[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Notices]
[Pages 63990-63993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-25276]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


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

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Final notice.

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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 RWHAP), 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 
state, jurisdiction, or service area, as applicable.
    The requirements for submitting an application to waive the 
statutory requirement that a grantee spend at least 75 percent of its 
funds on core medical were previously outlined in HIV/AIDS Bureau (HAB) 
Policy Notice 08-02. On May 24, 2013, the Health Resources and Services 
Administration (HRSA) published a Final Notice with Opportunity to 
Comment in the Federal Register, revising HAB Policy Notice 08-02, and 
requesting public comment on this revised policy. This Federal Register 
notice seeks to address comments made by the public and to implement 
this policy as originally written.

DATES: The policy will become effective on September 23, 2013.

SUPPLEMENTARY INFORMATION: HRSA received several comments on the waiver 
application process published in the Federal Register. Overall, the 
comments were supportive of the revised requirements. Commenters 
indicated that the revised application process will provide grantees 
with the flexibility to adjust resource allocation based on the current 
situation in their local environment.
    Several commenters suggested that the application process and the 
documentation required to apply for a waiver was burdensome, especially 
for grantees with limited administrative staff to respond to the waiver 
requirements. HRSA believes that the application process and the 
documentation required are necessary for the agency to understand the 
availability of core medical services in the applicant's state, 
jurisdiction, or service area, as applicable. This required 
documentation is intended to provide HRSA with sufficient information 
to make an informed decision on each waiver request and to understand 
the availability of core medical services in a grantee's state, 
jurisdiction, or service area, as applicable. Further, the requirements 
are similar to those under the previous policy. Waiver applicants under 
the previous policy were expected to provide adequate documentation, 
which may have included additional data, supporting letters, and other 
information that justified the need for the waiver. As such, HRSA is 
only clarifying what documentation is necessary to meet each 
requirement in the application. This will ensure that the applicant 
provides adequate documentation to demonstrate the need for a waiver of 
the core medical services requirement
    Under the previous policy, letters from Medicaid directors and 
other State and local HIV/AIDS entitlement and benefits programs, which 
may include private insurers, were optional. Under this revision, item 
2(c) of the policy now requires the submission of 
documentation regarding the availability of relevant services, and 
lists examples of the types of programs that may provide documentation, 
including private insurers. Specific to this requirement, several 
commenters suggested that letters from private insurers would be 
burdensome to provide. HRSA wishes to clarify that letters from private 
insurers are not required; these entities are only listed to provide an 
example of a type of entitlement and benefit provider. Other types of 
entitlement and benefit providers might include local foundations that 
provide funding for medical care to low-income HIV patients or a county 
or state sponsored drug-assistance program. As part of their 
application, grantees must provide letters from the state Medicaid 
Director and relevant HIV/AIDS entitlement and benefits programs 
available in their state, jurisdiction, or service area, as

[[Page 63991]]

applicable, to document the availability and accessibility of core 
medical services.
    Several commenters pointed out that it would be burdensome for 
grantees to conduct a separate public process around the annual waiver 
application. HRSA wishes to clarify that while a grantee may conduct a 
separate public process around the waiver application, they are not 
required to do so. Grantees must seek feedback on their waiver 
application from the public, but may do so through any public process 
that the grantee already uses, including those that are used to obtain 
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 process. 
This requirement has not changed from the previous policy.
    Another commenter requested that HRSA not include the waiver 
attachments and documentation requirements as part of the application's 
10-page limit listed in requirement 4. HRSA wishes to clarify 
that the page limit only applies to the narrative section described in 
requirement 4. The documentation required by the other 
sections does not count towards the page limit outlined in the policy.
    Another commenter mentioned concern regarding ``outreach and 
linkage of HIV-positive individuals not currently in care'' being 
considered a non-core service in the requirement 4(c) of the 
policy. The commenter indicated that outreach and linkage to care fell 
under early intervention services, and as such should not be considered 
a non-core service. HRSA wishes to clarify that section 4(c) 
of the policy is specifically referring to outreach and linkage to care 
as a support service, not early intervention services, which, as the 
commenter mentioned, are core medical services. In 42 U.S.C. 300ff-
14(d)(1), 300ff-22(c)(1), 300ff-51(d)(1), outreach services are 
identified as support services. In addition, HAB policy 12-01 
identifies outreach services as a service ``which has as their 
principal purpose targeting activities, under specific needs 
assessment-based service categories that can identify individuals with 
HIV disease. This includes those who know their HIV status and are not 
in care as well as those individuals who are unaware of their HIV 
status, so that they become aware of the availability of HIV-related 
services and enroll in primary care, AIDS Drug Assistance Programs, and 
support services that enable them to remain in care.''
    Another commenter suggested that the requirement that all core 
services be available within 30 days is not reasonable. Access to 
routine medical and preventive care services within 30 days has been 
cited as an example of a reasonable availability standard for Medicare 
Coordinated Care Plans by the Department of Health and Human Services/
Centers for Medicare and Medicaid Services (See Medicare Managed Care 
Manual, Chapter 4 Benefits and Beneficiary Protections, section 110.1 
Access and Availability Rules for Coordinated Care Plans at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/mc86c04.pdf.). In addition, the RWHAP legislation specifies that core 
medical services must be ``available.'' This requirement has not 
changed from previous versions of this policy. Therefore, HRSA will 
maintain the requirement that all core medical services are available 
to individuals identified in the service area within 30 days, as this 
requirement serves as a benchmark for the availability of core medical 
services.
    Other commenters suggested that the application acceptance 
timeframe be changed to a rolling basis, rather than requiring that 
waiver applications be submitted before, during, or after application 
deadlines, or that waiver applications be preapproved, with complete 
documentation submitted only when the grantee invokes the waiver. While 
HRSA agrees that these methods may be more straightforward, the current 
process and timelines used to manage and monitor grant applications 
makes either of these processes not feasible for HRSA.
    This Final Notice reaffirms HRSA's position that these revisions to 
HAB Policy Notice 08-02 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 is able to undertake appropriate review. The policy 
will remain in effect, as originally published, and will be identified 
as HAB Policy Notice 13-07.

Policy

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

    POLICY NUMBER 13-07 (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 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

[[Page 63992]]

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:
    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.

[[Page 63993]]

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: October 18, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013-25276 Filed 10-24-13; 8:45 am]
BILLING CODE 4165-15-P