Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015

Tax incentives on research into antibiotics, antifungals, and infectious disease diagnostic tests. H.R. 3539.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Pricing Program ----Implementation of Affordable Care Act ---Program Implementation & Oversight ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act Biosimilars ---Biosimilar User Fee Act Reauthorization and Implementation ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Access to Samples for Testing ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Evaluation and Review ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---FDA Proposed Rule on Changes to Drug Labeling ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act Drug Importation ---H.R.5054 - S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325-S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products -- --CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Senate Innovation for Healthier Americans ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---- S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 1878: Advancing Hope Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act UN High Level Commission on Access to Medicines Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---Senate Chronic Care Working Group Proposals ---Vaccine Injury Compensation Program ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Vaccines and Infectious Diseases - General ---H.R. 3299: Strengthening Public Health Emergency Response Act ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Combating Antibiotic-Resistant Bacteria (CARB) Initiative Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Vial and Dose Size Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Government Price Reporting ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization

Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---S. 2271: The Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms ---Refundable R&D Credit

Client expense: $2,310,000 · Firm income: Not reported

S.2511 Improving Health Information Technology Act H.R. 6 21st Century Cures Act H.R 5447/S. 3060 Small Business Health Care Relief Act of 2016 S. 2744 Genetic Research Privacy Protection Act H.R. 5273 Helping Hospitals Improve Patient Care Act S. 2713 Advancing Precision Medicine Act S. 1878 The Advancing Hope Act S. 1767 Combination Products Innovation Act S. 1077 Advancing Breakthrough Medical Devices for Patients Act S. 2512 Adding Zika Virus to the FDA Priority Review voucher Program Act S. 1101 Medical Electronic Data Technology Enhancement for Consumers Health Act S. 1597 Patient Focused Impact Assessment Act S. 2055 Medical Countermeasures Innovation Act S. 2873 Expanding Capacity for Health Outcomes (ECHO) Act H.R. 3081/ S. 1778 TELEmedicine for MEDicare (TELE-MED) Act H.R. 4442/S. 2484 CONNECT for Health Act H.R. 1192 National Diabetes Clinical Care Commission Act S. 620, H.R. 1189 Preserving Employee Wellness Programs Act H.R. 4878 Better Care, Lower Cost Act H.R. 5273 Helping Hospitals Improve Patient Care Act H.R. 4774 Training Tomorrows Doctors Today Act S. 2671, H.R.4732 Advancing Medical Resident Training in Community Hospitals Act S. 314, H.R. 592 Pharmacy and Medically and Underserved Areas Enhancement Act H.R.1314 Bipartisan Budget Act H.R. 1190/S. 141 Protecting Seniors' Access to Medicare Act H.R. 160/S. 149 Protect Medical Innovation Act H.R. 4732/ S. 2671 Advancing Medical Resident Training in Community Hospitals Act H.R. 2061, Equitable Access to Care and Health (EACH) Act H.R. 2446 To amend title XIX of the Social Security Act to require the use of electronic visit verification for personal care services furnished under the Medicaid program, and for other purposes. H.R. 2603/S. 1475 Saving Lives, Saving Costs Act H.R. 2646 Helping Families in Mental Health Crisis Act H.R. 2704/H.R. 4212/S.704 Community Based Independence for Seniors Act H.R. 2878/S. 1461 To provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015. H.R.2911/S. 1697 Small Business Healthcare Relief Act H.R. 3539 Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act H.R. 3660 Preventive Health Savings Act H.R. 3716 Ensuring Terminated Providers are Removed from Medicaid and CHIP Act H.R. 3762 Restoring Americans Healthcare Freedom Reconciliation Act H.R. 3821 Medicaid Directory of Caregivers Act H.R. 5380 Telehealth Parity Act S. 139 Ensuring Access to Clinical Trials Act S. 2023 Prescription Drug Affordability Act S. 2030 Advancing Targeted Therapies for Rare Diseases Act S. 2045 Middle Class Health Benefits Tax Repeal Act S. 2075 American Worker Health Care Tax Relief Act S. 2153 Provider Payment Sunshine Act S. 2187 FDA Regulatory Efficiency Act S. 754 Cyber security Information Sharing Act (CISA) S.2104 Preserving Medicare Advantage for all Medicare Beneficiaries Act

Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Drug Dependence (general); HIV Screening (general); Gynecologic Cancer (general); Gynecologic devices (general); Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality and Morbidity (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); Meaningful Use Stage 3; H.R. 3940, Meaningful Use Hardship Relief Act; H.R.4695/S. 466, Quality Care for Moms and Babies Act; H.R. 3865/S.2542, Cradle Act; H.R. 836/S. 884, Health Care Safety Net Enhancement Act; H.R. 865, Good Samaritan Health Professionals Act; H.R. 2603/S. 1475, Saving Lives, Saving Costs Act; H.R. 4774, Training Tomorrows Doctors Today Act; H.R. 3658/S. 84, GEDI Act; H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016; H.R. 1209/S.628 Improving Access to Maternity Care Act; Implementation of H.R. 1462/S. 799, Protecting our Infants Act; H.R. 3691/S. 2226, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 2972, Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act; H.Res. 461, Establishing a Select Investigative Panel of the Committee on Energy and Commerce; Fetal Tissue Research (General); H.R. 3706/S.1911, Reach Every Mother and Child Act of 2016; H.Res. 558/S.Res. 327, Condemning Violence That Targets Healthcare for Women; H.R. 4924/S.48, Prenatal Nondiscrimination Act (PRENDA) of 2016; Senate Biomedical Innovations Packages (general); S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act; S.2742, Promoting Biomedical Research and Public Health for Patients Act; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3652/S. 674, 21st Century Womens Health Act; S. 1532, Affordability is Access Act; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3235/S. 2311, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); and H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act; H.R. 5369, Healthy Start Reauthorization Act; S. 3070, Hygiene Assistance for Families of Infants and Toddlers Act of 2016; H.R. 5219 Safe Medications for Moms and Babies Act of 2016; H.R. 953/S. 524, Comprehensive Addiction and Recovery Act; H.R. 2646, Helping Families in Mental Health Crisis Act; S. 2680, Mental Health Reform Act; H.R. 3537, Synthetic Drug Control Act; H.R. 4499/S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act; H.R. 4874, Prevent Abuse by Using Interstate Exchange Act; H.R. 2805/S. 1134, Heroin and Prescription Opioid Abuse, Prevention, Education, and Enforcement Act; H.R. 2654/S. 1512, Pregnant Workers Fairness Act; H.R. 1706/S.2765, Real Education for Healthy Youth Act.

Tax incentives on research into antibiotics, antifungals, and infectious disease diagnostic tests. H.R. 3539.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biosimilars --Coding --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Patent Certification --Brazil Biologics Regulations Funding for National Institutes of Health --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Centers for Disease Control and Prevention Vaccine Programs --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 340B Drug Pricing Program --Implementation of Affordable Care Act --Program Implementation & Oversight --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Drug Importation --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) Reimbursement for Innovative Products --Medicare Part B Physician-Administered Products --Medicare Part D Prescription Drug Program: ----CMS Proposed Rule on Protected Classes --Value-based Contracting and Communications Drug Evaluation and Review --Compassionate Use/Expanded Access --FDA Proposed Rule on Changes to Drug Labeling --Implementation of the FDA Safety and Innovation Act --Reauthorization of the Prescription Drug User Fee Act --Special Medical Use/Limited Population Drug ---- ADAPT Act (House Discussion Draft) Senate Innovation for Healthier Americans --Biomarkers and Regulatory Science Improvements --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives ----S. 195: PATH Act --Communication with Healthcare Professionals and Payors --Priority Review Voucher Programs Priority Review of Generic Drugs ----S. 2615: Increasing Competition in Pharmaceuticals Act Vaccines and Infectious Diseases - General Government Price Reporting --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Gene Editing Technologies --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Drug Manufacturing, Quality & Distribution --Supply Chain Integrity and Traceability Affordable Care Act Implementation --Third Party Support of Patient Premiums and Cost-Sharing Obligations Combating Antibiotic-Resistant Bacteria (CARB) Initiative Vaccine Access/Financing --Adult Immunization (Senate Discussion Draft) --Implementation of Affordable Care Act --Senate Chronic Care Working Group Proposals --Vaccine Injury Compensation Program TransPacific Partnership --Data and Intellectual Property Protection for Pharmaceuticals --Reimbursement Transparency Orphan Drug Act Tax Credit UN Commission on Access to Medicines

