Pharmaceutical Stewardship Act of 2011

HR 2546, the Medical Waste Management Act HR 2939, the Pharmaceutical Stewardship Act of 2011 Issues pertaining to medical and pharmaceutical (including controlled substances) waste management

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Departments of Labor, Health and Human Services, and Education Appropriations Act, 2013 (S.3295) House FY 13 Budget (H.Con.Res. 112) The Ryan Creedon Act of 2011 (H.R. 2119) Cap, Cut and Balance Bill (HR 2560/S. 1340) Commerce/Justice/Science FY13 Appropriations (H.R. 5326/S. 2323) Consolidated FY2012 Appropriations Act (was Military/Veterans; HR 2055) Reauthorization of Drug-Free Communities Support Program (S. 2159) Food and Drug Administration Reform Act of 2012 (H.R. 5651/S. 3187) Access to Substance Abuse Treatment Act of 2012 (H.R. 5711) Excellence in Mental Health (S. 2257/H.R. 5989) Behavioral Health Information Technology Act of 2011 (S. 539/H.R. 6043) Health Equity and Accountability Act (HEAA) of 2012 (S. 2474/H.R.2954) Pharmaceutical Stewardship Act of 2011 (H.R. 2939) Mental Health ACCESS Act of 2012 (S. 3340) Medicaid Information Technology to Enhance Community Health Act of 2012 (S.3539) Recidivism Reduction Act (H.R.6256)

Client expense: $8,670 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

House FY 13 Budget (H.Con.Res. 112) Mental Health in Schools Act (H.R. 751) Labor, Health and Human Services, and Education, and Related Agencies FY 12 Appropriations Act (S.1599/H.R.3070) Behavioral Health Information Technology Act of 2011 (S. 539/H.R. 6043) Healthy Lifestyles and Prevention America Act (S.174) Medicare Mental Health Access Act (S.483) Seniors Mental Health Access Improvement Act of 2011 (S.604) Medicare Mental Health Inpatient Equity Act (S.374) A Bill To repeal mandatory funding provided to States in the Patient Protection and Affordable Care Act to establish American Health Benefit Exchanges (HR 1213) A Bill To repeal mandatory funding for school-based health center construction (HR 1214) A Bill To repeal the Prevention and Public Health Fund (HR 1217) Patients Rights Repeal Act (H.R. 2) Medicaid Maintenance-Of-Effort Repeal (H.R.1683/S. 868) The Garrett Lee Smith Memorial Act (GLSMA) Reauthorization of 2011 (S. 740) The Sergeant Coleman S. Bean Reserve Component Suicide Prevention Act (H.R. 1089/S. 579) The Keeping All Students Safe Act (H.R. 1381/S.2020) The Ryan Creedon Act of 2011 (H.R. 2119) Mental Health on Campus Improvement Act, H.R. 1833 Constitutional Balanced Budget Amendment (H.J.Res. 1/S.J.Res. 23) Agriculture FY12 Appropriations (HR 2112) Military/Veterans FY12 Appropriations (HR 2055) Medicare Decisions Accountability Act of 2011 (IPAB; HR 452/S. 668) Cap, Cut and Balance Bill (HR 2560/S. 1340) CAMPUS Safety Act of 2011 (HR 2342) Health Equity and Accountability Act of 2011 (H.R.2954) Continuing Appropriations Act, 2012 (HR 2608) Medigap Medical Loss Ratio Improvement Act (S.1416/H.R.2645) Improving Access to Medicare Coverage Act of 2011 (S.818) Stop Child Abuse in Residential Programs for Teens Act of 2011 (H.R.3126) Commerce/Justice/State FY12 Appropriations Act (HR.2596/S.1572) Promoting Accountability and Excellence in Child Welfare Act (S. 1509) Lifespan Respite Reauthorization Act (HR 3266) Consolidated FY2012 Appropriations Act (was Military/Veterans; HR 2055) Children's Budget Act (S.1396) Middle Class Tax Cut Act of 2011 (H.R. 3630) Speak Up Act Letter of Support (S. 1877) Reauthorization of Drug-Free Communities Support Program (S. 2159) WIPA and PABSS Continuation of Services Act of 2012 (H.R.6061) The Childrens Mental Health Accessibility Act (S. 3289) Departments of Labor, Health and Human Services, and Education Appropriations Act, 2013 (S.3295) Military/Veterans FY13 Appropriations (H.R. 5854/S. 3215) Excellence in Mental Health (S. 2257/H.R. 5989) Mental Health First Aid Higher Education Act (S. 3325/H.R. 5996) Health Equity and Accountability Act (HEAA) of 2012 (S. 2474) Pharmaceutical Stewardship Act of 2011 (H.R. 2939) Food and Drug Administration Reform Act of 2012 (H.R. 5651/S. 3187) Mental Health ACCESS Act of 2012 (S. 3340) Medicaid Information Technology to Enhance Community Health Act of 2012 (S.3539) Recidivism Reduction Act (H.R.6256) To provide payment for patient navigator services under title XIX of the Social Security Act (H.R.6521)

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues generating antibiotic incentives. - HR 1282, "Generating Antibiotics Incentives Now Act of 2011", regarding all provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Access to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - HR 5937, "Breast Cancer Patient Education Act of 2012", regarding all provisions. - HR 5998, "USPSTF Transparency and Accountability Act of 2012", regarding all provisions. - S 3187, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - S 2516, "Food and Drug Administration Safety and Innovation Act", regarding all provisions.

H.R. 872, Reducing Regulatory Burdens Act of 2011 S. 718, to amend the Federal Insecticide, Fungicide, and Rodenticide Act H.R. 2030 and S. 1115, Green Infrastructure for Clean Water Act of 2011 Unnumbered House and S. 898, Safe Treatment of Polluted Stormwater Runoff Act of 2011 Unnumbered House and Senate bills, Water Resources Development Act, (National Sustainable Rivers Program) (Levee Safety Program) H.R. 1967 and unnumbered Senate bill, Water Advanced Technologies for Efficient Resource Use Act of 2011 (WaterSense Authorization) H.R. 2018 and S. 3558, Clean Water Cooperative Federalism Act of 2011 S. 1502, Clean Rivers Act of 2011 H.R. 4166, Coal Tar Sealants Reduction Act of 2012 H.R. 3010 and S. 1606, Regulatory Accountability Act of 2011 (Manager's amendment) S. 299, the Regulations from the Executive in Need of Scrutiny Act S. 1938, the Regulatory Flexibility Improvements Act H.R. 2273 and S. 1751, Coal Residuals Reuse and Management Act of 2011 H.R. 2939, Pharmaceutical Stewardship Act of 2011 H.R. 3145, Water Quality Protection and Job Creation Act of 2011 H.R. 10, Regulations from the Executive in Need of Scrutiny (REINS) H.R. 527, Regulatory Flexibility Improvements Act H.R. 2840, Commercial Vessel Discharges Reform Act of 2011 S. 1669 and H.R. 2738, Water Infrastructure Resiliency and Sustainability Act of 2011 S. 2104, Water Resources Research Amendments Act of 2012 S. 2094, Clean Water Affordability Act of 2012 H.R. 4337, Chesapeake Bay State and Local Backstop Limitation Act of 2012 H.R. 4153, Chesapeake Bay Program Reauthorization and Improvement Act of 2012 S. 2122 and H.R. 4304, Defense of Environment and Property Act of 2012 H.R. 4345, Domestic Fuels Protection Act of 2012 S. 2245, Preserve the Waters of the United States Act H.R. 4965, To preserve existing rights and responsibilities with respect to waters of the United States, and for other purposes H.R. 4278, Preserving Rural Resources Act of 2012 H.R. 5961, Farmer's Privacy Act of 2012 H.R. 2541, Silviculture Regulatory Consistency Act H.R. 3158, Farmers Undertake Environmental Land Stewardship Act H.R. 4078, Red Tape Reduction and Small Business Job Creation Act H.R. 6405 and S. 3549, The Waterfront Brownfields Revitalization Act H.R. 3409 Stop the War on Coal Act of 2012

S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.

HR 2546, the Medical Waste Management Act HR 2939, the Pharmaceutical Stewardship Act of 2011 Issues pertaining to medical and pharmaceutical (including controlled substances) waste management

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

House FY 13 Budget (H.Con.Res. 112) Mental Health in Schools Act (H.R. 751) Labor, Health and Human Services, and Education, and Related Agencies FY 12 Appropriations Act (S.1599/H.R.3070) Behavioral Health Information Technology Act of 2011 (S. 539/H.R. 6043) Healthy Lifestyles and Prevention America Act (S.174) Medicare Mental Health Access Act (S.483) Seniors Mental Health Access Improvement Act of 2011 (S.604) Medicare Mental Health Inpatient Equity Act (S.374) A Bill To repeal mandatory funding provided to States in the Patient Protection and Affordable Care Act to establish American Health Benefit Exchanges (HR 1213) A Bill To repeal mandatory funding for school-based health center construction (HR 1214) A Bill To repeal the Prevention and Public Health Fund (HR 1217) Patients Rights Repeal Act (H.R. 2) Medicaid Maintenance-Of-Effort Repeal (H.R.1683/S. 868) The Garrett Lee Smith Memorial Act (GLSMA) Reauthorization of 2011 (S. 740) The Sergeant Coleman S. Bean Reserve Component Suicide Prevention Act (H.R. 1089/S. 579) The Keeping All Students Safe Act (H.R. 1381/S.2020) The Ryan Creedon Act of 2011 (H.R. 2119) Mental Health on Campus Improvement Act, H.R. 1833 Constitutional Balanced Budget Amendment (H.J.Res. 1/S.J.Res. 23) Agriculture FY12 Appropriations (HR 2112) Military/Veterans FY12 Appropriations (HR 2055) Medicare Decisions Accountability Act of 2011 (IPAB; HR 452/S. 668) Cap, Cut and Balance Bill (HR 2560/S. 1340) CAMPUS Safety Act of 2011 (HR 2342) Health Equity and Accountability Act of 2011 (H.R.2954) Continuing Appropriations Act, 2012 (HR 2608) Medigap Medical Loss Ratio Improvement Act (S.1416/H.R.2645) Improving Access to Medicare Coverage Act of 2011 (S.818) Stop Child Abuse in Residential Programs for Teens Act of 2011 (H.R.3126) Commerce/Justice/State FY12 Appropriations Act (HR.2596/S.1572) Promoting Accountability and Excellence in Child Welfare Act (S. 1509) Lifespan Respite Reauthorization Act (HR 3266) Consolidated FY2012 Appropriations Act (was Military/Veterans; HR 2055) Children's Budget Act (S.1396) Middle Class Tax Cut Act of 2011 (H.R. 3630) Speak Up Act Letter of Support (S. 1877) Reauthorization of Drug-Free Communities Support Program (S. 2159) WIPA and PABSS Continuation of Services Act of 2012 (H.R.6061) The Childrens Mental Health Accessibility Act (S. 3289) Departments of Labor, Health and Human Services, and Education Appropriations Act, 2013 (S.3295) Military/Veterans FY13 Appropriations (H.R. 5854/S. 3215) Excellence in Mental Health (S. 2257/H.R. 5989) Mental Health First Aid Higher Education Act (S. 3325/H.R. 5996) Health Equity and Accountability Act (HEAA) of 2012 (S. 2474) Pharmaceutical Stewardship Act of 2011 (H.R. 2939) Food and Drug Administration Reform Act of 2012 (H.R. 5651/S. 3187) Mental Health ACCESS Act of 2012 (S. 3340)

