Secretary's Advisory Committee on Genetics, Health, and Society; Office of the Secretary, HHS; Request for Public Comment, 17085-17086 [05-6614]
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Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices
Board of Governors of the Federal Reserve
System, March 29, 2005.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 05–6524 Filed 4–1–05; 8:45 am]
BILLING CODE 6210–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Secretary’s Advisory Committee on
Genetics, Health, and Society; Office of
the Secretary, HHS; Request for Public
Comment
Request for public comment on
a draft report on coverage and
reimbursement of genetic tests and
services.
ACTION:
SUMMARY: The Secretary’s Advisory
Committee on Genetics, Health, and
Society (SACGHS) is requesting public
comment on a draft report on coverage
and reimbursement of genetic tests and
services.
DATES: Written or electronic comments
should be submitted by May 6, 2005.
ADDRESSES: Comments can be sent by
mail to the following address:
Secretary’s Advisory Committee on
Genetics, Health, and Society, attn:
Suzanne Goodwin, NIH Office of
Biotechnology Activities, 6705
Rockledge Drive, Suite 750, Bethesda,
MD, 20892. Comments also can be sent
via e-mail to Suzanne Goodwin at
goodwins@od.nih.gov or via facsimile to
301–496–9839.
FOR FURTHER INFORMATION CONTACT:
Suzanne Goodwin, NIH Office of
Biotechnology Activities, 6705
Rockledge Drive, Suite 750, Bethesda,
MD 20892, 301–496–9838,
goodwins@od.nih.gov.
The
Department of Health and Human
Services (HHS) established SACGHS to
serve as a public forum for deliberations
on the broad range of human health and
societal issues raised by the
development and use of genetic
technologies and, as warranted, to
provide advice on these issues. For
more information about the Committee,
please visit its Web site: https://
www4.od.nih.gov/oba/sacghs.htm.
In its first year, SACHGS identified
coverage and reimbursement of genetic
tests and services as a high priority
because there are significant barriers to
coverage and reimbursement as well as
unmet data needs that are currently
limiting appropriate access and clinical
integration.
Its report, Coverage and
Reimbursement of Genetic Tests and
SUPPLEMENTARY INFORMATION:
VerDate jul<14>2003
15:19 Apr 01, 2005
Jkt 205001
Services, describes the current state of,
and problems associated with, coverage
and reimbursement for genetic tests and
services and offers recommendations on
how current mechanisms for coverage
and reimbursement for genetic tests and
services might be improved. Once
finalized, the report and
recommendations will be transmitted to
the Secretary of Health and Human
Services.
SACGHS proposing to make the
following recommendations in its report
to the Secretary:
1. The Secretary should task an
appropriate group or body to develop a
set of principles to guide coverage
decision making for genetic tests. The
principles should identify criteria to
help determine which types or
categories of genetic tests should be
covered, which should not be covered,
and which fall into an uncertain gray
zone. The group’s guiding principles
should address the issues of economic
evaluation/cost-effectiveness,
prevention, rare disease tests, and
therapeutic versus informational
benefit. The Committee also
recommends that the existing evidence
for specific tests be assessed in order to
determine whether the evidence is
adequate in type, quality, and quantity
to establish analytical validity, clinical
validity and clinical utility as well as to
identify any gaps in evidence.
This body should include both
relevant HHS agencies and private
organizations and utilize resources of
models in the public and private sector.
The Evaluation of Genomic
Applications in Practice and Prevention
Work Group organized by the Centers
for Disease Control and Prevention
involves such a diverse range of
stakeholders and is performing similar
work and, thus, is an example of such
a body to be tasked to develop these
principles and address these issues.
The Committee also recommends a
mechanism be established that would
specifically promote and fund studies to
address any identified gaps in the
evidence base.
2. Genetic tests and services in
pediatrics and those with a prevention
component should be considered
specifically with respect to the benefits
they can offer the populations they
serve. Although standardization of
coverage decisions using best scientific
evidence across public and private
payers is ideal (see Recommendation 1),
private payers should be supported with
necessary information to make their
own coverage determinations about
these tests and services relative to the
populations they serve.
