Ensuring Patient Access to Critical Breakthrough Products Act of 2018

Implementation of PL 114-255, 21st Century Cures Act Implementation of PL-111-148, PPACA H.R. 5997, Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Policies promoting medical innovation Heart Valve Disease Awareness Implementation of PL-115-201, FDA Reauthorization Act of 2017 H.R. 184, Protect Medical Innovation Act of 2017 S. 108, Medical Device Access & Innovation Protection Act Implementation of PL 114-10, MACRA Cybersecurity for Healthcare Industry

Client expense: $310,000 · 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), SENATE

Implementation of PL 114-255, 21st Century Cures Act Implementation of PL-111-148, PPACA H.R. 5997, Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Policies promoting medical innovation Heart Valve Disease Awareness Implementation of PL-115-201, FDA Reauthorization Act of 2017 H.R. 184, Protect Medical Innovation Act of 2017 S. 108, Medical Device Access & Innovation Protection Act Implementation of PL 114-10, MACRA Cybersecurity for Healthcare Industry

Client expense: $300,000 · 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), SENATE

CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Antikickback Statute Safeharbors H.R. 5997, Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Heart Valve Disease Awareness National Coverage Decision for TAVR H.R. 6, SUPPORT For Patients and Communitties Act (Sunshine)

Client expense: $300,000 · 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), SENATE

Issues related to deficit reduction and Medicare Issues related to value-based health care and Medicare program integrity, including changes to the Stark laws and Anti-Kickback Statute Issues relating to payment reform, ACOs and Bundling H.R. 5997, Ensuring Patient Access to Critical Breakthrough Products Act H.R. 3635, S. 794 Local Coverage Determination Clarification Act of 2016 Issues related to Protecting Access to Medicare Act Issues related to diagnostics payment reform Issues related to the regulation of, reimbursement for, and access to cancer diagnostics, imaging, and radiation therapies, including passage of H.R. 1892, Bipartisan Budget Act of 2018 S. 2891 related to the expansion of the Sunshine program

Client expense: $530,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CMS Coverage Policies for Medical Devices CMS Payment Policies For Medical Devices HR 5997, Ensuring Patient Access to Critical Breakthrough Pathway Products of 2018

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

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

Policies promoting medical innovation HR 5997, Ensuring Patient Access to Critical Breakthrough Pathway Products of 2018

