Medical Innovation Act of 2015

National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing; Congressional recognition of World Hemophilia Day and Growth Awareness Week.

Client expense: $590,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act

Client expense: $280,000 · Firm income: Not reported

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

National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing.

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

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

S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research HR639 Improving Regulatory Transparency for New Medical Therapies Act (signed into law) HR 2820 Stem Cell Therapeutic and Research Reauthorization Act of 2015 (signed into law) HR 2646 S1945 Helping Families in Mental Health Crisis Act of 2015 HR 3731, S 2030 Rare Disease Fund Act of 2015 HR 3729 Limit Fetal Tissue Research S 2141 Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015 or TRUST It Act (with respect to health information technology) S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 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 1767 Combination Product Regulatory Fairness Act of 2015 S 1597 Patient-Focused Impact Assessment Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1945 Mental Health Reform Act of 2015 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2700 FDA and NIH Workforce Authorities Modernization Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers)

Client expense: $15,681 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing; Congressional recognition of World Hemophilia Day

Client expense: $690,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of

National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing; Congressional recognition of World Hemophilia Day

Client expense: $970,000 · Firm income: Not reported

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency

Client expense: $290,000 · Firm income: Not reported

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

National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing.

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

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

S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research HR639 Improving Regulatory Transparency for New Medical Therapies Act (signed into law) HR 2820 Stem Cell Therapeutic and Research Reauthorization Act of 2015 (signed into law) HR 2646 S1945 Helping Families in Mental Health Crisis Act of 2015 HR 3731, S 2030 Rare Disease Fund Act of 2015 HR 3729 Limit Fetal Tissue Research S 2141 Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015 or TRUST It Act (with respect to health information technology) S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 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 1767 Combination Product Regulatory Fairness Act of 2015 S 1597 Patient-Focused Impact Assessment Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1945 Mental Health Reform Act of 2015 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2700 FDA and NIH Workforce Authorities Modernization Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers)

Client expense: $36,139 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing; Congressional recognition of World Hemophilia Day

Client expense: $910,000 · Firm income: Not reported

National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1074 and S. 539 National Diabetes Clinical Care Commission Act of 2013; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing.

Client expense: $620,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

Accelerating Biomedical Research Act(S.318/ H.R.744) American Cures Act (S.289) American Tax Payer Relief Act (H.R.8) "fiscal cliff bill"-Medicare/Medicaid Therapy Caps Budget-Provisions Relating to Medicaid and Medicare FY2016 Agriculture Appropriations (S.1800) FY2016 Labor-HHS-Education Appropriations-provisions relating to CDC,HRSA,AHRQ and NIH 2016 Labor HHS - Education Appropriations Research for All Act(H.R.4879) S.2115 American Cures Act H.R.6, 21st Century Cures Act Senate Budget Resolution (S.Con.Res.11)

Client expense: $337,480 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, White House Office

Accelerating Biomedical Research Act(S.318/ H.R.744) American Cures Act (S.289) American Tax Payer Relief Act (H.R.8) "fiscal cliff bill"-Medicare/Medicaid Therapy Caps Budget-Provisions Relating to Medicaid and Medicare FY2016 Agriculture Appropriations FY2016 Labor-HHS-Education Appropriations-provisions relating to CDC,HRSA,AHRQ and NIH FY2015 Omnibus; Consolidated and Further Continuing Appropriations Act(H.R.83) P.L.113-94(H.R.2019) Gabriella Miller Kids First Research Act Research for All Act(H.R.4879) S.2115 American Cures Act Senate Budget Resolution (S.Con.Res.11)

Client expense: $210,171 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, White House Office

Fertility and multiple sclerosis treatments. H.R. 1735, National Defense Authorization Act for Fiscal Year 2016. S. 1356, National Defense Authorization Act for Fiscal Year 2016. H.R. 744/S. 320, Medical Innovation Act of 2015.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues

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

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

S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research HR639 Improving Regulatory Transparency for New Medical Therapies Act (signed into law) HR 2820 Stem Cell Therapeutic and Research Reauthorization Act of 2015 (signed into law) HR 2646 S1945 Helping Families in Mental Health Crisis Act of 2015 HR 3731 Rare Disease Fund Act of 2015 (Andrew Los brainchild) HR 3729 Limit Fetal Tissue Research S 2141 Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015 or TRUST It Act (with respect to health information technology)

Client expense: $58,549 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ), NIH Presidents Budget, FY 2016 H.R. 3020/S. 1695, Labor, HHS, Education and Related Agencies Act, 2016, Title II P.L. 114-113, H.R. 2029, Consolidated Appropriations Act, 2016, Division H, Title II Issues: Support funding for National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), biodefense and public health preparedness programs, Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2017 H.R. 2029 and draft Senate Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2016 P.L. 114-113, Consolidated Appropriations Act, 2016, Division J, Title II Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Support the use of animals in medical research. Issue: Oppose discretionary spending cuts through sequestration, including NIH and other science programs. Issue: Funding for pandemic preparedness and biodefense programs Issue: Draft legislation on protections for human subjects in research S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) Issue: Support federal funding for research using human fetal tissue. H.R. 3466/S. 2014, Next Generation Research Act Issue: Support National Institutes of Health programs for new and young scientists. H.R. 3119, draft Senate legislation, Palliative Care and Hospice Education and Training Act Issue: Health professions education on palliative care Submitted comments to: -HRSA on Proposed Omnibus Guidance on 340B Drug Pricing Program -FDA on International Scheduling of Ketamine -NIH on its strategic plan to advance research on the health and well-being of sexual and gender minorities

Client expense: $780,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ), NIH Presidents Budget, FY 2016 H.R. 3020/S. 1695, Labor, HHS, Education and Related Agencies Act, 2016, Title II P.L. 114-113, H.R. 2029, Consolidated Appropriations Act, 2016, Division H, Title II Issues: Support funding for National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), biodefense and public health preparedness programs. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2017 H.R. 2029 and draft Senate Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2016 P.L. 114-113, Consolidated Appropriations Act, 2016, Division J, Title II Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Oppose discretionary spending cuts through sequestration, including NIH and other science programs. Issue: Supporting the use of animals in medical research. Issue: Funding for pandemic preparedness and biodefense programs. Issue: Draft legislation on protections for human subjects in research. S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health (NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) H.R. 3466/S. 2014, Next Generation Research Act Issue: Support National Institutes of Health programs for new and young scientists. H.R. 1806, The America COMPETES Act of 2015 Issue: Support increased funding for the National Science Foundation (NSF) Issue: Support federal funding for research using human fetal tissue. Submitted comments to: -FDA on International Scheduling of Ketamine -NIH on strategies to enhance diversity in the physician�scientist workforce -NIH on its strategic plan to advance research on the health and well-being of sexual and gender minorities

Client expense: $780,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ), Hospital Preparedness Program, NIH, Title VII & VIII Presidents Budget, FY 2016 H.R. 3020/S. 1695, Labor, HHS, Education and Related Agencies Act, 2016, Title II P.L. 114-113, H.R. 2029, Consolidated Appropriations Act, 2016, Division H, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), biodefense and public health preparedness programs,. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2017 H.R. 2029 and draft Senate Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2016 P.L. 114-113, Consolidated Appropriations Act, 2016, Division J, Title II Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Support mandatory funding for Community Health Centers and the National Health Service Corps (NHSC) authorized under P.L. 111-148, the Patient Protection and Affordable Care Act, Title V and Section 10503. Draft Debt in Health Education Loan Programs (DebtHELP) legislative proposal Issues: Expand National Health Service Corps State Loan Repayment program, and align Department of Education and HRSA student loan programs. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act of 2015 Issues: Support lifting cap on number of residents Medicare will count when determining teaching hospitals' Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments Issues: Support lifting cap on number of residents Medicare will count when determining teaching hospitals' Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments and increase Graduate Medical Education (GME) accountability and transparency. Issue: Funding and reporting requirements for Teaching Health Center Graduate Medical Education program under section 340G of the Public Health Service Act. H.R. 3288, Strengthening DSH and Medicare through Subsidy Recapture and Payment Reform Act of 2015 Issue: Alter DSH payment methodology and increase DSH spending in non-Medicaid expansion states H.R. 3292, Medicare IME Pool Act of 2015 Issue: Oppose redesign of Medicare Indirect Medical Education financing and redistribution. H.R. 3291, Medicare Crosswalk Hospital Code Development Act of 2015 Issue: Create a crosswalk between Medicare Part A and Part B payments P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015. Issues: Support repeal of Medicare's sustainable growth rate (SGR) formula; Medicare physician payment reform; extension of the Childrens Health Insurance Program (CHIP); and extension of mandatory funding for the National Health Service Corps (NHSC). Issue: Support the use of animals in medical research. Issue: Promote interprofessional education and training of the health care workforce. Issue: Support funding for the National Healthcare Workforce Commission. Issue: Oppose reduction in Medicare hospital outpatient department reimbursement. P.L. 114-74, H.R. 1314, Bipartisan Budget Act of 2015 Issue: Oppose Medicare site-neutral payment policy. Oppose extension of Medicare sequester S. 2107/H.R. 1006, Building A Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development. Issue: Oppose inclusion of Medicare add-on payments in Hospital-Acquired Condition (HAC) program. Issue: Support delay of enforcement of new CMS inpatient criteria (e.g., "Two-Midnight" rule) in FY 2016 Inpatient Prospective Payment System (IPPS) final rule. Issue: Support Medicare GME per Resident Amount and cap trigger technical corrections and administrative relief. H.R. 1343, Establishing Beneficiary Equity in the Hospital Readmissions Program Act of 2015. S. 688, Hospital Readmission Accuracy and Accountability Act. Issue: Support inclusion of socioeconomic status as part of hospital readmissions program, including support for adoption of National Quality Forum (NQF) recommendations. President's Budget, FY 2016 Issues: Oppose proposed reductions in Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments; oppose use of Medicare GME funding for creation of new GME grant program; oppose elimination of Children's Hospitals GME program. Issue: Legislation on educating health professionals regarding appropriate use of antibiotics, prescription drug abuse, pain management, female genital mutilation, and sepsis. Issue: Implementation of the 340B drug pricing program. Oppose efforts to restrict the program. Issue: Oppose Medicare payment reductions as offsets for non-Medicare spending. Issue: Oppose extension of Medicare sequester Issue: Oppose Medicare hospital cuts as offsets for physician payment reform. Issue: Preserve funding for the Primary Care Residency Expansion program. P.L. 114-41, Surface Transportation and Veterans Health Care Choice Improvement Act of 2015 Issue: Support improved contracting with academic affiliates and increased VA GME funding. H.R.1272, Doctors Helping Heroes Act of 2015 Issue: Support expansion of the Conrad 30 J-1 visa waiver program and physician immigration to address VA workforce shortages S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) Draft Community Based Medical Education Act of 2014 Issue: Oppose reduction of Medicare GME/IME payments S. 1455, Recovery Enhancement for Addiction Treatment (TREAT) Act Issue: Support legislation to increase access to care for patients addicted to opioids Draft Hospital Improvements for Payment (HIP) Act of 2014 Issues: Support repeal of CMS Two-Midnights Rule, extending RAC audit moratorium for short stays, and permanent bundle program. Issue: Oppose further delays in the implementation of the ICD-10 system H.R. 1411, Expanding Nutrition's Role in Curricula and Healthcare Act (ENRICH Act) Issue: Support grants for medical schools to develop or expand nutrition and physical activity curricula. Issue: Funding for Ebola Treatment Centers and hospital preparedness Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. H.R. 2513, Promoting Access, Competition, and Equity Act of 2015 Issue: Oppose easing restrictions on physician owned hospitals Issue: Senate Finance Committee Chronic Care Workgroup, support and send comments on efforts to improve care for Medicare patients with chronic conditions. H.R. 3285, Reducing Disparities Using Care Models and Education Act of 2015 Issue: Studying and developing guidelines to reduce health disparities Draft Health Equity and Accountability Act Issue: Addressing health equity through health care workforce programs Issue: Support federal funding for research using human fetal tissue. H.R. 3119, draft Senate legislation, Palliative Care and Hospice Education and Training Act Issue: Health professions education on palliative care Submitted comments to: -HRSA on Proposed Omnibus Guidance on 340B Drug Pricing Program -FDA on International Scheduling of Ketamine -CMS on implementation of the Medicare Access and CHIP Reauthorization Act of 2015 -NIH on its strategic plan to advance research on the health and well-being of sexual and gender minorities -HHS on nondiscrimination in heath programs and activities

Client expense: $780,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing.

Client expense: Not reported · Firm income: Not reported

National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; H.R. 1192 and S. 586 National Diabetes Clinical Care Commission Act of 2015; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing.

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

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

H.R.1735, National Defense Authorization Act for Fiscal Year 2016. Fertility and multiple sclerosis treatments. H.R.744/S. 320, Medical Innovation Act of 2015.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B Issues and Legislative Reform Proposals Drug Shortage Issues Health Technology Assessment of Orphan Drugs Sequestration of FDA User Fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures Initiative including H.R.6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases. Implementation of Orphan Drug Act and Orphan Drug Development S. 122, Safe and Affordable Drugs from Canada Act of 2015 S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of Newborn Screening Programs Biosimilars Exclusivity Period Biosimilars FDA Guidance FDA Oversight and Management Expanded Access Programs Patient Involvement with FDA Decision Making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023,Prescription Drug Affordability Act of 2015

Client expense: $235,000 · Firm income: Not reported

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

Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ), Hospital Preparedness Program, NIH, Title VII & VIII Presidents Budget, FY 2016 H.R. 3020/S. 1695, Labor, HHS, Education and Related Agencies Act, 2016, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), biodefense and public health preparedness programs,. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2016 H.R. 4486 and draft Senate House Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015 Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Support Obama Administrations position on King v Burwell Issue: Support mandatory funding for Community Health Centers and the National Health Service Corps (NHSC) authorized under P.L. 111-148, the Patient Protection and Affordable Care Act, Title V and Section 10503. Draft Debt in Health Education Loan Programs (DebtHELP) legislative proposal Issues: Expand National Health Service Corps State Loan Repayment program, and align Department of Education and HRSA student loan programs. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act of 2015 Issues: Support lifting cap on number of residents Medicare will count when determining teaching hospitals' Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments Issues: Support lifting cap on number of residents Medicare will count when determining teaching hospitals' Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments and increase Graduate Medical Education (GME) accountability and transparency. Issue: Funding and reporting requirements for Teaching Health Center Graduate Medical Education program under section 340G of the Public Health Service Act. H.R. 3288, Strengthening DSH and Medicare through Subsidy Recapture and Payment Reform Act of 2015 Issue: Alter DSH payment methodology and increase DSH spending in non-Medicaid expansion states H.R. 3292, Medicare IME Pool Act of 2015 Issue: Oppose redesign of Medicare Indirect Medical Education financing and redistribution. H.R. 3291, Medicare Crosswalk Hospital Code Development Act of 2015 Issue: Create a crosswalk between Medicare Part A and Part B payments P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015. Issues: Support repeal of Medicare's sustainable growth rate (SGR) formula; Medicare physician payment reform; extension of the Childrens Health Insurance Program (CHIP); and extension of mandatory funding for the National Health Service Corps (NHSC). Issue: Support the use of animals in medical research. Issue: Promote interprofessional education and training of the health care workforce. Issue: Support funding for the National Healthcare Workforce Commission. Issue: Oppose reduction in Medicare hospital outpatient department reimbursement. S. 2107/H.R. 1006, Building A Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development. Issue: Oppose inclusion of Medicare add-on payments in Hospital-Acquired Condition (HAC) program. Issue: Support delay of enforcement of new CMS inpatient criteria (e.g., "Two-Midnight" rule) in FY 2016 Inpatient Prospective Payment System (IPPS) final rule. Issue: Support Medicare GME per Resident Amount and cap trigger technical corrections and administrative relief. H.R. 1343, Establishing Beneficiary Equity in the Hospital Readmissions Program Act of 2015. S. 688, Hospital Readmission Accuracy and Accountability Act. Issue: Support inclusion of socioeconomic status as part of hospital readmissions program, including support for adoption of National Quality Forum (NQF) recommendations. President's Budget, FY 2016 Issues: Oppose proposed reductions in Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments; oppose use of Medicare GME funding for creation of new GME grant program; oppose elimination of Children's Hospitals GME program. Issue: Legislation on educating health professionals regarding appropriate use of antibiotics, prescription drug abuse, pain management, female genital mutilation, and sepsis. Issue: Implementation of the 340B drug pricing program. Oppose efforts to restrict the program. Issue: Oppose Medicare payment reductions as offsets for non-Medicare spending. Issue: Oppose Medicare hospital cuts as offsets for physician payment reform. Issue: Preserve funding for the Primary Care Residency Expansion program. P.L. 114-41, Surface Transportation and Veterans Health Care Choice Improvement Act of 2015 Issue: Support improved contracting with academic affiliates and increased VA GME funding. H.R.1272, Doctors Helping Heroes Act of 2015 Issue: Support expansion of the Conrad 30 J-1 visa waiver program and physician immigration to address VA workforce shortages S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) Draft Community Based Medical Education Act of 2014 Issue: Oppose reduction of Medicare GME/IME payments S. 1455, Recovery Enhancement for Addiction Treatment (TREAT) Act Issue: Support legislation to increase access to care for patients addicted to opioids Draft Hospital Improvements for Payment (HIP) Act of 2014 Issues: Support repeal of CMS Two-Midnights Rule, extending RAC audit moratorium for short stays, and permanent bundle program. Issue: Oppose further delays in the implementation of the ICD-10 system H.R. 1411, Expanding Nutrition's Role in Curricula and Healthcare Act (ENRICH Act) Issue: Support grants for medical schools to develop or expand nutrition and physical activity curricula. Issue: Funding for Ebola Treatment Centers and hospital preparedness Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. H.R. 2513, Promoting Access, Competition, and Equity Act of 2015 Issue: Oppose easing restrictions on physician owned hospitals Issue: Senate Finance Committee Chronic Care Workgroup, support and send comments on efforts to improve care for Medicare patients with chronic conditions. H.R. 3285, Reducing Disparities Using Care Models and Education Act of 2015 Issue: Studying and developing guidelines to reduce health disparities Draft Health Equity and Accountability Act Issue: Addressing health equity through health care workforce programs Issue: Support federal funding for research using human fetal tissue. Submitted comments to: Department of Veterans Affairs on VA health care contracting and potential risks to VA-academic affiliations Centers for Medicare & Medicaid Services (CMS) on CY 2016 Physician Fee Schedule proposed rule CMS on the on the Comprehensive Care for Joint Replacement (CCJR) proposed rule CMS on CY 2016 Outpatient Prospective Payment System (OPPS) proposed rule CMS on the methodology of overall Hospital Quality Star Ratings technical expert panel report CMS on the Medicaid and CHIP Managed Care proposed rule

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ), NIH Presidents Budget, FY 2016 H.R. 3020/S. 1695, House Labor, HHS, Education and Related Agencies Act, 2016, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), biodefense and public health preparedness programs, Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2016 H.R. 4486 and draft Senate House Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015 Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Support the use of animals in medical research. Issue: Oppose discretionary spending cuts through sequestration, including NIH and other science programs. Issue: Funding for pandemic preparedness and biodefense programs Issue: Draft legislation on protections for human subjects in research S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) Issue: Support federal funding for research using human fetal tissue. H.R. 3466/S. 2014, Next Generation Research Act Issue: Support National Institutes of Health programs for new and young scientists. Submitted comments to: National Institute on Minority Health and Health Disparities (NIMHD) on interdisciplinary training in health disparities science The White House on the Precision Medicine Initiatives proposed privacy and trust principles National Institutes of Health (NIH) on the framework for the NIH-wide Strategic Plan NIMHD on the NIH Science Vision for health disparities research

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ), NIH Presidents Budget, FY 2016 H.R. 3020/S. 1695, House Labor, HHS, Education and Related Agencies Act, 2016, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), biodefense and public health preparedness programs. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2016 H.R. 4486 and draft Senate House Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015 Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Oppose discretionary spending cuts through sequestration, including NIH and other science programs. Issue: Supporting the use of animals in medical research. Issue: Funding for pandemic preparedness and biodefense programs. Issue: Draft legislation on protections for human subjects in research. S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health (NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) H.R. 3466/S. 2014, Next Generation Research Act Issue: Support National Institutes of Health programs for new and young scientists. H.R. 1806, The America COMPETES Act of 2015 Issue: Support increased funding for the National Science Foundation (NSF) Issue: Support federal funding for research using human fetal tissue. Submitted comments to: National Institute on Minority Health and Health Disparities (NIMHD) on interdisciplinary training in health disparities science The White House on the Precision Medicine Initiatives proposed privacy and trust principles National Institutes of Health (NIH) on the framework for the NIH-wide Strategic Plan NIMHD on the NIH Science Vision for health disparities research

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research

Client expense: $58,549 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

National Diabetes Prevention Program; Better care and treatment of people with diabetes under P.L. 111-148 Patient Protection and Affordable Care Act of 2009 (ACA) and P.L. 111-152 The Health Care & Education Affordability Reconciliation Act of 2010: Issues related to diabetes generally, and specifically diabetes screening, medical education and death certificate reporting (Catalyst for Better Diabetes), AHRQ and USPSTF diabetes screening standards; diabetes issues in Healthy People 2020 and the Office of Disease Prevention and Health Promotion (ODPHP); H.R. 1074 and S. 539 National Diabetes Clinical Care Commission Act of 2013; P.L. 114-10, Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) for Special Diabetes Program, CHIP, and childhood obesity; S. 84 and H.R. 3658 Gestational Diabetes Act of 2015; H.R. 1190 and S. 141 Protecting Seniors' Access to Medicare Act of 2015 (IPAB repeal); H.R. 2651 Eliminating Disparities in Diabetes Prevention, Access, and Care Act of 2015 (EDDPAC); cost of diabetes generally; S. 320 and H.R. 744 Medical Innovation Act of 2015; S. 2023 and H.R. 3513 Prescription Drug Affordability Act of 2015; H.R. 3742, Access to Marketplace Insurance Act and general allowance for certain third party payments of cost sharing.

Client expense: $620,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

Accelerating Biomedical Research Act(S.318/ H.R.744) American Cures Act (S.289) American Tax Payer Relief Act (H.R.8) "fiscal cliff bill"-Medicare/Medicaid Therapy Caps Budget-Provisions Relating to Medicaid and Medicare FY2016 Agriculture Appropriations (S.1800) FY2016 Labor-HHS-Education Appropriations-provisions relating to CDC,HRSA,AHRQ and NIH 2016 Labor HHS - Education Appropriations Research for All Act(H.R.4879) S.2115 American Cures Act H.R.6, 21st Century Cures Act Senate Budget Resolution (S.Con.Res.11)

Client expense: Not reported · Firm income: $337,480

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, White House Office

H.R.1735, National Defense Authorization Act for Fiscal Year 2016. Fertility and multiple sclerosis treatments. H.R.744/S. 320, Medical Innovation Act of 2015.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B Issues and Legislative Reform Proposals Drug Shortage Issues Health Technology Assessment of Orphan Drugs Sequestration of FDA User Fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures Initiative including H.R.6, 21st Century Cures Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases. Implementation of Orphan Drug Act and Orphan Drug Development S. 122, Safe and Affordable Drugs from Canada Act of 2015 S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531, Advancing Hope Act of 2015 Implementation of Newborn Screening Programs Biosimilars Exclusivity Period Biosimilars FDA Guidance FDA Oversight and Management Expanded Access Programs Patient Involvement with FDA Decision Making S. 289 and H.R. 2104, American Cures Act

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

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

1) Support 340B anti-fraud and program integrity policies; 2) Support policies to improve National Newborn Screening Program, including H.R. 1281 and S. 1417; 3) ACA implementation oversight to protect patient access to medical specialists in new health care insurance exchanges; 4) support efforts to modernize FDA processes in the 21st Century Cures initiative; and 5) Opposition to the Medical Innovation Act (S. 320/H.R. 744).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ) Presidents Budget, FY 2016 S. 1695 and draft House Labor, HHS, Education and Related Agencies Act, 2016, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), biodefense and public health preparedness programs, and CDC's National Healthcare Safety Network (NHSN) and the Prevention Epicenters Program. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2016 H.R. 4486 and draft Senate House Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015 Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Support the use of animals in medical research. Issue: Oppose discretionary spending cuts through sequestration, including NIH and other science programs. Issue: Funding for pandemic preparedness and biodefense programs Issue: Draft legislation on protections for human subjects in research S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) Draft Next Generation Research Act Issue: Support National Institutes of Health programs for new and young scientists. Submitted comments to: NIH on precision medicine and community engagement NIH on policies and strategies to improve the sustainability of biomedical research HHS Office for Human Research Protections (OHRP) on draft guidance for electronic informed consent in clinical investigations FDA on draft guidance for electronic informed consent in clinical investigations

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ) Presidents Budget, FY 2016 S. 1695 and draft House Labor, HHS, Education and Related Agencies Act, 2016, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), biodefense and public health preparedness programs, and CDC's National Healthcare Safety Network (NHSN) and the Prevention Epicenters Program. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2016 H.R. 4486 and draft Senate House Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015 Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Oppose discretionary spending cuts through sequestration, including NIH and other science programs. Issue: Supporting the use of animals in medical research. Issue: Funding for pandemic preparedness and biodefense programs. Issue: Draft legislation on protections for human subjects in research. S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health (NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) Draft Next Generation Research Act Issue: Support National Institutes of Health programs for new and young scientists. H.R. 1806, The America COMPETES Act of 2015 Issue: Support increased funding for the National Science Foundation (NSF) Submitted comments to: NIH on precision medicine and community engagement NIH on policies and strategies to improve the sustainability of biomedical research HHS Office for Human Research Protections (OHRP) on draft guidance for electronic informed consent in clinical investigations FDA on draft guidance for electronic informed consent in clinical investigations

