Project BioShield Act of 2004

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)