Patient Safety Improvement Act of 2002

H.R.1078 HCR Broken Promises Retiree Health Coverage Act of 2001 H.R.1322 HCR Emergency Retiree Health Benefits Protection Act of 2001 H.R.1774 HCR Small Business Health Fairness Act of 2001 H.R.1809 HCR Cancer Screening Coverage Act of 2002 H.R.2036 HCR Social Security Number Privacy and Identity Theft Prevention Act of 2001 H.R.2563 HCR Bipartisan Patient Protection Act H.R.2658 HCR Health Care Account Act of 2001 H.R.3009 HCR Trade Act of 2002 H.R.3040 HCR COBRA Coverage Act of 2001 H.R.3529 HCR Economic Security and Worker Assistance Act of 2001 H.R.3684 HCR Early Medicare Access and Affordability Act of 2002 H.R.4066 HCR Mental Health Equitable Treatment Act of 2002, Entire H.R.4600 HCR Help Efficient, Accessible, Low Cost, Timely Health Care (HEALTH) Act of 2002 H.R.4889 HCR Patient Safety Improvement Act of 2002 H.R.4954 HCR Medicare Modernization and Prescription Drug Act of 2002 H.R.5646 HCR Stop Taking Our Health Privacy (STOHP) Act of 2002 H.R.5716 HCR Mental Health Parity Reauthorization Act of 2002 S.104 HCR Equity in Prescription Insurance and Contraceptive Coverage Act of 2001 S.318 HCR Genetic Nondiscrimination in Health Insurance and Employment Act S.543 HCR Mental Health Equitable Treatment Act of 2001, Entire S.590 HCR Relief, Equity, Access, and Coverage for Health (REACH) Act S.710 HCR Eliminate Colorectal Cancer Act of 2001, Entire S.812 HCR Greater Access to Affordable Pharmaceuticals Act of 2001 S.848 HCR Social Security Number Misuse Prevention Act of 2002 S.1052 HCR Bipartisan Patient Protection Act S.1209 HCR Trade Adjustment Assistance for Workers, Farmers, Communities, and Firms S.1454 HCR Displaced Workers Assistance Act S.1502 HCR COBRA Plus Act of 2001 S.1995 HCR Genetic Information Nondiscrimination Act of 2002 S.2042 HCR Access to Affordable Health Care Act S.2328 HCR SMART Mom Act S.2590 HCR Patient Safety and Quality Improvement Act, Entire S.2590 HCR Patient Safety and Quality Improvement Act S.2625 HCR Medicare Outpatient Prescription Drug Act of 2002 S.2679 HCR Health Insurance Access Act of 2002 S.2729 HCR 21st Century Medicare Act S.2736 HCR Medicare Rx Drug Discount and Security Act of 2002 S.2766 HCR Department of Labor, HHS, and Education Appropriations, FY2003 bill  S.2904 HCR Emergency Retiree Health Benefits Protection Act of 2002 S.3018 HCR Beneficiary Access to Care and Medicare Equity Act of 2002

Client expense: $160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Pension & Welfare Benefits Administration, Pension Benefit Guaranty Corporation (PBGC), SENATE, Treasury, Dept of

H.R.3580-Medical Device Amendments of 2001 H.R.5651/P.L.107-250-Medical Device User Fee and Modernization Act 2002 (Bills to amend the Federal Food and Drug, and Cosmetic Act to make improvements in the regulation of medical devices.) H.R.3448/P.L.107-188-Public Health Security and Bioterrorism Preparedness Response Act of 2002 S.2452-National Emergency Preparedness Enhancement Act o f2002 S.1764-Robert Stevens, Thomas Morris, Jr., Joseph Curseen, Kathy Nguyen, Ottille Lundgren and Lisa J. Raines Biological and Chemical Weapons Research Act S.2115-Homeland Security Act of 2002 H.R.5005-Homeland Security Act of 2002 H.R.4660-Bioterrorism Protection Act (BioAct) of 2001 H.R.3255/S.1747-Science and Technology Emergency Mobilization Act S.2037-Department of Veterans Affairs Emergency Preparedness Research, Education, and Bioterrorism Prevention Act of 2002 H.R.3253-Pathogen Research, Emergency Preparedness and Response Eforts Act of 2001 S.1635-Biological Preparedness Act of 2001 S.1715/S.1765-Bioterrorism Preparedness Act of 2001 H.R.5005/H.R.5710-Homeland Security Act of 2002 H.R.5023-Dirty Bomb Prevention Act S.2648-Working Toward Independence Act of 2002 S.2684-Dirty Bomb Prevention Act of 2002 (Bills to combat terrorism and to establish the Department of National Homeland Security and the National Office for Combating Terrorism) S.2590-Patient Safety and Quality Improvement Act H.R.4600-To improve patient access to health care sevices and provide improved medical care by reducing excessive burden the liability system places on the health care delivery system H.R.4889-To amend Title XI of Social Security Act to Improve Patient Safety S.824-Medication Errors Reduction Act of 2001 H.R.5478-Patient Safety and Quality Improvemnt Act H.R.3029-Patient Safety Improvements and Medical Injury Reducton Act (Bills intended to reduce medical errors and to enhance research on medical errors as it may directly or indirectly relate to medical technology) H.R.4600-Help Efficient, Accessible, Low Cost, Timely Health Care (HEALTH) Act of 2002 H.R. 2103-Medical Malpractice Rx Act (To reduce malpractice lawsuits as it relates to medical technology) H.R.3005-Bipartisan Trade Promotion Authority Act of 2002 (Bill to extend trade authorities protecton with respect to reciprocal trade agreements) H.R.4602-SMART Mom Act S.961/H.R.1961-A bill to promote research to identify and evaulate the health effects of breast implants; to ensure that women receive accruate information about such implants and to encourage the FDA to thoroughly review the implant manufacturers' standing with the agency (Bills relating to biomaterials for the breast implants) H.R. 2383-To amend the Inernal Revenue Code of 1986 to increase and modify the exclusion relating to qualified small business stock and to provide that the exclusion relating to incentive stock options will no longer be a minimun tax preference H.R.2153-Americans Breakthrough Research Act of 2001 (Bills to amend the Internal Code of 1986 and to allow small business to grow as related to medical technology) H.R.4697-Human Research Subject Protections Act of 2002 S.3060-Research Revitalization Act of 2002 (Bills to provide protections for human participants in research) HR5095-American Competitiveness and Corporate Accountability Act of 2002 HR3462-Community Access to Emergency Defibrillation Act of 2001 (Bill to provide grants for public access defibrillaton programs and public access defibrillation demonstraton projects)

HR 4600 - HELP Act - Medical Malpractice HR 4889 Patient Safety Improvement Act (Medical errors) S. 2024 Mobility devices Evidence based medicine Medical devices

Client expense: $131,540 · Firm income: Not reported

H.R.854/S.572 Medicaid Safety Net Hospital Continued Preservation Act of 2001 H.R.1556/S.839 American Hospital Preservation Act of 2001 S.135 Direct Graduate Medical Education Improvement Act of 2001 H.R.4889 to ament title IX of the Social Security Act to improve patient safety H.R.4600/S.2793 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 system.

Client expense: $14,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Privacy Regulation -- On August 14, 2002, the DHHS Office of the Secretary published a final rule establishing Standards for Privacy of Individually Identifiable Health Information. The Privacy Rule makes optional the requirement that providers obtain a patient’s signed consent before using or disclosing a patient’s protected health information; requires covered entities to make reasonable efforts to limit the use and disclosure of and request for, protected health information to the minimum necessary to accomplish the intended purpose; requires covered entities to have contracts with their business associates to ensure the business associates protect the privacy of the information; requires covered entities to first obtain the individual’s specific authorization before sending them any marketing materials; simplifies provisions of the existing rule to more closely follows the requirements of the “Common Rule,” which governs federally-funded research. HR 3323, that would extend the deadline for entities to be in compliance with the transaction standards of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) by one year. Liability and prompt payment provisions of the various Patients’ Bill of Rights: S. 899, the Bipartisan Patients’ Bill of Rights Act of 2001, introduced by Senators Bill Frist (R-TN), John Breaux (D-LA), and James Jeffords (R-VT) treatment of health plan and employer liability creating a limited right for patients to sue their health plans in federal court if they feel they have been improperly denied care. S. 1052 “Bipartisan Patient Protection Act” introduced by Sens. John McCain (R-AZ), John Edwards (D-NC), and Edward Kennedy (D-MA). The bill includes a broad range of patient protections nearly universally available throughout the states enabling access to pediatricians, obstetricians, emergency room services, and rights to appeal health plan decisions. HR 2563, the Bipartisan Patient Protection Act introduced by Rep. Charlie Norwood and Rep. Bill Thomas offering a compromise on the treatment of health plan and employer liability creating a limited right for patients to sue their health plans. S. 2590: Introduced by Senator Jim Jeffords. A bill to amend title IX of the Public Heath Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely effect patient safety. HR 4889: The Patient Safety and Quality Improvement Act introduced by Rep. Nancy Johnson to provide for the improvement of patient safety and reduce the incidence of events that adversely effect patient safety. HR 4600: Introduced by Rep. James Greenwood 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.

