Policy
Notice - 07- 03
September
2007
TO:
All Ryan White HIV/AIDS Program Grantees
Attached
is the HIV/AIDS Bureau's (HAB) updated policy
describing the use of Ryan White HIV/AIDS
Program Part B funds for access, adherence,
and monitoring services.This policy was
previously published as "Policy Notice 00-02"
and was amended April 26, 2001.This updated
policy reflects the technical 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 Part B Funds for Access,
Adherence and Monitoring Services affecting
the AIDS Drug Assistance Program (ADAP).In
essence, the previous policy has not undergone
any substantive changes and is being re-issued
to reflect the technical changes as a result
of the newly reauthorized Ryan White HIV/AIDS
Program, including a reference to the provision
requiring States to have certain classes
of core antiretroviral medications on their
formularies.
On
July 26, 2000, the HIV/AIDS Bureau (HAB)
issued a policy clarifying how Ryan White
HIV/AIDS Program funds from the ADAP appropriation
could be used to provide services to increase
access to medications, adherence to medication
regimens, and monitoring of progress to
therapy. Specifically, the Ryan White HIV/AIDS
Program Section 2616(c)(6) of the Public
Health Service Act contains language that
permits ADAP funds to be used to "encourage,
support, and enhance adherence to and compliance
with treatment regimens, including related
medical monitoring." However, the law
places some limits on the use of ADAP funds
for these purposes. It states, "Of
the amount reserved by a State for a fiscal
year for use under this section, the State
may not use more than 5 percent to carry
out services under [this] paragraph, except
that the percentage applicable with respect
to such paragraph is 10 percent if the State
demonstrates to the Secretary that such
additional services are essential and in
no way diminish access to the therapeutics
described in subsection 2616(a)."
HAB
interprets this provision to say that the
criteria for using ADAP funds for services
related to access, adherence, and monitoring
are still appropriate and in force, and
that no more than 5 percent of a State's
ADAP funding in a given year may be used
for these services unless there are extraordinary
circumstances that would warrant up to10
percent of a State's ADAP funding being
used. We have included some examples of
extraordinary circumstances.
If
you have any questions regarding the content
of this HAB Policy Notice, please contact
your project officer. Thank you for your
attention in this important matter.
Deborah
Parham Hopson, Ph.D., R.N.
Assistant
Surgeon General
Associate Administrator
Attachment
The
Use of Ryan White HIV/AIDS Program, Part B,
AIDS Drug Assistance Program (ADAP) Funds
for Access, Adherence, and Monitoring Services
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 updated guidelines for the use
of Ryan White HIV/AIDS Program funds for allowable
ADAP-related expenditures.The purpose of all
Ryan White HIV/AIDS Program ADAP funds is
to ensure that eligible HIV-infected persons
gain or maintain access to HIV-related medications.This
policy continues to provide grantees greater
flexibility in the use of ADAP funds and permits
expenditures of ADAP funds for services that
improve access to medications, increase adherence
to medication regiments, and help clients
monitor their progress in taking HIV-related
medications.This policy further clarifies
the use of ADAP funds under Section I, item
A specified below.
I.
Federal funds received under the Ryan White
HIV/AIDS Program, ADAP, as established by
Section 2612(b)(3)(B) of the Public Health
Service (PHS) Act, in accordance with Section
2616 of the PHS Act, may be used for access,
adherence, and monitoring services under
the following conditions.
A.
No more than 5 percent of ADAP funds may
be used for the following services, except
that under extraordinary circumstances,
no more than 10 percent of ADAP funds may
be used to fund:(1) enabling eligible individuals
to gain access to drugs; (2) supporting
adherence to the drug regiment necessary
to experience the full health benefits afforded
by the medications; and (3) services to
monitor the client's progress in taking
HIV-related medications (refer to HAB Policy
Notice 07-02, "The Use of Ryan White HIV/AIDS
Program Funds for HIV Diagnostics and Laboratory
Tests Policy").
The
State can use ADAP funds to purchase these
services referenced only if the State demonstrates
to the Secretary that such additional services
are essential and in no way diminish access
to the therapeutics described in subsection
2616(a) of the PHS Act.
Extraordinary
circumstances may include such factors as
demonstrated exceptionally low compliance
and adherence rates among targeted segments
of the clients receiving ADAP medications
(e.g. active substance users, persons with
serious mental illnesses, etc.), or significant
new numbers of clients entering ADAP who
are new recipients of drug therapies (as
a result of other outreach activities) that
necessitate devoting added resources to
these activities. The State must work with
HAB to ensure that any requested use of
ADAP funds for these services above 5 percent
is necessary and appropriate and that existing
ADAP services to clients will not be diminished
or disrupted.
B.
There are no current limitations to accessing
ADAP in the State, including:(1) no client
waiting list or limits on client enrollment;
(2) no restrictions or limitation on HIV
medications, such as caps on the number
of prescriptions or cost to the client (such
as co-pays), except for purposes of clinical
quality assurance or the prevention of fraud
and abuse; and (3) administrative support
is maintained (e.g., administrative support
and eligibility staff.)
C.
There is current, comprehensive coverage
of antiretroviral and opportunistic infection
(OI)/preventive therapies including: (1)
an ADAP formulary that includes a full complement
of PHS recommended antiretroviral medications;
and (2) medication necessary for the prophylaxis
and treatment of opportunistic infections.Compliance
with formulary coverage may be adjusted
or modified based on the State's alternative
methods of providing comprehensive pharmacy
coverage (e.g., health insurance, or Stated-funded
pharmacy assistance program).Section 2616(c)(1)
of the PHS Act requires that the State "shall ensure that the therapeutics included on the list of classes of
core antiretroviral therapeutics established
by the Secretary under subsection (e) are,
at a minimum, the treatments provided by
the State pursuant to this section;"Under
subsection (e) of that same section, it
states "For
purposes of subsection (c)(1),
the Secretary shall develop and maintain
a list of classes of core antiretroviral
therapeutics, which list shall be based
on the therapeutics included in the guidelines
of the Secretary known as the Clinical Practice
Guidelines for Use of HIV/AIDS drugs, relating
to drugs needed to manage symptoms associated
with HIV."In a letter dated February
15, 2007 (see attachment) from Dr. Deborah
Parham Hopson, Associate Administrator of
HAB, Part B Program Directors were informed
that the current United States PHS Clinical
Practice Guidelines identify 1) Non-nucleoside
Reverse Transcriptase Inhibitors; 2) Nucleoside/Nucleotide
Analogues; 3) Protease Inhibitors; and 4)
Fusion Inhibitors as the classes of approved
antiretrovirals for the treatment of HIV
infection and that all ADAPs must include
agents from each of the classes in their
FY 2007 formulary.(The PHS
Guidelines can be found at the following
website: ).
II.
It is expected that no more than 5 percent
of ADAP funds will be used to purchase services
referenced in I. A, items (1) - (3) above;
and up to 10 percent under extraordinary
circumstances and in agreement with HAB
staff.
III.
In addition:
A.
The grantee will work with HAB staff to
ensure the grantee's plan to redirect ADAP
funds still meets the core purposes of ADAP.
B.
The Ryan White HIV/AIDS Program must be
the payer of last resort.Grantees must be
capable of providing the HAB with documentation
related to the use of funds as payer of
last resort and the coordination of such
funds with other local, State, and Federal
funds.For example, the grantee should back
bill Medicaid for Ryan White HIV/AIDS Program
services provided to Medicaid eligible individuals.In
addition, funds received under the Ryan
White HIV/AIDS Program, including ADAP,
must be used to supplement, but not supplant,
funds currently being used from local, State,
and Federal agency programs.
C.
The grantee must have a mechanism to report
on the use of redirected funds.For example,
an estimation of unspent funds, including
carryover, the impact of such services in
improving access and use of ADAP-funded medications,
and any procedural plans to shift funds back
to purchasing medications.
D.The
request to provide additional services with
ADAP funds must be submitted on an annual
basis either through the grant application
process or by requesting prior approval
from Resources and Services Administration's
Division of Grants Management Operations
during the year.
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