Closing Loopholes for Orphan Drugs Act

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing.

Client expense: $2,620,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R.3 - Lower Drug Costs Now Act of 2019 Prescription Drug Pricing Reduction Act (PDPRA) of 2019 S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation

Client expense: $2,620,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing.

Client expense: $1,620,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part D

Client expense: $1,620,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Repeal of the Affordable Care Act Development of legislation to protect essential hospitals Issues related to telehealth Mental Health Essential Health Benefits created by the Affordable Care Act Access to hospital emergency services Issues related to the 340B Drug Pricing Program 340B dug pricing program CMS OPPS 340B rule moratorium-related legislation 42 CFR Part 2 CREATES Act-H.R.965 Cassidy Surprise Billing Draft Protecting Patients from Surprise Medical Bills Excellence in Metal Health Act (S.824/H.R.1767) Patient Centered Outcomes Research Institute Funding No Surprises Act Lower Health Care Costs Act Surprise Medical Bills H.R.4004 - Social Determinants Accelerator Act of 2019 S.2986 - Social Determinants Accelerator Act of 2019 H.R.2328 - Reauthorizing and Extending America's Community Health Act S.2723 - Mitigating Emergency Drug Shortages Act H.R.4995 - Maternal Health Quality Improvement Act of 2019 H.R.2889 - Closing Loopholes for Orphan Drugs Act

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing.

Client expense: $2,610,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R.3 - Lower Drug Costs Now Act of 2019 Prescription Drug Pricing Reduction Act (PDPRA) of 2019 S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation

Client expense: $2,610,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part D

Client expense: $1,610,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing.

Client expense: $1,610,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to Right to Try - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part D

Client expense: $2,950,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety, and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement, and pricing. - Issues related to healthcare legislation

Client expense: $2,950,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

340B Drug Discount Program Resident Physician Shortage Reduction Act Graduate Medical Education Disproportionate Share Hospital payments Childrens Health Insurance Program Medicare Dependent Hospital Program (MDH) Medicaid Low Volume Payments (LV) H.R. 1955, S. 872 - Rural Hospital Access Act H.R. 2889, Closing Loopholes for Orphan Drugs Act Medicare Wage Index Federal Medical Assistance Percentage Extension Inpatient Prospective Payment System Outpatient Prospective Payment System Bad debt/charity care Hospital Outpatient Department payments H.R. 4392, Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems 340B Drug Discount program legislation H.R. 4710, 340B PAUSE Act S. 2453, Ensuring the Value of the 340B Program Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to Right to Try - Issues related to drug importation - Issues related to Part D Medicare Program including coverage gap and other offsets

Client expense: $1,480,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation

Client expense: $1,480,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Insurance market policies (Bipartisan Health Care Stabilization Act; Short-term, Limited Duration Health Insurance rule; Association Health Plans rule) Risk adjustment payments Cost sharing reduction payments Insurance navigator funding 340B Drug Pricing Program (H.R. 4392; H.R. 4710, 340B PAUSE Act; S. 2453, Ensuring the Value of the 340B Program Act; H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act; H.R. 2889, Closing Loopholes for Orphan Drugs Act; H.R. 5598, 340B Optimization Act; H.R. 6240, Drug Discount Accountability Act; H.R. 6273, Creating Access to Rape Kit Exams (CARE) for Survivors Act) Opioid issues (S. 2680, the Opioid Crisis Response Act of 2018; H.R. 5176, Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act; H.R. 5009, Jessies Law; H.R. 5818 / S. 2843, the Opioid Workforce Act; H.R. 5797, the IMD CARE Act; H.R. 6082/H.R. 5795, the Overdose Prevention and Patient Safety Act; S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act; S. 2460, Every Prescription Conveyed Securely Act; S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act; H.R. 5582, the Abuse Deterrent Access Act; H.R. 5685, the Medicare Opioid Safety Education Act; Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018; H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; S. 2899, Caring Recovery for Infants and Babies Act; S. 2898, Medication-Assisted Treatment Improvement Act; S.2911, Enhancing Patient Access to Non-Opioid Treatment Options) IV and medication shortages Drug prices (American Patients First, Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs; S. 2554 / H.R. 6143, Patient Right to Know Drug Prices Act; S. 2553, Know the Lowest Price Act; H.R. 6733, Know the Cost Act) Draft Protecting Patients from Surprise Medical Bills Act HIPAA policy in mental and behavioral health information sharing 21st Century Cures Act implementation Pandemic and All Hazards Preparedness Reauthorization, including Hospital Preparedness Program (S. 2852, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2018) S.781/ HR 1876. Good Samaritan Health Professional Act of 2017 Health workforce reauthorizations (H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 3728, the Educating Medical Professionals and Optimizing Workforce Efficiency Readiness (EMPOWER) Act; H.R. 1676, the Palliative Care and Hospice Education and Training Act Consumer Directed Health Plans Legislation (H.R. 6311 would modify the definition of a qualified health plan and allow individuals purchasing health insurance in the individual market to purchase a "copper" plan or use the premium tax credit to buy off-marketplace coverage; H.R. 6301 to allow CDHPs to provide coverage for services like telehealth, chronic disease management, or primary care visits below the minimum deductible; H.R. 6317 to allow coverage of direct primary care service arrangements; H.R. 6305 to permit use of CDHPs to receive certain employment-related health services like onsite clinics; H.R. 6309 to allow individuals only enrolled in Medicare Part A to contribute to health savings accounts; H.R. 6199 to include certain over-the-counter medical products as qualified medical expenses; H.R. 6306 to increase the current contribution limits for HSAs; H.R. 6312, Personal Health Investment Today (PHIT) Act to count sports equipment and exercise costs toward medical expenses; H.R. 6313 to allow carry-forward of flexible spending account balances each year; H.R. 6314 to allow bronze and catastrophic plans in connection with health savings accounts, allowing plans categorized as catastrophic and bronze in the individual and small group markets to qualify for HSA contributions) H.R. 4616 to delay the implementation of the excise tax on high cost employer-sponsored health coverage; and place a moratorium on the employer mandate Liver allocation policy

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.J.RES.63 - A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury, Secretary of Labor, and Secretary of Health and Human Services relating to "Short-Term, Limited Duration Insurance". S.3411 - Affordable Medications Act - comprehensive legislation to address rising prescription drug prices CURE High Drug Prices Act - prevent price gouging by pharmaceutical companies S.3485 - Basic Health Program Expansion Act of 2018 - allow States to expand basic health programs to cover more low-income individuals at lower cost. H.R.5977 - MOMMA's Act - improve Federal efforts with respect to the prevention of maternal mortality H.R.6478 - Biosimilars Competition Act of 2018 - enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products S.3194 - Capping Prescription Costs Act of 2018 - cap prescription drug cost-sharing to $250 per month for each enrolled individual, or $500 for each family starting in 2020 H.R.2889 - Closing Loopholes for Orphan Drugs Act - revise the 340B Drug Pricing Program, which currently requires drug manufacturers to discount orphan drugs (drugs for rare conditions) for certain entities covered by the program. The bill discounts orphan drugs that are not being used to treat rare conditions for all entities covered by the program H.R.5942 - Health Equity and Accountability Act of 2018 - lobbied in support of entire bill; specifically lobbied in support of TITLE IV-IMPROVING HEALTH CARE ACCESS AND QUALITY - Subtitle C-Advancing Health Equity Through Payment And Delivery Reform. H.R.2422 - Action for Dental Health Act of 2017 - HHS provides grants to improve essential oral health care for low-income and other underserved individuals by breaking down barriers to care S.974 - CREATES Act of 2017 - facilitate the timely entry of lower-cost generic and biosimilar versions of drugs and biological products S.Res.581 - A resolution authorizing the Senate Legal Counsel to represent the Senate in Texas v. United States, No. 4:18-cv-00167-O (N.D. Tex.) Reducing Costs for Out-of-Network Services Act of 2018 - cap the amount that hospitals and physicians could charge uninsured patients and out-of-network patients who have individual market coverage Surprise billing - draft legislation to prevent surprise medical billing of patients.

