls over access to medications and
supplies including:
1) Contraceptive and therapeutic pharmaceuticals must be kept in a secure place,
either under direct observation or locked.
2) Access to pharmaceuticals must be limited to health care professionals
responsible for distributing these items.
3) Safeguards must be in place for assuring that supplies purchased through the
340 B program are provided only to clients of the family planning program.
e. A system must be in place to monitor the expiration date on drugs and ensure
disposal of all expired drugs.
f. A system for silent notification in case of drug recall must be in place.
g. Inventory levels should not exceed a six month supply.
4. A current formulary, listing all drugs available for Title X clients, must be maintained and
re viewed at least annually. Formularies should be retained for three years.
5. An adequate supply and variety of drugs and devices must be available to meet their
client's contraceptive needs.
a. Purchase and use of generic drugs based on therapeutic equivalence as published by
the FDA or in the Formularies of Therapeutic Equivalence accepted by the State
Board of Pharmacy is acceptable.
b. Sub recipient agencies may elect to identify certain supplies on the formulary, such as
more expensive or infrequently used methods, that will be ordered upon client request
and be available within two weeks of the request.
6. At a minimum, each site that provides medical services must have the following:
a. Emergency drugs and supplies for treatment of vaso-vagal reaction.
b. Emergency drugs and supplies for treatment of anaphylactic shock.
7. Prescriptive Methods for Transfer Clients
a. An informed (general) consent form must be obtained and a client history must be
completed/reviewed. A BP must be taken if the client desires to continue on a
combined hormonal contraceptive. The provider will review the transfer records and
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decide if current prescription can be continued. The provider must document the
prescription in the client's record.
C. Medical Emergencies
Emergency situations involving clients and/or staff may occur any time; therefore, all
agencies must have written plans and protocols/ operating procedures for the management of
on-site medical and non-medical emergencies.
1. At a minimum, written protocols must address:
a. Vaso-vagal reactions/Syncope (fainting)
b. Anaphylaxis
c. Cardiac arrest
d. Shock
e. Hemorrhage
f. Respiratory difficulties
2. Protocols must also be in place for emergencies requiring EMS transport, after hour’s
management of contraceptive emergencies and clinic emergencies.
3. All staff must be trained in emergency procedures and must be familiar with the plans.
Licensed medical staff providing direct patient care services must be trained in CPR and
hold current certification.
4. There must be a procedure in place for maintenance of emergency resuscitative drugs,
supplies, and equipment.
D. Medical Records
1. General Policy
a. A medical record must be established for each client who receives clinical services,
including pregnancy testing/counseling clients and emergency contraception clients.
b. Medical records are maintained in accordance with the accepted medical standards
and state laws with regard to record retention. Records must be:
1) Complete, legible, and accurate
2) Signed and dated by the clinician health professional making each entry
a) Each entry includes date, name and title of the clinician/health professional
b) Each entry is a permanent part of the record
3) Readily accessible
4) Confidential
5) Safeguarded against loss or use by unauthorized persons
6) Available upon request to the client
c. HIPPA regulations regarding personal health information must be followed.
d. Guidance regarding records management is available from the Michigan Department
of Technology, Management and Budget, Records Management Services.
http://www.michigan.gov/recordsmanagement
2. Record Contents
The client’s medical record must contain sufficient information to identify the client,
indicate where and how the client can be contacted, justify the clinical diagnosis, and
warrant the treatment and end results. Records must include the following:
a. Personal data:
1) Name
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2) Address, phone number(s), and how to contact
3) Age
4) Sex
5) Marital status (as required for State of Michigan)
6) Income Assessment
7) Unique client number
8) Race and ethnicity (as required for FPAR)
9) Medical history
10) Allergies recorded in a prominent, consistent location
b. Physical exam
c. Documentation of clinical findings, diagnostic/therapeutic orders
1) Laboratory test results and follow-up done for abnormal results
2) Treatments and special instructions
3) Documentation of continuing care, referral and follow-up
4) Documentation of scheduled revisits
d. Contraceptive method chosen by the client
e. Informed consents
f. Documentation of all counseling, education, and social services given
g. Documentation of deferrals, reason for deferral, and refusal of services
h. Date and signature of clinician or health professional for each entry, including
documentation of telephone encounters of a clinical nature.
