Genomics and Personalized Medicine Act of 2007 - Directs the Secretary of Health and Human Services to: (1) establish the Genomics and Personalized Medicine Interagency Working Group (IWG) to facilitate collaboration, coordination, and integration of activities among federal agencies relating to genomic research and initiatives; (2) establish a national biobanking distributed database for the collection and integration of genomic data and associated environmental and clinical health information; (3) establish a grant program for academic medical centers and other entities to develop or expand biobanking initiatives; (4) improve genetics and genomics training for diagnosis, treatment, and counseling of adults and children for both rare and common disorders; (5) contract with the National Academy of Sciences to study incentives to encourage companion diagnostic test development; and (6) make information available on the safety and efficacy of genetic tests and commission a study for improving federal oversight and regulation of such tests.
Requires the Director of the Centers for Disease Control and Prevention to: (1) conduct an analysis of the public health impact of direct-to-consumer marketing of genetic tests; and (2) expand efforts to educate the public about genomics and its health applications.
[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 976 Introduced in Senate (IS)]
110th CONGRESS
1st Session
S. 976
To secure the promise of personalized medicine for all Americans by
expanding and accelerating genomics research and initiatives to improve
the accuracy of disease diagnosis, increase the safety of drugs, and
identify novel treatments.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 23, 2007
Mr. Obama (for himself and Mr. Burr) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To secure the promise of personalized medicine for all Americans by
expanding and accelerating genomics research and initiatives to improve
the accuracy of disease diagnosis, increase the safety of drugs, and
identify novel treatments.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Genomics and Personalized Medicine
Act of 2007''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) The completion of the Human Genome Project in 2003
paved the way for a more sophisticated understanding of
diseases and drug responses, which has contributed to the
advent of ``personalized medicine''.
(2) Personalized medicine is the application of genomic and
molecular data to better target the delivery of health care,
facilitate the discovery and clinical testing of new products,
and help determine a person's predisposition to a particular
disease or condition.
(3) Many commonly-used drugs are typically effective in
only 40 to 60 percent of the patient population.
(4) In the United States, up to 15 percent of hospitalized
patients experience a serious adverse drug reaction, and more
than 100,000 deaths are attributed annually to such reactions.
(5) Pharmacogenomics has the potential to dramatically
increase the efficacy and safety of drugs and reduce health
care costs, and is fundamental to the practice of genome-based
personalized medicine.
(6) Pharmacogenomics is the study of how genetic variation
affects a person's response to drugs. This relatively new field
combines pharmacology (the science of drugs) and genomics (the
study of genes and their functions) to develop safer and more
effective medications and dosing regimens that will be tailored
to an individual's genetic makeup.
(7) The cancer drug Gleevec was developed based on
knowledge of the chromosomal translocation that causes chronic
myelogenous leukemia, which is characterized by an abnormal
growth in the number of white blood cells. The mean 5-year
survival for affected patients who are treated with Gleevec is
95 percent, which contrasts to a 5-year survival of 50 percent
for patients treated with older therapies.
(8) The ERBB2 gene helps cells grow, divide and repair
themselves. One in 4 breast cancers are characterized by extra
copies of this gene, which causes uncontrolled and rapid tumor
growth. Pharmacogenomics research led to both the development
of the test for this type of breast cancer as well as an
effective biologic, Herceptin.
(9) Warfarin, a blood thinner used to prevent the formation
of life-threatening clots, significantly elevates patient risk
for bleeding in the head or gastrointestinal tract, both of
which are associated with increased rates of hospitalization,
disability and death. Pharmacogenomic researchers have
identified and developed tests for genetic variants in the
cytochrome P450 metabolizing enzyme (CYP2C9) and vitamin K
epoxide reductase complex that increase risk for these adverse
events. By using a companion diagnostic test for these two
genes, physicians can modify the dosing regimen and decrease
the likelihood of adverse events.
(10) Although the cancer drug 6-mercaptopurine (6-MP) cures
85 percent of children with acute lymphoblastic leukemia,
historically, a significant number of patients would die
inexplicably from the drug. Researchers later discovered that 1
in 300 individuals inherit an inactive version of the gene
encoding the metabolizing enzyme thiopurine methyltransferase
(TPMT) from both their mother and father and, as a result,
should receive only a fraction of the standard dose of purine
drugs. In addition, 1 in 10 individuals have only 1 copy of the
gene with variable function, and the dosage of 6-MP must be
adjusted for a subset of these patients. Physicians now are
able to screen for TPMT gene variants before administering
these drugs.
(11) Research into the genetics of breast cancer identified
two pivotal genes, BRCA1 and BRCA2, mutations in which
correspond to a significantly increased lifetime risk of
developing breast and ovarian cancer. Individuals in affected
families or with specific risk factors may use genetic testing
to identify whether they carry mutations in these genes and to
inform their decisions about treatment options, including
prophylatic mastectomy and oophorectomy.
(12) Realizing the promise of personalized medicine will
require continued Federal leadership and agency collaboration,
expansion and acceleration of genomics research, a capable
genomics workforce, incentives to encourage development and
collection of data on the analytic and clinical validity and
clinical utility of genomic tests and therapies, and improved
regulation over the quality of genetic tests, direct-to-
consumer advertising of genetic tests, and use of personal
genomic information.
SEC. 3. DEFINITIONS.
In this Act:
(1) Biobank.--The term ``biobank'' means a shared
repository of human biological specimens that may also include
data associated with such specimens collected for medical or
research purposes. Human biological specimens may include body
fluids, tissues, blood, cells, or materials derived from these
sources, and data associated with such specimens may include
health information or environmental data.
(2) Biomarker.--The term ``biomarker'' means an analyte
found in or derived from a patient specimen that is objectively
measured and evaluated as an indicator of normal biologic
processes, pathogenic processes, or pharmacologic responses to
a therapeutic intervention.
(3) CLIA.--The term ``CLIA'' means the Clinical Laboratory
Improvement Amendments of 1988 (42 U.S.C. 263a).
(4) Environment.--The term ``environment'' means conditions
or circumstances that are nongenetic but may have a health
impact.
(5) Genetic test.--The term ``genetic test'' means an
analysis of human DNA, RNA, chromosomes, proteins, or
metabolites, that detects genotypes, mutations, or chromosomal
and biochemical changes.
(6) Laboratory-developed genetic test.--The term
``laboratory-developed genetic test'' means a genetic test that
is designed, validated, conducted, and offered as a service by
a clinical laboratory subject to CLIA using either commercially
available analyte specific reagents (FDA-regulated) or reagents
prepared by the laboratory (not FDA-regulated), or some
combination thereof.
(7) Pharmacogenetic test.--The term ``pharmacogenetic
test'' means a genetic test intended to identify individual
variations in DNA sequence related to drug absorption and
disposition (pharmacokinetics) or drug action
(pharmacodynamics), including polymorphic variation in the
genes that encode the functions of transporters, receptors,
metabolizing enzymes, and other proteins.
(8) Pharmacogenomic test.--
(A) In general.--The term ``pharmacogenomic test''
means a genetic test intended to identify individual
variations in single-nucleotide polymorphisms,
haplotype markers, or alterations in gene expression or
inactivation, that may be correlated with
pharmacological function and therapeutic response.
(B) Variations and alterations.--For purposes of
this paragraph, the variations or alterations referred
to in subparagraph (A) may be a pattern or profile of
change, rather than a change in an individual marker.
(9) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
SEC. 4. GENOMICS AND PERSONALIZED MEDICINE INTERAGENCY WORKING GROUP.
(a) In General.--Not later than 90 days after the date of enactment
of this Act, the Secretary shall establish within the Department of
Health and Human Services the Genomics and Personalized Medicine
Interagency Working Group (referred to in this Act as the ``IWG'').