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

Presidents Budget, FY 2017 Issue: Funding for Agency for Healthcare Research and Quality (AHRQ) Presidents Budget, FY 2016 S. 1695 and draft House Labor, HHS, Education and Related Agencies Act, 2016, Title II Issues: Support funding for National Institutes of Health (NIH), Title VII and Title VIII health professions and nursing education programs, Agency for Healthcare Research and Quality (AHRQ), National Health Service Corps (NHSC), Childrens Hospitals Graduate Medical Education (CHGME), Health Resources and Services Administration (HRSA), the Prevention and Public Health Fund (PPHF), biodefense and public health preparedness programs, and CDC's National Healthcare Safety Network (NHSN) and the Prevention Epicenters Program. Maintain NIH salary cap at Executive Level II. Encourage the highest possible allocation for the Labor-HHS Subcommittee. Oppose House proposal to eliminate AHRQ. Oppose rescissions from CMMI and PCORI. President's Budget, FY 2016 H.R. 4486 and draft Senate House Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015 Issues: Support funding for Veterans Affairs medical research, research infrastructure, and health care. Issue: Support Obama Administrations position on King v Burwell Issue: Support mandatory funding for Community Health Centers and the National Health Service Corps (NHSC) authorized under P.L. 111-148, the Patient Protection and Affordable Care Act, Title V and Section 10503. Draft Debt in Health Education Loan Programs (DebtHELP) legislative proposal Issues: Expand National Health Service Corps State Loan Repayment program, and align Department of Education and HRSA student loan programs. H.R. 2124/S. 1148, Resident Physician Shortage Reduction Act of 2015 Issues: Support lifting cap on number of residents Medicare will count when determining teaching hospitals' Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments Issues: Support lifting cap on number of residents Medicare will count when determining teaching hospitals' Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments and increase Graduate Medical Education (GME) accountability and transparency. Issue: Funding and reporting requirements for Teaching Health Center Graduate Medical Education program under section 340G of the Public Health Service Act. H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015. H.R. 810/S. 1871, SGR Repeal and Medicare Beneficiary Access Improvement Act of 2015. Issues: Support repeal of Medicare's sustainable growth rate (SGR) formula; Medicare physician payment reform; extension of the Childrens Health Insurance Program (CHIP); and extension of mandatory funding for the National Health Service Corps (NHSC). Issue: Support the use of animals in medical research. Issue: Promote interprofessional education and training of the health care workforce. Issue: Support funding for the National Healthcare Workforce Commission. Issue: Oppose reduction in Medicare hospital outpatient department reimbursement. H.R. 1006, Building A Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development. Issue: Oppose inclusion of Medicare add-on payments in Hospital-Acquired Condition (HAC) program. Issue: Support delay of enforcement of new CMS inpatient criteria (e.g., "Two-Midnight" rule) in FY 2014 Inpatient Prospective Payment System (IPPS) final rule. Issue: Support Medicare GME per Resident Amount and cap trigger technical corrections and administrative relief. H.R. 1343, Establishing Beneficiary Equity in the Hospital Readmissions Program Act of 2015. S. 688, Hospital Readmission Accuracy and Accountability Act. Issue: Support inclusion of socioeconomic status as part of hospital readmissions program, including support for adoption of National Quality Forum (NQF) recommendations. President's Budget, FY 2016 Issues: Oppose proposed reductions in Medicare Direct Graduate Medical Education (DGME) and Indirect Medical Education (IME) payments; oppose use of Medicare GME funding for creation of new GME grant program; oppose elimination of Children's Hospitals GME program. Issue: Legislation on educating health professionals regarding appropriate use of antibiotics. Issue: Implementation of the 340B drug pricing program. Oppose efforts to restrict the program. Issue: Oppose Medicare payment reductions as offsets for non-Medicare spending. Issue: Oppose Medicare hospital cuts as offsets for physician payment reform. Issue: Preserve funding for the Primary Care Residency Expansion program. P.L. 113-564, Veterans Access, Choice, and Accountability Act of 2014 Issues: Support improved contracting with academic affiliates and increased VA GME funding. H.R.1272, Doctors Helping Heroes Act of 2015 Issue: Support expansion of the Conrad 30 J-1 visa waiver program and physician immigration to address VA workforce shortages S. 289/H.R. 2104, American Cures Act Issue: Increases budget authority for National Institutes of Health NIH), Center for Disease Control and Prevention, Department of Defense Health Program, and the VA Medical and Prosthetics Research Program S. 320/H.R. 744, Medical Innovation Act Issue: Requires covered manufacturers of blockbuster drugs developed, in whole or in part, through federal investments in medical research that enter settlement agreements with a federal agency to pay 1 percent of net income over five years to increase congressional investments in biomedical research. S. 318/H.R. 531, Accelerating Biomedical Research Act Issue: Increases discretionary spending cap to increase funding for the National Institutes of Health (NIH). H.R. 777, Permanent Investment in Health Research Act Issue: Creates mandatory appropriation for the National Institutes of Health (NIH), adjusted annually for inflation. H.R. 6, 21st Century Cures Act Senate HELP Committee Innovation Initiative Issue: Support increased funding for medical research, reduce administrative and regulatory burden on scientists and research institutions, and support young investigators. H.R. 2102, Research for All Act of 2015 Issue: Support inclusion of male and female cells and animals in basic research, and NIH updating its guidelines on inclusion of women in clinical research. Issue: FDA regulation of Laboratory Developed Tests (LDTs) Draft Community Based Medical Education Act of 2014 Issue: Oppose reduction of Medicare GME/IME payments S. 1455, Recovery Enhancement for Addiction Treatment (TREAT) Act Issue: Support legislation to increase access to care for patients addicted to opioids Draft Hospital Improvements for Payment (HIP) Act of 2014 Issues: Support repeal of CMS Two-Midnights Rule, extending RAC audit moratorium for short stays, and permanent bundle program. Issue: Oppose further delays in the implementation of the ICD-10 system H.R. 1411, Expanding Nutrition's Role in Curricula and Healthcare Act (ENRICH Act) Issue: Support grants for medical schools to develop or expand nutrition and physical activity curricula. Issue: Funding for Ebola Treatment Centers and hospital preparedness Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. H.R. 2513, Promoting Access, Competition, and Equity Act of 2015 Issue: Oppose easing restrictions on physician owned hospitals Issue: Senate Finance Committee Chronic Care Workgroup, support and send comments on efforts to improve care for Medicare patients with chronic conditions. Submitted comments to: CMS on the FY 2016 Inpatient Prospective Payment System (IPPS) proposed rule CMS on the modifications on meaningful use 2015-2017 proposed rule HHS on the CMS short-stay inpatient admission policy, the Two Midnights rule The Office of the National Coordinator for Health Information Technology (ONC) on the 2015 Edition Health Information Technology Certification Criteria proposed rule CMS on the Meaningful Use Stage 3 proposed rule FDA on public health concerns of demographic subgroups The White House on AAMCs commitment to the effective use and management of antibiotic treatment

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of the Census, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), White House Office

Education and awareness of the 2014-2015 influenza season; education and awareness of Avian influenza; education and awareness of pandemic and biodefense funding; education and awareness of Dengue; general issues related to FDA and NIH funding; all provisions of S320 and HR744 "Medical Innovation Act"; the importance of immunizations for herd immunity; all issues related to the 21st Century Cures Initiative including all provisions of HR6 "To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes (21st Century Cures Act)"; general issues related to the importation of pharmaceutical products, including all provisions of S122 "Safe and Affordable Drugs from Canada Act of 2015; all provisions of Preserving Access to Orphan Drugs Act (discussion draft); The President's Budget Proposal - the proposal related to reducing from 12 years to 7 years the data exclusivity period for innovator biologics and the proposal related to generating additional savings from the Independent Payment Advisory Board (IPAB); education and awareness of diabetes and related treatments; issues related to the need for research into clinical tools to diagnose and assess the severity of atopic dermatitis; and education and awareness of cardiovascular disease and related treatments.

