Patient Safety and Quality Improvement Act of 2004

S. 306, A bill to prohibit discrimination on the basis of genetic information with respect to health insurance and employment. HR 2596, MSAS Health Savings Acct. HR 660 Assn Health Plans. S 1929, Mental Health Parity Extension. S 486, Sen Paul Wellstone Mental Health Parity Extension S 1450 FSA Rollovers Flexible Sprening Accts HR 3901 HR 4372 HR 4520 (S 1637) S 1974 HR 2427 S 2307 S 2328, S 2493 HR 4759 S 2207 HR 4628 S 1945 HR 4279 HR 4372 HR 4280 HR 5 S 11 S 2061 HR 4281 HR 663/S 720 HR 3722 S 486 HR 853 S 1637 HR 4520 S 2572 HR 4694 HR 1818

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 5, the Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003, introduced by Rep. James Greenwood in the House and S. 607 by Senator John Ensign in the Senate 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 2061 A bill to improve women's health access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the delivery of obstetrical and gynecological services – introduced by Senator Judd Gregg. S 2207 A bill to improve women's access to health care services, and the access of all individuals to emergency and trauma care services, by reducing the excessive burden the liability system places on the delivery of such services – introduced by Senator Judd Gregg. HR663, the Patient Safety and Quality Improvement Act, introduced by Rep. Michael Bilirakis in the House Amends the Public Health Service Act to make patient safety work product privileged information. Defines "patient safety work product" as a record concerning patient information either reported to a patient safety organization by a health care provider (doctor, hospital, etc.) or created by a patient safety organization. Defines a "patient safety organization" as an organization, certified under this Act, that collects such information with the goal of improving patient safety and the quality of health care delivery. HR 877: The Patient Safety Improvement Act introduced by Rep. Nancy Johnson Amends title XI of the Social Security Act to add a new part D (Patient Safety Improvements) to provide for voluntary reporting to the Secretary of Health and Human Services of patient safety data. Prescribes confidentiality and peer review protections for such data. Directs the Secretary to ensure that the Center for Quality Improvement and Patient Safety supports public and private sector initiatives to improve patient safety for items and services furnished through health care providers. S. 1053, the Genetic Information Nondiscrimination Act of 2003, introduced by Senator Olympia Snowe. Amends the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code to prohibit health discrimination on the basis of genetic information or services. Defines genetic information as genetic tests of an individual or family member or occurrence of a disease or disorder in family members used to predict risk of disease in asymptomatic or undiagnosed individuals. Defines genetic services as health services provided for genetic education and counseling.

Client expense: $211,129 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

S. 720, Patient Safety and Quality Improvement Act; H.R. 663 Patient Safety and Quaility Improvement Act; S. 11, Patients First Act; S. 1278/H.R. 2507, Conquering Pain Act; programs and legislation that promotes access to health care.

Client expense: Not reported · Firm income: $100,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HEALTH Care Act, S. 1030, H.R. 2402 Support funding to expand existing public programs such as Medicaid and SCHIP to expand coverage for the uninsured, Family Care Act of 2003, S. 1843, Smoking Preventions,H.R.4433. FY ’03-’04 and FY'04-05' Appropriations and budget resolutions (Labor/HHS/Education, VA Research and Medical Care Funding, Bioterrorism)H.R.2660,H.R.2673. Healthcare Anti-trust Improvement Act of 2003,H.R.1120 Patient Safety and Quality Improvement, S.720,H.R.663 National Health Information Infrastructure Act, H.R.2915 Medical Liability, HEALTH Act also Patients First,S.11.H.R.5 Geriatric Care Act (Assessment and Coordination)H.R.102,S.387 College Loan Assistance Act of 2003, H.R.2505 Higher Education Affordability Act (H.R.3412) Improved Vaccine Affordiabilty and Availability Act,S.754 Smallpox Emergency Personnel Protection Act of 2003,P-L108,S.719 Project Bioshield Act of 2003,S.15 Implementation of HIPAA

Client expense: $1,060,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE, White House Office

