Human Research Subject Protections 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.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

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