(b) Duties.--The IWG shall facilitate collaboration, coordination,
and integration of activities within the Department of Health and Human
Services and other Federal agencies, and among such agencies and
relevant public and private entities, by--
(1) reviewing current and proposed genomic initiatives, in
order to identify shared interests and leverage resources;
(2) prioritizing new genomic initiatives, based on areas of
need as measured by public health impact;
(3) reaching consensus on standardized genomic terminology,
definitions, and data code sets for adoption and use in
Federally conducted or supported programs;
(4) establishing and disseminating quality standards and
guidelines for the collection, processing, archiving, storage,
and dissemination of genomic samples and data for research and
clinical purposes;
(5) developing and promulgating guidelines regarding
procedures, protocols, and policies for the safeguarding of the
privacy of biobank subjects, in accordance with the Office for
Human Research Protection and Clinical Research Policy Analysis
and Coordination Program at the National Institutes of Health,
and other guidelines as appropriate;
(6) reviewing and making recommendations to address
ownership and patient access issues with respect to genomic
samples and analyses;
(7) developing and promulgating guidelines regarding
procedures, protocols, and policies for access to patient data,
genomic samples, and associated health information by non-
governmental entities for research purposes;
(8) developing and disseminating guidelines for
constructing informed consent forms that ensure patient privacy
and confidentiality of associated clinical data and
information, understanding of research procedures, benefits,
risks, rights, and responsibilities, and continuous voluntary
participation; and
(9) providing recommendations for the establishment of a
distributed database, pursuant to section 5.
(c) IWG Chairperson.--The Secretary, or his or her designee, shall
serve as chairperson of the IWG.
(d) Members.--In addition to the Secretary, the IWG shall include
members from the--
(1) National Institutes of Health;
(2) Centers for Disease Control and Prevention;
(3) Food and Drug Administration;
(4) Health Resources and Services Administration;
(5) Office of Minority Health;
(6) Agency for Healthcare Research and Quality;
(7) Centers for Medicare & Medicaid Services;
(8) Veterans Health Administration;
(9) Office of the National Coordinator for Health
Information Technology;
(10) Department of Energy;
(11) Armed Forces Institute of Pathology;
(12) Indian Health Service; and
(13) other Federal departments and agencies as determined
appropriate by the Secretary.
(e) Public Input.--The IWG shall solicit input from relevant
stakeholders with respect to meeting the duties described in subsection
(b).
(f) Report.--Not later than 18 months after the date of enactment
of this Act, the Secretary shall prepare and submit a report to the
appropriate committees of Congress and to the public on IWG
deliberations, activities, and recommendations with respect to meeting
the duties described in subsection (b).
(g) Termination.--The IWG shall terminate after submitting the
report described in subsection (f), or later at the discretion of the
Secretary.
(h) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $1,000,000 for fiscal years
2008 and 2009.
SEC. 5. NATIONAL BIOBANKING INITIATIVE.
(a) In General.--The Secretary shall advance the field of genomics
and personalized medicine through establishment of a national
biobanking distributed database for the collection and integration of
genomic data, and associated environmental and clinical health
information, which shall facilitate synthesis and pooled analysis of
such data.
(b) Database.--With respect to the national biobanking distributed
database, the Secretary shall--
(1) adhere to relevant guidelines, policies, and
recommendations of the IWG, pursuant to section 4;
(2) establish, directly or by contract, a single point of
authority to manage operations of the database;
(3) incorporate biobanking data from Federally conducted or
supported genomics initiatives, as feasible;
(4) encourage voluntary submission of biobanking data
obtained or analyzed with private or non-Federal funds;
(5) facilitate submission of data, including secure and
efficient electronic submission;
(6) allow public use of data only--
(A) with appropriate privacy safeguards in place;
and
(B) for health research purposes;
(7) determine appropriate procedures for access by
nongovernmental entities to biobank data for research and
development of new or improved tests and treatments, and
submission of data generated from such samples to the Food and
Drug Administration as part of the approval process for drugs
and devices;
(8) conduct, directly or by contract, analytical research,
including clinical, epidemiological, and social research, using
biobank data; and
(9) make analytic findings from biobanking initiatives
supported by Federal funding publicly available within an
appropriate timeframe to be determined by the Secretary.
(c) Rule of Construction.--Nothing in this section shall be
construed to require the submission or acceptance of biological
specimens.
(d) Biobank Initiatives Grants.--
(1) In general.--The Secretary shall establish a grant
program for eligible entities to develop or expand biobanking
initiatives to increase understanding of how genomics interacts
with environmental factors to cause disease, and to accelerate
the development of genomic-based tests and treatments.
(2) Eligible entities.--
(A) In general.--For purposes of this subsection,
eligible entities include academic medical centers and
other entities determined appropriate by the Secretary.
Eligible entities desiring a grant under this
subsection shall submit an application to the Secretary
in accordance with this subsection, at such time, in
such manner, and containing such additional information
as the Secretary may require.
(B) Priority.--Academic medical centers that
partner with health care professionals within their
communities in order to obtain diverse genomic samples
shall be given priority for awards made under this
subsection.
(3) Requirements.--The Secretary shall ensure that biobanks
supported by grant awards under this section--
(A) adhere to guidelines and recommendations
developed pursuant to section 4;
(B) are established to complement activities
related to the implementation of current Federal
biobanking research initiatives, as feasible;
(C) are based on well-defined populations,
including population-based registries of disease and
family-based registries;
(D) collect data from participants with diverse
genomic profiles, demographics, environmental
exposures, and presence or absence of health conditions
and diseases, as appropriate;
(E) meet quality standards for the collection,
processing, archiving, storage, and dissemination of
data, which shall be developed by the IWG;
(F) have practical experience and demonstrated
expertise in genomics and its clinical and public
health applications;
(G) establish mechanisms to ensure patient privacy
and protection of information from non-health
applications and, as feasible, patient access to
genomic samples for clinical testing purposes; and
(H) contribute genomic and associated clinical and
environmental data and analyses to the national
biobanking distributed database, pursuant to subsection
(b).
(4) Use of funds.--An eligible entity that receives a grant
under this subsection shall use the grant funds to develop or
expand a biobanking initiative, which may include the following
activities:
(A) Support for scientific and community advisory
committees.
(B) Recruitment and education of participants.
(C) Development of consent protocols.
(D) Obtaining genetic samples and associated
environmental and clinical information.
(E) Establishment and maintenance of secure storage
for genetic samples and clinical information.
(F) Conduct of data analyses and evidence-based
systemic reviews that allow for the following:
(i) Identification of biomarkers and other
surrogate markers to improve predictions of
onset of disease, response to therapy, and
clinical outcomes.
(ii) Increased understanding of gene-
environment interactions.
(iii) Development of genetic screening,
diagnostic, and therapeutic interventions.
(iv) Genotypic characterization of tissue
samples.
(G) Other activities, as determined appropriate by
the Secretary.
(5) Quality assurance.--The Secretary may enter into a
contract with an external entity to evaluate grantees under
this subsection to ensure that quality standards are met.
(e) Application of Privacy Rules.--Nothing in this Act shall be
construed to supercede the requirements for the protection of patient
privacy under--
(1) the Federal regulations promulgated under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996 (42 U.S.C. 1320d-2 note); or
(2) sections 552 and 552a of title 5, United States Code (5
U.S.C. App.).
(f) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $75,000,000 for fiscal year
2009, and such sums as may be necessary for each of fiscal years 2010
through 2014.
SEC. 6. GENOMICS WORKFORCE AND TRAINING.
(a) Genetics and Genomics Training.--The Secretary, directly or
through contracts or grants to eligible entities, which shall include
professional genetics and genomics societies, academic institutions,
and other entities as determined appropriate by the Secretary, shall
improve the adequacy of genetics and genomics training for diagnosis,
treatment, and counseling of adults and children for both rare and
common disorders, through support of efforts to--
(1) develop and disseminate model training program and
residency curricula and teaching materials that reflect the new
knowledge and evolving practice of genetics and genomics;
(2) assist the review of board and other certifying
examinations by professional societies and accreditation bodies
to ensure adequate focus on the fundamental principles of
genomics; and
(3) identify and evaluate options for distance or on-line
learning for degree or continuing education programs.
