[Federal Register Volume 72, Number 227 (Tuesday, November 27, 2007)]
[Notices]
[Pages 66181-66182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22982]


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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 (HRSA), HHS.

ACTION: Notice of opportunity to provide written comments.

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SUMMARY: This notice solicits comments on the HRSA proposed uniform 
waiver standards for Ryan White HIV/AIDS Program grantees requesting a 
core medical services waiver for Fiscal Year 2008 and beyond. Title 
XXVI of the Public Health Service Act (PHS) Act, as amended by the Ryan 
White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS 
Program) 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 
legislation, effective Fiscal Year (FY) 2007. HRSA has issued guidance 
for obtaining a waiver for FY 2007 and seeks to issue waiver 
requirements for grantees under Parts A, B, and C of Title XXVI of the 
PHS Act for FY 2008 and future years.

DATES: Written comments must be received no later than 30 days after 
date of publication in the Federal Register.

ADDRESSES: Written comments should be sent to HRSA, HAB, Division of 
Science and Policy, Attention: LCDR Gettie A. Butts, 5600 Fishers Lane, 
Room 7-18, Rockville, Maryland 20857.

FOR FURTHER INFORMATION CONTACT: LCDR Gettie A. Butts, at: 
[email protected] or by writing to the address above.

SUPPLEMENTARY INFORMATION: The statute, Title XXVI of the Public Health 
Service Act (PHS) Act, as amended by the Ryan White HIV/AIDS Treatment 
Modernization Act of 2006, imposes two criteria for waiver eligibility: 
(1) No waiting lists for AIDS Drug Assistance Program (ADAP) services; 
and (2) core medical services availability within the relevant service 
area to all individuals with HIV/AIDS identified and eligible under 
Title XXVI of the PHS Act. See sections 2604(c)(2), 2612(b)(2), and 
2651(c)(2) of the PHS Act. The Health Resources and Services 
Administration (HRSA) HIV/AIDS Bureau has issued interim waiver 
eligibility guidance for FY 2007 to provide immediate implementation of 
these waiver provisions. The FY 2007 guidance

[[Page 66182]]

required that grantees provide written certification stating that all 
Ryan White-funded core medical services are available in the service 
area and that no ADAP waiting list exists. Given the need for immediate 
implementation, the guidance offered an expeditious process by which 
grantees could apply for a waiver for FY 2007. HRSA now provides notice 
of its proposal for a more permanent process by which such waivers will 
be granted beginning in FY 2008 and seeks public comment on its 
proposal.
    Beginning in FY 2008, HRSA will utilize new standards for granting 
waivers of the core medical services requirement for Ryan White HIV/
AIDS Programs. These standards meet the intent of the Ryan White HIV/
AIDS Treatment Modernization Act of 2006 to increase access to core 
medical services, including antiretroviral drugs, for persons with HIV/
AIDS and to ensure that grantees receiving waivers demonstrate the 
availability of such services for individuals with HIV/AIDS identified 
and eligible under Title XXVI of the PHS Act. The purposes of this 
notice are: (1) To establish requirements for core medical services 
waiver eligibility for grantees under Parts A, B, and C of Title XXVI 
of the PHS Act; and (2) to establish a process for waiver request 
submission, review and notification. The core medical services waiver 
uniform standard and waiver request process proposed in this notice 
will apply to Ryan White HIV/AIDS Program grant awards under Parts A, 
B, and C of Title XXVI of the PHS Act.

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

    Grantees must submit a waiver request with the annual grant 
application containing the following certifications and documentation 
which will be utilized by HRSA in determining whether to grant a 
waiver. The waiver must be signed by the chief elected official or the 
fiscally responsible agent, and include:
    1. Certification from the Part B state grantee that there are no 
current or anticipated ADAP services waiting lists in the state for the 
year in which such waiver request is made. This certification must also 
specify that there are no waiting lists for a particular core class of 
antiretroviral therapeutics established by the Secretary, e.g., fusion 
inhibitors;
    2. Certification 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 within 30 days for 
all identified and eligible individuals with HIV/AIDS in the service 
area;
    3. Evidence that a public process was conducted to seek public 
input on availability of core medical services;
    4. Evidence that receipt of the core medical services waiver is 
consistent with the grantee's Ryan White HIV/AIDS Program application 
(e.g., ``Description of Priority Setting and Resource Allocation 
Processes'' and ``Unmet Need Estimate and Assessment'' sections of the 
application for Parts A, ``Needs Assessment and Unmet Need'' section of 
the application under Part B, and ``Description of the Local HIV 
Service Delivery System,'' and ``Current and Projected Sources of 
Funding'' sections of the application under Part C).

Types of Documentation and Evidence

    Grantees must provide evidence that all of the core medical 
services listed in the statute, regardless of whether such services are 
funded by the Ryan White HIV/AIDS Program, are available to all 
individuals with HIV/AIDS identified and eligible under Title XXVI of 
the PHS Act in the service area within 30 days. Such documentation may 
include one or more of the following types of information for the 
service area for the prior fiscal year: HIV/AIDS care and treatment 
services inventories including funding sources, HIV/AIDS met and unmet 
need assessments, HIV/AIDS client/patient service utilization data, 
planning council core medical services priority setting and funding 
allocations documents, and letters from Medicaid and other state and 
local HIV/AIDS entitlement and benefits programs including private 
insurers. Information provided by grantees must show specific 
verifiable evidence that all listed core medical services are available 
and are being utilized to meet the needs of persons with HIV/AIDS who 
are identified and eligible for Ryan White HIV/AIDS Program services 
without further infusion of Ryan White HIV/AIDS Program dollars. Such 
documentation must also describe which specific core medical services 
are available, from whom, and through what funding source.
    Grantees must have evidence of a public process for the 
dissemination of information and must seek input from affected 
communities related to the availability of core medical services and 
the decision to request a waiver. This public process may be the same 
one utilized for obtaining input on community needs as part of the 
comprehensive planning process. In addition, grantees must describe in 
narrative form the following:
    1. Local/state underlying issues that influenced the grantee's 
decision to request a waiver and how the submitted documentation 
supports the assertion that such services are available and accessible 
to all individuals with HIV/AIDS identified and eligible under Title 
XXVI in the service area.
    2. How the approval of a waiver will impact the grantee's ability 
to address unmet need for HIV/AIDS services and perform outreach to 
HIV-positive individuals not currently in care.
    3. The consistency of the waiver request with the grantee's grant 
application, including proposed service priorities and funding 
allocations.

Waiver Review and Notification Process

    As indicated, grantees must submit a waiver request with their 
annual grant application. No waiver requests will be accepted at any 
other time (other than with the annual grant application). Application 
guidance documents will be amended to include this requirement. HRSA/
HAB will review requests for waiver of the core medical services 
requirement and will notify grantees of waiver approval no later than 
the date of issuance of Notice of Grant Award. Core medical services 
waivers will be effective for a one-year period consistent with the 
grant award period.

The Paperwork Reduction Act of 1995

    This activity is subject to Office of Management and Budget review 
and approval under the Paperwork Reduction Act of 1995.

    Dated: November 16, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7-22982 Filed 11-26-07; 8:45 am]
BILLING CODE 4165-15-P