S. 1055: "Privacy Act of 2001" Legislation to require the consent of an individual prior to the sale and marketing of such individual's personally identifiable information, and for other purposes. S. 2201: "Online Personal Privacy Act" Legislation to protect the online privacy of individuals who use the Internet. H.R. 4678: "Consumer Privacy Protection Act of 2002" Legislation to protect and enhance consumer privacy, and for other purposes. Department of Health & Human Services 45 CFR Parts 160 and 164, Office of the Secretary: Standards for Privacy of Individually Identifiable Health Information: Proposed Rule, March 27, 2002 S. 2639: "Health Care for Working Families Act" Legislation to provide health benefits for workers and their families. H.Con Res. 271: "Expressing the sense of the Congress that public awareness and education about the importance of health care coverage is of the utmost priority and that a National Importance of Health Care Coverage Month should be established to promote these goals". S. 2638: "eHealth Act of 2002" Legislation to encourage health care facilities, group health plans, and health insurance issuers to reduce administrative costs, and to improve access, convenience, quality, and safety, and for other purposes. H.R. 4889: "Patient Safety Improvement Act of 2002" Legislation to amend title XI of the Social Security Act to improve patient safety. S. 1765, H.R. 3448, S. Con. Res. 117, H. Res. 427, : "Public Health Security and Bioterrorism Response Act of 2001" Legislation to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. Provisions relating to prescription drugs and user fees, and export control for FDA regulated products. H.R. 3580: "Medical Device Amendments of 2001" Legislation to amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes. H.R. 4697: "Human Research Subject Protections Act of 2002" Legislation to amend the Public Health Service Act with respect to the protection of human subjects in research.

Privacy Regulation -- On December 28, 2000, the DHHS Office of the Secretary published a final rule establishing Standards for Privacy of Individually Identifiable Health Information. On March 27, the Secretary published a NPRM This rule includes standards, which apply to health plans, health care clearinghouses, and health care providers, establishing the rights of individuals who are the subjects of this information, procedures for the exercise of those rights, and the authorized and required uses and disclosures of this information. The rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996. On March 27 HHS published a rule proposing modifications to the Standards for Privacy of Individually Identifiable Health Information. The Privacy Rule makes optional the requirement that providers obtain a patient’s signed consent before using or disclosing a patient’s protected health information; requires covered entities to make reasonable efforts to limit the use and disclosure of and request for, protected health information to the minimum necessary to accomplish the intended purpose; requires covered entities to have contracts with their business associates to ensure the business associates protect the privacy of the information; requires covered entities to first obtain the individual’s specific authorization before sending them any marketing materials; simplifies provisions of the existing rule to more closely follows the requirements of the “Common Rule,” which governs federally-funded research. HR 3323, that would extend the deadline for entities to be in compliance with the transaction standards of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) by one year. Liability and prompt payment provisions of the various Patients’ Bill of Rights: S. 899, the Bipartisan Patients’ Bill of Rights Act of 2001, introduced by Senators Bill Frist (R-TN), John Breaux (D-LA), and James Jeffords (R-VT) treatment of health plan and employer liability creating a limited right for patients to sue their health plans in federal court if they feel they have been improperly denied care. S. 1052 “Bipartisan Patient Protection Act” introduced by Sens. John McCain (R-AZ), John Edwards (D-NC), and Edward Kennedy (D-MA). The bill includes a broad range of patient protections nearly universally available throughout the states enabling access to pediatricians, obstetricians, emergency room services, and rights to appeal health plan decisions. HR 2563, the Bipartisan Patient Protection Act introduced by Rep. Charlie Norwood and Rep. Bill Thomas offering a compromise on the treatment of health plan and employer liability creating a limited right for patients to sue their health plans. S. 2590: Introduced by Senator Jim Jeffords. A bill to amend title IX of the Public Heath Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely effect patient safety. HR 4889: The Patient Safety and Quality Improvement Act introduced by Rep. Nancy Johnson to provide for the improvement of patient safety and reduce the incidence of events that adversely effect patient safety. HR 4600: Introduced by Rep. James Greenwood 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.