P.L.108-214-Medical Devices Technical Corrections Act (Public Law to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernization Act of 2002 and to prohibit FDA from arbitrarily raising medical device user fees.) S.15-Project BioShield Act of 2004 H.R.3266-Faster and Smarter Funding for First Responders Act of 2004 H.R.2122-Project BioShield Act of 2003 (Bills to enhance, research, development, procurement, and use of biomedical countermeasures to respond to public health threats affecting national security.) H.R.663/S.720-Patient Safety and Quality Improvement Act (Bills to reduce the number of health care mistakes by defining a new voluntary medical error reporting system.) H.R.3658/S.1909-The Stroke Treatment and Ongoing Prevention Act (To strengthen education, prevention, and treatment programs relating to stroke.) H.R.4280/H.R.5-Medical Malpractice Liability Limitation (HEALTH) Act of 2004 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.) S.2061-Healthy Mothers and Healthy Babies Access to Care Act of 2003 S.2207-Pregnancy and Trauma Care Access Protection Act of 2004 (Bills to improve women's health access to health care services and provide improved medical care by reducing excessive burden the liability system places on the delivery of obstetrical and gynecological services.) S.Con.Res.80/H.Con.Res.324-Concurrent Resolutions urging Japan to honor its commitments under the 1986 Market-Oriented Sector-Selective (MOSS) Agreement on Medical Equipment and Pharmaceuticals, and for other purposes.) (Concurrent Resolutions providing that medical technology has driven dynamic productivity gains for the benefit of patients, providers, employers, and our economy.) P.L.108-286-United States-Australia Free Trade Agreement Implementation Act (Public Law to approve the U.S.-Australia Free Trade Agreement entered into with the Government of Australia, and the statement of administrative action proposed to implement the Agreement.) H.R.4281-Small Business Health Fairness Act of 2004 (Bill to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees.)

Client expense: $2,900,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

Communicated several issues concerning academic health centers to the Secretary of Health and Human Services and his office including: implementation of HIPAA rules, the development of regional electronic patient record systems, and concerns about physician reimbursement rates, medical liability, patient safety, bioterrorism and facilities and administration support. Worked in cooperation with AAMC and AHA to appeal to CMS to consider adjustments to the Medicare sustainable growth rate formula. Johns Hopkins is part of the Maryland/DC Collaborative for Healthcare Information Technology (formerly Maryland/DC E-Health Initiative) to develop and implement a regional electronic patient record system. Continue to keep all members of the Maryland Delegation apprised of the Collaborative’s progress. Monitored HR 663 and S.720, both Patient Safety and Quality Improvement Acts that create voluntary systems for tracking medical errors and promise confidentiality to hospitals and doctors; monitored HR 5, “Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003,” that sets a cap on medical liability; and monitored any Congressional activity that may result from recent court decisions regarding patent infringement claims. Advocated funding and monitored NIH and NSF budgets along with the Association of American Universities (AAU) and Association of American Medical Colleges (AAMC)-see budget section. Monitored S.15, “Project BioShield Act of 2004” Monitored legislation and raised awareness of potential Toomey–type amendments, which would potentially alter the funding of specific NIH-sponsored research projects that had undergone the established peer review processes. Continue to monitor legislative efforts on patient safety, physician reimbursement rates, quality improvement and medical liability.

Client expense: $280,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)

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)