PO 00000
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Fmt 4703
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17085
3. Although a mixed national-local
coverage decision-making process is a
reasonable approach to making
Medicare coverage decision for genetic
tests and services, there are several
aspects of the current national-local
decision-making process that limit its
utility. While not suggesting changes to
the current system, SACGHS
recommends that the Secretary
encourage the Centers for Medicare &
Medicaid Services (CMS) to move
forward with the implementation of
Section 731 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003, which
requires the development of a plan to
evaluate new local coverage decisions to
determine which should be adopted
nationally and to what extent greater
consistency in Medicare coverage policy
can be achieved.
4. Medicare beneficiaries who lack
current signs, symptoms, or personal
histories of illness stand to clinically
benefit from predictive and
predispositional genetic tests and
services. As such, SACGHS
recommends that preventive services,
including predispositional genetic tests
and services, meeting evidence
standards should be covered under
Medicare.
The Secretary should urge Congress to
add a benefit category for preventive
services that would enable CMS to
determine through its national coverage
decision-making process, which
includes an assessment of existing
evidence, whether an item or service is
reasonable and necessary for the
prevention or early detection of an
illness or disability and, thus, ought to
be covered. Such action would allow
CMS to consider covering many more
genetic tests and services that are used
for preventive purposes.
More immediately, the Secretary
should direct CMS to clarify, through
appropriate guidance, that in certain
circumstances and where scientific
evidence warrants, ‘‘personal history’’
may include family history of a
particular disease for purposes of
establishing that a genetic test is
‘‘reasonable and necessary’’ and,
therefore, covered under Medicare. CMS
should specify the circumstances and
criteria required to make such a
determination.
5. The Secretary should broadly
disseminate to all states information
about the existing evidence base and
other supporting information, such as
guiding principles that serve as the basis
for coverage decision-making, on
genetic tests and services. This
information could be utilized by the
E:\FR\FM\04APN1.SGM
04APN1
17086
Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices
states to inform their Medicaid coverage
decisions.
HHS should continue to provide
states with grants that encourage the
coverage, adoption and provision of
genetic services that have a sound
evidence base.
6. In many cases, payment rates for
genetic tests are lower than the actual
cost of performing the test. Until the fee
schedule can be reconsidered in a
comprehensive way, the Secretary
should direct CMS to address variations
in payment rates for the genetic test
Current Procedural Terminology (CPT)
codes through its inherent
reasonableness authority.
7. Genetic counseling is a critically
important component of the appropriate
use and integration of genetic tests and
services. As such, SACGHS
recommends the following:
• Qualified health providers should
be allowed to bill directly for genetic
counseling services. The Secretary
should expeditiously identify an
appropriate mechanism for determining
the credentials and criteria needed for a
health provider to be deemed qualified
to provide genetic counseling services
and eligible to bill directly for them.
• The Secretary should direct
government programs to reimburse
prolonged service codes when
determined to be reasonable and
necessary.
• HHS, with input from the various
providers of genetic counseling services,
should assess the adequacy of existing
CPT Evaluation & Management (E&M)
codes and their associated relative
values with respect to genetic
counseling services. Any inadequacies
identified should be addressed as
deemed appropriate.
• CMS should deem all nonphysician health providers who are
currently permitted to bill directly any
health plan—public or private—eligible
for a National Provider Identifier.
• The Secretary should direct CMS to
allow non-physician health
professionals who are qualified to
provide genetic counseling services and
who currently bill incident to a
physician to utilize the full range of CPT
E&M codes available for genetic
counseling services.
8. Since providers act as
intermediaries between health plans
and plan members and thus have an
important role in ensuring genetic tests
and services are provided appropriately,
there is a need to support the ongoing
training and continued education of
health providers in genetics and
genomics. SACGHS’s recommendations
to the Secretary in 2004 included the
following: the Secretary should develop
VerDate jul<14>2003
15:19 Apr 01, 2005
Jkt 205001
a plan for HHS agencies to work
collaboratively with state, federal and
private organizations to support the
development, cataloguing and
dissemination of case studies and
practice models that demonstrate the
current relevance of genetics and
genomics; and the Secretary should
strive to incorporate genetics and
genomics into relevant initiatives of
HHS, including the National Health
Information Infrastructure.