Biofuels (Non-Funding) --Production Tax Credit Extension --S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----Franken-Grassley Amendment Research & Development Tax Credit Reforms --Extension --Permanency --Refundable R&D Credit Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Tax Reform --Innovation Box / Patent Box Orphan Drug Act Tax Credit Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Inversions --Financial Services and General Government Appropriations Act for FY 2017 Renewable Chemicals/Bio-based Products (Non-Funding) --Investment Tax Credit for Renewable Chemicals and Bio-based Products --S. 2271: The Renewable Chemicals Act --S. 1656/H.R. 2883: Master Limited Partnership Parity Act --H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act  

Client expense: $2,260,000 · Firm income: Not reported

HR 3539: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015; all provisions of the bill S. 1597: Patient-Focused Impact Assessment Act of 2016; all provisions of the bill S. 1878: Advancing Hope Act of 2016; all provisions of the bill S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016; all provisions of the bill S. 2511: Improving Health Information Technology Act; all provisions of the bill

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

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

Monitor tax issues, including innovation box proposal, international tax reform, and corporate integration; Capital formation tax policy; R&D tax credit; Section 469 R&D Partnership Structures (H.R. 2179, PARTNER Act); Section 382 Net Operating Loss rules; Section 1202 Capital Gains Reforms; Orphan Drug Tax Credit; Support inclusion of vaccines in H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Drug Dependence (general); HIV Screening (general); Gynecologic Cancer (general); Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality and Morbidity (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); Meaningful Use Stage 3; H.R. 3940, Meaningful Use Hardship Relief Act; H.R.4695/S. 466, Quality Care for Moms and Babies Act; H.R. 3865/S.2542, Cradle Act; H.R. 836/S. 884, Health Care Safety Net Enhancement Act; H.R. 865, Good Samaritan Health Professionals Act; H.R. 2603/S. 1475, Saving Lives, Saving Costs Act; H.R. 4774, Training Tomorrows Doctors Today Act; H.R. 3658/S. 84, GEDI Act; H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016; H.R. 1209/S.628 Improving Access to Maternity Care Act; Implementation of H.R. 1462/S. 799, Protecting our Infants Act; H.R. 3691/S. 2226, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 2972, Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act; H.R. 3504/S. 1603, Born-Alive Abortion Survivors Protection Act; H.Res. 461, Establishing a Select Investigative Panel of the Committee on Energy and Commerce; Fetal Tissue Research (General); H.Res. 558/S.Res. 327, Condemning Violence That Targets Healthcare for Women; Senate Biomedical Innovations Packages (general); S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act; S.2742, Promoting Biomedical Research and Public Health for Patients Act; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3652/S. 674, 21st Century Womens Health Act; S. 1532, Affordability is Access Act; H.R. 2191/S. 1170, Breast Cancer Research Stamp Reauthorization Act of 2015; H.R. 1925, To award a Congressional Gold Medal to Dr. Ernie Bodai; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3235/S. 2311, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); and H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act.