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

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

H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, FY2019, Medical Center related initiatives; and Opioid related issues Medical Center related initiatives H.R.4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes, 340B issues H.R.4710, 340B Protecting Access for the Underserved and Safety-net Entities (PAUSE) Act, generally S.2453, Ensuring the Value of the 340B Program Act of 2018, generally H.R.2889, Closing Loopholes for Orphan Drugs Act, generally S.2312, Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act, generally S.356/H.R.1027, Hallways to Health Act, generally H.R.5150, Protecting Medicare from Excessive Price Increases Act of 2018, generally H.R.5598, 340B Optimization Act, generally H.R.6071, Stretching Entity Resources for Vulnerable (SERV) Communities Act, generally H.R.5498, Rural Hospital Frontier Fairness Act, generally H.R.6, SUPPORT for Patients and Communities Act, generally H.R.6240, Drug Discount Accountability Act, generally H.R.6273, To amend the Public Health Service Act to ensure appropriate care by certain 340B covered entities for victims of sexual assault, and for other purposes, generally H.R.6082, Overdose Prevention and Patient Safety Act, generally

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) Issues related to Medicare and Medicaid coverage and reimbursement including Part B payment, step therapy policy proposal in Medicare Advantage, implementation of value-based reimbursement models Issues related to the 340B Drug Discount Program Issues related to drug pricing Medicare reimbursement for biosimilars MACRA treatment and reimbursement of Part B drugs Issues related to Part D Medicare Program including coverage gap and other offsets

Client expense: $1,370,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R. 6378 - To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 Issues related to the 340B Drug Discount Program Issues relating to drug pricing, reimbursement, step therapy, anti-kickback statute, biosimilars Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. General education about policies impacting pharmaceutical development, approval, reimbursement and pricing

Client expense: $1,370,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

General issues relating to Medicare and Medicaid, issues relating to opioid legislation (HR 6), issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues relating to Medicare and Medicaid, issues relating to opioid legislation (HR 6), issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues relating to Medicare and Medicaid, issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues relating to Medicare and Medicaid, issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues: Issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues: Issues relating to 340B including S 2453, S2312, HR 4710, HR 4392, HR 6071, HR 2889, HR 5598, HR 6240, and HR 6273

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program Resident Physician Shortage Reduction Act Graduate Medical Education Disproportionate Share Hospital payments Childrens Health Insurance Program Medicare Dependent Hospital Program (MDH) Medicaid Low Volume Payments (LV) H.R. 1955, S. 872 - Rural Hospital Access Act H.R. 2889, Closing Loopholes for Orphan Drugs Act Medicare Wage Index Federal Medical Assistance Percentage Extension Inpatient Prospective Payment System Outpatient Prospective Payment System Bad debt/charity care Hospital Outpatient Department payments H.R. 4392, Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems 340B Drug Discount program legislation H.R. 4710, 340B PAUSE Act S. 2453, Ensuring the Value of the 340B Program Act