9. Reliable and trustworthy
information about family history,
genetics and genetic technologies
should be developed and made more
widely available through the internet
and other mechanisms that allow
patients and consumers to evaluate
health plan benefits and health
providers so that they may make the
most appropriate and most financially
responsible decisions for themselves
and their families.
The Secretary should leverage HHS
resources to develop and make widely
available reliable and trustworthy
information about genetics and genetic
technologies to guide and promote
informed decision making by healthcare
consumers and providers. Such
information should be made available
though federal government Web sites
and other appropriate mechanisms.
The full report is available
electronically at https://
www4.od.nih.gov/oba/sacghs/
public_comments.htm. A paper or
electronic copy also can be requested by
calling the NIH Office of Biotechnology
Activities at 301–496–9838– or by emailing Suzanne Goodwin at
goodwins@od.nih.gov.
SACGHS is requesting comments on
these recommendations and the overall
content of the draft report. Public
comments received by May 6, 2005, will
be considered by SACGHS in preparing
the final report. The report and the
public comments will be discussed at
SACGHS’s next meeting on June 15–16,
2005, in Bethesda, MD. Comments also
will be available for public inspection at
the NIH Office of Biotechnology
Activities Monday through Friday
between the hours of 8:30 a.m. and 5
p.m.
Dated: March 28, 2005.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–6614 Filed 4–1–05; 8:45 am]
BILLING CODE 4140–01–M
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Preventing Sexual and Intimate Partner
Violence Within Racial/Ethnic Minority
Communities
Announcement Type: New.
Funding Opportunity Number: RFA
05043.
Catalog of Federal Domestic
Assistance Number: 93.136.
Key Dates: Letter of Intent Deadline:
May 4, 2005.
Application Deadline: May 19, 2005.
I. Funding Opportunity Description
Authority: This program is authorized
under section 391(a) of the Public Health
Service Act (PHS Act), 42 U.S.C. 280b(a),
section 393 of the PHS Act, 42 U.S.C. 280b–
1a.
Background
The National Violence Against
Women Survey (NVAWS) reports that
approximately 1.5 million women are
raped and/or physically assaulted by an
intimate partner each year. Violence
against women is a significant public
health and criminal justice concern
which disproportionately affects
marginalized groups such as racial and
ethnic minorities. This study further
reports the racial and ethnic differences
in the lifetime rates of rape, for example
American Indian/Alaska Native women
were identified as having almost twice
the rate of African American or White
women. Specifically, American Indian/
Alaska Native women (34 percent) were
significantly more likely to report that
they were raped than African American
women (19 percent) or White women
(18 percent). The survey also found that
women who identified themselves as
Hispanic (14.6 percent) were
significantly less likely to report they
had ever been raped than women who
identified themselves as non-Hispanic
(18.4 percent). Additionally, American
Indian/Alaska Native women (30.7
percent) were most likely to report
Intimate Partner Violence, and Asian/
Pacific Islander women (12.8 percent)
were least likely to report Intimate
Partner Violence. Other racial
differences illustrate that close to onethird of African American women
experience intimate partner violence in
their lifetimes compared with onefourth of White women. Furthermore,
when you consider the rates for the
most severe form of intimate partner
violence, which is homicide, African
American women (3.55) are three times
as likely than White women (1.11) to die
E:\FR\FM\04APN1.SGM
04APN1
]]>Agencies
[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Notices]
[Pages 17085-17086]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6614]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Secretary's Advisory Committee on Genetics, Health, and Society;
Office of the Secretary, HHS; Request for Public Comment
ACTION: Request for public comment on a draft report on coverage and
reimbursement of genetic tests and services.
-----------------------------------------------------------------------
SUMMARY: The Secretary's Advisory Committee on Genetics, Health, and
Society (SACGHS) is requesting public comment on a draft report on
coverage and reimbursement of genetic tests and services.
DATES: Written or electronic comments should be submitted by May 6,
2005.
ADDRESSES: Comments can be sent by mail to the following address:
Secretary's Advisory Committee on Genetics, Health, and Society, attn:
Suzanne Goodwin, NIH Office of Biotechnology Activities, 6705 Rockledge
Drive, Suite 750, Bethesda, MD, 20892. Comments also can be sent via e-
mail to Suzanne Goodwin at goodwins@od.nih.gov or via facsimile to 301-
496-9839.
FOR FURTHER INFORMATION CONTACT: Suzanne Goodwin, NIH Office of
Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD
20892, 301-496-9838, goodwins@od.nih.gov.
SUPPLEMENTARY INFORMATION: The Department of Health and Human Services
(HHS) established SACGHS to serve as a public forum for deliberations
on the broad range of human health and societal issues raised by the
development and use of genetic technologies and, as warranted, to
provide advice on these issues. For more information about the
Committee, please visit its Web site: https://www4.od.nih.gov/oba/
sacghs.htm.
In its first year, SACHGS identified coverage and reimbursement of
genetic tests and services as a high priority because there are
significant barriers to coverage and reimbursement as well as unmet
data needs that are currently limiting appropriate access and clinical
integration.
Its report, Coverage and Reimbursement of Genetic Tests and
Services, describes the current state of, and problems associated with,
coverage and reimbursement for genetic tests and services and offers
recommendations on how current mechanisms for coverage and
reimbursement for genetic tests and services might be improved. Once
finalized, the report and recommendations will be transmitted to the
Secretary of Health and Human Services.
SACGHS proposing to make the following recommendations in its
report to the Secretary:
1. The Secretary should task an appropriate group or body to
develop a set of principles to guide coverage decision making for
genetic tests. The principles should identify criteria to help
determine which types or categories of genetic tests should be covered,
which should not be covered, and which fall into an uncertain gray
zone. The group's guiding principles should address the issues of
economic evaluation/cost-effectiveness, prevention, rare disease tests,
and therapeutic versus informational benefit. The Committee also
recommends that the existing evidence for specific tests be assessed in
order to determine whether the evidence is adequate in type, quality,
and quantity to establish analytical validity, clinical validity and
clinical utility as well as to identify any gaps in evidence.
This body should include both relevant HHS agencies and private
organizations and utilize resources of models in the public and private
sector. The Evaluation of Genomic Applications in Practice and
Prevention Work Group organized by the Centers for Disease Control and
Prevention involves such a diverse range of stakeholders and is
performing similar work and, thus, is an example of such a body to be
tasked to develop these principles and address these issues.
The Committee also recommends a mechanism be established that would
specifically promote and fund studies to address any identified gaps in
the evidence base.
2. Genetic tests and services in pediatrics and those with a
prevention component should be considered specifically with respect to
the benefits they can offer the populations they serve. Although
standardization of coverage decisions using best scientific evidence
across public and private payers is ideal (see Recommendation 1),
private payers should be supported with necessary information to make
their own coverage determinations about these tests and services
relative to the populations they serve.
3. Although a mixed national-local coverage decision-making process
is a reasonable approach to making Medicare coverage decision for
genetic tests and services, there are several aspects of the current
national-local decision-making process that limit its utility. While
not suggesting changes to the current system, SACGHS recommends that
the Secretary encourage the Centers for Medicare & Medicaid Services
(CMS) to move forward with the implementation of Section 731 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003,
which requires the development of a plan to evaluate new local coverage
decisions to determine which should be adopted nationally and to what
extent greater consistency in Medicare coverage policy can be achieved.
4. Medicare beneficiaries who lack current signs, symptoms, or
personal histories of illness stand to clinically benefit from
predictive and predispositional genetic tests and services. As such,
SACGHS recommends that preventive services, including predispositional
genetic tests and services, meeting evidence standards should be
covered under Medicare.
The Secretary should urge Congress to add a benefit category for
preventive services that would enable CMS to determine through its
national coverage decision-making process, which includes an assessment
of existing evidence, whether an item or service is reasonable and
necessary for the prevention or early detection of an illness or
disability and, thus, ought to be covered. Such action would allow CMS
to consider covering many more genetic tests and services that are used
for preventive purposes.
More immediately, the Secretary should direct CMS to clarify,
through appropriate guidance, that in certain circumstances and where
scientific evidence warrants, ``personal history'' may include family
history of a particular disease for purposes of establishing that a
genetic test is ``reasonable and necessary'' and, therefore, covered
under Medicare. CMS should specify the circumstances and criteria
required to make such a determination.
5. The Secretary should broadly disseminate to all states
information about the existing evidence base and other supporting
information, such as guiding principles that serve as the basis for
coverage decision-making, on genetic tests and services. This
information could be utilized by the
[[Page 17086]]
states to inform their Medicaid coverage decisions.
HHS should continue to provide states with grants that encourage
the coverage, adoption and provision of genetic services that have a
sound evidence base.
6. In many cases, payment rates for genetic tests are lower than
the actual cost of performing the test. Until the fee schedule can be
reconsidered in a comprehensive way, the Secretary should direct CMS to
address variations in payment rates for the genetic test Current
Procedural Terminology (CPT) codes through its inherent reasonableness
authority.
7. Genetic counseling is a critically important component of the
appropriate use and integration of genetic tests and services. As such,
SACGHS recommends the following:
Qualified health providers should be allowed to bill
directly for genetic counseling services. The Secretary should
expeditiously identify an appropriate mechanism for determining the
credentials and criteria needed for a health provider to be deemed
qualified to provide genetic counseling services and eligible to bill
directly for them.
The Secretary should direct government programs to
reimburse prolonged service codes when determined to be reasonable and
necessary.
HHS, with input from the various providers of genetic
counseling services, should assess the adequacy of existing CPT
Evaluation & Management (E&M) codes and their associated relative
values with respect to genetic counseling services. Any inadequacies
identified should be addressed as deemed appropriate.
CMS should deem all non-physician health providers who are
currently permitted to bill directly any health plan--public or
private--eligible for a National Provider Identifier.
The Secretary should direct CMS to allow non-physician
health professionals who are qualified to provide genetic counseling
services and who currently bill incident to a physician to utilize the
full range of CPT E&M codes available for genetic counseling services.
8. Since providers act as intermediaries between health plans and
plan members and thus have an important role in ensuring genetic tests
and services are provided appropriately, there is a need to support the
ongoing training and continued education of health providers in
genetics and genomics. SACGHS's recommendations to the Secretary in
2004 included the following: the Secretary should develop a plan for
HHS agencies to work collaboratively with state, federal and private
organizations to support the development, cataloguing and dissemination
of case studies and practice models that demonstrate the current
relevance of genetics and genomics; and the Secretary should strive to
incorporate genetics and genomics into relevant initiatives of HHS,
including the National Health Information Infrastructure.
9. Reliable and trustworthy information about family history,
genetics and genetic technologies should be developed and made more
widely available through the internet and other mechanisms that allow
patients and consumers to evaluate health plan benefits and health
providers so that they may make the most appropriate and most
financially responsible decisions for themselves and their families.
The Secretary should leverage HHS resources to develop and make
widely available reliable and trustworthy information about genetics
and genetic technologies to guide and promote informed decision making
by healthcare consumers and providers. Such information should be made
available though federal government Web sites and other appropriate
mechanisms.
The full report is available electronically at https://
www4.od.nih.gov/oba/sacghs/public_comments.htm. A paper or electronic
copy also can be requested by calling the NIH Office of Biotechnology
Activities at 301-496-9838- or by e-mailing Suzanne Goodwin at
goodwins@od.nih.gov.
SACGHS is requesting comments on these recommendations and the
overall content of the draft report. Public comments received by May 6,
2005, will be considered by SACGHS in preparing the final report. The
report and the public comments will be discussed at SACGHS's next
meeting on June 15-16, 2005, in Bethesda, MD. Comments also will be
available for public inspection at the NIH Office of Biotechnology
Activities Monday through Friday between the hours of 8:30 a.m. and 5
p.m.
Dated: March 28, 2005.
Anna Snouffer,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 05-6614 Filed 4-1-05; 8:45 am]
BILLING CODE 4140-01-M