S. 720, Patient Safety and Quality Improvement Act; H.R. 663, Patient Safety and Quality Improvement Act; S. 11, Patients First Act of 2003; HR 663, Patient Safety and Quality Improvement Act; HR 1116, Medical Malpractice Insurance and Litigation Reform Act; S. 1278 & HR 2507, Conquering Pain Act of 2003; Programs and legislation that promotes access to health care for those who are uninsured.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FFY2005 Budget Resolution and Appropriation Bills including Hospital- Related Bioterrorism Preparedness and Workforce Funding Medical Liability Reform-H.R.5/S.607 Pension Preservation and Savings Expansion Act-P.L.108-457 Medicare Inpatient Rehabilitation Facility Payment Modifications-H.R.2246 Medication Errors Reduction Act of 2003-H.R.3035 The Teacher and Nurse Support Act of 2003-H.R.934 Nurse Loan Forgiveness Act-H.R.501 Patient Safety Improvement Act of 2003-S.720;H.R.663;H.R.877 FFY2005 Hospital-Related Bioterrorism Preparedness Funding Paul Wellstone Mental Health Treatment Parity Act-S.486;H.R.953 The Legal Immigrant Children's Health Improvement Act of 2003-S.84;H.R.1689 Medication Errors Reduction Act of 2003-S.1729;H.R.3035 Quality Improvement Act; Funding for Information Technology--S.2710;H.R.4880 Undocumented Immigrant Reporting-H.R.3722 75% Rule for Medicare Inpatient Rehabilitation Facility Prospective Payment System Medicare Inpatient Psychiatric Facility Prospective Payment System Proposed Rule Medicare Inpatient Prospective Payment System Proposed and Final Rule Medicare Skilled Nursing Facility Prospective Payment System Rule Medicare Home Health Prospective Payme System Rule Health Information and Quality Improvement Act-S.2003;S.2710;H.R.4880 Indirect Medical Education Continuation of Increased Federal Medical Assistances Percentage Payments Medicaid Act of 2004-S.2671/H.R.4961 Pregnancy and Trauma Care Access Act-S.2207 Hospital Charity Care/Financial Aid Policy

Client expense: $460,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE

HR 5, the Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003, introduced by Rep. James Greenwood in the House and S. 607 by Senator John Ensign in the Senate 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 2061 A bill to improve women's health access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the delivery of obstetrical and gynecological services – introduced by Senator Judd Gregg. S 2207 A bill to improve women's access to health care services, and the access of all individuals to emergency and trauma care services, by reducing the excessive burden the liability system places on the delivery of such services – introduced by Senator Judd Gregg. HR663, the Patient Safety and Quality Improvement Act, introduced by Rep. Michael Bilirakis in the House Amends the Public Health Service Act to make patient safety work product privileged information. Defines "patient safety work product" as a record concerning patient information either reported to a patient safety organization by a health care provider (doctor, hospital, etc.) or created by a patient safety organization. Defines a "patient safety organization" as an organization, certified under this Act, that collects such information with the goal of improving patient safety and the quality of health care delivery. HR 877: The Patient Safety Improvement Act introduced by Rep. Nancy Johnson Amends title XI of the Social Security Act to add a new part D (Patient Safety Improvements) to provide for voluntary reporting to the Secretary of Health and Human Services of patient safety data. Prescribes confidentiality and peer review protections for such data. Directs the Secretary to ensure that the Center for Quality Improvement and Patient Safety supports public and private sector initiatives to improve patient safety for items and services furnished through health care providers. S. 1053, the Genetic Information Nondiscrimination Act of 2003, introduced by Senator Olympia Snowe. Amends the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code to prohibit health discrimination on the basis of genetic information or services. Defines genetic information as genetic tests of an individual or family member or occurrence of a disease or disorder in family members used to predict risk of disease in asymptomatic or undiagnosed individuals. Defines genetic services as health services provided for genetic education and counseling.

Client expense: $187,307 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), President of the U.S., SENATE

Medical Liability Reform (S.607/H.R.5); Pension Preservation and Savings Expansion Act of 2003 (H.R.1776); Medicare Inpatient Rehabilitation Facility Payment Modifications (H.R. 2246); Medication Errors Reduction Act of 2003 (H.R. 3035); Teacher and Nurse Support Act of 2003 (H.R. 934); Nurse Loan Forgiveness Act (H.R. 501); Patient Safety Improvement Act of 2003 (S.720/H.R. 663 and 877); FFY 2005 Hospital-Related Bioterrorism Preparedness Funding; Paul Wellstone Mental Health Treatment Parity Act (S.486/H.R. 953); Legal Immigrant Children's Health Improvement Act of 2003 (S.845/H.R. 1689); Medication Errors Reduction Act of 2003 (S.1729/H.R. 3035)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical Liability Reform (S.607/H.R.5); Pension Preservation and Savings Expansion Act of 2003 (H.R.1776); Medicare Inpatient Rehabilitation Facility Payment Modifications (H.R. 2246); Medication Errors Reduction Act of 2003 (H.R. 3035); Teacher and Nurse Support Act of 2003 (H.R. 934); Nurse Loan Forgiveness Act (H.R. 501); Patient Safety Improvement Act of 2003 (S.720/H.R. 663 and 877); FFY 2005 Hospital-Related Bioterrorism Preparedness Funding; Paul Wellstone Mental Health Treatment Parity Act (S.486/H.R. 953); Legal Immigrant Children's Health Improvement Act of 2003 (S.845/H.R. 1689); Medication Errors Reduction Act of 2003 (S.1729/H.R. 3035)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FFY 2004 Budget Resolution FFY 2004 Labor HHS Appropriations Bill S.889,H.R.1710 The American Hospital Preservation Act of 2003 H.R.1580 the Area Wage and Standardized Rate Act S.138,H.R.816 State Budget Relief Act of 2003 S.511,S.607,H.R.5 Medical Liability Reform S.652,H.R.328 Medicaid DSH Access to Hospitals Act H.R.810 Medicare Regulatory and Contracting Reform Act H.R.1776 The Pension Preservation and Savings Expansion Act of 2003 S.1222, H.R.2246 Medicare Inpatient Rehab. Facility Payment Modifications H.R.934 The Teacher and Nurse Support Act of 2003 H.R.501 Nurse Loan Forgiveness Act S.720,H.R.663,H.R.877 Patient Safety Improvement Act S.869,H.R.817 Assure Access to Mammography Act S.412,H.R.819 Local Medical Emergency Reimbursement Act of 2003 S.486,H.R.953 Paul Wellstone Mental Health Treatment Parity Act S.845,H.R.1689 Legal Immigrant Children's Health Improvement Act of 2003 S.816, H.R.1675 Health Care Access and Rural Equity Act of 2003 H.R.3035 Medication Errors Reduction Act of 2003 H.R.3722 Reporting Undocumented Immigrants Receiving Care S.1, H.R.1 Prescription Drug Benefit P.L.108-173 Medicare Prescription Drug, Improvement and Modernization Act of 2003 P.L.108-27 Jobs & Growth Tax Relief Reconciliation Act H.R.1770 Smallpox Emergency Personnel Protection Act EMTALA Standards Sarbanes-Oxley regulation Internal Revenue Service Form 990 reporting regulations Provider-based designation regulations Indirect Medical Education Relief CMS Conditions of Participation Requirements Automatic implantable cardioverter defibrillators CMS Proposed Outlier Payment Methodology modifications CMS Proposed Patient Experiences of Care Survey Tool CMS Hospital Quality Reporting Pilot Project CMS Proposed Inpatient Rehabilitation PPS Regulations CMS Proposed Inpatient PPS Regulations CMS Proposed Outpatient PPS Regulations CMS Proposed Skilled Nursing Facility PPS Regulations CMS Proposed Inpatient Psychiatric Facility PPS Regulations FDA Bar Code Label Requirements for Human Drug Products and Blood CMS Home Health Quality Initiative CMS Occupational Case Mix Survey

Client expense: $480,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE

S. 11, Patients First Act of 2003; HR 663, Patient Safety and Quality Improvement Act; HR 1116, Medical Malpractice Insurance and Litigation Reform Act; S. 1278 & HR 2507, Conquering Pain Act of 2003; Programs and legislation that promotes more health care access for individuals who are uninsured; Establishment of Critical Access Clinics under Public Health Act.

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

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

HEALTH Care Act, S. 1030, H.R. 2402 Support funding to expand existing public programs such as Medicaid and SCHIP to expand coverage for the uninsured, Family Care Act of 2003, S. 1843 FY ’03-’04 Appropriations and budget resolutions (Labor/HHS/Education, VA Research and Medical Care funding, and Bioteerrorism), H.R.2660, H.R.2673 Healthcare Anti-trust Improvement Act of 2003,H.R.1120 Patient Safety and Quality Improvement, S.720,H.R.663 National Health Information Infrastructure Act, H.R.2915 Medical Liability, HEALTH Act, also Patients First, S.11,H.R.5 Geriatric Care Act (Assessment and Coordunation),H.R.102,S.387 College Loan Assistance Act of 2003,H.R.2505 Improved Vaccine Affordability and Availability Act,S.754 Smallpox Emergency Personnel Protection Act of 2003,P-L108-20,S.719 Project Bioshield Act of 2003,S.15 Implementation of HIPAA

Client expense: $1,060,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE, White House Office

HR 5, the Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003, introduced by Rep. James Greenwood in the House and S. 607 by Senator John Ensign in the Senate 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. HR663, the Patient Safety and Quality Improvement Act, introduced by Rep. Michael Bilirakis in the House Amends the Public Health Service Act to make patient safety work product privileged information. Defines "patient safety work product" as a record concerning patient information either reported to a patient safety organization by a health care provider (doctor, hospital, etc.) or created by a patient safety organization. Defines a "patient safety organization" as an organization, certified under this Act, that collects such information with the goal of improving patient safety and the quality of health care delivery. HR 877: The Patient Safety Improvement Act introduced by Rep. Nancy Johnson Amends title XI of the Social Security Act to add a new part D (Patient Safety Improvements) to provide for voluntary reporting to the Secretary of Health and Human Services of patient safety data. Prescribes confidentiality and peer review protections for such data. Directs the Secretary to ensure that the Center for Quality Improvement and Patient Safety supports public and private sector initiatives to improve patient safety for items and services furnished through health care providers. S. 1053, the Genetic Information Nondiscrimination Act of 2003, introduced by Senator Olympia Snowe. Amends the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code to prohibit health discrimination on the basis of genetic information or services. Defines genetic information as genetic tests of an individual or family member or occurrence of a disease or disorder in family members used to predict risk of disease in asymptomatic or undiagnosed individuals. Defines genetic services as health services provided for genetic education and counseling.

Client expense: $160,878 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), President of the U.S., SENATE

H.R. 663, Patient Safety and Quality Improvement Act of 2003 S. 720, Patient Safety and Quality Improvement Act of 2003 H.R. 5, Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003 (also known as S. 607, S. 11) H.R. 296, Treatment of Children's Deformities Act of 2003 (also known as S. 977) H.R. 1770, Smallpox Emergency Personnel Protection Act of 2003 (also S. 719) H.R. 2122, Project BioShield Act of 2003 (also S. 1504) Isotretinoin regulatory program Tanning bed regulatory program CLIA regulatory program

Client expense: $250,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 663, Patient Safety and Quality Improvement Act of 2003 S. 720, Patient Safety and Quality Improvement Act of 2003 H.R. 5, Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003 (also known as S. 607, S.11) H.R. 296, Treatment of Children's Deformities Act of 2003 (also known as S. 977) H.R. 1770, Smallpox Emergency Personnel Protection Act of 2003 (also S. 719) H.R. 2122, Project BioShield Act of 2003 (also S. 1504) Isotretinoin regulatory program Tanning bed regulatory program CLIA regulatory program

Client expense: $250,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Medicare Inpatient Marketbasket and Indirect Medical Education: The American Hospital Preservation Act of 2003 (H.R.1710/S.899); Medicare Rural, Small Community, and Small City Hospital Package: The Area Wage Index and Standardized Rate Act (H.R.1580); Medicaid: The State Budget Relief Act of 2003 (original bill: H.R.816/S.138); Medical Liability Reform-Help Efficient, Accessible, Low Cost, Timely Health Care (HEALTH) Act of 2003 (H.R.5/S.607); Medicare Rehabilitation Hospital Inpatient Payment Modifications (H.R.2246/s.1222); Rural Hospital Package-Health Care Access and Rural Equity Act of 2003 (H.R.1675/S.816); Regulatory Reform-Medicare Regulatory and Contracting Reform Act. (H.R.810); Pension Fund Protection: The Pension Preservation and Savings Expansion Act of 2003 (H.R.1776); Medication Errors Reduction Act of 2003 (H.R.3035); Teacher and Nurse Support Act of 2003 (H.R.934); Nurse Loan Forgiveness Act (H.R.501); Patient Safety Improvement Act of 2003 (H.R.663/H.R.877/S.720); Assure Access to Mammography Act (H.R.817/869); Local Medical Emergency Reimbursement Act of 2003 (S.412/H.R.819); Paul Wellstone Mental Health Treatment Parity Act (S.486/H.R.953); Elimination of Restrictions on Federal Medicaid and S-CHIP Coverage: The Legal Immigrant Children's Health Improvement Act of 2003 (H.R.1689/S.845);

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Communicated several issues concerning academic health centers to the Secretary of Health and Human Services including: implementation of HIPAA rules and the development of electronic patient record systems, concerns about medical malpractice, bioterrorism and facilities funding. Specifically, Johns Hopkins is part of a Maryland/DC E-Health Initiative to devise a regional electronic patient record system; we are monitoring HR 663 and S 720, both Patient Safety and Quality Improvement Acts that create voluntary systems for tracking medical errors and promise confidentiality to hospitals and doctors; monitoring HR 5, “Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003,") that sets a cap on medical liability; and monitoring any Congressional activity that may result from recent court decisions regarding patent infringement claims. Advocated for funding and monitored NIH and NSF budgets along with Association of American Medical Colleges (AAMC)–see budget section. Monitored S.1504/HR 2122, "Project BioShield Act of 2003," HCR 95,S. 1505 and HSA smallpox vaccination program implementation.

Client expense: $320,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

FFY 2004 Budget Resolution FFY 2004 Labor HHS Appropriations Bill S.889, H.R.1710 The American Hospital Preservation Act of 2003 H.R.1580 The Area Wage and Standardized Rate Act S.138, H.R.816 State Budget Relief Act of 2003 S.511, S.607, H.R.5 Medical Liability Reform S.652, H.R.328 Medicaid DSH: Access to Hospitals Act H.R.810 Medicare Regulatory and Contracting Reform Act H.R.1776 The Pension Preservation and Savings Expansion Act of 2003 S.1222, H.R.2246 Medicare Inaptient Rehab. Facility Payment Modifications H.R.934 The Teacher and Nurse Support Act of 2003 H.R.501 Nurse Loan Forgiveness Act S.720, H.R.663, H.R.877 Patient Safety Improvement Act S.869, H.R.817 Assure Access to Mammography Act S.412, H.R.819 Local Medical Emergency Reimbursement Act of 2003 S.486, H.R.953 Paul Wellstone Mental Health Treatment Parity Act S.845, H.R.1689 Legal Immigrant Children's Health Improvement Act of 2003 S.816, H.R.1675 Health Care Access and Rural Equity Act of 2003 S.1, H.R.1 Prescription Drug Benefit H.R.1770 Smallpox Emergency Personnel Protection Act EMTALA Standards Sarbanes-Oxley regulation Internal Revenue Service Form 990 reporting regulations Provider-based designation regulations CMS Conditions of Participation Requirements Automatic implantable cardioverter defibrillators CMS Proposed Outlier Payment Methodology modifications CMS Proposed Patient Experience of Care Survey Tool CMS Hospital Quality Reporting Pilot Project CMS Proposed Inpatient Rehablitation PPS Regulations CMS Proposed Inpatient PPS Regulations CMS Proposed Outpatient PPS Regulations CMS Proposed Skilled Nursing Facility PPS Regulations FDA Bar Code Label Requirements for Human Drug Products and Blood CMS Home Health Quality Initiative CMS Occupational Case Mix Survey

Client expense: $460,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE

PL 107-250-Medical Device User Fee and Modernization Act of 2002 (Bill that became the law to finance faster FDA reviws of new medical devices and to make improvements in the regulation of medical devices.) H.R.2122/S.15-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 natinal security.) H.R.663/S.720-Patient Safety and Quality Improvement Act S. 877-Patient Safety Improvement Act of 2003 (Bills intended to provide for the improvment 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.)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), SENATE

