[Federal Register Volume 78, Number 101 (Friday, May 24, 2013)]
[Notices]
[Pages 31563-31566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Ryan White HIV/AIDS Program Core Medical Services Waiver; 
Application Requirements

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Final Notice with Opportunity for Comment

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SUMMARY: Title XXVI of the Public Health Service Act, as amended by the 
Ryan White HIV/AIDS Treatment Extension Act of 2009 (Ryan White Program 
or RWP), requires that grantees expend 75 percent of Parts A, B, and C 
funds on core medical services, including antiretroviral drugs, for 
individuals with HIV/AIDS identified and eligible under the statute. 
The statute also grants the Secretary authority to waive this 
requirement if there are no waiting lists for the AIDS Drug Assistance 
Program (ADAP) and core medical services are available to all 
individuals identified and eligible under Title XXVI in an applicant's 
service area.
    Prior to this policy announcement, grantees seeking a waiver of the 
75 percent requirement have been required to submit core medical 
services waiver requests at the same time as the annual

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grant application. Recognizing RWP grantees' request for additional 
flexibility in the timing of waiver applications, the Health Resources 
and Services Administration (HRSA) is providing grantees additional 
options for making waiver requests.
    HRSA is amending the uniform waiver standards for RWP grantees 
requesting a core medical services waiver for fiscal year (FY) 2014 and 
beyond. The amended standards will allow grantees to apply for a waiver 
(a) at the same time as their annual Part A, B, or C application 
submission, (b) at any time up to their annual Part A, B, or C 
application submission, or (c) up to four months after their grant 
award for that funding year. This Federal Register notice seeks to make 
public the revised policy and provide an opportunity for public comment 
before its implementation.

DATES: Comments on this final policy must be received by June 24, 2013. 
The policy will become effective on September 23, 2013.

ADDRESSES: Written comments should be sent via email to the Division of 
Policy and Data, HIV/AIDS Bureau, Health Resources and Services 
Administration at [email protected] by June 24, 2013.

FOR FURTHER INFORMATION CONTACT: Theresa Jumento using the email above 
or by telephone at (301) 443-5807.

SUPPLEMENTARY INFORMATION: In response to the requests from the grantee 
community, and in order for grantees to plan appropriately, HRSA is 
revising the requirement that core medical services waiver requests be 
submitted with an applicant's grant application for the upcoming fiscal 
year. Under this revision, grantees may submit core medical services 
waiver requests prior to the annual grant application, with the 
application, or up to four months after the grant award date. HRSA 
believes that this change will allow grantees to more robustly assess 
and develop their funding and service delivery proposal. In addition, 
if the waiver request has already been received and approved, the 
application can be based on the approved waiver, and therefore include 
allocation tables based on that approval. Further, HRSA is clarifying 
that grantees approved for a core medical services waiver are not 
compelled to implement that waiver should the grantee determine that 
the actual needs of the jurisdiction are best met by maintaining 
funding for core medical services.
    This revision replaces policy notice 08-02 and more 
clearly outlines the requirements to request a waiver of the core 
medical services provision. In response to concerns expressed by 
grantees, it provides additional clarity with regard to specific 
documentation expectations for each element of the waiver. It specifies 
clearly those documentation expectations whether the waiver request is 
submitted separately or jointly with the annual funding application.
    For waiver applicants that do not submit their request with their 
annual grant application, HRSA is now requiring that these applicants 
submit a tentative allocation table outlining the percentage of funds 
that the grantee plans to spend on core medical and support services 
under the waiver, if approved. This will provide additional information 
to HRSA on how the grantee anticipates allocating its resources and 
will help to demonstrate that the request for a waiver is consistent 
with either the applicant's forthcoming grant application or their 
proposed budget revision. In addition to the applicant's annual grant 
application, waiver applicants now must also demonstrate that the 
proposed waiver is also consistent with the Comprehensive Plan and 
Statewide Coordinated Statement of Need.
    The revised policy removes the section entitled ``Types of 
Documentation and Evidence.'' Instead, the requirements for the waiver 
are listed and then the policy specifies the documentation necessary to 
establish compliance. These changes clarify the documentation that 
grantees must use to meet each core medical services waiver request 
requirement. By standardizing the documentation for all grantees, HRSA 
will gain a clearer understanding of the availability of core medical 
services in the applicant's jurisdiction. Furthermore, HRSA will be 
able to make a more informed decision about the appropriateness of 
waiving the core medical services requirement in a jurisdiction.
    In addition, the standardization of the documentation will ensure 
that HRSA has sufficient information to make an informed decision on 
each waiver request. Finally, the revised policy imposes a page number 
limitation on the narrative section of the core medical services waiver 
request. In addition, applicants will now submit core medical services 
waiver requests through the Electronic Handbook (EHB) Prior Approval 
portal when the core medical services waiver application is not being 
submitted with an annual grant application.
    These revisions are intended to clarify the waiver process, and 
respond to the changing needs of the grantee community, while at the 
same time ensuring that the waiver process is fair and sufficiently 
robust so that HRSA undertakes appropriate reviews.

Policy

Uniform Standard for Waiver of Core Medical Services Requirement for 
Grantees Under Parts, A, B, and C

    POLICY NUMBER 13-xx (Replaces Policy Notice 08-02).

Scope of Policy

    Ryan White Parts A, B, C.

Summary and Purpose of Policy

    The purpose of this policy is to outline the Health Resources and 
Services Administration (HRSA) HIV/AIDS Bureau (HAB) requirements for 
applying for a waiver of the requirement that 75 percent of Ryan White 
HIV/AIDS program funds be spent on core medical services.

Background

    Title XXVI of the Public Health Service Act, Part A section 
2604(c), Part B section 2612(b), and Part C section 2651(c) requires 
that grantees expend not less than 75 percent of their grant funds on 
core medical services. These sections also grant the Secretary 
authority to waive this requirement if there are no waiting lists for 
the AIDS Drug Assistance Program (ADAP) and core medical services are 
available to all individuals identified and eligible under Title XXVI 
in an applicant's service area.

Policy

    Grantees may submit a waiver request at any time prior to 
submission of the annual grant application, along with the annual grant 
application, or up to 4 months after the start of the grant year for 
which a waiver is being requested. Applications submitted before or 
after an annual grant application have different requirements than 
those submitted with an annual grant application. Applicants should 
choose the method that best meets their needs. The requirements for 
each process are outlined below.

Requirements To Apply for a Waiver Before or After an Annual Grant 
Application

    This section outlines the requirements to submit a waiver 
application: (1) in advance of a grantee's annual grant application or 
(2) after the grant application has been submitted up to 4 months into 
the grant year for which a waiver is being requested. Waiver requests 
must be submitted through the

[[Page 31565]]

EHB Prior Approval portal and must identify the grant year for which 
the waiver is being requested. The waiver request must be signed by the 
chief elected official or the Project Director, and include the 
following documentation that will be utilized by HRSA in determining 
whether to grant the waiver:
    1. Letter signed by the Director of the Part B State/Territory 
Grantee indicating that there is no current or anticipated ADAP 
services waiting list in the State/Territory.
    2. Evidence that all core medical services listed in the statute 
(Part A section 2604(c)(3), Part B section 2612(b)(3), and Part C 
section 2651(c)(3)), regardless of whether such services are funded by 
the Ryan White HIV/AIDS Program, are available and accessible within 30 
days for all identified and eligible individuals with HIV/AIDS in the 
service area, without need to expend at least 75 percent of Ryan White 
funds on these services. Acceptable evidence must include all of the 
following:
    a. HIV/AIDS care and treatment services inventories, including 
identification of the specific core medical services available, from 
whom, and through what funding source;
    b. HIV/AIDS client/patient service utilization data in addition to 
what has previously been submitted via the Ryan White Services Report 
(RSR); and
    c. Letters from Medicaid and other State and local HIV/AIDS 
entitlement and benefits programs, which may include private insurers.
    3. Evidence of a public process, which documents that the applicant 
has sought input from affected communities; including consumers and the 
Ryan White HIV/AIDS Program-funded core medical services providers, 
related to the availability of core medical services and the decision 
to request a waiver. This public process may be the same one that is 
utilized for obtaining input on community needs as part of the annual 
priority setting and resource allocation, comprehensive planning, 
Statewide Coordinated Statement of Need (SCSN), public planning, and/or 
needs assessment process. Acceptable evidence must, at a minimum, 
include:
    a. Letters from both the Planning Council Chair in the Metropolitan 
area (if grantee serves such area) and the State HIV/AIDS Director 
describing the public process that occurred in each jurisdiction.
    4. A narrative of up to, but no more than, 10 pages that explains 
each item in a. through d. below:
    a. Any underlying State or local issues that influenced the 
grantee's decision to request a waiver.
    b. How the documentation submitted under item two supports the 
assertion that such core services are available and accessible to all 
individuals with HIV/AIDS, identified and eligible under Title XXVI in 
the service area.
    c. How the approval of a waiver will positively contribute to the 
grantee's ability to address service needs for HIV/AIDS non-core 
services. Specifically address the grantee's ability to perform 
outreach and linkage of HIV-positive individuals not currently in care.
    d. How the receipt of the core medical services waiver will allow 
for implementation consistent with the applicant's proposed percentage 
allocation of resources, comprehensive plan, and SCSN. Applicants must 
also document consistency by providing a proposed allocation table.

Waiver Review and Notification Process

    HRSA/HAB will review the request and notify grantees of waiver 
approval or denial within eight weeks of receipt of the request. Core 
medical services waivers will be effective for the grant award period 
for which it is approved. Subsequent grant periods will require a new 
waiver request. Grantees that are approved for a core medical services 
waiver in advance of their annual grant application are not compelled 
to utilize the waiver should circumstances change.

Requirements To Apply for a Waiver With the Annual Grant Application

    This section provides guidance for grantees who wish to submit a 
waiver request with their annual grant application. Waiver requests 
must be submitted as an attachment to the grantee's annual grant 
application and should not be submitted through the EHB Prior Approval 
portal. The waiver request must be signed by the chief elected official 
or the Project Director, and include the following documentation that 
will be utilized by HRSA in determining whether to grant the waiver:
    1. Letter signed by the Director of the Part B State/Territory 
Grantee indicating that there is no current or anticipated ADAP 
services waiting list in the State/Territory.
    2. Evidence that all core medical services listed in the statute 
(Part A section 2604(c)(3), Part B section 2612(b)(3), and Part C 
section 2651(c)(3)), regardless of whether such services are funded by 
the Ryan White HIV/AIDS Program, are available and accessible within 30 
days for all identified and eligible individuals with HIV/AIDS in the 
service area, without need to expend at least 75 percent of Ryan White 
funds on these services. Acceptable evidence must include all of the 
following:
    a. HIV/AIDS care and treatment services inventories, including 
identification of the specific core medical services available, from 
whom, and through what funding source;
    b. HIV/AIDS client/patient service utilization data in addition to 
what has previously been submitted via the Ryan White Services Report 
(RSR); and
    c. Letters from Medicaid and other State and local HIV/AIDS 
entitlement and benefits programs, which may include private insurers.
    3. Evidence of a public process, which documents that the applicant 
has sought input from affected communities; including consumers and the 
Ryan White HIV/AIDS Program-funded core medical services providers, 
related to the availability of core medical services and the decision 
to request a waiver. This public process may be the same one that is 
utilized for obtaining input on community needs as part of the annual 
priority setting and resource allocation, comprehensive planning, 
Statewide Coordinated Statement of Need (SCSN), public planning, and/or 
needs assessment process. Acceptable evidence must, at a minimum, 
include:
    a. Letters from both the Planning Council Chair in the Metropolitan 
area (if grantee serves such area) and the State HIV/AIDS Director 
describing the public process that occurred in each jurisdiction.
    4. A narrative of up to, but no more than, 10 pages that explains 
each item in a. through d. below:
    a. Any underlying State or local issues that influenced the 
grantee's decision to request a waiver.
    b. How the documentation submitted under item two supports the 
assertion that such core services are available and accessible to all 
individuals with HIV/AIDS, identified and eligible under Title XXVI in 
the service area.
    c. How the approval of a waiver will positively contribute to the 
grantee's ability to address service needs for HIV/AIDS non-core 
services. Specifically address the grantee's ability to perform 
outreach and linkage of HIV-positive individuals not currently in care.
    d. How the receipt of the core medical services waiver is 
consistent with the applicant's grant application, comprehensive plan, 
and SCSN. Applicants must also document consistency by providing the 
following:

[[Page 31566]]

    i. Proposed allocation table, if not included as part of the grant 
application and
    ii. (PART A) ``Description of Priority Setting and Resource 
Allocation Processes'' and ``Unmet Need Estimate and Assessment'' 
sections of the current grant application; or
    iii. (PART B) ``Needs Assessment and Unmet Need'' section of the 
current grant application; or
    iv. (PART C) ``Description of the Local HIV Service Delivery 
System'' and ``Current and Projected Sources of Funding'' sections of 
the current grant application.

Waiver Review and Notification Process

    HRSA/HAB will review the request and notify grantees of waiver 
approval or denial no later than the date of issuance of the Notice of 
Award (NoA). Core medical services waivers will be effective for the 
grant award period for which it is approved. Subsequent grant periods 
will require a new waiver request. Grantees that are approved for a 
core medical services waiver in their annual grant application are not 
compelled to utilize the waiver should circumstances change.

The Paperwork Reduction Act of 1995

    This activity has been reviewed and approved by the Office of 
Management and Budget, under the Paperwork Reduction Act of 1995 
(Control number 0915-0307).

    Dated: May 17, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013-12354 Filed 5-23-13; 8:45 am]
BILLING CODE 4165-15-P