Medical Device Access and Innovation Protection Act

Implementation of PL 114-255: 21st Century Cures Act Implementation of PL-111-148: PPACA S. 149, Medical Device Access & Innovation Protection Act Policies promoting medical innovation Heart Valve Disease Awareness H.R. 2430: FDA Reauthorization Act of 2017 S. 934: FDA Reauthorization of 2017 H.R. 184, Protect Medical Innovation Act of 2017 Post-market Surveillance H.R. 2430: FDA Reauthorization Act of 2017 H.R. 2144: Risk-Based Classification of Accessories Act of 2017 H.R.1736: To amend the Federal Food, Drug, and Cosmetic Act S. 404: A bill to amend the Federal Food, Drug, and Cosmetic Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. H.R. 160, Protect Medical Innovation Act of 2015. S. 149, Medical Device Access and Innovation Protection Act. S. 440, Veterinary Medicine Loan Repayment Program Enhancement Act.

Client expense: $1,880,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. H.R. 160, Protect Medical Innovation Act of 2015. S. 149, Medical Device Access and Innovation Protection Act. S. 440, Veterinary Medicine Loan Repayment Program Enhancement Act.

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

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Monitor legislative and federal activity related to tax reform. H.R. 160, Protect Medical Innovation Act of 2015. S. 149, Medical Device Access and Innovation Protection Act. S. 440, Veterinary Medicine Loan Repayment Program Enhancement Act.

Client expense: $2,130,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

International Tax Policy Corporate Tax Reform Medical Device Tax Repeal Research and Development Tax Policy Patent/Innovation Box Tax Policy Innovation Box, Patent Box Policy Tax Policy for Employee Benefits H.R.160 - Protect Medical Innovation Act of 2013 S.149 - Medical Device Access and Innovation Protection Acts Tax Extenders H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts Proposed Sectoin 385 Treasury Regulations

Client expense: $540,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Implementation of the Patient Protection and Affordable Care Act (PL 111-148) and the Health Care and Education Reconciliation Act (PL 111-152) Medicare and Medicaid reimbursement policies related to healthcare associated complications, healthcare associated infections,readmission, payment bundling, potentially preventable events and outcomes, and value based purchasing. Comparative effectiveness research and policies Accountable Care Organizations (ACO) Policy Competitive Bidding Policy Regulations and legislation related to the Adoption of International Classification of Diseases, version 10 (ICD-10) Implementation of the Physician Payments Sunshine Act (PL 111-152, Section 6002) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) User Fee Program H.R.160 - Protect Medical Innovation Act S.149 - Medical Device Access and Innovation Protection Act H.R.2 - Medicare Access - CHIP Reauthorization Act H.R.1470 - SGR Repeal & Medicare Provider Payment Modernization Act S.1695, FY2016 Labor/Health and Human Services and Education Appropriations Bill H.R. 3422 VA Vendor Verification Act H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts HR 5273 Helping Hospitals Improve Patient Care Act Medicaid waiver policy Access to dental coverage H.R. 6274, The Hospital Outcomes Act

Client expense: $540,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

International Tax Policy Corporate Tax Reform Medical Device Tax Repeal Research and Development Tax Policy Patent/Innovation Box Tax Policy Innovation Box, Patent Box Policy Tax Policy for Employee Benefits H.R.160 - Protect Medical Innovation Act of 2013 S.149 - Medical Device Access and Innovation Protection Acts Tax Extenders H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts Proposed Sectoin 385 Treasury Regulations

Client expense: $610,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Implementation of the Patient Protection and Affordable Care Act (PL 111-148) and the Health Care and Education Reconciliation Act (PL 111-152) Medicare and Medicaid reimbursement policies related to healthcare associated complications, healthcare associated infections,readmission, payment bundling, potentially preventable events and outcomes, and value based purchasing. Comparative effectiveness research and policies Accountable Care Organizations (ACO) Policy Competitive Bidding Policy Regulations and legislation related to the Adoption of International Classification of Diseases, version 10 (ICD-10) Implementation of the Physician Payments Sunshine Act (PL 111-152, Section 6002) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) User Fee Program H.R.160 - Protect Medical Innovation Act S.149 - Medical Device Access and Innovation Protection Act H.R.2 - Medicare Access - CHIP Reauthorization Act H.R.1470 - SGR Repeal & Medicare Provider Payment Modernization Act S.1695, FY2016 Labor/Health and Human Services and Education Appropriations Bill H.R. 3422 VA Vendor Verification Act H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts HR 5273 Helping Hospitals Improve Patient Care Act Medicaid waiver policy Access to dental coverage

Client expense: $610,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Implementation of the Patient Protection and Affordable Care Act (PL 111-148) and the Health Care and Education Reconciliation Act (PL 111-152) Medicare and Medicaid reimbursement policies related to healthcare associated complications, healthcare associated infections,readmission, payment bundling, and potentially preventable events and outcomes. Comparative effectiveness research and policies Accountable Care Organizations (ACO) Policy Competitive Bidding Policy Regulations and legislation related to the Adoption of International Classification of Diseases, version 10 (ICD-10) Implementation of the Physician Payments Sunshine Act (PL 111-152, Section 6002) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) User Fee Program H.R.160 - Protect Medical Innovation Act S.149 - Medical Device Access and Innovation Protection Act H.R.2 - Medicare Access - CHIP Reauthorization Act H.R.1470 - SGR Repeal & Medicare Provider Payment Modernization Act S.1695, FY2016 Labor/Health and Human Services and Education Appropriations Bill H.R. 3422 VA Vendor Verification Act H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts

Client expense: $1,120,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

International Tax Policy Corporate Tax Reform Medical Device Tax Repeal Research and Development Tax Policy Patent/Innovation Box Tax Policy Innovation Box, Patent Box Policy Tax Policy for Employee Benefits H.R.160 - Protect Medical Innovation Act of 2013 S.149 - Medical Device Access and Innovation Protection Acts Tax Extenders H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts

Client expense: $1,120,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

H.R. 160 - Protect Medical Innovation Act of 2015 (Medical Device Tax) H.R. 636 - Americas Small Business Tax Relief Act (Sec. 179) H.R. 1185 - Responsible Additions and Increases to Sustain Employee (RAISE) Health Benefits Act of 2015 (Flexible Spending Accounts) H.R. 1842 - Indian Health Service Health Professions Tax Fairness Act of 2015 (Student Loan Tax Deduction) H.R. 2029 - Consolidated Appropriations Act, 2016 (Dietary Guidelines; tobacco rider; dental research programs; child nutrition programs; appropriations for IHS, AHRQ, CDC, CMS, HHS, HRSA, NIH/NIDCR, other dental-related agencies) H.R. 2911 - Small Business Healthcare Relief Act (HRAs) H.R. 5447 - Small Business Health Care Relief Act of 2016 (HRAs) S. 149 - Medical Device Access and Innovation Protection Act (Medical Device Tax) S. 536 - Indian Health Service Health Professions Tax Fairness Act of 2015 (Student Loan Tax Deduction) S. 1697 - Small Business Healthcare Relief Act (HRAs) S. 1827 - Small Business Tax Compliance Relief Act of 2015 (Cash accounting) S. 1946 - Tax Relief Extension Act of 2015 (Section 179 tax deduction) S. 3060 - Small Business Health Care Relief Act of 2016 (HRAs) Business Tax Reform

Client expense: $470,000 · 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), Defense, Dept of (DOD), Education, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Internal Revenue Service (IRS), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), SENATE, Small Business Administration (SBA), Veterans Affairs, Dept of (VA)

H.R. 2646 - Helping Families in Mental Health Crisis Act of 2015 H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 6 - 21st Century Cures Act S. 711 - Mental Health First Act of 2015 S. 599 - Improving Access to Emergency Psychiatric Care Act S. 149 - Medical Device Access and Innovation Protection Act H.R. 160 - Protect Medical Innovation Act of 2015 H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015 S. 141 - Protecting Seniors Access to Medicare Act of 2015 H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 S. 1945 - Mental Health Reform Act of 2015 S. 2680 - Mental Health Reform Act of 2016 S. 524 - Comprehensive Addiction and Recovery Act (CARA)

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

H.R. 2646 - Helping Families in Mental Health Crisis Act of 2015 H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 6 - 21st Century Cures Act S. 711 - Mental Health First Act of 2015 S. 599 - Improving Access to Emergency Psychiatric Care Act S. 149 - Medical Device Access and Innovation Protection Act H.R. 160 - Protect Medical Innovation Act of 2015 H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015 S. 141 - Protecting Seniors Access to Medicare Act of 2015 H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 S. 1945 - Mental Health Reform Act of 2015 S. 2680 - Mental Health Reform Act of 2016 S. 524 - Comprehensive Addiction and Recovery Act (CARA)

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 6 - 21st Century Cures Act S. 995 - Bipartisan Congressional Trade Priorities and Accountability Act of 2015 H.R. 2581 - Preservation of Access for Seniors in Medicare Advantage Act of 2015 S. 149 - Medical Device Access and Innovation Protection Act H.R. 160 - Protect Medical Innovation Act of 2015 H.R. 2156 - Medicare Audit Improvement Act of 2015 S. 1268 - Trade Adjustment Assistance Reauthorization Act of 2015 H.R. 1295 - Trade Preferences Extension Act of 2015 H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015 S. 141 - Protecting Seniors Access to Medicare Act of 2015 H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 S.754 - Cybersecurity Information Sharing Act of 2015

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 6 - 21st Century Cures Act S. 995 - Bipartisan Congressional Trade Priorities and Accountability Act of 2015 H.R. 2581 - Preservation of Access for Seniors in Medicare Advantage Act of 2015 S. 149 - Medical Device Access and Innovation Protection Act H.R. 160 - Protect Medical Innovation Act of 2015 H.R. 2156 - Medicare Audit Improvement Act of 2015 S. 1268 - Trade Adjustment Assistance Reauthorization Act of 2015 H.R. 1295 - Trade Preferences Extension Act of 2015 H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015 S. 141 - Protecting Seniors Access to Medicare Act of 2015 H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 S.754 - Cybersecurity Information Sharing Act of 2015

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug user fees. Monitor legislative and administrative action related to dietary supplements. Monitor the implementation of the Patient Protection and Affordable Care Act, P.L. 111-148. Monitor legislative and administrative action related to FDAs Priority Review Voucher Program. S. 149, Medical Device Access and Innovation Protection Act. H.R. 34, 21st Century CURES Act. (P.L. 114-255) H.R. 160, Protect Medical Innovation Act of 2015. H.R. 1537, Advancing Hope Act of 2015.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 34, the 21st Century Cures Act, specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S. 149, the Medical Device Access and Innovation Protection Act. S. 1077, the Advancing Breakthrough Devices for Patients Act. S. 1622, the FDA Device Accountability Act. S. 2737, the Improving Medical Device Innovation Act. Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the Patient Protection and Affordable Care Act, specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 30, Save American Workers Act of 2015 H.R. 160, Protect Medical Innovation Act of 2015 H.R. 248, American Job Protection Act H.R. 879, Ax the Tax on Middle Class Americans' Health Plans Act H.R. 928, To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act H.R. 1189/S. 620, Preserving Employee Wellness Programs Act H.R. 1196, Health Savings Act of 2015 H.R. 1270/S. 709, Restoring Access to Medication Act of 2015 H.R. 2050, Middle Class Health Benefits Tax Repeal Act of 2015 H.R. 2712, Commonsense Reporting and Verification Act of 2015 H.R. 2911, Small Business Healthcare Relief Act H.R. 4469/S.2499, Health Savings Act of 2016 H.R. 5445, Health Care Security Act of 2016 H.R. 5447/S.3060, Small Business Health Care Relief Act of 2016 S. 30, Forty Hours Is Full Time Act of 2015 S. 149, Medical Device Access and Innovation Protection Act S. 183, Jobs and Premium Protection Act S. 305, American Job Protection Act S. 1099, Protecting Affordable Coverage for Employees (PACE) Act S. 1697, Small Business Healthcare Relief Act S. 1996, Commonsense Reporting Act of 2015 S. 2045, Middle Class Health Benefits Tax Repeal Act of 2015 S. 2075, American Worker Health Care Tax Relief Act of 2015 Proposed Regulation on Shared Responsibility for Employers Regarding Health Coverage (78 Fed. Reg. 218-253, January 2, 2013) (to be codified at 26 C.F.R. pts. 1, 54, 301) Proposed Regulation on Information Reporting by Applicable Large Employers on Health Insurance Coverage Offered Under Employer-Sponsored Plans (78 Fed. Reg. 54,996-55,013, September 9, 2013) (to be codified at 26 C.F.R. pt. 301) Proposed Regulation on Information Reporting of Minimum Essential Coverage (78 Fed. Reg. 54,986-54,996, September 9, 2013) (to be codified at 26 C.F.R. pts. 1, 301) Proposed Rule on HHS Notice of Benefit and Payment Parameters for 2017 (80 Fed. Reg. 75,488-75,588, December 2, 2015) (to be codified at 45 C.F.R. pts. 144, 146, 147 et al.) Proposed rule on Nondiscrimination in Health Programs and Activities (80 Fed. Reg. 54,172-54,221, September 8, 2015) (to be codified at 45 C.F.R. pt. 92) Proposed rule on Expatriate Health Plans, Expatriate Health Plan Issuers, and Qualified Expatriates; Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance (81 Fed. Reg. 38,020-38,048, June 10, 2016) IRS Notice on Section 4980I - Excise Tax on High Cost Employer-Sponsored Health Coverage (Notice 2015-16, February 23, 2015) Various issues relating to the Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings accounts (HSAs), health reimbursement accounts (HRAs), and flexible spending accounts (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; House Republican Taskforce on Health Care report, 'A Better Way to Fix Health Care'

Client expense: $18,590,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Industry and Security (BIS), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Communications Commission (FCC), Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Fish & Wildlife Service (USFWS), U.S. Geological Survey (USGS), U.S. Trade Representative (USTR), White House Office

H.R. 160 - Protect Medical Innovation Act of 2015 S. 149 - Medical Device Access and Innovation Protection Act device tax repeal

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

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

H.R.34, 21st Century Cures Act S.149, Medical Device Access and Innovation Protection Act H.R. 160, Protect Medical Innovation Act of 2015

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 149, Medical Device Access and Innovation Protection Act H.R. 160, Protect Medical Innovation Act of 2015

Client expense: $405,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies related to: Physician/nurse practitioner reimbursement Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Adoption of recommendations of the Institute of Medicine report, The Future of Nursing: Leading Change, Advancing Health Medicare Shared Savings Program beneficiary assignment requirements Medicare-Medicaid hospital conditions of participation Evaluation of the Medicare Graduate Nurse Education demonstration Medicare-Medicaid Program Integrity policies Medicaid maintenance of effort requirements Medicaid eligibility expansion and state options Medicaid waiver application procedures Medicaid per capita cap policy options Medicare-Medicaid dual eligible coverage and demonstration Draft Hospital Improvement for Payment (HIP) Act HHS study on the comparability of CHIP coverage and benefits with those of marketplace health plans Medicare provisions of H.R. 1892, the Trade Adjustment Assistance Act H.R. 2 - Medicare Access and CHIP Reauthorization Act H.R. 160/S. 149 - Protect Medical Innovation Act H.R. 546/S. 298 - Advancing Care for Exceptional Kids (ACE Kids) Act H.R. 700 - Stabilize Medicaid and CHIP Coverage Act H.R. 818/S. 861 - Preventing and Reducing Improper Medicare and Medicaid Expenditures (PRIME) Act H.R. 876 - Notice of Observation Treatment and Implication for Care Eligibility (NOTICE) Act H.R. 919 - CHIP Extension and Improvement Act H.R. 1021 - Protecting Integrity of Medicare Act (PIMA) H.R. 1190/S. 141 - Protecting Seniors Access to Medicare Act H.R. 1362 - Medicaid Requiring Expenditures for Public Objectives to be Reflective of Total Spending (Medicaid REPORTS) Act H.R. 1458 - Bundling and Coordinating Post-Acute Care (BACPAC) Act H.R. 1470 - SGR Repeal and Medicare Provider Payment Modernization Act H.R. 2339 - To amend title XIX of the Social Security Act to clarify the treatment of lottery winnings and other lump sum income for purposes of income eligibility under the Medicaid program H.R. 3014 - Medical Controlled Substances Transportation Act H.R. 3134 - Defund Planned Parenthood Act of 2015 H.R. 3292 - Medicare IME Pool Act H.R. 3298 - Medicare Post-Acute Care Value-Based Purchasing Act H.R. 3716 - Ensuring Terminated Providers Are Removed From Medicaid and CHIP Act H.R. 3821/S. 2618 - Medicaid Directory of Caregivers (Medicaid DOC) Act H.R. 4588 - Incentivizing Medicaid Expansion Act of 2016 H.R. 4725 - Common Sense Savings Act of 2016 H.R. 5164 - Rural Hospital Regulatory Relief Act H.R. 5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models H.R. 5210/S. 2736 - Patient Access to Durable Medical Equipment Act H.R. 5273 - Helping Hospitals Improve Patient Care Act of 2016 H.R. 5613/S. 3129 - Continuing Access to Hospitals Act of 2016 S. 257/H.R. 1611 - Protecting Access to Rural Therapy Services Act S. 578/H.R. 1342 - Home Health Care Planning Improvement Act S. 737/H.R. 2253 - Ensuring Access to Primary Care for Women & Children Act S. 1349 - Notice of Observation Treatment and Implication for Care Eligibility (NOTICE) Act S. 1456 - Rural ACO Improvement Act S. 1461 - Extending a moratorium on enforcement of direct physician supervision of outpatient therapeutic services in critical access and small rural hospitals through 2015 S. 2425 - Patient Access and Medicare Protection Act S. 2787 - States Achieve Medicaid Expansion (SAME) Act S. 3130 - Independence at Home Act of 2016

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

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

Department of Health & Human Services: Implementation of Health insurance exchanges; Implementation of Qualified Health Plans; Delivery system reform. HR 34 - 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures. Upton (R-MI) HR 160 & S 149 - Protect Medical Innovation Act of 2015: A bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices. Paulsen (R-MN) and Hatch (R-UT) HR 248 - American Job Protection Act - repeal the ACA's employer responsibility requirements. Boustany (R-LA) HR 954 - CO-OP Consumer Protection Act of 2016: To amend the Internal Revenue Code of 1986 to exempt from the individual mandate certain individuals who had coverage under a terminated qualified health plan funded through the Consumer Operated and Oriented Plan (CO-OP) program. Smith (R-NE) HR 2028 - Further Continuing and Security Assistance Appropriations Act, 2017: Provides continuing appropriations for most federal agencies through the earlier of April 28, 2017, or the enactment of the applicable appropriations legislation. Simpson (R-ID) HR 2050 - Middle Class Health Benefits Tax Repeal Act of 2015: To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Courtney (D-CT) HR 5447 - Small Business Health Care Relief Act of 2016: To provide an exception from certain group health plan requirements for qualified small employer health reimbursement arrangements. Boustany (R-LA) S 123 & HR 221- To repeal the ACA risk corridor program. Rubio (R-FL) & Harris (R-MD) S 157 - To repeal the ACA's Individual mandate, employer responsibility requirements and medical device excise tax. Cassidy (R-LA) S 305 - To repeal the ACA's employer responsibility requirements. Hatch (R-UT) and Alexander (R-TN) S Res 561 - A resolution supporting efforts to increase competition and accountability in the health insurance marketplace, and to extend accessible, quality, affordable health care coverage to every American through the choice of a public insurance plan. Merkley (D-OR) S 2680 - Mental Health Reform Act of 2016: To amend the Public Health Service Act to provide comprehensive mental health reform, and for other purposes. Alexander (R-TN) S 3056 - Creating and Restoring Equal Access to Equivalent Samples Act of 2016: To provide for certain causes of action relating to delays of generic drugs and biosimilar biological products. Leahy (D-VT) S 3297 - Relief from Obamacare Mandate Act of 2016: To amend the Internal Revenue Code of 1986 to provide an exemption to the individual mandate to maintain health coverage for certain individuals whose premium has increased by more than 10 percent, and for other purposes. Cotton (R-AR) S 3326 - State Flexibility to Provide Affordable Health Options Act: To give States the authority to provide temporary access to affordable private health insurance options outside of Obamacare exchanges. Alexander (R-TN)

Client expense: $1,450,000 · Firm income: Not reported

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

Implementation of the Patient Protection and Affordable Care Act (PL 111-148) and the Health Care and Education Reconciliation Act (PL 111-152) Medicare and Medicaid reimbursement policies related to healthcare associated complications, healthcare associated infections,readmission, payment bundling, potentially preventable events and outcomes, and value based purchasing. Comparative effectiveness research and policies Accountable Care Organizations (ACO) Policy Competitive Bidding Policy Regulations and legislation related to the Adoption of International Classification of Diseases, version 10 (ICD-10) Implementation of the Physician Payments Sunshine Act (PL 111-152, Section 6002) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) User Fee Program H.R.160 - Protect Medical Innovation Act S.149 - Medical Device Access and Innovation Protection Act H.R.2 - Medicare Access - CHIP Reauthorization Act H.R.1470 - SGR Repeal & Medicare Provider Payment Modernization Act S.1695, FY2016 Labor/Health and Human Services and Education Appropriations Bill H.R. 3422 VA Vendor Verification Act H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts HR 5273 Helping Hospitals Improve Patient Care Act Medicaid waiver policy Access to dental coverage H.R. 6274, The Hospital Outcomes Act

Client expense: $610,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

International Tax Policy Corporate Tax Reform Medical Device Tax Repeal Research and Development Tax Policy Patent/Innovation Box Tax Policy Innovation Box, Patent Box Policy Tax Policy for Employee Benefits H.R.160 - Protect Medical Innovation Act of 2013 S.149 - Medical Device Access and Innovation Protection Acts Tax Extenders H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts Proposed Section 385 Treasury Regulations U.S. House GOP Tax Payment Border Adjustability Tax Policy

Client expense: $610,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

H.R.34, 21st Century Cures Act (P.L.114-255). H.R.160, Protect Medical Innovation Act of 2015. S.149, Medical Device Access and Innovation Protection Act. Affordable Care Act (P.L.111-148) implementation. Oversight and regulation of medical devices.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.160 - Protect Medical Innovation Act of 2015 & S.149 - Medical Device Access and Innovation Protection Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. H.R. 160, Protect Medical Innovation Act of 2015. S. 149, Medical Device Access and Innovation Protection Act. S. 440, Veterinary Medicine Loan Repayment Program Enhancement Act.

Client expense: $1,870,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

H.R. 160, S. 149, S. 588 bills related to the Medical Device Excise Tax Issues related to the reform of the tax code

Client expense: $650,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Patient Protection and Affordable Care Act (H.R. 3590/Pub. L. 111-148); telemedicine and connected care; remote patient monitoring; Health Care and Education Reconciliation Act (H.R. 4872/Pub. L. 111-152); Protect Medical Innovation Act of 2015 (H.R. 160/S. 149); The Medicare Access and CHIP Reauthorization Act (H.R. 2); Medicare Telehealth Parity Act (H.R. 2948); CONNECT for Health Act (S 2484/HR 4442); Diabetic Eye Disease Prevention Act (H.R. 4642); safe patient handling, FDA reform.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Technology research; telemedicine and connected care; remote patient monitoring; implementation of Patient Protection and Affordable Care Act (H.R. 3590/P.L. 111-148); Health Care and Education Reconciliation Act (H.R. 4872/P.L. 111-152); the Protect Medical Innovation Act (H.R. 160/S. 149); 21st Century Cures Act (H.R. 6/HR 34); The Medicare Access and CHIP Reauthorization Act (H.R. 2); Medicare Telehealth Parity Act (H.R. 2948); CONNECT for Health Act (S 2484/HR 4442); Diabetic Eye Disease Prevention Act (H.R. 4642); safe patient handling, FDA reform.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation H.R. 160 - Protect Medical Innovation Act of 2015 S. 149 - Medical Device Access and Innovation Protection Act

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

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

H.R. 160 - Protect Medical Innovation Act of 2015 S. 149 - Medical Device Access and Innovation Protection Act

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

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

H.R.160, Protect Medical Innovation Act of 2015; S.149, Medical Device Access and Innovation Protection Act. Tax reform; international tax issues; the repeal of the medical device excise tax; manufacturing and taxes.

Client expense: $430,000 · Firm income: Not reported

Government targets: Army, Dept of (Other), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, Transportation Security Administration (TSA), U.S. Customs & Border Protection

- Issues related to promoting competitiveness of the medical technology industry and the impact of federal policies. - H.R. 160, (Protect Medical Innovation Act), S. 149 (Medical Device Access and Innovation Protection Act)and provisions related to repeal of the medical device excise tax. - S.1077 Advancing Breakthrough Devices for Patients Act of 2015, provisions relating to breakthrough pathway.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Corporate Tax Reform - No bill number at this time PL 111-152, Sec. 1405 - Medical Device Excise Tax; H.R.160 - Protect Medical Innovations Act of 2015; S.149 - Medical Device Access and Innovation Protection Act of 2015 S.198: Stop Corporate Inversions Act of 2015 HR.414: Stop Corporate Inversions Act of 2015 S.2666 - Corporate Inverters Earning Stripping Reform Act of 2016 HR.4581 - Stop Corporate Earnings Stripping Act of 2016 International tax reform Sec. 385 Related Party Debt Transactions - proposed and final rule

Client expense: $320,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE

Monitor tax reform proposals relating to corporate and international tax and medical device excise tax repeal; H.R. 160 - Protect Medical Innovation Act of 2015 - entire bill repealing medical device excise tax; S. 149 - Medical Device Access and Innovation Protection Act - entire bill repealing medical device excise tax.

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

Implementation of ICD-10 (International Classification of Diseases 10th Edition); H.R. 160 - Protect Medical Innovation Act of 2015 - entire bill repealing medical device excise tax; S. 149 - Medical Device Access and Innovation Protection Act - entire bill repealing medical device excise tax.

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

Tax proposals relating to the medical device excise tax including H.R.160 - Protect Medical Innovation Act, S.149 - Medical Device Access and Innovation Protection Act; tax policies as they relate to the competitiveness of the medical device industry.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to the repeal of the medical device excise tax including S.149, Medical Device Access and Innovation Protection Act and H.R. 160, Protect Medical Innovation Act.

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

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

Permanent repeal of medical device excise tax (HR 160/S 149)

Client expense: $23,473 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

H.R. 160, Protect Medical Innovation Act of 2015 H.R. 6, 21st Century Cures Act S. 149, Medical Device Access & Innovation Protection Act Senate "Innovation for Healthier Americans" Initiative Policies promoting medical innovation Medical Device User Fees Postmarket Surveilance FDA Inspection Process

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

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

Federal Corporate Tax Rate Foreign Source Income Tax Deferral H.R 160, Protect Medical Innovation Act of 2015 Repatriation S. 149, Medical Device Access & Innovation Protection Act Tax Reform Taxation of Offshore Income International Tax Issues Treasury Anti-inversion Regulation Section 385

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

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

Federal Corporate Tax Rate Foreign Source Income Tax Deferral H.R 160, Protect Medical Innovation Act of 2015 Repatriation S. 149, Medical Device Access & Innovation Protection Act Tax Reform Taxation of Offshore Income International Tax Issues Treasury Anti-inversion Regulation Section 385

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

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