S. 10: “Health Care Coverage Expansion and Quality Improvement Act of 2003” Legislation to protect consumers in managed care plans and other health coverage, to provide for parity with respect to mental health coverage, to reduce medical errors, and to increase the access of individuals to quality health care S. 16: “Protecting Americans Medical Privacy Act” Legislation to protect the civil rights of all Americans, and for other purposes. S. 732: "Health Care Safety Net Oversight Act of 2003" Legislation to amend title XI of the Social Security Act to create an independent and nonpartisan commission to assess the health care needs of the uninsured and to monitor the financial stability of the Nation's health care safety net. H.R. 596: “ERISA Clarification Act of 2003” Legislation to amend title I of the Employee Retirement Income Security Act of 1974 to exclude from preemption State causes of action to enforce determinations under group health plans based on medical necessity. H.R. 597: “Patient Protection Act” Legislation to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to protect consumers in managed care plans and other health coverage. 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, and for other purposes. 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. Department of Health and Human Services, Office of the Secretary, 45 CFR Parts 160 and 164, Standards for the Privacy of Individually Identifiable Health Information; Final Rule, August 2002.

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

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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

HR 5, the Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003, introduced by Rep. James Greenwood in the House and S. 607 by Senator John Ensign in the Senate 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. HR663, the Patient Safety and Quality Improvement Act, introduced by Rep. Michael Bilirakis in the House Amends the Public Health Service Act to make patient safety work product privileged information. Defines "patient safety work product" as a record concerning patient information either reported to a patient safety organization by a health care provider (doctor, hospital, etc.) or created by a patient safety organization. Defines a "patient safety organization" as an organization, certified under this Act, that collects such information with the goal of improving patient safety and the quality of health care delivery. HR 877: The Patient Safety Improvement Act introduced by Rep. Nancy Johnson Amends title XI of the Social Security Act to add a new part D (Patient Safety Improvements) to provide for voluntary reporting to the Secretary of Health and Human Services of patient safety data. Prescribes confidentiality and peer review protections for such data. Directs the Secretary to ensure that the Center for Quality Improvement and Patient Safety supports public and private sector initiatives to improve patient safety for items and services furnished through health care providers. S. 1053, the Genetic Information Nondiscrimination Act of 2003, introduced by Senator Olympia Snowe. Amends the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code to prohibit health discrimination on the basis of genetic information or services. Defines genetic information as genetic tests of an individual or family member or occurrence of a disease or disorder in family members used to predict risk of disease in asymptomatic or undiagnosed individuals. Defines genetic services as health services provided for genetic education and counseling.

Client expense: $148,062 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Council of Economic Advisers (CEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

Medicare Inpatient Marketbasket and Indirect Medical Education: The American Hospital Preservation Act of 2003 (S899/H.R.1710); Medicare Rural, Small Community, and Small City Hospital Package: The Area Wage and Standardized Rate Act (S.pending/H.R.1580); Medicaid: State Budget Relief Act of 2003 (S.138/H.R.816); Medical Liability Reform: Help Efficient, Accessible, Low Cost, Timely Health Care (HEALTH) Act of 2003 (S.607/H.R.5); Medicaid DSH: Access to Hospitals Act (S.652/H.R.328); Regulatory Reform: Medicare Regulatory and Contracting Reform Act (S.pending/H.R.810); The Pension Preservation and Savings Expansion Act of 2003 (S.pending/H.R.1776); Medicare Inpatient Rehabilitation Facility Payment Modifications (S.pending/H.R.2246); The Teacher and Nurse Support Act of 2003 (S.pending/H.R.934); Nurse Loan Forgiveness Act (S.pending/H.R.501); Patient Safety Improvement Act of 2003 (S.720/H.R.663 & 877); FFY 2004 Hospital-Related Bioterrorism Preparedness Funding (President's FFY 2004 Budget Proposal); Assure Access to Mammography Act (S.869/H.R.817); Local Medical Emergency Reimbursement Act of 2003 (S.412/H.R.819); Paul Wellstone Mental Health Treatment Parity Act (S.486/H.R.953); The Legal Immigrant Children's Health Improvement Act of 2003 (S.845/H.R.1689)

Client expense: Not reported · Firm income: Not reported