Antibiotic Development to Advance Patient Treatment Act of 2013

Health Reform Implementation -The Affordable Care Act enacted comprehensive reform of the health care delivery and payments systems in the United States. Specifically, FAH is advocating on implementation issues related to delivery reform affecting hospitals and insurance reform. HITECH Act - Implementation of meaningful use and privacy and security provisions in HITECH Act of 2009. Group Purchasing Organization Regulations - Monitor policy proposals that would result in additional federal regulation of Group Purchasing Organizations. H.R. 1473, the Standard of Care Protection Act, supports legislation to prevent certain Federal health care laws from establishing health care provider standards of care in medical malpractice cases. Realignment - educate policymakers on the driving factors, benefits and implications of hospital realignment. ICD-10 -- discussions of effects of possible delay in implementation of the new ICD-10 coding system. H.R. 3776, the Stark Administrative Simplification Act - supports legislation that would create an alternative, and more appropriate, penalty structure for hospitals that inadvertently incur a technical violation of the Stark self-referral law. CyberSecurity - S. 2588 - legislation to create infrastructure for government and private industry to share cyber threat information; advocate for passage and reasonable approach to new data security mandates. ADAPT Act - HR 3742 - legislation to create incentives and pathways for the expedited development of new drug therapies; advocate for passage as legislative measure to address drug resistance while ensuring preservation of FDA standards for drug safety and efficacy. Assist in review and development of possible revisions to the HIPAA Privacy Rule to allow expanded use of protected health information for research purposes. Advocate for sufficient government resources to support hospital preparedness and response to Ebola and/or other pandemics. Advocate for clarification of hospital compliance with DEAs final rule on disposal of controlled substances, including disposal methodologies, oversight and application.

Client expense: $830,000 · Firm income: Not reported

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

Implementation of the Affordable Care Act of 2010 (Pub. L. 111-148) Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Implementation of the Food and Drug Administration Safety and Innovation Act(FDASIA) Pub.L. 112-144) H.R. 1919 the Safeguarding America's Pharmaceuticals Act of 2013 H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act House Committee on Energy & Commerce 21st Century Cures initiative.

Client expense: Not reported · Firm income: $54,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2500/S. 1137 - Ambulatory Surgical Center Quality and Access Act of 2013 H.R. 1070 - Removing Barriers to Colorectal Cancer Screening Act of 2013 Reform of Medicare payments to ASCs Reform of Medicare regulations dealing with ASCs H.R. 4015 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 H.R. 4209 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013 S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 S. 2157 - Commonsense Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 H.R. 1331 - Electronic Health Records improvement Act H.R. 5556 - Electronic Health Fairness Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act of 2013

Client expense: $163,606 · Firm income: Not reported

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

Strategy development and implementation of federal government relations initiatives; HR 3742, Antibiotic Development to Advance Patient Treatment; FDA compliance issues; HR 1919, Drug Supply Chain Security Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Strategy development and implementation of federal government relations initiatives; HR 3742, Antibiotic Development to Advance Patient Treatment; FDA compliance issues; HR 1919, Drug Supply Chain Security Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 460, Patients' Access to Treatments Act (McKinley) - cost sharing in a specialty drug tier H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (Lynch) - FEHBP prescription drugs H.R. 3116, MODDERN Cures Act (Lance) - innovations in diagnostics, drug exclusivity H.R. 3742, Antibiotic Development to Advance Patient Treatment Act (Gingrey) - treatments for serious or life-threatening diseases S. 214, Preserve Access to Affordable Generics Act (Klobuchar) - access to generic drugs Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,230,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Pension & Welfare Benefits Administration, SENATE, Treasury, Dept of, White House Office

H.R. 460, Patients' Access to Treatments Act (McKinley) - cost sharing in a specialty drug tier. H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (Lynch) - FEHBP prescription drugs. H.R. 3116, MODDERN Cures Act (Lance) - innovations in diagnostics, drug exclusivity. H.R. 3742, Antibiotic Development to Advance Patient Treatment Act (Gingrey) - treatments for serious or life-threatening diseases. S. 214, Preserve Access to Affordable Generics Act (Klobuchar) - access to generic drugs.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Affordable Care Act of 2010 (Pub. L. 111-148), Health Care and Education Reconciliation Act of 2010 (Pub.L. 111-152), Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) Pub.L. 112-144), H.R. 919 the Safeguarding America's Pharmaceuticals Act of 2013, H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act, H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act, House Committee on Energy & Commerce 21st Century Cures initiative. Ongoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints, antibiotic resistance, reimbursement issues for antibiotics, President's Council of Advisors on Science and Technology (PCAST) and their recent report on antibiotic resistance, LPAD (Limited Population Antibacterial Drug) proposal

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3742, Antibiotic Development to Advance Patient Treatment Act of 2013 Issues related to medication errors Issues related to pandemic preparedness Issues related to device regulation Issues related to diagnostic regulation Issues related to biomedical research

Client expense: $250,000 · Firm income: Not reported

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

H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act: Provisions related to DEA scheduling H.R. 5214, To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care H.R. 5657, Fair Access for Safe and Timely (FAST) Generics Act: Provisions related to Risk Evaluation and Mitigation Strategies (REMS) H.R. 5805, Andrea Sloan Compassionate Use Reform and Enhancement Act: Provisions related to expanded access and compassionate use S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress) S. 2917, Adding Ebola to the FDA Priority Review Voucher Program: Provisions related to new proposed voucher program; Public Law No. 113-233 Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Branded Prescription Drug Fee policy issues (79 Fed. Reg. 43631 (July 28, 2014)) 21st Century Cures legislation and policy issues R&D tax credit renewal as part of H.R. 5771, Tax Increase Prevention Act of 2014 Draft legislation relating to prescription drug coverage issues Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA expedited drug approval policy issues Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products [Docket No. FDA-2013-N-0500]: Patient labeling Issues relating to communications about prescription drugs 340B program policy issues Importation policy issues Clinical trial policy issues

Client expense: $3,960,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 1427, the Truth in Healthcare Marketing Act of 2013; all provisions. H.R. 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013; all provisions. Preservation of the in-office ancillary services exemption (IOASE) to the "Stark" law; in general. Concerns regarding 90-day grace period in ACA-subsidized exchange health insurance; in general. Support for ratification of the Convention on the Rights of Persons with Disabilities Treaty. Subsection 2706(a), Title XXVII of the Public Health Service Act, the "Non-Discrimination in Health Care Providers" provision; in general. Review of the Institute of Medicine's (IOM) report on Graduate Medical Education (GME); in general.

Client expense: $150,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

See Next Page For ListingFY 2015 National Defense Autorization Legislation, H.R. 4435 And S. 2410; HR 3742, "Antibiotic Development To Advance Patient Treatment Act (ADAPT); S.932, "Putting Veterans Funding First Act;" S.1999 "Servicemenbers Civil Relief Act Rights Protection Act Of 2014;" Advanced Funding For All Va Programs; Army Policies To Let Officers Who Are Former Enlisted Personnel Retire As Officer Rank/Pay.

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

Government targets: Army, Dept of (Other), HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Section 2706 of the ACA regarding provider non-discrimination Health care coverage and payment options in tax reform discussions Policies affecting nurse practitioner education and workforce Definition of essential health benefits Health information technology and electronic health records Mental health services and violence prevention Draft legislation on reauthorization of the National Quality Forum Coverage and payment for health care services furnished to undocumented immigrant children H.R. 297/S. 1557 - Childrens Hospital GME Support Reauthorization Act H.R. 628/S. 195 - Mental Health in Schools Act H.R. 647 - Achieving a Better Life Experience (ABLE) Act H.R. 669 - Sudden Unexpected Death Data Enhancement and Awareness Act H.R. 1249/S. 1756 - Common Sense Nutrition Disclosure Act H.R. 1281/S. 1417 - Newborn Screening Saves Lives Reauthorization Act H.R. 1427 - Truth in Healthcare Marketing Act H.R. 1791 - Medical Preparedness Allowable Use Act H.R. 1947/H.R. 2642 - Federal Agriculture Reform and Risk Management (FARRM) Act H.R. 2019 - Gabriella Miller Kids First Research Act H.R. 2285 - Strategies to Address Antimicrobial Resistance Act H.R. 2575 - Save American Workers Act H.R. 2663/S. 1422 - To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings H.R. 2833/S. 2278 - Safeguarding Care of Patients Everywhere (SCOPE) Act H.R. 2986 - Protecting Access to Primary Care Act H.R. 3102 - Nutrition Reform and Work Opportunity Act H.R. 3121 - American Health Care Reform Act H.R. 3147 - Food Labeling Modernization Act H.R. 3306/S. 2662 - Telehealth Enhancement Act H.R. 3471/S. 1696 - Women's Health Protection Act H.R. 3527 - Poison Center Network Act H.R. 3717 - Helping Families in Mental Health Crisis Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment (ADAPT) Act H.R. 4118 - Suspending the Individual Mandate Penalty Law Equals (SIMPLE) Fairness Act H.R. 4290 - Wakefield Act H.R. 4574 - Strengthening Mental Health in Our Communities Act H.R. 4631/S. 2449 - Autism Collaboration, Accountability, Research, Education and Support (Autism CARES) Act H.R. 4673 - Bundling and Coordinating Post-Acute Care (BACPAC) Act H.R. 4783 - Promoting Healthy Minds for Safer Communities Act H.R. 4888 - Coordinated Recovery Initiative for Babies (CRIB) Act H.R. 5279 - Sugar-Sweetened Beverages Tax (SWEET) Act S. 264/H.R. 1263 - Excellence in Mental Health Act S. 689 - Mental Health Awareness and Improvement Act S. 696 - Safe Chemicals Act S. 744/H.R. 15 - Border Security, Economic Opportunity, and Immigration Modernization Act S. 954 - Agriculture Reform, Food, and Jobs Act S. 1009 - Chemical Safety Improvement Act S. 1014 - Youth Sports Concussion Act S. 1086 - Safe Child Care Act/Child Care and Development Block Grant Reauthorization Act S. 1152 - Building a Health Care Workforce for the Future Act S. 1417 - Newborn Screening Saves Lives Act S. 1697 - Strong Start for Americas Children Act S. 1758 - Quality Data, Quality Healthcare Act S. 1932/H.R. 3890 - Better Care, Lower Cost Act S. 2047 - Protecting Children from Electronic Cigarette Advertising Act S. 2154 - Emergency Medical Services for Children Reauthorization Act S. 2229 - Expanding Primary Care Access and Workforce Act S. 2434/H.R. 4865 - Family Coverage Act S. 2491 - Medicare Protection Act S. 2581 - Child Nicotine Poisoning Prevention Act S. 2728 - Community-Based Medical Education Act S. 2804 - Family Asthma Act

Client expense: Not reported · Firm income: $23,450

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

H.R. 1074 - National Diabetes Clinical Care Commission Act H.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 1281 - Newborn Screening Saves Lives Reauthorization Act H.R. 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act; provisions related to antibiotics and drug approval H.R. 4260 - Ryan White Patient Equity and Choice Act; provisions related to ADAP H.R. 4847 - End Neglected Tropical Diseases Act S. 539 - National Diabetes Clinical Care Commission Act S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 1417 - Newborn Screening Saves Lives Reauthorization Act S. 2917 - Adding Ebola to the FDA Priority Review Voucher Program Act No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use; issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Implementation issues relating to the Physician Payment Sunshine Act No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products

Client expense: $580,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Medicare Physician Payment Reform - H.R. 4015/S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014, H.R. 4302, Protecting Access to Medicare Act of 2014 Health Care Reform - implementation of the Patient Protection and Affordable Care Act of 2009 Repeal of the Independent Payment Advisory Board, H.R. 351 and S. 351Submitted comments to CMS on Hospital Inpatient Prospective Payment System and Medicare Physician Fee Schedule Final Rules Medicare Liability Reform Imaging - support for In-office Ancillary Services Exception Rescinding the Elimination of Global Surgical Packages - report language in FY 2015 Omnibus Bill, H.R. 83 Letter of support to sponsors of The Antibiotic Development to Advance Treatment Act, H.R. 3742

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act - ensuring that the pipeline for antibiotics is developed in the country. Senator Bennet-Senator Hatch Bill: Promise for Antibiotics and Therapeutics for Health (PATH) Act - ensuring that the pipeline for antibiotics is developed in the country. Implementation and rulemaking related to the Physician Payment Sunshine Act - A Medicare-related provision in the Health Reform Law focused on increasing systemic transparency. Legislative issues that would allow incentives for the discovery and FDA approval of new antibiotics. Regulatory issues surrounding Unique Device Identifiers (UDI) being addressed by the Food and Drug Administration and Congressional oversight. Regulatory issues regarding Meaningful Use 3 regulations being considered by CMS and congressional oversight. Exploring new policies to improve end of life care in America. Issues related to ending prescription drug abuse and diversion.

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Implementation and rulemaking related to the Physician Payment Sunshine Act - A Medicare-related provision in the Health Reform Law focused on increasing systemic transparency. H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act - ensuring that the pipeline for antibiotics is developed in the country. The Senate PATH Act of 2014 - focused on ensuring that the pipeline for antibiotics is developed in the country. Issues related to curbing prescription drug abuse and diversion.

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Implementation of the "GAIN" provisions/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation HR 3742 -- the Antibiotic Development to Advance Patient Treatment Act of 2013 H.R.4187 -- Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 antibiotic product incentives for possible inclusion in the House "21st Century Cures" effort

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health LegislationH.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 1281 - Newborn Screening Saves Lives Reauthorization Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act; provisions related to antibiotics and drug approval H.R. 4260 - Ryan White Patient Equity and Choice Act; provisions related to ADAP H.R. 4847 - End Neglected Tropical Diseases Act S. 539 - National Diabetes Clinical Care Commission Act S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 1417 - Newborn Screening Saves Lives Reauthorization Act

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Section 2706 of the ACA regarding provider non-discrimination Health care coverage and payment options in tax reform discussions Policies affecting nurse practitioner education and workforce Definition of essential health benefits Health information technology and electronic health records Mental health services and violence prevention Draft legislation on reauthorization of the National Quality Forum Coverage and payment for health care services furnished to undocumented immigrant children H.R. 297/S. 1557 - Childrens Hospital GME Support Reauthorization Act H.R. 628/S. 195 - Mental Health in Schools Act H.R. 669 - Sudden Unexpected Death Data Enhancement and Awareness Act H.R. 1249/S. 1756 - Common Sense Nutrition Disclosure Act H.R. 1281/S. 1417 - Newborn Screening Saves Lives Reauthorization Act H.R. 1427 - Truth in Healthcare Marketing Act H.R. 1791 - Medical Preparedness Allowable Use Act H.R. 1947/H.R. 2642 - Federal Agriculture Reform and Risk Management (FARRM) Act H.R. 2019 - Gabriella Miller Kids First Research Act H.R. 2285 - Strategies to Address Antimicrobial Resistance Act H.R. 2575 - Save American Workers Act H.R. 2663/S. 1422 - To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings H.R. 2833/S. 2278 - Safeguarding Care of Patients Everywhere (SCOPE) Act H.R. 2986 - Protecting Access to Primary Care Act H.R. 3102 - Nutrition Reform and Work Opportunity Act H.R. 3121 - American Health Care Reform Act H.R. 3147 - Food Labeling Modernization Act H.R. 3306/S. 2662 - Telehealth Enhancement Act H.R. 3471/S. 1696 - Women's Health Protection Act H.R. 3527 - Poison Center Network Act H.R. 3717 - Helping Families in Mental Health Crisis Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment (ADAPT) Act H.R. 4118 - Suspending the Individual Mandate Penalty Law Equals (SIMPLE) Fairness Act H.R. 4290 - Wakefield Act H.R. 4574 - Strengthening Mental Health in Our Communities Act H.R. 4631/S. 2449 - Autism Collaboration, Accountability, Research, Education and Support (Autism CARES) Act H.R. 4673 - Bundling and Coordinating Post-Acute Care (BACPAC) Act H.R. 4783 - Promoting Healthy Minds for Safer Communities Act H.R. 4888 - Coordinated Recovery Initiative for Babies (CRIB) Act H.R. 5279 - Sugar-Sweetened Beverages Tax (SWEET) Act S. 264/H.R. 1263 - Excellence in Mental Health Act S. 689 - Mental Health Awareness and Improvement Act S. 696 - Safe Chemicals Act S. 744/H.R. 15 - Border Security, Economic Opportunity, and Immigration Modernization Act S. 954 - Agriculture Reform, Food, and Jobs Act S. 1009 - Chemical Safety Improvement Act S. 1014 - Youth Sports Concussion Act S. 1086 - Safe Child Care Act/Child Care and Development Block Grant Reauthorization Act S. 1152 - Building a Health Care Workforce for the Future Act S. 1417 - Newborn Screening Saves Lives Act S. 1697 - Strong Start for Americas Children Act S. 1758 - Quality Data, Quality Healthcare Act S. 1932/H.R. 3890 - Better Care, Lower Cost Act S. 2047 - Protecting Children from Electronic Cigarette Advertising Act S. 2154 - Emergency Medical Services for Children Reauthorization Act S. 2229 - Expanding Primary Care Access and Workforce Act S. 2434/H.R. 4865 - Family Coverage Act S. 2491 - Medicare Protection Act S. 2581 - Child Nicotine Poisoning Prevention Act S. 2728 - Community-Based Medical Education Act S. 2804 - Family Asthma Act

