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[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>
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