HIV/AIDS Bureau; Ryan White HIV/AIDS Program Core Medical Services Waiver; Application Requirements, 63990-63993 [2013-25276]
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Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days of the receipt
of the FDA letter, to serve as the
nonvoting member to represent the
tobacco manufacturing industry for the
committee. The interested organizations
are not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner of Food and Drugs
will select the nonvoting member to
represent industry interests.
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III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
contact person (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and therefore, encourages
nominations of appropriately qualified
candidates from these groups.
Specifically, in this document,
nominations for nonvoting
representatives of industry interests are
encouraged from the tobacco
manufacturing industry.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
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Dated: October 21, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–25188 Filed 10–24–13; 8:45 am]
BILLING CODE 4160–01–P
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
Health Resources and Services
Administration, HHS.
ACTION: Final notice.
AGENCY:
Title XXVI of the Public
Health Service Act, as amended by the
Ryan White HIV/AIDS Treatment
Extension Act of 2009 (Ryan White
Program or RWHAP), 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 statute. The
statute also grants the Secretary
authority to waive this requirement if
there are no waiting lists for the AIDS
Drug Assistance Program (ADAP) and
core medical services are available to all
individuals identified and eligible
under Title XXVI in an applicant’s state,
jurisdiction, or service area, as
applicable.
The requirements for submitting an
application to waive the statutory
requirement that a grantee spend at least
75 percent of its funds on core medical
were previously outlined in HIV/AIDS
Bureau (HAB) Policy Notice 08–02. On
May 24, 2013, the Health Resources and
Services Administration (HRSA)
published a Final Notice with
Opportunity to Comment in the Federal
Register, revising HAB Policy Notice
08–02, and requesting public comment
on this revised policy. This Federal
Register notice seeks to address
comments made by the public and to
implement this policy as originally
written.
DATES: The policy will become effective
on September 23, 2013.
SUPPLEMENTARY INFORMATION: HRSA
received several comments on the
waiver application process published in
the Federal Register. Overall, the
comments were supportive of the
revised requirements. Commenters
indicated that the revised application
process will provide grantees with the
flexibility to adjust resource allocation
SUMMARY:
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based on the current situation in their
local environment.
Several commenters suggested that
the application process and the
documentation required to apply for a
waiver was burdensome, especially for
grantees with limited administrative
staff to respond to the waiver
requirements. HRSA believes that the
application process and the
documentation required are necessary
for the agency to understand the
availability of core medical services in
the applicant’s state, jurisdiction, or
service area, as applicable. This
required documentation is intended to
provide HRSA with sufficient
information to make an informed
decision on each waiver request and to
understand the availability of core
medical services in a grantee’s state,
jurisdiction, or service area, as
applicable. Further, the requirements
are similar to those under the previous
policy. Waiver applicants under the
previous policy were expected to
provide adequate documentation, which
may have included additional data,
supporting letters, and other
information that justified the need for
the waiver. As such, HRSA is only
clarifying what documentation is
necessary to meet each requirement in
the application. This will ensure that
the applicant provides adequate
documentation to demonstrate the need
for a waiver of the core medical services
requirement
Under the previous policy, letters
from Medicaid directors and other State
and local HIV/AIDS entitlement and
benefits programs, which may include
private insurers, were optional. Under
this revision, item #2(c) of the policy
now requires the submission of
documentation regarding the
availability of relevant services, and
lists examples of the types of programs
that may provide documentation,
including private insurers. Specific to
this requirement, several commenters
suggested that letters from private
insurers would be burdensome to
provide. HRSA wishes to clarify that
letters from private insurers are not
required; these entities are only listed to
provide an example of a type of
entitlement and benefit provider. Other
types of entitlement and benefit
providers might include local
foundations that provide funding for
medical care to low-income HIV
patients or a county or state sponsored
drug-assistance program. As part of their
application, grantees must provide
letters from the state Medicaid Director
and relevant HIV/AIDS entitlement and
benefits programs available in their
state, jurisdiction, or service area, as
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applicable, to document the availability
and accessibility of core medical
services.
Several commenters pointed out that
it would be burdensome for grantees to
conduct a separate public process
around the annual waiver application.
HRSA wishes to clarify that while a
grantee may conduct a separate public
process around the waiver application,
they are not required to do so. Grantees
must seek feedback on their waiver
application from the public, but may do
so through any public process that the
grantee already uses, including those
that are used to obtain input on
community needs as part of the annual
priority setting and resource allocation,
comprehensive planning, Statewide
Coordinated Statement of Need, public
planning, and/or needs assessment
process. This requirement has not
changed from the previous policy.
Another commenter requested that
HRSA not include the waiver
attachments and documentation
requirements as part of the application’s
10-page limit listed in requirement #4.
HRSA wishes to clarify that the page
limit only applies to the narrative
section described in requirement #4.
The documentation required by the
other sections does not count towards
the page limit outlined in the policy.
Another commenter mentioned
concern regarding ‘‘outreach and
linkage of HIV-positive individuals not
currently in care’’ being considered a
non-core service in the requirement
#4(c) of the policy. The commenter
indicated that outreach and linkage to
care fell under early intervention
services, and as such should not be
considered a non-core service. HRSA
wishes to clarify that section #4(c) of the
policy is specifically referring to
outreach and linkage to care as a
support service, not early intervention
services, which, as the commenter
mentioned, are core medical services. In
42 U.S.C. 300ff–14(d)(1), 300ff–22(c)(1),
300ff–51(d)(1), outreach services are
identified as support services. In
addition, HAB policy 12–01 identifies
outreach services as a service ‘‘which
has as their principal purpose targeting
activities, under specific needs
assessment-based service categories that
can identify individuals with HIV
disease. This includes those who know
their HIV status and are not in care as
well as those individuals who are
unaware of their HIV status, so that they
become aware of the availability of HIVrelated services and enroll in primary
care, AIDS Drug Assistance Programs,
and support services that enable them to
remain in care.’’
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Another commenter suggested that
the requirement that all core services be
available within 30 days is not
reasonable. 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 (See Medicare
Managed Care Manual, Chapter 4
Benefits and Beneficiary Protections,
section 110.1 Access and Availability
Rules for Coordinated Care Plans at
https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/
downloads/mc86c04.pdf.). In addition,
the RWHAP legislation specifies that
core medical services must be
‘‘available.’’ This requirement has not
changed from previous versions of this
policy. 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.
Other commenters suggested that the
application acceptance timeframe be
changed to a rolling basis, rather than
requiring that waiver applications be
submitted before, during, or after
application deadlines, or that waiver
applications be preapproved, with
complete documentation submitted only
when the grantee invokes the waiver.
While HRSA agrees that these methods
may be more straightforward, the
current process and timelines used to
manage and monitor grant applications
makes either of these processes not
feasible for HRSA.
This Final Notice reaffirms HRSA’s
position that these revisions to HAB
Policy Notice 08–02 are intended to
clarify the waiver process and respond
to the changing needs of the grantee
community, while at the same time
ensuring that the waiver process is fair
and sufficiently robust so that HRSA is
able to undertake appropriate review.
The policy will remain in effect, as
originally published, and will be
identified as HAB Policy Notice 13–07.
Policy
Uniform Standard for Waiver of Core
Medical Services Requirement for
Grantees Under Parts, A, B, and C
POLICY NUMBER 13–07 (Replaces
Policy Notice 08–02).
Scope of Policy
PO 00000
Ryan White Parts A, B, C.
Frm 00033
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63991
Summary and Purpose of Policy
The purpose of this policy is to
outline the Health Resources and
Services Administration (HRSA) HIV/
AIDS Bureau (HAB) requirements for
applying for a waiver of the requirement
that 75 percent of Ryan White HIV/AIDS
program funds be spent on core medical
services.
Background
Title XXVI of the Public Health
Service Act, Part A section 2604(c), Part
B section 2612(b), and Part C section
2651(c) requires that grantees expend
not less than 75 percent of their grant
funds on core medical services. These
sections also grant the Secretary
authority to waive this requirement if
there are no waiting lists for the AIDS
Drug Assistance Program (ADAP) and
core medical services are available to all
individuals identified and eligible
under Title XXVI in an applicant’s
service area.
Policy
Grantees may submit a waiver request
at any time prior to submission of the
annual grant application, along with the
annual grant application, or up to 4
months after the start of the grant year
for which a waiver is being requested.
Applications submitted before or after
an annual grant application have
different requirements than those
submitted with an annual grant
application. Applicants should choose
the method that best meets their needs.
The requirements for each process are
outlined below.
Requirements To Apply for a Waiver
Before or After an Annual Grant
Application
This section outlines the requirements
to submit a waiver application: (1) In
advance of a grantee’s annual grant
application or (2) after the grant
application has been submitted up to 4
months into the grant year for which a
waiver is being requested. Waiver
requests must be submitted through the
EHB Prior Approval portal and must
identify the grant year for which the
waiver is being requested. The waiver
request must be signed by the chief
elected official or the Project Director,
and include the following
documentation that will be utilized by
HRSA in determining whether to grant
the waiver:
1. Letter signed by the Director of the
Part B State/Territory Grantee indicating
that there is no current or anticipated
ADAP services waiting list in the State/
Territory.
2. Evidence that all core medical
services listed in the statute (Part A
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25OCN1
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Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices
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 and
accessible within 30 days for all
identified and eligible individuals with
HIV/AIDS in the service area, without
need to expend at least 75 percent of
Ryan White funds on these services.
Acceptable evidence must include all of
the following:
a. HIV/AIDS care and treatment
services inventories, including
identification of the specific core
medical services available, from whom,
and through what funding source;
b. HIV/AIDS client/patient service
utilization data in addition to what has
previously been submitted via the Ryan
White Services Report (RSR); and
c. Letters from Medicaid and other
State and local HIV/AIDS entitlement
and benefits programs, which may
include private insurers.
3. Evidence of a public process, which
documents that the applicant has sought
input from affected communities;
including consumers and the 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 that is utilized for obtaining input
on community needs as part of the
annual priority setting and resource
allocation, comprehensive planning,
Statewide Coordinated Statement of
Need (SCSN), public planning, and/or
needs assessment process. Acceptable
evidence must, at a minimum, include:
a. Letters from both the Planning
Council Chair in the Metropolitan area
(if grantee serves such area) and the
State HIV/AIDS Director describing the
public process that occurred in each
jurisdiction.
4. A narrative of up to, but no more
than, 10 pages that explains each item
in a. through d. below:
a. Any underlying State or local issues
that influenced the grantee’s decision to
request a waiver.
b. How the documentation submitted
under item two supports the assertion
that such core services are available and
accessible to all individuals with HIV/
AIDS, identified and eligible under Title
XXVI in the service area.
c. How the approval of a waiver will
positively contribute to the grantee’s
ability to address service needs for HIV/
AIDS non-core services. Specifically
address the grantee’s ability to perform
outreach and linkage of HIV-positive
individuals not currently in care.
d. How the receipt of the core medical
services waiver will allow for
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17:55 Oct 24, 2013
Jkt 232001
implementation consistent with the
applicant’s proposed percentage
allocation of resources, comprehensive
plan, and SCSN. Applicants must also
document consistency by providing a
proposed allocation table.
Waiver Review and Notification
Process
HRSA/HAB will review the request
and notify grantees of waiver approval
or denial within eight weeks of receipt
of the request. Core medical services
waivers will be effective for the grant
award period for which it is approved.
Subsequent grant periods will require a
new waiver request. Grantees that are
approved for a core medical services
waiver in advance of their annual grant
application are not compelled to utilize
the waiver should circumstances
change.
Requirements To Apply for a Waiver
With the Annual Grant Application
This section provides guidance for
grantees who wish to submit a waiver
request with their annual grant
application. Waiver requests must be
submitted as an attachment to the
grantee’s annual grant application and
should not be submitted through the
EHB Prior Approval portal. The waiver
request must be signed by the chief
elected official or the Project Director,
and include the following
documentation that will be utilized by
HRSA in determining whether to grant
the waiver:
1. Letter signed by the Director of the
Part B State/Territory Grantee indicating
that there is no current or anticipated
ADAP services waiting list in the State/
Territory.
2. Evidence 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 and
accessible within 30 days for all
identified and eligible individuals with
HIV/AIDS in the service area, without
need to expend at least 75 percent of
Ryan White funds on these services.
Acceptable evidence must include all of
the following:
a. HIV/AIDS care and treatment
services inventories, including
identification of the specific core
medical services available, from whom,
and through what funding source;
b. HIV/AIDS client/patient service
utilization data in addition to what has
previously been submitted via the Ryan
White Services Report (RSR); and
c. Letters from Medicaid and other
State and local HIV/AIDS entitlement
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and benefits programs, which may
include private insurers.
3. Evidence of a public process, which
documents that the applicant has sought
input from affected communities;
including consumers and the 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 that is utilized for obtaining input
on community needs as part of the
annual priority setting and resource
allocation, comprehensive planning,
Statewide Coordinated Statement of
Need (SCSN), public planning, and/or
needs assessment process. Acceptable
evidence must, at a minimum, include:
a. Letters from both the Planning
Council Chair in the Metropolitan area
(if grantee serves such area) and the
State HIV/AIDS Director describing the
public process that occurred in each
jurisdiction.
4. A narrative of up to, but no more
than, 10 pages that explains each item
in a. through d. below:
a. Any underlying State or local issues
that influenced the grantee’s decision to
request a waiver.
b. How the documentation submitted
under item two supports the assertion
that such core services are available and
accessible to all individuals with HIV/
AIDS, identified and eligible under Title
XXVI in the service area.
c. How the approval of a waiver will
positively contribute to the grantee’s
ability to address service needs for HIV/
AIDS non-core services. Specifically
address the grantee’s ability to perform
outreach and linkage of HIV-positive
individuals not currently in care.
d. How the receipt of the core medical
services waiver is consistent with the
applicant’s grant application,
comprehensive plan, and SCSN.
Applicants must also document
consistency by providing the following:
i. Proposed allocation table, if not
included as part of the grant
application;
AND
ii. (PART A) ‘‘Description of Priority
Setting and Resource Allocation
Processes’’ and ‘‘Unmet Need Estimate
and Assessment’’ sections of the current
grant application;
OR
iii. (PART B) ‘‘Needs Assessment and
Unmet Need’’ section of the current
grant application;
OR
iv. (PART C) ‘‘Description of the Local
HIV Service Delivery System’’ and
‘‘Current and Projected Sources of
Funding’’ sections of the current grant
application.
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Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices
Waiver Review and Notification
Process
HRSA/HAB will review the request
and notify grantees of waiver approval
or denial no later than the date of
issuance of the Notice of Award (NoA).
Core medical services waivers will be
effective for the grant award period for
which it is approved. Subsequent grant
periods will require a new waiver
request. Grantees that are approved for
a core medical services waiver in their
annual grant application are not
compelled to utilize the waiver should
circumstances change.
The Paperwork Reduction Act of 1995
This activity has been reviewed and
approved by the Office of Management
and Budget, under the Paperwork
Reduction Act of 1995 (Control number
0915–0307).
Dated: October 18, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013–25276 Filed 10–24–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
‘‘Low-Income Levels’’ Used for Various
Health Professions and Nursing
Programs
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
updating income levels used to identify
a ‘‘low-income family’’ for the purpose
of determining eligibility for programs
that provide health professions and
nursing training for individuals from
disadvantaged backgrounds. These
various programs are included in Titles
III, VII, and VIII of the Public Health
Service Act.
The Department periodically
publishes in the Federal Register lowincome levels used to determine
eligibility for grants and cooperative
agreements to institutions providing
training for (1) disadvantaged
individuals, (2) individuals from
disadvantaged backgrounds, or (3)
individuals from low-income families.
SUPPLEMENTARY INFORMATION: The
various health professions and nursing
grant and cooperative agreement
programs that use the low-income levels
to determine whether an individual is
from an economically disadvantaged
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SUMMARY:
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background in making eligibility and
funding determinations generally make
awards to: Accredited schools of
medicine, osteopathic medicine, public
health, dentistry, veterinary medicine,
optometry, pharmacy, allied health,
podiatric medicine, nursing,
chiropractic, public or private nonprofit
schools which offer graduate programs
in behavioral health and mental health
practice, and other public or private
nonprofit health or education entities to
assist the disadvantaged to enter and
graduate from health professions and
nursing schools. Some programs
provide for the repayment of health
professions or nursing education loans
for disadvantaged students.
The Secretary defines a ‘‘low-income
family/household’’ for programs
included in Titles III, VII, and VIII of the
Public Health Service Act as having an
annual income that does not exceed 200
percent of the Department’s poverty
guidelines. A family is a group of two
or more individuals related by birth,
marriage, or adoption who live together.
On June 26, 2013, in U.S. v. Windsor,
the Supreme Court held that section 3
of the Defense of Marriage Act, which
prohibited federal recognition of samesex spouses and same-sex marriages,
was unconstitutional. In light of this
decision, please note that same-sex
marriages and same-sex spouses will be
recognized on equal terms with
opposite-sex spouses and opposite-sex
marriages, regardless of where the
couple resides. A ‘‘household’’ may be
only one person. Most HRSA programs
use the income of the student’s parents
to compute low-income status. Other
programs, depending upon the
legislative intent of the program, the
programmatic purpose related to income
level, as well as the age and
circumstances of the participant, will
apply these low income standards to the
individual student to determine
eligibility, as long as he or she is not
listed as a dependent on his or her
parents’ tax form. Each program will
announce the rationale and choice of
methodology for determining lowincome levels in their program
guidance. The Department’s poverty
guidelines are based on poverty
thresholds published by the U.S. Bureau
of the Census, adjusted annually for
changes in the Consumer Price Index.
The Secretary annually adjusts the
low-income levels based on the
Department’s poverty guidelines and
makes them available to persons
responsible for administering the
applicable programs. The income
figures below have been updated to
reflect increases in the Consumer Price
Index through December 31, 2012.
PO 00000
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63993
2013 POVERTY GUIDELINES FOR THE
48 CONTIGUOUS STATES AND THE
DISTRICT OF COLUMBIA
Size of parents’ family *
1
2
3
4
5
6
7
8
................................................
................................................
................................................
................................................
................................................
................................................
................................................
................................................
Income
level **
$22,980
31,020
39,060
47,100
55,140
63,180
71,220
79,260
For families with more than 8 persons, add
$8,040 for each additional person.
2013 POVERTY GUIDELINES FOR
ALASKA
Size of parents’ family*
1
2
3
4
5
6
7
8
................................................
................................................
................................................
................................................
................................................
................................................
................................................
................................................
Income
level**
$28,700
38,760
48,820
58,880
68,940
79,000
89,060
99,120
For families with more than 8 persons, add
$10,060 for each additional person.
2013 POVERTY GUIDELINES FOR
HAWAII
Size of parents’ family *
1
2
3
4
5
6
7
8
................................................
................................................
................................................
................................................
................................................
................................................
................................................
................................................
Income
level **
$26,460
35,700
44,940
54,180
63,420
72,660
81,900
91,140
For families with more than 8 persons, add
$9,240 for each additional person.
* Includes only dependents listed on federal
income tax forms. Some programs will use the
student’s family rather than his or her parents’
family.
** Adjusted gross income for calendar year
2012.
Separate poverty guidelines figures
for Alaska and Hawaii reflect Office of
Economic Opportunity administrative
practice beginning in the 1966–1970
period. (Note that the Census Bureau
poverty thresholds—the version of the
poverty measure used for statistical
purposes—have never had separate
figures for Alaska and Hawaii). The
poverty guidelines are not defined for
Puerto Rico or other outlying
jurisdictions. Puerto Rico or other
outlying jurisdictions shall use income
guidelines for the 48 contiguous states
and the District of Columbia.
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]]>Agencies
[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Notices]
[Pages 63990-63993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25276]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: Title XXVI of the Public Health Service Act, as amended by the
Ryan White HIV/AIDS Treatment Extension Act of 2009 (Ryan White Program
or RWHAP), 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 statute.
The statute also grants the Secretary authority to waive this
requirement if there are no waiting lists for the AIDS Drug Assistance
Program (ADAP) and core medical services are available to all
individuals identified and eligible under Title XXVI in an applicant's
state, jurisdiction, or service area, as applicable.
The requirements for submitting an application to waive the
statutory requirement that a grantee spend at least 75 percent of its
funds on core medical were previously outlined in HIV/AIDS Bureau (HAB)
Policy Notice 08-02. On May 24, 2013, the Health Resources and Services
Administration (HRSA) published a Final Notice with Opportunity to
Comment in the Federal Register, revising HAB Policy Notice 08-02, and
requesting public comment on this revised policy. This Federal Register
notice seeks to address comments made by the public and to implement
this policy as originally written.
DATES: The policy will become effective on September 23, 2013.
SUPPLEMENTARY INFORMATION: HRSA received several comments on the waiver
application process published in the Federal Register. Overall, the
comments were supportive of the revised requirements. Commenters
indicated that the revised application process will provide grantees
with the flexibility to adjust resource allocation based on the current
situation in their local environment.
Several commenters suggested that the application process and the
documentation required to apply for a waiver was burdensome, especially
for grantees with limited administrative staff to respond to the waiver
requirements. HRSA believes that the application process and the
documentation required are necessary for the agency to understand the
availability of core medical services in the applicant's state,
jurisdiction, or service area, as applicable. This required
documentation is intended to provide HRSA with sufficient information
to make an informed decision on each waiver request and to understand
the availability of core medical services in a grantee's state,
jurisdiction, or service area, as applicable. Further, the requirements
are similar to those under the previous policy. Waiver applicants under
the previous policy were expected to provide adequate documentation,
which may have included additional data, supporting letters, and other
information that justified the need for the waiver. As such, HRSA is
only clarifying what documentation is necessary to meet each
requirement in the application. This will ensure that the applicant
provides adequate documentation to demonstrate the need for a waiver of
the core medical services requirement
Under the previous policy, letters from Medicaid directors and
other State and local HIV/AIDS entitlement and benefits programs, which
may include private insurers, were optional. Under this revision, item
2(c) of the policy now requires the submission of
documentation regarding the availability of relevant services, and
lists examples of the types of programs that may provide documentation,
including private insurers. Specific to this requirement, several
commenters suggested that letters from private insurers would be
burdensome to provide. HRSA wishes to clarify that letters from private
insurers are not required; these entities are only listed to provide an
example of a type of entitlement and benefit provider. Other types of
entitlement and benefit providers might include local foundations that
provide funding for medical care to low-income HIV patients or a county
or state sponsored drug-assistance program. As part of their
application, grantees must provide letters from the state Medicaid
Director and relevant HIV/AIDS entitlement and benefits programs
available in their state, jurisdiction, or service area, as
[[Page 63991]]
applicable, to document the availability and accessibility of core
medical services.
Several commenters pointed out that it would be burdensome for
grantees to conduct a separate public process around the annual waiver
application. HRSA wishes to clarify that while a grantee may conduct a
separate public process around the waiver application, they are not
required to do so. Grantees must seek feedback on their waiver
application from the public, but may do so through any public process
that the grantee already uses, including those that are used to obtain
input on community needs as part of the annual priority setting and
resource allocation, comprehensive planning, Statewide Coordinated
Statement of Need, public planning, and/or needs assessment process.
This requirement has not changed from the previous policy.
Another commenter requested that HRSA not include the waiver
attachments and documentation requirements as part of the application's
10-page limit listed in requirement 4. HRSA wishes to clarify
that the page limit only applies to the narrative section described in
requirement 4. The documentation required by the other
sections does not count towards the page limit outlined in the policy.
Another commenter mentioned concern regarding ``outreach and
linkage of HIV-positive individuals not currently in care'' being
considered a non-core service in the requirement 4(c) of the
policy. The commenter indicated that outreach and linkage to care fell
under early intervention services, and as such should not be considered
a non-core service. HRSA wishes to clarify that section 4(c)
of the policy is specifically referring to outreach and linkage to care
as a support service, not early intervention services, which, as the
commenter mentioned, are core medical services. In 42 U.S.C. 300ff-
14(d)(1), 300ff-22(c)(1), 300ff-51(d)(1), outreach services are
identified as support services. In addition, HAB policy 12-01
identifies outreach services as a service ``which has as their
principal purpose targeting activities, under specific needs
assessment-based service categories that can identify individuals with
HIV disease. This includes those who know their HIV status and are not
in care as well as those individuals who are unaware of their HIV
status, so that they become aware of the availability of HIV-related
services and enroll in primary care, AIDS Drug Assistance Programs, and
support services that enable them to remain in care.''
Another commenter suggested that the requirement that all core
services be available within 30 days is not reasonable. 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 (See Medicare Managed Care
Manual, Chapter 4 Benefits and Beneficiary Protections, section 110.1
Access and Availability Rules for Coordinated Care Plans at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/mc86c04.pdf.). In addition, the RWHAP legislation specifies that core
medical services must be ``available.'' This requirement has not
changed from previous versions of this policy. 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.
Other commenters suggested that the application acceptance
timeframe be changed to a rolling basis, rather than requiring that
waiver applications be submitted before, during, or after application
deadlines, or that waiver applications be preapproved, with complete
documentation submitted only when the grantee invokes the waiver. While
HRSA agrees that these methods may be more straightforward, the current
process and timelines used to manage and monitor grant applications
makes either of these processes not feasible for HRSA.
This Final Notice reaffirms HRSA's position that these revisions to
HAB Policy Notice 08-02 are intended to clarify the waiver process and
respond to the changing needs of the grantee community, while at the
same time ensuring that the waiver process is fair and sufficiently
robust so that HRSA is able to undertake appropriate review. The policy
will remain in effect, as originally published, and will be identified
as HAB Policy Notice 13-07.
Policy
Uniform Standard for Waiver of Core Medical Services Requirement for
Grantees Under Parts, A, B, and C
POLICY NUMBER 13-07 (Replaces Policy Notice 08-02).
Scope of Policy
Ryan White Parts A, B, C.
Summary and Purpose of Policy
The purpose of this policy is to outline the Health Resources and
Services Administration (HRSA) HIV/AIDS Bureau (HAB) requirements for
applying for a waiver of the requirement that 75 percent of Ryan White
HIV/AIDS program funds be spent on core medical services.
Background
Title XXVI of the Public Health Service Act, Part A section
2604(c), Part B section 2612(b), and Part C section 2651(c) requires
that grantees expend not less than 75 percent of their grant funds on
core medical services. These sections also grant the Secretary
authority to waive this requirement if there are no waiting lists for
the AIDS Drug Assistance Program (ADAP) and core medical services are
available to all individuals identified and eligible under Title XXVI
in an applicant's service area.
Policy
Grantees may submit a waiver request at any time prior to
submission of the annual grant application, along with the annual grant
application, or up to 4 months after the start of the grant year for
which a waiver is being requested. Applications submitted before or
after an annual grant application have different requirements than
those submitted with an annual grant application. Applicants should
choose the method that best meets their needs. The requirements for
each process are outlined below.
Requirements To Apply for a Waiver Before or After an Annual Grant
Application
This section outlines the requirements to submit a waiver
application: (1) In advance of a grantee's annual grant application or
(2) after the grant application has been submitted up to 4 months into
the grant year for which a waiver is being requested. Waiver requests
must be submitted through the EHB Prior Approval portal and must
identify the grant year for which the waiver is being requested. The
waiver request must be signed by the chief elected official or the
Project Director, and include the following documentation that will be
utilized by HRSA in determining whether to grant the waiver:
1. Letter signed by the Director of the Part B State/Territory
Grantee indicating that there is no current or anticipated ADAP
services waiting list in the State/Territory.
2. Evidence that all core medical services listed in the statute
(Part A
[[Page 63992]]
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 and accessible within 30 days for
all identified and eligible individuals with HIV/AIDS in the service
area, without need to expend at least 75 percent of Ryan White funds on
these services. Acceptable evidence must include all of the following:
a. HIV/AIDS care and treatment services inventories, including
identification of the specific core medical services available, from
whom, and through what funding source;
b. HIV/AIDS client/patient service utilization data in addition to
what has previously been submitted via the Ryan White Services Report
(RSR); and
c. Letters from Medicaid and other State and local HIV/AIDS
entitlement and benefits programs, which may include private insurers.
3. Evidence of a public process, which documents that the applicant
has sought input from affected communities; including consumers and the
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 that is
utilized for obtaining input on community needs as part of the annual
priority setting and resource allocation, comprehensive planning,
Statewide Coordinated Statement of Need (SCSN), public planning, and/or
needs assessment process. Acceptable evidence must, at a minimum,
include:
a. Letters from both the Planning Council Chair in the Metropolitan
area (if grantee serves such area) and the State HIV/AIDS Director
describing the public process that occurred in each jurisdiction.
4. A narrative of up to, but no more than, 10 pages that explains
each item in a. through d. below:
a. Any underlying State or local issues that influenced the
grantee's decision to request a waiver.
b. How the documentation submitted under item two supports the
assertion that such core services are available and accessible to all
individuals with HIV/AIDS, identified and eligible under Title XXVI in
the service area.
c. How the approval of a waiver will positively contribute to the
grantee's ability to address service needs for HIV/AIDS non-core
services. Specifically address the grantee's ability to perform
outreach and linkage of HIV-positive individuals not currently in care.
d. How the receipt of the core medical services waiver will allow
for implementation consistent with the applicant's proposed percentage
allocation of resources, comprehensive plan, and SCSN. Applicants must
also document consistency by providing a proposed allocation table.
Waiver Review and Notification Process
HRSA/HAB will review the request and notify grantees of waiver
approval or denial within eight weeks of receipt of the request. Core
medical services waivers will be effective for the grant award period
for which it is approved. Subsequent grant periods will require a new
waiver request. Grantees that are approved for a core medical services
waiver in advance of their annual grant application are not compelled
to utilize the waiver should circumstances change.
Requirements To Apply for a Waiver With the Annual Grant Application
This section provides guidance for grantees who wish to submit a
waiver request with their annual grant application. Waiver requests
must be submitted as an attachment to the grantee's annual grant
application and should not be submitted through the EHB Prior Approval
portal. The waiver request must be signed by the chief elected official
or the Project Director, and include the following documentation that
will be utilized by HRSA in determining whether to grant the waiver:
1. Letter signed by the Director of the Part B State/Territory
Grantee indicating that there is no current or anticipated ADAP
services waiting list in the State/Territory.
2. Evidence 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 and accessible within 30
days for all identified and eligible individuals with HIV/AIDS in the
service area, without need to expend at least 75 percent of Ryan White
funds on these services. Acceptable evidence must include all of the
following:
a. HIV/AIDS care and treatment services inventories, including
identification of the specific core medical services available, from
whom, and through what funding source;
b. HIV/AIDS client/patient service utilization data in addition to
what has previously been submitted via the Ryan White Services Report
(RSR); and
c. Letters from Medicaid and other State and local HIV/AIDS
entitlement and benefits programs, which may include private insurers.
3. Evidence of a public process, which documents that the applicant
has sought input from affected communities; including consumers and the
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 that is
utilized for obtaining input on community needs as part of the annual
priority setting and resource allocation, comprehensive planning,
Statewide Coordinated Statement of Need (SCSN), public planning, and/or
needs assessment process. Acceptable evidence must, at a minimum,
include:
a. Letters from both the Planning Council Chair in the Metropolitan
area (if grantee serves such area) and the State HIV/AIDS Director
describing the public process that occurred in each jurisdiction.
4. A narrative of up to, but no more than, 10 pages that explains
each item in a. through d. below:
a. Any underlying State or local issues that influenced the
grantee's decision to request a waiver.
b. How the documentation submitted under item two supports the
assertion that such core services are available and accessible to all
individuals with HIV/AIDS, identified and eligible under Title XXVI in
the service area.
c. How the approval of a waiver will positively contribute to the
grantee's ability to address service needs for HIV/AIDS non-core
services. Specifically address the grantee's ability to perform
outreach and linkage of HIV-positive individuals not currently in care.
d. How the receipt of the core medical services waiver is
consistent with the applicant's grant application, comprehensive plan,
and SCSN. Applicants must also document consistency by providing the
following:
i. Proposed allocation table, if not included as part of the grant
application;
AND
ii. (PART A) ``Description of Priority Setting and Resource
Allocation Processes'' and ``Unmet Need Estimate and Assessment''
sections of the current grant application;
OR
iii. (PART B) ``Needs Assessment and Unmet Need'' section of the
current grant application;
OR
iv. (PART C) ``Description of the Local HIV Service Delivery
System'' and ``Current and Projected Sources of Funding'' sections of
the current grant application.
[[Page 63993]]
Waiver Review and Notification Process
HRSA/HAB will review the request and notify grantees of waiver
approval or denial no later than the date of issuance of the Notice of
Award (NoA). Core medical services waivers will be effective for the
grant award period for which it is approved. Subsequent grant periods
will require a new waiver request. Grantees that are approved for a
core medical services waiver in their annual grant application are not
compelled to utilize the waiver should circumstances change.
The Paperwork Reduction Act of 1995
This activity has been reviewed and approved by the Office of
Management and Budget, under the Paperwork Reduction Act of 1995
(Control number 0915-0307).
Dated: October 18, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013-25276 Filed 10-24-13; 8:45 am]
BILLING CODE 4165-15-P