.R. 1020 STEM Education Act H.R. 1190/S. 141 Protecting Seniors' Access to Medicare Act H.R. 1314 Bipartisan Budget Act H.R. 160/S. 149 Protect Medical Innovation Act H.R. 1624/S. 1099, Protecting Affordable Coverage for Employees Act (PACE Act) H.R. 2061, Equitable Access to Care and Health (EACH) Act H.R. 2446 To amend title XIX of the Social Security Act to require the use of electronic visit verification for personal care services furnished under the Medicaid program, and for other purposes. H.R. 2603/S. 1475 Saving Lives, Saving Costs Act H.R. 2646 Helping Families in Mental Health Crisis Act H.R. 4212/S.704 Community Based Independence for Seniors Act H.R. 2745/S. 2102 Standard Mergers & Acquisitions Review Through Equal Rules (SMARTER) Act H.R. 2878/S. 1461 To provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015. H.R. 2911/S. 1697 Small Business Healthcare Relief Act H.R. 292/S. 2260 Long-Term Studies of Comprehensive Outcomes and Returns for the Economy Act (Long-Term SCORE Act) H.R. 3081/S. 1778 TELEmedicine for MEDicare (TELE-MED) Act H.R. 3539 Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act H.R. 3660 Preventive Health Savings Act H.R. 3716 Ensuring Terminated Providers are Removed from Medicaid and CHIP Act H.R. 3762 Restoring Americans Healthcare Freedom Reconciliation Act H.R. 4469/S.2499 Health Savings Act of 2016 H.R. 4723 Protecting Taxpayers by Recovering Improper Obamacare Subsidy Overpayments Act H.R. 4725 Common Sense Savings Act H.R. 4732/S.2671 Advancing Medical Resident Training in Community Hospitals Act H.R. 4771 Help Efficient, Accessible, Low-cost, Timely Healthcare Act H.R. 4774 Training Tomorrows Doctors Today Act H.R. 4801 Medical Loss Ratio Accountability Act of 2016 H.R. 4832 Health Savings Protection Act H.R. 4848 Healthy Inpatient Procedures (HIP) Act H.R. 4878 Better Care, Lower Cost Act H.R. 5380 Telehealth Parity Act H.R. 6 21st Century Cures Act H.R.4442/S.2484 CONNECT for Health Act S. 1077 Advancing Breakthrough Medical Devices for Patients Act S. 1101 Medical Electronic Data Technology Enhancement for Consumers Health (MEDTECH) Act S. 139 Ensuring Access to Clinical Trials Act S. 1622 FDA Device Accountability Act S. 1945 Mental Health Reform Act of 2016 S. 2023 Prescription Drug Affordability Act S. 2030 Advancing Targeted Therapies for Rare Diseases Act S. 2045 Middle Class Health Benefits Tax Repeal Act S. 2075 American Worker Health Care Tax Relief Act S. 2153 Provider Payment Sunshine Act S. 2187 FDA Regulatory Efficiency Act S. 2343 Telehealth Innovation and Improvement Act S. 2511 Improving Health Information Technology Act S. 2680 Mental Health Reform Act of 2016 S. 2698 Preserving Consumer Health Accounts Act of 2016 S. 2713 Advancing Precision Medicine Act S. 754 Cybersecurity Information Sharing Act (CISA) S. 1101, the Medical Electronic Data Technology Enhancement for Consumers Health (MEDTECH) Act S. 1077, the Advancing Breakthrough Medical Devices for Patients Act. S. 1622, the FDA Device Accountability Act S. 2511, the Improving Health Information Technology Act S. 2680, the Mental Health Reform Act of 2016 S. 2713, the Advancing Precision Medicine Act

Tax incentives on research into antibiotics, antifungals, and infectious disease diagnostic tests. H.R. 3539.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biosimilars ---Biosimilar User Fee Act Implementation ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming Funding for the National Institutes of Health ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R.2029: Consolidated Appropriations Act for FY 2016 Vaccine Access/Financing ---Vaccine Injury Compensation Program 340B Drug Pricing Program ---Program Implementation & Oversight ---H.R.2029: Consolidated Appropriations Act for FY 2016 Medicaid Pricing and Rebates ---Implementation of Affordable Care Act ---Average Manufacturer Price Calculations Drug Importation ---H.R.2029: Consolidated Appropriations Act for FY 2016 ---Amendment to HR: 3762: The Restoring Americans Healthcare Freedom Reconciliation Act of 2015 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2029: Consolidated Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues TransPacific Partnership ---Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Reimbursement Transparency Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based contracting and communications Drug Evaluation and Review ---Compassionate Use/Expanded Access ---FDA Proposed Rule on Changes to Drug Labeling ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Generic Entry Incentives Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.2029: Consolidated Appropriations Act for FY 2016 Government Price Reporting ---H.R.2029: Consolidated Appropriations Act for FY 2016 Gene Editing Technologies ---H.R. 2029: Consolidated Appropriations Act for 2016 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Precision Medicine Initiative

Renewable Chemicals/Bio-based Products ---S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Biofuels (Non-Funding) ---Accelerated Depreciation Extension ---Production Tax Credit Extension ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---S. 537: COMPETE Act ---S. 341: Start-up Jobs and Innovation Act ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 537: COMPETE Act ---S. 341: Start-up Jobs and Innovation Act ---H.R. 2179: PARTNER Act Tax Reform ---Innovation Box/Patent Box Orphan Drug Act Tax Credit Controlled Foreign Corporation Look-Through Rule Extension ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 Inversions ---H.R.2029: Consolidated Appropriations Act for FY 2016

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

FY2016 Labor-HHS & Ed Appropriations (HR 3020/S1695) FY2016 State-Foreign Operations Appropriations legislation (HR 2772/S1725) H.R. 6, 21st Century Cures Act H.R. 2629, Antibiotic Development to Advance Patient Treatment Act S. 185, PATH ACT antibiotic development H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Drug Dependence (general); HIV Screening (general); Gynecologic Cancer; Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); H.R. 2866, Healthy MOM Act; CMS Health IT Incentive Program, Meaningful Use Stage 3; H.R. 3940, Meaningful Use Hardship Relief Act; S. 466, Quality Care for Moms and Babies Act; S. 1427, Quality Measure Alignment Act of 2015; H.R. 836/S. 884, Health Care Safety Net Enhancement Act; H.R. 865, Good Samaritan Health Professionals Act; H.R. 2603/S. 1475, Saving Lives, Saving Costs Act; H.R. 3658/S. 84, GEDI Act; Pregnancy Discrimination (general); H.R. 2654/S. 1512, Pregnant Workers Fairness Act; H.R. 1209/S.628 Improving Access to Maternity Care Act; H.R. 1462/S.799, Protecting our Infants Act; H.R. 3691/S. 2226, Improving Treatment for Pregnant and Postpartum Women Act; H.R.36/S. 1553, Pain-Capable Unborn Child Protection Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 3134/S. 764, Defund Planned Parenthood Act; H.R. 3504/S. 1603, Born-Alive Abortion Survivors Protection Act; H.R. 3495, Womens Public Health and Safety Act; H.Res. 461, Establishing a Select Investigative Panel of the Committee on Energy and Commerce; H.Res. 558/S.Res. 327, Condemning Violence That Targets Healthcare for Women; H.R. 6, 21st Century Cures Act; Innovation for Healthier Americans; H.R. 1375/S. 142, Child Nicotine Poisoning Prevention Act; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3652/S. 674, 21st Century Womens Health Act; S. 1532, Affordability is Access Act; H.R. 2191/S. 1170, Breast Cancer Research Stamp Reauthorization Act of 2015; H.R. 1925, To award a Congressional Gold Medal to Dr. Ernie Bodai; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3339/S. 1926, Protecting Access to Lifesaving Screenings Act; H.R. 3235, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); and H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act.

H.R. 1190, Protecting Seniors' Access to Medicare Act of 2015 H.R. 1314, the Bipartisan Budget Act of 2015 H.R. 1427/S. 804 Medicare CGM Access Act H.R. 1624/S. 1099, the Protecting Affordable Coverage for Employees Act (PACE Act). H.R. 1686, the Preventing Diabetes in Medicare Act H.R. 1726/S. 1345, the Access to Quality Diabetes Education Act H.R. 2029, Consolidated Appropriations Act, 2016 H.R. 2050/S. 2045, the Middle Class Health Benefits Tax Repeal Act of 2015 H.R. 2061, the Equitable Access to Care and Health (EACH) Act H.R. 209/S. 139, the Ensuring Access to Clinical Trials Act H.R. 2102/S. 1131, the Medicare Diabetes Prevention Act H.R. 2205, the Data Security Act of 2015 H.R. 2404/S.1509, The Treat and Reduce Obesity Act H.R. 2446, To amend title XIX of the Social Security Act to require the use of electronic visit verification for personal care services furnished under the Medicaid program, and for other purposes. H.R. 2646, the Helping Families in Mental Health Crisis Act H.R. 2878/ S. 1461, to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015. H.R. 2911/S. 1697, the Small Business Healthcare Relief Act H.R. 292/S. 2260, the Long-Term Studies of Comprehensive Outcomes and Returns for the Economy Act (Long-Term SCORE Act) H.R. 3081/S.1778 - TELEmedicine for MEDicare (TELE-MED) Act H.R. 3539, the Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act H.R. 3660, the Preventive Health Savings Act H.R. 3716, the Ensuring Terminated Providers are Removed from Medicaid and CHIP Act H.R. 3762, the Restoring Americans Healthcare Freedom Reconciliation Act H.R. 3821, the Medicaid Directory of Caregivers Act H.R. 4155/S. 2343, the Telehealth Innovation and Improvement Act H.R. 4227/S.2392, the Medicare Advantage Bill of Rights Act H.R. 592/S. 314, Pharmacy and Medically Underserved Areas Enhancement Act H.R. 6, 21st Century Cures Act S. 139, Ensuring Access to Clinical Trials Act of 2015 S. 1945, Mental Health Reform Act of 2015 S. 2023, the Prescription Drug Affordability Act S. 2030, the Advancing Targeted Therapies for Rare Diseases Act S. 2104, A bill to amend title XVIII of the Social Security Act to provide relief to Medicare Advantage plans with a significant number of dually eligible or low-income subsidy beneficiaries and to prevent the termination of two star plans. S. 2141, TRUST IT Act S. 2153, the Provider Payment Sunshine Act, S. 2187, the FDA Regulatory Efficiency Act S. 2425, the Patient Access and Medicare Protection Act S. 754, the Cybersecurity Information Sharing Act (CISA)

Tax incentives on research into antibiotics, antifungals, and infectious disease diagnostic tests. H.R. 3539.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY2016 Labor-HHS & Ed Appropriations (HR 3020/S1695) FY2016 State-Foreign Operations Appropriations legislation (HR 2772/S1725) H.R. 6, 21st Century Cures Act H.R. 2629, Antibiotic Development to Advance Patient Treatment Act S. 185, antibiotic development H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Renewable Chemicals/Bio-based Products --Expansion of Master Limited Partnerships to Renewable Chemicals --New Production Tax Credit --S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension --S.2089: American Energy Innovation Act Research & Development Tax Credit Reforms --Extension --Permanency --Refundable R&D Credit --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation Box/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995/S.1910: Department of Financial Services and Related Agencies Appropriations Act for FY 2016 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act

Client expense: $2,100,000 · Firm income: Not reported

Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act

Funding for the Centers for Disease Control and Prevention programs, H.R. 6 - the 21st Century Cures Act and provisions related to antibiotic development and reimbursement, H.R. 2629 - Antibiotic Development to Advance Patient Treatment (ADAPT) Act: Creation of a new regulatory pathway for certain antibiotics, the Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act, H.R. 3539

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Communication with Center for Medicare and medicaid Services regarding Innovation center, direct reimbursement under Medicare Program, annual payment updates, and Part D formulary issues. Support for H.R. 592/S. 314, legislation that would amend title 18 of the Social Security Act to provide for coverage of pharmacist services under the Medicare Program. Signed on to letter in support of H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015. Support for H.R. 6, 21st Century Cures.

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

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), SENATE

Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Drug Dependence (general); HIV Screening (general); Gynecological Cancer; Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); H.R. 2866, Healthy MOM Act; CMS Health IT Incentive Program, Meaningful Use Stage 3; H.R. 1974, HEAL for Immigrant Women and Families Act of 2015; S. 466, Quality Care for Moms and Babies Act; S. 1427, Quality Measure Alignment Act of 2015; H.R. 836/S. 884, Health Care Safety Net Enhancement Act; H.R. 3658/S. 84, GEDI Act; H.R. 2603/S. 1475, Saving Lives, Saving Costs Act; Pregnancy Discrimination (general); S. 821, BPA in Food Packaging Right to Know Act; H.R. 1209/S.628 Improving Access to Maternity Care Act; H.R. 1462/S.799, Protecting our Infants Act; H.R. 6, 21st Century Cures Act; Innovation for Healthier Americans; Health Equity and Accountability Act; H.R. 293 Exempt certain transfers of value from reporting requirements under Sunshine Act; H.R. 1375/S. 142, Child Nicotine Poisoning Prevention Act; H.R. 3652/S. 674, 21st Century Womens Health Act; H.R.7/S. 582, No Taxpayer Funding for Abortion and Abortion Insurance Full Disclosure Act of 2015; H.R.36/S. 1553, Pain-Capable Unborn Child Protection Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 865, Good Samaritan Health Professionals Act of 2015; H.R. 2654/S. 1512, Pregnant Workers Fairness Act; S. 1532, Affordability is Access Act; H.R. 2191/S. 1170, Breast Cancer Research Stamp Reauthorization Act of 2015; H.R. 1925, To award a Congressional Gold Medal to Dr. Ernie Bodai; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3339/S. 1926, Protecting Access to Lifesaving Screenings Act; H.R. 3235, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); H.R. 3134/S. 764, Defund Planned Parenthood Act; H.R. 3504/S. 1603, Born-Alive Abortion Survivors Protection Act; H.R. 3495, Womens Public Health and Safety Act; H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation; H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act; H.R. 2407, School Milk Nutrition Act of 2015.

Rapid Diagnostic Research and Development Tax Credit Act of 2015, H.R.3539

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES