Top Legislation - View All

Latest Action: 09/26/2008 - Received in the Senate.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. 9/25/2008--Passed House amended.    (There is 1 other summary) Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary of Health and Human Services to deny a new drug application if the application fails to include required information on clinical investigations.Directs the Secretary to require that a new drug application include any clinical data possessed by the applicant that relates to the safety and effectiveness of the drug involved by gender, age, and racial subgroup. (Currently, this is required by regulation.)Requires the Secretary to develop guidance for the staff of the Food and Drug Administration (FDA) [...]

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Latest Action: 10/02/2007 - Sponsor introductory remarks on measure. (CR H11153)

Bill Text
To amend titles XI and XVIII of the Social Security Act to modernize the quality improvement organization (QIO) program. 2/14/2007--Introduced. Medicare Quality Improvement Organization Modernization Act of 2007 - Amends title XI of the Social Security Act (SSA) to require utilization and quality control peer review organizations to offer quality improvement assistance to providers, practitioners, Medicare Advantage organizations under part C (Medicare+Choice) of title XVIII (Medicare), and prescription drug sponsors under part D (Voluntary Prescription Drug Benefit Program) of such title. Requires the organization to establish a Medicare quality accountability program. Revises requirements for the quality improvement program (QIO), including program administration, data disclosure, use of evaluation and competition, quality improvement funding, and qualifications for QIOs under part B (Peer Review) of SSA title XI. Amends SSA title XIX (Medicaid) [...]

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Latest Action: 04/20/2007 - Referred to the Subcommittee on Health.

Bill Text
To improve vaccine safety research, and for other purposes. 4/19/2007--Introduced. Vaccine Safety and Public Confidence Assurance Act of 2007 - Amends the Public Health Service Act to establish the Agency for Vaccine Safety Evaluation in the Office of the Secretary of Health and Human Services. Requires the Director for Vaccine Safety Evaluation to: (1) conduct or support safety research and monitor licensed vaccines; (2) develop a vaccine safety research agenda; (3) evaluate means to promote compliance with federal adverse reaction reporting requirements; (4) provide a clearinghouse for vaccine studies; (5) ensure that functions relating to vaccine monitoring or research on adverse reactions are not carried out by anyone with a conflict of interest; (6) oversee the Vaccine Safety Datalink Project; and (7) resolve U.S. conflicts of interest related to international agreements, partnerships, and activities. Allows the Director to establish a program of awarding fellowships [...]

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Latest Action: 08/02/2007 - Sponsor introductory remarks on measure. (CR S10798-10799)

Bill Text
A bill to amend title XI of the Social Security Act to improve the quality improvement organization (QIO) program. 8/2/2007--Introduced. Continuing the Advancement of Quality Improvement Act of 2007 - Amends title XI of the Social Security Act to require any utilization and quality control peer review organization (also known as a Quality Improvement Organization (QIO)) entering into a contract with the Secretary of Health and Human Services (HHS) to perform only the function of providing technical assistance for quality improvement and performance measurement to providers, practitioners, and Medicare Advantage organizations offering Medicare Advantage plans under part C (Medicare+Choice) of title XVIII.Directs the Secretary to develop and implement a transition plan for the transfer to Medicare provider review organizations (MPROs) of all other current functions of QIOs.Specifies requirements for an MPRO with responsibility for addressing beneficiary complaints.[...]

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Latest Action: 05/24/2007 - Received in the Senate and Read twice and referred to the Committee on Veterans' Affairs.

Bill Text
To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to provide certain improvements in the treatment of individuals with traumatic brain injuries, and for other purposes. 5/23/2007--Passed House amended.    (There is 1 other summary) Traumatic Brain Injury Health Enhancement and Long-Term Support Act of 2007 - (Sec. 2) Directs the Secretary of Veterans Affairs to establish a program to screen veterans eligible for Department of Veterans Affairs (VA) hospital, medical, and nursing home care for symptoms of traumatic brain injury (TBI). Requires the Secretary to develop and carry out a program of long-term care for post-acute TBI rehabilitation in four geographically dispersed polytrauma network sites designated by the Secretary. Makes eligible for such program veterans who: (1) served on active duty in a theater of combat operations during a period of war after the Persian Gulf War or during a period of hostilities [...]

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Latest Action: 07/24/2007 - Referred to the Subcommittee on Health, Employment, Labor, and Pensions.

Bill Text
To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group and individual health insurance coverage and group health plans to provide coverage for individuals participating in approved cancer clinical trials. 6/12/2007--Introduced. Access to Cancer Clinical Trials Act of 2007 - Amends the Public Health Service Act, the Employee Retirement Income Security Act of 1974 (ERISA), and the Internal Revenue Code to prohibit a group health plan from: (1) denying an eligible participant or beneficiary participation in clinical trials related to the treatment of cancer that are federally funded or conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); (2) denying (or limiting or imposing additional conditions on) the coverage of routine patient costs for items and services furnished in connection with such participation; or (3) discriminating against [...]

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Latest Action: 02/13/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Bill Text
A bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. 2/13/2007--Introduced. Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require an application for approval or for investigation of a drug, device, or biological product to include information stratified by sex, race, and ethnicity, including any differences in safety and effectiveness. Requires the Secretary of Health and Human Services to: (1) withhold approval of such an application or place a clinical hold on an investigation if such information is not included; and (2) report to the scientific community and make information available to the public on such stratified data upon approval of an application.Requires the Comptroller [...]

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Latest Action: 07/20/2007 - Referred to the Subcommittee on Health.

Bill Text
To amend title XVIII of the Social Security Act to ensure and foster continued patient quality of care by establishing facility and patient criteria for long-term care hospitals and related improvements under the Medicare Program. 7/17/2007--Introduced. Medicare Long-Term Care Patient Safety and Improvement Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to define "long-term care hospital" and establish new patient criteria for long-term care hospital prospective payments. Requires the Secretary of Health and Human Services to approve under Medicare distinct part inpatient rehabilitation hospital units in long-term care hospitals, if rehabilitation services are not included within a major diagnostic category. Directs the Secretary to: (1) report to the appropriate congressional committees recommendations on the promulgation of national long-term care hospital facility and patient criteria; and (2), after rulemaking, implement [...]

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Latest Action: 09/27/2007 - Signed by President.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 9/27/2007--Public Law.    (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential [...]

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Latest Action: 11/16/2007 - Sponsor introductory remarks on measure. (CR S14642-14643)

Bill Text
A bill to amend title XI of the Social Security Act to modernize the quality improvement organization (QIO) program. 11/16/2007--Introduced. Medicare Quality Improvement Organization Modernization Act of 2007 - Amends title XI of the Social Security Act (SSA) to require utilization and quality control peer review organizations to offer quality improvement assistance to providers, practitioners who provide health care items and services to individuals dually eligible for benefits under SSA titles XVIII (Medicare) and XIX (Medicaid), and programs that provide items and services to such individuals. Requires the organization to establish a Medicare quality accountability program. Directs the Secretary of Health and Human Services, acting through the Inspector General of the Department of Health and Human Services, to contract with an entity to conduct a medical review audit to evaluate whether quality improvement organizations are making appropriate noncompliance [...]

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Latest Legislation - View All

Latest Action: 06/05/2008 - Read twice and referred to the Committee on Finance.

Bill Text
A bill to amend title XVIII of the Social Security Act to exempt negative pressure wound therapy pumps and related supplies and accessories from the Medicare competitive acquisition program until the clinical comparability of such products can be validated.

6/5/2008--Introduced.

Medicare Wound Therapy Patient Protection Act of 2008 - Amends title XVIII (Medicare) of the Social Security Act to exempt from the Medicare competitive acquisition program negative pressure wound therapy pumps and related supplies and accessories, until the Secretary of Health and Human Services can validate, using a panel of wound care clinical experts, the clinical comparability of all such products.

Expresses the sense of the Senate that this Act should be deficit neutral over the five-year period beginning on October 1, 2008, through appropriate offsets.

Latest Action: 05/08/2008 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Bill Text
A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group and individual health insurance coverage and group health plans to provide coverage for individuals participating in approved cancer clinical trials. 5/8/2008--Introduced. Access to Cancer Clinical Trials Act of 2008 - Amends the Public Health Service Act, the Employee Retirement Income Security Act of 1974 (ERISA), and the Internal Revenue Code to prohibit a group health plan from: (1) denying an eligible participant or beneficiary participation in clinical trials related to the treatment of cancer that are federally funded or conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); (2) denying (or limiting or imposing additional conditions on) the coverage of routine patient costs for items and services furnished in connection with such participation; or (3) discriminating [...]

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Latest Action: 01/17/2008 - Referred to the Subcommittee on Health.

Bill Text
To amend title XVIII of the Social Security Act to exempt negative pressure wound therapy pumps and related supplies and accessories from the Medicare competitive acquisition program until the clinical comparability of such products can be validated.

1/15/2008--Introduced.

Medicare Wound Therapy Patient Protection Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to exempt from the Medicare competitive acquisition program negative pressure wound therapy pumps and related supplies and accessories, until the Secretary can validate, using a panel of wound care clinical experts, the clinical comparability of all such products.

Latest Action: 12/20/2007 - Referred to the Subcommittee on Health.

Bill Text
To amend title XVIII of the Social Security Act to exempt negative pressure wound therapy pumps and related supplies and accessories from the Medicare competitive acquisition program until the clinical comparability of such products can be validated.

12/18/2007--Introduced.

Medicare Wound Therapy Patient Protection Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to exempt from the Medicare competitive acquisition program negative pressure wound therapy pumps and related supplies and accessories, until the Secretary can validate, using a panel of wound care clinical experts, the clinical comparability of all such products.

Latest Action: 11/16/2007 - Sponsor introductory remarks on measure. (CR S14642-14643)

Bill Text
A bill to amend title XI of the Social Security Act to modernize the quality improvement organization (QIO) program. 11/16/2007--Introduced. Medicare Quality Improvement Organization Modernization Act of 2007 - Amends title XI of the Social Security Act (SSA) to require utilization and quality control peer review organizations to offer quality improvement assistance to providers, practitioners who provide health care items and services to individuals dually eligible for benefits under SSA titles XVIII (Medicare) and XIX (Medicaid), and programs that provide items and services to such individuals. Requires the organization to establish a Medicare quality accountability program. Directs the Secretary of Health and Human Services, acting through the Inspector General of the Department of Health and Human Services, to contract with an entity to conduct a medical review audit to evaluate whether quality improvement organizations are making appropriate noncompliance [...]

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Latest Action: 09/27/2007 - Signed by President.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 9/27/2007--Public Law.    (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential [...]

show full description
Latest Action: 08/02/2007 - Sponsor introductory remarks on measure. (CR S10798-10799)

Bill Text
A bill to amend title XI of the Social Security Act to improve the quality improvement organization (QIO) program. 8/2/2007--Introduced. Continuing the Advancement of Quality Improvement Act of 2007 - Amends title XI of the Social Security Act to require any utilization and quality control peer review organization (also known as a Quality Improvement Organization (QIO)) entering into a contract with the Secretary of Health and Human Services (HHS) to perform only the function of providing technical assistance for quality improvement and performance measurement to providers, practitioners, and Medicare Advantage organizations offering Medicare Advantage plans under part C (Medicare+Choice) of title XVIII.Directs the Secretary to develop and implement a transition plan for the transfer to Medicare provider review organizations (MPROs) of all other current functions of QIOs.Specifies requirements for an MPRO with responsibility for addressing beneficiary complaints.[...]

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Latest Action: 07/20/2007 - Referred to the Subcommittee on Health.

Bill Text
To amend title XVIII of the Social Security Act to ensure and foster continued patient quality of care by establishing facility and patient criteria for long-term care hospitals and related improvements under the Medicare Program. 7/17/2007--Introduced. Medicare Long-Term Care Patient Safety and Improvement Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to define "long-term care hospital" and establish new patient criteria for long-term care hospital prospective payments. Requires the Secretary of Health and Human Services to approve under Medicare distinct part inpatient rehabilitation hospital units in long-term care hospitals, if rehabilitation services are not included within a major diagnostic category. Directs the Secretary to: (1) report to the appropriate congressional committees recommendations on the promulgation of national long-term care hospital facility and patient criteria; and (2), after rulemaking, implement [...]

show full description
Latest Action: 07/24/2007 - Referred to the Subcommittee on Health, Employment, Labor, and Pensions.

Bill Text
To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group and individual health insurance coverage and group health plans to provide coverage for individuals participating in approved cancer clinical trials. 6/12/2007--Introduced. Access to Cancer Clinical Trials Act of 2007 - Amends the Public Health Service Act, the Employee Retirement Income Security Act of 1974 (ERISA), and the Internal Revenue Code to prohibit a group health plan from: (1) denying an eligible participant or beneficiary participation in clinical trials related to the treatment of cancer that are federally funded or conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); (2) denying (or limiting or imposing additional conditions on) the coverage of routine patient costs for items and services furnished in connection with such participation; or (3) discriminating against [...]

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Latest Action: 05/24/2007 - Received in the Senate and Read twice and referred to the Committee on Veterans' Affairs.

Bill Text
To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to provide certain improvements in the treatment of individuals with traumatic brain injuries, and for other purposes. 5/23/2007--Passed House amended.    (There is 1 other summary) Traumatic Brain Injury Health Enhancement and Long-Term Support Act of 2007 - (Sec. 2) Directs the Secretary of Veterans Affairs to establish a program to screen veterans eligible for Department of Veterans Affairs (VA) hospital, medical, and nursing home care for symptoms of traumatic brain injury (TBI). Requires the Secretary to develop and carry out a program of long-term care for post-acute TBI rehabilitation in four geographically dispersed polytrauma network sites designated by the Secretary. Makes eligible for such program veterans who: (1) served on active duty in a theater of combat operations during a period of war after the Persian Gulf War or during a period of hostilities [...]

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