CMS Waiver Instructions

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Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Notices
pharmacology reviews of pediatric
studies conducted for ABILIFY
(aripiprazole), ANDROGEL
(testosterone), and DIOVAN (valsartan).
The summaries are being made available
consistent with section 9 of the 2002
BPCA (Public Law 107–109). Enacted on
January 4, 2002, the 2002 BPCA
reauthorized, with certain important
changes, the pediatric exclusivity
program described in section 505A of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 355a). Section
505A of the act permits certain
applications to obtain 6 months of
marketing exclusivity if, in accordance
with the requirements of the statute, the
sponsor submits requested information
relating to the use of the drug in the
pediatric population.
One of the provisions the 2002 BPCA
added to the pediatric exclusivity
program pertains to the dissemination of
pediatric information. Specifically, for
all pediatric supplements submitted
under the 2002 BPCA, the 2002 BPCA
required FDA to make available to the
public, including by publication in the
Federal Register, a summary of the
medical and clinical pharmacology
reviews of pediatric studies conducted
for the supplement within 180 days of
study submission to FDA (21 U.S.C.
355a(j)(1)).
The pediatric exclusivity program
described in section 505A of the act
again was reauthorized on September
27, 2007, in title V of the Food and Drug
Administration Amendments Act
(FDAAA) (Public Law 110–85). FDAAA
revised the public dissemination
provision previously found in 21 U.S.C.
355a(j)(1). As revised, not later than 210
days after the date of submission of a
report on a pediatric study conducted
under the pediatric exclusivity program,
FDA must make available to the public
the medical, statistical, and clinical
pharmacology reviews of the pediatric
studies (21 U.S.C. 355a(k)(1)). Under
FDAAA, publication in the Federal
Register is no longer required. FDA
currently posts these reviews on the
Internet at http://www.fda.gov/cder/
pediatric/BpcaPrea_full_review.htm.
The three sets of summaries being
announced in this issue of the Federal
Register are the last summaries of
reviews of supplements subject to the
2002 BPCA dissemination provision.
Because publication in the Federal
Register is no longer required, this will
be the last notice announcing the
availability of summaries of medical
and clinical pharmacology reviews of
pediatric studies conducted under the
pediatric exclusivity program. FDA has
posted on the Internet at http://
www.fda.gov/cder/pediatric/index.htm

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summaries of medical and clinical
pharmacology reviews of pediatric
studies submitted in supplements for
ABILIFY (aripiprazole), ANDROGEL
(testosterone), and DIOVAN (valsartan).
Copies are also available by mail (see
ADDRESSES).
II. Electronic Access
Persons with access to the Internet
may obtain the document at http://
www.fda.gov/cder/pediatric/index.htm.
Dated: June 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–13099 Filed 6–10–08; 8:45 am]
BILLING CODE 4160–01–S

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:

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/

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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’’.

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(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

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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 costsharing 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/

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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).

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Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Notices

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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.

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33099

Waiver Review and Notification
Process

notice is to reflect the new Order of
Succession for HRSA.

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.

Section R–30, Order of Succession

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
67 FR 46519, July 15, 2002; 68 FR 787–
793, January 7, 2003; 68 FR 8515–8517,
February 21, 2003; 68 FR 64357–64358,
November 13, 2003; 69 FR 56433–
56445, September 21, 2004; 70 FR
19962–19963, April 15, 2005; as last
amended at FR 72 57588–57589,
October 10, 2007). This Order of
Succession supersedes the Order of
Succession for the Administrator,
HRSA, published at FR 72 57588–
57589, October 10, 2007.
This notice deletes the Associate
Administrator, Office of Management,
from HRSA’s hierarchy affecting the
Order of Succession. It also adds, as a
last echelon to the HRSA
Administrator’s order of succession,
HRSA Regional Division Directors in the
order in which they have received their
permanent appointment as such. This

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During the absence or disability of the
Administrator, or in the event of a
vacancy in the office, the officials
designated below shall act as
Administrator in the order in which
they are listed:
1. Deputy Administrator;
2. Senior Advisor to the
Administrator;
3. Chief Financial Officer;
4. Associate Administrator, Bureau of
Primary Health Care;
5. Associate Administrator, Bureau of
Health Professions;
6. Associate Administrator, HIV/AIDS
Bureau;
7. Associate Administrator, Maternal
and Child Health Bureau;
8. Associate Administrator, Bureau of
Clinician Recruitment and Service;
9. Associate Administrator,
Healthcare Systems Bureau;
10. Associate Administrator, Office of
Performance Review, and
11. HRSA Regional Division Directors
in the order in which they have received
their permanent appointment as such.
Exceptions
(a) No official listed in this section
who is serving in acting or temporary
capacity shall, by virtue of so serving,
act as Administrator pursuant to this
section.
(b) Notwithstanding the provisions of
this section, during a planned period of
absence, the Administrator retains the
discretion to specify a different order of
succession.
Section R–40, Delegation of Authority
All delegations and redelegations of
authorities to officers and employees of
the Health Resources and Services
Administration which were in effect
immediately prior to the effective date
of this action will be continued in effect
in them or their successors, pending
further redelegation, provided they are
consistent with this action.
This document is effective upon date
of signature.
Dated: June 5, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8–13098 Filed 6–10–08; 8:45 am]
BILLING CODE 4165–15–P

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