Client expense: $840,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax)

Client expense: $29,766 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 153 I-Squared Act of 2015 S 341 Start-up Jobs and Innovation Act HR 962 Startup Act HR 213 Fairness for High-Skilled Immigrants Act of 2015 Health (Bill) S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax)

Client expense: $29,766 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Education and awareness of the 2014-2015 influenza season; education and awareness of Avian influenza; education and awareness of pandemic and biodefense funding; education and awareness of Dengue; general issues related to FDA and NIH funding; all provisions of S320 and HR744 "Medical Innovation Act"; the importance of immunizations for herd immunity; all issues related to the 21st Century Cures Initiative including all provisions of HR6 "To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes (21st Century Cures Act)"; general issues related to the importation of pharmaceutical products, including all provisions of S122 "Safe and Affordable Drugs from Canada Act of 2015; all provisions of Preserving Access to Orphan Drugs Act (discussion draft); The President's Budget Proposal - the proposal related to reducing from 12 years to 7 years the data exclusivity period for innovator biologics and the proposal related to generating additional savings from the Independent Payment Advisory Board (IPAB); education and awareness of diabetes and related treatments; issues related to the need for research into clinical tools to diagnose and assess the severity of atopic dermatitis; and education and awareness of cardiovascular disease and related treatments.

Client expense: $510,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Education and awareness of the need for immunizations, pandemic/biodefense funding; The Medical Innovation Act (S. 320/H.R. 744); the 21st Century Cures Initiative (HR 6); the Safe and Affordable Drugs from Canada Act (S. 122) or possible amendments to legislation affecting the importation of prescription drugs; and education/awareness of diabetes and its treatment. Adequacy of funding for the FDA and NIH. Possible changes to the 340B drug pricing program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Accelerating Biomedical Research Act(S.318/ H.R.744) American Cures Act (S.289) American Tax Payer Relief Act (H.R.8) "fiscal cliff bill"-Medicare/Medicaid Therapy Caps Budget-Provisions Relating to Medicaid and Medicare FY2016 Agriculture Appropriations FY2016 Labor-HHS-Education Appropriations-provisions relating to CDC,HRSA,AHRQ and NIH FY2015 Omnibus; Consolidated and Further Continuing Appropriations Act(H.R.83) P.L.113-94(H.R.2019) Gabriella Miller Kids First Research Act Research for All Act(H.R.4879) S.2115 American Cures Act Senate Budget Resolution (S.Con.Res.11)

Client expense: Not reported · Firm income: $210,171

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, White House Office

H.R. xxxx/S. xxxx - the FY 16 Labor-HHS-Education Appropriations Act - issues around funding for biomedical research, particularly at NIH, also AHRQ H.R. xxxx, the 21st Century Cures Act - provisions related to drug development, clinical trials and clinical and translational research H.R. xxx, the Clinical Research Modernization Act - provisions related to institutional review boards (IRBs) S.185, the PATH Act - provisions related to development of new antimicrobial drugs General issues around alternative funding legislation for NIH including S. 289 the American Cures Act; H.R. 531/S. 318, the Accelerating Biomedical Research Act; and H.R. 744/S. 320, the Medical Innovation Act Issues related to biomedical research funding, particularly at NIH and AHRQ Issues related to the HELP Committees Healthier America Initiative and innovation agenda Issues related to funding for the hospital preparedness program

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act 21st Century Cures (House discussion draft) from Energy and Commerce Committee S 289 American Cures Act

Client expense: $56,235 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. xxxx/S. xxxx - the FY 16 Labor-HHS-Education Appropriations Act - issues around funding for biomedical research, particularly at NIH, also AHRQ H.R. xxxx, the 21st Century Cures Act - provisions related to drug development, clinical trials and clinical and translational research H.R. xxx, the Clinical Research Modernization Act - provisions related to institutional review boards (IRBs) S.185, the PATH Act - provisions related to development of new antimicrobial drugs General issues around alternative funding legislation for NIH including S. 289 the American Cures Act; H.R. 531/S. 318, the Accelerating Biomedical Research Act; and H.R. 744/S. 320, the Medical Innovation Act Issues related to biomedical research funding, particularly at NIH and AHRQ Issues related to the HELP Committees Healthier America Initiative and innovation agenda Issues related to funding for the hospital preparedness program

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B Issues Drug Shortage Issues Health Technology Assessment of Orphan Drugs Sequestration of FDA User Fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures Initiative H.R. 909, Andrea Sloan CURE Act H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases. Implementation of Orphan Drug Act and Orphan Drug Development S. 122, Safe and Affordable Drugs from Canada Act of 2015 S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531, Advancing Hope Act of 2015 Implementation of Newborn Screening Programs Biosimilars Exclusivity Period Biosimilars FDA Guidance FDA Oversight and Management Expanded Access Programs Patient Involvement with FDA Decision Making H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015

Client expense: $270,000 · Firm income: Not reported

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