Client expense: Not reported · Firm income: $23,450

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; and community-based public health interventions and prescription drug abuse. 1. Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148)2.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6.Delivering Antimicrobial Transparency in Animals Act of 2013 (H.R. 820) 7.Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 8.Healthier Lifestyles and Prevention America Act (S. 39) 9.Promoting Health as Youth Skills in Classrooms and Life Act (S. 392/H.R. 2160) 10.Medicare Diabetes Prevention Act (S. 452/H.R. 962) 11.Personal Health Investment Today Act (H.R. 956) 12.A bill to provide for a sequester replacement (S. 16/S. 799) 13.American Family Economic Protection Act of 2013 (S. 388) 14.Consolidated and Further Continuing Appropriations Act, 2013 (H.R. 933/Public Law 113-6) 15.Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 16.National Diabetes Clinical Care Commission Act (H.R. 1074/S. 539) 17.Physical Activity Guidelines for Americans Act (S. 531/H.R. 2179) 18.Firearm Safety and Public Health Research Act (H.R. 321) 19.Energy Consumers Relief Act (S. 1363/H.R. 1582) 20.Common Sense Nutrition Disclosure Act (H.R. 1249/S. 1756) 21.Improve Nutrition Program Integrity and Deficit Reduction Act (S. 458/H.R. 1510) 22.A bill to amend the Food and Nutrition Act of 2008 to improve the supplemental nutrition assistance program (S. 762/H.R. 1657) 23.Agriculture Reform, Food, and Jobs Act (S. 954/H.R. 2498) 24.Federal Agriculture Reform and Risk Management Act (H.R. 1947) 25.FIT Kids Act (S. 1033/H.R. 2178) 26.Strengthening Americas Schools Act (S. 1094) 27.Access to Quality Diabetes Education Act (S. 945/H.R. 1274) 28.Fit to Serve Act (S. 976) 29.Climate Change Health Protection and Promotion Act (H.R. 2023/S. 2864) 30.Treat and Reduce Obesity Act (S. 1184 / H.R. 2415) 31.Student Success Act (H.R. 5) 32.To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act (H.R. 45) 33.Medicare Better Health Rewards Program Act (S. 1228/H.R. 2524) 34.Senate FY14 Labor, Health and Human Services, and Education Bill (S. 1284) 35.House of Representatives FY14 Labor, Health and Human Services, and Education Bill 36.Pharmacy Compounding Quality and Accountability Act (S. 959) 37.Safeguarding Americas Pharmaceuticals Act (H.R. 1919) 38.Implementation of Drug Supply Chain Security Act (P.L. 113-54) 39.Preservation of Antibiotics for Medical Treatment Act (H.R. 1150)/Preventing Antibiotic Resistance Act of 2013 (S. 1256) 40.Healthy Families Act (H.R. 1286/S. 631) 41.FY2014 Continuing Resolution (H.J. Res. 59) 42.Pharmaceutical Quality, Security and Accountability Act (S. 959) 43.Energy Consumers Relief Act (S. 1363/H.R. 1582) 44.Increasing the Safety of Prescription Drug Use Act (S. 1657) 45.National Energy Tax Repeal Act (S. 1324) 46.Saving Coal Jobs Act of 2013 (S. 1514/H.R. 5077) 47.Community Parks Revitalization Act (H.R. 2424) 48.A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (S. 1422/H.R. 2663) 49.School-based Health Centers Program Reauthorization Act of 2013 (H.R. 2632) 50.Nutrition Reform and Work Opportunity Act (H.R. 3102) 51.Health Equity and Accountability Act (H.R. 5294) 52.Secure America for Education (SAFE) in Our Schools Act of 2013 (H.R. 3158) 53.Continuing Appropriations Resolution, 2014 (H.J. Res 59) 54.Continuing Resolution FY 2014 (HR 2775, PL 113-46) 55.A bill to amend title 23, United States Code, with respect to the establishment of performance measures for the highway safety improvement program, and for other purposes. (H.R. 3493/S. 1708) 56.The Farm Bill (S. (S. 954/H.R. 2498; H.R. 1947, and H.R. 3102, Public Law 113-79) 57.Better Care, Lower Cost Act (S. 1932/H.R. 3890) 58.Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) (H.R. 3742) 59.The Consolidated Appropriations Act of 2014 (H.R. 3547/Public Law 113-76 60.Strategies to Address Antimicrobial Resistance (STAAR) Act (S. 2236/H.R. 2285) 61.New Opportunities for Bicycling and Pedestrian Infrastructure Financing Act of 2014 (H.R. 3978) 62.Eliminating Disparities in Diabetes Prevention, Access, and Care Act (H.R. 3322) 63.Electricity Security and Affordability Act (S. 1905/H.R. 3826) 64.Stop Overdose Stat Act (HR 4169) 65.Overdose Prevention Act (S 2755) 66.Opioid Overdose Reduction Act (S. 2092/H.R. 4288) 67.Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 (DISARM Act) (H.R. 4187) 68.Child Care and Development Block Grant Act of 2014 (S. 1086) 69.Departments of Labor, Health and Human Services and Education And Related Agencies Fiscal Year 2015 Appropriations Bill (including H.R. 5464) 70.Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (S. 2389 / H.R. 4800) 71.Department of the Interior, Environment, and Related Agencies appropriations legislation, 2015 (including H.R. 5171) 72.MAP-21 Reauthorization Act (S. 2322) 73.Stop Subsidizing Childhood Obesity Act (S. 2342/H.R. 2831) 74.ENRICH Act (H.R. 4427) 75.Healthy Kids Outdoors Act of 2014 (S. 2367/H.R. 4706) 76.Summer Meals Act of 2014 (S. 2527/HR. 5012) 77.Long-Term SCORE Act (H.R. 4444) 78.American Cures Act (S. 2115/H.R. 4384) 79.A joint resolution to disapprove a rule of the Environmental Protection Agency relating to greenhouse gas emissions from electric utility generating units. (S.J. Res 30) 80.Fit for Life Act of 2014 (H.R.4765) 81.School Food Modernization Act (S. 2210/H.R. 1783) 82.Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 2014/H.R. 4325) 83.Pedestrian Safety Act of 2014 (S. 2284) 84.Safe Streets Act of 2014 (S. 2004/H.R. 2468) 85.The Recovery Enhancement for Addiction Treatment Act (S. 2645) 86.FY 2015 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws (including H.R. 5016) 87.Vector-Borne Disease Research Accountability and Transparency Act (H.R. 4701) 88.Highway and Transportation Funding Act of 2014 (H.R. 5021/Public Law 113-520) 89.Full-Service Community Schools Act of 2014 (H.R. 5168) 90.PREPARE Act of 2014 (H.R. 5314) 91.Waters of the United States Regulatory Overreach Protection Act of 2014 (S. 2496/H.R. 5078) 92.American Energy Solutions for Lower Costs and More American Jobs Act (H.R.

Client expense: $38,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

H.R. 2500/S. 1137 - Ambulatory Surgical Center Quality and Access Act of 2013 H.R. 1070 - Removing Barriers to Colorectal Cancer Screening Act of 2013 Reform of Medicare payments to ASCs Reform of Medicare regulations dealing with ASCsH.R. 4015 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 H.R. 4209 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S.1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013 S. 2110 - Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 S.2157 - Commonsense Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 H.R. 1331 - Electronic Health Records improvement Act H.R. 5556 - Electronic Health Fairness Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act of 2013

Client expense: $169,779 · Firm income: Not reported

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

H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act: Provisions related to DEA scheduling H.R. 5214, To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care H.R. 5657, Fair Access for Safe and Timely (FAST) Generics Act: Provisions related to DEA scheduling S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking 21st Century Cures legislation and policy issues Draft legislation relating to prescription drug coverage issues Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues Importation policy issues Clinical trial policy issues

Client expense: $3,680,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Issues related to safe handling of hazardous drugs Issues related to pandemic preparedness H.R. 3742, Antibiotic Development to Advance Patient Treatment Act of 2013 Issues related to device regulation

Client expense: $200,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Research funding, including; FY15 LHHS Appropriations bill FY15 Mil/Con/VA Appropriations bill HR4486 FY15 Interior/Environment bill HF5171 ADAPT Act, H.R. 3742

Client expense: $160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)

Implementation of the Affordable Care Act of 2010 (Pub. L. 111-148) Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) Pub.L. 112-144) H.R. 1919 the Safeguarding America's Pharmaceuticals Act of 2013 H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act H.R. 4187, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act

Client expense: Not reported · Firm income: $54,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues surrounding the enactment or repeal of the Affordable Care Act, including IPAB and ACOs. Medicare reimbursement (SGR) reform for providers. FDA issues and Issues surrounding the tissue bank industry. HR 351 and S. 351: Protecting Seniors' Access to Medicare Act (IPAB repeal). HR 2810, the Medicare Patient Access and Quality Improvement Act (SGR reform). H.R. 1984, The Breast Cancer Patient Education Act. HR 1761/S 1318, the Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act. Training Tomorrows Doctors Today Act, H.R. 1201 and The Resident Physician Shortage Reduction Act of 2013 (S. 577 ). The Palliative Care and Hospice Education and Training Act (HR 1339/S.641). Issues and regulations governing the use and deployment of speech generating devices (SGDs). Issues involving Value Based Insurance Design or V-BID. Antibiotic Development to Advance Patient Treatment (ADAPT) Act. HR 3742.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

Implementation of the "GAIN" provisions/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation HR 3742 -- the Antibiotic Development to Advance Patient Treatment Act of 2013 H.R.4187 -- Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 antibiotic product incentives for possible inclusion in the House "21st Century Cures" effort

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2529, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2014, all provisions S. 2645, Recovery Enhancement for Addiction Treatment (TREAT) Act, all provisions H.R. 3229, Indian Health Service Advance Appropriations Act of 2013, all provisions S. 1570, Indian Health Service Advance Appropriations Act of 2013, all provisionsH.R. 4843, Native Contract and Rate Expenditure Act of 2014, all provisions H.R. 1701, Cutting Costly Codes Act of 2013, all provisions S. 972, Cutting Costly Codes Act of 2013, all provisions H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013, all provisions ACA Implementation Prescription requirements for OTC medications Electronic Health Records Meaningful Use Regulations Opioid abuse, diversion control and treatment Prescription drug abuse/pain management/prescriber education Telemedicine ICD-10 Repeal CPT HIPAA Health Care Data Open Payments Regulations (Sunshine Act) Laboratory Developed Tests Personalized Medicine 21st Century Cures Initiative Mental Health Diabetes Nutrition Labeling Drug Compounding Biosimilars Clinical Data Registries Exchanges

Client expense: $4,230,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE, Veterans Affairs, Dept of (VA), White House Office

Health Reform Implementation -The Affordable Care Act enacted comprehensive reform of the health care delivery and payments systems in the United States. Specifically, FAH is advocating on implementation issues related to delivery reform affecting hospitals and insurance reform. HITECH Act - Implementation of meaningful use and privacy and security provisions in HITECH Act of 2009. Group Purchasing Organization Regulations - Monitor policy proposals that would result in additional federal regulation of Group Purchasing Organizations. H.R. 1473, the Standard of Care Protection Act, supports legislation to prevent certain Federal health care laws from establishing health care provider standards of care in medical malpractice cases. Realignment - educate policymakers on the driving factors, benefits and implications of hospital realignment. ICD-10 -- discussions of effects of possible delay in implementation of the new ICD-10 coding system. H.R. 3776, the Stark Administrative Simplification Act - supports legislation that would create an alternative, and more appropriate, penalty structure for hospitals that inadvertently incur a technical violation of the Stark self-referral law. CyberSecurity - S. 2588 - legislation to create infrastructure for government and private industry to share cyber threat information; advocate for passage and reasonable approach to new data security mandates. ADAPT Act - HR 3742 - legislation to create incentives and pathways for the expedited development of new drug therapies; advocate for passage as legislative measure to address drug resistance while ensuring preservation of FDA standards for drug safety and efficacy.

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, White House Office

Strategy development and implementation of federal government relations initiatives; HR 3742, Antibiotic Development to Advance Patient Treatment; FDA compliance issues; HR 1919, Drug Supply Chain Security Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Strategy development and implementation of federal government relations initiatives; HR 3742, Antibiotic Development to Advance Patient Treatment; FDA compliance issues; HR 1919, Drug Supply Chain Security Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1074- National Diabetes Clinical Care Commission Act H.R. 1248 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 1281 - Newborn Screening Saves Lives Reauthorization Act H.R. 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act; provisions related to antibiotics and drug approval H.R. 4260 - Ryan White Patient Equity and Choice Act; provisions related to ADAP H.R. 4847 - End Neglected Tropical Diseases Act S. 539 - National Diabetes Clinical Care Commission Act S. 610 - Family Health Care Flexibility Act; provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1165 - Access to Appropriate Immunizations for Veterans Act of 2013; provisions related to extending VA performance measure to include all federally recommended vaccine S. 1417 - Newborn Screening Saves Lives Reauthorization Act No bill # assigned - Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking No bill # assigned - 21st Century Cures Initiative and related policy issues No bill # assigned - FDA special medical use; issues related to limited population antibacterial drug approval pathway No bill # assigned - FDA accelerated approval policy issues No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues No bill # assigned - Implementation issues relating to the Physician Payment Sunshine Act No bill # assigned - Support for COPD national action plan No bill # assigned - FDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA No bill # assigned - FDA proposed rule regarding electronic distribution of cContent of Labeling for Human Prescription Drug and Biological products

Client expense: $1,140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 1427, the Truth in Healthcare Marketing Act of 2013; all provisions. H.R. 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013; all provisions. Preservation of the in-office ancillary services exemption (IOASE) to the "Stark" law; in general. Concerns regarding 90-day grace period in ACA-subsidized exchange health insurance; in general. Support for ratification of the Convention on the Rights of Persons with Disabilities Treaty. Subsection 2706(a), Title XXVII of the Public Health Service Act, the "Non-Discrimination in Health Care Providers" provision; in general. Review of the Institute of Medicine's (IOM) report on Graduate Medical Education (GME); in general.

Client expense: $178,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

Implementation of the "GAIN" provisions/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; HR 3742- the Antibiotic Development to Advance Patient Treatment Act of 2013; H.R. 4187 - Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014;antibiotic product incentives for possible inclusion in the House "21st Century Cures" effort

Client expense: $450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislative issues that would allow incentives for the discovery and FDA approval of new antibiotics. Regulatory issues surrounding Unique Device Identifiers (UDI) being addressed by the Food and Drug Administration, CMS and Congressional Oversight. Implementation and rulemaking related to the Physician Payment Sunshine Act and the Open Payments system. Issues related to ending prescription medication abuse. H.R. 3742 Antibiotic Development to Advance Patient Treatment Act - ensuring that the pipeline for antibiotics is developed in the country.

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 3742 - Antibiotic Development to Advance Patient Treatment Act - ensuring that the pipeline for antibiotics is development in the country. Other issues related to improving availability and access to new antibiotics. Issues related to prescription drug abuse in the Medicare and Medicaid programs.

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 3742 HR 3204

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Biosimilars Colombia Biologics Regulations Naming Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Vaccine Access/Financing Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Implementation of Affordable Care Act Program Implementation & Oversight Departments of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2015 Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Medicaid Pricing and Rebates Implementation of Affordable Care Act H.R. 1416: The Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) (Non-Funding) Program Implementation Sequestration of PDUFA Fees Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade & Investment Partnership Regulatory Harmonization/TransparencyDrug Evaluation and Review Implementation of the FDA Safety and Innovation Act 21st Century Cures Initiative Compassionate Use/Expanded Access FDA Proposed Rule on Changes to Drug Labeling Special Medical Use/Limited Population Drugs H.R. 4475: Compassionate Freedom of Choice Act H.R. 2090: The Patient Choice Act H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure EU Policies Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Compounding Sunshine Act Implementation Medicare Physician Payment Sustainable Growth Rate Formula S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 Drug Repurposing H.R. 4287/S.2150: Independent Innovator and Repurposing Act

Client expense: $2,110,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015Genetically Engineered (GE) Animals Labeling GE Animal Models of Human Disease FDA Approval Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 Amendment on GE Salmon Labeling Amendment to Restrict FDA Approval of GE Salmon Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Review and Labeling of Food Derived From Biotechnology Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R. 4432: Safe and Accurate Food Labeling Act Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act 21st Century Cures Initiative Compassionate Use/Expanded Access FDA Proposed Rule on Changes to Drug Labeling Special Medical Use/Limited Population Drugs H.R. 4475: Compassionate Freedom of Choice Act H.R. 2090: The Patient Choice Act H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Biosimilars Colombia Biologics Regulations Naming Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution USDA/APHIS Agricultural Biotechnology Regulations Coexistence of Production Systems Efficient Science-Based Review of Biotech Products Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Compounding Sunshine Act Implementation

Client expense: $2,110,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

Implementation of FDASIA and GDUFA, Counterfeit Drugs/Import Safety, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation Mitigation Strategies, Biosimilar Naming, Electronic Labeling for Pharmaceuticals, H.R. 2725, FDA Safety over Sequestration Act, S. 1413, FDA User Fee Protection Act, H.R. 2985, Combination Drug Development Incentive Act, H.R. 3742, Antibiotic Development to Advance Patient Treatment Act of 2013, H.R. 486, Stop Tampering of Prescription Pills Act of 2013H.R. 4437, Generic Drug Pricing Fairness Act

Client expense: $655,940 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Health care reform implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing program issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACAs expansion of covered 340B entitiesOngoing discussions surrounding next steps for protecting and promoting incentives for the development of resistant pathogens including breakpoints Antibiotic resistance among elderly population Reimbursement issues for antibiotics HR 4187, DISARM, Developing Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 Implementation of Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub.L. 112-144) S. 957, Drug Supply Chain Security Act; H.R. 1919 the Safeguarding America's Pharmaceuticals Act of 2013 S. 959, Pharmaceutical Compounding Quality and Accountability Act H.R. 3742, Antibiotic Development to Advance Patient Treatment (ADAPT) Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the GAIN provisions/Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA) PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation HR 3742 the Antibiotic Development to Advance Patient Treatment Act of 2013 HR 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; and community-based public health interventions. 1. Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148)1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Middle Class Tax Relief and Job Promotion Act (H.R. 3630) 3.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 4.Implementation of Pandemic and All-Hazards Preparedness Act (Public Law 109-417) 5.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 6.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 7.Delivering Antimicrobial Transparency in Animals Act of 2013 (H.R. 820) 8.Animal Drug and Animal Generic Drug User Fee Act (S. 622/H.R.___) 9.Healthier Lifestyles and Prevention America Act (S. 39) 10.Promoting Health as Youth Skills in Classrooms and Life Act (S. 392) 11.Medicare Diabetes Prevention Act (S. 452/H.R. 962) 12.Personal Health Investment Today Act (H.R. 956) 13.A bill to provide for a sequester replacement (S. 16) 14.American Family Economic Protection Act of 2013 (S. 388) 15.Consolidated and Further Continuing Appropriations Act, 2013 (H.R. 933) 16.Regulations From the Executive in Need of Scrutiny Act of 2013 (S. 15 / H.R. 367) 17.To repeal the Prevention and Public Health Fund (H.R. 1099) 18.Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 19.National Diabetes Clinical Care Commission Act (H.R. 1074/S. 539) 20.Physical Activity Guidelines for Americans Act (S. 531) 21.Firearm Safety and Public Health Research Act (H.R. 321) 22.Helping Sick Americans Now Act (H.R. 1549) 23.Energy Consumers Relief Act (H.R. 1582) 24.Common Sense Nutrition Disclosure Act (H.R. 1249) 25.Improve Nutrition Program Integrity and Deficit Reduction Act (S. 458/H.R. 1510) 26.A bill to amend the Food and Nutrition Act of 2008 to improve the supplemental nutrition assistance program (S. 762/H.R. 1657) 27.Agriculture Reform, Food, and Jobs Act (S. 954/H.R. 2498) 28.Federal Agriculture Reform and Risk Management Act (H.R. 1947) 29.FIT Kids Act (S. 1033/H.R. 2178) 30.Strengthening Americas Schools Act (S. 840) 31.Access to Quality Diabetes Education Act (S. 945/H.R. 1274) 32.Fit to Serve Act (S. 976) 33.Climate Change Health Protection and Promotion Act (H.R. 2023) 34.Treat and Reduce Obesity Act (S. 1184 / H.R. 2415) 35.Student Success Act (H.R. 5) 36.To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act (H.R. 45) 37.Medicare Better Health Rewards Program Act (S. 1228/H.R. 2524) 38.Senate FY14 Labor, Health and Human Services, and Education Bill 39.House of Representatives FY14 Labor, Health and Human Services, and Education Bill 40.Pharmacy Compounding Quality and Accountability Act (S. 959) 41.Safeguarding Americas Pharmaceuticals Act (H.R. 1919) 42.Drug Supply Chain Security Act (S. 957) 43.Preservation of Antibiotics for Medical Treatment Act (H.R. 1150)/Preventing Antibiotic Resistance Act of 2013 (S. 1256) 44.Healthy Families Act (H.R. 1286/S. 631) 45.FY2014 Continuing Resolution (H.J. Res. 59) 46.Drug Quality and Security Act (H.R. 3204) 47.Pharmaceutical Quality, Security and Accountability Act (S. 959) 48.Energy Consumers Relief Act (H.R. 1582) 49.Increasing the Safety of Prescription Drug User Act (not yet introduced proposed by Sen. Udall-NM) 50.National Energy Tax Repeal Act (S. 1324)51.Saving Coal Jobs Act of 2013 (S. 1514) 52.Community Parks Revitalization Act (H.R. 2424) 53.A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (S. 1422/H.R. 2663) 54.School-based Health Centers Program Reauthorization Act of 2013 (H.R. 2632) 55.Nutrition Reform and Work Opportunity Act (H.R. 3102) 56.Health Equity and Accountability Act (not yet introduced) 57.Secure America for Education (SAFE) in Our Schools Act of 2013 (H.R. 3158) 58.Continuing Appropriations Resolution, 2014 (H.J. Res 59) 59.Continuing Resolution FY 2014 (HR 2775, PL 113-46) 60.A bill to amend title 23, United States Code, with respect to the establishment of performance measures for the highway safety improvement program, and for other purposes. (H.R. 3493/S. 1708) 61.The Farm Bill (S. (S. 954/H.R. 2498; H.R. 1947, and H.R. 3102) 62.Better Care, Lower Cost Act (S. 1932/H.R. 3890) 63.Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) (H.R. 3742) 64.Preventing Antibiotic Resistance Act (S. 1256) 65.The Consolidated Appropriations Act of 2014 66.Strategies to Address Antimicrobial Resistance (STAAR) Act 67.New Opportunities for Bicycling and Pedestrian Infrastructure Financing Act of 2014 (H.R. 3978) 68.Eliminating Disparities in Diabetes Prevention, Access, and Care Act (H.R. 3322) 69.Electricity Security and Affordability Act (HR 3826) 70.Stop Overdose Stat Act (HR 4169) and Senate companion bill soon to be introduced by Senator Reed 71.Opioid Overdose Reduction Act (S. 2092/H.R. 4288) 72.Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 (DISARM Act) (H.R. 4186) 73.Child Care and Development Block Grant Act of 2014 (S. 1086) 74.Departments of Labor, Health and Human Services and Education And Related Agencies Fiscal Year 2015 Appropriations Bill 75.Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (S. 2389 / H.R. 4800) 76.Department of the Interior, Environment, and Related Agencies appropriations legislation, 2015 77.MAP-21 Reauthorization Act (S. 2322) 78.Stop Subsidizing Childhood Obesity Act (S. 2342/H.R. 2831) 79.ENRICH Act (H.R. 4427) 80.Agricultural Act of 2014 (Public Law 113-79) 81.Healthy Kids Outdoors Act of 2014 (S. 2367/H.R. 4706) 82.A bill to amend the Richard B. Russell National School Lunch Act to improve the efficiency of summer meals (S. 2527) 83.Summer Meals Act of 2014 (HR. 5012) 84.Long-Term SCORE Act (H.R. 4444) 85.American Cures Act (S. 2115/H.R. 4384) 86.A joint resolution to disapprove a rule of the Environmental Protection Agency relating to greenhouse gas emissions from electric utility generating units. (S.J. Res 30) 87.Fit for Life Act of 2014 (H.R.4765) 88.School Food Modernization Act (S. 2210/H.R. 1783) 89.Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 2014/H.R. 4325) 90.Pedestrian Safety Act of 2014 (S. 2284) 91.Safe Streets Act of 2014 (S. 2004/H.R. 2468) 92.The Recovery Enhancement for Addiction Treatment Act (not yet introduced, by Senator Markey) 93.FY 2015 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws

Client expense: $38,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)