1) Signature includes name and title of provider
2) A signature log, if full name and title are not used in medical record
i. A confidentiality assurance statement in the client's record.
j. A list of identified problems should be maintained to facilitate continuing
management and follow-up.
3. Confidentiality and Release of Records
A system must be in place to maintain confidentiality of client records.
a. A confidentiality assurance statement must appear in the client's record.
b. HIV, mental health, and substance use information must be handled according to
state law.
c. The written consent of the client is required for the release of personally identifiable
information, except as may be necessary to provide services to the client or as
required by law, with appropriate safeguards for confidentiality.
1) Consent form for release of information, signed by the client, specifies to whom
information may be disclosed.
2) Only the specific information requested may be released.
d. Information collected for reporting purposes must be disclosed only in summary,
statistical, or other form which does not identify individuals
e. Upon request, clients transferring to other providers must be provided with a copy or
summary of their record to expedite continuity of care.
f. Upon request, clients must be given access to their medical record
E. Quality Improvement
Sub-recipient agencies must have a system in place that provides for the ongoing evaluation
for conducting quality improvement.
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1. The quality improvement system should include the selection and measurement of
activities of at least one quality measure such as suggested measures on table 4 in the
QFP on page 24.
2. The quality improvement system must include the following elements:
a. A tracking system that identifies clients in need of follow up and/or continuing care
must be in place. (Referrals and Follow-up)
b. A system to assure that professional licenses and CPR certifications are current must
be in place. (Personnel & Emergencies)
c. Medical Audits to determine conformity with agency protocols, current standards,
and acceptable medical practices must be conducted quarterly by the medical
director.
1) Minimum of two to three charts per clinician must be reviewed by the medical
director quarterly.
d. Chart Audits/ Record Monitoring to determine completeness and accuracy of the
medical record must be conducted at least quarterly by the quality assurance
committee or identified personnel.
1) Chart audits must represent a minimum of three percent (3%) of the agency’s
quarterly caseload, randomly selected and reviewed by staff.
2) All clinical sites should be represented in the sampling.
3) Topic audits are strongly suggested.
e. Clinical protocols and procedures must be reviewed and signed annually by the
medical director.
f. Infection control policies and procedures reflecting current CDC recommendations
and OSHA regulations must be in place.
g. Laboratory audits to assure quality and CLIA compliance must be in place.
h. Equipment maintenance and calibration must be documented. (Equipment and
Supplies)
i. A process to implement corrective actions when deficiencies are noted must be in
place.
3. Sub-recipient agency quality improvement systems should include:
a. Annual peer review of all clinician/providers should be conducted. (Personnel)
b. Regularly scheduled staff meetings to update and/or review medical or service
delivery topics. Minutes should be kept of these meetings.
c. Routine check of emergency drugs and supplies
d. A process to elicit consumer feedback should be in place.
e. Periodic review of forms used by the agency for completeness and applicability
f. Routine monitoring of critical incident/occurrence reports
g. Periodic review of credentials of contracted laboratories
h. Periodic patient flow analysis
i. Periodic review of provider liability insurance coverage.
j. Periodic monitoring for reliability and accuracy of the client data system to assure
program performance, reporting, quality care, and generation of revenues. The
following components should be monitored:
1) Missing user data
2) Coding errors
3) Data outcome
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4. A Quality Improvement Committee should be in place. This committee should meet
monthly to discuss quality assurance issues and to make recommendations for corrective
action when deficiencies have been noted.
a. If a formal Quality Improvement Committee is in place, minutes should be kept of all
committee meetings.
b. The function of the Quality Improvement Committee may be assumed by an in-house
nursing or medical advisory committee with ongoing documentation of quality
improvement activities.
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SECTION IV
Program Monitoring
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Accreditation and Program Site Reviews
ACCREDITATION AND SITE REVIEWS FOR TITLE X FAMILY PLANNING
PROGRAMS
The MDHHS Title X Family Planning Program contracts with several types of providers to
provide Family Planning Title X grant services, including: local public health departments,
Planned Parenthood affiliates, hospital-based clinic sites, and private non-profit health providers.
For contracting and accreditation purposes, these providers are divided into two categories: local
public health departments and private non-profit sub-recipients. Both categories of sub-recipients
are reviewed using the Minimum Program Requirements (MPRs), regulatory requirements, and
OPA Title X Program Guidelines.
The MDHHS Title X Family Planning Program Standards and Guidelines is the primary
resource that outlines what is needed to meet Title X program requirements. The following
resources are consistent in these program expectations: The Federal Register Title X [42 CFR
Part 59, Subpart A], the Family Planning Statute which defines the legislative requirements for
the program. The OPA Title X Program Guidelines, consisting of Program Requirements for
Title X Funded Family Planning Projects, 2014 and Providing Quality Family Planning Services,
2014 (QFP) is the guidance issued to grantees to assist with implementation of these
requirements. These are available on the OPA website and in the federal resource section of this
document. The MDHHS Title X Family Planning Standards and Guidelines provide the most
detailed and specific expectations, taking into account Michigan laws and Michigan specific
requirements.
Accreditation Reviews for Local Public Health Department Family Planning Programs
All Title X sub-recipients have a comprehensive program review every three years to assure that
MDHHS supported family planning service sites in compliance with Title X regulations and are
managed effectively.
MDHHS contracts with Michigan Public Health Institute (MPHI) for the Michigan Local Public
Health Accreditation Program to coordinate comprehensive accreditation site reviews for all
local public health departments on a three year cycle. For local public health departments that
provide family planning services, the required Title X program site reviews are incorporated into
the Michigan Local Public Health Accreditation process. This is accomplished through
collaboration between the MDHHS Family Planning Program and the MPHI Local Public Health
Accreditation Program to coordinate the program review process for these sub-recipients. All
family planning program areas: administration, finance, clinical services and community
outreach and education are reviewed. For more information about the accreditation program see:
https://accreditation.localhealth.net/
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Program Site Reviews for Private Non-Profit Title X Family Planning Programs
Private non-profit Title X sub-recipients also undergo a comprehensive program review
conducted by the MDHHS Family Planning Program staff every three years. The program site
review is conducted to assure that MDHHS supported family planning service sites are managed
effectively, and are in compliance with federal Title X regulations. All program areas are
reviewed: administration, finance, clinical services and community outreach and education.
Methods
Both local health departments and private non-profit programs are reviewed by the same
standards of performance, compliance with the MPRs. All programs are reviewed using the same
tool and indicator guide.
Reviews of private non-profit sub-recipients are coordinated by the MDHHS Family Planning
Program staff. Local public health department sub-recipient program reviews are coordinated
through MPHI and MDHHS Family Planning staff. All sub-recipients submit their required pre-
materials directly to the MDHHS Family Planning Program six weeks prior to the site review.
Multiple services sites operated by a sub-recipient program may be visited during the process.
The MDHHS Family Planning Program review team consists of an administrative reviewer and a
clinical reviewer. The clinical reviewer is responsible for reviewing the clinic service portion of
the program including clinic protocols, contraceptive supplies, clinic observation and medical
review; and the administrative reviewer, the administrative portions of the program including,
policy review, observation, , community outreach and education, staff training, billing and
collections, and data collection processes.