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA); ACA Regulations; Opioid Epidemic; ACA Stabilization; Health Savings Accounts (HSAs); Postal Reform; Cost Sharing Reductions (CSRs); Health Care Reform Reinsurance; Market Stability; State Flexibility; Pay-fors; Affordability; 1332 Templates; Healthcare Innovation; Risk Adjustment; Department Reform; Drug Pricing; Association Health Plans; Short Term Limited Duration; Air Ambulances; 42 CFR Part 2; Individual Market Reform; CREATES Act; Marketplace Certainty Act; Individual Market Rules; Small Group Market; Rural Health; Health Information Technology HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on a health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN) To repeal Title I of the Patient Protection and Affordable Care Act and to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 1703 Introduced March 23, 2017 by Morgan Griffith (R-VA) To amend the Federal Food, Drug, and Cosmetic Act with respect to determining the intended use of drugs and devices. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR) To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. HR 2026 Pharmaceutical Information Exchange Act Introduced April 6, 2017 by Brett Guthrie (R-VA) To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers. HR 1101 Small Business Health Fairness Act of 2017 Introduced February 16, 2017 by Sam Johnson (R-TX) To amend Title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. HR 2400 Introduced May 8, 2017 by Darrell Issa (R-CA) To amend Title 5, United States Code, to allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program, and for other purposes. HR 708 Introduced January 27, 2017 by Larry Bucshon (R-IN) This bill amends the Public Health Service Act to increase the permissible variation based on age for health insurance premiums for coverage offered in the individual or small group market from a factor of three to a factor of five, or to a factor determined by the state. This applies to plan years starting on or after January 1, 2018. HR 2051 Fast Generics Act of 2017 Introduced April 6, 2017 by David McKinley (R-VA) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2889 Closing Loopholes for Orphan Drugs Act Introduced June 13, 2017 by Peter Welch (D-VT) To amend Title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. HR 2212 CREATES Act Introduced April 27, 2017 by Tom Marino (R-PA) To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Cancer Drug Parity Act of 2017 Introduced by Leonard Lance (R-NJ) To amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 749 Lower Drug Cost Through Competition Act Introduced January 30, 2017 by Kurt Schrader (D-OR) To increase competition in the pharmaceutical industry. HR 4666 Premium Relief Act Introduced December 18, 2017 by Ryan Costello (R-PA) To amend the Public Health Service Act to provide for a Patient and State Stability Fund. HR 3976 Access to Marketplace Insurance Act Introduced October 5, 2017 by Kevin Cramer (R-ND) To amend the Patient Protection and Affordable Care Act to allow for certain third-party payments. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 5228 SCREEN Act Introduced March 8, 2018 by Frank Pallone, Jr. (D-NJ) H.R. 5228 will provide the Food and Drug Administration (FDA) with stronger recall and seizure authority to disrupt the entry of counterfeit and illicit drugs through International Mail Facilities (IMFs). HR 5752 Stop Illicit Drug Importation Act of 2018 Introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administration's (FDA) seizure powers and enhance its authority to detain, refuse, seize, or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess (R-TX) To require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 4998 Health Insurance for Former Foster Youth Act Introduced February 13, 2018 by Karen Bass (D-CA) To amend Title XIX of the Social Security Act to ensure health insurance coverage continuity for former foster youth. HR 5801 Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act Introduced May 15, 2018 by Morgan Griffith (R-VA) To amend Title XIX of the Social Security Act to provide for requirements under the Medicaid program relating to the use of qualified prescription drug monitoring programs and prescribing certain controlled substances. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) To amend Title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare Parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) To amend Title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare Parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids, and for other purposes. HR 5590 Opioid Addiction Action Plan Act Introduced April 24, 2018 by Adam Kinzinger (R-IL) To require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment, and for other purposes. HR 5603 Access to Telehealth Services for Substance Use Disorders Act Introduced April 24, 2018 by Doris Matsui (D-CA) To amend Title XVIIII of the Social Security Act to provide the Secretary of Health and Human Services authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or co-occurring mental health disorder. HR 5605 Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criteria such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extend to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates H.R. 3528, Every Prescription Conveyed Securely Act, which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) To amend Title XVIII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examinations. HR 4684 Ensuring Access to Quality Sober Living Act of 2018 Introduced December 19, 2017 by Judy Chu (D-CA) Authorizes the Substance Abuse and Mental Health Services Administration to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment and sustained recovery from substance use disorders. Recovery housing is increasingly recognized as critical to recovery for many individuals, and includes activities and programs such as mediation, one-on-one counseling, group sessions, peer recovery support, medication management, spiritual engagement, and others. HR 5329 Poison Center Network Enhancement Act of 2018 Introduced March 19, 2018 by Susan Brooks (D-IN) reauthorizes the national network of Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Service Act. The legislation increases the share of poison control center funding that could be provided through federal grants, and authorizes $30 million per year over the 2019-2023 period. HR 5580 STOP Fentanyl Deaths Act of 2018 Introduced April 23, 2018 by Ann Kuster (D-NH) To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5587 Peer Support Communities of Recovery Act Introduced April 23, 2018 by Ben Lujan (D-NM) enhances the Comprehensive Addiction and Recovery Act's Building Communities of Recovery Program and authorizes the Department of Health and Human Services (HHS) to award grants to peer support specialist organizations for the development and expansion of recovery services. Grants shall be awarded to nonprofit organizations that support community-based, peer delivered support, including technical support for the establishment of recovery community organizations, independent, nonprofit groups led by people in recovery and their families. HR 5804 Post-Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) To amend Title XVIII of the Social Security Act to provide for modifications in payment for certain outpatient surgical services. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) To amend Title XVIII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program, and for other purposes. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) To amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) Will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness Act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the U.S. Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12 to 18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across all relevant Federal agencies, evaluate the effectiveness of these activities, and make specific recommendations for actions that agencies can take to better coordinate the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health new authorities to conduct research on innovative non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment of up to $250,000 for participants who agree to work as a SUD treatment professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessie's Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patient's complete health information when making treatment decisions by requirement the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Room Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patient's needs. The bill authorizes $50 million in FY 2019 for the grant program. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA); ACA Regulations; Opioid Epidemic; ACA Stabilization; Health Savings Accounts (HSAs); Postal Reform; Cost Sharing Reductions (CSRs); Health Care Reform Reinsurance; Market Stability; State Flexibility; Pay-fors; Affordability; 1332 Templates; Healthcare Innovation; Risk Adjustment; Department Reform; Drug Pricing; Association Health Plans; Short Term Limited Duration; Air Ambulances; 42 CFR Part 2; Individual Market Reform; CREATES Act; Marketplace Certainty Act; Individual Market Rules; Small Group Market; Rural Health; Health Information Technology HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN) to repeal title I of the Patient Protection and Affordable Care Act and to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) to amend the Federal Food, Drug and Cosmetic Act to ensure eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR) to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs and biosimilar biological products and for other purposes. HR 2400 Introduced May 8, 2017 by Darrell Issa (R-CA) to amend title 5, United States Code. To allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program and for other purposes. HR 708 Introduced January 27, 2017 by Larry Buchshon (R-IN) This bill amends the Public Health Service Act to increase the permissible variation based on age for health insurance premiums for coverage offered in the individual or small group market from a factor of three to a factor of five, or to a factor determined by the state. This applies to plan years starting on or after January 1, 2018. HR 829 Prioritizing the Most Vulnerable Over Lottery Winners Act of 2017 Introduced February 2, 2017 by Fred Upton (R-MI) This bill amends title XIX (Medicaid) to specify how a state must treat qualified lottery winnings and lump sum income for purposes of determining an individuals income-based eligibility for a state Medicaid program. Specifically, a state shall include such winnings or income as income received: (1) in the month in which it was received, if the amount is less than $80,000; (2) over a period of two months, if the amount is at least $80,000 but less than $90,000; (3) over a period of three months, if the amount is at least $90,000 but less than $100,000; and (4) over an additional one-month period for each increment of $10,000 received, not to exceed 120 months. HR 1082 Medicaid Home Improvement Act Introduced February 15, 2017 by Brett Guthrie (R-KY) to amend title XIX of the Social Security Act to eliminate the State option to reduce the home equity exemption amount for purposes of eligibility for long-term care assistance under Medicaid, and for other purposes. HR 3922 Championing Healthy Kids Act Introduced October 3, 2017 by Greg Walden (R-OR) Extends funding for the Childrens Health Insurance Program (CHIP) through Fiscal Year (FY)2022, Federally Qualified Health Centers (FQHCs) through FY2019 and revises CHIP and Medicaid. HR 2051 Fast Generics Act of 2017 Introduced April 6, 2017 by David McKinley (R-VA) to amend the Federal Food, Drug and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products and for other purposes. HR 2889 Closing Loopholes for Orphan Drugs Act Introduced June 13, 2017 by Peter Welch (D-VT) to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. HR 2212 CREATES Act introduced April 27, 2017 by Tom Marino (R-PA) to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Cancer Drug Parity Act of 2017 Introduced March 7, 2017 by Leonard Lance (R-NJ) to amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider. HR 749 Lower Drug Cost Through Competition Act Introduced January 30, 2017 by Kurt Schrder (D-OR) to increase competition in the pharmaceutical industry. HR 4666 Premium Relief Act Introduced December 18, 2017 by Ryan Costello (R-PA) To amend the Public Health Service Act to provide for a Patient and State Stability Fund. HR 3976 Access to Marketplace Insurance Act Introduced October 5, 2017 by Kevin Cramer (R-ND) to amend the Patient Protection and Affordable Care Act to allow for certain third-party payments. HR 6 SUPPORT for patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Way and Means Committee. HR 5752 Stop Illicit Drug Importation Act of 2018 introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administrations (FDA) seizure powers and enhance its authority to detain, refuse, seize or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess (R-TX) to require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain, drugs and for other purposes. HR 5811 Long-Term Opioid Efficacy Act of 2018 Introduced May 15, 2018 by Jerry McNerney (D-CA) to amend the Federal Food, Drug, and Cosmetic Act with respect to post approval study requirements for certain controlled substances, and for other purposes. HR 1925 At-Risk Youth Medicaid Protection Act of 2018 Introduced April 5, 2017 by Tony Cardenas (D-CA) to amend title XIX of the Social Security Act to protect at-risk youth against termination of Medicaid eligibility while an inmate of a public institution. HR 3192 CHIP Mental Health Parity Act to amend title XXI of the Social Security Act to ensure access to mental health services for children under the Childrens Health Insurance Program and for other purposes. HR 4005 Medicaid Reentry Act Directs the Secretary of Health and Human Services to convene a group of stakeholders and develop and report to Congress on best practices for addressing issues related to health care faced by those returning from incarceration to their communities. In addition, the legislation allows Medicaid payment for medical services furnished to an incarcerated individual during the 30-day period preceding the individuals release. HR 5789 Introduced May 15, 2018 by Bill Foster (D-IL) to amend title XIX of the Social Security Act to [provide for Medicaid coverage protection for pregnant and post-partum women while receiving inpatient treatment for substance use disorder, and for other purposes. HR 5797 Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act Introduced May 15, 2018 by Mimi Walters (D-CA) Allows state Medicaid programs to remove the Institutions for Mental Diseases (IMD) exclusion for Medicaid beneficiaries aged 21-64 with an opioid use disorder for fiscal years 2019 to 2023. By removing the exclusion, Medicaid would pay for up to 30 total days of care in an IMD during a 12-month period for eligible individuals. Opioid use disorder as defined in H.R. HR 5800 Introduced May 15, 2018 by Fred Upton (R-MI) directs the Medicaid and CHIP Payment and Access Commission (MACPAC) to conduct a study on institutions for mental disease that receive Medicaid reimbursement. The study shall report on the requirements and standards that state Medicaid programs have in place for institutions for mental diseases (IMD). MACPAC shall summarize the findings and make recommendations on best practices and data collection no later than January 2020. HR 5810 Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act Introduced May 15, 2018 by Leonard Lance (R-NJ) to amend title XIX of the Social Security Act to provide for an extension of the enhanced FMAP for certain Medicaid health homes for individuals with substance use disorders. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) to amend title XVII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) to amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) to require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids and for other purposes. HR 5590 Opioid Addiction Action Plan Introduced April 24, 2018 by Adam Kinzinger (R-IL) to require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment and for other purposes. HR 5603 Access to Telehealth Services for Substance Use Disorders Act Introduced April 24, 2018 by Doris Matsui (D-CA) to amend title XVIII of the Social Security Act to provide the Secretary of Health and Human Services Authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or co-occurring mental health disorder. HR 5605 Advancing Hight Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criterial such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extent to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates HR 3528 Every Prescription Conveyed Securely Act which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) to amend title XVII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventative physical examination. HR 5329 Poison Center Network Enhancement Act of 2018 Introduced March 19, 2018 by Susan Brooks (D-IN) reauthorizes the national network of Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Service Act. The Legislation increases the share of poison control center funding that could be provided through federal grants, and authorizes $30 million per year over the 2019-2023 period. HR 5804 Post Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) to amend title XVII of the Social Security act to provide for modifications in payment for certain outpatient surgical services. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) to amend title XVII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program and for other purposes. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the US Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12-18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across relevant Federal agencies, evaluate the effectiveness of these activities and make specific recommendations for actions that the agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting-Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health ne authorities to conduct research on innovative and non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment up to $250,000 for participants who agree to work as an SUD professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Rooms Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patients needs. The bill authorizes $50 million in FY 2019 for the grant program.

Client expense: $89,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA) Regulations; Opioid Epidemic; ACA Stabilization; Health Savings Accounts (HSAs); Cost Sharing Reductions (CSRs); Reinsurance; Market Stability; State Flexibility; Affordability; Risk Adjustment; Drug Pricing; Association Health Plans (AHPs); State 1332 Waivers; Small Group Market; Short Term Limited Duration Insurance (STLDI); Individual Market Rules HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD). This bill repeals a provision of the ACA that imposes an annual fee on a health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN). To repeal title I of the ACA and to amend the Public Health Service Act (PHSA) to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 2051 Introduced April 6, 2017 by David McKinley (R-WV). The FAST Generics Act amends the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR). To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. HR 1101 Introduced February 16, 2017 by Sam Johnson (R-TX). The Small Business Health Fairness Act of 2017 amends title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. HR 708 Introduced January 27,2017 by Larry Bucshon (R-IN). This bill amends the Public Health Service Act to increase the permissible variation based on age for health insurance premiums for coverage offered in the individual or small group market from a factor of three to a factor of five, or a factor determined by the state. HR 3922 Introduced October 3, 2017 by Greg Walden (R-OR). The Championing Healthy Kids Act extends funding for the Childrens Health Insurance Program (CHIP) through fiscal year (FY) 2022, Federally Qualified Health Centers (FQHCs) through FY 2019, and revises CHIP and Medicaid. HR 2889 Introduced June 13, 2017 by Peter Welch (D-VT). The Closing Loopholes for Orphan Drugs Act amends title III of the PHSA to limit the orphan drug exclusion under the drug discount program under section 340B of such title. HR 2212 Introduced April 27, 2017 by Tom Marino (R-PA). The CREATES Act promotes competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Introduced March 7, 2017 by Leonard Lance (R-NJ). The Cancer Drug Parity Act of 2017 amends the PHSA to require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider. HR 4666 Introduced December 18, 2017 by Ryan Costello (R-PA). The Premium Relief Act amends the PHSA to provide for a Patient State and Stability Fund. HR 3976 Introduced October 5, 2017 by Kevin Cramer (R-ND). The Access to Marketplace Insurance Act amends the ACA to allow for certain third-party payments. HR 6 Introduced June 13, 2018 by Greg Walden (R-OR). The SUPPORT for Patients and Communities Act includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 5806 Introduced May 15, 2018 by Michael Burgess (R-TX). The 21st Century Tools for Pain and Addiction Treatment Act requires the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 5811 Introduced May 15, 2018 by Jerry McNerney (D-CA). The Long-Term Opioid Efficacy Act of 2018 amends the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes. HR 3192 Introduced July 12, 2017 by Joseph Kennedy (D-MA). The CHIP Mental Health Parity Act amends title XXI of the Social Security Act to ensure access to mental health services for children under CHIP, and for other purposes. HR 5715 Introduced May 9, 2018 by James Renacci (R-OH). The Strengthening Partnerships to Avoid Opioid Abuse Act amends title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare Parts C and D. HR 5590 Introduced April 24, 2018 by Adam Kinzinger (R-IL). The Opioid Addiction Action Plan requires the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under the Medicare and Medicaid programs to prevent opioid addiction and enhance access to medication assisted treatment, and for other purposes. HR 5603 Introduced April 24, 2018 by Doris Matsui (D-CA). The Access to Telehealth Services for Substance Use Disorders Act amends title XVIII of the Social Security Act to provide the Secretary of Health and Human Services authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or a co-occurring mental health disorder. HR 5580 Introduced April 23, 2018 by Ann Kuster (D-NH). The STOP Fentanyl Deaths Act of 2018 authorizes the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5809 Introduced May 15, 2018 by Scott Peters (D-CA). The Postoperative Opioid Prevention Act of 2018 amends title XVIII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program, and for other purposes. HR 5795 Introduced May 15, 2018 by Earl Blumenauer (D-OR). The Overdose Prevention and Patient Safety Act amends the PHSA to protect the confidentiality of substance use disorder patient records. HR 5009 Introduced February 13, 2018 by Tim Walberg (R-MI). Jessies Law ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider.

Client expense: $410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) Issues related to Medicare and Medicaid coverage and reimbursement Issues related to the 340B Drug Discount Program Issues related to drug pricing Medicare reimbursement for biosimilars MACRA treatment and reimbursement of Part B drugs Medicare payments for inpatient antimicrobials Issues related to Right to Try Issues related to drug importation Issues related to Part D Medicare Program including coverage gap and other offsets

Client expense: $1,530,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 Issues related to the 340B Drug Discount Program Issues relating to drug pricing Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. General education about policies impacting pharmaceutical development, approval, reimbursement, and pricing. Issues related to healthcare legislation Issues related to public health protection including influenza development and preparedness

Client expense: $1,530,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 1892, Bipartisan Budget Act of 2018 Insurance market policies (Bipartisan Health Care Stabilization Act; S. 2052/H.R. 4200, Healthcare Market Certainty and Mandate Relief Act; H.R. 4666, the Premium Relief Act; 2019 Payment Notice Rule; Short-term, Limited Duration Health Insurance proposed rule; Association Health Plans proposed rule) Cost sharing reduction payments 340B Drug Pricing Program (H.R. 4392; H.R. 4710, 340B PAUSE Act; S. 2453, Ensuring the Value of the 340B Program Act; H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act; H.R. 2889, Closing Loopholes for Orphan Drugs Act; H.R. 5598, 340B Optimization Act; H.R. 6240, Drug Discount Accountability Act; H.R. 6273, Creating Access to Rape Kit Exams (CARE) for Survivors Act) Opioid issues (S. 2680, the Opioid Crisis Response Act of 2018; H.R. 5176, Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act; H.R. 5009, Jessies Law; H.R. 5818 / S. 2843, the Opioid Workforce Act; H.R. 5797, the IMD CARE Act; H.R. 5795, the Overdose Prevention and Patient Safety Act; S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act; S. 2460, Every Prescription Conveyed Securely Act; S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act; H.R. 5582, the Abuse Deterrent Access Act; H.R. 5685, the Medicare Opioid Safety Education Act; Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018; H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; S. 2899, Caring Recovery for Infants and Babies Act; S. 2898, Medication-Assisted Treatment Improvement Act; S.2911, Enhancing Patient Access to Non-Opioid Treatment Options) IV and medication shortages Drug prices (American Patients First, Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs) HIPAA policy in mental and behavioral health information sharing Pandemic and All Hazards Preparedness Reauthorization, including Hospital Preparedness Program (S. 2852, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2018) S.781/ HR 1876. Good Samaritan Health Professional Act of 2017 Health workforce reauthorizations (H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 3728, the Educating Medical Professionals and Optimizing Workforce Efficiency Readiness (EMPOWER) Act; H.R. 1676, the Palliative Care and Hospice Education and Training Act)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA); ACA Regulations; Opioid Epidemic; ACA Stabilization;; Health Savings Accounts (HSAs); Postal Reform; Cost Sharing Reductions (CSRs); Health Care Reform Reinsurance; Market Stability; State Flexibility; Pay-fors; Affordability; 1332 Templates; Healthcare Innovation; Risk Adjustment; Department Reform; Drug Pricing; Association Health Plans; Short Term Limited Duration; Air Ambulances; 42 CFR Part 2; Individual Market Reform; CREATES Act; Marketplace Certainty Act; Individual Market Rules; Small Group Market; Rural health; Health Information Technology HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on a health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN) To repeal title I of the Patient Protection and Affordable Care Act and to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 1703 Introduced March 23, 2017 by Morgan Griffith (R-VA) To amend the Federal Food, Drug, and Cosmetic Act with respect to determining the intended use of drugs and devices. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR) To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. HR 2026 Pharmaceutical Information Exchange Act Introduced April 6, 2017 by Brett Guthrie (R-VA) To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers. HR 1101 Small Business Health Fairness Act of 2017 Introduced February 16, 2017 by Sam Johnson (R-TX) To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. HR 2400 Introduced May 8, 2017 by Darrell Issa (R-CA) To amend title 5, United States Code, to allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program, and for other purposes. HR 180 To amend title XIX of the Social Security Act to eliminate the requirement for 3 months of retroactive coverage under the Medicaid program Introduced January 3, 2017 by Markwayne Mullin (R-OK) Under current law, a state Medicaid program must provide coverage for up to three months prior to an individual's application for benefits if the individual would have been eligible for benefits during that period. The bill eliminates this requirement and instead specifies that coverage begins in the month during which the individual applies for benefits. HR 708 Introduced January 27, 2017 by Larry Bucshon (R-IN) This bill amends the Public Health Service Act to increase the permissible variation based on age for health insurance premiums for coverage offered in the individual or small group market from a factor of three to a factor of five, or to a factor determined by the state. This applies to plan years starting on or after January 1, 2018. HR 829 Prioritizing the Most Vulnerable Over Lottery Winners Act of 2017 Introduced February 2, 2017 by Fed Upton (R-MI) This bill amends title XIX (Medicaid) to specify how a state must treat qualified lottery winnings and lump sum income for purposes of determining an individual's income-based eligibility for a state Medicaid program. Specifically, a state shall include such winnings or income as income received: (1) in the month in which it was received, if the amount is less than $80,000; (2) over a period of two months, if the amount is at least $80,000 but less than $90,000; (3) over a period of three months, if the amount is at least $90,000 but less than $100,000; and (4) over an additional one-month period for each increment of $10,000 received, not to exceed 120 months. HR 1082 Medicaid Home Improvement Act Introduced February 15, 2017 by Brett Guthrie (R-KY) To amend title XIX of the Social Security Act to eliminate the State option to reduce the home equity exemption amount for purposes of eligibility for long-term care assistance under Medicaid, and for other purposes. HR 1150 Tanning Tax Repeal of 2017 Introduced February 16, 2017 by George Holding (R-NC) To amend the Internal Revenue Code of 1986 to repeal the excise tax on indoor tanning services. HR 3922 Championing Healthy Kids Act Introduced October 3, 2017 by Greg Walden (R-OR) Extends funding for the Childrens Health Insurance Program (CHIP) through Fiscal Year (FY) 2022, Federally Qualified Health Centers (FQHCs) through FY2019, and revises CHIP and Medicaid. HR 2051 Fast Generics Act of 2017 Introduced April 6, 2017 by David McKinley (R-VA) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2889 Closing Loopholes for Orphan Drugs Act Introduced June 13, 2017 by Peter Welch (D-VT) To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. HR 2212 CREATES Act Introduced April 27, 2017 by Tom Marino (R-PA) To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Cancer Drug Parity Act of 2017 Introduced March 7, 2017 by Leonard Lance (R-NJ) To amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider. HR 749 Lower Drug Cost Through Competition Act Introduced January 30, 2017 by Kurt Schrader (D-OR) To increase competition in the pharmaceutical industry. HR 4666 Premium Relief Act Introduced December 18, 2017 by Ryan Costello (R-PA) To amend the Public Health Service Act to provide for a Patient and State Stability Fund. HR 3976 Access to Marketplace Insurance Act Introduced October 5, 2017 by Kevin Cramer (R-ND) To amend the Patient Protection and Affordable Care Act to allow for certain third-party payments. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 5228 SCREEN Act Introduced March 8, 2018 by Frank Pallone, Jr. (D-NJ) H.R. 5228 will provide the Food and Drug Administration (FDA) with stronger recall and seizure authority to disrupt the entry of counterfeit and illicit drugs through International Mail Facilities (IMFs). HR 5752 Stop Illicit Drug Importation Act of 2018 Introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administrations (FDA) seizure powers and enhance its authority to detain, refuse, seize, or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess(R-TX) To require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 5811 Long-Term Opioid Efficacy Act of 2018 Introduced May 15, 2018 by Jerry McNerney (D-CA) To amend the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes. HR 1925 At-Risk Youth Medicaid Protection Act of 2018 Introduced April 5, 2017 by Tony Cardenas (D-CA) To amend title XIX of the Social Security Act to protect at-risk youth against termination of Medicaid eligibility while an inmate of a public institution. HR 3192 CHIP Mental Health Parity Act To amend title XXI of the Social Security Act to ensure access to mental health services for children under the Children's Health Insurance Program, and for other purposes. HR 4005 Medicaid Reentry Act Directs the Secretary of Health and Human Services to convene a group of stakeholders and develop and report to Congress on best practices for addressing issues related to health care faced by those returning from incarceration to their communities. In addition, the legislation allows Medicaid payment for medical services furnished to an incarcerated individual during the 30-day period preceding the individuals release. HR 4998 Health Insurance for Former Foster Youth Act Introduced February 13, 2018 by Karen Bass (D-CA) To amend title XIX of the Social Security Act to ensure health insurance coverage continuity for former foster youth. HR 5477 Rural DOCS Act Introduced April 11, 2018 by Tom OHalleran (D-AZ) To amend title XIX of the Social Security Act to provide for a demonstration project to increase substance use provider capacity under the Medicaid program. HR 5583 Introduced April 23, 2018 by Yvette Clark (D-NY) requires states to include behavioral health indicators in their annual reports on the quality of care under Medicaid beginning in 2024. The Affordable Care Act (Section 1139B) requires the Secretary of HHS to identify and publish a core set of health care quality measures for adult Medicaid enrollees. The law requires that measures designated for the core set be currently in use. To aid in the assessment of the quality of care for Medicaid-eligible adults, the law calls for HHS to: develop a standardized reporting format for the core set of measures; establish an adult quality measurement program; issue an annual report by the Secretary on the reporting of adult Medicaid quality information; and publish updates to the initial core set of adult health quality measures that reflect new or enhanced quality measures. In the Center for Medicare and Medicaid Services 2018 Core Set of Adult Health Care Quality Measures for Medicaid, there are 11 behavioral health measures included. Under current law, states already voluntarily report many of these measures annually. HR 5789 Introduced May 15, 2018 by Bill Foster (D-IL) To amend title XIX of the Social Security Act to provide for Medicaid coverage protections for pregnant and post-partum women while receiving inpatient treatment for a substance use disorder, and for other purposes. HR 5797 Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act Introduced May 15, 2018 by Mimi Walters (D-CA) Allows state Medicaid programs to remove the Institutions for Mental Diseases (IMD) exclusion for Medicaid beneficiaries aged 21 to 64 with an opioid use disorder for fiscal years 2019 to 2023. By removing the exclusion, Medicaid would pay for up to 30 total days of care in an IMD during a 12-month period for eligible individuals. Opioid use disorder as defined in H.R. 5797 includes, but is not limited to: heroin, fentanyl, oxycodone, tramadol and oxycodone. In addition, the legislation requires states to include in their State plan amendment information on 1) How the State will improve access to outpatient care during the State plan amendment period. 2) The process for transitioning individuals to appropriate. HR 5799 Medicaid Drug Review, Utilization, Good Governance Improvement Act Introduced May 15, 2018 by Marsha Blackburn (R-TN) To amend title XIX of the Social Security Act to require as a condition of receipt of full Federal medical assistance percentage under Medicaid that State Medicaid plans have in place certain drug utilization review activities. HR 5800 Introduced May 15, 2018 by Fred Upton (R-MI) directs the Medicaid and CHIP Payment and Access Commission (MACPAC) to conduct a study on institutions for mental disease that receive Medicaid reimbursement. The study shall report on the requirements and standards that state Medicaid programs have in place for institutions for mental diseases (IMD). MACPAC shall summarize the findings and make recommendations on best practices and data collection no later than January 2020. HR 5801 Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act Introduced May 15, 2018 by Morgan Griffith (R-VA) To amend title XIX of the Social Security Act to provide for requirements under the Medicaid program relating to the use of qualified prescription drug monitoring programs and prescribing certain controlled substances. HR 5808 Medicaid Pharmaceutical Home Act of 2018 Introduced May 15, 2018 by Gus Bilirakis (R-FL) To amend title XIX of the Social Security Act to require States to operate drug management programs for at-risk beneficiaries, and for other purposes. HR 5810 Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act Introduced May 15, 2018 by Leonard Lance (R-NJ) To amend title XIX of the Social Security Act to provide for an extension of the enhanced FMAP for certain Medicaid health homes for individuals with substance use disorders. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) To amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) To amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids, and for other purposes. HR 5590 Opioid Addiction Action Plan Act Introduced April 24, 2018 by Adam Kinzinger (R-IL) To require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment, and for other purposes. HR 5603 Access to Telehealth Services for Substance Use Disorders Act Introduced April 24, 2018 by Doris Matsui (D-CA) To amend title XVIII of the Social Security Act to provide the Secretary of Health and Human Services authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or co-occurring mental health disorder. HR 5605 Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criteria such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extent to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates H.R. 3528, Every Prescription Conveyed Securely Act, which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) To amend title XVIII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examination. HR 4684 Ensuring Access to Quality Sober Living Act of 2018 Introduced December 19, 2017 by Judy Chu (D-CA) Authorizes the Substance Abuse and Mental Health Services Administration to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment and sustained recovery from substance use disorders. Recovery housing is increasingly recognized as critical to recovery for many individuals, and includes activities and programs such as mediation, one-on-one counseling, group sessions, peer recovery support, medication management, spiritual engagement, and others. HR 5329 Poison Center Network Enhancement Act of 2018 Introduced March 19, 2018 by Susan Brooks (D-IN) reauthorizes the national network of Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Service Act. The legislation increases the share of poison control center funding that could be provided through federal grants, and authorizes $30 million per year over the 2019-2023 period. HR 5580 STOP Fentanyl Deaths Act of 2018 Introduced April 23, 2018 by Ann Kuster (D-NH) To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5587 Peer Support Communities of Recovery Act Introduced April 23, 2018 by Ben Lujan (D-NM) enhances the Comprehensive Addiction and Recovery Acts Building Communities of Recovery Program and authorizes the Department of Health and Human Services (HHS) to award grants to peer support specialist organizations for the development and expansion of recovery services. Grants shall be awarded to nonprofit organizations that support community-based, peer delivered support, including technical support for the establishment of recovery community organizations, independent, nonprofit groups led by people in recovery and their families. HR 5804 Post-Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) To amend title XVIII of the Social Security Act to provide for modifications in payment for certain outpatient surgical services. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) To amend title XVIII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program, and for other purposes. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) To amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) Will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness Act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the U.S. Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12 to 18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across all relevant Federal agencies, evaluate the effectiveness of these activities, and make specific recommendations for actions that agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health new authorities to conduct research on innovative non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment of up to $250,000 for participants who agree to work as a SUD treatment professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Rooms Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patients needs. The bill authorizes $50 million in FY2019 for the grant program. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Vice President of the U.S., White House Office

