Government Accountability Office Act of 2008

Outpatient Prospective Payment Service S. 3101: Medicare Improvements for Patients and Providers Act of 2008 Medicaid Rebates H.R. 1424 H.R. 6331 H.R. 3162 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Access to Drug Pricing Data H.R. 5683

Client expense: $1,920,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

MMM (Legislative Issues): H.R. 4: Medicare Prescription Drug Price Negotiation Act (Dingell); H.R. 976: Childrens Health Insurance Program Reauthorization Act (Rangel) (continued) H.R. 1990: Medicare Cost Contract Extension and Refinement Act (Pomeroy); H.R. 2945: Medicare Advantage Truth in Advertising Act (Stark); H.R. 3025: Medicare Prescription Drug Savings for Our Seniors Act (Doggett); H.R. 3061: Medicare Part D Drug Class Protection Act (Doggett); H.R. 3162: Childrens Health and Medicare Protection Act (Dingell); H.R. 3932: Medicare Prescription Drug Savings and Choice Act (Berry); H.R. 3963: Childrens Health Insurance Program Reauthorization Act (Dingell); H.R. 4296: Medicare Electronic Medication and Safety Protection Act (Schwartz); H.R. 5268: Medicaid FMAP (Pallone); H.R. 5480: Medicare Funding Warning Response Act (Hoyer-Boehner); H.R. 5613: Protecting the Medicaid Safety Net Act (Dingell); H.R. 5683: GAO Act (provisions relating to access to Medicare part C/part D data) (Davis); H.R. 5998: Protecting Children's Health Coverage Act (Pallone); H.R. 6331: Medicare Improvements for Patients and Providers Act (provisions relating to Medicare Advantage, Medicare Part D, Medigap, Medicaid, health care disparities, and electronic prescribing) (Rangel-Dingell); H.R. 6388: GAO Improvement Act (provisions relating to access to Medicare part C/part D data) (Waxman); H.R. 6359: Medicare Beneficiary Protection Act (Biggert); H.R. 6365: Medicare Special Needs Plans Extension and Amendments Act (Kind); H.R. 7077: QI Program Supplemental Funding Act (Dingell) (provisions relating to cost sharing assistance for low-income Medicare beneficiaries); H.R. 7197: Medicare Advantage Funding (Gonzalez) (provisions relating to limiting increases in Medicare Advantage payment rates); H.Res. 1368 (provisions relating to Medicare Funding Warning); S. 3: Medicare Prescription Drug Price Negotiation Act (Reid); S. 130: Medicare Cost Contract Extension and Refinement Act (Allard); S. 706: Medicare Advantage Stabilization Fund (Feingold); S. 799: Community Choice Act (Harkin); S. 1102: Part D Equity for Low-Income Seniors Act (Bingaman); S. 1103: Helping Fill the Medicare Rx Gap Act (Bingaman); S. 1107: Home and Community Services Copayment Equity Act (Smith); S. 1108: Medicare Part D Outreach and Enrollment Enhancement Act (Smith); S. 1200: Indian Health Care Improvement Act (includes Medicaid/MA provisions); S. 1507: Access to Medicare Data Act (Grassley); S. 1544: Medicare Quality Enhancement Act (Gregg); S. 1589: Drug Rebate Equalization Act (Bingaman) (provisions relating to Medicaid drug rebates); S. 1827: Pharmacist Access and Recognition in Medicare Act (Cochran); S. 1893: Childrens Health Insurance Program Reauthorization Act (Baucus); S. 1954: Pharmacy Access Improvement Act (Baucus); S. 2219: Medicare Prescription Drug Savings and Choice Act (Durbin); S. 2408: Medicare Electronic Medication and Safety Protection Act (Kerry); S. 2620: Medicaid FMAP (Rockefeller); S. 2662: Medicare Funding Warning Response Act (Baucus-Gregg); S. 2795: Small Business Health Options Program Act (Durbin-Snowe); S. 2819: Economic Recovery in Health Care Act (provisions relating to Medicaid funding) (Rockefeller); S. 3101: Medicare Improvements for Patients and Providers Act (provisions relating to Medicare Advantage, Medicare Part D, Medigap, Medicaid, health care disparities, electronic prescribing) (Baucus); S. 3560: QI Program Supplemental Funding Act (Baucus) (provisions relating to cost sharing assistance for low-income Medicare beneficiaries); S. 3604: Emergency Supplemental Appropriations Act (provisions relating to Medicaid FMAP); S. 3656: Preserving Access to Healthcare Act (Schumer) (provisions relating to Medicare and Medicaid regulation); S. 3869: Economic Stimulus (Reid) (provisions relating to Medicaid FMAP and Medicaidd MCO provider taxes); S. 3710: Medicare Early Access Act (Rockefeller) (provisions relating to Medicare "buy-in" option); and S.J.Res. 44 (provisions relating to blocking implementation of SCHIP requirements). MMM (Regulatory Issues) Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology and data issues, (including audit and encounter data issues), bidding and payment issues (including MA coding intensity, Part D reinsurance, low income subsidies, application process, and audits), application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, SSA and CMS premium withhold processing issues, enrollment rules, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff, measurement and oversight of plan performance including Special Needs Plans (SNPs); quality meaasures, grievance and appeals processes, compliance/fraud and abuse training, and Medicare/Medicaid integration issues for Special Needs Plans (SNPs); Federal premption of State authority over MA and Part D plans, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, and other operational issues; Medicare creditable drug coverage reporting requirements; implementation issues for the Medicare Retiree Drug Subsidy program; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education program; ongoing implementation issues for the Medicare cost plan program including enrollment, marketing materials review and approval and other operational issues, MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting inititiative; issues relating to Medicare coverage policy and national coverage decisions; Medicare clinical trials; Medicaid managed care regulations and policies, including the Medicaid managed care actuarial soundness standard, quality oversight, grievance and appeals processes, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost/rebate issues affecting Medicaid health plans; health plan-related State Childrens Health Insurance Program (SCHIP) issues, including eligibility and outreach issues; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including documentation of citizenship requirements, state benefit flexibility options, and Medicaid managed care organization provider tax issues; standards for electronic prescribing; and health information technology standards and policies.

**see addendum page Human Growth Hormone Regulation S. 877/H.R. 4911 - the Controlling the Abuse of Presciptions Act of 2007 Biosimilars H.R. 1956 - Patient Protection and Innovative Biologic Medicine Act of 2007 H.R. 1038 - Access to Life-Saving Medicine Act, Follow-On Biologics S. 1695 - Biologics Price Competition and Innovation Act of 2007 H.R. 5629 - the Pathway for Biosimilars Act S. 2029 - Physician Payments Sunshine Act of 2007, disclosure H.R. 5605 - Physician Payments Sunshine Act of 2008, disclosure H.R. 5683 - Government Accountability Office Act of 2008

Client expense: Not reported · Firm income: $70,000

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

Medicare Advantage program - Proposed legislation concerning this issue. Medicare/Medicaid issues - HR 4, Medicare Prescription Drug Price Negotiation Act of 2007; S 3, Medicare Prescription Drug Price Negotiation Act of 2007; S 1102, Part D Equity for Low-Income Seniors Act of 2007; S 1103, Helping Fill the Medicare Rx Gap Act of 2007; S 1107, Home and Community Services Copayment Equity Act of 2007; S 1108, Medicare Part D Outreach and Enrollment Enhancement Act of 2007; HR 2945, Medicare Advantage Truth in Advertising Act of 2007; S 799, Community Choice Act of 2007; S 1544, Medicare Quality Enhancement Act of 2007; S 1507, Access to Medicare Data Act of 2007; S 1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; HR 3025, Medicare Prescription Drug Savings for Our Seniors (Medicare Prescription Drug SOS) Act of 2007; HR 3061, Medicare Part D Drug Class Protection Act of 2007; HR 3162, Children's Health and Medicare Protection Act of 2007; HR 976, Children's Health Insurance Program Reauthorization Act of 2007; S 1893, Children's Health Insurance Program Reauthorization Act of 2007; S 1954, Pharmacy Access Improvement (PhAIm) Act of 2007; HR 3963, Children's Health Insurance Program Reauthorization Act of 2007; S 2219, Medicare Prescription Drug Savings and Choice Act of 2007; HR 3932, Medicare Prescription Drug Savings and Choice Act of 2007; S 2408, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; HR 4296, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; S 1200, Indian Health Care Improvement Act Amendments of 2008; HR 5480, Medicare Funding Warning Response Act of 2008; S 2662, Medicare Funding Warning Response Act of 2008; HR 5268, To provide for a temporary increase of the Federal medical assistance percentage under the Medicaid Program; HR 6388, Government Accountability Office Improvement Act of 2008; HR 5998, Fair and Justifiable Credit Card Interest Rate Act of 2008; S 2819, Economic Recovery in Health Care Act of 2008; HR 6359, Medicare Beneficiary Protection Act of 2008; HR 6365, Medicare Special Needs Plans Extension and Amendments Act of 2008; HR 5613, Protecting the Medicaid Safety Net Act of 2008; S 2620, To provide for a temporary increase of the Federal medical assistance percentage under the Medicaid program; HR 5683, Government Accountability Office Act of 2008; HR 7110, Job Creation and Unemployment Relief Act of 2008; S 3560, QI Program Supplemental Funding Act of 2008; HR 7077, QI Program Supplemental Funding Act of 2008; S 3604, Emergency Supplemental; HR 7197, To amend part C of title XVIII of the Social Security Act to limit increases in Medicare Advantage payment rates; S 3656, Preserving Access to Healthcare (PATH) Act of 2008; S 3689, Economic Stimulus; S 3710, Medicare Early Access Act of 2008; S 3101, Medicare Improvements for Patients and Providers Act of 2008.

Issues related to drug coverage including pharmacy payments, reimbursement, competition and plan administration; Health Information Technology with respect to data privacy and electronic prescribing of prescription drugs; Promotion of competition in the prescription drug marketplace including the drug approval process; Additional Issues - see addendum Issues related to drug coverage including pharmacy payments, reimbursement, competition and plan administration HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; HR 3140 - Saving Our Community Pharmacies Act of 2007 HR 3193 - Access to Community Pharmacy Preservation Act of 2007 S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007 S 2161 - Community Pharmacy Fairness Act of 2007 Health information technology with respect to data privacy and electronic prescribing of prescription drugs HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 HR 3800 - Promoting Health Information Technology Act HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008 HR 6898 - Health e-Information Technology Act S 1408 - Health Information Technology Act of 2007 S 1693 - Wired for Health Care Quality Act S. 1814 - Health Information Privacy and Security Act Promotion of competition in the prescription drug marketplace including the drug approval process HR 1432 and S. 316 - Preserve Access to Affordable Generics Act HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 HR 5629 - Pathway for Biosimilars Act S 28 - Generics First Act of 2007 S 1695 - Biologics Price Competition and Innovation Act of 2007 HR 1038 / S 623 - Access to Life-Saving Medicine Act S 316 Preserve Access to Affordable Generics Act HR 1505 / S 1695 Affordable Biologics for Consumers Act HR 5629 - Pathway for Biosimilars Act Additional Issues HR 5683 - Government Accountability Office Act of 2008 S 1507 - Access to Medicare Data Act of 2007 S 273 - Prescription Drug and Health Improvement Act of 2007 HR 3610 - Food and Drug Import Safety Act of 2007

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) S: 3230: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Vaccine Financing National Vaccine Advisory Committee Draft Recommendations Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP + 4% Proposed Regulation In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 S.3408 Medicare/Medicaid Packages Human Subject Protections in Clinical Trials International Market Access for U.S. Healthcare Products Alliance for Healthcare Competitiveness Funding for National Institutes of Health S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008 Funding for Bioterrorism and Emergency Preparedness S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008 Funding for Pandemic Influenza Preparedness S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008 Funding for the Food and Drug Administration S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008 Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation S.3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 S. 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

False Claims Act Amendment S.2041 H.R. 4854 . Access to Drug Pricing Data H.R. 5683

Client expense: $1,920,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Drug Importation S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence European Union Low Level Presence Physician Payments Sunshine Act S.2029 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking S: 3289: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 6432 Access to Drug Pricing Data H.R. 5683 Funding for Food Safety at the Food and Drug Administration S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for FY 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008 Human Subject Protections in Clinical Trials Human Growth Hormone Regulation S.877

Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP+ 4% Proposed Regulation Medicaid Rebates H.R. 1424 H.R. 6331 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Access to Drug Pricing Data H.R. 5683

Client expense: $1,920,000 · Firm income: Not reported

Access to Drug Pricing Data H.R. 5683 Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 S.3408 Medicare/Medicaid Packages Medicaid Rebates H.R. 1424 H.R. 6331 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP+ 4% Proposed Regulation Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Drug Importation S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008

Client expense: $1,920,000 · Firm income: Not reported

**see addendum page Human Growth Hormone Regulation S. 877/H.R. 4911 - the Controlling the Abuse of Prescriptions Act of 2007 Biosimilars H.R. 1956 - Patient Protection and Innovative Biologic Medicine Act of 2007 H.R. 1038 - Access to Life-Saving Medicine Act, Follow-On Biologics S. 1695 - Biologics Price Competition and Innovation Act of 2007 H.R. 5629 - the Pathway for Biosimilars Act S. 2029 - Physician Payments Sunshine Act of 2007, disclosure H.R. 5605 - Physician Payments Sunshine Act of 2008, disclosure H.R. 5683 - Government Accountability Office Act of 2008

Client expense: Not reported · Firm income: $70,000

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

Issues related to drug coverage including pharmacy payments, reimbursement, competition and plan administration; Health Information Technology with respect to data privacy and electronic prescribing of prescription drugs; Promotion of competition in the prescription drug marketplace including the drug approval process; Additional Issues - see addendum Issues related to drug coverage including pharmacy payments, reimbursement, competition and plan administration HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; HR 3140 - Saving Our Community Pharmacies Act of 2007 HR 3193 - Access to Community Pharmacy Preservation Act of 2007 S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007 S 2161 - Community Pharmacy Fairness Act of 2007 Health information technology with respect to data privacy and electronic prescribing of prescription drugs HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 HR 3800 - Promoting Health Information Technology Act HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008 HR 6898 - Health e-Information Technology Act S 1408 - Health Information Technology Act of 2007 S 1693 - Wired for Health Care Quality Act S. 1814 - Health Information Privacy and Security Act Promotion of competition in the prescription drug marketplace including the drug approval process HR 1432 and S. 316 - Preserve Access to Affordable Generics Act HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 HR 5629 - Pathway for Biosimilars Act S 28 - Generics First Act of 2007 S 1695 - Biologics Price Competition and Innovation Act of 2007 HR 1038 / S 623 - Access to Life-Saving Medicine Act S 316 Preserve Access to Affordable Generics Act HR 1505 / S 1695 Affordable Biologics for Consumers Act HR 5629 - Pathway for Biosimilars Act Additional Issues HR 5683 - Government Accountability Office Act of 2008 S 1507 - Access to Medicare Data Act of 2007 S 273 - Prescription Drug and Health Improvement Act of 2007 HR 3610 - Food and Drug Import Safety Act of 2007

H.R. 4, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues H.R. 758, Price Disclosure Regarding Treatment of Breast Cancer: transparency H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007: Medicaid rebate H.R. 2184, Enhanced Health Care Value for All Act of 2007: comparative effectiveness H.R. 3162, Children's Health and Medicare Protection Act of 2007: Medicaid rebate H.R. 4854, False Claims Act Correction Act of 2007: liability issues H.R. 5605, Physician Payments Sunshine Act of 2008: transparency issues H.R. 5683, The Government Accountability Office Act: disclosure of data H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008: comparative effectiveness, federal upper limit for Medicaid pharmacy reimbursement, electronic prescribing, Part D data disclosure, and other issues H.R. 6388 The Government Accountability Office Improvement Act of 2008: disclosure of data H.R. 6684, Medicare Prescription Drug Cost Equalization Act: Part D issues H.R. 6752, The Independent Drug Education and Outreach Act of 2008: direct to physician marketing S. 3, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues S. 558, Mental Health Parity Act of 2007: health insurance issues S. 2029, Physician Payments Sunshine Act of 2007: transparency issues S. 2041, False Claims Act Correction Act of 2007: liability issues S.3101, Medicare Improvements for Patients and Providers Act of 2008: comparative effectiveness, federal upper limit for Medicaid pharmacy reimbursement, electronic prescribing, Part D data disclosure, and other issues S. 3118, Preserving Access to Medicare Act of 2008: electronic prescribing, Part D data disclosure, and other issues S. 3396, The Independent Drug Education and Outreach Act of 2008: direct to physician marketing S. 3408, Comparative Effectiveness Research Act of 2008: comparative effectiveness

H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1014, Heart Disease Education, Analysis Research, and Treatment for Women Act: reporting and analysis of patient data H.R. 1038, Access to Life-Saving Medicine Act: follow-on biologics H.R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007: follow-on biologics H.R. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5501, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5683, The Government Accountability Office Act: disclosure of data H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008: direct-to-consumer drug advertising H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008: on-line pharmacy issues H.R. 6378, Strengthening of FDA Integrity Act of 2008: debarment H.R. 6381, Medical Device Safety Act of 2008: preemption issues H.R. 6388 The Government Accountability Office Improvement Act of 2008: disclosure of data H.R. 6432, Animal Drug User Fee Amendments of 2008: technical corrections to FDAAA H.R. 6820, Water Assessment and Treatment Evaluation Research Study Act of 2008: pharmaceuticals in drinking water and human health S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 2731, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues S. 3398, Medical Device Safety Act of 2008: preemption issues S. 3409, Drug and Device Accountability Act of 2008: import safety S. 3560, QI Program Supplemental Funding Act of 2008: antibiotic exclusivity provisions S. 3633, Transparency in Drug Labeling Act: country of origin labeling for drugs

Medicare Advantage - HR 6331, Medicare Improvements for Patients and Providers Act of 2008; Proposed legislation re this issue. Medigap insurance market issues - Proposed legislation re these issues. Medicare/Medicaid issues - S 706, To amend title XVIII of the Social Security Act to repeal the MA Regional Plan Stabilization Fund; S 130, Medicare Cost Contract Extension and Refinement Act of 2007; HR 1990, Medicare Cost Contract Extension and Refinement Act of 2007; HR 4, Medicare Prescription Drug Price Negotiation Act of 2007; S 3, Medicare Prescription Drug Price Negotiation Act of 2007; S 1102, Part D Equity for Low-Income Seniors Act of 2007; S 1103, Helping Fill the Medicare Rx Gap Act of 2007; S 1107, Home and Community Services Copayment Equity Act of 2007; S 1108, Medicare Part D Outreach and Enrollment Enhancement Act of 2007; HR 2945, Medicare Advantage Truth in Advertising Act of 2007; S 799, Community Choice Act of 2007; S 1544, Medicare Quality Enhancement Act of 2007; S 1507, Access to Medicare Data Act of 2007; S 1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; HR 3025, Medicare Prescription Drug Savings for Our Seniors (Medicare Prescription Drug SOS) Act of 2007; HR 3061, Medicare Part D Drug Class Protection Act of 2007; HR 3162, Children's Health and Medicare Protection Act of 2007; HR 976, Children's Health Insurance Program Reauthorization Act of 2007; S 1893, Children's Health Insurance Program Reauthorization Act of 2007; S 1954, Pharmacy Access Improvement (PhAIm) Act of 2007; HR 3963, Children's Health Insurance Program Reauthorization Act of 2007; S 2219, Medicare Prescription Drug Savings and Choice Act of 2007; HR 3932, Medicare Prescription Drug Savings and Choice Act of 2007; S 2408, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; HR 4296, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; S 1200, Indian Health Care Improvement Act Amendments of 2008; HR 5480, Medicare Funding Warning Response Act of 2008; S 2662, Medicare Funding Warning Response Act of 2008; HR 5268, To provide for a temporary increase of the Federal medical assistance percentage under the Medicaid Program; HR 6388, Government Accountability Office Improvement Act of 2008; HR 5998, Fair and Justifiable Credit Card Interest Rate Act of 2008; S 2819, Economic Recovery in Health Care Act of 2008; HR 6359, Medicare Beneficiary Protection Act of 2008; HR 6365, Medicare Special Needs Plans Extension and Amendments Act of 2008; HR 5613, Protecting the Medicaid Safety Net Act of 2008; S 2620, To provide for a temporary increase of the Federal medical assistance percentage under the Medicaid program; S 3101, Medicare Improvements for Patients and Providers Act of 2008; HR 5683, Government Accountability Office Act of 2008; HR 7110, Job Creation and Unemployment Relief Act of 2008; S 3560, QI Program Supplemental Funding Act of 2008; HR 7077, QI Program Supplemental Funding Act of 2008; SJRes 44, blocking implementation of SCHIP; HRes 1368, Resolved, That section 803 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 shall not apply during the remainder of the 110th Congress; S 3604, Emergency Supplemental.

MMM (Legislative Issues): H.R. 4: Medicare Prescription Drug Price Negotiation Act (Dingell); H.R. 976: Childrens Health Insurance Program Reauthorization Act (Rangel) (continued) H.R. 1990: Medicare Cost Contract Extension and Refinement Act (Pomeroy); H.R. 2945: Medicare Advantage Truth in Advertising Act (Stark); H.R. 3025: Medicare Prescription Drug Savings for Our Seniors Act (Doggett); H.R. 3061: Medicare Part D Drug Class Protection Act (Doggett); H.R. 3162: Childrens Health and Medicare Protection Act (Dingell); H.R. 3932: Medicare Prescription Drug Savings and Choice Act (Berry); H.R. 3963: Childrens Health Insurance Program Reauthorization Act (Dingell); H.R. 4296: Medicare Electronic Medication and Safety Protection Act (Schwartz); H.R. 5268: Medicaid FMAP (Pallone); H.R. 5480: Medicare Funding Warning Response Act (Hoyer-Boehner); H.R. 5613: Protecting the Medicaid Safety Net Act (Dingell); H.R. 5683: GAO Act (provisions relating to access to Medicare part C/part D data) (Davis); H.R. 5998: Protecting Children's Health Coverage Act (Pallone); H.R. 6331: Medicare Improvements for Patients and Providers Act (provisions relating to Medicare Advantage, Medicare Part D, Medigap, Medicaid, health care disparities, and electronic prescribing) (Rangel-Dingell); H.R. 6388: GAO Improvement Act (provisions relating to access to Medicare part C/part D data) (Waxman); H.R. 6359: Medicare Beneficiary Protection Act (Biggert); H.R. 6365: Medicare Special Needs Plans Extension and Amendments Act (Kind); H.R. 7077: QI Program Supplemental Funding Act (Dingell) (provisions relating to cost sharing assistance for low-income Medicare beneficiaries); H.Res. 1368 (provisions relating to Medicare Funding Warning); S. 3: Medicare Prescription Drug Price Negotiation Act (Reid); S. 130: Medicare Cost Contract Extension and Refinement Act (Allard); S. 706: Medicare Advantage Stabilization Fund (Feingold); S. 799: Community Choice Act (Harkin); S. 1102: Part D Equity for Low-Income Seniors Act (Bingaman); S. 1103: Helping Fill the Medicare Rx Gap Act (Bingaman); S. 1107: Home and Community Services Copayment Equity Act (Smith); S. 1108: Medicare Part D Outreach and Enrollment Enhancement Act (Smith); S. 1200: Indian Health Care Improvement Act (includes Medicaid/MA provisions); S. 1507: Access to Medicare Data Act (Grassley); S. 1544: Medicare Quality Enhancement Act (Gregg); S. 1827: Pharmacist Access and Recognition in Medicare Act (Cochran); S. 1893: Childrens Health Insurance Program Reauthorization Act (Baucus); S. 1954: Pharmacy Access Improvement Act (Baucus); S. 2219: Medicare Prescription Drug Savings and Choice Act (Durbin); S. 2408: Medicare Electronic Medication and Safety Protection Act (Kerry); S. 2620: Medicaid FMAP (Rockefeller); S. 2662: Medicare Funding Warning Response Act (Baucus-Gregg); S. 2795: Small Business Health Options Program Act (Durbin-Snowe); S. 2819: Economic Recovery in Health Care Act (provisions relating to Medicaid funding) (Rockefeller); S. 3101: Medicare Improvements for Patients and Providers Act (provisions relating to Medicare Advantage, Medicare Part D, Medigap, Medicaid, health care disparities, electronic prescribing) (Baucus); S. 3560: QI Program Supplemental Funding Act (Baucus) (provisions relating to cost sharing assistance for low-income Medicare beneficiaries); S. 3604: Emergency Supplemental Appropriations Act (provisions relating to Medicaid FMAP); and S.J.Res. 44 (provisions relating to blocking implementation of SCHIP requirements). MMM (Regulatory Issues) Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology and data issues, (including audit and encounter data issues) bidding and payment issues (including MA coding intensity, Part D reinsurance, low income subsidies, application process, and audits), application process, and audits, benefit design rules, SSA and CMS premium withhold processing issues, systems issues affecting enrollment and disenrollment processing, enrollment rules, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff, measurement and oversight of plan performance including Special Needs Plans (SNPs); grievance and appeals processes, compliance/fraud and abuse training, and Medicare/Medicaid integration issues for Special Needs Plans (SNPs); Federal premption of State authority over MA and Part D plans, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, and other operational issues; Medicare creditable drug coverage reporting requirements; implementation issues for the Medicare Retiree Drug Subsidy program; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education program; ongoing implementation issues for the Medicare cost plan program including enrollment, marketing materials review and approval, systems issues affecting enrollment and disenrollment processing, payment and other operational issues; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting inititiative; issues relating to Medicare coverage policy and national coverage decisions; Medicare clinical trials; Medicaid managed care regulations and policies, including the Medicaid managed care actuarial soundness standard, quality oversight, grievance and appeals processes, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost/rebate issues affecting Medicaid health plans; health plan-related State Childrens Health Insurance Program (SCHIP) issues, including eligibility and outreach issues; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including documentation of citizenship requirements, state benefit flexibility options, and Medicaid managed care organization provider tax issues; standards for electronic prescribing; and health information technology standards and policies.

Monitored the following legislation: H.R. 3033, Contractors and Federal Spending Accountability Act of 2008. H.R. 3928, Government Contractor Accountability and Transparency Act. H.R. 4881, Contracting and Tax Accountability Act of 2008. Monitored the following legislation (cont'd): H.R. 5658, National Defense Authorization Act for FY 09. H.R. 5683, To make certain reforms with respect to the Government Accountability Office. H.R. 5959, Intelligence Authorization Act for FY09. H.R. 6221, Improving Veteran's Opportunities in Education and Business Act. H.R. 6780, No FEAR II. S. 2041, False Claims Correction Act of 2007. S. 2394, Good Government Contractor Act of 2007. S. 2904, Contractors and Federal Spending Accountability Act of 2008. S. 2905, Close the Contractor Fraud Loophole Act. S. 2916, Guaranteeing Real Accountability in Federal Transactions Act. S. 2996, Intelligence Authorization Act for FY09. S. 3001, National Defense Authorization Act for FY 09. Monitor federal and legislative activity related to Native American interests in Small Business Administration programs, federal procurement programs, and corporate governance.

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

Health Information Technology, Electronic Prescribing, Inappropriate use of Human Growth Hormone, Comparative Effectiveness, 340B Program, Confidentiality of Health Information, Generic Drugs, Generic Biologics, Internet Pharmacies, Carve-out of Generic Drugs from State Generic Substitution Laws HR 971 and S 885 - Community Pharmacy Fairness Act of 2007; all aspects HR 1432 and S. 316 - Preserve Access to Affordable Generics Act; all aspects HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; all aspects HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007; all aspects HR 2567 and S 870 - Medicare Home Infusion Therapy Coverage Act of 2007; all aspects HR 2606 and S 1376 - 340B Program Improvement and Integrity Act of 2007; all aspects HR 2914 - Medicare IVIG Access Act of 2007; all aspects HR 2970 - Pharmacy Benefit Manager Transparency Act of 2007; all aspects HR 3140 - Saving Our Community Pharmacies Act of 2007; all aspects HR 3090 - Patient and Pharmacy Protection Act of 2007; all aspects HR 3193 - Access to Community Pharmacy Preservation Act of 2007; all aspects HR 3800 - Promoting Health Information Technology Act; all aspects HR 3932 - Medicare Prescription Drug Savings and Choice Act of 2007; all aspects HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; all aspects HR 5629 - Pathway for Biosimilars Act; all aspects HR 5683 - Government Accountability Office Act of 2008, section 721 HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008; all aspects HR 6898 - Health e-Information Technology Act; all aspects S 28 - Generics First Act of 2007; all aspects S 242 - Pharmaceutical Market Access and Drug Safety Act of 2007; all aspects S 251 - Pharmaceutical Market Access Act of 2007; all aspects S 273 - Prescription Drug and Health Improvement Act of 2007; all aspects S 596 - Safe Internet Pharmacy Act of 2007; section 511(c) S 976 - Genomics and Personalized Medicine Act of 2007; all aspects S 980 - Ryan Haight Online Pharmacy Consumer Protection Act of 2007; all aspects S 1408 - Health Information Technology Act of 2007; all aspects S 1507 - Access to Medicare Data Act of 2007; all aspects S 1693 - Wired for Health Care Quality Act; all aspects S 1695 - Biologics Price Competition and Innovation Act of 2007; all aspects S. 1814 - Health Information Privacy and Security Act; all aspects S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007; all aspects S 2161 - Community Pharmacy Fairness Act of 2007; all aspects

HR 1432 and S. 316 - Preserve Access to Affordable Generics Act; all aspects HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; all aspects HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007; all aspects HR 2567 and S 870 - Medicare Home Infusion Therapy Coverage Act of 2007; all aspects HR 2606 and S 1376 - 340B Program Improvement and Integrity Act of 2007; all aspects HR 2914 - Medicare IVIG Access Act of 2007; all aspects HR 2970 - Pharmacy Benefit Manager Transparency Act of 2007; all aspects HR 3140 - Saving Our Community Pharmacies Act of 2007; all aspects HR 3090 - Patient and Pharmacy Protection Act of 2007; all aspects HR 3193 - Access to Community Pharmacy Preservation Act of 2007; all aspects HR 3800 - Promoting Health Information Technology Act; all aspects HR 3932 - Medicare Prescription Drug Savings and Choice Act of 2007; all aspects HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; all aspects HR 5629 - Pathway for Biosimilars Act; all aspects HR 5683 - Government Accountability Office Act of 2008, section 721 HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008; all aspects HR 6898 - Health e-Information Technology Act; all aspects S 28 - Generics First Act of 2007; all aspects S 242 - Pharmaceutical Market Access and Drug Safety Act of 2007; all aspects S 251 - Pharmaceutical Market Access Act of 2007; all aspects S 273 - Prescription Drug and Health Improvement Act of 2007; all aspects S 596 - Safe Internet Pharmacy Act of 2007; section 511(c) S 976 - Genomics and Personalized Medicine Act of 2007; all aspects S 980 - Ryan Haight Online Pharmacy Consumer Protection Act of 2007; all aspects S 1408 - Health Information Technology Act of 2007; all aspects S 1507 - Access to Medicare Data Act of 2007; all aspects S 1693 - Wired for Health Care Quality Act; all aspects S 1695 - Biologics Price Competition and Innovation Act of 2007; all aspects S. 1814 - Health Information Privacy and Security Act; all aspects S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007; all aspects S 2161 - Community Pharmacy Fairness Act of 2007; all aspects

Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages Medicaid Rebates H.R. 1424 H.R. 6331 H.R. 3162 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Access to Drug Pricing Data H.R. 5683 Influenza Vaccine Supply and Immunization Recommendations Outpatient Prospective Payment Service S. 3101: Medicare Improvements for Patients and Providers Act of 2008 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 (S.3181) Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination Counterfeit Drugs H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007

Client expense: $1,920,000 · Firm income: Not reported

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination Counterfeit Drugs FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 6331 H.R. 3162 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 H.R. 4911 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Vaccine Financing National Vaccine Advisory Committee Draft Recommendations Vaccines for Children Program National Vaccine Advisory Committee Draft Recommendations Influenza Vaccine Supply and Immunization Recommendations Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Patient Services S. 3101: Medicare Improvements for Patients and Providers Act of 2008 In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Alliance for Healthcare Competitiveness Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) FY 2008 Supplemental Appropriations Bill (H.R. 2642) Access to Investigation Drugs for Seriously Ill Patents The Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (S.1956) Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FDA Debarment H.R. 6378: The Strengthening of FDA Integrity Act Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

False Claims Act Amendment S.2041 FDA Debarment H.R. 6378: The Strengthening of FDA Integrity Act Access to Drug Pricing Data H.R. 5683

Client expense: $1,920,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Outpatient Prospective Payment Service S. 3101: Medicare Improvements for Patients and Providers Act of 2008 Medicaid Rebates H.R. 1424 H.R. 6331 H.R. 3162 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Access to Drug Pricing Data H.R. 5683

Client expense: $1,920,000 · Firm income: Not reported

Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals H. R. 6432 Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination Counterfeit Drugs H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 (S.3181) Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Physician Payments Sunshine Act S.2029 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S.2663 Access to Drug Pricing Data H.R. 5683 Funding for Food Safety at the Food and Drug Administration Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642)

MMM (Legislative Issues): H.R. 4: Medicare Prescription Drug Price Negotiation Act (Dingell); H.R. 976: Childrens Health Insurance Program Reauthorization Act (Rangel); H.R. 1535: Children's Health First Act (Dingell); H.R. 1663: Medicare Mental Health Modernization Act (Stark) (continued) H.R. 1990: Medicare Cost Contract Extension and Refinement Act (Pomeroy); H.R. 2147: Healthy Kids Act (Emanuel); H.R. 2945: Medicare Advantage Truth in Advertising Act (Stark); H.R. 2642: Supplemental Appropriations Act (provisions relating to moratoria on Medicaid regulations); H.R. 2842: Childrens Health Protection Act (Schwartz); H.R. 3025: Medicare Prescription Drug Savings for Our Seniors Act (Doggett); H.R. 3061: Medicare Part D Drug Class Protection Act (Doggett); H.R. 3162: Childrens Health and Medicare Protection Act (Dingell); H.R. 3195: ADA Amendments Act (Hoyer); H.R. 3932: Medicare Prescription Drug Savings and Choice Act (Berry); H.R. 3963: Childrens Health Insurance Program Reauthorization Act (Dingell); H.R. 4296: Medicare Electronic Medication and Safety Protection Act (Schwartz); H.R. 5268: Medicaid FMAP (Pallone); H.R. 5480: Medicare Funding Warning Response Act (Hoyer-Boehner); H.R. 5550: Coverage for Young Adult Dependents of Federal Employees (Davis); H.R. 5613: Protecting the Medicaid Safety Net Act (Dingell); H.R. 5683: GAO Act (provisions relating to access to Medicare part C/part D data) (Davis); H.R. 5781: Federal Employees Paid Parental Leave Act (Maloney); H.R. 5840: Insurance Information Act (Kanjorski); H.R. 5918: Small Business Health Options Program Act (Barrow); H.R. 5923: Patients Health Care Reform Act (Shadegg); H.R. 5955: Making Health Care More Affordable Act (Walberg); H.R. 5998: Protecting Children's Health Coverage Act (Pallone); H.R. 6071: Health Care Consumer Protection Act (provisions relating to reinstatement of health insurance following nonpayment of premiums) (Forbes); H.R. 6081: Heroes Earning Assistance and Relief Tax Act (mental health parity and FSA provisions); H.R. 6142: Lawsuits Against Employer-Sponsored Disability Benefit Plans (Andrews); H.R. 6210: Small Business Health Options Program Act (Kind-English); H.R. 6331: Medicare Improvements for Patients and Providers Act (provisions relating to Medicare Advantage, Medicare Part D, Medigap, Medicaid, health care disparities, and electronic prescribing) (Rangel-Dingell); H.R. 6388: GAO Improvement Act (provisions relating to access to Medicare part C/part D data) (Waxman); H.R. 6359: Medicare Beneficiary Protection Act (Biggert); H.R. 6365: Medicare Special Needs Plans Extension and Amendments Act (Kind); S. 3: Medicare Prescription Drug Price Negotiation Act (Reid); S. 130: Medicare Cost Contract Extension and Refinement Act (Allard); S. 401: Keep Children Covered Act (Rockefeller); S. 706: Medicare Advantage Stabilization Fund (Feingold); S. 799: Community Choice Act (Harkin); S. 895: Children's Health First Act (Clinton); S. 1102: Part D Equity for Low-Income Seniors Act (Bingaman); S. 1103: Helping Fill the Medicare Rx Gap Act (Bingaman); S. 1107: Home and Community Services Copayment Equity Act (Smith); S. 1108: Medicare Part D Outreach and Enrollment Enhancement Act (Smith); S. 1200: Indian Health Care Improvement Act (includes Medicaid/MA provisions); S. 1224: Children's Health Insurance Program Reauthorization Act (Rockefeller); S. 1507: Access to Medicare Data Act (Grassley); S. 1544: Medicare Quality Enhancement Act (Gregg); S. 1827: Pharmacist Access and Recognition in Medicare Act (Cochran); S. 1893: Childrens Health Insurance Program Reauthorization Act (Baucus); S. 1954: Pharmacy Access Improvement Act (Baucus); S. 2219: Medicare Prescription Drug Savings and Choice Act (Durbin); S. 2408: Medicare Electronic Medication and Safety Protection Act (Kerry); S. 2620: Medicaid FMAP (Rockefeller); S. 2662: Medicare Funding Warning Response Act (Baucus-Gregg); S. 2795: Small Business Health Options Program Act (Durbin-Snowe); S. 2819: Economic Recovery in Health Care Act (provisions relating to Medicaid funding) (Rockefeller); S. 2948: Small Business Empowerment Act (Brown); S. 2818: Small Business Health Plans Act (Enzi); S. 2999: Access to Cancer Clinical Trials Act (Brown); S. 3068: Equity in Prescription Insurance and Contraceptive Coverage Act (Snowe); S. 3101: Medicare Improvements for Patients and Providers Act (provisions relating to Medicare Advantage, Medicare Part D, Medigap, Medicaid, health care disparities, electronic prescribing) (Baucus); S. 3115: Childrens Health Protection Act (Lautenberg); S. 3118: Preserving Access to Medicare Act (provisions relating to Medicare Advantage, Medicare Part D, Medicaid, and electronic prescribing)(Grassley). MMM (Regulatory Issues) Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology and data issues, (including encounter data issues) bidding and payment issues (including MA coding intensity, Part D reinsurance, low income subsidies, application process, and audits), application process, and audits, benefit design rules, SSA and CMS premium withhold processing issues, systems issues affecting enrollment and disenrollment processing, enrollment rules, marketing materials review and approval, marketing activities, including conduct of brokers and agents and plan sponsor marketing staff and issues raised by CMS about Private Fee-for-Service (PFFS) plan marketing, measurement and oversight of plan performance including Special Needs Plans (SNPs); grievance and appeals processes, compliance/fraud and abuse training, and Medicare/Medicaid integration issues for Special Needs Plans (SNPs); Federal premption of State authorization over MA and Part D plans, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, and other operational issues; Medicare creditable drug coverage reporting requirements; implementation issues for the Medicare Retiree Drug Subsidy program; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education program; ongoing implementation issues for the Medicare cost plan program including enrollment, marketing materials review and approval, systems issues affecting enrollment and disenrollment processing, payment and other operational issues; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting inititiative; issues relating to Medicare coverage policy and national coverage decisions; Medicare clinical trials; Medicaid managed care regulations and policies, including the Medicaid managed care actuarial soundness standard, quality oversight, grievance and appeals processes, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including intergovernmental transfers (IGTs) and federal matching funds for graduate medical education; coordination of benefits with state Medicaid programs; Medicaid prescription drug cost/rebate issues affecting Medicaid health plans; health plan-related State Childrens Health Insurance Program (SCHIP) issues, including eligibility and outreach issues; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including documentation of citizenship requirements, state benefit flexibility options, and Medicaid managed care organization provider tax issues; standards for electronic prescribing; and health information technology standards and policies.

Health Information Technology, Electronic Prescribing, Genetic Nondiscrimination, Inappropriate use of Human Growth Hormone, Medicare Part D Contract Disclsoure Requirements, Comparative Effectiveness, 340B Program, Confidentiality of Health Information, Generic Drugs, Generic Biologics, Internet Pharmacies, Off-Label Use of Prescription Drugs, Over-the-Counter Drug Dispersement, Carve-out of Generic Drugs from State Medicaid Generic Substitution Laws HR 493 and S 358 - Genetic Information Nondiscrimination Act of 2008; Title I HR 971 and S 885 - Community Pharmacy Fairness Act of 2007; all aspects HR 1432 and S. 316 - Preserve Access to Affordable Generics Act; all aspects HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; all aspects HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007; all aspects HR 2567 and S 870 - Medicare Home Infusion Therapy Coverage Act of 2007; all aspects HR 2606 and S 1376 - 340B Program Improvement and Integrity Act of 2007; all aspects HR 2914 - Medicare IVIG Access Act of 2007; all aspects HR 2970 - Pharmacy Benefit Manager Transparency Act of 2007; all aspects HR 3140 - Saving Our Community Pharmacies Act of 2007; all aspects HR 3090 - Patient and Pharmacy Protection Act of 2007; all aspects HR 3193 - Access to Community Pharmacy Preservation Act of 2007; all aspects HR 3800 - Promoting Health Information Technology Act; all aspects HR 3932 - Medicare Prescription Drug Savings and Choice Act of 2007; all aspects HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; all aspects HR 5629 - Pathway for Biosimilars Act; all aspects HR 5683 - Government Accountability Office Act of 2008, section 721 HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008; all aspects S 28 - Generics First Act of 2007; all aspects S 242 - Pharmaceutical Market Access and Drug Safety Act of 2007; all aspects S 251 - Pharmaceutical Market Access Act of 2007; all aspects S 273 - Prescription Drug and Health Improvement Act of 2007; all aspects S 596 - Safe Internet Pharmacy Act of 2007; section 511(c) S 976 - Genomics and Personalized Medicine Act of 2007; all aspects S 980 - Ryan Haight Online Pharmacy Consumer Protection Act of 2007; all aspects S 1408 - Health Information Technology Act of 2007; all aspects S 1507 - Access to Medicare Data Act of 2007; all aspects S 1693 - Wired for Health Care Quality Act; all aspects S 1695 - Biologics Price Competition and Innovation Act of 2007; all aspects S. 1814 - Health Information Privacy and Security Act; all aspects S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007; all aspects S 2161 - Community Pharmacy Fairness Act of 2007; all aspects

HR 493 and S 358 - Genetic Information Nondiscrimination Act of 2007; Title I HR 971 and S 885 - Community Pharmacy Fairness Act of 2007; all aspects HR 1432 and S. 316 - Preserve Access to Affordable Generics Act; all aspects HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; all aspects HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007; all aspects HR 2567 and S 870 - Medicare Home Infusion Therapy Consolidated Coverage Act of 2007; all aspects HR 2606 and S 1376 - 340B Program Improvement and Integrity Act of 2007; all aspects HR 2914 - Medicare IVIG Access Act of 2007; all aspects HR 2970 - Pharmacy Benefit Manager Transparency Act of 2007; all aspects HR 3140 - Saving Our Community Pharmacies Act of 2007; all aspects HR 3090 - Patient and Pharmacy Protection Act of 2007; all aspects HR 3193 - Access to Community Pharmacy Preservation Act of 2007; all aspects HR 3800 - Promoting Health Information Technology Act; all aspects HR 3932 - Medicare Prescription Drug Savings and Choice Act of 2007; all aspects HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; all aspects HR 5629 - Pathway for Biosimilars Act; all aspects HR 5683 - Government Accountability Office Act of 2008, section 721 HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008; all aspects S 28 - Generics First Act of 2007; all aspects S 242 - Pharmaceutical Market Access and Drug Safety Act of 2007; all aspects S 251 - Pharmaceutical Market Access Act of 2007; all aspects S 273 - Prescription Drug and Health Improvement Act of 2007; all aspects S 596 - Safe Internet Pharmacy Act of 2007; section 511(c); all aspects S 976 - Genomics and Personalized Medicine Act of 2007; all aspects S 980 - Online Pharmacy Consumer Protection Act of 2007; all aspects S 1408 - Health Information Technology Act of 2007; all aspects S 1507 - Access to Medicare Data Act of 2007; all aspects S 1693 - Wired for Health Care Quality Act; all aspects S 1695 - Biologics Price Competition and Innovation Act of 2007; all aspects S. 1814 - Health Information Privacy and Security Act; all aspects S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007; all aspects S 2161 - Community Pharmacy Fairness Act of 2007; all aspects