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

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

H.R.6261 - Improving Choices in Health Care Coverage Act S.3095 - Building a Health Care Workforce for the Future Act H.R.6128 - HSA Employer Flexibility Act H.R.6110 - Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018 H.R.6098 - Family Medical Leave Modernization Act H.R.6097 - State-Based Universal Health Care Act of 2018 H.R.6082 - Overdose Prevention and Patient Safety Act H.R.6 - SUPPORT for Patients and Communities Act S.3063 - Health Insurance Tax Relief Act of 2018 H.R.6071 - SERV Communities Act S.3053 - CHIP Mental Health and Addiction Parity Act S.3048 - Examining Opioid Treatment Infrastructure Act of 2018 H.R.6050 - Increasing Access to Care Act S.3016 - Action for Dental Health Act of 2018 S.3000 - Patient Advocacy Transparency Act H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 H.Res.915 - Expressing the sense of the Congress in support of protecting patients' access to medically appropriate, evidence-based healthcare and information, and the ethical and professional obligations of healthcare professionals to provide that care and information H.R.5966 - Women Veterans Access to Quality Care Act of 2018 H.R.5965 - Access to Infertility Treatment and Care Act H.R.5963 - To delay the reimposition of the annual fee on health insurance providers until after 2020 S.2960 - Access to Infertility Treatment and Care Act S.Res.526 - A resolution expressing the sense of the Senate that politicians should not interfere with a woman's personal health care decisions or attempt to prevent providers from offering their full medical recommendations to their patients H.R.5942 - Health Equity and Accountability Act of 2018 H.R.5933 - Substance Abuse Prevention Act of 2018 H.R.5932 - Increasing Access to Mental Health in Schools Act H.R.5925 - CRISIS Act S.2934 - Increasing Access to Mental Health in Schools Act H.R.5917 - Professional's Access to Health Workforce Integration Act of 2018 H.R.5914 - To require a study and report on policy and regulatory changes that may have contributed to the opioid epidemic S.2920 - Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act of 2018 S.2912 - Opioid Addiction Treatment Programs Enhancement Act H.R.6144 - Know the Lowest Price Act of 2018 S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S.2680 - Opioid Crisis Response Act of 2018 H.R.5511 - Healthy Communities Act of 2018 H.R.5491 - Rural Health Insurance Act of 2018 H.R.5455 - Accelerating Biomedical Research Act H.R.5641 - State Offices of Rural Health Reauthorization Act of 2018 H.R.5625 - Easy Enrollment Act of 2018 H.R.5624 - Pathway to Universal Coverage Act of 2018 H.R.5603 - Access to Telehealth Services for Substance Use Disorders Act S.2732 - Defending Access to Mental Health Care Act H.R.5699 - HOST Act of 2018 S.2802 - Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2018 H.R.5725 - BEST Act S.2902 - Better Data Sharing to Combat the Opioid Crisis Act S.2901 - eTREAT Act H.R.5892 - To establish an Advisory Committee on Opioids and the Workplace to advise the Secretary of Labor on actions the Department of Labor can take to address the impact of opioid abuse on the workplace H.R.5858 - Primary Care Patient Protection Act of 2018 S.2875 - COMBAT Act of 2018 H.R.5795 - Overdose Prevention and Patient Safety Act S.2851 - Regional Health Care Emergency Preparedness and Response Systems Act H.R.5775 - Providing Reliable Options for Patients and Educational Resources Act of 2018 H.R.5769 - Expanding Access to Treatment Act S. 2608 - Reducing Opioid Risk Act S. 2589 - Comprehensive Opioid Recovery Centers Act of 2018 S. 2582 - Consumer Health Insurance Protection Act of 2018 S. 2554 - Patient Right to Know Drug Prices Act H.R. 5258 - Affordable Health Insurance for the Middle Class Act H.R. 5254 - To direct the Secretary of HHS to conduct a study on the feasibility of expanding eligibility for enrollment in Medicare Advantage plans to individuals enrolled under the Medicaid program or enrolled under a group health plan H.R. 5223 - Health Care Workplace Violence Prevention Act S. 2507 - Improving Choice in Health Care Coverage Act H.R. 5155 - Undo Sabotage and Expand Affordability of Health Insurance Act of 2018 S. 2496 - Small Business Health Account Act of 2018 S. 2494 - Fair Care Act H.R. 5138 - Bipartisan HSA Improvement Act of 2018 H.R. 5124 - Community Action Opioid Response Act of 2018 H.R. 5097 - PAVE Act of 2018 H.R. 5080 - COMBAT Act of 2018 H.R. 5062 - Advancing Access to Precision Medicine Act H.R. 5047 - VA Community Care Enhancement Act S. 2437 - Opioid Response Enhancement Act S. 2415 - Accelerating Kids Access to Care Act H.R. 4978 - Chronic Disease Management Act of 2018 S. 2410 - Chronic Disease Management Act of 2018 H.R. 4952 - To direct the Secretary of HHS to conduct a study and submit a report on the effects of the inclusion of quality increases in the determination of blended benchmark amounts under part C of the Medicare program H.R. 4938 - Respond NOW Act H.R. 4894 - Harmful Tax Prevention Act H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R. 4831 - Healthcare Tax Relief Act H.R. 4820 - ASK Act S. 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 4808 - Transparent Health Care Pricing Act of 2018 S. 2312 - HELP Act H.R. 4784 - ACA OUTREACH Act H.R. 4778 - Behavioral Health Coverage Transparency Act of 2018 S. 2302 - Access to Independent Health Insurance Advisors Act of 2018 S. 2301 - Behavioral Health Coverage Transparency Act of 2018 H.R. 4575 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. S. 2303 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. H.R. 1625 - Consolidated Appropriations Act, 2018 S. 2553 - Know the Lowest Price Act of 2018 H.R. 5343 - Prescription Transparency Act of 2018 H.R. 5150 - Protecting Medicare from Excessive Price Increases Act of 2018 H.R. 4874 - End The Shutdown Act of 2018 H.R. 4872 - End The Shutdown Act of 2018 H.R. 5104 - A bill to amend title XVIII of the Social Security Act to provide for a special enrollment period under Medicare for individuals enrolled in COBRA continuation coverage, and for other purposes H.R. 6 - SUPPORT for Patients and Communities Act S. 2554 - Patient Right to Know Drug Prices Act S. 2553 - Know the Lowest Price Act of 2018 H.R. 302 - FAA Re authorization Act of 2018 H. R. 6662 - Empowering Seniors Enrollment Decision Act of 2018 H.R. 6305 - Bipartisan HSA Improvement Act of 2018 H.R. 6312 - Personal Health Investment Today (PHIT) Act H.R. 6309 - To amend the Internal Revenue Code of 1986 to allow individuals entitled to Medicare Part A by reason of being over age 65 to contribute to health savings accounts H.R. 4616 - To amend the Patient Protection and Affordable Care Act to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 6311 - To amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to modify the definition of qualified health plan for purposes of the health insurance premium tax credit and to allow individuals purchasing health insurance in the individual market to purchase a lower premium copper plan

Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule HR5997 - Ensuring Patient Access to Critical Breakthrough Products Act FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices Working draft of Comprehensive Addiction & Recovery Act 2.0 (CARA 2.0) to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain House & Senate Opioid Legislation: HELP Bills, E&C Bills, W&M bills, Senate Finance Bills aimed at addressing the national opioid epidemic; specifically the role of FDA approved alternative treatments for Chronic pain and opioid abuse. Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic.

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

Issues related to the opioid crisis. H.R. 5997 Ensuring Patient Access to Critical Breakthrough Products Act of 2018

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to deficit reduction and Medicare Issues related to value-based health care and Medicare program integrity, including changes to the Stark laws and Anti-Kickback Statute Issues relating to payment reform, ACOs and Bundling Issues related to the development of Medicare payments for telehealth and remote monitoring services H.R. 5997, Ensuring Patient Access to Critical Breakthrough Products Act H.R. 3635, S. 794 Local Coverage Determination Clarification Act of 2016 Issues related to Protecting Access to Medicare Act Issues related to diagnostics payment reform Issues related to the regulation of, reimbursement for, and access to cancer diagnostics, imaging, and radiation therapies, including passage of H.R. 1892, Bipartisan Budget Act of 2018 S. 2891 related to the expansion of the Sunshine program

Client expense: $700,000 · Firm income: Not reported

Policies promoting medical innovation HR 5997, Ensuring Patient Access to Critical Breakthrough Pathway Products of 2018

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

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

CMS Coverage Policies for Medical Devices CMS Payment Policies For Medical Devices HR 5997, Ensuring Patient Access to Critical Breakthrough Pathway Products of 2018

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

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

Issues related to the opioid crisis. H.R. 5997 Ensuring Patient Access to Critical Breakthrough Products Act of 2018

