[Federal Register Volume 73, Number 113 (Wednesday, June 11, 2008)]
[Notices]
[Pages 33097-33099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13102]
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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: The Health Resources and Services Administration (HRSA) is
amending the uniform waiver standards for Ryan White HIV/AIDS Program
grantees requesting a core medical services waiver for fiscal year (FY)
2009 and beyond. Title XXVI of the Public Health Service (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. HRSA has issued waiver standards for
grantees under Parts A, B, and C of Title XXVI of the PHS Act. This
Federal Register notice seeks to make public the final notice of
Uniform Standard for Waiver of Core Medical Services Requirements for
Grantees Under Parts A, B, and C effective FY 2009.
SUPPLEMENTARY INFORMATION: The Ryan White HIV/AIDS Program 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.) HRSA's
HIV/AIDS Bureau issued interim waiver eligibility guidance for FY 2007
to provide immediate implementation of these waiver provisions. The
final Uniform Standard for Waiver of Core Medical Services Requirements
for Grantees Under Parts A, B, and C reflects modifications based on
public comment received in response to the guidance published in the
Federal Register on November 27, 2007. During the 30-day comment period
ending December 26, 2007, HAB received comments from the public.
Beginning in FY 2009, HRSA will utilize new standards for granting
waivers of the core medical services requirement for Ryan White HIV/
AIDS Program grantees. 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 a uniform standard 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 in this
notice apply to Ryan White HIV/AIDS Program grant awards under Parts A,
B, and C of Title XXVI of the PHS Act effective for the FY 2009 grant
year.
Comments on the Proposed Uniform Standard for Waiver of Core Medical
Services Requirements for Grantees Under Parts A, B, and C
There were several public comments in strong support of the draft
policy stating that the proposed changes allow more funds to be
allocated to life-saving core medical services, including medications.
The following suggestions and concerns were the main issues raised in
the public comments.
Issue (1): Types of Documentation and Evidence Required as Part of the
Waiver Request.
(Comment) Submission of documentation letters from private payers
should be optional, not required.
(Response) HRSA concurs with the suggestion and changed the
sentence regarding private insurers to ``letters from Medicaid and
other State and local HIV/AIDS entitlement and benefits programs, which
may include private insurers''.
[[Page 33098]]
(Comment) Requiring submission of data demonstrating that services
are ``being utilized'' is unreasonable and falls outside the provisions
of the statute.
(Response) HRSA concurs with the comment. As amended, the standard
requires grantees to provide specific verifiable evidence that all
listed core medical services are available and accessible 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.
(Comment) ``Verifiable evidence'' that core services are available
and accessible is not replicable across jurisdictions and would not
result in ``uniform waiver standards''.
(Response) HRSA does not concur with the comment. The core medical
services waiver standards do not require that methods of providing
``verifiable evidence'' of service availability and accessibility be
replicable across jurisdictions. When submitting a waiver request, each
jurisdiction must submit clear and concise verifiable documentation as
to the availability and accessibility of all core medical services in
their service area. Each waiver request will be reviewed and assessed
individually on its merits.
(Comment) There is no basis for the proposed standard that all core
medical services must be available within 30 days.
(Response) The Ryan White HIV/AIDS Program legislation specifies
that core medical services must be ``available.'' 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 (HHS/CMS). (See Medicare
Managed Care Manual, Chapter 4 Benefits and Beneficiary Protections,
section 120.2 Access and Availability Rules for Coordinated Care Plans
at http://www.cms.hhs.gov/manuals/downloads/mc86c04.pdf.) 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.
Issue (2): Core Medical Services Waiver Requests Submitted as Part of
the Annual Grant Application
(Comment) Core medical services waiver requests should be allowed
to be submitted after awards are received, to better respond to
fluctuations in funding.
(Response) HRSA does not agree with the recommendation to submit
waiver requests after receipt of a Notice of Grant Awards (NGA). By
law, the waiver will be granted at the time the award is made (See
sections 2604(c)(2)(B), 2612(b)(2)(B), and 2651(c)(2)(B) of the PHS
Act.)
Issue (3): Requests for Obtaining a Core Medical Services Waiver Need
to be Strengthened to Require More Stringent Documentation Than That
Proposed
(Comment) Requests for obtaining a core medical service waiver
should include assurances that core services are available and
accessible to those most in need. Documentation should include
information about average waiting times for first appointments, average
travel time to service locations as well as cost-sharing or service
limits related to core services. Grantees should be required to
identify all eligible people including those not yet diagnosed.
(Response) HRSA acknowledges the commenter's emphasis on the
importance of access to services and follow-up, however, disagrees with
the suggestion for additional documentation as this would be overly
burdensome to grantees seeking core medical service waivers.
Furthermore, the documentation imposed by this final notice is
sufficiently detailed for HRSA to approve or deny core medical services
waiver requests.
(Comment) Require that Ryan White HIV/AIDS Program-funded core
medical services providers be included in the public process.
(Response) HRSA concurs. Grantees will be required to provide
evidence of a public process for the dissemination of information and
must document that they have sought input from affected communities,
including Ryan White HIV/AIDS Program-funded core medical services
providers.
(Comment) Public input should be independent of routine community
planning.
(Response) HRSA does not concur. Requiring a public input process
independent of routine community planning would be burdensome given
Ryan White HIV/AIDS Program administrative cost caps.
(Comment) Require documentation demonstrating that grantees
applying for waivers have made reasonable efforts to identify all
eligible persons including those not yet diagnosed and link them to
care. This should include using at least 25 percent of Ryan White HIV/
AIDS Program funding on outreach and testing.
(Response) HRSA agrees with the commenter's emphasis on the
importance of ensuring that all cases of HIV and AIDS are identified
and brought into care, but disagrees with the proposal. HRSA urges all
of the Ryan White HIV/AIDS Program grantees to utilize available
outreach funding, including those available from the Centers for
Disease Control and Prevention, to identify HIV-positive individuals
and provide linkages to HIV care and treatment.
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).
[[Page 33099]]
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, which may include
private insurers. Information provided by grantees must show specific
verifiable evidence that all listed core medical services are available
and accessible 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 document that they have sought
input from affected communities, including 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 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 a NOGA. Core medical services waivers will be
effective for a one-year period consistent with the grant award period.
The Paperwork Reduction Act of 1995
The burden for this activity has been reviewed and approved by the
Office of Management and Budget under the Paperwork Reduction Act of
1995 (OMB Number 0915-0307).
Dated: June 5, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8-13102 Filed 6-10-08; 8:45 am]
BILLING CODE 4165-15-P