Medical Devices Technical Corrections Act

Public Law 107-250: "Medical Device User Fee and Modernization Act of 2002" Implementation of legislation to amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes. PL 108-214, S. 1881, H.R. 3493: “Medical Devices Technical Corrections Act” Legislation to amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernization Act of 2002, and for other purposes. S. 16: “Protecting Americans Medical Privacy Act” Legislation to protect the civil rights of all Americans, and for other purposes. S. 720, H.R. 663: “Patient Safety and Quality Improvement Act” Legislation to amend title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely affect patient safety. S. 1450, H.R. 1177 Legislation to amend the Internal Revenue Code of 1986 to provide additional choice regarding unused health benefits in cafeteria plans and flexible spending arrangements. S. 1570: “Fair Care for the Uninsured Act of 2003” Legislation to amend the Internal Revenue Code of 1986 to allow individuals a refundable credit against income tax for the purchase of private health insurance, and to establish State health insurance safety-net programs. S. 1909, H.R. 3658: “Stroke Treatment and Ongoing Prevention Act” Legislation to amend the Public Health Service Act to strengthen education, prevention, and treatment programs relating to stroke, and for other purposes. S. 2003: “Health Information for Quality Improvement Act” Legislation to amend the Public Health Service Act to promote higher quality health care and better health by strengthening health information, information infrastructure, and the use of health information by providers and patients. S. 2163: “Small Employers Health Benefits Program Act of 2004” Legislation to establish a national health program administered by the Office of Personnel Management to offer health benefits plans to individuals who are not Federal employees, and for other purposes. S. 2421: “Health Care Modernization, Cost Reduction, and Quality Improvement Act” Legislation to modernize the health care system through the use of information technology and to reduce costs, improves quality, and provides a new focus on prevention with respect to health care. S. 2553, H.R. 4626: “Screening Abdominal Aortic Aneurysms Very Efficiently Act of 2004” Legislation to amend title XVIII of the Social Security Act to provide for coverage of screening ultrasound for abdominal aortic aneurysms under part B of the Medicare program. S. AMDT 2803: Legislation to provide $60 billion over five years for greater health security for working Americans and their families through a combination of public and private efforts to expand quality, affordable health insurance coverage and cut health care costs by eliminating certain tax loopholes. H.R. 815: “Aneurysm Awareness Act” Legislation to require the Secretary of Health and Human Services to conduct a study with respect to aneurysms, and for other purposes. H.R. 1709: “Stop Taking Our Health Privacy (STOHP) Act of 2003” Legislation to restore standards to protect the privacy of individually identifiable health information that were weakened by the August 2002 modifications, and for other purposes. H.R. 2698: “Health Insurance Certificate Act of 2003” Legislation to provide for a system of health insurance certificates to increase the number of Americans with health insurance coverage. H.R. 2915: “National Health Information Infrastructure Act of 2003” Legislation to provide for a National Health Information Infrastructure and data and communication standards for health Information system interoperability. H.R. 3035: “Medication Errors Reduction Act of 2003” Legislation to establish an informatics grant program for hospitals and skilled nursing facilities in order to encourage health care providers to make major information technology advances. H.R. 4622: “Health Care Choice Act” Legislation to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. H. Res. 522: Expressing the sense of the House of Representatives that there is a critical need to increase awareness and education about heart disease and the risk factors of heart disease among women.

Client expense: Not reported · Firm income: $80,000

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

Public Law 107-250: "Medical Device User Fee and Modernization Act of 2002" Implementation of legislation to amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes. PL 108-214, S. 1881, H.R. 3493: “Medical Devices Technical Corrections Act” Legislation to amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernization Act of 2002, and for other purposes. S. 16: “Protecting Americans Medical Privacy Act” Legislation to protect the civil rights of all Americans, and for other purposes. S. 720, H.R. 663: “Patient Safety and Quality Improvement Act” Legislation to amend title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely affect patient safety. S. 1450, H.R. 1177 Legislation to amend the Internal Revenue Code of 1986 to provide additional choice regarding unused health benefits in cafeteria plans and flexible spending arrangements. S. 1570: “Fair Care for the Uninsured Act of 2003” Legislation to amend the Internal Revenue Code of 1986 to allow individuals a refundable credit against income tax for the purchase of private health insurance, and to establish State health insurance safety-net programs. S. 1909, H.R. 3658: “Stroke Treatment and Ongoing Prevention Act” Legislation to amend the Public Health Service Act to strengthen education, prevention, and treatment programs relating to stroke, and for other purposes. S. 2003: “Health Information for Quality Improvement Act” Legislation to amend the Public Health Service Act to promote higher quality health care and better health by strengthening health information, information infrastructure, and the use of health information by providers and patients. S. 2163: “Small Employers Health Benefits Program Act of 2004” Legislation to establish a national health program administered by the Office of Personnel Management to offer health benefits plans to individuals who are not Federal employees, and for other purposes. S. 2421: “Health Care Modernization, Cost Reduction, and Quality Improvement Act” Legislation to modernize the health care system through the use of information technology and to reduce costs, improves quality, and provides a new focus on prevention with respect to health care. S. 2553, H.R. 4626: “Screening Abdominal Aortic Aneurysms Very Efficiently Act of 2004” Legislation to amend title XVIII of the Social Security Act to provide for coverage of screening ultrasound for abdominal aortic aneurysms under part B of the Medicare program. S. AMDT 2803: Legislation to provide $60 billion over five years for greater health security for working Americans and their families through a combination of public and private efforts to expand quality, affordable health insurance coverage and cut health care costs by eliminating certain tax loopholes. H.R. 815: “Aneurysm Awareness Act” Legislation to require the Secretary of Health and Human Services to conduct a study with respect to aneurysms, and for other purposes. H.R. 1709: “Stop Taking Our Health Privacy (STOHP) Act of 2003” Legislation to restore standards to protect the privacy of individually identifiable health information that were weakened by the August 2002 modifications, and for other purposes. H.R. 2698: “Health Insurance Certificate Act of 2003” Legislation to provide for a system of health insurance certificates to increase the number of Americans with health insurance coverage. H.R. 2915: “National Health Information Infrastructure Act of 2003” Legislation to provide for a National Health Information Infrastructure and data and communication standards for health Information system interoperability. H.R. 3035: “Medication Errors Reduction Act of 2003” Legislation to establish an informatics grant program for hospitals and skilled nursing facilities in order to encourage health care providers to make major information technology advances. H.R. 4622: “Health Care Choice Act” Legislation to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. H. Res. 522: Expressing the sense of the House of Representatives that there is a critical need to increase awareness and education about heart disease and the risk factors of heart disease among women.

Client expense: Not reported · Firm income: $80,000

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

Pl-107-250-Medical Device User Fee and Modernization Act of 2002. (Bill that became the law to finance faster FDA reviews of new medical devices and to make improvements in the regulation of medical devices.) H.R.3493/S.1881-Medical Devices Technical Corrections Act. (Bills to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernizatoin Act of 2002.) S.15/H.R.2122-Project BioShield Act of 2003. S.754-Improved Vaccine Affordability and Availability Act. (Bills to enhance, research, development, procurement, and use of biomedical countermeasures to respond to public health threats affecting national security.) S.877-Patient Safety Improvement Act of 2003. H.R. 663/S.720-Patient Safety and Quality Improvement Act. S. 1775/H.R. 3038-Healthcare Safety Net Amendments Technical Corrections Act of 2003. (Bills intended to provide for the improvement of patient safety and to reduce the incidence of medical errors that adversely affect patient safety.) H.R.5-Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003. S.11-Patients First Act of 2003. (Bills to improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system.) H.R.3140 (PL 108-164)/H.R.2221-Fairness to Contact Lens Consumers Act. H.R.2218/S.1747-To Amend Food and Drug, and Cosmetic Act to Provide for the regulation of all contact lenses as medical devices, and for other purposes. (Bills to regulate all contact lenses as medical devices.) S. Con. Res.80/H. Con. Res. 324-Concurrent resolution urging Japan to honor its commitments under the 1986 Market-Oriented Sector-Selective (MOSS) Agreeement on Medical Equipment and Pharmaceuticals, and for other purposes. (Bills providing that the revolution in medical technology has improved our ability to respond to emerging threats and prevent, identify, treat, and cure a broad range of diseases and disabilities, and has the proven potential to bring even more valuable advances in the future.) H.R.1828-Syria Accountability and Lebanese Sovereignty Restoration Act of 2003. (Section of the bill related to lifting sanctions against export of medical devices as related to Syria and Lebanon.) H.R.1561-United States Patent and Trademark Fee Modernizaton Act of 2003. (The bill to lower patent filing and basic national fees as related to medical devices.)

Client expense: $2,440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office