Process
The following are steps in the site review process:
1. The MPR Indicator Guide for Family Planning, list of required Pre-Materials and Fiscal
Questionnaire are available at the MDHHS Family Planning website or on the MPHI Local
Public Health Accreditation website:
a. http.//www.michigan.gov/familyplanning
b. https://accreditation.localhealth.net/
2. Pre-Materials are to be submitted to the MDHHS Family Planning program at six weeks
prior to the scheduled review. The materials may be submitted either electronically or
mailed in a storage drive, or hard copy.
3. Unless otherwise requested by the program, the family planning coordinator serves as the
contact with MDHHS for the review process.
4. Agencies have the option to request a pre-accreditation conference call or meeting to ask
questions as they prepare for the site review.
5. The on-site program review is a two day process. Programs must have at least one clinic
session scheduled during the visit to facilitate the evaluation of administrative and clinical
components of the program. Programs are encouraged to schedule clinic sessions on the
initial day of the site review, if there are not clinics on both days.
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a. Upon request an entrance pre-conference can be scheduled. The pre-conference occurs
immediately at the beginning of the review to enable reviewers and program staff to meet
prior to beginning the review. The program may include any staff person who will be
able to provide information regarding clinical, administrative, education or financial
aspects of the program. This is an opportunity for the reviewers to meet program
personnel and get acquainted with the building, schedules, etc. It is a time for program
staff to make reviewers aware of individual characteristics of the program and
organization, as well as clarify the review process.
b. The exit conference is an opportunity for discussion between the reviewers and the
program staff regarding the general findings of the review. Health department programs
request an exit conference through MPHI, if desired. Private non-profit programs have
the opportunity to set the exit conference at the beginning of the review as logistical
items are being discussed.
c. Completed program review reports for local health department programs are submitted
within one week to MPHI and the local health department is notified that the compiled
on-site review report has been posted on the Local Public Health Accreditation Program
website within 30 days of the on-site review. Completed program review reports for
private non-profit family planning programs are received from MDHHS within 30 days.
Any indicator that was not met is identified in the report with recommendations for
correction. The report may also include commendations and recommendations for
program improvement. Corrective plans of action must be submitted and accepted for all
unmet indicators.
6. Corrective plans of action (CPA) submission and deadlines for local health department
sub-recipients are coordinated through MPHI. Private non-profit programs submit their
corrective action plans directly to the MDHHS Family Planning program. Technical
assistance is available to assist with developing the plans from MDHHS Family Planning
consultants.
a. CPAs are due within sixty days of the final day of the review, approximately 30 days
following receipt of the report.
b. Local health department programs submit their corrective action plans to MPHI and
any requested support materials to MDHHS family planning review staff.
c. Private non-profit programs submit their corrective action plans and requested
support materials directly to MDHHS family planning reviewers.
d. Plan may be approved with no further action needed, with conditions such as
subsequent site visit or submission of support materials to MDHHS, or may be
rejected with revisions required.
e. Implementation of CPA must be completed within one year of the review to continue
accreditation.
TECHNICAL ASSISTANCE AND MONITORING VISITS
Sub-recipient agencies are visited during the year prior to the accreditation/site review (3 year
review) or approximately one year following a site review. These visits are to provide technical
assistance and to monitor progress in areas needing improvement identified during the previous
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accreditation/site review. This is done to assure that those areas have been corrected to confirm
Title X compliance.
In addition, program issues and changes are discussed at these visits and any technical assistance
requested by the agency is provided.
MDHHS PROGRAM AUDITS
The Bureau of Audit, Reimbursement, and Quality Assurance is responsible for conducting
financial audits of one third of sub recipient agencies each year and managing Single Audit
information sent in by third party auditors for agencies expending over $750,000 in Federal grant
funding. (Section I, page 56, 57)
There is one full time audit position assigned to the Family Planning unit to conduct fiscal audits
and to ensure Title X fiscal policies are being followed. The audits verify that Title X activities
are separate and distinct from non-Title X activities and proper financial reporting in accordance
with contractual and regulatory requirements.
The audit staff uses a comprehensive procedural checklist to test various financial areas of the
grantee. The audit results are compiled into a preliminary report for grantee review and a
response on corrective action measures. Once the reply is reviewed, a final report is issued with
recommendations. The audits are entered into an audit tracking system for future reference and
monitoring. Program consultants review sub-recipient agency financial audits and findings as
part of the comprehensive program review conducted every three years.
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SECTION V
MDHHS and National Title X Training Programs
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MDHHS COORDINATORS MEETING
Two regional Family Planning Coordinators Meetings are held annually to update all family
planning coordinators throughout the State. These face-to-face meetings provide a venue for
sharing pertinent information related to program and policy issues or changes. In addition,
essential information is presented from the Michigan Department of Health and Human Services
management, administrative and clinical consulting staff regarding clinical and management
issues pertinent to Title X Family Planning clinics. The Family Planning Coordinators Meetings
are also used to assess ongoing and future training needs for the network.
These two regional meetings are coordinated by the Michigan Public Health Institute (MPHI)
and the Michigan Department of Health and Human Services. The regional meeting format
replaces a single webinar format that allows for broad participation of agency coordinators
across the state while addressing costs and reduced travel funds as well as providing needed
networking among programs.
MICHIGAN ANNUAL FAMILY PLANNING UPDATE
The Michigan Department of Health and Human Services (MDHHS) Title X Family Planning
Program sponsors a training workshop for anyone involved with family planning service. The
scope of the audience is wider than the Annual Coordinator’s Meetings. The conference follows
a workshop format and is scheduled for two days.
This annual conference is called the Michigan Family Planning Update. The conference location
is rotated geographically to provide access to all areas in Michigan. Expert presenters are invited
to address a variety of topics in both general session and workshop formats. Continuing
education and contact hours are available where possible. In addition, MDHHS administrative,
clinical and management staff are available to provide pertinent program information. This
conference also provides an important venue for family planning providers, administrators and
staff to network. Selected sessions, reflecting OPA training priorities, are videotaped and
archived on the MPHI website for family planning providers and staff who are unable to attend
the conference. https://events.mphi.org/family-planning-update/
ADDITIONAL MDHHS STAFF AND SUB-RECIPIENT TRAININGS
In addition to the coordinator meetings and family planning conference, MDHHS in cooperation
with MPHI, provides a number of other training opportunities related to family planning
throughout the year. These trainings are provided through a combination of face to face
workshops and webinar offerings. Continuing education and contact hours are available where
possible.
MPHI publishes a calendar online with all the educational offerings for the year. This calendar
is available on the MPHI website. Visit the MPHI website for more information and registration:
https://events.mphi.org/calendar/
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Participant evaluations are collected after each workshop and training to provide information
from the previous year for planning future meetings and trainings. Trends in requests for
information, suggestions for improvement and for future trainers, as well as other information
obtained through these evaluations are considered in the planning.
NATIONAL MEETINGS, CONFERENCE AND NATIONAL TRAINING CENTERS
(NTCS)
The National Family Planning Program authorized in 1970 as Title X of the Public Health
Service Act (P.L.910572). The nationally funded Title X program is administered by the Office
of Family Planning in the Office of Population Affairs within the Department of Health and
Human Services. Information about the Family Planning program is available on the OPA
Website at: http://www.hhs.gov/opa/title-x-family-planning/. The Family Planning Program is
administered through ten Public Health Service Regional Offices throughout the United States.
Michigan is part of Region V and the MDHHS Family Planning Program obtains program
consultation and direction through the Region V Program Consultant located in Chicago, Illinois.
The Title X program, under Section 1003, provides training grants for personnel working in
family planning services projects, with the purpose of promoting and improving the delivery of
family planning services. Until 2012, each of the ten Regional Program Offices administered a
training grant to focus on staff needs within their region. In 2012, in order to more effectively
meet Title X training needs in a rapidly evolving health care environment, OPA moved from a
regional to a national training model. OPA is currently funding two centers:
1. The Family Planning National Training Center (FPNTC), operated by JSI Research
Training Institute (JSI) and partnering with the World Health Organization Collaborating
Center and the University of North Carolina (UNC) National Implementation Research
Network. FPNTC offers Title X providers evidence-based and best practice trainings.
https://www.fpntc.org/
2. The National Clinical Training Center (CTC) provides clinical training for nurse
practitioners, certified nurse midwives, physicians, and physician assistants. The CTC
develops annual national family planning training symposiums, a national biennial
reproductive health conference, and clinical webinars including "virtual coffee breaks."
http://www.ctcfp.org/
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THE MICHIGAN FAMILY PLANNING ADVISORY COUNCIL (FPAC)
Overview
The Michigan Family Planning Advisory Council (FPAC) is a group of diverse individuals
committed to improving access to family planning services for the people of Michigan. Having
the skills and resources to plan the timing and size of families improves birth outcomes, protects
the health of parents, and reduces the likelihood of that family living in poverty. Towards that
end, individuals representing the state government, local health departments, Planned
Parenthoods, hospitals, adolescent health centers, advocacy agencies, social workers, and
community members have joined together to enhance access to family planning services.
History
Michigan has received Title X of the Public Health Services Act (Title X) funding since 1972.
The Title X Program is the only federal program devoted solely to the provision of family
planning and reproductive health care. A requirement of the Title X program is to have
community participation in the program by: 1) persons broadly representative of all significant
elements of the population served; and 2) persons knowledgeable about the community’s needs
for family planning services. Since 1972, Michigan has met this requirement through the
statewide FPAC. At that time, Title X providers were one of the only sources of family planning
services for low-income men and women in Michigan. Today, federally qualified health centers
proliferate in Michigan and provide low-cost health services including family planning. In 2006,
Michigan Medicaid was approved for a demonstration waiver that expanded family planning
coverage to eligible females with incomes up to 185 percent of the federal poverty level (FPL),
called Plan First! In 2014, Michigan received approval to implement the Affordable Care Act’s
(ACA) Medicaid expansion through a Section 1115 demonstration waiver, called the Healthy
Michigan Plan. Under this plan, the state provides Medicaid coverage to all newly eligible adults
with income up to and including 138% of the federal poverty level. Over 600,000 adults are
enrolled in coverage through the waiver. Plan First! was phased out in June 2016.
In 2009, the FPAC completed a strategic planning process. The group decided it would benefit
the state to broaden their focus from only Title X programs to include other sources of family
planning services in Michigan. The Title X programs remain the cornerstone of family planning
services for low-income Michigan men and women and remain a focus. The FPAC
acknowledges the philosophy in the Title X regulations and continues to seek members
representing the population served and knowledgeable about the state’s need for family planning
services.
Shared Mission
Through collaborative leadership and advocacy, the Family Planning Advisory Council (FPAC)
supports and improves the reproductive health of Michigan residents.
Shared Vision
The FPAC is a highly visible and sought after partnership that assures innovative and quality
policies, programs and services benefiting generations to come.
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Key Priorities
The FPAC:
• Develops and shares our identity.
• Builds the right infrastructure for maximum success.
• Establishes strategic partnerships with local, state and national networks.
• Coordinates a strategic annual policy agenda.
• Maximizes existing or leverage new resources for programs that provide family planning.
• Provides leadership for quality service delivery.
• Utilizes state-of-the-art technology to assure family planning information is available.
Participants
Current membership includes individuals representing the state government, local health
departments, Planned Parenthoods, hospitals, adolescent health centers, advocacy agencies,
social workers, and community members.
Structure
The FPAC meets three times per year in Lansing, with a conference call option to increase
accessibility. The FPAC agenda is carried forward through the work of the following task forces
under the leadership of the Executive Committee.
• Policy Advancement Task Force
Develops and coordinates a strategic policy agenda for family planning services
• Medical Advisory Sub-Committee
Provides leadership on delivery of quality services in reproductive health