S.3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2019, Medical Center related initiatives; and Opioid related issues Medical Center related initiatives H.R.4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes, 340B issues H.R.4710, 340B Protecting Access for the Underserved and Safety-net Entities (PAUSE) Act, generally S.2453, Ensuring the Value of the 340B Program Act of 2018, generally H.R.2889, Closing Loopholes for Orphan Drugs Act, generally S.2312, Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act, generally S.356/H.R.1027, Hallways to Health Act, generally H.R.5150, Protecting Medicare from Excessive Price Increases Act of 2018, generally H.R.5598, 340B Optimization Act, generally H.R.6071, Stretching Entity Resources for Vulnerable (SERV) Communities Act, generally H.R.5498, Rural Hospital Frontier Fairness Act, generally

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

340B Drug Discount Program Resident Physician Shortage Reduction Act Graduate Medical Education Disproportionate Share Hospital payments Childrens Health Insurance Program Medicare Dependent Hospital Program (MDH) Medicaid Low Volume Payments (LV) H.R. 1955, S. 872 - Rural Hospital Access Act H.R. 2889, Closing Loopholes for Orphan Drugs Act Medicare Wage Index Federal Medical Assistance Percentage Extension Inpatient Prospective Payment System Outpatient Prospective Payment System Bad debt/charity care Hospital Outpatient Department payments H.R. 4392, Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems 340B Drug Discount program legislation H.R. 4710, 340B PAUSE Act S. 2453, Ensuring the Value of the 340B Program Act

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA) Regulations; Postal Reform; Health Care Reform; Reinsurance; CSRs (Cost Sharing Reductions); Implementation; Drug Pricing; Individual Market Reform; Market Stabilization; AHPs (Association Health Plans); Waivers; Small Group Market Reform; STLD (Short Term Limited Duration); HIT (Health Insurance Tax); 2018 Direct Consumer Benefit; Grace Periods; Third Party Payment of Premiums; SEPs (Special Enrollment Periods); Catastrophic Coverage Beyond Age 30; Tax Credits; Graham-Cassidy Legislation; Collins-Nelson Legislation; Alexander-Murray Legislation. H.R. 4163 -- 115th Congress (2017-2018) S.1354 -- 115th Congress (2017-2018) Individual Health Insurance Marketplace Improvement Act Sponsor: Sen. Carper, Thomas R. [D-DE] (Introduced 06/14/2017) S.2221 -- 115th Congress (2017-2018) Postal Service Reform Act of 2017 Sponsor: Rep. Chaffetz, Jason [R-UT-3] (Introduced 01/31/2017) H.R. 246 -- 115th Congress (2017-2018) To Repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act. Sponsor: Rep. Noem, Kristi L. [R-SD-At Large] (Introduced 01/04/2017) H.R.2575 -- 115th Congress (2017-2018) BENES Act of 2017 Sponsr: Rep. Ruiz, Raul [D-CA-36] (Introduced 05/19/2017) 1.H.R.2430 -- 115th Congress (2017-2018) FDA Reauthorization Act of 2017 1.H.R.314 -- 115th Congress (2017-2018) Health Care Choice Act of 2017 1.H.R. 2051 -- 115th Congress (2017-2018) FAST Generics Act of 2017 H.R.4666 -- 115th Congress (2017-2018) Premium Relief Act of 2017 Exchange Act 1.H.R.1101 -- 115th Congress (2017-2018) Small Business Health Fairness Act of 2017 1.H.R.2400 -- 115th Congress (2017-2018) To amend Title 5, United States Code, to allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program, and for other purposes. 1.H.R.708 -- 115th Congress (2017-2018) State Age Rating Flexibility Act of 2017 1.H.R.2889 -- 115th Congress (2017-2018) Closing Loopholes for Orphan Drugs Act 1.H.R.2212 -- 115th Congress (2017-2018) CREATES Act of 2017 1.H.R.1409 -- 115th Congress (2017-2018) Cancer Drug Parity Act of 2017 1.H.R.749 -- 115th Congress (2017-2018) Lower Drug Costs through Competition Act 1.H.R.4666 -- 115th Congress (2017-2018) Premium Relief Act of 2017 1.H.R.3976 -- 115th Congress (2017-2018) Access to Marketplace Insurance Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program Resident Physician Shortage Reduction Act Graduate Medical Education Disproportionate Share Hospital payments Childrens Health Insurance Program Medicare Dependent Hospital Program (MDH) Medicaid Low Volume Payments (LV) H.R. 1955, S. 872 - Rural Hospital Access Act H.R. 2889, Closing Loopholes for Orphan Drugs Act Medicare Wage Index Federal Medical Assistance Percentage Extension Inpatient Prospective Payment System Outpatient Prospective Payment System Bad debt/charity care Hospital Outpatient Department payments H.R. 4392, Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems 340B Drug Discount program legislation H.R. 4710, 340B PAUSE Act S. 2453, Ensuring the Value of the 340B Program Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA) Regulations; Postal Reform; Health Care Reform; Reinsurance; CSRs (Cost Sharing Reductions); Implementation; Special Needs Plans (SNP); Drug Pricing; Individual Market Reform; Market Stabilization; AHPs (Association Health Plans; Waivers; Small Group Market Reform; STLD (Short Term Limited Duration); HIT (Health Insurance Tax); 2018 Direct Consumer Benefit; Grace Periods; Third party Payment of Premiums; SEPs (Special Enrollment Periods); Catastrophic Coverage beyond age 30; Tax Credits; Graham-Cassidy Legislation; Collins-Nelson Legislation; Alexander-Murray Legislation; MSP (Multi State Plans); SNP (Special Needs Plans); Data Breach reporting standards; Application of NCPDP Subrogation standard; Part 2 substance use disorder regulation; Interoperability (Electronic Health Records) H.R.4163 - 115th Congress (2017-2018) Cyber Shield Act of 2017 Sponsor: Rep. Lieu, Ted [D-CA-33] (Introduced 10/27/2017) S.1354 - 115th Congress (2017-2018) Individual Health Insurance Marketplace Improvement Act Sponsor: Sen. Carper, Thomas R. [D-DE] (Introduced 06/14/2017) S.2221- 115th Congress (2017-2018) RIP MSP Act Sponsor: Sen. Johnson, Ron [R-WI] (Introduced 12/12/2017) H.R.756 - 115th Congress (2017-2018) Postal Service Reform Act of 2017 Sponsor: Rep. Chaffetz, Jason [R-UT-3] (Introduced 01/31/2017 H.R.173 - 115th Congress (2017-2018) Middle Class Health Benefits Tax Repeal Act of 2017Sponsor: Rep. Kelly, Mike [R-PA-3] (Introduced 01/03/2017) H.R.246 - 115th Congress (2017-2018) To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act.Sponsor: Rep. Noem, Kristi L. [R-SD-At Large] (Introduced 01/04/2017) H.R.2575 - 115th Congress (2017-2018) BENES Act of 2017Sponsor: Rep. Ruiz, Raul [D-CA-36] (Introduced 05/19/2017) 1. H.R.2430 - 115th Congress (2017-2018) FDA Reauthorization Act of 2017 1. H.R.314 - 115th Congress (2017-2018) Health Care Choice Act of 2017 1. H.R.2051 - 115th Congress (2017-2018) FAST Generics Act of 2017 1. H.R.1703 - 115th Congress (2017-2018) Medical Product Communications Act of 2017 1. H.R.2026 - 115th Congress (2017-2018) Pharmaceutical Informa1. H.R.4666 - 115th Congress (2017-2018) Premium Relief Act of 2017tion Exchange Act 1. H.R.1101 - 115th Congress (2017-2018) Small Business Health Fairness Act of 2017 1. H.R.2400 - 115th Congress (2017-2018) To amend title 5, United States Code, to allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program, and for other purposes. 1. H.R.180 - 115th Congress (2017-2018) To amend title XIX of the Social Security Act to eliminate the requirement for 3 months of retroactive coverage under the Medicaid program. 1. H.R.708 - 115th Congress (2017-2018) State Age Rating Flexibility Act of 2017 1. H.R.829 - 115th Congress (2017-2018) Prioritizing the Most Vulnerable Over Lottery Winners Act of 2017 1. H.R.1082 - 115th Congress (2017-2018) Medicaid HOME Improvement Act 1. H.R.1150 - 115th Congress (2017-2018) Tanning Tax Repeal Act of 2017 1. H.R.3922 - 115th Congress (2017-2018) CHAMPIONING HEALTHY KIDS Act 1. H.R.2889 - 115th Congress (2017-2018) Closing Loopholes for Orphan Drugs Act 1. H.R.2212 - 115th Congress (2017-2018) CREATES Act of 2017 1. H.R.1409 - 115th Congress (2017-2018) Cancer Drug Parity Act of 2017 1. H.R.749 - 115th Congress (2017-2018) Lower Drug Costs through Competition Act 1. H.R.4666 - 115th Congress (2017-2018) Premium Relief Act of 2017 1. H.R.3976 - 115th Congress (2017-2018) Access to Marketplace Insurance Act

Client expense: $1,830,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Vice President of the U.S., White House Office

Affordable Care Act (ACA) Regulations; Health Care Reform; Reinsurance; CSRs (Cost Sharing Reductions); Implementation; Special Needs Plans (SNP); Drug Pricing; Individual Market Reform; Market Stabilization; AHPs (Association Health Plans; Waivers; Small Group Market Reform; STLD (Short Term Limited Duration); HIT (Health Insurance Tax); 2018 Direct Consumer Benefit; Grace Periods; Third party Payment of Premiums; SEPs (Special Enrollment Periods); Catastrophic Coverage beyond age 30; Tax Credits; Graham-Cassidy Legislation; Collins-Nelson Legislation; Alexander-Murray Legislation; MSP (Multi State Plans); SNP (Special Needs Plans) S.1354 - 115th Congress (2017-2018). Individual Health Insurance Marketplace Improvement Act. Sponsor: Sen. Carper, Thomas R. [D-DE] (Introduced 06/14/2017) S.2221- 115th Congress (2017-2018). RIP MSP Act. Sponsor: Sen. Johnson, Ron [R-WI] (Introduced 12/12/2017) H.R.173 - 115th Congress (2017-2018). Middle Class Health Benefits Tax Repeal Act of 2017. Sponsor: Rep. Kelly, Mike [R-PA-3] (Introduced 01/03/2017) H.R.246 - 115th Congress (2017-2018. To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act. Sponsor: Rep. Noem, Kristi L. [R-SD-At Large] (Introduced 01/04/2017) H.R.2575 - 115th Congress (2017-2018). BENES Act of 2017. Sponsor: Rep. Ruiz, Raul [D-CA-36] (Introduced 05/19/2017) 1. H.R.2430 - 115th Congress (2017-2018). FDA Reauthorization Act of 2017. 1. H.R.314 - 115th Congress (2017-2018). Health Care Choice Act of 2017. 1. H.R.2051 - 115th Congress (2017-2018). FAST Generics Act of 2017. 1. H.R.1703 - 115th Congress (2017-2018). Medical Product Communications Act of 2017. 1. H.R.2026 - 115th Congress (2017-2018). Pharmaceutical Information Exchange Act. 1. H.R.4666 - 115th Congress (2017-2018). Premium Relief Act of 2017. 1. H.R.1101 - 115th Congress (2017-2018). Small Business Health Fairness Act of 2017. 1. H.R.2400 - 115th Congress (2017-2018). To amend title 5, United States Code, to allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program, and for other purposes. 1. H.R.180 - 115th Congress (2017-2018). To amend title XIX of the Social Security Act to eliminate the requirement for 3 months of retroactive coverage under the Medicaid program. 1. H.R.708 - 115th Congress (2017-2018). State Age Rating Flexibility Act of 2017. 1. H.R.1082 - 115th Congress (2017-2018). Medicaid HOME Improvement Act. 1. H.R.3922 - 115th Congress (2017-2018). CHAMPIONING HEALTHY KIDS Act. 1. H.R.2889 - 115th Congress (2017-2018). Closing Loopholes for Orphan Drugs Act. 1. H.R.2212 - 115th Congress (2017-2018). CREATES Act of 2017. 1. H.R.1409 - 115th Congress (2017-2018). Cancer Drug Parity Act of 2017. 1. H.R.749 - 115th Congress (2017-2018). Lower Drug Costs through Competition Act. 1. H.R.4666 - 115th Congress (2017-2018). Premium Relief Act of 2017. 1. H.R.3976 - 115th Congress (2017-2018). Access to Marketplace Insurance Act.

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

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

Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2019, Medical Center related initiatives Medical Center related initiatives Public Law 115-96, Further Additional Continuing Appropriations Act, FY2018, CHIP and Community Health Center H.R.4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes, 340B issues Public Law 115-123, Bipartisan Budget Act of 2018, Medical Center issues H.R.4710, 340B Protecting Access for the Underserved and Safety-net Entities (PAUSE) Act, generally S.2453, Ensuring the Value of the 340B Program Act of 2018, generally H.R.2889, Closing Loopholes for Orphan Drugs Act, generally H.R.2312, Enhanced Veteran Healthcare Act of 2017, generally S.356/H.R.1027, Hallways to Health Act, generally H.R.5150, Protecting Medicare from Excessive Price Increases Act of 2018, generally

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA) Regulations; Postal Reform; Health Care Reform; Reinsurance; CSRs (Cost Sharing Reductions); Implementation; Special Needs Plans (SNP); Drug Pricing; Individual Market Reform; Market Stabilization; AHPs (Association Health Plans; Waivers; Small Group Market Reform; STLD (Short Term Limited Duration); HIT (Health Insurance Tax); 2018 Direct Consumer Benefit; Grace Periods; Third party Payment of Premiums; SEPs (Special Enrollment Periods); Catastrophic Coverage beyond age 30; Tax Credits; Graham-Cassidy Legislation; Collins-Nelson Legislation; Alexander-Murray Legislation H.R.173 - 115th Congress (2017-2018) Middle Class Health Benefits Tax Repeal Act of 2017Sponsor: Rep. Kelly, Mike [R-PA-3] (Introduced 01/03/2017) H.R.246 - 115th Congress (2017-2018) To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act.Sponsor: Rep. Noem, Kristi L. [R-SD-At Large] (Introduced 01/04/2017) H.R.2575 - 115th Congress (2017-2018) BENES Act of 2017Sponsor: Rep. Ruiz, Raul [D-CA-36] (Introduced 05/19/2017) 1. H.R.2430 - 115th Congress (2017-2018) FDA Reauthorization Act of 2017 1. H.R.314 - 115th Congress (2017-2018) Health Care Choice Act of 2017 1. H.R.2051 - 115th Congress (2017-2018) FAST Generics Act of 2017 1. H.R.1703 - 115th Congress (2017-2018) Medical Product Communications Act of 2017 1. H.R.2026 - 115th Congress (2017-2018) Pharmaceutical Informa1. H.R.4666 - 115th Congress (2017-2018) Premium Relief Act of 2017tion Exchange Act 1. H.R.1101 - 115th Congress (2017-2018) Small Business Health Fairness Act of 2017 1. H.R.2400 - 115th Congress (2017-2018) To amend title 5, United States Code, to allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program, and for other purposes. 1. H.R.180 - 115th Congress (2017-2018) To amend title XIX of the Social Security Act to eliminate the requirement for 3 months of retroactive coverage under the Medicaid program. 1. H.R.708 - 115th Congress (2017-2018) State Age Rating Flexibility Act of 2017 1. H.R.829 - 115th Congress (2017-2018) Prioritizing the Most Vulnerable Over Lottery Winners Act of 2017 1. H.R.1082 - 115th Congress (2017-2018) Medicaid HOME Improvement Act 1. H.R.1150 - 115th Congress (2017-2018) Tanning Tax Repeal Act of 2017 1. H.R.3922 - 115th Congress (2017-2018) CHAMPIONING HEALTHY KIDS Act 1. H.R.2889 - 115th Congress (2017-2018) Closing Loopholes for Orphan Drugs Act 1. H.R.2212 - 115th Congress (2017-2018) CREATES Act of 2017 1. H.R.1409 - 115th Congress (2017-2018) Cancer Drug Parity Act of 2017 1. H.R.749 - 115th Congress (2017-2018) Lower Drug Costs through Competition Act 1. H.R.4666 - 115th Congress (2017-2018) Premium Relief Act of 2017 1. H.R.3976 - 115th Congress (2017-2018) Access to Marketplace Insurance Act

Client expense: $1,740,000 · Firm income: Not reported

Government targets: 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), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Vice President of the U.S., White House Office

340B Drug Discount Program Resident Physician Shortage Reduction Act Graduate Medical Education Disproportionate Share Hospital payments Childrens Health Insurance Program Medicare Dependent Hospital Program (MDH) Medicaid Low Volume Payments (LV) H.R. 1955, S. 872 - Rural Hospital Access Act H.R. 2889, Closing Loopholes for Orphan Drugs Act Medicare Wage Index Federal Medical Assistance Percentage Extension Inpatient Prospective Payment System Outpatient Prospective Payment System Bad debt/charity care Hospital Outpatient Department payments H.R. 4392, Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems 340B Drug Discount program legislation H.R. 4710, 340B PAUSE Act

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program Resident Physician Shortage Reduction Act Graduate Medical Education Disproportionate Share Hospital payments Childrens Health Insurance Program Medicare Dependent Hospital Program (MDH) Medicaid Low Volume Payments (LV) H.R. 1955, S. 872 - Rural Hospital Access Act H.R. 2889, Closing Loopholes for Orphan Drugs Act Medicare Wage Index Federal Medical Assistance Percentage Extension Inpatient Prospective Payment System Outpatient Prospective Payment System Bad debt/charity care Hospital Outpatient Department payments

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor timing and content for upcoming Corporate Tax Reform, and Budget Reconciliation, and Debt Limit. Review of House Republican Blueprint Monitor H.R. 2889/ S. 1686 on Carried Interest. Continue monitoring potential tax items such as state/local taxes, interest deductibility, and advertising. Review and monitor any Senate tax plan, and Trump Administration tax speeches such as Sec of Treasury Mnuchin, and Nat Economic Counsel Director Cohn. Continue visits to Ways and Means and Finance tax LAs. Preparations for 2018 Budget Resolution in the House and Senate.

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

340B Drug Discount Program Resident Physician Shortage Reduction Act Graduate Medical Education Disproportionate Share Hospital payments H.R. 2889, Closing Loopholes for Orphan Drugs Act Medicare Wage Index Federal Medical Assistance Percentage Extension Inpatient Prospective Payment System Outpatient Prospective Payment System Bad debt/charity care Hospital Outpatient Department payments

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE