[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54458-54462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21241]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Final Policy: Updates to Uniform Standard for Waiver of the Ryan 
White HIV/AIDS Program Core Medical Services Expenditure Requirement

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice of final policy.

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SUMMARY: The Ryan White HIV/AIDS Program (RWHAP) statute of the Public 
Health Services Act requires that RWHAP Part A, B, and C recipients 
expend not less than 75 percent of Parts A, B, and C grant funds on 
core medical services for individuals with HIV/AIDS identified and 
eligible under the statute, after reserving statutory permissible 
amounts for administrative and clinical quality management (CQM) costs. 
The statute also grants the Secretary of HHS authority to waive this 
requirement if certain requirements are met. HRSA has simplified the 
process for RWHAP Part A, B, and C recipients to request a waiver of 
the core medical services expenditure amount requirement by replacing 
HRSA Policy Number 13-07, ``Uniform Standard for Waiver of Core Medical 
Services Requirement for Grantees Under Parts, A, B, and C'' with 
Policy Notice 21-01, ``Waiver of the Ryan White HIV/AIDS Program Core 
Medical Services Expenditure Requirement.''

DATES: The final policy is effective on October 1, 2021.

FOR FURTHER INFORMATION CONTACT: Lieutenant Commander Emeka Egwim, U.S. 
Public Health Service, Senior Policy Analyst, Division of Policy & 
Data, HRSA, HIV/AIDS Bureau, 5600 Fishers Lane, Rockville, MD 20857, 
Phone: (301) 945-9637 or by emailing [email protected]. When 
requesting information, please include this Federal Register notice 
title for reference.

SUPPLEMENTARY INFORMATION: The RWHAP statute also grants the Secretary 
of HHS authority to waive this requirement for RWHAP Parts A, B, or C 
recipients if a number of requirements are met and a waiver request is 
submitted to HRSA for approval. RWHAP Part A, B, and C core medical 
services waiver requests--if approved--are effective for a 1-year 
budget period, and apply to funds awarded under the Minority AIDS 
Initiative.
    Currently, for a core medical services waiver request to be 
approved, (1) core medical services must be available and accessible to 
all individuals identified and eligible for the RWHAP in the 
recipient's service area within 30 days, without regard to payer 
source; (2) there cannot be any AIDS Drug Assistance Program (ADAP) 
waiting lists in the recipient's service area; and (3) a public process 
to obtain input on the waiver request from impacted communities, 
including clients and RWHAP-funded core medical services providers, on 
the availability of core medical services and the decision to request 
the waiver must have occurred. The public process may be a part of the 
same one used to seek input on community needs as part of the annual 
priority setting and resource allocation, comprehensive planning, 
statewide coordinated statement of

[[Page 54459]]

need, public planning, and/or needs assessment processes.
    HRSA has simplified the waiver request process for RWHAP Parts A, 
B, and C recipients by revising and replacing HRSA Policy Number 13-07: 
Uniform Standard for Waiver of Core Medical Services Requirement for 
Grantees Under Part, A, B, and C. The changes reduce the administrative 
burden for recipients by lessening the documentation they must submit 
to HRSA when requesting a waiver. Under this final policy, recipients 
are required to submit a one-page ``HRSA RWHAP Core Medical Services 
Waiver Request Attestation Form'' to HRSA in lieu of the multiple 
documents previously required to submit a waiver request.
    HRSA also revised the waiver request submission deadlines. This 
final policy, ``Waiver of the Ryan White HIV/AIDS Program Core Medical 
Services Expenditure Requirement,'' replaces HRSA Policy Number 13-07 
effective October 1, 2021.
    In administering the RWHAP, HRSA continually evaluates its policies 
and processes, and considers making updates where necessary to ensure 
programmatic efficiency while facilitating recipients' ability to 
provide care and support services to people with HIV. To inform its 
policy evaluation and development processes with perspectives 
representative of the communities served by the RWHAP, HRSA welcomes 
and considers input from stakeholders of the RWHAP, including 
recipients, providers, people with HIV, and the general public. To that 
end, on April 20, 2021, HRSA sought public input when it published the 
proposed updates to the waiver request process for RWHAP Parts A, B, 
and C recipients in the Federal Register (86 FR 20500), and released a 
listserv message informing stakeholders where to access and review the 
Federal Register notice. In addition, during the April 27, 2021, ``HAB 
You Heard'' RWHAP recipient webinar, HRSA conducted a walkthrough of 
the proposed policy, comparing and contrasting it to the existent 
policy outlined in HRSA Policy Number 13-07. Subsequently, on August 
20, 2021, HRSA published a Federal Register notice for 30-day public 
comment period, and submitted the ICR to OMB for review and approval.

Overview of Public Comments

    In response to the proposed policy published in 86 FR 20500, HRSA 
received 52 responses from stakeholders. The vast majority of 
respondents were individuals from the general public, followed by RWHAP 
recipients and HIV patient care advocacy organizations. HRSA considered 
all feedback in the finalization of the policy, and a discussion of the 
public comments is included below.

Discussion of Public Comments on the Proposed Policy

Availability of Core Medical Services, ADAP Waiting Lists, and Evidence 
of a Public Process

    Public Comment: Commenters were unanimously supportive of 
submitting a one-page attestation form in lieu of the multiple pages of 
supporting documentation required per HRSA Policy Number 13-07 because 
it would reduce administrative burden. They were equally supportive of 
the stipulation that, if requested, recipients would need to submit 
supportive documentation to HRSA if requested.
    Response: HRSA appreciates the comments and agrees the new policy 
will reduce burden for recipients, as well as for HRSA as it reviews 
the waiver applications. HRSA is finalizing the policy as proposed. As 
such, when submitting waiver requests, RWHAP recipients will only need 
to submit the one-page ``HRSA RWHAP Core Medical Services Waiver 
Request Attestation Form'' to HRSA in lieu of multiple documents 
currently required to submit a waiver request. HRSA may request 
additional information or supporting documentation. HRSA approximates 
this process would require 4 hours per response, representing a 
reduction of 1.5 hours when compared to the current process, or a total 
of 88 hours across all recipients expected to submit a waiver 
application.

Submission Deadlines

    Public Comment: Commenters were supportive of the proposed changes 
regarding waiver request submissions deadlines. One commenter expressed 
some concern that specific submission deadlines may reduce flexibility 
for some recipients and may not take into account the urgency of a 
potential waiver in the case of an emergency or unexpected situation on 
the part of the recipient. The commenter recommended that HRSA 
adequately advertise this tenet of the policy and evaluate the 
deadlines to ensure this change does not adversely impact recipients.
    Response: HRSA will finalize the policy as proposed by requiring 
specific submission deadlines. RWHAP Part A recipients will need to 
submit the waiver request as an attachment with the grant application 
or non-competing continuation (NCC) progress report. RWHAP Part B 
recipients will need to submit the waiver request either in advance of 
the grant application, with the grant application, with the mandatory 
NCC progress report, or up to 4 months into the grant award budget 
period for which the waiver is being requested. RWHAP Part C recipients 
will need to submit the waiver request as an attachment with the grant 
application or the mandatory NCC progress report. HRSA thanks the 
commenters for their input, and will monitor the impact of the new 
policy on the RWHAP in order to ensure recipients' ability to timely 
submit waiver requests and their ability to provide care and support 
services to people with HIV.

Concluding Points

    HRSA continues to find opportunities to streamline its policies and 
processes to facilitate RWHAP recipients' ability to continue to 
deliver quality care and support services to people with HIV, while 
increasing HRSA's efficiency in administering the program. Given the 
participation of RWHAP stakeholders in the public process, HRSA 
believes HRSA Policy Number 21-01 titled ``Waiver of the Ryan White 
HIV/AIDS Program Core Medical Services Expenditure Requirement'' meets 
the overall goal and objective of the RWHAP, and is inclusive of the 
perspectives of stakeholders, while reducing burden to RWHAP 
recipients. HRSA expects a period of adjustment to the new process. To 
that end, HRSA will provide timely technical assistance and other 
resources to assist recipients with the transition to and 
implementation of the final policy. Recipients are encouraged to 
contact HRSA at [email protected] for questions or feedback on the 
new process.
    HRSA remains committed to supporting RWHAP recipients in their 
provision of care and support services to people with HIV. The 
finalization of HRSA Policy Number 21-01, which reduces burden for 
recipients requesting a waiver of the Core Medical Services expenditure 
requirement, is another step indicative of this commitment.
    The final policy is set forth below. Upon its Effective Date of 
October 1, 2021, the policy replaces HRSA Policy Number 13-07.

[[Page 54460]]

Waiver of the Ryan White HIV/AIDS Program Core Medical Services 
Expenditure Requirement

Policy Notice 21-01

Replaces Policy Number 13-07

Scope of Coverage

HRSA HIV/AIDS Bureau RWHAP Parts A, B, and C

Requirements

    A HRSA RWHAP Part A, B, or C recipient must meet a number of 
requirements and submit a waiver request to HRSA to receive a waiver of 
the core medical services expenditure requirement. First, core medical 
services must be available and accessible to all individuals identified 
and eligible for the RWHAP in the recipient's service area within 30 
days. Access to core medical services must be without regard to payer 
source and without the need to spend at least 75 percent of funds 
remaining from the recipient's RWHAP award after statutory permissible 
amounts for administrative and CQM are reserved. Second, the HRSA RWHAP 
recipient must ensure there are no ADAP waiting lists in its service 
area. Third, a public process to obtain input on the waiver request 
must have occurred. This process must seek input from impacted 
communities, including clients and RWHAP-funded core medical services 
providers on the availability of core medical services and the decision 
to request the waiver. The public process may be a part of the same one 
used to seek input on community needs as part of the annual priority 
setting and resource allocation, comprehensive planning, statewide 
coordinated statement of need, public planning, and/or needs assessment 
processes.

Requesting a Waiver

    To request a waiver, the Chief Elected Official, Chief Executive 
Officer, or a designee of either must complete and submit the HRSA 
RWHAP Core Medical Services Waiver Request Attestation Form (appended 
below) to HRSA. The form should be submitted according to the 
applicable deadlines and methods for submission outlined below. By 
completing and submitting this form, the Chief Elected Official, Chief 
Executive Officer, or a designee of either attests to meeting the 
requirements outlined above and agrees to provide supportive evidence 
to HRSA upon request. No other documentation is required to be 
submitted with the HRSA RWHAP Core Medical Services Waiver Request 
Attestation Form.

Deadlines for Submitting Waiver Requests

HRSA RWHAP Part A Waiver Requests

    A HRSA RWHAP Part A recipient's request for a waiver should be 
submitted as an attachment with the grant application or the mandatory 
NCC progress report, if applicable. In each case, waiver requests do 
not count towards the submission page limit. Requests for waivers 
should not be submitted prior to the grant application or mandatory NCC 
progress report, nor should they be submitted after the start of the 
grant award budget period for which the waiver is being requested.

HRSA RWHAP Part B Waiver Requests

    A HRSA RWHAP Part B recipient's request for a waiver may be 
submitted either in advance of the grant application, as an attachment 
to the grant application, with the mandatory NCC progress report, or up 
to 4 months into the grant award budget period for which the waiver is 
being requested.

HRSA RWHAP Part C Waiver Requests

    A HRSA RWHAP Part C recipient's request for a waiver should be 
submitted as an attachment to the grant application or the mandatory 
NCC progress report. Requests for waivers should not be submitted prior 
to the grant application or mandatory NCC progress report, nor should 
they be submitted after the start of the grant award budget period for 
which the waiver is being requested.

Methods for Submitting Waiver Requests

    Waiver requests submitted with grant applications must be submitted 
through www.grants.gov. Waiver requests submitted with the mandatory 
NCC progress report must be submitted through the HRSA Electronic 
Handbooks (EHB). For waiver requests that are not submitted with grant 
applications, and not submitted with the mandatory NCC progress report, 
a recipient must notify its HRSA project officer of its intention to 
request a waiver. The project officer will initiate a Request for 
Information in the EHB. The recipient must respond to the EHB task 
consistent with the deadlines for submitting waiver requests outlined 
above.

Waiver Review and Notification Process

    HRSA will review requests and notify recipients of waiver approval 
or denial within 4 weeks of receipt of the request.
    Approved core medical services waivers will be effective for the 1-
year budget period for which it is approved; recipients must submit a 
new request for each budget period. A recipient approved for a core 
medical services waiver is not required to implement the approved 
waiver if it is no longer needed.
    This guidance does not have the force and effect of law and is not 
meant to bind the public in any way, except as authorized by law or as 
incorporated into a contract. It is intended only to provide clarity to 
the public regarding existing requirements under the law or agency 
policies.
BILLING CODE 4165-01-P

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Diana Espinosa,
Acting Administrator.
[FR Doc. 2021-21241 Filed 9-30-21; 8:45 am]
BILLING CODE 4165-15-C