(b) Integration.--The Secretary, in collaboration with medical
professional societies and accreditation bodies and associations of
health professional schools, shall support initiatives to increase the
integration of genetics and genomics into all aspects of clinical and
public health practice by promoting genetics and genomics competency
across all clinical, public health, and laboratory disciplines through
the development and dissemination of health professional guidelines
which shall--
(1) include focus on appropriate techniques for collection
and storage of genomics samples, administration and
interpretation of genetic and genomic tests, and subsequent
clinical and public health decisionmaking; and
(2) specifically target health professionals without formal
training or experience in the field of genomics.
(c) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $5,000,000 for fiscal year 2008
and such sums as may be necessary for each of fiscal years 2009 through
2013.
SEC. 7. REALIZING THE POTENTIAL OF PERSONALIZED MEDICINE.
(a) National Academy of Sciences Study.--Not later than 180 days
after the date of enactment of this Act, the Secretary shall enter into
a contract with the National Research Council of the National Academy
of Sciences to study and recommend appropriate incentives to
encourage--
(1) codevelopment of companion diagnostic testing by a drug
sponsor;
(2) development of companion diagnostic testing for
already-approved drugs by the drug sponsor;
(3) companion diagnostic test development by device
companies that are not affiliated with the drug sponsor; and
(4) action on other issues determined appropriate by the
Secretary.
(b) Genetic Test Quality.--
(1) In general.--The Secretary shall improve the
availability of information on, and safety and efficacy of,
genetic tests, including pharmacogenetic and pharmacogenomic
tests.
(2) Institute of medicine study.--Not later than 30 days
after the date of enactment of this Act, the Secretary shall
enter into a contract with the Institute of Medicine to conduct
a study and prepare a report that includes recommendations to
improve Federal oversight and regulation of genetic tests, with
specific recommendations on the implementation of the decision
matrix under paragraph (3). Such study shall take into
consideration relevant reports by the Secretary's Advisory
Committee on Genetic Testing and other groups and shall be
completed not later than 1 year after the date on which the
Secretary entered into such contract.
(3) Decision matrix.--
(A) In general.--Not later than 18 months after the
date of enactment of this Act, the Secretary, taking
into consideration the recommendations of the Institute
of Medicine report under paragraph (2), shall implement
a decision matrix (referred to in this section as the
``matrix'') to improve the oversight and regulation of
genetic tests, including pharmacogenomic and
pharmacogenetic tests by determining--
(i) the classification of all genetic
tests;
(ii) which categories of tests, including
laboratory-developed tests, require review and
the level of review needed for such categories
of tests;
(iii) which agency shall have oversight
over the review process of such categories of
tests that are determined to require review;
and
(iv) to the extent practicable, which
requirements the agency shall apply to the
types of tests identified in clause (ii).
(B) Level of review.--In determining the level of
review needed by a genetic test, the Secretary shall
take into consideration--
(i) performance characteristics of the test
and its target disease or condition;
(ii) intended use of the test;
(iii) potential for improved medical
conditions and patient harms; and
(iv) social consequences of the test.
(C) Comparative analysis.--To inform implementation
of the matrix, the Secretary shall undertake a
comparative analysis of laboratory review requirements
under CLIA and those of the Food and Drug
Administration to--
(i) assess and reduce unnecessary
differences in such requirements;
(ii) eliminate redundancies and decrease
burden of review, as practicable; and
(iii) specify which elements of the test
constitute a device that may be regulated by
the Food and Drug Administration and which
elements comprise a service that may be
regulated under CLIA.
(D) Regulations.--The Secretary shall promulgate
regulations to implement the matrix not later than the
date specified under subparagraph (A).
(E) Transition period.--The Secretary may not
require a laboratory to submit a report under section
510(k) or an application under section 515 of the
Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et
seq.) until 180 days after the regulations promulgated
under subparagraph (D) take effect.
(4) Adverse events.--The Secretary, acting through the
Commissioner of Food and Drugs and the Administrator of the
Centers for Medicare & Medicaid Services, shall--
(A) develop or expand adverse event reporting
systems to encompass reports of adverse events
resulting from genetic testing;
(B) respond appropriately to any adverse events
resulting from such testing; and
(C) facilitate the use of genetic and genomic
approaches, as feasible, to assess risk for, and reduce
incidence of, adverse drug reactions.
(5) Authorization of appropriations.--There are authorized
to be appropriated to carry out this subsection, $6,000,000 for
fiscal year 2008, and such sums as may be necessary for each of
fiscal years 2009 through 2013.
(c) Food and Drug Administration.--
(1) In general.--
(A) Summary information.--If a genetic test that is
determined to be within the jurisdiction of the Food
and Drug Administration but that does not require
review as determined under the matrix, the sponsor of
such test shall provide the Secretary with summary
information on how such test was validated and its
performance characteristics. Such information shall be
in a standardized format and with standardized content
as specified by the Food and Drug Administration, and
shall be made easily accessible to the public.
(B) Source of information.--The information
described under subparagraph (A) may be obtained from
the labeling submitted for CLIA complexity
categorization.
(2) Encouragement of companion diagnostic testing.--The
Secretary may encourage the sponsor of a drug or biological
product--
(A) to codevelop a companion diagnostic test, after
filing an investigational new drug application or a new
drug application to address significant safety concerns
of the drug or biological product;
(B) to develop a companion diagnostic test if phase
IV data demonstrate significant safety or effectiveness
concerns with use of the drug or biological product;
and
(C) to relabel the drug or biological product to
require validated companion diagnostic testing when
evidence of improved outcomes has been established in
practice or if data demonstrate significant safety
concerns with use of such drug or biological product.
(3) Pharmacogenomic data submission.--The Secretary shall
encourage and facilitate voluntary pharmacogenomic data
submission from drug sponsors, which may include--
(A) the development and dissemination of guidance
on relevant policies, procedure and practice regarding
such submission;
(B) the provision of technical assistance;
(C) the establishment of a mechanism to store,
maintain and analyze such data, in collaboration with
the National Institutes of Health and the Centers for
Disease Control and Prevention;
(D) determining when such data may be used to
support an investigational new drug or a new drug
application;
(E) the conduct of a study of the use of genomic
approaches to understand and reduce adverse drug
reactions; and
(F) other activities determined appropriate by the
Commissioner.
(4) Termination of certain advertising campaigns.--The Food
and Drug Administration shall collaborate with the Federal
Trade Commission to identify and terminate, pursuant to section
5 of the Federal Trade Commission Act (15 U.S.C. 45),
advertising campaigns that make false, misleading, deceptive,
or unfair claims about the benefits or risks of genetic tests.
(d) Centers for Medicare & Medicaid Services.--
(1) In general.--If a genetic test that is determined to be
within the jurisdiction of the Centers for Medicare & Medicaid
Services but that does not require review as determined under
the matrix, the sponsor of such test shall provide the
Administrator of the Centers for Medicare & Medicaid Services
with summary information on how the test was validated and its
performance characteristics. Such information shall be in a
standardized format and with standardized content as specified
by the Centers for Medicare & Medicaid Services, and shall be
made easily accessible to the public.
(2) Specialty area.--To ensure the accuracy, validity, and
reliability of clinical genetic tests that do not require
premarket approval by or notification to the Food and Drug
Administration, and to improve oversight of genetic test
laboratories, the Director of the Division of Laboratory
Services of the Survey and Certification Group of the Center
for Medicaid and State Operations of the Centers for Medicare &
Medicaid Services, in collaboration with the Clinical
Laboratory Improvement Advisory Committee at the Centers for
Disease Control and Prevention, shall establish a specialty
area for molecular and biochemical genetic tests, in order to--
(A) develop criteria for establishing analytic and
clinical validity for genetic tests that are determined
to require review under the matrix;
(B) specify requirements for proficiency testing
for laboratories;
(C) provide guidance regarding the scope of duty
for laboratory directors;
(D) make information easily accessible to the
public about--
(i) laboratory certification; and
(ii) analytic and clinical validity for
genetic tests that are determined to require
high level review under the matrix; and
(E) conduct other activities at the discretion of
the Administrator of the Centers for Medicare &
Medicaid Services.
(3) Reimbursement.--
(A) Coding.--To foster adoption of genetic
screening tools, the Administrator of the Centers for
Medicare & Medicaid Services shall--
(i) assess and update current procedure
terminology codes to encourage the rapid review
and coverage of novel tests through the
creation of new HCPCS codes and adoption of new
CPT codes and without undue reliance on
national coverage determinations; and
(ii) determine and implement fair and
reasonable coverage policies and reimbursement
rates for medically necessary genetic and
genomic treatments and services, including
laboratory testing.
(B) Budget neutrality.--Before enhancing payment
for a year pursuant to this paragraph, the Secretary
shall, if necessary, provide for an adjustment to
payments made under part B of title XVIII of the Social
Security Act (42 U.S.C. 1395j et seq.) in that year to
ensure that such payments shall be equal to aggregate
payments that would have been made under such part in
that year if this paragraph had not been enacted.
(e) Centers for Disease Control and Prevention.--
(1) Direct-to-consumer marketing.--Not later than 2 years
after the date of enactment of this Act, the Director of the
Centers for Disease Control and Prevention, with respect to
genetic tests for which consumers have direct access, shall--
(A) conduct an analysis of the public health impact
of direct-to-consumer marketing to the extent possible
from available data sources;
(B) analyze the validity of claims made in direct-
to-consumer marketing to determine whether such claims
are substantiated by competent and reliable scientific
evidence; and
(C) make recommendations to the Secretary regarding
necessary interventions to protect the public from
potential harms of direct-to-consumer marketing and
access to genetic tests.
(2) Public awareness.--The Director shall expand efforts to
educate and increase awareness of the general public about
genomics and its applications to improve health, prevent
disease and eliminate health disparities. Such efforts shall
include the--
(A) ongoing collection of data on the awareness,
knowledge and use of genetic tests through public
health surveillance systems, and analysis of the impact
of such tests on population health; and
(B) integration of the use of validated genetic and
genomic tests in public health programs as appropriate.
(3) Authorization of appropriations.--There are authorized
to be appropriated to carry out this subsection, $10,000,000
for fiscal year 2008, and such sums as may be necessary for
each of fiscal years 2009 through 2013.
(f) Agency for Healthcare Research and Quality.--The Director of
the Agency for Healthcare Research and Quality, after consultation with
the IWG and other public and private organizations based in the United
States and abroad, as appropriate, shall support the assessment of the
clinical utility and cost-effectiveness of companion diagnostic tests
that guide prescribing decisions, through research that--
(1) develops standardized tools and methodologies to assess
the clinical utility and cost-effectiveness of such tests, as
well as criteria for use;
(2) establishes and validates drug dosing algorithms for
which such tests can improve outcomes, taking into
consideration--
(A) a reduction in toxicity, adverse events, and
mortality;
(B) improved clinical outcomes and quality of life,
including decreased requirements for monitoring and
laboratory testing; and
(C) the impact on the direct and indirect costs of
health care, which may include costs due to length of
hospital stay, length of time to identify safe and
effective dosing for patients, toxicity and adverse
events, and other measures of health care utilization
and outcomes;
(3) supports and expedites the development of clinical
decision tools for clinical use of genetic tests, as warranted;
and
(4) prioritizes the development of such tests for diseases
and health conditions that have a significant public health
impact because of prevalence, risk of complications from
treatment, and other factors determined appropriate by the
Director.
(g) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $10,000,000 for fiscal year
2008, and such sums as may be necessary for each of fiscal years 2009
through 2013.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S3708-3710)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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