Help Efficient, Accessible, Low Cost, Timely Health Care (HEALTH) Act of 2002

PL104-191,Health Insurance Portability and Accountability Act:advocated through formal comment process to seek changes and modifications in HIPAA with respect to treatment of patient privacy and charitable contributions; HR3487/S.1864,Nurse Reinvestment Act:monitored progress of negotiations of informal conference committee seeking compromise;Monitored progress of Senate bill (Kennedy/Frist)and House bill, HR4697,Human Research Subject Protections Act of 2002, which would increase the protection of participants in human subject research;S.543,Mental Health Equitable Treatment Act of 2001:monitored bill which would provide for equal coverage of mental health benefits with respect to health insurance coverage;monitored HR2178,All-Payer Graduate Medical Education Act of 2001(Representative Ben Cardin):a bill to provide comprehensive financing for graduate medical education;monitored HR 3236,Patient and Physician Safety and Protection Act of 2001(Representative Conyers):to amend Title XVIII of the Social Security Act to reduce the work hours and increase the supervision of resident-physicians to ensure the safety of patients and resident-physicians themselves; monitored HR 4600, The Help Efficient,Accessible,Low Cost, Timely Health Care Act of 2001(Representative Jim 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;Provided comments to Maryland Senators in response to hearing before the Senate Health,Education, Labor and Pensions Committee(4/16/02) on proposed amendments to the Health Insurance Portability and Accountability Act (HIPA)privacy regulations.

Client expense: $240,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

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

Health issues including genetics legislation, asociation health plan legislation (H.R. 2990), medical liability legislation. (H.R.4600) and and patients bill of rights (H.R.2563, S.1052. Contacts with executive branch include meetings with DOL and White House on patients bill of rights.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health issues include medical liability legislation (H.R. 4600) and patients bill of rights (H.R. 2563, S. 1052). Contacts with executive branch include contact with Treasury Department on Rev. Ruling re: health care reimbursement accounts.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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)

Client expense: $2,860,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Health issues included medical liability legislation (H.R. 4600) and legislation to address subrogation issues (no bills intruduced).

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Fiscal Year 2003 Budget Resolution S.839,H.R.4954,H.R.1556 The American Hospital Preservation Act S.885,H.R.4954,H.R.1609 The Rural & Small Community Hospital Area Wage and Base Payment Improvement Act S.2547 The Hospital Outpatient Fair Payment Act of 2002 S.2555 The Revitalizing Under-Served Rural Areas and Localities Act S.2615,H.R.4515 The Rural Community Hospital Assistance Act S.326,H.R.4954,H.R.975 The Home Health Payment Fairness Act S.2490,H.R.4954 Medicare Skilled Nursing Beneficiary Protection Act of 2002 S.812,H.R.3414,S.2110 State Budget Relief Act of 2001 S.J.Res.37/H.J.Res.92 Resolution of Disapproval--Overturn Medicaid Upper Payment Limit Reduction S.1745,H.R.3360 Delay in Medicaid Upper Payment Limit Reduction S.572,H.R.854 Medicaid Safety Net Hospital Continued Preservation Act H.R.287 Prompt Payment of Health Benefits Claims Act H.R.4600 Helping to Ensure Affordable, Low-Cost, Timely Health Care Act of 2002 S.706,H.R.1436 The Nurse Reinvestment Act H.R.1897 The Nurse of Tomorrow Act S.705,H.R.3292 The Health Information Technology and Quality Improvement Act/Medication Errors Reduction Act of 2001 S.548,H.R.4954,H.R.1354 Assure Access to Mammography Act S.582,H.R.1143 The Immigrant Children's Health Improvement Act of 2001 S.2449 Federal Responsibility for Immigrant Health Act S.169,H.R.519 Local Medical Emergency Reimbursement Act S.1715,H.R.3448 Public Health Security and Bioterrorism Response Act of 2001 HHS Emergency Readiness Funding for Health Care Providers Disaster Relief Funding for Health Care Providers Medicare Prescription Drug Coverage & Provider Payment Increase Legislation Inpatient, Outpatient, Home Health, Skilled Nursing Facility and Long Term Care Hospital (LTCH) PPS Regulations Continuation of Agriculture Department's J-1 Visa Program CMS Seventh Scope of Work for Quality Improvement Organizations CMS Outcomes-based Quality Improvement in Home Health Care CMS Proposed Expansion of Post-Acute Care Transfer Payment EMTALA Regulations Provider-based Regulations Corporate Compliance Department of Labor Regulations on Benefit Claim Appeals HHS Regulatory Reform Efforts IRS Intermediate Sanction Rules Upper Payment Limit Rules HIPAA Rules Medical Malpractice

Client expense: $360,000 · Firm income: Not reported

Government targets: 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), Office of the Vice President of the United States, SENATE

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

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Federal Communications Commission (FCC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR)

FY'03Appropriations (Labor/HHS/Education and VA Research and Medical Care funding and Bioterrorism) FY'04 Omnibus Appropriations Flu Vaccine Availability Act of 2001 - H.R.943 Antibotic Resistance Prevention Act of 2001 - H.R.1771 Smallpox Vaccination policy Underserved Adult and Adolescent Immunization Act of 2001 - H.R.2598 Bipartisan Patient Bill of Rights - S.1052/H.R.526,H.R.2663 Federal District Court order requiring Peer Review Organizations(PROs) to release physician information. Support for funding to expand the exsisting public progeams such as Medicaid and SCHIP to expand coverage for the uninsured(S.2679). Health Insurance Flexibility and Affordability(HIFA)Initative Medicare Education and Regulatory Fairness Act of 2001(MERFA)-H.R.868 Medicare Regulatory and Contracting Reform Act of 2001,S..1738 Privacy Rule-HIPAA Extension for standard transaction and code set regulations under HIPAA Administrative Simplification Compliance Act of 2001 - S.1684,H.R.1684 COBRA Plus Act of 2001 Economic Recovery and Assistance for American Workers Act of 2001 Geriatric Care Act-S.775 The Disabled Veterans Service Dog and Health Care Improvement Act of 2001-H.R.2792 Funding to protect all americans against Bioterriosm. Bioterriosm Preparedness Act of 2001(BioPact)S.1747 Public Health Security and Bioterriosm Response Act of 2001-H.R.3448 Liability Health Act-H.R.4600 Anti-trust Improvements-H.R.3897 Patient Safety&Quality Improvement-S.2590 J-1 Visas-S.2674

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

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.

Client expense: $122,924 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), 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

--Patient Bill of Rights,S1052 --IDEA legislation -- Help Efficient, Accessible, Low cost, Timely Health Care (HEALTH) Act of 2002 (HR 4600) IMPACT legislation - improving physical activity & nutrition to address growing epidemic of obesity

Client expense: $326,300 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Education, Dept of, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Occupational Safety & Health Administration (OSHA), Occupational Safety & Health Review Commission, SENATE, White House Office

American Hospital Preservation Act (S.839/H.R.1556);Rural & Small Community Hospital Area Wage & Base Payment Improvement Act (S.885/H.R.1609);State Budget Relief Act of 2001 (H.R.3414);Overturn Medicaid Upper Payment Limit Reduction (S.J.Res.37/H.J.Res.92);Delay Medicaid Upper Payment Limit Reduction (S.1745/H.R.3360);Medicaid Safety Net Hospital Continued Preservation Act (S.572/H.R.854);Prompt Payment of Health Benefits Claims Act (H.R.287);Helping to Ensure Affordable,Low-Cost,Timely Health Care Act of 2002(H.R.4600);Nurse Reinvestment Act (S.706/H.R.1436);Nurse of Tomorrow Act (H.R.1897);Health Information Technology & Quality Improvement Act (S.705/H.R.3292);Public Health Security & Bioterrorism Response Act of 2001 (S.1715/H.R.3448);Assure Access to Mammography Act (S.548/H.R.1354);Immigrant Children's Health Improvement Act of 2001 (S.582/H.R.1143)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2615 Medical Privacy Protection Act HHS Appropriation Bill for Medical Legislation HR 2315, HR 526, S 872 S 812 Patient's Bill of Rights S 710 Kennedy Healthcare bill HR 4600 Health Act HR 3897 Health bill

Client expense: $150,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Energy, Dept of, Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Overseas Private Investment Corp (OPIC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR), White House Office

HR 2315, HR 526, S 872 S 812 Patient's Bill of Rights S 710 Kennedy Healthcare Bill HR 4600 Health Act HR 3897 Health bill

Client expense: $150,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Energy, Dept of, Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Overseas Private Investment Corp (OPIC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR), White House Office

Fiscal Year 2003 Budget Resolution S.839,H.R.4954,H.R.1556 The American Hospital Preservation Act S.885,H.R.4954,H.R.1609 The Rural & Small Community Hospital Area Wage and Base Payment Improvement Act S.2547 The Hospital Outpatient Fair Payment Act of 2002 S.2555 The Revitalizing Under-Served Rural Areas and Localities Act S.2615,H.R.4515 The Rural Community Hospital Assistance Act S.326,H.R.4954,H.R.975 The Home Health Payment Fairness Act S.2490,H.R.4954 Medicare Skilled Nursing Beneficiary Protection Act of 2002 S.812,H.R.3414,S.2110 State Budget Relief Act of 2001 S.J.Res.37/H.J.Res.92 Resolution of Disapproval--Overturn Medicaid Upper Payment Limit Reduction S.1745,H.R.3360 Delay in Medicaid Upper Payment Limit Reduction S.572,H.R.854 Medicaid Safety Net Hospital Continued Preservation Act H.R.287 Prompt Payment of Health Benefits Claims Act H.R.4600 Helping to Ensure Affordable, Low-Cost, Timely Health Care Act of 2002 S.706,H.R.1436 The Nurse Reinvestment Act H.R.1897 The Nurse of Tomorrow Act S.705,H.R.3292 The Health Information Technology and Quality Improvement Act/Medication Errors Reduction Act of 2001 S.548,H.R.4954,H.R.1354 Assure Access to Mammography Act S.582,H.R.1143 The Immigrant Children's Health Improvement Act of 2001 S.2449 Federal Responsibility for Immigrant Health Act S.169,H.R.519 Local Medical Emergency Reimbursement Act S.1715,H.R.3448 Public Health Security and Bioterrorism Response Act of 2001 HHS Emergency Readiness Funding for Health Care Providers Disaster Relief Funding for Health Care Providers Medicare Prescription Drug Coverage & Provider Payment Increase Legislation Inpatient, Outpatient, Skilled Nursing Facility and Long Term Care Hospital (LTCH) PPS Regulations Continuation of Agriculture Department's J-1 Visa Program CMS Seventh Scope of Work for Quality Improvement Organizations CMS Outcomes-based Qulaity Improvement in Home Health Care CMS Proposed Expansion of Post-Acute Care Transfer Payment EMTALA Regulations Provider-based Regulations Corporate Compliance Department of Labor Regulations on Benefit Claim Appeals HHS Regulatory Reform Efforts IRS Intermediate Sanction Rules Upper Payment Limit Rules HIPAA Rules

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

Government targets: 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), Office of the Vice President of the United States, SENATE

PL 104-191, Health Insurance Portability and Accountability Act: advocated through formal comment process to seek changes and modifications in HIPAA with respect to treatment of patient privacy and charitable contributions;HR 3487/S.1864, Nurse Reinvestment Act:monitored progress of negotiations of informal conference committee seeking compromise;Monitored progress of Senate bill(Kennedy/Frist) and House bill, HR 4697,Human Research Subject Protections Act of 2002, which would increase the protection of participants in human subject research;S.543, Mental Health Equitable Treatment Act of 2001:monitored bill which would provide for equal coverage of mental health benefits with respect to health insurance coverage;monitored HR 2178,All-Payer Graduate Medical Education Act of 2001 (Representative Ben Cardin): a bill to provide comprehensive financing for graduate medical education;monitored HR 3236, Patient and Physician Safety and Protection Act of 2001 (Representative Conyers):to amend Title XVIII of the Social Security Act to reduce the work hours and increase the supervision of resident-physicians to ensure the safety of patients and resident-physicians themselves;monitored HR 4600, The Help Efficient, Accessible, Low Cost, Timely Health Care Act of 2001(Representative Jim 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; Provided comments to Maryland Senators in response to hearing before the Senate Health, Education, Labor and Pensions Committee (4/16/02) on proposed amendments to the Health Insurance Portabiliy and Accountability Act (HIPAA)privacy regulations.

Client expense: $140,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S2244 - Prescription Drug Parity Act, HR4833 - Accuracy in Pharmaceuticals Advertising Act, HR3448, S2692 - Reauthorization of the Prescription Drug User Fee Act, S812, HR1862 - Greater Access to Afordable Pharmaceuticals Act, S1052 - Patient Bill of Rights HR4600 - HELP Act Health Issues related to economic stimulus bills (HR3259, HR622, HR30390) HR4954, HR4832, HR490, S2625 - Prescription Drugs Generic Drugs, medical devices, drug reimportation, children's health issues

Client expense: $167,892 · Firm income: Not reported

Government targets: Consumer Product Safety Commission (CPSC), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Housing & Urban Development, Dept of (HUD), Natl Highway Traffic Safety Administration (NHTSA), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

S. 1712: "Class Action Fairness Act of 2001" Legislation to amend the procedures that apply to consideration of interstate class actions to assure fairer outcomes for class members and defendants, and for other purposes. H.R. 2341, H.Res. 367: "Class Action Fairness Act of 2002" Legislation to amend the procedures that apply to consideration of interstate class actions to assure fairer outcomes for class members and defendants, to outlaw certain practices that provide inadequate settlements for class members, to assure that attorneys do not receive a disproportionate amount of settlements at the expense of class members, to provide for clearer and simpler information in class action settlement notices, to assure prompt consideration of interstate class actions, to amend title 28, United States Code, to allow the application of the principles of Federal diversity jurisdiction to interstate class actions, and for other purposes. H.R. 4600: "Help Efficient, Accessible, Low Cost, Timely Health Care (HEALTH) Act of 2002" Legislation 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. AMDT. 4326, S. 812: Legislation to provide for health care liability reform.

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

FY'02 Appropriations (Labor/HHS/Education and VA and Medical Care funding) Flu Vaccine Availability Act of 2001 - H.R.943 Antibotic Resistance Prevention Act of 2001 - H.R.1771 Underserved Adult and Adolescent Immunization Act of 2001 - H.R.2598 Bipartisan Patient Bill of Rights-S.1052/H.R.526,H.R.2663 Federal District Court order requiring Peer Review Organizations (PROs) to release physician information. Support for funding to expand the exsisting public programs such as Medicaid and SCHIP to expand coverage for the uninsured(S.2679) Health Insurance Flexibility and Affordability (HIFA)Initative Medicare Education and Regulatory Fairness Act of 2001(MERFA)- H.R.868 Medicare Regulatory and Contracting Reform Act of 2001, S.1738 Privacy Rule-HIPAA Extension for Standard Transaction and Code Set Regulations under HIPAA Administrative Simplification Compliance Act of 2001 - S.1684,H.R.1684 COBRA Plus Act of 2001 Economic Recovery and Assistance foe American Workers Act of 2001 The Geriatric Care Act-S.775 The Disabled Veterans Service Dog and Health Care Improvement Act of 2001-H.R.2792 Funding to protect all americans againt bioterriosm Bioterrorism Preparedness Act of 2001(BioPact)-S.1747 Public Health Security and Bioterriosm Response Act of 2001-H.R.3448 Liability Health Act-H.R.4600 Anti-trust Improvements-H.R.3897 Patient Safety&Quality Improvement-S.2590 J-1 Visas - S.2674

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

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.

Client expense: $119,489 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), 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), President of the U.S., SENATE, White House Office

H.R. 1639 - Common Sense Medical Malpractice Reform Act of 2001 H.R. 2103 - Medical Malpractice Rx Act H.R. 2315 - CARE Act of 2001 H.R. 4600 - Help, Efficient, Accessible, Low Cost, Timely Health Care (HEALTH) Act of 2002

Client expense: $1,520,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Office of the Comptroller of the Currency (OCC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

HR 2615 Medical Privacy Protection Act HHS Appropriation Bill for Medical Legislation HR 2315, HR 526, S 872, S 812 Patient's Bill of Rights S 710 Kennedy Healthcare bill HR 4600 Health Act HR 3897 Health Bill

Client expense: $150,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Energy, Dept of, Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Overseas Private Investment Corp (OPIC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade & Development Agency (USTDA)

HR 2315, HR 526, S 872, S 812 Patient's Bill of Rights S 710 Kennedy Healthcare bill HR 4600 Health Act HR 3897 Health bill

Client expense: $150,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Energy, Dept of, Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Overseas Private Investment Corp (OPIC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade & Development Agency (USTDA)