[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]
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