Guidance for Nondirective Pregnancy Counseling and Care for Pregnant Clients

The Final Rule requires that nondirective counseling be provided by physicians or advanced practice providers (APPs). (42 CFR § 59.14(b)(1)(i)). The Final Rule at 42 CFR § 59.2 defines APPs as a “medical professional who receives at least a graduate level degree in the relevant medical field and maintains a license to diagnose, treat, and counsel patients.” There is, however, no requirement that the physician or APP provide the nondirective counseling on site. Therefore, it is possible to arrange to have the nondirective pregnancy counseling be provided via phone or other virtual meeting where the physician or APP can speak directly with the client. (Please see answer to question 2 for additional options.)

1. In the action plan and statement for compliance requirements could RNs do the nondirective counseling and if there is a question of a medical nature that the RN cannot answer, the client would be referred to an advanced practice provider. If there is a way to get a waiver for RNs, what would the process for doing so look like

   The Final Rule at 42 CFR § 59.14(b)(1)(i) states: “The Title X provider may also choose to provide the following counseling and/or information…Nondirective pregnancy counseling, when provided by physicians or advanced practice providers… .” Thus, the provision of nondirective counseling by an RN does not comply with the Title X regulations (see below for further options for compliance with nondirective pregnancy counseling regulations).

2. Should we change our clinic schedule to only providing pregnancy tests on the days that a physician or an advanced practice provider is available?

   It is not necessary to change clinic schedules to provide only pregnancy tests on the days that a physician or an advanced practice provider (APP) is available. The staff member responsible for pregnancy test appointments may perform the test, confirm the pregnancy, and provide basic factual acknowledgement of the options available to the client. Any questions or conversation beyond confirming pregnancy and providing basic factual acknowledgement of the options available to the client, must be referred to a physician or an advanced practice provider (definition provided in § 59.2). The staff member who is seeing the client could also provide “a list of licensed, qualified, comprehensive primary health care providers (including providers of prenatal care)” to provide that counseling (42 CFR § 59.14(b)(1)(ii)). However, “neither the list nor project staff may identify which providers on the list perform abortion” (42 CFR § 59.14(c)(2)).

   In addition, the Final Rule permits, but does not require, nondirective pregnancy counseling to be a part of the Title X program. Such nondirective pregnancy counseling may only be provided by a physician or APP (42 CFR § 59.14(b)(1)(i)). Thus, a program could choose not to provide nondirective pregnancy counseling as part of the Title X project. Any clients requesting nondirective pregnancy counseling could be informed that this counseling is not part of the Title X project and could be referred to another program or health care provider who does provide this service.

3. Is there a requirement for nondirective counseling to be provider initiated or client initiated?

   The Final Rule places a high priority on preserving the family planning services provider/client relationship, thereby promoting optimal health for every Title X client. To preserve open communication between the client and the provider, the regulation permits, but does not require, nondirective pregnancy counseling. (42 CFR § 59.14(b)(1)(i)).

   If the provider chooses to provide nondirective pregnancy counseling, it is important for the provider to make available the opportunity to provide counseling and information to the client. Any counseling provided to the client should be tailored to the needs of the client. Clients should be encouraged to ask questions and engage in conversations with their provider in an environment that is conducive to this exchange.

4. Could we develop standing orders protocols from the providers and medical directors that would allow the already highly trained and experienced staff members to continue to provide pregnancy options counseling?

Guidance for Referral for Prenatal Care and Care of Pregnant Clients

5. Can staff members already highly trained in pregnancy options counseling continue to refer for prenatal care if they know that the patient wants to continue pregnancy?

   The Final Rule at 42 CFR § 59.14(b)(1) states that, “(1) Because Title X funds are intended only for family planning, once a client served by a Title X project is medically verified as pregnant, she shall be referred to a healthcare provider for medically necessary prenatal healthcare.” Thus, referral for prenatal care is required, and there are no restrictions on which personnel may refer for such care. The only restrictions in the rule are related to the provision of nondirective counseling: Section 59.14(b)(1)(i) states that the Title X provider may also choose to provide “(i) Nondirective pregnancy counseling, when provided by physicians or advanced practice providers.”

   Any staff member who is currently providing prenatal referrals is free to continue to provide that service according to the policies/procedures of the service site. In addition, the staff member who is seeing the client can also provide “a list of licensed, qualified, comprehensive primary healthcare providers (including providers of prenatal care)” (42 CFR § 59.14(b)(1)(ii)).

6. Can the person doing the pregnancy test still give prenatal vitamins if the test is positive?

   The Final Rule at 42 CFR § 59.14(b) states that, “Because Title X funds are intended only for family planning, once a client served by a Title X project is medically verified as pregnant, she shall be referred to a healthcare provider for medically necessary prenatal healthcare.” Such a referral is required since prenatal care is considered medically necessary to preserve the health of mother and child; such post-conception care, including the provision of prenatal vitamins, is not within the scope of services provided in a Title X project. However, a Title X provider is not prohibited from dispensing prenatal vitamins to a pregnant client at the location of the Title X clinic as long as such service is not provided in the context of the Title X project. Accordingly, dispensing prenatal vitamins would be up to the policies in place at the service site and not under Title X jurisdiction.

Guidance for Documentation of Required Services

7. What type of documentation is required in regards to family involvement? Can we check boxes on the electronic health record (EHR) form, such as, education or initiating/ maintaining a conversation with parents? If they are not ready to talk to their parents, do we have to state why they are not ready in their chart?

   The Final Rule at 42 CFR § 59.5 (a)(14) states that Title X projects must, “Encourage family participation in the decision to seek family planning services; and, with respect to each minor patient, ensure that the records maintained document the specific actions taken to encourage such family participation (or the specific reason why such participation was not encouraged).”

   The expectation is that family participation will be encouraged except where the minor is or may be the victim of child abuse or incest.

   In order to document compliance, providers can use the use EHR field to document that the clinical service provider and/or other appropriate project personnel discussed family participation with the minor client.

   The grantee may also provide sample documentation of progress notes for documenting counseling about family participation and documentation for why counseling was not provided, if applicable.

8. The rule requires that minors be counseled on how to resist coercion to engage in sexual activity; if a client is returning for a follow-up visit within a month and was counseled appropriately at the first visit, then would the full counseling be necessary again?

   The Final Rule at 42 CFR § 59.17(b)(1)(iii) states that, “A project may not receive funds under this subpart unless it provides appropriate documentation or other assurance satisfactory to the Secretary that it … [h]as in place and implements a plan to comply with State notification laws. Such plan shall include, at a minimum, policies and procedures that include … [p]rotocols to ensure that every minor who presents for treatment is provided counseling on how to resist attempts to coerce them into engaging in sexual activities…”

   In order to document compliance, providers can use the use EHR field to document that the clinical service provider and/or other appropriate project personnel counseled the minor client regarding sexual coercion. Routine follow-up visits would not require the same counseling to be provided again; however, that explanation should be documented in the chart.

9. Is this assurance expected from the grantee or do we also need to request that our subrecipients write the requested assurance?

   The Final Rule at 42 CFR § 59.13 states that, “A project may not receive funds under this subpart unless the grantee provides assurance satisfactory to the Secretary that the project does not provide abortion and does not include abortion as a method of family planning.” A written assurance must be submitted to OPA by the grantee on or before August 19, 2019, and should be signed by both the Authorizing Official and the Project Director. OPA requires that all grantees have a written agreement with any subrecipient who will be providing family planning services with Title X funds, which includes the obligation on the part of the subrecipient to comply with Title X requirements. However, subrecipients are not required to submit separate written assurances to OPA.

Guidance for Documentation of Required Services

10. Can you define what is meant by clear separation?

    The Final Rule at 42 CFR § 59.15 states: “In order to be physically and financially separate, a Title X project must have an objective integrity and independence from prohibited activities. Mere bookkeeping separation of Title X funds from other monies is not sufficient. The Secretary will determine whether such objective integrity and independence exist based on a review of facts and circumstances.”

    The Title X project can demonstrate clear financial separation through audit reports substantiating that Title X funds are not used in any way to support abortion-related services. Additionally, audit reports showing cost centers in different physical locations could be utilized to document the separation of Title X services areas from physical locations that provide abortion as a method of family planning. OPA plans to utilize its normal mechanisms that have been part of program reviews for many years and will work closely with any grantees to come into compliance.

11. If our subrecipient agency receives Title X funding but only implements at selected sites, are they bound by the Title X rule at their “non-Title X” supported sites?

    The Title X regulations are program and site specific, and apply only to sites receiving Title X funds. Therefore, subrecipients would not be bound by the Title X Final Rule at “non-Title X” supported sites.

12. If a Title X grantee or subrecipient shares a building with another program that does not receive Title X funding but provides services for pregnant women, is the other program subject to the Title X regulations?

    The Title X Regulations are program specific and require physical and financial separation of abortion services, including referrals for abortion as a method of family planning, from Title X services. However, other programs are not subject to Title X regulations.

13. If an agency could show that one room in their office as well as a staff member was paid for out of a different grant, could that room be used for pregnancy options counseling?

    Under the Final Rule, a Title X provider is permitted to provide nondirective pregnancy counseling, including counseling on abortion, but is not permitted to provide referrals for abortion as a method of family planning. Thus, there is no problem if the Title X provider is providing nondirective pregnancy counseling, even if that counseling includes nondirective counseling on abortion. It may not, however, provide a referral for abortion as a method of family planning.

    The Final Rule requires physical and financial separation of the Title X project from prohibited activities (e.g., abortion as a method of family planning). The Final Rule at 42 CFR § 59.15 states “In order to be physically and financially separate, a Title X project must have an objective integrity and independence from prohibited activities. Mere bookkeeping separation of Title X funds from other monies is not sufficient.” The grantee must ensure that the Title X supported project is separate and distinguishable from those other activities.

    Grantees should note that the obligation to comply with the financial separation is immediate and, consistent with OPA’s guidance on compliance action plans, should take steps to ensure compliance by September 18, 2019. Compliance with physical separation requirements contained in § 59.15, is not required until March 4, 2020. As stated in the rule “[t]he Secretary will determine whether such objective integrity and independence exist based on a review of facts and circumstances”; therefore, grantees should provide documentation relevant to this determination including:

    "(a) "The existence of separate, accurate accounting records;
    (b)The degree of separation from facilities (e.g.,treatment, consultation, examination and waiting rooms, office entrances and exits, shared phone numbers, email addresses, educational services, and websites) in which prohibited activities occur and the extent of such prohibited activities;
    (c) The existence of separate personnel, electronic or paper-based health care records, and workstations; and
    (d) The extent to which signs and other forms of identification of the Title X project are present, and signs and material referencing or promoting abortion are absent.”

    As HHS noted in the preamble to the Final Rule, it considers item (a) to be an element for consideration with respect to financial separation, while items (b), (c), and (d) address the requirement for physical separation. The physical separation will be decided on a case–by-case basis.