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6261 - Improving Choices in Health Care Coverage Act S.3095 - Building a Health Care Workforce for the Future Act H.R.6128 - HSA Employer Flexibility Act H.R.6110 - Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018 H.R.6098 - Family Medical Leave Modernization Act H.R.6097 - State-Based Universal Health Care Act of 2018 H.R.6082 - Overdose Prevention and Patient Safety Act H.R.6 - SUPPORT for Patients and Communities Act S.3063 - Health Insurance Tax Relief Act of 2018 H.R.6071 - SERV Communities Act S.3053 - CHIP Mental Health and Addiction Parity Act S.3048 - Examining Opioid Treatment Infrastructure Act of 2018 H.R.6050 - Increasing Access to Care Act S.3016 - Action for Dental Health Act of 2018 S.3000 - Patient Advocacy Transparency Act H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 H.Res.915 - Expressing the sense of the Congress in support of protecting patients' access to medically appropriate, evidence-based healthcare and information, and the ethical and professional obligations of healthcare professionals to provide that care and information H.R.5966 - Women Veterans Access to Quality Care Act of 2018 H.R.5965 - Access to Infertility Treatment and Care Act H.R.5963 - To delay the reimposition of the annual fee on health insurance providers until after 2020 S.2960 - Access to Infertility Treatment and Care Act S.Res.526 - A resolution expressing the sense of the Senate that politicians should not interfere with a woman's personal health care decisions or attempt to prevent providers from offering their full medical recommendations to their patients H.R.5942 - Health Equity and Accountability Act of 2018 H.R.5933 - Substance Abuse Prevention Act of 2018 H.R.5932 - Increasing Access to Mental Health in Schools Act H.R.5925 - CRISIS Act S.2934 - Increasing Access to Mental Health in Schools Act H.R.5917 - Professional's Access to Health Workforce Integration Act of 2018 H.R.5914 - To require a study and report on policy and regulatory changes that may have contributed to the opioid epidemic S.2920 - Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act of 2018 S.2912 - Opioid Addiction Treatment Programs Enhancement Act H.R.6144 - Know the Lowest Price Act of 2018 S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S.2680 - Opioid Crisis Response Act of 2018 H.R.5511 - Healthy Communities Act of 2018 H.R.5491 - Rural Health Insurance Act of 2018 H.R.5455 - Accelerating Biomedical Research Act H.R.5641 - State Offices of Rural Health Reauthorization Act of 2018 H.R.5625 - Easy Enrollment Act of 2018 H.R.5624 - Pathway to Universal Coverage Act of 2018 H.R.5603 - Access to Telehealth Services for Substance Use Disorders Act S.2732 - Defending Access to Mental Health Care Act H.R.5699 - HOST Act of 2018 S.2802 - Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2018 H.R.5725 - BEST Act S.2902 - Better Data Sharing to Combat the Opioid Crisis Act S.2901 - eTREAT Act H.R.5892 - To establish an Advisory Committee on Opioids and the Workplace to advise the Secretary of Labor on actions the Department of Labor can take to address the impact of opioid abuse on the workplace H.R.5858 - Primary Care Patient Protection Act of 2018 S.2875 - COMBAT Act of 2018 H.R.5795 - Overdose Prevention and Patient Safety Act S.2851 - Regional Health Care Emergency Preparedness and Response Systems Act H.R.5775 - Providing Reliable Options for Patients and Educational Resources Act of 2018 H.R.5769 - Expanding Access to Treatment Act S. 2608 - Reducing Opioid Risk Act S. 2589 - Comprehensive Opioid Recovery Centers Act of 2018 S. 2582 - Consumer Health Insurance Protection Act of 2018 S. 2554 - Patient Right to Know Drug Prices Act H.R. 5258 - Affordable Health Insurance for the Middle Class Act H.R. 5254 - To direct the Secretary of HHS to conduct a study on the feasibility of expanding eligibility for enrollment in Medicare Advantage plans to individuals enrolled under the Medicaid program or enrolled under a group health plan H.R. 5223 - Health Care Workplace Violence Prevention Act S. 2507 - Improving Choice in Health Care Coverage Act H.R. 5155 - Undo Sabotage and Expand Affordability of Health Insurance Act of 2018 S. 2496 - Small Business Health Account Act of 2018 S. 2494 - Fair Care Act H.R. 5138 - Bipartisan HSA Improvement Act of 2018 H.R. 5124 - Community Action Opioid Response Act of 2018 H.R. 5097 - PAVE Act of 2018 H.R. 5080 - COMBAT Act of 2018 H.R. 5062 - Advancing Access to Precision Medicine Act H.R. 5047 - VA Community Care Enhancement Act S. 2437 - Opioid Response Enhancement Act S. 2415 - Accelerating Kids Access to Care Act H.R. 4978 - Chronic Disease Management Act of 2018 S. 2410 - Chronic Disease Management Act of 2018 H.R. 4952 - To direct the Secretary of HHS to conduct a study and submit a report on the effects of the inclusion of quality increases in the determination of blended benchmark amounts under part C of the Medicare program H.R. 4938 - Respond NOW Act H.R. 4894 - Harmful Tax Prevention Act H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R. 4831 - Healthcare Tax Relief Act H.R. 4820 - ASK Act S. 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 4808 - Transparent Health Care Pricing Act of 2018 S. 2312 - HELP Act H.R. 4784 - ACA OUTREACH Act H.R. 4778 - Behavioral Health Coverage Transparency Act of 2018 S. 2302 - Access to Independent Health Insurance Advisors Act of 2018 S. 2301 - Behavioral Health Coverage Transparency Act of 2018 H.R. 4575 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. S. 2303 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. H.R. 1625 - Consolidated Appropriations Act, 2018 S. 2553 - Know the Lowest Price Act of 2018 H.R. 5343 - Prescription Transparency Act of 2018 H.R. 5150 - Protecting Medicare from Excessive Price Increases Act of 2018 H.R. 4874 - End The Shutdown Act of 2018 H.R. 4872 - End The Shutdown Act of 2018 H.R. 5104 - A bill to amend title XVIII of the Social Security Act to provide for a special enrollment period under Medicare for individuals enrolled in COBRA continuation coverage, and for other purposes H.R. 6 - SUPPORT for Patients and Communities Act S. 2554 - Patient Right to Know Drug Prices Act S. 2553 - Know the Lowest Price Act of 2018 H.R. 302 - FAA Re authorization Act of 2018 H. R. 6662 - Empowering Seniors Enrollment Decision Act of 2018 H.R. 6305 - Bipartisan HSA Improvement Act of 2018 H.R. 6312 - Personal Health Investment Today (PHIT) Act H.R. 6309 - To amend the Internal Revenue Code of 1986 to allow individuals entitled to Medicare Part A by reason of being over age 65 to contribute to health savings accounts H.R. 4616 - To amend the Patient Protection and Affordable Care Act to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 6311 - To amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to modify the definition of qualified health plan for purposes of the health insurance premium tax credit and to allow individuals purchasing health insurance in the individual market to purchase a lower premium copper plan

Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule HR5997 - Ensuring Patient Access to Critical Breakthrough Products Act FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices Working draft of Comprehensive Addiction & Recovery Act 2.0 (CARA 2.0) to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain House & Senate Opioid Legislation: HELP Bills, E&C Bills, W&M bills, Senate Finance Bills aimed at addressing the national opioid epidemic; specifically the role of FDA approved alternative treatments for Chronic pain and opioid abuse. HR6 -Substance Use-Disorder Prevention that Promises Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S2680 - Opioid Crisis Response Act (OCRA) - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S3120 - Helping to End Addiction & Lessen Substance Abuse Disorders Act (HEAL Act) - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018(Sunshine Expansion Act) - Specifically, transparency and medical device's role in the opioid epidemic.

CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Antikickback Statute Safeharbors H.R. 5997, Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Heart Valve Disease Awareness National Coverage Decision for TAVR H.R. 6, SUPPORT For Patients and Communitties Act (Sunshine)

Client expense: $250,000 · 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), SENATE

Implementation of PL 114-255, 21st Century Cures Act Implementation of PL-111-148, PPACA H.R. 5997, Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Policies promoting medical innovation Heart Valve Disease Awareness Implementation of PL-115-201, FDA Reauthorization Act of 2017 H.R. 184, Protect Medical Innovation Act of 2017 S. 108, Medical Device Access & Innovation Protection Act Implementation of PL 114-10, MACRA Cybersecurity for Healthcare Industry

Client expense: $250,000 · 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), SENATE

Medicare reimbursement policy for chronic wound healing products H.R. 5997 (Ensuring Patient Access to Critical Breakthrough Products Act of 2018), all provisions Implementation of Public Law 115-141 (Consolidated Appropriations Act, 2018), Section 1301, regarding Medicare reimbursement policy for wound healing products

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6261 - Improving Choices in Health Care Coverage Act S.3095 - Building a Health Care Workforce for the Future Act H.R.6128 - HSA Employer Flexibility Act H.R.6110 - Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018 H.R.6098 - Family Medical Leave Modernization Act H.R.6097 - State-Based Universal Health Care Act of 2018 H.R.6082 - Overdose Prevention and Patient Safety Act H.R.6 - SUPPORT for Patients and Communities Act S.3063 - Health Insurance Tax Relief Act of 2018 H.R.6071 - SERV Communities Act S.3053 - CHIP Mental Health and Addiction Parity Act S.3048 - Examining Opioid Treatment Infrastructure Act of 2018 H.R.6050 - Increasing Access to Care Act S.3016 - Action for Dental Health Act of 2018 S.3000 - Patient Advocacy Transparency Act H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 H.Res.915 - Expressing the sense of the Congress in support of protecting patients' access to medically appropriate, evidence-based healthcare and information, and the ethical and professional obligations of healthcare professionals to provide that care and information H.R.5966 - Women Veterans Access to Quality Care Act of 2018 H.R.5965 - Access to Infertility Treatment and Care Act H.R.5963 - To delay the reimposition of the annual fee on health insurance providers until after 2020 S.2960 - Access to Infertility Treatment and Care Act S.Res.526 - A resolution expressing the sense of the Senate that politicians should not interfere with a woman's personal health care decisions or attempt to prevent providers from offering their full medical recommendations to their patients H.R.5942 - Health Equity and Accountability Act of 2018 H.R.5933 - Substance Abuse Prevention Act of 2018 H.R.5932 - Increasing Access to Mental Health in Schools Act H.R.5925 - CRISIS Act S.2934 - Increasing Access to Mental Health in Schools Act H.R.5917 - Professional's Access to Health Workforce Integration Act of 2018 H.R.5914 - To require a study and report on policy and regulatory changes that may have contributed to the opioid epidemic S.2920 - Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act of 2018 S.2912 - Opioid Addiction Treatment Programs Enhancement Act H.R.6144 - Know the Lowest Price Act of 2018 S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S.2680 - Opioid Crisis Response Act of 2018 H.R.5511 - Healthy Communities Act of 2018 H.R.5491 - Rural Health Insurance Act of 2018 H.R.5455 - Accelerating Biomedical Research Act H.R.5641 - State Offices of Rural Health Reauthorization Act of 2018 H.R.5625 - Easy Enrollment Act of 2018 H.R.5624 - Pathway to Universal Coverage Act of 2018 H.R.5603 - Access to Telehealth Services for Substance Use Disorders Act S.2732 - Defending Access to Mental Health Care Act H.R.5699 - HOST Act of 2018 S.2802 - Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2018 H.R.5725 - BEST Act S.2902 - Better Data Sharing to Combat the Opioid Crisis Act S.2901 - eTREAT Act H.R.5892 - To establish an Advisory Committee on Opioids and the Workplace to advise the Secretary of Labor on actions the Department of Labor can take to address the impact of opioid abuse on the workplace H.R.5858 - Primary Care Patient Protection Act of 2018 S.2875 - COMBAT Act of 2018 H.R.5795 - Overdose Prevention and Patient Safety Act S.2851 - Regional Health Care Emergency Preparedness and Response Systems Act H.R.5775 - Providing Reliable Options for Patients and Educational Resources Act of 2018 H.R.5769 - Expanding Access to Treatment Act S. 2608 - Reducing Opioid Risk Act S. 2589 - Comprehensive Opioid Recovery Centers Act of 2018 S. 2582 - Consumer Health Insurance Protection Act of 2018 S. 2554 - Patient Right to Know Drug Prices Act H.R. 5258 - Affordable Health Insurance for the Middle Class Act H.R. 5254 - To direct the Secretary of HHS to conduct a study on the feasibility of expanding eligibility for enrollment in Medicare Advantage plans to individuals enrolled under the Medicaid program or enrolled under a group health plan H.R. 5223 - Health Care Workplace Violence Prevention Act S. 2507 - Improving Choice in Health Care Coverage Act H.R. 5155 - Undo Sabotage and Expand Affordability of Health Insurance Act of 2018 S. 2496 - Small Business Health Account Act of 2018 S. 2494 - Fair Care Act H.R. 5138 - Bipartisan HSA Improvement Act of 2018 H.R. 5124 - Community Action Opioid Response Act of 2018 H.R. 5097 - PAVE Act of 2018 H.R. 5080 - COMBAT Act of 2018 H.R. 5062 - Advancing Access to Precision Medicine Act H.R. 5047 - VA Community Care Enhancement Act S. 2437 - Opioid Response Enhancement Act S. 2415 - Accelerating Kids Access to Care Act H.R. 4978 - Chronic Disease Management Act of 2018 S. 2410 - Chronic Disease Management Act of 2018 H.R. 4952 - To direct the Secretary of HHS to conduct a study and submit a report on the effects of the inclusion of quality increases in the determination of blended benchmark amounts under part C of the Medicare program H.R. 4938 - Respond NOW Act H.R. 4894 - Harmful Tax Prevention Act H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R. 4831 - Healthcare Tax Relief Act H.R. 4820 - ASK Act S. 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 4808 - Transparent Health Care Pricing Act of 2018 S. 2312 - HELP Act H.R. 4784 - ACA OUTREACH Act H.R. 4778 - Behavioral Health Coverage Transparency Act of 2018 S. 2302 - Access to Independent Health Insurance Advisors Act of 2018 S. 2301 - Behavioral Health Coverage Transparency Act of 2018 H.R. 4575 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. S. 2303 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. H.R. 1625 - Consolidated Appropriations Act, 2018 S. 2553 - Know the Lowest Price Act of 2018 H.R. 5343 - Prescription Transparency Act of 2018 H.R. 5150 - Protecting Medicare from Excessive Price Increases Act of 2018 H.R. 4874 - End The Shutdown Act of 2018 H.R. 4872 - End The Shutdown Act of 2018 H.R. 5104 - A bill to amend title XVIII of the Social Security Act to provide for a special enrollment period under Medicare for individuals enrolled in COBRA continuation coverage, and for other purposes

CMS Coverage Policies For Medical Devices Implementation of PL 114-255, 21st Century Cures Act CMS Payment Policies for Medical Devices Antikickback Statute Safeharbors H.R. 5997, Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Heart Valve Disease Awareness National Coverage Decision for TAVR Reporting of transfer of value to healthcare providers (Sunshine)

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), SENATE, Treasury, Dept of

Implementation of PL 114-255, 21st Century Cures Act Implementation of PL-111-148, PPACA H.R.5997, Ensuring Patient Access to Critical Breakthrough Products Act of 2018 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 S. 108, Medical Device Access & Innovation Protection Act Postmarket Surveillance Implementation of PL 114-10, MACRA Cybersecurity for Healthcare Industry

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), SENATE, Treasury, Dept of

Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule HR5997 - Ensuring Patient Access to Critical Breakthrough Products Act FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices Working draft of Comprehensive Addiction & Recovery Act 2.0 (CARA 2.0) to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain House & Senate Opioid Legislation: OCRA and other HELP Bills, E&C Bills, W&M bills, Senate Finance Bills aimed at addressing the national opioid epidemic; specifically the role of FDA approved alternative treatments for Chronic pain and opioid abuse. HR6 -Substance Use-Disorder Prevention that Promises Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S2680 - Opioid Crisis Response Act (OCRA) - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S3120 - Helping to End Addiction & Lessen Substance Abuse Disorders Act (HEAL Act) - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018(Sunshine Expansion Act) - Specifically, transparency and medical device's role in the opioid epidemic.

Policies promoting medical innovation HR 5997, Ensuring Patient Access to Critical Breakthrough Pathway Products of 2018

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

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

CMS Coverage Policies for Medical Devices CMS Payment Policies For Medical Devices HR 5997, Ensuring Patient Access to Critical Breakthrough Pathway Products of 2018

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

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