Departments of Labor, Health and Human Services, and Education Appropriations Act, 2013 (S.3295) House FY 13 Budget (H.Con.Res. 112) The Ryan Creedon Act of 2011 (H.R. 2119) Cap, Cut and Balance Bill (HR 2560/S. 1340) Commerce/Justice/Science FY13 Appropriations (H.R. 5326/S. 2323) Consolidated FY2012 Appropriations Act (was Military/Veterans; HR 2055) Reauthorization of Drug-Free Communities Support Program (S. 2159) Food and Drug Administration Reform Act of 2012 (H.R. 5651/S. 3187) Access to Substance Abuse Treatment Act of 2012 (H.R. 5711) Excellence in Mental Health (S. 2257/H.R. 5989) Behavioral Health Information Technology Act of 2011 (S. 539/H.R. 6043) Health Equity and Accountability Act (HEAA) of 2012 (S. 2474/H.R.2954) Pharmaceutical Stewardship Act of 2011 (H.R. 2939) Mental Health ACCESS Act of 2012 (S. 3340)

Client expense: $10,078 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 2546, the Medical Waste Management Act HR 2939, the Pharmaceutical Stewardship Act of 2011 Issues pertaining to medical and pharmaceutical (including controlled substances) waste management

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2182, Generating Antibiotic Incentives Now Act of 2011, all provisions S. 1734, Generating Antibiotic Incentives Now Act of 2011, all provisions H.R. 4095, Online Pharmacy Safety Act, all provisions S. 2002, Online Pharmacy Safety Act, all provisions H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011, all provisions S. 296, Preserving Access to Life-Saving Medications Act, all provisions H.R. 2086, Medical Debt Responsibility Act of 2011, all provisions S. 2149, Medical Debt Responsibility Act of 2012, all provisions H.R. 5651, Food and Drug Administration Reform Act of 2012, all provisions S. 3187, Food and Drug Administration Safety and Innovation Act, all provisions H.R. 2960, National Diabetes Clinical Care Commission Act, all provisions S. 2295, Patient Safety and Generic Labeling Improvement Act , all provisions H.R. 2119, Ryan Creedon Act of 2011, all provisions H.R. 3497, MODDERN Cures Act of 2011, all provisions H.R. 3207, Modernizing Laboratory Test Standards for Patients Act of 2011, all provisions H.R. 2939, Pharmaceutical Stewardship Act of 2011, all provisions H.R. 866, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2011, all provisions H.R. 3839, Drug Shortage Prevention Act of 2012, all provisions H.R. 5842, Restoring Access to Medication Act of 2012, all provisions S.Amdt. 2151, To amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug Mandatory CME for DEA Registrants Bath Salts Tanning Beds Affordable Care Act Insurance exchanges Violence Against Women Act, provisions relating to quality Drug Shortages Prescription Drug Abuse Next generation antibiotics Scope of Practice Health Insurance Reform Health Information Technology Flexible Spending Accounts/OTC medications Tax deduction for physician charity care HIPAA Administrative Simplification HIPAA privacy and security standards Regulation of energy beverages Unique Device Identification System Multi-Payor Claims Database Private payer guidelines for reporting data to physicians

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues generating antibiotic incentives. - HR 1282, "Generating Antibiotics Incentives Now Act of 2011", regarding all provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3209, "Premarket Predictability Act of 2011", regarding all provisions. - HR 3203/ S 1943, "Novel Device Regulatory Relief Act of 2011", regarding all provisions. - HR 3230, "Keeping America Competitive Through Harmonization Act of 2011", regarding all provisions. - HR 3211, "Humanitarian Device Reform Act of 2011", regarding all provisions. - HR 3208, "Patients Come First Act of 2011", regarding all provisions. - HR 3206, "Cultivating Scientific Expertise to Foster Inovation for Patients Act of 2011", regarding all provisions. - HR 3214/ S 1972, "Food and Drug Administration Mission Reform Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - HR 3204, "Guidance Accountability and Transparency Act of 2011", regarding all provisions. - HR 3205, "FDA Renewing Efficiency From Outside Reviewer Management Act of 2011", regarding all provisons. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Acess to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards.

H.R. 872, Reducing Regulatory Burdens Act of 2011 S. 718, to amend the Federal Insecticide, Fungicide, and Rodenticide Act H.R. 2030 and S. 1115, Green Infrastructure for Clean Water Act of 2011 Unnumbered House and S. 898, Safe Treatment of Polluted Stormwater Runoff Act of 2011 Unnumbered House and Senate bills, Water Resources Development Act, (National Sustainable Rivers Program) (Levee Safety Program) H.R. 1967 and unnumbered Senate bill, Water Advanced Technologies for Efficient Resource Use Act of 2011 (WaterSense Authorization) H.R. 2018, Clean Water Cooperative Federalism Act of 2011 S. 1502, Clean Rivers Act of 2011 H.R. 4166, Coal Tar Sealants Reduction Act of 2012 H.R. 3010 and S. 1606, Regulatory Accountability Act of 2011 (Manager's amendment) S. 299, the Regulations from the Executive in Need of Scrutiny Act S. 1938, the Regulatory Flexibility Improvements Act H.R. 2273 and S. 1751, Coal Residuals Reuse and Management Act of 2011 H.R. 2939, Pharmaceutical Stewardship Act of 2011 H.R. 3145, Water Quality Protection and Job Creation Act of 2011 H.R. 10, Regulations from the Executive in Need of Scrutiny (REINS) H.R. 527, Regulatory Flexibility Improvements Act H.R. 2840, Commercial Vessel Discharges Reform Act of 2011 S. 1669 and H.R. 2738, Water Infrastructure Resiliency and Sustainability Act of 2011 S. 2104, Water Resources Research Amendments Act of 2012 S. 2094, Clean Water Affordability Act of 2012 H.R. 4337, Chesapeake Bay State and Local Backstop Limitation Act of 2012 H.R. 4153, Chesapeake Bay Program Reauthorization and Improvement Act of 2012 S. 2122 and H.R. 4304, Defense of Environment and Property Act of 2012 H.R. 4345, Domestic Fuels Protection Act of 2012 S. 2245, Preserve the Waters of the United States Act H.R. 4965, To preserve existing rights and responsibilities with respect to waters of the United States, and for other purposes

S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.

