National Knee and Hip Replacement Registry Act of 2009

H.R. 1346/S.540 - Medical Device Safety Act of 2009: to amend the Federal Food, Drug and Cosmetic Act with respect to liability under State and local requirements respecting devices. H.R. 3590 - Patient Protection and Affordable Care Act H.R. 2400 - Strategies to Address Antimicrobial Resisance Act H.R. 2813 - National Knee and Hip Replacement Registry Act of 2009 H.R. 1549/S.619 - Preservation of Antibiotics for Medical Treatment Act of 2009

Client expense: $573,687 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1346/S.540 - Medical Device Safety Act of 2009: to amend the Federal Food, Drug and Cosmetic Act with respect to liability under State and local requirements respecting devices. H.R. 3590 - Patient Protection and Affordable Care Act H.R. 2400 - Strategies to Address Antimicrobial Resisance Act H.R. 2813 - National Knee and Hip Replacement Registry Act of 2009 H.R. 1549/S.619 - Preservation of Antibiotics for Medical Treatment Act of 2009

Client expense: $439,000 · Firm income: Not reported

Medicare Inpatient Prospective Payment System ruling for FY2009/FY2010 - (provisions related to gainsharing/shared savings programs/ACE demonstration project/physician reimbursement); and S.301 Physician Payments Sunshine Act of 2009 (all provisions); (continued) S.882 Drug and Device Accountability Act of 2009 (all provisions); H.R. 1346/S. 540 Medical Device Safety Act of 2009 (provisions related to federal pre-emptionof state laws re Class III devices) H.R. 1 Recovery Act of 2009 (provisions related to comparative effectiveness research); H.R. 2502 Comparative Effectiveness Research Act of 2009 (all provisions); H.R. 2813 National Hip and Knee Replacement Registry Act of 2009 (all provisions); S.1213 Patient-Centered Outcomes Research Act of 2009 (provisions related to stakeholder involvement in setting research agenda)

Client expense: $110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2813 National Hip and Knee Replacement registry Act of 2009 (all provisions); S.301 Physician Payments sunshine Act of 2009 (all provisions); S.882 Drug and device Accountability act of 2009 (all provisions); H.R. 1346/S. 540 Medical device safety Act of 2009 (all provisions related to federal pre-emption of state laws with respect to Class III devices; H.R. 1 Recovery Act of 2009 (all provisions related to comparative effectiveness research); H.R. 2502 Comparative Effectiveness research Act of 2009 9all provisions); H.R. 2813 National Hip and Knee Replacement Registry Act of 2009 (all provisions); S. 1213 Patient-Centered Outcomes Research Act of 2009 (prov. related to stakeholder involvement in setting research agenda); H.R. 3200 America's Affordable Health Choices Act of 2009 (prov. related to comparative effectiveness (stakeholder involvement), physician reimbursement, physician disclosure/sunshine, national device registry); America's Healthy Future Act; Chairman's Mark (provisions related to device excise tax, comparative effectiveness, physician reimbursement, physician disclosure/sunshine; S. 1213 Patient-Centered Outcomes Act of 2009 (provisions related to stakeholder involvement); H.R. 3962 and S. 1796 (later known as H.R. 3590) (prov. related to excise tax on medical device companies, compensation of specialist physicians, Medicare payement reform, comparative effectiveness, and physician payment disclosures.

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

HR 1346/S.540 Medical Device Safety Act of 2009 - To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. [Elizabeth Sharp, Brett Loper, Elizabeth Kegler, Julie Cohen] H.R.1032/S.422 Heart Disease Education, Analysis Research, and Treatment for Women Act - To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.[Elizabeth Sharp] H.R. 2813 To establish a national knee and hip replacement registry. [Julie Cohen, Elizabeth Kegler] H.R.759 Food and Drug Administration Globalization Act of 2009 - To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food, drugs, devices, and cosmetics in the global market, and for other purposes.[Brett Loper, Elizabeth Sharp] S.510 FDA Food Safety Modernization Act - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply.[Brett Loper, Elizabeth Sharp] H.R. 2749 To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes. [Elizabeth Sharp, Brett Loper] S. 717 A bill to modernize cancer research, increase access to preventative cancer services, provide cancer treatment and survivorship initiatives, and for other purposes. [Elizabeth Sharp, Brett Loper] S. 882 A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes. [Elizabeth Sharp, Brett Loper] Issues related to the 510(k) process for the approval of medical devices [Brett Loper, Elizabeth Sharp]

Client expense: $610,740 · Firm income: Not reported

HR 2502 and S. 1213 to provide for conduct of comparative effectiveness research; HR 2813 - support of establishment of knee and hip replacement registry.

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1346/S.540 Medical Device Safety Act of 2009 - To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. [Elizabeth Sharp, Brett Loper, Elizabeth Kegler, Julie Cohen] H.R.1032/S.422 Heart Disease Education, Analysis Research, and Treatment for Women Act - To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.[Elizabeth Sharp] H.R. 2813 To establish a national knee and hip replacement registry. [Julie Cohen, Elizabeth Kegler] H.R.759 Food and Drug Administration Globalization Act of 2009 - To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food, drugs, devices, and cosmetics in the global market, and for other purposes.[Brett Loper, Elizabeth Sharp] S.510 FDA Food Safety Modernization Act - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply.[Brett Loper, Elizabeth Sharp] H.R. 2749 To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes. [Elizabeth Sharp, Brett Loper] S. 717 A bill to modernize cancer research, increase access to preventative cancer services, provide cancer treatment and survivorship initiatives, and for other purposes. [Elizabeth Sharp, Brett Loper] S. 882 A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes. [Elizabeth Sharp, Brett Loper] Issues related to the 510(k) process for the approval of medical devices [Brett Loper, Elizabeth Sharp]

Client expense: $380,324 · Firm income: Not reported

National Joint Registry (HR 2813), FDA 510(k) issues, H Res 577 (Orthopedic Resolution) Various health care reform draft bills from the House Tri-Committees and Senate HELP and Finance Committees

Client expense: $23,476 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

HR 2813 To establish a national knee and hip replacement registry.

Client expense: $220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1346/S540, The Medical Device Safety Act of 2009 HR 2813, The National Knee and Hip Replacement Registry Act of 2009 Reform of the 510(k) regulatory pathway Statement for the record on arthritis and related procedures

Client expense: $49,195 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2502 and S. 1213 to provide for conduct of comparative effectiveness research; HR 2813 - support of establishment of knee and hip replacement registry.

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE