Project BioShield Act of 2003

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” HR 2660, “Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2004”: Worked on the Toomey admendment, which would have altered the funding of certain NIH grant review processes. Participated in meetings with Agency for Healthcare Research and Quality and the Veterans Administration as a member of the MD/DC Electronic Health Initiative. Met with a member of the President’s Information Technology Advisory Committee. This consortium is working to create a regional electronic health record system. In addition to meeting with agency representatives, kept Senators Mikulski and Sarbanes, as well as Congressman Cardin, apprised of the group’s plans and progress. Continue to monitor legislative efforts on patient safety, quality improvement and those working to address medical liability issues.

Client expense: $380,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), 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)

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.)

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

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

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