S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.

HR 2546, the Medical Waste Management Act HR 2939, the Pharmaceutical Stewardship Act of 2011 Issues pertaining to medical and pharmaceutical (including controlled substances) waste management

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 872, Reducing Regulatory Burdens Act of 2011 S. 718, to amend the Federal Insecticide, Fungicide, and Rodenticide Act H.R. 2030 and S. 1115, Green Infrastructure for Clean Water Act of 2011 S. 898 and Unnumbered House bill, Safe Treatment of Polluted Stormwater Runoff Act of 2011 Unnumbered House and Senate bills, Water Resources Development Act, (National Sustainable Rivers Program) (Levee Safety Program) H.R. 1967 and unnumbered Senate bill, Water Advanced Technologies for Efficient Resource Use Act of 2011 (WaterSense Authorization) H.R. 2018, Clean Water Cooperative Federalism Act of 2011 S. 1502, Clean Rivers Act of 2011 H.R. 4166, Coal Tar Sealants Reduction Act of 2012 H.R. 3010 and S. 1606, Regulatory Accountability Act of 2011 (Manager's amendment) S. 299, the Regulations from the Executive in Need of Scrutiny Act S. 1938, the Regulatory Flexibility Improvements Act H.R. 2273 and S. 1751, Coal Residuals Reuse and Management Act of 2011 H.R. 2939, Pharmaceutical Stewardship Act of 2011 H.R. 3145, Water Quality Protection and Job Creation Act of 2011 H.R. 10, Regulations from the Executive in Need of Scrutiny (REINS) H.R. 527, Regulatory Flexibility Improvements Act H.R. 2840, Commercial Vessel Discharges Reform Act of 2011 S. 1669 and H.R. 2738, Water Infrastructure Resiliency and Sustainability Act of 2011 S. 2104, Water Resources Research Amendments Act of 2012 H.R. 4337, Chesapeake Bay State and Local Backstop Limitation Act of 2012 H.R. 4153, Chesapeake Bay Program Reauthorization and Improvement Act of 2012 S. 2122 and H.R. 4304, Defense of Environment and Property Act of 2012 H.R. 4345, Domestic Fuels Protection Act of 2012

Client expense: $29,217 · Firm income: Not reported

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues generating antibiotic incentives. - HR 1282, "Generating Antibiotics Incentives Now Act of 2011", regarding all provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3209, "Premarket Predictability Act of 2011", regarding all provisions. - HR 3203/ S 1943, "Novel Device Regulatory Relief Act of 2011", regarding all provisions. - HR 3230, "Keeping America Competitive Through Harmonization Act of 2011", regarding all provisions. - HR 3211, "Humanitarian Device Reform Act of 2011", regarding all provisions. - HR 3208, "Patients Come First Act of 2011", regarding all provisions. - HR 3206, "Cultivating Scientific Expertise to Foster Inovation for Patients Act of 2011", regarding all provisions. - HR 3214/ S 1972, "Food and Drug Administration Mission Reform Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - HR 3204, "Guidance Accountability and Transparency Act of 2011", regarding all provisions. - HR 3205, "FDA Renewing Efficiency From Outside Reviewer Management Act of 2011", regarding all provisons. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Acess to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards.

H.R. 2119, Ryan Creedon Act of 2011, all provisions H.R. 3497, MODDERN Cures Act of 2011, all provisions H.R. 3207, Modernizing Laboratory Test Standards for Patients Act of 2011, all provisions H.R. 866, National All Schedules Prescription Electronic Reporting (NASPER) Reauthorization Act of 2011, all provisions H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act of 2011, all provisions S. 1734, Generating Antibiotic Incentives Now (GAIN) Act of 2011, all provisions H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011, all provisions S. 296, Preserving Access to Life-Saving Medications Act, all provisions H.R. 2086, Medical Debt Responsibility Act of 2011, all provisions S. 2149, Medical Debt Responsibility Act of 2012, all provisions H.R. 4095, Online Pharmacy Safety Act, all provisions S. 2002, Online Pharmacy Safety Act, all provisions H.R. 2529, Restoring Access to Medication Act, all provisions S. 1368, Restoring Access to Medication Act, all provisions H.R. 2939, Pharmaceutical Stewardship Act of 2011, all provisions S. 2096, Federal Research Public Access Act of 2012, all provisions Patient Safety and Generic Label Improvement Act draft bill, all provisions Affordable Care Act Transparency Reporting/Sunshine Act Regulations Prescription Drug User Fee Act (PDUFA) Medical Licensing Boards and Scope of Practice Drug Shortages Combating prescription drug diversion Flexible Spending Accounts Antibiotics and drug resistant pathogens Comparative Effectiveness Research Physician Education - HIPAA privacy protections Over-the-Counter Medicine WHO data collection International health and chronic disease Shared Savings/Accountable Care Organizations Health Insurance Reform Healthcare Delivery and Payment Reform All payer all claims databases Definition of a Fact Box ICD-10 Stand for Quality Coalition Health Information Technology Scope of Practice

S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.

