Policy
Notice - Notice 07-02
TO:
All Ryan White HIV/AIDS Program Grantees
Attached is the HIV/AIDS Bureau (HAB) updated
policy describing the use of Ryan White
HIV/AIDS Program funds for HIV diagnostics
and laboratory tests. This policy was previously
published as "Policy Notice 99-03."
This updated policy reflects the changes
in Title XXVI of the Public Health Service
Act as amended by the Ryan White HIV/AIDS
Treatment Modernization Act of 2006 (Ryan
White HIV/AIDS Program) and establishes
updated guidelines for the use of Ryan White
HIV/AIDS Program funds for HIV diagnostics
and laboratory tests for Parts A through
D of the Ryan White HIV/AIDS Program.
This policy is consistent with the "Public
Health Service Guidelines for the Use of
Antiretroviral Agents in HIV-1-Infected
Adults and Adolescents", "Public
Health Service Guidelines for the Use of
Antiretroviral Agents in Pediatric HIV Infection",
"Revised Recommendations for HIV Testing
of Adults, Adolescents, and Pregnant Women
in Health-Care Settings", and other
standards, supported by professional associations.
The attached policy emphasizes the importance
of diagnostics and laboratory tests as clinical
tools in medical assessment and treatment
decision-making, related to HIV/AIDS antiretroviral
agents and other medications that treat
HIV/AIDS or opportunistic infections related
to HIV disease.
If you have any questions regarding the
content of the HAB Policy Notice, please
contact your project officer. Thank you
for your attention to this important matter.
Deborah Parham Hopson, Ph.D., R.N.
Assistant Surgeon General
Associate Administrator
Attachment
Policy Notice 07-02: The Use of Ryan White
HIV/AIDS Program Funds for HIV Diagnostics
and Laboratory Tests Policy
The purpose of all Ryan White HIV/AIDS Program
funds is to ensure that eligible HIV-infected
persons and families gain and/or maintain
access to medical care. In accordance with
the provisions of Title XXVI of the Public
Health Service Act, as amended by the Ryan
White HIV/AIDS Treatment Modernization Act
of 2006 (Ryan White HIV/AIDS Program), the
following policy establishes guidelines
for the use of Ryan White HIV/AIDS Program
funds for HIV diagnostics and laboratory
tests.
I.
Ryan White HIV/AIDS Program funds for Parts
A, B (including ADAP funds), C, and D may
be used by grantees for support of diagnostic
and laboratory tests integral to the treatment
of HIV infection and related complications
(for example, but not limited to, CD4 counts,
viral load tests, genotype assays) under
the following conditions:
- The
tests are consistent with medical and
laboratory standards, as established by
scientific evidence and supported by professional
panels, associations, or organizations.
Types of standards include, but are not
limited to:
- Public Health Service Guidelines for
the Use of Antiretroviral Agents in HIV-1-Infected
Adults and Adolescents";
- Public Health Service Guidelines for
the Use of Antiretroviral Agents in Pediatric
HIV Infection";
- Revised Recommendations for HIV Testing
of Adults, Adolescents, and Pregnant Women
in Health-Care Settings", and
- Other standards supported by professional
associations, such as the Infectious Diseases
Society of America, American Medical Association,
American Pediatric Association, and American
College of Obstetricians and Gynecologists.
- Such
diagnostics and laboratory tests (1) are
approved by the Food and Drug Administration
(FDA), when required under the FDA Medical
Devices Act and/or (2) are performed in
an approved Clinical Laboratory Improvement
Amendments of 1988 (CLIA) certified laboratory
or State-exempt laboratory.
- Such
diagnostics and laboratory tests (1) are
ordered by a registered, certified, or
licensed medical provider and (2) are
necessary and appropriate, based on established
clinical practice standards (refer to
Section 1) and professional clinical judgment.
- Ryan
White HIV/AIDS Program funds are the payer
of last resort by statute; therefore,
grantees must demonstrate a procedural
mechanism for purposes of identification
and billing of liable payers. Funds for
diagnostics and laboratory tests cannot
be expended without such a procedure in
place.
Diagnostic and laboratory tests, ordered
in accordance with this policy, constitute
core medical services, as that term is
defined in Parts A, B, and C of the PHS
Act.
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