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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations
removed completely because of the additional reporting requirements it creates. Another comment requested that the Department only require grantees to submit the additional information required by this provision for subrecipients during regular reports but not during the initial application.
The comment expressed a concern that for large Title X networks, providing a description of all referral agencies and individuals, and outlining collaborations with each subrecipient, will still pose a significant burden for Title X grantees, particularly at the time of application when applicants are often afforded 60 days or less to apply. Many other comments requested that the Department revise the language in this provision to focus only on subrecipients and not referral agencies due to high burden of reporting given the size of grantee networks and the high number of possible referrals made by individual sites. One comment stressed that under the 2000 regulations, past grantees were required to monitor each organization and ensure that their clinic sites had appropriate referrals, that they were available to all clinic personnel, and that clients medical charts reflected appropriate referrals given and followup performed. However, grantees were not required to gather every referral source and report this information to HHS. This requirement will likely create an administrative burden that could be accomplished through HHS monitoring of grantees.
Response: It is clear from the comments received that the proposed requirements in 59.5a13 are unnecessarily burdensome for grantees and will result in Title X staff having to spend valuable time on administrative reporting that could otherwise be spent providing services to clients. The Department agrees that monitoring how grantees are involving and monitoring their subrecipients in their project and the composition of grantee referral networks can be achieved through the Departments existing grantee compliance monitoring system.
Departmental grants regulations at 45
CFR 75.352 already document the requirements for pass-through entities and specify the reporting required of grantees for all pass-through entities.
Furthermore, this provision was a part of the 2019 rule that is being rescinded as a whole because it was a set of interrelated requirements that did not promote the public health or solve any Title X compliance concerns.
Given the challenges noted with this provision and the additional reporting burden it would place on grantees, the
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Department has decided to remove 59.5a13 from the 2021 final rule.
59.5b1 Provide Medical Services Related to Family Planning In the NPRM, the Department proposed revising section 59.5b1 of the 2000 regulations to acknowledge that consultation for medical services related to family planning can be provided by healthcare providers beyond the physician. Specifically, the NPRM stated, Provide for medical services related to family planning including consultation by a healthcare provider, examination, prescription, and continuing supervision, laboratory examination, contraceptive supplies and necessary referral to other medical facilities when medically indicated, and provide for the effective usage of contraceptive devices and practices.
The proposed revision acknowledged that consultation for healthcare services related to family planning may be by a physician, but may also be by other healthcare providers, specifically acknowledging participation by physician assistants and nurse practitioners.
Comments: The Department received numerous comments supporting this revised provision, specifically in support of the recognition that a broad range of healthcare providers, in addition to physicians, have an important role to play in providing medical services related to family planning. Comments expressed agreement that other clinicians often play an important role in providing family planning counseling and other services. In addition, numerous comments asked the Department to clarify that this provision includes a broader range of healthcare providers beyond just physician assistants and nurse practitioners, as noted in the preamble of the NPRM. One comment asked that the Department use the definition of Clinical Services Provider from FPAR. Many other comments stated that it is important to note that consultation by a healthcare provider is not and should not be limited only to the examples cited by HHS, as these CSPs represent only one facet of healthcare providers in Title X
settings.
In addition to the numerous comments related to the array of healthcare professionals that are responsible for clinical service provision in Title X, the Department also received numerous comments asking for the language of this provision to be revised to clearly reflect telehealth as an acceptable service delivery modality. Several comments expressed
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the importance of telehealth, especially throughout the COVID19 pandemic, in allowing many Title X clients to continue to safely access essential services. Many comments expressed concern with the Departments use of the word telemedicine in the NPRM
instead of telehealth and felt that telehealth refers to a broader scope of remote healthcare services than telemedicine and includes non-clinical services like counseling and education.
Several comments specifically asked the Department to revise 59.5b1 to be clear within the regulation that family planning services can be provided in person or via telehealth. Other comments asked the Department to specify within the regulation that telehealth services can include audioonly modalities and expressed that all forms of telehealth modalities, including audio-only must be covered to remove any barriers of access for patients. One comment asked the Department to provide guidance to Title X grantees on how to use telehealth services to ensure access, equity, and quality.
Response: The Department appreciates the comments in support of this provision, especially those that recognize the role of a broader range of healthcare providers in delivering family planning services. It was never the Departments intention to imply that the only healthcare providers who could provide consultation under this provision were physician assistants and nurse practitioners. Physician assistants and nurse practitioners were included in the NPRM preamble to provide examples, but not to be exclusionary.
The Department agrees with comments recommending use of the definition of Clinical Services Providers from FPAR
to determine who is eligible as a healthcare provider under this provision and, as noted in the discussion related to Section 59.2 Definitions, is adding this definition to the final rule. The FPAR definition for Clinical Services Providers includes physicians, physician assistants, nurse practitioners, certified nurse midwives, and registered nurses with an expanded scope of practice who are trained and permitted by state-specific regulations to perform all aspects of the user male and female physical assessments recommended for contraceptive, related preventive health, and basic infertility care.
The Department agrees with the comments reiterating the importance of telehealth and the role of telehealth services in expanding access to services and advancing equity. The Department had always intended for the final rule to apply to family planning services
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