HR 2546, the Medical Waste Management Act HR 2939, the Pharmaceutical Stewardship Act of 2011 Monitoring issues pertaining to medical and pharmaceutical waste management.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 979, the FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act of 2011, legislation to reform oversight authority for OPM for the FEHBP drug benefit; H.R. 891 and S. 274, the Medication Therapy Management Benefits Act of 2011, which would expand beneficiary access to MTM services under Part D; H.R. 1041, the Fairness in Medicare Bidding Act, this legislation would repeal the competitive bidding program, in the Medicare Part B durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) program; S. 1058 and H.R. 1971, the Pharmacy Competition and Consumer Choice Act of 2011, this legislation expands transparency requirements for PBMs and limits certain audit practices by PBMs; H.R. 1936, the Medicare Access to Diabetes Act of 2011, legislation exempts small pharmacies from the DME competitive bidding program for diabetes test supplies; H.R. 1946, the Preserving Our Hometown Independent Pharmacies Act of 2011, would provide a narrow anti-trust exemption to allow small pharmacies to form pools to negotiate with PBMs; HR. 1409, the Quality Health Care Coalition Act of 2011, legislation would exempt health care professionals from federal antitrust laws for the purposes of contract negotiations with health plans; H.R. 1839, the Community Pharmacy Fairness Act, legislation would provide a narrow anti-trust exemption, which would allow groups of independent pharmacies to negotiate PBM contracts; S. 1560, Nursing Home Resident Pain Relief Act of 2011; S. 1699, a bill to reduce the costs of prescription drugs under the Medicare program, and for other purposes; Worked with Senate Finance and House Energy and Commerce staff on addressing questions raised by GAO regarding a study being conducted on the 3408 drug program as well as educating staff on the current 340b program; Sought Congressional support for the FTC investigation of the merger between two major national PBMs; H.R. 1540 and S. 1253, the National Defense Authorization Act for FY 12, includes funding for the TRICARE pharmacy program; H.R. 1316, the Pill Mill Crackdown Act of 2011; S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011; S. 513, Saving Kids from Dangerous Drugs Act of 2011; H.R. 2939 Pharmaceutical Stewardship Act of 2011; H.R. 866, the National All Schedules Prescription Electronic Reporting Act (NASPER) Reauthorization Act of 2011, that would again reauthorize NASPER for 3 additional years; S. 1356 Affordable Medicines Utilization Act of 2011; S. 296 Preserving Access to Life-Savings Medications Act of 200; S 1699, Prescription Drug Cost Reduction Act; S. 1867, National Defense Authorization Act for 2012; S. 2002, Online Pharmacy Safety Act; S.1251, Medicare and Medicare FAST Act; S. 882 STOP Act; S. 319 Pharmaceutical Market Access and Drug Safety Act of 2011; S. 1002, SAFE Doses Act; The Joint Select Committee on Deficit Reduction

H.R. 979, the FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act of 2011, legislation to reform oversight authority for OPM for the FEHBP drug benefit; H.R. 891 and S. 274, the Medication Therapy Management Benefits Act of 2011, which would expand beneficiary access to MTM services under Part D; H.R. 1041, the Fairness in Medicare Bidding Act, this legislation would repeal the competitive bidding program, in the Medicare Part B durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) program; S. 1058 and H.R. 1971, the Pharmacy Competition and Consumer Choice Act of 2011, this legislation expands transparency requirements for PBMs and limits certain audit practices by PBMs; H.R. 1936, the Medicare Access to Diabetes Act of 2011, legislation exempts small pharmacies from the DME competitive bidding program for diabetes test supplies; H.R. 1946, the Preserving Our Hometown Independent Pharmacies Act of 2011, would provide a narrow anti-trust exemption to allow small pharmacies to form pools to negotiate with PBMs; HR. 1409, the Quality Health Care Coalition Act of 2011, legislation would exempt health care professionals from federal antitrust laws for the purposes of contract negotiations with health plans; H.R. 1839, the Community Pharmacy Fairness Act, legislation would provide a narrow anti-trust exemption, which would allow groups of independent pharmacies to negotiate PBM contracts; S. 1560, Nursing Home Resident Pain Relief Act of 2011; S. 1699, a bill to reduce the costs of prescription drugs under the Medicare program, and for other purposes; Worked with Senate Finance and House Energy and Commerce staff on addressing questions raised by GAO regarding a study being conducted on the 3408 drug program as well as educating staff on the current 340b program; Sought Congressional support for the FTC investigation of the merger between two major national PBMs; H.R. 1540 and S. 1253, the National Defense Authorization Act for FY 12, includes funding for the TRICARE pharmacy program; H.R. 1316, the Pill Mill Crackdown Act of 2011; S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011; S. 513, Saving Kids from Dangerous Drugs Act of 2011; NCPA Submits Statement for Senate Committee Hearing on Drug Supply Safety. The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing this week on Securing the Pharmaceutical Supply Chain.; NCPA sent a letter to the Special Congressional Committee charged with finding $1.2 trillion in Federal program savings, outlining our proposals to reduce costs while preserving patient choice and access to community pharmacy; NCPA Submits Statement on Drug Shortages Hearing. NCPA submitted a statement outlining our concerns as the FDA and private sector continue to work on resolving the drug shortages issue; Pharmaceutical Stewardship Act of 2011 (H.R. 2939), to provide for the disposal of drugs pursuant to national pharmaceutical stewardship programs; H.R. 866, the National All Schedules Prescription Electronic Reporting Act (NASPER) Reauthorization Act of 2011, that would again reauthorize NASPER for 3 additional years. S. 312 and H.R. 605, the Patients' Freedom to Choose Act, which would repeal the provision in the 2010 health care law that prohibits individuals from using funds from either Health Savings Accounts (HSAs) or Flexible Spending Accounts (FSAs) to purchase over-the-counter medication without a prescription.

H.R. 872, Reducing Regulatory Burdens Act of 2011 S. 718, to amend the Federal Insecticide, Fungicide, and Rodenticide Act H.R. 2030 and S. 1115, Green Infrastructure for Clean Water Act of 2011 Unnumbered House and S. 898, Safe Treatment of Polluted Stormwater Runoff Act of 2011 Unnumbered House and Senate bills, Water Resources Development Act, National Sustainable Rivers Program Unnumbered House and Senate bills, WaterSense Authorization H.R. 2018, Clean Water Cooperative Federalism Act of 2011 S. 1502, Clean Rivers Act of 2011 Unnumbered House Bill, Coal Tar Sealants Reduction Act of 2011 H.R. 3010 and S. 1606, Regulatory Accountability Act of 2011 (Manager's amendment) H.R. 2273 and S. 1751, Coal Residuals Reuse and Management Act of 2011 H.R. 2939, Pharmaceutical Stewardship Act of 2011 H.R. 3145, Water Quality Protection and Job Creation Act of 2011 H.R. 10, Regulations from the Executive in Need of Scrutiny (REINS) H.R. 527, Regulatory Flexibility Improvements Act H.R. 2840, Commercial Vessel Discharges Reform Act of 2011 S. 1669 and H.R. 2738, Water Infrastructure Resiliency and Sustainability Act of 2011 H.R. 2842, Bureau of Reclamation Small Conduit Hydropower Development and Rural Jobs Act of 2011

Client expense: $22,964 · Firm income: Not reported

Amendment 814 to H.R. 2112 Commodity Futures Tranding Commission rules H.R. 2939, 2940 Changes to SEC crowdfunding rules H.R. 3156 Consumer Debit Card Protection Act

Client expense: $44,963 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues generating antibiotic incentives. - Issues related to the Better Act - HR 1282, "Generating Antibiotics Incentives Now Act of 2011", regarding all provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Physician Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3209, "Premarket Predictability Act of 2011", regarding all provisions. - HR 3203/ S 1943, "Novel Device Regulatory Relief Act of 2011", regarding all provisions. - HR 3230, "Keeping America Competitive Through Harmonization Act of 2011", regarding all provisions. - HR 3211, "Humanitarian Device Reform Act of 2011", regarding all provisions. - HR 3208, "Patients Come First Act of 2011", regarding all provisions. - HR 3206, "Cultivating Scientific Expertise to Foster Inovation for Patients Act of 2011", regarding all provisions. - HR 3214/ S 1972, "Food and Drug Administration Mission Reform Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - HR 3204, "Guidance Accountability and Transparency Act of 2011", regarding all provisions. - HR 3205, "FDA Renewing Efficiency From Outside Reviewer Management Act of 2011", regarding all provisons. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA.

PL 111-148, PL 111-152Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies S 1002 Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES)drug safety HR 1483 The Drug Safety Enhancement Act of 2011 - drug safety standards HR 1930, S 1799 Access to Appropriate Immunizations for Veterans Act of 2011 - extending VA performance measure to include all federally recommended vaccine HR 3202 Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety ADDENDUM/General Lobbying Issue Area - Prescription Drug User Fee Act (currently unassigned) - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 Drug Safety and Accountability Act of 2011- provisions related to drug safety ADDENDUM/General Lobbying Issue Area - Federal Food, Drug, and Cosmetic Act (currently unassigned) - section related to FDA and regulation of nicotine replacement therapies S. 1699 Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.

H.R. 979, the FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act of 2011, legislation to reform oversight authority for OPM for the FEHBP drug benefit; SEE ADDENDUM H.R. 891 and S. 274, the Medication Therapy Management Benefits Act of 2011; H.R. 1041, the Fairness in Medicare Bidding Act, this legislation would repeal the competitive bidding program, in the Medicare Part B durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) program; S. 1058 and H.R. 1971, the Pharmacy Competition and Consumer Choice Act of 2011; H.R. 1936, the Medicare Access to Diabetes Act of 2011; H.R. 1946, the Preserving Our Hometown Independent Pharmacies Act of 2011; HR. 1409, the Quality Health Care Coalition Act of 2011; H.R. 1839, the Community Pharmacy Fairness Act; S. 1560, Nursing Home Resident Pain Relief Act of 2011; S. 1699, a bill to reduce the costs of prescription drugs under the Medicare program; Sought Congressional support for the FTC investigation of the merger between two major national PBMs; H.R. 1540 and S. 1253, the National Defense Authorization Act for FY 12; H.R. 1316, the Pill Mill Crackdown Act of 2011; S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011; S. 513, Saving Kids from Dangerous Drugs Act of 2011; H.R. 2939, Pharmaceutical Stewardship Act of 2011; H.R. 866, the National All Schedules Prescription Electronic Reporting Act (NASPER) Reauthorization Act of 2011; S. 1356, Affordable Medicines Utilization Act of 2011; S. 296, Preserving Access to Life-Savings Medications Act; H.R. 2245, Preserving Access to Life-Savings; Medications Act of 2011; S. 1699, Prescription Drug Cost Reduction Act; S. 1867, National Defense Authorization Act for 2012; S. 2002, Online Pharmacy Safety Act; S. 1251, Medicare and Medicaid FAST Act; S. 882, STOP Act; S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011; S. 1002, SAFE Doses Act; The Joint Select Committee on Deficit Reduction

H.R. 979, the FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act of 2011, legislation to reform oversight authority for OPM for the FEHBP drug benefit; H.R. 891 and S. 274, the Medication Therapy Management Benefits Act of 2011, which would expand beneficiary access to MTM services under Part D; H.R. 1041, the Fairness in Medicare Bidding Act, this legislation would repeal the competitive bidding program, in the Medicare Part B durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) program; S. 1058 and H.R. 1971, the Pharmacy Competition and Consumer Choice Act of 2011, this legislation expands transparency requirements for PBMs and limits certain audit practices by PBMs; H.R. 1936, the Medicare Access to Diabetes Act of 2011, legislation exempts small pharmacies from the DME competitive bidding program for diabetes test supplies; H.R. 1946, the Preserving Our Hometown Independent Pharmacies Act of 2011, would provide a narrow anti-trust exemption to allow small pharmacies to form pools to negotiate with PBMs; HR. 1409, the Quality Health Care Coalition Act of 2011, legislation would exempt health care professionals from federal antitrust laws for the purposes of contract negotiations with health plans; H.R. 1839, the Community Pharmacy Fairness Act, legislation would provide a narrow anti-trust exemption, which would allow groups of independent pharmacies to negotiate PBM contracts; S. 1560, Nursing Home Resident Pain Relief Act of 2011; S. 1699, a bill to reduce the costs of prescription drugs under the Medicare program, and for other purposes; Worked with Senate Finance and House Energy and Commerce staff on addressing questions raised by GAO regarding a study being conducted on the 3408 drug program as well as educating staff on the current 340b program; Sought Congressional support for the FTC investigation of the merger between two major national PBMs; H.R. 1540 and S. 1253, the National Defense Authorization Act for FY 12, includes funding for the TRICARE pharmacy program; H.R. 1316, the Pill Mill Crackdown Act of 2011; S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011; S. 513, Saving Kids from Dangerous Drugs Act of 2011; NCPA Submits Statement for Senate Committee Hearing on Drug Supply Safety. The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing this week on Securing the Pharmaceutical Supply Chain.; NCPA sent a letter to the Special Congressional Committee charged with finding $1.2 trillion in Federal program savings, outlining our proposals to reduce costs while preserving patient choice and access to community pharmacy; NCPA Submits Statement on Drug Shortages Hearing. NCPA submitted a statement outlining our concerns as the FDA and private sector continue to work on resolving the drug shortages issue; Pharmaceutical Stewardship Act of 2011 (H.R. 2939), to provide for the disposal of drugs pursuant to national pharmaceutical stewardship programs; H.R. 866, the National All Schedules Prescription Electronic Reporting Act (NASPER) Reauthorization Act of 2011, that would again reauthorize NASPER for 3 additional years.

H.R. 872, Reducing Regulatory Burdens Act of 2011 S. 718, To amend the Federal Insecticide, Fungicide, and Rodenticide Act H.R. 2030 and S. 1115, Green Infrastructure for Clean Water Act of 2011 Unnumbered House and S. 898, Safe Treatment of Polluted Stormwater Runoff Act of 2011 S. 629, The Hydropower Improvement Act of 2011 S. 630, The Marine and Hydrokinetic Renewable Energy Promotion Act of 2011 Unnumbered Senate bill addressing Title I, subtitle D of the American Clean Energy Leadership Act of 2009 Unnumbered Senate bill, Clean Energy Standard S. 587, FRAC Act H.R. 1084, Fracturing Responsibility and Awareness of Chemicals Act of 2011 H.R. 910, Energy Tax Prevention Act of 2011 S. 493, the SBIR/STTR Reauthorization Act of 2011, amendment adding S. 482, Energy Tax Prevention Act of 2011 Unnumbered House and Senate bills, Water Resources Development Act, National Sustainable Rivers Program Unnumbered House and Senate bills, WaterSense Authorization H.R. 2018, Clean Water Cooperative Federalism Act of 2011 Unnumbered Senate bill, Wyden natural gas exports bill S. 1502, Clean Rivers Act of 2011 Unnumbered House Bill, Coal Tar Sealants Reduction Act of 2011 H.R. 3010 and S. 1606, Regulatory Accountability Act of 2011 H.R. 2273, Coal Residuals Reuse and Management Act of 2011 H.R. 2939, Pharmaceutical Stewardship Act of 2011 H.R. 3145, Water Quality Protection and Job Creation Act of 2011

Client expense: $30,918 · Firm income: Not reported

H.R. 979, the FEHBP Prescription Drug Integrity, Transparency and Cost Savings Act of 2011, legislation to reform oversight authority for OPM for the FEHBP drug benefit; H.R. 891 and S. 274, the Medication Therapy Management Benefits Act of 2011, which would expand beneficiary access to MTM services under Part D; H.R. 1041, the Fairness in Medicare Bidding Act, this legislation would repeal the competitive bidding program, in the Medicare Part B durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) program; S. 1058 and H.R. 1971, the Pharmacy Competition and Consumer Choice Act of 2011, this legislation expands transparency requirements for PBMs and limits certain audit practices by PBMs; H.R. 1936, the Medicare Access to Diabetes Act of 2011, legislation exempts small pharmacies from the DME competitive bidding program for diabetes test supplies; H.R. 1946, the Preserving Our Hometown Independent Pharmacies Act of 2011, would provide a narrow anti-trust exemption to allow small pharmacies to form pools to negotiate with PBMs; HR. 1409, the Quality Health Care Coalition Act of 2011, legislation would exempt health care professionals from federal antitrust laws for the purposes of contract negotiations with health plans; H.R. 1839, the Community Pharmacy Fairness Act, legislation would provide a narrow anti-trust exemption, which would allow groups of independent pharmacies to negotiate PBM contracts; S. 1560, Nursing Home Resident Pain Relief Act of 2011; S. 1699, a bill to reduce the costs of prescription drugs under the Medicare program, and for other purposes; Worked with Senate Finance and House Energy and Commerce staff on addressing questions raised by GAO regarding a study being conducted on the 3408 drug program as well as educating staff on the current 340b program; Sought Congressional support for the FTC investigation of the merger between two major national PBMs; H.R. 1540 and S. 1253, the National Defense Authorization Act for FY 12, includes funding for the TRICARE pharmacy program; H.R. 1316, the Pill Mill Crackdown Act of 2011; S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011; S. 513, Saving Kids from Dangerous Drugs Act of 2011; NCPA Submits Statement for Senate Committee Hearing on Drug Supply Safety. The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing this week on Securing the Pharmaceutical Supply Chain.; NCPA sent a letter to the Special Congressional Committee charged with finding $1.2 trillion in Federal program savings, outlining our proposals to reduce costs while preserving patient choice and access to community pharmacy; NCPA Submits Statement on Drug Shortages Hearing. NCPA submitted a statement outlining our concerns as the FDA and private sector continue to work on resolving the drug shortages issue; Pharmaceutical Stewardship Act of 2011 (H.R. 2939), to provide for the disposal of drugs pursuant to national pharmaceutical stewardship programs; H.R. 866, the National All Schedules Prescription Electronic Reporting Act (NASPER) Reauthorization Act of 2011, that would again reauthorize NASPER for 3 additional years.

HR 1392/S 1221 - Legislation to ensure payment amounts for drugs and biologicals under Medicare Part B HR 2939 - Legislation to create a Medicare Oncology Pilot Program HR 3200 - House Healthcare Reform Bill - Accountable Care Organizations, Medicare Shared Savings Program Average Sale Price Methodology HR 2366 - Legislation that requires insurance plans to provide equal coverage of oral chemotherapy drugs relative to I.V. chemotherapy. HR 1927 - Legislation to encourage physicians to provide treatment plans to cancer patients. America's Healthy Future Act - Accountable Care Organizations, Medicare Shared Savings Program, Average Sale Price Methodology. 2010 Medicare Physician Fee Schedule Affordable Healthcare for American Act Patient Protection and Affordable Act

Client expense: $180,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

HR 1392/S 1221 - Legislation to ensure payment amounts for drugs and biologicals under Medicare Part B HR 2939 - Legislation to create a Medicare Oncology Pilot Program HR 3200 - House Healthcare Reform Bill - Accountable Care Organizations, Medicare Shared Savings Program Average Sale Price Methodology HR 2366 - Legislation that requires insurance plans to provide equal coverage of oral chemotherapy drugs relative to I.V. chemotherapy. HR 1927 - Legislation to encourage physicians to provide treatment plans to cancer patients. America's Healthy Future Act - Accountable Care Organizations, Medicare Shared Savings Program, Average Sale Price Methodology. 2010 Medicare Physician Fee Schedule Affordable Healthcare for American Act Patient Protection and Affordable Act

Client expense: $180,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

HR 1392/S 1221 - Legislation to ensure payment amounts for drugs and biologicals under Medicare Part B HR 2939 - Legislation to create a Medicare Oncology Pilot Program HR 3200 - House Healthcare Reform Bill - Accountable Care Organizations, Medicare Shared Savings Program Average Sale Price Methodology HR 2366 - Legislation that requires insurance plans to provide equal coverage of oral chemotherapy drugs relative to I.V. chemotherapy. HR 1927 - Legislation to encourage physicians to provide treatment plans to cancer patients. America's Healthy Future Act - Accountable Care Organizations, Medicare Shared Savings Program, Average Sale Price Methodology. 2010 Medicare Physician Fee Schedule Affordable Healthcare for American Act Patient Protection and Affordable Act

Client expense: $80,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

HR 1392/S 1221 - Legislation to ensure payment amounts for drugs and biologicals under Medicare Part B HR 2939 - Legislation to create a Medicare Oncology Pilot Program HR 3200 - House Healthcare Reform Bill - Accountable Care Organizations, Medicare Shared Savings Program Average Sale Price Methodology HR 2366 - Legislation that requires insurance plans to provide equal coverage of oral chemotherapy drugs relative to I.V. chemotherapy. HR 1927 - Legislation to encourage physicians to provide treatment plans to cancer patients. America's Healthy Future Act - Accountable Care Organizations, Medicare Shared Savings Program, Average Sale Price Methodology. 2010 Medicare Physician Fee Schedule Affordable Healthcare for American Act Patient Protection and Affordable Act

Client expense: $80,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

HR 1392/S 1221 - Legislation to ensure payment amounts for drugs and biologicals under Medicare Part B HR 2939 - Legislation to create a Medicare Oncology Pilot Program HR 3200 - House Healthcare Reform Bill - Accountable Care Organizations, Medicare Shared Savings Program Average Sale Price Methodology HR 2366 - Legislation that requires insurance plans to provide equal coverage of oral chemotherapy drugs relative to I.V. chemotherapy. HR 1927 - Legislation to encourage physicians to provide treatment plans to cancer patients. America's Healthy Future Act - Accountable Care Organizations, Medicare Shared Savings Program, Average Sale Price Methodology. 2010 Medicare Physician Fee Schedule Affordable Healthcare for American Act Patient Protection and Affordable Act

Client expense: $80,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

HR 1392/S 1221 - Legislation to ensure payment amounts for drugs and biologicals under Medicare Part B HR 2939 - Legislation to create a Medicare Oncology Pilot Program HR 3200 - House Healthcare Reform Bill - Accountable Care Organizations, Medicare Shared Savings Program Average Sale Price Methodology HR 2366 - Legislation that requires insurance plans to provide equal coverage of oral chemotherapy drugs relative to I.V. chemotherapy. HR 1927 - Legislation to encourage physicians to provide treatment plans to cancer patients. America's Healthy Future Act - Accountable Care Organizations, Medicare Shared Savings Program, Average Sale Price Methodology. 2010 Medicare Physician Fee Schedule Affordable Healthcare for American Act Patient Protection and Affordable Act

Client expense: $80,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE